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1,300 | 27,838,164 | Conclusions : There is moderate‐ quality evidence supporting the use of chlorhexidine for preoperative skin antisepsis and high‐ quality evidence that the use of chlorhexidine is associated with fewer positive skin cultures . | HighlightsSurgical site infection is one of the most frequent health care – associated infections .
It is not clear if one antiseptic is better than any other prior to surgery .
A review of literature shows results in favor of chlorhexidine .
Background : Surgical site infection ( SSI ) is one of the most frequent health care – associated infections .
One of the practice s to reduce their incidence is preoperative skin antisepsis .
Two of the most commonly active components used are chlorhexidine gluconate and povidone iodine .
Purpose : To verify whether recent evidence supports the hypothesis that chlorhexidine in preoperative antisepsis is more efficient than other antiseptics in reducing SSI rates . | BACKGROUND Since the patient 's skin is a major source of pathogens that cause surgical-site infection , optimization of preoperative skin antisepsis may decrease postoperative infections . We hypothesized that preoperative skin cleansing with chlorhexidine-alcohol is more protective against infection than is povidone-iodine . METHODS We r and omly assigned adults undergoing clean-contaminated surgery in six hospitals to preoperative skin preparation with either chlorhexidine-alcohol scrub or povidone-iodine scrub and paint . The primary outcome was any surgical-site infection within 30 days after surgery . Secondary outcomes included individual types of surgical-site infections . RESULTS A total of 849 subjects ( 409 in the chlorhexidine-alcohol group and 440 in the povidone-iodine group ) qualified for the intention-to-treat analysis . The overall rate of surgical-site infection was significantly lower in the chlorhexidine-alcohol group than in the povidone-iodine group ( 9.5 % vs. 16.1 % ; P=0.004 ; relative risk , 0.59 ; 95 % confidence interval , 0.41 to 0.85 ) . Chlorhexidine-alcohol was significantly more protective than povidone-iodine against both superficial incisional infections ( 4.2 % vs. 8.6 % , P=0.008 ) and deep incisional infections ( 1 % vs. 3 % , P=0.05 ) but not against organ-space infections ( 4.4 % vs. 4.5 % ) . Similar results were observed in the per- protocol analysis of the 813 patients who remained in the study during the 30-day follow-up period . Adverse events were similar in the two study groups . CONCLUSIONS Preoperative cleansing of the patient 's skin with chlorhexidine-alcohol is superior to cleansing with povidone-iodine for preventing surgical-site infection after clean-contaminated surgery . ( Clinical Trials.gov number , NCT00290290 . Abstract Povidone-iodine and chlorhexidine surgical scrub and skin preparation solutions were assessed by comparing postoperative wound infection rates in a prospect i ve , r and omized study of 866 patients . The frequency of wound infection overall , as agreed by two observers , was 14·8 per cent in the povidone-iodine group and 9·7 per cent in the chlorhexidine group ( P = 0·03 ) at the time of patients ' discharge from hospital . The difference between the compounds was not significant at a ‘ st and ard ' observation period of three to four days after operation . There were significantly fewer infections with chlorhexidine than with povidone-iodine in operations on the biliary tract and in ‘ clean ' non-abdominal operations , but there were more infections ( not significantly so ) with chlorhexidine than with povidoneiodine in large bowel surgery , other laparotomies and in operations on hernia , genitalia and varicose veins . The differences in bacterial isolates from wounds tended to follow the above patterns . We conclude that , on the evidence of this study , there is no overwhelming case for using one compound rather than the other as an all- purpose preparation and scrub OBJECTIVE We estimated the impact of hip replacement-associated surgical site infection ( SSI ) on morbidity and length of stay . METHODS This was a pairwise matched ( 1 : 1 ) case-control study nested in a cohort . All patients who underwent hip replacement from January 1 , 2000 , to June 30 , 2004 , were prospect ively enrolled for the nested case-control design analysis and were monitored from the time of surgery until hospital discharge , including any patients readmitted because of infection . RESULTS Among the 1,260 hip replacements performed , 28 SSIs were detected , yielding a crude SSI rate of 2.2 % . The median excess length of stay attributable to SSI was 32.5 days ( P<.001 ) , whereas the median prolonged postoperative stay due to SSI was 31 days ( P<.001 ) . Deep-wound SSI was the type that prolonged hospital stay the most ( up to 49 days ) . Of the patients who developed an SSI , 4 required revision surgery , for an SSI-related morbidity rate of 14.3 % . CONCLUSION SSI prolongs hospital stay ; however , although hospital stay is a rough indicator of the cost of this complication , to accurately estimate the costs of SSI , we would need to consider individual costs in a linear regression model adjusted for all possible confounding factors OBJECTIVE To analyze the incidence of surgical site infection when the preoperative skin preparation was performed with 10 % povidone-iodine and 0.5 % chlorhexidine-alcohol . METHODS We conducted a r and omized , longitudinal study based on variables obtained from patients undergoing clean and potentially contaminated operations . Those involved were divided into two groups . In group 1 ( G1 ) we included 102 patients with skin prepared with povidone-iodine , and in group 2 ( G2 ) , 103 , whose skin was prepared with chlorhexidine . In the third , seventh and 30th postoperative days we evaluated the surgical site , search ing for signs of infection . RESULTS Data related to clinical profile , such as diabetes mellitus , smoking , alcoholism , haematological data ( Hb , VG and leukocytes ) , age and gender , and the related variables , such as number of days of preoperative hospitalization , shaving , topography of incision , antibiotic prophylaxis and resident participation in the operation were not predisposing factors for surgical site infection . Two patients in G1 and eight in G2 undergoing clean operations had some type of infection ( p = 0.1789 ) , five in G1 and three in G2 undergoing potentially contaminated operations had some type of infection ( p = 0.7205 ) . CONCLUSION The incidence of surgical site infection in operations classified as clean and as potentially contaminated for which skin preparation was done with 10 % povidone-iodine and 0.5 % chlorhexidine-alcohol was similar Abstract Background / Aims : To compare the prevalence of positive bacterial cultures at the cesarean delivery ( CD ) incision site in patients with pre-operative application of chlorhexidine gluconate ( CG ) versus povidone iodine ( PI ) . Methods : Women undergoing a scheduled CD at ≥36 gestational weeks were r and omly assigned to receive CG or PI . A swab of the incision site was performed at 3 min after disinfectant application and at 18 post-operative hours , and the prevalence of cultures with any detected bacterial growth was compared for the two groups . Results : Of the 60 participants , 33 ( 55.0 % ) were in the PI group . There were no differences detected at 3 min , with 9.1 % positive in the PI group versus 0 % positive in the CG group ( p = 0.2499 ) . However , at 18 h , women in the PI group were seven times more likely than women in the CG group to have a positive culture ( 16/33 [ 48.5 % ] versus 3/27 [ 11.1 % ] , OR = 7.53 [ 95 % CI 1.67–38.83 ] , p = 0.0023 ) . Multivariate logistic regression demonstrated similar results : OR = 7.33 ( 95 % CI 1.77–30.35 ) , p = 0.0060 . Conclusion : The prevalence of positive bacterial cultures obtained at the site of the skin incision 18 h after CD was higher in the PI versus the CG group BACKGROUND Postoperative spinal wound infections are relatively common and are often associated with increased morbidity and poor long-term patient outcomes . The purpose s of this study were to identify the common bacterial flora on the skin overlying the lumbar spine and evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation . METHODS A prospect i ve r and omized study was undertaken to evaluate 100 consecutive patients undergoing elective lumbar spine surgery . At the time of surgery , the patients were r and omized to be treated with one of two widely used , and Food and Drug Administration ( FDA ) -approved , surgical skin-preparation solutions : ChloraPrep ( 2 % chlorhexidine gluconate and 70 % isopropyl alcohol ) or DuraPrep ( 0.7 % available iodine and 74 % isopropyl alcohol ) . Specimens for aerobic and anaerobic cultures were obtained prior to skin preparation ( pre-preparation ) , after skin preparation ( post-preparation ) , and after wound closure ( post-closure ) . A vali date d neutralization solution was used for each culture to ensure that the antimicrobial activity was stopped immediately after the sample was taken . Positive cultures and specific bacterial pathogens were recorded . RESULTS Coagulase-negative Staphylococcus , Propionibacterium acnes , and Corynebacterium were the most commonly isolated organisms prior to skin preparation . The overall rate of positive cultures prior to skin preparation was 82 % . The overall rate of positive cultures after skin preparation was 0 % ( zero of fifty ) in the ChloraPrep group and 6 % ( three of fifty ) in the DuraPrep group ( p = 0.24 , 95 % confidence interval [ CI ] = 0.006 to 0.085 ) . There was an increase in positive cultures after wound closure , but there was no difference between the ChloraPrep group ( 34 % , seventeen of fifty ) and the DuraPrep group ( 32 % , sixteen of fifty ) ( p = 0.22 , 95 % CI = 0.284 to 0.483 ) . Body mass index ( BMI ) , duration of surgery , and estimated blood loss did not a show significant association with post-closure positive culture results . CONCLUSIONS ChloraPrep and DuraPrep are equally effective skin-preparation solutions for eradication of common bacterial pathogens on the skin overlying the lumbar spine OBJECTIVE The purpose of this study was to compare the efficacy of chlorhexidine and povidone iodine for cleansing the operative field for vaginal surgery . STUDY DESIGN This was a r and omized controlled trial that compared 10 % povidone iodine and 4 % chlorhexidine gluconate as surgical scrubs . Our primary end point was the proportion of contaminated specimens ( defined as total bacterial colony counts of > /=5000 colony-forming units ) per group found throughout the surgical procedures . All patients received st and ard infection prophylaxis that included preoperative intravenous antibiotics . Immediately before antibiotic administration and baseline aerobic and anaerobic cultures of the vaginal flora were obtained , which were followed by cultures at 30 minutes after the surgical scrub and hourly thereafter throughout each patient 's surgery . RESULTS A total of 50 patients were enrolled between October 2002 and September 2003 . There were no differences between the povidone iodine ( n = 27 ) and chlorhexidine ( n = 23 ) groups with respect to age , race , exogenous hormone use , body mass index , gravity , parity , preoperative mean colony counts , or operative time . Among the first set of intraoperative specimens ( which were obtained 30 minutes after the surgical scrub ) , 63 % of the cultures ( 17/27 ) from the povidone iodine group and 22 % of the cultures ( 5/23 ) from the chlorhexidine group were classified as contaminated ( P = .003 ; relative risk , 6.12 ; 95 % CI , 1.7 , 21.6 ) . Subsequent cultures failed to demonstrate significant differences . CONCLUSION Chlorhexidine gluconate was more effective than povidone iodine in decreasing the bacterial colony counts that were found in the operative field for vaginal hysterectomy Background Surgical site infections ( SSI ) remain a major clinical problem in terms of morbidity , mortality , and hospital costs . Nearly 60 % of SSI diagnosis occur in the postdischarge period . However , literature provides little information on risk factors associated to in-hospital and postdischarge SSI occurrence . A national prospect i ve multicenter study was conducted with the aim of assessing the incidence of both in-hospital and postdisharge SSI , and the associated risk factors . Methods In 2002 , a one-month , prospect i ve national multicenter surveillance study was conducted in General and Gynecological units of 48 Italian hospitals . Case ascertainment of SSI was carried out using st and ardized surveillance methodology . To assess potential risk factors for SSI we used a conditional logistic regression model . We also reported the odds ratios of in-hospital and postdischarge SSI . Results SSI occurred in 241 ( 5.2 % ) of 4,665 patients , of which 148 ( 61.4 % ) during in-hospital , and 93 ( 38.6 % ) during postdischarge period . Of 93 postdischarge SSI , sixty-two ( 66.7 % ) and 31 ( 33.3 % ) were detected through telephone interview and question naire survey , respectively . Higher SSI incidence rates were observed in colon surgery ( 18.9 % ) , gastric surgery ( 13.6 % ) , and appendectomy ( 8.6 % ) . If considering risk factors for SSI , at multivariate analysis we found that emergency interventions , NNIS risk score , pre-operative hospital stay , and use of drains were significantly associated with SSI occurrence . Moreover , risk factors for total SSI were also associated to in-hospital SSI . Additionally , only NNIS , pre-operative hospital stay , use of drains , and antibiotic prophylaxis were associated with postdischarge SSI . Conclusion Our study provided information on risk factors for SSI in a large population in general surgery setting in Italy . St and ardized postdischarge surveillance detected 38.6 % of all SSI . We also compared risk factors for in-hospital and postdischarge SSI , thus providing additional information to that of the current available literature . Finally , a large amount of postdischarge SSI were detected through telephone interview . The evaluation of the cost-effectiveness of the telephone interview as a postdischarge surveillance method could be an issue for further research BACKGROUND Previous studies have demonstrated higher infection rates following orthopaedic procedures on the foot and ankle as compared with procedures involving other areas of the body . Previous studies also have documented the difficulty of eliminating bacteria from the forefoot prior to surgery . The purpose of the present study was to evaluate the efficacy of three different surgical skin-preparation solutions in eliminating potential bacterial pathogens from the foot . METHODS A prospect i ve study was undertaken to evaluate 125 consecutive patients undergoing surgery of the foot and ankle . Each lower extremity was prepared with one of three r and omly selected solutions : DuraPrep ( 0.7 % iodine and 74 % isopropyl alcohol ) , Techni-Care ( 3.0 % chloroxylenol ) , or ChloraPrep ( 2 % chlorhexidine gluconate and 70 % isopropyl alcohol ) . After preparation , quantitative culture specimens were obtained from three locations : the hallux nailfold ( the hallux site ) , the web spaces between the second and third and between the fourth and fifth digits ( the toe site ) , and the anterior part of the tibia ( the control site ) . RESULTS In the Techni-Care group , bacteria grew on culture of specimens obtained from 95 % of the hallux sites , 98 % of the toe sites , and 35 % of the control sites . In the DuraPrep group , bacteria grew on culture of specimens obtained from 65 % of the hallux sites , 45 % of the toe sites , and 23 % of the control sites . In the ChloraPrep group , bacteria grew on culture of specimens from 30 % of the hallux sites , 23 % of the toe sites , and 10 % of the control sites . ChloraPrep was the most effective agent for eliminating bacteria from the halluces and the toes ( p < 0.0001 ) . CONCLUSIONS The use of effective preoperative preparation solution is an important step in limiting surgical wound contamination and preventing infection , particularly in foot and ankle surgery . Of the three solutions tested in the present study , the combination of chlorhexidine and alcohol ( ChloraPrep ) was most effective for eliminating bacteria from the forefoot prior to surgery ChloraPrep ( 2 % chlorhexidine gluconate + 70 % isopropyl alcohol [ CHG + IPA ] in a 3.0-mL applicator ) is a recently approved antiseptic for preoperative skin preparation . This controlled open-label trial assessed the immediate and persistent antimicrobial efficacy and safety of CHG + IPA compared with 70 % IPA or a 2 % CHG aqueous solution alone . Each antiseptic significantly reduced abdominal and inguinal microbial counts from baseline at 10 minutes , 6 hours , and 24 hours ( P = .0001 ) . CHG + IPA provided significantly more persistent antimicrobial activity on abdominal sites than IPA ( P = .003 ) or CHG ( P = .028 ) at 24 hours . No skin irritations were reported for any of the three antiseptics Purpose : There is limited work analyzing the efficacy of different antiseptics in reducing wound contamination by the skin flora during hernia repair and its influence on the incidence of wound infection , which continues to be a major problem in the developing world . This study was design ed to test if chlorhexidine-ethanol has superior antimicrobial efficacy compared with povidone-iodine . Methods : In a prospect i ve r and omized trial , the efficacy of chlorhexidine-ethanol and povidone-iodine in the reduction of colony counts of the skin flora and the incidence of surgical site infection was compared . Results : Both povidone-iodine and chlorhexidine-ethanol produced significant reduction in the skin bacterial colony counts , from 18.66 × 102 to 2.34 × 102 colony-forming units with povidone-iodine ( 59 % ) and from 12.34 × 102 to 0.93 × 102 colony-forming units ( 82 % ) with chlorhexidine-ethanol . Infection rates with the use of povidone-iodine and chlorhexidine-ethanol groups were not significantly different ( 9.5 vs. 7.0 ; p = 0.364 ) . The reduction in colony counts in those who developed infection was only 15.6 % compared with 77.1 % in those who did not develop infection . Conclusions : The antibacterial efficacy of chlorhexidine-ethanol and povidone-iodine is comparable in open hernia repair BACKGROUND Important characteristics for ideal skin preparations include long-lasting antimicrobial efficacy and low potential for skin irritation . METHODS A total of 55 healthy adult subjects were enrolled to evaluate the antimicrobial effects of 3 test formulations applied to inguinal , abdominal , and antecubital sites at post-treatment time points of 30 seconds , 72 hours , and 7 days . To investigate skin irritation potential , the 3 formulations were tested in a 21-day repeat-insult patch test conducted on the skin of the backs of 23 healthy subjects . RESULTS The mean log(10 ) reduction ( MLR ) at 7 days post-treatment produced by a 79 % vol/vol ethanol containing 1 % wt/vol chlorhexidine gluconate ( 1 % CHG-EtOH ) applied to abdominal sites was significantly superior to that produced by a 10 % povidone-iodine solution ( 2.45 MLR vs 0.90 MLR ; P < .05 ) . The 1 % CHG-EtOH and a 70 % vol/vol isopropanol containing 2 % wt/vol CHG ( 2 % CHG-IPA ) provided statistically equivalent persistence at 72 hours and 7 days post-treatment . The 1 % CHG-EtOH had less skin irritation potential than the 2 % CHG-IPA and the 10 % povidone-iodine solution , although the differences were not statistically significant ( P > .05 ) . CONCLUSION Considering its persistent effect and low skin irritation potential , the 1 % CHG-EtOH preparation is expected to perform well in surgical site preparation to reduce the risk of surgery- and catheter-related bloodstream infection OBJECTIVE To measure the impact of orthopedic surgical-site infections ( SSIs ) on quality of life , length of hospitalization , and cost . DESIGN A pairwise-matched ( 1:1 ) case-control study within a cohort . SETTING A tertiary-care university medical center and a community hospital . PATIENTS Cases of orthopedic SSIs were prospect ively identified by infection control professionals . Matched controls were selected from the entire cohort of patients undergoing orthopedic surgery who did not have an SSI . Matching variables included type of surgical procedure , National Nosocomial Infections Surveillance risk index , age , date of surgery , and surgeon . MAIN OUTCOME MEASURES Quality of life , duration of postoperative hospital stay , frequency of hospital readmission , overall direct medical costs , and mortality rate . RESULTS Fifty-nine SSIs were identified . Each orthopedic SSI accounted for a median of 1 extra day of stay during the initial hospitalization ( P = .001 ) and a median of 14 extra days of hospitalization during the follow-up period ( P = .0001 ) . Patients with SSI required more rehospitalizations ( median , 2 vs 1 ; P = .0001 ) and more total surgical procedures ( median , 2 vs 1 ; P = .0001 ) . The median total direct cost of hospitalizations per infected patient was $ 24,344 , compared with $ 6,636 per uninfected patient ( P = .0001 ) . Mortality rates were similar for cases and controls . Quality of life was adversely affected for patients with SSI . The largest decrements in scores on the Medical Outcome Study Short Form 36 question naire were seen in the physical functioning and role-physical domains . CONCLUSIONS Orthopedic SSIs prolong total hospital stays by a median of 2 weeks per patient , approximately double rehospitalization rates , and increase healthcare costs by more than 300 % . Moreover , patients with orthopedic SSIs have substantially greater physical limitations and significant reductions in their health-related quality of life Feet are prone to bacterial contamination . We hypothesized that chlorhexidine scrub and isopropyl alcohol paint provide superior local flora reduction than povidone-iodine scrub and paint . Patients with intact , uninfected skin having clean elective foot and ankle surgery were prospect ively enrolled and r and omly assigned to skin preparation with povidone-iodine ( Group 1 ) or chlorhexidine scrub and isopropyl alcohol paint ( Group 2 ) . Culture swabs ( aerobic , anaerobic , acid fast , fungus , and routine antibiotic sensitivity ) were taken from all web spaces , nail folds , toe surfaces , and proposed surgical incision sites . One-hundred twenty-seven patients were enrolled ( mean age , 46 years ; range , 16–85 years ) . Sixty-seven patients were assigned to Group 1 ; 60 patients were assigned to Group 2 . In Group 1 , 53 of 67 patients ( 79 % ) had positive cultures ; in Group 2 , 23 of 60 patients ( 38 % ) had positive cultures . These data indicate that chlorhexidine and alcohol provide better reduction in bacterial carriage than povidone-iodine . Based on these data , we recommended chlorhexidine as the surgical preparatory agent for the foot and ankle . Level of Evidence : Therapeutic study , Level I-1a ( significant difference ) . See the Guidelines for Authors for a complete description of levels of evidence PURPOSE We defined the relevant skin flora during genitourinary prosthetic surgery , evaluated the safety of chlorhexidine-alcohol for use on the male genitalia and compared chlorhexidine-alcohol to povidone-iodine in decreasing the rate of positive bacterial skin cultures at the surgical skin site before prosthetic device implantation . MATERIAL S AND METHODS In this single institution , prospect i ve , r and omized , controlled study we evaluated 100 consecutive patients undergoing initial genitourinary prosthetic implantation . Patients were r and omized to a st and ard skin preparation with povidone-iodine or chlorhexidine-alcohol . Skin cultures were obtained from the surgical site before and after skin preparation . RESULTS A total of 100 patients were r and omized , with 50 in each arm . Pre-preparation cultures were positive in 79 % of the patients . Post-preparation cultures were positive in 8 % in the chlorhexidine-alcohol group compared to 32 % in the povidone-iodine group ( p = 0.0091 ) . Coagulase-negative staphylococci were the most commonly isolated organisms in post-preparation cultures in the povidone-iodine group ( 13 of 16 patients ) as opposed to propionibacterium in the chlorhexidine-alcohol group ( 3 of 4 patients ) . Clinical complications requiring additional operations or device removal occurred in 6 patients ( 6 % ) with no significant difference between the 2 groups . No urethral or genital skin complications occurred in either group . CONCLUSIONS Chlorhexidine-alcohol was superior to povidone-iodine in eradicating skin flora at the surgical skin site before genitourinary prosthetic implantation . There does not appear to be any increased risk of urethral or genital skin irritation with the use of chlorhexidine compared to povidone-iodine . Chlorhexidine-alcohol appears to be the optimal agent for skin preparation before genitourinary prosthetic procedures BACKGROUND Surgical site infections ( SSI ) are an important source of morbidity and mortality . Chlorhexidine in isopropyl alcohol is effective in preventing central venous-catheter associated infections , but its effectiveness in reducing SSI in clean-contaminated procedures is uncertain . Surgical studies to date have had contradictory results . We aim ed to further evaluate the relationship of commonly used antiseptic agents and SSI , and to determine if isopropyl alcohol has a unique effect . STUDY DESIGN We performed a prospect i ve cohort analysis to evaluate the relationship of commonly used skin antiseptic agents and SSI for patients undergoing mostly clean-contaminated surgery from January 2011 through June 2012 . Multivariate regression modeling predicted expected rates of SSI . Risk adjusted event rates ( RAERs ) of SSI were compared across groups using proportionality testing . RESULTS Among 7,669 patients , the rate of SSI was 4.6 % . The RAERs were 0.85 ( p = 0.28 ) for chlorhexidine ( CHG ) , 1.10 ( p = 0.06 ) for chlorhexidine in isopropyl alcohol ( CHG+IPA ) , 0.98 ( p = 0.96 ) for povidone-iodine ( PVI ) , and 0.93 ( p = 0.51 ) for iodine-povacrylex in isopropyl alcohol ( IPC+IPA ) . The RAERs were 0.91 ( p = 0.39 ) for the non-IPA group and 1.10 ( p = 0.07 ) for the IPA group . Among elective colorectal patients , the RAERs were 0.90 ( p = 0.48 ) for CHG , 1.04 ( p = 0.67 ) for CHG+IPA , 1.04 ( p = 0.85 ) for PVI , and 1.00 ( p = 0.99 ) for IPC+IPA . CONCLUSIONS For clean-contaminated surgical cases , this large-scale state cohort study did not demonstrate superiority of any commonly used skin antiseptic agent in reducing the risk of SSI , nor did it find any unique effect of isopropyl alcohol . These results do not support the use of more expensive skin preparation agents OBJECTIVE To compare the effects of different skin preparation solutions on surgical-site infection rates . DESIGN Three skin preparations were compared by means of a sequential implementation design . Each agent was adopted as the preferred modality for a 6-month period for all general surgery cases . Period 1 used a povidone-iodine scrub-paint combination ( Betadine ) with an isopropyl alcohol application between these steps , period 2 used 2 % chlorhexidine and 70 % isopropyl alcohol ( ChloraPrep ) , and period 3 used iodine povacrylex in isopropyl alcohol ( DuraPrep ) . Surgical-site infections were tracked for 30 days as part of ongoing data collection for the National Surgical Quality Improvement Project initiative . The primary outcome was the overall rate of surgical-site infection by 6-month period performed in an intent-to-treat manner . SETTING Single large academic medical center . PATIENTS All adult general surgery patients . RESULTS The study comprised 3,209 operations . The lowest infection rate was seen in period 3 , with iodine povacrylex in isopropyl alcohol as the preferred preparation method ( 3.9 % , compared with 6.4 % for period 1 and 7.1 % for period 2 ; P = .002 ) . In subgroup analysis , no difference in outcomes was seen between patients prepared with povidone-iodine scrub-paint and those prepared with iodine povacrylex in isopropyl alcohol , but patients in both these groups had significantly lower surgical-site infection rates , compared with rates for patients prepared with 2 % chlorhexidine and 70 % isopropyl alcohol ( 4.8 % vs 8.2 % ; P = .001 ) . CONCLUSIONS Skin preparation solution is an important factor in the prevention of surgical-site infections . Iodophor-based compounds may be superior to chlorhexidine for this purpose in general surgery patients Background : Currently a lack of consensus exists on the optimum solution and preparation methods needed to decrease bacteria present during forefoot surgery . We therefore compared the effect of povidine-iodine and chlorhexidine gluconate on lowering bacterial load and to study any additional benefits gained by pre-treatment with the use of a bristled brush . Material s and Methods : Fifty consecutive patients undergoing forefoot surgery were recruited into the study and r and omized to receive one of two surgical skin preparations ( Povidine-iodine 1 % with isopropyl alcohol 23 % or Chlorhexidine gluconate 0.5 % with isopropyl alcohol 70 % ) . In addition to the skin preparation of the foot with the r and omized solution , the subjects other foot was also scrubbed with a sterile surgical bristled brush for three minutes and then painted with the same solution . Swabs were taken from three sites and analyzed via qualitative and quantitative analysis before and after prepping . Results : All four preparation methods significantly decreased ( p < 0.001 ) , in all three sites , the number of colony forming units . Using two-way analysis of variance , no significant interaction was observed between preparation method and number of colony-forming units , suggesting that no difference in bacterial inhibition between preparation methods . Conclusion : We suggest that either povidone - iodine with no more that 23 % isopropyl alcohol or chlorhexidine gluconate with 70 % isopropyl alcohol be used for surgical preparation in forefoot surgery . No additional benefit in reduction in bacterial load was gained by scrubbing the foot with bristles prior to painting |
1,301 | 17,610,809 | Two cohort studies considering atrial natriuretic peptide and two considering brain ( B-type ) natriuretic peptide suggested that these chemicals are elevated in some subgroups of children treated with anthracyclines for cancer .
This will have an impact on cardiac services and costs . | OBJECTIVES To evaluate the technologies used to reduce anthracycline-induced cardiotoxicity in children .
Also to evaluate cardiac markers to quantify cardiotoxicity , and identify cost-effectiveness studies and future research priorities . | PURPOSE We conducted an open-label , r and omized trial to determine whether ICRF-187 would reduce doxorubicin-induced cardiotoxicity in pediatric sarcoma patients . METHODS Thirty-eight patients were r and omized to receive doxorubicin-containing chemotherapy ( given as an intravenous bolus ) with or without ICRF-187 . Resting left ventricular ejection fraction ( LVEF ) was monitored serially with multigated radionuclide angiography ( MUGA ) scan . The two groups were compared for incidence and degree of cardiotoxicity , response rates to four cycles of chemotherapy , event-free and overall survival , and incidence and severity of noncardiac toxicities . RESULTS Eighteen ICRF-187-treated and 15 control patients were assessable for cardiac toxicity . ICRF-187-treated patients were less likely to develop sub clinical cardiotoxicity ( 22 % v 67 % , P < .01 ) , had a smaller decline in LVEF per 100 mg/m2 of doxorubicin ( 1.0 v 2.7 percentage points , P = .02 ) , and received a higher median cumulative dose of doxorubicin ( 410 v 310 mg/m2 , P < .05 ) than did control patients . Objective response rates were identical in the two groups , with no significant differences seen in event-free or overall survival . ICRF-187-treated patients had a significantly higher incidence of transient grade 1 serum transaminase elevations and a trend toward increased hematologic toxicity . CONCLUSION ICRF-187 reduces the risk of developing short-term sub clinical cardiotoxicity in pediatric sarcoma patients who receive up to 410 mg/m2 of doxorubicin . Response rates to chemotherapy , event-free and overall survival , and noncardiac toxicities appear to be unaffected by the use of ICRF-187 . Additional clinical trials with larger numbers of patients are needed to determine if the short-term cardioprotection afforded by ICRF-187 will reduce the incidence of late cardiac complications in long-term survivors of childhood cancer Anthracyclines are a group of drugs that are useful in the treatment of Hodgkin 's disease , but have been associated with severe , and in some cases lethal , cardiac toxicity . Apparently , cardiac toxicity is more frequent after 10 years of anthracycline therapy , but no longer studies of cardiac toxicity have been reported . Four hundred and seventy-six patients with Hodgkin 's disease , stages III and IV , were r and omly assigned to receive ABVD ( doxorubicin , bleomycin , vinblastine and dacarbazine ) compared with EBVD ( epirubicin instead of doxorubicin ) and MBVD ( mitoxantrone instead of doxorubicin ) at st and ard doses . The endpoint was the presence of a clinical cardiac event ( CCE ) or abnormalities in equilibrium radionuclide angiocardiography ( ERNA ) and echocardiogram . The patients did not receive radiation therapy and when relapsed they were censored from cardiac toxicity . The median follow-up was 11.5 years ( range 7.5 - 14.8 years ) . CCE was observed in 17 % in the MBVD arm , 9 % in the ABVD arm and 6 % in the EBVD arm ( P < 0.001 ) . Mortality associated with CCE was 12 % with MBVD , 7 % with ABVD and 2 % with EBVD . Abnormalities in ERNA and echocardiogram were observed 6 - 36 months before the presence of a CCE . An excess in the st and ard mortality ratio was observed with the 3 regimens when compared with the general population : 19.4 for EBVD , 46.0 for ABVD and 67.8 for MBVD , which was confirmed with an increase in absolute excess risk/10,000 person-years of 15.6 , 39.0 and 58.7 , respectively . Overall survival was better in patients treated with EBVD because less cardiac events were observed . The use of mitoxantrone was associated with a high rate of relapse and cardiac events . Thus , we would not recommend use of the drug in Hodgkin 's disease . ERNA and echocardiogram are early detection tests for cardiac toxicity and can be employed in surveillance studies BACKGROUND Doxorubicin chemotherapy is very effective in children with acute lymphoblastic leukemia ( ALL ) but also injures myocardial cells . Dexrazoxane , a free-radical scavenger , may protect the heart from doxorubicin-associated damage . METHODS To determine whether dexrazoxane decreases doxorubicin-associated injury of cardiomyocytes , we r and omly assigned 101 children with ALL to receive doxorubicin alone ( 30 mg per square meter of body-surface area every three weeks for 10 doses ) and 105 to receive dexrazoxane ( 300 mg per square meter ) followed immediately by doxorubicin . Serial measurements of serum cardiac troponin T were obtained in 76 of 101 patients in the doxorubicin group and 82 of 105 patients in the group given dexrazoxane and doxorubicin . A total of 2377 serum sample s ( mean , 15.1 sample s per patient ) were obtained before , during , and after treatment with doxorubicin . Troponin T levels were evaluated in a blinded fashion to determine whether they were elevated ( > 0.01 ng per milliliter)--the primary end point -- or extremely elevated ( > 0.025 ng per milliliter ) . RESULTS Elevations of troponin T occurred in 35 percent of the patients ( 55 of 158 ) . Patients treated with doxorubicin alone were more likely than those who received dexrazoxane and doxorubicin to have elevated troponin T levels ( 50 percent vs. 21 percent , P<0.001 ) and extremely elevated troponin T levels ( 32 percent vs. 10 percent , P<0.001 ) . The median follow-up was 2.7 years . The rate of event-free survival at 2.5 years was 83 percent in both groups ( P=0.87 by the log-rank test ) . CONCLUSIONS Dexrazoxane prevents or reduces cardiac injury , as reflected by elevations in troponin T , that is associated with the use of doxorubicin for childhood ALL without compromising the antileukemic efficacy of doxorubicin . Longer follow-up will be necessary to determine the influence of dexrazoxane on echocardiographic findings at four years and on event-free survival Doxorubicin has been used in the the treatment of malignant tumors in children . Its use is limited by cardiotoxic effects beyond a cumulative dose of 450 mg/m2 . To detect cardiotoxicity at an early stage and identify patients at risk for development of cardiotoxicity are matters of concern . Recently , cardiac troponin I ( cTnI ) has been reported to be useful for detecting minor myocardial damage . In the present study , we investigated whether cumulative doxorubicin-related myocardial cell damage can potentially increase cTnI levels above the expected values in 22 patients treated with cumulative doxorubicin doses of 120 to 450 mg/m2 . Impaired cardiac functions were found in three patients by echocardiography , but serum CTnI levels were within the ranges expected in healthy individuals both in patients with cumulative doxorubicin doses > or = 400 mg/m2 and in patients with disturbed cardiac functions . We found no relationship between serum cTnI , cumulative dose of doxorubicin , and echocardiographical findings Two hundred fourteen eligible patients with previously untreated , localized Ewing 's sarcoma of bone were r and omized on IESS-II to receive Adriamycin ( ADR ; doxorubicin ; Adria Laboratories , Columbus , OH ) , cyclophosphamide , vincristine , and dactinomycin by either a high-dose intermittent method ( treatment [ trt ] 1 ) or a moderate-dose continuous method ( trt 2 ) similar to the four-drug arm of IESS-I. Patient characteristics ( sex , primary site , type of surgery ) were stratified at the time of registration ; these and other patient characteristics ( age , time from symptoms to diagnosis , race ) were distributed similarly between treatments . Surgical resection was encouraged , but not m and atory . Local radiation therapy was the same as for IESS-I. The median follow-up time is 5.6 years . The overall outcome was significantly better on trt 1 than on trt 2 . At 5 years , the estimated percentages of patients who were disease-free , relapse-free , and surviving were 68 % , 73 % , and 77 % for trt 1 and 48 % , 56 % , and 63 % for trt 2 ( P = .02 , .03 , and .05 , respectively ) . The major reason for treatment failure for both treatment groups was the development of metastatic disease . The lung was the most common site of metastases followed by bone sites . The combined incidence of severe or worse toxicity ( 67 % ) was comparable between the treatments ; however , severe or worse cardiovascular toxicity was significantly greater on trt 1 . Tne only treatment-associated deaths ( N = 3 ) were on trt 1 and were cardiac-related The objective of this study is to assess the efficacy of ICRF-187 as a protective agent against anthracycline cardiotoxicity . Cardiac function was evaluated by echocardiography before and after each cycle of anthracycline chemotherapy associated with ICRF-187 and compared with that of a second group receiving anthracycline chemotherapy without ICRF-187 . The patients were a group of 15 consecutive children affected with various types of solid tumors who were treated with either doxorubicin-daunomycin or epirubicin ( average doses 340 and 280 mg/m2 , respectively ) , and treatment was associated with ICRF-187 . A second group of 15 consecutive children affected with different malignancies were simultaneously treated with either doxorubicin-daunomycin or epirubicin ( average doses 309 and 270 mg/m2 , respectively ) , but without ICRF-187 association . None of the patients treated with anthracyclines and ICRF-187 association showed abnormalities on echocardiographic examination . In the second group of patients treated with anthracyclines but without ICRF-187 association , we observed a decrease in the left ventricular ejection fraction to < 55 % and a decrease in the left ventricular fractional shortening to < 28 % in two patients ( 13.3 % ) . One of these ( 6.6 % ) showed a dilatative cardiomyopathy . Both groups of patients were treated with low doses of anthracyclines . Although this study was not r and omized , in patients without ICRF-87 cardioprotection , there was a trend for a worse evolution with one case of clinical cardiomyopathy as well as sub clinical cardiac abnormalities Doxorubicin is one of the most effective anticancer drug , but its usefulness is limited by the risk of developing cardiomyopathy , cardiac dysfunction and ventricular arrhythmias . Dexrazoxane is used to protect against doxorubicin cardiotoxicity . It is uncertain whether the dexrazoxane-mediated cardioprotective effect will be reflected in electrophysiological properties of the heart . The aim of the present study was to evaluate the occurrence of frequency-domain signal-averaged electrocardiographic ( SAECG ) abnormalities of the QRS complex and the initial ST segment in patients treated with and without dexrazoxane . Thirty children and young adults 2 months - 15 years after completion of doxorubicin-containing therapy for Hodgkin 's disease were evaluated with SAECG . Patients from group I ( n = 13 ) received combined therapy with doxorubicin and dexrazoxane ( DOX/DZX ) , patients from group II ( n = 17 ) received doxorubicin without dexrazoxane ( DOX ) . Using fast Fourier transformation within the QRS complex and the initial ST segment , area ratio ( AR ) values 40 - 100/0 - 40 Hz were calculated . Significant differences in these frequency parameters in the QRS complex between DOX/DZX group and DOX group ( 19.45+/-12.72 vs 46.18+/-43.06 ; p = 0.03 ) might indicate protective effect of dexrazoxane on electrophysiological myocardial properties Doxorubicin is an anthracycline antibiotic with a broad spectrum of antineoplastic activity . Cardiotoxicity is a serious long-term complication of the drug . Simultaneous administration of carnitine has been proposed to prevent cardiotoxicity . We aim ed to monitor the serum carnitine levels during the treatment of doxorubicin and to determine a relationship between serum carnitine levels and cardiac dysfunction . Fifteen patients were evaluated prospect ively . Measurement of carnitine levels and evaluation of cardiac function were performed prior to treatment , and after cumulative doses of 180 and 300 mg/m2 of doxorubicin . A group of 20 healthy children served as control group to obtain reference values . We found sub clinical abnormalities in cardiac function , while the cumulative doses of the doxorubicin was increasing . The mean end diastolic and end systolic left ventricular dimensions of the patient group after completion of the treatment were significantly increased compared with initial values . The ejection and shortening fraction of the patient group after cumulative doses of 300 mg/m2 of doxorubicin were significantly lower than those of the control group . A statistically significant augmentation was observed in mitral A , with a decrease in mitral E/A ratio . There was a trend towards lower serum carnitine levels with higher cumulative doses of doxorubicin , although it was not statistically significant . Our results invite new detailed investigations depending on the measurement of serum and urinary free and acyl carnitine and myocardial carnitine levels to evaluate possible roles of carnitine in the prevention of doxorubicin-induced cardiotoxicity OBJECTIVE --A pilot study to assess the efficacy of ICRF187 as a protective agent against the cardiotoxic effects of anthracycline drugs used to treat childhood malignancies . DESIGN --A study of cardiac function in children treated receiving ICRF187 ( (s)-(+)-1,2 bis ( 3,5-dioxopiperazenyl ) propane ) in addition to anthracycline therapy compared with contemporary controls selected retrospectively on the basis of anthracycline dose matching . PATIENTS --Five children in whom recurrence of malignant disease was re-treated with chemotherapy containing anthracycline drugs and additional ICRF187 ( supplied on a compassionate-use basis ) ( cumulative anthracycline doses 550 - 1650 mg/m2 ) . Five more children with recurrence of malignant disease were re-treated to similar cumulative anthracycline doses ( 600 - 1150 mg/m2 ) without ICRF187 . METHODS --Cardiac function was assessed clinical ly and echocardiographically throughout treatment . Clinical and echocardiographic state were compared before treatment and after completion of therapy within and between groups treated with and without ICRF187 . RESULTS --Two patients treated without ICRF187 developed symptomatic congestive cardiac failure from which one died . Another developed considerable but as yet asymptomatic left ventricular dysfunction . No patient receiving additional ICRF187 developed cardiac failure or left ventricular dysfunction . There were no significant differences in cumulative anthracycline dose , dose increase , type of anthracycline used , survival rate , or length of survival between groups . Left ventricular shortening fraction fell by a mean of 1.0 % in patients receiving ICRF187 and by a mean of 11 % in the patients treated without it ( p = 0.04 ) . CONCLUSIONS --ICRF187 seems to have provided highly effective cardioprotection to this small group of children with end-stage malignancy . Severe cardiotoxicity was seen in a similar group treated with comparable anthracycline doses but without ICRF187 The severity of late cardiotoxicity after anthracycline treatment for childhood cancer relates mainly to the cumulative anthracycline dose received , but all dose ranges cause some cardiac dysfunction . Anthracycline administration by infusion in order to lower peak drug concentration has been used in an attempt to reduce cardiotoxicity . Cardiac performance was assessed by echocardiography in children who were relapse‐free survivors of treatment for acute lymphoblastic leukaemia ( ALL ) . They received the same cumulative anthracycline dose ( daunorubicin 180 mg/m2 ) either by bolus injection ( UKALL X protocol , n = 40 ) or by infusion ( UKALL XI protocol , n = 71 ) with a follow‐up duration of 5·3 ± 2·0 and 5·4 ± 1·0 years respectively . On analysis , both the bolus administration and infusion groups showed similar mild impairment of cardiac performance , characterized by increased left ventricular end systolic stress and impaired left ventricular function . In conclusion , sub clinical abnormality of left ventricular performance was confirmed in both groups despite the relatively modest cumulative anthracycline dose received . We were unable to demonstrate an advantage of anthracycline administration by 6‐h infusion with respect to late cardiotoxicity at this dose |
1,302 | 27,026,510 | The results show that it may not be safe to use a restrictive transfusion threshold of less than 80 g/L in patients with ongoing acute coronary syndrome or chronic cardiovascular disease .
Effects on mortality and other outcomes are uncertain . | OBJECTIVE To compare patient outcomes of restrictive versus liberal blood transfusion strategies in patients with cardiovascular disease not undergoing cardiac surgery . | BACKGROUND Perioperative anemia leads to increased morbidity and mortality and potentially inhibits rehabilitation after hip fracture surgery . As such , the optimum transfusion threshold after hip fracture surgery is unknown . PATIENTS AND METHODS A total of 120 elderly , cognitively intact hip fracture patients admitted from their own home were r and omly assigned to receive transfusion at a hemoglobin threshold of 10.0 g per dL ( liberal ) versus 8.0 g per dL ( restrictive ) in the entire perioperative period . Patients were treated according to a well-defined multimodal rehabilitation program . Primary outcome was postoperative functional mobility measured with the cumulated ambulation score ( CAS ) . RESULTS Patients in the liberal group received transfusions more frequently than those in the restrictive group ( 44 patients vs. 22 patients ; p < 0.01 ) and received more transfusions during hospitalization ( median , 2 units [ interquartile range , 1 - 2 ] vs. 1 [ 1 - 2 ] ; p < 0.0001 ) . There were no significant differences in postoperative rehabilitation scores ( CAS : median , 9 [ 9 - 15 ] vs. 9 [ 9 - 13.5 ] ; p = 0.46 ) or in length of stay ( median , 18 days vs. 16 days , respectively ; p = 0.46 ) . There were fewer patients in the liberal transfusion group with cardiovascular complications ( 2 % vs. 10 % ; p = 0.05 ) and a lower mortality ( 0 % vs. 8 % ; p = 0.02 ) . CONCLUSION Although a liberal transfusion trigger did not result in increased ambulation scores , restrictive transfusion thresholds should be treated with caution in elderly high-risk hip fracture patients , until their safety has been proved in larger r and omized studies BACKGROUND AND OBJECTIVES Red cell transfusion is commonly used in orthopaedic surgery . Evidence suggests that a restrictive transfusion strategy may be safe for most patients . However , concern has been raised over the risks of anaemia in those with ischaemic cardiac disease . Perioperative silent myocardial ischaemia ( SMI ) has a relatively high incidence in the elderly population undergoing elective surgery . This study used Holter monitoring to compare the effect of a restrictive and a liberal red cell transfusion strategy on the incidence of SMI in patients without signs or symptoms of ischaemic heart disease who were undergoing lower limb arthroplasty . MATERIAL S AND METHODS We performed a multicentre , controlled trial in which 260 patients undergoing elective hip and knee replacement surgery were enrolled and r and omized to transfusion triggers that were either restrictive ( 8 g/dl ) or liberal ( 10 g/dl ) . Participants were monitored with continuous ambulatory electrocardiogram ( ECG ) ( Holter monitoring ) , preoperatively for 12 h and postoperatively for 72 h. The tapes were analysed for new ischaemia by technicians blinded to treatment . The total ischaemia time in minutes was divided by the recording time in hours and an ischaemic load in min/h was calculated . Haemoglobin levels were measured preoperatively , postoperatively in the recovery room , and on days one , three and five after surgery . RESULTS The mean postoperative haemoglobin concentration was 9.87 g/dl in the restrictive group and 11.09 g/dl in the liberal group . In the restrictive group , 34 % were transfused a total of 89 red cell units , and in the liberal group 43 % were given a total of 119 red cell units . A postoperative episode of silent ischaemia was experienced by 21/109 ( 19 % ) patients in the restrictive group and by 26/109 ( 24 % ) patients in the liberal group [ mean difference -4.6 % ; 95 % confidence interval ( CI ) : -15.5 % to 6 % , P = 0.41 ) . There was no significant difference ( P = 0.53 ) between the overall ischaemic load in the restrictive group ( median 0 min/h , range 0 - 4.18 ) and the liberal group ( median 0 min/h , range 0 - 19.48 ) . In those patients who did experience postoperative SMI , the mean ischaemic load was 0.48 min/h in the restrictive group and 1.51 min/h in the liberal group ( ratio 0.32 , 95 % CI : 0.14 - 0.76 , P = 0.011 ) . The median postoperative length of hospital stay in the restrictive group was 7.3 days [ range 5 - 11 ; interquartile range ( IQR ) 6 - 8 ] compared with 7.5 days ( range 5 - 13 ; IQR 7 - 8 ) in the liberal group . The numbers were not large enough to conclude equivalence . CONCLUSIONS In patients without preoperative evidence of myocardial ischaemia undergoing elective hip and knee replacement surgery , a restrictive transfusion strategy seems unlikely to be associated with an increased incidence of SMI . A proportion of these patients experience moderate SMI , regardless of the transfusion trigger . Use of a restrictive transfusion strategy did not increase length of hospital stay , and use of this strategy would lead to a significant reduction in red cell transfusion in orthopaedic surgery . Our data did not indicate any potential for harm in employing such a strategy in patients with no prior evidence of cardiac ischaemia who were undergoing elective orthopaedic surgery Objective To evaluate the immediate effects of red blood cell transfusion on central venous oxygen saturation and lactate levels in septic shock patients with different transfusion triggers . Methods We included patients with a diagnosis of septic shock within the last 48 hours and hemoglobin levels below 9.0g/dL Patients were r and omized for immediate transfusion with hemoglobin concentrations maintained above 9.0g/dL ( Group Hb9 ) or to withhold transfusion unless hemoglobin felt bellow 7.0g/dL ( Group Hb7 ) . Hemoglobin , lactate , central venous oxygen saturation levels were determined before and one hour after each transfusion . Results We included 46 patients and 74 transfusions . Patients in Group Hb7 had a significant reduction in median lactate from 2.44 ( 2.00 - 3.22 ) mMol/L to 2.21 ( 1.80 - 2.79 ) mMol/L , p = 0.005 , which was not observed in Group Hb9 [ 1.90 ( 1.80 - 2.65 ) mMol/L to 2.00 ( 1.70 - 2.41 ) mMol/L , p = 0.23 ] . Central venous oxygen saturation levels increased in Group Hb7 [ 68.0 ( 64.0 - 72.0)% to 72.0 ( 69.0 - 75.0)% , p < 0.0001 ] but not in Group Hb9 [ 72.0 ( 69.0 - 74.0)% to 72.0 ( 71.0 - 73.0)% , p = 0.98 ] . Patients with elevated lactate or central venous oxygen saturation < 70 % at baseline had a significant increase in these variables , regardless of baseline hemoglobin levels . Patients with normal values did not show a decrease in either group . Conclusion Red blood cell transfusion increased central venous oxygen saturation and decreased lactate levels in patients with hypoperfusion regardless of their baseline hemoglobin levels . Transfusion did not appear to impair these variables in patients without hypoperfusion . Clinical Trials.gov OBJECTIVE In elective orthopaedic hip- and knee replacement surgery patients , we studied the effect of implementation of a uniform transfusion policy on RBC usage . STUDY DESIGN AND METHODS A r and omized , controlled study . A new uniform , restrictive transfusion policy was compared with st and ard care , which varied among the three participating hospitals . Only prestorage leucocyte-depleted RBC(s ) were used . Primary end-point was RBC usage , related to length of hospital stay . Secondary end-points were Hb levels , mobilization delay and postoperative complications . RESULTS Six hundred and three patients were evaluated . Adherence to the protocol was over 95 % . Overall mean RBC usage was 0.78 U/patient in the new policy group and 0.86 U/patient in the st and ard care policy group ( mean difference 0.08;95 % CI [ -0.3 ; 0.2 ] ; P = 0.53 ) . In two hospitals , the new transfusion policy result ed in a RBC reduction of 30 % ( 0.58U RBC/patient ) ( P = 0.17 ) and 41 % ( 0.29 U RBC/patient ) ( P = 0.05 ) respectively . In the third hospital , however , RBC usage increased by 39 % ( 0.31 U RBC/patient ) ( P = 0.02 ) with the new policy , due to a more restrictive st and ard care policy in that hospital . Length of hospital stay was not influenced by either policy . CONCLUSIONS Implementation of a uniform transfusion protocol for elective lower joint arthroplasty patients is feasible , but does not always lead to a RBC reduction . Length of hospital stay was not affected Background : Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients , but there is no clear evidence to support the superiority of any perioperative transfusion strategy in patients with cancer . Methods : In a r and omized , controlled , parallel-group , double-blind ( patients and outcome assessors ) superiority trial in the intensive care unit of a tertiary oncology hospital , the authors evaluated whether a restrictive strategy of erythrocyte transfusion ( transfusion when hemoglobin concentration < 7 g/dl ) was superior to a liberal one ( transfusion when hemoglobin concentration < 9 g/dl ) for reducing mortality and severe clinical complications among patients having major cancer surgery . All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and r and omly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy . The primary outcome was a composite endpoint of mortality and morbidity . Results : A total of 198 patients were included as follows : 101 in the restrictive group and 97 in the liberal group . The primary composite endpoint occurred in 19.6 % ( 95 % CI , 12.9 to 28.6 % ) of patients in the liberal- strategy group and in 35.6 % ( 27.0 to 45.4 % ) of patients in the restrictive- strategy group ( P = 0.012 ) . Compared with the restrictive strategy , the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16 % ( 3.8 to 28.2 % ) and a number needed to treat of 6.2 ( 3.5 to 26.5 ) . Conclusion : A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy Background : Due to the floating of the guideline , there is no evidence -based evaluation index on when to start the blood transfusion for patients with hemoglobin ( Hb ) level between 7 and 10 g/dl . As a result , the trigger point of blood transfusion may be different in the emergency use of the existing transfusion guidelines . The present study was design ed to evaluate whether the scheme can be safely and effectively used for emergency patients , so as to be supported by multicenter and large sample data in the future . Methods : From June 2013 to June 2014 , patients were r and omly divided into the experimental group ( Peri-operative Transfusion Trigger Score of Emergency [ POTTS-E ] group ) and the control group ( control group ) . The between-group differences in the patients ’ demography and baseline information , mortality and blood transfusion-related complications , heart rate , resting arterial pressure , body temperature , and Hb values were compared . The consistency of red blood cell ( RBC ) transfusion st and ards of the two groups of patients with the current blood transfusion guideline , namely the compliance of the guidelines , utilization rate , and per-capita consumption of autologous RBC were analyzed . Results : During the study period , a total of 72 patients were recorded , and 65 of them met the inclusion criteria , which included 33 males and 32 females with a mean age of ( 34.8 ± 14.6 ) years . 50 underwent abdomen surgery , 4 underwent chest surgery , 11 underwent arms and legs surgery . There was no statistical difference between the two groups for demography and baseline information . There was also no statistical differences between the two groups in anesthesia time , intraoperative rehydration , staying time in postanesthetic care unit , emergency hospitalization , postoperative 72 h Acute Physiologic Assessment and Chronic Health Evaluation II scores , blood transfusion-related complications and mortality . Only the POTTS-E group on the 1st postoperative day Hb was lower than group control , P < 0.05 . POTTS-E group was totally ( 100 % ) conformed to the requirements of the transfusion guideline to RBC infusion , which was higher than that of the control group ( 81.25 % ) , P < 0.01 . There were no statistical differences in utilization rates of autologous blood of the two groups ; the utilization rates of allogeneic RBC , total allogeneic RBC and total RBC were 48.48 % , 51.5 % , and 75.7 % in POTTS-E group , which were lower than those of the control group ( 84.3 % , 84.3 % , and 96.8 % ) P < 0.05 or P < 0.01 . Per capita consumption of intraoperative allogeneic RBC , total allogeneic RBC and total RBC were 0 ( 0 , 3.0 ) , 2.0 ( 0 , 4.0 ) , and 3.1 ( 0.81 , 6.0 ) in POTTS-E groups were all lower than those of control group ( 4.0 [ 2.0 , 4.0 ] , 4.0 [ 2.0 , 6.0 ] and 5.8 [ 2.7 , 8.2 ] ) , P < 0.05 or P < 0.001 . Conclusions : Peri-operative Transfusion Trigger Score-E evaluation scheme is used to guide the application of RBC . There are no differences in the recent prognosis of patients with the traditional transfusion guidelines . This scheme is safe ; Compared with doctor experience-based subjective assessment , the scoring scheme was closer to patient physiological needs for transfusion and more reasonable ; Utilization rate and the per capita consumption of RBC are obviously declined , which has clinical significance and is feasible . Based on the abovementioned three points , POTTS-E scores scheme is safe , reasonable , and practicable and has the value for carrying out multicenter and large sample clinical research es Background and purpose — Hip fracture ( HF ) in frail elderly patients is associated with poor physical recovery and death . There is often postoperative blood loss and the hemoglobin ( Hb ) threshold for red blood cell ( RBC ) transfusions in these patients is unknown . We investigated whether RBC transfusion strategies were associated with the degree of physical recovery or with reduced mortality after HF surgery . Patients and methods — We enrolled 284 consecutive post-surgical HF patients ( aged ≥ 65 years ) with Hb levels < 11.3 g/dL ( 7 mmol/L ) who had been admitted from nursing homes or sheltered housing . Allocation was stratified by residence . The patients were r and omly assigned to either restrictive ( Hb < 9.7 g/dL ; < 6 mmol/L ) or liberal ( Hb < 11.3 g/dL ; < 7 mmol/L ) RBC transfusions given within the first 30 days postoperatively . Follow-up was at 90 days . Results — No statistically significant differences were found in repeated measures of daily living activities or in 90-day mortality rate between the restrictive group ( where 27 % died ) and the liberal group ( where 21 % died ) . Per- protocol 30-day mortality was higher with the restrictive strategy ( hazard ratio ( HR ) = 2.4 , 95 % CI : 1.1–5.2 ; p = 0.03 ) . The 90-day mortality rate was higher for nursing home residents in the restrictive transfusion group ( 36 % ) than for those in the liberal group ( 20 % ) ( HR = 2.0 , 95 % CI : 1.1–3.6 ; p = 0.01 ) . Interpretation — According to our Hb thresholds , recovery from physical disabilities in frail elderly hip fracture patients was similar after a restrictive RBC transfusion strategy and after a liberal strategy . Implementation of a liberal RBC transfusion strategy in nursing home residents has the potential to increase survival Objectives It is still under debate that red blood cell ( RBC ) transfusions might increase the risk of healthcare-associated infections after hip fracture surgery . Previously , we found that a liberal RBC transfusion strategy improved survival in nursing home residents . Our aim , therefore , was to investigate whether a more liberal RBC transfusion strategy was associated with a higher infection risk in frail elderly hip fracture patients . Design Prospect i ve , assessor-blinded , r and omized and controlled trial . Setting sOrthopedic ward , Geriatric ward , and Hospital-at-home . Patients 284 consecutively hospital-admitted elderly with hip fracture from nursing homes or sheltered housing facilities were included . InterventionA restrictive RBC transfusion strategy ( hemoglobin < 9.7 g/dL ; 6 mmol/L ) compared with a liberal strategy ( hemoglobin < 11.3 g/dL ; 7 mmol/L ) administered within 30 days after surgery . Main outcome measurements Leukocytes and C-reactive protein ( CRP ) in repeated blood sample s within 30 days , and number of all infections ( pneumonia , urinary tract infection , and other infections ) within 10 days . Results 88 % of the patients received a RBC transfusion . A median of 1 RBC unit ( interquartile range ( IQR ) : 1–2 ) was transfused for the restrictive strategy group versus 3 RBC units ( IQR : 2–5 ) for the liberal group . Leukocytes and CRP measurements were similar for both groups . Rates of infection were 72 % for the restrictive group compared to 66 % for the liberal group ( risk ratio 1.08 ; 95 % confidence interval 0.93–1.27 , p value 0.29 ) . Conclusions A more liberal RBC transfusion strategy was not associated with higher risk of infection among residents from nursing homes or sheltered housing undergoing hip fracture surgery BACKGROUND Patients undergoing major arterial reconstruction have traditionally been transfused with red blood cells to keep hemoglobin concentrations above 10 g/dL in order to prevent anemia-induced myocardial ischemia . There are no data to support this practice . The hypothesis that vascular patients will tolerate a hemoglobin concentration of 9 g/dL was examined . METHODS Ninety-nine patients undergoing elective aortic and infrainguinal arterial reconstructions were prospect ively r and omized preoperatively to receive transfusions to maintain a hemoglobin level of either 10 g/dL or 9 g/dL. RESULTS Despite significantly different postoperative hemoglobin levels of 11.0 + /- 1.2 versus 9.8 + /- 1.3 g/dL ( P < 0.0001 ) , there were no differences in mortality or cardiac morbidity rates or length of hospital stay . There were no differences in hemodynamic parameters . Oxygen delivery was lower in the group with lower hemoglobin levels , but there was no difference in O2 consumption between the groups . CONCLUSIONS A lower hemoglobin concentration was tolerated without adverse clinical outcome . Patients did not compensate for anemia by increased myocardial work , but by increasing O2 extraction in the peripheral tissues Purpose To evaluate if raising baseline and maintaining hemoglobin ( Hb ) levels with red blood cell ( RBC ) transfusion could improve the outcomes of chemotherapy for advanced gastric cancer ( AGC ) . Methods Patients were r and omized to receive RBC transfusion to maintain their Hb levels ≥10 g/dl ( arm 1 ) or ≥12 ( arm 2 ) before the start of their 5-fluorouracil-based first-line chemotherapy . Objective response , KPS and quality of life ( QOL ) data were measured . Results For 87 patients enrolled , mean baseline Hb was 10.1 g/dl , and 54 patients received RBC prior to chemotherapy initiation . Despite transfusion , we failed to maintain the Hb level above the predefined target range . Eighteen patients experienced brief and reversible adverse events during transfusion , including two patients with acute pulmonary edema . KPS was improved from baseline to post-chemotherapy in both arms . QOL data showed improvement in some symptom scores , but there was no difference in the QOL scores between the two arms at baseline and all four cycles of treatment . Similar response rates were observed in both arms ( arm 1 , 30 % ; arm 2 , 35 % ) . Both arms showed similar chemotherapy duration ( 3.8 and 4.1 months , respectively ) , progression-free survival ( 4.0 and 4.1 months ) and overall survival ( 9.9 and 9.3 months ) . Conclusions Red blood cell transfusion achieving Hb level above 10 g/dl might contribute to the improvement of the KPS and QOL seen in patients with AGC . The observation of equivalent outcomes at the two target Hb levels supports the feasibility of anemia correction to Hb 10 g/dl , which merits further evaluation Through the establishment of blood transfusion-effectiveness assessment criteria , we aim ed to evaluate and analyze the effectiveness of peri-operative red blood cell transfusion for major orthopedics in elderly patients . Male and female patients ( n=106 ) with American Society of Anesthesiologists ( ASA ) stage II – III , aged 60–80 years and scheduled for elective orthopedic surgery were r and omly divided into 2 groups : group I ( n=52 ) , received the traditional method of red blood cell transfusion and group II ( n=54 ) received hemoglobin ( Hb ) and hematocrit ( Hct ) goal -directed red blood cell ( RBC ) transfusion . We compared the changes in Hb , Hct , RBC , platelet ( PLT ) , prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) , alveolar-arterial oxygen partial pressure [ P(A-a)O2 ] , oxygenation index ( OI ) and Vigileo monitoring indicators following RBC composition transfusion before and after surgery . We also monitored wound healing time , number of hospitalization days and intensive care unit ( ICU ) transfer rate . Blood transfusion-effectiveness assessment criteria were used to evaluate the efficacy and safety of Hb and Hct goal -directed RBC transfusion in orthopedic elderly patients . The two groups demonstrated an efficiency of 61.5 and 72.2 % , respectively ( P>0.05 ) . The P(A-a)O2 and OI in the two groups were not significantly different ( P>0.05 ) . Compared with the traditional RBC transfusion group , the Hb and Hct goal -directed RBC transfusion group presented increased RBC , Hb and Hct , as well as decreased PT and APTT and shorter wound healing time . The number of days of hospitalization and ICU transfer rate also decreased ( P<0.05 ) . The Hb and Hct goal -directed method for RBC transfusion was found to be more effective as a form of peri-operative RBC transfusion for major orthopedics in elderly patients BACKGROUND Whether a restrictive threshold for hemoglobin level in red-cell transfusions , as compared with a liberal threshold , reduces postoperative morbidity and health care costs after cardiac surgery is uncertain . METHODS We conducted a multicenter , parallel-group trial in which patients older than 16 years of age who were undergoing nonemergency cardiac surgery were recruited from 17 centers in the United Kingdom . Patients with a postoperative hemoglobin level of less than 9 g per deciliter were r and omly assigned to a restrictive transfusion threshold ( hemoglobin level < 7.5 g per deciliter ) or a liberal transfusion threshold ( hemoglobin level < 9 g per deciliter ) . The primary outcome was a serious infection ( sepsis or wound infection ) or an ischemic event ( permanent stroke [ confirmation on brain imaging and deficit in motor , sensory , or coordination functions ] , myocardial infa rct ion , infa rct ion of the gut , or acute kidney injury ) within 3 months after r and omization . Health care costs , excluding the index surgery , were estimated from the day of surgery to 3 months after surgery . RESULTS A total of 2007 patients underwent r and omization ; 4 participants withdrew , leaving 1000 in the restrictive-threshold group and 1003 in the liberal-threshold group . Transfusion rates after r and omization were 53.4 % and 92.2 % in the two groups , respectively . The primary outcome occurred in 35.1 % of the patients in the restrictive-threshold group and 33.0 % of the patients in the liberal-threshold group ( odds ratio , 1.11 ; 95 % confidence interval [ CI ] , 0.91 to 1.34 ; P=0.30 ) ; there was no indication of heterogeneity according to subgroup . There were more deaths in the restrictive-threshold group than in the liberal-threshold group ( 4.2 % vs. 2.6 % ; hazard ratio , 1.64 ; 95 % CI , 1.00 to 2.67 ; P=0.045 ) . Serious postoperative complications , excluding primary - outcome events , occurred in 35.7 % of participants in the restrictive-threshold group and 34.2 % of participants in the liberal-threshold group . Total costs did not differ significantly between the groups . CONCLUSIONS A restrictive transfusion threshold after cardiac surgery was not superior to a liberal threshold with respect to morbidity or health care costs . ( Funded by the National Institute for Health Research Health Technology Assessment program ; Current Controlled Trials number , IS RCT N70923932 . ) BACKGROUND The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial . We conducted a r and omized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture . METHODS We enrolled 2016 patients who were 50 years of age or older , who had either a history of or risk factors for cardiovascular disease , and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery . We r and omly assigned patients to a liberal transfusion strategy ( a hemoglobin threshold of 10 g per deciliter ) or a restrictive transfusion strategy ( symptoms of anemia or at physician discretion for a hemoglobin level of < 8 g per deciliter ) . The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up . RESULTS A median of 2 units of red cells were transfused in the liberal- strategy group and none in the restrictive- strategy group . The rates of the primary outcome were 35.2 % in the liberal- strategy group and 34.7 % in the restrictive- strategy group ( odds ratio in the liberal- strategy group , 1.01 ; 95 % confidence interval [ CI ] , 0.84 to 1.22 ) , for an absolute risk difference of 0.5 percentage points ( 95 % CI , -3.7 to 4.7 ) . The rates of in-hospital acute coronary syndrome or death were 4.3 % and 5.2 % , respectively ( absolute risk difference , -0.9 % ; 99 % CI , -3.3 to 1.6 ) , and rates of death on 60-day follow-up were 7.6 % and 6.6 % , respectively ( absolute risk difference , 1.0 % ; 99 % CI , -1.9 to 4.0 ) . The rates of other complications were similar in the two groups . CONCLUSIONS A liberal transfusion strategy , as compared with a restrictive strategy , did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk . ( Funded by the National Heart , Lung , and Blood Institute ; FOCUS Clinical Trials.gov number , NCT00071032 . ) IMPORTANCE There is limited information about the effect of erythropoietin or a high hemoglobin transfusion threshold after a traumatic brain injury . OBJECTIVE To compare the effects of erythropoietin and 2 hemoglobin transfusion thresholds ( 7 and 10 g/dL ) on neurological recovery after traumatic brain injury . DESIGN , SETTING , AND PARTICIPANTS R and omized clinical trial of 200 patients ( erythropoietin , n = 102 ; placebo , n = 98 ) with closed head injury who were unable to follow comm and s and were enrolled within 6 hours of injury at neurosurgical intensive care units in 2 US level I trauma centers between May 2006 and August 2012 . The study used a factorial design to test whether erythropoietin would fail to improve favorable outcomes by 20 % and whether a hemoglobin transfusion threshold of greater than 10 g/dL would increase favorable outcomes without increasing complications . Erythropoietin or placebo was initially dosed daily for 3 days and then weekly for 2 more weeks ( n = 74 ) and then the 24- and 48-hour doses were stopped for the remainder of the patients ( n = 126 ) . There were 99 patients assigned to a hemoglobin transfusion threshold of 7 g/dL and 101 patients assigned to 10 g/dL. INTERVENTIONS Intravenous erythropoietin ( 500 IU/kg per dose ) or saline . Transfusion threshold maintained with packed red blood cells . MAIN OUTCOMES AND MEASURES Glasgow Outcome Scale score dichotomized as favorable ( good recovery and moderate disability ) or unfavorable ( severe disability , vegetative , or dead ) at 6 months postinjury . RESULTS There was no interaction between erythropoietin and hemoglobin transfusion threshold . Compared with placebo ( favorable outcome rate : 34/89 [ 38.2 % ; 95 % CI , 28.1 % to 49.1 % ] ) , both erythropoietin groups were futile ( first dosing regimen : 17/35 [ 48.6 % ; 95 % CI , 31.4 % to 66.0 % ] , P = .13 ; second dosing regimen : 17/57 [ 29.8 % ; 95 % CI , 18.4 % to 43.4 % ] , P < .001 ) . Favorable outcome rates were 37/87 ( 42.5 % ) for the hemoglobin transfusion threshold of 7 g/dL and 31/94 ( 33.0 % ) for 10 g/dL ( 95 % CI for the difference , -0.06 to 0.25 , P = .28 ) . There was a higher incidence of thromboembolic events for the transfusion threshold of 10 g/dL ( 22/101 [ 21.8 % ] vs 8/99 [ 8.1 % ] for the threshold of 7 g/dL , odds ratio , 0.32 [ 95 % CI , 0.12 to 0.79 ] , P = .009 ) . CONCLUSIONS AND RELEVANCE In patients with closed head injury , neither the administration of erythropoietin nor maintaining hemoglobin concentration of greater than 10 g/dL result ed in improved neurological outcome at 6 months . The transfusion threshold of 10 g/dL was associated with a higher incidence of adverse events . These findings do not support either approach in this setting . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00313716 Background Transfusion with red blood cells ( RBC ) may be needed during hip revision surgery but the appropriate haemoglobin concentration ( Hb ) threshold for transfusion has not been well established . We hypothesized that a higher transfusion threshold would improve ambulation after hip revision surgery . Methods The trial was registered at Clinical trials.gov ( NCT00906295 ) . Sixty-six patients aged 18 years or older undergoing hip revision surgery were r and omized to receive RBC at a Hb threshold of either 7.3 g/dL ( restrictive group ) or 8.9 g/dL ( liberal group ) . Postoperative ambulation was assessed using Timed Up and Go-test ( TUG ) and ability to walk was also assessed daily by a physiotherapist blinded to the allocation . Results Fifty-three patients were able to perform the TUG and included in the analysis . The TUG could be completed in a median of 36 sec vs. 30 sec in the restrictive group and the liberal group , respectively ( P = 0.02 ) . The mean difference in TUG was 14.5 sec ( 95 % CI 2.8 - 26.2 sec ) . No difference was found in the day patients could perform TUG or walk 10 meters . The Hb at the day of testing was 10.2 g/dL in the restrictive group and 9.9 g/dL in the liberal group . Only 26 patients received RBC . Conclusions A Hb transfusion threshold of 8.9 g/dL was associated with a statistically significantly faster TUG after hip revision surgery compared to a threshold of 7.3 g/dL but the clinical importance is question able and the groups did not differ in Hb at the time of testing BACKGROUND The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial . We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy . METHODS We enrolled 921 patients with severe acute upper gastrointestinal bleeding and r and omly assigned 461 of them to a restrictive strategy ( transfusion when the hemoglobin level fell below 7 g per deciliter ) and 460 to a liberal strategy ( transfusion when the hemoglobin fell below 9 g per deciliter ) . R and omization was stratified according to the presence or absence of liver cirrhosis . RESULTS A total of 225 patients assigned to the restrictive strategy ( 51 % ) , as compared with 61 assigned to the liberal strategy ( 14 % ) , did not receive transfusions ( P<0.001 ) [corrected].The probability of survival at 6 weeks was higher in the restrictive- strategy group than in the liberal- strategy group ( 95 % vs. 91 % ; hazard ratio for death with restrictive strategy , 0.55 ; 95 % confidence interval [ CI ] , 0.33 to 0.92 ; P=0.02 ) . Further bleeding occurred in 10 % of the patients in the restrictive- strategy group as compared with 16 % of the patients in the liberal- strategy group ( P=0.01 ) , and adverse events occurred in 40 % as compared with 48 % ( P=0.02 ) . The probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the subgroup of patients who had bleeding associated with a peptic ulcer ( hazard ratio , 0.70 ; 95 % CI , 0.26 to 1.25 ) and was significantly higher in the subgroup of patients with cirrhosis and Child-Pugh class A or B disease ( hazard ratio , 0.30 ; 95 % CI , 0.11 to 0.85 ) , but not in those with cirrhosis and Child-Pugh class C disease ( hazard ratio , 1.04 ; 95 % CI , 0.45 to 2.37 ) . Within the first 5 days , the portal-pressure gradient increased significantly in patients assigned to the liberal strategy ( P=0.03 ) but not in those assigned to the restrictive strategy . CONCLUSIONS As compared with a liberal transfusion strategy , a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding . ( Funded by Fundació Investigació Sant Pau ; Clinical Trials.gov number , NCT00414713 . ) BACKGROUND Blood transfusions are frequently given to patients with septic shock . However , the benefits and harms of different hemoglobin thresholds for transfusion have not been established . METHODS In this multicenter , parallel-group trial , we r and omly assigned patients in the intensive care unit ( ICU ) who had septic shock and a hemoglobin concentration of 9 g per deciliter or less to receive 1 unit of leukoreduced red cells when the hemoglobin level was 7 g per deciliter or less ( lower threshold ) or when the level was 9 g per deciliter or less ( higher threshold ) during the ICU stay . The primary outcome measure was death by 90 days after r and omization . RESULTS We analyzed data from 998 of 1005 patients ( 99.3 % ) who underwent r and omization . The two intervention groups had similar baseline characteristics . In the ICU , the lower-threshold group received a median of 1 unit of blood ( interquartile range , 0 to 3 ) and the higher-threshold group received a median of 4 units ( interquartile range , 2 to 7 ) . At 90 days after r and omization , 216 of 502 patients ( 43.0 % ) assigned to the lower-threshold group , as compared with 223 of 496 ( 45.0 % ) assigned to the higher-threshold group , had died ( relative risk , 0.94 ; 95 % confidence interval , 0.78 to 1.09 ; P=0.44 ) . The results were similar in analyses adjusted for risk factors at baseline and in analyses of the per- protocol population s. The numbers of patients who had ischemic events , who had severe adverse reactions , and who required life support were similar in the two intervention groups . CONCLUSIONS Among patients with septic shock , mortality at 90 days and rates of ischemic events and use of life support were similar among those assigned to blood transfusion at a higher hemoglobin threshold and those assigned to blood transfusion at a lower threshold ; the latter group received fewer transfusions . ( Funded by the Danish Strategic Research Council and others ; TRISS Clinical Trials.gov number , NCT01485315 . ) Background Insight regarding transfusion practice s in Hematopoietic Stem cell Transplantation ( HSCT ) are lacking and the impact of red cell transfusion in this high risk group on outcomes following HSCT are not well appreciated . Red blood cell transfusion can be life-saving , however , liberal use of transfusion in critically ill patients failed to demonstrate significant clinical benefit . A large number of other observational studies have also demonstrated an association between red blood cell transfusions and increased morbidity such as infections and multi organ failure as well as increased mortality . The role of red cell transfusion on the clinical outcomes observed in patients undergoing HSCT remains poorly understood and a prospect i ve r and omized study of transfusion is required to gain insight and knowledge on best transfusion practice s in this high risk population . Methods This report describes the design and method ological issues of a r and omized pilot study evaluating red cell transfusion triggers in the setting of Hematopoietic Stem Cell Transplantation . This study has been funded by a peer review grant from the Canadian Blood Services and is registered on Clinical trials.gov NCT01237639 . Results In 3 Canadian centres , 100 patients undergoing Hematopoietic Stem Cell Transplantation will be r and omized to either a restrictive ( target hemoglobin of 70 - 90 g/L ) or liberal ( target hemoglobin of 90 - 110 g/L ) red cell transfusion strategy , based daily hemoglobin values up to 100 days post-transplant . The study will stratify participants by centre and type of transplant . The primary goal is to demonstrate study feasibility and we will collect clinical outcomes on 1 ) Transfusion Requirements , 2 ) Transplant Related Mortality , 3 ) Maximum grade of acute Graft versus Host Disease , 4 ) Veno-occlusive Disease , 5 ) Serious Infections , 6 ) Bearman Toxicity Score , 7 ) Bleeding , 8) Quality of Life , 9 ) Number of Hospitalizations and 10 ) Number of Intensive Care Unit ( ICU ) Admissions . Conclusion Upon completion , this pilot trial will provide preliminary insight into red cell transfusion practice and its influence in hematopoietic stem cell transplant outcomes . The results of this trial will inform the conduct of a larger study BACKGROUND Transfusion thresholds for acute upper gastrointestinal bleeding are controversial . So far , only three small , underpowered studies and one single-centre trial have been done . Findings from the single-centre trial showed reduced mortality with restrictive red blood cell ( RBC ) transfusion . We aim ed to assess whether a multicentre , cluster r and omised trial is a feasible method to substantiate or refute this finding . METHODS In this pragmatic , open-label , cluster r and omised feasibility trial , done in six university hospitals in the UK , we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding , irrespective of comorbidity , except for exsanguinating haemorrhage . We r and omly assigned hospitals ( 1:1 ) with a computer-generated r and omisation sequence ( r and om permuted block size of 6 , without stratification or matching ) to either a restrictive ( transfusion when haemoglobin concentration fell below 80 g/L ) or liberal ( transfusion when haemoglobin concentration fell below 100 g/L ) RBC transfusion policy . Neither patients nor investigators were masked to treatment allocation . Feasibility outcomes were recruitment rate , protocol adherence , haemoglobin concentration , RBC exposure , selection bias , and information to guide design and economic evaluation of the phase 3 trial . Main exploratory clinical outcomes were further bleeding and mortality at day 28 . We did analyses on all enrolled patients for whom an outcome was available . This trial is registered , IS RCT N85757829 and NCT02105532 . FINDINGS Between Sept 3 , 2012 , and March 1 , 2013 , we enrolled 936 patients across six hospitals ( 403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy ) . Recruitment rate was significantly higher for the liberal than for the restrictive policy ( 62 % vs 55 % ; p=0·04 ) . Despite some baseline imbalances , Rockall and Blatchford risk scores were identical between policies . Protocol adherence was 96 % ( SD 10 ) in the restrictive policy vs 83 % ( 25 ) in the liberal policy ( difference 14 % ; 95 % CI 7 - 21 ; p=0·005 ) . Mean last recorded haemoglobin concentration was 116 ( SD 24 ) g/L for patients on the restrictive policy and 118 ( 20 ) g/L for those on the liberal policy ( difference -2·0 [ 95 % CI -12·0 to 7·0 ] ; p=0·50 ) . Fewer patients received RBCs on the restrictive policy than on the liberal policy ( restrictive policy 133 [ 33 % ] vs liberal policy 247 [ 46 % ] ; difference -12 % [ 95 % CI -35 to 11 ] ; p=0·23 ) , with fewer RBC units transfused ( mean 1·2 [ SD 2·1 ] vs 1·9 [ 2·8 ] ; difference -0·7 [ -1·6 to 0·3 ] ; p=0·12 ) , although these differences were not significant . We noted no significant difference in clinical outcomes . INTERPRETATION A cluster r and omised design led to rapid recruitment , high protocol adherence , separation in degree of anaemia between groups , and non-significant reduction in RBC transfusion in the restrictive policy . A large cluster r and omised trial to assess the effectiveness of transfusion strategies for acute upper gastrointestinal bleeding is both feasible and essential before clinical practice guidelines change to recommend restrictive transfusion for all patients with acute upper gastrointestinal bleeding . FUNDING NHS Blood and Transplant Research and Development BACKGROUND To determine whether a restrictive strategy of red-cell transfusion and a liberal strategy produced equivalent results in critically ill patients , we compared the rates of death from all causes at 30 days and the severity of organ dysfunction . METHODS We enrolled 838 critically ill patients with euvolemia after initial treatment who had hemoglobin concentrations of less than 9.0 g per deciliter within 72 hours after admission to the intensive care unit and r and omly assigned 418 patients to a restrictive strategy of transfusion , in which red cells were transfused if the hemoglobin concentration dropped below 7.0 g per deciliter and hemoglobin concentrations were maintained at 7.0 to 9.0 g per deciliter , and 420 patients to a liberal strategy , in which transfusions were given when the hemoglobin concentration fell below 10.0 g per deciliter and hemoglobin concentrations were maintained at 10.0 to 12.0 g per deciliter . RESULTS Overall , 30-day mortality was similar in the two groups ( 18.7 percent vs. 23.3 percent , P= 0.11 ) . However , the rates were significantly lower with the restrictive transfusion strategy among patients who were less acutely ill -- those with an Acute Physiology and Chronic Health Evaluation II score of < or = 20 ( 8.7 percent in the restrictive- strategy group and 16.1 percent in the liberal- strategy group ; P=0.03 ) -- and among patients who were less than 55 years of age ( 5.7 percent and 13.0 percent , respectively ; P=0.02 ) , but not among patients with clinical ly significant cardiac disease ( 20.5 percent and 22.9 percent , respectively ; P=0.69 ) . The mortality rate during hospitalization was significantly lower in the restrictive- strategy group ( 22.3 percent vs. 28.1 percent , P=0.05 ) . CONCLUSIONS A restrictive strategy of red-cell transfusion is at least as effective as and possibly superior to a liberal transfusion strategy in critically ill patients , with the possible exception of patients with acute myocardial infa rct ion and unstable angina BACKGROUND AND OBJECTIVES Transfusion with allogeneic red blood cells ( RBCs ) may be needed to maintain oxygen delivery during major surgery , but the appropriate haemoglobin ( Hb ) concentration threshold has not been well established . We hypothesised that a higher level of Hb would be associated with improved subcutaneous oxygen tension during major spinal surgery . MATERIAL S AND METHODS Fifty patients aged 18 years or older scheduled for spinal fusion with instrumentation were included and r and omised to receive RBCs at either a Hb concentration of 7·3 g dL(-1 ) ( restrictive group ) or a Hb concentration of 8·9 g dL(-1 ) ( liberal group ) ( Registration no. : H-C-2009 - 072 ) . Oxygen tension was measured with a polarographic electrode placed subcutaneously over the left deltoid muscle . The primary endpoint was subcutaneous oxygen tension at the time most patients were still undergoing surgery . RESULTS Forty-eight patients were included in the intention-to-treat analysis ; 25 patients in the restrictive group and 23 patients in the liberal group . The median change in subcutaneous oxygen tension 60 min after surgical incision was -0·79 and -0·75 kPa in the restrictive and the liberal groups , respectively ( P = 0·78 ) . No significant difference was found in the lowest subcutaneous oxygen tension ; -2·07 vs. -1·95 kPa in the restrictive and the liberal groups , respectively ( P = 0·85 ) . CONCLUSION A Hb concentration transfusion threshold of 8·9 g dL(-1 ) was not associated with a higher subcutaneous oxygen tension during major spinal surgery than a threshold of 7·3 g dL(-1 ) , but the trial was compromised by method ological difficulties BACKGROUND Debate exists as to what should be the transfusion threshold for patients with anaemia after hip fracture surgery . METHODS A total of 200 patients aged 60 years and above with a haemoglobin level of between 8.0 and 9.5gdl(-1 ) after hip fracture surgery were r and omised to receive a transfusion to raise the haemoglobin to at least 10.0gdl(-1 ) or not to have a transfusion unless definite symptoms of anaemia became apparent . Patients were followed up for 1 year . RESULTS There was no statistically significant difference in the outcomes of mortality , hospital stay , regain of mobility or complications between the two groups . CONCLUSIONS This study confirms other recent research studies which found that reducing the transfusion threshold to 8.0gdl(-1 ) appears to be a safe practice for this group of patients BACKGROUND Perioperative myocardial infa rct ion ( MI ) is a serious complication after noncardiac surgery . We hypothesized that preoperative cardiac troponin T detected with a novel high-sensitivity ( hs-cTnT ) assay will identify patients at risk for acute MI and long-term mortality after major noncardiac surgery . METHODS This was a prospect i ve cohort study within the VINO trial ( n = 608 ) . Patients had been diagnosed with or had multiple risk factors for coronary artery disease and underwent major noncardiac surgery . Cardiac troponin I ( contemporary assay ) and troponin T ( high-sensitivity assay ) and 12-lead electrocardiograms were obtained before and immediately after surgery and on postoperative days 1 , 2 , and 3 . RESULTS At baseline before surgery , 599 patients ( 98.5 % ) had a detectable hs-cTnT concentration , and 247 ( 41 % ) were > 14 ng/L ( 99th percentile ) . After surgery , 497 patients ( 82 % ) had a rise in hs-cTnT ( median change in hs-cTnT + 2.7 ng/L [ interquartile range 0.7 - 6.8 ] ) . During the first 3 postoperative days , there were 9 patients ( 2.5 % ) with a preoperative hs-cTnT < 14 ng/L with acute MI , compared with 21 patients ( 8.6 % ) with a preoperative hs-cTnT > 14 ng/L ( odds ratio 3.67 , 95 % CI 1.65 - 8.15 ) . During long-term follow-up , 80 deaths occurred . The 3-year mortality rate was 11 % in patients with a preoperative hs-cTnT concentration < 14 ng/L compared with 25 % in patients with a preoperative hs-cTnT > 14 ng/L ( adjusted hazard ratio 2.17 , 95 % CI 1.19 - 3.96 ) . CONCLUSIONS In this cohort of high-risk patients , preoperative hs-cTnT concentrations were significantly associated with postoperative MI and long-term mortality after noncardiac surgery BACKGROUND The indications for transfusion have never been evaluated in an adequately sized clinical trial . A pilot study was conducted to plan larger clinical trials . STUDY DESIGN AND METHODS Hip fracture patients undergoing surgical repair who had postoperative hemoglobin levels less than 10 g per dL were r and omly assigned to receive 1 ) symptomatic transfusion : that is , transfusion for symptoms of anemia or for a hemoglobin level that dropped below 8 g per dL or 2 ) threshold transfusion : that is , patients receive 1 unit of packed RBCs at the time of r and om assignment and as much blood as necessary to keep the hemoglobin level above 10 g per dL. Outcomes were 60-day mortality , morbidity , functional status , and place of residence . RESULTS Among 84 eligible patients enrolled , mean ( + /- SD ) prer and omization hemoglobin was 9.1 ( + /- 0.6 ) g/ dL. The median number of units transfused in the threshold transfusion group was 2 ( interquartile range , = 1 - 2 ) , and that in the symptomatic transfusion group was 0 ( 6 ; interquartile range , = 0 - 2 ) ( p < 0.001 ) . Mean hemoglobin levels were approximately 1 g per dL higher in the threshold group than in the symptomatic group : for example , on Day 2 , 10.3 ( + /- 0.9 ) g per dL versus 9.3 ( + /- 1.2 ) g per dL , respectively ( p < 0.001 ) . At 60 days , death or inability to walk across the room without assistance occurred in 16 ( 39.0 % ) of the symptomatic transfusion group and 19 ( 45.2 % ) of the threshold transfusion group . Death occurred by 60 days in 5 ( 11.9 % ) of the symptomatic transfusion group and 2 ( 4.8 % ) in the threshold transfusion group ( relative risk = 2.5 ; 95 % CI , 0.5 - 12.2 ) . Other outcomes were similar for the two groups . CONCLUSIONS Symptomatic transfusion may be an effective blood-sparing protocol associated with the transfusion of appreciably fewer units of RBCs and lower mean hemoglobin levels than are associated with the threshold transfusion policy . However , it is unknown whether these two clinical strategies have comparable mortality , morbidity , or functional status . A definitive trial is needed Prophylactic blood transfusion has come to be regarded as necessary in the treatment of patients with sickle cell disease during pregnancy . Because of the risks associated with blood products and reports of successful outcomes without the use of blood transfusion , we conducted a prospect i ve r and omized controlled study of this issue . Seventy-two pregnant patients with sickle cell anemia were r and omly assigned to one of two treatment groups : 36 received prophylactic transfusions of frozen red cells , and 36 received red-cell transfusions only for medical or obstetric emergencies . Twenty-eight patients with sickle cell anemia who did not qualify for r and omization ( mainly because they had other medical disorders ) , 66 with sickle cell-hemoglobin C disease , and 23 with sickle cell-beta-thalassemia were also followed and received transfusions only for emergencies . There was no significant difference in perinatal outcome between the offspring of mothers with sickle cell disease who were assigned to treatment with prophylactic transfusions and those who were not ( 15 vs. 5 percent ) . The occurrence of a perinatal death in a previous pregnancy and the presence of twins in the present pregnancy were two major risk factors for an unfavorable outcome ; when they were present , perinatal mortality was 50 percent . Perinatal mortality was somewhat higher in the two groups that were r and omized than in the three groups that were not . Prophylactic transfusion significantly reduced the incidence of painful crises of sickle cell disease ( P less than 0.01 ) and substantially reduced the cumulative incidence of other complications of this disorder ( P = 0.07 ) . Other medical and obstetric complications occurred with nearly equal frequency in the two r and omized groups . Increases in costs , the number of hospitalizations , and the risk of alloimmunization were disadvantages of prophylactic transfusion . We conclude that the omission of prophylactic red-cell transfusion will not harm pregnant patients with sickle cell disease or their offspring Red blood cell transfusion is common in patients with acute myocardial infa rct ion ( AMI ) . However , observational data suggest that this practice may be associated with worse clinical outcomes and data from clinical trials are lacking in this population . We conducted a prospect i ve multicenter r and omized pilot trial in which 45 patients with AMI and a hematocrit level ≤30 % were r and omized to a liberal ( transfuse when hematocrit < 30 % to maintain 30 % to 33 % ) or a conservative ( transfuse when hematocrit < 24 % to maintain 24 % to 27 % ) transfusion strategy . Baseline hematocrit was similar in those in the liberal and conservative arms ( 26.9 % vs 27.5 % , p = 0.4 ) . Average daily hematocrits were 30.6 % in the liberal arm and 27.9 % in the conservative arm , a difference of 2.7 % ( p < 0.001 ) . More patients in the liberal arm than in the conservative arm were transfused ( 100 % vs 54 % , p < 0.001 ) and the average number of units transfused per patient tended to be higher in the liberal arm than in the conservative arm ( 2.5 vs 1.6 , p = 0.07 ) . The primary clinical safety measurement of in-hospital death , recurrent MI , or new or worsening congestive heart failure occurred in 8 patients in the liberal arm and 3 in the conservative arm ( 38 % vs 13 % , p = 0.046 ) . In conclusion , compared to a conservative transfusion strategy , treating anemic patients with AMI according to a liberal transfusion strategy results in more patients receiving transfusions and higher hematocrit levels . However , this may be associated with worse clinical outcomes . A large-scale definitive trial addressing this issue is urgently required The ' optimal ' hematocrit to which patients should be resuscitated after shock and trauma is controversial . To test the hypothesis that sufficient oxygen delivery can be provided at a lower hematocrit without impairing oxygen consumption or hemodynamic function , 25 patients were prospect ively studied immediately following injury and /or acute hemorrhage . Patients were r and omized to have their hematocrits ( HCT ) maintained near 30 % ( 29.7 + /- 0.4 % ( M + /- SEM ) ; n = 12 ) or 40 % ( 38.4 + /- 0.6 % , n = 13 ) . Cardiopulmonary parameters were measured twice a day for 3 days . Statistical analysis used a repeated measures analysis of variance with patient age , and ventilator parameters ( FIO2 , PEEP , and ventilator mode ) as covariates . Arterial and venous O2 saturations were not significantly different at different hematocrits , although arterial and venous O2 contents were lower at 30 % HCT ( a = 14.1 + /- 0.2 m10(2)/dl , v = 10.1 + /- 0.3 m10(2)/dl ; vs. a = 17.4 + /- 0.4 m10(2)/dl , v = 13.6 + /- 0.6 m10(2)/dl ; p less than 0.05 ) . This result ed in a lower oxygen delivery at the lower HCT . Between the two groups , there also was no significant difference in cardiac index ( overall mean , 3.64 + /- 0.16 ml/min/m2 ) , heart rate ( 99 + /- 4 bpm ) , systemic vascular resistance ( 1,058 + /- 55 dyne-sec/cm5 ) , or left ventricular stroke work index ( 4.3 + /- 0.3 X 10(6 ) dyne-cm/m2 ) . Intrapulmonary shunt was higher with higher hematocrit ( 22.6 + /- 2.4 % at 40 % HCT vs. 14.6 + /- 1.6 % at 30 % HCT ; p less than 0.05 ) with no difference in end-expiratory pressure . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Prior trials suggest it is safe to defer transfusion at hemoglobin levels above 7 to 8 g/dL in most patients . Patients with acute coronary syndrome may benefit from higher hemoglobin levels . METHODS We performed a pilot trial in 110 patients with acute coronary syndrome or stable angina undergoing cardiac catheterization and a hemoglobin < 10 g/dL. Patients in the liberal transfusion strategy received one or more units of blood to raise the hemoglobin level ≥10 g/dL. Patients in the restrictive transfusion strategy were permitted to receive blood for symptoms from anemia or for a hemoglobin < 8 g/dL. The predefined primary outcome was the composite of death , myocardial infa rct ion , or unscheduled revascularization 30 days post r and omization . RESULTS Baseline characteristics were similar between groups except age ( liberal , 67.3 ; restrictive , 74.3 ) . The mean number of units transfused was 1.6 in the liberal group and 0.6 in the restrictive group . The primary outcome occurred in 6 patients ( 10.9 % ) in the liberal group and 14 ( 25.5 % ) in the restrictive group ( risk difference = 15.0 % ; 95 % confidence interval of difference 0.7 % to 29.3 % ; P = .054 and adjusted for age P = .076 ) . Death at 30 days was less frequent in liberal group ( n = 1 , 1.8 % ) compared to restrictive group ( n = 7 , 13.0 % ; P = .032 ) . CONCLUSIONS The liberal transfusion strategy was associated with a trend for fewer major cardiac events and deaths than a more restrictive strategy . These results support the feasibility of and the need for a definitive trial The effect of citrated stored blood on coagulation was studied initially in a pilot study where 25 patients with acute severe gastrointestinal haemorrhage had their whole blood coagulation measured using the Biobridge Impedance Clotting Time ( ICT ) . This demonstrated that there is a hypercoagulable response to haemorrhage which was partially reversed by blood transfusion . Similar changes were noted in Kaolin Cephalin Clotting Times ( KCCT ) . A further 50 patients were then r and omized to receive , during the 24h after admission , either at least 2 units of blood or no blood transfusion unless the haemoglobin fell below 8 g/dl or they were shocked . In the transfused group nine patients re‐bled compared with only one in the non‐transfused group ( P < 0·01 , χ2 with Yates ' correction ) . Early blood transfusion appears to reverse the hypercoagulable response to haemorrhage thereby encouraging rebleeding and hence the need for an operation Few studies have examined the association between perioperative blood transfusion and postoperative delirium ( POD ) in aged patients undergoing total hip replacement surgery . In this prospect i ve study , 186 patients older than 65 years undergoing elective unilateral total hip replacement surgery were enrolled . Of those , 94 patients were r and omly assigned to the restrictive strategy transfusion strategy group , in which red blood cells were transfused in order to maintain 10.0 g/dL > hemoglobin≧8.0 g/dL. Ninety-two patients were r and omly assigned to the liberal transfusion strategy group , in which red blood cells were transfused in order to maintain hemoglobin≧10.0 g/dL. POD was diagnosed by confusion assessment method . The baseline characteristics of patients , the length of hospital stay , the incidence of POD , myocardial infa rct ion , stroke , wound infection , pulmonary embolism , and the transfusion volume were recorded . No difference was observed in the baseline characteristics , the length of hospital stay , and the incidence of POD , myocardial infa rct ion , stroke , wound infection , and pulmonary embolism between the two groups ( P>0.05 ) . The proportion of patients transfused with red blood cell and frozen plasma was decreased in the restrictive transfusion group compared with the liberal transfusion group ( P<0.05 ) . In conclusion , restrictive transfusion does not influence the incidence of POD but reduces blood transfusion . Thus , restrictive transfusion may serve as an effective and safe strategy for aged patients following total hip replacement Red cells transfusion in the patient with acute hemorrhage , must be evaluated in a risk/benefit rate context . The present tendencies appoint that the use of the hematocrit " magic " number is unsafe and uncertain to decide a red cell transfusion . We have conducted a prospect i ve r and omized and controlled trial in 60 patients with acute digestive hemorrhage without haemodynamic failure . We realized two groups : 1 ) control group : the target of transfusion in these patients was the hematocrit value of > or = 28 % . 2 ) treatment group : these patients were supported with normovolemic haemodilution with crystalloid solutions until a hematocrit value of 21 % . All patients have endoscopic diagnosis and they went evaluated across the study with clinic and laboratory controls . Both groups were significative differences in the hematocrit value . We did not see differences between the groups in the hospital stay neither the rate of organs failure . We find difference between the groups in the amount of red cell units ( 0.61 + /- 0.87 vs. 2.14 + /- 1.10 ; treatment and control respectively , P < 0.001 ) . The APACHE score was greater in the treatment group . This supports that the oldest patients , who probably have least physiologic reserve , could be treated without complications . Acute hemorrhage-normovolemic haemodilution-digestive hemorrhage transfusion Objective : Clinical trial design s that r and omize patients to fixed treatment regimens may disrupt preexisting relationships between illness severity and level of therapy . The practice misalignments created by such design s may have unintended effects on trial results and safety . Methods : To illustrate this problem , the Transfusion Requirements in Critical Care ( TRICC ) trial and the Acute Respiratory Distress Syndrome Network low tidal volume ( ARMA ) trial were analyzed . Results : Publications before TRICC indicated that clinicians used higher transfusion thresholds in patients with ischemic heart disease compared with younger , healthier patients ( p = .001 ) . The trial , however , r and omized patients ( n = 838 ) to liberal ( 10 g/dL hemoglobin ) or restrictive ( 7 g/dL ) transfusion thresholds . Thirty-day mortality was different and opposite in the liberal compared with the restrictive arm depending on presence ( 21 vs. 26 % ) or absence ( 25 vs. 16 % ) of ischemic heart disease ( p = .03 ) . At baseline in ARMA , consistent with prior publications , physicians set ventilator volumes lower in patients with high airway pressures and poor compliance ( 8.4–10.6 mL/kg interquartile range ) than patients with less severe abnormalities ( 9.6–12 mL/kg ) ( p = .0001 ) . In the trial , however , patients ( n = 861 ) were r and omized to low ( 6 mL/kg ) or high ( 12 mL/kg ) tidal volumes . In patients with low compliance ( < 0.6 mL/kg ) , 28-day mortality was higher when tidal volumes were raised rather than lowered ( 42 vs. 29 % ) , but this effect was reversed in patients with higher compliance ( 21 vs. 37 % ; p = .003 ) . Conclusions : In TRICC and ARMA , r and omization to fixed treatment regimens disrupted preexisting relationships between illness severity and therapy level . This created noncomparable subgroups in both study arms that received care different and opposite from titrated care , that is , practice misalignments . These subgroups reduced the interpretability and safety of each trial . Characterizing current practice , incorporating current practice controls , and using alternative trial design s to minimize practice misalignments should improve trial safety and interpretability Efforts to avoid complications associated with transfusion of allogeneic blood have increased the use of preoperatively donated autologous blood ( PAB ) . A major controversy has arisen : Should the same criteria be used for transfusion of autologous as allogeneic red cells ? This study prospect ively and r and omly compared giving PAB immediately after total knee arthroplasty ( TKA ) , beginning in the recovery room or delaying a transfusion until the patient 's hemoglobin had fallen to less than a 9.0 g/dL transfusion trigger point . The results show that patients who received immediate transfusion had fewer nonsurgical complications ( P < .002 ) . Because TKAs are associated with an average blood loss of 1,400 mL , we recommend that PAB be used in the immediate postoperative period , especially in the elderly , in whom the risk for cardiac or nonsurgical complications is inherently increased BACKGROUND Anemia may be an important factor contributing to an increased risk of bleeding , particularly in patients with thrombocytopenia . STUDY DESIGN AND METHODS A multicenter , single-blinded pilot r and omized controlled trial ( RCT ) was performed to evaluate the feasibility of conducting a larger RCT to determine the effect of the hemoglobin ( Hb ) concentration on bleeding risk . Patients with acute leukemia receiving induction chemotherapy or those undergoing stem cell transplantation were assigned to one of two treatment groups : st and ard transfusion strategy ( transfusion of 2 units of red blood cells [ RBCs ] when their Hb level was less than 80 g/L ) or an augmented transfusion strategy ( transfusion of 2 units of RBCs when their Hb level was less than 120 g/L ) . RESULTS Sixty patients were enrolled : 29 in the control group and 31 in the experimental group . The proportions of patients experiencing clinical ly significant bleeding and the time to first bleed were not significantly different between the control and experimental groups . The experimental group received more RBC transfusions ( transfusions/patient-day ) than the control group ( 0.233 vs. 0.151 ; relative risk , 1.56 ; 95 % confidence interval , 1.16 - 2.10 ; p = 0.003 ) . The proportion of patient-days with platelet ( PLT ) transfusions was not different between the experimental and control groups . The mean number of donor exposures ( PLT and RBC transfusions ) was not different between experimental and control groups . Bleeding symptoms were systematic ally documented . CONCLUSION This pilot study thus indicated that it would be feasible to enroll the required number of patients to enable the performance of a large RCT to investigate the effect of Hb on bleeding risk in thrombocytopenic patients Background : Myocardial injury after noncardiac surgery ( MINS ) was defined as prognostically relevant myocardial injury due to ischemia that occurs during or within 30 days after noncardiac surgery . The study ’s four objectives were to determine the diagnostic criteria , characteristics , predictors , and 30-day outcomes of MINS . Methods : In this international , prospect i ve cohort study of 15,065 patients aged 45 yr or older who underwent in-patient noncardiac surgery , troponin T was measured during the first 3 postoperative days . Patients with a troponin T level of 0.04 ng/ml or greater ( elevated “ abnormal ” laboratory threshold ) were assessed for ischemic features ( i.e. , ischemic symptoms and electrocardiography findings ) . Patients adjudicated as having a nonischemic troponin elevation ( e.g. , sepsis ) were excluded . To establish diagnostic criteria for MINS , the authors used Cox regression analyses in which the dependent variable was 30-day mortality ( 260 deaths ) and independent variables included preoperative variables , perioperative complications , and potential MINS diagnostic criteria . Results : An elevated troponin after noncardiac surgery , irrespective of the presence of an ischemic feature , independently predicted 30-day mortality . Therefore , the authors ’ diagnostic criterion for MINS was a peak troponin T level of 0.03 ng/ml or greater judged due to myocardial ischemia . MINS was an independent predictor of 30-day mortality ( adjusted hazard ratio , 3.87 ; 95 % CI , 2.96–5.08 ) and had the highest population -attributable risk ( 34.0 % , 95 % CI , 26.6–41.5 ) of the perioperative complications . Twelve hundred patients ( 8.0 % ) suffered MINS , and 58.2 % of these patients would not have fulfilled the universal definition of myocardial infa rct ion . Only 15.8 % of patients with MINS experienced an ischemic symptom . Conclusion : Among adults undergoing noncardiac surgery , MINS is common and associated with substantial mortality Objectives : To compare hemoglobin concentration ( Hb ) , RBC use , and patient outcomes when restrictive or liberal blood transfusion strategies are used to treat anemic ( Hb ⩽ 90 g/L ) critically ill patients of age ≥ 55 years requiring ≥ 4 days of mechanical ventilation in ICU . Design : Parallel-group r and omized multicenter pilot trial . Setting : Six ICUs in the United Kingdom participated between August 2009 and December 2010 . Patients : One hundred patients ( 51 restrictive and 49 liberal groups ) . Interventions : Patients were r and omized to a restrictive ( Hb trigger , 70 g/L ; target , 71–90 g/L ) or liberal ( 90 g/L ; target , 91–110 g/L ) transfusion strategy for 14 days or the remainder of ICU stay , whichever was longest . Measurements and Main Results : Baseline comorbidity rates and illness severity were high , notably for ischemic heart disease ( 32 % ) . The Hb difference among groups was 13.8 g/L ( 95 % CI , 11.5–16.0 g/L ) ; p < 0.0001 ) ; mean Hb during intervention was 81.9 ( SD , 5.1 ) versus 95.7 ( 6.3 ) g/L ; 21.6 % fewer patients in the restrictive group were transfused postr and omization ( p < 0.001 ) and received a median 1 ( 95 % CI , 1–2 ; p = 0.002 ) fewer RBC units . Protocol compliance was high . No major differences in organ dysfunction , duration of ventilation , infections , or cardiovascular complications were observed during intensive care and hospital follow-up . Mortality at 180 days postr and omization trended toward higher rates in the liberal group ( 55 % ) than in the restrictive group ( 37 % ) ; relative risk was 0.68 ( 95 % CI , 0.44–1.05 ; p = 0.073 ) . This trend remained in a survival model adjusted for age , gender , ischemic heart disease , Acute Physiology and Chronic Health Evaluation II score , and total non-neurologic Sequential Organ Failure Assessment score at baseline ( hazard ratio , 0.54 [ 95 % CI , 0.28–1.03 ] ; p = 0.061 ) . Conclusions : A large trial of transfusion strategies in older mechanically ventilated patients is feasible . This pilot trial found a nonsignificant trend toward lower mortality with restrictive transfusion practice |
1,303 | 28,501,795 | Conclusions Many patients require a substantial risk reduction before they consider taking a daily medication worthwhile , even when the medication is described as being side effect free and costless | Objective To systematic ally review current evidence regarding the minimum acceptable risk reduction of a cardiovascular event that patients feel would justify daily intake of a preventive medication . | Background Despite increasing recognition of the importance of involving patients in decisions on preventive healthcare interventions , little is known about how well patients underst and and utilise information provided on the relative benefits from these interventions . The aim of this study was to explore whether lay people can discriminate between preventive interventions when effectiveness is presented in terms of relative risk reduction ( RRR ) , and whether such discrimination is influenced by presentation of baseline risk . Methods The study was a r and omised cross-sectional interview survey of a representative sample ( n = 1,519 ) of lay people with mean age 59 ( range 40–98 ) years in Denmark . In addition to demographic information , respondents were asked to consider a hypothetical drug treatment to prevent heart attack . Its effectiveness was r and omly presented as RRR of 10 , 20 , 30 , 40 , 50 or 60 percent , and half of the respondents were presented with quantitative information on the baseline risk of heart attack . The respondents had also been asked whether they were diagnosed with hypercholesterolemia or had experienced a heart attack . Results In total , 873 ( 58 % ) of the respondents consented to the hypothetical treatment . While 49 % accepted the treatment when RRR = 10 % , the acceptance rate was 58–60 % for RRR>10 . There was no significant difference in acceptance rates across respondents irrespective of whether they had been presented with quantitative information on baseline risk or not . Conclusion In this study , lay people 's decisions about therapy were only slightly influenced by the magnitude of the effect when it was presented in terms of RRR . The results may indicate that lay people have difficulties in discriminating between levels of effectiveness when they are presented in terms of RRR BACKGROUND It is important that patients are well-informed about risks and benefits of therapies to help them decide whether to accept medical therapy . Different numerical formats can be used in risk communication but It remains unclear how the different formats affect decisions made by real-life patients . AIM To compare the impact of using Prolongation Of Life ( POL ) and Absolute Risk Reduction ( ARR ) information formats to express effectiveness of cholesterol-lowering therapy on patients ' redemptions of statin prescriptions , and on patients ' confidence in their decision and satisfaction with the risk communication . DESIGN AND SETTING Cluster-r and omised clinical trial in general practice s. Thirty-four Danish GPs from 23 practice s participated in a primary care-based clinical trial concerning use of quantitative effectiveness formats for risk communication in health prevention consultations . METHOD GPs were cluster-r and omised ( treating practice s as clusters ) to inform patients about cardiovascular mortality risk and the effectiveness of statin treatment using either POL or ARR formats . Patients ' redemptions of statin prescriptions were obtained from a regional prescription data base . The COMRADE question naire was used to measure patients ' confidence in their decision and satisfaction with the risk communication . RESULTS Of the 240 patients included for analyses , 112 were allocated to POL information and 128 to ARR . Patients redeeming a statin prescription totalled six ( 5.4 % ) when informed using POL , and 32 ( 25.0 % ) when using ARR . The level of confidence in decision and satisfaction with risk communication did not differ between the risk formats . CONCLUSION Patients redeemed statin prescriptions less often when their GP communicated treatment effectiveness using POL compared with ARR Background Different presentations of treatment effects can affect decisions . However , previous studies have not evaluated which presentations best help people make decisions that are consistent with their own values . We undertook a pilot study to compare different methods for doing this . Methods and Findings We conducted an Internet-based r and omized trial comparing summary statistics for communicating the effects of statins on the risk of coronary heart disease ( CHD ) . Participants rated the relative importance of treatment consequences using visual analogue scales ( VAS ) and category rating scales ( CRS ) with five response options . We r and omized participants to either VAS or CRS first and to one of six summary statistics : relative risk reduction ( RRR ) and five absolute measures of effect : absolute risk reduction , number needed to treat , event rates , tablets needed to take , and natural frequencies ( whole numbers ) . We used logistic regression to determine the association between participants ' elicited values and treatment choices . 770 participants age 18 or over and literate in English completed the study . In all , 13 % in the VAS-first group failed to complete their VAS rating , while 9 % of the CRS-first group failed to complete their scoring ( p = 0.03 ) . Different ways of weighting the elicited values had little impact on the analyses comparing the different presentations . Most ( 51 % ) preferred the RRR compared to the other five summary statistics ( 1 % to 25 % , p = 0.074 ) . However , decisions in the group presented the RRR deviated substantially from those made in the other five groups . The odds of participants in the RRR group deciding to take statins were 3.1 to 5.8 times that of those in the other groups across a wide range of values ( p = 0.0007 ) . Participants with a scientific background , who were more numerate or had more years of education were more likely to decide not to take statins . Conclusions Internet-based trials comparing different presentations of treatment effects are feasible , but recruiting participants is a major challenge . Despite a slightly higher response rate for CRS , VAS is preferable to avoid approximation of a continuous variable . Although most participants preferred the RRR , participants shown the RRR were more likely to decide to take statins regardless of their values compared with participants who were shown any of the five other summary statistics . Trial Registration Controlled-Trials.com IS RCT # # # # Summary box Measurement of blood pressure is an iconic part of modern medicine . Over the past century , life insurers , public health organisations , and prospect i ve studies , including the Framingham Heart Study , have established the relation between increased blood pressure and long term morbidity and mortality.1 About Graphic representation was used to explore to what extent the number needed to treat ( NNT ) conveys the appropriate notion of benefit for the individual patient in interventions aim ed at delaying adverse events . A sample of the Danish population ( n = 675 ) was interviewed face to face , and asked whether they would consent to a hypothetical drug that reduces the risk of heart attack . The benefit of the drug was expressed in terms of NNT and was r and omly set at 10 , 25 , 50 , 100 , 200 , and 400 . NNT does not convey information on the proportion of patients being helped by an intervention or the size of the delay of the adverse event intended to be prevented . The proportion of people consenting to the hypothetical drug was about 80 % , irrespective of NNT , and some of those who rejected the drug misinterpreted the meaning of NNT . Lay people may have difficulties in underst and ing the meaning of NNT , and clinicians may do well to use the NNT with caution until more is known about how patients comprehend it Background Shared decision-making and patients ’ choice of interventions are areas of increasing importance , not least seen in the light of the fact that chronic conditions are increasing , interventions considered important for public health , and still non-acceptance of especially risk-reducing treatments of cardiovascular diseases ( CVD ) is prevalent . A better underst and ing of patients ’ medication-taking behavior is needed and may be reached by study ing the reasons why people accept or decline medication recommendations . The aim of this paper was to identify factors that may influence people ’s decisions and reasoning for accepting or declining a cardiovascular preventive medication offer . Methods From a r and om sample of 4,000 people aged 40–59 years in a Danish population , 1,169 participants were asked to imagine being at increased risk of cardiovascular disease and being offered a preventive medication . After receiving ‘ complete ’ information about effectiveness of the medication they were asked whether they would accept medication . Finally , they were asked about reasons for the decision . Results A total of 725 ( 67 % ) of 1,082 participants accepted the medication offer . Even quite large effects of medication ( up to 8 percentage points absolute risk reduction ) had a smaller impact on acceptance to medication than personal experience with cardiovascular disease . Furthermore , increasing age of the participant and living with a partner were significantly associated with acceptance . Some 45 % of the respondents accepting justified their choice as being for health reasons , and they were more likely to be women , live alone , have higher income and higher education levels . Among those who did not accept the medication offer , 56 % indicated that they would rather prefer to change lifestyle . Conclusions Medication effectiveness seems to have a moderate influence on people ’s decisions to accept preventive medication , while factors such as personal experience with cardiovascular disease may have an equally strong or stronger influence , indicating that practitioners could do well to carefully identify the reasons for their patients ’ treatment decisions Background For shared decision making doctors need to communicate the effectiveness of therapies such that patients can underst and it and discriminate between small and large effects . Previous research indicates that patients have difficulties in underst and ing risk measures . This study aim ed to test the hypothesis that lay people may be able to discriminate between therapies when their effectiveness is expressed in terms of postponement of an adverse disease event . Methods In 2004 a r and om sample of 1,367 non-institutionalized Danes aged 40 + was interviewed in person . The participants were asked for demographic information and asked to consider a hypothetical preventive drug treatment . The respondents were r and omized to the magnitude of treatment effectiveness ( heart attack postponement of 1 month , 6 months , 12 months , 2 years , 4 years and 8 years ) and subsequently asked whether they would take such a therapy . They were also asked whether they had hypercholesterolemia or had experienced a heart attack . Results In total 58 % of the respondents consented to the hypothetical treatment . The proportions accepting treatment were 39 % , 52 % , 56 % , 64 % , 67 % and 73 % when postponement was 1 month , 6 months , 12 months , 2 years , 4 years and 8 years respectively . Participants who thought that the effectiveness information was difficult to underst and , were less likely to consent to therapy ( p = 0.004 ) . Conclusion Lay people can discriminate between levels of treatment effectiveness when they are presented in terms of postponement of an adverse event . The results indicate that such postponement is a comprehensible measure of effectiveness Background There is uncertainty about how GPs should convey information about treatment effectiveness to their patients in the context of cardiovascular disease . Hence we study the concordance of decisions based on one of four single information formats for treatment effectiveness with subsequent decisions based on all four formats combined with a pictorial representation . Methods A r and omized study comprising 1,169 subjects aged 40–59 in Odense , Denmark . Subjects were r and omized to receive information in terms of absolute risk reduction ( ARR ) , relative risk reduction ( RRR ) , number needed to treat ( NNT ) , or prolongation of life ( POL ) without heart attack , and were asked whether they would consent to treatment . Subsequently the same information was conveyed with all four formats jointly accompanied by a pictorial presentation of treatment effectiveness . Again , subjects should consider consent to treatment . Results After being informed about all four formats , 52%–79 % of the respondents consented to treatment , depending on level of effectiveness and initial information format . Overall , ARR gave highest concordance , 94 % ( 95 % confidence interval ( 91 % ; 97 % ) ) between initial and final decision , but ARR was not statistically superior to the other formats . Conclusion Decisions based on ARR had the best concordance with decisions based on all four formats and pictorial representation , but the difference in concordance between the four formats was small , and it is unclear whether respondents fully understood the information they received BACKGROUND The number needed to treat ( NNT ) has been promoted as the preferred effect measure when patients and physicians share decision making . Our aim was to explore the impact of the NNT on laypeople 's decisions about preventive drug therapies . METHODS Two thous and subjects were selected for the survey ; 1201 ( 60 % ) responded for a representative sample of the Norwegian population . Respondents were allocated to scenarios with r and om combinations of a disease to be prevented , drug treatment costs , and effect size in terms of NNT . They were interviewed about their hypothetical consent to the therapy , then r and omized to different interpretations of NNT and asked to reconsider their initial responses . RESULTS The proportions consenting varied from 76 % when the NNT was 50 to 67 % when the NNT was 1600 ( P for trend = .06 ) . When faced with the prospect of avoiding lethal disease , stroke , myocardial infa rct ion , or hip fracture , the proportions consenting were 84 % , 76 % , 68 % , and 53 % , respectively ( P<.01 ) . Across different treatment costs ( $ 37 , $ 68 , $ 162 , and $ 589 ) the proportions consenting varied from 78 % to 61 % ( P for trend < .01 ) . Twenty-four percent of the respondents changed their decision when informed about how to interpret the NNT , and 93 % of those switched from positive to negative decisions , regardless of the magnitude of NNT . CONCLUSIONS Respondents ' decisions were influenced by the type of disease to be prevented and the cost of the intervention , but not by the effect size in terms of NNT . This suggests that NNT is difficult to underst and and that other effect formats should be considered for shared decision making Background We conducted an Internet-based r and omized trial comparing three valence framing presentations of the benefits of antihypertensive medication in preventing cardiovascular disease ( CVD ) for people with newly diagnosed hypertension to determine which framing presentation result ed in choices most consistent with participants ' values . Methods and Findings In this second in a series of televised trials in cooperation with the Norwegian Broadcasting Company , adult volunteers rated the relative importance of the consequences of taking antihypertensive medication using visual analogue scales ( VAS ) . Participants viewed information ( or no information ) to which they were r and omized and decided whether or not to take medication . We compared positive framing over 10 years ( the number escaping CVD per 1000 ) ; negative framing over 10 years ( the number that will have CVD ) and negative framing per year over 10 years of the effects of antihypertensive medication on the 10-year risk for CVD for a 40 year-old man with newly diagnosed hypertension without other risk factors . Finally , all participants were shown all presentations and detailed patient information about hypertension and were asked to decide again . We calculated a relative importance score ( RIS ) by subtracting the VAS-scores for the undesirable consequences of antihypertensive medication from the VAS-score for the benefit of CVD risk reduction . We used logistic regression to determine the association between participants ' RIS and their choice . 1,528 participants completed the study . The statistically significant differences between the groups in the likelihood of choosing to take antihypertensive medication in relation to different values ( RIS ) increased as the RIS increased . Positively framed information lead to decisions most consistent with those made by everyone for the second , more fully informed decision . There was a statistically significant decrease in deciding to take antihypertensives on the second decision , both within groups and overall . Conclusions For decisions about taking antihypertensive medication for people with a relatively low baseline risk of CVD ( 70 per 1000 over 10 years ) , both positive and negative framing result ed in significantly more people deciding to take medication compared to what participants decided after being shown all three of the presentations . Trial Registration International St and ard R and omised Controlled Trial Number Register IS RCT N OBJECTIVE In the course of performing systematic review s on the prevalence of low back and neck pain , we required a tool to assess the risk of study bias . Our objectives were to ( 1 ) modify an existing checklist and ( 2 ) test the final tool for interrater agreement . STUDY DESIGN AND SETTING The final tool consists of 10 items addressing four domains of bias plus a summary risk of bias assessment . Two research ers tested the interrater agreement of the tool by independently assessing 54 r and omly selected studies . Interrater agreement overall and for each individual item was assessed using the proportion of agreement and Kappa statistic . RESULTS Raters found the tool easy to use , and there was high interrater agreement : overall agreement was 91 % and the Kappa statistic was 0.82 ( 95 % confidence interval : 0.76 , 0.86 ) . Agreement was almost perfect for the individual items on the tool and moderate for the summary assessment . CONCLUSION We have addressed a research gap by modifying and testing a tool to assess risk of study bias . Further research may be useful for assessing the applicability of the tool across different conditions AIMS To discover whether patients have the same expectations of benefit from taking the first and any additional drugs for the treatment of hypertension and to investigate any patient characteristics which predict willingness to take treatment . METHODS This was an anonymous question naire survey carried out in a single primary care group . A r and om sample of patients from the practice list stratified by age and gender were surveyed to determine what benefit they required before deciding to receive first and subsequent drugs to treat hypertension . They were asked to indicate the largest number needing treatment for 5 years ( NNT5 ) to prevent myocardial infa rct ion in 1 ( smallest benefit ) that would persuade them of the need for treatment . Demographic information which might explain variability in enthusiasm for treatment was also collected . RESULTS PARTICIPANTS : required far higher benefit to consider drug treatment than expected with a mean NNT5 for the first treatment of 15.0 ( 95 % CI 12.3 , 17.8 ) . Marginal benefit dem and ed for the addition of second and third treatments was at least as great with an NNT5 of 13.2 ( 95 % CI 10.8 , 15.7 ) and NNT5 of 11.0 ( 95 % CI 8.6 , 13.4 ) . Additional factors influencing willingness to take treatment were gender with a difference in NNT5 between men and women of 7.1 ( 95 % CI 1.7 , 12.5 ) , difficulty in making the decision ( very easy vs very difficult ) of 14.9 ( 95 % CI 6.0 , 23.8 ) , and years in full time education 2.0 ( 95 % CI 0.9 , 3.0 ) for each additional year of education . Any slope of NNT5 with increasing number of tablets disappeared when gender , years in education , and difficulty in reaching a decision were taken into account simultaneously . CONCLUSIONS People may have greater expectation of benefit from antihypertensive drug treatment than it provides . They certainly do not view the addition of subsequent drugs as any lesser step than starting the first in terms of the benefit expected . Full underst and ing of both the risks and benefits may be of critical importance with those spending longer in full time education and those expending more effort in making the decision accepting more treatment . The discrepancy between benefit expected and that available dem and s further research into methods of determining patients ' expectations and informing individual patient decisions Context In previous research , different ways of describing the outcomes of an intervention led to different health care decisions . Contribution Healthy people were r and omly assigned to receive equal but different descriptions of the outcome of a hypothetical intervention to prevent myocardial infa rct ion ( MI ) . Responders were more likely to consent to treatment when the outcome was described as the number needed to treat to prevent 1 MI . They were less likely to consent when the intervention was described as not preventing but delaying an MI by 2 months for all persons or by 8 months for 25 % of persons . Caution The scenarios were presented in a survey and were hypothetical . Implication Quantitatively equal but differently worded outcomes elicit different health care decisions . The Editors Considerable re sources are devoted to drug therapies that are aim ed at modifying risk factors , such as hypertension , elevated cholesterol levels ( 1 ) , and osteoporosis . For individual patients , the choice to begin preventive drug therapy should be consistent with their values and preferences . Thus , to engage meaningfully in shared decision making and to provide truly informed consent , patients need to have a clear underst and ing of the benefits and harms of a treatment . Strong and consistent evidence shows that stated preferences for medical interventions may depend on how the treatment effects are described . For example , the likelihood of choosing a therapy may depend on whether its benefits are presented as absolute risk reductions or relative risk reductions ( 2 ) or as losses versus gains ( 35 ) . These effects suggest the potential for influencing the patient 's response by describing treatment effects in a certain way . We explore laypersons ' responses to different ways of explaining possible outcomes of an intervention . When informing decision makers about the benefit of risk-reducing drug therapies , several authors have advocated using the number needed to treat ( NNT ) to avoid 1 outcome ( 610 ) , which is defined as the reciprocal of the absolute risk reduction . The NNT is the average number of patients in an intervention group who must be treated for a specific period to observe 1 fewer adverse outcome by the end of this period compared with those in a control group . Several authors believe that NNT provides an easily understood way to describe the effort needed to prevent adverse outcomes ( 911 ) . However , for drug therapies aim ed at disease processes that develop slowly , such as atherosclerosis and osteoporosis , the term prevention may be misleading . Rather than completely preventing adverse outcomes in a small fraction of patients , an intervention may postpone the event for many treated patients . Describing the outcome of treatment in terms of postponing an event may be a good alternative to using NNT for helping patients to underst and the potential consequences of a decision . We hypothesized that when laypersons consider preventive drug therapies , they will find the concept of time and , hence , postponementsmore useful than the concept of NNT . Specifically , we tested the hypotheses that laypersons perceive information about postponements as being easier to underst and than the concept of NNT and that the rates at which a person consents to hypothetical drug therapies may depend on the measure that is used to describe the drugs ' effects . Methods Participants In 2002 , as part of regional health surveys in Norway ( 12 , 13 ) , the Norwegian Institute of Public Health invited all inhabitants born in 1925 to 1947 , 1957 , 1962 , and 1972 and all persons born in 1948 to 1968 who had been invited to former screenings in Finnmark County , Norway , to participate in the Troms and Finnmark ( TROFINN ) health study ( 13 ) . For each participant , blood pressure and body mass index were measured and a blood sample was drawn to measure lipids and glucose levels . The participants completed 2 comprehensive question naires that included sociodemographic data ; health-related information ; and habits regarding exercise , food and alcohol consumption , and smoking . Two weeks after screening , the participants received a letter with their results . Participants who were at high risk for cardiovascular disease were advised to contact their general practitioner for follow-up . For our study , we surveyed a sample of participants from the TROFINN study ( who lived in 10 municipalities along the coast of Finnmark ) about their preferences for risk-reducing drug therapies . Figure 1 shows the formation of our study sample . Of the 11284 persons invited to screening , 6854 ( 61 % ) participated , of whom 6445 were eligible for our study . Eligibility was based on the person 's written consent to allow research ers to use data from the initial screening and his or her willingness to be approached about future surveys . We excluded persons who died or emigrated between the initial screening and the date of our survey and those with a missing address . For other study purpose s ( 14 ) , we ranked the participants according to their cardiovascular risk to identify high-risk ( n= 754 ) and low-risk ( n= 1000 ) persons . We surveyed these persons about whether they would use a hypothetical drug aim ed at reducing the risk for a heart attack . We also surveyed a r and om sample of the remaining persons ( n= 1000 ) about whether they would use a hypothetical drug to reduce the risk for hip fracture . To maximize the response rate , we mailed 1 reminder letter and a copy of the question naire to nonresponders . We planned to enroll approximately 1000 persons in each group , but the number of high-risk persons was lower than expected . Figure 1 . Study flow diagram . A total of 2754 attendees to a population -based health study were r and omly assigned to hypothetical scenarios that presented the benefits of preventive drug therapies in terms of number needed to treat ( NNT ) or postponement of adverse events . Eligibility criteria were as follows : attended screening , consented to additional studies , were alive or did not emigrate between the time of the screening and the survey , and had a known address . Strategic allocation to the study groups by risk for cardiovascular disease ( CVD ) was done for other study purpose s , and for similar reasons , the low-risk sample was selected so that the proportion of women was the same as that in the high-risk sample ( 14 ) . We expected to enroll approximately 1000 persons in each risk group , but the number of high-risk persons was lower than expected . Procedures We presented a scenario that described hypothetical drug therapy to prevent a heart attack to persons in 1 group and a scenario that described such therapy to prevent hip fracture to persons in the other group ( Figure 2 ) . Using data from the Sc and inavian Simvastatin Survival Study ( 15 , 16 ) , we calculated the NNT to prevent 1 heart attack after 5 years of therapy ( NNT , 13 ) and the number of participants for whom treatment would postpone a heart attack and the length of the disease-free interval ( a 2-month average postponement for all patients and an 8-month postponement for 1 of 4 patients , with no benefit for 3 of 4 patients ) ( Figure 2 ; Appendix Tables 1 and 2 ) . We used a computerized r and om- sample function ( SPPS , Chicago , Illinois ) to r and omly assign respondents in the high-risk and low-risk groups to 1 of the 3 scenarios ( Figure 1 ) . We also calculated the benefit of hip fracture prevention after 5 years of therapy using data from the Fracture Intervention Trial ( 17 ) . The NNT to prevent 1 hip fracture was 57 . Alternatively , as a result of treatment , all patients would have a hip fracture 16 days later than they would have without treatment or only 3 of 100 patients would have a hip fracture 16 months later than they would have without treatment , whereas the remaining patients would not benefit ( Figure 2 ; Appendix Tables 1 and 2 ) . Again , allocation to the 3 scenarios was r and om . One survey question asked respondents whether they found it very easy , somewhat easy , somewhat difficult , or very difficult to underst and the treatment effect . Another question asked whether the respondent would consent to the hypothetical drug therapy because of the benefits described in the scenario . Possible response categories were certainly , probably , probably not , or certainly not . We linked each respondent 's answers to his or her responses to the health survey given by the Norwegian Institute of Public Health . Figure 2 . The question naire for the heart attack group . In each question naire , only 1 of the 3 versions of item Q1 ( a , b , or c ) was used . The respondents were r and omly allocated to 1 version of the question naire only . We used similar scenarios with different numbers for the hip fracture question naire . Appendix Table 1 . Estimation of Corresponding Magnitudes of Number Needed to Treat and Postponement of Adverse Events after 5 Years of Drug Therapy in the Heart Attack Group * Appendix Table 2 . Estimation of Corresponding Magnitudes of Number Needed to Treat and Postponements of Adverse Events after 5 Years of Drug Therapy in the Hip Fracture Group * Outcome Measures We tested the hypotheses that more respondents would report difficulties in underst and ing the NNT effect format than the 2 postponement formats and that the proportion of respondents who consented to therapy would differ among the 3 scenarios . Therefore , the primary outcome measures were the rates of consent to therapy and the difficulty in underst and ing the effect format . Although the survey provided the respondent with several grade d responses , we dichotomized these variables when we analyzed the survey data . Therefore , we defined difficulty as a response of very difficult or quite difficult . We defined consent as a response of certainly or probably to the question regarding willingness to consent to the therapy . Analysis of these variables as 4-point responses instead of as dichotomous responses yielded similar results , but for ease of underst and ing , we present the results with the BACKGROUND AND OBJECTIVES Reports of r and omized controlled trials ( RCTs ) should set findings within the context of previous research . The result ing network of citations would also provide an alternative search method for clinicians , research ers , and systematic review ers seeking to base decisions on all available evidence . We sought to determine the connectedness of citation networks of RCTs by examining direct ( referenced trials ) and indirect ( through references of referenced trials , etc ) citation of trials to one another . METHODS Meta-analyses were used to create citation networks of RCTs addressing the same clinical questions . The primary measure was the proportion of networks where following citation links between RCTs identifies the complete set of RCTs , forming a single connected citation group . Other measures included the number of disconnected groups ( isl and s ) within each network , the number of citations in the network relative to the maximum possible , and the maximum number of links in the path between two connected trials ( a measure of indirectness of citations ) . RESULTS We included 259 meta-analyses with a total of 2,413 and a median of seven RCTs each . For 46 % ( 118 of 259 ) of networks , the RCTs formed a single connected citation group-one isl and . For the other 54 % of networks , where at least one RCT group was not cited by others , 39 % had two citation isl and s and 4 % ( 10 of 257 ) had 10 or more isl and s. On average , the citation networks had 38 % of the possible citations to other trials ( if each trial had cited all earlier trials ) . The number of citation isl and s and the maximum number of citation links increased with increasing numbers of trials in the network . CONCLUSION Available evidence to answer a clinical question may be identified by using network citations created with a small initial corpus of eligible trials . However , the number of isl and s means that citation networks can not be relied on for evidence retrieval BACKGROUND Hypertension guidelines from different organizations often specify different treatment thresholds , and none explicitly state how these thresholds were chosen . This study was undertaken to determine the treatment thresholds of family physicians and hypertensive patients for mild , uncomplicated essential hypertension . A subject 's treatment threshold can be determined by eliciting the minimum reduction in cardiovascular risk that he or she feels outweighs the inconvenience , costs and side effects of antihypertensive therapy ( the minimal clinical ly important difference [ MCID ] ) . METHODS The study subjects consisted of a r and om sample of family physicians and a consecutive sample of hypertensive patients without overt cardiovascular disease from Ottawa and Edmonton . To determine participants ' MCIDs , we used a survey employing hypothetical scenarios ( each depicting a different baseline cardiovascular risk ) and a probability trade-off tool . RESULTS Of 94 family physicians and 146 patients approached for the study , 72 and 74 participated respectively . There was marked variability in the MCIDs of both groups . In general , patients were less likely to want antihypertensive therapy than physicians , particularly when baseline cardiovascular risks were low : 49 % v. 64 % ( p = 0.06 ) , 68 % v. 92 % ( p < 0.001 ) and 86 % v. 100 % ( p = 0.001 ) for 5-year cardiovascular risks of 2 % , 5 % and 10 % respectively . Moreover , patients expressed larger MCIDs ( i.e. , wanted greater benefits before accepting therapy ) than physicians . However , a subgroup of patients ( 15 % to 26 % , depending on the scenario ) wanted treatment even if there was no anticipated benefit . Multivariate analysis showed that no sociodemographic factors strongly predicted the MCIDs of either group . INTERPRETATION Guidelines that set treatment thresholds on the basis of physician or expert opinion may not accurately reflect the preferences of hypertensive patients . There is a need for patient decision aids and attention to patient preferences when initiation of antihypertensive therapy is considered for the prevention of cardiovascular disease . Further research is needed to define treatment thresholds for other chronic conditions and in other groups This issue of JAMA contains the latest US Preventive Services Task Force ( USPSTF ) recommendation statement on statins for prevention of cardiovascular disease in adults,1 along with the accompanying evidence report and systematic review 2 on which the recommendations are based . The evidence report summarized data from 19 trials including a total of 71 344 patients and concluded that statin therapy was associated with reduced risk of all-cause and cardiovascular mortality and cardiovascular disease ( CVD ) events . Thus , the task force recommended “ initiating use of lowto moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 10 % or greater ( B recommendation ) ” or “ 7.5 % to 10 % ( C recommendation ) .”1 Although the task force did their usual careful job of review ing the evidence , the evidence for treating asymptomatic persons with statins does not appear to merit a grade B or even a grade C recommendation . The task force evidence report estimated an absolute benefit for use of statins of 0.40 % for all-cause mortality and 0.43 % for cardiovascular mortality and indicated that the absolute benefit was greater for patients at greater baseline risk.2 Notably , the evidence report did not exclude studies that included patients taking statins for secondary prevention , who have a higher baseline risk of cardiac events and death and thus are more likely to benefit from therapy that inflates the benefit attributed to a primary prevention population . The task force did perform a sensitivity analysis that excluded 3 trials with persons for whom there were prior “ hard ” cardiovascular events and obtained similar results of benefits ( eTable 5 in the article by Chou et al2 ) . This sensitivity analysis did not exclude WOSCOPS , which included patients receiving statins for secondary prevention—5 % had angina and 3 % had intermittent claudication,3 accounting for 15 % of the total weight in the meta- analysis . In contrast , a meta- analysis of 11 studies and 65 229 patients receiving statins for primary prevention , in which patients receiving statins for secondary prevention were excluded , found no benefit of statins for reducing all-cause mortality.4 The confidence intervals of these 2 analyses overlap , and the difference between these findings likely reflects differences in studies included . The USPSTF and authors of the evidence report did not have access to the primary data ( clinical study reports and anonymized patient-level data ) from the statin clinical trials . Rather , they had to rely on peer- review ed published reports as the basis for these recommendations . Exacerbating the potential bias , all of the trials included in the task force evidence report2 were industry-sponsored except 1 trial,5 and that trial contributed 0.2 % of the weight to the mortality calculation . Industry-sponsored studies have been shown to report greater benefit and lesser adverse effects than noncommercially sponsored trials of the same drugs.6 Whether this is true for statins and primary prevention of CVD is unknown . Among the 19 r and omized clinical trials of statins vs placebo or no statin included in the evidence report for the task force recommendations , only 15 reported all-cause mortality , 10 reported cardiovascular mortality , 12 reported fatal and nonfatal myocardial infa rct ion , and 13 reported fatal and nonfatal stroke.2,7 Reliance on selective reporting of the most important outcomes , which are likely included in the clinical trial data , makes reporting bias possible . Furthermore , after allcause mortality , the comparative incidence of serious adverse events between treatment and control groups is arguably the second most important measure of the effect of active therapy in r and omized clinical trials . Underst and ing the evidence base in evaluating harms of statin therapy is also critically important . Although the benefits of any preventive therapy accrue according to risk of disease ( greater benefit in higher-risk patients ) , the harms of therapy usually distribute equally over all risk levels . Thus , persons at low risk have little chance of benefit but equal chance of harms and thus are more likely to have a net harm . The evidence base for harms of statins , despite the introduction of these drugs more than 20 years ago , is incomplete . Many of the trials did not ask about commonly reported statin effects , such as muscle pains and weakness , and only recorded myopathy , for which an increase in creatine kinase levels was required . Because most muscle problems do not involve an increase in creatine kinase levels , this leads to a significant underestimate of muscle problems . Other studies have estimated that closer to 20 % of statin users have muscle problems.8 Additionally , the actual trial data are largely held by the Cholesterol Treatment Trialists ’ Collaboration on behalf of the industry sponsor and have not been made available to other research ers , despite multiple requests over many years.9 Although reported rates of adverse events in clinical trials are low , this does not reflect the experience of clinicians who see patients who are taking statins . For instance , the experience of an NPR reporter with a calculated 2.9 % risk of heart disease over 10 years using the recommended American College of Cardiology/American Heart Association ( ACC/AHA ) risk calculator,10 but still prescribed a statin , and experiencing adverse effects from the medication , is typical of what many Related articles at jama.com BACKGROUND The number needed to treat ( NNT ) has been widely recommended for communicating benefits from risk reductions . It has been cl aim ed that NNT is easily understood and that it has intuitive meaning . There are , however , only few studies of lay people 's underst and ing of NNT . OBJECTIVE The objective of this study was to explore whether lay people are sensitive to the magnitude of treatment effectiveness as expressed in terms of NNT , and whether the sensitivity is influenced by variation in the type of health outcome , variation in patients ' payment for the treatment or variation in the type of side effects . METHODS In total , 2326 non-institutionalized Danes aged 18 - 91 years were interviewed face to face and asked whether they would consent to a treatment against a somewhat increased risk of death or heart attack . The respondents were allocated to different levels of effectiveness of treatment expressed as NNT of 10 , 100 , 200 or 400 , different costs and different descriptions of adverse effects . RESULTS The odds for consenting to therapy were little influenced by the magnitude of NNT , but were greater among married respondents and among those who had side effects presented in terms of headache and constipation . CONCLUSION In this study , the respondents ' choice of treatment was largely insensitive to the magnitude of NNT independently of variations in type of health outcome and costs . NNT may not be easily understood by lay people Background — Primary prevention guidelines focus on risk , often assuming negligible aversion to medication , yet most patients discontinue primary prevention statins within 3 years . We quantify real-world distribution of medication disutility and separately calculate the average utilities for a range of risk strata . Method and Results — We r and omly sample d 360 members of the general public in London . Medication aversion was quantified as the gain in lifespan required by each individual to offset the inconvenience ( disutility ) of taking an idealized daily preventative tablet . In parallel , we constructed tables of expected gain in lifespan ( utility ) from initiating statin therapy for each age group , sex , and cardiovascular risk profile in the population . This allowed comparison of the widths of the distributions of medication disutility and of group-average expectation of longevity gain . Observed medication disutility ranged from 1 day to > 10 years of life being required by subjects ( median , 6 months ; interquartile range , 1–36 months ) to make daily preventative therapy worthwhile . Average expected longevity benefit from statins at ages ≥50 years ranges from 3.6 months ( low-risk women ) to 24.3 months ( high-risk men ) . Conclusion — We can no longer assume that medication disutility is almost zero . Over one-quarter of subjects had disutility exceeding the group-average longevity gain from statins expected even for the highest-risk ( ie , highest-gain ) group . Future primary prevention studies might explore medication disutility in larger population s. Patients may differ more in disutility than in prospect ively definable utility ( which provides only group-average estimates ) . Consultations could be enriched by assessing disutility and exploring its reasons |
1,304 | 19,226,524 | Sensitivities of the full domain measures were universally high , but information about their specificity against psychiatric and non-progressive neurological conditions and predictive validity is lacking .
Several cognitive screening instruments afford the clinician the ability to detect MCI , early AD , and in some cases non-AD dementia , but they can not currently be used to make reliable inferences about the course and eventual outcome of MCI | OBJECTIVE Patients with mild cognitive impairment account for a significant number of referrals to old age psychiatry services and specialist memory clinics .
The cognitive evaluation of such patients is commonly restricted to brief dementia screens , with no consideration to their suitability for assessing MCI .
Here , we review the utility of such cognitive screens for MCI and provide an overview of vali date d instruments . | Objective : To develop a short cognitive test for screening mild cognitive impairment ( MCI ) in Hong Kong Chinese older adults . Methods : The Chinese Abbreviated MCI ( CAMCI ) test was developed with a multistage process . In phase 1 , a short version of the cognitive test comprising a 1-min animal fluency test and a 10-min delayed word list recall was developed and tested in 578 volunteers ( community-dwelling active elderly persons ) . In phase 2 , the CAMCI test was vali date d in an independent and r and omly recruited sample of 459 participants in a community survey . Additionally , the predictive significance of the CAMCI test was evaluated in a group of 196 subjects assessed in phase 1 for conversion to clinical dementia at 20 months ’ follow-up . The discriminating power of the CAMCI test in differentiating MCI from normal control ( NC ) and mildly demented subjects was compared with Mini Mental State Examination ( MMSE ) and Alzheimer ’s Disease Assessment Scale-Cognitive ( ADAS-Cog ) subscales . Results : The CAMCI test was found to have high discriminating power in differentiating NC from MCI and mildly demented subjects in the phase 1 volunteer sample . The receiver operating characteristics ( ROC ) revealed an area under the curve ( AUC ) of 0.91 . The ROC were further vali date d in the phase 2 sample . The AUC of the CAMCI test was compared with MMSE and ADAS-Cog subscales . The short MCI test was comparable to the ADAS-Cog subscale in discriminating NC from MCI and demented subjects ( χ2 test , p = n.s . ) . Logistic regression analysis was carried out to determine significant baseline predictors for conversion to dementia at phase 3 follow-up . Both ADAS-Cog total [ Exp(B ) = 1.115 , p = 0.028 ] and CAMCI [ Exp(B ) = 0.88 , p = 0.045 ] scores were significant predictors for dementia status at follow-up . Conclusion : The CAMCI test is able to discriminate NC from MCI and mild dementia in Hong Kong Chinese older adults . Its potential for large-scale community screening for early detection of cognitive impairment in late life should be emphasized and explored Background / Aims : To prospect ively follow up a group of amnesic patients at risk for Alzheimer ’s disease ( AD ) , to characterize a group of patients whose features were intermediate between amnesic mild cognitive impairment ( aMCI ) and probable AD , prodromal AD ( Prd-AD ) , and to investigate if these patients were at higher risk for AD conversion . Methods : A total of 109 subjects were assessed by neuropsychological evaluation and by 1H magnetic resonance spectroscopy ( 1H-MRS ) : 27 controls , and 16 aMCI , 34 probable AD and 32 Prd-AD patients . Results : Episodic memory and frontal test scores result ed lower in Prd-AD compared to aMCI patients . Prd-AD patients obtained significantly higher scores than AD ones in language , perception , praxis and frontal functions . Although Prd-AD and AD patients had distinct 1H-MRS features from aMCI ones , there were no 1H-MRS differences between Prd-AD and AD patients . The AD annual conversion rate after 1 year of follow-up for Prd-AD ( 57.1 % ) was higher than in aMCI patients ( 20 % ; p < 0.01 ) . A logistic regression , in which all amnesic patients were treated as a single group , showed that the Visual Memory Test was a significant neuropsychological predictor for AD conversion . Conclusions : Prd-AD patients are a clinical ly distinguishable group , with distinct neuropsychological and 1H-MRS features and a higher conversion rate to probable AD than aMCI patients BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions Background : Magnetic resonance diffusion tensor imaging ( DTI ) shows promise in the early detection of microstructural pathophysiological changes in the brain . Objectives : To measure microstructural differences in the brains of participants with amnestic mild cognitive impairment ( MCI ) compared with an age-matched control group using an optimised DTI technique with fully automated image analysis tools and to investigate the correlation between diffusivity measurements and neuropsychological performance scores across groups . Methods : 34 participants ( 17 participants with MCI , 17 healthy elderly adults ) underwent magnetic resonance imaging (MRI)-based DTI . To control for the effects of anatomical variation , diffusion images of all participants were registered to st and ard anatomical space . Significant statistical differences in diffusivity measurements between the two groups were determined on a pixel-by-pixel basis using gaussian r and om field theory . Results : Significantly raised mean diffusivity measurements ( p<0.001 ) were observed in the left and right entorhinal cortices ( BA28 ) , posterior occipital – parietal cortex ( BA18 and BA19 ) , right parietal supramarginal gyrus ( BA40 ) and right frontal pre central gyri ( BA4 and BA6 ) in participants with MCI . With respect to fractional anisotropy , participants with MCI had significantly reduced measurements ( p<0.001 ) in the limbic parahippocampal subgyral white matter , right thalamus and left posterior cingulate . Pearson ’s correlation coefficients calculated across all participants showed significant correlations between neuropsychological assessment scores and regional measurements of mean diffusivity and fractional anisotropy . Conclusions : DTI-based diffusivity measures may offer a sensitive method of detecting subtle microstructural brain changes associated with pre clinical Alzheimer ’s disease Summary OBJECTIVE : The goals of this study were to determine the annual conversion rate to Alzheimer disease ( AD ) among patients reporting memory problems , including a subgroup with amnestic mild cognitive impairment ( aMCI ) , and to investigate the predictive value of neurocognitive testing for future dementia . METHODS : A prospect i ve study was carried out in an outpatient memory clinic . One hundred and seven patients underwent a clinical examination and completed a battery of st and ard cognitive tests at study entry and two years later . The conversion rate to clinical ly manifested AD two years later was investigated , and sensitivity , specificity , receiver operating characteristics ( AUC ) , positive predictive value and negative predictive value for each neuropsychological test were determined . RESULTS : We found an annual rate of conversion to AD of 6.5 % among patients reporting memory decline in the setting of our clinic . Specifically , patients with aMCI had an annual conversion rate of approximately 20 % . The annual conversion rate for patients reporting memory problems but showing no memory deficit at memory testing was approximately 3 % . Receiver operating characteristics ( AUC ) of the neuropsychological tests ranged from 0.60 to 0.94 . CONCLUSIONS : Patients with aMCI have 8.6-fold higher odds of developing AD compared with patients without evident memory impairment on neuropsychological testing . Although the risk of developing AD among patients without objective memory decline is small , some patients in this group still convert to AD , and therefore , close clinical monitoring of patients is necessary . ZusammenfassungZIEL : Ziel der vorliegenden Studie war die Bestimmung der jährlichen Konversionsrate von Patienten mit subjektiver Gedächtnisbeeinträchtigung zur Alzheimerkrankheit unter Berücksichtigung der amnestischen Milden Kognitiven Störung ( aMCI ) . Die Wertigkeit zur Vorhersage der Konversion durch einzelne neuropsychologische Testverfahren wurde ebenfalls untersucht . METHOD IK : I m Rahmen einer Gedächtnisambulanz wurde eine prospektive Studie durchgeführt . 107 Patienten wurden in die Studie inkludiert . Alle Patienten durchliefen eine neurologische und eine neuropsychologische Untersuchung am Beginn der Studie und nach zwei Jahren am Ende der Studie . Einerseits wurde die Konversionsrate zur Alzheimerkrankheit untersucht , und and erseits wurden einige Kennwerte der Kriteriumsvalidität ( Sensitivität , Spezifität , Receiver Operating Characteristics [ AUC ] , Positive Predictive Value , Negative Predictive Value ) einzelner neuropsychologischer Testverfahren zur Vorhersage der Alzheimerkrankheit bestimmt . RESULT AT : Wir f and en eine jährliche Konversionsrate von 6,5 % für Patienten , die eine Beeinträchtigung der Gedächtnisfunktionen berichteten . Patienten mit aMCI hatten eine jährliche Konversionsrate von ungefähr 20 % . Die jährliche Konversionsrate von Patienten mit subjektiver Gedächtnisbeeinträchtigung ohne testpsychologisch nachweisbare Gedächtnistörung lag bei ungefähr 3 % . Receiver operating characteristics ( AUC ) für einzelne neuropsychologische Verfahren lagen zwischen 0,60 und 0,94 . KONKLUSION : Patienten mit aMCI haben , i m Vergleich zu Patienten ohne neuropsychologisch fassbare Gedächtnisstörung , eine 8,6-fache Wahrscheinlichkeit , innerhalb von zwei Jahren eine klinisch manifeste Alzheimerkrankheit zu entwickeln . Obwohl die Wahrscheinlichkeit für Patienten ohne neuropsychologisch fassbare Gedächtnisstörung , innerhalb von zwei Jahren eine Alzheimerkrankheit zu entwickeln , gering ist , konvertieren einige wenige Patienten doch zur Alzheimerkrankheit . Engmaschige Kontrolluntersuchungen sind deshalb notwendig Objective . To design a brief cognitive screener with acceptable sensitivity and specificity for identifying subjects with cognitive impairment Design . Cohort one is assembled from a community-based survey coupled with a second-stage diagnostic evaluation using formal diagnostic criteria for dementia . Cohort two is assembled from referrals to a specialty clinic for dementing disorders that completed the same diagnostic evaluation . Setting . Urban neighborhoods in Indianapolis , Indiana and the Indiana Alzheimer Disease Center . Patients . Cohort one consists of 344 community-dwelling black persons identified from a r and om sample of 2212 black persons aged 65 and older residing in Indianapolis ; cohort two consists of 651 subject referrals to the Alzheimer Disease Center . Measurements . Formal diagnostic clinical assessment s for dementia including scores on the Mini-mental state examination ( MMSE ) , a six-item screener derived from the MMSE , the Blessed Dementia Rating Scale ( BDRS ) , and the Word List Recall . Based on clinical evaluations , subjects were categorized as no cognitive impairment , cognitive impairment-not demented , or demented . Results . The mean age of the community-based sample was 74.4 years , 59.4 % of the sample were women , and the mean years of education was 10.1 . The prevalence of dementia in this sample was 4.3 % and the prevalence of cognitive impairment was 24.6 % . Using a cut-off of three or more errors , the sensitivity and specificity of the six-item screener for a diagnosis of dementia was 88.7 and 88.0 , respectively . In the same sample , the corresponding sensitivity and specificity for the MMSE using a cut-off score of 23 was 95.2 and 86.7 . The performance of the two scales was comparable across the two population s studied and using either cognitive impairment or dementia as the gold st and ard . An increasing number of errors on the six-item screener is highly correlated with poorer scores on longer measures of cognitive impairment . Conclusions . The six-item screener is a brief and reliable instrument for identifying subjects with cognitive impairment and its diagnostic properties are comparable to the full MMSE . It can be administered by telephone or face-to-face interview and is easily scored by a simple summation of errors BACKGROUND Mild cognitive impairment ( MCI ) is considered to be a transitional stage between aging and Alzheimer disease ( AD ) . OBJECTIVE To determine whether MCI represents early-stage AD by examining its natural history and neuropathologic basis . DESIGN A prospect i ve clinical and psychometric study of community-living elderly volunteers , both nondemented and minimally cognitively impaired , followed up for up to 9.5 years . Neuropathologic examinations were performed on participants who had undergone autopsy . SETTING An AD research center . PARTICIPANTS All participants enrolled between July 1990 and June 1997 with Clinical Dementia Rating ( CDR ) scores of 0 ( cognitively healthy ; n = 177 ; mean age , 78.9 years ) or 0.5 ( equivalent to MCI ; n = 277 ; mean age , 76.9 years ) . Based on the degree of clinical confidence that MCI represented dementia of the Alzheimer type ( DAT ) , 3 subgroups of individuals with CDR scores of 0.5 were identified : CDR 0.5/DAT , CDR 0.5/incipient DAT , and CDR 0.5/uncertain dementia . MAIN OUTCOME MEASURE Progression to the stage of CDR 1 , which characterizes mild definite DAT . RESULTS Survival analysis showed that 100 % of CDR 0.5/DAT participants progressed to greater dementia severity over a 9.5-year period . At 5 years , rates of progression to a score of CDR 1 ( or greater ) for DAT were 60.5 % ( 95 % confidence interval [ CI ] , 50.2%-70.8 % ) for the CDR 0.5/DAT group , 35.7 % ( 95 % CI , 21.0%-50.3 % ) for the CDR 0.5/incipient DAT group , 19.9 % ( 95 % CI , 8.0%-31.8 % ) for the CDR 0.5/uncertain dementia group , and 6.8 % ( 95 % CI , 2.2%-11.3 % ) for CDR 0/controls . Progression to greater dementia severity correlated with degree of cognitive impairment at baseline . Twenty-four of the 25 participants with scores of CDR 0.5 had a neuropathologic dementing disorder , which was AD in 21 ( 84 % ) . CONCLUSIONS Individuals currently characterized as having MCI progress steadily to greater stages of dementia severity at rates dependent on the level of cognitive impairment at entry and they almost always have the neuropathologic features of AD . We conclude that MCI generally represents early-stage AD BACKGROUND Mild cognitive impairment ( MCI ) represents a transitional state between the cognitive changes of normal aging and very early dementia and is becoming increasingly recognized as a risk factor for Alzheimer disease ( AD ) . The Memory Impairment Study ( MIS ) is a multicenter clinical trial in patients with MCI design ed to evaluate whether vitamin E or donepezil is effective at delaying the time to a clinical diagnosis of AD . OBJECTIVE To describe the baseline characteristics of patients with MCI recruited for the MIS and compare them with those of elderly controls and patients with AD in another clinical trial . DESIGN Descriptive and comparative study of patients with MCI participating in a multicenter clinical trial . SETTING Memory disorder centers in the United States and Canada . PATIENTS A total of 769 patients with MCI , 107 cognitively normal elderly controls , 122 patients with very mild AD ( Clinical Dementia Rating [ CDR ] 0.5 ) , and 183 patients with mild AD ( CDR 1.0 ) were evaluated . Patients in the MIS met operational criteria for amnestic MCI . Controls were recruited in parallel with the MCI group , underwent the same assessment s , and had a CDR of 0 . MAIN OUTCOME MEASURES Clinical , neuropsychologic , functional , neuroimaging , and genetic measures . RESULTS Mean + /- SD Alzheimer 's Disease Assessment Scale-Cognitive Subscale scores were 5.6 + /- 3.3 for controls , 11.3 + /- 4.4 for patients with MCI , 18.0 + /- 6.2 for the AD CDR 0.5 group , and 25.2 + /- 8.8 for the AD CDR 1.0 group . Compared with controls , patients with MCI were most impaired on memory tasks , with less severe impairments in other cognitive domains . Patients with MCI were more likely than controls but less likely than patients with AD to carry the apolipoprotein E epsilon4 allele . Patients with MCI had hippocampal volumes that were intermediate between those of controls and patients with AD . CONCLUSIONS Patients with MCI had a predominant memory impairment with relative sparing of other cognitive domains and were intermediate between clinical ly normal individuals and patients with AD on cognitive and functional ratings . These results demonstrate the successful implementation of operational criteria for this unique group of at-risk patients in a multicenter clinical trial Objective : To compare the sensitivity and specificity of the AB Cognitive Screen ( ABCS ) with the St and ardized Mini-Mental State Examination ( SMMSE ) to differentiate normal cognition from mild cognitive impairment ( MCI ) , especially when educational level and age are taken into account . Method : This cross-sectional study took place at geriatric outpatient memory clinics . Participants were community-dwelling adults , aged 55 years or over , referred from primary care setting s ( a minority of participants were referred from specialists ) for assessment of memory loss and age-matched control subjects with no complaint of memory loss . Each participant had the ABCS and the SMMSE administered in r and om order on the same day . Results : Participants included 124 patients diagnosed with MCI and 111 with normal cognitive function . The ABCS showed a statistically significant difference between normal cognition and MCI ( ABCS score 111.7 and 104.6 points , respectively , P < 0.001 ) for the whole group . This difference was significant with the ABCS , regardless of participants ' age or education . There was a significant difference between normal cognition and MCI for SMMSE scores ( SMMSE score 27.8 and 27.2 points , respectively , P = 0.040 ) , but the differences were not significant when age and education were taken into account . Age and education were shown to affect the scores of both instruments except for the ABCS scores of MCI subjects , which were not significantly affected by education ( P = 0.059 ) . Conclusions : The ABCS is more sensitive than the SMMSE in differentiating normal cognition from MCI . The ABCS appears to be less influenced by education . It has improved clinical utility with a wider range of scoring gradations , reduced ceiling effects , and shorter scoring and administration times Early identification of dementia and possible risk factors is a critical issue . The Basic Italian Cognitive Question naire ( BICQ ) is design ed as a routine instrument for screening patients with initial cognitive impairment in daily practice . It is devoted to the general physician who needs a tool for deciding whether a subject deserves further diagnostic investigation in specialised centres . The administration of BICQ is easy , fast and does not require any training , since it is composed of 12 simple and ecologic questions referring to daily life . The discriminant analysis , a predictive model that generates a function based on linear combinations of the predictor variables , provided the best discrimination between controls with respect to the group of deteriorated patients . According to the classification function coefficients , the question naire score predicted correctly 100 % of normal subjects and 85 % of patients with cognitive impairment . Moreover , the receiving operating characteristics ( ROC ) analysis showed that the highest sensitivity and specificity were obtained at the cut-off value of 10 . Thus , a < or=10 score was indicative of a possible cognitive impairment requiring further diagnostic work-up . Among 963 r and omly selected subjects from the general population over 50 years of age , 130 subjects ( 13.5 % ) had a score < or=10 . A complete diagnostic assessment was carried out in 103 of them . Forty-one ( 40 % ) result ed cognitively normal ; 34 ( 33 % ) fulfilled the diagnostic criteria for mild cognitive impairment ( MCI ) ; 28 ( 27 % ) were diagnosed as demented The current increase in aged individuals in number and proportionof the general population warrants dependable strategies to improve early detection of cognitive impairment . It was the goal of the present study to develop a triage for bedside testing and outpatient ser vices . In a prospect i ve clinical cohort study at the outpatient Memory Clinic , University of Ulm , Germany , 232 subjects were diagnosed with Alzheimer ’s disease [ AD ; NINCDS-ADRDA criteria ; n = 66 ; age 65.9 ± 7.3 years ( mean ± SD ) ; Mini Mental State Examination ( MMSE ) score 23.4 ± 4.1 ] , mild cognitive impairment ( MCI ; criteria of Petersen et al. ; n = 48 ; age 66.4 ± 7.1 years ; MMSE score 28.3 ± 1.5 ) , and major depressive disorder ( DSM-IV criteria ; n = 61 ; age 63.4 ± 8.0 years ; MMSE score 28.6 ± 1.6 ) . Diagnosis was secured with extensive neuropsychological , clinical , radiological , and laboratory investigations . Six brief screening tests including the Memory Impairment Screen ( MIS ) , Letter Sorting Test ( LST ) , Verbal Fluency ( VF ) , and Clock Drawing Test ( CDT ) were assessed independently from the diagnostic procedure . We compared single items and composite scores . LST yielded a diagnostic accuracy of 0.81 and 0.62 for AD and MCI patients versus controls , respectively . With the MIS , diagnostic accuracy was 0.89 and 0.71 , respectively . With a combination of LST , MIS , VF , and CDT , a sensitivity for AD and MCI patients of 1.00 and 0.83 was achieved . Thus , single-item screening ( e.g. LST , VF ) taking little more than 1 min and suitable for bedside testing or brief screening in the general practitioner ’s office yields diagnostic accuracy comparable to st and ard laboratory tests for other diseases . A composite of screening tests suitable for application in general outpatient care in neurological and psychiatric services reliably detects patients with AD and MCI PROBLEM Dementia is a significant public health problem that is underrecognized in primary care setting s. This study examined the usefulness of 3 brief screening tests in detecting dementia and mild cognitive impairment ( MCI ) in persons seeking consultation for memory complaints within a network of memory diagnostic clinics in Wisconsin . METHODS This prospect i ve study of consecutive referrals for memory diagnostic evaluation analyzed data for 364 patients > or = 50 years . Scores on 3 cognitive screening measures -the Mini-Mental State Examination ( MMSE ) , Clock Drawing , and Animal Naming -- were compared to clinical diagnosis of normal cognitive aging , MCI , or dementia . RESULTS Using the st and ard cut score of < 24 , the MMSE identified only 60 % of persons diagnosed with dementia . By contrast , using a recommended cut score of < 14 words per minute , Animal Naming identified 85 % of persons with dementia with a relatively low ( 12 % ) false positive rate . Clock Drawing was intermediate to the other 2 measures in screening effectiveness . CONCLUSIONS Animal Naming was moderately to highly effective in identifying dementia . The naming procedure is easy to administer and may have value as a brief initial dementia screen in busy practice setting s. More dem and ing cognitive measures may be needed to improve screening accuracy for MCI |
1,305 | 11,034,749 | Both trials reported that not wearing compression hosiery was strongly associated with ulcer recurrence and this is circumstantial evidence that compression reduces ulcer recurrence .
This is circumstantial evidence of the benefit of compression in reducing recurrence .
Recurrence rates may be lower in high compression hosiery than in medium compression hosiery and therefore patients should be offered the strongest compression with which they can comply . | BACKGROUND Up to 1 % of adults will suffer from leg ulceration at some time .
The majority of leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or weakness of the valves in the veins of the leg .
Prevention and treatment of venous ulcers is aim ed at reducing the pressure either by removing / repairing the veins , or by applying compression b and ages / stockings to reduce the pressure in the veins .
The vast majority of venous ulcers are healed using compression b and ages .
Once healed they often recur and so it is customary to continue applying compression in the form of b and ages , tights , stockings or socks in order to prevent recurrence .
Compression b and ages or hosiery ( tights , stockings , socks ) are often applied for ulcer prevention .
OBJECTIVES To assess the effects of compression hosiery ( socks , stockings , tights ) or b and ages in preventing the recurrence of venous ulcers .
To determine whether there is an optimum pressure/type of compression to prevent recurrence of venous ulcers . | This study compared the rate of leg ulcer recurrence using two types of compression stockings and examined the factors underlying Patients with recently healed leg ulceration were entered into a study of leg ulcer recurrence . In all , 188 patients [ 69 % women , mean age = 72 ( SD = 12 ) years ] were entered into the study , of whom 166 were considered suitable for ready-made stockings and were r and omized to one of two class II below-knee compression stockings and followed for at least 18 months . The remaining patients required either made-to-measure stockings ( 5 ) or could not tolerate stockings owing to friable skin and were treated by other methods ( 17 ) . Overall cumulative recurrence rate was 26 % after 1 year and 31 % at 18 months . Independent risk factors for ( RR = 2.34 , p = 0.021 ) and unsuitability for stockings ( RR = 2.52 , p = 0.013 ) . The r and omized groups had similar stockings , 25 ( 15 % ) could not put their stockings on at all and 43 ( 26 % ) were only able to put them on with great difficulty . The two stocking types differed significantly in this regard when analysed for trend The effect of elastic compression on venous flow in the legs provided by carefully fitted stockings has been measured by a venographic technic . The stocking used provides a gradually decreasing compression from ankle to groin . Clearance of stagnant blood from behind venous valves is clearly improved and the differences observed are statistically highly significant . These data suggest that the routine use of carefully fitted compression stockings will result in a decreased incidence of deep vein thrombosis ( DVT ) and provide a singularly safe , convenient , and noninvasive method of prophylaxis . Evidence presented suggests that at least two investigators have failed to show a decreased incidence of DVT in limbs subjected to elastic compression because the method of compression was inadequate |
1,306 | 26,038,611 | Whole body vibration led to significant improvements in functional exercise capacity measured with six minutes walking test .
Nearly no adverse events were observed .
Conclusion : Whole body vibration may improve functional exercise capacity and quality of life in people with chronic obstructive pulmonary disease .
There was insufficient evidence to prove the effects of whole body vibration on pulmonary function | Objective : To examine the effect of whole-body vibration in enhancing pulmonary function , functional exercise capacity and quality of life in people with chronic obstructive pulmonary disease and examine its safety . | Background Benefits of community-based whole-body vibration ( WBV ) as a mode of exercise training for people with chronic obstructive pulmonary disease ( COPD ) have not been investigated . The low skill dem and of WBV may enhance habitual sustainability to physical activity by people with COPD , provided efficacy of WBV can be established . The purpose of this trial was to compare a community-based WBV intervention with a sham WBV ( SWBV ) intervention and monitor exacerbations , exercise tolerance , and functional performance of the lower limbs of people with COPD . Methods Community-dwelling adults with a GOLD clinical diagnosis of COPD were recruited to the trial . This was a Phase II efficacy trial with crossover to sham intervention interspersed with two-week washout . Each six-week intervention consisted of two sessions per week of either WBV or SWBV . The interventions were completed in the home of each participant under supervision . The outcome measures were selected psychological ( perceived dyspnoea ) and physiological ( heart rate and oxygen saturation ) responses to exercise , simulated activities of daily living ( timed-up- and got test and 5-chair st and s test ) , and selected kinematic variables of gait across the 14-week trial . Results Sixteen adults with stable COPD were recruited to the trial . No exacerbations were reported during the WBV or SWBV interventions . After WBV , performance of activities of daily living ( ADLs ) and gait improved ( p ≤ 0.05 ) , while there was no change after SWBV ( p > 0.05 ) . Despite five withdrawals during the washout period , a 100 % compliance to each six-week intervention was noted . Conclusions Results showed that WBV did not exacerbate symptoms of COPD that can be associated with physical inactivity . The WBV intervention improved tests to simulate ADLs such as rising from a chair , turning , and walking gait with greater effect than a SWBV intervention . If a placebo effect was systemic to the WBV intervention , the effect was negligible . As a st and alone community-based intervention , WBV was an efficacious mode of exercise training for people with stable COPD that did not negatively effect exercise tolerance or exacerbate the disease , while concurrently improving functional performance of the lower limbs . Trial registration Australian and New Zeal and Clinical Trials Registry ACTRN12612000508875 Background Exercise intolerance is a common development in patients with chronic obstructive pulmonary disease ( COPD ) . There is little data on the use of an isolated program using vibration platform training on functional capacity in these patients , which is an area that deserves investigation . Aim To investigate the effect of training on a vibrating platform ( whole-body vibration [ WBV ] ) on functional performance and quality of life of subjects with COPD . Methods A r and omized controlled crossover pilot study with eleven subjects with COPD ( forced expiratory volume in 1 second [FEV1]% predicted = 14.63±11.14 ; forced vital capacity [FVC]% predicted = 48.84±15.21 ; FEV1/FVC = 47.39±11.63 ) underwent a 12-week WBV training program . Participants were r and omized into the intervention group ( IG ) undergoing three sessions per week for a total of 12 weeks and control group ( CG ) without intervention . We evaluated the 6-minute walk test ( 6MWT ) , distance walked ( DW ) , duration of the walk ( TW ) , and index of perceived exertion ( IPE ) , quality of life using St George ’s Respiratory Question naire ( SGRQ ) and developed a 12-week program of training on a vibrating platform . Results The mean age was 62.91±8.82 years old ( 72.7 % male ) . The DW increased at the end of training with a difference between groups of 75 m ; all domains of the SGRQ improved at the end of training . The effect size Cohen ’s d ranged from small to large for all the measured results . Conclusion These preliminary results suggest that WBV may potentially be a safe and feasible way to improve functional capacity in the 6MWT of patients with COPD undergoing a training program on the vibrating platform as well as in all domains of the SGRQ quality of life . However , further studies with a larger number of patients are needed to establish the long-term effect on functional capacity and quality of life in these patients Background The potential of whole-body vibration ( WBV ) as a mode of dyspnoea free physical activity for people with chronic obstructive pulmonary disease ( COPD ) is unknown among community-based setting s. Furthermore , the acute effects of WBV on people with COPD have not been profiled in community-based setting s. The aim of this community-based proof-of-concept trial was to describe acute effects of WBV by profiling subjective and objective responses to physical activity . Findings Seventeen community-dwelling older adults with COPD were recruited to participate in two sessions ; WBV and sham WBV ( SWBV ) . Each session consisted of five one-minute bouts interspersed with five one-minute passive rest periods . The gravitational force was ~2.5 g for WBV and ~0.0 g for SWBV . Reliability of baseline dyspnoea , heart rate , and oxygen saturation was first established and then profiled for both sessions . Acute responses to both WBV and SWBV were compared with repeated measures analysis of variance and repeated contrasts . Small changes in dyspnoea and oxygen saturation lacked subjective and clinical meaningfulness . One session of WBV and SWBV significantly increased heart rate ( p ≤ 0.02 ) , although there was no difference among WBV and SWBV ( p = 0.67 ) . Conclusions This community-based proof-of-concept trial showed that a session of WBV can be completed with the absence of dyspnoea for people with COPD . Furthermore , there were no meaningful differences among WBV and SWBV for heart rate and oxygen saturation . There is scope for long-term community-based intervention research using WBV given the known effects of WBV on peripheral muscle function and functional independence BACKGROUND Patients with chronic obstructive pulmonary disease ( COPD ) often present with severe acute exacerbations requiring hospital treatment . However , little is known about the prognostic consequences of these exacerbations . A study was undertaken to investigate whether severe acute exacerbations of COPD exert a direct effect on mortality . METHODS Multivariate techniques were used to analyse the prognostic influence of acute exacerbations of COPD treated in hospital ( visits to the emergency service and admissions ) , patient age , smoking , body mass index , co-morbidity , long term oxygen therapy , forced spirometric parameters , and arterial blood gas tensions in a prospect i ve cohort of 304 men with COPD followed up for 5 years . The mean ( SD ) age of the patients was 71 ( 9 ) years and forced expiratory volume in 1 second was 46 (17)% . RESULTS Only older age ( hazard ratio ( HR ) 5.28 , 95 % CI 1.75 to 15.93 ) , arterial carbon dioxide tension ( HR 1.07 , 95 % CI 1.02 to 1.12 ) , and acute exacerbations of COPD were found to be independent indicators of a poor prognosis . The patients with the greatest mortality risk were those with three or more acute COPD exacerbations ( HR 4.13 , 95 % CI 1.80 to 9.41 ) . CONCLUSIONS This study shows for the first time that severe acute exacerbations of COPD have an independent negative impact on patient prognosis . Mortality increases with the frequency of severe exacerbations , particularly if these require admission to hospital Disease progression in cystic fibrosis ( CF ) leads to muscle wasting and loss of muscle function . The aim of this prospect i ve pilot study was to evaluate the effects of whole body vibration ( WBV ) on muscle function in adult patients with CF . Ten patients ( three males ; seven females ) of the CF Center Cologne , Germany , have completed the 3-month study ( age : 24–47 years ; forced expiratory volume in 1 s ( FEV1 ) 17–109 % predicted ( 49±29 ) and body mass index ( BMI ) 16.6–24.4 kg/m2 ( 19.3±2.5 ) . WBV was provided by a vibration platform ( Galileo 2000 ) . The patients were st and ing in an upright position receiving vertical vibration of frequencies between 20 and 25 Hz . The vibration exercise evokes muscle contractions via stretch reflexes improving muscular activity . The training schedule consisted of three 3-min sessions twice a day , 5 days per week for 3 months . Every 4 weeks the following tests were carried out : FEV1 , forced vital capacity ( FVC ) , BMI , chair-rising test ( CRT ) , one-leg and two-leg jump test as well as maximal isometric grip force . The study has been approved by the local ethics committee . After 3 months of WBV all parameters in the CRT significantly improved : chair-rising time ( P=0.03 ) , maximal force ( P=0.02 ) , maximal power ( P=0.01 ) as well as velocity ( P=0.02 ) . The peak jump force ( P=0.02 ) and velocity ( P=0.01 ) of the two-leg jump significantly improved . Parameters in the one-leg jump as well as maximal isometric grip force showed no significant improvement . Weight and BMI showed a slightly positive trend whereas FEV1 and FVC did not significantly change . Any change in mechanographic parameters did not correlate with FEV1 or FVC in this study . These results demonstrate that WBV can improve muscle function in CF patients Background Patients with stable COPD show improvements in exercise capacity and muscular function after the application of whole body vibration . We aim ed to evaluate whether this modality added to conventional physiotherapy in exacerbated hospitalised COPD patients would be safe and would improve exercise capacity and quality of life . Methods 49 hospitalised exacerbated COPD patients were r and omized ( 1:1 ) to undergo physiotherapy alone or physiotherapy with the addition of whole body vibration . The primary endpoint was the between-group difference of the 6-minute walking test ( day of discharge – day of admission ) . Secondary assessment s included chair rising test , quality of life , and serum marker analysis . Results Whole body vibration did not cause procedure-related adverse events . Compared to physiotherapy alone , it led to significantly stronger improvements in 6-minute walking test ( 95.55 ± 76.29 m vs. 6.13 ± 81.65 m ; p = 0.007 ) and St. Georges Respiratory Question naire ( -6.43 ± 14.25 vs. 5.59 ± 19.15 , p = 0.049 ) . Whole body vibration increased the expression of the transcription factor peroxisome proliferator receptor gamma coactivator-1-α and serum levels of irisin , while it decreased serum interleukin-8 . Conclusion Whole body vibration during hospitalised exacerbations did not cause procedure-related adverse events and induced clinical ly significant benefits regarding exercise capacity and health-related quality of life that were associated with increased serum levels of irisin , a marker of muscle activity . Trial registration German Clinical Trials Register DRKS00005979 . Registered 17 March 2014 Background Chronic obstructive pulmonary disease ( COPD ) is a respiratory condition characterised by dyspnoea , excessive sputum production , chronic cough , bronchitis and emphysema . Functionally , exercise tolerance is poor for people with COPD and is linked to difficulty in performing daily tasks . More specifically , exercise difficulties are due partly to dyspnoea and lower limb skeletal muscle dysfunction . The benefit of exercise that does not exacerbate the disease while improving exercise tolerance is salient . Whole-body vibration ( WBV ) is a mode of physical activity known to improve muscular function of the lower limbs , yet efficacy has not been investigated for a WBV intervention conducted in a home-based setting for people with COPD . Methods / design This clinical ly registered trial is a non-r and omised placebo cross-over intervention based in the home of each participant ( ACTRN12612000508875 ) . Participants diagnosed with COPD will complete a six-week WBV intervention and then after a two-week washout period , will complete a six-week placebo training intervention . Participants will complete sessions twice a week . The duration of the trial is 14 weeks . Community-dwelling older adults with COPD will provide informed voluntary consent to participate . Outcome measures will include immediate , acute , and long-term responses to exercise . Discussion Quantifying responses to WBV among people with COPD will allow discussion of efficacy of WBV as a mode of physical activity . The skill required by the participant to perform physical activity with WBV is not dem and ing and may enhance habitual sustainability . The results of this trial could be used to support further research in both clinical and community setting s . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR12612000508875 Background To examine the effects of whole body vibration ( WBV ) exposure on muscle function in children with Cystic Fibrosis ( CF ) . Non-r and omised controlled cross-over trial . Methods The setting was home-based WBV exposure . The participants were children ( 8 - 15 years ) with CF ( n = 7 ) . Intervention : participants served as their own controls for the first four weeks ( usual care ) , then underwent four weeks of parentally-supervised home-based WBV exposure followed by four weeks washout ( usual care ) . The WBV exposure consisted of 20 - 30 minutes of intermittent ( 1 min vibration:1 min rest ) exposure on a Galileo platform ( 20 - 22Hz , 1 mm amplitude ) 3 days/week . The primary outcome measures of absolute and relative lower body ( leg extension ( LE ) , leg press ( LP ) ) , upper body ( chess press ( CP ) ) strength and power , and power were measured at baseline , and weeks 4 , 8 and 12 . Secondary exploratory outcomes were cardiorespiratory fitness , pulmonary function and health-related quality of life . Results Six participants completed the training without adverse events . Muscle function changes following WBV exposure were not statistically significant . However , moderate-to-large relative effect sizes ( ES ) favouring WBV were evident for leg extension strength ( ES = 0.66 ( -0.50 , 1.82 ) ) , LP relative strength ( ES = 0.92 ( -0.27 , 2.11 ) ) , leg press peak power ( ES = 0.78 ( -0.50 , 2.07 ) ) and CMJ height ( ES = 0.60 ( -0.56 to 1.76 ) ) . Conclusions The results from this first controlled trial indicate that WBV may be a potentially effective exercise modality to safely increase leg strength and explosive power in children with CF . Potentially clinical ly relevant changes support continued investigation of the efficacy , mechanism and feasibility of this intervention in future large-scale studies INTRODUCTION To date endurance and strength training are established and evidence -based exercise methods in patients with chronic obstructive pulmonary disease ( COPD ) . There is an unmet need for further research in new and complementary exercise modalities . Additional whole body vibration training during pulmonary rehabilitation may be such a new approach that has not yet been investigated in patients with COPD . METHODS Eighty-two patients ( 65 ± 9 yrs , FEV(1 ) pred . 38 ± 11 % , female 51 % ) with COPD in GOLD stage III to IV assessed for a 3-week inpatient multidisciplinary rehabilitation program were on top r and omly assigned to one of two intervention groups : ( 1 ) 3 × 3 min of bilateral dynamic squat exercises on a side-alternating vibration platform at 24 - 26 Hz three times per week ( WBV ) and ( 2 ) a control group ( CON ) with the same amount of exercise time without WBV . RESULTS Thirty-six patients completed the study in each group . The improvement in 6-min walking distance was significantly higher in the WBV-group when compared to the CON-group ( WBV : 64 ± 59 m , CON : 37 ± 52 m with a between-group difference of 27 m [ 95 % CI , 1 - 53 ] , p = 0.046 ) . The time required for a sit-to-st and test also decreased more markedly in the WBV-group than in the CON-group ( WBV : -4.0 ± 4.8 s , CON : -2.0 ± 3.1 s with a between-group difference of -1.9 s [ 95 % CI , -4.0 to 0.1 ] , p = 0.067 ) . Improvements in health-related quality of life were similar in both groups . CONCLUSIONS WBV training seems to be a promising new exercise modality for patients with COPD and may enhance the effects of a multidisciplinary rehabilitation program OBJECTIVES The aim of this study was to investigate the effectiveness of a 6-week traditional exercise programme with supplementary whole-body vibration ( WBV ) in improving strength and health status in women with fibromyalgia ( FM ) . METHODS Thirty postmenopausal women with FM ( mean ( SD ) age : 59 ( 7.90 ) years ) were r and omised into one of two groups , one intervention group ( GEV n=15 ) , which combined exercise training ( two days a week ) with three days of WBV ( 3 sets of 45 s at 20 Hz-3 mm and four sets of unilateral static squats at 20 Hz-2 mm ) and another control group ( n=15 ) , that performed the same physical activity programme but without vibration training ( GEnV ) . The Fibromyalgia Impact Question naire ( FIQ ) and the global score of the SF-36 were used to assess functional capacity and quality of life . Two additional tests were employed to assess muscle strength . Baseline data and pre-test and post-test data were collected before and after the six-week intervention period . RESULTS Significant improvements in all outcomes measured were found from baseline in both groups . A 5 % improvement from baseline in total FIQ score was observed in the exercise groups ( p≤0.05 ) , and was accompanied by reductions in SF36 scores of 9.8 % ( p<0.001 ) and 7.9 % ( p<0.001 ) in the GEV and GEnV group , respectively . Improvements were also observed in muscle strength in both groups but greater in the GEV group . CONCLUSIONS The results suggest that women with FMS can gain additional health benefits by engaging in a 6-week traditional exercise programme with supplementary WBV BACKGROUND AND OBJECTIVE To determine if whole body vibration training ( WBVT ) improves muscular force and modifies functional capacity parameters in patients with severe chronic obstructive pulmonary disease ( COPD ) . METHODS We performed a r and omized controlled trial in the outpatient Physical Medicine and Rehabilitation Department of a general hospital . Sixty stable male patients with COPD and mean forced expiratory volume in 1 s ( FEV1 ) 34.3 % ( predicted ) were enrolled with 51 patients completing the study . Participants were r and omized into two groups : Whole Body Vibration Training Group ( WBVTG ) , ( n = 26 ) undergoing three sessions per week for a total of 6 weeks and a Control Group ( CG ) ( n = 25 ) without intervention . The main outcome measures were isokinetic knee flexor and extensor testing in a concentric-concentric regime and exercise capacity measured by the 6-min walking test ( 6MWT ) . Secondary outcomes were pulmonary muscular assessment with maximum inspiratory pressure ( MIP ) and maximum expiratory pressure ( MEP ) . RESULTS No significant differences were observed between groups in maximum moment of isokinetic knee flexor/extensor testing force in a concentric-concentric regime . In contrast , WBVTG patients showed a significant increase in the 6MWT ( 81.2 ± 9.2 ) meters ; mean ± SD ; P < 0.001 ) . There was also a significant decrease in maximum oxygen desaturation in the 6MWT after 6 weeks of training ( 3.1 ± 1.1 ; P = 0.01 ) . There were significant differences between groups in MIP and MEP at the end of the study in favour of the WBVTG . CONCLUSIONS WBVT provided significant improvements in functional capacity in severe COPD patients without changes in muscular force BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from " fair " to " substantial , " and the reliability of the total PEDro score was " fair " to " good . This study sought to analyze the postural responses induced by separately or simultaneously vibrating with different frequencies the forefoot and rear foot zones of both soles in st and ing subjects . Stimulating each zone separately result ed in spatially oriented body tilts ; their amplitude and velocity varied linearly according to the frequency , and their direction was always opposite to the plantar site vibrated . When the two zones were each co-stimulated at different frequencies , the parameters of the postural responses depended on the frequency difference . When this frequency difference was zero , no clearly oriented body tilts occurred . We concluded that the change in the relative pressures evoked by differently co-vibrating these zones gave rise to regulative postural adjustments able to cancel the simulated body deviation RATIONALE We have previously reported that regular physical activity reduces risk of chronic obstructive pulmonary disease ( COPD ) exacerbation . We hypothesized that higher levels of regular physical activity could reduce the risk of COPD by modifying smoking-related lung function decline . OBJECTIVE To estimate the longitudinal association between regular physical activity and FEV(1 ) and FVC decline and COPD risk . METHODS A population -based sample ( n = 6,790 ) was recruited and assessed with respect to physical activity , smoking , lung function , and other covariates , in Copenhagen in 1981 - 1983 , and followed until 1991 - 1994 . Mean level of physical activity between baseline and follow-up was classified into " low , " " moderate , " and " high . " FEV(1 ) and FVC decline rates were expressed as milliliters per year . COPD was defined as FEV(1)/FVC < or = 70 % . Adjusted associations between physical activity and FEV(1 ) and FVC decline , and COPD incidence , were obtained using linear and logistic regression , respectively . RESULTS Active smokers with moderate and high physical activity had a reduced FEV(1 ) and FVC decline compared with those with low physical activity ( relative change of + 2.6 and + 4.8 ml/yr of FEV(1 ) , P-for-trend = 0.006 , and + 2.6 and + 7.7 ml/yr of FVC , P-for-trend < 0.0001 , for the moderate and high physical activity group , respectively ) , after adjusting for all potential confounders and risk factors of lung function decline . Active smokers with moderate to high physical activity had a reduced risk of developing COPD as compared with the low physical activity group ( odds ratio , 0.77 ; p = 0.027 ) . CONCLUSIONS This prospect i ve study shows that moderate to high levels of regular physical activity are associated with reduced lung function decline and COPD risk among smokers Aim of the study was to evaluate mortality and functional , cognitive , affective status in elderly patients ( > or=75 years ) with exacerbation of chronic obstructive pulmonary disease ( COPD ) or acute congestive heart failure ( CHF ) admitted to the emergency department ( ED ) of S. Giovanni Battista Hospital of Torino and r and omly assigned to the geriatric home hospitalization service ( GHHS ) or to a general medical ward ( GMW ) . All patients were evaluated on admission , on discharge and at 6 months , using a st and ardized study protocol . We excluded patients with unstable medical conditions . The total sample included 73 patients : 35 with COPD exacerbation ( 19 GHHS , 16 GMW ) and 38 with CHF ( 19 GHHS , 19 GMW ) . Mean age was 81.7+/-8.0 years . At baseline , no significant differences in demographic , social and clinical conditions were found between the two groups of patients . 56.7 % of COPD patients had a severe exacerbation , according to Anthonisen criteria ; 65 % of CHF patients were NYHA-III and 35 % NYHA-IV ( according to the criteria of the New York Heart Association ) ( FE<35 % in 40 % of patients ) . On admission all patients were partially dependent in ADLs and IADLs , with a moderate impairment of depression score and a fairly good quality of life . On discharge depression score and quality of life were significantly better only in GHHS patients . Mortality was similar in the two setting of care . Patients managed at home had a significantly longer length of treatment . At 6-month follow-up we did not observe a difference in mortality , but we observed a higher readmission rate in patients previously treated in hospital . In conclusion , our study indicates that home-treated patients with COPD or CHF have better depressive scores and quality of life and a lower rate of hospital readmission after six months OBJECTIVE To test the feasibility and effectiveness of whole-body vibration ( WBV ) therapy on fall risk , functional dependence and health-related quality of life in nursing home residents aged 80 + years . DESIGN Twenty-nine 80 - 95 years old volunteers , nursing home residents were r and omized to an eight-week WBV intervention group ) ( n=15 ) or control group ( n=14 ) . Functional mobility was assessed using the timed up and go ( TUG ) test . Lower limb performance was evaluated using the 30-s Chair Sit to St and ( 30-s CSTS ) test . Postural stability was measured using a force platform . The Barthel Index was used to assess functional dependence and the EuroQol ( EQ-5D ) was used to evaluate Health-Related Quality of Life . All outcome measures were assessed at baseline and at a follow-up after 8 weeks . RESULTS At the 8-week follow up , TUG test ( p<0.001 ) , 30-s CSTS number of times ( p=0.006 ) , EQ-5Dmobility ( p<0.001 ) , EQ-5DVAS ( p<0.014 ) , EQ-5Dutility ( p<0.001 ) and Barthel index ( p=0.003 ) improved in the WBV intervention group when compared to the control group . CONCLUSIONS An 8-week WBV-based intervention in a nursing home setting is effective in reducing fall risk factors and quality of life in nursing home residents aged 80 + OBJECTIVES The aim of this study was to analyze the effect of 12-week tilting Whole Body Vibration therapy ( WBV ) on Health Related Quality of Life ( HRQoL ) in fibromylagia ( FM ) within the context of a r and omized control trial ( IS RCT N16950947 ) . SUBJECTS AND METHODS Thirty-six ( 36 ) women with FM were r and omly allocated to either an exercise or a control group . The women in the exercise group were assigned to a 12-week course of tilting WBV ( 12.5-Hz frequency ; 3-mm amplitude ) . HRQoL was assessed using the Fibromyalgia Impact Question naire ( FIQ ) and a 15D question naire . RESULTS A 12-week course of tilting WBV therapy was associated with improvements in FIQ scores ( 12 % ) but not in the 15D question naire . CONCLUSIONS Tilting WBV was a feasible intervention that prevented the loss of HRQoL in previously physically untrained women with FM Rhea , MR , Bunker , D , Marín , PJ , and Lunt , K. Effect of iTonic whole-body vibration on delayed-onset muscle soreness among untrained individuals . J Strength Cond Res 23(6 ) : 1677 - 1682 , 2009-Attempts to reduce or eliminate delayed-onset of muscle soreness are important as this condition is painful and debilitating . The purpose of this study was to examine the effectiveness of whole-body vibration ( WBV ) massage and stretching exercises at reducing perceived pain among untrained men . Sixteen adult men ( age , 36.6 ± 2.1 yr ) volunteered to perform a strenuous exercise session consisting of resistance training and repeated sprints . Subjects were r and omly assigned to 1 of 2 recovery groups : a group performing WBV stretching sessions or a stretching group performing static stretching without vibration . Both groups performed similar stretches , twice per day for 3 days after the workout . The vibration group performed their stretches on the iTonic platform ( frequency , 35 Hz ; amplitude , 2 mm ) . Perceived pain was measured at 12 , 24 , 48 , and 72 hours postworkout . Statistical analyses identified a significantly lower level of reported perceived pain at all postworkout measurement times among the WBV group ( p < 0.05 ) . No difference existed at the preworkout measurement time . The degree of attenuation of pain ranged from 22 - 61 % . These data suggest that incorporating WBV as a recovery/regeneration tool may be effective for reducing the pain of muscle soreness and tightness after strenuous training |
1,307 | 30,219,036 | Some cognitive interventions improved non-cognitive symptoms such as anxiety , depression , and ADLs . | Background Individuals with mild cognitive impairment ( MCI ) are at heightened risk of developing dementia .
Rapid advances in computing technology have enabled research ers to conduct cognitive training and rehabilitation interventions with the assistance of technology .
This systematic review aims to evaluate the effects of technology-based cognitive training or rehabilitation interventions to improve cognitive function among individuals with MCI . | [ Purpose ] This study investigates whether cognition , balance and dual task performance in institutionalized older adults improves by a virtual reality dual task training . [ Subjects and Methods ] R and omized controlled trial ; Twenty institutionalized older adults with mild cognitive impairment ( 13 female , 7 male ; average age , 87.2 ± 5.96 years ) were r and omized to the intervention ( i.e. Virtual reality dual-task training using the BioRescue ) or control group ( no additional training ) . The intervention group took part in a 6-week training program while the elderly in the control group maintained their daily activities . Balance was measured with the Instrumented Timed Up- and -Go Test with and without a cognitive task . The Observed Emotion Rating Scale and Intrinsic Motivation Inventory were administered to evaluate the emotions and motivation regarding the exergaming program . [ Results ] The intervention group improved significantly on the total Timed Up- and -Go duration and the turn-to-sit duration during single-task walking in comparison to the control group who received no additional training . Participants found the virtual reality dual task training pleasant and useful for their concentration , memory and balance . Pleasure and alertness were the two emotions which were mostly seen during the intervention . [ Conclusion ] The BioRescue is a pleasant and interesting treatment method , well suited for institutionalized older adults in need of lifelong physical therapy The aim of the current study was to compare the effectiveness of two types of cognitive training in 60 older adults with mild cognitive impairment by assessing the impact on functional activities , quality of life ( QOL ) , and various cognitive functions . The primary outcomes were functional activity level and QOL . The secondary outcome was cognitive examination . Group assignment was r and om . Group A ( n = 30 ) underwent CogniPlus , a computer-based , cognitive training . Group B ( n = 30 ) underwent classical group-based cognitive training . Both programs comprised two 30-minute sessions per week for 10 weeks . After training , group A had better QOL ( p < 0.001 , effect size [ ES ] = 0.69 ) and better attention ( increased load score , p < 0.05 , ES = -0.23 ; errors , p < 0.001 , ES = -0.47 ) ; however , there were no group differences in functional activity level . Group A demonstrated larger improvements in QOL and attention than group B ( i.e. , classical cognitive training ) , but the transfer to functional activities was the same between groups . [ Res Gerontol Nurs . 2017 ; 10(4):172 - 180 . ] Abstract Background Cognitive training is effective in patients with mild cognitive impairment but does not typically address the motivational deficits associated with older population s with memory difficulties . Methods We conducted a r and omized controlled trial of cognitive training using a novel memory game on an iPad in 42 patients with a diagnosis of amnestic mild cognitive impairment assigned to either the cognitive training ( n=21 ; 8 hours of gameplay over 4 weeks ) or control ( n=21 ; clinic visits as usual ) groups . Results Significant time-by-pattern-by-group interactions were found for cognitive performance in terms of the number of errors made and trials needed on the Cambridge Neuropsychological Test Automated Battery Paired Associates Learning task ( P=.044 ; P=.027 ) . Significant time-by-group interactions were also found for the Cambridge Neuropsychological Test Automated Battery Paired Associates Learning first trial memory score ( P=.002 ) , Mini-Mental State Examination ( P=.036 ) , the Brief Visuospatial Memory Test ( P=.032 ) , and the Apathy Evaluation Scale ( P=.026 ) . Within-group comparisons revealed highly specific effects of cognitive training on episodic memory . The cognitive training group maintained high levels of enjoyment and motivation to continue after each hour of gameplay , with self-confidence and self-rated memory ability improving over time . Conclusions Episodic memory robustly improved in the cognitive training group . “ Gamified ” cognitive training may also enhance visuospatial abilities in patients with amnestic mild cognitive impairment . Gamification maximizes engagement with cognitive training by increasing motivation and could complement pharmacological treatments for amnestic mild cognitive impairment and mild Alzheimer ’s disease . Larger , more controlled trials are needed to replicate and extend these findings ABSTRACT Objectives : Deficits in working memory ( WM ) are associated with age-related decline . We report findings from a clinical trial that examined the effectiveness of Cogmed , a computerized program that trains WM . We compare this program to a Sham condition in older adults with Mild Cognitive Impairment ( MCI ) . Methods : Older adults ( N = 68 ) living in the community were assessed . Participants reported memory impairment and met criteria for MCI , either by poor delayed memory or poor performance in other cognitive areas . The Repeatable Battery for the Assessment of Neuropsychological Status ( RBANS , Delayed Memory Index ) and the Clinical Dementia Rating scale ( CDR ) were utilized . All presented with normal Mini Mental State Exams ( MMSE ) and activities of daily living ( ADLs ) . Participants were r and omized to Cogmed or a Sham computer program . Twenty-five sessions were completed over five to seven weeks . Pre , post , and follow-up measures included a battery of cognitive measures ( three WM tests ) , a subjective memory scale , and a functional measure . Results : Both intervention groups improved over time . Cogmed significantly outperformed Sham on Span Board and exceeded in subjective memory reports at follow-up as assessed by the Cognitive Failures Question naire ( CFQ ) . The Cogmed group demonstrated better performance on the Functional Activities Question naire ( FAQ ) , a measure of adjustment and far transfer , at follow-up . Both groups , especially Cogmed , enjoyed the intervention . Conclusions : Results suggest that WM was enhanced in both groups of older adults with MCI . Cogmed was better on one core WM measure and had higher ratings of satisfaction . The Sham condition declined on adjustment ABSTRACT Cognitive rehabilitation for mild cognitive impairment ( MCI ) and early Alzheimer 's disease is readily available to the geriatric population . Initial evidence suggests that techniques incorporating motivational strategies to enhance treatment engagement may provide more benefit than computerised training alone . Seventy four adults with sub clinical cognitive decline were r and omly assigned to computerised cognitive training ( CCT ) , Cognitive Vitality Training ( CVT ) , or an Active Control Group ( ACG ) , and underwent neuropsychological evaluations at baseline and four-month follow-up . Significant differences were found in changes in performance on the Modified Mini Mental State Examination ( mMMSE ) and measures of verbal learning and memory across treatment groups . Experimental groups showed greater preservation of functioning on the mMMSE than the ACG group , the CVT group performed better than the ACG group on one measure of verbal learning and both measures of verbal memory , and the CCT group performed better than the ACG group on one measure of verbal learning and one measure of verbal memory . There were no significant group differences between the CVT and CCT groups on measures of verbal learning or memory . It was concluded that computerised cognitive training may offer the most benefit when incorporated into a therapeutic milieu rather than administered alone , although both appear superior to more generic forms of cognitive stimulation We performed a pilot r and omized , controlled trial of intensive , computer-based cognitive training in 47 subjects with mild cognitive impairment . The intervention group performed exercises specifically design ed to improve auditory processing speed and accuracy for 100 min/d , 5 d/wk for 6 weeks ; the control group performed more passive computer activities ( reading , listening , visuospatial game ) for similar amounts of time . Subjects had a mean age of 74 years and 60 % were men ; 77 % successfully completed training . On our primary outcome , Repeatable Battery for Assessment of Neuropsychological Status total scores improved 0.36 st and ard deviations ( SD ) in the intervention group ( P=0.097 ) compared with 0.03 SD in the control group ( P=0.88 ) for a nonsignificant difference between the groups of 0.33 SD ( P=0.26 ) . On 12 secondary outcome measures , most differences between the groups were not statistically significant . However , we observed a pattern in which effect sizes for verbal learning and memory measures tended to favor the intervention group whereas effect sizes for language and visuospatial function measures tended to favor the control group , which raises the possibility that these training programs may have domain-specific effects . We conclude that intensive , computer-based mental activity is feasible in subjects with mild cognitive impairment and that larger trials are warranted A r and omized pilot experiment examined the neural substrates of response to cognitive training in participants with mild cognitive impairment ( MCI ) . Participants performed exercises previously demonstrated to improve verbal memory and an active control group performed other computer activities . An auditory-verbal fMRI task was conducted before and after the two-month training program . Verbal memory scores improved significantly and left hippocampal activation increased significantly in the experimental group ( gains in 5 of 6 participants ) relative to the control group ( reductions in all 6 participants ) . Results suggest that the hippocampus in MCI may retain sufficient neuroplasticity to benefit from cognitive training Objective : To investigate the 10-year risk of dementia in subjects with mild cognitive impairment ( MCI ) ages 40 to 85 years . Methods : We selected subjects from a memory clinic if they met one of the following definitions of MCI : cognitive complaints ( n = 181 ) , aging-associated cognitive decline ( AACD ) ( n = 163 ) , mild functional impairment ( n = 86 ) , or amnestic MCI ( n = 64 ) . Subjects were reassessed after 2 , 5 , and 10 years . The risk of dementia was calculated with Kaplan-Meier statistics . Analyses were conducted in the entire sample and in subgroups of subjects aged 40 to 54 years , 55 to 69 years , and 70 to 85 years . Results : The 10-year risk of dementia was 0.27 ( 95 % CI 0.20 to 0.34 ) in subjects with cognitive complaints , 0.28 ( 95 % CI 0.21 to 0.35 ) in subjects with AACD , 0.44 ( 95 % CI 0.32 to 0.56 ) in subjects with mild functional impairment , and 0.48 ( 95 % CI 0.35 to 0.61 ) in subjects with amnestic MCI . Ninety-one percent of the demented subjects had probable AD . The risk of dementia increased with increasing age for all MCI definitions ( p < 0.001 ) . Depending on the MCI definition used , the risk for dementia ranged from 0 to 0.06 in subjects aged 40 to 54 years , from 0.37 to 0.52 in subjects aged 55 to 69 years , and from 0.77 to 1.0 in subjects aged 70 to 85 years . Conclusions : The majority of subjects with MCI do not progress to dementia at the long term . Age strongly influences the dementia risk . MCI often represents the predementia stage of a neurodegenerative disorder in elderly subjects but rarely in younger subjects This study evaluated the efficacy of a cognitive intervention for attentional control in older adults with mild cognitive impairment ( MCI ) with an executive deficit . It also sought to verify if the benefits of training generalised to primary and secondary outcome measures . Participants ( n = 24 ) were r and omly assigned to a training programme or active control condition . The experimental group completed a computer-based training programme involving Variable Priority ( VP ) coordination of both components of a dual task , to which was added a self-regulatory strategy design ed to augment meta-cognition . The active control group performed Fixed Priority ( FP ) training : rote practice of the same dual task involving a visual detection task combined with an alpha-arithmetic task . Six one-hour training sessions were held three times a week for two weeks . Participants were tested pre- and post-training to detect improvement and transfer effects . Both groups improved on the visual detection and alpha-arithmetic tasks completed in focused attention , but only participants receiving VP training significantly improved their dual-task cost in accuracy for the visual detection task . As for transfer effects , both FP and VP training produced improvements on select outcome measures : focused attention , speed of processing , and switching abilities . No reliable advantage for generalisability of VP over FP training was found . Overall , these findings indicate that cognitive intervention may improve attentional control in persons with MCI and an executive deficit BACKGROUND Mild cognitive impairment ( MCI ) increases dementia risk with no pharmacologic treatment available . METHODS The Study of Mental and Resistance Training was a r and omized , double-blind , double-sham controlled trial of adults with MCI . Participants were r and omized to 2 supervised interventions : active or sham physical training ( high intensity progressive resistance training vs seated calisthenics ) plus active or sham cognitive training ( computerized , multidomain cognitive training vs watching videos/quizzes ) , 2 - 3 days/week for 6 months with 18-month follow-up . Primary outcomes were global cognitive function ( Alzheimer 's Disease Assessment Scale-cognitive subscale ; ADAS-Cog ) and functional independence ( Bayer Activities of Daily Living ) . Secondary outcomes included executive function , memory , and speed/attention tests , and cognitive domain scores . RESULTS One hundred adults with MCI [ 70.1 ( 6.7 ) years ; 68 % women ] were enrolled and analyzed . Resistance training significantly improved the primary outcome ADAS-Cog ; [ relative effect size ( 95 % confidence interval ) -0.33 ( -0.73 , 0.06 ) ; P < .05 ] at 6 months and executive function ( Wechsler Adult Intelligence Scale Matrices ; P = .016 ) across 18 months . Normal ADAS-Cog scores occurred in 48 % ( 24/49 ) after resistance training vs 27 % ( 14/51 ) without resistance training [ P < .03 ; odds ratio ( 95 % confidence interval ) 3.50 ( 1.18 , 10.48 ) ] . Cognitive training only attenuated decline in Memory Domain at 6 months ( P < .02 ) . Resistance training 18-month benefit was 74 % higher ( P = .02 ) for Executive Domain compared with combined training [ z-score change = 0.42 ( 0.22 , 0.63 ) resistance training vs 0.11 ( -0.60 , 0.28 ) combined ] and 48 % higher ( P < .04 ) for Global Domain [ z-score change = .0.45 ( 0.29 , 0.61 ) resistance training vs 0.23 ( 0.10 , 0.36 ) combined ] . CONCLUSIONS Resistance training significantly improved global cognitive function , with maintenance of executive and global benefits over 18 months OBJECTIVES To examine the cognitive and neural effects of vision-based speed-of-processing ( VSOP ) training in older adults with amnestic mild cognitive impairment ( aMCI ) and contrast those effects with an active control ( mental leisure activities ( MLA ) ) . DESIGN R and omized single-blind controlled pilot trial . SETTING Academic medical center . PARTICIPANTS Individuals with aMCI ( N = 21 ) . INTERVENTION Six-week computerized VSOP training . MEASUREMENTS Multiple cognitive processing measures , instrumental activities of daily living ( IADLs ) , and two resting state neural networks regulating cognitive processing : central executive network ( CEN ) and default mode network ( DMN ) . RESULTS VSOP training led to significantly greater improvements in trained ( processing speed and attention : F1,19 = 6.61 , partial η(2 ) = 0.26 , P = .02 ) and untrained ( working memory : F1,19 = 7.33 , partial η(2 ) = 0.28 , P = .01 ; IADLs : F1,19 = 5.16 , partial η(2 ) = 0.21 , P = .03 ) cognitive domains than MLA and protective maintenance in DMN ( F1 , 9 = 14.63 , partial η(2 ) = 0.62 , P = .004 ) . VSOP training , but not MLA , result ed in a significant improvement in CEN connectivity ( Z = -2.37 , P = .02 ) . CONCLUSION Target and transfer effects of VSOP training were identified , and links between VSOP training and two neural networks associated with aMCI were found . These findings highlight the potential of VSOP training to slow cognitive decline in individuals with aMCI . Further delineation of mechanisms underlying VSOP-induced plasticity is necessary to underst and in which population s and under what conditions such training may be most effective OBJECTIVE We evaluated the feasibility of a trial of Wii interactive video gaming , and its potential efficacy at improving cognitive functioning compared with health education , in a community sample of older adults with neuropsychologically defined mild cognitive impairment . METHODS Twenty older adults were equally r and omized to either group-based interactive video gaming or health education for 90 min each week for 24 weeks . Although the primary outcomes were related to study feasibility , we also explored the effect of the intervention on neuropsychological performance and other secondary outcomes . RESULTS All 20 participants completed the intervention , and 18 attended at least 80 % of the sessions . The majority ( 80 % ) of participants were " very much " satisfied with the intervention . Bowling was enjoyed by the most participants and was also rated the highest among the games for mental , social , and physical stimulation . We observed medium effect sizes for cognitive and physical functioning in favor of the interactive video gaming condition , but these effects were not statistically significant in this small sample . CONCLUSION Interactive video gaming is feasible for older adults with mild cognitive impairment , and medium effect sizes in favor of the Wii group warrant a larger efficacy trial BACKGROUND Computerized Cognitive Training ( CCT ) has been shown to improve cognitive function in older adults with mild cognitive impairment ( MCI ) or mood-related neuropsychiatric symptoms ( MrNPS ) , but many questions remain unresolved . OBJECTIVE To evaluate the extent to which CCT benefits older adults with both MCI and MrNPS , and its effects on meta-cognitive and non-cognitive outcomes , as well as establish whether adapting difficulty levels and tailoring to individuals ' profile is superior to generic training . METHODS Older adults with MCI ( n = 9 ) , MrNPS ( n = 11 ) , or both ( MCI+ , n = 25 ) were r and omized into a home-based individually-tailored and adaptive CCT ( n = 21 ) or an active control condition ( AC ; n = 23 ) in a double-blind design . Interventions lasted 8 - 12 weeks and outcomes were assessed after the intervention , and at a 3-month follow-up . RESULTS Participants in both conditions reported greater satisfaction with their everyday memory following intervention and at follow-up . However , participants in the CCT condition showed greater improvement on composite measures of memory , learning , and global cognition at follow-up . Participants with MrNPS in the CCT condition were also found to have improved mood at 3-month follow-up and reported using fewer memory strategies at the post-intervention and follow-up assessment s. There was no evidence that participants with MCI+ were disadvantaged relative to the other diagnostic conditions . Finally , informant-rated caregiver burden declined at follow-up assessment in the CCT condition relative to the AC condition . CONCLUSIONS Home-based CCT with adaptive difficulty and personal tailoring appears superior to more generic CCT in relation to both cognitive and non-cognitive outcomes . Mechanisms of treatment effect and future directions are discussed |
1,308 | 19,370,559 | Osteotomy was associated with an increased operative blood loss and length of surgery .
There were no statistically significant differences for mortality , morbidity or measures of anatomical deformity .
The cement group had significantly better quality of life scores at six months .
There is inadequate evidence to support the use of osteotomy for internal fixation of a trochanteric hip fracture .
Similarly , there is insufficient evidence to support the use of the other techniques examined in the trials included in this review | BACKGROUND Many different surgical techniques have been described for the internal fixation of extracapsular hip fractures .
OBJECTIVES To compare different aspects of surgical technique used in operations for internal fixation of extracapsular hip fractures in adults . | A series of 100 consecutive patients with unstable intertrochanteric fractures were treated by compression hip screw fixation ; 55 patients had an anatomical reduction ( Group 1 ) and 45 patients a Sarmiento osteotomy and valgus reduction ( Group 2 ) . Group 1 spent an average of 10 days less in hospital than Group 2 ( 21 days compared with 31 days ) ( P less than 0.02 ) . They also had a greater chance of returning to their pre-injury accommodation and of achieving their pre-injury walking capability . Radiological failure of fracture fixation , with varus angulation of the femoral head by cutting out of the screw , was seen seven times in Group 1 but only once in Group 2 . Anatomical reduction provides better clinical results than valgus osteotomy in the patient with an unstable intertrochanteric fracture stabilized by a compression hip screw . The capacity for failure of fracture fixation is greater , however , in the former . Valgus osteotomy provides a simple means of securing a stable reduction of the fracture which can not be satisfactorily reduced by closed means Osteotomy has been used in the treatment of unstable intertrochanteric hip fractures in an attempt to increase the stability of the fracture fragments . We have assessed this stability in a r and omised prospect i ve trial on 100 consecutive patients , all having fixation by an AO dynamic hip screw , comparing anatomical reduction with two types of osteotomy . The groups were similar in terms of age , gender , mental test score , and fracture configuration . There were more failures of fixation in the osteotomy groups , and the operations took longer . We found no clear benefit from osteotomy and therefore recommend anatomical reduction and fixation by a sliding hip screw in most cases . Rarely , a fracture configuration which does not allow load-sharing between the fracture fragments and the device may benefit from an osteotomy or the use of an alternative implant Objective This study evaluates the safety and outcome of a minimally invasive technique for inserting a st and ard dynamic hip screw for intertrochanteric fractures . Hypothesis The use of st and ard plate in a minimally invasive technique is both possible and advantageous to patient outcome . Design and Methods Prospect i ve surgeon-r and omized blinded outcome clinical study comparing new technique to conventional technique . Main Outcome Measure Pain , operative time and mean hemoglobin drop in percutaneous hip fixation . Results The minimally invasive technique had significantly less blood loss ( P < 0.001 ) , operative time ( P < 0.001 ) and a trend to less morphine use . Conclusions Minimal invasive technique significantly reduces blood loss and operative time for fixation of intertrochanteric hip fractures without sacrifice of fixation stability or bone healing The triple reamer is a convenient tool for reaming the proximal femur when using a sliding screw and plate device , but unnecessarily high temperatures may be generated within the femoral head while the lateral cortex is being reamed . Nineteen female patients over 60 years old were r and omized to either the st and ard or a modified reaming technique with the triple reamer during internal fixation of proximal femoral fractures . Temperatures generated within the femoral head were measured . Results showed a mean peak temperature of 51.9 degrees C ( range 42 - 66 ) using the st and ard method and 46.3 degrees C ( range 40 - 52 ) using the modified method ( P = 0.07 ) . A significant difference ( P < 0.05 ) was found in the duration of temperature elevation above the critical 44 degrees C ( 17.4s vs 5.7s ) , it being prolonged in the st and ard group . Even in this osteoporotic patient group , damaging temperatures which may contribute to the mechanical failure of fixation , are generated within the femoral head . A simple method to avoid this problem is described We undertook a multicentre , prospect i ve study of a series of 112 unstable trochanteric fractures in order to evaluate if internal fixation with a sliding screw device combined with augmentation using a calcium phosphate degradable cement ( Norian SRS ) could improve the clinical , functional and radiological outcome when compared with fractures treated with a sliding screw device alone . Pain , activities of daily living , health status ( SF-36 ) , the strength of the hip abductor muscles and radiological outcome were analysed . Six weeks after surgery , the patients in the augmented group had significantly lower global and functional pain scores ( p < 0.003 ) , less pain after walking 50 feet ( p < 0.01 ) , and a better return to the activities of daily living ( p < 0.05 ) . At follow-up at six weeks and six months , those in the augmented group showed a significant improvement compared with the control group in the SF-36 score . No other significant differences were found between the groups . We conclude that augmentation with calcium phosphate cement in unstable trochanteric fractures provides a modest reduction in pain and a slight improvement in the quality of life during the course of healing when compared with conventional fixation with a sliding screw device alone We report a prospect i ve clinical trial of 150 cases for the treatment of unstable intertrochanteric fracture of the neck of the femur . Three methods were tested in our series -- skeletal traction with a tibial pin , medial displacement osteotomy and valgus osteotomy -- with 50 patients in each group . Our results showed no significant difference between those treated with the Dimon and Hughston osteotomy and those treated by the Sarmiento osteotomy . Conservative treatment of skeletal traction for unstable fracture was found to be well tolerated by the Chinese patient . A low mortality and morbidity rate was found in this series with an overall infection rate of 4 per cent 153 patients with a trochanteric hip fracture were operated on with a compression hip screw ( CHS ) and followed for 4 months . They were r and omized into 2 groups , with or without a key and compression of the lag screw . Greater sliding of the lag screw was noted in cases where the compression screw and the key were used , especially in women over 80 years of age and in patients with a previous fracture indicating osteoporotic bone . Use of a key and compression of the lag screw gave no advantage , and we do not recommend this for treatment of trochanteric hip fractures This study was done to determine if elderly patients with trochanteric fractures and with osteoporosis could benefit from treatment with a dynamic hip screw fixed with HA-coated AO/ASIF screws . One hundred twenty patients with AO , A1 , or A2 trochanteric fractures were selected . Patients were divided into two groups and r and omized to receive a 135 ° -four – hole dynamic hip screw fixed with either st and ard lag and cortical AO/ASIF screws ( Group A ) , or HA-coated lag and cortical AO/ASIF screws ( Group B ) . Lag screw cutout occurred in four patients in Group A , but not in any patients in Group B. In Group A , the femoral neck shaft angle was 134 ° ± 5 ° postoperatively and 127 ° ± 12 ° at 6 months . In Group B , the femoral neck shaft angle was 134 ° ± 7 ° postoperatively and 133 ° ± 7 ° at 6 months . The Harris hip score at 6 months was 60 ± 25 in Group A and 71 ± 18 in Group B. The superior results of Group B can be attributed to the increased screw fixation provided by the HA-coated screws . We recommend lag screws coated with HA for dynamic hip screw fixation , especially in osteoporotic bone Sliding hip screws have improved the treatment of unstable intertrochanteric hip fractures and their success , compared with fixed devices , is in large part due to the sharing of load between the implant and the fracture fragments . In a prospect i ve study of 100 patients with such fractures , five factors concerned with the fracture and its fixation were studied and odds ratios calculated of their relative importance in prediction of failure . The most important factor affecting the load borne by the fracture fragments was the amount of slide available within the device , and that affecting the load carried by the device was the position of the screw in the femoral head . For fractures fixed with a device allowing less than 10 mm of slide , and those with superior screw position , the risk of failure was increased by factors of 3.2 and 5.9 , respectively . Anatomical reduction alone , rather than osteotomy , together with sliding hip screw fixation , has been recommended for these fractures in three prospect i ve r and omized trials . It is calculated here that to allow sufficient slide when employing this technique , it is essential to use a short barrel device when using dynamic screws of 85 mm or less . This has not been demonstrated before We conducted a prospect i ve r and omised trial to compare the results of anatomical reduction and medial displacement osteotomy in 127 consecutive patients with unstable intertrochanteric fractures , of whom 109 completed the study . After an average follow-up of 11 months , we found no significant differences in walking ability , social status or failure of fixation in the two groups . Postoperative complication rates and the early mortality rate were not significantly different , but operating time and blood loss were significantly higher in the osteotomy group . With the use of modern sliding hip screws , medial displacement osteotomy is rarely indicated for unstable intertrochanteric fractures A total of 62 patients with unstable pertrochanteric fractures of the neck of the femur was subjected to either nail plating with 130 degrees neck-shaft angle or valgus osteotomy using a neck-shaft angle of at least 140 degrees . The patients were assessed in terms of ability to walk and stability of fracture fixation . A clear superiority of valgus osteotomy over the controls was demonstrated in terms of fracture fixation , but the difference in terms of ability to walk was less remarkable BACKGROUND Animal studies have demonstrated the efficacy of the use of bisphosphonates to enhance screw fixation in bone . In this prospect i ve , r and omized study of pertrochanteric fractures treated with external fixation , we tested whether systemic administration of bisphosphonates would improve the fixation of hydroxyapatite-coated screws implanted in osteoporotic bone . METHODS Sixteen consecutive patients with a pertrochanteric fracture were selected . Inclusion criteria were female gender , an age of at least sixty-five years , and a bone mineral density T-score of less than -2.5 st and ard deviations . Exclusion criteria included bisphosphonate treatment during the two-year period prior to the fracture . Fractures were fixed with a pertrochanteric fixator and four hydroxyapatite-coated pins . Two pins were implanted in the femoral head ( pin positions 1 and 2 ) , and two were placed in the femoral diaphysis ( pin positions 3 and 4 ) . The patients were r and omized either to therapy with alendronate for a three-month postoperative period ( Group A ) or to no therapy ( Group B ) . The Group-A patients received an oral dose of 70 mg of alendronate per week . The fixators were removed after three months . RESULTS All of the fractures healed , and no loss of reduction , nonunion , or delayed union was observed . The combined mean extraction torque ( and st and ard deviation ) of the pins implanted at positions 1 and 2 ( cancellous bone ) was 2558 + /- 1103 N/mm in Group A and 1171 + /- 480 N/mm in Group B ( p < 0.0005 ) . The combined mean extraction torque of the pins implanted at positions 3 and 4 ( cortical bone ) was 4327 + /- 1720 N/mm in Group A and 4075 + /- 1022 N/mm in Group B. CONCLUSIONS These data show that weekly systemic administration of alendronate improves pin fixation in cancellous bone in elderly female patients with osteoporosis . We observed a twofold increase in extraction torque with the pins implanted in cancellous bone . These results support the use of alendronate in the treatment of osteoporotic pertrochanteric fractures to improve screw fixation in the femoral head |
1,309 | 27,891,666 | Conclusion Outcome reporting from RCTs concerning medication review in older patients is heterogeneous . | Aim Medication review has been advocated as one of the measures to tackle the challenge of polypharmacy in older patients , yet there is no consensus on how best to evaluate its efficacy .
This study aim ed to assess outcome reporting in trials of medication review in older patients . | Background Throughout the literature , drug-related problems ( DRPs ) , such as medication reconciliation issues and potentially inappropriate prescribing , have been reported to be associated with adverse outcomes in older individuals . Both structured pharmacist review of medication ( SPRM ) interventions and computerized decision support systems ( CDSSs ) have been shown to reduce DRPs . Objective The objectives of this study were to ( i ) evaluate the impact of a specially developed SPRM/CDSS intervention on the appropriateness of prescribing in older Irish hospital in patients , and ( ii ) examine the acceptance rates of these recommendations . Methods We prospect ively review ed 361 patients , aged ≥65 years who were admitted to an Irish university teaching hospital over a 12-month period . At the point of admission , the patients received a SPRM/CDSS intervention , which screened for DRPs . Any DRPs that were identified were then communicated in writing to the attending medical team . The patient ’s medical records were review ed again at 7–10 days , or at the point of discharge ( whichever came first ) . Results Of the 361 patients review ed , 181 ( 50.1 % ) were female ; the median age was 77 years [ interquartile range ( IQR ) 71–83 years ) . A total of 3,163 ( median 9 , IQR 6–12 ) and 4,192 ( median 12 , IQR 8–15 ) medications were prescribed at admission and discharge , respectively . The SPRM generated 1,000 recommendations in 296 patients . Of the 1,000 recommendations , 548 ( 54.8 % ) were implemented by the medical teams accordingly . The SPRM/CDSS intervention result ed in an improvement in the appropriateness of prescribing as defined by the medication appropriateness index ( MAI ) , with a statistically significant difference in the median summated MAI at admission ( 15 , IQR : 7–21 ) and follow-up ( 12 , IQR : 6–18 ) ; p < 0.001 . However , the SPRM did not result in an improvement in appropriateness of underprescribing as defined by a modified set assessment of care of vulnerable elders ( ACOVE ) criteria . Conclusion This study indicated that DRPs are prevalent in older Irish hospitalized in patients and that a specially developed SPRM intervention supported by a CDSS can improve both the appropriateness and accuracy of medication regimens of older hospitalized in patients BACKGROUND Falls are the leading cause of both fatal and nonfatal injuries among older adults in the United States . Medications that affect the central nervous system are known to increase the risk of falling . OBJECTIVE The purpose of this study was to assess the effects of a community pharmacy-based falls-prevention program targeting high-risk older adults on the rates of recurrent falls , injurious falls , and filling prescriptions for medications that have been associated with an increased risk of falling . METHODS This was a r and omized controlled trial of participants recruited through a community pharmacy chain in North Carolina . The 2-year study consisted of a 1-year " look-back " period before r and omization and a 1-year follow-up period after r and omization . Patients were eligible to participate if they were ≥65 years of age , had fallen at least once during the 1-year period preceding enrollment , and were taking medications associated with an increased risk of falling . Medications classified as high risk included benzodiazepines , antidepressants , anticonvulsants , sedative hypnotics , opioid analgesics , antipsychotics , and skeletal muscle relaxants . Participants were assigned to either the intervention arm or the control arm ; participants in the intervention arm were invited to attend a face-to-face medication consultation conducted by a community pharmacy resident , whereas those in the control arm received no medication consultation . The primary end point was the rate of recurrent falls during the 1-year followup period . Secondary end points were the total number of prescriptions for high-risk medications filled during the follow-up period and either discontinued use or a reduction in the dosage of a high-risk medication during the follow-up period . RESULTS One hundred eighty-six patients ( 132 women , 54 men ; 88.7 % white ) were enrolled . Intention-to-treat ( ITT ) analyses revealed no significant differences in the rates of recurrent falls , injurious falls , or filling prescriptions for high-risk medications . However , 13 patients in the intervention group either discontinued use of a high-risk medication or had the dosage reduced during the follow-up period , compared with 5 patients in the control group ( χ(2 ) = 3.94 ; P < 0.05 ) . As-treated analyses revealed numeric reductions in the rates of falls ( rate ratio [ RR ] = 0.76 ; 95 % CI , 0.53 - 1.09 ) , injurious falls ( RR= 0.67 ; 95 % CI , 0.43 - 1.05 ) , and filling prescriptions for high-risk medications ( RR= 0.85 ; 95 % CI , 0.72 - 1.03 ) after receipt of the intervention , but the differences were not statistically significant . CONCLUSIONS Results of this study support the feasibility of using community pharmacies to deliver a falls-prevention program targeting high-risk older adults . Although the ITT analyses revealed no significant reduction in the rate of recurrent falls , injurious falls , or overall use of high-risk medications , individuals in the intervention group were more likely than those in the control group to discontinue use of a high-risk medication or have the dosage reduced during the 1-year follow-up period . More work is needed to evaluate the intervention using a larger sample size that provides greater power to detect clinical ly meaningful effects of reduction in the use of high-risk medications on preventing or reducing falls in the high-risk population OBJECTIVES to investigate the effectiveness of a pharmacy discharge plan in elderly hospitalized patients . DESIGN r and omized controlled trial . SUBJECTS AND SETTING S we r and omized patients aged 75 years and older on four or more medicines who had been discharged from three acute general and one long-stay hospital to a pharmacy intervention or usual care . INTERVENTIONS the hospital pharmacist developed discharge plans which gave details of medication and support required by the patient . A copy was given to the patient and to all relevant professionals and carers . This was followed by a domiciliary assessment by a community pharmacist . In the control group , patients were discharged from hospital following st and ard procedures that included a discharge letter to the general practitioner listing current medications . OUTCOMES the primary outcome was re-admission to hospital within 6 months . Secondary outcomes included the number of deaths , attendance at hospital outpatient clinics and general practice and proportion of days in hospital over the follow-up period , together with patients ' general well-being , satisfaction with the service and knowledge of and adherence to prescribed medication . RESULTS we recruited 362 patients , of whom 181 were r and omized to each group . We collected hospital and general practice data on at least 91 and 72 % of patients respectively at each follow-up point and interviewed between 43 and 90 % of the study subjects . There were no significant differences between the groups in the proportion of patients re-admitted to hospital between baseline and 3 months or 3 and 6 months . There were no significant differences in any of the secondary outcomes . CONCLUSIONS we found no evidence to suggest that the co-ordinated hospital and community pharmacy care discharge plans in elderly patients in this study influence outcomes OBJECTIVES To evaluate the effect of pharmaceutical care provided in addition to acute Geriatric Evaluation and Management ( GEM ) care on the appropriateness of prescribing . DESIGN R and omized , controlled trial , with the patient as unit of r and omization . SETTING Acute GEM unit . PARTICIPANTS Two hundred three patients aged 70 and older . INTERVENTION Pharmaceutical care provided from admission to discharge by a specialist clinical pharmacist who had direct contacts with the GEM team and patients . MEASUREMENTS Appropriateness of prescribing on admission , at discharge , and 3 months after discharge , using the Medication Appropriateness Index ( MAI ) , Beers criteria , and Assessing Care of Vulnerable Elders ( ACOVE ) underuse criteria and mortality , readmission , and emergency visits up to 12 months after discharge . RESULTS Intervention patients were significantly more likely than control patients to have an improvement in the MAI and in the ACOVE underuse criteria from admission to discharge ( odds ratio (OR)=9.1 , 95 % confidence interval (CI)=4.2 - 21.6 and OR=6.1 , 95 % CI=2.2 - 17.0 , respectively ) . The control and intervention groups had comparable improvements in the Beers criteria . CONCLUSION Pharmaceutical care provided in the context of acute GEM care improved the appropriate use of medicines during the hospital stay and after discharge . This is an important finding , because only limited data exist on the effect of various strategies to improve medication use in elderly in patients . The present approach has the potential to minimize risk and improve patient outcomes Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged Aim : To measure the outcomes of a harmonised , structured pharmaceutical care programme provided to elderly patients by community pharmacists . Method : A r and omised , controlled , longitudinal , clinical trial with repeated measures was performed over an 18‐month period , involving community pharmacies ( 5 intervention and 5 control ) in Northern Irel and . Elderly , ambulatory patients ( ≥ 65 years ) , taking 4 or more prescribed medications were eligible for participation . Patients attending an intervention pharmacy received education on medical conditions , implementation of compliance strategies , rationalising of drug regimens and appropriate monitoring ; patients attending control sites received normal services . A battery of clinical , humanistic and economic outcomes were assessed . Results : A significantly higher proportion of intervention patients were compliant at the end of the 18‐month study and experienced fewer problems with medication compared to control patients ( P < 0.05 ) . There was little impact on quality of life and health care utilisation . Conclusions : Pharmaceutical care provision to community‐dwelling patients result ed in an improvement in medication compliance and evidence of cost‐savings . Future pharmaceutical care studies may benefit from a more focussed selective approach to data collection and outcomes measurement OBJECTIVES to evaluate specialist geriatric input and medication review in patients in high-dependency continuing care . DESIGN prospect i ve , r and omised , controlled trial . SETTING two residential continuing care hospitals . PARTICIPANTS two hundred and twenty-five permanent patients . INTERVENTION patients were r and omised to either specialist geriatric input or regular input . The specialist group had a medical assessment by a geriatrician and medication review by a multidisciplinary expert panel . Regular input consisted of review as required by a medical officer attached to each ward . Re assessment occurred after 6 months . RESULTS one hundred and ten patients were r and omised to specialist input and 115 to regular input . These were comparable for age , gender , dependency levels and cognition . After 6 months , the total number of medications per patient per day fell from 11.64 to 11.09 in the specialist group ( P = 0.0364 ) and increased from 11.07 to 11.5 in the regular group ( P = 0.094 ) . There was no significant difference in mortality or frequency of acute hospital transfers ( 11 versus 6 in the specialist versus regular group , P = 0.213 ) . CONCLUSION specialist geriatric assessment and medication review in hospital continuing care result ed in a reduction in medication use , but at a significant cost . No benefits in hard clinical outcomes were demonstrated . However , qualitative benefits and lower costs may become evident over longer periods Purpose To examine the impact of systematic medication reconciliations upon hospital admission and of a medication review while in hospital on the number of inappropriate medications and unscheduled drug-related hospital revisits in elderly patients . Methods This was a prospect i ve , controlled study in 210 patients , aged 65 years or older , who were admitted to one of three internal medicine wards at a University Hospital in Sweden . Intervention patients received the complete Lund Integrated Medicines Management model ( medication reconciliation upon admission and discharge , and medication review and monitoring ) provided by a multi-professional team , including a clinical pharmacist . Control patients received st and ard care and medication reconciliation upon discharge . Blinded review ers evaluated the appropriateness of the prescribing ( using the Medication Appropriateness Index ) on admission and discharge , and assessed the probability that a drug-related problem was the reason for any patient readmitted to hospital or visiting the emergency department within 3 months of discharge ( using World Health Organisation causality criteria ) . Results There was a greater decrease in the number of inappropriate drugs in the intervention group than in the control group for both the intention-to-treat population { 51 % [ 95 % confidence interval ( CI ) 43–58 % ] vs. 39 % ( 95 % CI 30–48 % ) ; p = 0.0446 } and the per- protocol population [ 60 % ( 95 % CI 51–67 % ) vs. 44 % ( 95 % CI 34–52 % ) ; p = 0.0106 ) ] . There were six revisits to hospital in the intervention group which were judged as ‘ possibly , probably or certainly drug-related ’ , compared with 12 in the control group ( p = 0.0469 ) . Conclusions In this study , medication reconciliation and review provided by a clinical pharmacist in a multi-professional team significantly reduced the number of inappropriate drugs and unscheduled drug-related hospital revisits among elderly patients Background Patients at risk of falling are regularly prescribed medicines which increase falls risk . Medication review is a widely advocated risk reduction strategy . Objective The objectives of this descriptive study were to determine the number and types of falls risk medicines suitable for intervention , and to develop guidance to optimise the effectiveness of future medication related falls prevention initiatives . Setting An Irish acute teaching hospital and tertiary referral centre . Method 50 hospital in- patients at risk of falls underwent medication review focused on falls prevention by a pharmacist . Falls risk medicines were identified , and review ed . If scope to discontinue , dose reduce or switch to a safer alternative was identified by the pharmacist , the suggested medication changes were communicated to the patient ’s care team . Main outcome measure Identification of the classes of falls risk medicines and types of prescriptions with greatest potential for intervention . Results The mean number of falls risk medicines prescribed to each patient was 4.8 ( ±2.8 ) and the total number prescribed to the 50 patients was 238 . Following medication review , the pharmacist identified 48 ( 20 % ) as suitable for intervention . Consequently , 34 medication changes ( 70.8 % ) were implemented . Four medication classes accounted for over 80 % of medication changes . These were anti-emetics , opioid analgesics , anti-cholinergic agents acting on the bladder and benzodiazepines/hypnotics . Intervention was statistically significantly more likely to be possible in the case of p.r.n . medicines compared to regular medicines ( p < 0.001 , Chi square test ) . Medication review s focused on falls prevention took an average of 23.5 min per patient to complete . Conclusion Medication review s focused on falls prevention involve striking a balance between minimising medicines associated with falls and effectively treating medical conditions . We found only 20 % of falls risk medicines were suitable for change , and review s were time consuming and re source intensive . However , targeting four medication classes , and being particularly alert to the potential to discontinue ‘ as required ’ medicines , has the potential to achieve most of the benefits of more comprehensive review s. This information will guide the development of future falls risk medicine review initiatives in our hospital , increasing their feasibility in the acute hospital setting Abstract Objective : To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice . Design : R and omised controlled trial of clinical medication review by a pharmacist against normal general practice review . Setting : Four general practice s. Participants : 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community . Intervention : Patients were invited to a consultation at which the pharmacist review ed their medical conditions and current treatment . Main outcome measures : Number of changes to repeat prescriptions over one year , drug costs , and use of healthcare services . Results : 590 ( 97 % ) patients in the intervention group were review ed compared with 233 ( 44 % ) in the control group . Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions ( mean number of changes per patient 2.2 v 1.9 ; difference=0.31 , 95 % confidence interval 0.06 to 0.57 ; P=0.02 ) . Monthly drug costs rose in both groups over the year , but the rise was less in the intervention group ( mean difference £ 4.72 per 28 days , −£7.04 to -£2.41 ) ; equivalent to £ 61 per patient a year . Intervention patients had a smaller rise in the number of drugs prescribed ( 0.2 v 0.4 ; mean difference −0.2 , −0.4 to −0.1 ) . There was no evidence that review of treatment by the pharmacist affected practice consultation rates , outpatient consultations , hospital admissions , or death rate . Conclusions : A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs . Such review results in significant changes in patients ' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners . What is already known on this topic Review of patients on long term drug treatment is important but is done inadequately Evidence from the United States shows that pharmacists can improve patient care by review ing drug treatment What this study adds Consultations with a clinical pharmacist are an effective method of review ing the drug treatment of older patients Review by a pharmacist results in more drug changes and lower prescribing costs than normal care plus a much higher review rate Use of healthcare services by patients is not BACKGROUND Patients 80 years or older are underrepresented in scientific studies . The objective of this study was to investigate the effectiveness of interventions performed by ward-based pharmacists in reducing morbidity and use of hospital care among older patients . METHODS A r and omized controlled study of patients 80 years or older was conducted at the University Hospital of Uppsala , Uppsala , Sweden . Four hundred patients were recruited consecutively between October 1 , 2005 , and June 30 , 2006 , and were r and omized to control ( n = 201 ) and intervention ( n = 199 ) groups . The interventions were performed by ward-based pharmacists . The control group received st and ard care without direct involvement of pharmacists at the ward level . The primary outcome measure was the frequency of hospital visits ( emergency department and readmissions [ total and drug-related ] ) during the 12-month follow-up period . RESULTS Three hundred sixty-eight patients ( 182 in the intervention group and 186 in the control group ) were analyzed . For the intervention group , there was a 16 % reduction in all visits to the hospital ( quotient , 1.88 vs 2.24 ; estimate , 0.84 ; 95 % confidence interval [ CI ] , 0.72 - 0.99 ) and a 47 % reduction in visits to the emergency department ( quotient , 0.35 vs 0.66 ; estimate , 0.53 ; 95 % CI , 0.37 - 0.75 ) . Drug-related readmissions were reduced by 80 % ( quotient , 0.06 vs 0.32 ; estimate , 0.20 ; 95 % CI , 0.10 - 0.41 ) . After inclusion of the intervention costs , the total cost per patient in the intervention group was $ 230 lower than that in the control group . CONCLUSION If implemented on a population basis , the addition of pharmacists to health care teams would lead to major reductions in morbidity and health care costs Background Polypharmacy in the Swedish elderly population is currently a prioritised area of research with a focus on reducing the use of potentially inappropriate medications ( PIMs ) . Multi-professional interventions have previously been tested for their ability to improve drug therapy in frail elderly patients . Objective This study aim ed to assess a structured model for pharmacist-led medication review s in primary health care in southern Sweden and to measure its effects on numbers of patients with PIMs ( using the definition of the Swedish National Board of Health and Welfare ) using ≥10 drugs and using ≥3 psychotropics . Methods This study was a r and omised controlled clinical trial performed in a group of patients aged ≥75 years and living in nursing homes or the community and receiving municipal health care . Medication review s were performed by trained clinical pharmacists based on nurse-initiated symptom assessment s with team-based or distance feedback to the physician . Data were collected from the patients ’ electronic medication lists and medical records at baseline and 2 months after the medication review . Results A total of 369 patients were included : 182 in the intervention group and 187 in the control group . One-third of the patients in both groups had at least one PIM at baseline . Two months after the medication review s , the number of intervention group patients with at least one PIM and the number of intervention group patients using ten or more drugs had decreased ( p = 0.007 and p = 0.001 , respectively ) , while there were no statistically significant changes in the control patients . No changes were seen in the number of patients using three or more psychotropic drugs , although the dosages of these drugs tended to decrease . Drug-related problems ( DRPs ) were identified in 93 % of the 182 patients in the intervention group . In total , there were 431 DRPs in the intervention group ( a mean of 2.5 DRPs per patient , range 0–9 , SD 1.5 at 95 % CI ) and 16 % of the DRPs were related to PIMs . Conclusions Medication review s involving pharmacists in primary health care appear to be a feasible method to reduce the number of patients with PIMs , thus improving the quality of pharmacotherapy in elderly patients BACKGROUND regular medication review has been recommended for those over 75 and those on multiple drug therapy . Pharmacists are a potential source of assistance in review ing medication . Evidence of the benefits of this process is needed . OBJECTIVE to study the effect of medication review led by a pharmacist on resolution of pharmaceutical care issues , medicine costs , use of health and social services and health-related quality of life . DESIGN r and omized , controlled trial . SETTING general medical practice s in the Grampian region of Scotl and . SUBJECTS patients aged at least 65 years , with at least two chronic disease states who were taking at least four prescribed medicines regularly . METHODS pharmacists review ed the drug therapy of 332 patients , using information obtained from the practice computer , medical records and patient interviews . In 168 patients , a pharmaceutical care plan was then drawn up and implemented . The 164 control patients continued to receive normal care . All outcome measures were assessed at baseline and after 3 months . RESULTS all patients had at least two pharmaceutical care issues at baseline . Half of these were identified from the prescription record , the rest from notes and patient interview . Of all the issues , 21 % were resolved by information found in notes and 8.5 % by patient interview . General practitioners agreed with 96 % of all care issues documented on the care plans in the intervention group . At the time of follow-up , 70 % of the remaining care issues had been resolved in the intervention group , while only 14 % had been resolved in the control group . There were no changes in medicine costs or health-related quality of life in either group . There were small increases in contacts with health-care professionals and slightly fewer hospital admissions among the intervention group than the control group . CONCLUSIONS pharmacist-led medication review has the capacity to identify and resolve pharmaceutical care issues and may have some impact on the use of other health services BACKGROUND The impact of providing cognitive pharmacy services following hospital discharge has been studied with various results . This study is specifically focused on comprehensive medication management services delivered postdischarge in an interprofessional team environment to patients aged > 65 years . OBJECTIVE To determine if delivery of comprehensive medication management services postdischarge will prevent hospital readmissions or emergency department visits within 6 months following discharge in patients aged > 65 years . Secondary endpoints included 30-day and 60-day postdischarge events . METHODS This was a prospect i ve group matched-controlled study of patients aged > 65 years with selected diagnoses identified as high risk for readmission . The intervention group received comprehensive medication management that was provided face-to-face in the patient 's primary care clinic within 2 weeks of discharge . RESULTS No statistically significant difference was found between intervention and control groups in hospital readmissions or emergency department visits at 30 days , 60 days , or 6 months after discharge . No statistically significant difference was seen in mortality between groups . CONCLUSIONS Provision of comprehensive medication management services did not reduce emergency department visits or readmissions in this study . This study was limited by multiple other changes occurring in the health system during the time of this study that potentially confounded results . In addition , the study may have been too small to detect a difference BACKGROUND / PURPOSE Polypharmacy is common among Taiwanese older adults . We aim to determine the effectiveness of the medication safety review clinics ( MSRCs ) for solving drug-related problems ( DRPs ) among older adults prescribed multiple medications . METHODS This prospect i ve case-series intervention study was conducted at the outpatient department of the National Taiwan University Hospital and its BeiHu Branch . Older adults ( ≥65 years ) who either had been prescribed ≥8 chronic medications ( drugs prescribed for ≥28 days ) or had visited ≥3 different physicians during the 3-month screening period were enrolled ( N = 193 ) . DRPs were identified after baseline assessment s from a team of geriatricians and pharmacists . Prescribers were contacted with proposed interventions to be administered within 12 weeks . Problem-solving rates ( PSRs ) at both Week 12 and Week 24 visits were recorded . Stepwise multivariate logistic regression was applied to identify correlates of having at least one unsolved DRP at 24 weeks . Participants ( N = 139 ) who completed four visits to the MSRCs were analyzed . RESULTS The mean age was 75.6 ± 6.1 years and 56 % of them were men . The mean chronic medication per patient was 9.0 ± 3.1 , and the mean DRP per patient was 2.1 ± 1.5 . The PSR was 76 % at Week 12 and 87 % at Week 24 . Thirty-two patients ( 22 % ) had at least one unsolved DRP . Correlates of the unsolved DRP included a higher geriatric depression scale , a higher chronic medication per patient , and a higher DRP per patient . The mean chronic medication per patient ( 9.0 vs. 8.6 , p < 0.05 ) decreased , and the number of participants rating good or better health status improved from 22 % to 38 % in 24 weeks ( p < 0.001 ) . Participants were highly satisfied ( 96 % at all times ) with the service . CONCLUSION DRPs were common in geriatric out patients taking multiple medications and most were solved with appropriate interventions . The MSRC service may improve prescription quality in Taiwan if widely available Abstract Objective . To determine whether a pharmacist-led medications review in primary care reduces the number of drugs and the number of drug-related problems . Design . Prospect i ve r and omized controlled trial . Setting . Liljeholmen Primary Care Centre , Stockholm , Sweden . Subjects . 209 patients aged ≥ 65 years with five or more different medications . Intervention . Patients answered a question naire regarding medications . The pharmacist review ed all medications ( prescription , non-prescription , and herbal ) regarding recommendations and renal impairment , giving advice to patients and GPs . Each patient met the pharmacist before seeing their GP . Control patients received their usual care . Main outcome measures . Drug-related problems and number of drugs . Secondary outcomes included health care utilization and self-rated health during 12 months of follow-up . Results . No significant difference was seen when comparing change in drug-related problems between the groups . However , a significant decrease in drug-related problems was observed in the intervention group ( from 1.73 per patient at baseline to 1.31 at follow-up , p < 0.05 ) . The change in number of drugs was more pronounced in the intervention group ( p < 0.046 ) . Intervention group patients were not admitted to hospital on fewer occasions or for fewer days , and there was no significant difference between the two groups regarding utilization of primary care during follow-up . Self-rated health remained unchanged in the intervention group , whereas a drop ( p < 0.02 ) was reported in the control group . This result ed in a significant difference in change in self-rated health between the groups ( p < 0.047 ) . Conclusions . The addition of a skilled pharmacist to the primary care team may contribute to reductions in numbers of drugs and maintenance of self-rated health in elderly patients with polypharmacy Objective To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic review s. Design Cohort study of systematic review s from two data bases . Setting Outcome reporting bias in trials for harm outcomes ( ORBIT II ) in systematic review s from the Cochrane Library and a separate cohort of systematic review s of adverse events . Participants 92 systematic review s of r and omised controlled trials and non-r and omised studies published in the Cochrane Library between issue 9 , 2012 and issue 2 , 2013 ( Cochrane cohort ) and 230 systematic review s published between 1 January 2007 and 31 December 2011 in other publications , synthesis ing data on harm outcomes ( adverse event cohort ) . Methods A 13 point classification system for missing outcome data on harm was developed and applied to the studies . Results 86 % ( 79/92 ) of review s in the Cochrane cohort did not include full data from the main harm outcome of interest of each review for all of the eligible studies included within that review ; 76 % ( 173/230 ) for the adverse event cohort . Overall , the single primary harm outcome was inadequately reported in 76 % ( 705/931 ) of the studies included in the 92 review s from the Cochrane cohort and not reported in 47 % ( 4159/8837 ) of the 230 review s in the adverse event cohort . In a sample of primary studies not reporting on the single primary harm outcome in the review , scrutiny of the study publication revealed that outcome reporting bias was suspected in nearly two thirds ( 63 % , 248/393 ) . Conclusions The number of review s suspected of outcome reporting bias as a result of missing or partially reported harm related outcomes from at least one eligible study is high . The declaration of important harms and the quality of the reporting of harm outcomes must be improved in both primary studies and systematic review BACKGROUND Pharmacists can improve patient outcomes in institutional and pharmacy setting s , but little is known about their effectiveness as consultants to primary care physicians . We examined whether an intervention by a specially trained pharmacist could reduce the number of daily medication units taken by elderly patients , as well as costs and health care use . METHODS We conducted a r and omized controlled trial in family practice s in 24 sites in Ontario . We r and omly allocated 48 r and omly selected family physicians ( 69.6 % participation rate ) to the intervention or the control arm , along with 889 ( 69.5 % participation rate ) of their r and omly selected community-dwelling , elderly patients who were taking 5 or more medications daily . In the intervention group , pharmacists conducted face-to-face medication review s with the patients and then gave written recommendations to the physicians to resolve any drug-related problems . Process outcomes included the number of drug-related problems identified among the senior citizens in the intervention arm and the proportion of recommendations implemented by the physicians . RESULTS After 5 months , seniors in the intervention and control groups were taking a mean of 12.4 and 12.2 medication units per day respectively ( p = 0.50 ) . There were no statistically significant differences in health care use or costs between groups . A mean of 2.5 drug-related problems per senior was identified in the intervention arm . Physicians implemented or attempted to implement 72.3 % ( 790/1093 ) of the recommendations . INTERPRETATION The intervention did not have a significant effect on patient outcomes . However , physicians were receptive to the recommendations to resolve drug-related problems , suggesting that collaboration between physicians and pharmacists is feasible OBJECTIVES To test the effect of an adapted U.S. model of pharmaceutical care on prescribing of inappropriate psychoactive ( anxiolytic , hypnotic , and antipsychotic ) medications and falls in nursing homes for older people in Northern Irel and ( NI ) . DESIGN Cluster r and omized controlled trial . SETTING Nursing homes r and omized to intervention ( receipt of the adapted model of care ; n=11 ) or control ( usual care continued ; n=11 ) . PARTICIPANTS Residents aged 65 and older who provided informed consent ( N=334 ; 173 intervention , 161 control ) . INTERVENTION Specially trained pharmacists visited intervention homes monthly for 12 months and review ed residents ' clinical and prescribing information , applied an algorithm that guided them in assessing the appropriateness of psychoactive medication , and worked with prescribers ( general practitioners ) to improve the prescribing of these drugs . The control homes received usual care . MEASUREMENTS The primary end point was the proportion of residents prescribed one or more inappropriate psychoactive medicine according to st and ardized protocol s ; falls were evaluated using routinely collected falls data m and ated by the regulatory body for nursing homes in NI . RESULTS The proportion of residents taking inappropriate psychoactive medications at 12 months in the intervention homes ( 25/128 , 19.5 % ) was much lower than in the control homes ( 62/124 , 50.0 % ) ( odds ratio=0.26 , 95 % confidence interval=0.14 - 0.49 ) after adjustment for clustering within homes . No differences were observed at 12 months in the falls rate between the intervention and control groups . CONCLUSION Marked reductions in inappropriate psychoactive medication prescribing in residents result ed from pharmacist review of targeted medications , but there was no effect on falls OBJECTIVE To investigate the effectiveness of an educational Quality Use of Medicines program , delivered at the level of general practice , on medicines use , falls and quality of life in people aged > or = 65 years . DESIGN Cluster r and omised controlled trial conducted in 2002 . SETTING General practice s in the Hunter Region , New South Wales , Australia . PARTICIPANTS Twenty general practitioners recruited 849 patients to participate in the study . INTERVENTION Education ( academic detailing , provision of prescribing information and feedback ) ; medication risk assessment ; facilitation of medication review ; financial incentives . MAIN OUTCOME MEASURES PRIMARY MEASURES a composite score reflecting use of benzodiazepines , non-steroidal anti-inflammatory drugs ( NSAIDs ) and thiazide diuretics ; secondary measures : use of medication review s , occurrence of falls , quality of life ( as assessed by SF-12 and EQ-5D survey scores . RESULTS Compared with the control group , participants in the intervention group had increased odds of having an improved medication use composite score ( odds ratio [ OR ] , 1.86 ; 95 % CI , 1.21 - 2.85 ) at 4-month follow-up but not at 12 months . At 4-month follow-up , the intervention group had reduced odds of using NSAIDs ( OR , 0.62 ; 95 % CI , 0.39 - 0.99 ) and showed a non-significant reduction in use of benzodiazepines ( OR , 0.51 ; 95 % CI , 0.20 - 1.30 ) and thiazide diuretics ( OR , 0.70 ; 95 % CI , 0.48 - 1.01 ) . Changes in drug use were not significant at 12-month follow-up . At 12 months , intervention-group participants had lower adjusted ORs ( AORs ) for having a fall ( AOR , 0.61 ; 95 % CI , 0.41 - 0.91 ) , injury ( AOR , 0.56 ; 95 % CI , 0.32 - 0.96 ) , and injury requiring medical attention ( AOR , 0.46 ; 95 % CI , 0.30 - 0.70 ) . Quality -of-life scores were unaffected by the intervention . CONCLUSION Education and systems for medication review conducted by GPs can be used to improve use of medicines . These interventions are associated with a reduction in falls among older people , without adverse effects on quality of life Abstract Objective To ascertain the current burden of adverse drug reactions ( ADRs ) through a prospect i ve analysis of all admissions to hospital . Design Prospect i ve observational study . Setting Two large general hospitals in Merseyside , Engl and . Participants 18 820 patients aged > 16 years admitted over six months and assessed for cause of admission . Main outcome measures Prevalence of admissions due to an ADR , length of stay , avoidability , and outcome . Results There were 1225 admissions related to an ADR , giving a prevalence of 6.5 % , with the ADR directly leading to the admission in 80 % of cases . The median bed stay was eight days , accounting for 4 % of the hospital bed capacity . The projected annual cost of such admissions to the NHS is £ 466 m ( € 706 m , $ 847 m ) . The overall fatality was 0.15 % . Most reactions were either definitely or possibly avoidable . Drugs most commonly implicated in causing these admissions included low dose aspirin , diuretics , warfarin , and non-steroidal anti-inflammatory drugs other than aspirin , the most common reaction being gastrointestinal bleeding . Conclusion The burden of ADRs on the NHS is high , accounting for considerable morbidity , mortality , and extra costs . Although many of the implicated drugs have proved benefit , measures need to be put into place to reduce the burden of ADRs and thereby further improve the benefit : harm ratio of the drugs OBJECTIVES To assess the effect of a Screening Tool of Older Persons potentially inappropriate Prescriptions/Screening Tool to Alert doctors to Right Treatment ( STOPP/START ) medication intervention on clinical and economic outcomes . DESIGN Parallel-group r and omized trial . SETTING Chronic care geriatric facility . PARTICIPANTS Residents aged 65 and older prescribed with at least one medication ( N = 359 ) were r and omized to receive usual pharmaceutical care or undergo medication intervention . INTERVENTION Screening medications with STOPP/START criteria followed up with recommendations to the chief physician . MEASUREMENTS The outcome measures assessed at the initiation of the intervention and 1 year later were number of hospitalizations and falls , Functional Independence Measure ( FIM ) , quality of life ( measured using the Medical Outcomes Study 12-item Short-Form Health Survey ) , and costs of medications . RESULTS The average number of drugs prescribed was significantly lower in the intervention than in the control group after 1 year ( P < .001 ) . The average drug costs in the intervention group decreased by 103 shekels ( US$ 29 ) per participant per month ( P < .001 ) . The average number of falls in the intervention group dropped significantly ( P = .006 ) . Rates of hospitalization , FIM scores , and quality of life measurements were similar for both groups . CONCLUSION Implementation of STOPP/START criteria reduced the number of medications , falls , and costs in a geriatric facility . Their incorporation in those and similar setting s is recommended AIMS To evaluate whether a year long clinical pharmacy program involving development of professional relationships , nurse education on medication issues , and individualized medication review s could change drug use , mortality and morbidity in nursing home residents . METHODS A cluster r and omised controlled trial , where an intervention home was matched to three control homes , was used to examine the effect of the clinical pharmacy intervention on resident outcomes . The study involved 905 residents in 13 intervention nursing homes and 2325 residents in 39 control nursing homes in south-east Queensl and and north-east New South Wales , Australia . The outcome measures were : continuous drug use data from government prescription subsidy cl aims , cross-sectional drug use data on prescribed and administered medications , deaths and morbidity indices ( hospitalization rates , adverse events and disability indices ) . RESULTS This intervention result ed in a reduction in drug use with no change in morbidity indices or survival . Differences in nursing home characteristics , as defined by cluster analysis with SUDAAN , negated intervention-related apparent significant improvements in survival . The use of benzodiazepines , nonsteroidal anti-inflammatory drugs , laxatives , histamine H2-receptor antagonists and antacids was significantly reduced in the intervention group , whereas the use of digoxin and diuretics remained similar to controls . Overall , drug use in the intervention group was reduced by 14.8 % relative to the controls , equivalent to an annual prescription saving of A64 dollars per resident ( approximately 25 pound sterling ) . CONCLUSIONS This intervention improved nursing home resident outcomes related to changes in drug use and drug-related expenditure . The continuing divergence in both drug use and survival at the end of the study suggests that the difference would have been more significant in a larger and longer study , and even more so using additional instruments specific for measuring outcomes related to changes in drug use BACKGROUND Aged Care Assessment Teams ( ACATs ) in Australia assess the care needs of frail older people . Despite being at high risk of medication-related problems ( MRPs ) , ACAT patients do not routinely receive a comprehensive medication review . OBJECTIVES The aims of the study were to compare three methods for facilitating a pharmacist-led comprehensive medication review for people referred to an ACAT , and compare MRPs identified via ACAT usual care with those identified via pharmacist-led medication review s. METHODS A prospect i ve , r and omized , comparative study involving 80 community-dwelling patients ( median age 84 years ) referred to an ACAT in Melbourne , Australia , was conducted . Following ACAT assessment ( usual care ) , a clinical pharmacist review ed all participating patients ' ACAT files to identify potential MRPs not identified by the ACAT ( medication review method 1 ) . Patients were then r and omized into two groups . Group A received information about the Australian government-funded , general practitioner (GP)-initiated Home Medicines Review ( HMR ) programme , and a letter was sent to their GP recommending an HMR ( GPHMR ; medication review method 2 ) . Group B patients were referred directly to a clinical pharmacist associated with the ACAT for an ACAT-initiated pharmacist home medicines review ( APHMR ; medication review method 3 ) ; the pharmacist arranged a home visit , obtained a thorough medication history and conducted a comprehensive medication review . The main outcome measures were the proportion of patients who received a pharmacist home visit within 28 days ; the number of MRPs identified by ACAT usual care , pharmacist review of ACAT files , and APHMR , and their clinical risk ( assessed by a geriatrician-pharmacist panel ) ; and patients ' , GPs ' and ACAT clinicians ' opinions about pharmacist medication review . RESULTS Three hundred patients were referred to the ACAT , and 80 were recruited into the study . Thirty-six of 40 APHMR patients ( 90.0 % ) received a pharmacist home visit within 28 days , compared with 7/40 GPHMR patients (17.5%).[p < 0.001 ] . Twenty-one MRPs were identified via ACAT usual care . Pharmacist review of ACAT files identified a further 164 potential MRPs ( median 2.0 per patient ; inter-quartile range [ IQR ] 1.0 - 3.0 ) ; however , in patients who received an APHMR , 35/82 potential MRPs ( 42.7 % ) turned out not to be actual problems , most commonly because of discrepancies between the patient 's ACAT medication list and the medications currently being used by the patient ( median 3.0 discrepancies per patient ; IQR 2.0 - 5.5 ) . APHMR identified a further 79 MRPs ( median 2.0 ; IQR 1.0 - 3.0 ) . One hundred and twenty-two MRPs were included in APHMR reports sent to patients ' GPs . Of these , 94 ( 77.0 % ) were assessed as being associated with a moderate , high or extreme risk of an adverse event . Sixty-four APHMR recommendations ( 52.5 % ) led to changes to patients ' medication regimens or medication management . Thirty-six of 39 GPs ( 92.3 % ) who provided feedback reported that pharmacist medication review s were useful . Patients ( or their carers ) also reported that pharmacist home visits were useful : median rating 4.25 out of 5 ( IQR 4.0 - 5.0 ) . Seven of 11 ACAT clinicians ( 77.8 % ) agreed that pharmacist-led medication review should be a st and ard component of ACAT assessment s. CONCLUSIONS ACAT assessment s without pharmacist involvement detected fewer MRPs than any of the evaluated pharmacist-led medication review methods . APHMR was more effective than pharmacist review of routinely collected ACAT data , and more reliable and timely than referral to the patients ' GP for a GPHMR BACKGROUND Systematic review s may be compromised by selective inclusion and reporting of outcomes and analyses . Selective inclusion occurs when there are multiple effect estimates in a trial report that could be included in a particular meta- analysis ( e.g. from multiple measurement scales and time points ) and the choice of effect estimate to include in the meta- analysis is based on the results ( e.g. statistical significance , magnitude or direction of effect ) . Selective reporting occurs when the reporting of a subset of outcomes and analyses in the systematic review is based on the results ( e.g. a protocol -defined outcome is omitted from the published systematic review ) . OBJECTIVES To summarise the characteristics and synthesis e the results of empirical studies that have investigated the prevalence of selective inclusion or reporting in systematic review s of r and omised controlled trials ( RCTs ) , investigated the factors ( e.g. statistical significance or direction of effect ) associated with the prevalence and quantified the bias . SEARCH METHODS We search ed the Cochrane Methodology Register ( to July 2012 ) , Ovid MEDLINE , Ovid EMBASE , Ovid PsycINFO and ISI Web of Science ( each up to May 2013 ) , and the US Agency for Healthcare Research and Quality ( AHRQ ) Effective Healthcare Program 's Scientific Re source Center ( SRC ) Methods Library ( to June 2013 ) . We also search ed the abstract books of the 2011 and 2012 Cochrane Colloquia and the article alerts for method ological work in research synthesis published from 2009 to 2011 and compiled in Research Synthesis Methods . SELECTION CRITERIA We included both published and unpublished empirical studies that investigated the prevalence and factors associated with selective inclusion or reporting , or both , in systematic review s of RCTs of healthcare interventions . We included empirical studies assessing any type of selective inclusion or reporting , such as investigations of how frequently RCT outcome data is selectively included in systematic review s based on the results , outcomes and analyses are discrepant between protocol and published review or non-significant outcomes are partially reported in the full text or summary within systematic review s. DATA COLLECTION AND ANALYSIS Two review authors independently selected empirical studies for inclusion , extracted the data and performed a risk of bias assessment . A third review author resolved any disagreements about inclusion or exclusion of empirical studies , data extraction and risk of bias . We contacted authors of included studies for additional unpublished data . Primary outcomes included overall prevalence of selective inclusion or reporting , association between selective inclusion or reporting and the statistical significance of the effect estimate , and association between selective inclusion or reporting and the direction of the effect estimate . We combined prevalence estimates and risk ratios ( RRs ) using a r and om-effects meta- analysis model . MAIN RESULTS Seven studies met the inclusion criteria . No studies had investigated selective inclusion of results in systematic review s , or discrepancies in outcomes and analyses between systematic review registry entries and published systematic review s. Based on a meta- analysis of four studies ( including 485 Cochrane Review s ) , 38 % ( 95 % confidence interval ( CI ) 23 % to 54 % ) of systematic review s added , omitted , up grade d or down grade d at least one outcome between the protocol and published systematic review . The association between statistical significance and discrepant outcome reporting between protocol and published systematic review was uncertain . The meta-analytic estimate suggested an increased risk of adding or upgrading ( i.e. changing a secondary outcome to primary ) when the outcome was statistically significant , although the 95 % CI included no association and a decreased risk as plausible estimates ( RR 1.43 , 95 % CI 0.71 to 2.85 ; two studies , n = 552 meta-analyses ) . Also , the meta-analytic estimate suggested an increased risk of downgrading ( i.e. changing a primary outcome to secondary ) when the outcome was statistically significant , although the 95 % CI included no association and a decreased risk as plausible estimates ( RR 1.26 , 95 % CI 0.60 to 2.62 ; two studies , n = 484 meta-analyses ) . None of the included studies had investigated whether the association between statistical significance and adding , upgrading or downgrading of outcomes was modified by the type of comparison , direction of effect or type of outcome ; or whether there is an association between direction of the effect estimate and discrepant outcome reporting . Several secondary outcomes were reported in the included studies . Two studies found that reasons for discrepant outcome reporting were infrequently reported in published systematic review s ( 6 % in one study and 22 % in the other ) . One study ( including 62 Cochrane Review s ) found that 32 % ( 95 % CI 21 % to 45 % ) of systematic review s did not report all primary outcomes in the abstract . Another study ( including 64 Cochrane and 118 non-Cochrane review s ) found that statistically significant primary outcomes were more likely to be completely reported in the systematic review abstract than non-significant primary outcomes ( RR 2.66 , 95 % CI 1.81 to 3.90 ) . None of the studies included systematic review s published after 2009 when reporting st and ards for systematic review s ( Preferred Reporting Items for Systematic review s and Meta-Analyses ( PRISMA ) Statement , and Method ological Expectations of Cochrane Intervention Review s ( MECIR ) ) were disseminated , so the results might not be generalisable to more recent systematic review s. AUTHORS ' CONCLUSIONS Discrepant outcome reporting between the protocol and published systematic review is fairly common , although the association between statistical significance and discrepant outcome reporting is uncertain . Complete reporting of outcomes in systematic review abstract s is associated with statistical significance of the results for those outcomes . Systematic review outcomes and analysis plans should be specified prior to seeing the results of included studies to minimise post-hoc decisions that may be based on the observed results . Modifications that occur once the review has commenced , along with their justification , should be clearly reported . Effect estimates and CIs should be reported for all systematic review outcomes regardless of the results . The lack of research on selective inclusion of results in systematic review s needs to be addressed and studies that avoid the method ological weaknesses of existing research are also needed Objective We investigated the health-related effect of systematic medication review performed by a clinical pharmacist and a clinical pharmacologist on nonelective elderly orthopedic patients . Methods This is a nonblinded r and omized controlled study of 108 patients 65 years or older treated with at least 4 drugs . For the intervention , the clinical pharmacist review ed the participants ' medication after completion of the usual medication routine . Information was collected from medical charts , interviews with participants , and data base registration s of drug purchase . Results were conferred with the clinical pharmacologist , and recommendations were delivered directly to the ward physicians . The control was usual medication routine , that is , physicians prescribing admitting orders . The primary outcome was time to the first unplanned contact to a physician after discharge ( i.e. , general practitioner , emergency department visit , or readmission ) during 3-month follow-up . Secondary outcomes included other health-related outcomes , for example , length of in-hospital stay , mortality , and quality of life . Results Time to the first unplanned contact to a physician was 14.9 days ( 95 % confidence interval , 8.9–21.0 ) in the intervention group compared with 27.3 days ( 95 % confidence interval , 18.9–35.7 ) in the controls ( P = 0.05 ) . Overall , no statistically significant differences were seen in the secondary outcomes apart from “ number of ” and “ time to first ” emergency department visits , which were in favor of the intervention group . A marked hesitation of the ward physicians to comply with recommendations was noted ( 18 % ) . Conclusions The study showed that the patients receiving usual care had a significantly longer time to the first unplanned contact to a physician after discharge ; however , the fact that less than 1 of 5 recommendations was adopted by the physicians raises concerns as to whether this finding could be attributable to the intervention Elderly patients are vulnerable to medication errors and adverse drug events due to increased morbidity , polypharmacy and inappropriate interactions . The objective of this study was to investigate whether systematic medication review and counselling performed by a clinical pharmacist and clinical pharmacologist would reduce length of in-hospital stay in elderly patients admitted to an acute ward of internal medicine . A r and omized , controlled study of 100 patients aged 70 years or older was conducted in an acute ward of internal medicine in Denmark . Intervention arm : a clinical pharmacist conducted systematic medication review s after an experienced medical physician had prescribed the patients ' medication . Information was collected from medical charts , interview with the patients and data base registration s of drug purchase . Subsequently , medication histories were conferred with a clinical pharmacologist and advisory notes recommending medication changes were completed . Physicians were not obliged to comply with the recommendations . Control arm : medication was review ed by usual routine in the ward . Primary end-point was length of in-hospital stay . In addition , readmissions , mortality , contact to primary healthcare and quality of life were measured at 3-month follow-up . In the intervention arm , the mean length of in-hospital stay was 239.9 hr ( 95 % CI : 190.2 - 289.6 ) and in the control arm : 238.6 hr ( 95 % CI : 137.6 - 339.6 ) , which was neither a statistical significant nor a clinical ly relevant difference . Moreover , no differences were observed for any of the secondary end-points . Systematic medication review and medication counselling did not show any effect on in-hospital length of stay in elderly patients when admitted to an acute ward of internal medicine OBJECTIVE to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents . DESIGN r and omised controlled trial of clinical medication review by a pharmacist against usual care . SETTING sixty-five care homes for the elderly in Leeds , UK . PARTICIPANTS a total of 661 residents aged 65 + years on one or more medicines . INTERVENTION clinical medication review by a pharmacist with patient and clinical records . Recommendations to general practitioner for approval and implementation . Control patients received usual general practitioner care . MAIN OUTCOME MEASURES primary : number of changes in medication per participant . Secondary : number and cost of repeat medicines per participant ; medication review rate ; mortality , falls , hospital admissions , general practitioner consultations , Barthel index , St and ardised Mini-Mental State Examination ( SMMSE ) . RESULTS the pharmacist review ed 315/331 ( 95.2 % ) patients in 6 months . A total of 62/330 ( 18.8 % ) control patients were review ed by their general practitioner . The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group ( P < 0.0001 ) . There were respectively 0.8 and 1.3 falls per patient ( P < 0.0001 ) . There was no significant difference for GP consultations per patient ( means 2.9 and 2.8 in 6 months , P = 0.5 ) , hospitalisations ( means 0.2 and 0.3 , P = 0.11 ) , deaths ( 51/331 and 48/330 , P = 0.81 ) , Barthel score ( 9.8 and 9.3 , P = 0.06 ) , SMMSE score ( 13.9 and 13.8 , P = 0.62 ) , number and cost of drugs per patient ( 6.7 and 6.9 , P = 0.5 ) ( pounds sterling 42.24 and pounds sterling 42.94 per 28 days ) . A total of 75.6 % ( 565/747 ) of pharmacist recommendations were accepted by the general practitioner ; and 76.6 % ( 433/565 ) of accepted recommendations were implemented . CONCLUSIONS general practitioners do not review most care home patients ' medication . A clinical pharmacist can review them and make recommendations that are usually accepted . This leads to substantial change in patients ' medication regimens without change in drug costs . There is a reduction in the number of falls . There is no significant change in consultations , hospitalisation , mortality , SMMSE or Barthel scores Aim of study : This study sought to determine whether multidisciplinary case conference review s improved outcomes for nursing home residents , and the effects of this team approach to resident care on carers , including the h and s-on carers employed by the nursing home , and health professionals . Method : 245 residents of three Canberra nursing homes were enrolled in this non-r and omised controlled trial . The intervention consisted of sessions of three case conference review s held between 10/4sol;96 and 4sol;12sol;96 . These sessions were attended by the General Practitioners ( GPs ) of the residents discussed , the GP project officer from the ACT Division of General Practice , a clinical pharmacist , senior nursing staff , other health professionals eg physiotherapist , and occasionally the resident concerned or their representative . At each review , a case presentation by the resident 's GP was followed by a multidisciplinary discussion of all aspects , medical and non-medical , of the resident 's care . The review concluded with a management plan for the resident . In total 75 residents were review ed . Main outcome measures : Medication use and cost , and mortality . Results : One month after the review s were completed comparisons between those who were review ed and those who were not showed non-significant reductions in medication orders , medication cost , and mortality in the review ed group . Many of the 92 recommendations in the management plans that were carried out benefited the residents ( n=37 ) and /or carers ( n=24 ) . The responses of the GPs and the Directors of Nursing to the review s were overwhelmingly positive . Conclusion : Recommendations arising from multidisciplinary case conferences were carried out to the benefit of patients and carers . Given the support shown by key stakeholders , multidisciplinary conferences should be used more Purpose To evaluate if nurses after receiving training in clinical pharmacology can improve the quality of the drug therapy in elderly hospitalized patients . Methods Nurses were given a 1-day training in clinical pharmacology to identify drug-related problems ( DRPs ) . All patients admitted to the ward aged 65 or more were studied . Patients at the same ward before the intervention were considered as control group . Outcome variables were re-hospitalized 3 months from discharge , drug-related re-admissions , the proportion of inappropriate drug use ( IDU ) , and DRPs found by the nurses . Results Of 460 patients ( 250 intervention group and 210 in the control group ) 38 and 36 % , respectively , had at least one re-admission to hospital ( p = 0.86 ) and 24 % of the patients died . Eighteen and 17 % ( 43/37 ) , respectively , used one or more inappropriate drug ( p 0.90 ) . The nurses found 86 clinical ly significant DRPs not detected by the usual care . A substantial part of the DRPs detected by the nurses were revealed with assistance of Symptoms Assessment Form ( SYM ) . There were no statistical difference in the number of drug-related re-admissions between the groups , 14/16 , respectively , ( p = 0.40 ) . Conclusions Nurses are able to detect a high proportion of clinical ly relevant DRPs not detected by the usual care and thereby increase the quality of the drug treatment in elderly hospitalized patients . Our study showed no effect on re-hospitalization or IDU . By using a SYM nurses can find DRPs that computer-based decision support systems miss OBJECTIVES To determine the extent to which the use of a clinical informatics tool that implements prospect i ve monitoring plans reduces the incidence of potential delirium , falls , hospitalizations potentially due to adverse drug events , and mortality . DESIGN R and omized cluster trial . SETTING Twenty-five nursing homes serviced by two long-term care pharmacies . PARTICIPANTS Residents living in nursing homes during 2003 ( 1,711 in 12 intervention ; 1,491 in 13 usual care ) and 2004 ( 1,769 in 12 intervention ; 1,552 in 13 usual care ) . INTERVENTION The pharmacy automatically generated Geriatric Risk Assessment MedGuide ( GRAM ) reports and automated monitoring plans for falls and delirium within 24 hours of admission or as part of the normal time frame of federally m and ated drug regimen review . MEASUREMENTS Incidence of potential delirium , falls , hospitalizations potentially due to adverse drug events , and mortality . RESULTS GRAM triggered monitoring plans for 491 residents . Newly admitted residents in the intervention homes experienced a lower rate of potential delirium onset than those in usual care homes ( adjusted hazard ratio (HR)=0.42 , 95 % confidence interval (CI)=0.35 - 0.52 ) , overall hospitalization ( adjusted HR=0.89 , 95 % CI=0.72 - 1.09 ) , and mortality ( adjusted HR=0.88 , 95 % CI=0.66 - 1.16 ) . In longer stay residents , the effects of the intervention were attenuated , and all estimates included unity . CONCLUSION Using health information technology in long-term care pharmacies to identify residents who might benefit from the implementation of prospect i ve medication monitoring care plans when complex medication regimens carry potential risks for falls and delirium may reduce adverse effects associated with appropriate medication use PURPOSE To determine if inpatient or outpatient geriatric evaluation and management , as compared with usual care , reduces adverse drug reactions and suboptimal prescribing in frail elderly patients . METHODS The study employed a r and omized 2 x 2 factorial controlled design . Subjects were patients in 11 Veterans Affairs ( VA ) hospitals who were > or = 65 years old and met criteria for frailty ( n = 834 ) . Inpatient geriatric unit and outpatient geriatric clinic teams evaluated and managed patients according to published guidelines and VA st and ards . Patients were followed for 12 months . Blinded physician-pharmacist pairs rated adverse drug reactions for causality ( using Naranjo 's algorithm ) and seriousness . Suboptimal prescribing measures included unnecessary and inappropriate drug use ( Medication Appropriateness Index ) , inappropriate drug use ( Beers criteria ) , and underuse . RESULTS For serious adverse drug reactions , there were no inpatient geriatric unit effects during the inpatient or outpatient follow-up periods . Outpatient geriatric clinic care result ed in a 35 % reduction in the risk of a serious adverse drug reaction compared with usual care ( adjusted relative risk = 0.65 ; 95 % confidence interval : 0.45 to 0.93 ) . Inpatient geriatric unit care reduced unnecessary and inappropriate drug use and underuse significantly during the inpatient period ( P < 0.05 ) . Outpatient geriatric clinic care reduced the number of conditions with omitted drugs significantly during the outpatient period ( P < 0.05 ) . CONCLUSION Compared with usual care , outpatient geriatric evaluation and management reduces serious adverse drug reactions , and inpatient and outpatient geriatric evaluation and management reduces suboptimal prescribing , in frail elderly patients Inappropriate prescribing is particularly common in older patients and is associated with adverse drug events ( ADEs ) , hospitalization , and wasteful utilization of re sources . We r and omized 400 hospitalized patients aged ≥65 years to receive either the usual pharmaceutical care ( control ) or screening with STOPP/START criteria followed up with recommendations to their attending physicians ( intervention ) . The Medication Appropriateness Index ( MAI ) and Assessment of Underutilization ( AOU ) index were used to assess prescribing appropriateness , both at the time of discharge and for 6 months after discharge . Unnecessary polypharmacy , the use of drugs at incorrect doses , and potential drug – drug and drug – disease interactions were significantly lower in the intervention group at discharge ( absolute risk reduction 35.7 % , number needed to screen to yield improvement in MAI = 2.8 ( 95 % confidence interval 2.2–3.8 ) ) . Underutilization of clinical ly indicated medications was also reduced ( absolute risk reduction 21.2 % , number needed to screen to yield reduction in AOU = 4.7 ( 95 % confidence interval 3.4–7.5 ) ) . Significant improvements in prescribing appropriateness were sustained for 6 months after discharge OBJECTIVE To assess whether home-based medication review by a pharmacist for at-risk older patients in a primary care setting can reduce hospital admissions . DESIGN R and omised controlled trial comparing home-based medication review with st and ard care . SETTING Home-based medication review of 136 patients registered with one general practice . METHOD Study participants were over 80 years of age , living at home , taking four or more medicines , and had at least one additional medicines-related risk factor . The intervention comprised two home visits by a community pharmacist who educated the patient/carer about their medicines , noted any pharmaceutical care issues , assessed need for an adherence aid , and subsequently met with the lead GP to agree on actions . MAIN OUTCOME MEASURE Total non-elective hospital admissions within 6 months . Secondary outcomes included number of deaths , care home admissions and quality of life ( EQ-5d ) . Impact on number of medicines prescribed was also assessed . RESULTS At 6 months , no difference in hospital admissions ( 21 intervention versus 20 control P = 0.80 ) , and no difference in care home admissions or deaths were detected between groups . There was a small ( non-significant ) decrease in quality of life in the intervention group . There was a statistically significant reduction in the mean number of medicines prescribed ( -0.87 items in favour of the intervention group , 95 % confidence interval -1.66 to -0.08 , P = 0.03 ) . CONCLUSIONS No positive impact on clinical outcomes or quality of life was demonstrated , however , this intervention did appear to reduce prescribing . This is in line with other evidence and suggests that this form of intervention may not have a clear health gain , but may lead to modest savings in terms of reduced prescribing . Future research should focus on whether such a prescribing effect would make this type of intervention cost effective Background The concept of pharmaceutical care is operationalized through pharmaceutical professional services , which are patient-oriented to optimize their pharmacotherapy and to improve clinical outcomes . Objective The objective of this study was to estimate the incremental cost-effectiveness ratio ( ICER ) of a medication review with follow-up ( MRF ) service for older adults with polypharmacy in Spanish community pharmacies against the alternative of having their medication dispensed normally . Methods The study was design ed as a cluster r and omized controlled trial , and was carried out over a time horizon of 6 months . The target population was older adults with polypharmacy , defined as individuals taking five or more medicines per day . The study was conducted in 178 community pharmacies in Spain . Cost-utility analysis adopted a health service perspective . Costs were in euros at 2014 prices and the effectiveness of the intervention was estimated as quality -adjusted life-years ( QALYs ) . In order to analyze the uncertainty of ICER results , we performed a non-parametric bootstrapping with 5000 replications . Results A total of 1403 older adults , aged between 65 and 94 years , were enrolled in the study : 688 in the intervention group ( IG ) and 715 in the control group ( CG ) . By the end of the follow-up , both groups had reduced the mean number of prescribed medications they took , although this reduction was greater in the IG ( 0.28 ± 1.25 drugs ; p < 0.001 ) than in the CG ( 0.07 ± 0.95 drugs ; p = 0.063 ) . Older adults in the IG saw their quality of life improved by 0.0528 ± 0.20 ( p < 0.001 ) . In contrast , the CG experienced a slight reduction in their quality of life : 0.0022 ± 0.24 ( p = 0.815 ) . The mean total cost was € 977.57 ± 1455.88 for the IG and € 1173.44 ± 3671.65 for the CG . In order to estimate the ICER , we used the costs adjusted for baseline medications and QALYs adjusted for baseline utility score , result ing in a mean incremental total cost of −€250.51 ± 148.61 ( 95 % CI −541.79 to 40.76 ) and a mean incremental QALY of 0.0156 ± 0.004 ( 95 % CI 0.008–0.023 ) . Regarding the results from the cost-utility analysis , the MRF service emerged as the dominant strategy . Conclusion The MRF service is an effective intervention for optimizing prescribed medication and improving quality of life in older adults with polypharmacy in community pharmacies . The results from the cost-utility analysis suggest that the MRF service is cost effective BACKGROUND Older people in nursing and residential homes often have complex disabilities and behavioural disturbances . Recent publicity has highlighted the dangers of medication in this group , and controls over prescribing have been suggested . AIMS To investigate the effect of a review of medication by a pharmacist . METHOD An 8-month prospect i ve trial of an active medication review by a pharmacist was carried out on 330 residents in nursing homes in Manchester . RESULTS The intervention group experienced greater deterioration in cognitive function and behavioural disturbance than the control group , but the changes in depression and quality of life were similar for both groups . The number of drugs prescribed fell in the intervention group , but not in the control group , with a corresponding saving in drug costs . The number of deaths was significantly smaller in the intervention homes during the intervention period ( 4 v. 14 ) but not overall during the study period as a whole ( 26 v. 28 ) . CONCLUSION This clinical intervention reduced the number of medicines prescribed to elderly people in nursing homes , with minimal impact on their morbidity and mortality BACKGROUND drug intake is associated with the risk of drug-related problems ( DRPs ) , e.g. the intake of PIM . OBJECTIVE the proportion of potentially inappropriate medication ( PIM ) taken by elderly people was analysed . DESIGN community-based , prospect i ve cohort study . SETTING ambulatory health-care sector in a German rural area . SUBJECTS seven hundred and forty-four patients with age > 65 years and regular intake of drugs . METHODS comprehensive home medication review ( HMR ) provided by specially qualified assistants of GP practice s using electronic case reporting forms ( eCRFs ) , and GP 's diagnoses were extracted from patients ' health records . Up date d Beers ' list of Fick et al. was used to detect PIM for patients > 65 years and drug-condition interaction . RESULTS a total of 18 % ( n= 134 ) of the patients received 163 inappropriate drugs . Out of these drugs , most prevalent PIM were benzodiazepine derivates ( n= 45 ) . Out of all drugs , 25 drug-condition interactions were identified . The intake of PIM was slightly associated with self-reported falls (: 0.1074 ; P= 0.0244 ) . Multivariate logistic regression showed significant results for the number of taken substances ( OR = 1.176 ; 95 % CI 1.121 - 1.234 , P < 0.001 ) . CONCLUSIONS a high proportion of patients taking PIM in a community-based setting were investigated . Statistical associations with self-reported falls were found . Confounding may influence data . Further research to investigate findings is needed OBJECTIVE To evaluate the effect of a medication therapy management ( MTM ) intervention on adverse drug events ( ADEs ) , health care visits , and drug-related problems ( DRPs ) . DESIGN R and omized , controlled , clinical trial . SETTING Academic medical center community pharmacies and family medicine clinics at three U.S. sites between December 2007 and January 2010 PATIENTS Individuals aged 65 years or older with three or more chronic illnesses , six or more prescription medications , and at risk for a DRP . INTERVENTION At 0 and 3 months , pharmacists conducted comprehensive medication review s and screened for and resolved DRPs through patient education and recommendations to physicians . MAIN OUTCOME MEASURES Frequency of ADEs reported by patients and confirmed by clinical algorithm , health care visits at 3 and 6 months , and number of DRPs , pharmacist recommendations , and medication discrepancies . RESULTS 637 participants enrolled . No differences were observed in potential ADEs or health care visits among the usual care and MTM groups . DRPs declined in both MTM intervention groups over time . Physicians responded to 54.6 % of pharmacist recommendations . Enhanced MTM patients had fewer medication list discrepancies than basic MTM patients ( 33.8 % vs. 47.1 % , P < 0.001 ) . CONCLUSION This specific design of MTM was associated with reduced DRPs but did not reduce potential ADEs or health care visits OBJECTIVES To test the efficacy of a medication use improvement program developed specifically for home health agencies . The program addressed four medication problems identified by an expert panel : unnecessary therapeutic duplication , cardiovascular medication problems , use of psychotropic drugs in patients with possible adverse psychomotor or adrenergic effects , and use of nonsteroidal antiinflammatory drugs ( NSAIDs ) in patients at high risk of peptic ulcer complications . It used a structured collaboration between a specially trained clinical pharmacist and the patients ' home-care nurses to improve medication use . DESIGN Parallel-group , r and omized controlled trial . SETTING Two of the largest home health agencies in the United States . PARTICIPANTS Study subjects were consenting Medicare patients aged 65 and older admitted to participating agency offices from October 1996 through September 1998 , with a projected home healthcare duration of at least 4 weeks and at least one study medication problem . INTERVENTION Qualifying patients were r and omized to usual care or usual care with the medication improvement program . MEASUREMENTS Medication use was measured during an in-home interview , with container inspection at baseline and at follow-up ( between 6 and 12 weeks ) by interviewers unaware of treatment assignment . The trial endpoint was the proportion of patients with medication use improvement according to predefined criteria at follow-up . RESULTS There were 259 r and omized patients with completed follow-up interviews : 130 in the intervention group and 129 with usual care . Medication use improved for 50 % of intervention patients and 38 % of control patients , an attributable improvement of 12 patients per 100 ( 95 % confidence interval ( CI ) = 0.0 - 24.0 , P = .051 ) . The intervention effect was greatest for therapeutic duplication , with improvement for 71 % of intervention and 24 % of control patients , an attributable improvement of 47 patients per 100 ( 95 % CI = 20 - 74 , P = .003 ) . Use of cardiovascular medications also improved more frequently in intervention patients : 55 % vs 18 % , attributable improvement 37 patients per 100 ( 95 % CI = 9 - 66 , P = .017 ) . There were no significant improvements for the psychotropic medication or NSAID problems . There was no evidence of adverse intervention effects : new medication problems , more agency nurse visits , or increased duration of home health care . CONCLUSIONS A program congruent with existing personnel and practice s of home health agencies improved medication use in a vulnerable population and was particularly effective in reducing therapeutic duplication BACKGROUND efficient strategies are needed to provide specialist advice in nursing homes to ensure quality medical care . We describe a case conference intervention involving a multidisciplinary team of health professionals . OBJECTIVES to evaluate the impact of multidisciplinary case conferences on the appropriateness of medications and on patient behaviours in high-level residential aged care facilities . DESIGN cluster-r and omised controlled trial . SETTING ten high-level aged care facilities . PARTICIPANTS 154 residents with medication problems and /or challenging behaviours were selected for case conference by residential care staff . INTERVENTION two multidisciplinary case conferences involving the resident 's general practitioner , a geriatrician , a pharmacist and residential care staff were held at the nursing home for each resident . MEASUREMENTS outcomes were assessed at baseline and 3 months . The primary outcome was the Medication Appropriateness Index ( MAI ) . The behaviour of each resident was assessed via the Nursing Home Behaviour Problem Scale . RESULTS 45 residents died before follow-up . Medication appropriateness improved in the intervention group [ MAI mean change 4.1 , 95 % confidence interval ( CI ) 2.1 - 6.1 ] compared with the control group ( MAI mean change 0.4 , 95 % CI -0.4 - 1.2 ; P < 0.001 ) . There was a significant reduction in the MAI for benzodiazepines ( mean change control -0.38 , 95 % CI -1.02 - 0.27 versus intervention 0.73 , 95 % CI 0.16 - 1.30 ; P = 0.017 ) . Resident behaviours were unchanged after the intervention and the improved medication appropriateness did not extend to other residents in the facility . CONCLUSION multidisciplinary case conferences in nursing homes can improve care . Outreach specialist services can be delivered without direct patient contact and achieve improvements in prescribing Background : The drug burden index ( DBI ) is an evidence -based tool that utilizes pharmacologic principles to calculate an individual 's total exposure to anticholinergic and sedative medications . Higher DBI has been associated with functional impairment in observational studies of older people . Objective : To assess the impact of providing information about DBI to general practitioners ( GPs ) on prescribing for older people . Methods : This was a cluster r and omized controlled trial with 3 months of follow-up . Participants were volunteers aged ≥70 years , living in self-care retirement villages in Sydney , Australia . The study intervention involved a letter and phone call to GPs , using DBI to prompt them to consider cessation or dose reduction of anticholinergic and sedative medications . The primary study outcome was to assess the impact of information about DBI on prescribing practice s of the GPs . Results : A total of 115 participants were enrolled , 57 in the intervention group ( from 6 sites ) and 58 in the control group ( from 6 sites ) . At baseline , 19 of 57 participants in the intervention group and 31 of 58 participants in the control group had a DBI > 0 ( p < 0.05 ) . At follow-up , a DBI change was observed in 16 participants . DBI decreased in 12 participants , 6 ( 32 % ) in the intervention group , and 6 ( 19 % ) in the control group . GPs identified the following barriers to reducing anticholinergic and sedative drugs : uncomfortable altering prescriptions initiated by specialists ; unable to influence patients ' attitudes ; unaware of patients ' medications and strong clinical indication . Conclusions : The intervention targeting GPs ' prescribing practice s was less effective than anticipated in reducing anticholinergic and sedative drug exposure , and barriers were identified . Future studies should explore multidisciplinary interventions , engaging patients , specialists , GPs , and pharmacists OBJECTIVES There are conflicting results in studies of pharmacists undertaking medication review s for older people . With increasing promotion and funding for ' medication review s ' there is a need for them to be st and ardised , and to determine their effectiveness and the feasibility of providing them from a community pharmacy . The objective was to determine whether involvement of community pharmacists undertaking clinical medication review s , working with general practitioners , improved medicine-related therapeutic outcomes for patients . METHODS A r and omised controlled trial was carried out in people 65 years and older on five or more prescribed medicines . Community pharmacists undertook a clinical medication review ( Comprehensive Pharmaceutical Care ) and met with the patient 's general practitioner to discuss recommendations about possible medicine changes . The patients were followed-up 3-monthly . The control group received usual care . The main outcome measures were Quality of Life ( SF-36 ) and Medication Appropriateness Index . KEY FINDINGS A total of 498 patients were enrolled in the study . The quality -of-life domains of emotional role and social functioning were significantly reduced in the intervention group compared to the control group . The Medication Appropriateness Index was significantly improved in the intervention group . Only 39 % of the 44 pharmacists who agreed to participate in the study provided adequate data , which was a limitation of the study and indicated potential barriers to the generalisability of the study . CONCLUSION Clinical medication review s in collaboration with general practitioners can have a positive effect on the Medication Appropriateness Index . However , pharmacist withdrawal from the study suggests that community pharmacy may not be an appropriate environment from which to exp and clinical medication review s in primary care Outcome reporting in bariatric surgery needs a core outcome set ( COS ) , an agreed minimum set of outcomes reported in all studies of a particular condition . The aim of this study was to summarize outcome reporting in bariatric surgery to inform the development of a COS . Outcomes reported in r and omized controlled trials ( RCTs ) and large non-r and omized studies identified by a systematic review were listed verbatim and categorized into domains , scrutinizing the frequency of outcome reporting and uniformity of definitions . Ninety studies ( 39 RCTs ) identified 1,088 separate outcomes , grouped into nine domains with most ( n = 920 , 85 % ) reported only once . The largest outcome domain was ' surgical complications ' , and overall , 42 % of outcomes corresponded to a theme of ' adverse events ' . Only a quarter of outcomes were defined , and where provided definitions , which were often contradictory . Percentage of excess weight loss was the main study outcome in 49 studies , but nearly 40 % of weight loss outcomes were heterogeneous , thus not comparable . Outcomes of diverse bariatric operations focus largely on adverse events . Reporting is inconsistent and ill-defined , limiting interpretation and comparison of published studies . Thus , we propose and are developing a COS for the surgical treatment of severe and complex obesity Background : There are concerns that automated drug dispensing may increase inappropriate drug use . Automated dispensing could lead to perpetual repeating of drug therapies without the necessary re-evaluation . Objectives : The aim of this study was to examine the effect of a pharmacist-led medication review on drug-related problems ( DRPs ) in older patients receiving their drugs via automated dispensing . Methods : This was a pragmatic r and omized controlled study conducted in primary care . Patients were recruited from six Dutch community pharmacies . They were eligible if they lived at home , were aged ≥65 years , and used five or more different drugs , of which at least one had to be dispensed via an automated system . Patients were r and omly allocated to receive a medication review at the start of the study ( intervention group ) or after 6 months ( waiting-list group ) . Each patient was independently review ed by two pharmacist review ers . The results of these medication review s were sent to the community pharmacist to be discussed with the patient ’s general practitioner ( GP ) . The primary outcome measure was the number of DRPs leading to a recommendation for drug change . Secondary outcomes were the total number of drug changes and the number of drug changes related to a recommendation . In order to analyse drug changes , medication records were collected 6 months after the medication review or index date in the waiting-list group . Potential DRPs were classified using the DOCUMENT classification . Results : There were no baseline differences between the 63 patients in the intervention group and the 55 patients in the waiting-list group with respect to age , sex , number of drugs per patient and type of drug prescribed . The mean number of DRPs per patient at baseline in the intervention group and waiting list combined was 8.5 , with no difference between the groups . At baseline , the mean number of DRPs leading to a recommendation for drug change was 4.5 per patient and did not differ between the two groups . After 6 months , the number of DRPs leading to a recommendation for drug change decreased by 29 % in the intervention group versus 5 % in the waiting-list group ( p < 0.01 ) . Recommendations for cessation of a drug were more frequently accepted than recommendations to add a new drug ( 82 % vs 44 % , p = 0.01 ) . Conclusions : This study shows that patients using automated drug dispensing have a high number of DRPs . Medication review decreases the number of DRPs among these patients . We recommend that all patients with automatic drug dispensing should have a thorough medication review by pharmacists and prescribers Background Hospital admissions may provide an opportunity to discontinue potentially inappropriate medications ( PIMs ) in older patients . Little is known about the effect of using the Screening Tool of Older People ’s potentially inappropriate Prescriptions ( STOPP ) in this context . This study aim ed to test the hypothesis that specific STOPP recommendations from an inpatient geriatric consultation team ( IGCT ) to the hospital physician leads to reductions in PIMs for patients at discharge . Methods This was a r and omised controlled study in 146 frail in patients ( in 2011 ) . The intervention consisted of STOPP recommendations made by the IGCT to ward physicians to discontinue PIMs , in addition to the st and ard geriatric advice . Results Intervention ( n = 74 ) and control ( n = 72 ) groups were similar in terms of patient characteristics ( median age 85 years ; median number of daily drugs , seven ) and PIM distribution ( 68 and 57 PIMs in 53 and 51 % of patients , respectively ) . At discharge , the reduction in PIMs was twice as high for the intervention group as for the control group ( 39.7 and 19.3 % , respectively ; p = 0.013 ) . The proportion of patients who still had one or more PIM at discharge did not differ between groups . In the 50 patients followed-up a year later , the majority of PIMs that had been stopped during hospitalisation had not been restarted after discharge ( 17/28 ; 61 % ) . The clinical relevance of PIMs identified at baseline in those patients was considered major ( 29 % ) , moderate ( 37 % ) , minor ( 5 % ) , deleterious ( 8 % ) , or not assessed ( 11 % ) . Discontinuation rate was not associated with clinical importance . ConclusionS pecific STOPP recommendations provided to hospital physicians doubled the reduction of PIMs at discharge in frail older in patients . To further improve the appropriateness of prescribing in older patients , clinicians should focus on the STOPP criteria that are of major clinical importance , and general practitioners should be actively involved |
1,310 | 32,082,627 | No cancer was detected if the PSA level decreased to < 4 ng/mL. Conclusion : Antibiotic therapy is clinical ly beneficial in patients with high PSA levels .
PSA reduction or normalisation after medical therapy , either antibiotic and /or NSAID , for ≥ 2 weeks can avoid unnecessary PBx . | ABSTRACT Objective : To address the question of whether antibiotic therapy can obviate the need for prostate biopsy ( PBx ) in patients presenting with high prostate-specific antigen ( PSA ) levels . | Purpose We aim ed to reduce unnecessary prostatic biopsy in patients with high prostate-specific antigen ( PSA ) by consideration of prostatic inflammation . Material s and Methods The investigation was conducted prospect ively in 413 patients with a PSA level of 4 to 10 ng/ml from January 2004 to December 2009 . All patients underwent the expressed prostatic secretion ( EPS ) or voided bladder urine 3 ( VB3 ) test to be classified into two groups : positive group and negative group . Patients with a positive result on the EPS or VB3 test were treated with antibiotics for 2 months , and in cases in which the PSA level remained high , we performed prostate biopsy . In patients with a negative result on the VB3 test , we performed prostate biopsy directly . Results Of the 413 study patients , 215 ( 52 % ) patients had positive findings on the EPS or VB3 test . After 8 weeks of antibiotics therapy , 53 of the 215 men avoided prostate biopsy because their PSA level was normalized . The other patients ( 162 of 215 ) still had elevated PSA levels of more than 4 ng/ml , including 7 patients in whom the biopsy revealed cancer . Patients with negative findings ( 198 of 413 ) underwent prostate biopsy . Of the 198 patients , 41 were diagnosed with prostate cancer . The total prostate cancer detection rate was 11.6 % in our subjects , where as it was 20.7 % in the patients with negative findings on the EPS or VB3 and 3.3 % in the patients with positive findings , respectively . Conclusions In cases in which the PSA level is increasing , if we first exclude prostatitis and carry out a serial diagnostic procedure , it may help to reduce unnecessary prostatic biopsy Purpose We investigated the effect of antibiotics on PSA in asymptomatic patients with mild PSA elevation . Material s and Methods We prospect ively evaluated , in a non-r and omized design , 106 asymptomatic patients with PSA of 4 - 10ng/mL , with a negative digital rectal examination and with no urinary tract infection evidence for 2 years . Patients were divided into two groups : those treated with antibiotics for 3 weeks ( G1 ) and those who were not treated ( G2 ) . PSA was taken six weeks after and prostate biopsy was performed in all patients . Results PCa was diagnosed in 25 of 106 patients ( 23.6 % ) : 16 ( 25.0 % ) in G1 and 9 ( 21.4 % ) in G2 ( p>0.05 ) . PSA normalization was experienced in 24.5 % . In G1 , PSA returned to < 4ng/mL in 15 ( 23.4 % ) patients compared to 11 ( 26 % ) patients in G2 . In the patients with a positive biopsy , no significant variation was noted in PSA , fPSA , % fPSA and DPSA after antibiotic treatment . A significantly lower cancer detection rate was noted with decreased PSA , fPSA , and DPSA after antibiotic use . A PSA reduction rate of ≥10 % occurred in 58.5 % , and this was similar in both G1 and G2 groups . The sensibility , specificity and accuracy of PSA reduction of ≥10 % were 31 % , 23 % and 25 % , respectively . Conclusion Empirical antibiotic therapy in asymptomatic male patients is not related to PSA reduction . The greater than 10 % PSA reduction after antibiotic in this population can not postpone prostate biopsy PURPOSE This controlled prospect i ve study aims to investigate the possible effects of antibiotic treatment on prostate-specific antigen ( PSA ) and its derivatives , and consequently on the transrectal biopsy rates , in the diagnosis of prostate cancer . PATIENTS AND METHODS One hundred and forty patients aged 45 to 70 years old , with a PSA level between 2.5 and 10 ng/mL and normal digital rectal examinations ( DRE ) , were included in this study between June 2009 and November 2010 . The patients were r and omly assigned into two groups . The first group received oral levofloxacin 500 mg 1 * 1 for 21 days ; the second , the control group , was given no treatment . Initially , total PSA , free PSA , a DRE , urinary ultrasonography ( including prostate volume , postvoiding residual urine ) , uroflowmetry , International Prostate Symptom Score , National Institutes of Health Chronic Prostatitis Symptom Index , and International Index of Erectile Function tests were performed . All of these were repeated at the end of 3 weeks of antibiotic treatment . An additional PSA measurement was also performed at day 10 of the treatment . All patients underwent transrectal ultrasonography ( TRUS ) guided prostate biopsy at day 21 , just the day after the final ( third ) PSA sampling . RESULTS The mean age of the patients was 59.6 years . Overall , in 23 patients , prostate cancer was detected , including those found in the rebiopsies . Statistically , there were significant changes in values of PSA and its derivatives in the treatment group ( from 5.31 to 4.69 and 4.58 ng/mL , consecutively ) . Focusing on prostate cancer patients in both the treatment and control groups , however , we did not detect any significant change in the same parameters . CONCLUSION Antibiotic treatment given to the patients with a PSA level between 2.5 and 10 ng/mL can be beneficial , before a decision for TRUS guided prostate biopsy , just in a limited subgroup , by reducing the PSA levels below the threshold value . Considering the large population of patients in the gray zone , however , it still does not provide clear solid evidence for avoiding unnecessary prostate biopsies INTRODUCTION We investigated if antibiotherapy has any role on total PSA ( tPSA ) , free PSA ( fPSA ) and fPSA/tPSA ratio in patients with tPSA higher than 2.5ng/ml . We also analyzed if it has any relation with prostate cancer diagnosis rate . MATERIAL AND METHODS A total 108 patients older than 50 years of age with lower urinary system sypmtoms and tPSA > 2.5ng/ml were included in this study . Antibiotherapy was given to all the cases for three weeks . After that , transrectal ultrasound-guided prostate biopsies were taken from all the patients . Before and after antibiotherapy , " The International Prostate Symptom Score " ( IPSS ) and " National Institutes of Health Chronic Prostatitis Symptom Index " ( NIH-CPSI ) questinories are performed and serum tPSA , fPSA and fPSA/tPSA values were obtained . RESULTS TPSA , fPSA and fPSA/tPSA ratio alterations prior to and after antibiotherapy did not show any statistically significant difference ( p>0.05 ) . When prostate adenocarcinoma was excluded , an statistically significant decrease was found in IPSS and NIH-CPSI scores for all cases . CONCLUSIONS Antibiotherapy given to patients with PSA levels higher than threshold value has not led to significant change in prostate needle biopsy decision . Prostate biopsy should be considered without trying antibiotherapy in patients with high PSA values if a suspicion of prostatitis does not exist PURPOSE We compared baseline and post-therapy prostate specific antigen ( PSA ) in patients with chronic bacterial prostatitis who were treated with levofloxacin or ciprofloxacin . MATERIAL S AND METHODS Subset analysis was done using a r and omized , multicenter , double-blind , active control trial of 500 mg levofloxacin daily for 28 days vs 500 mg ciprofloxacin twice daily in 28 days in men with chronic bacterial prostatitis . RESULTS Of the 377 men in the intent to treat population , including 197 treated with levofloxacin and 180 treated with ciprofloxacin , 35 on levofloxacin and 37 on ciprofloxacin with baseline PSA greater than 4 ng/ml were included in this analysis . Excluded from analysis were 2 levofloxacin treated patients with extremely high PSA at baseline ( 62 and 103 ng/ml , respectively ) . Mean baseline PSA + /- SD in the patients analyzed was 8.33 + /- 4.46 ng/ml , which decreased to 5.36 + /- 3.82 ng/ml after therapy . There was no significant difference in the mean change in PSA between the levofloxacin and ciprofloxacin groups . Approximately 42 % of patients with increased baseline PSA had a post-therapy PSA of 4 ng/ml or less . Of patients who were microbiologically evaluable and had normalized PSA after therapy levofloxacin eradicated the pathogen in 90.9 % ( 10 of 11 ) . However , of patients in whom post-therapy PSA remained increased the microbiological eradication rate was 69.2 % ( 9 of 13 ) . Similarly 93.3 % of the ciprofloxacin group ( 14 of 15 patients ) with normalized post-therapy PSA experienced microbiological eradication compared with 61.5 % ( 8 of 13 ) with continued increased PSA after therapy . CONCLUSIONS Approximately 20 % of patients diagnosed with chronic bacterial prostatitis had increased PSA . A significant decrease in PSA was observed in these patients after treatment with levofloxacin or ciprofloxacin . An association was observed between bacterial persistence and the likelihood that PSA would return to normal PURPOSE We attempted to identify morphological parameters of benign prostatic hyperplastic inflammation that correlate with pre-biopsy prostate specific antigen ( PSA ) concentrations . MATERIAL S AND METHODS Patients undergoing prostate biopsy at our department were prospect ively studied between January 1995 and January 1996 . preoperative blood and 24-hour urine sample s were measured for PSA . Biopsy sample s harboring exclusively benign prostatic tissue were grade d on a 4-point scale for inflammation ( 0-no inflammatory cells , 1-scattered inflammatory cell infiltrate , 2-nonconfluent lymphoid nodules and 3-large inflammatory areas with confluence of infiltrate ) and aggressiveness ( 0-no contact between inflammatory cells and gl and ular epithelium ; 1-contact between inflammatory cell infiltrate and gl and ular epithelium ; 2-clear but limited , that is less than 25 % of the examined material , gl and ular epithelium disruption , and 3-gl and ular epithelium disruption on more than 25 % of the examined material ) . RESULTS A total of 66 patients with exclusively benign prostatic tissue on prostate biopsies was analyzed . Difference between inflammation grade d groups was not significant when considering serum or urinary PSA . There was a significant correlation between aggressiveness grading and serum PSA ( rho = 0.51 , p < 0.0001 ) , whereas aggressiveness grading and urinary PSA did not correlate ( rho = -0.06 , p = 0.6 ) . CONCLUSIONS Prostatic sub clinical inflammation is not associated with high urinary PSA . Unless associated with gl and ular epithelial disruption , density of prostatic interstitial inflammatory cell infiltrate is not significantly correlated with serum PSA concentration . We believe that this issue should be considered when interpreting a prostate biopsy Purpose We evaluated men with documented chronic prostatitis and elevated serum prostate-specific antigen ( PSA ) to determine whether treatment with antibiotics and anti-inflammatory drugs can lower serum PSA and the cancer detection rate in patients with post-treatment PSA < 4 ng/ml . Material s and Methods Eighty-six men who presented with serum PSA greater than 4 ng/ml and who were subsequently diagnosed with chronic prostatitis with greater than 10 white blood cells per high power field in expressed prostatic excretions were included in this prospect i ve study . Patients meeting these criteria underwent treatment with a 4-week course of antibiotics and nonsteroidal anti-inflammatory agents . Follow-up PSA and transrectal ultrasonography-guided prostate biopsy were performed within 2 months of treatment for all patients . Results Mean patient age was 56.2 years ( range , 37 - 72 years ) . Mean PSA ( ng/ml ) decreased by 33.8 % , from 8.12 ( range , 4.02 - 24.8 ) to 5.37 ( range , 1.35 - 12.94 ) , after treatment ( p=0.001 ) . Pathological studies revealed prostate cancer in 18 cases ( 20.9 % ) , chronic inflammation in 64 ( 74.4 % ) , and benign prostatic hypertrophy in 4 ( 4.7 % ) . The prostate cancer detection rate according to the follow-up PSA level , below 2.5 , from 2.5 to 4.0 , and above 4.0 , was 13.3 % ( 2/15 ) , 13.6 % ( 3/22 ) , and 26.5 % ( 13/49 ) , respectively . Conclusions When chronic prostatitis with elevated PSA is identified , antibiotic and anti-inflammatory treatment can lower these PSA levels . However , the possibility of prostate cancer remains in patients whose PSA level decreases to less than 4 ng/ml , even in those with a PSA level less than 2.5 ng/ml Objective Evaluate male patients with diagnosed chronic prostatitis , elevated serum prostate-specific antigen ( PSA ) to find out whether medical treatment with antibiotics and anti-inflammatory drugs can lower serum PSA , and consequently decrease the prostate cancer detection rate in patients with post-treatment PSA<4 ng/mL. Material s and methods This prospect i ve study evaluated 142 male patients aged 40 - 73 years whose presented with elevated serum PSA>4 ng/mL and were consequently diagnosed with chronic prostatitis as expressed prostatic excretions examination revealed more than 10 white blood cells per high power field . The Patients underwent treatment with antibiotics and nonsteroidal anti-inflammatory agents for 6-weeks . Subsequently , all patients are Followed-up by serum PSA and performed transrectal ultrasonography-guided prostate biopsy within 2 months of treatment . Results Mean patient age was ( 54.4±13.5 ) years . The mean PSA pretreatment was ( 8.11±3.7 ) ng/mL and after treatment , the mean PSA denoted a significant decrease to ( 4.7±3.5 ) ng/mL ( P=0.002 ) . The percent of changes in mean PSA was 41.9 % . Prostatic biopsy after treatment showed that , cancer prostate in 31 patients ( 21.8 % ) , chronic prostatitis in 71 patients ( 50.7 % ) , chronic prostatitis plus benign prostatic hyperplasia ( BPH ) in 31 ( 21.8 % ) and BPH in 9 patients ( 6.3 % ) With regard to PSA values , cancer prostate patients were 3/25 ( 12 % ) if PSA<2.5 ng/mL , 6/47 ( 12.7 % ) if 4.0>PSA≥2.5 and 21/70 ( 30 % ) if PSA≥4.0 . The numbers of cancer prostate detected patients were 30 ( 21.1 % ) . Conclusions Chronic prostatitis is one of the causes that elevate serum PSA levels . Treatment of chronic prostatitis with elevated PSA by antibiotics and anti-inflammatory agents can decrease the elevated PSA to the normal levels . Nevertheless , the opportunities of potential prostate cancer still exist in patients with a decreased PSA level even also if PSA<2.5 To evaluate exclusion of prostate cancer ( PCa ) by using empiric antibiotic treatment for patients with total prostate specific antigen ( PSA ) between 4 - 10 ng/ml . A hundred asymptomatic men with a PSA between 4 - 10 ng/ml and normal digital rectal examination ( DRE ) were enrolled in this r and omized prospect i ve study . The treatment group ( n=50 ) was given 400 mg of ofloxacin daily for 4 weeks , whereas the control group ( n=50 ) was followed without any treatment . At the end of the four weeks , repeat PSA were measured and all patients underwent transrectal ultrasound ( TRUS ) guided biopsy , regardless of the repeat PSA levels . Totally 22 patients ( 22 % ) had prostate cancer ( 9 in treatment group and 13 in control group ) . A significant PSA decrease was observed in the treatment group at repeat PSA measurements ( p=0.001 ) . The PSA drop was also significantly more in patients without PCa than with PCa ( p=0.028 ) . In patients whose repeat PSA after antibiotic treatment decreased below 4 ng/ml , 2 times as many patients ( 16.6 % ) had PCa in the control group when compared with the treatment group ( 8.3 % ) . On the other h and , in patients whose repeat PSA remained above 4 ng/ml , PCa was detected in 27.3 % of the patients in the control group and 21 % in the treatment group . Empirical antibiotic treatment in asymptomatic patients with a PSA level 4 - 10 ng/ml and a normal DRE may be used to select prostate biopsy c and i date s. Studies with higher number of patients may result in more powerful associations with narrower confidence intervals for increased confidence Objective : The primary aim was to evaluate the change in the total and free PSA levels after antibiotic and non-steroid anti-inflammatory treatment . The secondary aim was to compare this change among the histological subgroups to assess whether it was discriminating . Methods : 97 consecutive patients with PSA > 4 ng/dl and scheduled for prostate biopsy were included in this prospect i ve study . 65 patients ( group 1 ) were then put on medical treatment of ciprofloxacin 500 mg bid and diclofenac sodium 75 mg during the routine waiting period before the 2- to 3-week procedure . R and omly selected ( every third case ) 32 patients ( group 2 ) did not receive this treatment . Free and total PSA tests were repeated before the procedure . The change in the PSA values was compared between the groups and among the histological subgroups in group 1 . Results : While in group 1 the decrease in PSA was significant ( p = 0.000 ) , this was not the case in group 2 . The difference in free PSA values was unremarkable for both groups . In histologically determined cancer cases of group 1 , the difference between pre- and post-procedure PSA level was not of note , while in BPH and prostatitis cases it was significant . Conclusion : In cases with increased PSA , medical treatment for a likely sub clinical prostatitis result ed in a decrease of PSA , which was significant only in benign conditions OBJECTIVE To explore the efficacy of compound ciprofloxacin suppository ( CCS ) combined with Ningbitai ( NBT ) and Yunnan Baiyao ( YB ) capsules in the treatment of histological prostatitis with elevated levels of PSA . METHODS This study included 150 cases of type IIIA histological prostatitis , with PSA levels ranging from 4 to 50 microg/L. After 1 month 's treatment with oral Levofloxacin tablets at 0.5 g qd , the PSA levels remained high in 86 patients . Prostate cancer was excluded by transrectal ultrasound-guided prostatic biopsy , and histological prostatitis was confirmed in 65 patients , who were assigned to an experimental group ( n=45 ) and a control group ( n=20 ) to receive CCS combined with NBT and YB capsules and CCS with NBT only , respectively , both for 4 weeks . We determined the PSA levels , obtained NIH-CPSI scores before and after medication , and compared them between the two groups . RESULTS The two groups were well balanced in demographics and baseline characteristics . After treatment , both showed significant differences in the PSA level , PSA density ( PSAD ) and CPSI scores from the baseline ( P<0.05 ) , and there were also statistically significant differences between the two groups in the changes of the PSA level and CPSI scores after medication ( P = 0.029 and 0.001 ) . CONCLUSION Compound ciprofloxacin suppository combined with Ningbitai and Yunnan Baiyao capsules can significantly decrease the level of serum PSA and relieve related symptoms in III A histological prostatitis with PSA elevation , and Yunnan Baiyao capsules can significantly enhance the therapeutic effect Microscopic foci of prostatitis may induce prostate-specific antigen ( PSA ) increase . PSA reduction after antibiotics might identify those patients in whom biopsy can be avoided . Ninety-nine patients received ciprofloxacin for 3 weeks , of whom 59 showed PSA reduction . Histology detected small foci of prostatitis in 65 % of cases . Carcinoma was found in 40 and 20.3 % of patients with unchanged or decreased PSA , respectively ( P=0.03 ) . No cancer was detected if PSA decreased below 4 ng/ml or more than 70 % . Biopsy can be postponed , with a low risk of missing a cancer , if PSA decreases more than 70 % or below 4 ng/ml PURPOSE Prostate inflammation can lead to an increase in serum prostate specific antigen concentration and confound the use of prostate specific antigen kinetics . Repeat prostate specific antigen measurements after a period of observation or a course of empirical antibiotics are controversial in terms of the optimal approach to reduce the confounding impact on prostate cancer screening . This issue was analyzed in patients with a diagnosis of type IV or asymptomatic prostatitis ( National Institutes of Health classification ) and high prostate specific antigen . MATERIAL S AND METHODS We studied 200 men between 50 and 75 years old with a high prostate specific antigen ( between 2.5 and 10 ng/dl ) . Of these patients 98 ( 49 % ) had a diagnosis of type IV prostatitis . In a prospect i ve , double-blind trial they were r and omized to receive placebo ( 49 patients , group 1 ) or 500 mg ciprofloxacin ( 49 patients , group 2 ) twice a day for 4 weeks . Prostate specific antigen was determined after treatment and all patients underwent transrectal ultrasound guided biopsy of the prostate . RESULTS In group 1 , 29 ( 59.18 % ) patients presented with a decrease in prostate specific antigen and 9 ( 31 % ) had cancer on biopsy , while in group 2 there were 26 ( 53.06 % ) patients with a decrease in prostate specific antigen and 7 ( 26.9 % ) with prostate cancer . There was no statistical difference in either group in relation to prostate specific antigen decrease after treatment or the presence of tumor . CONCLUSIONS A considerable number of patients ( 49 % ) were diagnosed with type IV prostatitis and high prostate specific antigen in agreement with the current literature . Of the patients 26.9 % to 31 % presented with a decrease in prostate specific antigen after the use of antibiotic or placebo and harbor cancer as demonstrated on prostate biopsy . Prostate specific antigen decreases do not indicate the absence of prostate cancer |
1,311 | 31,981,539 | INTERPRETATION Psychological interventions treat anxiety effectively in women with current or recent intimate partner violence exposure in LMICs when delivered by appropriately trained and supervised health-care staff , even when not tailored for this population or targeting intimate partner violence directly . | BACKGROUND Evidence on the effectiveness of psychological interventions for women with common mental disorders ( CMDs ) who also experience intimate partner violence is scarce .
We aim ed to test our hypothesis that exposure to intimate partner violence would reduce intervention effectiveness for CMDs in low-income and middle-income countries ( LMICs ) . | Summary Background Although structured psychological treatments are recommended as first-line interventions for depression , only a small fraction of people globally receive these treatments because of poor access in routine primary care . We assessed the effectiveness and cost-effectiveness of a brief psychological treatment ( Healthy Activity Program [ HAP ] ) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care setting s. Methods In this r and omised controlled trial , we recruited participants aged 18–65 years scoring more than 14 on the Patient Health Question naire 9 ( PHQ-9 ) indicating moderately severe to severe depression from ten primary health centres in Goa , India . Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible . Participants were r and omly allocated ( 1:1 ) to enhanced usual care ( EUC ) alone or EUC combined with HAP in r and omly sized blocks ( block size four to six [ two to four for men ] ) , stratified by primary health centre and sex , and allocation was concealed with use of sequential numbered opaque envelopes . Physicians providing EUC were masked . Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression ( PHQ-9 score of < 10 ) at 3 months in the intention-to-treat population , assessed by masked field research ers . Secondary outcomes were disability , days unable to work , behavioural activation , suicidal thoughts or attempts , intimate partner violence , and re source use and costs of illness . We assessed serious adverse events in the per- protocol population . This trial is registered with the IS RCT N registry , number IS RCT N95149997 . Findings Between Oct 28 , 2013 , and July 29 , 2015 , we enrolled and r and omly allocated 495 participants ( 247 [ 50 % ] to the EUC plus HAP group [ two of whom were subsequently excluded because of protocol violations ] and 248 [ 50 % ] to the EUC alone group ) , of whom 466 ( 95 % ) completed the 3 month primary outcome assessment ( 230 [ 49 % ] in the EUC plus HAP group and 236 [ 51 % ] in the EUC alone group ) . Participants in the EUC plus HAP group had significantly lower symptom severity ( Beck Depression Inventory version II in EUC plus HAP group 19·99 [ SD 15·70 ] vs 27·52 [ 13·26 ] in EUC alone group ; adjusted mean difference −7·57 [ 95 % CI −10·27 to −4·86 ] ; p<0·0001 ) and higher remission ( 147 [ 64 % ] of 230 had a PHQ-9 score of < 10 in the HAP plus EUC group vs 91 [ 39 % ] of 236 in the EUC alone group ; adjusted prevalence ratio 1·61 [ 1·34–1·93 ] ) than did those in the EUC alone group . EUC plus HAP showed better results than did EUC alone for the secondary outcomes of disability ( adjusted mean difference −2·73 [ –4·39 to −1·06 ] ; p=0·001 ) , days out of work ( −2·29 [ –3·84 to −0·73 ] ; p=0·004 ) , intimate partner physical violence in women ( 0·53 [ 0·29–0·96 ] ; p=0·04 ) , behavioural activation ( 2·17 [ 1·34–3·00 ] ; p<0·0001 ) , and suicidal thoughts or attempts ( 0·61 [ 0·45–0·83 ] ; p=0·001 ) . The incremental cost per quality -adjusted life-year gained was $ 9333 ( 95 % CI 3862–28 169 ; 2015 international dollars ) , with an 87 % chance of being cost-effective in the study setting . Serious adverse events were infrequent and similar between groups ( nine [ 4 % ] in the EUC plus HAP group vs ten [ 4 % ] in the EUC alone group ; p=1·00 ) . Interpretation HAP delivered by lay counsellors plus EUC was better than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa , India . HAP was readily accepted by this previously untreated population and was cost-effective in this setting . HAP could be a key strategy to reduce the treatment gap for depressive disorders , the leading mental health disorder worldwide . Funding Wellcome Trust Background Experiencing systematic violence and trauma increases the risk of poor mental health outcomes ; few interventions for these types of exposures have been evaluated in low re source context s. The objective of this r and omized controlled trial was to assess the effectiveness of two psychotherapeutic interventions , Behavioral Activation Treatment for Depression ( BATD ) and Cognitive Processing Therapy ( CPT ) , in reducing depression symptoms using a locally adapted and vali date d version of the Hopkins Symptom Checklist and dysfunction measured with a locally developed scale . Secondary outcomes included posttraumatic stress , anxiety , and traumatic grief symptoms . Methods Twenty community mental health workers , working in rural health clinics , were r and omly assigned to training in one of the two interventions . The community mental health workers conducted baseline assessment s , enrolled survivors of systematic violence based on severity of depression symptoms , and r and omly assigned them to treatment or waitlist-control . Blinded community mental health workers conducted post-intervention assessment s on average five months later . Results Adult survivors of systematic violence were screened ( N = 732 ) with 281 enrolled in the trial ; 215 r and omized to an intervention ( 114 to BATD ; 101 to CPT ) and 66 to waitlist-control ( 33 to BATD ; 33 to CPT ) . Nearly 70 % ( n = 149 ) of the intervention participants completed treatment and post-intervention assessment s ; 53 ( 80 % ) waitlist-controls completed post-intervention assessment s. Estimated effect sizes for depression and dysfunction were 0.60 and 0.55 respectively , comparing BATD participants to all controls and 0.84 and 0.79 respectively , compared to BATD controls only . Estimated effect sizes for depression and dysfunction were 0.70 and 0.90 respectively comparing CPT participants to all controls and 0.44 and 0.63 respectively compared to CPT controls only . Using a permutation-based hypothesis test that is robust to the model assumptions implicit in regression models , BATD had significant effects on depression ( p = .003 ) and dysfunction ( p = .007 ) , while CPT had a significant effect on dysfunction only ( p = .004 ) . Conclusions Both interventions showed moderate to strong effects on most outcomes . This study demonstrates effectiveness of these interventions in low re source environments by mental health workers with limited prior experience . Trial Registration Clinical Trials . Gov NCT00925262 . Registered June 3 , 2009 Providing survivors of torture , imprisonment , and /or military attacks with a counseling program that includes support , skills and psychoeducation by well-trained and supervised community mental health workers can result in moderate yet meaningful improvements in depression and dysfunction . Providing survivors of torture , imprisonment , and /or military attacks with a counseling program that includes support , skills and psychoeducation by well-trained and supervised community mental health workers can result in moderate yet meaningful improvements in depression and dysfunction . ABSTRACT Supportive counseling type interventions are frequently provided to meet the mental health needs of population s in emergency and post-conflicts context s , but it has seldom been rigorously evaluated . Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness . While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein ’s government , the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence . We evaluated the impact of a trauma-informed support , skills , and psychoeducation intervention provided by community mental health workers ( CMHWs ) on depressive symptoms and dysfunction ( primary outcomes ) as well as post-traumatic stress , traumatic grief , and anxiety symptoms ( secondary outcomes ) . Between June 2009 and June 2010 , 295 adults were screened ; 209 ( 71 % ) met eligibility criteria ( trauma exposure and a symptom severity score indicating significant distress and functional impairment , among others ) and consented to participate . Of these , 159 were r and omized to supportive counseling while 50 were r and omized to a waitlist control condition . Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group , the supportive counseling program had statistically and clinical ly significant impacts on the primary outcomes of depression ( Cohen ’s d , 0.57 ; P = .02 ) and dysfunction ( Cohen ’s d , 0.53 ; P = .03 ) and significant but smaller impacts on anxiety . Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects , this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support , skills , and psychoeducation that emphasizes the therapeutic relationship can also be effective Background Personalized healthcare relies on the identification of factors explaining why individuals respond differently to the same intervention . Analyses identifying such factors , so called predictors and moderators , have their own set of assumptions and limitations which , when violated , can result in misleading cl aims , and incorrect actions . The aim of this study was to develop a checklist for critically appraising the results of predictor and moderator analyses by combining recommendations from published guidelines and experts in the field . Methods C and i date criteria for the checklist were retrieved through systematic search es of the literature . These criteria were evaluated for appropriateness using a Delphi procedure . Two Delphi rounds yielded a pilot checklist , which was tested on a set of papers included in a systematic review on reinforced home-based palliative care . The results of the pilot informed a third Delphi round , which served to finalize the checklist . Results Forty-nine appraisal criteria were identified in the literature . Feedback was obtained from fourteen experts from (bio)statistics , epidemiology and other associated fields elicited via three Delphi rounds . Additional feedback from other research ers was collected in a pilot test . The final version of our checklist included seventeen criteria , covering the design ( e.g. a priori plausibility ) , analysis ( e.g. use of interaction tests ) and results ( e.g. complete reporting ) of moderator and predictor analysis , together with the transferability of the results ( e.g. clinical importance ) . There are criteria both for individual papers and for bodies of evidence . Conclusions The proposed checklist can be used for critical appraisal of reported moderator and predictor effects , as assessed in r and omized or non-r and omized studies using individual participant or aggregate data . This checklist is accompanied by a user ’s guide to facilitate implementation . Its future use across a wide variety of research domains and study types will provide insights about its usability and feasibility Background Gender-based violence ( GBV ) represents a major cause of psychological morbidity worldwide , and particularly in low- and middle-income countries ( LMICs ) . Although there are effective treatments for common mental disorders associated with GBV , they typically require lengthy treatment programs that may limit scaling up in LMICs . The aim of this study was to test the effectiveness of a new 5-session behavioural treatment called Problem Management Plus ( PM+ ) that lay community workers can be taught to deliver . Methods and findings In this single-blind , parallel , r and omised controlled trial , adult women who had experienced GBV were identified through community screening for psychological distress and impaired functioning in Nairobi , Kenya . Participants were r and omly allocated in a 1:1 ratio either to PM+ delivered in the community by lay community health workers provided with 8 days of training or to facility-based enhanced usual care ( EUC ) provided by community nurses . Participants were aware of treatment allocation , but research assessors were blinded . The primary outcome was psychological distress as measured by the total score on the 12-item General Health Question naire ( GHQ-12 ) assessed at 3 months after treatment . Secondary outcomes were impaired functioning ( measured by the WHO Disability Adjustment Schedule [ WHODAS ] ) , symptoms of posttraumatic stress ( measured by the Posttraumatic Stress Disorder Checklist [ PCL ] ) , personally identified problems ( measured by Psychological Outcome Profiles [ PSYCHLOPS ] ) , stressful life events ( measured by the Life Events Checklist [ LEC ] ) , and health service utilisation . Between 15 April 2015 and 20 August 2015 , 1,393 women were screened for eligibility on the basis of psychological distress and impaired functioning . Of these , 518 women ( 37 % ) screened positive , of whom 421 ( 81 % ) were women who had experienced GBV . Of these 421 women , 209 were assigned to PM+ and 212 to EUC . Follow-up assessment s were completed on 16 January 2016 . The primary analysis was intention to treat and included 53 women in PM+ ( 25 % ) and 49 women in EUC ( 23 % ) lost to follow-up . The difference between PM+ and EUC in the change from baseline to 3 months on the GHQ-12 was 3.33 ( 95 % CI 1.86–4.79 , P = 0.001 ) in favour of PM+ . In terms of secondary outcomes , for WHODAS the difference between PM+ and EUC in the change from baseline to 3-month follow-up was 1.96 ( 95 % CI 0.21–3.71 , P = 0.03 ) , for PCL it was 3.95 ( 95 % CI 0.06–7.83 , P = 0.05 ) , and for PSYCHLOPS it was 2.15 ( 95 % CI 0.98–3.32 , P = 0.001 ) , all in favour of PM+ . These estimated differences correspond to moderate effect sizes in favour of PM+ for GHQ-12 score ( 0.57 , 95 % CI 0.32–0.83 ) and PSYCHLOPS ( 0.67 , 95 % CI 0.31–1.03 ) , and small effect sizes for WHODAS ( 0.26 , 95 % CI 0.02–0.50 ) and PCL ( 0.21 , 95 % CI 0.00–0.41 ) . Twelve adverse events were reported , all of which were suicidal risks detected during screening . No adverse events were attributable to the interventions or the trial . Limitations of the study include no long-term follow-up , reliance on self-report rather than structured interview data , and lack of an attention control condition . Conclusions Among a community sample of women in urban Kenya with a history of GBV , a brief , lay-administered behavioural intervention , compared with EUC , result ed in moderate reductions in psychological distress at 3-month follow-up . Trial registration Australian New Zeal and Clinical Trials Registry Background Violence against women by intimate partners remains unacceptably common worldwide . The evidence base for the assumed psychological impacts of intimate partner violence ( IPV ) is derived primarily from studies conducted in high-income countries . A recently published systematic review identified 13 studies linking IPV to incident depression , none of which were conducted in sub-Saharan Africa . To address this gap in the literature , we analyzed longitudinal data collected during the course of a 3-y cluster-r and omized trial with the aim of estimating the association between IPV and depression symptom severity . Methods and Findings We conducted a secondary analysis of population -based , longitudinal data collected from 1,238 pregnant women during a 3-y cluster-r and omized trial of a home visiting intervention in Cape Town , South Africa . Surveys were conducted at baseline , 6 mo , 18 mo , and 36 mo ( 85 % retention ) . The primary explanatory variable of interest was exposure to four types of physical IPV in the past year . Depression symptom severity was measured using the Xhosa version of the ten-item Edinburgh Postnatal Depression Scale . In a pooled cross-sectional multivariable regression model adjusting for potentially confounding time-fixed and time-varying covariates , lagged IPV intensity had a statistically significant association with depression symptom severity ( regression coefficient b = 1.04 ; 95 % CI , 0.61–1.47 ) , with estimates from a quantile regression model showing greater adverse impacts at the upper end of the conditional depression distribution . Fitting a fixed effects regression model accounting for all time-invariant confounding ( e.g. , history of childhood sexual abuse ) yielded similar findings ( b = 1.54 ; 95 % CI , 1.13–1.96 ) . The magnitudes of the coefficients indicated that a one – st and ard-deviation increase in IPV intensity was associated with a 12.3 % relative increase in depression symptom severity over the same time period . The most important limitations of our study include exposure assessment that lacked measurement of sexual violence , which could have caused us to underestimate the severity of exposure ; the extended latency period in the lagged analysis , which could have caused us to underestimate the strength of the association ; and outcome assessment that was limited to the use of a screening instrument for depression symptom severity . Conclusions In this secondary analysis of data from a population -based , 3-y cluster-r and omized controlled trial , IPV had a statistically significant association with depression symptom severity . The estimated associations were relatively large in magnitude , consistent with findings from high-income countries , and robust to potential confounding by time-invariant factors . Intensive health sector responses to reduce IPV and improve women ’s mental health should be explored Background Intimate partner violence ( IPV ) is a critical public health and human rights concern globally , including for refugee women in low-re source setting s. Little is known about effective interventions for this population . IPV and psychological distress have a bi-directional relationship , indicating the potential benefit of a structured psychological component as part of efforts to reduce IPV for women currently in violent relationships . Methods This protocol describes a cluster r and omized controlled trial aim ed at evaluating an 8-session integrated psychological and advocacy intervention ( Nguvu ) with female adult survivors of past-year IPV displaying moderate to severe psychological distress . Outcomes are reductions in : recurrence of IPV ; symptoms of anxiety , depression and post-traumatic stress ( primary ) ; and functional impairment ( secondary ) . Hypothesized mediators of the intervention are improvements in social support , coping skills and support seeking . We will recruit 400 participants from existing women ’s support groups operating within villages in Nyarugusu refugee camp , Tanzania . Women ’s groups will be r and omized to receive the intervention ( Nguvu and usual care ) or usual care alone . All eligible women will complete a baseline assessment ( week 0 ) followed by a post-treatment ( week 9 ) and a 3-month post-treatment assessment ( week 20 ) . The efficacy of the intervention will be determined by between-group differences in the longitudinal trajectories of primary outcomes evaluated using mixed-effects models . Study procedures have been approved by Institutional Review Boards in the United States and Tanzania . Discussion This trial will provide evidence on the efficacy of a novel integrated group intervention aim ed at secondary prevention of IPV that includes a structured psychological component to address psychological distress . The psychological and advocacy components of the proposed intervention have been shown to be efficacious for their respective outcomes when delivered in isolation ; however , administering these approaches through a single , integrated intervention may result in synergistic effects given the interrelated , bidirectional relationship between IPV and mental health . Furthermore , this trial will provide information regarding the feasibility of implementing a structured intervention for IPV and mental health in a protracted humanitarian setting .Trial registration IS RCT N65771265 , June 27 , 2016 Background Secondary distress including emotional distress , vicarious trauma ( VT ) and secondary traumatic stress ( STS ) due to exposure to primary trauma victims have been described in helping professionals and in violence research ers . To our knowledge , there are few prevalence studies , and no tailored interventions have been tested to reduce secondary distress in violence research ers . The study aims to ( 1 ) describe the epidemiology of secondary distress experienced by violence research ers ; to ( 2 ) assess the effectiveness of group debriefings in mitigating secondary distress ; to ( 3 ) assess risk and protective factors . Methods We conducted an un-blinded , individually r and omised trial with parallel assignment . Eligible participants were 59 Ug and an research ers employed by the Good Schools Study to interview children who experienced violence in a district of Ug and a. Fifty-three research ers agreed to participate and were r and omly allocated . The intervention group ( n = 26 ) participated in three group debriefings and the control group ( n = 27 ) in three leisure sessions ( film viewings ) . The primary outcome was change in levels of emotional distress ( SRQ-20 ) ; secondary outcomes were levels of VT and STS at end-line . A paired t-test assessed the difference in mean baseline and end-line emotional distress . Un-paired t-tests compared the change in mean emotional distress ( baseline vs. end-line ) , and compared levels of VT and STS at end-line . Separate logistic regression models tested the association between end-line emotional distress and a-priori risk or protective factors . Results Baseline and end-line levels of emotional distress were similar in control ( p = 0.47 ) and intervention ( p = 0.59 ) groups . The superiority of group debriefing over leisure activities in lowering levels of emotional distress in the intervention group ( n = 26 ; difference in SRQ-20 = 0.23 [ SD = 2.18 ] ) compared to the control group ( n = 26 ; difference in SRQ-20 = 0.23 [ SD = 1.63 ] ) could not be detected ( p = 1 ) . In regression analysis ( n = 48 ) , baseline distress increased the odds of end-line distress ( OR = 16.1 , 95%CI 2.82 to 92.7 , p = 0.002 ) . Perceived organisational support ( OR = 0.09 , 95%CI 0.01 to 0.69 , p = 0.02 ) and belief in God ( OR = 0.21 , 95%CI 0.03 to 1.26 , p = 09 ) was protective against end-line distress . Conclusion We found no evidence that violence research ers experienced elevated emotional distress after doing violence research . There was no difference between group debriefings and leisure activities in reducing distress in our sample . However , the hypotheses presented should not be ruled out in other violence research setting s. Our findings suggest that organisational support is a significant protective factor and belief in God may be an important coping mechanism . Trial registration Clinical Trials NCT02390778 . Retrospectively registered 19 March 2015 . The Good Schools Trial was registered at ( NCT01678846 ) , on August 24 , 2012 BACKGROUND Mental health morbidity in post-conflict setting s is high . Nevertheless , r and omized controlled trials of psychotherapy on site are rare . Our aim was to integrate rigorous research procedures into a humanitarian programme and test the efficacy of re source activation ( ROTATE ) in treating post-traumatic stress disorder ( PTSD ) , co-morbid symptoms and impaired functioning in Cambodia . METHOD A total of 86 out- patients with PTSD were r and omly assigned to five sessions of ROTATE ( n = 53 ) or a 5-week waiting-list control ( WLC ) condition ( n = 33 ) . Treatment was provided by six Cambodian psychologists who had received extensive training in ROTATE . Masked assessment s were made before and after therapy . RESULTS PTSD remission rates according to the DSM-IV algorithm of the Harvard Trauma Question naire were 95.9 % in ROTATE and 24.1 % in the WLC condition . Thus , patients receiving ROTATE had a significantly higher likelihood of PTSD remission ( odds ratio 0.012 , 95 % confidence interval 0.002 - 0.071 , p < 0.00001 ) . Additionally , levels of anxiety , depression and impaired functioning were significantly reduced compared with the WLC condition ( p < 0.00001 , between-group effect sizes d = 2.41 , 2.26 and 2.54 , respectively ) . No harms were reported . CONCLUSIONS ROTATE was efficacious in treating Cambodian patients with high symptom levels of PTSD , emotional distress and impaired functioning . ROTATE is a brief , culturally adaptable intervention focusing on stabilization and strengthening re sources rather than trauma confrontation . It can be taught to local professionals and paraprofessionals and enhance access to mental health care for patients in need The purpose of this study was to evaluate treatment specificity and potential mediators of two online therapies for depressive symptoms . We conducted a r and omized controlled trial in which 263 participants were r and omized to online cognitive behavioral therapy ( CBT ) , online problem-solving therapy ( PST ) or a waiting list control group . Both treatments were more effective than the control group in reducing dysfunctional attitudes , worry , negative problem orientation and enhancing feelings of control . No differences between the treatments were found on each of the potential mediators . Furthermore , results suggest that dysfunctional attitudes , worrying , a negative problem orientation and perceived control all played a mediating role in CBT as well as in PST . Our findings suggest that regardless of the theoretical background to the therapy , the psychological processes necessary for symptom reduction seem to be comparable CONTEXT The psychological rehabilitation of former child soldiers and their successful reintegration into postconflict society present challenges . Despite high rates of impairment , there have been no r and omized controlled trials examining the feasibility and efficacy of mental health interventions for former child soldiers . OBJECTIVE To assess the efficacy of a community-based intervention targeting symptoms of posttraumatic stress disorder ( PTSD ) in formerly abducted individuals . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial recruiting 85 former child soldiers with PTSD from a population -based survey of 1113 Northern Ug and ans aged 12 to 25 years , conducted between November 2007 and October 2009 in camps for internally displaced persons . Participants were r and omized to 1 of 3 groups : narrative exposure therapy ( n = 29 ) , an academic catch-up program with elements of supportive counseling ( n = 28 ) , or a waiting list ( n = 28 ) . Symptoms of PTSD and trauma-related feelings of guilt were measured using the Clinician-Administered PTSD Scale . The respective sections of the Mini International Neuropsychiatric Interview were used to assess depression and suicide risk , and a locally adapted scale was used to measure perceived stigmatization . Symptoms of PTSD , depression , and related impairment were assessed before treatment and at 3 months , 6 months , and 12 months postintervention . INTERVENTION Treatments were carried out in 8 sessions by trained local lay therapists , directly in the communities . MAIN OUTCOME MEASURES Change in PTSD severity , assessed over a 1-year period after treatment . Secondary outcome measures were depression symptoms , severity of suicidal ideation , feelings of guilt , and perceived stigmatization . RESULTS PTSD symptom severity ( range , 0 - 148 ) was significantly more improved in the narrative exposure therapy group than in the academic catch-up ( mean change difference , -14.06 [ 95 % confidence interval , -27.19 to -0.92 ] ) and waiting-list ( mean change difference , -13.04 [ 95 % confidence interval , -26.79 to 0.72 ] ) groups . Contrast analyses of the time × treatment interaction of the mixed-effects model on PTSD symptom change over time revealed a superiority of narrative exposure therapy compared with academic catch-up ( F(1,234.1 ) = 5.21 , P = .02 ) and wait-listing ( F(1,228.3 ) = 5.28 , P = .02 ) . Narrative exposure therapy produced a larger within-treatment effect size ( Cohen d = 1.80 ) than academic catch-up ( d = 0.83 ) and wait-listing ( d = 0.81 ) . CONCLUSION Among former Ug and an child soldiers , short-term trauma-focused treatment compared either with an academic catch-up program including supportive counseling or with wait-listing result ed in greater reduction of PTSD symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00552006 OBJECTIVE The mental health needs of women affected by intimate partner violence ( IPV ) and living under continuous domestic violence are currently not well understood . The present study investigates the feasibility and efficacy of narrative exposure therapy ( NET ) , compared with commonly used counselling ( treatment-as-usual , TAU ) , in a group of currently IPV-affected women in Tehran , Iran . METHOD Forty-five IPV-affected women with a diagnosis of post-traumatic stress disorder ( PTSD ) were r and omized to 10 to 12 sessions of either NET ( n = 24 ) or TAU ( n = 21 ) . Primary outcome measures , including PTSD , depression , and perceived stress symptoms , were examined at pretreatment and 3- and 6-month follow-ups . IPV experiences , general lifetime traumatic events , childhood adversities , borderline symptoms , and daily functioning impairment were also inspected . RESULTS NET participants showed a significantly greater symptom reduction in comparison with the TAU group in PTSD , depression , and perceived stress at both follow-ups . Improvement in daily functioning and reduction of IPV experiences and borderline symptoms at 3- and 6-month follow-ups were pronounced but not significantly different between the two treatment groups . CONCLUSION IPV-affected women living under continuous threat and violence would benefit from trauma-focused interventions such as NET BACKGROUND The Thinking Healthy Programme ( THP ) , which is endorsed by WHO , is an evidence -based intervention for perinatal depression . We adapted THP for delivery by volunteer peers ( laywomen from the community ) to address the human re source needs in bridging the treatment gap , and we aim ed to assess its effectiveness and cost-effectiveness in Rawalpindi , Pakistan . METHODS In this cluster r and omised controlled trial , we r and omly assigned 40 village clusters ( 1:1 ) to provide either THP peer-delivered ( THPP ) and enhanced usual care ( EUC ; intervention group ) or EUC only ( control group ) to the participants within clusters . These villages were r and omly selected from eligible villages by an independent research er . The participants were pregnant women aged 18 years or older who had scored at least 10 on the Patient Health Question naire-9 ( PHQ-9 ) , who we recruited from households within communities in Rawalpindi , Pakistan . The research teams who were responsible for recruiting trial participants were masked to treatment allocations . Participants attended follow-up visits at 3 and 6 months after childbirth . The primary outcomes were the severity of depressive symptoms ( assessed by PHQ-9 score ) and the prevalence of remission ( defined as a PHQ-9 score of less than 5 ) in participants with available data 6 months after childbirth , which was assessed by research ers who were masked to treatment allocations . We analysed outcomes by intention to treat , adjusting for covariates that were defined a priori or that showed imbalance at baseline . The trial was registered with Clinical Trials.gov , number NCT02111915 . FINDINGS Between April 15 and July 30 , 2014 , we r and omly selected 40 of 46 eligible village clusters for assessment , as per sample size calculations . Between Oct 15 , 2014 , and Feb 25 , 2016 , we identified and screened 971 women from 20 village clusters that had been r and omly assigned to the THPP and EUC group and 939 women from 20 village clusters that had been r and omly assigned to the EUC only group . In the intervention group , 79 women were ineligible for inclusion , 11 women refused screening , 597 women screened negative on the PHQ-9 , and one woman did not consent to participate . In the control group , 75 women were ineligible for inclusion , 14 women refused screening , 562 women screened negative on the PHQ-9 , and one woman did not consent to participate . We enrolled 283 ( 29 % ) women in the intervention group and 287 ( 31 % ) women in the control group . At 6 months after childbirth , 227 ( 80 % ) women in the THPP and EUC group and 226 ( 79 % ) women in the EUC only group were assessed for the primary outcome . The severity of depression ( assessed by PHQ-9 scores ; st and ardised mean difference -0·13 , 95 % CI -0·31 to 0·06 ; p=0·07 ) and prevalence of remission ( 49 % in the intervention group vs 45 % in the control group ; prevalence ratio 1·12 , 95 % CI 0·95 to 1·29 ; p=0·14 ) did not significantly differ between the groups 6 months after childbirth . There was no evidence of significant differences in serious adverse events between the groups . INTERPRETATION THPP had no effect on symptom severity or remission from perinatal depression at 6 months after childbirth , but we found that it was beneficial on some other metrics of severity and disability and that it was cost-effective . THPP could be a step towards use of an unused human re source to address the treatment gap in perinatal depression . FUNDING National Institute of Mental Health ( USA ) BACKGROUND The Thinking Healthy Programme ( THP ) is a psychological intervention recommended for the treatment of perinatal depression . However , efforts to integrate the intervention at scale into the routines of community health workers who delivered the THP when it was first evaluated were compromised by the competing responsibilities of community health workers . We aim ed to assess the effectiveness and cost-effectiveness of THP peer-delivered ( THPP ) in Goa , India . METHODS In this single-blind , individually r and omised controlled trial , we recruited pregnant women aged 18 years or older who scored at least 10 on the Patient Health Question naire-9 ( PHQ-9 ) from antenatal clinics in Goa . Participants were r and omly allocated ( 1:1 ) to receive enhanced usual care ( EUC ; so-called because , in India , perinatal depression is not typically treated ) only ( control group ) or THPP in addition to EUC ( intervention group ) in r and omly sized blocks that were stratified by area of residence ( urban or rural ) . Group allocations were concealed from participants and research ers before assignments were made by use of sequentially numbered opaque envelopes . The primary outcomes were the severity of depressive symptoms ( assessed by PHQ-9 score ) and the prevalence of remission ( defined as a PHQ-9 score of less than 5 ) in participants with available data 6 months after childbirth , which was assessed by research ers who were masked to treatment allocations . We analysed outcomes by intention to treat , adjusting for covariates that were defined a priori or that showed imbalance at baseline . The trial is registered with Clinical Trials.gov , number NCT02104232 . FINDINGS Between Oct 24 , 2014 , and June 24 , 2016 , we assessed 118 260 women for their eligibility for screening , of whom 111 851 ( 94·6 % ) women were ineligible . 6409 ( 5·4 % ) women were eligible for screening and 6369 ( 99·4 % ) of these women consented to be screened with the PHQ-9 ( 40 women did not consent ) , of whom 333 ( 5·2 % ) screened positive for depression ( defined as a PHQ-9 score of at least 10 ) . We enrolled 280 ( 84·1 % ) women with perinatal depression ; 140 women were assigned to the THPP and EUC group and 140 women to the EUC only group . The final treatment was given on May 27 , 2017 . The final 6-month outcome assessment was completed on June 9 , 2017 . At 6 months after birth , 122 ( 87 % ) women in the THPP and EUC group and 129 ( 92 % ) women in the EUC only group were assessed for the primary outcome . There was a higher prevalence of remission at 6 months after birth in the THPP and EUC group compared with the EUC only group ( 89 [ 73 % ] women in the intervention group vs 77 [ 60 % ] women in the control group ; prevalence ratio 1·21 , 95 % CI 1·01 to 1·45 ; p=0·04 ) , but there was no evidence of a difference in symptom severity between the groups ( mean PHQ-9 score 3·47 [ SD 4·49 ] in the intervention group vs 4·48 [ 5·11 ] in the control group ; st and ardised mean difference -0·18 , 95 % CI -0·43 to 0·07 ; p=0·16 ) . There was no evidence of significant differences in serious adverse events between the groups . INTERPRETATION THPP had a moderate effect on remission from perinatal depression over the 6-month postnatal period . THPP is relatively cheap to deliver and is cost-saving through reduced health-care , time and productivity costs . FUNDING National Institute of Mental Health ( USA ) Importance Depression and anxiety are common mental disorders globally but are rarely recognized or treated in low-income setting s. Task-shifting of mental health care to lay health workers ( LHWs ) might decrease the treatment gap . Objective To evaluate the effectiveness of a culturally adapted psychological intervention for common mental disorders delivered by LHWs in primary care . Design , Setting , and Participants Cluster r and omized clinical trial with 6 months ' follow-up conducted from September 1 , 2014 , to May 25 , 2015 , in Harare , Zimbabwe . Twenty-four clinics were r and omized 1:1 to the intervention or enhanced usual care ( control ) . Participants were clinic attenders 18 years or older who screened positive for common mental disorders on the locally vali date d Shona Symptom Question naire ( SSQ-14 ) . Interventions The Friendship Bench intervention comprised 6 sessions of individual problem-solving therapy delivered by trained , supervised LHWs plus an optional 6-session peer support program . The control group received st and ard care plus information , education , and support on common mental disorders . Main Outcomes and Measures Primary outcome was common mental disorder measured at 6 months as a continuous variable via the SSQ-14 score , with a range of 0 ( best ) to 14 and a cutpoint of 9 . The secondary outcome was depression symptoms measured as a binary variable via the 9-item Patient Health Question naire , with a range of 0 ( best ) to 27 and a cutpoint of 11 . Outcomes were analyzed by modified intention-to-treat . Results Among 573 r and omized patients ( 286 in the intervention group and 287 in the control group ) , 495 ( 86.4 % ) were women , median age was 33 years ( interquartile range , 27 - 41 years ) , 238 ( 41.7 % ) were human immunodeficiency virus positive , and 521 ( 90.9 % ) completed follow-up at 6 months . Intervention group participants had fewer symptoms than control group participants on the SSQ-14 ( 3.81 ; 95 % CI , 3.28 to 4.34 vs 8.90 ; 95 % CI , 8.33 to 9.47 ; adjusted mean difference , -4.86 ; 95 % CI , -5.63 to -4.10 ; P < .001 ; adjusted risk ratio [ ARR ] , 0.21 ; 95 % CI , 0.15 to 0.29 ; P < .001 ) . Intervention group participants also had lower risk of symptoms of depression ( 13.7 % vs 49.9 % ; ARR , 0.28 ; 95 % CI , 0.22 to 0.34 ; P < .001 ) . Conclusions and Relevance Among individuals screening positive for common mental disorders in Zimbabwe , LHW-administered , primary care-based problem-solving therapy with education and support compared with st and ard care plus education and support result ed in improved symptoms at 6 months . Scaled-up primary care integration of this intervention should be evaluated . Trial Registration pactr.org Identifier : PACTR201410000876178 The study 's objective was to determine the effectiveness of a task-sharing psychological treatment for perinatal depression using non-specialist community health workers . A double-blind individual r and omised controlled trial was conducted in two antenatal clinics in the peri-urban settlement of Khayelitsha , Cape Town . Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale ( EPDS ) were r and omised into the intervention arm ( structured six-session psychological treatment ) or the control arm ( routine antenatal health care and three monthly phone calls ) . The primary outcome was response on the Hamilton Depression Rating Scale ( HDRS ) at three months postpartum ( minimum 40 % score reduction from baseline ) among participants who did not experience pregnancy or infant loss ( modified intention-to-treat population ) ( registered on Clinical Trials : NCT01977326 ) . Of 2187 eligible women approached , 425 ( 19.4 % ) screened positive on the EPDS and were r and omised ; 384 were included in the modified intention-to-treat analysis ( control : n = 200 ; intervention : n = 184 ) . There were no significant differences in response on the HDRS at three months postpartum between the intervention and control arm . A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha , South Africa . The findings give cause for reflection on the strategy of task-sharing in low-re source setting BACKGROUND Innovative solutions are required to provide mental health support at scale in low-re source humanitarian context s. We aim ed to assess the effectiveness of a facilitator-guided , group-based , self-help intervention ( Self-Help Plus ) to reduce psychological distress in female refugees . METHODS We did a cluster r and omised trial in rural refugee settlements in northern Ug and a. Participants were female South Sudanese refugees with at least moderate levels of psychological distress ( cutoff ≥5 on the Kessler 6 ) . The intervention comprised access to usual care and five 2-h audio-recorded stress-management workshops ( 20 - 30 refugees ) led by briefly trained lay facilitators , accompanied by an illustrated self-help book . Villages were r and omly assigned to either intervention ( Self-Help Plus or enhanced usual care ) on a 1:1 basis . Within 14 villages , r and omly selected households were approached . Screening of women in households continued until 20 - 30 eligible participants were identified per site . The primary outcome was individual psychological distress , assessed using the Kessler 6 symptom checklist 1 week before , 1 week after , and 3 months after intervention , in the intention-to-treat population . All outcomes were measured at the individual ( rather than cluster ) level . Secondary outcomes included personally identified problems , post-traumatic stress , depression symptoms , feelings of anger , social interactions with other ethnic groups , functional impairment , and subjective wellbeing . Assessors were masked to allocation . This trial was prospect ively registered at IS RCT N , number 50148022 . FINDINGS Of 694 eligible participants ( 331 Self-Help Plus , 363 enhanced usual care ) , 613 ( 88 % ) completed all assessment s. Compared with controls , we found stronger improvements for Self-Help Plus on psychological distress 3 months post intervention ( β -1·20 , 95 % CI -2·33 to -0·08 ; p=0·04 ; d -0·26 ) . We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes ( effect size range -0·30 to -0·36 ) . Refugees with different trauma exposure , length of time in settlements , and initial psychological distress benefited similarly . With regard to safety considerations , the independent data safety management board responded to six adverse events , and none were evaluated to be concerns in response to the intervention . INTERPRETATION Self-Help Plus is an innovative , facilitator-guided , group-based self-help intervention that can be rapidly deployed to large numbers of participants , and result ed in meaningful reductions in psychological distress at 3 months among South Sudanese female refugees . FUNDING Research for Health in Humanitarian Crises ( R2HC ) Programme |
1,312 | 24,390,240 | BRAF mutation decreases tumor response in first-line treatment whether cetuximab was given or not in patients with KRAS wild-type , and anti-EGFR MoAb produces a clear benefit in response rate in patients with BRAF and KRAS wild-type | Anti-EGFR monoclonal antibodies ( anti-EGFR MoAbs ) in metastatic colorectal cancer ( mCRC ) treatment are still not effective in all patients .
This study aim ed to evaluate the relationship between BRAF V600E mutation and the tumor response of anti-EGFR MoAbs for first-line treatment in mCRC patients . | PURPOSE In metastatic colorectal cancer , phase III studies have demonstrated the superiority of fluorouracil ( FU ) with leucovorin ( LV ) in combination with irinotecan or oxaliplatin over FU + LV alone . This phase III study investigated two sequences : folinic acid , FU , and irinotecan ( FOLFIRI ) followed by folinic acid , FU , and oxaliplatin ( FOLFOX6 ; arm A ) , and FOLFOX6 followed by FOLFIRI ( arm B ) . PATIENTS AND METHODS Previously untreated patients with assessable disease were r and omly assigned to receive a 2-hour infusion of l-LV 200 mg/m(2 ) or dl-LV 400 mg/m(2 ) followed by a FU bolus 400 mg/m(2 ) and 46-hour infusion 2,400 to 3,000 mg/m(2 ) every 46 hours every 2 weeks , either with irinotecan 180 mg/m(2 ) or with oxaliplatin 100 mg/m(2 ) as a 2-hour infusion on day 1 . At progression , irinotecan was replaced by oxaliplatin ( arm A ) , or oxaliplatin by irinotecan ( arm B ) . RESULT Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI ( P = .99 ) . Median second progression-free survival ( PFS ) was 14.2 months in arm A versus 10.9 in arm B ( P = .64 ) . In first-line therapy , FOLFIRI achieved 56 % response rate ( RR ) and 8.5 months median PFS , versus FOLFOX6 which achieved 54 % RR and 8.0 months median PFS ( P = .26 ) . Second-line FOLFIRI achieved 4 % RR and 2.5 months median PFS , versus FOLFOX6 which achieved 15 % RR and 4.2 months PFS . In first-line therapy , National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis , nausea/vomiting , and grade 2 alopecia were more frequent with FOLFIRI , and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6 . CONCLUSION Both sequences achieved a prolonged survival and similar efficacy . The toxicity profiles were different PURPOSE A traditional end point for colon adjuvant clinical trials is overall survival ( OS ) , with 5 years demonstrating adequate follow-up . A shorter-term end point providing convincing evidence to allow treatment comparisons could significantly speed the translation of advances into practice . METHODS Individual patient data were pooled from 18 r and omized phase III colon cancer adjuvant clinical trials . Trials included 43 arms , with a pooled sample size of 20,898 patients . The primary hypothesis was that disease-free survival ( DFS ) , with 3 years of follow-up , is an appropriate primary end point to replace OS with 5 years of follow-up . RESULTS The recurrence rates for years 1 through 5 were 12 % , 14 % , 8 % , 5 % , and 3 % , respectively . Median time from recurrence to death was 12 months . Eighty percent of recurrences were in the first 3 years ; 91 % of patients with recurrence by 3 years died before 5 years . Correlation between 3-year DFS and 5-year OS was 0.89 . Comparing control versus experimental arms within each trial , the correlation between hazard ratios for DFS and OS was 0.92 . Within-trial log-rank testing using both DFS and OS provided the same conclusion in 23 ( 92 % ) of 25 cases . Formal measures of surrogacy were satisfied . CONCLUSION In patients treated on phase III adjuvant colon clinical trials , DFS and OS are highly correlated , both within patients and across trials . These results suggest that DFS after 3 years of median follow-up is an appropriate end point for adjuvant colon cancer clinical trials of fluorouracil-based regimens , although marginally significant DFS improvements may not translate into significant OS benefits PURPOSE We performed this phase III study to compare the irinotecan , leucovorin ( LV ) , and fluorouracil ( FU ) regimen ( FOLFIRI ) versus the oxaliplatin , LV , and FU regimen ( FOLFOX4 ) in previously untreated patients with advanced colorectal cancer . PATIENTS AND METHODS A total of 360 chemotherapy-naive patients were r and omly assigned to receive , every 2 weeks , either arm A ( FOLFIRI : irinotecan 180 mg/m(2 ) on day 1 with LV 100 mg/m(2 ) administered as a 2-hour infusion before FU 400 mg/m(2 ) administered as an intravenous bolus injection , and FU 600 mg/m(2 ) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [ LV5FU2 ] ) or arm B ( FOLFOX4 : oxaliplatin 85 mg/m(2 ) on day 1 with LV5FU2 regimen ) . RESULTS One hundred sixty-four and 172 patients were assessable in arm A and B , respectively . Overall response rates ( ORR ) were 31 % in arm A ( 95 % CI , 24.6 % to 38.3 % ) and 34 % in arm B ( 95 % CI , 27.2 % to 41.5 % ; P = .60 ) . In both arms A and B , median time to progression ( TTP ; 7 v 7 months , respectively ) , duration of response ( 9 v 10 months , respectively ) , and overall survival ( OS ; 14 v 15 months , respectively ) were similar , without any statistically significant difference . Toxicity was mild in both groups : alopecia and gastrointestinal disturbances were the most common toxicities in arm A ; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms , and no statistical significant difference was observed . CONCLUSION There is no difference in ORR , TTP , and OS for patients treated with the FOLFIRI or FOLFOX4 regimen . Both therapies seemed effective as first-line treatment in these patients . The difference between these two combination therapies is mainly in the toxicity profile |
1,313 | 26,909,843 | There was significant variability in the definition of early and late decompression in both clinical and pre clinical studies .
Pre clinical data were in favor of early decompression .
From a clinical st and point , there was only level II evidence proving safety and feasibility of early decompression with no definite evidence of improved outcome for any of the two groups .
There is growing evidence in favor of early decompression following SCI .
Early decompression was proven to be clinical ly safe and feasible , but there is still no definite proof that early decompression leads to improved outcomes . | STUDY DESIGN A systematic review of the literature for clinical and pre clinical evidence related to timing of decompression following spinal cord injury ( SCI ) .
OBJECTIVE A review of the literature in search of consensus on what constitutes the ideal time frame for surgical management of SCI .
SUMMARY OF BACKGROUND DATA Optimal timing for surgical management of SCI remains poorly defined .
Despite multiple pre clinical and clinical studies , there is still lack of consensus on the optimal time for surgery in SCI . | Objectives : Pathophysiological mechanisms underlying spinal cord injury ( SCI ) partially involve edema and formation of a hematoma . Myelotomy seems to be a promising intervention . However , the appropriate timing of myelotomy is still unknown in SCI . Here we aim ed to determine the timing of microsurgical myelotomy in an animal model of SCI . Methods : The SCI model was contusion-induced with a new york university impactor . Sixty-five adult female rats were r and omly divided into the following groups : laminectomy alone ( the ‘ sham group ’ , SG ) , laminectomy plus contusion ( the ‘ contusion group ’ , CG ) or laminectomy plus contusion followed by myelotomy at 8 , 24 or 48 h ( 8 h-MTG [ myelotomy-treated group ] , 24 h-MTG or 48 h-MTG ) . Functional recovery was evaluated via the open field test and the inclined plane test every week after SCI . The percentage of spared white matter area ( SWMA ) and ultrastructure characteristics of the injured dorsolateral spinal cord were determined on the 42nd day after SCI . Results : Compared with the CG , myelotomy at 8 h-MTG or 24 h-MTG greatly improved the BASSO-BEATTIE- BRESNAHAN scores ( P<0.008 ) , whereas the 48 h-MTG showed less efficacy ( P=0.023 ) . All myelotomy groups showed higher mean angle values in an inclined plane test ( P<0.005 ) and had greater percentages of SWMA than the CG . Rats in the 24 h-MTG showed a higher intra-axonal fraction and myelin fraction than those in 48 h-MTG ( P<0.005 ) . Conclusion : Myelotomy up to 48 h after SCI improves recovery in rats . The potential time window of myelotomy may be between 8 and 24 h after SCI Background There is convincing pre clinical evidence that early decompression in the setting of spinal cord injury ( SCI ) improves neurologic outcomes . However , the effect of early surgical decompression in patients with acute SCI remains uncertain . Our objective was to evaluate the relative effectiveness of early ( < 24 hours after injury ) versus late ( ≥24 hours after injury ) decompressive surgery after traumatic cervical SCI . Methods We performed a multicenter , international , prospect i ve cohort study ( Surgical Timing in Acute Spinal Cord Injury Study : STASCIS ) in adults aged 16–80 with cervical SCI . Enrolment occurred between 2002 and 2009 at 6 North American centers . The primary outcome was ordinal change in ASIA Impairment Scale ( AIS ) grade at 6 months follow-up . Secondary outcomes included assessment s of complications rates and mortality . Findings A total of 313 patients with acute cervical SCI were enrolled . Of these , 182 underwent early surgery , at a mean of 14.2(±5.4 ) hours , with the remaining 131 having late surgery , at a mean of 48.3(±29.3 ) hours . Of the 222 patients with follow-up available at 6 months post injury , 19.8 % of patients undergoing early surgery showed a ≥2 grade improvement in AIS compared to 8.8 % in the late decompression group ( OR = 2.57 , 95 % CI:1.11,5.97 ) . In the multivariate analysis , adjusted for preoperative neurological status and steroid administration , the odds of at least a 2 grade AIS improvement were 2.8 times higher amongst those who underwent early surgery as compared to those who underwent late surgery ( OR = 2.83 , 95 % CI:1.10,7.28 ) . During the 30 day post injury period , there was 1 mortality in both of the surgical groups . Complications occurred in 24.2 % of early surgery patients and 30.5 % of late surgery patients ( p = 0.21 ) . Conclusion Decompression prior to 24 hours after SCI can be performed safely and is associated with improved neurologic outcome , defined as at least a 2 grade AIS improvement at 6 months follow-up Using data from the Second National Acute Spinal Cord Injury Study ( NASCIS II ) , the authors sought to characterize the role of surgery in the management of traumatic spinal cord injury and to examine the interaction between pharmacological treatment and surgery . Patients who did not undergo surgery had more severe spinal cord injuries initially than those who had surgery . However , no differences in neurological improvement at 1-year follow-up were found between those who underwent surgery and those who did not . The results suggest that either early surgery ( < or = 25 hours after injury ) or late surgery ( > 200 hours ) may be associated with increased neurological recovery , particularly motor function , but these results are equivocal . Surgery was not shown to interact with pharmacological treatments , indicating that the effect of drug treatment in NASCIS II , reported elsewhere , is not influenced by surgery . Other independent variables that best predicted improvement in motor score were age of 25 years or younger , incomplete injury , and lower baseline emergency department neurological scores . This study does not provide clinical ly relevant evidence concerning the efficacy of timing or the value of surgery in treating patients with spinal cord injuries . A r and omized study on the timing and efficacy of spinal cord surgery is needed to obtain valid comparisons of the efficacy of surgical treatments BACKGROUND CONTEXT Surgical treatment in the setting of central cord syndrome ( CCS ) has become safer since Schneider 's original description . It is generally accepted that a decompressive surgical intervention is a valid treatment option in a patient with CCS and radiographic evidence of spinal cord compression . The optimal timing of surgical intervention for CCS remains controversial . PURPOSE To review a single institution 's experience managing CCS , with particular emphasis on surgical versus medical management , timing of surgery , neurologic outcomes , hospital length of stay , and complications . STUDY DESIGN Retrospective review . PATIENT SAMPLE One hundred twenty-six patients diagnosed with CCS were treated at Wake Forest University Baptist Medical Center between June 1985 and September 2006 . OUTCOME MEASURES Neurological outcomes were measured using the Frankel grading scale . Other outcome measures included hospital and intensive care unit ( ICU ) length of stay and complication profiles . METHODS A retrospective chart review was performed on patients admitted to Wake Forest University Baptist Medical Center with the diagnosis of traumatic central cord injury from June 1985 to September 2006 with institutional review board approval . Neurologic status was recorded on presentation and at maximum follow-up using the Frankel classification . The surgical cohort was stratified into three subgroups with regard to the timing of surgical intervention after injury : surgery less than 24 hours after injury , surgery greater than 24 hours after injury but during the initial admission , and delayed operative intervention on a second hospital admission . Other variables collected included ICU and hospital length of stay and complication profiles . Data analyses were performed using SPSS ( SPSS , Chicago , IL , USA ) and Excel 2002 ( Microsoft , Seattle , WA , USA ) . RESULTS A total of 126 patients treated for CCS were review ed . Sixty-seven patients received surgery compared with 59 patients managed nonoperatively . Of those managed operatively , 16 patients received surgery within 24 hours of the time of injury . There were 34 patients who received surgery greater than 24 hours after the time of injury but during their initial admission with a mean time to surgery of 6.4 days ( 5 - 52 days ) . There were 17 patients who received their operation on a second hospital admission with a mean time interval of 137 days between injury and surgery ( 3 - 209 ) . Mean follow-up was 32 months ( 1 - 210 months ) . An improvement in Frankel grade was seen in the overall operative cohort compared with those patients who received medical management alone . No statistically significant difference in neurologic outcome using Frankel grade s was identified between the surgical subgroups with regard to timing of surgery . A trend toward decreased length of stay was seen in the surgical subgroup that received surgery during their initial admission . No statistically significant difference was identified between complication rates for the operative and nonoperative groups ; however , a trend toward fewer complications and deaths was seen in those who received surgery in the first 24 hours or during the initial hospitalization . CONCLUSIONS Surgical treatment in the setting of CCS has become safer since Schneider 's original description . Acknowledging its numerous limitations , this retrospective study supports surgical intervention in the setting of CCS as a safe effective management option . Improved Frankel grade s were identified in those patients managed surgically compared with those receiving medical management alone . The data further shed light on the safety and potential benefits of early operative intervention for acute CCS compared with delayed surgical treatment . A prospect i ve r and omized controlled trial is needed to definitively compare surgical versus medical management and /or early versus delayed surgical treatment in the setting of traumatic CCS Study Design Prospect i ve observational study . Purpose To assess the clinical outcome after early versus late decompression for traumatic cervical cord injury . Overview of Literature Traumatic spinal cord injury is common globally with the most tragic outcomes in the cervical spine . Although recent studies have shown that early decompression results in more favourable outcome , its authority is yet to be established . Methods Study on 98 patients with a traumatic cervical cord injury was conducted over a period of 5 years . The patients who were operated on within 24 hours of the onset of the primary injury ( n=34 ) were classified as the early group , and those who were operated on after 24 hours of the onset of the injury ( n=64 ) were categorized as the late group . The outcome of both the groups was assessed using the American Spinal Injury Association ( ASIA ) Impairment Scale ( AIS ) at the 6-month follow-up . Results The patients in the early group were operated on at a mean time of 18.4 hours ( range , 13 - 24 hours ) while patients were operated on at a mean time of 52.7 hours ( range , 31 - 124 hours ) in the late group . At the 6-month follow-up , 7 ( 23.3 % ) in the early group and 5 ( 8.7 % ) in the late group showed > 2 grade improvement in the AIS . Conclusions The results of patients undergoing decompression within 24 hours of the injury are better than those who are operated on later . An attempt should be made to decompress the traumatic cervical spine early in all possible cases STUDY DESIGN A prospect i ve , longitudinal study of multiply injured patients treated with segmental instrumentation for spinal fractures with a minimum 2-year follow-up . OBJECTIVES To determine whether urgent stabilization of spinal fractures in severely injured patients increases the risk of surgery compared with early treatment and historical results . SUMMARY AND BACKGROUND DATA Opinion in clinical studies is divided about whether operative treatment offers an advantage over nonoperative treatment in isolated spine fractures . Concomitant trauma is rarely discussed relative to decision making or surgical timing . Urgent stabilization of long-bone fractures improves survival and outcome in polytrauma patients . To date , urgent treatment of spine fractures in polytrauma patients has not been considered in the literature . METHODS Seventy-five consecutive patients treated with segmental instrumentation for spinal trauma were observed prospect ively to assess perioperative and longterm outcome . Twenty-seven patients with severe polytrauma ( injury severity score , > 26 ) were separately analyzed . Perioperative and postoperative results were analyzed relative to timing of surgery , injury severity score , and surgical approach . Urgent treatment was defined as that provided within 24 hours of the spinal injury , and early treatment was defined as that provided between 24 and 72 hours after injury . RESULTS Twenty-five patients ( 93 % ) sustained two or more major injuries in addition to the spine fracture , and 17 of 27 ( 63 % ) had neurologic injury . The mean injury severity score approached or exceeded the LD50 ( 50 % expected mortality ) in each group--36.0 for the early-treatment group and 42.0 for the urgent group -- but only one patient in each group died . There were no deep venous thromboses , pulmonary emboli , neurologic injuries , decubiti , deep wound infections , or episodes of sepsis in either group . Blood loss for anterior procedures was significantly higher in the urgent group , but estimated blood loss for posterior procedures was similar for both groups . At 49 months ' mean follow-up , no revisions were necessitated by the urgent spinal treatment . CONCLUSIONS Urgent spinal stabilization is safe and appropriate in polytrauma patients when progressive neurologic deficit , thoracoabdominal trauma , or fracture instability increase the risks of delayed treatment Study Design . A prospect i ve analysis evaluating neurologic outcome after early versus late surgery for cervical spinal cord trauma . Objectives . The study was conducted to determine whether neurologic and functional outcome is improved in traumatic cervical spinal cord‐injured patients ( C3‐T1 , American Spinal Injury Association grade s A‐D ) who had early surgery ( < 72 hours after spinal cord injury ) compared with those patients who had late surgery ( > 5 days after spinal cord injury ) . Summary of Background Data . There is considerable controversy as to the appropriate timing of surgical decompression and stabilization for cervical spinal cord trauma . There have been numerous retrospective studies , but no prospect i ve studies , to determine whether neurologic outcome is best after early versus late surgical treatment for cervical spinal cord injury . Methods . Patients meeting appropriate inclusion criteria were r and omized to an early ( < 72 hours after spinal cord injury ) or late ( > 5 days after spinal cord injury ) surgical treatment protocol . The neurologic and functional outcomes were recorded from the acute hospital admission to the most recent follow‐up . Results . Comparison of the two groups showed no significant difference in length of acute postoperative intensive care stay , length of inpatient rehabilitation , or improvement in American Spinal Injury Association grade or motor score between early ( mean , 1.8 days ) versus late ( mena , 16.8 days ) surgery . Conclusions . The results of this study reveal no significant neurologic benefit when cervical spinal cord decompression after trauma is performed less than 72 hours after injury ( mean , 1.8 days ) as opposed to waiting longer than 5 days ( mean , 16.8 days ) OBJECT A multicenter retrospective study was performed in 36 North American centers to examine the use and timing of surgery in patients who have sustained acute spinal cord injury ( SCI ) . The study was performed to obtain information required for the planning of a r and omized controlled trial in which early and late decompressive surgery are compared . METHODS The records of all patients aged 16 to 75 years with acute SCI admitted to 36 centers within 24 hours of injury over a 9-month period in 1994 and 1995 were examined to obtain data on admission variables , methods of diagnosis , use of traction , and surgical variables including type and timing of surgery . A total of 585 patients with acute SCI or cauda equina injury were admitted to participating centers , although approximately half were ultimately excluded because they did not meet inclusion criteria . Common causes for exclusion were late admission , age , gunshot wound , and absence of signs of compression on imaging studies . Thus , only approximately 50 % of patients with acute SCI would be eligible for inclusion in a study of acute decompressive surgery . Although all patients underwent computerized tomography ( CT ) scanning , only 54 % underwent magnetic resonance imaging , and CT myelography was performed in only 6 % . Complete neurological injuries ( American Spinal Injury Association Grade A ) were present in 57.8 % . Traction was applied in only 47 % of patients who sustained cervical injury , in whom decompressive traction was successful in only 42 % of cases . Neurological deterioration occurred in 8.1 % of cases after traction . Surgery was performed in 65.4 % of patients . The timing of surgery varied widely : less than 24 hours postinjury in 23.5 % , between 25 and 48 hours postinjury in 15.8 % , between 48 and 96 hours in 19 % , and more than 5 days postinjury in 41.7 % of patients . CONCLUSIONS These data indicate that although surgery is commonly performed in patients with acute SCI , one third of cases are managed nonoperatively , and there is very little agreement on the optimum timing of surgical treatment . The results of this study confirm the need for a r and omized controlled trial to assess the optimum timing of decompressive surgery in SCI To examine whether spinal cord decompression improves functional recovery and decreases lesion volumes in paraplegic ( not paraparetic ) rats and , if so , at what postoperative time it is most efficacious . The spinal cords of 63 female rats were compressed at T9 with Yasargil clips . Rats were assigned r and omly to five different treatment groups of 3 s , 1 hr , 6 hr , 3 weeks , and 10 weeks . Locomotor behavior scoring was based on the Basso , Beattie , Bresnahan ( BBB ) Locomotor Rating Scale ( Ohio State University , Columbus , OH ) motor scores . Comparing five groups , the mean BBB was statistically higher in the 3-s group ( P < 0.05 ) . Comparison of progressive changes in BBB in each group revealed statistically meaningful improvement in the 3-s group , too . Spared surface area of spinal cord was 81.5 ± 4.9 % in 3-s group and 10.8 ± 1.4 % in the delayed groups of decompression ( P = 0.039 ) . Rats undergoing immediate decompression showed significantly better functional recovery and smaller lesion volumes Study Design . Experimental dog model of acute spinal cord injury . Objective . To compare the relative value of methylprednisolone , surgical decompression , or both for the treatment of traumatic spinal cord injury . Summary of Background Data . Acute spinal cord injury results from both primary damage to the spinal cord at the time of the initial injury as well as a deleterious secondary cascade of events , which leads to further damage . Surgical decompression is known to improve clinical outcomes , but the timing of surgical decompression remains controversial . Methods . A nylon tie was used to constrict the spinal cord in 18 adult male beagle dogs . The animals were then prospect ively r and omized to 3 groups : 1 ) surgical decompression at 6 hours and intravenous methylprednisolone ; 2 ) surgical decompression at 6 hours and intravenous saline ; and 3 ) intravenous methylprednisolone without surgical decompression . Each animal was evaluated by somatosensory-evoked potentials , daily neurologic assessment , and histologic examination at 2 weeks following injury . Results . Immediately following spinal cord constriction , all animals were paraplegic , incontinent , and the somatosensory-evoked potentials were abolished . Surgical decompression 6 hours after injury , with or without methylprednisolone , led to significantly better neurologic function at 2 weeks than methylprednisolone alone . Conclusion . In the setting of acute and persistent spinal cord compression in beagle dogs , surgical decompression 6 hours after injury , with or without methylprednisolone , is more effective for improving neurologic recovery than methylprednisolone alone Acute spinal cord injury ( SCI ) is a major public health problem for which there is still only limited treatment available . The National Acute Spinal Cord Injury Study -2 ( NASCIS-2 ) and -3 clinical trials demonstrated that the use of acute pharmacotherapy with methylprednisolone can attenuate the secondary injury cascade if administered within 8 hours of acute SCI . However , no trial has been performed to examine whether acute surgical decompressive procedures within this critical 8-hour time window can improve patients ' neurological outcome . The purpose of the current prospect i ve Surgical Treatment for Acute Spinal Cord Injury Study ( STASCIS ) pilot study was to determine the feasibility of obtaining a radiological diagnosis of spinal canal compromise of 25 % or more and to perform spinal cord ( C3-T1 ) decompressive procedures by 8 hours postinjury . One of the following three decompressive methods was used : 1 ) traction alone ; 2 ) traction and surgery ; or 3 ) surgery alone . Twenty-six patients from eight North American centers were entered into the study between 1996 and 1997 . Significant difficulties were encountered in many centers in performing immediate magnetic resonance imaging examination in patients with acute SCI . Fewer than 10 % of acute cervical SCI patients could be enrolled into this protocol mainly because the combination of the required time for rescue , resuscitation , transport , imaging study , and surgical preparation exceeded the 8-hour injury-to-decompressive surgery window . Eleven patients underwent decompressive procedures initially by being placed in traction at a mean time of 10.9 hours postinjury . Those patients not undergoing this procedure underwent decompressive surgery at a mean time of 40.1 hours . However , the surgical decompressive procedure was completed within 12 hours in seven patients . As a result of these findings , several major changes have been made to the STASCIS protocol for early decompressive therapy BACKGROUND The effect of immediate surgical spinal cord decompression on neurologic outcome after spinal cord injury is controversial . Experimental models strongly suggest a beneficial effect of early decompression but there is little supportive clinical evidence . This study is design ed to evaluate the feasibility and outcome of an immediate spinal cord decompression treatment protocol for cervical spinal cord injury in a tertiary treatment center . METHODS To address this issue , 91 consecutive patients with acute , traumatic cervical spinal cord injury ( 1990 - 1997 ) were prospect ively studied . Sixty-six patients ( protocol group ) underwent emergency magnetic resonance imaging ( MRI ) to determine the presence of persistent spinal cord compression followed , if indicated , by immediate operative decompression and stabilization . Twenty-five patients were managed outside the treatment protocol because of contraindication to magnetic resonance imaging , need for other emergency surgical procedures , or admitting surgeon preference ( reference group ) . The protocol and reference groups had similar sex and age distributions , admitting Frankel grade s , levels of neurologic injury , and Injury Severity Scores . RESULTS Twenty-seven percent of patients seen were not enrolled in the treatment protocol because of the need for other emergent surgical treatment , contraindication to MRI , and specific surgeon bias regarding the " futility " of emergent treatment . The neurologic outcome for the patients in the reference group were similar to that in the previously reported literature . Fifty percent of protocol patients , compared with only 24 % of reference patients , improved from their admitting Frankel grade . Eight protocol patients ( 12 % ) , but no reference patients , improved from complete motor quadriplegia ( Frankel grade A or B ) to independent ambulation ( Frankel grade D or E ) . Protocol patients required shorter intensive care unit stays , and shorter total hospital stays than reference patients . In the treatment protocol group , spinal cord decompression , confirmed by MRI , was achieved with immediate spinal column alignment and skeletal traction in 32 patients ( 46 % ) . Thirty-four patients ( 54 % ) required emergent operative spinal cord decompression because of MRI-documented persistent spinal cord compression . CONCLUSION We conclude that immediate spinal column stabilization and spinal cord decompression , based on magnetic resonance imaging , may significantly improve neurologic outcome . The feasibility of such a treatment protocol in a tertiary treatment center is well demonstrated . Additional multicenter trials are necessary to achieve definitive conclusions regarding clinical efficacy |
1,314 | 21,821,503 | However , logins appeared to be the measure of adherence most consistently related to outcomes in physical health interventions , while module completion was found to be most related to outcomes in psychological health interventions .
There is large variation in the reporting of adherence and the association of adherence with outcomes .
Physical and psychological outcomes seem influenced by different types of adherence .
A composite measure encompassing time online , activity completion , and active engagements with the intervention may be the best measure of adherence . | BACKGROUND As the popularity of e-therapies grows , so too has the body of literature supporting their effectiveness .
However , these interventions are often plagued by high attrition rates and varying levels of user adherence .
Underst and ing the role of adherence may be crucial to underst and ing how program usage influences the effectiveness of e-therapy interventions .
OBJECTIVE The aim of this study was to systematic ally review the e-therapy literature to ( 1 ) describe the methods used to assess adherence and ( 2 ) evaluate the association of adherence with outcome of these interventions . | BACKGROUND Effective internet-based programs for depression usually incorporate a component that provides telephone or email contact . Open access websites , without such contact , show high rates of attrition and poorer outcomes . The present study was design ed as an exploratory investigation of the parameters that influence the effectiveness and retention of users on open access websites . We investigated whether brief cognitive behaviour therapy ( CBT ) was as effective as an extended version , whether add-on components of behaviour therapy or stress management contributed to positive outcomes , and whether longer programs were associated with greater attrition . METHOD An online r and omized controlled trial ( RCT ) was conducted between 13 January 2005 and 26 May 2005 ( 19 weeks ) . A total of 2794 registrants ( 1846 women and 948 men ; median age category 35 - 44 years ) with elevated scores on the Goldberg Depression Scale of 5.96 ( S.D.=2.09 ) elected online to be r and omized to one of six versions of a CBT website . The versions were compiled consisting of various components of brief CBT , extended CBT , behaviour strategies , stress management and problem solving . RESULTS A total of 20.4 % of participants completed the assigned intervention . The interaction of measurement occasion and treatment version was significant [ F(13,131)=2.20 , p=0.01 ] . A single module of brief introductory CBT was not effective in reducing depression symptoms . However , extended CBT with or without the addition of behaviour strategies result ed in the reduction of depression . CONCLUSIONS Brief CBT-based interventions are not as effective as extended interventions . However , longer programs are associated with higher rates of dropout Background Research increasingly supports the conclusion that well- design ed programs delivered over the Internet can produce significant weight loss compared to r and omized controlled conditions . Much less is known about four important issues addressed in this study : ( 1 ) which recruitment methods produce higher eHealth participation rates , ( 2 ) which patient characteristics are related to enrollment , ( 3 ) which characteristics are related to level of user engagement in the program , and ( 4 ) which characteristics are related to continued participation in project assessment s. Methods We recruited overweight members of three health maintenance organizations ( HMOs ) to participate in an entirely Internet-mediated weight loss program developed by HealthMedia , Inc. Two different recruitment methods were used : personal letters from prevention directors in each HMO , and general notices in member newsletters . The personal letters were sent to members diagnosed with diabetes or heart disease and , in one HMO , to a general membership sample in a particular geographic location . Data were collected in the context of a 2 × 2 r and omized controlled trial , with participants assigned to receive or not receive a goal setting intervention and a nutrition education intervention in addition to the basic program . Results A total of 2311 members enrolled . Bivariate analyses on aggregate data revealed that personalized mailings produced higher enrollment rates than member newsletters and that members with diabetes or heart disease were more likely to enroll than those without these diagnoses . In addition , males , those over age 60 , smokers , and those estimated to have higher medical expenses were less likely to enroll ( all P < .001 ) . Males and those in the combined intervention were less likely to engage initially , or to continue to be engaged with their Web program , than other participants . In terms of retention , multiple logistic regressions revealed that enrollees under age 60 ( P < .001 ) and those with higher baseline self-efficacy were less likely to participate in the 12-month follow-up ( P = .03 ) , but with these exceptions , those participating were very similar to those not participating in the follow-up . Conclusions A single personalized mailing increases enrollment in Internet-based weight loss . eHealth programs offer great potential for recruiting large numbers of participants , but they may not reach those at highest risk . Patient characteristics related to each of these important factors may be different , and more comprehensive analyses of determinants of enrollment , engagement , and retention in eHealth programs are needed BACKGROUND Subthreshold depression is a highly prevalent condition and a risk factor for developing a major depressive episode . Internet-based cognitive behaviour therapy may be a promising approach for the treatment of subthreshold depression . The current study had two aims : ( 1 ) to determine whether an internet-based cognitive behaviour therapy intervention and a group cognitive behaviour therapy intervention are more effective than a waiting-list control group ; and ( 2 ) to determine whether the effect of the internet-based cognitive behaviour therapy differs from the group cognitive behaviour therapy intervention . METHOD A total of 191 women and 110 men with subthreshold depression were r and omized into internet-based treatment , group cognitive behaviour therapy ( Lewinsohn 's Coping With Depression course ) , or a waiting-list control condition . The main outcome measure was treatment response after 10 weeks , defined as the difference in pre- and post-treatment scores on the Beck Depression Inventory ( BDI ) . Missing data , a major limitation of this study , were imputed using the Multiple Imputation ( MI ) procedure Data Augmentation . RESULTS In the waiting-list control group , we found a pre- to post-improvement effect size of 0.45 , which was 0.65 in the group cognitive behaviour therapy condition and 1.00 within the internet-based treatment condition . Helmert contrasts showed a significant difference between the waiting-list condition and the two treatment conditions ( p=0.04 ) and no significant difference between both treatment conditions ( p=0.62 ) . CONCLUSIONS An internet-based intervention may be at least as effective as a commonly used group cognitive behaviour therapy intervention for subthreshold depression in people over 50 years of age The Coronary Drug Project was carried out to evaluate the efficacy and safety of several lipid-influencing drugs in the long-term treatment of coronary heart disease . The five-year mortality in 1103 men treated with clofibrate was 20.0 per cent , as compared with 20.9 per cent in 2789 men given placebo ( P = 0.55 ) . Good adherers to clofibrate , i.e. , patients who took 80 per cent of more of the protocol prescription during the five-year follow-up period , had a substantially lower five-year mortality than did poor adherers to clofibrate ( 15.0 vs. 24.6 per cent ; P = 0.00011 ) . However , similar findings were noted in the placebo group , i.e. , 15.1 per cent mortality for good adherers and 28.3 per cent for poor adherers ( P = 4.7x10 - 16 ) . These findings and various other analyses of mortality in the clofibrate and placebo groups of the project show the serious difficulty , if not impossibility , of evaluating treatment efficacy in subgroups determined by patient responses ( e.g. , adherence or cholesterol change ) to the treatment protocol after r and omization CONTEXT Rapid increases in access to the Internet have made it a viable mode for public health intervention . No controlled studies have evaluated this re source for weight loss . OBJECTIVE To determine whether a structured Internet behavioral weight loss program produces greater initial weight loss and changes in waist circumference than a weight loss education Web site . DESIGN R and omized , controlled trial conducted from April to December 1999 . SETTING AND PARTICIPANTS Ninety-one healthy , overweight adult hospital employees aged 18 to 60 years with a body mass index of 25 to 36 kg/m(2 ) . Analyses were performed for the 65 who had complete follow-up data . INTERVENTIONS Participants were r and omly assigned to a 6-month weight loss program of either Internet education ( education ; n = 32 with complete data ) or Internet behavior therapy ( behavior therapy ; n = 33 with complete data ) . All participants were given 1 face-to-face group weight loss session and access to a Web site with organized links to Internet weight loss re sources . Participants in the behavior therapy group received additional behavioral procedures , including a sequence of 24 weekly behavioral lessons via e-mail , weekly online su bmi ssion of self-monitoring diaries with individualized therapist feedback via e-mail , and an online bulletin board . MAIN OUTCOME MEASURES Body weight and waist circumference , measured at 0 , 3 , and 6 months , compared the 2 intervention groups . RESULTS Repeated- measures analyses showed that the behavior therapy group lost more weight than the education group ( P = .005 ) . The behavior therapy group lost a mean ( SD ) of 4.0 ( 2.8 ) kg by 3 months and 4.1 ( 4.5 ) kg by 6 months . Weight loss in the education group was 1.7 ( 2.7 ) kg at 3 months and 1.6 ( 3.3 ) kg by 6 months . More participants in the behavior therapy than education group achieved the 5 % weight loss goal ( 45 % vs 22 % ; P = .05 ) by 6 months . Changes in waist circumference were also greater in the behavior therapy group than in the education group at both 3 months ( P = .001 ) and 6 months ( P = .005 ) . CONCLUSIONS Participants who were given a structured behavioral treatment program with weekly contact and individualized feedback had better weight loss compared with those given links to educational Web sites . Thus , the Internet and e-mail appear to be viable methods for delivery of structured behavioral weight loss programs BACKGROUND Major depression can be treated by means of cognitive-behavioural therapy , but as skilled therapists are in short supply there is a need for self-help approaches . Many individuals with depression use the internet for discussion of symptoms and to share their experience . AIMS To investigate the effects of an internet-administered self-help programme including participation in a monitored , web-based discussion group , compared with participation in web-based discussion group only . METHOD A r and omised controlled trial was conducted to compare the effects of internet-based cognitive-behavioural therapy with minimal therapist contact ( plus participation in a discussion group ) with the effects of participation in a discussion group only . RESULTS Internet-based therapy with minimal therapist contact , combined with activity in a discussion group , result ed in greater reductions of depressive symptoms compared with activity in a discussion group only ( waiting-list control group ) . At 6 months ' follow-up , improvement was maintained to a large extent . CONCLUSIONS Internet-delivered cognitive cognitive-behavioural therapy should be pursued further as a complement or treatment alternative for mild-to-moderate depression Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity BACKGROUND Computerised cognitive-behavioural therapy ( CCBT ) might offer a solution to the current undertreatment of depression . AIMS To determine the clinical effectiveness of online , unsupported CCBT for depression in primary care . METHOD Three hundred and three people with depression were r and omly allocated to one of three groups : Colour Your Life ; treatment as usual ( TAU ) by a general practitioner ; or Colour Your Life and TAU combined . Colour Your Life is an online , multimedia , interactive CCBT programme . No assistance was offered . We had a 6-month follow-up period . RESULTS No significant differences in outcome between the three interventions were found in the intention-to-treat and per protocol analyses . CONCLUSIONS Online , unsupported CCBT did not outperform usual care , and the combination of both did not have additional effects . Decrease in depressive symptoms in people with moderate to severe depression was moderate in all three interventions . Online CCBT without support is not beneficial for all individuals with depression In this paper we document the experience of participating in novel r and omised controlled trials for panic disorder - where face-to-face and Internet delivery of cognitive behavioural therapy are compared . Our analysis is based on 18 months of observation and in-depth interviews with 10 trial participants and 8 trialists in Victoria , Australia . We argue that the participants are positioned as active health consumers and approach the trial as they would other self-help practice s. High levels of individual responsibility are assumed of participants in these trials , which they accept by approaching the trials reflexively and search ing for information and strategies they can employ while building their health literacy on panic disorder . Although the research ers set the parameters of the treatment and interaction , increasingly the participants choose the extent to which they will comply with their defined role . For the participants the trial is one of the ' pick and mix ' options of available treatment and we suggest it is a compelling example of contemporary health consumption Background Psychoeducational programs are increasingly being delivered over the Internet . We created an Internet-based , cognitive therapy , self-help program to be used as a st and -alone intervention for mild-to-moderate depression , or as an adjunct to traditional services for more severe depression . Objective To evaluate the effectiveness of a web-based intervention program to reduce depression in a r and omized , controlled trial Methods In a private , nonprofit health maintenance organization , we mailed recruitment brochures to two population s : depressed adults ( n = 6994 ) who received traditional medical services for depression , and an age/gender matched sample of nondepressed adults ( n = 6996 ) . Participants consenting to the study were r and omized to either the experimental Web site ( n = 144 ) , or a no-access control group ( n = 155 ) . Participants in both groups were free to obtain nonexperimental , usual care services for their depression . All participants completed an on-line version of the Center for Epidemiological Studies Depression Scale ( CES-D ) at enrollment and at 4- , 8- , 16- and 32-weeks after enrollment . Mean intake scores were in the severely depressed range . 74 % of participants completed at least one follow-up assessment . Unfortunately , most intervention participants accessed the Internet site infrequently . Results We failed to find an effect for the Internet program across the entire sample . However , post-hoc , exploratory analyses revealed a modest effect among persons reporting low levels of depression at intake . Conclusions The negative results might have result ed from infrequent patient use of the Internet site , or a more seriously depressed sample than the intervention was intended to help . Future studies should focus on recruiting persons with mild to moderate levels of depression , and on increasing participant use of the Internet site Background Guided self-help programs for depression ( with associated therapist contact ) have been successfully delivered over the Internet . However , previous trials of pure self-help Internet programs for depression ( without therapist contact ) , including an earlier trial conducted by us , have failed to yield positive results . We hypothesized that methods to increase participant usage of the intervention , such as postcard or telephone reminders , might result in significant effects on depression . Objectives This paper presents a second r and omized trial of a pure self-help Internet site , ODIN ( Overcoming Depression on the InterNet ) , for adults with self-reported depression . We hypothesized that frequently reminded participants receiving the Internet program would report greater reduction in depression symptoms and greater improvements in mental and physical health functioning than a comparison group with usual treatment and no access to ODIN . Methods This was a three-arm r and omized control trial with a usual treatment control group and two ODIN intervention groups receiving reminders through postcards or brief telephone calls . The setting was a nonprofit health maintenance organization ( HMO ) . We mailed recruitment brochures by US post to two groups : adults ( n = 6030 ) who received depression medication or psychotherapy in the previous 30 days , and an age- and gender-matched group of adults ( n = 6021 ) who did not receive such services . At enrollment and at 5- , 10- and 16-weeks follow-up , participants were reminded by email ( and telephone , if nonresponsive ) to complete online versions of the Center for Epidemiological Studies Depression Scale ( CES-D ) and the Short Form 12 ( SF-12 ) . We also recorded participant HMO health care services utilization in the 12 months following study enrollment . Results Out of a recruitment pool of 12051 approached subjects , 255 persons accessed the Internet enrollment site , completed the online consent form , and were r and omized to one of the three groups : ( 1 ) treatment as usual control group without access to the ODIN website ( n = 100 ) , ( 2 ) ODIN program group with postcard reminders ( n = 75 ) , and ( 3 ) ODIN program group with telephone reminders ( n = 80 ) . Across all groups , follow-up completion rates were 64 % ( n = 164 ) at 5 weeks , 68 % ( n = 173 ) at 10 weeks , and 66 % ( n = 169 ) at 16 weeks . In an intention-to-treat analysis , intervention participants reported greater reductions in depression compared to the control group ( P = .03 ; effect size = 0.277 st and ard deviation units ) . A more pronounced effect was detected among participants who were more severely depressed at baseline ( P = .02 ; effect size = 0.537 st and ard deviation units ) . By the end of the study , 20 % more intervention participants moved from the disordered to normal range on the CES-D. We found no difference between the two intervention groups with different reminders in outcomes measures or in frequency of log-ons . We also found no significant intervention effects on the SF-12 or health care services . Conclusions In contrast to our earlier trial , in which participants were not reminded to use ODIN , in this trial we found a positive effect of the ODIN intervention compared to the control group . Future studies should address limitations of this trial , including relatively low enrollment and follow-up completion rates , and a restricted number of outcome measures . However , the low incremental costs of delivering this Internet program makes it feasible to offer this type of program to large population s with widespread Internet access Background Self-help therapies are often effective in reducing mental health problems . We developed a new Web-based self-help intervention based on problem-solving therapy , which may be used for people with different types of comorbid problems : depression , anxiety , and work-related stress . Objective The aim was to study whether a Web-based self-help intervention is effective in reducing depression , anxiety , and work-related stress ( burnout ) . Methods A total of 213 participants were recruited through mass media and r and omized to the intervention ( n = 107 ) or a waiting list control group ( n = 106 ) . The Web-based course took 4 weeks . Every week an automated email was sent to the participants to explain the contents and exercises for the coming week . In addition , participants were supported by trained psychology students who offered feedback by email on the completed exercises . The core element of the intervention is a procedure in which the participants learn to approach solvable problems in a structured way . At pre-test and post-test , we measured the following primary outcomes : depression ( CES-D and MDI ) , anxiety ( SCL-A and HADS ) , and work-related stress ( MBI ) . Quality of life ( EQ-5D ) was measured as a secondary outcome . Intention-to-treat analyses were performed . Results Of the 213 participants , 177 ( 83.1 % ) completed the baseline and follow-up question naires ; missing data were statistically imputed . Of all 107 participants in the intervention group , 9 % ( n = 10 ) dropped out before the course started and 55 % ( n = 59 ) completed the whole course . Among all participants , the intervention was effective in reducing symptoms of depression ( CES-D : Cohen ’s d = 0.50 , 95 % confidence interval ( CI ) 0.22 - 0.79 ; MDI : d = 0.33 , 95 % CI 0.03 - 0.63 ) and anxiety ( SCL-A : d = 0.42 , 95 % CI 0.14 - 0.70 ; HADS : d = 0.33 , 95 % CI 0.04 - 0.61 ) as well as in enhancing quality of life ( d = 0.31 , 95 % CI 0.03 - 0.60 ) . Moreover , a higher percentage of patients in the intervention group experienced a significant improvement in symptoms ( CES-D : odds ratio [ OR ] = 3.5 , 95 % CI 1.9 - 6.7 ; MDI : OR = 3.7 , 95 % CI 1.4 - 10.0 ; SCL-A : OR = 2.1 , 95 % CI 1.0 - 4.6 ; HADS : OR = 3.1 , 95 % CI 1.6 - 6.0 ) . Patients in the intervention group also recovered more often ( MDI : OR = 2.2 ; SCL-A : OR = 2.0 ; HADS < 8) , although these results were not statistically significant . The course was less effective for work-related stress , but participants in the intervention group recovered more often from burnout than those in the control group ( OR = 4.0 , 95 % CI 1.2 - 13.5 ) . Conclusions We demonstrated statistically and clinical ly significant effects on symptoms of depression and anxiety . These effects were even more pronounced among participants with more severe baseline problems and for participants who fully completed the course . The effects on work-related stress and quality of life were less clear . To our knowledge , this is the first trial of a Web-based , problem-solving intervention for people with different types of ( comorbid ) emotional problems . The results are promising , especially for symptoms of depression and anxiety . Further research is needed to enhance the effectiveness for work-related stress . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) Background Many depressed people do not receive help for their symptoms , and there are various barriers that impede help-seeking . The Internet may offer interesting alternatives for reaching and helping people with depression . Depression can be treated effectively with Internet-based cognitive behavioral therapy ( CBT ) , but a short intervention based on problem solving therapy ( PST ) could constitute a worthwhile alternative to CBT . Objective In this study we evaluated the effectiveness of Internet-based CBT and Internet-based PST in comparison to a waiting list control group ( WL ) , and we determined the differences between the two treatments . Methods We conducted a 3-arm r and omized controlled trial to compare CBT , PST , and WL . The main inclusion criterion was presence of depressive symptoms ( ≥ 16 on the Center for Epidemiological Studies Depression scale ) . CBT and PST consisted of eight and five weekly lessons respectively . Participants were supported by email . Self-report measures of depression , anxiety , and quality of life were completed at pretest and after 5 , 8 , and 12 weeks . Results A total of 263 participants were r and omized to the three conditions ( CBT : n=88 ; PST : n=88 ; WL : n=87 ) . Of the 263 participants , 184 ( 70 % ) completed question naires after 5 weeks , 173 ( 66 % ) after 8 weeks , and 151 ( 57 % ) after 12 weeks . Between-group effect sizes for depressive symptoms were 0.54 for CBT after 8 weeks ( 95 % confidence interval ( CI ) : 0.25 - 0.84 ) and 0.47 for PST after 5 weeks ( 95 % CI : 0.17 - 0.77 ) . These effects were further improved at 12 weeks ( CBT : 0.69 , 95 % CI : 0.41 - 0.98 ; PST : 0.65 , 95 % CI : 0.36 - 0.95 ) . For anxiety , effect sizes were also at a medium level . Effect sizes for quality of life were low . The number of participants showing clinical ly significant change at 12 weeks was significantly higher for CBT ( n = 34 , 38.6 % ) and PST ( n = 30 , 34.1 % ) , compared to WL ( n = 0 ) . Conclusions Both Internet-based treatments are effective in reducing depressive symptoms , although the effect of PST is realized more quickly . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 16823487 ; http://www.controlled-trials.com/IS RCT N16823487/16823487 ( Archived by WebCite at http://www.webcitation.org/5cQsOj7xf ) BACKGROUND Internet-delivered self-help programmes with added therapist guidance have shown efficacy in social anxiety disorder , but unguided self-help has been insufficiently studied . AIMS To evaluate the efficacy of guided and unguided self-help for social anxiety disorder . METHOD Participants followed a cognitive-behavioural self-help programme in the form of either pure bibliotherapy or an internet-based treatment with therapist guidance and online group discussion s. A subsequent trial was conducted to evaluate treatment specificity . Participants ( n = 235 ) were r and omised to one of three conditions in the first trial , or one of four conditions in the second . RESULTS Pure bibliotherapy and the internet-based treatment were better than waiting list on measures of social anxiety , general anxiety , depression and quality of life . The internet-based therapy had the highest effect sizes , but directly comparable effects were noted for bibliotherapy augmented with online group discussion s. Gains were well maintained a year later . CONCLUSIONS Unguided self-help through bibliotherapy can produce enduring improvement for individuals with social anxiety disorder BACKGROUND In a recent r and omized trial , we were unable to confirm the previously reported high effectiveness of CCBT . Therefore , the aim of the current study was to have a closer look at usage and acceptability ( i.e. expectancy , credibility , and satisfaction ) of the intervention . METHODS Depressed participants ( N=200 ) were given login codes for unsupported online CCBT . A track- and -trace system tracked which components were used . We used a 9-month follow-up period . RESULTS Uptake was sufficient , but dropout was high . Many usage indices were positively associated with short-term depressive improvement , whereas only homework was related to long-term improvement . Acceptability was good and expectancy could predict long-term , but not short-term outcome . LIMITATIONS Associations between use of CCBT and improvement are merely correlational . Our sample was too depressed in relation to the scope of the intervention . We relied on online self-report measures . Analyses were exploratory in nature . CONCLUSIONS Although CCBT might be a feasible and acceptable treatment for depression , means to improve treatment adherence are needed for moderately to severely depressed individuals Background Inactive people are often not aware of the fact that they are insufficiently active . Providing insight into their actual physical activity ( PA ) levels may raise awareness and could , in combination with tailored PA advice , stimulate a physically active lifestyle . Objective This study evaluated the feasibility and effectiveness of a 3-month intervention in which Dutch office workers were provided with a personal activity monitor ( PAM ) coupled to simple and concise Web-based tailored PA advice ( PAM COACH ) . Method Participants were r and omly assigned to the 3-month PAM intervention ( n = 51 ) or received a single written information brochure with brief general PA recommendations ( n = 51 ) . Study outcome measures were changes in PA ( recall of minutes per week spent on PA , as measured by the Activity Question naire for Adolescents and Adults ) , determinants of PA , aerobic fitness , and body composition . Follow-up measurements were performed immediately after the 3-month intervention and at 8-months , 5 months after the end of the 3-month intervention period . Results A total of 102 workers , 23 to 39 years old , completed the baseline measurement at the worksite . 48 completed the 3-month follow up and 38 the 8-month follow-up in the intervention group , 50 completed the 3-month follow up and 42 the 8-month follow up in the control group . 35 out of 48 ( 73 % ) participants in the PAM intervention group reported wearing the PAM regularly , and the PAM COACH was used almost once a week ; 24 out of 46 ( 52 % ) PAM users set a personal goal , and 33 ( 72 % ) entered their favorite activities on the website . Main reasons for not using these items were lack of interest or not being able to find the item on the website . The majority of PAM users ( 34 out of 46 , 74 % ) read the advice , of whom 14 ( 39 % ) found it unappealing . After the 3-month intervention , no significant intervention effect was observed ( adjusted difference in min/week ) for sedentary behavior ( β = 10 , 95 % CI = −435 to 455 ) , light-intensity PA ( β = −129 , 95 % CI = −337 to 79 ) , moderate-intensity PA ( β = −13 , 95 % CI = −89 to 63 ) , vigorous-intensity PA ( β= −6 , 95 % CI = −75 to 62 ) , and moderate- to vigorous-intensity PA ( β = −23 , 95 % CI = −121 to 76 ) . No significant intervention effect was observed in the PA outcomes at the 8-month follow-up . For the determinants of PA , aerobic fitness , and body composition , no statistically significant intervention effect was observed in the total study population immediately after the 3-month intervention or the 8-month follow-up . Conclusions The intervention appeared to be easily applicable to real-life setting s. The intervention was ineffective in improving PA behavior or its determinants in healthy office workers . More attention should have been given to the quality and appropriateness of the tailored advice . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 93896459 ; http://www.controlled-trials.com/IS RCT N93896459/ ( Archived by WebCite at http://www.webcitation.org/5iR3mf7ex CONTEXT Eating disorders , an important health problem among college-age women , may be preventable , given that modifiable risk factors for eating disorders have been identified and interventions have been evaluated to reduce these risk factors . OBJECTIVE To determine if an Internet-based psychosocial intervention can prevent the onset of eating disorders ( EDs ) in young women at risk for developing EDs . SETTING San Diego and the San Francisco Bay Area in California . PARTICIPANTS College-age women with high weight and shape concerns were recruited via campus e-mails , posters , and mass media . Six hundred thirty-seven eligible participants were identified , of whom 157 were excluded , for a total sample of 480 . Recruitment occurred between November 13 , 2000 , and October 10 , 2003 . Intervention A r and omized controlled trial of an 8-week , Internet-based cognitive-behavioral intervention ( Student Bodies ) that included a moderated online discussion group . Participants were studied for up to 3 years . MAIN OUTCOME MEASURES The main outcome measure was time to onset of a sub clinical or clinical ED . Secondary measures included change in scores on the Weight Concerns Scale , Global Eating Disorder Examination Question naire , and Eating Disorder Inventory drive for thinness and bulimia subscales and depressed mood . Moderators of outcome were examined . RESULTS There was a significant reduction in Weight Concerns Scale scores in the Student Bodies intervention group compared with the control group at postintervention ( P < .001 ) , 1 year ( P < .001 ) , and 2 years ( P < .001 ) . The slope for reducing Weight Concerns Scale score was significantly greater in the treatment compared with the control group ( P = .02 ) . Over the course of follow-up , 43 participants developed sub clinical or clinical EDs . While there was no overall significant difference in onset of EDs between the intervention and control groups , the intervention significantly reduced the onset of EDs in 2 subgroups identified through moderator analyses : ( 1 ) participants with an elevated body mass index ( BMI ) ( > or = 25 , calculated as weight in kilograms divided by height in meters squared ) at baseline and ( 2 ) at 1 site , participants with baseline compensatory behaviors ( eg , self-induced vomiting , laxative use , diuretic use , diet pill use , driven exercise ) . No intervention participant with an elevated baseline BMI developed an ED , while the rates of onset of ED in the comparable BMI control group ( based on survival analysis ) were 4.7 % at 1 year and 11.9 % at 2 years . In the subgroup with a BMI of 25 or higher , the cumulative survival incidence was significantly lower at 2 years for the intervention compared with the control group ( 95 % confidence interval , 0 % for intervention group ; 2.7 % to 21.1 % for control group ) . For the San Francisco Bay Area site sample with baseline compensatory behaviors , 4 % of participants in the intervention group developed EDs at 1 year and 14.4 % , by 2 years . Rates for the comparable control group were 16 % and 30.4 % , respectively . CONCLUSIONS Among college-age women with high weight and shape concerns , an 8-week , Internet-based cognitive-behavioral intervention can significantly reduce weight and shape concerns for up to 2 years and decrease risk for the onset of EDs , at least in some high-risk groups . To our knowledge , this is the first study to show that EDs can be prevented in high-risk groups BACKGROUND Less than half of U.S. adults engage in the recommended amount of physical activity ( PA ) . Internet-delivered PA programs increase short-term PA but long-term adherence is largely equivocal . PURPOSE To determine whether increased PA following the 16-week Internet-delivered Active Living Every Day ( ALED-I ) program is maintained 8 months later in sedentary and overweight rural adults . METHODS In our previous r and omized controlled trial ( N = 32 ; 18 intent-to-treat controls , 14 ALED-I interventions ) , the ALED-I group increased PA ( + 1384 steps/day ; E.S. = 0.95 ) and reduced central adiposity . Nine original intervention participants and ten delayed intent-to-treat control participants completed ALED-I and an 8-month followup . Pedometer-measured PA , anthropometric variables , and cardiometabolic disease risk factors were assessed at baseline , postintervention , and at 8 months . RESULTS Control crossover participants increased PA ( + 1337 steps/ day ; P = .04 ) . Eight months following completion of ALED-I ( N = 19 ) , PA levels relapsed ( -1340 steps/day ) and were similar to levels before the intervention ( 6850 + /- 471 steps/day vs. 6755 + /- 543 steps/day ; P = .89 ) . Total cholesterol and triglycerides improved , -9.9 % and -18.2 % , respectively , and reductions in central adiposity were maintained ( 97.1 + /- 2.2 cm vs. 97.2 + /- 2.2 cm ; P = .66 ) . CONCLUSIONS The ALED-I intervention was efficacious in the short-term but did not produce longer-term adherence to PA . Future theory-based internet-delivered interventions that produce habituation of increased PA are warranted The sizeable percentage of adults who use smokeless tobacco ( ST ) represents an important public health target since the majority of ST users have a strong desire to quit , but many lack re sources . We tested the impact of an interactive , tailored Web-based intervention ( Enhanced Condition ) versus a more linear , text-based website ( Basic Condition ) in a r and omized trial with 2523 adult ST users . As is common in Internet-based research , there was considerable attrition : follow-up rates at 3 months , 6 months , and for both 3 and 6 months were 48 % , 45 % and 34 % , respectively . Results using repeated point prevalence of all tobacco use at 3 and 6 months showed that participants in the Enhanced Condition quit at significantly higher rates than those in the Basic Condition . Using a Complete Case analysis , abstinence was 40.6 % in the Enhanced Condition vs. 21.2 % in the Basic Condition ( p < .001 ) . Using intent-to-treat analysis , quit rates were 12.6 % vs. 7.9 % , respectively ( p < .001 ) . Similar results were obtained for only ST use . Unobtrusive measures of program exposure indicated that program use was significantly related to outcome as well as to attrition . We conclude that a tailored , interactive Web-assisted cessation program can be an efficacious method for assisting adult ST users to quit Background Smoking cessation remains a significant public health problem . Innovative interventions that use the Internet have begun to emerge that offer great promise in reaching large numbers of participants and encouraging widespread behavior change . To date , the relatively few controlled trials of Web-based smoking cessation programs have been limited by short follow-up intervals . Objective We describe the 6-month follow-up results of a r and omized controlled trial in which participants recruited online were r and omly assigned to either a Web-based smoking cessation program ( Quit Smoking Network ; QSN ) or a Web-based exercise enhancement program ( Active Lives ) adapted somewhat to encourage smoking cessation . Methods The study was a two-arm r and omized controlled trial that compared two Web-based smoking cessation programs : ( 1 ) the QSN intervention condition presented cognitive-behavioral strategies , and ( 2 ) the Active Lives control condition provided participants with guidance in developing a physical activity program to assist them with quitting . The QSN condition provided smoking cessation information and behavior change strategies while the Active Lives condition provided participants with physical activity recommendations and goal setting . The QSN condition was design ed to be more engaging ( eg , it included multimedia components ) and to present much greater content than is typically found in smoking cessation programs . Results Contrary to our hypotheses , no between-condition differences in smoking abstinence were found at 3- and 6-month follow-up assessment s. While participants in the QSN intervention condition spent more time than controls visiting the online program , the median number of 1.0 visit in each condition and the substantial attrition ( 60.8 % at the 6-month follow-up ) indicate that participants were not as engaged as we had expected . Conclusions Contrary to our hypothesis , our test of two Web-based smoking cessation conditions , an intervention and an attention placebo control , failed to show differences at 3- and 6-month assessment s. We explored possible reasons for this finding , including limited engagement of participants and simplifying program content and architecture . Future research needs to address methods to improve participant engagement in online smoking cessation programs . Possible approaches in this regard can include new informed consent procedures that better explain the roles and responsibilities of being a research participant , new program design s that add more vitality ( changing content from visit to visit ) , and new types of reminders pushed out to participants to encourage return visits . Simplifying program content through a combination of enhanced tailoring and information architecture also merits further research attention Background In r and omized controlled trials Internet sites have been shown to be effective in the treatment of depression and anxiety . However , it is unclear if the positive effects demonstrated in these trials transfer to community users of such sites . Objective To compare anxiety and depression outcomes for spontaneous visitors to a publicly accessible cognitive behavior therapy website ( MoodGYM ) ( http://moodgym.anu.edu.au ) with outcomes achieved through a r and omized controlled efficacy trial of the same site . Methods All community visitors to the MoodGYM site between April 2001 and September 2003 were sample d : 182 participants in the BlueMood Trial who had been r and omly assigned to the MoodGYM site as part of a large trial and 19607 visitors ( public registrants ) to the site . Symptom assessment s ( quizzes ) were repeated within the website intervention to allow the examination of change in symptoms across modules . Outcome variables were ( 1 ) age , gender , initial depression severity scores , and number of assessment s attempted , and ( 2 ) symptom change measures based on Goldberg anxiety and depression scores recorded on a least two occasions . Results Public registrants did not differ from trial participants in gender , age , or initial level of depression , which was high for both groups relative to previously published epidemiological data sets . Trial participants completed more assessment s. No significant differences in anxiety or depression change scores were observed , with both public registrants and trial participants improving through the training program . Conclusions Public registrants to a cognitive behavior therapy website show significant change in anxiety and depression symptoms . The extent of change does not differ from that exhibited by participants enrolled on the website for a r and omized controlled trial This study evaluated an Internet-delivered computer-assisted health education ( CAHE ) program design ed to improve body satisfaction and reduce weight/shape concerns -- concerns that have been shown to be risk factors for the development of eating disorders in young women . Participants were 60 women at a public university r and omly assigned to either an intervention or control condition . Intervention participants completed the CAHE program Student Bodies . Measures of body image and disordered eating attitudes were assessed at baseline , postintervention , and 3-month follow-up . At follow-up , intervention participants , compared with controls , reported a significant improvement in body image and a decrease in drive for thinness . This program provides evidence for the feasibility and effectiveness of providing health education by means of the Internet The Internet is a relatively new method of delivering strategies for health behavior change . The purpose of this study was to determine the feasibility of delivering a physical activity intervention by the Internet to improve outcomes in adults with the metabolic syndrome . Twenty-two participants ( 16 males ; 6 females ) were recruited from a cardiology clinic data base , age range 32 - 66 years . Participants were r and omly assigned to the Internet intervention ( n = 12 ) or the usual care ( n = 10 ) group . The mean total dose , in terms of the time the intervention Web site was accessed was 2 hours over 6 weeks , which was greater than the time spent delivering usual care . Overall , participants ' evaluations of the Internet intervention were positive . The costs of development and delivery of the Internet intervention were less than that of a consultation and follow-up in the cardiology clinic for this sample . The Internet intervention appears feasible for testing in a larger study The relation of treatment adherence to mortality after a myocardial infa rct ion was investigated among 2175 participants in the Beta Blocker Heart Attack Trial , which had data for measures of treatment adherence , clinical severity , and the psychological and social features that may influence post-infa rct ion mortality . Overall , patients who did not adhere well to treatment regimen ( ie , who took less than or equal to 75 % of prescribed medication ) were 2.6 times more likely than good adherers to die within a year of follow-up ( 95 % confidence interval , 1.2 , 5.6 ) . Poor adherers had an increased risk of death whether they were on propranolol ( OR = 3.1 ) or placebo ( OR = 2.5 ) . Furthermore , this increased risk of death for poor adherers was not accounted for by measures of the severity of myocardial infa rct ion , sociodemographic features ( eg , race , marital status , education ) , smoking , or psychological characteristics ( high life-stress or social isolation ) OBJECTIVE Alcohol misuse amongst University students is a serious concern , and research has started to investigate the feasibility of using e-health interventions . This study aim ed to establish the effectiveness of an electronic web-based personalised feedback intervention through the use of a r and omised control trial ( RCT ) . METHODS 506 participants were stratified by gender , age group , year of study , self-reported weekly consumption of alcohol and r and omly assigned to either a control or intervention condition . Intervention participants received electronic personalised feedback and social norms information on their drinking behaviour which they could access by logging onto the website at any time during the 12-week period . CAGE score , average number of alcoholic drinks consumed per drinking occasion , and alcohol consumption over the last week were collected from participants at pre- and post-survey . RESULTS A significant difference in pre- to post-survey mean difference of alcohol consumed per occasion was found , with those in the intervention condition displaying a larger mean decrease when compared to controls . No intervention effect was found for units of alcohol consumed per week or for CAGE scores . Sixty-three percent of intervention participants agreed that the feedback provided was useful . Those intervention participants who were above the CAGE cut off were more likely to report that the website would make them think more about the amount they drank . CONCLUSIONS Delivering an electronic personalised feedback intervention to students via the World Wide Web is a feasible and potentially effective method of reducing student alcohol intake . Further research is needed to replicate this outcome , evaluate maintenance of any changes , and investigate the process of interaction with web-based interventions Background : The efficacy of cognitive behaviour therapy ( CBT ) in social phobia has been demonstrated in several controlled trials and meta-analyses , but no comparison of CBT with supportive therapy ( ST ) can be found in the literature . Method : The aim of the trial was to study the effectiveness of CBT versus ST carried out ‘ as usual ’ . Sixty-seven DSM-4 social phobic patients ( 89 % generalized subtype , most with avoidant personality ) were r and omly allocated into two groups . Group 1 ( CBT ) received 8 1-hour sessions of individual cognitive therapy ( CT ) for 6 weeks , followed by 6 2-hour sessions of social skills training ( SST ) in group weekly . Group 2 received ST for 12 weeks ( 6 half-hour sessions ) , then the patients were switched to CBT . All patients agreed not to take any medication during the whole trial . In group 1 , 29 patients reached week 6 , 27 reached week 12 , and 24 weeks 36 and 60 ( endpoint ) . In group 2 , 29 patients reached week 6 , 28 reached weeks 12 and 18 , 26 week 24 , and 23 reached weeks 48 and 72 ( endpoint ) . Results : At week 6 , after CT , group 1 was better than group 2 on the main social phobia measure . At week 12 , after SST , group 1 was better than group 2 on most of the measures and demonstrated a significantly higher rate of responders . This finding was replicated after switching group 2 to CBT . Sustained improvement was observed in both groups at follow-up . Compliance with abstinence from medication increased over time . Conclusions : CBT was more effective than ST and demonstrated long-lasting effects . This may suggest that social phobia management requires more than a simple and inexpensive psychological intervention OBJECTIVE Because of other competing priorities , physical activity ( PA ) is seldom addressed in a consistent way in either primary care or diabetes education . This 8-week pilot study evaluated the short-term benefits of an Internet-based supplement to usual care that focused on providing support for sedentary patients with type 2 diabetes to increase their PA levels . RESEARCH DESIGN AND METHODS A total of 78 type 2 diabetic patients ( 53 % female , average age 52.3 years ) were r and omized to the Diabetes Network ( D-Net ) Active Lives PA Intervention or an Internet information-only condition . The intervention condition received goal - setting and personalized feedback , identified and developed strategies to overcome barriers , received and could post messages to an on-line " personal coach , " and were invited to participate in peer group support areas . Key outcomes included minutes of PA per week and depressive symptomatology . RESULTS There was an overall moderate improvement in PA levels within both intervention and control conditions , but there was no significant improvement in regard to condition effects . There was substantial variability in both site use and outcomes within the intervention and control conditions . Internal analyses revealed that among intervention participants , those who used the site more regularly derived significantly greater benefits , whereas those in the control condition derived no similar benefits with increased program use . CONCLUSIONS Internet-based self-management interventions for PA and other regimen areas have great potential to enhance the care of diabetes and other chronic conditions . We conclude that greater attention should be focused on methods to sustain involvement with Internet-based intervention health promotion programs over time BACKGROUND Physical activity interventions tailored to individual characteristics and delivered via print produce greater increases in activity compared with nontailored interventions and controls . Using the Internet to deliver a tailored physical activity intervention offers an alternative to print that might be available to larger population s at a lower cost . METHODS Participants ( N=249 adults ; mean [ SD ] age , 44.5 [ 9.3 ] years ; and mean [ SD ] body mass index [ calculated as weight in kilograms divided by height in meters squared ] , 29.4 [ 6.1 ] ) were r and omized to 1 of 3 physical activity interventions : ( 1 ) motivationally tailored Internet ( tailored Internet , n=81 ) , ( 2 ) motivationally tailored print ( tailored print , n=86 ) ; and ( 3 ) 6 research er-selected Web sites available to the public ( st and ard Internet , n=82 ) . Participants in the tailored Internet and tailored print arms received the same tailored intervention content . Participants were assessed at baseline and at 6 and 12 months . RESULTS At 6 months , participants in the tailored print arm reported a median of 112.5 minutes of physical activity per week , those in the tailored Internet arm reported 120.0 minutes , and those in the st and ard Internet arm reported 90.0 minutes ( P=.15 ) . At 12 months , the physical activity minutes per week were 90.0 , 90.0 , and 80.0 for those in the tailored print , tailored Internet , and st and ard Internet arms , respectively ( P=.74 ) . Results indicated no significant differences between the 3 arms . CONCLUSIONS The use of tailored Internet , tailored print , and st and ard Internet as part of a behavior change program increased physical activity behavior similarly . Because the use of the Internet was not different from the print-based intervention , this may be an opportunity to reach more sedentary adults in a more cost-effective way . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00200317 Objective : In two previous r and omized controlled trials Titov et al. demonstrated significant benefit from an Internet- and email-based treatment programme for social phobia . The present study ( Shyness 3 ) explores whether participants are able to complete this programme independently . Method : A total of 98 individuals with social phobia were r and omly assigned to a clinician-assisted computerized cognitive behavioural treatment ( CaCCBT ) group , a self-guided computerized CBT ( CCBT ) group , or to a waitlist control group . CaCCBT group participants completed the usual Shyness programme consisting of six online lessons , cognitive behavioural homework assignments , email contact with a therapist , and participation in an online discussion forum . CCBT group participants accessed the same re sources except for therapist emails . An intention-to-treat model was used for data analyses . Results : A total of 77 % of CaCCBT and 33 % of CCBT group participants completed all lessons . Significant differences were found after treatment between CaCCBT and control groups ( mean between-groups effect size ( ES ) for the social phobia measures = 1.04 ) , and between the CaCCBT and CCBT groups ( mean between-groups ES for the social phobia measures = 0.66 ) . No significant differences were found after treatment between the CCBT and control groups ( mean between-groups ES for the social phobia measures = 0.38 ) . CCBT participants , however , who completed the six lessons made good progress ( mean within-group ES for the social phobia measures = 0.62 ) . Quantitative and qualitative data indicate that both the CaCCBT and CCBT procedures were acceptable to participants . Conclusions : The reliability of this Internet-based treatment programme for social phobia has been confirmed . The therapist-guided condition was superior to the self-guided condition , but a subgroup of participants still benefited considerably from the latter . These data confirm that self-guided education or treatment programmes for common anxiety disorders can result in significant improvements CONTEXT Weight loss programs on the Internet appear promising for short-term weight loss but have not been studied for weight loss in individuals at risk of type 2 diabetes ; thus , the longer-term efficacy is unknown . OBJECTIVE To compare the effects of an Internet weight loss program alone vs with the addition of behavioral counseling via e-mail provided for 1 year to individuals at risk of type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS A single-center r and omized controlled trial conducted from September 2001 to September 2002 in Providence , RI , of 92 overweight adults whose mean ( SD ) age was 48.5 ( 9.4 ) years and body mass index , 33.1 ( 3.8 ) . INTERVENTIONS Participants were r and omized to a basic Internet ( n = 46 ) or to an Internet plus behavioral e-counseling program ( n = 46 ) . Both groups received 1 face-to-face counseling session and the same core Internet programs and were instructed to su bmi t weekly weights . Participants in e-counseling su bmi tted calorie and exercise information and received weekly e-mail behavioral counseling and feedback from a counselor . MAIN OUTCOME MEASURES Measured weight and waist circumference at 0 and 12 months . RESULTS Intent-to-treat analyses showed the behavioral e-counseling group lost more mean ( SD ) weight at 12 months than the basic Internet group ( -4.4 [ 6.2 ] vs -2.0 [ 5.7 ] kg ; P = .04 ) , and had greater decreases in percentage of initial body weight ( 4.8 % vs 2.2 % ; P = .03 ) , body mass index ( -1.6 [ 2.2 ] vs -0.8 [ 2.1 ] ; P = .03 ) , and waist circumference ( -7.2 [ 7.5 ] vs -4.4 [ 5.7 ] cm ; P = .05 ) . CONCLUSION Adding e-mail counseling to a basic Internet weight loss intervention program significantly improved weight loss in adults at risk of diabetes BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients . METHODS A r and omized-controlled trial was conducted . Using a Solomon-four group design , 190 female patients were recruited from three US fertility centers and were r and omized into two experimental and two no-treatment control groups . The psychological outcomes assessed included infertility distress , infertility self-efficacy , decisional conflict , marital cohesion and coping style . Program dosage and satisfaction were also assessed at four weeks follow-up . RESULTS Women exposed to the online program significantly improved in the area of social concerns ( P = 0.038 ) related to infertility distress , and felt more informed about a medical decision with which they were contending ( P = 0.037 ) . Trends were observed for decreased global stress(P = 0.10 ) , sexual concerns ( P = 0.059 ) , distress related to child-free living ( P = 0.063 ) , increased infertility self-efficacy ( P = 0.067 ) and decision making clarity ( P = 0.079 ) . A dosage response was observed in the experimental groups for women who spent > 60 min online for decreased global stress ( P = 0.028 ) and increased self efficacy ( P = 0.024 ) . CONCLUSIONS This evidence -based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective re source for fertility practice OBJECTIVE To evaluate the feasibility of a web-based coaching programme for vascular risk factor treatment , to describe the patterns of use and to measure changes in risk factors . METHODS Patients with a clinical manifestation of arterial disease and Internet access were asked to participate in the nurse-led Internet-based risk factor management programme . At the first clinic visit , a personalized action plan was made for the treatment of risk factors . Patients were instructed on communication with a specialized nurse through Internet and encouraged to enter self-measured risk factor levels at their personalized website . The nurse practitioner replied on working days and gave feedback , support , and recommendations on lifestyle and medical treatment . After 6 months , risk factors were re-measured . RESULTS Fifty patients participated , 70 % were overweight , 64 % had hypertension , 42 % hyperlipidemia , and 24 % smoked at baseline . During 6 months , the log-in average at the individual website was 35 times per patient ( 1.3 log-ins/week ) ; while the nurse practitioner logged-in at the overall website 23 times/week . The website was hardly used by five patients . Most e-mail messages were sent by patients for hypertension ( 211 times ) and obesity ( 203 times ) , whereas the nurse practitioner sent nearly twice as many e-mail messages for hypertension ( 400 times ) and obesity ( 455 times ) . The level of most risk factors decreased and the fraction of achieved treatment goals increased ( blood pressure from 36 to 58 % , LDL-cholesterol from 58 to 64 % , glucose from 64 to 82 % ) . CONCLUSIONS A web-based vascular risk factor intervention programme is feasible ; it is frequently used by patients and suitable to decrease the level of several risk factors . It has the promise of being an efficacious intervention for risk factor sanitation in patients with symptomatic vascular disease . PRACTICE IMPLICATION S An Internet-based individualised risk management programme could make patients aware of their self-management capability and may contribute to risk factor reduction BACKGROUND Internet-based cognitive behaviour therapy ( CBT ) is a promising new approach for the treatment of depressive symptoms . The current study had two aims : ( 1 ) to determine whether , after 1 year , an internet-based CBT intervention was more effective than a waiting-list control group ; and ( 2 ) to determine whether the effect of the internet-based CBT differed from the group CBT intervention , 1 year after the start of treatment . METHOD A total of 191 women and 110 men ( mean age=55 years , s.d.=4.6 ) with subthreshold depression were r and omized into internet-based treatment , group CBT ( Lewinsohn 's Coping with Depression Course ) , or a waiting-list control condition . The main outcome measure was treatment response after 1 year , defined as the difference in pretreatment and follow-up scores on the Beck Depression Inventory ( BDI ) . Missing data were imputed using the multiple imputation procedure of data augmentation . Analyses were performed using multiple imputation inference . RESULTS In the waiting-list control group , we found a pretreatment to follow-up improvement effect size of 0.69 , which was 0.62 in the group CBT condition and 1.22 with the internet-based treatment condition . Simple contrasts showed a significant difference between the waiting-list condition and internet-based treatment ( p=0.03 ) and no difference between both treatment conditions ( p=0.08 ) . CONCLUSIONS People aged over 50 years with subthreshold depression can still benefit from internet-based CBT 1 year after the start of treatment A r and omized trial was conducted comparing 10 individual weekly sessions of cognitive behaviour therapy for panic disorder ( PD ) with or without agoraphobia with a 10-module self-help program on the Internet . After confirming the PD diagnosis with an in-person structured clinical interview ( SCID ) 49 participants were r and omized . Overall , the results suggest that Internet-administered self-help plus minimal therapist contact via e-mail can be equally effective as traditional individual cognitive behaviour therapy . Composite within-group effect sizes were high in both groups , while the between-group effect size was small ( Cohen 's d=16 ) . One-year follow-up confirmed the results , with a within-group effect size of Cohen 's d=0.80 for the Internet group and d=0.93 for the live group . The results from this study generally provide evidence to support the continued use and development of Internet-distributed self-help programs The objective of this study was to compare continuous positive airway pressure ( CPAP ) use , functional status , and client satisfaction in obstructive sleep apnea syndrome ( OSAS ) patients r and omized to either telemedicine support or traditional care . In our university-affiliated sleep disorders center , patients with OSAS who were initiating CPAP therapy were r and omized to receive telemedicine support vs traditional follow-up care for 30 days . The telemedicine group received a “ Health Buddy ” computer that provided daily Internet-based informational support and feedback for problems experienced with CPAP use . At 30 days , there were no significant differences in the hours of CPAP use between groups receiving traditional care ( M=4.22 , SD±2.05 ) and telemedicine support ( M=4.29 , SD±2.15 ) , p=0.87 , or in the proportion of nights with CPAP use between the traditional ( M=50%±33.8 ) and telemedicine groups ( M=47%±34.2 ) , p=0.61 . No significant differences were found between groups in functional status ( M=2.27±4.56 vs M=2.03±3.88 , respectively , p=0.76 ) or client satisfaction ( M=28.0±3.51 vs M=28.5±3.05 , p=0.43 ) . Patients in the telemedicine and traditional groups had similar CPAP use , functional status , and client satisfaction . The data suggest that telemedicine support as provided by our model compares favorably with traditional care . As a provider-extender , telemedicine support for patients initiating use of CPAP may allow for greater practice efficiency while maintaining quality of care OBJECTIVE To better underst and the mixed findings regarding the efficacy of Internet-based physical activity interventions , we examined the use and usefulness of particular website components that may lead to improvements in intervention efficacy . METHOD Participants were sedentary individuals from a 12-month r and omized controlled physical activity trial conducted in Providence , Rhode Isl and and Pittsburgh , Pennsylvania from 2003 - 2006 . The present study included participants from the Tailored Internet arm ( n=81 ; instantaneous web-based tailored feedback to participants ) or the St and ard Internet arm ( n=82 ; websites currently available to the public ) . We obtained objective data via the intervention websites and subjective usefulness data via question naires . RESULTS The Tailored Internet arm logged onto their website significantly more times than the St and ard Internet arm ( median 50 vs. 38 ; p<.05 ) . Among participants in the Tailored Internet arm , the self-monitoring feature ( i.e. , logging ) followed by goal setting were rated as the most useful website components . CONCLUSION Logins in the current study were substantially higher compared to previous studies . Participants endorsed goal setting and self-monitoring as being most useful , which are critical components for health behavior change . Future studies should continue to examine these features and improve the perceived usefulness of other theory-based strategies INTRODUCTION There are 1.1 billion smokers worldwide . Traditional smoking cessation methods , such as nicotine replacement therapy and smoking cessation groups , yield between 14 % and 27 % abstinence rates at 6 months . Evidence -based Internet interventions with comparable abstinence rates could be a powerful global tool to reduce tobacco-related morbidity and mortality . METHODS We report a r and omized control trial in which 500 Spanish-speaking and 500 English-speaking adult Internet users , smoking at least 5 cigarettes/day and intending to quit in the next month , were recruited online from 68 countries . Consenting participants who completed baseline measures , logged cigarettes smoked on 3 days within a week , and set a quit date were r and omized to four conditions . Each condition added new elements : Condition 1 was the " Guía Para Dejar de Fumar , " a static National Cancer Institute evidence -based stop smoking guide ; Condition 2 consisted of Condition 1 plus E-mail reminders to return to the site ; Condition 3 consisted of Condition 2 plus mood management lessons ; and Condition 4 consisted of Condition 3 plus a " virtual group " ( an asynchronous bulletin board ) . Main outcome measures were 7-day point prevalence abstinence at 1 , 3 , 6 , and 12 months after initial quit date . RESULTS There were no significant differences among the four conditions . The overall 12-month 7-day abstinence rates were 20.2 % for Spanish speakers and 21.0 % for English speakers when those with missing data were assumed to be smoking . DISCUSSION Internet smoking cessation interventions with such abstinence rates provided globally in additional language s could contribute substantially to tobacco control efforts Background Web-based programs for health promotion , disease prevention , and disease management often experience high rates of attrition . There are 3 questions which are particularly relevant to this issue . First , does engagement with program content predict long-term outcomes ? Second , which users are most likely to drop out or disengage from the program ? Third , do particular intervention strategies enhance engagement ? Objective To determine : ( 1 ) whether engagement ( defined by the number of Web sections opened ) in a Web-based smoking cessation intervention predicts 6-month abstinence , ( 2 ) whether particular sociodemographic and psychographic groups are more likely to have lower engagement , and ( 3 ) whether particular components of a Web-based smoking cessation program influence engagement . Methods A r and omized trial of 1866 smokers was used to examine the efficacy of 5 different treatment components of a Web-based smoking cessation intervention . The components were : high- versus low-personalized message source , high- versus low-tailored outcome expectation , efficacy expectation , and success story messages . Moreover , the timing of exposure to these sections was manipulated , with participants r and omized to either a single unified Web program with all sections available at once , or sequential exposure to each section over a 5-week period of time . Participants from 2 large health plans enrolled to receive the online behavioral smoking cessation program and a free course of nicotine replacement therapy ( patch ) . The program included : an introduction section , a section focusing on outcome expectations , 2 sections focusing on efficacy expectations , and a section with a narrative success story ( 5 sections altogether , each with multiple screens ) . Most of the analyses were conducted with a stratification of the 2 exposure types . Measures included : sociodemographic and psychosocial characteristics , Web sections opened , perceived message relevance , and smoking cessation 6-months following quit date . Results The total number of Web sections opened was related to subsequent smoking cessation . Participants who were younger , were male , or had less formal education were more likely to disengage from the Web-based cessation program , particularly when the program sections were delivered sequentially over time . More personalized source and high-depth tailored self-efficacy components were related to a greater number of Web sections opened . A path analysis model suggested that the impact of high-depth message tailoring on engagement in the sequentially delivered Web program was mediated by perceived message relevance . Conclusions Results of this study suggest that one of the mechanisms underlying the impact of Web-based smoking cessation interventions is engagement with the program . The source of the message , the degree of message tailoring , and the timing of exposure appear to influence Web-based program engagement This study evaluated a synchronous Internet-delivered intervention ( chat room ) for improving eating habits and body image in college-age women at risk for developing an eating disorder . Sixty at-risk women ( mean age = 18.9 , SD = 2.4 ; 65.0 % Caucasian , 19 % Latino/Hispanic , 8 % Asian/Pacific Isl and er , 3 % African American , 5 % other ; mean body mass index = 25.6 , SD = 5.7 ) were r and omly assigned to intervention ( n = 30 ) or control ( n = 30 ) groups . Once a week for 8 weeks , participants used a private chat room for a 1-hr moderated discussion focused on improving body image and eating behaviors . Additional treatment components included psychoeducation , asynchronous support , homework , and summaries . Assessment s were conducted at baseline , posttreatment , and 10 weeks after posttreatment . Participants indicated high satisfaction with the intervention mode . Intervention participants significantly reduced eating pathology and improved self-esteem over controls at follow-up . These findings suggest that synchronous , Internet-delivered programs are efficacious and have potential to reduce problematic attitudes and behaviors that may lead to eating disorders among college-age women OBJECTIVES We assessed change in fruit and vegetable intake in a population -based sample , comparing an online untailored program ( arm 1 ) with a tailored behavioral intervention ( arm 2 ) and with a tailored behavioral intervention plus motivational interviewing-based counseling via e-mail ( arm 3 ) . METHODS We conducted a r and omized controlled intervention trial , enrolling members aged 21 to 65 years from 5 health plans in Seattle , Washington ; Denver , Colorado ; Minneapolis , Minnesota ; Detroit , Michigan ; and Atlanta , Georgia . Participants reported fruit and vegetable intake at baseline and at 3 , 6 , and 12 months . We assessed mean change in fruit and vegetable servings per day at 12 months after baseline , using a vali date d self-report fruit and vegetable food frequency question naire . RESULTS Of 2540 trial participants , 80 % were followed up at 12 months . Overall baseline mean fruit and vegetable intake was 4.4 servings per day . Average servings increased by more than 2 servings across all study arms ( P<.001 ) , with the greatest increase ( + 2.8 servings ) among participants of arm 3 ( P=.05 , compared with control ) . Overall program satisfaction was high . CONCLUSIONS This online nutritional intervention was well received , convenient , easy to disseminate , and associated with sustained dietary change . Such programs have promise as population -based dietary interventions BACKGROUND Initial trials of web-based smoking-cessation programs have generally been promising . The active components of these programs , however , are not well understood . This study aim ed to ( 1 ) identify active psychosocial and communication components of a web-based smoking-cessation intervention and ( 2 ) examine the impact of increasing the tailoring depth on smoking cessation . DESIGN R and omized fractional factorial design . SETTING Two HMOs : Group Health in Washington State and Henry Ford Health System in Michigan . PARTICIPANTS 1866 smokers . INTERVENTION A web-based smoking-cessation program plus nicotine patch . Five components of the intervention were r and omized using a fractional factorial design : high- versus low-depth tailored success story , outcome expectation , and efficacy expectation messages ; high- versus low-personalized source ; and multiple versus single exposure to the intervention components . MEASUREMENTS Primary outcome was 7 day point-prevalence abstinence at the 6-month follow-up . FINDINGS Abstinence was most influenced by high-depth tailored success stories and a high-personalized message source . The cumulative assignment of the three tailoring depth factors also result ed in increasing the rates of 6-month cessation , demonstrating an effect of tailoring depth . CONCLUSIONS The study identified relevant components of smoking-cessation interventions that should be generalizable to other cessation interventions . The study also demonstrated the importance of higher-depth tailoring in smoking-cessation programs . Finally , the use of a novel fractional factorial design allowed efficient examination of the study aims . The rapidly changing interfaces , software , and capabilities of eHealth are likely to require such dynamic experimental approaches to intervention discovery This pilot study examined the acceptability and feasibility of conducting a weight loss maintenance intervention over the Internet . Obese adults participated in a 15-week behavioral weight control intervention and were then r and omly assigned to one of the following three maintenance conditions : ( a ) in-person , therapist-led ( TL ) ; ( b ) Internet , therapist-led ( I ) ; and ( c ) control ( C ) . Both maintenance interventions met biweekly for 22 weeks using the same program content . Results showed that TL participants were more likely to attend their meetings and feel more satisfied with their group assignment . Ho wever , there were no differences between the TL and I groups in overall attrition or number of peer support contacts made . There was also no significant difference in weight loss between the groups . Thus , the Internet may hold promise as a method for maintaining contact with patients to facilitate long-term behavior change Computer-based delivery of health-related psychoeducational programming is increasingly popular . In the present study , 72 non-symptomatic undergraduate women were r and omized to an Internet-based prevention program for eating disorders with or without accompanying discussion groups , or a control group . Sixty-one of the women ( 84 % ) completed the Student Bodies program , and were assessed at short and eight – nine month follow-up . Participation in the program result ed in better outcomes across all groups compared to controls , and women in the unmoderated discussion group appeared to have the most reduction in risk . Benefits of the program continued at follow-up . Decrease in risk also was associated with time spent using the Internet-based program . The present study suggests that the use of Student Bodies may reduce risk of eating and body image concerns over the long term , and that moderation of discussion groups may not be essential for successful outcomes . Further research on larger sample s will help determine the degree to which discussion groups or the Student Bodies program alone are effective In a prospect i ve study , 23 proximal interphalangeal joints that were severely contracted ( > or = 45 degrees ) as a result of Dupuytren 's disease underwent operative correction and 6 months of dynamic extension splinting . Proximal interphalangeal joint extension was measured preoperatively and postoperatively at 3-month intervals for 1 year and at 6-month intervals thereafter . Mean follow-up was 2 years ( minimum , 1 year ) . Overall , at 2 years , 44 % improvement in proximal interphalangeal joint extension was noted . Mean improvement of 59 % in proximal interphalangeal joint extension was noted in patients who complied with the postoperative dynamic extension splinting program . Patients who were noncomplaint demonstrated a 25 % improvement in proximal interphalangeal joint extension . The difference in values between patients who were compliant and those who were not was statistically significant . Other factors -- severity of contracture , digit involved , and the necessity for capsular release -- were not significantly related to outcome . This study suggests that soft tissue responds to continuous dynamic extension stresses and can be remodeled over time OBJECTIVE The authors extend previous research on homework in psychotherapy by examining the relationship between homework compliance and therapeutic outcome among depressed older adult out patients ( N = 63 ) , addressing previous limitations by using session-by-session therapist ratings of homework compliance and including both interviewer ratings and patient self-reports of outcomes . METHODS Patients were participants in a r and omized clinical trial evaluating the efficacy of desipramine versus cognitive/behavioral therapy-alone ( C/B-Alone ) versus a combination of the two ( Combined ) . Given the current study 's focus on homework compliance , only patients assigned to conditions with assigned homework in the clinical trial ( i.e. , C/B-Alone and Combined conditions ) were included . RESULTS Results of hierarchical regression analyses indicated that homework compliance contributed significantly to posttreatment outcome as measured by both interviewer-administered and patient self-report measures of depression . A separate series of ANOVAs also found significant differences in pre-posttreatment change between patients scoring above and below the median of reported homework compliance . Findings were similar for patients in the C/B-Alone and Combined conditions . CONCLUSION The study 's results call for additional research on issues related to homework compliance with older adult patients Objective : In a r and omized controlled trial Titov et al. ( 2008 ) demonstrated significant benefit from an Internet- and email-based treatment programme for social phobia . The present study ( Shyness 2 ) seeks to replicate that finding and compares results with benchmark data . Method : Eighty-eight individuals with social phobia were r and omly assigned to a clinician-assisted computerized cognitive behavioural treatment programme or to a waitlist control group . Participants completed the same treatment programme used in Shyness 1 , consisting of six online lessons , cognitive behavioural homework assignments , email contact with a therapist , and participation in an online discussion forum . An intention-to-treat model was used for data analyses . Results : A total of 80 % of treatment group participants completed all lessons , and post-treatment data were obtained from 78/81 participants . Treatment group participants each had an average of 127 min of therapist contact over the 10 week programme , including an average of 22 email contacts plus therapist responses to forum postings . Pre- to post-treatment differences were seen between treatment and waitlist participants across two measures of symptoms of social phobia , and across a measure of disability . Mean within- and between-group effect sizes ( Cohen 's d ) across the two primary outcome measures were 1.18 , and 1.20 , respectively . Quantitative and qualitative data indicate that the procedure is very acceptable to participants . Conclusions : These results closely replicate those obtained in Shyness 1 , indicating that the treatment procedure is reliable . These results compare favourably with outcomes reported in benchmarking studies from high- quality face-to-face treatment programmes for social phobia . These results provide further positive data about the utility of Internet-based guided self-help programmes for people with social phobia BACKGROUND This study investigated the efficacy of an Internet-based self-help program with minimal therapist contact via e-mail for Swedish university students with social phobia and public speaking fears . The main objective was to test if the Internet-based self-help program would be more effective if five live group exposure sessions were added . METHODS Thirty-eight students meeting the diagnostic and statistical manual of mental disorders , 4th edition criteria for social phobia were r and omized into two different treatment groups : Internet delivered cognitive behavior therapy combined with five group exposure sessions ( ICBT+ exp ) or the Internet program alone ( ICBT ) . RESULTS Results were analyzed on an intention-to-treat basis . Both treatment groups showed significant improvement from pre- to post-test , and from pre-test to 1-year follow-up , on all measured dimensions ( social anxiety , general anxiety , depression levels , and quality of life ) . For both the groups , the average within-group effect sizes for the primary social anxiety scales , expressed as Cohen 's d , were comparable to those seen in traditionally administered cognitive behavioral therapy both at post-test and at 1- year follow-up . CONCLUSIONS The results suggest that the Internet-based self-help program on its own is efficient in the treatment of university students with social phobia . Adding group exposure sessions did not improve the outcome significantly Background Internet programs for smoking cessation are widely available but few controlled studies demonstrate long-term efficacy . Purpose To determine the 13-month effectiveness of an Internet program presenting a set sequence of interactive steps , and the role of depressed affect . Methods In a r and omized controlled trial sponsored by the American Cancer Society , a treatment condition ( n = 1,106 ) was compared to a control site ( n = 1,047 ) . Results More treatment condition participants were abstinent ( 30-day point prevalence ) than control site participants ( 12.9 % vs. 10.1 % , p < .05 ) at 13 months . This effect was greater among participants not reporting depressed affect ( 15.0 % vs. 10.1 % , p < .01 ) . Among smokers who reported depressed affect , there was no difference in abstinence between the treatment and control conditions . Conclusions Data support the long-term efficacy of an Internet intervention for cessation modeled on a structured , in-person treatment approach , especially for participants not experiencing daily depressed affect |
1,315 | 25,736,235 | Conclusions and Implication s of Key Findings This study provides the first systematic evaluation of DPP-4 inhibitors for patients with type 2 diabetes .
It found that , in patients with type 2 diabetes who do not achieve glycemic targets with antidiabetic monotherapy , DPP-4 inhibitors as add-on treatment may represent a cost-effective option compared with sulfonylureas and insulin . | Background Dipeptidyl peptidase-4 ( DPP-4 ) inhibitors are a new class of antidiabetic drugs used for treating type 2 diabetes mellitus .
While many studies have reported on the cost-effectiveness of DPP-4 inhibitors for treating type 2 diabetes , a systematic review of economic evaluations of DPP-4 inhibitors is currently lacking .
Objectives The aim of this systematic review was to assess the cost effectiveness of DPP-4 inhibitors for patients with type 2 diabetes . | Aims : Assess the efficacy and safety of saxagliptin added to a submaximal sulphonylurea dose vs. uptitration of sulphonylurea monotherapy in patients with type 2 diabetes and inadequate glycaemic control with sulphonylurea monotherapy . Methods and patients : A total of 768 patients ( 18–77 years ; HbA1c screening ≥ 7.5 to ≤ 10.0 % ) were r and omised and treated with saxagliptin 2.5 or 5 mg in combination with glyburide 7.5 mg vs. glyburide 10 mg for 24 weeks . Blinded uptitration glyburide was allowed in the glyburide-only arm to a maximum total daily dose of 15 mg . Efficacy analyses were performed using ANCOVA and last-observation-carried-forward methodology . Results : At week 24 , 92 % of glyburide-only patients were uptitrated to a total glyburide dose of 15 mg/day . Saxagliptin 2.5 and 5 mg provided statistically significant adjusted mean decreases from baseline to week 24 vs. uptitrated glyburide , respectively , in HbA1c ( −0.54 % , −0.64 % vs. + 0.08 % ; both p < 0.0001 ) and fasting plasma glucose ( −7 , −10 vs. + 1 mg/dl ; p = 0.0218 and p = 0.002 ) . The proportion of patients achieving an HbA1c < 7 % was greater for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide ( 22.4 % and 22.8 % vs. 9.1 % ; both p < 0.0001 ) . Postpr and ial glucose area under the curve was reduced for saxagliptin 2.5 and 5 mg vs. uptitrated glyburide ( −4296 and −5000 vs. + 1196 mg·min/dl ; both p < 0.0001 ) . Adverse event occurrence was similar across all groups . Reported hypoglycaemic events were not statistically significantly different for saxagliptin 2.5 ( 13.3 % ) and 5 mg ( 14.6 % ) vs. uptitrated glyburide ( 10.1 % ) . Conclusion : Saxagliptin added to submaximal glyburide therapy led to statistically significant improvements vs. uptitration of glyburide alone across key glycaemic parameters and was generally well tolerated Abstract Background : The lack of adequate glycaemic control for patients with type 2 diabetes mellitus ( T2DM ) , especially with existing second-line therapies , represents an unmet medical need . Of the newer therapies , the incretin-based medicines , such as saxagliptin , look promising to consoli date second-line pharmacotherapy . Objective : This study evaluates the long-term economic consequences of saxagliptin versus sulfonylurea ( glipizide ) as second-line therapy when used in combination with metformin after failure of monotherapy treatment with metformin , in patients with T2DM in Germany . Methods : A published discrete event simulation model with a fixed-time increment was used to model the effects of different treatment scenarios over a 40-year ( life- ) time horizon . Disease progression was modelled using evidence from the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) 68 . The treatment sequence matched that of published German guidelines , and efficacy and safety data were derived from published sources . The model assumes that quality -adjusted life-years ( QALYs ) are affected by complications , hypoglycaemic events and weight change over a lifetime . Costs were specific to the German setting , where sulfonylureas are generic . Costs and effects were discounted annually at 3 % . The extended perspective of the national sick funds was adopted , and recommendations from the Institute for Quality and Efficiency in Health Care ( IQWiG ) were considered . Results : In the base-case analysis , treatment with saxagliptin plus metformin was associated with a lower incidence of both symptomatic and severe hypoglycaemic events , result ing in an incremental benefit of 0.12 QALYs and an incremental cost-effectiveness ratio ( ICER ) of € 13 931 per QALY gained compared with sulfonylurea plus metformin ( year of costing 2009 ) . Modest reductions in all macro- and microvascular complications were seen in those receiving saxagliptin plus metformin compared with sulfonylurea plus metformin . Sensitivity analysis showed that treatment-related weight changes , as a risk factor for complications , represent the most influential driver of cost effectiveness . Conclusion : The study demonstrated improved outcomes with saxagliptin at a cost that would likely be considered acceptable in the German setting . Furthermore , the findings of the sensitivity analysis suggest that the results are robust to various assumptions concerning input variables and modelling assumptions AIM To assess the efficacy and safety of a 24-week treatment with sitagliptin , a highly selective once-daily oral dipeptidyl peptidase-4 ( DPP-4 ) inhibitor , in patients with type 2 diabetes who had inadequate glycaemic control [ glycosylated haemoglobin ( HbA(1c ) ) > or=7.5 % and < or=10.5 % ] while on glimepiride alone or in combination with metformin . METHODS After a screening , diet/exercise run-in and drug wash-off period , a glimepiride + /- metformin dose titration/stabilization period and a 2-week , single-blind placebo run-in , 441 patients ( of ages 18 - 75 years ) were r and omized to receive the addition of sitagliptin 100 mg once daily or placebo in a 1 : 1 ratio for 24 weeks . Of these patients , 212 were on glimepiride ( > or=4 mg/day ) monotherapy and 229 were on glimepiride ( > or=4 mg/day ) plus metformin ( > or=1,500 mg/day ) combination therapy . Patients exceeding pre-specified glycaemic thresholds during the double-blind treatment period were provided open-label rescue therapy ( pioglitazone ) until study end . The primary efficacy analysis evaluated the change in HbA(1c ) from baseline to Week 24 . Secondary efficacy endpoints included fasting plasma glucose ( FPG ) , 2-h post-meal glucose and lipid measurements . RESULTS Mean baseline HbA(1c ) was 8.34 % in the sitagliptin and placebo groups . After 24 weeks , sitagliptin reduced HbA(1c ) by 0.74 % ( p < 0.001 ) relative to placebo . In the subset of patients on glimepiride plus metformin , sitagliptin reduced HbA(1c ) by 0.89 % relative to placebo , compared with a reduction of 0.57 % in the subset of patients on glimepiride alone . The addition of sitagliptin reduced FPG by 20.1 mg/dl ( p < 0.001 ) and increased homeostasis model assessment -beta , a marker of beta-cell function , by 12 % ( p < 0.05 ) relative to placebo . In patients who underwent a meal tolerance test ( n = 134 ) , sitagliptin decreased 2-h post-pr and ial glucose ( PPG ) by 36.1 mg/dl ( p < 0.001 ) relative to placebo . The addition of sitagliptin was generally well tolerated , although there was a higher incidence of overall ( 60 vs. 47 % ) and drug-related adverse experiences ( AEs ) ( 15 vs. 7 % ) in the sitagliptin group than in the placebo group . This was largely because of a higher incidence of hypoglycaemia AEs ( 12 vs. 2 % , respectively ) in the sitagliptin group compared with the placebo group . Body weight modestly increased with sitagliptin relative to placebo ( + 0.8 vs. -0.4 kg ; p < 0.001 ) . CONCLUSIONS Sitagliptin 100 mg once daily significantly improved glycaemic control and beta-cell function in patients with type 2 diabetes who had inadequate glycaemic control with glimepiride or glimepiride plus metformin therapy . The addition of sitagliptin was generally well tolerated , with a modest increase in hypoglycaemia and body weight , consistent with glimepiride therapy and the observed degree of glycaemic improvement AIM To assess the efficacy and safety of saxagliptin vs. glipizide as add-on therapy to metformin in patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone . METHODS AND PATIENTS A total of 858 patients [ age ≥ 18 years ; glycated haemoglobin ( HbA(1c ) ) > 6.5 - 10.0 % ; on stable metformin doses ≥ 1500 mg/day ] were r and omised 1 : 1 to saxagliptin 5 mg/day or glipizide up-titrated as needed from 5 to 20 mg/day for 52 weeks . The primary objective was to assess if the change from baseline HbA(1c ) achieved with saxagliptin plus metformin was non-inferior to glipizide plus metformin . RESULTS The per- protocol analysis demonstrated non-inferiority of saxagliptin vs. glipizide ; adjusted mean changes from baseline HbA(1c ) were -0.74 % vs. -0.80 % , respectively ; the between-group difference was 0.06 % ( 95 % CI , -0.05 % to 0.16 % ) . Treatment with saxagliptin vs. glipizide was associated with a significantly smaller proportion of patients with hypoglycaemic events ( 3.0 % vs. 36.3 % ; p < 0.0001 ) and a divergent impact on body weight ( adjusted mean change from baseline -1.1 kg with saxagliptin vs. 1.1 kg with glipizide ; p < 0.0001 ) . There was a significantly smaller rise in HbA(1c ) ( % /week ) from week 24 to 52 with saxagliptin vs. glipizide ( 0.001 % vs. 0.004 % ; p = 0.04 ) indicating a sustained glycaemic effect beyond week 24 . Excluding hypoglycaemic events , the proportion of patients experiencing adverse events ( AEs ) was similar ( 60.0 % saxagliptin vs. 56.7 % glipizide ) ; treatment-related AEs were less common with saxagliptin vs. glipizide ( 9.8 % vs. 31.2 % ) , attributable to the higher frequency of hypoglycaemia in glipizide patients . Discontinuation rates result ing from AEs were similar ( ∼4 % ) . CONCLUSION Saxagliptin plus metformin was well tolerated , provided a sustained HbA(1c ) reduction over 52 weeks , and was non-inferior to glipizide plus metformin , with reduced body weight and a significantly lower risk of hypoglycaemia BACKGROUND Severe hypoglycemia may increase the risk of a poor outcome in patients with type 2 diabetes assigned to an intensive glucose-lowering intervention . We analyzed data from a large study of intensive glucose lowering to explore the relationship between severe hypoglycemia and adverse clinical outcomes . METHODS We examined the associations between severe hypoglycemia and the risks of macrovascular or microvascular events and death among 11,140 patients with type 2 diabetes , using Cox proportional-hazards models with adjustment for covariates measured at baseline and after r and omization . RESULTS During a median follow-up period of 5 years , 231 patients ( 2.1 % ) had at least one severe hypoglycemic episode ; 150 had been assigned to intensive glucose control ( 2.7 % of the 5571 patients in that group ) , and 81 had been assigned to st and ard glucose control ( 1.5 % of the 5569 patients in that group ) . The median times from the onset of severe hypoglycemia to the first major macrovascular event , the first major microvascular event , and death were 1.56 years ( interquartile range , 0.84 to 2.41 ) , 0.99 years ( interquartile range , 0.40 to 2.17 ) , and 1.05 years ( interquartile range , 0.34 to 2.41 ) , respectively . During follow-up , severe hypoglycemia was associated with a significant increase in the adjusted risks of major macrovascular events ( hazard ratio , 2.88 ; 95 % confidence interval [ CI ] , 2.01 to 4.12 ) , major microvascular events ( hazard ratio , 1.81 ; 95 % CI , 1.19 to 2.74 ) , death from a cardiovascular cause ( hazard ratio , 2.68 ; 95 % CI , 1.72 to 4.19 ) , and death from any cause ( hazard ratio , 2.69 ; 95 % CI , 1.97 to 3.67 ) ( P<0.001 for all comparisons ) . Similar associations were apparent for a range of nonvascular outcomes , including respiratory , digestive , and skin conditions ( P<0.01 for all comparisons ) . No relationship was found between repeated episodes of severe hypoglycemia and vascular outcomes or death . CONCLUSIONS Severe hypoglycemia was strongly associated with increased risks of a range of adverse clinical outcomes . It is possible that severe hypoglycemia contributes to adverse outcomes , but these analyses indicate that hypoglycemia is just as likely to be a marker of vulnerability to such events . ( Funded by Servier and the National Health and Medical Research Council of Australia ; Clinical Trials.gov number , NCT00145925 . ) OBJECTIVE This 24-week trial assessed the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes with inadequate glycemic control with metformin alone . RESEARCH DESIGN AND METHODS This was a r and omized , double-blind , placebo-controlled study of saxagliptin ( 2.5 , 5 , or 10 mg once daily ) or placebo plus a stable dose of metformin ( 1,500–2,500 mg ) in 743 patients ( A1C ≥7.0 and ≤10.0 % ) . Efficacy analyses were performed using an ANCOVA model using last observation carried forward methodology on primary ( A1C ) and secondary ( fasting plasma glucose [ FPG ] and postpr and ial glucose [ PPG ] area under the curve [ AUC ] ) end points . RESULTS Saxagliptin ( 2.5 , 5 , and 10 mg ) plus metformin demonstrated statistically significant adjusted mean decreases from baseline to week 24 versus placebo in A1C ( −0.59 , −0.69 , and −0.58 vs. + 0.13 % ; all P < 0.0001 ) , FPG ( −14.31 , −22.03 , and −20.50 vs. + 1.24 mg/dl ; all P < 0.0001 ) , and PPG AUC ( −8,891 , −9,586 , and −8,137 vs. −3,291 mg · min/dl ; all P < 0.0001 ) . More than twice as many patients achieved A1C < 7.0 % with 2.5 , 5 , and 10 mg saxagliptin versus placebo ( 37 , 44 , and 44 vs. 17 % ; all P < 0.0001 ) . β-Cell function and postpr and ial C-peptide , insulin , and glucagon AUCs improved in all saxagliptin treatment groups at week 24 . Incidence of hypoglycemic adverse events and weight reductions were similar to those with placebo . CONCLUSIONS Saxagliptin once daily added to metformin therapy was generally well tolerated and led to statistically significant improvements in glycemic indexes versus placebo added to metformin in patients with type 2 diabetes inadequately controlled with metformin alone OBJECTIVES To estimate the cost-effectiveness of etanercept ( ETN ) plus usual care ( including NSAIDs ) compared with usual care alone ( including NSAIDs ) in patients with severe AS in Germany . METHODS A mathematical model previously applied to the UK was adapted using re source use and cost data ( for 2007 ) from the national data base of the German Collaborative Arthritis Centres . Social health insurance ( SHI ) and societal perspectives were analysed . Assumptions on initial response and changes in health-related quality of life were based on Phase III r and omized controlled trials . Initial treatment response according to British Society for Rheumatology guidelines were assumed as a conservative estimate in the German context . Long-term disease progression was based on the available literature . Incremental cost-effectiveness ratios ( ICERs ) were expressed as euros/ quality -adjusted life year ( QALY ) , for a cohort of 1000 patients over 25 years . Sensitivity analyses explored uncertainty in results . RESULTS In the base case , ETN plus usual care ( including NSAIDs ) yielded 1475 more QALYs at an additional cost of € 80,827,668 ( SHI ) or € 32,657,590 ( societal ) leading to an ICER of € 54,815/QALY and € 22,147/QALY , respectively . Over a shorter time horizon of 10 years , the ICERs were € 59,006 and € 29,815 for SHI and societal viewpoints , respectively . Assumptions having the largest impact on results included withdrawal rates from ETN , quality of life , disease costs and initial response . CONCLUSIONS Cost-effectiveness for ETN in patients with severe AS in Germany differs according to the cost perspective . Study estimates were higher than in the UK but comparable with reported cost-effectiveness of anti-TNF treatments in patients with RA in Germany CONTEXT As diabetes is in part an inflammatory condition , the initiation of insulin and /or metformin may beneficially reduce levels of inflammatory biomarkers such as high-sensitivity C-reactive protein ( hsCRP ) . OBJECTIVE To determine whether insulin alone or combined with metformin lowers levels of hsCRP , IL-6 , and soluble tumor necrosis factor receptor 2 ( sTNFr2 ) in patients with recent-onset type 2 diabetes mellitus . DESIGN , SETTING , AND PARTICIPANTS R and omized 2 x 2 factorial trial of open-label insulin glargine and placebo-controlled metformin in 500 adults with type 2 diabetes ( median time from diagnosis , 2.0 years ) , suboptimal glycemic control , and elevated hsCRP levels . Patients were recruited from US office-based practice s between October 2006 and December 2008 . INTERVENTION R and om allocation to 1 of 4 treatments ( placebo metformin only , placebo metformin and insulin glargine , active metformin only , or active metformin and insulin glargine ) with dose titration targeting fasting blood glucose less than 110 mg/dL. MAIN OUTCOME MEASURES Change in hsCRP level ( primary end point ) and change in IL-6 and sTNFr2 levels ( secondary end points ) from baseline to 14 weeks . RESULTS Levels of glucose and glycated hemoglobin ( HbA(1c ) ) were significantly reduced with active treatment vs placebo ( all P values < .001 ) . Levels of hsCRP were reduced in all 4 groups . There was no significant difference in hsCRP reduction among those allocated to insulin ( -11.8 % ; 95 % CI , -18.7 % to -4.4 % ) or to no insulin ( -17.5 % ; 95 % CI , -23.9 % to -10.5 % ) ( P for difference = .25 ) , or among those allocated to active metformin ( -18.1 % ; 95 % CI , -24.4 % to -11.1 % ) or placebo metformin ( -11.2 % ; 95 % CI , -18.1 % to -3.7 % ) ( P for difference = .17 ) . In the individual treatment groups , despite a differential impact on glucose control , reductions in hsCRP in the metformin ( -16.1 % ; 95 % CI , -25.1 % to -6.1 % ) and metformin plus insulin ( -20.1 % ; 95 % CI , -28.8 % to -10.4 % ) groups were no different than reductions with placebo alone ( -19.0 % ; 95 % CI , -27.8 % to -9.1 % ; P = .67 and .87 vs placebo , respectively ) . By contrast , hsCRP reduction was attenuated with insulin alone ( -2.9 % , 95 % CI , -13.2 % to 8.6 % ; P = .03 vs placebo ) . Similar findings were noted for levels of IL-6 and sTNFr2 . CONCLUSION In patients with recent-onset type 2 diabetes , treatment with insulin or metformin compared with placebo did not reduce inflammatory biomarker levels despite improving glucose control . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00366301 AIM To compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [ haemoglobin A(1c ) ( HbA(1c ) ) > or = 6.5 and < or = 10 % ] on metformin monotherapy . METHODS After a metformin dose titration/stabilization period ( > or = 1500 mg/day ) , 1172 patients were r and omized to the addition of sitagliptin 100 mg q.d . ( N = 588 ) or glipizide 5 mg/day ( uptitrated to a potential maximum 20 mg/day ) ( N = 584 ) for 52 weeks . The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA(1c ) changes from baseline at Week 52 using a per- protocol approach . RESULTS From a mean baseline of 7.5 % , HbA(1c ) changes from baseline were -0.67 % at Week 52 in both groups , confirming non-inferiority . The proportions achieving an HbA(1c ) < 7 % were 63 % ( sitagliptin ) and 59 % ( glipizide ) . Fasting plasma glucose changes from baseline were -0.56 mmol/l ( -10.0 mg/dl ) and -0.42 mmol/l ( -7.5 mg/dl ) for sitagliptin and glipizide , respectively . The proportion of patients experiencing hypoglycaemia episodes was significantly ( p < 0.001 ) higher with glipizide ( 32 % ) than with sitagliptin ( 5 % ) , with 657 events in glipizide-treated patients compared with 50 events in sitagliptin-treated patients . Sitagliptin led to weight loss ( change from baseline = -1.5 kg ) compared with weight gain ( + 1.1 kg ) with glipizide [ between-treatment difference ( 95 % confidence interval ) = -2.5 kg ( -3.1 , -2.0 ) ; p < 0.001 ] . CONCLUSIONS In this study , the addition of sitagliptin compared with glipizide provided similar HbA(1c)-lowering efficacy over 52 weeks in patients on ongoing metformin therapy . Sitagliptin was generally well tolerated , with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide AIM To evaluate the effect of gender on clinical outcomes in people with type 2 diabetes mellitus ( T2DM ) receiving antidiabetes therapy . METHODS This is a pooled analysis from nine similarly design ed phase 3 and 4 r and omized , controlled studies evaluating insulin glargine and an active comparator ( NPH insulin , insulin lispro , premixed insulin , oral antidiabetes drugs , dietary intervention ) in adults with T2DM . Impact of gender on outcomes including HbA1c , fasting plasma glucose ( FPG ) , weight-adjusted insulin dose , and hypoglycemia incidence was evaluated after 24 weeks of treatment . RESULTS Overall , 1651 male and 1287 female individuals were included ; 49.8 % and 50.2 % were treated with insulin glargine or comparators , respectively . Females receiving insulin glargine were less likely than males to achieve a glycemic target of HbA1c≤7.0 % ( 53mmol/mol ) ( 54.3 % vs 60.8 % , respectively , p=0.0162 ) ; there was no difference between females and males receiving comparators ( 52.7 % vs 51.3 % , respectively , p=0.4625 ) . Females had significantly greater reductions in FPG ( 3.1mg/dL , p=0.0458 ) , required significantly higher insulin doses ( 0.03IU/kg , p=0.0071 ) , and had significantly higher annual rates of symptomatic ( p<0.0001 ) , glucose-confirmed ( < 50 and < 70mg/dL ) symptomatic ( p=0.0005 and p<0.0001 ) , and severe hypoglycemia ( p=0.0020 ) than males . CONCLUSIONS Females in this analysis had smaller reductions in HbA1c and were less likely to reach glycemic goals despite higher insulin doses and more hypoglycemic events than males . Differences in gender responses to therapy should be considered when individualizing treatment for people with T2DM AIM To assess the addition of sitagliptin to ongoing metformin therapy in patients with type 2 diabetes who were inadequately controlled [ haemoglobin A(1c ) ( HbA(1c ) ) 7 - 11 % ] on metformin monotherapy . METHODS Patients ( n = 273 ) on metformin ( > /=1500 mg/day ) were r and omized to receive the addition of once-daily placebo , sitagliptin 100 mg or rosiglitazone 8 mg in a 1 : 1 : 1 ratio for 18 weeks . The efficacy analysis was based on the all- patients -treated population using an analysis of co-variance with change in HbA(1c ) from baseline as the primary endpoint . RESULTS The mean baseline HbA(1c ) was 7.7 % for the entire cohort . After 18 weeks , both active add-on therapies led to greater improvements in HbA(1c ) from baseline : -0.73 % for sitagliptin ( p < 0.001 vs. placebo ) and -0.79 % for rosiglitazone compared with -0.22 % for placebo . No difference was observed between the sitagliptin and rosiglitazone treatments ( 0.06 % [ 95 % confidence interval ( CI ) : -0.14 to 0.25 ] ) . The proportion of patients achieving an HbA(1c ) < 7 % was greater with sitagliptin ( 55 % ) and rosiglitazone ( 63 % ) compared with placebo ( 38 % ) . Body weight increased from baseline with rosiglitazone ( 1.5 kg ) compared with body weight reduction with sitagliptin ( -0.4 kg ) and placebo ( -0.8 kg ) . The difference in body weight between the sitagliptin and rosiglitazone groups was 1.9 kg ( 95 % CI : 1.3 - 2.5 ) . In a prespecified analysis , the proportion of patients experiencing a greater than 3-kg increase in body weight was 21 % in the rosiglitazone group compared with 2 % in both the sitagliptin and placebo groups . Both active treatments were generally well tolerated , with no increased risk of hypoglycaemia or gastrointestinal adverse events compared with placebo . CONCLUSIONS In this 18-week study , the addition of sitagliptin was effective and well tolerated in patients with type 2 diabetes inadequately controlled with metformin monotherapy . Treatment with sitagliptin produced similar reductions in HbA(1c ) compared with the addition of rosiglitazone |
1,316 | 25,968,009 | These data underscore the clinical effect of rTMS in the treatment of tinnitus . | Abstract In this study , we conducted a systematic literature review and meta- analysis on the effect of repetitive transcranial magnetic stimulation ( rTMS ) compared with sham in chronic tinnitus patients . | This paper reports the results of a study to determine whether pulsed electromagnetic stimulation , applied over the mastoid bone , caused an improvement in the level of tinnitus in long-st and ing tinnitus sufferers . Fifty-eight patients from the Liverpool Tinnitus Association volunteered to take part in a double-blind placebo controlled trial . Active and placebo devices were r and omly allocated to these patients on their first visit . At the end of one week of treatment , each patient noted whether their tinnitus had completely disappeared , was improved , unchanged or made worse by the treatment Forty-five per cent of the patients who completed the trial were improved by the active device , but only 9 % by placebo ( P = 0.0013 , Mann-Whitney test ) . We suggest that electromagnetic stimulation may be an effective treatment in some tinnitus sufferers Background Tinnitus , the perception of sound and noise in absence of an auditory stimulus , has been shown to be associated with maladaptive neuronal reorganization and increased activity of the temporoparietal cortex . Transient modulation of tinnitus by repetitive transcranial magnetic stimulation ( rTMS ) indicated that these areas are critically involved in the pathophysiology of tinnitus and suggested new treatment strategies . However , the therapeutic efficacy of rTMS in tinnitus is still unclear , individual response is variable , and the optimal stimulation area disputable . Recently , continuous theta burst stimulation ( cTBS ) has been put forward as an effective rTMS protocol for the reduction of pathologically enhanced cortical excitability . Methods 48 patients with chronic subjective tinnitus will be included in this r and omized , placebo controlled , three-arm trial . The treatment consists of two trains of cTBS applied bilaterally to the secondary auditory cortex , the temporoparietal associaction cortex , or to the lower occiput ( sham condition ) every working day for four weeks . Primary outcome measure is the change of tinnitus distress as quantified by the Tinnitus Question naire ( TQ ) . Secondary outcome measures are tinnitus loudness and annoyance as well as tinnitus change during and after treatment . Audiologic and speech audiometric measurements will be performed to assess potential side effects . The aim of the present trail is to investigate effectiveness and safety of a four weeks cTBS treatment on chronic tinnitus and to compare two areas of stimulation . The results will contribute to clarify the therapeutic capacity of rTMS in tinnitus . Trial registration The trial was registered with the clinical trials register of http://www . clinical trials.gov ( NCT00518024 ) Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results Objective Pathophysiology of tinnitus known to accompany nearly all disorders in hearing system has not been fully understood , and therefore , there are some difficulties in evaluation and treatment thereof . The objective of the current study is to research the effectiveness of transcranial magnetic stimulation ( TMS ) application in treatment of tinnitus . Material s and Methods Sixty patients aged between 15 and 70 years who applied to a polyclinic of Ear-Nose-Throat Department , Cerrahpasa Medical Faculty , Istanbul University , because of the complaint of tinnitus between January 2009 and July 2009 were selected using simple r and om sampling method . The treatment group and the placebo group were separated r and omly as to include 30 patients . The tinnitus loudness , tinnitus frequency , tinnitus subjective score , and tinnitus h and icap inventory results were compared before application of TMS and after 1 month . Findings It was found that the difference of tinnitus h and icap inventory score within the TMS group ( before the treatment : mean , 52.76 ; SD , 15.8 ; after the treatment : mean , 44.4 ; SD , 13.57 ) was statistically significant ( P < 0.0001 ) and the difference of tinnitus h and icap inventory score within the placebo group ( before the treatment : mean , 51.46 ; SD , 15.41 ; after the treatment : mean , 51.13 ; SD , 16.86 ) was significantly insignificant ( P = 0.848 ) . When tinnitus severities determined at the beginning and end of the treatment were evaluated within each group , it was found that the difference of loudness within the group subjected to TMS was statistically significant ( P < 0.0001 ) but the difference of loudness within the placebo group was statistically insignificant ( P = 0.490 ) . When tinnitus subjective scores were evaluated within each group before and after the treatment , the difference of subjective score within the group subjected to transcranial magnetic stimulation was statistically significant ( P < 0.0001 ) , and the difference of subjective score within the placebo group was statistically significant ( P = 0.168 ) . Conclusions The studies showed that low-frequency repeating TMS is useful in the treatment of chronic tinnitus . In the current study performed on the patients with chronic tinnitus , it was shown that low-frequency repeating TMS has a statistically significant success when compared with the placebo group Objectives : Repetitive transcranial magnetic stimulation ( rTMS ) , a noninvasive method for altering cortical excitability , is becoming a therapeutic strategy in auditory research institutions worldwide . Application of inhibiting rTMS on these overactive cortical regions can result in effective tinnitus suppression . The aim of this study is to investigate the efficacy of theta-burst rTMS in patients with chronic tinnitus . Study Design : Parallel r and omized control study . Setting : Tertiary referral center . Patients : We enrolled 2 female and 20 male patients in this study . The evaluative tools included tinnitus frequency- and loudness-matching , tinnitus question naires ( TQ ) , and the Tinnitus H and icap Inventory ( THI ) . Methods : The orthogonal projection of the auditory cortex on the scalp was focalized . A figure-eight coil was placed on the surface of the skull over the targeted region with the intensity setting at 80 % of the resting motor threshold . We delivered 900 pulses of theta-burst rTMS daily for 10 business days . Main Outcome Measures : Nine of twelve patients ( 75 % ) in the active-stimulation group reported tinnitus suppression following treatment with rTMS . The treatment led to reductions of 8.58 and 8.33 in the mean TQ global and THI scores , respectively . Tinnitus loudness also decreased significantly after delivering rTMS . Results : Descriptive analysis of the TQs revealed that patients experienced significant improvements in emotional distress levels and somatic symptoms . Conclusions : Our preliminary results demonstrate that theta-burst rTMS treatments offer a method of modulating tinnitus . Patients could benefit from emotional improvements , even more than auditory perceptive relief . Further studies are needed to establish a st and ard protocol and to clarify nervous propagation along the auditory and psychological projection following treatment with rTMS We used PET to examine the pattern and time course of changes produced by repetitive transcranial magnetic stimulation ( rTMS ) over the dorsal premotor cortex ( PMd ) in healthy subjects and in patients with primary focal dystonia . Subjects received 1800 stimuli of subthreshold 1 Hz rTMS or sham stimulation to the left PMd . Afterwards , we measured regional cerebral blood flow ( rCBF ) as a marker of synaptic activity at rest and during performance of freely selected r and om finger movement . In both groups of subjects , real rTMS caused widespread bilateral decreases in neuronal activity in prefrontal , premotor , primary motor cortex , and left putamen . Conversely , rCBF in the cerebellum increased . Effects were equivalent at rest and during movement , indicating that the pattern of movement-related activation did not change . rTMS-induced changes in neuronal activity lasted for at least 1 h except in the medial aspect of the left globus pallidus . Conditioning effects on neuronal activity were larger in the patients than in the healthy subjects : there was a greater decrease of rCBF in lateral and medial premotor areas , putamen , and thalamus , including the stimulated premotor cortex , and a larger increase in cerebellar rCBF . Our findings indicate that , in healthy subjects and patients with dystonia , a single session of rTMS can produce powerful and widespread changes in regional synaptic activity as indexed by rCBF . Since the greater effects of premotor rTMS were not related to any differences in task performance , increased responsiveness of the motor system to rTMS reveals a physiological trait that characterizes patients with focal arm dystonia Background Chronic tinnitus is a frequent condition , which can have enormous impact on patient 's life and which is very difficult to treat . Accumulating data indicate that chronic tinnitus is related to dysfunctional neuronal activity in the central nervous system . Repetitive transcranial magnetic stimulation ( rTMS ) is a non-invasive method which allows to focally modulate neuronal activity . An increasing amount of studies demonstrate reduction of tinnitus after repeated sessions of low-frequency rTMS and indicate that rTMS might represent a new promising approach for the treatment of tinnitus . However available studies have been mono-centric and are characterized by small sample sizes . Therefore , this multi-center trial will test the efficacy of rTMS treatment in a large sample of chronic tinnitus patients . Methods / Design This is a r and omized , placebo-controlled , double-blind multi-center trial of two weeks 1 Hz rTMS-treatment in chronic tinnitus patients . Eligible patients will be r and omized to either 2 weeks real or sham rTMS treatment . Main eligibility criteria : male or female individuals aged 18–70 years with chronic tinnitus ( duration > 6 months ) , tinnitus-h and icap-inventory-score ≥ 38 , age-adjusted normal sensorineural hearing ( i.e. not more than 5 dB below the 10 % percentile of the appropriate age and gender group ( DIN EN ISO 7029 ) , conductive hearing loss ≤ 15dB. The primary endpoint is a change of tinnitus severity according to the tinnitus question naire of Goebel and Hiller ( baseline vs. end of treatment period ) . A total of 138 patients are needed to detect a clinical relevant change of tinnitus severity ( i.e. 5 points on the question naire of Goebel and Hiller ; alpha = 0.05 ; 1-beta = 0.80 ) . Assuming a drop-out rate of less than 5 % until the primary endpoint , 150 patients have to be r and omized to guarantee the target number of 138 evaluable patients . The study will be conducted by otorhinolaryngologists and psychiatrists of 7 university hospitals and 1 municipal hospital in Germany . Discussion This study will provide important information about the efficacy of rTMS in the treatment of chronic tinnitus . Trial registration Current Controlled Trials IS RCT Tinnitus is an auditory phantom percept with a tone , hissing or buzzing sound in the absence of any objective physical sound source . Tinnitus is considered to be an auditory phantom phenomenon analogous to somatosensory phantom pain . Controllable versus uncontrollable pain is characterized by an increased activity in the ventrolateral prefrontal cortex ( VLPFC ) , and activation in the VLPFC correlating with perceived control over pain results in a decrease in subjective pain intensity . Depressed individuals show less activation than healthy controls in the left VLPFC in response to sad autobiographical scripts , and greater relative left prefrontal activation is related to a greater disposition to approach-related , positive affect with a greater ability to regulate negative affect . Based on the theory that non-pulsatile tinnitus can be considered the auditory analogue for deafferentation pain , we hypothesize that the left VLPFC might also be involved in control of tinnitus . We conducted a transcranial magnetic stimulation ( TMS ) study verifying whether modulating the left VLPFC by TMS can modulate the loudness of tinnitus . We studied 60 patients with chronic tinnitus of which 21 patients received in r and om order sham and 1-Hz stimulation , while 39 patients received in r and om order sham and 10-Hz stimulation . Our results show that 10-Hz stimulation can modulate tinnitus loudness , while 1-Hz stimulation does not seem to exert the same effect . Our findings give further support to the fact that non-auditory areas are involved in tinnitus OBJECTIVE Clinical , neurophysiological and neuroimaging data suggest that chronic tinnitus resembles neuropsychiatric syndromes characterised by focal brain activation . Low frequency repetitive transcranial magnetic stimulation ( rTMS ) has been proposed as an efficient method in treating brain hyperexcitability disorders . METHODS Patients suffering from chronic tinnitus underwent a [ (18)F]deoxyglucose-PET ( positron emission tomography ) . Fusioning of the individual PET scan with the structural MRI-scan ( magnetic resonance imaging , T1 , MPRAGE ) revealed an increased metabolic activation in the primary auditory cortex as target point for rTMS . A neuronavigational system enabled the positioning of the figure of eight coil in relation to the target area . rTMS ( 110 % motor threshold ; 1 Hz ; 2000 stimuli/day over 5 days ) was performed using a placebo controlled cross-over design . RESULTS Following active rTMS there was a moderate improvement of tinnitus perception . Treatment effects lasted up to six months in some patients . CONCLUSIONS Neuronavigated rTMS offers new possibilities in the underst and ing and treatment of chronic tinnitus BACKGROUND Chronic severe tinnitus can be greatly detrimental to quality of life . Some authors have reported benefit of repetitive transcranial magnetic stimulation , others of electrical cortical stimulation by stimulating the Heschl 's gyrus or secondary auditory areas . OBJECTIVE To evaluate the efficacy of chronic electrical epidural stimulation of the auditory cortex on severe and disabling tinnitus . METHOD In this double-blind r and omized cross-over , patients with chronic ( at least 2 years ) , severe ( Strukturierte Tinnitus-Interview , STI score > 19 ) , unilateral or strongly lateralized tinnitus were included . After open-phase stimulation for 4 months , patients were r and omized into 2 groups for double-blind stimulation with cross-over between significant and non-significant phases and wash-out in between . Each of the 3 phases was 2 weeks in duration . Patients were chronically stimulated and followed if not explanted . A decrease of STI score > 35 % was considered as clinical ly significant . RESULTS None of the 9 patients included achieved significant improvement during the double-blind phase . Four were explanted , 2 owing to lack of effect , one for breast cancer under the stimulator , and another for psychiatric decompensation . Five are still stimulated . Three felt slight to great subjective effectiveness , the remaining 2 reported benefits and still requested stimulation . CONCLUSIONS This study did not find an objective efficiency of chronic cortical stimulation for severe and resistant tinnitus . The discordance between the results in double-blind and open evaluations could be related to a placebo effect of surgery , but may also be explained by a poorly defined target , a too short r and omized phase , or inappropriate outcome measures . Clinical trial reference : NCT00486577 Objective : To test whether 4 weeks of bilateral repetitive transcranial magnetic stimulation ( rTMS ) to the temporal or temporoparietal cortex is effective and safe in the treatment of chronic tinnitus . Methods : In this controlled 3-armed trial , 48 patients with chronic tinnitus were treated with 4 weeks ( 20 sessions ) of bilateral continuous theta burst stimulation ( cTBS ) at the Tübingen University Hospital . They were r and omized to stimulation above the temporal cortex , the temporoparietal cortex , or as sham condition behind the mastoid . Patients were masked for the stimulation condition . Tinnitus severity was assessed after 2 and primarily 4 weeks of treatment and at 3 months follow-up with the tinnitus question naire and by a tinnitus change score . Audiologic safety was monitored by pure-tone and speech audiometry after 2 and 4 weeks of cTBS . Results : Tinnitus severity was slightly reduced from baseline by a mean ( SD ) 2.6 ( 8.2 ) after sham , 2.4 ( 8.0 ) after temporoparietal , 2.2 ( 8.3 ) after temporal treatment of 16 patients each , but there was no significant difference between sham treatments and temporal ( confidence interval [ CI ] −5.4 to + 6.7 ) or temporoparietal cTBS ( CI −5.9 to + 6.3 ) or real cTBS ( CI −7 to + 5.1 ) . Patients ' global evaluation of tinnitus change after treatment did not indicate any effects . Audiologic measures were unaffected by treatment . Conclusions : Treating chronic tinnitus for 4 weeks by applying cTBS to the temporal or temporoparietal cortex of both hemispheres appears to be safe but not more effective than sham stimulation . However , these results are not to be generalized to all forms of rTMS treatments for tinnitus . Classification of Evidence : This study provides Class I evidence that bilateral cTBS is not effective in the treatment of chronic tinnitus Background A double cone coil ( DCC ) with large angled windings has been developed to modulate deeper brain areas such as the dorsal and subcallosal anterior cingulate cortex . Methods Seventy-eight tinnitus patients received transcranial magnetic stimulation ( TMS ) using a DCC placed over the dorsal frontal cortex . Treatment effects were assessed with visual analogue scale for intensity and distress . Results The results showed that 1 and 3 Hz of DCC frontal TMS can improve both tinnitus intensity and tinnitus distress , 5 Hz is equal to sham and 20 Hz is significantly worse than sham . Of the 78 tinnitus patients , 52 had no control response . Of these 52 placebo negative participants , 21 showed no suppressive response to stimulation and 31 patients were TMS responders . For this latter group , mean transient tinnitus suppression was obtained in 34.38 % for tinnitus intensity and in 26 % for tinnitus related distress . Conclusion Frontal TMS using a DCC is capable of suppressing tinnitus transiently dependent on the repetitive TMS frequency used . These data further support the idea that non-auditory areas are involved in tinnitus intensity and tinnitus distress modulation OBJECTIVES /HYPOTHESIS Electromagnetic therapy has been used with reported success in multiple clinical setting s , including the treatment of seizure disorders , brain edema , migraine headaches , revascularization of burn wounds , and diabetic ulcers . The purpose of the study was to investigate the effect of pulsed high-frequency electromagnetic therapy on chronic tinnitus . STUDY DESIGN A r and omized , prospect i ve , double-blind , placebo-controlled pilot study was conducted to evaluate the effectiveness of high-frequency pulsed electromagnetic energy using the Diapulse device in the treatment of chronic tinnitus . Thirty-seven adult patients with chronic tinnitus of at least 6 months ' duration were recruited and r and omly assigned to either a treatment or a placebo group . METHODS Patients received 30-minute treatments with the Diapulse device three times a week for 1 month . The unit was set to deliver electromagnetic energy at a frequency of 27.12 MHz at a repetition rate of 600 pulses per second . All subjects had pretreatment and post-treatment audiological testing , including tinnitus frequency and intensity matching . They responded to a tinnitus rating question naire and the Tinnitus H and icap Inventory before and after treatment . RESULTS There was no significant change in the pretreatment and post-treatment audiometric thresholds in either group . There were no significant differences between the pretreatment and post-treatment Tinnitus H and icap Inventory scores or the tinnitus rating scores in either subject group ( Student t test ) . No diagnosis-specific differences were identified . CONCLUSION High-frequency pulsed electromagnetic energy ( Diapulse ) at the setting s used in the study showed no role in the therapy of patients with chronic tinnitus BACKGROUND On the basis that tinnitus may result from neural hyperactivity in the auditory cortex , research ers have investigated the use of low frequency ( 1 Hz ) repetitive transcranial magnetic stimulation ( rTMS ) as a potential modulator of this hyperactivity . While these investigations show promise , investigations to date have neglected to consider the possible effect of 1 Hz rTMS on other functions of the auditory cortex of these individuals , such as auditory processing . OBJECTIVE /HYPOTHESIS This placebo-controlled pilot study aim ed to determine whether 1 Hz rTMS applied to the primary auditory cortex ( PAC ) , specifically Brodmann Area 41 ( BA41 ) , of adults with chronic , bilateral tinnitus would influence their auditory processing abilities . METHODS Eight participants with bilateral , chronic tinnitus were r and omized to receive a 10-day course of neuronavigationally guided active rTMS ( n = 4 ) or placebo rTMS ( n = 4 ) treatment applied to a focal region of the left PAC ( BA41 ) . Participants ' auditory processing was measured using Time Compressed Reverberant Speech and three-pair Dichotic Digits ( DD ) . Their tinnitus was measured using the Tinnitus H and icap Inventory ( THI ) and a psychoacoustic measure of tinnitus perception . All outcome measures were administered at baseline ( 1 week prior to rTMS ) , 1 week , 1 , 2 and 3 months post-rTMS . RESULTS All four participants in the active rTMS ( A ) group , and none of the participants in the sham ( placebo ) rTMS ( S ) group , showed improved auditory processing scores at multiple assessment points post-stimulation , with the group differences in median normalized gain scores reaching significance at the 5 % level from 1 week or 1 month post-stimulation onwards . Three of the four participants in the active rTMS ( A ) group , and none of the participants in the sham rTMS ( S ) group , showed improved tinnitus scores at multiple assessment points post-stimulation , with some of the group differences in median normalized gain scores reaching significance at the 5 % level . CONCLUSIONS The results of this preliminary study suggest that 1 Hz rTMS applied to the PAC ( BA41 ) has the capacity to improve both auditory processing and tinnitus perception in some adults with chronic , bilateral tinnitus BACKGROUND Repetitive transcranial magnetic stimulation ( rTMS ) applied over left temporoparietal cortex has been reported to have a long-term therapeutic effect on tinnitus . We compare the impact of 1 and 25 Hz rTMS delivered either contralateral or ipsilateral to symptoms in 62 patients with unilateral chronic tinnitus . MATERIAL AND METHODS Patients were r and omly assigned to one of four treatment groups : with stimulation at 1 or 25 Hz applied either ipsilateral or contralateral to symptoms . Two thous and pulses per session were given daily for 2 weeks . Changes in tinnitus h and icap inventory ( THI ) , self-rating scores of loudness , awareness , and annoyance were measured monthly for 10 months . Duration of residual inhibition ( RI ) and psychiatric morbidity were evaluated monthly for 3 months . RESULTS There was a significant main effect of time ( P < 0.0001 ) and a significant time x side interaction ( P = 0.032 ) between groups . This was because of the fact that contralateral stimulation had a greater effect on THI than ipsilateral stimulation ; it was also superior to left side stimulation ( P = 0.027 ) . Ratings of loudness improved more after contralateral rTMS ( P = 0.037 ) . Twenty patients had no remaining tinnitus after 3 months ; the remainder had a significant increase in RI . Patients with the shortest history of tinnitus tended to respond better to rTMS . There was a significant correlation between changes in THI score and changes in Hamilton anxiety and depression scores . CONCLUSION Ten daily treatments of 1 and 25 Hz rTMS contralateral to the side of tinnitus have a greater beneficial effect on symptoms than either ipsilateral or left side stimulation Objective : Transcranial magnetic stimulation ( TMS ) is already broadly used in different areas of neuroscience research . In the last years , special attention was drawn to TMS in tinnitus . The aim of our study is to investigate the stimulation characteristics of TMS in tinnitus patients , in particular the effect of tonic and burst stimulation of the superior temporal lobe . Study Design : Prospect i ve sham-controlled study . Setting : Tertiary referral center . Patients : Fifty tinnitus patients were included in the study . Thirty-one patients had pure-tone tinnitus , and 19 patients had noise-like tinnitus . Study Design : Transcranial magnetic stimulation was performed in 1 session of 200 pulses at different frequencies . Stimuli were delivered to the auditory cortex region contralateral to the tinnitus side . Tonic and burst stimulations were delivered at different frequencies . Patients were asked to rate the acute tinnitus reduction after TMS on a visual analog scale . Main Outcome Measure : Acutely perceived tinnitus reduction immediately after TMS , scored by the patient on a visual analogue scale ranging from 0 to 100 % . Results : Tinnitus reduction increased when stimulation intensity was higher relative to the patient 's motor threshold . Nevertheless , this stimulation intensity was shown only to account for 10 % of this increased tinnitus reduction , meaning that up to 90 % of this effect should be ascribed to other factors than stimulation intensity alone . Different reactions on TMS were found in bilateral tinnitus patients compared with unilateral tinnitus patients . Conclusion : Several parameters determine the amount of tinnitus reduction after TMS . An increased stimulation intensity relative to the patient 's motor threshold only accounts for 10 % of this effect . Our data also suggest different pathophysiologic mechanisms for unilateral and bilateral tinnitus Background : Chronic tinnitus is a disabling , almost untreatable , condition , usually accompanied by psychiatric distress . In patients with complex neuropsychiatric diseases , such as chronic pain , with which tinnitus shares pathophysiological similarities , placebo effects may be pronounced . Moreover , it may be difficult to distinguish actual repetitive transcranial magnetic stimulation ( rTMS ) induced clinical benefits beyond placebo effects in neuropsychiatric patients . Methods : 16 patients with chronic tinnitus underwent a r and omised , double blind , crossover , placebo controlled trial of 1 Hz rTMS ( 120 % of motor threshold ; 1200 stimuli/day for 5 days ) of the left temporoparietal region . Patients were screened for psychiatric comorbidity ; additionally , anxiety and depression were monitored throughout the study . Moreover , an original placebo rTMS procedure produced the same activation of ipsilateral face muscles ( a condition which may per se change the subjective rating of tinnitus ) as the real rTMS . Results : There were 8 out of 14 responders . Two patients dropped out for transient worsening of tinnitus . Active rTMS induced an overall significant , but transient , improvement ( 35 % of the basal score ) of subjective tinnitus perception that was independent of either tinnitus laterality or mood or anxiety changes . No correlations were found between response to rTMS and tinnitus duration , initial subjective score or patient age . When asked after the study was over , 71.4 % of patients failed to identify the temporal sequence of the real or sham rTMS interventions . Conclusion : The beneficial effects of rTMS on tinnitus are independent of mood changes . Moreover , they appear in the context of an original placebo stimulation design ed to more closely replicate the somatic sensation of active stimulation . Because of the limited temporal duration of the clinical benefit , these neuromodulatory effects could be mediated by transient functional changes taking place in the neural circuits underlying tinnitus processing Abstract We compared the effects of repetitive transcranial magnetic stimulation ( rTMS ) and paroxetine [ a selective serotonin reuptake inhibitor ( SSRI ) ] on tinnitus in terms of effectiveness and medium-term results . This is a r and omised , double-blind , placebo-controlled study . Seventy-five patients with moderate tinnitus were divided into five equal groups . Each group was treated for 1 month as follows : group 1 received rTMS alone at 1 Hz frequency ; group 2 received rTMS alone at 10 Hz frequency ; group 3 received rTMS at 1 Hz frequency combined with paroxetine ; group 4 received paroxetine alone ; and group 5 received a placebo ( sham rTMS ) . Participants were tested using the Tinnitus H and icap Inventory ( THI ) , Tinnitus Severity Index ( TSI ) , the Beck Anxiety Scoring ( BAS ) , and Psychiatric Sign Screening ( PSS ) tests . THI , TSI , BAS , and PSS were measured prior to treatment , and at the first and sixth month post-treatment . The THI and TSI scores improved after treatment in all groups , except the placebo group . The THI scores in groups 1 and 2 showed a statistically significant improvement after the first and sixth month compared to pretreatment scores , whereas a significant improvement in THI scores occurred only after the sixth month in groups 3 and 4 . The TSI scores in group 3 showed a significant improvement at the first and sixth month marks after treatment . The rTMS and SSRI play potential roles in the reduction of tinnitus severity , but without cumulative or synergistic effects when a combination of treatment regimens is applied . These positive effects might be due to the relationship between the auditory cortex areas related to emotions and tinnitus OBJECTIVE The pathophysiologic mechanisms of idiopathic tinnitus remain unclear . Low frequency rTMS applied over the auditory cortex has been proposed as a new and causally oriented treatment approach for pathological conditions with abnormal , increased cortical activity including tinnitus with increased activity in the auditory cortex . However available studies are characterized by a positive reports on the therapeutic effects of repetitive transcranial magnetic stimulation ( rTMS ) for treatment of tinnitus , there are few details about the duration of specific treatment effects . DESIGN The design of the study was r and omized , prospect i ve , placebo-controlled . Right-h and ed patients were treated with either real or sham 1 Hz frequency rTMS over a period of two weeks . Fifty-two patients with chronic , treatment resistant tinnitus and stable medication were enrolled in the study after giving written informed consent and forty-two patients completed the study and were included in data analysis . RESULTS The ability to reduce the symptoms of tinnitus appeared in both r and omized groups immediately after the 1 Hz rTMS and sham stimulation phase . There was a significant reduction in both groups of the tinnitus total score on the Tinnitus H and icap Inventory ( THI ) ( real rTMS p=0.005 ; sham rTMS p=0.049 ) and Tinnitus Question naire ( TQ ) total score ( real rTMS p=0.003 ; sham rTMS p=0.049 ) . On the THI evaluation scale , in the real rTMS a mild worsening was noted during week 6 in comparison with the state attained in week 2 . During the subsequent course of the study a significant reduction of the total score persisted in the case of THI ( real rTMS week 14 p=0.033 and borderline week 26 p=0.058 ) . The reduction of symptoms as evaluated using the TQ was significant compared to baseline in the real rTMS group at week 2 , 6 and 14 ( p=0.003 ; p=0.024 ; p=0.022 ) . The group treated with sham stimulation reached significant reduction of symptoms only at week 2 ( p=0.049 ) . A comparison of the difference in the recorded values of the total score during follow-up in relation to baseline expressed as a percentage demonstrates the difference in the effect of rTMS and sham stimulation as evaluated by both the basic scales . Graphical analysis of mean patterns of treatment response according to stimulation type shows a similarity between treatment response patterns evaluated by reduction of the total scores using THI and TQ . CONCLUSIONS The principal finding of this study is that real 1 Hz rTMS treatment was capable of significantly reducing the total baseline score of basic scales that measure tinnitus severity . This result is important as it proves that significant reduction of symptoms can be achieved even in a group of patients with long-term symptoms resistant to pharmacological treatment We compared the effect of different frequencies of repetitive transcranial magnetic stimulation ( rTMS ) ( 1 Hz , 10 Hz , 25 Hz and sham ( occipital , 1 Hz ) ) , given daily over the left temporoparietal cortex for 2 weeks , on 66 patients with chronic tinnitus r and omly divided into four treatment groups . Patients were assessed using the Tinnitus H and icap Inventory , self-ratings of symptoms and audiometric measures of residual inhibition before , immediately after 2 weeks ’ treatment and monthly thereafter for 4 consecutive months . Results : There were no significant differences in basal measures between the four groups of patients . A two-factor ANOVA revealed a significant “ rTMS ” × “ time ” interaction for all measures . This was because real rTMS produced greater improvement than sham . However , there was no significant difference between the responses to different frequencies of rTMS . The response to rTMS depended on the duration of tinnitus : patients who had tinnitus for the longest period of time were the least likely to respond to treatment . Conclusion : Daily sessions of rTMS over the temporoparietal cortex may be a useful potential treatment for tinnitus Abstract Objectives . Tinnitus is related to alterations in neuronal activity of auditory and nonauditory brain areas . Targeted modulation of these areas by repetitive transcranial magnetic stimulation ( rTMS ) has been proposed as a new therapeutic approach for chronic tinnitus . Methods . Two r and omized , double-blind , parallel-group , controlled clinical trials were performed subsequently and pooled for analysis . A total of 192 tinnitus patients were r and omly allocated to receive 10 stimulation sessions of either sham rTMS , PET-based neuronavigated 1 Hz rTMS , 1Hz r TMS over the left auditory cortex , or combined 20 Hz rTMS over the left frontal cortex , followed by 1 Hz rTMS over the left auditory cortex . Results . rTMS treatment was well tolerated and no severe side effects were observed . All active rTMS treatments result ed in significant reduction of the TQ as compared to baseline . The comparison between treatment groups failed to reach significant differences . The number of treatment responders was higher for temporal rTMS(38 % ) and combined frontal and temporal rTMS ( 43 % ) , as compared to sham ( 6 % ) . Conclusions . This large study demonstrates the safety and tolerability of rTMS treatment in patients with chronic tinnitus . While the overall effect did not prove superior to placebo , secondary outcome parameters argue in favour of the active stimulation groups , and specifically the combined frontal and temporal rTMS protocol |
1,317 | 22,829,225 | Despite the method ological limitations and heterogeneity of the systematic review s , there appears to be good evidence of effectiveness ( reliability and improved outcomes ) and feasibility ( use , satisfaction , acceptability and cost ) for videoconference-based telepsychiatry internationally . | OBJECTIVE A review of systematic review s of the effectiveness and feasibility of videoconference-based telepsychiatry services for re source constrained environments was conducted .
Specifically with the aim of producing an evidence -based review of the effectiveness and feasibility of videoconference-based telepsychiatry services in re source constrained countries like South Africa . | We carried out a pilot study comparing satisfaction levels between psychiatric patients seen face to face ( FTF ) and those seen via videoconference . Patients who consented were r and omly assigned to one of two groups . One group received services in person ( FTF from the visiting psychiatrist ) while the other was seen using videoconferencing at 128 kbit/s . One psychiatrist provided all the FTF and videoconferencing assessment and follow-up visits . A total of 24 subjects were recruited . Three of the subjects ( 13 % ) did not attend their appointments and two subjects in each group were lost to follow-up . Thus there were nine in the FTF group and eight in the videoconferencing group . The two groups were similar in most respects . Patient satisfaction with the services was assessed using the Client Satisfaction Question naire ( CSQ-8 ) , completed four months after the initial consultation . The mean scores were 25.3 in the FTF group and 21.6 in the videoconferencing group . Although there was a trend in favour of the FTF service , the difference was not significant . Patient satisfaction is only one component of evaluation . The efficacy of telepsychiatry must also be measured relative to that of conventional , FTF care before policy makers can decide how extensively telepsychiatry should be implemented Background Evidence -based practice s design ed for large urban clinics are not necessarily portable into smaller isolated clinics . Implementing practice -based collaborative care for depression in smaller primary care clinics presents unique challenges because it is often not feasible to employ on-site psychiatrists . Objective The purpose of the Telemedicine Enhanced Antidepressant Management ( TEAM ) study was to evaluate a telemedicine-based collaborative care model adapted for small clinics without on-site psychiatrists . Design Matched sites were r and omized to the intervention or usual care . Participants Small VA Community-based outpatient clinics with no on-site psychiatrists , but access to telepsychiatrists . In 2003–2004 , 395 primary care patients with PHQ9 depression severity scores ≥12 were enrolled , and followed for 12 months . Patients with serious mental illness and current substance dependence were excluded . Measures Medication adherence , treatment response , remission , health status , health-related quality of life , and treatment satisfaction . Results The sample comprised mostly elderly , white , males with substantial physical and behavioral health comorbidity . At baseline , subjects had moderate depression severity ( Hopkins Symptom Checklist , SCL-20 = 1.8 ) , 3.7 prior depression episodes , and 67 % had received prior depression treatment . Multivariate analyses indicated that intervention patients were more likely to be adherent at both 6 ( odds ratio [ OR ] = 2.1 , p = .04 ) and 12 months ( OR = 2.7 , p = .01 ) . Intervention patients were more likely to respond by 6 months ( OR = 2.0 , p = .02 ) , and remit by 12 months ( OR = 2.4 , p = .02 ) . Intervention patients reported larger gains in mental health status and health-related quality of life , and reported higher satisfaction . Conclusions Collaborative care can be successfully adapted for primary care clinics without on-site psychiatrists using telemedicine technologies BACKGROUND Mental illness has become a significant worldwide health issue in recent years . There is presently insufficient evidence to definitively determine the clinical effectiveness and cost-effectiveness of different health care models . The objective of this study was to evaluate the effectiveness of videoconferencing in mental illness . DATA SOURCES Literature search es were performed in Medline , EMBASE , PsycINFO , Centre for Review s and Dissemination , and The Cochrane Library Controlled Trial Registry data bases ( 1997-May 2008 ) . A search of the following terms was used : e-health , mental disorders ( MeSH term ) , mental health ( MeSH term ) , mental health services ( MeSH term ) , telecare , teleconsultation , telehome , telemedical , telemedicine , telemental , telepsychiatric , telepsychiatry , televideo , videoconference , and videophone . STUDY SELECTION Type of disease , interventions , and clinical outcomes or patient satisfaction were identified . Exclusion criteria included studies that did not analyze intervention outcomes and studies with a sample size of fewer than 10 cases . Peer review and quality assessment according to Cochrane recommendations were required for inclusion . DATA EXTRACTION / SYNTHESIS Of 620 identified articles , 10 r and omized controlled trials are included ( 1,054 patients with various mental disorders ) . There were no statistically significant differences between study groups for symptoms , quality of life , and patient satisfaction . CONCLUSIONS There is insufficient scientific evidence regarding the effectiveness of telepsychiatry in the management of mental illness , and more research is needed to further evaluate its efficiency . However , there is a strong hypothesis that videoconference-based treatment obtains the same results as face-to-face therapy and that telepsychiatry is a useful alternative when face-to-face therapy is not possible Therapist adherence to a manualized cognitive-behavioral anger management group treatment ( AMT ) was compared between therapy delivered via videoconference ( VC ) and the traditional in-person modality , using data from a large , r and omized controlled trial comparing the effectiveness of AMT for veterans with combat-related posttraumatic stress disorder . Therapist adherence was rated for the presence or absence of process and content treatment elements . Secondary analyses were conducted using a repeated measures ANOVA . Overall adherence to the protocol was excellent ( M = 96 % , SD = 1 % ) . Findings indicate that therapist adherence to AMT is similar across delivery modalities and VC is a viable service delivery strategy that does not compromise a therapist 's ability to effectively structure sessions and manage patient care We compared the efficacy of telepsychiatry and same-room treatment of combat-related post-traumatic stress disorder ( PTSD ) using cognitive behavioural therapy in 14 weekly , 90-min treatment sessions . Of 97 patients referred for study participation , 38 were r and omized ( 17 into telepsychiatry , 21 into same-room ) , and approximately 25 ( the number differed by instrument ) had at least one post-baseline assessment . Measures of clinical and process outcomes were examined . No group differences were found on clinical outcomes at three-month follow-up . Satisfaction with treatment ratings was similar in both groups , with ' strong satisfaction ' indicated by veterans in both modalities . Attendance and drop-out were similar in the two groups . The same-room group reported more comfort in talking with their therapist at post-treatment and had better treatment adherence . The results provide preliminary support for the use of telepsychiatry in the treatment of PTSD to improve access to care Little is known about whether the recommendations made during telepsychiatry are actually implemented . We review ed 100 telepsychiatry consultations , chosen r and omly from a paediatric telepsychiatry programme serving rural communities in Ontario . Treatment recommendations had been made for each case review ed and up to nine recommendations had been made for a single case . Twenty-seven percent of recommendations revolved around monitoring ( 10 % ) , changing ( 9 % ) , starting ( 4 % ) , continuing ( 3 % ) and stopping ( 1 % ) medication . Case managers associated with 54 of the cases were interviewed to determine whether the recommendations had been implemented and to examine the barriers and facilitators to implementation . The results indicated that cooperation of both child and parent , clear communication of recommendations , involvement of the school and local health providers , stability of the agencies and availability of services were key components in the successful implementation of recommendations . The matter of technology or technological difficulties acting as a barrier to telepsychiatric consultations was not mentioned by case managers , suggesting that it was not a problem We used a PC-based videoconferencing system to conduct child psychiatry assessment s. The telecommunications link was six digital lines , giving a total b and width of 336 kbit s. Twenty-three patients aged 4 - 16 years , accompanied by their parents , completed two psychiatric assessment s , one via videoconferencing and another face to face FTF . The order of assessment s was r and omized . Question naires were used to record the diagnosis , treatment recommendations and the psychiatrists ' , patients ' and their parents ' satisfaction with each assessment . An independent evaluator concluded that in 22 cases 96 the diagnosis and treatment recommendations made via the videoconferencing system were the same as those made FTF . The psychiatrists stated that videoconferencing assessment s were an adequate alternative to FTF assessment s and did not interfere with diagnosis . However , the responses from the psychiatrist satisfaction question naire showed that they preferred FTF assessment s. No significant difference was found in the patients ' or parents ' satisfaction responses after the two types of assessment . The majority of children 82 liked ' using the telepsychiatry system and six 26 preferred it to a FTF assessment . Most parents 91 indicated that they would prefer to use the videoconferencing system than to travel a long distance to see a psychiatrist in person To investigate whether forensic evaluations can be performed reliably using telemedicine , we compared the results on a st and ard competency assessment instrument using telemedicine ( TM ) and live interviews ( LI ) . Two board-certified forensic psychiatrists used the Georgia Court Competency Test ( GCCT ) to evaluate 21 forensic psychiatric in patients . Half of the patients were r and omly assigned to a telemedicine interview and half were assigned to a live interview . Total scores on the GCCT were similar for both raters , indicating high levels of agreement between telemedicine and live interviews . Patient and provider satisfaction were measured and indicated that , although patients did not express a preference for a particular interview modality , providers reported greater satisfaction with live interviews . Findings suggest that one aspect of competency to st and trial can be reliably evaluated using telemedicine and that patients perceive telemedicine as an acceptable alternative to a st and ard live interview . The limited sample size precludes definite conclusions and further studies involving a larger forensic study population are warranted OBJECTIVE A major problem in the delivery of mental health services is the lack of availability of empirically supported treatment , particularly in rural areas . To date no studies have evaluated the administration of an empirically supported manual-based psychotherapy for a psychiatric condition via telemedicine . The aim of this study was to compare the relative efficacy and acceptability of a manual-based cognitive-behavioral therapy ( CBT ) for bulimia nervosa ( BN ) delivered in person to a comparable therapy delivered via telemedicine . METHOD One hundred twenty-eight adults meeting DSM-IV criteria for BN or eating disorder-not otherwise specified with binge eating or purging at least once per week were recruited through referrals from clinicians and media advertisements in the targeted geographical areas . Participants were r and omly assigned to receive 20 sessions of manual-based , CBT for BN over 16 weeks delivered either face-to-face ( FTF-CBT ) or via telemedicine ( TV-CBT ) by trained therapists . The primary outcome measures were binge eating and purging frequency as assessed by interview at the end of treatment , and again at 3- and 12-month follow-ups . Secondary outcome measures included other bulimic symptoms and changes in mood . RESULTS Retention in treatment was comparable for TV-CBT and FTF-CBT . Abstinence rates at end-of-treatment were generally slightly higher for FTF-CBT compared with TV-CBT , but differences were not statistically significant . FTF-CBT patients also experienced significantly greater reductions in eating disordered cognitions and interview-assessed depression . However , the differences overall were few in number and of marginal clinical significance . CONCLUSIONS CBT for BN delivered via telemedicine was both acceptable to participants and roughly equivalent in outcome to therapy delivered in person Background Older adults who live in rural areas experience significant disparities in health status and access to mental health care . " Telepsychology , " ( also referred to as " telepsychiatry , " or " telemental health " ) represents a potential strategy towards addressing this longst and ing problem . Older adults may benefit from telepsychology due to its : ( 1 ) utility to address existing problematic access to care for rural residents ; ( 2 ) capacity to reduce stigma associated with traditional mental health care ; and ( 3 ) utility to overcome significant age-related problems in ambulation and transportation . Moreover , preliminary evidence indicates that telepsychiatry programs are often less expensive for patients , and reduce travel time , travel costs , and time off from work . Thus , telepsychology may provide a cost-efficient solution to access-to-care problems in rural areas . Methods We describe an ongoing four-year prospect i ve , r and omized clinical trial comparing the effectiveness of an empirically supported treatment for major depressive disorder , Behavioral Activation , delivered either via in-home videoconferencing technology ( " Telepsychology " ) or traditional face-to-face services ( " Same-Room " ) . Our hypothesis is that in-homeTelepsychology service delivery will be equally effective as the traditional mode ( Same-Room ) . Two-hundred twenty-four ( 224 ) male and female elderly participants will be administered protocol -driven individual Behavioral Activation therapy for depression over an 8-week period ; and subjects will be followed for 12-months to ascertain longer-term effects of the treatment on three outcomes domains : ( 1 ) clinical outcomes ( symptom severity , social functioning ) ; ( 2 ) process variables ( patient satisfaction , treatment credibility , attendance , adherence , dropout ) ; and ( 3 ) economic outcomes ( cost and re source use ) . Discussion Results from the proposed study will provide important insight into whether telepsychology service delivery is as effective as the traditional mode of service delivery , defined in terms of clinical , process , and economic outcomes , for elderly patients with depression residing in rural areas without adequate access to mental health services . Trial registration National Institutes of Health Clinical Trials Registry ( Clinical Trials.gov identifier # NCT00324701 ) Effective cognitive-behavioral treatments for childhood depression have developed over the last decade , but many families face barriers to such care . Telemedicine increases access to psychological interventions by linking the child and the clinician using videoconferencing ( VC ) . The current study evaluated an 8-week , cognitive-behavioral therapy ( CBT ) intervention for childhood depression either face-to-face ( F2F ) or over VC . The telemedicine setup included two PC-based PictureTel systems at 128 kilibits per second ( kbps ) . Success was defined by ( 1 ) decreasing depressive symptoms at similar rates in both the VC group and the F2F group and ( 2 ) demonstrating the feasibility of a r and omized controlled trial in telemental health . Children were assessed for childhood depression using the mood section of the Schedule for Affective Disorders and Schizophrenia for School Age Children-Present Episode ( K-SADS-P ) . Twenty-eight children were r and omized to either F2F or VC treatment . The participants completed the K-SADS-P and the Children 's Depression Inventory ( CDI ) at pre- and post-treatment . The CBT treatment across the two conditions was effective . The overall response rate based on post-evaluation with the K-SADS-P was 82 % . For the CDI total score , both the Time and the Group by Time effects were significant ( p < 0.05 ) . The interaction effect reflected a faster rate of decline in the CDI total score for the VC group . The study serves as a model for building on past research to implement a r and omized controlled trial . This information provides persuasive research data concerning treatment effectiveness for clinicians , families , and funders BACKGROUND Memory complaints and decline in cognitive function are common in the elderly . Cognitive intervention has been shown to be beneficial in Alzheimer 's disease ( AD ) . However , few community-based cognitive intervention programs are available in Hong Kong . The aim of this project is to examine and compare the feasibility , acceptability , and clinical outcome of a cognitive intervention program for older patients with mild cognitive impairment and mild dementia using telemedicine versus a conventional face-to-face method . METHODS Community-dwelling older subjects with mild dementia or mild cognitive impairments were recruited from a community center . A total of 12 sessions of assessment and cognitive intervention were conducted via videoconferencing or by face-to-face method . Assessment included : Cantonese version of Mini Mental State Examination ( C-MMSE ) , Cantonese version of Rivermead Behavioural Memory test ( C-RBMT ) and Hierarchic Dementia Scale ( HDS ) . RESULTS Twenty-two clients were recruited . There was significant and comparable cognitive improvement in clients in both treatment arms . The videoconference arm was highly accepted by the clients and the community center . Overall compliance rate of participants was above 95 % . CONCLUSIONS Telemedicine was a feasible , effective and acceptable means in providing cognitive assessment and intervention to older persons with mild cognitive deficits . Promoting such a program to other community setting s would further enhance the accessibility of dementia service to the community A study was carried out to describe the patient population assessed by a telepsychiatry consultation-liaison service in rural South Australia , and to assess the referrers ’ and patients ’ satisfaction rating with this service . The study was performed in two parts , with retrospective and prospect i ve components . The author completed a semi-structured interview for each patient ( n=75 ) with a Brief Psychiatric Rating Scale ( BPRS ) for the prospect i ve group ( n=32 ) . A question naire was also sent to all referrers seeking an evaluation of the usefulness of the telepsychiatry interview in terms of assessment and management recommendations and outcome . Patients from the prospect i ve group were sent a question naire examining their evaluation of the usefulness of the interview in terms of assessment and management recommendations , and difficulties with the technology . The patient population was characterized by high rates of affective disorder and personality disorder , and high indices of developmental disturbance . Referrers reported high rates of satisfaction with the service . Nursing staff rated the service more positively than general practitioners . The usefulness for assessment was rated more highly than for management Telemedicine is the provision of professional medical services from sites removed from the patient . This study was conducted in order to assess the reliability of psychiatric evaluations via video-consultation . The inter-rater reliability was determined for each interviewing condition by employing the reliability-testing paradigm in which the brief psychiatric rating scale ( BPRS ) and the interclass correlation coefficient ( ICC ) are used . The inter-rater reliability scores between face-to-face interviews and interviews conducted by video at two different levels of image qualities were compared by the authors . Reliability was found to be in perfect agreement in each of the interviewing conditions . This study verifies that telepsychiatry is a reliable method of assessing patient conditions . It may be used to provide much needed mental health-care services to patients whose access to them is restricted BACKGROUND Dementia is a common but frequently undiagnosed problem in aging . Barriers to early diagnosis include a lack of routine screening for dementia and a lack of access to specialty consultative services . We conducted a pilot study to see if telemedicine could provide reliable , accurate geriatric consultative services to evaluate patients for dementia who were residing at remote sites . METHODS This was a prospect i ve cohort study that compared the diagnostic reliability of telemedicine to an in-person examination for dementia . Eligible subjects were residents of a Washington State Veterans ' Home , age 60 years or older , with no prior diagnosis of dementia . Eligible subjects were screened for dementia using the 7-Minute Screen . Veterans who screened positive and consented to participate in the study received an in-person neuropsychiatric evaluation at baseline , and then both telemedicine and in-person examinations for dementia conducted by experienced geriatric psychiatrists . The accuracy of the telemedicine diagnosis was estimated by comparing it to the diagnosis from the clinical examination . Three geriatric psychiatrists who were blinded to the results of the clinical examination conducted the telemedicine and in-person examinations . We also assessed attitudes of the subjects and geriatric psychiatrists towards the telemedicine sessions . RESULTS Eighteen of 85 subjects screened were ' positive ' for dementia on the 7 Minute Screen . Of these , 16 consented to participate in the telemedicine study . Twelve of the 16 subjects were subsequently diagnosed with dementia by the telemedicine examination . The telemedicine diagnoses were in 100 % agreement with the diagnoses from the in-person clinical examinations . Moreover , the subjects reported a high degree of satisfaction with the telemedicine experience and that they would like to have further care through telemedicine in the future . The geriatric psychiatrists reported technical difficulties with the audio-visual quality of telemedicine in the initial phases of the project that resolved as familiarity with the telemedicine equipment increased . None of these problems had an adverse impact on the diagnostic accuracy of telemedicine . CONCLUSIONS We found that telemedicine was as accurate as an in-person clinical examination in establishing the diagnosis of dementia . In addition , subjects reported a high degree of satisfaction with telemedicine and a willingness to participate in telemedicine clinical care in the future . Given the large increase in the aging population and the shortage of geriatric psychiatrists nationally , it appears that telemedicine may be a promising means to exp and the availability of geriatric psychiatric consultation to remote areas OBJECTIVE The use of interactive videoconferencing to provide psychiatric services to geographically remote regions , often referred to as telepsychiatry , has gained wide acceptance . However , it is not known whether clinical outcomes of telepsychiatry are as good as those achieved through face-to-face contact . This study compared a variety of clinical outcomes after psychiatric consultation and , where needed , brief follow-up for out patients referred to a psychiatric clinic in Canada who were r and omly assigned to be examined face to face or by telepsychiatry . METHODS A total of 495 patients in Ontario , Canada , referred by their family physician for psychiatric consultation were r and omly assigned to be examined face to face ( N=254 ) or by telepsychiatry ( N=241 ) . The treating psychiatrists had the option of providing monthly follow-up appointments for up to four months . The study tested the equivalence of the two forms of service delivery on a variety of outcome measures . RESULTS Psychiatric consultation and follow-up delivered by telepsychiatry produced clinical outcomes that were equivalent to those achieved when the service was provided face to face . Patients in the two groups expressed similar levels of satisfaction with service . An analysis limited to the cost of providing the clinical service indicated that telepsychiatry was at least 10 % less expensive per patient than service provided face to face . CONCLUSIONS Psychiatric consultation and short-term follow-up can be as effective when delivered by telepsychiatry as when provided face to face . These findings do not necessarily mean that other types of mental health services , for example , various types of psychotherapy , are as effective when provided by telepsychiatry Delivering psychotherapy by videoconference could significantly increase the accessibility of empirically vali date d treatments . The aim of this study was to compare the effectiveness of cognitive-behavior therapy ( CBT ) for panic disorder with agoraphobia ( PDA ) when the therapy is delivered either face-to-face or by videoconference . A sample of 21 participants was treated either face-to-face or by videoconference . Results showed that CBT delivered by videoconference was as effective as CBT delivered face-to-face . There was a statistically significant reduction in all measures , and the number of panic-free participants among those receiving CBT by videoconference was 81 % at post-treatment and 91 % at the 6-month follow-up . None of the comparisons with face-to-face psychotherapy suggested that CBT delivered by videoconference was less effective . These results were confirmed by analyses of effect size . The participants reported the development of an excellent therapeutic alliance in videoconference as early as the first therapy session . The importance of these results for treatment accessibility is discussed . Hypotheses are proposed to explain the rapid creation of strong therapeutic alliances in videoconferencing Background Telemedicine is the use of telecommunications technology for medical diagnosis and patient care . From its beginnings telemedicine has been used in a variety of health care fields , although widespread interest among healthcare providers has only now become apparent with the development of more sophisticated technology . Objectives To assess the effects of telemedicine as an alternative to face-to-face patient care . Search methods We search ed the Effective Practice and Organisation of Care Group 's specialised register , The Cochrane Library , MEDLINE ( 1966-August 1999 ) , EMBASE ( to 1996 ) , CINAHL ( to August 1999 ) , Inspec ( to August 1996 ) , Healthstar ( 1983 - 1996 ) , OCLC , Sigle ( to 1999 ) , Assia , SCI ( 1981 - 1997 ) , SSCI ( 1981 - 1997 ) , DHSS- Data . We h and search ed the Journal of Telemedicine and Telecare ( 1995 - 1999 ) , Telemedicine Journal ( 1995 - 1999 ) and reference lists of articles . We also h and search ed conference proceedings and contacted experts in countries identified as having an interest in telemedicine . Selection criteria R and omised trials , controlled before and after studies and interrupted time series comparing telemedicine with face-to-face patient care . The participants were qualified health professionals and patients receiving care through telemedicine . Data collection and analysis Two review ers independently assessed trial quality and extracted data . Main results Seven trials involving more than 800 people were included . One trial was concerned with telemedicine in the emergency department , one with video-consultations between primary health care and the hospital out patients department , and the remainder were concerned with the provision of home care or patient self-monitoring of chronic disease . The studies appeared to be well conducted , although patient numbers were small in all but one . Although none of the studies showed any detrimental effects from the interventions , neither did they show unequivocal benefits and the findings did not constitute evidence of the safety of telemedicine . None of the studies included formal economic analysis . All the technological aspects of the interventions appear to have been reliable , and to have been well accepted by patients . Authors ' conclusions Establishing systems for patient care using telecommunications technologies is feasible , but there is little evidence of clinical benefits . The studies provided variable and inconclusive results for other outcomes such as psychological measures , and no analysable data about the cost effectiveness of telemedicine systems . The review demonstrates the need for further research and the fact that it is feasible to carry out r and omised trials of telemedicine applications . Policy makers should be cautious about recommending increased use and investment in unevaluated technologies Although telepsychiatry in the form of videoconferencing has been well received in terms of increasing access to care and user satisfaction , few data on treatment outcomes and efficacy from telepsychiatry applications are available at the present time . This paper evaluates the efficacy of telepsychiatry through videoconference in the treatment of mental disorders by comparing to face-to-face conventional ( F2FC ) treatment . We carried out a r and omized clinical trial where 140 psychiatric out patients were r and omized to either F2FC treatment or videoconference telepsychiatry ( VCTP ) treatment . Patients were diagnosed according to International Classification of Diseases , 10th edition ( ICD-10 ) criteria using the Composite International Diagnostic Interview . Treatment involves eight consultations lasting 30 minutes over the 24-week study period . Patients received pertinent psychotropic medication plus cognitive- behavioral therapy during sessions . The same psychiatrist diagnosed and treated all the patients that were recruited from the Community Mental Health Centre of San Sebastian de la Gomera , in the Canary Isl and s. Change in psychiatric test scores served as the primary efficacy criterion . Efficacy was determined by comparing baseline ( visit 1 ) Clinical Global Impressions-Severity of Illness ( CGI-S ) and -Improvement ( CGI-I ) scales as well as Global Indexes ( GSI , PSDI , and PST ) from SCL-90R with scores obtained at the end of the study period ( week 24 ) . Response was defined as a CGI-I score of 1 or 2 . Reliable Change Indexes were computed in SCL-90R Global Indexes scores . Of 140 patients r and omized , 130 completed 24 weeks of treatment . Only 4 patients dropped out prematurely from the study in VCTP and 6 in F2FC . The study involves 534 teleconsultations , 522 F2FC consultations , and more than 500 hours of clinical practice . Significant improvements were found on the CGI and SCL-90- R Global Indexes scores of both treatment groups , showing clear clinical state improvement . No statistically significant differences were observed when the efficacy of VCTP treatment was compared to F2FC psychiatric treatment efficacy . This study demonstrated that telepsychiatry treatment through videoconference has equivalent efficacy to F2FC psychiatric treatment . Telepsychiatry showed to be an effective mean of delivering mental health services to psychiatric out patients living in remote areas with limited re sources The process and outcome of clinical tasks in an acute psychiatric unit were compared using four different communication modes : face to face , telephone , h and s-free telephone , and a low-cost videoconferencing system . Six doctors and six patients took part in the study . Four assessment measures were used . The videoconferencing system was positively received by both patients and doctors . Both doctors and patients preferred communication modes with visual cues . However , there were few significant differences between communication modes when using single measures ; only multiple levels of analysis can adequately assess the differences between such modes of communication OBJECTIVE Telepsychiatry is an increasingly common method of providing psychiatric care , but r and omized trials of telepsychiatric treatment compared to in-person treatment have not been done . The primary objective of this study was to compare treatment outcomes of patients with depressive disorders treated remotely by means of telepsychiatry to outcomes of depressed patients treated in person . Secondary objectives were to determine if patients ' rates of adherence to and satisfaction with treatment were as high with telepsychiatric as with in-person treatment and to compare costs of telepsychiatric treatment to costs of in-person treatment . METHOD In this r and omized , controlled trial , 119 depressed veterans referred for outpatient treatment were r and omly assigned to either remote treatment by means of telepsychiatry or in-person treatment . Psychiatric treatment lasted 6 months and consisted of psychotropic medication , psychoeducation , and brief supportive counseling . Patients ' treatment outcomes , satisfaction , and adherence and the costs of treatment were compared between the two conditions . RESULTS Hamilton Depression Rating Scale and Beck Depression Inventory scores improved over the treatment period and did not differ between treatment groups . The two groups were equally adherent to appointments and medication treatment . No between-group differences in dropout rates or patients ' ratings of satisfaction with treatment were found . Telepsychiatry was more expensive per treatment session , but this difference disappeared if the costs of psychiatrists ' travel to remote clinics more than 22 miles away from the medical center were considered . Telepsychiatry did not increase the overall health care re source consumption of the patients during the study period . CONCLUSIONS Remote treatment of depression by means of telepsychiatry and in-person treatment of depression have comparable outcomes and equivalent levels of patient adherence , patient satisfaction , and health care cost People over the age of 65 were recruited from an inner-city old-age psychiatry service . Subjects had a structured interview ( the CAMCOG test ) by videoconferencing , and also face to face , by an investigator blind to the results of the test in the other mode . Re assessment s were carried out within one week of the initial assessment . Eleven subjects were initially enrolled in the study and eight completed both modes . The number of patients in this study is very small but the results suggest that the CAMCOG test can be used reliably over a videoconferencing system without major modification |
1,318 | 17,655,743 | ConclusionS mall improvements in knowledge , skills , attitudes or behavior are noted when measured alone .
A large improvement in skills and knowledge in EBP is noted when measured together in a total test score . | Background Training in Evidence -Based Practice ( EBP ) has been widely implemented throughout medical school and residency curricula .
The aim of this study is to systematic ally review studies that assessed the effectiveness of EBP teaching to improve knowledge , skills , attitudes and behavior of postgraduate healthcare workers , and to describe instruments available to evaluate EBP teaching . | OBJECTIVES : Several studies have evaluated whether evidence -based medicine ( EBM ) training courses can improve skills such as literature search ing and critical appraisal but to date , few data exist on whether teaching EBM skills and providing evidence -based re sources result in change in behavior or clinical outcomes . This study was conducted to evaluate whether a multifaceted EBM intervention consisting of teaching EBM skills and provision of electronic evidence re sources changed clinical practice . DESIGN : Before/after study . SETTING : The medical inpatient units at a district general hospital . PARTICIPANTS : Thirty-five attending physicians and 12 medicine residents . INTERVENTION : A multicomponent EBM intervention was provided including an EBM training course of seven 1-hour sessions , an EBM syllabus and textbook , and provision of evidence -based re sources on the hospital network . MEASUREMENTS AND MAIN RESULTS : The primary outcome of the study was the quality of evidence in support of therapies initiated for the primary diagnoses in 483 consecutive patients admitted during the month before and the month after the intervention . Patients admitted after implementation of the EBM intervention were significantly more likely to receive therapies proven to be beneficial in r and omized controlled trials ( 62 % vs 49 % ; P=.016 ) . Of these trial-proven therapies , those offered after the EBM intervention were significantly more likely to be based on high- quality r and omized controlled trials ( 95 % vs 87 % ; P=.023 ) . CONCLUSIONS : A multifaceted intervention design ed to teach and support EBM significantly improved evidence -based practice patterns in a district general hospital Abstract OBJECTIVE : To determine if a simple educational intervention can increase resident physician literature search activity . DESIGN : R and omized controlled trial . SETTING : University hospital-based internal medicine training program . PATIENTS / PARTICIPANTS : Forty-eight medical residents rotating on the general internal medicine service . INTERVENTIONS : One-hour didactic session , the use of well-built clinical question cards , and practical sessions in clinical question building . MEASUREMENTS AND MAIN RESULTS : Objective data from the library information system that included the number of log-ons to MEDLINE , search ing volume , abstract s viewed , full-text articles viewed , and time spent search ing . Median search activity as measured per person per week ( control vs intervention ) : number of log-ons to MEDLINE ( 2.1 vs 4.4 , P<.001 ) ; total number of search sets ( 24.0 vs 74.2 , P<.001 ) ; abstract s viewed ( 5.8 vs 17.7 , P=.001 ) ; articles viewed ( 1.0 vs 2.6 , P=.005 ) ; and hours spent search ing ( 0.8 vs 2.4 , P<.001 ) . CONCLUSIONS : A simple educational intervention can markedly increase resident search ing activity Background Previous studies have shown that Norwegian public health physicians do not systematic ally and explicitly use scientific evidence in their practice . They work in an environment that does not encourage the integration of this information in decision-making . In this study we investigate whether a theoretically grounded tailored intervention to diffuse evidence -based public health practice increases the physicians ' use of research information . Methods 148 self-selected public health physicians were r and omised to an intervention group ( n = 73 ) and a control group ( n = 75 ) . The intervention group received a multifaceted intervention while the control group received a letter declaring that they had access to library services . Baseline assessment s before the intervention and post-testing immediately at the end of a 1.5-year intervention period were conducted . The intervention was theoretically based and consisted of a workshop in evidence -based public health , a newsletter , access to a specially design ed information service , to relevant data bases , and to an electronic discussion list . The main outcome measure was behaviour as measured by the use of research in different documents . Results The intervention did not demonstrate any evidence of effects on the objective behaviour outcomes . We found , however , a statistical significant difference between the two groups for both knowledge scores : Mean difference of 0.4 ( 95 % CI : 0.2–0.6 ) in the score for knowledge about EBM-re sources and mean difference of 0.2 ( 95 % CI : 0.0–0.3 ) in the score for conceptual knowledge of importance for critical appraisal . There were no statistical significant differences in attitude- , self-efficacy- , decision-to-adopt- or job-satisfaction scales . There were no significant differences in Cochrane library search ing after controlling for baseline values and characteristics . Conclusion Though demonstrating effect on knowledge the study failed to provide support for the hypothesis that a theory-based multifaceted intervention targeted at identified barriers will change professional behaviour BACKGROUND AND OBJECTIVES Medical education experts have called for improved training in evidence -based medicine ( EBM ) and the increased use of e-learning technologies in medical education . In response , we developed an interactive , Web-based curriculum on key aspects of EBM in family medicine . METHODS Students participating in a 6-week family medicine clerkship ( n=238 ) were r and omly assigned to intervention ( n=134 ) or control ( n=104 ) groups . Both groups participated in the traditional clerkship experience , but intervention group students received additional training via an on-line curriculum that included learning modules in MEDLINE search ing skills , EBM skills , and the calculation of the number needed to treat ( NNT ) statistic . The on-line curriculum was evaluated using a case-control design with a test case at the clerkship 's end . RESULTS Results suggested that the on-line curriculum was effective , with experimental group students outperforming control group participants on a variety of measures , including the number of MEDLINE search es conducted during the clerkship ( 13 search es versus 3 search es ) and the quality of literature search strategies on an evaluation patient case study ( 2.9 versus 2.1 on a 1=poor to 4=excellent scale ) . Intervention group students reported greater confidence and enjoyment in search ing the biomedical journal literature via MEDLINE and were more likely to identify the best articles ( r and omized controlled trials or meta-analyses ) for the evaluation case from among those retrieved ( 60 % versus 34 % ) . In addition , intervention group students ' abilities to correctly calculate the NNT were significantly higher than those of control group participants ( 73 % versus 27 % ) . Intervention group students were more likely than control subjects to report learning from other students during the clerkship . CONCLUSIONS This study demonstrates that an e-learning approach to educating medical students to effectively search MEDLINE for articles meeting the criteria for evidence -based practice can result in higher- quality literature search strategies , identification of higher- quality evidence , and improved confidence in information retrieval and analysis skills OBJECTIVE To determine if a preceptor and individualized feedback improves the performance of physicians in search ing MEDLINE in clinical setting s. DESIGN R and omized controlled trial with 2 to 10 months follow-up . SETTING A 300-bed teaching hospital . PARTICIPANTS All 392 physicians and physicians-in-training from 6 major clinical departments were invited to participate if they made patient-care decisions during the study period ; 79.4 % agreed . INTERVENTIONS All participants were given 2 hours of basic training , then r and omized to a control group ( no further intervention ) or an intervention group in which each person chose a clinical preceptor experienced in MEDLINE search ing and received individualized feedback from a study librarian on each of their 1st 10 search es . MAIN OUTCOME MEASURES The number and proportion of relevant and irrelevant references retrieved for 1st , 4th , and 8th search es of participants were compared with independent librarian search es on the same topics . RESULTS Intervention group members did not search more often than controls ( 5.9 search es per month versus 4.7 , respectively ; P = 0.26 ) and there were no significant differences in the quality of search es . Rather , search performance for both groups improved , with the average number of relevant references retrieved per search increasing from 4.5 to 7.4 ( P < 0.01 ) . The librarian retrieved more relevant citations than participants for the 1st search ( P = 0.001 ) but not for the 4th ( P = 0.60 ) or 8th ( P = 0.76 ) search es . CONCLUSIONS A program of assigning preceptors and providing feedback on individual search es did not enhance the quantity or quality of search es . Soon after a basic introduction to search ing , however , clinicians in both groups improved their search performance Objective To determine whether fellowship training in critical care medicine with critical appraisal exercises improves the ability and confidence of fellows to evaluate the medical literature . Design Prospect i ve , interventional pilot study . Setting Multidisciplinary critical care medicine training program at a large university hospital . InterventionFellows were given three didactic sessions covering study design , analysis , and critical appraisal techniques . During the course of the year , each fellow was required to review one article from the literature and present a critique of this article to the group and faculty ( Journal Club ) . Fellows were guided in the preparation of this presentation by one of the critical care medicine faculty . Finally , a written analysis and critique of the article was performed by each fellow . Measurements and Main Results A test was given to each fellow at the beginning and end of the academic year . This test consisted of two pairs of articles on therapy for acute lung injury . For the pretest , each fellow was assigned , at r and om , one pair of articles . Fellows were given 1 hr to review both articles and to fill out a six-point test to assess their ability and confidence to appraise each article . At the end of the year , each fellow was tested on the opposite pair , the tests were grade d in a blinded fashion and the results of each test were compared . Six fellows completed both pre- and posttests . These paired results were analyzed separately , whereas results for another six fellows were conducted as an unpaired analysis . Mean scores increased both for the paired analysis ( 4.1 ± 0.7 vs. 5.1 ± 0.5;p = .015 ) and for the unpaired analysis ( 4.3 ± 0.6 vs. 5.0 ± 0.5;p = .012 ) . Self-reported confidence in critical appraisal also increased ( 2.5 ± 0.5 vs. 3.9 ± 0.7;p = .004 and 2.6 ± 0.5 vs. 3.9 ± 0.6;p < .001 , respectively ) . Conclusion Critical appraisal exercises used in the training of critical care medicine fellows appear to improve both ability and confidence to appraise relevant medical literature Introduction Critical appraisal skills are believed to play a central role in an evidence -based approach to health practice . The aim of this study was to evaluate the effectiveness and costs of a critical appraisal skills educational intervention aim ed at health care professionals . Methods This prospect i ve controlled trial r and omized 145 self-selected general practitioners , hospital physicians , professions allied to medicine , and healthcare managers/administrators from the South West of Engl and to a half-day critical appraisal skills training workshop ( based on the model of problem-based small group learning ) or waiting list control . The following outcomes were assessed at 6-months follow up : knowledge of the principles necessary for appraising evidence ; attitudes towards the use of evidence about healthcare ; evidence seeking behaviour ; perceived confidence in appraising evidence ; and ability to critically appraise a systematic review article . Results At follow up overall knowledge score [ mean difference : 2.6 ( 95 % CI : 0.6 to 4.6 ) ] and ability to appraise the results of a systematic review [ mean difference : 1.2 ( 95 % CI : 0.01 to 2.4 ) ] were higher in the critical skills training group compared to control . No statistical significant differences in overall attitude towards evidence , evidence seeking behaviour , perceived confidence , and other areas of critical appraisal skills ability ( methodology or generalizability ) were observed between groups . Taking into account the workshop provision costs and costs of participants time and expenses of participants , the average cost of providing the critical appraisal workshops was approximately £ 250 per person . Conclusions The findings of this study challenge the policy of funding ' one-off ' educational interventions aim ed at enhancing the evidence -based practice of health care professionals . Future evaluations of evidence -based practice interventions need to take in account this trial 's negative findings and method ological difficulties Background The specificity of clinical questions is gauged by explicit descriptions of four dimensions : subjects , interventions , comparators and outcomes of interest . This study determined whether adding simple instructions and examples on clinical question formulation would increase the specificity of the su bmi tted question compared to using a st and ard form without instructions and examples . Methods A r and omised controlled trial was conducted in an evidence - search and appraisal service . New participants were invited to reformulate clinical queries . The Control Group was given no instructions . The Intervention Group was given a brief explanation of proper formulation , written instructions , and diagrammatic examples . The primary outcome was the change in the proportion of reformulated questions that described each the dimensions of specificity . Results Fifty-two subjects agreed to participate in the trial of which 13 were lost to follow-up . The remaining 17 Intervention Group and 22 Control Group participants were analysed . Baseline characteristics were comparable . Overall , 20 % of initially su bmi tted questions from both groups were properly specified ( defined as an explicit statement describing all dimensions of specificity ) . On follow-up , 7/14 questions previously rated as mis-specified in the Intervention Group had all dimensions described at follow-up ( p = 0.008 ) while the Control Group did not show any changes from baseline . Participants in the Intervention Group were also more likely to explicitly describe patients ( p = 0.028 ) , comparisons ( p = 0.014 ) , and outcomes ( p = 0.008 ) . Conclusions This trial demonstrated the positive impact of specific instructions on the proportion of properly-specified clinical queries . The evaluation of the long-term impact of such changes is an area of continued research A double-blind r and omised controlled trial was conducted on a group of Hong Kong hospital clinicians . The objective was to test if a three-hour educational workshop ( with supervised h and s-on practice ) is more effective ( than no training ) to improve clinical question formulation , information-seeking skills , knowledge , attitudes , and search outcomes . The design was a post-test-only control group ; recruitment by stratified r and omization ( by profession ) , blocked at 800 . End-user training was more effective than no training in improving clinical question formulation , in raising awareness , knowledge , confidence and use of data bases , but had made no impact on preference for secondary data bases . It changed the attitude of clinicians to become more positive towards the use of electronic information services ( EIS ) . Participants had higher search performance and outcomes ( satisfaction with information obtained ( NNT = 3 ) , EIS satisfaction ( NNT = 3 ) and success in problem solving ( NNT = 4 ) ) . The workshop improved knowledge and skills in evidence -based search ing , but this effect gradually eroded with time . Search logs confirmed that follow-up is required if effects are to be sustained . Longer effects on search behaviours appear to be positive . A r and omised controlled trial is valuable in identifying cause- and -effect relations and to quantify the magnitude of the effects for management decision-making STUDY OBJECTIVES To compare the performance of an evidence -based medicine ( EBM ) approach and a traditional approach to teaching critical appraisal skills to emergency medicine residents . METHODS This was a prospect i ve , case-controlled trial of 32 emergency medicine residents ( 16 control and 16 intervention ) . Intervention residents were exposed to a monthly , 1-hour journal club using an EBM approach to critical appraisal over the course of 1 year . Control residents were exposed to a traditional , unstructured journal club , also monthly . Both groups were given a factitious article to evaluate in an essay format before and after the 12-month study period . The Wilcoxon rank sum test was used to compare mean improvement in test scores for each group . RESULTS The mean improvement in test scores was 1.80 for the control group and 1.53 for the intervention group ; these values were not significantly different ( P = .90 ) . The difference in mean change in test score between the 2 groups was.27 points . CONCLUSION Compared with a traditional approach , an EBM approach to teaching critical appraisal did not appear to improve the critical appraisal skills of emergency medicine residents . However , because of the small number of subjects studied , small differences in critical appraisal skill improvement can not be ruled out Purpose . To measure the impact of a resident focused evidence -based medicine ( EBM ) educational intervention on EBM knowledge of residents and students , to assess its feasibility , and to evaluate residents ’ attitudes regarding this rotation . Method . In 2002 , based on the EBM user and EBM practitioner model , the authors design ed the EBM elective rotation and conducted a controlled trial of its implementation in the internal medicine residency program in three teaching hospitals affiliated with the University at Buffalo , New York . The intervention group ( one hospital , 17 medical students and residents ) received a multifaceted intervention . In the control group ( two hospitals , 23 medical students and residents ) , there was no curriculum change . The effectiveness in a pre- and posttest was assessed using the English version of the Berlin Question naire . A survey of all internal medicine residents ( n = 119 ) was conducted to evaluate their attitudes toward the EBM elective rotation . Results . In the intervention group , knowledge improved slightly , but not significantly ( .71 on a scale ranging from 0–15 on the Berlin question naire , p = .3 ) . The mean score in the control group decreased significantly ( 1.65 , p = .005 ) . The difference in change scores between the two groups was significant even after adjustment for covariates ( 2.52 , p = .006 ) . Residents ( response rate 83 % ) had positive attitudes regarding the rotation . Conclusion . An EBM elective rotation was successfully integrated into a residency program . This multifaceted educational approach with an “ on-the-ward ” EBM resident , may improve the EBM knowledge and skills of targeted students and residents OBJECTIVES To measure the effectiveness of an educational intervention design ed to teach residents four essential evidence -based medicine ( EBM ) skills : question formulation , literature search ing , underst and ing quantitative outcomes , and critical appraisal . DESIGN Firm-based , controlled trial . SETTING Urban public hospital . PARTICIPANTS Fifty-five first-year internal medicine residents : 18 in the experimental group and 37 in the control group . INTERVENTION An EBM course , taught 2 hours per week for 7 consecutive weeks by senior faculty and chief residents focusing on the four essential EBM skills . MEASUREMENTS AND MAIN RESULTS The main outcome measure was performance on an EBM skills test that was administered four times over 11 months : at baseline and at three time points postcourse . Postcourse test 1 assessed the effectiveness of the intervention in the experimental group ( primary outcome ] ; postcourse test 2 assessed the control group after it crossed over to receive the intervention ; and postcourse test 3 assessed durability . Baseline EBM skills were similar in the two groups . After receiving the EBM course , the experimental group achieved significantly higher postcourse test scores ( adjusted mean difference , 21 % ; 95 % confidence interval , 13 % to 28 % ; P < .001 ) . Postcourse improvements were noted in three of the four EBM skill domains ( formulating questions , search ing , and quantitative underst and ing [ P < .005 for all ] , but not in critical appraisal skills [ P = .4 ] ) . After crossing over to receive the educational intervention , the control group achieved similar improvements . Both groups sustained these improvements over 6 to 9 months of follow-up . CONCLUSIONS A brief structured educational intervention produced substantial and durable improvements in residents ' cognitive and technical EBM skills BACKGROUND The effectiveness of interventions for developing critical appraisal skills in practicing physicians has not been studied , despite the documented importance of reading the literature in caring for patients and in continuing professional development . The objective of this study was to evaluate whether an Internet-based intervention would lead to enhanced critical appraisal skills in practicing surgeons . METHODS General surgeons who agreed to participate were r and omized into 2 groups . The intervention was a curriculum in critical appraisal skills that included a clinical and method ologic article , a listserve discussion , and clinical and method ologic critiques . The control group received only the clinical articles . The primary outcome measure was a previously vali date d 2-hour test of critical appraisal . RESULTS Of the 55 surgeons who completed the examination , subjects in the intervention group performed better on the test of critical appraisal skills than those in the control group ( mean score : intervention group , 58 % + /- 8 vs control group , 50 % + /- 8) , with a large effect size of 1.06 st and ard deviation units ( t+3.92 , P < .0001 ) . Training conditions accounted for 22 % of the variance in total scores . CONCLUSIONS A multifaceted , Internet-based intervention result ed in improved critical appraisal skills of practicing general surgeons Abstract OBJECTIVE : Previous studies have shown that most medical in patients receive treatment supported by strong evidence ( evidence -based treatment ) , but they have not assessed whether and how physicians actually use evidence when making their treatment decisions . We investigated whether physicians would change inpatient treatment if presented with the results of a literature search . DESIGN : Before-after study . SETTING : Large public teaching hospital . PARTICIPANTS : R and om sample of 146 in patients cared for by 33 internal medicine attending physicians . INTERVENTIONS : After physicians committed to a specific diagnosis and treatment plan , investigators performed st and ardized literature search es and provided the search results to the attending physicians . MEASUREMENTS AND MAIN RESULTS : The primary study outcome was the number of patients whose attending physicians would change treatment due to the literature search es . These changes were evaluated by blinded peer review . A secondary outcome was the proportion of patients who received evidence -based treatment before and after the literature search es . Attending physicians changed treatment for 23 ( 18 % ) of 130 eligible patients ( 95 % confidence interval , 12 % to 24 % ) as a result of the literature search es . Overall , 86 % of patients ( 112 of 130 ) received evidence -based treatments before the search es and 87 % ( 113 of 130 ) after the search es . Changes were not related to whether patients were receiving evidence -based treatment before the search ( P=.6 ) . Panels of peer review ers judged the quality of patient care as improved or maintained for 18 ( 78 % ) of the 23 patients with treatment changes . CONCLUSIONS : Search ing the literature could improve the treatment of many medical in patients , including those already receiving evidence -based treatment BACKGROUND Physician adherence to guidelines is often poor , but the reasons have not been completely studied . We investigated whether physician adherence to guidelines for percutaneous transluminal coronary angioplasty ( PTCA ) and coronary artery bypass grafting ( CABG ) varied by source , development methods , or the extent of their evidence -base . METHODS AND RESULTS We assessed adherence to guidelines developed by the American College of Cardiology/American Heart Association ( ACC/AHA ) for PTCA ( 1988 and 1993 ) and for CABG ( 1990 ) and guidelines developed by R AND for PTCA and CABG in 1990 . We r and omly sample d patients on Medicare who were undergoing coronary angiography in 5 states in 1991 and 1992 , extracting clinical and laboratory data from medical records and using computer programs to classify the appropriateness of each procedure . A total of 543 PTCA and 676 CABG procedures were studied . By use of the 1988 ACC/AHA guidelines , 30 % of PTCAs were rated class III ( inappropriate ) , whereas 24 % were class III by use of the 1993 guidelines . Only 1.5 % of CABG procedures were class III with ACC/AHA guidelines . By use of R AND guidelines , 12 % of PTCA and 9 % of CABG procedures were classified as inappropriate . CONCLUSIONS Adherence to guidelines is higher when the recommendations are supported by evidence from r and omized clinical trials ( CABG ) . The credibility of the source and familiarity with the guidelines do not ensure compliance . When evidence is lacking , as with PTCA at the time of this study , guideline recommendations may lag behind appropriate changes in clinical practice . More frequent revisions coupled with on-line access have the potential to make guidelines more useful OBJECTIVE To examine the evidence that the teaching of critical appraisal ( evidence -based medicine ) skills to undergraduate medical students or residents will result in significant gains in knowledge and increased use of the literature in clinical decision-making . DATA SOURCES Articles published from 1966 to 1995 , retrieved through a MEDLINE search supplemented by manual search es ; review of bibliographies maintained by individuals involved in teaching critical appraisal skills ; and a previous method ological review . STUDY SELECTION Articles were selected if the study involved some form of control group , although strict r and omization was not required , and a measure of performance followed the intervention . Articles were excluded if they simply reported the process of teaching critical appraisal skills or used some form of " happiness index . " DATA SYNTHESIS There were 10 studies of the impact of teaching critical appraisal skills , 6 involving medical students and 4 involving residents . Results from 3 of the studies were nearly uninterpretable and thus were excluded ; the remaining 7 were method ologically acceptable . Analysis showed that interventions implemented in undergraduate programs result ed in significant gains in knowledge , as assessed by a written test ( mean gain 17.0 % ; st and ard deviation [ SD ] 4.0 % ) . Conversely , studies at the residency level consistently showed a small change in knowledge ( mean gain 1.3 % ; SD 1.7 % ) . Two studies that examined residents ' use of the literature were unable to demonstrate any positive changes . CONCLUSIONS Studies of the effect of teaching critical appraisal skills on gains in knowledge at the undergraduate level showed consistent improvement . By contrast , changes in knowledge at the residency level were small . Several suggestions from the educational literature are offered to increase effectiveness of critical appraisal interventions AN INCREASING NUMBER OF MEDICAL SCHOOLS AND residency programs are instituting curricula for teaching the principles and practice of evidence based medicine ( EBM ) . For example , 95 % of US internal medicine residency programs have journal clubs and 37 % of US and Canadian internal medicine residencies have time dedicated for EBM . Curricula based on EBM are increasingly popular in residency programs in other specialties , including family medicine , pediatrics , obstetrics/ gynecology , and surgery . Despite the widespread teaching of EBM , however , most of what is known about the outcomes of evidence -based curricula relies on observational data . Although evaluation of the quality of research evidence is a core competency of EBM , the quantity and quality of the evidence for effectively teaching EBM are poor . Ironically , if one were to develop guidelines for how to teach EBM based on these results , they would be based on the lowest level of evidence . There are several reasons why the quality of the evidence for teaching EBM is so weak . Many of these problems are related to the limitations in educational research in general . First , quantitative research methods may be inadequate to capture the complexity of an educational system . Second , students and residents change frequently , making it difficult to retain a consistent sample . Third , the time allotted for a given intervention may be brief in the context of the overall medical curriculum . Fourth , educational institutions may be hesitant to pay students as research participants or to allocate them to unproved educational interventions . Fifth , because most educational interventions are unique to specific institutions , assessment of their effectiveness is usually limited by small sample sizes . Furthermore , even if such interventions could be instituted across multiple institutions , the problems of st and ardization and cointervention would be particularly challenging . Sixth , perhaps because they are simplest to measure , the most frequently reported outcomes are subjective variables such as satisfaction or self-reported changes in attitudes or knowledge , rather than more important assessment s of objective ly measured clinical skills or improved patient outcomes . Finally , granting agencies do not give priority to educational investigations , making it difficult to undertake definitive multicenter studies . Educators who have struggled to evaluate educational interventions will find these issues all too familiar . With the increasing prevalence of EBM teaching , however , high quality evidence is more important than ever . Assessment of EBM teaching has also presented some unique problems . For instance , we originally defined evidence -based practice in terms of 4 basic competencies : ( 1 ) recognition of a patient problem and construction of a structured clinical question ; ( 2 ) ability to efficiently and effectively search the medical literature to retrieve the best available evidence to answer the clinical question ; ( 3 ) critical appraisal of the evidence ; and ( 4 ) integration of the evidence with all aspects of individual patient decision making to determine the best clinical care for the patient . Although these 4 skills were the most commonly reported curricular objectives in 99 internal medicine residencies that teach EBM , almost all the research on EBM education has focused exclusively on the third item : teaching critical appraisal skills . Examining this literature may yield useful insights into the difficulties of EBM educational research . Since critical appraisal skills involve the ability to differentiate strong from weak research methods , one might expect that this research would be of relatively high quality . In fact , most of these studies are method ologically weak . Using broad criteria to identify any reports of a graduate ( residency ) EBM curricula , Green identified 18 reports published between 1980 and 1997 . Of these , 72 % used a traditional journal club format to teach critical appraisal skills . Only 7 of the 18 studies evaluated the effectiveness of their intervention . Five of these 7 studies compared intervention with control ( only 1 with r and omized design ) ; only 2 of 7 studies used any blinding . Of these 5 controlled studies , 2 used a vali date d outcome measure to evaluate critical appraisal skills . Measurement of behavioral change relied on self-report in all 5 studies , and none examined patient outcomes . Most reports did not evaluate their PURPOSE To test whether an academic detailing intervention would improve journal reading among residents . METHOD In 1995 - 96 , the authors conducted a r and omized controlled trial at two family medicine residencies in Missouri . Fifty-nine family practice residents were r and omized into two groups identical in baseline characteristics ; 29 received individual 15-minute educational presentations , based on academic detailing , that emphasized careful selection of medical journal articles for reading . The authors measured the percentage of important journal articles of which the residents were aware , the percentage of those they had read ( either abstract only or the whole article ) , and the percentage of correctly answered knowledge questions . RESULTS Despite r and omization , the residents in the control group indicated on the pretest that they were more likely than were the residents in the intervention group to be aware of and to have read abstract s from selected articles . However , when comparing pretest with posttest results , the intervention group recalled 18.2 % ( 95 % CI , 2.0 , 34.0 ) more articles and correctly answered 16.6 % ( 95 % CI 3.0 , 29.9 ) more knowledge questions than did the control group . CONCLUSION A brief intervention increased residents ' recall of important articles and knowledge of those articles ' conclusions Purpose To investigate whether teaching an evidence -based medicine ( EBM ) curriculum increased the knowledge and use of EBM principles in residents ' continuity clinics . Method In 1999 , the authors performed a needs assessment with residents and faculty of Cascades East Family Practice Residency in Oregon and constructed a ten-session EBM workshop series that was introduced into the curriculum in 2000 . Resident – preceptor interactions during outpatient continuity clinic were tape-recorded prior to and six months following introduction of the curriculum . A 50-item , multiple-choice examination was administered before and after the workshop series . Residents at another FP residency at the same university served as a control group . The same assessment s were applied to the experimental and control groups . The tape recordings were analyzed for interactions that contained key EBM phrases or words . Results Pre-intervention multiple-choice test results were similar ( control mean 56 % , experimental 53 % , p > .22 NS ) . Post-intervention test scores for the experimental group were significantly improved ( mean 72 % , p < .001 ) . There was no significant improvement in test results among members of the control group ( p > .05 NS ) . In the recorded resident – preceptor interactions , a marked increase in the use of EBM terms indicated awareness and /or use of EBM in the experimental group . In 1,165 minutes recorded prior to the workshops , EBM terms were used in a total of ten events . In 735 minutes recorded after the workshops , EBM terms were recorded in 67 events . A reduced number of EBM terms were recorded in the control group . Conclusion Administering a structured EBM curriculum increased residents ' knowledge and use of EBM constructs during patient care The journal club is an established teaching modality in many house-staff training programs . To determine if a journal club improves house-staff reading habits , knowledge of epidemiology and biostatistics , and critical appraisal skills , we r and omized 44 medical interns to receive either a journal club or a control seminar series . A test instrument developed by the Delphi method was administered before and after the interventions ( mean , five journal club sessions ) . By self-report , 86 % of the house staff in the journal club group improved their reading habits vs 0 % in the control group . Knowledge scores increased more in the journal club group than in the control group , and a trend was found toward more knowledge gained as more sessions were attended . Ability to appraise critically a test article increased slightly in each group , but there was no significant difference between the groups . We conclude that a journal club is a powerful motivator of critical house-staff reading behavior and can help teach epidemiology and biostatistics to physicians-in-training |
1,319 | 24,495,312 | Sensitivity of PCVA versus hospital-assigned COD varied widely by cause , but showed consistently high specificity .
At the population level , the relative CSMF error between PCVA and hospital-based deaths indicated good performance for most CODs .
R and om Forest had the best CSMF accuracy performance , followed closely by PCVA and the other CCVA methods , but with lower values for InterVA-3 .
Conclusions There is no single best-performing coding method for verbal autopsies across various studies and metrics .
There is little current justification for CCVA to replace PCVA , particularly as physician diagnosis remains the worldwide st and ard for clinical diagnosis on live patients . | Background Computer-coded verbal autopsy ( CCVA ) methods to assign causes of death ( CODs ) for medically unattended deaths have been proposed as an alternative to physician-certified verbal autopsy ( PCVA ) . | BACKGROUND The age-specific mortality rates and total deaths from specific cancers have not been documented for the various regions and sub population s of India . We therefore assessed the cause of death in 2001 - 03 in homes in small areas that were chosen to be representative of all the parts of India . METHODS At least 130 trained physicians independently assigned causes to 122,429 deaths , which occurred in 1·1 million homes in 6671 small areas that were r and omly selected to be representative of all of India , based on a structured non-medical surveyor 's field report . FINDINGS 7137 of 122,429 study deaths were due to cancer , corresponding to 556,400 national cancer deaths in India in 2010 . 395,400 ( 71 % ) cancer deaths occurred in people aged 30 - 69 years ( 200,100 men and 195,300 women ) . At 30 - 69 years , the three most common fatal cancers were oral ( including lip and pharynx , 45,800 [ 22·9 % ] ) , stomach ( 25,200 [ 12·6 % ] ) , and lung ( including trachea and larynx , 22,900 [ 11·4 % ] ) in men , and cervical ( 33,400 [ 17·1 % ] ) , stomach ( 27,500 [ 14·1 % ] ) , and breast ( 19,900 [ 10·2 % ] ) in women . Tobacco-related cancers represented 42·0 % ( 84,000 ) of male and 18·3 % ( 35,700 ) of female cancer deaths and there were twice as many deaths from oral cancers as lung cancers . Age-st and ardised cancer mortality rates per 100,000 were similar in rural ( men 95·6 [ 99 % CI 89·6 - 101·7 ] and women 96·6 [ 90·7 - 102·6 ] ) and urban areas ( men 102·4 [ 92·7 - 112·1 ] and women 91·2 [ 81·9 - 100·5 ] ) , but varied greatly between the states , and were two times higher in the least educated than in the most educated adults ( men , illiterate 106·6 [ 97·4 - 115·7 ] vs most educated 45·7 [ 37·8 - 53·6 ] ; women , illiterate 106·7 [ 99·9 - 113·6 ] vs most educated 43·4 [ 30·7 - 56·1 ] ) . Cervical cancer was far less common in Muslim than in Hindu women ( study deaths 24 , age-st and ardised mortality ratio 0·68 [ 0·64 - 0·71 ] vs 340 , 1·06 [ 1·05 - 1·08 ] ) . INTERPRETATION Prevention of tobacco-related and cervical cancers and earlier detection of treatable cancers would reduce cancer deaths in India , particularly in the rural areas that are underserved by cancer services . The substantial variation in cancer rates in India suggests other risk factors or causative agents that remain to be discovered . FUNDING Bill & Melinda Gates Foundation and US National Institutes of Health BACKGROUND National malaria death rates are difficult to assess because reliably diagnosed malaria is likely to be cured , and deaths in the community from undiagnosed malaria could be misattributed in retrospective enquiries to other febrile causes of death , or vice-versa . We aim ed to estimate plausible ranges of malaria mortality in India , the most populous country where the disease remains common . METHODS Full-time non-medical field workers interviewed families or other respondents about each of 122,000 deaths during 2001 - 03 in 6671 r and omly selected areas of India , obtaining a half-page narrative plus answers to specific questions about the severity and course of any fevers . Each field report was sent to two of 130 trained physicians , who independently coded underlying causes , with discrepancies resolved either via anonymous reconciliation or adjudication . FINDINGS Of all coded deaths at ages 1 month to 70 years , 2681 ( 3·6 % ) of 75,342 were attributed to malaria . Of these , 2419 ( 90 % ) were in rural areas and 2311 ( 86 % ) were not in any health-care facility . Death rates attributed to malaria correlated geographically with local malaria transmission ratesderived independently from the Indian malaria control programme . The adjudicated results show 205,000 malaria deaths per year in India before age 70 years ( 55,000 in early childhood , 30,000 at ages 5 - 14 years , 120,000 at ages 15 - 69 years ) ; 1·8 % cumulative probability of death from malaria before age 70 years . Plausible lower and upper bounds ( on the basis of only the initial coding ) were 125,000 - 277,000 . Malaria accounted for a substantial minority of about 1·3 million unattended rural fever deaths attributed to infectious diseases in people younger than 70 years . INTERPRETATION Despite uncertainty as to which unattended febrile deaths are from malaria , even the lower bound greatly exceeds the WHO estimate of only 15,000 malaria deaths per year in India ( 5000 early childhood , 10 000 thereafter ) . This low estimate should be reconsidered , as should the low WHO estimate of adult malaria deaths worldwide . FUNDING US National Institutes of Health , Canadian Institute of Health Research , Li Ka Shing Knowledge Institute Background Physician-coded verbal autopsy ( PCVA ) is the most widely used method to determine causes of death ( CODs ) in countries where medical certification of death is uncommon . Computer-coded verbal autopsy ( CCVA ) methods have been proposed as a faster and cheaper alternative to PCVA , though they have not been widely compared to PCVA or to each other . Methods We compared the performance of open- source r and om forest , open- source tariff method , InterVA-4 , and the King-Lu method to PCVA on five data sets comprising over 24,000 verbal autopsies from low- and middle-income countries . Metrics to assess performance were positive predictive value and partial chance-corrected concordance at the individual level , and cause-specific mortality fraction accuracy and cause-specific mortality fraction error at the population level . Results The positive predictive value for the most probable COD predicted by the four CCVA methods averaged about 43 % to 44 % across the data sets . The average positive predictive value improved for the top three most probable CODs , with greater improvements for open- source r and om forest ( 69 % ) and open- source tariff method ( 68 % ) than for InterVA-4 ( 62 % ) . The average partial chance-corrected concordance for the most probable COD predicted by the open- source r and om forest , open- source tariff method and InterVA-4 were 41 % , 40 % and 41 % , respectively , with better results for the top three most probable CODs . Performance generally improved with larger data sets . At the population level , the King-Lu method had the highest average cause-specific mortality fraction accuracy across all five data sets ( 91 % ) , followed by InterVA-4 ( 72 % across three data sets ) , open- source r and om forest ( 71 % ) and open- source tariff method ( 54 % ) . Conclusions On an individual level , no single method was able to replicate the physician assignment of COD more than about half the time . At the population level , the King-Lu method was the best method to estimate cause-specific mortality fractions , though it does not assign individual CODs . Future testing should focus on combining different computer-coded verbal autopsy tools , paired with PCVA strengths . This includes using open- source tools applied to larger and varied data sets ( especially those including a r and om sample of deaths drawn from the population ) , so as to establish the performance for age- and sex-specific CODs Background Computer-coded verbal autopsy ( CCVA ) is a promising alternative to the st and ard approach of physician-certified verbal autopsy ( PCVA ) , because of its high speed , low cost , and reliability . This study introduces a new CCVA technique and vali date s its performance using defined clinical diagnostic criteria as a gold st and ard for a multisite sample of 12,542 verbal autopsies ( VAs ) . Methods The R and om Forest ( RF ) Method from machine learning ( ML ) was adapted to predict cause of death by training r and om forests to distinguish between each pair of causes , and then combining the results through a novel ranking technique . We assessed quality of the new method at the individual level using chance-corrected concordance and at the population level using cause-specific mortality fraction ( CSMF ) accuracy as well as linear regression . We also compared the quality of RF to PCVA for all of these metrics . We performed this analysis separately for adult , child , and neonatal VAs . We also assessed the variation in performance with and without household recall of health care experience ( HCE ) . Results For all metrics , for all setting s , RF was as good as or better than PCVA , with the exception of a nonsignificantly lower CSMF accuracy for neonates with HCE information . With HCE , the chance-corrected concordance of RF was 3.4 percentage points higher for adults , 3.2 percentage points higher for children , and 1.6 percentage points higher for neonates . The CSMF accuracy was 0.097 higher for adults , 0.097 higher for children , and 0.007 lower for neonates . Without HCE , the chance-corrected concordance of RF was 8.1 percentage points higher than PCVA for adults , 10.2 percentage points higher for children , and 5.9 percentage points higher for neonates . The CSMF accuracy was higher for RF by 0.102 for adults , 0.131 for children , and 0.025 for neonates . Conclusions We found that our RF Method outperformed the PCVA method in terms of chance-corrected concordance and CSMF accuracy for adult and child VA with and without HCE and for neonatal VA without HCE . It is also preferable to PCVA in terms of time and cost . Therefore , we recommend it as the technique of choice for analyzing past and current verbal autopsies Background Physician review of a verbal autopsy ( VA ) and completion of a death certificate remains the most widely used approach for VA analysis . This study provides new evidence about the performance of physician-certified verbal autopsy ( PCVA ) using defined clinical diagnostic criteria as a gold st and ard for a multisite sample of 12,542 VAs . The study was also design ed to analyze issues related to PCVA , such as the impact of a second physician reader on the cause of death assigned , the variation in performance with and without household recall of health care experience ( HCE ) , and the importance of local information for physicians reading VAs . Methods The certification was performed by 24 physicians . The assignment of VA was r and om and blinded . Each VA was certified by one physician . Half of the VAs were review ed by a different physician with household recall of health care experience included . The completed death certificate was processed for automated ICD-10 coding of the underlying cause of death . PCVA was compared to gold st and ard cause of death assignment based on strictly defined clinical diagnostic criteria that are part of the Population Health Metrics Research Consortium ( PHMRC ) gold st and ard verbal autopsy study . Results For individual cause assignment , the overall chance-corrected concordance for PCVA against the gold st and ard cause of death is less than 50 % , with substantial variability by cause and physician . Physicians assign the correct cause around 30 % of the time without HCE , and addition of HCE improves performance in adults to 45 % and slightly higher in children to 48 % . Physicians estimate cause-specific mortality fractions ( CSMFs ) with considerable error for adults , children , and neonates . Only for neonates for a cause list of six causes with HCE is accuracy above 0.7 . In all three age groups , CSMF accuracy improves when household recall of health care experience is available . Conclusions Results show that physician coding for cause of death assignment may not be as robust as previously thought . The time and cost required to initially collect the verbal autopsies must be considered in addition to the analysis , as well as the impact of diverting physicians from servicing immediate health needs in a population to review VAs . All of these considerations highlight the importance and urgency of developing better methods to more reliably analyze past and future verbal autopsies to obtain the highest quality mortality data from population s without reliable death certification Background Verbal autopsy is important for detecting causes of death including HIV in areas with inadequate vital registration systems . Before antiretroviral therapy ( ART ) introduction , a verbal autopsy study in rural Ug and a found that half of adult deaths assessed were in HIV-positive individuals . We used verbal autopsy to compare the proportion of HIV-positive adult deaths in the periods before and after ART introduction . Methods Between 2006 and 2008 , all adult ( ≥ 13 years ) deaths in a prospect i ve population -based cohort study were identified by monthly death registration , and HIV serostatus was determined through annual serosurveys . A clinical officer interviewed a relative of the deceased using a verbal autopsy question naire . Two clinicians independently review ed the question naires and classified the deaths as HIV-positive or not . A third clinician was the tie-breaker in case of nonagreement . The performance of the verbal autopsy tool was assessed using HIV serostatus as the gold st and ard of comparison . We compared the proportions of HIV-positive deaths as assessed by verbal autopsy in the early 1990s and the 2006 - 2008 periods . Results Of 333 deaths among 12,641 adults of known HIV serostatus , 264 ( 79.3 % ) were assessed by verbal autopsy , of whom 59 ( 22.3 % ) were HIV-seropositive and 68 ( 25.8 % ) were classified as HIV-positive by verbal autopsy . Verbal autopsy had a specificity of 90.2 % and positive predictive value of 70.6 % for identifying deaths among HIV-infected individuals , with substantial interobserver agreement ( 80.3 % ; kappa statistic = 0.69 ) . The HIV-attributable mortality fraction estimated by verbal autopsy decreased from 47.0 % ( pre-ART period ) to 25.8 % ( ART period ) , p < 0.001 . Conclusions In re source -limited setting s , verbal autopsy can provide a good estimate of the prevalence of HIV infection among adult deaths . In this rural population , the proportion of deaths identified by verbal autopsy as HIV-positive declined between the early 1990s and the 2006 - 2008 period . Verbal autopsy findings can inform policy on HIV health care needs Background Verbal autopsy ( VA ) has been proposed to determine the cause of death ( COD ) distributions in setting s where most deaths occur without medical attention or certification . We develop performance criteria for VA-based COD systems and apply these to the Registrar General of India ’s ongoing , nationally-representative Indian Million Death Study ( MDS ) . Methods Performance criteria include a low ill-defined proportion of deaths before old age ; reproducibility , including consistency of COD distributions with independent resampling ; differences in COD distribution of hospital , home , urban or rural deaths ; age- , sex- and time-specific plausibility of specific diseases ; stability and repeatability of dual physician coding ; and the ability of the mortality classification system to capture a wide range of conditions . Results The introduction of the MDS in India reduced the proportion of ill-defined deaths before age 70 years from 13 % to 4 % . The cause-specific mortality fractions ( CSMFs ) at ages 5 to 69 years for independently re sample d deaths and the MDS were very similar across 19 disease categories . By contrast , CSMFs at these ages differed between hospital and home deaths and between urban and rural deaths . Thus , reliance mostly on urban or hospital data can distort national estimates of CODs . Age- , sex- and time-specific patterns for various diseases were plausible . Initial physician agreement on COD occurred about two-thirds of the time . The MDS COD classification system was able to capture more eligible records than alternative classification systems . By these metrics , the Indian MDS performs well for deaths prior to age 70 years . The key implication for low- and middle-income countries where medical certification of death remains uncommon is to implement COD surveys that r and omly sample all deaths , use simple but high- quality field work with built-in resampling , and use electronic rather than paper systems to expedite field work and coding . Conclusions Simple criteria can evaluate the performance of VA-based COD systems . Despite the misclassification of VA , the MDS demonstrates that national surveys of CODs using VA are an order of magnitude better than the limited COD data previously available Background Over 75 % of the annual estimated 9.5 million deaths in India occur in the home , and the large majority of these do not have a certified cause . India and other developing countries urgently need reliable quantification of the causes of death . They also need better epidemiological evidence about the relevance of physical ( such as blood pressure and obesity ) , behavioral ( such as smoking , alcohol , HIV-1 risk taking , and immunization history ) , and biological ( such as blood lipids and gene polymorphisms ) measurements to the development of disease in individuals or disease rates in population s. We report here on the rationale , design , and implementation of the world 's largest prospect i ve study of the causes and correlates of mortality . Methods and Findings We will monitor nearly 14 million people in 2.4 million nationally representative Indian households ( 6.3 million people in 1.1 million households in the 1998–2003 sample frame and 7.6 million people in 1.3 million households in the 2004–2014 sample frame ) for vital status and , if dead , the causes of death through a well-vali date d verbal autopsy ( VA ) instrument . About 300,000 deaths from 1998–2003 and some 700,000 deaths from 2004–2014 are expected ; of these about 850,000 will be coded by two physicians to provide causes of death by gender , age , socioeconomic status , and geographical region . Pilot studies will evaluate the addition of physical and biological measurements , specifically dried blood spots . Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death , reduce the misclassification of causes , and derive the probable underlying cause of death when it has not been reported . VA yields broad classification of the underlying causes in about 90 % of deaths before age 70 . In old age , however , the proportion of classifiable deaths is lower . By tracking underlying demographic denominators , the study permits quantification of absolute mortality rates . Household case-control , proportional mortality , and nested case-control methods permit quantification of risk factors . Conclusions This study will reliably document not only the underlying cause of child and adult deaths but also key risk factors ( behavioral , physical , environmental , and eventually , genetic ) . It offers a globally replicable model for reliably estimating cause-specific mortality using VA and strengthens India 's flagship mortality monitoring system . Despite the misclassification that is still expected , the new cause-of-death data will be substantially better than that available previously Background Registration of the fact of death is almost complete in the city of Chennai and not so in the rural Villupuram district in Tamilnadu , India . The cause of death is often inadequately recorded on the death certificate in developing countries like India . A special verbal autopsy ( VA ) study of 48 000 adult ( aged ≥ 25 yrs ) deaths in the city of Chennai ( urban ) during 1995–97 and 32 000 in rural Villupuram during 1997–98 was conducted to arrive at the probable underlying cause of death to estimate cause specific mortality . Methods A ten day training on writing verbal autopsy ( VA ) report for adult deaths was given to non-medical graduates with at least 15 years of formal education . They interviewed surviving spouse/close associates of the deceased to write a verbal autopsy report in local language ( Tamil ) on the complaints , symptoms , signs , duration and treatment details of illness prior to death . Each report was review ed central ly by two physicians independently . R and om re-interviewing of 5 % of the VA reports was done to check the reliability and reproducibility of the VA report . The validity of VA diagnosis was assessed only for cancer deaths . Results Verbal autopsy reduced the proportion of deaths attributed to unspecified and unknown causes from 54 % to 23 % ( p < 0.0001 ) in urban and from 41 % to 26 % ( p < 0.0001 ) in rural areas in Tamilnadu for adult deaths ( ≥ 25 ) . The sensitivity of VA to identify cancer was 95 % in the age group 25–69 . Conclusion A ten day training programme to write verbal autopsy report with adequate feed back sessions and r and om sampling of 5 % of the verbal autopsy reports for re-interview worked very well in Tamilnadu , to arrive at the probable underlying cause of death reliably for deaths in early adult life or middle age ( 25–69 years ) and less reliably for older ages ( 70 + ) . Thus VA is practicable for deaths in early adult life or middle age and is of more limited value in old age BACKGROUND Verbal autopsy ( VA ) has been widely used to ascertain causes of child deaths , but little is known about the usefulness of VA for adult deaths . This paper describes the process used to develop a VA tool for adult deaths and the results of a multicentre validation of this tool . METHODS A mortality classification was developed by including causes of death that might be arrived at by VAs and causes that are responsive to public health interventions . An algorithm was design ed for each cause in the classification , based on classifying symptoms into essential , supportive and differential . A structured question naire design ed to elicit information on these symptoms was developed in English translated into the local language s. The tool was vali date d on deaths occurring at hospitals in Tanzania ( 315 deaths ) , Ethiopia ( 249 ) and Ghana ( 232 ) . Hospital records of all adult deaths occurring at the study hospitals from June 1993 to April 1995 were collected prospect ively . Non-medical interviewers with at least 12 years of formal education conducted VA interviews . Causes of death were diagnosed by a panel of physicians and by a computerized algorithm . The validity of the VA was assessed by comparing the VA diagnoses with hospital diagnoses . RESULTS Specificity of VAs by physicians fell below 95 % only for acute febrile illness ( AFI ) and TB/AIDS . Sensitivity and positive predictive value ( PPV ) , however , varied widely both across the sites and between causes . Sensitivity was > 75 % for tetanus , rabies , direct maternal causes , injuries and TB/AIDS and ranged between 60 % and 74 % for diarrhoea , acute abdominal conditions and AFI . The PPV was > 75 % for tetanus , rabies , hepatitis and injuries and ranged between 60 and 74 % for meningitis , AFI , TB/AIDS and direct maternal causes . When the communicable diseases were combined in a single group , the sensitivity was 82 % , specificity 78 % and PPV 85 % . For the group of noncommunicable diseases the corresponding sensitivity , specificity and PPV were 71 % , 87 % and 67 % , respectively . Use of an algorithm result ed in lower sensitivity , specificity and PPV than the VAs by physician . CONCLUSION VAs by a panel of physicians performed better than an opinion-based algorithm . The validity of VA diagnosis was highest for AFI , direct maternal causes , TB/AIDS , tetanus , rabies and injuries Background InterVA is a widely disseminated tool for cause of death attribution using information from verbal autopsies . Several studies have attempted to vali date the concordance and accuracy of the tool , but the main limitation of these studies is that they compare cause of death as ascertained through hospital record review or hospital discharge diagnosis with the results of InterVA . This study provides a unique opportunity to assess the performance of InterVA compared to physician-certified verbal autopsies ( PCVA ) and alternative automated methods for analysis . Methods Using clinical diagnostic gold st and ards to select 12,542 verbal autopsy cases , we assessed the performance of InterVA on both an individual and population level and compared the results to PCVA , conducting analyses separately for adults , children , and neonates . Following the recommendation of Murray et al. , we r and omly varied the cause composition over 500 test data sets to underst and the performance of the tool in different setting s. We also contrasted InterVA with an alternative Bayesian method , Simplified Symptom Pattern ( SSP ) , to underst and the strengths and weaknesses of the tool . Results Across all age groups , InterVA performs worse than PCVA , both on an individual and population level . On an individual level , InterVA achieved a chance-corrected concordance of 24.2 % for adults , 24.9 % for children , and 6.3 % for neonates ( excluding free text , considering one cause selection ) . On a population level , InterVA achieved a cause-specific mortality fraction accuracy of 0.546 for adults , 0.504 for children , and 0.404 for neonates . The comparison to SSP revealed four specific characteristics that lead to superior performance of SSP . Increases in chance-corrected concordance are attained by developing cause-by-cause models ( 2 % ) , using all items as opposed to only the ones that mapped to InterVA items ( 7 % ) , assigning probabilities to clusters of symptoms ( 6 % ) , and using empirical as opposed to expert probabilities ( up to 8 % ) . Conclusions Given the widespread use of verbal autopsy for underst and ing the burden of disease and for setting health intervention priorities in areas that lack reliable vital registration s systems , accurate analysis of verbal autopsies is essential . While InterVA is an affordable and available mechanism for assigning causes of death using verbal autopsies , users should be aware of its suboptimal performance relative to other methods |
1,320 | 23,433,471 | Results The individual studies show that an inpatient geriatric consultation team intervention has favorable effects on functional status , readmission and mortality rate .
None of the studies found an effect on the length of the hospital stay .
Conclusions Inpatient geriatric consultation team interventions have a significant impact on mortality rate at 6 and 8 months postdischarge , but have no significant impact on functional status , readmission or length of stay .
The reason for the lack of effect on these latter outcomes may be due to insufficient statistical power or the insensitivity of the measuring method for , for example , functional status . | Abstract Background Comprehensive geriatric assessment for older patients admitted to dedicated wards has proven to be beneficial , but the impact of comprehensive geriatric assessment delivered by mobile inpatient geriatric consultation teams remains unclear .
This review and meta- analysis aims to determine the impact of inpatient geriatric consultation teams on clinical outcomes of interest in older adults . | Background : The hospital readmission rate has been proposed as an important outcome indicator computable from routine statistics . However , most commonly used measures raise conceptual issues . Objectives : We sought to evaluate the usefulness of the computerized algorithm for identifying avoidable readmissions on the basis of minimum bias , criterion validity , and measurement precision . Research Design and Subjects : A total of 131,809 hospitalizations of patients discharged alive from 49 hospitals were used to compare the predictive performance of risk adjustment methods . A subset of a r and om sample of 570 medical records of discharge/readmission pairs in 12 hospitals were review ed to estimate the predictive value of the screening of potentially avoidable readmissions . Measures : Potentially avoidable readmissions , defined as readmissions related to a condition of the previous hospitalization and not expected as part of a program of care and occurring within 30 days after the previous discharge , were identified by a computerized algorithm . Unavoidable readmissions were considered as censored events . Results : A total of 5.2 % of hospitalizations were followed by a potentially avoidable readmission , 17 % of them in a different hospital . The predictive value of the screen was 78 % ; 27 % of screened readmissions were judged clearly avoidable . The correlation between the hospital rate of clearly avoidable readmission and all readmissions rate , potentially avoidable readmissions rate or the ratio of observed to expected readmissions were respectively 0.42 , 0.56 and 0.66 . Adjustment models using clinical information performed better . Conclusion : Adjusted rates of potentially avoidable readmissions are scientifically sound enough to warrant their inclusion in hospital quality surveillance BACKGROUND the usefulness of geriatric evaluation and management ( GEM ) approaches in the care of frail elderly patients remains uncertain . We examined whether an inpatient geriatric consultation service might be beneficial in a country with a social welfare system . METHODS we conducted a r and omised trial with 345 patients from five centres . Ninety additional patients from four separate centres without GEM teams served as an external comparison . All patients were hospitalised , at least 65 years and frail . Patients were r and omly assigned to either comprehensive geriatric assessment and management in the form of consultations and follow-up or usual care . Primary outcomes were rehospitalisation and nursing home placement 1 year after r and omisation . Secondary outcomes were survival , functional , emotional and cognitive status , social situation and quality of life . FINDINGS at 12 months , the groups did not differ in the rate of rehospitalisation ( intervention 67 % , control 60 % , P=0.30 ) , nursing home placement ( intervention 19 % , control 14 % , P=0.27 ) , survival ( intervention 81 % , control 85 % , P=0.56 ) or any of the other secondary measures . The external comparison groups were also similar in nursing home placement ( 16 % , P=0.40 ) , survival ( 80 % , P=0.88 ) and all the secondary variables , but rehospitalisation was less ( 48 % , P=0.04 ) . No subgroup benefited from the intervention . INTERPRETATION care provided by consultation teams did not improve the rates of rehospitalisation or nursing home placement . This is not due to carry-over effects of geriatric knowledge into the control group Research is needed to help identify interventions that will improve the capacity or functioning of health systems and thereby contribute to achieving global health goals . Well conducted , r and omized controlled trials ( RCTs ) , insofar as they reduce bias and confounding , provide the strongest evidence for identifying which interventions delivered directly to individuals are safe and effective . When ethically feasible , they can also help reduce bias and confounding when assessing interventions targeting entire health systems . However , additional challenges emerge when research focuses on interventions that target the multiple units of organization found within health systems . Hence , one can not complacently assume that r and omization can reduce or eliminate bias and confounding to the same degree in every instance . While others have articulated arguments in favour of alternative design s , this paper is intended to help people underst and why the potential value afforded by RCTs may be threatened . Specifically , it suggests six points to be borne in mind when exploring the challenges entailed in design ing or evaluating RCTs on health system interventions : ( i ) the number of units available for r and omization ; ( ii ) the complexity of the organizational unit under study ; ( iii ) the complexity of the intervention ; ( iv ) the complexity of the cause-effect pathway , ( v ) contamination ; and ( vi ) outcome heterogeneity . The authors suggest that the latter may be informative and that the reasons behind it should be explored and not ignored . Based on improved underst and ing of the value and possible limitations of RCTs on health system interventions , the authors show why we need broader platforms of research to complement RCTs OBJECTIVES To evaluate an interdisciplinary intervention program for older people with hip fracture in Taiwan . DESIGN R and omized experimental design . SETTING A 3,800-bed medical center in northern Taiwan . PARTICIPANTS Elderly patients with hip fracture ( N=137 ) were r and omly assigned to an experimental ( n=68 ) or control ( n=69 ) group . INTERVENTION An interdisciplinary program of geriatric consultation , continuous rehabilitation , and discharge planning . MEASUREMENTS Demographic and outcome variables were measured . Outcome variables included service utilization , clinical outcomes , self-care abilities , health-related quality -of-life ( HRQOL ) outcomes , and depressive symptoms . RESULTS Subjects in the experimental group improved significantly more than those in the control group in the following outcomes : ratio of hip flexion 1 month after discharge ( P=.02 ) , recovery of previous walking ability at 1 month ( P=.04 ) and 3 months ( P=.001 ) after discharge , and activities of daily living at 1 month ( P=.01 ) and 2 months ( P=.001 ) after discharge . Three months after discharge , the experimental group showed significant improvement in peak force of the fractured limb 's quadriceps ( P=.04 ) and the following health outcomes : bodily pain ( P=.03 ) , vitality ( P<.001 ) , mental health ( P=.02 ) , physical function ( P<.001 ) , and role physical ( P=.006 ) . They also had fewer depressive symptoms ( P=.008 ) 3 months after discharge . CONCLUSION This intervention program may benefit older people with hip fractures in Taiwan by improving their clinical outcomes , self-care abilities , and HRQOL and by decreasing depressive symptoms within 3 months after discharge OBJECTIVE To test the impact of a geriatric evaluation and management model on the costs of acute hospital management of emergently admitted older adults . DESIGN R and omized controlled trial . Patients were followed in the acute hospital from admission through discharge . Results based on both univariate and multiple regression analyses . SETTING Private , nonprofit , academic medical center in a densely populated urban area . PATIENTS Adults 70 years of age and older admitted from the Emergency Department to the medicine service ( non-ICU admission ) who did not have an internist on staff at the admitting hospital . Of 141 r and omized patients , 111 ( 78.7 % ) met eligibility criteria . INTERVENTION Assignment of a geriatrician and a social worker as the primary managing team during the hospital stay . MAIN OUTCOME MEASURES Length of stay , total cost of acute hospital care , cost of laboratory , pharmacy , and rehabilitation services . RESULTS Patients in the intervention group had 2.1 fewer days of hospitalization , but this shorter length of stay was not statistically significant ( P = 0.108 ) . There were no differences in mortality or discharge disposition . In risk-adjusted , multiple regression analysis the intervention group had a statistically significant lower predicted total cost per patient than the usual care group ( -$2,544 , P = 0.029 ) ; assignment to the intervention group was associated with a lower predicted cost per patient for laboratory ( including cardiology graphics ) services ( P = 0.007 ) and pharmacy costs ( P = 0.047 ) . CONCLUSIONS When controlled for important predictors of expected re source use , care provided by a geriatric management team result ed in a significant reduction in the cost of hospitalization . A reduction in the cost of laboratory , cardiographic , and pharmacy services is consistent with the team 's philosophy of defining the services needed based on goals related to functional outcomes OBJECTIVES To develop a self-report screening tool to identify older people in the emergency department ( ED ) of a hospital at increased risk of adverse health outcomes , including : death , admission to a nursing home or long-term hospitalization , or a clinical ly significant decrease in functional status . DESIGN Prospect i ve ( 6-month ) follow-up study of a cohort of ED patients aged 65 and older . SETTING The EDs of four acute-care hospitals in Montreal , Quebec , Canada . PARTICIPANTS Community-dwelling patients aged 65 and older who came to the EDs during the weekday shift over a 3-month recruitment period . Patients were excluded if they could not be interviewed either because of their medical condition or because of cognitive impairment and no other informant was available . MEASUREMENTS Measures ascertained at the ED visit included : 27 self-report screening questions on social , physical , and mental risk factors ; medical history ; use of hospital services , medications , and alcohol ; and the Older American Re sources and Services ( OARS ) activities of daily living ( ADL ) scale . At follow-up , the OARS scale was readministered by telephone , and other adverse health outcomes were ascertained . RESULTS Among 1673 patients who completed the follow-up measures , 488 ( 29.2 % ) had an adverse health outcome . Scale development and selection methods included logistic regression , receiver operating characteristic curves , and expert judgment . The proposed screening tool ( ISAR ) comprises six self-report questions on functional dependence ( premorbid and acute change ) , recent hospitalization , impaired memory and vision , and polymedication . The tool performed well in the total cohort aged 65 and older , and in sub-groups defined by disposition ( admitted or released from ED ) , language of question naire administration ( French or English ) , information source ( patient or other ) , and other characteristics . CONCLUSIONS The ISAR is a short self-report question naire that can quickly identify older patients in the ED at increased risk of several adverse health outcomes and those with current disability OBJECTIVES To evaluate whether an early multidisciplinary geriatric intervention in elderly patients with hip fracture reduced length of stay , morbidity , and mortality and improved functional evolution . DESIGN R and omized , controlled intervention trial . SETTING Orthopedic ward in a university hospital . PARTICIPANTS Three hundred nineteen patients aged 65 and older hospitalized for hip fracture surgery . INTERVENTION Participants were r and omly assigned to a daily multidisciplinary geriatric intervention ( n=155 ) or usual care ( n=164 ) during hospitalization in the acute phase of hip fracture . MEASUREMENTS Primary endpoints were in-hospital length of stay and incidence of death or major medical complications . Secondary endpoints were the rate of recovery of previous activities of daily living and ambulation ability at 3 , 6 , and 12 months . RESULTS Median length of stay was 16 days in the geriatric intervention group and 18 days in the usual care group ( P=.06 ) . Patients assigned to the geriatric intervention showed a lower in-hospital mortality ( 0.6 % vs 5.8 % , P=.03 ) and major medical complications rate ( 45.2 % vs 61.7 % , P=.003 ) . After adjustment for confounding variables , geriatric intervention was associated with a 45 % lower probability of death or major complications ( 95 % confidence interval=7 - 68 % ) . More patients in the geriatric intervention group achieved a partial recovery at 3 months ( 57 % vs 44 % , P=.03 ) , but there were no differences between the groups at 6 and 12 months . CONCLUSION Early multidisciplinary daily geriatric care reduces in-hospital mortality and medical complications in elderly patients with hip fracture , but there is not a significant effect on length of hospital stay or long-term functional recovery Background and aims : Older hospitalized patients are at risk of functional decline , which is associated with several negative outcomes . The aim of this study was to compare the predictive accuracy of the Identification of Seniors At Risk ( ISAR ) , Variable Indicative for Placement risk ( VIP ) and the Flemish version of the Triage Risk Screening Tool ( TRST ) in predicting functional decline . Methods : A prospect i ve cohort study with 30 days follow-up in geriatric , medical and surgical wards in 25 hospitals was conducted . 752 participants aged 75 years or older were eligible for inclusion . Baseline data were gathered within 72 hours of admission . Functional decline was defined as an increase of one point or more from the premorbid Katz score to the score 30 days post-discharge . Positive predictive value ( PPV ) and negative predictive value ( NPV ) were calculated on 2 × 2 tables as well as by Bayes ’ theorem . Results : Functional decline at 30 days postdischarge was observed in 279 participants ( 39 % ) . ISAR and Flemish TRST showed high sensitivity ( 88%–78 % ) and fair NPV ( 62%–67 % ) , but low specificity ( 19%–30 % ) and low PPV ( 47%–48 % ) using the original cut-off of ≥2 . The sensitivity of VIP with cut-off ≥2 was too low ( 62 % ) , but could be optimized with cut-off ≥1 , showing sensitivity , specificity , PPV and NPV of 88 % , 21 % , 48 % and 68 % , respectively . Accuracy varied between 40 % and 61 % for all instruments on all calculated cut-offs . Conclusions : All three instruments performed similarly well , showing good sensitivity and fair NPV , the two major characteristics for good screening tools . False positives could be filtered out according to the clinical expert opinion of a care team A controlled trial was conducted to examine the effects of superimposing an interdisciplinary geriatric consultation team upon the conventional patterns of care in medical wards of an acute care hospital . Two hundred and twenty-two patients , aged 69 years of age or older , admitted from the emergency room to two trial wards and 182 similar patients admitted to two control wards where the team did not work , were followed . Evaluations at admission , two and four weeks , and three and six months postadmission by independent evaluators allowed comparisons between the care groups with reference to survival , length of stay , disposition , physical , mental , and social functional levels , and use of services after discharge . Data from charts and treatment logs allowed the care processes to be compared . Findings determined that patients in the two groups were alike on socio-demographic and clinical characteristics at entry . Results demonstrated that patients in the trial and control groups fared similarly on the outcome measures at each evaluation point , although a trend toward better survival among team patients was noted . It was concluded that the addition of a consultative geriatric team to the medical wards failed to show a significant impact on patient outcomes STUDY OBJECTIVE To evaluate the impact of a geriatric consultation team on the functional status of hospitalized elderly patients . DESIGN R and omized controlled clinical trial . SETTING University-affiliated referral Veterans Administration Medical Center . PATIENTS One hundred and seventy-eight hospitalized elderly men 75 years or older admitted to medical , surgical , and psychiatry services , but excluding patients admitted to intensive care units . INTERVENTION Eighty-eight intervention group patients received multidimensional evaluation by an interdisciplinary geriatric consultation team composed of a faculty geriatrician , geriatrics fellow , geriatric clinical nurse specialist , and a social worker trained in geriatrics . Results of the evaluation , including problem identification and recommendations , were given to the patients ' physicians . Ninety control group patients received only usual care . MEASUREMENTS AND MAIN RESULTS Intervention and control groups were comparable initially . The major outcome variable was the Index of Independence in the Activities of Daily Living ( ADL ) ( Katz ) . Thirty-nine percent of the total study population was functionally independent on admission , 27 % required assistance with one to three ADL , 22 % required assistance with four to six ADL , and 12 % were completely dependent . Many patients remained unchanged from admission to discharge : intervention group , 38 % ; control group , 39 % . In the intervention group , 34 % improved and 28 % declined ; in the control group , 26 % improved and 36 % declined . Although these changes reflected a trend toward greater improvement in the intervention group , the results were not statistically significant . CONCLUSIONS Among elderly patients entering an acute-care hospital , approximately 60 % had some degree of , and one third had serious functional disability . Such patients are at risk for further decline during hospitalization . A geriatric consultation team was unable to alter the degree of functional decline . Geriatric units or consultation teams may have to offer direct preventive or restorative services in addition to advice if improvements are to be made OBJECTIVE To evaluate the effect of an Inpatient Geriatric Consultation Team on patient outcome . DESIGN R and omized controlled clinical trial . SETTING A non-academic-affiliated 503-bed community hospital . PATIENTS All in patients over the age of 70 years . Sixty-two patients received multidimensional geriatric assessment , and 58 patients received no intervention . INTERVENTION Team assessment , leading to formal recommendations to the attending physician . MEASUREMENTS Data were collected on hospital length of stay , referrals to community service , discharge destination , hospital readmissions in 6 months , number of post-discharge physician visits , and change in functional status . Mortality at 6 months and at 1 year was determined for each patient . MAIN RESULTS At 6 months , 12/58 patients ( 21 % ) had died in the control group versus 3/62 ( 6 % ) patients in the experimental group ( P = 0.01 ) . During hospitalization , the length-of-stay was 10.1 days for the control group versus 9.0 days for the experimental group ( P = 0.20 ) . The control group had significantly more readmissions ( 0.6 per patient vs 0.3 per patient , P = 0.02 ) . A higher number of experimental patients , 22 % ( 13/59 ) , showed improvement in ADL scores compared with 7 % ( 4/46 ) of control patients , P = 0.07 . At one year for all r and omized patients , 7/68 ( 10 % ) of experimental patients and 13/64 ( 20 % ) of control patients had died . CONCLUSIONS Short-term mortality can be reduced in community inpatient acute hospital setting s by comprehensive geriatric consultation teams . Important differences in mortality remain at 1 year of followup . Trends towards improved functional status and fewer hospital readmissions favor the intervention group Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument The structure and function of a newly created interdisciplinary Geriatric Consultation Team ( GCT ) are described . The GCT was introduced on a single medical unit , where consultations were given to 46 consecutive patients aged 75 years and over . The GCT patients had , on the average , 5.5 illnesses and were receiving 3.7 medications . Anemia ( 50 per cent ) , were hypoalbuminemia ( 65 per cent ) , and elevated blood urea nitrogen ( BUN ) ( 58 per cent ) were frequent . Functional assessment showed frequent dependence on others for assistance with ambulation ( 59 per cent ) , transfers ( 54 per cent ) , and dressing ( 52 per cent ) ; cognitive impairment was found in 52 per cent and clinical depression in 11 per cent of the patients . In comparison with control units , the GCT increased use of physical therapy by 357 per cent , occupational therapy by 390 per cent , and speech therapy by 300 per cent without increasing length of stay . In comparison with control subjects , GCT patients had no decrease in hospital readmission rates ( 43 per cent ) over 10.5 months of follow up . It was concluded that a GCT in an acute-care hospital promotes geriatrics , teaches interdisciplinary teamwork , improves awareness of functional problems of patients , and increases use of rehabilitative services , but does not decrease the high rate of readmission of hospitalized geriatric patients As part of a prospect i ve , r and omized , controlled study of the effectiveness of a geriatric consultation team , we examined compliance by the house staff with recommendations made by the team . Recommendations were formulated for 185 patients , aged 75 years or older , who were r and omized into intervention ( n = 92 ) and control ( n = 93 ) groups . In the control group , only 27.1 % of the actions that would have been recommended by the team were implemented independently by the house staff . Problems commonly neglected included polypharmacy , sensory impairment , confusion , and depression . In the intervention group , overall compliance was 71.7 % . Highest compliance occurred for recommendations addressing instability and falls ( 95.0 % ) and discharge planning ( 94.3 % ) . We conclude that a geriatric consultation team contributes substantial additional input into the care of older patients . Furthermore , relatively high compliance can be achieved with recommendations made by a geriatric consultation team , thereby overcoming the first barrier to the establishment of such a service PURPOSE To determine the effectiveness of inpatient interdisciplinary geriatric consultation provided during hospitalization to frail , elderly subjects . SUBJECTS AND SITE : Admission cohort of 197 men admitted from 1985 through 1989 , aged 65 years or more , meeting proxy criteria for frailty , living within follow-up area , without terminal illness , and without prolonged nursing home residence . METHODS AND MEASURES R and omized controlled trial of inpatient geriatric consultation at a tertiary care Veterans Affairs hospital . Differences were determined between groups in the Physical Self-Maintenance Scale , Instrumental Activities of Daily Living , Mini-Mental State Examination , Morale Scale , and nursing home and health care utilization . RESULTS No differences were seen between groups in any measure after the intervention or during 1 year of follow-up . Intervention implementation may have been incomplete due to compliance and re source availability . CONCLUSIONS This trial is not definitive in determining whether geriatric consultation is effective or ineffective . Lessons learned from this research indicate that future studies should target frail subjects , include intervention-specific measures , and be conducted with direct control of comprehensive re sources BACKGROUND Although many studies describe benefits from the comprehensive assessment of elderly patients by an interdisciplinary team ( comprehensive geriatric assessment ) , the most supportive evidence for the process has come from programs that rely on specialized inpatient units and long hospital stays . We examined whether an inpatient geriatric consultation service might also be beneficial in a trial involving four medical centers of a group- practice health maintenance organization ( HMO ) . METHODS We conducted a r and omized clinical trial with 2353 hospitalized patients 65 years of age or older in whom at least 1 of 13 screening criteria were present : stroke , immobility , impairment in any basic activity of daily living , malnutrition , incontinence , confusion or dementia , prolonged bed rest , recent falls , depression , social or family problems , an unplanned readmission to the hospital within three months of a previous hospital stay , a new fracture , and age of 80 years or older . Of the 1337 patients assigned to the experimental group , 1261 ( 94 percent ) received a comprehensive geriatric assessment in the form of a consultation , with limited follow-up ; the 1016 patients assigned to the control group received usual care . The functional and health status of the patients was measured at base line and 3 and 12 months later ; survival was assessed at 12 months . Subgroups of patients who might be presumed to benefit from comprehensive assessment were also studied . RESULTS The survival rate at 12 months was 74 percent in the experimental group and 75 percent in the control group . At base line , 3 months , and 12 months the scores of the two groups on measures of functional and health status were similar . The analysis of 16 subgroups did not identify any with either clearly improved functional status or improved survival . CONCLUSIONS In this HMO , comprehensive geriatric assessment by a consultation team , with limited follow-up , did not improve the health or survival of hospitalized patients selected on the basis of screening criteria Attempts to prove the usefulness of geriatric consultation teams ( GCT ) in acute-care setting s have been inconclusive . We have completed a prospect i ve , controlled trial of a GCT in an acute-care setting , aim ing our interventions at a specific subgroup of elderly patients . One hundred and thirty-two out of 352 ( 37.5 % ) patients met the inclusion criteria with 66 each being assigned to the intervention and the control groups . There were no significant differences in baseline characteristics between the two groups . Patients in the intervention group received follow-up after discharge from hospital by the geriatric service . We found that the intervention was associated with improved 6-month survival ( p less than 0.01 ) , improved Barthel Index at 1 year ( p less than 0.01 ) , and a trend towards decreased reliance on institutional care ( hospital or nursing home ) during the year of follow-up . The benefits occurred principally in patients who were discharged to a nursing home . Our findings support the utility of GCT and highlight the importance of focusing the intervention and providing follow-up after discharge from hospital |
1,321 | 27,757,813 | In the anterior compartment , mesh repairs seem to offer clearly superior efficacy and durability of results compared to native tissue repairs , but with an equally clear increase in complication rates .
As far as the apical compartment is concerned , sacrocolpopexy is the most efficacious , yet the most invasive procedure . | Awareness and reporting of mesh-related complications of pelvic organ prolapse repairs have increased in recent years .
As a result , deciding whether to use a mesh or not has become a difficult task for urogynecologists .
Our aim was to summarize reasons for and against the use of mesh in prolapse repair based on a review of relevant literature . | OBJECTIVE : To present the 3-year outcomes of a double-blind , multicenter , r and omized trial comparing vaginal prolapse repair with and without mesh . METHODS : This was a planned final analysis of women with Pelvic Organ Prolapse Quantification ( POP-Q ) stage 2–4 prolapse r and omized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh . We evaluated anatomic , symptomatic , and combined cure rates for those with at least 3-year vali date d quality -of-life question naires and 2- or 3-year postoperative blinded POP-Q examination . Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis . RESULTS : Sixty-five women were enrolled ( 33 mesh , 32 no mesh ) before the study was prematurely halted as a result of a 15.6 % mesh exposure rate . At 3 years , 51 of 65 ( 78 % ) had quality -of-life question naires ( 25 mesh , 26 no mesh ) and 41 ( 63 % ) had examinations . Three participants died , three required reoperation for recurrent prolapse ( all in mesh group ) , and eight were lost to follow-up . No differences were observed between groups at 3 years for prolapse stage or individual prolapse points . Stage improved for each group ( 90 % and 86 % ) from baseline to 3 years ( P<.01 ) . Symptomatic improvement was observed with no differences in scores between groups . Cure rates did not differ between groups using a variety of definitions , and anatomic cure was lowest for the anterior compartment . CONCLUSION : There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh . CLINICAL TRIAL REGISTRATION : Clinical trials.gov , www . clinical trials.gov , NCT00475540 . LEVEL OF EVIDENCE : Introduction and hypothesisTo compare the efficacy of a collagen-coated polypropylene mesh and anterior colporrhaphy in the treatment of stage 2 or more anterior vaginal wall prolapse . Methods Prospect i ve , r and omized , multicenter study conducted between April 2005 and December 2009 . The principal endpoint was the recurrence rate of stage 2 or more anterior vaginal wall prolapse 12 months after surgery . Secondary endpoints consisted of functional results and mesh-related morbidity . Results One hundred and forty-seven patients were included , r and omized and analyzed : 72 in the anterior colporrhaphy group and 75 in the mesh group . The anatomical success rate was significantly higher in the mesh group ( 89 % ) than in the colporrhaphy group ( 64 % ) ( p = 0.0006 ) . Anatomical and functional recurrence was also less frequent in the mesh group ( 31.3 % vs 52.2 % , p = 0.007 ) . Two patients ( 2.8 % ) were reoperated on in the colporrhaphy group for anterior vaginal wall prolapse recurrence . No significant difference was noted regarding minor complications . An erosion rate of 9.5 % was noted . De novo dyspareunia occurred in 1/14 patients in the colporrhaphy group and in 3/13 patients in the mesh group . An analysis of the quality of life question naires showed an overall improvement in both groups , with no statistical difference between them . Satisfaction rates were high in both groups ( 92 % in the colporrhaphy group and 96 % in the mesh group ) . Conclusion Trans-obturator Ugytex ® mesh used to treat anterior vaginal wall prolapse gives better 1-year anatomical results than traditional anterior colporrhaphy , but with small a increase in morbidity in the mesh group Introduction and hypothesisThis trial aim ed to compare the outcomes of native vaginal tissue repair versus polypropylene mesh repair for the treatment of severe genital prolapse . Methods This multicenter r and omized trial included 184 women , with POP-Q stage 3 or 4 . They were r and omly assigned to undergo surgical treatment using native tissue repair ( n = 90 ) or synthetic mesh repair ( n = 94 ) . Native tissue repair surgery was performed according to site-specific defects , including sacrospinous ligament fixation for apical defects . Mesh repair ( Prolift ™ ) was performed in accordance with manufacturer recommendations . Hysterectomy was performed in all cases of uterine prolapse . Statistical tests were used to compare between-group and within-group differences before the surgery and at 1-year follow-up . We considered cure to have occurred when the POP-Q point evaluation was equal to or less than 0 and POP-Q point C better than or equal to half the total vaginal length ( TVL ) after 1 year . The patients answered the Prolapse Quality -of-Life Question naire ( PQoL ) and the Sexual Quotient Female Version ( QS-F ) question naire . Results Both groups were homogeneous preoperatively . There were no differences between the groups in operative time , complications or pain . At 1-year follow-up , anatomical cure rates were better in the mesh group in the anterior compartment ( p = 0.019 ) . Significant improvement in PQoL scores at 1-year follow up were observed in each group ; between-group comparisons of changes in PQoL scores revealed greater improvement in the mesh group . Conclusion Both techniques were effective . Anatomical efficacy was superior in the mesh group regarding the anterior compartment ; quality of life changes were also greater in the mesh group . Complications were significantly higher in the mesh group AIMS To compare efficacy and safety of the traditional colporraphy and transvaginal polypropylene mesh for the treatment of advanced anterior vaginal prolapse according to different success criteria in two-year follow-up . METHODS In this r and omized controlled trial , women with anterior prolapse stage II or greater , with Ba point ≥ + 1 ( POP-Q quantification ) , were r and omly assigned to have either anterior colporraphy ( n = 43 ) or transvaginal mesh repair ( n = 43 ) . The primary outcome was to compare objective success rate under two success definitions : prolapse stage I ( Ba < -1 ) and stage II ( Ba < 0 ) . Secondary outcomes included complications and prolapse symptoms , satisfaction and quality of life ( QoL ) . Intention to treat was used for the primary endpoint and per protocol analysis for the secondary outcomes . RESULTS The groups presented similar preoperative data . Thirty three patients from the colporraphy and 37 from the mesh groups completed two-year follow-up . Under Ba < -1 definition , success rate was 39.53 % for both groups ( P = 1.00 ) . Considering success as Ba < 0 , analysis favored the mesh group by 23 % ( 51.16 % and 74.42 % ; 95 % CI for difference : 3 - 43 % ; P = 0.022 ) . Patients from the mesh group were more satisfied after two years ( 81.8 % and 97.3 % for colporraphy and mesh , respectively , 15.5 % difference ; 95 % CI for difference 1 - 29 % ; P = 0.032 ) . Both procedures similarly improved women 's symptoms and QoL. Some complications were observed , one being a 13.5 % mesh exposure rate . CONCLUSIONS Transvaginal synthetic mesh repair for advanced anterior vaginal prolapse provided higher anatomical success and satisfaction rates compared with traditional colporraphy . Both procedures equally improved quality of life . Neurourol . Urodynam . 35:509 - 514 , 2016 . © 2015 Wiley Periodicals , Introduction and hypothesisEstimation on prevalence and distribution of pelvic organ prolapse ( POP ) signs in a general female population is difficult . We therefore developed and vali date d a prediction model and prognostic instrument . Methods Question naires were sent to a general female population ( 45–85 years ) . A r and om sample underwent vaginal examination for POP ( POPQ ) . A prediction model was developed using multivariate analysis and vali date d in a subgroup of participants . Results Positive question naire-response rate was 46.8 % ( 1,397 of 2,979 ) . From the question naire group , 649 women were vaginally examined ( 46.5 % ) . Prevalence of clinical ly relevant POP was 21 % . Multivariate analysis demonstrated significantly higher odds ratios on the report of vaginal bulging , parity ≥2 and a mother with POP . The receiver operating characteristic curve showed areas under the curve of 0.672 and 0.640 . Conclusions The prevalence of POP at or beyond the hymen could be estimated in a general female population using our prediction model with 17 questions and our POP score chart with eight questions Objective To compare the effects of vaginal hysterectomy ( combined with anterior and /or posterior colporraphy ) and abdominal sacro‐colpopexy ( with preservation of the uterus ) on urogenital function OBJECTIVE To compare the efficacy of two st and ard surgical procedures for post-hysterectomy vaginal vault prolapse in patients with levator ani avulsion . METHODS This was a single-center , r and omized interventional trial , of two st and ard surgical procedures for post-hysterectomy vaginal vault prolapse : Prolift Total vs unilateral vaginal sacrospinous colpopexy with native tissue vaginal repair ( sacrospinous fixation , SSF ) , during the period from 2008 to 2011 . Entry criteria included at least two-compartment prolapse , as well as complete unilateral or bilateral levator ani avulsion injury . The primary outcome was anatomical failure based on clinical and ultrasound assessment . Failure was defined clinical ly , according to the Pelvic Organ Prolapse Quantification system , as Ba , C or Bp at the hymen or below , and on translabial ultrasound as bladder descent to 10 mm or more below the lower margin of the symphysis pubis on maximum Valsalva maneuver . Secondary outcomes were evaluation of continence , sexual function and prolapse symptoms based on vali date d question naires . RESULTS During the study period , 142 patients who were post-hysterectomy underwent surgery for prolapse in our unit ; 72 of these were diagnosed with an avulsion injury and were offered participation in the study . Seventy patients were r and omized into two groups : 36 in the Prolift group and 34 in the SSF group . On clinical examination at 1-year follow-up , we observed one ( 3 % ) case of anatomical failure in the Prolift group and 22 ( 65 % ) in the SSF group ( P < 0.001 ) . Using ultrasound criteria , there was one ( 2.8 % ) failure in the Prolift group compared with 21 ( 61.8 % ) in the SSF group ( P < 0.001 ) . The postoperative POPDI ( Pelvic Organ Prolapse Distress Inventory ) score for subjective outcome was 15.3 in the Prolift group vs 21.7 in the SSF group ( P = 0.16 ) . CONCLUSION In patients with prolapse after hysterectomy and levator ani avulsion injury , SSF has a higher anatomical failure rate than does the Prolift Total procedure at 1-year follow-up BACKGROUND The use of st and ardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years , but it is unclear whether this approach results in better outcomes than traditional colporrhaphy . METHODS In this multicenter , parallel-group , r and omized , controlled trial , we compared the use of a trocar-guided , transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall ( cystocele ) . The primary outcome was a composite of the objective anatomical design ation of stage 0 ( no prolapse ) or 1 ( position of the anterior vaginal wall more than 1 cm above the hymen ) , according to the Pelvic Organ Prolapse Quantification system , and the subjective absence of symptoms of vaginal bulging 12 months after the surgery . RESULTS Of 389 women who were r and omly assigned to a study treatment , 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy . At 1 year , the primary outcome was significantly more common in the women treated with transvaginal mesh repair ( 60.8 % ) than in those who underwent colporrhaphy ( 34.5 % ) ( absolute difference , 26.3 percentage points ; 95 % confidence interval , 15.6 to 37.0 ) . The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group ( P<0.001 for both comparisons ) . Rates of bladder perforation were 3.5 % in the mesh-repair group and 0.5 % in the colporrhaphy group ( P=0.07 ) , and the respective rates of new stress urinary incontinence after surgery were 12.3 % and 6.3 % ( P=0.05 ) . Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2 % of 186 patients in the mesh-repair group . CONCLUSIONS As compared with anterior colporrhaphy , use of a st and ardized , trocar-guided mesh kit for cystocele repair result ed in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events . ( Funded by the Karolinska Institutet and Ethicon ; Clinical Trials.gov number , NCT00566917 . ) Purpose To compare the clinical effectiveness of anterior colporrhaphy versus mesh repair as surgical management of anterior vaginal prolapse . Methods Of 50 patients with ≥stage II anterior vaginal prolapse on Pelvic Organ Prolapse Quantification ( POPQ ) system who were initially approached , 44 consented and underwent surgery . They were r and omly recruited into two groups . Group I ( 23 patients ) received anterior colporrhaphy , while group II ( 21 patients ) received soft polypropylene mesh ( GYNEMESH*PS , Gynecare , Ethicon , France ) . Clinical assessment took place preoperatively and postoperatively at definite intervals . Functional and anatomical comparisons were based on comparison between preoperative and 24 months postoperative assessment s of symptoms and POPQ stages , respectively . Four patients in total did not complete the follow-up assessment s and were excluded . Results Both groups showed clinical improvement in their symptoms and POPQ staging at the end of the postoperative follow-up period . Improvement , however , was more significant in the repair with mesh group , as patients in this group reported better improvement of their prolapse symptoms , mainly vaginal bulge/pressure sensation ( P < 0.05 ) , and showed better improvement in the anatomical staging , individual POP-Q points Aa and Ba ( P < 0.01 ) , than the anterior colporrhaphy group . Group II also showed more satisfactory outcome with the general POP-Q staging ( P < 0.05 ) than group I , reflecting a better quality of life of the patients in the repair with mesh group . Conclusion Our data shows that repair with mesh is superior to anterior colporrhaphy with more satisfactory outcome to the patients . Due to the small size of our study and uncertainty of the long-term safety and resilience of the mesh , we recommend larger studies to confirm our preliminary results INTRODUCTION In pelvic organ prolapse ( POP ) repair , the use of synthetic mesh is not only increasing but also a subject of discussion . The focus shifts from anatomical toward functional outcome , with sexual function being an important parameter . One of the concerns with mesh usage in POP surgery is the possible negative effect on sexual function . AIM To compare and assess sexual function in women and men after primary cystocele repair with or without trocar-guided transobturator mesh . METHODS One hundred twenty-five women with a symptomatic cystocele stage ≥ II were included in this multicenter r and omized controlled trial and assessed at baseline and 6-month follow-up . MAIN OUTCOME MEASURES Female sexual function was measured by the Female Sexual Function Index ( FSFI ) and male sexual function by the Male Sexual Health Question naire . A subgroup analysis of women with a participating partner was performed . RESULTS In the mesh group , 54/59 women vs. 53/62 in the anterior colporrhaphy group participated . In men , 29 vs. 30 participated . After surgery , FSFI scores were comparable for both treatment groups . However , within group analysis showed significant improvement on the domains pain ( effect size = 0.5 ) , lubrication ( effect size = 0.4 ) , and overall satisfaction ( effect size = 0.5 ) in the colporrhaphy group . This improvement was not observed in the mesh group . A subgroup of women with a participating partner reported significantly higher baseline domain scores as compared with other women and did not report a significant improvement of sexual functioning irrespective of treatment allocation . Worsening of baseline sexual function was reported by 43 % of women in the mesh group compared with 18 % in anterior colporrhaphy group ( P = 0.05 ) . Male sexual functioning did not change in either group . CONCLUSIONS Women after an anterior colporrhaphy report a significant and clinical ly relevant improvement of their sexual functioning , whereas women after a mesh procedure did not Background / Aims : To report objective and subjective outcomes and adverse events after placement of Elevate ® Posterior transvaginal mesh without concurrent surgery . Changes in non-affected anterior compartment were under special interest . Methods : A prospect i ve study of Elevate ® Posterior procedure in patients with symptomatic posterior compartment prolapse . Pelvic organ prolapse ( POP ) quantification ( POP-Q ) measurements and Pelvic Floor Dysfunction Inventory-20 ( PFDI-20 ) and POP/urinary Incontinence Sexual Question naire ( PISQ-12 ) question naires were used . Primary outcome was the incidence of de novo anterior prolapse . Secondary outcomes were complication rate and posterior compartment objective and subjective cure . Results : A total of 111 women underwent an Elevate ® Posterior mesh procedure and 109 attended a control visit at 3 months . De novo anterior prolapse emerged in 3.2 - 15 % of the women , depending on the definition . Posterior POP-Q stage ≤I was obtained in 92 ( 84 % ) women and leading edge at or above the hymen in 107 ( 98 % ) women . Bulge symptoms disappeared in 86 % of the cases . One ( 0.9 % ) mesh exposure was detected . Reoperation rate was 2.8 , and 3.7 % patients experienced postoperative pain . PFDI-20 and PISQ-12 scores improved significantly . Conclusions : A trend of de novo prolapse formation in the non-affected vaginal compartment is observed . The Elevate ® Posterior method is effective in terms of both objective and subjective outcomes . According to our results , the mesh exposure rate is low OBJECTIVE The purpose of this study was to compare outcomes after anterior colporrhaphy with the use of 3 different surgical techniques . STUDY DESIGN One hundred fourteen women with anterior vaginal prolapse were r and omly assigned to undergo anterior repair by one of 3 techniques : st and ard , st and ard plus polyglactin 910 mesh , or ultralateral anterior colporrhaphy . Before and after operation , patients underwent physical examination staging of prolapse ; the International Continence Society system was used . Symptoms were assessed by question naire and visual analog scales . We defined " cure " as satisfactory ( stage I ) or optimal ( stage 0 ) outcome at points Aa and Ba . RESULTS Of 114 patients who were originally enrolled , 109 patients underwent operation , and 83 patients ( 76 % ) returned for follow-up . Mean age ( + /- SD ) was 64.7 + /- 11.1 years . At entry , 7 patients ( 7 % ) had stage I anterior vaginal prolapse ; 35 patients ( 37 % ) had stage II anterior vaginal prolapse ; 51 patients ( 54 % ) had stage III anterior vaginal prolapse ; and 2 patients ( 2 % ) had stage IV anterior vaginal prolapse . At a median length of follow-up of 23.3 months , 10 of 33 patients ( 30 % ) who were r and omly assigned to the st and ard anterior colporrhaphy group experienced satisfactory or optimal anatomic results , compared with 11 of 26 patients ( 42 % ) with st and ard plus mesh and with 11 of 24 patients ( 46 % ) with ultralateral anterior colporrhaphy . The severity of symptoms that were related to prolapse improved markedly ( preoperative score , 6.9 + /- 2.7 ; postoperative score , 1.1 + /- 0.8 ) . Twenty-three of 24 patients ( 96 % ) no longer required manual pressure to void after operation . CONCLUSION These 3 techniques of anterior colporrhaphy provided similar anatomic cure rates and symptom resolution for anterior vaginal prolapse repair . The addition of polyglactin 910 mesh did not improve the cure rate compared with st and ard anterior colporrhaphy OBJECTIVE : To estimate the efficacy of midline fascial plication of the posterior vaginal wall in women with rectoceles and obstructed defecation . METHODS : Prospect i ve evaluation of 38 consecutive women with symptomatic rectoceles ( stage II or greater ) and obstructed defecation included pre- and postoperative st and ardized pelvic floor questions , pelvic organ prolapse quantification measurements , vali date d bowel function question naires , defecating proctogram , and patient satisfaction . Review s were conducted by nonsurgical co authors . RESULTS : The median follow-up was 12.5 months ( range 2.5–26 months ) . The subjective success rates were 97 % ( 95 % confidence interval [ CI ] 0.83–1.00 % ) at 12 months and 89 % ( 95 % CI 0.55–0.98 % ) at 24 months . The objective success rates were 87 % ( 95 % CI 0.64–0.96 % ) at 12 months and 79 % ( 95 % CI 0.51–0.92 % ) at 24 months . The average points , Ap and Bp , were significantly reduced from −0.1 ( range −2 to 3 ) and 1.1 ( range −1 to 8) , preoperatively , to −2.6 ( range −3 to −1 ) and −2.5 ( range −3 to 0 ) , postoperatively , respectively ( P < .001 ) . Depth of rectocele also reduced postoperatively on defecating fluoroscopy ( P < .001 ) . The correction of the anatomical defect was associated with improved functional outcome , with 33 women ( 87 % ) no longer experiencing obstructed defecation , and there was a significant reduction in postoperative straining to defecate , hard stools , and dyspareunia ( P = .001 ) . The improved anatomical and functional outcomes were reflected in the fact that 97 % of the women reported very high patient satisfaction . CONCLUSION : Midline fascial plication is effective in correcting anatomical and functional outcomes associated with symptomatic rectoceles and obstructed defecation . LEVEL OF EVIDENCE : Introduction and hypothesisOur aim was to compare anatomical and functional outcome between vaginal colposuspension and transvaginal mesh . Methods This was a prospect i ve r and omized controlled trial in a teaching hospital . Sixty-eight women with stage ≥3 anterior vaginal wall prolapse according to the Pelvic Organ Prolapse Quantification ( POP-Q ) system were assessed , r and omized , and analyzed . Patients were r and omized to anterior colporrhaphy with vaginal colposuspension ( n = 35 ) or transvaginal mesh ( n = 33 ) . Primary outcome was objective cure rate of the anterior vaginal wall , defined as POP-Q ≤1 at 2 years . Secondary outcomes were functional results , quality -of-life ( QoL ) scores , mesh-related morbidity , and onset of urinary incontinence . Results The anatomical result for point Ba was significantly better at 2 years in the mesh group ( −2.8 cm ) than in the colposuspension group ( −2.4 cm ) ( p = 0.02 ) . Concerning POP-Q stages , the anatomical success rate at 2 years was 84.4 % for colposuspension and 100 % for mesh ( p = 0.05 ) . There were 5 anatomic recurrences ( 15.6 % ) in the colposuspension group . The erosion rate was 6 % ( n = 2 ) . No significant difference was noted regarding minor complications . Analysis of QoL question naires showed overall improvement in both groups , with no significant difference between them . Conclusions The vaginal colposuspension technique of anterior vaginal wall prolapse repair gave good anatomical and functional results at 2 years . Transobturator vaginal mesh gave better 2-year anatomical results than vaginal colposuspension , with overall improvement in QoL in both groups OBJECTIVE To compare infracoccygeal sacropexy ( IS ) and sacrospinous suspension ( SS ) for the treatment of uterine or vault prolapse . METHODS A r and omized trial of 49 women assigned to either the IS group using IVS tape ( n=24 ) or SS group ( n=25 ) . Concomitant hysterectomy and repairs were performed as appropriate . Evaluations included prolapse staging using the POP-Q system and vali date d question naires for symptoms ( PFDI ) , quality of life ( PFIQ ) , and sexuality ( PISQ-12 ) . The primary outcome measure was postoperative pain . RESULTS Patients ' characteristics were similar in both groups . IS was quicker , easier , and less painful than SS ( P<0.01 ) . Hemorrhage or hematoma rates were similar . Neither rectal injury nor vaginal erosion occurred . Mean follow-up was 16.8 months . Prolapse cure rates , symptom scores , and quality of life were similar . Postoperative cystocele occurred in 4.8 % of women after IS and 25 % after SS ( P>0.05 ) . CONCLUSION Infracoccygeal sacropexy is equivalent to sacrospinous suspension , with a decreased rate of postoperative pain and cystocele recurrence Objectives : We determined the efficacy of the use of a tension free prolene mesh to correct a grade III anterior vaginal wall prolapse recurrence . Methods : Twelve women ( mean age 65.6 years ) with stress urinary incontinence ( SUI ) ( 4 type II and 1 type III ) and bladder prolapse entered the study . After vaginal incision a pretailored polypropylene mesh was fixed to its four angles by absorbable sutures to the urethropelvic ligaments and pubocervical fascia anteriorly and to the cardinal ligaments and pubocervical fascia posteriorly . When present , a posterior descensus was corrected during the same procedure . SUI was treated with the tension – free vaginal tape procedure ( TVT ) through a separate vaginal incision over the mid – urethra . Results : All patients were available for postoperative pelvic examination at 3–month intervals , for a mean follow – up of 20.5 months ( range 15–32 ) . Nine patients were considered cured ( no cystocele recurrence ) while in 3 patients a grade 1 asymptomatic cystocele was present postoperatively ( asymptomatic ) . No significant postoperative pain was reported by the patients . Conclusions : This study confirms that in patients with moderate cystocele a tension – free mesh to support bladder base and neck effectively treats the cystocele . It is particularly recommended in the treatment of previous failure with traditional techniques and when the quality of suspending tissue is poor or defective . A long – term study on a large number of patients is still warranted to confirm and vali date its clinical use OBJECTIVE The purpose of this study was to show 12-month outcomes of a r and omized trial that compared vaginal prolapse repair with and without mesh . STUDY DESIGN Women with stage ≥2 prolapse were assigned r and omly to vaginal repair with or without mesh . The primary outcome was prolapse stage ≤1 at 12 months . Secondary outcomes included quality of life and complications . RESULTS All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures . Thirty-two women had mesh repair ; 33 women had traditional repair . At 12 months , both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates . The quality of life improved and did not differ between groups : 96.2 % mesh vs 90.9 % no-mesh subjects reported a cure of bulge symptoms ; 15.6 % had mesh exposures , and reoperation rates were higher with mesh . CONCLUSION Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh . However , mesh result ed in a higher reoperation rate and did not improve 1-year cure OBJECTIVE The objective of the study was to compare recurrence and complication rates for sacrospinous fixation ( SSF ) and prolene mesh techniques for the primary treatment of posthysterectomy vaginal vault prolapse . STUDY DESIGN Patients undergoing surgery for vault prolapse were included in a multicenter , r and omized , controlled study comparing SSF or total mesh ( Prolift ; Gynecare/Ethicon , Somerville , NJ ) . The examination included pelvic organ prolapse quantification , urodynamics , ultrasound , and quality -of-life ( QoL ) question naires before and 3 and 12 months after surgery . RESULTS Of 168 r and omized patients , 83 underwent SSF and 85 mesh repair . Prolapse recurrence after 12 months occurred in 39.4 % of the SSF group and in 16.9 % of the mesh group ( P = .003 ) . The mesh exposure rate was 20.8 % . No difference in QoL improvement as well as of de novo stress urinary incontinence and overactive bladder onset was found . CONCLUSION Mesh exposure occurrence was balanced against a lower prolapse recurrence rate in the patients undergoing mesh surgery compared with those undergoing SSF OBJECTIVES : To report 1-year outcomes of a r and omized controlled trial comparing polypropylene mesh – reinforced anterior vaginal prolapse repair with anterior colporrhaphy . METHODS : Seventy-six patients with stage II or greater anterior vaginal prolapse were r and omly assigned to either colporrhaphy or polypropylene mesh repair . The primary outcome was recurrent stage II anterior vaginal prolapse , and secondary outcomes were effects on quality of life and sexual symptom scores , operative time , blood loss , length of hospitalization , and adverse events . RESULTS : Thirty-eight women had anterior colporrhaphy , and 37 had polypropylene mesh repair . One patient allocated to mesh repair withdrew from the study before surgery . Clinical and demographic data did not differ significantly between the two treatment groups . One year after surgery , optimal and satisfactory anterior vaginal support were obtained in 21 of 38 ( 55 % ) of the colporrhaphy group and 33 of 38 ( 87 % ) of the mesh group ( P=.005 ) . Patients in both groups reported less bother after surgery in both prolapse and urinary symptoms . The rates of de novo dyspareunia were 4 of 26 ( 16 % ) and 2 of 23 ( 9 % ) in the colporrhaphy and mesh groups , respectively . Two of 37 ( 5 % ) patients had vaginal mesh extrusion . Nine anterior colporrhaphy patients would have to have recurrent anterior vaginal prolapse to prevent one vaginal mesh extrusion . Neither serious adverse events nor deaths occurred in either group . CONCLUSION : Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at one year . However , quality of life and sexual symptoms scores improved in both groups . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00535301 LEVEL OF EVIDENCE : |
1,322 | 23,432,923 | It also led to improved exercise performance and enhancement of exercise rehabilitation programmes .
This systematic review and meta- analysis demonstrates that nutritional support in COPD results in significant improvements in a number of clinical ly relevant functional outcomes , complementing a previous review showing improvements in nutritional intake and weight | Currently , there is confusion about the value of using nutritional support to treat malnutrition and improve functional outcomes in chronic obstructive pulmonary disease ( COPD ) .
This systematic review and meta- analysis of r and omized , controlled trials ( RCT ) aim ed to clarify the effectiveness of nutritional support in improving functional outcomes in COPD . | Background COPD is a major cause of disability , but little is known about how disability develops in this condition . Methods The authors analysed data from the Function , Living , Outcomes and Work ( FLOW ) Study which enrolled 1202 Kaiser Permanente Northern California members with COPD at baseline and re-evaluated 1051 subjects at 2-year follow-up . The authors tested the specific hypothesis that the development of specific non-respiratory impairments ( abnormal body composition and muscle strength ) and functional limitations ( decreased lower extremity function , poor balance , mobility-related dyspnoea , reduced exercise performance and decreased cognitive function ) will determine the risk of disability in COPD , after controlling for respiratory impairment ( FEV1 and oxygen saturation ) . The Valued Life Activities Scale was used to assess disability in terms of a broad range of daily activities . The primary disability outcome measure was defined as an increase in the proportion of activities that can not be performed of 3.3 % or greater from baseline to 2-year follow-up ( the estimated minimal important difference ) . Multivariable logistic regression was used for analysis . Results Respiratory impairment measures were related to an increased prospect i ve risk of disability ( multivariate OR 1.75 ; 95 % CI 1.26 to 2.44 for 1 litre decrement of FEV1 and OR 1.57 per 5 % decrement in oxygen saturation ; 95 % CI 1.13 to 2.18 ) . Non-respiratory impairment ( body composition and lower extremity muscle strength ) and functional limitations ( lower extremity function , exercise performance , and mobility-related dyspnoea ) were all associated with an increased longitudinal risk of disability after controlling for respiratory impairment ( p<0.05 in all cases ) . Non-respiratory impairment and functional limitations were predictive of prospect i ve disability , above- and -beyond sociodemographic characteristics , smoking status and respiratory impairment ( area under the receiver operating characteristic curve increased from 0.65 to 0.75 ; p<0.001 ) . Conclusions Development of non-respiratory impairment and functional limitations , which reflect the systemic nature of COPD , appear to be critical determinants of disablement . Prevention and treatment of disability require a comprehensive approach to the COPD patient BACKGROUND Use of nutritional supplements in depleted patients with chronic obstructive pulmonary disease ( COPD ) requires optimization between positive effects on outcome and potential acute adverse effects on metabolism and exercise performance . OBJECTIVE The aim of this study was to investigate the acute effects of nutritional supplements on metabolism and exercise capacity in stable COPD patients . DESIGN In part 1 , the effects of 3 different energy loads ( placebo , 1046 kJ , and 2092 kJ ) with a normal distribution of macronutrients were investigated in 14 COPD patients . In part 2 , the effects of a fat-rich compared with a carbohydrate-rich supplement ( both 1046 kJ ) were studied in 11 COPD patients . The study was performed in a r and omized , double-blind , crossover fashion . Metabolic and ventilatory variables were measured postpr and ially and during a submaximal cycle endurance exercise test . RESULTS Overall , no immediate negative effects of the supplements were found in part 1 . A slight but significant postpr and ial increase in respiratory quotient was found after the 1046-kJ and 2092-kJ supplements compared with placebo . There was no significant difference in metabolism or exercise capacity after a fat-rich or carbohydrate-rich supplement . Surprisingly , the change in shortness of breath ( postpr and ial compared with prepr and ial ) was significantly greater after the fat-rich supplement . CONCLUSIONS An energy load up to 2092 kJ had no adverse immediate effect in COPD patients compared with placebo . The subjects who consumed the fat-rich supplement experienced more shortness of breath than did the subjects who consumed the carbohydrate-rich supplement The impact of oral nutritional supplementation during an acute exacerbation of COPD on functional status was assessed through measuring change in lung function , strength testing , and general well-being . Subjects hospitalized for an acute exacerbation of COPD ( n = 33 ) were r and omized to extra nutritional support or the regular hospital care . They consumed an additional 10 kcal/kg/d . Outcome measures were measured at 2 wk as change scores . Forced vital capacity ( % predicted ) improved in the treatment group as compared with the control group ( + 8.7 % versus -3.5 % , p = 0.015 ) , and change in FEV1 was in the same direction but not significantly different ( p = 0.099 ) . There were no changes in h and grip strength or respiratory muscle strength , but there was a trend towards more improvement in the general well-being score ( + 11.96 versus -10.25 , p = 0.066 ) . Almost all subjects were in negative nitrogen balance , indicating muscle wasting . The degree of muscle wasting was strongly correlated with the dose of corticosteroids ( r = 0.73 , p < 0.005 ) . In conclusion , it is difficult to prevent important muscle wasting in patients with COPD treated with corticosteroids , but some small gains were observed with increased dietary intake Background In chronic respiratory failure ( CRF ) , body composition strongly predicts survival . Methods A prospect i ve r and omised controlled trial was undertaken in malnourished patients with CRF to evaluate the effects of 3 months of home rehabilitation on body functioning and composition . 122 patients with CRF on long-term oxygen therapy and /or non-invasive ventilation ( mean ( SD ) age 66 ( 10 ) years , 91 men ) were included from eight respiratory units ; 62 were assigned to home health education ( controls ) and 60 to multimodal nutritional rehabilitation combining health education , oral nutritional supplements , exercise and oral testosterone for 90 days . The primary endpoint was exercise tolerance assessed by the 6-min walking test ( 6MWT ) . Secondary endpoints were body composition , quality of life after 3 months and 15-month survival . Results Mean ( SD ) baseline arterial oxygen tension was 7.7 ( 1.2 ) kPa , forced expiratory volume in 1 s 31 (13)% predicted , body mass index ( BMI ) 21.5 ( 3.9 ) kg/m2 and fat-free mass index ( FFMI ) 15.5 ( 2.4 ) kg/m2 . The intervention had no significant effect on 6MWT . Improvements ( treatment effect ) were seen in BMI ( + 0.56 kg/m2 , 95 % CI 0.18 to 0.95 , p=0.004 ) , FFMI ( + 0.60 kg/m2 , 95 % CI 0.15 to 1.05 , p=0.01 ) , haemoglobin ( + 9.1 g/l , 95 % CI 2.5 to 15.7 , p=0.008 ) , peak workload ( + 7.2 W , 95 % CI 3.7 to 10.6 , p<0.001 ) , quadriceps isometric force ( + 28.3 N , 95 % CI 7.2 to 49.3 , p=0.009 ) , endurance time ( + 5.9 min , 95 % CI 3.1 to 8.8 , p<0.001 ) and , in women , Chronic Respiratory Question naire ( + 16.5 units , 95 % CI 5.3 to 27.7 , p=0.006 ) . In a multivariate Cox analysis , only rehabilitation in a per- protocol analysis predicted survival ( HR 0.27 , 95 % CI 0.07 to 0.95 , p=0.042 ) . Conclusions Multimodal nutritional rehabilitation aim ed at improving body composition increased exercise tolerance , quality of life in women and survival in compliant patients , supporting its incorporation in the treatment of malnourished patients with CRF . Clinical Trial number NCT00230984 Nutritional depletion commonly occurs in patients with COPD , causing muscle wasting and impaired physiologic function . Two hundred seventeen patients with COPD participated in a placebo-controlled , r and omized trial investigating the physiologic effects of nutritional intervention alone ( N ) for 8 wk or combined with the anabolic steroid n and rolone decanoate ( N + A ) . N and rolone decanoate or placebo ( P ) was injected intramuscularly ( women , 25 mg ; men , 50 mg ) in a double-blind fashion on Days 1 , 15 , 29 , and 43 . Nutritional intervention consisted of a daily high caloric supplement ( 420 kcal ; 200 ml ) . Also , all patients participated in an exercise program . In the depleted patients , both treatment regimens induced a similar significant body weight gain ( 2.6 kg ) but different body compositional changes . Particularly in the last 4 wk of treatment , weight gain in the N group was predominantly due to an expansion of fat mass ( p < 0.03 versus P and N + A ) , whereas the relative changes in fat-free mass ( FFM ) and other measures of muscle mass were more favorable in the N + A group ( p < 0.03 versus P ) . Maximal inspiratory mouth pressure improved within both treatment groups in the first 4 wk of treatment , but after 8 wk only N + A was significantly different from P ( p < 0.03 ) . Nutritional supplementation in combination with a short course of anabolic steroids may enhance the gain in FFM and respiratory muscle function in depleted patients with COPD without causing adverse side effects The objective of the study was to further unravel the prognostic significance of body weight changes in patients with COPD . Two survival analyses were performed : ( 1 ) a retrospective study , including 400 patients with COPD none of whom had received nutritional therapy ; ( 2 ) a post hoc analysis of a prospect i ve study , including 203 patients with COPD who had participated in a r and omized placebo-controlled trial . There was no overlap between the patient groups . Baseline characteristics of all patients were collected on admission to a pulmonary rehabilitation center in stable clinical condition . In the prospect i ve r and omized placebo-controlled trial , the physiologic effects of nutritional therapy alone ( n = 71 ) or in combination with anabolic steroid treatment ( n = 67 ) after 8 wk was studied in patients with COPD prestratified into a depleted group and a nondepleted group . Mortality was assessed as overall mortality . The Cox proportional hazards model was used to quantify the relationship between the baseline variables age , sex , spirometry , arterial blood gases , body mass index ( BMI ) , smoking , and subsequent overall mortality . Additionally , the influence of treatment response on mortality was investigated in the prospect i ve study . The retrospective study revealed that low BMI ( p < 0.001 ) , age ( p < 0.0001 ) and low PaO2 ( p < 0.05 ) were significant independent predictors of increased mortality . After stratification of the group into BMI quintiles a threshold value of 25 kg/m2 was identified below which the mortality risk was clearly increased . In the prospect i ve study , weight gain ( > 2 kg/8 wk ) in depleted and nondepleted patients with COPD , as well as increase in maximal inspiratory mouth pressure during the 8-wk treatment , were significant predictors of survival . On Cox regression analysis weight change entered as a time-dependent covariate remained an independent predictor of mortality in addition to all variables that were entered in the retrospective study . The combined results of the two survival analyses provide evidence to support the hypothesis that body weight has an independent effect on survival in COPD . Moreover the negative effect of low body weight can be reversed by appropriate therapy in some of the patients with COPD Study objectives Patients with chronic obstructive pulmonary disease ( COPD ) have low exercise capacity and low content of high energetic phosphates in their skeletal muscles . The aim of the present study was to investigate whether creatine supplementation together with exercise training may increase physical performance compared with exercise training in patients with COPD . Design In a r and omized , double-blind , placebo-controlled study , 23 patients with COPD ( forced expiratory volume in one second [ FEV1 ] < 70 % of predicted ) were r and omized to oral creatine ( n = 13 ) or placebo ( n = 10 ) supplementation during an 8-week rehabilitation programme including exercise training . Physical performance was assessed by Endurance Shuttle Walking Test ( ESWT ) , dyspnea and leg fatigue with Borg CR-10 , quality of life with St George ’s Respiratory Question naire ( SGRQ ) . In addition , lung function test , artery blood gases , grip strength test , muscle strength and fatigue in knee extensors were measured . Results COPD patients receiving creatine supplementation increased their average walking time by 61 % ( ESWT ) ( p < 0.05 ) after the training period compared with 48 % ( p = 0.07 ) in the placebo group . Rated dyspnea directly after the ESWT decreased significantly from 7 to 5 ( p < 0.05 ) in the creatine group . However , the difference between the groups was not statistically significant neither in walking time nor in rated dyspnea . Creatine supplementation did not increase the health related quality of life , lung function , artery blood gases , grip strength and knee extensor strength/fatigue . Conclusions Oral creatine supplementation in combination with exercise training showed no significant improvement in physical performance , measured as ESWT , in patients with COPD compared with exercise training alone STUDY OBJECTIVES We hypothesized that endurance exercise training would reduce the degree of hyperinflation for a given level of exercise and thereby improve submaximal exercise endurance . METHODS Twenty-four patients with COPD ( mean FEV(1 ) , 36.4 + /- 8.5 % of predicted [ + /- SD ] ) undertook a high-intensity cycle ergometer exercise training program for 45 min , three times a week for 7 weeks . Before and after training , the patients performed both an incremental exercise test to maximum and a constant work rate ( CWR ) test on a cycle ergometer at 75 % of the peak work rate obtained in the pretraining incremental test . Ventilatory variables were measured breath-by-breath , and inspiratory capacity ( IC ) was measured every 2 min to assess changes in end-expiratory lung volume . RESULTS After training , the increase in peak oxygen uptake was not statistically significant ; however , the peak work rate increased by 12.9 + /- 10.3 W ( p < 0.01 ) . For the CWR test performed at the same work rate both before and after training , ventilation and breathing frequency ( f ) were lower after training ( average , 1.97 L/min and 3.2 breaths/min , respectively ; p < 0.01 ) and IC was greater ( by an average of 133 mL , p < 0.05 ) , signifying decreased hyperinflation . The increase in IC at the point of termination in the shortest CWR test for each individual ( defined as isotime ) correlated well with both the decreased f ( r = 0.63 , p = 0.001 ) and with the increase in CWR exercise endurance ( average , 13.1 min , r = 0.46 , p = 0.023 ) . CONCLUSIONS Exercise training in patients with severe COPD dramatically improves submaximal exercise endurance . Decreased dynamic hyperinflation may , in part , mediate the improvement in exercise endurance by delaying the attainment of a critically high inspiratory lung volume Background : Fat-free mass ( FFM ) depletion marks the imbalance between tissue protein synthesis and breakdown in chronic obstructive pulmonary disease ( COPD ) . To date , the role of essential amino acid supplementation ( EAAs ) in FFM repletion has not been fully acknowledged . A pilot study was undertaken in patients attending pulmonary rehabilitation . Methods : 28 COPD patients with dynamic weight loss > 5 % over the last 6 months were r and omized to receive EAAs embedded in a 12-week rehabilitation program ( EAAs group n = 14 ) , or to the same program without supplementation ( C group n = 14 ) . Primary outcome measures were changes in body weight and FFM , using dual X-ray absorptiometry ( DEXA ) . Results : At the 12th week , a body weight increment occurred in 92 % and 15 % of patients in the EAAs and C group , respectively , with an average increase of 3.8 ± 2.6 kg ( P = 0.0002 ) and −0.1 ± 1.1 kg ( P = 0.81 ) , respectively . A FFM increment occurred in 69 % and 15 % of EAAs and C patients , respectively , with an average increase of 1.5 ± 2.6 kg ( P = 0.05 ) and −0.1 ± 2.3 kg ( P = 0.94 ) , respectively . In the EAAs group , FFM change was significantly related to fasting insulin ( r2 0.68 , P < 0.0005 ) , C-reactive protein ( C-RP ) ( r2 = 0.46 , P < 0.01 ) , and oxygen extraction tension ( PaO2x ) ( r2 = 0.46 , P < 0.01 ) at end of treatment . These three variables were highly correlated in both groups ( r > 0.7 , P < 0.005 in all tests ) . Conclusions : Changes in FFM promoted by EAAs are related to cellular energy and tissue oxygen availability in depleted COPD . Insulin , C-RP , and PaO2x must be regarded as clinical markers of an amino acid-stimulated signaling to FFM accretion The study aim ed to estimate the cost-effectiveness of interdisciplinary community-based chronic obstructive pulmonary disease ( COPD ) management in patients with COPD . We conducted a cost-effectiveness analysis alongside a 2-yr r and omised controlled trial , in which 199 patients with less advanced airflow obstruction and impaired exercise capacity were assigned to the INTERCOM programme or usual care . The INTERCOM programme consisted of exercise training , education , nutritional therapy and smoking cessation counselling offered by community-based physiotherapists and dieticians and hospital-based respiratory nurses . All-cause re source use during 2 yrs was obtained by self-report and from hospital and pharmacy records . Health outcomes were the St George 's Respiratory Question naire ( SGRQ ) , exacerbations and quality -adjusted life years ( QALYs ) . The INTERCOM group had 30 % ( 95 % CI 3–56 % ) more patients with a clinical ly relevant improvement in SGRQ total score , 0.08 ( 95 % CI -0.01–0.18 ) more QALYs per patient , but a higher mean number of exacerbations , 0.84 ( 95 % CI -0.07–1.78 ) . Mean total 2-yr costs were € 2,751 ( 95 % CI -€632–€6,372 ) higher for INTERCOM than for usual care , which result ed in an incremental cost-effectiveness ratio of € 9,078 per additional patient with a relevant improvement in SGRQ or € 32,425 per QALY . INTERCOM significantly improved disease-specific quality of life , but did not affect exacerbation rate . The cost per QALY ratio was moderate , but within the range of that generally considered to be acceptable BACKGROUND & AIMS Previous studies reported a severely impaired energy balance in COPD patients during the first days of an acute exacerbation , mainly due to a decreased energy and protein intake . The aim of the study was to investigate the feasibility and effectiveness of energy- and protein-rich nutritional supplements during hospitalization for an acute exacerbation in nutritionally depleted COPD patients . METHODS In a r and omized double-blind , placebo-controlled two-center trial , 56 COPD patients were r and omized and 47 patients completed the study . Nutritional intervention consisted of 3 x 125 ml ( 2.38 MJ/day ) and the placebo group received similar amounts of a non-caloric fluid . Medical therapy and dietetic consultation were st and ardized and dietary intake was measured daily . Body composition , respiratory and skeletal muscle strength , lung function and symptoms were measured on admission and on days 4 and 8 of hospitalization . RESULTS Forty-seven percent of the patients had experienced recent involuntary weight loss prior to admission . The degree of weight loss was inversely related to resting arterial oxygen tension ( r = 0.31 ; P < 0.05 ) . Nutritional intervention result ed in a significant increase in energy ( 16 % vs. placebo ) and protein intake ( 38 % vs. placebo ) . Mean duration of hospitalization was 9 + /- 2 days . Relative to usual care , no additional improvements in lung function or muscle strength were seen after nutritional intervention . CONCLUSIONS Oral nutritional supplementation during hospitalization for an acute exacerbation is feasible in nutritionally depleted COPD patients and does not interfere with normal dietary intake BACKGROUND : High calorie intakes , especially as carbohydrate , increase carbon dioxide production ( VCO2 ) and may precipitate respiratory failure in patients with severe pulmonary disease . Energy obtained from fat results in less carbon dioxide and thus may permit a reduced level of alveolar ventilation for any given arterial blood carbon dioxide tension ( PaCO2 ) . METHODS : Ten patients with stable severe chronic obstructive lung disease underwent a six minute walk before and 45 minutes after taking 920 kcal of a fat rich drink , an isocalorific amount of a carbohydrate rich drink , and an equal volume of a non-calorific control liquid on three separate days , in a double blind r and omised crossover study . Borg scores of the perceived effort to breathe were measured at the beginning and end of each six minute walk . Minute ventilation ( VE2 ) , VCO2 , oxygen consumption ( VO2 ) , respiratory quotient ( RQ ) , arterial blood gas tensions , and lung function were measured before and 30 minutes after each test drink . RESULTS : Baseline measurements were similar on all three test days and the non-calorific control drink result ed in no changes in any of the measured variables . The carbohydrate rich drink result ed in significantly greater increases in VE , VCO2 , VO2 , RQ , PaCO2 , and Borg score and a greater fall in the distance walked in six minutes than the fat rich drink ( mean fall after carbohydrate rich drink 17 m v 3 m after fat rich drink and the non-calorific control ) . The increase in VCO2 correlated significantly with the decrease in six minute walking distance and the increase in Borg score after the carbohydrate rich drink . The only significant change after the fat rich drink when compared with the non-calorific control was an increase in VCO2 . CONCLUSIONS : Comparatively small changes in the carbohydrate and fat constitution of meals can have a significant effect on VCO2 , exercise tolerance , and breathlessness in patients with chronic obstructive lung disease Background : Skeletal muscle wasting and dysfunction are strong independent predictors of mortality in patients with chronic obstructive pulmonary disease ( COPD ) . Creatine nutritional supplementation produces increased muscle mass and exercise performance in health . A controlled study was performed to look for similar effects in 38 patients with COPD . Methods : Thirty eight patients with COPD ( mean ( SD ) forced expiratory volume in 1 second ( FEV1 ) 46 (15)% predicted ) were r and omised to receive placebo ( glucose polymer 40.7 g ) or creatine ( creatine monohydrate 5.7 g , glucose 35 g ) supplements in a double blind trial . After 2 weeks loading ( one dose three times daily ) , patients participated in an outpatient pulmonary rehabilitation programme combined with maintenance ( once daily ) supplementation . Pulmonary function , body composition , and exercise performance ( peripheral muscle strength and endurance , shuttle walking , cycle ergometry ) took place at baseline ( n = 38 ) , post loading ( n = 36 ) , and post rehabilitation ( n = 25 ) . Results : No difference was found in whole body exercise performance between the groups : for example , incremental shuttle walk distance mean −23.1 m ( 95 % CI −71.7 to 25.5 ) post loading and −21.5 m ( 95 % CI −90.6 to 47.7 ) post rehabilitation . Creatine increased fat-free mass by 1.09 kg ( 95 % CI 0.43 to 1.74 ) post loading and 1.62 kg ( 95 % CI 0.47 to 2.77 ) post rehabilitation . Peripheral muscle performance improved : knee extensor strength 4.2 N.m ( 95 % CI 1.4 to 7.1 ) and endurance 411.1 J ( 95 % CI 129.9 to 692.4 ) post loading , knee extensor strength 7.3 N.m ( 95 % CI 0.69 to 13.92 ) and endurance 854.3 J ( 95 % CI 131.3 to 1577.4 ) post rehabilitation . Creatine improved health status between baseline and post rehabilitation ( St George ’s Respiratory Question naire total score −7.7 ( 95 % CI −14.9 to −0.5 ) ) . Conclusions : Creatine supplementation led to increases in fat-free mass , peripheral muscle strength and endurance , health status , but not exercise capacity . Creatine may constitute a new ergogenic treatment in COPD RATIONALE Nutritional depletion is a common problem in chronic obstructive pulmonary disease ( COPD ) patients . It is caused , to a large extent , by an imbalance between low-energy intake and high-energy requirements . This problem adversely affects morbidity and mortality . However , the use of nutritional supplements to reach their energy necessities requires optimisation between positive and adverse effects on outcome before being used systematic ally as part of their comprehensive care . PURPOSE The aim of our study was to investigate the effects of oral nutritional repletion on quality of life in stable COPD patients . METHODS Prospect i ve , r and omised and multi-centre study . Stable COPD patients with a body mass index 22 , a fat-free mass index 16 , and /or a recent involuntary weight loss ( 5 % during last month , or 10 % during the last 3 months ) were studied . Exclusion criteria were to present signs of an airway infection , to have a cardiovascular , neurological , or endocrine disease , to be treated with oral steroids , immunosuppressors or oxygen therapy at home , and to receive nutritional supplements . During 12 weeks , patients were encouraged to ingest a total daily defined energy intake . R and omly , in patients from group A the total daily energy load was Resting Energy Expenditure (REE)x1.7 , and those from group B , REE x1.3 . Total daily energy intake was achieved with regular food plus , if necessary , oral nutritional supplement rich in proteins ( with 50 % of whey protein ) , with predominance of carbohydrates over fat , and enriched in antioxidants . Primary end-point variable was quality of life . Secondary end-point outcomes included body weight , body composition , lung function , h and grip strength , and compliance with the energy intake previously planned . Data were treated with a SAS System . Student 's test , Wilcoxon 's rank sum test , and Mann-Whitney 's test were used . RESULTS At baseline both groups of patients were comparable . All patients needed oral nutritional supplements to achieve total daily defined energy intake . After 12 weeks of follow-up , patients in both groups significantly increased energy intake . Patients in group A increased body weight ( P=0.001 ) , triceps skin fold thickness ( P=0.009 ) and body fat mass ( P=0.02 ) , and decreased body fat-free mass index ( P=0.02 ) . In this group a marked increase in airflow limitation was observed . A tendency to increase body weight and h and grip strength , and to decrease airflow limitation was observed in patients from group B. Furthermore , patients in the later group showed a significant improvement in the feeling of control over the disease ( P=0.007 ) and a tendency to better the other criteria in a quality of life scale . CONCLUSIONS According to our results , total daily energy intake of REE x 1.3 is preferable to REE x 1.7 in mild stable COPD patients . The administration of oral nutritional supplements , rich in proteins ( with 50 % of whey protein ) , with predominance of carbohydrates over fat , and enriched in antioxidants , to achieve total daily defined energy intake in patients in group B was followed by a significant improvement of one criteria ( mastery ) among many others in a quality of life scale RATIONALE Skeletal muscle strength and bulk are reduced in patients with chronic obstructive pulmonary disease ( COPD ) and influence quality of life , survival , and utilization of health care re sources . Exercise training during pulmonary rehabilitation ( PR ) can reverse some of these effects . In athletes and healthy elderly individuals , dietary creatine supplementation ( CrS ) has been shown to augment high-intensity exercise training , thereby increasing muscle mass . OBJECTIVES This article examines the effect of CrS on functional exercise capacity and muscle performance in people with COPD . METHODS One hundred subjects with COPD ( mean [ SD ] age , 68.2 [ 8.2 ] yr ; FEV(1 ) , 44.0 [ 19.6 ] % predicted ) were r and omized to a double-blind , placebo-controlled , parallel group trial of CrS during 7 weeks of PR encompassing aerobic and resistance exercises . Subjects ingested creatine ( 22 g/d loading for 5 d ; maintenance , 3.76 g/d throughout PR ) or placebo . Baseline , postloading , and postrehabilitation measurements included pulmonary function , body composition , peripheral muscle strength , and functional performance ( shuttle walking tests ) . A volunteer subgroup ( n = 44 ) had pre- and postloading quadriceps muscle biopsies . MEASUREMENTS AND MAIN RESULTS Eighty subjects completed the trial ( 38 creatine , 42 placebo ) . All outcome measures significantly improved after PR . There were no significant differences between groups post-PR ( mean [ SD ] change in incremental shuttle walk distance , 84 [ 79 ] m in the creatine group vs. 83.8 [ 60 ] m in the placebo group ; P = 1.0 ; knee extensor work , 19.2 [ 16 ] Nm [ Newton meters ] in the creatine group vs. 19.5 [ 17 ] Nm in the placebo group ; P = 0.9 ) . Muscle biopsies showed evidence of creatine uptake . CONCLUSIONS This adequately powered , r and omized , placebo-controlled trial shows that CrS does not augment the substantial training effect of multidisciplinary PR for patients with COPD . Clinical trial registered with https://portal.nihr.ac.uk/Pages/NRRArchive Search .aspx ( NO123138126 ) Pressurized whey supplementation , by its antioxidant and nutritional properties , may improve exercise tolerance and potentiate the effects of exercise training in patients with chronic obstructive pulmonary disease ( COPD ) . In this r and omized , double-blind , placebo-controlled study , 22 patients with COPD were allocated to receive active pressurized whey or placebo ( casein ) dietary supplementation for a 16-week period . Patients continued their usual physical activities for the first 8 weeks , whereas they were subjected to an exercise training program for the remaining 8 weeks of the study . Patients were evaluated at baseline , after 8 weeks of supplementation alone ( time point , 8 weeks ) , and after 8 weeks of its combination with exercise training ( time point , 16 weeks ) . The constant workrate cycle endurance test ( CET ) , potentiated quadriceps twitch force , mid-thigh cross-sectional area , and Chronic Respiratory Question naire ( CRQ ) were used to evaluate the effects of treatments . The inflammatory ( C-reactive protein and interleukin-6 ) and oxidant/antioxidant ( protein oxidation and glutathione ) blood profiles were also characterized . At week 8 , there was no increase in CET time in either group . At week 16 , there was a statistically significant increase in CET time in the whey-only group ( P < .05 ) . Further , at week 16 , there was clinical ly significant improvement in the Dyspnea and the Mastery scales of the CRQ in both groups . Also , the Fatigue and Emotional Control scales of the CRQ showed clinical ly significant improvement in the whey-only group . Study interventions did not modify significantly the systemic inflammatory and oxidative stress markers that were assessed . Thus dietary supplementation with pressurized whey may potentiate the effects of exercise training on exercise tolerance and quality of life in patients with COPD UNLABELLED Dietary intervention studies in COPD patients often are short-term inpatient studies where a certain amount of extra energy is guaranteed . The aim of this study was to evaluate the effect of an 1 year individual multifaceted dietary intervention during multidisciplinary rehabilitation . Eighty-seven patients with severe COPD , not dem and ing oxygen therapy were included , 24 of them served as controls . A dietary history interview was performed at baseline and at study end . Dietary advice given were based on results from the dietary history and socio-economic status . The intervention group was divided into three parts ; NW : normal weight ( dietary advice given aim ing to weight maintenance ) , OW : overweight ( weight-reducing advice ) and UW : underweight ( dietary advise based on an energy- and protein-rich diet ) . RESULTS UW-group : Eighty-one per cent of the patients gained weight or kept a stable weight . OW-group : Fifty-seven per cent lost more than 2 kg NW-group : Seventy-six per cent kept a stable weight or gained weight . Increased dietary intake from baseline was seen for energy protein , carbohydrates and certain micronutrients ( P < 0.05 ) in the UW group . Six minutes walking distance increased by approximately 20 m in both NW ( P < 0.05 ) and UW patients . To conclude , slight , but uniform , indications of positive effects of dietary intervention during multidisciplinary rehabilitation was seen . Dietary intervention in underweight COPD patients might be a prerequisite for physical training In a r and omized , double-blinded study , patients with chronic obstructive pulmonary disease and hypercapnia were fed low , moderate , and high carbohydrate diets to determine the effect on metabolic and ventilatory values . The low carbohydrate diet consisted of 28 % carbohydrate calories and 55 % fat calories and result ed in significantly lower production of CO2 ( p less than 0.002 ) , respiratory quotient ( p less than 0.001 ) , and arterial Pco2 ( p less than 0.05 ) . At the end of the 15-day study , both the forced vital capacity ( p less than 0.05 ) and the forced expiratory volume in 1 second ( p less than 0.05 ) had improved by 22 % over baseline values . Total calories given surpassed daily caloric requirements . This approach , together with a low carbohydrate , high fat mixture , may be beneficial for such patients STUDY OBJECTIVE To evaluate the influence of oral anabolic steroids on body mass index ( BMI ) , lean body mass , anthropometric measures , respiratory muscle strength , and functional exercise capacity among subjects with COPD . DESIGN Prospect i ve , r and omized , controlled , double-blind study . SETTING Pulmonary rehabilitation program . PARTICIPANTS Twenty-three undernourished male COPD patients in whom BMI was below 20 kg/m2 and the maximal inspiratory pressure ( PImax ) was below 60 % of the predicted value . INTERVENTION The study group received 250 mg of testosterone i.m . at baseline and 12 mg of oral stanozolol a day for 27 weeks , during which time the control group received placebo . Both groups participated in inspiratory muscle exercises during weeks 9 to 27 and cycle ergometer exercises during weeks 18 to 27 . MEASUREMENTS AND RESULTS Seventeen of 23 subjects completed the study . Weight increased in nine of 10 subjects who received anabolic steroids ( mean , + 1.8+/-0.5 kg ; p<0.05 ) , whereas the control group lost weight ( -0.4+/-0.2 kg ) . The study group 's increase in BMI differed significantly from that of the control group from weeks 3 to 27 ( p<0.05 ) . Lean body mass increased in the study group at weeks 9 and 18 ( p<0.05 ) . Arm muscle circumference and thigh circumference also differed between groups ( p<0.05 ) . Changes in PImax ( study group , 41 % ; control group , 20 % ) were not statistically significant . No changes in the 6-min walk distance or in maximal exercise capacity were identified in either group . CONCLUSION The administration of oral anabolic steroids for 27 weeks to malnourished male subjects with COPD was free of clinical or biochemical side effects . It was associated with increases in BMI , lean body mass , and anthropometric measures of arm and thigh circumference , with no significant changes in endurance exercise capacity Background : Malnutrition in chronic obstructive pulmonary disease ( COPD ) is associated with a poor prognosis , yet evidence to support the role of dietary counselling and food fortification is lacking . A study was undertaken to assess the impact of dietary counselling and food fortification on outcome in out patients with COPD who are at risk of malnutrition . Methods : A r and omised controlled unblinded trial was performed in 59 out patients with COPD ( 6 months intervention and 6 months follow-up ) . The intervention group received dietary counselling and advice on food fortification and the controls received a dietary advice leaflet . Outcome measures were nutritional status , respiratory and skeletal muscle strength , respiratory function , perceived dyspnoea , activities of daily living ( ADL ) and quality of life . Results : The intervention group consumed more energy ( difference 194 kcal/day ; p = 0.02 ) and protein ( difference 11.8 g/day ; p<0.001 ) than controls . The intervention group gained weight during the intervention period and maintained weight during follow-up ; the controls lost weight throughout the study . Significant differences were observed between the groups in St George ’s Respiratory Question naire total score ( difference 10.1 ; p = 0.02 ) , Short Form-36 health change score ( difference 19.2 ; p = 0.029 ) and Medical Research Council dyspnoea score ( difference 1.0 ; p = 0.03 ) ; the difference in ADL score approached statistical significance ( difference 1.5 ; p = 0.06 ) . No differences were observed between groups in respiratory function or skeletal and respiratory muscle strength . Improvements in some variables persisted for 6 months beyond the intervention period . Conclusion : Dietary counselling and food fortification result ed in weight gain and improvements in outcome in nutritionally at-risk out patients with COPD , both during and beyond the intervention period The association between severe nutritional depletion and chronic obstructive pulmonary disease ( COPD ) has long been recognized . A potential therapeutic benefit to nutritional support was previously suggested by us in a pilot investigation . Subsequent studies have reported conflicting results regarding the role of nutritional therapy in this clinical population . We report a r and omized controlled study of nutritional therapy in underweight patients with COPD that combines an initial inpatient investigation ( controlled nutritional support ) with a prolonged outpatient follow-up interval . Provision of adequate calorie and protein support , adjusted to metabolic requirements , result ed in weight gain ( intervention = + 2.4 kg versus control -0.5 kg ) , improved h and grip strength ( intervention = + 5.5 kg-force versus control -6.0 kg-force ) , expiratory muscle strength ( intervention = + 14.9 cm H2O versus control -9.2 cm H2O ) , and walking distance ( intervention = + 429 feet versus control -1.0 foot ) . Inspiratory muscle strength was also improved ( intervention = + 11.4 cm H2O versus control + 4.8 cm H2O ) although this did not quite reach statistical significance . We conclude that provision of adequate nutrient supply under controlled conditions results in significant clinical improvements in the COPD patient population . However , the intervention is costly , time-intensive , and of limited therapeutic magnitude . More detailed work of alternative outpatient strategies combined with additional rehabilitative measures is indicated to delineate the full therapeutic potential of nutritional support for this clinical population Background : Undernutrition in hospitalized patients is often not recognized and nutritional support neglected . Chronic obstructive pulmonary disease is frequently characterized by weight loss . No data exist on the effects of nutritional supplementation in underweight lung transplantation c and i date s during hospitalization . Objective : To evaluate the effects on energy intake and body weight of an intensified nutritional support compared to the regular support during hospitalization . Methods : The participants were underweight ( n = 42 ) and normal-weight ( n = 29 ) patients with end-stage pulmonary disease assessed for lung transplantation . The underweight patients were r and omized to receive either an energy-rich diet planned for 10 MJ/day and 45–50 energy percentage fat and offered supplements ( group 1 ) , or the normal hospital diet planned for 8.5–9 MJ/day and 30–35 energy percentage fat and regular support ( group 2 , control group ) . The normal-weight control patients ( group 3 ) received the normal diet . Food intake was recorded for 3 days . Results : During a mean hospital stay of 12 days , the energy intake was significantly greater for the patients on intensified nutritional support ( median 11.2 MJ ) than for the underweight patients on the regular support ( 8.4 MJ ; p < 0.02 ) and the normal-weight patients ( 7.0 MJ ; p < 0.001 ) . The increase in energy intake in group 1 result ed in a significant weight gain ( median 1.2 kg ) compared with group 2 ( p < 0.01 ) and group 3 ( p < 0.001 ) . Conclusions : In a group of underweight patients with lung disease assessed for lung transplantation , it was possible to increase energy intake by an intensified nutritional support which was associated with a significant weight gain , compared to the regular nutritional support during a short hospital stay Patients with chronic obstructive pulmonary disease ( COPD ) often suffer from weight loss . The aim of the present study was to gain insight into the energy balance of depleted ambulatory COPD patients , in relation to their habitual level of physical activity and consumption of oral nutritional supplements . Clinical ly stable and weight-stable patients ( n 20 ; BMI 19.8+/- SD 2.0 kg/m2 ) were studied 1 and 3 months after rehabilitation or recovery in the clinic and were at r and om assigned to a control or intervention group with regard to nutritional supplementation . Energy intake was measured with a 7 d food record . Energy expenditure was estimated from a simultaneous 7 d assessment of physical activity with a tri-axial accelerometer for movement registration in combination with measured BMR . Body mass was measured at several time points . The body mass remained stable in both groups after 1 or 3 months and mean energy balances were comparable for both groups . The mean body-mass change between month 1 and 3 was negatively related to the mean physical activity level ( r -0.49 ; P=0.03 ) . Weight change over the 3 months was negatively associated with the physical activity level . These results suggest that knowledge about the individual physical activity level is necessary for the estimation of the energy need of the COPD patient We examined the effect of nutritional supplementation for 13 wk on anthropometric , pulmonary function , and immunological status in malnourished ambulant patients with pulmonary emphysema ( EP ) . The study was placebo controlled , r and omized and double blind . Twenty-eight patients were included . Thirteen patients in the fed group were provided with a nutritional formula providing 20 % protein , 30 % fat , and 50 % carbohydrate , 1 Kcal/ml , 400 ml/day . The control group was provided with a reference product of the same consistency and taste containing 0.1 Kcal/ml , 400 ml/day for 13 wk . The fed group had a mean weight gain of 1.5 kg during the study period , the control group increased concomitantly 0.16 kg , the difference being significant ( p less than 0.01 ) . Sum of four skinfolds increased 2.7 mm in the fed group , and decreased 0.9 mm in the control group the difference being significant ( p less than 0.01 ) . No difference were observed regarding pulmonary function or immunological status . We also found a high habitual energy intake in our study group ( 204 % Basal Energy Expenditure ) . We conclude that nutritional supplementation produce weight gain in malnourished patients with EP , but it does not change other indices of well-being BACKGROUND Enteral tube and parenteral hyperalimentation are widely used nutritional support systems . Few studies examine the relation between nutritional support and patient outcomes in seriously ill hospitalized adults . OBJECTIVE To explore the association between nutritional support and survival in seriously ill patients enrolled in the Study to Underst and Prognoses and Preferences for Outcomes and Risks of Treatments ( SUPPORT ) . DESIGN A prospect i ve study of preferences , decision-making , and outcomes . SETTING Five teaching hospitals PARTICIPANTS 6298 patients aged 18 or older meeting diagnostic and illness severity criteria . MEASUREMENT Demographic characteristics , diagnoses , comorbid conditions , acute physiology score , nutritional support , and functional status before hospitalization . RESULTS A total of 2149 patients received nutritional support . In patients who received artificial nutrition on hospital days 1 or 3 ( Cohort 1 ) , enteral feeding was associated with improved survival in coma ( hazard : 0.53 ; 95%CI , 0.42 - 0.66 ) , and reduced survival in COPD ( hazard : 1.57 ; 95%CI , 1.18 - 2.08 ) . In patients who were hospitalized on Day 7 and received artificial nutrition on days 1 , 3 , or 7 ( Cohort 2 ) , enteral tube feeding ( hazard : 0.35 ; 95%CI , 0.27 - 0.46 ) or hyperalimentation ( hazard : 0.58 ; 95%CI , 0.38 - 0.90 ) was associated with improved survival in coma . Tube feeding was associated with decreased survival in acute respiratory failure ( ARF ) or multiorgan system failure ( MOSF ) with sepsis ( hazard : 1.21 ; 95%CI , 10.4 - 1.41 ) , cirrhosis ( hazard : 2.15 ; 95%CI , 1.35 - 3.42 ) , and COPD ( hazard : 1.37 ; 95%CI , 1.04 - 1.80 ) . Hyperalimentation was associated with decreased survival in ARF or MOSF with sepsis ( hazard : 1.34 ; 95%CI , 1.12 - 1.59 ) . CONCLUSIONS Nutritional support was associated with improved survival in coma . Enteral feeding and hyperalimentation was associated with decreased survival in ARF or MOSF with sepsis . Tube feeding was associated with decreased survival in cirrhosis and COPD . Except for patients in coma , artificial nutrition was not associated with a survival advantage Background : Weight loss and skeletal muscle wasting are common in patients with chronic obstructive pulmonary disease ( COPD ) and can influence the course and the prognosis of COPD . Hypophosphatemia is a pathologic status often characterized by muscle weakness and is a frequent laboratory finding in these patients . Objective : The aim of the present study was to evaluate the effect of an organic phosphate ( fructose 1,6-diphosphate , FDP ) administration on respiratory performance in 45 malnourished COPD patients in stable clinical conditions . Methods : Physiologic evaluation including spirometry , maximal voluntary ventilation ( MMV ) , elevated arm test , maximal mouth pressures ( PImax and PEmax ) , respiratory response to CO2 , oxygen ( PaO2 ) and carbon dioxide ( PaCO2 ) arterial tension , a visual analogic scale ( VAS ) to measure dyspnea , and complete blood tests were done at the beginning and again at the end of the study . Results : After FDP administration , there was a significant increase in PImax ( 43.0 ± 18.3 cm H2O before treatment vs. 49.8 ± 14.9 cm H2O after treatment ; p < 0.005 ) . This did not occur in the placebo group ( 40.3 ± 17.4 cm H2O before treatment vs. 42.6 ± 20.1 cm H2O after treatment , nonsignificant ) . There was also a trend of VAS to decrease and of MVV to increase . Conclusions : These results show that FDP administration may be useful in the management of malnourished COPD patients , especially in increasing their respiratory muscle strength We carried out a prospect i ve r and omized controlled trial to investigate the effects of short-term refeeding ( 16 days ) in 10 malnourished in patients with chronic obstructive pulmonary disease ( COPD ) . Six patients were r and omized to receive sufficient nasoenterically administered calories to provide a total caloric intake equal to 1,000 kcal above their usual intake . The other four patients were sham fed , receiving only 100 kcal more . Measurements of nutritional status , respiratory muscle strength and endurance , adductor pollicis function , and pulmonary function were performed initially and at study end . The refed group gained significantly more weight and showed significant increases in maximal expiratory pressure and mean sustained inspiratory pressure . There were no significant changes in the maximal inspiratory pressure or in adductor pollicis function . In malnourished in patients with COPD , short-term refeeding leads to improvement in respiratory muscle endurance and in some parameters of respiratory muscle strength in the absence of demonstrable changes in peripheral muscle function We examined the effect of nutritional supplementation for 8 wk on respiratory muscle function ( RMF ) in 21 malnourished patients with COPD . Patients were r and omized to a fed group or to a control group . Patients in the fed group were provided with an enteral formula in addition to their usual diet . Daily calorie and protein intake and weekly anthropometric measures were made . Pulmonary function tests were measured on Weeks 1 , 4 , and 8 . Respiratory muscle strength was measured by means of maximal inspiratory and expiratory pressures ( MIP ) , ( MEP ) , and respiratory muscle endurance was measured by the maximal sustained ventilatory capacity ( MSVC ) . The mean weight of the fed group increased from 52.2 + /- 6.4 to 53.3 + /- 6.9 kg ( NS ) . The mean daily caloric intake of the fed group was significantly increased during the study ( p less than 0.02 ) . The mean calorie intake during the study of the fed group was 174 + /- 17 % of the estimated basal energy expenditure . During the study period , no change was observed in anthropometric measures , pulmonary function studies , or RMF . Because patients tend to decrease their own food intake while receiving enteral formulas , it is difficult to provide sufficient calories and protein needed to effect changes in nutritional status and RMF in an outpatient COPD population . In addition , we compared RMF in 12 poorly nourished male patients ( 87.6 + /- 6.1 % of ideal body weight ) and 13 well-nourished male patients with severe COPD . Both groups had comparable degrees of air-flow limitation and hyperinflation . No difference was noted between the groups in either MIP , MEP , or MSVC . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND A low body mass index ( BMI ) has been shown to be an independent indicator of poor prognosis in patients with COPD . However , some studies suggest that muscle mass depletion ( MD ) is the main factor responsible for the negative effects attributable to malnutrition . STUDY OBJECTIVE To evaluate the prognostic influence of MD estimated from anthropometric parameters . DESIGN AND MEASUREMENTS Mortality was studied in a prospect i ve cohort of 96 male patients with COPD ( average age , 69 + /- 9 years ; FEV1 percentage of predicted , 44 + /- 18 % [ + /- SD ] ) followed up for 3 years , with an evaluation of the prognostic influence of the following anthropometric parameters : BMI , mid-arm muscle area ( MAMA ) , and fat-free mass index . Other risk factors were also analyzed , such as age , comorbidity ( Charlson index ) , basal dyspnea index , the St. George 's Respiratory Question naire score , the number of hospital admissions in the year prior to nutritional evaluation , the number of hospital admissions in the year immediately after nutritional evaluation ( Hpost ) , spirometry , and blood gases . RESULTS In the multivariate study , Pa(CO2 ) ( p = 0.003 ; hazard ratio , 1.08 ) , Hpost ( p = 0.005 , hazard ratio , 4.63 ) , and a MAMA value less than or equal to percentile 25 of the reference value ( p25 ) [ p = 0.025 ; hazard ratio , 3.78 ] were found to be independent indicators of poor prognosis . Respiratory mortality after 12 , 24 , and 36 months in the patients with MAMA < or = p25 was 12.1 % , 31.4 % , and 39.2 % , respectively , vs 5.9 % , 7.9 % , and 13 % in the group of patients without MD ( p = 0.006 ) . In normal-weight or overweight patients , MAMA < or = p25 increased the risk of mortality 3.4-fold ( p = 0.032 ) . CONCLUSIONS MD is a better predictor of mortality than BMI in patients with COPD , fundamentally in normal-weight or overweight patients . The prognostic influence of MD can be estimated indirectly by determining the MAMA , an inexpensive , simple , and rapidly obtained anthropometric measure We carried out a prospect i ve , r and omized , controlled trial to investigate the effect of a 3-month period of supplementary oral nutrition in 14 poorly nourished out patients with COPD . Seven patients were r and omized into Group 1 who received their normal diet during Months 1 to 3 , a supplemented diet during Months 4 to 6 , and their original normal diet during Months 7 to 9 . The other 7 patients received their normal diet for the entire 9-month study period ( Group 2 ) . Seven well-nourished patients ( Group 3 ) matched for age and severity of air-flow obstruction served as control subjects ; they received their normal diet for the 9-month study period . Measurements of nutritional status , respiratory muscle and h and grip strength , sternomastoid muscle function ( including frequency/force curves , maximal relaxation rate , and a fatigability test ) , lung function , arterial blood gas tensions , general well-being and breathlessness scores , and 6-min walking distances were carried out monthly in all patients . At the start of the study , the poorly nourished patients had lower mean daily calorie and protein intakes than did the well-nourished patients . The poorly nourished patients had lower respiratory muscle and h and grip strength , and abnormal contractility and increased fatigability of the sternomastoid muscle compared with those in the well-nourished patients . After 3 months of supplementary oral nutrition , there was a significant improvement in the nutritional status of Group 1 patients , as evidence d by an increase in body weight , triceps skinfold thickness , and midarm muscle circumference . Respiratory muscle and h and grip strength increased in parallel with nutritional status , although there were no significant changes in lung function or arterial blood gas tensions . ( ABSTRACT TRUNCATED AT 250 WORDS High fat enteral formulas have been advocated for the nutritional support of chronic obstructive pulmonary disease ( COPD ) patients because dietary fat utilization under ideal conditions produces less CO2 per O2 consumed than carbohydrate . No data exist for these patients comparing the effects of a moderate fat vs. a high fat enteral formula on gastric emptying times ( GE ) and subsequent CO2 production ( VCO2 ) , oxygen consumption ( VO2 ) , respiratory quotient ( RQ ) , and pulmonary function . Our double-blind crossover study compared these parameters after feeding a 355 mL ( 530 kcal ) meal with either 41 % fat calories ( Respalor ) or 55 % fat calories ( Pulmocare ) . Thirty-six COPD out patients with a forced expiratory volume in 1 s ( FEV1 ) < 60 % of predicted were studied after an overnight fast . Gastric emptying half-time ( GE t1/2 ) was measured using the 99MTc-radionuclide technique ; VCO2 , VO2 , RQ , and other pulmonary functions were measured at 0 , 30 , 90 , and 150 min postpr and ial using the Canopy Mode of the Deltatrac Metabolic Monitor and the Renaissance Spirometry System . We observed a significantly ( p = 0.0001 ) longer GE t1/2 of the high fat meal when compared to the moderate fat meal ( 134.1 vs. 108.6 min ) At 30 and 90 , but not at 150 min postpr and ial , the VCO2 and VO2 for patients fed the moderate-fat formula were significantly ( p = 0.05 ) higher than for those fed the high-fat formula ; no differences were observed for the other pulmonary functions . Although RQ increased significantly ( p = 0.01 ) after both meals , no differences between formulas were noted at all postpr and ial times tested . Compared to the high-fat meal , the moderate-fat meal significantly enhanced gastric emptying . The earlier rise in VCO2 and VO2 after the moderate-fat meal did not impact pulmonary function and reflected the earlier utilization of the moderate-fat meal . The fact that RQ was not different between the two meals at all postpr and ial times tested suggest that the higher rise in VCO2 and VO2 after the moderate-fat meal was most likely due to earlier gastric emptying of the moderate-fat meal rather than the difference of the fat-to-carbohydrate ratio between the two tested meals . The impact of these findings on long-term management of COPD patients awaits long-term prospect i ve studies AIM To assess prospect ively the effects of a controlled program of inspiratory muscle training program and nutritional support in patients with chronic obstructive lung disease ( COPD ) . PATIENTS AND METHODS Twenty-three patients with COPD were r and omly assigned into four groups . Group I received a 1000 kcal/day nutritional supplement , given as a casein based enteral nutritional formula ; group III was subjected to inspiratory muscle training , using an inexpensive pressure threshold load valve constructed according to the Appropriate Technology principles of the WHO , adjusted at 30 % of Maximal Inspiratory Mouth Pressure and received also the nutritional supplement ; group IV was trained but did not receive the nutritional supplement and group II was not trained nor supplemented . Patients were studied during three months and monthly , inspiratory muscle function , exercise capacity and anthropometry were measured . RESULTS A significant improvement in exercise capacity , maximal inspiratory pressure and inspiratory muscle endurance was observed in the four groups throughout the study . Trained subjects had greater improvement in their inspiratory muscle endurance , compared to untrained subjects . Nutritional support had no effect in inspiratory muscle function or exercise capacity . No changes in anthropometric measures were observed . CONCLUSIONS The pressure threshold load valve used in this study , improved inspiratory muscle endurance and nutritional support had no effect in patients with COPD AIM The aim of this study was to assess the usefulness of a lipid formulation containing a physical mixture of medium ( MCT ) and long chain triglycerides ( LCT ) compared with a long chain triglycerides emulsion in patients affected by chronic obstructive pulmonary disease with acute respiratory failure . METHODS Twenty-four patients requiring mechanical ventilation were r and omly selected in 2 groups and received total parenteral nutrition . Twelve patients received a MCT/LCT emulsion ( 50:50 ) , the others used a 100 % LCT emulsion . Nutritional status , metabolic rate , time of ventilatory support and weaning were evaluated . RESULTS Both groups showed an improvement of all nutritional parameters evaluated ; oxygen uptake , carbon dioxide output and respiratory gas exchange ratio were similar in both groups . The duration of mechanical ventilation was not significantly different ; however , the time of weaning in the MCT/LCT group was significantly shorter . The longer weaning time in the LCT group patients could be related to vasoactive intermediates deriving from long chain fatty acids . The T-cell subsets , which were evaluated for both groups , showed a significant decrease of T helper-T suppressor ratio in the LCT group . CONCLUSION MCT/LCT emulsion is an effective lipid supplementation and should be considered the therapy of choice in COPD patients ; however , the relationship between lipid emulsions administered and length of weaning requires further investigations We studied the effects of oral nutritional supplementation on respiratory muscle ( RM ) performance in 25 ambulatory patients with severe chronic obstructive pulmonary disease ( COPD ) . There was a relationship between body weight and anthropometric parameters of nutritional status ( triceps skinfold thickness [ r = 0.67 ; p less than 0.005 ] , midarm muscle circumference ( r = 0.53 ; p less than 0.005 ) , but body weight did not correlate with daily caloric intake , serum albumin , transferrin , or blood lymphocyte count . None of these measurements of nutritional status correlated with any measure of RM strength or endurance . In a r and omized observer-blinded crossover trial , patients were allocated to one of two groups . In the first eight weeks of the study , group A received nutritional supplementation , and patients in group B were control subjects . In the second eight weeks , patients in group A were control subjects , and group B received supplement . Mean daily caloric intake and body weight increased in both groups while receiving supplement ( both p less than 0.05 ) . Calories provided by the supplement were frequently substituted for normal dietary calories . Any increases in RM performance in the group receiving supplement were matched by increases ( due to learning ) in controls . We conclude that oral dietary supplements have no important effects on RM performance in ambulatory patients with COPD OBJECTIVE One of the goals in treating patients with chronic obstructive pulmonary disease ( COPD ) who suffer from hypoxemia , hypercapnia , and malnutrition is to correct the malnutrition without increasing the respiratory quotient and minimize the production of carbon dioxide . This 3-wk study evaluated the efficacy of feeding a high-fat , low-carbohydrate ( CHO ) nutritional supplement as opposed to a high-carbohydrate diet in COPD patients on parameters of pulmonary function . S METHODS : Sixty COPD patients with low body weight ( < 90 % ideal body weight ) were r and omized to the control group , which received dietary counseling for a high-CHO diet ( 15 % protein , 20 % to 30 % fat , and 60 % to 70 % CHO ) , or the experimental group , which received two to three cans ( 237 mL/can ) of a high-fat , low-CHO oral supplement ( 16.7 % protein , 55.1 % fat , and 28.2 % CHO ) in the evening as part of the diet . Measurements of lung function ( forced expiratory volume in 1 s or volume of air exhaled in 1 s of maximal expiration , minute ventilation , oxygen consumption per unit time , carbon dioxide production in unit time , and respiratory quotient ) and blood gases ( pH , arterial carbon dioxide tension , and arterial oxygen tension ) were taken at baseline and after 3 wk . RESULTS Lung function measurements decreased significantly and forced expiratory volume increased significantly in the experimental group . CONCLUSION This study demonstrates that pulmonary function in COPD patients can be significantly improved with a high-fat , low-CHO oral supplement as compared with the traditional high-CHO diet STUDY OBJECTIVES The first aim of this study was to investigate the effects of nutritional supplementation combined with low-intensity exercise on body components , exercise tolerance , and health-related quality of life ( HRQOL ) in malnourished patients with COPD . The second aim of this study was to examine the degree of systemic inflammation and the actual changes in levels of systemic CRP , TNFα , IL-6 and IL-8 actual changes after a combination of nutritional supplementation and low-intensity exercise in these patients . DESIGN A prospect i ve r and omized trial . PATIENTS Thirty-two moderate to severe , clinical ly stable malnourished COPD patients . METHODS Patients were r and omly divided into a nutritional supplementation with low-intensity exercise group and a control group . Lung function , maximum inspiratory and expiratory muscle force , the Chronic Respiratory Disease Question naire ( CRQ ) , the 6-min walking distance ( 6MWD ) , and the Borg scale were measured at baseline and were re-assessed at 3 months after intervention . The degree of systemic inflammation and the changes in levels of systemic CRP , TNFα , IL-6 and IL-8 were assessed before and after a combination nutritional supplementation with low-intensity exercise . RESULTS Body weight and FFM increased significantly after 12 weeks of nutritional supplementation therapy in patients with COPD . The dietary intake energy increased and the REE : REEpred ratio decreased significantly in the nutrition with low-intensity exercise group . PI(max ) , Quadriceps muscle force and the 6-min walking distance ( 6MWD ) increased significantly from baseline through week 12 . Health status , as assessed by CRQ , improved in the domains of dyspnea and total sores significantly in the nutrition with low-intensity exercise group after intervention . In this group , hsCRP , IL-6 , IL-8 , and TNFα , decreased significantly after intervention compared with the control group . CONCLUSIONS The combination of nutritional supplementation with low-intensity exercise training was successful in increasing weight and energy intake as well as exercise capacity and health-related QOL in our patients . Moreover , REE and major inflammatory cytokines decreased significantly after nutritional supplementation with low-intensity exercise training . The present study results suggest a potential role for the combination of nutritional supplementation and low-intensity exercise in the management of malnourished patients with COPD RATIONALE Limited data are available on effectiveness and costs of nutritional rehabilitation for patients with COPD in community care . METHODS In a 2-year RCT , 199 COPD patients ( FEV(1)%pred . 60 % [ SD 16 % ] ) and impaired exercise capacity were r and omized to the interdisciplinary community-based COPD management program ( INTERCOM ) or usual care ( UC ) . A prescheduled subgroup analysis was performed on 39 of 199 patients who were muscle wasted and received UC or nutritional therapy in combination with exercise training . Body composition , muscle strength , and exercise capacity were assessed at baseline and 4 , 12 , and 24 months . RESULTS Between group differences after 4 months in favor of the intervention group : fat free mass index ( FFMI 0.9 kg/m(2 ) [ SE = 0.2 , P < .001 ] ) , body mass index ( BMI 1.0 kg/m(2 ) [ SE = 0.4 , P = .009 ] ) , maximum inspiratory mouth pressure ( Pimax 1.4 kPa [ SE = 0.5 , P = .011 ] ) , quadriceps average power ( QAP 13.1 Watt [ SE=5.8 , P = .036 ] ) , 6-minute walking distance ( 6MWD 27 m , [ SE = 11.5 , P = .028 ] ) , cycle endurance time ( CET 525 seconds [ SE=195 , P = .013 ] ) , and peak exercise capacity ( Wmax 12 Watt [ SE = 5 , P = .036 ] ) . Between group difference over 24 months in favor of the intervention group : Pimax 1.7 kPa ( SE = 0.53 , P = .004 ) , QAP 19 Watt ( SE = 6 , P = .005 ) , 6MWD 57 ( SE = 19 , P = .006 ) , and CET 485 seconds ( SE = 159 , P = .006 ) . After 4 months total costs were Euro 1501 higher in the intervention group than in the UC group ( P < .05 ) , but not significantly different after 24 months . Hospital admission costs were significantly lower in the intervention group -euro 4724 ( 95 % CI -7704 , -1734 ) . CONCLUSION This study in muscle-wasted COPD patients with moderate airflow obstruction shows a prolonged positive response to nutritional support integrated in a community-based rehabilitation program |
1,323 | 28,902,932 | Significant improvement was found in the scores assessing sleep quality among studies testing interventions such as earplugs , sleeping masks , muscle relaxation , posture and relaxation training , white noise , and educational strategies .
Conclusion : significant improvement was found among the scores assessing sleep in the studies testing interventions such as earplugs , sleeping masks , muscle relaxation , posture and relaxation training , white noise and music , and educational strategies | ABSTRACT Objective : to analyze evidence available in the literature concerning non-pharmacological interventions that are effective to treat altered sleep patterns among patients who underwent cardiac surgery . | Introduction Environmental stimulus , especially noise and light , is thought to disrupt sleep in patients in the intensive care unit ( ICU ) . This study aim ed to determine the physiological and psychological effects of ICU noise and light , and of earplugs and eye masks , used in these conditions in healthy subjects . Methods Fourteen subjects underwent polysomnography under four conditions : adaptation , baseline , exposure to recorded ICU noise and light ( NL ) , and NL plus use of earplugs and eye masks ( NLEE ) . Urine was analyzed for melatonin and cortisol levels . Subjects rated their perceived sleep quality , anxiety levels and perception of environmental stimuli . Results Subjects had poorer perceived sleep quality , more light sleep , longer rapid eye movement ( REM ) latency , less REM sleep when exposed to simulated ICU noise and light ( P < 0.05 ) . Nocturnal melatonin ( P = 0.007 ) and cortisol secretion levels ( P = 0.004 ) differed significantly by condition but anxiety levels did not ( P = 0.06 ) . Use of earplugs and eye masks result ed in more REM time , shorter REM latency , less arousal ( P < 0.05 ) and elevated melatonin levels ( P = 0.002 ) . Conclusions Earplugs and eye masks promote sleep and hormone balance in healthy subjects exposed to simulated ICU noise and light , making their promotion in ICU patients reasonable BACKGROUND Post-anaesthesia care units ( PACUs ) with 24/7 activity and consequently artificial light and noise may disturb the sleep of patients who require prolonged medical supervision . After one postoperative night , we compared sleep quality in patients with and without noise ( earplug ) and light ( eye mask ) protection . METHODS After ethical board approval , 46 patients without any neurological or respiratory failure undergoing major non-cardiac surgery were prospect ively included . They were r and omized to sleep with or without protective devices during the first postoperative night in the PACU . Sleep quality was simultaneously measured by sleep- quality scales ( Spiegel score and Medical Outcomes Study Sleep ) , nurses ' assessment , and through a wrist actigraph ( Actiwatch ) . Secondary outcomes such as pain control and nocturnal activity were recorded . Comparisons between groups were made by Student 's t-test or non-parametric test for repeated measures as appropriate ( SPSS 10.0 ) . A P-value < 0.05 was considered significant . RESULTS Data from 41 patients were analysed . Protective devices during the first postoperative night prevented a decrease in sleep quality compared with st and ard care , as evaluated by the Spiegel scale : 20 ( 4 ) vs 15 ( 5 ) , P=0.006 . These devices significantly decreased the need for a nap [ 50 % 95 % confidence interval ( CI ) ( 20 - 80 ) vs 95 % 95 % CI ( 85 - 100 ) , P<0.001 ] , but had no effect on sleep length evaluated by Actiwatch . The total consumption of morphine was significantly reduced in the first 24 h [ respectively , 15(12 ) mg and 27(17 ) mg , P=0.02 ] . CONCLUSIONS Earplugs and eye masks applied in the PACU during the first postoperative night significantly preserve sleep quality . Such non-invasive and cheap devices may be generalized in the PACU or in intensive care units Abstract Background : Poor sleep quality ( SQ ) is common among patients after coronary artery bypass graft surgery ( CABG ) . This study attempted to determine the status of SQ following an intervention based on the PRECEDE-PROCEED model in patients with poor SQ after CABG . Methods : This study was a r and omized clinical trial . The study sample , including 100 patients referred to the Cardiac Rehabilitation Clinic of Tehran Heart Center , was assigned either to the intervention ( recipient of exercise and lifestyle training plus design ed intervention based on the PRECEDE-PROCEED model ) or to the control group ( recipient of exercise and lifestyle training ) . Eight training sessions over 8 weeks were conducted for the intervention group . Predisposing , enabling , and reinforcing factors as well as social support and SQ were measured in the intervention group before and one month after the intervention and compared to those in the control group at the same time points . Results : The mean age of the patients in the intervention ( 24 % women ) and control ( 24 % women ) groups was 59.3 ± 7.3 and 59.5 ± 9.3 years , respectively . The results showed that the mean scores of SQ ( p value < 0.001 ) , knowledge ( p value < 0.001 ) , beliefs ( p value < 0.001 ) , sleep self-efficacy ( p value < 0.001 ) , enabling factors ( p value < 0.001 ) , reinforcing factors ( p value < 0.001 ) , and social support ( p value < 0.001 ) were significantly different between the intervention and control groups after the intervention . Conclusion : Adding an intervention based on the PRECEDE-PROCEED model to the cardiac rehabilitation program may further improve the SQ of patients INTRODUCTION : Poor sleep quality is common among patients following cardiopulmonary artery bypass graft surgery . Pain , stress , anxiety and poor sleep quality may be improved by massage therapy . OBJECTIVE : This study evaluated whether massage therapy is an effective technique for improving sleep quality in patients following cardiopulmonary artery bypass graft surgery . METHOD : Participants included cardiopulmonary artery bypass graft surgery patients who were r and omized into a control group and a massage therapy group following discharge from the intensive care unit ( Day 0 ) , during the postoperative period . The control group and the massage therapy group comprised participants who were subjected to three nights without massage and three nights with massage therapy , respectively . The patients were evaluated on the following mornings ( i.e. , Day 1 to Day 3 ) using a visual analogue scale for pain in the chest , back and shoulders , in addition to fatigue and sleep . Participants kept a sleep diary during the study period . RESULTS : Fifty-seven cardiopulmonary artery bypass graft surgery patients were enrolled in the study during the preoperative period , 17 of whom were excluded due to postoperative complications . The remaining 40 participants ( male : 67.5 % , age : 61.9 years ± 8.9 years , body mass index : 27.2 kg/m2 ± 3.7 kg/m2 ) were r and omized into control ( n = 20 ) and massage therapy ( n = 20 ) groups . Pain in the chest , shoulders , and back decreased significantly in both groups from Day 1 to Day 3 . The participants in the massage therapy group had fewer complaints of fatigue on Day 1 ( p = 0.006 ) and Day 2 ( p = 0.028 ) in addition , they reported a more effective sleep during all three days ( p = 0.019 ) when compared with the participants in the control group . CONCLUSION : Massage therapy is an effective technique for improving patient recovery from cardiopulmonary artery bypass graft surgery because it reduces fatigue and improves sleep Introduction Intensive care unit ( ICU ) environmental factors such as noise and light have been cited as important causes of sleep deprivation in critically ill patients . Previous studies indicated that using earplugs and eye masks can improve REM sleep in healthy subjects in simulated ICU environment , and improve sleep quality in ICU patients . This study aim ed to determine the effects of using earplugs and eye masks with relaxing background music on sleep , melatonin and cortisol levels in ICU patients . Methods Fifty patients who underwent a scheduled cardiac surgery and were expected to stay at least 2 nights in Cardiac Surgical ICU ( CSICU ) were included . They were r and omized to sleep with or without earplugs and eye masks combined with 30-minute relaxing music during the postoperative nights in CSICU . Urine was analyzed for nocturnal melatonin and cortisol levels . Subjective sleep quality was evaluated using the Chinese version of Richards-Campbell Sleep Question naire ( a visual analog scale , ranging 0–100 ) . Results Data from 45 patients ( 20 in intervention group , 25 in control group ) were analyzed . Significant differences were found between groups in depth of sleep , falling asleep , awakenings , falling asleep again after awakening and overall sleep quality ( P < 0.05 ) . Perceived sleep quality was better in the intervention group . No group differences were found in urinary melatonin levels and cortisol levels for the night before surgery , and the first and second nights post-surgery ( P > 0.05 ) . The urinary melatonin levels of the first and second postoperative nights were significantly lower than those of the night before surgery ( P = 0.01 ) . The opposite pattern was seen with urinary cortisol levels ( P = 0.00 ) . Conclusion This combination of non-pharmacological interventions is useful for promoting sleep in ICU adult patients ; however , any influence on nocturnal melatonin levels and cortisol level may have been masked by several factors such as the timing of surgery , medication use and individual differences . Larger scale studies would be needed to examine the potential influences of these factors on biological markers and intervention efficacy on sleep . Trial registration Chinese Clinical Trial Registry : ChiCTR-IOR-14005511 . Registered 21 November 2014 Background : Coronary artery bypass grafting ( CABG ) in high-risk patients is associated with significant perioperative complications and anxiety . Prevention of these postoperative complications and anxiety is important in the improvement of clinical outcomes following CABG . Objective : The objective of the study was to evaluate the effect of nurse-initiated preoperative education and counseling on postoperative complications and anxiety symptoms following CABG . Methods : In this prospect i ve and r and omized trial , 40 patients were divided into the study and control groups . All patients received st and ard preoperative and postoperative care , but the study group patients also completed a structured education and counseling course supervised by design ated nurses 3 days before the surgery . Anxiety symptoms were assessed by Zung ’s self-rating anxiety scale ( SAS ) on the day of admission and at 3 days after the surgery . Results : There was no statistically significant difference in the baseline characteristics or operational data between the 2 groups ( P > .05 ) . Following the surgery , the rate of complications such as lower extremity edema , urinary retention , constipation , respiratory infection , and deep venous thrombosis in the study group was lower than in the control group ( P < .05 ) . The mean postoperative SAS scores in the study group was lower than in the control group ( 40.1 [ SD , 6.5 ] vs 48.9 [ SD , 7.3 ] ; P = .01 ) , and the proportion of patients with a SAS score greater than 40 in the study group was also lower than in the control group ( 15 % vs 45 % , P = .041 ) . Conclusions : Nurse-initiated preoperational education and counseling were associated with a reduced rate of perioperative complications and a reduced level of anxiety following CABG AIMS AND OBJECTIVES To evaluate the effectiveness of an individualised programme to promote self-care in sleep-activity in patients with coronary artery disease . BACKGROUND Recent scientific findings have shown that low physical exercise and stress interfere with coronary artery disease patients ' sleep quality and sleep efficiency independent of gender , age and co-morbidity . DESIGN A r and omised pretest-post-test control design . METHODS Forty-seven patients who had undergone a coronary revascularisation procedure and /or pharmacological treatment three to seven weeks earlier at a general hospital were r and omised to either an intervention group or a control group . Data collection was carried out by question naires , a study -specific sleep diary and actigraphy registration for 10 consecutive 24-hour periods , with a follow-up after three to four months . The intervention group underwent a nurse-led individualised education programme to promote self-care of sleep-activity . Sleep habits and sleep-related lifestyle together formed the basis for setting up individual goals together with the nurse . Individual advice on physical training , relaxation exercise and a CD-based relaxation programme was provided by a physiotherapist . Both groups received a brochure about sleep and stress . RESULTS At a three- to four-month follow-up , the main improvements were seen in the intervention group regarding sleep quality , sleep duration and sleep efficiency in the sleep diary and sleep efficiency in actigraphy . Statistical improvements in health-related quality of life were revealed . This was not so obvious in the control group . CONCLUSIONS An individualised intervention programme to promote self-care of sleep-activity including relaxation in patients with coronary artery disease led by a nurse may improve sleep quality . However , a longitudinal study to promote self-care in sleep-activity should be performed using a larger sample and multiple sites with continuous follow-ups to determine whether any positive effects remain stable over time . RELEVANCE TO CLINICAL PRACTICE Implementation of a multiprofessional individualised programme to promote self-care of sleep-activity including relaxation based on patients ' needs , supported by a healthcare team and led by nurses , is important in clinical practice Disturbed sleep and sleep deprivation is common in patients in critical care setting s. Noise and inappropriate use of light/dark cycles are two of the causes of sleep interruptions . The purpose of the study was to evaluate eye masks and earplugs to help control patients ' exposure to noise and light within the critical care environment . An intervention study using a two group post-test quasi-experimental design of high dependency patients within a cardiothoracic critical care unit was undertaken by a group of critical care nurses . Sleep assessment rating scales and open-ended questions were used to obtain patients ' reported experiences of their sleep . Patients self-selected into either an intervention or non-intervention group . Sixty-four patients consented to take part in the study , 34 patients tried the interventions earplugs and eye masks and many found they improved sleep . However , noise was still a factor preventing sleep for both groups of patients . Mixed reports were found with the interventions from very comfortable to very uncomfortable . At a cost of 2.50 pounds sterling/patient , earplugs and eye masks were a relatively cheap intervention with notable improvements for some critically ill patients . Further research is required with a larger sample size , plus an examination of both earplugs and eye masks separately . Offering patient 's earplugs and eye masks to improve sleep should be considered as a matter of routine nursing practice , this should include time to show patients how to use and try them out for comfort BACKGROUND Critically ill patients are deprived of sleep and its potential healing qualities , although many receive medications to promote sleep . No one has adequately evaluated holistic nonpharmacological techniques design ed to promote sleep in critical care practice . OBJECTIVES To determine the effects of ( 1 ) a back massage and ( 2 ) combined muscle relaxation , mental imagery , and a music audiotape on the sleep of older men with a cardiovascular illness who were hospitalized in a critical care unit . METHODS Sixty-nine subjects were r and omly assigned to a 6-minute back massage ( n=24 ) ; a teaching session on relaxation and a 7.5-minute audiotape at bedtime consisting of muscle relaxation , mental imagery , and relaxing background music ( n=28 ) ; or the usual nursing care ( controls , n=17 ) . Polysomnography was used to measure 1 night of sleep for each patients . Sleep efficiency index was the primary variable of interest . One-way analysis of variance was used to test for difference in the index among the 3 groups . RESULTS Descriptive statistics showed improved quality of sleep among the back-massage group . Initial analysis showed a significant difference among the 3 groups in sleep efficiency index . Post hoc testing with the Duncan procedure indicated a significant difference between the back-massage group and the control group ; patients in the back-massage group slept more than 1 hour long than patients in the control group . However , the variance was significantly different among the 3 groups , and re analysis of data with only 17 subjects in each group revealed no difference among groups ( P=.06 ) . CONCLUSIONS Back massage is useful for promoting sleep in critically ill older men OBJECTIVE To investigate the influence of ocean sounds ( white noise ) on the night sleep pattern of postoperative coronary artery bypass graft ( CABG ) patients after transfer from an intensive care unit . DESIGN A before and after trial with an experimental and a control group was used in this intervention study . SETTING A large public hospital with primary , secondary , and tertiary care facilities . PATIENTS A consecutive sample of 60 first-time CABG patients was systematic ally assigned to the experimental or the control group . INTERVENTION For the experimental group , the sounds were played on the Marsona Sound Conditioner ( Marpac Corporation , Wilmington , NC ) for three consecutive nights posttransfer from the ICU . No control of environment , except for the elimination of white noise , was done for the control group . MAIN OUTCOME MEASURES The Richards-Campbell Sleep Question naire , a visual analog scale , provided self-reported sleep scores on six variables . Analysis of covariance was used to test the difference between the posttest scores of the groups , with the pretest used as the covariate . RESULTS There were significant differences in sleep depth , awakening , return to sleep , quality of sleep , and total sleep scores ; the group receiving ocean sounds reported higher scores , indicating better sleep . There was no difference in the falling asleep scores . CONCLUSION The use of ocean sounds is a viable intervention to foster optimal sleep patterns in postoperative CABG patients after transfer from the ICU The purpose of this experimental study was to determine the effects of second and third day postoperative music interventions ( music , music video ) on pain and sleep in 96 postoperative patients having CABG surgery . The Verbal Rating Scale scores obtained before and after each 30-minute session showed that pain decreased over time for all three groups with no difference across groups . The McGill Pain Question naire ( MPQ ) was administered before session 1 and after session 2 , and results indicated that Sensory , Affective , and Present Pain Intensity subscales showed no group difference for pain ; however , pain decreased from Day 2 to Day 3 for all three groups . For the evaluative component of pain , those in the music group had significantly ( F [ 2,93 ] = 4.74 , p < .05 ) lower scores on postoperative Day 2 than the rest period control group . Effects of the intervention on sleep as measured by the Richard Sleep Question naire indicated that the video group had significantly ( F [ 2 , 92 ] = 3.18 , p < .05 ) better sleep scores than the control group on the third morning . These findings lend some support for selected music interventions The purpose of this secondary analysis was to profile or cluster 226 patients , who had participated in a r and omized controlled trial , on symptoms after coronary artery bypass surgery and to examine how these profiles could potentially be used by clinicians to identify groups at risk for impaired functioning during the first 6 months after surgery . Variables measured were symptom presence and burden and functioning . The model-based clustering method was used for cluster analysis of the symptom burden measure , and analyses of covariance were used to determine if there were differences on functioning ( physical functioning and physical activity ) by symptom burden group at 6 weeks and at 3 and 6 months after dismissal . The majority of the 226 subjects were married ( 86 % ) , male ( 83 % ) , and had a mean age of 71 ( SD , 4.96 ) years . Eight symptoms were used in the model-based clustering method -shortness of breath , fatigue , depression , sleep disturbances , pain , swelling , anxiety , and appetite problems- and demonstrated that there were 3 patient clusters of symptom burden . Cluster 1 had low symptom burden on all 8 symptoms , cluster 3 had moderate symptom burden on all 8 symptoms , and cluster 2 had a combination of low ( shortness of breath , fatigue , depression , pain , and anxiety ) and moderate symptom burden ( sleep problems , swelling , and appetite problems ) . Analyses of covariance revealed no significant cluster × time interactions for any of the variables . However , there were significant main effects ( P < .01 ) for symptom burden groups for physical functioning ( physical and vitality functioning ) and physical activity ( estimated energy expenditure and mean daily total activity counts ) . Significant main effects for time indicated physical functioning and physical activity measures , except bodily pain , improved over time ( P < .05 ) . Study results indicate that the use of profiling coronary artery bypass surgery patients on their symptoms prior to hospital discharge may assist health care providers to identify patients who could be at risk for having more difficulty with physical functioning and physical activity during the first 6 months after surgery AIM The aim of this paper is to report an investigation of the effects of soft music on sleep quality in older community-dwelling men and women in Taiwan . BACKGROUND Sleep is a complex rhythmic state that may be affected by the ageing process . Few studies have focused on the effects of music , a non-pharmacological method of improving the quality of sleep in older adults . METHOD A r and omized controlled trial was used with a two-group repeated measures design . Sixty people aged 60 - 83 years with difficulty in sleeping were recruited through community leaders and screened using the Pittsburgh Sleep Quality Index ( PSQI ) and Epworth Sleepiness Scale . Those reporting depression , cognitive impairment , medical or environmental problems that might interfere with sleep ; and those who used sleeping medications , meditation , or caffeine at bedtime were excluded . Participants listened to their choice among six 45-minute sedative music tapes at bedtime for 3 weeks . There were five types of Western and one of Chinese music . Sleep quality was measured with the PSQI before the study and at three weekly post-tests . Groups were comparable on demographic variables , anxiety , depressive symptoms , physical activity , bedtime routine , herbal tea use , napping , pain , and pretest overall sleep quality . RESULTS Music result ed in significantly better sleep quality in the experimental group , as well as significantly better components of sleep quality : better perceived sleep quality , longer sleep duration , greater sleep efficiency , shorter sleep latency , less sleep disturbance and less daytime dysfunction ( P = 0.04 - 0.001 ) . Sleep improved weekly , indicating a cumulative dose effect . CONCLUSION The findings provide evidence for the use of soothing music as an empirically-based intervention for sleep in older people BACKGROUND AND PURPOSE There is disagreement in the literature about the importance of sleep disruption from intensive care unit ( ICU ) environmental noise . Previous reports have assumed that sleep disruption is produced by high-peak noise . This study aim ed to determine whether peak noise or the change in noise level from baseline is more important in inducing sleep disruption . We hypothesized that white noise added to the environment would reduce arousals by reducing the magnitude of changing noise levels . PATIENTS AND METHODS Four subjects underwent polysomnography under three conditions : ( 1 ) baseline , ( 2 ) exposure to recorded ICU noise and ( 3 ) exposure to ICU noise and mixed-frequency white noise , while one additional subject completed the first two conditions . Baseline and peak noise levels were recorded for each arousal from sleep . RESULTS A total of 1178 arousals were recorded during these studies . Compared to the baseline night ( 13.3+/-1.8 arousals/h ) the arousal index increased during the noise ( 48.4+/-7.6 ) but not the white noise/ICU noise night ( 15.7+/-4.5 ) ( P<0.004 ) . The change in sound from baseline to peak , rather than the peak sound level , determined whether an arousal occurred and was the same for the ICU noise and white noise/ICU noise condition ( 17.7+/-0.4 versus 17.5+/-0.3 DB , P=0.65 ) . CONCLUSIONS Peak noise was not the main determinant of sleep disruption from ICU noise . Mixed frequency white noise increases arousal thresholds in normal individuals exposed to recorded ICU noise by reducing the difference between background noise and peak noise BACKGROUND Patients awaiting cardiac surgery typically experience significant physical and psychological stress . However , although there is evidence that preoperative education interventions can lead to positive postoperative outcomes for surgical patients in general , less is known about the effectiveness among patients undergoing cardiac surgery , especially Chinese cardiac patients . OBJECTIVES To determine whether a preoperative education intervention design ed for Chinese cardiac patients can reduce anxiety and improve recovery . DESIGN R and omized controlled trial . SETTING S Cardiac surgical wards of two public hospitals in Luoyang , China . METHODS 153 adult patients undergoing cardiac surgery were r and omized into the trial , 77 to a usual care control group and 76 to preoperative education group comprising usual care plus an information leaflet and verbal advice . Measurement was conducted before r and omization and at seven days following surgery . The primary outcome was change in anxiety measured by the Hospital Anxiety and Depression Scale ( HADS ) . Secondary outcomes were change in depression ( HADS ) , change in pain as measured by subscales of the Brief Pain Inventory-short form ( BPI-sf ) , length of Intensive Care Unit stay and postoperative hospital stay . RESULTS Of 153 participants r and omized , 135 ( 88.2 % ) completed the trial . Participants who received preoperative education experienced a greater decrease in anxiety score ( mean difference -3.6 points , 95 % confidence interval -4.62 to -2.57 ; P<0.001 ) and a greater decrease in depression score ( mean difference -2.1 points , 95 % CI -3.19 to -0.92 ; P<0.001 ) compared with those who did not . There was no difference between groups in average pain , current pain , and interference in general activity , mood and walking ability . Patients r and omized to the preoperative education group reported less interference from pain in sleeping ( mean difference -0.9 points , 95 % CI -1.63 to -0.16 ; P=0.02 ) . There was some evidence to suggest a reduced number of hours spent in the Intensive Care Unit among preoperative education patients ( P=0.05 ) but no difference in length of postoperative hospital stay ( P=0.17 ) . CONCLUSIONS This form of preoperative education is effective in reducing anxiety and depression among Chinese cardiac surgery patients . Based upon existing evidence and international practice , preoperative education should be incorporated into routine practice to prepare Chinese cardiac patients for surgery |
1,324 | 17,636,688 | High intensity behavioural interventions that begin during a hospital stay and include at least one month of supportive contact after discharge promote smoking cessation among hospitalised patients .
These interventions are effective regardless of the patient 's admitting diagnosis .
lnterventions of lower intensity or shorter duration have not been shown to be effective in this setting .
There is insufficient direct evidence to conclude that adding NRT or bupropion to intensive counselling increases cessation rates over what is achieved by counselling alone , but the evidence of benefit for NRT has strengthened in this up date and the point estimates are compatible with research in other setting s showing that NRT and bupropion are effective | BACKGROUND An admission to hospital provides an opportunity to help people stop smoking .
Individuals may be more open to help at a time of perceived vulnerability , and may find it easier to quit in an environment where smoking is restricted or prohibited .
Initiating smoking cessation services during hospitalisation may help more people to make and sustain a quit attempt .
OBJECTIVES To determine the effectiveness of interventions for smoking cessation that are initiated for hospitalised patients . | INTRODUCTION Our goal was to investigate whether ambulatory smoking cessation among patients in a cardiologic department would ( 1 ) reduce the number of smokers by at least 25 % after 12 months compared to a control group and ( 2 ) influence whether the individual patient was readmitted to hospital . We used a r and omised , controlled , prospect i ve intervention project design . MATERIAL S AND METHODS Everyone hospitalised during the project period was screened . Those who fulfilled the criteria for inclusion were r and omised for inclusion in either the intervention group or the control group . Both groups were given the department 's smoking cessation information . In addition , the intervention group attended five ambulatory smoking cessation intervention sessions . Each patient 's smoking status was registered after 12 months . chi2-test and logistic regression analysis were used to test differences , associations and control of confounders . RESULTS In all , 3,982 patients were screened , 29.5 % of whom were smokers . The study included 105 patients : 54 in the intervention group and 51 in the control group . After 12 months , 52 % of those in the intervention group compared to 39 % in the control group had become non-smokers , which was non-significant ( p = 0,14 ) . Ischemic heart disease ( IHS ) was significantly associated with smoking cessation . After adjustment for this confounder , the result was enhanced ( p = 0,06 ) . Readmission to hospital was not affected by smoking cessation ( p = 0,73 ) . DISCUSSION Ambulatory smoking cessation intervention had no significant effect on smoking cessation on an unselected group of patients in a cardiologic hospital department . The project does indicate that ambulatory smoking cessation interventions could have an effect on patients with IHS BACKGROUND This study examined the 1-year effects of a minimal-contact smoking cessation intervention for cardiac in patients . METHODS The multicenter study included cardiac in patients who had smoked prior to hospitalization . A pretest-posttest quasi-experimental design was used . Patients ' experimental condition depended on the hospital they were assigned to . The design was partially r and omized : 4 of the 11 hospitals selected the experimental condition themselves ( 2 experimental , 2 control ) , while the remaining 7 hospitals were r and omly assigned . The experimental group consisted of patients of 5 hospitals ( N = 388 ) . Patients of 6 other hospitals served as the control group ( N = 401 ) . The intervention included stop-smoking advice by the cardiologist , brief counseling by the nurse , the provision of self-help material s , and aftercare by the cardiologist . RESULTS Logistic regression analyses controlling for baseline differences and covariates did not show significant intervention effects on point prevalence and continuous abstinence . The study also showed that the outcomes were not significantly related to the way hospitals were assigned to the experimental condition . CONCLUSIONS While short-term effects were found , the minimal-contact intervention did not result in significant effects after 12 months , at least if patients lost to follow-up were treated as posttest smokers . Efforts should be made to improve the intervention , especially the aftercare BACKGROUND Although smoking cessation is essential for prevention of secondary cardiovascular disease ( CVD ) , many smokers do not stop smoking after hospitalization . Mild depressive symptoms are common during hospitalization for CVD . We hypothesized that depressive symptoms measured during hospitalization for acute CVD would predict return to smoking after discharge from the hospital . METHODS This was a planned secondary analysis of data from a placebo-controlled , double-blind , r and omized trial of bupropion hydrochloride therapy in 245 smokers hospitalized for acute CVD . All subjects received smoking counseling in the hospital and for 12 weeks after discharge . Depressive symptoms were measured during hospitalization with the Beck Depression Inventory ( BDI ) , and smoking cessation was biochemically vali date d at 2-week , 12-week , and 1-year follow-up . The effect of depressive symptoms on smoking cessation was assessed using multiple logistic regression and survival analyses . RESULTS Twenty-two percent of smokers had moderate to severe depressive symptoms ( BDI > or= 16 ) during hospitalization . These smokers were more likely to resume smoking by 4 weeks after discharge ( P= .007 ; incidence rate ratio , 2.40 ; 95 % confidence interval , 1.48 - 3.78 ) than were smokers with lower BDI scores . Smokers with low BDI scores were more likely to remain abstinent than were those with high BDI scores at 3-month follow-up ( 37 % vs 15 % ; adjusted odds ratio , 3.02 ; 95 % confidence interval , 1.28 - 7.09 ) and 1-year follow-up ( 27 % vs 10 % ; adjusted odds ratio , 3.77 ; 95 % confidence interval , 1.31 - 10.82 ) . We estimate that 27 % of the effect of the BDI score on smoking cessation was mediated by nicotine withdrawal symptoms . CONCLUSIONS Moderate to severe depressive symptoms during hospitalization for acute CVD are independently associated with rapid relapse to smoking after discharge and lower rates of smoking cessation at long-term follow-up . The relationship was mediated in part by the stronger nicotine withdrawal symptoms experienced by smokers with higher depressive symptoms Background : Guidelines recommend that smoking cessation interventions are offered in all clinical setting s to all smokers willing to make a quit attempt . Since the effectiveness of routine provision of behavioural counselling and nicotine replacement therapy ( NRT ) to smokers admitted to hospital has not been established , a r and omised controlled trial of these interventions given together compared with counselling alone or minimal intervention was performed in hospital in patients . Methods : Medical and surgical in patients who were current smokers at the time of admission were r and omised to receive either usual care ( no additional advice at admission ) , counselling alone ( 20 minute intervention with written material s ) , or NRT plus counselling ( counselling intervention with a 6 week course of NRT ) . Continuous and point prevalence abstinence from smoking ( vali date d by exhaled carbon monoxide < 10 ppm ) was measured at discharge from hospital and at 3 and 12 months , and self-reported reduction in cigarette consumption in smokers was assessed at 3 and 12 months . Results : 274 inpatient smokers were enrolled . Abstinence was higher in the NRT plus counselling group ( n=91 ) than in the counselling alone ( n=91 ) or usual care ( n=92 ) groups . The difference between the groups was significant for vali date d point prevalence abstinence at discharge ( 55 % , 43 % , 37 % respectively , p=0.045 ) and at 12 months ( 17 % , 6 % , 8 % , p=0.03 ) . The respective differences in continuous vali date d abstinence at 12 months were 11 % , 4 % , 8 % ( p=0.25 ) . There was no significant difference between counselling alone and usual care , or in reduction in cigarette consumption between the treatment groups . Conclusions : NRT given with brief counselling to hospital in patients is an effective routine smoking cessation intervention Recent findings suggest that smokers who are hospitalized experience significant craving for cigarettes . Thus , nicotine replacement therapy ( NRT ) may be a particularly important tool for use during hospitalization . The goal of this study is to evaluate the utilization of the transdermal nicotine patch and /or nicotine gum by hospitalized smokers . The data represented in this article are from 580 smokers who participated in a study of a motivational intervention for smoking cessation that was delivered during hospitalization . The primary outcome for this analysis was use of NRT during hospitalization . The results revealed that , among the entire sample , only 7.1 % of the overall sample used NRT during hospitalization ; 6 % of the hospitalized smokers used the transdermal nicotine patch , and 1.1 % used nicotine gum . Use of NRT was significantly greater among patients who reported that they were doing anything to help themselves quit smoking at the time of admission ( OR=4.1 ) , those who were seriously planning to quit smoking within the next 30 days ( OR=2.36 ) , those who were nicotine dependent ( OR=2.81 ) , and those for whom a physician had ever offered to prescribe NRT (OR=1.9).The finding that there is a very low rate of NRT use during hospitalization provides important information to hospital-based care providers and smoking cessation intervention planners . Barriers to NRT use among hospitalized patients should be identified , and strategies design ed to maximize use when appropriate . TheAHCPR Guideline on Smoking Cessation recommends routine use of NRT in health care setting s. Further research is needed to determine why NRT use was so low . In addition , these data suggest that efforts to increase NRT use during hospitalization are needed Cigarette smoking is a major risk factor for head and neck cancer , and individuals who continue to smoke past diagnosis and treatment are at elevated risk for further disease . In a r and omized controlled trial , a state of the art provider-delivered smoking cessation intervention was compared to a usual care advice control condition . The intervention consisted of surgeon- or dentist-delivered advice to stop smoking , a contracted quit date , tailored written material s , and booster advice sessions . Subjects were 186 patients with newly diagnosed first primary squamous cell carcinomas of the upper aerodigestive tract who had smoked cigarettes within the past year . At r and omization , 88.2 % of subjects were current smokers . At 12-month follow-up , 70.2 % of subjects completing the trial ( n = 114 ) were continuous abstainers ; among baseline smokers alone the continuous abstinence ( CA ) rate was 64.6 % . The cotinine validation rate at 12 months was 89.6 % . Modeling techniques were utilized in order to derive expected CA rates , which included noncompleter subjects ( n = 72 ) . The CA rate expected at 1 year for the entire patient population was 64.2 % , and for smokers alone the expected CA rate was 59.4 % . Logistic regression analysis carried out on baseline smokers identified predictors of 12-month CA status . These included medical treatment , stage of change , age , nicotine dependence , and race . The intervention effect was not significant , although the sign of the effect was positive . Based on these findings , we recommend systematic brief advice to stop smoking for head and neck cancer patients , with a stepped care approach for patients less able to quit A controlled evaluation of a minimal-contact smoking cessation intervention was conducted with 213 in patients and out patients at a Veterans Administration Medical Center ( VAMC ) . The intervention had three components : Brief consultation from a health practitioner ; administration of a self-help smoking cessation manual ; and provision of an incentive to adhere to recommendations in the manual . Enrollment procedures differed from those of many other smoking-intervention trials in that , instead of enrolling only smokers who were motivated to quit , all patients who smoked and who would normally be considered eligible for a smoking-cessation intervention were included . The evaluation examined acceptability of the program to patients who smoked , overall effectiveness of the intervention , and efficacy of the intervention for specific patient demographic , social status , and health status groups . The program had a high degree of acceptance by patients who smoked , with over 60 % agreeing to participate and take home the self-help smoking-cessation manual . The program was effective in getting patients to reduce their daily smoking , and marginally effective in influencing smoking cessation , with some patient groups exhibiting higher cessation rates than others . Special problems to be considered when attempting to influence groups of smokers at high levels of psychological stress and with low levels of education and income -- factors normally associated with high rates of smoking and failure in traditional smoking-cessation programs -- are discussed in light of the results obtained BACKGROUND Cessation rates in smokers attending special clinics or their General Practitioners can be increased by transdermal nicotine ( TNS ) . This study assesses the efficacy of TNS as an adjunct to advice and support in helping patients attending hospital with smoking-related diseases to stop smoking . METHODS In a double-blind , placebo-controlled , r and omized manner , 234 in patients and out patients with smoking-related respiratory or cardiovascular disease , aged 18 - 75 years , who were willing to try to stop smoking , were advised by their hospital doctor to stop smoking . This was reinforced by repeated advice and encouragement from the Smoking Cessation Counsellor initially and at 2 , 4 , 8 and 12 weeks , supplemented by a 24 h patch in adjusted doses over that period . Those not smoking at 12 weeks were followed up at 26 and 52 weeks . Self-reported complete abstinence from 12 to 52 weeks was vali date d by expired air carbon monoxide measurement at 12 , 26 and 52 weeks . RESULTS Twenty-four ( 21 % ) of 115 TNS patients were verified as non-smokers at 12 , 26 and 52 weeks and cl aim ed continued abstinence , compared with 17 ( 14 % ) of 119 in the placebo ( P ) group ( P = 0 center dot 15 ) -5 % confidence limits for odds ratio of abstinence on TNS compared to P : 0 center dot 83 , 3 center dot 37 . Cessation was related to increasing age ( P = 0 center dot 02 ) and lower Fagerstrom score ( P = 0 center dot 05 ) . Minor skin reactions were more frequent in the TNS group ( 47 % TNS ; 34 % P ) , as was nausea ( 12 % TNS ; 3 % P ) . Severe skin reactions were rare ( 5 % TNS ; 4 % P ) . CONCLUSION The suggestion that TNS produces an increase of 50 % in relative terms ( 7 % absolute increase ) in smoking cessation over placebo in this population of hospital patients is sufficiently strong to warrant a further study large enough to answer whether or not this result was due to chance Many patients attempt to stop smoking during hospitalization , but most relapse after discharge . This study developed and evaluated a brief smoking-cessation and relapse-prevention program for hospitalized smokers . All hospitalized smokers ( n=1,119 ) were identified by question naire at hospital admission and then received either usual care or usual care plus a hospital-based smoking- cessation intervention regardless of interest in stopping smoking . Intervention components included a 20-minute bedside counseling session , a 12-minute videotape , a variety of self-help material s , and a follow-up telephone call . Special attention was given to techniques for preventing relapse after hospital discharge . Defining ex-smokers as those who reported no tobacco use at both 3- and 12-month follow-up assessment s , and counting those lost to follow-up as smokers , the intervention increased the proportion of patients who quit smoking by one half ( 9.2%vs 13.5 % , P<0.05 ) . These results demonstrate the efficacy of a brief in-hospital intervention and suggest that relapse-prevention efforts are needed to convert temporary cessation during hospitalization into longterm abstinence Debate exists about how intense smoking cessation interventions for hospitalized patients should be . In this study we assessed the effectiveness of a low-intensity smoking cessation intervention for hospitalized patients , without follow-up phone calls . We design ed a cohort study with a historical control group , in the Department of Medicine of an 850-bed teaching hospital . One hundred and seventeen consecutive eligible smokers received the intervention , and 113 smokers hospitalized before the implementation of the intervention constituted the historical control group . The 30-min smoking cessation intervention was performed by a trained resident without any follow-up contact . Counseling was matched to smokers ' motivation to quit , and accompanied by a self-help booklet . Nicotine replacement therapy was prescribed when indicated . All patients received a question naire to evaluate their smoking habits 6 months after they left hospital . We counted patients lost to follow-up as continuous smokers and smoking abstinence was vali date d by patients ' physicians . Vali date d smoking cessation rates were 23.9 % in the intervention group and 9.7 % in the control group ( odds ratio 2.9 , 95 % confidence interval : 1.4–6.2 ) . After adjusting for potential confounders , intervention was still effective with an adjusted odds ratio of 2.26 ( 95 % confidence interval : 1.04–4.95 ) . Among those who continued to smoke 6 months after hospitalization , the likelihood of reporting any decrease of cigarette consumption was higher in the intervention cohort ( 70.8 vs. 42.7 % , P=0.001 ) . A low-intensity smoking cessation intervention , based on two visits without any follow-up contact , is associated with a higher quit rate at 6 months than that for historical control patients . Our findings show that a low-intensity smoking cessation intervention , based on two visits without any follow-up contact , is associated with a higher quit rate at 6 months than that for historical control patients OBJECTIVES This article describes the demographic , psychosocial , and medical characteristics and smoking patterns of women hospitalized with cardiovascular disease ( CVD ) enrolled in the Women 's Initiative for Nonsmoking ( WINS ) trial . DESIGN Study design is a r and omized clinical trial with cross-sectional baseline data . SETTING Women enrolled during a 27-month period from 10 hospitals in the San Francisco Bay Area . PARTICIPANTS Subjects included 277 women . RESULTS The women 's ages ranged from 33 to 86 years , with a mean age of 60.7 ( + /-10 ) years . Most ( 51 % ) were college graduates , had attended some college or had postgraduate degrees ; 40 % were married ; 76 % were white . Median income was between 30,000 dollars and 35,000 , but 27 % of the women had incomes less than 15,000 dollars per year . The women smoked a median of 20 cigarettes per day ( range , 1 - 90 ) . Median age when women began smoking was 18.6 years ; average number of years smoked was 40 ; and 78 % had made more than 2 previous attempts to quit . On a 10-point scale , 71 % of the women rated their confidence to quit smoking ( self-efficacy ) as 5 or greater . According to the Burnam Depression Screener , 56.7 % were depressed . CONCLUSIONS This is the largest study describing the smoking patterns of women hospitalized with CVD . These women were older , white , had smoked for many years , were moderately to highly addicted to tobacco , had few financial re sources , and a large proportion were depressed . These important psychosocial factors need to be taken into account when planning smoking cessation interventions for women with CVD Background : Many surgical patients are dependent on nicotine . Smoke-free policies in healthcare facilities m and ate abstinence from smoking , which could contribute to psychological stress in the perioperative period . The authors tested the hypothesis that nicotine replacement therapy decreases psychological stress in cigarette smokers scheduled to undergo elective surgery and determined whether nicotine replacement therapy affects postoperative smoking behavior , even when not specifically prescribed to promote abstinence . Methods : In this double-blind , placebo-controlled trial , 121 smokers , of whom 116 received a study intervention , were r and omly assigned to receive either active ( nicotine-containing ) or placebo patches , beginning on the morning of surgery and continuing for up to 30 days after discharge from the hospital . Outcomes included the Perceived Stress Score , the Nicotine Withdrawal Score , and subject self-report of smoking behavior . Results : The Perceived Stress Score and the Nicotine Withdrawal Score did not change significantly from baseline over the immediate perioperative period and did not differ between active or placebo patch groups ( all P > 0.19 ) . The percentage of placebo versus active patch subjects reporting 7-day abstinence at 30 days postoperatively ( 30 % vs. 39 % ; P = 0.29 ) did not differ significantly between groups . At 30 days postoperatively , subjects in both groups significantly reduced their cigarettes smoked per day from baseline , but those receiving active patches reported a greater decrease ( a mean decrease of 11 ± 11 vs. 15 ± 7 cigarettes/day in placebo and active groups ; P = 0.045 ) . Conclusion : Routine nicotine replacement therapy is not indicated in smokers undergoing surgery for the purpose s of managing nicotine withdrawal and stress but can modify some aspects of postoperative smoking behavior Women 's Initiative for Nonsmoking ( WINS ) is a r and omized clinical trial design ed to test the efficacy of a nurse-managed smoking cessation and relapse prevention intervention design ed specifically for women . The WINS intervention is rooted in social learning theory , specifically that of self-efficacy . It is a multimedia approach that provides education , counseling , and telephone follow-up that meet the smoking cessation intervention guidelines established by the Agency for Health Care Policy and Research . The WINS intervention has been successfully implemented in more than 140 women and has proven to be feasible and well accepted by both the women and their health care providers . Although the intervention in the protocol -driven r and omized clinical trial was begun in the hospital , it is anticipated that nurses in any setting , inpatient or outpatient , who serve population s at risk for cardiovascular disease , peripheral vascular disease , lung cancer , or pulmonary disease could successfully provide the intervention Background : Smoking is a major public health issue , estimated as causing 120 000 deaths in the UK per year . Smoking cessation is an important aspect of the treatment of many diseases . Nicotine replacement therapy ( NRT ) has been shown to increase cessation rates among healthy volunteers and in general practice , but it is not clear whether it has an effect in hospital patients . Methods : Patients referred by their hospital doctor to the smoking cessation counsellor and who agreed to participate in the study were r and omised to receive either NRT given as a nicotine patch daily and a nicotine inhalator on an as needed basis plus advice and support ( AS+NRT ) , or to receive just advice and support ( AS ) . Cl aims of smoking cessation were vali date d at 1 week , 3 months , 6 months , and 1 year by carbon monoxide ( CO ) breath testing . Results : A total of 245 patients were r and omised , 136 AS+NRT and 109 AS . There were no significant demographic differences between the two groups at baseline . At 1 year 35 ( 14 % ) had sustained cessation confirmed by a CO breath test , 20/136 ( 15 % ) AS+NRT and 15/109 ( 14 % ) AS , p=0.857 . One hundred and ten patients gave up smoking for at least 1 week , 54 % AS+NRT and 33 % AS ( p<0.001 ) . By 6 months there was no significant difference between the two groups ( 22/136 ( 16 % ) AS+NRT and 15/109 ( 14 % ) AS ) . Conclusion : In hospital patients NRT , given as regular daily patches plus an inhalator to be used as needed , did not add to the smoking cessation rate achieved at 1 year by regular advice and support , despite significantly increasing the cessation rate at 1 week This article describes the design and methods of the Women 's Initiative for Nonsmoking , a nurse-managed intervention for smoking cessation and relapse prevention in women hospitalized with cardiovascular disease . The Women 's Initiative for Nonsmoking is a r and omized clinical trial with a 3-month intervention period and follow-up at 6 , 12 , 24 , and 30 months . Data were collected at 10 urban hospitals in the San Francisco Bay area . The sample consisted of 278 women , mean age 61 years , hospitalized with cardiovascular disease ( angina , myocardial infa rct ion , angioplasty , coronary artery bypass graft surgery , heart failure , valvular disease , peripheral vascular disease , and cerebrovascular disease ) . The behavioral intervention consisted of nurse-managed care focused on preventing relapse after smoking cessation during hospitalization . Measures included demographic , clinical ( includes diagnosis and comorbidity data ) , smoking history , confidence question naire , stress , depression , and quality of life . This article provides a detailed description of research design and methods for research ers desiring to replicate the study and nurse practitioners developing a smoking cessation , risk-reduction program in the clinical setting . Results of the trial are forthcoming This study reports on the effectiveness of a nurse case-managed smoking cessation program for general hospitalized patients that was continued for 3 years after clinical trials were completed . Patients admitted to the hospital who smoked were offered a smoking cessation program during their hospitalization . The program included physician advice , bedside education and counseling with a nurse specially trained in smoking cessation techniques , take-home material s ( videotape , workbook , and relaxation audiotape ) , nicotine replacement therapy if requested or indicated , and four nurse-initiated post-discharge telephone counseling calls . Of the 2091 patients identified as smokers , 52 % enrolled in the program , 18 % wanted to quit on their own , 20 % did not want to quit , and 10 % were ineligible . The 12-month self-reported cessation rate ( 7-day point prevalence ) was 35 % if patients lost to follow-up were considered smokers , 49 % if not . Patients hospitalized for cancer , cardiovascular , or pulmonary reasons were most likely to participate and had the highest self-reported cessation rates ( 63 % , 57 % , and 46 % , respectively ) . This nurse-managed smoking cessation intervention was effective when it was put into st and ard hospital practice outside of its originating r and omized clinical trial structure . The program , relatively inexpensive to deliver , appears to be acceptable to the majority of smokers who are hospitalized , result ed in high 1-year cessation rates , and can be extended to hospital employees and their families , work-sites , and communities on a cost-recovery basis Hospital patients with smoking-related diseases rarely heed medical advice to stop smoking even when this advice is reinforced with nicotine gum and written material ( 1,2 ) , the exception being those with acute myocardial infa rct ion ( 3,4 ) . In contrast , success rates with advice , nicotine gum and specialized support sessions in smoking cessation clinics range from 38 % in healthy clients ( 5 ) to 29 % in a mixed group of clients and patients ( 6 ) . In our study the ' stop smoking ' advice of the physician was reinforced by advice/support from a research assistant ( SB ) and by nicotine ( N ) or placebo ( P ) chewing gum OBJECTIVE To assess the level of nicotine replacement , evidence of nicotine toxicity , and withdrawal symptom relief with placebo and 11- , 22- , and 44-mg/d doses of transdermal nicotine . A secondary objective was to assess short- and long-term smoking cessation rates . DESIGN R and omized , double-blind , placebo-controlled inpatient/outpatient trial . SUBJECTS Seventy-one cigarette smokers stratified according to light ( n = 23 ) , moderate ( n = 24 ) , and heavy ( n = 24 ) smoking rates . INTERVENTIONS After baseline measures were obtained , subjects were r and omly assigned to placebo or an 11- , 22- , or 44-mg/d dose of transdermal nicotine and admitted to a special hospital unit for intensive inpatient treatment of nicotine dependence . During the 6-day inpatient stay , daily nicotine and cotinine levels were determined from trough and peak blood sample s. Outpatient patch therapy continued for 7 weeks following the hospital stay , and those initially assigned to placebo were r and omly assigned to 11 or 22 mg/d . At week 4 , the dosage of those initially assigned to 44 mg/d was reduced to 22 mg/d . MAIN OUTCOME MEASURES Percentage of replacement of cotinine was calculated by dividing the steady-state levels attained during patch therapy by the corresponding baseline levels . Abstinence from smoking was verified by expired air carbon monoxide . Withdrawal symptoms and nicotine toxicity were assessed daily through question naires during the inpatient stay . Follow-up visits were at 3 , 6 , 9 , and 12 months . RESULTS There was a statistically significant relationship between baseline smoking rate and baseline trough and peak blood cotinine levels ( rs = 0.39 , rs = 0.45 ; P < .001 in both instances ) . A dose-response relationship was observed with higher patch doses , which produced a higher percentage of cotinine replacement and better withdrawal symptom relief . Only one subject ( a light smoker assigned to the 44-mg dose ) developed signs of nicotine toxicity . There was a positive association between the week 2 patch dose and the biochemically confirmed abstinence at the end of patch therapy ( P = .007 ) but not for subsequent follow-up times . A higher percentage of cotinine replacement was associated with the higher 8-week smoking abstinence rate ( P = .03 ) , an association not found at long-term follow-up . CONCLUSION A 44-mg/d dose of nicotine patch therapy appears to be safe for use in heavy smokers . Cigarette smoking rates can be used to estimate the initial nicotine patch dose . Monitoring blood cotinine levels at baseline and steady state can be used for assessing the adequacy of nicotine replacement . Withdrawal symptom relief can be improved with more complete nicotine replacement . Achieving a greater percentage of nicotine replacement may increase the efficacy of nicotine patch therapy This study examined the effectiveness of smoking cessation counseling by physicians-in-training ( residents ) with African-American patients . One hundred fifty-eight family and internal medicine residents at a large urban public general hospital participated in the study ; two thirds of the residents underwent a 2-hour smoking cessation training program . Ninety-two of the trained physicians counseled from 1 to 18 patients . The majority of physicians were male , with 8 % being current smokers . Over a 26-month period , 1086 patients were r and omly assigned to intervention and control ( usual care ) groups . Mean patient age was 44 years , mean years smoking was 25 , and mean number of cigarettes smoked per day was 14 . There were no differences in biochemically vali date d smoking cessation rates between the intervention and control groups at 3 or 12 months postenrollment ( 2 % versus 1.8 % and 2.2 % versus 2.8 % , respectively ) . Losses to follow-up were high at both 3 and 12 months ( 38 % and 40 % respectively ) . Implication s for future trials in minority population s are discussed . A brief physician-based smoking cessation message does not appear to be an effective strategy for use with African-American smokers in a large urban public general hospital Background Smoking is an important risk factor for cardiovascular disease ( CVD ) , and quitting is highly beneficial . Yet , less than 30 % of CVD patients stop smoking . Relapse-prevention strategies seem most effective when initiated during the exacerbation of the disease . Objective A nurse-delivered inpatient smoking cessation program based on the Transtheoretical Model with telephone follow-up tailored to levels of readiness to quit smoking was evaluated on smoking abstinence and progress to ulterior stages of change . Method Participants ( N = 168 ) were r and omly assigned by cohorts to inpatient counseling with telephone follow-up , inpatient counseling , and usual care . The inpatient intervention consisted of a 1-hr counseling session , and the telephone follow-up included 6 calls during the first 2 months after discharge . The nursing intervention was tailored to the individual 's stage of change . End points at 2 and 6 months included actual and continuous smoking cessation rates ( biochemical markers ) and increased motivation ( progress to ulterior stages of change ) . Results Assuming that surviving patients lost to follow-up were smokers , the 6-month smoking abstinence rate was 41.5 % in the inpatient counseling with telephone follow-up group , compared with 30.2 % and 20 % in the inpatient counseling and usual care groups , respectively ( p = .05 ) . Progress to ulterior stages of change was 43.3 % , 32.1 % , and 18.2 % , respectively ( p = .02 ) . Stage of change at baseline and intervention predicted smoking status at 6 months . Discussion This tailored smoking cessation program with telephone follow-up significantly increased smoking cessation at 6 months , and progression to ulterior stages of change . The telephone follow-up was an important adjunct . It is , therefore , recommended to include such comprehensive smoking cessation programs within hospital setting s for individuals with CVD Abstract Objective : To evaluate a smoking cessation intervention that can be routinely delivered to smokers admitted with cardiac problems . Design : R and omised controlled trial of usual care compared with intervention delivered on hospital wards by cardiac rehabilitation nurses . Setting : Inpatient wards in 17 hospitals in Engl and . Participants : 540 smokers admitted to hospital after myocardial infa rct ion or for cardiac bypass surgery who expressed interest in stopping smoking . Intervention : Brief verbal advice and st and ard booklet ( usual care ) . Intervention lasting 20 - 30 minutes including carbon monoxide reading , special booklet , quiz , contact with other people giving up , declaration of commitment to give up , sticker in patient 's notes ( intervention group ) . Main outcome measures : Continuous abstinence at six weeks and 12 months determined by self report and by biochemical validation at these end points . Feasibility of the intervention and delivery of its components . Results : After six weeks 151 ( 59 % ) and 159 ( 60 % ) patients remained abstinent in the control and intervention group , respectively ( P=0.84 ) . After 12 months the figures were 102 ( 41 % ) and 94 ( 37 % ) ( P=0.40 ) . Recruitment was slow , and delivery of the intervention was inconsistent , raising concerns about the feasibility of the intervention within routine care . Patients who received the declaration of commitment component were almost twice as likely to remain abstinent than those who did not receive it ( P<0.01 ) . Low dependence on tobacco and high motivation to give up were the main independent predictors of positive outcome . Patients who had had bypass surgery were over twice as likely to return to smoking as patients who had had a myocardial infa rct ion . Conclusions : Single session interventions delivered within routine care may have insufficient power to influence highly dependent smokers . What is already known on this topic Stopping smoking after a serious cardiac event is associated with a significant decrease in mortality Up to 70 % of smokers who survive cardiac surgery smoke again within a year Intensive interventions delivered by dedicated staff can help cardiac patients not to start to smoke again What this study adds An intervention delivered by cardiac rehabilitation nurses within routine care during patients ' hospital stay failed to increase the number who managed to stop smoking in the long term For busy staff with competing priorities , the 30 minute intervention was also on the borderline of practicability Patients admitted after a myocardial infa rct ion were over twice as likely to give up than those admitted for a bypass BACKGROUND Smokers are at higher risk of cardiopulmonary and wound-related postoperative complications than non-smokers . Our aim was to investigate the effect of preoperative smoking intervention on the frequency of postoperative complications in patients undergoing hip and knee replacement . METHODS We did a r and omised trial in three hospitals in Denmark . 120 patients were r and omly assigned 6 - 8 weeks before scheduled surgery to either the control ( n=60 ) or smoking intervention ( 60 ) group . Smoking intervention was counselling and nicotine replacement therapy , and either smoking cessation or at least 50 % smoking reduction . An assessor , who was masked to the intervention , registered the occurrence of cardiopulmonary , renal , neurological , or surgical complications and duration of hospital admittance . The main analysis was by intention to treat . FINDINGS Eight controls and four patients from the intervention group were excluded from the final analysis because their operations were either postponed or cancelled . Thus , 52 and 56 patients , respectively , were analysed for outcome . The overall complication rate was 18 % in the smoking intervention group and 52 % in controls ( p=0.0003 ) . The most significant effects of intervention were seen for wound-related complications ( 5 % vs 31 % , p=0.001 ) , cardiovascular complications ( 0 % vs 10 % , p=0.08 ) , and secondary surgery ( 4 % vs 15 % , p=0.07 ) . The median length of stay was 11 days ( range 7 - 55 ) in the intervention group and 13 days ( 8 - 65 ) in the control group . INTERPRETATION An effective smoking intervention programme 6 - 8 weeks before surgery reduces postoperative morbidity , and we recommend , on the basis of our results , this programme be adopted We assessed the efficacy of a comprehensive programme for stopping smoking in 210 smokers scheduled for surgery , before admission and 3 months after attending a pre‐operative clinic . Participants were r and omly allocated to receive an intervention incorporating nicotine replacement therapy for patients smoking more than 10 cigarettes per day ( ‘ dependent smokers ’ ) , or to a control group to receive usual care . Dependent smokers allocated to the intervention group were more likely to report abstinence before surgery than those allocated to receive usual‐care ( 63 ( 73 % ) vs. 29 ( 56 % ) , respectively ; OR 2.2 ( 95 % CI 1.0–4.8 ) ) , and 3 months after attendance ( 16 ( 18 % ) vs. 3 ( 5 % ) , respectively ; OR = 3.9 ( 95 % CI 1.0–21.7 ) Smokers with smoking-related diseases who are hospitalized in rehabilitation centers should be offered smoking cessation . This is the first study evaluating whether telephone booster sessions after intensive inpatient treatment are an effective strategy . The present study was conducted in 13 rehabilitation centers for somatic disorders as a prospect i ve multicenter study with a r and omized treatment-control group design . We compared abstinence rates after hospital discharge from treatment that included a group smoking cessation program with ( treatment group ) and without telephone booster sessions ( control group ) . Data from 290 smokers were analyzed . After 6 and 12 months the treatment group achieved abstinence rates twice as high as those of the control group . Men profited more from telephone booster sessions than did women . Results indicated that telephone booster sessions were highly effective ( even ) after an inherently intensive group program during a hospital stay . Further research should focus on the special needs of women receiving telephone counseling OBJECTIVE To examine the effect of a nurse-delivered smoking cessation intervention on short-term smoking abstinence among hospitalized postoperative patients . DESIGN Prospect i ve , experimental , r and om assignment . SETTING Midwestern university-affiliated tertiary medical center . PATIENTS Postoperative smokers ( n = 80 ) from cardiovascular , oncology , and general surgical units . OUTCOME MEASURE Self-reported smoking status and saliva cotinine level at 5 to 6 weeks after hospitalization . INTERVENTION Three structured smoking cessation sessions during hospitalization , followed by phone calls once a week for 5 weeks after discharge . RESULTS Of the experimental group patients , 37.8 % were abstinent as compared to 25.6 % in the usual care group . Abstinence rates of experimental group patients from cardiovascular ( 40 % ) and oncology ( 64.3 % ) units were higher than that of GS ( 13.3 % ) unit patients . Regardless of group assignment , 100 % of cardiovascular and oncology patients abstained during hospitalization , compared to only 10.7 % of GS patients . CONCLUSIONS Preliminary results indicate that a nurse-delivered cessation intervention may be effective postoperatively among smokers with an identified smoking-related diagnosis Background Providing information is an important part of st and ard care and treatment for acute myocardial infa rct ion in patients . Evidence exists indicating that acute myocardial infa rct ion patients experience an information gap in the period immediately after discharge from the hospital . The aim of this study was to assess the short-term effects of a nurse-led telephone follow-up intervention to provide information and support to patients with acute myocardial infa rct ion after their discharge from hospital . Design and method A prospect i ve r and omized , controlled trial with a 6-month follow-up was conducted . A total of 288 patients were allocated to either an intervention group ( n = 156 ) or a control group ( n = 132 ) . The latter received routine post-discharge care . The primary endpoint measured at 3 and 6 months after discharge was the health-related quality of life using the 36-item Short Form Health Survey . Secondary endpoints included smoking and exercise habits . Results In both groups , health-related quality of life improved significantly over time on most subscales . A statistically significant difference in favour of the intervention group was found on the 36-item Short Form Health Survey Physical Health Component Summary Scale ( P=0.034 ) after 6 months . No difference was found between the groups on the Mental Health Component Summary Scale . We found a significant difference with respect to frequency of physical activity in favour of the intervention group after 6 months ( P=0.004 ) . More participants in the intervention group than the control group had ceased smoking at the 6-month follow-up ( P=0.055 ) . Conclusion A nurse-led systematic telephone follow-up intervention significantly improved the physical dimension of health-related quality of life in patients in the intervention group compared with usual care patients . Participation in this intervention also seemed to promote health behaviour change in patients after acute myocardial infa rct ion This study examined the effectiveness of a nurse-managed minimal-contact smoking cessation intervention for patients hospitalized for cardiac disease . A pre-test-post-test quasi-experimental design was used . Patients who smoked prior to admission to cardiac wards of five hospitals ( n = 388 ) received the intervention , whereas smoking patients in six other hospitals were given usual care ( n = 401 ) . The intervention was initiated at the hospital and continued after discharge . The core elements were stop-smoking advice from the cardiologist , a short bedside consultation with a nurse , administration of self-help material s and aftercare by the cardiologist . Smoking cessation was assessed after 3 months by self-report . Logistic regression analysis excluding dropouts , controlling for covariates including baseline differences showed significant intervention effects ( one-tailed significance test ) on point prevalence abstinence ( OR = 2.11 ) and continuous abstinence ( OR = 1.41 ) . Intention-to-treat analysis including dropouts as smokers showed a significant effect on point prevalence abstinence ( OR 1.35 ) . We conclude that , compared to usual care , the low-intensity smoking cessation intervention for cardiac in patients was more effective in achieving smoking cessation . However , the small effects and the process evaluation suggest that improvements are needed Cigarette reduction has been proposed as a treatment goal for smokers who are not interested in stopping completely . This r and omized controlled trial was design ed to determine the effect of a smoking reduction intervention on smoking behavior , symptoms of heart disease , and biomarkers of tobacco exposure . It included 152 patients with heart disease who did not intend to stop smoking in the next 30 days . Participants were r and omly assigned to smoking reduction ( SR ) or usual care ( UC ) . SR subjects received counseling and nicotine replacement therapy to encourage > or = 50 % reduction in cigarettes per day ( CPD ) . They were followed at 1 , 3 , 6 , 12 and 18 months to assess smoking , heart disease symptoms , quality of life and nicotine , cotinine , carbon monoxide ( CO ) , white blood cell ( WBC ) count , fibrinogen , hs-C-reactive protein ( hs-CRP ) , F2-isoprostane , 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides ( total NNAL ) , and 1-hydroxypyrene ( 1-HOP ) . At 6 months SR participants reduced by 10.9 CPD , compared with 7.4 CPD in UC ( difference NS ) . At 18 months , 9/78 SR vs. 9/74 UC participants quit smoking . There were no significant differences between treatment groups in angina , quality of life or adverse events , nicotine , cotinine , CO , WBC count , fibrinogen , hs-CRP , F2-isoprostane , total NNAL or 1-HOP levels at any time point . To determine if smoking reduction , regardless of treatment condition , was associated with improved outcomes , we compared all subjects at 6 months to baseline ( mean reduction in CPD from 27.4 to 18.1 , p<.01 ) . There were no significant changes in outcome variables except CO , which decreased by 5.5 ppm ( p<.01 ) . There were also no significant improvements considering only subjects who reduced by > or = 50 % , or those who had no history of reduction prior to enrollment in the study . The SR intervention did not significantly reduce CPD or toxin exposure , or improve smoking cessation or clinical outcomes compared to UC . These results emphasize the importance of abstinence for smokers with heart disease to minimize health risks from tobacco PURPOSE Smoking cessation is an important goal for smokers with coronary artery disease ( CAD ) because it reduces cardiac morbidity and mortality . Effective interventions for cigarette smokers with CAD exist , but they often are considered to be intensive and expensive . Stepped-care interventions have been proposed as a promising way to allocate smoking cessation treatments in a cost-effective manner . Stepped care refers to the practice of initiating treatment with low-intensity intervention and then exposing treatment failures to successively more intense interventions . METHODS To address the efficacy of this approach , 254 cigarette smokers hospitalized with CAD were provided a brief cessation intervention . The participants then were assigned r and omly to either a more intensive stepped-care treatment ( counseling and nicotine patch therapy ) or no additional treatment . Outcomes were point-prevalent abstinence measured 3 months and 1 year after hospital discharge . RESULTS Stepped-care treatment increased smoking cessation rates from 42 % to 53 % during a 3-month follow-up period ( P = .05 ) , but showed little effect at the 1-year follow-up assessment , as evidence d by a cessation rate for the minimal intervention group of 36 % versus 39 % for the stepped-care group ( P = .36 ) . CONCLUSIONS A stepped-care approach to smoking cessation increased short-but not long-term point-prevalent abstinence in patients with CAD . For improvement of long-term effectiveness , refinement of the timing and content of stepped-care interventions needs to occur Background : Classification of smoking status has a major impact on the conclusions drawn from smoking cessation intervention research , yet few studies have addressed this critical issue . Objectives : The aim of this study was to compare three classifications ( naïve , optimistic , and pessimistic ) of smoking cessation outcomes or smoking status from the Women 's Initiative for Nonsmoking Study ( WINS ) . Methods : This is a longitudinal prospect i ve study nested within a r and omized clinical trial ( RCT ) design of WINS , an RCT of 277 women over the age of 18 years who reported smoking cigarettes continuously for 1 month prior to a cardiovascular event requiring hospital admission . Women were r and omized to either the usual care group ( UC ) or the intervention group ( IG ) . Recruitment for WINS occurred between October 1996 and December 1998 in 10 hospitals in the San Francisco Bay area . Follow-up data on smoking status was obtained from the UC and the IG using a structured telephone interview at 6 and 12 months from baseline and was confirmed by family members and salivary cotinine levels . Results : Seven-daypointprevalence(self-report of not smoking in the past 7 days ; " not even a puff " ) using the naïve ( the most liberal ) classification yields a greater number of nonsmokers than the pessimistic or most conservative classification ( cotinine level verification of smoking status ) . The classification of smoking status also affects time to continuous smoking . The pessimistic classification results in the shortest time to continuous smoking , whereas the opposite is observed with the naïve classification . Discussion : It is important to critically evaluate the underlying assumptions made by study investigators when measuring and reporting smoking status . The classification of smoking status and the selection of analysis , meaning point prevalence versus survival analysis , affect study results and contribute to the variability observed in the research findings of smoking cessation intervention trials and the challenges faced in making appropriate comparisons across studies STUDY OBJECTIVES Smoking cessation for current smokers is a health-care imperative . It is not clear which approaches to smoking cessation are the most effective in the hospital setting and which factors predict long-term abstinence . We hypothesized that a hospital-based smoking cessation program involving behavioral modification and support would provide an effective intervention for smoking cessation . DESIGN Prospect i ve cohort study . SETTING Smoking cessation clinics in a tertiary referral , cardiothoracic hospital . PATIENTS OR PARTICIPANTS Two hundred forty-three smokers and 187 never-smoker control subjects . INTERVENTIONS Smokers underwent specific sessions of individual counseling on behavioral modification , including written information , advice about quit aids , and support during the quit attempt . Abstinence was confirmed by exhaled carbon monoxide measurements . MEASUREMENTS AND RESULTS Compared to never-smoker control subjects , smokers were more likely to have grown up with a smoking father or siblings , and to currently live or socialize with other smokers . Two hundred sixteen smokers attended at least two sessions of the smoking cessation program . Of these , 25 % were unavailable for follow-up at 12 months and were assumed to be smoking . The point prevalence abstinence rate at 12 months was 32 % . Independent factors associated with abstinence at 12 months were self-belief in quitting ability , having a heart condition , growing up without siblings who smoked , and increasing number of pack-years . CONCLUSIONS This prospect i ve study has demonstrated that this hospital-based smoking cessation program was as effective as programs in other setting s. Social and psychological factors were associated with a greater chance of abstinence Background Telephone counseling in chronic disease self-management is increasing , but has not been tested in studies that control for quality of medical care . Objective To test the effectiveness of a six-session outpatient telephone-based counseling intervention to improve secondary prevention ( behaviors , medication ) in patients with acute coronary syndrome ( ACS ) following discharge from hospital , and impact on physical functioning and quality of life at 8 months post-discharge . Design Patient-level r and omized trial of hospital quality improvement ( QI-only ) versus quality improvement plus brief telephone coaching in three months post-hospitalization ( QI-plus ) . Data : medical record , state vital records , patient surveys ( baseline , three and eight months post-hospitalization ) . Analysis : pooled-time series generalized estimating equations to analyze repeated measures ; intention-to-treat analysis . Participants Seven hundred and nineteen patients admitted to one of five hospitals in two contiguous mid-Michigan communities enrolled ; 525 completed baseline surveys . Measurements We measured secondary prevention behaviors , physical functioning , and quality of life . Results QI-plus patients showed higher self-reported physical activity ( OR = 1.53 ; p = .01 ) during the first three months , with decline after active intervention was withdrawn . Smoking cessation and medication use were not different at 3 or 8 months ; functional status and quality of life were not different at 8 months . Conclusions Telephone coaching post-hospitalization for ACS was modestly effective in accomplishing short-term , but not long-term life-style behavior change . Previous positive results shown in primary care did not transfer to free-st and ing telephone counseling as an adjunct to care following hospitalization BACKGROUND Few research studies have evaluated the effectiveness of smoking interventions in hospitalized patients . This r and omized controlled trial compared the efficacy of 2 smoking cessation programs in patients hospitalized in 4 community hospitals in a large health maintenance organization within the San Francisco Bay Area in California . METHODS Patients were r and omly assigned to usual care ( n = 990 ) , nurse-mediated , behaviorally oriented inpatient counseling focused on relapse prevention with 1 postdischarge telephone contact ( minimal intervention , n = 473 ) , or the same inpatient counseling with 4 postdischarge telephone contacts ( intensive intervention , n = 561 ) . The main outcome measure , smoking cessation rate , was corroborated by plasma cotinine determination or family confirmation , 1 year after enrollment . RESULTS At 1 year smoking cessation rates were 27 % , 22 % , and 20 % for intensive intervention , minimal intervention , and usual care groups , respectively ( P = .009 for intensive vs usual care ) . Subgroup analyses by diagnosis revealed that the odds of cessation among patients with cardiovascular disease or other internal medical conditions were greater among those receiving the intensive intervention than among their counterparts receiving usual care ( odds ratios , 1.6 and 2.0 , respectively ) . CONCLUSIONS A multicomponent smoking cessation program consisting of physician advice ; in-hospital , nurse-mediated counseling ; and multiple postdischarge telephone contacts was effective in increasing smoking cessation rates among hospitalized smokers . Hospital-wide smoking cessation programs could substantially increase the effectiveness of hospital smoking bans BACKGROUND This study evaluated the effectiveness of three smoking cessation interventions for this population : ( 1 ) modified usual care ( UC ) ; ( 2 ) brief advice ( A ) ; and ( 3 ) brief advice plus more extended counseling during and after hospitalization ( A + C ) . METHODS Smokers ( 2,095 ) who were in- patients in four hospitals were r and omly assigned to condition . Smoking status was ascertained via phone interview 7 days and 12 months post-discharge . At 12 months , reports of abstinence were vali date d by analysis of saliva cotinine . Intent to treat analyses were performed . RESULTS At 7-day follow-up , 24.2 % of participants reported abstinence in the previous 7 days . There were no differences between conditions . At 12-month follow-up , self-reported abstinence was significantly higher in the A + C condition ( UC ( 15.0 % ) vs. A ( 15.2 % ) vs. A + C ( 19.8 % ) ) . There was no significant difference among conditions in cotinine-vali date d abstinence , however ( UC ( 8.8 % ) vs. A ( 10.0 % ) vs. A + C ( 9.9 % ) ) . CONCLUSIONS These interventions for hospital in- patients did not increase abstinence rates . Features of the study that might have contributed to this finding were the inclusiveness of the participation criteria , the fact that pharmacological aids were not provided , and a stage-matching approach that result ed in less intensive counseling for participants unwilling to set a quit date Background —Although men hospitalized with cardiovascular disease ( CVD ) show high smoking-cessation rates , similar data for women are lacking . We tested the efficacy of smoking-cessation intervention in women hospitalized for CVD . Methods and Results —In this r and omized controlled trial conducted from 1996 to 2001 , 277 women diagnosed with CVD ( mean age 61±10 years ) were r and omly assigned within 1 of 12 San Francisco Bay Area hospitals to a usual-care group ( UG ; n=135 ) or intervention group ( IG ; n=142 ) . Baseline histories were obtained , and interviews to ascertain self-reported smoking status occurred at 6 , 12 , 24 , and 30 months after hospitalization . The UG received strong physician ’s advice , a self-help pamphlet , and a list of community re sources . The IG received strong physician ’s advice and a nurse-managed cognitive behavioral relapse-prevention intervention at bedside , with telephone contact at intervals after discharge . The groups were similar demographically and had smoked cigarettes for a median of 38 ( IG ) or 40 ( UG ) years . Time to resumption of continuous smoking was assessed by Kaplan-Meier analysis , and risk differences between groups were determined . Time smoke-free was significantly greater for the IG than the UG ( P = 0.038 ) . Point prevalence for nonsmoking at the interviews was somewhat greater for the IG than the UG ( P > 0.15 at all times ) . Conclusions —Cognitive behavioral intervention result ed in longer average times to resumption of smoking , but in these 2 groups of older women with limited social and financial re sources , long-term success rates were similar . Systematic identification of smokers and even the brief intervention afforded the UG yielded a high smoking-cessation rate over time OBJECTIVES Previous research has documented that hospital-based smoking-cessation counseling is efficacious and cost-effective when delivered by research staff . This study evaluated the implementation and effectiveness of this intervention program when delivered by respiratory therapists chosen from the regular hospital staff . METHODS A total of 1,173 hospitalized smokers were r and omly assigned to either usual care or a stage-based bedside counseling program supplemented with a videotape , self-help material s , and a follow-up telephone call . RESULTS Using an intent-to-treat analysis and counting those lost to follow-up as smokers , we did not find a significant difference in outcome between intervention ( 14.2 % reported being abstinent for > or = 6 months at the 1-year follow-up ) and usual care conditions ( 13.6 % abstinence ) . Process analyses revealed that these results were due to a combination of failure to reach many patients and reduced effectiveness of respiratory therapist interventionists compared with experienced professional counselors in a previous study conducted in the same hospitals . CONCLUSIONS We recommend implementation of hospital-based smoking-cessation counseling by professional counselors whose primary responsibility is to deliver the intervention . Recommendations for future research and for innovative ways to reach hospitalized smokers who are not receiving intervention are discussed A group of 93 coronary patients recently treated with percutaneous transluminal coronary angioplasty ( PTCA ) were r and omly assigned to either an intervention or a control group . Subjects in the intervention group participated in a comprehensive behaviorally oriented program aim ed at achieving significant long-term changes in risk factor-related lifestyle behavior . Assessment s of lifestyle behaviors , psychological factors , biological risk factors , and rehabilitation as well as secondary prevention endpoints were carried out , at inclusion and after 12 months . Results showed that the intervention patients , as compared with controls , improved significantly on measures assessing smoking , exercise , and diet habits . These self-rated changes were confirmed by weight reductions and improved exercise capacity , as well as by between-group differences in sub clinical chest pain during an exercise test . However , few effects were found on the different psychological variables , as well as on morbidity or return to work Seventy-four cigarette-smoking patients admitted with COPD to the Chest Unit of a 600-bed teaching hospital served as subjects for a r and omized trial of smoking cessation counseling . All patients were advised to quit smoking and smoking in the unit was not allowed . One-half of the patients were , in addition , provided with a self-help manual and three to eight 15- to 20-min counseling sessions on alternate days while in hospital . Self-reports of smoking status were obtained at 3 and 6 months , a sample of which were vali date d with serum COHb . The results were disappointing . Differences between the counseled group and the controls both in rates of cessation at 6 months ( 33.3 % vs 21.4 % ) and , for patients still smoking , reductions in amount smoked would have lacked practical significance even if statistical significance had been obtained . Some alternative treatment approaches are suggested for this group of patients INTRODUCTION Bupropion is a first-line pharmacological aid for smoking cessation ; however , no clinical trials have been conducted in a general population of hospitalized smokers . METHODS We enrolled 85 smokers in a hospital-based r and omized smoking cessation trial conducted at the San Francisco Veterans Affairs Medical Center . A total of 42 participants received a 7-week course of sustained-release bupropion and 43 participants received placebo . All participants received cognitive-behavioral counseling . We screened 14,997 patients , of whom 25 % were current smokers . Of the 536 smokers who met the entry criteria , 451 opted not to enroll . We determined on-medication , end-of-medication , 3-month , and 6-month smoking cessation rates . RESULTS At the end of 7 weeks of drug treatment , self-reported quit rates were equivalent in the bupropion and placebo arms , 37 % versus 33 % , respectively ( p = .82 ) . The vali date d quit rates for the bupropion and placebo groups were 27 % versus 29 % , respectively ( p = 1.00 ) . At 6 months , the self-reported quit rates were 29 % in the bupropion group and 41 % in the placebo group ( p = .36 ) . In a comparison of 6-month quit rates , vali date d either by salivary cotinine or by spousal proxy , we found nonsignificantly higher quit rates in the placebo group than in the bupropion group , 31 % versus 15 % ( p = .12 ) . DISCUSSION The addition of sustained-release bupropion to counseling did not increase quit rates , but the study was underpowered . Because of the secular trend toward shorter hospital stays , recruitment was very difficult , raising questions regarding the feasibility of future hospital-based smoking cessation trials and interventions Objective : Does the provision of a nurse‐based intervention lead to smoking cessation in hospital patients OBJECTIVE The purpose of this study was to assess the use of nicotine replacement therapy ( NRT ) in a nurse-managed smoking cessation program . DESIGN A cohort design nested within the WINS r and omized clinical trial was used with follow-up at 2 , 7 , 21 , 28 , and 90 days . SETTING The study took place in 10 hospitals in the San Francisco Bay Area . SUBJECTS Participants included 142 women hospitalized with cardiovascular disease ( CVD ) . OUTCOME MEASURE The outcome measure was the use of NRT after having been assessed as eligible for its use . INTERVENTION NRT was used as an adjunct in the behavioral intervention protocol . NRT was recommended during the hospital intervention and during the 90-day outpatient phase . RESULTS Of 142 women in the intervention group , 127 met the criteria for NRT use . During the 5 follow-up assessment s , the reported NRT use ranged from 9 % to 22 % . CONCLUSION A low NRT use rate among women with CVD is evident . The results suggest that future research about NRT myths pertaining to women is needed . Nurses can help patients dispel these myths and prevent smoking relapse in women with CVD OBJECTIVE To assess the effect of physician counseling and referral on smoking cessation rates and attendance at a smoking cessation program . METHODS This was a prospect i ve , r and omized clinical trial set in a suburban , community teaching hospital emergency department ( ED ) . During study hours , dedicated research associates enrolled consecutive , stable , oriented patients who were smokers . Eligible , consenting patients were r and omized to one of two intervention groups . The control group received a two-page " Stop Smoking " pamphlet from the American Heart Association ( AHA ) . Patients in the intervention group were given the AHA pamphlet along with pharmacologic information and st and ardized counseling by the attending emergency physician , including written and oral referral to a smoking cessation program . The primary outcome measures were telephone contact/attendance at the smoking cessation program by the intervention group and the rate of smoking cessation in both study groups at three months post-ED visit . Categorical data were analyzed by chi-square and Fisher 's exact tests . Rank data were analyzed by Mann-Whitney tests and continuous data by t-tests . All tests were two-tailed with alpha set at 0.05 . RESULTS One hundred fifty-two patients were enrolled ; 78 were r and omized to the intervention group . Nearly 70 % of patients ( 103 ) were available for telephone follow-up . The study groups were statistically similar with regard to baseline demographic characteristics and the prevalence of moderate or severe nicotine addiction . None of the patients ( 0 % ) in the intervention group contacted or attended the smoking cessation program during the study period ( 95 % CI = 0 - 4 % ) . The percentages of patients who stopped smoking after three months were similar in the two groups [ 10.4 % ( 5/48 ) control vs 10.9 % ( 6/55 ) intervention ; p = 1 ] . CONCLUSION The authors found no difference in the smoking cessation rates between ED patients who received written material and those who were counseled by emergency physicians . Referral of patients who smoked to a cessation program was unsuccessful BACKGROUND This study was undertaken to assess the safety and efficacy of a treatment involving brief counseling and the nicotine patch among hospital in patients and to identify variables associated with long-term smoking cessation following hospitalization . METHODS One hundred eighty-five patients were r and omly assigned to one of three smoking cessation interventions : ( 1 ) A Minimal Care ( MC ) condition , consisting of a brief physician-delivered motivational message to stop smoking , ( 2 ) a Counseling + Active Nicotine Patch ( CAP ) condition in which patients received the motivational message , a 6-week supply of nicotine patches , and extended bedside and telephone counseling , and ( 3 ) a Counseling + Placebo Patch ( CPP ) condition identical to the CAP condition except the supplied patches contained no nicotine . RESULTS At 6-month follow-up , abstinence rates for the three treatments were 4.9 , 6.5 , and 9.7 % for the MC , CPP , and CAP treatments , respectively . These differences were not statistically significant . Patients admitted for respiratory disease were more likely to quit than patients with any other diagnosis . The nicotine patch was well tolerated by hospital in patients . CONCLUSIONS The initiation of nicotine patch therapy during hospitalization appears to be safe when used among patients carrying a wide range of diagnoses . Our study provided no evidence of the superiority of nicotine patches versus placebo , but this does not preclude the possibility that future research using larger sample s might detect differences between patch groups . Hospital interventions for smoking cessation may be most effective among patients hospitalized for a smoking-related illness such as respiratory disease Background Smoking cessation is probably the most important single action after a coronary event . In order to increase the effectiveness of smoking cessation programs , it is important to have knowledge of the predictors of smoking cessation . Further , it is unknown whether smoking cessation programs have impact on these predictors . Methods Data were obtained from a r and omized controlled trial of smoking cessation intervention in 240 smokers aged less than 76 years admitted for myocardial infa rct ion , unstable angina , or cardiac bypass surgery . Baseline characteristics were prospect ively recorded . Smoking cessation was determined by self report and biochemical verification at 12 months follow-up . Results In multivariate logistic regression analysis , a high level of nicotine addiction , low level of self-confidence in quitting and having previous coronary heart disease were significant negative predictors of smoking cessation at 12 months follow-up . Having previous coronary heart disease and a diagnosis other than acute myocardial infa rct ion as a reason for admission were important negative predictors of abstinence in the usual care group , in contrast to the intervention group , although this did not reach a level of significance in the subgroup interaction analyses . A high level of nicotine addiction was a strong negative predictor in both groups . Conclusion A high level of nicotine addiction is an important negative predictor of smoking cessation , even within an individualized smoking cessation program . Smoking cessation intervention seems to be especially effective in patients with previous coronary heart disease and in patients with unstable angina or coronary artery bypass surgery , compared to usual care The purpose of this study was to evaluate the effect of a nurse-directed smoking cessation intervention for adults hospitalized in a small community hospital using a quasiexperimental , prospect i ve , longitudinal design with biochemical validation of self-reported tobacco abstinence . Sixty-eight in patients were assigned to either a control ( n = 30 ) or an intervention group ( n = 38 ) . The control group received smoking cessation literature . The intervention group received smoking cessation literature and a nursing intervention . Each member of the intervention group was r and omly assigned to a one or four telephone call subgroup for post discharge nurse follow-up at 3 months . Fifty-five participants completed the study . Smokers receiving the nurse-directed intervention were significantly more likely to be tobacco abstinent at 3 months ( n = 17 , 55 % ) than smokers in the control group ( n = 5 , 21 % ) . Within the intervention group , tobacco abstinence at 3 months was not significantly different between the one and four telephone call groups . For the total sample , smoking relapse was significantly higher for participants who lived with another smoker This pilot study investigated the efficacy of initiating a smoking cessation intervention early in inpatient treatment for alcohol dependence versus shortly after an inpatient stay . Thirty-six male smokers recruited from an inpatient substance abuse treatment program were r and omly assigned to begin smoking cessation either two weeks ( concurrent treatment ) or six weeks ( delayed treatment ) after admission to the substance abuse program . Smoking cessation treatment involved three sessions of individual smoking cessation treatment plus eight weeks of transdermal nicotine replacement . Significantly fewer participants began the delayed treatment than the concurrent treatment . Few participants were smoking-abstinent at follow-up , and the timing of treatment onset did not have an impact on smoking outcome . Clinical trials with larger sample s may be needed to better evaluate the efficacy of concurrent versus delayed treatment and to test the efficacy of more aggressive interventions with smokers in early alcohol recovery The Timing of Alcohol and Smoking Cessation ( TASC ) Study is a r and omized controlled trial that examines the optimal timing of intervention for nicotine dependence in patients with alcohol use disorders . A cross-sectional analysis of baseline characteristics of study participants was used to identify characteristics associated with readiness of patients in intensive treatment for alcohol abuse or dependence to quit smoking . Baseline characteristics of 499 subjects enrolled in the TASC trial were analyzed . Readiness to quit was assessed by two self-rated measures : being in the preparation/action stages of change and scoring at least an 8 on the Contemplation Ladder . Univariate analyses showed a higher prevalence of African-Americans and other minorities than Caucasian , among participants planning to quit in the next month ( p = 0.005 ) . There were no other differences between groups . Participants in the preparation/action stages of change experienced significantly lower rates of current ( p = 0.011 ) and past ( p = 0.014 ) major depressive disorder and displayed significantly less current depressive symptoms on the Beck Depression Inventory ( p = 0.008 ) . Patients with Contemplation Ladder ratings between 8 and 10 showed similar results . Logistic regression models consistently confirmed that the degree of depression was negatively associated with the intention to quit , but different models suggested that increasing age , shorter duration of smoking history , race other than white , and a greater number of past quit attempts were positively associated with readiness to quit . Among patients in intensive treatment for alcohol use disorders who smoke , a history of depressive disorder and depressive symptoms predict less interest in quitting smoking PURPOSE Smoking cessation after myocardial infa rct ion reduces cardiovascular mortality , but many smokers can not quit despite state-of-the-art counseling intervention . Bupropion is effective for smoking cessation , but its safety and efficacy in hospitalized smokers with acute cardiovascular disease is unknown . METHODS A five-hospital r and omized double-blind placebo-controlled trial assessed the safety and efficacy of 12 weeks of sustained-release bupropion ( 300 mg ) or placebo in 248 smokers admitted for acute cardiovascular disease , primarily myocardial infa rct ion and unstable angina . All subjects had smoking counseling in the hospital and for 12 weeks after discharge . Cotinine-vali date d 7-day tobacco abstinence , cardiovascular mortality , and new cardiovascular events were assessed at 3 months ( end-of-treatment ) and 1 year . RESULTS Vali date d tobacco abstinence rates in bupropion and placebo groups were 37.1 % vs 26.8 % ( OR 1.61 , 95 % CI , 0.94 - 2.76 ; P=.08 ) at 3 months and 25.0 % vs 21.3 % ( OR , 1.23 , 95 % CI , 0.68 - 2.23 , P=.49 ) at 1 year . The adjusted odds ratio , after controlling for cigarettes per day , depression symptoms , prior bupropion use , hypertension , and length of stay , was 1.91 ( 95 % CI , 1.06 - 3.40 , P=.03 ) at 3 months and 1.51 ( 95 % CI , 0.81 - 2.83 ) at 1 year . Bupropion and placebo groups did not differ in cardiovascular mortality at 1 year ( 0 % vs 2 % ) , in blood pressure at follow-up , or in cardiovascular events at end-of-treatment ( 16 % vs 14 % , incidence rate ratio [IRR]1.22 ( 95 % CI : 0.64 - 2.33 ) or 1 year ( 26 % vs 18 % , IRR 1.56 , 95 % CI 0.91 - 2.69 ) . CONCLUSIONS Bupropion improved short-term but not long-term smoking cessation rates over intensive counseling and appeared to be safe in hospitalized smokers with acute cardiovascular disease A hospitalization is a time when perceived vulnerability to dangers from smoking and quitting motivation may be at their peak . Aim was to determine whether a smoking cessation intervention of moderate intensity would increase the smoking cessation rate in hospitalized smokers . Design was r and omized trial , conducted in a university-affiliated cardio-pulmonary tertiary care center . Participants were hospitalized smokers aged < or = 70 years . Intervention was a smoking cessation intervention consisting of education and psychological support , with or without pharmacological therapy , associated with follow-up phone calls . Patients assigned to the control group received usual care . Measurement was point prevalence cessation rate at 1-year follow-up . A total of 468 patients were screened ; 196 were r and omized . Although the smoking cessation rates at 12-month follow-up were higher than expected , we found no significant difference between the study groups ( intervention : 30.3 % ; control : 27.8 % ) . Similar results were obtained in patients whose smoking status was vali date d by urinary cotinine assay . Length of stay and dependence to nicotine were the only significant predictors of smoking cessation . A smoking cessation intervention of moderate intensity delivered in a tertiary cardio-pulmonary center did not increase the smoking cessation rate at 1-year follow-up . The results of this trial should not divert those who deliver care to in patients from delivering a brief smoking cessation intervention Abstract . There has been little research on smoking cessation after critical illness . Smokers make up a high percentage of patients admitted to intensive care ( ICU ) and stopping smoking is one message that should be clearly given to recovering patients . The recovery period provides an important opportunity for patients to quit smoking as the period of sedation and ventilation allows patients to start nicotine withdrawal . Smoking cessation advice was included in a 6-week self-help ICU rehabilitation package comprising information and an exercise programme . Recovering ICU patients were r and omised to receive either the routine follow-up of ward visits and ICU clinic appointments or routine follow-up plus the ICU rehabilitation package . Twenty out of thirty-one intervention patients and 16/30 control patients were smokers pre-ICU admission . At the 6-month follow-up , previous smokers given the rehabilitation package had a relative risk reduction for smoking of 89 % ( CI 98%–36 % ) . Smoking cessation after critical illness is aided by the provision of a rehabilitation programme AIMS An earlier combined proactive and reactive telephone follow-up intervention for acute myocardial infa rct ion patients after discharge from hospital showed positive effects after six months . The aim of the present study was to assess whether the intervention has long-term effects up to 18 months after discharge . DESIGN A prospect i ve r and omised controlled trial with 18 months follow-up . METHOD The trial was conducted with 288 patients allocated to a telephone follow-up intervention group ( n = 156 ) or control group ( n = 132 ) . The primary endpoint was health-related quality of life using the SF-36 . Secondary endpoints included smoking and exercise habits , return to work and rehospitalisation due to chest pain . RESULTS There were significant improvements over time on most dimensions of health-related quality of life in both the intervention and control group to US norm population levels on most SF-36 dimensions and summary scores . The intervention group showed no overall significant improvement beyond six months in the physical or mental summary scores , but there was a significant effect for those aged 70 or above . Although there was a promising effect for rehospitalisation due to chest pain , no significant differences were found between the groups on the secondary endpoints after six months . CONCLUSION This study demonstrated that despite positive short-term effects at six months , the telephone follow-up intervention had no long-term effects on health-related quality of life or secondary endpoints . However , the potential for improvement beyond six months was less than anticipated reflecting a reduced morbidity among acute myocardial infa rct ion patients . RELEVANCE TO CLINICAL PRACTICE Telephone follow-up after discharge from hospital is an easy implementable follow-up intervention enabling individualised provision of information and support in a time often experienced as stressful by patients . Our study indicates that six months is an adequate support period . Despite positive results six months after discharge no significant added long-term effects of telephone follow-up , compared to usual care were found in this study BACKGROUND Hospitalization may be an opportune time to change smoking behavior because it requires smokers to abstain from tobacco at the same time that illness can motivate them to quit . A hospital-based intervention may promote smoking cessation after discharge . METHODS We tested the efficacy of a brief bedside smoking counseling program in a r and omized controlled trial at Massachusetts General Hospital , Boston . The 650 adult smokers admitted to the medical and surgical services were r and omly assigned to receive usual care or a hospital-based smoking intervention consisting of ( 1 ) a 15-minute bedside counseling session , ( 2 ) written self-help material , ( 3 ) a chart prompt reminding physicians to advise smoking cessation , and ( 4 ) up to 3 weekly counseling telephone calls after discharge . Smoking status was assessed 1 and 6 months after hospital discharge by self-report and vali date d at 6 months by measurement of saliva cotinine levels . RESULTS One month after discharge , more intervention than control patients were not smoking ( 28.9 % vs 18.9 % ; P=.003 ) . The effect persisted after multiple logistic regression analyses adjusted for baseline group differences , length of stay , postdischarge smoking treatment , and hospital readmission ( adjusted odds ratio , 2.19 ; 95 % confidence interval , 1.34 - 3.57 ) . At 6 months , the intervention and control groups did not differ in smoking cessation rate by self-report ( 17.3 % vs 14.0 % ; P=.26 ) or biochemical validation ( 8.1 % vs 8.7 % ; P=.72 ) , although the program appeared to be effective among the 167 patients who had not previously tried to quit smoking ( 15.3 % vs 3.7 % ; P=.01 ) . CONCLUSIONS A low-intensity , hospital-based smoking cessation program increased smoking cessation rates for 1 month after discharge but did not lead to long-term tobacco abstinence . A longer period of telephone contact after discharge might build on this initial success to produce permanent smoking cessation among hospitalized smokers Background : Smoking cessation of patients with cancer can improve treatment efficacy and survival . Objective : To determine whether a motivational interviewing intervention increased successful smoking cessation attempts of patients with cancer attending a South Australian public hospital , as compared with usual care . Methods : A r and omized controlled trial was used to study 137 patients with mixed cancer sites , including 74 intervention patients and 63 control patients . The motivational interviewing intervention was delivered over a 3-month period . The intervention included a visit with a smoking cessation counselor , provision of smoking cessation booklets , nicotine replacement therapy , family advice to quit , and an in-person or telephone follow-up conversation . Results : At the 6-month follow-up visit , an intention-to-treat analysis found no difference in biochemically confirmed 3-month prevalence quit rates between the intervention ( 5 % ) and control ( 6 % ) groups . A sensitivity analysis using more lenient criteria indicated quit rates of 29 % for the intervention group and 18 % for the control group ( p = .32 ) . The predictors of smoking cessation at 6 months for all the patients included a smoking-related cancer site , more cessation attempts in the year before enrollment in the study , and no radiation therapy . Conclusions : Future efforts to improve smoking cessation in this patient group might focus on the delivery of more direct methods for encouraging spouse cessation and support to the patient in quitting , and the use of bupropion ( Zyban ) as an adjunct to cessation for this heavy smoking patient group Hospitalization represents a teachable moment for quitting . The current study examined predictors of quitting among hospitalized smokers . Patients reported smoking history and demographic characteristics during in-hospital baseline interviews . Discharge diagnosis also was collected . Smoking status was ascertained in interviews at 7 days and at 12 months after discharge . A total of 2,350 patients in four Minneapolis and St. Paul ( Twin Cities ) , Minnesota , area hospitals participated in the study ; 1,477 patients who provided data at both follow-ups and whose 12-month self-report of quitting was corroborated by cotinine analysis of saliva sample s were included in the current analyses . Predictors of both short- and long-term abstinence in the multivariate analysis included smoking-related illness , age ( those who were older were more likely to be abstinent ) , stage of change ( precontemplators were least likely to quit , and those initially in action were most likely to quit ) , and time to first cigarette ( those who reported smoking within 5 min of awakening were least likely to quit ) . The predictors presented few surprises ; the most important finding may have been that the experience of hospitalization itself led to substantial long-term quitting for virtually all categories of hospitalized smokers Asking smokers about their smoking status , followed by advice to quit smoking , assessing the intention to quit , assistance with cessation , and arrange of follow-up ( 5A ) is recommended for induction of smoking cessation . To obtain preliminary data on effects of " 5A " , we investigated the smoking cessation rate with two modes in the phase I : 1 ) self-administered question naire and 2 ) doctor 's interview at respiratory disease clinics of three general hospitals in Japan , and another mode in phase II : 3 ) doctor 's interview with an additional pamphlet at one of the three hospitals . The interviews for smokers were conducted by doctors in charge of treatment . Subject smoking habits were followed up by postal surveys three months after the enrollment . In phase I , 359 out patients were recruited and 189 smokers responded , among whom 27 patients ( 7.5 % of 359 out patients ) had quit smoking at the three months after the enrollment . The cessation rate of the self-administered question naire group ( 8.4 % of 238 smokers ) did not differ significantly from that of doctors ' interview group ( 5.8 % of 121 smokers ) . Age and intention to quit at enrollment were found to be independent predictors of smoking cessation . Patients aged 50 years or older ( odds ratio=5.05 , 95 % confidence interval 1.89 - 13.54 ) , and participants with an intention to quit ( odds ratio=6.78 , 95 % confidence interval 2.66 - 17.30 ) were more likely to be successful in quitting . In phase II , another 212 smokers of one hospital were interviewed by doctors in charge and provided with an additional pamphlet describing how to practice to dislike smoking . No significant difference in the cessation rate was observed between phase I and phase II ( 5.8 % vs. 8.0 % ) . In conclusion , there were no differences among the three modes of " 5A " , but 7.7 % of the 571 out patients visiting respiratory divisions quit smoking with this simple " 5A " . The findings may indicate that this simple practice at clinics is useful for smoking cessation strategy , although r and omized trials are now required PURPOSE To identify predictors of long-term cessation after intervention for woman hospitalized with cardiovascular diseases ( CVD ) . METHODS A r and omized clinical trial ( RCT ) with a 30-month follow-up was conducted , recruiting 277 woman smokers with CVD from 10 hospitals . The intervention consisted of inpatient and outpatient counseling on smoking cessation and pharmacological protocol . Psychophysiological factors and time since quitting associated with relapse in the literature were assessed in our prediction model . RESULTS The nine independent variables for smoking relapse included time since quitting , group assignment , the interaction between time and group assignment , serious quit attempts and five and psychophysiological factors . Lower self-efficacy at baseline was a significant predictor of relapse ( OR = 0.98 , 95%CI = 0.97,0.99 ) . Another predictor was the interaction between time and group assignment and the finding showed that for the usual care group , increase in time since quitting provided a significant protective factor ( OR = 0.69 , 95%CI = 0.60,0.79 ) . CONCLUSIONS Cessation programs should include content on self-efficacy to help prevent relapse . The interaction between time and group warrants further investigation for its prediction for relapse Table . SI Units Systematic modification of coronary risk factors is not integrated into the medical care provided to most of the more than 1 million patients treated annually in the United States for acute myocardial infa rct ion by percutaneous transluminal coronary angioplasty or coronary artery surgery . Most of such patients have lipoprotein abnormalities [ 1 ] , and nearly one half smoke [ 2 ] . These risk factors , which contribute to subsequent morbidity and mortality , remain highly prevalent after acute cardiac events . Failure to integrate comprehensive risk factor modification into the st and ard medical care provided to patients after acute cardiac events primarily reflects the lack of an organizational framework or system . This deficiency in re source allocation for preventive and rehabilitative aspects of care in turn reflects the predominant orientation of the U.S. health care system to the management of acute illness [ 3 ] . Several clinical research studies have shown the effectiveness of risk factor modification , especially treatment of lipoprotein abnormalities [ 4 - 7 ] , in achieving regression of coronary artery lesions and reducing the clinical consequences of coronary artery disease [ 6 , 7 ] . However , risk factor interventions shown to be effective in clinical trials may not prove equally effective in clinical practice because of a paucity of re sources , especially nonphysician personnel . The lack of effective management systems limits the expected reduction in morbidity and mortality and the corresponding reduction in medical care costs that motivates current efforts to orient the priorities of the American health care system toward preventive and rehabilitative care . This r and omized , controlled trial compared the effectiveness of a physician-directed , nurse-managed , home-based case-management system for coronary risk factor modification with that of usual medical care . Outcomes were measured in both groups immediately after the end of the first year after acute myocardial infa rct ion . The term case-management system has been used in various context s. As used here , it refers to a system in which a nurse case-manager , working with different health care specialists ( a psychiatrist , a cardiologist , a lipid specialist , a nutritionist , and a nurse coordinator ) , managed coronary risk factors . Methods Enrollment and Orientation Program nurses enlisted patients on hospital day 3 or as soon as their medical condition stabilized . Study participants gave written informed consent to be r and omly assigned to a treatment group . Immediately after r and omization , program nurses introduced patients to the special intervention with the aid of a videotape . Usual Care The 585 patients in our study were cared for by 215 internists and 34 cardiologists in the five participating medical centers who were organized into practice groups of 5 to 10 physicians each . Cardiology consultation was often provided during hospitalization , but primary responsibility for follow-up care was generally assumed by internists . The usual care offered by the Kaiser Permanente Medical Care Program included physician counseling on smoking cessation and nutritionist counseling on dietary change during hospitalization and physician-managed , lipid-lowering drug therapy after hospital discharge . Group outpatient smoking cessation programs were available for a $ 50 fee . Group exercise rehabilitation , not generally provided by the Kaiser Permanente Medical Care Program during this study , was available to patients at various community facilities at an average cost of $ 1800 to $ 2700 for 3 months ' participation . Special Intervention The behavioral interventions in our case-management system , which were offered to the 293 patients in the intervention group in addition to usual care , were derived from social learning theory [ 8 , 9 ] and modified for medical problems [ 10 ] . In this model , persons must learn how to monitor the health habits they seek to change , set attainable sub goals to motivate and direct their efforts , use feedback of progress in ways that promote health , and enlist incentives and social support to sustain the effort needed to succeed [ 8 , 9 ] . In the hospital , patients were instructed on how to complete self-reports [ status reports ] of smoking , dietary intake , and exercise . Scheduled interactions between case managers and patients after discharge took three forms : 1 ) nurse-initiated telephone contacts ; 2 ) computer-generated progress reports mailed to patients based on question naires completed by patients and mailed to the nurses ; and 3 ) visits to the program nurse for treadmill exercise testing , initiation of lipid-lowering drug therapy , if indicated , and a single counseling session after a smoking relapse . The maximum number of treatment contacts during the year , including outcome measurement at 6 and 12 months , was as follows : 14 nurse-initiated telephone contacts , 8 patient visits to the blood chemistry laboratory , and 4 patient visits to the nurse case manager . Smoking Intervention Smoking was defined as the use of cigarettes , cigars , cigarillos , pipe tobacco , or any other form of tobacco in the 6 months before admission . Forty-three percent of patients were smokers . Patients who had smoked during the 6 months before hospitalization received the same intensive smoking cessation intervention during hospitalization ; this intervention has been described previously [ 11 ] . Physicians used a written script that enabled them to provide st and ardized counseling in less than 2 minutes . The hospital-based smoking cessation counseling focused on relapse prevention . Nurses conducted a st and ardized smoking history to evaluate patients ' addiction to smoking . Patients ' reported self-efficacy or confidence to resist smoking in each of 28 potentially high-risk situations was measured ; patients were then counseled on how to manage the situations in which they reported less than 70 % confidence . Patients also received a relapse prevention manual and a relaxation audiotape . They were advised that the nurse would telephone them 48 hours and 1 week after hospital discharge and at monthly intervals for as long as 6 months . Patients who relapsed were offered one additional visit with the nurse for further counseling . Nicotine polacrilex or transdermal nicotine patches were reserved for highly addicted patients who relapsed after hospital discharge . Nutritional Counseling A computer-based expert system developed by the investigators was used to provide nutritional counseling on a National Cholesterol Education Program [ 12 ] Step 2 diet that was low in cholesterol and saturated fat . A food frequency question naire design ed by the investigators was scored using the Cholesterol and Saturated Fat Index developed by Connor and colleagues [ 13 ] . Calculations of cholesterol and saturated fat totals were based on weekly rather than daily average food intakes . Data from the food frequency question naires , mailed by patients to the Stanford coordinating center and entered into a microcomputer , were used to generate progress reports that characterized patients ' dietary patterns , prioritized dietary change goals , and provided guides for managing difficult situations by directing patients to relevant sections of a nutrition workbook entitled Good Eating for Good Health developed by the program nutritionist . Patients in the intervention group completed a food frequency question naire during hospitalization that described their eating habits in the previous month . Patients also completed food frequency question naires 6 , 11 , and 26 weeks after admission . Progress reports were mailed to patients within 48 to 72 hours after the food frequency question naires were received . Detailed strategies for maintenance of dietary change were incorporated into the 26-week progress report . Question naires to evaluate outcomes were also completed at 36 and 52 weeks . Lipid-Lowering Drug Therapy The therapeutic goal of a plasma low-density lipoprotein (LDL)-cholesterol value of 2.46 mmol/L ( 95 mg/dL ) adopted for this trial was based on the mean post-treatment level of LDL cholesterol found in patients in the study by Blankenhorn and colleagues [ 4 ] . Patients with mean plasma LDL cholesterol values ( based on measurements in two separate blood sample s drawn 75 and 90 days after infa rct ion ) that exceeded this value were given initial drug therapy according to the four algorithms shown in Table 1 . Patients unable to tolerate bile acid-binding resin or nicotinic acid because of comorbid conditions or potentially adverse interactions with these agents received lovastatin or gemfibrozil . During a visit 90 days after discharge , the nurses did a brief physical examination and obtained a history relevant to hyperlipidemia . They provided detailed counseling to patients regarding the rationale for lipid-lowering drug therapy and ways to maximize drug efficacy and minimize drug side effects , and they advised patients on the schedule of laboratory visits and nurse-initiated follow-up telephone contacts . Table 1 . Initial Drug Therapy * Changes in drug therapy at 120 , 150 , and 180 days , which were coordinated by nurse-initiated telephone contacts , were based on three types of responses to initial therapy : 1 ) if lipoprotein levels returned to normal , the effective drug therapy was continued ; 2 ) if the response was incomplete , the dose of the effective medication was increased or another drug was added , or both ; and 3 ) if comorbid conditions worsened or blood chemistry abnormalities or intolerable side effects occurred , drug dosage was reduced or the patient was switched to another agent or both . A physician lipid specialist and a Stanford-based senior nurse-coordinator provided telephone consultation to the case managers . Before initiating lipid-lowering drug therapy at 90 days and at each subsequent step , nurses review ed the patients ' blood chemistry and lipoprotein values and elicited any symptoms requiring a change in therapy . The OBJECTIVES This study evaluated a nurse-managed smoking cessation program for smokers hospitalized for a variety of conditions . METHODS Hospitalized patients who smoked prior to hospitalization and who were motivated to quit ( n = 660 ) were r and omized to intervention or usual-care groups and followed for the next year . The intervention included a meeting with the nurse-case manager ; the use of a videotape , workbook , relaxation audiotape , and nicotine replacement therapy ; and nurse-initiated phone contacts after discharge . RESULTS The 12-month confirmed cessation rates were 21 % and 31 % for , respectively , the usual-care and intervention groups ( odds ratio = 1.7 ; 95 % confidence interval = 1.1 , 2.3 ) . CONCLUSIONS A nurse-managed smoking cessation intervention can significantly increase cessation rates for hospitalized patients The present study aim ed to determine whether tobacco use cessation rates observed in controlled trials of a hospital-based tobacco use cessation program could be replicated when the program was disseminated to a wide range of hospitals in a two-stage process including implementation and institutionalization phases . Using a nonr and omized , observational design , we recruited six hospitals to participate in the study . The research team helped implement the program during the first year of participation ( implementation ) and then withdrew from active involvement during the second year ( institutionalization ) . The mean 6-month self-reported cessation rates were 26.3 % ( range = 17.6%-52.8 % ) for the implementation phase and 22.7 % ( range = 12.9%-48.2 % ) for the institutionalization phase . Hospitals with paid professionals providing the program had the best outcomes . Inpatient tobacco use cessation programs are feasible to implement and should target a 6-month self-reported cessation rate of at least 25 % STUDY OBJECTIVE To determine the effect of a nurse-managed intervention for smoking cessation in patients who have had a myocardial infa rct ion . DESIGN R and omized , with a 6-month treatment period and a 6-month follow-up . SETTING Kaiser Foundation hospitals in Redwood City , Santa Clara , Hayward , and San Jose , California . PATIENTS Sequential sample of 173 patients , 70 years of age or younger , who were smoking before hospitalization for acute myocardial infa rct ion . Eighty-six patients were r and omly assigned to the intervention and 87 to usual care ; 130 patients ( 75 % ) completed the study and were available for follow-up . INTERVENTION Nurse-managed and focused on preventing relapse to smoking , the intervention was initiated in the hospital and maintained thereafter primarily through telephone contact . Patients were given an 18-page manual that emphasized how to identify and cope with high-risk situations for smoking relapse . MEASUREMENTS AND MAIN RESULTS One year after myocardial infa rct ion , the smoking cessation rate , verified biochemically , was 71 % in the intervention group compared with 45 % in the usual care group , a 26 % difference ( 95 % CI , 9.5 % to 42.6 % ) . Assuming that all surviving patients lost to follow-up were smoking , the 12-month smoking cessation rate was 61 % in the intervention group compared with 32 % in the usual care group , a 29 % difference ( 95 % CI , 14.5 % to 43.5 % ) . Patients who either resumed smoking within 3 weeks after infa rct ion or expressed little intention of stopping in the hospital were unlikely to have stopped by 12 months . CONCLUSIONS A nurse-managed smoking cessation intervention largely conducted by telephone , initiated in the hospital , and focused on relapse prevention can significantly reduce smoking rates at 12 months in patients who have had a myocardial infa rct ion PURPOSE To determine whether an intensive cognitive-behavioral intervention begun during hospitalization when combined with transdermal nicotine replacement therapy is more effective than a minimal counseling intervention combined with transdermal nicotine replacement therapy in helping in patients to quit smoking . METHODS A total of 223 patients who smoked were enrolled in a hospital-based r and omized smoking cessation trial at the San Francisco Veterans Affairs Medical Center . One hundred and seven participants ( 48 % ) received intensive counseling and outpatient telephone follow-up ; 116 participants ( 52 % ) received minimal counseling . All study participants received 2 months of transdermal nicotine replacement therapy . We determined 6-month quit rates by self-report and measured saliva cotinine levels or obtained proxy reports to confirm self-reported smoking cessation at 12 months . Analyses adjusted for baseline differences in the distribution of coronary disease . RESULTS At 6 months , 35 % ( 36/103 ) of the intensive intervention group reported quitting , compared with 21 % ( 23/109 ) of the comparison group ( relative risk [ RR ] = 1.7 ; 95 % confidence interval [ CI ] : 1.1 to 2.7 ) . At 12 months , the self-reported quit rate was 33 % ( 33/99 ) in the intensive intervention group versus 20 % ( 21/103 ) in the comparison group ( RR = 1.7 ; 95 % CI : 1.1 to 2.7 ) . Based on biochemical or proxy confirmation , 29 % ( 30/102 ) in the intensive intervention group versus 20 % ( 21/107 ) in the comparison group quit smoking at 12 months ( RR = 1.6 ; 95 % CI : 0.96 to 2.5 ) . CONCLUSION Hospital-initiated smoking cessation interventions that include transdermal nicotine replacement therapy can improve long-term quit rates We tested an intervention to help smokers abstain ( fast ) from smoking before surgery , maintain abstinence postoperatively , and achieve long-term cessation . A r and omized experiment included 237 patients admitted for presurgical assessment who smoked . The intervention included counseling and nicotine replacement therapy . Treatment group participants ( 73.0 % ) were more likely to fast than were controls ( 53.0 % ) : chi(2)(1 , N = 228 ) = 8.89 , p = .003 , and more likely to be abstinent 6 months after surgery ( 31.2 % vs. 20.2 % ) . There was no significant difference in the abstinence rates at 12 months after surgery , chi(2)(1 , N = 169 ) < .001 , p = 1.00 . Encouraging patients to fast from smoking before surgery and postoperative support are efficacious ways to reduce preoperative and immediate post-operative tobacco use Introduction : Chronic obstructive pulmonary disease ( COPD ) is a major contributor to morbidity and mortality . Smoking is the leading cause of COPD . Results from r and omised trials regarding smoking cessation in hospitalised patients with COPD are few Health care increasingly incorporates telephone counseling , but the interactions supporting its delivery are not well understood . The authors ’ clinical trial of a tailored , nurse-administered smoking cessation intervention for surgical patients included a telephone counseling component and provided an opportunity to describe the interaction dynamics of proactive telephone counseling over the course of 4 months . Tape-recorded telephone counseling calls for 56 consecutively enrolled individuals r and omized to the intervention group result ed in a data set of 368 calls , which were transcribed and analyzed using constant comparative methods . The findings revealed varying interaction dynamics depending on the nurse ’s level of engagement with participants and participants ’ motivation to stop smoking . The authors identified four interaction dynamics : affirming/working , chasing/skirting , controlling/withdrawing , and avoiding commitment . Shifts in interaction dynamics were common and influenced the provision of support both positively and negatively . The findings challenge many assumptions underlying telephone counseling and suggest strategies to improve its delivery OBJECTIVES This study evaluated the cost-effectiveness of a smoking cessation and relapse-prevention program for hospitalized adult smokers from the perspective of an implementing hospital . It is an economic analysis of a two-group , controlled clinical trial in two acute care hospitals owned by a large group-model health maintenance organization . The intervention included a 20-minute bedside counseling session with an experienced health counselor , a 12-minute video , self-help material s , and one or two follow-up calls . METHODS Outcome measures were incremental cost ( above usual care ) per quit attributable to the intervention and incremental cost per discounted life-year saved attributable to the intervention . RESULTS Cost of the research intervention was $ 159 per smoker , and incremental cost per incremental quit was $ 3,697 . Incremental cost per incremental discounted life-year saved ranged between $ 1,691 and $ 7,444 , much less than most other routine medical procedures . Replication scenarios suggest that , with realistic implementation assumptions , total intervention costs would decline significantly and incremental cost per incremental discounted life-year saved would be reduced by more than 90 % , to approximately $ 380 . CONCLUSIONS Providing brief smoking cessation advice to hospitalized smokers is relatively inexpensive , cost-effective , and should become a part of the st and ard of inpatient care BACKGROUND AND AIMS Rehabilitation centres for mothers are a suitable setting to offer smoking cessation treatment to these women . Telephone aftercare could enhance the effectiveness of an inpatient smoking cessation program . We investigated whether non-directive , supportive aftercare or a structured , smoking specific counselling give more benefit . PATIENTS AND METHOD 527 smoking mothers participated in a smoking cessation program during their stay in a prevention/rehabilitation centre . Afterwards they were r and omly assigned to one of three aftercare conditions : no aftercare ( control group ) , structured telephone aftercare or non-directive telephone aftercare . At the end of the inpatient program and 6 months later the smoking status of the participants was assessed . RESULTS The structured telephone aftercare result ed in the highest abstinence rates after 6 months ( 31.5 % ; odds ratio 2.0 ; confidence interval : 1.1 - 3.8 ) . The non-directive telephone counselling had no significant effect on abstinence rates . CONCLUSIONS A structured telephone aftercare proves to be an effective intervention for women , which stabilizes the abstinence rate following a clinic based smoking cessation program This study evaluated the impact of a nurse-led health education programme on the behaviour , nicotine dependence and nicotine withdrawal in patients who smoke and suffer from peripheral vascular disease , based in a large teaching hospital in the north of Engl and . Smoking behaviour was measured by self report , end-expired carbon monoxide and urinary cotinine . Nicotine dependence and withdrawal were measured using a nicotine dependence scale and a nicotine withdrawal scale . The findings demonstrated that the programme did have some impact on behaviour . The study raised issues concerning the measurement of physiological markers for smoking as nursing outcomes . Issues about the measurement of nicotine dependence and withdrawal are highlighted PURPOSE Patients who continue to smoke following coronary artery bypass graft surgery ( CABG ) have substantially poorer outcomes than patients able to stop smoking after CABG . This study evaluated the effectiveness of two smoking cessation treatment strategies in patients undergoing CABG . METHODS Two smoking cessation treatment strategies were compared in smokers who underwent CABG . In the conservative treatment strategy , smokers undergoing CABG were followed up prospect ively at monthly intervals . Patients who started smoking again at any time in the year following CABG were asked to enroll in an 8-week smoking cessation program . In the aggressive treatment strategy , smokers undergoing CABG were asked to enroll in an 8-week smoking cessation program starting immediately after hospital discharge . The structure and makeup of the smoking cessation program used in the conservative and aggressive treatment strategies were identical . The primary study outcome was smoking status assessed by self-report and confirmed by expired carbon monoxide at 1.5 months , 3 months , 6 months , and 12 months after surgery . RESULTS Nineteen patients were enrolled in the conservative treatment strategy , with 2 patients unavailable for follow-up prior to the first follow-up visit . Of the remaining 17 patients , 14 patients ( 82 % ) resumed smoking at an average of 10.3 weeks after CABG . Eleven of these 14 patients ( 79 % ) agreed to participate in the smoking cessation program . Based on evaluable patients , 10 of the 17 patients ( 59 % ) in the conservative strategy group were not smoking at the 12-month follow-up . Twenty patients were enrolled in the aggressive treatment strategy . All patients agreed to participate in the smoking cessation program . All patients were available for follow-up . At the 12-month follow-up , 17 of 29 patients ( 85 % ) in this treatment strategy were not smoking . Point prevalence and continuous abstinence cessation rates were significantly greater in the aggressive treatment strategy compared to the conservative treatment strategy at all follow-up intervals after CABG . CONCLUSION Based on our findings in a small number of patients , an aggressive smoking cessation intervention is associated with a superior smoking cessation rate compared to a conservative treatment strategy in smokers undergoing CABG . A larger study will be needed to confirm that an early aggressive smoking cessation intervention should be provided to all smokers undergoing CABG OBJECTIVE To evaluate the effectiveness of a nurse led shared care programme to improve coronary heart disease risk factor levels and general health status and to reduce anxiety and depression in patients awaiting coronary artery bypass grafting ( CABG ) . DESIGN R and omised controlled trial . SETTING Community , January 1997 to March 1998 . STUDY GROUPS 98 ( 75 male ) consecutive patients were recruited to the study within one month of joining the waiting list for elective CABG at Glasgow Royal Infirmary University NHS Trust . Patients were r and omly assigned to usual care ( control ; n = 49 ) or a nurse led intervention programme ( n = 49 ) . INTERVENTION A shared care programme consisting of health education and motivational interviews , according to individual need , was carried out monthly . Care was provided in the patients ' own homes by the community based cardiac liaison nurse alternating with the general practice nurse at the practice clinic . OUTCOME MEASURES Smoking status , obesity , physical activity , anxiety and depression , general health status , and proportion of patients exceeding target values for blood pressure , plasma cholesterol , and alcohol intake . RESULTS Compared with patients who received usual care , those participating in the nurse led programme were more likely to stop smoking ( 25 % v 2 % , p = 0.001 ) and to reduce obesity ( body mass index > 30 kg/m2 ) ( 16.3 % v 8.1 % , p = 0.01 ) . Target systolic blood pressure improved by 19.8 % compared with a 10.7 % decrease in the control group ( p = 0.001 ) and target diastolic blood pressure improved by 21.5 % compared with 10.2 % in the control group ( p = 0.000 ) . However , there was no significant difference between groups in the proportion of patients with cholesterol concentrations exceeding target values . There was a significant improvement in general health status scores across all eight domains of the 36 item short form health survey with changes in difference in mean scores between the groups ranging from 8.1 ( p = 0.005 ) to 36.1 ( p < 0.000 ) . Levels of anxiety and depression improved ( p < 0.000 ) and there was improvement in time spent being physically active ( p < 0.000 ) . CONCLUSIONS This nurse led shared care intervention was shown to be effective for improving care for patients on the waiting list for CABG This study tested the feasibility and efficacy of a brief smoking intervention for adolescents in a hospital setting . Forty adolescent patients were r and omized to receive either brief advice or a motivational interview , a nonconfrontational therapeutic intervention . Feasibility of brief smoking interventions with teen patients was supported by high rates of recruitment , retention , and quit attempts , and long periods of continuous abstinence . Although between-groups differences on smoking measures were not significant at 3-month follow-up , an effect size of h = .28 was noted . The sample showed significant decreases in smoking dependence and number of days smoked . Baseline stage of change , smoking rate , and depression were significant prospect i ve predictors of smoking outcome . Implication s for smoking intervention research with adolescents are discussed This study was conducted to evaluate the effect of a teaching program on patients with myocardial infa rct ion . Forty-five patients were r and omly selected 22 were assigned to a teaching group and 23 to a control group . An individualized teaching program was delivered to the teaching group during the hospitalization period . It covered aspects such as : the characteristics of heart disease , the anatomy and physiology of the heart , risk factors of atherosclerosis , medication and diet and exercise therapy . When these subjects were discharged to their homes , they received regular supportive care via telephone or mail for 12 weeks . Atherosclerotic risk factors , including , smoking , exercise , blood lipid profile and BMI were measured before and after the teaching program . Post-testing revealed that the numbers of those who exercised and the number of non-smokers were significantly higher in the teaching group than in the control group . Increased HDL cholesterol ( High-Density Lipoprotein cholesterol ) was significantly greater in the teaching group than in the control group . The above findings suggest that this individualized teaching program might be helpful at reducing the risk factors of atherosclerosis in myocardial infa rct ion patients BACKGROUND Smoking cessation after myocardial infa rct ion ( MI ) has been associated with a 50 % reduction in mortality but in-hospital smoking cessation interventions are rarely part of routine clinical practice . METHODS One hundred cigarette smokers consecutively admitted during 1996 with MI were assigned to minimal care or to a hospital-based smoking cessation program . Intervention consisted of bedside cessation counseling followed by seven telephone calls over the 6 months following discharge . Primary outcomes were abstinence rates measured at 6 months and 1 year post-discharge . RESULTS At follow-up , 43 and 34 % of participants in minimal care and 67 and 55 % of participants in intervention were abstinent at 6 and 12 months . respectively ( P<0.05 ) . Abstinence rates were calculated assuming that participants lost to attrition were smokers at follow-up . Intervention and self-efficacy were independent predictors of smoking status at follow-up . Low self-efficacy combined with no intervention result ed in a 93 % relapse rate by 1 year ( P<0.01 ) . CONCLUSIONS A hospital-based smoking cessation program consisting of inpatient counseling and telephone follow-up substantially increases smoking abstinence 1 year after discharge in patients post-MI . Patients with low self-efficacy are almost certain to relapse without intervention . Such smoking cessation programs should be part of the management of patients with MI OBJECTIVE A pilot study was conducted to determine the feasibility and potential efficacy of an interactive voice response ( IVR ) follow-up system for smokers recently hospitalized with coronary heart disease ( CHD ) . METHODS Ninety-nine smokers hospitalized with CHD completed a baseline question naire , were provided with bedside counseling , and offered nicotine replacement therapy . They were r and omly assigned to a usual care ( UC ) or an IVR group . The IVR group received automated telephone follow-up calls 3 , 14 and 30 days after discharge inquiring about their smoking status and confidence in remaining smoke-free . When deemed necessary , they were offered additional counseling . Smoking status was determined 52 weeks after hospital discharge . RESULTS The 52-week point prevalence abstinence rate in the IVR group was 46.0 % compared to 34.7 % in the UC group ( OR=1.60 , 95 % CI : 0.71 - 3.60 ; P=.25 ) . After adjustment for education , age , reason for hospitalization , length of hospitalization , and quit attempts in the past year , the odds of quitting in the IVR group compared to the UC group were 2.34 ( 95 % CI : 0.92 - 5.92 ; P=.07 ) . CONCLUSIONS IVR is a promising technology for following CHD patients attempting to quit smoking following discharge from hospital , however , a larger trial is required to confirm its efficacy . PRACTICE IMPLICATION S IVR may enhance the timely provision of follow-up counseling for smoking cessation in patients with CHD Objective . To evaluate whether smoking cessation after a coronary event improves quality of life , and to assess whether quality of life is a predictor of smoking cessation . Design . Health-related quality of life at baseline and at 12 months follow up were measured in a r and omised smoking cessation trial of 240 smokers aged under 76 years admitted for myocardial infa rct ion , unstable angina or coronary bypass surgery . At 12 months follow up 101 had managed to give up smoking ( quitters ) , and 117 were smokers ( sustained smokers ) . Results . The quitters and sustained smokers had similar improvements in all quality of life domains from baseline to 12 months follow up . Further , after adjustment for differences in baseline characteristics , the quality of life was not significantly different in the quitters compared to the sustained smokers neither at baseline nor at 12 months follow up . Conclusions . Smoking cessation did not improve quality of life compared to sustained smoking after a coronary event in a 12 month follow up . Quality of life was not a significant predictor of smoking cessation OBJECTIVE To determine the predictors of continued smoking abstinence in patients receiving smoking cessation intervention during and following hospital admission . METHODOLOGY A prospect i ve cohort study was conducted in a university-affiliated hospital . A total of 248 smokers admitted with primary cardiac and respiratory conditions received verbal advice ( lasting about 1 h ) and st and ard booklets on smoking cessation from a dedicated nurse counsellor . After discharge , participants received follow-up telephone counselling calls every 2 weeks from the same smoking counsellor . The main outcome measure was continued abstinence at 2 months after hospital discharge , as determined by self-reporting and carbon monoxide breath testing . The following groups of covariates were analysed to determine the possible factors associated with smoking abstinence : demographics , smoking history , readiness to quit , and medical history . RESULTS At 2 months post-discharge , 108 ( 43.5 % ) patients remained abstinent . Low nicotine dependence score ( odds ratio , 2.30 ; 95 % CI , 1.25 - 4.26 ; P = 0.008 ) , decision to quit by sudden cessation as compared to reduction of smoking ( odds ratio , 7.19 ; 95 % CI , 1.56 - 33.06 ; P = 0.011 ) , and initial hospitalization for their medical condition ( odds ratio , 6.37 ; 95 % CI , 1.33 - 30.44 ; P = 0.020 ) were the main independent predictors for positive outcome . CONCLUSION Among this cohort of hospitalized patients receiving smoking cessation intervention , low dependence on tobacco , motivation to quit by sudden cessation , and initial hospitalization were the main independent predictors of smoking abstinence after discharge from hospital BACKGROUND Tobacco cessation after acute myocardial infa rct ion ( AMI ) substantially improves outcome but how effective individual programmes are needs to be established . To date , few studies have examined this factor . AIMS To assess the outcome of two smoking cessation programmes after AMI . METHODS One hundred and ninety-eight current smokers admitted to coronary care with an AMI participated in a r and omized controlled study comparing two outpatient tobacco interventions , the Stanford Heart Attack Staying Free ( SF ) programme and a Usual Care ( UC ) programme . RESULTS Log-rank analyses revealed that patients in the SF programme were retained longer ( P < 0.001 ) and had higher cotinine vali date d abstinence rates ( P < 0.001 ) compared with patients in the UC programme . Twelve months after intervention , 39 % of the SF programme compared with 2 % of the UC programme demonstrated cotinine vali date d tobacco cessation , representing a significant reduced relapse rate in the SF programme ( chi2 , P < 0.001 ) . CONCLUSIONS The SF smoking cessation programme initiated in hospital can significantly reduce smoking rates at 12 months after myocardial infa rct ion . Although superior to the UC quit programme , Australian outcomes were lower than the American programme originators ' published outcomes Background Smoking cessation is probably the most important action to reduce mortality after a coronary event . Smoking cessation programs are not widely implemented in patients with coronary heart disease , however , possibly because they are thought not to be worth their costs . Our objectives were to estimate the cost effectiveness of a smoking cessation program , and to compare it with other treatment modalities in cardiovascular medicine . Methods A cost-effectiveness analysis was performed on the basis of a recently conducted r and omized smoking cessation intervention trial in patients admitted for coronary heart disease . The cost per life year gained by the smoking cessation program was derived from the re sources necessary to implement the program , the number needed to treat to get one additional quitter from the program , and the years of life gained if quitting smoking . The cost effectiveness was estimated in a low-risk group ( i.e. patients with stable coronary heart disease ) and a high-risk group ( i.e. patients after myocardial infa rct ion or unstable angina ) , using survival data from previously published investigations , and with life-time extrapolation of the survival curves by survival function modeling . Results In a lifetime perspective , the incremental cost per year of life gained by the smoking cessation program was ∊280 and ∊110 in the low and high-risk group , respectively ( 2000 prices ) . These costs compare favorably to other treatment modalities in patients with coronary heart disease , being approximately 1/25 the cost of both statins in the low-risk group and angiotensin-converting enzyme inhibitors in the high-risk group . In a sensitivity analysis , the costs remained low in a wide range of assumptions . Conclusions A nurse-led smoking cessation program with several months of intervention is very cost-effective compared with other treatment modalities in patients with coronary heart disease PURPOSE S To compare an intensive smoking cessation intervention against usual care in hospitalized high-risk smokers with acute cardiovascular disease . METHODS A total of 209 hospitalized smokers were r and omized to the intensive intervention ( n = 109 ) or to usual care ( n = 100 ) . Usual care consisted only of counseling and printed educational material provided prior to hospital discharge . Intensive treatment consisted of a minimum of 12 weeks of behavior modification counseling and individualized pharmacotherapy provided at no cost to the participant . Smoking status in all subjects was confirmed biochemically ( ie , by measuring expired carbon monoxide ) at 3 , 6 , 12 , and 24 months after r and omization . Outcomes included point prevalence and continuous abstinence smoking cessation rates , hospitalizations , and all-cause mortality . RESULTS At each follow-up interval , point prevalence and continuous abstinence smoking cessation rates were significantly greater in the intensive-treatment group compared to the usual-care group . At 24 months , continuous abstinence smoking cessation rates were 33 % in the intensive-treatment group and 9 % in the usual-care group ( p < 0.0001 ) . Over the 2-year follow-up period , 41 patients in the usual-care group were hospitalized compared to 25 patients in the intensive-treatment group ( relative risk reduction [ RRR ] , 44 % ; 95 % confidence interval [ CI ] , 16 to 63 % ; p = 0.007 ) . The all-cause mortality rate was 2.8 % in the intensive-treatment group and 12.0 % in the usual-care group ( RRR , 77 % ; 95 % CI , 27 to 93 % ; p = 0.014 ) . The absolute risk reduction in mortality was 9.2 % with a number needed to treat of 11 . CONCLUSION Hospitalized smokers , especially those with cardiovascular disease , should undergo treatment with a structured intensive cessation intervention . The duration of the initial treatment should be 3 months abstract Objective To determine whether a nurse led smoking cessation intervention affects smoking cessation rates in patients admitted for coronary heart disease . Design R and omised controlled trial . Setting Cardiac ward of a general hospital , Norway . Participants 240 smokers aged under 76 years admitted for myocardial infa rct ion , unstable angina , or cardiac bypass surgery . 118 were r and omly assigned to the intervention and 122 to usual care ( control group ) . Intervention The intervention was based on a booklet and focused on fear arousal and prevention of relapses . The intervention was delivered by cardiac nurses without special training . The intervention was initiated in hospital , and the participants were contacted regularly for at least five months . Main outcome measure Smoking cessation rates at 12 months determined by self report and biochemical verification . Results 12 months after admission to hospital , 57 % ( n = 57/100)of patients in the intervention group and 37 % ( n = 44/118 ) in the control group had quit smoking ( absolute risk reduction 20 % , 95 % confidence interval 6 % to 33 % ) . The number needed to treat to get one additional person who would quit was 5 ( 3 to 16 ) . Assuming all dropouts relapsed at 12 months , the smoking cessation rates were 50 % in the intervention group and 37 % in the control group ( absolute risk reduction 13 % , 0 % to 26 % ) . Conclusion A smoking cessation programme delivered by cardiac nurses without special training , significantly reduced smoking rates in patients 12 months after admission to hospital for coronary heart disease Background : Programs for smoking cessation for cardiac patients are underused in Canada . We examined the efficacy of an intervention for smoking cessation for patients admitted to hospital for coronary artery bypass graft ( CABG ) or because of acute myocardial infa rct ion ( MI ) . Methods : Nurses r and omly assigned 276 sequential patients admitted because of acute MI or for CABG who met the inclusion criteria . Participants received an intensive or minimal smoking-cessation intervention . The minimal intervention included advice from physicians and nurses and 2 pamphlets . The intensive intervention included the minimal intervention plus 60 minutes of bedside counselling , take-home material s and 7 nurse-initiated counselling calls for 2 months after discharge . The outcomes were point prevalence of abstinence at 3 , 6 and 12 months after discharge . Results : The 12-month self-reported rate of abstinence was 62 % among patients in the intensive group and 46 % among those in the minimal group ( odds ratio [ OR ] 2.0 , 95 % confidence interval [ CI ] 1.2–3.1 ) . Abstinence was confirmed for 54 % of patients in the intensive group and 35 % in the minimal group ( OR 2.0 , 95 % CI 1.3–3.6 ) . Abstinence was significantly lower among those who used pharmacotherapy than among those who did not ( p < 0.001 ) . Continuous 12-month abstinence was 57 % in the intensive group and 39 % in the minimal group ( p < 0.01 ) . It was significantly higher among patients admitted for CABG than among those admitted because of acute MI ( p < 0.05 ) . Interpretation : Providing intensive programs for smoking cessation for patients admitted for CABG or because of acute MI could have a major impact on health and health care costs This gender-specific research study compares the relative effectiveness of two theory-based interventions targeting women who smoke . Women with coronary artery disease ( CAD ; n = 53 ) or CAD risk factors ( n = 107 ) were r and omly assigned to either coping-skills Relapse Prevention ( RP ) treatment or an educational/supportive treatment based on Health Belief Model ( HBM ) principles . RP was comparable , but not superior to HBM treatment , as indicated by the lack of differential smoking outcomes at 3 and 6 months . RP was more effective than HBM for women with low self-efficacy , as predicted . The presence of a smoking-related disease had a substantial effect on smoking status , in that the odds of being abstinent at 6 months were 2.2 times greater for non-diagnosed women when compared with CAD women . These findings indicate that more potent relapse prevention interventions are needed to increase cessation rates in women who smoke , especially those with established heart disease OBJECTIVES The objective was to analyse whether a favourable change in risk factors , caused by a comprehensive risk factor modification programme , affected intima-media thickness ( IMT ) in the common carotid artery , and whether any such change was associated with a change in cardiovascular events during a 6-year follow-up . DESIGN Patients were r and omized 1 : 1 to special intervention or usual care . SETTING Hypertension Unit at university hospital . SUBJECTS A total of 164 patients were r and omized . Inclusion criteria were male , aged 50 - 72 years ( at r and omization ) and one or more of the following : Serum cholesterol level > 6.5 mmol L(-1 ) , smoking or diabetes mellitus . All patients were prescribed antihypertensive treatment since many years . In 142 men good quality ultrasound recording of the common carotid IMT were achieved at baseline , 119 were re-examined after 3.3 years , and 97 patients were available for examination after mean follow-up time of 6.2 years . Cardiovascular events were available for all r and omized patients . INTERVENTIONS The nonpharmacological special intervention programme was based on one information meeting followed by five weekly 2-h sessions with participation of patients and spouses . The diet recommendations were similar to established guidelines . Overweight patients were instructed to lose weight , and diabetic patients were systematic ally taught self-monitoring of blood glucose . Smokers were invited to a smoking cessation programme with five weekly meetings . Follow-up visits were thereafter scheduled every 6 months . Lipid lowering drugs were recommended in the intervention group if the treatment goals using nonpharmacological measures were not achieved . Patients in the usual care group were told to quit smoking and to lower their consumption of fat and glucose . Antihypertensive treatment ( i.e. , selection of drugs ) was on purpose kept similar in the two groups . MAIN OUTCOME MEASURES The IMT of the common carotid artery as measured by ultrasound . Cardiovascular events during follow-up . RESULTS Significant net reductions were seen for serum cholesterol , triglycerides , fasting glucose and smoking . No difference in change in IMT was observed during follow-up between the two r and omization groups . The explanation was that patients with positive plaque status at baseline had a much larger increase in IMT over time than patients with negative plaque status , and that patients with positive plaque status more often survived and were available for re-examination after 6 years in the intervention group than in the usual care group . Total mortality was lower in the intervention group , compared with the usual care group , 13 and 29 % , respectively ( P=0.028 ) . CONCLUSIONS In high risk population s , long-term studies with surrogate endpoints may be misleading because of missing data in patients where a large increase in IMT would have been observed , had they been re-examined . Another important conclusion from our study was that the gloomy prognosis for this patient category may be improved by a dedicated risk factor intervention programme . The improved prognosis was observed mainly in those patients at highest risk judged from history of cardiovascular disease or positive ultrasound plaque status at baseline Tobacco smoking is a major risk factor for cardiovascular disease [ 1 ] . Smokers who quit reduce their coronary heart disease morbidity and mortality rates , even after the onset of clinical disease . Smokers who quit after a myocardial infa rct ion have lower reinfa rct ion rates and longer survival than do those who continue to smoke [ 2 ] . The relation between smoking and the outcome of coronary artery bypass graft surgery is less well studied , but in one study , smokers who quit after surgery had better survival , fewer attacks of angina , and fewer hospitalizations during a 10-year period [ 3 , 4 ] . Pathologic and angiographic studies show less late saphenous vein graft occlusion in smokers who quit after surgery than in those who do not [ 5 , 6 ] . Neither the pattern nor predictors of smoking cessation after coronary artery bypass graft surgery have been well studied . The operation may induce smoking cessation , because myocardial infa rct ion and newly diagnosed coronary artery disease do so [ 2 , 7 - 9 ] . Approximately one third of smokers quit smoking after having a myocardial infa rct ion [ 2 , 9 , 10 ] . Patients scheduled for coronary bypass surgery , like patients who have myocardial infa rct ion , face a potentially life-threatening event related to coronary heart disease , one requiring hospitalization for at least 1 week . However , coronary bypass surgery is often elective , whereas myocardial infa rct ion may be an unexpected complication of an undiagnosed condition . Consequently , patients may be less motivated to stop smoking after bypass surgery than they are after myocardial infa rct ion . In a r and omized trial of coronary artery bypass surgery , 25 % of smokers assigned to surgery stopped smoking in the year after the operation , and smoking rates remained constant for the next 5 years [ 11 ] . Two newer studies reported higher cessation rates ( 31 % and 55 % ) [ 12 , 13 ] . None of these studies vali date d self-reported smoking status at follow-up or identified factors associated with nonsmoking . Even less is known about the success of smoking interventions in patients having coronary bypass surgery . In-hospital intervention boosts the cessation rate after myocardial infa rct ion [ 10 , 14 ] , but whether it will do so after bypass surgery is unknown . To determine this , we developed a smoking cessation program for in patients recovering from coronary artery bypass surgery and tested its effectiveness in a r and omized , controlled trial . We chose this approach because patients who undergo coronary bypass surgery spend a median of 11 days in the hospital after surgery [ 15 ] . During this time , they are not permitted to smoke , can be easily reached by an intervention team , and may be highly motivated to quit . We reasoned that we could take advantage of this period of enforced nonsmoking to teach smokers the skills to remain abstinent after discharge . We also tried to identify factors associated with sustained nonsmoking to guide future intervention efforts . Methods Recruitment and R and omization This trial was conducted in the postoperative cardiac surgery unit at Massachusetts General Hospital . During 1 year ending 1 July 1987 , we review ed the charts of all 672 patients scheduled for coronary artery bypass surgery by six participating surgeons ( 82 % of all such procedures ) . A research nurse recruited patients who met eligibility criteria : those who had smoked at least 1 pack of cigarettes in the past 6 months , lived in eastern Massachusetts or Rhode Isl and , spoke English , and were not too ill to participate . We included both current smokers and recent ( < 6 months ) quitters because of the high relapse rates known to follow smoking cessation . Of 672 patients scheduled for the surgery , 152 ( 23 % ) were current smokers or had quit within 6 months . Of 120 patients meeting eligibility criteria , 93 ( 78 % ) agreed to participate . Reasons for refusals were insufficient time to collect baseline data ( n = 8) , too much stress ( n = 6 ) , no desire to quit ( n = 6 ) , or perceived ability to quit without assistance ( n = 3 ) . Patients were r and omly assigned to control or intervention groups after surgery . Intervention began when the patient was physically able to participate , generally on the fourth day after operation . Four participants were lost before r and omization ( surgery was canceled for 3 and 1 died ) , and 89 patients were r and omly assigned to control or intervention groups . Two patients , one in each group , died before discharge , when outcome was first assessed . This report is based on the 87 patients ( 43 controls , 44 patients receiving the intervention ) who were discharged alive . Intervention The intervention was a smoking cessation and relapse prevention program adapted from the American Lung Association 's In Control program , which teaches cognitive and behavioral smoking cessation techniques [ 16 ] . We used edited portions of the videotape and manual to produce a st and ardized , three-session program delivered by the study nurse to individual patients . Family members were encouraged to attend . Total counseling time was 60 minutes . One week after discharge , the nurse called each participant to offer support and brief counseling . Patients in the control group received usual postoperative care , including brief advice not to smoke as part of a group lecture . In patients were not permitted to smoke by hospital policy . Assessment Patients completed a baseline data form before surgery . It assessed demographic factors ( age , sex , ethnic background , education , and employment status ) , functional status [ 17 ] , smoking history ( pack-years and daily cigarette consumption ) , degree of nicotine addiction [ 18 ] , current symptoms of nicotine withdrawal [ 19 ] , previous attempts to quit smoking ( number of attempts , duration , difficulty , and method ) , level of social support for nonsmoking , percentage of household members and friends who smoke , knowledge and attitudes about smoking and heart disease ( 15 items ) , duration of nonsmoking before surgery , intention to quit after surgery , and confidence in their ability to quit . Charts were review ed for medical history , severity of heart disease ( frequency of angina attacks , number of myocardial infa rct ions , previous bypass surgery or angioplasty , left ventricular function on angiogram , and number of coronary vessels occluded and bypassed ) , and hospital course ( length of stay and occurrence of 12 complications ) . The primary outcome variable was smoking behavior , assessed by self-report and vali date d by saliva cotinine assay [ 20 ] . Smoking status was monitored at hospital discharge and 2 weeks and 2 , 4 , 8 , and 12 months later . It was also assessed in September 1992 , a median of 5.5 years after discharge ( range , 60 to 72 months ) . At 1 and 5.5 years , self-reported nonsmoking was vali date d by saliva cotinine assay [ 20 ] . Sample s were obtained by mail , a method previously shown to accurately identify smokers and nonsmokers [ 21 ] . Individuals who did not provide saliva sample s or whose cotinine concentrations were more than 20 ng/mL were considered smokers [ 22 ] . Death certificate data were review ed to identify patients lost to follow-up . Eighty patients ( 92 % ) were alive 1 year after discharge , and smoking status was determined in all of them . Seventy patients ( 80 % ) were alive at 5.5 years , and smoking status was assessed in 66 ( 94 % ) . More than 90 % of follow-up information was obtained by telephone . If this was not possible , patients were sent a written form . Other variables assessed at follow-up were nicotine withdrawal symptoms , attitudes and beliefs about smoking , confidence in the ability to quit , health status , and functional status . We also monitored co interventions , including attendance at a cardiac rehabilitation or smoking cessation program , interim hospitalization , and use of nicotine gum . ( Transdermal nicotine was not available during the study period . ) Data Analysis Two outcome rates were calculated : continuous nonsmoking ( no smoking since hospital discharge ) and current nonsmoking ( no smoking for the past week ) [ 23 ] . Following st and ard practice , patients lost to follow-up and patients whose reports of nonsmoking were not vali date d biochemically were counted as smokers when calculating cessation rates [ 23 ] . We excluded these patients and repeated the calculations . To identify factors associated with smoking cessation , we compared smokers and nonsmokers 1 and 5.5 years after surgery . To minimize misclassification of smoking status in these analyses , we excluded patients lost to follow-up and nonsmokers whose self-report was not vali date d biochemically . We compared differences in proportions and means between groups using chi-square tests and Student t-tests , respectively . Variables associated with nonsmoking at the P < 0.05 level were entered into backward stepwise , multiple logistic regression models , and odds ratios with 95 % CIs were calculated . Age , sex , and education level were included in all multivariate models . Significance tests were two-tailed . Results Comparison of Groups at Baseline No statistically significant differences were found between control and intervention groups at study entry or during hospitalization ( Table 3 ) . The typical participant was a middle-aged , white man with a high school education who smoked 1.5 packs each day and had a 58 pack-year smoking history . Participants had made an average of 2.5 attempts to quit smoking , but only 14 % had attended a formal program . Although 79 % of patients had been told to abstain from cigarettes before surgery , 48 % smoked in the week before admission and 15 % smoked in the hospital before surgery . In contrast , 38 % abstained from tobacco for more than 1 month before admission and 19 % did not smoke for more than 3 months . As a group , participants knew that smoking contributed to their heart disease and believed that they would benefit from quitting . They were strongly motivated to quit smoking after surgery and expected some difficulty but were confident of success . They felt strong social support for Long-term beta blockade for perhaps a year or so following discharge after an MI is now of proven value , and for many such patients mortality reductions of about 25 % can be achieved . No important differences are clearly apparent among the benefits of different beta blockers , although some are more convenient than others ( or have slightly fewer side effects ) , and it appears that those with appreciable intrinsic sympathomimetic activity may confer less benefit . If monitored , the side effects of long-term therapy are not a major problem , as when they occur they are easily reversible by changing the beta blocker or by discontinuation of treatment . By contrast , although very early IV short-term beta blockade can definitely limit infa rct size , more reliable information about the effects of such treatment on mortality will not be available until a large trial ( ISIS ) reports later this year , with data on some thous and s of patients entered within less than 4 hours of the onset of pain . Our aim has been not only to review the 65-odd r and omized beta blocker trials but also to demonstrate that when many r and omized trials have all applied one general approach to treatment , it is often not appropriate to base inference on individual trial results . Although there will usually be important differences from one trial to another ( in eligibility , treatment , end-point assessment , and so on ) , physicians who wish to decide whether to adopt a particular treatment policy should try to make their decision in the light of an overview of all these related r and omized trials and not just a few particular trial results . Although most trials are too small to be individually reliable , this defect of size may be rectified by an overview of many trials , as long as appropriate statistical methods are used . Fortunately , robust statistical methods exist -- based on direct , unweighted summation of one O-E value from each trial -- that are simple for physicians to use and underst and yet provide full statistical sensitivity . These methods allow combination of information from different trials while avoiding the unjustified direct comparison of patients in one trial with patients in another . ( Moreover , they can be extended of such data that there is no real need for the introduction of any more complex statistical methods that might be more difficult for physicians to trust . ) Their robustness , sensitivity , and avoidance of unnecessary complexity make these particular methods an important tool in trial overviews BACKGROUND Cigarette smoking is the greatest cause of preventable mortality in the United States . Because most smokers would like to quit and most hospitals are smoke free , surgical admissions represent a window of opportunity for tobacco cessation interventions . METHODS A total of 324 patients ( 98 % men ) , aged 25 to 82 years , who were current smokers and who underwent noncardiac surgery were enrolled in a r and omized controlled trial at the Veterans Affairs Medical Center , San Francisco , Calif. One hundred sixty-eight participants ( 52 % ) received a multicomponent intervention design ed to increase self-efficacy and coping skills that included face-to-face in-hospital counseling , viewing a smoking cessation videotape , self-help literature , nicotine replacement therapy , and 3 months of telephone follow-up . One hundred fifty-six participants ( 48 % ) received self-help literature and brief counseling lasting 10 minutes . Serum or saliva cotinine levels were measured to confirm self-reported smoking cessation . RESULTS At 12 months of follow-up , the self-reported quit rate was 27 % among the intervention group and 13 % among the comparison group ( relative risk , 2.1 ; 95 % confidence interval , 1.2 - 3.5 ; P < .01 ) . Based on biochemical confirmation , 15 % of the intervention group , compared with 8 % of the comparison group , quit smoking at 12 months ( relative risk , 2.0 ; 95 % confidence interval , 1.0 - 3.9 ; P = .04 ) . CONCLUSIONS A smoking cessation intervention targeted at smokers hospitalized for noncardiac surgery can increase long-term quit rates . Surgical hospitalizations provide an opportunity to reach smokers who want to quit smoking PURPOSE We present psychometric properties of 9 health and psychosocial measures in a sample of hospitalized women with cardiovascular disease . This information will be useful to others needing to make choices about selection of health and psychosocial measurements in women smokers . METHODS Psychometric properties were examined using baseline measures from a cross-sectional study , nested within a r and omized clinic trial , Women 's Initiative for Non-Smoking . Women smokers hospitalized with cardiovascular disease were recruited from 10 hospitals in the San Francisco Bay Area . Measures included the perceived stress scale , a depression screener , self-efficacy , the sense of mastery scale , and measures of health-related quality of life from the Medical Outcomes Study . RESULTS The sample of 277 women smokers ranged in age from 34 to 86 years ( mean = 61 + /- 10.1 ) . Studies of variability , including floor/ceiling effects , skewness , range , mean , and SD , indicated that most measures had sufficient variability to be predictive and detect both positive and negative changes over time . Internal-consistency reliabilities ranged from 0.63 to 0.86 . Preliminary evidence of construct validity was found , with most hypotheses being confirmed . CONCLUSIONS The battery of tests included in the Women 's Initiative for Non-Smoking trial may be useful in identifying women at high risk of relapse and in detecting short-term quality -of-life outcomes . The measures generally performed well and show promise for advancing our underst and ing of the process of successful smoking cessation in this population . SUMMARY Psychometric properties of the perceived stress scale , a depression screener , self-efficacy for quitting smoking , the sense of mastery scale , and measures of health-related quality of life from the Medical Outcomes Study in 277 women smokers hospitalized with cardiovascular disease were examined . The measures generally performed well and show promise for advancing our underst and ing of smokers in this population INTRODUCTION Many hospitals advise their smoking patients to contact a community-based stop smoking service . We investigated how well smokers attend a community-based service after receiving help from a hospital smoking cessation specialist ( HSCS ) . METHODS In this 55-week , single-blinded trial , 450 consecutive smokers , attending two U.K. hospitals , were r and omized . Group A received a brief intervention consisting of a 20-min consultation from an HSCS and leaflets with contact information for their community-based service . Group B received a 60-min consultation , four weekly appointments with the HSCS , and leaflets with contact information for their community-based service . Group C received a 60-min consultation and four weekly appointments with the HSCS and then agreed to attend a scheduled appointment at the nearest community-based service within 1 week . Pharmacotherapy was recommended to all participants , and they were advised to attend the community-based service for ongoing support immediately and at Weeks 5 , 12 , 26 , and 52 . At 55 weeks , the HSCS contacted participants again , without warning , for validation . RESULTS Community-based service attendance at 5 weeks was 7 % in Group A , 4 % in Group B , and 23 % in Group C ( p < .001 ) . Over 12 - 26 weeks , rates of community-based service attendance were 6%-12 % in all groups . These rates remained consistently higher in Group C ( p < .05 ) but fell throughout the period to only 3 % , 5 % , and 7 % , respectively , at 52 weeks ( p = .26 ) . HSCS attendance at 55 weeks and point prevalence , vali date d quit rates were 17 % for Group A , 20 % for Group B , and 22 % for Group C ( p = .75 ) . DISCUSSION A specific appointment improves immediate and medium-term attendance at the community-based service , but hospitalized smokers do not switch well to a community-based service following any referral strategy . However , a significant proportion made a repeat visit to the hospital-based program much later on |
1,325 | 29,427,259 | Conclusions Intraoperative cerebral oximetry appears to be associated with a reduction in POCD , although this result should be interpreted with caution given the significant heterogeneity in the studies examined . | Purpose Although evidence from observational studies in a variety of clinical setting s supports the utility of cerebral oximetry as a predictor of outcomes , prospect i ve clinical trials thus far have reported conflicting results .
This systematic review and meta- analysis was design ed to evaluate the influence of management associated with intraoperative cerebral oximetry on postoperative outcomes . | Previous studies showed that decreased cerebral saturation during cardiac surgery is related to adverse postoperative outcome . Therefore , we investigated the influence of intraoperative events on cerebral tissue saturation in patients undergoing cardiac surgery with cardiopulmonary bypass ( CPB ) . A total of 52 adult patients who underwent cardiac surgery using pulsatile CPB were included in this prospect i ve explorative study . Cerebral tissue oxygen saturation ( SctO2 ) was measured in both the left and right cerebral hemisphere . Intraoperative events , involving interventions performed by anesthesiologist , surgeon , and clinical perfusionist , were documented . Simultaneously , in-line hemodynamic parameters ( partial oxygen pressure , partial carbon dioxide pressure , hematocrit , arterial blood pressure , and CPB flow rates ) were recorded . Cerebral tissue saturation was affected by anesthetic induction ( p < .001 ) , placement of the sternal retractor ( p < .001 ) , and initiation ( p < .001 ) as well as termination of CPB ( p < .001 ) . Placement ( p < .001 ) and removal of the aortic cross-clamp ( p = .026 for left hemisphere , p = .048 for right hemisphere ) led to changes in cerebral tissue saturation . In addition , when placing the aortic crossclamp , hematocrit ( p < .001 ) as well as arterial ( p = .007 ) and venous ( p < .001 ) partial oxygen pressures changed . Cerebral tissue oximetry effectively identifies changes related to surgical events or vulnerable periods during cardiac surgery . Future studies are needed to identify methods of mitigating periods of reduced cerebral saturation Background Blood transfusions are common in cardiac surgery , but have been associated with increased morbidity and long-term mortality . Efforts to reduce blood product use during cardiac surgery include fluid restriction to minimize hemodilution , and protocol s to guide transfusion decisions . INVOS is a modality that monitors brain tissue oxygen saturation , and could be useful in guiding decisions to transfuse . However , the role of INVOS ( brain tissue oxygen saturation ) as part of an algorithm to direct blood transfusions during cardiac surgery has not been evaluated . This study was conducted to investigate the value of INVOS as part of a protocol for blood transfusions during cardiac surgery . Methods Prospect i ve , r and omized , blinded clinical trial , on 150 ( 75 per group ) elective cardiac surgery patients . The study was approved by the Institution Ethics committee and all patients gave written informed consent . Data were initially analyzed based on “ intention to treat ” , but subsequently were also analyzed “ per protocol ” . Results When protocol was strictly followed ( “ per protocol analysis ” ) , compared to the control group , significantly fewer patients monitored with INVOS received any blood transfusions ( 46 of 70 patients in INVOS group vs. 55 of 67 patients in the control group , p = 0.029 ) . Similarly , patients monitored with INVOS received significantly fewer units of red blood cell transfusions intraoperatively ( 0.20 ± 0.50 vs. 0.52 ± 0.88 , p = 0.008 ) and overall during hospital stay ( 1.31 ± 1.20 vs. 1.82 ± 1.46 , p = 0.024 ) . When data from all patients ( including patient with protocol violation ) were analyzed together ( “ intention to treat analysis ” ) , the observed reduction of blood transfusions in the INVOS group was still significant ( 51 of 75 patients transfused in the INVOS group vs. 63 of 75 patients transfused in the control group , p = 0.021 ) , but the overall number of units transfused per patient did not differ significantly between the groups ( 1.55 ± 1.97 vs. 1.84 ± 1.41 , p = 0.288 ) . Conclusions Our data suggest that INVOS could be a useful tool as part of an algorithm to guide decisions for blood transfusion in cardiac surgery . Additional data from rigorous , well design ed studies are needed to further evaluate the role of INVOS in guiding blood transfusions in cardiac surgery , and circumvent the limitations of this study .Trial registration Clinical Trials.gov : Background We assessed whether a near-infrared spectroscopy (NIRS)-based algorithm for the personalized optimization of cerebral oxygenation during cardiopulmonary bypass combined with a restrictive red cell transfusion threshold would reduce perioperative injury to the brain , heart , and kidneys . Methods In a r and omized controlled trial , participants in three UK centres were r and omized with concealed allocation to a NIRS ( INVOS 5100 ; Medtronic Inc. , Minneapolis , MN , USA)-based ' patient-specific ' algorithm that included a restrictive red cell transfusion threshold ( haematocrit 18 % ) or to a ' generic ' non-NIRS-based algorithm ( st and ard care ) . The NIRS algorithm aim ed to maintain cerebral oxygenation at an absolute value of > 50 % or at > 70 % of baseline values . The primary outcome for the trial was cognitive function measured up to 3 months postsurgery . Results The analysis population comprised eligible r and omized patients who underwent valve or combined valve surgery and coronary artery bypass grafts using cardiopulmonary bypass between December 2009 and January 2014 ( n = 98 patient-specific algorithm ; n = 106 generic algorithm ) . There was no difference between the groups for the three core cognitive domains ( attention , verbal memory , and motor coordination ) or for the non-core domains psychomotor speed and visuo-spatial skills . The NIRS group had higher scores for verbal fluency ; mean difference 3.73 ( 95 % confidence interval 1.50 , 5.96 ) . Red cell transfusions , biomarkers of brain , kidney , and myocardial injury , adverse events , and health-care costs were similar between the groups . Conclusions These results do not support the use of NIRS-based algorithms for the personalized optimization of cerebral oxygenation in adult cardiac surgery . Clinical trial registration http://www.controlled-trials.com , IS RCT N 23557269 OBJECTIVES The aim of this study is the assessment of the regional cerebral oximetry - NIRS ( near infrared spectroscopy ) as an intraoperative monitoring system to protect the patient against the incidents of brain desaturations . We hypothesize that patients monitored with NIRS present a smaller range of postoperative cognitive dysfunctions ( POCD ) in comparison with those without NIRS monitoring during lumbar spine surgery in a prone position . SETTING S This study was performed at the Clinical Department of Neurosurgery and Oncology of the Central Nervous System , Medical University of Lodz , Pol and . PARTICIPANTS The study completed 43 adult patients qualified for the surgical treatment of lumbar spondylosis . Before the procedures they were r and omized into two subgroups : one monitored intraoperatively by means of NIRS cerebral oximetry ( INVOS 5100 ) , which numbered 13 patients – 30.2 % ( 13 NIRS devices were made available to the authors ) and the other without NIRS intraoperative monitoring , totaling 30 people – 69.8 % . The patients who presented a history of psychiatric , neurological and cardiovascular disorders which impair cognitive processes were disqualified from the study . PRIMARY AND SECONDARY OUTCOME MEASURES A comprehensive battery of neuropsychological tests was preoperatively performed on all patients . The subjects were then divided into two groups : with and without NIRS monitoring . Both groups were statistically homogeneous . Computerized anesthesia records were used to obtain intraoperative data : mean arterial pressure , heart rate , pulsoximetry and cerebral regional oxygenation . The depth of anesthesia monitor was not used . Besides , all the patients passed the same battery of neurocognitive tests 7 days and 1 month postoperatively . The Mann-Whitney test was performed to compare POCD and therefore assess the usefulness of NIRS as a monitoring mechanism during anesthesia in the prone position . RESULTS There was a significant ( p < 0.05 ) difference in the presence of cognitive deficiencies between the subgroup monitored with NIRS and the subgroup without NIRS . It included : Digit Span Test overall score and forward repetition score 7 days after operation , N- back Test results after 30 days in version 0 " back " - time , N-back Test version 1 " back " results in the number of correct answers and the number of errors . CONCLUSIONS NIRS cerebral oximetry may be useful in reducing postoperative cognitive complications in patients operated on in the prone positioning . TRIAL REGISTRATION RNN/556/08/KB – approval of the ethics committee at Medical University of Lodz , Pol and The use of cerebral oximetry to guide intraoperative management has been shown to improve patient outcomes in cardiac surgery . This pilot trial assessed the feasibility of performing a similar study of outcome in patients over the age of 70 years undergoing non-cardiac surgery . Patients over the age of 70 years undergoing total knee or hip arthroplasty or bowel resection surgery were r and omly assigned to have cerebral oximetry values monitored ( intervention group ) or not monitored ( control ) while under general anaesthesia . Indicators of proof of concept were : rate of complications , rate of cerebral desaturation , relationship between cerebral desaturation and complications , and anaesthetist response to cerebral desaturation . Forty patients were recruited and r and omised to a control group ( n=20 ) or an intervention group ( n=20 ) . The proportion of the study population who had a complication was 40 % ( 95 % confidence interval [ CI ] 26 % to 55 % ) . Cerebral desaturation ( < 75 % of baseline ) occurred in only two patients ( 5.0 % ( CI 1.4 % to 16 % ) ) , one in each group , and neither of those patients recorded a complication . Changes to anaesthetic management on the basis of cerebral oximetry values occurred in only two patients in the intervention group ( 10 % ( CI 2.8 % to 30 % ) ) . Maintenance of cerebral oximetry values appeared to be closer to baseline in the intervention group than in the control group but this difference was not significant ( P=0.15 ) . Our results indicated that complications occurred frequently in the study population but did not appear to be associated with cerebral desaturation events . These findings do not support a larger intervention study using the current study population OBJECTIVE The aim of this study was to compare the effect of sevoflurane and propofol on cerebral oxygenation , using regional cerebral oxygen saturation ( SrO2 ) measured by near-infrared spectroscopy ( NIRS ) . STUDY DESIGN Prospect i ve , r and omized , controlled study . PATIENTS AND METHODS Fifty-four patients aged between 18 and 65 years who underwent elective minor surgery ( tumorectomy for breast cancer or inguinal hernia repair ) were r and omly assigned to receive sevoflurane or propofol anaesthesia . Exclusion criteria included pre-existing cerebrovascular diseases , anaemia , ASA > III , blood loss ≥200 mL , arterial hypotension , baseline pulse oximetry < 97 % , sign of sensor low quality of SrO2 or bispectral index , and patients with a forehead area < 6.5 cm . SrO2 , bispectral index , haemodynamic data and anaesthetic doses were recorded during surgery . RESULTS A total of 48 patients were included in the final analysis ( 24 in each group ) . There were no significant differences in mean , minimum and maximum SrO2 between sevoflurane and propofol groups . The relative maximum decrease was higher in propofol anaesthesia than sevoflurane anaesthesia ( 9.6±10.7 versus 4.2±7.2 % ; P=0.048 ) . Cerebral desaturation ( 20 % reduction from SrO2 baseline during 15 seconds ) occurred in 4 patients in propofol group exclusively ( P=0.109 ) . SrO2 adjusted for baseline was higher in the sevoflurane group than in the propofol group ( 67.3±1.8 % versus 64.2±1.7 % ; P=0.018 ) . There were no significant differences in haemodynamic parameters between the two groups . CONCLUSIONS Cerebral cortical oxygenation measured by NIRS may be better preserved with sevoflurane than with propofol . These findings suggest that sevoflurane anaesthesia could be a good option in patients with compromised cerebral oxygenation , given the absence of intracranial hypertension . Further studies with larger sample sizes are required to support our results Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background The study determined the one year incidence of post operative cognitive decline ( POCD ) and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults ( over 60 years of age ) undergoing elective orthopaedic or abdominal surgery . Methods and Trial Design The design was a prospect i ve cohort study with a nested r and omised , controlled intervention trial , using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery . Results In the 52 week prospect i ve cohort study ( 192 surgical patients and 138 controls ) , mild ( χ2 = 17.9 p<0.0001 ) , moderate ( χ2 = 7.8 p = 0.005 ) and severe ( χ2 = 5.1 p = 0.02 ) POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls . In the nested RCT , 81 patients were r and omized , 73 contributing to the data analysis ( 34 intervention , 39 control ) . In the intervention group mild POCD was significantly reduced at 1 , 12 and 52 weeks ( Fisher ’s Exact Test p = 0.018 , χ2 = 5.1 p = 0.02 and χ2 = 5.9 p = 0.015 ) , and moderate POCD was reduced at 1 and 52 weeks ( χ2 = 4.4 p = 0·037 and χ2 = 5.4 p = 0.02 ) . In addition there was significant improvement in reaction time at all time-points ( Vigilance Reaction Time MWU Z = −2.1 p = 0.03 , MWU Z = −2.7 p = 0.004 , MWU Z = −3.0 p = 0.005 ) , in MMSE at one and 52 weeks ( MWU Z = −2.9 p = 0.003 , MWU Z = −3.3 p = 0.001 ) , and in executive function at 12 and 52 weeks ( Trail Making MWU Z = −2.4 p = .0.018 , MWU Z = −2.4 p = 0.019 ) . Conclusion POCD is common and persistent in older adults following surgery . The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment . Trial Registration Controlled-Trials.com IS RCT Introduction Postoperative delirium is an important problem in patients undergoing major surgery . Cerebral oximetry is a non-invasive method to detect imbalances in the cerebral oxygen supply/dem and -ratio . Low preoperative cerebral oxygen saturation ( ScO2 ) levels have been associated with postoperative delirium in non-cardiac surgery patients . The present prospect i ve observational study determines the relationship between pre- and intra-operative ScO2 levels and postoperative delirium in patients undergoing on-pump cardiac surgery . Methods After approval of the local ethical committee and written informed consent , N = 231 patients scheduled for elective/urgent cardiac surgery were enrolled . Delirium was assessed by the confusion- assessment - method for the intensive care unit ( CAM-ICU ) on the first three days after surgery . ScO2 was obtained on the day before surgery , immediately before surgery and throughout the surgical procedure . Preoperative cognitive function , demographic , surgery related , and intra- and post-operative physiological data were registered . Results Patients with delirium had lower pre- and intra-operative ScO2 readings , were older , had lower mini-mental-status-examination(MMSE ) scores , higher additive EuroScore and lower preoperative haemoglobin-levels . The binary logistic regression identified older age , lower MMSE , neurological or psychiatric disease and lower preoperative ScO2 as independent predictors of postoperative delirium . Conclusions The presented study shows that a low preoperative ScO2 is associated with postoperative delirium after on-pump cardiac surgery Objectives : Cardiac arrest is associated with morbidity and mortality because of cerebral ischemia . Therefore , we tested the hypothesis that higher regional cerebral oxygenation during resuscitation is associated with improved return of spontaneous circulation , survival , and neurologic outcomes at hospital discharge . We further examined the validity of regional cerebral oxygenation as a test to predict these outcomes . Design : Multicenter prospect i ve study of in-hospital cardiac arrest . Setting : Five medical centers in the United States and the United Kingdom . Patients : Inclusion criteria are as follows : in-hospital cardiac arrest , age 18 years old or older , and prolonged cardiopulmonary resuscitation greater than or equal to 5 minutes . Patients were recruited consecutively during working hours between August 2011 and September 2014 . Survival with a favorable neurologic outcome was defined as a cerebral performance category 1–2 . Interventions : Cerebral oximetry monitoring . Measurements and Main Results : Among 504 in-hospital cardiac arrest events , 183 ( 36 % ) met inclusion criteria . Overall , 62 of 183 ( 33.9 % ) achieved return of spontaneous circulation , whereas 13 of 183 ( 7.1 % ) achieved cerebral performance category 1–2 at discharge . Higher mean ± SD regional cerebral oxygenation was associated with return of spontaneous circulation versus no return of spontaneous circulation ( 51.8 % ± 11.2 % vs 40.9 % ± 12.3 % ) and cerebral performance category 1–2 versus cerebral performance category 3–5 ( 56.1 % ± 10.0 % vs 43.8 % ± 12.8 % ) ( both p < 0.001 ) . Mean regional cerebral oxygenation during the last 5 minutes of cardiopulmonary resuscitation best predicted the return of spontaneous circulation ( area under the curve , 0.76 ; 95 % CI , 0.69–0.83 ) ; regional cerebral oxygenation greater than or equal to 25 % provided 100 % sensitivity ( 95 % CI , 94–100 ) and 100 % negative predictive value ( 95 % CI , 79–100 ) ; regional cerebral oxygenation greater than or equal to 65 % provided 99 % specificity ( 95 % CI , 95–100 ) and 93 % positive predictive value ( 95 % CI , 66–100 ) for return of spontaneous circulation . Time with regional cerebral oxygenation greater than 50 % during cardiopulmonary resuscitation best predicted cerebral performance category 1–2 ( area under the curve , 0.79 ; 95 % CI , 0.70–0.88 ) . Specifically , greater than or equal to 60 % cardiopulmonary resuscitation time with regional cerebral oxygenation greater than 50 % provided 77 % sensitivity ( 95 % CI,:46–95 ) , 72 % specificity ( 95 % CI , 65–79 ) , and 98 % negative predictive value ( 95 % CI , 93–100 ) for cerebral performance category 1–2 . Conclusions : Cerebral oximetry allows real-time , noninvasive cerebral oxygenation monitoring during cardiopulmonary resuscitation . Higher cerebral oxygenation during cardiopulmonary resuscitation is associated with return of spontaneous circulation and neurologically favorable survival to hospital discharge . Achieving higher regional cerebral oxygenation during resuscitation may optimize the chances of cardiac arrest favorable outcomes PURPOSE The purpose of this study was to research the use of near-infrared spectroscopy ( NIRS ) on the neurocognitive functions in the patients undergoing coronary artery bypass grafting ( CABG ) with asymptomatic carotid artery disease . METHODS The study design was carried out with the participation of 79 patients in a prospect i ve , r and omized and double blind control method . The patients were separated into two groups as NIRS ( n = 43 ) and no NIRS ( n = 36 ) . A neurocognitive test was applied preoperatively and postoperatively to all patients before discharge . Cognitive functions were evaluated by applying the Montreal Cognitive Assessment test ( MoCA ) . RESULTS The decrease in the postoperative score of mean MoCA in no NIRS group was statistically significant when compared to preoperatively ( p < 0.001 ) . Postoperative mean MoCA score was found to be significantly higher in NIRS group ( NIRS : 26.8 ± 1.9 vs. no NIRS : 23.6 ± 2.5 , p < 0.001 ) . It has been determined that there was a moderately positive significant correlation between the increase in the NIRS used patients ( % ) and increase in the MoCA score of the patients ( r = 0.59 , p < 0.001 ) . CONCLUSION Intraoperative NIRS usage in the patients undergoing CABG with carotid artery disease might be useful due to its postoperative positive effects on the cognitive functions Abstract The objective of this study was to evaluate the effect of hypothermic cardiopulmonary bypass ( CPB ) on cerebral oxygen saturation ( rSO2 ) , internal jugular bulb venous oxygen saturation ( SjvO2 ) , mixed venous oxygen saturation ( SvO2 ) , and bispectral index ( BIS ) used to monitor cerebral oxygen balance in pediatric patients .Sixty American Society of Anesthesiologists Class II-III patients aged 1 to 4 years old with congenital heart disease scheduled for elective cardiac surgery were included in this study . Temperature , BIS , rSO2 , mean arterial pressure , central venous pressure , cerebral perfusion pressure ( CPP ) , and hematocrit were recorded . Internal jugular bulb venous oxygen saturation and SvO2 were obtained from blood gas analysis at the time points : after induction of anesthesia ( T0 ) , beginning of CPB ( T1 ) , ascending aortic occlusion ( T2 ) , 20 minutes after initiating CPB ( T3 ) , coronary reperfusion ( T4 ) , separation from CPB ( T5 ) , and at the end of operation ( T6 ) . The effect of hypothermia or changes in CPP on rSO2 , SjvO2 , SvO2 , and BIS were analyzed . Compared with postinduction baseline values , rSO2 significantly decreased at all-time points : onset of extracorporeal circulation , ascending aortic occlusion , 20 minutes after CPB initiation , coronary reperfusion , and separation from CPB ( P < 0.05 ) . Compared with measurements made following induction of anesthesia , SjvO2 significantly increased with initiation of CPB , ascending aortic occlusion , 20 minutes after initiating CPB , coronary reperfusion , and separation from CPB ( P < 0.05 ) . Compared with induction of anesthesia , BIS significantly decreased with the onset of CPB , aortic cross clamping , 20 minutes after initiating CPB , and coronary reperfusion ( P < 0.05 ) . Bispectral index increased following separation from CPB . There was no significant change in SvO2 during cardiopulmonary bypass ( P > 0.05 ) . Correlation analysis demonstrated that rSO2 was positively related to CPP ( r = 0.687 , P = 0.000 ) , with a low linear correlation to temperature ( r = 0.453 , P = 0.000 ) . Internal jugular bulb venous oxygen saturation was negatively related to temperature ( r = −0.689 , P = 0.000 ) . Bispectral index was positively related to both temperature ( r = 0.824 , P = 0.000 ) and CPP ( r = 0.782 , P = 0.000 ) . Cerebral oxygen saturation had a positive linear correlation with CPP and a low linear correlation to temperature . Internal jugular bulb venous oxygen saturation had a negative linear correlation to temperature . Pre- and and early postbypass periods are vulnerable times for adequate cerebral oxygenation . Anesthetic management must aim to optimize the supply and dem and relationship OBJECTIVES To measure the incidence of cerebral desaturation during high-risk cardiac surgery and to evaluate strategies to reverse cerebral desaturation . DESIGN Prospect i ve observational study followed by a r and omized controlled study with 1 intervention group and 1 control group . SETTING Tertiary care center specialized in cardiac surgery . PARTICIPANTS All patients were scheduled for high-risk cardiac surgery , 279 consecutive patients in the prospect i ve study and 48 patients in the r and omized study . INTERVENTIONS An algorithmic approach of strategies to reverse cerebral desaturation . In the control group , no attempts were made to reverse cerebral desaturation . MEASUREMENTS AND MAIN RESULTS Cerebral saturation was measured using near-infrared reflectance spectroscopy . A decrease of 20 % from baseline for 15 seconds defined cerebral desaturation . The success or failure of the interventions was noted . Demographic data were collected . Models for predicting the probability and the reversal of cerebral desaturation were based on multiple logistic regressions . In the r and omized study , 12 hours of measurements were continued in the intensive care unit without interventions . Differences in desaturation load ( % desaturation × time ) were compared between groups . Half of the high-risk patients had cerebral desaturation that could be reversed 88 % of the time . Interventions result ed in smaller desaturation loads in the operating room and in the intensive care unit . CONCLUSIONS Cerebral desaturation in high-risk cardiac surgery is frequent but can be reversed most of the time result ing in a smaller desaturation load . A large r and omized study will be needed to measure the impact of reversing cerebral desaturation on patient 's outcome There are substantial data supporting the concept that algorithms that effectively limit fluid volumes to patients undergoing elective surgery , particularly intraoperatively , significantly reduce perioperative morbidity . We hypothesized that intraoperative fluid limitation could be safely accomplished when guided by near-infrared spectroscopy ( NIRS ) monitoring , and that this fluid restriction regimen would result in a reduction in postoperative morbidity when compared with st and ard monitoring and fluid therapy . The intent of this pilot study was to demonstrate the feasibility and ease of conduct of this study protocol before exp and ing to the multicenter pivotal trial . We performed a prospect i ve , ( 2:1 ) r and omized , pilot study at two centers . A total enrollment of 24 fully evaluable patients undergoing elective open colorectal surgery ( 16 restricted , 8 st and ard ) was planned . After providing informed consent , patients were r and omized to st and ard fluid resuscitation ( 500 LR induction bolus , then LR 7 mL/kg/h X 1 h , then 5 mL/kg/h ) or restricted fluid resuscitation ( no induction bolus , then LR 2 mL/kg/h ) . Subsequent fluid bolus infusions were guided by physiologic parameters ( systolic blood pressure < 90 mm Hg , heart rate > 100 bpm , or oliguria ) in the st and ard group , and by tissue oxygen saturation from NIRS ( tissue oxygen saturation ( StO2 ) < 75 % , or 20 % below baseline ; or the same physiologic parameters ) in the restricted group . Primary endpoints were major postoperative complications . A total of 27 patients were r and omized ( 18 restricted , 9 st and ard ) . Age , gender , ethnicity , past medical history , and body mass index were similar . American Society of Anesthesiologists class was somewhat higher in the restricted group ( American Society of Anesthesiologists class 3 in 77 % of restricted vs 44 % of st and ard patients ; P = 0.194 ) . Median total intraoperative fluids were less in the restricted group ( 1300 mL ) when compared with the st and ard group ( 3014 mL ) ( P = 0.021 ) . Total fluids for the hospitalization were also statistically significantly decreased in the restricted group . Complications occurred in about two-thirds of patients , and complication rates were not statistically different between groups ( 1.6/restricted patient vs 2.1/st and ard patient ; P = 0.333 ) . Primary indications for boluses ( n = 93 ) given to study patients were : hypotension ( 69 % ) ; oliguria ( 15 % ) ; and tachycardia ( 14 % ) , with multiple indications per bolus . In only two instances did the StO2 drop to less than 75 per cent , or decrease by 20 per cent from baseline in the 3 minutes before bolus as an indication for fluid administration . Patients undergoing elective colorectal surgery with a fluid restricted strategy had only rare episodes of decreased StO2 , suggesting that adequate tissue perfusion was maintained in this group . As a result , NIRS monitoring did not significantly influence intraoperative fluid management of patients undergoing colorectal surgery We studied the effect of sevoflurane and desflurane on regional cerebral oxygenation ( rSO2 ) . Twenty-two patients undergoing abdominal hysterectomy received sevoflurane and desflurane for 15 min each and 30 min apart under steady-state conditions in a r and omized , crossover manner to maintain a bispectral index ( BIS ) of 40–50 . In another 22 patients undergoing the same anesthesia and surgery BIS was maintained at 20–30 . During the 15-min administration of each anesthetic at steady-state conditions rSO2 , BIS , inspired and end-tidal anesthetic concentrations , end-tidal CO2 , Spo2 , systolic and diastolic blood pressures , and heart rate were recorded every 3 min . The rSO2 did not differ between sevoflurane and desflurane when BIS values were maintained between 40–50 or 20–30 . The MACBIS values required to maintain BIS at 40–50 and at 20–30 were 1.0 versus 1.2 ( P = 0.004 ) and 1.6 versus 1.8 ( P < 0.001 ) for desflurane and sevoflurane respectively . Higher rSO2 values were obtained by 1.6 MAC ( 71 ± 13 ) than by 1 MAC of desflurane ( 66 ± 10 ; P < 0.001 ) and by 1.8 MAC ( 72 ± 11 ) than by 1.2 MAC of sevoflurane ( 66 ± 13 ; P < 0.001 ) . In conclusion , equipotent concentrations of desflurane or sevoflurane in terms of BIS are associated with similar rSO2 values , but larger anesthetic concentrations of both anesthetics increased the rSO2 values Postoperative delirium is associated with increased morbidity and mortality . We hypothesised that restoration of regional cerebral oxygen desaturation would reduce the incidence of postoperative delirium in elderly patients after cardiac surgery . After institutional ethics review board approval and informed consent , a double‐blinded , prospect i ve , r and omised , controlled trial was conducted in patients ≥ 60 years of age undergoing cardiac surgery with cardiopulmonary bypass . In the intervention group , an algorithm was commenced if regional cerebral oxygen saturation decreased below 75 % of baseline value for 1 min or longer . In the control group , the cerebral oximetry monitor screen was electronically blinded . Assessment of delirium was performed with confusion assessment method for intensive care unit or confusion assessment method after discharge from intensive care unit at 12‐h intervals for seven postoperative days . Postoperative delirium was present in 30 out of 123 ( 24.4 % ) and 31 out of 126 ( 24.6 % ) patients in the intervention and control groups , respectively , odds ratio 0.98 ( 95%CI 0.55–1.76 ) , p = 0.97 . Postoperative delirium was present in 20 ( 71 % ) out of 28 and in 41 ( 18 % ) out of 221 patients with baseline regional cerebral oxygen saturation ≤ 50 , or > 50 % , respectively , p = 0.0001 . Higher baseline regional cerebral oxygen saturation and body mass index were protective against postoperative delirium . Restoration of regional cerebral oxygen desaturation did not result in lower postoperative delirium after cardiac surgery . Pre‐operative regional cerebral oxygen saturation ≤ 50 % was associated with increased postoperative delirium rates in elderly patients following cardiac surgery BACKGROUND : Cerebral deoxygenation is associated with various adverse systemic outcomes . We hypothesized , by using the brain as an index organ , that interventions to improve cerebral oxygenation would have systemic benefits in cardiac surgical patients . METHODS : Two-hundred coronary artery bypass patients were r and omized to either intraoperative cerebral regional oxygen saturation ( rSO2 ) monitoring with active display and treatment intervention protocol ( intervention , n = 100 ) , or underwent blinded rSO2 monitoring ( control , n = 100 ) . Predefined clinical outcomes were assessed by a blinded observer . RESULTS : Significantly more patients in the control group demonstrated prolonged cerebral desaturation ( P = 0.014 ) and longer duration in the intensive care unit ( P = 0.029 ) versus intervention patients . There was no difference in overall incidence of adverse complications , but significantly more control patients had major organ morbidity or mortality ( death , ventilation > 48 h , stroke , myocardial infa rct ion , return for re-exploration ) versus intervention group patients ( P = 0.048 ) . Patients experiencing major organ morbidity or mortality had lower baseline and mean rSO2 , more cerebral desaturations and longer lengths of stay in the intensive care unit and postoperative hospitalization , than patients without such complications . There was a significant ( r2 = 0.29 ) inverse correlation between intraoperative rSO2 and duration of postoperative hospitalization in patients requiring ≥10 days postoperative length of stay . CONCLUSION : Monitoring cerebral rSO2 in coronary artery bypass patients avoids profound cerebral desaturation and is associated with significantly fewer incidences of major organ dysfunction BACKGROUND We evaluated whether the use of an intraoperative algorithm based on cerebral oximetry with near-infrared refracted spectroscopy ( NIRS ) monitoring , could aid in the intraoperative decision for shunt placement , in patients undergoing carotid endarterectomy ( CEA ) . METHODS In this prospect i ve , r and omized , controlled study were included 253 patients who underwent CEA under general anesthesia . They were r and omly allocated in Group A ( n=83 ) using NIRS monitoring and the suggested algorithm , Group B ( n=84 ) using NIRS monitoring without the algorithm and Group C ( n=86 ) who served as controls . Shunt placement criterion for Group A and B was 20 % drop in ipsilateral regional saturation from the baseline value recorded before surgery . Primary endpoint of the study was to evaluate the use of the intraoperative algorithm based on NIRS monitoring , in the intraoperative decision for shunt placement , in patients undergoing carotid endarterectomy . Additionally , we examined whether this might affect the rate of postoperative neurologic deficits . RESULTS When compared with Group A , Group B and Group C had 3.7 times ( 99 % c.i . 1.5 - 9.5 ) and 70.6 times ( 99 % c.i . 15 - 724.3 ) respectively , greater likelihood of having a shunt placed . When compared with Group B , Group C had 19.4 times ( 99 % c.i . 4.3 - 191.2 ) greater likelihood of having a shunt placed . Regarding the rate of postoperative neurologic deficits no significant difference was found between the three groups . CONCLUSIONS The use of a specific algorithm based on NIRS monitoring , in patients undergoing CEA , may aid in the intraoperative decision for shunt placement BACKGROUND : Patients undergoing surgery in the beach chair position ( BCP ) are at a risk of cerebral ischemia . We evaluated the effect of arginine vasopressin ( AVP ) on hemodynamics and cerebral oxygenation during surgery in the BCP . METHODS : Thirty patients undergoing shoulder surgery in BCP under propofol-remifentanil anesthesia were r and omly allocated either to receive IV AVP 0.07 U/kg ( AVP group , N = 15 ) or an equal volume of saline ( control group , N = 15 ) 2 minutes before taking BCP . Mean arterial blood pressure ( MAP ) , heart rate ( HR ) , jugular venous bulb oxygen saturation ( SjvO2 ) , and regional cerebral tissue oxygen saturation ( SctO2 ) were measured after induction of anesthesia and before ( presitting in supine position ) and after patients took BCP . RESULTS : AVP itself given before the positioning increased MAP and decreased SjvO2 and SctO2 ( P < 0.0001 ) , with HR unaffected . Although MAP was decreased by BCP in both groups , it was higher in the AVP group ( P < 0.0001 ) . While in BCP , HR remained unaltered in the control and decreased in the AVP group . SjvO2 in BCP did not differ between the groups . SctO2 was decreased by BCP in both groups , which was more pronounced in the AVP group until the end of study . The incidence of hypotension ( 13 % vs 67 % ; P = 0.003 ) was less frequent , and that of cerebral desaturation ( > 20 % SctO2 decrease from presitting value ) ( 80 % vs 13 % ; P = 0.0003 ) was higher in the AVP group . The incidence of jugular desaturation ( SjvO2 < 50 % ) was comparable between the groups . CONCLUSIONS : A prophylactic bolus administration of AVP prevents hypotension associated with BCP in patients undergoing shoulder surgery under general anesthesia . However , it was associated with regional cerebral but not jugular venous oxygen desaturation on upright positioning BACKGROUND Time limits for neuroprotection by retro grade cerebral perfusion ( RCP ) and selective cerebral perfusion ( SCP ) in aortic arch aneurysm repair or dissection are undergoing definition . METHODS Using near-infrared optical spectroscopy , changes in regional cerebrovascular oxygen saturation ( rSO2 ) were compared between the two perfusion methods . RESULTS Immediately before cardiopulmonary bypass , baseline rSO2 was 63.9%+/-6.9 % for the RCP and 66.1%+/-5.3 % for the SCP group ( no significant difference ) . As patients were core-cooled to 20 degrees C , rSO2 increased to 73.1%+/-8.8 % and 74.1%+/-7.9 % in the RCP and SCP groups , respectively . With circulatory arrest , rSO2 suddenly decreased . After starting cerebral perfusion , rSO2 returned to prearrest values in the SCP group but continued decreasing steadily in the RCP group , to levels below baseline after about 25 minutes . At the end of perfusion , rSO2 was 57.4%+/-12.2 % for the RCP group and 71.7%+/-6.9 % for the SCP group , and the ratio of rSO2 to baseline value was 0.89 for RCP and 1.08 for SCP despite a shorter brain perfusion time for RCP ( 38.8+/-18.0 versus 103.3+/-43.3 minutes ) . Three of 5 patients whose ratios of rSO2 to baseline at the end of brain protection were 0.7 or less had neurologic deficits . CONCLUSIONS Although SCP showed no clinical ly important time limitation , rSO2 continued to decrease with time during RCP . An rSO2 ratio less than 0.7 could represent a critical lower limit Coronary artery bypass surgery , performed with or without cardiopulmonary bypass , is frequently followed by postoperative cognitive decline . Near‐infrared spectroscopy is commonly used to assess cerebral tissue oxygenation , especially during cardiac surgery . Recent studies have suggested an association between cerebral desaturation and postoperative cognitive dysfunction . We therefore studied cerebral oxygen desaturation , defined as area under the cerebral oxygenation curve < 40 % of > 10 min.% , with respect to cognitive performance at 4 days ( early ) and 3 months ( late ) postoperatively , compared with baseline , using a computerised cognitive test battery . We included 60 patients , of mean ( SD ) age 62.8 ( 9.4 ) years , scheduled for elective coronary artery bypass grafting , who were r and omly allocated to surgery with or without cardiopulmonary bypass . Cerebral desaturation occurred in only three patients and there was no difference in cerebral oxygenation between the two groups at any time . Among patients who received cardiopulmonary bypass , 18 ( 62 % ) had early cognitive decline , compared with 16 ( 53 % ) in the group without cardiopulmonary bypass ( p = 0.50 ) . Three months after surgery , 11 patients ( 39 % ) in the cardiopulmonary bypass group displayed cognitive dysfunction , compared with four ( 14 % ) in the non‐cardiopulmonary bypass group ( p = 0.03 ) . The use of cardiopulmonary bypass was identified as an independent risk factor for the development of late cognitive dysfunction ( OR 6.4 ( 95 % CI 1.2–33.0 ) p = 0.027 . In conclusion , although cerebral oxygen desaturation was rare in our population , postoperative cognitive decline was common in both groups , suggesting that factors other than hypoxic neuronal injury are responsible BACKGROUND Previous studies have reported an 11 % to 75 % incidence of postoperative cognitive decline among cardiac surgery patients . The INVOS Cerebral Oximeter ( Somanetics Corp , Troy , MI ) is a Food and Drug Administration approved device that measures regional cerebral oxygen ( rSo(2 ) ) saturation . The purpose of this study is to examine whether decreased rSo(2 ) predicts cognitive decline and prolonged hospital stay after coronary artery bypass grafting ( CABG ) . METHODS The rSo(2 ) was monitored intraoperatively in a cohort of primary CABG patients . Patients were prospect ively r and omized to a blinded control group or an unblinded intervention group . Cognitive function was assessed preoperatively , postoperatively , and at 3 months using a battery of st and ardized neurocognitive tests . Cognitive decline was defined as a decrease of one st and ard deviation or more in performance on at least one neurocognitive measure . The rSo(2 ) desaturation score was calculated by multiplying rSo(2 ) below 50 % by time ( seconds ) . Multivariate logistic regression models were used to assess cognitive decline and hospital stay . The change in cognitive performance was also assessed using a multivariate linear regression model . RESULTS Patients with rSo(2 ) desaturation score greater than 3,000%-second had a significantly higher risk of early postoperative cognitive decline [ p = 0.024 ] . Patients with rSo(2 ) desaturation score greater than 3,000%-second also had a near threefold increased risk of prolonged hospital stay ( > 6 days ) [ p = 0.007 ] . CONCLUSIONS Intraoperative cerebral oxygen desaturation is significantly associated with an increased risk of cognitive decline and prolonged hospital stay after CABG Elderly patients are more prone than younger patients to develop cerebral desaturation because of the reduced physiologic reserve that accompanies aging . To evaluate whether monitoring cerebral oxygen saturation ( rSO2 ) minimizes intraoperative cerebral desaturation , we prospect ively monitored rSO2 in 122 elderly patients undergoing major abdominal surgery with general anesthesia . Patients were r and omly allocated to an intervention group ( the monitor was visible and rSO2 was maintained at ≥75 % of preinduction values ; n = 56 ) or a control group ( the monitor was blinded and anesthesia was managed routinely ; n = 66 ) . Cerebral desaturation ( rSO2 reduction < 75 % of baseline ) was observed in 11 patients of the treatment group ( 20 % ) and 15 patients of the control group ( 23 % ) ( P = 0.82 ) . Mean ( 95 % confidence intervals ) values of mean rSO2 were higher ( 66 % [ 64%–68 % ] ) and the area under the curve below 75 % of baseline ( AUCrSO22 < 75 % of baseline ) was lower ( 0.4 min% [ 0.1–0.8 min% ] ) in patients of the treatment group than in patients of the control group ( 61 % [ 59%–63 % ] and 80 min% [ 2–144 min% ] , respectively ; P = 0.002 and P = 0.017 ) . When considering only patients developing intraoperative cerebral desaturation , a lower Mini Mental State Elimination ( MMSE ) score was observed at the seventh postoperative day in the control group ( 26 [ 25–30 ] ) than in the treatment group ( 28 [ 26–30 ] ) ( P = 0.02 ) , with a significant correlation between the AUCrSO2 < 75 % of baseline and postoperative decrease in MMSE score from preoperative values ( r2= 0.25 , P = 0.01 ) . Patients of the control group with intraoperative cerebral desaturation also experienced a longer time to postanesthesia care unit ( PACU ) discharge ( 47 min [ 13–56 min ] ) and longer hospital stay ( 24 days [ 7–53 ] days ) compared with patients of the treatment group ( 25 min [ 15–35 min ] and 10 days [ 7–23 days ] , respectively ; P = 0.01 and P = 0.007 ) . Using rSO2 monitoring to manage anesthesia in elderly patients undergoing major abdominal surgery reduces the potential exposure of the brain to hypoxia ; this might be associated with decreased effects on cognitive function and shorter PACU and hospital stay OBJECTIVES Postoperative cognitive decline is common after cardiac surgery , but it is often unrecognized at the time of hospital discharge . However , it has a great impact on patient 's quality of life . Cerebral oximetry with the INVOS ( IN Vivo Optical Spectroscopy ) system provides the possibility of non-invasive , continuous measurement of regional cerebral oxygen saturation ( rSO2 ) , which can improve patients ' outcome . The aim of this study was to examine whether cerebral oximetry can decrease the incidence of cognitive decline after coronary artery bypass grafting . METHODS We have performed a prospect i ve , r and omized study with 200 patients enrolled . Patients were divided into INVOS interventional group and CONTROL group without monitoring of cerebral oximetry . A st and ardized interventional protocol was performed in the INVOS group to maintain rSO2 above 80 % of the patient 's baseline value or above 50 % of the absolute value . Cognitive evaluation was performed in all patients before and 7 days after surgery . Logistic regression was used to reveal predictors of cognitive decline . RESULTS The incidence of cognitive decline 7 days after surgery was significantly lower ( P = 0.002 ) in the INVOS interventional group ( 28 % ) than in the CONTROL group ( 52 % ) . Intraoperative use of INVOS monitoring was associated with lower incidence of cognitive decline ( odds ratio 0.21 ) . In addition , predictors of cognitive decline revealed by multivariate logistic regression were older age , higher EuroSCORE and SAPS II ( Simplified Acute Physiology Score ) values , lower educational level and persistence of preoperative atrial fibrillation . Patients with prolonged rSO2 desaturation , defined as rSO2 area under the curve ( AUC ) of more than 150 min% for desaturation below 20 % of baseline or AUC of more than 50 min% for desaturation below 50 % absolute value , had an increased risk of cognitive decline . CONCLUSION Postoperative cognitive outcome was significantly better in patients with intraoperative cerebral oximetry monitoring . Prolonged rSO2 desaturation is a predictor of cognitive decline and has to be avoided Background : Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes . Before a large multicenter r and omized controlled trial ( RCT ) on the impact of preventing desaturations on perioperative outcomes , the authors undertook a r and omized prospect i ve , parallel-arm , multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations . Methods : Eight Canadian sites r and omized 201 patients between April 2012 and October 2013 . The primary outcome was the success rate of reversing cerebral desaturations below 10 % relative to baseline in the intervention group . Anesthesiologists were blinded to the cerebral saturation values in the control group . Intensive care unit personnel were blinded to cerebral saturation values for both groups . Secondary outcomes included the area under the curve of cerebral desaturation load , enrolment rates , and a 30-day follow-up for adverse events . Results : Cerebral desaturations occurred in 71 ( 70 % ) of the 102 intervention group patients and 56 ( 57 % ) of the 99 control group patients ( P = 0.04 ) . Reversal was successful in 69 ( 97 % ) of the intervention group patients . The mean cerebral desaturation load ( SD ) in the operating room was smaller for intervention group patients compared with control group patients ( 104 [ 217 ] % .min vs. 398 [ 869 ] % .min , mean difference , −294 ; 95 % CI , −562 to −26 ; P = 0.03 ) . This was also true in the intensive care unit ( P = 0.02 ) . There were no differences in adverse events between the groups . Conclusions : Study sites were successful in reversal of desaturation , patient recruitment , r and omization , and follow-up in cardiac surgery , supporting the feasibility of conducting a large multicenter RCT AIMS AND OBJECTIVES We studied the usefulness of regional cerebral oxygen saturation ( rSO 2 ) monitoring during cardiopulmonary bypass ( CPB ) and evaluated effects of cerebral oxygen desaturation on the postoperative neurological outcome . MATERIAL S AND METHODS 100 patients were r and omly allocated to either control or intervention group . In the control group rSO 2 was recorded continuously , but the attending anesthesiologist was blinded . In the intervention group specific interventions were initiated in case of cerebral desaturation . Neurocognitive testing was done using a simplified antisaccadic eye movement test ( ASEM ) and mini-mental state examination ( MMSE ) . Data was analyzed using Chi-square test , and unpaired t-test . RESULTS In both the groups rSO 2 declined during CPB . The decrease in rSO 2 was significant ( P < 0.001 ) in the control group compared to the intervention group . In the intervention group the rSO 2 mainly responded to an increase in mean arterial pressure . The area under the curve below threshold rSO 2 was significantly more ( P < 0.0001 ) in the control group compared to intervention group and a significant decrease in the MMSE and ASEM scores occurred in control group at one week and three months postoperatively . CONCLUSIONS Monitoring of rSO 2 during CPB can significantly decrease the incidence of postoperative neurocognitive decline Background Delirium affects 20–30 % of patients after cardiac surgery and is associated with increased mortality and persistent cognitive decline . Hyperoxic reperfusion of ischemic tissues increases oxidative injury , but oxygen administration remains high during cardiac surgery . We tested the hypothesis that intraoperative hyperoxic cerebral reperfusion is associated with increased postoperative delirium and that oxidative injury mediates this association . Methods We prospect ively measured cerebral oxygenation with bilateral oximetry monitors in 310 cardiac surgery patients , quantified intraoperative hyperoxic cerebral reperfusion by measuring the magnitude of cerebral oxygenation above baseline after any ischemic event , and assessed patients for delirium twice daily in the ICU following surgery using the confusion assessment method for ICU ( CAM‐ICU ) . We examined the association between hyperoxic cerebral reperfusion and postoperative delirium , adjusted for the extent of cerebral hypoxia , the extent of cerebral hyperoxia prior to any ischemia , and additional potential confounders and risk factors for delirium . To assess oxidative injury mediation , we examined the association between hyperoxic cerebral reperfusion and delirium after further adjusting for plasma levels of F2‐isoprostanes and isofurans at baseline and ICU admission , the association between hyperoxic cerebral reperfusion and these markers of oxidative injury , and the association between these markers and delirium . Results Ninety of the 310 patients developed delirium following surgery . Every 10%·hour of intraoperative hyperoxic cerebral reperfusion was independently associated with a 65 % increase in the odds of delirium ( OR , 1.65 [ 95 % CI , 1.12–2.44 ] ; P=0.01 ) . Hyperoxia prior to ischemia was also independently associated with delirium ( 1.10 [ 1.01–1.19 ] ; P=0.02 ) , but hypoxia was not ( 1.12 [ 0.97–1.29 ] ; P=0.11 ) . Increased hyperoxic cerebral reperfusion was associated with increased concentrations of F2‐isoprostanes and isofurans at ICU admission , increased concentrations of these markers were associated with increased delirium , and the association between hyperoxic cerebral reperfusion and delirium was weaker after adjusting for these markers of oxidative injury . Conclusions Intraoperative hyperoxic cerebral reperfusion was associated with increased postoperative delirium , and increased oxidative injury following hyperoxic cerebral reperfusion may partially mediate this association . Further research is needed to assess the potential deleterious role of cerebral hyper‐oxygenation during surgery . Graphical abstract Figure . No Caption Available . HighlightsCerebral oxygenation fluctuates considerably during cardiac surgery . Cerebral hyperoxia after hypoxia was strongly associated with delirium . Hyperoxia independent of hypoxia was also associated with postoperative delirium . Hypoxia was not associated with delirium . Intraoperative oxidative injury may partially mediate these effects |
1,326 | 30,160,009 | Thematic synthesis of 14 qualitative studies found that parents serve the portion sizes they learn to be appropriate for their child to be fed .
Portioning is influenced by parents ' desires for a healthy child with a balanced diet . | Consumption of larger portion sizes is associated with higher energy intake and weight status in children .
As parents play a pivotal role in child feeding , we synthesized literature on ' parental portioning practice s ' using a mixed methods systematic design to inform future strategies addressing portion sizes served to children . | The energy density ( ED ; kcal/g ) of an entrée influences children 's energy intake ( EI ) , but the effect of simultaneously changing both ED and portion size of an entrée on preschool children 's EI is unknown . In this within-subject crossover study , 3- to 5-year-old children ( 30 boys , 31 girls ) in a daycare facility were served a test lunch once/week for 4 weeks . The amount and type of vegetables and cheeses incorporated into the sauce of a pasta entrée were manipulated to create two versions that varied in ED by 25 % ( 1.6 or 1.2 kcal/g ) . Across the weeks , each version of the entrée was served to the children in each of two portion sizes ( 400 or 300 g ) . Lunch , consumed ad libitum , also included carrots , applesauce , and milk . Decreasing ED of the entrée by 25 % significantly ( P<0.0001 ) reduced children 's EI of the entrée by 25 % ( 63.1+/-8.3 kcal ) and EI at lunch by 17 % ( 60.7+/-8.9 kcal ) . Increasing the proportion of vegetables in the pasta entrée increased children 's vegetable intake at lunch by half of a serving of vegetables ( P<0.01 ) . Decreasing portion size of the entrée by 25 % did not significantly affect children 's total food intake or EI at lunch . Therefore , reducing the ED of a lunch entrée result ed in a reduction in children 's EI from the entrée and from the meal in both portion size conditions . Decreasing ED by incorporating more vegetables into recipes is an effective way of reducing children 's EI while increasing their vegetable intake Summary Background Increases in portion size are thought by many to promote obesity in children . However , this relationship remains unclear . Here , we explore the extent to which a child 's BMI is predicted both by parental beliefs about their child 's ideal and maximum portion size and /or by the child 's own beliefs . Methods Parent – child ( 5–11 years ) dyads ( N = 217 ) were recruited from a r and omized controlled trial ( n = 69 ) and an interactive science centre ( n = 148 ) . For a range of main meals , parents estimated their child 's ‘ ideal ’ and ‘ maximum tolerated ’ portions . Children completed the same tasks . Results An association was found between parents ' beliefs about their child 's ideal ( β = .34 , p < .001 ) and maximum tolerated ( β = .30 , p < .001 ) portions , and their child 's BMI . By contrast , children 's self‐reported ideal ( β = .02 , p = .718 ) and maximum tolerated ( β = −.09 , p = .214 ) portions did not predict their BMI . With increasing child BMI , parents ' estimations aligned more closely with their child 's own selected portions . Conclusions Our findings suggest that when a parent selects a smaller portion for their child than their child self‐selects , then the child is less likely to be obese . Therefore , public health measures to prevent obesity might include instructions to parents on appropriate portions for young children BACKGROUND Informed and engaged parents and healthful home environments are essential for the health of youth . Although research has shown health benefits associated with family meals , to date , no r and omized controlled trial ( RCT ) has been developed to examine the impact of a family meals intervention on behavioral and health outcomes . METHODS / DESIGN The Healthy Home Offerings via the Mealtime Environment ( HOME ) Plus study is a two-arm ( intervention versus attention-only control ) RCT being conducted in Minneapolis/St . Paul . Built on previous pilot research , HOME Plus aims to increase the frequency and healthfulness of family meals and snacks and reduce children 's sedentary behavior , particularly screen time , to promote healthier eating and activity behaviors and prevent obesity . HOME Plus is delivered to families in community setting s. The program includes 10 monthly sessions focused on nutrition and activity education , meal planning and preparation skill development . In addition , five motivational goal - setting phone calls are conducted with parents . The primary outcome measure is age- and gender-adjusted child BMI -z score at post-intervention by treatment group . Secondary household-level outcomes include family meal frequency , home availability of healthful foods ( fruits/vegetables ) and unhealthful foods ( high-fat/sugary snacks ) and beverages ( sugar-sweetened beverages ) , and the quality of foods served at meals and snacks . Secondary child outcomes include dietary intake of corresponding foods and beverages and screen time . CONCLUSIONS The HOME Plus RCT actively engages whole families of 8 - 12 year old children to promote healthier eating and activity behaviors and prevent obesity through promotion of family meals and snacks and limited media use BACKGROUND Previous portion size research in children has focused on the impact of large entrée portions on children 's intake , but less attention has been given to how intake at a meal is affected across a broader range of entrée portions . OBJECTIVE The objective was to assess the effect of serving a range of entrée portions on children 's ad libitum intake and energy density consumed at the meal . DESIGN A within-subject design was used to examine the effect of varying entrée portions ( ie , 100 , 160 , 220 , 280 , 340 , and 400 g ) on children 's ad libitum energy intake of macaroni and cheese and fixed portions of unsweetened applesauce , green beans , and whole-wheat roll served with the entree . Seventeen children ( 10 girls ) , aged 3 to 6 y , were served a series of 6 lunches , which varied only in entrée portion size , once per week . Weight , height , and weighed food intake were measured . RESULTS Increasing portion size increased children 's entrée intake ( P < 0.01 ) and decreased intake of other foods served with the entrée , including fruit and vegetables ( P < 0.0001 ) . As a result , children consumed a more-energy-dense ( kcal/g ) lunch as portion size increased ( P < 0.0001 ) . Further examination showed that BMI percentile moderated the positive association between portion size and entrée intake ( P < 0.01 ) ; overweight children showed greater increases in entree intake with increasing entrée portion . CONCLUSION Serving smaller age-appropriate entrée portions may be one strategy to improve children 's nutritional profile by decreasing intake of energy-dense foods and by promoting intake of fruit and vegetables served with the entree BACKGROUND Research has demonstrated a significant positive association between frequent family meals and children 's dietary intake ; however , the promotion of healthful family meals has not been rigorously tested for key food environment and nutrition-related behavioral outcomes in a r and omized trial . OBJECTIVE To describe family home food environment and nutrition-related parent and child personal and behavioral outcomes of the Healthy Home Offerings via the Mealtime Environment Plus program , the first rigorously tested family meals intervention targeting childhood obesity prevention . DESIGN R and omized controlled trial . Baseline , postintervention ( 12 months , 93 % retention ) , and follow-up ( 21 months , 89 % retention ) data ( surveys and dietary recalls ) were collected . PARTICIPANTS / SETTING Children aged 8 to 12 years ( N=160 ) and their parents were r and omized to intervention ( n=81 ) or control ( n=79 ) groups . INTERVENTION The intervention included five parent goal - setting calls and 10 monthly sessions delivered to families in community setting s that focused on experiential nutrition activities and education , meal planning , cooking skill development , and reducing screen time . MAIN OUTCOME MEASURES Family home food environment outcomes and nutrition-related child and parent personal and behavioral outcomes . STATISTICAL ANALYSES PERFORMED Analyses used generalized linear mixed models . Primary comparisons were contrasts between intervention and control groups at postintervention and follow-up , with adjustments for child age and parent education . RESULTS Compared with control parents , intervention parents showed greater improvement over time in scores of self-efficacy for identifying appropriate portion sizes , with significant differences in adjusted means at both post-intervention ( P=0.002 ) and follow-up ( P=0.01 ) . Intervention children were less likely to consume at least one sugar-sweetened beverage daily at post-intervention than control children ( P=0.04 ) . CONCLUSIONS The Healthy Home Offerings via the Mealtime Environment Plus program involved the entire family and targeted personal , behavioral , and environment factors important for healthful changes in the home food environment and children 's dietary intake . The intervention improved two nutrition-related behaviors and this may inform the design of future family meal interventions |
1,327 | 26,092,137 | Regarding the route of antibiotic administration , vaginal antibiotic prophylaxis during pregnancy did not prevent infectious pregnancy outcomes .
Antibiotic prophylaxis did not reduce the risk of preterm prelabour rupture of membranes or preterm delivery ( apart from in the subgroup of women with a previous preterm birth who had bacterial vaginosis ) .
Antibiotic prophylaxis given during the second or third trimester of pregnancy reduced the risk of postpartum endometritis , term pregnancy with pre-labour rupture of membranes and gonococcal infection when given routinely to all pregnant women .
Therefore , we conclude that there is not enough evidence to support the use of routine antibiotics during pregnancy to prevent infectious adverse effects on pregnancy outcomes | BACKGROUND Several studies have suggested that prophylactic antibiotics given during pregnancy improved maternal and perinatal outcomes , while others have shown no benefit and some have reported adverse effects .
OBJECTIVES To determine the effect of prophylactic antibiotics on maternal and perinatal outcomes during the second and third trimester of pregnancy for all women or women at risk of preterm delivery . | Background Intermittent preventive treatment in pregnancy has not been evaluated outside of Africa . Low birthweight ( LBW , < 2,500 g ) is common in Papua New Guinea ( PNG ) and contributing factors include malaria and reproductive tract infections . Methods From November 2009 to February 2013 , we conducted a parallel group , r and omised controlled trial in pregnant women ( ≤26 gestational weeks ) in PNG . Sulphadoxine-pyrimethamine ( 1,500/75 mg ) plus azithromycin ( 1 g twice daily for 2 days ) ( SPAZ ) monthly from second trimester ( intervention ) was compared against sulphadoxine-pyrimethamine and chloroquine ( 450 to 600 mg , daily for three days ) ( SPCQ ) given once , followed by SPCQ placebo ( control ) . Women were assigned to treatment ( 1:1 ) using a r and omisation sequence with block sizes of 32 . Participants were blinded to assignments . The primary outcome was LBW . Analysis was by intention-to-treat . Results Of 2,793 women r and omised , 2,021 ( 72.4 % ) were included in the primary outcome analysis ( SPCQ : 1,008 ; SPAZ : 1,013 ) . The prevalence of LBW was 15.1 % ( 305/2,021 ) . SPAZ reduced LBW ( risk ratio [ RR ] : 0.74 , 95 % CI : 0.60–0.91 , P = 0.005 ; absolute risk reduction ( ARR ) : 4.5 % , 95 % CI : 1.4–7.6 ; number needed to treat : 22 ) , and preterm delivery ( 0.62 , 95 % CI : 0.43–0.89 , P = 0.010 ) , and increased mean birthweight ( 41.9 g , 95 % CI : 0.2–83.6 , P = 0.049 ) . SPAZ reduced maternal parasitaemia ( RR : 0.57 , 95 % CI : 0.35–0.95 , P = 0.029 ) and active placental malaria ( 0.68 , 95 % CI : 0.47–0.98 , P = 0.037 ) , and reduced carriage of gonorrhoea ( 0.66 , 95 % CI : 0.44–0.99 , P = 0.041 ) at second visit . There were no treatment-related serious adverse events ( SAEs ) , and the number of SAEs ( intervention 13.1 % [ 181/1,378 ] , control 12.7 % [ 174/1,374 ] , P = 0.712 ) and AEs ( intervention 10.5 % [ 144/1,378 ] , control 10.8 % [ 149/1,374 ] , P = 0.737 ) was similar . A major limitation of the study was the high loss to follow-up for birthweight . Conclusions SPAZ was efficacious and safe in reducing LBW , possibly acting through multiple mechanisms including the effect on malaria and on sexually transmitted infections . The efficacy of SPAZ in the presence of resistant parasites and the contribution of AZ to bacterial antibiotic resistance require further study . The ability of SPAZ to improve pregnancy outcomes warrants further evaluation . Trial registration Clinical Trials.gov NCT01136850 ( 06 April 2010 ) Because sub clinical genital tract infection may play a major role in preterm birth , the efficacy of adjunctive antibiotic therapy in combination with st and ard parenteral tocolysis was examined in a r and omized , blinded study of patients with idiopathic preterm labor . Labor was documented by three contractions in 20 minutes , cervical dilation of 1 cm or more , and the need for parenteral tocolysis . Enrollment was restricted to patients with intact membranes and without known causes for preterm labor . One hundred three patients at 24–34 weeks ' gestation were r and omized to intravenous ampicillin plus oral erythromycin or corresponding placebos . Compared with the placebo group , the adjunctive antibiotic group had a similar frequency of preterm birth ( 38 versus 44 % ) , time to delivery ( 34 versus 34 days ) , birth weight ( 2847 versus 2855 g ) , and episodes of recurrent labor requiring parenteral tocolysis ( 0.43 versus 0.49 ) . In our population , we found no benefit to the adjunctive use of ampicillin plus erythromycin . Significant differences in genital microflora between our patients and those of other studies may explain our results Low birth-weight is a leading health problem in developing countries . In a r and omized controlled trial , the effect of antimicrobials in pregnant women on improving birth-weight and duration of gestation was evaluated . Two hundred twenty-four pregnant women in their second trimester were r and omized to receive metronidazole ( 200 mg 3 times daily for 7 days ) and cephalexin ( 500 mg twice daily for 5 days ) orally by one group . The mean ( + /-SD ) birth-weights were 2,545 g ( + /-374 ) and 2584 g ( + /-358 , p=0.51 ) , the low birth-weight rates ( < 2.5 kg ) were 40 % and 36 % ( p = 0.28 ) , and the prematurity rates were 8 % and 11 % ( p = 0.6 ) in the treated group and the control group respectively . Due to small sample size , it is cautiously concluded that routine antimicrobials for genital and urinary tract infections of pregnant women do not improve birth-weight or duration of gestation . Rather an unexpected observation was the proportion requiring caesarian section or forceps , which was five-fold higher in the treated group ( p = 0.001 ) , and given no plausible explanations , this finding needs confirmation . Stunted mothers ( < 25th centile or 146.4 cm ) had two-fold higher risk for low birth-weight ( p = 0.04 ) and assisted delivery ( p = 0.1 ) . Low maternal body mass index ( < 25th centile or 18 ) had six-fold higher risk for stillbirth or abortion ( p = 0.007 ) , and high body mass index ( > 75th centile or 21.2 ) had three-fold higher risk for assisted delivery ( p = 0.003 ) OBJECTIVE The purpose of this study was to assess the association of presumptive Trichomonas vaginalis treatment during pregnancy and birth outcomes . STUDY DESIGN A community-r and omized trial of presumptive sexually transmitted disease treatment during pregnancy was conducted between 1994 and 1999 in Rakai district , Ug and a. A sub analysis of a trial of presumptive therapy with azithromycin , cefixime , and metronidazole assessed Trichomonas vaginalis treatment in pregnant women . RESULTS Children of 94 women with Trichomonas who were treated had increased low birth weight ( relative risk , 2.49 ; 95 % CI , 1.12 - 5.50 ) , preterm birth rate ( relative risk , 1.28 ; 95 % CI , 0.81 - 2.02 ) , and 2-year mortality rate ( relative risk , 1.58 ; 95 % CI , 0.99 - 2.52 ) , compared with children of 112 women with Trichomonas who were not treated . CONCLUSION Treatment of Trichomonas vaginalis during pregnancy may be deleterious , and we infer that this may be due to metronidazole . This is consistent with a National Institute for Child Health and Human Development trial that found an excess of preterm births in children of women with Trichomonas vaginalis infection who were treated with metronidazole BACKGROUND Pregnant women with bacterial vaginosis may be at increased risk for preterm delivery . We investigated whether treatment with metronidazole and erythromycin during the second trimester would lower the incidence of delivery before 37 weeks ' gestation . METHODS In 624 pregnant women at risk for delivering prematurely , vaginal and cervical cultures and other laboratory tests for bacterial vaginosis were performed at a mean of 22.9 weeks ' gestation . We then performed a 2:1 double-blind r and omization to treatment with metronidazole and erythromycin ( 433 women ) or placebo ( 191 women ) . After treatment , the vaginal and cervical tests were repeated and a second course of treatment was given to women who had bacterial vaginosis at that time ( a mean of 27.6 weeks ' gestation ) . RESULTS A total of 178 women ( 29 percent ) delivered infants at less than 37 weeks ' gestation . Eight women were lost to follow-up . In the remaining population , 110 of the 426 women assigned to metronidazole and erythromycin ( 26 percent ) delivered prematurely , as compared with 68 of the 190 assigned to placebo ( 36 percent , P = 0.01 ) . However , the association between the study treatment and lower rates of prematurity was observed only among the 258 women who had bacterial vaginosis ( rate of preterm delivery , 31 percent with treatment vs. 49 percent with placebo ; P = 0.006 ) . Of the 358 women who did not have bacterial vaginosis when initially examined , 22 percent of those assigned to metronidazole and erythromycin and 25 percent of those assigned to placebo delivered prematurely ( P = 0.55 ) . The lower rate of preterm delivery among the women with bacterial vaginosis who were assigned to the study treatment was observed both in women at risk because of previous preterm delivery ( preterm delivery in the treatment group , 39 percent ; and in the placebo group , 57 percent ; P = 0.02 ) and in women who weighed less than 50 kg before pregnancy ( preterm delivery in the treatment group , 14 percent ; and in the placebo group , 33 percent ; P = 0.04 ) . CONCLUSIONS Treatment with metronidazole and erythromycin reduced rates of premature delivery in women with bacterial vaginosis and an increased risk for preterm delivery OBJECTIVE The purpose of this study was to determine the impact of persistent bacterial vaginosis ( BV ) on the occurrence of spontaneous preterm birth ( SPB ) in women who test positive for fetal fibronectin . STUDY DESIGN This is a secondary analysis of a subset of pregnant women who tested positive for BV and fetal fibronectin between 16(0/7 ) and 25(6/7 ) weeks of gestation and who participated in r and omized placebo controlled trials of antibiotic therapy . Nugent 's criteria were used for the diagnosis of BV . Patients were reassessed for the presence of BV after treatment . The rate of SPB at < 34 weeks of gestation was analyzed on the basis of treatment mode and BV status at the follow-up visit . RESULTS The primary studies included a total of 3285 women . A subset of 215 women met the criteria for this analysis . Seventy-seven of 100 patients ( 77 % ) in the antibiotics group vs 33 of the 115 patients ( 28.7 % ) in the placebo group became BV negative ( P < .0001 ) . The rate of SPB at < 34 weeks of gestation was lower for BV resolution compared with persistent BV ( 0 vs 5.7 % , respectively ; P = .01 ) . CONCLUSION In women who tested positive for fetal fibronectin and BV , resolution of BV is associated with less SPB before 34 weeks of gestation BACKGROUND The ORACLE II trial compared the use of erythromycin and /or amoxicillin-clavulanate ( co-amoxiclav ) with that of placebo for women in spontaneous preterm labour and intact membranes , without overt signs of clinical infection , by use of a factorial r and omised design . The aim of the present study --the ORACLE Children Study II -- was to determine the long-term effects on children after exposure to antibiotics in this clinical situation . METHODS We assessed children at age 7 years born to the 4221 women who had completed the ORACLE II study and who were eligible for follow-up with a structured parental question naire to assess the child 's health status . Functional impairment was defined as the presence of any level of functional impairment ( severe , moderate , or mild ) derived from the mark III Multi-Attribute Health Status classification system . Educational outcomes were assessed with national curriculum test results for children resident in Engl and . FINDINGS Outcome was determined for 3196 ( 71 % ) eligible children . Overall , a greater proportion of children whose mothers had been prescribed erythromycin , with or without co-amoxiclav , had any functional impairment than did those whose mothers had received no erythromycin ( 658 [ 42.3 % ] of 1554 children vs 574 [ 38.3 % ] of 1498 ; odds ratio 1.18 , 95 % CI 1.02 - 1.37 ) . Co-amoxiclav ( with or without erythromycin ) had no effect on the proportion of children with any functional impairment , compared with receipt of no co-amoxiclav ( 624 [ 40.7 % ] of 1523 vs 608 [ 40.0 % ] of 1520 ; 1.03 , 0.89 - 1.19 ) . No effects were seen with either antibiotic on the number of deaths , other medical conditions , behavioural patterns , or educational attainment . However , more children whose mothers had received erythromycin or co-amoxiclav developed cerebral palsy than did those born to mothers who received no erythromycin or no co-amoxiclav , respectively ( erythromycin : 53 [ 3.3 % ] of 1611 vs 27 [ 1.7 % ] of 1562 , 1.93 , 1.21 - 3.09 ; co-amoxiclav : 50 [ 3.2 % ] of 1587 vs 30 [ 1.9 % ] of 1586 , 1.69 , 1.07 - 2.67 ) . The number needed to harm with erythromycin was 64 ( 95 % CI 37 - 209 ) and with co-amoxiclav 79 ( 42 - 591 ) . INTERPRETATION The prescription of erythromycin for women in spontaneous preterm labour with intact membranes was associated with an increase in functional impairment among their children at 7 years of age . The risk of cerebral palsy was increased by either antibiotic , although the overall risk of this condition was low . FUNDING UK Medical Research Council 115 women , distributed in 20 centres , were included in a r and omized study design ed to assess the efficacy of Polygynax in preventing vaginal infections in women at risk , at the start of pregnancy . Polygynax proved to be markedly effective since only 9.6 % of the patients in the Polygynax group had a vaginal infection , in contrast to 42.6 % of the patients in the control group . This result is highly significant ( p less than 0.0001 ) and confirms the advantage attached to the use of Polygynax when a first line treatment involving the use of several drugs in combination is indicated OBJECTIVE : To evaluate whether vaginal flora is altered by antibiotic exposure and associated with a risk of preterm birth , particularly among women with initially normal vaginal flora . METHODS : This was a secondary analysis of a r and omized trial of metronidazole and erythromycin for the prevention of preterm birth among women with a positive fetal fibronectin test . Vaginal swabs for Nugent Gram stain score were collected for classification of bacterial vaginosis before and after antibiotic exposure and read at a central laboratory . Change in Nugent score was assessed for women with ( score 7 or higher ) or without ( score lower than 7 ) bacterial vaginosis . Linear regression analysis evaluated whether change in Nugent score was associated with preterm birth . RESULTS : Two hundred women without and 69 women with bacterial vaginosis had Gram stain performed before and after antibiotic therapy . Median Nugent score for all women declined from 4.0 to 2.0 after antibiotic therapy ( P<.001 ) . Nugent score declined both for those without ( from 2.0 to 1.5 , P=.11 ) and , more dramatically , those with bacterial vaginosis ( from 8.0 to 3.0 , P<.01 ) . The components of the Nugent score that were affected by antibiotic exposure were similar among women with and without bacterial vaginosis . Antibiotic exposure and the change in Nugent score were unrelated to preterm birth among bacterial vaginosis-negative women . CONCLUSION : Antibiotic exposure is not associated with preterm birth and does not worsen Nugent score among women with normal vaginal flora and positive fetal fibronectin . LEVEL OF EVIDENCE : Objective : The objective of this study was to determine whether prophylactic treatment with oral broad-spectrum antimicrobial therapy improves pregnancy outcomes in twin gestations . Methods : Patients with twin gestations between 24 and 32 weeks were r and omized to receive amoxicillin/clavulanic acid or placebo . Those patients r and omized before 24 weeks received a 1-week course at 24 and at 28 weeks gestation . Those patients entered later than 24 weeks received a 1-week course either at 28 weeks or at enrollment ( up to 32 weeks ) . Other than antibiotic use , the management of the groups was identical and unchanged from the routine care of twin gestations . Results : Of 149 twin pregnancies enrolled , 76 were r and omized to the drug group and 73 to the placebo group . There was no significant difference in mean gestational age at delivery ( 35.9 vs. 35.7 weeks ) , birth weight ( 2,358 vs. 2,344 g ) , mean neonatal nursery stay ( 9.9 vs. 11.7 days ) , or respiratory distress syndrome ( 6/76 vs. 4/73 ) in the drug vs. placebo group , respectively . Conclusions : The addition of prophylactic oral broad-spectrum antimicrobial therapy to the st and ard antepartum management of twin gestations had no demonstrable effect on the gestational age at delivery , birth weight , or neonatal complications . There did not appear to be any beneficial effect of the prophylactic use of amoxicillin/clavulanic acid in this clinical setting OBJECTIVE The purpose of this study was to assess presumptive sexually transmitted disease treatment on pregnancy outcome and HIV transmission . STUDY DESIGN In a r and omized trial in Rakai District , Ug and a , 2070 pregnant women received presumptive sexually transmitted disease treatment 1 time during pregnancy at varying gestations , and 1963 control mothers received iron/folate and referral for syphilis . Maternal-infant sexually transmitted disease/HIV and infant outcomes were assessed . Intent-to-treat analyses estimated adjusted rate ratios and 95 % confidence intervals . RESULTS Sexually transmitted diseases were reduced : Trichomonas vaginalis ( rate ratio , 0.28 ; 95 % CI , 0.18%-0.49 % ) , bacterial vaginosis ( rate ratio , 0.78 ; 95 % CI , 0.69 - 0.87 ) , Neisseria gonorrhoeae /Chlamydia trachomatis ( rate ratio , 0.43 ; 95 % CI , 0.27 - 0.68 ) , and infant ophthalmia ( rate ratio , 0.37 ; 95 % CI , 0.20 - 0.70 ) . There were reduced rates of neonatal death ( rate ratio , 0.83 ; 95 % CI , 0.71 - 0.97 ) , low birth weight ( rate ratio , 0.68 ; 95 % CI , 0.53 - 0.86 ) , and preterm delivery ( rate ratio , 0.77 ; 95 % CI , 0.56 - 1.05 ) ; but there were no effects on maternal HIV acquisition or perinatal HIV transmission . CONCLUSION Reductions of maternal sexually transmitted disease improved pregnancy outcome but not maternal HIV acquisition or perinatal HIV transmission In a prospect i ve study of colonization with group B streptococci ( GBS ) among 6,706 parturients , we found statistically increased incidences of premature rupture of membranes ( PROM ) and preterm delivery at less than 32 weeks ' gestation among women colonized with GBS . PROM occurred in 8.1 % of the total population but in 15.3 % of the colonized population ( p less than 0.005 ) . Preterm delivery at less than 32 weeks ' gestation occurred in 1.8 % of the total population but among 5.4 % of women colonized with GBS ( p less than 0.005 ) . The data suggest a causal relationship between GBS colonization and events leading to preterm birth . The possible impact of eradication of colonization with GBS on prematurity is considered OBJECTIVE Our purpose was to determine whether treatment of bacterial vaginosis with metronidazole in patients with preterm delivery in the penultimate pregnancy from preterm labor or premature rupture of membranes reduces the risk of subsequent preterm birth . STUDY DESIGN From January 1989 to June 1992 patients with a singleton gestation between 13 and 20 weeks and a history of preterm birth in the preceding pregnancy from either idiopathic preterm labor or premature rupture of membranes were screened for bacterial vaginosis . Those with a positive screen were r and omized to receive 250 mg of metronidazole three times a day for 7 days or placebo in a double-blind design . Data were analyzed with Student t and chi 2 tests , and differences considered significant at p < 0.05 . RESULTS Of 94 eligible patients , 80 were enrolled and completed the study , of which 44 received metronidazole . Both groups were comparable in number of entry variables . Compared with the placebo group , patients in the metronidazole group had significantly fewer hospital admissions for preterm labor , 12 ( 27 % ) versus 28 ( 78 % ) ; preterm births , eight ( 18 % ) versus 16 ( 39 % ) ; births of infants weighing < 2500 gm , six ( 14 % ) versus 12 ( 33 % ) ; and premature rupture of membranes , two ( 5 % ) versus 12 ( 33 % ) . CONCLUSION Treatment of bacterial vaginosis with metronidazole was effective in reducing preterm births in patients with a history of prematurity in the preceding pregnancy OBJECTIVE We hypothesized that upper genital tract microbial infection associated with spontaneous preterm birth may precede conception . Our objective was to estimate if antibiotic administration during the interpregnancy interval in nonpregnant women with a previous preterm birth before 34 weeks ' gestational age would reduce the rate of spontaneous preterm birth in the subsequent pregnancy . STUDY DESIGN Women with a spontaneous preterm birth < 34 weeks ' gestational age were r and omized at 4 months ' postpartum to receive oral azithromycin 1 g twice ( 4 days apart ) plus sustained-release metronidazole 750 mg daily for 7 days , or identical-appearing placebos . This regimen was repeated every 4 months until the subsequent pregnancy . RESULTS A total of 241 women were r and omized ; 124 conceived a subsequent pregnancy and were available for study , including 59 in the antibiotic group and 65 in the placebo group . In the antibiotic versus placebo group , neither subsequent spontaneous preterm birth ( < 37 weeks : 52 % vs 46 % , P = .568 ; < 35 weeks : 40 % vs 30 % , P = .276 ; < 32 weeks : 31 % vs 23 % , P = .376 ) nor miscarriage ( < 15 weeks : 12 % vs 14 % , P = .742 ) was significantly different . Although not statistically significant , mean delivery gestational age in the subsequent pregnancy was 2.4 weeks earlier in the antibiotic versus placebo group ( 32.0 + /- 7.9 vs 34.4 + /- 6.3 weeks , P = .082 ) , and mean birth weight was lower in the antibiotic group ( 2046 + /- 1209 vs 2464 + /- 1067 g , P = .060 ) . CONCLUSION Intermittent treatment with metronidazole plus azithromycin of nonpregnant women with a recent early spontaneous preterm birth does not significantly reduce subsequent preterm birth , and may be associated with a lower delivery gestational age and lower birth weight OBJECTIVE To examine the potential to reduce foetal and neonatal growth faltering through intermittent preventive treatment in pregnancy ( IPTp ) of malaria and reproductive tract infections with monthly sulphadoxine-pyrimethamine ( SP ) , alone or with two doses of azithromycin . METHODS We enrolled 1320 women with uncomplicated second trimester pregnancies into a r and omised , partially placebo controlled , outcome assessor-blinded clinical trial in Malawi . The participants received either two doses of SP ( control ) , SP monthly ( monthly SP ) or SP monthly and azithromycin ( 1 g ) twice ( AZI-SP ) . Newborn size was measured within two days of birth and infant growth at four weeks of age . RESULTS Babies in the AZI-SP group were on average ( 95 % CI ) 140 g ( 70 - 200 ) heavier at birth and 0.6 cm ( 0.2 - 0.9 ) longer at four weeks of age than control group babies . Corresponding differences between the monthly SP and control groups were 80 g ( 20 - 140 ) and 0.3 cm ( -0.0 to 0.6 ) . Compared with controls , babies in the AZI-SP group had a relative risk of 0.61 ( 0.40 - 0.93 ) for low birthweight , 0.60 ( 0.44 - 0.81 ) for stunting and 0.48 ( 0.29 - 0.79 ) for underweight at four weeks of age . Corresponding differences were similar but smaller between the monthly SP and control groups . CONCLUSIONS An IPTp regimen with monthly SP given to all pregnant women is likely to increase mean birthweight and length at four weeks of age in malaria holoendemic areas . Adding azithromycin to the regimen appears to offer further benefits in reducing foetal and neonatal growth faltering OBJECTIVE The purpose of this study was to evaluate the impact of an interconception antibiotic regimen on endometrial microbial flora and histologic type . STUDY DESIGN This was a secondary analysis of a double-blind r and omized placebo-controlled trial of prophylactic metronidazole plus azithromycin that was given to 241 women ( antibiotics , 118 women ; placebo , 123 women ) with a previous preterm delivery to prevent recurrent preterm delivery . Endometrial cultures and histologic types were obtained at r and omization and 2 weeks after treatment . The prevalence of either the new acquisition or the resolution of individual microbes , categories of microbes , and plasma cell endometritis were compared by chi-square or Fishers ' exact tests . RESULTS Overall , antibiotics were associated with lower acquisition and higher resolution of microbes . Of women without Gardnerella at baseline , 14 % of the women who received antibiotics vs 34 % of the women who received placebo had positive endometrial culture for the organism after treatment ( P < .05 ) ; of those women with G. vaginalis at baseline , 57 % of the women who received antibiotics vs 33 % of the women who received placebo ( P < .05 ) had a negative follow-up culture . Other gram-negative rods , especially aerobes in general , manifested similar patterns . The impact on anaerobes and plasma cell endometritis was not definitive , but there was a trend toward the increased resolution of the former ( 77 % vs 55 % ) and reduced acquisition of the latter ( 28 % vs 50 % ) . CONCLUSION The antibiotic regimen prevented the acquisition and promoted the resolution , but not the eradication , of gram-negative rods such as G. vaginalis and the aerobic subcategory OBJECTIVE Although an association between sub clinical intrauterine infection and preterm birth is well established , there is conflicting evidence regarding the benefits of antibiotic administration to women in preterm labor with intact membranes . We attempted to determine the effect of ampicillin-amoxicillin and erythromycin treatment on prolongation of pregnancy , the rate of preterm birth , and neonatal morbidity in patients with preterm labor and intact membranes . STUDY DESIGN A multicenter , r and omized , double-blinded , placebo-controlled trial was design ed and implemented by the Maternal-Fetal Medicine Units Network of the National Institute of Child Health and Human Development . Two hundred seventy-seven women with singleton pregnancies and preterm labor with intact membranes ( 24 to 34 weeks ) were r and omly allocated to receive either antibiotics or placebos . RESULTS Of the 2373 patients screened for participation in this study in six medical centers , 277 women were enrolled ( n = 133 for antibiotics group vs n = 144 for placebo group ) . In each study group , 60 % of patients completed all the study medications . The overall prevalence of microbial invasion of the amniotic cavity was 5.8 % ( 14/239 ) . No significant difference between the antibiotic group and the placebo group was found in maternal outcomes , including duration of r and omization-to-delivery interval , frequency of preterm delivery ( < 37 weeks ) , frequency of preterm premature rupture of membranes , clinical chorioamnionitis , endometritis , and number of subsequent admissions for preterm labor . Similarly , no significant difference in neonatal outcomes could be detected between the two groups including respiratory distress syndrome , bronchopulmonary dysplasia , intraventricular hemorrhage , sepsis , and admission and duration of newborn intensive special care unit hospitalization . CONCLUSION The results of this study do not support the routine use of antibiotic administration to women in preterm labor with intact membranes OBJECTIVE This study was undertaken to measure the impact of a single oral dose of cefetamet-pivoxil on pregnancy outcome in a population with substantial rates of low birth weight and high prevalence rates of maternal infections . STUDY DESIGN A total of 320 pregnant women with a poor obstetric history , defined as a history of low birth weight or stillbirth , were r and omized to receive a single oral dose of 2 gm of cefetamet-pivoxil or a placebo at a gestational age between 28 and 32 weeks . Patients were assessed at delivery and 1 week post partum for pregnancy outcome , postpartum endometritis , human immunodeficiency virus-1 and gonococcal infections . RESULTS A total of 253 ( 79 % ) women gave birth at the maternity hospital , of whom 210 ( 83 % ) attended the follow-up clinic . Overall , 18.1 % of these pregnant women were human immunodeficiency virus-1 seropositive , whereas 9.5 % had antibodies against Treponema pallidum . There was a significant difference between cefetamet-pivoxil- and placebo-treated women in infant birth weight ( 2927 gm vs 2772 gm , p = 0.03 ) and low birth weight ( < 2500 gm ) rates ( 18.7 % vs 32.8 % , p = 0.01 , odds ratio 2.1 , 95 % confidence interval 1.2 to 3.8 ) . The stillbirth rate was 2.2 % in the cefetamet-pivoxil group and 4.2 % in the placebo group ( not significant ) . Postpartum endometritis was found in 17.3 % in the intervention arm versus 31.6 % in the placebo group ( p = 0.03 , odds ratio 2.2 , 95 % confidence interval 1.1 to 7.6 ) . Neisseria gonorrhoeae was isolated from the cervix in 5 of 103 ( 4.9 % ) women in the intervention and in 14 of 101 ( 13.9 % ) in the placebo group ( p = 0.04 , odds ratio 3.2 , 95 % confidence interval 1.1 to 10.5 ) . CONCLUSION A single oral dose of cefetamet-pivoxil administered to pregnant women with a poor obstetric history seemed to improve pregnancy outcome in this population with high rates of maternal infections . Larger studies should be carried out to examine the public health impact , the feasibility , and the overall cost/benefit ratio of this intervention Objective : A multisite study was conducted in Africa to assess the efficacy of antibiotics to reduce mother-to-child transmission ( MTCT ) of HIV-1 . Design : A r and omized , double-blinded , placebo-controlled , phase III clinical trial . Methods : HIV-1-infected women were r and omly assigned at 20–24 weeks ' gestation to receive either antibiotics ( metronidazole plus erythromycin antenatally and metronidazole plus ampicillin intrapartum ) or placebo . Maternal study procedures were performed at 20–24 , 26–30 , and 36 weeks antenatally , and at labor/delivery . Infants were seen at birth , 4–6 weeks , and 3 , 6 , 9 and 12 months . The primary efficacy endpoints were overall infant HIV-1 infection and HIV-1-free survival at 4–6 weeks . All women and infants received single-dose nevirapine prophylaxis in this study . Results : A total of 1510 live-born infants were included in the primary analysis . The proportions of HIV-1-infected infants at birth were similar ( antibiotics 7.1 % ; placebo 8.3 % ; P = 0.41 ) . Likewise , there were no statistically significant differences at 4–6 weeks in the overall risk of MTCT of HIV-1 ( antibiotics 16.2 % ; placebo 15.8 % ; P = 0.89 ) or HIV-1-free survival ( 79.4 % in each study arm ) . Post-r and omization , the proportion of women with bacterial vaginosis at the second antenatal visit was significantly lower in the antibiotics arm compared with the placebo arm ( 23.8 versus 39.7 % ; P < 0.001 ) , but the frequency of histological chorioamnionitis was not different ( antibiotics 36.9 % ; placebo 39.7 % ; P = 0.30 ) . Adverse events in mothers and their infants did not differ by r and omization arm . Conclusion : This simple antepartum and peripartum antibiotic regimen did not reduce the risk of MTCT of HIV-1 Objective To test the hypothesis that prophylactic administration of clindamycin 2 % vaginal cream can reduce the incidence of preterm birth in a high risk population OBJECTIVE The use of antibiotics to prevent preterm birth has achieved mixed results . Our goal in this study was to determine if antibiotics given prenatally and during labor reduce the incidence of preterm birth and histologic chorioamnionitis . STUDY DESIGN A double-blind r and omized placebo-controlled trial of antibiotics to reduce preterm birth was conducted in 4 African sites . Both HIV-infected and uninfected pregnant women were given 2 courses of antibiotics , prenatally at 24 weeks ( metronidazole 250 mg and erythromycin 250 mg tid orally for 7 days ) , and during labor ( metronidazole 250 mg and ampicillin 500 mg q 4 hours ) or identically appearing placebos . Two thous and ninety-eight HIV-infected and 335 HIV-uninfected women had evaluable end points , including gestational age determined by both obstetric and pediatric criteria and birth weight ( BWT ) . Pre- and post-treatment rates of various sexually transmitted infections ( STI ) were determined and placentas were evaluated for histologic chorioamnionitis . RESULTS Comparing antibiotic versus placebo treated HIV-infected and uninfected women , there were few differences in mean gestational age at delivery , the percent of preterm births , the time between r and omization and delivery , or BWT . Four weeks after the 24-week antibiotic/placebo course , bacterial vaginosis , and trichomoniasis were reduced by 49 % to 61 % in the antibiotic groups compared with the placebo groups . However , in both the HIV-infected and uninfected groups , the placentas showed no difference in the rate of histologic chorioamnionitis . There were significant differences between HIV-infected and uninfected women , with the former having less education , a history of more stillbirths , more STIs , and in this pregnancy , a lower BWT ( 2949 vs 3100 g , P < .0001 ) . CONCLUSION Despite reducing the rate of vaginal infections , the antibiotic regimen used in this study did not reduce the rate of preterm birth , increase the time to delivery , or increase BWT . Failure of this regimen to reduce the rate of histologic chorioamnionitis may explain the reason the antibiotics failed to reduce preterm birth OBJECTIVE We assessed the effect of prenatal and peripartum antibiotics on maternal morbidity and mortality among HIV-infected and uninfected women . METHODS A multicenter trial was conducted at clinical sites in 4 Sub-Saharan African cities : Blantyre and Lilongwe , Malawi ; Dar es Salaam , Tanzania ; and Lusaka , Zambia . A total of 1558 HIV-infected and 271 uninfected pregnant women who were eligible to receive both the prenatal and peripartum antibiotic/placebo regimens were enrolled . Pregnant women were interviewed at 20 - 24 weeks of gestation and a physical examination was performed . Women were r and omized to receive either antibiotics or placebo . At the 26 - 30 week visit , participants were given antibiotics or placebo to be taken every 4 hours beginning at the onset of labor and continuing after delivery 3 times a day until a 1-week course was completed . Logistic regression and Cox proportional hazards models were used . RESULTS There were no significant differences between the antibiotic and placebo groups for medical conditions , obstetric complications , physical examination findings , puerperal sepsis , and death in either the HIV-infected or the uninfected cohort . CONCLUSION Administration of study antibiotics during pregnancy had no effect on maternal morbidity and mortality among HIV-infected and uninfected pregnant women A r and omized clinical trial was conducted to test the postulate that erythromycin treatment of pregnant mothers may prevent preterm deliveries and low birth weight ( LBW ) in India . Vaginal swabs ( for Ureaplasma urealyticum and Mycoplasma hominis cultures ) and endocervical specimens ( for Chlamydia trachomatis antigen testing ) were obtained from 437 pregnant women : 219 for the erythromycin group and 218 for the placebo group . Findings of the study showed that mean birth weight and the incidence of LBW and preterm deliveries in both groups were similar . This result is in opposition with the existing body of evidence that reports that infections in the genital tract caused by U. urealyticum and C. trachomatis may be associated with LBW and prematurity . The study therefore concludes that erythromycin treatment of pregnant women neither decreases the incidence of LBW or preterm deliveries nor will it improve birth weight of infants OBJECTIVE The purpose of this study was to explore whether endometrial microbial colonization and plasma cell endometritis are risk factors for adverse pregnancy outcomes , and whether these outcomes are influenced by interactions between interconceptional antibiotics and the micro-flora . STUDY DESIGN Subgroup analyses of data from a double-blind , r and omized , placebo-controlled trial of a course of metronidazole plus azithromycin given every 4 months to women with a prior preterm delivery to prevent recurrent preterm delivery . Endometrial cultures and histology were obtained at r and omization and repeated 2 weeks after the first treatment . Fifty-nine on antibiotics versus 65 on placebo had pregnancy outcomes . Prevalence of adverse pregnancy outcomes ( pregnancy loss or preterm birth < 37 weeks ) was stratified by treatment group and endometrial characteristics . Subgroups were assessed and screened for potential interaction ( P values for significance set a priori at < .01 ) , prior to formal statistical testing for interaction ( P values < .05 ) . RESULTS The prevalence of adverse pregnancy outcome was 62.7 % in the presence of endometrial microbial colonization at baseline ( any microbe ) and 50 % in the absence of colonization ( RR = 1.25 ; 99 % CI 0.42 - 3.7 ) . Prevalence of adverse pregnancy outcomes was 61.9 % with plasma cell endometritis , and 70.8 % without ; RR = 0.87 ( 0.50 - 1.5 ) . There was a nonsignificant reduction in adverse pregnancy outcome in the absence of Gardnerella vaginalis or gram-negative rods with RR ( 95 % CI ) = 0.60 ( 0.3 - 1.2 ) and 0.66 ( 0.4 - 1.2 ) , respectively . In the presence of these microbes , antibiotics appeared to increase adverse outcomes : RR = 1.5 ( 1.1 - 2.0 ) and 1.5 ( 1.1 - 2.1 ) , respectively . This reversal of impact represents a crossover interaction . CONCLUSION Neither baseline endometrial microbial colonization nor plasma cell endometritis were risk factors for adverse pregnancy outcome . However , colonization with specific microbes interacted with antibiotics to increase adverse outcomes Abstract To ascertain the relation between mycoplasmas in the cervix and urine of pregnant women and the outcome of pregnancy , 485 patients were studied prospect ively in the prenatal clinic of the Boston City Hospital . T-strains were recovered from 384 women who gave birth to babies whose mean birth weight was 202 g ( 7.1 oz ) less than that of the babies of women from whom T-strains were not isolated ( p less than 0.003 ) . Mycoplasma hominis , which was often associated with T-strains in cultures of the urine and cervix , was less well linked with low birth weight ( p equal to 0.054 ) . The association of T-strains with low birth weight was not related to shortened gestational length . The presence of T-strains in the urine and cervix was independent of other risk factors for low birth weight . T-strains or M. hominis were not related to history of previous premature births , stillbirths or abortions or to the development of toxemia or third-trimester hemorrhage Preterm delivery , which is associated with infections during pregnancy , is common in sub-Saharan Africa . We enrolled 1,320 pregnant women into a r and omized , controlled trial in Malawi to study whether preterm delivery and low birth weight ( LBW ) incidence can be reduced by intermittent preventive treatment of maternal malaria and reproductive tract infections . The participants received either sulfadoxine-pyrimethamine ( SP ) twice ( controls ) , monthly SP , or monthly SP and two doses of azithromycin ( AZI-SP ) . The incidence of preterm delivery was 17.9 % in controls , 15.4 % in the monthly SP group ( P = 0.32 ) , and 11.8 % in AZI-SP group ( risk ratio = 0.66 , P = 0.01 ) . Compared with controls , those in AZI-SP group had a risk ratio of 0.61 ( P = 0.02 ) for LBW . Incidence of serious adverse events was low in all groups . In conclusion , the incidence of preterm delivery and LBW can in some conditions be reduced by treating pregnant women with monthly SP and two azithromycin doses BACKGROUND : Infants born to women who receive intrapartum antibiotics may have higher rates of infectious morbidity and mortality than unexposed infants . OBJECTIVE : Our goal was to determine the association of maternal intrapartum antibiotics and early neonatal morbidity and mortality . METHODS : We performed secondary analysis of data from a multisite r and omized , placebo-controlled clinical trial of antibiotics to prevent chorioamnionitis-associated mother-to-child transmission of HIV-1 and preterm birth in sub-Saharan Africa . Early neonatal morbidity and mortality were analyzed . In an intention-to-treat ( ITT ) analysis , infants born to women r and omly assigned to antibiotics or placebo were compared . In addition , non-ITT analysis was performed because some women received non study antibiotics for various clinical indications . RESULTS : Overall , 2659 pregnant women were r and omly assigned . Of these , 2466 HIV-1–infected and HIV-1–uninfected women delivered 2413 live born and 84 stillborn infants . In the ITT analysis , there were no significant associations between exposure to antibiotics and early neonatal outcomes . Non-ITT analyses showed more illness at birth ( 11.2 % vs 8.6 % , P = .03 ) and more admissions to the special care infant unit ( 12.6 % vs 9.8 % , P = .04 ) among infants exposed to maternal intrapartum antibiotics than among unexposed infants . Additional analyses revealed greater early neonatal morbidity and mortality among infants of mothers who received non study antibiotics than of mothers who received study antibiotics . CONCLUSIONS : There is no association between intrapartum exposure to antibiotics and early neonatal morbidity or mortality . The associations observed in non-ITT analyses are most likely the result of women with peripartum illnesses being more likely to receive non study antibiotics We prospect ively studied the relationship of pregnancy outcome to bacterial vaginosis , an anaerobic vaginal condition , and to other selected genital pathogens among 534 gravid women . Bacterial vaginosis was presumptively diagnosed by gas-liquid chromatographic identification of microbial organic acid metabolites in 102 women ( 19 % ) , and cervical infection with Chlamydia trachomatis was found in 47 ( 9 % ) of the women . Although women with and without bacterial vaginosis had similar demographic and obstetric factors , neonates born to women with bacterial vaginosis had lower mean birth weight than did neonates born to women without bacterial vaginosis ( 2960 + /- 847 g vs 3184 + /- 758 g ) . Bacterial vaginosis was significantly associated with preterm premature rupture of the membranes ( odds ratio [ OR ] , 2.0 ; 95 % confidence interval [ Cl ] , 1.1 to 3.7 ) , preterm labor ( OR , 2.0 ; Cl , 1.1 to 3.5 ) , and amniotic fluid infection ( OR , 2.7 ; Cl , 1.1 to 6.1 ) , but not with birth weight below 2500 g ( OR , 1.5 ; Cl , 0.8 to 2.0 ) . Cervical infection with C trachomatis was independently associated with preterm premature rupture of the membranes , preterm labor , and low birth weight ( OR , 1.5 ; Cl , 0.8 to 2.0 ) OBJECTIVE In an effort to eluci date possible causes of preterm labor , we undertook a prospect i ve study of 50 patients consecutively admitted with intact membranes and preterm labor who eventually had a preterm delivery despite the use of tocolysis . STUDY DESIGN A comprehensive evaluation plan was instituted . This included a detailed history and physical examination , targeted ultrasonography , amniocentesis for Gram stain , culture , and glucose determination , laboratory analysis for infection ( complete blood cell count , urinalysis , and cervical and urine cultures ) and for antiphospholipid antibody syndrome ( antinuclear antibody , lupus anticoagulant , anticardiolipin antibody ) , pathologic examination of the placenta , and a urine toxicology screen . RESULTS The following groups of possible causes of preterm labor were identified : ( 1 ) faulty placentation , 50 % ( 25/50 ) ; ( 2 ) intrauterine infection 38 % ( 19/50 ) ; ( 3 ) immunologic factors , 30 % ( 15/50 ) ; ( 4 ) cervical incompetence , 16 % ( 8/50 ) ; ( 5 ) uterine factors , 14 % ( 7/50 ) ; ( 6 ) maternal factors 10 % ( 5/50 ) ; ( 7 ) trauma and surgery , 8 % ( 4/50 ) ; ( 8) fetal anomalies , 6 % ( 3/50 ) ; and ( 9 ) idiopathic conditions , 4 % ( 2/50 ) . Among the 50 patients two or more possible causes were identified in 58 % ( 29/50 ) . CONCLUSION We suggest that an exhaustive evaluation plan can identify possible causes in the majority ( 96 % ) of cases of " idiopathic " preterm labor that result in preterm delivery OBJECTIVE Histologic chorioamnionitis has been associated with preterm birth and low birthweight . Our goal was to evaluate the relationship between polymorphonuclear cell and mononuclear cell placental infiltrations and adverse infant outcomes . STUDY DESIGN Data from women who were enrolled in a trial of antibiotics for prevention of mother-to-child transmission of HIV-1 and of preterm birth were analyzed . Women who had HIV and women who did not have HIV were assigned r and omly to either metronidazole 250 mg and erythromycin 250 mg at 20 to 24 weeks of gestation 3 times daily for 7 days and metronidazole 250 mg and ampicillin 500 mg every 4 hours during labor or identical placebos . Women with HIV were offered nevirapine at delivery for the prevention of mother-to-child transmission . At delivery , various placental sites were evaluated for polymorphonuclear cell and mononuclear cell infiltration . RESULTS Polymorphonuclear and mononuclear cell infiltrations were common in the decidua ( 18 % and 43 % , respectively ) and chorioamnion ( 28 % and 34 % , respectively ) . Gestational age and birthweight were lower among women with polymorphonuclear cell infiltrations , with these relationships generally stronger at earlier gestational age and birthweight . Mononuclear infiltrations were not associated with adverse outcomes . Neither polymorphonuclear cell nor mononuclear placental infiltrations were associated with mother-to-child transmission of HIV . Antibiotic use was not associated with reduced polymorphonuclear or mononuclear cell infiltrations . CONCLUSION Polymorphonuclear cell infiltrations were associated with preterm birth and decreased birthweight and gestational age . Antibiotic use was not associated with reductions in polymorphonuclear or mononuclear cell infiltrations . In this nevirapine-treated population , neither polymorphonuclear nor mononuclear cell infiltration was associated with the mother-to-child transmission of HIV OBJECTIVE To estimate whether antibiotic treatment of asymptomatic women with a positive cervical or vaginal fetal fibronectin test in the second trimester would reduce the risk of spontaneous preterm delivery . METHODS Women were screened between 21 weeks 0 days and 25 weeks 6 days of gestation with cervical or vaginal swabs for fetal fibronectin . Women with a positive test ( 50 ng/mL or more ) were r and omized to receive metronidazole ( 250 mg orally three times per day ) and erythromycin ( 250 mg orally four times per day ) or identical placebo pills for 10 days . The primary outcome was spontaneous delivery before 37 weeks ' gestation after preterm labor or premature membrane rupture . RESULTS A total of 16,317 women were screened for fetal fibronectin , and 6.6 % had a positive test ; 715 fetal fibronectin test – positive women consented to r and omization . Outcome data were available for 703 women : 347 in the antibiotic group and 356 in the placebo group . The antibiotic and placebo groups were not significantly different for maternal age ( P = .051 ) , ethnicity ( P = .849 ) , marital status ( P = .127 ) , education ( P = .244 ) , and bacterial vaginosis ( P = .236 ) . No difference was observed in spontaneous preterm birth before 37 weeks ' ( odds ratio [ OR ] 1.17 , 95 % confidence interval [ CI ] 0.80 , 1.70 ) , less than 35 weeks ' ( OR 0.92 , 95 % CI 0.54 , 1.56 ) , or less than 32 weeks ' ( OR 1.94 , 95 % CI 0.83 , 4.52 ) gestation in antibiotic-compared with placebo-treated women . Among women with a prior spontaneous preterm delivery , the rate of repeat spontaneous preterm delivery at less than 37 weeks ' gestation was significantly higher in the active drug compared with the placebo group ( 46.7 % versus 23.9 % , P = .039 ) . CONCLUSION Treatment with metronidazole plus erythromycin of asymptomatic women with a positive cervical or vaginal fetal fibronectin test in the late second trimester does not decrease the incidence of spontaneous preterm delivery Sexually transmitted diseases ( STDs ) are highly prevalent in pregnant women in many developing countries and have been associated with poor obstetric outcomes . Case detection and treatment of STDs in women is problematic and expensive , underscoring the need for other strategies . To explore the potential benefits of routine antimicrobial therapy on pregnancy outcome , we carried out a r and omized , double-blind , clinical trial in one of the antenatal clinics in Nairobi , Kenya . Four hundred pregnant women between 28 and 32 weeks ' gestation were given a single dose of 250 mg ceftriaxone intramuscularly or a placebo . There was a significant difference between ceftriaxone and placebo-treated women in infant birth weight ( 3,209 versus 3,056 g , P = .01 ) . In addition , there was a trend toward lower rates of birth weight < 2,500 g ( 4.0 % versus 9.2 % , P = .08 ) and postpartum endometritis ( 3.8 % versus 10.4 % , P = .05 ) in the intervention than in the placebo group . Neisseria gonorrhoeae was isolated from the cervixes of postpartum women in 1.8 % of the intervention group as compared to 4.2 % of the control group . These data suggest a beneficial effect of antimicrobial prophylaxis on pregnancy outcome . Larger studies should be carried out to examine the public health impact of this intervention |
1,328 | 27,810,941 | These data permit the inferences that nutritional supplementation in the population s studied showed significant benefits in the healing of venous ulcers and tendency ( nonsignificant trends ) in the healing of diabetic and sickle cell ulcers | A systematic review and meta-analyses of nutritional supplementation to treat chronic lower extremity wounds was done in order to test the premise that impaired nutrition is implicated in healing . | Objective To estimate the prevalence of wounds managed by the UK 's National Health Service ( NHS ) in 2012/2013 and the annual levels of healthcare re source use attributable to their management and corresponding costs . Methods This was a retrospective cohort analysis of the records of patients in The Health Improvement Network ( THIN ) Data base . Records of 1000 adult patients who had a wound in 2012/2013 ( cases ) were r and omly selected and matched with 1000 patients with no history of a wound ( controls ) . Patients ’ characteristics , wound-related health outcomes and all healthcare re source use were quantified and the total NHS cost of patient management was estimated at 2013/2014 prices . Results Patients ’ mean age was 69.0 years and 45 % were male . 76 % of patients presented with a new wound in the study year and 61 % of wounds healed during the study year . Nutritional deficiency ( OR 0.53 ; p<0.001 ) and diabetes ( OR 0.65 ; p<0.001 ) were independent risk factors for non-healing . There were an estimated 2.2 million wounds managed by the NHS in 2012/2013 . Annual levels of re source use attributable to managing these wounds and associated comorbidities included 18.6 million practice nurse visits , 10.9 million community nurse visits , 7.7 million GP visits and 3.4 million hospital outpatient visits . The annual NHS cost of managing these wounds and associated comorbidities was £ 5.3 billion . This was reduced to between £ 5.1 and £ 4.5 billion after adjusting for comorbidities . Conclusions Real world evidence highlights wound management is predominantly a nurse-led discipline . Approximately 30 % of wounds lacked a differential diagnosis , indicative of practical difficulties experienced by non-specialist clinicians . Wounds impose a substantial health economic burden on the UK 's NHS , comparable to that of managing obesity ( £ 5.0 billion ) . Clinical and economic benefits could accrue from improved systems of care and an increased awareness of the impact that wounds impose on patients and the NHS Leg ulcers are a chronic manifestation of sickle-cell disease ( SCD ) and are often painful , disabling , and difficult to treat . RGD peptide matrix treatment is a novel therapy design ed to provide a topical synthetic extracellular matrix that can act as a temporary substitute for the damaged natural matrix at the ulcer site . In this r and omized , placebo-controlled , double-blind , prospect i ve , multicenter investigation , SCD patients with full-thickness leg ulcers were treated with st and ard therapy plus RGD peptide matrix or saline placebo once weekly for up to 10 weeks . Healing in patients with chronic ulcers ( 2 months or greater in duration ) was significantly accelerated ( P = .0085 ) in RGD peptide matrix recipients compared with the placebo group . In these chronic ulcer cases , the average percent ulcer closure ( decrease in ulcer surface area ) in the RGD peptide matrix group ( 54.4 % + /- 8.9 % ) exceeded that in the placebo group ( 19.0 % + /- 24.3 % ) nearly threefold by study endpoint . Furthermore , RGD peptide matrix was equally effective in promoting healing of long persistent ulcers and ulcers of shorter duration . In contrast , st and ard therapy plus placebo was significantly less effective ( P = .001 ) in promoting healing for ulcers of progressively greater duration . The results of this study provide preliminary evidence that RGD peptide matrix treatment may significantly accelerate healing of chronic sickle-cell leg ulcers OBJECTIVE Comparison of desloughing efficacy after four weeks and healing outcomes after 12 weeks in sloughy venous leg ulcers treated with Manuka honey ( Woundcare 18 + ) vs. st and ard hydrogel therapy ( IntraSite Gel ) . BACKGROUND Expert opinion suggests that Manuka honey is effective as a desloughing agent but clinical evidence in the form of a r and omised controlled trial is not available . There is a paucity of research which uses Manuka honey in venous ulcers . DESIGN Prospect i ve , multicentre , open label r and omised controlled trial . METHOD R and omisation was via remote telephone . One hundred and eight patients with venous leg ulcers having > or=50 % wound area covered in slough , not taking antibiotics or immunosuppressant therapy were recruited from vascular centres , acute and community care hospitals and leg ulcer clinics . The efficacy of WoundCare 18 + to deslough the wounds after four weeks and its impact on healing after 12 weeks when compared with IntraSite Gel control was determined . Treatment was applied weekly for four weeks and follow-up was made at week 12 . RESULTS At week 4 , mean % reduction in slough was 67 % WoundCare 18 + vs. 52.9 % IntraSite Gel ( p = 0.054 ) . Mean wound area covered in slough reduced to 29 % and 43 % , respectively ( p = 0.065 ) . Median reduction in wound size was 34 % vs. 13 % ( p = 0.001 ) . At 12 weeks , 44 % vs. 33 % healed ( p = 0.037 ) . Wounds having > 50 % reduction in slough had greater probability of healing at week 12 ( 95 % confidence interval 1.12 , 9.7 ; risk ratio 3.3 ; p = 0.029 ) . Infection developed in 6 of the WoundCare 18 + group vs. 12 in the IntraSite Gel group . CONCLUSION The WoundCare 18 + group had increased incidence of healing , effective desloughing and a lower incidence of infection than the control . Manuka honey has therapeutic value and further research is required to examine its use in other wound aetiologies . RELEVANCE TO CLINICAL PRACTICE This study confirms that Manuka honey may be considered by clinicians for use in sloughy venous ulcers . Additionally , effective desloughing significantly improves healing outcomes Summary .— The results of a double‐blind trial of zinc sulphate in patients with chronic venous leg ulceration are reported . No significantly increased rate of healing was observed in the zinc‐treated group In order to assess the reported efficacy of natural honey in the healing of chronic ulcers , the efficacy of locally applied natural honey was compared to that of Eusol solution in an open trial involving 20 patients with sickle cell anaemia ( SS ) who were in steady clinical states and had chronic leg ulceration . All patients were admitted to hospital for the 4 week duration of the trial for bed rest , daily aseptic dressings , and weekly measurement of the size of the ulcer . Fifteen patients with a total of 19 leg ulcers were evaluable at the end of the trial . Eleven ulcers were dressed with honey while 8 were dressed with Eusol . No significant differences were found in rates of healing of the ulcers in either treatment groups . This trial does not support the suggestion that natural honey is superior to Eusol in the healing of chronic sickle cell leg ulceration A double-blind , placebo-controlled study was carried out in 12 patients suffering from chronic venous insufficiency and persistent leg ulcers to assess the efficacy of pentoxifylline treatment as an adjunct to compression b and aging in the conservative management of venous leg ulcers . Six patients were allocated at r and om to receive twice-daily infusions of 200 mg pentoxifylline intravenously and 400 mg pentoxifylline orally 3-times daily for 7 days then 400 mg oral doses 3-times daily for a further 60 days . The control group received matching placebo in an identical regimen . Treatment outcome was assessed by changes between the start and end of the study in venous ulcer surface area , and continuous wave Doppler ultrasound was used to monitor ankle/arm systolic pressure ratio , venous pressure at the ankle , valvular competence and possible venous reflux at intervals throughout the study period . The results showed that in the patients treated with pentoxifylline complete ulcer healing took place in 4 out of 6 and there was a significant reduction in mean ulcer surface area . In the control group , complete ulcer healing was recorded in 1 out of 6 patient only and the ulcer area was only moderately reduced in the others . There was no statistically significant differences between the two groups in the variables monitored by Doppler ultrasound but the difference between treatment outcome was significant . Treatment was well-tolerated Abstract Objective : To determine whether pentoxifylline 400 mg ( Trental 400 ) taken orally three times daily , in addition to ambulatory compression b and ages and dressings , improves the healing rate of pure venous ulcers . Design : R and omised , double blind placebo controlled trial , parallel group study of factorial design , permitting the simultaneous evaluation of alternative pharmaceutical , b and aging , and dressings material s. Setting : Leg ulcer clinics of a teaching and a district general hospital in southern Scotl and . Participants : 200 patients with confirmed venous ulcers and in whom other major causal factors were excluded . Interventions : Pentoxifylline 400 mg three times daily or placebo . Main outcome measure : Complete healing ( full epithelialisation ) of all ulcers on the trial leg . Results : Complete healing occurred in 65 of the 101 ( 64 % ) patients receiving pentoxifylline and 52 of the 99 ( 53 % ) patients receiving placebo . Conclusions : The difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance . Key messages Leg ulcers cost the NHS around £ 400 million per annum 50%-75 % of venous leg ulcers can be succesfully treated with dressings and compression b and ages but take many months to heal A drug that reduced the healing time of venous ulcers would be useful , although no agent has been proved to be effective to date Trials with pentoxifylline , a vasoactive drug used in the treatment of peripheral vascular diseases , as an adjunct to the treatment of venous ulcers have been inconclusive At the 5 % level , pentoxifylline had a non-significant effect on healing rates of pure venous AIM Epidemiological data show that st and ard compression therapy for leg ulceration in chronic venous insufficiency ( CVI ) often fails to effectively improve patients ' condition . This study assesses the contribution of Daflon 500 mg added to conventional therapy in the healing of hypostatic ulcers of CVI patients . METHODS Patients of about 65 years were included , with ulcers > or = 2 and > or = 10 cm diameter on 1 or 2 limbs , Doppler ankle/arm pressure index > 0.9 , and no recent history of skin graft . Controls ( n=68 ) remained on compression alone while the tested group ( n=82 ) also received Daflon 500 mg 2 tablets/day during 6 months . Treatment could be stopped as soon as the reference ulcer appeared fully healed . Primary endpoints were the rate of healed ulcers and the time to complete healing assessed by planimetry/photography and clinical examination . Variations of the ulcer surface , appearance of the skin , and clinical symptoms of CVI were the secondary criteria . RESULTS Only 7 % of Daflon 500 mg patients necessitated the full 6 month therapy . Whatever the lesion size , from W8 significantly more healed ulcers were observed under Daflon 500 mg ( p=0.004 ) , and the ulcer surface was more reduced ( p=0.012 ) . For large ulcers , the rate of healing was approximately 2-fold higher with Daflon 500 mg , and the percentage of ulcers healed before W24 was significantly higher ( p=0.008 ) . Heavy leg sensation was significantly improved by Daflon 500 mg from W4 ( p < 0.05 ) . No treatment-related side effects were reported and the acceptability was considered excellent by 85 % of Daflon 500 mg patients . CONCLUSION Six months of Daflon 500 mg in addition to compression significantly improve some clinical symptoms and accelerate the healing process in patients with ulcerous complications of CVI , with a good acceptability We performed a r and omized , double‐blind study of the efficacy of locally applied zinc oxide on the healing of leg ulcers . Thirty‐seven geriatric patients , nineteen with arterial and eighteen with venous leg ulcers , were treated either with a gauze compress medicated with zinc oxide ( 400 μg ZnO/cm2 ) or with an identical compress without zinc oxide . The treatment was assessed from ulcer size measurements and the presence or abscncc of granulation and ulcer debridement over a period of 8 weeks . The zinc‐treated patients ( 83 % success rate ) responded significantly better ( P < 0·05 ) than the placebo‐treated patients ( 42 % success rate ) . The results suggest that healing of leg ulcers is improved after the addition of zinc oxide to the local regimen Several small studies have indicated that the systemic administration of pentoxifylline may accelerate healing of venous leg ulcers . The goal of this study was to further evaluate these findings in a larger scale placebo controlled trial and to explore the effect of the dose of pentoxifylline on healing . The study used a prospect i ve , r and omized , double-blind , parallel group placebo controlled design in a multicenter outpatient setting . Patients with one or more venous ulcer were enrolled , with all patients receiving st and ardized compression b and aging for treatment for their ulcers . Patients were also r and omized to receive either pentoxifylline 400 mg , pentoxifylline 800 mg ( two 400 mg tablets ) , or placebo tablets three times a day for up to 24 weeks . The main outcome measure was time to complete healing of all leg ulcers , using life table analysis . The study was completed as planned in 131 patients . Patients receiving 800 mg three times a day of pentoxifylline healed faster than placebo ( p = 0.043 , Wilcoxon test ) . The median time to complete healing was 100 , 83 , and 71 days for placebo , pentoxifylline 400 mg , and pentoxifylline 800 mg three times a day , respectively . Over half of all patients were ulcer free at week 16 ( placebo ) and at week 12 in both pentoxifylline groups . Whereas the placebo group had only achieved complete healing in half of the cases by week 16 , all of the subjects remaining in the group receiving the high dose of pentoxifylline had healed completely . Treatment with pentoxifylline was well tolerated with similar drop-out rates in all three treatment groups . Complete wound closure occurred at least 4 weeks earlier in the majority of patients treated with pentoxifylline by comparison to placebo . A higher dose of pentoxifylline ( 800 mg three times a day ) was more effective than the lower dose . We conclude that pentoxifylline is effective in accelerating healing of leg ulcers The objective of this study was to evaluate the efficacy of Daflon ® 500 mg ( Dios ) * in venous ulcers . A multicenter , double-blind , r and omized , controlled versus placebo ( Plac ) trial was conducted , with stratification according to the size of ulcer ( ≤ 10 cm and > 10 cm ) . The protocol called for a two-month treatment with Dios ( one tablet = 450 mg micronized purified Diosmin ) or a placebo , two tablets/day , in addition to compression therapy . Evaluations were performed every fifteen days , from DO to D60 . The primary endpoint , in accordance with Alex and er House group requirements were : percentage of patients with complete ulcer healing , ie , comparison between Dios and Plac group at D60 , and comparison of survival curves in each group between DO and D60 ( log rank test ) . Secondary endpoints included ulcer surface area assessed by computerized plani metric measurements , qualitative evaluation of ulcers , and symptoms . The patients were 105 men and women ranging in age from eighteen to eighty-five years , with st and ard compression stocking , who were undergoing st and ardized local care of ulcer and had no significant arterial disease ( ankle/arm systolic pressure index > 0.8 ) . Fifty-three patients received Dios , and 52 received Plac . The 2 groups were well matched for age ( m ±1 SD = seventy-one ±eleven years ) , gender , ulcer size , and associated disorders . Among patients with ulcer size ≤ 10 cm ( Dios = 44 , Plac = 47 ) a significantly larger number of patients had a complete ulcer healing at two months in the Dios group ( n = 14 ) in comparison with the Plac group ( n = 6 ) ( 32 % vs 13 % , P = 0.028 ) with a signifi cantly shorter time duration of healing ( P = 0.037 ) . No difference was shown for the secondary criteria , except for sensation of heavy legs ( P = 0.039 ) and a less atonic aspect of ulcer ( P = 0.030 ) in favor of Dios . Among the 14 patients with ulcer size > 10 cm ( Dios = 9 , Plac = 5 ) , subjected to a descriptive analysis only , no ulcer healed . This study showed that a two-month course of Daflon 500 mg at a daily dose of two tablets , in addition to conventional treatment , is of benefit in patients with venous ulcer ≤ 10 cm by accelerating complete healing OBJECTIVE To determine if oral nutritional supplementation improved wound healing in malnourished patients with diabetic foot ulcers when compared with a placebo . METHOD This prospect i ve r and omised controlled double-blind trial involved patients aged over 60 with diabetes mellitus and a Wagner grade I-II foot ulcer of over four weeks ' duration . Patients received either 400 ml ( 400 kcal ) oral nutritional supplementation ( n = 26 ) or 400 ml placebo ( n = 27 ) daily for six months . Patients were followed monthly for six months and after one and two years . RESULTS A third of the patients were classified as having protein-energy malnutrition at inclusion , with no difference between the two groups . Critical leg ischaemia was more common in the intervention group than in the placebo group ( p = 0.008 ) . Nine patients in the intervention group ( 35 % ) and four in the placebo group ( 15 % ) dropped out of the study ( not significant ) . Of those who completed the study , the wound had healed at six months in eight out of 23 patients ( 41 % ) ( placebo ) and in seven out of 17 ( 35 % ) ( intervention ) ( not significant ) . Twenty-four per cent of patients with protein-energy malnutrition at inclusion had healed at six months compared with 50 % of those without it ( not significant ) . CONCLUSION This is the first study to evaluate the possible benefits of nutritional supplementation on diabetic foot ulcers . A third of patients were malnourished . We encountered several method ological problems and were unable to demonstrate an improved wound healing rate in these patients OBJECTIVE To further study the clinical value of a herbal supplement in the treatment of chronic foot ulcers in diabetic patients . DESIGN Double-blind r and omised , placebo-control trial . SETTING Two general hospitals in Hong Kong . PATIENTS Eighty patients were recruited according to strict selection criteria . INTERVENTIONS Clinical measures included st and ard antidiabetic treatment , daily wound care including antiseptic bath , debridement , toe removal for gangrene when necessary , and the daily consumption of a herbal drink or placebo . MAIN OUTCOME MEASURES The primary outcome was limb salvage . Secondary outcomes included : granulation maturation , local temperature and circulatory changes , tumour necrosis factor-alpha levels , and adverse events . RESULTS Limb salvage was achieved in 85 % of the patients . Among the early failures , three each came from the treatment and placebo groups . After shifting to herbal treatment ( without unblinding of the original treatment ) , all were rescued in those initially assigned to herbal concoction ( 6 out of 6 ) while only 50 % ( 6 out of 12 ) were rescued from among those initially assigned to placebo . The speed of granulation maturation , and decline in tumour necrosis factor-alpha levels indicating control of inflammation , were also more favourable with the herbal group . No serious adverse events were observed . CONCLUSION The herbal adjuvant therapy was effective in helping the healing of chronic diabetic ulcers The aim of this study was the evaluation of treatment with pentoxifylline in patients with venous ulcers in a 6-month , r and omized , controlled trial . Treatment with placebo or pentoxifylline ( PXF ; 400 mg , 3 times daily ) lasted 6 months and was associated to elastic b and aging . The endpoints were the number of limbs with complete healing and the variation in the area of ulceration . A group of 172 patients were included : 82 in the PXF group and 88 in the placebo group ; 82 completed the study in the PXF group and 78 in the placebo group . Results . The two groups were comparable for age and sex distribution . The treatment was well tolerated . Complete healing was obtained in 67 % of patients in the PXF group and 30.7 % in the placebo group ( p<0.02 ) . The variations in the average area of ulceration were 86.7 % ( decrease ) in the PXF group and 47 % in the placebo group . The cost of treatment increased 21 % with PXF but the cost due to non-healing of the ulcer was equivalent to a 44 % increase ( in comparison with the PXF group ) . In conclusion PXF is effective and cost-effective in improving ulcer healing in patients with chronic venous hypertension OBJECTIVE --To determine the effect of oxpentifylline on the healing of venous ulcers of the leg . DESIGN --Double blind , r and omised , prospect i ve , placebo controlled , parallel group study . SETTING --Four outpatient clinics treating leg ulcers in Engl and and the Republic of Irel and . PATIENTS --80 Consecutive patients with clinical evidence of venous ulceration of the leg in whom appreciable arterial disease was excluded by the ratio of ankle to brachial systolic pressure being greater than 0.8 . INTERVENTIONS --All patients received either oxpentifylline 400 mg three times a day by mouth or a matching placebo for six months ( or until their reference ulcer healed if this occurred sooner ) in addition to a locally st and ardised method of compression b and aging . MAIN OUTCOME MEASURES --The primary end point was complete healing of the reference ulcer within six months . The secondary end point was the change in the area of the ulcer over the six month observation period . RESULTS --Complete healing of the reference ulcer occurred in 23 of the 38 patients treated with oxpentifylline and in 12 of the 42 patients treated with a placebo . Life table analysis showed that the proportion of ulcers healed at six months was 64 % in the group treated with oxpentifylline compared with 34 % in the group treated with a placebo ( log rank test chi 2 = 4.78 , p = 0.03 ) , which was significant ( odds ratio = 1.81 , 95 % confidence interval 1.20 to 2.71 ) . CONCLUSION --Oxpentifylline used in conjunction with compression b and aging improves the healing of venous ulcers of the leg The aim of the study was to test the efficacy and tolerability of pentoxifylline on the healing of venous ulcers in the absence of st and ard limb compression . The study used a prospect i ve r and omized , open , controlled , comparative , parallel group design . The study included 80 eligible patients with confirmed venous ulcers ( with clinical and photoplethysmography findings ) . The patients received either pentoxifylline 1200 mg per day ( 3 x 400 mg ) orally in addition of local therapy , or the same local therapy alone . The main outcome measures were complete healing of ulcers , change in the ulcer area over the six-month observation period , and tolerability of the drug . The results showed that complete healing occurred in 23 ( 57.5 % ) patients receiving pentoxifylline and 11 ( 27.5 % ) patients without pentoxifylline ( log rank test = 2.49 , p=0.013 ) . Unwanted effects of pentoxifylline occurred in 11/40 ( 27.5 % ) patients but were mild . Pentoxifylline is concluded to be efficacious in healing of venous ulcers in patients unable to tolerate compression therapy The results of a double‐blind study of zinc sulphate treatment in patients with venous leg ulceration are reported . No significantly increased rate of healing occurred in the zinc treated group . The serum zinc concentration at the onset of treatment did not significantly influence the rate of healing in zinc‐treated patients , but patients with an initial low serum zinc showed a more rapid rate of healing than those with a high zinc level irrespective of treatment . This finding could be accounted for by a defect of distribution of zinc in patients with venous leg ulceration Sickle cell leg ulcers are often debilitating , refractory to healing , and prone to recurrence . Healing of leg ulcers was incidentally observed during dose‐ranging trials of Arginine Butyrate in beta haemoglobinopathies . Here , a controlled Phase II trial was performed in sickle cell patients who had lower extremity ulcers refractory to st and ard care for at least 6 months . Patients were r and omized to receive st and ard local care alone ( Control Arm ) or st and ard care with Arginine Butyrate administered 5 d/week ( Treatment Arm ) , for 12 weeks . Ulcers were photographed weekly , traced , and ulcer areas were calculated by computerized planimetry and compared between the two study arms . Twenty‐seven study courses were evaluated . Control Arm subjects had 25 ulcers with a mean area of 25·7 cm2 initially and 23·2 cm2 after 12 weeks ; 2/25 ( 8 % ) healed completely . Treatment Arm subjects had 37 ulcers with a mean area of 50·6 cm2 initially and 28·3 cm2 at 12 weeks ; 11/37 of these ( 30 % ) healed completely . After 3 months , proportions of ulcers which healed were 6/25 ( 24 % ) and 29/37 ( 78 % ) , in the Control and Treatment Arms respectively ( P < 0·001 ) . These findings strongly suggest that Arginine Butyrate merits further evaluation for the treatment of refractory sickle cell leg ulcers in larger trials |
1,329 | 24,967,646 | Remarkably , no consistent indication of a negative effect of CO-PTSD on the reported SUD treatment outcome was found . | We investigated the role of comorbid posttraumatic stress disorder ( CO-PTSD ) in substance use disorder ( DSM-IV/ICD-10 substance abuse or dependence , SUD ) treatment . | OBJECTIVE This study examined 6-month treatment outcomes among 428 cocaine-dependent out patients with ( n = 34 ) and without ( n = 394 ) posttraumatic stress disorder ( PTSD ) in a r and omized controlled multisite clinical trial of manual-based psychotherapies for substance use disorder ( SUD ) . METHOD Assessment s were completed at baseline and monthly during the 6-month treatment . With longitudinal mixed-effects models , we compared outcomes between SUD-PTSD and SUD-only patients and also examined rates of within-group change . RESULTS Results indicated a highly consistent pattern : the SUD-PTSD patients were more impaired to begin with and remained so across time compared with SUD-only patients ( with the exception of substance use and addiction-related legal and employment problems , which did not differ between groups ) . Also , the SUD-PTSD patients improved less than SUD-only patients in alcohol use and the majority of addiction-related psychosocial problems . However , the two groups did not differ significantly in improvement over time on drug use or global psychological severity . CONCLUSIONS The greater impairment and relative lack of improvement of SUD-PTSD patients , compared with those with SUD-only , suggest a need for dual-diagnosis treatments that more directly target their areas of difficulty OBJECTIVE This study examined the prevalence of lifetime traumatic events and current symptoms of posttraumatic stress disorder ( PTSD ) among treatment-seeking cocaine-dependent out patients and compared patients with and without PTSD on current substance use , psychopathology , and sociodemographic characteristics . METHOD The subjects were 122 adult cocaine-dependent out patients participating in a treatment outcome study of psychosocial therapy . In addition to st and ard self-report and interview measures of psychopathology and substance use , the subjects completed the Trauma History Question naire and the PTSD Checklist before entering treatment . RESULTS These patients experienced a large number of lifetime traumatic events ( mean = 5.7 ) ; men experienced more general disasters and crime-related traumas than women , and women experienced more physical and sexual abuse than men . According to self-report measures , 20.5 % of the subjects currently met the DSM-III-R criteria for PTSD ; the rate of PTSD was 30.2 % among women and 15.2 % among men . Patients with PTSD had significantly higher rates of co-occurring axis I and axis II disorders , interpersonal problems , medical problems , resistance to treatment , and psychopathology symptoms than patients without PTSD . Psychopathology symptoms represented the most consistent difference between the two groups and provided the best prediction of PTSD status in a logistic regression . However , the groups did not differ significantly in current substance use or sociodemographic characteristics . CONCLUSIONS These findings underscore the value of screening substance abusers for PTSD , because it can identify a small but substantial number who might require additional treatment . Further studies of the relationship between PTSD and substance abuse appear warranted 424 BMJ | 24 FEBRUARY 2007 | VOLUME 334 Almost all studies have some missing observations . Yet textbooks and software commonly assume that data are complete , and the topic of how to h and le missing data is not often discussed outside statistics journals . There are many types of missing data and different reasons for data being missing . Both issues affect the analysis . Some examples are : ( 1 ) In a postal question naire survey not all the selected individuals respond ; ( 2 ) In a r and omised trial some patients are lost to follow-up before the end of the study ; ( 3 ) In a multicentre study some centres do not measure a particular variable ; ( 4 ) In a study in which patients are assessed frequently some data are missing at some time points for unknown reasons ; ( 5 ) Occasional data values for a variable are missing because some equipment failed ; ( 6 ) Some laboratory sample s are lost in transit or technically unsatisfactory ; ( 7 ) In a magnetic resonance imaging study some very obese patients are excluded as they are too large for the machine ; ( 8) In a study assessing quality of life some patients die during the follow-up period The present study evaluated whether Posttraumatic Stress Disorder ( PTSD ) symptom severity was associated with participation and treatment outcomes comparing a Vipassana meditation course to treatment as usual in an incarcerated sample . This study utilizes secondary data . The original study demonstrated that Vipassana meditation is associated with reductions in substance use . The present study found that PTSD symptom severity did not differ significantly between those who did and did not volunteer to take the course . Participation in the Vipassana course was associated with significantly greater reductions in substance use than treatment as usual , regardless of PTSD symptom severity levels . These results suggest that Vipassana meditation is worthy of further study for those with comorbid PTSD and substance use problems The present study investigates the prevalence of comorbid posttraumatic stress disorder ( PTSD ) in a sample of Polish alcohol dependent patients and examines the relationship between comorbid PTSD and alcohol use-related problems . Patients ( n=458 ) were recruited from r and omly chosen clinical setting s and were administered self-report measures of trauma exposure , PTSD symptomatology , and alcohol use-related problems . From this sample , 67 % of the patients reported having experienced at least one criterion A traumatic event , and 60 % of them reported multiple traumas . Approximately 25 % of them met the criteria for current PTSD . The only significant difference between the PTSD and non-PTSD groups was abuse/dependence of other psychoactive substances . However , patients reporting physical assaults committed by a non-stranger reported more frequent PTSD diagnosis , more extensive symptomatology , more conflicts with the law and more physical injuries due to drinking . The findings of the study confirm the importance of assessing trauma and PTSD in alcohol dependent patients Psychological trauma and post-traumatic stress disorder ( PTSD ) may complicate and reduce the effectiveness of treatment for substance use disorders ( SUDs ) . This study assessed trauma history and symptoms of simple and complex PTSD at baseline in a r and omized trial of contingency management ( CM ) compared to st and ard treatment ( ST ) with 142 cocaine- or heroin-dependent out patients . History of exposure to each of eight types of psychological trauma was unrelated to treatment outcome , except for witnessed assaults and emotional abuse . Complex PTSD symptoms were inversely associated with short-term treatment outcomes , and PTSD symptoms were positively related to long-term outcome , independent of the effects of demographics , psychological distress , baseline substance use status , and treatment modality . Complex PTSD symptoms warrant further study as a potential negative prognostic factor in SUD interventions AIMS To assess the utility of biological testing in a general population survey for estimating prevalence and evaluating self-report data quality . DESIGN An audio computer-assisted interview was administered to subjects from June 2001 to January 2002 . Immediately following the interview , subjects were requested to participate in hair , oral fluid and urine testing . SETTING Subjects were from r and omly selected households in the City of Chicago using multi-stage sampling methods . Interviews were conducted in subjects ' homes . PARTICIPANTS The data represent 627 r and omly selected adult participants , ages 18 - 40 years . MEASUREMENTS Prevalance , kappa , conditioned kappa , sensitivity , specificity , under-reporting , ' mixed model ' and logistic regression . FINDINGS Higher rates of marijuana use were generated from survey reports than from drug testing . Drug testing generated higher prevalence rates than survey reports for recent use of cocaine and heroin . Under-reporting of recent drug use was apparent for all three substances . Sensitivity was particularly low for cocaine and heroin . Race was related to under-reporting , with African Americans less likely to report marijuana use despite a positive test result . CONCLUSIONS The utility of drug testing for surveys depends on the type of substance examined as well as on the type of test employed . Multiple tests have more utility than a single test . Drug testing is useful for identifying the levels and sources of under-reporting in a survey and provides a basis for adjusting prevalence estimates based on self-reports This study examined concurrent and prospect i ve associations between substance use disorder ( SUD ) and posttraumatic stress disorder ( PTSD ) diagnosis and symptoms and mechanisms underlying these associations . Participants ( n = 133 ) were assessed at intake and 6 months following inpatient SUD treatment . Patients differed by baseline PTSD status on psychiatric comorbidity and substance use history but not on current substance use symptoms . Participants with alcohol use disorders reported a greater number of reexperiencing symptoms . Baseline PTSD status did not predict substance use outcome . However , change in PTSD status over follow-up predicted substance use outcomes ; those with unremitted PTSD demonstrated poorer SUD outcome than those with remitted PTSD . General psychiatric distress at follow-up was associated with poorer outcomes , and such distress mediated the association between PTSD change status and substance use outcome . Findings suggest that clinicians should assess for PTSD among those with SUD and , during treatment , should monitor PTSD and other psychological symptoms , which may be risk factors for relapse to substance abuse Objective To present lifetime rates of service use for psychological and substance use related problems among regular substance users and to examine factors associated with service use . Method Data come from a prospect ive-longitudinal , epidemiological study of a community sample of adolescents and young adults ( n = 2548 , age 14–24 years at baseline ) in Munich , Germany . The Munich-Composite International Diagnostic Interview ( M-CIDI ) was used at baseline and at two follow-ups to assess substance use and service use . Results Cumulated lifetime incidence of any substance abuse or dependence was 43.7 % . Of those with abuse and dependence 23 % had ever used any services for psychological or substance use related problems . Illicit substance users especially those with dependence had the highest rates of lifetime service use ( 52.1 % ) . Psychotherapists and counseling services were contacted most frequently among regular substance users over their lifetimes . Utlilisation rates of substance abuse services were low ( 2 % ) . Comorbid anxiety disorders and distressing life events were associated with increased lifetime service use . Conclusions Only a minority of adolescents and young adults with substance use disorders have ever sought professional help . Specialized substance abuse services play only a minor role . The core role of psychotherapists and non-substance abuse specialized services needs critical research attention . Linkages between psychotherapists and the substance use service system should be strengthened to detect and intervene at early developmental stages of abuse and dependence BACKGROUND Although disulfiram and naltrexone have been approved by the Food and Drug Administration for the treatment of alcoholism , the effect of these medications on alcohol use outcomes and on psychiatric symptoms is still unknown in patients with co-occurring disorders post-traumatic stress disorder ( PTSD ) . METHODS Patients ( n = 254 ) with a major Axis I psychiatric disorder and comorbid alcohol dependence were treated for 12 weeks in a medication study at three Veterans Administration outpatient clinics . R and omization included ( 1 ) open r and omization to disulfiram or no disulfiram ; and ( 2 ) double-blind r and omization to naltrexone or placebo . This result ed in four groups : ( 1 ) naltrexone alone ; ( 2 ) placebo alone ; ( 3 ) disulfiram and naltrexone ; or ( 4 ) disulfiram and placebo . Outcomes were measures of alcohol use , PTSD symptoms , alcohol craving , GGT levels and adverse events . RESULTS 93 individuals ( 36.6 % ) met DSM-IV criteria for PTSD . Subjects with PTSD had better alcohol outcomes with active medication ( naltrexone , disulfiram or the combination ) than they did on placebo ; overall psychiatric symptoms of PTSD improved . Individuals with PTSD were more likely to report some side effects when treated with the combination . CONCLUSIONS The results of this study suggest that disulfiram and naltrexone are effective and safe for individuals with PTSD and comorbid alcohol dependence OBJECTIVE The purpose of this study was to determine whether opioid-dependent patients with diagnosed posttraumatic stress disorder ( PTSD ) have poorer long-term outcomes in opioid substitution treatment than do patients without PTSD . METHOD This prospect i ve observational study examined outcomes of 255 opioid-dependent patients ( men = 248 ) entering opioid substitution treatment at eight clinics in the Veterans Health Administration ( VHA ) . Subjects were interviewed at treatment entry , 6 months , and 1 year about substance use and related problems , health status , treatment satisfaction , and non-VHA health care utilization . Medical records were review ed to obtain toxicology results , health care utilization data , and diagnoses . Medical record review identified a diagnosis of PTSD in 71 ( 28 % ) patients . Substance-use and mental-health outcomes and health care utilization in the first year following treatment entry were compared between patients with and without a diagnosis of PTSD . RESULTS Patients with and without PTSD had similar treatment responses . Although patients with PTSD had longer histories of drug use at intake , at 1-year follow-up they showed reductions in heroin , cocaine , and alcohol use , comparable to patients without the disorder . PTSD patients received higher doses of opiate medication , attended more psychosocial treatment sessions for substance-use disorder , and had better treatment retention . Psychiatric symptoms for patients with PTSD were more severe at intake and showed little improvement throughout treatment . CONCLUSIONS Opioid substitution therapy is as effective at reducing substance use in PTSD patients as it is in patients without the disorder , but additional services are needed for treatment of psychological problems that are largely unchanged by treatment for addiction This r and omized clinical trial retrospectively examined the effect of post-traumatic stress disorder ( PTSD ) and contingency management ( CM ) on cocaine use in opioid and cocaine dependent individuals maintained on high or low-dose LAAM r and omly assigned to CM or a yoked-control condition . Cocaine-positive urines decreased more rapidly over time in those without PTSD versus those with PTSD in the noncontingency condition . In participants with PTSD , CM result ed in fewer cocaine-positive urines compared to the noncontingent condition . This suggests that CM may help improve the potentially worse outcomes in opioid- and cocaine-dependent individuals with PTSD compared to those without PTSD . ( Am J Addict 2010;00:1 - 9 ) |
1,330 | 20,564,645 | During a 1.3-year time horizon , ESA was associated with higher costs and worse clinical outcomes .
Use of ESA for anemia related to cancer is associated with incremental cost-effectiveness ratios that are not economically attractive , even when used in a conservative fashion recommended by current guidelines | BACKGROUND Erythropoiesis-stimulating agents ( ESA ) administered to cancer patients with anemia reduce the need for blood transfusions and improve quality -of-life ( QOL ) .
Concerns about toxicity have led to more restrictive recommendations for ESA use ; however , the incremental costs and benefits of such a strategy are unknown . | Anemia , one of the most common complications of cancer chemotherapy , has been managed with red blood cell ( RBC ) transfusions . As an alternative , the agent epoetin alfa has the potential to reduce the transfusion requirements of patients receiving cancer chemotherapy . To estimate the value that cancer patients place on the drug , an economic analysis using the concept of willingness to pay ( WTP ) was conducted Health-related quality of life ( HrQOL ) assessment s are gaining importance as outcome measures in cancer clinical trials . A recently published clinical trial reported statistically significant ( P<0.001 ) increases in haemoglobin ( Hb ) levels and significantly ( P<0.01 ) increased HrQOL scores following the administration of recombinant human erythropoietin ( r-HuEPO , epoetin alfa ) versus placebo to anaemic cancer patients who received non-platinum chemotherapy . This study employed five cancer-specific HrQOL instruments . Hb and HrQOL data from this trial were analysed to estimate the minimally important difference ( MID ) in HrQOL measures that could be interpreted as clinical ly meaningful , with Hb level selected as the best external st and ard . Patients were assigned to two groups : improved ( Hb increases of > /=1 g/dL ) or stable ( change in Hb of-1 g/dL to < 1 g/dL ) . The MID was first determined as the difference between the mean changes in HrQOL in the improved group versus the stable group . By this analysis , the differences in HrQOL scores between the epoetin alfa group and the placebo group were clinical ly important for all Hb-sensitive , cancer-specific HrQOL evaluations . Linear regression analyses performed to provide estimates of the MID for specific values of Hb change confirmed that the differences in HrQOL scores between patient groups were clinical ly significant . These analyses were repeated using a data set from a separate clinical trial , which further supported the conclusion that observed HrQOL changes demonstrated in the multicentre , double-blind study were clinical ly important . These methods provide one means for interpreting the clinical relevance of changes in HrQOL evaluated in clinical trials PURPOSE To determine whether weekly epoetin alfa could improve hemoglobin ( HgB ) levels , reduce RBC transfusions , and improve quality of life ( QOL ) in patients with advanced cancer and with anemia after receiving myelosuppressive chemotherapy . PATIENTS AND METHODS This double-blind , placebo-controlled study r and omly assigned patients to placebo or epoetin alfa ( Ortho Biotech , Bridgewater , NJ ) 40,000 U subcutaneous weekly for 16 weeks . QOL , HgB , and RBC transfusions were measured pretreatment and monthly . RESULTS The study accrued 344 patients ; 330 were assessable for efficacy and 305 were assessable for QOL . Placebo-treated patients had a mean increase in HgB of 0.9 g/dL ( range , -3.8 to + 5.3 ) compared with 2.8 g/dL ( range , -2.2 to + 7.5 ) for epoetin-treated patients ( P < .0001 ) . During the study , 31.7 % of placebo-treated patients achieved a > or = 2 g/dL HgB increase compared with 72.7 % of epoetin-treated patients ( P < .0001 ) . The incidence of RBC transfusion for placebo and epoetin treatment arms was 39.6 % and 25.3 % ( P = .005 ) , respectively . The placebo group received 256 units of RBCs compared with 127 units in the epoetin group ( P < .0001 ) . The incidence of toxicity in the groups was similar . Changes in the average QOL scores from baseline to the end of the study were similar in the two groups ( P = not significant ) . The HgB responders ( irrespective of treatment arm ) had a mean change in Functional Assessment of Cancer Therapy ( FACT ) fatigue score from a baseline of + 5.1 compared with -2.1 for the nonresponders ( P = .006 ) . CONCLUSION Epoetin alfa significantly improved HgB and reduced transfusions in this patient population . These results support the use of weekly epoetin alfa as an ameliorative agent for cancer-related anemia PURPOSE The efficacy and safety of darbepoetin alpha ( DA ) for treating patients with active cancer and anemia not receiving or planning to receive cytotoxic chemotherapy or myelosuppressive radiotherapy was evaluated . PATIENTS AND METHODS Patients with active cancer and anemia not receiving or planning to receive chemotherapy or radiotherapy were enrolled onto a phase III , multicenter , r and omized , placebo-controlled study and administered placebo or DA 6.75 microg/kg every 4 weeks ( Q4W ) for up to 16 weeks with a 2-year follow-up for survival . Patients who completed 16 weeks of treatment could receive the same treatment as r and omized Q4W for an additional 16 weeks . The primary end point was all occurrences of transfusions from weeks 5 through 17 ; safety end points included incidence of adverse events and survival . RESULTS The incidence of transfusions between weeks 5 and 17 was lower in the DA group but was not statistically significantly different from that of placebo . DA was associated with an increased incidence of cardiovascular and thromboembolic events and more deaths during the initial 16-week treatment period . Long-term survival data demonstrated statistically significantly poorer survival in patients treated with DA versus placebo ( P = .022 ) . This effect varied by baseline covariates including , sex , tumor type , and geographic region ; statistical significance diminished ( P = .12 ) when the analysis was adjusted for baseline imbalances or known prognostic factors . CONCLUSION DA was not associated with a statistically significant reduction in transfusions . Shorter survival was observed in the DA arm ; thus , this study does not support the use of erythropoiesis-stimulating agents in this subset of patients with anemia of cancer PURPOSE To determine whether maintaining HGB levels > or = 12.0 g/dL with recombinant human erythropoietin ( R-HUEPO ) compared to " st and ard " treatment ( transfusion for HGB < or = 10.0 g/dL ) improves progression-free survival ( PFS ) , overall survival ( OS ) and local control ( LC ) in women receiving concurrent weekly cisplatin and radiation ( CT/RT ) for carcinoma of the cervix . In addition , to determine whether platinum-DNA adducts were associated with clinical characteristics or outcome . METHODS Patients with stage IIB-IVA cervical cancer and HGB < 14.0 g/dL were r and omly assigned to CT/RT+/-R-HUEPO ( 40,000 units s.c . weekly ) . R-HUEPO was stopped if HGB > 14.0 g/dL. Endpoints were PFS , OS and LC . Platinum-DNA adducts were quantified using immunocytochemistry assay in buccal cells . RESULTS Between 08/01 and 09/03 , 109 of 114 patients accrued were eligible . Fifty-two received CT/RT and 57 CT/RT+R-HUEPO . The study closed prematurely , with less than 25 % of the planned accrual , due to potential concerns for thromboembolic event ( TE ) with R-HUEPO . Median follow-up was 37 months ( range 9.8 - 50.4 months ) . PFS and OS at 3 years should be 65 % and 75 % for CT/RT and 58 % and 61 % for CT/RT+R-HUEPO , respectively . TE occurred in 4/52 receiving CT/RT and 11/57 with CT/RT+R-HUEPO , not all considered treatment related . No deaths occurred from TE . High-platinum adducts were associated with inferior PFS and LC . CONCLUSION TE is common in cervical cancer patients receiving CT/RT . Difference in TE rate between the two treatments was not statistically significant . The impact of maintaining HGB level > 12.0 g/dL on PFS , OS and LC remains undetermined Darbepoetin alfa is an erythropoiesis-stimulating agent ( ESA ) approved for treating chemotherapy-induced anemia . This phase II , double-blind , placebo-controlled study examined the efficacy of darbepoetin alfa for treating anemia of cancer ( AoC ) in patients not receiving chemotherapy or radiotherapy . Patients were r and omized 3:1 to receive darbepoetin alfa ( 6.75 microg/kg ) or placebo every 4 weeks ; the end of the study was at week 17 . The primary endpoint was the percentage of patients with a hematopoietic response . Secondary endpoints included transfusion incidence and safety parameters . Efficacy analyses were performed on 162 patients in the darbepoetin alfa group and 56 patients in the placebo group . The Kaplan-Meier percentages of patients who achieved a hematopoietic response ( darbepoetin alfa , 69 % ; placebo , 24 % ) or achieved the target hemoglobin ( darbepoetin alfa , 85 % ; placebo , 50 % ) differed significantly between treatment groups . The transfusion incidence did not differ between treatment groups probably because of the low baseline transfusion rates in AoC patients . The incidence of adverse events ( including on- study deaths ) was similar in both groups . In conclusion , darbepoetin alfa appeared to be well tolerated and significantly increased hemoglobin levels in these AoC study patients OBJECTIVES Mathematical modeling is used widely in economic evaluations of pharmaceuticals and other health-care technologies . Users of models in government and the private sector need to be able to evaluate the quality of models according to scientific criteria of good practice . This report describes the consensus of a task force convened to provide modelers with guidelines for conducting and reporting modeling studies . METHODS The task force was appointed with the advice and consent of the Board of Directors of ISPOR . Members were experienced developers or users of models , worked in academia and industry , and came from several countries in North America and Europe . The task force met on three occasions , conducted frequent correspondence and exchanges of drafts by electronic mail , and solicited comments on three drafts from a core group of external review ers and more broadly from the membership of ISPOR . RESULTS Criteria for assessing the quality of models fell into three areas : model structure , data used as inputs to models , and model validation . Several major themes cut across these areas . Models and their results should be represented as aids to decision making , not as statements of scientific fact ; therefore , it is inappropriate to dem and that models be vali date d prospect ively before use . However , model assumptions regarding causal structure and parameter estimates should be continually assessed against data , and models should be revised accordingly . Structural assumptions and parameter estimates should be reported clearly and explicitly , and opportunities for users to appreciate the conditional relationship between inputs and outputs should be provided through sensitivity analyses . CONCLUSIONS Model-based evaluations are a valuable re source for health-care decision makers . It is the responsibility of model developers to conduct modeling studies according to the best practicable st and ards of quality and to communicate results with adequate disclosure of assumptions and with the caveat that conclusions are conditional upon the assumptions and data on which the model is built Impaired cognition , fatigue , and diminished quality of life ( QOL ) are commonly associated with breast cancer chemotherapy . This r and omized , double-blind , placebo-controlled pilot trial assessed the feasibility of quantifying the effects of epoetin alfa on cognitive function and mood , and evaluated its effects on fatigue and QOL in patients with breast cancer treated with anthracycline-based adjuvant or neoadjuvant chemotherapy . Patients were r and omized to receive epoetin alfa 40,000 U subcutaneously once weekly or placebo at the beginning of 4 cycles of chemotherapy administered over 12 weeks . Cognitive function was assessed by Executive Interview ( EXIT25 ) and Clock Drawing Tasks ; mood by Profile of Mood States ; anemia-related symptoms , including fatigue , by the Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) subscale ; and QOL by Linear Analog Scale Assessment . Ninety-four patients were evaluable for efficacy and safety . Mean change in EXIT25 scores from baseline to cycle 4 in the epoetin alfa group was 1.3 + /- 3.3 ; the mean change was 0.3 + /- 2.4 in the placebo group ( a negative change indicates improved executive function ) . There was no difference between groups in mean change in EXIT25 score from baseline to 6-month follow-up assessment . Mean hemoglobin levels were higher in the epoetin alfa group compared with the placebo group after 4 cycles of chemotherapy . Epoetin alfa recipients had less of a decrease in FACT-An subscale scores from baseline to cycle 4 and improvement in FACT-An subscale scores at 6-month follow-up assessment compared with placebo . Epoetin alfa therapy was well tolerated . These data suggest that epoetin alfa may have attenuated the cognitive impairment and fatigue that occurred during adjuvant breast cancer chemotherapy This r and omized , controlled trial evaluated the effect of darbepoetin alfa on hospitalization days , transfusion requirements , hemoglobin levels , and fatigue in patients with anemia of cancer ( AOC ) . Eligible patients were anemic ( hemoglobin < or=11 g/dl ) due to cancer , > or=18 years old , and had not received chemotherapy or radiotherapy within 4 weeks of study screening . Patients were r and omized 4:1 to receive darbepoetin alfa , 3.0 microg/kg every 2 weeks ( Q2W ) ( n = 226 ) , or observation only for 12 weeks ( n = 59 ) , followed by an optional 9 weeks of darbepoetin alfa , 3.0 microg/kg Q2W . Endpoints were compared between the two treatment arms at week 13 . A planned interim analysis indicated that assumptions regarding hospitalization in the study design were incorrect , so the study was terminated early . Therefore , results for the primary endpoint should be interpreted cautiously . The hospitalization rate was similar ( 0.5 days ) for both the darbepoetin alfa and observation groups ( p = .73 ) . Transfusion incidence ( weeks 5 - 12 ) was significantly lower for darbepoetin alfa patients ( 8 % ) than for observation patients ( 22 % ) ( p = .0092 ) . By week 13 , hemoglobin increased by 2.1 g/dl in patients receiving darbepoetin alfa , compared with 0.1 g/dl in the observation group p < .0001 . Hemoglobin improvements were paralleled by an increase in Functional Assessment of Cancer Therapy-Fatigue score ( mean change in score at week 13 : darbepoetin alfa , 6.0 ; observation , 2.2 ; p < .05 ) . Darbepoetin alfa Q2W can significantly improve hemoglobin levels and reduce transfusion requirements in patients with AOC , result ing in significant improvements in health-related quality of life BACKGROUND Patients receiving chemotherapy often develop anemia . Darbepoetin alfa ( Aranesp(TM ) ) is an erythropoiesis-stimulating glycoprotein that has been shown , in dose-finding studies , to be safe and clinical ly active when administered to patients with cancer every 1 , 2 , or 3 weeks . This phase III study compared the safety and efficacy of darbepoetin alfa with placebo in patients with lung cancer receiving chemotherapy . METHODS In this multicenter , double-blind , placebo-controlled study , 320 anemic patients ( hemoglobin < or=11.0 g/dL ) were r and omly assigned to receive darbepoetin alfa or placebo injections weekly for 12 weeks . The 297 patients who completed at least the first 28 days of study were assessed for red blood cell transfusions , the primary endpoint . Patients were also assessed for hemoglobin concentration ( i.e. , hematopoietic response ) , adverse events , antibody formation to darbepoetin alfa , hospitalizations , Functional Assessment of Cancer Therapy (FACT)-Fatigue score , and disease outcome . Efficacy endpoints were assessed using Kaplan-Meier analyses , Cox proportional hazards analyses , and chi-square tests where appropriate . All statistical tests were two-sided . RESULTS Patients receiving darbepoetin alfa required fewer transfusions ( 27 % versus 52 % ; mean difference = 25 % ; 95 % confidence interval [ CI ] = 14 % to 36 % ; P<.001 ) , required fewer units of blood ( 0.67 versus 1.92 ; mean difference = 1.25 , 95 % CI = 0.65 to 1.84 ; P<.001 ) , had more hematopoietic responses ( 66 % versus 24 % ; mean difference = 42 % ; 95 % CI = 31 % to 53 % ; P<.001 ) , and had better improvement in FACT-Fatigue scores ( 56 % versus 44 % overall improvement ; 32 % versus 19 % with > or=25 % improvement ; mean difference = 13 % ; 95 % CI = 2 % to 23 % , P = .019 ) than patients receiving placebo . Patients receiving darbepoetin alfa did not appear to have any untoward effect in disease outcome and did not develop antibodies to the drug . Adverse events were similar between the groups . CONCLUSIONS Patients with chemotherapy-associated anemia can safely and effectively be treated with weekly darbepoetin alfa therapy . Darbepoetin alfa decreased blood transfusion requirements , increased hemoglobin concentration , and decreased fatigue . Although no conclusions can be drawn about survival from this study , the potential salutary effect on disease outcome warrants further investigation in a prospect ively design ed study PURPOSE This r and omized , double-blind , placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements , hematopoietic parameters , quality of life ( QOL ) , and safety in anemic cancer patients receiving nonplatinum chemotherapy . The study also explored a possible relationship between increased hemoglobin and survival . PATIENTS AND METHODS Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels < or = 10.5 g/dL , or greater than 10.5 g/dL but < or = 12.0 g/dL after a hemoglobin decrease of > or = 1.5 g/dL per cycle since starting chemotherapy , were r and omized 2:1 to epoetin alfa 150 to 300 IU/kg ( n = 251 ) or placebo ( n = 124 ) three times per week subcutaneously for 12 to 24 weeks . The primary end point was proportion of patients transfused ; secondary end points were change in hemoglobin and QOL . The protocol was amended before unblinding to prospect ively collect and assess survival data 12 months after the last patient completed the study . RESULTS Epoetin alfa , compared with placebo , significantly decreased transfusion requirements ( P = .0057 ) and increased hemoglobin ( P < .001 ) . Improvement of all primary cancer- and anemia-specific QOL domains , including energy level , ability to do daily activities , and fatigue , was significantly ( P < .01 ) greater for epoetin alfa versus placebo patients . Although the study was not powered for survival as an end point , Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa ( P = .13 , log-rank test ) , and Cox regression analysis showed an estimated hazards ratio of 1.309 ( P = .052 ) favoring epoetin alfa . Adverse events were comparable between groups . CONCLUSION Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy . Encouraging results regarding increased survival warrant another trial design ed to confirm these findings This work was conducted to evaluate the effect of early intervention with epoetin alfa ( EPO ) on transfusion requirements , hemoglobin level ( Hb ) , quality of life ( QOL ) and to explore a possible relationship between the use of EPO and survival , in patients with solid tumors receiving platinum-based chemotherapy . Three hundred and sixteen patients with Hb12.1g/dL were r and omised 2:1 to EPO 10000 IU thrice weekly subcutaneously ( n = 211 ) or best supportive care ( BSC ) ( n = 105 ) . The primary end point was proportion of patients transfused while secondary end points were changes in Hb and QOL . The protocol was amended before the first patient was recruited to also prospect ively collect survival data . EPO therapy significantly decreased transfusion requirements ( P < 0.001 ) and increased Hb ( P < 0.005 ) . EPO-treated patients had significantly improved QOL compared with BSC patients ( P < 0.05 ) . Kaplan-Meier estimates showed no differences in 12-month survival ( P = 0.39 ) , despite a significantly greater number of patients with metastatic disease in the EPO group ( 78 % vs. 61 % , P = 0.001 ) . EPO was well tolerated . This study has shown that early intervention with EPO can result in a significant reduction of transfusion requirements and increases in Hb and QOL in patients with mild anemia during platinum-based chemotherapy Objective To investigate the effect of recombinant human erythropoietin ( r-HuEPO ) administration on perioperative hemoglobin concentrations and on the number of blood transfusions in patients undergoing surgery for gastrointestinal tract malignancies . Summary Background Data Erythropoietin has been shown to improve the yield of autologously predonated blood and to reduce the subsequent requirements for homologous blood transfusions in cancer patients . Methods In this double-blind placebo-controlled study , 31 cancer patients received subcutaneous r-HuEPO in a dose of 300 IU/kg body weight plus 100 mg iron intravenously ( study group ) and 32 patients received placebo medication and iron ( control group ) . All patients received the medications daily for at least 7 days before and 7 days after the operation . Results Patients who received erythropoietin received significantly fewer transfusions intraoperatively and postoperatively . Postoperatively , the study group had significantly higher hematocrit , hemoglobin , and reticulocyte count values compared to the control group . The use of erythropoietin was also associated with a reduced number of postoperative complications and improved 1-year survival . Conclusions Patients with gastrointestinal tract cancer and mild anemia benefit from perioperative erythropoietin administration in terms of stimulated erythropoiesis , reduction in the number of blood transfusions , and a favorable outcome This r and omised controlled multicentre trial evaluated the effectiveness of recombinant human erythropoietin ( rhEPO ) in preventing anaemia and reducing the need for blood or erythrocyte transfusion in 122 ovarian cancer patients receiving platinum-based chemotherapy . The patients were r and omly allocated to receive rhEPO 150 U/kg or 300 U/kg subcutaneously , three times a week , or open control . Patients also received up to 6 cycles of carboplatin or cisplatin , alone or in combination with other cytotoxic agents . Intention-to-treat analysis showed that 39.4 % of patients in the control group received at least one blood transfusion , compared with 9.2 % of patients treated with rhEPO . Patients treated with rhEPO experienced a significantly longer time to first erythrocyte transfusion than the control group and were less likely to experience nadir haemoglobin levels < 10 g/dl ( P<0.001 and < 0.05 , respectively ) . A haemoglobin decrease < 1 g/dl during the first chemotherapy cycle , as well as a low baseline serum erythropoietin concentration , predicted a low transfusion need in rhEPO-treated patients but not in controls . During the study , 103 patients suffered at least one adverse event , but no serious , and only nine non-serious adverse events were considered possibly related to rhEPO therapy . These results indicate that treatment with rhEPO prevents anaemia , it reduces the need for blood or rhEPO erythrocyte transfusion in patients with ovarian cancer receiving platinum-based chemotherapy , and it is well tolerated . A starting dose of 150 U/kg of rhEPO , three times a week , may be recommended PURPOSE Previous trials have suggested a quality -of-life ( QOL ) improvement for anemic cancer patients treated with erythropoietin , but few used QOL as the primary outcome . We design ed a trial to investigate the effects of epoetin alfa therapy on the QOL of anemic patients with advanced non-small-cell carcinoma of the lung ( NSCLC ) . PATIENTS AND METHODS A multicenter , r and omized , double-blind , placebo-controlled trial was conducted . The proposed sample size was 300 patients . Eligible patients were required to have NSCLC unsuitable for curative therapy and baseline hemoglobin ( Hgb ) levels less than 121 g/L. Patients were assigned to 12 weekly injections of subcutaneous epoetin alpha or placebo , targeting Hgb levels between 120 and 140 g/L. The primary outcome was the difference in the change in Functional Assessment of Cancer Therapy-Anemia scores between baseline and 12 weeks . RESULTS Reports of thrombotic events in other epoetin trials prompted an unplanned safety analysis after 70 patients had been r and omly assigned ( 33 to the active arm and 37 to the placebo arm ) . This revealed a significant difference in the median survival in favor of the patients on the placebo arm of the trial ( 63 v 129 days ; hazard ratio , 1.84 ; P = .04 ) . The Steering Committee closed the trial . Patient numbers compromised the interpretation of the QOL analysis , but a positive Hgb response was noted with epoetin alfa treatment . CONCLUSION An unplanned safety analysis suggested decreased overall survival in patients with advanced NSCLC treated with epoetin alfa . Although infrequent , other similar reports highlight the need for ongoing trials evaluating erythropoietin receptor agonists to ensure that overall survival is monitored closely INTRODUCTION ADVANCED CANCER is frequently associated with significant anaemia which may be worsened by the administration of chemotherapy with myelotoxic agents such as methotrexate or nephrotoxic agents such as cisplatin . Although anaemia in cancer patients may be multifactorial in origin , it is often categorised as the anaemia of chronic disease ( ACD ) [ 1,2 ] . ACD is characterised by erythroid hypoplasia of the bone marrow , a modest decrease in red cell survival , decreased bone marrow reutilization of iron , and inappropriately low erythropoietin levels for the degree of anaemia [ 2 ] . Consistent with this A C D model , i napp rop r i a t e ly low se rum erythropoietin levels for the degree of anaemia have recently been documented in cancer patients [ 3 ] . The symptomato logy of anaemia may con t r ibu t e substantially to the overall lack of well-being that cancer patients frequently experience during their disease process . The t ransfusions often required for pal l ia t ion of these symptoms carry significant risks . There is an estimated 20 % probability of some associated adverse effect including fever , chills , rash , urticaria and exposure to hepatitis [ 4 ] . The scope of this problem is substantial when one considers that the annual transfusion estimate for this patient group in the U.S.A. alone is one million units of red blood cells/whole blood [ 5 ] . The observation that , at any given haemoglobin level , serum erythropoiet in levels tend to be lower in cancer patients than in iron deficiency patients [ 3 ] suggests that anaemia in cancer is at least partially due to a relative deficiency of e ry thropoie t in . In c o n j u n c t i o n with this observation , recent work demonstrating both the eft]caw and safety of recombinant human erythropoietin ( r-HuEPO ) in increasing haematocrit in anaemic patients with chronic renal failure [ 6,7 ] and in anaemic , zidovudine (AZT)-treated HIVinfected patients [ 8 ] offers the possibility that exogenous erythropoietin may also be an effective treatment for anaemia in cancer patients . To test this possibility , we conducted a series of double-blind , placebo-controlled trials using r-HuEPO in anaemic cancer patients in three different patient population s to examine the safety of r-HuEPO treatment , and its impact on haematocrit , t ransfusion requi rements and quality of life . The three populat ions were : pat ients receiving no chemotherapy , pa t i en t s rece iv ing cyclic n o n c i s p l a t i n c o n t a i n i n g chemothe rapy and pa t ients receiving cyclic c isp la t incontaining chemotherapy Patients with cervical cancer frequently suffer from anemia . This two-stage , adaptive- design study investigated the effect of anemia correction with epoetin beta on treatment outcomes . Patients with stage IIB – IVA cervical cancer received radiochemotherapy ( RCT ) and were r and omized to epoetin 150 IU/kg three times weekly ( n = 34 ) or st and ard care ( control ; n = 40 ) for up to 12 weeks . Primary end point for stage 1 aim ed to establish a correlation between anemia correction and treatment failure ( no complete response or relapsing within 6 months after RCT initiation ) as a proof of concept before moving into stage 2 . Secondary end points included progression/relapse-free survival , overall survival , response to RCT , hemoglobin ( Hb ) response , and safety . Median baseline Hb was 11.4 and 11.6 g/dL in epoetin and control groups , respectively . At treatment end point , median Hb increased by 1.3 g/dL with epoetin , but decreased by 0.7 g/dL in the control group ( P < 0.0001 ) . No significant correlation between Hb increase and treatment failure was demonstrated . There were no significant differences between epoetin and control groups in progression/relapse-free survival ( 29.4 % vs 32.5 % patients with events ; P = 0.96 ) , overall survival ( 23.5 % vs 12.5 % patients with events ; P = 0.22 ) or overall complete response ( 53 % vs 58 % ; P = 0.86 ) . Adverse events were well matched between groups . This study shows that epoetin beta rapidly , effectively , and safely increases Hb levels in patients with cervical cancer receiving RCT . No positive correlation of Hb increase and improvement in clinical outcomes could be demonstrated PURPOSE Epoetin alfa administered at 40,000 U once weekly ( qw ) to anemic cancer patients receiving chemotherapy increases hemoglobin levels , improves quality of life ( QOL ) , and reduces transfusions . The benefit of epoetin alfa in maintaining hemoglobin levels in cancer patients with hemoglobin less than 12 g/dL has not been evaluated . METHODS Breast cancer patients ( N = 354 ) receiving chemotherapy were r and omly assigned in 1:1 ratio to epoetin alfa ( 40,000 U qw ) or st and ard of care ( SOC ) . QOL was assessed at baseline and week 12 . Hemoglobin responses , transfusion requirements , and prognostic factors for responses were measured . RESULTS At week 12 , Functional Assessment of Cancer Therapy-Anemia ( FACT-An ; mean , 2.16 + /- 12.84 for epoetin alfa v -4.43 + /- 13.42 for SOC ) and FACT-An fatigue ( mean , 1.85 + /- 10.52 for epoetin alfa v -3.55 + /- 11.14 for SOC ) change scores were significantly higher in the epoetin alfa group ( P < .0001 ) . Hemoglobin responses defined as mean hemoglobin > or = 12 g/dL or a > or = 2 g/dL increase compared with baseline were significantly higher in the epoetin alfa group versus SOC : 52.0 % v 5.1 % and 65.7 % v 6.3 % , respectively ( P < .0001 for both comparisons ) . Percentage transfused was significantly lower in the epoetin alfa group compared with SOC ( 8.6 % v 22.9 % ) . More than 90 % of patients did not require a dose increase and 28.7 % had a dose reduction . CONCLUSION Epoetin alfa administered at 40,000 U qw is effective in improving QOL , maintaining hemoglobin level , and reducing transfusion requirements in breast cancer patients . The high effectiveness observed could be attributed in part to early treatment with epoetin alfa The objective of this study was to assess the cost-utility of renal transplantation compared with dialysis . To accomplish this , a prospect i ve cohort of pre-transplant patients were followed for up to two years after renal transplantation at three University-based Canadian hospitals . A total of 168 patients were followed for an average of 19.5 months after transplantation . Health-related quality of life was assessed using a hemodialysis question naire , a transplant question naire , the Sickness Impact Profile , and the Time Trade-Off Technique . Fully allocated costs were determined by prospect ively recording re source use in all patients . A societal perspective was taken . By six months after transplantation , the mean health-related quality of life scores of almost all measures had improved compared to pre-transplantation , and they stayed improved throughout the two years of follow up . The mean time trade-off score was 0.57 pre-transplant and 0.70 two years after transplantation . The proportion of individuals employed increased from 30 % before transplantation to 45 % two years after transplantation . Employment prior to transplantation [ relative risk ( RR ) = 23 ] , graft function ( RR 10 ) and age ( RR 1.6 for every decrease in age by one decade ) , independently predicted employment status after transplantation . The cost of pre-transplant care ( $ 66,782 Can 1994 ) and the cost of the first year after transplantation ( $ 66,290 ) were similar . Transplantation was considerably less expensive during the second year after transplantation ( $ 27,875 ) . Over the two years , transplantation was both more effective and less costly than dialysis . This was true for all subgroups of patients examined , including patients older than 60 and diabetics . We conclude that renal transplantation was more effective and less costly than dialysis in all subgroups of patients examined |
1,331 | 12,056,964 | There is good evidence that a continuous regimen of terbinafine ( 250 mg/d ) for 3 months is the most effective oral treatment for fungally infected toenails . | OBJECTIVE To identify and synthesize the evidence for the efficacy of oral treatments for fungal infections of the toenails . | BACKGROUND Onychomycosis is a prevalent infection of the nail caused primarily by dermatophytes . Fluconazole is active in vitro against the most common pathogens of onychomycosis , penetrates into the nail bed , and is clinical ly effective in the treatment of a wide variety of superficial fungal infections . OBJECTIVE The purpose of this study was to compare the efficacy and safety of three different doses of fluconazole ( 150 , 300 , and 450 mg ) given orally once weekly to that of placebo in the treatment of distal subungual onychomycosis of the toenail caused by dermatophytes . METHODS In this multicenter , double-blind study , 362 patients with mycologically confirmed onychomycosis were r and omized to treatment with fluconazole , 150 , 300 , or 450 mg once weekly , or placebo once weekly for a maximum of 12 months . To enter the study , patients were required to have at least 25 % involvement of the target nail with at least 2 mm of healthy nail from the nail fold to the proximal onychomycotic border . Patients who were clinical ly cured or improved at the end of treatment were further evaluated over a 6 month follow-up period . At both the end of therapy and the end of follow-up , clinical success of the target nail was defined as reduction of the affected area to less than 25 % or cure . RESULTS At the end of therapy , 86 % to 89 % of patients in the fluconazole treatment groups were judged clinical successes as defined above compared with 8 % of placebo-treated patients . Clinical cure ( completely healthy nail ) was achieved in 28 % to 36 % of fluconazole-treated patients compared with 3 % of placebo-treated patients . Fluconazole demonstrated mycologic eradication rates of 47 % to 62 % at the end of therapy compared with 14 % for placebo . The rates at the end of follow-up were very similar , indicating that eradication of the dermatophyte was maintained over the 6-month period . All efficacy measures for the fluconazole groups were significantly superior to placebo ( p=0.0001 ) ; there were no significant differences between the fluconazole groups on these efficacy measures . The clinical relapse rate among cured patients over 6 months of follow-up was low at 4 % . Fluconazole was well tolerated at all doses over the 12-month treatment period , with the incidence and severity of adverse events being similar between the fluconazole and placebo treatment groups . Mean time to clinical success in the fluconazole treatment groups was 6 to 7 months . This time frame may be used as a guideline for fluconazole treatment duration . CONCLUSION The results of this study support the use of fluconazole in the treatment of distal subungual onychomycosis of the toenail caused by dermatophytes . Doses between 150 to 450 mg weekly for 6 months were clinical ly and mycologically effective as well as safe and well tolerated In a multicentre , r and omised , double-blind , 48-week clinical trial , 118 patients with toe-nail onychomycosis were given terbinafine ( 250 mg daily ) or placebo for 12 weeks , followed by 12 weeks of observation . Non-responders were offered 12 further weeks of terbinafine ( 250 mg daily ) from week 28 . Each patient had 8 - 12 consecutive nail specimens collected from the same nail , allowing for an assessment of the fungal nail flora from 1,321 nail specimens . By week 48 , the overall mycological cure rate for terbinafine patients was 94 % . 64 % of patients had an underlying dermatophyte infection with at least 1 non-dermatophyte mould or yeast isolated from at least 1 specimen . These contaminants often overgrow or mask the presence of a dermatophyte . In only 2.5 % of all patients was the same non-dermatophyte isolated from 2 or more consecutive specimens , probably representing secondary colonisation which exploits nutrients released by the underlying dermatophyte . The presence of incidental non-dermatophyte contaminants or secondary colonisers did not affect treatment outcome , and in this study treatment of the primary dermatophyte pathogen with terbinafine cleared the nails from infection in all cases . 80 % of patients remained mycologically negative after 2 years BACKGROUND Current treatment of onychomycosis of the toenail is poor and relapse is common . OBJECTIVE Our purpose was to assess the efficacy and safety of oral terbinafine and placebo in onychomycosis of the toenail with the use of a novel treatment protocol . METHODS This was a r and omized , double-blind , 48-week study . Twelve weeks of terbinafine ( 250 mg daily ) or placebo was followed by 12 weeks of observation . Responders received no further treatment and nonresponders were offered 12 weeks of terbinafine ( 250 mg daily ) from week 28 . RESULTS Of 111 evaluable patients , 88 % ( 49 of 56 ) of the patients given terbinafine and 29 % ( 16 of 55 ) of the patients given placebo had a negative mycologic culture at week 24 ( p < 0.001 ) , 57 % ( 32 of 56 ) of the terbinafine group and 6 % ( 3 of 55 ) of the placebo group were responders ( p < 0.001 ) . By week 48 , after the terbinafine nonresponders were given a second 12-week course of terbinafine , the overall mycologic cure rate for the patients given terbinafine was 94 % . CONCLUSION High mycologic cure rates in onychomycosis of the toenail can be achieved by terbinafine by this novel treatment regimen BACKGROUND Griseofulvin has been used in the treatment of toenail onychomycosis with limited success . Evidence suggests that terbinafine may be more effective . OBJECTIVE In a double-blind , parallel-group study we compared 250 mg/day terbinafine for 16 weeks with 500 mg/day griseofulvin for 52 weeks ( or for shorter periods in cured patients ) in patients with toenail onychomycosis . METHODS Eighty-nine patients with culture-proved tinea unguium were included , and 43 in the terbinafine group and 41 in the griseofulvin group were assessable for efficacy . Patients who had not improved after 16 weeks were entered into an open study and were given 250 mg/day terbinafine for 16 weeks with the study code still blinded and were then followed up for 20 weeks . RESULTS Terbinafine was significantly more effective than griseofulvin , with 42 % being completely cured and 84 % mycologically cured compared with only 2 % with total cure and 45 % with mycologic cure in the griseofulvin-treated group . The number of side effects was significantly lower in the terbinafine group ( 11 % ) compared with the griseofulvin group ( 29 % ) . CONCLUSION Terbinafine is significantly more effective than griseofulvin in the treatment of toenail onychomycosis BACKGROUND Dermatophyte infections of the toenail have been difficult to treat , requiring long courses of therapy and having high recurrence rates . New oral antifungal agents with better outcomes and minimal adverse events are needed . OBJECTIVE The purpose of this study was to compare two newer antifungal compounds , terbinafine and itraconazole , for efficacy and safety in toenail onychomycosis caused by dermatophytes . METHODS The study was r and omized and double-blind . It compared 12 weeks of continuous oral treatment with terbinafine 250 mg/day or itraconazole 200 mg/day for confirmed toenail dermatophyte onychomycosis . Clinical symptoms and mycologic outcome were assessed at weeks 4 , 8 , 12 , 24 , 36 , and 48 . A total of 372 patients ( 186 in each group ) with dermatophyte infection confirmed by microscopy and culture were included in the intent-to-treat analysis . RESULTS At week 48 , a statistically significantly greater percentage of the terbinafine group than itraconazole group showed negative mycology ( 73 % [ 119 of 163 ] vs 45.8 % [ 77 of 168 ] ; p < 0.0001 ) ( difference = 27.2 % ; 95 % CI = [ 17.0 % , 37.3 % ] ) . The difference was also confirmed clinical ly ( p = 0.001 ) in the patients who were clinical ly cured or had only minimal symptoms at the end of the study ( 76.2 % [ 125 of 164 ] vs 58.1 % [ 100 of 172 ] ) ( difference = 18.1 % ; 95 % CI = [ 8.24 % , 27.9 % ] ) . The geometric mean length of healthy nail of the big toe was significantly greater in the terbinafine than itraconazole group ( 8.1 vs 6.4 mm ; p = 0.026 ) . Tolerability was good to very good in almost 90 % of patients in both groups , and all reported adverse events were known for these compounds . CONCLUSION Terbinafine produced higher rates of clinical and mycologic cure at follow-up than did itraconazole Toenail tinea is a very recalcitrant dermatosis . Griseofulvin at > or = 500 mg/day is the current medication of choice , but it is minimally successful . In a controlled open trial ultramicrosize griseofulvin ( UMSG ) at doses of 660 and 990 mg/day was compared with itraconazole at 100 mg/day in 109 patients . At 4-week intervals , the patients were evaluated for their clinical and mycological statuses and adverse reactions . Treatment was given for up to 18 months . Compliance was checked by tablet counting . Response ( cure , partial cure , marked improvement ) was analyzed by the intent-to-treat method . Cured and partially cured patients were followed up . Except for one early dropout , the toenails ( mean , 6 to 7 ) were involved . Cure or partial cure was found in 6 % ( UMSG at 660 mg ) , 14 % ( UMSG at 990 mg ) , and 19 % ( itraconazole at 100 mg ) of patients ( P = 0.2097 ) ; marked improvement was found in 36 , 44 , and 39 % of patients in the three treatment groups , respectively . Most patients had to be treated for 18 months . Failure was related to short medication periods ( adverse drug reactions , dropout ) . While stable cure was not obtained with UMSG at 660 mg , the higher dose of UMSG and itraconazole gave stable cures in the other patients . Side effects of nausea , diarrhea , and headache were found in 20 , 26 , and 11 patients , respectively ( P = 0.0028 ) , and the numbers in whom medication had to be discontinued differed , too ( P = 0.0137 ) . While there was no major difference with glutamic-pyruvic transaminase and gamma-GT , total and low-density lipoprotein cholesterol levels declined slightly in the itraconazole group ( P = 0.0357 and P = 0.0639 , respectively , at 3 months ) . More than 70 % of the patients had an average compliance of > or = 90 % ; four patients ( two dropouts ) were poor compliers . In conclusion , it appears question able whether griseofulvin can continue to be considered the " gold st and ard " in the treatment of toenail tinea . At present , itraconazole at 100 mg shows better efficacy and is better tolerated Lamisil ® ( terbinafine ) 250 mg daily and itraconazole 200 mg daily were compared in the treatment of dermalophyte toe onychomycosis over 12 weeks in a double‐blind r and omized clinical trial . At the end of follow‐up ( week 48 ) treatment with Lamisil ® led to negative mycology in 7 3 % of patients compared with 45–8 % in the itraconazole group ( P < 00001 ) , Globally the clinical symptoms of the target nail improved , a response which was in favour of Lamisil ® ( P=0·001 ) , The percentages of patients who were clinical ly totally cured or who presented with only minimal symptoms were 76′3 ' ) ( ) for the Lamisil ® ‐treated group compared with 58–1 % in the itraconazole group . The unaffected nail length for big toes was significantly higher in the Lamisil ® ‐treated group ( 9·1 mm vs , 7·7 mm ; P= 0·0298 ) . Onycholysis was also less in the Lamisil ® group ( P = 0·001 ) . We conclude that 12 weeks ” conlinitous oral therapy leads to higher cure rates with Lamisil ® than with itraconazole and that both drugs are equally well tolerated Terbinafine ( Lamisil ) has been registered throughout the world for the treatment of finger and toenail onychomycosis . The recommended duration of treatment of toenail onychomycosis based on phase III studies is 12 weeks . This study was design ed to determine : ( i ) if patients in whom the proximal part of the toenails was not affected respond as well after 6 weeks treatment as after 12 weeks treatment ; ( ii ) to identify factors which may allow selection of patients for shorter treatment duration ; and ( iii ) confirm that 6 weeks therapy is sufficient in fingernail mycosis . One hundred and forty‐eight patients received 250 mg terbinafine daily for either 6 or 12 weeks in a double‐ blinded manner , and were followed until 48 weeks after start of therapy . Cure of the nail infection was defined as negative mycological tests ( mycological cure ) and progressive growth of normal nail ( clinical cure ) . Mycological cure was recorded in 43 of 72 ( 59.7 % ) in the 6‐week group and 55 of 76 ( 72.4 % ) in the 12‐week group . In those who completed the study per protocol in the 6‐week group . 34 of 61 ( 55.7 % ) were cured mycologically corresponding to 46 of 56 ( 82.1 % ) in the 12‐week group . The overall clinical and mycological cure rates for the two groups were 28 of 61 ( 45.9 % ) and 33 of 56 ( 58.9 % ) , respectively . In the small number of patients with associated fingernail infection , all were improved and six of eight ( 75.0 % ) were cured after a duration of treatment of 6 weeks . A priori risk factors for failure of cure could not be identified in either group . However , shorter duration of disease prior to treatment and no involvement of the big toenail was associated with a trend toward better responses in both groups . It can be concluded from this study that , in toenail mycosis without visible matrix involvement , 6 weeks treatment of terbinafine is generally not sufficient , whereas fingernail infections respond well to this short therapy Sixty-one patients with a clinical diagnosis of onychomycosis in finger or toe nails were treated with itraconazole 100 mg/day or griseofulvin 500 mg/day for six to nine months . The infective causes were Trichophyton rubrum , Trichophyton mentagrophytes , or Trichophyton violaceum , and in two cases C and ida albicans . A total of 27 finger and 390 toe nails were infected . Statistically significant intragroup reductions from baseline symptom severity values were seen at endpoint ( month 6 or 9 ) for both treatment groups for all parameters : colour change , thickness , brittleness and unaffected area . No clinical ly or statistically significant differences between the treatment groups were seen at endpoint . However , the itraconazole group continued to improve during the follow-up , while the mean symptom severity ratings remained the same in the griseofulvin group . All itraconazole patients and 85 % of griseofulvin patients were rated as cured or markedly improved at endpoint . Nineteen out of 26 evaluable itraconazole patients ( 73 % ) remained cured during the three month follow-up period , compared with 12 out of 17 griseofulvin patients ( 71 % ) . The rather large number of drop-outs , especially among griseofulvin patients , makes it difficult to draw definitive conclusions of the symptom recurrence . Two itraconazole patients stopped medication due to an adverse event , compared to four patients in the griseofulvin group . The clinical laboratory data on itraconazole-treated patients did not show any statistically or clinical ly significant changes . In conclusion , itraconazole was at least as effective as griseofulvin in the treatment of onychomycosis . The itraconazole group continued to improve after the treatment was stopped . The results show that itraconazole 100 mg/day is safe and efficient in the long-term treatment of fungal nail infections BACKGROUND terbinafine persists in the nail at effective concentrations for several weeks after discontinuation of treatment . OBJECTIVE Our purpose was to verify whether intermittent terbinafine therapy is effective in dermatophytic onychomycosis and to compare the results of intermittent terbinafine with those of intermittent itraconazole and continuous terbinafine treatment . METHODS An open , r and omized study of 63 patients was performed with three treatment regimens : terbinafine , 250 mg daily ( 21 patients ) ; terbinafine , 500 mg daily for 1 week every month ( 21 patients ) ; or itraconazole , 400 mg daily for 1 week every month ( 21 patients ) . Treatment was continued for 4 months in toenail infections ( 60 patients ) and 2 months in fingernail infections ( 3 patients ) . RESULTS At the end of the follow-up period ( 6 months after discontinuation of treatment ) 16 of the 17 patients ( 94.1 % ) with toenail onychomycosis were mycologically cured in the terbinafine 250 mg group , 16 of 20 ( 80 % ) in the terbinafine 500 mg group , and 15 of 20 ( 75 % ) in the itraconazole group . CONCLUSION The percentage of patients who were mycologically cured was higher in the continuous terbinafine group than in the intermittent terbinafine and itraconazole groups , but statistical analysis did not reveal any significant difference between these cure rates Three multicenter , r and omized , double-blind , placebo-controlled studies were conducted to determine whether twelve weeks of therapy with itraconazole , 200 mg , was effective in the treatment of dermatophyte infection of the toenail . Significantly more patients treated with itraconazole ( 110 patients ) than with placebo ( 104 patients ) achieved clinical ( 65 percent vs. 3 percent ) and mycologic ( 54 percent vs. 6 percent ) success . The mean percentage of affected reference nail before the initiation of therapy was 76 percent . Adverse events were comparable in the two treatment groups . These findings demonstrate that twelve weeks of continuous itraconazole , 200 mg once daily , is a highly effective , well-tolerated therapy for the management of toenail onychomycosis In a r and omized , double‐blind , double‐placebo , multicentre study , terbinafine 250 mg daily for 12 weeks was compared with fluconazole 150 mg once weekly for 12 or 24 weeks in the treatment of onychomycosis . A total of 137 patients with culture‐confirmed onychomycosis was divided into three groups : group A received terbinafine for 12 weeks , group B received fluconazole for 12 weeks , while group C received fluconazole for 24 weeks . At completion of the study ( week 60 ) , the mycological cure rate was higher in the terbinafine group than in the fluconazole groups : 89 % vs. 51 % and 49 % , respectively ( P < 0·001 ) . The length of unaffected nail increased until week 24 in group B and until week 36 in group C , but was still increasing in group A at the final visit ( week 60 ) . Complete clinical cure of the target nail at week 60 was 67 % in the terbinafine group , compared with 21 % and 32 % in the fluconazole groups , respectively . The incidence of adverse events was low for both study agents . We conclude that terbinafine 250 mg daily for 12 weeks is significantly more effective in the treatment of onychomycosis than fluconazole 150 mg once weekly for either 12 or 24 weeks Terbinafine is an allylamine antifungal compound shown to be effective in the oral treatment of onychomycosis . Because of the fungicidal acivity of the drug , a shorter duration of treatment , compared with the currently used oral treatment modalities , can be expected in onychomycosis of the toenail . In the present r and omized study , the efficacy of oral terbinaifne treatment ( 250mg/day ) was assessed for periods of 6.12 , and 24 weeks . All patients were followed for up to 48 weeks after starting treatment . Of the 120 patients with toenail onychomycosis who entered the study , 98 were evaluable for efficacy . The involvement of the toenails was assessed both clinical ly and mycologically throughout the study . Evaluation at 24 weeks showed that complete cure of toenail onychomycosis was achieved in 67 % of patients treated for 6 weeks , 82 % treated for 12 weeks , and 85 % treated for 24 weeks . At the end of a further 24 weeks of follow‐up , cure rates were 40 % , 71 % and 79 % , respectively . The adverse effects of terbinafine were mostly mild‐to‐moderate gastrointestinal symptoms . Three patients discontinued treatment because of side‐effects . In conclusion , oral treatment with terbinafine is effective and generally well tolerated in patients with onychomycosis . Our results demonstrate that , for toenail onychomycosis , a treatment period of 12 weeks is sufficient Fifteen patients with onychomycosis caused by Trichophyton rubrum or T. mentagrophytes were treated with 50 mg itraconazole daily for 3 to 6 months . Fingernail infections were cured in two patients and two responded with marked improvement , e.g. small residual lesion remained and positive microscopy . The infected toenails were markedly improved in nine of 13 patients . Twenty-seven patients with T. rubrum infected nails were given 100 mg itraconazole daily for 6 to 8 months . Fingernails were cured in nine of eleven patients , while toenail infections were cured in one and markedly improved in 14 of 25 cases . Responses to 100 mg itraconazole versus 500 mg griseofulvin daily for 6 months were compared and evaluated in 20 patients with onychomycosis caused by T. rubrum or T. mentagrophytes . Fingernail infections responded equally well to both drugs with half of the cases cured or markedly improved , whereas toenails responded better to itraconazole , e.g. 4 of 9 were markedly improved versus one of 10 on griseofulvin . In patients given 50 mg itraconazole daily a significantly better response was observed in persons below 30 years of age compared to older individuals . Also , side-effects which were mainly mild and located to the gastro-intestinal tract or the central nervous system were seen less often in this group of patients on the low dose . Follow-up studies showed that cured nails remained cured , that markedly improved toenails continued to improve until cure in three of 21 patients but that aggravation took place through the one year of follow-up in more than half of the patients evaluated as markedly improved at the end of treatment In an open study 58 patients with chronic dermatophytosis mainly caused by Trichophyton rubrum and five patients with Tinea capitis were treated with ketoconazole . The indications were ineffectiveness of or side effects to griseofulvin . Response to treatment varied from 1 week in scalp infections to 11 weeks in toe-nail lesions . Dermatophytosis of h and s and feet were cured in 25 % , marked improvement observed in further 30 % . Toe- and finger-nail infections were cured in 20 % and 43 % , respectively , and marked improvement seen in further 36 % and 14 % , respectively . All scalp infections were cured without relapse . Recurrence of infections before 6 months after treatment was seen in 55 - 60 % of h and and foot lesions and 33 - 38 % of finger and toe-nail infections . In a double-blind study 20 patients with onychomycosis caused by T. rubrum the efficacy of ketoconazole was compared to that of griseofulvin . Cure rates in the griseofulvin group were 25 % for finger-nails and zero for toe-nails , while 50 % and 57 % experienced marked improvement . In the ketoconazole group , 25 % of finger-nail infections were cured and 75 % markedly improved , while the corresponding figures for toe-nails were 11 % and 89 % , respectively . Adverse reactions to ketoconazole were seen in 29 ( 46 % ) of the patients in the open study and in 2 ( 20 % ) in the double-blind study and comprised mainly minor complaints . Side effects caused discontinuation in 12 patients , in two of whom due to toxic hepatitis One – hundred and ninety – five patients with toenail tinea unguium were recruited to a multicentre double – blind clinical trial . Patients were given 250 mg terbinafine or 200 mg itraconazole daily for 12 weeks , with follow – up for a further 40 weeks . At the end of the study , mycological cure rates were 81 % ( 70/86 assessed ) for terbinafine and 63 % ( 53/84 assessed ) for itraconazole ( two – tailed , P < 0·05 ) . The length of unaffected nail was 9·44 mm in the terbinafine group and 7·85 mm in the itraconazole group ( two – tailed , P < 0·05 ) . Patient self– assessment also favoured terbinafine , with 65 % evaluating it as good to very good , compared with 58 % for itraconazole . Before treatment the terbinafine group had a mean of 6·7 and the itraconazole group 6·3 affected nails per patient . Total cure was achieved in 69 % of terbinafine and 61 % of itraconazole affected nails . We conclude that terbinafine is more effective than itraconazole In the treatment of toenail tinea infection The treatment of onychomycosis has previously often been protracted and unsuccessful . Terbinafine has been shown to be effective in short-term regimens . In this double-blind , placebo-controlled study , 148 patients with toenail dermatophytosis were r and omized to treatment with either 250 mg terbinafine daily or placebo for 3 months . An additional treatment was given for 3 months to patients whose infection had not responded . The patients were followed clinical ly and mycologically through 12 months . After 3 months 82 % of the terbinafine-treated group , versus 5 % of the placebo group , showed significant improvement , i.e. negative culture and growth of unaffected nail more than 2 mm ( p = < 0.0001 ) . After 12 months clinical and mycological cure was seen in 40 % of the patients treated with terbinafine for 3 or 6 months , while 67 - 81 % were clinical ly cured , but with positive microscopy . Side-effects occurred in 13.5 % of the terbinafine group , versus 5.4 % of the placebo group , and were mild . 250 mg terbinafine daily for 3 months was significantly more effective than placebo . The efficacy did not appear to improve with additional treatment for 3 months BACKGROUND Onychomycoses are among the most frequent nail diseases . The principal agents are dermatophytes . Itraconazole and terbinafine are two effective and systemic antimycotics . Previous trials have shown , that treatment schedules with effective concentrations for 3 months cause drug deposits in nail plates that persist 6 months after the end of the treatment . METHODS A comparative , open , prospect i ve study was carried out with r and om assignment of patients . The first group included 27 patients under treatment with 200 mg of itraconazole once daily for 3 months . The second group included 26 patients treated with 250 mg of terbinafine for 3 months . Both series of patients were followed for 6 additional months . RESULTS Both groups were similar in age , sex , and history of onychomycosis . Trichophyton rubrum was the main isolated agent in all patients . The percentage of diseased nails was similar in both groups affecting predominantly the first toenail . Treatment was highly effective and differences between groups were not significant . The rate of adverse events was 21 % in the itraconazole group and 47 % in the terbinafine group . CONCLUSIONS Itraconazole and terbinafine are two drugs of choice in dermatophytic onychomycosis BACKGROUND AND DESIGN In the treatment of onychomycosis , oral therapies have generally been given as a continuous-dosing regimen . For example , the suggested dose of itraconazole for the treatment of onychomycosis has thus far been 200 mg/d for 3 months . Based on the advances in our underst and ing of the pharmacokinetics of itraconazole , we investigated the efficacy and nail kinetics of intermittent pulse-dosing therapy with oral itraconazole in patients who were suffering from onychomycosis . Fifty patients with confirmed onychomycosis of the toenails , predominantly Trichophyton rubrum , were recruited and r and omly assigned to three ( n = 25 ) or four ( n = 25 ) pulses of 1-week itraconazole therapy ( 200 mg twice daily for each month ) . Clinical and mycological evaluation of the infected toenails , and determination of the drug levels in the distal nail ends of the fingernails and toenails , were performed at the end of each month up to month 6 and then every 2 months up to 1 year . RESULTS In the three-pulse treatment group , the mean concentration of itraconazole in the distal ends of the toenails ranged from 67 ( month 1 ) to 471 ( month 6 ) ng/g , and in the distal ends of the fingernails , it ranged from 103 ( month 1 ) to 424 ( month 6 ) ng/g . At month 11 , the drug was still present in the distal ends of the toenails at an average concentration of 186 ng/g . The highest individual concentrations of 1064 and 1166 ng/g were reached at month 6 for toenails and fingernails , respectively . At end-point follow-up , toenails in 84 % of the patients were clinical ly cured with a negative potassium hydroxide preparation and culture in 72 % and 80 % of the patients , respectively . In the four-pulse treatment group , the mean concentration of itraconazole in the distal ends of the toenails ranged from 32 ( month 1 ) to 623 ( month 8) ng/g , and in the distal ends of the fingernails , it ranged from 42 ( month 1 ) to 380 ( month 6 ) ng/g . The highest individual concentrations of 1549 and 946 ng/g were reached at month 7 for toenails and at month 9 for fingernails , respectively . At month 12 , the drug was still present in the distal ends of the toenails at an average concentration of 196 ng/g . At end-point follow-up , toenails in 76 % of the patients were clinical ly cured with a negative potassium hydroxide preparation and culture in 72 % and 80 % of the patients , respectively . There were no significant intergroup differences between the three- and four-pulse treatment groups for the primary efficacy parameters . The drug was well tolerated with no significant side effects in either patient group . CONCLUSIONS Following pulse therapy with itraconazole ( 400 mg/d given for 1 week each month for 3 to 4 months ) , the drug has been detected in the distal ends of nails after the first pulse , and it has reached therapeutic concentrations with further therapy . After stopping the last pulse , the drug remains in the nail plate at levels above 300 ng/g for several months . Clinical cure rates between 76 % and 84 % and negative mycological examination findings between 72 % and 80 % , respectively , were observed in toenail onychomycosis . The data suggest that pulse therapy with itraconazole is an effective and safe treatment option for onychomycosis Terbinafine , an orally active antifungal agent , is effective in the treatment of dermatophyte onychomycosis when given for 12 months in the case of toenail infection ( TN ) and 6 months for fingernail infection ( FN ) . The rapid response and short mycological cure time indicate a potential for a reduced treatment duration . In this multicentre double‐blind placebo‐controlled trial , 112 patients with mycologically proven dermatophyte onychomycosis were given 250 mg/day of terbinafine for 3 months . Twenty‐seven patients were excluded , leaving 85 fully evaluable [ average age 44 ( range 19–78 ) years ; 55 men ; 75 TN , 10 FN ] . Forty‐nine of the TN patients and seven of the FN patients received terbinafine . At the end of the follow‐up period , the TN mycological cure rate with active treatment was 82 % ( 37/45 ) , but no patient taking placebo maintained mycological cure ( P<0.001 ) . Of the FN patients treated with active drug , 71 % ( 5/7 ) achieved mycological cure at the end of follow‐up . Minor side‐effects occurred in 41 % of the placebo‐treated group compared with 33 % of those taking terbinafine . These adverse events were mainly gastrointestinal . Two patients taking terbinafine discontinued treatment — one with tonsillitis and another with diarrhoea . In conclusion , 3‐month treatment with terbinafine is effective , well tolerated and safe in dermatophyte onychomycosis . Short duration therapy for this indication represents a major therapeutic advance An open , comparative , r and omized study was conducted using griseofulvin or itraconazole for the treatment of onychomycosis of the foot . Group I ( 45 patients ) received itraconazole and Group II ( 45 patients ) received griseofulvin . Each group was divided into three subgroups that received different topical treatment : antimycotic cream ( isoconazole 1 % ) , keratolytic cream ( urea 40 % ) , or placebo cream . The itraconazole group showed complete clearance in combination with isoconazole cream in 73.3 % ( 11 of 15 patients ) , in combination with keratolytic cream in 78.5 % ( 11 of 14 patients ) , and in combination with placebo cream in 91.6 % ( 11 of 12 patients ) . The griseofulvin group showed complete clearance in combination with isoconazol cream in 46.1 % ( 7 of 15 patients ) , in combination with keratolytic cream in 42.8 % ( 6 of 15 patients ) , and in combination with placebo cream in 26.6 % ( 4 of 15 patients ) . The itraconazole group showed better results compared with the griseofulvin group when the chi-square statistical method was used The purpose of this study was to compare the efficacy of different dosage regimens in the management of onychomycosis with itraconazole and to determine the results of a further 1-week intermittent pulse treatment in non-cured patients . In this study , 153 patients were r and omly allocated to four groups . Patients in group A were treated with daily doses of 100 mg for 3 months in the case of fingernail onychomycosis and for 4 months in the case of toenail onychomycosis . Patients in the other groups received a intermittent pulse therapy , in which the drug was taken for 1 week , then discontinued for 3 weeks , three cycles for fingernail and four cycles for toenail infection . The daily doses were 400 mg ( group B ) , 300 mg ( group C ) and 200 mg ( group D ) . After therapy , non-cured patients were treated further with one cycle in which the daily dose was 400 mg . Patients were subsequently observed for 9 months and efficacy was assessed by mycological examination and the growth of unaffected nails . At the end of the therapy , the cure rates in the four groups were 19.1 % ( A ) , 15.2 % ( B ) , 18.9 % ( C ) and 17.9 % ( D ) , and no significant differences were found between each of B , C , D and A. At the end of the study , the cure rates were 76.2 % , 91.3 % , 78.4 % , 28.6 % respectively . The group that received further treatment had a cure rate of 55.6 % at the end of the first month and of 83.3 % in the second month . Drug tolerability was equally good in the four groups . Intermittent pulse therapy with a daily dose of 400 mg had the highest cure rate . Treatment of improved but non-cured patients with a dose of 400 mg intermittent pulse therapy markedly increased the cure rate . All treatment regimens were well tolerated Background : In recent years , itraconazole pulse therapy for onychomycosis has been developed [ three 1-week pulses with itraconazole 400 ( 2 × 200 ) mg daily every month ] . This has proved an effective and safe regimen which requires only 50 % of the medication used for continuous dosing schedules . Parallel to the development of the new dosage schedule , additional studies were conducted to further document the safety and efficacy of itraconazole 200 mg once daily for 3 months to treat onychomycosis . Objective : To compare the safety of itraconazole 200 mg once daily for 3 months , with or without itraconazole 200 mg once weekly for a further 3 months , with that of miconazole cream twice daily for 6 months , in the treatment of onychomycosis . Treatment efficacy was compared as a secondary objective . Methods : In this multicenter , double-blind study , patients were r and omized to receive itraconazole 200 mg once daily for 3 months followed by either itraconazole 200 mg once weekly for 3 months ( ITR-ITR group , n = 599 ) or oral placebo once weekly for 3 months ( ITR-PLAC group , n = 613 ) , or to receive miconazole cream twice daily for 6 months ( MIC-MIC group , n = 396 ) . The primary variable was elevation of alanine aminotransferase ( ALT ) concentration above 50 U/l . Results : Overall incidence of elevation of ALT concentration above 50 U/l , adverse events and rate of withdrawal because of adverse events were low and similar in the three treatment groups . Efficacy was significantly greater in the ITR groups than the MIC-MIC group . Conclusion : Itraconazole and miconazole were well tolerated and had no significant effect on liver function , but itraconazole was significantly more effective To evaluate the incidence , severity , and course of ketoconazole‐ associated hepatic injury , 211 patients with onychomycosis were r and omized by a ratio of 2:1 to receive either ketoconazole ( 137 patients ) or griseofulvin ( 74 patients ) . All of them were seronegative for hepatitis B surface antigen ( HBsAg ) and anti‐hepatitis C virus ( HCV ) and had no biochemical abnormality before therapy . The two groups were comparable in age , sex , and pretherapy liver biochemical tests . Liver biochemical tests were followed up biweekly for 3 months , and then at monthly intervals during the remaining course of therapy . No biochemical abnormality or hepatic injury was found in patients during griseofulvin treatment . Of the patients treated with ketoconazole , 24 ( 17.5 % ; 95 % confidence interval [ CI ] , 11.1 % to 23.9 % ) showed asymptomatic transaminase elevation . Ketoconazole was discontinued immediately after overt hepatitis developed in another 4 patients ( 2.9 % ; 95 % CI , 0.1 % to 5.7 % ) who did not succumb to hepatic decompensation . The abnormal biochemical changes in patients with overt hepatitis returned to normal after discontinuing ketoconazole . Elderly patients were more prone to develop overt hepatitis . In patients with asymptomatic liver injury , the abnormal biochemical changes gradually returned to normal despite continuing ketoconazole therapy . The results of this cohort study suggest that ketoconazole‐induced overt hepatitis is more common than previously believed and that transient sub clinical injury is much more common than overt hepatitis . Therapy with ketoconazole may be continued with caution in the absence of symptoms and /or hyperbilirubinemia , but should be discontinued if overt hepatitis occurs Previous studies evaluating short-term itraconazole and terbinafine therapy for onychomycosis have varied in protocol and size ; this double-blind study enabled a large-scale , st and ardized , direct comparison . Patients with toenail onychomycosis were r and omized to itraconazole 200 mg daily ( n = 146 ) or terbinafine 250 mg daily ( n = 146 ) for 12 weeks , with a 36-week follow-up . Mycological cure rates at the follow-up end-point were significantly equivalent ( 61 % with itraconazole vs. 67 % with terbinafine ) . A similar proportion of patients in each group experienced adverse events during treatment ( itraconazole , 22 % ; terbinafine , 23 % ) . More patients receiving terbinafine stopped treatment permanently because of treatment-related adverse events ( 8 % vs. 1 % ) Assessing the quality of r and omized controlled trials ( RCTs ) is important and relatively new . Quality gives us an estimate of the likelihood that the results are a valid estimate of the truth . We present an annotated bibliography of scales and checklists developed to assess quality . Twenty-five scales and nine checklists have been developed to assess quality . The checklists are most useful in providing investigators with guidelines as to what information should be included in reporting RCTs . The scales give readers a quantitative index of the likelihood that the reported methodology and results are free of bias . There are several shortcomings with these scales . Future scale development is likely to be most beneficial if questions common to all trials are assessed , if the scale is easy to use , and if it is developed with sufficient rigor BACKGROUND Fluconazole is a bis-triazole antifungal agent approved for the treatment of oropharyngeal , esophageal , and vaginal c and idiasis , serious systemic c and idal infections , and cryptococcal meningitis . OBJECTIVE The purpose of this study was to evaluate three different duration s of once-weekly fluconazole for the treatment of onychomycosis of the toenail caused by dermatophytes . METHODS In a multicenter , r and omized , double-blind , parallel , placebo-controlled trial , 384 patients with distal subungual onychomycosis of the toenail received fluconazole , 450 mg once weekly , or placebo for 4 , 6 , or 9 months . For inclusion , patients were required to have mycologically confirmed distal subungual onychomycosis of the toenail with a large toenail at least 25 % clinical ly affected but having at least 2 mm of healthy nail between the nail fold and the proximal onychomycotic border . Efficacy was assessed by clinical and mycologic ( microscopic and microbiologic ) measures at screening , at every treatment visit starting at month 3 , and at months 2 , 4 , and 6 after therapy . Observed or volunteered adverse events were recorded and classified at all visits . RESULTS At the end of treatment , very significantly superior clinical and mycologic results were achieved in all fluconazole groups compared with placebo ( p=0.0001 ) . This superiority was largely maintained over 6 months of follow-up . The clinical and mycologic responses of the 9-month treatment duration were significantly superior to the 4- and 6-month duration s. Similar percentages of patients in the fluconazole and placebo groups reported adverse experiences for all three duration s of the study . CONCLUSION Results of this study support the efficacy and safety of fluconazole in the treatment of distal subungual onychomycosis of the toenail We report on the use of a new orally active fungicidal agent , terbinafine ( SF 86–327 , Lamisil ) in the treatment of patients with dermatophyte onychomycosis . Twenty patients with toe‐nail , and 10 with finger‐nail infection received 250 mg of terbinafine daily : finger‐nail infections were treated for 6 months and toe‐nail infections for 12 months . All 24 patients who completed the course of therapy achieved mycological cure , as did two subjects who dropped out of the trial . All but two patients had clinical ly normal nails at the end of the study period . The mean time for mycological cure was 12.5 weeks for finger‐nail infection , and 24 weeks for toe‐nail infections . The time for a clinical cure with normal nails was 20.5 weeks for finger‐nail infection , and 44 weeks for toe‐nail infection . An exacerbation of pre‐existing dyspepsia occurred in three of the six patients who did not complete the trial but there were no other significant adverse reactions A multicentre trial for the treatment of dermatophyte onychomycosis of the toenails with terbinafine was carried out in Australia and New Zeal and . Between eight and 12 nail sample s were obtained from each of the 118 patients in the 48‐week trial , and each sample was investigated by direct microscopy and culture for dermatophyte and non‐dermatophyte fungi . Patients were r and omized to treatment with terbinafine at 250 mg/day or placebo for the first 12 weeks of the study , then non‐ responders were offered a 12‐week course of terbinafine from week 28 . All patients had a dermatophyte infection . In 42 patients ( 36 % ) microscopy and mycological culture identified dermatophytes alone . In the remaining 76 patients ( 64 % ) , a non‐dermatophyte mould or yeast was also isolated at some stage during the trial , but in only three patients did the same non‐ dermatophyte persist in two or more successive nail specimens . The presence of a fungal con‐ taminant in addition to a dermatophyte had no apparent effect on the efficacy of treatment with terbinafine . We conclude that non‐dermatophyte moulds and yeasts are generally found as contaminating organisms in dermatophyte onychomycosis , secondary to the dermatophytes , and that they do not infiuence the outcome of treatment 30 patients with totally 178 toenails infected with Trichophyton rubrum were r and omly treated with ketoconazole alone for 4 months ( group A ) or in combination with chemical nail avulsion ( group B ) . Of the 14 patients in group A who completed the treatment , 4 ( 28 % ) were cured 6 months later , compared to 8 ( 53 % ) of 15 patients in group B. In 4 cases , transient elevated hepatofunction enzymes occurred . Gastrointestinal disturbances caused withdrawal in 1 case Terbinafine , an orally active antifungal agent of the allylamine class , is effective in the treatment of dermatophyte onycomycosis . Its pharmacologic and pharmacokinetic properties give strong support to the possibility that intermittent treatment courses may be equally effective in onychomycosis in general . The present r and omized and controlled study was carried out to determine whether intermittent therapy with terbinafine was effective in dermatophyte toe-onychomycosis . Sixty patients with mycologically proven toenail dermatophyte onychomycosis were included in the study . Patients were equally allocated to treatment groups in a r and om manner . Group 1 was given 250 mg/day of terbinafine for 3 months . Group 2 was given 500 mg/day of terbinafine for 7 days during the first week of each month for 3 months . Nails were examined clinical ly and mycologically at monthly intervals . All patients were followed up for 48 weeks after starting the treatment . Of the patients who entered the study , 24 in Group I and 23 in Group 2 were evaluable for efficacy . At the end of the follow-up period , the cure rate ( negative microscopy and culture ) was 79.2 % in Group 1 and 73.9 % in Group 2 ; this difference was not significant ( p : 0.79 ) . The results indicate that intermittent therapy with terbinafine is as effective as 3-month treatment in dermatophyte toe-onychomycosis In this multicentre , double – blind , parallel group study , we evaluated the efficacy and safety of continuous treatment with itraconazole , 200 mg daily for 3 months , in comparison with itraconazole pulse therapy , 400 mg daily 1 week per month for 3 months , in the treatment of toe – nail onychomycosis . The study included 129 patients with distal subungual onychomycosis of the toe – nails , confirmed by microscopy and positive for dermatophyte culture ; 65 received continuous treatment and 64 received pulse therapy . Patients were followed up for 9 months after treatment Patients with toe‐nail onychomycosis were treated with terbinafine ( 250 mg daily , n= 20 ) for either 6 or 12 weeks in a r and omized double‐blind study . Plasma and distal nail clippings were taken before initiation of therapy and 1 , 6 , 12 , 18 , 24 , 36 and 48 weeks thereafter Eight US centers enrolled in a multicenter , r and omized , double-blind , placebo-controlled , parallel-group trial comparing the efficacy of 12 , 16 , and 24 weeks of oral therapy with terbinafine , 250 mg/day , and placebo in patients aged 18 to 75 years with both a positive KOH wet mount and mycologic culture of one or more dermatophytes from the large toenail , design ated as the target toenail , or another infected toenail if no large toenail was infected . Primary exclusion criteria included : systemic antifungal therapy during the previous 3 months ; topical antifungal therapy for the infected toenail(s ) during the previous month ; white superficial toenail onychomycosis ; immunosuppression or immunodeficiency , including known human immunodeficiency virus ( HIV ) infection ; hepatic enzymes > 1.5 times the upper limit of normal at screening ; and any marked laboratory abnormalities . Patients were r and omized into four treatment groups : ( i ) 12 weeks of terbinafine ( 250 mg/day ) followed by 12 weeks of placebo ; ( ii ) 16 weeks of terbinafine followed by 8 weeks of placebo ; ( iii ) 24 weeks of terbinafine ; and ( iv ) 24 weeks of placebo . Both patient and physician were blinded to the treatment for the 24-week treatment period . Blinding was maintained through the end of the study . Assessment s were done at week −6 ( screening visit ) and at weeks 4 , 8 , 12 , 16 , 20 , and 24 during the treatment period . Follow-up assessment s were scheduled for weeks 30 , 36 , 42 , 48 , 60 , and 72 . The mycologic efficacy variables included the percentage of patients with negative mycologic cultures , with negative KOH wet mounts , and with mycologic cure ( both negative culture and negative KOH ) . The evaluations at week 48 and week 72 are reported here . The primary clinical variable was clinical cure , defined as 0 % involvement of the target toenail . The efficacy analysis included all patient who were r and omized to therapy , fulfilled the mycologic criteria at screening , took at least one dose of study drug , and had at least one post-baseline assessment . For each variable , the percentage in each treatment group showing efficacy was compared with the percentage in the corresponding placebo group In this open , r and omized , parallel-group , the efficacy and safety of itraconazole pulse therapy ( 1 week 400 mg daily , 3 months ) was evaluated in comparison with continuous terbinafine dosing ( 250 mg daily , 3 months ) for the treatment of toenail onychomycosis . The study included a total of 51 patients with distal subungual onychomycosis of the toenails confirmed by microscopy and positive culture . Twenty-six patients received itraconazole pulse therapy and 25 patients received continuous terbinafine therapy . A minimum of 50 % nail involvement was a requirement for inclusion . In total , 153 nails ( 121 toenails ) were treated with itraconazole pulse therapy and 162 nails ( 122 toenails ) were treated with continuous terbinafine therapy . Patients were evaluated every third month for 9 months after treatment . Photographs were taken at each visit . Clinical success and mycologic cure ( negative potassium hydroxide preparation and culture ) were the main outcome measures . Mycologic cure rates were 75 % in the itraconazole pulse group and 76 % in the continuous terbinafine group at month 12 ; the corresponding clinical response rates were 77 % and 68 % , respectively . Six ( 23 % ) patients in the itraconazole group reported 7 adverse events and 13 ( 52 % ) patients in the terbinafine group reported 19 adverse events . In the terbinafine group , 12 % discontinued therapy due to adverse events ; no patients in the itraconazole arm discontinued . Both therapies showed comparable efficacy , though baseline nail severity was greater in the itraconazole group , and adverse effects were greater in the terbinafine group A parallel-group double-blind study was carried out which compared the efficacy of chemical avulsion of affected nail by urea 40 % and bifonazole 1 % cream alone with that of the same local therapy combined with short-term oral griseofulvin in onychomycosis . A total of 120 patients were included in the study . Patients ' characteristics were comparable in both treatment groups . Of the 98 patients fully evaluated , 91 had toenail involvement and only seven had fingernail involvement . Forty-six of the patients were men and 51 were women . The mean age of the patients was 47.14 + /- 13.84 years ( range 17 - 80 years ) . The duration of onychomycosis was for more than 1 year in 96 patients and for 3 months duration in only one patient , who was in the placebo group . Forty patients had received different previous therapies . All topical treatments were discontinued for at least 2 weeks and oral therapy for at least 2 months prior to the beginning of the study . The diagnosis was confirmed by positive mycologic cultures . Trychophyton rubrum was identified as the pathogen in 90 patients , 45 in each group , T. tonsurans in four patients , two in each group , and T. mentagrophytes in three patients , two in the griseofulvin treated group , and one in the placebo group . The first phase of treatment given to all patients consisted of occlusive dressing every 24 h with urea 40 % and bifonazole 1 % ointment until the infected nail became completely detached . Subsequently , in the second phase bifonazole 1 % cream was applied to the nail ped every 24 h for 4 weeks . In addition , concomitantly with the bifonazole cream the patients were r and omly allocated to a daily oral double-blind treatment with griseofulvin 500 mg or placebo , for 4 weeks . Clinical and mycologic evaluations were carried out at baseline , immediately after removal of the nail , and at 3 days , 4 weeks , and 4 months after the end of treatment with bifonazole cream and griseofulvin/placebo tablets . Mycologic examination included identification of fungi by KOH preparation and culture on potato dextrose agar . Positive cultures were transfered for identification on Sabouraud 's . Criteria for evaluation of efficacy comprised : " cure " defined as clinical and mycologic cure ( fresh specimen and culture negative ) at both investigation times after the end of treatment ; " late cure " defined as mycologic cure at both investigation times after the end of treatment , clinical clearing of the nail only 4 months after the end of treatment ; " improvement " defined as mycologic cure and only partial clinical improvement at both times after the end of treatment ; " failure " indicating no mycologic cure ( fresh specimen and /or culture positive ) ; and " relapse " signifying a change from negative findings 1 month after the end of treatment to positive findings 4 months after the end of treatment . Adverse reactions were evaluated on each visit . Only those patients who had completed clinical and mycologic evaluation during the entire study were included in the final statistical analysis . Those patients with partial evaluation were included only in the evaluation of adverse events . Based on the assumptions of a failure rate ( failure and relapse ) of 30 % with bifonazole cream alone and of 10 % with bifonazole cream and griseofulvin tables , a = 0.05 and b = 0.2 the required sample size was at least 58 patients for each treatment group ( Casagr and e formula , one-sided test ) . The primary efficacy variable " assessment of treatment " ( cure and improvement versus failure and relapse ) was tested for treatment differences by Fisher 's exact test ( a = 0.05 , one-sided test ; Ho , no advantage with additional systemic therapy of griseofulvin ) . Additionally , the relapse rates of both treatments were tested exploratively in the same way as the primary efficacy variable . All other data were analyzed descriptively BACKGROUND AND DESIGN The fungicidal mode of action of terbinafine should make it feasible to reduce treatment duration in onychomycosis . For this reason , a r and omized , double-blind study in 195 patients with severe dermatophyte infections of the toenails was performed comparing a 24-week treatment with terbinafine ( 250 mg/d ) with a 48-week treatment with micronized griseofulvin ( 1000 mg/d ) . RESULTS After 48 weeks , effective treatment was achieved in 67 % of the patients treated with terbinafine and in 56 % of those treated with griseofulvin ( two-tailed P = .120 ) . At a follow-up visit 24 weeks later , cure rates had decreased to 60 % in the terbinafine group and to 39 % in the griseofulvin group ( two-tailed P = .006 ) . At the same time , the mycological cure rate was 81 % with terbinafine and 62 % with griseofulvin ( two-tailed P = .02 ) . CONCLUSIONS This study has demonstrated the longterm therapeutic superiority of terbinafine to high-dose griseofulvin in the treatment of toenail mycosis . Furthermore , with the new antifungal terbinafine , treatment is no longer necessary until all affected nail material has grown out BACKGROUND Because of the relative clinical inefficacy of antifungal therapy in the past , onychomycosis has largely been viewed as an incurable condition . The availability of two new oral antifungal agents suggests the possibility of revising this clinical precept . OBJECTIVE This study compared the efficacy and tolerability of terbinafine and itraconazole in the treatment of onychomycosis of the toenails . METHODS This investigation was a multicenter , double-blind , parallel group study . The primary therapeutic endpoints measured were mycologic cure and clinical improvement . RESULTS Mycologic cure rates ( negative culture and microscopy ) at the end of the study were 81 % for terbinafine versus 63 % for itraconazole ( 2p < 0.01 ) . A total of 92 % of terbinafine-treated patients had negative cultures at the end of the study , compared with 67 % of itraconazole-treated patients ( 2p < 0.0001 ) . Terbinafine was more effective than itraconazole in increasing the length of the unaffected area of the target nail : 9.44 mm versus 7.85 mm ( 2p < 0.05 ) . CONCLUSION Terbinafine is more effective than itraconazole in the treatment of toenail onychomycosis BACKGROUND Onychomycosis is an increasing problem with limited therapeutic options . OBJECTIVE We evaluated the safety and efficacy , of oral terbinafine , a new fungicidal antimycotic , in patients with toenail onychomycosis . METHODS A North American multicenter , double-blind , placebo-controlled study evaluated the mycologic and clinical efficacy of oral terbinafine 250 mg/day for 12 or 24 weeks in 358 patients with toenail onychomycosis . RESULTS A total of 74 % of patients treated with 12 or 24 weeks of terbinafine achieved a successful clinical outcome . Approximately 11 % of terbinafine responders showed evidence of relapse 18 of 21 months after cessation of treatment . Terbinafine was well tolerated ; most adverse events were transient and mild to moderate in severity . CONCLUSION The results of this study confirm that oral terbinafine is a safe and effective therapy for the treatment of onychomycosis |
1,332 | 10,735,797 | We conclude that there was evidence for a statistically significant but clinical ly question able , important effect of intraperitoneal LA for postoperative pain control .
There was evidence for a significant but short-lasting effect of mesosalpinx/fallopian tube block after sterilization , but there was a lack of evidence for any important effect of port-site infiltration .
This systematic review confirms intraperitoneal and mesosalpinx local anesthetic block , not port-site infiltration , to have some impact on postoperative pain after laparoscopy | UNLABELLED In a systematic review , we evaluated r and omized controlled trials ( RCTs ) of peripheral local anesthetics ( LA ) compared with placebo or no treatment in the control of postoperative pain after laparoscopic surgery .
IMPLICATION S A systematic review summarizes , through transparent methodology , available information from r and omized , controlled trials to produce the best available evidence -based estimate of a " true " clinical effect of an intervention . | Objective We tested the hypothesis that local anesthetic administered before skin incision , an example of preemptive analgesia , reduces postoperative pain for women undergoing laparoscopy , as compared with postincisional local anesthetic or placebo . Methods Patients undergoing diagnostic laparoscopy were r and omized to one of three blinded treatment groups . Treatment group A patients received local infiltration of 0.5 % bupivacaine at the surgical site before incision and a saline placebo infiltration before incision closure . Treatment group B received the saline placebo before skin incision and bupivacaine after laparoscopy but before closure of the skin incisions . For treatment group C patients , saline was infiltrated as a placebo before and after laparoscopy . All patients underwent a st and ardized general anesthetic induction and maintenance . Postoperative pain was evaluated using the modified McGill Present Pain Intensity scale . Pain and supplementary analgesic use was compared among the three treatment groups . Results A total of 57 patients completed the study for analysis . Age , weight , height , race , indication , and operating time did not vary significantly between the three groups . By 24 hours after surgery , patients in treatment group A reported significantly lower pain scores ( McGill Present Pain Intensity Scale : 0.5 ± 0.9 ) than either treatment group B ( 1.6 ± 1.3 ) or C ( 1.3 ± 1.2 ) . Group A patients also could tolerate a significantly longer time delay to their first analgesic medication than patients who received postincisional bupivacaine or than control patients who received no bupivacaine . Conclusion The preemptive administration of bupivacaine before laparoscopy results in decreased postoperative pain and should allow a more rapid return to normal activities . The popular practice of infiltrating bupivacaine at time of incision closure does not offer any benefit in the control of pain after laparoscopy Following 189 laparoscopic sterilizations with the Falope-ring , 33 cases of peroperative complications were registered . Laparotomy was required in one case . Sterilization undertaken in connection with termination of pregnancy was not associated with more peroperative complications than sterilization performed during an interval phase . In a r and omized trial comprising 100 women it was not possible to demonstrate that application of lidocaine to the tube reduced the incidence of immediate postoperative abdominal pain which occurred in 18 % of the women in the control group . A follow-up investigation of 91 women revealed change in bleeding pattern in 32 % and low abdominal pain de novo in 40 % . The frequencies of changes in bleeding pattern and of low abdominal pain were greater in women who had previously employed oral contraception than in women who had not done so . A question naire investigation comprising 169 women revealed that 38 % had developed one or more of the following symptoms : hot flushes , tendency to depression and irritability , and tachycardia . Alterations in libido were found in 26 % . 2 % regretted the sterilization . One pregnancy occurred in 172 sterilized women after an average observation period of 13 months Approximately 200 women of American Society of Anesthesiologists class I and II physical status electing outpatient laparoscopic tubal sterilization with Yoon rings were involved in a double-blind study to evaluate postoperative pain relief after intraoperative suprapubic infiltration of the fallopian mesosalpinx . The postoperative pain levels were lower after bilateral infiltration of 0.5 % bupivacaine beneath the site of ring application . Postoperative , suprapubic infiltration provided safe , prolonged and effective pain relief , allowed prompt ambulation and early discharge , and reduced the need for narcotic analgesics and postoperative analgesia Narcotic requirements in 51 day-surgery patients following laparoscopic tubal occlusion were significantly reduced ( P less than .01 ) by the use of 1 % etidocaine 5 mL , dropped on each fallopian tube from uterus to fimbrias before tubal b and ing when compared with a control group of 51 day-surgery patients who had no topical anesthetic agent . All patients received general anesthesia . Although there was no significant difference in nausea rate , the incidence of vomiting was decreased . Eight of 51 patients ( 16 % ) having topical etidocaine and 19 of 51 ( 37 % ) who had no etidocaine vomited during the postoperative period . The frequency of overnight stay was significantly reduced in the topical etidocaine group of patients ( P less than or equal to .01 ) Objective To investigate the efficacy of applying 10 ml bupivacaine 0.5%versus normal saline to the fallopian tubes under direct vision during day case laparoscopic sterilisation under general anaesthesia After laparoscopic cholecystectomy , CO2 remains within the peritoneal cavity , commonly causing pain . This prospect i ve r and omized study was performed to determine the efficacy of intraperitoneal normal saline and bupivacaine infusion on postoperative pain after laparoscopic cholecystectomy . Three hundred patients were r and omly assigned to one of six groups of 50 patients each . Group A patients served as controls . In group B patients , normal saline was infused under the right hemidiaphragm and suctioned after the pneumoperitoneum was deflated . After suction , a subhepatic closed drain was left for 24 h. In group C patients , bupivacaine 1.5 mg/kg in solution 2.5 mg/ml , minus 15 ml of this solution , which was infiltrated in the trocar wounds , was infused under the right hemidiaphragm at the end of the cholecystectomy . In group D patients , bupivacaine was given as in group C , but a subhepatic drain was left for 24 h. In group E patients , normal saline was used as in group B plus bupivacaine as in group C. Group F patients were treated as in group E , but a subhepatic drain was left for 24 h. In all groups , 15 ml of a 2.5 mg/ml bupivacaine solution was infiltrated in the trocar wounds . Postoperatively , analgesic medication usage , nausea , vomiting , and pain scores were recorded at 2 , 6 , 12 , 24 , 36 , 48 , and 72 h. Postoperative pain was reduced significantly in the patients of the treatment groups vs. the controls . Between treatment groups , patients in groups B , E , and F had the best results , while those in groups C and D had significantly greater pain than those in groups B , E , and F. It is concluded that postoperative pain after laparoscopic cholecystectomy can be significantly reduced by intraperitoneal normal saline infusion subdiaphragmatically and after its postdeflation suction , bupivacaine infusion in the same area , or without bupivacaine in case a subhepatic drainage has been needed This r and omized double-blind placebo-controlled study was design ed to evaluate the effects on postoperative pain of the local anesthetic , 0.5 % bupivacaine with epinephrine , sprayed hepatodiaphragmatically under the surgeon 's direct view during laparoscopic cholecystectomy . Metabolic endocrine responses to surgery ( glucose and cortisol ) and nonsteroidal anti-inflammatory drug requirements were investigated , as well as the presence of nausea , vomiting , and sweating . Local anesthetics or placebo solutions were given as follows . Immediately following the creation of a pneumoperitoneum , surgeons sprayed the first 20 mL of solution ( S1 ) , and an additional 20 mL of solution ( S2 ) was sprayed at the end of the operation . Patients were classified into three groups ( 14 patients per group ) . Group A received 20 mL of saline during both S1 and S2 , group B received 20 mL of saline during S1 and 20 mL of bupivacaine during S2 , and group C received 20 mL of bupivacaine during both S1 and S2 . The degree of postoperative pain was assessed using the visual analogue scale ( VAS ) and the verbal rating scale ( VRS ) on arrival in the recovery room and subsequently at time intervals of 4 h , 8 h , 12 h , and 24 h. The results of this study indicate a significant decrease of postoperative pain in patients treated with local anesthetic . VAS and VRS pain scores , as well as respiratory rate and analgesic requirements , were significantly lower in group C. The postoperative plasma cortisol level in group C was significantly lower than in groups A and We investigated , in a double-blind study , the effects of intraperitoneal local anesthetics during laparoscopic cholecystectomy . In Part A of the study 30 patients received 50 mL saline 0.9 % ( A 0 ) , bupivacaine 0.125 % ( A 125 ) , or bupivacaine 0.25 % ( A 25 ) intraperitoneally at the end of surgery . Mean maximum plasma concentrations of bupivacaine reached 0.48 mg/L ( range 0.15 - 0.90 mg/L ) in Group A 125 and 1.0 mg/L ( 0.35 - 2.10 mg/L ) in Group A 25 within 15 min ( range , 5 - 30 min ) . There was no significant difference in pain scores or opioid consumption ( patient-controlled analgesia with piritramid ) : 24 , 28 , and 13 mg/24 h among the study groups , respectively ( not significant ) . Postoperative respiratory function deteriorated in comparison to preoperative values in all study groups , but the forced vital capacity was significantly more impaired in Group A.25 . In Part B , 24 patients received placebo ( B 0 ) or bupivacaine 0.25 % ( B 25 ) . Postoperative hypoxemic periods ( oxygen saturation < 92 % ) were significantly more frequent in Group B 25 . Considering the question able benefits and the potential risks , we would not recommend the application of intraperitoneal bupivacaine during laparoscopic cholecystectomy . ( Anesth Analg 1995;81:967 - 72 OBJECTIVE To evaluate the efficacy of intraperitoneal subdiaphragmatic instillation of lidocaine and trocar site infiltration of bupivacaine to minimize postoperative pain after diagnostic microlaparoscopy performed under local anesthesia with conscious sedation . DESIGN Prospect i ve r and omized study . SETTING Day-surgery unit of Endogyn Service , Naples , and Department of Gynecologic and Pediatric Sciences , Reggio Calabria University , Catanzaro , Italy . PATIENT(S ) Sixty-one women with infertility . INTERVENTION(S ) All patients received local anesthesia and conscious sedation before surgery . After the microlaparoscopy , the treatment group was given 40 mL of intraperitoneal subdiaphragmatic 0.5 % lidocaine and 5 mL of 0.5 % bupivacaine that was infiltrated into the trocar insertion sites . The control group received no treatment . When necessary , ketoprofene or ketorolac were administered IM after surgery . MAIN OUTCOME MEASURE(S ) Postoperative pain was evaluated with the use of a visual analog scale with scores ranging from 1 - 10 immediately after surgery and over the next 48 hours . The rate at which patients were discharged from the hospital 2 hours after surgery also was recorded . RESULT ( S ) The treatment group had significantly lower pain scores both immediately after surgery and 1 , 3 , and 6 hours afterward . The need for postoperative analgesics also was significantly lower in the treatment group . The rate at which patients were discharged 2 hours after surgery was significantly higher in the treatment group . CONCLUSION ( S ) Postoperative intraperitoneal lidocaine administration and bupivacaine infiltration of the trocar sites is beneficial for patients undergoing microlaparoscopy . The effect of these drugs is temporary , but they can significantly decrease postoperative pain for approximately 6 hours and reduce the need for additional analgesics . Most important , the rate at which patients can be discharged from the hospital only 2 hours after surgery is increased significantly After laparoscopic cholecystectomy , residual gas is inevitably retained in the peritoneal cavity . An active attempt is not always made to remove it . Using a double-blind prospect i ve protocol in 40 healthy patients , we evaluated the effect of residual pneumoperitoneum on post-laparoscopic cholecystectomy pain intensity . On completion of surgery , prior to removal of the surgical instruments , the patients were r and omly divided into two groups : in the active aspiration ( AA ) group an active attempt was made to remove as much gas as possible from the peritoneal cavity , while in the nonactive aspiration ( NAA ) group no such effort was made . Postoperative pain was assessed hourly over a 4-h period with a visual analog scale ( VAS ) and a patient-controlled analgesia ( PCA ) device . During the first postoperative hour , the NAA patients made significantly ( P < 0.05 ) more dem and s ( mean ± SD ) for morphine than those in the AA group ( 31.3 ± 26.2 VS 15.3 ± 15.7 ) and also received a borderline significantly ( P = 0.056 ) larger dose ( mean ± SD ) of PCA morphine ( 3.9 ± 1.9 mg VS 2.7 ± 1.3 mg ) . The VAS scores ( mean ± SD ) over the 4-h study period were similar in both groups , being high during the first postoperative hour ( AA = 5.1 ± 2.1 VS NAA = 6.1 ± 2.2 ) and then decreasing . We conclude that residual pneumoperitoneum is a contributing factor in the etiology of postoperative pain after laparoscopic cholecystectomy Background A controversy exists over the effectiveness and clinical value of preemptive analgesia . Additional studies are needed to define the optimum intensity , duration , and timing of analgesia relative to incision and surgery . Methods One hundred twenty patients undergoing laparoscopic cholecystectomy under general anesthesia plus topical peritoneal local anesthetic or saline were studied . Local anesthetic ( 0.5 % bupivacaine with epinephrine ) or placebo solutions were given as follows : immediately after the creation of a pneumoperitoneum ( blocking before surgery ) , and at the end of the operation ( blocking after surgery ) . Patients were r and omly assigned to one of four groups of 30 patients each . Group A ( placebo ) received 20 ml 0.9 % saline both before and after surgery , group B received 20 ml 0.9 % saline before surgery and 20 ml local anesthetic after surgery , group C received 20 ml local anesthetic both before and after surgery , group P received 20 ml local anesthetic before and 20 ml 0.9 % saline after surgery . Pain was assessed using a visual analog scale and a verbal rating scale at 0 , 4 , 8 , 12 , and 24 h after surgery . Metabolic endocrine responses ( blood glucose and cortisol concentrations ) and analgesic requirements also were investigated . Results Pain intensity ( visual analog and verbal rating scales ) and analgesic requirements were significantly less in the group receiving bupivacaine after surgery compared to placebo . However , in the groups receiving bupivacaine before surgery , both pain intensity and analgesic consumption were less than in the group receiving bupivacaine only after surgery . Blood glucose and cortisol concentrations 3 h after surgery were significantly less in groups receiving bupivacaine before surgery . Conclusions The results indicate that intraperitoneal local anesthetic blockade administered before or after surgery preempts postoperative pain relative to an untreated placebo-control condition . However , the timing of administration is also important in that postoperative pain intensity and analgesic consumption are both lower among patients treated with local anesthetic before versus after surgery OBJECTIVE To evaluate the immediate postoperative pain and discomfort in patients who underwent operative laparoscopy under general anesthesia with or without peritoneal lidocaine and incisional bupivacaine instillations . DESIGN Fifty-four participants were prospect ively r and omized to three groups : group I , intraperitoneal ( IP ) lidocaine + intraincisional bupivacaine ; group II , intraincisional bupivacaine ; and group III , no additional drugs after general anesthesia ( controls ) . SETTING University Hospital , Reproductive Endocrinology and Infertility Clinics . PATIENTS Private patients needing operative laparoscopy . INTERVENTIONS One hundred milligrams of lidocaine were instilled with the irrigation device into the peritoneal cavity at the completion of surgery . Twenty-five milligrams of bupivacaine were injected into infraumbilical and suprapubic incisions . MAIN OUTCOME MEASURES The analgesic use and modified McGill Present Pain Intensity scores were used for pain evaluation . RESULTS McGill Present Pain Intensity scores for pain , and narcotic use in the recovery room were less in IP lidocaine-instilled group of patients ( P less than 0.05 ) . The mean maximum plasma lidocaine level achieved was 1.01 + /- 0.25 micrograms/mL. CONCLUSIONS Peritoneal lidocaine and incisional bupivacaine use in operative laparoscopy as described after general anesthesia is safe and effective in reducing postoperative pain in the recovery room Bupivacaine infiltration of the mesosalpinx was compared to lidocaine , normal saline or no injection for pain relief in women having elective laparoscopic tubal sterilization by Yoon fallopian ring application , One hundred women were assigned r and omly to four groups . In a double-blind study , the mesosalpinx was infiltrated in three groups : Group I - lidocaine one per cent ; Group II - bupivacaine 0.5 per cent ; Group III - normal saline . Group IV ( control ) received no injection . Pain intensity was reported at four study times by the patients on a self- assessment pain intensity scale . Responses were compared using the Kruskall-Wallis H-Test and Wilcoxen ’s Rank-Sum Test . Both tests indicated significant differences in pain intensity levels at various study times . The amount of supplemental fentany I given was used as a secondary measure of effectiveness . One-way analysis of variance ( ANOVA ) and Duncan ’s Multiple-Range Test showed the bupivcaine group to receive significantly less fentanyl ( p < 0.05 ) in the postanesthesia care unit . RésuméOn a comparé ľinfiltration de bupivacaine dans le mésosalpinx , è celle de la lidocaïne , du salin normal ou è aucune injection pour le soulagement de la douleur chez des femmes subissant une laparoscopie élective pour stérilisation tuhaire par anneaux de trompes de Yoon . On a réparti de façon aléatoire , 100 femmes en quatre groupes . Dans une étude è double insu , on a infiltré le mésosalpinx dans trois groupes : Groupe 1 - 1.0 pour cent de lidocaïne ; Group II-0.5 pour cent de bupivacaine ; Groupe III-salin normal . Le groupe IV ( groupe-témoin ) n’a pas reçu ď injection . Les patients ont rapporté ľintensité de leur douleur è quatre moments dans ľétude , en faisant une évaluation personnelle sur une échelle ďintensité de la douleur . On a comparé les réponses en utilisant le test H Kruskall-Wallis et le test de somme des rangs de Wilcoxen . Les deux tests démontraient des différences significatives dans les niveaux ďintensité de la douleur , è différents moments de ľétude . La quantité de fentanyl supplémentaire donnée a été utilisée comme mesure secondaire de ľefficacité . Une analyse de variance unidirectionnelle ( ANOVA ) et le , test è écarts multiples de Duncan ont démontré que le groupe bupivacaine recevait significativement moins de fentanyl ( p < 0.05 ) dans ľunité des soins postanesthésiques Objective To evaluate the efficacy of injecting 1 % lignocaine into the subserosal aspect of the cornual end of the fallopian tubes to control post‐operative pain after laparoscopic Filshie clip application BACKGROUND Postoperative shoulder-tip pain ( STP ) frequently occurs following laparoscopic surgery . In an attempt to abrogate this complication we prospect ively evaluated the efficacy of intraoperative irrigation of the diaphragm with bupivacaine . METHODS One hundred and five consecutive patients undergoing laparoscopic surgery were prospect ively r and omized to treatment or control groups . Treatment group ( B , n = 55 ) received irrigation with 10 mL 0.5 % bupivacaine in 500 mL saline and control group ( A , n = 50 ) received an equal volume of normal saline . Each dome of the diaphragm was irrigated with 250 mL of either solution at the end of surgery . Laparoscopic procedures performed included cholecystectomy ( n = 63 ) , Nissen fundoplication ( n = 21 ) , appendicectomy ( n = 7 ) , hernia repair ( n = 4 ) , and diagnostic laparoscopy ( n = 10 ) . Patients ' anesthesia and perioperative analgesia were st and ardized . STP was recorded on a visual analogue pain scale ( VAPS ) in the recovery room immediately following surgery and at 4 , 10 , and 24 hours thereafter . RESULTS The overall incidence of STP in patients undergoing laparoscopic procedures was approximately 24 % . Twenty-one patients ( 42 % ) in the control group and 4 patients ( 7 % ) in the treatment group complained of shoulder pain during the recording period ( P = 0.003 ) . Mean STP scores as recorded on VAPS were significantly lower in the bupivacaine group than in the control group from 4 to 24 hours after surgery ( P < 0.01 ) . Postoperative analgesia requirements were also significantly reduced in those patients receiving bupivacaine irrigation ( P < 0.04 ) . CONCLUSION Intraperitoneal irrigation with bupivacaine to both hemidiaphragms at the end of surgery significantly reduces both frequency and intensity of STP following laparoscopic procedures thus reducing patient morbidity Laparoscopy is frequently associated with postoperative shoulder pain that may last several days . We have assessed the analgesic effect of intraperitoneal local anaesthetics during day-case diagnostic laparoscopy . 80 young women were r and omly assigned to one of four groups of 20 patients each : group 1 , no peritoneal administration ; group 2 , 80 ml saline injected under direct vision in the right subdiaphragmatic area at the start of the procedure ; group 3 , 80 ml 0.5 % lignocaine with adrenaline ( 320,000 dilution ) ; group 4 , 0.125 % bupivacaine with adrenaline ( 800,000 dilution ) . Scapular pain was assessed with a visual analogue pain scale , and information about nausea , vomiting , abdominal pain , and analgesic requirements during the first 48 h was sought . Both local anaesthetics were more effective in reducing postoperative shoulder pain than either control or saline . Analgesic requirements were greater in the non-treatment groups than in the local anaesthetic groups . Intraperitoneal local anaesthetic administration during laparoscopy is both a non-invasive and an efficient method of reducing the intensity of scapular pain STUDY OBJECTIVE To evaluate the efficacy of intraperitoneal subdiaphragmatic instillation of 0.5 % lidocaine and 0.5 % bupivacaine infiltration of cannula sites to control pain after diagnostic microlaparoscopy . DESIGN Prospect i ve , r and omized study . ( Canadian Task Force classification I ) . SETTING Day surgery unit of Endogyn Service , Private Endoscopic Associates , Naples , and Department of Gynecologic and Pediatric Sciences , Reggio Calabria University , Catanzaro , Italy . PATIENTS Forty women treated for infertility . INTERVENTIONS The treated group received 0.5 % intraperitoneal subdiaphragmatic lidocaine 40 ml and 0.5 % bupivacaine 5 ml infiltration of cannula insertion sites . The control group received no treatment . In all patients the procedure was performed with atropine 0.5 mg , fentanyl 0.1 mg , droperidol 5 mg , and local anesthesia . Postoperatively , depending on the need , ketoprofene 100 mg or ketorolac 30 mg was administered intramuscularly . MEASUREMENTS AND MAIN RESULTS Postoperative pain score was evaluated by visual analog scale immediately postoperatively and 1 , 3 , 6 , 12 , 24 , 36 , and 48 hours afterward . The treated group had significantly lower pain scores at the end of surgery and at 1- , 3- , ( p < 0.01 ) , and 6-hour intervals ( p < 0.05 ) . No significant differences in scores between groups were observed starting from 6 hours postoperatively . CONCLUSION Postoperative intraperitoneal lidocaine and bupivacaine infiltration of cannula sites offered a detectable benefit to women undergoing diagnostic microlaparoscopy . The effect was temporary , but induced a significant decrease in the postoperative pain for approximately 6 hours Self-reported postoperative pain was reduced significantly ( P less than .05 ) for up to six hours in a group of ambulatory surgical patients with the application of 5 mL of 1 % etidocaine to the b and ed portion of each fallopian tube after laparoscopic tubal ligation with Falope Rings in comparison to a control group receiving normal saline . The etidocaine group had less nausea and vomiting and smaller antiemetic and analgesic requirements than did the control group , though those results were not statistically significant Etidocaine given by intravenous infusion has been compared , using a double-blind technique , with bupivacaine and lignocaine in respect of toxic symptoms and signs . The degree of toxicity is affected considerably by the rate of drug infusion . At 10 mg/min subjects could tolerate twice the dose of etidocaine as bupivacaine . Tolerance to etidocaine was less at 20 mg/min but still compared favourably with bupivacaine at 10 mg/min . Considering the difference in potency of the two agents it was considered that the therapeutic ratios would not be substantially different . Lignocaine at 20 mg/min was better tolerated than etidocaine . Venous plasma concentration during these experiments showed a more rapid decrease in the case of etidocaine compared with bupivacaine , but the concentrations were unhelpful in predicting the toxic effects . Similarly electroencephalography revealed no abnormalities in spite of marked subjective and objective signs of toxicity Although pain after laparoscopic cholecystectomy is less intense than after open cholecystectomy , some patients still experience considerable discomfort . Furthermore , the characteristics of post-laparoscopy pain differ considerably from those seen after laparotomy . Therefore , we investigated the time course of different pain components after laparoscopic cholecystectomy and the effects of intraperitoneal bupivacaine on these different components . Forty ASA physical status grade I-II patients were r and omly assigned to receive either 80 mL of bupivacaine 0.125 % with epinephrine 1/200,000 ( n = 20 ) or the same volume of saline ( n = 20 ) instilled under the right hemidiaphragm at the end of surgery . Intensity of total pain , visceral pain , parietal pain , and shoulder pain was assessed 1 , 2 , 4 , 6 , 8 , 24 , and 48 h after surgery . Analgesic consumption was also recorded . Patient data were similar in the two groups . In the saline group , visceral pain was significantly more intense than parietal pain at each time point ; visceral and parietal pain were greater than shoulder pain during the first 8 h postoperatively . Intraperitoneal bupivacaine did not significantly affect any of the different components of postoperative pain . Analgesic consumption was similar in the two groups . This study demonstrates that visceral pain accounts for most of the pain experienced after laparoscopic cholecystectomy . Intraperitoneal bupivacaine is not effective for treating any type of pain after laparoscopic cholecystectomy . ( Anesth Analg 1995;81:379 - 84 One hundred fifty patients were included in a double-blind study to evaluate whether they were more comfortable being sterilized by fulguration or by Falope-Ring b and ing . They were also studied to see if 4 % Xylocaine applied to the tubes was helpful in decreasing the discomfort with b and ing as it has been shown to be with fulguration . The results confirmed the clinical impression that b and ing is very painful to the patient at the time of application and for the ensuing 24 hours . Although 4 % Xylocaine is very helpful in reducing this discomfort at first , the effect is not lasting . Blood levels of Xylocaine were determined and shown to be well below the accepted toxic level . Fulguration remains the most comfortable form of laparoscopic tubal interruption Objective To evaluate postoperative pain relief of intramuscular ketorolac , topical bupivacaine , and placebo in patients undergoing laparoscopic tubal sterilization with silastic b and s. Methods One hundred five women undergoing laparoscopic tubal sterilization with silastic b and s were r and omized to one of three groups : one received intramuscular ketorolac and topical placebo applied to the fallopian tubes , the second received intramuscular placebo and topical bupivacaine , and the third received intramuscular placebo and topical placebo . Surgical procedures , anesthesia , and recovery were conducted with st and ardized protocol s. Postoperative pain perception was grade d using the modified McGill pain intensity scale at 30 minutes postoperatively , at discharge from the recovery room , and the next morning by telephone interview . Other measured variables included postoperative vomiting , additional analgesia requirement , and length of time spent in the recovery room . Results Only topical bupivacaine was found to decrease postoperative pain scores significantly over those with placebo , at 30 minutes postoperatively ( median score 2 compared with 4 , P = .002 ) and at discharge from the recovery room ( median score 2 compared with 3 , P = .03 ) . There was no significant decrease in pain scores with intramuscular ketorolac compared with placebo . No differences in pain scores were found between the three groups at the next morning phone call . There were no significant differences between the three groups with respect to requirements for supplemental pain medications in the recovery room , incidence of postoperative vomiting , or length of time spent in the recovery room . Conclusion Topical bupivacaine decreases postoperative pain scores significantly compared with placebo in women undergoing laparoscopic tubal sterilization with silastic b and Our objective was to determine if local anesthesia reduces pain after a laparoscopy . Eighty women were assigned r and omly 10 ml of 0.5 % bupivacaine or 0.9 % saline flushed over the peritoneal folds and into the abdominal wall after laparoscopy under general anesthesia . Pain scores from the deep abdomen , skin , shoulder , and back were collected 30 min , 2 h , 4 h , and the day following laparoscopy . Pain scores also were correlated with patients ' height , weight , operative findings , surgical technique and procedure , and volume of gas insufflated into the abdomen . Bupivacaine has a small effect on abdominal and skin pain 2 h after surgery ( p = 0.01 ) but has no effect on shoulder or back discomfort . Women who have been sterilized , have not had previous abdominal surgery , or have evidence of old pelvic inflammation report more postoperative backache and deep abdominal pain but no greater skin or shoulder discomfort . Weight , height , whether the abdominal wall was picked up , and the volume of gas used to insufflate the abdomen are independent of all postoperative pain scores . Local anaesthetic instilled down the laparoscopy trocar reduces skin discomfort 2 h after surgery , but this beneficial effect is small compared with other factors influencing pain after laparoscopy We performed a r and omised controlled study in patients undergoing day case laparoscopic sterilisation to assess whether coating Filshie clips with 2 % lignocaine gel prior to application to the Fallopian tubes would reduce postoperative pain . Sixty‐two patients were studied , in 33 of whom the Filshie clips were coated in sterile 2 % lignocaine gel . Pain scores in the lignocaine gel group were significantly lower than in the control group at 1 h after return to the ward , but no differences were found immediately on return to the ward , or at discharge or at 24 h. There were no significant differences between the two groups in postoperative analgesic requirements or in side effects Although laparoscopic cholecystectomy has rapidly become routine practice in the UK , there has been no rigorous comparison of it with open cholecystectomy . In our trial , 302 patients were r and omised to laparoscopic or minilaparotomy cholecystectomy . Recovery after surgery was assessed by length of hospital stay , outpatient review at 10 days and 4 weeks , and patient question naires 1 , 4 , and 12 weeks after surgery . The mean operation time was 14 min shorter for minilaparotomy , while median post-operative hospital stay was 2 days shorter after laparoscopic cholecystectomy . The hospital costs were about 400 pounds greater for the laparoscopic procedure . Laparoscopic patients returned to work in the home sooner ; at 1 week , they had better physical and social functioning , were less limited by physical problems , and had less pain and depression . At 4 weeks , only physical functioning and depression scores were better in the laparoscopic group , and by 3 months there were no differences . Laparoscopic patients were more satisfied with the appearance of their scars . The incidence of complications after both procedures was 20 % . Compared to minilaparotomy cholecystectomy , laparoscopic cholecystectomy results in shorter hospital stay , less postoperative dysfunction , and quicker return to normal activities , but is more costly We have studied the effect of ropivacaine for combined port site and mesosalpinx infiltration , and peritoneal instillation on pain , nausea and vomiting after laparoscopic sterilization , in a double-blind , placebo-controlled study in 80 patients . The total dose of ropivacaine was 285 mg . All patients received intra- and postoperative NSAID in fixed doses . Abdominal and shoulder pain , nausea and vomiting were recorded during the first 8 h after operation and in a diary for 3 days . In the ropivacaine group , abdominal pain scores were lower during the first 4 h ( P < 0.00001 ) , additional use of morphine was less ( P < 0.001 ) and fewer patients had nausea or vomiting during the first 72 h ( five vs 14 ; P < 0.05 ) . There were no signs of local anaesthetic toxicity The effect of intraperitoneal bupivacaine on postoperative pain was studied in 60 ASA 1–2 patients undergoing elective laparoscopic cholecystectomy . The patients were r and omly selected ( 20 patients in each group ) to receive in double‐blind fashion 100 ml of either plain 0.15 % bupivacaine { 150 mg · 100 ml‐1 ) or the same solution with adrenaline ( 1.5 μg ml‐l ) , or the same volume of saline into the right subdiaphragmatic space at the end of surgery . The patients were kept in the Trendelenburg 's position for 20 min after the instillation . Venous blood sample s for the determination of bupivacaine plasma concentrations were drawn up to 180 min . Plasma bupivacaine concentrations peaked at 30 min ( highest individual value 2.6 μg ml‐1 ) after instillation . Bupivacaine concentrations were significantly lower in the bupivacaine‐adrenaline group . During the follow‐up no difference between the groups occurred as to the time to first dem and of analgesia , severity of postoperative pain , amount of consumed analgesics during 7 days , and length of hospitalization . In all groups , 30–45 % of the patients complained of right shoulder pain . After the first 24 hours , pain at rest and during moving was reported as mild and was managed with oral ketoprofen Local anesthetics decrease postoperative pain when placed at the surgical site . Patients benefit from laparoscopic extraperitoneal hernia repair because this allows earlier mobilization than the more classical open surgical approach . The purpose of this study was to determine the pain-sparing efficacy of local anesthetics placed in the preperitoneal fascial plane during extraperitoneal laparoscopic inguinal hernia surgery . Forty-two out patients were included in a double-blind , r and omized , placebo-controlled , institutional review board-approved study . At the conclusion of a st and ardized general anesthetic , 21 patients received 60 mL of 0.125 % bupivacaine into the preperitoneal fascial plane before incisional closure , whereas the other 21 patients received 60 mL of the isotonic sodium chloride solution placebo . Postoperative pain was assessed 1 , 4 , 8 , 24 , and 72 h postoperatively . In addition , postoperative fentanyl and outpatient acetaminophen 500 mg/hydrocodone 5 mg requirements were recorded . All hernia repairs were performed by the same surgeon . Appropriate statistical analyses were used . There were no significant differences between the bupivacaine and isotonic sodium chloride solution groups with regard to postoperative pain scores , length of postanesthesia care unit stay , or analgesic requirements . Furthermore , neither unilateral versus bilateral repair nor operative time affected the measured parameters . The addition of 60 mL of 0.125 % bupivacaine into the preperitoneal fascial plane during extraperitoneal laparoscopic hernia repair did not significantly alter pain scores , supplementary analgesic requirements , or recovery room length of stay . Implication s : The placement of 60 mL of 0.125 % bupivacaine into the preperitoneal fascial plane during extraperitoneal laparoscopic hernia repair did not significantly alter pain scores , supplementary analgesic requirements , or recovery room length of stay . ( Anesth Analg 1998;87:377 - 81 Background The effects of intraperitoneal administration of bupivacaine on pain after laparoscopic cholecystectomy were studied in a prospect i ve , double‐blind , r and omised trial . Methods : Eighty ASA 1 and 2 patients were r and omly assigned to one of two groups . Immediately after pneumoperi‐toneum was obtained patients in group 1 were given 15 ml of 0.5 % bupivacaine injected under direct vision into the hepato‐diaphragmatic space , near and above the hepato‐duodenal ligament and above the gallbladder . At the end of operation another 15 ml of bupivacaine was injected . Patients in group 2 were given 15 ml of 0.9 % saline solution in a similar fashion . Postoperative pain was assessed using a visual analogue scale ( VAS 100 mm ) at 0.5,4 , 8,12 and 24 h after surgery . Analgesic consumption was also recorded Central to high quality day-case care is the provision of good analgesia with minimal side effects . The success of laparoscopic sterilisation as a day case procedure may be hampered by severe post-operative pain1 . Opioid drugs have a poor side effect profile ; a reduction in their use should contribute significantly to patient care . Local anaesthetic blocks used to improve post-operative pain relief after laparoscopic sterilisation include combined rectus sheath and mesosalpinx block2 , but an extra surgical procedure is involved . Small volumes of concentrated bupivacaine applied directly to the fallopian tubes are safe and effective3 . Since pain after laparoscopic sterilisation may arise from manipulation of pelvic organs during visualisation of the fallopian tubes , as well as from the direct application of Filshie clips , this study was design ed to assess the analgesic effect , as measured by visual analogue scores for pain and post-operative analgesic requirements , of a large volume of dilute bupivacaine instilled into the pelvic peritoneal cavity Sixty women having laparoscopic sterilisation performed under general anaesthesia were r and omly allocated to one of two groups . Intraoperatively , one group had bupivacaine applied topically to the fallopian tubes and injected into the skin wounds , while the other group received no local anaesthetic . A double-blind investigation utilising a visual analogue scale failed to demonstrate a statistically significant difference in postoperative pain between the two groups . In both groups there was a significant reduction in mean pain scores between 1/2 and 7 hours , but there was no further reduction between 7 hours and 17 hours . At 7 hours , only 10 % of patients scored their pain as 3 or greater ( out of a possible 10 ) . It is concluded that the use of bupivacaine as described is not a useful adjuvant to general anaesthesia and that the low incidence of even moderate pain at 7 hours confirms the view that these patients are suitable for management in the day-stay unit A study of 300 women undergoing sterilization via st and ard or open laparoscopy was conducted at Siriraj Hospital in Bangkok , Thail and ; one aspect of the study was design ed to determine whether application of topical anesthesia to the fallopian tubes reduces the degree of pain experienced by the patient . The use or nonuse of topical anesthesia was r and omized for all cases . Overall , data from this study indicate that application of topical anesthesia to the fallopian tubes tends to diminish surgical pain of patients sterilized by use of either the st and ard laparoscopy or the open laparoscopy approach and that pain in the recovery period is also reduced for open laparoscopy patients Pain during tubal sterilisation is thought to be due to either ischaemia or pressure at the site of impact of sterilising devices on the fallopian tubes . We have evaluated the effectiveness of an application of 2 % lignocaine gel to Filshie clips to relieve postoperative pain . In a r and omised double-blind placebo-controlled study , 80 healthy women undergoing tubal sterilisation under general anaesthesia at the County Hospital , Lincoln , UK , were allocated to be sterilised by Flishie clips covered with 2 % lignocaine gel or K-Y gel as placebo . Pelvic pain was assessed , with a 100 mm visual analogue scale , at 1 hour , at hospital discharge , and time of first analgesia or any other time analgesia was dem and ed . The lignocaine-treated group had significantly longer time to first analgesia , less pain at 1 hour , less nausea and vomiting , and shorter recovery time . Fewer lignocaine-treated patients needed additional analgesia and they required fewer opioids . There was no case of failed sterilisation or adverse reaction to lignocaine . The application of local anaesthetic gel to Filshie clips is a safe , non-invasive , and effective method of relieving postoperative pain during laparoscopic tubal sterilisation Although postoperative pain following laparoscopic cholecystectomy ( LC ) is less intense than that after open surgery , postoperative morbidity nonetheless increases with LC . The aim of this study was to investigate whether local anesthetic infiltration of trocar sites during LC decreased postoperative pain and , if so , to find the optimum timing for local anesthesia ( LA ) . Seventy patients undergoing LC were r and omized into three groups . In the first ( control group , n = 25 ) 3 ml of 0.9 % NaCl was subcutaneously infiltrated around each 5-mm trocar site , 4 ml around each 10-mm site . In the second group ( n = 20 ) , the same volume of local anesthetic was administered in the same manner prior to surgery , and in the third group ( n = 25 ) an identical dose of local anesthetic was infiltrated at the end of surgery . A visual analog scale was given to all patients , who were asked to record their pain intensity at 1 , 3 , 5 , 7 , and 12 h postoperatively . Pethidine HCl 1 mg/kg i.m . was given to those whose pain intensities were greater than 5 . The mean pain intensities were 7.6 , 5.9 , and 5.1 in the control , preoperative , and postoperative LA groups , respectively . In the preoperative LA group , 50 % of patients and in the postoperative LA group 28 % of patients required analgesics compared with 76 % in the control group . The main pain intensities and analgesic requirements were significantly lower in the postoperative LA group compared with other groups . We conclude that local anesthesia during LC reduces postoperative pain and that infiltration of trocar sites following surgery offers better pain relief than local anesthetic given just before the incision Objective To determine whether preoperative ketoprofen and mesosalpinx infiltration , either alone or in combination , favorably influence postoperative recovery after outpatient laparoscopic sterilization . Methods In a double-blind , r and omized , placebo-controlled study , 20 women received 100 mg of oral ketoprofen preoperatively , and each mesosalpinx was infiltrated with 5 mL of saline plus epinephrine 1:200,000 ; 20 women were given oral ketoprofen , and each mesosalpinx was infiltrated with 5 mL of bupivacaine 0.5 % with epinephrine 1:200,000 ; and 20 women received a placebo capsule with mesosalpinx infiltration . Pain was assessed by a visual analogue scale and a self- assessment 11-point scale ; outcome was assessed by discharge time , consumption of analgesics , incidence of nausea and vomiting , and the number of postoperative days to full recovery . Results Pain ratings in the ketoprofen-only group were significantly higher than in the two other groups ( P < .001 ) . Preoperative ketoprofen alone provided insufficient postoperative pain relief , necessitating the use of opiates and peripheral analgesics . Nausea and vomiting were highest in these subjects , as was intake of peripheral analgesics at home . Times to discharge were also the longest in this group ( median 385 minutes , range 260 - 510 ) and differed significantly from both other groups ( P < .001 ) . It took 4 - 13 days to recover . In contrast , women with only a mesosalpinx block ambulated and recovered sooner , but times to discharge were still prolonged ( median 240 minutes , range 105 - 375 ) . Recovery usually occurred by the fourth postoperative day . The combination of preoperative ketoprofen and mesosalpinx block result ed in the shortest times to discharge ( median 190 minutes , range 80 - 330 ) , the least consumption of peripheral analgesics , and the lowest incidence of nausea and vomiting . Recovery occurred by the fourth postoperative day . Conclusion Mesosalpinx infiltration has a favorable effect on postoperative recovery after day-surgery laparoscopic sterilization . Still better results can be obtained with a multimodal analgesic approach , combining mesosalpinx infiltration with preoperative ketoprofen Conflicting reports exist in the literature on the effectiveness of topical local anesthetic applied to the serosal surface of the fallopian tubes for the control of immediate postoperative pain after mechanical ( b and or clip ) tubal ligation . Sixty-four patients were studied prospect ively during outpatient laparoscopic Falope ring tubal ligation using the modified McGill Present Pain Intensity Scale . Patients r and omly assigned to four groups received topical bupivacaine hydrochloride on both fallopian tubes , the right tube only , or the left tube only , or received none ( controls ) . A unique study design was incorporated which allowed the untreated fallopian tube to serve as a within-subject control for each patient receiving unilateral treatment . Statistical analysis confirmed significant benefit when both fallopian tubes were treated as compared with no treatment ( P less than .05 ) . There was also consistent evidence of decreased immediate postoperative pain perception on the treated side for patients receiving unilateral treatment . The value of topical bupivacaine was demonstrated by both subjective patient response ( McGill Pain Scale ) and reduced need for pain medication before outpatient discharge . Our data support the value of topical bupivacaine applied to the serosal surface of the fallopian tubes for the reduction of postoperative pain after outpatient laparoscopic mechanical ( b and or clip ) tubal ligation Laparoscopic cholecystectomy is now widely practised . There are various methods of pain relief used but none has been assessed or compared following this procedure . We have assessed the analgesic effect of intraperitoneal bupivacaine in laparoscopic cholecystectomy . Sixty consecutive patients were r and omly assigned to one of two groups . Patients in group 1 were given 20 ml of saline injected under vision into the region of the gallbladder bed . Patients in group 2 were given 20 ml of 0.25 % bupivacaine in a similar fashion . Postoperative pain was assessed with a visual analogue pain scale and the site of pain was recorded . Patients in the bupivacaine group had less pain in the early postoperative period and a lower incidence of pain in the right hypochondrium . Intraperitoneal bupivacaine is a simple and effective treatment for postoperative pain after laparoscopic cholecystectomy Objective : To test the effectiveness of intraperitoneal local anesthesia in relieving postoperative pain after laparoscopic sterilization . Methods : In a double-blind , placebo-controlled r and omized study of two groups of 25 subjects each , women scheduled for tubal sterilization under general anesthesia received 80 mL of 0.5 % lidocaine with 1/320,000 epinephrine intraperitoneally in the right subdiaphragmatic quadrant at the beginning of the procedure . At the end of the procedure , they received 10 mL of 2 % lidocaine with 1/80,000 epinephrine injected into each mesosalpinx . Controls received saline instead of lidocaine . Shoulder and pelvic pain assessed by visual analogue pain scale , postoperative analgesic requirements , nausea or vomiting , and time to return to normal daily activities were evaluated in the ambulatory unit and after discharge during the first 48 postoperative hours . Blood sample s were taken in ten subjects receiving lidocaine to evaluate peak plasma concentrations and time to peak plasma concentrations . Results : Pain was significantly less in patients who received lidocaine , and the difference lasted for the duration of the study ( P<.05 ) . Analgesic requirements and time to return to normal daily activities were significantly reduced in patients who received lidocaine ( P<.05 ) . Blood sample s revealed no toxic concentrations . The peak plasma concentration was 3.22 ± 1.21 µg/mL , and the time to peak plasma concentration was 42 ± 15 minutes . Conclusion : Intraperitoneal instillation of lidocaine-epinephrine combined with mesosalpinx infiltration of lidocaine during tubal sterilization produces effective , longlasting analgesia and improves the postoperative course A prospect i ve r and omized trial was performed to determine whether local anaesthetic solutions injected into the preperitoneal space may provide additional pain relief following transabdominal preperitoneal laparoscopic hernia repair Thirty patients scheduled to undergo laparoscopic sterilisation were allocated at r and om to receive either a st and ardised general anaesthetic and rectus sheath block ( group A ) , or st and ardised general anaesthetic combined with both rectus sheath and mesosalpinx blocks ( group B ) . Group B patients had significantly less postoperative pain , as assessed by linear analogue scores ( p < 0.025 ) , and analgesic requirement ( p < 0.05 ) . By the 8th postoperative hour all 15 group B patients had been discharged from hospital , whilst only seven of 15 patients in group A were considered suitable for discharge at this time , ( p < 0.05 ) Although postoperative pain has been reduced significantly since the advent of laparoscopic surgery , many patients still complain of moderate abdominal and shoulder pain during the first 48 to 72 h after surgery . In this study , the effect of subdiaphragmatic instillation of bupivacaine after laparoscopic cholecystectomy was investigated . The evaluation of postoperative pain was done according to a numerical verbal scale and the dose of analgesia required . The results showed a considerable reduction of postoperative pain during the first 48 h after surgery in patients who received bupivacaine instillation . Although the literature shows certain controversy as to the effects of similar methods , our study concludes that instillation of a long-acting anesthetic , such as bupivacaine , into the subdiaphragmatic space after laparoscopic procedures is effective in postoperative pain reduction UNLABELLED Pain is the dominant complaint after laparoscopic cholecystectomy . No study has examined the combined effects of a somato-visceral blockade during laparoscopic cholecystectomy . Therefore , we investigated the effects of a somato-visceral local anesthetic blockade on pain and nausea in patients undergoing elective laparoscopic cholecystectomy . In addition , all patients received multi-modal prophylactic analgesic treatment . Fifty-eight patients were r and omized to receive a total of 286 mg ( 66 mL ) ropivacaine or 66 mL saline via periportal and intraperitoneal infiltration . During the first 3 postoperative h , the use of morphine and antiemetics was registered , and pain and nausea were rated hourly . Daily pain intensity , pain localization , and supplemental analgesic consumption were registered the first postoperative week . Ropivacaine reduced overall pain the first two hours and incisional pain for the first three postoperative hours ( P < 0.01 ) but had no apparent effects on intraabdominal or shoulder pain . During the first 3 postoperative h , morphine requirements were lower ( P < 0.05 ) , and nausea was reduced in the ropivacaine group ( P < 0.05 ) . Throughout the first postoperative week , incisional pain dominated over other pain localizations in both groups ( P < 0.01 ) . We conclude that the somato-visceral local anesthetic blockade reduced overall pain during the first 2 postoperative h , and nausea , morphine requirements , and incisional pain were reduced during the first 3 postoperative h in patients receiving prophylactic multi-modal analgesic treatment . IMPLICATION S A combination of incisional and intraabdominal local anesthetic treatment reduced incisional pain but had no effect on deep intraabdominal pain or shoulder pain in patients receiving multimodal prophylactic analgesia after laparoscopic cholecystectomy . Incisional pain dominated during the first postoperative week . Incisional infiltration of local anesthetics is recommended in patients undergoing laparoscopic cholecystectomy |
1,333 | 23,497,257 | Conclusions A systematic review of PRO study results showed both the MOS-HIV and EQ-5D were responsive to changes between groups and /or over time in treatment-naïve HIV-infected patients .
These instruments may be used either individually or together in clinical trials to measure changes in HRQL | Background Selection of an appropriate patient-reported outcome ( PRO ) instrument for a clinical trial requires knowledge of the instrument ’s responsiveness to detecting treatment effects .
The purpose of this study was to examine the responsiveness of two health-related quality of life ( HRQL ) instruments used in clinical trials involving HIV-infected adults : the HIV-targeted Medical Outcomes Study HIV Health Survey ( MOS-HIV ) , and a generic measure , the EuroQol-5D ( EQ-5D ) . | Objective : Investigation on anxiety , stress , depression , and quality of life ( QoL ) within STACCATO , a r and omised trial of two treatment strategies : CD4 guided scheduled treatment interruption ( STI ) compared to continuous treatment ( CT ) . Participants : Thai patients with HIV-infection enrolled in the STACCATO trial . Methods : Anxiety , depression assessed by the question naires Hospital Anxiety and Depression Scale ( HADS ) and DASS , stress assessed by the Depression Anxiety Stress Scale ( DASS ) , and QoL evaluated by the HIV Medical Outcome Study ( MOS-HIV ) question naires . Answers to question naires were evaluated at 4 time-points : baseline , 24 weeks , 48 weeks and at the end of STACCATO . Results : A total of 251 patients answered the HADS/DASS and 241 answered the MOS-HIV of the 379 Thai patients enrolled into STACCATO ( 66.2 and 63.6 % respectively ) . At baseline 16.3 % and 7.2 % of patients reported anxiety and depression using HADS scale . Using the DASS scale , 35.1 % reported mild to moderate and 9.6 % reported severe anxiety ; 8.8 % reported mild to moderate and 2.0 % reported severe depression ; 42.6 % reported mild to moderate and 4.8 % reported severe stress . We showed a significant improvement of the MHS across time ( p=0.001 ) , but no difference between arms ( p=0.17 ) . The summarized physical health status score ( PHS ) did not change during the trial ( p=0.15 ) nor between arm ( p=0.45 ) . There was no change of MHS or PHS in the STI arm , taking into account the number of STI cycle ( p=0.30 and 0.57 ) but MHS significant increased across time-points ( p=0.007 ) . Conclusion : Antiretroviral therapy improved mental health and QOL , irrespective of the treatment strategy BACKGROUND Zidovudine , the first antiretroviral agent , has short-term haematological toxicity . However , it is unclear whether patients tolerating long-term zidovudine-containing regimens will benefit from a switch to non-zidovudine-containing regimens . METHODS One hundred and fifty-eight patients enrolled in the ALIZE trial receiving zidovudine at baseline were analysed . These patients were r and omized to continue their regimen or to switch to a combination of emtricitabine , didanosine and efavirenz for 48 weeks . Changes from baseline in haemoglobin ( Hb ) , neutrophil and platelet counts were compared between arms as well as the occurrence of cardiovascular events , bacterial infections , use of haematopoietic growth factors , blood transfusion and quality of life using the Medical Outcome Study HIV ( MOS-HIV ) health survey . RESULTS Eighty-one patients continued their regimen and 77 switched . At 48 weeks , mean change from baseline in Hb were + 0.73 and -0.37 g/dL in the switch and maintenance groups , respectively ( P < 0.01 ) . Mean neutrophil counts increased by 592 and 51 cells/mm(3 ) in the switch and maintenance groups , respectively ( P = 0.02 ) . The occurrence of cardiovascular events or bacterial infections was similar in both treatment arms with no use of haematopoietic growth factors or blood transfusion . Also , mean change from baseline in MOS-HIV physical and mental health summary scores was similar in both arms . CONCLUSIONS A switch from a long-st and ing zidovudine- to a non-zidovudine-containing regimen modestly improves haematological parameters and is not associated with obvious clinical benefit Anemia , a common hematological abnormality in HIV , contributes to decreased quality of life ( QOL ) . This study assessed once-every-2-week epoetin alfa on maintaining QOL and hemoglobin ( Hb ) in anemic HIV-infected patients in a 24-week , open-label , multicenter study . HIV-infected patients ( Hb < or = 12 g/dl ) received epoetin alfa 40,000 units subcutaneously once weekly , until reaching Hb > or = 13 g/dl . Patients then entered a maintenance phase ( MP ) , in which epoetin alfa was administered every other week or at longer intervals . The trial objectives were to determine if QOL , as measured by the Medical Outcomes Study -HIV ( MOS-HIV ) general health perceptions ( GHP ) domain and Hb , was maintained . Safety was also assessed . A total of 292 patients were enrolled ( 72 % on HAART ) . Mean baseline laboratory values were Hb = 10.8 g/dl , CD4(+ ) count = 280 cells/microl , and HIV RNA = 51,867 copies/ml . In all , 81 % of patients reached Hb > or = 13 g/dl and 92 % reached Hb > or = 12 g/dl . QOL was maintained from the beginning ( GHP = 44.2 points ) to the end of MP ( GHP = 43.4 points ) with every other week or longer dosing . Mean Hb at the beginning of MP was 13.4 + /- 0.5 g/dl and was 12.8 + /- 1.4 g/dl at study end . Epoetin alfa was well tolerated ; adverse events were consistent with those reported in previous studies of epoetin alfa in HIV-infected patients . Although the clinical approach tested in this study is not consistent with current prescribing recommendations , the results confirm the efficacy of prolonged dosing intervals ( every 2 - 4 weeks ) in maintaining optimal Hb levels and QOL in anemic HIV-infected patients BACKGROUND Antiretroviral therapy including tipranavir boosted with ritonavir ( TPV/r ) has shown superior viral suppression and immunological response compared with comparator ritonavir-boosted protease inhibitor ( CPI/r ) regimens in treatment-experienced HIV-1-infected patients . This study assesses the influence of adverse events ( AEs ) on health-related quality of life ( HRQOL ) and change in HRQOL in patients treated with TPV/r versus CPI/r regimens . METHODS Changes in HRQOL over 48 weeks were assessed using Medical Outcomes Study HIV Health Survey ( MOS-HIV ) data combined from two r and omized , open-label , Phase III studies ( RESIST-1 and RESIST-2 ) . Generalized estimating equations ( GEE ) were used to compare physical health and mental health summary scores and 10 subscale scores , and to compare scores of patients with and without AEs . To compare AE incidences in the two treatment groups , AEs were exposure-adjusted . RESULTS There were 984 patients in the HRQOL analysis . AE occurrence and severity result ed in significantly lower MOS-HIV scores across both treatment arms ( P<0.05 ) . Overall incidence of AEs was higher in the CPI/r versus TPV/r group ( 562.8 versus 514.4 per 100 patient-exposure years ) ; treatment-related AEs were more frequent in the TPV/r group ( 75.0 versus 56.6 per 100 patient-exposure years ) . HRQOL was maintained in patients on TPV/r over 48 weeks of treatment across all summary and subscale scores . Compared with CPI/r , TPV/r was associated with a significant but small ( SD<0.2 ) improvement in pain scores ( + 4.8 points ; P<0.05 ) . CONCLUSIONS HRQOL was maintained across both summary and all subscale scores from baseline to 48 weeks in the TPV/r and CPI/r treatment arms , despite the incidence of treatment-related AEs Objective : To examine the effect of repeated , long-cycle structured intermittent versus continuous HAART on health-related quality of life ( HRQL ) and symptom distress in patients with chronic HIV infection and plasma HIV RNA of less than 50 copies/ml . Design : Prospect i ve survey of adult patients ( n = 46 ) enrolled in a r and omized clinical trial evaluating intermittent versus continuous HAART on immunological and virologic parameters . Patients ( n = 23 ) r and omized to structured intermittent therapy received serial cycles of 4 weeks on/8 weeks off HAART . Outcome measures : HRQL was measured by the physical and mental health summary scores of the Medical Outcomes Study HIV Health Survey ( MOS-HIV ) . Symptom distress was measured by the Symptom Distress Scale . Patients completed initial question naires prior to r and omization and at weeks 4 , 12 , and 40 of the trial via a touch screen computer in an outpatient clinic . Results : Baseline demographic and clinical characteristics were equivalent in both treatment groups . Although the mental health summary score declined significantly over time for the structured intermittent group , linear mixed modeling ANOVA indicated no significant difference across time for MOS-HIV summary and Symptom Distress Scale scores between the two treatment arms . Conclusion : In this small sample , repeated long-cycle structured intermittent therapy may not provide HRQL or symptom distress advantage compared to continuous HAART in patients with chronic HIV infection over 10 months of treatment . Further research in a heterogenous chronic HIV population and longer follow-up period is warranted Objective : To investigate the relative magnitude and duration of impact of AIDS-defining events ( ADEs ) and non-AIDS serious adverse events ( SAEs ) on health-related quality of life ( HRQoL ) among patients with advanced HIV/AIDS . Methods : We use data from OPTIMA ( OPTions In Management with Antiretrovirals ) , a multinational , r and omized , open , control , clinical management trial of treatment strategies for patients with multidrug-resistant HIV and advanced immune disease . Longitudinal models were used to determine the effects of ADEs and SAEs on HRQoL across periods before , during , and after event onset . The Medical Outcomes Study HIV Health Survey ( MOS-HIV ) physical and mental health summary scores ( MOS-PHS and MOS-MHS ) , EQ-5D , and the Health Utilities Index Mark 3 HRQoL measures were all assessed at regular follow-up intervals during the trial . Results : ADEs occurred much less frequently than SAEs ( n = 147 vs. n = 821 ) in the study sample population of 368 patients , during median follow-up of 3.96 years . Although both ADEs and SAEs had significant negative impacts on HRQoL , SAEs had at least as large an impact upon HRQoL as ADEs when both were included in a multivariate linear regression model , controlling for other covariates . However , the effect of ADEs on HRQoL was more persistent , with larger magnitude of effect across all instruments in time intervals further from the onset of the event . Conclusions : Non-AIDS SAEs occurring in patients with late-stage HIV/AIDS seem to have at least as important an immediate impact on patient HRQoL as ADEs ; however , the impact of ADEs seems to be more persistent . Our findings call for a greater emphasis on the detection and active prevention of non-AIDS SAEs in patients with late-stage HIV/AIDS This 6-month r and omized controlled trial evaluated the impact on quality of life ( QOL ) of a medication reminder device for patients with HIV . Patients were eligible if they had taken three or fewer highly active antiretroviral therapy ( HAART ) regimens or were treatment naïve . The intervention group received the Disease Management Assistance System ( DMAS ) , a prompting device that verbally reminds patients at medication times and electronically records doses , and a monthly 30 minute adherence educational session . Controls received education only . QOL was measured at baseline and 6 months using the Centers for Epidemiologic Studies Depression Scale ( CES-D ) , Instrumental Activities of Daily Living ( IADLs ) , and the Medical Outcomes Study HIV Health Survey ( MOS-HIV ) . At baseline , 62 patients completed surveys ( 31 control , 31 DMAS ) ; at month 6 , 48 patients completed surveys ( 23 control , 25 DMAS ) . At month 6 , controls had improved QOL scores for CES-D , IADLs , physical health , general health , pain , QOL , and role functioning , while participants in the DMAS arm had some deterioration in QOL scores . These differences persisted after controlling for demographics , baseline CD4 , and adherence . DMAS was associated with improved adherence but decreased QOL OBJECTIVES Treatment advances have transformed human immunodeficiency virus/acquired immune deficiency syndrome ( HIV/AIDS ) into a chronic manageable disease ; quality of life ( QoL ) has become an important health outcome . Some studies have shown the individual effects of acupuncture and the relaxation response ( RR ) in improving QoL of patients with HIV/AIDS . In light of the presumed shared features of acupuncture and the RR , we conducted a pilot study to examine the effects of adding the RR to usual acupuncture treatment on improving the QoL of HIV/AIDS patients . DESIGN Two-arm double-blind r and omized controlled trial . SETTING S/LOCATION AND SUBJECTS : We enrolled 119 patients with HIV/AIDS ( mean age 46 years , 85 % male ) who had at least 1 of the highly prevalent HIV-related symptoms and who were receiving acupuncture treatment in an acupuncture clinic in Boston , MA . INTERVENTION We r and omized patients into intervention ( N = 58 ) and control ( N = 61 ) groups . All participants received individualized acupuncture treatments prescribed by their acupuncturists . While receiving acupuncture treatment , the intervention group wore earphones to listen to tapes with instructions to elicit the RR followed by soft music that was routinely played in the clinic ; the control group listened only to soft music . OUTCOME MEASURES Three ( 3 ) QoL scales : the Medical Outcomes Study HIV health survey , the Functional Assessment of HIV Infection , and the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being , measured at baseline , 4-week , 8-week , and 12-week follow-ups . RESULTS At the 12-week follow-up , the intervention group showed significant improvements in emotional ( p = 0.0002 ) , spiritual/peace ( p = 0.02 ) , physical ( p = 0.003 ) and mental health ( p = 0.0003 ) QoL from baseline . Results of mixed effects regression models indicated linear trends of improvement over time in these dimensions of QoL for the intervention group ( p < 0.02 ) . In the control group , the only significant improvement was observed in the emotional QoL ( p < 0.01 ) . The intervention group showed trends of greater improvements than the control group ( p = 0.07 for 12-week physical health QoL ) . CONCLUSIONS Data from this pilot trial suggested that adding the RR to acupuncture may enhance improvement in QoL of patients with HIV/AIDS . Further investigation on this putative synergistic effect is warranted Abstract While many AIDS patients in sub-Saharan Africa are receiving antiretroviral treatment ( ART ) via public clinics , improvements in health status also depend on socioeconomic and psychological factors and quality of healthcare services . Inter-dependence between patients ’ clinical markers and quality of life indicators should be analyzed using comprehensive models . This longitudinal study compiled socioeconomic and clinical variables at six monthly intervals on patients receiving ART in South Africa ; patients ’ ratings of quality of services and staff in “ Assessment ” and “ Treatment ” sites were assessed . Dynamic r and om effects models were estimated by maximum likelihood for CD4 cell counts and for quality of life indices ( EQ-5D and Visual Analogue Scale ) , incorporating the inter-dependence between plasma HIV RNA levels and CD4 cell counts . The results showed that emotional support received by patients was a significant predictor ( P<0.05 ) of CD4 cell counts and quality of life indices . Ratings of services and staff in Assessment and Treatment sites were significantly associated with CD4 cell counts and quality of life indices ; CD4 cell count was a significant predictor of quality of life indices . The results indicated that it is important to compile socioeconomic and psychological variables for AIDS patients and monitor healthcare services for improving their health status and quality of life Objective : Brief utility measures are needed in clinical trials in addition to existing descriptive measures of health-related quality of life ( HRQOL ) . We examined the reliability and validity of the EuroQol ( EQ-5D ) and MOS-HIV and their responsiveness to HIV-related clinical events . Methods : Subjects with advanced HIV disease ( CD4 < 100 ) were enrolled in a r and omized trial for CMV prophylaxis ( n = 990 ) . The EQ-5D includes a weighted sum of five domains ( EQ-5D Index ) and a visual analog scale ( EQ-VAS ) . The MOS-HIV has 10 subscales and physical ( PHS ) and mental health summary scores ( MHS ) . Construct validity of the EQ-5D was tested based on hypothesized relationships to subscales of the MOS-HIV . Relative precision and responsiveness to adverse experiences and opportunistic infections ( OIs ) were compared for the two instruments . Results : Mean age of the patients was 38 , 94 % were male , 80 % white , and 7 % had injected drugs . Mean baseline scores for EQ-5D Index and EQ-VAS were 0.80 and 76.0 , respectively , 28 and 4 % reported maximum scores . Mean MOS-HIV subscales score ranged from 55 ( role ) to 84 ( cognitive ) ; mean PHS and MHS were 47.4 and 49.5 , respectively . Correlations between MOS-HIV subscales and EQ-5D Index ranged from 0.45 ( role ) to 0.63 ( pain ) ; correlations with EQ-VAS ranged from 0.33 ( cognitive ) to 0.66 ( health perceptions ) . Correlations between MOS-HIV PHS and MHS with EQ-5D Index were 0.61 and 0.58 ; and with EQ-VAS , 0.57 and 0.60 , respectively . Responsiveness to adverse experiences was highest for MOS-HIV pain and PHS ( effect sizes = 0.9 and 0.4 ) ; pain had the highest relative precision ( 2.4 ) for adverse experiences ; EQ-VAS had the greatest relative precision ( 1.6 ) for developing an OI . Conclusion : In these patients with advanced HIV disease , EQ-5D showed good construct validity , but there may be a ceiling effect for its EQ-5D Index component . EQ-5D was less responsive to adverse events than the MOS-HIV . However , the EQ-VAS was most sensitive to developing an OI and is likely to be a useful measure of HRQOL for generating QALYs in cost-utility studies involving patients with advanced HIV disease Abstract We examined trends and predictors of quality of life ( QOL ) over 12 months among a prospect i ve cohort of 947 HIV-1-infected adults initiating highly active antiretroviral therapy ( HAART ) between May 2003 and May 2004 in rural Ug and a. Participants provided clinical , demographic and psychosocial data at baseline and every three months thereafter . Outcome measures included physical and mental health summary scores based on the Medical Outcomes Study -HIV Health Survey ( MOS-HIV ) . Generalised estimating equations were used to assess magnitude of change in summary scores and factors associated with QOL . Of 710 women and 237 men enroled , the mean age was 38.7 years and mean baseline CD4 cell count was 124.1 cells/µL. At enrolment , physical and mental health summary scores were 39.2 and 40 , respectively . By 12 months of HAART , scores increased by 11.2 points ( p < 0.001 ) and 7.4 points ( p < 0.001 ) , respectively . For both scores , most gains were achieved by the third month of therapy . While several clinical , psychosocial and sociodemographic factors predicted QOL at HAART initiation , financial dependence on others was the only remaining predictor after controlling for time on HAART . Interventions to enhance the economic and employment opportunities of patients taking HAART in rural Africa may help maximise gains in QOL Abstract Purpose : Adverse effects are important determinants of quality of life ( QOL ) during highly active antiretroviral therapy ( HAART ) . The PLATO study investigated the association between changes in patient-reported outcomes including QOL and substitution with lopinavir/ritonavir in patients experiencing side effects ( SEs ) . Method : HIV–1–infected participants ( N = 849 ) with undetectable viral load experiencing Grade -2 SEs of the protease inhibitor ( PI ) or nonnucleoside reverse transcriptase inhibitor ( NNRTI ) component of their HAART regimen were r and omized to immediate ( baseline ) or deferred ( week 4 ) substitution with lopinavir/ritonavir soft-gel capsules 400/100 mg bid . The primary endpoint was change in the total score from the AIDS Clinical Trials Group ( ACTG ) Symptoms Distress Module ( ASDM ) , supplemented with two items for nephrolithiasis . Secondary endpoints included Medical Outcomes Study (MOS)-HIV scores and Center for Epidemiologic Studies –Depression ( CES-D ) scores . Results : Immediate substitution result ed in improved ASDM total score at week 4 compared with deferred substitution ( p < .001 ) and significant improvements in all MOS-HIV domains , while significant improvement was observed in CES-D scores at week 8 . Primary SEs resolved at week 8 in 65 % of participants in the immediate substitution group . Suppression of HIV-1 was maintained . Treatment was well-tolerated and associated with elevations in cholesterol and triglycerides . Conclusion : Substitution with LPV/r improved patient-reported outcomes including QOL in patients experiencing Grade -2 SEs , while maintaining viral suppression Abstract Purpose : Use of enfuvirtide-containing regimens leads to virologic and immunologic benefits and quality of life ( QoL ) improvements . This study ( QUALITÉ ) was design ed to primarily identify baseline predictors of QoL improvements and characterize injection site reaction ( ISR ) signs/symptoms using a thinner/shorter needle . Method : Enfuvirtide-naïve , antiretroviral (ARV)-experienced patients with CD4 counts > 50 cells/mm3 enrolled in this prospect i ve , 12-week , multisite , open-label study . Patients self-administered enfuvirtide , 90 mg bid , using thin-walled , 31-gauge/8-mm needles in combination with other ARVs . QoL was evaluated with MOS-HIV . Results : Of the 361 patients enrolled , 346 contributed to QoL assessment s. Baseline median HIV RNA and CD4 counts were 4.21 log10 copies/mL and 203 cells/mm3 , respectively . Although no baseline factors were predictive of week 12 QoL improvement , 9 of 11 MOS-HIV domain scores improved significantly , including physical function ( p = .0002 ) and mental health ( p = .0006 ) . Through week 12 , 87 % of patients reported ISRs ; 59 % and 28 % reported worst pain/discomfort grade ≤1 and grade ≥2 , respectively , and none were considered serious . Patients reported that self-injection minimally impacted daily functioning or activities . Conclusion : Although no predictors of QoL were identified , significant improvements in QoL were observed with minimal clinical ly significant ISRs ( grade ≥2 ) using the 31-gauge/8-mm needle Background Lipodystrophy , dyslipidaemia and insulin resistance often complicate protease inhibitor-containing antiretroviral therapy . The aims of this study were to determine if these are reversible with continued HIV suppression following protease inhibitor substitution . Methods Eighty-one HIV protease inhibitor recipients ( 78 male ; mean antiretroviral therapy , 55 months ) with predominant peripheral lipoatrophy , HIV RNA < 400 copies/ml plasma for at least the preceding 6 months , and no prior abacavir , non-nucleoside analogue or adefovir therapy were r and omized 3 : 2 to continue nucleoside analogues and substitute protease inhibitor(s ) with abacavir , nevirapine , adefovir and hydroxyurea ( n = 49 ) or to continue all therapy ( n = 32 ) with an option to switch at week 24 . The primary endpoints were total body fat and HIV RNA at week 24 . Other assessment s were regimen safety , regional body composition , metabolic parameters , quality of life , and CD4 T-lymphocyte counts to week 48 . Results There was a greater decline in total body fat in the switch group than in the continue group ( −1.6 and −0.4 kg , respectively at week 24;P = 0.006 ) . This comprised greater declines in limb and subcutaneous abdominal fat , and in intra-abdominal fat of patients with moderate or severe abdominal fat accumulation . Viral suppression was similar , despite 18 ( 37 % ) switch group patients ceasing at least one study drug by week 24 because of adverse events . Total cholesterol and triglycerides declined more in the switch group ( both P < 0.002 ) . High density lipoprotein cholesterol increased significantly in both groups at week 48 ( P < 0.02 ) . There was no change for any glycaemic parameter . Conclusions In predominantly lipoatrophic patients , switching from HIV protease inhibitor therapy lead to improved lipids and less intra-abdominal fat , but also to less peripheral fat , and had minimal effect on insulin resistance . Virological control in these heavily pretreated patients was unaffected , despite frequent switch drug cessations The health-related quality of life ( HRQoL ) outcomes in HIV-infected , treatment-naive patients starting different HAART regimens in a 3-year , r and omized , multinational trial were compared . HRQoL was measured in a subgroup of patients enrolled in the INITIO study ( 153/911 ) , using a modified version of the MOS-HIV question naire . The regimens compared in the INITIO trial were composed by two NRTIs ( didanosine + stavudine ) plus either an NNRTI ( efavirenz ) or a PI ( nelfinavir ) , or both ( efavirenz + nelfinavir ) . Primary HRQoL outcomes were Physical and Mental Health Summary scores ( PHS and MHS , respectively ) . During follow-up , an increase of PHS score was observed in all treatment arms . The MHS score remained substantially unchanged with the four-drug combination and showed with both NNRTI- and PI-based three-drug regimens a marked trend toward improvement , which became statistically significant when a multiple imputation method was used to adjust for missing data . Overall , starting all the combination regimens compared in the INITIO study was associated with a maintained or slightly improved HRQOL status , consistently with the positive immunological and virological changes observed in the main study . The observed differences in the MHS indicate a possible HRQoL benefit associated to the use of three-drug , two-class regimens and no additional benefit for the use of four-drug , three-class regimens , confirming that three-drug , two-class regimens that include two NRTIs plus either an NNRTI or a PI should be preferred as initial treatment of HIV infection |
1,334 | 21,672,626 | Three protocol s were identified , including the arginine-citrulline , the arginine-nitrate , and the oxygen-nitrate protocol s. The arginine-citrulline protocol showed a wider variability compared to the arginine-nitrate and oxygen-nitrate protocol s. The direction of the association between disease state and rate of NO production was essentially determined by the etiopathogenesis of the disorder ( inflammatory , metabolic , vascular ) .
The precision of several aspects of the techniques and the validity of some assumptions made remain unknown , and there is a paucity of information about physiological rates of NO production from childhood over adolescence to old age | Stable isotopic methods are considered the " gold st and ard " for the measurement of rates of in vivo NO production .
However , values reported for healthy human individuals differ by more than 1 order of magnitude .
The reason for the apparent variability in NO production is unclear .
The primary aim of this review was to evaluate and compare the rates of in vivo NO production in health and disease using stable isotope methods . | There is indirect evidence for a gender difference in nitric oxide ( NO ) synthesis from vascular endothelium . The aim of the present study was to determine NO production more directly in healthy women and men by the measurement of 15N nitrate excreted in urine after the intravenous administration of L-[15N]2-guanidino arginine . Twenty-four healthy volunteers ( 13 men aged 22 to 40 years and 11 women aged 23 to 42 years ) participated in this study . No subjects were receiving any medication . Women were studied between the 7th and 14th days of their menstrual cycles . Arterial blood pressure was measured oscillometrically , and 1.13 micromol L-[15N]2 arginine was administered intravenously after an overnight fast . Urine was collected for the next 36 hours in separate 12-hour periods . Urinary 15N/14N nitrate ratio was assessed by dry combustion in an isotope ratio mass spectrometer . Mean 36-hour urinary 15N nitrate excretion was greater in women than in men ( 2111+/-139 versus 1682+/-87 etamol ; P<0.05 ) . Furthermore , total urinary 15N nitrate excretion was associated inversely with the mean arterial blood pressure in the whole group of subjects ( coefficient of correlation , 0.47 ; P=0.022 ) . The present data show that whole-body production of NO is greater in healthy premenopausal women than in men under ambulatory conditions . The cellular origin of NO measured in this study is unknown , but differences in endothelial production could underlie differences in vascular function between men and women & NA ; Current methods for assessing vasomotor endothelial function are impractical for use in large studies . We tested the hypothesis that pulse‐wave analysis ( PWA ) combined with provocative pharmacological testing might provide an alternative method . Radial artery waveforms were recorded and augmentation index ( AIx ) was calculated from derived aortic waveforms . Thirteen subjects received sublingual nitroglycerin ( NTG ) , inhaled albuterol , or placebo . Twelve subjects received NTG , albuterol , and placebo separately during an infusion of NG‐monomethyl‐L‐arginine ( LNMMA ) or norepinephrine . Twenty‐seven hypercholesterolemic subjects and 27 controls received NTG followed by albuterol . Endothelial function was assessed by PWA and forearm blood flow in 27 subjects . Albuterol and NTG both significantly and repeatably reduced AIx ( P<0.001 ) . Only the response to albuterol was inhibited by LNMMA ( −9.8±5.5 % vs −4.7±2.7 % ; P=0.02 ) . Baseline AIx was higher in the hypercholesterolemic subjects , who exhibited a reduced response to albuterol ( P=0.02 ) but not to NTG when compared with matched controls . The responses to albuterol and acetylcholine were correlated ( r=0.5 , P= 0.02 ) . Consistent with an endothelium‐dependent effect , the response to albuterol was substantially inhibited by LNMMA . Importantly , the response to albuterol was reduced in subjects with hypercholesterolemia and was correlated to that of intra‐arterial acetylcholine . This methodology provides a simple , repeatable , noninvasive means of assessing endothelial function in vivo We investigated the effects of a high dietary supplement of arginine on plasma arginine , ornithine , and leucine kinetics and on urea production and excretion in five healthy young adult men . Subjects received either 56 or 561 mg arginine.kg-1.day-1 for 6 days via a complete L-amino acid diet , and on day 7 a tracer protocol ( first 3 h fasted ; next 5 h fed ) was conducted , involving primed constant intragastric infusions of L-[15N2-guanidino,5,5 - 2H2]arginine , L-[5 - 13C]ornithine , L-[5,5,5 - 2H3]leucine , and [15N2]urea , with a prime of H13CO3 . Plasma arginine and ornithine fluxes increased significantly ( P < 0.05 ) with arginine supplementation , as did the rate of conversion of plasma labeled arginine to ornithine ( P < 0.05 ) and rate of ornithine oxidation ( P < 0.001 ) . However , absolute changes in ornithine kinetics were less than those for arginine or those based on changes expected from the change in arginine intake , implying a complex compartmentation in both whole body arginine and ornithine metabolism . The plasma NO3 concentration , daily output of total NO3 , and conversion of [15N]arginine to NO3 did not differ between the diets . Urea production and excretion were reduced significantly with arginine supplementation , suggesting an anabolic effect on the whole body nitrogen economy , possibly via the raised plasma insulin levels ( P = 0.013 ) during the pr and ial phase OBJECTIVE A reduced bioactivity of endothelial nitric oxide ( NO ) has been implicated in the pathogenesis of atherosclerosis . In humans , the endothelial L-arginine-NO pathway has been indirectly assessed via the flow response to endothelium-dependent vasodilators locally administered into the coronary , pulmonary or forearm circulation . However , biochemical quantification of endothelial NO formation in these organ circulations has been hampered so far because of the rapid metabolism of NO . Therefore , we aim ed to work out a reliable biochemical index to assess endothelial NO formation in human circulation . METHODS In 33 healthy volunteers , forearm blood flow ( FBF ) was measured by st and ard techniques of venous occlusion plethysmography at rest , after local application of the endothelium-dependent vasodilator acetylcholine ( ACH ) , the endothelium-independent vasodilator papaverine ( PAP ) , the stereospecific inhibitor of endothelial NO synthase ( eNOS ) L-NMMA , and L-arginine ( ARG ) , the natural substrate of eNOS . In parallel , nitrite and nitrate concentrations in blood sample s taken from the antecubital vein were measured by HPLC using anion-exchange chromatography in combination with electrochemical and ultraviolet detection following a specific sample preparation method . RESULTS ACH dose-dependently increased resting FBF ( from 3.0 + /- 0.3 to 10.4 + /- 0.9 ml/min per 100 ml tissue ) and serum nitrite concentration ( from 402 + /- 59 to 977 + /- 82 nmol/l , both p < 0.05 , n = 12 ) . A significant correlation was observed between the changes in FBF and the serum nitrite concentration ( r = 0.61 , p < 0.0001 ) . L-NMMA reduced resting FBF and endothelium-dependent vasodilation by 30 % and this was paralleled by a significant reduction in serum nitrite concentration at the highest dose of ACH ( n = 9 , p < 0.001 ) . PAP increased FBF more than fourfold , but did not affect serum nitrite concentration ( n = 11 ) , whereas ARG significantly increased both FBF and nitrite . Basal serum nitrate amounted to 25 + /- 4 mumol/l and remained constant during the application of ACH , PAP and L-NMMA . CONCLUSIONS The concentration of serum nitrite sensitively reflects changes in endothelial NO formation in human forearm circulation . This biochemical measure may help to characterize the L-arginine-NO pathway in disease states associated with endothelial dysfunction and to further eluci date its pathophysiological significance for the development of atherosclerosis in humans In humans , the role of nitric oxide ( NO ) in host defence is controversial . We prospect ively studied plasma levels of nitrate , the stable end-product of NO formation , during acute infection in 43 patients controlled with regard to dietary nitrate/nitrite . During acute gastroenteritis the mean plasma nitrate level was significantly increased compared with at recovery 4 - 5 weeks later ( 118 vs. 32.5 micromol/l ; p < 0.001 ) , in contrast with the findings in patients with acute pneumonia ( PN ; 34.6 vs. 42.8 micromol/l ) or febrile urinary tract infection ( UTI ; 27.7 vs. 31.3 micromol/l ) . In a second group of 20 retrospectively studied patients with severe PN or UTI , of whom 70 % were bacteraemic , no significantly increased nitrate levels could be demonstrated during the acute stage of infection . These findings indicate that increased NO production , as measured by plasma nitrate , is not a general finding in patients with acute infectious diseases , but may rather be associated with certain pathogens or sites of infection |
1,335 | 26,351,077 | The promising newer approaches may provide reliable means of early and more specific diagnosis and help identify therapeutic interventions for LOAD | Alzheimer ’s disease ( AD ) is a progressive neurodegenerative disorder characterized by loss of memory and other cognitive functions .
AD can be classified into familial AD ( FAD ) and sporadic AD ( SAD ) based on heritability and into early onset AD ( EOAD ) and late onset AD ( LOAD ) based on age of onset .
LOAD cases are more prevalent with genetically complex architecture .
In spite of significant research focused on underst and ing the etiological mechanisms , search for diagnostic biomarker(s ) and disease-modifying therapy is still on .
In this article , we aim to comprehensively review AD literature on established etiological mechanisms including role of beta-amyloid and apolipoprotein E ( APOE ) along with promising newer etiological factors such as epigenetic modifications that have been associated with AD suggesting its multifactorial nature . | Significance MicroRNAs ( miRNAs ) are small ∼22-nt RNAs that are important regulators of posttranscriptional gene expression . Since their initial discovery , they have been shown to be involved in many cellular processes , and their misexpression is associated with disease etiology . Currently , nearly 2,800 human miRNAs are annotated in public repositories . A key question in miRNA research is how many miRNAs are harbored by the human genome . To answer this question , we examined 1,323 short RNA sequence sample s and identified 3,707 novel miRNAs , many of which are human-specific and tissue-specific . Our findings suggest that the human genome expresses a greater number of miRNAs than has previously been appreciated and that many more miRNA molecules may play key roles in disease etiology . Two decades after the discovery of the first animal microRNA ( miRNA ) , the number of miRNAs in animal genomes remains a vexing question . Here , we report findings from analyzing 1,323 short RNA sequencing sample s ( RNA-seq ) from 13 different human tissue types . Using stringent thresholding criteria , we identified 3,707 statistically significant novel mature miRNAs at a false discovery rate of ≤0.05 arising from 3,494 novel precursors ; 91.5 % of these novel miRNAs were identified independently in 10 or more of the processed sample s. Analysis of these novel miRNAs revealed tissue-specific dependencies and a commensurate low Jaccard similarity index in intertissue comparisons . Of these novel miRNAs , 1,657 ( 45 % ) were identified in 43 data sets that were generated by cross-linking followed by Argonaute immunoprecipitation and sequencing ( Ago CLIP-seq ) and represented 3 of the 13 tissues , indicating that these miRNAs are active in the RNA interference pathway . Moreover , experimental investigation through stem-loop PCR of a r and om collection of newly discovered miRNAs in 12 cell lines representing 5 tissues confirmed their presence and tissue dependence . Among the newly identified miRNAs are many novel miRNA clusters , new members of known miRNA clusters , previously unreported products from uncharacterized arms of miRNA precursors , and previously unrecognized paralogues of functionally important miRNA families ( e.g. , miR-15/107 ) . Examination of the sequence conservation across vertebrate and invertebrate organisms showed 56.7 % of the newly discovered miRNAs to be human-specific whereas the majority ( 94.4 % ) are primate lineage-specific . Our findings suggest that the repertoire of human miRNAs is far more extensive than currently represented by public repositories and that there is a significant number of lineage- and /or tissue-specific miRNAs that are uncharacterized Neurofibrillary tangles ( NFT ) constitute one of the cardinal histopathological features of Alzheimer 's disease ( AD ) . To explore in vivo molecular processes involved in the development of NFTs , we compared gene expression profiles of NFT-bearing entorhinal cortex neurons from 19 AD patients , adjacent non-NFT-bearing entorhinal cortex neurons from the same patients , and non-NFT-bearing entorhinal cortex neurons from 14 non-demented , histopathologically normal controls ( ND ) . Of the differentially expressed genes , 225 showed progressively increased expression ( AD NFT neurons > AD non-NFT neurons > ND non-NFT neurons ) or progressively decreased expression ( AD NFT neurons < AD non-NFT neurons < ND non-NFT neurons ) , raising the possibility that they may be related to the early stages of NFT formation . Immunohistochemical studies confirmed that many of the implicated proteins are dysregulated and preferentially localized to NFTs , including apolipoprotein J , interleukin-1 receptor-associated kinase 1 , tissue inhibitor of metalloproteinase 3 , and casein kinase 2 , beta . Functional validation studies are underway to determine which c and i date genes may be causally related to NFT neuropathology , thus providing therapeutic targets for the treatment of AD Since 1992 , the amyloid cascade hypothesis has played the prominent role in explaining the etiology and pathogenesis of Alzheimer 's disease ( AD ) . It proposes that the deposition of β-amyloid ( Aβ ) is the initial pathological event in AD leading to the formation of senile plaques ( SPs ) and then to neurofibrillary tangles ( NFTs ) , neuronal cell death , and ultimately dementia . While there is substantial evidence supporting the hypothesis , there are also limitations : ( 1 ) SP and NFT may develop independently , and ( 2 ) SPs and NFTs may be the products rather than the causes of neurodegeneration in AD . In addition , r and omized clinical trials that tested drugs or antibodies targeting components of the amyloid pathway have been inconclusive . This paper provides a critical overview of the evidence for and against the amyloid cascade hypothesis in AD and provides suggestions for future directions There has been a plausible link between human exposure to aluminum and Alzheimer 's disease for several decades . We contend that the only direct and ethically acceptable experimental test of the ' aluminum hypothesis ' , which would provide unequivocal data specific to the link , is to test the null hypothesis that a reduction in the body burden of aluminum to its lowest practical limit would have no influence upon the incidence , progression , or severity of Alzheimer 's disease . Herein we are testing the hypothesis that silicon-rich mineral waters can be used as non-invasive methods to reduce the body burden of aluminum in individuals with Alzheimer 's disease and a control group consisting of their carers and partners . We have shown that drinking up to 1 L of a silicon-rich mineral water each day for 12 weeks facilitated the removal of aluminum via the urine in both patient and control groups without any concomitant affect upon the urinary excretion of the essential metals , iron and copper . We have provided preliminary evidence that over 12 weeks of silicon-rich mineral water therapy the body burden of aluminum fell in individuals with Alzheimer 's disease and , concomitantly , cognitive performance showed clinical ly relevant improvements in at least 3 out of 15 individuals . This is a first step in a much needed rigorous test of the ' aluminum hypothesis of Alzheimer 's disease ' and a longer term study involving many more individuals is now warranted The formation of 5-hydroxymethylcytosine ( 5hmC ) , a key intermediate of DNA demethylation , is driven by the ten eleven translocation ( TET ) family of proteins that oxidize 5-methylcytosine ( 5mC ) to 5hmC. To determine whether methylation/demethylation status is altered during the progression of Alzheimer 's disease ( AD ) , levels of TET1 , 5mC and subsequent intermediates , including 5hmC , 5-formylcytosine ( 5fC ) and 5-carboxylcytosine ( 5caC ) were quantified in nuclear DNA from the hippocampus/parahippocampal gyrus ( HPG ) and the cerebellum of 5 age-matched normal controls , 5 subjects with pre clinical AD ( PCAD ) and 7 late-stage AD ( LAD ) subjects by immunochemistry . The results showed significantly ( p < 0.05 ) increased levels of TET1 , 5mC , and 5hmC in the HPG of PCAD and LAD subjects . In contrast , levels of 5fC and 5caC were significantly ( p < 0.05 ) decreased in the HPG of PCAD and LAD subjects . Overall , the data suggest altered methylation/demethylation patterns in vulnerable brain regions prior to the onset of clinical symptoms in AD suggesting a role in the pathogenesis of the disease BACKGROUND Memory declines more rapidly with age in apolipoprotein E ( APOE ) epsilon4 carriers than in APOE epsilon4 noncarriers , and APOE epsilon4 homozygotes ' cognitive performances correlate with stressors . These changes could represent presymptomatic disease in some , despite their youth . OBJECTIVE To show that presymptomatic APOE epsilon4 homozygotes experience greater psychometric decline at a younger age than APOE epsilon4 heterozygotes and noncarriers before the diagnosis of mild cognitive impairment ( MCI ) and Alzheimer disease ( AD ) . DESIGN Prospect i ve observational study SETTING Academic medical center . PARTICIPANTS A total of 43 APOE epsilon4 homozygotes , 59 APOE epsilon4 heterozygotes , and 112 APOE epsilon4 noncarriers aged 50 to 69 years were cognitively healthy and matched at entry according to age , educational level , and sex . INTERVENTION Neuropsychological battery given every 2 years . MAIN OUTCOME MEASURES Predefined test and cognitive domain decline criteria applied to consecutive epochs . RESULTS Of 214 participants , 48 showed no decline on any test , 126 showed decline on only 1 test in 1 or more domains , and 40 showed decline on 2 or more tests in 1 or more domains . Cognitive domain decline occurred in 4 of 10 APOE epsilon4 homozygotes 60 years and older at entry ( 40.0 % ) compared with 5 of 66 APOE epsilon4 heterozygotes and noncarriers ( 7.6 % ) ( P = .02 ) and was more predictive of subsequent decline than nondomain decline ( 17 of 24 [ 70.8 % ] vs 29 of 70 [ 41.4 % ] ; P = .01 ) . Decline on any memory test was predictive of further decline ( P < .001 ) , as was memory domain decline ( P = .006 ) in all genetic subgroups . Seven participants developed MCI ( in 6 ) or AD ( in 1 ) , of whom 5 were APOE epsilon4 homozygotes ( P = .008 ) . Retrospective comparison showed that those who experienced multidomain , memory , and language domain decline had lower spatial and memory scores at entry than those who experienced no decline . CONCLUSIONS APOE epsilon4 homozygotes in their 60s have higher rates of cognitive domain decline than APOE epsilon4 heterozygotes or noncarriers before the diagnosis of MCI and AD , thus confirming and characterizing the existence of a pre-MCI state in this genetic subset We present here both linear regressions and multivariate analyses correlating three global neuropsychological tests with a number of structural and neurochemical measurements performed on a prospect i ve series of 15 patients with Alzheimer 's disease and 9 neuropathologically normal subjects . The statistical data show only weak correlations between psychometric indices and plaques and tangles , but the density of neocortical synapses measured by a new immunocytochemical/densitometric technique reveals very powerful correlations with all three psychological assays . Multivariate analysis by stepwise regression produced a model including midfrontal and inferior parietal synapse density , plus inferior parietal plaque counts with a correlation coefficient of 0.96 for Mattis 's Dementia Rating Scale . Plaque density contributed only 26 % of that strength Positional cloning studies to identify disease genes are being carried out for many human genetic diseases . Such studies often include a genome-scan linkage analysis to identify the rough chromosomal location of a disease gene , fine structure genetic mapping to define and narrow the chromosomal interval in which the disease gene may be located , and physical mapping and gene identification in the genetically defined interval to clone the disease gene . During the planning of a positional cloning study , it is important to know that , if linkage is found , the genetic interval identified is likely to be sufficiently narrow to be dissected efficiently by methods of physical mapping and gene identification . Thus , we wish to know the limits of resolution of a genetic linkage study . In this paper , I determine for Mendelian diseases the distributions and moments of three measures of linkage resolution : ( 1 ) in a set of N chromosomes , the distance between the nearest crossovers that flank a disease locus , ( 2 ) the distance between the nearest genetic markers that flank the pair of flanking crossovers after a genome scan , and ( 3 ) the distance between the nearest flanking markers after additional r and omly placed markers are generated and typed in an identified interval . These results provide explicit sample -size guidelines for future positional cloning studies of Mendelian diseases and make possible a more objective evaluation of whether a proposed positional cloning study is likely to be successful . I also briefly discuss the more difficult problem of linkage resolution for complex genetic diseases BACKGROUND Imaging with amyloid-β PET can potentially aid the early and accurate diagnosis of Alzheimer 's disease . Florbetaben ( ¹⁸F ) is a promising ¹⁸F-labelled amyloid-β-targeted PET tracer in clinical development . We aim ed to assess the sensitivity and specificity of florbetaben ( ¹⁸F ) PET in discriminating between patients with probable Alzheimer 's disease and elderly healthy controls . METHODS We did a multicentre , open-label , non-r and omised phase 2 study in 18 centres in Australia , Germany , Switzerl and , and the USA . Imaging with florbetaben ( ¹⁸F ) PET was done on patients with probable Alzheimer 's disease ( age 55 years or older , mini-mental state examination [ MMSE ] score=18 - 26 , clinical dementia rating [CDR]=0·5 - 2·0 ) and age-matched healthy controls ( MMSE ≥ 28 , CDR=0 ) . Our primary objective was to establish the diagnostic efficacy of the scans in differentiating between patients with probable disease and age-matched healthy controls on the basis of neocortical tracer uptake pattern 90 - 110 min post-injection . PET images were assessed visually by three readers masked to the clinical diagnosis and all other clinical findings , and quantitatively by use of pre-established brain volumes of interest to obtain st and ard uptake value ratios ( SUVRs ) , taking the cerebellar cortex as the reference region . This study is registered with Clinical Trials.gov , number NCT00750282 . FINDINGS 81 participants with probable Alzheimer 's disease and 69 healthy controls were assessed . Independent visual assessment of the PET scans showed a sensitivity of 80 % ( 95 % CI 71 - 89 ) and a specificity of 91 % ( 84 - 98 ) for discriminating participants with Alzheimer 's disease from healthy controls . The SUVRs in all neocortical grey-matter regions in participants with Alzheimer 's disease were significantly higher ( p < 0·0001 ) compared with the healthy controls , with the posterior cingulate being the best discriminator . Linear discriminant analysis of regional SUVRs yielded a sensitivity of 85 % and a specificity of 91 % . Regional SUVRs also correlated well with scores of cognitive impairment such as the MMSE and the word-list memory and word-list recall scores ( r -0·27 to -0·33 , p ≤ 0·021 ) . APOE ɛ4 was more common in participants with positive PET images compared with those with negative scans ( 65%vs 22 % [ p=0·027 ] in patients with Alzheimer 's disease ; 50%vs 16 % [ p = 0·074 ] in healthy controls ) . No safety concerns were noted . INTERPRETATION We provide verification of the efficacy , safety , and biological relevance of florbetaben ( ¹⁸F ) amyloid-β PET and suggest its potential as a visual adjunct in the diagnostic algorithm of dementia . FUNDING Bayer Schering Pharma AG |
1,336 | 10,456,590 | Interventions among convicted drunk drivers reduced motor vehicle crashes and injuries .
The results suggest that treatment for problem drinking may reduce injuries and their antecedents . | null | null |
1,337 | 21,543,968 | Esophageal acid exposure time and the prevalence of heartburn are higher after LAF compared with LPF .
In the short-term this is counterbalanced by less severe dysphagia .
However , dysphagia scores become similar in the long-term , with a persistent substantial increase in prevalence of heartburn and PPI use after LAF .
The reoperation rate is twice as high after LAF as well , mainly due to re interventions for recurrent GERD . | OBJECTIVE To compare short- and long-term outcome after laparoscopic anterior fundoplication ( LAF ) versus posterior fundoplication ( LPF ) through a systematic review and meta- analysis of r and omized clinical trials ( RCTs ) .
SUMMARY OF BACKGROUND DATA LPF is currently considered the surgical therapy of choice for gastroesophageal reflux disease ( GERD ) .
Alternatively , LAF has been alleged to reduce troublesome dysphagia and gas-related symptoms . | HYPOTHESIS Laparoscopic anterior 90 degrees partial fundoplication for gastroesophageal reflux is associated with a lower incidence of postoperative dysphagia and other adverse effects compared with laparoscopic Nissen fundoplication . DESIGN A multicenter , prospect i ve , double-blind , r and omized controlled trial . SETTING Nine university teaching hospitals in 6 major cities in Australia and New Zeal and . PARTICIPANTS One hundred twelve patients with proven gastroesophageal reflux disease presenting for laparoscopic fundoplication were r and omized to undergo either a Nissen ( 52 patients ) or an anterior 90 degrees partial procedure ( 60 patients ) . Patients with esophageal motility disorders , patients requiring a concurrent abdominal procedure , and patients who had undergone previous antireflux surgery were excluded from this study . INTERVENTIONS Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication . MAIN OUTCOME MEASURES Independent assessment of dysphagia , heartburn , and overall satisfaction 1 , 3 , and 6 months after surgery using multiple clinical grading systems . Objective measurement of esophageal manometric parameters , esophageal acid exposure , and endoscopic assessment . RESULTS Postoperative dysphagia , and wind-related adverse effects were less common after a laparoscopic anterior 90 degrees partial fundoplication . Relief of heartburn was better following laparoscopic Nissen fundoplication . Overall satisfaction was better after anterior 90 degrees partial fundoplication . Lower esophageal sphincter pressure , acid exposure , and endoscopy findings were similar for both procedures . CONCLUSIONS At the 6-month follow-up , laparoscopic anterior 90 degrees culine partial fundoplication is followed by fewer adverse effects than laparoscopic Nissen fundoplication with full fundal mobilization , and it achieves a higher rate of satisfaction with the overall outcome . However , this is offset to some extent by a greater likelihood of recurrent gastroesophageal reflux symptoms BACKGROUND Total fundoplication for gastro-oesophageal reflux disease may be followed by unwanted side-effects . A r and omized trial demonstrated that an anterior 180 degrees partial fundoplication achieved effective reflux control and was associated with fewer side-effects in the short term than total fundoplication . This paper reports longer-term ( 5 year ) outcomes from that trial . METHODS Between December 1995 and June 1997 , 107 patients were r and omized to undergo either laparoscopic total fundoplication or a laparoscopic anterior 180 degrees fundoplication . After 5 years , 101 of 103 eligible patients ( 51 total , 50 anterior ) were available for follow-up . Each patient was interviewed by a single blinded investigator and a st and ardized question naire was completed . The question naire focused on symptoms and overall satisfaction with the results of fundoplication . RESULTS There were no significant differences between the two groups with regard to control of heartburn or patient satisfaction with the overall outcome . Dysphagia , measured by a visual analogue score for solid food and a composite dysphagia score , was worse at 5 years after total fundoplication . Symptoms of bloating , inability to belch and flatulence were also more common after total fundoplication . Reoperation was required for dysphagia in three patients after total fundoplication and for recurrent reflux in three patients after anterior fundoplication . CONCLUSION Anterior 180 degrees partial fundoplication was as effective as total fundoplication for managing the symptoms of gastro-oesophageal reflux in the longer term . It was associated with a lower incidence of side-effects , although this was offset by a slightly higher risk of recurrent reflux symptoms In Barrett ’s esophagus , total abolition of reflux may give maximum protection against the development of malignancy . To determine whether laparoscopic anterior fundoplication gives the same degree of antireflux control as a total fundoplication , we analyzed a prospect ively followed cohort of patients from r and omized controlled trials of laparoscopic antireflux surgery . There were 167 patients who returned for routine esophageal pH studies within 6 months of surgery ( 123 laparoscopic total fundoplications and 44 anterior fundoplications ) . There was no difference in percentage time pH < 4 between fundoplication groups , but the total number of reflux episodes was significantly different ( total fundoplication , four reflux events vs. partial fundoplication , six reflux events ; p = 0.03 ) . It is difficult to believe that this difference is either biologically or clinical ly important . In patients with a second esophageal pH study more than 5 years later , both the percentage time pH < 4 ( 0.1 % total fundoplication vs. 2.7 % partial fundoplication ; p = 0.004 ) and total number of reflux episodes ( three total fundoplication vs. 24 partial fundoplication ; p = 0.002 ) were significantly different . However , the postoperative esophageal acid exposure was within the normal range for both total and partial fundoplication , so whether the statistical difference is clinical ly important , remains a moot point Objective : To compare 10 years outcome of a multicenter r and omized controlled trial on laparoscopic ( LNF ) and conventional Nissen fundoplication ( CNF ) , with focus on effectiveness and reoperation rate . Summary of Background Data : LNF has replaced CNF as surgical treatment for gastroesophageal reflux disease ( GERD ) . Decisions are based on equal short-term effectiveness and reduced morbidity , but confirmation by long-term level 1 evidence is lacking . Methods : From 1997 to 1999 , 177 proton pump inhibitor (PPI)-refractory GERD patients were r and omized to undergo LNF or CNF . The 10 years results of surgery on reflux symptoms , general health , PPI use , and reoperation rates , are described . High-resolution manometry , 24-hour pH-impedance monitoring and barium swallow were performed in symptomatic patients only . Results : A total of 148 patients ( 79 LNF , 69 CNF ) participated in this 10-year follow-up study . GERD symptoms were relieved in 92.4 % and 90.7 % ( NS ) after LNF and CNF , respectively . Severity of heartburn and dysphagia were similar , but slightly more patients had relief of regurgitation after LNF ( 98.7 % vs. 91.0 % ; P = 0.030 ) . The percentage of patients using PPIs slowly increased with time in both groups to 26.6 % for LNF and 22.4 % for CNF ( NS ) . General health ( 74.7 % vs. 72.7 % ; NS ) and quality of life ( visual analogue scale score : 65.3 vs. 61.4 ; NS ) improved similarly in both groups . The percentage of patients who would have opted for surgery again was similar as well ( 78.5 % vs. 72.7 % ; NS ) . Twice as many patients underwent reoperation after CNF compared with LNF ( 12 [ 15.2 % ] vs. 24 [ 34.8 % ] ; P = 0.006 ) , including a higher number of incisional hernia corrections ( 2 vs. 9 ; P = 0.015 ) . Mean interval between operation and reintervention was longer after CNF ( 22.9 vs. 50.6 months ; P = 0.047 ) . Of the patients who were dependent on daily PPI therapy at 10 years ( LNF 10 , CNF 10 ) , 7 patients ( LNF 3 , CNF 4 ) had recurrent GERD on pH-impedance monitoring , 5 of them with some form of anatomic recurrence . A total of 13 of 20 ( 65.0 % ) patients did not have recurrent GERD . Fourteen patients had an abnormal high-resolution manometry . Conclusions : CNF carries a higher risk for surgical reintervention compared with LNF , mainly due to incisional hernia corrections . The 10-year effectiveness of LNF and CNF is comparable in terms of improvement of GERD symptoms , PPI use , quality of life , and objective reflux control . Consequently , the long-term results from this trial lend level 1 support to the use of LNF as the surgical procedure of choice for GERD BACKGROUND The effect of total ( Nissen ) and anterior partial fundoplication ( APF ) for the surgical treatment of gastroesophageal reflux disease ( GERD ) on the motor behavior of the esophagogastric axis has not been fully assessed . The purpose of this study was to assess any alterations in lower esophageal sphincter ( LES ) and gastric fundus motor parameters in GERD patients after Nissen or APF fundoplication . METHODS Twenty four patients with documented GERD underwent either laparoscopic Nissen fundoplication ( n = 12 ) or laparoscopic APF ( n = 12 ) . Preoperative and postoperative stationary esophageal manometry included assessment of LES resting and postdeglutition relaxation pressures , intragastric pressure , and LES transient relaxations in the left lateral and upright positions and after gastric distension . RESULTS Both types of fundoplication result ed in significant increases in LES resting ( P < 0.001 ) and postdeglutition relaxation pressure ( P < 0.001 ) in both positions and after gastric distention . Intragastric pressure increased only after Nissen fundoplication in the postgastric distention state ( P = 0.01 ) . Transient LES relaxations were equally abolished after both procedures . All postoperative changes were to a similar level after either procedure with the exception of intragastric pressure after gastric distention , which was significantly higher after total than after partial fundoplication ( P = 0.04 ) . CONCLUSIONS Both procedures equally increase LES resting and postdeglutition relaxation pressures and abolish transient LES relaxations at all states . The significantly higher intragastric pressure at the postgastric distention state after Nissen fundoplication could possibly explain the higher incidence of epigastric fullness and discomfort after this type of antireflux surgery In the operative management of gastro‐oesophageal reflux , a balance must be achieved between adequate control of reflux and excessive dysphagia . The ideal technique is not known . A r and omized study was performed to determine whether laparoscopic anterior fundoplication is associated with a lower incidence of postoperative dysphagia than laparoscopic Nissen fundoplication , while achieving equivalent control of reflux How best to surgically treat GERD is an unresolved issue . To increase our insights into the fundoplication procedures , functional consequences for the gastroesophageal junction of an anterior or a posterior partial fundoplication were studied by manometry . Patients were r and omly selected from a larger study in a r and omised comparison between posterior and anterior partial fundoplications . The manometric studies were done 12 months after respective procedures in 24 patients . The motor characteristics of the esophagus and lower esophageal sphincter ( LES ) function were determined by use of sleeve catheter manometry . The manometric characteristics of the esophageal body were similar in the study groups except for the ramp pressure . This was significantly higher in patients with posterior partial fundoplications . The posterior group had significantly longer total length ( P < 0.02 ) as well as longer intra-abdominal portions ( P = 0.07 ) of the LES while the basal tone , albeit numerically higher , did not reach statistical significance . Water-swallow induced LES relaxations reached lower nadir values in the anterior group ( 1.7 vs 2.7 mmHg ) . Gas distension triggered few transient LES relaxations in both study groups while common cavities were more frequently observed in those having an anterior partial wrap ( P < 0.01 ) . A posterior partial fundoplication is followed by manometric characteristics suggesting a well functioning antireflux barrier with some obstruction to bolus passage as well as restricted venting of air from the stomach . The manometric mechanisms behind the inferior reflux control achieved by a Watson type of anterior partial wrap has now been further eluci date BACKGROUND AND AIMS The purpose of this study was to determine whether esophageal dysmotility affects symptoms of gastroesophageal reflux disease or clinical outcome after laparoscopic fundoplication and whether esophagus motor function changes postoperatively . METHODS Two hundred patients with a history of long-st and ing gastroesophageal reflux disease were investigated by clinical assessment , upper gastrointestinal endoscopy , esophageal manometry , and 24-hour pH monitoring between May 1999 and May 2000 . Patients were stratified according to presence or absence of esophageal dysmotility ( each n = 100 ) and r and omized to either 360 degrees ( Nissen ) or 270 degrees ( Toupet ) fundoplication . At a 4-month postoperative follow-up , preoperative tests were repeated . RESULTS Preoperative esophageal dysmotility was associated with more severe reflux symptoms , more frequent resistance to medical treatment ( 64 % vs. 49 % ; P < 0.05 ) , and greater decrease in lower esophageal sphincter pressure ( 9.5 + /- 5.3 vs. 12.4 + /- 6.7 mm Hg ; P < 0.0005 ) compared with normal motility . Postoperatively , clinical outcome and reflux recurrence ( 21 % vs. 14 % ) were similar . Esophageal motility remained unchanged in 85 % of patients and changed from pathologic to normal in 20 ( 10 Nissen/10 Toupet ) and vice versa in 9 ( 8 Nissen/1 Toupet ) patients . CONCLUSIONS Esophageal dysmotility ( 1 ) reflects more severe disease ; ( 2 ) does not affect postoperative clinical outcome ; ( 3 ) is not corrected by fundoplication , independent of the surgical procedure performed ; ( 4 ) may occur as a result of fundoplication ; and ( 5 ) requires no tailoring of surgical management Objective The aim of the study was to compare the efficacy and mechanical consequences of 2 partial fundoplications performed laparoscopically under the framework of a r and omized , controlled clinical trial . Summary Background Data Although laparoscopic total fundoplication procedures have proven their effectiveness in the control of gastroesophageal reflux , problems remain with the functional consequences after a supra-competent gastric cardia high-pressure zone . Partial fundoplications have been found to be associated with fewer mechanical side effects . Patients and Methods During a 2-year period , 95 patients with gastroesophageal reflux disease were enrolled into a r and omized , controlled single-institution clinical trial comparing a partial posterior ( Toupét , n = 48 ) fundoplication and an anterior partial wrap ( Watson , n = 47 ) . All patients were assessed postoperatively at predefined time points , and the 12-month follow-up data are presented in terms of clinical results and 24-hour pH monitoring variables . Results Both patient groups were strictly comparable at the time of r and omization . All operations were completed laparoscopically , and no serious complications were encountered . During the first postoperative year , a difference regarding the control of reflux symptoms was observed in favor of the posterior fundoplication . Esophageal acid exposure ( % time pH < 4 ) was substantially reduced by both operations but to a significantly lower level after a Toupét compared with the Watson partial fundoplication ( 1.0 ± 0.3 vs. 5.6 ± 1.1 mean ± SEM ; p < 0.001 ) . Postfundoplication symptoms were infrequently recorded with no difference between the groups . Conclusions When performing a laparoscopic partial fundoplication , the posterior modification ( Toupét ) offers advantages in terms of better reflux control compared with an anterior type ( Watson ) Recently we have shown that laparoscopic Toupet fundoplication is associated with a high degree of late failure when employed as a primary treatment for gastroesophageal reflux disease ( GERD ) . This study defines preoperative risk factors that predispose patients to failure . Data from 48 patients with objective follow-up performed as part of a prospect i ve long-term outcomes project ( 24-hour pH monitoring , manometry , and esophagogastroduodenoscopy [ EGD ] at 6 months , 3 years , and 6 years ) was analyzed . Preoperative studies of patients with documented postoperative failure ( n = 22 ) , defined as an abnormal 24-hour pH study ( DeMeester score > 14.9 ) , were compared to preoperative studies of patients with normal 24-hour pH studies ( n = 26 ) . Outcomes were assessed at a mean of 22 months ( range 18 to 37 months ) postoperatively . Of the 22 patients in the failure group , 16 ( 77 % ) were symptomatic and the majority ( 64 % ) had resumed proton pump inhibitor therapy . Preoperative indices of severe reflux were significantly more prevalent in the failure group including a very low or absent lower esophageal sphincter ( LES ) pressure on manometry , biopsy-proved Barrett ’s metaplasia , presence of a stricture , grade III or greater esophagitis , and a DeMeester score greater than 50 with ambulatory 24-hour pH testing . Comparison of pre- and postoperative manometric analysis of the LES revealed adequate augmentation of the LES in both groups and there were no wrap disruptions documented by postoperative EGD or manometry , indicating that reflux was most likely occurring through an intact wrap in the failure group . Esophageal dysmotility was present before surgery in four of the nonrefluxing patients and in three of the failures . Intact wraps were noted to have herniated in eight patients , all of whom had postoperative reflux . Laparoscopic Toupet fundoplication is associated with a high rate of failure both clinical ly and by objective testing . Surgery is more likely to fail in patients with severe GERD than in patients with uncomplicated or mild disease . A preoperative DeMeester score greater than 50 was 86 % sensitive for predicting failure in our patient population . Laparoscopic Toupet fundoplication should not be used as a st and ard antireflux procedure particularly in patients with severe or complicated reflux disease This double‐blind , r and omized study compared outcomes of laparoscopic Nissen total fundoplication and anterior partial fundoplication carried out by a single surgeon in a private practice A prospect i ve double-blind r and omized trial wasinitiated to examine two types of laparoscopicfundoplication ( Nissen and anterior ) . Thirty-two patients with proven gastroesophageal reflux diseasepresenting for primary laparoscopic antireflux surgerywere r and omized to undergo either Nissen fundoplication(N = 13 ) or anterior hemifundoplication ( N = 19).Postoperative fluoroscopic and manometric examinationwas carried out concomitantly . Nissenfundoplication result ed in significantly greaterelevation of resting ( 33.5 vs 23 mm Hg ) and residuallower esophageal sphincter pressures ( 17 vs 6.5 mm Hg ) and lower esophageal ramp pressure ( 26 vs 20.5 mm Hg ) than theanterior partial fundoplication . A smallerradiologically measured sphincter opening diameter wasseen following Nissen fundoplication ( 9 mm ) comparedwith anterior fundoplication ( 12 mm ) . Lower esophageal ramppressure correlated weakly ( r = 0.37 , P = 0.04 ) withpostoperative dysphagia . It is concluded that the typeof fundoplication performed significantly influences postoperative manometric and video bariumradiology outcomes . The clinical relevance of thisrequires further investigation Background Reflux recurrence is the most common long-term complication of fundoplication . Its frequency was independent from the type of fundoplication in r and omized studies . Results for different techniques of laparoscopic antireflux surgery were retrospectively evaluated after 10 years . Methods From 1992 to 1997 , 120 patients had primary laparoscopic fundoplication with a “ tailored approach ” ( type of wrap chosen according to esophageal peristalsis ) : 88 received a Nissen , 22 an anterior , and 10 a Toupet fundoplication . Follow-up of 87 % of the patients included disease-related questions and the gastrointestinal quality -of-life index ( GIQLI ) . Results Of the patients , 89 % would select surgery again . Heartburn was reported by 30 % of the patients . Regurgitations were noted from 15 % of patients after a Nissen , 44 % after anterior fundoplication , and 10 % after a Toupet ( p = 0.04 ) . Twenty-eight percent were on acid-suppressive drugs again . Following Nissen fundoplication , proton pump inhibitors were less frequently used ( p = 0.01 ) and on postoperative pH-metry reflux recurrence rate was lower ( p = 0.04 ) . The GIQLI was 110 ± 24 without significant differences for the type of fundoplication . Discussion Ten years after laparoscopic fundoplication , overall outcome is good . A quarter of the patients are on acid-suppressive drugs . Nissen fundoplication appears to control reflux better than a partial fundoplication Objective : The purpose of this prospect i ve study was to compare the subjective and objective outcome of laparoscopic ( LNF ) and conventional Nissen fundoplication ( CNF ) up to 5 years after surgery as obtained in a multicenter r and omized controlled trial . Summary of Background Data : LNF is regarded as surgical treatment of first choice for refractory gastroesophageal reflux disease by many surgeons based on several short- and mid-term studies . The long-term efficacy of Nissen fundoplication , however , is still question ed as objective data gathered from prospect i ve studies are lacking . Methods : From 1997 to 1999 , 177 patients were r and omized to undergo LNF or CNF . Five years after surgery , all patients were requested to fill in question naires and to undergo esophageal manometry and 24-hour pH-metry . Results : A total of 148 patients agreed to participate in the follow-up study : 79 patients after LNF and 69 after CNF . Of these , 97 patients ( 48 LNF , 49 CNF ) consented to undergo esophageal manometry and 24-hour pH-metry . At 5 years follow-up , 20 patients had undergone reoperation : 12 after LNF ( 15 % ) and 8 after CNF ( 12 % ) . There was no difference in subjective outcome , with overall satisfaction rates of 88 % and 90 % , respectively . Total esophageal acid exposure times ( pH < 4 ) were 2.1 % ± 0.5 % and 2.0 % ± 0.6 % , respectively ( P = 0.21 ) . Antisecretory medication was taken daily in 14 % and 16 % , respectively ( P = 0.29 ) . There was no correlation between medication use and acid exposure and indices of symptom-reflux association ( symptom index and symptom association probability ) . No significant differences between subjective and objective results at 3 to 6 months and results obtained at 5 years after surgery were found . Conclusions : The effects of LNF and CNF on general state of health and objective reflux control are sustained up to 5 years after surgery and the long-term results of LNF and CNF are comparable . A substantial minority of patients in both groups had a second antireflux operation or took antisecretory drugs , although the use of those medications did not appear to be related to abnormal esophageal acid exposure BACKGROUND It has been proposed that partial fundoplication is associated with less incidence of postoperative dysphagia and consequently is more suitable for patients with gastroesophageal reflux disease ( GERD ) and impaired esophageal body motility . The aim of this study was to assess whether outcomes of Toupet fundoplication ( TF ) are better than those of Nissen-Rossetti fundoplication ( NF ) in patients with GERD and low-amplitude esophageal peristalsis . STUDY DESIGN Thirty-three consecutive patients with proved GERD and amplitude of peristalsis at 5 cm proximal to lower esophageal sphincter ( LES ) less than 30 mmHg were r and omly allocated to undergo either TF ( 19 patients : 11 men , 8 women ; mean age : 61.7 + /- 8.7 SD years ) or NF ( 14 patients : 7 men , 7 women ; mean age : 59.2 + /- 11.5 years ) , both by the laparoscopic approach . Pre- and postoperative assessment included clinical question naires , esophageal radiology , esophageal transit time study , endoscopy , stationary manometry , and 24-hour ambulatory esophageal pH testing . RESULTS Duration of operation was significantly prolonged in the TF arm ( TF : 90 + /- 12 minutes versus NF : 67 + /- 15 minutes ; p < 0.001 ) . At 3 months postoperatively , the incidences of dysphagia ( grade s I , II , III ) and gas-bloat syndrome were higher after NF than after TF ( NF : 57 % versus TF : 16 % ; p < 0.01 and NF : 50 % versus TF : 21 % ; p = 0.02 , respectively ) , but decreased to the same level in both groups at the 1-year followup ( NF : 14 % versus TF : 16 % and NF : 21 % versus TF : 16 % , respectively ) . At 3 months postoperatively , patients with NF presented with significantly increased LES pressure than those with TF ( p = 0.02 ) , although LES pressure significantly increased after surgery in both groups , as compared with preoperative values . Amplitude of esophageal peristalsis at 5 cm proximal to LES increased postoperatively to the same extent in both groups ( TF , preoperatively : 21 + /- 6 mmHg versus postoperatively : 39 + /- 12 mmHg ; p < 0.001 , and NF , preoperatively : 20 + /- 8 mmHg versus postoperatively : 38 + /- 12 mmHg ; p < 0.001 ) . Reflux was abolished in all patients of both groups . CONCLUSIONS Both TF and NF efficiently control reflux in patients with GERD and low amplitude of esophageal peristalsis . Early in the postoperative period , TF is associated with fewer functional symptoms , although at 1 year after surgery those symptoms are reported at similar frequencies after either procedure HYPOTHESIS Laparoscopic 90 degrees anterior partial fundoplication for gastroesophageal reflux disease achieves equivalent results to laparoscopic Nissen fundoplication . DESIGN A multicenter , prospect i ve , double-blind r and omized clinical trial with a minimum of 5 years ' follow-up . SETTING Nine university teaching hospitals in 6 major cities throughout Australia and New Zeal and . PARTICIPANTS One hundred twelve patients undergoing primary antireflux surgery were r and omized to undergo either laparoscopic Nissen fundoplication ( 52 patients ) or anterior 90 degrees partial fundoplication ( 60 patients ) . INTERVENTIONS Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication . MAIN OUTCOME MEASURES Blinded assessment at 1 and 5 years ' follow-up of clinical outcome for postoperative heartburn , dysphagia , gas-related symptoms , and satisfaction with the surgical outcome . Analog scales ranging from 0 to 10 were used to assess symptom severity . RESULTS Ninety-seven patients underwent follow-up at 5 years . Three others died during follow-up , 4 refused follow-up , and 8 were lost to follow-up ; 89 % remained at 5-years ' follow-up . At 5 years ' follow-up , mean analog scores for heartburn were 2.2 for anterior fundoplication vs 0.9 for Nissen fundoplication ( P=.003 ) . There were no significant differences between the groups for dysphagia scores . The mean score for outcome satisfaction was 7.1 after anterior fundoplication vs 8.1 after Nissen fundoplication ( P=.18 ) . Eighty-eight percent reported a good or excellent outcome following Nissen fundoplication vs 77 % following anterior fundoplication . CONCLUSIONS Laparoscopic Nissen and anterior 90 degrees partial fundoplication achieve similar levels of patient satisfaction at 5 years ' follow-up , with similar adverse effect profiles . However , at 5 years ' follow-up , laparoscopic Nissen fundoplication achieves superior control of reflux symptoms . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Register Identifier : ACTRN12607000298415 To define the clinical role of antireflux surgical procedures a proper underst and ing of their mode of action is required . The aim of this study was to investigate the impact of total or posterior partial fundoplication on the function of the lower oesophageal sphincter ( LOS ) in the basal state as well as during stimulation BACKGROUND The short-term clinical outcomes from a multicenter prospect i ve r and omized trial of laparoscopic Nissen versus anterior 90 degrees partial fundoplication have been reported previously . These demonstrated a high level of satisfaction with the overall outcome following anterior 90 degrees fundoplication . However , the results of postoperative objective tests and specific clinical symptoms are not always consistent with an individual patient 's functional status and general well being following surgery , and quality of life ( QOL ) is also an important outcome to consider following surgery for reflux . Hence , QOL information was collected in this trial to investigate the hypothesis : improvements in QOL following laparoscopic antireflux surgery are greater after anterior 90 degrees partial fundoplication than after Nissen fundoplication . METHODS Patients undergoing a laparoscopic fundoplication for gastro-esophageal reflux at one of nine university teaching hospitals in six major cities in Australia and New Zeal and were r and omized to undergo either laparoscopic Nissen or anterior 90 degrees partial fundoplication . Quality of life before and after surgery was assessed using vali date d question naires - the Short Form 36 general health question naire ( SF36 ) and an Illness Behavior Question naire ( IBQ ) . Patients were asked to complete these question naires preoperatively and at 3 , 6 , 12 and 24 months postoperatively . RESULTS One hundred and twelve patients were r and omized to undergo a Nissen fundoplication ( 52 ) or a 90 degrees anterior fundoplication ( 60 ) . Patients who underwent anterior fundoplication reported significant improvements in eight of the nine SF36 scales compared to four of the nine following a Nissen fundoplication . The majority of these improvements occurred early in the postoperative period . With respect to the illness behavior data , there were no significant differences between the two procedures . Both groups had a significant improvement in disease conviction scores at all time points compared to their preoperative scores . CONCLUSIONS Patients undergoing laparoscopic anterior 90 degrees partial fundoplication reported more QOL improvements in the early postoperative period than patients undergoing a Nissen fundoplication . However , the QOL outcome for both procedures was similar at later follow-up A r and omized trial of laparoscopic Nissen fundoplication and anterior 180 ° partial fundoplication was undertaken to determine whether the anterior procedure might reduce the incidence of dysphagia and other adverse outcomes following surgery for gastro‐oesophageal reflux disease . This study evaluated clinical outcomes after 10 years Objective : The aim of this study was to compare the long-term objective and subjective outcomes of laparoscopic and open Nissen fundoplication in a r and omized clinical trial with an 11-year follow-up . Summary Background Data : Laparoscopic Nissen fundoplication has become the method of choice in antireflux surgery , replacing its open counterpart despite the lack of long-term results from controlled clinical studies . Methods : Between April 1992 and June 1995 , 110 consecutive patients were r and omized to either laparoscopic ( LAP ) or conventional ( open ) Nissen fundoplication . The objective long-term follow-up consisted of an upper gastrointestinal endoscopy and a clinical assessment ; the subjective long-term outcome was investigated by personal interviews using a structured question naire . Results : Forty-nine patients in the LAP group and 37 patients in the open group were available for evaluation . Late subjective results , including postoperative symptoms and evaluation of the surgical result , were similar in both groups . With the benefit of hindsight , 73.7 % of the patients in the open group and 81.8 % in the LAP group would again choose surgical treatment ( P = 0.3042 ) . In the LAP group , there were 5 ( 13.2 % ) partially or totally disrupted plications compared with the 14 ( 40.0 % ) disrupted plications in the open group ( P = 0.0152 ) . There were 10 incisional hernias in the open group compared with none in the LAP group ( P < 0.001 ) . Conclusions : At long-term follow-up , the open and LAP approaches for the Nissen fundoplication have similar long-term subjective symptomatic outcome despite the significantly higher incidence of incisional hernias and defective fundic wraps at endoscopy in the open group defining laparoscopic Nissen fundoplication as the procedure of choice in surgical management of gastroesophageal reflux disease Although Nissen fundoplication is a very effective treatment for gastroesophageal reflux , it is associated with a small incidence of troublesome postoperative side effects . To prevent this , progressive modification of surgical techniques has led to the development of an anterior 90 degrees fundoplication . We undertook a prospect i ve r and omized trial to compare this procedure with Nissen fundoplication to determine whether it would achieve a better clinical outcome . Patients presenting to a single center for primary laparoscopic antireflux surgery were r and omized to undergo either an anterior 90 degrees fundoplication ( n = 40 ) or a Nissen fundoplication without division of the short gastric vessels ( n = 39 ) . Clinical question naires were used to assess outcome at 1 month , 3 - 6 months , and 12 months . Both patients and the clinical interviewer were masked as to which procedure was performed . Follow-up with endoscopy , esophageal manometry , and pH monitoring was also undertaken . Operating time was similar for the two procedures ( 60 minutes for anterior vs. 55 minutes for Nissen fundoplication ) . Early postoperative complications were more common after Nissen fundoplication ( 18 % vs. 5 % ) . Two patients underwent laparoscopic reoperation for recurrent reflux after anterior 90 degrees fundoplication , and four underwent laparoscopic reoperation after Nissen fundoplication ( dysphagia , 3 patients ; acute hiatus hernia , 1 patient ) . One year after surgery , dysphagia and other wind-related side effects were less common after anterior 90 degrees fundoplication . Control of reflux symptoms and satisfaction with the overall outcome was similar for the two procedures . Anterior 90 degrees fundoplication is followed by fewer side effects than Nissen fundoplication . This advantage is offset by a greater likelihood of reflux recurrence . However , this does not diminish patient satisfaction 5Although electronic search ing and publishing have made it easier to identify and obtain a report of a single r and omised trial , this can not be deemed a short-cut to obtaining an overall , balanced view of the effectiveness of the interventions investigated in the trial . Instead , similar trials need to be brought together . This bringing together needs to be done in as unbiased a way as possible . Traditional narrative review s , usually written by a recognised expert , are generally not systematic . Authors might simply not have the time to identify and bring together all relevant studies or they might actually seek to discuss and selectively combine trials that confirm their opinions and prejudices . A systematic review aims to circumvent this weakness by the use of a predefined , explicit methodology . The methods used include steps to minimise bias in the identification of relevant studies , in the selection criteria for inclusion , and in the collection of data . Guidance is available on the conduct , Background : The aim of the study was to compare the effect of laparoscopic anterior and posterior fundoplication on gastro‐oesophageal reflux disease by means of a prospect i ve r and omized controlled trial |
1,338 | 31,240,841 | In conclusion , use of dabigatran in prior VKA users in clinical practice was associated with a slightly increased risk of arterial thromboembolism and gastrointestinal bleeding , but a decreased risk of intracranial bleeding . | A substantial proportion of atrial fibrillation patients initiating direct oral anticoagulants ( DOAC ) are vitamin K antagonists (VKA)-experienced , e.g. , switchers from VKA to DOAC .
With this study , we aim ed to summarize available evidence on the effectiveness and safety of DOAC vs. VKA in real-life VKA-experienced atrial fibrillation patients . | BACKGROUND In ROCKET AF ( Rivaroxaban Once-Daily , Oral , Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ) , a large r and omized , clinical trial , rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation . OBJECTIVE To determine the efficacy and safety of rivaroxaban compared with warfarin among vitamin K antagonist (VKA)-naive and VKA-experienced patients . DESIGN Prespecified subgroup analysis . ( Clinical Trials.gov : NCT00403767 ) . SETTING Global . PATIENTS 14,264 persons with atrial fibrillation . MEASUREMENTS Interaction of the relative treatment effect of rivaroxaban and warfarin on stroke or systemic embolism among VKA-naive and VKA-experienced patients . RESULTS Overall , 7897 ( 55.4 % ) patients were VKA-experienced and 6367 ( 44.6 % ) were VKA-naive . The effect of rivaroxaban versus warfarin on stroke or systemic embolism was consistent : Rates per 100 patient-years of follow-up were 2.32 versus 2.87 for VKA-naive patients ( hazard ratio [ HR ] , 0.81 [ 95 % CI , 0.64 to 1.03 ] ) and 1.98 versus 2.09 for VKA-experienced patients ( HR , 0.94 [ CI , 0.75 to 1.18 ] ; interaction P = 0.36 ) . During the first 7 days , rivaroxaban was associated with more bleeding than warfarin ( HR in VKA-naive patients , 5.83 [ CI , 3.25 to 10.44 ] , and in VKA-experienced patients , 6.66 [ CI , 3.83 to 11.58 ] ; interaction P = 0.53 ) . After 30 days , rivaroxaban was associated with less bleeding than warfarin in VKA-naive patients ( HR , 0.84 [ CI , 0.74 to 0.95 ] ) and similar bleeding in VKA-experienced patients ( HR , 1.06 [ CI , 0.96 to 1.17 ] ; interaction P = 0.003 ) . LIMITATION The trial was not design ed to detect differences in these subgroups . CONCLUSION The efficacy of rivaroxaban in VKA-experienced and VKA-naive patients was similar to that of the overall trial . There were more bleeding events within 7 days of study drug initiation with rivaroxaban , but after 30 days , rivaroxaban was associated with less bleeding in VKA-naive patients and similar bleeding in VKA-experienced patients . This information may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy . PRIMARY FUNDING SOURCE Johnson & Johnson and Bayer HealthCare BACKGROUND Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use . Dabigatran is a new oral direct thrombin inhibitor . METHODS In this noninferiority trial , we r and omly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive , in a blinded fashion , fixed doses of dabigatran--110 mg or 150 mg twice daily -- or , in an unblinded fashion , adjusted-dose warfarin . The median duration of the follow-up period was 2.0 years . The primary outcome was stroke or systemic embolism . RESULTS Rates of the primary outcome were 1.69 % per year in the warfarin group , as compared with 1.53 % per year in the group that received 110 mg of dabigatran ( relative risk with dabigatran , 0.91 ; 95 % confidence interval [ CI ] , 0.74 to 1.11 ; P<0.001 for noninferiority ) and 1.11 % per year in the group that received 150 mg of dabigatran ( relative risk , 0.66 ; 95 % CI , 0.53 to 0.82 ; P<0.001 for superiority ) . The rate of major bleeding was 3.36 % per year in the warfarin group , as compared with 2.71 % per year in the group receiving 110 mg of dabigatran ( P=0.003 ) and 3.11 % per year in the group receiving 150 mg of dabigatran ( P=0.31 ) . The rate of hemorrhagic stroke was 0.38 % per year in the warfarin group , as compared with 0.12 % per year with 110 mg of dabigatran ( P<0.001 ) and 0.10 % per year with 150 mg of dabigatran ( P<0.001 ) . The mortality rate was 4.13 % per year in the warfarin group , as compared with 3.75 % per year with 110 mg of dabigatran ( P=0.13 ) and 3.64 % per year with 150 mg of dabigatran ( P=0.051 ) . CONCLUSIONS In patients with atrial fibrillation , dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin , as well as lower rates of major hemorrhage . Dabigatran administered at a dose of 150 mg , as compared with warfarin , was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage . ( Clinical Trials.gov number , NCT00262600 . BACKGROUND Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects . The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known . METHODS We conducted a r and omized , double-blind , double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation ( median follow-up , 2.8 years ) . The primary efficacy end point was stroke or systemic embolism . Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period . The principal safety end point was major bleeding . RESULTS The annualized rate of the primary end point during treatment was 1.50 % with warfarin ( median time in the therapeutic range , 68.4 % ) , as compared with 1.18 % with high-dose edoxaban ( hazard ratio , 0.79 ; 97.5 % confidence interval [ CI ] , 0.63 to 0.99 ; P<0.001 for noninferiority ) and 1.61 % with low-dose edoxaban ( hazard ratio , 1.07 ; 97.5 % CI , 0.87 to 1.31 ; P=0.005 for noninferiority ) . In the intention-to-treat analysis , there was a trend favoring high-dose edoxaban versus warfarin ( hazard ratio , 0.87 ; 97.5 % CI , 0.73 to 1.04 ; P=0.08 ) and an unfavorable trend with low-dose edoxaban versus warfarin ( hazard ratio , 1.13 ; 97.5 % CI , 0.96 to 1.34 ; P=0.10 ) . The annualized rate of major bleeding was 3.43 % with warfarin versus 2.75 % with high-dose edoxaban ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.91 ; P<0.001 ) and 1.61 % with low-dose edoxaban ( hazard ratio , 0.47 ; 95 % CI , 0.41 to 0.55 ; P<0.001 ) . The corresponding annualized rates of death from cardiovascular causes were 3.17 % versus 2.74 % ( hazard ratio , 0.86 ; 95 % CI , 0.77 to 0.97 ; P=0.01 ) , and 2.71 % ( hazard ratio , 0.85 ; 95 % CI , 0.76 to 0.96 ; P=0.008 ) , and the corresponding rates of the key secondary end point ( a composite of stroke , systemic embolism , or death from cardiovascular causes ) were 4.43 % versus 3.85 % ( hazard ratio , 0.87 ; 95 % CI , 0.78 to 0.96 ; P=0.005 ) , and 4.23 % ( hazard ratio , 0.95 ; 95 % CI , 0.86 to 1.05 ; P=0.32 ) . CONCLUSIONS Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes . ( Funded by Daiichi Sankyo Pharma Development ; ENGAGE AF-TIMI 48 Clinical Trials.gov number , NCT00781391 . ) BACKGROUND Stroke and systemic thromboembolism are serious problems for patients with atrial fibrillation ( AF ) , but their incidence can be substantially reduced by appropriate anticoagulation . Bleeding is the major complication of anticoagulant treatment , and the relative risks for bleeding vs stroke must be considered when starting anticoagulation . METHODS The AFFIRM trial included patients with AF and at least one risk factor for stroke , r and omly assigning them to either a rate-control or rhythm-control strategy . All patients were initially treated with warfarin . The incidence of protocol -defined major and minor bleeding was documented during follow-up . Variables associated with bleeding were determined using a Cox proportional hazards model , using baseline and time-dependent covariates . RESULTS The 4060 patients in the AFFIRM trial were followed for an average of 3.5 years . Major bleeding occurred in 260 patients , an annual incidence of approximately 2 % per year , with no significant difference between the rate-control and rhythm-control groups . Increased age , heart failure , hepatic or renal disease , diabetes , first AF episode , warfarin use , and aspirin use were significantly associated with major bleeding . Minor bleeding was common in both treatment arms , with 738 patients reporting this problem in one or more visits . CONCLUSIONS Bleeding is a significant problem that complicates management of patients with AF . Risk factors for bleeding can be identified , and knowledge of these risk factors can be used to plan therapy CONTEXT In patients with nonvalvular atrial fibrillation , warfarin prevents ischemic stroke , but dose adjustment , coagulation monitoring , and bleeding limit its use . OBJECTIVE To compare the efficacy of the oral direct thrombin inhibitor ximelagatran with warfarin for prevention of stroke and systemic embolism . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , multicenter trial ( 2000 - 2001 ) conducted at 409 North American sites , involving 3922 patients with nonvalvular atrial fibrillation and additional stroke risk factors . INTERVENTIONS Adjusted-dose warfarin ( aim ing for an international normalized ratio [ INR ] 2.0 to 3.0 ) or fixed-dose oral ximelagatran , 36 mg twice daily . MAIN OUTCOME MEASURES The primary end point was all strokes ( ischemic or hemorrhagic ) and systemic embolic events . The primary analysis was based on demonstrating noninferiority within an absolute margin of 2.0 % per year according to the intention-to-treat model . RESULTS During 6405 patient-years ( mean 20 months ) of follow-up , 88 patients experienced primary events . The mean ( SD ) INR with warfarin ( 2.4 [ 0.8 ] ) was within target during 68 % of the treatment period . The primary event rate with ximelagatran was 1.6 % per year and with warfarin was 1.2 % per year ( absolute difference , 0.45 % per year ; 95 % confidence interval , -0.13 % to 1.03 % per year ; P<.001 for the predefined noninferiority hypothesis ) . When all-cause mortality was included in addition to stroke and systemic embolic events , the rate difference was 0.10 % per year ( 95 % confidence interval , -0.97 % to 1.2 % per year ; P = .86 ) . There was no difference between treatment groups in rates of major bleeding , but total bleeding ( major and minor ) was lower with ximelagatran ( 37 % vs 47 % per year ; 95 % confidence interval for the difference , -14 % to -6.0 % per year ; P<.001 ) . Serum alanine aminotransferase levels rose to greater than 3 times the upper limit of normal in 6.0 % of patients treated with ximelagatran , usually within 6 months and typically declined whether or not treatment continued ; however , one case of documented fatal liver disease and one other suggestive case occurred . CONCLUSIONS The results establish the efficacy of fixed-dose oral ximelagatran without coagulation monitoring compared with well-controlled warfarin for prevention of thromboembolism in patients with atrial fibrillation requiring chronic anticoagulant therapy , but the potential for hepatotoxicity requires further investigation The pivotal r and omized clinical trials ( RCTs ) of non – vitamin K antagonist oral anticoagulants ( NOACs ) for stroke prevention in atrial fibrillation ( AF ) established the efficacy and safety of these drugs for patients with AF without mechanical prosthetic heart valves or significant ( rheumatic ) mitral valve stenosis.1 A clinical trial setting with strict inclusion and exclusion criteria was needed to obtain high- quality scientific evidence on the effects of NOACs compared with st and ard care ( ie , warfarin ) , but these results in highly selected trial cohorts may not be fully applicable to a diversity of patients or clinical circumstances encountered in daily practice BACKGROUND Effectiveness and safety of warfarin is associated with the time in therapeutic range ( TTR ) with an international normalised ratio ( INR ) of 2·0 - 3·0 . In the R and omised Evaluation of Long-term Anticoagulation Therapy ( RE-LY ) trial , dabigatran versus warfarin reduced both stroke and haemorrhage . We aim ed to investigate the primary and secondary outcomes of the RE-LY trial in relation to each centre 's mean TTR ( cTTR ) in the warfarin population . METHODS In the RE-LY trial , 18 113 patients at 951 sites were r and omly assigned to 110 mg or 150 mg dabigatran twice daily versus warfarin dose adjusted to INR 2·0 - 3·0 . Median follow-up was 2·0 years . For 18 024 patients at 906 sites , the cTTR was estimated by averaging TTR for individual warfarin-treated patients calculated by the Rosendaal method . We compared the outcomes of RE-LY across the three treatment groups within four groups defined by the quartiles of cTTR . RE-LY is registered with Clinical Trials.gov , number NCT00262600 . FINDINGS The quartiles of cTTR for patients in the warfarin group were : less than 57·1 % , 57·1 - 65·5 % , 65·5 - 72·6 % , and greater than 72·6 % . There were no significant interactions between cTTR and prevention of stroke and systemic embolism with either 110 mg dabigatran ( interaction p=0·89 ) or 150 mg dabigatran ( interaction p=0·20 ) versus warfarin . Neither were any significant interactions recorded with cTTR with regards to intracranial bleeding with 110 mg dabigatran ( interaction p=0·71 ) or 150 mg dabigatran ( interaction p=0·89 ) versus warfarin . There was a significant interaction between cTTR and major bleeding when comparing 150 mg dabigatran with warfarin ( interaction p=0·03 ) , with less bleeding events at lower cTTR but similar events at higher cTTR , whereas rates of major bleeding were lower with 110 mg dabigatran than with warfarin irrespective of cTTR . There were significant interactions between cTTR and effects of both 110 mg and 150 mg dabigatran versus warfarin on the composite of all cardiovascular events ( interaction p=0·036 and p=0·0006 , respectively ) and total mortality ( interaction p=0·066 and p=0·052 , respectively ) with reduced event rates at low cTTR , and similar rates at high cTTR . INTERPRETATION The benefits of 150 mg dabigatran at reducing stroke , 110 mg dabigatran at reducing bleeding , and both doses at reducing intracranial bleeding versus warfarin were consistent irrespective of centres ' quality of INR control . For all vascular events , non-haemorrhagic events , and mortality , advantages of dabigatran were greater at sites with poor INR control than at those with good INR control . Overall , these results show that local st and ards of care affect the benefits of use of new treatment alternatives . FUNDING Boehringer Ingelheim BACKGROUND The Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation ( GLORIA-AF ) was design ed to provide prospect ively collected information on patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke , with the aim of addressing treatment patterns and questions of effectiveness and safety . METHODS AND RESULTS In this predefined analysis from GLORIA-AF , the baseline characteristics and initial antithrombotic management of the first 10,000 patients in Phase II of this large Registry Program are presented . Overall , 32.3 % of patients received vitamin K antagonists ( VKAs ) and 47.7 % received non-VKA oral anticoagulants ( NOACs ) , while 12.3 % received antiplatelet treatment and 7.6 % did not receive any antithrombotic treatment . Among patients with CHA2DS2-VASc score ≥2 , 6.7 % received no antithrombotic treatment and 10.0 % received aspirin . In Europe , treatment with dabigatran was as common as treatment with VKAs ( 38.8 % and 37.8 % , respectively ) . More than half of the patients were treated with NOACs ( 52.4 % ) , while antiplatelet treatment was given to 5.7 % , and 4.1 % did not receive any antithrombotic treatment . In North America , treatment with dabigatran ( 25.0 % ) was as common as with VKAs ( 26.1 % ) , but overall NOAC use was more common ( 52.1 % ) than with VKAs ( 26.1 % ) ; however , 14.1 % received antiplatelet treatment , while 7.6 % received no antithrombotic treatment . In Asia , treatment with VKAs ( 31.9 % ) was more prevalent than NOACs ( 25.5 % ) , but antiplatelet treatment was given to 25.8 % , and 16.9 % did not receive any antithrombotic treatment . In Asia , only 60.7 % of patients with high stroke risk received oral anticoagulants ( OACs ) . Paroxysmal atrial fibrillation and minimally symptomatic ( or asymptomatic ) patients were often undertreated with OACs . CONCLUSION In this analysis , OAC use was high in Europe and North America , with overall NOAC use higher than VKA use . A considerable percentage of high-risk patients in North America still received antiplatelet treatment or were untreated , while Asian patients had a high proportion of aspirin use and nontreatment BACKGROUND Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation . However , many patients are not suitable c and i date s for or are unwilling to receive vitamin K antagonist therapy , and these patients have a high risk of stroke . Apixaban , a novel factor Xa inhibitor , may be an alternative treatment for such patients . METHODS In a double-blind study , we r and omly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban ( at a dose of 5 mg twice daily ) or aspirin ( 81 to 324 mg per day ) , to determine whether apixaban was superior . The mean follow up period was 1.1 years . The primary outcome was the occurrence of stroke or systemic embolism . RESULTS Before enrollment , 40 % of the patients had used a vitamin K antagonist . The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban . There were 51 primary outcome events ( 1.6 % per year ) among patients assigned to apixaban and 113 ( 3.7 % per year ) among those assigned to aspirin ( hazard ratio with apixaban , 0.45 ; 95 % confidence interval [ CI ] , 0.32 to 0.62 ; P<0.001 ) . The rates of death were 3.5 % per year in the apixaban group and 4.4 % per year in the aspirin group ( hazard ratio , 0.79 ; 95 % CI , 0.62 to 1.02 ; P=0.07 ) . There were 44 cases of major bleeding ( 1.4 % per year ) in the apixaban group and 39 ( 1.2 % per year ) in the aspirin group ( hazard ratio with apixaban , 1.13 ; 95 % CI , 0.74 to 1.75 ; P=0.57 ) ; there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin . The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin ( 12.6 % per year vs. 15.9 % per year , P<0.001 ) . The treatment effects were consistent among important subgroups . CONCLUSIONS In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable , apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage . ( Funded by Bristol-Myers Squibb and Pfizer ; Clinical Trials.gov number , NCT00496769 . ) AIMS Edoxaban is an oral , once-daily factor Xa inhibitor that is non-inferior to well-managed warfarin in patients with atrial fibrillation ( AF ) for the prevention of stroke and systemic embolic events ( SEEs ) . We examined the efficacy and safety of edoxaban vs. warfarin in patients who were vitamin K antagonist ( VKA ) naive or experienced . METHODS AND RESULTS ENGAGE AF-TIMI 48 r and omized 21 105 patients with AF at moderate-to-high risk of stroke to once-daily edoxaban vs. warfarin . Subjects were followed for a median of 2.8 years . The primary efficacy endpoint was stroke or SEE . As a pre-specified subgroup , we analysed outcomes for those with or without prior VKA experience ( > 60 consecutive days ) . Higher-dose edoxaban significantly reduced the risk of stroke or SEE in patients who were VKA naive [ hazard ratio ( HR ) 0.71 , 95 % confidence interval ( CI ) 0.56 - 0.90 ] and was similar to warfarin in the VKA experienced ( HR 1.01 , 95 % CI 0.82 - 1.24 ; P interaction = 0.028 ) . Lower-dose edoxaban was similar to warfarin for stroke or SEE prevention in patients who were VKA naive ( HR 0.92 , 95 % CI 0.73 - 1.15 ) , but was inferior to warfarin in those who were VKA experienced ( HR 1.31 , 95 % 1.08 - 1.60 ; P interaction = 0.019 ) . Both higher-dose and lower-dose edoxaban regimens significantly reduced the risk of major bleeding regardless of prior VKA experience ( P interaction = 0.90 and 0.71 , respectively ) . CONCLUSION In patients with AF , edoxaban appeared to demonstrate greater efficacy compared with warfarin in patients who were VKA naive than VKA experienced . Edoxaban significantly reduced major bleeding compared with warfarin regardless of prior VKA exposure BACKGROUND At the end of 2 previous trials , an excess of stroke and bleeding was observed in patients with AF r and omized to a new oral anticoagulant ( NOAC ) who transitioned to a vitamin K antagonist ( VKA ) . OBJECTIVES The ENGAGE AF-TIMI 48 ( Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infa rct ion 48 ) trial compared once-daily edoxaban to warfarin for stroke prevention in patients with AF . An end-of-trial transition plan was developed to minimize the risks of stroke due to inadequate anticoagulation and bleeding from excessive anticoagulation during this critical period . METHODS All patients on the blinded study drug at the trial 's conclusion were included in this analysis . In pre-specified analyses , stroke , bleeding , and death that occurred through 30 days after the end-of-trial visit were stratified by r and omized treatment allocation and open-label anticoagulant selected post-trial . RESULTS Of the 13,642 patients taking the blinded study drug at the end of the trial , 9,304 ( 68.2 % ) were transitioned to open-label VKA and 4,258 patients ( 31.2 % ) to an NOAC . There were 21 strokes evenly distributed across the 3 r and omized treatment arms : warfarin 7 ( 1.90%/year ) , edoxaban high dose 7 ( 1.89%/year ) , edoxaban low dose 7 ( 1.85%/year ) . Major bleeding was also similar across the 3 treatment arms : warfarin 11 ( 2.98%/year ) , edoxaban high dose 10 ( 2.69%/year ) , edoxaban low dose 18 ( 4.76%/year ) . In patients transitioned to VKA , 85 % of patients had at least 1 INR ≥ 2 by day 14 after the transition and 99 % by day 30 . CONCLUSIONS The ENGAGE AF-TIMI 48 transition plan protected patients from an excess of thrombotic and bleeding events and should be helpful in clinical practice when patients are transitioned between oral anticoagulants . ( Global Study to Assess the Safety and Effectiveness of Edoxaban [ DU-176b ] vs St and ard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [ EngageAFTIMI48 ] ; NCT00781391 ) |
1,339 | 18,843,625 | Sealing is a recommended procedure to prevent caries of the occlusal surfaces of permanent molars . | BACKGROUND Although pit and fissure sealants are effective in preventing caries , their efficacy may be related to the caries prevalence in the population .
OBJECTIVES The primary objective of this review was to evaluate the caries prevention of pit and fissure sealants in children and adolescents . | PURPOSE To evaluate the clinical performance of Helioseal-F , a fluoride-containing fissure sealant , in school children at caries risk . MATERIAL S AND METHODS A caries risk assessment based on past caries experience , saliva microbial tests , buffer capacity and frequency of sugar intake was carried out in 204 healthy children , 6 - 7 years of age . Children exhibiting one or more risk factors were considered at caries risk ( n = 121 ) and their permanent molars were sealed with a fluoride-containing fissure sealant , thus forming a fissure sealant group ( FSG ) . The remaining 83 children with low caries risk received no fissure sealants and constituted a reference group ( RG ) . Both groups were followed for 2 years . From 15 children of both groups , unstimulated whole saliva was collected 1 month after sealant placement in order to determine fluoride levels . In another 20 children , a split-mouth study design was utilized to compare the colonization of mutans streptococci adjacent to and on F-containing sealants and conventional controls . The sealants were placed by dental hygienists according to the manufacturers ' instructions . RESULTS A total of 431 fissure sealants were placed at baseline . Complete retention was found in 76.6 % during the study period while 22.0 % were partially lost . Six sealants ( 1.4 % ) were completely lost . The enamel caries incidence was 45 % lower ( P < 0.05 ) in the permanent molars of the caries risk FSG compared with the low risk RG . There was no significant increase in saliva fluoride concentration following placement of the sealants and the proportion of mutans streptococci in relation to total viable counts was unaffected by type of material . The levels of salivary mutans streptococci were mainly unchanged in both groups during the study period , while the levels of salivary lactobacilli decreased in the FSG The aim of this study was to compare the retention and caries preventive efficacy of glass ionomer ( Fuji III ; GIC ) and light-cured resin-based ( Delton ; LCR ) fissure sealants . One hundred and sixty-six 5 - 14-year-old schoolchildren received sealants on their newly erupted first or second molars ; a split mouth design was used . Previously reported 2-year results showed low retention rates for GIC sealants , but no difference in the caries increment between the groups . The same persons were invited to a dental check-up 6.1 to 7.8 ( mean 7.1 ) years after the application of sealants ; 111 persons ( 66.8 % of the original group ) participated in the study . The retention of sealants , and the caries status of occlusal surfaces and adjacent proximal surfaces was recorded . On the sealed occlusal surfaces , 10 % of GIC and 45 % of LCR sealants were totally and 9 % of GIC and 20 % of LCR sealants partially present . Twenty-three ( 23.5 % ) of the occlusal surfaces sealed with GIC and 16 ( 16.5 % ) of those sealed with LCR were carious or filled . Compared to LCR sealants , the effectiveness of GIC sealants was -44 % ( 95 % CI -71 % , -16 % ) and net gain -7 % ( 95 % CI -18 % , 4 % ) . The relative risk of caries occurring was 1.44 ( 95 % CI 0.96 , 2.14 ) |
1,340 | 20,166,083 | No difference in breakthrough fungal infection was observed in children with prolonged fever and neutropenia .
Limited paediatric data are available comparing antifungal agents in children with proven , probable or suspected invasive fungal infection .
No differences in mortality or treatment efficacy were observed when antifungal agents were compared . | BACKGROUND Invasive fungal infections are associated with significant morbidity and mortality in children .
Optimal treatment strategies are yet to be defined .
OBJECTIVES This review aims to systematic ally identify and summarise the effects of different antifungal therapies in children with proven , probable or suspected invasive fungal infections . | PURPOSE To compare the efficacy and safety of fluconazole and amphotericin B as empiric antifungal therapy of febrile neutropenic patients with cancer . PATIENTS AND METHODS A total of 317 neutropenic patients ( < 500 cells/mm3 ) with persistent or recrudescent fever despite 4 or more days of antibacterial therapy were r and omly assigned to receive either fluconazole ( 400 mg intravenously once daily ) or amphotericin B ( 0.5 mg/kg once daily ) . Patients were evaluated for the efficacy and safety of each drug by clinical criteria , frequent cultures and radiological procedures , and laboratory values . A response was classified as satisfactory at the end of therapy if the patient was afebrile , had no clinical or microbiological evidence of fungal infection , and did not require study termination due to lack of efficacy , drug toxicity , or death . RESULTS A satisfactory response occurred in 68 % of the patients treated with fluconazole ( 107 of 158 patients ) and in 67 % of patients treated with amphotericin B ( 106 of 159 patients ) . Progressive or new fungal infections during therapy occurred in 13 ( 8 % ) patients treated with fluconazole ( 8 with C and ida , 5 with Aspergillus ) and in 10 ( 6 % ) patients treated with amphotericin B ( 5 with C and ida , 3 with Aspergillus , 2 with other fungi ) . Adverse events related to study drug ( especially fever , chills , renal insufficiency , electrolyte disturbances , and respiratory distress ) occurred more often in patients treated with amphotericin B ( 128 [ 81 % ] of 159 patients ) than patients treated with fluconazole ( 20 [ 13 % ] of 158 patients , P = 0.001 ) . Eleven ( 7 % ) patients treated with amphotericin B but only 1 ( 1 % ) patient treated with fluconazole were terminated from the study owing to an adverse event ( P = 0.005 ) . Overall mortality ( 27 [ 17 % ] patients treated with fluconazole versus 34 [ 21 % ] patients treated with amphotericin B ) and mortality from fungal infection ( 7 [ 4 % ] patients treated with fluconazole versus 5 [ 3 % ] patients treated with amphotericin B ) were similar in each study group . CONCLUSIONS Intravenous fluconazole can be an effective and safe alternative to amphotericin B for empiric antifungal therapy in many febrile neutropenic patients . However , because fluconazole may be ineffective in the treatment of Aspergillus , patients at risk for that infection should be evaluated by chest radiograph , computed tomographic scanning , and cultures before the use of empiric fluconazole therapy BACKGROUND Voriconazole is a broad-spectrum triazole that is active against aspergillus species . We conducted a r and omized trial to compare voriconazole with amphotericin B for primary therapy of invasive aspergillosis . METHODS In this r and omized , unblinded trial , patients received either intravenous voriconazole ( two doses of 6 mg per kilogram of body weight on day 1 , then 4 mg per kilogram twice daily for at least seven days ) followed by 200 mg orally twice daily or intravenous amphotericin B deoxycholate ( 1 to 1.5 mg per kilogram per day ) . Other licensed antifungal treatments were allowed if the initial therapy failed or if the patient had an intolerance to the first drug used . A complete or partial response was considered to be a successful outcome . RESULTS A total of 144 patients in the voriconazole group and 133 patients in the amphotericin B group with definite or probable aspergillosis received at least one dose of treatment . In most of the patients , the underlying condition was allogeneic hematopoietic-cell transplantation , acute leukemia , or other hematologic diseases . At week 12 , there were successful outcomes in 52.8 percent of the patients in the voriconazole group ( complete responses in 20.8 percent and partial responses in 31.9 percent ) and 31.6 percent of those in the amphotericin B group ( complete responses in 16.5 percent and partial responses in 15.0 percent ; absolute difference , 21.2 percentage points ; 95 percent confidence interval , 10.4 to 32.9 ) . The survival rate at 12 weeks was 70.8 percent in the voriconazole group and 57.9 percent in the amphotericin B group ( hazard ratio , 0.59 ; 95 percent confidence interval , 0.40 to 0.88 ) . Voriconazole-treated patients had significantly fewer severe drug-related adverse events , but transient visual disturbances were common with voriconazole ( occurring in 44.8 percent of patients ) . CONCLUSIONS In patients with invasive aspergillosis , initial therapy with voriconazole led to better responses and improved survival and result ed in fewer severe side effects than the st and ard approach of initial therapy with amphotericin BACKGROUND Aspergillosis therapy with amphotericin , azoles , or echinoc and ins is associated with substantial mortality , ranging from 30 % to 80 % , depending on the stage of infection and the host 's underlying disease . The results of in vitro studies and animal models suggest that combination therapy with azoles and echinoc and ins may have additive activity against Aspergillus species . METHODS We evaluated the outcomes of patients with aspergillosis who experienced failure of initial therapy with amphotericin B formulations and received either voriconazole ( n=31 ) or a combination of voriconazole and caspofungin ( n=16 ) for salvage therapy . RESULTS The combination of voriconazole and caspofungin was associated with improved 3-month survival rate , compared with voriconazole alone ( hazard ratio [ HR ] , 0.42 ; 95 % confidence interval [ CI ] , 0.17 - 1.1 ; P=.048 ) . In multivariable models , salvage therapy with the combination of voriconazole and caspofungin was associated with reduced mortality , compared with therapy with voriconazole ( HR , 0.28 ; 95 % CI , 0.28 - 0.92 ; P=.011 ) , independent of other prognostic variables ( e.g. , receipt of transplant and type of conditioning therapy ) . The probability of death due to aspergillosis was lowest in patients who received the combination regimen . CONCLUSIONS R and omized trials are warranted to determine whether this combination should be used as primary therapy for aspergillosis Background : Invasive c and idiasis is increasingly prevalent in premature infants and seriously ill children , and pediatric data on available antifungal therapies are lacking . Methods : We conducted a pediatric sub study as part of a double-blind , r and omized , multinational trial to compare micafungin ( 2 mg/kg ) with liposomal amphotericin B ( 3 mg/kg ) as first-line treatment of invasive c and idiasis . Treatment success was defined as clinical and mycologic response at the end of therapy . Statistical analyses were descriptive , as the sample size meant that the study was not powered for hypothesis testing . Results : One hundred six patients were included in the intent-to-treat population ; and 98 patients —48 patients in the micafungin group and 50 patients in the liposomal amphotericin B group — in the modified intent-to-treat population . Baseline characteristics were balanced between treatment groups . Overall , 57 patients were < 2 years old including 19 patients who were premature at birth ; and 41 patients were 2 to < 16 years old . Most patients ( 91/98 , 92.9 % ) had c and idemia , and 7/98 ( 7.1 % ) patients had other forms of invasive c and idiasis . Treatment success was observed for 35/48 ( 72.9 % ) patients treated with micafungin and 38/50 ( 76.0 % ) patients treated with liposomal amphotericin B. The difference in proportions adjusted for neutropenic status was −2.4 % [ 95 % CI : ( −20.1 to 15.3 ) ] . Efficacy findings were consistent , independent of the neutropenic status , the age of the patient , and whether the patient was premature at birth . Both treatments were well tolerated , but with a lower incidence of adverse events that led to discontinuation in the micafungin group ( 2/52 , 3.8 % ) compared with the liposomal amphotericin B group ( 9/54 , 16.7 % ) ( P = 0.05 , Fisher exact test ) . Conclusions : Micafungin seems to be similarly effective and as safe as liposomal amphotericin B for the treatment of invasive c and idiasis in pediatric patients . ( Clinical Trials.gov number , NCT00106288 ) The epidemiology , management , and long-term survival of invasive aspergillosis was assessed in a prospect i ve , 5-year observational study in 346 unselected paediatric cancer patients receiving dose-intensive chemotherapy for newly diagnosed or recurrent malignancies . Invasive aspergillosis occurred exclusively in the context of haematological malignancies , where it accounted for an incidence of 6.8 % ( n = 13 of 189 ) . The lung was the primary site in 12 cases , and dissemination was present in three of those . Prior to diagnosis , the overwhelming majority of patients had been profoundly neutropenic for at least 14 days ( n = 11 of 13 ) and were receiving systemic antifungal agents ( n = 10 of 13 ) . Clinical signs and symptoms were nonspecific but always included fever . All 11 patients who were diagnosed and treated during lifetime for a minimum of 10 days responded to either medical or combined medical and surgical treatment , and seven were cured ( 64 % ) . Nevertheless , the overall long-term survival was merely 31 % after a median follow-up of 5.68 years after diagnosis . Apart from refractory or recurrent cancer , the main obstacles to successful outcome were failure to diagnose IA during lifetime and bleeding complications in patients with established diagnosis . The frequency of invasive aspergillosis of greater than 15 % in paediatric patients with acute myeloblastic leukaemia and recurrent leukaemias warrants the systematic investigation of preventive strategies in these highly vulnerable subgroups Coccidioidomycosis is a systemic fungal infection caused by Coccidioides immitis . Typically , infection stimulates a protective immune response that limits the initial illness and confers lifelong resistance to subsequent infections ( 1 ) . Occasionally , however , illness progresses , either as a fibrocavitary chronic pneumonia or hematogenously , with dissemination of infection to such extrathoracic sites as the skin , bones , or joints ( 2 , 3 ) . If these complications occur , antifungal therapy is warranted to prevent further tissue destruction and associated morbidity ( 4 ) . Azole antifungal agents have become valuable in treating progressive forms of coccidioidomycosis , especially when disease manifestations are not fulminant or immediately life-threatening . Originally , the U.S. Food and Drug Administration approved intravenous miconazole and oral ketoconazole for this indication on the basis of their efficacy and safety ( 5 - 14 ) . The lack of an oral form of miconazole and untoward effects or drug intolerance related to both agents led to the development of fluconazole , itraconazole , and related congeners . These new drugs have shown therapeutic efficacy against coccidioidomycosis in experimental infections of animals ( 15 - 20 ) and in subsequent clinical trials ( 21 - 30 ) . Our current underst and ing of optimal management of coccidioidal infections is severely limited by the absence of r and omized comparative trials that evaluate the different forms of therapy . Multicenter comparative trials are now possible because over the past decade , the evaluation of patients treated for coccidioidomycosis has become st and ardized . In addition , because of the development of a collaborative group during the same period , trials can now enroll enough patients to support clinical ly applicable results . In this report , we present the findings from Mycoses Study Group Protocol 20 , a comparative trial sponsored by the National Institute of Allergy and Infectious Diseases that compares two antifungal agents , fluconazole and itraconazole , in the treatment of coccidioidomycosis . Methods Patient Eligibility Patients were considered for enrollment if C. immitis was identified by culture , by microscopic examination of infected tissue from outside the lungs , or from respiratory specimens , if a pulmonary infection had persisted for more than 3 months . Patients with HIV infection and pulmonary coccidioidomycosis of shorter duration were eligible if their CD4 count was less than or equal to 0.25 109 cells/L or if they had diffuse bilateral pneumonia . Enrollees had to be able to take oral medications . Pregnant women were excluded , and women of childbearing potential were required to practice an effective method of birth control . Patients who had received more than 4 mg/kg of body weight of amphotericin B or more than 8 g of an azole antifungal agent for the current episode of infection were ineligible . Other exclusion criteria were immediately life-threatening coccidioidomycosis , presence of coccidioidal meningitis , concomitant administration of a non study systemic antifungal drug , history of hypersensitivity to an azole compound , insufficient evidence of infection on which to assess a response to treatment , renal insufficiency ( defined as a serum creatinine concentration>180 mol/L [ 2.0 mg/dL ] ) , or any of the following abnormal laboratory test values at baseline : hemoglobin level less than 4.3 mmol/L ( 7 mg/dL ) , absolute neutrophil count less than 0.8 109 cells/L , platelet count less than 0.5 109 cells/L , liver enzyme levels ( alanine aminotransferase , aspartate aminotransferase , or alkaline phosphatase ) more than 7.5 times the upper limit of normal , or bilirubin level more than 2 times the upper limit of normal . In addition , we excluded patients receiving concomitant medications that could not be managed safely in a blinded study because of potential interactions with the study drugs . The institutional review boards of each participating center approved the study protocol , and signed consent was obtained from each patient before enrollment . R and omization and Management of Therapy This was a double-blind study in which the patient and the investigators were unaware of the identity of the study medications . For patient enrollment , a primary investigator contacted a central study coordinator , who review ed the completeness of the patient 's eligibility and categorized the major site of infection as chronic pulmonary , soft tissue , or skeletal . Patients in each of the three major categories were r and omly assigned to receive fluconazole and itraconazole in a 1:1 ratio . Pharmacists at each participating institution dispensed appropriate medication according to the r and omization code that they had been given . The r and omization code was stored securely by the pharmacists at each study site , and pharmacists never informed patients , investigators , or other clinical personnel of the patient 's design ated treatment . Any requests by the primary investigators for unblinding treatment were h and led by the principal investigator of the Mycoses Study Group , who was not a collaborating investigator of this study . The fluconazole tablets ( supplied by Pfizer , New York , New York ) and itraconazole tablets ( supplied by Janssen Pharmaceutica , Piscataway , New Jersey ) differed in appearance . Therefore , to maintain blinded treatment , a double placebo design was used . Patients r and omly assigned to fluconazole received 400 mg of active fluconazole once daily and placebo itraconazole twice daily . Conversely , patients r and omly assigned to itraconazole received 200 mg of active itraconazole twice daily and placebo fluconazole once daily . Therefore , each patient simultaneously received a combination of an experimental study drug and a placebo . Medications were administered orally with meals . Treatment lasted 8 months before the primary outcome assessment and continued for another 4 months to consoli date a response . Patient Assessment At enrollment , all patients provided a complete history , underwent a physical examination , su bmi tted blood specimens for baseline hematologic and chemistry analyses , and were further evaluated with appropriate imaging procedures to determine the extent of evident infection . A central laboratory determined complement-fixing type anticoccidioidal antibodies in serum specimens by using the quantitative immunodiffusion technique ( 31 ) . Enrolled patients were interviewed and examined at 2 weeks , 4 weeks , 2 months , and every 2 months thereafter while receiving study medication to assess protocol adherence , to determine possible adverse drug effects , and to ensure that the disease was not progressing . Disease activity was assessed at 4 , 8 , and 12 months . For some patients , especially those with skeletal lesions , computed tomography and magnetic resonance imaging studies were used to assess disease activity . To assess the extent of infection , we used a previously described scoring strategy ( 22 ) . In brief , symptoms , appearance of lesions , serum anticoccidioidal antibody titers , and culture results that were repeated during the study were assigned numerical values according to a predefined set of rules . The sum of these values at re assessment during therapy was compared with that determined at enrollment . An increasing score reflected a poorer condition and a decreasing score reflected an improved condition . Response to therapy was defined as a 50 % reduction in baseline abnormalities during the first 8 months of therapy . Relapses were considered to have occurred in responding patients who discontinued all antifungal therapy if therapy was reinstituted because an existing coccidioidal lesion worsened or a new coccidioidal lesion developed . Determination of Serum Drug Concentrations Serum specimens were collected from patients 1 month , 4 months , and 8 months after the start of therapy . Specimens were mailed to a central laboratory and stored at 70 C until protocol therapy was concluded on all patients ; all specimens were then assayed at one time . Fluconazole levels were measured by using gasliquid chromatography ( 32 ) , and itraconazole levels ( itraconazole and hydroxyitraconazole ) were measured by using bioassay ( 33 ) . The lower limit of detection was 0.2 g/mL for fluconazole and 0.5 g/mL for itraconazole . Statistical Analysis The primary null hypothesis , which we hoped to reject , was that the efficacy of fluconazole and itraconazole after 8 months of treatment was equal in favor of the alternative hypothesis ( at least 20 % superiority of one treatment ) . Past studies on nonmeningeal progressive coccidioidomycosis indicated that between 55 % and 65 % of patients should respond to 400 mg of either azole drug per day ( 22 , 29 ) . With a response rate of 55 % , a two-sided type I error of 5 % , and a power of 0.8 , 196 patients would be required to show a 20 % difference in the efficacy of the two treatments . We planned to enroll 4 additional patients to accommo date any ineligible cases ; therefore , accrual was to be 200 patients . Enrollment was closed with 198 patients after reaching a termination date that had been agreed to in advance by the pharmaceutical sponsors , the Mycoses Study Group , and the National Institutes of Health . The primary outcome analysis was performed on an intention-to-treat basis at 8 months on all patients , regardless of whether they reached an end point or discontinued the protocol prematurely . For treatment to be considered successful , a patient had to be evaluated at 8 months and have a score less than or equal to 50 % of the baseline score . Patients who did not meet these criteria were considered to be nonresponding . Consolidation therapy continued for 4 months to complete 1 year of protocol treatment . Two interim analyses were performed during the trial . The levels of significance maintained an overall P value of 0.05 and were calculated according to the O'BrienFleming stopping boundaries . This final analysis used a Z score of 1.985 with an associated P value of 0.0471 ( BACKGROUND Patients with neutropenia and persistent fever are often treated empirically with amphotericin B or liposomal amphotericin B to prevent invasive fungal infections . Antifungal triazoles offer a potentially safer and effective alternative . METHODS In a r and omized , international , multicenter trial , we compared voriconazole , a new second-generation triazole , with liposomal amphotericin B for empirical antifungal therapy . RESULTS A total of 837 patients ( 415 assigned to voriconazole and 422 to liposomal amphotericin B ) were evaluated for success of treatment . The overall success rates were 26.0 percent with voriconazole and 30.6 percent with liposomal amphotericin B ( 95 percent confidence interval for the difference , -10.6 to 1.6 percentage points ) ; these rates were independent of the administration of antifungal prophylaxis or the use of colony-stimulating factors . There were fewer documented breakthrough fungal infections in patients treated with voriconazole than in those treated with liposomal amphotericin B ( 8 [ 1.9 percent ] vs. 21 [ 5.0 percent ] , P=0.02 ) . The voriconazole group had fewer cases of severe infusion-related reactions ( P<0.01 ) and of nephrotoxicity ( P<0.001 ) . The incidence of hepatotoxicity was similar in the two groups . Patients receiving voriconazole had more episodes of transient visual changes than those receiving liposomal amphotericin B ( 22 percent vs. 1 percent , P<0.001 ) and more hallucinations ( 4.3 percent vs. 0.5 percent , P<0.001 ) . Parenteral voriconazole was changed to the oral formulation in 22 percent of the voriconazole group , with a reduction in the mean duration of hospitalization by one day in all patients ( P=0.17 ) but by two days in patients at high risk ( P=0.03 ) . CONCLUSIONS Voriconazole is a suitable alternative to amphotericin B preparations for empirical antifungal therapy in patients with neutropenia and persistent fever We report a r and omized , double-blind , multicenter trial in which amphotericin B colloidal dispersion ( ABCD [ Amphotec ] ; 6 mg/kg/day ) was compared with amphotericin B ( AmB ; 1.0 - 1.5 mg/kg/day ) for the treatment of invasive aspergillosis in 174 patients . For evaluable patients in the ABCD and AmB treatment groups , respective rates of therapeutic response ( 52 % vs. 51 % ; P=1.0 ) , mortality ( 36 % vs. 45 % ; P=.4 ) , and death due to fungal infection ( 32 % vs. 26 % ; P=.7 ) were similar . Renal toxicity was lower ( 25 % vs. 49 % ; P=.002 ) and the median time to onset of nephrotoxicity was longer ( 301 vs. 22 days ; P<.001 ) in patients treated with ABCD . Rates of drug-related toxicity in patients receiving ABCD and AmB , respectively , were 53 % versus 30 % ( chills ) , 27 % versus 16 % ( fever ) , 1 % versus 4 % ( hypoxia ) and 22 % versus 24 % ( toxicity requiring study drug discontinuation ) . ABCD appears to have equivalent efficacy and superior renal safety , compared with AmB , in the treatment of invasive aspergillosis . However , infusion-related chills and fever occurred more frequently in patients receiving ABCD than in those receiving We conducted a prospect i ve , r and omized , double-blind study comparing amphotericin B colloidal dispersion ( ABCD ) with amphotericin B in the empirical treatment of fever and neutropenia . Patients with neutropenia and unresolved fever after > or = 3 days of empirical antibiotic therapy were stratified by age and concomitant use of cyclosporine or tacrolimus . Patients were then r and omized to receive therapy with ABCD ( 4 mg/[kg.d ] ) or amphotericin B ( 0.8 mg/[kg.d ] ) for < or = 14 days . A total of 213 patients were enrolled , of whom 196 were evaluable for efficacy . Fifty percent of ABCD-treated patients and 43.2 % of amphotericin B-treated patients had a therapeutic response ( P = .31 ) . Renal dysfunction was less likely to develop and occurred later in ABCD recipients than in amphotericin B recipients ( P < .001 for both parameters ) . Infusion-related hypoxia and chills were more common in ABCD recipients than in amphotericin B recipients ( P = .013 and P = .018 , respectively ) . ABCD appeared comparable in efficacy with amphotericin B , and renal dysfunction associated with ABCD was significantly less than that associated with amphotericin B. However , infusion-related events were more common with ABCD treatment than with amphotericin B treatment Objective : C and ida bloodstream infections have shown an increase in hospitalized patients , especially those receiving intensive care . The effectiveness of various azoles , especially itraconazole , in treatment of c and idemia has not been fully evaluated . Our objective was to compare the efficacy and safety of enterally administered itraconazole vs. fluconazole in treatment of c and idemia . Design : R and omized , double-blind , controlled trial . Setting : Pediatric intensive care unit of a referral and teaching hospital . Subjects : Forty-three pediatric patients with c and idemia , Intervention : Patients received either fluconazole ( n = 22 ) or itraconazole ( n = 21 ) , about 10 mg/kg orally or through a gastric tube , and were monitored for clinical and mycological cure ( sterile fungal blood culture ) , blood counts , and liver and renal functions . Measurements and Main Results : The clinical characteristics of two groups were comparable . The cure rate was similar in both the groups : itraconazole 17 of 21 ( 81 % ) and fluconazole 18 of 22 ( 82 % ) . Crude mortality rate ( itraconazole 9.5 % and fluconazole 13.6 % ) was also comparable in two groups of patients . The frequency of electrolyte disturbance was very low and similar in both the groups . Blood urea , creatinine , liver enzymes , and serum bilirubin were not adversely affected . Conclusions : Itraconazole was as effective as fluconazole in nosocomial c and idiasis in children receiving intensive care and was devoid of serious side effects PURPOSE To describe the experience with a new lipid-based amphotericin product ( amphotericin B colloidal dispersion or ABCD ) in children with fever and neutropenia who are at high risk for fungal infection . PATIENTS AND METHODS Forty-nine children with febrile neutropenia were treated in a prospect i ve , r and omized trial comparing ABCD with amphotericin B. An additional 70 children with presumed or proven fungal infection were treated with 5 different open-label studies of ABCD . Patients were registered into these studies for reasons of : 1 ) failure to respond to amphotericin B ; 2 ) development of nephrotoxicity or preexisting renal impairment ; or 3 ) willingness to participate in a dose-escalation study . Extensive data detailing response and toxicity were collected from each patient . RESULTS In the r and omized trial , there was significantly less renal toxicity in the children receiving ABCD than in those receiving amphotericin B ( 12.0 % vs. 52.4 % [ P = 0.003 ] ) . Other adverse symptoms were not significantly different . In the additional open-label studies , although 80 % of patients receiving ABCD reported some adverse symptom , the majority of these were infusion related , and nephrotoxicity was reported in only 12 % of these patients . CONCLUSIONS ABCD was well-tolerated at doses up to 5 times greater then those usually tolerated with amphotericin B. Renal toxicity was markedly less than expected , and there were no other unexpected severe toxicities . Further r and omized studies are needed to further define the role of this and other liposomal products in children OBJECTIVE To compare conventional amphotericin B ( c-amp B ) and liposomal amphotericin B ( L-AMP-LRC-1-India ) in patients with systemic fungal infection in open , r and omized , comparative , laboratory blind , phase III safety and efficacy study . MATERIAL AND METHODS Formulation of liposomal amphotericin B - L-AMP-LRC-1 , containing natural phospholipids , was prepared and tested at the Department of Clinical Pharmacology , Seth GS Medical College and KEM Hospital , Mumbai , India . Patients suffering from proven systemic fungal infection , were treated with c-amp B or L-AMP-LRC-1 with 17 patients in each group . Data was compared for the safety and efficacy . RESULTS SAFETY L-AMP-LRC-1 was better tolerated than c-amp B. Out of the 695 infusions of c-amp B fever occurred on 25.04 % occasions in 68.42 % patients , while it occurred on 2.09 % occasions out of 767 infusions ( in 30.43 % patients of L-AMP-LRC-1 . Chills occurred on 16.83 % and 1.17 % occasions after c-amp B and liposomal amphotericin B respectively . Other adverse effects observed on 0.2 - 5 % of occasions were : headache , nausea , vomiting , palpitation and dizziness occurring more frequently in c-amp B group . The L-AMP-LRC-1 did not cause bronchospasm at 1 mg/kg dose in a patient who developed bronchospasm to 0.1 mg/kg dose of c-amp B. The L-AMP-LRC-1 was found to be less nephrotoxic than c-amp B and could be administered to patients who had renal problems or had undergone renal transplant . L-AMP-LRC-1 caused less hypokalemia than c-amp B. Effficacy : 17/17 patients in L-AMP-LRC-1 group and 14/17 in c-amp B group had complete response ( 100 % and 82.35 % response rate ) . The number of infusions and dose of amphotericin B and L-AMP-LRC-1 used were similar and required individualization of duration of treatment ( in cases where response to fixed duration was not observed ) . All the patients were treated with 0.5 to 1.0 mg/kg/day dose of L-AMP-LRC-1 ( except one patient required 2 mg/kg dose ) . This is markedly different from other marketed liposome and lipid formulations , which are recommended at higher ( 3 - 5 mg/kg ) doses every day . At the same time L-AMP-LRC-1 being prepared from naturally occurring lipids is expected to cost at least one-third of the marketed formulation . Thus cost of every day treatment would be very much less compared to other delivery systems . Thus L-AMP-LRC-1 will be an economical and safe treatment option available to the physicians for the treatment of systemic fungal infection BACKGROUND Empirical antifungal therapy is the st and ard of care for neutropenic patients with hematological malignancies who remain febrile despite broad-spectrum antibacterial treatment . Recent diagnostic improvements may ensure the early diagnosis of potentially invasive fungal disease . Reserving antifungals for this stage may achieve similar survival rates and reduce treatment toxicity and costs . METHODS In this multicenter , open-label , r and omized noninferiority trial , we compared an empirical antifungal strategy with a preemptive one . Empirical treatment was defined as antibacterial treatment of patients who have persistent or recurrent fever . Preemptive treatment was defined as treatment of patients who have clinical , imaging , or galactomannan-antigen-assay evidence suggesting fungal disease . First-line antifungal treatment was amphotericin B deoxycholate ( 1 mg/kg/day ) or liposomal amphotericin ( 3 mg/kg/day ) , depending on daily renal function . The primary efficacy outcome was the proportion of patients alive at 14 days after recovery from neutropenia . RESULTS The median duration of neutropenia ( neutrophil count , < 500 cells/mm3 ) for the 293 patients enrolled was 18 days ( range , 5 - 69 days ) . By intention-to-treat analysis , survival was 97.3 % with empirical treatment and 95.1 % with preemptive treatment . The lower 95 % confidence limit for the difference in mortality was -5.9 % , which was within the noninferiority margin of -8 % . Probable or proven invasive fungal infections were more common among patients who received preemptive treatment than among patients who received empirical treatment ( 13 of 143 vs. 4 of 150 ; P < .05 ) , and most infections occurred during induction therapy ( 12 of 73 patients in the preemptive treatment group vs. 3 of 78 patients in the empirical treatment group were infected during induction therapy ; P < .01 ) . Preemptive treatment did not decrease nephrotoxicity but decreased costs of antifungal therapy by 35 % . CONCLUSIONS Preemptive treatment increased the incidence of invasive fungal disease , without increasing mortality , and decreased the costs of antifungal drugs . Empirical treatment may provide better survival rates for patients receiving induction chemotherapy BACKGROUND Invasive c and idosis is increasingly prevalent in seriously ill patients . Our aim was to compare micafungin with liposomal amphotericin B for the treatment of adult patients with c and idaemia or invasive c and idosis . METHODS We did a double-blind , r and omised , multinational non-inferiority study to compare micafungin ( 100 mg/day ) with liposomal amphotericin B ( 3 mg/kg per day ) as first-line treatment of c and idaemia and invasive c and idosis . The primary endpoint was treatment success , defined as both a clinical and a mycological response at the end of treatment . Primary analyses were done on a per- protocol basis . This trial is registered with Clinical Trials.gov , number NCT00106288 . FINDINGS 264 individuals were r and omly assigned to treatment with micafungin ; 267 were r and omly assigned to receive liposomal amphotericin B. 202 individuals in the micafungin group and 190 in the liposomal amphotericin B group were included in the per- protocol analyses . Treatment success was observed for 181 ( 89.6 % ) patients treated with micafungin and 170 ( 89.5 % ) patients treated with liposomal amphotericin B. The difference in proportions , after stratification by neutropenic status at baseline , was 0.7 % ( 95 % CI -5.3 to 6.7 ) . Efficacy was independent of the C and ida spp and primary site of infection , as well as neutropenic status , APACHE II score , and whether a catheter was removed or replaced during the study . There were fewer treatment-related adverse events -- including those that were serious or led to treatment discontinuation -- with micafungin than there were with liposomal amphotericin B. INTERPRETATION Micafungin was as effective as-- and caused fewer adverse events than -- liposomal amphotericin B as first-line treatment of c and idaemia and invasive c and idosis ABSTRACT We conducted a multicenter study of the safety , tolerability , and plasma pharmacokinetics of the parenteral formulation of voriconazole in immunocompromised pediatric patients ( 2 to 11 years old ) . Single doses of 3 or 4 mg/kg of body weight were administered to six and five children , respectively . In the multiple-dose study , 28 patients received loading doses of 6 mg/kg every 12 h on day 1 , followed by 3 mg/kg every 12 h on day 2 to day 4 and 4 mg/kg every 12 h on day 4 to day 8 . St and ard population pharmacokinetic approaches and generalized additive modeling were used to construct the structural pharmacokinetic and covariate models used in this analysis . In contrast to that in adult healthy volunteers , elimination of voriconazole was linear in children following doses of 3 and 4 mg/kg every 12 h. Body weight was more influential than age in accounting for the observed variability in voriconazole pharmacokinetics . Elimination capacity correlated with the CYP2C19 genotype . Exposures were similar at 4 mg/kg every 12 h in children ( median area under the concentration-time curve ( AUC ) , 14,227 ng · h/ml ) and 3 mg/kg in adults ( median AUC , 13,855 ng · h/ml ) . Visual disturbances occurred in 5 ( 12.8 % ) of the 39 patients and were the only drug-related adverse events that occurred more than once . No withdrawals from the study were related to voriconazole . We conclude that pediatric patients have a higher capacity for elimination of voriconazole per kilogram of body weight than do adult healthy volunteers and that dosages of 4 mg/kg may be required in children to achieve exposures consistent with those in adults following dosages of 3 mg/kg A pilot exploratory study was undertaken to collect preliminary information relating to safety and overall outcome in using intravenous fluconazole ( FLUC ) for managing antibiotic resistant neutropenic fever ( ARNF ) , with the objective of assessing feasibility of performing a larger prospect i ve controlled study . Patients who were neutropenic from treatment for leukaemia or bone marrow transplantation , received either fluconazole ( FLUC ) or amphotericin B ( AB ) . Eight of 16 patients ( 50 % ) on FLUC and 21 of 25 patients ( 84 % ) on AB defervesced ; the mean time to defervescence was 11.0 + /- 10.0 days for FLUC compared to 7.7 + /- 6.3 days for AB , and a similar proportion in each treatment group defervesced within 5 days ( 50 % vs. 52 % ) , respectively . Six of 16 patients ( 37.5 % ) on FLUC and three of 25 patients ( 12 % ) on AB developed overt invasive fungal disease , including pulmonary aspergillosis ( FLUC 4 cases , AB 2 cases ) and invasive c and idiasis ( FLUC 2 cases , AB 0 cases ) . The mean time to these events was 19.5 + /- 13.4 ( FLUC ) and 9.0 + /- 3.6 ( AB ) days . The fungal related mortality rates were higher in the FLUC group : five of 16 patients ( 31 % ) vs. two of 25 patients ( 18 % ) died respectively ; the time to fungal death was 43.2 + /- 18.2 ( FLUC ) and 25.0 + /- 18.4 ( AB ) days . This tendency towards a more favourable outcome in patients on AB may have been due to absence of prior fluconazole prophylaxis in patients subsequently receiving IV FLUC . Analysis of a small subgroup of patients who had all received prior prophylaxis with clotrimazole only , indicated that a greater number of patients subsequently receiving IV FLUC died from fungal disease ( 5/16 vs.0/6 , P = 0.09 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Amphotericin B , despite its intrinsic servere toxicity , is the most commonly used empirical antifungal therapy in cancer patients with unexplained fever not responding to empirical antibacterial therapy . The aim of this study was to show whether fluconazole was as effective as , and less toxic than , amphotericin , with no effort made to compare the antifungal activity of the two drugs . A group of 112 persistently febrile ( > 38 degrees C ) and granulocytopenic ( < 1000 cells/mm3 ) cancer patients , not receiving any absorbable antifungal antibiotic for prophylaxis , with a mean age of 27 years ( range 1 - 73 years ) , undergoing chemotherapy for a variety of malignancies and with a diagnosis of unexplained fever after at least 96 h of empirical antibacterial therapy , were r and omised to receive either fluconazole ( 6 mg/kg/day up to 400 mg/day ) or amphotericin B ( 0.8 mg/kg/day ) as empirical antifungal treatment . Patients were required to have normal chest X-rays at r and omisation , no previous history of aspergillosis and negative surveillance cultures for Aspergillus . The intention-to-treat analysis showed defervescence and survival without treatment modification in 42 of 56 patients ( 75 % ) in the fluconazole group and in 37 of 56 ( 66 % ) in the amphotericin B group ( P = 0.4 ) . Duration of therapy was 6 days ( 95 % CI = 4 - 8 days ) in both groups . Death occurred in 3 patients ( 5 % ) in the fluconazole and in 2 ( 4 % ) in the amphotericin B group . No fungal death was documented in either group . Adverse events developed in 18 of 56 patients ( 32 % ) in the fluconazole group and in 46 of 56 ( 82 % ) in the amphotericin B group ( P < 0.001 ) . In the amphotericin B group , 5 patients had treatment discontinued because of toxicity , versus none in the fluconazole group , a difference which approached statistical significance ( P = 0.06 ) . This study shows that fluconazole is by far less toxic than amphotericin B and suggests that it might be as effective as amphotericin B , in pragmatical terms and for this specific indication . However , numbers are too small to allow definitive conclusions about efficacy , and the use of fluconazole for this indication remains experimental . Future studies should try to identify patients more at risk of fungal infections , with the aim of individualising antifungal approaches BACKGROUND Patients with persistent fever and neutropenia often receive empirical therapy with conventional or liposomal amphotericin B for the prevention and early treatment of invasive fungal infections . Caspofungin , a member of the new echinoc and in class of compounds , may be an effective alternative that is better tolerated than amphotericin B. METHODS In this r and omized , double-blind , multinational trial , we assessed the efficacy and safety of caspofungin as compared with liposomal amphotericin B as empirical antifungal therapy . At study entry , patients were stratified according to risk and according to whether they had previously received antifungal prophylaxis . A successful outcome was defined as the fulfillment of all components of a five-part composite end point . RESULTS Efficacy was evaluated in 1095 patients ( 556 receiving caspofungin and 539 receiving liposomal amphotericin B ) . After adjustment for strata , the overall success rates were 33.9 percent for caspofungin and 33.7 percent for liposomal amphotericin B ( 95.2 percent confidence interval for the difference , -5.6 to 6.0 percent ) , fulfilling statistical criteria for the noninferiority of caspofungin . Among patients with baseline fungal infections , a higher proportion of those treated with caspofungin had a successful outcome ( 51.9 percent vs. 25.9 percent , P=0.04 ) . The proportion of patients who survived at least seven days after therapy was greater in the caspofungin group ( 92.6 percent vs. 89.2 percent , P=0.05 ) . Premature study discontinuation occurred less often in the caspofungin group than in the amphotericin B group ( 10.3 percent vs. 14.5 percent , P=0.03 ) . The rates of breakthrough fungal infections and resolution of fever during neutropenia were similar in the two groups . Fewer patients who received caspofungin sustained a nephrotoxic effect ( 2.6 percent vs. 11.5 percent , P<0.001 ) , an infusion-related event ( 35.1 percent vs. 51.6 percent , P<0.001 ) , or a drug-related adverse event or discontinued therapy because of drug-related adverse events . CONCLUSIONS Caspofungin is as effective as and generally better tolerated than liposomal amphotericin B when given as empirical antifungal therapy in patients with persistent fever and neutropenia BACKGROUND Voriconazole has proven efficacy against invasive aspergillosis and oesophageal c and idiasis . This multicentre , r and omised , non-inferiority study compared voriconazole with a regimen of amphotericin B followed by fluconazole for the treatment of c and idaemia in non-neutropenic patients . METHODS Non-neutropenic patients with a positive blood culture for a species of c and ida and clinical evidence of infection were enrolled . Patients were r and omly assigned , in a 2:1 ratio , either voriconazole ( n=283 ) or amphotericin B followed by fluconazole ( n=139 ) . The primary efficacy analysis was based on clinical and mycological response 12 weeks after the end of treatment , assessed by an independent data - review committee unaware of treatment assignment . FINDINGS Of 422 patients r and omised , 370 were included in the modified intention-to-treat population . Voriconazole was non-inferior to amphotericin B/fluconazole in the primary efficacy analysis , with successful outcomes in 41 % of patients in both treatment groups ( 95 % CI for difference -10.6 % to 10.6 % ) . At the last evaluable assessment , outcome was successful in 162 ( 65 % ) patients assigned voriconazole and 87 ( 71 % ) assigned amphotericin B/fluconazole ( p=0.25 ) . Voriconazole cleared blood cultures as quickly as amphotericin B/fluconazole ( median time to negative blood culture , 2.0 days ) . Treatment discontinuations due to all-cause adverse events were more frequent in the voriconazole group , although most discontinuations were due to non-drug-related events and there were significantly fewer serious adverse events and cases of renal toxicity than in the amphotericin B/fluconazole group . INTERPRETATION Voriconazole was as effective as the regimen of amphotericin B followed by fluconazole in the treatment of c and idaemia in non-neutropenic patients , and with fewer toxic effects . RELEVANCE TO PRACTICE There are several options for treatment of c and idaemia in non-neutropenic patients , including amphotericin B , fluconazole , voriconazole , and echinoc and ins . Voriconazole can be given both as initial intravenous treatment and as an oral stepdown agent BACKGROUND Caspofungin is an echinoc and in agent with fungicidal activity against c and ida species . We performed a double-blind trial to compare caspofungin with amphotericin B deoxycholate for the primary treatment of invasive c and idiasis . METHODS We enrolled patients who had clinical evidence of infection and a positive culture for c and ida species from blood or another site . Patients were stratified according to the severity of disease , as indicated by the Acute Physiology and Chronic Health Evaluation ( APACHE II ) score , and the presence or absence of neutropenia and were r and omly assigned to receive either caspofungin or amphotericin B. The study was design ed to compare the efficacy of caspofungin with that of amphotericin B in patients with invasive c and idiasis and in a subgroup with c and idemia . RESULTS Of the 239 patients enrolled , 224 were included in the modified intention-to-treat analysis . Base-line characteristics , including the percentage of patients with neutropenia and the mean APACHE II score , were similar in the two treatment groups . A modified intention-to-treat analysis showed that the efficacy of caspofungin was similar to that of amphotericin B , with successful outcomes in 73.4 percent of the patients treated with caspofungin and in 61.7 percent of those treated with amphotericin B ( difference after adjustment for APACHE II score and neutropenic status , 12.7 percentage points ; 95.6 percent confidence interval , -0.7 to 26.0 ) . An analysis of patients who met prespecified criteria for evaluation showed that caspofungin was superior , with a favorable response in 80.7 percent of patients , as compared with 64.9 percent of those who received amphotericin B ( difference , 15.4 percentage points ; 95.6 percent confidence interval , 1.1 to 29.7 ) . Caspofungin was as effective as amphotericin B in patients who had c and idemia , with a favorable response in 71.7 percent and 62.8 percent of patients , respectively ( difference , 10.0 percentage points ; 95.0 percent confidence interval , -4.5 to 24.5 ) . There were significantly fewer drug-related adverse events in the caspofungin group than in the amphotericin B group . CONCLUSIONS Caspofungin is at least as effective as amphotericin B for the treatment of invasive c and idiasis and , more specifically , c and idemia BACKGROUND Treatment of invasive mold infection in immunocompromised patients remains challenging . Voriconazole has been shown to have efficacy and survival benefits over amphotericin B deoxycholate , but its utility is limited by drug interactions . Liposomal amphotericin B achieves maximum plasma levels at a dosage of 10 mg/kg per day , but clinical efficacy data for higher doses are lacking . METHODS In a double-blind trial , patients with proven or probable invasive mold infection were r and omized to receive liposomal amphotericin B at either 3 or 10 mg/kg per day for 14 days , followed by 3 mg/kg per day . The primary end point was favorable ( i.e. , complete or partial ) response at the end of study drug treatment . Survival and safety outcomes were also evaluated . RESULTS Of 201 patients with confirmed invasive mold infection , 107 received the 3-mg/kg daily dose , and 94 received the 10-mg/kg daily dose . Invasive aspergillosis accounted for 97 % of cases . Hematological malignancies were present in 93 % of patients , and 73 % of patients were neutropenic at baseline . A favorable response was achieved in 50 % and 46 % of patients in the 3- and 10-mg/kg groups , respectively ( difference , 4 % ; 95 % confidence interval , -10 % to 18 % ; P>.05 ) ; the respective survival rates at 12 weeks were 72 % and 59 % ( difference , 13 % ; 95 % confidence interval , -0.2 % to 26 % ; P>.05 ) . Significantly higher rates of nephrotoxicity and hypokalemia were seen in the high-dose group . CONCLUSIONS In highly immunocompromised patients , the effectiveness of 3 mg/kg of liposomal amphotericin B per day as first-line therapy for invasive aspergillosis is demonstrated , with a response rate of 50 % and a 12-week survival rate of 72 % . The regimen of 10 mg/kg per day demonstrated no additional benefit and higher rates of nephrotoxicity Forty-two patients with active paracoccidioidomycosis were r and omized to receive itraconazole ( 50 - 100 mg d(-1 ) ) , ketoconazole ( 200 - 400 mg d(-1 ) ) or sulfadiazine ( 100 - 150 mg kg d(-1 ) up to 6 g d(-1 ) ) for 4 - 6 months , followed by slow release sulfa until negativity of serological tests . All 14 patients in itraconazole and sulfadiazine groups and 13 in the ketoconazole group showed an adequate clinical response to the chemotherapy . One patient in the latter group showed treatment failure according to clinical and mycological criteria . The test of the hypothesis that the drugs reduced antibody levels up to ten months of treatment showed a p value equal to 0.0001 for itraconazole , 0.017 for ketoconazole and 0.0012 for sulfadiazine ; this reduction was similar for the three groups . In this first r and omized study for the treatment of paracoccidioidomycosis we could not show superiority of any one regimen over the others in the clinical and serological responses of patients with the moderately severe form of the disease OBJECTIVE . The purpose of this work was to identify differences in incidence , risk factors , microbiology , treatment , and clinical outcome of c and idemia in neonates , children , and adults that might impact on management . PATIENTS AND METHODS . Cases of c and idemia in Australia were identified prospect ively by blood culture surveillance over 3 years . Episodes of c and idemia in neonatal , pediatric , and adult age groups were analyzed and compared . RESULTS . Of 1005 incident cases , 33 occurred in neonates , 110 in children , and 862 in adults . The respective annual age-specific incidences were 4.4 , 0.9 , and 1.8 per 100 000 population . Prematurity and ICU admission were major risk factors in neonates . Hematologic malignancy and neutropenia were significantly more frequent in children than in neonates and adults . Diabetes , renal disease , hemodialysis , and recent surgery were more common in adults . C and idemia was attributed to a vascular access device in 58 % of neonates , 70 % of children , and 44 % of adults . C and ida albicans caused ∼48 % of cases in all of the age groups . C and ida parapsilosis was significantly more common in neonates and children ( 42 % and 38 % vs 15 % ) . C and ida glabrata was infrequent in neonates and children ( 9 % and 3 % vs 17 % ) . Significantly more isolates from children were susceptible to fluconazole compared with those from adults ( 95 % vs 75 % ) . Fluconazole-resistant c and idal isolates were infrequent in all of the age groups . Neonates and children were more likely to receive amphotericin B compared with adults . Adults were more likely to receive fluconazole . Survival rates at 30 days were 78 % in neonates , 90 % in children , and 70 % in adults . CONCLUSIONS . This study identifies significant differences in c and idemia in neonates , children , and adults . Neonatologists and pediatricians must consider age-specific differences when interpreting adult studies and developing treatment and prevention guidelines OBJECTIVE Fungal septicemia is a devastating disease in the neonate , especially in the low birth weight preterm infant who is especially vulnerable to disseminated fungal sepsis . The objective of this study was to compare the efficacy , safety and overall convenience of fluconazole vs. amphotericin B for the treatment of disseminated fungal sepsis in neonates . DESIGN A prospect i ve , r and omized , collaborative study conducted at two South African neonatal units . SUBJECTS Twenty-four infants with proven fungal septicemia were treated from June , 1992 , to June , 1993 . Twelve received fluconazole , 11 received amphotericin B and 1 was excluded . Assessment of hepatic , renal and hematologic functions were performed before , during and after treatment . The two groups were comparable at the time of enrollment into the study . RESULTS Infants receiving amphotericin B had significantly higher values of total and direct bilirubin and alkaline phosphatase values at the end of treatment , while the fluconazole group showed a significant increase in the platelet count . The cumulative total numbers of days receiving intravenous therapy for the administration of antifungal drugs were 57 for the fluconazole group and 162 for the amphotericin group ; no central lines were needed in the fluconazole group , whereas 3 babies given amphotericin B had central catheters for a cumulative total of 27 days . The case fatality rate was 33 % in the fluconazole group and 45 % in the amphotericin B group ; there was still proof of fungal septicemia at the time of death in 1 patient given amphotericin B and 2 given fluconazole . CONCLUSION Fluconazole showed fewer side effects than amphotericin B and was more convenient to use ABSTRACT Animal studies have shown that fungal burden correlates with survival during treatment with new antifungal therapies for histoplasmosis . The purpose of this report is to compare the clearance of fungal burden in patients with histoplasmosis treated with liposomal amphotericin B versus itraconazole . In two separate closed clinical trials that evaluated the efficacy of liposomal amphotericin B and itraconazole treatment of disseminated histoplasmosis in patients with AIDS , blood was cultured for fungus and blood and urine were tested forHistoplasma antigen . The clinical response rates were similar ; 86 % with liposomal amphotericin B ( n = 51 ) versus 85 % with itraconazole ( n = 59 ) . Of the patients with positive blood cultures at enrollment , after 2 weeks of therapy cultures were negative in over 85 % of the liposomal amphotericin B group versus 53 % of the itraconazole group ( P = 0.0008 ) . Furthermore , after 2 weeks , median antigen levels in serum fell by 1.6 U in the liposomal amphotericin B group versus 0.1 U in the itraconazole group ( P = 0.02 ) , and those in urine fell by 2.1 U in the liposomal amphotericin B group and 0.2 U in the itraconazole group ( P = 0.0005 ) . The more rapid clearance of fungemia supports the use of liposomal amphotericin B rather than itraconazole for initial treatment of moderately severe or severe histoplasmosis Abstract Since early diagnosis of even a disseminated fungal infection is difficult and treatment often ineffective in a patient with persistent granulocytopenia , we have prospect ively evaluated continued antibiotic therapy and early empiric antifungal therapy in patients with prolonged fever and granulocytopenia . Between November 1975 and December 1979 , all patients with fever ( oral temperature > 38 ° C three times per 24 hours or > 38.5 ° C once ) plus granulocytopenia ( polymorphonuclear leukocytes 3 ) , were evaluated and began an empiric antibiotic regimen consisting of Keflin ® , gentamicin and carbenicillin ( KGC ) . Of the 652 episodes of fever and granulocytopenia ( in 271 patients ) , initial evaluation failed to define an infectious etiology in 323 ( 49.5 percent ) . In 50 of the patients in whom initial evaluation did not demonstrate an infectious etiology , fever and granulocytopenia continued after seven days of therapy with KGC , without evidence for the etiology of their persistent fever . These patients were r and omized to either discontinue receiving KGC ( Group 1 ) ; continue receiving KGC ( Group 2 ) ; continue receiving KGC with the addition of empiric amphotericin B ( Group 3 ) . The duration of granulocytopenia was comparable in the three groups ( median 24 days , range 8 to 51 days ) . Clinical ly or microbiologically demonstrable infections occurred in nine of 16 patients who discontinued the KGC regimen ( Group 1 ) ( six also experienced shock , p Empiric amphotericin B therapy was also evaluated for its effectiveness in patients whose initial evaluation revealed an infectious etiology with fungal colonization throughout their alimentary tract but in whom fever and granulocytopenia remained despite at least seven days of therapy with appropriate antibiotics . In addition , the postmortem records of all patients dying between 1970 and 1979 were review ed to ascertain the cause of death and the type of antimicrobial therapy received prior to death . Only one death due to fungal invasion occurred , when therapy with amphotericin B was instituted after one week of broad-spectrum antibiotic therapy . Collectively , these data suggest that continuing antibiotic therapy reduces early bacterial infections in patients with persistent fever and granulocytopenia and that empiric antifungal therapy also appears necessary to prevent fungal superinfections and to control clinical ly undetected fungal invasion One hundred and thirty‐four adults and 204 children were r and omized in two prospect i ve , parallel comparative multicentre trials to receive either conventional amphotericin B 1 mg/kg/d ( c‐AMB ) , liposomal amphotericin B 1 mg/kg/d ( L‐AMB1 ) or liposomal amphotericin B 3 mg/kg/d ( L‐AMB3 ) . Patients were entered if they had a pyrexia of unknown origin ( PUO ) defined as temperature of 38 ° C or more , not responding to 96 h of systemic broad‐spectrum antibiotic treatment , and neutropenia ( < 0.5 × 109/l ) . The safety and toxicity of liposomal amphotericin B was compared with that of conventional amphotericin B. Efficacy of treatment was assessed , with success defined as resolution of fever for 3 consecutive days ( < 38 ° C ) without the development of any new fungal infection . Clinical and laboratory parameters were collected for safety analysis . In both the paediatric and adult population s , L‐AMB treated patients had a 2–6‐fold decrease in the incidence ( P 0.01 ) of test‐drug‐related side‐effects , compared to c‐AMB . Severe trial‐drug‐related side‐effects were seen in 1 % of L‐AMB treated patients , in contrast to 12 % of patients on c‐AMB ( P < 0.01 ) . Nephrotoxicity , in the patient subset not receiving concomitant nephrotoxic agents , defined as a doubling from the patients baseline serum creatinine level , was not observed in the L‐AMB1 arm whereas the incidence was 3 % in patients on L‐AMB3 and 23 % in those on c‐AMB ( P < 0.01 ) . Moreover , time to develop nephrotoxicity was longer in both L‐AMB arms than c‐AMB ( P < 0.01 ) . Severe hypokalaemia was observed less frequently in both L‐AMB arms ( P < 0.01 ) BACKGROUND Anidulafungin , a new echinoc and in , has potent activity against c and ida species . We compared anidulafungin with fluconazole in a r and omized , double-blind , noninferiority trial of treatment for invasive c and idiasis . METHODS Adults with invasive c and idiasis were r and omly assigned to receive either intravenous anidulafungin or intravenous fluconazole . All patients could receive oral fluconazole after 10 days of intravenous therapy . The primary efficacy analysis assessed the global response ( clinical and microbiologic ) at the end of intravenous therapy in patients who had a positive baseline culture . Efficacy was also assessed at other time points . RESULTS Eighty-nine percent of the 245 patients in the primary analysis had c and idemia only . C and ida albicans was isolated in 62 % of the 245 patients . In vitro fluconazole resistance was infrequent . Most of the patients ( 97 % ) did not have neutropenia . At the end of intravenous therapy , treatment was successful in 75.6 % of patients treated with anidulafungin , as compared with 60.2 % of those treated with fluconazole ( difference , 15.4 percentage points ; 95 % confidence interval [ CI ] , 3.9 to 27.0 ) . The results were similar for other efficacy end points . The statistical analyses failed to show a " center effect " ; when data from the site enrolling the largest number of patients were removed , success rates at the end of intravenous therapy were 73.2 % in the anidulafungin group and 61.1 % in the fluconazole group ( difference , 12.1 percentage points ; 95 % CI , -1.1 to 25.3 ) . The frequency and types of adverse events were similar in the two groups . The rate of death from all causes was 31 % in the fluconazole group and 23 % in the anidulafungin group ( P=0.13 ) . CONCLUSIONS Anidulafungin was shown to be noninferior to fluconazole in the treatment of invasive c and idiasis . ( Clinical Trials.gov number , NCT00056368 [ Clinical Trials.gov ] ) BACKGROUND Sensitivity analyses were incorporated in a Phase III study of caspofungin vs. liposomal amphotericin B as empirical antifungal therapy for febrile neutropenic patients to determine the impact of varying definitions of fever resolution on response rates . METHODS The primary analysis used a 5-part composite endpoint : resolution of any baseline invasive fungal infection , no breakthrough invasive fungal infection , survival , no premature discontinuation of study drug , and fever resolution for 48 h during the period of neutropenia . Pre-specified analyses used 3 other definitions for fever resolution : afebrile for 24 h during the period of neutropenia , afebrile at 7 days post therapy , and eliminating fever resolution altogether from the composite endpoint . Patients were stratified on entry by use of antifungal prophylaxis and risk of infection . Allogeneic hematopoietic stem cell transplants or relapsed acute leukemia defined high-risk patients . RESULTS In the primary analysis , 41 % of patients in each treatment group met the fever-resolution criteria . Low-risk patients had shorter duration s of neutropenia but failed fever-resolution criteria more often than high-risk patients . In each exploratory analysis , response rates increased in both treatment groups compared to the primary analysis , particularly in low-risk patients . CONCLUSIONS Response rates for the primary composite endpoint for both treatment groups in this study were driven by low rates of fever resolution . Requiring fever resolution during neutropenia in a composite endpoint can mask more clinical ly relevant outcomes This is the first completed prospect i ve r and omized clinical efficacy trial of antifungals in the treatment of invasive aspergillosis ( IA ) and the first to compare the clinical efficacy of two dosages of liposomal amphotericin B ( L-AmB ) for IA in neutropenic patients with cancer or those undergoing bone marrow transplantation . Eighty-seven of 120 patients were eligible and evaluable . Clinical responses were documented for 26 ( 64 % ) of 41 patients receiving 1 mg/(kg.d ) ( L-AmB-1 ) and 22 ( 48 % ) of 46 receiving 4 mg/(kg.d ) ( L-AmB-4 ) . Radiologic response rates were similar : 24 ( 58 % ) of the L-AmB-1 recipients and 24(52 % ) of the L-AmB-4 recipients . The six-month survival rates were 43 % ( L-AmB-1 ) and 37 % ( L-AmB-4 ) . These differences were not significant . The numbers of deaths directly due to IA at 6 months were similar : 9 ( 22 % ) of 41 L-AmB-1 recipients and 9 ( 20 % ) of 46 L-AmB-4 recipients . No other variable independently influenced survival , apart from central nervous system IA . L-AmB is effective in treating approximately 50%-60 % of patients who have IA . A 1-mg/(kg.d ) dosage is as effective as a 4-mg/(kg.d ) dosage , and no advantages to use of the higher , more expensive , dosage has been observed BACKGROUND Mycograb ( NeuTec Pharma ) is a human recombinant monoclonal antibody against heat shock protein 90 that , in laboratory studies , was revealed to have synergy with amphotericin B against a broad spectrum of C and ida species . METHODS A double-blind , r and omized study was conducted to determine whether lipid-associated amphotericin B plus Mycograb was superior to amphotericin B plus placebo in patients with culture-confirmed invasive c and idiasis . Patients received a lipid-associated formulation of amphotericin B plus a 5-day course of Mycograb or placebo , having been stratified on the basis of C and ida species ( C and ida albicans vs. non-albicans species of C and ida ) . Inclusion criteria included clinical evidence of active infection at trial entry plus growth of C and ida species on culture of a specimen from a clinical ly significant site within 3 days after initiation of study treatment . The primary efficacy variable was overall response to treatment ( clinical and mycological resolution ) by day 10 . RESULTS Of the 139 patients enrolled from Europe and the United States , 117 were included in the modified intention-to-treat population . A complete overall response by day 10 was obtained for 29 ( 48 % ) of 61 patients in the amphotericin B group , compared with 47 ( 84 % ) of 56 patients in the Mycograb combination therapy group ( odds ratio [ OR ] , 5.8 ; 95 % confidence interval [ CI ] , 2.41 - 13.79 ; P<.001 ) . The following efficacy criteria were also met : clinical response ( 52 % vs. 86 % ; OR , 5.4 ; 95 % CI , 2.21 - 13.39 ; P<.001 ) , mycological response ( 54 % vs. 89 % ; OR , 7.1 ; 95 % CI , 2.64 - 18.94 ; P<.001 ) , C and ida-attributable mortality ( 18 % vs. 4 % ; OR , 0.2 ; 95 % CI , 0.04 - 0.80 ; P = .025 ) , and rate of culture-confirmed clearance of the infection ( hazard ratio , 2.3 ; 95 % CI , 1.4 - 3.8 ; P = .001 ) . Mycograb was well tolerated . CONCLUSIONS Mycograb plus lipid-associated amphotericin B produced significant clinical and culture-confirmed improvement in outcome for patients with invasive c and idiasis |
1,341 | 25,978,975 | We expect that overall survival data will be available in a future up date of this review .Disease-free survival and rate of local and regional recurrence favoured SLNB in both groups of participants with intermediate-thickness and thick melanomas but short-term surgical morbidity was higher in the SLNB group , especially with regard to complications in the nodal basin .
Currently this evidence is not sufficient to document a benefit of SLNB when compared to observation in individuals with primary localised cutaneous melanoma | BACKGROUND Melanoma is the leading cause of skin cancer-associated mortality .
The vast majority of newly diagnosed melanomas are confined to the primary cutaneous site .
Surgery represents the mainstay of melanoma treatment .
Treatment strategies include wide excision of the primary tumour and sentinel lymph node biopsy ( SLNB ) to assess the status of the regional nodal basin(s ) .
SLNB has become an important component of initial melanoma management providing accurate disease staging .
OBJECTIVES To assess the effects and safety of SLNB followed by completion lymph node dissection ( CLND ) for the treatment of localised primary cutaneous melanoma . | BACKGROUND We evaluated the contribution of sentinel-node biopsy to outcomes in patients with newly diagnosed melanoma . METHODS Patients with a primary cutaneous melanoma were r and omly assigned to wide excision and postoperative observation of regional lymph nodes with lymphadenectomy if nodal relapse occurred , or to wide excision and sentinel-node biopsy with immediate lymphadenectomy if nodal micrometastases were detected on biopsy . RESULTS Among 1269 patients with an intermediate-thickness primary melanoma , the mean ( + /-SE ) estimated 5-year disease-free survival rate for the population was 78.3+/-1.6 % in the biopsy group and 73.1+/-2.1 % in the observation group ( hazard ratio for recurrence[corrected ] , 0.74 ; 95 % confidence interval [ CI ] , 0.59 to 0.93 ; P=0.009 ) . Five-year melanoma-specific survival rates were similar in the two groups ( 87.1+/-1.3 % and 86.6+/-1.6 % , respectively ) . In the biopsy group , the presence of metastases in the sentinel node was the most important prognostic factor ; the 5-year survival rate was 72.3+/-4.6 % among patients with tumor-positive sentinel nodes and 90.2+/-1.3 % among those with tumor-negative sentinel nodes ( hazard ratio for death , 2.48 ; 95 % CI , 1.54 to 3.98 ; P<0.001 ) . The incidence of sentinel-node micrometastases was 16.0 % ( 122 of 764 patients ) , and the rate of nodal relapse in the observation group was 15.6 % ( 78 of 500 patients ) . The corresponding mean number of tumor-involved nodes was 1.4 in the biopsy group and 3.3 in the observation group ( P<0.001 ) , indicating disease progression during observation . Among patients with nodal metastases , the 5-year survival rate was higher among those who underwent immediate lymphadenectomy than among those in whom lymphadenectomy was delayed ( 72.3+/-4.6 % vs. 52.4+/-5.9 % ; hazard ratio for death , 0.51 ; 95 % CI , 0.32 to 0.81 ; P=0.004 ) . CONCLUSIONS The staging of intermediate-thickness ( 1.2 to 3.5 mm ) primary melanomas according to the results of sentinel-node biopsy provides important prognostic information and identifies patients with nodal metastases whose survival can be prolonged by immediate lymphadenectomy . ( Clinical Trials.gov number , NCT00275496 [ Clinical Trials.gov ] . ) PURPOSE Low-dose ( LD ) interferon ( IFN ) alfa ( LDI ) has demonstrated a consistent disease-free survival benefit for patients with clinical ly lymph node-negative melanoma in clinical trials . However , the optimal duration of treatment is still under discussion , and no previous trial has evaluated this question specifically . A prolongation of LDI from 18 months to 60 months might be of clinical benefit for patients with intermediate or high-risk melanoma . PATIENTS AND METHODS Eight hundred fifty patients with resected cutaneous melanoma of at least 1.5 mm tumor thickness were included in this prospect i ve r and omized , multicenter trial in Germany and Austria . Patients had to be clinical ly lymph node-negative , and sentinel node biopsy ( SLNB ) was performed in a majority of cases . They were r and omly assigned to receive 3 MU IFNalpha2a three times a week subcutaneously for either 18 months ( arm A ) or 60 months ( arm B ) . Results Of 850 r and omly assigned patients , 840 were eligible for evaluation after a median follow-up of 4.3 years . Tumor thickness and other relevant prognostic factors were well balanced between both groups . SLNB was performed in 635 patients ( 75.6 % ) , with a positivity rate of 18.0 % in arm A and 17.5 % in arm B. Neither relapse-free survival ( arm A , 75.6 % v arm B , 72.6 % ; P = .72 ; hazard ratio , 1.05 ; 95 % CI , 0.80 to 1.39 ) nor distant-metastasis-free survival ( 81.9 % v 79.7 % ; P = .56 ; HR , 1.10 ; 95 % CI , 0.80 to 1.52 ) or overall survival ( 85.9 % v 84.9 % ; P = .86 ; HR , 1.03 ; 95 % CI , 0.71 to 1.50 ) showed significant differences . CONCLUSION A prolongation of conventional LDI therapy from 18 to 60 months showed no clinical benefit in patients with intermediate and high-risk primary melanoma The propensity score is the probability of treatment assignment conditional on observed baseline characteristics . The propensity score allows one to design and analyze an observational ( nonr and omized ) study so that it mimics some of the particular characteristics of a r and omized controlled trial . In particular , the propensity score is a balancing score : conditional on the propensity score , the distribution of observed baseline covariates will be similar between treated and untreated subjects . I describe 4 different propensity score methods : matching on the propensity score , stratification on the propensity score , inverse probability of treatment weighting using the propensity score , and covariate adjustment using the propensity score . I describe balance diagnostics for examining whether the propensity score model has been adequately specified . Furthermore , I discuss differences between regression-based methods and propensity score-based methods for the analysis of observational data . I describe different causal average treatment effects and their relationship with propensity score analyses Objective : The objective of this study was to evaluate , in an international multicenter phase III trial , the accuracy , use , and morbidity of intraoperative lymphatic mapping and sentinel node biopsy ( LM/SNB ) for staging the regional nodal basin of patients with early-stage melanoma . Summary Background Data : Since our introduction of LM/SNB in 1990 , this technique has been widely adopted and has become part of the American Joint Committee on Cancer ( AJCC ) staging system . Eleven years ago , the authors began the international Multicenter Selective Lymphadenectomy Trial ( MSLT-I ) to compare 2 treatment approaches : wide excision ( WE ) plus LM/SNB with immediate complete lymphadenectomy ( CLND ) for sentinel node ( SN ) metastases , and WE plus postoperative observation with CLND delayed until the subsequent development of clinical ly evident nodal metastases . Methods : After each center achieved 85 % accuracy of SN identification during a 30-case learning phase , patients with primary cutaneous melanoma ( ≥1 mm with Clark level ≥III , or any thickness with Clark level ≥IV ) were r and omly assigned in a 4:6 ratio to WE plus observation ( WEO ) with delayed CLND for nodal recurrence , or to WE plus LM/SNB with immediate CLND for SN metastasis . The accuracy of LM/SNB was determined by comparing the rates of SN identification and the incidence of SN metastases in the LM/SNB group versus the subsequent development of nodal metastases in the regional nodal basin of those patients with tumor-negative SNs . Early morbidity of LM/SNB was evaluated by comparing complication rates between the 2 treatment groups . Trial accrual was completed on March 31 , 2002 , after enrollment of 2001 patients . Results : Initial SN identification rate was 95.3 % overall : 99.3 % for the groin , 95.3 % for the axilla , and 84.5 % for the neck basins . The rate of false-negative LM/SNB during the trial phase , as measured by nodal recurrence in a tumor-negative dissected SN basin , decreased with increasing case volume at each center : 10.3 % for the first 25 cases versus 5.2 % after 25 cases . There were no operative mortalities . The low ( 10.1 % ) complication rate after LM/SNB increased to 37.2 % with the addition of CLND ; CLND also increased the severity of complications . Conclusions : LM/SNB is a safe , low-morbidity procedure for staging the regional nodal basin in early melanoma . Even after a 30-case learning phase and 25 additional LM/SNB cases , the accuracy of LM/SNB continues to increase with a center 's experience . LM/SNB should become st and ard care for staging the regional lymph nodes of patients with primary cutaneous melanoma Background In the United Kingdom ( UK ) , there is an extensive market for the class ' A ' drug heroin . Many heroin users spend time in prison . People addicted to heroin often require prescribed medication when attempting to cease their drug use . The most commonly used detoxification agents in UK prisons are buprenorphine , dihydrocodeine and methadone . However , national guidelines do not state a detoxification drug of choice . Indeed , there is a paucity of research evaluating the most effective treatment for opiate detoxification in prisons . This study seeks to address the paucity by evaluating routinely used interventions amongst drug using prisoners within UK prisons . Methods / Design The Leeds Evaluation of Efficacy of Detoxification Study ( LEEDS ) Prisons Pilot Study will use r and omised controlled trial methodology to compare the open use of buprenorphine and dihydrocodeine for opiate detoxification , given in the context of routine care , within HMP Leeds . Prisoners who are eligible and give informed consent will be entered into the trial . The primary outcome measure will be abstinence status at five days post detoxification , as determined by a urine test . Secondary outcomes during the detoxification and then at one , three and six months post detoxification will be recorded 9603 Background : Emotional state has been linked to cancer survival , but its influence on the outcome of early melanoma is unclear . The Multicenter Selective Lymphadenectomy Trial ( MSLT-I ) r and omized patients with clinical ly localized cutaneous melanoma to wide local excision ( WEX ) plus observation or to WEX plus sentinel lymph node biopsy ( SNB ) . Clinical endpoints included disease-specific and disease-free survival . A sub study of this phase III trial evaluated the impact of mood state on survival , and the impact of recurrence on mood state . METHODS Patients were asked to complete a 65- question form within 6 months of enrollment ( baseline ) and every 12 months thereafter . This question naire measured 6 identifiable mood states ( vigor-activity , tension-anxiety , depression , anger-hostility , fatigue-inertia , confusion-bewilderment ) of the Profile of Mood States ( POMS ) , a vali date d mood scale for assessing responses to therapy . Self-reported data from the question naires were linked to demographic and clinical variables . RESULTS Of 2,001 patients accrued to MSLT-I , 1,620 completed the question naire at baseline . The baseline distribution of POMS variables was similar in the two treatment arms ( data not shown ) . Patients with more vigor at baseline had a significantly longer disease-free and overall survival ( Table ) , even after adjusting for age , tumor thickness , site , and ulceration status ( p < 0.001 ) . Among 136 patients who completed a question naire within 6 months after recurrence , comparison of baseline and post-recurrence responses revealed significant changes in mood state : tension , fatigue and confusion increased , whereas vigor decreased ( p = 0.0004 , 0.0171 , 0.0089 , and 0.0028 , respectively ) . CONCLUSIONS Vigor , a measure of energy and optimism , is directly correlated with disease-free and overall survival in early melanoma . The negative impact of recurrence on mood state suggests that SNB as a tool for preventing recurrence might also improve mood state and psychological well-being . Supported by NIH CA29605 . [ Table : see text ] No significant financial relationships to disclose BACKGROUND Sentinel-node biopsy , a minimally invasive procedure for regional melanoma staging , was evaluated in a phase 3 trial . METHODS We evaluated outcomes in 2001 patients with primary cutaneous melanomas r and omly assigned to undergo wide excision and nodal observation , with lymphadenectomy for nodal relapse ( observation group ) , or wide excision and sentinel-node biopsy , with immediate lymphadenectomy for nodal metastases detected on biopsy ( biopsy group ) . Results No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population ( 20.8 % with and 79.2 % without nodal metastases ) . Mean ( ± SE ) 10-year disease-free survival rates were significantly improved in the biopsy group , as compared with the observation group , among patients with intermediate-thickness melanomas , defined as 1.20 to 3.50 mm ( 71.3 ± 1.8 % vs. 64.7 ± 2.3 % ; hazard ratio for recurrence or metastasis , 0.76 ; P=0.01 ) , and those with thick melanomas , defined as > 3.50 mm ( 50.7 ± 4.0 % vs. 40.5 ± 4.7 % ; hazard ratio , 0.70 ; P=0.03 ) . Among patients with intermediate-thickness melanomas , the 10-year melanoma-specific survival rate was 62.1 ± 4.8 % among those with metastasis versus 85.1 ± 1.5 % for those without metastasis ( hazard ratio for death from melanoma , 3.09 ; P<0.001 ) ; among patients with thick melanomas , the respective rates were 48.0 ± 7.0 % and 64.6 ± 4.9 % ( hazard ratio , 1.75 ; P=0.03 ) . Biopsy-based management improved the 10-year rate of distant disease-free survival ( hazard ratio for distant metastasis , 0.62 ; P=0.02 ) and the 10-year rate of melanoma-specific survival ( hazard ratio for death from melanoma , 0.56 ; P=0.006 ) for patients with intermediate-thickness melanomas and nodal metastases . Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group , and a significant treatment benefit persisted . CONCLUSIONS Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy . Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease-free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas . ( Funded by the National Cancer Institute , National Institutes of Health , and the Australia and New Zeal and Melanoma Trials Group ; Clinical Trials.gov number , NCT00275496 . ) Background : Age of patients with melanoma varies directly with mortality and inversely with the presence of sentinel lymph node ( SLN ) metastasis . To gain further insight into this apparent paradox , we analyzed the relationship between age and other major prognostic factors . Methods : The Sunbelt Melanoma Trial is a prospect i ve , r and omized study with 79 institutions involving SLN biopsy for melanoma . Eligible patients were 18 to 70 years old with melanoma of ≥1.0-mm Breslow thickness and clinical ly N0 regional lymph nodes . SLNs were evaluated by serial histological sections and immunohistochemistry for S-100 protein . Results : A total of 3076 patients were enrolled in the study , with a median follow-up of 19 months . Five age groups were examined : 18 to 30 , 31 to 40 , 41 to 50 , 51 to 60 , and 61 to 70 years . Trends between age and several key prognostic factors was identified : as age group increased , so did Breslow thickness ( analysis of variance ; P < .001 ) , the incidence of ulceration and regression , and the proportion of male patients ( each variable : χ2 , P < .001 ) . The incidence of SLN metastasis , however , declined with increasing age ( χ2 ; P < .001 ) . Conclusions : As age increases , so does Breslow thickness , the incidence of ulceration and regression , and the proportion of male patients —all poor prognostic factors . However , the frequency of SLN metastasis declines with increasing age . It is not known whether this represents a decreased sensitivity ( higher false-negative rate ) of the SLN procedure in older patients or a different biological behavior ( hematogenous spread ) of melanomas in older patients Background Complete lymph node dissection , the current st and ard treatment for nodal metastasis in melanoma , carries the risk of significant morbidity . Clinical ly apparent nodal tumor is likely to impact both preoperative lymphatic function and extent of soft tissue dissection required to clear the basin . We hypothesized that early dissection would be associated with less morbidity than delayed dissection at the time of clinical recurrence . Material s and Methods The Multicenter Selective Lymphadenectomy Trial I r and omized patients to wide excision of a primary melanoma with or without sentinel lymph node biopsy . Immediate completion lymph node dissection ( early CLND ) was performed when indicated in the SLN arm , while therapeutic dissection ( delayed CLND ) was performed at the time of clinical recurrence in the wide excision-alone arm . Acute and chronic morbidities were prospect ively monitored . Results Early CLND was performed in 225 patients , and in the wide excision-alone arm 132 have undergone delayed CLND . The 2 groups were similar for primary tumor features , body mass index , basin location , and demographics except age , which were higher for delayed CLND . The number of nodes evaluated and the number of positive nodes was greater for delayed CLND . There was no significant difference in acute morbidity , but lymphedema was significantly higher in the delayed CLND group ( 20.4 % vs. 12.4 % , P = .04 ) . Length of inpatient hospitalization was also longer for delayed CLND . Conclusion Immediate nodal treatment provides critical prognostic information and a likely therapeutic effect for those patients with nodal involvement . These data show that early CLND is also less likely to result in lymphedema Background Completion lymph node dissection ( CLND ) is the st and ard procedure for patients with positive sentinel lymph nodes ( SLN ) . With extensive pathological workup , increased numbers of small metastatic deposits are detected in SLN . This study evaluated the prognostic significance of SLN metastatic deposits ≤ 0.2 mm in patients treated in a referral cancer center in Brazil . Methods Patients with stage I/II melanoma , consecutively su bmi tted to a SLN procedure by the same surgeon from 2000 to 2006 , were evaluated . All positive SLN and r and omly selected negative cases were review ed by two pathologists . Different prognostic factors and SLN tumor burden were recorded . Additional positive non-SLN after CLND , and disease outcome were evaluated . Results Of 381 patients who underwent SLN biopsy , 103 ( 27 % ) were positive . The mean/median Breslow tumor thickness in the overall group was 3.4/2.0 mm and in the SLN positive patients was 5.72/4.0 mm . Among these patients , 48 ( 47 % ) had metastatic deposits > 2 mm ( macrometastasis ) , 49 ( 47 % ) had metastatic deposits ≤2 mm but > 0.2 mm ( micrometastasis ) , and 6 ( 6 % ) had metastatic deposits ≤0.2 mm ( su bmi crometastasis ) . Additional positive non-SLN were detected in 29 % of patients with macrometastasis , in 25 % of patients with micrometastasis , and in 0 % of patients with su bmi crometastases . At median follow-up of 35 months , the estimated 3-year overall survival was 92 % for negative SLN , 64 % for micrometastases , 53 % for macrometastases , and 100 % for su bmi crometastases ( P < 0.001 ) . Conclusion In the present study , patients with SLN metastatic deposits ≤0.2 mm had no additional positive non-SLNs , and no recurrences or deaths were recorded , suggesting that their prognosis is equivalent to that of patients with negative SLN The technique of lymphatic mapping and sentinel node biopsy ( SNB ) for melanoma was reported in 1990 by Dr Donald Morton , Dr Alistair Cochran and their colleagues from the John Wayne Cancer Institute in Santa Monica.1 At that time , elective complete lymph node dissection ( CLND ) of the regional nodes was the st and ard treatment recommendation for patients with intermediate thickness melanomas at many melanoma treatment centres . However , only approximately 20 % of patients who had a CLND were found to have metastatic disease in any of the lymph nodes that were removed . This implied that 80 % of these patients were being subjected to a procedure that was probably unnecessary , as well as having the potential to produce substantial short-term and long-term morbidity . Thus , one obvious attraction of the minimally invasive SNB technique was that it would spare many patients from major surgery ( i.e. CLND ) that was unlikely to be of benefit to them . Since 1990 , the validity of the sentinel node ( SN ) concept has been confirmed,2–4 and it has been shown that SN status predicts outcome in patients with melanoma more reliably than any other parameter.5 The value of the SNB technique , not only as a less invasive and less morbid alternative to CLND , but also as a valuable staging procedure and thus a guide to management , was quickly appreciated and it soon became a routine procedure in most large melanoma treatment centres worldwide . However , we live in an era of evidence -based medicine , in which it is expected that the safety , efficacy and cost-effectiveness of every new drug and medical procedure will be tested in appropriately design ed clinical trials . Accordingly , a protocol for an international phase III study to evaluate SNB was developed by Dr Donald Morton . With National Institutes of Health funding , the study commenced patient accrual in 1994 . This r and omized trial , the first Multicenter Selective Lymphadenectomy Trial ( MSLT-I ) , completed accrual of 2001 patients from 18 melanoma treatment centres in North America , Europe and Australia in March 2002 . Based on the number of events that have occurred to date in the patients who were enrolled in MSLT-I , it is likely that final results of the trial will not be available for several more years . Nevertheless , after review of the data from a planned third interim analysis of the study , undertaken in October 2004 , the independent trial Data Safety Monitoring Board ( DSMB ) recommended that this information be made generally available . The DSMB did this because its members , all highly respected physicians , statisticians and scientists , considered that it was important for treating clinicians and their patients to be made aware of the results because of their far-reaching implication s. Most patients enrolled in MSLT-I had primary melanomas ‡1.0 mm in Breslow thickness ( primary aim group , 1.2–3.5 mm ) , and they were r and omized to be treated either by wide excision ( WE ) only or by WE plus SNB , with immediate CLND if metastatic disease was found in a SN.6,7 After a median follow-up period of 59.5 months , the interim results of MSLT-I did not show a statistically significant improvement in overall survival for the patients in the SNB arm of the study . However , there was an improvement in disease-free survival ( DFS ) for this patient group ( P = 0.008 ) . There was also a significant difference in survival outcome for those patients found to have disease in their regional nodes depending on whether they had an immediate CLND after regional node positivity was diagnosed by SNB or whether they had a WE only initially , then a CLND when disease in their regional nodes became clinical ly apparent ( 5-year survival 71.2 vs 53.4 % , respectively ; P = 0.004 ) . Also of importance was the finding that patients who had an immediate CLND had a mean number of 1.4 involved nodes , whereas those who had a CLND for clinical ly detected metastatic disease had a mean number of 3.6 involved nodes . It is noteworthy that the percentage of patients in the primary aim group who were found to have a positive SN ( 15.9 % ) was identical to the percentage of patients in the WEonly group who later developed clinical ly detectable metastatic disease in a regional node field ( 15.9 % ) . In a consideration of the personal view of SNB ‘ post-MSLT-I ’ expressed by Mr Meirion Thomas in this issue of the Journal,8 the facts outlined above must be borne in mind . Also , because the interim results of MSLT-I have not yet been published in a peer review ed journal , it must be assumed that his arguments are based on abstract s and presentations made to the American Society of Clinical Oncology in Florida in May 2005 and to the 6th World Congress on Melanoma in Vancouver in September 2005 , as are the interim MSLT-I data presented above . Thus , it may well be that some of the matters discussed will be clarified in the published record of the interim trial analysis . Robust discussion of controversial subjects in medicine , as in other disciplines , is to be encouraged , but many questions can be answered only by conducting r and omized controlled trials . An example was the cl aim that carrying out a SNB procedure in patients with melanoma produced a massive increase in the rate of in-transit metastasis (ITM).9 This cl aim , considered in detail elsewhere,10,11 was based primarily on the results of one nonr and omized , retrospective single-centre study .12 Since that time , the results of two large retrospective studies have been reported,13,14 both indicating that the incidence of ITM in patients with melanoma is almost certainly determined by tumour biology and not by the surgical procedure that is carried out . However , what was ultimately required , of course , was evidence from a prospect i ve r and omized trial specifically design ed to compare outcomes for patients treated by WE only and for those treated by WE plus SNB . Such a direct comparison was made in MSLT-I , and based on the observation that in the third interim analysis the in-transit/local recurrence rates in the two patient groups were virtually identical ( 9 and 8 % , respectively , after 5 years ; P = 0.35 ) , it can now be stated with great confidence that the incidence of ITM is not increased by carrying out a SNB procedure . ANZ J. Surg . 2006 ; 76 : 100–103 doi : 10.1111/j.1445 - This article studies a semiparametric accelerated failure time mixture model for estimation of a biological treatment effect on a latent subgroup of interest with a time-to-event outcome in r and omized clinical trials . Latency is induced because membership is observable in one arm of the trial and unidentified in the other . This method is useful in r and omized clinical trials with all-or-none noncompliance when patients in the control arm have no access to active treatment and in , for example , oncology trials when a biopsy used to identify the latent subgroup is performed only on subjects r and omized to active treatment . We derive a computational method to estimate model parameters by iterating between an expectation step and a weighted Buckley-James optimization step . The bootstrap method is used for variance estimation , and the performance of our method is corroborated in simulation . We illustrate our method through an analysis of a multicenter selective lymphadenectomy trial for melanoma BACKGROUND Breslow thickness , ulceration , and sentinel lymph node ( SLN ) status are well established as the most important prognostic factors for patients with cutaneous melanoma . Anatomic location of the primary tumor is generally considered to play a minor role in determining prognosis compared with these other factors . This analysis was performed to better define the influence of anatomic location of the primary melanoma on prognosis . METHODS In this post hoc analysis of a prospect i ve r and omized trial that included patients ages 18 to 70 years with melanomas 1 mm or greater in Breslow thickness , all patients underwent SLN biopsy and completion lymphadenectomy if tumor-positive SLN were found . Kaplan-Meier survival analysis and univariate and multivariate analyses were performed to evaluate factors predictive of disease-free survival ( DFS ) , local and in-transit recurrence-free survival ( LITRFS ) , and overall survival ( OS ) . RESULTS A total of 2,500 patients were included in this analysis with a median follow-up period of 68 months . Anatomic locations included head , neck , trunk , upper extremity , and lower extremity . Age , Breslow thickness , and percentage of patients with a positive SLN were significantly different by anatomic location on univariate analysis , as were positive SLN status , presence of regression , sex , and histologic subtype ( P < .0001 ) . On multivariate analysis , anatomic location was an independent predictor of SLN status ( P < .0001 ) , DFS ( P = .045 ) , LITRFS ( P = .023 ) , and OS ( P < .0001 ) . By Kaplan-Meier analysis , anatomic location was associated significantly with DFS , LITRFS , and OS . CONCLUSIONS Anatomic location of the primary melanoma is an important independent predictor of SLN status and prognosis . Patients with primary melanomas of the head/neck and trunk have a worse prognosis than primary melanomas of other anatomic locations OBJECTIVE To quantify the impact of excision margins on disease-specific survival of patients with primary cutaneous melanoma . BACKGROUND Current guidelines recommend narrow margins for the treatment of primary melanoma , although available evidence on this subject is not unequivocal and not always appropriately analyzed . METHODS A systematic review of r and omized controlled trials ( RCT ) addressing the issue of wide versus narrow excision margins was performed . Meta- analysis methods for time-to-event data were used to extract hazard ratios(HR ) and their 95 % confidence intervals ( CI ) from eligible studies , and ultimately to estimate the summary effect of excision margins on patients ' survival . RESULTS The 5 eligible RCT enrolled a total of 3295 patients who were allocated to wide ( 3 - 5 cm ) or narrow ( 1 - 2 cm ) excision of their primary tumor . The data of locoregional disease-free ( LDFS ) , disease-free (DFS),disease-specific ( DSS ) , and overall ( OS ) survival were available for 3 , 5 , 3 , and 5 RCT , respectively . The meta- analysis suggested that narrow margins might be associated with an increased risk of both locoregional disease recurrence ( HR : 1.30 , CI : 1.07 - 1.57 ; P = 0.01 ) and death by disease ( HR : 1.28 , CI:1.07 - 1.53 , P = 0.01 ) . As regards DFS , the borderline disadvantage ( HR:1.13 , CI : 0.995 - 1.28 ; P = 0.06 ) becomes significant when considering RCT that enrolled patients with thicker melanoma ( HR : 1.19 , CI : 1.02 - 1.39 , P = 0.03 ) . When death by any cause ( OS ) was analyzed , no risk difference was found . CONCLUSIONS The lack of DSS data from all the available RCT does not allow to draw definitive conclusions . However , current evidence appears sufficient to question the common belief that narrow excision margins are as safe as wide margins in the management of primary melanoma , that calls for further investigation in this field |
1,342 | 19,589,478 | In the controlled studies , there was no heterogeneity for any outcome ; however , in the single-arm studies , there was a significant heterogeneity for the outcomes of OS , CHR , renal response , and partial hematologic response .
Our findings indicate that AHCT does not appear to be superior to CC in improving OS in patients with AL amyloidosis . | Significant uncertainty exists regarding the efficacy of high-dose chemotherapy and autologous hematopoietic cell transplantation ( AHCT ) for the treatment of patients with primary systemic ( AL ) amyloidosis . | Summary : A prospect i ve r and omized trial was conducted to study the timing of high-dose intravenous melphalan and autologous stem cell transplantation ( HDM/SCT ) in AL amyloidosis . In all , 100 newly diagnosed patients were r and omized to receive HDM/SCT , either as initial therapy ( Arm-1 ) or following two cycles of oral melphalan and prednisone ( Arm-2 ) . The objectives of the trial were to compare survival and hematologic and clinical responses . With a median follow-up of 45 months ( range 24–70 ) , the overall survival was not significantly different between the two treatment arms ( P=0.39 ) . The hematologic response and organ system improvements after treatment did not differ between the two groups . Fewer patients received HDM/SCT in Arm-2 because of disease progression during the oral chemotherapy phase of the study , rendering them ineligible for subsequent high-dose therapy . This affected patients with cardiac involvement particularly , and led to a trend for an early survival disadvantage in Arm-2 . Hence , newly diagnosed patients with AL amyloidosis eligible for HDM/SCT did not benefit from initial treatment with oral melphalan and prednisone , and there was a survival disadvantage for patients with cardiac involvement if HDM/SCT was delayed by initial oral chemotherapy One hundred sixty-eight patients with primary systemic amyloidosis ( AL ) were identified . Median survival after diagnosis was 12 months and ranged from 4 months for patients presenting with congestive heart failure to 50 months for those presenting with peripheral neuropathy only . Utilizing the proportional-hazards model in a stepwise multivariate fashion to evaluate the simultaneous influence of putative risk factors as of diagnosis revealed that congestive heart failure , urine light chain , hepatomegaly , and multiple myeloma were the major factors adversely affecting survival during the first year after diagnosis . Serum creatinine , multiple myeloma , orthostatic hypotension , and monoclonal serum protein were the most important variables adversely affecting survival for patients surviving 1 year . These models were used to categorize patients according to the variables in the models into low- , moderate- , and high-risk groups for the first year after diagnosis and separately for subsequent years . The influence of these variables on survival is important in stratification of patients r and omized to prospect i ve clinical trials High‐dose melphalan ( MEL ) with autologous stem cell transplant ( SCT ) is an effective therapy for systemic AL amyloidosis ( AL ) , but treatment‐related mortality ( TRM ) has historically been high . We performed a phase II trial of risk‐adapted SCT followed by adjuvant dexamethasone ( dex ) and thalidomide ( thal ) in an attempt to reduce TRM and improve response rates . Patients ( n = 45 ) with newly diagnosed AL involving ≤2 organ systems were assigned to MEL 100 , 140 , or 200 mg/m2 with SCT , based on age , renal function and cardiac involvement . Patients with persistent clonal plasma cell disease 3 months post‐SCT received 9 months of adjuvant thal/dex ( or dex if there was a history of deep vein thrombosis or neuropathy ) . Organ involvement was kidney ( 67 % ) , heart ( 24 % ) , liver/GI ( 22 % ) and peripheral nervous system ( 18 % ) , with 31 % having two organs involved . TRM was 4·4 % . Thirty‐one patients began adjuvant therapy , with 16 ( 52 % ) completing 9 months of treatment and 13 ( 42 % ) achieving an improvement in haematological response . By intention‐to‐treat , overall haematological response rate was 71 % ( 36 % complete response ) , with 44 % having organ responses . With a median follow‐up of 31 months , 2‐year survival was 84 % ( 95 % confidence interval : 73 % , 94 % ) . Risk‐adapted SCT with adjuvant thal/dex is feasible and results in low TRM and high haematological and organ response rates in AL patients PURPOSE Based on the success of hematopoietic stem-cell transplantation ( HSCT ) for multiple myeloma , HSCT is being used to treat patients with primary systemic amyloidosis ( AL ) . This article addresses the extent to which eligibility to undergo HSCT is a favorable prognostic feature and explores prognostic factors within the subset of eligible patients . PATIENTS AND METHODS The Mayo Clinic amyloid data base was queried for all patients with AL seen at the Mayo Clinic from 1983 through 1997 who would have been eligible for peripheral-blood stem-cell transplantation . Inclusion criteria included biopsy-proven amyloid , symptomatic disease , absence of a clinical diagnosis of multiple myeloma , age < or = 70 years , cardiac interventricular septal thickness < or = 15 mm , cardiac ejection fraction more than 55 % , serum creatinine < or = 2 mg/dL , and direct bilirubin < or = 2.0 mg/dL. RESULTS Median age was 56 years ( range , 25 to 70 ) with 79 ( 34 % ) older than 60 years . One hundred patients had early cardiac involvement ; 41 , hepatic involvement ; 167 , renal involvement ; and 39 , nerve involvement . The 229 patients have had a median follow-up of 52 months , and 151 have died . The median survival was 42 months with 5- and 10-year survival rates of 36 % and 15 % , respectively . Important predictors of survival were size of M-component in 24-hour urine , number of involved organs , alkaline phosphatase , performance score , and weight loss . CONCLUSION The same patients who are eligible for HSCT are a good-risk population who do relatively well with chemotherapy ( median survival , 42 months ) , substantially better than the expected median survival of 18 months for all patients with AL . A r and omized trial is needed to assess the true effect of HSCT Current therapy of primary systemic ( AL ) amyloidosis with oral melphalan and prednisone remains unsatisfactory , with a median survival of only 13 months . Between 1996 and 2003 , 93 patients with biopsy-proven AL amyloidosis were enrolled in a prospect i ve US national cooperative group trial . Treatment schema consisted of induction therapy with pulse dexamethasone ( DEX ) , followed by maintenance therapy with DEX and alpha interferon . Hematologic complete remissions were observed in 24 % and improvement in AL amyloidosis-related organ dysfunction occurred in 45 % of patients evaluable for response . Median survival of the entire cohort is 31 months , with an estimated 2-year overall survival ( OS ) and event-free survival ( EFS ) of 60 % and 52 % , respectively . Presence of congestive heart failure and increased level of serum beta2 microglobulin ( > /= 0.0035 g/L [ 3.5 mg/L ] ) were dominant predictors of adverse outcome . Estimated 2-year OS in patients who are eligible to receive transplants with this approach was 78 % . These data demonstrate for the first time in the context of a US multicenter prospect i ve clinical trial that front-line therapy with a DEX-based regimen in AL amyloidosis can lead to durable reversal of AL amyloidosis-related organ dysfunction and prolonged survival This study investigated the response rate and toxicity of blood cell transplantation as treatment for primary amyloidosis ( AL ) . Twenty-three patients had stem cells collected between November 1995 and September 1998 . Conditioning included melphalan and total body irradiation in 16 and melphalan alone in 4 . Three patients did not undergo stem cell infusion because of poor performance status . Two died of progressive amyloid at 1 and 3 months . One patient is alive on hemodialysis . Fourteen males and six females ( median age , 57 years ) underwent transplantation . Renal , cardiac ( by echocardiography ) , peripheral neuropathy or liver amyloidosis occurred in 14 , 12 , 3 , and 1 , respectively . Echocardiography demonstrated an interventricular septal thickness ⩾15 mm in six patients , five of whom died post transplantation . Three patients died of progressive amyloidosis at 7 , 7 , and 21 months . Thirteen patients are alive with a follow-up of 3 to 26 months . Twelve ( 60 % ) fulfilled the criteria of a hematologic or organ response . Severe gastrointestinal tract toxicity was seen in five ( 25 % ) . We conclude that blood cell transplantation for amyloidosis had a much higher morbidity and mortality compared with transplantation for myeloma . The best results appear to occur in patients with nephrotic syndrome as the only manifestation of their disease . Bone Marrow Transplantation ( 2000 ) 26 , 963–969 Context AL amyloidosis responds poorly to oral chemotherapy and rarely leads to elimination of plasma cell dyscrasia . Amyloid cardiomyopathy is a particularly fatal complication of the disease . Contribution Analysis of consecutive patients with AL amyloidosis from 6 separate trials over 8 years shows that high-dose intravenous melphalan therapy combined with autologous stem-cell transplantation greatly improves duration of survival and ameliorates organ dysfunction . Implication s Intravenous melphalan therapy combined with stem-cell transplantation represents a clinical ly significant improvement in treating AL amyloidosis and shows promise in reversing amyloid cardiomyopathy . The Editors The most common form of systemic amyloidosis in the United States is AL ( or primary ) amyloidosis . In this disease , amyloid fibrils are derived from monoclonal immunoglobulin light chains that are produced by an underlying clonal plasma cell dyscrasia . Although the burden of plasma cells is generally low , accumulation of amyloid deposits in vital organs leads to progressive disability and death . The median survival of untreated patients after diagnosis is 12 months and less than 5 months for those with cardiomyopathy ( 1 - 5 ) . AL amyloidosis is reported to occur in 5 to 12 persons per million per year in the United States ; however , death records and autopsy results suggest that the incidence may be higher ( 6 , 7 ) . Treatment with oral melphalan results in a modest increase in median survival but rarely eliminates the plasma cell dyscrasia and is not effective for rapidly progressive disease ( 8 - 10 ) . Alternative chemotherapy regimens have not improved survival further ( 11 - 15 ) . Promising treatment outcomes observed with high-dose intravenous melphalan and autologous stem-cell transplantation in multiple myeloma ( 16 - 19 ) provided a rationale for testing the hypothesis that this treatment would improve survival for patients with AL amyloidosis . Favorable responses to high-dose melphalan and stem-cell transplantation in patients with AL amyloidosis have been reported in case reports and in small series ; however , treatment-related mortality was high in multicenter trials ( 20 - 28 ) . Our initial experience with treatment in AL amyloidosis indicated that selected patients can tolerate treatment and that hematologic responses and reversal of amyloid-related organ dysfunction can be achieved ( 29 - 32 ) . Since 1994 , we have evaluated 701 patients with AL amyloidosis , 312 of whom initiated high-dose melphalan treatment and stem-cell transplantation . This longitudinal study examines survival , hematologic response , and improvement of amyloid-related organ disease in patients who were treated with high-dose melphalan and stem-cell transplantation . We contrast these data with features and survival of a simultaneous cohort of patients who were not eligible for treatment . Methods Patients Between July 1994 and June 2002 , 701 consecutive patients with AL amyloidosis were evaluated and clinical data were collected with the approval of the Institutional Review Board of Boston University Medical Center . All patients had biopsy-proven amyloid disease and a documented plasma cell dyscrasia , which was diagnosed by the presence of clonal plasma cells in the bone marrow or a monoclonal gammopathy detected by immunofixation electrophoresis of serum or urine proteins ( Figure 1 ) . To exclude another type of systemic amyloidosis and a monoclonal gammopathy of unknown significance , all patients with findings compatible with familial or secondary ( AA ) amyloidosis were tested by DNA analysis for gene mutations in transthyretin , apolipoprotein A1 , fibrinogen , and lysozyme known to be associated with amyloidosis and by immunohistochemistry of the biopsy tissue for AA amyloid fibril deposits ( 33 ) . Patients with multiple myeloma ( bone marrow plasmacytosis 30 % or lytic bone lesions ) were excluded . In patients older than 70 years of age with cardiomyopathy only , a diagnosis of senile cardiac amyloidosis ( caused by wild-type transthyretin ) was excluded by immunohistochemical examination of a tissue biopsy specimen using antiserum to transthyretin . All patients were evaluated for degree of organ involvement by physical examination , st and ardized blood tests , electrocardiography , echocardiography , chest radiography , pulmonary function tests , and a 24-hour urine collection . All patients were evaluated by a hematologist and cardiologist and , when appropriate , by nephrology , pulmonology , gastroenterology , and neurology specialists . Figure 1 . Algorithm for patient selection and treatment with high-dose melphalan and stem-cell transplantation . High-Dose Melphalan and Stem-Cell Transplantation Eligibility and Protocol s Patients were enrolled in several sequential institutional review boardapproved protocol s during the 8-year study period . Eligibility criteria for all protocol s required biopsy-proven amyloid disease ; evidence of a plasma cell dyscrasia ; at least 1 major organ affected by amyloid disease ; and minimum measures of cardiac , pulmonary , and performance status ( Figure 1 ) . Functional measures included cardiac ejection fraction 0.4 or greater , absence of symptomatic pleural effusions , absence of heart failure or arrhythmia resistant to medical management , oxygen saturation of 95 % or greater on room air , lung diffusing capacity of 50 % or more of predicted , supine systolic blood pressure of 90 mm Hg or greater , and Southwest Oncology Group performance status score of 2 or less unless limited by neuropathy ( on a scale of 0 to 4 , reflecting percentage of the day [ 0 % , 25 % , 50 % , 75 % , or 100 % ] spent in bed or in a chair ) . Minor variations in eligibility requirements for age , renal function , amount of previous chemotherapy , and time from diagnosis while on some protocol s are noted in the following discussion ; the number of patients affected is also given . The first protocol ( July 1994 to December 1995 ) enrolled 13 patients 60 years of age or younger with serum creatinine values of 176.8 mol/L ( 2.0 mg/dL ) or less ; these patients were treated with melphalan , 200 mg/m2 ( 29 ) . Subsequent protocol s had no restriction for impaired renal function . A second protocol ( April 1995 to October 1996 ) enrolled 28 patients 70 years of age or younger and used a lower dose of melphalan , 100 mg/m2 ( 31 ) . Two protocol s ( January 1996 to June 1998 ) evaluated the use of CD34 + -selected stem cells in 16 patients ( 34 ) . The fifth protocol ( October 1996 to September 2000 ) r and omly assigned 100 previously untreated patients to treatment with high-dose melphalan and stem-cell transplantation immediately or after 2 cycles of oral melphalan and prednisone . There was no age limit for this protocol ; however , melphalan , 140 mg/m2 , was given to patients who were older than 65 years of age or had a cardiac ejection fraction between 0.40 and 0.44 . The sixth protocol ( November 2000 to the present ) has enrolled 29 patients 65 years of age or younger . On this protocol , enough stem cells are collected initially to give a second cycle of chemotherapy within the first year if a complete response has not been achieved after an initial course of melphalan at a dose of 200 mg/m2 . Other patients who met eligibility criteria ( August 1996 to the present ) but were excluded from an active protocol because of previous treatment or time from diagnosis were treated by using the established dosing guidelines . Patients who did not meet eligibility for treatment with high-dose melphalan and stem-cell transplantation were grouped according to reasons for in eligibility and were analyzed for survival . Organ system involvement was defined by physical examination ; postural blood pressure determinations ; st and ardized serologic laboratory measurements of kidney , liver , and endocrine function ; coagulation studies , including factor X levels ; electrocardiography ; echocardiography ; chest radiography ; pulmonary function tests with walking oximetry ; and a 24-hour urine collection for protein excretion . Cardiac involvement was defined by septal or posterior wall thickening of 13 mm or greater on echocardiography or a clinical syndrome of congestive heart failure or cardiac arrhythmia in the absence of preexisting cardiac disease . Renal involvement was diagnosed by proteinuria of 500 mg/24 h or greater or an elevated serum creatinine concentration in the absence of other causes of renal disease . Gastrointestinal involvement was diagnosed by involuntary loss of 10 % of body weight , unexplained diarrhea , hepatomegaly of 4 cm or more below the right costal margin on physical examination , or alkaline phosphatase level 2 or more times the upper limit of normal values . Peripheral neuropathy was diagnosed by symptoms and physical examination or nerve conduction studies , and autonomic neuropathy was defined by orthostatic hypotensiona decrease in systolic blood pressure of 20 mm Hg or greater with upright posture in euvolemic patients . Soft tissue involvement was diagnosed by clinical evidence of macroglossia , soft tissue or subcutaneous deposits , amyloid arthropathy , lymphadenopathy , or nail dystrophy . Coagulation factor X level was considered deficient if it was 50 % or less of normal . Stem-Cell Collection and High-Dose Chemotherapy Peripheral blood stem cells were collected by leukapheresis after mobilization using granulocyte colony-stimulating factor . A minimum yield of 2.0 106 CD34+cells/kg of body weight was required to support high-dose chemotherapy . The patient 's age and cardiac status and the number of stem cells collected determined the melphalan dose ( Figure 1 ) . A dose of 200 mg/m2 was administered to patients who were 65 years of age or younger and who had a cardiac ejection fraction of 0.45 or greater and a stem-cell collection of at least 2.5 106 CD34+cells/kg . A dose of 140 mg/m2 was administered to patients who were older than 65 years of age , who had a cardiac ejection fraction of 0.4 to 0.44 , or who had a stem-cell collection of 2.0 to 2.5 106 Summary : Stem cell transplantation was introduced as a new therapeutic modality for amyloidosis . The purpose of the current study was to determine the feasibility and toxicity of stem cell transplantation for amyloidosis in a cooperative group setting in which most participating institutions would have limited experience in managing the disorder . A total of 30 patients with biopsy-proven amyloidosis shown to be immunoglobulin light-chain type were enrolled on this trial . The protocol required mobilization of a minimum of 6 × 108 mononuclear cells/kg or 5 × 106 CD34 + cells/kg ideal body weight . These targets had to be achieved within seven collection s. Patients with advanced hepatic , renal , or cardiac failure were excluded . End points included objective response rate and overall survival . The secondary end point of the protocol was nonhematologic toxicity . Accrual to the study was faster than expected . The overall response rate ( hematologic and organ ) was 64 % , with three treatment-related deaths . Another patient died before day 30 of sudden cardiac death not treatment related . The median follow-up of surviving patients is 30.3 months . Median survival has not been reached . Stem cell transplantation for selected patients with amyloidosis is feasible in a cooperative group setting . A multicenter phase 3 trial of high-dose therapy is indicated Clinical outcomes of patients with AL amyloidosis treated with high-dose melphalan and stem cell transplantation ( HDM/SCT ) are tightly linked to the achievement of a hematologic complete response ( HCR ) . We conducted a prospect i ve trial to determine whether a second cycle of HDM/SCT could induce HCR in patients in whom the plasma cell dyscrasia persisted following initial treatment with HDM/SCT . Sixty-two patients were enrolled . Nine patients ( 15 % ) were removed from the protocol . Of the 53 patients continuing in this study , four died within 100 days of treatment ( 8 % ) , and 27 ( 55 % ) achieved an HCR at 6 months after the first cycle of HDM/SCT . Of the 22 patients who did not achieve an HCR after initial treatment , 17 received a second HDM/SCT , 1 died within 100 days of treatment ( 6 % ) , while 5 ( 31 % ) achieved an HCR . Thus , the HCR rate was 67 % ( 32/48 ) for surviving patients on study , 60 % ( 32/53 ) for all patients who received initial cycle of HDM/SCT , and 56 % ( 35/62 ) by intention-to-treat . The median survival for all patients enrolled on the trial has not yet been reached . Thus , t and em cycles of HDM/SCT can increase the proportion of patients who achieve an HCR Patients with AL amyloidosis were treated with VAD ( vincristine , doxorubicin and dexamethasone ) with or without high-dose melphalan followed by auto-PBSCT according to eligibility criteria based on disease severity , and prospect ively investigated the therapeutic benefits and complications . Thirty-one patients were enrolled in this study . VAD and subsequent high-dose melphalan with auto-PBSCT were performed only in patients who met all of the eligibility criteria . Among patients ineligible for this treatment , VAD alone was performed in those with satisfactory general status . Eleven patients met the eligibility criteria , and of these , 7 were treated with VAD and subsequent high-dose melphalan with auto-PBSCT . Seven patients received VAD alone , and the remaining 17 were treated with the supportive therapy . Among the 14 patients treated with chemotherapy , 9 ( 5 of the 7 treated with VAD and high-dose melphalan , and 4 of the 7 treated with VAD alone ) showed complete hematological response with apparent improvement of amyloidosis-related clinical symptoms . Serious complications of chemotherapy were cytomegalovirus infection and pneumocystis carinii pneumonia seen in 1 and 2 patients , respectively . These chemotherapies may be effective for reduction of M-protein and are also useful in improving of amyloidosis-induced organ dysfunction . In patients who can not tolerate high-dose melphalan , VAD alone is a potent therapeutic option , although there are possible harmful effects on the heart and peripheral nerve Satisfactory treatment for primary amyloidosis does not exist . Because the amyloid fibrils consist of a portion of a monoclonal light chain , it appears reasonable to treat amyloidosis with alkylating agents that are effective against the plasma cells that synthesize monoclonal light chains . Fifty-five patients with primary systemic amyloidosis were r and omized ( double blind ) to melphalan-prednisone or placebo . In comparison with the placebo group , patients given melphalan-prednisone were able to continue on treatment for a longer time and to receive larger doses before the code was broken . Among this group , the nephrotic syndrome disappeared in two patients and urinary excretion of protein was reduced by more than 50 % in eight others . Of 13 patients who received melphalan-prednisone for more than 12 mo , 6 improved , 3 were stable , and 4 had progression of disease . Survival did not differ significantly between the groups BACKGROUND High-dose intravenous melphalan and autologous peripheral blood stem cell transplantation ( HDM/SCT ) is an effective treatment for AL amyloidosis but is associated with significant toxicity , including the development of acute renal failure ( ARF ) . The incidence and outcome of ARF as a complication of such treatment is not known . METHODS All AL amyloidosis patients treated with HDM/SCT at a single institution between July 1 , 1994 and May 31 , 2000 were included in the analysis unless they were dialysis-dependent prior to treatment . Baseline data were collected prospect ively . Treatment-related data were obtained from a prospect ively maintained data base and medical record review . ARF was defined as either a > /=1 mg/dL increase in serum creatinine or a doubling of serum creatinine to > /=1.5 mg/dL for at least 2 days . Recovery of renal function was defined as a return of serum creatinine to less than or within 0.5 mg/dL of the pretreatment value or the ability to discontinue dialysis initiated as a result of ARF . RESULTS ARF occurred in 37 of 173 patients ( 21 % ) . Initiation of dialysis was required in nine patients ( 5 % ) . Forty-six percent of patients with ARF , including four of nine who required dialysis , had recovery of renal function . Baseline clinical variables that were independent predictors of transplant-associated ARF included creatinine clearance , proteinuria , and cardiac amyloidosis . Treatment-related variables associated with ARF included melphalan dose and bacteremia . ARF was associated with reduced survival at 90 days but did not have an impact on overall survival at a median follow-up of 2.9 years . CONCLUSION ARF is a frequent but often reversible complication of HDM/SCT for AL amyloidosis . Specific clinical and treatment-related factors are associated with the development of this complication Amyloid light chain ( AL ) amyloidosis is the result of a clonal plasma cell expansion , in which monoclonal light chains transform to amyloid deposit in various tissues and can lead to organ dysfunction and organ failure . The median survival of patients with AL amyloidosis without therapy is 10–14 months . With high‐dose melphalan ( HDM ) and autologous stem cell transplantation ( ASCT ) , haematological and clinical remission rates of up to 50 % of treated patients have been reported from phase II studies . HDM followed by ASCT appears to prolong survival in patients , if haematological remission can be reached . In this phase II study , we evaluated vincristine , adriamycin and dexamethasone ( VAD ) as induction chemotherapy prior to stem cell mobilization and HDM with ASCT . The regimen was , in general , feasible in patients with AL amyloidosis , but VAD chemotherapy had a considerable World Health Organization ( WHO ) grade III – IV toxicity ( 25 % ) and mortality ( 7 % ) rate . VAD pretreatment did not interfere with stem cell mobilization and HDM with ASCT was possible in 86 % of patients . The overall treatment efficacy was comparable with reported results of HDM and ASCT without preceding chemotherapy . We could not show an additional benefit of VAD induction in terms of increasing haematological response rate ; however the 13 % mortality rate after HDM and ASCT in our series was lower than the previous report The most efficient therapeutic approach for immunoglobulin light chain amyloidosis ( AL ) is autologous stem cell transplantation ( ASCT ) ; however , the toxicity of ASCT limits its feasibility to a minority of patients . Patients ineligible for ASCT are usually treated with st and ard oral melphalan and prednisone , but the response rate to this regimen is unsatisfactory , and time to response is long . High-dose dexamethasone provides a rapid response time in patients with AL . We evaluated the combination of oral melphalan and high-dose dexamethasone ( M-Dex ) in 46 patients with AL ineligible for ASCT . Thirty-one ( 67 % ) achieved a hematologic response and 15 ( 33 % ) a complete remission . In 22 ( 48 % ) of the responsive patients functional improvement of the organs involved was observed . Five patients ( 11 % ) experienced severe adverse events , 3 required hospitalization , and no treatment-related deaths were observed . M-Dex represents a feasible and effective therapeutic option for patients with advanced AL who are ineligible for ASCT BACKGROUND Primary systemic amyloidosis is an uncommon disease characterized by the accumulation in vital organs of a fibrillar protein consisting of monoclonal light chains . METHODS We treated 220 patients with biopsy-proved amyloidosis . The patients were r and omly assigned to receive colchicine ( 72 patients ) , melphalan and prednisone ( 77 ) , or melphalan , prednisone , and colchicine ( 71 ) . They were stratified according to their chief clinical manifestations : renal disease ( 105 patients ) , cardiac involvement ( 46 ) , peripheral neuropathy ( 19 ) , or other ( 50 ) . RESULTS The median duration of survival after r and omization was 8.5 months in the colchicine group , 18 months in the group assigned to melphalan and prednisone , and 17 months in the group assigned to melphalan , prednisone , and colchicine ( P<0.001 ) . Among patients who had a reduction in serum or urine monoclonal protein at 12 months , the overall length of survival was 50 months , whereas among those without a reduction at 12 months , the overall length of survival was 36 months ( P=0.03 ) . Thirty-four patients ( 15 percent ) survived for five years or longer . CONCLUSIONS Therapy with melphalan and prednisone results in objective responses and prolonged survival as compared with colchicine in patients with primary amyloidosis |
1,343 | 14,974,029 | REVIEW ER 'S CONCLUSIONS The results indicate that exercise has positive short-term effects on self-esteem in children and young people .
Since there are no known negative effects of exercise and many positive effects on physical health , exercise may be an important measure in improving children 's self-esteem . | BACKGROUND Psychological and behavioural problems in children and adolescents are common , and improving self-esteem may help to prevent the development of such problems .
There is strong evidence for the positive physical health outcomes of exercise , but the evidence of exercise on mental health is scarce .
OBJECTIVES To determine if exercise alone or exercise as part of a comprehensive intervention can improve self-esteem among children and young people . | PURPOSE The purpose of this investigation was to examine selected psychobiological responses to acute bouts of resistance exercise ( RE ) of different intensities . METHODS Eighty-four participants were classified as experienced or inexperienced and then r and omly assigned to three conditions : 1 ) 50 % of one repetition maximum(1RM ) , 2 ) 80 % 1RM , or 3 ) control condition . RE consisted of performing three sets of four exercises between 12 to 20 reps in the 50 % 1RM condition and four to eight reps in the 80 % 1RM condition . Dependent variables consisted of state anxiety ( SA ) , mood states ( POMS ) , systolic BP ( SBP ) , diastolic BP ( DBP ) , and heart rate ( HR ) . These variables were assessed before as well as 1 , 20 , 60 , 120 , and 180-min following the conditions . Data were analyzed with a 2 ( experience ) x 3 ( conditions ) x 6 ( trials ) mixed model ANOVA and Tukey post-hoc tests . RESULTS Results indicated that SA decreased significantly ( P < 0.05 ) 180 min following the 50 % 1RM condition . A significant decrease ( P < 0.05 ) in vigor occurred immediately following the 50 % IRM condition and persisted for 20 min . SBP increased significantly ( P < 0.05 ) immediately following the 80 % 1RM condition . HR increased significantly ( P < 0.05 ) following both RE conditions . No significant differences were found between the experienced or inexperienced participants . CONCLUSIONS An acute bout of RE at 50 % 1RM is associated with an immediate reduction in vigor followed by a significant decrease in SA that emerged 180 min following exercise This study compared the physical and psychological effects of running to those of the normal physical education program of activities among 154 fourth , fifth , and sixth grade rs who were r and omly assigned to conditions within a true experimental design . The running program consisted of three 30-min sessions per week for 12 weeks in lieu of attendance in regular physical education classes . Findings showed that although boys tended to run faster than girls overall and that older children run faster than younger children , running-program participants performed better on an 800-m run , had lower pulse rates , and performed better on a test of creativity than did regular physical education participants . Running boys had less body fat , and running girls had more creative involvement in class . No differences were found on 50-m dash performance or perceptual skill . On total behavior , girls were more self-controlled than boys , and self-concept tended to become less positive with increased grade level . Running performance for 800 m persisted for 5 months among boys in the treatment , but not among girls . Running was judged effective for enhancing the cardiorespiratory health and creativity of school children Use of adventure as an intervention in traditional counseling was explored with 84 adolescent clients from two community-based counseling agencies and residents from two boys ' homes . The adolescents were assigned to conditions of counseling plus adventure experiences , counseling only , adventure only , or a control . Analysis indicated limited support for increasing self-esteem and social skills by adding adventure experiences to on-going counseling To determine whether participating in physical activity affects psychological well-being in an adolescent population , 147 adolescents completed self-reports of exercise and psychological stress and well-being . Analysis revealed that those who reported greater physical activity also reported less stress and lower levels of depression . Adolescents who experienced a higher incidence of life events also demonstrated a strong association between stress and anxiety/depression/hostility . To investigate the effects of exercise training on psychological well-being , adolescents were assigned to either high or moderate intensity aerobic training , flexibility training or a control group . The training groups met twice per week for 25 - 30 min . Aerobic fitness levels , heart rate , blood pressure and self-report of stress and well-being were measured prior to and following 10 weeks of training . Post-training fitness measures confirmed the effectiveness of the high intensity aerobic exercise and between groups differences for physiological and some psychological measures were found . Subjects undergoing high intensity exercise reported significantly less stress than subjects in the remaining three groups . The relationship between stress and anxiety/depression/hostility for the high intensity group was considerably weakened at the end of the training period . For the remaining subjects , however , this relationship was , if anything , strengthened . This experiment provides evidence to suggest that in an adolescent population , high intensity aerobic exercise has positive effects on well-being Aerobic exercise which result ed in a significant improvement in cardiovascular functioning had no more effect on psychological mood states than did the placebo control of participation in nonaerobic recreational games or no exercise and sport at all ( N = 430 college students ) . Beta-endorphin levels with the 41 depressed subjects were not a biochemical link that might explain the possible influence of physical activity on depression Abstract This study was design ed to assess the effects of a specifically design ed perceptual-motor training program on the level of perceptual-motor development , self-concept , and academic ability of kindergarten children . Subjects for the study were 40 kindergarten children r and omly assigned to 1 of 2 groups . Each group received the same kindergarten program with one exception , the experimental group was exposed to a specifically design ed perceptual-motor program 30 min daily for 5 mo , while the control group received a free play period for 30 min daily . Results of the study indicated that the data tended to support the specificity of training concept . The variables showing the greatest change were the perceptual-motor tests which measured changes on specific aspects of the training program . There appeared to be some immediate transfer to academic abilities but this was not pronounced enough to suggest that perceptual-motor training was of real benefit in developing academic abilities for normal kinderga The purpose of this study was to examine self-esteem changes in school aged children enrolled in weight management programs . The study group was comprised of 54 obese children ages 10 - 15 enrolled in a weight management program . The control group was comprised of 60 obese children who had never been enrolled in a weight management program . Each child was measured for body mass index ( BMI ) and weight . All the children filled out the Pier-Harris Children 's Self-Concept Scale at the beginning of the study and 12 weeks later following the study group 's completion of the weight management program . The groups were similar in average age , weight , BMI , and self-concept score at the beginning of the study . At the end of the 12 weeks , there was no significant change in the average weight or BMI in either the study or control group . There was a significant decrease in the self-concept score in the study group but not in the control group . The greatest score changes came from the physical appearance subscale . Participation in weight management programs may put children at risk for lower self-esteem ( self-concept ) while producing limited weight loss results OBJECTIVE This study examines the effect of an interactive , school-based , self-esteem education program on the body image and eating attitudes and behaviors of young male and female adolescents following the program and after 12 months . METHOD All 470 eligible students ( 63 % female ) aged 11 - 14 years volunteered to participate . The intervention group students participated in the program , whereas the control group students received their scheduled personal development and health class . RESULTS The program significantly improved the body satisfaction of the intervention students and significantly changed aspects of their self-esteem ; social acceptance , physical appearance , and athletic ability became less important for the intervention students and more important for control students . Female intervention students rated their physical appearance as perceived by others significantly higher than control students and allowed their body weight to increase appropriately by preventing the age increase in weight-losing behaviors of the control students . One year after the intervention , body image and attitude changes were still present . These findings also held for the 116 students ( 63 % females ) with low self-esteem and higher anxiety , who were considered at risk for the development of eating disorders . These students also had significantly lower drive for thinness and greater body satisfaction following the intervention and the decreased importance of physical appearance to their self-esteem was present at 12 months . Control at-risk students significantly decreased their body weight , whereas the weight of the intervention at-risk students significantly increased . The intervention program was effective , safe , having no effect on measures of students ' anxiety or depression , and was rated highly by students . DISCUSSION This is the first controlled educational intervention to successfully improve body image and to produce long-term changes in the attitudes and self-image of young adolescents . This new approach to prevent the development of eating disorders by improving self-esteem may be effective , particularly if reinforced by teachers and family Summary The purpose of this study was to investigate the effects of a cardiovascular fitness program on the self-concept and peer approval of seventh grade boys . Thirty-seven low self-esteem Ss were r and omly divided into a control group ( participated in no formal physical education activity ) and an experimental group ( participated in a special running training program ) . At the end of an 18 week training program the two groups were significantly different in cardiovascular endurance , indicating the efficacy of the experimental treatment . There was an increase in self-concept from pretest to posttest for the experimental group only . Neither group had a significant change in peer approval 36 boys and 36 girls in 4 fourth grade s were exposed to basketball movement conditions which included the skills of dribble , chest pass , lay-up , pivot , guarding , and two-h and set shot . Eight 1/2-hr . treatment periods were spread evenly over 4 wk . and took place within the regularly assigned school physical education period . Two class groups , which included 9 boys and 9 girls each , were r and omly assigned by class to an experimental group which received treatment while two class groups were assigned by class to the control group . No differences between changes in self-concept as estimated by the Piers-Harris scale for treatment and control conditions were significant Aerobic exercise has been associated with improvements in psychological status and physical fitness in adults , but its effects on children are less clear . The purpose of this study was to evaluate the effects of an aerobic exercise program on the self-concept , academic achievement , motor proficiency , and cardiovascular fitness of boys with learning disabilities . Fifty-four boys were r and omly assigned to one of two exercise programs lasting 20 weeks . One program emphasized aerobic exercise and the other consisted of similar but less vigorous activities . The self-concept , academic achievement , motor proficiency , and physical fitness of each subject was assessed before and after the exercise programs . The results from group comparisons demonstrated an association between the aerobic exercise program and improvement of self-concept and physical fitness . No effect on academic achievement or motor proficiency could be attributed to the aerobic exercise program . J Dev Behav Pediatr 8:274–277 , 1987 . Index terms : aerobic exercise , learning disabilities , sports , self-concept This study investigated a possible relationship between exercise intensity and mood alteration that commonly is associated with physical activity . 91 college students completed the Profile of Mood States before and after 20 min . of jogging at three intensities : 55 % , 75 % , and 79 % of age-adjusted maximum heart rate on different occasions . Exercisers also completed a demographic inventory , a Lie Scale , and the State-Trait Anxiety Inventory . Contrary to our expectations , the interaction between exercise intensity and pre-post mood benefits was not significant . Supporting the manipulation of exercise intensity , the univariate interaction between exercise intensity and pre-post exercise scores on Fatigue was significant . Joggers reported short-term mood benefits on the combined subscales of the Profile of Mood States , and each subscale contributed to the benefits . Thus , regardless of the low- or moderate-intensity , participants reported that they “ felt better ” after exercising The article examines whether participation in an aerobic exercise program ( AE ) , as compared with a traditional physical education class ( PE ) , significantly increased children 's perceived athletic competence , physical appearance , social acceptance , behavioral conduct , and global self-worth ; increased their figural creativity ; and improved aerobic power as measured by an 800-meter run around a track . Further research on the effects of different types of AE is discussed , as well as the need for aerobic conditioning in the elementary school This study investigated the relationship between improvement in Total Positive Self-concept scores and increase in sports skills before and after training of 10 weeks for 45 minutes daily by 12- to 14-yr.-old junior high school and 16- to 18-yr.-old senior high school boys and girls . The 288 subjects were selected using a stratified ( intact class ) r and om technique . Subjects were r and omly assigned to different sports , 96 to field-hockey and 96 to athletics ( 32 to discuss , 32 to long jump , and 32 to sprints ) . 96 control subjects were r and omly selected from one class of each age bracket . Analysis of covariance showed that the trained subjects scored significantly higher in total positive self . A positive correlation between gain in sports skill and increase in self-concept scores was noted for both boys and girls within each age group . Age and sex had no effect on this pattern . The result supports inclusion of success-oriented sports in the high school curriculum Aerobic exercise has been associated with improved psychological status and physical fitness in adults , but its effects in adolescents have been less clear . This study evaluated the effects of aerobic exercise on the self-concept , depression level , and physical fitness of juvenile delinquents . Ninety-eight incarcerated youths who volunteered to participate were assigned in a blind fashion to one of two exercise programs lasting three months . Sixty-nine completed all phases of the study and are the subjects of this report . One exercise program ( 32 subjects ) emphasized aerobic exercise ; the other ( 37 subjects ) , limited exertion . Before and after participating , each subject underwent measurement of self-concept , mood , and physical fitness . While the aerobic and comparison groups were initially similar , the data demonstrated an association between participation in the aerobic exercise program and improved self-concept , mood , and fitness . Improvement in psychological variables was not dependent on improved physical fitness and was not related to preintervention measures |
1,344 | 19,917,883 | Assay of BNP or NT-proBNP in addition to measurement of conventional CVD risk factors yielded generally modest improvements in risk discrimination .
Available prospect i ve studies indicate strong associations between circulating concentration of natriuretic peptides and CVD risk under a range of different circumstances . | BACKGROUND Measurement of B-type natriuretic peptide ( BNP ) concentration or its precursor ( N-terminal fragment [ NT-proBNP ] ) is recommended in patients with symptoms of left ventricular dysfunction and in other setting s , but the relevance of these peptides to cardiovascular disease ( CVD ) in general population s or in patients with stable vascular disease is uncertain . | BACKGROUND Heart failure ( HF ) is an important cause of morbidity in patients with acute coronary syndromes ( ACS ) . C-reactive protein ( CRP ) has been implicated in experimental models as exacerbating myocardial injury , but data regarding the clinical relationship of high-sensitivity CRP ( hsCRP ) and B-type natriuretic peptide ( BNP ) concentrations with the risk of HF after ACS are few . METHODS PROVE IT-TIMI 22 r and omized 4162 patients who had been stabilized after ACS to either intensive or moderate statin therapy . hsCRP and BNP were measured 30 days after r and omization . Hospitalizations for HF and cardiovascular death occurring after day 30 were assessed for a mean follow-up of 24 months . RESULTS Patients who developed HF had higher concentrations of hsCRP ( 3.7 mg/L vs 1.9 mg/L , P < 0.001 ) and BNP ( 59 ng/L vs 22 ng/L , P < 0.0001 ) . HF increased in a stepwise manner with hsCRP quartile [ adjusted hazard ratio ( HR(adj ) ) for Q4 vs Q1 , 2.5 ; P = 0.01 ] and BNP quartile ( HR(adj ) for Q4 vs Q1 , 5.8 ; P < 0.001 ) , with similar results obtained for HF and cardiovascular death . In a multivariable analysis , higher concentrations of hsCRP and BNP were both independently associated with HF [ HR(adj ) , 1.9 for hsCRP > 2.0 mg/L ( P = 0.01 ) and 4.2 for BNP > 80 ng/L ( P < 0.001 ) ] . Patients with increases in both markers were at the greatest risk of HF , compared with patients without an increased marker concentration ( HR(adj ) , 8.3 ; P = 0.01 ) . The benefit of intensive statin therapy in reducing HF was consistent among all patients , regardless of hsCRP or BNP concentration . CONCLUSIONS Both hsCRP and BNP measured 30 days after ACS are independently associated with the risk of HF and cardiovascular death , with the greatest risk occurring when both markers are increased AIMS This study evaluated the predictive value of NT-proBNP for patients with diabetes mellitus and compared the prognostic aptitude of this neurohumoral marker to traditional markers of cardiovascular events . METHODS AND RESULTS A prospect i ve observational study was conducted in 631 diabetic patients . The composite endpoint consisted of unplanned hospitalization for cardiovascular events or death within the observation period of 12 months . Of all variables analysed ( age , gender , history of hypertension , ischaemic heart disease/any cardiac disease , smoking , duration of diabetes , body mass index , blood pressure , New York Heart Association-class , Dyspnoea score , Minnesota Living with Heart Failure Question naire , LDL-cholesterol , HbA(1c ) , creatinine , glomerular filtration rate ) , the logarithm of NT-proBNP gave the most potent information in a stepwise Cox regression analysis ( P < 0.0001 ) . Bootstrapping with 500 sample s supports this result in 95 % sample s. The negative predictive value of a normal value ( < 125 pg/mL ) of NT-proBNP for short-term cardiovascular events in diabetic patients is 98 % . CONCLUSION We have demonstrated a strong and independent correlation between NT-proBNP and short-term prognosis of cardiovascular events for patients with diabetes mellitus . With a high negative predictive value it can identify individuals who are not at intermediate risk for cardiovascular events . NT-proBNP proved to be of higher predictive value than traditional cardiovascular markers , in this unselected cohort CONTEXT Identification of individuals at high risk for cardiovascular events is important for the optimal use of primary and secondary prevention measures . OBJECTIVE To determine whether plasma levels of amino terminal fragment of the prohormone brain-type natriuretic peptide ( NT-proBNP ) predict cardiovascular events or death independent of other available prognostic tests . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study ( 2000 - 2002 ) of 987 individuals in California with stable coronary heart disease in the Heart and Soul Study , who were followed up for a mean of 3.7 ( range , 0.1 - 5.3 ) years . MAIN OUTCOME MEASURES The association of baseline NT-proBNP levels with death or cardiovascular events ( myocardial infa rct ion , stroke , or heart failure ) . Traditional clinical risk factors , echocardiographic measures , ischemia , other biomarkers , and New York Heart Association classification were adjusted for to determine whether NT-proBNP levels were independent of other prognostic factors . Receiver operating characteristic ( ROC ) curves were used to assess the incremental prognostic value of adding NT-proBNP level to these other measures . RESULTS A total of 256 participants ( 26.2 % ) had a cardiovascular event or died . Each increasing quartile of NT-proBNP level ( range of quartile 1 , 8.06 - 73.95 pg/mL ; quartile 2 , 74 - 174.5 pg/mL ; quartile 3 , 175.1 - 459 pg/mL ; quartile 4 , > or = 460 pg/mL ) was associated with a greater risk of cardiovascular events or death , ranging from 23 of 247 ( annual event rate , 2.6 % ) in the lowest quartile to 134 of 246 ( annual event rate , 19.6 % ) in the highest quartile ( unadjusted hazard ratio [ HR ] for quartile 4 vs quartile 1 , 7.8 ; 95 % confidence interval [ CI ] , 5.0 - 12.1 ; P<.001 ) . Each SD increase in log NT-proBNP level ( 1.3 pg/mL ) was associated with a 2.3-fold increased rate of adverse cardiovascular outcomes ( unadjusted HR , 2.3 ; 95 % CI , 2.0 - 2.6 ; P<.001 ) , and this association persisted after adjustment for all of the other prognostic measures ( adjusted HR , 1.7 ; 95 % CI , 1.3 - 2.2 ; P<.001 ) . The addition of NT-proBNP level to st and ard clinical assessment and complete echocardiographic parameters significantly improved the area under the ROC curves for predicting subsequent adverse cardiovascular outcomes ( 0.80 for clinical risk factors and echocardiographic parameters plus log NT-proBNP vs 0.76 for clinical risk factors and echocardiographic parameters only ; P = .006 ) . CONCLUSIONS Elevated levels of NT-proBNP predict cardiovascular morbidity and mortality , independent of other prognostic markers , and identify at-risk individuals even in the absence of systolic or diastolic dysfunction by echocardiography . Level of NT-proBNP may help guide risk stratification of high-risk individuals , such as those with coronary heart disease Aims /hypothesisRaised N-terminal pro-brain natriuretic peptide ( NT-proBNP ) is independently associated with an increased risk of death in chronic heart failure and acute coronary syndromes in nondiabetic population s. Diabetic nephropathy is characterised by an increased risk of cardiovascular morbidity and mortality . This study investigated the prognostic value of NT-proBNP in a large cohort of type 1 diabetic patients with and without diabetic nephropathy . Methods In a prospect i ve observational follow-up study , 198 type 1 diabetic patients with overt diabetic nephropathy ( 122 men , age [ mean±SD ] 41±10 years , duration of diabetes 28±8 years , GFR 74±33 ml min−1 ) and a matched control group of 188 patients with longst and ing type 1 diabetes and persistent normoalbuminuria ( 114 men , age 43±10 years , duration of diabetes 27±9 years ) were followed for 9.3 ( 0.0–9.5 ) years . Plasma NT-proBNP concentration was determined by immunoassay at baseline . Results In patients with diabetic nephropathy , plasma NT-proBNP concentration was elevated to ( median [ range ] ) 110 ( 5–79640 ) ng l−1 vs. 27 ( 5–455 ) ng l−1 in normoalbuminuric patients ( p<0.0001 ) . Among patients with nephropathy , 39 ( 39 % ) patients with plasma NT-proBNP concentrations above the median and 12 ( 12 % ) with values below the median died from any cause ( unadjusted hazard ratio 3.86 [ 95 % CI 2.02–7.37 ] , p<0.0001 ; covariate-adjusted hazard ratio 2.28 [ 1.04–4.99 ] , p=0.04 ) . This lower mortality rate was attributable to fewer cardiovascular deaths : 31 ( 31 % ) and 7 ( 7 % ) above and below the median NT-proBNP level respectively ( unadjusted hazard ratio 5.25 [ 2.31–11.92 ] , p<0.0001 ; covariate-adjusted hazard ratio 3.81 [ 1.46–9.94 ] , p=0.006 ) . Conclusions /interpretationElevated circulating NT-proBNP is a new independent predictor of the excess overall and cardiovascular mortality in diabetic nephropathy patients without symptoms of heart failure OBJECTIVES The purpose of this work was to assess the prognostic role of glomerular filtration rate ( GFR ) and NT-terminal pro-B-type natriuretic peptide ( NT-proBNP ) for mortality end points in the vascular population . BACKGROUND The GFR and NT-proBNP have been shown to predict mortality end points in free-living and limited vascular population s , independent of traditional risk factors . However , their prognostic power in an unrestricted vascular population is poorly understood . METHODS A total of 412 subjects from a vascular cohort with a history of either peripheral arterial disease ( PAD ) and /or other cardiovascular disease ( CVD ) were included in this prospect i ve cohort analysis and followed for an average of 6.7 years . Outcome variables were all-cause mortality , ischemic heart disease ( IHD ) mortality , and any cardiovascular mortality . The prognostic roles of GFR and NT-proBNP levels were determined using multivariate survival analysis . RESULTS Higher GFR ( per 10 ml/min/1.73 m2 ) was significantly protective for all-cause mortality ( hazard ratio [ HR ] 0.81 , p < 0.001 ) , IHD mortality ( HR 0.82 , p = 0.008 ) , and CVD mortality ( HR 0.84 , p = 0.005 ) . Conversely , NT-proBNP was not a significant predictor of any mortality end point . The GFR showed the strongest association in subjects with a history of other CVD . Although NT-proBNP did not demonstrate a significant prognostic role in any of the subgroups , the data were suggestive for patients with PAD alone . CONCLUSIONS Glomerular filtration rate was a robust predictor of all-cause , IHD , and cardiovascular mortality in the vascular population , particularly in those with a history of other CVD , while NT-proBNP showed a suggestive association limited to the group with PAD only . These findings suggest that these markers must be selectively applied in the vascular population for greatest clinical utility Objective : To evaluate N-terminal pro-brain natriuretic peptide ( NT-proBNP ) as a diagnostic and prognostic marker for systolic heart failure in the general population . Design : Study participants , r and omly selected to be representative of the background population , filled in a heart failure question naire and underwent pulse and blood pressure measurements , electrocardiography , echocardiography , and blood sampling and were followed up for a median ( range ) period of 805 ( 60−1171 ) days . Setting : Participants were recruited from four r and omly selected general practitioners and were examined in a Copenhagen university hospital . Patients : 382 women and 290 men in four age groups ( 50−59 ( n = 174 ) ; 60−69 ( n = 204 ) ; 70−79 ( n = 174 ) ; ⩾ 80 years ( n = 120 ) ) . Main outcome measures : Value of NT-proBNP in evaluating patients with symptoms of heart failure and impaired left ventricular ( LV ) systolic function ; prognostic value of NT-proBNP for mortality and hospital admissions . Results : In 38 ( 5.6 % ) participants LV ejection fraction ( LVEF ) was ⩽ 40 % . NT-proBNP identified patients with symptoms of heart failure and LVEF ⩽ 40 % with a sensitivity of 0.92 , a specificity of 0.86 , positive and negative predictive values of 0.11 and 1.00 , and area under the curve of 0.94 . NT-proBNP was the strongest independent predictor of mortality ( hazard ratio ( HR ) = 5.70 , p < 0.0001 ) , hospital admissions for heart failure ( HR = 13.83 , p < 0.0001 ) , and other cardiac admissions ( HR = 3.69 , p < 0.0001 ) . Mortality ( 26 v 6 , p = 0.0003 ) , heart failure admissions ( 18 v 2 , p = 0.0002 ) , and admissions for other cardiac causes ( 44 v 13 , p < 0.0001 ) were significantly higher in patients with NT-proBNP above the study median ( 32.5 pmol/l ) . Conclusions : Measurement of NT-proBNP may be useful as a screening tool for systolic heart failure in the general population AIMS The prognostic significance of N-terminal pro-A-type ( NT-proANP ) and pro-B-type natriuretic peptides ( NT-proBNP ) is not well documented in population -based prospect i ve studies . We , therefore , studied if both NT-proANP and NT-proBNP are predictive for overall death , cardiovascular events , and atrial fibrillation ( AF ) among middle-aged men without heart failure or AF at baseline . METHODS AND RESULTS Plasma NT-proANP and NT-proBNP were measured in a representative population -based sample of 905 men ( age 46 - 65 years ) from eastern Finl and . There were 110 deaths [ 58 cardiovascular and 40 coronary heart disease ( CHD ) ] and 59 cases of AF during a follow-up of 10 years . The multivariable adjusted risk for overall was 1.35-fold ( 95 % CI 1.15 - 1.57 ) and 1.52-fold ( 95 % CI 1.21 - 1.91 ) for CHD death for each SD ( 160.8 pmol/L ) increment in NT-proANP . The respective risks were 1.26-fold ( 95 % CI 1.12 - 1.42 ) and 1.44-fold ( 95 % CI 1.22 - 1.60 ) for each SD ( 58.9 pmol/L ) increment in NT-proBNP . The adjusted risks for future AF were 1.46 ( P<0.001 ) and 1.72-fold ( P<0.001 ) for each SD increment in NT-proANP and NT-proBNP , respectively . CONCLUSION The main finding of the present study is that NT-proANP and NT-proBNP are strong predictors of death from cardiovascular and other causes including AF . These natriuretic peptides add to the prognostic value of conventional risk factors and provide a non-invasive measure for identifying men with high risk of death and its co-morbidities OBJECTIVES The aim of this study was to assess the predictive value of the cardiac hormone B-type natriuretic peptide ( BNP ) for long-term outcome in a large cohort of stable angina patients . BACKGROUND Recent data suggest a role of BNP in stable ischemic heart disease beyond its known value in heart failure and acute coronary syndromes . METHODS In 1,085 patients with coronary artery disease ( CAD ) baseline levels of BNP were prospect ively associated with cardiovascular ( CV ) events during a mean follow-up of 2.5 years . RESULTS BNP concentrations were significantly elevated in patients with future CV events ( median [ 25th/75th interquartile range ] 119.2 [ 43.6/300.4 ] pg/ml vs. 36.2 [ 11.3/94.6 ] pg/ml ; p < 0.001 ) . Kaplan-Meier survival analysis showed a stepwise decrease in event-free survival across quartiles of BNP baseline concentration ( p(log rank ) < 0.001 ) . Patients in the highest quartile revealed a 6.1-fold increased risk ( p = 0.001 ) compared to patients in the lowest quartile after adjustment for potential confounders . For a cut-off value of 100 pg/ml , an independently increased risk of adverse outcome ( hazard ratio [ HR ] 4.4 ; p < 0.001 ) could be demonstrated . One st and ard deviation ( SD ) decrease in ejection fraction implied the most prominent increase in risk of future CV events ( HR 1.69 ; p < 0.001 ) followed by one SD increase in BNP ( HR 1.53 ; p < 0.001 ) . The highest prognostic accuracy could be demonstrated for BNP ( area under the curve 0.671 ) . CONCLUSIONS The data of this large group of CAD patients provide independent evidence that BNP is a strong predictor of cardiovascular risk in patients with stable angina independent of left ventricular systolic performance and known risk factors OBJECTIVES The aim of this research was to describe N-terminal part of the pro-B-type natriuretic peptide ( NT-proBNP ) levels over time in non-ST-segment elevation acute coronary syndromes ( NSTEACS ) , to eluci date factors associated with changes of NT-proBNP levels , and to examine association with long-term mortality . BACKGROUND The NT-proBNP levels are associated with mortality . Long-term temporal changes of NT-proBNP levels and their relation to other factors have not been examined . METHODS The NT-proBNP was analyzed at r and omization and at 48 h , after 6 weeks , 3 and 6 months in NSTEACS patients enrolled in the Fragmin and fast Revascularisation during InStability in Coronary artery disease (FRISC)-II trial . The NT-proB-type natriuretic peptide was analyzed at least three time points in 1,216 patients . RESULTS The median NT-proBNP level , which at r and omization was 529 ng/l , decreased throughout the whole sampling period to 238 ng/l at six months . Elevated troponin T , C-reactive protein , and female gender were associated with higher reduction rates , and high age , diabetes , previous myocardial infa rct ion , treatment with diuretics , and nitrates on admission with lower reduction rates . At each time point , the NT-proBNP level was predictive of the two-year mortality . However , the adjusted odds ratio increased for each time point . CONCLUSIONS The initial rise of NT-proBNP in NSTEACS is mainly reversible . Factors associated with less reversibility are related to chronically impaired left ventricular function , and factors associated with greater reversibility are related to the acute myocardial damage . The NT-proBNP level measured during a chronic , relatively stable phase is a better predictor of mortality than during an acute unstable phase . The clinical setting and timing of measurement will be important to consider when using NT-proBNP for risk assessment OBJECTIVES We hypothesized that elevated B-type natriuretic peptide ( BNP ) levels would be associated with a greater severity of angiographic disease and a greater extent of myocardium at risk . BACKGROUND Elevations of BNP have been associated with increased risk of adverse outcomes in patients with unstable angina and non-ST-segment elevation myocardial infa rct ion ( UA/NSTEMI ) . METHODS Of the 2,220 patients with UA/NSTEMI enrolled in the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy -Thrombolysis In Myocardial Infa rct ion-18 ( TACTICS-TIMI-18 ) trial , 276 r and omized to the invasive arm had both baseline BNP levels and angiographic core laboratory data . Patients were categorized according to their baseline BNP levels as < or = 80 or > 80 pg/ml . RESULTS A total of 233 patients ( 84 % ) had BNP levels > 80 pg/ml , and 43 ( 16 % ) had admission BNP levels > 80 pg/ml . Patients with BNP > 80 pg/ml had tighter culprit vessel stenosis on quantitative coronary angiography ( median stenosis 76 % vs. 67 % , p = 0.004 ) and a higher ( slower ) corrected TIMI frame count ( median CTFC 43 vs. 30 , p = 0.018 ) in the culprit vessel . The median BNP level was higher in patients with a left anterior descending coronary artery ( LAD ) versus non-LAD culprit lesion location ( median BNP level 40 vs. 24 pg/ml , p = 0.005 ) , and the culprit artery was more often the LAD in patients with BNP > 80 pg/ml compared with < or = 80 pg/ml ( 44 % vs. 30 % , p = 0.06 ) . CONCLUSIONS Among patients with UA/NSTEMI , elevated BNP levels are associated with tighter culprit stenosis , higher CTFC , and LAD involvement . These findings suggest that elevated BNP may be associated with a greater severity and extent of myocardial ischemic territory during the index event and may partly explain the association between elevated BNP and adverse outcomes OBJECTIVES We sought to assess the ability of N-terminal pro-B-type natriuretic peptide ( N-BNP ) to predict vascular events in high-risk people and to test whether statins benefit people with high levels of N-BNP . BACKGROUND The predictive value of N-BNP for occlusive vascular events and the effects of statins in people with high N-BNP levels are uncertain . METHODS A total of 20,536 people were assigned r and omly to simvastatin 40 mg daily or placebo for an average of 5 years . Five baseline N-BNP groups were defined ( < 386 ; 386 to 1,171 ; 1,172 to 2,617 ; 2,618 to 5,758 ; and > or = 5,759 pg/ml ) . RESULTS Baseline N-BNP was strongly predictive of future vascular events independently of other characteristics . Compared with participants with N-BNP < 386 pg/ml , those with levels > or = 5,759 pg/ml had adjusted relative risks for major vascular events ( MVEs ) ( i.e. , major coronary events [ MCE ] [ nonfatal myocardial infa rct ion or coronary death ] , stroke , or revascularization ) of 2.26 , for MCE of 3.09 , for stroke of 1.80 , and for heart failure ( hospitalization or death ) of 9.23 ( all p < 0.0001 ) . Overall , simvastatin allocation reduced the relative risk of MVE by 24 % ( 95 % confidence interval 19 to 28 ) . There was a trend toward smaller ( but still significant ) proportional reductions in MVE among participants with greater baseline N-BNP levels , but the absolute benefits of simvastatin allocation were similar at all N-BNP levels . Simvastatin allocation was also associated with a 14 % ( 95 % confidence interval 0 to 25 ) proportional reduction in heart failure . No excess risk of other vascular and nonvascular outcomes was observed with simvastatin allocation among participants with greater baseline values of N-BNP . CONCLUSIONS In this study , N-BNP levels were strongly predictive not only of heart failure but also of MVEs . In people with high N-BNP levels consistent with heart failure , statin allocation significantly reduced vascular risk , with no evidence of hazard . ( http://www.controlledtrials.com/IS RCT N48489393/48489393 ) BACKGROUND C-reactive protein is an inflammatory marker believed to be of value in the prediction of coronary events . We report data from a large study of C-reactive protein and other circulating inflammatory markers , as well as up date d meta-analyses , to evaluate their relevance to the prediction of coronary heart disease . METHODS Measurements were made in sample s obtained at base line from up to 2459 patients who had a nonfatal myocardial infa rct ion or died of coronary heart disease during the study and from up to 3969 controls without a coronary heart disease event in the Reykjavik prospect i ve study of 18,569 participants . Measurements were made in paired sample s obtained an average of 12 years apart from 379 of these participants in order to quantify within-person fluctuations in inflammatory marker levels . RESULTS The long-term stability of C-reactive protein values ( within-person correlation coefficient , 0.59 ; 95 percent confidence interval , 0.52 to 0.66 ) was similar to that of both blood pressure and total serum cholesterol . After adjustment for base-line values for established risk factors , the odds ratio for coronary heart disease was 1.45 ( 95 percent confidence interval , 1.25 to 1.68 ) in a comparison of participants in the top third of the group with respect to base-line C-reactive protein values with those in the bottom third , and similar overall findings were observed in an up date d meta- analysis involving a total of 7068 patients with coronary heart disease . By comparison , the odds ratios in the Reykjavik Study for coronary heart disease were somewhat weaker for the erythrocyte sedimentation rate ( 1.30 ; 95 percent confidence interval , 1.13 to 1.51 ) and the von Willebr and factor concentration ( 1.11 ; 95 percent confidence interval , 0.97 to 1.27 ) but generally stronger for established risk factors , such as an increased total cholesterol concentration ( 2.35 ; 95 percent confidence interval , 2.03 to 2.74 ) and cigarette smoking ( 1.87 ; 95 percent confidence interval , 1.62 to 2.16 ) . CONCLUSIONS C-reactive protein is a relatively moderate predictor of coronary heart disease . Recommendations regarding its use in predicting the likelihood of coronary heart disease may need to be review ed Aims /hypothesisRaised N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) is associated with a poor cardiac outcome in non-diabetic population s. Elevated NT-proBNP predicts excess morbidity and mortality in diabetic patients with an elevated urinary albumin excretion rate . This study investigated the prognostic value of NT-proBNP in a cohort of type 2 diabetic patients .Subjects , material s and methods In a prospect i ve observational follow-up study , 315 type 2 diabetic patients with normoalbuminuria ( n=188 ) , microalbuminuria ( n=80 ) and macroalbuminuria ( n=47 ) at baseline were followed for a median ( range ) of 15.5 ( 0.2–17.0 ) years . Plasma NT-proBNP concentrations were determined by immunoassay at baseline . Endpoints were overall and cardiovascular mortality . Results Of the patients , 162 died ( 51 % ) , 119 of them ( 74 % ) due to cardiovascular causes . All-cause mortality was increased in patients with NT-proBNP in the second and third tertiles ( hazard ratios [ 95 % CI ] compared with the first tertile , 1.70 [ 1.08–2.67 ] and 5.19 [ 3.43–7.88 ] , p<0.001 ) . These associations persisted after adjustment for urinary albumin excretion rate , glomerular filtration rate and conventional cardiovascular risk factors ( covariate adjusted hazard ratios 1.46 [ 0.91–2.33 ] and 2.54 [ 1.56–4.14 ] , p<0.001 ) . This increased mortality was attributable to more cardiovascular deaths in the second and third NT-proBNP tertile ( unadjusted hazard ratios 1.63 [ 0.96–2.77 ] and 4.88 [ 3.01–7.91 ] , p<0.001 ; covariate adjusted 1.37 [ 0.79–2.37 ] and 2.26 [ 1.27–4.02 ] , p=0.01 ) . When patients with normo- , micro- and macroalbuminuria were analysed separately , NT-proBNP levels above the median ( 62 ng/l ) were consistently associated with increased overall and cardiovascular mortality in all three groups ( p<0.001 ) . Conclusions /interpretationIn patients with type 2 diabetes , elevated circulating NT-proBNP is a strong predictor of the excess overall and cardiovascular mortality , this predictor status being independent of urinary albumin excretion rate and conventional cardiovascular risk factors CONTEXT B-type natriuretic peptides have been shown to predict cardiovascular disease in apparently healthy individuals but their predictive ability for mortality and future cardiovascular events compared with C-reactive protein ( CRP ) and urinary albumin/creatinine ratio is unknown . OBJECTIVE To assess the prognostic value of the N-amino terminal fragment of the prohormone brain natriuretic peptide ( NT-proBNP ) vs CRP and urinary albumin/creatinine ratio in an older adult population . DESIGN , SETTING , AND PARTICIPANTS A population -based prospect i ve study of 764 participants aged 50 to 89 years from a community in Copenhagen , Denmark , in which 658 participants provided blood and urinary sample s and were examined between September 1 , 1998 , and January 24 , 2000 . Of these participants , 626 without heart or renal failure were enrolled . A subgroup of 537 had no history of cardiovascular disease at baseline . During 5 years of follow-up ( to December 31 , 2003 ) , 94 participants died and 65 developed a first major cardiovascular event . MAIN OUTCOME MEASURES Risk of mortality and first major cardiovascular event by baseline levels of NT-proBNP , CRP , and urinary albumin/creatinine ratio levels . RESULTS After adjustment for the cardiovascular risk factors of age , sex , smoking , diabetes mellitus , hypertension or ischemic heart disease , total cholesterol , and serum creatinine , the hazard ratio ( HR ) of mortality for values above the 80th percentile of NT-proBNP was 1.96 ( 95 % confidence interval [ CI ] , 1.21 - 3.19 ) ; for CRP , 1.46 ( 95 % CI , 0.89 - 2.24 ) ; and for urinary albumin/creatinine ratio , 1.88 ( 95 % CI , 1.18 - 2.98 ) . Additional adjustment for left ventricular systolic dysfunction did not markedly attenuate the predictive value of NT-proBNP ( HR , 1.82 ; 95 % CI , 1.11 - 2.98 ) . The absolute unadjusted increase in mortality risk for participants with values above the 80th percentile vs equal to or below the 80th percentile was 24.5 % for NT-proBNP , 7.8 % for CRP , and 19.5 % for urinary albumin/creatinine ratio . The NT-proBNP levels were associated with first major cardiovascular events ( nonfatal myocardial infa rct ion , fatal coronary heart disease , unstable angina , heart failure , stroke , and transient ischemic attack ) with an adjusted HR of 3.24 ( 95 % CI , 1.80 - 5.79 ) vs 1.02 ( 95 % CI , 0.56 - 1.85 ) for CRP and 2.32 ( 95 % CI , 1.33 - 4.05 ) for urinary albumin/creatinine ratio when comparing participants with values above the 80th percentile with those with values equal to or below the 80th percentile . CONCLUSIONS Measurements of NT-proBNP provide prognostic information of mortality and first major cardiovascular events beyond traditional risk factors . NT-proBNP was a stronger risk biomarker for cardiovascular disease and death than CRP was in nonhospitalized individuals aged 50 to 89 years |
1,345 | 29,557,807 | Conclusion : Telmisartan can better improve IR compared with other ARBs | Background : Diabetes mellitus , metabolic syndrome , and other obesity-related diseases are characterized by insulin resistance ( IR ) as a common pathophysiological change and are closely related to cardiovascular disease , which seriously threaten human health .
Telmisartan belongs to a group of drugs called angiotensin II receptor antagonists ( ARBs ) and it can partially activate peroxisome proliferator – activated receptors .
Animal experiments have confirmed that telmisartan can regulate glucose and lipid metabolism , and improve IR .
Study Question : This study performs a systematic review of the advantages of telmisartan in improving IR and compared it with other ARBs . | Few studies have analyzed intraclass differences in angiotensin II receptor blockers ( ARBs ) with respect to antidiabetic or metabolic effects . We design ed a prospect i ve r and omized study to compare a peroxisome proliferator-activated receptor-gamma (PPARgamma)-activating ARB with a nonactivating ARB to delineate the effects on metabolic factors associated with cardiovascular disease . Subjects initially comprised 153 hypertensive patients ( 72 men , 81 women ; mean age , 67.9 + /- 7.8 years ) with diagnosed glucose intolerance on the glucose loading test . Patients were r and omly assigned to receive 6-month administration of telmisartan 47.0 mg/d ( TEL ) or c and esartan 8.4 mg/d ( CAN ) , or to have no change in drug regimen ( control group , CTL ) . Fasting plasma glucose level was significantly reduced in TEL ( n = 46 ) compared with CTL ( n = 47 ) ( percentage of change from baseline , -1.7 % vs + 2.2 % ; P = .045 ) . Percentage of increase in adiponectin was significantly larger in TEL than in CTL ( + 10.5 % vs + 2.2 % , P = .025 ) , but not significantly larger in CAN ( n = 44 ) than in CTL ( + 4.9 % vs + 2.2 % ; P = .13 ) . Percentage of decrease in body weight from baseline was significantly enhanced in TEL compared with CTL ( -2.2 % vs -0.8 % , P = .023 ) and CAN ( -2.2 % vs -0.3 % , P = .007 ) . Telmisartan decreased body weight while increasing serum adiponectin levels in hypertensive patients with glucose intolerance . C and esartan did not achieve similar improvements in these patients . Among ARBs , telmisartan may have a larger impact on obesity-related diseases that can lead to cardiovascular disorders Aim . This study compared the effects of telmisartan and losartan on nonalcoholic fatty liver disease ( NAFLD ) and biochemical markers of insulin resistance in hypertensive NAFLD patients with type 2 diabetes mellitus . Methods . This was a r and omized , open-label , parallel-group comparison of therapy with telmisartan or losartan . Nineteen hypertensive NAFLD patients with type 2 diabetes were r and omly assigned to receive telmisartan at a dose of 20 mg once a day ( n = 12 ) or losartan at a dose of 50 mg once a day ( n = 7 ) for 12 months . Body fat area as determined by CT scanning and hepatic fat content based on the liver-to-spleen ( L/S ) ratio , as well as several parameters of glycemic and lipid metabolism , were compared before and after 12 months . Results . The telmisartan group showed a significant decline in serum free fatty acid ( FFA ) level ( from 0.87 ± 0.26 to 0.59 ± 0.22 mEq/L ( mean ± SD ) , P = 0.005 ) and a significant increase in L/S ratio ( P = 0.049 ) evaluated by CT scan , while these parameters were not changed in the losartan group . Conclusion . Although there was no significant difference in improvement in liver enzymes with telmisartan and losartan treatment in hypertensive NAFLD patients with type 2 diabetes after 12 months , it is suggested that telmisartan may exert beneficial effects by improving fatty liver To examine the effects of telmisartan on peroxisome proliferator – activated receptor γ activation , we compared the effects of telmisartan with those of c and esartan on adipocytokines and glucose and lipid metabolism in vivo and in vitro . In vivo , 56 patients with both type 2 diabetes and hypertension were enrolled and r and omized to receive either telmisartan ( 40 mg ) or c and esartan ( 8 mg ) for 3 months . Serum adiponectin , HbA1c levels , lipid profiles and blood pressure were recorded at the beginning and 3 months later . In vitro , differentiated 3T3-L1 adipocytes were treated with telmisartan , c and esartan , pioglitazone or vehicle for 24 h , and then adiponectin mRNA and protein levels were measured . The results showed that most of the metabolic parameters , including the lipid profiles , did not change significantly during the study in either group . However , the changes in serum adiponectin and plasma glucose over 3 months were significantly greater in the telmisartan group than in the c and esartan group . In vitro , although the protein level of adiponectin was not significantly elevated , the mRNA expression of adiponectin was elevated 1.5-fold by telmisartan in 3T3-L1 adipocytes . Our findings suggest that telmisartan may have beneficial effects in type 2 diabetes beyond its antihypertensive effect OBJECTIVE PPARgamma agonists are widely used in type 2 diabetic patients to reduce insulin resistance . Recently , telmisartan , an AT1 receptor antagonist , was reported to function as a partial agonist of PPARgamma based on in vitro experiments . The aim of the present study was to investigate whether the PPARgamma enhancing activity of telmisartan is exerted clinical ly in diabetic patients . METHODS We compared the effects of telmisartan with those of c and esartan , on insulin sensitivity , the serum levels of various adipocytokines and oxidative stress . PATIENTS In total , 85 Japanese type 2 diabetic patients with hypertension , maintained on 8 mg per day of c and esartan , were r and omly assigned to the TM group ( c and esartan switched to 40 mg of telmisartan , n=38 ) or the CD group ( no treatment change , n=47 ) . RESULTS After 3 months , oxidized lipids were significantly decreased only in the TM group . Although the homeostasis assessment model of insulin resistance ( HOMA-R ) tended to be improved and serum concentrations of HDL-cholesterol and HMW adiponectin tended to be increased only in the TM group , these alterations were too small to be significant by unpaired t-test . Interestingly , in subgroup analysis , the alterations of HOMA-R , serum concentrations of oxidized lipids , and HMW adiponectin were more apparent in obese TM group subjects and the changes reached statistical significance . CONCLUSION Switching from c and esartan to telmisartan in obese subjects increases serum adiponectin and improves both insulin resistance and oxidative stress , while these effects were not statistically apparent in the total patient population . These results support the idea that telmisartan exerts its PPARgamma enhancing activity clinical ly in obese type 2 diabetic patients Background : There is increasing evidence that inhibition of the renin-angiotensin system provides renoprotection independent of blood pressure lowering . The aim of the present study was to determine whether various angiotensin II receptor blockers ( ARBs ) affect urinary albumin excretion ( UAE ) , urinary liver-type fatty acid-binding protein ( L-FABP ) and 8-hydroxy-2′-deoxyguanosine ( 8-OHdG ) levels in early-stage diabetic nephropathy patients with microalbuminuria . Methods : Sixty-eight diabetic nephropathy patients with microalbuminuria were r and omly allocated to 1 of 4 treatment groups : losartan 100 mg/day ( group A ) , c and esartan 12 mg/day ( group B ) , olmesartan 40 mg/day ( group C ) , or telmisartan 80 mg/day ( group D ) . Treatment was continued for 12 months . UAE , L-FABP and 8-OHdG excretion , serum creatinine , and 24-hour creatinine clearance ( Ccr ) were measured . Results : The serum creatinine and 24-hour Ccr were not affected during the experimental period in any of the groups . Systolic and diastolic blood pressures , UAE , urinary L-FABP and 8-OHdG excretion were significantly reduced after 6 and 12 months compared with baseline in any of the groups . ΔL-FABP and Δ8-OHdG were significantly greater in group D than in the other 3 groups after 12 months . Conclusions : ARBs have renoprotection and this effect of telmisartan appears to be more potent than that of losartan , c and esartan , or olmesartan in early-stage diabetic nephropathy patients AIM To evaluate insulin resistance , cytolysis and non-alcoholic steatohepatitis ( NASH ) score ( NAS ) using the Kleiner and Brunt criteria in 54 patients with NASH and mild-to-moderate hypertension , treated with telmisartan vs valsartan for 20 mo . METHODS All patients met the NCEP-ATP III criteria for metabolic syndrome . Histology confirmed steatohepatitis , defined as a NAS greater than five up to 3 wk prior inclusion , using the current criteria . Patients with viral hepatitis , chronic alcohol intake , drug abuse or other significant immune or metabolic hepatic pathology were excluded . Subjects were r and omly assigned either to the valsartan ( V ) group ( st and ard dose 80 mg o.d . , n = 26 ) , or to the telmisartan ( T ) group ( st and ard dose 20 mg o.d . , n = 28 ) . Treatment had to be taken daily at the same hour with no concomitant medication or alcohol consumption allowed . Neither the patient nor the medical staff was aware of treatment group allocation . Paired liver biopsies obtained at inclusion ( visit 1 ) and end of treatment ( EOT ) were assessed by a single blinded pathologist , not aware of patient or treatment group . Blood pressure , BMI , ALT , AST , HOMA-IR , plasma triglycerides ( TG ) and total cholesterol ( TC ) were evaluated at inclusion and every 4 mo until EOT ( visit 6 ) . RESULTS At EOT we noticed a significant decrease in ALT levels vs inclusion in all patients and this decrease did not differ significantly in group T vs group V. HOMA-IR significantly decreased at EOT vs inclusion in all patients but in group T , the mean HOMA-IR decrease per month was higher than in group V. NAS significantly diminished at EOT in all patients with a higher decrease in group T vs group V. CONCLUSION Angiotensin receptor blockers seem to be efficient in hypertension-associated NASH . Telmisartan showed a higher efficacy regarding insulin resistance and histology , perhaps because of its specific PPAR-gamma lig and effect OBJECTIVE To investigate the effects of telmisartan on body fat distribution and insulin sensitivity in patients with hypertension and obesity . METHODS In this prospect i ve , r and omized study , out patients from the Sixth People 's Hospital affiliated to Shanghai Jiaotong University , Shanghai , China were treated with telmisartan ( n=23 ) , or losartan ( n=22 ) for 16 weeks between December 2009 to January 2011 . Parameters such as waist and hip circumference , body mass index , fasting blood glucose , insulin , lipids , serum adiponectin , and tumor necrosis factor-alpha ( TNF-alpha ) were measured before and after treatment . The abdominal visceral fat area ( VFA ) and subcutaneous fat area ( SFA ) were determined by magnetic resonance imaging . Insulin sensitivity was estimated by homeostasis model assessment ( HOMA-IR ) . RESULTS Compared with baseline , the systolic and diastolic blood pressure decreased significantly in both groups . However , the levels of HOMA-IR , serum adiponectin , and TNF-alpha only improved in the telmisartan group . Similarly , the VFA was reduced in the telmisartan group , while the SFA did not change in either group . CONCLUSION Telmisartan improves both hemodynamic and metabolic abnormalities found in hypertensive patients with obesity . The additional benefits may be partly due to visceral fat remodeling Introduction The number of patients with both hypertension and obesity has been increasing in Japan . Many of these patients may also have insulin resistance . Telmisartan , an angiotensin II receptor blocker ( ARB ) , selectively activates peroxisome proliferatoractivated receptor (PPAR)-gamma , and this effect is considered to markedly improve insulin resistance in obese patients with hypertension . We compared the antihypertensive and insulin resistance-improving effects of telmisartan with those of c and esartan and valsartan in this patient population . Methods Twenty-eight elderly patients with an average body mass index ( BMI ) of 27.1 kg/m2 were enrolled in this 6-month study . Patients were r and omly selected to either switch from c and esartan or valsartan to telmisartan or to continue with their current ARB . A 75 g oral glucose tolerance test ( OGTT ) was performed before and after switching , and the effect of telmisartan on the insulin response to glucose loading was investigated . Results There was no significant difference in blood pressure between the two groups after drug administration , but glucose tolerance significantly improved in the telmisartan group . The hyperinsulin response to glucose loading also significantly improved in those taking telmisartan , as well as homeostasis model assessment of insulin resistance ( HOMA-IR ) . These changes were not observed in the control group . Conclusion In patients with hypertension and obesity showing insulin resistance , treatment with telmisartan significantly improved the hyperinsulin response to glucose loading . Telmisartan may therefore be beneficial in these patients Objective Telmisartan is a peroxisome proliferator-activated receptor-γ activator with potent anti-inflammatory and antiatherogenic effects . The authors compared the effects of telmisartan and valsartan on neointima volume , atherosclerosis progression and brachial-ankle pulse wave velocity ( baPWV ) after stenting in hypertensive type 2 diabetes . Design This was a prospect i ve , r and omised , 8-month follow-up study that included patients with significant coronary stenosis who received telmisartan ( n=36 ) or valsartan ( n=37 ) . Setting University hospital . Main outcome measures Neointima volume and atherosclerosis progression 10 mm proximal and distal to the stented segment were analysed using repeat intravascular ultrasonography . baPWV and inflammatory markers such as interleukin 6 , tumour necrosis factor α , C-reactive protein and adiponectin were compared . Results Neointima volume at 8 months was significantly lower in the telmisartan group than the valsartan group ( 1.9±1.0 vs 2.6±1.4 mm3/1 mm , p=0.007 , respectively ) . Total plaque volumes 10 mm proximal ( 7.1±1.5 vs 7.8±1.6 mm3/1 mm , p=0.032 , respectively ) and distal ( 3.5±1.4 vs 4.1±1.3 mm3/1 mm , p=0.028 , respectively ) to the stent were significantly lower in the telmisartan group than the valsartan group at 8 months . The decrease from baseline in baPWV was significantly greater in the telmisartan group than the valsartan group ( −52±104 vs 30±113 cm/s , p=0.002 , respectively ) . The increase from baseline in adiponectin levels and the decreases from baseline in interleukin 6 and tumour necrosis factor α levels were significantly greater in the telmisartan group at 8 months . Retinol-binding protein-4 , homeostasis model of assessment index , hemoglobin A1c and low-density lipoprotein cholesterol levels decreased significantly in both groups without differences in changes from baseline between the two groups . Conclusions Telmisartan reduced neointima volume ; atherosclerosis progression 10 mm proximal and distal to the stented segment and baPWV independent of blood pressure , glucose and lipid control in hypertensive type 2 diabetes . Clinical trial no NCT00599885 ( clinical trials.gov . |
1,346 | 25,439,006 | Conclusion Evidence supports the effectiveness of CCDSS in the care of people with asthma .
However there is very little information of its use in COPD care .
Although there is considerable improvement in the health care process measures and clinical outcomes through the use of CCDSSs , its effects on user workload and efficiency , safety , costs of care , provider and patient satisfaction remain understudied | Background The use of computerized clinical decision support systems may improve the diagnosis and ongoing management of chronic diseases , which requires recurrent visits to multiple health professionals , disease and medication monitoring and modification of patient behavior .
The aim of this review was to systematic ally review r and omized controlled trials evaluating the effectiveness of computerized clinical decision systems ( CCDSS ) in the care of people with asthma and COPD . | BACKGROUND Studies of the use of anti-inflammatory asthma therapy have been limited to selected population s or have been unable to assess the appropriateness of therapy for individuals . OBJECTIVE We sought to describe the current use of asthma medication in the United States population and to examine the influence of symptoms and sociodemographics on medication use . METHODS This study was based on a cross-sectional , national , r and om-digit-dial household telephone survey in 1998 design ed to identify adult patients and parents of children with current asthma . Respondents were classified as having current asthma if they had a physician 's diagnosis of asthma and were either taking medication for asthma or had asthma symptoms during the past year . RESULTS One or more persons met the study criteria for current asthma in 3273 ( 7.8 % ) households in which a screening question naire was completed . Of these , 2509 persons ( 721 children < 16 years ) with current asthma were interviewed . Current use of anti-inflammatory medication was reported by 507 ( 20.1 % ) . Of these , most were using inhaled corticosteroids ( 72.5 % ) , with use of antileukotrienes reported by 11.4 % and use of cromolyn-nedocromil reported by 18.6 % . Of persons with persistent asthma symptoms in the past month , 26.2 % reported current use of some form of anti-inflammatory medication . In bivariate analysis persons reporting lower income , less education , and present unemployment , as well as smokers , were significantly ( P < .001 ) less likely to report current anti-inflammatory use than were other population s. In a multiple regression model nonsmokers and those of white , non-Hispanic ethnicity , as well as persons reporting less asthma control , were more likely to report current anti-inflammatory medication use . CONCLUSION In the United States use of appropriate asthma therapy remains inadequate . Strategies to increase use of anti-inflammatory therapy among patients with asthma are needed . These might include methods to increase access to asthma care for minorities and the socioeconomically disadvantaged Background In patients with prednisone-dependent asthma the dose of oral corticosteroids should be adjusted to the lowest possible level to reduce long-term adverse effects . However , the optimal strategy for tapering oral corticosteroids is unknown . Objective To investigate whether an internet-based management tool including home monitoring of symptoms , lung function and fraction of exhaled nitric oxide ( FENO ) facilitates tapering of oral corticosteroids and leads to reduction of corticosteroid consumption without worsening asthma control or asthma-related quality of life . Methods In a 6-month pragmatic r and omised prospect i ve multicentre study , 95 adults with prednisone-dependent asthma from six pulmonary outpatient clinics were allocated to two tapering strategies : according to conventional treatment ( n=43 ) or guided by a novel internet-based monitoring system ( internet strategy ) ( n=52 ) . Primary outcomes were cumulative sparing of prednisone , asthma control and asthma-related quality of life . Secondary outcomes were forced expiratory volume in 1 s ( FEV1 ) , exacerbations , hospitalisations and patient 's satisfaction with the tapering strategy . Results Median cumulative sparing of prednisone was 205 ( 25–75th percentile −221 to 777 ) mg in the internet strategy group compared with 0 ( −497 to 282 ) mg in the conventional treatment group ( p=0.02 ) . Changes in prednisone dose ( mixed effect regression model ) from baseline were −4.79 mg/day and + 1.59 mg/day , respectively ( p<0.001 ) . Asthma control , asthma-related quality of life , FEV1 , exacerbations , hospitalisations and satisfaction with the strategy were not different between groups . Conclusions An internet-based management tool including home monitoring of symptoms , lung function and FENO in severe asthma is superior to conventional treatment in reducing total corticosteroid consumption without compromising asthma control or asthma-related quality of life . Clinical trial registration number Clinical trial registered with http://www.trialregister.nl ( Netherl and s Trial Register number 1146 ) Background Internet-based self-management has shown to improve asthma control and asthma related quality of life , but the improvements were only marginally clinical ly relevant for the group as a whole . We hypothesized that self-management guided by weekly monitoring of asthma control tailors pharmacological therapy to individual needs and improves asthma control for patients with partly controlled or uncontrolled asthma . Methods In a 1-year r and omised controlled trial involving 200 adults ( 18 - 50 years ) with mild to moderate persistent asthma we evaluated the adherence with weekly monitoring and effect on asthma control and pharmacological treatment of a self-management algorithm based on the Asthma Control Question naire ( ACQ ) . Participants were assigned either to the Internet group ( n = 101 ) that monitored asthma control weekly with the ACQ on the Internet and adjusted treatment using a self-management algorithm supervised by an asthma nurse specialist or to the usual care group ( UC ) ( n = 99 ) . We analysed 3 subgroups : patients with well controlled ( ACQ ≤ 0.75 ) , partly controlled ( 0.75>ACQ ≤ 1.5 ) or uncontrolled ( ACQ>1.5 ) asthma at baseline . Results Overall monitoring adherence was 67 % ( 95 % CI , 60 % to 74 % ) . Improvements in ACQ score after 12 months were -0.14 ( p = 0.23 ) , -0.52 ( p < 0.001 ) and -0.82 ( p < 0.001 ) in the Internet group compared to usual care for patients with well , partly and uncontrolled asthma at baseline , respectively . Daily inhaled corticosteroid dose significantly increased in the Internet group compared to usual care in the first 3 months in patients with uncontrolled asthma ( + 278 μg , p = 0.001 ) , but not in patients with well or partly controlled asthma . After one year there were no differences in daily inhaled corticosteroid use or long-acting β2-agonists between the Internet group and usual care . Conclusions Weekly self-monitoring and subsequent treatment adjustment leads to improved asthma control in patients with partly and uncontrolled asthma at baseline and tailors asthma medication to individual patients ' needs . Trial registration Current Controlled Trials IS RCT OBJECTIVE : Asthma continues to be 1 of the most common chronic diseases of childhood and affects ∼6 million US children . Although National Asthma Education Prevention Program guidelines exist and are widely accepted , previous studies have demonstrated poor clinician adherence across a variety of population s. We sought to determine if clinical decision support ( CDS ) embedded in an electronic health record ( EHR ) would improve clinician adherence to national asthma guidelines in the primary care setting . METHODS : We conducted a prospect i ve cluster-r and omized trial in 12 primary care sites over a 1-year period . Practice s were stratified for analysis according to whether the site was urban or suburban . Children aged 0 to 18 years with persistent asthma were identified by International Classification of Diseases , Ninth Revision codes for asthma . The 6 intervention- practice sites had CDS alerts imbedded in the EHR . Outcomes of interest were the proportion of children with at least 1 prescription for controller medication , an up-to- date asthma care plan , and the performance of office-based spirometry . RESULTS : Increases in the number of prescriptions for controller medications , over time , was 6 % greater ( P = .006 ) and 3 % greater for spirometry ( P = .04 ) in the intervention urban practice s. Filing an up-to- date asthma care plan improved 14 % ( P = .03 ) and spirometry improved 6 % ( P = .003 ) in the suburban practice s with the intervention . CONCLUSION : In our study , using a cluster-r and omized trial design , CDS in the EHR , at the point of care , improved clinician compliance with National Asthma Education Prevention Program guidelines BACKGROUND Although computerized physician order entry reduces medication errors among in patients , little is known about the use of this system in primary care . METHODS We calculated the override rate among 3481 consecutive alerts generated at 5 adult primary care practice s that use a common computerized physician order entry system for prescription writing . For detailed review , we selected a r and om sample of 67 alerts in which physicians did not prescribe an alerted medication and 122 alerts that result ed in a written prescription . We identified factors associated with the physicians ' decisions to override a medication alert , and determined whether an adverse drug event ( ADE ) occurred . RESULTS Physicians overrode 91.2 % of drug allergy and 89.4 % of high-severity drug interaction alerts . In the multivariable analysis using the medical chart review sample ( n = 189 ) , physicians were less likely to prescribe an alerted medication if the prescriber was a house officer ( odds ratio [ OR ] , 0.26 ; 95 % confidence interval [ CI ] , 0.08 - 0.84 ) and if the patient had many drug allergies ( OR , 0.70 ; 95 % CI , 0.53 - 0.93 ) . They were more likely to override alerts for renewals compared with new prescriptions ( OR , 17.74 ; 95 % CI , 5.60 - 56.18 ) . We found no ADEs in cases where physicians observed the alert and 3 ADEs among patients with alert overrides , a nonsignificant difference ( P = .55 ) . Physician review ers judged that 36.5 % of the alerts were inappropriate . CONCLUSIONS Few physicians changed their prescription in response to a drug allergy or interaction alert , and there were few ADEs , suggesting that the threshold for alerting was set too low . Computerized physician order entry systems should suppress alerts for renewals of medication combinations that patients currently tolerate Purpose : Physicians and patients frequently miss opportunities to improve the quality of care of diabetes , primarily because of the complexity of managing many risk factors over many years with many other providers . Electronic decision support is a potential way to improve prescribing and quality of care . Shared care , meaning patients and physicians sharing access to the patient ’s status compared to recommended targets , is thought to improve outcomes as are supportive reminders . Our objective was to rigorously evaluate whether an electronic medical record (EMR)-linked , individualized electronic diabetes tracker with automated telephone reminders could improve the quality of diabetes management in primary care . Methods : Community-based family physicians across Ontario who were already using EMRs in their practice , were recruited . Patient and physician versions of a Web-based diabetes tracker , the ( COMPETE II Diabetes Tracker ( CIIDT ) system , were developed . The main tracker page showed all 13 monitoring variables – the patient ’s recent values , both process ( when last checked ) and outcome ( the result ) , target values for process and outcome , and short advisory messages , with red/yellow/green highlighting to indicate urgency of review . Links to best evidence guidelines and patient re sources were provided . The physician view appeared as an overlay in a corner of their own electronic medical record ( N = 6 EMR products ) . Intervention patients were linked to a voice biometric-enabled automated telephone reminder system ( ATRS ) for medications , labs and visits . Consenting patients with diabetes were r and omized to the CIIDT-ATRS intervention or usual care ( neither ) . Since the study was relatively short ( 6 months follow-up ) , the primary outcome was a composite score of process quality – the quality of monitoring the variables compared to target . Secondary outcomes included clinical outcomes plus evaluations of the tracker and ATRS , and impact on health information privacy . Results : Forty-eight physicians ( mean age ( SD ) = 45.2 ( 10.0 ) , 38.2 % female ) were recruited and 511 patients ( mean age ( SD ) = 60.3 ( 12.4 ) , 49.6 % female , 78 % completed high school ) were r and omized . Only 46.1 % of patients used the Internet at least monthly so print versions of their recent information were sent to them prior to their physician visits . There were frequent technical problems with the Web-based tracker and a lack of data integration between the various EMRs and the tracker . Despite problems , the primary outcome of composite score of physician visits , and checks of blood pressure ( BP ) , LDL cholesterol , HbA1C , microalbuminuria , BMI , feet and eyes , showed a highly statistically significant improvement in the intervention group compared to control ( p<0.0001 ) . There were also highly statistically significant improvements in actual blood pressure ( -2.68 mm diastolic BP , p=0.007 ) and in HbA1C ( -.2 % , p=0.001 ) . 75.9 % of intervention patients were as satisfied or more satisfied with their care since the use of the tracker system and 62.5 % voted to continue to receive ATRS reminders . 22.4 % of patients felt that , in general , the risk of possible loss of confidentiality outweighed the benefits that computers could bring to their health . Over the course of the study , physicians developed a more favourable attitude towards the benefits vs risks of computerized systems in healthcare . Discussion : Despite considerable technical challenges for both patients and physicians , we have demonstrated that the care of a complex chronic disease can be improved with electronic tracking and decision support for both physician and patient . This is one of the first r and omized trial to demonstrate success in routine , community-based primary care . Funding Source : Grant from the Canada Health Infostructure Partnerships Program , Health Canada . References : 1 . Branger PJ . van't Hooft A. van der Wouden JC . Moorman PW . van Bemmel JH . Shared care for diabetes : supporting communication between primary and secondary care . International Journal of Medical Informatics 1999 ; 53:133 - 42 . 2 . Jerant AF . Hill DB . Does the use of electronic medical records improve surrogate patient outcomes in outpatient setting s ? Journal of Family Practice 2000;49:349 - 57 . * Dr Lee is deceased OBJECTIVES To evaluate the effectiveness of an integrated and dynamic electronic decision support system for management of acute asthma in the ED . METHODS A r and omized trial was conducted comparing clinician performance using this electronic interface compared with paper documentation in a simulation scenario . The outcomes were documentation of asthma-related information and consultation times . RESULTS Use of this electronic interface was associated with significantly higher rates of documentation in 7 out of 10 variables , including provision of written short-term asthma management plans . After adjustment for participant seniority , there was no significant difference in consultation times . CONCLUSION In a simulation trial , use of this electronic interface was associated with improvements in clinical and discharge documentation . Further studies are required to test this prototype in clinical practice BACKGROUND The emergence of health information technology provides an opportunity for health care providers to improve the quality and safety of dental care , particularly for patients with medically complex conditions . METHODS The authors r and omized each of 15 dental clinics ( HealthPartners , Bloomington , Minn. ) to one of three groups to evaluate the impact of two clinical decision support ( CDS ) approaches during an 18-month study period . In the first approach -- provider activation through electronic dental records (EDRs)--a flashing alert was generated at the dental visit to identify patients with medically complex conditions and to direct the dental care provider to Web-based personalized care guidelines . In the second approach -- patient activation through personal health records -- a secure e-mail was generated or a letter was mailed to patients before dental visits encouraging them to ask their dental care provider to review the care guidelines specific to their medical conditions . RESULTS The authors evaluated the rate of review ing care guidelines among 102 providers . Participants in the provider and patient activation groups increased their use of the system during the first six months , which had a generalized effect of increasing use of the guidelines for all patients , even if they were not part of the study ( P < .05 ) . The study results showed that provider activation was more effective than was patient activation . However , providers did not sustain their high level of use of the system , and by the end of the study , the rate of use had returned to baseline levels despite participants ' continued receipt of electronic alerts . CONCLUSIONS The study results demonstrated that review of clinical care guidelines for patients with medically complex conditions can be improved with CDS systems that involve the use of electronic health records . CLINICAL IMPLICATION S As the U.S. population ages , dentists must be vigilant in adapting care for patients with medically complex conditions to ensure therapeutic safety and effectiveness . Exp and ed use of CDS via EDRs can help dental care providers achieve this objective Background Patients at risk of severe exacerbations contribute disproportionally to asthma mortality , morbidity and costs . We evaluated the effectiveness and costs of using ‘ asthma risk registers ’ for these patients in primary care . Methods In a cluster-r and omised trial , 29 primary care practice s identified 911 at-risk asthma patients using British asthma guideline criteria ( severe asthma plus adverse psychosocial characteristics ) . Intervention practice s added electronic alerts to identified patients ' records to flag their at-risk status and received practice -based training about using the alerts to improve patient access and opportunistic management . Control practice s continued routine care . Numbers of patients experiencing the primary outcome of a moderate-severe exacerbation ( result ing in death , hospitalisation , accident and emergency attendance , out-of-hours contact , or a course/boost in oral prednisolone for asthma ) , other healthcare and medication usage , and costs over 1 year were derived from practice -based records . Results There was no significant effect on exacerbations ( control : 46.5 % ; intervention : 53.6 % , OR , 95 % CI 1.30 , 0.93 to 1.80 ) . However , this composite outcome masked relative reductions in intervention patients experiencing hospitalisations ( OR 0.50 , 95 % CI 0.26 to 0.94 ) , accident and emergency ( OR 0.74 , 95 % CI 0.42 to 1.31 ) and out-of-hours contacts ( OR 0.79 , 95 % CI 0.45 to 1.37 ) ; and a relative increase in prednisolone prescription for exacerbations ( OR 1.31 , 95 % CI 0.92 to 1.85 ) . Furthermore , prescription of nebulised short-acting β-agonists reduced and long-acting β-agonists increased for intervention relative to control patients . The adjusted mean per patient healthcare cost was £ 138.21 lower ( p=0.837 ) among intervention practice s. Conclusion Using asthma risk registers in primary care did not reduce treated exacerbations , but reduced hospitalisations and increased prescriptions of recommended preventative therapies without increasing costs Information Technology ( IT ) enables health care providers to manage patients with chronic conditions through identification , follow up and administration of specific interventions . In our setting , we developed a surveillance system for chronic diseases . The aim of this study was to show its efficacy on monitoring blood pressure throughout a cluster r and omized controlled trial . Patients without blood pressure registries ( condition 1 ) or with high blood pressure measurements ( condition 2 ) were r and omized to be detected by the surveillance system or to receive usual care . The proportion of patients with at least one blood pressure measurement within three months of follow up was 49.9 % ( 207 patients ) in the intervention group and 37 % ( 195 ) in the control group ( p<0.001 ) for condition 1 . And 61 % ( 224 ) vs. 50 % ( 239 ) respectively ( p=0.002 ) for condition 2 . Patients under the surveillance system have higher proportion of blood pressure measurements , showing this study an improvement on the process of care with this IT tool BACKGROUND Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor . METHODS We recruited 68 primary care family and internal medicine practice s ; 66 were r and omly allocated to a study arm ; 5 practice s withdrew , result ing in 29 receiving the Third Adult Treatment Panel ( ATP III ) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC-7 ) . The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III-recommended treatment . All practice s received copies of each clinical practice guideline , an introductory lecture , 1 performance feedback report , and 4 visits for intervention-specific academic detailing . Data were abstract ed at 61 practice s from r and om sample s of medical records of patients treated from June 1 , 2001 , through May 31 , 2003 ( baseline ) , and from May 1 , 2004 , through April 30 , 2006 ( follow-up ) . The proportion screened with subsequent appropriate decision making ( primary outcome ) was calculated . Generalized estimating equations were used to compare results by arm , accounting for clustering of patients within practice s. RESULTS We examined 5057 baseline and 3821 follow-up medical records . The screening rate for lipid levels increased from 43.6 % to 49.0 % ( ATP III practice s ) and from 40.1 % to 50.8 % ( control practice s ) ( net difference , -5.3 % [ P = .22 ] ) . Appropriate management of lipid levels decreased slightly ( 73.4 % to 72.3 % ) in ATP III practice s and more markedly ( 79.7 % to 68.9 % ) in control practice s. The net change in appropriate management favored the intervention ( + 9.7 % ; 95 % confidence interval [ CI ] , 2.8%-16.6 % [ P < .01 ] ) . Appropriate drug prescription within 4 months decreased in both arms ( 38.8 % to 24.8 % in ATP III practice s and 45.3 % to 24.1 % in control practice s ; net change , + 7.2 % [ P = .37 ] ) Overtreatment declined from 6.6 % to 3.9 % in ATP III and rose from 4.2 % to 6.4 % in control practice s ( net change , -4.9 % [ P = .01 ] ) . CONCLUSIONS A multifactor intervention including personal digital assistant-based decision support may improve primary care physician adherence to the ATP III guidelines . Trial Registration clinical trials.gov Identifier : NCT00224848 BACKGROUND Dyslipidemia remains underdiagnosed and undertreated in patients with coronary artery disease . The Computer-based Clinical Decision Support System provides an opportunity t close these gaps . OBJECTIVES To study the impact of computerized intervention on secondary prevention of CAD . METHODS The CDSS was programmed to automatically detect patients with CAD and to evaluate the availability of an up date d lipoprotein profile and treatment with lipid-lowering drugs . The program produced automatic computer-generated monitoring and treatment recommendations . Adjusted primary clinics were r and omly assigned to intervention ( n=56 ) or st and ard care arms ( n=56 ) . Reminders were mailed to the primary medical teams in the intervention arm every 4 months updating them with current lipid levels and recommendations for further treatment . Compliance and lipid levels were monitored . The study group comprised all patients with CAD who were alive at least 3 months after hospitalization . RESULTS Follow-up was available for 7448 patients ( median 19.8 months , range 6 - 36 months ) . Overall , 51.7 % of patients were adequately screened , and 55.7 % of patients were compliant with treatment to lower lipid level . In patients with initial low density lipoprotein > 120 mg/dl , a significant decrease in LDL levels was observed in both arms , but was more pronounced in the intervention arm : 121.9 + /- 34.2 vs. 124.3 + /- 34.6 mg/dl ( P < 0.02 ) . A significantly lower rate of cardiac rehospitalizations was documented in patients who were adequately treated with lipid-lowering drugs , 37 % vs. 40.9 % ( P < 0.001 ) . CONCLUSIONS This initial assessment of our data represent a real-world snapshot where physicians and CAD patients often do not adhere to clinical guidelines , presenting a major obstacle to implementing effective secondary prevention . Our automatic computerized reminders system substantially facilitates adherence to guidelines and supports wide-range implementation CONTEXT . Barriers impede translating recommendations for asthma treatment into practice , particularly in inner cities where asthma morbidity is highest . METHODS . The purpose of this study was to test the effectiveness of timely patient feedback in the form of a letter providing recent patient-specific symptoms , medication , and health service use combined with guideline -based recommendations for changes in therapy on improving the quality of asthma care by inner-city primary care providers and on result ant asthma morbidity . This was a r and omized , controlled clinical trial in 5- to 11-year-old children ( n = 937 ) with moderate to severe asthma receiving health care in hospital- and community-based clinics and private practice s in 7 inner-city urban areas . The caretaker of each child received a bimonthly telephone call to collect clinical information about the child 's asthma . For a full year , the providers of intervention group children received bimonthly computer-generated letters based on these calls summarizing the child 's asthma symptoms , health service use , and medication use with a corresponding recommendation to step up or step down medications . We measured the number and proportion of scheduled visits result ing in stepping up of medications , asthma symptoms ( 2-week recall ) , and health care use ( 2-month recall ) . RESULTS . In this population , only a modest proportion of children whose symptoms warranted a medication increase actually had a scheduled visit to reevaluate their asthma treatment . However , in the 2-month interval after receipt of a step-up letter , 17.1 % of the letters were followed by scheduled visits in the intervention group compared with scheduled visits 12.3 % of the time by the control children with comparable clinical symptoms . Asthma medications were stepped up when indicated after 46.0 % of these visits in the intervention group compared with 35.6 % in the control group , and when asthma symptoms warranted a step up in therapy , medication changes occurred earlier among the intervention children . Among children whose medications were stepped up at any time during the 12-month study period , those in the intervention group experienced 22.1 % fewer symptom days and 37.9 % fewer school days missed . The intention-to-treat analysis showed no difference over the intervention year in the number of symptom days , yet there was a trend toward fewer days of limited activity and a significant decrease in emergency department visits by the intervention group compared with controls . This 24 % drop in emergency department visits result ed in an intervention that was cost saving in its first year . CONCLUSIONS . Patient-specific feedback to inner-city providers increased scheduled asthma visits , increased asthma visits in which medications were stepped up when clinical ly indicated , and reduced emergency department visits The present study assessed the impact of computerised spirometry interpretation expert support on the diagnostic achievements of general practitioners ( GPs ) , and on GPs ' decision making in diagnosing chronic respiratory disease . A cluster-r and omised controlled trial was performed in 78 GPs who each completed 10 st and ardised paper case descriptions . Intervention consisted of support for GPs ' spirometry interpretation either by an expert system ( expert support group ) or by sham information ( control group ) . Agreement of GPs ' diagnoses was compared with an expert panel judgement , which served as the primary outcome . Secondary outcomes were : additional diagnostic test rates ; width of differential diagnosis ; certainty of diagnosis ; estimated severity of disease ; referral rate ; and medication or nonmedication changes . Effects were expressed as odds ratios ( ORs ) with 95 % confidence intervals ( CIs ) . There were no differences between the expert support and control groups in the agreement between GPs and expert panel diagnosis of chronic obstructive pulmonary disease ( OR ( 95 % CI ) 1.08 ( 0.70–1.66 ) ) , asthma ( 1.13 ( 0.70–1.80 ) ) , and absence of respiratory disease ( 1.32 ( 0.61–2.86 ) ) . A higher rate of additional diagnostic tests was observed in the expert support group ( 2.5 ( 1.17–5.35 ) ) . Computerised spirometry expert support had no detectable benefit on general practitioners ' diagnostic achievements and the decision-making process when diagnosing chronic respiratory disease OBJECTIVE We developed AsthmaCritic , a non-inquisitive critiquing system integrated with the general practitioners ' electronic medical records . The system is based on the guidelines for asthma and chronic obstructive pulmonary disease ( COPD ) as issued by the Dutch College of General Practitioners . This paper assesses the effect of AsthmaCritic on monitoring and treatment of asthma and COPD by Dutch general practitioners in daily practice . METHODS A r and omized clinical trial in 32 practice s ( 40 Dutch general practitioners ) using electronic patient records . An intervention group was given the use of AsthmaCritic , a control group continued working in the usual manner . Both groups had the disposal of the asthma and COPD guidelines routinely distributed by the Dutch College of General Practitioners . We measured the average number of contacts , FEV 1 ( forced expiratory volume ) , and peak-flow measurements per asthma/ COPD patient per practice ; and , the average number of antihistamine , cromoglycate , deptropine , and oral bronchodilator prescriptions per asthma/ COPD patient per practice . RESULTS The number of contacts increased in the age group of 12 - 39 years . The number of FEV1 , peak-flow measurements , and the ratio of coded measurements increased , whereas the number of cromoglycate prescriptions decreased in the age group of 12 - 39 years . CONCLUSIONS Our study shows that the guideline -based critiquing system AsthmaCritic changed the manner in which the physicians monitored their patients and , to a lesser extent , their treatment behavior . In addition , the physicians changed their data -recording habits Background : Diabetes mellitus is a complex disease with serious complications . Electronic decision support , providing information that is shared and discussed by both patient and physician , encourages timely interventions and may improve the management of this chronic disease . However , it has rarely been tested in community-based primary care . Methods : In this pragmatic r and omized trial , we r and omly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care . The intervention involved shared access by the primary care provider and the patient to a Web-based , colour-coded diabetes tracker , which provided sequential monitoring values for 13 diabetes risk factors , their respective targets and brief , prioritized messages of advice . The primary outcome measure was a process composite score . Secondary outcomes included clinical composite scores , quality of life , continuity of care and usability . The outcome assessors were blinded to each patient ’s intervention status . Results : We recruited sequentially 46 primary care providers and then 511 of their patients ( mean age 60.7 [ st and ard deviation 12.5 ] years ) . Mean follow-up was 5.9 months . The process composite score was significantly better for patients in the intervention group than for control patients ( difference 1.27 , 95 % confidence interval [ CI ] 0.79–1.75 , p < 0.001 ) ; 61.7 % ( 156/253 ) of patients in the intervention group , compared with 42.6 % ( 110/258 ) of control patients , showed improvement ( difference 19.1 % , p < 0.001 ) . The clinical composite score also had significantly more variables with improvement for the intervention group ( 0.59 , 95 % CI 0.09–1.10 , p = 0.02 ) , including significantly greater declines in blood pressure ( −3.95 mm Hg systolic and −2.38 mm Hg diastolic ) and glycated hemoglobin ( −0.2 % ) . Patients in the intervention group reported greater satisfaction with their diabetes care . Interpretation : A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care . ( Clinical Trials.gov trial register no. NCT00813085 . OBJECTIVE It is difficult to control drug-prescribing behaviour in general practice , despite the development and distribution of guidelines . The purpose of this study was to assess the effect on drug-prescribing behaviour of implementing prescribing guidelines by means of a reactive computer reminder system ( CRS ) . DESIGN Cluster-r and omised controlled trial with an incomplete block design in the south of the Netherl and s : 25 GPs ( 7 GP practice s ) received reminders about antibiotics and asthma/ COPD prescriptions , 28 GPs ( 7 GP practice s ) received reminders about cholesterol prescriptions . Prescription guidelines were integrated into the computerised GP information system . MEASUREMENTS Both performance indicators and prescription volumes were calculated as the main outcome measures . Next to individual volume measure , sum scores were constructed on the volume measures per drug group ( antibiotics , asthma/ COPD and cholesterol ) . RESULTS Variation between GPs turned out to be larger and more skewed than expected . No differences between groups were found for indicators and volumes related to recommendations advocating certain drugs . Although there was a tendency towards clinical ly relevant results for prescription volumes that were supposed to drop , the difference in sum score between the groups was not significant . For antibiotic prescriptions that were supposed to drop , the sum score for the intervention group was 28.2 ( 95 % CI : 20.8 - 44.5 ) prescriptions per 1000 patients per GP , while this was 39.7 ( 95 % CI : 29.7 - 64.1 ) for the control group ( p 0.2 ) . For prescriptions asthma/ COPD that were supposed to drop , the sum score for the intervention group was 1.1 ( 95 % CI : 0.6 - 2.6 ) prescriptions per 1000 patients per GP , while this was 2.2 ( 95 % CI : 1.4 - 4.3 ) for the control group ( p 0.1 ) . On three specific recommendations ( on quinolones for cystitis , corticosteroids for CPOD , and antibiotics for acute sore throat ) significant differences were found . CONCLUSIONS This study turned out to be underpowered due to high inter doctor variation in prescribing behaviour . Nevertheless , computerised reminders sometimes have a favourable effect on restricting certain drugs that are not or no longer indicated in general practice BACKGROUND The extent to which patients with obstructive lung disease receive recommended processes of care is largely unknown . We assessed the quality of care delivered to a national sample of the US population . METHODS We extracted medical records for 2 prior years from consenting participants in a r and om telephone survey in 12 communities and measured the quality of care provided with 45 explicit , process-based quality indicators for asthma and COPD developed using the modified Delphi expert panel methodology . Multivariate logistic regression evaluated effects of patient demographics , insurance , and other characteristics on the quality of health care . RESULTS We identified 2,394 care events among 260 asthma participants and 1,664 events among 169 COPD participants . Overall , participants received 55.2 % of recommended care for obstructive lung disease . Asthma patients received 53.5 % of recommended care ; routine management was better ( 66.9 % ) than exacerbation care ( 47.8 % ) . COPD patients received 58.0 % of recommended care but received better exacerbation care ( 60.4 % ) than routine care ( 46.1 % ) . Variation was seen in mode of care with considerable deficits in documenting recommended aspects of medical history ( 41.4 % ) and use of diagnostic studies ( 40.1 % ) . Modeling demonstrated modest variation between racial groups , geographic areas , insurance types , and other characteristics . CONCLUSIONS Americans with obstructive lung disease received only 55 % of recommended care . The deficits and variability in the quality of care for obstructive lung disease present ample opportunity for quality improvement . Future endeavors should assess reasons for low adherence to recommended processes of care and assess barriers in delivery of care BACKGROUND Experience from other fields of internal medicine shows that Internet-based technology can be used to monitor various diseases . The new technology h and les complex calculation programs easily , and it is a unique way of communicating . These advantages might be used in optimizing the treatment for asthmatic subjects because undertreatment is a common problem found in European asthmatic subjects . OBJECTIVE We sought to investigate the outcome of monitoring and treatment using a physician-managed online interactive asthma monitoring tool and to assess whether the outcome differs from that of monitoring and treatment in an outpatient respiratory clinic or in primary care . METHODS Three hundred asthmatic subjects were r and omized to 3 parallel groups in a 6-month prospect i ve study : ( 1 ) Internet-based monitoring ( n = 100 ) ; ( 2 ) specialist monitoring ( n = 100 ) ; and ( 3 ) general practitioner ( GP ) monitoring ( n = 100 ) . All the patients were examined on entry into the study and after 6 months of treatment . RESULTS The treatment and monitoring with the Internet-based management tool lead to significantly better improvement in the Internet group than in the other 2 groups regarding asthma symptoms ( Internet vs specialist : odds ratio of 2.64 , P = .002 ; Internet vs GP : odds ratio of 3.26 ; P < .001 ) , quality of life ( Internet vs specialist : odds ratio of 2.21 , P = .03 ; Internet vs GP : odds ratio of 2.10 , P = .04 ) , lung function ( Internet vs specialist : odds ratio of 3.26 , P = .002 ; Internet vs GP : odds ratio of 4.86 , P < .001 ) , and airway responsiveness ( Internet vs GP : odds ratio of 3.06 , P = .02 ) . CONCLUSION When physicians and patients used an interactive Internet-based asthma monitoring tool , better asthma control was achieved BACKGROUND We conducted a cluster r and omized controlled trial to examine the effectiveness of computerized decision support ( CDS ) design ed to improve hypertension care and outcomes in a racially diverse sample of primary care patients . METHODS We r and omized 2,027 adult patients receiving hypertension care in 14 primary care practice s to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group . We assessed prescribing of guideline -recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients ’ race/ethnicity using interaction terms . MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42 % at baseline and 46 % at the outcome visit with no significant differences between groups . After adjustment for patients ’ demographic and clinical characteristics , number of prior visits , and levels of baseline blood pressure control , there were no differences between intervention groups in the odds of outcome blood pressure control . The use of CDS to providers significantly improved Joint National Committee ( JNC ) guideline adherent medication prescribing compared to usual care ( 7 % versus 5 % , P < 0.001 ) ; the effects of the intervention remained after multivariable adjustment ( odds ratio [ OR ] 1.39 [ CI , 1.13–1.72 ] ) and the effects of the intervention did not differ by patients ’ race and ethnicity . CONCLUSIONS CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control . Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed OBJECTIVE Translation of evidence -based guidelines into clinical practice has been inconsistent . We performed a r and omized , controlled trial of guideline -based care suggestions delivered to physicians when writing orders on computer workstations . STUDY SETTING Inner-city academic general internal medicine practice . STUDY DESIGN R and omized , controlled trial of 246 physicians ( 25 percent faculty general internists , 75 percent internal medicine residents ) and 20 outpatient pharmacists . We enrolled 706 of their primary care patients with asthma or chronic obstructive pulmonary disease . Care suggestions concerning drugs and monitoring were delivered to a r and om half of the physicians and pharmacists when writing orders or filling prescriptions using computer workstations . A 2 x 2 factorial r and omization of practice sessions and pharmacists result ed in four groups of patients : physician intervention , pharmacist intervention , both interventions , and controls . DATA EXTRACTION / COLLECTION METHODS : Adherence to the guidelines and clinical activity was assessed using patients ' electronic medical records . Health-related quality of life , medication adherence , and satisfaction with care were assessed using telephone question naires . PRINCIPAL FINDINGS During their year in the study , patients made an average of five scheduled primary care visits . There were no differences between groups in adherence to the care suggestions , generic or condition-specific quality of life , satisfaction with physicians or pharmacists , medication compliance , emergency department visits , or hospitalizations . Physicians receiving the intervention had significantly higher total health care costs . Physician attitudes toward guidelines were mixed . CONCLUSIONS Care suggestions shown to physicians and pharmacists on computer workstations had no effect on the delivery or outcomes of care for patients with reactive airways disease OBJECTIVE : The goal was to assess the impact of influenza vaccine clinical alerts on missed opportunities for vaccination and on overall influenza immunization rates for children and adolescents with asthma . METHODS : A prospect i ve , cluster-r and omized trial of 20 primary care sites was conducted between October 1 , 2006 , and March 31 , 2007 . At intervention sites , electronic health record-based clinical alerts for influenza vaccine appeared at all office visits for children between 5 and 19 years of age with asthma who were due for vaccine . The proportion of captured immunization opportunities at visits and overall rates of complete vaccination for patients at intervention and control sites were compared with those for the previous year , after st and ardization for relevant covariates . The study had > 80 % power to detect an 8 % difference in the change in rates between the study and baseline years at intervention versus control practice s. RESULTS : A total of 23 418 visits and 11 919 children were included in the study year and 21 422 visits and 10 667 children in the previous year . The majority of children were male , 5 to 9 years of age , and privately insured . With st and ardization for selected covariates , captured vaccination opportunities increased from 14.4 % to 18.6 % at intervention sites and from 12.7 % to 16.3 % at control sites , a 0.6 % greater improvement . St and ardized influenza vaccination rates improved 3.4 % more at intervention sites than at control sites . The 4 practice s with the greatest increases in rates ( ≥11 % ) were all in the intervention group . Vaccine receipt was more common among children who had been vaccinated previously , with increasing numbers of visits , with care early in the season , and at preventive versus acute care visits . CONCLUSIONS : Clinical alerts were associated with only modest improvements in influenza vaccination rates Context Patient self-management is an essential component of asthma care , and the Internet is a medium to potentially support patients in self-management . Contribution This r and omized trial compared Internet-based asthma self-management with usual care and found modest improvements in asthma control and lung function with the Internet intervention , but found no reduction in exacerbations and changes in asthma-related quality of life that were less than clinical ly significant at 12 months . Implication Although Internet-based self management can improve some asthma outcomes , the improvements were small and the program did not reduce the number of exacerbations . The Editors Asthma is a chronic disorder of the airways that is characterized by recurring respiratory symptoms , variable airflow obstruction , airway hyperresponsiveness , and underlying inflammation ( 1 , 2 ) . Recent clinical guidelines for the management of asthma distinguish 4 essential components of asthma care : assessment and monitoring , patient education , control of environmental and comorbid factors that affect asthma , and drug treatment . With appropriate medical care , well-informed and empowered patients can control their asthma and live full , active lives ( 1 , 2 ) . However , despite the availability of monitoring tools and effective therapy , asthma control is suboptimal in many patients worldwide , and long-term management falls far short of the goals set in the guidelines ( 3 ) . Self-monitoring , education , and specific medical care are important aspects in improving the lives of patients with asthma ( 1 , 2 ) . However , many patients with mild or moderate persistent asthma do not attend checkups regularly or visit their physician with symptoms of the disease ( 4 ) . In addition , in practice , both patients and their health care providers are reluctant to use written self-management plans ( 5 ) . Internet technology is increasingly seen as an appealing tool to support self-management for patients with chronic disease in remote and underserved population s ( 68 ) . However , to date , studies on Internet-based asthma self-management show only short-term improvements in asthma control , lung function , and quality of life ( 911 ) . Long-term studies on the effect of Internet-based self-management , including all its essential features , are not available . Therefore , we developed a guided self-management tool for adult patients with asthma that included Internet-based home monitoring and treatment advice ( action plan ) , online education , and remote Web communication with a specialized asthma nurse . The goal of our study was to assess the long-term clinical effectiveness of Internet-based self-management education compared with usual physician-provided care alone . Methods Design Overview We conducted a 12-month , multicenter , nonblinded , r and omized , controlled trial . We r and omly assigned patients to Internet-based self-management ( Internet group ) as an adjunct to usual care or to usual physician-provided care alone ( usual care group ) . The Internet-based self-management program included weekly asthma control monitoring and treatment advice , online and group education , and remote Web communications with a specialized asthma nurse . The intervention continued for 12 months after enrollment . The Medical Ethics Committee of the Leiden University Medical Center , Leiden , the Netherl and s , approved the study . Setting and Participants We recruited patients from 37 general practice s ( 69 general practitioners ) in the Leiden and The Hague area and the Outpatient Clinic of the Department of Pulmonology at the Leiden University Medical Center from September 2005 to September 2006 . Inclusion criteria were physician-diagnosed asthma coded according to the International Classification of Primary Care in the electronic medical record ( 12 ) , age 18 to 50 years , prescription of inhaled corticosteroids for at least 3 months in the previous year , no serious comorbid conditions that interfered with asthma treatment , access to the Internet at home , and mastery of the Dutch language . We excluded patients who were receiving maintenance oral glucocorticosteroid treatment . On the basis of diagnosis , age , prescribed asthma medication , and comorbid conditions , we sent eligible patients an invitation letter followed by 1 reminder letter after 2 to 4 weeks if they did not respond to the first . We continued this process until a total of 200 patients had entered the study ( September 2006 ) . All participants gave written consent . R and omization and Intervention In a 2-week baseline period before r and omization , we collected data on patient demographic characteristics , asthma-related quality of life , symptom control , lung function , and medication level . We provided basic education about core information on asthma , action of medications , and inhaler technique instructions to all patients . We trained all participants to measure FEV1 daily with a h and -held electronic spirometer ( PiKo-1 , Ferraris Respiratory , Hertford , United Kingdom ) and to report the highest value of 3 measurements in the morning before taking medication ( 2 , 13 ) . They were shown how to report these values on a personal page on a secure Web application by using a login password ( or how to report by mobile telephone text message ) . Patients were also asked to report their nighttime and daytime asthma symptom scores on this Internet page or by text message . We asked all participants to complete the Asthma Control Question naire on their personal Internet page each week ( 14 ) . We did not give any patients feedback about lung function or asthma control . After the 2-week baseline period , we r and omly assigned participants to either the Internet group or the usual care group . We stratified according to care provider ( primary vs. subspecialty care ) and asthma control at baseline ( 15 ) . We r and omly assigned patients to the 2 groups ( 1:1 ratio ) by using a computer-generated , permuted-block scheme . Allocation took place by computer after collection of the baseline data , ensuring concealment of allocation . The Internet-based self-management program consisted of the 4 principal components of asthma self-management and was accessed through the specially design ed Web site , which allowed monitoring through the Web site ( or text message on a mobile telephone ) , use of an Internet-based treatment plan , online education , and Web communications with a specialized asthma nurse ( 16 ) . Patients monitored their asthma weekly by completing an electronic version of the Asthma Control Question naire on the Web site and instantly received feedback on the current state of their asthma control along with advice on how to adjust their treatment according to a predefined algorithm and treatment plan ( Table 1 and Appendix Figures 1 , 2 , 3 , 4 , and 5 ) . Depending on the scores su bmi tted , patients received 4 types of self-treatment advice . When 4 consecutive Asthma Control Question naire scores were 0.5 or less , patients were advised to decrease treatment according to treatment plan . When 2 consecutive scores were greater than 0.5 but less than 1.0 , patients were advised to increase treatment according to treatment plan . When 1 score was 1.0 or more but less than 1.5 , patients were advised to immediately increase treatment according to treatment plan . Finally , when 1 score was 1.5 or more , patients were advised to immediately increase treatment and contact the asthma nurse . Table 1 . Treatment Plan Appendix Figure 1 . Algorithm based on consecutive ACQ scores to adjust medical treatment . * ACQ = Asthma Control Question naire . At entry of the algorithm , the evaluation period is bypassed . The evaluation period starts after treatment was stepped up . The optimal control period starts after 1 ACQ score 0.5 and ends after 1 ACQ score > 0.5 . Appendix Figure 2 . Screen shot of daily lung function and symptom monitoring . Appendix Figure 3 . Screen shot of feedback on daily lung function and symptom monitoring . Appendix Figure 4 . Screen shot of weekly Asthma Control Question naire monitoring . Appendix Figure 5 . Screen shot of feedback on Asthma Control Question naire , treatment advice according to personalized treatment plan , and results of past 6 months . We advised no medication changes during the 4 weeks after treatment was stepped up ( evaluation period ) . In addition to weekly assessment s , patients could optionally report daily symptoms and lung function and were able to contact our asthma nurse though the Web or by telephone . Thus , any acute deterioration warranting a visit to the general practitioner or hospital could be detected ( Appendix Figures 2 and 3 ) . We aim ed to empower patients to use the Internet-based self-management tool and to develop a patientprovider partnership in asthma care ( 2 ) . Self-management education consisted of both Web-based and face-to-face , group-based education . Web-based education included asthma information , news , frequently asked questions , and interactive communication with a respiratory nurse specialist . We scheduled 2 group-based education sessions , which lasted 45 to 60 minutes , for patients in the Internet-based self-management group within 6 weeks after entering the trial . Both sessions included exploration of a patient 's interests and previous knowledge ( negotiating an agenda and patient-centered education ) , personalized feedback , and empowerment of self-management ( self-efficacy and implementing a plan for change ) ( 2 , 17 ) . The first educational session also included pathophysiology of asthma , information on the Web-based action plan , and information and review of inhalation technique . The second educational session gave information about the mechanisms and side effects of medication and explained trigger avoidance . Patients in the usual care group received asthma care according to the Dutch general practice guidelines on asthma management in adults , which recommend a medical review and treatment adjustment every 2 to 4 weeks in unstable asthma and medical review once or twice INTRODUCTION Pediatric asthma exacerbations account for > 1.8 million emergency department ( ED ) visits annually . Asthma guidelines are intended to guide time-dependent treatment decisions that improve clinical outcomes ; however , guideline adherence is inadequate . We examined whether an automatic disease detection system increases clinicians ' use of paper-based guidelines and decreases time to a disposition decision . METHODS We evaluated a computerized asthma detection system that triggered NHLBI-adopted , evidence -based practice to improve care in an urban , tertiary care pediatric ED in a 3-month ( 7/09 - 9/09 ) prospect i ve , r and omized controlled trial . A probabilistic system screened all ED patients for acute asthma . For intervention patients , the system generated the asthma protocol at triage for intervention patients to guide early treatment initiation , while clinicians followed st and ard processes for control patients . The primary outcome measures included time to patient disposition . RESULTS The system identified 1100 patients with asthma exacerbations , of which 704 had a final asthma diagnosis determined by a physician-established reference st and ard . The positive predictive value for the probabilistic system was 65 % . The median time to disposition decision did not differ among the intervention ( 289 min ; IQR = ( 184 , 375 ) ) and control group ( 288 min ; IQR = ( 185 , 375 ) ) ( p=0.21 ) . The hospital admission rate was unchanged between intervention ( 37 % ) and control groups ( 35 % ) ( p = 0.545 ) . ED length of stay did not differ among the intervention ( 331 min ; IQR = ( 226 , 581 ) ) and control group ( 331 min ; IQR = ( 222 , 516 ) ) ( p = 0.568 ) . CONCLUSION Despite a high level of support from the ED leadership and staff , a focused education effort , and implementation of an automated disease detection , the use of the paper-based asthma protocol remained low and time to patient disposition did not change AIM To assess the impact of two modes of spirometry expert support on Family physicians ' ( FPs ' ) diagnoses and planned management in patients with apparent respiratory disease . METHOD A cluster-r and omised trial was performed with family practice s as the unit of r and omisation . FPs from 44 family practice s recorded their diagnosis and planned management before and after spirometry for 868 patients . Intervention consisted of spirometry interpretation support by either a chest physician or expert software . Both interventions were compared with usual care ( i.e. no additional interpretation support ) . Change in FPs ' diagnoses after spirometry served as the primary outcome . Secondary outcomes were referral rate , additional diagnostic tests , and disease management changes . Effects were expressed as percentages and Odds Ratios ( OR ) with 95 % confidence intervals . RESULTS Diagnoses changed after intervention in all groups : 47.8 % ( 95 % CI 41.8 to 53.9 ) for chest physician support ; 45.0 % ( 95 % CI 39.5 to 50.6 ) for software support ; and 53.3 % ( 95 % CI 47.2 to 59.4 ) for usual care . Differences in the proportions of changed diagnosis were not statistically significant : chest physician support versus usual care OR 0.79 ( 95%CI 0.49 to 1.30 ) ; software support versus usual care OR 0.72 ( 95 % CI 0.45 - 1.15 ) . There were no differences in secondary outcomes . CONCLUSION Neither chest physician spirometry support nor expert software spirometry support had a significant impact on FPs ' diagnosis of respiratory conditions or management decisions . TRIAL NUMBER http://www . clinical trials.gov/ct/show/NCT00131157?order=1 |
1,347 | 28,259,301 | antiangiogenic drugs did not improve overall survival in glioblastoma patients , either as first or second-line treatment , and either as single agent or in combination with chemotherapy .
Among antiangiogenic drugs , only bevacizumab improved progression-free survival regardless of treatment line , both as single agent or in combination with chemotherapy | BACKGROUND glioblastomas are highly vascularized tumors and various antiangiogenic drugs have been investigated in clinical trials showing unclear results .
We performed a systematic review and a meta- analysis to clarify and evaluate their effectiveness in glioblastoma patients . | Treatment of glioblastoma ( GBM ) , the most common primary malignant brain tumor in adults , remains a significant unmet need in oncology . Historically , cytotoxic treatments provided little durable benefit , and tumors recurred within several months . This has spurred a substantial research effort to establish more effective therapies for both newly diagnosed and recurrent GBM . In this context , antiangiogenic therapy emerged as a promising treatment strategy because GBMs are highly vascular tumors . In particular , GBMs overexpress vascular endothelial growth factor ( VEGF ) , a proangiogenic cytokine . Indeed , many studies have demonstrated promising radiographic response rates , delayed tumor progression , and a relatively safe profile for anti-VEGF agents . However , r and omized phase III trials conducted to date have failed to show an overall survival benefit for antiangiogenic agents alone or in combination with chemoradiotherapy . These results indicate that antiangiogenic agents may not be beneficial in unselected population s of patients with GBM . Unfortunately , biomarker development has lagged behind in the process of drug development , and no vali date d biomarker exists for patient stratification . However , hypothesis-generating data from phase II trials that reveal an association between increased perfusion and /or oxygenation ( ie , consequences of vascular normalization ) and survival suggest that early imaging biomarkers could help identify the subset of patients who most likely will benefit from anti-VEGF agents . In this article , we discuss the lessons learned from the trials conducted to date and how we could potentially use recent advances in GBM biology and imaging to improve outcomes of patients with GBM who receive antiangiogenic therapy BACKGROUND Treatment options for recurrent glioblastoma are scarce , with second-line chemotherapy showing only modest activity against the tumour . Despite the absence of well controlled trials , bevacizumab is widely used in the treatment of recurrent glioblastoma . Nonetheless , whether the high response rates reported after treatment with this drug translate into an overall survival benefit remains unclear . We report the results of the first r and omised controlled phase 2 trial of bevacizumab in recurrent glioblastoma . METHODS The BELOB trial was an open-label , three-group , multicentre phase 2 study undertaken in 14 hospitals in the Netherl and s. Adult patients ( ≥18 years of age ) with a first recurrence of a glioblastoma after temozolomide chemoradiotherapy were r and omly allocated by a web-based program to treatment with oral lomustine 110 mg/m(2 ) once every 6 weeks , intravenous bevacizumab 10 mg/kg once every 2 weeks , or combination treatment with lomustine 110 mg/m(2 ) every 6 weeks and bevacizumab 10 mg/kg every 2 weeks . R and omisation of patients was stratified with a minimisation procedure , in which the stratification factors were centre , Eastern Cooperative Oncology Group performance status , and age . The primary outcome was overall survival at 9 months , analysed by intention to treat . A safety analysis was planned after the first ten patients completed two cycles of 6 weeks in the combination treatment group . This trial is registered with the Nederl and s Trial Register ( www.trialregister.nl , number NTR1929 ) . FINDINGS Between Dec 11 , 2009 , and Nov 10 , 2011 , 153 patients were enrolled . The preplanned safety analysis was done after eight patients had been treated , because of haematological adverse events ( three patients had grade 3 thrombocytopenia and two had grade 4 thrombocytopenia ) which reduced bevacizumab dose intensity ; the lomustine dose in the combination treatment group was thereafter reduced to 90 mg/m(2 ) . Thus , in addition to the eight patients who were r and omly assigned to receive bevacizumab plus lomustine 110 mg/m(2 ) , 51 patients were assigned to receive bevacizumab alone , 47 to receive lomustine alone , and 47 to receive bevacizumab plus lomustine 90 mg/m(2 ) . Of these patients , 50 in the bevacizumab alone group , 46 in the lomustine alone group , and 44 in the bevacizumab and lomustine 90 mg/m(2 ) group were eligible for analyses . 9-month overall survival was 43 % ( 95 % CI 29 - 57 ) in the lomustine group , 38 % ( 25 - 51 ) in the bevacizumab group , 59 % ( 43 - 72 ) in the bevacizumab and lomustine 90 mg/m(2 ) group , 87 % ( 39 - 98 ) in the bevacizumab and lomustine 110 mg/m(2 ) group , and 63 % ( 49 - 75 ) for the combined bevacizumab and lomustine groups . After the reduction in lomustine dose in the combination group , the combined treatment was well tolerated . The most frequent grade 3 or worse toxicities were hypertension ( 13 [ 26 % ] of 50 patients in the bevacizumab group , three [ 7 % ] of 46 in the lomustine group , and 11 [ 25 % ] of 44 in the bevacizumab and lomustine 90 mg/m(2 ) group ) , fatigue ( two [ 4 % ] , four [ 9 % ] , and eight [ 18 % ] ) , and infections ( three [ 6 % ] , two [ 4 % ] , and five [ 11 % ] ) . At the time of this analysis , 144/148 ( 97 % ) of patients had died and three ( 2 % ) were still on treatment . INTERPRETATION The combination of bevacizumab and lomustine met prespecified criteria for assessment of this treatment in further phase 3 studies . However , the results in the bevacizumab alone group do not justify further studies of this treatment . FUNDING Roche Nederl and and KWF Kankerbestrijding Significance This study demonstrates that antiangiogenic therapy increases tumor blood perfusion in a subset of newly diagnosed glioblastoma patients , and that it is these patients who survive longer when this expensive and potentially toxic therapy is combined with st and ard radiation and chemotherapy . This study provides fresh insights into the selection of glioblastoma patients most likely to benefit from antiangiogenic treatments . Antiangiogenic therapy has shown clear activity and improved survival benefit for certain tumor types . However , an incomplete underst and ing of the mechanisms of action of antiangiogenic agents has hindered optimization and broader application of this new therapeutic modality . In particular , the impact of antiangiogenic therapy on tumor blood flow and oxygenation status ( i.e. , the role of vessel pruning versus normalization ) remains controversial . This controversy has become critical as multiple phase III trials of anti-VEGF agents combined with cytotoxics failed to show overall survival benefit in newly diagnosed glioblastoma ( nGBM ) patients and several other cancers . Here , we shed light on mechanisms of nGBM response to cediranib , a pan-VEGF receptor tyrosine kinase inhibitor , using MRI techniques and blood biomarkers in prospect i ve phase II clinical trials of cediranib with chemoradiation vs. chemoradiation alone in nGBM patients . We demonstrate that improved perfusion occurs only in a subset of patients in cediranib-containing regimens , and is associated with improved overall survival in these nGBM patients . Moreover , an increase in perfusion is associated with improved tumor oxygenation status as well as with pharmacodynamic biomarkers , such as changes in plasma placenta growth factor and sVEGFR2 . Finally , treatment resistance was associated with elevated plasma IL-8 and sVEGFR1 posttherapy . In conclusion , tumor perfusion changes after antiangiogenic therapy may distinguish responders vs. nonresponders early in the course of this expensive and potentially toxic form of therapy , and these results may provide new insight into the selection of glioblastoma patients most likely to benefit from anti-VEGF treatments BACKGROUND Survival outcomes for patients with glioblastoma remain poor , particularly for patients with unmethylated O(6)-methylguanine-DNA methyltransferase ( MGMT ) gene promoter . This phase II , r and omized , open-label , multicenter trial investigated the efficacy and safety of 2 dose regimens of the selective integrin inhibitor cilengitide combined with st and ard chemoradiotherapy in patients with newly diagnosed glioblastoma and an unmethylated MGMT promoter . METHODS Overall , 265 patients were r and omized ( 1:1:1 ) to st and ard cilengitide ( 2000 mg 2 × /wk ; n = 88 ) , intensive cilengitide ( 2000 mg 5 × /wk during wk 1 - 6 , thereafter 2 × /wk ; n = 88 ) , or a control arm ( chemoradiotherapy alone ; n = 89 ) . Cilengitide was administered intravenously in combination with daily temozolomide ( TMZ ) and concomitant radiotherapy ( RT ; wk 1 - 6 ) , followed by TMZ maintenance therapy ( TMZ/RT→TMZ ) . The primary endpoint was overall survival ; secondary endpoints included progression-free survival , pharmacokinetics , and safety and tolerability . RESULTS Median overall survival was 16.3 months in the st and ard cilengitide arm ( hazard ratio [ HR ] , 0.686 ; 95 % CI : 0.484 , 0.972 ; P = .032 ) and 14.5 months in the intensive cilengitide arm ( HR , 0.858 ; 95 % CI : 0.612 , 1.204 ; P = .3771 ) versus 13.4 months in the control arm . Median progression-free survival assessed per independent review committee was 5.6 months ( HR , 0.822 ; 95 % CI : 0.595 , 1.134 ) and 5.9 months ( HR , 0.794 ; 95 % CI : 0.575 , 1.096 ) in the st and ard and intensive cilengitide arms , respectively , versus 4.1 months in the control arm . Cilengitide was well tolerated . CONCLUSIONS St and ard and intensive cilengitide dose regimens were well tolerated in combination with TMZ/RT→TMZ . Inconsistent overall survival and progression-free survival outcomes and a limited sample size did not allow firm conclusions regarding clinical efficacy in this exploratory phase II study PURPOSE This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma ( WHO grade 4 ) . PATIENTS AND METHODS Patients were r and omly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d ( 1,125-mg loading dose , day 1 ) or lomustine ( 100 to 130 mg/m(2 ) , day 1 ) . Assuming a 45 % improvement in progression-free survival ( PFS ) , 397 patients were required to provide 80 % power to achieve statistical significance at a one-sided level of .025 . RESULTS Enrollment was terminated at 266 patients ( enzastaurin , n = 174 ; lomustine , n = 92 ) after a planned interim analysis for futility . Patient characteristics were balanced between arms . Median PFS ( 1.5 v 1.6 months ; hazard ratio [ HR ] = 1.28 ; 95 % CI , 0.97 to 1.70 ) , overall survival ( 6.6 v 7.1 months ; HR = 1.20 ; 95 % CI , 0.88 to 1.65 ) , and 6-month PFS rate ( P = .13 ) did not differ significantly between enzastaurin and lomustine , respectively . Stable disease occurred in 38.5 % and 35.9 % of patients and objective response occurred in 2.9 % and 4.3 % of patients , respectively . Time to deterioration of physical and functional well-being and symptoms did not differ between arms ( HR = 1.12 ; P = .54 ) . Four patients discontinued enzastaurin because of drug-related serious adverse events ( AEs ) . Eleven patients treated with enzastaurin died on study ( four because of AEs ; one was drug-related ) . All four deaths that occurred in patients receiving lomustine were disease-related . Grade 3 to 4 hematologic toxicities were significantly higher with lomustine ( 46 events ) than with enzastaurin ( one event ; P < or = .001 ) . CONCLUSION Enzastaurin was well tolerated and had a better hematologic toxicity profile but did not have superior efficacy compared with lomustine in patients with recurrent glioblastoma PURPOSE To evaluate single-agent activity of bevacizumab in patients with recurrent glioblastoma . PATIENTS AND METHODS Patients with recurrent glioblastoma were treated with bevacizumab 10 mg/kg every 2 weeks . After tumor progression , patients were immediately treated with bevacizumab in combination with irinotecan 340 mg/m(2 ) or 125 mg/m(2 ) every 2 weeks , depending on use of enzyme-inducing antiepileptic drugs . Complete patient evaluations were repeated every 4 weeks . RESULTS Forty-eight heavily pretreated patients were accrued to this study . Thromboembolic events ( 12.5 % ) , hypertension ( 12.5 % ) , hypophosphatemia ( 6 % ) , and thrombocytopenia ( 6 % ) were the most common drug-associated adverse events . Six patients ( 12.5 % ) were removed from study for drug-associated toxicity ( five thromboembolic events , one bowel perforation ) . Thirty-four patients ( 71 % ) and 17 patients ( 35 % ) achieved radiographic response based on Levin and Macdonald criteria , respectively . Median progression-free survival ( PFS ) was 16 weeks ( 95 % CI , 12 to 26 weeks ) . The 6-month PFS was 29 % ( 95 % CI , 18 % to 48 % ) . The 6-month overall survival was 57 % ( 95 % CI , 44 % to 75 % ) . Median overall survival was 31 weeks ( 95 % CI , 21 to 54 weeks ) . Early magnetic resonance imaging response ( first 96 hours and 4 weeks ) was predictive of long-term PFS , with the Levin criteria being more predictive than Macdonald criteria . Of 19 patients treated with bevacizumab plus irinotecan at progression , there were no objective radiographic responses . Eighteen patients ( 95 % ) experienced disease progression by the second cycle , and the median PFS was 30 days . CONCLUSION We conclude that single-agent bevacizumab has significant biologic and antiglioma activity in patients with recurrent glioblastoma BACKGROUND Concurrent treatment with temozolomide and radiotherapy followed by maintenance temozolomide is the st and ard of care for patients with newly diagnosed glioblastoma . Bevacizumab , a humanized monoclonal antibody against vascular endothelial growth factor A , is currently approved for recurrent glioblastoma . Whether the addition of bevacizumab would improve survival among patients with newly diagnosed glioblastoma is not known . METHODS In this r and omized , double-blind , placebo-controlled trial , we treated adults who had central ly confirmed glioblastoma with radiotherapy ( 60 Gy ) and daily temozolomide . Treatment with bevacizumab or placebo began during week 4 of radiotherapy and was continued for up to 12 cycles of maintenance chemotherapy . At disease progression , the assigned treatment was revealed , and bevacizumab therapy could be initiated or continued . The trial was design ed to detect a 25 % reduction in the risk of death and a 30 % reduction in the risk of progression or death , the two co primary end points , with the addition of bevacizumab . RESULTS A total of 978 patients were registered , and 637 underwent r and omization . There was no significant difference in the duration of overall survival between the bevacizumab group and the placebo group ( median , 15.7 and 16.1 months , respectively ; hazard ratio for death in the bevacizumab group , 1.13 ) . Progression-free survival was longer in the bevacizumab group ( 10.7 months vs. 7.3 months ; hazard ratio for progression or death , 0.79 ) . There were modest increases in rates of hypertension , thromboembolic events , intestinal perforation , and neutropenia in the bevacizumab group . Over time , an increased symptom burden , a worse quality of life , and a decline in neurocognitive function were more frequent in the bevacizumab group . CONCLUSIONS First-line use of bevacizumab did not improve overall survival in patients with newly diagnosed glioblastoma . Progression-free survival was prolonged but did not reach the prespecified improvement target . ( Funded by the National Cancer Institute ; Clinical Trials.gov number , NCT00884741 . ) PURPOSE The prognosis for patients with recurrent glioblastoma multiforme is poor , with a median survival of 3 to 6 months . We performed a phase II trial of bevacizumab , a monoclonal antibody to vascular endothelial growth factor , in combination with irinotecan . PATIENTS AND METHODS This phase II trial included two cohorts of patients . The initial cohort , comprising 23 patients , received bevacizumab at 10 mg/kg plus irinotecan every 2 weeks . The dose of irinotecan was based on the patient 's anticonvulsant : Patients taking enzyme-inducing antiepileptic drugs ( EIAEDs ) received 340 mg/m2 , and patients not taking EIAEDs received 125 mg/m2 . After this regimen was deemed safe and effective , the irinotecan schedule was changed to an accepted brain tumor regimen of four doses in 6 weeks , in anticipation of a phase III r and omized trial of irinotecan versus irinotecan and bevacizumab . The second cohort , comprising 12 patients , received bevacizumab 15 mg/kg every 21 days and irinotecan on days 1 , 8 , 22 , and 29 . Each cycle was 6 weeks long and concluded with patient evaluations , including magnetic resonance imaging . RESULTS The 6-month progression-free survival among all 35 patients was 46 % ( 95 % CI , 32 % to 66 % ) . The 6-month overall survival was 77 % ( 95 % CI , 64 % to 92 % ) . Twenty of the 35 patients ( 57 % ; 95 % CI , 39 % to 74 % ) had at least a partial response . One patient developed a CNS hemorrhage , which occurred in his 10th cycle . Four patients developed thromboembolic complications ( deep venous thrombosis and /or pulmonary emboli ) . CONCLUSION Bevacizumab and irinotecan is an effective treatment for recurrent glioblastoma multiforme and has moderate toxicity Purpose : V and etanib , a tyrosine kinase inhibitor of KDR ( VEGFR2 ) , EGFR , and RET , may enhance sensitivity to chemotherapy and radiation . We conducted a r and omized , noncomparative , phase II study of radiation ( RT ) and temozolomide with or without v and etanib in patients with newly diagnosed glioblastoma ( GBM ) . Experimental Design : We planned to r and omize a total of 114 newly diagnosed GBM patients in a ratio of 2:1 to st and ard RT and temozolomide with ( 76 patients ) or without ( 38 patients ) v and etanib 100 mg daily . Patients with age ≥ 18 years , Karnofsky performance status ( KPS ) ≥ 60 , and not on enzyme-inducing antiepileptics were eligible . Primary endpoint was median overall survival ( OS ) from the date of r and omization . Secondary endpoints included median progression-free survival ( PFS ) , 12-month PFS , and safety . Correlative studies included pharmacokinetics as well as tissue and serum biomarker analysis . Results : The study was terminated early for futility based on the results of an interim analysis . We enrolled 106 patients ( 36 in the RT/temozolomide arm and 70 in the v and etanib/RT/temozolomide arm ) . Median OS was 15.9 months [ 95 % confidence interval ( CI ) , 11.0–22.5 months ] in the RT/temozolomide arm and 16.6 months ( 95 % CI , 14.9–20.1 months ) in the v and etanib/RT/temozolomide ( log-rank P = 0.75 ) . Conclusions : The addition of v and etanib at a dose of 100 mg daily to st and ard chemoradiation in patients with newly diagnosed GBM or gliosarcoma was associated with potential pharmacodynamic biomarker changes and was reasonably well tolerated . However , the regimen did not significantly prolong OS compared with the parallel control arm , leading to early termination of the study . Clin Cancer Res ; 21(16 ) ; 3610–8 . © 2015 AACR PURPOSE The combination of a vascular endothelial growth factor ( VEGF ) -neutralizing antibody , bevacizumab , and irinotecan is associated with high radiographic response rates and improved survival outcomes in patients with recurrent malignant gliomas . The aim of these retrospective studies was to evaluate tumor vascularity and expression of components of the VEGF pathway and hypoxic responses as predictive markers for radiographic response and survival benefit from the bevacizumab and irinotecan therapy . PATIENTS AND METHODS In a phase II trial , 60 patients with recurrent malignant astrocytomas were treated with bevacizumab and irinotecan . Tumor specimens collected at the time of diagnosis were available for further pathologic studies in 45 patients ( 75 % ) . VEGF , VEGF receptor-2 , CD31 , hypoxia-inducible carbonic anhydrase 9 ( CA9 ) , and hypoxia-inducible factor-2alpha were semiquantitatively assessed by immunohistochemistry . Radiographic response and survival outcomes were correlated with these angiogenic and hypoxic markers . RESULTS Of 45 patients , 27 patients had glioblastoma multiforme , and 18 patients had anaplastic astrocytoma . Twenty-six patients ( 58 % ) had at least partial radiographic response . High VEGF expression was associated with increased likelihood of radiographic response ( P = .024 ) but not survival benefit . Survival analysis revealed that high CA9 expression was associated with poor survival outcome ( P = .016 ) . CONCLUSION In this patient cohort , tumor expression levels of VEGF , the molecular target of bevacizumab , were associated with radiographic response , and the upstream promoter of angiogenesis , hypoxia , determined survival outcome , as measured from treatment initiation . Validation in a larger clinical trial is warranted PURPOSE We evaluated the efficacy of bevacizumab , alone and in combination with irinotecan , in patients with recurrent glioblastoma in a phase II , multicenter , open-label , noncomparative trial . PATIENTS AND METHODS One hundred sixty-seven patients were r and omly assigned to receive bevacizumab 10 mg/kg alone or in combination with irinotecan 340 mg/m(2 ) or 125 mg/m(2 ) ( with or without concomitant enzyme-inducing antiepileptic drugs , respectively ) once every 2 weeks . Primary end points were 6-month progression-free survival and objective response rate , as determined by independent radiology review . Secondary end points included safety and overall survival . RESULTS In the bevacizumab-alone and the bevacizumab-plus-irinotecan groups , estimated 6-month progression-free survival rates were 42.6 % and 50.3 % , respectively ; objective response rates were 28.2 % and 37.8 % , respectively ; and median overall survival times were 9.2 months and 8.7 months , respectively . There was a trend for patients who were taking corticosteroids at baseline to take stable or decreasing doses over time . Of the patients treated with bevacizumab alone or bevacizumab plus irinotecan , 46.4 % and 65.8 % , respectively , experienced grade > or = 3 adverse events , the most common of which were hypertension ( 8.3 % ) and convulsion ( 6.0 % ) in the bevacizumab-alone group and convulsion ( 13.9 % ) , neutropenia ( 8.9 % ) , and fatigue ( 8.9 % ) in the bevacizumab-plus-irinotecan group . Intracranial hemorrhage was noted in two patients ( 2.4 % ) in the bevacizumab-alone group ( grade 1 ) and in three patients ( 3.8 % ) patients in the bevacizumab-plus-irinotecan group ( grade s 1 , 2 , and 4 , respectively ) . CONCLUSION Bevacizumab , alone or in combination with irinotecan , was well tolerated and active in recurrent glioblastoma BACKGROUND Prognosis of unresectable glioblastoma ( GB ) remains poor , despite temozolomide (TMZ)-based chemoradiation . Activity of bevacizumab ( BEV ) and irinotecan ( IRI ) has been reported in recurrent disease . We evaluated BEV and IRI as neo-adjuvant and adjuvant treatment combined with TMZ-based chemoradiation for unresectable GB . PATIENTS AND METHODS Patients with unresectable GB , age 18 - 70 , IK ≥50 were eligible . The experimental arm ( BEV/IRI ) consisted of neo-adjuvant intravenous BEV , 10 mg/kg , and IRI , 125 mg/m(2 ) , every 2 weeks for four cycles before radiotherapy ( RT ) ( 60 Gy ) , concomitant oral TMZ , 75 mg/m(2)/day , and BEV , 10 mg/kg every 2 weeks . Adjuvant BEV and IRI were given every 2 weeks for 6 months . The control arm consisted of concomitant oral TMZ , 75 mg/m(2)/day during RT , and 150 - 200 mg/m(2 ) for 5 days every 28 days for 6 months . The use of BEV was allowed at progression in the control arm . RESULTS Patients ( 120 ) were included from April 2009 to January 2011 . The working hypothesis was that treatment would increase the progression-free survival at 6 month ( PFS-6 ) from 50 % to 66 % . The primary objective was not achieved , and only 30 out of 60 patients were alive without progression at 6 months ( 50.0 % [ IC95 % ( 36.8 ; 63.1 ) ] in the BEV/IRI arm when 37 out of 60 patients were required according to the Fleming decision rules . PFS-6 was 7.1 months in BEV/IRI versus 5.2 months in the control arm . The median overall survival was not different between the two arms ( 11.1 months ) . Main toxicities were three fatal intracranial bleedings , three bile duct or digestive perforations/infections ( 1 fatal ) , and six thrombotic episodes in the BEV/IRI arm , whereas there was one intracranial bleeding , two bile duct or digestive perforations/infections ( 1 fatal ) , and one thrombotic episode in the control arm . CONCLUSIONS Neo-adjuvant and adjuvant BEV/IRI , combined with TMZ-radiation , is not recommended for further evaluation in the first-line treatment of unresectable GB . CLINICAL TRIAL REGISTRATION Clinical trial registered under EUDRACT number 2008 - 002775 - 28 ( NCT01022918 ) PURPOSE Maintenance therapy is associated with improved survival in patients with non-small-cell lung cancer ( NSCLC ) , but few studies have compared active agents in this setting . AVAPERL evaluated the safety and efficacy of bevacizumab with or without pemetrexed as continuation maintenance treatment . PATIENTS AND METHODS Patients with advanced nonsquamous NSCLC received first-line bevacizumab 7.5 mg/kg , cisplatin 75 mg/m(2 ) , and pemetrexed 500 mg/m(2 ) once every 3 weeks for four cycles . Those achieving response or stable disease were r and omly assigned at a ratio of 1:1 to maintenance bevacizumab 7.5 mg/kg or bevacizumab 7.5 mg/kg plus pemetrexed 500 mg/m(2 ) once every 3 weeks until disease progression or unacceptable toxicity . The primary end point was progression-free survival ( PFS ) after r and om assignment . RESULTS In total , 376 patients received induction treatment , 71.9 % achieved disease control , and 67.3 % were r and omly assigned to maintenance therapy , with 125 and 128 receiving single-agent bevacizumab and bevacizumab plus pemetrexed treatment , respectively . At a median follow-up of 8.1 months , PFS from r and om assignment was significantly improved in the bevacizumab plus pemetrexed arm ( median , 3.7 v 7.4 months ; hazard ratio , 0.48 ; 95 % CI , 0.35 to 0.66 ; P < .001 ) per a stratified model . The PFS benefit extended across age , performance status , smoking history , and induction response ( stable disease v partial response ) subgroups . Any grade , grade ≥ 3 , and serious adverse events occurred more often with bevacizumab plus pemetrexed maintenance . No new safety signals were observed . CONCLUSION In an unselected population of patients with nonsquamous NSCLC who had achieved disease control with platinum-based chemotherapy plus bevacizumab , bevacizumab plus pemetrexed maintenance was associated with a significant PFS benefit compared with bevacizumab alone . The combination was well tolerated BACKGROUND In 2004 , a r and omised phase III trial by the European Organisation for Research and Treatment of Cancer ( EORTC ) and National Cancer Institute of Canada Clinical Trials Group ( NCIC ) reported improved median and 2-year survival for patients with glioblastoma treated with concomitant and adjuvant temozolomide and radiotherapy . We report the final results with a median follow-up of more than 5 years . METHODS Adult patients with newly diagnosed glioblastoma were r and omly assigned to receive either st and ard radiotherapy or identical radiotherapy with concomitant temozolomide followed by up to six cycles of adjuvant temozolomide . The methylation status of the methyl-guanine methyl transferase gene , MGMT , was determined retrospectively from the tumour tissue of 206 patients . The primary endpoint was overall survival . Analyses were by intention to treat . This trial is registered with Clinical trials.gov , number NCT00006353 . FINDINGS Between Aug 17 , 2000 , and March 22 , 2002 , 573 patients were assigned to treatment . 278 ( 97 % ) of 286 patients in the radiotherapy alone group and 254 ( 89 % ) of 287 in the combined-treatment group died during 5 years of follow-up . Overall survival was 27.2 % ( 95 % CI 22.2 - 32.5 ) at 2 years , 16.0 % ( 12.0 - 20.6 ) at 3 years , 12.1 % ( 8.5 - 16.4 ) at 4 years , and 9.8 % ( 6.4 - 14.0 ) at 5 years with temozolomide , versus 10.9 % ( 7.6 - 14.8 ) , 4.4 % ( 2.4 - 7.2 ) , 3.0 % ( 1.4 - 5.7 ) , and 1.9 % ( 0.6 - 4.4 ) with radiotherapy alone ( hazard ratio 0.6 , 95 % CI 0.5 - 0.7 ; p<0.0001 ) . A benefit of combined therapy was recorded in all clinical prognostic subgroups , including patients aged 60 - 70 years . Methylation of the MGMT promoter was the strongest predictor for outcome and benefit from temozolomide chemotherapy . INTERPRETATION Benefits of adjuvant temozolomide with radiotherapy lasted throughout 5 years of follow-up . A few patients in favourable prognostic categories survive longer than 5 years . MGMT methylation status identifies patients most likely to benefit from the addition of temozolomide . FUNDING EORTC , NCIC , Nélia and Amadeo Barletta Foundation , Schering-Plough BACKGROUND Cilengitide is a selective αvβ3 and αvβ5 integrin inhibitor . Data from phase 2 trials suggest that it has antitumour activity as a single agent in recurrent glioblastoma and in combination with st and ard temozolomide chemoradiotherapy in newly diagnosed glioblastoma ( particularly in tumours with methylated MGMT promoter ) . We aim ed to assess cilengitide combined with temozolomide chemoradiotherapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter . METHODS In this multicentre , open-label , phase 3 study , we investigated the efficacy of cilengitide in patients from 146 study sites in 25 countries . Eligible patients ( newly diagnosed , histologically proven supratentorial glioblastoma , methylated MGMT promoter , and age ≥18 years ) were stratified for prognostic Radiation Therapy Oncology Group recursive partitioning analysis class and geographic region and central ly r and omised in a 1:1 ratio with interactive voice response system to receive temozolomide chemoradiotherapy with cilengitide 2000 mg intravenously twice weekly ( cilengitide group ) or temozolomide chemoradiotherapy alone ( control group ) . Patients and investigators were unmasked to treatment allocation . Maintenance temozolomide was given for up to six cycles , and cilengitide was given for up to 18 months or until disease progression or unacceptable toxic effects . The primary endpoint was overall survival . We analysed survival outcomes by intention to treat . This study is registered with Clinical Trials.gov , number NCT00689221 . FINDINGS Overall , 3471 patients were screened . Of these patients , 3060 had tumour MGMT status tested ; 926 patients had a methylated MGMT promoter , and 545 were r and omly assigned to the cilengitide ( n=272 ) or control groups ( n=273 ) between Oct 31 , 2008 , and May 12 , 2011 . Median overall survival was 26·3 months ( 95 % CI 23·8 - 28·8 ) in the cilengitide group and 26·3 months ( 23·9 - 34·7 ) in the control group ( hazard ratio 1·02 , 95 % CI 0·81 - 1·29 , p=0·86 ) . None of the predefined clinical subgroups showed a benefit from cilengitide . We noted no overall additional toxic effects with cilengitide treatment . The most commonly reported adverse events of grade 3 or worse in the safety population were lymphopenia ( 31 [ 12 % ] in the cilengitide group vs 26 [ 10 % ] in the control group ) , thrombocytopenia ( 28 [ 11 % ] vs 46 [ 18 % ] ) , neutropenia ( 19 [ 7 % ] vs 24 [ 9 % ] ) , leucopenia ( 18 [ 7 % ] vs 20 [ 8 % ] ) , and convulsion ( 14 [ 5 % ] vs 15 [ 6 % ] ) . INTERPRETATION The addition of cilengitide to temozolomide chemoradiotherapy did not improve outcomes ; cilengitide will not be further developed as an anticancer drug . Nevertheless , integrins remain a potential treatment target for glioblastoma . FUNDING Merck KGaA , Darmstadt , Germany BACKGROUND In this post-hoc , exploratory analysis , we examined outcomes for patients enrolled in the AVAglio trial of front-line bevacizumab or placebo plus radiotherapy/temozolomide who received only a single line of therapy . METHODS Patients with newly diagnosed glioblastoma received protocol -defined treatment until progressive disease ( PD ) . Co- primary endpoints were investigator-assessed progression-free survival ( PFS ) and overall survival ( OS ) . After confirmed PD , patients were treated at the investigators ' discretion . PFS/OS were assessed in patients with a PFS event who did not receive post-PD therapy ( Group 1 ) and patients with a PFS event who received post-PD therapy plus patients who did not have a PFS event at the final data cutoff ( Group 2 ) . Kaplan-Meier methodology was used . A multivariate Cox proportional hazards model for known prognostic variables was generated . RESULTS Baseline characteristics were balanced . In patients with a PFS event who did not receive post-PD therapy ( Group 1 ; n = 225 [ 24.4 % of the intent-to-treat population ] ) , the addition of bevacizumab to radiotherapy/temozolomide result ed in a 3.6-month extension in both median PFS ( hazard ratio [ HR ] : 0.62 , P = .0016 ) and median OS ( HR : 0.67 , P = .0102 ) . Multivariate analyses supported this OS benefit ( HR : 0.66 ) . In the remaining patients ( Group 2 ; n = 696 ) , a 5.2-month PFS extension was observed in bevacizumab-treated patients ( HR : 0.61 , P < .0001 ) ; OS was comparable between the treatment arms ( HR : 0.88 , P = .1502 ) . No significant differences in safety were observed between the 2 groups . CONCLUSION This exploratory analysis suggests that the addition of bevacizumab to st and ard glioblastoma treatment prolongs PFS and OS for patients with PD who receive only one line of therapy PURPOSE A r and omized , phase III , placebo-controlled , partially blinded clinical trial ( REGAL [ Recent in in Glioblastoma Alone and With Lomustine ] ) was conducted to determine the efficacy of cediranib , an oral pan-vascular endothelial growth factor ( VEGF ) receptor tyrosine kinase inhibitor , either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma . PATIENTS AND METHODS Patients ( N = 325 ) with recurrent glioblastoma who previously received radiation and temozolomide were r and omly assigned 2:2:1 to receive ( 1 ) cediranib ( 30 mg ) monotherapy ; ( 2 ) cediranib ( 20 mg ) plus lomustine ( 110 mg/m(2 ) ) ; ( 3 ) lomustine ( 110 mg/m(2 ) ) plus a placebo . The primary end point was progression-free survival based on blinded , independent radiographic assessment of postcontrast T1-weighted and noncontrast T2-weighted magnetic resonance imaging ( MRI ) brain scans . RESULTS The primary end point of progression-free survival ( PFS ) was not significantly different for either cediranib alone ( hazard ratio [ HR ] = 1.05 ; 95 % CI , 0.74 to 1.50 ; two-sided P = .90 ) or cediranib in combination with lomustine ( HR = 0.76 ; 95 % CI , 0.53 to 1.08 ; two-sided P = .16 ) versus lomustine based on independent or local review of postcontrast T1-weighted MRI . CONCLUSION This study did not meet its primary end point of PFS prolongation with cediranib either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma , although cediranib showed evidence of clinical activity on some secondary end points including time to deterioration in neurologic status and corticosteroid-sparing effects BACKGROUND St and ard therapy for newly diagnosed glioblastoma is radiotherapy plus temozolomide . In this phase 3 study , we evaluated the effect of the addition of bevacizumab to radiotherapy-temozolomide for the treatment of newly diagnosed glioblastoma . METHODS We r and omly assigned patients with supratentorial glioblastoma to receive intravenous bevacizumab ( 10 mg per kilogram of body weight every 2 weeks ) or placebo , plus radiotherapy ( 2 Gy 5 days a week ; maximum , 60 Gy ) and oral temozolomide ( 75 mg per square meter of body-surface area per day ) for 6 weeks . After a 28-day treatment break , maintenance bevacizumab ( 10 mg per kilogram intravenously every 2 weeks ) or placebo , plus temozolomide ( 150 to 200 mg per square meter per day for 5 days ) , was continued for six 4-week cycles , followed by bevacizumab monotherapy ( 15 mg per kilogram intravenously every 3 weeks ) or placebo until the disease progressed or unacceptable toxic effects developed . The co primary end points were investigator-assessed progression-free survival and overall survival . RESULTS A total of 458 patients were assigned to the bevacizumab group , and 463 patients to the placebo group . The median progression-free survival was longer in the bevacizumab group than in the placebo group ( 10.6 months vs. 6.2 months ; stratified hazard ratio for progression or death , 0.64 ; 95 % confidence interval [ CI ] , 0.55 to 0.74 ; P<0.001 ) . The benefit with respect to progression-free survival was observed across subgroups . Overall survival did not differ significantly between groups ( stratified hazard ratio for death , 0.88 ; 95 % CI , 0.76 to 1.02 ; P=0.10 ) . The respective overall survival rates with bevacizumab and placebo were 72.4 % and 66.3 % at 1 year ( P=0.049 ) and 33.9 % and 30.1 % at 2 years ( P=0.24 ) . Baseline health-related quality of life and performance status were maintained longer in the bevacizumab group , and the glucocorticoid requirement was lower . More patients in the bevacizumab group than in the placebo group had grade 3 or higher adverse events ( 66.8 % vs. 51.3 % ) and grade 3 or higher adverse events often associated with bevacizumab ( 32.5 % vs. 15.8 % ) . CONCLUSIONS The addition of bevacizumab to radiotherapy-temozolomide did not improve survival in patients with glioblastoma . Improved progression-free survival and maintenance of baseline quality of life and performance status were observed with bevacizumab ; however , the rate of adverse events was higher with bevacizumab than with placebo . ( Funded by F. Hoffmann-La Roche ; Clinical Trials.gov number , NCT00943826 . ) PURPOSE The AVAglio ( Avastin in Glioblastoma ) and RTOG-0825 r and omized , placebo-controlled phase III trials in newly diagnosed glioblastoma reported prolonged progression-free survival ( PFS ) , but not overall survival ( OS ) , with the addition of bevacizumab to radiotherapy plus temozolomide . To establish whether certain patient subgroups derived an OS benefit from the addition of bevacizumab to first-line st and ard-of-care therapy , AVAglio patients were retrospectively evaluated for molecular subtype , and bevacizumab efficacy was assessed for each patient subgroup . PATIENTS AND METHODS A total of 349 pretreatment specimens ( bevacizumab arm , n = 171 ; placebo arm , n = 178 ) from AVAglio patients ( total , N = 921 ) were available for biomarker analysis . Sample s were profiled for gene expression and isocitrate dehydrogenase 1 ( IDH1 ) mutation status and classified into previously identified molecular subtypes . PFS and OS were assessed within each subtype . RESULTS A multivariable analysis accounting for prognostic covariates revealed that bevacizumab conferred a significant OS advantage versus placebo for patients with proneural IDH1 wild-type tumors ( 17.1 v 12.8 months , respectively ; hazard ratio , 0.43 ; 95 % CI , 0.26 to 0.73 ; P = .002 ) . This analysis also revealed an interaction between the proneural subtype biomarker and treatment arm ( P = .023 ) . The group of patients with mesenchymal and proneural tumors derived a PFS benefit from bevacizumab compared with placebo ; however , this translated to an OS benefit in the proneural subset only . CONCLUSION Retrospective analysis of AVAglio data suggests that patients with IDH1 wild-type proneural glioblastoma may derive an OS benefit from first-line bevacizumab treatment . The predictive value of the proneural subtype observed in AVAglio should be vali date d in an independent data set |
1,348 | 27,011,260 | Similar findings were observed in estimates applying to general CHD .
No significant improvement in model fit was found after adjusting for study -level covariates .
Large between- study heterogeneity was observed in all the models investigated .
The main finding of our study is the presence of large heterogeneity both within and between instrument-specific HRQoL values . | BACKGROUND There are numerous health-related quality of life ( HRQol ) measurements used in coronary heart disease ( CHD ) in the literature .
However , only values assessed with preference-based instruments can be directly applied in a cost-utility analysis ( CUA ) .
OBJECTIVE To summarize and synthesize instrument-specific preference-based values in CHD and the underlying disease-subgroups , stable angina and post-acute coronary syndrome ( post-ACS ) , for developed countries , while accounting for study -level characteristics , and within- and between- study correlation . | BACKGROUND The recent recognition that coronary-artery stenting has improved the short- and long-term outcomes of patients treated with angioplasty has made it necessary to reevaluate the relative benefits of bypass surgery and percutaneous interventions in patients with multivessel disease . METHODS A total of 1205 patients were r and omly assigned to undergo stent implantation or bypass surgery when a cardiac surgeon and an interventional cardiologist agreed that the same extent of revascularization could be achieved by either technique . The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events at one year . The costs of hospital re sources used were also determined . RESULTS At one year , there was no significant difference between the two groups in terms of the rates of death , stroke , or myocardial infa rct ion . Among patients who survived without a stroke or a myocardial infa rct ion , 16.8 percent of those in the stenting group underwent a second revascularization , as compared with 3.5 percent of those in the surgery group . The rate of event-free survival at one year was 73.8 percent among the patients who received stents and 87.8 percent among those who underwent bypass surgery ( P<0.001 by the log-rank test ) . The costs for the initial procedure were $ 4,212 less for patients assigned to stenting than for those assigned to bypass surgery , but this difference was reduced during follow-up because of the increased need for repeated revascularization ; after one year , the net difference in favor of stenting was estimated to be $ 2,973 per patient . CONCLUSION As measured one year after the procedure , coronary stenting for multivessel disease is less expensive than bypass surgery and offers the same degree of protection against death , stroke , and myocardial infa rct ion . However , stenting is associated with a greater need for repeated revascularization Purpose : We sought to compare directly elicited valuations for EQ-5D health states between the US and UK general adult population s. Methods : We analyzed data from 2 EQ-5D valuation studies where , using similar time trade-off protocol s , values for 42 common health states were elicited from representative sample s of the US and UK general adult population s. First , US and UK population mean valuations were estimated and compared for each health state . Second , r and om-effect models were used to compare the US and UK valuations while adjusting for known predictors of EQ-5D valuations ( ie , age , sex , health state descriptors ) and to investigate whether and how the valuations differ . Results : Population mean valuations of the 42 health states ranged from −0.38 to 0.88 for the United States and from −0.54 to 0.88 for the United Kingdom , with the US mean scores being numerically higher than the UK for 39 health states ( mean difference : 0.11 ; range : −0.01 to 0.25 ) . After adjusting for the main effects of known predictors , the average difference in valuations was 0.10 ( P < 0.001 ) . The magnitude of the difference in the US and UK valuations was not constant across EQ-5D health states ; greater differences in valuations were present in health states characterized by extreme problems . Conclusions : Meaningful differences exist in directly elicited TTO valuations of EQ-5D health states between the US and UK general population s. Therefore , EQ-5D index scores generated using valuations from the US general population should be used for studies aim ing to reflect health state preferences of the US general public BACKGROUND The SF-6D is a new health state classification and utility scoring system based on 6 dimensions ( ' 6D ' ) of the Short Form 36 , and permits a " bridging " transformation between SF-36 responses and utilities . The Health Utilities Index , mark 3 ( HUI3 ) is a valid and reliable multi-attribute health utility scale that is widely used . We assessed within-subject agreement between SF-6D utilities and those from HUI3 . METHODS Patients at increased risk of sudden cardiac death and participating in a r and omized trial of implantable defibrillator therapy completed both instruments at baseline . Score distributions were inspected by scatterplot and histogram and mean score differences compared by paired t-test . Pearson correlation was computed between instrument scores and also between dimension scores within instruments . Between-instrument agreement was by intra-class correlation coefficient ( ICC ) . RESULTS SF-6D and HUI3 forms were available from 246 patients . Mean scores for HUI3 and SF-6D were 0.61 ( 95 % CI 0.60 - 0.63 ) and 0.58 ( 95 % CI 0.54 - 0.62 ) respectively ; a difference of 0.03 ( p<0.03 ) . Score intervals for HUI3 and SF-6D were ( -0.21 to 1.0 ) and ( 0.30 - 0.95 ) . Correlation between the instrument scores was 0.58 ( 95 % CI 0.48 - 0.68 ) and agreement by ICC was 0.42 ( 95 % CI 0.31 - 0.52 ) . Correlations between dimensions of SF-6D were higher than for HUI3 . CONCLUSIONS Our study casts doubt on the whether utilities and QALYs estimated via SF-6D are comparable with those from HUI3 . Utility differences may be due to differences in underlying concepts of health being measured , or different measurement approaches , or both . No gold st and ard exists for utility measurement and the SF-6D is a valuable addition that permits SF-36 data to be transformed into utilities to estimate QALYs . The challenge is developing a better underst and ing as to why these classification-based utility instruments differ so markedly in their distributions and point estimates of derived utilities The objective of this study is to evaluate the costs and health benefits of coronary artery bypass grafting ( CABG ) surgery with and without cardiopulmonary bypass ( CPB ) . R and omized controlled clinical trial is used as the design . The setting is in a single tertiary cardiothoracic center in Middlesex , UK . Participants were 168 patients ( 27 females ) requiring primary isolated CABG surgery . Patients were r and omized to have the procedure performed by a single surgeon either with CPB ( n = 84 ) or by an off-pump coronary artery bypass ( OPCAB ) surgery ( n = 84 ) . Health-related quality of life was assessed at baseline , 6 weeks , and 6 months using the World Health Organization Quality -of-Life ( WHOQOL-100 ) question naire . Mean total costs of patient management by either technique were calculated using different available key sources . A utility measure , derived from WHOQOL-100 , was used to calculate quality -adjusted life year ( QALY ) gained in each group , on basis of which a cost-effectiveness analysis was performed . The mean total costs of an OPCAB patient was 5859 pounds , whereas for a CPB patient it was 7431 pounds with a mean difference of 1572 pounds ( st and ard error [ SE ] 674 pounds ; P = 0.02 ) . Three patients died in the CPB group and two in the OPCAB group during the 6-month follow-up period . Mean QALYs over 6 months was 0.379 in the OPCAB group and 0.362 in the CPB group , but the difference was not significant ( mean difference 0.017 ; SE 0.016 ; P = 0.305 ) . OPCAB surgery offered patients in this r and omized trial similar health benefits to CPB over a 6-month period , but at a significantly less cost The Beaver Dam Health Outcomes Study ( BDHOS ) is an ongoing longitudinal cohort study of health status and health-related quality of life for a r and om sample of adults ( age range at interview was 45 to 89 years ; mean = 64.1 , SD = 10.8 ) in a community population . In a face-to-face interview lasting approximately an hour , each participant responds to several batteries of questions . Included are a history of chronic medical conditions , current medi cations , and past surgeries ; the SF-36 ( a general health-status question naire ) ; the Quality of Well-being index ; self-rated health status on a five-point scale from " excellent " to " poor " ; and evaluation of current health using the method of time tradeoffs . The authors present results from 1,356 interviews on these four principal measures , reporting mean scores by sex , by age , and for persons reporting being affected by various medical conditions . They believe data from the BDHOS will provide research ers and policy makers a reference col lection of vital statistics for health-related quality of life . Additionally , the data provide a way to compare results from studies that utilize different indices from among the four principal measures of the BDHOS . Key words : health status ; quality of life ( health-related ) ; population study ; cohort study . ( Med Decis Making 1993;13:89 - 102 OBJECTIVES To assess the acceptability and feasibility of functional tests as a gateway to angiography for management of coronary artery disease ( CAD ) , the ability of diagnostic strategies to identify patients who should undergo revascularisation , patient outcomes in each diagnostic strategy , and the most cost-effective diagnostic strategy for patients with suspected or known CAD . DESIGN A rapid systematic review of economic evaluations of alternative diagnostic strategies for CAD was carried out . A pragmatic and generalisable r and omised controlled trial was undertaken to assess the use of the functional cardiac tests : angiography ( controls ) ; single photon emission computed tomography ( SPECT ) ; magnetic resonance imaging ( MRI ) ; stress echocardiography . SETTING The setting was Papworth Hospital NHS Foundation Trust , a tertiary cardiothoracic referral centre . PARTICIPANTS Patients with suspected or known CAD and an exercise test result that required non-urgent angiography . INTERVENTIONS Patients were r and omised to one of the four initial diagnostic tests . MAIN OUTCOME MEASURES Eighteen months post-r and omisation : exercise time ( modified Bruce protocol ) ; cost-effectiveness compared with angiography ( diagnosis , treatment and follow-up costs ) . The aim was to demonstrate equivalence in exercise time between those r and omised to functional tests and those r and omised to angiography [ defined as the confidence interval ( CI ) for mean difference from angiography within 1 minute ] . RESULTS The 898 patients were r and omised to angiography ( n = 222 ) , SPECT ( n = 224 ) , MRI ( n = 226 ) or stress echo ( n = 226 ) . Initial diagnostic tests were completed successfully with unequivocal results for 98 % of angiography , 94 % of SPECT ( p = 0.05 ) , 78 % of MRI ( p < 0.001 ) and 90 % of stress echocardiography patients ( p < 0.001 ) . Some 22 % of SPECT patients , 20 % of MRI patients and 25 % of stress echo patients were not subsequently referred for an angiogram . Positive functional tests were confirmed by positive angiography in 83 % of SPECT patients , 89 % of MRI patients and 84 % of stress echo patients . Negative functional tests were followed by positive angiograms in 31 % of SPECT patients , 52 % of MRI patients and 48 % of stress echo patients tested . The proportions that had coronary artery bypass graft surgery were 10 % ( angiography ) , 11 % ( MRI ) and 13 % ( SPECT and stress echo ) and percutaneous coronary intervention 25 % ( angiography ) , 18 % ( SPECT ) and 23 % ( MRI and stress echo ) . At 18 months , comparing SPECT and stress echo with angiography , a clinical ly significant difference in total exercise time can be ruled out . The MRI group had significantly shorter mean total exercise time of 35 seconds and the upper limit of the CI was 1.14 minutes less than in the angiography group , so a difference of at least 1 minute can not be ruled out . At 6 months post-treatment , SPECT and angiography had equivalent mean exercise time . Compared with angiography , the MRI and stress echo groups had significantly shorter mean total exercise time of 37 and 38 seconds , respectively , and the upper limit of both CIs was 1.16 minutes , so a difference of at least 1 minute can not be ruled out . The differences were mainly attributable to revascularised patients . There were significantly more non-fatal adverse events in the stress echo group , mostly admissions for chest pain , but no significant difference in the number of patients reporting events . Mean ( 95 % CI ) total additional costs over 18 months , compared with angiography , were 415 pounds ( -310 pounds to 1084 pounds ) for SPECT , 426 pounds ( -247 pounds to 1088 pounds ) for MRI and 821 pounds ( 10 pounds to 1715 pounds ) for stress echocardiography , with very little difference in quality -adjusted life-years ( QALYs ) amongst the groups ( less than 0.04 QALYs over 18 months ) . Cost-effectiveness was mainly influenced by test costs , clinicians ' willingness to trust negative functional tests and by a small number of patients who had a particularly difficult clinical course . CONCLUSIONS Between 20 and 25 % of patients can avoid invasive testing using functional testing as a gateway to angiography , without substantial effects on outcomes . The SPECT strategy was as useful as angiography in identifying patients who should undergo revascularisation and the additional cost was not significant , in fact it would be reduced further by restricting the rest test to patients who have a positive stress test . MRI had the largest number of test failures and , in this study , had the least practical use in screening patients with suspected CAD , although it had similar outcomes to stress echo and is still an evolving technology . Stress echo patients had a 10 % test failure rate , significantly shorter total exercise time and time to angina at 6 months post-treatment , and a greater number of adverse events , leading to significantly higher costs . Given the level of skill required for stress echo , it may be best to reserve this test for those who have a contraindication to SPECT and are unable or unwilling to have MRI . Further research , using blinded re assessment of functional test results and angiograms , is required to formally assess diagnostic accuracy . Longer-term cost-effectiveness analysis , and further studies of MRI and new generation computed tomography are also required OBJECTIVES This investigation was undertaken to study the costs of a Case Method Learning (CML)-supported lipid-lowering strategy in secondary prevention of coronary artery disease ( CAD ) in primary care . METHODS This prospect i ve r and omized controlled trial in primary care with an additional external specialist control group in Södertälje , Stockholm County , Sweden , included 255 consecutive patients with CAD . Guidelines were mailed to all general practitioners ( GPs ; n=54 ) and presented at a common lecture . GPs who were r and omized to the intervention group participated in recurrent CML dialogues at their primary health-care centers during a 2-year period . A locally well-known cardiologist served as a facilitator . Assessment of low-density lipoprotein ( LDL ) cholesterol was performed at baseline and after 2 years . Analysis according to intention-to-treat-intervention and control groups (n=88)--was based on group affiliation at baseline . The marginal cost of lipid lowering comprised increased cost of lipid-lowering drugs in the intervention group compared with the primary care control group , cost of attendance of the GP 's in the intervention group , and cost of time for preparation , travel , and seminars of the facilitator . Costs are as of 2002 with an exchange rate 1 U.S. dollar = 9.5 SEK ( Swedish Crowns ) . RESULTS Patients in the primary care intervention group had their LDL cholesterol reduced by 0.5 ( confidence interval [ CI ] , 0.1 - 0.9 ) mmol/L compared with the primary care control group ( p < .05 ) . No change occurred in controls . LDL cholesterol in the external specialist control group decreased by 0.6 ( CI , 0.4 - 0.8 ) mmol/L. The cost of the educational intervention represented only 2 percent of the drug cost . The cost of lipid lowering in the intervention group , including the cost of the educational intervention , was actually lower than that of patients treated at the specialist clinic--106 U.S. dollar per mmol decrease in LDL cholesterol in the intervention group and 153 U.S. dollar per mmol decrease in LDL cholesterol in the specialist group . EuroQol 5D Index , which gives an estimate of global health-related quality of life , was 0.80 ( CI , 0.75 - 0.85 ) in the present cohort . CONCLUSIONS The additional cost of CML was only 2 percent of the drug cost . Assuming the same gain in life expectancy per millimole decrease in LDL cholesterol as in the 4S- study gives a cost per gained quality -adjusted life year of U.S. dollar 24,000 . This finding indicates that the CML-supported lipid-lowering strategy is cost-effective . The low cost of CML in primary care should probably warrant its use in the improvement of the quality of care in other major chronic diseases Objectives . To assess the health related quality of life ( HRQoL ) and the change in the NYHA class after coronary artery bypass grafting ( CABG ) or percutaneous coronary intervention ( PCI ) in the management of stable coronary artery disease ( CAD ) . The study was non-r and omized . CABG group consisted of 240 patients and 229 patients were treated with PCI . HRQoL was measured prospect ively by the 15D instrument . Results . Three-year survival was 95.0 and 95.6 % ( NS ) . The HRQoL improved statistically in both groups until 6 months after treatment but deteriorated towards the end of the follow-up of 36 months . Clinical ly evident improvement of the HRQoL and decrease of the NYHA class took place more frequently among CABG patients . Conclusions . Despite initially more serious preoperative state and more dem and ing procedure CABG patients achieve equal level of HRQoL when compared with PCI patients . CABG patients may also obtain better relief from symptoms in mid-term follow-up . HRQoL can not be the only factor to determine outcome after invasive treatment of CAD but it has to be placed in the context of the overall situation Objective To assess whether revascularisation that is considered to be clinical ly appropriate is also cost effective . Design Prospect i ve observational study comparing cost effectiveness of coronary artery bypass grafting , percutaneous coronary intervention , or medical management within groups of patients rated as appropriate for revascularisation . Setting Three tertiary care centres in London . Participants Consecutive , unselected patients rated as clinical ly appropriate ( using a nine member Delphi panel ) to receive coronary artery bypass grafting only ( n=815 ) ; percutaneous coronary intervention only ( n=385 ) ; or both revascularisation procedures ( n=520 ) . Main outcome measure Cost per quality adjusted life year gained over six year follow-up , calculated with a National Health Service cost perspective and discounted at 3.5%/year . Results Coronary artery bypass grafting cost � 22 000 ( € 33 000 ; $ 43 000 ) per quality adjusted life year gained compared with percutaneous coronary intervention among patients appropriate for coronary artery bypass grafting only ( 59 % probability of being cost effective at a cost effectiveness threshold of � 30 000 per quality adjusted life year ) and � 19 000 per quality adjusted life year gained compared with medical management among those appropriate for both types of revascularisation ( probability of being cost effective 63 % ) . In none of the three appropriateness groups was percutaneous coronary intervention cost effective at a threshold of � 30 000 per quality adjusted life year . Among patients rated appropriate for percutaneous coronary intervention only , the cost per quality adjusted life year gained for percutaneous coronary intervention compared with medical management was � 47 000 , exceeding usual cost effectiveness thresholds ; in these patients , medical management was most likely to be cost effective ( probability 54 % ) . Conclusions Among patients judged clinical ly appropriate for coronary revascularisation , coronary artery bypass grafting seemed cost effective but percutaneous coronary intervention did not . Cost effectiveness analysis based on observational data suggests that the clinical benefit of percutaneous coronary intervention may not be sufficient to justify its cost CONTEXT Previous trials of off-pump coronary artery bypass ( OPCAB ) have enrolled selected patients and have not rigorously evaluated long-term graft patency . A preliminary report showed OPCAB achieved improved inhospital outcomes , similar completeness of revascularization , and shorter lengths of stay compared with conventional coronary artery bypass grafting ( CABG ) . OBJECTIVE To assess graft patency , clinical and quality -of-life outcomes , and cost among patients while in the hospital and at 1-year follow-up . DESIGN , SETTING , AND PATIENTS R and omized controlled trial of patients unselected for coronary anatomy , ventricular function , or comorbidities between March 10 , 2000 , and August 20 , 2001 , at a US academic center . A total of 200 patients were enrolled ; 3 patients were withdrawn after r and omization for mitral valve repair or replacement . Follow-up was complete for 197 patients at 30 days ; 185 at 1 year . INTERVENTIONS One surgical session consisting of elective OPCAB or CABG with cardiopulmonary bypass . The surgeon had extensive experience performing off-pump surgery ; patients were subsequently managed by blinded protocol s. MAIN OUTCOME MEASURES Coronary angiography documented graft patency prior to hospital discharge and at 1 year ; health-related quality of life ; and cost of the index and subsequent hospitalization(s ) . RESULTS Graft patency was similar for OPCAB and conventional CABG with cardiopulmonary bypass at 30 days ( absolute difference , 1.3 % ; 95 % confidence interval [ CI ] , -0.66 % to 3.31 % ; P = .19 ) and at 1 year ( absolute difference , -2.2 % ; 95 % CI , -6.1 % to 1.7 % ; P = .27 ) . Rates of death , stroke , myocardial infa rct ion , angina , and reintervention were similar at 30 days and 1 year . There were no significant differences in health-related quality of life . Mean total hospitalization cost per patient at hospital discharge was 2272 dollars ( 95 % CI , 755 dollars-3732 dollars ) less for OPCAB ( P = .002 ) and 1955 dollars ( 95 % CI , -766 dollars to 4727 dollars ) less at 1 year ( P = .08 ) . CONCLUSIONS In this r and omized single-surgeon trial among unselected patients with angiographic follow-up , OPCAB achieved similar graft patency in the hospital and at 1 year . Cardiac outcomes and health-related quality of life at 30 days and 1 year were similar and patients incurred a lower cost . OPCAB may provide complete revascularization that is durable and cost-effective BACKGROUND Limited prospect ively collected data are available on the total outcomes , cost estimates , and quality of life associated with treatment of acute coronary syndrome ( ACS ) through 1 year in a non clinical -trial setting , or on the impact of new clinical events by 1 year on re source utilization and costs . METHODS The Antiplatelet Therapy Observational Registry ( APTOR ) 12-month study followed 1,335 concurrently recruited ACS patients undergoing percutaneous coronary intervention ( PCI ) and treated with antiplatelet therapy from France , Spain , and the United Kingdom in a " real world " clinical setting . Data were collected on clinical events , re source utilization , quality of life , and cost estimates through 1-year follow-up . RESULTS By 1 year , 14.4 % ( 95 % CI 12.7 - 16.4 % ) of patients experienced a clinical event of death , MI , stroke , unstable angina , urgent target vessel revascularization , or acute heart failure . Costs by 1 year were higher among those who had a new clinical event ( £ 8,988 , 95 % CI £ 7,848 , £ 10,395 ) as compared with those with no events ( £ 5,809 , 95 % CI £ 5,486 , £ 6,161 ) . This increased cost was due to higher postdischarge re source use costs . Using the EQ-5D assessment at 1 year , quality of life was directionally lower in those patients who had experienced a new clinical event . CONCLUSIONS The risk of experiencing a new clinical event during the year following an ACS , which was treated with PCI , remains high among European patients , with one-seventh of patients having a new event . These additional clinical outcomes reduce quality of life and increase health care expenditures , exp and ing the already high cost of treatment for ACS Purpose To compare HRQoL differences with CHD in generic indexes and a proxy CVD-specific score in a nationally representative sample of U.S. adults . Methods The National Health Measurement Study , a cross-sectional r and om-digit-dialed telephone survey of adults aged 35–89 , administered the EQ-5D , QWB-SA , HUI2 , HUI3 , SF-36v2 ™ ( yielding PCS , MCS , and SF-6D ) , and HALex . Analyses compared 3,350 without CHD ( group 1 ) , 265 with CHD not taking chest pain medication ( group 2 ) , and 218 with CHD currently taking chest pain medication ( group 3 ) , with and without adjustment for demographic variables and comorbidities . Data on 154 patients from heart failure clinics were used to construct a proxy score utilizing generic items probing CVD symptoms . Results Mean scores differed between CHD groups for all indexes with and without adjustment ( P < 0.0001 for all except MCS P = 0.018 ) . Unadjusted group 3 versus 1 differences were about three times larger than for group 2 versus 1 . St and ardized differences for the proxy score were similar to those for generic indexes , and were about 1.0 for all except MCS for group 3 versus 1 . Conclusions Generic indexes capture differences in HRQoL in population -based studies of CHD similarly to a score constructed from questions probing CVD-specific symptoms AIMS Off-pump coronary bypass grafting ( OPCAB ) has short-term benefits compared to conventional bypass grafting using the heart-lung machine ( CABG-CPB ) but may compromise longer term outcome . We aim ed to compare generic and disease specific quality of life ( QoL ) two to four years after surgery in participants in two r and omised controlled trials of OPCAB vs. CABG-CPB . METHODS AND RESULTS Trial participants were sent four question naires ( SF-36 , EuroQol/EQ5D , Seattle Angina Question naire ( SAQ ) and Coronary Revascularisation Outcome Question naire ( CROQ ) ) to assess generic and disease-specific quality of life ( QoL ) . Of 401 participants , 22 ( 5.5 % ) had died ; of the 379 survivors , 328 responded ( 86.5 % ; 159 CABG-CPB and 169 OPCAB ) . Median duration of follow-up was three years . QoL scores for both groups were very similar and differences between groups were not significant ( p>0.05 for all question naires and dimensions ) . Summary SF-36 scores showed poorer than normal physical QoL but normal mental QoL. Among all responders , there was a tendency for CROQ scores ( core total , physical and psychosocial functioning and satisfaction with treatment ) to deteriorate with time after the operation ( p < or = 0.05 ) . CONCLUSION Two to four years after surgery , patients r and omised to OPCAB and CABG-CPB had similar symptoms , generic and disease-specific Background The SF-6D was derived from the SF-36 . A single summary score is obtained allegedly preserving the descriptive richness and sensitivity to change of the SF-36 into utility measurement . We compared the SF-6D and EQ-5D on domain content , scoring distribution , pre-treatment and change scores . Methods The SF-6D and the EQ-5D were completed prior to intervention and 1 , 3 , 6 and 12 months post-intervention in a study enrolling 561 patients with symptomatic coronary stenosis . Patients were r and omized to off-pump coronary artery bypass surgery ( CABG ) , st and ard on-pump CABG , or percutaneous transluminal coronary angioplasty ( PTCA ) . Baseline and change over time scores were compared using parametric and non-parametric tests . Results The relative contribution of similar domains measuring daily functioning to the utility scores differed substantially . SF-6D focused more on social functioning , while EQ-5D gave more weight to physical functioning . Pain and mental health had similar contributions . The scoring range of the EQ-5D was twice the range of the SF-6D . Before treatment , EQ-5D and SF-6D mean scores appeared similar ( 0.64 versus 0.63 , p = 0.09 ) . Median scores , however , differed substantially ( 0.69 versus 0.60 ) , a difference exceeding the minimal important difference of both instruments . Agreement was low , with an intra-class correlation of 0.45.Finally , we found large differences in measuring change over time . The SF-6D recorded greater intra-subject change in the PTCA-group . Only the EQ-5D recorded significant change in the CABG-groups . In the latter groups changes in SF-6D domains cancelled each other out . Conclusion Although both instruments appear to measure similar constructs , the EQ-5D and SF-6D are quite different . The low agreement and the differences in median values , scoring range and sensitivity to change after intervention show that the EQ-5D and SF-6D yield incomparable scores in patients with coronary heart disease Context National guidelines recommend aspirin or statin drugs individually to reduce first coronary heart disease ( CHD ) events , but there are no guidelines about taking both . Contribution The authors used a Markov model to estimate the cost-effectiveness of aspirin , statins , both drugs , or neither in men . In patients with a 10-year risk for CHD of 7.5 % , aspirin alone reduced costs and lengthened life compared with no treatment . Adding a statin cost $ 56200 per additional quality -adjusted life-year at a 7.5 % risk but only $ 42500 at a 10 % risk . Caution s The authors ' analysis was limited to men . Implication s Therapy with aspirin alone is effective and cost-effective in men with an average level of risk for CHD . The addition of a statin is more cost-effective as risk increases . The Editors Aspirin and statin drugs have been shown to be effective for preventing first coronary heart disease ( CHD ) events ( 1 - 3 ) . Systematic review s and meta-analyses suggest that the relative risk reductions with both forms of therapy are similar in magnitude and seem to be independent and relatively constant across the range of underlying risk for CHD ( 2 - 5 ) . The absolute benefit from these treatments seems to be proportional to the patient 's underlying risk for CHD . National treatment guidelines recommend aspirin and statin drugs individually for the primary prevention of cardiovascular events in men who are at increased risk ( 4 , 6 , 7 ) . However , no U.S. guidelines have addressed how these drugs should be used together , and we are unaware of any previous analyses that have reported the cost-effectiveness of these drugs when used in combination for CHD prevention . To help inform clinical and policy decisions about primary CHD prevention , we performed a costutility analysis that examined the use of aspirin therapy , statin therapy , or combination therapy with both drugs in men with various underlying levels of risk for CHD . Methods To examine the cost and utility associated with aspirin and with statin use , we used Microsoft Excel 2002 for Windows ( Microsoft Corp. , Redmond , Washington ) to develop a Markov state-transition model . The model was design ed to simulate cohorts of initially healthy middle-aged men with no history of cardiovascular events and with various levels of 10-year risk for CHD ( Figure 1 ) . Figure 1 . General structure of the Markov model . Base-Case Scenario In our base-case scenario , we compared the effectiveness of 10 years of aspirin therapy , statin therapy , combination therapy with both drugs , and no therapy in 45-year-old men with a 10-year risk for CHD of 7.5 % . After 10 years , both groups adopted the treatment used in the intervention group . Although the differences in therapy were maintained for only 10 years , we examined the effects of these therapies over a lifetime . Model Assumptions All persons were initially healthy and progressed through the model in annual cycles . In each cycle , an individual remained healthy , had an initial cardiovascular event ( angina , myocardial infa rct ion , or stroke ) , experienced adverse effects from therapy ( gastrointestinal bleeding from aspirin or myopathy from statins ) , or died . We assumed that those who had cardiovascular events or adverse events stayed in the subacute state for the remainder of that cycle and then entered a postevent state . Adherence to treatment was assumed to be 100 % in the absence of adverse effects , although the treatment efficacy data were based on the actual rates of adherence in the clinical trials . Persons who had adverse effects from therapy stopped taking the offending medication ; their procession through the model was similar to that of healthy patients after the initial cycle . All costs and outcomes were discounted at 3 % in accordance with current consensus recommendations ( 8) . Model Parameters Model parameters , including base-case values , ranges , and references , are shown in Table 1 ( 1 - 3 , 9 - 29 ) . Table 1 . Base-Case Estimates and Ranges Used in Sensitivity Analyses Noncardiovascular Mortality Age-dependent noncardiovascular mortality rates were estimated from the National Vital Statistics life tables ( 31 ) . Rates were adjusted as the cohort aged over the time horizon of the analysis . Cardiovascular Event Rates Baseline risks for initial cardiovascular events ( myocardial infa rct ion , stroke , angina , and death from CHD ) were drawn from Framingham risk equations by using hypothetical scenarios of nonsmoking , nonhypertensive , nondiabetic men at different levels of risk for CHD ( Appendix Table ) ( 32 ) . Assuming an exponential distribution , we translated these 10-year risks into annual event-related transition probabilities . These probabilities were allowed to change over time to reflect increasing risk for CHD over the time horizon of the analysis . Appendix Table . Sample Baseline Characteristics of 45-Year-Old Men by Risk Level Because we were interested in primary prevention , we did not simulate or examine the details of a patient 's course after a primary , nonfatal event . Instead , we assigned them an increased risk for death , increased costs , and decreased utilities by using data from the literature regarding the average experience of patients after an initial event . The increased relative risk for death after an initial event ( Table 1 ) was drawn from population -based studies in the United Kingdom ( 12 , 16 ) and applied to the general mortality rates from the U.S. life tables to generate the estimated postevent mortality rates . We modified these event rates by assuming that all patients received optimal secondary prevention . Adverse Effects The excess risks for gastrointestinal bleeding with aspirin use and for myopathy with statin use were drawn from systematic review s of r and omized trials and a recent secondary data analysis ( 2 , 26 , 27 ) . Risks for gastrointestinal bleeding and myopathy in untreated patients were assumed to be zero so that only treatment-induced adverse events were counted . Because better data were not available , we estimated the risks for death from aspirin-related gastrointestinal bleeding and statin-induced myopathy and varied them in sensitivity analysis . Patients who had nonfatal adverse effects were not given therapy with alternate agents for primary prevention of CHD . Modeling Stroke Because many r and omized trials of aspirin prophylaxis did not distinguish by stroke type , we had difficulty estimating the precise effect of aspirin on ischemic and hemorrhagic strokes ( 30 ) . To account for this limitation , we used 2 approaches to model the effect of aspirin on stroke . In the base-case analysis , we followed the approach that was used in a recent meta- analysis ( 9 ) by including hemorrhagic stroke and ischemic stroke together in 1 estimate of the effect of aspirin on total stroke ( relative risk for stroke with aspirin , 1.06 ) . In an alternate scenario , we modeled hemorrhagic stroke and ischemic stroke as separate health states . We assumed that aspirin was associated with an excess annual risk of 20 hemorrhagic strokes per 100000 users on the basis of published meta-analyses and that one third of these hemorrhagic strokes would be fatal ( 19 , 30 , 33 ) . We conservatively assumed that aspirin had no effect on ischemic stroke ( 30 ) . The costs and utilities of ischemic stroke and hemorrhagic stroke were also considered separately . Treatment Efficacy We used summary relative risk estimates from existing meta-analyses or relative risks from individual trials to estimate the efficacy of aspirin and statin therapy , either alone or in combination , for preventing CHD events ( 3 , 24 , 29 ) . Where data were limited , we made conservative assumptions . The efficacy of the combined use of aspirin and statins was assumed to be independent on the basis of data from secondary prevention trials ( 5 ) . We did not model the effect of aspirin or statins on initial use of revascularization procedures in the absence of a cardiovascular event . All patients who survived an initial cardiovascular event were assumed to have received secondary preventive therapy with aspirin and a statin or with an alternate agent if they could not tolerate aspirin or statins . The effect of treatments on all-cause mortality was estimated from meta-analyses of secondary prevention trials ( 18 - 20 ) . Costs We conducted our analysis from the perspective of a third-party payer . State costs ( Table 1 ) , which were derived from data from the published literature and several recent national data bases , are expressed in 2003 dollars . To estimate the costs during the year in which an event occurred , we estimated acute care costs by drawing on data regarding hospital charges from the Healthcare Utilization Project data base and by converting these values to costs . To convert hospital charges to costs , we used the 1999 cost-to-charge ratio value of 0.4501 , which was derived from the Medicare Provider Analysis and Review of short-stay hospitals ( 28 ) . We then used the Medical Consumer Price Index to generate an inflation factor of 1.195 , which was applied to the 1999 cost figure to convert 1999 dollars to 2003 dollars ( 17 ) . In addition to the acute care costs , we assumed that each patient who survived an acute event would also incur one half of the estimated ongoing annual costs of care for the first year . Costs for subsequent years were based on ongoing costs of care that were drawn from the medical literature ( 22 - 25 ) . Drug costs were obtained from the 2003 Red Book average wholesale prices ( 21 ) . For our base-case analysis , we set the annual statin cost to $ 730 by averaging the Red Book prices of simvastatin ( $ 922 for 10 mg/d ) and lovastatin ( $ 503 for 10 mg/d ) . The base-case cost of aspirin was based on an annual cost of $ 16 for Bayer aspirin ( Bayer Healthcare LLC , Morristown , New Jersey ) . The annual cost of generic aspirin was estimated at approximately $ 6 ( 21 ) . We varied the costs of each drug over wide ranges in sensitivity analysis . To check our cost estimates , we compared our derived values with other cost estimates The NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infa rct ion showed an improved clinical outcome with early transfer for percutaneous coronary intervention ( PCI ) compared to a more conservative approach after thrombolysis . The aim of this sub study was to compare the 12-month quality -adjusted life years ( QALYs ) and costs of these alternative strategies . Methods : Patients with ST-elevation myocardial infa rct ion < 6 h duration and > 90 min expected delay to PCI , received full-dose tenecteplase and were r and omized to either early or late invasive strategy ( n = 266 ) . Detailed quality of life and re source use data were registered prospect ively for a period of 12 months . Health outcomes were measured as quality of life using a generic instrument ( 15D ) . Quality of life scores were translated into QALYs . Unit costs were based on hospital accounts , fee schedules , and market prices . Results : After 12 months of follow-up , patients in the early invasive group had 0.008 ( 95 % CI −0.027 to 0.043 ) more QALYs compared to the late invasive group . The mean total costs were € 18,201 in the early versus € 17,643 in the late invasive group , with a mean difference of € 558 ( 95 % CI −2258 to 3484 ) . Cost/QALY was € 69,750 while cost/avoided clinical endpoint was € 5636 . Conclusion : Early and late invasive strategies after thrombolysis result ed in similar quality of life and similar costs in ST-elevation myocardial infa rct ion patients living far from a PCI centre ( NCT00161005 ) The Health Utilities Index Mark 3 ( HUI3 ) and the EuroQol EQ-5D ( EQ-5D ) were compared to each other and to other quality -of-life ( QoL ) measures in patients treated for intermittent claudication . A total of 88 patients with intermittent claudication completed the HUI3 , EQ-5D , R AND 36-Item Health Survey 1.0 , time tradeoff , st and ard gamble , and rating scale before revascularization and at follow-up at 1 month , 3 months , and 1 year . The effect of treatment on the HUI3 and EQ-5D dimensions and the overall scores , calculated using published formulas based on societal preferences , were compared . After 1 month of treatment , the majority of patients showed improvement on the HUI3 dimensions ambulation and pain and on the EQ-5D dimensions mobility , usual activities , and pain/discomfort . The mean HUI3 score was significantly higher than the mean EQ-5D score ( 0.66 and 0.57 , respectively , p < 0.01 ) before treatment . After treatment , however , they were not significantly different from each other ( e.g. , 12 months after treatment : 0.77 and 0.75 , respectively ( p > 0.05 ) . After 1 month , the scores did not change significantly over time ( p > 0.05 ) . The intraclass correlation coefficient between changes over time in the HUI3 and EQ-5D scores was 0.30 , with other health-related quality -of-life ( HRQoL ) measures the correlations for HUI3 and EQ-5D were very similar . In conclusion , both the HUI3 and EQ-5D demonstrated an effect of treatment in patients with intermittent claudication ; in addition , they showed similar relationships with other ( HRQoL ) measures . To demonstrate the effect of revascularization in patients with intermittent claudication , however , clinicians and research ers should be aware of the differences in the mean HUI3 and EQ-5D scores Background Since the late 1990s , cost pressure has led to a growing interest in outpatient rehabilitation in Germany where predominantly inpatient rehabilitation has been provided . Taking into account the feasibility of a r and omized design , the aim of this study was to compare outpatient and inpatient cardiac rehabilitation from a societal perspective . Method A comprehensive cohort design was applied . Costs during rehabilitation were measured using individual documentation of the rehabilitation centers . Economic end points were quality of life ( EQ-5D ) , and total direct and indirect costs . A propensity score approach , integrated into a simultaneous regression framework for cost and effects , was used to control for selection bias . Bootstrap analysis was applied for assessing uncertainty in cost-effectiveness . Results A total of 163 patients were included in the study ( 112 in patients , 51 out patients ) . As r and omization was chosen by only 2.5 % of participants , the study had to be analyzed as an observational study . Direct costs during inpatient rehabilitation were significantly higher by 600 € ( ±318 ; p < 0.001 ) compared to outpatient rehabilitation ( 2,016 € ± 354 € vs. 1,416 € ± 315 ) , while there was no significant difference in health-related quality of life . Over the 12-month follow-up period , adjusted costs difference in total cost was estimated at −2,895 € ( p = 0.102 ) and adjusted difference in effects at 0.018 quality -adjusted life years ( QALYs ) ( n.s . ) in favor of outpatient treatment . Conclusion The ratio of mean cost over mean effect difference ( incremental cost-effectiveness ratio ) indicates dominance of outpatient rehabilitation , but at a considerable statistical uncertainty . However , outpatient rehabilitation can not be rejected from an economic perspective BACKGROUND Previous studies have shown that among patients undergoing multivessel revascularization , coronary-artery bypass grafting ( CABG ) , as compared with percutaneous coronary intervention ( PCI ) either by means of balloon angioplasty or with the use of bare-metal stents , results in greater relief from angina and improved quality of life . The effect of PCI with the use of drug-eluting stents on these outcomes is unknown . METHODS In a large , r and omized trial , we assigned 1800 patients with three-vessel or left main coronary artery disease to undergo either CABG ( 897 patients ) or PCI with paclitaxel-eluting stents ( 903 patients ) . Health-related quality of life was assessed at baseline and at 1 , 6 , and 12 months with the use of the Seattle Angina Question naire ( SAQ ) and the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) . The primary end point was the score on the angina-frequency subscale of the SAQ ( on which scores range from 0 to 100 , with higher scores indicating better health status ) . RESULTS The scores on each of the SAQ and SF-36 subscales were significantly higher at 6 and 12 months than at baseline in both groups . The score on the angina-frequency subscale of the SAQ increased to a greater extent with CABG than with PCI at both 6 and 12 months ( P=0.04 and P=0.03 , respectively ) , but the between-group differences were small ( mean treatment effect of 1.7 points at both time points ) . The proportion of patients who were free from angina was similar in the two groups at 1 month and 6 months and was higher in the CABG group than in the PCI group at 12 months ( 76.3 % vs. 71.6 % , P=0.05 ) . Scores on all the other SAQ and SF-36 subscales were either higher in the PCI group ( mainly at 1 month ) or were similar in the two groups throughout the follow-up period . CONCLUSIONS Among patients with three-vessel or left main coronary artery disease , there was greater relief from angina after CABG than after PCI at 6 and 12 months , although the extent of the benefit was small . ( Funded by Boston Scientific ; Clinical Trials.gov number , NCT00114972 . ) AimS everal clinical trials have demonstrated the antianginal and anti-ischemic efficacy of ivabradine in combination with beta-blocker in patients with stable angina pectoris . The ADDITIONS ( PrActical Daily efficacy anD safety of Procoralan ® In combinaTION with betablockerS ) study evaluated the efficacy , safety , and tolerability of ivabradine added to beta-blocker , and its effect on angina symptoms and quality of life in routine clinical practice . Methods This non-interventional , multicenter , prospect i ve study included 2,330 patients with stable angina pectoris treated with a flexible dose of ivabradine twice daily in addition to beta-blocker for 4 months . The parameters recorded included heart rate , number of angina attacks , nitrate consumption , tolerance , and quality of life . Results After 4 months ivabradine ( mean dose 12.37 ± 2.95 mg/day ) reduced heart rate by 19.4 ± 11.4 to 65.6 ± 8.2 bpm ( p < 0.0001 ) . The number of angina attacks was reduced by 1.4 ± 1.9 per week ( p < 0.0001 ) , and nitrate consumption by 1.9 ± 2.9 U per week ( p < 0.0001 ) . At baseline ( i.e. , on beta-blocker ) , half of the patients ( 51 % ) were classified as Canadian Cardiovascular Society ( CCS ) grade II ; 29 % were CCS grade I. After 4 months ’ treatment with ivabradine , most of the patients were CCS grade I ( 68 % ) . The EQ-5D index improved by 0.17 ± 0.23 ( p < 0.0001 ) . The overall efficacy of ivabradine was considered by the physicians as “ very good ” ( 61 % ) or “ good ” ( 36 % ) in most patients . Suspected adverse drug reactions were documented in 14 patients ; none were severe . Conclusion In daily clinical practice , combining ivabradine with beta-blocker not only reduces heart rate , number of angina attacks , and nitrate consumption , but also improves the quality of life in patients with stable angina pectoris Objectives : To determine whether socioeconomic status ( SES ) influences clinical outcomes and quality of life after percutaneous coronary intervention ( PCI ) . Design : Prospect i ve observational study . Setting : Two interventional cardiac centres . Participants : 1346 consecutive patients undergoing PCI over a 12-month period . Outcomes : Self reported health-related quality of life ( HRQoL ; EuroQol-5 Dimensions ( EQ-5D ) ; EuroQol Visual Analogue Scale ( EQ-VAS ) ) , repeat angiography , revascularisation , hospital admission , myocardial infa rct ion and death within 12 months , by SES derived using postal address code . Main results : No significant differences were found between patients with high and low SES in the occurrence of repeat angiography ( p = 0.55 ) , repeat revascularisation ( PCI , p = 0.81 , CAEG , p = 0.27 ) , total cardiac hospitalisation ( p = 0.10 ) , myocardial infa rct ion ( p = 0.97 ) or death 12 months after PCI ( p = 0.88 ) . Non-procedure-related readmissions were higher in patients with low SES ( 18.6 % v 13.7 % ; p = 0.025 ) . After adjustment for confounding factors , patients with low SES had lower HRQoL scores at baseline ( 95 % CI for difference 0.01 to 0.14 ; p = 0.003 ) and at 12 months ( 95 % CI 0.07 to 0.17 ; p<0.001 ) compared with those with high SES . Conclusions : Clinical outcomes were similar for patients in different SES groups . Patients with low SES had considerably more non-procedure-related readmissions and lower quality -of-life scores . Future studies on HRQoL after coronary revascularisation should take account of these important differences related to SES OBJECTIVES We sought to compare the effects of an early interventional strategy ( IS ) versus a conservative strategy ( CS ) on health-related quality of life ( HRQOL ) in patients with non-ST-segment elevation acute coronary syndromes ( ACS ) . BACKGROUND The third R and omized Intervention Trial of unstable Angina ( RITA-3 ) evaluated early IS ( n = 895 ) versus CS ( n = 915 ) . We report one-year results of the RITA-3 trial concerning HRQOL . METHODS The patients ' HRQOL was assessed with the Short Form-36 ( SF-36 ) and Seattle Angina Question naire ( SAQ ) at four-month and one-year follow-up , and the EuroQOL Visual Analogue Scale ( EQ-VAS ) and EuroQOL 5-Dimensional Classification ( EQ-5D ) also measured at baseline . Analysis was performed using the two- sample t test and analysis of co-variance . RESULTS Mean changes from baseline EQ-VAS scores were better for IS than for CS at four months ( treatment difference of 3.0 , p < 0.001 ) and one year ( 2.3 , p < 0.01 ) . The EQ-5D utility scores were also higher for IS at four months ( treatment difference : 0.036 , p < 0.01 ) and at one year ( 0.016 , p = 0.20 ) . For SF-36 , IS scored significantly better at four months for physical function , physical role function , emotional role function , social function , vitality , and general health . The SAQ scores for exertional capacity , anginal stability and frequency , treatment satisfaction , and disease perception were better for IS at four months . These treatment differences were present but attenuated by one-year follow-up . Improvements in HRQOL for IS could be attributed to improvements in anginal symptoms . CONCLUSIONS In patients with non-ST-segment elevation ACS , an early IS provides greater gains in HRQOL , as compared with CS , mainly due to improvements in angina grade |
1,349 | 20,703,721 | Perception of the benefits of the innovation ( system usefulness ) was the most common facilitating factor , followed by ease of use .
Issues regarding design , technical concerns , familiarity with ICT , and time were the most frequent limiting factors identified . | null | null |
1,350 | 25,685,363 | There were no differences in all-cause mortality and non-significant differences in CHD mortality , result ing from the dietary interventions .
The reductions in mean serum cholesterol levels were significantly higher in the intervention groups ; this did not result in significant differences in CHD or all-cause mortality .
Dietary recommendations were introduced for 220 million US and 56 million UK citizens by 1983 , in the absence of supporting evidence from RCTs | OBJECTIVES National dietary guidelines were introduced in 1977 and 1983 , by the US and UK governments , respectively , with the ambition of reducing coronary heart disease ( CHD ) by reducing fat intake .
To date , no analysis of the evidence base for these recommendations has been undertaken .
The present study examines the evidence from r and omised controlled trials ( RCTs ) available to the US and UK regulatory committees at their respective points of implementation . | A common question in clinical consultations is : “ For this person , what are the likely effects of one treatment compared with another ? ” The central tenet of evidence based medicine is that this task is achieved by using the best evidence combined with consideration of that person 's individual needs.1 A further question then arises : “ What is the best evidence ? ” Two recent studies in the New Engl and Journal of Medicine have caused uproar in the research community by finding no difference in estimates of treatment effects between r and omised controlled trials and non-r and omised trials . The r and omised controlled trial and , especially , systematic review s of several of these trials are traditionally the gold st and ards for judging the benefits of treatments , mainly because it is conceptually easier to attribute any observed effect to the treatments being compared . The role of non-r and omised ( observational ) studies in evaluating treatments is contentious : deliberate choice of the treatment for each person implies that observed outcomes may be caused by differences among people being given the two treatments , rather than the treatments alone . Unrecognised confounding factors can always interfere with attempts to correct for identified differences between groups . These considerations have supported a hierarchy of evidence , with r and omised controlled trials and derivatives at the top , controlled QUESTIONS Does the PEDro scale measure only one construct ie , the method ological quality of clinical trials ? What is the hierarchy of items of the PEDro scale from least to most adhered to ? Is there any effect of year of publication of trials on item adherence ? Are PEDro scale ordinal scores equivalent to interval data ? DESIGN Rasch analysis of two independent sample s of 100 clinical trials from the PEDro data base scored using the PEDro scale . RESULTS Both sample s of PEDro data showed fit to the Rasch model with no item misfit . The PEDro scale item hierarchy was the same in both sample s , ranging from the most adhered to item r and om allocation , to the least adhered to item therapist blinding . There was no differential item functioning by year of publication . Original PEDro ordinal scores were highly correlated with transformed PEDro interval scores ( r = 0.99 ) . CONCLUSION The PEDro scale is a valid measure of the method ological quality of clinical trials . It is valid to sum PEDro scale item scores to obtain a total score that can be treated as interval level measurement and subjected to parametric statistical analysis A controlled intervention trial , with the purpose of testing the hypothesis that the incidence of coronary heart disease ( CHD ) could be decreased by the use of a serum-cholesterol-lowering ( SCL ) diet , was carried out in two mental hospitals near Helsinki in 1959 - 71 . The subjects were hospitalized middle-aged women . One of the hospitals received the SCL diet , ie a diet low in saturated fats and cholesterol and relatively high in poly-unsaturated fats , while the other served as the control with a normal hospital diet . Six years later the diets were reversed , and the trial was continued another six years . The use of the SCL diet was associated with markedly lowered serum cholesterol values . The incidence of CHD , as measured by the appearance of certain electrocardiographic patterns and by the occurrence of coronary deaths , was in both hospitals during the SCL-diet periods lower than during the normal-diet periods . The differences , however , failed to reach statistical significance . An examination of a number of potential confounding variables indicated that the changes in them were small and failed to account for the reduction in the incidence of CHD . Although the results of this trial do not permit firm conclusions , they support the idea that also among female population s the SCL diet exerts a preventive effect on CHD A controlled intervention trial , with the purpose of testing the hypothesis that the incidence of coronary heart disease ( CHD ) could be decreased by the use of serum-cholesterol-lowering ( SCL ) diet , was carried out in 2 mental hospitals near Helsinki in 1959 - -71 . The subjects were hospitalized middle-aged men . One of the hospitals received the SCL diet , i.e. a diet low in saturated fats and cholesterol and relatively high in polyunsaturated fats , while the other served as the control with a normal hospital diet . Six years later the diets were reversed , and the trial was continued another 6 years . The use of the SCL diet was associated with markedly lowered serum-cholesterol values . The incidence of CHD , as measured by the appearance of certain electrocardiographic patterns and by the occurrence of coronary deaths , was in both hospitals during the SCL-diet periods about half that during the normal-diet periods . An examination of a number of potential confounding variables indicated that the changes in them were small and failed to account for the considerable reduction in the incidence of CHD . It is concluded that the use of the serum-cholesterol-lowering diet exerted a substantial preventive effect on CHD |
1,351 | 26,299,472 | Although no treatment can be recommended on the basis of this review , improved outcomes were demonstrated with a number of agents including methotrexate , azathioprine , ciclosporin , rituximab , and intravenous immunoglobulin .
Plasmapheresis and leukapheresis were of no apparent benefit . | Dermatomyositis and polymyositis are rare chronic inflammatory disorders with significant associated morbidity and mortality despite treatment .
High-dose corticosteroids in addition to other interventions such as immunosuppressants , immunomodulators , and more recently , biologics are commonly used in clinical practice ; however , there are no clear guidelines directing their use .
Our objective was to systematic ally review the evidence for immunotherapy in the treatment of dermatomyositis and polymyositis . | BACKGROUND The therapeutic options for patients with polymyositis or dermatomyositis that is resistant to corticosteroids are limited , unproved , and often toxic . Uncontrolled trials concluded that both plasma exchange and leukapheresis are beneficial , but despite the considerable use of these approaches , proof of their efficacy is lacking . METHODS Thirty-nine patients with definite polymyositis or dermatomyositis were r and omly assigned to receive plasma exchange ( replacement of one volume of plasma with 5 percent albumin in saline ) , leukapheresis ( removal of 5 x 10(9 ) to 10 x 10(9 ) lymphocytes ) , or sham apheresis in a double-blind manner , with 12 treatments given over a one-month period . Muscle strength , functional capacity , and serum levels of muscle-associated enzymes were measured before and after the 12 procedures . RESULTS In each group 3 of 13 patients had improvements in strength and functional capacity . The condition of 3 patients treated with leukapheresis and 1 treated with plasma exchange deteriorated , and it was unchanged in the other 26 patients . Adverse effects of apheresis included the need for a central venous catheter ( 9 patients ) , major vasovagal episodes ( 3 patients ) , and severe citrate reactions ( 2 patients ) . Despite the occurrence of significant reductions in the serum levels of muscle enzymes with plasma exchange ( P less than 0.001 ) and significant decreases in lymphocyte counts with leukapheresis ( P = 0.002 ) , there were no significant differences among the three treatment groups in the final muscle strength or functional capacity of the patients . CONCLUSIONS As treatments for corticosteroid-resistant polymyositis or dermatomyositis , leukapheresis and plasma exchange are no more effective than sham apheresis BACKGROUND Dermatomyositis is a clinical ly distinct myopathy characterized by rash and a complement-mediated microangiopathy that results in the destruction of muscle fibers . In some patients the condition becomes resistant to therapy and causes severe physical disabilities . METHODS We conducted a double-blind , placebo-controlled study of 15 patients ( age , 18 to 55 years ) with biopsy-proved , treatment-resistant dermatomyositis . The patients continued to receive prednisone ( mean daily dose , 25 mg ) and were r and omly assigned to receive one infusion of immune globulin ( 2 g per kilogram of body weight ) or placebo per month for three months , with the option of crossing over to the alternative therapy for three more months . Clinical response was gauged by assessing muscle strength , neuromuscular symptoms , and changes in the rash . Changes in immune-mediated muscle abnormalities were determined by repeated muscle biopsies . RESULTS The eight patients assigned to immune globulin had a significant improvement in sores of muscle strength ( P < 0.018 ) and neuromuscular symptoms ( P < 0.035 ) , whereas the seven patients assigned to placebo did not . With crossovers a total of 12 patients received immune globulin . Of these , nine with severe disabilities had a major improvement to nearly normal function . Their mean muscle-strength scores increased from 74.5 to 84.7 , and their neuromuscular symptoms improved . Two of the other three patients had mild improvement , and one had no change in his condition . Of 11 placebo-treated patients , none had a major improvement , 3 had mild improvement , 3 had no change in their condition , and 5 had worsening of their condition . Repeated biopsies in five patients of muscles whose strength improved to almost normal showed an increase in muscle-fiber diameter ( P < 0.04 ) , an increase in the number and a decrease in the diameter of capillaries ( P < 0.01 ) , resolution of complement deposits on capillaries , and a reduction in the expression of intercellular adhesion molecule 1 and major-histocompatibility-complex class I antigens . CONCLUSIONS High-dose intravenous immune globulin is a safe and effective treatment for refractory dermatomyositis High-dose intravenous immunoglobulin ( IVIG ) therapy has been effective in treating various autoimmune and systemic inflammatory diseases . Here , we assessed the efficacy and safety of IVIG therapy with polyethylene glycol-treated human IgG ( drug code GB-0998 ) for patients with corticosteroid-refractory polymyositis ( PM ) and dermatomyositis ( DM ) by means of a r and omized , double-blind , placebo-controlled study . We r and omly assigned 26 subjects ( 16 PM and 10 DM ) to receive either GB-0998 or placebo . Intragroup comparison in the GB-0998 group showed statistically significant improvements due to GB-0998 administration in the primary endpoint ( manual muscle test score ) and secondary endpoints ( serum creatine kinase level and activities of daily living score ) . However , significant improvements were also found in the placebo group , and comparison of the GB-0998 group with the placebo group did not show any significant difference between the groups . We discuss possible reasons for the absence of a clear intergroup difference in efficacy . Nineteen adverse drug reactions were observed in 11 of 26 subjects ( 42.3 % ) , of which 2 events ( decreased muscle strength and increased serum creatine kinase ) were assessed as serious ; however , they are previously known events . These results indicate that GB-0998 can be safely used with the same pre caution s as other current IVIG therapy Objective . Ciclosporin and MTX are used in idiopathic inflammatory myopathies ( DM and PM ) when patients incompletely respond to glucocorticoids . Their effectiveness is unproved in r and omized controlled trials ( RCTs ) . We evaluated their benefits in a placebo-controlled factorial RCT . Methods . A 56-week multicentre factorial- design double-blind placebo-controlled RCT compared steroids alone , MTX ( 15–25 mg weekly ) plus steroids , ciclosporin ( 1–5 mg/kg/day ) plus steroids and all three treatments . It enrolled adults with myositis ( by Bohan and Peter criteria ) with active disease receiving corticosteroids . Results . A total of 359 patients were screened and 58 r and omized . Of the latter , 37 patients completed 12 months of treatment , 7 were lost to follow-up and 14 discontinued treatment . Patients completing 12 months of treatment showed significant improvement ( P < 0.001 on paired t-tests ) in manual muscle testing ( 14 % change ) , walking time ( 22 % change ) and function ( 9 % change ) . Intention to treat and completer analyses indicated that ciclosporin monotherapy , MTX monotherapy and ciclosporin/MTX combination therapy showed no significant treatment effects in comparison with placebo . Conclusion . Neither MTX nor ciclosporin ( by themselves or in combination ) improved clinical features in myositis patients who had incompletely responded to glucocorticoids . Trial Registration : International St and ard R and omized Controlled Trial Number Register ; http://www.controlled-trials.com/ ; IS RCT OBJECTIVES To test the utility of a new , easy to administer instrument for assessing activities of daily living in patients with amyotrophic lateral sclerosis ( ALS ) , to vali date its accuracy , and to assess its ability to record disease progression in patients with ALS against other functional scales , quantitative isometric muscle testing , and global assessment scales . DESIGN Serial assessment s of patients who presented to four ALS treatment centers in two multicenter studies . PATIENTS Study 1 ( cross-sectional ) evaluated 75 consecutive patients who presented to four ALS treatment centers during a 2-month period . Study 2 ( longitudinal ) evaluated the progression of 53 patients who were enrolled in a multicenter , phase I-II clinical trial of recombinant human ciliary neurotrophic factor for treatment of ALS . OUTCOME MEASURES The ALS Functional Rating Scale ( ALSFRS ) was compared with quantitative myometry and with other measures of daily function in patients with ALS both cross-sectionally and longitudinally . RESULTS The first study of 75 patients evaluated the internal consistency , the test-retest reliability , and the construct validity of the ALSFRS . Internal consistency and test-retest reliability were high . Patient self-rating of upper- and lower-extremity-dependent tasks were highly correlated with measures of upper- and lower-extremity strength , respectively . Thus , the ALSFRS has good construct validity . In the second study , ALSFRS scores declined in t and em with deterioration in motor and pulmonary function , indicating its sensitivity to change . CONCLUSIONS The ALSFRS is a useful instrument for evaluation of functional status and functional change in patients with ALS . Its results are in close agreement with objective measures of muscle strength and pulmonary function . The ALSFRS may be used as a screening measure for entry into clinical trials , as a surrogate measure of function in situations in which muscle strength can not be measured directly , or as an adjunct to myometry To determine if high-dose pulsed dexamethasone is more effective and safer than daily high-dose prednisolone in treatment-naive adult patients with inflammatory myopathies ( sporadic inclusion body myositis excluded ) we performed a multicenter , double-blind r and omised controlled clinical trial with 18 months follow-up . Sixty-two patients were r and omised into 28-day cycles of oral high-dose dexamethasone or daily high-dose prednisolone . Primary outcome measures included ( 1 ) seven point composite score of six clinical ly relevant outcomes and ( 2 ) ( time-to ) remission and ( time-to ) relapse . No difference between both treatment groups on the composite score was found . Side-effects occurred significantly less frequently in the dexamethasone group . Median time to relapse was 60 ( 2.9 ) weeks in the prednisolone and 44 ( 4.7 ) weeks in the dexamethasone group ( log-rank test p=0.03 ) . In conclusion , pulsed high-dose oral dexamethasone is not superior to daily prednisolone as first-line treatment of idiopathic inflammatory myopathies , but is a good alternative by causing substantially fewer side-effects Two groups of patients with polymyositis have been followed for approximately 3 years . One group was treated with prednisone alone and the other with prednisone plus azathioprine . Although the polymyositis of both groups has improved , no statistically significant difference was noted at the end of 3 months , as previously reported . Longer followup , however , has shown that the group given prednisone plus azathioprine has improved more with respect to functional disability ; this group also requires less prednisone for disease control A controlled , prospect i ve , double-blind , therapeutic trial of azathioprine was conducted in the initial therapy of polymyositis . Sixteen patients received 60 mg prednisone per day plus either azathioprine ( 2 mg/kg of body weight per day ) or placebo for a period of 3 months . Creatine phosphokinase ( CPK ) levels fell to normal slightly sooner in the placebo group , but not significantly so . The azathioprine group did not become significantly stronger ( P = 0.58 ) and did not manifest significantly greater improvement of histopathologic features of muscle ( P = 0.80 ) than the placebo group . Initial CPK elevations were significantly related to the degree of muscle inflammation ( P = 0.037 ) , but this was not the case at 3 months ( P greater than 0.05 ) . Normalization of the CPK could not be equated with disease control . Type II fiber atrophy , attributed to steroid therapy , was more marked in women than in men ( P less than 0.03 ) OBJECTIVE To assess the safety and efficacy of rituximab in a r and omized , double-blind , placebo-phase trial in adult and pediatric myositis patients . METHODS Adults with refractory polymyositis ( PM ) and adults and children with refractory dermatomyositis ( DM ) were enrolled . Entry criteria included muscle weakness and ≥2 additional abnormal values on core set measures ( CSMs ) for adults . Juvenile DM patients required ≥3 abnormal CSMs , with or without muscle weakness . Patients were r and omized to receive either rituximab early or rituximab late , and glucocorticoid or immunosuppressive therapy was allowed at study entry . The primary end point compared the time to achieve the International Myositis Assessment and Clinical Studies Group preliminary definition of improvement ( DOI ) between the 2 groups . The secondary end points were the time to achieve ≥20 % improvement in muscle strength and the proportions of patients in the early and late rituximab groups achieving the DOI at week 8 . RESULTS Among 200 r and omized patients ( 76 with PM , 76 with DM , and 48 with juvenile DM ) , 195 showed no difference in the time to achieving the DOI between the rituximab late ( n = 102 ) and rituximab early ( n = 93 ) groups ( P = 0.74 by log rank test ) , with a median time to achieving a DOI of 20.2 weeks and 20.0 weeks , respectively . The secondary end points also did not significantly differ between the 2 treatment groups . However , 161 ( 83 % ) of the r and omized patients met the DOI , and individual CSMs improved in both groups throughout the 44-week trial . CONCLUSION Although there were no significant differences in the 2 treatment arms for the primary and secondary end points , 83 % of adult and juvenile myositis patients with refractory disease met the DOI . The role of B cell-depleting therapies in myositis warrants further study , with consideration for a different trial design OBJECTIVE To determine the effectiveness and tolerance of treatment with cyclosporine A ( CyA ) or methotrexate ( MTX ) added to corticosteroids in patients with severe , active polymyositis ( PM ) and dermatomyositis ( DM ) . PATIENTS AND METHODS Thirty-six patients ( 20 with DM , 16 with PM ) were enrolled into the study and r and omized in MTX ( n = 17 ) and CyA ( n = 19 ) groups . Muscle endurance and functional test ( MEFT ) , clinical assessment ( CA ) , global patient 's assessment ( GPA ) , muscle MRI , serum CK , myoglobin , IL-1Ra , and autoantibody status were used to assess the response to therapy after 1 , 3 , and 6 months . RESULTS Significant improvement in MEFT , CA , GPA , and muscle MRI was found in both groups . Patients treated with MTX showed insignificantly better response than patients with CyA. CK levels in the MTX group decreased significantly after 1 , 3 , and 6 months , whereas a significant reduction in the CyA group was first observed after 6 months . IL-1Ra serum levels significantly dropped in the CyA group after two weeks , whereas in the MTX group the significant decrease was first seen after 3 months of treatment . Good correlation was found between each of the clinical parameters ( MEFT , CA , and GPA ) , none of them showed any correlation with CK or IL-1Ra levels . CONCLUSIONS Administration of MTX or CyA added to corticosteroids was associated with clinical and laboratory improvement . Changes in CK and IL-1Ra levels were not associated with parameters of clinical disease severity measured in this study OBJECTIVE To assess the clinical usefulness of 2 novel therapies for treatment-resistant myositis . METHODS Thirty patients with refractory myositis , of whom 25 had an inadequate or no response to previous cytotoxic therapy , were r and omized to begin either a combination of weekly oral methotrexate and daily azathioprine ( MTX/AZA ) or intravenous methotrexate with leucovorin rescue ( I.V. MTX ) every 2 weeks for 6 months . Crossover to the alternate therapy occurred according to defined rules ; evaluations of muscle strength and functional abilities were performed at the beginning , and after 3 and 6 months , of each treatment . RESULTS Of the 15 patients initially r and omized to oral MTX/AZA , 8 improved with oral therapy and 1 improved with I.V. MTX during the crossover period . Of the 15 patients initially r and omized to I.V. MTX therapy , 3 improved with the I.V. therapy and 4 with the oral combination during the crossover period . Although the study lacked the power to directly compare both treatments , intention-to-treat analysis showed a trend in favor of those patients who first received oral combination therapy ( P = 0.025 ) . There were 0.09 adverse events per patient-month with oral combination therapy and 0.16 per patient-month with I.V. therapy ( P = 0.09 ) . CONCLUSION Combination oral MTX/AZA may benefit patients with treatment-resistant myositis , including those who previously had inadequate responses to either MTX or AZA alone . I.V. MTX with leucovorin rescue may also benefit some patients with refractory myositis |
1,352 | 11,972,932 | The review found moderately strong evidence that : ( 1 ) provider referral alone , or the choice between patient and provider referral , when compared with patient referral among patients with HIV or any STD , increases the rate of partners presenting for medical evaluation ; ( 2 ) contract referral , when compared with patient referral among patients with gonorrhoea , results in more partners presenting for medical evaluation ; ( 3 ) verbal , nurse-given health education together with patient-centred counselling by lay workers , when compared with st and ard care among patients with any STD , results in small increases in the rate of partners treated . | This review compares the effects of various sexually transmitted disease ( STD ) partner-notification strategies . | BACKGROUND We sought to compare two methods of notifying sex partners of subjects infected with the human immunodeficiency virus ( HIV ) or persons who had shared needles with them ( needle-sharing partners ) : " patient referral , " in which the responsibility for notifying partners was left to the patient , and " provider referral , " in which providers attempted to notify partners . METHODS Names of sex partners and needle-sharing partners and information on how to locate them were obtained from consenting HIV-infected subjects identified in the HIV-testing programs at three public health departments in North Carolina . The subjects were r and omly assigned to a patient-referral group ( in which patients had the initial responsibility for notifying their partners ) or a provider-referral group ( in which the study counselor notified the partners ) . The success of attempts to notify partners was monitored by means of interviews with counselors conducted both in the field and at the health department . RESULTS Of 534 HIV-positive persons identified at the health departments , 247 ( 46 percent ) did not return for counseling after the test , 8 were counseled outside the study , and 117 ( 22 percent ) were ineligible . Of the 162 invited to participate , 88 ( 54 percent ) declined and 74 ( 46 percent ) agreed . The subjects were mostly male ( 69 percent ) , black ( 87 percent ) , homosexual or bisexual ( 76 percent of the men ) , and had a median age of 30 years . Thirty-nine were assigned to the provider-referral group and 35 to the patient-referral group . In the provider-referral group 78 of 157 partners ( 50 percent ) were successfully notified , whereas in the patient-referral group only 10 of 153 ( 7 percent ) were notified . Of the partners notified by the counselors , 94 percent were not aware that they had been exposed to HIV . Overall , 23 percent of the partners notified and tested were HIV-positive . CONCLUSIONS In this trial , leaving the notification of partners up to the subjects ( patient referral ) was quite ineffective , despite the North Carolina law requiring that partners be notified . Partner notification by public health counselors ( provider referral ) was significantly more effective . Although the effectiveness of notification procedures is constrained by the accuracy of the information provided by HIV-infected patients , counselors who notify the partners of an infected patient can refer them to educational , medical , and support services targeted to persons at high risk for HIV infection and may encourage the adoption of less risky behavior OBJECTIVE This analysis describes the Outreach-Assisted Model of Partner Notification , an innovative strategy for encouraging seropositive injecting drug users ( IDUs ) to inform their partners of shared human immunodeficiency virus ( HIV ) exposure . The analysis focuses on two core components of the notification process : the identification of at-risk partners and preferences for self-tell vs. outreach assistance in informing partners of possible exposure to the virus . METHODS Using community outreach techniques , 386 IDUs were recruited for HIV pretest counseling , testing , and partner notification over a 12-month period . Of these , 63 tested HIV seropositive , and all but three returned for their test results . The 60 who were informed of their serostatus were r and omly assigned to either a minimal or an enhanced intervention condition . Participants assigned to the minimal ( self-tell ) group were strongly encouraged to inform their partners of possible exposure . Those assigned to the enhanced ( outreach-assisted ) group had the option of either informing one or more of their partner(s ) themselves or choosing to have the project 's outreach team do so . RESULTS Together , the 60 index persons who received their results provided names or at least one piece of locating information for a total of 142 partners with whom they perceived having shared possible exposure to the virus within the past five years . By itself , drug use accounted for half of all partners named . Sexual behavior alone accounted for 25 % of named partners . Eighty-two percent of the enhanced group preferred to have the outreach team tell at least one partner ; the team was requested to notify 71 % of the total number of partners whom this group named . CONCLUSIONS Findings suggest that IDUs want to notify their partners of shared HIV exposure . Outreach assistance was the preferred mode in the majority of cases . Exp and ing traditional community-based HIV outreach activities to include delivering street-based counseling , test , a partner notification appears to be a positive and workable prevention strategy Urogenital infections with Chlamydia trachomatis are widespread and usually asymptomatic . Major complications from infection include ectopic pregnancies and female infertility.1 Although contact tracing reduces the prevalence of chlamydia infection,2 the test rate among partners is often low , partly because male contacts have to have a urethral swab taken by a doctor . As the polymerase chain reaction can successfully detect infection in urine sample s,3 we investigated whether the test rate could be increased by asking the male contacts of infected women to send a urine sample directly from home to a laboratory instead of having a doctor take a urethral swab . Ninety six women with C trachomati s infection seen in general practice s in Aarhus County , Denmark , were r and omly divided according to their date of birth into an intervention group ( 45 patients ) and a Objective : To determine the cost and effectiveness of three approaches to partner notification for infectious syphilis . Study Design : People with syphilis were r and omly assigned to : ( 1 ) notification of partners by patients themselves within 2 days or disease intervention specialists would notify them ; ( 2 ) immediate notification by intervention specialist ; or ( 3 ) immediate notification by intervention specialists , who had the option of drawing blood in the field . Costs of intervention specialists ' time , travel , and overhead were measured . Intention‐to‐treat analysis measured outcomes per r and omized index patient . Results : From December , 1990 through March , 1993 , 1,966 index patients with syphilis ( primary 9 % ; secondary 18 % ; and early latent 73 % ) were r and omized in Broward County ( Ft . Lauderdale ) , Florida ( 1,191 ) ; Tampa , Florida ( 569 ) ; and Paterson , New Jersey ( 206 ) . Index patients reported 11,272 potentially exposed partners and sufficient information to initiate investigations for 2,761 . Of these , 2,236 were located , 367 had newly identified infections , and 870 others received preventive treatment . The three partner notification approaches had similar success locating partners ( 1.1–1.2 per index patient ) and treating partners ( 0.61–0.67 per index ) . The cost was $ 317 to $ 362 per partner treated ; the optimal strategy differed by study site . Conclusions : Partner notification identified many infected and potentially infected people . The cost and effectiveness of the three types of provider notification were similar . Alternative approaches are needed to reach infected partners who could not be notified Background : Sexually transmitted diseases ( STD ) are a major health problem in Zambia . Partner notification , which is a recommended strategy to decrease STD , must be improved . Goal : To assess whether individual counseling of patients with STD , combined with contact slip(s ) , had any impact on the proportion of sex partners traced in an urban setting in Zambia . Study Design : A r and omized trial comprised of 94 women and 302 men with STD . Results : Women and men in the intervention group informed more partners than did those in the control group . In the intervention group , 1.8 partners per man was treated compared to 1.2 in the control group ( P < 0.001 ) . There was no difference between the two groups of women . There was a gradual decline from numbers of partners informed to numbers of partners treated according to the patient to number of contact slips filed . Conclusions : Individual counseling of men with STD improved partner notification Introduction Gonorrhea has emerged recently as an epidemic disease of major proportions in the United States , with more than one million cases reported to state and local health departments in 1975.1 True incidence is unknown , but significant under-reporting is likely . A control program facing over a million cases per year must choose the general focus and specific techniques that best utilize its limited re sources . Except in some special geographic areas , interviewing and contact investigation of a significant proportion of the infected population appears to be an insurmountable task . Our purpose was to examine the efficacy of an alternative to the st and ard case interview and investigation . Although we recognized from the outset that a short-term evaluation could not provide data on disease control , we were able to evaluate the ability of the alternative to detect new cases , and on that basis we developed a sense of its comparative effectiveness and cost The impact of a ten-minute , soap opera-style videotape on knowledge and treatment behavior of black men with gonorrhea was tested in r and omized clinical trials . The videotape , shown to individual patients after diagnosis , produced a sizeable increase in the percentage of patients who returned for their test-of-cure examination : while only 43.3 % of control group patients returned , 53.5 % of those in the videotape group did so ; chi 2(1 ) = 9.0 ; P less than 0.003 . In a follow-up study , similar results were found : videotape group ( 59.0 % ) , control group ( 39.1 % ) ; chi 2(1 ) = 6.2 ; P less than 0.015 . The videotape also produced large , significant increases in patient knowledge , as measured by a test administered during patients ' clinic visit ( P less than 0.0001 ) . No measureable effect of the videotape was detected on patients ' willingness to refer sexual contacts for treatment . The findings suggest that clinic-based educational material s , particularly soap opera-style videotapes that engender audience identification , create emotional significance for the viewer , and model requisite communication skills , may have a significant role to play in control of sexually transmitted diseases |
1,353 | 25,806,713 | XELOX + B and FOLFOX + B are active combinations as first-line treatment of advanced CRC .
Both the XELOX + B and the FOLFOX + B arms represent 2 of the cornerstone combinations when B is used as first-line therapy | OBJECTIVES Oxaliplatin and either capecitabine or infusional/bolus 5-fluorouracil (5FU)-based chemotherapy + bevacizumab ( XELOX + B and FOLFOX + B ) represent 2 of the approved first-line treatments for advanced colorectal cancer ( CRC ) .
However , the addition of B did not offer a survival benefit compared with FOLFOX/XELOX alone in the phase III , NO16966 trial .
The aim of this review was to aggregate all published data on the efficacy of XELOX and FOLFOX-B in prospect i ve and retrospective studies as first-line therapy for stage IV CRC . | PURPOSE To compare the efficacy of cediranib ( a vascular endothelial growth factor receptor tyrosine kinase inhibitor [ VEGFR TKI ] ) with that of bevacizumab ( anti-VEGF-A monoclonal antibody ) in combination with chemotherapy as first-line treatment for advanced metastatic colorectal cancer ( mCRC ) . PATIENTS AND METHODS HORIZON III [ Cediranib Plus FOLFOX6 Versus Bevacizumab Plus FOLFOX6 in Patients With Untreated Metastatic Colorectal Cancer ] had an adaptive phase II/III design . Patients r and omly assigned 1:1:1 received mFOLFOX6 [ oxaliplatin 85 mg/m(2 ) and leucovorin 400 mg/m(2 ) intravenously followed by fluorouracil 400 mg/m(2 ) intravenously on day 1 and then continuous infusion of 2,400 mg/m(2 ) over the next 46 hours every 2 weeks ] with cediranib ( 20 or 30 mg per day ) or bevacizumab ( 5 mg/kg every 14 days ) . An independent end-of-phase II analysis concluded that mFOLFOX6/cediranib 20 mg met predefined criteria for continuation ; subsequent patients received mFOLFOX6/cediranib 20 mg or mFOLFOX6/bevacizumab ( r and omly assigned 1:1 ) . The primary objective was to compare progression-free survival ( PFS ) . RESULTS In all , 1,422 patients received mFOLFOX6/cediranib 20 mg ( n = 709 ) or mFOLFOX6/bevacizumab ( n = 713 ) . Primary analysis revealed no significant difference between arms for PFS ( hazard ratio [ HR ] , 1.10 ; 95 % CI , 0.97 to 1.25 ; P = .119 ) , overall survival ( OS ; HR , 0.95 ; 95 % CI , 0.82 to 1.10 ; P = .541 ) , or overall response rate ( 46.3 % v 47.3 % ) . Median PFS and OS were 9.9 and 22.8 months for mFOLFOX6/cediranib and 10.3 and 21.3 months for mFOLFOX6/bevacizumab . The PFS upper 95 % CI was outside the predefined noninferiority limit ( HR < 1.2 ) . Common adverse events with more than 5 % incidence in the cediranib arm included diarrhea , neutropenia , and hypertension . Cediranib-treated patients completed fewer chemotherapy cycles than bevacizumab-treated patients ( median 10 v 12 cycles ) . Patient-reported outcomes ( PROs ) were significantly less favorable in cediranib-treated versus bevacizumab-treated patients ( P < .001 ) . CONCLUSION Cediranib activity , in terms of PFS and OS , was comparable to that of bevacizumab when added to mFOLFOX6 ; however , the predefined boundary for PFS noninferiority was not met . The cediranib safety profile was consistent with previous studies but led to less favorable PROs compared with bevacizumab . Investigation of oral TKIs in CRC continues BACKGROUND A week on/week off capecitabine schedule with oxaliplatin/bevacizumab was evaluated in patients with metastatic colorectal cancer ( mCRC ) . PATIENTS AND METHODS Forty patients were required . The projected median progression-free survival ( PFS ) was 12 months ( 81 % power , 1-sided level 0.1 log-rank test ) . Capecitabine dose was 2500 mg/m(2)/day on days 1 - 7 ( n = 11 ) and was increased to 3000 mg/m(2)/day ( n = 29 ) in combination with oxaliplatin ( 85 mg/m(2 ) ) and bevacizumab ( 5 mg/kg ) . Cycles were repeated every 2 weeks . RESULTS Patient characteristics included Eastern Cooperative Oncology Group ( ECOG ) performance status 0 ( n = 24 ) or 1 ( n = 15 ) ; median age of 62 years ( range , 38 - 81 years ) . Median cycles administered were 7 ( range , 125 ) , corresponding to 3.5 months ' treatment duration . Pertinent grade 3/4 toxicities seen were diarrhea ( 18 % ) , h and -foot syndrome ( 10 % ) , and peripheral neuropathy ( 10 % ) . Bowel perforation in 1 patient ( 3 % ) and 1 death due to a cerebral hemorrhage ( 3 % ) were noted . Response rate ( RR ) was 38 % ( 1 complete and 14 partial responses ) . Median PFS was 8.6 months ( 95 % confidence interval [ CI ] , 4.7 - 10.2 months ) . Median overall survival was 17.2 months ( 95 % CI , 10.4 - 24.2 months ) . CONCLUSION The first US experience of capecitabine to our knowledge ( 3000 mg/m(2 ) on days 1 - 7 ) in combination with oxaliplatin/bevacizumab in mCRC does not appear to have advantages compared with current st and ard first-line mCRC treatment regimens Purpose The addition of bevacizumab to oxaliplatin-based chemotherapy significantly improved progression-free survival ( PFS ) in patients with metastatic colorectal cancer ( CRC ) . An increased risk of arterial thromboembolic events has been observed in some trials in older patients , and the potential benefit of a maintenance therapy with bevacizumab alone has not been clearly demonstrated . This phase II study was design ed to evaluate the efficacy and safety of XELOX ( capecitabine plus oxaliplatin ) plus bevacizumab followed by bevacizumab alone in elderly patients with advanced CRC . Methods Treatment consisted of bevacizumab 7.5 mg/kg and oxaliplatin 130 mg/m2 on day 1 , plus capecitabine 1,000 mg/m2 twice daily on days 1–14 , every 3 weeks up to a maximum of 8 cycles . Patients then received maintenance therapy consisting of bevacizumab alone ( 7.5 mg/kg ) once every 3 weeks up to disease progression . The primary study end-points were safety and response rate . Results A total of 44 patients were recruited . In an intention-to-treat analysis , the overall response rate was 52 % [ 95 % confidence interval ( CI ) 37 to 68 % ] , with 86 % of patients achieving disease control . Median PFS and overall survival were 11.5 months ( 95 % CI 10.0–12.9 months ) and 19.3 months ( 95 % CI 16.5–22.1 months ) , respectively . In all , 10 patients ( 23 % ) had grade 3/4 adverse events ( AEs ) , the most common being diarrhea ( 9 % ) , neutropenia ( 7 % ) , peripheral neuropathy ( 7 % ) , and stomatitis ( 7 % ) . No patients died because of treatment-related AEs . The rate of bevacizumab-related AEs ( hypertension , thromboembolic events , and gastrointestinal perforation ) was consistent with that reported earlier in the general CRC population . Conclusion The combination of XELOX and bevacizumab is effective and has a manageable tolerability profile when administered to elderly patients with advanced CRC . Maintenance therapy with single-agent bevacizumab may be considered to extend PFS in this setting of patients Summary Purpose To assess safety and efficacy of folinic acid , 5-fluorouracil , gemcitabine ( FFG ) and folinic acid , fluorouracil , oxaliplatin ( FOLFOX4 ) regimens with added bevacizumab as first-line treatment in patients with advanced colorectal cancer ( CRC ) . Patients and Methods Patients with Stage III unresectable or Stage IV adenocarcinoma of the colon or rectum were r and omly assigned to either FFG weekly for 6 weeks of an 8-week cycle or FOLFOX4 every 2 weeks . After FDA approval , bevacizumab 5 mg/kg was added every 2 weeks . Treatment continued until disease progression . Planned enrollment was 190 patients . Primary endpoint was overall response rate ( ORR ) ; secondary endpoints included evaluation of adverse events , time to progression ( TTP ) , and overall survival ( OS ) . Disease Control Rate ( DCR ; % of patients with complete or partial responses or stable disease ) was a post hoc analysis . Results The trial was stopped prematurely due to low enrollment . Of 84 enrolled patients ( 42 to each arm ) , 36 patients ( 18 in each arm ) received bevacizumab . ORR was greater ( P = .002 ) for FOLFOX4 ( 17/42 ; 40.5 % ) than for FFG ( 4/42 ; 9.5 % ) ; however , TTP , OS , and DCR results were not statistically different comparing FOLFOX4 and FFG . Peripheral neuropathy was more frequent ( P = < .001 ) with FOLFOX4 ( 18/42 ; 42.9 % ) than with FFG ( 1/42 ; 2.4 % ) . Conclusions FFG and FOLFOX4 were generally well tolerated . Based on ORR , FOLFOX4 was superior to FFG . However , differences in TTP and OS comparing regimens were inconclusive . General use of gemcitabine as a biomodulator of 5-fluorouracil in CRC can not be recommended at this time and the regimen remains investigational BACKGROUND Cetuximab ( C ) , alone or with irinotecan , demonstrates activity in irinotecan-refractory colorectal cancer ( CRC ) . Activity of 5-fluorouracil ( 5-FU ) , leucovorin ( L ) , and bevacizumab ( B ) , and preliminary data of cetuximab + bevacizumab , and toxicity profiles suggests that FOLF-CB ( 5-FU , L , C+B ) may have activity with a favorable toxicity profile as first-line therapy . METHODS Eligible patients were r and omized at registration to either arm A ( mFOLFOX6-B ) ( modified , 5-FU . L ( folinic acid ) , oxaliplatin ( O ) + bevacizumab ) , administered days 1 and 15 of each 28-day cycle as bevacizumab 5 mg/kg , oxaliplatin 85 mg/m(2 ) , leucovorin 400 mg/m(2 ) , and 5-FU 400 mg/m(2 ) then 1200 mg/m(2)/day for 48 hours , or arm B ( FOLF-CB ) , which included bevacizumab , leucovorin , and 5-FU as in arm A and cetuximab 400 mg/m(2 ) day 1 cycle 1 ; all other weekly cetuximab doses were 250 mg/m(2 ) . RESULTS Two hundred forty-seven patients ( arm A/arm B 124/123 ) were enrolled , and 239 were treated ( 118/121 ) . Twelve-month progression-free survival ( PFS ) was 45%/32 % , objective response rates ( ORR ) ( complete response [ CR ] + partial response [ PR ] ) were 52%/41 % , disease control rates ( CR+PR+stable disease [ SD ] ) were 87%/83 % , and median overall survival ( OS ) was 21/19.5 months , respectively . Grade 3 - 4 neutropenia was higher in arm A ( 28%/7 % ) , as was grade 3 fatigue ( 12%/3 % ) , and grade 3 neuropathy ( 11%/ < 1 % ) , whereas acneiform rash was confined to arm B. Retrospective analysis of KRAS mutational status did not demonstrate KRAS as a meaningful determinant of activity , except in arm B patients with KRAS-mutated tumors , which result ed in inferior PFS . Patient satisfaction favored the control ( mFOLFOX6-B ) . CONCLUSION FOLF-CB was not superior to mFOLFOX6-B in terms of 12-month PFS and ORR , and was not more acceptable to patients . This trial supports the conclusion of other recently reported trials that concurrent cetuximab+bevacizumab should not be routinely used in metastatic CRC |
1,354 | 21,777,090 | Psychological interventions ( especially cognitive behavioural stress management interventions and cognitive behavioural therapy ) were generally more effective than pharmacological interventions .
Our detailed data suggest that interventions are both effective and available , although further research into enhancing efficacy would be valuable . | People with human immunodeficiency virus ( HIV ) show elevated anxiety levels compared to the general population .
Anxiety can pre date HIV infection or be triggered by HIV diagnosis and the many stresses that emerge during the course of HIV disease .
Many psychological and pharmacological therapies have been shown to treat anxiety in the general population but a systematic underst and ing of which interventions have been tested in and are effective with HIV-seropositive individuals is needed .
This review examines all published intervention studies on anxiety and HIV from 1980 to 2009 covered by the data bases MedLine ( 1980 - 2009 ) and PsycINFO ( 1980 - 2009 ) for a definitive account of effectiveness of interventions and an indication of prevalence of HIV-related anxiety and measurement within studies . | Objective This r and omized clinical trial was design ed to compare the effects of a theory-based coping effectiveness training ( CET ) intervention with an active informational control ( HIV-Info ) condition and a waiting-list control ( WLC ) condition on psychological distress and positive mood in HIV-seropositive gay men . Material s and Methods The authors recruited 149 self-identified gay or bisexual men who were 21 to 60 years of age , reported depressed mood , and had CD4 levels of 200 to 700 cells/mm3 . CET and HIV-Info participants attended 10 90-minute group sessions during the 3-month intervention phase and six maintenance sessions over the remainder of the year . Participants were assessed at baseline and at 3 , 6 , and 12 months . Data were collected 1992 to 1994 , before the introduction of HAART . Analyses were based on the 128 participants who completed the 3-month assessment . Results After the 3-month intervention phase , when compared with HIV-Info , CET participants showed significantly greater decreases in perceived stress and burnout , and regression analyses indicated that significant increases in coping self-efficacy mediated the improvements in perceived stress and burnout . Compared with WLC , CET participants also showed significantly greater decreases in anxiety , and regression analyses indicated that significant increases in positive states of mind mediated the improvements in anxiety . Significant treatment group differences for positive morale were maintained at 6 and 12 months . In addition , optimism continued to increase in the CET and HIV-Info treatment groups during the maintenance phase . Conclusions CET can be an effective strategy for managing psychological distress and improving positive psychological states in patients confronting chronic illness Mounting evidence suggests that smokers living with HIV/AIDS have a significantly increased risk of numerous adverse health outcomes ( both AIDS- and non-AIDS-related ) compared with HIV-positive nonsmokers . Therefore , efforts to design and implement effective cessation programs for this ever-growing special population are warranted . The present study assessed the effects of a cell phone intervention ( CPI ) on hypothesized mediators ( i.e. , changes in depression , anxiety , social support , and self-efficacy ) demonstrated to influence cessation outcomes in other population s. Ninety-five participants from an inner-city AIDS clinic were r and omized to receive either the CPI or recommended st and ard of care ( RSOC ) smoking cessation treatment . Participants r and omized to the RSOC group ( n=47 ) received brief advice to quit , a 10-week supply of nicotine patches , and self-help material s. Participants r and omized to the CPI group ( n=48 ) received RSOC components plus a series of eight proactive counseling sessions delivered via cell phones . A series of regression analyses ( linear and logistic ) was used to assess the relationships between treatment group , the hypothesized mediators , and biochemically confirmed smoking cessation outcomes . Results indicated that the CPI group experienced greater reductions in anxiety and depression , and increases in self-efficacy compared with the RSOC group . Further , changes in depression , anxiety , and self-efficacy weakened the association between treatment group and cessation outcome . The mediator hypothesis , however , for social support was rejected , as the difference score was not significantly associated with treatment group . These results suggest that the efficacy of the CPI is at least partially mediated by its ability to decrease symptoms of distress while increasing self-efficacy We wished to determine the short-term safety and efficacy of a Chinese medicinal herb preparation in treating symptoms of human immunodeficiency virus ( HIV ) infection in a 12-week r and omized , double-blind , placebo-controlled clinical trial in a University-affiliated acquired immunodeficiency syndrome ( AIDS ) clinic at a public general hospital . Thirty adults with symptomatic HIV infection , no previous AIDS-defining diagnosis , and CD4 + counts of 0.200 - 0.499 x 10(9)/L ( 200 - 499/mm3 ) received 28 tablets each day of either a st and ardized oral preparation of 31 Chinese herbs or a cellulose placebo . Primary outcome measures were changes in life satisfaction , perceived health , and number and severity of symptoms . Other outcomes included adherence , and changes in weight , CD4 + count , depression , anxiety , physical and social function , and mental health . Two placebo- and no herb-treated subjects had mild adverse events ( AE ) . Subjects on both arms reported taking 94 % of prescribed tablets . No differences between treatment groups reached the p < 0.05 level . Life satisfaction improved in herb-treated [ + 0.86 , 95 % confidence interval ( CI ) : + 0.29 , + 1.43 ] but not in placebo-treated subjects ( + 0.20 , 95 % CI -0.35 , + 0.75 ) . Number of symptoms was reduced in subjects receiving herbs ( -2.2 , 95 % CI -4.1 , -0.3 ) but not in those receiving placebo ( -0.3 , 95 % CI -3.2 , + 2.7 ) . There were trends toward greater improvements among herb-treated subjects on all symptom subscales except dermatologic . Believing that one was receiving herbs was strongly associated with reporting that the treatment had helped ( p < 0.005 ) , but not with changes in life satisfaction or symptoms . There were improvements in life satisfaction and symptoms among subjects receiving the herbal therapy . Whether Chinese herbs are effective in the management of symptomatic HIV infection can be adequately addressed only by larger trials of longer duration Background People who are HIV-positive now live longer when they have contracted AIDS , and nursing interventions can help improve their quality of life . Objectives To test the effects of an intervention based on developing cognitive coping skills as compared to one focused on facilitating the expression of emotions . Both interventions were intended to help regulate emotional response to an exacerbation of HIV-related symptoms . Method In a r and omized , controlled trial , 90 hospitalized HIV-positive men were r and omly assigned to one of three groups : cognitive , expression , or control . The intervention was administered on three consecutive days in 20–30 minute sessions . Preintervention and postintervention data were gathered on mood , distress , and anxiety . Results Both interventions produced a beneficial effect on negative affect ( cognitive group p = .002 , expression group p = .011 ) , and immediately following the first daily session ( p = .001 ) . No change in positive affect was produced by either intervention . Paired t tests indicated a decrease in distress ( p = .039 ) , specifically , of intrusive ideation ( p = .03 ) , for the cognitive group , which also experienced a decrease in anxiety from immediately before to immediately after each session . Conversely , the expression group experienced an increase in anxiety ( p = .018 ) . Discussion The cognitive coping skills nursing intervention was effective in helping to regulate HIV-positive persons ’ emotional responses to advanced disease . This nursing intervention is feasible for use by skilled practitioners providing daily care We examined the efficacy of a psycho-spiritual intervention of mantram repetition -- a word or phrase with spiritual associations repeated silently throughout the day -- on psychological distress ( intrusive thoughts , stress , anxiety , anger , depression ) , quality of life enjoyment and satisfaction , and existential spiritual well-being in HIV-infected adults . Using a 2-group by 4-time repeated measures design , 93 participants were r and omly assigned to mantram ( n = 46 ) or attention control group ( n = 47 ) . Over time , the mantram group improved significantly more than the control group in reducing trait-anger and increasing spiritual faith and spiritual connectedness . Actual mantram practice measured by wrist counters was inversely associated with non-HIV related intrusive thoughts and positively associated with quality of life , total existential spiritual well-being , meaning/peace , and spiritual faith . Intent-to-treat findings suggest that a mantram group intervention and actual mantram practice each make unique contributions for managing psychological distress and enhancing existential spiritual well-being in adults living with HIV/AIDS Objective : To determine the impact of nutritional ( selenium ) chemo-prevention on levels of psychological burden ( anxiety , depression , and mood state ) in HIV/AIDS . Method : A r and omized , double-blind , placebo-controlled selenium therapy ( 200 μ/day ) trial was conducted in HIV+ drug users from 1998–2000 . Psychosocial measures ( STAI-State and Trait anxiety , BDI-depression , and POMS- mood state ) , clinical status ( CD4 cell count , viral load ) , and plasma selenium levels were determined at baseline and compared with measurements obtained at the 12-month evaluation in 63 participants ( 32 men , 31 women ) . Results : The majority of the study participants reported elevated levels of both State ( 68 % ) and Trait ( 70 % ) anxiety . Approximately 25 % reported overall mood distress ( POMS > 60 ) and moderate depression ( BDI > 20 ) . Psychological burden was not influenced by current drug use , antiretroviral treatment , or viral load . At the 12-month evaluation , participants who received selenium reported increased vigor ( p = 0.004 ) and had less anxiety ( State , p = 0.05 and Trait , p = 0.02 ) , compared to the placebo-treated individuals . No apparent selenium-related affect on depression or distress was observed . The risk for state anxiety was almost four times higher , and nearly nine times greater for trait anxiety in the placebo-treated group , controlling for antiretroviral therapy , CD4 cell decline ( > 50 cells ) and years of education . Conclusions : Selenium therapy may be a beneficial treatment to decrease anxiety in HIV+ drug users who exhibit a high prevalence of psychological burden Psychological effects of participation in Protocol 019 , a zidovudine placebo-controlled clinical trial , were investigated . Forty-six Protocol 019 subjects and 27 control asymptomatic human immunodeficiency virus-seropositive subjects were assessed at entry , 2 months , 6 months , and after trial modification . At baseline there were no psychological differences . Most Protocol 019 and control subjects were depressed on at least one psychological measure ; fewer were anxious . Both groups had improvement over time . By 6 months , Protocol 019 subjects had decreased Beck Depression Inventory ( BDI ) scores , state anxiety , stress reaction , and symptoms of depression and anxiety . Controls had decreased scores on only the BDI . Over time , the percentage meeting modified DSM III-R criteria for anxiety decreased in both groups and the proportion of Protocol 019 subjects meeting DSM III-R depression criteria decreased . After protocol modification , study subjects were less depressed and distressed than controls . Protocol 019 subjects reduced depression symptoms but controls did not . Clinical trial participation was not deleterious and may have yielded some relative psychological benefit & NA ; We investigated the effects of two behavioral interventions —aerobic exercise and cognitive behavioral stress management (CBSM)—on Epstein‐Barr virus viral capsid antigen ( EBV‐VCA ) and human herpesvirus type‐6 ( HHV‐6 ) antibody modulation in 65 asymptomatic gay men measured at several time points in the 5 weeks preceding and following notification of their human immunodeficiency virus‐type 1 ( HIV‐1 ) serostatus . After accounting for potential immunomodulatory confounds , we found that HIV‐1 seropositive men had higher EBV‐VCA antibody titers than those diagnosed as seronegative at every time point during the study ; however , no significant differences were found with respect to HHV‐6 . Among HIV‐1 seropositive and seronegative subjects , respectively , those r and omized to either behavioral intervention had significant decreases in both EBV‐VCA and HHV‐6 antibody titers over the course of the intervention as compared with assessment ‐only controls ( of HIV‐1 seropositive and seronegative status ) whose antibody titers did not significantly change and which remained consistently higher than either serostatus‐matched intervention group over subsequent time points , independent of total immunoglobulin G levels and degree of polyclonal B cell activation . In attempting to explain serostatus differences in EBV and HHV‐6 values , it was found that HIV‐1 seropositive men had significantly lower CD4 cells , CD4:CD8 ratio , and blastogenic response to phytohemagglutinin ( PHA ) , as well as significantly higher CD8 cells at baseline . No significant differences were found between the HIV‐1 seropositive and seronegative men with respect to anxiety and depression at baseline . Since the greatest changes in EBV and HHV‐6 occurred between baseline and week 10 , we correlated changes in immune ( CD4 , CD8 , CD4:CD8 ratio , PHA stimulation ) and distress‐related markers ( state depression and anxiety ) with EBV and HHV‐6 change scores over this time period . No significant correlations were found between any of these immune‐ or distress‐related variable and the antibody change scores suggesting that the mechanisms by which EBV and HHV‐6 antibodies are being modulated by these interventions possibly involve other , yet to be determined , immune , neuroendocrine , and /or psychologic variables Objective : To evaluate the safety and efficacy of polyalkylimide gel ( PAIG ) in the treatment of HIV-associated facial lipoatrophy . Design : A r and omized , open-label , single-centre study . Methods : HIV-positive individuals with facial lipoatrophy ( based on physician assessment ) were r and omly assigned to immediate ( weeks 0 and 6 ) or delayed ( weeks 12 and 18 ) PAIG injections administered into the subcutaneous plane . Outcome measures included a change in facial lipoatrophy severity scores ( five-point scale ) , adverse events , photographic assessment , and changes in quality of life ( QoL ) , depression and anxiety using vali date d surveys . Results : Thirty-one patients ( median age 48 years , 97 % male ) were enrolled and completed 48 weeks of follow-up . Overall , the median volume of product injected bilaterally was 16.0 ml . Adverse events , including swelling , redness , bruising and pain , were mild , and resolved after a median of 3 days . There were no cases of necrosis , nodules or infection . Compared with patients r and omly assigned to delayed treatment , patients in the immediate therapy group had significantly lower physician-rated facial lipoatrophy scores ( 0 versus 2 ; P < 0.0001 ) , improved QoL ( P = 0.01 ) , and lower anxiety ( P = 0.02 ) at week 12 . At week 48 , median physician and patient facial lipoatrophy scores were 0 and 1 , respectively , for the entire cohort , and were not significantly different between the groups . Significant improvements in patient anxiety ( P = 0.001 ) and depression ( P = 0.01 ) were observed from baseline to week 48 . Conclusion : Treatment with PAIG was effective and safe and led to improvements in facial lipoatrophy grading , QoL , anxiety and depression scores in HIV-infected patients with facial lipoatrophy Abstract Symptom management for persons living with HIV/AIDS is an extremely important component of care management . The importance of pharmacologic interventions for management of symptoms is well recognized , and non-pharmacologic strategies such as art therapy are gaining interest in lay and professional communities . The aim of this research project was to test the feasibility and effectiveness of art therapy for relief of symptoms experienced by people living with HIV/AIDS . In this r and omized clinical trial of art therapy , the primary objective was to assess change in physical and psychological symptoms . Participants were recruited from a large urban hospital 's inpatient population and outpatient HIV clinic . Seventy-nine people with a diagnosis of HIV infection provided socio-demographic information , participated in either a one-hour art therapy session or viewed a videotape about art therapy , and completed pre- and posttest measures of psychological and physical symptoms . Two separate analysis of covariance models were used to identify if the treatment condition influenced psychological and physical symptoms , after adjusting for pretest score , age , gender , and race/ethnicity . The analyses showed that physical symptom mean scores were better for those who participated in the art therapy compared to those who viewed the videotape , and this difference between conditions was statistically significant ( p<0.05 ) . Thus , the study demonstrated the potential benefits of one session of art therapy in relation to symptoms associated with HIV/AIDS CONTEXT Alternative medicine or complementary remedies that have not been scientifically tested are nonetheless widely used to treat chronic illnesses , particularly if curative options are limited . OBJECTIVES To assess the effectiveness of Chinese medicinal herbs in reducing symptoms and improving the quality of life of HIV-infected persons . DESIGN Prospect i ve , placebo-controlled double-blind study . SETTING University-based HIV outpatient clinic . PATIENTS 68 HIV-infected adults with CD4 cell counts < 0.5 x 10(9)/L. INTERVENTION Participants were r and omized to receive four daily doses of seven pills containing a st and ardized preparation of 35 Chinese herbs or placebo for 6 months . MAIN OUTCOME MEASURES Symptoms , HIV disease progression , HIV-1 RNA plasma viral loads , CD4 and CD8 cell counts , and scores on st and ard question naires for quality of life , depression , anxiety , and coping . RESULTS Intervention and placebo groups were equivalent at baseline regarding , respectively , previous antiretroviral therapy ( 74 % versus 79 % ) , median CD4 cell counts ( 0.20 x 10(9)/L versus 0.25 x 10(9)/L ) , and median HIV-1 plasma viral loads ( 35,612 copies/ml versus 52,027 copies/ml ) . At enrollment , none of the study subjects was seriously ill or depressed , and average coping and quality of life scores were in the normal range . In all , 53 ( 78 % ) participants completed the study . Patients taking Chinese herbs reported significantly more gastrointestinal disturbances ( 79 % versus 38 % ; p = .003 ) than those receiving placebo . No therapy-related toxicities were observed . At completion of the study , no significant differences between the intervention and placebo groups were found regarding plasma viral loads , CD4 cell counts , symptoms , and psychometric parameters . HIV-1 RNA level was unchanged at study end . Among participants who were not on concomitant antiretroviral therapy , median CD4 cell counts declined by 0.05 x 10(9)/L in both the intervention and placebo groups . CONCLUSIONS This st and ardized formulation of Chinese herbs for HIV-infected individuals did not improve quality of life , clinical manifestations , plasma virus loads , or CD4 cell counts . The data suggest that this formulation of Chinese herbs is not effective when administered in a Western medicine setting In this pilot study , 20 HIV-infected children , 6 to 12 years of age , were r and omly assigned into therapeutic touch ( TT ) and mimic TT groups . The effectiveness of TT in reducing anxiety was evaluated . The self-report measure , the A-State Anxiety subscale of the Spielberger State-Trait Anxiety Inventory For Children , was administered before and immediately after interventions . As predicted , the TT intervention result ed in lower overall mean anxiety scores , whereas the mimic TT did not . These findings provide preliminary support for the use of TT in reducing the state anxiety of children with HIV infection Background : Mood disorders and other neuropsychiatric disorders are common adverse events limiting tolerability of α-interferon ( IFN ) therapy for hepatitis C virus ( HCV ) . Because efavirenz ( EFV ) frequently produces neuropsychiatric side effects , we studied the effect of EFV in the incidence of these side effects in HIV/HCV patients receiving IFN . Methods : Prospect i ve cohort of HIV/HCV patients receiving IFN and ribavirin . Adverse events and concomitant medications were systematic ally recorded once monthly . Results : Among 266 HIV/HCV patients starting a course of IFN ( 91 % pegylated IFN ) plus ribavirin , 53 ( 20 % ) received concomitant EFV and 213 ( 80 % ) did not . Most EFV patients ( 92 % ) were already on EFV before starting IFN ( mean 26 months ) . Neuropsychiatric side effects were frequent , without significant differences between both groups ( 79 % vs 65 % , P = 0.051 ) , and only 10 patients discontinued IFN . Mood disorders were reported more frequently in EFV patients ( 36 % vs 23 % , P = 0.046 ) , but antidepressant therapy use was similar in both groups . The incidence of anxiety , insomnia , irritability , headache or prescription of anxiolytics or hypnotics was similar . Conclusions : Neuropsychiatric adverse events are common in HIV/HCV patients receiving IFN , usually mild or moderate . EFV may favor symptoms of mood disorders , although it was not related to an increased risk of significant depression requiring specific treatment Somatic symptoms often complicate the diagnosis and psychopharmacological treatment of depression in HIV illness . We treated 33 depressed HIV-positive men and women with medically symptomatic HIV or AIDS ( CDC stages 2B , 2C , 3B , or 3C ) in a 6 week open-label trial with sertraline , paroxetine , or fluoxetine , to assess their effectiveness and tolerability . We further assessed whether treatment of depression result ed in a reduction in both affective and somatic symptoms in this medically ill population . Twenty-four subjects ( 73 % ) completed the trial ( 7 on sertraline , 7 on paroxetine , 10 on fluoxetine ) , 20 ( 83 % ) of whom were clinical responders . Nine dropped out within 1 - 3 weeks of treatment because of adverse effects , mostly agitation , anxiety , and insomnia . Subjects who completed 6 weeks of SSRI treatment experienced significant reductions in both affective and somatic symptoms , many of the latter having been attributed to HIV rather than depression . These results suggest that , even in later stages of HIV illness , the contribution of depression to perceived somatic symptoms may be significant , and that these symptoms may improve with antidepressant treatment BACKGROUND Polylactic acid ( PLA , New-Fill ; Medifill , London , UK and Dermic Labs , a division of Eventis , Strasbourg , France ) injections into the deep dermis increase fibroblast numbers and collagen production . The substance is widely used in medical applications including cosmetic procedures . METHODS HIV-positive individuals with facial lipoatrophy ( based on physician assessment ) were r and omized to immediate ( weeks 0 , 2 and 4 ) or delayed ( weeks 12 , 14 and 16 ) PLA given as three bilateral injections 2 weeks apart into the deep dermis overlying the buccal fat pad . Assessment s included facial ultrasound , visual analogue scales , the Hospital Anxiety and Depression Scale ( HADS ) and assessment using photographs at weeks 0 , 12 and 24 . RESULTS All 30 patients completed 24 weeks of treatment . The median age of the patients was 41 years , with a mean of 80 months of nucleoside reverse transcriptase inhibitor ( NRTI ) therapy and a mean of 44 months of prior protease inhibitor ( PI ) therapy . The median CD4 count was 428 - 460 cells/microL , with 47 % of patients in the immediate-treatment group and 93 % of patients in the delayed-treatment groups with < 50 HIV-1 RNA copies/mL at baseline . No differences in immunological , virological , biochemical , haematological or metabolic parameters emerged during the study . Injections were well tolerated with only two adverse events ( cellulitis and bruising ) recorded , one of which delayed treatment by 1 week . There were no discontinuations . Patient visual analogue assessment s , photographic assessment s , and anxiety and depression scores improved with treatment . At week 12 , immediate-treatment patients had significantly better visual analogue scores ( 7 vs. 1 , P<0.001 ) and lower anxiety scores ( 6 vs. 9 , P=0.056 ) than delayed-treatment patients . Benefits on visual analogue and HADS scores persisted until week 24 . CONCLUSIONS PLA injections led to improvements in patient self-perception , anxiety and depression scores in individuals with facial lipoatrophy . Adverse events were uncommon . The benefits of PLA persisted for at least 18 weeks beyond the last injection & NA ; Pain is a common and pervasive symptom for persons infected with the human immunodeficiency virus ( HIV ) . Individuals with persistent pain are known to be at heightened risk for posttraumatic stress disorder ( PTSD ) , an anxiety disorder that manifests itself following exposure to a traumatic event . Moreover , research suggests that patients with persistent pain who develop PTSD often experience greater pain intensity and pain‐related disability than those who do not develop PTSD . The purpose of this study was to assess the relation of PTSD to pain intensity and pain‐related interference in HIV‐infected persons suffering from persistent pain . Study participants included 145 ambulatory persons living with HIV/AIDS ( PWHAs ) who were enrolled in a r and omized clinical trial assessing the impact of a pain communication intervention . Participants completed a series of self‐report measures including the Stressful Life Events Checklist ( SLE ) , the Posttraumatic Stress Disorder Checklist‐Civilian ( PCL‐C ) , the Mental Health Inventory ( MHI ) , and the Brief Pain Inventory ( BPI ) . On average , participants reported being exposed to 6.3 different types of trauma over the course of their lifetime , of which receiving an HIV diagnosis was rated as being among the most stressful . Over half ( 53.8 % ) merited a PTSD diagnosis according to the PCL‐C. Those with PTSD reported having significantly higher pain intensity and greater pain‐related interference in performance of daily activities ( i.e. , working , sleeping , walking ability and general activity ) , and affect ( i.e. , mood , relations with other people , enjoyment of life ) over time than those who did not meet the diagnostic criteria . Possible explanations for these findings are discussed along with implication s for clinical care This study tested the effects of a 7-week individual self-management and coping skills training program on various measures of health and well-being of persons with HIV/AIDS . Forty men and women were r and omly assigned the treatment or wait-list control group . Treated participants showed significant posttreatment changes on all four major measures of mood , coping , and health attitudes . Treatment significantly improved coping strategies as measured by the use and effective measures of the Jalowiec Coping Scale and several of its subscales , including decreases in use of emotive , fatalistic , and palliative coping styles . Psychological mood was improved , as measured by the Profile of Moods Total Mood Disturbance ( POMS TMD ) score and specific subscales of the POMS , which were targeted in the intervention ( e.g. , Anger ) . Treated participants also showed significant increases on the Internal subscale of the Health Attribution Test This study examined salivary cortisol and mood during relaxation training in 30 symptomatic , HIV+ gay men participating in a 10-week , group-based cognitive-behavioral stress management intervention . Cortisol levels and mood were assessed within these sessions just before and after 45-min relaxation exercises given as part of each session . Participants also recorded their stress level and compliance with daily home relaxation practice . Presession cortisol levels decreased across the 10-week period and were related to decreases in global measures of total mood disturbance and anxious mood . Reductions in presession cortisol levels were also associated with decreases in self-reported stress level during home practice . Greater reductions in cortisol during the first three sessions were associated with more frequent relaxation practice at home . These findings suggest that salivary cortisol represents an objective neuroendocrine marker for changes in anxiety and distress observed during relaxation training in symptomatic , HIV-seropositive men BACKGROUND Bereavement is a severe and frequent stressor among those infected with human immunodeficiency virus type 1 ( HIV-1 ) and those affected by the acquired immunodeficiency syndrome epidemic . This study examined the impact of a research -derived , semistructured , bereavement support group among HIV-1-seropositive and HIV-1-seronegative homosexual men having lost a close friend or intimate partner to the acquired immunodeficiency syndrome within the prior 6 months . METHODS A total of 166 subjects ( 97 HIV-1 seropositive ; 69 HIV- 1 seronegative ) were r and omly assigned to groups of homogeneous HIV-1 serostatus or to their respective control group . Subjects were assessed at entry and at 10 weeks with psychosocial question naires , a semistructured interview for psychopathology , a medical history and physical examination , urine collection , and phlebotomy . RESULTS For a composite score of psychological distress and grief as well as the distress component , scores were significantly lower after the intervention by analyses against baseline scores , with and without control variables for other factors affecting distress level . A significant reduction in grief level was found only in the analysis that included control variables . Control subjects showed no significant decrements in overall distress , although a significant decrement in grief level was observed . CONCLUSION A brief group intervention can significantly reduce overall distress and accelerate grief reduction in a sample of bereaved subjects unselected for psychopathology or at high risk for subsequent maladjustment Background Human immunodeficiency virus ( HIV ) infection has become a serious health problem for low-income African American women in their childbearing years . Interventions that help them cope with feelings about having HIV and increase their underst and ing of HIV as a chronic disease in which self-care practice s , regular health visits , and medications can improve the quality of life can lead to better health outcomes . Objective This study aim ed to determine the efficacy of an HIV self-care symptom management intervention for emotional distress and perceptions of health among low-income African American mothers with HIV . Method Women caregivers of young children were r and omly assigned to self-care symptom management intervention or usual care . The intervention , based on a conceptual model related to HIV in African American women , involved six home visits by registered nurses . A baseline pretest and two posttests were conducted with the mothers in both groups . Emotional distress was assessed as depressive symptoms , affective state , stigma , and worry about HIV . Health , self-reported by the mothers , included the number of infections and aspects of health-related quality of life ( i.e. , perception of health , physical function , energy , health distress , and role function ) . Results Regarding emotional distress , the mothers in the experimental group reported fewer feelings of stigma than the mothers in the control group . Outcome assessment s of health indicated that the mothers in the experimental group reported higher physical function scores than the control mothers . Within group analysis over time showed a reduction in negative affective state ( depression/dejection and tension/anxiety ) and stigma as well as infections in the intervention group mothers , whereas a decline in physical and role function was found in the control group . Conclusions The HIV symptom management intervention has potential as a case management or clinical intervention model for use by public health nurses visiting the home or by advanced practice nurses who see HIV-infected women in primary care or specialty clinics This study tested the effects of a 10-week group cognitive-behavioral stress management ( CBSM ) intervention on mood and immunologic parameters in HIV-seropositive gay men whose disease had progressed to a symptomatic stage . Men were r and omized to either CBSM or a modified waiting-list control group . The CBSM intervention significantly decreased self-reported dysphoria , anxiety , and total distress . Individuals who practice d relaxation more consistently had significantly greater drops in dysphoria . The intervention also decreased herpes simplex virus-Type 2 ( HSV-2 ) immunoglobulin G antibody titers . The control group showed no significant changes in either mood or antibody titers . Individual difference analyses revealed that decreases in dysphoria significantly predicted lower HSV-2 antibody titers by the end of the 10-week period . Neither group displayed changes in HSV-Type 1 antibody titers or in CD4 + or CD8 + cell numbers & NA ; The knowledge of being infected with the human immunodeficiency virus type 1 ( HIV‐1 ) brings about psychological distress and social problems including anxiety , depression , and social isolation . Participating in psychosocial intervention programs can help to reduce these problems . To date , however , very little is known about the efficacy of different intervention strategies . We implemented a study with a r and omized experimental design to investigate the effectiveness of a cognitive‐behavioral group psychotherapy ( CBT ) and an experiential group psychotherapy ( ET ) program for 39 asymptomatic HIV‐infected homosexual men . Both therapies consisted of 17 sessions over a 15‐week period . The major finding of this study was that psychosocial intervention , independent of the therapeutic orientation , decreased distress significantly , as compared with a waiting‐list control group ( WCG ) . There were no significant changes in the intervention groups as compared with the WCG in coping styles , social support , and emotional expression . Finally , CBT and ET did not differ in their effects on psychological distress or on the other psychosocial variables measured in this study OBJECTIVE Although many studies have documented patterns of emotional distress in persons with HIV disease , there have been few controlled evaluations of therapy outcomes with these individuals . This research evaluated the effects of brief cognitive-behavioral or social support group therapy with this population . METHOD Sixty-eight depressed men with HIV infection were r and omly assigned to one of three conditions : eight-session cognitive-behavioral groups , eight-session social support groups , or a comparison condition . Before and after intervention and at 3-month follow-up , all participants were individually assessed by using measures of symptoms of distress as well as substance use and sexual practice s. RESULTS Relative to the comparison group , both the cognitive-behavioral and social support group therapies produced reductions in depression , hostility , and somatization . The social support intervention also produced reductions in overall psychiatric symptoms and tended to reduce maladaptive interpersonal sensitivity , anxiety , and frequency of unprotected receptive anal intercourse , while the cognitive-behavioral intervention result ed in less frequent illicit drug use during the follow-up period . Tests for clinical significance of change particularly underscored benefits of the social support group intervention both at postintervention and at long-term follow-up . CONCLUSIONS Brief group therapy for depressed persons with HIV infection produced reductions in symptoms of distress . The two forms of therapy result ed in shared and unique improvements in functioning , although social support groups focused on emotional coping presented greater evidence of clinical ly significant change . As more persons contract HIV infection and live longer with HIV disease , further research is needed to evaluate outcomes of mental health services with these individuals Context Neurologic toxicity is the most commonly reported adverse effect of the antiretroviral drug efavirenz . Contribution In this sub study of a r and omized , controlled trial , 12 of 200 ( 6 % ) HIV-infected individuals discontinued treatment with efavirenz because of central nervous system symptoms or mood disorders versus 0 of 103 individuals ( 0 % ) who were not receiving the drug . Although patients taking efavirenz had more neuropsychological symptoms , such as bad dreams , in the first week of therapy , no statistically significant neuropsychological differences were found at weeks 4 , 12 , and 24 . Implication s Some adverse neuropsychological effects associated with efavirenz are probably transient . The Editors Efavirenz is a non-nucleoside reverse transcriptase inhibitor approved for treatment of HIV infection . The drug is potent , is generally well tolerated , and can be administered once daily , making it a preferred treatment option for HIV infection ( 1 , 2 ) . The most commonly reported adverse effect with efavirenz is neurologic toxicity , with more than 50 % of patients reporting symptoms in open-label studies ( 1 , 3 ) . Our r and omized , controlled study prospect ively characterized aspects of the neurologic toxicity of 3 protease inhibitorsparing antiretroviral regimens for the initial treatment of HIV infection . Methods This investigator-initiated trial was a sub study of the AIDS Clinical Trials Group study A5095 , a r and omized , double-blind trial of 3 antiretroviral regimens : zidovudine and lamivudine in combination with efavirenz ; abacavir ; or abacavir and efavirenz in combination ( 4 ) . For simplicity , we will refer to 2 groups : patients who received efavirenz ( with or without abacavir ) and those who did not . R and omization was performed central ly without reference to center . The study was supported by the National Institutes of Health ( NIH ) and was approved by the institutional review boards at each of the participating institutions , with each patient providing informed consent to participate in the sub study . All patients at sites taking part in the sub study were invited to participate before r and omization for the parent study ( Figure 1 ) . Unblinding and within-class substitutions were allowed in cases of treatment-limiting toxicity ( we substituted stavudine for zidovudine , didanosine for abacavir , and nevirapine for efavirenz ) . Participants had not previously received antiretroviral therapy , and their baseline plasma HIV-1 RNA levels were greater than 400 copies/mL. Parent study A5095 enrolled 1147 participants , of whom 303 at 36 clinical trials units volunteered to participate in the additional evaluations for A5097s . Participants were recruited between March 2001 and January 2002 . Figure 1 . CONSORT diagram of sub study 5097s . The primary measures of neuropsychological performance were the Trail Making Tests ( Parts A and B ) and the Digit Symbol Substitution Test ( part of the Wechsler Adult Intelligence Scale III [ 5 ] ) . A summary neuropsychological Z score ( NPZ3 ) was derived from the sum of the scores from these 3 tests and st and ardized for age . Positive scores indicated above-normal function , whereas negative scores indicated below-normal function . The entire score was coded as missing if any component of the NPZ3 was not available . The Neurologic AIDS Research Consortium provided administrator training at each site . These tests assessed functioning in the areas of motor persistence , sustained attention , response speed , visuomotor coordination , and conceptual shifting and tracking . Neuropsychometric measures were collected at baseline and at weeks 1 , 4 , 12 , and 24 . Testing was performed at each time point to assess symptoms that might be associated with efavirenz use , sleep disorders , anxiety , depression , and history of drug abuse . The instruments are summarized in Table 1 . The symptom question naire developed for this study is shown in the Appendix Figure . Appendix Figure . Sample participant question naire . Table 1 . Testing Instruments Whole blood was collected from all participants to determine efavirenz trough concentrations in plasma ( 13 ) . These data were used to explore relationships between drug exposure and other variables that were evaluated in the study . Statistical Analysis Our sub study was design ed to compare neurologic changes from baseline in patients who received efavirenz with changes in those who did not . The study had 90 % power to detect a st and ard deviation of 0.4 for change in the summary neuropsychological performance score from baseline to week 1 . We presented descriptive statistics for the study sample and used nonparametric tests to determine treatment differences . Using the nonparametric methods of Hodges and Lehmann ( 14 ) and Proc-StatXact software , version 4.0.1 ( Cytel Software Corp. , Cambridge , Massachusetts ) , we estimated treatment differences for continuous outcomes with corresponding exact confidence intervals . Generalized estimating equation modeling ( a regression method ) and the Wei-Johnson test ( a nonparametric method for analyzing incomplete 2- sample data ) ( 15 ) were used to compare treatment groups longitudinally ; both methods assumed that data were missing completely at r and om . We used the Spearman correlation coefficient , a rank-based method that is robust to extreme observations , to evaluate correlations . All significance testing was performed at an level of 0.05 with no adjustment for multiple testing . All reported P values were 2-sided . To assess the potential effect of any missing data , we performed multiple imputation , analyzed 2 worst-case scenarios ( Appendix Table 1 and Appendix Table 2 ) , and conducted an as-treated analysis that excluded patients who discontinued efavirenz therapy . We used SAS software ( SAS Institute , Inc. , Cary , North Carolina ) to perform statistical analyses . Test sources included Elsevier Science ( Oxford , United Kingdom ) for the Pittsburgh Sleep Quality Index , Mind Garden ( Redwood City , California ) for the State-Trait Anxiety Inventory for Adults , and the National Institute of Mental Health ( Bethesda , Maryl and ) for the Center for Epidemiologic Studies Depression Scale . Role of the Funding Sources This investigator-initiated protocol was supported by the NIH . Drugs used in the study were donated by pharmaceutical companies whose representatives participated in team discussion s. The study was monitored by NIH-contracted monitors and was supervised by a data safety monitoring committee that was appointed by the National Institute of Allergy and Infectious Diseases . The NIH-supported biostatistical team working with the AIDS Clinical Trials Group and the Neurologic AIDS Research Consortium performed the statistical analyses . The protocol team , led by the first author , had final responsibility for the study protocol , case report forms , statistical analysis plan , progress of the study , analysis , and reporting of the data , regardless of outcome . The final version was the sole responsibility of the authors . The team had full access to the data files of the study . Results Baseline Evaluations Recruitment characteristics are displayed in Figure 1 ; demographic characteristics of the study participants are presented in Table 2 . The treatment groups were balanced at baseline with respect to demographic characteristics , neuropsychological measures , and responses to the symptom question naire . The sleep disturbance component of the global sleep index demonstrated a baseline difference ; the patients who eventually received efavirenz had marginally more sleep disturbances ( P= 0.048 ) ( data not shown ) . Other components of the sleep index , including quality , latency , duration , efficiency , use of sleeping medication , and daytime dysfunction , were similar between groups . Alcohol abuse , drug use , and affective disturbances were infrequent and similar for both groups . Table 2 . Baseline Characteristics and Evaluations by Treatment Group Disposition of Study Participants The study allowed for drug substitution from the same class of antiretroviral agents in cases of treatment-limiting toxicity . Table 3 summarizes the modifications that occurred and the respective reasons . Appendix Table 3 gives further details of timing of modifications and the ethnicity of the individuals . Primary end point data ( the change in NPZ3 from baseline to week 1 ) were observed in 283 of the 303 ( 93.4 % ) participants . Table 3 . Reasons for Modification of Treatment Appendix Table 1 . Neuropsychological Performance Appendix Table 2 . Results of Sensitivity Analysis by Generalized Estimating Equation Method Appendix Table 3 . Status and Ethnicity of Patients Requiring Modification of Treatment Prospect i ve Evaluations Median NPZ3 scores improved in both groups during the study , with the greatest change occurring in the first week of treatment ( Figure 2 ) . No statistically significant differences in changes in neuropsychological performance were observed between the groups at any time point . We conducted conventional longitudinal analyses to further investigate differences in neuropsychological scores between the treatment groups . On the basis of these analyses , we had insufficient evidence to conclude that there were treatment differences ( generalized estimating equation modeling in which treatment was the only independent variable and an exchangeable correlation structure was assumed , P= 0.176 ; Wei-Johnson test , P= 0.196 ) . Multiple sensitivity analyses were performed , including single and multiple imputation methods , as-treated analyses , and 2 forms of worst-case scenarios . Details of these analyses are shown in Appendix Table 1 . Multiple imputation and as-treated analyses generally provided similar results to observed data at specific weeks ; however , the worst-case analyses at weeks 4 , 12 , and 24 displayed significant differences between groups . These results suggest that differences between groups might exist if the worst-case scenario were true , that is , if patients without data who were receiving efavirenz had Forty-six Chinese patients with symptomatic human immunodeficiency virus ( HIV ) participated in a comparative study assessing the effectiveness of cognitive-behavioral group therapy ( CBT ) and peer support/counseling group therapy ( PSC ) in relation to improving mood and quality of life and decreasing uncertainty in illness as compared to a group receiving routine treatment with no formal psychosocial intervention . The CBT group consisted of 10 subjects , the PSC group of 10 subjects , and the comparison group of 26 subjects . There was a 24 % attrition rate . The intervention groups received 12 weekly sessions of therapy over 3 months . Assessment of mood states was carried out before r and omization ( baseline data ) , immediately postintervention ( 3-month time point ) and followed-up 3 months later ( 6-month time point ) . Assessment of quality of life and uncertainty in illness was carried out before r and omization and at the 6-month follow-up time point . Results indicated that the mood of the participants in the CBT group improved in terms of anger , tension-anxiety , depression , confusion , and overall mood . The quality of life in this group was significantly improved compared to the other two groups , as was uncertainty in illness . In the PSC group a worsening of psychologic functioning was observed immediately postintervention , but this picture dramatically improved at the follow-up assessment with improvements of up to 34 % . Quality of life also improved over time in this group by almost 5 % , but results did not reach statistical significance . This study demonstrated that psychologic interventions could decrease psychologic distress and improve quality of life in symptomatic HIV patients , indicating their use should be incorporated in the management of care of people living with HIV/AIDS OBJECTIVE This study aim ed to assess the usefulness of two interventions in a group rehabilitation medicine setting to determine strategies and exercise guidelines for long-term care of the HIV/AIDS population with human immunodeficiency virus ( HIV ) and /or acquired immunodeficiency syndrome ( AIDS ) . DESIGN This was a r and omized clinical trial investigating the effects of tai chi ( TC ) and aerobic exercise ( EX ) on functional outcomes and quality of life ( QOL ) in patients with AIDS . SETTING Two outpatient infectious disease clinics in a mid-atlantic state were the setting . SUBJECTS AND INTERVENTION Thirty-eight ( 38 ) subjects with advanced HIV ( AIDS ) were r and omized to one of three groups : TC , EX , or control . Experimental groups exercised twice weekly for 8 weeks . OUTCOME MEASURES The primary outcomes included QOL as measured by the Medical Outcomes Short Form ( MOS-HIV ) and Spirituality Well-Being Scale ( SWB ) . Functional measures included the functional reach ( FR ) for balance , sit and reach ( SR ) for flexibility , and sit-up ( SU ) test for endurance . The physical performance test ( PPT ) was used to determine overall function , and the Profile of Mood States ( POMS ) was used to evaluate psychologic changes . To consider the patients ' explanations for these measurements , qualitative data were collected from subjects ' journals , focus groups , and nonparticipant observation . RESULTS Thirty-eight ( 38 ) subjects were included in data analysis : 13 in the TC group , 13 in the EX group , and 12 in the control group . Results of analysis of covariance showed significant changes in the exercise groups in overall functional measures ( p < 0.001 ) . The MOS-HIV showed a significant difference on the subscale of overall health ( p = 0.04 ) . The POMS showed significant main effect for time in confusion-bewilderment ( p = 0.000 ) and tension-anxiety ( p = 0.005 ) . Three dominant themes emerged from the qualitative data , including : positive physical changes , enhanced psychologic coping , and improved social interactions . CONCLUSIONS This study shows that TC and EX improve physiologic parameters , functional outcomes , and QOL . Group intervention provides a socialization context for management of chronic HIV disease . This study supports the need for more research investigating the effect of other types of group exercise for this population . This study sets the stage for a larger r and omized controlled trial to examine the potential short- and long-term effects of group exercise that may prove beneficial in the management of advanced HIV disease . Further research is warranted to evaluate additional exercise interventions that are accessible , safe , and cost-effective for the HIV population A small pilot trial of a multicomponent ( behavioral strategies , simplified patient information , and social support ) and multidisciplinary ( cognitive-behavioral therapy and nursing ) medication adherence intervention was conducted for HIV-infected adults prescribed antiretrovirals . Patients ( N = 33 ) were r and omly assigned to the intervention condition or st and ard care . Compared to the control group , patients in the intervention condition had significantly higher self-efficacy to communicate with clinic staff ( p = .04 ) and to continue treatment ( p = .04 ) , were significantly more likely to be using behavioral and cognitive strategies ( p = .01 and p = .04 ) , reported significantly higher life satisfaction ( p = .03 ) , reported significantly increased feelings of social support ( p = .04 ) , and showed a trend toward an increase in taking their medications on schedule ( p = .06 ) . The intervention , however , did not appear to affect health-related anxiety or to significantly improve adherence to dose . Implication s for future intervention planning are discussed Abstract In this study , 40 HIV-seropositive , cocaine abusing , methadone maintained drug users were r and omized to either the st and ard five-needle National Acupuncture Detoxification Association ( NADA ) protocol or to a reduced , escalating dose ( one to three needle ) protocol . In addition to receiving their assigned acupuncture treatments , the last 15 patients also received a spirituality-focused group therapy intervention . Acupuncture treatments were offered five days per week for eight weeks . Urine sample s were collected twice weekly and were analyzed for the presence of cocaine and heroin . Depression and anxiety were assessed pre- and post-treatment . Results showed no difference between the two acupuncture conditions on the number of weeks in which urine sample s tested negative for illicit opiate and cocaine use . However , patients who received the spirituality-focused group therapy in addition to their assigned acupuncture treatment were abstinent from heroin and cocaine for significantly longer , and had greater reductions in depression and anxiety than did those patients not receiving spirituality-focused psychotherapy . These preliminary findings suggest that acupuncture and a spirituality-focused psychotherapy may be a synergistic combination worthwhile investigating in larger scale , controlled studies The efficacy of trazodone and clorazepate to relieve anxiety and depressive symptoms in 21 HIV-positive subjects with adjustment disorders was determined in a 28-day single- centre , r and omized , double-blind study . Subjects were evaluated using the Hospital Anxiety and Depression Scale , the Revised Symptom Checklist , the European Organization for Research and the Treatment of Cancer Quality of Life Question naire , and a binary criterion based on the Clinical Global Impression . The incidence of successful treatment was 80 % for trazodone compared with 64 % for clorazepate ; the sample number was too small to establish a significant difference . Bayesian analysis revealed the probability of making a wrong decision in prescribing trazodone rather than clorazepate reduced from 35 % to 18 % in this small sample . Clinical evaluations using the different scales suggest some benefit from trazodone , although this was not significant . Safety of both treatments was similar . Trazodone is devoid of the risk of abuse and dependence , and may be a valuable alternative to benzodiazepines for the treatment of HIV-related adjustment disorders OBJECTIVE This study examined whether a selective serotonin reuptake inhibitor ( paroxetine ) had comparable efficacy but greater tolerability than a tricyclic antidepressant ( imipramine ) in depressed patients with HIV infection . METHOD Seventy-five HIV-positive patients ( 45 % of whom had AIDS ) were blindly and r and omly assigned to receive paroxetine ( N = 25 ) , imipramine ( N = 25 ) , or placebo ( N = 25 ) in a 12-week trial . The Hamilton Anxiety Rating Scale , the Hamilton Depression Rating Scale , the Clinical Global Impression scale , and the SAFETEE general inquiry ( for safety and tolerability ) were administered at weeks 2 , 4 , 6 , 8 , and 12 . RESULTS Fifty-six ( 75 % ) of the 75 patients completed 6 weeks and 34 ( 45 % ) completed 12 weeks of the trial . The mean daily doses of both paroxetine ( 33.9 mg ) and imipramine ( 162.5 mg ) were significantly more effective than placebo ; they were comparably effective at weeks 6 , 8 , and 12 according to the intent-to-treat analysis and at week 8 according to the analysis for the subjects who completed the trial ( for them , only imipramine was superior to placebo at week 12 ) . There were significantly more dropouts due to side effects from imipramine ( 48 % ) than from both paroxetine ( 20 % ) and placebo ( 24 % ) . CONCLUSIONS Depressed patients with HIV infection responded to imipramine or paroxetine at a higher rate than to placebo irrespective of severity of immunosuppression . Because paroxetine was much better tolerated than imipramine , its overall effectiveness may be greater . However , because of the small study group and the high attrition rate , these findings can not be generalized and may need replication in a larger study group OBJECTIVE The aim of the study was to investigate the impact of treatment-related clearance of hepatitis C virus ( HCV ) on cognitive function . METHODS A prospect i ve study was conducted in 19 HCV-monoinfected and 15 HIV/HCV-coinfected individuals undergoing pegylated interferon alpha-2a and ribavirin therapy between April 2003 and August 2005 . Neuropsychological , mood , and health-related quality of life ( HRQOL ) effects were assessed using computer-based battery , Trail Making Tests , Depression Anxiety Stress Scales and the Short Form-36 health survey . RESULTS Pretreatment cognitive function , mood status , and HRQOL were similar between the HCV patient groups . Sustained virological response ( SVR ) rates were similar between HCV-monoinfected ( 68 % ) and HIV/HCV-coinfected ( 73 % ) groups . SVR was associated with significant improvements in some measures of cognitive function , independent of HRQOL improvement . CONCLUSIONS Our findings provide evidence to support cognitive effects of HCV independent of mood status and HRQOL profiles Objective We have previously reported decreases in dysphoria , anxiety , and total mood disturbance in symptomatic HIV seropositive gay men after a 10-week cognitive behavioral stress management ( CBSM ) group intervention . This structured intervention was design ed a ) to increase cognitive and behavioral coping skills related to managing the distress of symptomatic HIV , and b ) to increase social support among group members . Here we examine the relative contribution of changes in coping skills and social support during the intervention period to reductions in dysphoria , anxiety , and distress-related symptoms in this sample . Methods Participants were r and omized to a 10-week CBSM group intervention or to a wait-list control condition . Coping , social supports , and mood were measured before and after the intervention period . Results Members of the CBSM group ( N = 22 ) showed significant improvement in cognitive coping strategies involving positive reframing and acceptance , and in social supports involving attachment , alliances , and guidance at the end of the 10-week CBSM program compared with controls ( N = 18 ) who showed decrements in these coping abilities and no changes in social support . Improved cognitive coping , specifically acceptance of the HIV infection , was strongly related to lower dysphoria , anxiety , and total mood disturbance in both conditions . Changes in social support and in cognitive coping skills seem to mediate the effects of the experimental condition on the changes in distress noted during the intervention . Conclusions These results suggest that cognitive coping and social support factors can be modified by psychosocial interventions and may be important determinants of the changes in psychological well-being and quality of life during symptomatic HIV infection that can be achieved through this form of intervention Objective Coinfection with herpes simplex virus type 2 ( HSV-2 ) is common in individuals infected with human immunodeficiency virus ( HIV ) and may have health implication s. This study examined the effect of a 10-week cognitive behavioral stress management ( CBSM ) intervention on immunoglobulin G ( IgG ) antibody titers to HSV-2 in a group of mildly symptomatic HIV-infected gay men and the degree to which these effects were mediated by psychosocial and endocrine changes during the 10-week period . Methods Sixty-two HIV+ gay men were r and omly assigned to either a 10-week CBSM intervention ( N = 41 ) or a wait-list control condition ( N = 21 ) . Anxious mood , social support , cortisol/dehydroepi and rosterone sulfate ( DHEA-S ) ratio levels , and HSV-2 IgG antibody titers were assessed at baseline and after the 10-week period . CBSM participants also recorded their stress levels before and after at-home relaxation practice . Results HSV-2 IgG titers were significantly reduced in the CBSM participants but remained unchanged in the control group after the 10-week intervention period . Increases in one type of social support , perceived receipt of guidance , during the 10 weeks was associated with and partially mediated the effect of the intervention on HSV-2 IgG. Similarly , decreases in cortisol/DHEA-S ratio levels were associated with decreases in HSV-2 IgG , and lower mean stress levels achieved after home relaxation practice were associated with greater decreases in HSV-2 IgG among CBSM participants . Conclusions These findings suggest that behavioral and psychosocial changes occurring during CBSM interventions , including relaxation , enhanced social support , and adrenal hormone reductions , may help to explain the effects of this form of stress management on immune indices such as HSV-2 antibody titers We examined the efficacy of relaxation techniques in a sample of HIV patients without AIDS in the early stages after infection , by comparing the three groups : relaxation group ( progressive muscle relaxation and modified autogenic training ) ; ordinary supportive psychotherapy group , and finally no psychiatric treatment group . Scores for anxiety , fatigue , depression and confusion , as measured by the profile of mood states ( POMS ) , were significantly lower after relaxation than before . There were no significant differences in the POMS scores ( except for anger ) among the three groups . These two results suggest that a combination of progressive muscle relaxation and modified autogenic training is a useful method , which can be easily employed in HIV patients without AIDS |
1,355 | 27,929,379 | Nevertheless , it would probably not change the overall conclusion of the review , that “ telemedicine is a promising alternative to conventional therapy ” and that “ behavioural therapy enhanced by telemonitoring appears to be the most suitable mode of intervention ” | The identification of all potentially relevant papers is crucial to the systematic review process .
This requires the literature search to be as sensitive as possible , rather than specific .
However , developing an optimum search strategy for retrieving relevant information from electronic data bases is a challenge .
The rapid growth in the quantity and complexity of the scientific literature has necessitated sophisticated methods to organise and index data , and subsequently to search it .
Electronic data base users rely on the use of keywords and subject headings to search , refine the results and retrieve the information .
The US National Library of Medicine ( NLM ) developed the Medical Subject Heading ( MeSH ) indexing system for cataloguing and categorizing the biomedical scientific documents stored in MEDLINE .
Although MeSH has been shown to facilitate information retrieval from MEDLINE via the PubMed interface , there are certain limitations associated with using MeSH for search ing the literature .
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A search query based solely on MeSH terms will fail to retrieve papers that NLM indexers have indexed insufficiently .
R and omized Controlled Trials ” [ MeSH ] as indicated in the paper ’s search strategy can not identify all r and omised controlled trials ( RCT ) because this MeSH term is used for indexing papers whose topic is an RCT . | Introduction Diabetes self-management education interventions in community gathering places have been moderately effective , but very few studies of intervention effectiveness have been conducted among African Americans with type 2 diabetes . This paper describes a church-based diabetes self-management education intervention for African Americans , a r and omized controlled trial to evaluate the intervention , and baseline characteristics of study participants . Methods A New DAWN : Diabetes Awareness & Wellness Network was conducted among 24 churches of varying size in North Carolina . Each church recruited congregants with type 2 diabetes and design ated a diabetes advisor , or peer counselor , to be part of the intervention team . Participants were enrolled at each church and r and omized as a unit to either the special intervention or the minimal intervention . The special intervention included one individual counseling visit , twelve group sessions , three postcard messages from the participant 's diabetes care provider , and twelve monthly telephone calls from a diabetes advisor . Baseline data included measures of weight , hemoglobin A1c , blood pressure , physical activity , dietary and diabetes self-care practice s , and psychosocial factors . The study to evaluate the intervention ( from enrollment visit to last follow-up ) began in February 2001 and ended in August 2003 . Results Twenty-four churches ( with 201 total participants ) were r and omized . Sixty-four percent of the participants were women . On average , the participants were aged 59 years and sedentary . They had an average of 12 years of education , had been diagnosed with diabetes for 9 years , had a body mass index of 35 , had a hemoglobin A1c level of 7.8 % , and had a reported dietary intake of 39 % of calories from fat . Conclusion A New DAWN is a culturally sensitive , church-based diabetes self-management education program for African Americans with type 2 diabetes that is being evaluated for effectiveness in a r and omized controlled trial . The outcomes of A New DAWN will contribute to the literature on community-based interventions for minority population s and help to inform the selection of approaches to improve diabetes care in this population Existing st and ards of the management of the diabetic patients are not efficient enough , and further improvement is needed . The major objective of this paper is to present and discuss the therapeutic effectiveness of an intensive care telematic system design ed and applied for intensive treatment of pregnant type 1 diabetic women . The developed system operates automatically , every night transferring all the data recorded during the day in the patient 's glucometer memory to a central clinical unit . In order to assess the efficiency of the design ed and developed system , a 3-year r and omized prospect i ve clinical trial was conducted , using the study group and the control group , each consisting of 15 pregnant type 1 diabetic women . All patients were treated by the same diabetologist . In the presented analysis , two indices calculated weekly were used for the assessment of glycemic control : MBG represents mean blood glucose level , and the universal J-index is sensitive to the glycemic level and glycemic variations . The most important results from the study concern : ( a ) better glycemic control in the study group in comparison with the control group during the course of treatment , as assessed by the average differences of the MBG and J indices calculated weekly ( n = 24 ) ( deltaMBG = -3.2 + /- 4.3 mg/dL , p = 0.0016 , deltaJ = -1.4 + /- 2.3 , p = 0.0065 ) ; ( b ) much more similar results in glycemic control among members of the study group compared to each other , than among members of the control group compared to each other , as indicated by significantly lower variations of the applied glycemic control indices ( SDMBG : 11.9 vs. 18.7 mg/dL , p = 0.0498 ; SDJ : 6.5 vs. 10.9 , p = 0.0318 ) ; ( c ) the observed tendency of a better glycemic control for patients with a lower level of intelligence ( IQ < 100 ) supported by the telematic system in comparison with all other assessed groups of patients . The last result was not statistically significant ( p > 0.05 ) . This telematic intensive care system improved the effectiveness of diabetes treatment during pregnancy . It also allows the diabetologist 's strategy to be much more precise than if it were conducted without telematic support . This telematic system is inexpensive and simple in use CONTEXT Level of acuity and number of referrals for home health care have been escalating exponentially . As referrals continue to increase , health care organizations are encouraged to find more effective methods for providing high- quality patient care with cost savings . OBJECTIVE To evaluate the use of remote video technology in the home health care setting as well as the quality , use , patient satisfaction , and cost savings from this technology . DESIGN Quasi-experimental study conducted from May 1996 to October 1997 . SETTING Home health department in the Sacramento , Calif , facility of a large health maintenance organization . PARTICIPANTS Newly referred patients diagnosed as having congestive heart failure , chronic obstructive pulmonary disease , cerebral vascular accident , cancer , diabetes , anxiety , or need for wound care were eligible for r and om assignment to intervention ( n = 102 ) or control ( n = 110 ) groups . INTERVENTION The control and intervention groups received routine home health care ( home visits and telephone contact ) . The intervention group also had access to a remote video system that allowed nurses and patients to interact in real time . The video system included peripheral equipment for assessing cardiopulmonary status . MAIN OUTCOME MEASURES Three quality indicators ( medication compliance , knowledge of disease , and ability for self-care ) ; extent of use of services ; degree of patient satisfaction as reported on a 3-part scale ; and direct and indirect costs of using the remote video technology . RESULTS No differences in the quality indicators , patient satisfaction , or use were seen . Although the average direct cost for home health services was $ 1830 in the intervention group and $ 1167 in the control group , the total mean costs of care , excluding home health care costs , were $ 1948 in the intervention group and $ 2674 in the control group . CONCLUSIONS Remote video technology in the home health care setting was shown to be effective , well received by patients , capable of maintaining quality of care , and to have the potential for cost savings . Patients seemed pleased with the equipment and the ability to access a home health care provider 24 hours a day . Remote technology has the potential to effect cost savings when used to substitute some in-person visits and can also improve access to home health care staff for patients and caregivers . This technology can thus be an asset for patients and providers OBJECTIVE The study 's objective was to assess the effects of automated telephone outreach with speech recognition ( ATO-SR ) on diabetes-related testing . RESEARCH DESIGN AND METHODS We identified 1,200 health plan members who were overdue for diabetes-related testing and r and omly allocated 600 to ATO-SR and 600 to usual care ( no intervention ) . The intervention included three interactive calls encouraging recommended testing . The primary outcome was retinopathy testing , since this was the health plan 's principal goal . Tests for glycemia , hyperlipidemia , and nephropathy were secondary outcomes . RESULTS In total , 232 participants ( 39 % ) verbally responded to the calls . There was no difference between the intervention and the usual care groups in the primary outcome ( adjusted hazard ratio 0.93 [ 95 % CI 0.71–1.22 ] ) and no effect of the intervention on any of the secondary outcomes . CONCLUSIONS Fewer than 40 % of the patients r and omized to ATO-SR interacted verbally with the system . The intervention had no effect on the study 's outcomes OBJECTIVE To report results from YourWay , an Internet-based self-management intervention for adolescents with type 1 diabetes . RESEARCH DESIGN AND METHODS A total of 72 adolescents with type 1 diabetes , ages 13–17 years , were r and omized to a usual-care-plus-Internet support or a usual-care group . The intervention was design ed to enhance problem-solving barriers to self-management . A1C was obtained from medical records , and problem-solving and self-management were obtained via adolescent report . RESULTS Group differences were not statistically significant using intent-to-treat analyses . Using as-treated analyses , adolescents in the treatment condition showed statistically significant improvement in self-management ( d = 0.64 ; P = 0.02 ) and important improvements in problem-solving ( d = 0.30 ; P = 0.23 ) and A1C ( d = −0.28 ; P = 0.27 ) . Mean A1C for the intervention group remained constant ( −0.01 % ) , while the control group increased ( 0.33 % ) . CONCLUSIONS This brief trial suggests that self-management support delivered through a secure website may improve self-management and offset typical decreases in adolescent glycemic control OBJECTIVE We evaluated automated telephone disease management ( ATDM ) with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes in Department of Veterans Affairs ( VA ) clinics . We also compared the results with those of a prior ATDM trial conducted in a county health care system . RESEARCH DESIGN AND METHODS A total of 272 VA patients with diabetes using hypoglycemic medications were r and omized . During the 1-year study period , intervention patients received biweekly ATDM health assessment and self-care education calls , and a nurse educator followed up with patients based on their ATDM assessment reports . Telephone surveys were used to measure patients ' self-care , symptoms , and satisfaction with care . Outpatient service use was evaluated using electronic data bases and self-reports , and glycemic control was measured by HbA1c and serum glucose testing . RESULTS At 12 months , intervention patients reported more frequent glucose self-monitoring and foot inspections than patients receiving usual care and were more likely to be seen in podiatry and diabetes specialty clinics . Intervention patients also were more likely than control patients to have had a cholesterol test . Among patients with baseline HbA1c levels > or = 8 % , mean end-point values were lower among intervention patients than control patients ( 8.7 vs. 9.2 % , respectively ; P = 0.04 ) . Among intervention and control patients with baseline values > or = 9 % , mean end-point values were 9.1 and 10.2 % , respectively ( P = 0.04 ) . At follow-up , intervention patients reported fewer symptoms of poor glycemic control than control patients and greater satisfaction with their health care . CONCLUSIONS This intervention improved the quality of VA diabetes care . Intervention effects for most end points replicated findings from the prior county clinic trial , although intervention-control differences in the current study were smaller because of the relatively good self-care and health status among the current study 's enrollees OBJECTIVE Internet and other interactive technology-based programs offer great potential for practical , effective , and cost-efficient diabetes self-management ( DSM ) programs capable of reaching large numbers of patients . This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program , compared to an enhanced usual care condition . RESEARCH DESIGN AND METHODS A three-arm practical r and omized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program , offered in English and Spanish , compared to enhanced usual care . A heterogeneous sample of 463 type 2 patients was r and omized and 82.5 % completed a 4-month follow-up . Primary outcomes were behavior changes in healthy eating , physical activity , and medication taking . Secondary outcomes included hemoglobin A1c , body mass index , lipids , and blood pressure . RESULTS The Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes ( effect sizes [ d ] for healthy eating = 0.32 ; fat intake = 0.28 ; physical activity= 0.19 ) in both intent-to-treat and complete-cases analyses . These changes did not translate into differential improvements in biological outcomes during the 4-month study period . Added contact did not further enhance outcomes beyond the minimal contact intervention . CONCLUSIONS The Internet intervention meets several of the RE- AIM criteria for potential public health impact , including reaching a large number of persons , and being practical , feasible , and engaging for participants , but with mixed effectiveness in improving outcomes , and consistent results across different subgroups . Additional research is needed to evaluate longer-term outcomes , enhance effectiveness and cost-effectiveness , and underst and the linkages between intervention processes and outcomes OBJECTIVE We evaluated the impact of automated telephone disease management ( ATDM ) calls with telephone nurse follow-up as a strategy for improving outcomes such as mental health , self-efficacy , satisfaction with care , and health-related quality of life ( HRQL ) among low-income patients with diabetes mellitus . RESEARCH DESIGN This was a r and omized , controlled trial . SUBJECTS Two hundred forty-eight primarily English- and Spanish-speaking adults with diabetes enrolled at the time of visits to a county health care system . INTERVENTION In addition to usual care , intervention patients received biweekly ATDM calls with telephone follow-up by a diabetes nurse educator . Patients used the ATDM calls to report information about their health and self-care and to access self-care education . The nurse used patients ' ATDM reports to allocate her time according to their needs . MEASURES Patient-centered outcomes were measured at 12 months via telephone interview . RESULTS Compared with patients receiving usual care , intervention patients at follow-up reported fewer symptoms of depression ( P = 0.023 ) , greater self-efficacy to conduct self-care activities ( P = 0.006 ) , and fewer days in bed because of illness ( P = 0.026 ) . Among English-speaking patients , those receiving the intervention reported greater satisfaction with their health care overall and with the technical quality of the services they received , their choice of providers and continuity of care , their communication with providers , and the quality of their health outcomes ( all P < 0.042 ) . Intervention and control patients had roughly equivalent scores for established measures of anxiety , diabetes-specific HRQL , and general HRQL . CONCLUSIONS This intervention had several positive effects on patient-centered outcomes of care but no measurable effects on anxiety or HRQL Background : Diabetes mellitus is a complex disease with serious complications . Electronic decision support , providing information that is shared and discussed by both patient and physician , encourages timely interventions and may improve the management of this chronic disease . However , it has rarely been tested in community-based primary care . Methods : In this pragmatic r and omized trial , we r and omly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care . The intervention involved shared access by the primary care provider and the patient to a Web-based , colour-coded diabetes tracker , which provided sequential monitoring values for 13 diabetes risk factors , their respective targets and brief , prioritized messages of advice . The primary outcome measure was a process composite score . Secondary outcomes included clinical composite scores , quality of life , continuity of care and usability . The outcome assessors were blinded to each patient ’s intervention status . Results : We recruited sequentially 46 primary care providers and then 511 of their patients ( mean age 60.7 [ st and ard deviation 12.5 ] years ) . Mean follow-up was 5.9 months . The process composite score was significantly better for patients in the intervention group than for control patients ( difference 1.27 , 95 % confidence interval [ CI ] 0.79–1.75 , p < 0.001 ) ; 61.7 % ( 156/253 ) of patients in the intervention group , compared with 42.6 % ( 110/258 ) of control patients , showed improvement ( difference 19.1 % , p < 0.001 ) . The clinical composite score also had significantly more variables with improvement for the intervention group ( 0.59 , 95 % CI 0.09–1.10 , p = 0.02 ) , including significantly greater declines in blood pressure ( −3.95 mm Hg systolic and −2.38 mm Hg diastolic ) and glycated hemoglobin ( −0.2 % ) . Patients in the intervention group reported greater satisfaction with their diabetes care . Interpretation : A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care . ( Clinical Trials.gov trial register no. NCT00813085 . Recent advances in information and communication technology allow the design and testing of new models of diabetes management , which are able to provide assistance to patients regardless of their distance from the health care providers . The M2DM project , funded by the European Commission , has the specific aim to investigate the potential of novel telemedicine services in diabetes management . A multi-access system based on the integration of Web access , telephone access through interactive voice response systems , and the use of palmtops and smart modems for data downloading has been implemented . The system is based on a technological platform that allows a tight integration between the access modalities through a middle layer called the multi-access organizer . Particular attention has been devoted to the design of the evaluation scheme for the system : A r and omized controlled study has been defined , with clinical , organizational , economic , usability , and users ' satisfaction outcomes . The evaluation of the system started in January 2002 . The system is currently used by 67 patients and seven health care providers in five medical centers across Europe . After 6 months of usage of the system no major technical problems have been encountered , and the majority of patients are using the Web and data downloading modalities with a satisfactory frequency . From a clinical viewpoint , the hemoglobin A1c ( HbA1c ) of both active patients and controls decreased , and the variance of HbA1c in active patients is significantly lower than the control ones . The M2DM system allows for the implementation of an easy-to-use , user-tailored telemedicine system for diabetes management . The first clinical results are encouraging and seem to substantiate the hypothesis of its clinical effectiveness The purpose of this study was to evaluate the efficacy and feasibility of a newly developed diabetes patient education program consisting of a three-day hospitalization and a six-month follow-up by telephone counseling for patients with mild type 2 diabetes or impaired glucose tolerance ( IGT ) by a r and omized controlled trial ( RCT ) method . Fifty-two patients with mild type 2 diabetes or IGT ( HbAlc<8 ) were r and omly assigned to either an intervention group or a control group . The current care was continued for the control group and the new education program was provided in addition to the current care for the intervention group . Changes in weight , blood glucose in a 75g-oral glucose tolerance test ( 75g-OGTT ) , and HbAlc were measured in June 1997 as baseline data and again in Dec. 1997 . Scores for knowledge of diabetes , dietary habits , physical activity , health practice index , diabetes quality of life ( DQOL ) , and self-efficacy were also obtained . After six months , the intervention group showed a statistically significant weight loss and blood glucose reduction in the 75g-OGTT test , but the control group did not . A significant improvement in lifestyle was observed in the intervention group , especially in terms of dietary habits and physical activity . The knowledge test scores increased in both groups . There were no significant differences in HbAlc , DQOL , or self-efficacy between the two groups . The results of this study show that the combination of a three-day hospitalization and a six-month follow-up by telephone counseling is effective in metabolic control and improvement of lifestyle for patients with mild type 2 diabetes or IGT . The reasons for the effectiveness were considered to be that l)changes in lifestyle were based on autonomous decision-making ; 2)regular , consistent counseling was provided by the nurse in charge of each patient ; 3)extended follow-up is more effective than initial education in preventing a rebound of weight or metabolic control BACKGROUND Re source barriers complicate diabetes care management . Support from peers may help patients manage their diabetes . OBJECTIVE To compare a reciprocal peer-support ( RPS ) program with nurse care management ( NCM ) . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00320112 ) SETTING 2 U.S. Department of Veterans Affairs health care facilities . PATIENTS 244 men with hemoglobin A(1c ) ( HbA(1c ) ) levels greater than 7.5 % during the previous 6 months . MEASUREMENTS The primary outcome was 6-month change in HbA(1c ) level . Secondary outcomes were changes in insulin therapy ; blood pressure ; and patient reports of medication adherence , diabetes-related support , and emotional distress . INTERVENTION Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals , receive peer communication skills training , and be paired with another age-matched peer patient . Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact . These patients could also participate in optional group sessions at 1 , 3 , and 6 months . Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager . RESULTS Of the 244 patients enrolled , 216 ( 89 % ) completed the HbA(1c ) assessment s and 231 ( 95 % ) completed the survey assessment s at 6 months . Mean HbA(1c ) level decreased from 8.02 % to 7.73 % ( change , -0.29 % ) in the RPS group and increased from 7.93 % to 8.22 % ( change , 0.29 % ) in the NCM group . The difference in HbA(1c ) change between groups was 0.58 % ( P = 0.004 ) . Among patients with a baseline HbA(1c ) level greater than 8.0 % , those in the RPS group had a mean decrease of 0.88 % , compared with a 0.07 % decrease among those in the NCM group ( between-group difference , 0.81 % ; P < 0.001 ) . Eight patients in the RPS group started insulin therapy , compared with 1 patient in the NCM group ( P = 0.020 ) . Groups did not differ in blood pressure , self-reported medication adherence , or diabetes-specific distress , but the RPS group reported improvement in diabetes social support . LIMITATION The study included only male veterans and lasted only 6 months . CONCLUSION Reciprocal peer support holds promise as a method for diabetes care management Objective To explore why reports that seem to describe r and omised controlled trials are sometimes not indexed ( “ tagged ” ) with RCT ( r and omised controlled trial ) [ pt ] ( publication type ) in Medline . Design Cross sectional study . Setting The Cochrane Collaboration and US National Library of Medicine worked together to identify and retag records of r and omised controlled trials with RCT [ pt ] , 1994 to 2006 . Data source Published reports entered into Medline in 2005 . Main outcome measures Type of trial information presented ( for example , main results , design , and methods ) , trial design , and other Medline indexing terms applied . Results 572/591 ( 97 % ) untagged records and 578/594 ( 97 % ) tagged records contained information from r and omised controlled trials . Type of trial information and design differed between untagged and tagged reports . Fewer than half ( 234/572 , 41 % , 95 % confidence interval 37 % to 45 % ) of untagged reports but most tagged reports ( 526/578 , 91 % , 89 % to 93 % ) described the main results of the trial . Untagged reports were more likely than tagged reports to contain information on design and methods , baseline characteristics , long term follow-up , and secondary analyses . Untagged reports of main results were more likely than tagged reports to be from trials using a crossover design ( 36 % v 10 % , difference 25 % , 95 % confidence interval 19 % to 32 % ) . The Medical Subject Heading “ R and omized Controlled Trials ” was the most common clinical trial term applied to untagged reports , although more than half of untagged reports had no indexing related to trials . Conclusion Based on the results for 2005 , at least 3000 records describing r and omised controlled trials but not indexed using RCT [ pt ] may have been entered into Medline between 2006 and 2011 . Research ers and healthcare decision makers relying on using RCT [ pt ] may be missing important evidence in their search es , particularly for design and methods , baseline characteristics , long term follow-up , and secondary data analyses Objective This “ proof of concept ” study aim ed to assess the cost effectiveness of pharmacists giving advice via telephone , to patients receiving a new medicine for a chronic condition , in Engl and . Methods The self-regulatory model ( SRM ) theory was used to guide development of our intervention and used in training pharmacists to adopt a patient-centred approach . Non-adherence to new medicines for chronic conditions develops rapidly so we developed a study intervention in which a pharmacist telephoned patients two weeks after they had started a new medicine for a chronic condition . Patients were included if they were 75 or older , or were suffering from stroke , cardiovascular disease , asthma , diabetes or rheumatoid arthritis , and were r and omized into treatment or control arms . Main outcome measures were non-adherence and cost to the UK NHS , obtained via a question naire sent two months after starting therapy . Cost of the intervention was also included . Incremental cost effectiveness ratios ( ICERs ) were generated . Results Five hundred patients were recruited . At 4-week follow-up , non-adherence was significantly lower in the intervention group ( 9 % vs 16 % , p = 0.032 ) . The number of patients reporting medicine-related problems was significantly lower in the intervention group compared to the control , ( 23 % vs 34 % p = 0.021 ) . Mean total patient costs at 2-month follow-up ( median , range ) were intervention : £ 187.7 ( 40.6 , 4.2–2484.3 ) ; control : £ 282.8 ( 42 , 0–3804 ) ( p < 0.0001 ) . The intervention was dominant ( less costly and more effective ) . If the decision maker is not willing to pay anything for one extra adherent patient , there is still a 90 % probability that the intervention is cost effective . Conclusions These findings suggest that pharmacists can meet patients ’ needs for information and advice on medicines , soon after starting treatment . While a larger trial is needed to confirm that the effect is real and sustained , these initial findings suggest the study intervention may be effective , at least in the short term , with a reduced overall cost to the health provider The aim of this study was to determine whether home telehealth , when integrated with the health facility 's electronic medical record system , reduces healthcare costs and improves quality -of-life outcomes relative to usual home healthcare services for elderly high re source users with complex co-morbidities . Study patients were identified through the medical center 's data base . Intervention patients received home telehealth units that used st and ard phone lines to communicate with the hospital . FDA -approved peripheral devices monitored vital signs and valid question naires were used to evaluate quality -of-life outcomes . Out-of-range data triggered electronic alerts to nurse case managers . ( No live video or audio was incorporated in either direction . ) Templated progress notes facilitated seamless data entry into the patient 's electronic medical record . Participants ( n = 104 ) with complex heart failure , chronic lung disease , and /or diabetes mellitus were r and omly assigned to an intervention or control group for 6 - 12 months . Parametric and nonparametric analyses were performed to compare outcomes for ( 1 ) subjective and objective quality -of-life measures , ( 2 ) health re source use , and ( 3 ) costs . In contrast to the control group , scores for home telehealth subjects showed a statistically significant decrease at 6 months for bed-days-of-care ( p < 0.0001 ) , urgent clinic/emergency room visits ( p = 0.023 ) , and A1C levels ( p < 0.0001 ) ; at 12 months for cognitive status ( p < 0.028 ) ; and at 3 months for patient satisfaction ( p < 0.001 ) . Functional levels and patient-rated health status did not show a significant difference for either group . Integrating home telehealth with the healthcare institution 's electronic data base significantly reduces re source use and improves cognitive status , treatment compliance , and stability of chronic disease for homebound elderly with common complex co-morbidities BACKGROUND To determine whether a Web-based diabetes case management program based in an electronic medical record can improve glycemic control ( primary outcome ) and diabetes-specific self-efficacy ( secondary outcome ) in adults with type 1 diabetes , a pilot r and omized controlled trial was conducted . METHODS A 12-month r and omized trial tested a Web-based case management program in a diabetes specialty clinic . Patients 21 - 49 years old with type 1 diabetes receiving multiple daily injections with insulin glargine and rapid-acting analogs who had a recent A1C > 7.0 % were eligible for inclusion . Participants were r and omized to receive either ( 1 ) usual care plus the nurse-practitioner-aided Web-based case management program ( intervention ) or ( 2 ) usual clinic care alone ( control ) . We compared patients in the two study arms for changes in A1C and self-efficacy measured with the Diabetes Empowerment Scale . RESULTS A total of 77 patients were recruited from the diabetes clinic and enrolled in the trial . The mean baseline A1C among study participants was 8.0 % . We observed a nonsignificant decrease in average A1C ( -0.48 ; 95 % confidence interval -1.22 to 0.27 ; P = 0.160 ) in the intervention group compared to the usual care group . The intervention group had a significant increase in diabetes-related self-efficacy compared to usual care ( group difference of 0.30 ; 95 % confidence interval 0.01 to 0.59 ; P = 0.04 ) . CONCLUSIONS Use of a Web-based case management program was associated with a beneficial treatment effect on self-efficacy , but change in glycemic control did not reach statistical significance in this trial of patients with moderately poorly controlled type 1 diabetes . Larger studies may be necessary to further clarify the intervention 's impact on health outcomes OBJECTIVE We examined whether low-income patients with diabetes were able and willing to use automated telephone disease management ( ATDM ) calls to provide health status information that could improve the quality of their care . RESEARCH DESIGN AND METHODS A total of 252 adults with diabetes , 30 of whom spoke Spanish as their primary language , were enrolled at the time of clinic visits in a Department of Veterans Affairs health care system ( n = 132 ) or a county health care system ( n = 120 ) . Patients received ATDM calls for 12 months and responded to queries using their touch-tone telephones . We examined 1 ) whether patients completed ATDM assessment s consistently over the year and used the calls to report their self-monitored blood glucose ( SMBG ) levels , 2 ) the characteristics of patients most likely to use the system frequently , 3 ) whether patients responded consistently within ATDM assessment s , and 4 ) whether ATDM assessment s differentiated among groups of patients with different clinical profiles at baseline . RESULTS Half of all patients completed at least 77 % of their attempted assessment s , and one-fourth completed at least 91 % . Half of all patients reported SMBG levels during at least 86 % of their assessment s. Patients completed assessment s and reported glucose levels consistently over the year . Health status indicators were the most important determinants of assessment completion rates , while socioeconomic factors were more strongly associated with patients ' likelihood of reporting SMBG data during assessment s. Patients ' responses within assessment s were consistent , and the information they provided during their initial assessment s identified groups with poor glycemic control and other health problems . CONCLUSIONS Most low-income patients with diabetes can and will use ATDM calls as part of their care . The information they provide is reliable and has clinical significance . ATDM calls could improve the information base for diabetes management while relieving some of the pressures of delivering diabetes care under cost constraints |
1,356 | 30,248,232 | Subgroup analysis showed that the erbium laser group , CO2 laser group and fractional CO2 laser group achieved significantly better repigmentation than the control groups .
According to objective and subjective evaluations , treatments for vitiligo are more effective when combined with ablation therapy than when used alone | BACKGROUND AND OBJECTIVES This study aim ed to compare the efficacy of vitiligo treatments with and without ablation therapy . | The present study was design ed to evaluate the effect of combining fractional CO2 laser with narrow-b and ultraviolet B ( NB-UVB ) versus NB-UVB in the treatment of non-segmental vitiligo . The study included 20 patients with non-segmental stable vitiligo . They were divided into two groups . Group I received a single session of fractional CO2 laser therapy on the right side of the body followed by NB-UVB phototherapy twice per week for 8 weeks . Group II received a second session of fractional CO2 laser therapy after 4 weeks from starting treatment with NB-UVB . The vitiligo lesions were assessed before treatment and after 8 weeks of treatment by VASI . At the end of the study period , the vitiligo area score index ( VASI ) in group I decreased insignificantly on both the right ( −2.6 % ) and left ( −16.4 % ) sides . In group II , VASI increased insignificantly on the right ( + 14.4 % ) and left ( + 2.5 % ) sides . Using Adobe Photoshop CS6 extended program to measure the area of vitiligo lesions , group I showed a decrease of −1.02 and −6.12 % in the mean area percentage change of vitiligo lesions on the right and left sides , respectively . In group II the change was + 9.84 and + 9.13 % on the right and left sides , respectively . In conclusion , combining fractional CO2 laser with NB-UVB for the treatment of non-segmental vitiligo did not show any significant advantage over treatment with NB-UVB alone . Further study of this combination for longer duration s in the treatment of vitiligo is recommended Resistant non-segmental vitiligo is difficult to be treated . Ablative erbium-YAG ( Er : YAG ) laser has been used in the treatment of vitiligo , but the ablation of entire epidermis frustrated the compliance of patients . The purpose of this study is to investigate the effects of fractional Er : YAG laser followed by topical betamethasone and narrow b and ultraviolet B ( NB-UVB ) therapy in the treatment of resistant non-segmental vitiligo . The vitiligo lesions of each enrolled patient were divided into four treatment parts , which were all irradiated with NB-UVB . Three parts were , respectively , treated with low , medium , or high energy of Er : YAG laser , followed by topical betamethasone solution application . A control part was spared with laser treatment and topical betamethasone . The treatment period lasted 6 months . The efficacy was assessed by two blinded dermatologists . Treatment protocol with high energy of 1800 mJ/P of fractional Er : YAG laser followed by topical betamethasone solution and in combination with NB-UVB made 60 % patients achieve marked to excellent improvement in white patches . The protocol with medium energy of 1200 mJ/P of laser assisted approximate 36 % patients achieve such improvement . The two protocol s , respectively , showed better efficacies than NB-UVB only protocol . However , fractional Er : YAG laser at low energy of 600 mJ/P did not provide such contributions to the treatment of vitiligo . The fractional Er : YAG laser in combination with topical betamethasone solution and NB-UVB was suitable for resistant non-segmental vitiligo . The energy of laser was preferred to be set at relatively high level BACKGROUND Vitiligo is a pigmentary disorder of skin affecting at least 1 % of the world population of all races in both sexes . Its importance is mainly due to subsequent social and psychological problems rather than clinical complications . Various treatment choices are available for vitiligo ; however , laser-based courses have shown to give more acceptable results . OBJECTIVE The aim of this trial was to evaluate the efficacy of Er : YAG laser as a supplementary medicine to topical 5FU and clobetasol in vitiligo patients . METHODS Two comparable vitiligo patches from 38 eligible patients were r and omized to receive topical 5FU and clobetasol in control group and additional Er : YAG laser in intervention group . Major outcomes of interest were the size of patch and pigmentation score at r and omization and 2 and 4 months after therapy . RESULTS Final sample included 18 ( 47 % ) male patients and age of 35.66±8.04 . The performance Er : YAG group was superior in all sites . Reduction in the size of patches was greater in Er : YAG group ( p-value=.004 ) . Also , this group showed a higher pigmentation scores in the trial period than control group ( p-value<.001 ) . CONCLUSIONS Greater reduction in the size and increase in pigmentation score was seen in Er : YAG group especially for short periods after therapy and repeating laser sessions may help improving final outcomes . Er : AYG could help in reducing complications of long-term topical treatments , achieving faster response , and improving patient adherence Facial vitiligo is associated with considerable psychological impact . The management is challenging and requires multidisciplinary treatment . Adding fractional carbon dioxide ( CO2 ) to the conventional treatment has been reported as an effective modality . This study aim ed to evaluate the efficacy of combined fractional CO2 laser , targeted ultraviolet B ( UVB ) phototherapy , and topical steroid on facial vitiligo . A prospect i ve , r and omized , split face study was conducted on 14 patients with symmetrical non-segmental facial vitiligo . Ten sessions of fractional CO2 laser was performed on the lesions on one side of face with 2-week interval . Immediately after laser , the lesions on both side of face were treated with 10 sessions of 2-week interval targeted UVB phototherapy and twice daily application of topical 0.05 % clobetasol propionate cream . The patients were followed up for 12 weeks after the last treatment . Clinical improvement was grade d by blinded dermatologists and patients using a quartile grading scale . Twelve out of 14 patients completed the study . The degree of improvement was not different between both sides in nine patients . One patient showed more improvement on the combined laser side , and two patients showed inferior results on the combined laser side . Two patients with lesser improvement on the laser-treated side had positive Koebner phenomenon on the non-facial area . The combined treatment with laser , targeted UVB , and topical steroids are not superior to targeted UVB and topical steroids in facial vitiligo . Furthermore , laser may retard the response to the st and ard treatment in patients with Koebner phenomenon on non-treated areas Despite the multiple treatment modalities available for vitiligo , none of them gives satisfactory results in the periungual type . In this study we tried to explore and evaluate the effects of the combination treatment of erbium : YAG laser resurfacing and topical 5-flurouracil in periungual vitiligo . Nine adult patients presenting with periungual vitiligo lesions were included in this prospect i ve left-right comparative study . The desirable inflammation was achieved after a mean of 4.7 days of 5-flurouracil application . The mean re-epithelization time in the treatment sessions was 11.3 days . The patients received a mean of 3.4 sessions in a mean duration of 7.6 months . The mean overall response to therapy in the treated group was 47.8 % while in the control group it was 1.1 % ( P < 0.0001 ) . No side effects necessitated the stoppage of treatment . This study points to the efficacy and safety of this combination in the treatment of periungual vitiligo BACKGROUND Fractional CO2 laser and autologous hair transplantation are independently effective in the treatment of refractory and stable vitiligo . OBJECTIVE The authors ' purpose was to evaluate the therapeutic efficacy of fractional CO2 laser pretreatment compared with autologous hair transplantation and phototherapy alone for refractory and stable vitiligo . METHODS A total of 20 patients with refractory and stable vitiligo were enrolled from our clinic . Resistant lesions r and omly divided into 2 regions as follows : ( 1 ) Part A : fractional CO2 laser pretreatment followed by autologous transplantation and phototherapy , and ( 2 ) Part B : autologous transplantation and phototherapy alone . Five days after fractional CO2 laser application to Part A , both treatment regions received a transplant of scalp grafts . On Day 11 , the entire lesion was exposed to narrow-b and UVB phototherapy , twice a week for 12 weeks . The diameter of perifollicular repigmentation was measured monthly with a caliper . RESULTS Perifollicular repigmentation was detectable surrounding 74 % of grafted hair follicles by Month 3 . Furthermore , Part A demonstrated a significantly greater diameter of repigmentation with 6.6 ± 5.8 mm in Part A compared with 4.3 ± 1.8 mm in Part B ( p = < .001 ) . CONCLUSION In this study , our results demonstrate improved efficacy of autologous hair transplantation and narrow-b and UVB with fractional CO2 laser pretreatment in refractory and stable vitiligo OBJECTIVE To compare the efficacy and safety of using a combination of fluticasone propionate ( FP ) and UV-A with that of either drug used alone in the long-term treatment of vitiligo . DESIGN Prospect i ve , r and omized , controlled , left-right comparison study . Repigmentation was judged by a single dermatologist ( L.N.-K. ) and skin thickness was scored by a pathologist ( using biopsy sample s ) , a dermatologist ( L.N.-K. ) ( visually ) , and patients ( using a st and ard question naire ) . SETTING Netherl and s Institute for Pigmentary Disorders , Amsterdam . PATIENTS Patients with lesions on arms , legs , and trunk were treated on 2 symmetrical lesions for 9 months with FP alone and a combination of FP and UV-A ( FP group ) or with UV-A alone and a combination of FP and UV-A ( UV-A group ) . Fluticasone propionate cream was applied once daily at about bedtime , and UV-A ( 10 J/cm2 ) exposure was twice a week . Patients attended the clinic at 3-month intervals . RESULTS One hundred thirty-five patients were included , 96 of whom were evaluable after 9 months . Patients not reaching the end point withdrew because of insufficient repigmentation ( n = 23 ) , decreased motivation ( n = 11 ) , or protocol violations ( n = 5 ) . No patient ( irrespective of whether they withdrew ) experienced any adverse effects . The FP and UV-A groups were comparable with respect to sex , age , and location of lesions . On average , combination treatment was 3 times more effective than either UV-A or FP treatment alone . In the FP group , no atrophy was seen after 9 months with either treatment . In the UV-A group , a little atrophy was detected twice : as well during UV-A treatment alone as during combination treatment . CONCLUSIONS Combination treatment with FP and UV-A is much more effective in reaching complete repigmentation than are FP and UV-A used alone , but large inter-individual differences occur . Fluticasone propionate , UV-A , and a combination of FP and UV-A seem to be safe for long-term treatment of vitiligo BACKGROUND AND OBJECTIVE Conventional treatment of vitiligo on h and s and feet often produces an unsatisfactory result . Various ablative treatment methods were tried with favorable results in facial , neck , and truncal areas . The aim of this study is to evaluate the efficacy and safety of combined fractional CO2 laser , narrowb and UVB ( NB-UVB ) phototherapy , and topical clobetasol propionate in managing stable vitiligo in difficult-to-treat areas . STUDY DESIGN A prospect i ve r and omized-intraindividual study was conducted on 27 patients with 27 pair-lesions of non-segmental vitiligo on both h and s. The lesions were r and omized to receive treatment with fractional CO2 laser , NB-UVB phototherapy , and 0.05 % clobetasol propionate cream ( Group A ) or NB-UVB phototherapy and 0.05 % clobetasol propionate cream ( Group B ) . Fractional CO2 laser was performed at 1-week interval for 10 sessions . NB-UVB phototherapy was administered twice weekly for 20 sessions . Patients were evaluated 12 weeks after the last treatment . Outcome was evaluated objective ly based on st and ard digital photographs , patient satisfaction , and adverse events . RESULTS Twenty-six patients completed the study . Six vitiligious lesions ( 23.1 % ) in group A achieved good to excellent repigmentation compared with one lesion ( 3.9 % ) in group B ( P = 0.065 ) . The overall mean improvement score was 1.35 ( ± 1.38 ) in group A and 0.50 ( ± 0.95 ) in group B ( P = 0.0004 ) . Patients ' satisfaction score was significantly higher for the lesions in group A than group B. Lesions on the dorsum of the h and showed a higher response rate than those on the fingers . No serious side-effects were noted . CONCLUSION This study demonstrates that adding fractional CO2 laser treatment to NB-UVB phototherapy and topical steroids improves the repigmentation rate of vitiliginous lesions on h and s in some patients . This technique may be offered to vitiligo patients who are unresponsive to other treatments The aim of this study is to evaluate the use of fractional carbon dioxide laser ( CO2 ) with betamethasone and salicylic acid solution in the treatment of patients with refractory vitiligo in h and s. Each h and of the patient was r and omly assigned to one of two groups : lesion treated with fractional carbon dioxide laser associated with betamethasone and salicylic acid solution administration or lesion treated only with betamethasone and salicylic acid solution . We conclude that combined treatment with fractional carbon dioxide laser and betamethasone associated with salicylic acid solution could effectively and safely be used in the treatment of refractory vitiligo BACKGROUND Multiple treatment options are introduced in treatment of vitiligo but the response is unsatisfactory . OBJECTIVE In this prospect i ve , r and omized , comparative trial , we studied the effect of combined treatment with fractional carbon dioxide ( CO2 ) laser , platelet-rich plasma ( PRP ) injection , and narrowb and ultraviolet B ( NB-UVB ) for stable nonsegmental vitiligo regarding repigmentation grade , patient 's satisfaction , and side effects . METHODS Eighty adult patients with localized nonsegmental vitiligo were enrolled in this study . The patients were r and omly categorized to receive 4 lines of treatment ; fractional CO2 laser , PRP , combined fractional CO2 laser and PRP , and combined fractional CO2 laser and NB-UVB . The treatment period was 2 months . Patients were clinical ly evaluated 3 months after the last treatment . Outcome was evaluated by 5-point scale for repigmentation , 10-point visual analog scale for patient 's satisfaction , and side effects . RESULTS Laser and PRP group achieved the best results regarding repigmentation and patient 's satisfaction . Sixty percent of the patients developed repigmentation > 50 % and 40 % of patients developed repigmentation > 75 % . In laser and NB-UVB group , 5 % developed repigmentation > 75 % and 25 % developed repigmentation > 50 % . Only 10 % of patients developed repigmentation > 75 % in laser group and only 20 % of patients developed repigmentation > 75 % in PRP group . CONCLUSIONS Combination of fractional CO2 laser with PRP injection is a promising treatment for vitiligo , followed by combination of fractional CO2 laser with NB-UVB phototherapy . Both fractional CO2 laser and PRP injection gave poor results if they received alone BACKGROUND Only a few , small double-blind clinical trials have been reported for the treatment of vitiligo . Narrowb and -ultraviolet B ( NB-UVB ) is an established form of treatment for this condition . Tacrolimus ointment is assumed to have an effect in some patients . OBJECTIVES To assess the additive effect of tacrolimus ointment ( 0.1 % ) once daily in vitiligo patients treated with NB-UVB . METHODS In a r and omized double-blind trial , patients with stable symmetrical vitiligo were treated half-side with tacrolimus ointment ( 0.1 % ) and half-side with placebo ointment . Whole body NB-UVB was given twice or thrice weekly for at least 3 months . As a morphometric device , Visitrak(TM ) was used to measure the area of the vitiligo target lesions . RESULTS Of 40 patients , 27 had a better effect on the tacrolimus side . The degree of improvement was significantly better on the tacrolimus side ( P = 0.005 ) . The median reduction in the target lesion areas was 42.1 % on the tacrolimus side and 29 % on the placebo side . There was a correlation between the effect and the number of topical tacrolimus applications ( P = 0.044 ) , but there was no correlation with the number of UV treatments given ; neither any significance of gender , age , skin type , duration of disease , familial occurrence of vitiligo nor presence of other autoimmune disease or atopy was observed . We found a significant reduction in the patients ' subjective disease impact during the treatment period ( P < 0.001 ) . CONCLUSION According to this study , the combination of NB-UVB and tacrolimus ointment ( 0.1 % ) is more effective than UV treatment alone in patients with vitiligo . The effect is tacrolimus total dose-dependent Background Stable non-segmental vitiligo is often resistant to conventional therapies . Objectives The purpose of this study was to investigate the effect of three types of fractional lasers in the treatment of stable nonsegmental vitiligo . Material s & methods Twenty patients were enrolled in the study . The vitiligo lesions of each patient were divided into four treatment parts , and all parts were treated with narrowb and ultraviolet-B ( NB-UVB ) . Three of the four parts were respectively treated with three types of fractional lasers ( two ablative 10,600-nm CO2 lasers and one non-ablative 1,565-nm laser ) , followed by topical betamethasone solution application . The treatment period lasted six months . Efficacy and satisfaction were respectively assessed by dermatologists and patients . Results The ablative CO2 lasers , in combination with topical betamethasone solution and NB-UVB , achieved marked to excellent improvement on white patches assessed by dermatologists . Patients showed high satisfaction scores for the treatments . The non-ablative 1,565-nm fractional laser did not provide any further benefit in the treatment of vitiligo . No severe adverse events developed for any of the treatments . Conclusion The treatment protocol with ablative CO2 lasers , in combination with topical betamethasone solution and NB-UVB , was suitable for stable non-segmental vitiligo . For vitiligo , the ablative fractional CO2 laser is more effective than the non-ablative fractional laser Recently , topical immunomodulators have been successfully used in monotherapy or in combination with other therapeutic modalities in vitiligo . To determine whether combination pimecrolimus 1 % cream and microdermabrasion enhances response time and repigmentation rate in children with vitiligo . Sixty-five children diagnosed with vitiligo enrolled in this r and omized placebo-controlled study . Three vitiliginous patches were chosen in each patient . The first lesion was treated by pimecrolimus 1 % cream . On the second lesion after doing microdermabrasion on day 1 , pimecrolimus 1 % cream was applied . On the third lesion placebo was applied . The course of treatment was 10 days . Vitiliginous patches were measured at baseline , day 10 , and months 1 , 2 , and 3 . Sixty patients completed the 3-month study period . Clinical response ( pigmentation > 50 % ) was observed in 60.4 % of the patches treated by combined pimecrolimus plus microdermabrasion at the third month of follow-up , compared with 32.1 % and 1.7 % for pimecrolimus alone and placebo , respectively ( p = 0.000 ) . No significant side effect was observed . Microdermabrasion exerts an additive effect in enhancing the rate and degree of repigmentation by pimecrolimus . This new combined approach appears to be safe and effective in childhood vitiligo Abstract Background : Acral vitiligo ( AV ) is resistant to treatment . Aim : To evaluate efficacy and safety of combining carbon dioxide ( CO2 ) laser and 5-fluorouracil ( 5FU ) in treating AV . Methods : This study included 68 adult patients with AV . After r and omly assigning patients into 3 groups , patients in group I were treated using 5FU , group II were treated using CO2 laser , and group III were treated using CO2 laser followed by 5FU for a maximum period of 5 months . The lesions were then evaluated both qualitatively and quantitatively . Results : Almost half ( 49.8 % ) of the lesions in group III achieved G4 , and 6.1 % of lesions achieved G3 re-pigmentation . This response was statistically significantly higher than that in the other two groups . This was not achieved in periungual areas in the h and s and feet . The pain was tolerable during sessions or at sites of 5FU application . Transient hyperpigmentation , brownish spot on nail plates , itching , and infection were temporary side effects ; however , Koebnerization was not detected . Conclusion : We concluded that prior use of CO2 laser skin ablation , followed by 5FU application for AV is a safe and tolerable technique that improves the outcome and increases patient compliance |
1,357 | 30,410,636 | Many studies report the association between type I interferon signature gene expression and response to therapy | In the era of precision medicine , transcriptome analysis of whole gene expression is an essential technology .
While DNA microarray has a limited dynamic range and a problem of background hybridization , RNA sequencing ( RNA-seq ) has a broader dynamic range and a lower background signal that increase the sensitivity and reproducibility .
While transcriptome analyses in rheumatoid arthritis ( RA ) have generally focused on whole peripheral blood mononuclear cells ( P BMC ) , analyses of detailed cell subsets have an increased need for underst and ing the pathophysiology of disease because the involvement of CD4 + T cells in the pathogenesis of RA has been established .
Transcriptome analysis of detailed CD4 + T cell subsets or neutrophils shed new light on the pathophysiology of RA .
There are several analyses about the effect of biological treatment . | Objective Tofacitinib is an oral Janus kinase ( JAK ) inhibitor for the treatment of rheumatoid arthritis ( RA ) . The pathways affected by tofacitinib and the effects on gene expression in situ are unknown . Therefore , tofacitinib effects on synovial pathobiology were investigated . Methods A r and omised , double-blind , phase II serial synovial biopsy study ( A3921073 ; NCT00976599 ) in patients with RA with an inadequate methotrexate response . Patients on background methotrexate received tofacitinib 10 mg twice daily or placebo for 28 days . Synovial biopsies were performed on Days -7 and 28 and analysed by immunoassay or quantitative PCR . Clinical response was determined by disease activity score and European League Against Rheumatism ( EULAR ) response on Day 28 in A3921073 , and at Month 3 in a long-term extension study ( A3921024 ; NCT00413699 ) . Results Tofacitinib exposure led to EULAR moderate to good responses ( 11/14 patients ) , while placebo was ineffective ( 1/14 patients ) on Day 28 . Tofacitinib treatment significantly reduced synovial mRNA expression of matrix metalloproteinase (MMP)-1 and MMP-3 ( p<0.05 ) and chemokines CCL2 , CXCL10 and CXCL13 ( p<0.05 ) . No overall changes were observed in synovial inflammation score or the presence of T cells , B cells or macrophages . Changes in synovial phosphorylation of signal transducer and activator of transcription 1 ( STAT1 ) and STAT3 strongly correlated with 4-month clinical responses ( p<0.002 ) . Tofacitinib significantly decreased plasma CXCL10 ( p<0.005 ) at Day 28 compared with placebo . Conclusions Tofacitinib reduces metalloproteinase and interferon-regulated gene expression in rheumatoid synovium , and clinical improvement correlates with reductions in STAT1 and STAT3 phosphorylation . JAK1-mediated interferon and interleukin-6 signalling likely play a key role in the synovial response . Trial registration number NCT00976599 Introduction Rheumatoid arthritis ( RA ) is a complex and clinical ly heterogeneous autoimmune disease . Currently , the relationship between pathogenic molecular drivers of disease in RA and therapeutic response is poorly understood . Methods We analyzed synovial tissue sample s from two RA cohorts of 49 and 20 patients using a combination of global gene expression , histologic and cellular analyses , and analysis of gene expression data from two further publicly available RA cohorts . To identify c and i date serum biomarkers that correspond to differential synovial biology and clinical response to targeted therapies , we performed pre-treatment biomarker analysis compared with therapeutic outcome at week 24 in serum sample s from 198 patients from the ADACTA ( ADalimumab ACTemrA ) phase 4 trial of tocilizumab ( anti-IL-6R ) monotherapy versus adalimumab ( anti-TNFα ) monotherapy . Results We documented evidence for four major phenotypes of RA synovium – lymphoid , myeloid , low inflammatory , and fibroid - each with distinct underlying gene expression signatures . We observed that baseline synovial myeloid , but not lymphoid , gene signature expression was higher in patients with good compared with poor European league against rheumatism ( EULAR ) clinical response to anti-TNFα therapy at week 16 ( P = 0.011 ) . We observed that high baseline serum soluble intercellular adhesion molecule 1 ( sICAM1 ) , associated with the myeloid phenotype , and high serum C-X-C motif chemokine 13 ( CXCL13 ) , associated with the lymphoid phenotype , had differential relationships with clinical response to anti-TNFα compared with anti-IL6R treatment . sICAM1-high/CXCL13-low patients showed the highest week 24 American College of Rheumatology ( ACR ) 50 response rate to anti-TNFα treatment as compared with sICAM1-low/CXCL13-high patients ( 42 % versus 13 % , respectively , P = 0.05 ) while anti-IL-6R patients showed the opposite relationship with these biomarker subgroups ( ACR50 20 % versus 69 % , P = 0.004 ) . Conclusions These data demonstrate that underlying molecular and cellular heterogeneity in RA impacts clinical outcome to therapies targeting different biological pathways , with patients with the myeloid phenotype exhibiting the most robust response to anti-TNFα . These data suggest a path to identify and vali date serum biomarkers that predict response to targeted therapies in rheumatoid arthritis and possibly other autoimmune diseases . Trial registration Clinical Trials.gov BACKGROUND Effective new therapies are needed for rheumatoid arthritis . Current therapies target the products of activated macrophages ; however , T cells also have an important role in rheumatoid arthritis . A fusion protein -- cytotoxic T-lymphocyte-associated antigen 4-IgG1 (CTLA4Ig)--is the first in a new class of drugs known as costimulation blockers being evaluated for the treatment of rheumatoid arthritis . CTLA4Ig binds to CD80 and CD86 on antigen-presenting cells , blocking the engagement of CD28 on T cells and preventing T-cell activation . A preliminary study showed that CTLA4Ig may be effective for the treatment of rheumatoid arthritis . METHODS We r and omly assigned patients with active rheumatoid arthritis despite methotrexate therapy to receive 2 mg of CTLA4Ig per kilogram of body weight ( 105 patients ) , 10 mg of CTLA4Ig per kilogram ( 115 patients ) , or placebo ( 119 patients ) for six months . All patients also received methotrexate therapy during the study . The clinical response was assessed at six months with use of the criteria of the American College of Rheumatology ( ACR ) , which define the response according to its extent : 20 percent ( ACR 20 ) , 50 percent ( ACR 50 ) , or 70 percent ( ACR 70 ) . Additional end points included measures of the health-related quality of life . RESULTS Patients treated with 10 mg of CTLA4Ig per kilogram were more likely to have an ACR 20 than were patients who received placebo ( 60 percent vs. 35 percent , P<0.001 ) . Significantly higher rates of ACR 50 and ACR 70 responses were seen in both CTLA4Ig groups than in the placebo group . The group given 10 mg of CTLA4Ig per kilogram had clinical ly meaningful and statistically significant improvements in all eight subscales of the Medical Outcomes 36-Item Short-Form General Health Survey . CTLA4Ig was well tolerated , with an overall safety profile similar to that of placebo . CONCLUSIONS In patients with active rheumatoid arthritis who were receiving methotrexate , treatment with CTLA4Ig significantly improved the signs and symptoms of rheumatoid arthritis and the health-related quality of life . CTLA4Ig is a promising new therapy for rheumatoid arthritis Objective Despite the fact that rituximab depletes B cells in all treated patients with RA , not all patients show a favourable clinical response . The goal of this study was to provide insight into pharmacological changes in peripheral blood that are associated with clinical response to rituximab . Methods Gene expression profiling was performed on peripheral blood RNA of 13 patients with RA ( test group ) using Illumina HumanHT beadchip microarrays . An independent group of nine patients was used for validation using TaqMan quantitative PCR . Clinical responder status was determined after 6 months using change in 28-joint Disease Activity Score ( ΔDAS28 ) and European League Against Rheumatism ( EULAR ) response criteria . Significance analysis of microarrays and ontology analysis were used for data analysis and interpretation . Results Pharmacogenomic analyses demonstrated marked interindividual differences in the pharmacological responses at 3 and 6 months after start of treatment with rituximab . Interestingly , only differences in the regulation of type I interferon (IFN)-response genes after 3 months correlated with the ΔDAS28 response . Good responders ( ∆DAS>1.2 ; n=7 ) exhibited a selective increase in the expression of type I IFN-response genes , whereas this activity was unchanged or hardly changed in non-responders ( ∆DAS<1.2 ; n=6 ) ( p=0.0040 at a cut-off of 1.1-fold induction ) . Similar results were obtained using EULAR response criteria . These results were vali date d in an independent cohort of nine patients ( five non-responders and four responders , p=0.0317 ) . Conclusions A good clinical response to rituximab in RA is associated with a selective drug-induced increase in type I IFN-response activity in patients with RA . This finding may provide insight in the biological mechanism underlying the therapeutic response to rituximab The aim of this prospect i ve multicenter study was to identify biomarkers that can be used to predict therapeutic responses to tocilizumab in patients with rheumatoid arthritis ( RA ) |
1,358 | 31,044,364 | Based on the current evidence , the use of LLLT for pain control in postendodontic therapy may be promising . | The aim of this study was to assess the effectiveness of low-level laser therapy ( LLLT ) for pain management after root canal treatment or retreatment . | Objective The aim of this prospect i ve , r and omized , clinical study was to assess the effect of photobiomodulation therapy ( PBM ) with low-level laser irradiation ( LLLI ) on postoperative pain after endodontic treatment . Material s and methods Sixty patients , diagnosed with irreversible pulpitis in lower molar teeth , participated in the study . All treatments were performed by a single operator . Participants were r and omly divided into two groups : in the experimental group ( EG ) , endodontic treatment was performed with a reciprocating system , immediately followed by PBM with LLLI ; and only endodontic treatment was performed in the control group ( CG ) . Postoperative pain was assessed by a second examiner , who was blinded , using two scales : verbal rating scale ( VRS ) and numerical rating scale ( NRS ) . Assessment was carried out at 6 , 12 , and 24 h after treatment . Data were analyzed using chi-squared , Fisher ’s exact , Mann-Whitney tests , ordinal , and non-parametric regression analyses . Results For the prevalence of pain , the difference between the groups was significant for the evaluations performed after 6 h ( p = 0.04 ) and 24 h ( p = 0.02 ) . The difference after 24 h remained significant after stratification by sex and extrusion of filling material . Increased pain intensity was associated with extrusion of root canal filling material to the periapical region in the two scales used . Conclusion The effect of PBM therapy after endodontic treatment showed a significant decreasein prevalence of postoperative pain . Clinical relevance The PBM reduces the prevalence of postoperative pain and may benefit patients who need endodontic treatment Introduction : The aim of this r and omized clinical trial was to evaluate the influence of rotary or reciprocating retreatment techniques on the incidence , intensity , duration of postoperative pain , and medication intake . Methods : After power analysis calculations , 65 patients who needed endodontic retreatment were r and omly assigned to 1 of 2 groups according to the instrumentation system used : Mtwo ( VDW , Munich , Germany ) or Reciproc ( VDW ) . Retreatments were performed in a single visit by an endodontic specialist . Participants were asked to rate the incidence and intensity of the postoperative pain on a verbal rating scale 24 , 48 , and 72 hours after treatment . Patients were also asked to record the number of prescribed analgesic medication tablets ( ibuprofen 400 mg ) taken . A logistic regression analysis was used to assess both the incidence and duration of pain . Differences in the intensity of pain were analyzed using the ordinal ( linear ) chi‐square test , and the Mann‐Whitney U test was used to assess differences in the intake of analgesic medication between groups . Results : No statistically significant difference was found among the 2 groups in relation to postoperative pain or analgesic medication intake at the 3 time points assessed ( P > .05 ) . Multivariate analysis showed a significantly higher incidence of pain after 24 hours when preoperative pain was present and a significantly longer duration of pain for men than women independently of the retreatment technique used . Conclusions : The reciprocating system and the continuous rotary system were found to be equivalent regarding the incidence , intensity , duration of postoperative pain , and intake of analgesic medication OBJECTIVES The aim of this prospect i ve study was to investigate the correlation between the intensity of preoperative pain and the presence of postoperative pain , taking into account the variables sex , tooth type , arch , and tooth vitality . METHODS Two hundred and seventy patients with pulpal pathology who were scheduled for routine endodontic treatment were enrolled in this study . Conventional endodontic treatment was carried out in a single visit . The chemomechanical preparation of root canals was performed with ProTaper instruments , and canals were obturated with a warm gutta-percha obturation technique . A structured question naire was used to record data on sex , age , type of tooth , location and pulp diagnosis . Patients were asked to record their preoperative and postoperative pain using a 10-cm visual analogue scale ( VAS ) . Postoperative pain and the need for analgesic consumption were assessed at 4 , 8 , 16 , 24 , 48 and 72h post-treatment . The data were analyzed using the Mann-Whitney U and chi-square test , and the significance was set at P<.05 . RESULTS The mean level of pain after root canal treatment was 2.58±2.80 on a VAS between 0 and 10 . Variables that were associated with a higher preoperative pain intensity ( female , m and ible and molar ) also had a higher value of postoperative pain ( P>.05 ) . CONCLUSIONS Within the limitations of this study , it can be concluded that the presence of preoperative pain is the variable that most influences the prevalence of postoperative pain . CLINICAL SIGNIFICANCE Pain management should be an integral part of dental treatment . The present study analyses the incidence of postoperative pain that should be expected by patients with different intensity of pain before root canal treatment Some patients experience severe pain following root canal therapy ( RCT ) despite advancements in care . We sought to identify factors , which can be measured preoperatively , that predict this negative outcome so that future research may focus on preemptive steps to reduce postoperative pain intensity . Sixty-two practitioners ( 46 general dentists and 16 endodontists ) who are members of the National Dental Practice -Based Research Network enrolled patients receiving RCT for this prospect i ve observational study . Baseline data collected from patients and dentists were obtained before treatment . Severe postoperative pain was defined based on a rating of ≥7 on a scale from 0 ( no pain ) to 10 ( pain as bad as can be ) for the worst pain intensity experienced during the preceding week , and this was collected 1 wk after treatment . Multiple logistic regression analyses were used to develop and vali date the model . A total of 708 patients were enrolled during a 6-m period . Pain intensity data were collected 1 wk postoperatively from 652 patients ( 92.1 % ) , with 19.5 % ( n = 127 ) reporting severe pain . In multivariable modeling , baseline factors predicting severe postoperative pain included current pain intensity ( odds ratio [ OR ] , 1.15 ; 95 % confidence interval [ CI ] , 1.07 to 1.25 ; P = 0.0003 ) , number of days in the past week that the subject was kept from their usual activities due to pain ( OR , 1.32 ; 95 % CI , 1.13 to 1.55 ; P = 0.0005 ) , pain made worse by stress ( OR , 2.55 ; 95 % CI , 1.22 to 5.35 ; P = 0.0130 ) , and a diagnosis of symptomatic apical periodontitis ( OR , 1.63 ; 95 % CI , 1.01 to 2.64 ; P = 0.0452 ) . Among the factors that did not contribute to predicting severe postoperative pain were the dentist ’s specialty training , the patient ’s age and sex , the type of tooth , the presence of swelling , or other pulpal and apical endodontic diagnoses . Factors measured preoperatively were found to predict severe postoperative pain following RCT . Practitioners could use this information to better inform patients about RCT outcomes and possibly use different treatment strategies to manage their patients ( Clinical trials.gov NCT01201681 ) BACKGROUND To investigate and compare the post-obturation pain after one-visit and two-visit root canal treatment in non-vital anterior teeth . MATERIAL S & METHODS One hundred forty eight patients requiring root canal therapy on permanent anterior non-vital teeth with single root were included in this study . Patients were r and omly assigned to either the one-appointment or the twoappointment group . The st and ardized protocol for all the teeth involved local anesthesia , isolation and access , engine-driven rotary nickel-titanium canal instrumentation with 2.5 % NaOCl irrigation and obturation . Teeth in group 1 ( n = 74 ) were obturated during the first appointment by using laterally condensed gutta-percha and resin sealer . Teeth in group 2 ( n = 74 ) were given closed dressing and were obturated during the second appointment , 7 to 14 days later . A modified Visual Analogue Scale was used to measure pain after 6 hours , 24 hours , 48 hours and 7 days after the treatment . Statistical analysis was done to compare groups at each interval by using an independent- sample s t test . RESULTS The incidence and intensity of post-obturation pain in both Group ' A ' and Group ' B ' gradually reduced over the study period . When the incidence of pain was compared in the single and two visit group , it was found that the single-visit group experienced slightly less pain than the two-visit group during all study intervals , but the difference found was not statistically significant . CONCLUSION There was no difference in postoperative pain between patients treated in only one appointment and patients treated in two appointments . The majority of patients in both groups reported no pain or only minimal pain after 7 days of treatment . How to cite the article : Rao KN , K and aswamy R , Umashetty G , Rathore VP , Hotkar C , Patil BS . Post-Obturation pain following one-visit and two-visit root canal treatment in necrotic anterior teeth . J Int Oral Health 2014;6(2):28 - 32 Aim The aim of this study was to evaluate the effect of simultaneous length control during root canal preparation on postoperative pain compared with separate working length determination and root canal preparation . The design was a parallel‐group , r and omized , controlled trial with 2 arms . Methods Forty‐four molar teeth were r and omly divided into 2 groups ( n = 22 ) , a control group ( separate length determination and root canal preparation ) and a simultaneous length control during root canal preparation group . The following variables were recorded : age ; gender ; tooth number ; preoperative pain on the visual analog scale ; pain level on days 1 , 3 , 5 , and 7 ; and analgesic intake after the procedure and initial/final percussion pain . The data were analyzed with the χ2 test , independent sample s t test , and Mann‐Whitney U test . Results The simultaneous length control during root canal preparation group result ed in lower postoperative pain levels on day 1 than did the control group ( P < .05 ) . Despite 2 patients ’ intake of postoperative analgesics in the control group , no patient needed to use postoperative analgesics in the simultaneous length control during root canal preparation group ( P > .05 ) . Conclusions Simultaneous length control during root canal preparation as a non‐pharmacologic strategy for reducing postoperative pain is a beneficial technique for preventing postoperative pain Phototherapy with low-level laser therapy ( LLLT ) and light-emitting diode therapy ( LEDT ) has arisen as an interesting alternative to drugs in treatments of musculoskeletal disorders . However , there is a lack of studies investigating the effects of combined use of different wavelengths from different light sources like lasers and light-emitting diodes ( LEDs ) in skeletal muscle disorders . With this perspective in mind , this study aim ed to investigate the effects of phototherapy with combination of different light sources on nonspecific knee pain . It was performed a r and omized , placebo-controlled , double-blinded clinical trial . Eighty-six patients rated 30 or greater on the pain visual analogue scale ( VAS ) were recruited and included in study . Patients of LLLT group received 12 treatments with active phototherapy ( with 905 nm super-pulsed laser and 875 and 640 nm LEDs , Manufactured by Multi Radiance Medical , Solon , OH , USA ) and conventional treatment ( physical therapy or chiropractic care ) , and patients of placebo group were treated at same way but with placebo phototherapy device . Pain assessment s ( VAS ) were performed at baseline , 4th , 7th , and 10th treatments , after the completion of treatments and at 1-month follow-up visit . Quality of life assessment s ( SF-36 ® ) were performed at baseline , after the completion of treatments and at 1-month follow-up visit . Our results demonstrate that phototherapy significantly decreased pain ( p < 0.05 ) from 10th treatment to follow-up assessment s and significantly improved ( p < 0.05 ) SF-36 ® physical component summary at posttreatments and follow-up assessment s compared to placebo . We conclude that combination of super-pulsed laser , red and infrared LEDs is effective to decrease pain and improve quality of life in patients with knee pain The purpose of this prospect i ve study was to assess the incidence of flare-ups ( a severe problem requiring an unscheduled visit and treatment ) among patients who received endodontic treatment by the two authors in their respective practice s during a period of one year , and also to examine the correlation with pre-operative and operative variables . The results showed an incidence of 1.58 % for flare-ups from 1012 endodontically treated teeth . Statistical analysis using the chi-square test ( P<0.05 ) indicated that flare-ups were found to be positively correlated with multiple appointments , retreatment cases , periradicular pain prior to treatment , presence of radiolucent lesions , and patients taking analgesic or anti-inflammatory drugs . In contrast , there was no correlation between flare-up , and age , sex , different arch/tooth groups and the status of the pulp Introduction : In this clinical trial , we evaluated the effect of low‐level laser therapy ( LLLT ) on postoperative pain in m and ibular molar teeth with symptomatic apical periodontitis . Methods : Forty‐two patients were included in the study according to the inclusion and exclusion criteria . Root canal treatment was conducted using reciprocating instruments . The patients were r and omly distributed into 3 groups using a Web program as follows : control ( no laser was applied ) , placebo ( mock laser therapy ) , and LLLT . Postoperative pain levels on the 1st , 3rd , 5th , 7th , and 30th day and postoperative percussion pain levels on the visual analog scale were recorded . The chi‐square , 1‐way analysis of variance , and least significant difference post hoc tests were performed to analyze the data ( P = .05 ) . Results : LLLT result ed in lower pain levels than those noted in the control and placebo groups on days 1 and 3 ( P < .05 ) . There were no significant differences among the placebo , LLLT , and control groups in terms of postoperative percussion pain levels ( P < .05 ) . Conclusions : LLLT can be beneficial in reducing postoperative pain in endodontics |
1,359 | 31,661,058 | The study suggested that the intervention is both feasible and acceptable to stakeholders .
A number of modifications were recommended to address some of the issues arising during feasibility testing .
The measurement of outcome measures was successful .
The study has highlighted the feasibility of delivering a creative , tailored , individual approach to intervention for people with dementia following a fall .
Although the intervention required greater investment of time than usual practice , many staff valued the opportunity to work more closely with people with dementia and their carers . | BACKGROUND Fall-related injuries are a significant cause of morbidity and mortality in people with dementia .
There is presently little evidence to guide the management of such injuries , and yet there are potentially substantial benefits to be gained if the outcomes of these injuries could be improved .
This study aim ed to design an appropriate new health-care intervention for people with dementia following a fall and to assess the feasibility of its delivery in the UK NHS .
OBJECTIVES To determine whether or not it is possible to design an intervention to improve outcomes of falls in dementia , to investigate the feasibility and acceptability of the DIFRID ( Developing an Intervention for Fall related Injuries in Dementia ) intervention and to investigate the feasibility of a future r and omised controlled trial and the data collection tools needed to evaluate both the effectiveness and the cost-effectiveness of the DIFRID intervention . | Background Although several face-to-face programs are dedicated to informal caregivers of persons with dementia , they are not always accessible to overburdened or isolated caregivers . Based on a face-to-face intervention program , we adapted and design ed a Web-based fully automated psychoeducational program ( called Diapason ) inspired by a cognitive approach . Objective This study aim ed to evaluate through a pilot unblinded r and omized controlled trial the efficacy and acceptability of a Web-based psychoeducational program for informal caregivers of persons with Alzheimer ’s disease ( PWAD ) based on a mixed methods research design . Methods We recruited and r and omized offline 49 informal caregivers of a PWAD in a day care center in Paris , France . They either received the Web-based intervention and usual care for 3 months ( experimental group , n=25 ) or only usual care ( control group , n=24 ) . Caregivers ’ perceived stress ( PSS-14 , primary outcome ) , self-efficacy , burden , perceived health status , and depression ( secondary outcomes ) were measured during 3 face-to-face on-site visits : at baseline , at the end of the program ( month 3 ) , and after follow-up ( month 6 ) . Additionally , semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis . Results Intention-to-treat analysis did not show significant differences in self-perceived stress between the experimental and control groups ( P=.98 ) . The experimental group significantly improved their knowledge of the illness ( d=.79 , P=.008 ) from baseline to month 3 . Of the 25 participants allocated to the experimental group , 17 ( 71 % ) finished the protocol and entirely viewed at least 10 of 12 online sessions . On average , participants used the website 19.72 times ( SD 12.88 ) and were connected for 262.20 minutes ( SD 270.74 ) . The results of the satisfaction question naire showed that most participants considered the program to be useful ( 95 % , 19/20 ) , clear ( 100 % , 20/20 ) , and comprehensive ( 85 % , 17/20 ) . Significant correlations were found between relationship and caregivers ’ program opinion ( P=.01 ) . Thus , positive opinions were provided by husb and s and sons ( 3/3 ) , whereas qualified opinions were primarily reported by daughters ( 8/11 ) . Female spouses expressed negative ( 2/3 ) or neutral opinions ( 1/3 ) . Caregivers expected more dynamic content and further interaction with staff and peers . Conclusions In this study , quantitative results were inconclusive owing to small sample size . Qualitative results indicated/showed little acceptance of the program and high expectations from caregivers . Caregivers did not rule out their interest in this kind of intervention provided that it met their needs . More dynamic , personalized , and social interventions are desirable . Our recruitment issues pointed out the necessity of in-depth studies about caregivers ’ help-seeking behaviors and readiness factors . Trial Registration Clinical trials.gov NCT01430286 ; http:// clinical trials.gov/ct2/show/NCT01430286 ( Archived by WebCite at http://www.webcitation/6KxHaRspL ) OBJECTIVES To examine whether activity restriction specifically induced by fear of falling ( FF ) contributes to greater risk of disability and decline in physical function . DESIGN Prospect i ve cohort study . SETTING Population -based older cohort . PARTICIPANTS Six hundred seventy-three community-living elderly ( > or = 65 ) participants in the Invecchiare in Chianti Study who reported FF . MEASUREMENTS FF , fear-induced activity restriction , cognition , depressive symptoms , comorbidities , smoking history , and demographic factors were assessed at baseline . Disability in activities of daily living ( ADLs ) and instrumental activities of daily living ( IADLs ) and performance on the Short Performance Physical Battery ( SPPB ) were evaluated at baseline and at the 3-year follow-up . RESULTS One-quarter ( 25.5 % ) of participants did not report any activity restriction , 59.6 % reported moderate activity restriction ( restriction or avoidance of < 3 activities ) , and 14.9 % reported severe activity restriction ( restriction or avoidance of > or = 3 activities ) . The severe restriction group reported significantly higher IADL disability and worse SPPB scores than the no restriction and moderate restriction groups . Severe activity restriction was a significant independent predictor of worsening ADL disability and accelerated decline in lower extremity performance on SPPB over the 3-year follow-up . Severe and moderate activity restriction were independent predictors of worsening IADL disability . Results were consistent even after adjusting for multiple potential confounders . CONCLUSION In an elderly population , activity restriction associated with FF is an independent predictor of decline in physical function . Future intervention studies in geriatric preventive care should directly address risk factors associated with FF and activity restriction to substantiate long-term effects on physical abilities and autonomy of older persons Background Development of longer term stroke rehabilitation services is limited by lack of evidence of effectiveness for specific interventions and service models . We describe the protocol for a multicentre r and omised controlled trial which is evaluating an extended stroke rehabilitation service . The extended service commences when routine ‘ organised stroke care ’ ( stroke unit and early supported discharge ( ESD ) ) ends . Methods / design This study is a multicentre r and omised controlled trial with health economic and process evaluations . It is set within NHS stroke services which provide ESD . Participants are adults who have experienced a new stroke ( and carer if appropriate ) , discharged from hospital under the care of an ESD team . The intervention group receives an extended stroke rehabilitation service provided for 18 months following completion of ESD . The extended rehabilitation service involves regular contact with a senior ESD team member who leads and coordinates further rehabilitation . Contact is usually by telephone . The control group receives usual stroke care post-ESD . Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice . R and omisation is via a central independent web-based service . The primary outcome is extended activities of daily living ( Nottingham Extended Activities of Daily Living Scale ) at 24 months post-r and omisation . Secondary outcomes ( at 12 and 24 months post-r and omisation ) are health status , quality of life , mood and experience of services for patients , and quality of life , experience of services and carer stress for carers . Re source use and adverse events are also collected . Outcomes are undertaken by a blinded assessor . Implementation and delivery of the extended stroke rehabilitation service will also be described . Semi-structured interviews will be conducted with a sub sample of participants and staff to gain insight into perceptions and experiences of rehabilitation services delivered or received . Allowing for 25 % attrition , 510 participants are needed to provide 90 % power to detect a difference in mean Nottingham Extended Activities of Daily Living Scale score of 6 with a 5 % significance level . Discussion The provision of longer term support for stroke survivors is currently limited . The results from this trial will inform future stroke service planning and configuration . Trial registration This trial was registered with IS RCT N ( identifier : IS RCT N45203373 ) on 9 August 2012 BACKGROUND People with cognitive impairment and dementia have a poor outcome after a hip fracture surgery , about 30 - 50 % of all those who sustain a hip fracture have dementia . Therefore the aim was to investigate whether a multidisciplinary postoperative intervention program could reduce postoperative complications and improve functional recovery among people with dementia . METHODS A r and omized controlled trial with subgroup analyses among patients with dementia . Sixty-four patients with femoral neck fracture , aged ≥70 years at Umeå University Hospital , Sweden . The intervention consisted of staff education , individualized care planning and rehabilitation , active prevention , detection and treatment of postoperative complications , especially delirium . The staff worked in teams to apply comprehensive geriatric assessment , management and rehabilitation , including a follow-up at 4 months postoperatively . The control group followed conventional postoperative routines . RESULTS There were fewer postoperative complications in the intervention group such as urinary tract infections , p=0.001 ; nutritional problems , p=0.025 ; postoperative delirium , p=0.002 ; falls , p=0.006 . At 4 months a larger proportion in the intervention group had regained their previous independent indoor walking ability performance , p=0.005 . At 12 months a larger proportion in the intervention group had regained the activities of daily living ( ADL ) performance level they had before the fracture , p=0.027 . CONCLUSION This study demonstrates that patients with dementia who suffer a hip fracture can benefit from multidisciplinary geriatric assessment and rehabilitation and should not be excluded from rehabilitation programs INTRODUCTION Family carers play an important role in providing care for frail older Australians . Carers have increased rates of depression , burden and poor physical health compared with non-carers . Physical activity has been shown to improve outcomes ; however there is limited research investigating outcomes in older carers and less on physical activity for both the carer and care recipient . RESEARCH QUESTION Does a home-based individualised physical activity intervention design ed for both the carer and care recipient improve depression severity in older carers ? PARTICIPANTS AND SETTING 273 community-dwelling carers with depressive symptoms and their care recipients will be recruited for a r and omised controlled trial . Baseline assessment will consist of functional , psychological , and physical measures and information about service use . INTERVENTION AND CONTROL : Participants will be r and omised to receive either a physical activity program ( intervention ) , a social support program ( social control ) , or usual care ( control ) . The intervention and social control groups will have five home visits over six months . MEASUREMENTS All participants will be re-assessed after completion of the program and then six months later to evaluate sustainability of outcomes . The primary outcome measure is the 15-item Geriatric Depression Scale for carers . Secondary outcomes include physical measures for carers and care recipients , carer burden , carer satisfaction , care recipient depression , and cost-effectiveness . All assessors will be blind to group allocation . DISCUSSION This study has the potential to demonstrate that physical activity interventions can be delivered simultaneously to older carers and care recipients to improve mental and physical outcomes Abstract Objective : To evaluate the effect of intensive geriatric rehabilitation on demented patients with hip fracture . Design : Preplanned sub analysis of r and omised intervention study . Settting : Jyväskylä Central Hospital , Finl and . Participants : 243 independently living patients aged 65 years or older admitted to hospital with hip fracture . Intervention : After surgery patients in the intervention group ( n=120 ) were referred to the geriatric ward whereas those in the control group were discharged to local hospitals . Main outcome measures : Length of hospital stay , mortality , and place of residence three months and one year after surgery for hip fracture . Results : The median length of hospital stay of hip fracture patients with moderate dementia ( mini mental state examination score 12 - 17 ) was 47 days in the intervention group ( n=24 ) and 147 days in the control group ( n=12 , P=0.04 ) . The corresponding figures for patients with mild dementia ( score 18 - 23 ) were 29 days in the intervention group ( n=35 ) and 46.5 days in the control group ( n=42 , P=0.002 ) . Three months after the operation , in the intervention group 91 % ( 32 ) of the patients with mild dementia and 63 % ( 15 ) of the patients with moderate dementia were living independently . In the control group , the corresponding figures were 67 % ( 28 ) and 17 % ( 2 ) . There were no significant differences in mortality or in the lengths of hospital stay of severely demented patients and patients with normal mini mental state examination scores . Conclusions : Hip fracture patients with mild or moderate dementia can often return to the community if they are provided with active geriatric rehabilitation Background People with dementia progressively lose abilities and are prone to falling . Exercise- and activity-based interventions hold the prospect of increasing abilities , reducing falls , and slowing decline in cognition . Current falls prevention approaches are poorly suited to people with dementia , however , and are of uncertain effectiveness . We used multiple sources , and a co-production approach , to develop a new intervention , which we will evaluate in a feasibility r and omised controlled trial ( RCT ) , with embedded adherence , process and economic analyses . Methods We will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics , and a family member or carer . We will r and omise participants between a therapy programme with high intensity supervision over 12 months , a therapy programme with moderate intensity supervision over 3 months , and brief falls assessment and advice as a control intervention . The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants . We will measure activities of daily living , falls and a battery of intermediate and distal health status outcomes , including activity , balance , cognition , mood and quality of life . The main aim is to test recruitment and retention , intervention delivery , data collection and other trial processes in advance of a planned definitive RCT . We will also study motivation and adherence , and conduct a process evaluation to help underst and why results occurred using mixed methods , including a qualitative interview study and scales measuring psychological , motivation and communication variables . We will undertake an economic study , including modelling of future impact and cost to end-of-life , and a social return on investment analysis . Discussion In this study , we aim to better underst and the practicalities of both intervention and research delivery , and to generate substantial new knowledge on motivation , adherence and the approach to economic analysis . This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia , which will be evaluated in a definitive r and omised controlled trial . Trial registration Clinical Trials.gov : NCT02874300 ; IS RCT N 10550694 Background Falls are a major cause of morbidity and mortality in dementia , but there have been no prospect i ve studies of risk factors for falling specific to this patient population , and no successful falls intervention/prevention trials . This prospect i ve study aim ed to identify modifiable risk factors for falling in older people with mild to moderate dementia . Methods and Findings 179 participants aged over 65 years were recruited from outpatient clinics in the UK ( 38 Alzheimer 's disease ( AD ) , 32 Vascular dementia ( VAD ) , 30 Dementia with Lewy bodies ( DLB ) , 40 Parkinson 's disease with dementia ( PDD ) , 39 healthy controls ) . A multifactorial assessment of baseline risk factors was performed and fall diaries were completed prospect ively for 12 months . Dementia participants experienced nearly 8 times more incident falls ( 9118/1000 person-years ) than controls ( 1023/1000 person-years ; incidence density ratio : 7.58 , 3.11–18.5 ) . In dementia , significant univariate predictors of sustaining at least one fall included diagnosis of Lewy body disorder ( proportional hazard ratio ( HR ) adjusted for age and sex : 3.33 , 2.11–5.26 ) , and history of falls in the preceding 12 months ( HR : 2.52 , 1.52–4.17 ) . In multivariate analyses , significant potentially modifiable predictors were symptomatic orthostatic hypotension ( HR : 2.13 , 1.19–3.80 ) , autonomic symptom score ( HR per point 0–36 : 1.055 , 1.012–1.099 ) , and Cornell depression score ( HR per point 0–40 : 1.053 , 1.01–1.099 ) . Higher levels of physical activity were protective ( HR per point 0–9 : 0.827 , 0.716–0.956 ) . Conclusions The management of symptomatic orthostatic hypotension , autonomic symptoms and depression , and the encouragement of physical activity may provide the core elements for the most fruitful strategy to reduce falls in people with dementia . R and omised controlled trials to assess such a strategy are a priority Background The rate of falls in community dwelling older people with cognitive impairment ( CI ) is twice that of a cognitively intact population , with almost two thirds of people with CI falling annually . Studies indicate that exercise involving balance and /or a home hazard reduction program are effective in preventing falls in cognitively intact older people . However the potential benefit of these interventions in reducing falls in people with CI has not been established . This r and omised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI . We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers . A health economic analysis examining the cost and potential benefits of the program will also be undertaken . Methods and design Three hundred and sixty people aged 65 years or older living in the community with CI will be recruited to participate in the trial . Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week . Participants will undergo an assessment at baseline with retests at 6 and 12 months . Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities . The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars . Secondary outcome measures will include the risk of falling , quality of life , measures of physical and cognitive function , fear of falling and planned and unplanned use of health services . Carers will be followed up to determine carer burden , coping strategies and quality of life . Discussion The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program . The results will have direct implication s for the design and implementation of interventions for this high-risk group of older people . Trial registration The protocol for this study is registered with the Australian New Zeal and Clinical Trials Registry - AIMS This article is a report on a study of the multidimensional predictors of caregiver burden in caregivers of individuals with dementia using nationally representative data . BACKGROUND Caregiver burden affects the health of both caregivers and their care-recipients . Although previous studies identified various predictors of caregiver burden , these predictors have not been confirmed in nationally representative population . METHODS Data for this secondary analysis was provided by the National Alliance for Caregiving , American Association of Retired Persons . The data were collected through a telephone survey of r and omly selected adults in seven states in 2003 ( weight adjusted n = 302 ) . Descriptive statistics , inter-correlation analysis and a hierarchical multiple regression analysis were performed . RESULTS / FINDINGS Disease-related factors were the most significant predictors , explaining 16 % of caregiver burden ; these were followed by caregiver socio-demographical factors and caregiving-related factors ( F = 21·28 , P < 0·01 ) . Significant individual predictors were impairment of activities of daily living or instrumental activities of daily living , the number of hours of caregiving , use of coping strategies , co-residence , spousal status and caregiver gender ( P < 0·05 ) . CONCLUSION Impaired function in care-recipients predicts caregiver burden , and also interacts with demographical- and caregiving-related factors . Thus , it will be beneficial to both care-recipients and caregivers to target nursing interventions and community services to improve the functional abilities of individuals with dementia Abstract Objective : To determine the effectiveness of multifactorial intervention after a fall in older patients with cognitive impairment and dementia attending the accident and emergency department . Design : R and omised controlled trial . Participants : 274 cognitively impaired older people ( aged 65 or over ) presenting to the accident and emergency department after a fall : 130 were r and omised to assessment and intervention and 144 were r and omised to assessment followed by conventional care ( control group ) . Setting : Two accident and emergency departments , Newcastle upon Tyne . Main outcome measures : Primary outcome was number of participants who fell in year after intervention . Secondary outcomes were number of falls ( corrected for diary returns ) , time to first fall , injury rates , fall related attendances at accident and emergency department , fall related hospital admissions , and mortality . Results : Intention to treat analysis showed no significant difference between intervention and control groups in proportion of patients who fell during 1 year 's follow up ( 74 % ( 96/130 ) and 80 % ( 115/144 ) , relative risk ratio 0.92 , 95 % confidence interval 0.81 to 1.05 ) . No significant differences were found between groups for secondary outcome measures . Conclusions : Multifactorial intervention was not effective in preventing falls in older people with cognitive impairment and dementia presenting to the accident and emergency department after a fall . What is already known on this topic Multifactorial intervention prevents falls in cognitively normal older people living in the community and in those who present to the accident and emergency department after a fall Fall prevention strategies have not been tested by controlled trials in patients with cognitive impairment and dementia who fall What this study adds No benefit was shown from multifactorial assessment and intervention after a fall in patients with cognitive impairment and dementia presenting to the accident and emergency department The intervention was less effective in these patients than in cognitively normal older The Braden Scale for Predicting Pressure Sore Risk was developed to foster early identification of patients at risk for forming pressure sores . The scale is composed of six subscales that reflect sensory perception , skin moisture , activity , mobility , friction and shear , and nutritional status . Content and construct validity were established by expert opinion and empirical testing . Three studies of reliability are reported here , using raters who varied in level of educational preparation and geographic region . Two prospect i ve studies of predictive validity were completed to determine the scale 's sensitivity and specificity . Reliability ranged from r = .83 to r = .94 for nurses ' aides and licensed practical nurses ; when used by registered nurses , the reliability increased to r = .99 . Predictive validity was calculated for each cut-off point of the scale . Using a cutoff point of 16 , sensitivity was 100 % in both studies . Specificity ranged from 64 % to 90 % . This instrument has highly satisfactory reliability when used by RNs , and greater sensitivity and specificity than instruments previously reported OBJECTIVES There is lack of data on the frequency and the causes of hospitalization in mild to moderate Alzheimer 's disease ( AD ) patients . The aims of the present study were to evaluate the frequency and the causes of hospitalization in a large prospect i ve cohort of mild to moderate patients with AD . DESIGN Six hundred and eighty-six AD patients from the French Network on AD ( REAL.FR ) were followed up and assessed every 6 months for 2 years . During follow-up , all events occurring between two visits , in particular hospital admissions or nursing home placements were carefully recorded . RESULTS Annual incidences for hospitalizations were 26.2 % ( 95 % CI , 22.5 to 29.7 ) . After two years , 202 subjects were hospitalized for 296 hospitalizations . 139 subjects were hospitalized once , 40 twice , 13 three times , 4 four times and 2 five times during the two-year follow-up . The duration of hospitalization was 14.3 + /- 23.5 days . For repeated hospitalizations , the time interval between the first and the second hospitalization was 176.4 days ( SD 150.2 ) and the cause of multiple hospitalizations was most different . Fractures and falls not causing fracture were the main reasons for hospital admission ( 20.9 % ) , followed by cardiovascular disorders ( 14.5 % ) and by behavioural disorders ( 11.0 % ) . Admission due to associated diseases or life events was the main reason for hospitalization ( 75.7 % ) . CONCLUSIONS Hospitalization is a frequent event for AD patients even at mild to moderate stage of the disease . In this cohort , the major causes for hospital admission were due to associated diseases or life events and not due to the direct consequences of the disease itself OBJECTIVES Delirium ( or acute confusional state ) affects 35 % to 65 % of patients after hip-fracture repair , and has been independently associated with poor functional recovery . We performed a r and omized trial in an orthopedic surgery service at an academic hospital to determine whether proactive geriatrics consultation can reduce delirium after hip fracture . DESIGN Prospect i ve , r and omized , blinded . SETTING Inpatient academic tertiary medical center . PARTICIPANTS 126 consenting patients 65 and older ( mean age 79 + /- 8 years , 79 % women ) admitted emergently for surgical repair of hip fracture . MEASUREMENTS Detailed assessment through interviews with patients and design ated proxies and review of medical records was performed at enrollment to ascertain prefracture status . Subjects were then r and omized to proactive geriatrics consultation , which began preoperatively or within 24 hours of surgery , or " usual care . " A geriatrician made daily visits for the duration of the hospitalization and made targeted recommendations based on a structured protocol . To ascertain study outcomes , all subjects underwent daily , blinded interviews for the duration of their hospitalization , including the Mini-Mental State Examination ( MMSE ) , the Delirium Symptom Interview ( DSI ) , and the Memorial Delirium Assessment Scale ( MDAS ) . Delirium was diagnosed using the Confusion Assessment Method ( CAM ) algorithm . RESULTS The 62 patients r and omized to geriatrics consultation were not significantly different ( P>.1 ) from the 64 usual-care patients in terms of age , gender , prefracture dementia , comorbidity , type of hip fracture , or type of surgical repair . Sixty-one percent of geriatrics consultation patients were seen preoperatively and all were seen within 24 hours postoperatively . A mean of 10 recommendations were made throughout the duration of the hospitalization , with 77 % adherence by the orthopedics team . Delirium occurred in 20 /62 ( 32 % ) intervention patients , versus 32 / 64 ( 50 % ) usual-care patients ( P = .04 ) , representing a relative risk of 0.64 ( 95 % confidence interval ( CI ) = 0.37 - 0.98 ) for the consultation group . One case of delirium was prevented for every 5.6 patients in the geriatrics consultation group . There was an even greater reduction in cases of severe delirium , occurring in 7/ 60 ( 12 % ) of intervention patients and 18 / 62 ( 29 % ) of usual-care patients , with a relative risk of 0.40 ( 95 % CI = 0.18 - 0.89 ) . Despite this reduction in delirium , length of stay did not significantly differ between intervention and usual-care groups ( median + /- interquartile range = 5 + /- 2 days in both groups ) , likely because protocol s and pathways predetermined length of stay . In subgroup analyses , geriatrics consultation was most effective in reducing delirium in patients without prefracture dementia or activities of daily living ( ADL ) functional impairment . CONCLUSIONS Proactive geriatrics consultation was successfully implemented with good adherence after hip-fracture repair . Geriatrics consultation reduced delirium by over one-third , and reduced severe delirium by over one-half . Our trial provides strong preliminary evidence that proactive geriatrics consultation may play an important role in the acute hospital management of hip-fracture patients OBJECTIVE Skilled nursing facilities ( SNFs ) are major sites of postacute care for patients with dementia . A recent Office of the Inspector General report indicated that outcomes in SNFs are suboptimal because of poor- quality treatment , including the failure to provide needed care . Pain is frequently unrecognized and untreated in patients with dementia . The aim of this exploratory study was to examine the effect daily pain has on delirium and physical function in patients with dementia in SNFs . The association of daily pain with discharge disposition was also examined . DESIGN Secondary analysis of data from an on-going r and omized clinical trial . SETTING Eight SNFs located in central and northeast Pennsylvania . PARTICIPANTS A total of 103 SNF patients with adjudicated dementia and delirium diagnoses and a mean age of 86 ( ±6.8 ) years ; most were women ( 66 % ) and white ( 98 % ) . MEASUREMENTS Measures of pain ( Pain Assessment in Advanced Dementia ) , delirium ( Confusion Assessment Method ) , and physical function ( Barthel Index ) were taken daily for 30 days or until discharge . RESULTS On days when participants experienced greater than their average level of pain , they also experienced more delirium symptoms ( P < .001 ) and lower physical function ( P < .001 ) . Participants with higher levels of average daily pain were more likely to die ( odds ratio [ OR ] 6.306 , 95 % confidence interval [ CI ] 1.914 - 20.771 , P = .003 ) or be placed in a nursing home ( OR 4.77 , 95 % CI 1.7 - 13.2 , P = .003 ) compared with returning to the community at 3-month follow-up . CONCLUSION Greater attention to pain in patients with dementia may be a potential solution to some of the quality problems and high costs of care in SNFs BACKGROUND Falls cause fear , anxiety and loss of confidence , result ing in activity avoidance , social isolation and increasing frailty . The umbrella term for these problems is ' fear of falling ' , seen in up to 85 % of older adults who fall . Evidence of effectiveness of physical and psychological interventions is limited , with no previous studies examining the role of an individually delivered cognitive-behavioural therapy ( CBT ) approach . OBJECTIVES Primary objective To develop and then determine the effectiveness of a new CBT intervention ( CBTi ) delivered by health-care assistants ( HCAs ) plus usual care compared with usual care alone in reducing fear of falling . Secondary objectives To measure the impact of the intervention on falls , injuries , functional abilities , anxiety/depression , quality of life , social participation and loneliness ; investigate the acceptability of the intervention for patients , family members and professionals and factors that promote or inhibit its implementation ; and measure the costs and benefits of the intervention . DESIGN Phase I CBTi development . Phase II Parallel-group patient r and omised controlled trial ( RCT ) of the new CBTi plus usual care compared with usual care alone . SETTING Multidisciplinary falls services . PARTICIPANTS Consecutive community-dwelling older adults , both sexes , aged ≥ 60 years , with excessive or undue fear of falling per Falls Efficacy Scale-International ( FES-I ) score of > 23 . INTERVENTIONS Phase I Development of the CBTi . The CBTi was developed following patient interviews and taught to HCAs to maximise the potential for uptake and generalisability to a UK NHS setting . Phase II RCT . The CBTi was delivered by HCAs weekly for 8 weeks , with a 6-month booster session plus usual care . MAIN OUTCOME MEASURES These were assessed at baseline , 8 weeks , 6 months and 12 months . Primary outcome measure Fear of falling measured by change in FES-I scores at 12 months . Secondary outcome measures These comprised falls , injuries , anxiety/depression [ Hospital Anxiety and Depression Scale ( HADS ) ] , quality of life , social participation , loneliness and measures of physical function . There were process and health-economic evaluations alongside the trial . RESULTS Four hundred and fifteen patients were recruited , with 210 patients r and omised to CBTi group and 205 to the control group . There were significant reductions in mean FES-I [ -4.02 ; 95 % confidence interval ( CI ) -5.95 to -2.1 ] , single-item numerical fear of falling scale ( -1.42 ; 95 % CI -1.87 to 1.07 ) and HADS ( -1 ; 95 % CI -1.6 to -0.3 ) scores at 12 months in the CBTi group compared with the usual care group . There were no differences in the other secondary outcome measures . Most patients found the CBTi acceptable . Factors affecting the delivery of the CBTi as part of routine practice were identified . There was no evidence that the intervention was cost-effective . CONCLUSIONS Our new CBTi delivered by HCAs significantly improved fear of falling and depression scores in older adults who were attending falls services . There was no impact on other measures . FURTHER WORK Further work should focus on a joint CBTi and physical training approach to fear of falling , more rational targeting of CBTi , the possibility of mixed group and individual CBTi , and the cost-effectiveness of provision of CBTi by non-specialists . TRIAL REGISTRATION Current Controlled Trials IS RCT N78396615 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 56 . See the NIHR Journals Library website for further project information Background Loss of arm function is a common and distressing consequence of stroke . We describe the protocol for a pragmatic , multicentre r and omised controlled trial to determine whether robot-assisted training improves upper limb function following stroke . Methods / design Study design : a pragmatic , three-arm , multicentre r and omised controlled trial , economic analysis and process evaluation . Setting : NHS stroke services . Participants : adults with acute or chronic first-ever stroke ( 1 week to 5 years post stroke ) causing moderate to severe upper limb functional limitation . R and omisation groups:1 . Robot-assisted training using the InMotion robotic gym system for 45 min , three times/week for 12 weeks2 . Enhanced upper limb therapy for 45 min , three times/week for 12 weeks3 . Usual NHS care in accordance with local clinical practice R and omisation : individual participant r and omisation stratified by centre , time since stroke , and severity of upper limb impairment . Primary outcome : upper limb function measured by the Action Research Arm Test ( ARAT ) at 3 months post r and omisation . Secondary outcomes : upper limb impairment ( Fugl-Meyer Test ) , activities of daily living ( Barthel ADL Index ) , quality of life ( Stroke Impact Scale , EQ-5D-5L ) , re source use , cost per quality -adjusted life year and adverse events , at 3 and 6 months . Blinding : outcomes are undertaken by blinded assessors . Economic analysis : micro-costing and economic evaluation of interventions compared to usual NHS care . A within-trial analysis , with an economic model will be used to extrapolate longer-term costs and outcomes .Process evaluation : semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided , and factors affecting the implementation of the trial . Sample size : allowing for 10 % attrition , 720 participants provide 80 % power to detect a 15 % difference in successful outcome between each of the treatment pairs . Successful outcome definition : baseline ARAT 0–7 must improve by 3 or more points ; baseline ARAT 8–13 improve by 4 or more points ; baseline ARAT 14–19 improve by 5 or more points ; baseline ARAT 20–39 improve by 6 or more points . Discussion The results from this trial will determine whether robot-assisted training improves upper limb function post stroke . Trial registration IS RCT N , identifier : IS RCT N69371850 . Registered 4 October 2013 Background Delirium is a common complication in patients with hip fractures and is associated with an increased risk of subsequent dementia . The aim of this trial was to evaluate the effect of a pre- and postoperative orthogeriatric service on the prevention of delirium and longer-term cognitive decline . Methods This was a single-center , prospect i ve , r and omized controlled trial in which patients with hip fracture were r and omized to treatment in an acute geriatric ward or st and ard orthopedic ward . Inclusion and r and omization took place in the Emergency Department at Oslo University hospital . The key intervention in the acute geriatric ward was Comprehensive Geriatric Assessment including daily interdisciplinary meetings . Primary outcome was cognitive function four months after surgery measured using a composite outcome incorporating the Clinical Dementia Rating Scale ( CDR ) and the 10 words learning and recalls tasks from the Consortium to Establish a Registry for Alzheimer ’s Disease battery ( CERAD ) . Secondary outcomes were pre- and postoperative delirium , delirium severity and duration , mortality and mobility ( measured by the Short Physical Performance Battery ( SPPB ) ) . Patients were assessed four and twelve months after surgery by evaluators blind to allocation . Results A total of 329 patients were included . There was no significant difference in cognitive function four months after surgery between patients treated in the acute geriatric and the orthopedic wards ( mean 54.7 versus 52.9 , 95 % confidence interval for the difference -5.9 to 9.5 ; P = 0.65 ) . There was also no significant difference in delirium rates ( 49 % versus 53 % , P = 0.51 ) or four month mortality ( 17 % versus 15 % , P = 0.50 ) between the intervention and the control group . In a pre-planned sub-group analysis , participants living in their own home at baseline who were r and omized to orthogeriatric care had better mobility four months after surgery compared with patients r and omized to the orthopedic ward , measured with SPPB ( median 6 versus 4 , 95 % confidence interval for the median difference 0 to 2 ; P = 0.04 ) . Conclusions Pre- and postoperative orthogeriatric care given in an acute geriatric ward was not effective in reducing delirium or long-term cognitive impairment in patients with hip fracture . The intervention had , however , a positive effect on mobility in patients not admitted from nursing homes . Trial registration Clinical Trials.gov NCT01009268 Registered November 5 , Background Hip fracture patients are heterogenous . Certain patient characteristics are associated with poorer prognosis , but less is known about differences in response to treatment among subgroups . The Trondheim Hip Fracture trial found beneficial effects on mobility and function from comprehensive geriatric care ( CGC ) compared to traditional orthopaedic care ( OC ) . The aim of this study was to explore differences in response to CGC among subgroups in this trial . Methods Secondary analysis of the complete data set from Trondheim Hip Fracture Trial , a r and omised controlled trial including 397 home-dwelling older adults ( ≥70 years ) with a hip fracture . Subgroups were age ( over/under 80 years ) , gender , fracture type ( intra-/extracapsular ) , and pre-fracture instrumental ADL ( i-ADL ) ( defined as over/under 45 on the Nottingham Extended ADL scale ) . Dependent variables were mobility ( Short Physical Performance Battery ) , personal ADL ( p-ADL ) ( Barthel Index ) , i-ADL ( Nottingham Extended ADL scale ) , cognition ( Mini-Mental Status Examination ) , four and 12 months after hip fracture . Data were analysed by linear mixed models with interactions ( treatment , time , and subgroup ) , reporting treatment effects being clinical ly and statistically significant within and between subgroups . Results Analyses within subgroups showed beneficial effects of CGC on mobility and i-ADL either at four or twelve months in all subgroups except for males , extra-capsular fractures and patients with impaired pre-fracture i-ADL . Beneficial effect on p- ADL was found in patients < 80 years , intra-capsular fractures and patients with impaired pre-fracture i-ADL . Effects on cognition were found in patients < 80 years and men . The interaction analyses showed that CGC had statistically significant better treatment effect on i-ADL for younger participants at four months ( p = 0.004 ) , on p-ADL both at four ( p = 0.037 ) and twelve months ( p = 0.045 ) and mobility at twelve months ( p = 0.021 ) , for participants with intracapsular as compared to extracapsular fractures , and on i-ADL at twelve months for participants with higher pre-fracture function ( p = 0.012 ) . Conclusion Contrary to our hypothesis that the most vulnerable patients would benefit the most from CGC , we found the intervention effect was most pronounced in younger , female participants with higher pre-fracture i-ADL function . Trial rigistration Clinical Trials.gov registration number : NCT00667914 Objective To determine whether a systematic approach to the treatment of pain can reduce agitation in people with moderate to severe dementia living in nursing homes . Design Cluster r and omised controlled trial . Setting 60 clusters ( single independent nursing home units ) in 18 nursing homes within five municipalities of western Norway . Participants 352 residents with moderate to severe dementia and clinical ly significant behavioural disturbances r and omised to a stepwise protocol for the treatment of pain for eight weeks with additional follow-up four weeks after the end of treatment ( 33 clusters ; n=175 ) or to usual treatment ( control , 27 clusters ; n=177 ) . Intervention Participants in the intervention group received individual daily treatment of pain for eight weeks according to the stepwise protocol , with paracetamol ( acetaminophen ) , morphine , buprenorphine transdermal patch , or pregabaline . The control group received usual treatment and care . Main outcome measures Primary outcome measure was agitation ( scores on Cohen-Mansfield agitation inventory ) . Secondary outcome measures were aggression ( scores on neuropsychiatric inventory-nursing home version ) , pain ( scores on mobilisation-observation-behaviour-intensity-dementia-2 ) , activities of daily living , and cognition ( mini-mental state examination ) . Results Agitation was significantly reduced in the intervention group compared with control group after eight weeks ( repeated measures analysis of covariance adjusting for baseline score , P<0.001 ) : the average reduction in scores for agitation was 17 % ( treatment effect estimate −7.0 , 95 % confidence interval −3.7 to −10.3 ) . Treatment of pain was also significantly beneficial for the overall severity of neuropsychiatric symptoms ( −9.0 , −5.5 to −12.6 ) and pain ( −1.3 , −0.8 to −1.7 ) , but the groups did not differ significantly for activities of daily living or cognition . Conclusion A systematic approach to the management of pain significantly reduced agitation in residents of nursing homes with moderate to severe dementia . Effective management of pain can play an important part in the treatment of agitation and could reduce the number of unnecessary prescriptions for psychotropic drugs in this population . Trial registration Clinical Trials.gov NCT01021696 and Norwegian Medicines Agency EudraCTnr 2008 - 007490 - 20 Background The purpose of this study was to evaluate outcomes for older persons post-hip fracture repair , including those with cognitive impairment ( CI ) , following implementation of a novel model of care – the Patient-Centered Rehabilitation Model including persons with CI ( PCRM-CI ) . The PCRM-CI is an interdisciplinary rehabilitation program that incorporates education for healthcare professionals ( HCPs ) , including nurses , which is focused on geriatric care including management of dementia and delirium , support for HCPs from an Advanced Practice Nurse , and family support and education . Primary outcome measures were mobility gain from admission to discharge and whether or not patients returned home post-discharge . Methods The PCRM-CI intervention was evaluated using a quasi-experimental design , following implementation in two community hospital inpatient rehabilitation units . One hundred forty-nine patients aged 65 and older participated as patients in the usual care ( 76 ) or PCRM-CI intervention ( 73 ) groups . Patient mobility was assessed at admission and discharge by the Functional Independence Measure Motor Subscale ( FIMM ) ; the difference in mobility scores was defined as mobility gain . Patient discharge location was also captured to determine whether or not patients returned home from inpatient rehabilitation . Results No difference in mobility gain was found between the usual care and PCRM-CI groups as measured by the FIMM . Patients in the intervention group were more likely to return home post-discharge than those in the usual care group ( p = 0.02 ) . Conclusions Results of the PCRM-CI evaluation suggest that older adults with CI can successfully be rehabilitated post-hip fracture repair using this novel , interdisciplinary rehabilitation program . Trial registration This trial has been registered with the US National Institutes of Health ( ID : NCT01566136 Purpose . To identify factors contributing to reduced quality of life and increased caregiver strain in an older population referred to a community rehabilitation team and to recommend service delivery models . Methods . Analytical cross-sectional study arising from baseline assessment s from 107 subjects drawn from a r and omised controlled trial of community rehabilitation service delivery models . Setting . A community rehabilitation team based in Brisbane , Queensl and , Australia . Measures . Primary outcome variables include quality of life ( EQ-5D & VAS ) and Carer Strain Index . Predictor variables include participation in functional activities , history of falls , number of medications , number of co-morbidities , depression , environmental hazards , physical function and nutrition . Association between variables assessed using linear regression . Results . Major factors contributing to reduced quality of life were having reduced participation in daily activities , depression , and having poor vision . Having poor nutrition and no longer driving also contributed to poor quality of life . The major factor contributing to increased caregiver strain was reduced participation in daily activities by the older person . Conclusions . Community rehabilitation services working with older population s must adopt models of care that screen for and address a wide range of factors that contribute to poor quality of life and caregiver strain Background People with dementia have a disproportionately high rate of falls and fractures and poorer outcomes , yet there is currently no evidence to guide falls prevention in this population . Methods A r and omised trial design was used to test feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program . The program was tailored to participant ’s individual cognitive levels and implemented as a carer-supported intervention . Feasibility of recruitment , retention and implementation of intervention were recorded through observation and documented in field notes . Adherence , carer burden and use of task simplification strategies were also monitored . Outcome measures , collected at 12 weeks included physiological , fear of falling , cognitive and functional measures . Results Recruitment was achievable but may be more challenging in a multisite trial . Twenty two dyads of persons with mild dementia and their carers were r and omised to intervention or usual care control group . Of 38 dyads referred to the study , there was a high rate of willingness to participate , with 6 ( 16 % ) declining and 10 ( 26 % ) not meeting inclusion criteria . The intervention was well received by participants and carers and adherence to both program components was very good . All participants implemented some home safety recommendations ( range 19 - 80 % ) with half implementing 50 % or more . At the end of 12 weeks , 72 % of the intervention group were exercising . Both the rate of falling and the risk of a fall were lower in the intervention group but these findings were not significant ( RR= 0.50 ( 95 % CI 0.11 - 2.19 ) . There were no differences in physiological outcome measures between the control and intervention groups . However results were influenced by the small study size and incomplete data primarily in the intervention group at follow up . Conclusions The pilot study was feasible and acceptable to people with mild dementia and their carers . The lessons learnt included : recruitment for a larger trial will require multiple approaches ; home safety recommendations should provide a greater emphasis on environmental use compared with behavioural change ; strategies to ensure an adequate dosage of exercise should be further explored . We recommend that intervention delivery incorporate an integrated occupational therapy and physiotherapy approach and that carers be provided with an individualised session to enhance dementia-specific skills in management and communication . A refined intervention should be tested in a r and omised trial with an adequately powered sample size . Trial registration Australia and New Zeal and Clinical Trials Registry IMPORTANCE Few rigorous clinical trials have investigated the effectiveness of exercise on the physical functioning of patients with Alzheimer disease ( AD ) . OBJECTIVES To investigate the effects of intense and long-term exercise on the physical functioning and mobility of home-dwelling patients with AD and to explore its effects on the use and costs of health and social services . DESIGN A r and omized controlled trial . SETTING AND PARTICIPANTS A total of 210 home-dwelling patients with AD living with their spousal caregiver . INTERVENTIONS The 3 trial arms included ( 1 ) group-based exercise ( GE ; 4-hour sessions with approximately 1-hour training ) and ( 2 ) tailored home-based exercise ( HE ; 1-hour training ) , both twice a week for 1 year , and ( 3 ) a control group ( CG ) receiving the usual community care . MAIN OUTCOME MEASURES The Functional Independence Measure ( FIM ) , the Short Physical Performance Battery , and information on the use and costs of social and health care services . RESULTS All groups deteriorated in functioning during the year after r and omization , but deterioration was significantly faster in the CG than in the HE or GE group at 6 ( P = .003 ) and 12 ( P = .015 ) months . The FIM changes at 12 months were -7.1 ( 95 % CI , -3.7 to -10.5 ) , -10.3 ( 95 % CI , -6.7 to -13.9 ) , and -14.4 ( 95 % CI , -10.9 to -18.0 ) in the HE group , GE group , and CG , respectively . The HE and GE groups had significantly fewer falls than the CG during the follow-up year . The total costs of health and social services for the HE patient-caregiver dyads ( in US dollars per dyad per year ) were $ 25,112 ( 95 % CI , $ 17,642 to $ 32,581 ) ( P = .13 for comparison with the CG ) , $ 22,066 in the GE group ( $ 15,931 to $ 28,199 ; P = .03 vs CG ) , and $ 34,121 ( $ 24,559 to $ 43,681 ) in the CG . CONCLUSIONS AND RELEVANCE An intensive and long-term exercise program had beneficial effects on the physical functioning of patients with AD without increasing the total costs of health and social services or causing any significant adverse effects . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12608000037303 The prevention of injury associated with falls in older people is a public health target in many countries around the world . Although there is good evidence that interventions such as multifactorial fall prevention and individually prescribed exercise are effective in reducing falls , the effect on serious injury rates is unclear . Historically , trials have not been adequately powered to detect injury endpoints , and variations in case definition across trials have hindered meta- analysis . It is possible that fall-prevention strategies have limited effect on falls that result in injuries or are ineffective in population s who are at a higher risk of injury . Further research is required to determine whether fall-prevention interventions can reduce serious injuries . Prevention of Falls Network Europe ( ProFaNE ) is a collaborative project to reduce the burden of fall injury in older people through excellence in research and promotion of best practice ( www.profane.eu.org ) . The European Commission funds the network , which links clinicians , members of the public , and research ers worldwide . The aims are to identify major gaps in knowledge in fall injury prevention and to facilitate the collaboration necessary for large-scale clinical research activity , including clinical trials , comparative research , and prospect i ve meta- analysis . Work is being undertaken in a 4-year program . As a first step , the development of a common set of outcome definitions and measures for future trials or meta- analysis was considered OBJECTIVES To evaluate whether an early multidisciplinary geriatric intervention in elderly patients with hip fracture reduced length of stay , morbidity , and mortality and improved functional evolution . DESIGN R and omized , controlled intervention trial . SETTING Orthopedic ward in a university hospital . PARTICIPANTS Three hundred nineteen patients aged 65 and older hospitalized for hip fracture surgery . INTERVENTION Participants were r and omly assigned to a daily multidisciplinary geriatric intervention ( n=155 ) or usual care ( n=164 ) during hospitalization in the acute phase of hip fracture . MEASUREMENTS Primary endpoints were in-hospital length of stay and incidence of death or major medical complications . Secondary endpoints were the rate of recovery of previous activities of daily living and ambulation ability at 3 , 6 , and 12 months . RESULTS Median length of stay was 16 days in the geriatric intervention group and 18 days in the usual care group ( P=.06 ) . Patients assigned to the geriatric intervention showed a lower in-hospital mortality ( 0.6 % vs 5.8 % , P=.03 ) and major medical complications rate ( 45.2 % vs 61.7 % , P=.003 ) . After adjustment for confounding variables , geriatric intervention was associated with a 45 % lower probability of death or major complications ( 95 % confidence interval=7 - 68 % ) . More patients in the geriatric intervention group achieved a partial recovery at 3 months ( 57 % vs 44 % , P=.03 ) , but there were no differences between the groups at 6 and 12 months . CONCLUSION Early multidisciplinary daily geriatric care reduces in-hospital mortality and medical complications in elderly patients with hip fracture , but there is not a significant effect on length of hospital stay or long-term functional recovery OBJECTIVE Authors evaluated the association between use/dosage of risperidone ( RIS ) and falls in a residential-care dementia population . METHODS Authors performed secondary analysis of data from ambulatory patients in a r and omized , double-blind , placebo-controlled , 12-week trial of three RIS dosages ( 0.5 mg/day , 1 mg/day , 2 mg/day ) . Outcomes included number of fallers , rate of falls , and time until the first fall after r and omization . Additional analyses evaluated w and ering as a potential moderating or mediating variable . RESULTS The ambulatory sample included 537 subjects . Of those , 22.3 % on placebo , 18.0 % on RIS 0.5 mg/day , 12.7 % on 1 mg/day , and 27.3 % on 2 mg/day , respectively , fell during the trial . The difference between the RIS 1 mg/day group and placebo was significant , with a significantly lower hazard ratio in the RIS 1-mg/day group than placebo . W and ering was associated with an increased risk of falls . Among 205 patients with the highest levels of w and ering at baseline , RIS 1 mg/day was associated with approximately a 70 % reduction in risk for falls versus placebo condition . However , in those with the lowest levels of w and ering at baseline , RIS 2 mg/day may have increased the risk of falls . CONCLUSIONS Evaluating the benefits versus risks of risperidone in patients with dementia is complex and must consider multiple outcomes as a function of dose . At 1 mg/day , RIS was associated with decreased falls , especially in patients who exhibit w and ering . However , at 2 mg/day , it may increase the risk of falls in ambulatory individuals with low levels of w and ering Health economic evaluations are now more commonly being included in pragmatic r and omized trials . However a variety of methods are being used for the presentation and analysis of the result ing cost data , and in many cases the approaches taken are inappropriate . In order to inform health care policy decisions , analysis needs to focus on arithmetic mean costs , since these will reflect the total cost of treating all patients with the disease . Thus , despite the often highly skewed distribution of cost data , st and ard non-parametric methods or use of normalizing transformations are not appropriate . Although st and ard parametric methods of comparing arithmetic means may be robust to non-normality for some data sets , this is not guaranteed . While the r and omization test can be used to overcome assumptions of normality , its use for comparing means is still restricted by the need for similarly shaped distributions in the two groups . In this paper we show how the non-parametric bootstrap provides a more flexible alternative for comparing arithmetic mean costs between r and omized groups , avoiding the assumptions which limit other methods . Details of several bootstrap methods for hypothesis tests and confidence intervals are described and applied to cost data from two r and omized trials . The preferred bootstrap approaches are the bootstrap-t or variance stabilized bootstrap-t and the bias corrected and accelerated percentile methods . We conclude that such bootstrap techniques can be recommended either as a check on the robustness of st and ard parametric methods , or to provide the primary statistical analysis when making inferences about arithmetic means for moderately sized sample s of highly skewed data such as costs To prove the efficiency of a specialized geriatric ward ( cognitive geriatric unit , CGU ) for patients with a fracture of the proximal femur and additional dementia , we conducted a matched-pair analysis comparing 96 patients with fracture of the proximal femur and additional dementia matched for age , sex , surgical treatment and the degree of cognitive impairment by MMSE score . A total of 48 patients were treated in the CGU , offering extended geriatric assessment , special education of staff , and architecture appropriate for patients with cognitive decline . Target criteria were a gain in the Barthel index and Tinetti score , the length of stay , new admissions to nursing home , the frequency of neuroleptic , antidepressant , and antidementive medication , and the number of specified clinical diagnoses for the dementia syndrome . Length of stay was significantly longer in the CGU . The increase of the Tinetti score was significantly higher in the patients in the CGU , regardless of the length of stay ( analysis of covariance : treatment ( CGU/non-CGU ) : F(1/93 ) = 9.421 , p = 0.003 ; covariate ( length of stay ) : F(1/93 ) = 3.452 , p = 0.066 , η2 = 3.6 % ) . In the intervention group , the number of definite diagnoses concerning the dementia syndrome was also higher . Comparison of drug treatment and the percentage of new admission to a nursing home did not differ between groups . Treatment in a specialized , “ cognitive geriatric unit ” seems to result in better mobility of demented patients with proximal fractures of the femur . ZusammenfassungUm die Effektivität einer Spezialstation ( „ cognitive geriatric unit “ , CGU ) für kognitiv eingeschränkte Patienten mit zusätzlichen Akuterkrankungen zu überprüfen , untersuchten wir in einer Matched-Pair-Analyse 96 Patienten mit proximaler Femurfraktur und zusätzlicher Demenzerkrankung . Insgesamt 48 Patienten wurden in einer Spezialstation für „ kognitive Geriatrie “ beh and elt , die and eren 48 Patienten waren vor Gründung der Station in der gleichen Krankenhausabteilung beh and elt worden . Die Patienten waren nach Alter , Geschlecht , Art der chirurgischen Vorbeh and lung und dem Ergebnis des Mini-Mental-Status paarweise zusammengefasst . Die Beh and lung in der Spezialstation umfasste u. a. ein erweitertes geriatrisches Assessment , spezielle Ausbildung der Mitarbeiter und architektonische Ausrichtung für Patienten mit kognitiven Einschränkungen . Untersucht wurden der Zuwachs i m Barthel-Index und Tinetti-Mobilitätsscore , die Aufenthaltsdauer , Ziel der Entlassung , die Medikation und die Spezifität der Demenzdiagnosen . Die Aufenthaltsdauer auf der Spezialstation für kognitive Geriatrie war signifikant länger . Der Zuwachs i m Tinetti-Score war in der Spezialstation signifikant größer als bei konventioneller Beh and lung , unabhängig von der längeren Aufenthaltsdauer [ Kovarianzanalyse : Beh and lung ( CGU/Nicht-CGU ) : F(1/93)=9,421 , p = 0,003 ; Kovariate ( Aufenthaltsdauer ) : F(1/93)=3,452 , p = 0,066 , η2 = 3,6 % ] . Auch die Anzahl der spezifizierten Demenzdiagnosen war in der Spezialabteilung größer . Die Beh and lung von Patienten mit proximaler Femurfraktur und Demenz in einer Spezialeinheit für kognitiv eingeschränkte Patienten scheint mit einer zusätzlich verbesserten Mobilität einherzugehen A mental health enterprise may be described by either ( a ) rather general philosophical total mental health goals , or ( b ) highly diverse and individualized patient-therapist goals . Goals a. have not provided a workable framework for program evaluation . This paper proposes that evaluation be done in the framework of goals b. by setting up , before treatment , a measurable scale for each patient-therapist goal , and specifying , for each patient , a transformation of his overall goal attainment into a st and ardized T-score . This method , together with r and om assignment of patients to treatment modes , was devised to permit comparison of treatment modes within a program , but it also provides a good basis for a judgmental evaluation of the total program OBJECTIVES To compare outcomes ( physical functions and discharge destinations ) of cognitively impaired and intact older hip fracture patients , and to identify cognitive skills related to functional gains . DESIGN Prospect i ve longitudinal study of hip fracture patients treated on an acute inpatient rehabilitation service , with evaluation of functional performance and living status determined at admission and discharge . SETTING A specialized inpatient geriatric rehabilitation program at Wesley Woods Geriatric Hospital , which is affiliated with Emory University School of Medicine . SUBJECTS Fifty-eight hip fracture patients , 35 with and 23 without cognitive impairment . MEASUREMENTS Cognitive functioning measured by the Mattis Dementia Rating Scale ( MDRS ) ; functional outcome assessed by the Functional Independence Measure ( FIM ) ; comparison of pre-fracture with discharge living environments . MAIN RESULTS Both cognitively impaired and intact hip fracture patients exhibited similar overall FIM motor improvements as well as functional gains in specific FIM areas measuring self-care , sphincter control , and locomotion ( e.g. , walking ) . Cognitively intact patients , however , displayed significantly greater gains in mobility ( e.g. , transfers ) at discharge . Cognitively impaired patients who lived in the community were as likely as intact patients to return to the community . Patients who entered the program at a modified dependence level ( FIM 3 - 5 ) and achieved motor independence at discharge ( FIM 6 - 7 ) had higher MDRS initiation/ perseveration and memory scores . CONCLUSIONS Hip fracture patients with cognitive impairments can achieve positive outcomes as defined by functional improvement and discharge destination . Intensive post-fracture rehabilitation in the early phase of recovery may promote functional independence and a return to the community for older patients at risk for nursing home placement . Future research should examine the long-term maintenance of these improvements and explore how rehabilitation interventions can be altered to enhance outcome BACKGROUND Exercise may lead to improvements on functional ability , physical function , and neuropsychiatric symptoms ( particularly depression ) in people with dementia ( PWD ) . However , high- quality r and omised controlled trial ( RCT ) , controlling for the socialisation aspect of group-based exercise interventions , and design ed to delay the declines on the functional ability of PWD in the nursing home ( NH ) setting is almost inexistent . This article describes the protocol of the LEDEN study , an exercise RCT for PWD living in NHs . METHODS / DESIGN LEDEN is a cluster-r and omised controlled pilot trial composed of two research arms : exercise training ( experimental group ) and social/recreational activity ( control group ) . Both interventions will be provided twice a week , for 60 min , during the 6-month intervention . The total duration of the study is 12 months , being six months of intervention plus six months of observational follow-up . Eight French NHs volunteered to participate in LEDEN ; they have been r and omised to either exercise intervention or social/recreational intervention in a 1:1 ratio . RESULTS The primary objective is to investigate the effects of exercise , compared to a social/recreational intervention , on the ability of PWD living in NHs to perform activities of daily living ( ADL ) . Secondary objectives are related with the cost-effectiveness of the interventions , and the effects of the interventions on patients ' physical function , neuropsychiatric symptoms , pain , nutritional status , and the incidence of falls and fractures . DISCUSSION LEDEN will provide the preliminary evidence needed to inform the development of larger and more complex interventions using exercise or non-exercise social interventions UNLABELLED Al-Ani AN , Flodin L , Söderqvist A , Ackermann P , Samnegård E , Dalén N , Sääf M , Cederholm T , Hedström M. Does rehabilitation matter in patients with femoral neck fracture and cognitive impairment ? A prospect i ve study of 246 patients . OBJECTIVE To identify factors associated with preserved walking ability and Katz activities of daily living ( ADLs ) index at 4-month and 12-month follow-up in cognitively impaired patients with femoral neck fracture . DESIGN Population -based cohort study . SETTING A multicenter study of the Stockholm Hip Fracture Group including 4 university hospitals . PARTICIPANTS Consecutive patients ( N=246 ) with femoral neck fracture , older than 65 years ( mean , 84y ; 72 % women ) with cognitive impairment ( known dementia or low [ 0 - 2 points ] score ) in Short Portable Mental Status Question naire [ 0 - 10 points ] ) and able to walk before the fracture . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURE Walking ability and ADLs index at 4-month and 12-month follow-up . RESULTS Significant predictors of preserved walking ability at 12-month follow-up were discharge to rehabilitation unit ( odds ratio [OR]=2.83 ; confidence interval [ CI ] , 1.1 - 7.26 ; P=.03 ) and walking ability before the fracture ( OR=8.98 ; CI , 3.52 - 22.93 ; P<.001 ) , while type of surgery was not ( P=.197 ) . Analyses were adjusted for age , sex , American Society of Anesthesiologists score , fracture type , and surgical method . Corresponding predictors of preserved Katz ADLs index at 12-month follow-up , after adjustment for age and sex , were discharge to rehabilitation unit ( OR=5.33 ; CI , 1.44 - 19.65 ; P=.012 ) and ADLs index before fracture ( OR=2.51 ; CI , 1.8 - 3.5 ; P<.001 ) , while type of surgery was not ( P=.376 ) . CONCLUSIONS Discharge to rehabilitation unit , a factor we can influence , was associated with preserved walking ability and ADLs index in cognitively impaired patients with hip fracture The present study was design ed to identify prospect ively the individual chronic characteristics associated with falling among elderly persons and to test the hypothesis that risk of falling increases as the number of chronic disabilities increases . Seventy-nine consecutive admissions to three intermediate care facilities were evaluated . Twenty-five of the subjects became recurrent fallers . The nine risk factors included in the fall risk index were mobility score , morale score , mental status score , distant vision , hearing , postural blood pressure , results of back examination , postadmission medications , and admission activities of daily living score . A subject 's fall risk score was the number of index factors present . The proportions of recurrent fallers increased from 0 percent ( 0 of 30 ) in those with 0 to three risk factors , to 31 percent ( 11 of 35 ) in those with four to six factors , to 100 percent ( 14 of 14 ) in those with seven or more factors . Falling , at least among some elderly persons , appears to result from the accumulated effect of multiple specific disabilities . Some of these disabilities may be remediable . The mobility test , the best single predictor of recurrent falling , may be useful clinical ly because it is simple , recreates fall situations , and provides a dynamic , integrated assessment of mobility OBJECTIVES To determine whether community-based primary care physician (PCP)-nurse practitioner ( NP ) comanagement implementing the Assessing Care of Vulnerable Elders (ACOVE)-2 model : ( case finding , delegation of data collection , structured visit notes , physician and patient education , and linkage to community re sources ) can improve the quality of care for geriatric conditions . DESIGN Case study . SETTING Two community-based primary care practice s. PARTICIPANTS Patients aged 75 and older who screened positive for at least one condition : falls , urinary incontinence ( UI ) , dementia , and depression . INTERVENTION The ACOVE-2 model augmented by NP comanagement of conditions . MEASUREMENTS Quality of care according to medical record review using ACOVE-3 quality indicators ( QIs ) . Individuals receiving comanagement were compared with those who received PCP care alone in the same practice s. RESULTS Of 1,084 screened individuals , 658 ( 61 % ) screened positive for more than one condition ; 485 of these were r and omly selected for chart review and triggered a mean of seven QIs . A NP saw 49 % for comanagement . Overall , individuals received 57 % of recommended care . Quality scores for all conditions ( falls , 80 % vs 34 % ; UI , 66 % vs 19 % ; dementia , 59 % vs 38 % ) except depression ( 63 % vs 60 % ) were higher for individuals who saw a NP . In analyses adjusted for sex and age of patient , number of conditions , site , and a NP estimate of medical management style , NP comanagement remained significantly associated with receiving recommended care ( P < .001 ) , as did NP estimate of medical management style ( P = .02 ) . CONCLUSION NP comanagement is associated with better quality of care for geriatric conditions in community-based primary care than usual care using the ACOVE-2 model BACKGROUND to develop a physical training programme to improve balance in dependent , demented , people with a history of falling , and so decrease falls and increase autonomy . METHODS the study was undertaken on 20 demented elderly people with a history of falling with an average age of 81.4+/-4.7 years and an average mini mental state score of 16.3+/-6.5 . They had all passed ' get up and go ' , ' chair sit and reach ' , walking speed and static balance tests . They were assigned to a control group or a training group ; the latter were trained with two sessions a week for 16 weeks . RESULTS walking , mobility , flexibility and static balance were significantly improved in the training group ( P<0.05 ) , but not in the controls . The trained subjects did not suffer a relapse , while the controls did during the training period . CONCLUSION the balance of frail , demented , elderly patients with a history of falling can be improved by training BACKGROUND Depression is common in nursing home ( NH ) patients with dementia , and often clustered with anxiety and other mood symptoms . An association between pain and depressive symptoms has been reported , but the impact of pain management on depression and other mood symptoms has not been investigated . OBJECTIVE Secondary analyses of a cluster r and omized clinical trial examine the response of dementia-related mood symptoms to a Stepwise Protocol of Treating Pain . METHOD Three-hundred fifty-two patients with moderate and severe dementia and significant behavioural disturbances , related to 60 clusters ( i.e. clusters defined as single independent NH units ) in 18 NHs of Western Norway , were included . All patients in the intervention group received individual daily pain treatment with paracetamol , extended release morphine , buprenorphine transdermal patch or pregabaline for 8 weeks , with additional follow-up assessment 4 weeks after completion of the intervention . Clusters r and omized to control received usual treatment . A mood cluster consisting of depression , anxiety , sleep disorders , apathy and appetite items from the Neuropsychiatric Inventory-Nursing Home ( NPI-NH ) was the primary outcome . RESULTS Analysed by Mann-Whitney U-tests , Stepwise Protocol of Treating Pain conferred significant benefit in treatment of the NPI-NH mood cluster ( F = 13.4 , df = 1;299 , p < 0.001 ) and depression ( F = 2.0 , df = 1;301 , p = 0.025 ) . Further analyses highlighted improvements in apathy ( F = 5.3 , df = 1;300 , p = 0.017 ) , night-time behaviours ( F = 3.1 , df = 1;301 , p = 0.050 ) , and appetite items ( F = 11.6 , df = 1;301 , p = 0.005 ) , but not irritability ( p = 0.092 ) and anxiety ( p = 0.125 ) . CONCLUSION Mood symptoms including depression significantly improved with pain treatment , emphasizing the importance of more rigorous treatment of pain in agitated people with dementia . Findings have potentially immediate clinical relevance Background People with dementia ( PWD ) experience ten times as many incident falls as people without dementia . Little is known about how best to deliver services to people with dementia following a fall . We used an integrated , mixed- methods approach to develop a new intervention which combines theory generated via a realist synthesis and data on current provision and pathways , gathered through a prospect i ve observational study as well as qualitative interviews , focus groups and ethnographic observation . This intervention is to be tested in a feasibility study in the UK National Health Service . Methods People living with dementia in one of three geographical areas will be eligible for the study if they experience a fall requiring healthcare attention and have an informal carer . Potential participants will be identified by community services ( primary care , paramedics , telecare ) , secondary care ( ED , facilitated discharge services , rehabilitation outreach teams ) and research case registers . Participants will receive a complex multidisciplinary intervention focused on their goals and interests for up to 12 weeks . The intervention will be delivered by occupational therapists , physiotherapists and rehabilitation support workers . Feasibility outcomes will include recruitment and retention , suitability and acceptability of outcome measures and acceptability , feasibility and fidelity of intervention components . PWD outcome measures will include number of falls , Montreal Cognitive Assessment ( MOCA ) , European Quality of Life Instrument ( EQ-5D-5L ) , Quality of Life – Alzheimer ’s Disease Scale ( QOL-AD ) , Modified Falls Efficacy Scale ( MFES ) and Goal Attainment Scaling ( GAS ) . PWD outcome measures completed by an informal carer will include Disability Assessment for Dementia ( DAD ) , EQ-5D-5L Proxy , QoL-AD Proxy and a Health Utilisation Question naire ( HUQ ) . The carer outcome measure will be the Zarit Burden Interview ( ZBI ) . An embedded process evaluation will explore barriers and facilitators to recruitment and intervention delivery . Discussion The study results will inform whether and how a larger multicentre RCT should be undertaken . A full RCT would have the potential to show how outcomes can be improved for people with dementia who have fallen . Ethics and disseminationThe National Research Ethics Service Committee Newcastle and North Tyneside 2 approved the feasibility study .Trial registration International St and ard R and omised Controlled Trial Registry . Registration number : IS RCT N41760734 . Date of registration : 16/11/2015 OBJECTIVE --To compare postoperative collaborative care between orthopaedic surgeons and physicians in geriatric medicine with routine orthopaedic care in elderly women with proximal femoral fracture . DESIGN --Exclusion of patients dying before fit enough to enter trial , those with pathological fractures , those likely to be discharged within seven days of entering the trial , and those remaining unfit for transfer to a peripheral hospital . Remainder allocated to two groups : treatment group and control group . SETTING --District hospital acute admission ward and rehabilitation ward . PATIENTS --144 sequentially admitted elderly women with proximal fracture of the femur ; 36 excluded on above criteria and remainder entered into trial . INTERVENTION -- Both treatment and control groups ( n = 54 in each ) received physiotherapy and other services . The treatment group also received thrice weekly supervision by a geriatrician . END POINTS -- Physical independence , residence after discharge , and length of hospital stay . MEASUREMENTS AND MAIN RESULTS --At discharge significantly more patients in treatment group were independent in terms of activities of daily living than controls ( 41 v 25 ) and their median stay was 24 days ( range 8 - 197 ) compared with 41 ( 9 - 365 ) ( 95 % confidence intervals for difference 2 to 25 ) . Significantly fewer treatment patients were discharged to institutional care ( 10 % v 32 % ; 95 % confidence interval for difference 6 % to 37 % ) and more to their own homes ( 63 % v 38 % ; 95 % confidence interval for difference 6 % to 44 % ) . These beneficial effects were consistent across a range of ages and mental state . CONCLUSIONS --Both hospital and patient benefited when postoperative rehabilitation was provided in a setting specialising in such care for elderly patients with trauma |
1,360 | 24,798,807 | The time point of urine collection did not affect the diagnostic performance of either test .
AND RELEVANCE The UAC and the ACR yielded high sensitivity and specificity for the detection of microalbuminuria . | IMPORTANCE A r and om urine sample measuring the albumin concentration ( UAC ) without simultaneously measuring the urinary creatinine is less expensive than measuring the ratio of albumin to creatinine ( ACR ) , but comparisons of their diagnostic performance for microalbuminuria screening among patients with diabetes mellitus ( DM ) have not been undertaken in previous meta-analyses .
OBJECTIVE To compare the diagnostic performance of the UAC vs the ACR in r and om urine sample s for microalbuminuria screening among patients with DM . | The predictive value of r and om urine sample during outpatient visit to predict persistent microalbuminuria was studied in 76 Type 1 , insulin-dependent diabetic subjects , 61 Type 2 , non-insulin-dependent diabetic subjects , and 72 Type 2 , insulin-treated diabetic subjects . Seventy-six patients attended outpatient clinic during morning , and 133 during afternoon . Microalbuminuria was suspected if Urinary Albumin Excretion ( UAE ) exceeded 20 mg/l . All patients were hospitalized within 6 months following outpatient visit , and persistent microalbuminuria was assessed then if UAE was between 30 and 300 mg/24 h on 2 - 3 occasions in 3 urines sample s. Of these 209 subjects eighty-three were also screened with Microbumintest ( Ames-Bayer ) , a semi-quantitative method . Among the 209 subjects , 71 were positive both for microalbuminuria during outpatient visit and a persistent microalbuminuria during hospitalization : sensitivity 91.0 % , specificity 83.2 % , concordance 86.1 % , and positive predictive value 76.3 % ( chi-squared test : 191 ; p less than 10(-4 ) ) . Data were not different for subjects examined on morning , or on afternoon . Among the 83 subjects also screened with Microbumintest , 22 displayed both a positive reaction and a persistent microalbuminuria : sensitivity 76 % , specificity 81 % , concordance 80 % , and positive predictive value 69 % ( chi-squared test : 126 ; p less than 10(-4 ) ) . Both types of screening appeared equally effective during outpatient visit . Hence , a persistent microalbuminuria can be predicted during an outpatient visit in a diabetic clinic BACKGROUND The first step in the diagnosis of diabetic nephropathy is to measure albumin in a spot urine sample . The aim of this study was to assess the accuracy of urinary albumin concentration ( UAC ) , urinary albumin-to-creatinine ratio ( UACR ) , and the Micral-Test II in a r and om urine specimen ( RUS ) for microalbuminuria screening in diabetes mellitus . METHODS Two hundred and seventy-eight patients collected 24 h timed urine specimens followed by RUS . Albumin ( immunoturbidimetry ) and creatinine were measured in protein-negative ( Combur-Test ) urine sample s. Sample s were classified as normoalbuminuric [ 24 h urinary albumin excretion rate ( UAER ) < 20 microg/min ; n = 189 ] and microalbuminuric ( UAER = 20 - 199 microg/min ; n = 89 ) . Micral-Test II readings were performed in 130 RUS . Receiver operating characteristics ( ROC ) curves were constructed using UAER as the reference st and ard . RESULTS The areas under the ROC curves were similar for UAC ( 0.934+/-0.032 ) and UACR ( 0.920+/-0.035 ; P = 0.626 ) , but the Micral-Test II had lower accuracy to diagnose microalbuminuria ( area = 0.846+/-0.047 ) than UAC ( P = 0.014 ) . The first cutoff point with 100 % sensitivity for UAC was 14.4 mg/l ( specificity = 77.2 % ) , and 15.7 mg/g for UACR ( specificity = 73.0 % ) . Concerning the Micral-Test II , sensitivity and specificity for the 20 mg/l cutoff point were 90.0 and 46.0 % , respectively . The agreement between UAER and the Micral-Test II for microalbuminuria diagnosis was 55.8 % ( kappa = 0.22 ; P < 0.001 ) . The cost of diagnosing microalbuminuria was 1.74 dollars(UAC ) , 2.00 dollars ( UACR ) and 4.09 dollars ( Micral-Test II ) per patient . CONCLUSIONS Measurement of UAC in a RUS was the best choice for the diagnosis screening of microalbuminuria in diabetic patients , considering cost and accuracy BACKGROUND Accurate measurement of proteinuria is important in the diagnosis and management of chronic kidney disease ( CKD ) . The reference st and ard test , 24-hour urinary protein excretion , is inconvenient and vulnerable to collection errors . Spot urine protein-creatinine ratio ( PCR ) is a convenient alternative and is in widespread use . However , day-to-day variability in PCR measurements has not been evaluated . STUDY DESIGN Prospect i ve cohort study of day-to-day variability in spot urine PCR measurement . SETTING & PARTICIPANTS Clinical ly stable out patients with CKD ( n = 145 ) attending a university hospital CKD clinic in Australia between July 2007 and April 2010 . INDEX TEST Spot urine PCR . OUTCOMES Spot PCR variability was assessed and repeatability limits were determined using fractional polynomials . MEASUREMENTS Spot PCRs were measured from urine sample s collected at 9:00 am on consecutive days and 24-hour urinary protein excretion was collected concurrently . RESULTS Paired results were analyzed from 145 patients : median age , 56 years ; 59 % men ; and median 24-hour urinary protein excretion , 0.7 ( range , 0.06 - 35.7 ) g/d . Day-to-day variability was substantial and increased in absolute terms , but decreased in relative terms with increasing baseline PCR . For patients with a low baseline PCR ( 20 mg/mmol [ 177 mg/g ] ) , a change greater than ±160 % ( repeatability limits , 0 - 52 mg/mmol [ 0 - 460 mg/g ] ) is required to indicate a real change in proteinuria status with 95 % certainty , whereas for those with a high baseline PCR ( 200 mg/mmol [ 1,768 mg/g ] ) , a change of ±50 % ( decrease to < 100 mg/mmol [ < 884 mg/g ] or increase to > 300 mg/mmol [ > 2,652 mg/g ] ) represents significant change . LIMITATIONS These study results need to be replicated in other ethnic groups . CONCLUSIONS Changes in PCR observed in patients with CKD , ranging from complete resolution to doubling of PCR values , could be due to inherent biological variation and may not indicate a change in disease status . This should be borne in mind when using PCR in the diagnosis and management of CKD The effectiveness of four urine screening tests-microalbumin ( MAlb ) , total protein ( TProt ) , total protein/creatinine ratio ( TProt/Cr R ) , and dipstick ( DPalb ) test for albumin-were evaluated for the detection of MAlb in r and om urine specimens . The following criteria were used to assess the effectiveness of each urine screening test : 100 % specificity ( no false positive results ) ; cost effectiveness ; rapidity and ease of performing the screening test ; and increased laboratory efficiency . A " gold st and ard " for presence of MAlb in r and om urine sample s was defined as a microalbumin/creatinine ratio ( MAlb/Cr R ) of > or = 30 mg/g . The least costly urine screening test was the DPalb , which , if assigned a value of 1.0 , allowed a cost ranking order for the screening tests-DPalb ( 1.0 ) < urine TProt ( 1.03 ) < urine TProt/Cr R ( 2.1 ) < urine MAlb ( 7.0 ) . Two hundred urine sample s from diabetic in patients and out patients were tested . Only two screening tests -- MAlb and DPalb -- achieved 100 % specificity without increasing laboratory costs ( small net savings ) , whereas the other two screening tests -- TProt and TProt/Cr R-only achieved 100 % specificity with increased laboratory costs . Theoretical prevalence rate analysis showed that urine MAlb screening would be effective at all prevalence rates for overt nephropathy . TProt and DPalb urine screening testing would be most effective in population s with prevalence rates of > or = 15 % for overt nephropathy . The TProt/Cr R ratio would only be effective in population s with prevalence rates of > or = 30 % . Of the four urine screening tests , only DPalb would significantly streamline the process of measuring urine MAlb . The dipstick test is inexpensive , easy and rapid to perform , does not delay measuring the ratio , since there is no wait for the screening test result , and can be used by referring laboratories to screen urine specimens before they are su bmi tted to a central laboratory , thereby reducing laboratory workload OBJECTIVE To evaluate single- sample urine collection s to determine their ability to screen patients for the presence of microalbuminuria . Microalbuminuria in patients with type I diabetes predicts the development of diabetic renal disease . RESEARCH DESIGN AND METHODS Cross-sectional analysis of single- sample urine collection techniques ( first morning void , r and om upright void ) and methods of albumin analysis ( RIA , reagent tablet ) were compared with conventional 24-h urine collection s ( RIA ) . The study included 94 patients ( 45 males , 49 females ; mean serum creatinine 88 μM ) with type I diabetes , selected from a screened population of 301 patients from the University Hospital Subspecialty Clinics . RESULTS A 24-hour urine collection RIA analysis for albumin revealed 36 normal patients ( < 30 mg ) , 27 with microalbuminuria ( 30–300 mg ) , and 31 with albuminuria ( > 300 mg ) . R and om upright urine sample s were more sensitive ( RIA 89 % , tablets 78 % ) for the detection of microalbuminuria than first morning void specimens ( RIA 70 % , tablets 60 % ) . Specificity was > 80 % with both r and om and first morning voids . CONCLUSIONS Screening for microalbuminuria can be performed in the clinic by r and om upright single- sample urine collection s. When reagent tablets were used , these results are available immediately . Patients who screen positive should be confirmed by 24-h or other timed urine collection OBJECTIVE To assess the performance of measurements of urinary albumin concentration ( UAC ) and urinary albumin : creatinine ratio ( UACR ) in a diurnal r and om urine specimen ( RUS ) for the screening of diabetic nephropathy . RESEARCH DESIGN AND METHODS A total of 95 ambulatory NIDDM patients ( 49 women , ages 40–75 years ) collected 123 RUSs during the morning after completing a timed 24-h urine collection . Albumin was measured by immunoturbidimetry . According to timed urinary albumin excretion rate ( UAER ) measured in the 24-h collection ( criterion st and ard ) , sample s were classified as normoalbuminuric ( UAER < 20 μg/min ; n = 54 ) , microalbuminuric ( UAER 20–200 μg/min ; n = 44 ) , and macroalbuminuric ( UAER > 200 μg/min ; n = 25 ) . The receiver operating characteristics ( ROC ) curve approach was used . The ROC curves of UAC and UACR in RUS for screening of microalbuminuria ( normo- and microalbuminuric sample s ; n = 98 ) and macroalbuminuria ( micro- and macroalbuminuric sample s ; n = 69 ) were plotted . RESULTS Spearman 's coefficients of correlation of 24-h UAER vs. UAC and UACR were 0.91 and 0.92 , respectively ( P < 0.001 ) . The calculated areas ( ± SE ) under the ROC curves to screen microalbuminuria for UAC ( 0.9766 ± 0.015 ) and UACR ( 0.9689 ± 0.014 ) were similar ( P > 0.05 ) as were the corresponding areas for macroalbuminuria ( 0.9868 ± 0.0094 and 0.9614 ± 0.0241 , respectively ; P > 0.05 ) . The first point with 100 % sensitivity and the point of intersection with a 100%-to-100 % diagonal for microalbuminuria were as follows : 16.9 and 33.6 mg/l for UAC and 15.0 and 26.8 mg/g for UACR ; for macroalbuminuria 174.0 and 296.2 mg/l for UAC and 116.0 and 334.3 mg/g for UACR , respectively . CONCLUSIONS Albumin measurements ( UAC and UACR ) in an RUS presented almost perfect accuracy for the screening of micro- and macroalbuminuria and UAC measured in an RUS is simpler and less expensive than UACR and UAER . It is suggested as a valid test for use in screening for diabetic nephropathy To assess the validity of urine albumin concentration ( UAC ) and the urine albumin : creatine ratio ( UACR ) in a r and om urine specimen ( RUS ) for screening diabetic nephropathy in Korea , a total of 105 ambulatory diabetes mellitus patients ( male : female , 52:53 ) , ages 40 - 75 years ( median 59 years ) collected 105 RUSs after completing a timed 24 hour urine collection . Albumin was measured by immunonephelometry . According to the timed urinary albumin excretion rate ( UAER ) measured in the 24 hour collection ( criterion st and ard ) , sample s were classified normoalbuminuric ( UAER < 20 micrograms/min ; n = 50 ) , microalbuminuric ( UAER 20 - 200 micrograms/min ; n = 30 ) , and macroalbuminuric ( UAER > 200 micrograms/min ; n = 25 ) . The receiver operating characteristics ( ROC ) curve of UAC and UACR in a RUS for screening of microalbuminuria ( normo- and microalbuminuric sample s ; n = 80 ) and macroalbuminuria ( micro- and macroalbuminuric sample s ; n = 55 ) were plotted . Pearson 's coefficients of correlation of 24 hour UAER vs. UAC and UACR were 0.81 and 0.75 , respectively ( P < 0.001 ) . The point of intersection with a 100%-to-100 % diagonal for microalbuminuria were as follows : 31.0 mg/l for UAC and 32.5 mg/g for UACR ; for macroalbuminuria 181 mg/l for UAC and 287.3 mg/g for UACR . The sensitivity and specificity of the cut-off points for microalbuminuria were 77 % and 82 % for UAC and 77 % and 92 % for UACR . The sensitivity and specificity of the cut-off points for macroalbuminuria were 84 % and 90 % for UAC and 88 % and 90 % for UACR . In present study , no difference was observed when comparing the performance of UAC and UACR based on a statistical comparison by McNemar test . The repeated measurements of UAC and UACR in the same individual were statistically similar and were correlated with each other . Based on these results , albumin measurements ( UAC and UACR ) in a RUS were considered as a valid test for screening diabetic nephropathy BACKGROUND AND OBJECTIVE Publication bias and other sample size effects are issues for meta-analyses of test accuracy , as for r and omized trials . We investigate limitations of st and ard funnel plots and tests when applied to meta-analyses of test accuracy and look for improved methods . METHODS Type I and type II error rates for existing and alternative tests of sample size effects were estimated and compared in simulated meta-analyses of test accuracy . RESULTS Type I error rates for the Begg , Egger , and Macaskill tests are inflated for typical diagnostic odds ratios ( DOR ) , when disease prevalence differs from 50 % and when thresholds favor sensitivity over specificity or vice versa . Regression and correlation tests based on functions of effective sample size are valid , if occasionally conservative , tests for sample size effects . Empirical evidence suggests that they have adequate power to be useful tests . When DORs are heterogeneous , however , all tests of funnel plot asymmetry have low power . CONCLUSION Existing tests that use st and ard errors of odds ratios are likely to be seriously misleading if applied to meta-analyses of test accuracy . The effective sample size funnel plot and associated regression test of asymmetry should be used to detect publication bias and other sample size related effects A reduction of either blood pressure or glycemia decreases some microvascular complications of type 2 diabetes , and we studied here their combined effects . In total , 4733 older adults with established type 2 diabetes and hypertension were r and omly assigned to intensive ( systolic blood pressure less than 120 mm Hg ) or st and ard ( systolic blood pressure less than 140 mm Hg ) blood pressure control , and separately to intensive ( HbA1c less than 0.060 ) or st and ard ( HbA1c 0.070 - 0.079 ) glycemic control . Prespecified microvascular outcomes were a composite of renal failure and retinopathy and nine single outcomes . Proportional hazard regression models were used without correction for type I error due to multiple tests . During a mean follow-up of 4.7 years , the primary outcome occurred in 11.4 % of intensive and 10.9 % of st and ard blood pressure patients ( hazard ratio 1.08 ) , and in 11.1 % of intensive and 11.2 % of st and ard glycemia control patients . Intensive blood pressure control only reduced the incidence of microalbuminuria ( hazard ratio 0.84 ) , and intensive glycemic control reduced the incidence of macroalbuminuria and a few other microvascular outcomes . There was no interaction between blood pressure and glycemic control , and neither treatment prevented renal failure . Thus , in older patients with established type 2 diabetes and hypertension , intensive blood pressure control improved only 1 of 10 prespecified microvascular outcomes . None of the outcomes were significantly reduced by simultaneous intensive treatment of glycemia and blood pressure , signifying the lack of an additional beneficial effect from combined treatment BACKGROUND No study has yet investigated the validity of prescreening by albumin measurements in a spot morning urine sample to identify in the general population subjects with microalbuminuria . We therefore tested the diagnostic performance of urinary albumin concentration ( UAC ) and albumin-creatinine ratio ( ACR ) , measured in a spot morning urine sample , in predicting a urinary albumin excretion ( UAE ) > or = 30 mg in subsequent 24-hour urines ( microalbuminuria ) . METHODS Subjects ( 2527 ) participating in the PREVEND study , a representative sample from the general population , collected a spot morning urine sample and , on average , 77 days later , two 24-hour urine collection s. RESULTS The ROC curve of UAC in predicting microalbuminuria has an area-under-the-curve of 0.92 with a discriminator value of 11.2 mg/L. Using this cut-off value for UAC , sensitivity in predicting microalbuminuria is 85.0 % , and specificity 85.0 % . For ACR these values are , respectively : area-under-the-curve 0.93 , discriminator value 9.9 mg/g , sensitivity 87.6 % , and specificity 87.5 % . Sensitivity for UAC in predicting microalbuminuria does not differ significantly from the sensitivity for ACR , whereas the difference between the specificities of UAC and ACR reaches statistical significance , but is numerically very small . In various subgroups characterized by differences in urinary creatinine excretion , the area-under-the-ROC curve , sensitivity , as well as specificity , do not increase relevantly compared to the results in the overall study population . This holds true for ACR as well as UAC . CONCLUSION The diagnostic performance of measuring UAC in a spot morning urine sample in predicting microalbuminuria in subsequent 24-hour urine collection s is satisfactory , and , moreover , comparable to that of measuring ACR . In order to keep the burden and costs involved in population screening for microalbuminuria as low as possible , we therefore propose prescreening by measuring UAC in a spot morning urine sample . Those subjects with a UAC above a certain predefined level ( e.g. , 11 mg/L ) should be asked to collect timed urine sample Summary Non-insulin-dependent diabetes mellitus ( NIDDM ) is associated with premature mortality , generally thought to be exaggerated in patients with microalbuminuria . This prospect i ve 8-year follow-up study aim ed to determine outcome , mortality and cause of death in NIDDM patients with abnormal urinary albumin excretion compared to those with normal albumin excretion . We recruited 153 NIDDM patients with abnormal urinary albumin excretion and 153 control subjects with albumin excretion within the normal non-diabetic range , matched for age , sex and duration of diabetes , from three University hospital diabetic clinics in Newcastle upon Tyne . The outcome measures were status at follow-up , mortality and cause of death . Subjects with abnormal albumin excretion had a significantly higher 8-year mortality than matched control subjects ( Odds Ratio 1.47 , p=0.02 ; 108 vs 66 per 1000 person years follow-up , p<0.001 ) . This difference was seen at all levels of abnormal albumin excretion , from just outside the normal range ( 10.6–29.9 Μg/min : 104 vs 61 per 1000 person years follow-up , p<0.001 ) to more conventional definitions of microalbuminuria ( ⩾30 Μg/min : 111 vs 71 per 1000 person years follow-up , p<0.01 ) . Those with abnormal albumin excretion had an excess of vascular deaths compared to matched control subjects ( Odds Ratio 1.70 , p = 0.009 ) , again at different levels of albumin excretion ( 10.6–29.9 Μg/min p<0.01 , 30–150 Μg/min p<0.05 ) . On multivariate analysis , age , initial ischaemic heart disease and initial albumin excretion rates were independent predictors of death from all causes . Even a minor elevation of albumin excretion above the normal non-diabetic range is associated with excess mortality from vascular causes in NIDDM |
1,361 | 18,761,648 | Combined data from all trials showed that the CSII group compared with the MDI group experienced a significant reduction in the level of glycosylated hemoglobin .
In short-term insulin therapy , CSII compared with MDI is a more effective form of metabolic control and allows reducing the daily insulin requirement .
Yet , no conclusions have been made so far whether this effect holds in later years . | OBJECTIVE To investigate potential effects of continuous subcutaneous insulin infusion ( CSII ) compared with multiple daily injections ( MDI ) on glycemic control in children with type 1 diabetes mellitus ( T1DM ) . | BACKGROUND Continuous subcutaneous insulin infusion ( CSII ) is believed to decrease glycemic variability and clinical hypoglycemia compared with the multiple daily insulin ( MDI ) regimen . To compare the indices of glycemic instability between CSII and MDI , we analyzed the continuous glucose monitoring system ( CGMS ) ( Medtronic MiniMed , Northridge , CA ) profiles of a group of children with type 1 diabetes mellitus with history of frequent blood glucose ( BG ) fluctuations and hypoglycemia . PATIENTS AND METHODS Data from 14 ( nine girls , five boys ) patients ( 3.9 - 16.8 years old ) on CSII and 14 age- and sex-matched ( nine girls , five boys ) patients ( 3.9 - 16.0 years old ) on MDI with similar glycemic control ( hemoglobin A1c : 7.9 + /- 1.0 % vs. 7.9 + /- 1.5 % ) and body mass index ( BMI ) ( 20.1 + /- 4.3 vs. 19.9 + /- 4.1 kg/m(2 ) ) were evaluated by the CGMS . Mean BG ( MBG ) , absolute means of daily differences ( MODD ) , mean amplitude of glycemic excursion ( MAGE ) , and number of hypoglycemic events ( BG < 60 mg/dL ) for 48 h were calculated . RESULTS The MBG , MODD , MAGE , and number and mean duration of hypoglycemia events in the CSII group were similar to those in the MDI group . The MAGE had an inverse correlation with age ( CSII : r ( 2 ) = 0.52 , P = 0.003 ; MDI : r ( 2 ) = 0.29 , P < 0.04 ) and BMI ( CSII : r ( 2 ) = 0.38 , P < 0.02 ; MDI : r ( 2 ) = 0.71 , P < 0.0002 ) . However , there was a positive relationship between MAGE and bolus : basal insulin ratio in the CSII ( r ( 2 ) = 0.28 , P < 0.05 ) and MDI ( r ( 2 ) = 0.33 , P < 0.03 ) groups . Also , the MAGE had a positive correlation with frequency of hypoglycemic events in the CSII ( r ( 2 ) = 0.44 , P < 0.01 ) and MDI ( r ( 2 ) = 0.35 , P < 0.03 ) groups . CONCLUSIONS The CSII and MDI regimens in children and adolescents with comparable glycemic control displayed similar patterns of glycemic excursions , implying that factors influencing glycemic instability in pediatric type 1 diabetes mellitus appear to be independent of treatment modality OBJECTIVE To compare the efficacy of 2 intensified insulin regimens , continuous subcutaneous insulin infusion ( CSII ) and multiple daily injections ( MDI ) , by using the short-acting insulin analog lispro in type 1 diabetic patients . RESEARCH DESIGN AND METHODS A total of 41 C-peptide-negative type 1 diabetic patients ( age 43.5+/-10.3 years ; 21 men and 20 women , BMI 24.0+/-2.4 kg/m2 , diabetes duration 20.0+/-11.3 years ) on intensified insulin therapy ( MDI with regular insulin or lispro , n = 9 , CSII with regular insulin , n = 32 ) were included in an open-label r and omized crossover study comparing two 4-month periods of intensified insulin therapy with lispro : one period by MDI and the other by CSII . Blood glucose ( BG ) was monitored before and after each of the 3 meals each day . RESULTS The basal insulin regimen had to be optimized in 75 % of the patients during the MDI period ( mean number of NPH injections per day = 2.65 ) . HbA1c values were lower when lispro was used in CSII than in MDI ( 7.89+/-0.77 vs. 8.24+/-0.77 % , P<0.001 ) . BG levels were lower with CSII ( 165+/-27 vs. 175+/-33 mg/dl , P<0.05 ) . The SD of all the BG values ( 73+/-15 vs. 82+/-18 mg/dl , P<0.01 ) was lower with CSII . The frequency of hypoglycemic events , defined as BG levels < 60 mg/dl , did not differ significantly between the 2 modalities ( CSII 3.9+/-4.2 per 14 days vs. MDI 4.3+/-3.9 per 14 days ) . Mean insulin doses were significantly lower with CSII than with MDI ( 38.5+/-9.8 vs. 47.3+/-14.9 U/day . respectively , P < 0.0001 ) . CONCLUSIONS When used with external pumps versus MDI , lispro provides better glycemic control and stability with much lower doses of insulin and does not increase the frequency of hypoglycemic episodes OBJECTIVE This study assesses the effects of insulin pump therapy on diabetes control and family life in children 1 - 6 years old with type 1 diabetes . RESEARCH DESIGN AND METHODS Twenty-six children with type 1 diabetes for > /=6 months were r and omly assigned to current therapy ( two or three shots per day using NPH insulin and rapid-acting analog ) or continuous subcutaneous insulin infusion ( CSII ) for 6 months . After 6 months , current therapy subjects were offered CSII . Changes in HbA(1c ) , mean blood glucose ( MBG ) , hypoglycemia frequency , diabetes-related quality of life ( QOL ) , and parental adjustment were recorded . RESULTS Eleven subjects from each group completed the trial ( age 46.3 + /- 3.2 months [ means + /- SE ] ) . At baseline , there were no differences between groups in HbA(1c ) , MBG , age , sex , diabetes duration , or parental QOL . Mean HbA(1c ) , MBG , and parental QOL were similar between groups at 6 months . Mean HbA(1c ) and MBG did not change from baseline to 6 months in either group . The frequency of severe hypoglycemia , ketoacidosis , or hospitalization was similar between groups at any time period . Subjects on CSII had more fasting and predinner mild/moderate hypoglycemia at 1 and 6 months . Diabetes-related QOL improved in CSII fathers from baseline to 6 months . Psychological distress increased in current therapy mothers from baseline to 6 months . All subjects continued CSII after study completion . CONCLUSIONS CSII is safe and well tolerated in young children with diabetes and may have positive effects on QOL . CSII did not improve diabetes control when compared with injections , despite more mild/moderate hypoglycemia . The benefits and realistic expectations of CSII should be thoroughly examined before starting this therapy in very young children OBJECTIVE To compare glycemic patterns by mode of therapy in children with type 1 diabetes mellitus using the Continuous Glucose Monitoring System ( CGMS ) . DESIGN Open r and omized crossover comparing 3(1/2 ) months of multiple daily injections ( MDI ) and continuous subcutaneous insulin infusion ( CSII ) . SETTING Tertiary care , university-affiliated medical center . Patients Twenty-three children and adolescents with type 1 diabetes mellitus . INTERVENTIONS The CGMS was applied for 72 hours after 1 month and at the end of each study arm . MAIN OUTCOME MEASURES Hemoglobin A(1c ) levels and glucose level profiles were compared between the 2 study arms and the 2 sensor applications for each arm . RESULTS The arms were similar for mean ( SD ) hemoglobin A(1c ) levels ( CSII , 8.0 % [ 0.8 % ] ; and MDI , 8.2 % [ 0.8 % ] ) and glucose levels . Areas under the curve were significantly larger during MDI for nocturnal and 24-hour hypoglycemia ( P = .01 and .04 , respectively ) and for postpr and ial hypoglycemia and hyperglycemia ( P = .03 and .05 , respectively ) . The rate of hyperglycemia increased during CSII ( P = .03 ) , but 24-hour duration and area under the curve for hyperglycemia were similar . Compared with the first CGMS reading in each arm , the second had a longer mean duration of postpr and ial within-target glucose levels ( P = .04 ) , tendency for lower rate of diurnal hypoglycemic events ( P = .1 ) , shorter duration of nocturnal hypoglycemia ( P = .05 ) , and smaller 24-hour area under the curve for hypoglycemia ( P = .04 ) . CONCLUSIONS Intensive treatment with CSII seemed to be associated with slightly better prebreakfast , postpr and ial , and within-target glucose profiles than MDI , as well as a smaller area under the curve for hypoglycemia . Lower hypoglycemia-related variables in the second sensor reading in each arm indicate that the CGMS may serve as an educational tool to decrease the rate and magnitude of hypoglycemia OBJECTIVE The efficacy of the insulin analogs now available for multiple daily injection ( MDI ) and continuous subcutaneous insulin infusion ( CSII ) therapy in type 1 diabetes has not yet been established in pediatric patients . Our principal aim in this short-term study was to compare the efficacy of CSII to MDI with glargine in lowering HbA(1c ) levels in children and adolescents with type 1 diabetes . RESEARCH DESIGN AND METHODS Thirty-two youth with type 1 diabetes ( age 8 - 21 years ) were r and omly assigned to receive either MDI treatment with once-daily glargine and premeal/snack insulin aspart or CSII with insulin aspart . Dose titration in both groups was based on home self-monitored blood glucose measurements and monthly HbA(1c ) . HbA(1c ) , total daily insulin dose ( TDD ) , self-monitored blood glucose readings , and adverse events were compared after 16 weeks of therapy . RESULTS While there was no significant change in the glargine group ( HbA(1c ) 8.2 % at baseline vs. 8.1 % at 16 weeks ) , youth r and omized to CSII had a sharp reduction in HbA(1c ) levels , from 8.1 to 7.2 % after 16 weeks of therapy ( P < 0.02 vs. baseline and < 0.05 vs. glargine group ) . TDD was unchanged in the glargine group , but significantly dropped with CSII ( 1.4 units/kg at baseline vs. 0.9 units/kg at 16 weeks , P < 0.01 ) . Both groups had similar basal doses and insulin-to-carbohydrate ratios . Fasting self-monitored blood glucose was similar in both groups , but lunch , dinner , and bedtime readings were significantly lower in the CSII group ( P < 0.01 ) . CONCLUSIONS Lower HbA(1c ) and premeal glucose levels were more achievable in this short-term study with CSII than with glargine-based MDI treatment . CSII is an efficacious treatment to improve metabolic control in youth with type 1 diabetes OBJECTIVE To examine the efficacy and safety of using continuous subcutaneous insulin infusion ( CSII ) therapy in a large group of patients 18 months to 18 yr from a single pediatric diabetes program . RESEARCH DESIGN AND METHODS All patients < or = 18 yr of age starting on CSII from 1 January 1997 to 31 March 2000 at the Yale Children 's Diabetes Program were included . Clinical data were collected prospect ively before and during pump treatment . HbA1c was the primary efficacy outcome and rates of diabetes-related adverse events were the primary safety measures . RESULTS One hundred and sixty-one children ranging in age from 18 months to 18 yr received CSII for an average of 32 + /- 9 months when data collection was closed on 31 October 2001 , including 26 preschoolers ( < 7 yr ) , 76 school-agers ( 7 - 11 yr ) and 59 adolescents ( 12 - 18 yr ) . Mean HbA1c levels were 7.1 % in the preschoolers , 7.8 % in the school-agers and 8.1 % in the adolescents prior to the start of CSII . There was a significant and consistent reduction in mean HbA1c levels after 12 months of CSII ( to 6.5 % in preschoolers , 7.3 % in school-agers and 7.4 % in adolescents , p < 0.02 vs. prepump ) that was maintained at the most recent visit . Improved diabetes control was achieved with CSII without increasing daily insulin doses and in association with a decrease in the frequency of severe hypoglycemic events ( p < 0.05 vs. prepump , all three age groups combined ) . CONCLUSIONS CSII is an effective alternative to injection therapy in a large pediatric diabetes clinic setting . Even very young patients can utilize CSII to safely lower HbA1c levels OBJECTIVE To compare the efficacy of the short-acting insulin analog lispro ( LP ) with that of regular insulin in IDDM patients treated with an external pump . RESEARCH DESIGN AND METHODS Thirty-nine IDDM patients ( age , 39.4 ± 1.5 years ; sex ratio , 22M/17W ; BMI , 24.4 ± 0.4 kg/m2 ; diabetes duration , 22.5 ± 1.6 years ) who were treated by external pump for 5.1 ± 0.5 years were involved in an open-label , r and omized , crossover multicenter study comparing two periods of 3 months of continuous subcutaneous insulin infusion with LP or with Actrapid HM , U-100 ( ACT ) . Boluses were given 0–5 min ( LP ) or 20–30 min ( ACT ) before meals . Blood glucose ( BG ) was monitored before and after the three meals every day . RESULTS The decrease in HbA1c was more pronounced with LP than with ACT ( −0.62 ± 0.13 vs. −0.09 ± 0.15 % , P = 0.01 ) . BG levels were lower with LP ( 7.93 ± 0.15 vs. 8.61 ± 0.18 mmol/l , P < 0.0001 ) , particularly postpr and ial BG levels ( 8.26 ± 0.19 vs. 9.90 ± 0.20 mmol/l , P < 0.0001 ) . St and ard deviations of all the BG values ( 3.44 ± 0.10 vs. 3.80 ± 0.10 mmol/l , P = 0.0001 ) and of postpr and ial BG values ( 3.58 ± 0.10 vs. 3.84 ± 0.10 mmol/l . P < 0.02 ) were lower with LP . The rate of hypoglycemic events defined by BG < 3.0 mmol/l did not significantly differ between LP and ACT ( 7.03 ± 0.94 vs. 7.94 ± 0.88 per month , respectively ) , but the rate of occurrences of very low BG , defined as BG < 2.0 mmol/l , were significantly reduced with LP ( 0.05 ± 0.05 vs. 0.47 ± 0.19 per month , P < 0.05 ) . At the end of the study , all but two ( 95 % ) of the patients chose LP for the extension phase . CONCLUSIONS When used in external pumps , LP provides better glycemic control and stability than regular insulin and does not increase the frequency of hypoglycemic episodes OBJECTIVE Our goals were to determine if continuous subcutaneous insulin infusion ( CSII ) , compared with those continuing multiple daily injections ( MDIs ) , can be safely used in young children , if those on CSII will have superior glycemic control , if subjects using CSII will have less hypoglycemia for their level of control , and if families using CSII will report an improved quality of life . RESEARCH DESIGN AND METHODS We conducted a r and omized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type 1 diabetes for at least 6 months ' duration . Prospect i ve outcomes included measures of overall glycemic control ( HbA1c and continuous glucose monitoring system ) , the incidence of severe hypoglycemia and diabetic ketoacidosis , the percent of glucose values below 3.9 mmol/l , and the parents ' report of quality of life . RESULTS The 19 subjects ' ages ranged from 1.7 to 6.1 ( mean 3.6 ) years , duration of diabetes ranged from 0.6 to 2.6 ( mean 1.4 ) years , and baseline HbA1c ranged from 6.7 to 9.6 % ( mean 7.9 % ) . Seven subjects were male . Nine subjects were r and omized to start CSII and 10 to continue on MDI . All baseline characteristics were well balanced . Overall metabolic control , diabetes quality of life , and the incidence of hypoglycemia were similar in the two groups . No subject had diabetic ketoacidosis , while one subject in each group had an episode of severe hypoglycemia . No CSII subject discontinued using the pump during or after the study . CONCLUSIONS CSII can be a safe and effective method to deliver insulin in young children Twenty insulin-dependent diabetic patients participated in a 1-yr prospect i ve r and omized cross-over study comparing multiple subcutaneous injections ( MSI ) and continuous subcutaneous insulin infusion ( CSII ) complemented by home blood glucose monitoring . While 4 patients dropped out early , 16 patients completed the study . Patients had severe insulin deficiency documented by absent C-peptide response to glucagon stimulation . A marked improvement in control was observed when mean blood glucose and glycosylated hemoglobin A1 were compared with conventional therapy . No significant differences in the degree of metabolic control achieved , as measured by mean fasting , prepr and ial , and postpr and ial capillary blood glucose ( CBG ) , M values , glycosylated hemoglobin A1 concentration , cholesterol and triglyceride levels were seen between MSI and CSII in the sixteen patients who completed the study . However , individual comparisons showed that fasting CBG and M-values were lower under CSII than MSI in seven patients ( P < 0.05 ) . In contrast , two patients exhibited lower M values under MSI than under CSII ( P < 0.01 ) , while for the remaining seven patients the results were similar . After completion of the study , two patients went back to conventional insulin therapy , seven patients remained on the pump , and seven patients chose to stay on MSI . In conclusion , on a long-term basis , the two methods can produce comparable levels of blood glucose and glycosylated hemoglobin in ambulatory insulin-dependent diabetics OBJECTIVE To compare the efficacy and feasibility of continuous subcutaneous insulin infusion ( CSII ) with multiple daily insulin injections ( MDI ) in children with type 1 diabetes . METHODS The study sample included 23 children ( 10 males ) aged 9.4 to 13.9 years with type 1 diabetes . An open r and omized crossover design was used to compare 3.5 months of CSII to 3.5 months of MDI therapy for the following variables : diabetic control , incidence of adverse events , daily insulin requirement , body mass index st and ard deviation scores , treatment satisfaction , and quality of life . RESULTS The changes in HbA(1c ) and fructoseamine values were similar in the 2 arms over time . At the end of the study , mean HbA(1c ) level measured 8.05 + /- 0.78 % . There were no differences between the treatment modes in frequency of symptomatic hypoglycemic or hyperglycemic events . There was 1 event of severe hypoglycemia during pump therapy and 3 during MDI , yielding a rate of 0.26 events per patient-year . There were no episodes of diabetic ketoacidosis . Body mass index st and ard deviation scores decreased during CSII and increased during MDI , as did mean insulin dose . Patients expressed a higher treatment satisfaction from CSII than MDI , although there was no difference in quality of life between the 2 modes . CONCLUSIONS Intensive insulin therapy by either insulin pump or MDI is safe in children and young adolescents with type 1 diabetes , with similar diabetes control and a very low rate of adverse events . We suggest that both modes be available to the diabetic team to better tailor therapy OBJECTIVE To compare glycemic control , safety , and parental satisfaction in preschool-aged diabetic children r and omized to treatment either with continuous subcutaneous insulin infusion ( CSII ) or intensive insulin injection therapy . STUDY DESIGN This clinical trial enrolled 42 patients < 5 years of age who had been diagnosed with diabetes for at least 12 months . Children were r and omly assigned to CSII ( n = 21 ) or intensive insulin injection therapy ( n = 21 ) . Hemoglobin A1c ( HbA1c ) level was measured at baseline , 3 , and 6 months . Secondary outcomes included severe hypoglycemic events , meter-detected hypoglycemia , blood sugar variability , body mass index ( BMI ) , and satisfaction with therapy . RESULTS Thirty-seven patients completed 6 months of therapy . There was a significant decrease in HbA1c during the study period for both groups ( from 8.9 % + /- 0.6 % to 8.6 % + /- 0.6 % at 3- and 6-month visits ) . At 3 months , children using pumps had a significantly lower HbA1c than the injection group ( 8.4 % vs 8.8 % ) ; however , by 6 months the two groups were similar ( 8.5 % vs 8.7 % ) . No differences in pre-meal blood sugar variabilities were seen between groups . Children on pumps had increases in the number of meter-detected episodes of hypoglycemia . Pump therapy was safe and well tolerated . No episodes of ketoacidosis occurred in either group , whereas one hypoglycemic seizure occurred in each group . Parents reported satisfaction with CSII , with 95 % of families continuing on CSII beyond the 6-month study period . CONCLUSION Pump therapy in preschool-aged children was not associated with clinical ly significant differences in glycemic control as compared with intensive injection therapy . The rationale for initiating CSII in this age group should be based on patient selection and lifestyle preference OBJECTIVE To examine the effect of continuous subcutaneous insulin infusion ( CSII ) therapy on parameters affecting long-term outcome in type 1 diabetes . Study design Height , weight , body mass index , insulin dose , glycosylated hemoglobin ( HbA(1C ) ) , and blood glucose data from home meter downloads were collected prospect ively for analysis in 51 children ( age , 10.7+/-3.1 years , mean+/-SD ) throughout the 12 months before and after introducing CSII . RESULTS Before pump initiation , HbA(1C ) was relatively stable , but it fell to 7.7+/-0.2 % ( P<.001 ) within 3 months of CSII and remained decreased ( 7.9+/-0.1 % ) at 12 months ( P<.01 ) . In contrast , weight st and ard deviation score increased before CSII ( from 0.50+/-0.13 to 0.60+/-0.13 , P<.05 ) , but remained unchanged ( 0.61+/-0.11 ) in the year thereafter . Although severe hypoglycemia ( < 50 mg/dL ) was reduced in the entire cohort , HbA(1C ) improved primarily in young children and teenagers . Comparison of glycemic responders ( HbA(1C ) < 7.5 , or a decrease > 1 % on CSII , n=23 ) with nonresponders demonstrated no differences with respect to gender , socioeconomic status , weight st and ard deviation score , body mass index , initial HbA(1C ) , frequency of hypoglycemia , or number of education visits before CSII . CONCLUSION Continuous subcutaneous insulin infusion is effective in lowering HbA(1C ) and the occurrence of severe nocturnal hypoglycemia without excessive weight gain in most children with type 1 diabetes . HbA(1C ) response to CSII is poorer in preadolescents than in young children or teenagers |
1,362 | 27,654,329 | In summary , the results from this meta- analysis do not favor any clinical efficacy of blueberry supplementation in improving BP . | Blueberries belong to the genus Vaccinium of the family Ericaceae .
A series of epidemiological studies have demonstrated that blueberry polyphenols , particularly blueberry anthocyanins provide significant beneficial effects for humans .
However , the findings of clinical studies have been equivocal .
Therefore , we sought to assess the potential anti-hypertensive effects of blueberry supplementation through a meta- analysis of available r and omized controlled trials ( RCTs ) . | CONTEXT Few cardiovascular outcome data are available for blacks with hypertension treated with angiotensin-converting enzyme ( ACE ) inhibitors or calcium channel blockers ( CCBs ) . OBJECTIVE To determine whether an ACE inhibitor or CCB is superior to a thiazide-type diuretic in reducing cardiovascular disease ( CVD ) incidence in racial subgroups . DESIGN , SETTING , AND PARTICIPANTS Prespecified subgroup analysis of ALLHAT , a r and omized , double-blind , active-controlled , clinical outcome trial conducted between February 1994 and March 2002 in 33,357 hypertensive US and Canadian patients aged 55 years or older ( 35 % black ) with at least 1 other cardiovascular risk factor . INTERVENTIONS Antihypertensive regimens initiated with a CCB ( amlodipine ) or an ACE inhibitor ( lisinopril ) vs a thiazide-type diuretic ( chlorthalidone ) . Other medications were added to achieve goal blood pressures ( BPs ) less than 140/90 mm Hg . MAIN OUTCOME MEASURES The primary outcome was combined fatal coronary heart disease ( CHD ) or nonfatal myocardial infa rct ion ( MI ) , analyzed by intention-to-treat . Secondary outcomes included all-cause mortality , stroke , combined CVD ( CHD death , nonfatal MI , stroke , angina , coronary revascularization , heart failure [ HF ] , or peripheral vascular disease ) , and end-stage renal disease . RESULTS No significant difference was found between treatment groups for the primary CHD outcome in either racial subgroup . For amlodipine vs chlorthalidone only , HF was the only prespecified clinical outcome that differed significantly ( overall : relative risk [ RR ] , 1.37 ; 95 % confidence interval [ CI ] , 1.24 - 1.51 ; blacks : RR , 1.46 ; 95 % CI , 1.24 - 1.73 ; nonblacks : RR , 1.32 ; 95 % CI , 1.17 - 1.49 ; P<.001 for each comparison ) with no difference in treatment effects by race ( P = .38 for interaction ) . For lisinopril vs chlorthalidone , results differed by race for systolic BP ( greater decrease in blacks with chlorthalidone ) , stroke , and combined CVD outcomes ( P<.001 , P = .01 , and P = .04 , respectively , for interactions ) . In blacks and nonblacks , respectively , the RRs for stroke were 1.40 ( 95 % CI , 1.17 - 1.68 ) and 1.00 ( 95 % CI , 0.85 - 1.17 ) and for combined CVD were 1.19 ( 95 % CI , 1.09 - 1.30 ) and 1.06 ( 95 % CI , 1.00 - 1.13 ) . For HF , the RRs were 1.30 ( 95 % CI , 1.10 - 1.54 ) and 1.13 ( 95 % CI , 1.00 - 1.28 ) , with no significant interaction by race . Time-dependent BP adjustment did not significantly alter differences in outcome for lisinopril vs chlorthalidone in blacks . CONCLUSIONS In blacks and nonblack subgroups , rates were not lower in the amlodipine or lisinopril groups than in the chlorthalidone group for either the primary CHD or any other prespecified clinical outcome , and diuretic-based treatment result ed in the lowest risk of heart failure . While the improved outcomes with chlorthalidone were more pronounced for some outcomes in blacks than in nonblacks , thiazide-type diuretics remain the drugs of choice for initial therapy of hypertension in both black and nonblack hypertensive patients ABSTRACT Introduction : The use of herbal medicines including different types of tea is among the different strategies for preventing and controlling the side-effects of diabetes . The aim of the present study was to compare the effect of sour tea and green tea on mildly hypertensive patients with diabetes . Methods : The present study was a r and omized clinical trial in which 100 mildly hypertensive patients with diabetes were r and omly assigned into sour tea group ( ST ) and green tea group ( GT ) . They were instructed to drink sour tea and green tea infusion , respectively , three times a day 2 hr after each meal for 4 weeks . The participants ’ blood pressure was measured at days 1 , 15 , and at the end of study . Results : The systolic pressure of both groups statistically decreased at the end of the study ; it decreased from 123.1 ± 15.5 to 116.8 ± 16.3 mmHg in the ST and from 119.4 ± 15.1 to 114.8 ± 15.9 mmHg in the GT . The diastolic pressure of both groups statistically decreased by the end of the study ; it decreased from 79.4 ± 11.1 to 74.5 ± 9.3 mmHg in the ST and from 78.9 ± 8.3 to 75.3 ± 7.7 mmHg in the GT . The therapeutic effectiveness of tea drinking by the end of intervention was 43.5 % in the ST and 39.6 % in the GT compared to the beginning . Conclusions : The present study revealed that mildly hypertensive type 2 diabetic individuals who drink three glasses of green or sour tea daily for 4 weeks show significant decreased systolic and diastolic blood pressures Evidence suggests that berries contain bioactive compounds , which reduce certain cancers and hypertension . Our hypothesis was that daily blueberry ( BB ) consumption would increase natural killer ( NK ) cells and plasma redox capacity and reduce blood pressure , augmentation index ( AIx ) , central pulse wave velocity , and aortic systolic pressures ( ASPs ) . Twenty-five men and postmenopausal women aged 18 to 50 years were recruited and r and omized to BB ( n , 13 ) or placebo groups ( n , 12 ) . Participants were provided with BB ( equivalent to 250 g berries ) or placebo powders each day for 6 weeks . Blood pressure , vascular performance testing , and blood sample s were taken at baseline ( presupplementation ) . Participants returned after 6 weeks and repeated all procedures . Presupplementation to postsupplementation comparisons for the main effects of treatment , time , and treatment-time interaction were made using a 2 ( treatment ) × 2 ( times ) repeated- measures analysis of variance for all vascular measures , redox status , and NK cell counts . Anthropometric measures were compared using t tests . Body mass , composition , and overall blood pressures were not affected in either group . Overall , AIx and ASPs were decreased in BB ( treatment effect , P = .024 and P = .046 , respectively ) . Plasma redox was not affected . Absolute NK cells were increased in BB ( time , P = .001 and interaction , P = .012 ) . Subjects ( n , 9 ) with prehypertensive pressures ( ≥120/80 mm Hg , respectively ) were examined as a subset using t tests and exhibited significant reductions in diastolic pressure ( P = .038 ) from presupplementation to postsupplementation in BB . We conclude that BB ingestion for 6 weeks increases NK cells and reduces AIx , ASP , and diastolic pressures in sedentary males and females Dietary supplementation with whole blueberries in a pre clinical study result ed in a reduction in glucose concentrations over time . We sought to evaluate the effect of daily dietary supplementation with bioactives from blueberries on whole-body insulin sensitivity in men and women . A double-blinded , r and omized , and placebo-controlled clinical study design was used . After screening to resolve study eligibility , baseline ( wk 0 ) insulin sensitivity was measured on 32 obese , nondiabetic , and insulin-resistant subjects using a high-dose hyperinsulinemic-euglycemic clamp ( insulin infusion of 120 mU(861 pmol)⋅m(-2)⋅min(-1 ) ) . Serum inflammatory biomarkers and adiposity were measured at baseline . At the end of the study , insulin sensitivity , inflammatory biomarkers , and adiposity were reassessed . Participants were r and omized to consume either a smoothie containing 22.5 g blueberry bioactives ( blueberry group , n = 15 ) or a smoothie of equal nutritional value without added blueberry bioactives ( placebo group , n = 17 ) twice daily for 6 wk . Both groups were instructed to maintain their body weight by reducing ad libitum intake by an amount equal to the energy intake of the smoothies . Participants ' body weights were evaluated weekly and 3-d food records were collected at baseline , the middle , and end of the study . The mean change in insulin sensitivity improved more in the blueberry group ( 1.7 ± 0.5 mg⋅kg FFM(-1)⋅min(-1 ) ) than in the placebo group ( 0.4 ± 0.4 mg⋅kg FFM(-1)⋅min(-1 ) ) ( P = 0.04 ) . Insulin sensitivity was enhanced in the blueberry group at the end of the study without significant changes in adiposity , energy intake , and inflammatory biomarkers . In conclusion , daily dietary supplementation with bioactives from whole blueberries improved insulin sensitivity in obese , nondiabetic , and insulin-resistant participants BACKGROUND Dietary flavonoids have beneficial effects on blood pressure in intervention setting s , but there is limited information on habitual intake and risk of hypertension in population -based studies . OBJECTIVE We examined the association between habitual flavonoid intake and incident hypertension in a prospect i ve study in men and women . DESIGN A total of 87,242 women from the Nurses ' Health Study ( NHS ) II , 46,672 women from the NHS I , and 23,043 men from the Health Professionals Follow-Up Study ( HPFS ) participated in the study . Total flavonoid and subclass intakes were calculated from semiquantitative food-frequency question naires collected every 4 y by using an up date d and extended US Department of Agriculture data base . RESULTS During 14 y of follow-up , 29,018 cases of hypertension in women and 5629 cases of hypertension in men were reported . In pooled multivariate-adjusted analyses , participants in the highest quintile of anthocyanin intake ( predominantly from blueberries and strawberries ) had an 8 % reduction in risk of hypertension [ relative risk ( RR ) : 0.92 ; 95 % CI : 0.86 , 0.98 ; P < 0.03 ] compared with that for participants in the lowest quintile of anthocyanin intake ; the risk reduction was 12 % ( RR : 0.88 ; 95 % CI : 0.84 , 0.93 ; P < 0.001 ) in participants ≤60 y of age and 0.96 ( 0.91 , 1.02 ) in participants > 60 y of age ( P for age interaction = 0.02 ) . Although intakes of other subclasses were not associated with hypertension , pooled analyses for individual compounds suggested a 5 % ( 95 % CI : 0.91 , 0.99 ; P = 0.005 ) reduction in risk for the highest compared with the lowest quintiles of intake of the flavone apigenin . In participants ≤60 y of age , a 6 % ( 95 % CI : 0.88 , 0.97 ; P = 0.002 ) reduction in risk was observed for the flavan-3-ol catechin when the highest and the lowest quintiles were compared . CONCLUSIONS Anthocyanins and some flavone and flavan-3-ol compounds may contribute to the prevention of hypertension . These vasodilatory properties may result from specific structural similarities ( including the B-ring hydroxylation and methyoxylation pattern ) OBJECTIVE Evaluation of the vitro antioxidant activity of green and black tea , their in vivo effect on plasma antioxidant potential in man and the effect of milk addition . DESIGN The antioxidant activity of the tea , with and without milk , was tested in vitro by measuring the length of the peroxyl radical induced lag-phase . The in vivo activity was tested on two groups of five healthy adults . Each group ingested 300 ml of either black or green tea , after overnight fast . The experiment was repeated on a separate day , adding 100 ml whole milk to the tea ( ratio 1:4 ) . Five subjects acted as controls . The human plasma antioxidant capacity ( TRAP ) was measured before and 30 , 50 and 80 min from the ingestion of tea . RESULTS Both teas inhibited the in vitro peroxidation in a dose-dependent manner . Green tea was sixfold more potent than black tea . The addition of milk to either tea did not appreciably modify their in vitro antioxidant potential . In vivo , the ingestion of tea produced a significant increase of TRAP ( P < 0.05 ) , similar in both teas , which peaked at 30 - 50 min . When tea was consumed with milk , their in vivo activity was totally inhibited . CONCLUSIONS The paper shows that tea possesses a strong antioxidant activity in vitro which is believed to be exerted by its polyphenols moiety . It also provides compelling evidence that tea has also a potent in vivo activity in man . The promptness of the in vivo response suggests that the absorption of the bioactive components of tea takes place in the upper part of the gastrointestinal system . The inhibition of this effect by milk is thought to be due to the complexation of tea polyphenols by milk proteins . These findings might help to clarify the putative role of dietary poly- phenols in modulating oxidative stress in vivo BACKGROUND Postmenopausal women have a high prevalence of hypertension and often develop arterial stiffness thereby increasing cardiovascular disease risk . Although antihypertensive drug therapies exist , increasing numbers of people prefer natural therapies . In vivo studies and a limited number of clinical studies have demonstrated the antihypertensive and vascular-protective effects of blueberries . OBJECTIVE To examine the effects of daily blueberry consumption for 8 weeks on blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension . DESIGN This was an 8-week , r and omized , double-blind , placebo-controlled clinical trial . PARTICIPANTS / SETTING Forty-eight postmenopausal women with pre- and stage 1-hypertension recruited from the greater Tallahassee , FL , area participated . INTERVENTION Participants were r and omly assigned to receive either 22 g freeze-dried blueberry powder or 22 g control powder . MAIN OUTCOME MEASURES Resting brachial systolic and diastolic blood pressures were evaluated and arterial stiffness was assessed using carotid-femoral pulse wave velocity and brachial-ankle pulse wave velocity . C-reactive protein , nitric oxide , and superoxide dismutase were measured at baseline , 4 weeks , and 8 weeks . STATISTICAL ANALYSES PERFORMED Statistical analysis was performed using a split plot model of repeated measures analysis of variance . RESULTS After 8 weeks , systolic blood pressure and diastolic blood pressure ( 131±17 mm Hg [ P<0.05 ] and 75±9 mm Hg [ P<0.01 ] , respectively ) and brachial-ankle pulse wave velocity ( 1,401±122 cm/second ; P<0.01 ) were significantly lower than baseline levels ( 138±14 mm Hg , 80±7 mm Hg , and 1,498±179 cm/second , respectively ) , with significant ( P<0.05 ) group × time interactions in the blueberry powder group , whereas there were no changes in the group receiving the control powder . Nitric oxide levels were greater ( 15.35±11.16 μmol/L ; P<0.01 ) in the blueberry powder group at 8 weeks compared with baseline values ( 9.11±7.95 μmol/L ) , whereas there were no changes in the control group . CONCLUSIONS Daily blueberry consumption may reduce blood pressure and arterial stiffness , which may be due , in part , to increased nitric oxide production Objective : To investigate the effect of black and green tea consumption , with and without milk , on the plasma antioxidant activity in humans . Design : In a complete cross-over design , 21 healthy volunteers ( 10 male , 11 female ) received a single dose of black tea , green tea ( 2 g tea solids in 300 ml water ) or water with or without milk . Blood sample s were obtained at baseline and at several time points up to 2 h post-tea drinking . Plasma was analysed for total catechins and antioxidant activity , using the ferric reducing ability of plasma ( FRAP ) assay . Results : Consumption of black tea result ed in a significant increase in plasma antioxidant activity reaching maximal levels at about 60 min . A larger increase was observed after consumption of green tea . As anticipated from the higher catechin concentration in green tea , the rise in plasma total catechins was significantly higher after consumption of green tea when compared to black tea . Addition of milk to black or green tea did not affect the observed increases in plasma antioxidant activity . Conclusions : Consumption of a single dose of black or green tea induces a significant rise in plasma antioxidant activity in vivo . Addition of milk to tea does not abolish this increase . Whether the observed increases in plasma antioxidant activity after a single dose of tea prevent in vivo oxidative damage remains to be established . European Journal of Clinical Nutrition ( 2000 ) 54 , Purpose Wild blueberries ( WB ) ( Vaccinium angustifolium ) are rich sources of polyphenols , such as flavonols , phenolic acids and anthocyanins ( ACNs ) , reported to decrease the risk of cardiovascular and degenerative diseases . This study investigated the effect of regular consumption of a WB or a placebo ( PL ) drink on markers of oxidative stress , inflammation and endothelial function in subjects with risk factors for cardiovascular disease . Methods Eighteen male volunteers ( ages 47.8 ± 9.7 years ; body mass index 24.8 ± 2.6 kg/m2 ) received according to a cross-over design , a WB ( 25 g freeze-dried powder , providing 375 mg of ACNs ) or a PL drink for 6 weeks , spaced by a 6-week wash-out . Endogenous and oxidatively induced DNA damage in blood mononuclear cells , serum interleukin levels , reactive hyperemia index , nitric oxide , soluble vascular adhesion molecule concentration and other variables were analyzed . Results Wild blueberry drink intake significantly reduced the levels of endogenously oxidized DNA bases ( from 12.5 ± 5.6 % to 9.6 ± 3.5 % , p ≤ 0.01 ) and the levels of H2O2-induced DNA damage ( from 45.8 ± 7.9 % to 37.2 ± 9.1 % , p ≤ 0.01 ) , while no effect was found after the PL drink . No significant differences were detected for markers of endothelial function and the other variables under study . Conclusions In conclusion , the consumption of the WB drink for 6 weeks significantly reduced the levels of oxidized DNA bases and increased the resistance to oxidatively induced DNA damage . Future studies should address in greater detail the role of WB in endothelial function . This study was registered at www.is rct n.org as IS RCT N47732406 |
1,363 | 29,541,164 | Conclusion Our results suggest that in patients with T2D , lower intensity exercise has physiological meaningful effects on EF , in support of the emerging concept that the lower efforts of exercise are not necessarily less cardioprotective than higher intensity training | Background Vascular endothelial dysfunction induced by hyperglycemia and elevated insulin resistance is a potent risk factor for cardiovascular disease and likely contributes to multiple chronic disease complications associated with aging .
The aim of this study was to systematic ally review and quantify the effects of exercise on endothelial function ( EF ) in type 2 diabetes ( T2D ) . | Muscle mass decreases with age , leading to " sarcopenia , " or low relative muscle mass , in elderly people . Sarcopenia is believed to be associated with metabolic , physiologic , and functional impairments and disability . Methods of estimating the prevalence of sarcopenia and its associated risks in elderly population s are lacking . Data from a population -based survey of 883 elderly Hispanic and non-Hispanic white men and women living in New Mexico ( the New Mexico Elder Health Survey , 1993 - 1995 ) were analyzed to develop a method for estimating the prevalence of sarcopenia . An anthropometric equation for predicting appendicular skeletal muscle mass was developed from a r and om sub sample ( n = 199 ) of participants and was extended to the total sample . Sarcopenia was defined as appendicular skeletal muscle mass (kg)/height2 ( m2 ) being less than two st and ard deviations below the mean of a young reference group . Prevalences increased from 13 - 24 % in persons under 70 years of age to > 50 % in persons over 80 years of age , and were slightly greater in Hispanics than in non-Hispanic whites . Sarcopenia was significantly associated with self-reported physical disability in both men and women , independent of ethnicity , age , morbidity , obesity , income , and health behaviors . This study provides some of the first estimates of the extent of the public health problem posed by sarcopenia Exercise training improves vascular function in subjects with cardiovascular disease and risk factors , but there is mounting evidence these vascular adaptations may be vessel bed specific . We have therefore examined the hypothesis that exercise-induced improvements in conduit vessel function are related to changes in resistance vessel function . Endothelium-dependent and -independent conduit vessel function were assessed by using wall-tracking of high-resolution brachial artery ultrasound images of the response to flow-mediated dilation ( FMD ) and nitroglycerine [ glyceryl trinitrate ( GTN ) ] administration . Resistance vessel endothelium-dependent and -independent function were assessed using intrabrachial administration of acetylcholine ( ACh ) and nitroprusside ( SNP ) . R and omized crossover studies of 8-wk exercise training were undertaken in untreated hypercholesterolemic ( n = 10 ) , treated hypercholesterolemic ( n = 10 ) , coronary artery disease ( n = 8) , and Type 2 diabetic subjects ( n = 15 ) . Exercise training significantly enhanced responses to ACh ( P < 0.05 ) and FMD ( P < 0.0001 ) . There were no significant changes in either SNP or GTN responses . The correlation between ACh and FMD responses at entry was not significant ( r = 0.186 ; P = 0.231 ) , and training-induced changes in the ACh did not correlate with those in FMD ( r = -0.022 ; P = 0.890 ) . Similarly , no correlation was evident between the SNP and GTN responses at entry ( r = -0.010 ; P = 0.951 ) or between changes in these variables with training ( r = -0.211 ; P = 0.191 ) . We conclude that , although short-term exercise training improves endothelium-dependent nitric oxide-mediated vascular function in both conduit and resistance vessels , the magnitude of these improvements are unrelated BACKGROUND Exercise training improves physical fitness , insulin resistance , and endothelial function in type 2 diabetes . Hypoxia may further optimize these beneficial effects . The aim of this study was to compare the effects of hypoxic versus normoxic exercise training on physical fitness , endothelial function , and insulin resistance in type 2 diabetes . METHODS Peak oxygen consumption , flow mediated dilation ( endothelial function ) , and glucose homeostasis were assessed in 19 patients ( 55±7 years ) before and after an 8-week intervention . Subjects were r and omly allocated to normoxic ( 21 % O2 , n=9 ) or hypoxic ( 16.5 % O2 , n=10 ) exercise training . Endothelium-independent dilation was examined using sublingual administration of glyceryl trinitrate , and used to calculate the ratio between endothelium-dependent and -independent dilation . RESULTS Exercise training improved physical fitness and brachial artery ratio between endothelium-dependent and -independent dilation ( both p<0.05 ) , whilst these exercise training-induced changes were similar in both groups ( interaction-effects p>0.05 ) . Exercise training did not significantly change brachial artery flow-mediated dilation or glyceryl trinitrate-response , superficial femoral artery flow-mediated dilation , or glucose homeostasis , whilst hypoxia did not alter the impact of exercise training . CONCLUSION Contrary to our hypothesis , hypoxia does not potentiate the effect of exercise training on physical fitness , vascular function , or glucose homeostasis in type 2 diabetes OBJECTIVE To investigate the effect of an exercise intervention on flow-mediated dilation ( FMD ) and circulating endothelial biomarkers in adults with type 2 diabetes ( T2DM ) . METHODS Sedentary adults ( n = 140 ) , aged 40 - 65 , with T2DM and untreated pre or Stage I hypertension or treated hypertension were r and omized to a 6-month , supervised , exercise program ( 3 × week ) or a sedentary control . Assessment s included BMI , body and visceral fat , blood pressure , lipids , HbA1c , insulin sensitivity ( QUICKI ) , fitness , FMD , E-selectin , P-selectin , intracellular and vascular cellular adhesion molecules ( ICAM , VCAM ) , and tissue plasminogen activator ( tPA ) . Intervention effects were compared by t-tests . Pearson 's correlations were calculated between changes in cardiovascular risk factors and endothelial outcomes . RESULTS Exercisers significantly improved BMI ( -0.6 kg/m(2 ) ) , body fat % ( -1.4 % ) , HbA1c ( -0.5 % ) , and fitness ( 2.9 mL/kg min ) vs. controls ( p < 0.05 ) . However , there were no differences between groups in changes in FMD , E-selectin , P-selectin , ICAM , VCAM , or tPA . Among exercisers , changes in cardiovascular risk factors correlated with several biomarkers . Decreased P-selectin correlated with decreased BMI ( r = 0.29 , p = 0.04 ) and increased HDL cholesterol ( r = -0.36 , p = 0.01 ) . Decreased ICAM correlated with decreased triglycerides and HbA1c ( r = 0.30 , p = 0.04 ; r = 0.31 , p = 0.03 ) and increased QUICKI ( r = - 0.28 , p = 0.05 ) . Decreased tPA correlated with decreased total body and visceral fat ( r = 0.28 , p = 0.05 ; r = 0.38 , p = 0.008 ) and increased QUICKI ( r = -0.38 , p = 0.007 ) . CONCLUSIONS While exercise result ed in improved fitness , body composition , and glycemic control , there were no changes in FMD or circulating endothelial biomarkers . The associations of changes in cardiovascular risk factors and endothelial biomarkers suggest that improvement in risk factors could mediate the exercise-induced improvements in endothelial function seen in prior studies BACKGROUND AND AIMS Very-low carbohydrate diets can improve glycaemic control in patients with type 2 diabetes ( T2DM ) . However , compared to traditional higher carbohydrate , low fat ( HighCHO ) diets , they have been associated with impaired endothelial function ( measured by flow mediated dilatation [ FMD ] ) that is possibly related to saturated fat . This study aim ed to examine the effects of a 12-month hypocaloric very-low carbohydrate , low saturated fat ( LowCHO ) diet compared to an isocaloric HighCHO diet . METHODS One hundred and fifteen obese patients with T2DM ( age:58.4 ± 0.7 [ SEM ] yr , BMI : 34.6 ± 0.4 kg/m(2 ) , HbA1c:7.33 [ 56.3 mmol/mol ] ± 0.10 % ) were r and omised to consume an energy restricted LowCHO diet ( Carb : Pro : Fat : Sat-Fat 14:28:58 : < 10 % energy ; n = 58 ) or isocaloric HighCHO diet ( 53:17:30 : < 10 % ; n = 57 ) whilst undertaking exercise ( 60 min , 3/wk ) . Bodyweight , HbA1c and FMD were assessed . RESULTS Seventy eight participants completed the intervention ( LowCHO = 41 , HighCHO = 37 ) . Both groups experienced similar reductions in weight and HbA1c ( -10.6 ± 0.7 kg , -1.05 ± 0.10 % ; p < 0.001 time , p ≥ 0.48 time × diet ) . FMD did not change ( p = 0.11 time , p = 0.20 time × diet ) . CONCLUSIONS In patients with obesity and T2DM , HighCHO diet and LowCHO diet have similar effects on endothelial function To determine the effects of continuous aerobic exercise training ( CON ) vs interval aerobic exercise training ( INT ) on glycemic control and endothelium-dependent vasodilatation , 43 participants with type 2 diabetes were r and omly allocated to the sedentary , CON , and INT groups . The CON and INT exercise training programs were design ed to yield the same energy expenditure/exercise session and included walking on treadmill for 30 and 40 min/day , 3 times/week for 12 weeks . Body fatness and heart rate at rest decreased and leg muscle strength increased ( all P < 0.05 ) in both the CON and INT groups . Fasting blood glucose levels decreased ( P < 0.05 ) in both exercise groups but glycosylated hemoglobin levels decreased ( P < 0.05 ) only in the INT group . Maximal aerobic capacity , flow-mediated dilation , and cutaneous reactive hyperemia increased significantly in both exercise groups ; however , the magnitude of improvements was greater in the INT group . Only the INT group experienced reductions in erythrocyte malondialdehyde and serum von Willebr and factor and increases in plasma glutathione peroxidase and nitric oxide ( all P < 0.05 ) . We concluded that both continuous and interval training were effective in improving glycemic control , aerobic fitness , and endothelium-dependent vasodilation , but the interval training program appears to confer greater improvements than the continuous training program AIMS To determine if type 2 diabetes mellitus ( T2D ) differentiates endothelial function and plasma nitrite response ( a marker of nitric oxide bioavailability ) during exercise in peripheral arterial disease ( PAD ) subjects prior to and following 3 months supervised exercise training ( SET ) . METHODS In subjects with T2D+PAD ( n = 13 ) and PAD-only ( n = 14 ) , endothelial function was measured using brachial artery flow-mediated dilation . On a separate day , venous blood draws were performed at rest and 10 min following a symptom-limited grade d treadmill test ( SL-GXT ) . Plasma sample s were snap-frozen for analysis of nitrite by reductive chemiluminescence . All testing was repeated following 3 months of SET . RESULTS Prior to training both groups demonstrated endothelial dysfunction , which was correlated with a net decrease in plasma nitrite following a SL-GXT ( p ≤ 0.05 ) . Following SET , the PAD-only group demonstrated an improvement in endothelial function ( p ≤ 0.05 ) and COT ( p ≤ 0.05 ) , which was related to a net increase in plasma nitrite following the SL-GXT ( both p ≤ 0.05 ) . The T2D+PAD group had none of these increases . CONCLUSIONS T2D in the presence of PAD attenuated improvements in endothelial function , net plasma nitrite , and COT following SET . This suggests that T2D maybe associated with an inability to endogenously increase vascular NO bioavailability to SET Background : Resistance training has been increasingly incorporated into the overall exercise programme because of its effect on muscle strength , functional capacity and osteoporosis . High-intensity resistance training increases arterial stiffness . However , the effect of moderate-intensity resistance training on arterial stiffness is unknown . Objective : To determine whether 12 weeks of moderate-intensity resistance training increases arterial stiffness in middle-aged women . Methods : 35 middle-aged women ( age range 32 to 59 years ) volunteered to participate . The subjects were r and omly assigned to one of three groups : resistance training ( RT ) group , aerobic exercise training ( AET ) group or control group . The RT and AET groups performed 12 weeks of moderate-intensity resistance training or aerobic exercise training ( two days/week ) . Results : In the RT group , one-repetition maximum strength significantly increased after the intervention . Interestingly , aortic ( carotid – femoral ) pulse wave velocity ( PWV ; an index of arterial stiffness ) , and peripheral ( femoral – ankle ) PWV did not change with moderate-intensity resistance training . In contrast , in the AET group , carotid – femoral PWV significantly decreased after the intervention . Resistance training and aerobic exercise training did not affect blood pressure . Conclusions : This study found that moderate-intensity resistance training did not increase arterial stiffness in middle-aged women , which may have great importance for health promotion with resistance training In type 2 diabetes patients , endothelin ( ET ) receptor blockade may enhance blood flow responses to exercise training . The combination of exercise training and ET receptor blockade may represent a more potent stimulus than training alone to improve vascular function , physical fitness and glucose homeostasis . We assessed the effect of an 8 week exercise training programme combined with either ET blockade or placebo on vasculature , fitness and glucose homeostasis in people with type 2 diabetes . In a double-blind r and omized controlled trial , brachial endothelium-dependent and ‑independent dilatation ( using flow-mediated dilatation and glyceryl trinitrate , respectively ) , glucose homeostasis ( using Homeostasis Model Assessment for Insulin Resistance ( HOMA-IR ) ) and physical fitness ( maximal cycling test ) were assessed in 18 men with type 2 diabetes ( 60 ± 6 years old ) . Subjects underwent an 8 week exercise training programme , with half of the subjects receiving ET receptor blockade ( bosentan ) and the other half a placebo , followed by re assessment of the tests above . Exercise training improved physical fitness to a similar extent in both groups , but we did not detect changes in vascular function in either group . This study suggests that there is no adaptation in brachial and femoral artery endothelial function after 8 weeks of training in type 2 diabetes patients . Endothelin receptor blockade combined with exercise training does not additionally alter conduit artery endothelial function or physical fitness in type 2 diabetes AIM The effects of exercise intervention and to assess its long-term efficacy in preventing subsequent cardiovascular events in patients with type 2 diabetes were little known on r and omized controlled trial . METHODS Thirty-eight type 2 diabetic patients ( 21 men and 17 women ) were assigned to either the exercise group ( n=21 ) or the control group without exercise training ( n=17 ) by simple r and omization . The exercise training group was scheduled for aerobic and resistance exercise programs for 3 months . After the 3-month , we investigated endothelial function , insulin resistance , adipocytokines and inflammatory markers . The endothelial function was evaluated by examining a flow-mediated endothelium-dependent vasodilatation ( FMD ) . Furthermore , we followed the incidence of cardiovascular events for 24 months . RESULTS After 3-month , HbA1C was decreased significantly in both groups . FMD was increased from 7.3+/-4.7 % to 10.9+/-6.2 % only in the exercise group ( p<0.05 ) . Long-term follow-up data showed that the control group developed cardiovascular events more frequently than did the exercise group ( p<0.05 ) . CONCLUSIONS Exercise improves endothelial dysfunction independently of glycemic control and insulin sensitivity in patients with type 2 diabetes . The beneficial effects of 3-month exercise to reduce cardiovascular events persist for 24 months OBJECTIVE To investigate and compare the effects of Buddhist walking meditation and traditional walking on glycemic control and vascular function in patients with type 2 diabetes mellitus . METHODS Twenty three patients with type 2 diabetes ( 50 - 75 years ) were r and omly allocated into traditional walking exercise ( WE ; n=11 ) or Buddhism-based walking meditation exercise ( WM ; n=12 ) . Both groups performed a 12-week exercise program that consisted of walking on the treadmill at exercise intensity of 50 - 70 % maximum heart rate for 30min/session , 3 times/week . In the WM training program , the participants performed walking on the treadmill while concentrated on foot stepping by voiced " Budd " and " Dha " with each foot step that contacted the floor to practice mindfulness while walking . RESULTS After 12 weeks , maximal oxygen consumption increased and fasting blood glucose level decreased significantly in both groups ( p<0.05 ) . Significant decrease in HbA1c and both systolic and diastolic blood pressure were observed only in the WM group . Flow-mediated dilatation increased significantly ( p<0.05 ) in both exercise groups but arterial stiffness was improved only in the WM group . Blood cortisol level was reduced ( p<0.05 ) only in the WM group . CONCLUSION Buddhist walking meditation exercise produced a multitude of favorable effects , often superior to traditional walking program , in patients with type 2 diabetes AIM Effects of dietary weight loss on endothelial function , particularly when combined with exercise training , is largely unknown in type 2 diabetes . We sought to determine whether aerobic exercise training provided any additional improvements in endothelial function , oxidative stress or other established markers of cardiovascular risk when combined with an energy-restricted diet in patients with type 2 diabetes . METHODS In a parallel study design , 29 sedentary , overweight and obese patients with type 2 diabetes ( age 52.4 + /- 1.4 years and BMI 34.2 + /- 0.9 kg/m(2 ) ) were r and omized to a 12-week moderate energy-restricted diet ( ~5000 kJ/day and approximately 30 % energy deficit ) with or without aerobic exercise training [ diet only ( D ) , n = 16 and diet plus exercise ( DE ) , n = 13 ] . Body weight , cardiovascular risk markers , malondialdehyde ( MDA , oxidative stress marker ) , 24-h urinary nitrate/nitrite and flow-mediated dilatation ( FMD ) of the brachial artery were measured pre- and postintervention . RESULTS Both interventions reduced body weight ( D 8.9 % , DE 8.5 % , time effect p < 0.001 ) . Significant reductions in body fat , waist circumference , blood pressure , glycated haemoglobin , glucose , insulin resistance , lipids and MDA and increases in urinary nitrite/nitrate were observed in both groups ( time effect p < or = 0.05 ) ; however , these changes were not different between treatments . At baseline , FMD was similar in both groups ( D 2.5 + /- 0.9 % , DE 4.2 + /- 1.2 % ; p = 0.25 ) and did not change after the interventions ( p = 0.59 ) . CONCLUSIONS These results suggest that lifestyle interventions incorporating diet with or without exercise improve glycaemic control , reduce oxidative stress and improve other cardiovascular risk factors but do not improve FMD in obese subjects with type 2 diabetes We have pooled data from a series of our exercise training studies undertaken in groups with a broad range of vascular ( dys ) function to the examine the hypothesis that exercise-induced improvements in the conduit and /or resistance vessel function are related to improvements in risk factors for cardiovascular ( CV ) disease . Endothelium-dependent and -independent conduit vessel function were assessed by using wall tracking of high-resolution ultrasound images of the brachial artery response to flow-mediated dilation ( FMD ) and glyceryl trinitrate . Resistance vessel function was assessed using intrabrachial administration of acetylcholine ( ACh ) , sodium nitroprusside , and NG-monomethyl-l-arginine . R and omized cross-over studies of 8-wk exercise training were undertaken in untreated hypercholesterolemic ( n = 11 ) , treated hypercholesterolemic ( n = 11 ) , coronary artery disease ( n = 10 ) , chronic heart failure ( n = 12 ) , Type 2 diabetic ( n = 15 ) , and healthy control subjects ( n = 16 ) . Exercise training did not significantly alter plasma lipids , blood pressure , blood glucose , waist-to-hip ratio , or body mass index values , despite significant improvement in both FMD and ACh responses . There were no correlations between changes in any risk factor variables and indexes of either resistance or conduit vessel function . We conclude that , in these subjects with antecedent vascular dysfunction , the beneficial effects of relatively short-term exercise training on vascular function are not solely mediated by the effects of exercise on CV risk factors OBJECTIVES The purpose of this study was to examine whether exercise training stimulates a generalized improvement in vascular function in patients with type 2 diabetes mellitus . BACKGROUND Exercise is often recommended for patients with type 2 diabetes to improve physical conditioning and glycemic control . This study examined the effect of eight weeks of exercise training on conduit and resistance vessel function in patients with type 2 diabetes , using a r and omized crossover design . METHODS Both resistance vessel endothelium-dependent and -independent functions were determined by forearm plethysmography and intrabrachial infusions of acetylcholine ( ACh ) and sodium nitroprusside ( SNP ) , respectively , in 16 patients with type 2 diabetes . Conduit vessel endothelial function was assessed in 15 of these patients using high-resolution ultrasound and flow-mediated dilation of the brachial artery ; glyceryl trinitrate ( GTN ) was used as an endothelium-independent dilator . RESULTS Flow-mediated dilation increased from 1.7 + /- 0.5 % to 5.0 + /- 0.4 % following training ( p < 0.001 ) . The forearm blood flow ratio to ACh was significantly improved ( analysis of variance , p < 0.05 ) . Responses to SNP and GTN were unchanged . Endothelium-dependent vasodilation was enhanced in both conduit and resistance vessels . CONCLUSIONS If endothelial dysfunction is an integral component of the pathogenesis of vascular disease , as currently believed , this study supports the value of an exercise program in the management of type 2 diabetes Microvascular and macrovascular dysfunction plays an important role in the pathogenesis of diabetic vascular disease . Twenty-nine older patients with type 2 diabetes were r and omly assigned into the l and -based ( LB ; n = 14 ) or water-based ( WB ; n = 15 ) groups . Both groups completed supervised aerobic cycling exercises three times per week for 12 weeks . The WB group performed cycling exercise training in warm water ( 36 ° C ) immersed to the hip level . After 12 weeks , blood glucose concentration and insulin resistance did not change but hemoglobin A1c levels decreased ( P < .05 ) in both groups . Plasma nitric oxide concentrations increased ( P < .05 ) in both groups . Flow-mediated dilation in the popliteal artery increased and arterial stiffness decreased ( P < .05 ) in both exercise groups . Indices of microvascular reactivity improved ( P < .05 ) only in the WB group . The benefits of warm water-based training were similar in general , and superior in some measures , to the more established l and -based cycling exercise Background Exercise is recommended for people with diabetes , but little is known about exercise in people with diabetic peripheral neuropathy ( DPN ) . Objective The primary purpose of this preliminary study was to examine adverse events ( AEs ) during moderate-intensity , supervised aerobic exercise in people with DPN . The secondary purpose was to examine changes in fatigue , aerobic fitness , and other outcomes after intervention . Design This was a single-group preliminary study . Setting The setting was an academic medical center . Participants Participants were 18 people who were sedentary and had type 2 diabetes and peripheral neuropathy ( mean age=58.1 years , SD=5 ) . Intervention The intervention was a supervised 16-week aerobic exercise program ( 3 times per week at 50 % to > 70 % oxygen uptake reserve ) . Measurements Adverse events were categorized as related or unrelated to the study , anticipated or unanticipated , and serious or not serious . Outcomes included fatigue ( Multidimensional Fatigue Inventory ) , cardiovascular fitness ( peak oxygen uptake ) , body composition ( dual-energy x-ray absorptiometry ) , sleep quality , plasma metabolic markers , and peripheral vascular function . Results During the study , 57 nonserious AEs occurred . Improvements were found in general fatigue ( mean change=−3.5 ; 95 % confidence interval [ 95 % CI]=−1.3 , −5.3 ) , physical fatigue ( mean change=−3.1 ; 95 % CI=−1.2 , −5.0 ) , peak oxygen uptake ( mean change=1.1 mL·kg−1·min−1 ; 95 % CI=0.2 , 1.9 ) , total body fat ( mean change=−1 % ; 95 % CI=−0.3 , −1.7 ) , fat mass ( mean change=−1,780 g ; 95 % CI=−616.2 , −2,938.7 ) , and peripheral blood flow ( mean change=2.27 % ; 95 % CI=0.6 , 4.0 ) . Limitations This was a small-scale , uncontrolled study . A future r and omized controlled trial is needed to fully assess the effects of exercise on the outcomes . Conclusions This study provides new support for supervised aerobic exercise in people with DPN . However , it is important for physical therapists to carefully prescribe initial exercise intensity and provide close monitoring and education to address the anticipated AEs as people who are sedentary and have DPN begin an exercise program |
1,364 | 29,603,132 | Breast surgery performed after NAT does not reflect tumour response , result ing in potentially unnecessary radical surgery , especially mastectomy . | BACKGROUND Neoadjuvant therapy ( NAT ) for operable breast cancer may facilitate more breast-conserving surgery ( BCS ) .
It seems , however , that this benefit is not being realized fully . | BACKGROUND We studied the effect on tumour response to neoadjuvant therapy of the substitution of lapatinib for trastuzumab in combination with weekly paclitaxel after doxorubicin plus cyclophosphamide treatment , and of the addition of lapatinib and trastuzumab combined after doxorubicin plus cyclophosphamide treatment in patients with HER2-positive operable breast cancer to determine whether there would be a benefit of dual HER2 blockade in these patients . METHODS For this open-label , r and omised phase 3 trial we recruited women aged 18 years or older with an ECOG performance status of 0 or 1 with operable HER2-positive breast cancer . Each received four cycles of st and ard doxorubicin 60 mg/m(2 ) and cyclophosphamide 600 mg/m(2 ) intravenously on day 1 every 3 weeks followed by four cycles of weekly paclitaxel ( 80 mg/m(2 ) ) intravenously on days 1 , 8 , and 15 , every 4 weeks . Concurrently with weekly paclitaxel , patients received either trastuzumab ( 4 mg/kg load , then 2 mg/kg intravenously ) weekly until surgery , lapatinib ( 1250 mg orally ) daily until surgery , or weekly trastuzumab plus lapatinib ( 750 mg orally ) daily until surgery . After surgery , all patients received trastuzumab to complete 52 weeks of HER2-targeted therapy . R and omisation ( ratio 1:1:1 ) was done central ly with stratification by clinical tumour size , clinical nodal status , hormone-receptor status , and age . The primary endpoint was the pathological complete response in the breast , and analysis was performed on an intention-to-treat population . FINDINGS Patient accrual started on July 16 , 2007 , and was completed on June 30 , 2011 ; 529 women were enrolled in the trial . 519 patients had their pathological response determined . Breast pathological complete response was noted in 93 ( 52·5 % , 95 % CI 44·9 - 59·5 ) of 177 patients in the trastuzumab group , 91 ( 53·2 % , 45·4 - 60·3 ) of 171 patients in the lapatinib group ( p=0·9852 ) ; and 106 ( 62·0 % , 54·3 - 68·8 ) of 171 patients in the combination group ( p=0·095 ) . The most common grade 3 and 4 toxic effects were neutropenia ( 29 [ 16 % ] patients in the trastuzumab group [ grade 4 in five patients ( 3 % ) , 28 [ 16 % ] in the lapatinib group [ grade 4 in eight patients ( 5 % ) ] , and 29 [ 17 % ] in the combination group [ grade 4 in nine patients ( 5 % ) ] ) and grade 3 diarrhoea ( four [ 2 % ] patients in the trastuzumab group , 35 [ 20 % ] in the lapatinib group , and 46 [ 27 % ] in the combination group ; p<0·0001 ) . Symptomatic congestive heart failure defined as New York Heart Association Class III or IV events occurred in seven ( 4 % ) patients in the trastuzumab group , seven ( 4 % ) in the lapatinib group , and one ( < 1 % ) in the combination group ; p=0·185 ) . INTERPRETATION Substitution of lapatinib for trastuzumab in combination with chemotherapy result ed in similar high percentages of pathological complete response . Combined HER2-targeted therapy produced a numerically but insignificantly higher pathological complete response percentage than single-agent HER2-directed therapy ; these findings are consistent with results from other studies . Trials are being undertaken to further assess these findings in the adjuvant setting BACKGROUND In metastatic breast cancer , nab-paclitaxel has been shown to significantly increase progression-free survival compared with solvent-based paclitaxel . The GeparSepto ( GBG 69 ) trial assessed whether weekly nab-paclitaxel could increase the proportion of patients achieving pathological complete response compared with weekly solvent-based paclitaxel , both followed by epirubicin plus cyclophosphamide as neoadjuvant treatment . METHOD In a phase 3 r and omised trial , we enrolled patients with previously untreated unilateral or bilateral primary invasive breast cancer and r and omly assigned them in a 1:1 ratio using dynamic allocation and Pocock minimisation by breast cancer subtype , Ki67 and SPARC expression . Patients were treated for 12 weeks with either intravenous nab-paclitaxel 150 mg/m(2 ) ( after study amendment , 125 mg/m(2 ) ) on days 1 , 8 , and 15 for four 3-week cycles , or solvent-based intravenous paclitaxel 80 mg/m(2 ) on days 1 , 8 , and 15 for four 3-week cycles . Taxane treatment was followed in both groups by intravenous epirubicin 90 mg/m(2 ) plus intravenous cyclophosphamide 600 mg/m(2 ) on day 1 for four 3-week cycles . Patients with HER2-positive tumours received concurrent trastuzumab 6 mg/kg ( loading dose 8 mg/kg ) and pertuzumab 420 mg ( loading dose 840 mg ) on day 1 of every 3-week cycle . Trastuzumab and pertuzumab were given every 3 weeks concomitantly with chemotherapy for all cycles . This report is the final analysis of the primary endpoint , pathological complete response ( ypT0 ypN0 ) , analysed for all patients who started treatment ( modified intention to treat ) . We used a closed test procedure to test for non-inferiority , with the nab-paclitaxel group calculated as non-inferior to the solvent-based paclitaxel group if the lower 95 % CI for the OR was above 0·858 ( OR equivalent to pathological complete response [ 33 % ] minus a 10 % non-inferiority margin [ 3·3 % ] ; 29·7 % ) . We planned to test for superiority only in case of a positive non-inferiority test , using an α of 0·05 . Safety was assessed in all patients who received study drug . The trial is registered with Clinical Trials.gov , number NCT01583426 . FINDINGS Between July 30 , 2012 , and Dec 23 , 2013 , we r and omly assigned 1229 women , of whom 1206 started treatment ( 606 with nab-paclitaxel and 600 with solvent-based paclitaxel ) . The nab-paclitaxel dose was reduced after enrolment of 464 participants to 125 mg/m(2 ) due to increased treatment discontinuation and sensory neuropathy in this group . Pathological complete response occurred more frequently in the nab-paclitaxel group ( 233 [ 38 % , 95 % CI 35 - 42 ] patients ) than in the solvent-based paclitaxel group ( 174 [ 29 % , 25 - 33 ] patients ; OR 1·53 , 95 % CI 1·20 - 1·95 ; unadjusted p=0·00065 ) . The incidence of grade 3 - 4 anaemia ( 13 [ 2 % ] of 605 patients in the nab-paclitaxel group vs four [ 1 % ] of patients in the solvent-based paclitaxel group ; p=0·048 ) and peripheral sensory neuropathy grade 3 - 4 ( 63 [ 10 % ] patients receiving any nab-paclitaxel dose ; 31 [ 8 % ] of patients starting with 125 mg/m(2 ) and 32 [ 15 % ] of patients starting with 150 mg/m(2 ) ; vs 16 [ 3 % ] in the solvent-based paclitaxel group , p<0·001 ) was significantly higher for nab-paclitaxel than for solvent-based paclitaxel . Overall , 283 ( 23 % ) patients were noted to have at least one serious adverse event ( based on study drug received ) , 156 ( 26 % ) in the nab-paclitaxel group and 127 ( 21 % ) in the solvent-based paclitaxel group ( p=0·057 ) . There were three deaths ( during epirubicin plus cyclophosphamide treatment ) in the nab-paclitaxel group ( due to sepsis , diarrhoea , and accident unrelated to the trial ) versus one in the solvent-based paclitaxel group ( during paclitaxel treatment ; cardiac failure ) . INTERPRETATION Substituting solvent-based paclitaxel with nab-paclitaxel significantly increases the proportion of patients achieving a pathological complete response rate after anthracycline-based chemotherapy . These results might lead to an exchange of the preferred taxane , solvent-based paclitaxel , for nab-paclitaxel in therapy for primary breast cancer . FUNDING Celgene , Roche BACKGROUND Pertuzumab ( P ) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer . We assessed the tolerability , with particular focus on cardiac safety , of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer . PATIENTS AND METHODS In this multicenter , open-label phase II study , patients with operable , locally advanced , or inflammatory breast cancer were r and omized 1 : 1 : 1 to receive six neoadjuvant cycles q3w ( Arm A : 5-fluorouracil , epirubicin , cyclophosphamide [ FEC ] + H + P ×3 → docetaxel [ T ] + H + P ×3 ; Arm B : FEC ×3 → T + H + P ×3 ; Arm C : T + carboplatin + H [TCH]+P ×6 ) . pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H. RESULTS Two hundred twenty-five patients were r and omized . During neoadjuvant treatment , two patients ( 2.7 % ; Arm B ) experienced symptomatic left ventricular systolic dysfunction ( LVSD ) and 11 patients ( Arm A : 4 [ 5.6 % ] ; Arm B : 4 [ 5.3 % ] ; Arm C : 3 [ 3.9 % ] ) had declines in left ventricular ejection fraction of ≥10 % points from baseline to < 50 % . Diarrhea was the most common adverse event . pCR ( ypT0/is ) was reported for 61.6 % ( Arm A ) , 57.3 % ( Arm B ) , and 66.2 % ( Arm C ) of patients . CONCLUSION The combination of P with H and st and ard chemotherapy result ed in low rates of symptomatic LVSD BACKGROUND If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node , axillary lymph node dissection is the present st and ard . Although axillary lymph node dissection provides excellent regional control , it is associated with harmful side-effects . We aim ed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects . METHODS Patients with T1 - 2 primary breast cancer and no palpable lymphadenopathy were enrolled in the r and omised , multicentre , open-label , phase 3 non-inferiority EORTC 10981 - 22023 AMAROS trial . Patients were r and omly assigned ( 1:1 ) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node , stratified by institution . The primary endpoint was non-inferiority of 5-year axillary recurrence , considered to be not more than 4 % for the axillary radiotherapy group compared with an expected 2 % in the axillary lymph node dissection group . Analyses were by intention to treat and per protocol . The AMAROS trial is registered with Clinical Trials.gov , number NCT00014612 . FINDINGS Between Feb 19 , 2001 , and April 29 , 2010 , 4823 patients were enrolled at 34 centres from nine European countries , of whom 4806 were eligible for r and omisation . 2402 patients were r and omly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy . Of the 1425 patients with a positive sentinel node , 744 had been r and omly assigned to axillary lymph node dissection and 681 to axillary radiotherapy ; these patients constituted the intention-to-treat population . Median follow-up was 6·1 years ( IQR 4·1 - 8·0 ) for the patients with positive sentinel lymph nodes . In the axillary lymph node dissection group , 220 ( 33 % ) of 672 patients who underwent axillary lymph node dissection had additional positive nodes . Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group . 5-year axillary recurrence was 0·43 % ( 95 % CI 0·00 - 0·92 ) after axillary lymph node dissection versus 1·19 % ( 0·31 - 2·08 ) after axillary radiotherapy . The planned non-inferiority test was underpowered because of the low number of events . The one-sided 95 % CI for the underpowered non-inferiority test on the hazard ratio was 0·00 - 5·27 , with a non-inferiority margin of 2 . Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year , 3 years , and 5 years . INTERPRETATION Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1 - 2 primary breast cancer and no palpable lymphadenopathy . Axillary radiotherapy results in significantly less morbidity . FUNDING EORTC Charitable Trust BACKGROUND Neoadjuvant hormonal therapy ( NHT ) is playing an increasing role in the clinical management of breast cancer ( BC ) and may improve surgical outcomes for postmenopausal , oestrogen receptor (ER)-positive BC patients . However , there is currently no consensus on the optimal duration of NHT before surgery . Here , we present the outcomes of the TEAM IIA trial , a multicentre , phase II trial investigating the efficacy of six months of neoadjuvant exemestane in postmenopausal , strong ER-positive ( ER+ , ⩾50 % ) BC patients . METHODS 102 patients ( stage T2-T4ac ) were included in the study after exclusion of ineligible patients . Primary end-point was clinical response at 3 and 6 months as measured by palpation . Secondary end-point was radiological response as measured by magnetic resonance imaging ( MRI ) , mammography and /or ultrasound . Linear mixed models ( 95 % confidence interval ( CI ) ) were used to compare changes in mean tumour size ( in mm ) between baseline , 3 and 6 months after the start of endocrine therapy . Conversion rates from mastectomy to breast conserving surgery ( BCS ) were evaluated . RESULTS Median age of all patients was 72 years ( range 53 - 88 ) . Overall response rate by clinical palpation was 64.5 % in all patients with a final palpation measurement . Four patients had clinical ly progressive disease . 63 patients had both 3-month and > 3-month palpation measurements . Overall response was 58.7 % at 3 months and 68.3 % at final palpation ( > 3 months ) . Mean tumour size by clinical palpation at T=0 was 39.1 mm ( 95 % CI 34.8 - 43.4 mm ) , and decreased to 23.0 mm ( 95 % CI 18.7 - 27.2 mm ) and 16.7 mm ( 95 % CI 12.6 - 20.8 ) at T=3 and T>3 months , respectively ( p=0.001 ) . Final radiological response rates at the end of treatment for MRI ( n=37 ) , ultrasound ( n=77 ) and mammography ( n=56 ) were 70.3 % , 41.6 % and 48.2 % , respectively . Feasibility of BCS improved from 61.8 % to 70.6 % ( McNemar p=0.012 ) . CONCLUSION 6 months of neoadjuvant exemestane therapy helps reduce mean tumour size further in strongly ER-positive BC patients without significant side-effects compared to 3 months . Nevertheless , some patients still experience disease progression under exemestane . Feasibility of breast conservation rates improved by almost 10 % The omission of axillary lymph node dissection ( ALND ) in patients with breast cancer with a negative finding on sentinel node biopsy ( SNB ) has reduced arm morbidity substantially . Early follow‐up reports have shown the rate of axillary recurrence to be significantly lower than expected , with a median false‐negative rate of 7 per cent for SNB . Long‐term follow‐up is needed as recurrences may develop late BACKGROUND The optimum timing of sentinel-lymph-node biopsy for breast cancer patients treated with neoadjuvant chemotherapy is uncertain . The SENTINA ( SENTinel NeoAdjuvant ) study was design ed to evaluate a specific algorithm for timing of a st and ardised sentinel-lymph-node biopsy procedure in patients who undergo neoadjuvant chemotherapy . METHODS SENTINA is a four-arm , prospect i ve , multicentre cohort study undertaken at 103 institutions in Germany and Austria . Women with breast cancer who were scheduled for neoadjuvant chemotherapy were enrolled into the study . Patients with clinical ly node-negative disease ( cN0 ) underwent sentinel-lymph-node biopsy before neoadjuvant chemotherapy ( arm A ) . If the sentinel node was positive ( pN1 ) , a second sentinel-lymph-node biopsy procedure was done after neoadjuvant chemotherapy ( arm B ) . Women with clinical ly node-positive disease ( cN+ ) received neoadjuvant chemotherapy . Those who converted to clinical ly node-negative disease after chemotherapy ( ycN0 ; arm C ) were treated with sentinel-lymph-node biopsy and axillary dissection . Only patients whose clinical nodal status remained positive ( ycN1 ) underwent axillary dissection without sentinel-lymph-node biopsy ( arm D ) . The primary endpoint was accuracy ( false-negative rate ) of sentinel-lymph-node biopsy after neoadjuvant chemotherapy for patients who converted from cN1 to ycN0 disease during neoadjuvant chemotherapy ( arm C ) . Secondary endpoints included comparison of the detection rate of sentinel-lymph-node biopsy before and after neoadjuvant chemotherapy , and also the false-negative rate and detection rate of sentinel-lymph-node biopsy after removal of the sentinel lymph node . Analyses were done according to treatment received ( per protocol ) . FINDINGS Of 1737 patients who received treatment , 1022 women underwent sentinel-lymph-node biopsy before neoadjuvant chemotherapy ( arms A and B ) , with a detection rate of 99.1 % ( 95 % CI 98.3 - 99.6 ; 1013 of 1022 ) . In patients who converted after neoadjuvant chemotherapy from cN+ to ycN0 ( arm C ) , the detection rate was 80.1 % ( 95 % CI 76.6 - 83.2 ; 474 of 592 ) and false-negative rate was 14.2 % ( 95 % CI 9.9 - 19.4 ; 32 of 226 ) . The false-negative rate was 24.3 % ( 17 of 70 ) for women who had one node removed and 18.5 % ( 10 of 54 ) for those who had two sentinel nodes removed ( arm C ) . In patients who had a second sentinel-lymph-node biopsy procedure after neoadjuvant chemotherapy ( arm B ) , the detection rate was 60.8 % ( 95 % CI 55.6 - 65.9 ; 219 of 360 ) and the false-negative rate was 51.6 % ( 95 % CI 38.7 - 64.2 ; 33 of 64 ) . INTERPRETATION Sentinel-lymph-node biopsy is a reliable diagnostic method before neoadjuvant chemotherapy . After systemic treatment or early sentinel-lymph-node biopsy , the procedure has a lower detection rate and a higher false-negative rate compared with sentinel-lymph-node biopsy done before neoadjuvant chemotherapy . These limitations should be considered if biopsy is planned after neoadjuvant chemotherapy . FUNDING Brustkrebs Deutschl and , German Society for Senology , German Breast Group PURPOSE To determine , in women with primary operable breast cancer , if preoperative doxorubicin ( Adriamycin ) and cyclophosphamide ( Cytoxan ; AC ) therapy yields a better outcome than postoperative AC therapy , if a relationship exists between outcome and tumor response to preoperative chemotherapy , and if such therapy results in the performance of more lumpectomies . PATIENTS AND METHODS Women ( 1,523 ) enrolled onto National Surgical Adjuvant Breast and Bowel Project ( NSABP ) B-18 were r and omly assigned to preoperative or postoperative AC therapy . Clinical tumor response to preoperative therapy was grade d as complete ( cCR ) , partial ( cPR ) , or no response ( cNR ) . Tumors with a cCR were further categorized as either pathologic complete response ( pCR ) or invasive cells ( pINV ) . Disease-free survival ( DFS ) , distant disease-free survival ( DDFS ) , and survival were estimated through 5 years and compared between treatment groups . In the preoperative arm , proportional-hazards models were used to investigate the relationship between outcome and tumor response . RESULTS There was no significant difference in DFS , DDFS , or survival ( P = .99 , .70 , and .83 , respectively ) among patients in either group . More patients treated preoperatively than postoperatively underwent lumpectomy and radiation therapy ( 67.8 % v 59.8 % , respectively ) . Rates of ipsilateral breast tumor recurrence ( IBTR ) after lumpectomy were similar in both groups ( 7.9 % and 5.8 % , respectively ; P = .23 ) . Outcome was better in women whose tumors showed a pCR than in those with a pINV , cPR , or cNR ( relapse-free survival [ RFS ] rates , 85.7 % , 76.9 % , 68.1 % , and 63.9 % , respectively ; P < .0001 ) , even when baseline prognostic variables were controlled . When prognostic models were compared for each treatment group , the preoperative model , which included breast tumor response as a variable , discriminated outcome among patients to about the same degree as the postoperative model . CONCLUSION Preoperative chemotherapy is as effective as postoperative chemotherapy , permits more lumpectomies , is appropriate for the treatment of certain patients with stages I and II disease , and can be used to study breast cancer biology . Tumor response to preoperative chemotherapy correlates with outcome and could be a surrogate for evaluating the effect of chemotherapy on micrometastases ; however , knowledge of such a response provided little prognostic information beyond that which result ed from postoperative therapy Abstract Background The impact of tumor focality on type of surgery , local recurrence rate , and survival after neoadjuvant chemotherapy ( NACT ) for breast cancer is not fully understood . This study aim ed to compare local recurrence-free survival ( LRFS ) , disease-free survival ( DFS ) , and overall survival ( OS ) according to focality stratified by type of surgery and pathologic complete response ( pCR ) , with a focus on breast conservation . Methods Participants ( n = 6,134 ) in the GeparTrio , GeparQuattro , and GeparQuinto trials with operable or locally advanced tumors receiving NACT were classified as having unifocal ( 1 lesion ) , multifocal ( ≥2 lesions in 1 quadrant ) , or multicentric ( ≥1 lesion in ≥2 quadrants ) disease . The study investigated LRFS , DFS , and OS according to focality stratified by type of surgery and pathologic complete response . Results The patients were classified as having unifocal ( n = 4,733 , 77.1 % ) , multifocal ( n = 820 , 13.4 % ) , or multicentric ( n = 581 , 9.5 % ) tumors . The respective pCR rates were 19.4 , 16.5 , and 14.4 % . Breast conservation was performed for 71.6 , 58.5 , and 30 % of these patients , respectively ( P < 0.001 ) . The LRFS rate was 92.9 % for the unifocal , 95.1 % for the multifocal , and 90.4 % for the multicentric tumors ( P = 0.002 ) . The patients with multicentric tumors but not the patients with multifocal tumors had worse DFS ( P < 0.001 ) and OS ( P = 0.009 ) than the patients with unifocal tumors . However , LRFS , DFS , and OS were not inferior for the patients with multicentric or multifocal tumors if pCR was achieved or breast conservation was performed after NACT . Conclusion Breast conservation is feasible for clinical ly multifocal or multicentric breast cancer patients who undergo NACT without worsening LRFS if tumor-free margins can be attained or if patients achieve a pCR PURPOSE One third of patients with triple-negative breast cancer ( TNBC ) achieve pathologic complete response ( pCR ) with st and ard neoadjuvant chemotherapy ( NACT ) . CALGB 40603 ( Alliance ) , a 2 × 2 factorial , open-label , r and omized phase II trial , evaluated the impact of adding carboplatin and /or bevacizumab . PATIENTS AND METHODS Patients ( N = 443 ) with stage II to III TNBC received paclitaxel 80 mg/m(2 ) once per week ( wP ) for 12 weeks , followed by doxorubicin plus cyclophosphamide once every 2 weeks ( ddAC ) for four cycles , and were r and omly assigned to concurrent carboplatin ( area under curve 6 ) once every 3 weeks for four cycles and /or bevacizumab 10 mg/kg once every 2 weeks for nine cycles . Effects of adding these agents on pCR breast ( ypT0/is ) , pCR breast/axilla ( ypT0/isN0 ) , treatment delivery , and toxicities were analyzed . RESULTS Patients assigned to either carboplatin or bevacizumab were less likely to complete wP and ddAC without skipped doses , dose modification , or early discontinuation result ing from toxicity . Grade ≥ 3 neutropenia and thrombocytopenia were more common with carboplatin , as were hypertension , infection , thromboembolic events , bleeding , and postoperative complications with bevacizumab . Employing one-sided P values , addition of either carboplatin ( 60 % v 44 % ; P = .0018 ) or bevacizumab ( 59 % v 48 % ; P = .0089 ) significantly increased pCR breast , whereas only carboplatin ( 54 % v 41 % ; P = .0029 ) significantly raised pCR breast/axilla . More-than-additive interactions between the two agents could not be demonstrated . CONCLUSION In stage II to III TNBC , addition of either carboplatin or bevacizumab to NACT increased pCR rates , but whether this will improve relapse-free or overall survival is unknown . Given results from recently reported adjuvant trials , further investigation of bevacizumab in this setting is unlikely , but the role of carboplatin could be evaluated in definitive studies , ideally limited to biologically defined patient subsets most likely to benefit from this agent PURPOSE The Immediate Preoperative Anastrozole , Tamoxifen , or Combined With Tamoxifen ( IMPACT ) trial was design ed to test the hypothesis that the clinical and /or biologic effects of neoadjuvant tamoxifen compared with anastrozole and with the combination of tamoxifen and anastrozole before surgery in postmenopausal women with estrogen receptor ( ER ) -positive , invasive , nonmetastatic breast cancer might predict for outcome in the Arimidex , Tamoxifen Alone or in Combination ( ATAC ) adjuvant therapy trial . PATIENTS AND METHODS Postmenopausal women with ER-positive , invasive , nonmetastatic , and operable or locally advanced potentially operable breast cancer were r and omly assigned to neoadjuvant tamoxifen ( 20 mg daily ) , anastrozole ( 1 mg daily ) , or a combination of tamoxifen and anastrozole for 3 months . The tumor objective response ( OR ) was assessed by both caliper and ultrasound . Comparisons were also made of clinical response with ultrasound response , actual and feasible surgery with feasible surgery at baseline , OR in human epidermal growth factor receptor 2 (HER2)-positive cancers , and tolerability . RESULTS There were no significant differences in OR in the intent-to-treat population between patients receiving tamoxifen , anastrozole , or the combination . In patients who were assessed as requiring mastectomy at baseline ( n = 124 ) , 44 % of patients received breast-conserving surgery ( BCS ) after anastrozole compared with 31 % of patients after tamoxifen ( P = .23 ) ; this difference became significant for patients who were deemed feasible for BCS by their surgeon ( 46 % v 22 % , respectively ; P = .03 ) . The OR for patients with HER2-positive cancer ( n = 34 ) was 58 % for anastrozole compared with 22 % for tamoxifen ( P = .18 ) . All treatments were well tolerated . CONCLUSION Neoadjuvant anastrozole is as effective and well tolerated as tamoxifen in ER-positive operable breast cancer in postmenopausal women , but the hypothesis that clinical outcome might predict for long-term outcome in adjuvant therapy was not fulfilled OBJECTIVE To assess the efficacy of neoadjuvant systemic therapy ( NST ) at increasing the rate of successful breast-conserving therapy ( BCT ) in triple negative breast cancer . BACKGROUND Inducing tumor regression to permit BCT is often cited to support administration of NST . To quantify this benefit , we conducted a surgical companion study to CALGB40603 , a r and omized phase II , 2 × 2 factorial trial of neoadjuvant paclitaxel ± carboplatin ± bevacizumab ( B ) followed by doxorubicin plus cyclophosphamide ± B in stage II-III triple negative breast cancer . METHODS Before and after NST , treating surgeons evaluated BCT c and idacy by clinico-radiographic criteria ; surgery performed was at surgeon and patient discretion . We measured ( 1 ) conversion rates from BCT-ineligible to BCT-eligible , ( 2 ) surgical choices in BCT c and i date s , and ( 3 ) rates of successful BCT with tumor-free margins . RESULTS Four hundred four patients were assessable for surgical outcomes . Two hundred nineteen ( 54 % ) were BCT c and i date s before NST . One hundred ninety-seven ( 90 % ) remained BCT c and i date s after NST , of whom 138 ( 70 % ) chose BCT , which was successful in 130 ( 94 % ) . Of 185 ( 46 % ) who were not BCT c and i date s before NST , 78 ( 42 % ) converted to c and i date s with NST . Of these , 53 ( 68 % ) chose BCT with a 91 % ( 48/53 ) success rate . The overall BCT- eligibility rate rose from 54 % to 68 % ( 275/404 ) with NST . Addition of carboplatin , B , or both increased conversion rates . CONCLUSIONS This is the first study to document prospect ively a 42 % conversion rate from BCT-ineligible to BCT-eligible , result ing in a 14 % absolute increase in BCT eligibility . BCT was successful in 93 % of patients who opted for it , but 31 % of BCT-eligible patients still chose mastectomy PURPOSE The exact definition of pathologic complete response ( pCR ) and its prognostic impact on survival in intrinsic breast cancer subtypes is uncertain . METHODS Tumor response at surgery and its association with long-term outcome of 6,377 patients with primary breast cancer receiving neoadjuvant anthracycline-taxane-based chemotherapy in seven r and omized trials were analyzed . RESULTS Disease-free survival ( DFS ) was significantly superior in patients with no invasive and no in situ residuals in breast or nodes ( n = 955 ) compared with patients with residual ductal carcinoma in situ only ( n = 309 ) , no invasive residuals in breast but involved nodes ( n = 186 ) , only focal-invasive disease in the breast ( n = 478 ) , and gross invasive residual disease ( n = 4,449 ; P < .001 ) . Hazard ratios for DFS comparing patients with or without pCR were lowest when defined as no invasive and no in situ residuals ( 0.446 ) and increased monotonously when in situ residuals ( 0.523 ) , no invasive breast residuals but involved nodes ( 0.623 ) , and focal-invasive disease ( 0.727 ) were included in the definition . pCR was associated with improved DFS in luminal B/human epidermal growth factor receptor 2 ( HER2 ) -negative ( P = .005 ) , HER2-positive/nonluminal ( P < .001 ) , and triple-negative ( P < .001 ) tumors but not in luminal A ( P = .39 ) or luminal B/HER2-positive ( P = .45 ) breast cancer . pCR in HER2-positive ( nonluminal ) and triple-negative tumors was associated with excellent prognosis . CONCLUSION pCR defined as no invasive and no in situ residuals in breast and nodes can best discriminate between patients with favorable and unfavorable outcomes . Patients with noninvasive or focal-invasive residues or involved lymph nodes should not be considered as having achieved pCR . pCR is a suitable surrogate end point for patients with luminal B/HER2-negative , HER2-positive ( nonluminal ) , and triple-negative disease but not for those with luminal B/HER2-positive or luminal A tumors PURPOSE Placing clips in nodes with biopsy-confirmed metastasis before initiating neoadjuvant therapy allows for evaluation of response in breast cancer . Our goal was to determine if pathologic changes in clipped nodes reflect the status of the nodal basin and if targeted axillary dissection ( TAD ) , which includes sentinel lymph node dissection ( SLND ) and selective localization and removal of clipped nodes , improves the false-negative rate ( FNR ) compared with SLND alone . METHODS A prospect i ve study of patients with biopsy-confirmed nodal metastases with a clip placed in the sample d node was performed . After neoadjuvant therapy , patients underwent axillary surgery and the pathology of the clipped node was compared with other nodes . Patients undergoing TAD had SLND and selective removal of the clipped node using iodine-125 seed localization . The FNR was determined in patients undergoing complete axillary lymphadenectomy ( ALND ) . RESULTS Of 208 patients enrolled in this study , 191 underwent ALND , with residual disease identified in 120 ( 63 % ) . The clipped node revealed metastases in 115 patients , result ing in an FNR of 4.2 % ( 95 % CI , 1.4 to 9.5 ) for the clipped node . In patients undergoing SLND and ALND ( n = 118 ) , the FNR was 10.1 % ( 95 % CI , 4.2 to 19.8 ) , which included seven false-negative events in 69 patients with residual disease . Adding evaluation of the clipped node reduced the FNR to 1.4 % ( 95 % CI , 0.03 to 7.3 ; P = .03 ) . The clipped node was not retrieved as an SLN in 23 % ( 31 of 134 ) of patients , including six with negative SLNs but metastasis in the clipped node . TAD followed by ALND was performed in 85 patients , with an FNR of 2.0 % ( 1 of 50 ; 95 % CI , 0.05 to 10.7 ) . CONCLUSION Marking nodes with biopsy-confirmed metastatic disease allows for selective removal and improves pathologic evaluation for residual nodal disease after chemotherapy PURPOSE High rates of mastectomy and marked regional variations have motivated lingering concerns about overtreatment and failure to involve women in treatment decisions . We examined the relationship between patient involvement in decision making and type of surgical treatment for women with breast cancer . METHODS All women with ductal carcinoma-in-situ and a 20 % r and om sample of women with invasive breast cancer aged 79 years and younger who were diagnosed in 2002 and reported to the Detroit and Los Angeles Surveillance , Epidemiology , and End Results registries were identified and surveyed shortly after receipt of surgical treatment ( response rate , 77.4 % ; n = 1,844 ) . RESULTS Mean age was 60.1 years ; 70.2 % of the women were white , 18.0 % were African American , and 11.8 % were from other ethnic groups . Overall , 30.2 % of women received mastectomy as initial treatment . Most women reported that they made the surgical decision ( 41.0 % ) or that the decision was shared ( 37.1 % ) ; 21.9 % of patients reported that their surgeon made the decision with or without their input . Among white women , only 5.3 % of patients whose surgeon made the decision received mastectomy compared with 16.8 % of women who shared the decision and 27.0 % of women who made the decision ( P < .001 , adjusted for clinical factors , predisposing factors , and number of surgeons visited ) . However , this association was not observed for African American women ( Wald test 10.0 , P = .041 ) . CONCLUSION Most women reported that they made or shared the decision about surgical treatment . More patient involvement in decision making was associated with greater use of mastectomy . Racial differences in the association of involvement with receipt of treatment suggest that the decision-making process varies by racial groups BACKGROUND Pre clinical data suggest that triple-negative breast cancers are sensitive to interstr and crosslinking agents , and that synergy may exist for the combination of a taxane , trastuzumab , and a platinum salt for HER2-positive breast cancer . We therefore aim ed to assess the efficacy of the addition of carboplatin to neoadjuvant therapy for triple-negative and HER2-positive breast cancer . METHODS Patients with previously untreated , non-metastatic , stage II-III , triple-negative breast cancer and HER2-positive breast cancer were enrolled . Patients were treated for 18 weeks with paclitaxel ( 80 mg/m(2 ) once a week ) and non-pegylated liposomal doxorubicin ( 20 mg/m(2 ) once a week ) . Patients with triple-negative breast cancer received simultaneous bevacizumab ( 15 mg/kg intravenously every 3 weeks ) . Patients with HER2-positive disease received simultaneous trastuzumab ( 8 mg/kg initial dose with subsequent doses of 6 mg/kg intravenously every 3 weeks ) and lapatinib ( 750 mg daily ) . Patients were r and omly assigned in a 1:1 ratio with dynamic allocation and minimisation , stratified by biological subtype and Ki-67 level to receive , at the same time as the backbone regimens , either carboplatin ( AUC 1·5 [ 2·0 for the first 329 patients ] once a week ) or no carboplatin . The primary endpoint the proportion of patients who achieved a pathological complete response ( defined as ypT0 ypN0 ) , analysed for all patients who started treatment ; a p value of less than 0·2 was deemed significant for the primary endpoint . This trial is registered with Clinical Trials.gov , number NCT01426880 . FINDINGS 296 patients were r and omly assigned to receive carboplatin and 299 to no additional carboplatin , of whom 295 and 293 started treatment , respectively . In this final analysis , 129 patients ( 43·7 % , 95 % CI 38·1 - 49·4 ) in the carboplatin group achieved a pathological complete response , compared with 108 patients ( 36·9 % , 31·3 - 42·4 ) without carboplatin ( odds ratio 1·33 , 95 % CI 0·96 - 1·85 ; p=0·107 ) . Of the patients with triple-negative breast cancer , 84 ( 53·2 % , 54·4 - 60·9 ) of 158 patients achieved a pathological complete response with carboplatin , compared with 58 ( 36·9 % , 29·4 - 44·5 ) of 157 without ( p=0·005 ) . Of the patients with HER2-positive tumours , 45 ( 32·8 % , 25·0 - 40·7 ) of 137 patients achieved a pathological complete response with carboplatin compared with 50 ( 36·8 % , 28·7 - 44·9 ) of 136 without ( p=0·581 ; test for interaction p=0·015 ) . Haematological and non-haematological toxic effects that were significantly more common in the carboplatin group than in the no-carboplatin group included grade 3 or 4 neutropenia ( 192 [ 65 % ] vs 79 [ 27 % ] ) , grade 3 or 4 anaemia ( 45 [ 15 % ] vs one [ < 1 % ] ) , grade 3 or 4 thrombocytopenia ( 42 [ 14 % ] vs one [ < 1 % ] ) , and grade 3 or 4 diarrhoea ( 51 [ 17 % ] vs 32 [ 11 % ] ) ; carboplatin was more often associated with dose discontinuations ( 141 [ 48 % ] with carboplatin and 114 [ 39 % ] without carboplatin ; p=0·031 ) . The frequency of grade 3 or 4 haematological events decreased from 82 % ( n=135 ) to 70 % ( n=92 ) and grade 3 or 4 non-haematological events from 78 % ( n=128 ) to 59 % ( n=77 ) in the carboplatin arm when the dose of carboplatin was reduced from AUC 2·0 to 1·5 . INTERPRETATION The addition of neoadjuvant carboplatin to a regimen of a taxane , an anthracycline , and targeted therapy significantly increases the proportion of patients achieving a pathological complete response . This regimen seems to increase responses in patients with triple-negative breast cancer , but not in those with HER2-positive breast cancer . FUNDING GlaxoSmithKline , Roche , and Teva Objective : To determine the effect of preoperative chemotherapy on the volume of tissue excised and the number of breast operations in patients undergoing breast-conserving therapy ( BCT ) . Summary Background Data : Preoperative chemotherapy is increasingly being used for breast cancer and increases rates of BCT . Its impact on the extent of surgery and the number of surgical procedures in BCT has never been fully defined . The extent of surgery in BCT directly affects cosmesis . Methods : We review ed the records of 509 consecutive patients with T1–T3 , N0–N2 breast cancer who were treated in prospect i ve r and omized clinical trials of chemotherapy between 1998 and 2005 . We analyzed the final surgical procedure ( BCT or mastectomy ) , the number of operations , and , in patients who underwent BCT , re-excision rates , and the total volume of breast tissue excised [ 4Π/3(width/2 × length/2 × height/2 ) ] . Results : A total of 241 patients underwent BCT , and 268 patients underwent mastectomy . Among BCT patients who had initial tumor size > 2.0 cm , patients who received preoperative chemotherapy had significantly smaller volumes of breast tissue excised compared with patients who received postoperative chemotherapy ( 113 cm3 vs. 213 cm3 , P = 0.004 ) . The re-excision rate and total number of breast operations did not significantly differ between the groups . Among BCT patients who had initial tumor size ≤2 cm , preoperative chemotherapy had no impact on volume of breast tissue excised , re-excision rate , or number of breast operations ( P > 0.05 ) . Conclusions : Among patients treated with BCT for larger breast tumors , patients treated with preoperative chemotherapy have less extensive resection , with no change in rates of re-excision IMPORTANCE Sentinel lymph node ( SLN ) surgery provides reliable nodal staging information with less morbidity than axillary lymph node dissection ( ALND ) for patients with clinical ly node-negative ( cN0 ) breast cancer . The application of SLN surgery for staging the axilla following chemotherapy for women who initially had node-positive cN1 breast cancer is unclear because of high false-negative results reported in previous studies . OBJECTIVE To determine the false-negative rate ( FNR ) for SLN surgery following chemotherapy in women initially presenting with biopsy-proven cN1 breast cancer . DESIGN , SETTING , AND PATIENTS The American College of Surgeons Oncology Group ( ACOSOG ) Z1071 trial enrolled women from 136 institutions from July 2009 to June 2011 who had clinical T0 through T4 , N1 through N2 , M0 breast cancer and received neoadjuvant chemotherapy . Following chemotherapy , patients underwent both SLN surgery and ALND . Sentinel lymph node surgery using both blue dye ( isosulfan blue or methylene blue ) and a radiolabeled colloid mapping agent was encouraged . MAIN OUTCOMES AND MEASURES The primary end point was the FNR of SLN surgery after chemotherapy in women who presented with cN1 disease . We evaluated the likelihood that the FNR in patients with 2 or more SLNs examined was greater than 10 % , the rate expected for women undergoing SLN surgery who present with cN0 disease . RESULTS Seven hundred fifty-six women were enrolled in the study . Of 663 evaluable patients with cN1 disease , 649 underwent chemotherapy followed by both SLN surgery and ALND . An SLN could not be identified in 46 patients ( 7.1 % ) . Only 1 SLN was excised in 78 patients ( 12.0 % ) . Of the remaining 525 patients with 2 or more SLNs removed , no cancer was identified in the axillary lymph nodes of 215 patients , yielding a pathological complete nodal response of 41.0 % ( 95 % CI , 36.7%-45.3 % ) . In 39 patients , cancer was not identified in the SLNs but was found in lymph nodes obtained with ALND , result ing in an FNR of 12.6 % ( 90 % Bayesian credible interval , 9.85%-16.05 % ) . CONCLUSIONS AND RELEVANCE Among women with cN1 breast cancer receiving neoadjuvant chemotherapy who had 2 or more SLNs examined , the FNR was not found to be 10 % or less . Given this FNR threshold , changes in approach and patient selection that result in greater sensitivity would be necessary to support the use of SLN surgery as an alternative to ALND . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00881361 Background : The American College of Surgeons Oncology Group Z1071 trial reported a false-negative rate ( FNR ) of 12.6 % with sentinel lymph node ( SLN ) surgery after neoadjuvant chemotherapy in women presenting with node-positive breast cancer . One proposed method to decrease the FNR is clip placement in the positive node at initial diagnosis with confirmation of clipped node resection at surgery . Methods : Z1071 was a multi-institutional trial wherein women with clinical T0–T4,N1–N2,M0 breast cancer underwent SLN surgery and axillary dissection ( ALND ) after neoadjuvant chemotherapy . In cases with a clip placed in the node , the clip location at surgery ( SLN or ALND ) was evaluated . Results : A clip was placed at initial node biopsy in 203 patients . In the 170 ( 83.7 % ) patients with cN1 disease and at least 2 SLNs resected , clip location was confirmed in 141 cases . In 107 ( 75.9 % ) patients where the clipped node was within the SLN specimen , the FNR was 6.8 % ( confidence interval [ CI ] : 1.9%–16.5 % ) . In 34 ( 24.1 % ) cases where the clipped node was in the ALND specimen , the FNR was 19.0 % ( CI : 5.4%–41.9 % ) . In cases without a clip placed ( n = 355 ) and in those where clipped node location was not confirmed at surgery ( n = 29 ) , the FNR was 13.4 % and 14.3 % , respectively . Conclusions : Clip placement at diagnosis of node-positive disease with removal of the clipped node during SLN surgery reduces the FNR of SLN surgery after neoadjuvant chemotherapy . Clip placement in the biopsy-proven node at diagnosis and evaluation of resected specimens for the clipped node should be considered when conducting SLN surgery in this setting Objective : To determine the accuracy of fine-needle aspiration ( FNA ) and vacuum-assisted core biopsy ( VACB ) in assessing the presence of residual cancer in the breast after neoadjuvant systemic therapy ( NST ) . Summary Background Data : Pathologic complete response ( pCR ) rates after NST have improved dramatically , suggesting that surgery might be avoided in some patients . Safe avoidance of surgery would require accurate confirmation of no residual invasive/in situ carcinoma . Methods : Forty patients with T1 - 3N0 - 3 triple-negative or HER2-positive cancer receiving NST were enrolled in this single-center prospect i ve trial . Patients underwent ultrasound-guided or mammography-guided FNA and VACB of the initial breast tumor region before surgery . Findings were compared with findings on pathologic evaluation of surgical specimens to determine the performance of biopsy in predicting residual breast disease after NST . Results : Median initial clinical tumor size was 3.3 cm ( range , 1.2–7.0 cm ) ; 16 patients ( 40 % ) had biopsy-proven nodal metastases . After NST , median clinical tumor size was 1.1 cm ( range , 0–4.2 cm ) . Nineteen patients ( 47.5 % ) had a breast pCR and were concordant with pathologic nodal status in 97.5 % . Combined FNA/VACB demonstrated an accuracy of 98 % ( 95 % CI , 87%–100 % ) , false-negative rate of 5 % ( 95 % CI , 0%–24 % ) , and negative predictive value of 95 % ( 95 % CI , 75%–100 % ) in predicting residual breast cancer . VACB alone was more accurate than FNA alone ( P = 0.011 ) . Conclusions : After NST , image-guided FNA/VACB can accurately identify patients with a breast pCR . Based on these results , a prospect i ve clinical trial has commenced in which breast surgery is omitted in patients with a breast pCR after NST according to image-guided biopsy |
1,365 | 29,141,651 | Conclusions This systematic review identified wide variation in the dose of behavioral interventions to prevent and treat pediatric obesity , but was unable to detect a clear relationship between dose and weight-related outcomes . | Background A better underst and ing of the optimal “ dose ” of behavioral interventions to affect change in weight-related outcomes is a critical topic for childhood obesity intervention research .
The objective of this review was to quantify the relationship between dose and outcome in behavioral trials targeting childhood obesity to guide future intervention development . | Background We developed a Dutch outpatient multidisciplinary group treatment ( Go4it ) for obese adolescents , including cognitive behavioural therapy and education on healthy dietary and physical activity behaviour . This study examined the effect of Go4it on Health Related Quality of Life ( HRQoL ) . Methods At our outpatient paediatric obesity clinic , obese adolescents ( n = 122 , 11–18 years ) were r and omly assigned to 1 ) Go4it , 7 sessions with an interval of 2 weeks or 2 ) current regular care consisting of referral to a dietician in the home care setting ( controls ) . Linear mixed model analysis was performed to evaluate the intervention effects on HRQoL at 6 and 18-month follow-ups . HRQoL indicators included the Child Health Question naire , the Paediatric Quality of Life Inventory ™ Version 4.0 ( PedsQL ™ 4.0 ) , and the Body Esteem Scale ( BES ) . Results In total , 95 adolescents ( Go4it 57 , controls 38 ) were included in the current analysis with a mean age of 14.5 ± 1.7 and mean BMI -SDS of 2.9 ± 0.5 . At baseline , all participants experienced lower levels of physical and psychosocial well-being compared to a normal weight reference group . At the 18 month follow-up , we found small but beneficial intervention effects on all subscales of the PedsQL ™ 4.0 and BES question naires . Two subscales improved significantly ; i.e. , physical health ( between group difference 5.4 ; 95%CI : 0.3 ; 10.6 ) , and school functioning ( between group difference 7.4 ; 95%CI : 1.6 ; 13.2 ) . Conclusion Obese adolescents experienced lower HRQoL than their healthy peers . The Go4it intervention had small beneficial effects on HRQoL compared to the current regular care practice s for obese adolescents . Trial registration Netherl and s Trial Register : IS RCT N27626398 , METC number : 05.134 ( WMO , monocenter ) Background There is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type 2 diabetes and cardiovascular disease risk in obese Latino adolescents . Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents . Our objectives were : 1 ) To pilot test a new 12-wk lifestyle intervention using a r and omized trial design in obese Latino adolescents , in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM ( IGI ) , over and above those of a didactic lifestyle education , on insulin resistance , eating and physical activity behaviors , stress and stress biomarkers ; and 2 ) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes , particularly insulin resistance . Methods Obese ( BMI > 95th percentile ) , Latino adolescents ( n = 35 , age 14 - 17 ) were r and omized to receive either 12 weekly sessions of a lifestyle education plus guided imagery program ( GI ) , or lifestyle education plus a digital storytelling computer program ( DS ) . Between-group differences in behavioral , biological , and psychological outcomes were assessed using unpaired T-tests and ANCOVA in the 29 subjects who completed the intervention . Results The GI group demonstrated significant reductions in leisure sedentary behavior ( p < .05 ) and increases in moderate physical activity ( p < .05 ) compared to DS group , and a trend toward reduced caloric intake in GI vs DS ( p = .09 ) . Salivary cortisol was acutely reduced by stress-reduction guided imagery ( p < .01 ) . There were no group differences in adiposity , insulin resistance , perceived stress , or stress biomarkers across the 12-week intervention , though decrease in serum cortisol over the course of the intervention was associated with improved insulin sensitivity ( p = .03 ) independent of intervention group and other relevant co-variates . Conclusions The improvements in physical activity and stress biomarkers following this pilot intervention support the role of guided imagery in promoting healthy lifestyle behavior change and reducing metabolic disease risk in obese Latino adolescent population s. Future investigations will be needed to determine the full effects of the Imagine HEALTH intervention on insulin resistance , stress , and stress biomarkers . Trial registration Clinical trials.gov Registry # : Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health . In 2005 a prevention protocol was developed applicable within Youth Health Care . This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children . Methods and design A cluster r and omised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams r and omised within 9 Municipal Health Services . The teams are r and omly allocated to the intervention or control group . The teams measure the weight and height of all children . When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI , the prevention protocol is applied . According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle , and are motivated for and assisted in behavioural change . The primary outcome measures are Body Mass Index and waist circumference of the children . Parents will complete question naires to assess secondary outcome measures : levels of overweight inducing/reducing behaviours ( i.e. being physically active , having breakfast , drinking sweet beverages and watching television/playing computer games ) , parenting styles , parenting practice s , and attitudes of parents regarding these behaviours , health-related quality of life of the children , and possible negative side effects of the prevention protocol . Data will be collected at baseline ( when the children are aged 5 years ) , and after 12 and 24 months of follow-up . Additionally , a process and a cost-effectiveness evaluation will be conducted . Discussion In this study called ' Be active , eat right ' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care . It is hypothesized that the use of this protocol will result in a healthier lifestyle of the children and an improved BMI and waist circumference . Trial registration Current Controlled Trials IS RCT Objective To determine whether modifying eating behaviour with use of a feedback device facilitates weight loss in obese adolescents . Design R and omised controlled trial with 12 month intervention . Setting Hospital based obesity clinic . Participants 106 newly referred obese young people aged 9 - 17 . Interventions A computerised device , M and ometer , providing real time feedback to participants during meals to slow down speed of eating and reduce total intake ; st and ard lifestyle modification therapy . Main outcome measures Change in body mass index ( BMI ) st and ard deviation score ( SDS ) over 12 months with assessment 18 months after the start of the intervention . Secondary outcomes were body fat SDS , metabolic status , quality of life evaluation , change in portion size , and eating speed . Results Using the last available data on all participants ( n=106 ) , those in the M and ometer group had significantly lower mean BMI SDS at 12 months compared with st and ard care ( baseline adjusted mean difference 0.24 , 95 % confidence interval 0.11 to 0.36 ) . Similar results were obtained when analyses included only the 91 who attended per protocol ( baseline adjusted mean difference 0.27 , 0.14 to 0.41 ; P<0.001 ) , with the difference maintained at 18 months ( 0.27 , 0.11 to 0.43 ; P=0.001 ) ( n=87 ) . The mean meal size in the M and ometer group fell by 45 g ( 7 to 84 g ) . Mean body fat SDS adjusted for baseline levels was significantly lower at 12 months ( 0.24 , 0.10 to 0.39 ; P=0.001 ) . Those in the M and ometer group also had greater improvement in concentration of high density lipoprotein cholesterol ( P=0.043 ) . Conclusions Retraining eating behaviour with a feedback device is a useful adjunct to st and ard lifestyle modification in treating obesity among adolescents . Trial registration Clinical Trials.gov NCT00407420 BACKGROUND AND OBJECTIVE : Most clinic-based weight control treatments for youth have been design ed for preadolescent children by using family-based care . However , as adolescents become more autonomous and less motivated by parental influence , this strategy may be less appropriate . This study evaluated a primary care – based , multicomponent lifestyle intervention specifically tailored for overweight adolescent females . METHODS : Adolescent girls ( N = 208 ) 12 to 17 years of age ( mean ± SD : 14.1 ± 1.4 years ) , with a mean ± SD BMI percentile of 97.09 ± 2.27 , were assigned r and omly to the intervention or usual care control group . The gender and developmentally tailored intervention included a focus on adoptable healthy lifestyle behaviors and was reinforced by ongoing feedback from the teen ’s primary care physician . Of those r and omized , 195 ( 94 % ) completed the 6-month posttreatment assessment , and 173 ( 83 % ) completed the 12-month follow-up . The primary outcome was reduction in BMI z score . RESULTS : The decrease in BMI z score over time was significantly greater for intervention participants compared with usual care participants ( −0.15 in BMI z score among intervention participants compared with −0.08 among usual care participants ; P = .012 ) . The 2 groups did not differ in secondary metabolic or psychosocial outcomes . Compared with usual care , intervention participants reported less reduction in frequency of family meals and less fast-food intake . CONCLUSIONS : A 5-month , medium-intensity , primary care – based , multicomponent behavioral intervention was associated with significant and sustained decreases in BMI z scores among obese adolescent girls compared with those receiving usual care INTRODUCTION The present study describes a r and omised controlled trial ( RCT ) based on a novel , generalisable intervention for childhood obesity , comparing the intervention with a no-treatment control group . METHOD The Malaysian Childhood Obesity Treatment Trial ( MASCOT ) was a single-blind RCT of a dietetic treatment for childhood obesity in children of primary school age ( 7 to 11 years old ) in Kuala Lumpur , Malaysia . The MASCOT comprising eight sessions , of an 8-hour family-centred group treatment programme is described , based on behavioural change techniques . The study sample was characterised by BMI z-score , health related quality of life reported by participants and their parents ( PedsQL question naire ) , objective ly measured habitual physical activity and sedentary behaviour ( Actigraph accelerometry ) RESULTS The MASCOT sample of 107 children was characterised by a low quality of life , mean total score on PedsQL 67.7 ( 4.5 ) as reported by the children , and 66.0 ( 16.4 ) as reported by their parents . The children spent , on average , 89 % of their waking day on sedentary activity , and 1 % of the day in moderate-vigorous intensity physical activity , equivalent to only around 8 minutes/day . CONCLUSION Obese children in the MASCOT study had an impaired quality of life , high levels of sedentary behaviour and very low levels of physical activity OBJECTIVE The objective was to compare targeting increased eating of healthy foods vs. reducing intake of high energy-dense foods within the context of a family-based behavioral weight control program . METHODS AND PROCEDURES Forty-one 8 - 12 year-old children > 85th BMI percentile were r and omly assigned to a 24-month family-based behavioral treatment that targeted increasing fruits and vegetables and low-fat dairy vs. reducing intake of high energy-dense foods . RESULTS Children in the increase healthy food group showed greater reduction in z BMI compared to children in the reduce high energy-dense food group at 12- ( -0.30 z BMI units vs. -0.15 z BMI units , P = 0.01 ) and 24- ( -0.36 z BMI units vs -0.13 z BMI units , P = 0.04 ) month follow-up . Parents in the increase healthy food group showed greater reductions in concern about child weight ( P = 0.007 ) , and these changes were associated with child z BMI change ( P = 0.008 ) . Children in the reduce high energy-dense group showed larger sustained reductions in high energy-dense foods ( P < 0.05 ) . Baseline levels of high energy-dense foods ( P < 0.05 ) , parent food restraint ( P = 0.01 ) , parent concern over parent weight ( P = 0.01 ) and parent acceptance of the child ( P < 0.05 ) moderated child z BMI change , with greater sustained reductions in z BMI for children in the increase healthy food group for each measure . Parent z BMI change followed the same pattern as child changes , and parent and child z BMI changes were correlated ( P < 0.001 ) . DISCUSSION Focusing on healthy food choices within an energy restricted diet may be useful in family-based weight control programs OBJECTIVE To assess the process variables involved in a weight loss program for African-American adolescent girls . Several process variables have been identified as affecting success in in vivo weight loss programs for adults and children , including program adherence , self-efficacy , and social support . The current study sought to broaden the underst and ing of these process variables as they pertain to an intervention program that is presented using the Internet . It was hypothesized that variables such as program adherence , dietary self-efficacy , psychological factors , and family environment factors would mediate the effect of the experimental condition on weight loss . RESEARCH METHODS AND PROCEDURES Participants were 57 adolescent African-American girls who joined the program with one obese parent ; family pairs were r and omized to either a behavioral or control condition in an Internet-based weight loss program . Outcome data ( weight loss ) are reported for the first 6 months of the intervention . RESULTS Results partially supported the hypotheses . For weight loss among adolescents , parent variables pertaining to life and family satisfaction were the strongest mediating variables . For parental weight loss , changes in dietary practice s over the course of 6 months were the strongest mediators . DISCUSSION The identification of factors that enhance or impede weight loss for adolescents is an important step in improving weight loss programs for this group . The current findings suggest that family/parental variables exert a strong influence on weight loss efforts for adolescents and should be considered in developing future programs OBJECTIVE To test the feasibility , acceptability , and potential efficacy of after-school dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , among African-American girls . DESIGN Twelve-week , 2-arm parallel group , r and omized controlled trial . SETTING Low-income neighborhoods . PARTICIPANTS Sixty-one 8 - 10-year-old African-American girls and their parents/guardians . INTERVENTIONS The treatment intervention consisted of after-school dance classes at 3 community centers , and a 5-lesson intervention , delivered in participants ' homes , and design ed to reduce television , videotape , and video game use . The active control intervention consisted of disseminating newsletters and delivering health education lectures . MAIN OUTCOME MEASURES Implementation and process measures , body mass index , waist circumference , physical activity measured by accelerometry , self-reported media use , and meals eaten with TV . RESULTS Recruitment and retention goals were exceeded . High rates of participation were achieved for assessment s and intervention activities , except where transportation was lacking . All interventions received high satisfaction ratings . At follow up , girls in the treatment group , as compared to the control group , exhibited trends toward lower body mass index ( adjusted difference = -.32 kg/m2 , 95 % confidence interval [ CI ] -.77 , .12 ; Cohen 's d = .38 st and ard deviation units ) and waist circumference ( adjusted difference = -.63 cm , 95 % CI -1.92 , .67 ; d = .25 ) ; increased after-school physical activity ( adjusted difference = 55.1 counts/minute , 95 % CI -115.6 , 225.8 ; d = .21 ) ; and reduced television , videotape , and video game use ( adjusted difference = -4.96 hours/week , 95 % CI -11.41 , 1.49 ; d = .40 ) . The treatment group reported significantly reduced household television viewing ( d = .73 , P = .007 ) and fewer dinners eaten while watching TV ( adjusted difference = -1.60 meals/week , 95 % CI -2.99 , -.21 ; d = .59 ; P = .03 ) . Treatment group girls also reported less concern about weight ( d = .60 ; P = .03 ) , and a trend toward improved school grade s ( d = .51 ; P = .07 ) . CONCLUSIONS This study confirmed the feasibility , acceptability , and potential efficacy of using dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , in African-American girls BACKGROUND The high prevalence and incidence of obesity and eating disorders in US adolescent girls are serious health problems . Because of the shared risk factors for obesity and eating disorders , a targeted prevention of both conditions is a priority . OBJECTIVE We determined whether an adapted interpersonal psychotherapy prevention program is more efficacious for reducing excess weight gain and worsening disordered eating than health education in adolescent girls at high risk of obesity and eating disorders . DESIGN A parallel-group , r and omized controlled trial was conducted between September 2008 and January 2013 in a university-based laboratory and a federal research hospital . The study included 113 adolescent ( 12 - 17-y-old ) girls deemed at high risk of adult obesity and eating disorders because of a body mass index ( BMI ) between the 75th and 97th percentiles and reports of episodes of a loss of control over their eating . Girls were r and omly assigned to participate in an adapted interpersonal psychotherapy or a health-education group program for 12 weekly 90-min group sessions . Follow-up assessment s occurred immediately after group programs and at 6 and 12 mo . RESULTS Participation in both conditions was associated with decreases in expected BMI gain , age-adjusted BMI metrics , the percentage of fat by using dual-energy X-ray absorptiometry , symptoms of depression and anxiety , and the frequency of loss-of-control eating over 12 mo of follow-up ( Ps < 0.001 ) with no group difference . In follow-up analyses , interpersonal psychotherapy was more efficacious than health education at reducing objective binge eating at the 12-mo follow-up ( P < 0.05 ) . CONCLUSIONS The intervention with adolescent girls with loss-of-control eating is associated with lower age-adjusted BMI and percentage of adiposity as well as improved mood symptoms over 1 y. Interpersonal psychotherapy further reduced objective binge eating . Additional research is needed to eluci date the mechanisms by which physical and psychological improvements were observed . This trial was registered at clinical trials.gov as NCT00680979 BACKGROUND The prevalence of obesity in the United States is a significant public health problem . Many obesity-related risk factors are more prevalent in minority population s. Given the recalcitrant nature of weight loss interventions for adults , prevention of overweight and obesity has become a high priority . The present study reports baseline data from an obesity prevention intervention developed for minority preschool children . METHODS Hip-Hop to Health Jr. is a 5-year r and omized controlled intervention that targets 3- to 5-year-old minority children enrolled in 24 Head Start programs . Our primary aim is to test the effect of the intervention on change in body mass index . Data were collected on sociodemographic , anthropometric , behavioral , and cognitive variables for the children and parents at baseline . RESULTS Participants included 416 black children , 337 black parents , 362 Latino children , and 309 Latino parents . Using body mass index for age and sex > or = the 95th percentile as the definition of overweight , 15 % of the black children and 28 % of the Latino children were overweight . More than 75 % of the parents were either overweight or obese . DISCUSSION The development of interventions to effectively prevent or control obesity early in life is crucial . These data highlight the escalating problem of weight control in minority population OBJECTIVE To evaluate the feasibility , acceptability , and efficacy of an after-school team sports program for reducing weight gain in low-income overweight children . DESIGN Six-month , 2-arm , parallel-group , pilot r and omized controlled trial . SETTING Low-income , racial/ethnic minority community . PARTICIPANTS Twenty-one children in grade s 4 and 5 with a body mass index at or above the 85th percentile . INTERVENTIONS The treatment intervention consisted of an after-school soccer program . The " active placebo " control intervention consisted of an after-school health education program . MAIN OUTCOME MEASURES Implementation , acceptability , body mass index , physical activity measured using accelerometers , reported television and other screen time , self-esteem , depressive symptoms , and weight concerns . RESULTS All 21 children completed the study . Compared with children receiving health education , children in the soccer group had significant decreases in body mass index z scores at 3 and 6 months and significant increases in total daily , moderate , and vigorous physical activity at 3 months . CONCLUSION An after-school team soccer program for overweight children can be a feasible , acceptable , and efficacious intervention for weight control Background Childhood obesity is one of the most pressing health issues of our time . Key health organizations have recommended research be conducted on the effectiveness of well- design ed interventions to combat childhood obesity that can be translated into a variety of setting s. This paper describes the design and methods used in the Hunter Illawarra Kids Challenge Using Parent Support ( HIKCUPS ) trial , an ongoing multi-site r and omized controlled trial , in overweight/obese children comparing the efficacy of three interventions : 1 ) a parent-centered dietary modification program ; 2 ) a child-centered physical activity skill-development program ; and 3 ) a program combining both 1 and 2 above . Methods / Design Each intervention consists of three components : i ) 10-weekly face-to-face group sessions ; ii ) a weekly homework component , completed between each face-to-face session and iii ) three telephone calls at monthly intervals following completion of the 10-week program . Details of the programs ' method ological aspects of recruitment , r and omization and statistical analyses are described here a priori . Discussion Importantly this paper describes how HIKCUPS addresses some of the short falls in the current literature pertaining to the efficacy of child obesity interventions .The HIKCUPS trial is funded by the National Medical Research Council , Australia OBJECTIVE . The objective of this study was to determine whether a generalizable best- practice individualized behavioral intervention reduced BMI z score relative to st and ard dietetic care among overweight children . METHODS . The design consisted of an assessor-blinded , r and omized , controlled trial involving 134 overweight children ( 59 boys , 75 girls ; BMI ≥ 98th centile relative to United Kingdom 1990 reference data for children aged 5–11 years ) who were r and omly assigned to a best- practice behavioral program ( intervention ) or st and ard care ( control ) . The intervention used family-centered counseling and behavioral strategies to modify diet , physical activity , and sedentary behavior . BMI z score , weight , objective ly measured physical activity and sedentary behavior , fat distribution , quality of life , and height z score were recorded at baseline and at 6 and 12 months . RESULTS . The intervention had no significant effect relative to st and ard care on BMI z score from baseline to 6 months and 12 months . BMI z score decreased significantly in both groups from baseline to 6 and 12 months . For those who complied with treatment , there was a significantly smaller weight increase in those in the intervention group compared with control subjects from baseline to 6 months . There were significant between-group differences in favor of the intervention for changes in total physical activity , percentage of time spent in sedentary behavior , and light-intensity physical activity . CONCLUSIONS . A generalizable , best- practice individualized behavioral intervention had modest benefits on objective ly measured physical activity and sedentary behavior but no significant effect on BMI z score compared with st and ard care among overweight children . The modest magnitude of the benefits observed perhaps argues for a longer-term and more intense intervention , although such treatments may not be realistic for many health care systems BACKGROUND In view of the growing trend of obesity around the world , including in our country , and the effect of reduced physical activity in increasing the incidence of obesity and overweight in children and adolescents and limitations of families in providing transport for their children to attend exercise classes , as well as time limitations of students in taking part in these classes , accessing appropriate methods for presenting physical activity training seems essential . METHODS This non-pharmacological clinical trial was performed during six months from May to November 2007 on 105 children and adolescents aged 6 - 18 years with obesity , r and omly assigned to 3 groups of thirty-five . Nutrition and treatment behavior were the same in all groups , but physical activity training in the first group was taking part in physical activity training classes twice a week , in the second group by providing a training CD , and in the third group via face-to-face training . Before and after the intervention , anthropometric indicators were measured and recorded . RESULTS Mean body mass index ( BMI ) of participants in group attended physical activity training classes , and in the group undergone training with CD , after the interventions was significantly lower than that before the intervention . CONCLUSION Our findings demonstrated that training using CDs can also be effective in reducing BMI in overweight and obese children and adolescents as much as face-to-face education and participation in physical training classes . Extending such interventions can be effective at the community level Studies have shown preventive effects of an active lifestyle during childhood on later life ; therefore , health promotion has to start early . The programme “ Join the Healthy Boat ” promotes a healthy lifestyle in primary school children . In order to evaluate it , children 's behaviours in respect of increased physical activity ( PA ) , a decrease in screen media use ( SMU ) , more regular breakfast , and a reduction of the consumption of soft drinks ( SDC ) were investigated . 1943 children ( 7.1 ± 0.6 years ) participated in the cluster-r and omised study and were assessed at baseline and 1736 of them at follow-up . Teachers delivered lessons , which included behavioural contracting and budgeting of SMU and SDC . Daily SMU , PA behaviours , SDC , and breakfast patterns were assessed via parental question naire . After one-year intervention , significant effects were found in the intervention group for SMU of girls , children without migration background , and children with parents having a low education level . In the control group , second grade children skipped breakfast significantly more often . Tendencies but no significant differences were found for PA and SDC . This intervention seems to affect groups , which are usually hard to reach , such as children of parents with low education levels , which shows that active parental involvement is vital for successful interventions OBJECTIVE The study presents the immediate post-intervention results of Kids and Adults Now - Defeat Obesity ! , a r and omized controlled trial to enhance healthy lifestyle behaviors in mother-preschooler ( 2 - 5 years old ) dyads in North Carolina ( 2007 - 2011 ) . The outcomes include change from baseline in the child 's diet , physical activity and weight , and in the mother 's parenting behaviors , diet , physical activity , and weight . METHOD The intervention targeted parenting through maternal emotion regulation , home environment , feeding practice s , and modeling of healthy behaviors . 400 mother-child dyads were r and omized . RESULTS Mothers in the intervention arm , compared to the control arm , reduced instrumental feeding ( -0.24 vs. 0.01 , p<0.001 ) and TV snacks ( -.069 vs. -0.24 , p=0.001 ) . There were also improvements in emotional feeding ( p=0.03 ) , mother 's sugary beverage ( p=0.03 ) and fruit/vegetable ( p=0.04 ) intake , and dinners eaten in front of TV ( p=0.01 ) ; these differences were not significant after adjustment for multiple comparisons . CONCLUSION KAN-DO , design ed to maximize the capacity of mothers as agents of change , improved several channels of maternal influence . There were no group differences in the primary outcomes , but differences were observed in the parenting and maternal outcomes and there were trends toward improvement in the preschoolers ' diets . Long-term follow-up will address whether these short-term trends ultimately improve weight status BACKGROUND Epidemiological studies have shown television watching to be a risk factor for the development of obesity in children . The effect of reducing television watching and other sedentary behaviors as a component of a comprehensive obesity treatment program has not been thoroughly tested . OBJECTIVE To compare the influence of targeting decreases in sedentary behavior vs. increases in physical activity in the comprehensive treatment of obesity in 8- to 12-year-old children . DESIGN R and omized , controlled outcome study . SETTING Childhood obesity research clinic . DESIGN Ninety families with obese 8- to 12-year-old children were r and omly assigned to groups that were provided a comprehensive family-based behavioral weight control program that included dietary , and behavior change information but differed in whether sedentary or physically active behaviors were targeted and the degree of behavior change required . RESULTS Results during 2 years showed that targeting either decreased sedentary behaviors or increased physical activity was associated with significant decreases in percent overweight and body fat and improved aerobic fitness . Self-reported activity minutes increased and targeted sedentary time decreased during treatment . Children substituted nontargeted sedentary behaviors for some of their targeted sedentary behaviors . CONCLUSION These results support reducing sedentary behaviors as an adjunct in the treatment of pediatric obesity Objective Approximately 7 % of children and young people aged 5–15 years in the UK have obesity at a level likely to be associated with comorbidities . The majority of multicomponent lifestyle programmes have limited applicability and generalisability for British adolescents . The Healthy Eating and Lifestyle Programme ( HELP ) was a specific adolescent-focused intervention , design ed for obese 12 to 18-year-olds seeking help to manage their weight . Participants were r and omised to the 12-session HELP intervention or st and ard care . The primary outcome was difference in mean body mass index ( BMI ) ( kg/m2 ) between groups at week 26 adjusted for baseline BMI , age and sex . Subjects 174 subjects were r and omised ( 87 in each arm ) , of whom 145 ( 83 % ) provided primary outcome data at week 26 . Results At week 26 there were no significant effects of the intervention on BMI ( mean change in BMI 0.18 kg/m2 for the intervention arm , 0.25 kg/m2 for the control arm ; adjusted difference between groups : −0.11 kg/m2 ( 95 % CI −0.62 to 0.40 ) , p=0.7 ) . At weeks 26 and 52 there were no significant differences between groups in any secondary outcomes . Conclusion At minimum this study reinforces the need for higher level , structured interventions to tackle the growing public health burden of obesity in the UK and internationally . The HELP intervention was no more effective than a single educational session for reducing BMI in a community sample of obese adolescents . Further work is needed to underst and how weight management programmes can be delivered effectively to young people from diverse and deprived background s in which childhood obesity is common . The study has significant implication s in terms of informing public health interventions to tackle childhood obesity . Trial registration number IS RCT N : IS RCT N99840111 Obesity is highly prevalent in asthmatic children and associated with worse clinical outcomes . Energy restriction to induce weight loss in asthmatic children has not been investigated in a r and omized controlled trial ( RCT ) OBJECTIVE The objective of the current study was to examine the effectiveness of a multidisciplinary weekly family-based behavioral group delivered via telemedicine to rural areas , compared with a st and ard physician visit intervention . METHODS A r and omized controlled trial was conducted with 58 rural children and their families comparing a family-based behavioral intervention delivered via telemedicine to a structured physician visit condition . Outcome measures included child body mass index z-score ( BMI z ) , 24-hr dietary recalls , accelerometer data , Child Behavior Checklist , Behavioral Pediatrics Feeding Assessment Scale , and feasibility and fidelity . RESULTS Child BMI z outcomes were not statistically different between the 2 groups ( F = 0.023 , p = .881 ) . Improvements in BMI z , nutrition , and physical activity were seen for both groups . CONCLUSIONS Both telemedicine and structured physician visit may be feasible and acceptable methods of delivering pediatric obesity treatment to rural children Background Childhood obesity has reached epidemic proportions in developed countries . Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity . Active video games , where players physically interact with images onscreen , may have utility as a novel intervention to increase physical activity and improve body composition in children . The aim of the Electronic Games to Aid Motivation to Exercise ( eGAME ) study is to determine the effects of an active video game intervention over 6 months on : body mass index ( BMI ) , percent body fat , waist circumference , cardio-respiratory fitness , and physical activity levels in overweight children . Methods / Design Three hundred and thirty participants aged 10–14 years will be r and omized to receive either an active video game up grade package or to a control group ( no intervention ) . Discussion An overview of the eGAME study is presented , providing an example of a large , pragmatic r and omized controlled trial in a community setting . Reflection is offered on key issues encountered during the course of the study . In particular , investigation into the feasibility of the proposed intervention , as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial . Trial registration Australian New Zeal and Clinical Trials Registry PURPOSE To examine the feasibility and efficacy of a theory-driven and family-based program delivered online to promote healthy lifestyles and weights in Chinese American adolescents . METHODS A r and omized controlled study of a web-based intervention was developed and conducted in 54 Chinese American adolescents ( ages , 12 - 15 years ) and their families . Data on anthropometry , blood pressure , dietary intake , physical activity , and knowledge and self-efficacy regarding physical activity and nutrition were collected at baseline and 2 , 6 , and 8 months after the baseline assessment . Data were analyzed using linear mixed modeling . RESULTS The intervention result ed in significant decreases in waist-to-hip ratio and diastolic blood pressure and increases in vegetable and fruit intake , level of physical activity , and knowledge about physical activity and nutrition . CONCLUSION This web-based behavior program for Chinese American adolescents and their families seems feasible and effective in the short-term . Long-term effects remain to be determined . This type of program can be adapted for other minority ethnic groups who are at high-risk for overweight and obesity and have limited access to programs that promote healthy lifestyles Obese children ( 8 - 13 years old ) and at least one of their parents participated in a behaviorally oriented treatment program . Participants in a st and ard treatment condition experienced a multicomponent intervention in which parents were given primary responsibility for following program prescriptions . An enhanced child involvement condition provided the same basic intervention but with greater emphasis on , and training in , child self-regulation . Children in both conditions achieved a significant reduction in percentage overweight and triceps skin-fold during the 6-month treatment period . Overall , the follow-up period of 3 years was characterized by increases above posttreatment levels . There was , however , some suggestion in the 3-year follow-up results and the long-term patterns over a 6 1/2-year period of the benefits of the enhanced child involvement approach . Findings are discussed in terms of suggestions for reconsideration of treatment goals , improved interventions , and refinements in the assessment of self-regulatory behavior Background Involvement in meal preparation and eating meals with one ’s family are associated with better dietary quality and healthy body weight for youth . Given the poor dietary quality of many youth , potential benefits of family meals for better nutritional intake and great variation in family meals , development and evaluation of interventions aim ed at improving and increasing family meals are needed . This paper presents the design of key intervention components and process evaluation of a community-based program ( Healthy Home Offerings via the Mealtime Environment ( HOME ) Plus ) to prevent obesity . Methods The HOME Plus intervention was part of a two-arm ( intervention versus attention-only control ) r and omized-controlled trial . Ten monthly , two-hour sessions and five motivational/ goal - setting telephone calls to promote healthy eating and increasing family meals were delivered in community-based setting s in the Minneapolis/St . Paul , MN metropolitan area . The present study included 81 families ( 8 - 12 year old children and their parents ) in the intervention condition . Process surveys were administered at the end of each intervention session and at a home visit after the intervention period . Chi-squares and t-tests were used for process survey analysis . Results The HOME Plus program was successfully implemented and families were highly satisfied . Parents and children reported that the most enjoyable component was cooking with their families , learning how to eat more healthfully , and trying new recipes/foods and cooking tips . Average session attendance across the ten months was high for families ( 68 % ) and more than half completed their home activities . Conclusions Findings support the value of a community-based , family-focused intervention program to promote family meals , limit screen time , and prevent obesity . Trial registration CONTEXT Hypoadiponectinemia and chronic sub clinical inflammation in adults are associated with the development of diabetes and cardiovascular disease . The potential relationship between adiponectin and inflammation and its modulation by lifestyle intervention in the pediatric obese population remain unclear . OBJECTIVES The objectives were to investigate in adolescents 1 ) the relationship between adiponectin and obesity-related inflammatory factors , C-reactive protein , and IL-6 ; and 2 ) the effect of a lifestyle intervention on adiponectin and whether these effects are related to changes in inflammatory factors . RESEARCH METHODS AND PROCEDURES Twenty-one obese and age-matched lean adolescents ( age , 14 - 18 yr ; Tanner stage , > or = IV ) were studied cross-sectionally . Fifteen obese adolescents also underwent a r and omized , controlled physical activity-behavior-diet-based lifestyle intervention for 3 months . Associations among adiponectin , fat mass , insulin resistance , and inflammatory factors at baseline as well as after the intervention were assessed . RESULTS Plasma adiponectin concentration was lower ( P < 0.001 ) in the obese vs. age-matched lean adolescents . Significant inverse relationships were observed between adiponectin and inflammatory factors , insulinemia , insulin resistance , and fat mass . Intervention produced a 34 % increase in adiponectin concentration ( P = 0.0004 ) despite negligible weight loss but with reductions in fat mass , hyperinsulinemia , insulin resistance , and inflammatory factors ( all P < 0.01 ) . CONCLUSIONS The data suggest that in adolescents , obesity-related hypoadiponectinemia is associated with sub clinical inflammation , and a short-term lifestyle intervention augments adiponectin concentrations . These effects appear to be related to reductions in fat mass and inflammatory factors . Based on our current underst and ing of adiponectin physiology , reversal of hypoadiponectinemia in obese adolescents may protect against risks for cardiovascular disease and diabetes BACKGROUND Despite the high prevalence and negative physical and psychosocial consequences of overweight and obesity in adolescents , very little research has evaluated treatment in this population . Consequently , clinicians working with overweight and obese adolescents have little empirical research on which to base their practise . Cognitive behavioural therapy has demonstrated efficacy in promoting behaviour change in many treatment resistant disorders . Motivational interviewing has been used to increase motivation for change and improve treatment outcomes . In this paper we describe the rationale and design of a r and omised controlled trial testing the efficacy of motivational interviewing and cognitive behaviour therapy in the treatment of overweight and obese adolescents . METHODS Participants took part in a motivational interview or a st and ard semi-structured assessment interview and were then r and omly allocated to a cognitive behavioural intervention or a wait-list control condition . The cognitive behavioural intervention , the CHOOSE HEALTH Program , consisted of 13 individual treatment sessions ( 12 face-to-face , 1 phone call ) followed by 9 maintenance sessions ( 7 phone calls , 2 face-to-face ) . Assessment s were conducted prior to participation , after the treatment phase and after the maintenance phase of intervention . Improvement in body composition was the primary outcome ; secondary outcomes included improved cardiovascular fitness , eating and physical activity habits , family and psychosocial functioning . CONCLUSION Despite the demonstrated effectiveness of motivational interviewing and cognitive behavioural therapy in the long-term management of many treatment resistant disorders , these approaches have been under-utilised in adolescent overweight and obesity treatment . This study provides baseline data and a thorough review of the study design and treatment approach to allow for the assessment of the efficacy of motivational interviewing and cognitive behavioural therapy in the treatment of adolescent overweight and obesity . Data obtained in this study will also provide much needed information about the behavioural and psychosocial factors associated with adolescent overweight and obesity Background Childhood obesity is an increasing health problem globally . Overweight and obesity may be established as early as 2–5 years of age , highlighting the need for evidence -based effective prevention and treatment programs early in life . In adults , mobile phone based interventions for weight management ( mHealth ) have demonstrated positive effects on body mass , however , their use in child population s has yet to be examined . The aim of this paper is to report the study design and methodology of the MINSTOP ( Mobile-based Intervention Intended to Stop Obesity in Preschoolers ) trial . Methods / Design A two-arm , parallel design r and omized controlled trial in 300 healthy Swedish 4-year-olds is conducted . After baseline measures , parents are allocated to either an intervention- or control group . The 6- month mHealth intervention consists of a web-based application ( the MINSTOP app ) to help parents promote healthy eating and physical activity in children . MINISTOP is based on the Social Cognitive Theory and involves the delivery of a comprehensive , personalized program of information and text messages based on existing guidelines for a healthy diet and active lifestyle in pre-school children . Parents also register physical activity and intakes of c and y , soft drinks , vegetables as well as fruits of their child and receive feedback through the application . Primary outcomes include body fatness and energy intake , while secondary outcomes are time spent in sedentary , moderate , and vigorous physical activity , physical fitness and intakes of fruits and vegetables , snacks , soft drinks and c and y. Food and energy intake ( Tool for Energy balance in Children , TECH ) , body fatness ( pediatric option for BodPod ) , physical activity ( Actigraph wGT3x-BT ) and physical fitness ( the PREFIT battery of five fitness tests ) are measured at baseline , after the intervention ( six months after baseline ) and at follow-up ( 12 months after baseline ) . Discussion This novel study will evaluate the effectiveness of a mHealth program for mitigating gain in body fatness among 4-year-old children . If the intervention proves effective it has great potential to be implemented in child-health care to counteract childhood overweight and obesity . Trial registration Clinical Trials.gov NCT02021786 ; 20 Dec 2013 Background Increasing prevalences of overweight and obesity in children are known problems in industrialized countries . Early prevention is important as overweight and obesity persist over time and are related with health problems later in adulthood . " Komm mit in das gesunde Boot - Grundschule " is a school-based program to promote a healthier lifestyle . Main goals of the intervention are to increase physical activity , decrease the consumption of sugar-sweetened beverages , and to decrease time spent sedentary by promoting active choices for healthy lifestyle . The program to date is distributed by 34 project delivery consultants in the state of Baden-Württemberg and is currently implemented in 427 primary schools . The efficacy of this large scale intervention is examined via the Baden-Württemberg Study . Methods / Design The Baden-Württemberg Study is a prospect i ve , stratified , cluster-r and omized , and longitudinal study with two groups ( intervention group and control group ) . Measurements were taken at the beginning of the academic years 2010/2011 and 2011/2012 . Efficacy of the intervention is being assessed using three main outcomes : changes in waist circumference , skinfold thickness and 6 minutes run . Stratified cluster-r and omization ( according to class grade level ) was performed for primary schools ; pupils , teachers/principals , and parents were investigated . An approximately balanced number of classes in intervention group and control group could be reached by stratified r and omization and was maintained at follow-up . Discussion At present , " Komm mit in das Gesunde Boot - Grundschule " is the largest school-based health promotion program in Germany . Comparative objective main outcomes are used for the evaluation of efficacy . Simulations showed sufficient power with the existing sample size . Therefore , the results will show whether the promotion of a healthier lifestyle in primary school children is possible using a relatively low effort within a school-based program involving children , teachers and parents . The research team anticipates that not only efficacy will be proven in this study but also expects many other positive effects of the program . Trial registration German Clinical Trials Register ( DRKS ) , DRKS-ID : This article examines the effectiveness of group-based weight-control treatment on adolescent social functioning . Eighty-nine adolescents , who were r and omized to group-based cognitive behavioral treatment with aerobic exercise or peer-enhanced adventure therapy , completed measures of social functioning at baseline , end of treatment , and at a 12-month follow up . Results demonstrated significant reductions in adolescent perceptions of peer rejection and social anxiety over time , with no significant demonstrated group differences . Improvements in social functioning were related to increases in self-concept dimensions . Findings demonstrate benefits of group-based weight-control treatment for enhancing adolescent self-perceived social functioning across multiple domains Background Effective interventions on screen-time behaviours ( television , video games and computer time ) are needed to prevent non-communicable diseases in low- and middle-income countries . The present manuscript investigates the effect of a school-based health promotion intervention on screen-time behaviour among 12- to 15-year-old adolescents . We report the effect of the trial on screen-time after two stages of implementation . Methods We performed a cluster-r and omised pair matched trial in urban schools in Cuenca-Ecuador . Participants were adolescents of grade eight and nine ( mean age 12.8 ± 0.8 years , n = 1370 , control group n = 684 ) from 20 schools ( control group n = 10 ) . The intervention included an individual and environmental component tailored to the local context and re sources . The first intervention stage focused on diet , physical activity and screen-time behaviour , while the second stage focused only on diet and physical activity . Screen-time behaviours , primary outcome , were assessed at baseline , after the first ( 18 months ) and second stage ( 28 months ) . Mixed linear models were used to analyse the data . Results After the first stage ( data from n = 1224 adolescents ; control group n = 608 ) , the intervention group had a lower increase in TV-time on a week day ( β = −15.7 min ; P = 0.003 ) and weekend day ( β = −18.9 min ; P = 0.005 ) , in total screen-time on a weekday ( β = −25.9 min ; P = 0.03 ) and in the proportion of adolescents that did not meet the screen-time recommendation ( β = −4 percentage point ; P = 0.01 ) , compared to the control group . After the second stage ( data from n = 1078 adolescents ; control group n = 531 ) , the TV-time on a weekday ( β = 13.1 min ; P = 0.02 ) , and total screen-time on a weekday ( β = 21.4 min ; P = 0.03 ) increased more in adolescents from the intervention group . No adverse effects were reported . Discussion and Conclusion A multicomponent school-based intervention was only able to mitigate the increase in adolescents ’ television time and total screen-time after the first stage of the intervention or in other words , when the intervention included specific components or activities that focused on reducing screen-time . After the second stage of the intervention , which only included components and activities related to improve healthy diet and physical activity and not to decrease the screen-time , the adolescents increased their screen-time again . Our findings might imply that reducing screen-time is only possible when the intervention focuses specifically on reducing screen-time . Trial registration Clinical trials.gov identifier NCT01004367 Background In children , the prevalence ’s of both obesity and asthma are disconcertingly high . Asthmatic children with obesity are characterised by less asthma control and a high need for asthma medication . As the obese asthmatic child is becoming more common in the clinical setting and the disease burden of the asthma-obesity phenotype is high , there is an increasing need for effective treatment in these children . In adults , weight reduction result ed in improved lung function , better asthma control and less need for asthma medication . In children this is hardly studied . The Mikado study aims to evaluate the effectiveness of a long term multifactorial weight reduction intervention , on asthma characteristics in children with asthma and a high body weight . Methods / design The Mikado study is a two-armed , r and omised controlled trial . In total , 104 participants will be recruited via online question naires , pulmonary paediatricians , the youth department of the Municipal Health Services and cohorts of existing studies . All participants will be aged 6–16 years , will have current asthma , a Body Mass Index in the overweight or obesity range , and no serious comorbidities ( such as diabetes , heart diseases ) . Participants in the intervention arm will receive a multifactorial intervention of 18 months consisting of sessions concerning sports , parental involvement , individual counselling and lifestyle advices including dietary advices and cognitive behavioural therapy . The control group will receive usual care . The primary outcome variables will include Forced Expiratory Volume in one second and Body Mass Index - St and ard Deviation Score . Secondary outcomes will include other lung function parameters ( including dynamic and static lung function parameters ) , asthma control , asthma-specific quality of life , use of asthma medication and markers of systemic inflammation and airway inflammation . Discussion In this r and omised controlled trial we will study the potential of a multifactorial weight reduction intervention to improve asthma-related outcome measures in asthmatic children with overweight . Moreover , it will provide information about the underlying mechanisms in the relationship between asthma and a high body weight in children . These findings can contribute to optimal management programs and better clinical guidelines for children with asthma and overweight . Trial registration Clinical trial.gov Objective : This study sought to document self-reported binge eating in a large sample of severely obese children and to examine the impact of binge eating on changes in percent overweight among children r and omized to family-based behavioral treatment ( intervention ) versus control ( usual care ) . Participants and methods : As part of a larger r and omized controlled trial , 192 children aged 8–12 years ( M=10.2 , s.d.=1.2 ) with a mean body mass index ( BMI ) percentile of 99.2 ( s.d.=0.7 ) completed assessment s at baseline and 6- , 12- , and 18 months post-r and omization . A parent or guardian also participated . Child psychological symptoms , including binge eating , were measured before r and omization using self-report question naires . Child height and weight were measured at baseline , 6- , 12- , and 18 months . The primary study outcome was percent overweight ( that is , percent over median BMI for age and sex ) . Results : Twenty-two children ( 11.5 % ) endorsed binge eating at baseline ( Binge Eating Group ) . Children in the Binge Eating Group were younger and had more depressive , anxiety , and eating disorder symptoms , and lower self-esteem than children in the rest of the sample ( No Binge Eating Group ) . There also were differences between the Binge Eating and No Binge Eating groups with respect to the short-term effects of treatment group assignment on change in percent overweight during the study . Specifically , improvements in percent overweight in the intervention condition relative to usual care were documented in the No Binge Eating Group only . Among children in the Binge Eating Group , those assigned to intervention showed a 2.6 % increase in percent overweight , on average , at the completion of acute treatment as compared to an 8.5 % decrease among children without binge eating . However , these effects were not maintained during follow-up . Conclusion : Results of this study suggest the importance of considering binge eating in the development of weight management programs for severely obese youth OBJECTIVES The objectives of this pilot study were to compare the dietary , physiological and metabolic effects of 12-week modified carbohydrate nutrition intervention when disseminated in an individualized home-based format versus a group classroom-based format . METHODS Twenty-three overweight ( > /=85(th ) percentile BMI ) Latina adolescent females ( 12 - 17 years of age ) were r and omized to a 12-week modified carbohydrate dietary intervention delivered in either an individualized home-based format ( n = 11 ) or a group classroom-based format ( n = 12 ) . Anthropometrics , dietary intake by 3-day diet records , insulin dynamics by extended 3-hour Oral Glucose Tolerance test ( OGTT ) and body composition by Dual energy X-ray absorptiometry ( DXA ) were measured before and after intervention ; 24-hour diet recalls were collected once or twice per month throughout the program . RESULTS Mixed modeling showed no significant differences in changes in dietary intake between intervention groups , but both groups significantly reduced intake of added sugar , sugary beverages and refined carbohydrates by 33 % , 66 % , and 35 % , respectively , and dietary fiber significantly increased by 44 % ( p < 0.01 ) throughout the 12 weeks . There was a significant time effect for BMI z-scores within each intervention group ( p < 0.05 ) . There was no significant time*intervention group interaction for any of the physiological or metabolic variables , indicating that change over time was not significantly different between intervention groups . CONCLUSIONS Although a culturally tailored , modified carbohydrate dietary intervention led to significant improvements in dietary intake and BMI z-scores , the extremely intensive , individualized , home-based program was no more effective at improving diet , decreasing adiposity or reducing type 2 diabetes risk factors than the traditional classroom-based format OBJECTIVE : To determine whether a 2-year family-based intervention using frequent contact and limited expert involvement was effective in reducing excessive weight compared with usual care . METHODS : Two hundred and six overweight and obese ( BMI ≥85th percentile ) children aged 4 to 8 years were r and omized to usual care ( UC ) or tailored package ( TP ) sessions at university research rooms . UC families received personalized feedback and generalized advice regarding healthy lifestyles at baseline and 6 months . TP families attended a single multidisciplinary session to develop specific goals suitable for each family , then met with a mentor each month for 12 months , and every third month for another 12 months to discuss progress and provide support . Outcome measurements ( anthropometry , question naires , dietary intake , accelerometry ) were obtained at 0 , 12 , and 24 months . RESULTS : BMI at 24 months was significantly lower in TP compared with UC children ( difference , 95 % confidence interval : –0.34 , –0.65 to –0.02 ) , as was BMI z score ( –0.12 , –0.20 to –0.04 ) and waist circumference ( –1.5 , –2.5 to –0.5 cm ) . TP children consumed more fruit and vegetables ( P = .038 ) and fewer noncore foods ( P = .020 ) than UC children , and fewer noncore foods were available in the home ( P = .002 ) . TP children were also more physically active ( P = .035 ) . No differences in parental feeding practice s , parenting , quality of life , child sleep , or behavior were observed . CONCLUSIONS : Frequent , low-dose support was effective for reducing excessive weight in predominantly mild to moderately overweight children over a 2-year period . Such initiatives could feasibly be incorporated into primary care Objective American Indian children of pre-school age have disproportionally high obesity rates and consequent risk for related diseases . Healthy Children , Strong Families was a family-based r and omized trial assessing the efficacy of an obesity prevention toolkit delivered by a mentor v. mailed delivery that was design ed and administered using community-based participatory research approaches . Design During Year 1 , twelve healthy behaviour toolkit lessons were delivered by either a community-based home mentor or monthly mailings . Primary outcomes were child BMI percentile , child BMI Z-score and adult BMI . Secondary outcomes included fruit/vegetable consumption , sugar consumption , television watching , physical activity , adult health-related self-efficacy and perceived health status . During a maintenance year , home-mentored families had access to monthly support groups and all families received monthly newsletters . Setting Family homes in four tribal communities , Wisconsin , USA . Subjects Adult and child ( 2–5-year-olds ) dyads ( n 150 ) . Results No significant effect of the mentored v. mailed intervention delivery was found ; however , significant improvements were noted in both groups exposed to the toolkit . Obese child participants showed a reduction in BMI percentile at Year 1 that continued through Year 2 ( P<0·05 ) ; no change in adult BMI was observed . Child fruit/vegetable consumption increased ( P=0·006 ) and mean television watching decreased for children ( P=0·05 ) and adults ( P=0·002 ) . Reported adult self-efficacy for health-related behaviour changes ( P=0·006 ) and quality of life increased ( P=0·02 ) . Conclusions Although no effect of delivery method was demonstrated , toolkit exposure positively affected adult and child health . The intervention was well received by community partners ; a more comprehensive intervention is currently underway based on these findings Background Family meal frequency has been shown to be strongly associated with better dietary intake ; however , associations with weight status have been mixed . Family meals-focused r and omized controlled trials with weight outcomes have not been previously conducted . Therefore , this study purpose was to describe weight-related outcomes of the HOME Plus study , the first family meals-focused r and omized controlled trial to prevent excess weight gain among youth . Methods Families ( n = 160 8 - 12-year-old children and their parents/guardians ) were r and omized to intervention ( n = 81 ) or control ( n = 79 ) groups . Data were collected at baseline ( 2011–2012 ) , post-intervention ( 12-months post-baseline ) and follow-up ( 21-months post-baseline ) . The intervention included ten monthly group sessions ( nutrition education ; h and s-on meal and snack planning , preparation , and skill development ; screen time reductions ) and five motivational , goal - setting phone calls . The main outcome was child body mass index ( BMI ) z-score . Results General linear models , adjusted for baseline values and demographics , showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up ; however , a promising reduction in excess weight gain was observed . Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts . Conclusions The study used a strong theoretical framework , rigorous design , quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention . It showed a modest decrease in excess weight gain . The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children , although more research with appropriately powered sample s are needed to replicate this finding . Trial registration This study is registered at www . clinical trials.gov NCT01538615 . Registered 01/17/2012 Background Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life . Therefore , early intervention is critical . This paper describes the rationale , design , methodology , and sample characteristics of a 5-year cluster r and omized controlled trial being conducted in eight elementary schools in rural North Carolina , United States . Methods / Design The first aim of the trial is to examine the effects of a two-phased intervention on weight status , adiposity , nutrition and exercise health behaviors , and self-efficacy in overweight or obese 2nd , 3 rd , and 4th grade children and their overweight or obese parents . The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months . The primary outcome in parents is a decrease in BMI from baseline to 18 months . Secondary outcomes for both children and parents include adiposity , nutrition and exercise health behaviors , and self-efficacy from baseline to 18 months . A secondary aim of the trial is to examine in the experimental group , the relationships between parents and children 's changes in weight status , adiposity , nutrition and exercise health behaviors , and self-efficacy . An exploratory aim is to determine whether African American , Hispanic , and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status , adiposity , health behaviors , and self-efficacy . A total of 358 African American , non-Hispanic white , and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m2 have been inducted over 3 1/2 years and r and omized by cohort to either an experimental or a wait-listed control group . The experimental group receives a 12-week intensive intervention of nutrition and exercise education , coping skills training and exercise ( Phase I ) , 9 months of continued monthly contact ( Phase II ) and then 6 months ( follow-up ) on their own . Safety endpoints include adverse event reporting . Intention-to-treat analysis will be applied to all data . Discussion Findings from this trial may lead to an effective intervention to assist children and parents to work together to improve nutrition and exercise patterns by making small lifestyle pattern changes . Trial registration NCT01378806 To assess the feasibility of conducting empirically supported family-based paediatric obesity group treatment via TeleMedicine . Seventeen families were r and omly assigned to one of two conditions ( physician visit , TeleMedicine ) . Measures included feasibility , satisfaction and intervention outcome measures such as BMI percentile , and nutrition and activity behaviours . Measures were completed at baseline , post-treatment and at 1-year follow-up . Analyses indicate that both feasibility and satisfaction data regarding the TeleMedicine intervention were positive . Intervention outcome indicates no change in BMI percentile or nutrition and activity behaviours for either treatment group . A behavioural family-based weight loss intervention delivered via TeleMedicine was well received by both parents and providers . Due to the small sample size , null findings regarding intervention outcome should be interpreted with caution . Future research should focus on methods to increase the impact of this intervention on key outcome variables BACKGROUND Given the dramatic increase in adolescent overweight and obesity , models are needed for implementing weight management treatment through readily accessible venues . We evaluated the acceptability and efficacy of a school-based intervention consisting of school nurse-delivered counseling and an afterschool exercise program in improving diet , activity , and body mass index ( BMI ) among overweight and obese adolescents . METHODS A pair-matched cluster-r and omized controlled school-based trial was conducted in which 8 public high schools were r and omized to either a 12-session school nurse-delivered cognitive-behavioral counseling intervention plus school-based after school exercise program , or 12-session nurse contact with weight management information ( control ) . Overweight or obese adolescents ( N = 126 ) completed anthropometric and behavioral assessment s at baseline and 8-month follow-up . Main outcome measures included diet , activity , and BMI . Mixed effects regression models were conducted to examine differences at follow-up . RESULTS At follow-up , students in intervention compared with control schools were not different in BMI , percent body fat , and waist circumference . Students reported eating breakfast ( adjusted mean difference 0.81 days ; 95 % confidence interval [ CI ] 0.11 - 1.52 ) on more days/week ; there were no differences in other behaviors targeted by the intervention . CONCLUSIONS While a school-based intervention including counseling and access to an after-school exercise program is theoretically promising with public health potential , it was not effective in reducing BMI or key obesogenic behaviors . Our findings are important in highlighting that interventions targeted at the individual level are not likely to be sufficient in addressing the adolescent obesity epidemic without changes in social norms and the environment Children with migration background ( MB ) appear to be at higher risk of developing obesity , therefore , prevention is necessary to avoid possible health inequalities . This study investigated a 1-year intervention with focus on increasing physical activity ( PA ) and fruit and vegetable intake ( FVI ) , decreasing screen media use ( SMU ) and soft drink consumption ( SDC ) in children with MB . 525 children ( 7.1 ± 0.7 years ) with MB who participated in the cluster-r and omised study were assessed at baseline and after 1 year . Daily SMU , PA behaviours , SDC and FVI were assessed using a parental question naire . After one year , significant effects were found in the intervention group for FVI ( p ≤ 0.035 ) . Partially strong tendencies but no significant differences were found for PA and SDC . Although the effects are small , the intervention seems to reach children with MB . An intervention lasting longer than one year might result in more changes Background : Treatment of childhood obesity is difficult , and successful management may differ in various areas with different cultural background s. The present study was conducted to assess the effect of lifestyle modification family-based intervention in young Iranian children . Methods : This field trial study was conducted in 2011 among 156 obese children in Tehran , Iran . They were r and omly assigned to intervention and control groups . At baseline , anthropometric measurements and biochemical analysis were performed . The second and third phases consisted of training sessions for parents of the intervention group . At the fourth phase , there was no training program . In all four phases , question naires on demographic characteristics , lifestyle and food frequency were completed by interviewing with mothers , and biochemical analysis was repeated at the end of the study . Results : During the second and third phases of the study , weight and height increased significantly in both groups , although weight increased more slowly , and waist and hip circumferences was decreased in the intervention group . Serum triglycerides and cholesterol decreased significantly in the intervention group ( P < 0.05 ) . Analysis of food group consumption showed that in the intervention group , not only consumption of milk , dairy and nuts group increased significantly but also the corresponding figure decreased for bread and cereals , sugar and confectionery ingredients ; moreover , the family 's oil and fat consumption decreased significantly ( P < 0.05 ) . Watching TV and playing on the computer decreased significantly in the intervention group ; however , walking time increased significantly in both groups ( P < 0.05 ) . Conclusions : The family-based lifestyle program had limited but desirable effects on anthropometric and metabolic outcomes of the obese children . We suggest that a longer period of intervention may have more favorable results BACKGROUND Effective programmes to help children manage their weight are required . ' Families for Health ' focuses on a parenting approach , design ed to help parents develop their parenting skills to support lifestyle change within the family . Families for Health version 1 showed sustained reductions in mean body mass index ( BMI ) z-score after 2 years in a pilot project . OBJECTIVE The aim was to evaluate its effectiveness and cost-effectiveness in a r and omised controlled trial ( RCT ) . DESIGN The trial was a multicentre , investigator-blind RCT , with a parallel economic and process evaluation , with follow-up at 3 and 12 months . R and omisation was by family unit , using a 1 : 1 allocation by telephone registration , stratified by three sites , with a target of 120 families . SETTING Three sites in the West Midl and s , Engl and , UK . PARTICIPANTS Children aged 6 - 11 years who were overweight ( ≥ 91st centile BMI ) or obese ( ≥ 98th centile BMI ) , and their parents/carers . Recruitment was via referral or self-referral . INTERVENTIONS Families for Health version 2 is a 10-week , family-based community programme with parallel groups for parents and children , addressing parenting , lifestyle , social and emotional development . Usual care was the treatment for childhood obesity provided within each locality . MAIN OUTCOME MEASURES Joint primary outcome measures were change in children 's BMI z-score and incremental cost per quality -adjusted life-year ( QALY ) gained at 12 months ' follow-up ( QALYs were calculated using the European Quality of Life-5 Dimensions Youth version ) . Secondary outcome measures included changes in children 's waist circumference , percentage body fat , physical activity , fruit/vegetable consumption and quality of life . Parents ' BMI and mental well-being , family eating/activity , parent-child relationships and parenting style were also assessed . The process evaluation documented recruitment , reach , dose delivered , dose received and fidelity , using mixed methods . RESULTS The study recruited 115 families ( 128 children ; 63 boys and 65 girls ) , with 56 families r and omised to the Families for Health arm and 59 to the ' usual-care ' control arm . There was 80 % retention of families at 3 months ( Families for Health , 46 families ; usual care , 46 families ) and 72 % retention at 12 months ( Families for Health , 44 families ; usual care , 39 families ) . The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [ 0.114 , 95 % confidence interval ( CI ) -0.001 to 0.229 ; p = 0.053 ] . However , within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm ( -0.118 , 95 % CI -0.203 to -0.034 ; p = 0.007 ) , but not in the Families for Health arm ( -0.005 , 95 % CI -0.085 to 0.078 ; p = 0.907 ) . There was only one significant difference between groups for secondary outcomes . The economic evaluation , taking a NHS and Personal Social Services perspective , showed that mean costs 12 months post r and omisation were significantly higher for Families for Health than for usual care ( £ 998 vs. £ 548 ; p < 0.001 ) . The mean incremental cost-effectiveness of Families for Health was estimated at £ 552,175 per QALY gained . The probability that the Families for Health programme is cost-effective did not exceed 40 % across a range of thresholds . The process evaluation demonstrated that the programme was implemented , as planned , to the intended population and any adjustments did not deviate widely from the h and book . Many families waited more than 3 months to receive the intervention . Facilitators ' , parents ' and children 's experiences of Families for Health were largely positive and there were no adverse events . Further analysis could explore why some children show a clinical ly significant benefit while others have a worse outcome . CONCLUSIONS Families for Health was neither effective nor cost-effective for the management of obesity in children aged 6 - 11 years , in comparison with usual care . Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted , focusing on children who had a clinical ly significant benefit and those who showed a worse outcome with treatment . Further research could focus on the role of parents in the prevention of obesity , rather than treatment . TRIAL REGISTRATION Current Controlled Trials IS RCT N45032201 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 21 , No. 1 . See the NIHR Journals Library website for further project information Background : One of the basic principles of behavioral economics interventions is identification of alternative behaviors to compete with the reinforcing value of a highly rewarding commodity . Purpose : Two experiments that attempt to increase alternatives to eating in obese youth are presented . Methods : A r and omized , controlled trial was used in Study 1 to compare a comprehensive family-based behavioral treatment program or an experimental treatment that incorporated reinforcing children for engaging in alternative behaviors to eating for 41 overweight 8-to 12-year-old children . Study 2 used a within-subject design with baseline , enriched environment and a second baseline phase to determine the influence of providing activities that compete with eating for 13 overweight 8-to 12-year-old children . Measurements included body mass index ( BMI ) change , alternatives to eating , eating , and physical activity . Results : In Study I both treatments were associated with significant ( p < .05 ) and maintained reductions in z- BMI over the 24 months of observation . The experimental group showed a significantly ( p < .05 ) greater increase in alternatives to eating , and both groups showed significant ( p < .05 ) increases in physical activity . In Study 2 alternative behaviors to eating were increased by almost I hr/day ( p < .001 ) but were not associated with significant changes in energy intake or physical activity . Conclusion : These results suggest that using the methods studied , increasing behaviors that could compete with eating did not influence relative weight in a clinical outcome study or energy intake in a controlled field study BACKGROUND Sedentary activities such as video gaming are independently associated with obesity . Active video games , in which players physically interact with images on screen , may help increase physical activity and improve body composition . OBJECTIVE The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight , body composition , physical activity , and physical fitness . DESIGN We conducted a 2-arm , parallel , r and omized controlled trial in Auckl and , New Zeal and . A total of 322 overweight and obese children aged 10 - 14 y , who were current users of sedentary video games , were r and omly assigned at a 1:1 ratio to receive either an active video game up grade package ( intervention , n = 160 ) or to have no change ( control group , n = 162 ) . The primary outcome was the change from baseline in body mass index ( BMI ; in kg/m(2 ) ) . Secondary outcomes were changes in percentage body fat , physical activity , cardiorespiratory fitness , video game play , and food snacking . RESULTS At 24 wk , the treatment effect on BMI ( -0.24 ; 95 % CI : -0.44 , -0.05 ; P = 0.02 ) favored the intervention group . The change ( ±SE ) in BMI from baseline increased in the control group ( 0.34 ± 0.08 ) but remained the same in the intervention group ( 0.09 ± 0.08 ) . There was also evidence of a reduction in body fat in the intervention group ( -0.83 % ; 95 % CI : -1.54 % , -0.12 % ; P = 0.02 ) . The change in daily time spent playing active video games at 24 wk increased ( 10.03 min ; 95 % CI : 6.26 , 13.81 min ; P < 0.0001 ) with the intervention accompanied by a reduction in the change in daily time spent playing nonactive video games ( -9.39 min ; 95 % CI : -19.38 , 0.59 min ; P = 0.06 ) . CONCLUSION An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children . This trial was registered in the Australian New Zeal and Clinical Trials Registry at http://www.anzctr.org.au/ as ACTRN12607000632493 Objective The objective of the current study was to examine the feasibility of telemedicine vs. telephone for the delivery of a multidisciplinary weekly family-based behavioural group intervention to treat paediatric obesity delivered to families living in rural areas using a r and omized controlled trial methodology . Methods 103 rural children and their families were recruited . Feasibility measures included participant satisfaction , session attendance and retention . Treatment outcome measures included child Body Mass Index z-score ( BMI z ) , parent BMI , 24-hour dietary recalls , accelerometer data , the child behavior checklist and the behavioral pediatrics feeding assessment scale . Results Participants were highly satisfied with the intervention both via telemedicine and via telephone . Completion rates were much higher than for other paediatric obesity intervention programmes , and both method ologies were highly feasible . There were no differences in telemedicine and telephone groups on primary outcomes . Conclusion Both telemedicine and telephone intervention appear to be feasible and acceptable methods of delivering paediatric obesity treatment to rural children BACKGROUND Cognitive behavioral therapy ( CBT ) teaches behavioral and cognitive strategies that focus on achieving and maintaining lifestyle changes . OBJECTIVE We examined the effectiveness of a CBT program ( CHOOSE HEALTH ) for improving body composition , diet , and physical activity in overweight and obese adolescents . DESIGN Adolescents [ 16 male , 31 female ; aged 14.5 + /- 1.6 y ; body mass index ( BMI ; in kg/m(2 ) ) 30.9 + /- 4.2 ] were block-matched into 2 groups by age , sex , Tanner stage , BMI , and hip and waist circumferences and were r and omly assigned to CBT or no treatment ( control ) . CBT consisted of 10 weekly sessions , followed by 5 fortnightly telephone sessions . RESULTS Compared with the control , over 20 wk , CBT improved ( significant group x time interactions ) BMI ( CBT , -1.3 + /- 0.4 ; control , 0.3 + /- 0.3 ; P = 0.007 ) , weight ( CBT , -1.9 + /- 1.0 kg ; control , 3.8 + /- 0.9 kg ; P = 0.001 ) , body fat ( CBT , -1.5 + /- 0.9 kg ; control , 2.3 + /- 1.0 kg ; P = 0.001 ) , and abdominal fat ( CBT , -124.0 + /- 46.9 g ; control , 50.1 + /- 53.5 g ; P = 0.008 ) . CBT showed a greater reduction in intake of sugared soft drinks as a percentage of total energy ( CBT , -4.0 + /- 0.9 % ; control , -0.3 + /- 0.9 % ; P = 0.005 for group x time interaction ) , which was related to reductions in weight ( r = 0.48 , P = 0.04 ) , BMI ( r = 0.53 , P = 0.02 ) , and waist circumference ( r = 0.54 , P = 0.02 ) . Physical activity did not change significantly . CONCLUSIONS A 10-wk CBT program followed by 10 wk of fortnightly phone contact improved body composition in overweight and obese adolescents . Changes in soft drink consumption may have contributed to this benefit BACKGROUND Excessive weight in childhood is a serious public health concern because of its costly health consequences and its increasing prevalence . OBJECTIVE Our objective was to compare the efficacy of a family-based approach for the treatment of childhood obesity , in which the parents served as the exclusive agents of change , with that of the conventional approach , in which the children served as the agents of change . DESIGN This study had a r and omized , longitudinal prospect i ve design and lasted 1 y. Sixty obese children aged 6 - 11 y were r and omly allocated to the experimental ( parents as agents of change ) or control ( children as agents of change ) group . Anthropometric and biochemical measurements were determined at the start and end of the study . A sociodemographic question naire and a family eating and activity habits question naire were completed by both parents . Hour-long support and educational sessions were conducted by a clinical dietitian : 14 sessions for the parents in the experimental group and 30 sessions for the children in the control group . RESULTS The dropout rate was nine times greater in the control group ( n = 9 ) than in the experimental group ( n = 1 ) . Mean percentile weight reduction was significantly ( P < 0.03 ) higher in children in the experimental group ( 14.6 % ) than in the control group ( 8.1 % ) . CONCLUSIONS Treatment of childhood obesity with parents as the exclusive agents of change was superior to the conventional approach , as indicated by the dropout rate and the percentage weight loss of the children during the 1-y intervention Background There is a need to develop sustainable and clinical ly effective weight management interventions that are suitable for delivery in community setting s where the vast majority of overweight and obese adolescents should be treated . This study aims to evaluate the effect of additional therapeutic contact as an adjunct to the Loozit ® group program – a community-based , lifestyle intervention for overweight and lower grade obesity in adolescents . The additional therapeutic contact is provided via telephone coaching and either mobile phone Short Message Service or electronic mail , or both . Methods and design The study design is a two-arm r and omised controlled trial that aims to recruit 168 overweight and obese 13–16 year olds ( Body Mass Index z-score 1.0 to 2.5 ) in Sydney , Australia . Adolescents with secondary causes of obesity or significant medical illness are excluded . Participants are recruited via schools , media coverage , health professionals and several community organisations . Study arm one receives the Loozit ® group weight management program ( G ) . Study arm two receives the same Loozit ® group weight management program plus additional therapeutic contact ( G+ATC ) . The ' G ' intervention consists of two phases . Phase 1 involves seven weekly group sessions held separately for adolescents and their parents . This is followed by phase 2 that involves a further seven group sessions held regularly , for adolescents only , until two years follow-up . Additional therapeutic contact is provided to adolescents in the ' G+ATC ' study arm approximately once per fortnight during phase 2 only . Outcome measurements are assessed at 2 , 12 and 24 months post-baseline and include : BMI z-score , waist z-score , metabolic profile indicators , physical activity , sedentary behaviour , eating patterns , and psychosocial well-being . Discussion The Loozit ® study is the first r and omised controlled trial of a community-based adolescent weight management intervention to incorporate additional therapeutic contact via a combination of telephone coaching , mobile phone Short Message Service , and electronic mail . If shown to be successful , the Loozit ® group weight management program with additional therapeutic contact has the potential to be readily translatable to a range of health care setting s . Trial registration The protocol for this study is registered with the Australian Clinical Trials Registry ( ACTRNO12606000175572 ) There is a consensus that interventions to prevent and treat childhood obesity should involve the family ; however , the extent of the child 's involvement has received little attention . The goal of the present study was to evaluate the relative efficacy of treating childhood obesity via a family-based health-centred intervention , targeting parents alone v. parents and obese children together . Thirty-two families with obese children of 6 - 11 years of age were r and omised into groups , in which participants were provided for 6 months a comprehensive educational and behavioural programme for a healthy lifestyle . These groups differed in their main agent of change : parents-only v. the parents and the obese child . In both groups , parents were encouraged to foster authoritative parenting styles ( parents are both firm and supportive ; assume a leadership role in the environmental change with appropriate granting of child 's autonomy ) . Only the intervention aim ed at parents-only result ed in a significant reduction in the percentage overweight at the end of the programme ( P=0.02 ) as well as at the 1-year follow-up meeting . The differences between groups at both times were significant ( P<0.05 ) . A greater reduction in food stimuli in the home ( P<0.05 ) was noted in the parents-only group . In both groups , the parents ' weight status did not change . Regression analysis shows that the level of attendance in sessions explained 28 % of the variability in the children 's weight status change , the treatment group explained another 10 % , and the improvement in the obesogenic load explained 11 % of the variability . These results suggest that omitting the obese child from active participation in the health-centred programme may be beneficial for weight loss and for the promotion of a healthy lifestyle among obese children OBJECTIVE : To evaluate the effectiveness of active parental involvement in a lifestyle intervention for the management of childhood obesity . DESIGN : Forty-two overweight children ( 32 girls and 10 boys ) , aged 9.2±0.2 years and with percent overweight 39.8±2.7 % , were r and omly allocated either to a child- and -parent group ( N = 23 ) or a child-alone group ( N = 19 ) . Both groups attended a 3-month multidisciplinary program extended by booster sessions during follow-up , which involved many cognitive behavioral therapy principles and assigned high self-regulation to the children , but differed in parental involvement . Percent overweight was evaluated at baseline , and at 3 , 6 , and 18 months thereafter . RESULTS : There was no significant interaction between time and group or a significant difference between groups . Percent overweight decreased by 4.9±1.4 at 18 months ( p < 0.001 ) ; the reduction occurred during the active phase of the treatment ( 0 - 3 months ) and was maintained thereafter . CONCLUSION : In the setting of the present study , the active parental involvement did not significantly modify the results of lifestyle interventions for children ’s overweight management This study evaluated the feasibility of a home-based intervention to reduce sugar-sweetened beverage intake and television viewing among children . Lower income parents of overweight children aged 5 - 12 years ( n = 40 ) were r and omized to a home environment intervention to reduce television viewing with locking devices and displace availability of sugar-sweetened beverages with home delivery of non-caloric beverages ( n = 25 ) , or to a no-intervention control group ( n = 15 ) for 6 months . Data were collected at baseline and 6 months . After 6 months , television viewing hours per day was significantly lower in the intervention group compared with the control group ( 1.7 [ SE = .02 ] vs. 2.6 [ SE = .25 ] hours/day , respectively , P < .01 ) . Sugar-sweetened beverage intake was marginally significantly lower among intervention group compared to control group children ( 0.21 [ SE = .09 ] vs. 0.45 [ SE = .10 ] , respectively , P < .09 ) . Body mass index ( BMI ) z-score was not significantly lower among intervention compared to control children . Among a lower income sample of children , a home-based intervention reduced television viewing , but not sugar-sweetened beverage intake or BMI z-score Background Obesity is mainly attributed to environmental factors . In developed countries , the time spent on physical activity tasks is decreasing , whereas sedentary behaviour patterns are increasing . The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention ( Nereu programme ) and compared it to counselling intervention such as a health centre intervention programme for the management of children ’s obesity . Methods / Design The study design is a r and omized controlled multicenter clinical trial using two types of interventions : Nereu and Counselling . The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention . This programme is based on a multidisciplinary intervention consisting of 4 components : physical activity sessions for children , family theoretical and practical sessions for parents , behaviour strategy sessions involving both , parents and children , and lastly , weekend extra activities for all . Counselling is offered to the family in the form of a monthly physical health and eating habits session . Participants will be recruited according the following criteria : 6 to 12 year-old-children , referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile ( less than 2 hours per week of physical activity ) , they must live in or near the municipality of Lleida ( Spain ) and their healthcare paediatric unit must have previously accepted to cooperate with this study . The following variables will be evaluated : a ) cardiovascular risk factors ( anthropometric parameters , blood test and blood pressure ) , b ) sedentary and physical activity behaviour and dietary intake , c ) psychological aspects d ) health related quality of life ( HRQOL ) , e ) cost-effectiveness of the intervention in relation to HRQOL . These variables will be then be evaluated 4 times longitudinally : at baseline , at the end of the intervention ( 8 months later ) , 6 and 12 months after the intervention . We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups . Discussion This trial will provide new evidence for the long-term effects of childhood obesity management , as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres . Trial registration Clinical Trials.gov , Importance Novel approaches to care delivery that leverage clinical and community re sources could improve body mass index ( BMI ) and family-centered outcomes . Objective To examine the extent to which 2 clinical -community interventions improved child BMI z score and health-related quality of life , as well as parental re source empowerment in the Connect for Health Trial . Design , Setting , and Participants This 2-arm , blinded , r and omized clinical trial was conducted from June 2014 through March 2016 , with measures at baseline and 1 year after r and omization . This intent-to-treat analysis included 721 children ages 2 to 12 years with BMI in the 85th or greater percentile from 6 primary care practice s in Massachusetts . Interventions Children were r and omized to 1 of 2 arms : ( 1 ) enhanced primary care ( eg , flagging of children with BMI ≥ 85th percentile , clinical decision support tools for pediatric weight management , parent educational material s , a Neighborhood Re source Guide , and monthly text messages ) or ( 2 ) enhanced primary care plus context ually tailored , individual health coaching ( twice-weekly text messages and telephone or video contacts every other month ) to support behavior change and linkage of families to neighborhood re sources . Main Outcomes and Measures One-year changes in age- and sex-specific BMI z score , child health-related quality of life measured by the Pediatric Quality of Life 4.0 , and parental re source empowerment . Results At 1 year , we obtained BMI z scores from 664 children ( 92 % ) and family-centered outcomes from 657 parents ( 91 % ) . The baseline mean ( SD ) age was 8.0 ( 3.0 ) years ; 35 % were white ( n = 252 ) , 33.3 % were black ( n = 240 ) , 21.8 % were Hispanic ( n = 157 ) , and 9.9 % were of another race/ethnicity ( n = 71 ) . In the enhanced primary care group , adjusted mean ( SD ) BMI z score was 1.91 ( 0.56 ) at baseline and 1.85 ( 0.58 ) at 1 year , an improvement of −0.06 BMI z score units ( 95 % CI , −0.10 to −0.02 ) from baseline to 1 year . In the enhanced primary care plus coaching group , the adjusted mean ( SD ) BMI z score was 1.87 ( 0.56 ) at baseline and 1.79 ( 0.58 ) at 1 year , an improvement of −0.09 BMI z score units ( 95 % CI , −0.13 to −0.05 ) . However , there was no significant difference between the 2 intervention arms ( difference , −0.02 ; 95 % CI , −0.08 to 0.03 ; P = .39 ) . Both intervention arms led to improved parental re source empowerment : 0.29 units ( 95 % CI , 0.22 to 0.35 ) higher in the enhanced primary care group and 0.22 units ( 95 % CI , 0.15 to 0.28 ) higher in the enhanced primary care plus coaching group . Parents in the enhanced primary care plus coaching group , but not in the enhanced care alone group , reported improvements in their child ’s health-related quality of life ( 1.53 units ; 95 % CI , 0.51 to 2.56 ) . However , there were no significant differences between the intervention arms in either parental re source empowerment ( 0.07 units ; 95 % CI , −0.02 to 0.16 ) or child health-related quality of life ( 0.89 units ; 95 % CI , −0.56 to 2.33 ) . Conclusions and Relevance Two interventions that included a package of high- quality clinical care for obesity and linkages to community re sources result ed in improved family-centered outcomes for childhood obesity and improvements in child BMI . Trial Registration clinical trials.gov Identifier : To assess the effectiveness of a 12-week school-based educational preventive programme for type 2 diabetes by change in weight and fasting blood glucose level in Jordanian adolescents . Sixteen percent of Jordanian adults have obesity-related type 2 diabetes and 5.6 % of obese adolescents examined , however one-third unexamined . Rates in Arabic countries will double in 20 years , but this can be prevented and reversed by controlling obesity . A single-blinded r and omized controlled trial was conducted in 2 unisex high schools in Irbid , Jordan , in 2012 . Intervention and control participants , aged 12 to 18 years , were visibly overweight/obese . They were r and omly allocated to the intervention ( n = 205 ) or control ( n = 196 ) groups . At-risk students were assessed before and after the 12-week intervention , for change in weight and fasting blood glucose level following preventive instruction and parent-supported changes . Mean age of participants was 15.3 years with equal percentages of both males ( 49.4 % ) and females . Post intervention , the intervention group , demonstrated statistically significant reductions : mean difference of 3.3 kg in weight ( P < .000 ) and 1.36 mg/dL ( 0.075 mmol/L ) in fasting blood glucose ( P < .000 ) . School-based early prevention intervention effectively reduced weight and fasting blood glucose in Jordanian at-risk adolescents AIM To determine whether five months of guided active play in overweight or obese children and adolescents under multi-disciplinary management for weight reduction leads to increased physical activity levels in leisure time , as well as changes in aerobic fitness and body composition . METHODS Sixty overweight or obese children and adolescents were r and omly assigned to an intervention or control group . All participants received dietary advice and were encouraged to increase physical activity level . The intervention group additionally participated in 60-minute guided active play/physical activity twice a week for 5 months . Physical activity was recorded ; aerobic fitness and body composition were measured at inclusion and after cessation of intervention . RESULTS Physical activity level during weekend days was significantly higher for the intervention group compared with the controls after 5 months intervention ( p=0.04 ) . The mean reduction in percentage of body fat was 1.8 % ( 95%CI : 0.6 , 3.1 ) in the intervention group ( p=0.04 ) and not significant among the controls ( 0.9 [ -0.9 , 2.7 ] ) . There was no change in aerobic fitness . CONCLUSION Five months of guided active play was associated with increased physical activity levels during weekend days and reduced body fat , although weakly , in overweight and obese children and adolescents participating in multi-disciplinary weight reduction programmes This study tested the impact of a multicomponent intervention entitled " Partners of all Ages Reading About Diet and Exercise " ( PARADE ) a child-focused energy balance intervention incorporated into mentoring programs . We used a group r and omized nested cohort design r and omizing mentoring program sites ( n = 119 ) and children ( N = 782 ; females = 49 % ; African American = 37 % ; mean ( s.d . ) age = 8.5 ( 1.5 ) years ) to intervention or usual care conditions . PARADE mentors delivered eight lesson plans addressing key concepts related to diet and activity ; eight child-focused computer-tailored storybooks with messages targeting that child 's diet and activity patterns and eight parent action support newsletters . When compared to the control group , PARADE children were more knowledgeable of diet and activity guidelines ( P < 0.01 ) , challenged themselves more to eat five fruits and vegetables ( FV ) ( P < 0.01 ) and be active 1 h daily ( P < 0.01 ) , and to ask for FV for snack ( P = 0.015 ) . Calories from high fat foods decreased in overweight/obese children , but not for normal weight children ( P = 0.059 ) . There were no significant differences in fruit and vegetable intake , total calories , percent time being active , or BMI z-score . The combination of one-to-one mentoring , child-focused computer based tailoring , and parent support may impact important behavioral change precursors in environments over which the child has control , especially among normal weight children . Further , work is needed to evaluate the impact of family-focused multicomponent interventions , including computer-tailored approaches , directed toward both the parent and the child BACKGROUND Parenting interventions have achieved changes in factors associated with childhood obesity but few have tested the effects on multiple parental influences . PURPOSE This study examined the efficacy of an intervention aim ed at improving several dimensions of parenting related to childhood obesity . DESIGN The study used a 2 x 2 factorial design . SETTING / PARTICIPANTS In 2003 , a sample of 13 Southern California schools was r and omized to one of four conditions : micro-environment only , macro-environment only , micro-plus-macro-environment , and no treatment control condition . Participants included 811 predominantly Mexican immigrant/Mexican-American mothers with children in kindergarten through second grade . INTERVENTION In both micro conditions , participants received monthly home visits by a promotora over a 7-month period plus monthly mailed newsletters . MAIN OUTCOME MEASURES In 2008 , intervention effects were examined on ( 1 ) parenting strategies , including limit setting , monitoring , discipline , control , and reinforcement related to children 's diet and physical activity ; ( 2 ) parental support for physical activity ; ( 3 ) parent-mediated family behaviors such as family meals eaten together and TV watching during family dinners ; and ( 4 ) perceived barriers and other parent cognitions related to children 's eating and activity . RESULTS At the 2-year follow-up , significant improvements were observed in three of five parenting strategies , parental support , and two of four parent-mediated family behaviors among parents receiving the micro intervention ( i.e. , those who received promotora visits and monthly newsletters ) , as compared with those in the macro-only and control conditions . CONCLUSIONS Aspects of parenting related to children 's risk for obesity and related health outcomes are modifiable with the support of a promotora and print media BACKGROUND / OBJECTIVES : The effect of changing one aspect of diet needs to be considered within the context of total diet . The study aim was to evaluate the changes in children ’s overall food intake following replacement of regular-fat with reduced-fat dairy foods . SUBJECTS/ METHODS : Secondary analysis of a cluster R and omized Controlled Trial where families were received parental behavioral nutrition education to change to reduced-fat dairy foods ( intervention ) or reduce screen time ( comparison control ) . Food intake was assessed via multiple 24-h recalls at baseline , week 12 ( end of the intervention ) and week 24 . Participants were parents and their children ( 4–13 years , N=145 ) who were regular-fat dairy food consumers . The intervention effect was based on mixed model analysis adjusted for covariates , and baseline food intake . RESULTS : At week 24 , total dairy servings per day were similar between groups and servings of reduced-fat dairy foods were higher in the intervention group ( 0.8 servings per day 95 % confidence interval ( CI ) 0.5–1.1 , P<0.0001 ) . Fruit intake was higher in the intervention group ( 0.5 servings per day 95 % CI 0.02–0.9 , P=0.040 ) , with no other statistically significant differences in food intake . In the intervention group , the contribution of core food groups to saturated fat intake was 45 % at baseline and 31 % at week 24 , with ‘ extra foods ’ being the largest contributor to total energy ( 28 % ) and saturated fat ( 40 % ) intake at follow-up . CONCLUSIONS : Changing children ’s dairy food choices to reduced-fat varieties did not adversely affect overall food intake . Replacing energy-dense foods with nutrient-rich foods should be the focus of interventions to lower in saturated fat Background Screen-based activities , such as watching television ( TV ) , playing video games , and using computers , are common sedentary behaviors among young people and have been linked with increased energy intake and overweight . Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child , small sample sizes , and short follow-up periods . The SWITCH ( Screen-Time Weight-loss Intervention Targeting Children at Home ) study aim ed to determine the effect of a home-based , family-delivered intervention to reduce screen-based sedentary behaviour on body composition , sedentary behaviour , physical activity , and diet over 24 weeks in overweight and obese children . Methods A two-arm , parallel , r and omized controlled trial was conducted . Children and their primary caregiver living in Auckl and , New Zeal and were recruited via schools , community centres , and word of mouth . The intervention , delivered over 20 weeks , consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content , which focused on training and educating them to use a wide range of strategies design ed to reduce their child ’s screen time . Families were given Time Machine TV monitoring devices to assist with allocating screen time , activity packages to promote alternative activities , online support via a website , and monthly newsletters . Control participants were given the intervention material on completion of follow-up . The primary outcome was change in children ’s BMI z-score from baseline to 24 weeks . Results Children ( n = 251 ) aged 9 - 12 years and their primary caregiver were r and omized to receive the SWITCH intervention ( n = 127 ) or no intervention ( controls ; n = 124 ) . There was no significant difference in change of z BMI between the intervention and control groups , although a favorable trend was observed ( -0.016 ; 95 % CI : -0.084 , 0.051 ; p = 0.64 ) . There were also no significant differences on secondary outcomes , except for a trend towards increased children ’s moderate intensity physical activity in the intervention group ( 24.3 min/d ; 95 % CI : -0.94 , 49.51 ; p = 0.06 ) . Conclusions A home-based , family-delivered intervention to reduce all leisure-time screen use had no significant effect on screen-time or on BMI at 24 weeks in overweight and obese children aged 9 - 12 years . Trial registration Australian New Zeal and Clinical Trials RegistryWebsite : http://www.anzctr.org.auTrial registration number : OBJECTIVE To test a 2-year community- and family-based obesity prevention program for low-income African American girls : Stanford GEMS ( Girls ' health Enrichment Multi-site Studies ) . DESIGN R and omized controlled trial with follow-up measures scheduled at 6 , 12 , 18 , and 24 months . SETTING Low-income areas of Oakl and , California . PARTICIPANTS African American girls aged 8 to 10 years ( N=261 ) and their parents or guardians . INTERVENTIONS Families were r and omized to one of two 2-year , culturally tailored interventions : ( 1 ) after-school hip-hop , African , and step dance classes and a home/family-based intervention to reduce screen media use or ( 2 ) information-based health education . MAIN OUTCOME MEASURE Changes in body mass index ( BMI ) . RESULTS Changes in BMI did not differ between groups ( adjusted mean difference [ 95 % confidence interval ] = 0.04 [ -0.18 to 0.27 ] per year ) . Among secondary outcomes , fasting total cholesterol level ( adjusted mean difference , -3.49 [ 95 % confidence interval , -5.28 to -1.70 ] mg/dL per year ) , low-density lipoprotein cholesterol level ( -3.02 [ -4.74 to -1.31 ] mg/dL per year ) , incidence of hyperinsulinemia ( relative risk , 0.35 [ 0.13 to 0.93 ] ) , and depressive symptoms ( -0.21 [ -0.42 to -0.001 ] per year ) decreased more among girls in the dance and screen time reduction intervention . In exploratory moderator analysis , the dance and screen time reduction intervention slowed BMI gain more than health education among girls who watched more television at baseline ( P = .02 ) and /or those whose parents or guardians were unmarried ( P = .01 ) . CONCLUSIONS A culturally tailored after-school dance and screen time reduction intervention for low-income , preadolescent African American girls did not significantly reduce BMI gain compared with health education but did produce potentially clinical ly important reductions in lipid levels , hyperinsulinemia , and depressive symptoms . There was also evidence for greater effectiveness in high-risk subgroups of girls The purpose of this article is to describe the study design , protocol , and baseline results of the " Healthy Habits , Healthy Girls " program . The intervention is being evaluated through a r and omized controlled trial in 10 public schools in the city of São Paulo , Brazil . Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months : body mass index , waist circumference , dietary intake , nutrition , physical activity , social cognitive mediators , physical activity level , sedentary behaviors , self-rated physical status , and overall self-esteem . According to the baseline results , 32.4 % and 23.4 % of girls were overweight in the intervention and control groups , respectively , and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time ( TV , computer , mobile devices ) . There were no significant differences between the groups for most of the variables , except age ( p = 0.000 ) and waist circumference ( p = 0.014 ) . The study showed a gap in the Brazilian literature on protocol s for r and omized controlled trials to prevent obesity among youth . The current study may thus be an important initial contribution to the field Background The childhood obesity epidemic is one of the foremost UK health priorities . Childhood obesity tracks into adult life and places individuals at considerable risk for diabetes , cardiovascular disease , liver disease and other morbidities . There is widespread need for paediatric lifestyle programmes as change may be easier to accomplish in childhood than later in life . Study Design / Method The study will evaluate the management of adolescent obesity by conducting a Medical Research Council complex intervention phase III efficacy r and omised clinical trial of the Healthy Eating Lifestyle Programme within primary care . The study tests a community delivered multi-component intervention design ed for adolescents developed from best practice as identified by National Institute for Health and Clinical Excellence . The hospital based pilot reduced body mass index and improved health-related quality of life . Subjects will be individually r and omised to receiving either the Healthy Eating Lifestyle Programme ( 12 fortnightly family sessions ) or enhanced st and ard care . Baseline and follow up assessment s will be undertaken blind to allocation status . A health economic evaluation is also being conducted.200 obese young people ( 13 - 17 years , body mass index > 98th centile for age and sex ) will be recruited from primary care within the greater London area . The primary hypothesis is that a motivational and solution-focused family-based weight management programme delivered over 6 months is more efficacious in reducing body mass index in obese adolescents identified in the community than enhanced st and ard care . The primary outcome will be body mass index at the end of the intervention , adjusted for baseline body mass index , age and sex . The secondary hypothesis is that the Healthy Eating Lifestyle Programme is more efficacious in improving quality of life and psychological function and reducing waist circumference and cardiovascular risk factors in obese adolescents than enhanced st and ard care assessed at 6 and 12 months post baseline assessment .Improvement in quality of life predicts on-going lifestyle change and maximises the chances of long-term weight reduction . We will explore whether improvement in QOL may be intermediate on the pathway between the intervention and body mass index change . Trial registration IS RCT N : IS RCT Objective : The purpose of this study was to test a two-phased nutrition and exercise education , coping skills training , and exercise intervention program for overweight or obese low-income ethnic minority 2nd to 4th grade children and their parents in rural North Carolina , USA . Methods : A cluster r and omized controlled trial was carried out with 358 children ( 7–10 years ) and a parent for each child ( n=358 ) . General linear mixed models were used to determine the effects of the intervention on weight , adiposity , health behaviors , and eating and exercise self-efficacy by examining changes in children and parents from baseline to completion of the study ( 18 months ) . Results : At 18 months , children in the experimental group did not have a significantly decreased body mass index ( BMI ) percentile ( P=0.470 ) ; however , they showed a reduction in the growth rate of their triceps ( P=0.001 ) and subscapular skinfolds ( P<0.001 ) and an improvement in dietary knowledge ( P=0.018 ) and drank less than one glass of soda per day ( P=0.052 ) compared with the control group . Parents in the experimental group had decreased BMI ( P=0.001 ) , triceps ( P<0.001 ) and subscapular skinfolds ( P<0.001 ) and increased nutrition ( P=0.003 ) and exercise ( P<0.001 ) knowledge and more often drank water or unsweetened drinks ( P=0.029 ) . At 18 months , children in the experimental group did not show significant improvement in eating ( P=0.956 ) or exercise self-efficacy ( P=0.976 ) . Experimental parents demonstrated improved socially acceptable eating self-efficacy ( P=0.013 ) ; however , they did not show significant improvement in self-efficacy pertaining to emotional eating ( P=0.155 ) and exercise ( P=0.680 ) . Conclusion : The results suggest that inclusion of children and parents in the same intervention program is an effective way to decrease adiposity and improve nutrition behaviors in both children and parents and improve weight and eating self-efficacy in parents OBJECTIVE To test the hypothesis that family dietary coaching would improve nutritional intakes and weight control in free-living ( noninstitutionalized ) children and parents . DESIGN R and omized controlled trial . SETTING Fifty-four elementary schools in Paris , France . PARTICIPANTS One thous and thirteen children ( mean age , 7.7 years ) and 1013 parents ( mean age , 40.5 years ) . INTERVENTION Families were r and omly assigned to group A ( advised to reduce fat and to increase complex carbohydrate intake ) , group B ( advised to reduce both fat and sugar and to increase complex carbohydrate intake ) , or a control group ( given no advice ) . Groups A and B received monthly phone counseling and Internet-based monitoring for 8 months . OUTCOME MEASURES Changes in nutritional intake , body mass index ( calculated as weight in kilograms divided by height in meters squared ) , fat mass , physical activity , blood indicators , and quality of life . RESULTS Compared with controls , participants in the intervention groups achieved their nutritional targets for fat intake and to a smaller extent for sugar and complex carbohydrate intake , leading to a decrease in energy intake ( children , P < .001 ; parents , P = .02 ) . Mean changes in body mass index were similar among children ( group A , + 0.05 , 95 % confidence interval [ CI ] , - 0.06 to 0.16 ; group B , + 0.10 , 95 % CI , - 0.03 to 0.23 ; control group , + 0.13 , 95 % CI , 0.04 - 0.22 ; P = .45 ) , but differed in parents ( group A , + 0.13 , 95 % CI , - 0.01 to 0.27 ; group B , - 0.02 , 95 % CI , - 0.14 to 0.11 ; control group , + 0.24 , 95 % CI , 0.13 - 0.34 ; P = .001 ) , with a significant difference between group B and the control group ( P = .01 ) . CONCLUSIONS Family dietary coaching improves nutritional intake in free-living children and parents , with beneficial effects on weight control in parents . Trial Registration clinical trials.gov Identifier : NCT00456911 High-intensity interval training ( HIIT ) consists of short intervals of exercise at high intensity intermitted by intervals of lower intensity and is associated with improvement of body composition and metabolic health in adults . Studies in overweight adolescents are scarce . We conducted a r and omized controlled trial in overweight adolescents to compare acceptance and attendance of HIIT with or without weekly motivational encouragement through text messages and access to a study website . HIIT was offered for six months ( including summer vacation ) twice a week ( 60 min/session ) . Participation rates were continuously assessed and acceptance was measured . Clinical parameters were assessed at baseline and after six months . Twenty-eight adolescents participated in this study ( age 15.5 ± 1.4 ; 54 % female ) . The st and ard deviation score for body mass index over all participants was 2.33 at baseline and decreased by 0.026 ( 95 % CI −0.048 to 0.10 ) units , p = 0.49 . Waist to height ratio was 0.596 at baseline and decreased by 0.013 ( 95 % CI 0.0025 to 0.024 ) , p = 0.023 . Participation within the first two months ranged from 65 % to 75 % , but fell to 15 % within the last three months . Attendance in the intervention group was 14 % ( 95 % CI −8 to 37 ) , p = 0.18 , higher than the control group . Overall program content was rated as “ good ” by participants , although high drop-out rates were observed . Summer months constitute a serious problem regarding attendance . The use of media support has to be assessed further in appropriately powered trials BACKGROUND AND OBJECTIVE : Clinic-based programs for childhood obesity are not available to a large proportion of the population . The purpose of this study was to evaluate the efficacy of a guided self-help treatment of pediatric obesity ( GSH-PO ) compared with a delayed treatment control and to evaluate the impact of GSH-PO 6-months posttreatment . METHODS : Fifty overweight or obese 8- to 12-year-old children and their parents were r and omly assigned to immediate treatment or to delayed treatment . The GSH-PO includes 12 visits over 5 months and addresses key components included in more intensive clinic-based programs . Children and parents in the immediate treatment arm were assessed at time 1 ( T1 ) , participated in GSH-PO between T1 and T2 , and completed their 6-month posttreatment assessment at T3 . Children and parents in the delayed treatment arm were assessed at T1 , participated in GSH-PO between T2 and T3 , and completed their 6-month posttreatment assessment at T4 . The main outcome measures were BMI , BMI z score , and percentage overweight ( % OW ) . RESULTS : Children in the immediate treatment GSH-PO arm decreased their BMI significantly more than did the delayed treatment arm ( BMI group × time = −1.39 ; P < .001 ) . Similar results were found for BMI z score and % OW . At the 6-month posttreatment assessment , changes result ing from GSH-PO were maintained for BMI z score and % OW but not BMI ( BMI time effect = −0.06 , not significant ; BMI z score time effect = −0.10 , P < .001 ; % OW time effect = −4.86 , P < .05 ) . CONCLUSIONS : The GSH-PO showed initial efficacy in decreasing BMI for children in this study . Additional efficacy and translational studies are needed to additionally evaluate GSH-PO PURPOSE The purpose of the study was to evaluate a parent involvement intervention for childhood obesity intended to increase parents ' skills in managing children 's weight-related behavior and to improve child-parent relationships . Many studies reported on parental influence on childhood obesity , emphasizing parent involvement in prevention and management of childhood obesity . METHODS A r and omized controlled trial was conducted . Forty-two parents of overweight/obese children were recruited from four cities and r and omized to the experimental group or control group . The parental intervention was provided only to parents in the experimental group and consisted of weekly newsletters and text messages for a period of 5 weeks . Exercise classes and nutrition education were provided to all children . Lifestyle Behaviour Checklist and the Child-Parent Relationship Scale ( CPRS ) were used for measurement of parent outcome . For the child outcome , dietary self-efficacy , exercise frequency , and body mass index were measured . A mixed- design analysis of variance was performed with city location entered as a r and om effect . RESULTS After the intervention , CPRS of parents and dietary self-efficacy of children showed an increase in the experimental group ( p < .05 ) . Intervention effects differed significantly according to the city location regarding the control efficacy of parents and dietary self-efficacy of children ( p < .05 ) . CONCLUSIONS The results support the effectiveness of the parent involvement intervention in promoting child-parent relationship and dietary self-efficacy of children . However , a 5-week parent involvement intervention was not sufficient to produce significant changes in children 's body mass index . Further research is needed to investigate effects of parent involvement intervention with long-term evaluation OBJECTIVE : To test the efficacy of an innovative family-based intervention for overweight preschool-aged children and overweight parents conducted in the primary care setting . METHODS : Children with BMI ≥85th percentile and an overweight parent were r and omized to intervention or information control ( IC ) . Trained staff delivered dietary and physical/sedentary activities education to parents over 6 months ( 10 group meetings and 8 calls ) . Parents in the intervention received also behavioral modification . An intention-to-treat analysis was performed by using mixed analysis of variance models to test changes in child percent over BMI ( % O BMI ) and z- BMI and to explore potential moderators of group differences in treatment response . RESULTS : Ninety-six of 105 r and omized families started the program : 46 children ( 31 girls/15 boys ) in the intervention and 50 ( 33 girls/17 boys ) in the IC , with 33 and 39 mothers and 13 and 11 fathers in intervention and IC , respectively . Baseline characteristics did not differ between groups . Children in the intervention group had greater % O BMI and z- BMI decreases at 3 and 6 months compared with those assigned to IC ( P < .0021 ) . A greater BMI reduction over time was also observed in parents in the intervention compared with parents assigned to IC ( P < .0001 ) . Child % O BMI and parent BMI changes were correlated ( r = .31 ; P = .003 ) . Children with greater baseline % O BMI were more likely to have a greater % O BMI decrease over time ( P = .02 ) . CONCLUSIONS : Concurrently targeting preschool-aged overweight youth and their overweight parents for behavioral weight control in a primary care setting reduced child % O BMI and parent BMI , with parent and child weight changes correlating OBJECTIVE A r and omized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for African-American girls over a 2-year period of intervention . RESEARCH METHODS AND PROCEDURES Fifty-seven overweight ( mean BMI percentile , 98.3 ) African-American girls ( mean age , 13.2 years ) were r and omly assigned to an interactive behavioral internet program or an internet health education program , the control condition . Overweight parents were also participants in the study . Forty adolescent-parent dyads ( 70 % ) completed the 2-year trial . Outcome data including BMI , body weight , body composition , and weight loss behaviors were collected at baseline and at 6-month intervals . A computer server tracked use of the web sites . RESULTS An intention-to-treat statistical approach was used , with the last observation carried forward . In comparison with the control condition , adolescents in the behavioral program lost more mean body fat ( BF ) ( -1.12 + /- 0.47 % vs. 0.43 + /- 0.47 % BF , p < 0.05 ) , and parents in the behavioral program lost significantly more mean body weight ( -2.43 + /- 0.66 vs. -0.35 + /- 0.64 kg , p < 0.05 ) during the first 6 months . This weight loss was regained over the next 18 months . After 2 years , differences in fat for adolescents ( -0.08 + /- 0.71 % vs. 0.84 + /- 0.72 % BF ) and weight for parents ( -1.1 + /- 0.91 vs. -0.60 + /- 0.89 kg ) did not differ between the behavioral and control programs . DISCUSSION An internet-based weight management program for African-American adolescent girls and their parents result ed in weight loss during the first 6 months but did not yield long-term loss due to reduced use of the web site over time OBJECTIVE To evaluate the effect of a 3-year after-school physical activity ( PA ) intervention on aerobic fitness and percent body fat ( % BF ) . METHODS In total , 18 schools were r and omized into intervention or control arms . Measurements were made at the beginning and end of the third , fourth and fifth grade s. Fitness was measured with heart rate response to a bench-stepping task.%BF and bone density were measured with dual-energy x-ray absorptiometry . The intervention included 40 min of academic enrichment activities , during which healthy snacks were provided , and 80 min of moderate-to-vigorous PA ( MVPA ) . RESULTS Data analyses were performed on 206 youths who remained in the same schools for the 3-year period , who were measured at all six time points and , for the intervention group , who attended at least 40 % of the sessions in each of the 3 years . The group by time interactions were significant for fitness ( p < 0.01 ) and % BF ( p < 0.05 ) . Children in intervention schools improved in fitness and % BF during the school years and returned to levels similar to those in control schools during the summers . Over the six measurement points , the intervention group increased more than the control group in bone density ( p < 0.01 ) , fat-free soft tissue ( p < 0.01 ) , weight ( p < 0.01 ) , height ( p < 0.01 ) , and body mass index ( p < 0.05 ) . CONCLUSIONS An after-school program focusing on MVPA had a beneficial effect on fitness and body composition . During the summers , the beneficial effect of the previous year 's participation on fitness and % BF was lost . This highlights the importance of year-round programs to promote healthy growth in youths Lifestyle modification programs ( LMP ) for weight loss in adolescents with obesity are effective but not available . Primary care may be a setting for reaching more adolescents . Two models of LMP for use in primary care were examined . Adolescents and caregivers enrolled in a 1-year r and omized trial comparing Group LMP with Self-Guided LMP . All participants ( N = 169 ) received the same treatment recommendations and met with a health coach six times in clinic . Group LMP participants had an additional 17 group sessions ; those in Self-Guided LMP followed the remainder of the program at home with parental support . The primary outcome was percentage change in initial body mass index . The mean ( SE ) 1.31 % ( 0.95 % ) reduction in Group LMP did not differ significantly from the 1.17 % ( 0.99 % ) decrease in the Self-Guided LMP ( p = 0.92 ) . Both treatments were significantly effective in reducing body mass index . Given its brevity , the Self-Guided LMP offers an innovative approach for primary care Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan . The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention , the MEND ( Mind Exercise Nutrition Do It ! ) program that is delivered to parents of children aged 2 - 4 years . Methods / Design This r and omised controlled trial will be conducted with 200 parents and their 2 - 4 year old children who attend the MEND 2 - 4 program in metropolitan and regional Victoria . Parent-child dyads will attend ten 90-minute group workshops . These workshops focus on general nutrition , as well as physical activity and behaviours . They are typically held at community or maternal and child health centres and run by a MEND 2 - 4 trained program leader . Child eating habits , physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline , the end of the intervention , and at 6 and 12 months post the intervention . Informed consent will be obtained from all parents , who will then be r and omly allocated to the intervention or wait-list control group . Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2 - 4 years . It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents , given that parental beliefs , attitudes , perceptions and behaviours appear to impact significantly on the development of early overweight . This is ' solution-oriented ' rather than ' problem-oriented ' research , with its focus being on prevention rather than intervention . If this is a positive trial , the MEND2 - 4 program can be implemented as a national program . Trial Registration Australian New Zeal and Clinical Trials Registry BACKGROUND Few successful treatment modalities exist to address childhood obesity . Given Latinos ' strong identity with family , a family-focused intervention may be able to control Latino childhood obesity . PURPOSE To assess the feasibility and effectiveness of a family-centered , primary care-based approach to control childhood obesity through lifestyle choices . DESIGN R and omized waitlist controlled trial in which control participants received the intervention 6 months after the intervention group . SETTING / PARTICIPANTS Forty-one Latino children with BMI > 85 % , aged 9 - 12 years , and their caregivers were recruited from an urban community health center located in a predominantly low-income community . INTERVENTION Children and their caregivers received 6 weeks of interactive group classes followed by 6 months of culturally sensitive monthly in-person or phone coaching to empower families to incorporate learned lifestyles and to address both family and social barriers to making changes . MAIN OUTCOMES MEASURES Caregiver report on child and child self-reported health-related quality of life ( HRQoL ) ; metabolic markers of obesity ; BMI ; and accelerometer-based physical activity were measured July 2010-November 2011 and compared with post-intervention assessment s conducted at 6 months and as a function of condition assignment . Data were analyzed in 2012 . RESULTS Average attendance rate to each group class was 79 % . Socio-environmental and family factors , along with knowledge , were cited as barriers to changing lifestyles to control obesity . Caregiver proxy and child self-reported HRQoL improved for both groups with a larger but not nonsignificant difference among intervention vs control group children ( p=0.33 ) . No differences were found between intervention and control children for metabolic markers of obesity , BMI , or physical activity . CONCLUSIONS Latino families are willing to participate in group classes and health coaching to control childhood obesity . It may be necessary for primary care to partner with community initiatives to address childhood obesity in a more intense manner . TRIAL REGISTRATION This study is registered at Clinical trials.partners.org 2009P001721 Background : The best outcomes for treating childhood obesity have come from comprehensive family-based programmes . However there are questions over their generalizability . Objective : To examine the acceptability and effectiveness of ‘ family-based behavioural treatment ’ ( FBBT ) for childhood obesity in an ethnically and socially diverse sample of families in a UK National Health Service ( NHS ) setting . Methods : In this parallel group , r and omized controlled trial , 72 obese children were r and omized to FBBT or a waiting-list control . Primary outcomes were body mass index ( BMI ) and BMI s.d . scores ( SDSs ) . Secondary outcomes were weight , weight SDSs , height , height SDSs , waist , waist SDSs , FM index , FFM index , blood pressure ( BP ) and psychosocial measures . The outcomes were assessed at baseline and after treatment , with analyses of 6-month data performed on an intent-to-treat ( ITT ) basis . Follow-up anthropometric data were collected at 12 months for the treatment group . Results : ITT analyses included all children with baseline data ( n=60 ) . There were significant BMI SDS changes ( P<0.01 ) for the treatment and control groups of −0.11 ( 0.16 ) and −0.10 ( 1.6 ) . The treatment group showed a significant reduction in systolic BP ( −0.24 ( 0.7 ) , P<0.05 ) and improvements in quality of life and eating attitudes ( P<0.05 ) , with no significant changes for the control group . However the between-group treatment effects for BMI , body composition , BP and psychosocial outcomes were not significant . There was no overall change in BMI or BMI SDSs from 0–12 months for the treatment group . No adverse effects were reported . Conclusions : Both treatment and control groups experienced significant reductions in the level of overweight , but with no significant difference between them . There were no significant group differences for any of the secondary outcomes . This trial was registered at http://www.controlled-trials.com/ under IS RCT N 51382628 The one-year outcome of the r and omized controlled T.A.F.F. ( Telephone based Adiposity prevention For Families ) study is presented . Screening of overweight ( BMI -SDS > 90th centile ) children 3.5–17.4 years was performed via the German CrescNet data base , and c and i date s were r and omized to an intervention group ( IG ) and control group ( CG ) . The intervention consisted of computer-aided telephone counselling for one year , supported by mailed newsletters . The primary endpoint was change in BMI -SDS ; secondary endpoints were eating behavior , physical activity , media consumption , quality of life . Data from 289 families ( 145 IG ( 51 % females ) ; 144 CG ( 50 % females ) ) were analyzed ( Full Analysis Set : FAS ; Per Protocol Set : PPS ) . Successful intervention was defined as decrease in BMI -SDS ≥ 0.2 . In the FAS , 21 % of the IG was successful as compared to 16 % from the CG ( 95 % CI for this difference : ( −4 , 14 ) , p = 0.3 , mean change in BMI -SDS : −0.02 for IG vs. 0.02 for CG ; p = 0.4 ) . According to the PPS , however , the success rate was 35 % in the IG compared to 19 % in the CG ( mean change in BMI -SDS : −0.09 for IG vs. 0.02 for CG ; p = 0.03 ) . Scores for eating patterns ( p = 0.01 ) , media consumption ( p = 0.007 ) , physical activity ( p = 9 × 10−9 ) , quality of life ( p = 5 × 10−8 ) decreased with age , independent of group or change in BMI -SDS . We conclude that a telephone-based obesity prevention program suffers from well-known high attrition rates so that its effectiveness could only be shown in those who adhered to completion . The connection between lifestyle and weight status is not simple and requires further research to better underst and OBJECTIVE The goal of this study was to evaluate the effect of a parent-focused behavioral intervention on parent and child eating changes and on percentage of overweight changes in families that contain at least one obese parent and a non-obese child . RESEARCH METHODS AND PROCEDURES Families with obese parents and non-obese children were r and omized to groups in which parents were provided a comprehensive behavioral weight-control program and were encouraged to increase fruit and vegetable intake or decrease intake of high-fat/high-sugar foods . Child material s targeted the same dietary changes as their parents without caloric restriction . RESULTS Changes over 1 year showed that treatment influenced targeted parent and child fruit and vegetable intake and high-fat/high-sugar intake , with the Increase Fruit and Vegetable group also decreasing their consumption of high-fat/high-sugar foods . Parents in the increased fruit and vegetable group showed significantly greater decreases in percentage of overweight than parents in the decreased high-fat/high-sugar group . DISCUSSION These results suggest that focusing on increasing intake of healthy foods may be a useful approach for nutritional change in obese parents and their children Using self-determination theory ( SDT ) as an explanatory framework , this r and omised-controlled study evaluates the effect of a motivational interviewing (MI)-based intervention as an addition to a st and ard weight loss programme ( SWLP ) on physical activity ( PA ) practice in obese adolescents over a six-month period . Fifty-four obese adolescents ( mean age = 13 years , mean BMI = 29.57 kg/m² ) were r and omly assigned to an SWLP group ( n = 28 ) or SWLP + MI group ( n = 26 ) . Both groups received two SWLP sessions , supplemented for the SWLP + MI group , by six MI sessions . Perceived autonomy support , perceived competence , motivational regulations , PA and BMI were assessed at baseline , three and six months ( i.e. the end of the programme ) . MLM analyses revealed that compared to SWLP , the SWLP + MI group had a greater BMI decrease and a greater PA practice increase over time . Moreover , the SWLP + MI group reported greater autonomy support from medical staff at the end of the programme , greater increase in integrated and identified regulations and a stronger decrease in amotivation . MI appears as an efficient counselling method as an addition to an SWLP to promote PA in the context of pediatric obesity IMPORTANCE Active video games may offer an effective strategy to increase physical activity in overweight and obese children . However , the specific effects of active gaming when delivered within the context of a pediatric weight management program are unknown . OBJECTIVE To evaluate the effects of active video gaming on physical activity and weight loss in children participating in an evidence -based weight management program delivered in the community . DESIGN , SETTING , AND PARTICIPANTS Group-r and omized clinical trial conducted during a 16-week period in YMCAs and schools located in Massachusetts , Rhode Isl and , and Texas . Seventy-five overweight or obese children ( 41 girls [ 55 % ] , 34 whites [ 45 % ] , 20 Hispanics [ 27 % ] , and 17 blacks [ 23 % ] ) enrolled in a community-based pediatric weight management program . Mean ( SD ) age of the participants was 10.0 ( 1.7 ) years ; body mass index ( BMI ) z score , 2.15 ( 0.40 ) ; and percentage overweight from the median BMI for age and sex , 64.3 % ( 19.9 % ) . INTERVENTIONS All participants received a comprehensive family-based pediatric weight management program ( JOIN for ME ) . Participants in the program and active gaming group received hardware consisting of a game console and motion capture device and 1 active game at their second treatment session and a second game in week 9 of the program . Participants in the program-only group were given the hardware and 2 games at the completion of the 16-week program . MAIN OUTCOMES AND MEASURES Objective ly measured daily moderate-to-vigorous and vigorous physical activity , percentage overweight , and BMI z score . RESULTS Participants in the program and active gaming group exhibited significant increases in moderate-to-vigorous ( mean [ SD ] , 7.4 [ 2.7 ] min/d ) and vigorous ( 2.8 [ 0.9 ] min/d ) physical activity at week 16 ( P < .05 ) . In the program-only group , a decline or no change was observed in the moderate-to-vigorous ( mean [ SD ] net difference , 8.0 [ 3.8 ] min/d ; P = .04 ) and vigorous ( 3.1 [ 1.3 ] min/d ; P = .02 ) physical activity . Participants in both groups exhibited significant reductions in percentage overweight and BMI z scores at week 16 . However , the program and active gaming group exhibited significantly greater reductions in percentage overweight ( mean [ SD ] , -10.9%[1.6 % ] vs -5.5%[1.5 % ] ; P = .02 ) and BMI z score ( -0.25 [ 0.03 ] vs -0.11 [ 0.03 ] ; P < .001 ) . CONCLUSIONS AND RELEVANCE Incorporating active video gaming into an evidence -based pediatric weight management program has positive effects on physical activity and relative weight . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01757925 Background Girl Scouting may offer a viable channel for health promotion and obesity prevention programs . This study evaluated the effectiveness of an intervention program delivered through Girl Scout Junior troops that was design ed to foster healthful troop meeting environments and increase obesity prevention behaviors at home . Methods Seven Girl Scout troops were r and omized to intervention ( n = 3 , with 34 girls ) or st and ard-care control ( n = 4 , with 42 girls ) conditions . Girls ranged in age from 9 to 13 years ( mean 10.5 years ) . Intervention troop leaders were trained to implement policies promoting physical activity ( PA ) and healthful eating opportunities at troop meetings , and to implement a curriculum promoting obesity-prevention behaviors at home . The primary outcome variable was child body mass index ( BMI ) z-score . Secondary outcomes included accelerometer-assessed PA levels in troop meetings , direct observations of snack offerings , time spent in physically active meeting content , and leader encouragement of PA and healthful eating . Results The intervention was delivered with good fidelity , and intervention troops provided greater opportunities for healthful eating and PA ( x2 = 210.8 , p < .001 ) , relative to control troops . In troop meetings , intervention troop leaders promoted PA ( x2 = 23.46 , p < .001 ) and healthful eating ( x2 = 18.14 , p < .001 ) more frequently , and discouraged healthful eating and PA less frequently ( x2 = 9.63 , p = .002 ) compared to control troop leaders . Most effects of the intervention on individual-level variables of girls and parents were not significantly different from the control condition , including the primary outcome of child BMI z-score ( F1 , 5 = 0.42 , p = .544 ) , parent BMI ( F1 , 5 = 1.58 , p = .264 ) , and related behavioral variables . The notable exception was for objective ly assessed troop PA , wherein girls in intervention troops accumulated significantly less sedentary ( x2 = 6.3 , p = .011 ) , significantly more moderate ( x2 = 8.2 , p = .004 ) , and more moderate-to-vigorous physical activity , ( x2 = 18.4 , p < .001 ) , than girls in control troops . Conclusions Implementing a health promotion curriculum and supporting policies to provide more healthful environments in Girl Scout troop meetings appears feasible on a broader scale . Additional work is needed to bridge health promotion from such setting s to other environments if lasting individual-level behavior change and obesity prevention remain targeted outcomes . Trial registration number : INTRODUCTION Internet based obesity prevention program is one approach in learning strategies to improve healthy behaviour . It has been advocated as one strategy to address the rising prevalence of childhood obesity ; however , their efficacy is not seen consistently . AIM The purpose of this study was to assess the efficacy of internet based obesity prevention program in Thai school children . MATERIAL S AND METHODS Healthy children study ing in public schools in one township of central Thail and were r and omly assigned to either the intervention ( internet based ) program or the control group . Anthropometric characteristics were recorded at baseline and for the next four following months at monthly intervals . Changes in the percentage of overweight/obese children and changes in BMI at the end of study were considered as the primary and secondary outcome , respectively . RESULTS A total of 217 children , mean age of 10.7 years , were included into the final analysis . Baseline anthropometric parameters and percentages of overweight/obesity were not significantly different between groups . At the end of the study , the control group had a higher percentage of overweight/obesity than the intervention group ( 56.6 % vs. 39.6 % , respectively ; p-value=0.009 ) . Children in the control group had a significantly higher increase in net BMI gains than those in the intervention group ( 1.24kg/m2 vs. 0.40kg/m2 , p-value=0.027 ) . The intervention group had no changes in BMI z-score ( -0.001 , 95%CI -0.19 to 0.18 , p-value=0.988 ) , contrary to those in the control group , which had significant gain of BMI z-score at the end of study ( 0.45 , 95%CI 0.27 to 0.63 , p-value<0.001 ) . CONCLUSION Internet the based obesity prevention program was effective in modifying anthropometric outcome and helped to address the rising prevalence of overweight and obese status in Thai children BACKGROUND Dairy foods are nutrient rich but also a source of saturated fat in the diets of children . OBJECTIVE We assessed effects on dietary intakes and health outcomes of changing dairy foods consumed by children from regular- to reduced-fat varieties . DESIGN This study was a 24-wk cluster r and omized controlled trial in 93 families with 4 - 13-y-olds who were r and omly allocated to parental education regarding changing to reduced-fat dairy foods ( n = 76 children ) or reducing screen time ( n = 69 children ) . Study outcomes , which were measured at weeks 0 , 12 ( end of the intervention ) , and 24 , included saturated fat , energy , and nutrient intakes ; pentadecanoic acid and blood lipid concentrations ; body mass index z score ; and waist circumference . Multilevel analyses were used with adjustment for child- and family-level covariates . RESULTS There were no group differences in overall dairy intakes ( -45 g dairy ; 95 % CI : -141 , 51 g dairy ; P = 0.356 ) . Saturated fat intakes were 3.3 percentage points lower ( P < 0.0001 ) in the intervention group at week 24 than in the comparison group . Pentadecanoic acid concentrations were lower at week 12 ( 0.03 % ; P = 0.012 ) but not at week 24 . LDL-cholesterol concentrations were not different at week 12 , but LDL-cholesterol concentration was 0.15 mmol/L lower in the intervention group at week 24 than in the comparison group ( P = 0.037 ) . There were no significant group differences in total energy or adiposity measures . Regular-fat dairy foods decreased from 88 % to 14 % of dairy intake in the intervention group . Calcium , magnesium , and carbohydrate ( percentage of energy ) intakes were higher in the intervention group than in the comparison group ; retinol intakes were lower in the intervention group than in the comparison group ; and overall vitamin A intakes were similar between groups . CONCLUSION Advice to parents to change to reduced-fat products was effective in reducing children 's saturated fat intakes but did not alter energy intakes or measures of adiposity . This trial was registered in the Australia New Zeal and Clinical Trials Registry as ACTRN12609000453280 Background Effective lifestyle interventions are needed to prevent noncommunicable diseases in low- and middle-income countries . We analyzed the effects of a school-based health promotion intervention on physical fitness after 28 months and explored if the effect varied with important school characteristics . We also assessed effects on screen time , physical activity and BMI . Methods and results We performed a cluster-r and omized pair matched trial in schools in urban Ecuador . The intervention included an individual and environmental component tailored to the local context and re sources . Primary outcomes were physical fitness ( EUROFIT battery ) , screen time ( question naires ) and physical activity ( accelerometers ) . Change in BMI was a secondary outcome . A total of 1440 grade 8 and 9 adolescents ( intervention : n = 700 , 48.6 % ) and 20 schools ( intervention : n = 10 , 50 % ) participated . Data of 1083 adolescents ( intervention : n = 550 , 50.8 % ) from 20 schools were analyzed . The intervention increased vertical jump ( mean effect 2.5 cm ; 95 % CI 0.8 - 4.2 ; P = 0.01 ) . Marginally insignificant , adolescents from the intervention group needed less time for speed shuttle run ( intervention effect = −0.8 s , 95 % CI −1.58 - 0.07 ; P = 0.05 ) . The proportion of students achieving over 60 minutes of moderate-to-vigorous physical activity/day decreased over time with the change in proportion significantly less in the intervention schools ( 6 vs. 18 percentage points , P < 0.01 ) . The intervention effect on speed shuttle run was significant in larger schools while the effect on vertical jump was larger in mixed gender school compared to small and female schools . The proportion of schools that met the recommendations for physical activity increased with 37 % in intervention schools with half-day schedule compared to the controls in the pair . No significant effects were found on screen time and BMI . Measurement of physical activity in a sub sample was a limitation . No adverse effects were reported . Conclusions A school-based intervention with an individual and environment component can improve physical fitness and can minimize the decline in physical activity levels from childhood into adolescence in urban Ecuador . Trial registration Clinical trials.gov identifier NCT01004367 BACKGROUND The Care Of Childhood Obesity ( COCO ) clinic at the Bristol Royal Hospital for Children ( BRHC ) uses a multidisciplinary approach comprising a consultant , dietitian , and exercise specialist . The clinic has demonstrated efficacy in managing children 's weight but similar clinics are scarce in the UK . AIM This pilot r and omised controlled trial ( RCT ) aim ed to examine the feasibility of undertaking a fully powered RCT and to gauge whether the COCO model could be effective as a nurse-led clinic in primary care setting s. DESIGN AND SETTING Patients were r and omised to a hospital-based childhood obesity clinic or a nurse-led clinic in a primary care setting in south-west Engl and . METHOD Children aged 5 - 16 years with a body mass index ( BMI ) ≥98th centile were referred by GPs to the consultant in charge of the COCO clinic at BRHC . Referred children were clinical ly screened for suitability and invited into the study . Consenting families were r and omised to BRHC or a primary care clinic ( PCC ) and offered five appointments over 12 months . Clinical effectiveness was measured by change in body mass index st and ard deviation score ( BMI SDS ) at 12 months . Other measures included : treatment adherence , quality of life ( QOL ) , and satisfaction . Feasibility was examined by assessing referral , screening , and recruitment data . RESULTS A total 152 patients were referred by GPs : 31 ( 20 % ) were screened out ; 45 ( 30 % ) declined to participate . Seventy-six ( 50 % ) patients were r and omised and 68 provided baseline data ( PCC = 42 ; BRHC = 26 ) ; 52 provided outcome data ( PCC = 29 ; BRHC = 23 ) . Mean change in BMI SDS was PCC -0.17 ( 95 % confidence interval [ CI ] = -0.27 to -0.07 ) ; BRHC -0.15 ( 95 % CI = -0.26 to -0.05 ) . QOL , adherence , and satisfaction data indicated similar positive patterns in both trial arms . CONCLUSION Screening and recruitment data indicate that primary care is a clinical ly appropriate setting and acceptable to families . The primary clinical outcome measure ( reduction in BMI SDS ) , along with secondary outcome measures , indicate that primary care has the potential to be effective in providing weight management for children , using the COCO model Background Obesity amongst children is a growing problem worldwide . In contrast to adults , little is known on the effects of controlled weight loss on components of the metabolic syndrome in children . The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance intervention on body mass index ( BMI ) in a group of overweight children . Our hypothesis was an observed reduction in BMI and secondarily in body fat content , insulin insensitivity , and other components of the metabolic syndrome in the intervention group . Methods School children from Copenhagen were r and omly allocated to an intervention group ( n = 19 ) or a control group ( n = 19 ) . Anthropometric assessment , whole body dual-energy X-ray absorptiometry scan , two hours oral glucose tolerance test , steps measured by pedometer , and fitness tests were measured at baseline and at 20 weeks . Results Thirty-seven children ( 30 girls ) participated at baseline , aged 8.7 ± 0.9 years with a BMI of 21.8 ± 3.7 kg/m2 ( mean ± SD ) , and 36 children completed the study . The intervention group decreased their BMI ( the intervention effect is the difference in change between the groups adjusted for the respective baseline values ( DELTA ) = -2.0 kg/m2 , 95 % CI : -2.5 ; -1.5 , P < 0.001 ) , total body mass ( DELTA = -4.0 kg , 95 % CI : -4.9 ; -3.0 , P < 0.001 ) , and fat mass ( DELTA = -3.3 kg , 95 % CI : -4.2 ; -2.7 , P < 0.001 ) compared to the control group after the intervention . The intervention group displayed decreased waist , hip and waist-to-height ratio ( WHtR ) ( all three variables ; P < 0.001 ) , area under curve for plasma insulin ( P < 0.05 ) , and increased mean and minimum steps/day ( P < 0.05 and P < 0.01 , respectively ) . Conclusions The multicomponent intervention had significant favorable effects on BMI , weight , WHtR , mean and minimum steps/day , and fat mass . In addition , similar beneficial metabolic effects were found in the children as shown in adults , e.g. increase in peripheral insulin sensitivity . Trial registration Clinical trials.gov Identifier number NCT01660789 Objective . To evaluate the effect of two intervention modalities concerning overweight and obesity among children in general practice . Design . Prospect i ve r and omized controlled trial . Setting . A total of 60 general practice s in the former County of Funen , Denmark . Subjects . Overweight children , identified by International Obesity Task Force criteria , aged 5–9 years . Intervention . Model 1 with health consultations in general practice during a two-year period or Model 2 , an educational programme for the children and their families in addition to the health consultations . Main outcome measures . Change in body mass index ( BMI ) z-score in order to compare the results , independent of gender- and age-related changes over time . Results . A total of 80 children were recruited with 35 and 45 children allocated to Model 1 and Model 2 , respectively . No significant differences were found in the change in BMI z-score ( SDS ) between the two groups . A decrease in the mean BMI z-score from baseline to study end of −0.20 ( 95%CI −0.38 to −0.01 ) in Model 1 and −0.26 ( 95%CI −0.44 to −0.09 ) in Model 2 , respectively , was detected . The majority of the participants ( 2/3 ) continued in the study for more than one year in both models , with a mean of 12 consultations in general practice . Conclusion . In this particular setting the two intervention strategies against overweight and obesity did not differ significantly with regard to change in BMI z-scores BACKGROUND US Hispanic children experience a disproportionate burden of overweight and obesity . Comprehensive high-intensity behavioral programs have demonstrated effectiveness in improving weight status among obese children . However , there remains a need to develop more efficient interventions that are feasible in primary care and demonstrate effectiveness in Hispanic children . METHODS The pilot study used a two-group r and omized design . Eligible overweight ( BMI between the 85th and 94th percentile for age and gender ) or obese ( BMI ≥95th percentile ) Hispanic children and their parents ( N=118 child/parent dyads ) were recruited from a rural pediatric clinic and r and omized to : st and ard care ( SC ; n=61 dyads ) or behavioral intervention ( INT ; n=57 dyads ) . The primary outcomes -weight , waist circumference , and z BMI -were measured at baseline , 2 , 6 , and 18 weeks . Multivariate logistic regression was used to examine the effect of INT on the likelihood of weight maintenance adjusting for potential confounding variables . RESULTS Significantly fewer INT children ( 68.5 % ) experienced weight gain , compared to SC children ( 89.7 % ; p=0.009 ) . The same pattern was observed for waist circumference , where fewer INT children ( 44 % ) experienced an increase in waist circumference , compared to SC children ( 68.6 % ; p=0.02 ) . Although a trend of improvement in favor of the INT was observed for z BMI , it was not significant . CONCLUSIONS This study provides preliminary evidence for the feasibility of a primary -care-based approach to promoting weight maintenance among a high-risk population INTRODUCTION AND OBJECTIVES The MOVI physical activity program has been shown to reduce adiposity and to improve serum lipid profiles in schoolchildren . However , MOVI may have not achieved its maximum potential effectiveness , as increased physical activity on weekdays may have been offset by more sedentary behavior at weekends . We therefore developed the MOVI-2 program , which includes physical activity at weekends as well . This paper reports the rationale and methods of a trial to assess the effectiveness of MOVI-2 in preventing overweight and reducing cardiovascular risk in 1200 4th- and 5th- grade primary schoolchildren in Cuenca , Spain . METHODS Ten schools were r and omly assigned to MOVI-2 and 10 schools to the control group . MOVI-2 consisted of recreational physical activity in after-school time , including two 90-min sessions on weekdays and one 150-min session on Saturdays , during each week of one academic year . The control group was expected to follow their usual patterns of physical activity . The primary end points , which were assessed at the start and the end of the MOVI-2 program , were weight and height , waist circumference , skinfold thickness , body fat percentage , blood pressure , lipid profile , and insulin resistance . Secondary end points were physical activity , fitness , health-related quality of life , sleep quality , academic performance , enjoyment with physical activity , and physical self-concept . CONCLUSIONS This study will assess whether MOVI-2 overcomes some potential limitations of physical activity interventions in children ( Clinical trials.gov number NCT01277224 ) OBJECTIVE The purpose of this pilot novel chiropractic health education intervention was to gather preliminary evidence regarding possible benefits from recreational youth soccer and nutrition education in overweight women . A secondary purpose was to determine whether some nutrition knowledge is an independent predictor of changes in body mass index ( BMI ) . METHODS A quiz developed and vali date d on separate age and sex appropriate blinded cohorts was used on study participants -22 volunteers of 57 eligible fourth- grade , overweight female Mississippi public school students . At the beginning of a 5-month study period , a 15-minute baseline nutrition intervention , grounded in Social Cognitive Theory and based on the United States Department of Agriculture 's " My Tips for Families " information , was applied in a chiropractic clinic . Subjects were then r and omized to 2 months of recreational soccer ( n = 14 ) or waiting list control ( n = 8) . RESULTS No preintervention differences were found in height , weight , BMI , or age . Higher follow-up BMI scores were found in both groups , and no significant differences between groups were found , possibly because of the small sample sizes and the short 8-week soccer intervention period . Gains in nutrition knowledge were sustained ( P < .002 ) ; however , there was no association between nutrition knowledge and follow-up BMI ( r = -.185 ; P < .462 ) . CONCLUSIONS Minimal nutrition education alone may be an ineffective intervention for overweight children . The study provides an example of how youth soccer may benefit overweight children OBJECTIVE To assess the feasibility , acceptability , and outcomes of 2 versions of a culturally relevant , family-based intervention to prevent excess weight gain in pre-adolescent African-American girls . DESIGN Three-arm , 12-week parallel group r and omized controlled pilot trial . SETTING Community centers in Memphis , Tennessee . PARTICIPANTS Sixty African-American girls , aged 8 to 10 years , with a body mass index ( BMI ) > or = 25th percentile of the CDC growth charts , along with their parents/caregivers . INTERVENTIONS The active interventions involved highly interactive weekly group sessions with either girls ( child-targeted program ) or parents/caregivers ( parent-targeted program ) . Content focused on knowledge and behavior change skills to promote healthy eating and increased physical activity . The comparison intervention focused on global self-esteem . MAIN OUTCOME MEASURES Given the lack of power and the limited time frame of the pilot study , outcomes were evaluated on the basis of implementation measures and changes in physical activity ( accelerometer data ) , and in consumption of sweetened beverages and water , as estimated from question naires . Changes in body mass index , waist circumference , and body composition were also examined . RESULTS The Memphis GEMS pilot intervention met all recruitment , retention , implementation , and participation goals , and was given high rating by both participants and interventionists . With respect to the comparison intervention , girls in both the child-targeted and parent-targeted interventions demonstrated a trend toward reduced body mass index and waist circumference . In addition , girls in the active intervention groups reduced their consumption of sweetened beverages by 34 % , increased their level of moderate-to-vigorous activity by 12 % , and increased their serving ; of water by 1.5 % . CONCLUSIONS The findings from this pilot study demonstrated the feasibility , perceived acceptability , and efficacy of culturally relevant , obesity prevention interventions for pre-adolescent African-American girls and their parents/caregivers Background In the Netherl and s , the first adolescents with diabetes mellitus type 2 as a result of obesity have recently been diagnosed . Therefore , it is very important that programs aim ing at the prevention of type 2 diabetes of obese adolescents are developed and evaluated . Methods Go4it is a multidisciplinary group treatment that focuses on : 1 ) increasing awareness of the current dietary and physical activity behaviour ( i.e. energy balance behaviour ) , 2 ) improving diet , 3 ) decreasing sedentary behaviour , 4 ) increasing levels of physical activity , and 5 ) coping with difficult situations . Go4it consists of 7 sessions with an interval of 2–3 weeks . The effectiveness of the multidisciplinary group treatment compared with usual care ( i.e. referral to a dietician ) was evaluated in a r and omised controlled trial . We examined effects on BMI ( sds ) , body composition , energy expenditure , glucose tolerance and insulin resistance ( primary outcome measure ) , as well as dietary and physical activity behaviour and quality of life . An economic evaluation from a societal perspective was conducted alongside the r and omised trial to evaluate the cost-effectiveness of the multidisciplinary treatment program vs. usual care . Discussion In this paper we described a multidisciplinary treatment program ( Go4it ) for obese adolescents and the design of a r and omised controlled trial and economic evaluation to evaluate its effectiveness and cost-effectiveness . Trial registration Netherl and s Trial Register ( IS RCT N27626398 ) OBJECTIVE To examine associations between television viewing , sugar-sweetened beverage consumption , eating out , physical activity , and body weight change over 1 year . DESIGN Secondary data analysis from r and omized intervention trial . SETTING Households in the community . PARTICIPANTS Adults ( n = 153 ) and adolescents ( n = 72 ) from the same households . INTERVENTION Households were r and omized to a home-based obesity prevention intervention or to a no-intervention control group for a 1-year period . MAIN OUTCOME MEASURES Self-reported television viewing ( TV ) hours , diet , and physical activity . Body mass index ( BMI ) computed from measured weight and height ( primary outcome measure ) . ANALYSIS Mixed-model regression . RESULTS Among adolescents , a significant prospect i ve association was observed between decreases in television viewing hours and lower BMI z score at 1-year follow-up ( decreased TV hours : BMI z score mean = 0.65 ; no change or increase TV hours : BMI z score = 0.92 ; P < .02 ) . No significant prospect i ve associations were observed among adults . CONCLUSIONS AND IMPLICATION S Reducing television viewing may be an effective strategy to prevent excess weight gain among adolescents Abstract Background The Loozit ® Study is a r and omised controlled trial investigating extended support in a 24 month community-based weight management program for overweight to moderately obese , but otherwise healthy , 13 to 16 year olds . Methods This pre-post study examines the two month outcomes of the initial Loozit ® group intervention received by both study arms . Adolescents ( n = 151 ; 48 % male ) and their parents separately attended seven weekly group sessions focused on lifestyle modification . At baseline and two months , adolescents ' anthropometry , blood pressure , and fasted blood sample were assessed . Primary outcomes were two month changes in body mass index ( BMI ) z-score and waist-to-height-ratio ( WHtR ) . Secondary outcomes included changes in metabolic profile , self-reported dietary intake/patterns , physical and sedentary activities , psychological characteristics and social status . Changes in outcome measures were assessed using paired sample s t-tests for continuous variables or McNemar 's test for dichotomous categorical variables . Results Of the 151 adolescents who enrolled , 130 ( 86 % ) completed the two month program . Among these 130 adolescents ( 47 % male ) , there was a statistically significant ( P < 0.01 ) reduction in mean [ 95 % CI ] BMI ( 0.27 kg/m2 [ 0.41 , 0.13 ] ) , BMI z-score ( 0.05 [ 0.06 , 0.03 ] ) , WHtR ( 0.02 [ 0.03 , 0.01 ] ) , total cholesterol ( 0.14 mmol/L [ 0.24 , 0.05 ] ) and low-density lipoprotein cholesterol ( 0.12 mmol/L [ 0.21 , 0.04 ] ) . There were improvements in all psychological measures , the majority of the dietary intake measures , and some physical activities ( P < 0.05 ) . Time spent watching TV and participating in non-screen sedentary activities decreased ( P < 0.05 ) . Conclusions The Loozit ® program may be a promising option for stabilizing overweight and improving various metabolic factors , psychological functioning and lifestyle behaviors in overweight adolescents in a community setting .Trial registration Australian New Zeal and Clinical Trials Registry Background Mexico has the highest adult overweight and obesity prevalence in the Americas ; 23.8 % of children < 5 years old are at risk for overweight and 9.7 % are already overweight or obese . Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social ( IMSS ) clinics . Methods We r and omized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care . We recruited 306 parent-child pairs : 168 intervention , 138 usual care . Children were 2 - 5 years old with WHO body mass index ( BMI ) z-score 0 - 3 . We measured children ’s height and weight and parents reported children ’s diet and physical activity at baseline and 3 and 6-month follow-up . We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values . Results 93 ( 55 % ) intervention and 96 ( 70 % ) usual care families completed 3 and 6-month follow-up . At 3 months , intervention v. usual care children increased vegetables by 6.3 servings/week ( 95 % CI , 1.8 , 10.8 ) . In stratified analyses , intervention participants with high program adherence ( 5 - 6 sessions ) decreased snacks and screen time and increased vegetables v. usual care . No further effects on behavioral outcomes or BMI were observed . Transportation time and expenses were barriers to adherence . 90 % of parents who completed the post-intervention survey were satisfied with the program . Conclusions Although satisfaction was high among participants , barriers to participation and retention included transportation cost and time . In intention to treat analyses , we found intervention effects on vegetable intake , but not other behaviors or BMI .Trial registration Clinical Trials.gov NCT01539070.Comisión Nacional de Investigación Científica del IMSS : 2009 - 785 - 120 Peer support among adolescents has been positively associated with heath behaviors ; however , enhancing peer support for weight loss has rarely been studied among adolescents . This study examined whether a peer support training component delivered to enhance a st and ard weight loss program led to improved outcomes . Forty-one overweight adolescent females were r and omly assigned to a St and ard or Enhanced Peer Support intervention . The Enhanced group received in person peer support skills training and practice d skills using social networking . At 16 weeks , participants in the Enhanced condition reported significantly increased perceptions of friend support . Both groups demonstrated significant weight loss ( 6.4 lbs , ± 8.3 ) . Attendance and self-monitoring were associated with weight loss . Perceptions of peer support can be increased with a peer training component , but did not increase weight loss during the short term To decrease BMI in overweight and obese children , improved dietary intake and increased physical activity are key elements . Our objective was to evaluate the impact of a 1-y food and physical activity intervention on energy and macronutrient intake in overweight and obese children . A r and omized open trial was conducted with 92 overweight or obese 10.4 ± 1.08-y-old children . The intervention included 14 group sessions with different themes regarding food and physical activity . Dietary intake was assessed with diet history interviews covering 14 d at baseline and 4-d food records after 1 y and was evaluated according to national dietary recommendations . The control group participated in the same measurements as the intervention group but did not take part in group sessions . After 1 y , both groups had decreased their energy intake ( EI ) relative to total energy expenditure , but the effect was more pronounced for the intervention group than for the control group . At 1 y follow-up , a larger proportion of children in the intervention group compared with the control group met the recommended intake of refined sugar ( P = 0.019 ) . However , the groups did not differ in the proportion children who met the recommended intake of dietary fiber . Further , SFA intake relative to total EI did not differ between the groups at 1 y follow-up . In conclusion , despite a rather comprehensive intervention , only modest effects were achieved with respect to reduced EI and improved macronutrient intake Background / Objectives : To determine if a multi-component family focused education package is more effective than a waiting list control group in treating overweight and obese children . Subjects/ Methods : A 2-year r and omised controlled trial ; 65 overweight and obese children aged 6–14 years were allocated to active intervention in either the first or second year , with body composition monitoring alone in the control period . Anthropometric measurements were undertaken at six monthly intervals and a 7-day food and activity diary were issued . Results : Over the 2 years of the study body mass index ( BMI ) SDS ( z score ) fell significantly in the intervention/control ( I/C ) group , but not in the control/intervention ( C/I ) group . The difference between groups was 0.3 , which was borderline significant ( 95 % confidence interval ( 95 % CI ) −0.62 to 0.02 , P=0.06 ) before adjusting for potential confounding factors . Thirty-three percent of the I/C group and 12 % of the C/I group achieved the target reduction of 0.5 BMI SDS . The I/C group had a significantly greater reduction in the percentage with a BMI above the 99.6th centile at 24 months ( P=0.04 ) and gained 5.7 kg less over the time of the study . There were no significant differences between groups for mean percentage attendance at physical activity sessions ( I/C group=24.1 % , 95 % CI , 15.4–32.9 ; C/I group=31.7 % , 95 % CI , 22.4–41.1 , P=0.229 ) . Conclusions : Children given active intervention followed by body composition monitoring alone reduced their BMI SDS , and fewer children were classified as grossly overweight by the end of the study . If these findings are true , there are important implication s for the provision of services managing overweight in the community OBJECTIVE Maintaining weight loss results in childhood obesity treatment is difficult to achieve . Self-management techniques such as self-monitoring are associated with increased weight loss and maintenance . This study analyzes whether self-monitoring of lifestyle behaviours through a short message service maintenance treatment ( SMSMT ) via mobile phones with personalized feedback positively effects weight , lifestyle behaviours and psychological well-being in obese children . METHODS After 3 months of behavioural lifestyle treatment , 141 overweight and obese children ( 7 - 12 years ) were r and omly assigned to an intervention group receiving SMSMT for 9 months ( n = 73 ) or to the control group ( n = 68 ) . The intervention group sent weekly self-monitoring data on exercise and eating behaviour and their mood via mobile phones . In return , they received tailored feedback messages . Primary treatment outcomes were weight , eating behaviour and psychological well-being , i.e. competence , self-esteem and quality of life . Secondary outcome was adherence to the SMSMT . Data were analyzed with mixed modelling . RESULTS SMSMT did not improve treatment outcomes . Controls gained temporarily in physical health scores ( P = 0.01 ) . SMSMT completers sent on average every 2 weeks an SMS . Children who had greater weight loss during the first 3 months of lifestyle treatment sent more SMSs ( P = 0.04 ) . CONCLUSIONS We did not find a positive effect of SMSMT on weight , eating behaviour or psychological well-being in obese children . SMSMT seems to be a feasible method of treatment delivery . Future research should study variations of SMSMT to investigate how SMSMT can be more effective BACKGROUND Pacific Kids DASH for Health ( PacDASH ) aim ed to improve child diet and physical activity ( PA ) level and prevent excess weight gain and elevation in blood pressure ( BP ) at 9 months . METHODS PacDASH was a two-arm , r and omized , controlled trial ( Clinical Trials.gov : NCT00905411 ) . Eighty-five 5- to 8-year-olds in the 50th-99th percentile for BMI were r and omly assigned to treatment ( n=41 ) or control ( n=44 ) groups ; 62 completed the 9-month trial . Sixty-two percent were female . Mean age was 7.1±0.95 years . Race/ethnicity was Asian ( 44 % ) , Native Hawaiian or Other Pacific Isl and er ( 28 % ) , white ( 21 % ) , or other race/ethnicity ( 7 % ) . Intervention was provided at baseline and 3 , 6 and 9 months , with monthly supportive mailings between intervention visits , and a follow-up visit at 15 months to observe maintenance . Diet and PA were assessed by 2-day log . Body size , composition , and BP were measured . The intervention effect on diet and PA , body size and composition , and BP by the end of the intervention was tested using an F test from a mixed regression model , after adjustment for sex , age , and ethnic group . RESULTS Fruit and vegetable ( FV ) intake decreased less in the treatment than control group ( p=0.04 ) . Diastolic BP ( DBP ) was 12 percentile units lower in the treatment than control group after 9 months of intervention ( p=0.01 ) . There were no group differences in systolic BP ( SBP ) or body size/composition . CONCLUSIONS The PacDASH trial enhanced FV intake and DBP , but not SBP or body size/composition BACKGROUND A school-based obesity prevention study ( Medical College of Georgia FitKid Project ) started in the fall of 2003 in 18 elementary schools . Half of the schools were r and omized to an after-school program that included moderate-to-vigorous physical activity , healthy snacks , homework assistance , and academic enrichment . All third grade rs were invited to enroll . The objective of this study was to assess the cost-effectiveness ( CE ) of the first-year intervention . METHODS St and ard CE analysis methods and a societal perspective were used . Program delivery costs incurred during the first-year intervention and the usual after-school care costs that would occur in the absence of the intervention were estimated ( in 2003 dollars ) . Net intervention costs were calculated by subtracting the usual after-school care costs from the intervention costs . The effectiveness of the intervention was measured as percent body fat ( % BF ) reduction compared with a control condition . The CE was assessed as the net intervention cost divided by the effectiveness of the intervention . RESULTS The intervention costs totaled $ 174,070 , $ 558/student , or $ 956/student who attended > or = 40 % of the intervention sessions . The usual after-school care costs were estimated at $ 639/student . Students who attended > or = 40 % of the intervention reduced % BF by 0.76 % ( 95 % confidence interval : -1.42 to -0.09 ) at an additional cost of $ 317/student . CONCLUSIONS Subjects who attended > or = 40 % of the intervention achieved a significant reduction in % BF at a relatively low cost . School-based obesity prevention programs of this type are likely to be a cost-effective use of public funds and warrant careful consideration by policy makers and program planners This article describes the process of setting up a 3-year , school-based after-school physical activity intervention in elementary schools . The primary aim of the study is to determine whether adiposity and fitness will improve in children who are exposed to a fitogenic versus an obesogenic environment . Eighteen schools were r and omized to the control ( obesogenic ) or intervention ( fitogenic ) group . The study design , program components , and evaluation of the intervention are described in detail . The intervention consists of ( a ) academic enrichment , ( b ) a healthy snack , and ( c ) physical activity in a mastery-oriented environment . Successful implementation would show the feasibility of schools ’ being able to provide a fitogenic environment . Significant differences between the groups would provide evidence that a fitogenic environment after school has positive health benefits . If feasibility and efficacy are demonstrated , implementing an after-school program like this one in elementary schools could play a major role in preventing and reducing childhood obesity Background Reversing the obesity epidemic requires the development and evaluation of childhood obesity intervention programs . Lifestyle Triple P is a parent-focused group program that addresses three topics : nutrition , physical activity , and positive parenting . Australian research has established the efficacy of Lifestyle Triple P , which aims to prevent excessive weight gain in overweight and obese children . The aim of the current r and omized controlled trial is to assess the effectiveness of the Lifestyle Triple P intervention when applied to Dutch parents of overweight and obese children aged 4–8 years . This effectiveness study is called GO4fit . Methods / Design Parents of overweight and obese children are being r and omized to either the intervention or the control group . Those assigned to the intervention condition receive the 14-week Lifestyle Triple P intervention , in which they learn a range of nutritional , physical activity and positive parenting strategies . Parents in the control group receive two brochures , web-based tailored advice , and suggestions for exercises to increase active playing at home . Measurements are taken at baseline , directly after the intervention , and at one year follow-up . Primary outcome measure is the children ’s body composition , operationalized as BMI z-score , waist circumference , and fat mass ( biceps and triceps skinfolds ) . Secondary outcome measures are children ’s dietary behavior and physical activity level , parenting practice s , parental feeding style , parenting style , parental self-efficacy , and body composition of family members ( parents and siblings ) . Discussion Our intervention is characterized by a focus on changing general parenting styles , in addition to focusing on changing specific parenting practice s , as obesity interventions typically do . Strengths of the current study are the r and omized design , the long-term follow-up , and the broad range of both self-reported and objective ly measured outcomes .Trial Registration Current Controlled Trials NTR 2555MEC AzM/UMNL 31988.068.10 / MEC 10 - 3 - OBJECTIVE : This study examined the reduction in overweight and changes in eating-related behaviours in obese children treated with a family-based approach , in which the parents were the exclusive agents of change . Results were compared to the conventional approach in which children are responsible for their own weight loss . DESIGN : A one-year longitudinal prospect i ve design was used . Participants were r and omly allocated for the experimental ( parents as the agents of change ) or the conventional ( children as the agents of change ) intervention . METHODS : Sixty obese children ( 20 % over ideal weight for age , height and gender ) aged 6–11 y ( mean±s.d . 9.2±1.0 y ) were included in the study . Anthropometric measurements and biochemical tests were performed on the children and their parents before and after the programme , and both parents completed a sociodemographic and a family eating and activity habits question naire . Hour-long support/educational sessions were conducted by a clinical dietitian–14 sessions for the parents in the experimental intervention and 30 for the children in the conventional intervention . Individual sessions were held for members of both groups , when necessary . RESULTS : Significant differences were found between the two groups in the reduction of exposure to food stimuli and changes in eating habits ( eating while st and ing , watching TV , reading or doing homework , eating following stress and eating between meals ) . Mean weight reduction ( by percentile ) was significantly greater in the experimental intervention group ( parent-only treatment ) in comparison to the conventional intervention group ( child-only treatment ) . CONCLUSIONS : Treatment of childhood obesity with the parents as the exclusive agents of change , induces more behavioural changes as well as greater weight loss , than the conventional approach Background The prevalence of childhood obesity has increased rapidly during the last three decades in the Netherl and s. It is assumed that mainly environmental factors have contributed to this trend . Parental overweight and low social economic status are risk factors for childhood obesity . Childhood obesity affects self-esteem and has negative consequences on cognitive and social development . Obese children tend to become obese adults , which increases the risk for developing cardiovascular complications , type 2 diabetes mellitus , and psychosocial problems . Additionally , the secretion of several gastrointestinal hormones , responsible for appetite and food intake , is impaired in obese subjects . Weight reduction through lifestyle changes in order to change health risks is , until now , suggested as the preferred treatment for childhood obesity . The objective of this study is the effect evaluation of a family-based cognitive behavioral multidisciplinary lifestyle treatment . The intervention aims to establish long-term weight reduction and stabilization , reduction of obesity-related health consequences and improvement of self-image by change of lifestyle and learning cognitive behavioral techniques . Study design / Methods In this r and omized clinical trial newly presented children with obesity ( 8 - 17 years old ) are divided , by r and omization , in an intervention and control group , both consisting of 40 obese children . The intervention is carried out in groups of 8 - 11 children , and consists of respectively 7 and 5 separate group meetings for the children and their parents and 1 joint group meeting of 2 ½ hours . Main topics are education on nutrition , self-control techniques , social skills , physical activity and improvement of self-esteem . The control group is given advice on physical activity and nutrition . For normal data comparison , data were collected of 40 normal-weight children , 8 - 17 years old . Discussion Because of the increasing prevalence of childhood obesity and the impact on the individual as well as on society , prevention and treatment of obesity in children is of great importance . For evaluation of short- and long-term effects of the treatment , measurements are taken before and after 3 months of treatment , and after 12 and 24 months follow-up . During these visits clinical and biochemical data are determined , cardiovascular fitness tests are performed and quality of life question naires are completed . Trial registration International St and ard R and omised Controlled Trial Number Register IS RCT Objective To evaluate the acceptability and feasibility of a scalable obesity treatment program integrated with pediatric primary care and delivered using interactive voice technology ( IVR ) to families from underserved population s. Design and Methods Fifty parent-child dyads ( child 9–12 yrs , BMI > 95th percentile ) were recruited from a pediatric primary care clinic and r and omized to either an IVR or a wait-list control ( WLC ) group . The majority were lower-income , African-American ( 72 % ) families . Dyads received IVR calls for 12 weeks . Call content was informed by two evidence d-based interventions . Anthropometric and behavioral variables were assessed at baseline and 3 mo follow-up . Results Forty-three dyads completed the study . IVR parents ate 1 cup more fruit than WLC ( p < .05 ) . No other groups differences were found . Children classified as high users of the IVR decreased weight , BMI and BMI z-score compared to low users ( p<.05 ) . Mean number of calls for parents and children were 9.1 ( 5.2 SD ) and 9.0 ( 5.7 SD ) , respectively . Of those who made calls , > 75 % agreed that the calls were useful , made for people like them , credible , and helped them eat healthy foods . Conclusion An obesity treatment program delivered via IVR may be an acceptable and feasible re source for families from underserved population OBJECTIVE To evaluate the efficacy of Motivational Interviewing ( MI ) as an intervention for promoting self-efficacy and weight loss in a sample of overweight and obese youth . METHODS / Design 40 participants ( aged 10 - 18 years ) were r and omly assigned to control ( social skills training ) or treatment ( MI ) group . Both groups received individual therapy ( ~30 min/month ) in addition to usual care of diet/exercise counseling . Pre- and post- ( at 6 months follow-up ) variables included measures of self-efficacy and anthropometrics . RESULTS Although significant between-group differences were not found , individuals in the MI group attended more sessions . Overall , participants in both groups showed significant increases in self-efficacy and a trend of decreased body mass index z-scores . CONCLUSIONS Health benefits from participation in individual therapy may have been accrued ; however , specific benefits attributable to MI were limited . Findings suggest that more than one type of counseling intervention ( i.e. , MI and social skills training ) may be beneficial when providing integrative treatment for obese youth Background The prevention and treatment of childhood obesity is a key public health challenge . However , certain groups within population s have markedly different risk profiles for obesity and related health behaviours . Well- design ed subgroup analysis can identify potential differential effects of obesity interventions , which may be important for reducing health inequalities . The study aim was to evaluate the consistency of the effects of active video games across important subgroups in a r and omised controlled trial ( RCT ) . Findings A two-arm , parallel RCT was conducted in overweight or obese children ( n = 322 ; aged 10–14 years ) to determine the effect of active video games on body composition . Statistically significant overall treatment effects favouring the intervention group were found for body mass index , body mass index z-score and percentage body fat at 24 weeks . For these outcomes , pre-specified subgroup analyses were conducted among important baseline demographic ( ethnicity , sex ) and prognostic ( cardiovascular fitness ) groups . No statistically significant interaction effects were found between the treatment and subgroup terms in the main regression model ( p = 0.36 to 0.93 ) , indicating a consistent treatment effect across these groups . Conclusions Preliminary evidence suggests an active video games intervention had a consistent positive effect on body composition among important subgroups . This may support the use of these games as a pragmatic public health intervention to displace sedentary behaviour with physical activity in young people Background This study evaluates the effects of an intervention performed by youth health care professionals on child health behaviors . The intervention consisted of offering healthy lifestyle counseling to parents of overweight ( not obese ) 5-year-old children . Effects of the intervention on the child having breakfast , drinking sweet beverages , watching television and playing outside were evaluated . Methods Data were collected with the ' Be active , eat right ’ study , a cluster r and omized controlled trial among nine youth health care centers in the Netherl and s. Parents of overweight children received lifestyle counseling according to the intervention protocol in the intervention condition ( n = 349 ) and usual care in the control condition ( n = 288 ) . Parents completed question naires regarding demographic characteristics , health behaviors and the home environment at baseline and at 2-year follow-up . Cluster adjusted regression models were applied ; interaction terms were explored . Results The population for analysis consisted of 38.1 % boys ; mean age 5.8 [ sd 0.4 ] years ; mean BMI SDS 1.9 [ sd 0.4 ] . There were no significant differences in the number of minutes of outside play or television viewing a day between children in the intervention and the control condition . Also , the odds ratio for having breakfast daily or drinking two or less glasses of sweet beverages a day showed no significant differences between the two conditions . Additional analyses showed that the odds ratio for drinking less than two glasses of sweet beverages at follow-up compared with baseline was significantly higher for children in both the intervention ( p < 0.001 ) and the control condition ( p = 0.029 ) . Conclusions Comparison of the children in the two conditions showed that the intervention does not contribute to a change in health behaviors . Further studies are needed to investigate opportunities to adjust the intervention protocol , such as integration of elements in the regular well-child visit . The intervention protocol for youth health care may become part of a broader approach to tackle childhood overweight and obesity . Trial registration Current Controlled Trials IS RCT Background In Lebanon , childhood obesity doubled during the past decade . Preventive measures should start early in life and Schools are considered an important environment to promote energy balance health behaviours . School-based programmes promoting healthy lifestyles are lacking . The purpose of this study was to evaluate the feasibility and effectiveness of a multicomponent school-based intervention to promote healthy eating and physical activity ( and prevent obesity ) with school children aged 9–11 years in Lebanon . Methods The intervention was developed based on the constructs of the Social Cognitive Theory and adapted to the culture of Lebanese and Arab population s. It consisted of three components : class curriculum , family involvement and food service . Eight schools were purposively selected from two communities of different socioeconomic status ( SES ) in Beirut and , within each school type , were matched on SES , religious sect profile , and then r and omly assigned to either the intervention or control group . Anthropometric measurements and question naires on determinants of behavioural change , eating and physical activity habits were completed by the students in both groups at baseline and post intervention . Focus group interviews were conducted in intervention schools at the end of the study . Challenges encountered during the programme implementation were also identified , since Lebanon is considered a country with political unrest and no similar research projects were conducted in the area . Results Students in the intervention group reported purchasing and consuming less chips and sweetened drinks post-intervention compared with controls ( 86 % & 88 % less respectively p < 0.001 ) . Knowledge and self-efficacy scores increased for the intervention ( + 2.8 & + 1.7 points respectively p < 0.001 ) but not for the control group . There was no difference in physical activity and screen time habits and no changes in BMI between groups at post intervention . Interview data from focus groups showed that the programme was generally well accepted . Limitations for better outcomes include the length of the programme and the school environment . Conclusion “ Health-E-PALS ” intervention is a promising innovative , theory-based , culturally sensitive intervention to promote healthy eating habits and physical activity in Lebanese school children with a potential to be scaled up , replicated and sustained BACKGROUND Staged clinical treatment of pediatric obesity is recommended , but untested . Underst and ing the lowest intensity stage 's effectiveness is necessary for future research . METHODS This was a r and omized controlled trial of children ages 4 to < 9 years . Participants were recruited after routine evaluations at a primary care pediatric clinic revealed a BMI ≥85th percentile . The intervention was patterned after the " Prevention plus , Stage 1 " treatment recommended by an expert committee . Groups were compared for changes , over a 3-month time period , in BMI z-score and parental reports of behavioral issues related to childhood obesity using intent-to-treat ( ITT ) analysis . RESULTS Seventy-two ( 30 % of eligible ) children were enrolled and 64 were remeasured at 3-month follow-up . ITT analysis revealed that both groups improved mean BMI z-score [ adjusted change -0.07 , control , and -0.04 , intervention ; 95 % confidence interval ( CI ) of difference=-0.14 - 0.20 ] . Over half of the children in each group improved their BMI z-score ( adjusted proportion decreasing=55 % in control vs. 72 % in intervention ; 95 % CI of difference=-0.07 - 0.42 ) . The intervention group improved comparatively to the control group on numerous behavioral indicators . CONCLUSIONS Implementation of the lowest intensity stage of current recommendations is feasible and possibly of benefit toward lifestyle changes . Results of this study can be used by future clinical research ers design ing protocol s to test the full multi-staged approach for the treatment of pediatric overweight and obesity in primary care clinical setting Objective Evaluating effectiveness and cost-effectiveness of ‘ Families for Health V2′ ( FFH ) compared with usual care ( UC ) . Design Multicentre r and omised controlled trial ( RCT ) ( investigators blinded , families unblinded ) and economic evaluation . Stratified r and omisation by family ; target of 120 families . Setting Three National Health Service Primary Care Trusts in West Midl and s , Engl and . Participants Overweight or obese ( ≥91st or ≥98th centile body mass index ( BMI ) ) children aged 6–11 years and their parents/carers , recruited March 2012–February 2014 . Interventions FFH ; a 10-week community-based family programme addressing parenting , lifestyle change and social and emotional development . UC ; usual support for childhood obesity at each site . Main outcome measures Primary outcomes were 12-months change in children 's BMI z-score and incremental cost per quality -adjusted life-year gained ( QALY ) . Secondary outcomes included changes in children 's physical activity , fruit and vegetable consumption and quality of life , parents ' BMI and mental well-being , family eating/activity , parent-child relationships and parenting style . Results 115 families ( 128 children ) were r and omised to FFH ( n=56 ) or UC ( n=59 ) . There was no significant difference in BMI z-score 12-months change ( 0.114 , 95 % CI −0.001 to 0.229 , p=0.053 ; p=0.026 in favour of UC with missing value multiple imputation ) . One secondary outcome , change in children 's waist z-score , was significantly different between groups in favour of UC ( 0.15 , 95 % CI 0.00 to 0.29 ) . Economic evaluation showed that mean costs were significantly higher for FFH than UC ( £ 998 vs £ 548 , p<0.001 ) . Mean incremental cost-effectiveness of FFH was estimated at £ 552 175 per QALY . Conclusions FFH was neither effective nor cost-effective for the management of obesity compared with UC . Trial registration number IS RCT N45032201 Background Early lifestyle intervention with overweight and obese adolescents could help to avoid serious health events in early adulthood , ultimately alleviating some of the strain on the public health system due to obesity-related morbidity . Commercial weight loss programs have wide reach into the community setting , and have demonstrated success in long term weight management in adults , beyond that of current public health care . Commercial weight-management programs have not been evaluated as a method of delivery for overweight and obese adolescents . This study aims to evaluate the efficacy of a new adolescent weight management program in a commercial environment . Methods One hundred and forty adolescents , 13 to 17 years old , will be r and omised to either a weight management program intervention or a wait-listed group for 12 weeks . The commercial program will consist of a combined dietary and lifestyle approach targeting improved health behaviours for weight-loss or weight-stability . Participants will be overweight or obese ( above the 85th percentile for BMI ) and without existing co-morbidities . Outcome measures will be assessed at baseline and after 12 weeks . Primary outcome measures will be changes in BMI Z-score and waist-height ratio . Secondary outcome measures will include changes in behaviour , physical activity and psychosocial wellbeing . Intervention participants will be followed up at 6 months following completion of the initial program . Ethics approval has been granted from the Monash University Human Research Ethics Committee ( CF11/3687–2011001940 ) . Discussion This independent evaluation of a weight management program for adolescents , delivered in a commercial setting , will provide initial evidence for the effectiveness of such programs ; which may offer adolescents an avenue of weight-management with ongoing support prior to the development of obesity related co-morbidities . Trial registration The protocol for this study is registered with the International Clinical Trials Registry IS RCT N13602313 BACKGROUND Comparative effectiveness research ( CER ) evidence on childhood obesity provides the basis for effective screening and management strategies in pediatric primary care . The uses of health information technology including decision support tools in the electronic health records ( EHRs ) , as well as remote and mobile support to families , offer the potential to accelerate the adoption of childhood obesity CER evidence . METHODS / DESIGN The Study of Technology to Accelerate Research ( STAR ) is a three-arm , cluster-r and omized controlled trial being conducted in 14 pediatric offices in Massachusetts design ed to enroll 800 , 6 to 12 year old children with a body mass index ( BMI ) ≥ 95th percentile seen in primary care at those practice s. We will examine the extent to which computerized decision support tools in the EHR delivered to primary care providers at the point of care , with or without direct-to-parent support and coaching , will increase adoption of CER evidence for management of obese children . Direct-to-parent intervention components include telephone coaching and twice-weekly text messages . Point-of-care outcomes include obesity diagnosis , nutrition and physical activity counseling , and referral to weight management . One-year child-level outcomes include changes in BMI and improvements in diet , physical activity , screen time , and sleep behaviors , as well as cost and cost-effectiveness . CONCLUSIONS STAR will determine the extent to which decision support tools in EHRs with or without direct-to-parent support will increase adoption of evidence -based obesity management strategies in pediatric practice and improve childhood obesity-related outcomes OBJECTIVE : Family-based , behavioral treatment has been shown to be an effective intervention for the management of pediatric obesity . The goal of this study was to compare the cost-effectiveness of two protocol s for the delivery of family-based behavioral treatment . REA SEARCH METHODS AND PROCEDURES : Thirty-one families with obese children were r and omized to groups in which families were provided mixed treatment incorporating both group and individualized treatment vs group treatment only . Cost-effectiveness of treatment was defined as the magnitude of reduction in st and ardized BMI and percentage overweight per dollar spent for recruitment and treatment . Anthropometric data were assessed at baseline , 6 months and 12 months post-r and omization . RESULTS : Results for the 24 families with complete data showed the group intervention was significantly more cost-effective than the mixed treatment . This was due to the similarity between the two groups in Z- BMI or percentage overweight change for children and their parents , while the mixed treatment was significantly more expensive to deliver than the group treatment . DISCUSSION : These findings suggest that a family-based , behavioral intervention employing group treatment alone is a more cost-effective approach to treating pediatric obesity than a mixed group plus individual format Youth with type 1 diabetes ( T1DM ) gain weight after insulin therapy initiation . We aim ed to study the effects of Enhanced Dietary Counseling ( EDC ) compared to St and ard of Care Dietary Counseling ( SDC ) on BMI trajectory in youth with new-onset T1DM . Youth with new-onset T1DM ( n = 47 ; 8.9 + 4.2 years ) were r and omized 6 weeks post-diagnosis to either SDC per American Diabetes Association guidelines ( n = 25 ) or EDC ( n = 22 : SDC plus monthly nutritional education and 3-day food records ( FRs ) at 6 and 24 weeks ) . Weights and heights were measured at diagnosis , 6 weeks , 3 , 6 , and 12 months post-diagnosis ; pre-diagnosis BMI was obtained from pediatricians ’ records . BMI Z score was used to track BMI change . Knowledge of recommended daily energy intake ( DEI ) and daily carbohydrate intake was assessed at follow-up visits . Changes in BMI Z scores were similar in SDC versus EDC subjects from pre-diagnosis to 12 months post-diagnosis . BMI Z score at 12 months exceeded pre-diagnosis level in 58.5 % subjects ( 54.5 % EDC vs. 63.1 % SDC , p = 0.75 ) . From 6 weeks to 6 months , percentage of subjects correctly recalling recommended DEI increased in EDC along with percentage of subjects meeting recommended daily fruit servings intake from 25 % ( 6 weeks ) to 64 % ( 6 months ) , p = 0.047 ) . EDC did not prevent BMI Z score increases in youth with new-onset T1DM , and BMI Z score exceeded pre-diagnosis levels in > 50 % 12 months post-diagnosis . A family-based approach and /or additional intervention may be needed to prevent excessive weight gain OBJECTIVE : This study examined the 24-month outcomes of a r and omized controlled trial of a group-based behavioral weight control ( BWC ) program combined with either activity-based peer intervention or aerobic exercise . METHODS : At baseline , 118 obese adolescents ( 68 % female ; BMI = 31.41 ± 3.33 ) ages 13 to 16 years ( mean = 14.33 ; SD = 1.02 ) were r and omized to receive 1 of 2 weight loss interventions . Both interventions received the same 16-week group-based cognitive-behavioral treatment , combined with either aerobic exercise or peer-based adventure therapy . Eighty-nine adolescents ( 75 % of original sample ) completed the 24-month follow-up . Anthropometric and psychosocial measures were obtained at baseline , at the end of the 16-week intervention , and at 12 and 24 months following r and omization . RESULTS : An intent-to-treat mixed factor analysis of variance indicated a significant effect for time on both percent over 50th percentile BMI for age and gender and st and ardized BMI score , with no differences by intervention group . Post hoc comparisons showed a significant decrease in percent overweight at 4 months ( end of treatment ) , which was maintained at both 12- and 24-month follow-up visits . Significant improvements on several dimensions of self-concept were noted , with significant effects on physical appearance self-concept that were maintained through 24 months . CONCLUSIONS : Both BWC conditions were effective at maintaining reductions in adolescent obesity and improvements in physical appearance self-concept through 24-month follow-up . This study is one of the first to document long-term outcomes of BWC intervention among adolescents Background There is increasing evidence that obesity is related to asthma development and severity . However , it is largely unknown whether weight reduction can influence asthma management , especially in children . Objective To determine the effects of a multifactorial weight reduction intervention on asthma management in overweight/obese children with ( a high risk of developing ) asthma . Methods An 18-month weight-reduction r and omized controlled trial was conducted in 87 children with overweight/obesity and asthma . Every six months , measurements of anthropometry , lung function , lifestyle parameters and inflammatory markers were assessed . Analyses were performed with linear mixed models for longitudinal analyses . Results After 18 months , the body mass index-st and ard deviation score decreased by -0.14±0.29 points ( p<0.01 ) in the intervention group and -0.12±0.34 points ( p<0.01 ) in the control group . This change over time did not differ between groups ( p>0.05 ) . Asthma features ( including asthma control and asthma-related quality of life ) and lung function indices ( static and dynamic ) improved significantly over time in both groups . The FVC% predicted improved over time by 10.1 ± 8.7 % in the intervention group ( p<0.001 ) , which was significantly greater than the 6.1 ± 8.4 % in the control group ( p<0.05 ) . Conclusions & clinical relevance Clinical ly relevant improvements in body weight , lung function and asthma features were found in both the intervention and control group , although some effects were more pronounced in the intervention group ( FVC , asthma control , and quality of life ) . This implies that a weight reduction intervention could be clinical ly beneficial for children with asthma . Trial Registration Clinical Trials.gov OBJECTIVE To determine the efficacy of a 2-year obesity prevention program in African American girls . DESIGN Memphis GEMS ( Girls ' health Enrichment Multi-site Studies ) was a controlled trial in which girls were r and omly assigned to an obesity prevention program or alternative intervention . SETTING Local community centers and YWCAs ( Young Women 's Christian Associations ) in Memphis , Tennessee . PARTICIPANTS Girls aged 8 to 10 years ( N = 303 ) who were identified by a parent or guardian as African American and who had a body mass index ( BMI ) at or higher than the 25th percentile for age or 1 parent with a BMI of 25 or higher . INTERVENTIONS Group behavioral counseling to promote healthy eating and increased physical activity ( obesity prevention program ) or self-esteem and social efficacy ( alternative intervention ) . MAIN OUTCOME MEASURE The BMI at 2 years . RESULTS The BMI increased in all girls with no treatment effect ( obesity prevention minus alternative intervention ) at 2 years ( mean , 0.09 ; 95 % confidence interval [ CI ] , -0.40 to 0.58 ) . Two-year treatment effects in the expected direction were observed for servings per day of sweetened beverages ( mean , -0.19 ; 95 % CI , -0.39 to 0.09 ) , water ( mean , 0.21 ; 95 % CI , 0.03 to 0.40 ) , and vegetables ( mean , 0.15 ; 95 % CI,-0.02 to 0.30 ) , but there were no effects on physical activity . Post hoc analyses suggested a treatment effect in younger girls ( P for interaction = .08 ) . The mean BMI difference at 2 years was -2.41 ( 95 % CI , -4.83 to 0.02 ) in girls initially aged 8 years and -1.02 ( 95 % CI , -2.31 to 0.27 ) in those initially aged 10 years . CONCLUSIONS The lack of significant BMI change at 2 years indicates that this intervention alone is insufficient for obesity prevention . Effectiveness may require more explicit behavior change goals and a stronger physical activity component as well as supportive changes in environmental context Objective : The aim of the study was to compare the efficacy of group treatment stressing a health-promoting lifestyle with routine counseling in the treatment of childhood obesity . Design and subjects : Seventy obese children ( weight for height 115–182 % ) aged 7–9 years were r and omized either to routine counseling ( two appointments for children ) or to family-based group treatment ( 15 separate sessions for parents and children ) . These sessions included nutrition education , physical activity education and behavioral therapy . Outcome measures : Children 's weights and heights were measured at baseline , after the 6-month intervention and after the 6-month follow-up . The change of weight for height based on Finnish growth charts was used as the primary , and changes in body mass index ( BMI ) and BMI st and ard deviation scores ( BMI -SDS ) as secondary outcome measures . Results : Children attending the group treatment lost more weight for height ( 6.8 % ) than children receiving routine counseling ( 1.8 % ) ( P=0.001 ) . The difference was significant when the data were analyzed in four groups by the cut-off limits of 0 , −5 and −10 % for the change in weight for height . The respective decreases in BMI were 0.8 vs 0.0 ( P=0.003 ) and in BMI -SDS 0.3 vs 0.2 ( P=0.022 ) . The results remained similar in adjusted analyses . Both group and routine programs were feasible with a high , 87–99 % , participation rate in sessions and appointments and very low , 3 % or less , attrition rate from the programs . Six months after the intervention , beneficial effects were partly lost , but for changes in weight for height and BMI , the differences between the two treatment programs still were significant , and for BMI -SDS , there was a trend . Conclusions : Family-based group treatment that stresses a health-promoting lifestyle and is given separately for parents and children , offers an effective mode of therapy to treat obese school-aged children INTRODUCTION The negative consequences of unhealthy weight gain and the high likelihood of pediatric obesity tracking into adulthood highlight the importance of targeting youth who are ' at risk ' of obesity . The aim of this paper is to report the rationale and study protocol for the ' Active Teen Leaders Avoiding Screen-time ' ( ATLAS ) obesity prevention intervention for adolescent boys living in low-income communities . METHODS / DESIGN The ATLAS intervention will be evaluated using a cluster r and omized controlled trial in 14 secondary schools in the state of New South Wales ( NSW ) , Australia ( 2012 to 2014 ) . ATLAS is an 8-month multi-component , school-based program informed by self-determination theory and social cognitive theory . The intervention consists of teacher professional development , enhanced school-sport sessions , research er-led seminars , lunch-time physical activity mentoring sessions , pedometers for self-monitoring , provision of equipment to schools , parental newsletters , and a smartphone application and website . Assessment s were conducted at baseline and will be completed again at 9- and 18-months from baseline . Primary outcomes are body mass index ( BMI ) and waist circumference . Secondary outcomes include BMI z-scores , body fat ( bioelectrical impedance analysis ) , physical activity ( accelerometers ) , muscular fitness ( grip strength and push-ups ) , screen-time , sugar-sweetened beverage consumption , resistance training skill competency , daytime sleepiness , subjective well-being , physical self-perception , pathological video gaming , and aggression . Hypothesized mediators of behavior change will also be explored . DISCUSSION ATLAS is an innovative school-based intervention design ed to improve the health behaviors and related outcomes of adolescent males in low-income communities Background United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting . Primary care-based interventions can be effective in improving health behaviors , but also costly . The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity , measured against usual care . Methods High Five for Kids was a cluster-r and omized controlled clinical trial that aim ed to modify children ’s nutrition and TV viewing habits through a motivational interviewing intervention . We assessed visit-related costs from a societal perspective , including provider-incurred direct medical costs , provider-incurred equipment costs , parent time costs and parent out-of-pocket costs , in 2011 dollars for the intervention ( n = 253 ) and usual care ( n = 192 ) groups . We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results . Results The total costs for the intervention group and usual care groups in the first year of the intervention were $ 65,643 ( 95 % CI [ $ 64,522 , $ 66,842 ] ) and $ 12,192 ( 95 % CI [ $ 11,393 , $ 13,174 ] ) . The mean costs for the intervention and usual care groups were $ 259 ( 95 % CI [ $ 255 , $ 264 ] ) and $ 63 ( 95 % CI [ $ 59 , $ 69 ] ) per child , respectively , for a incremental difference of $ 196 ( 95 % CI [ $ 191 , $ 202 ] ) per child . Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls . Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses . Conclusions High Five for Kids was a re source -intensive intervention . Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions .Trial registration Clinical Trials.gov Identifier : NCT00377767 Few r and omized trials attempt to improve insulin sensitivity and associated metabolic risks in overweight Latino youth . The purpose of this study is to examine the effects of a modified carbohydrate nutrition program combined with strength training on insulin sensitivity , adiposity , and other type 2 diabetes risk factors in overweight Latino adolescents . In a 16-week r and omized trial , 54 overweight Latino adolescents ( 15.5 + /- 1.0 years ) were r and omly assigned to : ( i ) Control ( C ; n = 16 ) , ( ii ) Nutrition ( N ; n = 21 ) , or ( iii ) Nutrition + Strength training ( N+ST ; n = 17 ) . The N group received modified carbohydrate nutrition classes ( once per week ) , while the N+ST received the same nutrition classes plus strength training ( twice per week ) . The following were measured at pre- and postintervention : strength by 1-repetition maximum , dietary intake by 3-day records , body composition by dual-energy X-ray absorptiometry , glucose/insulin indices by oral glucose tolerance test ( OGTT ) and intravenous glucose tolerance test with minimal modeling . Across intervention group effects were tested using analysis of covariance with post hoc pairwise comparisons . A significant overall intervention effect was found for improvement in bench press ( P < 0.001 ) and reductions in energy ( P = 0.05 ) , carbohydrate ( P = 0.04 ) and fat intake ( P = 0.03 ) . There were no significant intervention effects on insulin sensitivity , body composition , or most glucose/insulin indices with the exception of glucose incremental area under the curve ( IAUC ) ( P = 0.05 ) , which decreased in the N and N+ST group by 18 and 6.3 % compared to a 32 % increase in the C group . In conclusion , this intense , culturally tailored intervention result ed in no significant intervention effects on measured risk factors with the exception of a beneficial effect on glycemic response to oral glucose CONTEXT No trials for childhood overweight have examined maintenance interventions to augment the effects of initial weight loss programs . OBJECTIVES To determine the short-term and long-term efficacy of 2 distinct weight maintenance approaches vs no continued treatment control following st and ard family-based behavioral weight loss treatment for childhood overweight , and to examine children 's social functioning as a moderator of outcome . DESIGN , SETTING , AND PARTICIPANTS A parallel-group , r and omized controlled trial conducted between October 1999 and July 2004 in a university-based weight control clinic . Participants were 204 healthy 7- to 12-year-olds , 20 % to 100 % above median body mass index ( BMI ) for age and sex , with at least 1 overweight parent . Children enrolled in 5 months of weight loss treatment and 150 were r and omized to 1 of 3 maintenance conditions . Follow-up assessment s occurred immediately following maintenance treatments and 1 and 2 years following r and omization . INTERVENTIONS Maintenance conditions included the control group or 4 months of behavioral skills maintenance ( BSM ) or social facilitation maintenance ( SFM ) treatment . MAIN OUTCOME MEASURES BMI z score and percentage overweight . RESULTS Children receiving either BSM or SFM maintained relative weight significantly better than children assigned to the control group from r and omization to postweight maintenance ( P < or = .01 for all ; effect sizes d = 0.72 - 0.96 ; mean changes in BMI z scores = -0.04 , -0.04 , -0.05 , and 0.05 for BSM alone , SFM alone , BSM and SFM together , and the control group , respectively ) . Active maintenance treatment efficacy relative to the control group declined during follow-up , but the effects of SFM alone ( P = .03 ; d = 0.45 ; mean change in BMI z score = -0.24 ) and when analyzed together with BSM ( P = .04 ; d = 0.38 ; mean change in BMI z score = -0.22 ) were significantly better than the control group ( mean change in BMI z score = -0.06 ) when examining BMI z score outcomes from baseline to 2-year follow-up . Baseline child social problem scores moderated child relative weight change from baseline to 2-year follow-up , with low social problem children in SFM vs the control group having the best outcomes . CONCLUSIONS The addition of maintenance-targeted treatment improves short-term efficacy of weight loss treatment for children relative to no maintenance treatment . However , the waning of effects over follow-up , although moderated by child initial social problems , suggests the need for the bolstering of future maintenance treatments to sustain effects . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00301197 A strategy is needed on how to treat the growing number of obese children with the limited re sources available . We compared the long-term ( 24 months ) effectiveness of therapist-led groups ( TLG ) v. self-help groups ( SHG ) for parents on changes in children 's adiposity and dietary intake . The study included ninety-nine children ( forty-eight girls ) who were referred to obesity treatment ( 7–12 years , BMI z-scores ≥ 2 , attendance of at least one parent ) . Parents ( ninety-one mothers , fifty-four fathers ) were r and omised to TLG aim ed at increasing parents ' competence to accomplish lifestyle changes ( n 47 ) , or SHG ( n 52 ) , both with fifteen sessions . All children participated in children 's groups , and all families attended individual counselling by a clinical dietitian and physiotherapist . Percentage of body fat ( BF ) was measured by dual-energy X-ray absorptiometry , BMI z-score was calculated by international reference values and dietary intake was calculated from 4 d estimated food records at baseline and after 6 and 24 months . No significant between-group differences were detected in the children 's changes in adiposity or dietary intake after 6 and 24 months . BF , BMI z-scores and energy intake were significantly decreased after 6 months ( P < 0·05 ) in both intervention groups , and this persisted throughout 24 months without compromising the diet macronutrient composition . In conclusion , the TLG and SHG intervention groups appear to be equally effective in improving long-term adiposity and dietary intake in obese children . Further research should be performed to clarify whether the SHG should be preferred to parental group treatment for similar children with obesity The effect of increased recreational physical activity in children on insulin levels has not yet been studied . We carried out a r and omized controlled trial in 76 children 6–9 years old , 32 of them increased their physical activity and 30 maintained the same level . In the intervention group , after a week of baseline , recreational activity three times/week was programmed for 12 weeks . We compared insulin , homeostatic model assessment ( HOMA ) index , glucose , HDL-C , LDL-C , triglycerides , and body mass index in both groups . Thereafter , we compared groups of normal weight , overweight , and with obesity in the experimental group . The group of recreational activity increased their median daily steps ( 15,329 to 19,910 ) and decreased insulin ( p < 0.001 ) and HOMA index ( 4.36 vs. 2.39 , p < 0.001 ) . The diminution of insulin levels was more significant in the overweight group ( p < 0.007 ) . In conclusion , in our group , children who increased physical activity during 12 weeks decrease insulin levels and insulin resistance without change in other metabolic and anthropometric variables AIM This study evaluates the efficacy of the Choose Health program , a family-based cognitive behavioural lifestyle program targeting improved eating and activity habits , in improving body composition , cardiovascular fitness , eating and activity behaviours in overweight and obese adolescents . METHOD The sample comprised 29 male and 34 female overweight ( n = 15 ) or obese ( n = 48 ) adolescents aged 11.5 - 18.9 years ( M = 14.3 , SD = 1.9 ) . Participants were r and omly allocated to treatment or waitlist control conditions ; waitlist condition participants were offered treatment after 6 months . DEXA-derived and anthropometric measures of body composition ; laboratory-based cycle ergometer and field-assessed cardiovascular fitness data ; objective and self-report physical activity measures ; and self-report measures of eating habits and 7-day weighed food diaries were used to assess treatment outcome . Adherence to treatment protocol s was high . RESULTS Treatment result ed in significant ( p < .05 ) and sustained improvements in a range of body composition ( body fat , percent body fat , lean mass ) and anthropometric measures ( weight , BMI , BMI -for-age z-score and percentiles ) . Minimal improvements were seen in cardiovascular fitness . Similar results were obtained in completer and intention-to-treat analysis . Poor adherence to assessment protocol s limits conclusions that can be drawn from physical activity and dietary data . CONCLUSIONS Participation in the Choose Health program result ed in significant improvement in body composition . Longer-term follow up is required to determine the durability of intervention effects . Alternative approaches to the measurement of diet and physical activity may be required for adolescents BACKGROUND & AIMS Little is known on the long-term effects of obesity intervention programs in preschool-aged children . We compared the long-term effects of a multidisciplinary treatment program with a usual-care program in seventy-five 3- to 5-year-old overweight or obese children who had participated in a r and omized controlled clinical trial . METHODS A follow-up study collecting data at 18 and 36 months after starting both programs . The multidisciplinary program consisted of diet counseling , exercise sessions teaching motor skills and focusing on an active lifestyle , and psychoeducation for parents . Outcome measures were changes in anthropometry and body composition , determined by bioelectrical impedance analysis and ultrasound . RESULTS At the end of the 16-week treatment program , the multidisciplinary intervention showed a greater decrease in body mass index z score ( BMI -z ) ( mean ( SD ) 0.2 ( 0.1 ) ) and waist circumference z score ( WC-z ) ( mean ( SD ) 0.3 ( 0.1 ) ) , than usual-care . During the 36-month follow-up , a significant overall treatment effect of the multidisciplinary intervention program was demonstrated on BMI -z ( 0.28 , 95 % CI 0.03 - 0.54 ) and abdominal subcutaneous fat ( SCF ) ( 0.23 , 95 % CI 0.01 - 0.45 ) , compared with the usual-care program . CONCLUSIONS A multidisciplinary intervention program in 3- to 5-year-old overweight and obese children shows greater long-term effects on reductions in BMI -z and SCF , compared with a usual-care program OBJECTIVE African-American girls and women are at high risk of obesity and its associated morbidities . Few studies have tested obesity prevention strategies specifically design ed for African-American girls . This report describes the design and baseline findings of the Stanford GEMS ( Girls health Enrichment Multi-site Studies ) trial to test the effect of a two-year community- and family-based intervention to reduce weight gain in low-income , pre-adolescent African-American girls . DESIGN R and omized controlled trial with measurements scheduled in girls ' homes at baseline , 6 , 12 , 18 and 24 month post-r and omization . SETTING Low-income areas of Oakl and , CA . PARTICIPANTS Eight , nine and ten year old African-American girls and their parents/caregivers . INTERVENTIONS Girls are r and omized to a culturally-tailored after-school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education Active-Placebo Comparison intervention . Interventions last for 2 years for each participant . MAIN OUTCOME MEASURE Change in body mass index over the two-year study . RESULTS Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample . Two-hundred sixty one ( 261 ) families were r and omized . One girl per family is r and omly chosen for the analysis sample . R and omization produced comparable experimental groups with only a few statistically significant differences . The sample had a mean body mass index ( BMI ) at the 74 th percentile on the 2000 CDC BMI reference , and one-third of the analysis sample had a BMI at the 95th percentile or above . Average fasting total cholesterol and LDL cholesterol were above NCEP thresholds for borderline high classifications . Girls averaged low levels of moderate to vigorous physical activity , more than 3 h per day of screen media use , and diets high in energy from fat . CONCLUSIONS The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen-time reduction interventions for obesity prevention in low-income , pre-adolescent African-American girls OBJECTIVE : The goal of this study was to evaluate the impact of the Active Teen Leaders Avoiding Screen-time ( ATLAS ) intervention for adolescent boys , an obesity prevention intervention using smartphone technology . METHODS : ATLAS was a cluster r and omized controlled trial conducted in 14 secondary schools in low-income communities in New South Wales , Australia . Participants were 361 adolescent boys ( aged 12–14 years ) considered at risk of obesity . The 20-week intervention was guided by self-determination theory and social cognitive theory and involved : teacher professional development , provision of fitness equipment to schools , face-to-face physical activity sessions , lunchtime student mentoring sessions , research er-led seminars , a smartphone application and Web site , and parental strategies for reducing screen-time . Outcome measures included BMI and waist circumference , percent body fat , physical activity ( accelerometers ) , screen-time , sugar-sweetened beverage intake , muscular fitness , and resistance training skill competency . RESULTS : Overall , there were no significant intervention effects for BMI , waist circumference , percent body fat , or physical activity . Significant intervention effects were found for screen-time ( mean ± SE : –30 ± 10.08 min/d ; P = .03 ) , sugar-sweetened beverage consumption ( mean : –0.6 ± 0.26 glass/d ; P = .01 ) , muscular fitness ( mean : 0.9 ± 0.49 repetition ; P = .04 ) , and resistance training skills ( mean : 5.7 ± 0.67 units ; P < .001 ) . CONCLUSIONS : This school-based intervention targeting low-income adolescent boys did not result in significant effects on body composition , perhaps due to an insufficient activity dose . However , the intervention was successful in improving muscular fitness , movement skills , and key weight-related behaviors BACKGROUND AND OBJECTIVES Social cognitive theory provides the opportunity for program development to enhance healthy personal behvioural characteristics . We devised study to employ social cognitive theory to reduce snacking habits and sedentary activity among overweight adolescents . METHODS AND STUDY DESIGN Eight junior high schools in Makassar city were r and omly assigned as intervention and control schools . A total of 238 overweight students aged 11 - 15 years ( BMI z-score > = 1 SD , according to a 2007 report from the WHO ) were recruited . Adolescents from the intervention schools attended 12 weekly 75-min nutrition education group sessions , which focused on behavioural modification assisted by trained facilitators ; furthermore , their parents received weekly nutrition education leaflets . Adolescents from the control schools , but not their parents , received leaflets on evidence d-based nutrition information . The BMI z-scores , waist circumference , snacking habits , sedentary activity , and the adolescents ' self-efficacy data were assessed prior to and after 3 months of intervention . The outcomes were analysed on an intent-to-treat basis . RESULTS Compared with the control group , the intervention group showed a higher reduction in BMI z-scores ( -0.08 ; p<0.05 ) and waist circumference ( -1.5 ; p<0.05 ) at 3 months . Significant between-group differences were also observed for decreased snacking habits , but not for sedentary activity . Additionally , the programme improved self-efficacy for reducing these behaviours . Mean compliance and satisfaction with the programme were 95 % and 92 % , respectively . CONCLUSIONS These high reduction rates suggest that the programme is promising and may address the problem of overweightness in adolescents . Additional studies are required to develop the programme in community setting BACKGROUND The obesity epidemic has spared no age group , even young infants . Most childhood obesity is incident by the age of 5 years , making prevention in preschool years a priority . OBJECTIVE To examine 2-year changes in age- and sex-specific BMI z-scores and obesity-related behaviours among 441 of the 475 originally recruited participants in High Five for Kids , a cluster r and omized controlled trial in 10 paediatric practice s. METHODS The intervention included a more intensive 1-year intervention period ( four in-person visits and two phone calls ) followed by a less intensive 1-year maintenance period ( two in-person visits ) among children who were overweight or obese and age 2 - 6 years at enrolment . The five intervention practice s restructured care to manage these children including motivational interviewing and educational modules targeting television viewing and intakes of fast food and sugar-sweetened beverages . RESULTS After 2 years , compared with usual care , intervention participants had similar changes in BMI z-scores ( -0.04 units ; 95 % CI -0.14 , 0.06 ) , television viewing ( -0.20 h/d ; -0.49 to 0.09 ) and intakes of fast food ( -0.09 servings/week ; -0.34 to 0.17 ) and sugar-sweetened beverages ( -0.26 servings/day ; -0.67 to 0.14 ) . CONCLUSION High Five for Kids , a primarily clinical -based intervention , did not affect BMI z-scores or obesity-related behaviours after 2 years OBJECTIVE Preschoolers ( ages 2 - 5 years ) have been significantly underrepresented in the obesity treatment outcome literature , despite estimates that 12.1 % are already obese . As such , little is known about the most important intervention targets for weight management within this age group . The aims of this study were ( a ) to examine lifestyle behavior changes for 30 obese preschoolers participating in a weight-control intervention and ( b ) to explore which lifestyle behavior changes predicted changes in body mass index ( BMI ) z score . METHOD Preschooler height , weight , diet ( three 24-hr recalls ) , physical activity ( accelerometry ) , and television use ( parent report ) were measured at baseline and posttreatment ( 6 months ) . A linear regression was conducted to examine pre- to posttreatment changes in diet ( i.e. , intake of calories , sugar-sweetened beverages , fruits and vegetables , and sweet and salty snacks ) and activity ( i.e. , moderate-to-vigorous activity and television use ) behaviors on changes in BMI z score . RESULTS Despite significant reductions in sugar-sweetened beverage intake and television use , and increases in fruit and vegetable intake , only reductions in absolute caloric intake significantly predicted reductions in BMI z score . CONCLUSION Our findings suggest that attaining healthy caloric goals may be the most important component of weight-control interventions for preschoolers . Future research using innovative method ologies , such as the Multiphase Optimization Strategy , may be helpful to prospect ively identifying the lifestyle behavior changes that are most effective in helping families to achieve healthy weight outcomes for preschoolers and thereby improve intervention efficiency and decrease treatment burden for families Background : Treatment studies about childhood obesity in primary care are lacking . We hypothesized that providing a paid family membership to the YMCA would be effective in reducing weight . Methods : Patients 5 to17 years old in at least the 85th body mass index ( BMI ) percentile were eligible . All participants were scheduled to attend 4 nutrition classes and to return for evaluation at 2 , 4 , 6 , 9 , and 12 months . Participants were r and omized to nutrition classes only ( n = 39 ) or nutrition classes and family YMCA membership ( n = 44 ) . The primary outcome measure was year change in BMI -for-age percentile . Results : Median BMI percentile at baseline was 99 . Only 27 of 36 evaluable participants in the treatment group visited the YMCA . Four participants in the control group and one in the treatment group achieved the target reduction of 2 BMI percentile points ( Fisher 's exact , P = .17 ) . Within the treatment group , YMCA attendees had a mean increase of 0.30 BMI points compared with an increase of 0.60 BMI points in nonattendees ( P = .28 ) . Conclusion : In very obese children , eliminating financial barriers to YMCA membership is insufficient to induce more weight loss during 1 year compared with nutrition classes alone . Improvements in nutrition intake were reported by both groups Background Despite record rates of childhood obesity , effective evidence -based treatments remain elusive . While prolonged tertiary specialist clinical input has some individual impact , these services are only available to very few children . Effective treatments that are easily accessible for all overweight and obese children in the community are urgently required . General practitioners are logical care providers for obese children but high- quality trials indicate that , even with substantial training and support , general practitioner care alone will not suffice to improve body mass index ( BMI ) trajectories . HopSCOTCH ( the Shared Care Obesity Trial in Children ) will determine whether a shared-care model , in which paediatric obesity specialists co-manage obesity with general practitioners , can improve adiposity in obese children . Design R and omised controlled trial nested within a cross-sectional BMI survey conducted across 22 general practice s in Melbourne , Australia . Participants Children aged 3–10 years identified as obese by Centers for Disease Control criteria at their family practice , and r and omised to either a shared-care intervention or usual care . InterventionA single multidisciplinary obesity clinic appointment at Melbourne ’s Royal Children ’s Hospital , followed by regular appointments with the child ’s general practitioner over a 12 month period . To support both specialist and general practice consultations , web-based shared-care software was developed to record assessment , set goals and actions , provide information to caregivers , facilitate communication between the two professional groups , and jointly track progress . Outcomes Primary - change in BMI z-score . Secondary - change in percentage fat and waist circumference ; health status , body satisfaction and global self-worth . Discussion This will be the first efficacy trial of a general-practitioner based , shared-care model of childhood obesity management . If effective , it could greatly improve access to care for obese children . Trial Registration Australian New Zeal and Clinical Trials Registry OBJECTIVE : We evaluated the efficacy of family-based , behavioral weight control in the management of severe pediatric obesity . METHODS : Participants were 192 children 8.0 to 12.0 years of age ( mean ± SD : 10.2 ± 1.2 years ) . The average BMI percentile for age and gender was 99.18 ( SD : 0.72 ) . Families were assigned r and omly to the intervention or usual care . Assessment s were conducted at baseline , 6 months , 12 months , and 18 months . The primary outcome was percent overweight ( percent over the median BMI for age and gender ) . Changes in blood pressure , body composition , waist circumference , and health-related quality of life also were evaluated . Finally , we examined factors associated with changes in child percent overweight , particularly session attendance . RESULTS : Intervention was associated with significant decreases in child percent overweight , relative to usual care , at 6 months . Intent-to-treat analyses documented that intervention was associated with a 7.58 % decrease in child percent overweight at 6 months , compared with a 0.66 % decrease with usual care , but differences were not significant at 12 or 18 months . Small significant improvements in medical outcomes were observed at 6 and 12 months . Children who attended ≥75 % of intervention sessions maintained decreases in percent overweight through 18 months . Lower baseline percent overweight , better attendance , higher income , and greater parent BMI reduction were associated with significantly greater reductions in child percent overweight at 6 months among intervention participants . CONCLUSIONS : Intervention was associated with significant short-term reductions in obesity and improvements in medical parameters and conferred longer-term weight change benefits for children who attended ≥75 % of sessions More knowledge about improving dietary intake in secondary preventive actions against childhood overweight and obesity is needed . The objective was to evaluate the impact of a 2-year intervention on energy , macronutrient and food intake of overweight and obese children participating in a r and omised controlled trial . Children ( 8–12 years old ) living in Sweden were recruited to participate for 2 years between 2006 and 2009 . The children were r and omised into either an intervention group ( n 58 ) , participating in an intervention concerning food habits , physical activity and behavioural change , or a control group ( n 47 ) . Dietary intake at baseline and the 2-year measurement were assessed with a diet history interview covering 14 d. Energy intake ( EI ) of the intervention and control groups was underestimated by 28 and 21 % , respectively , after 2 years , but with no difference between the groups ( P = 0·51 ) . After 2 years of intervention , the intervention group , compared with the control group , had a lower intake of sugar-sweetened beverages ( P = 0·015 ) as well as a higher intake of foods high in fibre , low in saturated fat , sugar and salt ( P = 0·031 ) . Further , a lower EI in relation to BMR , lower total fat , MUFA and cholesterol was seen in the intervention group compared with the control group . In conclusion , the food and nutrient intake of overweight and obese children was improved after participating in a 2-year intervention programme . Dietary counselling should be included in secondary preventive actions against childhood overweight and obesity to promote healthy food habits Background Childhood obesity gives rise to health complications including impaired musculoskeletal development that associates with increased risk of fractures . Prevention and treatment programs should focus on nutrition education , increasing physical activity ( PA ) , reducing sedentary behaviours , and should monitor bone mass as a component of body composition . To ensure lifestyle changes are sustained in the home environment , programs need to be family-centered . To date , no study has reported on a family-centered lifestyle intervention for obese children that aims to not only ameliorate adiposity , but also support increases in bone and lean muscle mass . Furthermore , it is unknown if programs of such nature can also favorably change eating and activity behaviors . The aim of this study is to determine the effects of a 1 y family-centered lifestyle intervention , focused on both nutrient dense foods including increased intakes of milk and alternatives , plus total and weight-bearing PA , on body composition and bone mass in overweight or obese children . Methods / design The study design is a r and omized controlled trial for overweight or obese children ( 6–8 y ) . Participants are r and omized to control , st and ard treatment ( StTx ) or modified treatment ( ModTx ) . This study is family-centred and includes individualized counselling sessions on nutrition , PA and sedentary behaviors occurring 4 weeks after baseline for 5 months , then at the end of month 8 . The control group receives counselling at the end of the study . All groups are measured at baseline and every 3 months for the primary outcome of changes in body mass index Z-scores . At each visit blood is drawn and children complete a research er-administered behavior question naire and muscle function testing . Changes from baseline to 12 months in body fat ( % and mass ) , waist circumference , lean body mass , bone ( mineral content , mineral density , size and volumetric density ) , dietary intake , self-reported PA and sedentary behaviour are examined . Discussion This family-centered theory-based study permits for biochemical and physiological assessment s. This trial will assess the effectiveness of the intervention at changing lifestyle behaviours by decreasing adiposity while enhancing lean and bone mass . If successful , the intervention proposed offers new insights for the management or treatment of childhood obesity . Trial registration Clinical Trials.gov , NCT01290016 BACKGROUND Obesity runs in families , and family-based behavioral treatment ( FBT ) is associated with weight loss in overweight/obese children and their overweight/obese parents . This study was design ed to estimate the costs and cost-effectiveness of FBT compared to separate group treatments of the overweight/obese parent and child ( PC ) . METHODS Fifty overweight/obese 8- to 12-year-old children with overweight/obese parents were r and omly assigned to 12 months of either FBT or PC treatment program . Assessment of societal costs ( payer plus opportunity costs ) were completed based on two assumptions : ( 1 ) programs for parent and child were available on separate days ( PC-1 ) or ( 2 ) interventions for parent and child were available in the same location at sequential times on the same day ( PC-2 ) . Cost-effectiveness was calculated based on societal cost per unit of change using percent over BMI for children and weight for parents . RESULTS The average societal cost per family was $ 1,448 for FBT and $ 2,260 for PC-1 ( p < 0.001 ) and $ 2,124 for PC-2 ( p < 0.001 ) . Child cost-effectiveness for FBT was $ 209.17/percent over BMI , compared to $ 1,036.50/percent over BMI for PC-1 and $ 973.98/percent over BMI for PC-2 . Parent cost-effectiveness was $ 132.97/pound ( lb ) for FBT and $ 373.53/lb ( PC-1 ) or $ 351.00/lb ( PC-2 ) . CONCLUSIONS For families with overweight/obese children and parents , FBT presents a lower cost per unit of weight loss for parents and children than treating the parent and child separately . Given the high rates of pediatric and adult obesity , FBT may provide a unique cost-effective platform for obesity intervention that alters weight in overweight/obese parents and their overweight/obese children Background In the evaluation of childhood obesity interventions , few research ers undertake a rigorous feasibility stage in which the design and procedures of the evaluation process are examined . Consequently , phase III studies often demonstrate method ological weaknesses . Purpose Our aim was to conduct a feasibility trial of the evaluation of WATCH IT , a community obesity intervention for children and adolescents . We sought to determine an achievable recruitment rate ; acceptability of r and omisation , assessment procedures , and dropout rate ; optimal outcome measures for the definitive trial ; and a robust sample size calculation . Method Our goal was to recruit 70 participants over 6 months , r and omise them to intervention or control group , and retain participation for 12 months . Assessment s were taken prior to r and omisation and after 6 and 12 months . Procedures mirrored those intended for a full-scale trial , but multiple measures of similar outcomes were included as a means to determine those most appropriate for future research . Acceptability of the research and impact of the research on the programme were ascertained through interviewing participants and staff . Results We recruited 70 participants and found that r and omisation and data collection procedures were acceptable . Self-referral ( via media promotion ) was more effective than professional referral . Blinding of assessors was sustained to a reasonable degree , and optimal outcome measures for a full-scale trial were identified . Estimated sample size was significantly greater than sample sized reported in published trials . There was some negative impact on the existing programme as a result of the research , a lesson for design ers of future trials . Limitations We successfully recruited socially disadvantaged families , but the majority of families were of White British nationality . The composition of the participants was an added valuable lesson , suggesting that recruitment strategies to obtain a more heterogeneous ethnic sample warrant consideration in future research . Conclusions This study provided us with confidence that we can run a phase III multi-centre trial to test the effectiveness of WATCH IT . Importantly , it was invaluable in informing the design not only of that trial but also of future evaluations of childhood obesity treatment interventions BACKGROUND The association of changes in oxidative and proinflammatory states with vascular function after diet and exercise intervention among obese children has not been previously explored . METHODS In this 6-week diet and exercise intervention study in 35 obese children , age 12 to 18 years , we evaluated the relationship between changes in anthropometric indices , measures of insulin resistance , C-reactive protein ( CRP ) , oxidized LDL ( ox-LDL ) , and oxidative stress markers with changes in carotid intima-media thickness ( C-IMT ) and flow mediated dilation ( FMD ) of the brachial artery . RESULTS At the end of the study , body mass index ( BMI ) , waist circumference , and percentage body fat were decreased ( P < 0.05 ) , but participants remained overweight ( BMI > or = 95th percentile ) . Although FMD improved ( P < 0.05 ) , the improvement in C-IMT did not reach statistical significance . The changes in BMI , waist circumference , fat mass , ox-LDL , malondialdehyde ( MDA ) , CRP , insulin , and homeostasis model assessment for insulin resistance ( HOMA-IR ) had an inverse correlation with the changes in mean FMD after adjustment for age and sex , with the highest correlations documented for ox-LDL , CRP , and WC . The age- and sex-adjusted changes in ox-LDL , waist circumference , CRP , MDA , and body fat mass had the highest correlations with changes in C-IMT . CONCLUSIONS Our findings suggest that a common inflammatory stress condition associated with childhood obesity , notably with abdominal fat deposition , may play a role in the development of the earliest stages of proatherosclerotic inflammatory processes and subsequent vascular dysfunction . These changes might be partially reversible by short-term diet and exercise intervention , even if patients do not reach ideal body weight Background Because parental recognition of overweight in young children is poor , we need to determine how best to inform parents that their child is overweight in a way that enhances their acceptance and supports motivation for positive change . This study will assess 1 ) whether weight feedback delivered using motivational interviewing increases parental acceptance of their child 's weight status and enhances motivation for behaviour change , and 2 ) whether a family-based individualised lifestyle intervention , delivered primarily by a MInT mentor with limited support from " expert " consultants in psychology , nutrition and physical activity , can improve weight outcomes after 12 and 24 months in young overweight children , compared with usual care . Methods / Design 1500 children aged 4 - 8 years will be screened for overweight ( height , weight , waist , blood pressure , body composition ) . Parents will complete question naires on feeding practice s , physical activity , diet , parenting , motivation for healthy lifestyles , and demographics . Parents of children classified as overweight ( BMI ≥ CDC 85th ) will receive feedback about the results using Motivational interviewing or Usual care . Parental responses to feedback will be assessed two weeks later and participants will be invited into the intervention . Additional baseline measurements ( accelerometry , diet , quality of life , child behaviour ) will be collected and families will be r and omised to Tailored package or Usual care . Parents in the Usual care condition will meet once with an advisor who will offer general advice regarding healthy eating and activity . Parents in the Tailored package condition will attend a single session with an " expert team " ( MInT mentor , dietitian , physical activity advisor , clinical psychologist ) to identify current challenges for the family , develop tailored goals for change , and plan behavioural strategies that best suit each family . The mentor will continue to provide support to the family via telephone and in-person consultations , decreasing in frequency over the two-year intervention . Outcome measures will be obtained at baseline , 12 and 24 months . Discussion This trial offers a unique opportunity to identify effective ways of providing feedback to parents about their child 's weight status and to assess the efficacy of a supportive , individualised early intervention to improve weight outcomes in young children . Trial registration Australian New Zeal and Clinical Trials Registry BACKGROUND AND OBJECTIVE : Motivational interviewing ( MI ) has been shown to be an effective strategy for targeting obesity in adolescents , and parental involvement is associated with increased effectiveness . The aim of this study was to evaluate and compare the role of parental involvement in MI interventions for obese adolescents . METHODS : A total of 357 Iranian adolescents ( aged 14–18 years ) were r and omized to receive an MI intervention or an MI intervention with parental involvement ( MI + PI ) or assessment s only ( passive control ) . Data regarding anthropometric , biochemical , psychosocial , and behavioral measures were collected at baseline and 12 months later . A series of intention-to-treat , 2-way repeated- measures analysis of covariance were performed to examine group differences in change in outcomes measures over the 12-month follow-up period . RESULTS : Results revealed significant effects on most of the outcome parameters for MI + PI ( eg , mean ± SD BMI z score : 2.58 ± 0.61 ) compared with the passive control group ( 2.76 ± 0.70 ; post hoc test , P = .02 ) , as well as an additional superiority of MI + PI compared with MI only ( 2.81 ± 0.76 ; post hoc test , P = .05 ) . This pattern was also shown for most of the anthropometric , biochemical , psychometric , and behavioral outcome variables . CONCLUSIONS : MI with parental involvement is an effective strategy in changing obesity-related outcomes and has additional effects beyond MI with adolescents only . These findings might be important when administering MI interventions in school setting Background Adolescents with overweight and poor physical fitness have an increased likelihood of developing cardiovascular diseases during adulthood . In Ecuador , a health promotion program improved the muscular strength and speed-agility , and reduced the decline of the moderate-to-vigorous physical activity of adolescents after 28 months . We performed a sub-group analysis to assess the differential effect of this intervention in overweight and low-fit adolescents . Methods We performed a cluster-r and omized pair matched trial in schools located in Cuenca – Ecuador . In total 20 schools ( clusters ) were pair matched , and 1440 adolescents of grade 8 and 9 ( mean age of 12.3 and 13.3 years respectively ) participated in the trial . For the purpose s of the subgroup analysis , the adolescents were classified into groups according to their weight status ( body mass index ) and aerobic capacity ( scores in the 20 m shuttle run and FITNESSGRAM st and ards ) at baseline . Primary outcomes included physical fitness ( vertical jump , speed shuttle run ) and physical activity ( proportion of students achieving over 60 min of moderate – to-vigorous physical activity/day ) . For these primary outcomes , we stratified analysis by weight ( underweight , normal BMI and overweight/obese ) and fitness ( fit and low fitness ) groups . Mixed linear regression models were used to assess the intervention effect . Results The prevalence of overweight/obesity , underweight and poor physical fitness was 20.3 % , 5.8 % and 84.8 % respectively . A higher intervention effect was observed for speed shuttle run in overweight ( β = −1.85 s , P = 0.04 ) adolescents compared to underweight ( β = −1.66 s , P = 0.5 ) or normal weight ( β = −0.35 s , P = 0.6 ) peers . The intervention effect on vertical jump was higher in adolescents with poor physical fitness ( β = 3.71 cm , P = 0.005 ) compared to their fit peers ( β = 1.28 cm , P = 0.4 ) . The proportion of students achieving over 60 min of moderate-to-vigorous physical activity/day was not significantly different according to weight or fitness status . Conclusion Comprehensive school-based interventions that aim to improve diet and physical activity could improve speed and strength aspects of physical fitness in low-fit and overweight/obese adolescents . Trial registration Clinical trials.gov identifier NCT01004367 . Registered October 28 , 2009 OBJECTIVE To examine the efficacy of an interactive , child-centred and family-based program in promoting healthy weight and healthy lifestyles in Chinese American children . DESIGN A r and omized controlled study of a culturally sensitive behavioral intervention . SUBJECTS Sixty-seven Chinese American children ( ages , 8 - 10 years ; normal weight and overweight ) and their families . MEASUREMENTS Anthropometry , blood pressure , measures of dietary intake , physical activity , knowledge and self-efficacy regarding physical activity and diet at baseline and 2 , 6 and 8 months after baseline assessment . RESULTS Linear mixed modeling indicated a significant effect of the intervention in decreasing body mass index , diastolic blood pressure and fat intake while increasing vegetable and fruit intake , actual physical activity and knowledge about physical activity . CONCLUSION This interactive child-centred and family-based behavioral program appears feasible and effective , leading to reduced body mass index and improved overweight-related health behaviors in Chinese American children . This type of program can be adapted for other minority ethnic groups who are at high risk for overweight and obesity and have limited access to programs that promote healthy lifestyles Background . The aim was to evaluate the effects of a 12-week , Facebook-delivered lifestyle counselling intervention , with or without physical activity self-monitoring , on physical activity and body mass index ( BMI ) in overweight and obese 13–16-year-old adolescents . Methods . Three-arm r and omized controlled trial . Participants ( n = 46 ) were r and omly assigned to intervention and control groups : one group received Facebook-delivered lifestyle counselling and monitoring of their physical activity ( Fb + Act , n = 15 ) , whereas a second experimental group received the same Facebook-delivered lifestyle counselling without self-monitoring ( Fb , n = 16 ) and a third group served as the control group ( n = 15 ) . Objective and self-reported physical activity assessment were used . Nonparametric statistical tests were used . Results . There were no significant intervention effects in terms of changes in physical activity levels or BMI from baseline to the 12-week postintervention measurements between the intervention and control groups . The Fb + Act group had lower sedentary time on weekdays compared to the control group during postintervention measurements ( p = 0.021 ) , but there was no interaction between time and group . Conclusions . Interventions were not effective at increasing physical activity in overweight and obese adolescents . Before implementing such interventions , more evaluations on their effectiveness are needed . This trial is registered with Clinical Trials.gov identifier NCT02295761 ( 2014 - 11 - 17 ) OBJECTIVE : To test in the primary care setting the short- and long-term efficacy of a behavioral intervention that simultaneously targeted an overweight child and parent versus an information control ( IC ) targeting weight control only in the child . METHODS : Two- to 5-year-old children who had BMI ≥85th percentile and an overweight parent ( BMI > 25 kg/m2 ) were r and omized to Intervention or IC , both receiving diet and activity education over 12 months ( 13 sessions ) followed by 12-month follow-up ( 3 sessions ) . Parents in the Intervention group were also targeted for weight control and received behavioral intervention . Pediatricians in 4 practice s enrolled their patients with the assistance of embedded recruiters ( Practice Enhancement Assistants ) who assisted with treatment too . RESULTS : A total of 96 of the 105 children r and omized ( Intervention n = 46 ; IC n = 50 ) started the program and had data at baseline . Children in the Intervention experienced greater reductions in percent over BMI ( group × months ; P = .002 ) and z- BMI ( group × months ; P < 0.001 ) compared with IC throughout treatment and follow-up . Greater BMI reduction was observed over time for parents in the Intervention compared with IC ( P < .001 ) throughout treatment and follow-up . Child weight changes were correlated with parent weight changes at 12 and 24 months ( r = 0.38 and 0.26 ; P < .001 and P = .03 ) . CONCLUSIONS : Concurrently targeting preschool-aged overweight and obese youth and their parents in primary care with behavioral intervention results in greater decreases in child percent over BMI , z- BMI , and parent BMI compared with IC . The difference between Intervention and IC persists after 12 months of follow-up Background Few r and omised controlled trials ( RCTs ) of interventions for the treatment of adolescent obesity have taken place outside the western world . This RCT tested whether a simple ‘ good practice ’ intervention for the treatment of adolescent obesity would have a greater impact on weight status and other outcomes than a referral to primary care ( control ) in adolescents in Kuwait City . Methods We report on an assessor-blinded RCT of a treatment intervention in 82 obese 10- to 14-year-olds ( mean age 12.4 , SD 1.2 years ) , r and omised to a good practice treatment or primary care control group over 6 months . The good practice intervention was intended as relatively low intensity ( 6 hours contact over 24 weeks , group-based ) , aim ing to change sedentary behaviour , physical activity , and diet . The primary outcome was a change in body mass index ( BMI ) Z score ; other outcomes were changes in waist circumference and blood pressure . Results The retention of subjects to follow up was acceptable ( n = 31 from the intervention group , and n = 32 from the control group ) , but engagement with both the intervention and control treatment was poor . Treatment had no significant effect on BMI Z score relative to control , and no other significant benefits to intervention were observed . Conclusions The trial was feasible , but highlights the need to engage obese adolescents and their families in the interventions being trialled . The trial should inform the development of future adolescent obesity treatment trials in the Gulf States with the incorporation of qualitative assessment in future intervention trials . Trial registration RCT Registered as National Adolescent Treatment Trial for Obesity in Kuwait (NATTO):http://www.controlled-trials.com/IS RCT N37457227 , 1 December 2009 OBJECTIVE : To determine if an intervention for preschool-aged children in primary care is effective in reducing screen time , meals in front of the television , and BMI . METHODS : A r and omized controlled trial was conducted at a primary care pediatric group practice in Toronto , Canada . Three-year-old children and their parents were r and omly assigned to receive a short behavioral counseling intervention on strategies to decrease screen time . The primary outcome 1 year later was parent reported screen time . Secondary outcomes included television in the child ’s bedroom , number of meals in front of the television , and BMI . RESULTS : In the intention-to-treat analysis at 1 year , there were no significant differences in mean total weekday minutes of screen time ( 60 , interquartile range [ IQR ] : 35–120 vs 65 , IQR : 35–120 ; P = .68 ) or mean total weekend day minutes of screen time ( 80 , IQR : 45–130 vs 90 , IQR : 60–120 ; P = .33 ) between the intervention and control group . Adjusting for baseline BMI , there was a reduction in the number of weekday meals in front of the television ( 1.6 ± 1.0 vs 1.9 ± 1.2 ; P = .03 ) but no differences in BMI or number of televisions in the bedroom . CONCLUSIONS : This pragmatic trial was not effective in reducing screen time or BMI but was effective in reducing meals in front of the screen . Short interventions focused solely on reducing screen time implemented in the primary care practice setting may not be effective in this age group The aim of the Bright Start study was to develop and test the effectiveness of a school environment intervention , supplemented with family involvement , to reduce excessive weight gain by increasing physical activity and healthy eating practice s among kindergarten and first grade American Indian children . Bright Start was a group-r and omized , school-based trial involving 454 children attending 14 schools on the Pine Ridge Reservation in South Dakota . Children were followed from the beginning of their kindergarten year through the end of first grade . Main outcome variables were mean BMI , mean percent body fat , and prevalence of overweight/obese children . The goals of the intervention were to : increase physical activity at school to at least 60 min/day ; modify school meals and snacks ; and involve families in making behavioral and environmental changes at home . At baseline , 32 % of boys and 25 % of girls were overweight/obese . While the intervention was not associated with statistically significant change in mean levels of BMI , BMI -Z , skinfolds or percentage body fat , the intervention was associated with a statistically significant net decrease of 10 % in the prevalence of overweight . Intervention children experienced a 13.4 % incidence of overweight , while the control children experienced a corresponding incidence of 24.8 % ; a difference of −11.4 % ( p=0.033 ) . The intervention significantly reduced parent reported mean child intakes of sugar-sweetened beverages , whole milk and chocolate milk . Changes in duration of school physical activity were not significant . Because obesity is the most daunting health challenge facing American Indian children today , more intervention research is needed to identify effective approaches Introduction Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children . The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherl and s. Method We used a parallel r and omized controlled design to test the effectiveness of the intervention . In total , 86 child-parent triads ( children 4–8 years old , overweight or obese ) were recruited and r and omly assigned ( allocation ratio 1:1 ) to the Lifestyle Triple P intervention or the control condition . Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions . Primary outcome measure was the children ’s body composition ( BMI z-scores , waist circumference and skinfolds ) . The research assistant who performed the measurements was blinded for group assignment . Secondary outcome measures were the children ’s dietary behavior and physical activity level , parenting practice s , parental feeding style , parenting style , and parental self-efficacy . Outcome measures were assessed at baseline and 4 months ( short-term ) and 12 months ( long-term ) after baseline . Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures . Results No intervention effects were found on children ’s body composition . Analyses of secondary outcomes showed positive short-term intervention effects on children ’s soft-drink consumption and parental responsibility regarding physical activity , encouragement to eat , psychological control , and efficacy and satisfaction with parenting . Longer-term intervention effects were found on parent ’s report of children ’s time spent on sedentary behavior and playing outside , parental monitoring food intake , and responsibility regarding nutrition . Conclusion Although the Lifestyle Triple P intervention showed positive effects on some parent reported child behaviors and parenting measures , no effects were visible on children ’s body composition or objective ly measured physical activity . Several adjustments of the intervention content are recommended , for example including a booster session . Trial Registration Nederl and s Trial Register NTR Background A poor underst and ing of the specific lifestyle behaviors that result in weight loss has hindered the development of effective interventions . The aim of this paper was to identify potential behavioral mediators of weight loss in the Healthy Dads , Healthy Kids ( HDHK ) intervention for overweight fathers . Findings The three-month intervention was evaluated in a r and omized controlled trial and conducted in Newcastle , New South Wales , Australia . Baseline , three month ( immediate post-intervention ) and six month assessment s were conducted . Recruitment and follow-up occurred between October 2008 and May 2009 . The study sample included 53 overweight/obese men [ mean ( SD ) age=40.6 ( 97.1 ) years ; body mass index ( BMI ) = 33.2 ( 3.9 ) kgm-2 ] and their primary school-aged children [ n=71 , 54 % boys ; age=8.2 ( 2.0 ) years ] who were r and omized to HDHK program or a wait-list control group . Physical activity ( PA ) was assessed using pedometers and dietary behaviors were measured using a vali date d food frequency question naire . The intervention result ed in significant weight loss ( 5.131.27 kg , P<0.0001 ) and increased PA among fathers ( 2769750 steps/day , P<0.001 ) and their children ( 1486521 steps/day , P<0.01 ) . Fathers PA mediated weight loss in the intervention ( AB=2.31 , 95 % CI=4.63 to 0.67 ) and was responsible for 47 % of the intervention effect . Changes in dietary behaviors were not statistically significant . Conclusions PA was an important mediator of weight loss in the HDHK intervention . Encouraging overweight fathers to be more active with their children appears to be a promising strategy for obesity treatment in men BACKGROUND AND OBJECTIVE : Few studies have tested the impact of motivational interviewing ( MI ) delivered by primary care providers on pediatric obesity . This study tested the efficacy of MI delivered by providers and registered dietitians ( RDs ) to parents of overweight children aged 2 through 8 . METHODS : Forty-two practice s from the Pediatric Research in Office Setting s Network of the American Academy of Pediatrics were r and omly assigned to 1 of 3 groups . Group 1 ( usual care ) measured BMI percentile at baseline and 1- and 2-year follow-up . Group 2 ( provider only ) delivered 4 MI counseling sessions to parents of the index child over 2 years . Group 3 ( provider + RD ) delivered 4 provider MI sessions plus 6 MI sessions from a RD . The primary outcome was child BMI percentile at 2-year follow up . RESULTS : At 2-year follow-up , the adjusted BMI percentile was 90.3 , 88.1 , and 87.1 for groups 1 , 2 , and 3 , respectively . The group 3 mean was significantly ( P = .02 ) lower than group 1 . Mean changes from baseline in BMI percentile were 1.8 , 3.8 , and 4.9 across groups 1 , 2 , and 3 . CONCLUSIONS : MI delivered by providers and RDs ( group 3 ) result ed in statistically significant reductions in BMI percentile . Research is needed to determine the clinical significance and persistence of the BMI effects observed . How the intervention can be brought to scale ( in particular , how to train physicians to use MI effectively and how best to train RDs and integrate them into primary care setting s ) also merits future research Background There is increasing evidence for the effectiveness of parental support programmes to promote healthy behaviours and prevent obesity in children , but only few studies have been conducted among groups with low socio-economic status . The aim of this study was to develop and evaluate the effectiveness of a parental support programme to promote healthy dietary and physical activity habits and to prevent overweight and obesity in six-year-old children in disadvantaged areas . Methods A cluster-r and omised controlled trial was carried out in disadvantaged areas in Stockholm . Participants were six-year-old children ( n = 378 ) and their parents . Thirty-one school classes from 13 schools were r and omly assigned to intervention ( n = 16 ) and control groups ( n = 15 ) . The intervention lasted for 6 months and included : 1 ) Health information for parents , 2 ) Motivational Interviewing with parents and 3 ) Teacher-led classroom activities with children . Physical activity was measured by accelerometry , dietary intake and screen time with a question naire , body weight and height were measured and BMI st and ard deviation score was calculated . Measurements were conducted at baseline , post-intervention and at 5months follow-up . Group effects were examined using Mixed-effect Regression analyses adjusted for sex , parental education and baseline values . Results Fidelity to all three intervention components was satisfactory . Significant intervention effects were found regarding consumption of unhealthy foods ( p = 0.01 ) and unhealthy drinks ( p = 0.01 ) . At follow-up , the effect on intake of unhealthy foods was sustained for boys ( p = 0.03 ) . There was no intervention effect on physical activity . Further , the intervention had no apparent effect on BMI sds for the whole sample , but a significant difference between groups was detected among children who were obese at baseline ( p = 0.03 ) which was not sustained at follow-up . Conclusions The Healthy School Start study shows that it is possible to influence intake of unhealthy foods and drinks and weight development in obese children by providing individual parental support in a school context . However , the effects were short-lived . Therefore , the programme needs to be prolonged and /or intensified in order to obtain stronger and sustainable effects . This study is an important contribution to the further development of evidence -based parental support programmes to prevent overweight and obesity in children in disadvantaged areas Nutritional counseling for children with obesity is an important component of management . This r and omized controlled trial was conducted to compare change in body mass index ( BMI ) z score after 6 months . Children 8 to 16 years with a BMI greater than the 85th percentile were r and omized to st and ard of care nutrition counseling versus intervention with st and ard nutrition counseling including portion control tool training for the family . Measures were completed at baseline , 3 months , and 6 months . Fifty-one children were r and omized to control and 48 to intervention . Mean age was 11 years ( SD = 2.2 ) . Mean BMI z score was 2.7 ( SD = 0.4 ) . Forty-five percent were male ( n = 45 ) . Follow-up at 6 months was 73.7 % ( 73/99 ) . Although no differences were seen between the groups , there was a significant decrease in BMI z score between baseline and 6 months within each group OBJECTIVE : The aim of this study was to evaluate the effect of family pediatrician – led motivational interviews ( MIs ) on BMI of overweight ( 85th ≥ BMI percentile ≥95th ) children aged 4 to 7 years . METHODS : All the family pediatricians working in Reggio Emilia Province ( Italy ) were invited to participate in the study ; 95 % accepted . Specific training was provided . Parents were asked to participate in the trial if they recognized their child as overweight . Children were individually r and omly assigned to MIs or usual care . All children were invited for a baseline and a 12-month visit to assess BMI and lifestyle behaviors . The usual care group received an information leaflet , and the intervention group received 5 MI family meetings . The primary outcome was the individual variation of BMI , assessed by pediatricians unblinded to treatment groups . RESULTS : Of 419 eligible families , 372 ( 89 % ) participated ; 187 children were r and omized to MIs and 185 to the usual care group . Ninety-five percent of the children attended the 12-month visit . The average BMI increased by 0.49 and 0.79 during the intervention in the MI and control groups , respectively ( difference : –0.30 ; P = .007 ) . MI had no effect in boys or in children whose mothers had a low educational level . Positive changes in parent-reported lifestyle behaviors occurred more frequently in the MI group than in the control group . CONCLUSIONS : The pediatrician-led MI was overall effective in controlling BMI in these overweight children aged 4 to 7 years , even though no effect was observed in male children or when the mother ’s education level was low OBJECTIVE —To evaluate the impact on glucose metabolism of a lifestyle program ( the Yale Bright Bodies Program ) for obese children . RESEARCH DESIGN AND METHODS —Thirteen Bright Bodies and ten clinic-care control subjects who were part of a large r and omized clinical trial had 75-g oral glucose tolerance tests at the beginning and end of the 12-month study . RESULTS —Bright Bodies subjects had significantly greater decreases in weight , BMI , and body fat than clinic-care subjects , and the Bright Body subjects ’ changes in body composition were accompanied by marked improvements in insulin sensitivity ( P = 0.009 ) and glucose tolerance ( P = 0.04 ) . CONCLUSIONS —An intensive lifestyle program that successfully reduces body weight and body fat can markedly improve insulin sensitivity and glucose metabolism in obese youth CONTEXT Retinol binding protein ( RBP4 ) , secreted primarily from the liver and adipose tissues , was recently proposed as a link between obesity and insulin resistance . The role of RBP4 in pediatric obesity , its relationship with sub clinical inflammation , and its response to lifestyle changes are not eluci date d. OBJECTIVE The objective of the study was to determine in children : 1 ) the status of RBP4 levels in lean vs. obese ; 2 ) the relationship between RBP4 levels and sub clinical inflammation ; and 3 ) the effect of lifestyle-only intervention on RBP4 levels . DESIGN , SETTING , AND PATIENTS Lean and obese children ( n = 21 ) matched for age ( > 14 yr to < 18 yr ) and maturity stage ( Tanner IV ) were studied at baseline and with lifestyle intervention in obese subjects only ( n = 15 ) . INTERVENTION Patients received 3 months of r and omized and controlled physical activity-based lifestyle intervention . MAIN OUTCOME MEASURE RBP4 levels in children before and after intervention and the relationship between RBP4 and sub clinical inflammation were measured . RESULTS Higher RBP4 levels were found in the obese group vs. lean group ( P = 0.005 ) . RBP4 correlated with not only indices of obesity and insulin resistance but also inflammatory factors ( r = 0.63 and 0.64 for C-reactive protein and IL-6 , respectively , P < 0.01 ) . Intervention reduced RBP4 levels by approximately 30 % ( P = 0.001 ) , and RBP4 reduction was correlated with the magnitude of decrease in inflammatory factors ( P = 0.01 ) . CONCLUSION Alterations in serum RBP4 occur at an early age in the clinical course of obesity and appear to correlate with sub clinical inflammation . Lifestyle intervention almost entirely reversed the raised RBP4 levels in obese children . Future studies should determine whether elevation of RBP4 is a direct trigger for the insulin resistance and sub clinical inflammation implicated in the premature development of cardiovascular disease and diabetes OBJECTIVE To develop a home-based intervention for parents of 2 - 5 year old children to promote household routines to prevent overweight/obesity . METHODS We recruited 121 children from health centers in Boston between 2011 and 2012 and r and omized 62 to intervention and 59 to the control condition . The 6-month intervention included 1 ) motivational coaching at home and by phone with a health educator , 2 ) mailed educational material s , and 3 ) weekly text messages . The intervention promoted three household routines : eating meals as a family , obtaining adequate sleep , and limiting screen time . RESULTS Of the 121 children , mean ( SD ) age was 4.0 ( 1.1 ) years ; 52 % were Hispanic , 34 % Black , and 14 % White/Other . Nearly 60 % of the sample had annual household incomes ≤ $ 20,000 . Approximately 64 % of families reported eating together ≥ 7 times per week , however , many meals were eaten in front of a TV . Over half of the children slept less than the recommended 11h/night and 78 % viewed ≥ 2 h/day of screen time . CONCLUSIONS Household routines that increase obesity risk were prevalent among low-income families in this study . If proven to be effective , promotion of household routines related to family meals , sleep , and screen time may prevent young children from becoming overweight/obese BACKGROUND The Connect for Health study is design ed to assess whether a novel approach to care delivery that leverages clinical and community re sources and addresses socio- context ual factors will improve body mass index ( BMI ) and family-centered , obesity-related outcomes of interest to parents and children . The intervention is informed by clinical , community , parent , and youth stakeholders and incorporates successful strategies and best practice s learned from ' positive outlier ' families , i.e. , those who have succeeded in changing their health behaviors and improve their BMI in the context of adverse built and social environments . DESIGN Two-arm , r and omized controlled trial with measures at baseline and 12 months after r and omization . PARTICIPANTS 2 - 12 year old children with overweight or obesity ( BMI ≥ 85th percentile ) and their parents/guardians recruited from 6 pediatric practice s in eastern Massachusetts . INTERVENTION Children r and omized to the intervention arm receive a context ually-tailored intervention delivered by trained health coaches who use advanced geographic information system tools to characterize children 's environments and neighborhood re sources . Health coaches link families to community-level re sources and use multiple support modalities including text messages and virtual visits to support families over a one-year intervention period . The control group receives enhanced pediatric care plus non-tailored health coaching . MAIN OUTCOME MEASURES Lower age-associated increase in BMI over a 1-year period . The main parent- and child-reported outcome is improved health-related quality of life . CONCLUSIONS The Connect for Health study seeks to support families in leveraging clinical and community re sources to improve obesity-related outcomes that are most important to parents and children BACKGROUND / PURPOSE The prevalence of obesity and overweight among children and adolescents is increasing rapidly . The present research was performed to determine the influence of a ' ' behavior modification ' ' program on body mass index ( BMI ) in obese public high school students in Iran . METHODS In this study , 152 adolescence and their parents were selected from 12 high schools of Khorram Abad from 2004 to 2006 , and they were r and omly assigned to either the intervention or the control groups . The " behavior modification " interventional program consisted of nutritional education , modifying dietary habits , teaching exercise programs , teaching nutritional facts to the parents , and performing exercises 3 days a week . The height and weight as well as waist , hip , and wrist circumferences of the participants were measured before and after implementing the interventional program . BMI and waist to hip ratio ( WHR ) were calculated . The adolescents and parents completed a nutrition knowledge question naire . Adolescents also completed the Beck 's Depression Question naire . RESULTS Adolescent 's mean weight , BMI , and waist and hip circumferences decreased significantly after implementing the interventional program , in the intervention group ( p≤0.001 ) . In addition , the students ' and parents ' nutrition knowledge increased in the intervention group after implementing the interventional program ( p<0.046 ) . The symptoms of depression decreased and the frequency of students without symptoms of depression increased in the case group , but it did not reveal a statistically significant difference between case and control groups . CONCLUSION The ' ' behavior modification ' ' interventional program is effective in reducing BMI in obese students , and therefore , school principals and planners can play an important role in controlling obesity by implementing this program via the students , their parents , and the school staff Introduction This study assessed the short- and long-term effects of a 3-month family-based group treatment in the management of childhood obesity versus individual treatment . Material s and methods Eighty obese children , aged between 6 and 14 years , and their parents were included in this prospect i ve controlled clinical study . Forty participants were r and omly assigned for group treatment and the other 40 for individual treatment . A 3-month intervention program was focused on implementing healthy eating behaviors . The weight and height of the children were measured initially and at each treatment session and at follow-up visits . Body mass index was calculated and expressed as st and ard deviation score . Results and discussion At the end of 3-month treatment program , there was a significant decline in BMI SDS in both groups ( p < 0.001 ) . After 1 year of follow-up period , there was still a significant decrease in BMI SDS in the study group ( p < 0.001 ) , whereas the decrease in BMI SDS was not maintained over the follow-up period in the st and ard group . There was a significantly increased consumption of vegetable and fruit and reduced consumption of carbonated drinks and fruit juice in both groups ( p < 0.001 ) . Conclusion These findings demonstrate that the group treatment is more successful than the individual treatment in the management of childhood obesity Objective : To evaluate the feasibility and efficacy of the ‘ Healthy Dads , Healthy Kids ’ ( HDHK ) program , which was design ed to help overweight fathers lose weight and be a role model of positive health behaviors for their children . Design : R and omized controlled trial . Participants : A total of 53 overweight/obese men ( mean ( s.d . ) age=40.6 ( 7.1 ) years ; body mass index ( BMI ) = 33.2 ( 3.9 ) ) and their primary school-aged children ( n=71 , 54 % boys ; mean ( s.d . ) age=8.2 ( 2.0 ) years ) were r and omly assigned ( family unit ) to either ( i ) the HDHK program ( n=27 fathers , n=39 children ) or ( ii ) a wait-list control group ( n=26 fathers , n=32 children).Intervention : Fathers in the 3-month program attended eight face-to-face education sessions . Children attended three of these sessions . Outcomes : The primary outcome was fathers ’ weight . Fathers and their children were assessed at baseline , and at 3- and 6-month follow-up , for weight , waist circumference , BMI , blood pressure , resting heart rate ( RHR ) , objective ly measured physical activity and self-reported dietary intake . Results : Intention-to-treat analysis revealed significant between-group differences at 6 months for weight loss ( P<0.001 ) , with HDHK fathers losing more weight ( −7.6 kg ; 95 % confidence interval ( CI ) −9.2 , −6.0 ; d=0.54 ) than control group fathers ( 0.0 kg ; 95 % CI −1.4 , 1.6 ) . Significant treatment effects ( P<0.05 ) were also found for waist circumference ( d=0.62 ) , BMI ( d=0.53 ) , systolic blood pressure ( d=0.92 ) , RHR ( d=0.66 ) and physical activity ( d=0.91 ) , but not for dietary intake . In children , significant treatment effects ( P<0.05 ) were found for physical activity ( d=0.74 ) , RHR ( d=0.51 ) and dietary intake ( d=0.84 ) . Conclusion : The HDHK program result ed in significant weight loss and improved health-related outcomes in fathers and improved eating and physical activity among children . Targeting fathers is a novel and efficacious approach to improving health behavior in their children Objective To evaluate a commercially available , structured short‐term weight management program design ed for adolescents with obesity delivered by nonhealth professionals . Study design A multisite parallel‐group r and omized controlled trial was conducted to evaluate a commercial 12‐week lifestyle behavioral program in commercial weight management centers in Australia . Eligible participants ( 13‐17 years , body mass index ( BMI ) z score ≥1.282 with no presenting morbidities ) were r and omized ( n = 88 ) to intervention or wait‐list , and the program was delivered by consultants at participating weight management centers . The primary outcome was change in BMI z score . Secondary outcomes included the psychometric variables quality of life , body‐esteem , and self‐esteem . Data was analyzed according to intention‐to‐treat principles . Results Of 74 participants who consented to enter the study , 66 provided baseline anthropometric data and 12‐week data were available for 55 individuals ( 74 % ) . A significantly greater decrease in BMI z score in the intervention group ( n = 32 ) was observed when compared with the wait‐list control group , mean difference ( MD ) = −0.27 kg/m2 ; 95 % CI , −0.37,−0.17 ; P < .001 ) . Participants allocated to receive the lifestyle intervention reported a greater improvement in body esteem ( MD = 1.7 , 95 % CI , 0.3 , 3.1 ; P = .02 ) and quality of life ( MD = 5.9 , 95 % CI , 0.9 , 10.9 ; P = .02 ) compared with the wait‐list control group . Conclusions A structured lifestyle intervention delivered by a commercial provider in an adolescent population can result in clinical ly relevant weight loss and improvements in psychosocial outcomes in the short term . Further research is required to evaluate long‐term outcomes . Trial registration International Clinical Trials Registry : IS RCT N13602313 OBJECTIVE : To evaluate a healthy lifestyle intervention to reduce adiposity in children aged 5 to 9 years and assess whether adding parenting skills training would enhance this effect . PARTICIPANTS AND METHODS : We conducted a single-blinded r and omized controlled trial of prepubertal moderately obese ( International Obesity Task Force cut points ) children , aged 5 to 9 years . The 6-month program targeted parents as the agents of change for implementing family lifestyle changes . Only parents attended group sessions . We measured BMI and waist z scores and parenting constructs at baseline , 6 , 12 , 18 , 24 months . RESULTS : Participants ( n = 169 ; 56 % girls ) were r and omized to a parenting skills plus healthy lifestyle group ( n = 85 ) or a healthy lifestyle – only group ( n = 84 ) . At final 24-month assessment 52 and 54 children remained in the parenting skills plus healthy lifestyle and the healthy lifestyle – only groups respectively . There were reductions ( P < .001 ) in BMI z score ( 0.26 [ 95 % confidence interval : 0.22–0.30 ] ) and waist z score ( 0.33 [ 95 % confidence interval : 0.26–0.40 ] ) . There was a 10 % reduction in z scores from baseline to 6 months that was maintained to 24 months with no additional intervention . Overall , there was no significant group effect . A similar pattern of initial improvement followed by stability was observed for parenting outcomes and no group effect . CONCLUSIONS : Using approaches that specifically target parent behavior , relative weight loss of ∼10 % is achievable in moderately obese prepubertal children and can be maintained for 2 years from baseline . These results justify an investment in treatment as an effective secondary obesity-prevention strategy BACKGROUND Obesity prevalence is disproportionately high among Hispanic children . OBJECTIVES The Healthy Families Study assessed the efficacy of a culturally targeted , family-based weight gain prevention intervention for Hispanic immigrant families with children ages 5 - 7 years . METHODS The study used a two-group , cluster r and omized trial design , assigning 136 families ( clusters ) to the active intervention ( weight gain prevention ) and 136 families to attention control ( oral health ) . The active intervention included a 4-month intensive phase ( eight classes ) and an 8-month reinforcement phase ( monthly mail/telephone contact ) . Children 's body mass index z-score ( BMI -Z ) was the primary outcome . RESULTS The BMI -Z growth rate of the active intervention group did not differ from the attention control group at short-term follow-up ( median 6 months ; 168 families , 206 children ) or long-term follow-up ( median 16 months ; 142 families , 169 children ) . Dose response analyses indicated a slower increase in BMI -Z at short term among overweight/obese children who attended more intervention classes . Moderate physical activity on weekends increased at short term . Weekend screen time decreased at short term among those attending at least one class session . CONCLUSION Low class attendance likely impacted intention-to-treat results . Future interventions targeting this population should test innovative strategies to maximize intervention engagement to produce and sustain effects on weight gain prevention The Biochemical Evaluation of a Health Intervention Programme ( B.E. H.I.P. ) investigated the impact of progressive exercise intensity in overweight and obese children . A 5-month prospect i ve r and omized crossover design ( X(A ) , immediate intervention ; O(B ) , control group ; X(B ) , delayed intervention , O(A ) , postintervention follow-up ) with a 10-week health intervention programme was employed . The intervention utilized a progressive increase in high-intensity exercise ( ≥ 75 % maximum heart rate ) and included 3 nutrition and 2 parent education sessions . Primary analysis was completed with ( i ) X(A ) versus O(B ) and ( ii ) all intervention participants ( collapsed X(A ) and X(B ) = X(A)X(B ) ) . Prepubertal overweight and obese male and female children ( n = 27 ) between 5 and 10 years of age were r and omly allocated to X(A ) ( n = 16 ; 11 females ; waist circumference = 80.0 ± 10.6 cm ) or O(B ) ( n = 11 ; 3 females ; waist circumference = 76.6 ± 7.5 cm ) . The primary variables were heart rate and percent fat mass . All variables , including body composition , habitual activity , and serum lipids , were repeatedly measured for up to a maximum of 7 time points . Energy expenditure was quantitatively measured throughout each exercise class ( n = 20 ) . A significantly longer time in the exercise sessions was spent in high-intensity ( 35.1%-60.0 % ) versus low- to moderate-intensity ( 64.9%-40.0 % ) exercise as the intervention progressed from the first to the last attended exercise class ( Fisher exact test , p < 0.0001 ) . The percent fat mass decreased in all intervention participants ( -2.2 % , p < 0.0001 ) . X(A ) had a greater slope decrease than O(B ) for percent fat mass ( p = 0.00051 ) and triglycerides ( p = 0.0467 ) . In conclusion , high-intensity exercise , within a comprehensive health programme that includes nutrition education , improved the lipid and physiological health profiles of obese children Purpose To evaluate the effect of multidisciplinary treatment on obesity and health-related quality of life ( HRQOL ) . Methods Obese children were r and omized to a multidisciplinary lifestyle treatment , including medical , nutritional , physical , and psychological counseling during 3 months , ( n = 40 , BMI -SDS ; 4.2 ± 0.7 , age ; 13.3 ± 2.0 ) or st and ard care , including an initial advice on nutrition and physical activity by the pediatrician ( n = 39 , BMI -SDS ; 4.3 ± 0.7 , age ; 13.1 ± 1.9 ) . At baseline , after 3 months of treatment and at 12 months follow-up , data were collected for BMI -SDS and a European vali date d question naire for assessing HRQOL ( DISABKIDS ) . Results A significantly reduced BMI -SDS was found for the intervention group after 3 months treatment ( 4.0 ± 0.9 vs. 4.2 ± 0.7 , P = 0.02 ) and at 12 months follow-up ( 3.8 ± 1.1 vs. 4.2 ± 0.7 , P = 0.03 ) . HRQOL in the intervention group was significantly improved at 12 months follow-up and unchanged in the obese control group . Agreement between child and parent report was moderate ( 67–85 % ) , with parents reporting a lower HRQOL for their obese children than children themselves in both groups . Conclusion Multidisciplinary treatment is effective in reducing BMI -SDS and improving HRQOL after 12 months follow-up Objective : Since peers have such an important influence on adolescents , we evaluated the efficacy of adding peer-based ‘ adventure therapy ’ to a st and ard cognitive-behavioral weight control program for overweight adolescents . Methods : Adolescents ( N=76 ) aged 13–16 years and 20 to 80 % overweight ( M=60.56 % , s.d.=15.17 % ) , were r and omly assigned to one of two treatment conditions : cognitive-behavioral group treatment with ‘ adventure therapy ’ similar to Outward Bound ® ( cognitive-behavioral treatment with peer-enhanced adventure therapy ( CBT+PEAT ) ) or cognitive-behavioral group treatment with aerobic exercise ( CBT+EXER ) . Anthropometric and psychosocial measures were obtained at baseline , at the end of the 16-week intervention , and at 10 months following r and omization . Results : Adolescents assigned to both treatment conditions demonstrated significant weight loss over time , F=29.06 , df=2 , 53 , P<0.01 . Average weight loss did not differ significantly between groups ( −5.31 kg for CBT+PEAT and −3.20 kg for CBT+EXER ) at the end of treatment . There was a significant difference in the percentage of participants maintaining a minimum 4.5 kg ( 10 pounds ) weight loss ( 35 % in the CBT+PEAT condition vs 12 % in the CBT+EXER condition , P=0.042 ) 10 months from r and omization . We also observed a significant age by treatment group interaction , such that older adolescents r and omized to CBT+PEAT demonstrated more than four times the weight loss of older adolescents assigned to CBT+EXER ( M=−7.86 kg vs M=−1.72 kg ) at the end of treatment . Conclusions : Peer-based ‘ adventure therapy ’ is a promising adjunct to st and ard cognitive-behavioral weight control intervention for adolescents , and may be most effective for older adolescents BACKGROUND The current study compares the effectiveness of a condensed 12-week version and a 24-week version of the same pediatric behavioral weight management program . METHODS Children ( n=162 ) between the ages of 8 and 18 years ( baseline BMI z=2.39 ; st and ard deviation=0.29 ) were r and omized to either a 12- or 24-week version of the same behavioral weight management program . Child anthropometric data were recorded at baseline , 6 weeks , 12 weeks , 24 weeks , and 12 months . A two-level longitudinal model was used to examine within- and between-group differences in BMI z change over time . RESULTS A significant group-by-time interaction was found ( β=-0.01 ; st and ard error , < 0.01 ; p<0.01 ) with the 24-week group showing greater reductions in BMI z. Children in the 24-week group showed significant BMI z reductions over time ( z=-5.18 ; p<0.01 ) , but children in the 12-week group did not ( z=-0.85 ; p=0.39 ) . CONCLUSIONS Children in the 24-week program demonstrated greater reductions in BMI z than children in the 12-week group . Therefore , there may be additional benefit to sessions above and beyond the 8- to 12-week minimum suggested for pediatric weight management programs Importance Family-based weight loss treatment ( FBT ) is considered the gold-st and ard treatment for childhood obesity and is provided to the parent and child . However , parent-based treatment ( PBT ) , which is provided to the parent without the child , could be similarly effective and easier to disseminate . Objective To determine whether PBT is similarly effective as FBT on child weight loss over 24 months . Secondary aims evaluated the effect of these 2 treatments on parent weight loss , child and parent dietary intake , child and parent physical activity , parenting style , and parent feeding behaviors . Design , Setting , and Participants R and omized 2-arm noninferiority trial conducted at an academic medical center , University of California , San Diego , between July 2011 and July 2015 . Participants included 150 overweight and obese 8- to 12-year-old children and their parents . Interventions Both PBT and FBT were delivered in 20 one-hour group meetings with 30-minute individualized behavioral coaching sessions over 6 months . Treatments were similar in content ; the only difference was the attendance of the child . Main Outcomes and Measures The primary outcome measure was child weight loss ( body mass index [ BMI ] and BMI z score ) at 6 , 12 , and 18 months post treatment . Secondary outcomes were parent weight loss ( BMI ) , child and parent energy intake , child and parent physical activity ( moderate to vigorous physical activity minutes ) , parenting style , and parent feeding behaviors . Results One hundred fifty children ( mean BMI , 26.4 ; mean BMI z score , 2.0 ; mean age , 10.4 years ; 66.4 % girls ) and their parent ( mean BMI , 31.9 ; mean age , 42.9 years ; 87.3 % women ; and 31 % Hispanic , 49 % non-Hispanic white , and 20 % other race/ethnicity ) were r and omly assigned to either FBT or PBT . Child weight loss after 6 months was −0.25 BMI z scores in both PBT and FBT . Intention-to-treat analysis using mixed linear models showed that PBT was noninferior to FBT on all outcomes at 6- , 12- , and 18-month follow-up with a mean difference in child weight loss of 0.001 ( 95 % CI , −0.06 to 0.06 ) . Conclusions and Relevance Parent-based treatment was as effective on child weight loss and several secondary outcomes ( parent weight loss , parent and child energy intake , and parent and child physical activity ) . Parent-based treatment is a viable model to provide weight loss treatment to children . Trial Registration Clinical trials.gov Identifier : Obesity has become the most common pediatric chronic disease in the modern era . Recent data suggests that unlike obese adults , obese children and adolescents may have decreased bone strength . It was the objective to prospect ively examine the short term effects of a 3 month combined dietary-physical activity intervention on anthropometric measures , body composition , fitness and bone strength in obese children . Twelve obese subjects completed the 3 m intervention and were compared to 12 obese age and gender matched controls . Bone strength was measured using quantitative ultrasound measurements of bone speed of sound ( SOS ) . There were significant differences in changes of body weight ( 0.01 + /- 0.7 vs. 2.3 + /- 0.6 kg , p = 0.033 ) , BMI percentiles ( - 2.8 + /- 1.1 vs. - 0.2 + /- 0.2 % , p = 0.037 ) , body fat percent ( by skinfolds , - 1.5 + /- 0.8 vs. 0.7 + /- 0.5 % , p = 0.035 ) , and endurance time ( 170 + /- 42 vs. 50 + /- 27 s , p = 0.045 ) in the intervention vs. control subjects , respectively . In addition , we found a significant difference in the change of bone SOS between the intervention and control group subjects ( 21.5 + /- 21.6 vs. - 87.0 + /- 37 m/s , p = 0.023 ) . During the critical period of bone development of childhood and adolescence , a combined dietary-physical activity intervention leads to increased bone strength in obese children . These results highlight the importance of multi-disciplinary programs for the treatment of childhood obesity and its complications The primary objective was to develop and test the feasibility and acceptability of the Healthy Home Offerings via the Mealtime Environment ( HOME ) program , a pilot childhood obesity prevention intervention aim ed at increasing the quality of foods in the home and at family meals . Forty-four child/parent dyads participated in a r and omized controlled trial ( n = 22 in intervention and n = 22 in control conditions ) . The intervention program , held at neighborhood facilities , included five , 90-min sessions consisting of interactive nutrition education , taste testing , cooking skill building , parent discussion groups , and h and s-on meal preparation . Children ( 8 - 10-year olds ) and parents ( 89 % mothers ) completed assessment s at their home at baseline , postintervention , and 6-month follow-up , including psychosocial surveys , anthropometry , 24-h dietary recalls , and home food availability and meal offering inventories . Feasibility/acceptability was assessed with participant surveys and process data . All families completed all three home-based assessment s. Most intervention families ( 86 % ) attended at least four of five sessions . Nearly all parents ( 95 % ) and 71 % of children rated all sessions very positively . General linear models indicated that at postintervention , compared to control children , intervention children were significantly more likely to report greater food preparation skill development ( P < 0.001 ) . There were trends suggesting that intervention children had higher consumption of fruits and vegetables ( P < 0.08 ) , and higher intakes of key nutrients ( all P values < 0.05 ) than control children . Obesity changes did not differ by condition . Not all findings were sustained at 6-month follow-up . Obesity prevention programming with families in community setting s is feasible and well accepted . Results demonstrate the potential of the HOME program OBJECTIVE To evaluate whether a child-centered physical activity program , combined with a parent-centered dietary program , was more efficacious than each treatment alone , in preventing unhealthy weight-gain in overweight children . STUDY DESIGN An assessor-blinded r and omized controlled trial involving 165 overweight/obese 5.5- to 9.9- year-old children . Participants were r and omly assigned to 1 of 3 interventions : a parent-centered dietary program ( Diet ) ; a child-centered physical activity program ( Activity ) ; or a combination of both ( Diet+Activity ) . All groups received 10 weekly face-to-face sessions followed by 3 monthly relapse-prevention phone calls . Analysis was by intention-to-treat . The primary outcome was change in body mass index z-score at 6 and 12 months ( n=114 and 106 , respectively ) . RESULTS Body mass index z-scores were reduced at 12-months in all groups , with the Diet ( mean [ 95 % confidence interval ] ) ( -0.39 [ -0.51 to 0.27 ] ) and Diet + Activity ( -0.32 , [ -0.36 , -0.23 ] ) groups showing a greater reduction than the Activity group ( -0.17 [ -0.28 , -0.06 ] ) ( P=.02 ) . Changes in other outcomes ( waist circumference and metabolic profile ) were not statistically significant among groups . CONCLUSION Relative body weight decreased at 6 months and was sustained at 12 months through treatment with a child-centered physical activity program , a parent-centered dietary program , or both . The greatest effect was achieved when a parent-centered dietary component was included OBJECTIVES The primary goals were to underst and the relationship among the inflammatory factors , C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) , and fibrinogen , and indices of obesity in normoglycemic , insulin-resistant adolescents and to investigate the impact of a lifestyle-only intervention on these nontraditional risk factors for cardiovascular disease ( CVD ) . STUDY DESIGN R and omized controlled lifestyle-only intervention study in adolescents . Of the 21 adolescents studied , 15 obese subjects ( body mass index [ BMI ] = 37.6 + /- 3.3 kg/m 2 ) were r and omized to either a lifestyle intervention program or usual care . The lean controls were studied only at baseline . Analysis of variance ( ANOVA ) for repeated measures was used to study intervention effect and t test , one-way ANOVA , and discriminant function analysis for baseline comparisons . RESULTS The intervention group maintained weight , whereas the control group gained weight ( P = .02 ) . A redistribution of body composition and a decrease in insulin resistance were observed . Elevated circulating concentrations of CRP , fibrinogen , and IL-6 were significantly reduced ( all P < or=.02 ) in response to intervention , but not in controls . CONCLUSIONS Modest lifestyle-only change in previously sedentary obese adolescents redistributes the parameters of body composition in the absence of weight loss and reverses , at least in part , the inflammatory state in association with an improvement of insulin resistance OBJECTIVES The purpose of this study was to evaluate the effects of multicomponent school based intervention constituted of diet modification , regular exercise and psychosocial consultation on body status in overweight and obese children and adolescents . And to come up with an appropriate intervention protocol for controlling children and adolescents obesity in Shantou city . METHODS Two schools were r and omised to intervention group and control group respectively . A total of 41 students enrolled were diagnosed as overweight or obese . Twenty-six students of the intervention group completed the one-year intervention programme consisted of diet modification , regular exercise and psychological consultation except two of them were transferred to another school . The differences of BMI , anthropometric measures , metabolic profile and the scores of question naire and the scale were compared to evaluate the effects of the intervention programme . RESULTS After one-year intervention , it observed in the intervention group that BMI -Z score , WHR and WHtR had significant improvements , and there was a nonsignificant trend ( P=0.053 ) for a decrease in BMI -P. Fasting plasma glucose , cholesterol ( CH ) and low-density-lipoprotein cholesterol ( LDL-C ) levels in the intervention group showed nonsignificant trend for a decrease ( PFPG=0.084 , PCH=0.057 , PLDLC=0.098 ) , compared with a significant increase of triglycerides ( TG ) and LDL-C levels in the control group ( PTG=0.041 , PLDL-C=0.038 ) . There were some positive dietary , physical activity , or sedentary behaviour changes found in the students of the intervention group as the scores of the question naire got significant improvement ( P=0.04 ) . CONCLUSIONS Our one-year multicomponent school-based intervention programme did have positive effects to some extents on health state and lifestyle behaviour of overweight and obese children and adolescents , which indicated that it is feasible and important to implement such a school-based intervention programme in Shantou city Pediatric overweight is associated with numerous physical and psychological health risks , and overweight children are at significant risk for obesity in adulthood . African-American children are at particularly high risk for obesity and related health complications . However , this racial group has traditionally had limited access to obesity treatment and relatively few studies have included sufficient numbers of lower-SES , African American participants . Further , although parental involvement in treatment for pediatric overweight has been found to be beneficial , few studies have examined the efficacy of offering treatment exclusively to parents , a potentially cost-effective approach which could benefit the entire family . This pilot project will evaluate the efficacy of an intensive parenting intervention , ( NOURISH ; Nourishing Our Underst and ing of Role modeling to Improve Support and Health ) , targeting racially diverse parents of overweight children ( ages 6 - 11 ) . NOURISH addresses several urgent research priorities by targeting the underserved and addressing the significant disparity in obesity treatment services . Parents meeting study criteria ( having a child between the ages of 6 and 11 with a BMI ≥ the 85th percentile ) will be offered participation in the r and omized trial comparing NOURISH with a control group . We hypothesize that children whose parents participate in NOURISH will manifest greater decreases in BMI , and greater improvements in dietary intake , and quality of life compared to children whose parents do not participate . This study is design ed explicitly to gather preliminary feasibility , acceptability , and effectiveness data to inform a subsequent larger r and omized controlled trial OBJECTIVE To assess the impact of a 2-year recreational physical activity program in 1044 fourth- and fifth- grade primary schoolchildren from the Province of Cuenca , Spain . STUDY DESIGN Cluster-r and omized controlled trial with 10 intervention and 10 control schools . The program consisted of 3 90-minute sessions of physical activity per week , during 28 weeks every year . Changes in endpoints between baseline ( September 2004 ) and the end of follow-up ( June 2006 ) were compared between the control and intervention group by using mixed regression models , with adjustment for the baseline endpoint value , age , and the school . RESULTS Compared with control subjects , intervention girls reduced the frequency of overweight ( odds ratio , 0.55 ; 95 % CI , 0.39 - 0.78 ; P<.001 ) . However , intervention was associated with an increase in the percentage of body fat in boys ( 0.97 % ; 95 % CI , 0.14 - 1.81 ; P=.02 ) . Girls in the intervention group had lower total cholesterol level ( -6.86 mg/dL ; 95 % CI , -9.70 - -4.01 ; P<.001 ) and apolipoprotein B level ( -3.61 mg/dL ; 95 % CI , -6.27 - -0.95 ; P=.008 ) than control subjects . Results were similar in boys . CONCLUSION In 2 years , the physical activity program lowered the frequency of overweight in girls and reduced total cholesterol and apolipoprotein B in both girls and boys Background : Traditional obesity prevention programs are time- and cost-intensive . Mobile phone technology has been successful in changing behaviors and managing weight ; however , to our knowledge , its potential in young children has yet to be examined . Objective : We assessed the effectiveness of a mobile health ( mHealth ) obesity prevention program on body fat , dietary habits , and physical activity in healthy Swedish children aged 4.5 y. Design : From 2014 to 2015 , 315 children were r and omly assigned to an intervention or control group . Parents in the intervention group received a 6-mo mHealth program . The primary outcome was fat mass index ( FMI ) , whereas the secondary outcomes were intakes of fruits , vegetables , c and y , and sweetened beverages and time spent sedentary and in moderate-to-vigorous physical activity . Composite scores for the primary and secondary outcomes were computed . Results : No statistically significant intervention effect was observed for FMI between the intervention and control group ( mean ± SD : -0.23 ± 0.56 compared with -0.20 ± 0.49 kg/m2 ) . However , the intervention group increased their mean composite score from baseline to follow-up , whereas the control group did not ( + 0.36 ± 1.47 compared with -0.06 ± 1.33 units ; P = 0.021 ) . This improvement was more pronounced among the children with an FMI above the median ( 4.11 kg/m2 ) ( P = 0.019 ) . The odds of increasing the composite score for the 6 dietary and physical activity behaviors were 99 % higher for the intervention group than the control group ( P = 0.008 ) . Conclusions : This mHealth obesity prevention study in preschool-aged children found no difference between the intervention and control group for FMI . However , the intervention group showed a considerably higher postintervention composite score ( a secondary outcome ) than the control group , especially in children with a higher FMI . Further studies targeting specific obesity classes within preschool-aged children are warranted . This trial was registered at clinical trials.gov as NCT02021786 Parent-only ( PO ) treatments for childhood obesity are feasible , more cost-effective and potentially easier to disseminate . The objective of this study was to determine whether a PO treatment is not inferior to a parent + child ( PC ) treatment for childhood obesity . Eighty parent-child dyads with an 8 - 12 year old overweight or obese child ( > 85th BMI -P ) were recruited and r and omized into PO or PC treatment for childhood obesity . Parents or parent-child dyads attended 5-month treatment groups . Child and parent body size , child caloric intake , and child physical activity were assessed at baseline , post-treatment , and 6-months follow-up . Noninferiority testing using mixed linear models was used to compare PO treatment with PC treatment . Results showed that the PO group was not inferior to the PC group in terms of child weight loss . Results also showed that the PO group was not inferior to the PC group in terms of parent weight loss and child physical activity , but not child caloric intake . This study suggests that a PO treatment could provide similar results to PC in child weight loss and other relevant outcomes , and potentially could be more cost-effective and easier to disseminate . Although further research is needed , this study suggests that PO groups are a viable method for providing childhood obesity treatment Objectives : To reduce gain in body mass index ( BMI ) in overweight/mildly obese children in the primary care setting . Design : R and omized controlled trial ( RCT ) nested within a baseline cross-sectional BMI survey . Setting : Twenty nine general practice s , Melbourne , Australia . Participants : ( 1 ) BMI survey : 2112 children visiting their general practitioner ( GP ) April – December 2002 ; ( 2 ) RCT : individually r and omized overweight/mildly obese ( BMI z-score < 3.0 ) children aged 5 years 0 months–9 years 11 months ( 82 intervention , 81 control).Intervention : Four st and ard GP consultations over 12 weeks , targeting change in nutrition , physical activity and sedentary behaviour , supported by purpose - design ed family material s . Main outcome measures : Primary : BMI at 9 and 15 months post-r and omization . Secondary : Parent-reported child nutrition , physical activity and health status ; child-reported health status , body satisfaction and appearance/self-worth . Results : Attrition was 10 % . The adjusted mean difference ( intervention – control ) in BMI was −0.2 kg/m2 ( 95 % CI : −0.6 to 0.1 ; P=0.25 ) at 9 months and −0.0 kg/m2 ( 95 % CI : −0.5 to 0.5 ; P=1.00 ) at 15 months . There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months . There was weak evidence of an increase in daily physical activity in the intervention arm . Health status and body image were similar in the trial arms . Conclusions : This intervention did not result in a sustained BMI reduction , despite the improvement in parent-reported nutrition . Brief individualized solution-focused approaches may not be an effective approach to childhood overweight . Alternatively , this intervention may not have been intensive enough or the GP training may have been insufficient ; however , increasing either would have significant cost and re source implication s at a population level OBJECTIVE The Girls health Enrichment Multisite Studies ( GEMS ) Fun , Food , and Fitness Project ( FFFP ) was design ed to prevent obesity among 8-year-old African-American girls . DESIGN Twelve-week , two-arm parallel group r and omized controlled pilot study . SETTING Summer day camp and homes in Houston , Texas . PARTICIPANTS Thirty-five girls and their parents or caregivers were r and omly assigned to treatment ( N=19 ) or control groups ( N=16 ) . INTERVENTION Girls in the intervention group attended a special 4-week summer day camp , followed by a special 8-week home Internet intervention for the girls and their parents . Control group girls attended a different 4-week summer day camp , followed by a monthly home Internet intervention , neither of which components included the GEMS-FFFP enhancements . MAIN OUTCOME MEASURES Body mass index ( BMI ) , consumption of fruit , 100 % fruit juice , and vegetables ( FJV ) , physical activity . RESULTS After adjusting for baseline BMI , there were no significant differences in BMI between treatment and control group girls , either at the end of the 4-week summer day camp , or after the full 12-week intervention . By the end of the summer camp , the subgroup of treatment group girls heavier at baseline exhibited a trend ( P<.08 ) toward lower BMI , compared to their heavier counterparts in the control group . Overall results at the end of the 12-week program demonstrated substantial , although not significant , differences between treatment and control groups in the hypothesized directions . On average , less than half the treatment sample logged onto the Website , which limited intervention dose . CONCLUSIONS Summer day camp appears to offer promise for initiating health behavior change . Effective methods must be developed and tested to enhance log-on rates among healthy children and their parents before Internet programs can achieve their potential BACKGROUND Parental obesity reduces the likelihood of a multidisciplinary childhood obesity program to succeed , suggesting that special family-based interventions should be constructed for obese children from obese families . AIM To examine the effects of an intense combined 3-month familial dietary-behavioral-physical activity intervention for a subgroup of obese children ( BMI > 95th percentile ) from obese families ( parental BMI > 27 kg/m2 ) compared to a control group of obese children and obese parents who did not participate in the combined intervention . CHILDREN Twenty-two obese children were r and omly assigned to the intervention ( n = 11 ) or control ( n = 11 ) group . Anthropometric measurements , body composition , dietary and activity habits and fitness levels were measured before and at the end of a 3-month intervention . RESULTS The intervention led to a significant difference in change in body weight ( -0.2 + /- 0.3 vs 1.7 + /- 0.6 kg ; p < 0.05 ) , BMI percentiles ( -1.4 + /- 0.5 vs -0.1 + /- 0.2 % ; p < 0.05 ) , and to a decrease in screen ( television and computer ) time ( -2.2 + /- 0.6 vs 0.1 + /- 0.3 h/day ; p < 0.05 ) in the intervention group compared to the controls . In addition , the intervention led to a significant improvement in fitness level determined by endurance time ( 181 + /- 30 vs 26 + /- 63 seconds in the intervention vs control group , respectively ; p < 0.05 ) . CONCLUSION Obese children from obese families pose a therapeutic challenge to health care providers . Intense family-oriented multidisciplinary weight management intervention should be design ed for treatment in this unique population The purpose of this study was to pilot test the Comics for Health program , a theory-based nutrition and physical activity intervention for children . Twelve after-school programs were r and omized to either a theory-based ( n = 37 ) or a knowledge-based ( n = 34 children ) version of the intervention . Pretests , posttests , and 3-month follow-up tests were administered to evaluate the programmatic effects on body mass index percentile , obesity-related behaviors , and constructs of social cognitive theory . Both interventions found significant , yet modest effects for fruit and vegetable consumption ( P < .005 ) , physical activities ( P < .004 ) , and water and sugar-free beverage consumption ( P < .001 ) and self-efficacy for fruit and vegetable consumption ( P < .015 ) and physical activities ( P < .009 ) OBJECTIVE To examine the effectiveness of a family-based behavioral group intervention ( Positively Fit ; PF ) for pediatric obesity relative to a brief family intervention ( BFI ) in a sample of treatment-seeking children and adolescents . METHODS Families ( n = 93 ) were r and omized to treatment condition . Assessment s were conducted at pre- and posttreatment and at 12-month follow-up . Outcome indices included st and ardized body mass index ( BMI ) and quality of life ( QOL ) . RESULTS Results indicated a significant reduction in z BMI at posttreatment and follow-up across both conditions . At follow-up , BFI and PF participants evidence d average reductions of .12 and .19 z BMI units , respectively . Children demonstrated better outcomes than adolescents across both conditions . Results indicated clinical ly significant improvements in parent-reported QOL at postintervention and in self-reported QOL at follow-up for PF participants . CONCLUSIONS Results suggest the effectiveness of family-based interventions for pediatric obesity in clinical setting s among younger children . Neither intervention was effective in terms of reducing z BMI among adolescents PURPOSE To compare the costs of parent-only and family-based group interventions for childhood obesity delivered through Cooperative Extension Services in rural communities . METHODS Ninety-three overweight or obese children ( aged 8 to 14 years ) and their parent(s ) participated in this r and omized controlled trial , which included a 4-month intervention and 6-month follow-up . Families were r and omized to either a behavioral family-based intervention ( n = 33 ) , a behavioral parent-only intervention ( n = 34 ) , or a waitlist control condition ( n = 26 ) . Only program costs data for the parent-only and family-based programs are reported here ( n = 67 ) . Assessment s were completed at baseline , post-treatment ( month 4 ) and follow-up ( month 10 ) . The primary outcome measures were total program costs and cost per child for the parent-only and family interventions . FINDINGS Twenty-six families in the parent-only intervention and 24 families in the family intervention completed all 3 assessment s. As reported previously , both intervention programs led to significantly greater decreases in weight status relative to the control condition at month 10 follow-up . There was no significant difference in weight status change between the parent-only and family interventions . Total program costs for the parent-only and family interventions were 13,546 US dollars and 20,928 , US dollars respectively . Total cost per child for the parent-only and family interventions were 521 US dollars and 872 US dollars , respectively . CONCLUSIONS Parent-only interventions may be a cost-effective alternative treatment for pediatric obesity , especially for families in medically underserved setting The purpose of the present study was to evaluate an intervention to prevent weight gain among households ( HHs ) in the community . Ninety HHs were r and omized to intervention or control group for 1 year . Intervention consisted of six face-to-face group sessions , placement of a television ( TV ) locking device on all home TVs , and home-based intervention activities . Measures were collected in person at baseline and 1 year . Weight , height , eating behaviors , physical activity ( PA ) , and TV viewing were measured among HH members ages ≥ 12 years . Follow-up rate at 1 year was 96 % . No significant intervention effects were observed for change in HH BMI -z score . Intervention HHs significantly reduced TV viewing , snacks/sweets intake , and dollars per person spent eating out , and increased ( adults only ) PA and self-weighing frequency compared with control HHs . A 1 year obesity prevention intervention targeting entire HHs was effective in reducing TV viewing , snack/sweets intake and eating out purchases . Innovative methods are needed to strengthen the home food environment intervention component . Longer intervention duration s also need to be evaluated OBJECTIVE Better adherence to treatment strategies in family-based behavioral weight control programs may lead to greater weight reduction and improved weight maintenance in youth . This study assessed the influence of child and parent self-reported adherence to behavioral strategies on changes in 2-year child and parent percentage overweight . RESEARCH METHODS AND PROCEDURES Participants included 8- to 12-year-old children in > or= 85th BMI percentile and their parents from 110 families taking part in two family-based r and omized controlled weight control studies . This study examined whether self-reported adherence to behavioral strategies measured at 24 months increased prediction of child and parent percentage overweight change through 24-month follow-up after accounting for other factors that may influence weight change . RESULTS Child adherence to weighing and to preplanning for celebrations where high-fat foods are served and parent adherence to praising the child and modeling healthy eating habits predicted 24-month child percentage overweight change ( p<0.001 ) . Child adherence to recording food and calories and parent adherence to modeling healthy eating habits predicted 24-month parent percentage overweight change ( p<0.001 ) . In hierarchical regression models , child weighing and preplanning and parent modeling were significant ( p<0.01 ) incremental predictors ( r2 of 24.8 % ) of 24-month child percentage overweight . Child recording and parent modeling were significant ( p<0.01 ) incremental predictors ( r2 of 14 % ) of parent 24-month percentage overweight change . DISCUSSION Child and parent adherence to specific components of family-based behavioral weight control treatment are independent predictors of long-term child and parent percentage overweight change OBJECTIVES Single sex after-school physical activity programs show potential to prevent unhealthy weight gain . The aim of this study was to assess the acceptability and potential efficacy of single-sex after-school physical activity programs for overweight and at-risk children from low-income communities . DESIGN 7-month , 2-arm parallel-group , RCT , conducted at an elementary school in a disadvantaged area in Wollongong , Australia ( March-November 2010 ) . METHODS 20 boys and 17 girls were r and omized to intervention ( PA ) or active comparison groups ( HL ) . Primary outcomes included implementation , acceptability , percentage body fat and BMI z-score . RESULTS The PA programs were acceptable with high implementation and enjoyment rates . At 7 months postintervention girls in the PA group displayed greater changes in percentage body fat ( adjust diff . = -1.70 , [ 95 % CI -3.25 , -0.14 ] ; d = -0.83 ) and BMI z-score ( -0.19 [ -0.36 , -0.03 ] ; d= -1.00 ) . At 7 months boys in the PA group showed greater changes in waist circumference ( -3.87 cm [ -7.80 , 0.15 ] ; d= -0.90 ) and waist circumference z-score ( -0.33 [ -0.64 , -0.03 ] ; d= -0.98 ) . For both boys ' and girls ' PA groups , changes in adiposity were not maintained at 12-month follow-up . CONCLUSIONS Single-sex after-school physical activity programs are acceptable and potentially efficacious in preventing unhealthy weight gain among overweight and at-risk children . However improvements are hard to sustain once programs finish operating INTRODUCTION Reducing Latino preschoolers ' TV viewing is needed to reduce their risk of obesity and other chronic diseases . This study 's objective was to evaluate the Fit 5 Kids ( F5 K ) TV reduction program 's impact on Latino preschooler 's TV viewing . STUDY DESIGN Cluster RCT with r and omization at the center level and N=160 participants . SETTING / PARTICIPANTS Latino children aged 3 - 5 years and their parents were recruited from six Head Start centers in Houston TX in 2010 - 2012 with analyses in 2013 - 2014 . INTERVENTION F5 K was culturally adapted for Latino preschoolers and the overall goal was to reduce TV viewing . Study staff taught F5 K over 7 - 8 weeks during the regular Head Start day directly to intervention students . Control schools provided the usual Head Start curriculum , which did not specifically cover TV viewing . MAIN OUTCOME MEASURES Individual-level outcomes were measured prior to ( Time 1 ) and immediately following ( Time 2 ) the intervention . The primary outcome , TV viewing ( minutes/day ) , was measured by vali date d 7-day TV diaries ( parent-reported ) . Sedentary time was measured by accelerometers . RESULTS Per the adjusted repeated measures linear mixed effects model for TV viewing ( minutes/day ) , intervention children decreased from 76.2 ( 9.9 ) at Time 1 to 52.1 ( 10.0 ) at Time 2 , whereas control children remained about the same from 84.2 ( 10.5 ) at Time 1 to 85.4 ( 10.5 ) at Time 2 . The relative difference from Time 1 to Time 2 was -25.3 ( 95 % CI= -45.2 , -5.4 ) minutes for intervention versus control children ( N=160 , p=0.01 ) . In a similar adjusted model , there was a relative decrease in sedentary time ( minutes/day ) from Time 1 to Time 2 favoring the intervention children ( -9.5 , 95 % CI= -23.0 , 4.1 ) , although not significant at p<0.05 . CONCLUSIONS F5 K reduced Latino preschoolers ' TV viewing by > 25 minutes daily . These findings have implication s for prevention of obesity , related disorders , and health equity . TRIAL REGISTRATION This study is registered at www . clinical trials.gov NCT01216306 This study examined change in binge eating symptoms reported by moderately overweight adolescents following participation in a behavioral weight control intervention . A total of 194 adolescents across two r and omized controlled trials participated . Adolescents in both study sample s endorsed a mild level of binge eating symptoms at baseline . Results from both Study 1 and Study 2 indicate a significant reduction in binge eating symptoms following participation in a 16-week weight control intervention , F(1,60 ) = 9.43 , p<.01 and F(1,98 ) = 20.98 , p<.01 , respectively . Several significant relationships between measures of self-concept and binge eating symptoms were noted , with lower self-concept scores related to higher binge eating symptoms scores at baseline . Changes in binge eating symptoms were also related to changes in physical appearance self-concept , global self-concept and physical self-worth at the end of the intervention . In conclusion , findings from this study support an emerging body of evidence suggesting that dietary restriction , as practice d through participation in a weight control intervention , leads to a reduction in binge eating symptoms among overweight adolescents Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists BACKGROUND The effectiveness of once per week ( OPW ) delivery of a family-based childhood obesity programme was compared with twice per week ( TPW ) delivery in achieving health and behavioural outcomes at a population level and in improving programme attendance . Both programmes were delivered over 10-weeks , and the contact hours in the OPW and TPW programmes were 20 and 35-h , respectively . METHODS A cluster-r and omised controlled trial with stratification by local health district was conducted . Height , weight and global self esteem of participants and parent-reported diet and physical activity were measured at programme commencement and completion and at 6-month follow-up . Attendance was defined as the proportion of total sessions attended . RESULTS There were no differences between the OPW and TPW arms in changes from pre-programme baseline for body mass index ( BMI ) z-score and other health and behaviourial measures at programme completion and at follow-up , except for the increase in physical activity outside of the programme at programme completion ( OPW , 3.5 h/week ; TPW , 1.9 h/week ; p = 0.03 ) . OPW and TPW participants attended 71.2 % and 69.2 % of the total sessions , respectively . Attendance was the only contributing factor to a positive BMI z-score outcome ( β = -2.45 , p < 0.01 ) with no effects of child age and gender , language spoken at home or highest qualification of mother . CONCLUSIONS A family-based childhood obesity programme can be delivered OPW with no compromise to health or behavioural outcomes compared with TPW . Higher attendance , as a proportion of available sessions , leads to better outcomes for children This study examined the feasibility of implementing an innovative theater-based after-school program , ' Ready . Set . ACTION ! ' , to reach ethnically diverse and low-income children and their parents with obesity prevention messages . The study population included 96 children and 61 parents . Children were in fourth to sixth grade and 41 % were overweight at baseline . Program impact was evaluated with a pre/post-r and omized controlled study design , but a major focus was placed on the process evaluation conducted in the intervention schools . Intervention children and parents reported high program satisfaction and that they had made changes or intended to make positive changes in their behaviors due to program participation . However , few meaningful differences between the intervention and control conditions were found at follow-up . Thus , the combined process and impact evaluation results suggest that the intervention was effective in leading to increased awareness of the need for behavioral change , but was not powerful enough on its own to lead to behavioral change . From this feasibility study , we concluded that Ready . Set . ACTION ! offers promise as a creative intervention strategy . The next research step may be to incorporate theater-based programs into more comprehensive school-based interventions , with both educational and environmental components , and evaluate program impact Background : Childhood obesity has become a nutritional problem in China since the 1990s . Aims : A family based behavioural treatment was developed and tested , to see if its use was feasible in China and to evaluate its impact on obese schoolchildren . Methods : In a single school in Beijing , 33 obese children were r and omly assigned to a treatment group and 35 to a control group . The treatment group participated in a family based behavioural treatment programme for two years . Height and weight were measured every six months for all participants . Blood pressure , cholesterol , and triglyceride levels were measured at baseline and after two years of programme implementation . Results : Body mass index ( BMI , kg/m2 ) was significantly reduced in the treatment group ( from 26.6 ( 1.7 ) to 24.0 ( 0.9 ) , 95 % CI 2.06 to 3.18 ) but not in the control group ( from 26.1 ( 1.5 ) to 26.0 ( 1.6 ) ) . Total cholesterol decreased 5.5 % and triglycerides 9.7 % in the treatment group . There was a significant correlation between change in BMI and change in triglycerides . There were no significant changes in plasma lipids in the controls . Blood pressure values also decreased significantly in the treatment , but not the control group . Conclusions : A family based behavioural intervention was feasible to use in treating obesity in schoolchildren in Beijing , China . After two years of implementation , it successfully decreased the degree of obesity , reduced levels of blood pressure , and decreased serum lipids in treatment ; there were no significant changes among control children BACKGROUND The primary care setting offers the opportunity to reach children and parents to encourage healthy lifestyle behaviours , and improve weight status among children . OBJECTIVE Test the feasibility of Helping H AND ( Healthy Activity and Nutrition Directions ) , an obesity intervention for 5- to 8-year-old children in primary care clinics . METHODS A r and omized controlled pilot study of Helping H AND , a 6-month intervention , targeted children with body mass index 85 - 99%tile and their parents . Intervention group attended monthly sessions and self-selected child behaviours and parenting practice s to change . Control group received regular paediatric care and was wait-listed for Helping H AND . Session completion , participant satisfaction , child anthropometrics , dietary intake , physical activity , TV viewing and behaviour-specific parenting practice s were measured pre and post intervention . RESULTS Forty parent-child dyads enrolled : 82.5 % were Hispanic , 80 % had a girl and 65 % reported income ≤ $ 30 , 000/year . There was 20 % attrition from Helping H AND ( attended < 4/6 sessions ) . Families self-selected 4.35 ( SD 1.75 ) behaviours to target during the 6-month programme and each of the seven behaviours was selected by 45 - 80 % of the families . There were no between group differences in the child 's body mass index z-score , dietary intake or physical activity post intervention . Intervention group viewed 14.9 ( SE 2.3 ) h/week of TV post intervention versus control group 23.3 ( SE 2.4 ) h/week ( P < 0.05 ) . CONCLUSION Helping H AND is feasible , due to low attrition , good programme attendance , and clinical ly relevant improvements in some child and parenting behaviours INTRODUCTION Family- and school-based interventions for childhood obesity have been widely applied ; however , the prevalence of childhood obesity remains high . The purpose of this RCT is to evaluate the effectiveness of a family-individual-school-based comprehensive intervention model . DESIGN Cluster RCT . SETTING / PARTICIPANTS Fourteen primary schools were selected from 26 primary schools in a district of Shanghai , China , and then r and omly divided into intervention and control groups with seven schools in each . The trial started with first- grade students . A total of 1,287 students in the intervention group and 1,159 in the control group were studied overall . INTERVENTION The baseline study was conducted in January 2011 , and family-individual-school-based interventions started in March 2011 and ended in December 2013 for intervention group students . Three follow-up studies were conducted in January 2012 , January 2013 , and January 2014 . Data analysis was conducted in March 2014 . MAIN OUTCOME MEASURES Students ' weight and height were measured . The prevalence of obesity/overweight and BMI z-scores were calculated and analyzed using a generalized estimating equation approach . RESULTS The overall prevalence of overweight/obesity declined from 28.92 % in 2011 to 24.77 % in 2014 , with a difference of 4.15 % in the intervention group compared with a 0.03 % decline ( from 30.71 % to 30.68 % ) in the control group . The intervention group had significantly lower odds of developing obesity or overweight and had decreased average BMI z-scores compared with the control group , especially for obese or overweight students . CONCLUSIONS The family-individual-school-based comprehensive intervention model is effective for controlling childhood obesity and overweight Objective To compare the effectiveness of a 2-year camp-based family treatment programme and an outpatient programme on obesity in two generations . Design Pragmatic r and omised controlled trial . Setting Rehabilitation clinic , tertiary care hospital and primary care . Patients Families with at least one child ( 7–12 years ) and one parent with obesity . Interventions Summer camp for 2 weeks and 4 repetition weekends or lifestyle school including 4 days family education . Behavioural techniques motivating participants to healthier lifestyle . Main outcome measures Children : 2-year changes in body mass index ( BMI ) SD score ( SDS ) . Parents : 2-year change in BMI . Main analyses : linear mixed models . Results Ninety children ( 50 % girls ) were included . Baseline mean ( SD ) age was 9.7 ( 1.2 ) years , BMI 28.7 ( 3.9 ) kg/m2 and BMI SDS 3.46 ( 0.75 ) . The summer-camp children had a lower adjusted estimated mean ( 95 % CI ) increase in BMI ( −0.8 ( −3.5 to −0.2 ) kg/m2 ) , but the BMI SDS reductions did not differ significantly ( −0.11 ( −0.49 to 0.05 ) ) . The 2-year baseline adjusted BMI and BMI SDS did not differ significantly between summer-camp and lifestyle-school completers , BMI 29.8 ( 29.1 to 30.6 ) vs 30.7 ( 29.8 to 31.6 ) kg/m2 and BMI SDS 2.96 ( 2.85 to 3.08 ) vs 3.11 ( 2.97 to 3.24 ) , respectively . The summer-camp parents had a small reduction in BMI ( −0.9 ( −1.8 to −0.03 ) vs −0.8 ( −2.1 to 0.4 ) in the lifestyle-school group ) , but the within-group changes did not differ significantly ( 0.3 ( −1.7 to 2.2 ) ) . Conclusions A 2-year family camp-based obesity treatment programme had no significant effect on BMI SDS in children with severe obesity compared with an outpatient family-based treatment programme . Trial registration number NCT01110096 OBJECTIVE This paper describes the development of an after-school obesity-prevention program for African-American girls , and presents findings from a 12-week pilot trial conducted by the University of Minnesota . This study was part of the GEMS project , created to test interventions design ed to reduce excess weight gain in African-American girls . DESIGN Two-arm parallel group , r and omized controlled trial . Measures were taken at baseline and at 12 weeks follow up . SETTING An after-school community program . PARTICIPANTS Fifty-four African-American girls , 8- to 10-years of age , and their parents/caregivers . INTERVENTION The after-school intervention was conducted twice a week for 12 weeks , and focused on increasing physical activity and healthy eating . A family component was also included . Girls in the control group received a program over 12 weeks unrelated to nutrition and physical activity . OUTCOMES Measures included height and weight ( body mass index ) , percent body fat ( DEXA ) , physical activity , assessed using a CSA accelerometer and self-report , two 24-hour dietary recalls , and psycho-social and demographic variables . Parental data included demographic and psycho-social characteristics , and dietary measures . Additionally , process evaluation data on the intervention were collected . RESULTS Recruitment goals were met . After adjustment for baseline level , follow-up BMI did not differ between the treatment groups , an expected finding , given that this was a pilot study . At 12 weeks follow up , differences between the intervention and control groups were in the hypothesized direction of change for most variables , among both the girls and their parents . Process evaluation results demonstrated that the program was well attended , and well received , by girls and parents . CONCLUSIONS An after-school obesity prevention program for low-income African-American girls is a promising model for future efforts Motivational interviewing ( MI ) shows promise for pediatric obesity prevention , but few studies address parental perceptions of MI . The aim of this study was to identify correlates of parental perceptions of helpfulness of and satisfaction with a MI-based pediatric obesity prevention intervention . We studied 253 children 2 to 6 years of age in the intervention arm of High Five for Kids , a primary care – based r and omized controlled trial . In multivariable models , parents born outside the United States ( odds ratio [ OR ] = 8.81 ; 95 % confidence interval [ CI ] = 2.44 , 31.8 ) , with lower household income ( OR = 3.60 ; 95 % CI = 1.03 , 12.55 ) , and with higher BMI ( OR = 2.86 ; 95 % CI = 1.07 , 7.65 ) were more likely to perceive MI-based visits as helpful in improving children ’s obesity-related behaviors after the first year of the intervention . Parents of female ( vs male ) , black ( vs white ) , and Latino ( vs white ) children had lower intervention satisfaction . Our findings underscore the importance of tailoring pediatric obesity prevention efforts to target population OBJECTIVE To assess the effects of reducing television viewing and computer use on children 's body mass index ( BMI ) as a risk factor for the development of overweight in young children . DESIGN R and omized controlled clinical trial . SETTING University children 's hospital . PARTICIPANTS Seventy children aged 4 to 7 years whose BMI was at or above the 75th BMI percentile for age and sex . INTERVENTIONS Children were r and omized to an intervention to reduce their television viewing and computer use by 50 % vs a monitoring control group that did not reduce television viewing or computer use . MAIN OUTCOME MEASURES Age- and sex-st and ardized BMI ( z BMI ) , television viewing , energy intake , and physical activity were monitored every 6 months during 2 years . RESULTS Children r and omized to the intervention group showed greater reductions in targeted sedentary behavior ( P < .001 ) , z BMI ( P < .05 ) , and energy intake ( P < .05 ) compared with the monitoring control group . Socioeconomic status moderated z BMI change ( P = .01 ) , with the experimental intervention working better among families of low socioeconomic status . Changes in targeted sedentary behavior mediated changes in z BMI ( P < .05 ) . The change in television viewing was related to the change in energy intake ( P < .001 ) but not to the change in physical activity ( P = .37 ) . CONCLUSIONS Reducing television viewing and computer use may have an important role in preventing obesity and in lowering BMI in young children , and these changes may be related more to changes in energy intake than to changes in physical activity OBJECTIVE To conduct a pilot study design ed to measure the impact of a healthy lifestyle intervention with or without individualized mentorship on adiposity , metabolic profile , nutrition and physical activity in overweight teens . METHODS A total of 38 overweight adolescents ( body mass index above the 85th percentile ) 12 to 16 years of age , who were enrolled in a healthy lifestyle intervention program for six months , were r and omly assigned to a nonmentored or individualized mentored intervention . RESULTS For the entire cohort ( final n=32 ) , there was a nonstatistically significant reduction in mean ( ± SD ) body mass index z score ( 2.08±0.38 to 2.01±0.47 , P=0.07 ) and waist circumference ( 98±10 cm to 96±11 cm , P=0.08 ) , and significant improvements in high-density lipoprotein level ( 1.08±0.24 mmol/L to 1.20±0.26 mmol/L , P<0.001 ) , and low-density lipoprotein/high-density lipoprotein ratio ( 2.55±0.84 to 2.26±0.87 , P<0.001 ) from baseline to the end of the intervention . Subjects consumed fewer high-calorie foods ( 3.9±1.9 to 3.0±1.5 servings/day , P=0.01 ) and snacks ( 9.7±5.5 to 6.8±4.0 servings/day , P=0.02 ) , made fewer fast food restaurant visits ( 1.4±1.3 to 0.8±0.9 visits/week , P=0.02 ) , and had less screen time ( 8.3±3.8 to 6.9±3.6 h/day , P=0.01 ) . In addition , mentorship was found to be a feasible approach to supporting weight management in obese teens . Our study was underpowered to determine treatment effect , but promising modifications to lifestyle were observed despite the absence of statistically significant improvements in outcomes . CONCLUSIONS The healthy lifestyle intervention improved subjects ' lifestyles and lipid profiles , and the addition of mentorship in this context is feasible . A larger study with a longer intervention time is required to determine whether behavioural changes are associated with clinical improvement and to determine the role of mentorship in promoting lifestyle change Recent findings indicate that nearly 50 % of black American women are obese and that adolescence is a critical period for the development of their obesity . This study investigated the efficacy of a behavioral weight control program in 36 black female adolescents with a mean age of 14.0 years , weight of 95.0 kg , and height of 163.2 cm . All subjects participated in the same 16-week program but had different levels of parent participation : ( 1 ) child alone with no parent participation ; ( 2 ) mother and child treated in the same session ; and ( 3 ) mother and child treated in separate but concurrent session . At the end of the 16-week program , children in the three conditions lost 1.6 , 3.7 , and 3.1 kg , respectively . Differences among conditions were not statistically significant ; however , a secondary analysis revealed that the greater the number of sessions attended by mothers , the greater their daughters ' weight losses . Weight reduction was associated with significant improvements in body composition , serum total cholesterol concentrations , and psychological status . Results are discussed in terms of the need to improve the maintenance of weight loss in adolescents and to explore possible differences between black and white females in their preferred body types BACKGROUND Consumption of sugar-sweetened beverages may cause excessive weight gain . We aim ed to assess the effect on weight gain of an intervention that included the provision of noncaloric beverages at home for overweight and obese adolescents . METHODS We r and omly assigned 224 overweight and obese adolescents who regularly consumed sugar-sweetened beverages to experimental and control groups . The experimental group received a 1-year intervention design ed to decrease consumption of sugar-sweetened beverages , with follow-up for an additional year without intervention . We hypothesized that the experimental group would gain weight at a slower rate than the control group . RESULTS Retention rates were 97 % at 1 year and 93 % at 2 years . Reported consumption of sugar-sweetened beverages was similar at baseline in the experimental and control groups ( 1.7 servings per day ) , declined to nearly 0 in the experimental group at 1 year , and remained lower in the experimental group than in the control group at 2 years . The primary outcome , the change in mean body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) at 2 years , did not differ significantly between the two groups ( change in experimental group minus change in control group , -0.3 ; P=0.46 ) . At 1 year , however , there were significant between-group differences for changes in BMI ( -0.57 , P=0.045 ) and weight ( -1.9 kg , P=0.04 ) . We found evidence of effect modification according to ethnic group at 1 year ( P=0.04 ) and 2 years ( P=0.01 ) . In a prespecified analysis according to ethnic group , among Hispanic participants ( 27 in the experimental group and 19 in the control group ) , there was a significant between-group difference in the change in BMI at 1 year ( -1.79 , P=0.007 ) and 2 years ( -2.35 , P=0.01 ) , but not among non-Hispanic participants ( P>0.35 at years 1 and 2 ) . The change in body fat as a percentage of total weight did not differ significantly between groups at 2 years ( -0.5 % , P=0.40 ) . There were no adverse events related to study participation . CONCLUSIONS Among overweight and obese adolescents , the increase in BMI was smaller in the experimental group than in the control group after a 1-year intervention design ed to reduce consumption of sugar-sweetened beverages , but not at the 2-year follow-up ( the prespecified primary outcome ) . ( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; Clinical Trials.gov number , NCT00381160 . ) UNLABELLED Background . This study investigated the relationships among optimism , pessimism , physical activity , and dietary behaviors among 8- to 10-year-old African-American girls in the Girls ' Health Enrichment Multisite Studies ( GEMS ) . Methods . Ninety-two girls were r and omly assigned to a 12-week physical activity and diet intervention or comparison group and completed psychosocial assessment s including the Youth Life Orientation Test ( YLOT ) of optimism and pessimism , physical performance self-concept , physical activity self-efficacy , physical activity outcome expectancies , and physical activity and sedentary preferences . Also , preferences for bottled water and sweetened beverages were assessed . Physical activity and dietary intake were assessed by self-report and parent-report at baseline and follow-up . Also , physical activity was objective ly assessed by wearing an accelerometer for 3 days . The psychometric properties of the optimism-pessimism subscales were analyzed . Results . The measures of optimism and pessimism in children were reliable ( r = 0.75 - 0.82 ) . In the multiple regression analyses without the intervention interaction terms , pessimism was positively and significantly related to increases in MET-adjusted usual activity ( P = 0.008 ) and sedentary behaviors ( P = 0.0004 ) . Additionally , a negative ( P = 0.026 ) pessimism by intervention interaction term for MET-adjusted usual activity was found such that the intervention group had a lower change in physical activity per unit increase in pessimism compared to the control group . CONCLUSIONS Among 8- to 10-year-old African-American girls , pessimism was related to increased sedentary behaviors and usual activity . Previous studies have reported relationships between optimism and health-compromising behaviors . This study found that pessimism may positively or negatively influence efforts to increase health-promoting behaviors . Future research should confirm and clarify the meaning of these findings OBJECTIVE . The role of sugar-sweetened beverages ( SSBs ) in promoting obesity is controversial . Observational data link SSB consumption with excessive weight gain ; however , r and omized , controlled trials are lacking and necessary to resolve the debate . We conducted a pilot study to examine the effect of decreasing SSB consumption on body weight . METHODS . We r and omly assigned 103 adolescents aged 13 to 18 years who regularly consumed SSBs to intervention and control groups . The intervention , 25 weeks in duration , relied largely on home deliveries of noncaloric beverages to displace SSBs and thereby decrease consumption . Change in SSB consumption was the main process measure , and change in body mass index ( BMI ) was the primary end point . RESULTS . All of the r and omly assigned subjects completed the study . Consumption of SSBs decreased by 82 % in the intervention group and did not change in the control group . Change in BMI , adjusted for gender and age , was 0.07 ± 0.14 kg/m2 ( mean ± SE ) for the intervention group and 0.21 ± 0.15 kg/m2 for the control group . The net difference , −0.14 ± 0.21 kg/m2 , was not significant overall . However , baseline BMI was a significant effect modifier . Among the subjects in the upper baseline- BMI tertile , BMI change differed significantly between the intervention ( −0.63 ± 0.23 kg/m2 ) and control ( + 0.12 ± 0.26 kg/m2 ) groups , a net effect of −0.75 ± 0.34 kg/m2 . The interaction between weight change and baseline BMI was not attributable to baseline consumption of SSBs . CONCLUSIONS . A simple environmental intervention almost completely eliminated SSB consumption in a diverse group of adolescents . The beneficial effect on body weight of reducing SSB consumption increased with increasing baseline body weight , offering additional support for American Academy of Pediatrics guidelines to limit SSB consumption & NA ; Childhood obesity is an important global public health issue . There is a need for more effective , low cost and child‐centered intervention programs for reducing body weight . In response to this need , we developed a mix of attributes approach ( including content , interactivity , control , channel , and objectivity ) to help obese children ( weight‐for‐length index , WLI ≥ 1.20 ) reduce their body weight and improve their knowledge , attitude , and behavior . The prevalence of obesity in our sample was 15.9 % ( 140 obese children out of 882 children study ing in the fourth grade ) . An experimental , r and omized research design was conducted in this study . Anthropometric measurements ( including Body Mass Index [ BMI ] , WLI , body fat percentage , triceps , and subscapular skinfold thickness ) and question naires ( including the Scale of Obesity and Body Weight Loss Knowledge , Attitude , and Practice ) were evaluated at baseline ( pretest ) and after one month of the intervention ( posttest ) for all obese children . Of 140 obese children , 118 completed this study ( 66 in the experimental group , 52 in the control group ) . The mix of attributes approach significantly reduced the degree of obesity revealed in anthropometric measurements . ( p < .05 ) This approach also significantly improved obese children 's knowledge ( p < .001 ) and slightly improved their behaviors ( p = .057 ) ; however , this program did not change the children 's attitudes so easily ( p = .597 ) . To more effectively lose weight , we suggest an additional attribute , “ individuality , ” as a means of increasing efforts to change attitudes in obese children Intervention studies in youth with obesity that can be translated into primary care are limited . We compared a lifestyle intervention to a brief intervention applied by primary care physicians ( control group ) for treating pediatric obesity in the primary care setting . Seventy-six youth with obesity ( body mass index [ BMI ] > 95th percentile or > 90th percentile plus waist circumference > 90th percentile , aged 9 to 17 years ) participated in a 12-month , r and omized , controlled trial , conducted at a primary care unit in Northern México from June 2006 through October 2007 . Participants r and omized to lifestyle intervention attended a family-centered program consisting of 12 sessions of behavioral curriculum , dietary advice from a registered dietitian ( weekly for the first 3 months and monthly thereafter ) , and monthly consultations with a primary care physician . Control group participants attended monthly consultations with a primary care physician who received a brief training on obesity . Forty-three ( 57 % ) participants completed the 12 months of study . After 12 months , mean changes ( 95 % confidence interval ) in body weight for the lifestyle group and the control group were -0.8 kg ( -3.2 , 1.5 ) vs + 5.6 kg ( 3 , 8.2 ; P<0.001 ) and mean changes in BMI were -1.8 ( -2.6 , -0.9 ) vs + 0.4 ( -0.5 , 1.3 ; P<0.001 ) , respectively . Intention-to-treat analysis at 12 months confirmed significant differences in primary outcomes ( weight -3.5 kg , P=0.02 ; BMI -1.2 , P=0.03 ) in favor of the lifestyle group . This study provides preliminary evidence that primary care physicians supported by a registered dietitian and a behavioral curriculum can be a successful strategy for treating pediatric obesity in the primary care setting The objective of this study was to evaluate demographic and psychosocial predictors of attendance in a family-based behavioral weight management clinical trial . Ninety-three children and adolescents aged 7 - 17 ( Mean age = 11.59 , s.d . = 2.6 ) who were either overweight or obese ( Mean BMI percentile = 98.2 ) and their parents received either a 10-session behavioral treatment or a three-session brief family intervention in the context of a r and omized clinical trial ( 10 ) . Psychosocial and anthropometric measures were obtained before enrollment and at the end of 10 weeks for both treatment groups . Univariate linear regression and hierarchical multiple regression analyses were used to identify predictors of attendance to treatment from an a priori set of hypothesized predictors . Three variables demonstrated significant associations with the dependent variable , percent of treatment sessions attended . Specifically , distance from participant 's home to treatment site , lower gross family income , and youth self-report of depressive symptoms were each associated with lower percent attendance ( all Ps < 0.05 ) . These results corroborate ( i.e. , income , depressive symptoms ) and exp and ( i.e. , distance from treatment site ) previous reports in the literature of potential barriers to effective treatment for pediatric obesity , and suggest the need for research on treatment delivery methods that could increase participation among low-income families ( e.g. , eHealth , mHealth options ) . Depressive symptoms could represent an additional barrier to treatment attendance , suggesting that assessment and treatment for these symptoms may be appropriate before commencing weight management treatment OBJECTIVES . The intent of this study was to evaluate whether small changes in diet and physical activity , as promoted by the America on the Move initiative , could prevent excessive weight gain in overweight children . METHODS . In this family-intervention study , the America on the Move small-changes approach for weight-gain prevention was evaluated in families with at least 1 child ( 7–14 years old ) who was overweight or at risk for overweight . These children were the primary target of the intervention , and parents were the secondary target . Families were r and omly assigned to either the America on the Move group ( n = 100 ) or the self-monitor – only group ( n = 92 ) . Families who were assigned to the America on the Move group were asked to make 2 small lifestyle changes : ( 1 ) to walk an additional 2000 steps per day above baseline as measured by pedometers and ( 2 ) to eliminate 420 kJ/day ( 100 kcal/day ) from their typical diet by replacing dietary sugar with a noncaloric sweetener . Families who were assigned to the self-monitor group were asked to use pedometers to record physical activity but were not asked to change their diet or physical activity level . RESULTS . During a 6-month period , both groups of children showed significant decreases in BMI for age . However , the America on the Move group compared with the self-monitor group had a significantly higher percentage of target children who maintained or reduced their BMI for age and , consistently , a significantly lower percentage who increased their BMI for age . There was no significant weight gain during the 6-month intervention in parents of either group . CONCLUSIONS . The small-changes approach advocated by America on the Move could be useful for addressing childhood obesity by preventing excess weight gain in families Recent findings of a direct association of obesity and impaired health-related quality of life ( HRQOL ) in children suggest a need for early weight-management interventions that address psychosocial issues and lifestyle . Our aim was to compare the effects of exercise , diet , or diet + exercise on HRQOL in obese children . We hypothesized that HRQOL will improve as a result of the weight-loss intervention and will be correlated with the amount of weight loss achieved by each of the intervention groups . A total of 162 children aged 6 to 11 years with a body mass index ( BMI ) exceeding the 95th percentile were r and omly allocated to a 12-week regimens of diet , exercise , or diet + exercise . Weight , height , and percent fat mass were measured , and parents completed the Pediatric Quality of Life Inventory ( PedsQL ) 4.0 at baseline and at the end of the intervention . The reductions in BMI were significantly greater in the diet and diet + exercise groups than in the exercise group . Pediatric Quality of Life Inventory scores improved significantly , with no differences among the groups . A greater reduction in BMI occurred in children whose parents completed the PedsQL at baseline ( n = 105 ) than in children whose parents did not ( n = 15 ) ( -1.8 + /- 1.3 vs -1.0 + /- 1.5 ; P = .048 ) and in children whose parents completed the PedsQL at the end of the intervention ( n = 73 ) than in children whose parents did not ( n = 47 ) ( -2.0 + /- 1.3 vs -1.3 + /- 1.3 ; P = .013 ) . Weight-management programs that promote a healthy eating and physical activity can serve as an effective tool to improve the low HRQOL of obese children . Parental compliance is an important factor and may be assessed by the parents ' cooperativeness in completing question naires OBJECTIVE : To determine if beneficial effects of a weight-management program could be sustained for up to 24 months in a r and omized trial in an ethnically diverse obese population . PATIENTS AND METHODS : There were 209 obese children ( BMI > 95th percentile ) , ages 8 to 16 of mixed ethnic background s r and omly assigned to the intensive lifestyle intervention or clinic control group . The control group received counseling every 6 months , and the intervention group received a family-based program , which included exercise , nutrition , and behavior modification . Lifestyle intervention sessions occurred twice weekly for the first 6 months , then twice monthly for the second 6 months ; for the last 12 months there was no active intervention . There were 174 children who completed the 12 months of the r and omized trial . Follow-up data were available for 76 of these children at 24 months . There were no statistical differences in dropout rates among ethnic groups or in any other aspects . RESULTS : Treatment effect was sustained at 24 months in the intervention versus control group for BMI z score ( −0.16 [ 95 % confidence interval : −0.23 to −0.09 ] ) , BMI ( −2.8 kg/m2 [ 95 % confidence interval : −4.0–1.6 kg/m2 ] ) , percent body fat ( −4.2 % [ 95 % confidence interval : −6.4 % to −2.0 % ] ) , total body fat mass ( −5.8 kg [ 95 % confidence interval : −9.1 kg to −2.6 kg ] ) , total cholesterol ( −13.0 mg/dL [ 95 % confidence interval : −21.7 mg/dL to −4.2 mg/dL ] ) , low-density lipoprotein cholesterol ( −10.4 mg/dL [ 95 % confidence interval : −18.3 mg/dL to −2.4 mg/dL ] ) , and homeostasis model assessment of insulin resistance ( −2.05 [ 95 % confidence interval : −2.48 to −1.75 ] ) . CONCLUSIONS : This study , unprecedented because of the high degree of obesity and ethnically diverse background s of children , reveals that benefits of an intensive lifestyle program can be sustained 12 months after completing the active intervention phase Healthy Children , Strong Families ( HCSF ) is a 2-year , community-driven , family-based r and omized controlled trial of a healthy lifestyles intervention conducted in partnership with four Wisconsin American Indian tribes . HCSF is composed of 1 year of targeted home visits to deliver nutritional and physical activity curricula . During Year 1 , trained community mentors work with 2–5-year-old American Indian children and their primary caregivers to promote goal -based behavior change . During Year 2 , intervention families receive monthly newsletters and attend monthly group meetings to participate in activities design ed to reinforce and sustain changes made in Year 1 . Control families receive only curricula material s during Year 1 and monthly newsletters during Year 2 . Each of the two arms of the study comprises 60 families . Primary outcomes are decreased child body mass index ( BMI ) z-score and decreased primary caregiver BMI . Secondary outcomes include : increased fruit/vegetable consumption , decreased TV viewing , increased physical activity , decreased soda/sweetened drink consumption , improved primary caregiver biochemical indices , and increased primary caregiver self-efficacy to adopt healthy behaviors . Using community-based participatory research and our history of university – tribal partnerships , the community and academic research ers jointly design ed this r and omized trial . This article describes the study design and data collection strategies , including outcome measures , with emphasis on the communities ’ input in all aspects of the research OBJECTIVES : Outcomes of childhood obesity interventions are rarely reported beyond 1 year . We hypothesized that the impact on the BMI z score from a child-centered physical-activity program in combination with a parent-centered dietary-modification program would be greater than either program conducted alone at 24 months ' after baseline . PARTICIPANTS AND METHODS : A total of 165 overweight prepubertal children ( 68 boys , aged 5.5–9.9 years , mean BMI z score : 2.8 ) were r and omly assigned to either a child-centered physical-activity program , a parent-centered dietary-modification program , or both conducted together in an assessor-blinded 6-month intervention . RESULTS : Using linear mixed models , all groups reduced their mean ( 95 % confidence interval ) BMI z score at 24 months from baseline ( P < .001 ) ( the activity and diet group : −0.24 [ −0.35 to −0.13 ] ; the diet-only group : −0.35 [ −0.48 to −0.22 ] ; activity-only group −0.19 [ −0.30 to −0.07 ] ) . There was a significant group-by-time interaction ( P = .04 ) with the activity + diet and the diet-only groups showing a greater reduction than the activity-only group . For waist z score and waist-to-height ratio , there was a significant time effect ( P < .0001 ) at 24 months but no between-group differences ( P > .05 ) . Some metabolic outcomes improved at 24 months , although there were no between-group differences ( P > .05 ) . CONCLUSIONS : A reduction in BMI z score was sustained at 24 months by treatment with either program combination . The greatest effects were achieved through inclusion of a parent-centered diet program , indicating the importance of targeting parents within treatment and the possibility of targeting them exclusively in treating obese prepubertal children Background and Aim : Energy intake is a major contributor to energy imbalance and is a key modifiable factor for successful treatment of obesity . Long-term changes in dietary intake from pediatric obesity treatment programs are rarely reported . The aim of this study was to describe the changes in food intake of children from all intervention groups from baseline to 2-year follow-up after a 6-month obesity intervention . Subjects and Methods : Overweight children ( n = 160 , 5–9 years ) , 58 % girls and body mass index z score ( mean ± SD ) 2.89 ± 0.79 , were recruited to the Hunter Illawarra Kids Challenge using the Parent Support r and omized controlled trial . Dietary intake was reported by parents for children at baseline and 2-year follow-up ( n = 87 ) using a food frequency question naire . Linear mixed models were used to determine differences by time . Results : Parents reported decreases in total energy ( total kcal , kcal/kg ) , child percentage of total energy from energy-dense , nutrient-poor foods ( sweetened drinks , potato crisps , sweets , and carry-out foods ) from 42 % ± 1.0 % at baseline to 34.8 % ± 1.0 % at 2 years ( P < 0.001 ) , with an increase in percentage of energy from nutrient-dense foods ( fruits , vegetables , dairy , breads , and cereals ) from 57 % ± 0.9 % at baseline to 65 % ± 1.0 % at 2 years ( P < 0.001 ) . Conclusions : This is the only one of a few studies that report dietary data of overweight children who participated in a treatment program with long-term follow-up . It provides evidence that improvements in food intake can be sustained up to 2 years through decreased consumption of energy-dense , nutrient-poor foods , particularly sweetened drinks , and increased consumption of core foods following an intervention OBJECTIVE To examine whether differentially targeting physical activity within the context of pilot family-based pediatric weight control treatment results in differential change in abdominal fat , particularly visceral fat . METHOD Twenty-nine overweight children ( > 85(th ) body mass index [ BMI ] percentile ) and at least one participating parent were r and omly assigned to one of two family-based behavioral weight management conditions that either targeted 1 ) primarily dietary change ( ST AND ARD ; n = 15 ) or 2 ) dietary plus physical activity change ( ADDED ; n = 14 ) . Differences at post-treatment in overall child weight status ( e.g. , BMI ) , whole-body composition ( measured by dual x-ray absorptiometry ) , and abdominal fat ( measured by waist circumference and magnetic resonance imaging ) were assessed using intent-to-treat analyses , as were post-treatment parent BMI and waist circumference . Child and parent physical activity and dietary behavior changes were also evaluated . Results . At post-treatment , overall child weight status , whole-body composition , and child dietary measures did not differ by condition . Children in the ADDED condition tended to have higher physical activity and lower visceral abdominal fat at post-treatment relative to children in the ST AND ARD condition . CONCLUSIONS Increasing physical activity may be important to optimize reductions in abdominal fat , especially visceral fat , among overweight children provided with family-based behavioral weight management treatment . CLINICAL TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00359957 OBJECTIVE To evaluate demographic and psychosocial predictors of attrition and weight loss in a behaviorally based adolescent weight control trial . METHODS AND PROCEDURES Adolescents ( N = 76 ) aged 13 - 16 years and 20 - 80 % overweight ( M = 60.56 % , s.d . = 15.17 % ) received st and ard group-based behavioral treatment as part of a r and omized trial comparing different activity interventions for overweight adolescents . Anthropometric and psychosocial measures were obtained at baseline and after the 16-week intervention . RESULTS Higher parent ( P < 0.01 ) and adolescent BMI ( P < 0.05 ) at baseline , as well as ethnic minority status ( P < 0.05 ) were significantly associated with attrition in univariate analyses . Parent BMI remained the only significant predictor of attrition in multivariate analyses . BMI change for completers ( N = 62 ) was highly variable , ranging from -6.09 to + 1.62 BMI units . Male gender ( P < 0.01 ) was a significant predictor of reduction in BMI , whereas not being from an ethnic minority group ( P < 0.05 ) and attendance at group sessions ( P = 0.05 ) were associated with > or = 5 % absolute weight loss in multivariate analyses . Absolute weight loss during the first 4 weeks of the program was strongly associated with weight loss ( pr = 0.44 , P < 0.001 ) during the remainder of the intervention . Psychosocial variables were unrelated to attrition or treatment outcome . DISCUSSION These findings highlight the potential importance of attending to parental BMI in efforts to retain adolescent participants in treatment , as well as the need to develop weight control interventions that are more effective for ethnic minority youth BACKGROUND The childhood obesity epidemic disproportionately affects Hispanics . This paper reports on the design of the ongoing Healthy Families Study , a r and omized controlled trial testing the efficacy of a community-based , behavioral family intervention to prevent excessive weight gain in Hispanic children using a community-based participatory research approach . METHODS The study will enroll 272 Hispanic families with children ages 5 - 7 residing in greater Nashville , Tennessee , United States . Families are r and omized to the active weight gain prevention intervention or an alternative intervention focused on oral health . Lay community health promoters implement the interventions primarily in Spanish in a community center . The active intervention was adapted from the We Can ! parent program to be culturally-targeted for Hispanic families and for younger children . This 12-month intervention promotes healthy eating behaviors , increased physical activity , and decreased sedentary behavior , with an emphasis on parental modeling and experiential learning for children . Families attend eight bi-monthly group sessions during four months then receive information and /or support by phone or mail each month for eight months . The primary outcome is change in children 's body mass index . Secondary outcomes are changes in children 's waist circumference , dietary behaviors , preferences for fruits and vegetables , physical activity , and screen time . RESULTS Enrollment and data collection are in progress . CONCLUSION This study will contribute valuable evidence on efficacy of a childhood obesity prevention intervention targeting Hispanic families with implication s for reducing disparities OBJECTIVE To assess dietary costs during a family-based pediatric obesity intervention . DESIGN Families were r and omized to one of two groups . Dietary and cost data were collected from a parent or child using three 24-hour recalls : at baseline , 6 months , and 12 months . SUBJECTS Thirty-one families with an obese 8- to 12-year-old child entered treatment , with complete dietary data provided from 20 families . INTERVENTION The 20-week behavior modification intervention emphasized increasing diet nutrient-density . Families attended group and individual sessions or group sessions . MAIN OUTCOME MEASURES Energy intake ; percent of energy from protein , fat , and carbohydrate ; servings and percent servings from food groups classified by nutrient density ; and daily food costs . STATISTICAL ANALYSES PERFORMED Mixed analyses of variance , with group as the between-subject factor , and time as the within-subject factor . RESULTS No significant effect of group was found in any analyses . Significant decreases in percent overweight were observed at 6 and 12 months for children ( -10.0+/-8.7 and -8.0+/-10.3 , respectively ) ( mean+/-st and ard deviation ) and parents ( -6.7+/-10.3 and -5.3+/-14.1 ) . Energy intake for parents and children combined significantly decreased from baseline ( 1,881+/-462 ) to 6 months ( 1,412+/-284 ) , and 1 year ( 1,338+/-444 ) . Servings from low-nutrient-dense foods significantly decreased from baseline ( 34.7+/-16.2 ) to 6 months ( 16.0+/-8.6 ) and 1 year ( 18.6+/-9.2 ) , causing a significant increase in diet nutrient density . Dietary cost did not change at 6 months , but significantly decreased from baseline to 1 year ( $ 6.77+/-2.41 to $ 5.04+/-1.80 ) . Cost per 1,000 kcal did not significantly change . APPLICATIONS/ CONCLUSIONS Adopting a lower-energy , nutrient-dense diet did not increase dietary costs over time . Consequently , cost should not be a barrier in the adoption of a healthful diet PURPOSE The purpose of this study was to evaluate the Hunter Illawarra Kids Challenge Using Parent Support physical activity program in overweight children . METHODS A multisite r and omized controlled trial was conducted with three intervention arms : 1 ) child-centered physical activity skill development program ( Activity ) , 2 ) parent-centered dietary modification program ( DIET ) , or 3 ) both programs combined ( PA+DIET ) . Movement skill proficiency , perceived athletic competence , accelerometer-assessed physical activity , and parent-reported time spent in screen behaviors were assessed at baseline , 6 months , and 12 months in 165 prepubertal children aged 5.5 - 9 yr ( 59 % girls , 78 % obese ) . Differences in changes in outcomes between groups were assessed using linear mixed models . RESULTS Compared with the diet group , the activity group ( mean ( 95 % confidence interval ) : + 7.7 units ( 3.8 - 11.6 units ) ) and the activity + diet group ( + 6.7 units ( 2.9 - 10.5 units ) ) displayed 11%-13 % greater improvement in overall movement skill proficiency ( gross motor quotient ) at 6 months . Perceived athletic competence increased across groups at follow-up ( across groups : 6 months = + 0.21 units ( 0.11 - 0.31 units ) , 12 months = + 0.21 units ( 0.07 - 0.35 units ) ) . Groups did not differ statistically for change in physical activity outcomes . Total screen time ( min·wk(-1 ) ) decreased in all groups at 6 months ( across groups : -385.4 ( -501.0 to -269.8 ) ) and in the activity group ( -261.8 ( -470.5 to -53.1 ) ) and activity + diet group ( -340.5 ( -534.6 to -146.4 ) ) at 12 months . The diet group reported greater reductions in TV or DVD viewing time at 6 months compared with the activity group ( 248.6 ( 24.0 - 473.3 ) ) . CONCLUSIONS The activity and the activity + diet programs were efficacious in improving overweight children 's movement skill proficiency . All programs were efficacious in reducing time spent in screen behaviors . Other correlates may need to be targeted in addition to movement skills to increase physical activity among overweight children OBJECTIVE : To investigate the effect of lifestyle changes on whole-body protein turnover ( WBPT ) in obese adolescents . DESIGN / METHODS : R and omized and controlled nonpharmacological intervention study of WBPT in obese adolescents using stable isotope dilution techniques . SUBJECTS AND MEASUREMENTS : We studied a total of 21 adolescents ( 11 boys and 10 girls , matched for their pubertal status ) of which 15 were obese ( age=15.8±0.4 y old and BMI = 38.6±3.3 kg/m2 ) and six were lean controls ( age=16.0±0.4 y old and BMI = 21.3±1.2 kg/m2 ) . The obese subjects were subjected to a r and omized controlled lifestyle intervention program that involved moderate physical activity and diet changes for 3 months . A group of lean age-matched subjects was also studied at baseline to compare the WBPT in obese and lean adolescents . The studies were performed during a primed , continuous infusion of L-[1 - 13C]leucine . Leucine appearance rate ( Leu Ra ) was used as an index of whole protein breakdown and the nonoxidative portion of leucine disposal ( NOLD ) as an index of whole-body protein synthesis . RESULTS : The obese groups showed significantly higher body mass index ( BMI ) , fat mass ( FM ) , percent body fat ( % BF ) , fat-free mass ( FFM ) , resting energy expenditure ( REE ) and WBPT compared to the lean controls . The intervention program result ed in a redistribution of the parameters of body composition without apparent changes in BMI or body weight . There was a significant decrease in WBPT in the obese intervention group , but not in the obese control group . Insulin levels also decreased significantly in the obese group after intervention but not in the obese control group , whereas the glucose concentrations remained normal in all groups at baseline and also after intervention/or control . CONCLUSIONS : Results from the current study suggest : ( i ) abonormalities of protein metabolism occur early in the clinical course of obesity and ( ii ) these abnormalities are modifiable by moderate lifestyle changes in obese adolescents . The mechanism for these changes in WBPT in obese adolescents as well as their impact on specific cardiovascular risk factors and turnover of specific proteins will require further investigation BACKGROUND & AIMS Lifestyle interventions address primarily obese children , while interventions tailored to overweight but not obese children are scarce . The effectiveness of the lifestyle intervention " Obeldicks light " based on physical activity training , nutrition education , and behavior counseling for overweight children and their parents has been demonstrated by a r and omized controlled trial . Here , we present the 12 months follow-up analysis of these children after end of intervention . METHODS Degree of overweight ( BMI and SDS- BMI ) , waist circumference , skinfold thickness , bioimpedance analyses ( BIA ) , and blood pressure were determined in 76 overweight ( BMI > 90(th)≤97(th ) percentile ) children ( mean age 11.8 ± 1.8years , 67 % females , mean BMI 24.3 ± 1.9 kg/m(2 ) ) participating in the evaluation study of " Obeldicks light " at onset of intervention ( T0 ) , end of 6 months intervention ( T1 ) , 6 months after end of intervention ( T2 ) and 12 months after end of intervention ( T3 ) . Comparisons were performed on an intention-to-treat approach . RESULTS The drop-out rate was 4 % in the intervention period and additional 3 % during follow-up . The children reduced significantly ( p < 0.001 ) their SDS- BMI in the intervention period between T0 and T1 ( -0.27 ± 0.23 ; p < 0.001 ) . This SDS- BMI reduction remained stable at T2 ( T0-T2:-0.26 ± 0.31 ; p < 0.001 ) and T3 ( T0-T3:-0.26 ± 0.39 ; p < 0.001 ) . SDS- BMI reductions were independent from age and gender . Body fat measured by skinfold thickness and BIA , waist circumference , and blood pressure decreased significantly in the intervention period and remained stable in the follow-up period as well . CONCLUSIONS The lifestyle intervention " Obeldicks light " was effective in reducing degree of overweight , fat mass , waist circumference , and blood pressure both at end of intervention and in a 12 months follow-up period BACKGROUND Interventions for obese adolescents in real-world , clinical setting s need to be evaluated because most weight management care occurs in this context . OBJECTIVES To determine whether a lifestyle intervention that includes motivational interviewing and cognitive behavioural therapy ( Health Initiatives Program [ HIP ] ) leads to weight management that is superior to a similar lifestyle intervention ( Youth Lifestyle Program [ YLP ] ) that does not include these techniques ; and to determine whether the HIP and YLP interventions are superior to a wait list control ( WLC ) group . METHODS Obese adolescents were r and omly assigned to a YLP ( n=15 ) , HIP ( n=17 ) or WLC ( n=14 ) group . The YLP and HIP were 16-session , one-on-one interventions . The primary outcome was the percentage change of body mass index z-score . RESULTS Completers-only analyses revealed 3.9 % ( YLP ) and 6.5 % ( HIP ) decreases in the percentage change of body mass index z-score compared with a 0.8 % ( WLC ) increase ( P<0.001 ) . Levels of attrition did not differ among groups , but were relatively high ( approximately 20 % to 40 % ) . CONCLUSION Lifestyle interventions delivered in a real-world , clinical setting led to short-term improvements in the obesity status of adolescents OBJECTIVE Hip-Hop to Health Jr. was a diet/physical activity intervention design ed to reduce gains in BMI ( kilograms per meter squared ) in preschool minority children . RESEARCH METHODS AND PROCEDURES Twelve predominantly Latino Head Start centers participated in a group-r and omized trial conducted between Fall 2001 and Winter 2003 . Six centers were r and omized to a culturally proficient 14-week ( three times weekly ) diet/physical activity intervention . Parents participated by completing weekly homework assignments . The children in the other six centers received a general health intervention that did not address either diet or physical activity . The primary outcome was change in BMI , and secondary outcomes were changes in dietary intake and physical activity . Measures were collected at baseline , post-intervention , and at Years 1 and 2 follow-up . RESULTS There were no significant differences between intervention and control schools in either primary or secondary outcomes at post-intervention , Year 1 , or Year 2 follow-ups . DISCUSSION When Hip-Hop to Health Jr. was conducted in predominantly black Head Start centers , it was effective in reducing subsequent increases in BMI in preschool children . In contrast , when the program was conducted in Latino centers , it was not effective . Although the intervention did not prevent excessive weight gain in Latino children , it was very well received . Future interventions with this population may require further cultural tailoring and a more robust parent intervention We investigated the influence of nutrition and exercise interventions within cognitive/behavioral and public health formats on weight and blood lipid profiles in obese children . Compliance was also examined as well as the relationship of the compliance measures with clinical outcome variables . Three conditions were compared over 16 sessions : nutrition and eating-habit change followed by exercise ( NE ) , exercise followed by nutrition and eating-habit change ( EN ) , and an information control ( INFO ) . NE and EN were presented in a cognitive/ behavioral framework which focused on the development of self-regulation whereas the INFO condition received the same material in a public health/educational model . NE and EN participants evidence d modest , yet significant , reductions in weight and blood lipids , and the impact of these two interventions endured at a five-year follow-up . In contrast , INFO participants displayed stable weight and blood lipids during the course of the program , and most remained morbidly obese at follow-up . Improved nutrition , increased physical activity and fitness were significantly correlated with weight and lipid reductions OBJECTIVE This study evaluates the post-treatment and short-term follow-up efficacy of , as well as participant satisfaction for , a 4-month behavioral weight control program for overweight adolescents initiated in a primary care setting and extended through telephone and mail contact . RESEARCH METHODS AND PROCEDURES 44 overweight adolescents were r and omly assigned to either a multiple component behavioral weight control intervention ( Healthy Habits [ HH ] ; n = 23 ) or a single session of physician weight counseling ( typical care [ TC ] ; n = 21 ) . Weight , height , dietary intake , physical activity , sedentary behavior , and problematic weight-related and eating behaviors and beliefs were assessed before treatment , after the 4-month treatment , and at 3-month follow-up . Participant satisfaction and behavioral skills use were measured . RESULTS HH adolescents evidence d better change in body mass index z scores to post-treatment than TC adolescents . Body mass index z scores changed similarly in the conditions from post-treatment through follow-up . Behavioral skills use was higher among HH than TC adolescents , and higher behavioral skills use was related to better weight outcome . Energy intake , percentage of calories from fat , physical activity , sedentary behavior , and problematic weight-related or eating behaviors/beliefs did not differ by condition or significantly change over time independent of condition . The behavioral intervention evidence d good feasibility and participant satisfaction . DISCUSSION A telephone- and mail-based behavioral intervention initiated in primary care result ed in better weight control efficacy relative to care typically provided to overweight adolescents . Innovative and efficacious weight control intervention delivery approaches could decrease provider and participant burden and improve dissemination to the increasing population of overweight youth INTRODUCTION Twenty-three percent of preschoolers are overweight/obese , which puts these children at risk for the development of chronic health comorbidities . The purpose of this r and omized control pilot study was to determine the feasibility and preliminary effects of a theoretically based , primary care intervention on the physical outcomes of 60 overweight/obese preschool/early school-aged 4- to 8-year-old children . METHODS After recruitment and baseline assessment , parent-child dyads were r and omly assigned to either the treatment or the control condition . Four intervention sessions were conducted with the parents in their child 's primary health care office . The impact of the intervention was evaluated by assessing child anthropometric measures ( e.g. , waist , waist-by-height ratio , and body mass index [ BMI ] ) immediately , 3 months , and 6 months after the intervention period . RESULTS Analysis of variance models suggested that children in the experimental group were found to have reduced waist circumference and waist-by-height ratio immediately after the intervention that persisted for 3 and 6 months ( f = 0.33 , 0.35 , respectively ) . BMI and BMI percentile were not differentially affected . DISCUSSION These promising findings suggest that a primary care-based , parent-focused overweight/obesity treatment program is feasible and demonstrated positive preliminary effects , improving the children 's overall health trajectory BACKGROUND Children tend to be sedentary during the after-school hours , and this has deleterious effects on their health . The objective of the present study was to determine the effects of a 3-year after-school physical activity ( PA ) program , without restriction of dietary energy intake , on percent body fat ( % BF ) , cardiorespiratory fitness ( CRF ) , and cardiometabolic markers in children . METHODS A cluster r and omization design was employed . A total of 574 3rd grade children from 18 elementary schools in the southeastern United States participated . The intervention consisted of 80 minutes of age-appropriate moderate-to-vigorous PA each school day . The main outcomes of interest were % BF measured by dual-energy X-ray absorptiometry ; CRF measured by heart rate in response to a submaximal step test ; nonfasting total and high-density lipoprotein cholesterol ( HDL-C ) ; and resting blood pressure ( BP ) . RESULTS Intent-to-treat analyses showed significant treatment by time interactions for % BF ( p = 0.009 ) and CRF ( p = 0.0003 ) . The change pattern of the means suggested that % BF and CRF in intervention children improved relative to control children during the school months , rebounding to the levels of control children over the summers following years 1 and 2 . Year-by-year analyses of what occurred during the months when the program was offered revealed dose – response relations for % BF and CRF , such that the clearest beneficial effects were seen for those youth who attended at least 60 % of the after-school sessions . No significant intervention effects were seen for cholesterol or BP . CONCLUSIONS An after-school PA program was effective in reducing adiposity and improving CRF , especially in the children who attended the sessions at least 3 days/week . However , the favorable effects on % BF and CRF were lost over the summer . Thus , it is critical to incorporate strategies that attract and retain the children to receive an adequate dose of PA year-round OBJECTIVE To assess the short-term impact of a nutritional intervention aim ed at reducing childhood overweight in German pre-school children . DESIGN Using a cluster-r and omized study design with waiting-list controls , we tested a 6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious , fresh foods . At baseline , 6 and 12 months , a parent-completed question naire assessed fruit and vegetable intakes ( primary outcomes ) and water and sugared drinks consumption ( secondary outcomes ) . Direct measurement assessed BMI , skinfold thickness and waist-to-height-ratio . An intention-to-treat analysis used r and om-effects panel regression models to assess the intervention effect , adjusted for each child 's age , gender , immigrant background and maternal education . SETTING Eighteen pre-schools from three south German regions . SUBJECTS Healthy children aged 3 - 6 years . RESULTS Three hundred and seventy-seven ( 80 % ) eligible pre-school children participated in the study . Of these , 348 provided sufficient data for analysis . The sample mean age was 4·26 ( sd 0·78 ) years ; the majority ( 53·2 % ) were boys . Children 's fruit and vegetable intakes increased significantly ( P < 0·001 and P < 0·05 , respectively ) ; no significant changes in the consumption of water , sugared drinks or anthropometric measurements were noted . CONCLUSIONS Nutritional interventions in pre-schools have the potential to change eating behaviours in young children , which in the long term might reduce risk for developing overweight BACKGROUND Interactive technologies have the potential to increase the reach and frequency of practical clinical interventions that assist the parents of overweight and at-risk children to promote healthy lifestyle behaviors for their families . DESIGN A practical RCT evaluated the relative effectiveness of three interventions to support parents of overweight or at-risk children to change the home environment to foster more healthful child eating and activity behaviors , thereby reducing child BMI and BMI z-scores . A secondary purpose was to determine the patterns of use and potential dose effect for the highest-intensity intervention . SETTING / PARTICIPANTS Parent- and -child ( aged 8 - 12 years ) dyads ( N=220 ) who received care from Kaiser Permanente Colorado were assigned r and omly to one of the three Family Connections ( FC ) interventions : FC-workbook , FC-group , or FC-interactive voice response ( IVR ) counseling . MAIN OUTCOME MEASURES Child BMI z-scores , as well as symptoms of eating disorders and body image , were assessed at baseline , 6 months , and 12 months . RESULTS The BMI z-scores of children assigned to the FC-IVR intervention were the only ones that decreased from baseline to 6 months ( 0.07 SD ) and from baseline to 12 months ( 0.08 SD , p<0.05 ) . Children whose parents completed at least six of the ten FC-IVR counseling calls had decreased BMI z-scores to a greater extent than children in the FC-workbook or FC-group interventions at both 6 months ( p<0.05 ) and 12 months ( p<0.01 ) . No intervention increased child symptoms of eating disorders or body dissatisfaction at any time point . CONCLUSIONS This trial demonstrated that automated telephone counseling can support the parents of overweight children to reduce the extent to which their children are overweight . TRIAL REGISTRATION NCT00433901 BACKGROUND Informed and engaged parents and healthful home environments are essential for the health of youth . Although research has shown health benefits associated with family meals , to date , no r and omized controlled trial ( RCT ) has been developed to examine the impact of a family meals intervention on behavioral and health outcomes . METHODS / DESIGN The Healthy Home Offerings via the Mealtime Environment ( HOME ) Plus study is a two-arm ( intervention versus attention-only control ) RCT being conducted in Minneapolis/St . Paul . Built on previous pilot research , HOME Plus aims to increase the frequency and healthfulness of family meals and snacks and reduce children 's sedentary behavior , particularly screen time , to promote healthier eating and activity behaviors and prevent obesity . HOME Plus is delivered to families in community setting s. The program includes 10 monthly sessions focused on nutrition and activity education , meal planning and preparation skill development . In addition , five motivational goal - setting phone calls are conducted with parents . The primary outcome measure is age- and gender-adjusted child BMI -z score at post-intervention by treatment group . Secondary household-level outcomes include family meal frequency , home availability of healthful foods ( fruits/vegetables ) and unhealthful foods ( high-fat/sugary snacks ) and beverages ( sugar-sweetened beverages ) , and the quality of foods served at meals and snacks . Secondary child outcomes include dietary intake of corresponding foods and beverages and screen time . CONCLUSIONS The HOME Plus RCT actively engages whole families of 8 - 12 year old children to promote healthier eating and activity behaviors and prevent obesity through promotion of family meals and snacks and limited media use BACKGROUND Improving nutrition and physical activity behaviors associated with childhood obesity are significant national public health goals . Energy Balance for Kids with Play ( EB4 K with Play ) , developed through a partnership between the Academy of Nutrition and Dietetics Foundation and Playworks , is a multi-component school-based intervention design ed to address youth 's nutrition and physical activity behaviors . This article describes the EB4 K with Play intervention and evaluation study and presents the baseline data . METHODS The evaluation is a 2-year cluster-r and omized design targeting third- to fifth- grade students enrolled in a low-income , urban school district in northern California . Six schools were recruited to participate . Four were r and omized to the intervention group and two into a control group . Baseline student-level data pertaining to nutrition , physical activity , fitness , and BMI were collected in the fall of 2011 . The EB4 K with Play program , which includes direct-to-student nutrition and physical activity interventions , a school wellness component , and parent/community partner outreach components , began immediately after baseline data collection . RESULTS An ethnically diverse sample of students ( n=844 ) was recruited to participate in the study . Baseline data showed a higher percent of eligibility for free and reduced-price school lunch and higher rates of obesity/overweight than the California state averages . Fitness levels and levels of moderate-to-vigorous physical activity were comparable to state averages . CONCLUSIONS End-point data will be collected after 2 years of the intervention . The findings from this study should help guide future efforts to design effective intervention programs to support the prevention of pediatric obesity BACKGROUND There is a paucity of studies evaluating targeted obesity prevention interventions in pre-school children . OBJECTIVES We conducted a r and omized controlled trial to evaluate the efficacy of a parent-based obesity prevention intervention for pre-schoolers - MEND ( Mind , Exercise , Nutrition … Do It ! ) 2 - 4 on child diet , eating habits , physical activity/sedentary behaviours , and body mass index ( BMI ) . METHODS Parent-child dyads attended 10 weekly 90-min workshops relating to nutrition , physical activity and behaviours , including guided active play and healthy snack time . Assessment s were conducted at baseline , immediately post-intervention , and 6 and 12 months post-intervention ; child intake of vegetables , fruit , beverages , processed snack foods , fussiness , satiety responsiveness , physical activity , sedentary behaviour and neophobia were assessed via parent proxy report . Parent and child height and weight were measured . RESULTS Two hundred one parent-child dyads were r and omized to intervention ( n = 104 ) and control ( n = 97 ) . Baseline mean child age was 2.7 ( st and ard deviation [ SD ] 0.6 ) years , and child BMI -for-age z-score ( World Health Organization ) was 0.66 ( SD 0.88 ) . We found significant positive group effects for vegetable ( P = 0.01 ) and snack food ( P = 0.03 ) intake , and satiety responsiveness ( P = 0.047 ) immediately post-intervention . At 12 months follow-up , intervention children exhibited less neophobia ( P = 0.03 ) than controls . CONCLUSION Future research should focus on additional strategies to support parents to continue positive behaviour change . ACTRN12610000200088 BACKGROUND Identifying sustainable approaches to improving the physical activity ( PA ) and nutrition environments in schools is an important public health goal . This study examined the impact of Energy Balance for Kids with Play ( EB4 K with Play ) , a school-based intervention developed by the Academy of Nutrition and Dietetics Foundation and Playworks , on students ' PA , dietary habits and knowledge , and weight status over 2 years . METHODS This cluster-r and omized , controlled trial took place in four intervention and two control schools over 2 years ( n=879 ; third- to fifth- grade students ) . PA ( fourth and fifth grade s only ) , dietary knowledge and behaviors , school policies , and BMI z-score were assessed at baseline ( fall 2011 ) , midpoint ( spring 2012 ) , and endpoint ( fall 2012 for accelerometers ; spring 2013 for all other outcomes ) . RESULTS At endpoint , there were no group differences in change in PA or dietary behaviors , although BMI z-score decreased overall by -0.07 ( p=0.05 ) . Students ' dietary knowledge significantly increased , as did the amount of vegetables schools served . Post-hoc analyses stratified by grade revealed that , relative to control students , fourth- grade intervention students reduced school-day sedentary time by 15 minutes ( p=0.023 ) and third- grade intervention students reduced BMI z-score by -0.2 ( 0.05 ; p<0.05 ) . There were no significant differences for older students . CONCLUSIONS EB4 K with Play , which leverages the existing infrastructure of two national programs , increases children 's dietary knowledge and may improve weight status and decrease sedentary behaviors among younger children . Future iterations should examine programming specific for different age groups BACKGROUND Interventions to prevent and control childhood obesity have shown mixed results in terms of short- and long-term changes . OBJECTIVES ' MOVE/me Muevo ' was a 2-year family- and recreation centre-based r and omized controlled trial to promote healthy eating and physical activity among 5- to 8-year-old children . It was hypothesized that children in the intervention group would demonstrate lower post-intervention body mass index ( BMI ) values and improved obesity-related behaviours compared with the control group children . METHODS Thirty recreation centres in San Diego County , California , were r and omized to an intervention or control condition . Five hundred forty-one families were enrolled and children 's BMI , diet , physical activity and other health indicators were tracked from baseline to 2 years post-baseline . Analyses followed an intent-to-treat approach using mixed-effects models . RESULTS No significant intervention effects were observed for the primary outcomes of child 's or parent 's BMI and child 's waist circumference . Moderator analyses , however , showed that girls ( but not boys ) in the intervention condition reduced their BMI . At the 2-year follow-up , intervention condition parents reported that their children were consuming fewer high-fat foods and sugary beverages . CONCLUSIONS Favourable implementation fidelity and high retention rates support the feasibility of this intervention in a large metropolitan area ; however , interventions of greater intensity may be needed to achieve effects on child 's BMI . Also , further research is needed to develop gender-specific intervention strategies so that both genders may benefit from such efforts OBJECTIVE The aim of this study was to conduct a preliminary evaluation of Children 's Appetite Awareness Training ( CAAT ) , a treatment for childhood obesity which encourages overweight children to eat in response to internal appetite cues . METHOD Overweight children ( ages 6 - 12 years old ) were r and omized to either the CAAT treatment group ( N = 23 ) , to receive 1-h treatment sessions over 6 weeks , or a wait-list group ( N = 24 ) . Weight and height of children and parents in both groups were assessed at pre- and post-treatment ( or equivalent time for wait-list control ) and at a 6-month follow-up for those in the CAAT group . RESULTS The intervention had a significant , short-term effect on the BMI of children who participated . Although at 6-month follow-up , children 's BMI has not increased significantly , the difference between pretreatment and follow-up BMI was no longer significant . DISCUSSION These results are encouraging for the use of CAAT with overweight children . Long-term effectiveness could be enhanced through increasing the duration of the program , adding booster sessions and increased involvement of parents Objective : In general , treatment of childhood obesity focuses on treating the obese children . The results of child-directed treatments are disappointing in the long run . In the current study , it is tested whether a treatment aim ed solely at obese children 's parents results in positive effects on the children 's weight status . In addition , potential predictors of treatment success are identified . Methods : The parents of 98 overweight or obese children ( aged 7–13 years ) were r and omly assigned to either the cognitive-behavioural group treatment ( eight sessions ) or the waiting-list control group . Results : With respect to child body mass index ( BMI ) percentile , the parents ’ treatment was successful in reducing overweight from pretreatment to posttreatment : BMI percentile decreased significantly by 2.4 % in the treatment group , whereas there was no change in the waiting-list control group . There was no significant relapse at follow-up ( 3 months ) . Child BMI percentile did not decrease in the waiting-list control group . In addition , significant main effects of time were found for both groups with respect to eating psychopathology ( decrease ) , self-esteem ( increase ) and negative thoughts ( decrease ) . Finally , parental BMI decreased significantly only in the treatment group . Four predictors were identified with respect to treatment success , namely , lower socioeconomic status , younger age of the child , higher parental attendance and lower BMI percentile of the child before treatment . Conclusions : The parents ’ treatment had significant effects on child and parent BMI . Long-term endurance of these positive effects needs to be studied . Striking are the positive effects of time in the waiting-list control group for some psychological outcome measures . Obviously , waiting for treatment already affects psychological processes ( but not behaviour ) in the children IMPORTANCE Identifying community-based programs that increase physical activity among diverse youth could yield sustainable tools to reduce obesity and obesity disparities . OBJECTIVE To evaluate the impact of a community-based after-school soccer and youth development program , America SCORES , on students ' physical activity , weight status , and fitness . DESIGN Cluster-r and omized trial . Study measures were collected in the fall ( baseline ) , winter ( midpoint ) , and spring ( end point ) of the 2009 - 2010 school year . SETTING After-school programs in 6 schools within a large urban school district . PARTICIPANTS All 4th and 5th grade students in after-school programs at the study schools were eligible . INTERVENTION Three schools were r and omized to receive the SCORES after-school program , delivered via the train-the-trainer model . MAIN OUTCOME MEASURES Change in minutes of after-school moderate-to-vigorous physical activity ( MVPA ) , fitness ( maximal oxygen consumption ) , and body mass index over 1 school year . RESULTS Participants ( n = 156 ) were diverse ( 42 % Latino , 32 % Asian , and 12 % African American ) and 76 ( 49 % ) had a body mass index at or above the 85th percentile . There were no significant group differences in the change in physical activity , fitness , or weight status among all students . However , among students with a body mass index at or above the 85th percentile , SCORES significantly increased MVPA after school ( 3.4 min/d ; 95 % CI , 0.3 - 6.5 ) and on Saturdays ( 18.5 minutes ; 95 % CI , 3.4 - 33.6 ) . CONCLUSIONS AND RELEVANCE Existing community-based programs such as SCORES can increase physical activity among low-income youth , particularly those most at risk for weight-related comorbidities . While evaluating existing programs presents special challenges , partnerships between communities , schools , and research ers are an important component of translational research to address obesity . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01156103 BACKGROUND A common policy response to the childhood obesity epidemic is to recommend that primary care physicians screen for and offer counseling to the overweight/obese . As the literature suggests , this approach may be ineffective ; it is important to document the opportunity costs incurred by brief primary care obesity interventions that ultimately may not alter body mass index ( BMI ) trajectory . METHODS Live , Eat and Play ( LEAP ) was a r and omized controlled trial of a brief secondary prevention intervention delivered by family physicians in 2002 - 2003 that targeted overweight/mildly obese children aged 5 to 9 years . Primary care utilization was prospect ively audited via medical records , and parents reported family re source use by written question naire . Outcome measures were BMI ( primary ) and parent-reported physical activity and dietary habits ( secondary ) in intervention compared with control children . RESULTS The cost of LEAP per intervention family was AU $ 4094 greater than for control families , mainly due to increased family re sources devoted to child physical activity . Total health sector costs were AU $ 873 per intervention family and AU $ 64 per control , a difference of AU $ 809 ( P < .001 ) . At 15 months , intervention children did not differ significantly in adjusted BMI or daily physical activity scores compared with the control group , but dietary habits had improved . CONCLUSIONS This brief intervention result ed in higher costs to families and the health care sector , which could have been devoted to other uses that do create benefits to health and /or family well-being . This has implication s for countries such as the United States , the United Kingdom , and Australia , whose current guidelines recommend routine surveillance and counseling for high child BMI in the primary care sector Childhood obesity may be lessened by parent-focused interventions . A pilot parent-directed trial with 46 parents of overweight and obese elementary school students was conducted at two ethnically diverse public schools in Framingham , Massachusetts . Parents were r and omly assigned to either the Material s Group , which received mailed educational material s , or the Material s plus Personal Encounters Group , which received educational material s through interactions with community health workers ( CHWs ) . Parents completed baseline and post-intervention surveys ; children ’s body mass index ( BMI ) percentiles were measured at baseline and post-intervention . There were no differences in the reduction of children ’s BMI between groups . However , the mean BMI percentile for all children dropped from 94.1 to 90.6 ( p = .005 ) , while there was no change in BMI among a nonr and omized contemporaneous control group . Findings are limited by the lack of a true control group and small sample size . Results from this school nurse and CHW outreach program to parents are encouraging BACKGROUND The aim was to assess the feasibility and preliminary efficacy of a community-based physical activity ( PA ) intervention targeting mothers and daughters . METHODS A r and omized controlled trial of 48 primary school-aged girls and their 40 mothers were r and omized to ( i ) Mothers And Daughters Exercising for Life ( MADE4Life ) ( n = 21 mothers , n = 25 daughters ) or ( ii ) wait-list control ( n = 19 mothers , n = 23 daughters ) . The 8-week program involved 8 sessions ; 25-minute separate mothers and daughters education sessions and 60-minutes PA together . Assessment s were at baseline , postintervention and 3-month postintervention . Primary outcome measure was daughters ' moderate-to- vigorous physical activity ( MVPA ) ( accelerometer ) . Secondary outcomes included accelerometer-assessed light/moderate/vigorous PA , BMI , waist circumference , body composition , blood pressure , resting heart rate , sedentary behaviors and mothers ' self-reported PA , parenting measures , and cognitions . Intention-to-treat analysis used linear mixed models . RESULTS Recruitment and retention goals were exceeded . Attendance rates , program acceptability and satisfaction were high . There was no significant group-by-time effect for daughters ' % MVPA ( -0.08 ; 95%CI -1.49 , 1.33 , d = -0.03 ) or other secondary outcomes for girls ( postintervention range d = 0.01 to -0.46 ) . Significant intervention effects were found for mothers ' % VPA ( P = .04 , d = 0.25 ) and role modeling ( P = .02 , d = 0.66 ) . CONCLUSION MADE4Life was both feasible and acceptable . Although very small effect sizes were found for the daughters , significant changes were seen for mothers ( d = 0.25 to 0.66 ) . Future fully powered trials targeting PA in mothers and daughters is warranted OBJECTIVE : To test the feasibility , acceptability and preliminary impact of Parents and Tots Together ( PTT ) , a family-based obesity prevention intervention , in Canada . PARTICIPANTS : Canadian parents of preschoolers ( aged 2–5 years ) . SETTING : Ontario Early Years centres in southwestern Ontario . INTERVENTION : A pilot r and omized controlled trial involving 48 parents who received either the PTT intervention ( n = 27 ) or an attention-matched control home safety intervention ( n = 21 ) . To evaluate the feasibility of PTT , we assessed participant retention and outcome evaluation completion rates . To evaluate acceptability , we assessed program attendance and parents ’ responses to program satisfaction surveys . To evaluate preliminary impact , we assessed children ’s body mass index ( BMI ) at baseline , after intervention ( end of 9-week intervention ) and at 9-month follow-up . As well , at each time point , parents completed surveys assessing stress and self-efficacy related to parenting , children ’s sleep , activity , TV viewing and diet . OUTCOMES : Retention rates were high in the intervention ( 93 % ) and control ( 84 % ) study arms , and 87 % of parents reported that they would highly recommend PTT to a friend . At 9-month follow-up , intervention parents reported lower parenting stress β̂ = 15.83 , 95 % confidence interval [ CI ] −29.57 , −2.07 , p = 0.02 ) and greater self-efficacy in managing their child ’s behaviour ( β̂ = 0.16 , 95 % CI 0.002 , 0.33 , p = 0.05 ) than control parents . PTT had minimal influence on children ’s weight-related behaviours and BMI . CONCLUSIONS : The results suggest that PTT can feasibly be implemented and tested in the Canadian context . Preliminary impact results suggest that the program may be effective in changing general parenting ; however , program content should be modified to adequately address children ’s weight-related behaviours . RésuméOBJECTIF : Tester la faisabilité , l’acceptabilité et l’impact préliminaire de Parents and Tots Together ( PTT ) , une intervention de prévention de l’obésité menée auprès des familles au Canada . PARTICIPANTS : Des parents canadiens d’enfants d’âge préscolaire ( 2–5 ans).LIEU : Les Centres de la petite enfance du Sud-Ouest de l’Ontario . INTERVENTION : Un essai pilote comparatif r and omisé auprès de 48 parents ayant reçu soit l’intervention PTT ( n = 27 ) , soit une intervention-témoin sur la sécurité à domicile de même niveau d’attention ( n = 21 ) . Pour déterminer la faisabilité de PTT , nous avons évalué les taux de conservation des participants et leur taux de réponse aux question naires d’évaluation des résultats . Pour déterminer l’acceptabilité , nous avons évalué la fréquentation du programme et les réponses des parents aux sondages sur leur satisfaction par rapport au programme . Pour déterminer l’impact préliminaire , nous avons évalué l’indice de masse corporelle ( IMC ) des enfants au départ , après l’intervention ( au bout de 9 semaines ) et lors du suivi après 9 mois . De plus , à chaque étape , les parents ont rempli des question naires évaluant leur stress et leur autoefficacité liés à leur rôle parental et au sommeil , à l’activité , à l’écoute de la télévision et au régime des enfants . EFFETS : Les taux de conservation ont été élevés pour l’intervention ( 93 % ) et pour l’étude témoin ( 84 % ) , et 87 % des parents ont déclaré qu’ils recomm and eraient vivement le programme PTT à un ami . Au suivi après 9 mois , comparativement aux parents témoins , les parents de l’intervention ont fait état d’un stress moins élevé lié au rôle parental ( β̂ = 15,83 , intervalle de confiance [ IC ] de 95 % : −29,57 , −2,07 , p = 0,02 ) et d’une autoefficacité plus élevée dans la gestion du comportement de leur enfant ( β̂ = 0,16 , IC de 95 % : 0,002 , 0,33 , p = 0,05 ) . Le programme PTT n’a eu qu’une influence minime sur les comportements liés au poids et sur l’IMC des enfants . CONCLUSIONS : Les résultats montrent qu’il est faisable de mettre en œuvre et de tester le programme PTT dans le context e canadien . Les résultats sur l’impact préliminaire montrent que le programme peut être efficace pour changer les compétences parentales en général , mais qu’il faudrait en modifier le contenu pour aborder convenablement les comportements liés au poids chez les enfants The aim of this study was to evaluate the effectiveness of the Mind , Exercise , Nutrition , Do it ( MEND ) Program , a multicomponent community-based childhood obesity intervention ( www.mend central .org ) . One hundred and sixteen obese children ( BMI > or= 98 th percentile , UK 1990 reference data ) were r and omly assigned to intervention or waiting list control ( 6-month delayed intervention ) . Parents and children attended eighteen 2-h group educational and physical activity sessions held twice weekly in sports centers and schools , followed by a 12-week free family swimming pass . Waist circumference , BMI , body composition , physical activity level , sedentary activities , cardiovascular fitness , and self-esteem were assessed at baseline and at 6 months . Children were followed up 12 months from baseline ( 0 and 6 months postintervention for the control and intervention group , respectively ) . Participants in the intervention group had a reduced waist circumference z-score ( -0.37 ; P < 0.0001 ) and BMI z-score ( -0.24 ; P < 0.0001 ) at 6 months when compared to the controls . Significant between-group differences were also observed in cardiovascular fitness , physical activity , sedentary behaviors , and self-esteem . Mean attendance for the MEND Program was 86 % . At 12 months , children in the intervention group had reduced their waist and BMI z-scores by 0.47 ( P < 0.0001 ) and 0.23 ( P < 0.0001 ) , respectively , and benefits in cardiovascular fitness , physical activity levels , and self-esteem were sustained . High-attendance rates suggest that families found this intensive community-based intervention acceptable . Further larger controlled trials are currently underway to confirm the promising findings of this initial trial Objective : This r and omized controlled trial tested the efficacy of an internetbased lifestyle behavior modification program for weight management in African-American girls . Design : African-American girls were r and omly assigned to an interactive behavioral internet program or an internet health education program , the control condition . The behavioral intervention included internet counseling and was highly interactive . The control intervention was a passive ( non-interactive ) educational program . Parents were also participants in the study . Participants in both treatment groups met in face-to-face sessions on four occasions over the first 12 weeks of a 6-month intervention . Subjects : The study enrolled 57 African-American adolescent girls ( ages 11 to 15 years ) who were overweight or obese and had at least one biological parent who was obese [ body mass index ( BMI ) > 30 kg/m2 ] . Of the 57 participants , 50 ( 88 % ) completed the 6-month trial . Measurements : Outcome data , including BMI , body weight , body composition , dietary intake , and weight loss behaviors were collected at baseline and 6-months later . A computer server tracked utilization of the websites . Participation in the program was measured by number of “ hits ” on the website . Results : Compared to the control condition , adolescents in the behavioral treatment lost more body fat ( group difference = 1.6 % body fat ) and parents lost significantly more body weight ( group difference = 2.1 kg ) . Utilization of the behavioral website by adolescents and parents was associated with positive outcome . Dietary fat intake was lowered for adolescents and parents in the behavioral treatment group . Conclusion : An internet-based behavioral intervention was superior to internet-based health education and yielded decreased body fat for adolescent girls and decreased body weight for parents OBJECTIVE Go Girls was a church-based nutrition and physical activity program design ed for overweight African-American ( AA ) adolescent females . RESEARCH METHODS AND PROCEDURES Ten predominantly middle-socioeconomic churches were r and omized to either a high-intensity ( 20 to 26 sessions ) or moderate-intensity ( six sessions ) culturally tailored behavioral group intervention delivered over 6 months . Each session included an experiential behavioral activity , approximately 30 minutes of physical activity , and preparation and tasting of healthy foods . In the high-intensity group , girls also received four to six telephone counseling calls . From the 10 churches , 123 girls completed baseline and 6-month post-test assessment s. The primary outcome was BMI ; secondary outcomes included waist and hip circumferences , percentage body fat estimated by bioimpedance , serum insulin , glucose , and lipids , and cardiovascular fitness at 6-month follow-up . Selected measures were also collected at 1-year follow-up . RESULTS At 6-month follow-up , the net difference between the high- and moderate-intensity groups was 0.5 BMI units . This difference was not statistically significant ( p = 0.20 ) . There were no significant group differences in secondary outcomes . Girls in the high-intensity condition , however , who attended more than three-quarters of the sessions had significantly lower BMI and percentage body fat relative to girls in the high-intensity group who attended fewer sessions . Findings at 1-year follow-up mirrored those at 6 months . DISCUSSION We concluded that the intervention was not effective in reducing adiposity , although there were some positive findings among high attenders . Despite the null result , the intervention was generally well received by participants . Future interventions may require greater dose and a more structured dietary change program The aim of the present study was to compare the effects of a multidisciplinary approach ( MTG ) and aerobic interval training ( AIT ) on cardiovascular risk factors in overweight adolescents . A total of 62 overweight and obese adolescents from Trøndelag County in Norway , referred to medical treatment at St Olav 's Hospital , Trondheim , Norway , were invited to participate . Of these , 54 adolescents ( age , 14.0 + /- 0.3 years ) were r and omized to either AIT ( 4 x 4 min intervals at 90 % of maximal heart rate , each interval separated by 3 min at 70 % , twice a week for 3 months ) or to MTG ( exercise , dietary and psychological advice , twice a month for 12 months ) . Follow-up testing occurred at 3 and 12 months . VO(2max ) ( maximal oxygen uptake ) increased more after AIT compared with MTG , both at 3 months ( 11 compared with 0 % ; P<0.01 ) and 12 months ( 12 compared with -1 % ; P<0.01 ) . AIT enhanced endothelial function compared with MTG at both 3 months ( absolute change , 5.1 compared with 3.9 % ; P<0.01 ) and 12 months ( absolute change , 6.3 compared with 1.0 % ; P<0.01 ) . AIT was favourable compared with MTG in reducing BMI ( body mass index ) , percentage of fat , MAP ( mean arterial blood pressure ) and increasing peak oxygen pulse . In addition , AIT induced a more favourable regulation of blood glucose and insulin compared with MTG . In conclusion , the novel findings of the present proof-of-concept study was that 3 months of twice weekly high-intensity exercise sessions reduced several known cardiovascular risk factors in obese adolescents more than that observed after a multitreatment strategy , which was initiated as hospital treatment . Follow-up at 12 months confirmed that AIT improved or maintained these risk factors to a better degree than MTG Background . Primary care is an ideal setting to treat pediatric obesity . Effective , low-intensity ( ≤25 contact hours over 6 months ) interventions that reduce st and ardized body mass index ( z- BMI ) and can be delivered by primary care providers are needed . Objective . This pilot r and omized controlled trial investigated the effect of 3 low-intensity ( ≤25 contact hours over 6 months ) pediatric obesity treatments on z- BMI . Methods . Twenty-two families ( children 8.0 ± 1.8 years , z- BMI of 2.34 ± 0.48 ) were r and omized into 1 of 3 , 6-month , low-intensity conditions : newsletter ( N ) , newsletter and growth monitoring ( N + GM ) , or newsletter and growth monitoring plus family-based behavioral counseling ( N + GM + BC ) . Anthropometrics and child eating and leisure-time behaviors were measured . Results . Mixed-factor analyses of variance found a significant ( P < .05 ) main effect of time for z- BMI and servings per day of sugar sweetened beverages , with both decreasing over time . Conclusion . Low-intensity obesity treatments can reduce z- BMI and may be more feasible in primary care Objective : This longitudinal experimental study compared effects of self-efficacy , planning and education-based conditions , encouraging adolescents to eat fruit and vegetable in place of energy-dense foods . Design : Data were collected among 506 adolescents ( 13–18 years old ) who were r and omly assigned to control ( n = 181 ) , planning ( n = 153 ) or self-efficacy ( n = 172 ) conditions . Measurements were taken at baseline ( T1 ) , at a 2-month follow-up ( T2 ) , and at a 14-month follow-up ( T3 ) . Interventions /control group procedures were delivered at T1 and T2 . Outcome measures : Self-reports of fruit and vegetable intake ( FVI ) and energy-dense foods intake were collected at three times . Cognitive mediators ( self-efficacy and planning ) were assessed at T1 and T2 . Body weight and height were objective ly measured at T1 and T3 . Results and conclusions : Similar significant increases of FVI were found for planning and self-efficacy interventions ( T3 ) . The planning intervention did not influence energy-dense food intake ( T3 ) , but the self-efficacy intervention tended to result in stabilising intake ( compared to an increase found in the control group ) . There were no effects on body weight . Similar patterns were found for the total sample and for a sub sample of adolescents with overweight/obesity . The effects of interventions on FVI were mediated by respective cognitions OBJECTIVE The objective of this study was to examine the efficacy of U.S. primary care paediatric obesity treatment recommendations , within two r and omized trials . METHODS Between November 2005 to September 2007 , 182 families ( children aged 4 - 9 years , body mass index [ BMI ] ≥85th percentile ) were recruited for two separate trials and r and omized within trial to a 6-month intervention . Each trial had one intervention that increased child growth-monitoring frequency and feedback to families ( GROWTH MONITORING ) . Each trial also had two interventions , combining GROWTH MONITORING with an eight-session , behavioural , parent-only intervention targeting two energy-balance behaviours ( Trial 1 : reducing snack foods and sugar-sweetened beverages [ DECREASE ] , and increasing fruits , vegetables and low-fat dairy [ INCREASE ] ; Trial 2 : decreasing sugar-sweetened beverages and increasing physical activity [ TRADITIONAL ] and increasing low-fat milk consumption and reducing television watching [ SUBSTITUTES ] ) . Child st and ardized BMI ( Z BMI ) and energy intake were assessed at 0 , 6 and 12 months . RESULTS In both trials , main effects of time were found for Z BMI , which decreased at 6 and 12 months ( P < 0.01 ) . In Trial 1 , Z BMI reduced from 0 to 6 months , which was maintained from 6 to 12 months ( ΔZ BMI 0 to 12 months = -0.12 ± 0.22 ) . In Trial 2 , Z BMI reduced from 0 to 6 and from 6 to 12 months ( ΔZ BMI 0 - 12 months = -0.16 ± 0.31 ) . For energy intake , main effects of time were found in both trials and intake reduced from 0 to 6 months ( P < 0.05 ) , with Trial 1 reducing intake from 0 to 12 months ( P < 0.05 ) . CONCLUSIONS All interventions improved weight status . Future research should examine effectiveness and translatability of these approaches into primary care setting This paper describes the development , implementation and evaluation of a school- and family-based intervention to prevent obesity in children aged 5 - 7 years . In addition , the efficacy of three different intervention programmes was compared . Children aged 5 - 7 years ( n=213 ) were recruited from three primary schools in Oxford and r and omly allocated to a control group or one of three intervention groups : nutrition group , physical activity group , and combined nutrition and physical activity group . The setting for the interventions was lunchtime clubs , where an interactive and age-appropriate nutrition and /or physical activity curriculum was delivered . The intervention lasted for 20 weeks over four school terms ( approximately 14 months ) . Children 's growth , nutrition knowledge , diet and physical activity were assessed at baseline and at the end of the intervention . Significant improvements in nutrition knowledge were seen in all children ( p<0.01 ) between baseline and post-intervention , and results were highly significant in the nutrition and combined group ( p<0.001 ) . Overall , fruit and vegetable intake increased significantly ( p<0.01 and < 0.05 , respectively ) , with changes seen in fruit consumption in the nutrition group ( p<0.05 ) and the control group ( p<0.05 ) in particular . No significant changes in the rates of overweight and obesity were seen as a result of the intervention . Gender differences were not detected in the majority of assessment s and there was no clear effect of programme type per se . This pilot study has demonstrated that school may be a suitable setting for the promotion of healthy lifestyles in children , but requires replication in other social setting s. Future initiatives should be long-lasting , multi-faceted and sustainable , involving all children in a school , and should target the whole environment and be behaviourally focused . The ultimate goal of any such programme is to lead to positive behaviour change which will have a beneficial effect on long-term health . Successful targeting of the family remains a challenge to such interventions OBJECTIVES : The objective of this study was to evaluate a 12-session home/community-based health promotion/obesity prevention program ( Challenge ! ) on changes in BMI status , body composition , physical activity , and diet . METHODS : A total of 235 black adolescents ( aged 11–16 years ; 38 % overweight/obese ) were recruited from low-income urban communities . Baseline measures included weight , height , body composition , physical activity ( PA ) , and diet . PA was measured by 7-day play-equivalent physical activity ( ≥1800 activity counts per minute ) . Participants were r and omly assigned to health promotion/obesity prevention that is anchored in social cognitive theory and motivational interviewing and was delivered by college-aged black mentors or to control . Postintervention ( 11 months ) and delayed follow-up ( 24 months ) evaluations were conducted . Longitudinal analyses used multilevel models with r and om intercepts and generalized estimating equations , controlling for baseline age/gender . Stratified analyses examined baseline BMI category . RESULTS : Retention was 76 % over 2 years ; overweight/obese status declined 5 % among intervention adolescents and increased 11 % among control adolescents . Among overweight/obese youth , the intervention reduced total percentage of body fat and fat mass and increased fat-free mass at delayed follow-up and increased play-equivalent physical activity at postintervention but not at delayed follow-up . Intervention adolescents declined significantly more in snack/dessert consumption than control adolescents at both follow-up evaluations . CONCLUSIONS : At postintervention , there were intervention effects on diet and PA but not BMI category or body composition . At delayed follow-up , dietary changes were sustained and the intervention prevented an increase in BMI category . Body composition was improved for overweight/obese youth . Changes in body composition follow changes in diet and PA and may not be detected immediately after intervention This study investigated the effectiveness of cognitive self-management training as an adjunct to the behavioural management of childhood obesity . Twenty-seven overweight children aged 7 - 13 years were r and omly assigned to either behavioural management plus relaxation placebo or a combined behavioural-cognitive self-management approach . Evaluations following the eight treatment sessions revealed a significant reduction in percentage overweight for children in both experimental groups and improvements were maintained at 3- and 6-month follow-ups . Both conditions were also effective in reducing the number of high-risk foods consumed . No difference in outcome was found between treatments at the post-treatment assessment or 3- and 6-month follow-ups . Although a reduction in percentage overweight of around 9 % was found for both procedures , subjects in general remained considerably overweight Obesity prevalence is increasing in the U.S. , especially among children and minority population s. This report describes the design and baseline data of the ongoing Girls health Enrichment Multi-site Studies ( GEMS ) trial ( Memphis site ) , which is testing the efficacy of a 2-year family-based intervention to reduce excessive increase in body mass index ( BMI ) . This r and omized , controlled trial conducted at community centers in Memphis , Tennessee requires major measurements at baseline and at 12 and 24 months post-r and omization . The participants are healthy African-American girls and one parent/caregiver of each girl . Participating girls are of ages 8 - 10 years , with BMI > or=25th percentile of the CDC 2000 growth charts or with one overweight or obese parent/caregiver ( BMI > or=25 kg/m(2 ) ) . The active intervention is design ed to prevent excessive weight gain by promoting healthy eating habits and increasing physical activity . An alternative intervention ( comparison group ) promotes general self-esteem and social efficacy . The main outcome measure is the difference between the two treatment groups in the change in BMI at 2 years . Three hundred and three girls have been r and omly assigned to receive the test intervention ( n=153 ) or the alternative intervention ( n=150 ) . The two groups do not differ in baseline characteristics . At the time of enrollment , the mean age was 9 years , the mean BMI was 22 kg/m(2 ) ( mean BMI percentile=77 th ) , and 41 % were overweight ( BMI > /=95th percentile using CDC 2000 growth charts ) . Participants ' intake of fruits and vegetables ( 1.3 serving/day ) and fats ( 36 % kcal ) , and their participation in moderate-to-vigorous physical activity ( 20 min/day ) , did not meet national recommendations . The GEMS obesity prevention intervention targets improved diet and increased physical activity to reduce excessive weight gain in healthy African-American girls of ages 8 - 10 The purpose of this study was to compare the effectiveness of three smoking cessation programs of varying intensity applied in a primary care setting . Participants were 89 individuals r and omly assigned to one of three treatment groups : brief counseling plus information pamphlet , self-help program with telephone follow-up , and intensive behavioral treatment . At the 12-mo . follow-up , intensive behavioral treatment ( 42.8 % abstinence ) was more effective than the self-help program ( 27.5 % ) , which was in turn more effective than counseling ( 12.9 % ) . Continued abstinence was also higher in the intensive treatment group ( 37.9 % ) than in the self-help ( 17.2 % ) and the counseling groups ( 9.7 % ) , although these differences only reached statistical significance in the first and third of these groups . Treatment adherence was higher in the intensive behavioral group ( 82.8 % of participants atended all the sessions ) than in the self-help group ( 61.8 % completed the program ) . The results appear to confirm a dose-response effect in the treatment of smokers and indicate satisfactory acceptability of intensive behavioral programs applied in primary care BACKGROUND The Healthy Homes/Healthy Kids Preschool ( HHHK-Preschool ) pilot program is an obesity prevention intervention integrating pediatric care provider counseling and a phone-based program to prevent unhealthy weight gain among 2- to 4-year-old children at risk for obesity ( BMI percentile between the 50th and 85th percentile and at least one overweight parent ) or currently overweight ( 85th percentile ≤ BMI < 95th percentile ) . The aim of this r and omized , controlled pilot study was to evaluate the feasibility , acceptability , and potential efficacy of the HHHK-Preschool intervention . METHODS Sixty parent-child dyads recruited from pediatric primary care clinics were r and omized to : ( 1 ) the Busy Bodies/Better Bites Obesity Prevention Arm or the ( 2 ) Healthy Tots/Safe Spots safety/injury prevention Contact Control Arm . Baseline and 6-month data were collected , including measured height and weight , accelerometry , previous day dietary recalls , and parent surveys . Intervention process data ( e.g. , call completion ) were also collected . RESULTS High intervention completion and satisfaction rates were observed . Although a statistically significant time by treatment interaction was not observed for BMI percentile or BMI z-score , post-hoc examination of baseline weight status as a moderator of treatment outcome showed that the Busy Bodies/Better Bites obesity prevention intervention appeared to be effective among children who were in the overweight category at baseline relative to those who were categorized as at risk for obesity ( p = 0.04 ) . CONCLUSIONS HHHK-Preschool pilot study results support the feasibility , acceptability , and potential efficacy in already overweight children of a pediatric primary care-based obesity prevention intervention integrating brief provider counseling and parent-targeted phone coaching . What 's New : Implementing pediatric primary care-based obesity interventions is challenging . Previous interventions have primarily involved in-person sessions , a barrier to sustained parent involvement . HHHK-preschool pilot study results suggest that integrating brief provider counseling and parent-targeted phone coaching is a promising approach ABSTRACT A r and omized control trial of a group-based behavioral weight management program targeting parent and child health change using a diverse community sample was conducted . Children and parents were r and omized to an immediate treatment or waitlist condition and completed pre- and post-intervention measures of parent Body Mass Index ( BMI ) , child BMI z-score , child diet , and child physical activity . Families attending the treatment condition did not show greater improvements in outcomes . Child age and number of treatment sessions attended did not relate to health outcomes Family variables such as cohesion and nurturance have been associated with adolescent weight-related health behaviors . Integrating family variables that improve family functioning into traditional weight-loss programs can provide health-related benefits . The current study evaluated a family-based psychoeducational and behavioral skill-building weight-loss program for adolescent girls that integrated Family Systems and Social Cognitive Theories . Forty-two overweight ( > or = 95th percentile ) female adolescent participants and parents participated in a 16-week r and omized controlled trial comparing three groups : multifamily therapy plus psychoeducation ( n=15 ) , psychoeducation-only ( n=16 ) , or wait list ( control ; n=11 ) group . Body mass index , energy intake , and family measures were assessed at baseline and posttreatment . Adolescents in the psychoeducation-only group demonstrated a greater decrease in energy intake compared to the multifamily therapy plus psychoeducation and control groups ( P<0.01 ) . Positive changes in family nurturance were associated with lower levels of adolescent energy intake ( P<0.05 ) . No significant effects were found for body mass index . Results provide preliminary support for a psychoeducational program that integrates family variables to reduce energy intake in overweight adolescent girls . Results indicate that nurturance can be an important family variable to target in future adolescent weight-loss and dietary programs STUDY OBJECTIVE To evaluate the effect of family therapy on childhood obesity . DESIGN Clinical trial . One year follow-up . SETTING Referral from school after screening . PARTICIPANTS Of 1774 children ( aged 10 to 11 ) , screened for obesity , 44 obese children were divided into two treatment groups . In an untreated control group of 50 obese children , screened in the same manner , body mass index ( BMI ) values were recorded twice , at 10 to 11 and at 14 years of age . INTERVENTION Both treatment groups received comparable dietary counseling and medical checkups for a period of 14 to 18 months , while one of the groups also received family therapy . RESULTS At the 1-year follow-up , when the children were 14 years of age , intention-to-treat analyses were made of the weight and height data for 39 of 44 children in the two treatment groups and for 48 of the 50 control children . The increase of BMI in the family therapy group was less than in the conventional treatment group at the end of treatment , and less than in the control group ( P = .04 and P = .02 , respectively ) . Moreover , mean BMI was significantly lower in the family therapy group than in the control group ( P < .05 ) , and the family therapy group also had fewer children with BMI > 30 than the control group ( P = .02 ) . The reduction of triceps , subscapular , and suprailiac skinfold thicknesses , expressed as percentages of the initial values , was significantly greater in the family therapy group than in the conventional treatment group ( P = .03 , P = .005 and P = .002 , respectively ) , and their physical fitness was significantly better ( P < .05 ) . CONCLUSIONS Family therapy seems to be effective in preventing progression to severe obesity during adolescence if the treatment starts at 10 to 11 years of age PURPOSE The number of youth that meet activity guidelines is decreasing and easy access to reinforcing sedentary behaviors competes with increasing physical activity . In the laboratory , open-loop feedback that used pedometer activity counts to gain access to sedentary alternatives doubled physical activity . This study evaluated the influence of open-loop feedback and reinforcement on physical activity and television ( TV ) time in a small clinical trial . METHODS Children ( 8 - 12 yr old ) were r and omized to an open-loop feedback plus reinforcement intervention ( N = 11 ) or no feedback , no reinforcement control ( N = 7 ) . Subjects wore an accelerometer for 6 wk and attended meetings to download the accelerometer . Accumulating physical activity counts gave subjects in the open-loop group access to TV time , controlled by a TV Allowance device , with 400 counts = 1 h of TV . The control group had no feedback for activity and free access to TV . RESULTS The open-loop group had a 24 % increase in physical activity , which was greater ( P = 0.02 ) than the control group . TV time of the open-loop group was reduced by 18 % or 20 min x d(-1 ) whereas the control group increased by 13 min x d(-1 ) , but these were not significant changes . The change in time spent watching television was directly related to the change in BMI z-score ( r = 0.69 , P = 0.002 ) . CONCLUSION Open-loop feedback increases physical activity in children , thus helping children to achieve physical activity recommendations . Reductions in TV watching may reduce or minimize gains in body weight OBJECTIVE There is a critical need for culturally relevant interventions to address obesity among Latino children , who have a greater risk of obesity and diabetes than non-Hispanic white children . To test the impact of a family-centered , culturally tailored obesity intervention delivered through group medical appointments on body mass index ( BMI ) and other measures of cardiovascular risk among Latino children . METHODS In a r and omized controlled trial , 55 parent-child dyads were assigned to Active and Healthy Families ( AHF ) or a usual care wait-list control condition . Dyads were eligible if they spoke Spanish and if the child received care in a federally qualified health center , was aged 5 to 12 years , had a BMI in the 85th percentile or higher , and had not participated in AHF . The 10-week AHF intervention included biweekly group sessions delivered by a registered dietitian , physician , and promotora triad . Sessions covered topics such as parenting , screen time , healthy beverages , physical activity , and stress due to immigration . RESULTS Child BMI ( kg/m(2 ) ) decreased ( -0.50 ) in the AHF group and increased ( + 0.32 ) in the control group , yielding an adjusted difference in change of -0.78 ( 95 % confidence interval [ CI ] -1.28 , -0.27 ) . Children assigned to AHF also exhibited relative improvements over controls in BMI z score ( -0.10 ; 95 % CI -0.19 , -0.02 ) and triglycerides ( -26.8 mg/dL ; 95 % CI -50.1 , -3.6 ) , but no significant between-group differences were observed for blood pressure or other fasting blood measures . CONCLUSIONS AHF result ed in reductions in child BMI , BMI z score , and triglycerides . AHF , which was design ed for low-income Latino families , has potential to reduce health disparities , but future studies are needed to determine long-term impact Obese children 8 - 12 years old from 61 families were r and omized to treatment groups that targeted increased exercise , decreased sedentary behaviors , or both ( combined group ) to test the influence of reinforcing children to be more active or less sedentary on child weight change . Significant decreases in percentage overweight were observed after 4 months between the sedentary and the exercise groups ( -19.9 vs. -13.2 ) . At 1 year , the sedentary group had a greater decrease in percentage overweight than did the combined and the exercise groups ( -18.7 vs. -10.3 and -8.7 ) and greater decrease in percentage of body fat ( -4.7 vs. -1.3 ) . All groups improved fitness during treatment and follow-up . Children in the sedentary group increased their liking for high-intensity activity and reported lower caloric intake than did children in the exercise group . These results support the goal of reducing time spent in sedentary activities to improve weight loss OBJECTIVE : To investigate the effect of protein and glycemic index ( GI ) on body composition among European children in the r and omized , 6-month dietary intervention DiOGenes ( diet , obesity , and genes ) family-based study . PATIENTS AND METHODS : In the study , 827 children ( 381 boys and 446 girls ) , aged 5 to 18 years , completed baseline examinations . Families with parents who lost ≥8 % of their weight during an 8-week run-in low-calorie diet period were r and omly assigned to 1 of 5 ad libitum diets : low protein (LP)/low glycemic index ( LGI ) ; LP/high GI ( HGI ) ; high protein (HP)/LGI ; HP/HGI ; and control diet . The target difference was 15 GI U between the LGI/HGI groups and 13 protein percentage points between the LP/HP groups . There were 658 children examined after 4 weeks . Advice on food-choice modification was provided at 6 visits during this period . No advice on weight loss was provided because the focus of the study was the ability of the diets to affect outcomes through appetite regulation . Anthropometric measurements and body composition were assessed at baseline , week 4 , and week 26 . RESULTS : In the study , 465 children ( 58.1 % ) completed all assessment s. The achieved differences between the GI and protein groups were 2.3 GI U and 4.9 protein percentage points , respectively . The LP/HGI group increased body fat percentage significantly more than the other groups ( P = .040 ; partial η2 = 0.039 ) , and the percentage of overweight/obese children in the HP/LGI group decreased significantly during the intervention ( P = .031 ) . CONCLUSIONS : Neither GI nor protein had an isolated effect on body composition . However , the LP/HGI combination increased body fat , whereas the HP/LGI combination was protective against obesity in this sample of children Obese children were r and omly assigned to a family-based behavioral treatment that included either stimulus control or reinforcement to reduce sedentary behaviors . Significant and equivalent decreases in sedentary behavior and high energy density foods , increases in physical activity and fruits and vegetables , and decreases in st and ardized body mass index ( z- BMI ) were observed . Children who substituted active for sedentary behaviors had significantly greater z- BMI changes at 6 ( -1.21 vs. -0.76 ) and 12 ( -1.05 vs. -0.51 ) months , respectively . Substitution of physically active for sedentary behaviors and changes in activity level predicted 6- and 12-month z- BMI changes . Results suggest stimulus control and reinforcing reduced sedentary behaviors are equivalent ways to decrease sedentary behaviors , and behavioral economic relationships in eating and activity may mediate the effects of treatment OBJECTIVE To assess the extent to which an obesity prevention intervention that embeds obesity-related messages within a parenting program , compared with controls who received weekly mailings , result ed in a smaller increase in children 's BMI ( primary outcome ) and improvements in weight-related behaviors from baseline to 9-month follow-up . METHODS Fifty-six families were r and omly assigned to the intervention and 56 to control . Children were primarily Hispanic ( 58 % ) or Black/African American ( 23 % ) . Intervention included nine weekly : group parenting sessions , children 's sessions , and homework assignments . At baseline , post-intervention , and 9-month follow-up , staff assessed children 's weight and height . Parents completed surveys assessing parenting skills , feeding behaviors , and children 's weight-related behaviors . RESULTS From baseline to 9-month follow-up , BMI decreased by a mean of 0.13 kg m(-2 ) among children in the intervention and increased by 0.21 kg m(-2 ) among children in the control , result ing in a nonsignificant difference ( multivariate adjusted difference = -0.36 ; 95 % confidence interval [ CI ] -1.23 , 0.51 ; P = 0.41 ) . Parents in the intervention decreased restrictive feeding practice s relative to control ( -0.30 ; 95 % CI -0.53 , -0.07 ; P = 0.01 ) . Intervention and control arms showed similar changes in children 's weight-related behaviors . CONCLUSIONS The intervention improved restrictive feeding but did not influence children 's BMI or weight-related behaviors compared to controls who received weekly mailings CONTEXT Few r and omized controlled trials ( RCTs ) of interventions for the treatment of childhood obesity have taken place outside the Western world . AIM To test whether a good practice intervention for the treatment of childhood obesity would have a greater impact on weight status and other outcomes than a control condition in Kuala Lumpur , Malaysia . METHODS Assessor-blinded RCT of a treatment intervention in 107 obese 7- to 11-year olds . The intervention was relatively low intensity ( 8 hours contact over 26 weeks , group based ) , aim ing to change child sedentary behavior , physical activity , and diet using behavior change counselling . Outcomes were measured at baseline and six months after the start of the intervention . Primary outcome was BMI z-score , other outcomes were weight change , health-related quality of life ( Peds QL ) , objective ly measured physical activity and sedentary behavior ( Actigraph accelerometry over 5 days ) . RESULTS The intervention had no significant effect on BMI z score relative to control . Weight gain was reduced significantly in the intervention group compared to the control group ( + 1.5 kg vs. + 3.5 kg , respectively , t-test p < 0.01 ) . Changes in health-related quality of life and objective ly measured physical activity and sedentary behavior favored the intervention group . CONCLUSIONS Treatment was associated with reduced rate of weight gain , and improvements in physical activity and quality of life . More substantial benefits may require longer term and more intensive interventions which aim for more substantive lifestyle changes UNLABELLED What is already known about this subject Approximately one-fifth of children in the UK are obese . There are currently few , effective interventions available in the UK . There are very little data on relative cost-effectiveness of childhood obesity interventions , which hampers the commissioning of future services . What this study adds Simple multi-component obesity interventions can be provided at relatively low cost per 0.1 body mass index st and ard deviation score ( BMI SDS ) improvement . More intensive and effective interventions incur greater cost per 0.1 BMI SDS reduction but this may be justified given the improved overall BMI SDS reduction attained . OBJECTIVE To describe the costs and outcomes of three models of care for childhood obesity previously evaluated in two 2-arm pilot r and omized trials in Engl and . The treatments were ( i ) a hospital clinic ( control in both trials ) , comprising a multidisciplinary team of consultant , dietitian and exercise specialist ; ( ii ) a nurse-led primary care clinic replicating the service provided by the hospital and ( iii ) an intensive intervention using M and ometer ® , a behaviour modification tool aim ed at encouraging slower eating and better recognition of satiety . METHOD Patient-level data on re sources used to deliver each intervention were collected during the trials . Apart from the cost of the M and ometer ® the majority of cost was staff time , dependent on discipline and grade . Outcome for both trials was body mass index st and ard deviation score ( BMI SDS ) measured at 12 months . RESULTS Cost and outcome data were available for 143 children in total . Cost per child was £ 1749 ( SD £ 243 ) in the M and ometer ® group , £ 301 ( £ 76 ) in the primary care group , and £ 263 ( £ 88 ) and £ 209 ( £ 81 ) in the hospital groups . Mean reduction in BMI SDS was 0.40 ( 0.35 ) , 0.17 ( 0.26 ) , 0.15 ( 0.25 ) and 0.14 ( 0.32 ) , respectively . CONCLUSION Intensive management using M and ometer ® was effective but costly ( £ 432 per 0.1 reduction in BMI SDS ) compared to conventional care ( range £ 153-£173 ) . A total of 26 % children receiving conventional care achieved a clinical ly meaningful reduction in BMI SDS ; however , use of M and ometer ® training may be justified in children not responding to conventional lifestyle interventions OBJECTIVE Interpersonal psychotherapy ( IPT ) is effective at reducing binge episodes and inducing weight stabilization in obese adults with binge eating disorder . METHOD We piloted the administration of IPT to girls at-risk for excess weight gain ( BMI 75th-97th percentile ; IPT-WG ) with and without loss of control ( LOC ) eating . Thirty-eight girls ( 12 - 17 years ) were r and omized to IPT-WG or a st and ard-of-care health education group . RESULTS All 38 girls completed the programs and all follow-up visits through 6 months . Thirty-five of 38 returned for a complete assessment visit at 1 year . Among girls with baseline LOC ( n = 20 ) , those in IPT-WG experienced greater reductions in such episodes than girls in health education ( p = .036 ) . Regardless of LOC status , over 1 year girls in IPT-WG were less likely to increase their BMI as expected for their age and BMI percentile ( p = .028 ) . DISCUSSION IPT-WG is feasible and acceptable to adolescent girls at-risk for adult obesity and may prevent excess weight gain over 1 year OBJECTIVE The authors performed a group-based program for obese children and adolescents in Bavaria , Germany to enable them to establish a health-oriented lifestyle and to reduce overweight . The authors compared this program with a control approach based on the patients ' own initiative . DESIGN This is a controlled clinical trial . SETTING A nutrition program for out patients in a German university hospital . PARTICIPANTS Seventy-three obese patients aged 7 to 15 years ( mean 11.2 years ) were recruited by pediatricians and local newspaper reports and r and omized into intervention and control groups . Children and adolescents in each group were divided into 3 groups according to age--7 - 8 years , 9 - 10 years , and 11 - 13 years . Children were classified overweight ( defined as body mass index ( BMI ) > 90th percentile for age and gender ) , obese ( BMI > 97th percentile ) , and extremely obese ( BMI > 99.5th percentile ) , according to the European Childhood Obesity Group and the German Working Group on Pediatric Obesity , congruent with adult st and ards used to assess overweight and obesity . INTERVENTION Thirty-seven patients ( age 7 - 13 years , mean 10.9 years ) for the 1-year intervention . This intervention consisted of modules for physical activity , nutritional education , and coping strategies . The program was performed twice each week and incorporated parental participation and medical supervision , including laboratory tests . The obese controls ( n = 36 , age 8 - 15 years , mean 11.6 years ) received written therapeutic advice during a visit at 0 and 6 months in the outpatient clinic . MAIN OUTCOME MEASURE The primary outcome variable was the body mass index ( BMI ) z score . ANALYSIS Analysis of variance and t test were used , and a P value < .05 was considered significant . RESULTS There was a reduction of BMI z score in the active treatment group ( P < .05 ) , but not for controls . Moreover , the active group showed beneficial effects for body mass index ( BMI ) , fat mass , and systolic blood pressure 12 months after beginning the intervention . CONCLUSIONS AND IMPLICATION S Group-based programs for young , obese patients can be effective tools for establishing a health-oriented lifestyle and reducing the burden of obesity OBJECTIVE The purpose of the current study is to describe the development , implementation , and success of recruitment and adherence strategies of 303 African American preadolescent girls and their primary caregiver in the Girls health Enrichment Multi-site Studies ( GEMS ) program . METHODS A socio-ecologic model was used to guide selection and implementation of recruitment and retention strategies which were continuously monitored and revised in response . Strategy mode and frequency associated with program enrollment , engagement , and retention were analyzed . RESULTS Successful recruitment approaches included radio messages ( 23.1 % ) , school fliers ( 20.1 % ) , and friend referral ( 15 % ) . Initially 463 potential participants responded , 320 girls were screened , and 303 enrolled . Significant increases in participant accrual were observed between Wave 4 ( n=28 ) and Wave 5 ( n=91 ) after using a team recruitment approach . Implementing case management strategies and providing make-up sessions also served to keep participants current and engaged in the program . In year 2 , community field trips replaced the more structured sessions providing participants with experiential learning opportunities . Overall intervention attendance rates ranged from 79.7 % to 90.5 % among waves . Further , 75.9 % and 80.2 % , respectively , of participants attended 1-year and 2-year follow-ups . CONCLUSION Multiple recruitment strategies and flexible , responsive approaches to recruitment and retention guided by the socio-ecologic model facilitated optimal implementation of an intervention for preadolescent girls . Through the application of the socio-ecologic model research ers and program leaders will be able to identify strategies to enhance the probability of successful outcomes BACKGROUND . Parenting-skills training may be an effective age-appropriate child behavior-modification strategy to assist parents in addressing childhood overweight . OBJECTIVE . Our goal was to evaluate the relative effectiveness of parenting-skills training as a key strategy for the treatment of overweight children . DESIGN . The design consisted of an assessor-blinded , r and omized , controlled trial involving 111 ( 64 % female ) overweight , prepubertal children 6 to 9 years of age r and omly assigned to parenting-skills training plus intensive lifestyle education , parenting-skills training alone , or a 12-month wait-listed control . Height , BMI , and waist-circumference z score and metabolic profile were assessed at baseline , 6 months , and 12 months ( intention to treat ) . RESULTS . After 12 months , the BMI z score was reduced by ∼10 % with parenting-skills training plus intensive lifestyle education versus ∼5 % with parenting-skills training alone or wait-listing for intervention . Waist-circumference z score fell over 12 months in both intervention groups but not in the control group . There was a significant gender effect , with greater reduction in BMI and waist-circumference z scores in boys compared with girls . CONCLUSION . Parenting-skills training combined with promoting a healthy family lifestyle may be an effective approach to weight management in prepubertal children , particularly boys . Future studies should be powered to allow gender sub analysis This study r and omized obese children from 67 families to groups that received a 6-month family-based behavioral weight-control program plus parent and child problem solving , child problem solving , or st and ard treatment with no additional problem solving . The st and ard group showed larger body mass index ( BMI ) decreases than the parent + child group through 2 years , with significant differences in the percentage of children who showed large BMI changes . Significant statistical and clinical improvements were observed over time in child behavior problems and parental distress . Parent problem solving increased in the parent + child condition relative to the other conditions , whereas child problem solving increased equally in all conditions . The bulk of evidence suggests that problem solving did not add to treatment effectiveness beyond the st and ard family-based treatment BACKGROUND The origins of childhood obesity invariably need to be looked at within a family context and several review s have concluded in favour of parental involvement in the treatment of paediatric obesity . However , there is little consensus on the format , and next to weight outcomes behavioural outcomes also merit more attention when assessing program effectiveness . METHOD In this pilot study , a total of 50 families with overweight children ( aged 6 - 12 ) were r and omly allocated to a parent-led intervention group ( cognitive behavioural training ) or to a waiting list control group ( Study 1 ) . Afterwards , the parents of the waitlist control group also followed the intervention . All children were included in a follow-up study and were compared with a reference group ( Study 2 ) . RESULTS The intervention group as well as the waitlist group ( who had not yet received treatment ) showed a decrease in adjusted BMI over a 6-month period , although the decrease was only significant for the intervention group ( Study 1 ) . All children showed a decrease of 7 % in adjusted BMI from pre to one-year follow-up measurement ( Study 2 ) , while the reference group showed an increase in adjusted BMI over that period . Parents reported significant positive changes in children 's eating behaviour and a significant positive increase in familial health principles . CONCLUSIONS Weight and behavioural outcomes suggest potential for intervention effectiveness . Long-term follow-up is needed to reveal residual benefits of enhanced parenting skills on environmental lifestyle changes OBJECTIVES To assess the outcomes of the Loozit adolescent weight management intervention and to evaluate the effect of additional therapeutic contact 12 months into the program . DESIGN A 24-month , 2-arm r and omized controlled trial . Results at 12 months are presented . SETTING Community health center and children 's hospital in Sydney , Australia . PARTICIPANTS A total of 151 overweight or obese 13- to 16-year-olds . INTERVENTION In the first 2 months ( phase 1 ) , participants received 7 adolescent and parent weekly sessions focused on lifestyle modification . From 2 to 24 months ( phase 2 ) , adolescents attended booster sessions once every 3 months . During phase 2 , adolescents r and omized to the additional therapeutic contact arm also received telephone coaching and electronic communications once every 2 weeks . OUTCOME MEASURES Baseline to 12-month changes in body mass index z score and waist to height ratio ( primary outcomes ) and changes in metabolic , psychosocial , and behavioral variables . RESULTS Of 151 r and omized adolescents , 82.1 % completed 12-month follow-up . Intent-to-treat analyses showed significant reductions in mean body mass index z score ( -0.09 ; 95 % CI , -0.12 to -0.06 ) , waist to height ratio ( -0.02 ; 95 % CI , -0.03 to -0.01 ) , total cholesterol level ( -4 mg/dL ; 95 % CI , -8 to 0 mg/dL ; to convert to millimoles per liter , multiply by 0.0259 ) , and triglycerides level ( geometric mean , -80 mg/dL ; 95 % CI , -88 to -71 mg/dL ; to convert to millimoles per liter , multiply by 0.0113 ) . Most psychosocial outcomes improved , including global self-worth , but there were few dietary , physical activity , or sedentary behavior changes . No difference was found in primary outcomes between participants who did or did not receive additional therapeutic contact . CONCLUSIONS The Loozit r and omized controlled trial produced a significant but modest reduction in body mass index z score and improved psychosocial outcomes at 12 months . Supplementary telephone and electronic contact provided no additional benefit at 12 months . Trial Registration anzctr.org.au Identifier : 12606000175572 OBJECTIVE To describe the impact of a parent-led , family-focused child weight management program on the food intake and activity patterns of pre-pubertal children . METHODS An assessor-blinded , r and omized controlled trial involving 111 ( 64 % female ) overweight , pre-pubertal children 6 - 9 years of age r and omly assigned to parenting-skills training plus intensive diet and activity education ( P + DA ) , parenting-skills training alone ( P ) , or a 12-month wait-listed control ( WLC ) . Study outcomes were assessed at baseline , 6 months , and 12 months . This paper presents data on food intake assessed via a vali date d 54-item parent-completed dietary question naire and activity behaviours assessed via a parent-report 20-item activity question naire . RESULTS Intake of energy-dense nutrient-poor foods was lower in both intervention groups at 6 months ( mean difference , P + DA - 1.5 serves [ CI - 2.0 ; -1.0 ] ; P - 1.0 serves [ -2.0 ; -0.5 ] ) and 12 months ( mean difference P + DA - 1.0 serves [ CI - 2.0 ; -0.5 ] ; P - 1.0 serves [ - 1.5 ; 0.0 ] ) compared to baseline . Intake of vegetables , fruit , breads and cereals , meat and alternatives and dairy foods remained unchanged . Regardless of study group there were significant reductions over time in the reported time spent engaged in small screen activities and an increase in the time reported spent in active play . CONCLUSION A child weight management intervention that promotes food intake in line with national dietary guidelines achieves a reduction in children 's intake of energy-dense , nutrient-poor foods . This was achieved without compromising intake of nutrient-rich food and changes were maintained even once the intervention ceased OBJECTIVES : Childhood obesity interventions should be family-centered and focused on lifestyle behaviours that achieve sustainable reductions in adiposity . The primary objective of this r and omized controlled trial was to test a family-centered lifestyle intervention using Canada ’s Food and Physical Activity ( PA ) Guidelines to reduce body mass index-for-age z-scores ( BAZ ) in overweight and obese ( OW/OB ) children . METHODS : Children ( n = 78 ; ages 6–8.5 years ) were r and omized to st and ard ( StnTx ) or modified ( ModTx ) interventions or control ( Ctrl ) . Measurements at baseline and every three months for one year included : anthropometry , BAZ , waist circumference ( WC ) , and dual-energy X-ray absorptiometry scans for percent body fat ( % BF ) , fat mass ( FM ) and trunk fat mass . Fatty acids measured by gas chromatography were used to assess compliance to the milk and alternatives interventions during the first six months . Six intervention sessions were based on Canada ’s Food and PA Guidelines and individualized to meet the needs of the family . ModTx were advised to consume four milk and alternatives/day versus the recommended two ( StnTx ) and to preferentially engage in daily weight-bearing PA . Ctrl were provided the guidelines . RESULTS : Baseline anthropometry did not differ among groups . At 12 months ( n = 73 ) , all groups increased height ( p < 0.001 ) and lean mass ( p < 0.001 ) . ModTx decreased BAZ ( p < 0.001 ) ; % BF decreased in ModTx ( p = 0.018 ) , but not in StnTx ( p = 0.997 ) or Ctrl ( p = 0.998 ) . FM , WC and trunk fat mass all significantly increased in Ctrl ( p < 0.001 ) . At baseline and three months , fatty acids did not differ among groups , however they did decrease in ModTx at six months [ C14:0 ( −0.07 % , p = 0.053 ) , C15:0 ( −0.04 % , p = 0.049 ) , C17:0 ( −0.09 % , p = 0.036 ) ] . CONCLUSION : Participating in a family centered-lifestyle intervention that focused on Canadian dietary and PA Guidelines and emphasized increasing milk and alternatives and weight-bearing PA had positive effects on reducing adiposity in OW/OB children . Guidelines are appropriate for the obese pediatric population but need to be individualized to meet the needs of the family . Additional studies are warranted to test the use of biochemical indices to assess compliance to milk and alternative intakes in OW/OB children participating in lifestyle interventions .RésuméOBJECTIFS : Les interventions contre l’obésité juvénile devraient être centrées sur la famille et sur les habitudes de vie qui produisent des baisses durables de l’adiposité . L’objectif premier de notre essai comparatif r and omisé était de tester une intervention sur le mode de vie centrée sur la famille utilisant le Guide alimentaire canadien et les Directives canadiennes en matière d’activité physique ( AP ) pour réduire les écarts Z de l’indice de masse corporelle en fonction de l’âge ( ZIA ) chez les enfants en surpoids et obèses (SP/OB).MÉTHODE : Des enfants ( n = 78 ; 6–8,5 ans ) ont été affectés de façon aléatoire aux groupes d’intervention st and ard ( StnTx ) ou modifiée ( ModTx ) ou à un groupe témoin . Nous avons pris les mesures suivantes au départ et tous les trois mois pendant un an : anthropométrie , ZIA , périmètre ombilical ( PO ) , et des scanographies d’absorptiométrie biphotonique à rayons X pour obtenir le pourcentage de masse grasse ( % MG ) , la masse adipeuse ( MA ) et la masse adipeuse du tronc . Les acides gras , mesurés par chromatographie gazeuse , ont servi à évaluer la conformité aux interventions avec lait et substituts au cours des six premiers mois . Six séances d’intervention ont été fondées sur le Guide alimentaire canadien et les Directives canadiennes en matière d’AP et ont été individualisées pour répondre aux besoins de la famille . Les sujets de l’intervention modifiée ( ModTx ) ont reçu l’instruction de consommer quatre portions de lait et substituts par jour au lieu des deux portions recomm and ées ( StnTx ) et de pratiquer de préférence une AP de port de poids quotidiennement . Les témoins ont reçu le Guide et les Directives sans autre instruction . RÉSULTATS : L’anthropométrie de chaque groupe n’était pas différente au départ . Après 12 mois ( n = 73 ) , la taille ( p < 0,001 ) et la masse maigre ( p < 0,001 ) ont augmenté dans tous les groupes . Le ZIA a diminué dans le groupe ModTx ( p < 0,001 ) ; le % MG a diminué dans le groupe ModTx ( p = 0,018 ) , mais pas dans le groupe StnTx ( p = 0,997 ) ni dans le groupe témoin ( p = 0,998 ) . La MA , le PO et la masse adipeuse du tronc ont tous présenté une hausse significative dans le groupe témoin ( p < 0,001 ) . Au départ et après trois mois , les acides gras de chaque groupe n’étaient pas différents , mais ils ont diminué dans le groupe ModTx au bout de six mois [ C14:0 ( −0,07 % , p = 0,053 ) , C15:0 ( −0,04 % , p = 0,049 ) , C17:0 ( −0,09 % , p = 0,036 ) ] . CONCLUSION : La participation à une intervention sur le mode de vie centrée sur la famille , utilisant le Guide alimentaire et les Directives d’AP du Canada et insistant sur l’augmentation de la consommation de lait et de substituts et de l’AP de port de poids a eu des effets positifs sur la réduction de l’adiposité chez des enfants SP/OB . Les directives conviennent à la population pédiatrique obèse , mais elles doivent être individualisées pour répondre aux besoins de la famille . Il faudrait mener d’autres études pour tester l’utilisation d’indices biochimiques pour évaluer la conformité aux apports en lait et en substituts chez les enfants SP/OB qui participent à des interventions sur le mode de vie OBJECTIVE We conducted a study to determine if wearing a pedometer affects weight , body mass index ( BMI ) , or mediators of physical activity among families . METHODS Eighty-seven families were r and omized to 1 of 3 treatments : pedometer plus education ( PE ) , pedometer ( P ) , or control ( C ) . Participants in the PE and P groups wore pedometers and were encouraged to walk 10,000 steps daily for 12 weeks . PE group participants attended 6 sessions on healthy eating and exercise . Participants were surveyed about their knowledge and attitudes about healthy eating and physical activity prior to r and omization , at the end of the intervention , and 9 months later . Their heights and weights were measured and BMI calculated . RESULTS Children 's BMI percentile decreased from baseline to end of intervention ( -0.18 % ) and at 9-month follow-up ( -0.08 % ) but did not differ by treatment . Children 's BMI percentile varied by parental obesity status ( average BMI percentile was 88.7 % for children of obese parents and 78.5 % for children of non-obese parents ) . Parents ' weight decreased slightly by intervention 's end ( 0.6 pounds ) and at 9 months ( 1.2 pounds ) , but change was similar among groups . Attitudes about their physical activity level relative to their peers improved significantly among children and parents wearing the pedometer . Self-efficacy improved for parents wearing the pedometer . Both children and parents felt the pedometer increased their activity level , but most were unlikely to wear it beyond the intervention . CONCLUSIONS The pedometer had little impact on the activity level , weight , or BMI of participants OBJECTIVE To evaluate the efficacy of behavioral weight control intervention with a peer-enhanced activity intervention versus structured aerobic exercise in decreasing body mass index ( BMI ) and z- BMI in overweight adolescents . STUDY DESIGN Participants were r and omized to 1 of 2 group-based treatment conditions : ( 1 ) cognitive behavioral treatment with peer-enhanced adventure therapy or ( 2 ) cognitive behavioral weight control treatment with supervised aerobic exercise . Participants included 118 overweight adolescents , ages 13 to 16 years , and a primary caregiver . Changes in BMI , st and ardized BMI , percent over BMI , and waist circumference were examined . RESULTS Analysis of variance on the basis of intent-to-treat indicated significant decreases in all weight change outcomes at the end of treatment , with significant decreases maintained at the 12-month follow-up . No differences in treatment conditions were observed . Secondary analyses indicated that adherence with attendance and completion of weekly diet records contributed significantly to reductions in BMI . CONCLUSIONS A cognitive behavioral weight control intervention combined with supervised aerobic exercise or peer-enhanced adventure therapy is equally effective in short-term reduction of BMI and z- BMI in overweight adolescents . Adherence , as measured with session attendance and self-monitoring , is a key dimension of weight change Background : Obese adolescents are at risk for type 2 diabetes mellitus ( T2DM ) . Obesity interventions delivered through media , such as the web and text messages [ short message service ( SMS ) ] may be beneficial when targeting obese adolescents . Methods : A r and omized controlled trial , Pace-Internet for Diabetes Prevention Intervention ( PACEi-DP ) , compared three forms of an obesity intervention to usual care ( UC ) : ( a ) website only ( W ) ; ( b ) website , monthly group sessions , and follow-up calls ( WG ) ; and ( c ) website and SMS ( WSMS ) . Participants were overweight or obese adolescents at risk for T2DM ( n = 101 ; age 12–16 years ; mean body mass index ( BMI ) percentile = 97.6 ; 74.3 % Hispanic ) . In addition to the website , WSMS participants received SMS supporting intervention goals and behavioral strategies and communicated via SMS with a case manager . WG participants had additional group activities related to weight loss and received follow-up calls from a health coach . UC participants were given printed material s and encouraged to attend three initial group sessions . Repeated measures mixed model regression analyses tested treatment effects for anthropometric , behavioral , and behavioral change strategy outcomes . Results : There were no treatment effects for BMI , adiposity , physical activity , or diet at 12 months . Treatment effects were observed for sedentary behavior , with the W arm having a greater decrease in sedentary behavior ( 4.9 to 2.8 h/day ) than the UC arm ( p = .006 ) . Conclusion : Although not sufficient to produce weight loss , the combination of web intervention and group sessions with telephone follow-up yielded improvements in sedentary behavior and in the use of behavior change strategies expected to lead to behavior change BACKGROUND We evaluated the 12-month effects of the COPE ( Creating Opportunities for Personal Empowerment ) Healthy Lifestyles TEEN ( Thinking , Emotions , Exercise , Nutrition ) program versus an attention control program ( Healthy Teens ) on overweight/obesity and depressive symptoms in high school adolescents . METHODS A cluster r and omized controlled trial was conducted . Participants were 779 culturally diverse adolescents in the US Southwest . COPE is a cognitive-behavioral skills-building intervention with 20 min of physical activity integrated into a health course and taught by teachers once a week for 15 weeks . Outcome measures included body mass index ( BMI ) and depressive symptoms . RESULTS COPE teens had a significantly lower BMI at 12 months ( F(1,698 ) = 11.22 , p = .001 ) than Healthy Teens ( 24.95 versus 25.48 ) . There was a significant decrease in the proportion of overweight and obese COPE teens from baseline to 12 months ( χ(2 ) = 5.40 , p = .02 ) as compared with Healthy Teens . For youth who began the study with extremely elevated depressive symptoms , COPE teens had significantly lower depression at 12 months compared with Healthy Teens ( COPE M = 42.39 ; Healthy Teens M = 57.90 ) ; ( F(1 , 12 ) = 5.78 , p = .03 ) . CONCLUSIONS COPE can improve long-term physical and mental health outcomes in teens Objective To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children . Design R and omised controlled trial nested within a baseline cross sectional survey of body mass index ( BMI ) . R and omisation and outcomes measurement , but not participants , were blinded to group assignment . Setting 45 family practice s ( 66 general practitioners ) in Melbourne , Australia . Participants 3958 children visiting their general practitioner in May 2005-July 2006 were surveyed for BMI . Of these , 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were r and omised to intervention ( n=139 ) or control ( n=119 ) groups . Children who were very obese ( UK BMI z score ≥3.0 ) were excluded . Intervention Four st and ard consultations over 12 weeks targeting change in nutrition , physical activity , and sedentary behaviour , supported by purpose design ed family material s. Main outcomes measures Primary measure was BMI at 6 and 12 months after r and omisation . Secondary measures were mean activity count/min by 7-day accelerometry , nutrition score from 4-day abbreviated food frequency diary , and child health related quality of life . Differences were adjusted for socioeconomic status , age , sex , and baseline BMI . Results Of 781 eligible children , 258 ( 33 % ) entered the trial ; attrition was 3.1 % at 6 months and 6.2 % at 12 months . Adjusted mean differences ( intervention − control ) at 6 and 12 months were , for BMI , −0.12 ( 95 % CI −0.40 to 0.15 , P=0.4 ) and −0.11 ( −0.45 to 0.22 , P=0.5 ) ; for physical activity in counts/min , 24 ( −4 to 52 , P=0.09 ) and 11 ( −26 to 49 , P=0.6 ) ; and , for nutrition score , 0.2 ( −0.03 to 0.4 , P=0.1 ) and 0.1 ( −0.1 to 0.4 , P=0.2 ) . There was no evidence of harm to the child . Costs to the healthcare system were significantly higher in the intervention arm . Conclusions Primary care screening followed by brief counselling did not improve BMI , physical activity , or nutrition in overweight or mildly obese 5 - 10 year olds , and it would be very costly if universally implemented . These findings are at odds with national policies in countries including the US , UK , and Australia . Trial registration IS RCT N 52511065 ( www.is rct n.org Prevalence of obesity among American Indian children is higher than the general US population . The school environment and teachers play important roles in helping students develop healthy eating habits . The aim of this prospect i ve study was to examine teachers ' classroom and school food practice s and beliefs and the effect of teacher training on these practice s and beliefs . Data were used from the Bright Start study , a group-r and omized , school-based trial that took place on the Pine Ridge American Indian reservation ( fall 2005 to spring 2008 ) . Kindergarten and first- grade teachers ( n=75 ) from 14 schools completed a survey at the beginning and end of the school year . Thirty-seven survey items were evaluated using mixed-model analysis of variance to examine the intervention effect for each teacher- practice and belief item ( adjusting for teacher type and school as r and om effect ) . At baseline , some teachers reported classroom and school food practice s and beliefs that supported health and some that did not . The intervention was significantly associated with lower classroom use of c and y as a treat ( P=0.0005 ) and fast-food rewards ( P=0.008 ) ; more intervention teachers disagreed that fast food should be offered as school lunch alternatives ( P=0.019 ) , that it would be acceptable to sell unhealthy foods as part of school fundraising ( P=0.006 ) , and that it would not make sense to limit students ' food choices in school ( P=0.035 ) . School-based interventions involving teacher training can result in positive changes in teachers ' classroom food practice s and beliefs about the influence of the school food environment in schools serving American Indian children on reservations OBJECTIVE Many adolescents do not meet national guidelines for participation in regular moderate or vigorous physical activity ( PA ) ; limitations on sedentary behaviors ; or dietary intake of fruits and vegetables , fiber , or total dietary fat . This study evaluated a health care-based intervention to improve these behaviors . DESIGN R and omized controlled trial . SETTING Primary care with follow-up at home . PARTICIPANTS Eight hundred seventy-eight adolescent girls and boys aged 11 to 15 years . INTERVENTIONS Two experimental conditions : ( 1 ) Primary care , office-based , computer-assisted diet and PA assessment and stage-based goal setting followed by brief health care provider counseling and 12 months of monthly mail and telephone counseling and ( 2 ) a comparison condition addressing sun exposure protection . MAIN OUTCOME MEASURES Minutes per week of moderate plus vigorous PA measured by self-report and accelerometer ; self-report of days per week of PA and sedentary behaviors ; and percentage of energy from fat and servings per day of fruits and vegetables measured by three 24-hour diet recalls . Body mass index ( calculated as weight in kilograms divided by the square of height in meters ) was a secondary outcome . RESULTS Compared with adolescents in the sun protection condition , girls and boys in the diet and PA intervention significantly reduced sedentary behaviors ( intervention vs control change , 4.3 to 3.4 h/d vs 4.2 to 4.4 h/d for girls , respectively [ P = .001 ] ; 4.2 to 3.2 h/d vs 4.2 to 4.3 h/d for boys , respectively [ P = .001 ] ) . Boys reported more active days per week ( intervention vs control change : 4.1 to 4.4 d/wk vs 3.8 to 3.8 d/w , respectively [ P = .01 ] ) , and the number of servings of fruits and vegetables for girls approached significance ( intervention vs control change , 3.5 to 4.2 servings/d vs 3.5 to 3.9 servings/d , respectively [ P = .07 ] ) . No intervention effects were seen with percentage of calories from fat or minutes of PA per week . Percentage of adolescents meeting recommended health guidelines was significantly improved for girls for consumption of saturated fat ( intervention vs control change , 23.4 % to 41.0 % vs 18.5 % to 31 % , respectively [ relative risk , 1.33 ; 95 % confidence interval , 1.01 - 1.68 ] ) and for boys ' participation in d/wk of PA ( intervention vs control change , 45.3 % to 55.4 % vs 41.9 % to 38.0 % , respectively [ relative risk , 1.47 ; 95 % confidence interval , 1.19 - 1.75 ] ) . No between-group differences were seen in body mass index . CONCLUSIONS Improvements in some diet , PA , and sedentary behaviors in adolescents can be enabled through the use of a 1-year , integrated intervention using the computer , health provider counseling , mail , and telephone . The amount of intervention received may contribute to its efficacy BACKGROUND Prevention of childhood obesity is a public health priority . Parents influence a child 's weight by modeling healthy behaviors , controlling food availability and activity opportunities , and appropriate feeding practice s. Thus interventions should target education and behavioral change in the parent , and positive , mutually reinforcing behaviors within the family . METHODS This paper presents the design , rationale and baseline characteristics of Kids and Adults Now ! - Defeat Obesity ( KAN-DO ) , a r and omized controlled behavioral intervention trial targeting weight maintenance in children of healthy weight , and weight reduction in overweight children . 400 children aged 2 - 5 and their overweight or obese mothers in the Triangle and Triad regions of North Carolina are r and omized equally to control or the KAN-DO intervention , consisting of mailed family kits encouraging healthy lifestyle change . Eight ( monthly ) kits are supported by motivational counseling calls and a single group session . Mothers are targeted during a hypothesized " teachable moment " for health behavior change ( the birth of a new baby ) , and intervention content addresses : parenting skills ( ( e.g. , emotional regulation , authoritative parenting ) , healthy eating , and physical activity . RESULTS The 400 mother-child dyads r and omized to trial are 75 % white and 22 % black ; 19 % have a household income of $ 30,000 or below . At baseline , 15 % of children are overweight ( 85th-95th percentile for body mass index ) and 9 % are obese ( ≥ 95th percentile ) . CONCLUSION This intervention addresses childhood obesity prevention by using a family-based , synergistic approach , targeting at-risk children and their mothers during key transitional periods , and enhancing maternal self-regulation and responsive parenting as a foundation for health behavior change Many underserved school-age children do not meet the recommended guidelines for physical activity . While children ultimately depend on parents , they also look to schools for their access to developmentally appropriate physical activity . The present r and omized controlled trial study utilized a community – academic partnered participatory research approach to evaluate the impact of a culturally sensitive , comprehensive , school-based , program , Kids N Fitness © , on body mass index ( BMI ) , and child physical activity behavior , including : daily physical activity , team sports participation , attending PE class , and TV viewing/computer game playing , among underserved children ages 8–12 ( N = 251 ) in Los Angeles County . All measures were collected at baseline , 4 and 12 months post-intervention . Students who participated in the KNF program had significant decreases in BMI Z-score , TV viewing , and an increase in PE class attendance from baseline to the 12 month follow-up . Our study shows the value of utilizing community – academic partnerships and a culturally sensitive , multi-component , collaborative intervention Objectives : Obesity is a rising problem in adolescents related to unhealthy behaviours . Commitment devises are one type of behavioural intervention that may help people change their behaviours . The current pilot trial tests whether commitment devices delivered via text message help adolescents maintain their recent weight loss . Methods : During a 12-week pilot trial , adolescents who attended a weight loss camp were r and omly assigned to either received text messages that contained only information , i.e. advice , about weight loss management ( n = 13 ) or asked for them to commit to following the same advise ( n = 14 ) . Results : The BMI of the adolescents in the commitment group did not change . In contrast , the BMI of adolescents in the information group increased . A linear regression revealed that group was a significant predictor of BMI change . A logistic regression revealed that adolescents in the information group were nearly eight times more likely to regain weight than those in the commitment group . Conclusions : This is the first study with adolescents to show weight maintenance using a commitment device . The results suggest that commitment devices can help adolescents maintain their recent weight loss IMPORTANCE Evidence of effective treatment of childhood obesity in primary care setting s is limited . OBJECTIVE To examine the extent to which computerized clinical decision support ( CDS ) delivered to pediatric clinicians at the point of care of obese children , with or without individualized family coaching , improved body mass index ( BMI ; calculated as weight in kilograms divided by height in meters squared ) and quality of care . DESIGN , SETTING , AND PARTICIPANTS We conducted a cluster-r and omized , 3-arm clinical trial . We enrolled 549 children aged 6 to 12 years with a BMI at the 95 % percentile or higher from 14 primary care practice s in Massachusetts from October 1 , 2011 , through June 30 , 2012 . Patients were followed up for 1 year ( last follow-up , August 30 , 2013 ) . In intent-to-treat analyses , we used linear mixed-effects models to account for clustering by practice and within each person . INTERVENTIONS In 5 practice s r and omized to CDS , pediatric clinicians received decision support on obesity management , and patients and their families received an intervention for self-guided behavior change . In 5 practice s r and omized to CDS + coaching , decision support was augmented by individualized family coaching . The remaining 4 practice s were r and omized to usual care . MAIN OUTCOMES AND MEASURES Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set ( HEDIS ) performance measures for obesity during the 1-year follow-up . RESULTS At baseline , mean ( SD ) patient age and BMI were 9.8 ( 1.9 ) years and 25.8 ( 4.3 ) , respectively . At 1 year , we obtained BMI from 518 children ( 94.4 % ) and HEDIS measures from 491 visits ( 89.4 % ) . The 3 r and omization arms had different effects on BMI over time ( P = .04 ) . Compared with the usual care arm , BMI increased less in children in the CDS arm during 1 year ( -0.51 [ 95 % CI , -0.91 to -0.11 ] ) . The CDS + coaching arm had a smaller magnitude of effect ( -0.34 [ 95 % CI , -0.75 to 0.07 ] ) . We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm ( adjusted odds ratio , 2.28 [ 95 % CI , 1.15 - 4.53 ] ) and CDS + coaching arm ( adjusted odds ratio , 2.60 [ 95 % CI , 1.25 - 5.41 ] ) and higher use of HEDIS codes for nutrition or physical activity counseling ( CDS arm , 45 % ; CDS + coaching arm , 25 % ; P < .001 compared with usual care arm ) . CONCLUSIONS AND RELEVANCE An intervention that included computerized CDS for pediatric clinicians and support for self-guided behavior change for families result ed in improved childhood BMI . Both interventions improved the quality of care for childhood obesity . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01537510 AIM Childhood overweight and obesity is a significant community health problem with severe long-term complications . This paper aims to evaluate a four-by-two-hour weekly group parent education programme targeting children who are overweight . METHODS A r and omised time series design with wait-list controls was conducted for overweight and obese children aged 3 - 10 years . RESULTS A statistically significant reduction in child body mass index and energy intake was found post treatment ; no differences were reported for child sedentary electronic media time , physical activity and waist circumference . Children 's baseline activity levels were found to be at or slightly above national recommended st and ards . No change occurred in primary parent body mass index or waist circumference after treatment . CONCLUSIONS A brief group education programme for parents was effective in reducing childhood overweight at 3 months follow-up OBJECTIVE Although there is general agreement that parents should be involved in pediatric obesity treatment , few studies have investigated the effectiveness of interventions that target parents exclusively . Moreover , the effectiveness of this approach has not been adequately assessed with racially diverse families , particularly African Americans(AA ) , a group at high risk for elevated Body Mass Index ( BMI ) . METHODS NOURISH ( Nourishing Our Underst and ing of Role modeling to Improve Support and Health ) is a culturally-sensitive parenting intervention targeting overweight ( AA ) children ( ages 6 - 11 ; M BMI = 98.0%ile ) . Families ( N = 84 ; 61 % AA , 37 % White ) were r and omly assigned to NOURISH or a control group . RESULTS NOURISH families significantly improved on child BMI from pre- to post-testing after adjustment for r and om effects , baseline BMI , and child race . NOURISH parents were very satisfied with the intervention and would recommend it to other parents ; 91 % strongly or moderately agreed that NOURISH helped them eat in a healthier manner . CONCLUSIONS These pilot data suggest that NOURISH is acceptable and , with refinement , offers promise for reducing pediatric BMI . Outcomes , lessons learned , and parent feedback will inform a larger r and omized controlled trial Background : Latino children are disproportionately burdened by obesity . Objective : To assess whether body mass index ( BMI ) change in preadolescents reflected that of their participating parent . Methods : A total of 72 Latino overweight/obese preadolescents ( BMI ≥ 85 % ) and a parent participated in a r and omized controlled trial . The intervention group received 5 monthly 60-minute sessions at a recreation center ( group physical activity , goal setting ) . The control group received 2 st and ard-of-care clinic visits plus a group discussion . Results : Between baseline and 6-month follow-up , 47 % of children ( mean change = -0.37 , SD = 2.48 ) and 63 % of parents ( mean change = -0.88 , SD = 3.53 ) decreased their BMI . Parent — child dyad BMI change was significantly correlated ( r = .53 , P = .001 ) . In linear modeling , those preadolescents in the control group were more likely to lose absolute BMI units ( -0.96 , P = .03 ) ; whereas those who had parents who gained BMI over the time interval were more likely to increase their BMI ( 0.17 , P = .008 ) . Conclusions : Obesity interventions should focus on the parent — child dyad Background : Parent-child treatments have been shown to be superior to child-focused treatments of childhood obesity . Yet until now , the comparative effectiveness of parent-only and parent-child approaches has been little studied . Method : Fifty-six obese children and their families were r and omly assigned to a 16-session cognitive behavioral therapy ( CBT ) for the parents only or for a combined treatment of parents and children . Children ’s percent overweight , the body mass index of their mothers , and behavioral and psychological problems of children and mothers were assessed . Results : Both treatments reduced children ’s percent overweight significantly and equally by 6-month follow-up . Also both treatments provided similar results in reducing general behavior problems ( externalizing and internalizing behavior problems ) , global and social anxiety , and depression . Conclusions : Our results point to a comparable efficacy of the two treatments . Further , psychological well-being of both mothers and children can be improved in a CBT for obese children and their parents . Future studies should focus on finding ways to improve the adherence of families to long-term treatment of obesity in childhood OBJECTIVE To examine the effectiveness of a primary care-based obesity intervention over the first year ( 6 intervention contacts ) of a planned 2-year study . DESIGN Cluster r and omized controlled trial . SETTING Ten pediatric practice s , 5 intervention and 5 usual care . PARTICIPANTS Four hundred seventy-five children aged 2 to 6 years with body mass index ( BMI ) in the 95th percentile or higher or 85th to less than 95th percentile if at least 1 parent was overweight ; 445 ( 93 % ) had 1-year outcomes . INTERVENTION Intervention practice s received primary care restructuring , and families received motivational interviewing by clinicians and educational modules targeting television viewing and fast food and sugar-sweetened beverage intake . OUTCOME MEASURES Change in BMI and obesity-related behaviors from baseline to 1 year . RESULTS Compared with usual care , intervention participants had a smaller , nonsignificant change in BMI ( -0.21 ; 95 % confidence interval [ CI ] , -0.50 to 0.07 ; P = .15 ) , greater decreases in television viewing ( -0.36 h/d ; 95 % CI , -0.64 to -0.09 ; P = .01 ) , and slightly greater decreases in fast food ( -0.16 serving/wk ; 95 % CI , -0.33 to 0.01 ; P = .07 ) and sugar-sweetened beverage ( -0.22 serving/d ; 95 % CI , -0.52 to 0.08 ; P = .15 ) intake . In post hoc analyses , we observed significant effects on BMI among girls ( -0.38 ; 95 % CI , -0.73 to -0.03 ; P = .03 ) but not boys ( 0.04 ; 95 % CI , -0.55 to 0.63 ; P = .89 ) and among participants in households with annual incomes of $ 50 000 or less ( -0.93 ; 95 % CI , -1.60 to -0.25 ; P = .01 ) but not in higher-income households ( 0.02 ; 95 % CI , -0.30 to 0.33 ; P = .92 ) . CONCLUSION After 1 year , the High Five for Kids intervention was effective in reducing television viewing but did not significantly reduce BMI OBJECTIVE The primary goal was to evaluate sex differences in child weight control programs that targeted increasing physical activity ( increase ) or the combination of reducing sedentary behavior and increasing physical activity ( combined ) . A second goal was to evaluate the benefits of family-based interventions on nontargeted siblings . RESEARCH METHODS AND PROCEDURES Sixty-seven families with obese children and 89 siblings were r and omized to interventions that targeted increasing physical activity ( increase ) or the combination of reducing sedentary behavior and increasing physical activity ( combined ) . Targeted participants and nontargeted siblings were followed for 1 year . RESULTS At 12 months , boys showed significantly better percentages of overweight changes ( -15.8 % ) for the combined treatment than girls ( -1.0 % ) , with no significant differences for the increase intervention for boys ( -9.3 % ) or girls ( -7.6 % ) . Boys adhered to treatment better than girls ( p < 0.01 ) . Adherence and predilection for physical activity were significant predictors of targeted child weight loss at 1 year in multiple regression analysis . Predictors of sibling weight loss included age , number of siblings , targeted child percentage of overweight change , and the interaction of group assignment by same sex of treated sibling . DISCUSSION Gender may influence response to programs that attempt to decrease sedentary behavior , and generalization of treatment effects to siblings may depend on the intervention and characteristics of the siblings BACKGROUND General practitioners ( GPs ) could make an important contribution to management of childhood overweight . However , there are no efficacy data to support this , and the feasibility of this approach is unknown . OBJECTIVES To determine if GPs and families can be recruited to a r and omized controlled trial ( RCT ) , and if GPs can successfully deliver an intervention to families with overweight/obese 5- to 9-year-old children . METHODS A convenience sample of 34 GPs from 29 family medical practice s attended training sessions on management of childhood overweight . Practice staff trained in child anthropometry conducted a cross-sectional body mass index ( BMI ) survey of 5- to 9-year-old children attending these practice s. The intervention focused on achievable goals in nutrition , physical activity and sedentary behaviour , and was delivered in four solution-focused behaviour change consultations over 12 weeks . RESULTS General practitioners were recruited from across the sociodemographic spectrum . All attended at least two of the three education sessions and were retained throughout the trial . Practice staff weighed and measured 2112 children in the BMI survey , of whom 28 % were overweight/obese ( 17.5 % overweight , 10.5 % obese ) , with children drawn from all sociodemographic quintiles . Of the eligible overweight/obese children , 163 ( 40 % ) were recruited and retained in the LEAP RCT ; 96 % of intervention families attended at least their first consultation . CONCLUSIONS Many families are willing to tackle childhood overweight with their GP . In addition , GPs and families can participate successfully in the careful trials that are needed to determine whether an individualized , family-based primary care approach is beneficial , harmful or ineffective PURPOSE . : The purpose of the study was to examine the feasibility and initial efficacies of parent- and /or child-focused online interventions and variables correlated with child body mass index percentile change . DESIGN AND METHODS . : A feasibility and cluster r and omized controlled pilot study was used . RESULTS . : Recruitment was more effective at parent-teacher conferences compared with when material s were sent home with fifth- to eighth- grade culturally diverse students . Retention was 90 % for students and 62 - 74 % for parents . Authoritative parent feeding behaviors were associated with lower child body mass index . A larger study is warranted . PRACTICE IMPLICATION S. : Online approaches may provide a feasible option for childhood obesity prevention and amelioration BACKGROUND School-based health centers ( SBHCs ) may be an ideal setting to address obesity in adolescents because they provide increased access to a traditionally difficult-to-reach population . The study evaluated the feasibility of adding a health educator ( HE ) to SBHC teams to provide support and increase the delivery of preventive services for overweight or obese adolescents . METHODS Adolescents with BMI ≥85 % recruited from two SBHCs were r and omized to a control group ( CG ) or an intervention group ( IG ) . Both groups received preventive services , including physical examinations and laboratory screening in the SBHC . The educator met with the IG during the academic year , utilizing motivational interviewing techniques to set lifestyle goals . Text messaging was used to reinforce goals between visits . RESULTS Eighty-two students ( 15.7±1.5 years of age ; BMI , 31.9±6.2 kg/m(2 ) ) were enrolled in the IG and 83 in the control group ( 16.0±1.5 years of age ; BMI , 31.6±6.5 kg/m(2 ) ) . Retention was 94 % in the IG and 87 % in the CG . A total of 54.5 % of the IG and 72.2 % of the CG decreased or maintained BMI z-score ( less than 0.05 increase ; p=0.025 ) . Sports participation was higher in the CG ( 47 % vs. 28 % in the IG ; p=0.02 ) . Mean BMI z-score change was -0.05±0.2 for students participating in sports vs. 0.01±0.2 for those not ( p=0.09 ) . CONCLUSIONS This SBHC intervention showed successful recruitment and retention of participants and delivery of preventive services in both groups . Meeting with an HE did not improve BMI outcomes in the IG . Confounding factors , including sports participation and SBHC utilization , likely contributed to BMI outcomes IMPORTANCE Racial/ethnic and socioeconomic disparities exist across risk factors for childhood obesity . OBJECTIVE To examine the effectiveness of a home-based intervention to improve household routines known to be associated with childhood obesity among a sample of low-income , racial/ethnic minority families with young children . DESIGN R and omized trial . SETTING The intervention was delivered in the families ' homes . PARTICIPANTS The study involved 121 families with children aged 2 to 5 years who had a television ( TV ) in the room where he or she slept ; 111 ( 92 % ) had 6-month outcome data ( 55 intervention and 56 control ) . The mean ( SD ) age of the children was 4.0 ( 1.1 ) years ; 45 % were overweight/obese . Fifty-two percent of the children were Hispanic , 34 % were black , and 14 % were white/other . Nearly 60 % of the families had household incomes of $ 20,000 or less . INTERVENTIONS The 6-month intervention promoted 4 household routines , family meals , adequate sleep , limiting TV time , and removing the TV from the child 's bedroom , using ( 1 ) motivational coaching at home and by phone , ( 2 ) mailed educational material s , and ( 3 ) text messages . Control subjects were mailed material s focused on child development . MAIN OUTCOMES AND MEASURES Change in parent report of frequency of family meals ( times/wk ) , child sleep duration ( hours/d ) , child weekday and weekend day TV viewing ( hours/d ) , and the presence of a TV in the room where the child slept from baseline to 6 months . A secondary outcome was change in age- and sex-adjusted body mass index ( calculated as weight in kilograms divided by height in meters squared ) . RESULTS Compared with control subjects , intervention participants had increased sleep duration ( 0.75 hours/d ; 95 % CI , 0.06 to 1.44 ; P = .03 ) , greater decreases in TV viewing on weekend days ( -1.06 hours/d ; 95 % CI , -1.97 to -0.15 ; P = .02 ) , and decreased body mass index ( -0.40 ; 95 % CI , -0.79 to 0.00 ; P = .05 ) . No significant intervention effect was found for the presence of a TV in the room where the child slept or family meal frequency . CONCLUSIONS AND RELEVANCE Our results suggest that promoting household routines , particularly increasing sleep duration and reducing TV viewing , may be an effective approach to reduce body mass index among low-income , racial/ethnic minority children . Longer-term studies are needed to determine maintenance of behavior change . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01565161 BACKGROUND Effective treatment of childhood obesity requires a multi-factorial approach and should target factors impacting on a child 's environment . OBJECTIVE To explore the impact of three treatment programs on parental child-feeding practice s at 6 , 12 and 24 months post-program . SUBJECTS/INTERVENTION : Overweight children ( n=159 ) aged 5 - 7 years , recruited to the Hunter Illawarra Kids Challenge Using Parent Support ( HIKCUPS ) r and omized controlled trial with three treatment arms ; a dietary modification program , a physical activity skill development program or a combination of both programs . Main outcome measures . The Child Feeding Question naire ( CFQ ) , a vali date d 31-item question naire measuring child-feeding practice s , completed by parents . Statistical analysis . Linear mixed models were used to assess change over time and to determine differences by intervention group . RESULTS A significant decrease ( p<0.01 ) in CFQ domain scores were reported and sustained at 24 months for all groups , in the domain of pressure to eat ( mean+/-SEM , 1.8+/-0.06 , 1.6+/-0.06 ) with increases in degree of monitoring ( 4.0+/-0.07 , 4.2+/-0.06 ) . The domain of restriction showed significant decreases in dietary intervention groups only ( baseline 3.9+/-0.05 , 24 months 3.7+/-0.06 ) , the domain scores for concern were found to be strongly associated with child BMI z-score ( r=0.73 , p < 0.001 ) at baseline only . CONCLUSIONS This study provides evidence that specific child-feeding domains are modifiable in the context of a targeted obesity intervention and further that changes can be sustained over time . HIKCUPS study : National Centre for Clinical Trials ( NCT ) : 00107692 clinical trials.gov Identifier : NCT00107692 http:// clinical trials.gov/ct2/home OBJECTIVE NOURISH is a community-based treatment program for parents of overweight and obese children ( ages 6 - 11 , BMI ≥ 85 th percentile ) . This study examined the impact of Nourishing Our Underst and ing of Role modeling to Improve Support and Health on child and parent dietary intake , secondary trial outcomes . METHODS In Virginia from 2008 to 2009 , this r and omized controlled pilot was implemented and dietary assessment of parents and children conducted at baseline , post-test , and 6-month follow-up . Parents ( 85 % female , 62 % African American , mean BMI = 34.1 ± 9.1 ) were r and omized into intervention ( n=46 ) or control ( n=50 ) groups . Children 's ( mean age=8.6 ± 1.5 ) mean Body Mass Index percentile was 98.1 ± 2.6 . Parents completed 24-hour dietary records for themselves and their child(ren ) . Repeated measures analyses assessed treatment effects over time . T-tests evaluated within-group changes from baseline to post-test and to follow-up , using a modified intent-to-treat approach . RESULTS Both groups reported significant dietary changes , with few treatment effects found . For parents in NOURISH , significant improvements were found in intakes of total kilocalories/day , grams/day of carbohydrates and sugar , and percent calories from protein ( p<0.05 ) . Among control group children , significant improvements in total kilocalories/day and grams/day of carbohydrates and sugar were found ( p<0.05 ) . CONCLUSIONS Among parents who self-select into a childhood obesity program , minimal intervention can elicit short-term dietary changes comparable to those of a structured intervention Objective : The percentage of obese children in the United States has increased dramatically over the past three decades , particularly among ethnic/ racial minorities . This study sought to examine the impact of a clinical case-management intervention based upon the Transtheoretical Model ( TTM ) to reduce obesity and increase physical activity in children . Methods : Nineteen obese African-American children ages 8 - 12 were recruited from two pediatric clinics and were r and omized to either a 12-week intervention group or a control group . Dependent variables included body mass index ( BMI ) percentile , physical activity , and stage of change for the child and parent . Results : In comparison to the control group , the intervention group demonstrated significant decreases in BMI and improvements in daily vigorous physical activity . The children in the intervention group demonstrated movement toward action/maintenance stages of change . Conclusions : A 12-week TTM-based case management intervention can have a favorable impact on obesity and physical activity in African-American child AIM To report our experiences with recruiting overweight and obese 13- to 16-year-olds for the Loozit ® weight management r and omised control trial ( RCT ) and to identify effective strategies for recruiting adolescents from the community to a treatment trial . METHODS The Loozit RCT is a two-arm , community-based , lifestyle intervention that aims to evaluate the effect of additional therapeutic contact provided via telephone coaching and electronic communications as an adjunct to the Loozit group programme . Strategic areas that were targeted to recruit adolescents included media , schools , health professionals and community organisations . The programme aim ed to recruit a cohort of 12 - 16 adolescents ( body mass index z-score range 1.0 - 2.5 ) aged 13 - 16 years every 3 months over 3 years . Information regarding recruitment and eligibility to participate was initially assessed during a telephone screen . The relative cost effectiveness of recruitment strategies was determined based on recruitment rates and costs including administrative costs and research assistant time . RESULTS Out of 474 enquiries , 32 % result ed in an enrollment to the RCT . Newspaper articles and school newsletters accounted for nearly 60 % of enquiries and enrollments and were the most cost-effective recruitment strategies . Common reasons for in eligibility for inclusion in the RCT were adolescents being too young ( 21 % ) and parents consenting but adolescents refusing to participate ( 17 % ) . CONCLUSIONS The most successful recruitment strategies for the Loozit RCT were local newspapers and school newsletters . Future studies should consider involving a Public Relations department and other potentially cost-effective strategies such as peer recruitment BACKGROUND & AIMS R and omized controlled trials ( RCT ) have demonstrated the effectiveness of lifestyle interventions in obese children . However , the effectiveness of interventions for overweight , but no obese children has not been demonstrated yet by RCTs . METHODS A total of 66 overweight ( BMI > 90th < or = 97th percentile ) children ( mean age 11.5+/-1.6 years , 58 % females , mean BMI 23.4+/-1.5kg/m(2 ) ) were r and omized into a control group ( CG ) ( n=32 ; no intervention for a duration of 6 months ) or intervention group ( IG ) ( n=34 ; 6 months intervention " Obeldicks light " based on physical activity , nutrition education , and behaviour counselling ) . BMI , waist circumference , skinfold thickness , bioimpedance analyses , blood pressure , physical activity based on question naires , and three-day-weighed dietary records were determined at baseline ( T0 ) and 6 months ( T1 ) later . Degree of overweight was calculated as BMI -SDS . Comparisons were performed on an intention-to-treat approach . RESULTS The drop-out rate was 3 % in IG and 16 % in CG . At T1 , 94 % of the children in IG decreased their BMI -SDS and 24 % of them were normal weight . The changes between T0 and T1 in BMI -SDS differed significantly ( p<0.001 ) between IG and CG ( CG : + 0.05+/-0.19 BMI -SDS ; IG : -0.26+/-0.22 BMI -SDS ) . Similar findings were observed for blood pressure , waist circumference , skinfold thickness , and fat mass based on bioimpedance analyses . In the IG , energy , fat and sugar intake decreased significantly between T0 and T1 , while no significant changes were observed in the CG . CONCLUSIONS The lifestyle intervention was associated with an improvement of dietary patterns and was effective in reducing degree of overweight , fat mass , waist circumference , and blood pressure BACKGROUND Underserved children , particularly girls and those in urban communities , do not meet the recommended physical activity guidelines ( > 60min of daily physical activity ) , and this behavior can lead to obesity . The school years are known to be a critical period in the life course for shaping attitudes and behaviors . Children look to schools for much of their access to physical activity . Thus , through the provision of appropriate physical activity programs , schools have the power to influence apt physical activity choices , especially for underserved children where disparities in obesity-related outcomes exist . OBJECTIVES To evaluate the impact of a nurse directed , coordinated , culturally sensitive , school-based , family-centered lifestyle program on activity behaviors and body mass index . DESIGN , SETTING S AND PARTICIPANTS This was a parallel group , r and omized controlled trial utilizing a community-based participatory research approach , through a partnership with a University and 5 community schools . Participants included 251 children ages 8 - 12 from elementary schools in urban , low-income neighborhoods in Los Angeles , USA . METHODS The intervention included Kids N Fitness ( © ) , a 6-week program which met weekly to provide 45min of structured physical activity and a 45min nutrition education class for parents and children . Intervention sites also participated in school-wide wellness activities , including health and counseling services , staff professional development in health promotion , parental education newsletters , and wellness policies for the provision of healthy foods at the school . The Child and Adolescent Trial for Cardiovascular Health School Physical Activity and Nutrition Student Question naire measured physical activity behavior , including : daily physical activity , participation in team sports , attending physical education class , and TV viewing/computer game playing . Anthropometric measures included height , weight , body mass index , resting blood pressure , and waist circumference . Measures were collected at baseline , completion of the intervention phase ( 4 months ) , and 12 months post-intervention . RESULTS Significant results for students in the intervention , included for boys decreases in TV viewing ; and girls increases in daily physical activity , physical education class attendance , and decreases in body mass index z-scores from baseline to the 12 month follow-up . CONCLUSIONS Our study shows the value of utilizing nurses to implement a culturally sensitive , coordinated , intervention to decrease disparities in activity and TV viewing among underserved girls and boys OBJECTIVE Preventing weight gain in adults and excessive weight gain in children is a high priority . We evaluated the ability of a family-based program aim ed at increasing steps and cereal consumption ( for breakfast and snacks ) to reduce weight gain in children and adults . RESEARCH METHODS AND PROCEDURES Families ( n = 105 ) with at least one 8- to 12-year-old child who was at-risk-for-overweight or overweight ( design ated as the target child ) were recruited for the study . Eighty-two families were r and omly assigned to receive the family-based intervention and 23 families to the control condition . The 13-week intervention consisted of specific increases in daily steps ( an additional 2000 steps/d ) and consumption of 2 servings/d of ready-to-eat cereal . RESULTS The intervention was successful in increasing walking ( steps ) and cereal consumption . The intervention had positive , significant effects on percentage BMI -for-age and percentage body fat for target children and weight , BMI , and percentage body fat for parents . On further analysis , the positive effects of the intervention were seen largely in target girls and moms , rather than in target boys and dads . DISCUSSION This family-based weight gain prevention program based on small changes holds promise for reducing excessive weight gain in families and especially in growing overweight children OBJECTIVES To assess the impact of a culturally proficient dietary/physical activity intervention on changes in body mass index ( BMI ) ( kg/m 2 ) . STUDY DESIGN R and omized controlled trial ( Hip-Hop to Health Jr. ) conducted between September 1999 and June 2002 in 12 Head Start preschool programs in Chicago , Illinois . RESULTS Intervention children had significantly smaller increases in BMI compared with control children at 1-year follow-up , 0.06 vs 0.59 kg/m 2 ; difference -0.53 kg/m 2 ( 95 % CI -0.91 to -0.14 ) , P = .01 ; and at 2-year follow-up , 0.54 vs 1.08 kg/m 2 ; difference -0.54 kg/m 2 ( 95 % CI -0.98 to -0.10 ) , P = .02 , with adjustment for baseline age and BMI . The only significant difference between intervention and control children in food intake/physical activity was the Year 1 difference in percent of calories from saturated fat , 11.6 % vs 12.8 % ( P = .002 ) . CONCLUSIONS Hip-Hop to Health Jr. was effective in reducing subsequent increases in BMI in preschool children . This represents a promising approach to prevention of overweight among minority children in the preschool years BACKGROUND Insufficient evidence exists to support obesity prevention in paediatric primary care . OBJECTIVES To test a theory-based behaviour modification intervention delivered by trained paediatric primary care providers for obesity prevention . METHODS Efficacy trial with cluster r and omization ( practice level ) and a 12-session 12-month sweetened beverages decrease intervention or a comprehensive dietary and physical activity intervention , compared with a control intervention among children ages 8 - 12 years . RESULTS A low recruitment rate was observed . The increase in body mass index z-score ( BMI z ) for the 139 subjects ( 11 practice s ) r and omized to any of the two obesity interventions ( combined group ) was less than that of the 33 subjects ( five practice s ) r and omized to the control intervention ( -0.089 , 95 % confidence interval [ CI ] : -0.170 to -0.008 , P = 0.03 ) with a -1.44 kg weight difference ( 95 % CI : -2.98 to + 0.10 kg , P = 0.095 ) . The incidences of obesity and excess weight gain were lower in the obesity interventions , but the number of subjects was small . Post hoc analyses comparing the beverage only to the control intervention also showed an intervention benefit on BMI z ( -0.083 , 95 % CI : -0.165 to -0.001 , P = 0.048 ) . CONCLUSIONS For participating families , an obesity prevention intervention delivered by paediatric primary care clinicians , who are compensated , trained and continuously supported by behavioural specialists , can impact children 's BMI This study tested the effects of mastery criteria and contingent reinforcement in a family-based behavioral weight control program for obese children and their parents over two years . Families with obese children were r and omized to one of two groups . The experimental group was targeted and reinforced for mastery of diet , exercise , weight loss , and parenting skills . The control group was taught behavior-change strategies and provided noncontingent reinforcement at a pace yoked to the experimental group . Both groups received the same behavioral family-based educational components over 6 months of weekly meetings and six monthly follow-up meetings . Results showed significantly better relative weight change at 6 months and 1 year for children in the experimental compared to the control group , but these effects were not maintained at 2 years . These results suggest the introduction of mastery criteria and contingent reinforcement for mastery can improve outcome during treatment in behavioral treatments for childhood obesity Adolescents with obesity ( N = 48 ) and their caregivers were r and omized to Multisystemic Therapy ( MST ) or a group weight-loss intervention . MST adolescents significantly reduced percents overweight and body fat , while control adolescents did not . Treatments such as MST that can intervene in the multiple systems that influence weight are worthy of further study We evaluated the efficacy of a 6-month clinic and home-based behavioral intervention ( Learning about Activity and Underst and ing Nutrition for Child Health ; LAUNCH ) to reduce obesity in preschool children ≥95th BMI percentile compared to enhanced st and ard of care ( Pediatrician Counseling ; PC ) . LAUNCH was a family-based behavioral intervention that taught parents to use child behavior management strategies to increase healthy eating and activity for their children and themselves . PC presented the same diet and activity recommendations , but was delivered in a one-time PC session . Eighteen children aged 2 - 5 years ( mean 4.71 ± 1.01 ) with an average BMI percentile of 98 ( ±1.60 ) and an overweight parent were r and omized to LAUNCH or PC . Assessment s were conducted at baseline , 6 months ( end of LAUNCH treatment ) and 12 months ( 6 months following LAUNCH treatment ) . LAUNCH showed a significantly greater decrease on the primary outcomes of child at month 6 ( post-treatment ) BMI z ( -0.59 ± 0.17 ) , BMI percentile ( -2.4 ± 1.0 ) , and weight gain ( -2.7 kg ± 1.2 ) than PC and this difference was maintained at follow-up ( month 12 ) . LAUNCH parents also had a significantly greater weight loss ( -5.5 kg ± 0.9 ) at month 6 and 12 ( -8.0 kg ± 3.5 ) than PC parents . Based on the data from this small sample , an intensive intervention that includes child behavior management strategies to improve healthy eating and activity appears more promising in reducing preschool obesity than a low intensity intervention that is typical of treatment that could be delivered in primary care OBJECTIVE To evaluate the effectiveness and sustainable impact of a multifaceted community-based weight intervention program for children , including exergaming curriculum . METHODS Eighty overweight or obese children , aged 8 - 12 years , were r and omly assigned in a 2:1 ratio to an Exergaming for Health intervention group , comprising both exergaming and classroom curriculum , or to a control group with classroom curriculum alone . Outcome measures included body mass index ( BMI ) , z-score change , and shuttle runs to assess cardiorespiratory endurance . RESULTS Fifty-nine participants took part in the intervention and 21 in the control group , with 35 and 13 completing 6-month follow-up , respectively . Twenty-eight intervention children were followed-up at 1 year . At the end of the 6-month intervention , the intervention group reduced its BMI z-score by -0.06 ( ±0.12 ) compared to 0 ( ±0.09 ) change for the control group ; additionally , intervention subjects were two shuttle runs higher than control . However , these differences were not statistically significant ( P = 0.07 and P = 0.09 , respectively ) . Over the 6-month period after the program , the intervention group did not have an increase in weight status ( BMI z-score change -0.01 [ 95 % confidence interval -0.08 to + 0.06 ] , P = 0.76 ) . CONCLUSIONS Use of exergaming in community pediatric weight management did not improve weight status at the end of programming , and study implementation was limited by small sample and missing data . However , there were clinical ly promising trends in fitness , screen time , and caloric intake . Weight status of intervention participants did not rebound 6 months after programming . Larger , longer term studies are needed to establish the impact of videogaming interventions Project STORY is a 3-arm , r and omized , planning and feasibility study assessing the effectiveness of two behavioral weight management interventions in an important and at-risk population , overweight children and their parents in medically underserved rural counties . Participants will include 90 parent-child dyads from rural counties in north central Florida . Families will be r and omized to one of three conditions : ( a ) a Family-Based Behavioral Group Intervention , ( b ) a Parent-Only Behavioral Group Intervention , and ( c ) a waitlist control condition . Child and parent participants will be assessed at baseline ( month 0 ) , post-treatment ( month 4 ) and follow-up ( month 10 ) . Assessment and intervention sessions will be held at Cooperative Extension offices within each local participating county . The primary outcome measure is change in child body mass index ( BMI ) z-score . Additional key outcome measures include child dietary intake , physical activity , self-esteem , body image , and parent BMI . The goals of the study are to ( a ) assess the feasibility of recruitment in rural setting s , ( b ) develop and evaluate training protocol for group leaders , ( c ) determine strategies to increase adherence to monitoring and goal setting protocol , ( d ) evaluate strategies for participant retention , ( e ) assess the relative cost-effectiveness of the interventions , ( f ) assess the acceptability of the intervention to families and Cooperative Extension administrators and personnel , and ( g ) if successful , estimate the sample size needed for a full-scale trial . This research has potential implication s for medically underserved rural communities with limited re sources and preventive health care services . If successful , a Parent-Only intervention program may provide a cost-effective and practical intervention for families in underserved rural communities BACKGROUND School-based trials to prevent and reduce prevalence of pediatric obesity in low-income countries are necessary . In Brazil , addressing adolescent obesity is a public health priority . OBJECTIVE To evaluate the impact of a group r and omized controlled trial involving a 6-month multicomponent school-based obesity prevention program targeting adolescent girls . METHODS The Healthy Habits , Healthy Girls-Brazil program recruited participants ( n=253 ; 16.05±0.05 years ) from ten eligible public technical schools in São Paulo , Brazil . The program was adapted from an Australian intervention study , which is based on the Social Cognitive Theory . The primary outcome measure was body mass index ( BMI ) , and secondary outcomes included BMI z score , waist circumference , and various sedentary and dietary health-related behaviours . RESULTS Although changes in BMI were not statistically significant , differences favored the intervention group ( adjusted mean difference , -0.26kg/m(2),se SE=0.018 , p=0.076 ) . Statistically significant intervention effects were found for waist circumference ( -2.28 cm ; p= , p=0.01 ) , computer screen time on the weekends ( 0.63h/day , p ; p=0.02 ) , total sedentary activities on the weekends ( -0.92h/day , p<0.01 ) , and vegetable intake ( 1.16servings/day , p=0.01 ) . CONCLUSION These findings provide some evidence for the benefit of a school-based intervention to prevent unhealthy weight gain in adolescent girls living in low-income communities Cardiovascular disease ( CVD ) is the number one cause of death in the United States . Obesity is highly related to CVD risk , especially in African American women . This study explored the efficacy of a culturally specific obesity prevention program . Design ed for low-income , inner-city African American girls and their mothers , the program addressed the importance of eating a low-fat , low-cholesterol diet and increasing activity . Mother-daughter dyads were r and omly assigned to a 12-week treatment or an attention placebo group . Participants were assessed at pre- and posttreatment on dietary intake , including daily fat intake , daily saturated fat intake , percentage of daily calories from fat , and daily cholesterol intake . Results showed significant differences between the treatment and control mothers for daily saturated fat intake and percentage of calories from fat . Differences among treatment and control groups were also noted for the daughters on percentage of daily calories from fat . Implication s of the findings for developing culturally specific health risk reduction programs are discussed OBJECTIVE Lifestyle programs can reduce the level of overweight in children ; however , maintenance results and adherence to treatment are difficult to achieve . New technologies , such as the Short Message Service ( SMS ) , might be a promising tool for enhancing interventions . The effect of an SMS approach aim ed at improving treatment results and reducing dropout rates in a pediatric lifestyle intervention , is explored . METHOD Overweight and obese children ( N = 141 ; age 7 - 12 years ) participating in a lifestyle program were r and omly assigned to an intervention group receiving an SMS Maintenance Treatment ( SMSMT ) for 38 weeks ( n = 73 ) or to a control group receiving no SMSMT ( n = 68 ) . Children were asked to send weekly self-monitoring data on exercise , eating behavior , and emotional well-being . In return , they received tailored feedback messages . A differential decrease in BMI was analyzed with repeated measures ANOVA and dropout with logistic regression analysis . RESULTS We found no significant difference in BMI decrease between the two groups after 12 months ; however , we showed that the SMSMT group had 3.25 times less probability of dropping out after 1 year ( p = .01 ) than controls . In the first 3 months of SMSMT , the SMSMT completers sent 0.80 SMSs per week , which reduced to 0.50 SMSs in the final 3 months . Younger children sent more SMSs ( p = .03 ) . CONCLUSIONS These results indicate that SMSMT is effective in reducing dropout rates from a pediatric lifestyle intervention . Future research should examine the effectiveness of SMSMT on weight management and related psychosocial variables INTRODUCTION There has been a paucity of theory-based interventions to improve health outcomes in overweight adolescents . Therefore , two intervention studies were conducted to : ( a ) determine the feasibility of implementing the Creating Opportunities for Personal Empowerment ( COPE ) Healthy Lifestyles Thinking , Emotions , Exercise , and Nutrition ( TEEN ) program with overweight adolescents ; ( b ) obtain feedback that could be used to refine the program ; and ( c ) examine the preliminary efficacy of the COPE program on the adolescents ' weight and body mass index ( BMI ) . METHOD Phase I and Phase II clinical trials were conducted with 23 overweight teens . The Phase 1 trial used a pre-experimental design with one group of 11 urban adolescents . The Phase 2 trial was conducted with 12 suburban teens using a r and omized controlled pilot study . COPE teens received a 15-session cognitive-behavioral skills building program that included physical activity , while the control group received an attention control program . Weight change and BMI were the key outcomes . RESULTS COPE teens experienced a significantly greater reduction in weight and BMI than did teens in the control group , who gained weight over time . Although the COPE program was well received by all of the teens , retention of subjects across time and parent involvement in the program were challenges in the urban high school . DISCUSSION These studies provide preliminary data to indicate that the implementation of COPE is feasible and may lead to a reduction in weight and BMI in overweight teens . Implementing COPE within the context of the school day may be more successful in sustaining adolescent involvement in the program versus using an after-school format The aims of this study are to examine in children : ( i ) obesity-related alterations in satiety factors such as leptin , ghrelin , and obestatin ; ( ii ) the link between satiety factors and cardiometabolic risk factors ; and ( iii ) the impact of a physical activity-based lifestyle intervention on the levels of these satiety factors in the obese . We studied a total of 21 adolescents ( BMI percentile , 99.0 + /- 0.6 for 15 obese and 56.2 + /- 1.1 for 6 lean ) . The obese subjects underwent a 3-month r and omized controlled physical activity-based lifestyle intervention . Leptin , soluble leptin receptor ( sOB-R ) , ghrelin , and obestatin levels were determined as the primary outcome measures . Other markers of cardiometabolic disease such as inflammation and insulin resistance were also determined . Body composition was measured by dual-energy X-ray absorptiometry . The concentrations of ghrelin , obestatin , and sOB-R were significantly lower in the obese children compared to the lean controls , whereas that of leptin was higher ( all P < 0.05 ) . Although intervention led to a net increase in obestatin ( P < 0.01 ) and no change in ghrelin levels , the balance between ghrelin and obestatin ( ratio of ghrelin to obestatin , G/O ) decreased ( P < 0.02 ) . Intervention reduced leptin and increased sOB-R ( P < 0.01 for both ) . Significant associations between satiety factors and other cardiometabolic risk factors were also observed . Taken together , alterations in the levels of satiety factors are evident early in the clinical course of obesity , but physical activity-based lifestyle intervention either prevented their continued increase or normalized their levels . These beneficial effects appear to aid in the maintenance of body weight and reduction in cardiovascular risk UNLABELLED BACKGROUND ; The increasing prevalence of overweight among children in the United States presents a national health priority . Higher rates of overweight/obesity among minority women place their children at increased risk . Although increased rates of overweight are observed in 4- to 5-year-old children , they are not observed in 2- to 3-year-old children . Therefore , early prevention efforts incorporating families are critical . METHODS The primary aim of Hip-Hop to Health Jr. is to alter the trajectory toward overweight/obesity among preschool African-American and Latino children . This 5-year r and omized intervention is conducted in 24 Head Start programs , where each site is r and omized to either a 14-week dietary/physical activity intervention or a general health intervention . RESULTS This paper presents the rationale and design of the study . Efficacy of the intervention will be determined by weight change for the children and parent/caretaker . Secondary measures include reductions in dietary fat and increases in fiber , fruit/vegetable intake , and physical activity . Baseline data will be presented in future papers . CONCLUSIONS The problem of overweight/obesity is epidemic in the United States . Behaviors related to diet and physical activity are established early in life and modeled by family members . Early intervention efforts addressing the child and family are needed to prevent obesity later in life . This paper describes a comprehensive , family-oriented obesity prevention program for minority preschool children PURPOSE To pilot motivational interviewing ( MI ) targeting weight-related behaviors in African American adolescents with body mass index ≥85th percentile . METHODS A total of 44 adolescents were r and omly assigned to MI or nutrition counseling with baseline and 3-month assessment . RESULTS MI group reported improved eating behaviors and activity motivation . CONCLUSION Brief clinic-based MI interventions merit further study in this population Background Approximately one third of New Zeal and children and young people are overweight or obese . A similar proportion ( 33 % ) do not meet recommendations for physical activity , and 70 % do not meet recommendations for screen time . Increased time being sedentary is positively associated with being overweight . There are few family-based interventions aim ed at reducing sedentary behavior in children . The aim of this trial is to determine the effects of a 24 week home-based , family oriented intervention to reduce sedentary screen time on children 's body composition , sedentary behavior , physical activity , and diet . Methods / Design The study design is a pragmatic two-arm parallel r and omized controlled trial . Two hundred and seventy overweight children aged 9 - 12 years and primary caregivers are being recruited . Participants are r and omized to intervention ( family-based screen time intervention ) or control ( no change ) . At the end of the study , the control group is offered the intervention content . Data collection is undertaken at baseline and 24 weeks . The primary trial outcome is child body mass index ( BMI ) and st and ardized body mass index ( z BMI ) . Secondary outcomes are change from baseline to 24 weeks in child percentage body fat ; waist circumference ; self-reported average daily time spent in physical and sedentary activities ; dietary intake ; and enjoyment of physical activity and sedentary behavior . Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity . Discussion This study provides an excellent example of a theory-based , pragmatic , community-based trial targeting sedentary behavior in overweight children . The study has been specifically design ed to allow for estimation of the consistency of effects on body composition for Māori ( indigenous ) , Pacific and non-Māori/non-Pacific ethnic groups . If effective , this intervention is imminently scalable and could be integrated within existing weight management programs . Trial Registration Objective : We investigated the long-term efficacy of two childhood obesity treatment programs , routine counselling ( two appointments for children ) and group treatment ( 15 sessions separately for children and parents ) in a r and omised controlled trial . As published earlier , group treatment was more effective than routine counselling in the treatment of 7–9 year-old obese children in the short term . Design : The children 's heights and weights were measured 2 and 3 years after the beginning of the intervention and changes in weight for height , body mass index ( BMI ) and BMI st and ard deviation scores were used as outcome measures . Results : There were no significant differences between the treatment arms in the changes of outcome measures from baseline to 2- or 3-years follow-up visits . Conclusion : In conclusion , novel efforts are needed for the improvement of the long-term results of childhood obesity treatment programs BACKGROUND Latino preschool children in the United States are at high risk for obesity . The objective of this study was to measure over a one-year period whether a parent training based on social learning theory combined with evidence -based interventions to promote optimal nutrition and physical activity will reduce the upward trend of BMI z-scores in groups of 2–4 year old Latino children living in low-income households . METHODS Seven weekly classes with 2 booster classes were delivered to low-income Latino parents with 2–4 year old children . A r and omized controlled pilot study evaluated the effectiveness of the intervention that contrasts 61 children whose parents were r and omized to receive Parent Training ( PT ) with 60 Wait-list ( WL ) subjects . Forty subjects did not attend the one-year follow up assessment , result ing in 81 subjects who have measurements for both baseline and one-year follow up assessment s. To adjust for differential dropout rates and missing observations , imputation of missing data was done using a carefully constructed model that included relevant independent variables . RESULTS There were no significant subject differences between groups at baseline for family characteristics and BMI categories for child and parent . Children in the intervention group decreased their BMI z-scores significantly on average by .20 ( SE= .08 ) compared to children in the control group who increased z scores on average by .04 ( SE=.09 ) at one year ( P<.05 ) . CONCLUSIONS Parent training is effective to reduce the risk of overweight in preschool Latino children living in low-income households . The findings need to be examined in a larger sample of children OBJECTIVE To assess the effectiveness of parent-only vs family-based interventions for pediatric weight management in underserved rural setting s. DESIGN A 3-arm r and omized controlled clinical trial . SETTING All sessions were conducted at Cooperative Extension Service offices in underserved rural counties . PARTICIPANTS Ninety-three overweight or obese children ( 8 - 14 years old ) and their parent(s ) . INTERVENTION Families were r and omized to ( 1 ) a behavioral family-based intervention , ( 2 ) a behavioral parent-only intervention , or ( 3 ) a wait-list control group . OUTCOME MEASURE The primary outcome measure was change in children 's st and ardized body mass index ( BMI ) . RESULTS Seventy-one children completed posttreatment ( month 4 ) and follow-up ( month 10 ) assessment s. At the month 4 assessment , children in the parent-only intervention demonstrated a greater decrease in BMI z score ( mean difference [ MD ] , 0.127 ; 95 % confidence interval [ CI ] , 0.027 to 0.226 ) than children in the control condition . No significant difference was found between the family-based intervention and the control condition ( MD , 0.065 ; 95 % CI , -0.027 to 0.158 ) . At month 10 follow-up , children in the parent-only and family-based intervention groups demonstrated greater decreases in BMI z score from before treatment compared with those in the control group ( MD , 0.115 ; 95 % CI , 0.003 to 0.220 ; and MD , 0.136 ; 95 % CI , 0.018 to 0.254 , respectively ) . No difference was found in weight status change between the parent-only and family-based interventions at either assessment . CONCLUSIONS A parent-only intervention may be a viable and effective alternative to family-based treatment of childhood overweight . Cooperative Extension Service offices have the potential to serve as effective venues for the dissemination of obesity-related health promotion programs OBJECTIVE To assess the effects of a multidisciplinary intervention program for 3-year-old to 5-year-old overweight and obese children compared with a usual-care program . DESIGN R and omized controlled clinical trial conducted from October 2006 to March 2008 . SETTING Groningen Expert Center for Kids with Obesity at Beatrix Children 's Hospital , University Medical Center Groningen . PARTICIPANTS Seventy-five children ( 29 overweight , 46 obese ) aged 3 to 5 years . INTERVENTION A multidisciplinary intervention program vs a usual-care program . Anthropometry was performed and body composition was determined by bioelectrical impedance analysis and ultrasonography at the start and end of the 16-week program and 12 months after starting the intervention . MAIN OUTCOME MEASURES The actual weight reduction , change in body mass index ( BMI , calculated as weight in kilograms divided by height in meters squared ) , BMI z score , body fat percentage , and visceral fat in the multidisciplinary intervention group compared with a usual-care group . RESULTS At the end of the treatment program , children in the multidisciplinary intervention group showed a greater decrease in BMI , BMI z score , and waist circumference z score compared with children in the usual-care group . At 12 months , children in the intervention group showed greater decreases in BMI , BMI z score , waist circumference , and waist circumference z score compared with children in the usual-care group . Visceral fat showed a trend toward a higher decrease . CONCLUSIONS A multidisciplinary intervention program in 3-year-old to 5-year-old overweight and obese children had beneficial effects on anthropometry and body composition . The positive effects were still present 12 months after the start of the intervention . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N47185691 Objective : The aims of this study were to describe the dietary intakes and food behavior changes of overweight and obese children participating in the Hunter Illawarra Kids Challenge Using Parent Support ( HIKCUPS ) study and to describe the impact of a best practice dietary modification program . Design : A multicenter r and omized controlled trial with allocation to one of three intervention arms : ( 1 ) parent-centered nutrition lifestyle program ; ( 2 ) child-centered physical activity skill development program ; or ( 3 ) both the programs . Participants : One hundred and sixty-five overweight , pre-pubertal children 5–9 years of age ( 58 % female ) . Measurements : Dietary intake was assessed at baseline , 6 and 12 months post-commencement of the program using a semiquantitative food frequency question naire . Results : After 6 and 12 months , all groups improved their dietary intake , with no differences detected between groups ( P>0.05 ) . Total quantity of food ( g ) and kJ kg−1 decreased significantly at both time points ( P<0.05 ) . Percent energy derived from core food groups , except fruit , increased significantly at 12 months compared to baseline ( P<0.05 ) , and non-core foods decreased , with the largest decreases being for sweetened drinks ( 5.0±0.4 vs 2.9±0.3 % of energy baseline to 12 months , P<0.001 ) and packaged lunch box snacks ( 5.4±0.3 vs 4.1±0.3 % of energy baseline to 12 months , P<0.001 ) . Conclusion : All treatment groups in the HIKCUPS study appear to be equally efficacious in improving dietary intake in overweight and obese children This paper reports the final 24-month outcomes of a r and omized controlled trial evaluating the effect of additional therapeutic contact ( ATC ) as an adjunct to a community-based weight-management program for overweight and obese 13–16-year-olds . ATC involved telephone coaching or short-message-service and /or email communication once per fortnight . Adolescents were r and omized to receive the Loozit group program — a two-phase behavioral lifestyle intervention with ( n=73 ) , or without ( n=78 ) , ATC in Phase 2 . Adolescents/parents separately attended seven weekly group sessions ( Phase 1 ) , followed by quarterly adolescent sessions ( Phase 2 ) . Assessor-blinded , 24-month changes in anthropometry and metabolic health included primary outcomes body mass index ( BMI ) z-score and waist : height ratio ( WHtR ) . Secondary outcomes were self-reported psychosocial and lifestyle changes . By 24 months , 17 adolescents had formally withdrawn . Relative to the Loozit program alone , ATC largely had no impact on outcomes . Secondary pre-post assessment of the Loozit group program showed mean ( 95 % CI ) reductions in BMI z-score ( −0.13 ( −0.20 , −0.06 ) ) and WHtR ( −0.02 ( −0.03 , −0.01 ) ) in both arms , with several metabolic and psychosocial improvements . Adjunctive ATC did not provide further benefits to the Loozit group program . We recommend that further work is needed to optimize technological support for adolescents in weight-loss maintenance . Australian New Zeal and Clinical Trials Registry Number ACTRNO12606000175572 OBJECTIVE To evaluate associations between parent behaviors ( i.e. , parent weight change , self-monitoring of their behavior , and feeding practice s and attitudes ) and changes in adolescent BMI and weight following 16-weeks of behavioral weight control ( BWC ) intervention . METHOD Adolescents ( N = 86 ) 13 - 16 years old and 30 - 90 % overweight ( M = 60.54 % , SD = 15.10 % ) who completed BWC intervention and their parents . Adolescents were r and omized to 1 of 2 interventions involving 16 consecutive weeks of active treatment with 4 biweekly maintenance sessions . Adolescent weight and BMI were measured at baseline and 16-weeks . Feeding practice s were measured at baseline . Parent self-monitoring was measured during the intervention . RESULTS The only independently significant predictor of adolescent BMI change ( p < .01 ) was parent BMI change . Greater parent self-monitoring ( p < .01 ) predicted greater adolescent weight loss . Greater parent pressure to eat predicted less adolescent weight loss ( p < .01 ) . CONCLUSIONS Findings highlight the potential importance of parent weight-related behaviors and feeding practice s in the context of adolescent BWC OBJECTIVE To examine the efficacy of an adjunct motivational and autonomy-enhancing intervention ( self-directed ) for behavioral family-based pediatric obesity relative to the st and ard prescription of uniform behavioral skills use and interventionist goal assignment ( prescribed ) . METHODS In this r and omized clinical trial , 72 overweight/obese children and their parents/caregivers were assigned to either self-directed or prescribed intervention for 20 weeks , with approaches diverging after week 5 . Anthropometric measurements from child and participating parent at baseline , posttreatment , and 3-month , 6-month , 1-year , and 2-year follow-ups were evaluated for change ( n = 59 in follow-up analyses ) . RESULTS The approaches demonstrated similar child body mass index ( BMI ) z-score and parent BMI change from baseline to posttreatment and throughout follow-up , with child and parent weight status lower than baseline at 2 years after treatment cessation . CONCLUSIONS An adjunct motivational and autonomy-enhancing approach to behavioral family-based pediatric obesity treatment is a viable alternative to the st and ard intervention approach OBJECTIVE This study evaluated the feasibility , acceptability , and initial efficacy of an intervention based on Schachter 's externality theory ; the Regulation of Cues ( ROC ) program . METHODS 44 overweight and obese 8 - 12-year-old children and their parents were r and omly assigned to a 4-month ROC program or the control group . Outcomes were assessed at baseline , posttreatment , and 4 months posttreatment and included acceptability and feasibility , body weight , and eating behaviors . RESULTS The ROC program had moderate to high acceptability ratings . Significant improvements were found for the ROC group compared with the control group on child food responsiveness at posttreatment and eating in the absence of hunger at 4 months posttreatment . Improvements were seen for the ROC group compared with the control group on body weight measures and food responsiveness , although these only approached significance . CONCLUSION The ROC intervention may be useful with overweight and obese children . Larger , fully powered studies are needed to further evaluate the efficacy of this model BACKGROUND Mobile technologies have wide-scale reach and disseminability , but no known studies have examined mobile technologies as a st and -alone tool to improve obesity-related behaviors of at-risk youth . PURPOSE To test a 12-week mobile technology intervention for use and estimate effect sizes for a fully powered trial . METHODS Fifty-one low-income , racial/ethnic-minority girls aged 9 - 14 years were r and omized to a mobile technology ( n=26 ) or control ( n=25 ) condition . Both conditions lasted 12 weeks and targeted fruits/vegetables ( FVs ; Weeks 1 - 4 ) ; sugar-sweetened beverages ( SSBs ; Weeks 5 - 8 ) , and screen time ( Weeks 9 - 12 ) . The mobile intervention prompted real-time goal setting and self-monitoring and provided tips , feedback , and positive reinforcement related to the target behaviors . Controls received the same content in a written manual but no prompting . Outcomes included device utilization and effect size estimates of FVs , SSBs , screen time , and BMI . Data were collected and analyzed in 2011 - 2012 . RESULTS Mobile technology girls used the program on 63 % of days and exhibited trends toward increased FVs ( + 0.88 , p=0.08 ) and decreased SSBs ( -0.33 , p=0.09 ) . The adjusted difference between groups of 1.0 servings of FVs ( p=0.13 ) and 0.35 servings of SSBs ( p=0.25 ) indicated small to moderate effects of the intervention ( Cohen 's d=0.44 and -0.34 , respectively ) . No differences were observed for screen time or BMI . CONCLUSIONS A st and -alone mobile app may produce small to moderate effects for FVs and SSBs . Given the extensive reach of mobile devices , this pilot study demonstrates the need for larger-scale testing of similar programs to address obesity-related behaviors in high-risk youth BACKGROUND Cost-effectiveness analyses facilitate the allocation of health care re sources . The aim of the study was to compare the cost-effectiveness of group treatment , already known to be more effective , with routine counseling in obese children . METHOD A prospect i ve 6-month intervention assessed family-based group treatment ( 15 separate sessions for parents and children ) and routine counseling ( two appointments for children ) . Children 's weights and heights were measured at baseline , at the end of the intervention and at follow up 6 months later , and the changes in weight for height and body mass index st and ard deviations scores ( BMI -SDS ) were calculated and used as main outcome measures . The mean costs and effects of the programs were analyzed to produce the incremental cost-effectiveness ratio , which is an estimate of the additional costs per 1 % decrease in weight for height or 0.1 decrease in BMI -SDS . Cost-effectiveness analysis was performed from the perspective of the service provider . RESULTS At the end of the intervention , group treatment costs were 1.4-fold ( non-calculable 6 months later ) when counted per 1 % weight for height decrease , and 3.5-fold ( 2.8-fold 6 months later ) when counted per 0.1 BMI -SDS decrease . Incremental cost-effectiveness ratio estimates were euro 53 when calculated for 1 % weight for height decrease , and euro 266 ( euro 275 6 months later ) when calculated for 0.1 BMI -SDS decrease . CONCLUSIONS Family-based group treatment is more costly compared with individual routine counseling . Salaries form most of the total costs Diogenes is a Pan-European , r and omized , controlled dietary intervention study investigating the effects of dietary protein and glycaemic index on weight (re)gain , metabolic and cardiovascular risk factors in obese and overweight families in eight European centres . The article is method ological in character , and the presentation of ' results ' will be limited to baseline characteristics of the study population s included . A total of 891 families with at least one overweight/obese parent underwent screening . The parents started an initial 8-week low-calorie diet and families with minimum one parent attaining a weight loss of > or = 8 % , were r and omized to one of five energy ad libitum , low-fat ( 25 - 30 E% ) diets for 6 or 12 months : low protein/low glycaemic index , low protein/high glycaemic index , high protein/low glycaemic index , high protein/high glycaemic index or control ( national dietary guidelines ) . At two centres the families were provided dietary instruction plus free foods for 6 months followed by 6-month dietary instruction only . At the remaining six centres the families received dietary instruction only for 6 months . The median weight loss during the low-calorie diet was 10.3 kg ( inter-quartile range : 8.7 - 12.8 kg , n = 775 ) . A total of 773 adults and 784 children were r and omized to the 6-month weight (re)gain prevention phase . Despite major cultural and dietary regional differences in Europe , interventions addressing effects of dietary factors are feasible with a reasonable attrition BACKGROUND Physical activity-induced reduction in obesity-related hyperfibrinogenemia in children has been reported . The underlying mechanisms remain elusive . Further , the effect of such interventions on fibrinolysis in children is scarce . OBJECTIVES To investigate in obese children , before and after a physical activity-based intervention : ( i ) the mechanistic role of fractional synthesis rate ( FSR ) of fibrinogen in the reduction of hyperfibrinogenemia ; and ( ii ) the changes in fibrinolytic factors . METHODS Subjects included 21 ( age > 14 < 18 years ; Tanner stage , IV-V ) children ( 15 obese , BMI > 95%tile for age and sex and six lean , BMI < 85%tile ) . After baseline measurements of FSR of fibrinogen , and concentrations of fibrinogen , D-dimer , PAI-1 and t-PA in all children , studies were repeated after a 3-month r and omized controlled physical activity-based lifestyle intervention in obese children only . RESULTS FSR of fibrinogen was higher ( P = 0.002 ) in the obese ( vs. lean ) group , which was reduced ( P = 0.001 ) after intervention . This almost completely accounted for the reduction in obesity-related hyperfibrinogenemia . High levels of D-dimer decreased ( P = 0.001 ) after intervention , whereas fibrinolysis was not enhanced . CONCLUSIONS The direct reduction in the FSR of fibrinogen and the remarkable correlation between the magnitudes of reduction in fibrinogen FSR and concentration signify a mechanistic role for FSR in the regulation of physical activity-induced reversal of hyperfibrinogenemia in obese children . The congruent reductions in the FSR of fibrinogen and the concentrations of fibrinogen and D-dimer in response to intervention despite depressed fibrinolysis suggest an overall improvement in the hypercoagulable state in obese children with physical activity-based lifestyle intervention BACKGROUND University – community partnerships through coordinated school health programs ( CSHP ) can play a key role in decreasing child obesity . The main objective of this study was to measure over a 1-year period whether a CSHP with parental , school , and home-based components to promote optimal nutrition will reduce BMI percentiles and z-scores and improve dietary behaviors in a sample of low-income , school-aged children . METHODS The intervention included , Kids Nutrition and Fitness , a 6-week nutrition , physical activity educational after-school program , and school activities , including creation of an Advisory Committee that made wellness policies . A r and omized controlled pilot study evaluated the effectiveness of the intervention that contrasts 251 ( n = 251 ) predominantly Mexican-American 8 to 12 year olds from low-income Los Angeles – based schools . A mixed model of repeated measures analysis assessed changes in BMI percentiles and z-scores , dietary behaviors , food preferences , knowledge , and self-efficacy measured by a reliable/valid question naire . These data were collected at baseline and at 4 and 12 months postintervention . Process measures , collected via focus groups with parents , evaluated parent/community involvement . RESULTS At the 12-month follow-up , children in the intervention group decreased their BMI on average by 2.80 ( p = 0.04 ) and BMI z-scores on average by 0.48 ( p = 0.03 ) and they increased their daily dietary intake of vegetables on average by 1.51 ( p = 0.03 ) , fruit on average by 2.00 ( P = 0.001 ) , and 100 % fruit juice by 1.12 ( p = 0.05 ) . An increase of 1.02 ( p = 0.03 ) was seen in self-efficacy of healthy food choices ( p = 0.03 ) . Parent ( P = 0.04 ) and community ( p = 0.001 ) involvement significantly increased to 100 % participation by the 12-month follow-up . CONCLUSIONS A CSHP using parent and community involvement was effective in reducing the risk of obesity in school-aged Mexican- American children attending low-income schools . The findings need to be examined in a larger , more diverse sample of children OBJECTIVE To examine adolescent and facilitator participation in the first 10 months of an obesity management intervention including electronic contact ( e-contact ) via e-mail and short message service ( SMS ) communication . MATERIAL S AND METHODS Participants ( n=49 ) were overweight and obese ( 13 - 16 year olds ) and were r and omized to receive e-contact in the Loozit trial . Adolescents were sent brief , semipersonalized health messages approximately monthly , from 2 to 12 months . We analyzed adolescents ' response patterns , reply content , satisfaction with e-contact intervention , and facilitator responsiveness . Two coding systems described the general attributes and content of adolescent replies and facilitator responses . RESULTS Adolescents ' overall reply rate was 22 % . There was no difference in age , sex , socioeconomic status , body mass index z-score , or initial group program attendance between the 27 adolescents who replied to 0 - 2 messages and the 22 who replied to > or=3 messages . Adolescent SMS replies had less characters and a quicker response time compared with e-mail replies . Adolescent responses were largely relevant to initial health messages sent ( 91 % ) , with few using " SMS language " ( 17 % ) or emoticons ( 7 % ) . Most adolescents rated e-contact as " somewhat helpful . " Facilitators responded to 93 % of adolescent replies , and most responses were personalized ( 93 % ) , encouraging ( 88 % ) , and educational ( 75 % ) . CONCLUSIONS Although adolescent engagement was modest , SMS and e-mail communication is a feasible and acceptable adjunct to group lifestyle intervention and telephone coaching in overweight and obese adolescents . Healthy eating messages and those concluding with " please reply " elicited the highest reply rates , and thus these message types should be included in future adolescent e-contact interventions BACKGROUND & AIMS Few studies evaluating treatment of adolescent obesity have been published . Therefore , long-term effects of the Go4it group treatment for obese adolescents were examined . METHODS Obese adolescents ( 11 - 18 years ) visiting an outpatient paediatric obesity clinic were r and omly assigned to 1 ) intervention group ( Go4it ) or 2 ) current regular care i.e. referral to a dietician in the home care setting ( controls ) . Linear mixed models analysis was performed to evaluate intervention effects . Effect modification by sex , age and ethnicity was checked . Outcome measures included body mass index st and ard deviation score ( BMI sds ) , body composition and metabolic components at 6 and 18 months follow-up . RESULTS 122 adolescents , 71 Go4it and 51 controls , with a mean BMI sds of 2.9 ± 0.5 were r and omised . At 18 months a modest significant reduction in BMI sds ( between group difference : -0.16 ; 95%CI : -0.30 , -0.02 ; p = .028 ) was observed . None of the other body composition or metabolic components showed significant treatment effects . Ethnicity was a significant effect modifier . Posthoc analysis showed a large significant reduction on BMI sds ( between group difference : -0.35 ; 95%CI : -0.64 , -0.07 ) at 18 months for obese adolescents from western descent , while no effect was observed for adolescents from non-western descent . Significant treatment effects were also observed for systolic and diastolic blood pressure , as well as HDL cholesterol level , but only for obese adolescents from western descent . CONCLUSIONS Go4it showed promising long-term effects on BMI sds compared with regular care in obese adolescents . Larger benefits were achieved for adolescents of western ethnicity . This trial was registered at www.trialregister.nl with the Netherl and s Trial Register as IS RCT N27626398 Objective To determine whether general practice surveillance for childhood obesity , followed by obesity management across primary and tertiary care setting s using a shared care model , improves body mass index and related outcomes in obese children aged 3 - 10 years . Design R and omised controlled trial . Setting 22 family practice s ( 35 participating general practitioners ) and a tertiary weight management service ( three paediatricians , two dietitians ) in Melbourne , Australia . Participants Children aged 3 - 10 years with body mass index above the 95th centile recruited through their general practice between July 2009 and April 2010 . Intervention Children were r and omly allocated to one tertiary appointment followed by up to 11 general practice consultations over one year , supported by shared care , web based software ( intervention ) or “ usual care ” ( control ) . Research ers collecting outcome measurements , but not participants , were blinded to group assignment . Main outcome measures Children ’s body mass index z score ( primary outcome ) , body fat percentage , waist circumference , physical activity , quality of diet , health related quality of life , self esteem , and body dissatisfaction and parents ’ body mass index ( all 15 months post-enrolment ) . Results 118 ( 60 intervention , 56 control ) children were recruited and 107 ( 91 % ) were retained and analysed ( 56 intervention , 51 control ) . All retained intervention children attended the tertiary appointment and their general practitioner for at least one ( mean 3.5 ( SD 2.5 , range 1 - 11 ) ) weight management consultation . At outcome , children in the two trial arms had similar body mass index ( adjusted mean difference −0.1 ( 95 % confidence interval −0.7 to 0.5 ; P=0.7 ) ) and body mass index z score ( −0.05 ( −0.14 to 0.03 ) ; P=0.2 ) . Similarly , no evidence was found of benefit or harm on any secondary outcome . Outcomes varied widely in the combined cohort ( mean change in body mass index z score −0.20 ( SD 0.25 , range −0.97 - 0.47 ) ; 26 % of children resolved from obese to overweight and 2 % to normal weight . Conclusions Although feasible , not harmful , and highly rated by both families and general practitioners , the shared care model of primary and tertiary care management did not lead to better body mass index or other outcomes for the intervention group compared with the control group . Improvements in body mass index in both groups highlight the value of untreated controls when determining efficacy . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12608000055303 BACKGROUND Screen time , defined as time spent watching television , DVDs , or videos or playing computer or video games , has been related to serious health consequences in children , such as impaired language acquisition , violent behaviour , tobacco smoking and obesity . Our aim was to determine if a simple intervention aim ed at preschool-aged children , applied at the health maintenance visits , in the primary care setting , would be effective in reducing screen time . METHODS We used a two group r and omized controlled trial design . Two- to 6-year-old children and their parents were r and omly assigned to receive an intervention to reduce their screen time , BMI and parental report of aggressive behaviour . At the end of the intervention we made home visits at 2 , 6 and 9 months and the parents completed question naire . RESULTS Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores . CONCLUSIONS This study shows that a preschool-based intervention can lead to reductions in young children 's television/video viewing OBJECTIVE : Early weight change is associated with overall weight loss treatment response in adults but has been relatively unexplored in youth . We investigated the importance of early weight change in a pediatric weight control trial . METHODS : Overweight children aged 7 to 12 years ( n = 204 ) participated in a r and omized controlled trial of 2 weight maintenance treatments ( MTs ) after a 20-week family-based behavioral weight loss treatment ( FBT ) . Hierarchical regression was used to investigate the relation between children 's percentage weight change at sessions 4 , 6 , and 8 of FBT and BMI z-score reductions after FBT and at the 2-year follow-up . Correlations and hierarchical regression were used to identify child and parent factors associated with children 's early weight change . RESULTS : Children 's percentage weight change by FBT session 8 was the best predictor of BMI z-score reductions after FBT and at 2-year follow-up . Percentage weight change in children at session 8 was associated with better FBT attendance and with greater percentage weight change in parents at FBT session 8 . CONCLUSIONS : Early weight change seems to be related to treatment response through the end of treatment and 2-year follow-up . Future research should include investigation of strategies to promote early weight change in children and parents and identification of mechanisms through which early weight change is related to overall treatment response Basic research has shown that increasing variety increases energy intake , and repeated consumption of the same food increases habituation to those foods and reduces consumption . Twenty-four families with overweight/obese 8 - 12 year-old children and overweight/obese parents were r and omly assigned to 6months of usual family based treatment ( FBT ) or FBT plus reduced variety of high energy-dense foods ( FBT+Variety ) . Intention to treat mixed model ANOVA showed between group differences in child percent overweight ( FBT+Variety-15.4 % vs. FBT-8.9 % , p=0.017 ) and parent BMI ( FBT+Variety-3.7kg/m(2 ) vs. FBT-2.3kg/m(2 ) ; p=0.017 ) . Positive relationships were observed between child z BMI and parent BMI changes ( r=0.51 , p=0.018 ) , and between reductions in food variety of high energy-dense foods and reductions in child z BMI ( r=0.54 , p=0.02 ) and parent BMI ( r=0.45 , p=0.08 ) . These pilot data suggest that reducing the variety of high energy dense foods and repeating meals within the context of FBT result ed in improved child and parent weight changes at six months . This represents easy to implement changes that reduce choice and may reduce response burden on families . Reducing variety may be a complement to st and ard FBT that enhances weight loss . Long term studies are needed to assess maintenance of these changes Background Community-based interventions are needed to reduce the burden of childhood obesity . Purpose To evaluate the impact of a multi-level promotora-based ( Community Health Advisor ) intervention to promote healthy eating and physical activity and prevent excess weight gain among Latino children . Methods Thirteen elementary schools were r and omized to one of four intervention conditions : individual/family level ( Family-only ) , school/community level ( Community-only ) , combined ( Family + Community ) , or a measurement-only condition . Participants were 808 Latino parents and their children enrolled in kindergarten through 2nd grade . Measures included parent and child body mass index ( BMI ) and a self-administered parent survey that assessed several parent and child behaviors . Results There were no significant intervention effects on children ’s BMI z-score . The family intervention changed several obesity-related child behaviors ( e.g. , fruit/vegetable consumption ) and these were mediated by changes in parenting variables ( e.g. , parent monitoring ) . Conclusion A promotora-based behavioral intervention was efficacious at changing parental factors and child obesity-related health behaviors Abstract Introduction : Obesity has become the most common modern pediatric chronic disease . Early prevention and treatment of childhood and adolescent obesity is m and ated . Severe obesity [ body mass index ( BMI ) percentile > 98 % ] reduces the likelihood of the multidisciplinary childhood obesity program to succeed , suggesting , most probably , that a more intense program is needed to treat severely obese children . Objective and methods : To prospect ively examine the effects of an intense , 3-month , combined dietary-behavioral-physical activity intervention on anthropometric measures , leisure time activity patterns , and fitness in prepubertal severely obese ( BMI percentile > 98 % ) children ( n=22 ) compared to age , gender , and obesity matched controls ( n=18 ) . Results : At 3 months , there were significant differences ( p<0.05 ) in changes in body weight ( –0.5±2.4 vs. 1.7±1.9 kg ) , BMI ( –0.9±1.2 vs. 0.4±1.0 kg/m2 ) , BMI percentile ( 0.39±0.39 % vs. –0.04±0.32 % ) , sum skinfolds ( –3.1±8.1 vs. 1.1±4.7 mm ) , total habitual physical activity ( 25.4±10.8 vs. 0.3±10.1 Mets ) , and fitness ( 142±72 vs. –8±88 s ) in the intervention vs. control participants . Conclusions : Our data demonstrate the beneficial , short-term effects of an intense combined dietary-behavioral-physical activity intervention on anthropometric measures , activity patterns , and fitness in severely obese children . However , despite the encouraging results , the modest effect on BMI percentiles emphasizes the difficulty of treating severely obese children using the conventional nutritional-behavioral-physical activity approach |
1,366 | 29,165,173 | Conclusion Forest therapy may play an important role in health promotion and disease prevention . | Background Numerous studies have reported that spending time in nature is associated with the improvement of various health outcomes and well-being .
This review evaluated the physical and psychological benefits of a specific type of exposure to nature , forest therapy . | Objective To summarize the evidence for curative and health enhancement effects through forest therapy and to assess the quality of studies based on a review of r and omized controlled trials ( RCTs ) . Study design A systematic review based on RCTs . Methods Studies were eligible if they were RCTs . Studies included one treatment group in which forest therapy was applied . The following data bases – from 1990 to November 9 , 2010 – were search ed : MEDLINE via PubMed , CINAHL , Web of Science , and Ichushi- Web . All Cochrane data bases and Campbell Systematic Review s were also search ed up to November 9 , 2010 . Results Two trials met all inclusion criteria . No specific diseases were evaluated , and both studies reported significant effectiveness in one or more outcomes for health enhancement . However , the results of evaluations with the CONSORT ( Consoli date d St and ards of Reporting Trials ) 2010 and CLEAR NPT ( A Checklist to Evaluate a Report of a Nonpharmacological Trial ) checklists generally showed a remarkable lack of description in the studies . Furthermore , there was a problem of heterogeneity , thus a meta- analysis was unable to be performed . Conclusion Because there was insufficient evidence on forest therapy due to poor method ological and reporting quality and heterogeneity of RCTs , it was not possible to offer any conclusions about the effects of this intervention . However , it was possible to identify problems with current RCTs of forest therapy , and to propose a strategy for strengthening study quality and stressing the importance of study feasibility and original check items based on characteristics of forest therapy as a future research agenda Objective To compare the pain-reducing effect of forest bathing alone versus forest bathing in combination with stretching and strengthening exercises in patients with chronic posterior neck pain . Methods Sixty-four subjects with posterior neck pain that had lasted more than 3 months were enrolled . They were r and omly divided into a forest bathing alone ( FBA ) group and a forest bathing with exercise ( FBE ) group ; each group included 32 subjects . All subjects from both groups walked every morning in the forest for about 2 hours for 5 days . In the afternoon , the FBE group did a stretching and strengthening exercise for about 4 hours ; the FBA group had free time in the woods . Visual analog scale ( VAS ) on one day , VAS over the previous week , neck disability index ( NDI ) , EuroQol 5D-3L VAS ( EQ VAS ) and index ( EQ index ) , McGill pain question naire ( MPQ ) , the number of trigger points in the posterior neck region ( TRPs ) , and the range of motion of the cervical spine were evaluated on the first and last day of the program and compared between the two groups . Results The number of TRPs were significantly reduced in the FBE group compared with the FBA group ( p=0.013 ) . However , the other scales showed no significant difference between the two groups . Conclusion When patients with chronic posterior neck pain underwent a short-term forest bathing ( less than 7 days ) program , FBE was more effective in the reduction of the number of TRPs than FBA . However , all other pain measurement scales we evaluated showed no statistically significant difference between the two protocol OBJECTIVE To provide scientific evidence supporting the efficacy of forest bathing as a natural therapy for human hypertension . METHODS Twenty-four elderly patients with essential hypertension were r and omly divided into two groups of 12 . One group was sent to a broad-leaved evergreen forest to experience a 7-day/7-night trip , and the other was sent to a city area in Hangzhou for control . Blood pressure indicators , cardiovascular disease-related pathological factors including endothelin-1 , homocysteine , renin , angiotensinogen , angiotensin II , angiotensin II type 1 receptor , angiotensin II type 2 receptor as well as inflammatory cytokines interleukin-6 and tumor necrosis factor α were detected . Meanwhile , profile of mood states ( POMS ) evaluation was used to assess the change of mood state of subjects . In addition , the air quality in the two experimental sites was monitored during the 7-day duration , simultaneously . RESULTS The baselines of the indicators of the subjects were not significantly different . Little alteration in the detected indicators in the city group was observed after the experiment . While subjects exposed to the forest environment showed a significant reduction in blood pressure in comparison to that of the city group . The values for the bio-indicators in subjects exposed to the forest environment were also lower than those in the urban control group and the baseline levels of themselves . POMS evaluation showed that the scores in the negative subscales were lowered after exposure to the forest environment . Besides , the air quality in the forest environment was much better than that of the urban area evidence d by the quantitative detection of negative ions and PM10 ( particulate matter < 10 μm in aerodynamic diameter ) . CONCLUSION Our results provided direct evidence that forest bathing has therapeutic effects on human hypertension and induces inhibition of the renin-angiotensin system and inflammation , and thus inspiring its preventive efficacy against cardiovascular disorders Forest bathing trip is a short , leisurely visit to forest . In this study we determined the health effects of forest bathing trip on elderly patients with chronic obstructive pulmonary disease ( COPD ) . The patients were r and omly divided into two groups . One group was sent to forest , and the other was sent to an urban area as control . Flow cytometry , ELISA , and profile of mood states ( POMS ) evaluation were performed . In the forest group , we found a significant decrease of perforin and granzyme B expressions , accompanied by decreased levels of pro-inflammatory cytokines and stress hormones . Meanwhile , the scores in the negative subscales of POMS decreased after forest bathing trip . These results indicate that forest bathing trip has health effect on elderly COPD patients by reducing inflammation and stress level BACKGROUND Psycho-oncological care , including spiritual care , is essential for cancer patients . Integrated medicine , a therapy combining modern western medicine with various kinds of complementary and alternative medicine , can be appropriate for the spiritual care of cancer because of the multidimensional characteristics of the spirituality . In particular , therapies that enable patients to establish a deeper contact with nature , inspire feelings of life and growth of plants , and involve meditation may be useful for spiritual care as well as related aspects such as emotion . The purpose of the present study was to examine the effect of spiritual care of cancer patients by integrated medicine in a green environment . METHODS The present study involved 22 cancer patients . Integrated medicine consisted of forest therapy , horticultural therapy , yoga meditation , and support group therapy , and sessions were conducted once a week for 12 weeks . The spirituality ( the Functional Assessment of Chronic Illness Therapy-Spiritual well-being ) , quality of life ( Short Form-36 Health Survey Question naire ) , fatigue ( Cancer Fatigue Scale ) , psychological state ( Profile of Mood States , short form , and State-Trait Anxiety Inventory ) and natural killer cell activity were assessed before and after intervention . RESULTS In Functional Assessment of Chronic Illness Therapy-Spiritual well-being , there were significant differences in functional well-being and spiritual well-being pre- and postintervention . This program improved quality of life and reduced cancer-associated fatigue . Furthermore , some aspects of psychological state were improved and natural killer cell activity was increased . CONCLUSIONS It is indicated that integrated medicine performed in a green environment is potentially useful for the emotional and spiritual well-being of cancer patients BACKGROUND Clinical trials have not been reported concerning the health benefits of viewing indoor plants on stress and recovery of surgical patients within a hospital setting . Using various medical and psychologic measurements , this study performed a r and omized clinical trial with surgical patients to evaluate whether plants in hospital rooms have therapeutic influences . METHODS Ninety ( 90 ) patients recovering from a hemorrhoidectomy were r and omly assigned to either control or plant rooms . With half the patients , live plants were placed in their rooms during postoperative recovery periods . Data collected for each patient included length of hospitalization , analgesics used for postoperative pain control , vital signs , ratings of pain intensity , pain distress , anxiety and fatigue , the State-Trait Anxiety Inventory Form Y-1 , the Environmental Assessment Scale , and the Patient 's Room Satisfaction Question naire . RESULTS Viewing plants during the recovery period had a positive influence linking directly to health outcomes of surgical patients . Patients in hospital rooms with plants and flowers had significantly more positive physiologic responses evidence d by lower systolic blood pressure , and lower ratings of pain , anxiety , and fatigue than patients in the control room . Patients with plants also felt more positively about their rooms and evaluated them with higher satisfaction when compared with patients in similar rooms without plants . Based on patients ' comments , plants brightened up the room environment , reduced stress , and also conveyed positive impressions of hospital employees caring for patients . CONCLUSIONS Findings of this study confirmed the therapeutic value of plants in the hospital environment as a noninvasive , inexpensive , and effective complementary medicine for surgical patients . Health care professionals and hospital administrators need to consider the use of plants and flowers to enhance healing environments for patients Objective : This article aim ed to develop the “ forest therapy ” program , which is a cognitive behavior therapy (CBT)-based intervention program using forest environment , and investigate its effects on blood pressure ( BP ) , salivary cortisol , and quality of life ( QoL ) measures in patients with hypertension . Methods : A total of 56 men and women were enrolled for this study , being referred from local health centers in Republic of Korea , from April to October 2009 . They were conveniently assigned to either “ forest ” group participating in the forest therapy program or control group doing self-monitoring of BP . Measurements of salivary cortisol level and QoL were done at initial visits and at 8-week final visits . Results : Both groups did not differ significantly in baseline clinical characteristics . The BP change at week 4 and week 8 did not differ between the two groups . Salivary cortisol level reduction was significantly larger and QoL measures improved significantly more in the forest group at week 8 compared with the control group . Conclusions : The forest therapy program did not induce prolonged systolic blood pressure ( SBP ) reduction . However , considering the significant decrease in cortisol level and improvement in QoL measures , this may be a useful model of community hypertension management program |
1,367 | 19,176,472 | Virtually all analyses yielded results that , on first impression , favored taxonic over dimensional interpretations of the latent structure of schizophrenia .
We conclude that there is no reason to seriously doubt a single-distribution model of schizophrenia because there is no evidence that provides a serious test of this null hypothesis . | This review examines whether there is evidence that the criterion symptoms of Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) ( DSM-IV ) schizophrenia are taxonic -- that schizophrenia is not part of a single distribution of normality .
Two taxometric methods , coherent cut kinetics ( CCK ) and latent variable modeling ( LVM ) , are demonstrated to be sensitive to latent classes and , therefore , were regarded as providing relevant statistical evidence . | Prior research has suggested that the latent structure of the schizotypy construct ( P. E. Meehl , 1990 ) may be qualitative in nature and have a low base rate ( L. Korfine & M. F. Lenzenweger , 1995 ; M. F. Lenzenweger & L. Korfine , 1992 ) . These studies relied on the application of maximum covariance analysis ( MAXCOV ) to 8 true-false format items from a schizotypy measure . The current study sought to examine the robustness of those prior findings through MAXCOV analysis of fully quantitative measures of schizotypy . Measures of perceptual aberration , magical ideation , and referential thinking were analyzed using MAXCOV in a sample of 429 persons . The results of these analyses strongly support a latent taxonic structure for schizotypy and a low base rate for the schizotypy taxon . Furthermore , the members of the putative taxon reveal an increased level of deviance on a psychometric measure known to be associated with schizophrenia liability . The possibility that the dichotomous item format of those items analyzed previously with MAXCOV lead to spurious pseudotaxonicity is greatly diminished in light of these results Classical descriptions of mania subtypes extend back to Kraepelin ; however , in marked contrast to the study of depression subtypes , validation of mania subtypes by multivariate statistical methods has seldom been attempted . We applied Grade of Membership ( GOM ) analysis to the rated clinical features of 327 in patients with DSM-III-R mania diagnoses . GOM is a type of latent structure multivariate analysis , which differs from others of this type in making no a priori distributional assumptions about groupings . We obtained 5 GOM Pure Types with good face validity . The major Kraepelinian forms of “ hypomania , ” “ acute mania , ” “ delusional mania , ” and “ depressive or anxious mania ” were vali date d. The major new finding is of two mixed mania presentations , each with marked lability of mood . The first of these displayed a dominant mood of severe depression with labile periods of pressured , irritable hostility and paranoia , and the complete absence of euphoria or humor . The second mixed mania Pure Type displayed a true , incongruous mixture of affects : periods of classical manic symptoms with euphoria , elation , humor , gr and iosity , psychosis , and psychomotor activation , switching frequently to moderately depressed mood with pressured anxiety and irritability . This multivariate analysis vali date d classical clinical descriptions of the major subtypes of mania . Two distinct forms of mixed manic episodes were identified . DSM-III-R criteria did not reliably identify either of these two natural groups of mixed bipolar patients . As occurs in depression , this clinical heterogeneity of mania may influence response to drug treatments Objective : To describe patients included in the European Mania in Bipolar Longitudinal Evaluation of Medication ( EMBLEM ) study and to assess and clinical ly vali date the presence of clinical subtypes of patients with acute mania P.E. Meehl 's model ( 1962 , 1990 ) of schizotypy and the development of schizophrenia implies that the structure of liability for schizophrenia is dichotomous , hypothesizing that a " schizogene " determines one 's membership in a latent class ( or taxon ; P.E. Meehl & R. R. Golden , 1982 ) . The present study sought to replicate earlier findings concerning the taxonic latent structure and general population base rate of schizotypy ( M. F. Lenzenweger & L. Korfine , 1992 ) . P.E. Meehl 's ( 1973 ; P.E. Meehl & R. R. Golden , 1982 ) MAXCOV-HITMAX taxometric analytic procedures were applied to a subset of items from the Perceptual Aberration Scale ( PAS ; L. J. Chapman , J. P. Chapman , & M. L. Raulin , 1978 ) , a prominent psychometric index of schizotypy , derived from a new r and omly ascertained non clinical university sample ( N = 1,646 ) . Consistent with the authors ' previous results as well as Meehl 's conjectures , the data strongly suggest that schizotypy , as assessed by the PAS , is taxonic at the latent level with a low general population taxon base rate ( i.e. , < .10 ) . Moreover , individuals falling within the putative schizo-taxon underlying the PAS present greater levels of schizotypic phenomenology than nontaxon members . The taxometric analysis of the psychological trait of femininity also reveals that the MAXCOV-HITMAX procedure can detect a latent dimension , when one is hypothesized to exist , and the procedure does not appear to generate " spurious " evidence for taxonicity as a function of the psychometric format ( e.g. , true-false ) of the data under analysis . The statistical implication of a taxonic entity occurring at a low base is discussed with respect to results obtained using the MAXCOV-HITMAX technique BACKGROUND Several studies have found an association between duration of untreated psychosis ( DUP ) and clinical outcomes . However , there is inconsistency concerning the association between outcome on negative symptoms and DUP with some studies having found a correlation between DUP and negative symptoms , while other studies did not find such an association . OBJECTIVE The aim of the present study was to investigate the role of heterogeneity associated with the relationship between DUP and negative symptoms in a sample of first episode psychosis ( FEP ) patients from a multicentre treatment study and a replication sample of subjects from a specialized service in a different jurisdiction . METHOD FEP patients ( n=116 ) treated in specialized programs in two medium sized and one large urban centre were evaluated . Latent class regression was employed to simultaneously classify respondents and estimate the effect of DUP on negative symptoms after one year . The process was repeated on 59 consecutive FEP patients in a specialized service in Montreal . RESULTS The final model reflected three distinct sub-groups with different associations between DUP and negative symptoms : ( a ) for one fourth of the subjects there was a positive association between DUP and negative symptoms , indicating that long DUP was associated with poor negative symptoms outcome ; ( b ) an opposite effect was observed for another sub-group of patients : patients with short DUP scored high on the negative symptoms scale and patients with long DUP reported only a few negative symptoms ; ( c ) there was no association between DUP and negative symptoms outcome for nearly half of the patients . These models were replicated in the Montreal sample . CONCLUSIONS The association between DUP and negative symptoms outcome might differ among sub-groups of first episode patients . Latent class regression analysis offers a flexible way to include unmeasured heterogeneity in outcome analyses Taxometric procedures such as mean above minus below a cut and maximum covariance can determine whether a trait is distributed as a discrete latent class . These methods have been used to infer taxonic structure in several personality and psychopathology constructs , often from analyses of rating scale data . This is problematic given ( a ) well established biases in ratings , ( b ) the human tendency to think categorically , and ( c ) implicit typological models of personality and psychopathology among expert raters . Using an experimental method in which the cognitive sets of raters were manipulated as dimensional versus categorical , it is demonstrated that pseudotaxonicity can be created readily with rating scale measures . This suggests that research ers avoid an exclusive reliance on rating scales when conducting taxometrics investigations |
1,368 | 11,677,710 | There were no data concerning long-term clinical benefits or cost-effectiveness .
In conclusion , self-help treatments may have the potential to improve the overall cost-effectiveness of mental health service provision . | Anxiety and depression are prevalent in primary care ; however , current treatments differ in their availability , cost-effectiveness , and acceptability to patients .
Self-help treatments ( such as manual-based bibliotherapy ) may be an appropriate intervention for some patients . | We performed a r and omized controlled study to evaluate computer-based cognitive behavioral therapy in 36 patients who met Research Diagnostic Criteria for major or minor depression . Patients were r and omly assigned to the computer , to a therapist , or to a control group placed on a waiting list . As determined by three measures of depression ( the Beck inventory , the Hamilton rating scale , and the Symptom Checklist-90-R ) , both treated groups had improved significantly more than the control group at the end of the treatment period and 2 months later . The treated groups did not differ from each other at either time BACKGROUND Counselling in primary care setting s remains largely unevaluated . Such evaluation has been strongly recommended . AIM To determine the relative effectiveness and cost-effectiveness of generic counselling and usual general practitioner ( GP ) care for patients with minor mental health problems . METHOD A r and omized controlled trial and health economic evaluation were carried out in nine general practice s. Access to generic counselling ( brief counselling , generally involving up to six 50-minute sessions ) was compared with usual GP care . A total of 162 patients aged 16 years and over with diverse mental health problems ( excluding phobic conditions and psychoses ) were r and omized . The Hospital Anxiety and Depression ( HAD ) scale , COOP/WONCA ( World Organization of Family Doctors ) functional health assessment charts , and the delighted-terrible faces scale were used to assess outcome four months after r and omization . RESULTS The two groups were similar at baseline . There were significant improvements in both groups between r and omization and follow-up for most outcome measures , but no significant differences between the study arms . The 95 % confidence limits were narrow and excluded clinical ly significant effects . Under various assumptions concerning the cost of secondary care referrals and of counselling time , no clear cost advantage was associated with either intervention . CONCLUSIONS This pragmatic trial demonstrates no difference in functional or mental health outcome at four months between subjects offered access to counselling and those given usual care by their GP . There is no clear difference in the cost-effectiveness of the two interventions . Purchasers should take account of these findings in allocating re sources within primary care Abstract Objective : To compare the clinical effectiveness of general practitioner care and two general practice based psychological therapies for depressed patients . Design : Prospect i ve , controlled trial with r and omised and patient preference allocation arms . Setting : General practice s in London and greater Manchester . Participants : 464 of 627 patients presenting with depression or mixed anxiety and depression were suitable for inclusion . Interventions : Usual general practitioner care or up to 12 sessions of non-directive counselling or cognitive-behaviour therapy provided by therapists . Main outcome measures : Beck depression inventory scores , other psychiatric symptoms , social functioning , and satisfaction with treatment measured at baseline and at 4 and 12 months . Results : 197 patients were r and omly assigned to treatment , 137 chose their treatment , and 130 were r and omised only between the two psychological therapies . All groups improved significantly over time . At four months , patients r and omised to non-directive counselling or cognitive-behaviour therapy improved more in terms of the Beck depression inventory ( mean ( SD ) scores 12.9 ( 9.3 ) and 14.3 ( 10.8 ) respectively ) than those r and omised to usual general practitioner care ( 18.3 ( 12.4 ) ) . However , there was no significant difference between the two therapies . There were no significant differences between the three treatment groups at 12 months ( Beck depression scores 11.8 ( 9.6 ) , 11.4 ( 10.8 ) , and 12.1 ( 10.3 ) for non-directive counselling , cognitive-behaviour therapy , and general practitioner care ) . Conclusions : Psychological therapy was a more effective treatment for depression than usual general practitioner care in the short term , but after one year there was no difference in outcome The aim of this study was to evaluate the effectiveness of 2 methods of administering a cognitive-behavioral self-help program for binge eating disorder . The study was design ed to reproduce many of the conditions that apply in setting s in which self-help interventions are most relevant . Seventy-two women with binge eating disorder were r and omly assigned to 1 of 3 conditions for 12 weeks : pure self-help ( PSH ) , guided self-help ( GSH ) , or a waiting list ( WL ) control condition ( followed by PSH or GSH ) . They were then followed up for 6 months . Both PSH and GSH had a substantial and sustained impact with almost half the participants ceasing to binge eat . There was little change in the WL condition . Cognitive-behavioral self-help may be of value both as an initial treatment for binge eating disorder and as a form of secondary prevention Behavioural methods of treating anxiety have been shown to be highly effective but are not widely available in general practice where most people suffering from anxiety are treated . This study reports a development in service delivery which is simple , inexpensive and does not make great time dem and s on general practitioners or require them to extend their training and expertise . The study shows that for patients suffering from panic disorder or generalized anxiety disorder the use of an anxiety management booklet in addition to their usual treatment from their general practitioner produces clinical ly and statistically significant improvements . Of particular importance is the speed of response to the booklet . Within the first two weeks those patients who received the booklet were significantly less anxious than the controls . The booklet was acceptable to patients and recommendations are made about how to incorporate it into clinical practice The efficacy of a self-help package in treating chronic anxiety was evaluated in a r and omized controlled trial in which the intervention group received self-help material s in the form of an audiotape and booklet , in addition to their current treatment . The intervention was successful in terms of mean depression scores ( P = 0.01 ) , anxiety scores ( P = 0.04 ) and general health question naire scores ( P = 0.02 ) which were significantly lower for the intervention group than for the controls . In addition , the depression scores fell faster for the intervention group than for the controls . The overall mean reduction in three months in adjusted depression scores was approximately two points greater for the intervention group than for the controls ( P = 0.02 ) . Clinicians welcomed the package as a valuable addition to the therapies available for managing chronic anxiety problems . Further studies should include larger sample sizes , taking into account the non-response to postal question naires over time The efficacy of cognitive bibliotherapy for adolescents experiencing mild and moderate depressive symptomatology was examined with a group of 22 community-dwelling adolescents . Cognitive bibliotherapy was determined to be superior to a delayed-treatment control condition . The treatment produced both statistically and clinical ly significant improvements in depressive symptoms . Treatment gains were maintained at 1-month follow-up . A significant decrease in dysfunctional thoughts , but not in negative automatic thoughts , was found after treatment . These results contribute to converging evidence on the efficacy of cognitive-behavioral treatments for adolescents experiencing depressive symptoms A controlled trial study which examined the clinical effectiveness of a stress self-help package administered by general practitioners to patients presenting with psychological problems which were potentially stress-related is described . Patients were r and omly allocated to one of two groups : existing general practitioner treatment with or without the use of the package . Significant advantages were found for patients who received the package compared with controls in both their level of symptoms at three-month follow-up and their rate of consulting for psychological problems in the three-month post-treatment period compared with the three-month pre-treatment period . The potential use of such packages in the treatment of psychological problems in primary care is discussed OBJECTIVE This study assessed relationships among psychological symptoms , past and current psychiatric disorder , functional impairment , somatic symptoms , chronic fatigue , and chronic fatigue syndrome . METHOD A prospect i ve cohort study was followed by a nested case-control study . The subjects , aged 18 - 45 years , had been in primary care for either clinical viral infections or a range of other problems . Question naire measures of fatigue and psychological symptoms were completed by 1,985 subjects 6 months later ; 214 subjects with chronic fatigue were then compared with 214 matched subjects without fatigue . Assessment s were made with question naires , interviews , and medical records of fatigue , somatic symptoms , psychiatric disorder , and functional impairment . RESULTS Subjects with chronic fatigue were at greater risk than those without chronic fatigue for current psychiatric disorder assessed by st and ardized interview ( 60 % versus 19 % ) or by question naire ( 71 % versus 31 % ) . Chronic fatigue subjects were more likely to have received psychotropic medication or experienced psychiatric disorder in the past . There was a trend for previous psychiatric disorder to be associated with comorbid rather than noncomorbid chronic fatigue . Most subjects with chronic fatigue syndrome also had current psychiatric disorder when assessed by interview ( 75 % ) or question naire ( 78 % ) . Both the prevalence and incidence of chronic fatigue syndrome were associated with measures of previous psychiatric disorder . The number of symptoms suggested as characteristics of chronic fatigue syndrome was closely related to the total number of somatic symptoms and to measures of psychiatric disorder . Only postexertion malaise , muscle weakness , and myalgia were significantly more likely to be observed in chronic fatigue syndrome than in chronic fatigue . CONCLUSIONS Most subjects with chronic fatigue or chronic fatigue syndrome in primary care also meet criteria for a current psychiatric disorder . Both chronic fatigue and chronic fatigue syndrome are associated with previous psychiatric disorder , partly explained by high rates of current psychiatric disorder . The symptoms thought to represent a specific process in chronic fatigue syndrome may be related to the joint experience of somatic and psychological distress |
1,369 | 12,917,703 | There was a suggestion that spouse involvement increased effectiveness but that adolescents achieved greater weight loss when treated alone .
In studies including children , beneficial effects were seen when greater numbers of behaviour change techniques were taught to both parents and children .
: Relatively few intervention studies exist in this important area , particularly studies targeting adolescents , and they highlight continued uncertainty about how best to involve family members .
The studies provide limited support for the involvement of spouses .
They suggest that parental involvement is associated with weight loss in children , and that use of a greater range of behaviour change techniques improves weight outcomes for both parents and children . | OBJECTIVE : To conduct a descriptive systematic review into the nature and effectiveness of family involvement in weight control , weight maintenance and weight-loss interventions . | Obese children ( 8 - 13 years old ) and at least one of their parents participated in a behaviorally oriented treatment program . Participants in a st and ard treatment condition experienced a multicomponent intervention in which parents were given primary responsibility for following program prescriptions . An enhanced child involvement condition provided the same basic intervention but with greater emphasis on , and training in , child self-regulation . Children in both conditions achieved a significant reduction in percentage overweight and triceps skin-fold during the 6-month treatment period . Overall , the follow-up period of 3 years was characterized by increases above posttreatment levels . There was , however , some suggestion in the 3-year follow-up results and the long-term patterns over a 6 1/2-year period of the benefits of the enhanced child involvement approach . Findings are discussed in terms of suggestions for reconsideration of treatment goals , improved interventions , and refinements in the assessment of self-regulatory behavior Weight and blood pressure changes were evaluated in a 16-month controlled trial comparing three methods of involving mothers in the treatment of their obese adolescents ( aged 12 to 16 years ) . The treatments were : ( 1 ) Mother-Child Separately -- children and mothers attended separate groups ; ( 2 ) Mother-Child Together -- the children and mothers met together in the same group ; and ( 3 ) Child Alone -- the children met in groups and mothers were not involved . The program consisted of behavior modification , social support , nutrition , and exercise . The Mother-Child Separately group lost more weight ( 8.4 kg ) during treatment than did the other two groups ( 5.3 and 3.3 kg ) . Differences between the groups increased at the 1-year follow-up : compared to pretreatment weight , the Mother-Child Separately group lost 7.7 kg compared with gains of approximately 3 kg in the other two groups . Blood pressures of children with the highest initial pressures decreased by 16/9 mm Hg at the end of treatment and by 16/5 mm Hg at the 1-year follow-up . These results suggest that a program of behavior modification and parent involvement can lead to significant weight losses in obese children , and that the nature of parent involvement may be important Two types of goal - setting ( daily vs weekly ) and two levels of spouse involvement ( couples vs individual treatment ) were evaluated in a 19-week behavioral weight-control program . Forty-seven married Ss with spouses willing to participate were r and omly assigned to one of four treatments : Couples/Weekly Goals , Couples/Daily Goals , Individual/Weekly Goals , Individual/Daily Goals . At posttreatment , Ss had lost an average of 171b and reduced their percent over ideal weight from 49 to 36 % . Losses were maintained at the 6-month clinic follow-up . Weight losses for the two goal - setting conditions and the two spouse treatments did not differ . Improvements were observed in resting pulse , blood pressure and step-test time , and these were maintained at the 6-month follow-up . Adherence to caloric self-monitoring , self-reported exercise adherence and marital satisfaction were significantly correlated with weight loss . Decreases in depression and improvements in body-image satisfaction were also observed . Mail and telephone follow-up at 12 and 30 months posttreatment indicated satisfactory maintenance for the majority of Ss . Factors associated with maintenance and relapse during long-term follow up are discussed STUDY OBJECTIVE To evaluate the effect of family therapy on childhood obesity . DESIGN Clinical trial . One year follow-up . SETTING Referral from school after screening . PARTICIPANTS Of 1774 children ( aged 10 to 11 ) , screened for obesity , 44 obese children were divided into two treatment groups . In an untreated control group of 50 obese children , screened in the same manner , body mass index ( BMI ) values were recorded twice , at 10 to 11 and at 14 years of age . INTERVENTION Both treatment groups received comparable dietary counseling and medical checkups for a period of 14 to 18 months , while one of the groups also received family therapy . RESULTS At the 1-year follow-up , when the children were 14 years of age , intention-to-treat analyses were made of the weight and height data for 39 of 44 children in the two treatment groups and for 48 of the 50 control children . The increase of BMI in the family therapy group was less than in the conventional treatment group at the end of treatment , and less than in the control group ( P = .04 and P = .02 , respectively ) . Moreover , mean BMI was significantly lower in the family therapy group than in the control group ( P < .05 ) , and the family therapy group also had fewer children with BMI > 30 than the control group ( P = .02 ) . The reduction of triceps , subscapular , and suprailiac skinfold thicknesses , expressed as percentages of the initial values , was significantly greater in the family therapy group than in the conventional treatment group ( P = .03 , P = .005 and P = .002 , respectively ) , and their physical fitness was significantly better ( P < .05 ) . CONCLUSIONS Family therapy seems to be effective in preventing progression to severe obesity during adolescence if the treatment starts at 10 to 11 years of age Abstract The present study was conducted to determine if husb and attendance at treatment sessions and participation in behavioral contracting would produce greater weight losses than two other levels of spouse involvement . The three treatment groups investigated did not significantly differ at post-treatment but by 1-yr follow-up female S s who attended treatment sessions alone and contracted with the counselor ( HA ) lost significantly more weight than women who attended sessions with their husb and s and also contracted with the counselor ( HNC ) . The S s who attended sessions with their husb and s and contracted with them ( HC ) did not significantly differ from S s in the other two conditions . The total amount lost by S s in the HA , HNC and HC conditions by 1-yr follow-up was 16.4 , 4.4 and 15.5 lb , respectively . The study was also conducted to collect preliminary data about procedures S s used during long-term follow-up to ascertain if weight losses during follow-up could be attributed to the behavioral weight-loss techniques learned during the treatment program . At all follow-up periods , many S s reported using behavioral weight-loss techniques but 4 of the 36 S s ( 11.1 % ) at 1-yr follow-up , 15 of the 23 ( 65.2 % ) and 24 of the 25 ( 96.0 % ) who responded , respectively , at 3- and 4-yr follow-up had used other weight-loss programs or methods . A possible confound for follow-up data was identified and suggestions for future research were presented OBJECTIVE To compare the effectiveness of behavioral family systems therapy ( BFST ) with that of ego-oriented individual therapy ( EOIT ) as treatments for adolescents with anorexia nervosa . METHOD Thirty-seven adolescents meeting DSM-III-R criteria for anorexia nervosa were r and omly assigned to receive BFST or EOIT , in addition to a common medical and dietary regimen . In BFST , the family was seen conjointly , the parents were placed in control of the adolescent 's eating , distorted beliefs were targeted through cognitive restructuring , and strategic/behavioral interventions were used to change family interactions . In EOIT , the adolescent was seen individually , with an emphasis on building ego strength and uncovering the dynamics blocking eating ; parents were seen collaterally . Measures administered before , after , and at 1-year follow-up tapped body mass index , menstruation , eating attitudes , ego functioning , depression , and family interactions . RESULTS BFST produced greater weight gain and higher rates of resumption of menstruation than EOIT . Both treatments produced comparably large improvements in eating attitudes , depression , and eating-related family conflict , but very few changes occurred on ego functioning . CONCLUSIONS BFST and EOIT proved to be effective treatments for adolescents with anorexia nervosa , but BFST produced a faster return to health Using a prospect i ve , r and omized , controlled design , we examined the effects of behavioral family-based treatment on percent overweight and growth over 10 years in obese 6- to 12-year-old children . Obese children and their parents were r and omized to three groups that were provided similar diet , exercise , and behavior management training but differed in the reinforcement for weight loss and behavior change . The child and parent group reinforced parent and child behavior change and weight loss , the child group reinforced child behavior change and weight loss , and the nonspecific control group reinforced families for attendance . Children in the child and parent group showed significantly greater decreases in percent overweight after 5 and 10 years ( -11.2 % and -7.5 % , respectively ) than children in the nonspecific control group ( + 7.9 % and + 14.3 % , respectively ) . Children in the child group showed increases in percent overweight after 5 and 10 years ( + 2.7 % and + 4.5 % , respectively ) that were midway between those for the child and parent and nonspecific groups and not significantly different from either . At 10 years , child height was related strongly to the height of the parent of the same sex ( r = .78 children were 1.8 cm taller than their parents , with no differences in height between groups This study tested the effects of mastery criteria and contingent reinforcement in a family-based behavioral weight control program for obese children and their parents over two years . Families with obese children were r and omized to one of two groups . The experimental group was targeted and reinforced for mastery of diet , exercise , weight loss , and parenting skills . The control group was taught behavior-change strategies and provided noncontingent reinforcement at a pace yoked to the experimental group . Both groups received the same behavioral family-based educational components over 6 months of weekly meetings and six monthly follow-up meetings . Results showed significantly better relative weight change at 6 months and 1 year for children in the experimental compared to the control group , but these effects were not maintained at 2 years . These results suggest the introduction of mastery criteria and contingent reinforcement for mastery can improve outcome during treatment in behavioral treatments for childhood obesity Forty-nine obese diabetic patients with obese spouses ( diabetic or nondiabetic ) were r and omly assigned to an alone or together condition . Patients in the alone group participated by themselves in a 20-week behavioral weight control program ; their spouses attended assessment sessions only . Patients in the together group attended the program with their spouses ; both were targeted for weight loss and taught social support strategies . Weight losses of patients treated alone and together did not differ significantly at posttreatment ( 19.9 vs. 19.1 lb ) or 1-year follow-up ( 11.6 vs. 7.0 lb ) . However , there was a significant interaction of treatment and gender ; women did better when treated with their spouses , whereas men did better when treated alone . A " family-based " approach was not effective for these obese Type II diabetic patients as a whole but may be helpful for women This study investigated whether husb and participation would augment the effectieness of the Sturart & Davis ( 1972 ) weight-reduction program for 37 obese women . Following a five-week baseline period , participants were taught behavioral weight-control techniques in eight 90-minute sessions over a 16-week period . R and om assignment was made to conditions that required husb and s to participate in all treatment sessions , the first four sessions , or not at all . Results indicated that although women in all three conditions lost significant amounts of weight and developed more adaptive eating habits , husb and involvement fostered reliably greater weight loss , which was maintained through a six-week post-treatment assessment . Participant husb and s became more accurate observers of changes in their wives ' eating habits and were viewed as being more helpful than were noninvolved husb and s. A three-year follow-up indicated that the wives had maintained their initial weight losses and reported changes in eating habits , while the effects engendered by husb and involvement had dissipated Two groups of cerebral palsied , mentally retarded , overweight adults received training in seven behavioral self-control techniques for reducing caloric intake and increasing activity levels over the course of 19 weeks . One group 's parents/caretakers had frequent contacts from the diet leader , ( Home-Help Group ) ; the other group , balanced with the first for degree of h and icap , had no caretaker-directed communications other than initial notification ( No Help Group ) . Measures of adherence were included to assess the process of behavioral change during the diet program . A significant treatment effect accrued for all participants in the diet program , with the Home-Help Group of dieters showing clinical ly , though not statistically superior weight loss at treatment end and at follow-ups through one year . Specific behaviors taught , such as replacing utensils after each bite and eating slowly , showed significant changes in the expected directions with weight change . Implication s of the data for future treatment programs are discussed |
1,370 | 21,785,341 | There was no difference in blood loss .
Analysis of 5-year survival showed no significant difference between the groups and was subject to significant heterogeneity .
This meta- analysis of studies comparing transthoracic with transhiatal esophagectomy for cancer demonstrates no difference in 5-year survival , however lymphadenectomy and reported surgical quality was suboptimal in both groups and the transthoracic group had significantly more advanced cancer . | OBJECTIVE To study the differences in short and long-term outcomes of transthoracic and transhiatal esophagectomy for cancer .
BACKGROUND Studies have compared transthoracic with transhiatal esophagectomy with varying results .
Previous systematic review s ( 1999 , 2001 ) do not include the latest r and omized controlled trials . | Objective To identify factors that have contributed to reduced rates of death and complications after esophageal resection in a 17-year period at a tertiary referral center . Summary Background Data There has been an evolving refinement in surgical technique and perioperative management of patients undergoing esophageal resection at Queen Mary Hospital during the past two decades . As of the end of 1998 , there had been no hospital deaths among the last 105 consecutive resections performed for esophageal squamous cancer . Methods The results of esophageal resection for squamous cell carcinoma were analyzed using a prospect i ve esophageal data base . A longitudinal study was performed to compare and analyze rates of death and complications for three consecutive time periods . Results The study group comprised 710 patients who underwent one-stage esophageal resection between 1982 and 1998 . A transthoracic esophagectomy was the preferred approach in 590 patients ( 83 % ) . The overall hospital death rate was 11 % . The leading causes of hospital death were pulmonary complications ( 45.5 % ) and progression of malignant disease ( 21.5 % ) ; anastomotic leakage accounted for 9 % of deaths . During the study period , the hospital death rate decreased from 16 % to 3.2 % , and the incidence of postoperative respiratory failure decreased from 15.5 % to 6.5 % . Perioperative factors that correlated with the decreased death rate over time were the increased postoperative use of epidural analgesia and bronchoscopy ( for clearance of pulmonary secretions ) , a decrease in history of smoking , and a decrease in surgical blood loss of more than 1,000 mL. Conclusions In this series of predominantly transthoracic esophagectomies , there has been a decline in the hospital death rate to less than 5 % . These results are largely attributable to factors aim ed at reducing postoperative pulmonary complications Background We clarified the incidence of adenocarcinoma of the esophagogastric junction ( AEG ) at a Japanese high-volume cancer center and its clinicopathological features between the Siewert subtypes . Methods Patients with AEG were selected from a prospect i ve data base of gastric and esophageal tumors established by Kanagawa Cancer Center . The Siewert subtypes were determined retrospectively by examining pathological pictures of the resected specimens and by evaluating the pathology and endoscopy findings . Results From January 1986 to December 2005 , 147 ( 4.0 % ) patients were determined to have AEG ; 2,794 ( 75.8 % ) were diagnosed to be true gastric cancer , whereas 745 ( 20.2 % ) were true esophageal cancer . Of these 147 patients with AEG , 5 ( 3.4 % ) were classified as type I , 82 ( 55.8 % ) as type II , and 60 ( 40.8 % ) as type III tumors . The depth of tumor invasion was deeper and the nodal metastases were more frequent in type III compared with type II . The risk factors for nodal metastases included the depth and size of the tumor , but not the Siewert subtypes itself . Mediastinal nodal metastases were strongly influenced by a thoracotomy and the extent of the dissection . The pathological grade was higher in type III than in type II . Although the 5-year survival rate was significantly higher in type II than in type III tumors , the survival difference disappeared when the patients were restricted to an R0 resection , even though type III patients demonstrated a more advanced stage . Conclusions The proportions of AEG were strikingly different between Japan and western countries . Although each Siewert subtype had some different characteristics , nodal metastases were determined by both the tumor progression and the extent of the nodal dissection . An R0 resection was a key for the survival in AEG Purpose : To investigate the importance of lymph node yield ( LNY ) and the ratio of afflicted lymph nodes in esophageal carcinoma patients . Patients and Methods : Between 1992 and 2004 , 368 patients with esophageal carcinoma underwent surgery . Esophagectomy with curative intent was performed in 255 patients . Subtotal esophagectomy was performed either by thoracoabdominal ( 104 patients , 40.8 % ) or by transhiatal approach ( 151 patients , 59.2 % ) . Results : According to the LNY , patients were grouped into 3 groups . Twenty-six patients had ≤5 , 96 had 6 to 18 , and 113 had ≥19 dissected lymph nodes . In patients with nodal involvement ( pN1 ) , no significant overall survival differences were identified when stratifying subgroups according to the LNY . However , LNY had striking prognostic relevance in pN0 patients . The median overall survival was 23 ( ≤5 LN ) , 36 ( 6–18 LN ) , and 88 months ( ≥19 ) . Even for patients with tripled LNY than the proposed minimum by the International Union Against Cancer ( UICC ) ( 18 LN ) , the rate of patients with detected lymph node metastases was only 46 % , compared with 61 % for patients with a LNY of ≥19 ( P = 0.002 ) . In pN1 patients classified according to the ratio of afflicted lymph nodes , median overall survival was 27 months in patients with a ratio < 11 % , compared with 15 and 13 months in patients with a ratio of 11 % to 33 % and > 33 % , respectively ( P < 0.001 ) . Multivariate Cox regression modeling identified ratio as the strongest independent prognostic factor for overall survival in pN1 and the LNY in pN0 patients . Conclusions : The minimal regional LNY of 6 lymph nodes as recommended by the UICC for esophageal carcinoma is far too low to appropriately stage the disease . The LNY and the ratio should be reflected in the next version of the UICC classification OBJECTIVE To study survival , morbidity , and ability to swallow , after oesophagectomy for cancer of the oesophagus and cardia . DESIGN Prospect i ve open study . SETTING University hospital , Norway . SUBJECTS 83 patients , 38 with squamous cell carcinoma and 45 with adenocarcinoma of the oesophagus and cardia . INTERVENTIONS Transhiatal ( n = 51 ) and transthoracic ( n = 32 ) oesophagectomy . Oesophageal replacement was by either stomach ( n = 80 ) or colon ( n = 3 ) . Cervical anastomosis was used in all but 2 . MAIN OUTCOME MEASURES Early and late morbidity and mortality , length of stay in intensive care unit and in hospital , and survival analysis . RESULTS 30 Day and in hospital mortality were 0 and 4 % for transhiatal , and 6 % and 9 % for transthoracic , oesophagectomy . Complications included recurrent nerve palsy ( n = 7 ) , anastomotic leaks ( n = 5 ) , and chylothorax ( n = 4 ) . 17 Patients ( 22 % ) needed dilatations for stenosis of the anastomosis , and 71 ( 85 % ) of the patients left hospital within four weeks of operation . Survival analysis showed a 5 year survival rate of 33 % for patients with adenocarcinoma operated on for cure and a 2 year survival of 28 % for patients with squamous cell carcinoma . CONCLUSIONS Oesophagectomy for cure is worthwhile as some patients are cured and most of the remainder have prolonged relief of their dysphagia . Palliative resections should not be done in patients with distant metastases or invasion of adjacent organs by the tumour because of long stay in hospital , appreciable morbidity , and short life expectancy Objective : “ Rediscovered ” in 1976 , transhiatal esophagectomy ( THE ) has been applicable in most situations requiring esophageal resection and reconstruction . The objective of this study was to review the authors ’ 30-year experience with THE and changing trends in its use . Methods : Using the authors ’ prospect i ve Esophagectomy Data base , this single institution experience with THE was analyzed retrospectively . Results : Two thous and and seven THEs were performed—1063 ( previously reported ) between 1976 and 1998 ( group I ) and 944 from 1998 to 2006 ( group II ) , 24 % for benign disease , 76 % , cancer . THE was possible in 98 % . Stomach was the esophageal substitute in 97 % . Comparing outcomes between group I and group II , statistically significant differences ( P < 0.001 ) were observed in hospital mortality ( 4 % vs. 1 % ) ; adenocarcinoma histology ( 69 % vs. 86 % ) ; use of neoadjuvant chemoradiation ( 28 % vs. 52 % ) ; mean blood loss ( 677 vs. 368 mL ) ; anastomotic leak ( 14 % vs. 9 % ) ; and discharge within 10 days ( 52 % vs. 78 % ) . Major complications remain infrequent : wound infection/dehiscence , 3 % , atelectasis/pneumonia , 2 % , intrathoracic hemorrhage , recurrent laryngeal nerve paralysis , chylothorax , and tracheal laceration , < 1 % each . Late functional results have been good or excellent in 73 % . Aggressive preoperative conditioning , avoiding the ICU , improved pain management , and early ambulation reduce length of stay , with 50 % in group II discharged within 1 week . Conclusion : THE refinements have reduced the historic morbidity and mortality of esophageal resection . This largest reported THE experience reinforces the value of consistent technique and a clinical pathway in managing these high acuity esophageal patients Objective : Using Worldwide Esophageal Cancer Collaboration data , we sought to ( 1 ) characterize the relationship between survival and extent of lymphadenectomy , and ( 2 ) from this , define optimum lymphadenectomy . Summary Background Data : What constitutes optimum lymphadenectomy to maximize survival is controversial because of variable goals , analytic methodology , and generalizability of the underpinning data . Methods : A total of 4627 patients who had esophagectomy alone for esophageal cancer were identified from the Worldwide Esophageal Cancer Collaboration data base . Patient-specific risk-adjusted survival was estimated using r and om survival forests . Risk-adjusted 5-year survival was averaged for each number of lymph nodes resected and its relation to cancer characteristics explored . Optimum number of nodes that should be resected to maximize 5-year survival was determined by r and om forest multivariable regression . Results : For pN0M0 moderately and poorly differentiated cancers , and all node-positive ( pN+ ) cancers , 5-year survival improved with increasing extent of lymphadenectomy . In pN0M0 cancers , no optimum lymphadenectomy was defined for pTis ; optimum lymphadenectomy was 10 to 12 nodes for pT1 , 15 to 22 for pT2 , and 31 to 42 for pT3/T4 , depending on histopathologic cell type . In pN+M0 cancers and 1 to 6 nodes positive , optimum lymphadenectomy was 10 for pT1 , 15 for pT2 , and 29 to 50 for pT3/T4 . Conclusions : Greater extent of lymphadenectomy was associated with increased survival for all patients with esophageal cancer except at the extremes ( TisN0M0 and ≥7 regional lymph nodes positive for cancer ) and well-differentiated pN0M0 cancer . Maximum 5-year survival is modulated by T classification : resecting 10 nodes for pT1 , 20 for pT2 , and ≥30 for pT3/T4 is recommended CONTEXT Hospitals that treat a relatively high volume of patients for selected surgical oncology procedures report lower surgical in-hospital mortality rates than hospitals with a low volume of the procedures , but the reports do not take into account length of stay or adjust for case mix . OBJECTIVE To determine whether hospital volume was inversely associated with 30-day operative mortality , after adjusting for case mix . DESIGN AND SETTING Retrospective cohort study using the Surveillance , Epidemiology , and End Results (SEER)-Medicare linked data base in which the hypothesis was prospect ively specified . Surgeons determined in advance the surgical oncology procedures for which the experience of treating a larger volume of patients was most likely to lead to the knowledge or technical expertise that might offset surgical fatalities . PATIENTS All 5013 patients in the SEER registry aged 65 years or older at cancer diagnosis who underwent pancreatectomy , esophagectomy , pneumonectomy , liver resection , or pelvic exenteration , using incident cancers of the pancreas , esophagus , lung , colon , and rectum , and various genitourinary cancers diagnosed between 1984 and 1993 . MAIN OUTCOME MEASURE Thirty-day mortality in relation to procedure volume , adjusted for comorbidity , patient age , and cancer stage . RESULTS Higher volume was linked with lower mortality for pancreatectomy ( P=.004 ) , esophagectomy ( P<.001 ) , liver resection ( P=.04 ) , and pelvic exenteration ( P=.04 ) , but not for pneumonectomy ( P=.32 ) . The most striking results were for esophagectomy , for which the operative mortality rose to 17.3 % in low-volume hospitals , compared with 3.4 % in high-volume hospitals , and for pancreatectomy , for which the corresponding rates were 12.9 % vs 5.8 % . Adjustments for case mix and other patient factors did not change the finding that low volume was strongly associated with excess mortality . CONCLUSIONS These data support the hypothesis that when complex surgical oncologic procedures are provided by surgical teams in hospitals with specialty expertise , mortality rates are lower Background Despite a considerable number of r and omized studies , the surgical approach to locally advanced adenocarcinoma of the esophagogastric junction ( AEG ) I and II is still discussed controversially . Thus , we evaluated the surgical risk and outcome after an abdominothoracic esophagectomy ( Ivor-Lewis ) with intrathoracic anastomosis as st and ard procedure . Methods Between 1998 and 2006 , a total of 240 consecutive patients underwent st and ardized right thoracoabdominal esophagectomy with two-field lymphadenectomy and intrathoracic anastomosis ( Ivor-Lewis operation ) for AEG I ( n = 206 ) or AEG II ( n = 34 ) . A total of 157 patients ( 65.4 % ) had neoadjuvant chemotherapy . Results Postoperative morbidity occurred in 17.9 % ( 43 of 240 ) . Overall mortality was 3.8 % ( 9 of 240 ) . The majority of patients ( 4 of 9 ) died because of severe pulmonary complications ( 44.4 % ) irrespective of surgical complications . Neoadjuvant chemotherapy did not increase morbidity or mortality . The median overall survival was 51 months . Multivariate analysis including age > 75 years , clinical response to chemotherapy , complications , R-category and N-category revealed R-category ( P = .005 ; relative risk [ RR ] 0.32 , 95 % confidence interval [ 95 % CI ] 0.14–0.70 ) and complications ( P < .001 , RR 0.16 , 95 % CI 0.08–0.35 ) as independent prognostic factors for all patients . Complications was the only independent prognostic factor ( P < .001 , RR 0.09 , 95 % CI 0.08–0.35 ) for the R0 resected patients . Conclusions At an experienced center , Ivor-Lewis resection is a safe surgical procedure . Outcome of patients was significantly influenced by surgical factors such as complete resection and complications . Neoadjuvant chemotherapy did not lead to higher morbidity and mortality . The high mortality from non-surgery – related complications emphasizes the importance of careful preoperative evaluation of comorbidities and patient selection A prospect i ve r and omized trial of 67 patients undergoing oesophagectomy by either a transhiatal approach or right‐sided thoracotomy was conducted over a 40‐month period . In 32 patients the approach was transhiatal and 35 had a thoracotomy ; the groups were well matched before operation . There were two hospital deaths in patients having the transhiatal oesophagectomy and three in those undergoing thoracotomy . Blood transfusion , intensive care stay and overall time of hospitalization were not significantly different between the two groups . There was no difference in the postoperative morbidity rate and , in particular , the incidences of pulmonary complications were similar ( 19 per cent for transhiatal oesophagectomy , 20 per cent for thoracotomy ) with anastomotic fistula in 6 and 9 per cent respectively . The median ( range ) operating time was significantly longer in patients having thoracotomy ( 6 ( 3.5–9.5 ) versus 4 ( 3–8 ) h ) . Long‐term survival was unaffected by the type of operation performed or addition of preoperative chemotherapy or radiotherapy . Nodal status was a signficant prognostic factor within but not between the two groups . It is concluded that oesophagectomy by a transhiatal route or right thoracotomy are equally effective surgical options for treatment of squamous cell oesophageal cancer Among 86 patients who underwent resection for thoracic esophageal carcinoma between 1982 and 1989 , 49 were resected by a transhiatal blunt esophagectomy ( THE ) and 37 underwent a transthoracic-abdominal esophagectomy ( TTE ) . The two groups were statistically comparable with respect to preoperative characteristics . Overall morbidity and respiratory complications were high for both groups ( 71 % vs 62 % and 45 % vs 46 % ; P = NS ) . The rate of cardiac , renal , neurological and bleeding complications , as well as recurrent nerve injuries was similar in both groups . An anastomotic leak occurred in 39 % ( 19/49 ) of THE patients and in 11 % ( 4/37 ) ( P < 0.05 ) of TTE patients . Hospital mortality was 16 % ( 8/49 ) in the THE group ( 4 result ing from cervical anastomotic leaks , 4 from respiratory complications ) and 13 % ( 5/37 ) in the TTE patients ( 1 from myocardial infa rct ion , 4 from respiratory failures ; P = NS ) . Actuarial survival curves for all THE and TTE patients ( 5-year survival rate : 20 % vs 22 % ) and separate analysis for N0 and N1 tumors revealed no significant difference between these two techniques . Of the different preoperative variables , only tobacco addiction , beside lymph node involvement , was an independent predictor of outcome . Respiratory complications and hospital mortality were significantly lower for the non-smokers and long term survival was significantly higher for the N0 stages BACKGROUND / AIMS Transthoracic and transhiatal esophagectomy are two common procedures for esophageal cancer resection . Prospect i ve studies comparing the two methods in Asian people are few . In addition , the data comparing their effects on the quality of life are lacking . METHODOLOGY A prospect i ve r and omized study was conducted from January 2003 . Patients of resectable esophageal cancer of comparable stage were allocated to undergo the transthoracic or transhiatal procedure in turn . They were all reconstructed with stomach interposition through the retrosternal route . Discharged patients were followed-up in the outpatient clinic . They were question ed on the topics of ( i ) severity of pain , ( ii ) ease of swallowing , ( iii ) satisfaction of daily activities , ( iv ) dependence on medications , ( v ) working ability , ( vi ) fatigue , ( vii ) appetite , ( viii ) sociality , ( ix ) happiness and ( x ) self respect , in the third , sixth and twelfth month . Also the demographic data , operative results and survival were recorded . RESULTS Up to December 2006 , eighty-seven patients of stage II and III , including 71 patients of middle third lesions and 16 lower third lesions were enrolled . The operation time was significantly longer , and the leakage rate was higher in the transthoracic group ( Student 's t-test and Fischer 's exact test , respectively ) . However , intraoperative blood loss and postoperative hospital stay were not significantly different ( Student t-test ) . Also , the Kaplan-Meier survival curves of these two groups were not significantly different by log-rank test ( p=0.286 ) . The score on the quality of life of transhiatal patients was significantly higher than that of transthoracic patients in the third , sixth and twelfth month . CONCLUSIONS Transhiatal esophagectomy is a safe and fast procedure . The survival was similar to that of transthoracic approach . Its leakage rate was lower and quality of life was better Objective : To determine whether the length of esophageal resection or the operative approach influences outcome for patients with adenocarcinoma of the gastroesophageal junction ( GEJ ) . Summary Background Data : While R0 resection remains the mainstay of curative treatment of patients with GEJ cancer , the optimal length of esophageal resection remains controversial . Methods : Patients with Siewert I , II , or III adenocarcinoma who underwent complete gross resection without neoadjuvant therapy were identified from a prospect ively maintained data base . Proximal margin lengths were recorded ex vivo as the distance from the gross tumor edge to the esophageal transection line . Operative approaches were grouped into gastrectomy ( limited esophagectomy ) or esophagectomy ( extended esophagectomy ) . Results : From 1985 through 2003 , 505 patients underwent R0/R1 gastrectomy ( n = 153 ) or esophagectomy ( n = 352 ) without neoadjuvant treatment . There were no differences in R1 resection rate , number of nodes examined or operative mortality between gastrectomy and esophagectomy . Univariate analysis found > 3.8 cm to be the ex vivo proximal margin length ( approximately 5 cm in situ ) most predictive of improved survival . Multivariable analysis in patients who underwent R0 resection with ≥15 lymph nodes examined ( n = 275 ) found the number of positive lymph nodes , T stage , tumor grade , and ex vivo proximal margin length > 3.8 cm to be independent prognostic factors . Subset analysis found that the benefit associated with > 3.8 cm margin was limited to patients with T2 or greater tumors and ≤6 positive lymph nodes . Conclusions : In patients not receiving neoadjuvant therapy , the goal for patients with adenocarcinoma of the GEJ should be R0 resection including at least 15 lymph nodes , preferably with 5 cm of grossly normal in situ proximal esophagus for those with ≤6 positive lymph nodes . The operative approach may be individualized to achieve these goals BACKGROUND The outlook for patients with oesophageal cancer undergoing surgical resection with curative intent is poor . We aim ed to assess the effects of preoperative chemotherapy on survival , dysphagia , and performance status in this group of patients . METHODS 802 previously untreated patients with resectable oesophageal cancer of any cell type were r and omly allocated either two 4-day cycles , 3 weeks apart , of cisplatin 80 mg/m(2 ) by infusion over 4 h plus fluorouracil 1000 mg/m(2 ) daily by continuous infusion for 4 days followed by surgical resection ( CS group , n=400 ) , or resection alone ( S group , 402 ) . Clinicians could choose to give preoperative radiotherapy to all their patients irrespective of r and omisation . Primary outcome measure was survival time . Analysis was by intention to treat . FINDINGS No patients dropped out of the study . Resection was microscopically complete in 233 ( 60 % ) of 390 assessable CS patients and 215 ( 54 % ) of 397 S patients ( p<0.0001 ) . Postoperative complications were reported in 146 ( 41 % ) CS and 161 ( 42 % ) S patients . Overall survival was better in the CS group ( hazard ratio 0.79 ; 95 % CI 0.67 - 0.93 ; p=0.004 ) . Median survival was 512 days ( 16.8 months ) in the CS group compared with 405 days ( 13.3 months ) in the S group ( difference 107 days ; 95 % CI 30 - 196 ) , and 2-year survival rates were 43 % and 34 % ( difference 9 % ; 3 - 14 ) . INTERPRETATION Two cycles of preoperative cisplatin and fluorouracil improve survival without additional serious adverse events in the treatment of patients with resectable oesophageal cancer BACKGROUND Esophageal resection represents a major surgical and physiologic insult carrying major morbidity and mortality . We present the results of esophagectomy in a specialist unit with emphasis on early complications and their management . STUDY DESIGN From January 4 , 1990 through January 6 , 2000 , 228 patients have undergone Ivor Lewis subtotal esophagectomy with two-field lymphadenectomy for malignancy under the care of one surgeon . The median age was 64 years ( range 39 to 77 years ) , with a male to female ratio of 2.3:1 and a predominance of adenocarcinoma ( n = 146 ) compared with squamous cell carcinoma ( n = 75 ) and other tumors ( n = 7 ) . Detailed prospect i ve data were collected on preoperative status , operative parameters , and postoperative complications . RESULTS Median ICU stay was 1 day ( range 1 to 47 days ) and the median postoperative hospital stay in patients surviving surgery ( n= 219 ) was 13 days ( range 9 to 159 days ) . There were 119 separate postoperative complications occurring in 45 % of patients ( 102 of 228 ) , comprising predominantly pulmonary morbidity . Major respiratory complications ( 17 % ) were significantly associated with poor preoperative spirometry ( p = 0.002 ) and a history of smoking ( p = 0.03 ) . Seven percent of patients ( 16 of 228 ) suffered cardiovascular or thromboembolic complications . Major surgical complications occurred in 10 % of patients ( 22 of 228 ) including mediastinal leaks in 4 % . Isolated anastomotic leaks ( 2 % ) were successfully treated conservatively in all cases ; extensive leaks from ischemic gastric conduits ( 1 % ) or gastrotomy dehiscence ( 1 % ) underwent further exploration and either local repair or resection and exclusion . Reoperation for hemostasis was required in 3 % ( 6 of 228 ) and only 1 % of patients ( 2 of 228 ) developed chyle leaks . Thirty-day mortality was 2 % , rising to 4 % for in-hospital mortality . The nine fatalities were significantly older ( p = 0.02 ) than those who survived and 67 % ( 6 of 9 ) had suffered primary surgical complications . CONCLUSIONS Overall morbidity after radical esophagectomy is high , but early recognition and aggressive management of complications can minimize subsequent mortality . Concentration of facilities and surgical expertise in specialist units together with more careful patient selection can decrease mortality further Transthoracic esophagectomy ( TT ) has been championed as a better cancer operation than transhiatal esophagectomy ( TH ) because the approach facilitates meticulous wide tumor excision and lymphadenectomy . However , neoadjuvant chemoradiotherapy ( CRTS ) and chemotherapy ( CS ) have been reported to improve outcomes , and we aim ed to compare outcomes after multimodal therapy related to the operative approach . One hundred and fifty-one consecutive patients were studied prospect ively . All patients were staged with computed tomography and endoluminal ultrasound , and treatment decisions were related to stage and performance status . One hundred and nineteen TT ( median age 58 years , 92 male , 54 CRTS , 65 CS ) were performed compared to 32 TH ( median age 57 year , 27 male , 14 CRTS , 18 CS ) . Primary outcome measure was survival . Post-operative morbidity and mortality were 54 % and 4 % , respectively , after TT compared with 59 % and 6 % after TH ( chi2 0.239 df 1 , P=0.625 ) . Recurrent cancer was no less frequent after TT ( 52 % ) than after TH ( 37.5 % , chi2 2.151 df=1 , P=0.142 ) . Cumulative uncorrected 5-year survival was 34 % after TT compared with 53 % after TH ( log rank 1.44 , df=1 , P=0.2298 ) . Median survival was also similar in lymph node positive patients ( TT vs. TH , 23 months vs. 22 months , respectively , log rank 0.25 , df=1 , P=0.6199 ) . Despite the fact that patients receiving multimodal therapy and a TH esophagectomy were less fit , operative morbidity , mortality and recurrence were similar , and survival did not differ significantly when compared with multimodal TT esophagectomy SUMMARY Several techniques for esophageal resections have been reported . However , clear clinical evidence is still lacking whether any of the procedures is superior to the others regarding morbidity and mortality in the early postoperative period . Two operative approaches for esophageal carcinoma , transhiatal and transthoracic , were compared with respect to operative morbidity , mortality and systemic inflammatory response . In our prospect i ve study between 2000 and 2002 83 patients were investigated . In a retrospective post hoc analysis patients were divided into two groups due to the performed operational procedure , transhiatal ( TH ) or transthoracic ( TT ) . Multiple Organ Dysfunction Score ( MODS ) was monitored daily ( t1,t2,t3 ) . Serum procalcitonin ( PCT ) levels were determined on admission to the ICU ( t0 ) , then 24 hourly ( t24,t48,t72 ) . Microalbuminuria ( M : Cr ) was measured before ( tp ) , and after surgery ( t0,t6,t24,t48,t72 ) . For statistical analysis Wilcoxon rank sum test , Mann-Whitney U-test and chi-square test were used as appropriate . We examined 52 patients in the TH group , and 31 patients in the TT group . There was no significant difference between the two groups regarding age , male/female ratio , and SAPS II scores . Operations lasted significantly longer in the TT group : 375 ( 300 - 480 ) min compared to the TH group 240 375 ( 180 - 319 ) min , P < 0.001 . ICU mortality was similar in both groups ( TH : 46 survivors/6 non-survivors ; TT : 27 survivors/4 non-survivors ; P = 0.607 , respectively ) . Daily MODS did not differ significantly between the two groups . The observed inflammatory markers ( PCT and M : Cr ) followed the pattern we described earlier , without significant difference . In this study there was no difference in the clinical and biochemical variables of the patients between the transthoracic and transhiatal groups . The observed early postoperative morbidity and mortality may indicate , that both procedures can be considered as procedures with similar postoperative risk OBJECTIVE To review the authors ' clinical experience with transhiatal esophagectomy ( THE ) and the refinements in this procedure that have evolved . BACKGROUND Increased use of THE during the past two decades has generated controversy about the merits and safety of this approach compared with transthoracic esophageal resection . The authors ' large THE experience provides a valuable basis for benchmarking data regarding the procedure . METHODS The results of THE were analyzed retrospectively using the authors ' prospect ively established esophageal resection data base and follow-up information on these patients . RESULTS From 1976 to 1998 , THE was performed in 1085 patients , 26 % with benign disease and 74 % with cancer . The procedure was possible in 98.6 % of cases . Stomach was the esophageal substitute in 96 % . The hospital mortality rate was 4 % . Blood loss averaged 689 cc . Major complications were anastomotic leak ( 13 % ) , atelectasis/pneumonia ( 2 % ) , intrathoracic hemorrhage , recurrent laryngeal nerve paralysis , chylothorax , and tracheal laceration ( < 1 % each ) . Actuarial survival of patients with carcinoma equaled or exceeded that reported after transthoracic esophagectomy . Late functional results were good or excellent in 70 % . With preoperative pulmonary and physical conditioning , a side-to-side stapled cervical esophagogastric anastomosis ( <3 % incidence of leak ) , and postoperative epidural anesthesia , the need for an intensive care unit stay has been eliminated and the length of stay reduced to 7 days . CONCLUSION THE is possible in most patients requiring esophageal resection and can be performed with greater safety and fewer complications than the traditional transthoracic approaches BACKGROUND The Department of Veterans Affairs National Surgical Quality Improvement Program is a unique re source to prospect ively analyze surgical outcomes from a cross-section of surgical services nationally . We used this data base to assess risk factors for morbidity and mortality after esophagectomy in Veterans Affairs Medical Centers from 1991 to 2001 . METHODS A total of 1,777 patients underwent an esophagectomy at 109 Veterans Affairs hospitals with complete in-hospital and 30-day outcomes recorded . Bivariate and multivariable analyses were completed . RESULTS Thirty-day mortality was 9.8 % ( 174/1,777 ) and the incidence of one or more of 20 predefined complications was 49.5 % ( 880/1,777 ) . The most frequent postoperative complications were pneumonia in 21 % ( 380/1,777 ) , respiratory failure in 16 % ( 288/1,777 ) , and ventilator support more than 48 hours in 22 % ( 387/1,777 ) . Preoperative predictors of mortality based on multivariable analysis included neoadjuvant therapy , blood urea nitrogen level of more than 40 mg/dL , alkaline phosphatase level of more than 125 U/L , diabetes mellitus , alcohol abuse , decreased functional status , ascites , and increasing age . Preoperative factors impacting morbidity were increasing age , dyspnea , diabetes mellitus , chronic obstructive pulmonary disease , alkaline phosphatase level of more than 125 U/L , lower serum albumin concentration , increased complexity score , and decreased functional status . Intraoperative risk factors for mortality included the need for transfusion ; intraoperative risk factors for morbidity included the need for transfusion and longer operative time . CONCLUSIONS These data constitute the largest prospect i ve outcomes cohort in the literature and document a near 50 % morbidity rate and 10 % mortality rate after esophagectomy . Data from this study can be used to better stratify patients before esophagectomy BACKGROUND Controversy exists about the best surgical treatment for esophageal carcinoma . METHODS We r and omly assigned 220 patients with adenocarcinoma of the mid-to-distal esophagus or adenocarcinoma of the gastric cardia involving the distal esophagus either to transhiatal esophagectomy or to transthoracic esophagectomy with extended en bloc lymphadenectomy . Principal end points were overall survival and disease-free survival . Early morbidity and mortality , the number of quality -adjusted life-years gained , and cost effectiveness were also determined . RESULTS A total of 106 patients were assigned to undergo transhiatal esophagectomy , and 114 to undergo transthoracic esophagectomy . Demographic characteristics and characteristics of the tumor were similar in the two groups . Perioperative morbidity was higher after transthoracic esophagectomy , but there was no significant difference in in-hospital mortality ( P=0.45 ) . After a median follow-up of 4.7 years , 142 patients had died--74 ( 70 percent ) after transhiatal resection and 68 ( 60 percent ) after transthoracic resection ( P=0.12 ) . Although the difference in survival was not statistically significant , there was a trend toward a survival benefit with the extended approach at five years : disease-free survival was 27 percent in the transhiatal-esophagectomy group , as compared with 39 percent in the transthoracic-esophagectomy group ( 95 percent confidence interval for the difference , -1 to 24 percent [ the negative value indicates better survival with transhiatal resection ] ) , whereas overall survival was 29 percent as compared with 39 percent ( 95 percent confidence interval for the difference , -3 to 23 percent ) . CONCLUSIONS Transhiatal esophagectomy was associated with lower morbidity than transthoracic esophagectomy with extended en bloc lymphadenectomy . Although median overall , disease-free , and quality -adjusted survival did not differ statistically between the groups , there was a trend toward improved long-term survival at five years with the extended transthoracic approach Objective To determine the impact of radical node dissection on the recurrence patterns and survival rates of patients with carcinoma of the esophagus . Summary Background Data The role of esophagectomy with radical lymphadenectomy in the treatment of esophageal cancer is controversial . Most centers favor a limited operation with no attempt at nodal clearance . However , disease recurrence and patient survival rates remain dismal with or without preoperative therapy . The authors postulate that a more radical node dissection would reduce local failure rates and enhance survival . Methods One hundred eleven patients with esophageal cancer underwent en bloc esophagectomy with radical lymph node dissection between 1988 and 1998 . In 90 % of patients the procedure was applied nonselectively and without any preoperative therapy . Patients were prospect ively followed up for recurrence patterns and survival . Results The 5-year survival rate including noncancer deaths was 40 % . The 5-year survival rates for patients with stage 1 , 2A , 2B , 3 , and 4 disease were 78 % , 72 % , 0 % , 39 % , and 27 % , respectively . Forty percent of patients had node-negative disease ( 5-year survival rate , 75 % ) , and 60 % had nodal metastases ( 5-year survival rate , 26 % ) . Recurrence occurred in 39 % of patients and was local in only 8 % . Conclusions Radical esophagectomy results in superior overall and stage-specific 5-year survival rates . Extensive node dissection has a positive impact on survival rates , particularly in patients with nodal metastases BACKGROUND The question whether transhiatal ( TH ) or transthoracic ( TT ) resection is most suited for the extirpation of an esophageal cancer remains unresolved . The present study compared the two approaches in a prospect i ve r and omized manner . PATIENTS AND METHODS Thirty-nine patients with carcinoma of the lower third of the esophagus who were clinical ly fit for either TH or TT resection were prospect ively r and omized to TH ( 20 patients ) and TT ( 19 patients ) resection . Patients of the two groups were comparable in age , sex , preoperative tumor staging , and pulmonary and cardiac risks for surgery . RESULTS There was no significant difference in the amount of blood loss between the two groups although intraoperative hypotension ( systolic < 80 mm Hg ) occurred more frequently in the TH group ( P < 0.001 ) . The mean operating time for the TH and TT groups were 174 minutes and 210 minutes , respectively ( P < 0.001 ) . There was no difference in postoperative ventilatory requirements , cardiopulmonary complication rates , and , mean hospital stay between the two groups . There was no 30-day mortality in either group but there were 3 hospital deaths in the TH group from bronchopneumonia ( 2 patients ) and disseminated malignancy ( 1 patient ) . The median survival rates were 16 and 13.5 months , respectively , for the TH and TT groups ( P = NS ) . CONCLUSIONS Although there was no demonstrable statistical difference in results between TH and TT approaches , the TT approach is preferred as it allowed for a more controlled operation INTRODUCTION Cancer of the oesophagus is a major problem in Yemen , where most of the patients present with advanced disease . Curative oesophageal resection for carcinoma may be carried out by either the transhiatal or transthoracic technique . The aims of this study were to compare the morbidity , mortality , short term outcome and long term survival of the two techniques in the treatment of oesophageal carcinoma . METHODS From March 1998 to July 2004,118 patients with cancer of the oesophagus were studied . The tumours in 84 patients were resected by transhiatal oesophagectomy ( 43 ) and transthoracic oesophagectomy ( 41 ) . RESULTS The two groups were comparable in terms of age , sex , location of the tumours , risk factors and stage of the disease . There was no significant difference in the mean intensive care unit stay , blood transfusion and mean hospital stay . Anastomotic leak was higher in the transhiatal oesophagectomy group than transthoracic group ( 21 percent versus 12 percent , p-value is equal to 0.001 ) . Recurrent laryngeal nerve lesion was present in 18.6 percent of the transhiatal group and absent in the transthoracic group . The overall hospital mortality was 8.3 percent with no significant difference between the two groups ( transhiatal 9.3 percent versus transthoracic 7.3 percent , p-value is equal to 0.742 ) . CONCLUSION Transhiatal oesophagectomy was associated with a higher incidence of anastomotic complications and recurrent laryngeal nerve lesions , but there was no significant difference in the mortality between the two groups Objective : This study aim ed at : ( 1 ) documenting the evolution of surgical results of esophagectomy in a high-volume center , ( 2 ) identifying predictive factors of pulmonary complications and mortality , and ( 3 ) examining whether preoperative chemoradiation therapy would complicate postoperative recovery . Summary Background Data : Pulmonary complications and mortality rate after esophagectomy remain substantial , and factors responsible have not been adequately studied . Neoadjuvant chemoradiation is widely used ; it is hypothesized that this may lead to adverse postoperative outcome . Methods : Prospect ively collected data were used to analyze outcome in 421 patients with intrathoracic squamous cell esophageal cancer who underwent resection . Logistic regression analyses determined independent predictors of pulmonary complications and death . Two time periods were compared : period I ( January 1990 to June 1995 ) and period II ( July 1995 to December 2001 ) . In the later period , neoadjuvant chemoradiation therapy was introduced . Results : Transthoracic resections were carried out in 83 % of patients . Neoadjuvant chemoradiation was given to 42 % of patients in period II . Major pulmonary complications occurred in 15.9 % , and were primarily responsible for 55 % of hospital deaths . Thirty-day and hospital mortality rates were 1.4 % and 4.8 % , respectively . Logistic regression analysis identified age , operation duration , and proximal tumor location as risk factors for pulmonary complications , whereas advanced age and higher blood loss were predictive of mortality . Chemoradiation did not lead to worse outcome . When period I and II were compared , hospital mortality rate reduced from 7.8 % to 1.1 % , P = 0.001 , with correspondingly less blood loss ( median blood loss was 700 ml ( range : 200–2700 ( period I ) and 450 ml ( range : 100–7000 ) ( period II ) , P < 0.01 ) . Conclusion : A 1.1 % mortality rate was achieved in the last 6 years of the study period . Preoperative chemoradiation did not result in worse outcome . Reduction in mortality rate correlated with decreased blood loss BACKGROUND We performed a multi-institutional r and omized trial comparing preoperative chemotherapy followed by surgery with surgery alone for patients with local and operable esophageal cancer . METHODS Preoperative chemotherapy for patients r and omly assigned to the chemotherapy group included three cycles of cisplatin and fluorouracil . Surgery was performed two to four weeks after the completion of the third cycle ; patients also received two additional cycles of chemotherapy after the operation . Patients r and omly assigned to the immediate-surgery group underwent the same surgical procedure . The main end point was overall survival . RESULTS Of the 440 eligible patients with adequate data , 213 were assigned to receive preoperative chemotherapy and 227 to undergo immediate surgery . After a median possible study time of 55.4 months , there were no significant differences between the two groups in median survival : 14.9 months for the patients who received preoperative chemotherapy and 16.1 months for those who underwent immediate surgery ( P=0.53 ) . At one year , the survival rate was 59 percent for those who received chemotherapy and 60 percent for those who had surgery alone ; at two years , survival was 35 percent and 37 percent , respectively . The toxic effects of chemotherapy were tolerable , and the addition of chemotherapy did not appear to increase the morbidity or mortality associated with surgery . There were no differences in survival between patients with squamous-cell carcinoma and those with adenocarcinoma . Weight loss was a significant predictor of poor outcome ( P=0.03 ) . With the addition of chemotherapy , there was no change in the rate of recurrence at locoregional or distant sites . CONCLUSIONS Preoperative chemotherapy with a combination of cisplatin and fluorouracil did not improve overall survival among patients with epidermoid cancer or adenocarcinoma of the esophagus BACKGROUND Transhiatal esophagectomy is a popular method of resection because of its reported lower morbidity and mortality and similar survival rates compared to transthoracic esophagectomy . A review of recent experience with these two procedures for resection of distal esophageal and cardia adenocarcinoma is reported . METHODS From 1988 to 1994 , 48 patients with adenocarcinoma of the distal esophagus and gastric cardia were resected with intent to cure , 32 by transhiatal esophagectomy ( group 1 ) and 16 by transthoracic esophagectomy ( group II ) . The two groups were comparable in terms of patient demographics , preoperative risk factors , tumor stage , tumor differentiation , and involvement of resection margins ( all not significant [ NS ] ) . RESULTS There was no significant difference in median intensive care unit stay , median hospital stay , incidence of postoperative anastomotic leak , and stricture . Respiratory complications were higher in group I ( 41 % versus 6 % , P = 0.01 ) . Hospital mortality was not significantly different for the two groups ( group I 3.1 % versus group II 0 % , NS ) . Actuarial 5-year survival rates ( Kaplan-Meier ) were 12 % for group I and 39 % for group II ( NS ) . CONCLUSIONS These results suggest that when compared with transhiatal esophagectomy , the transthoracic approach is at least as safe , has comparable complication and survival rates , and remains an acceptable procedure for resection of adenocarcinomas of the distal esophagus and gastric cardia Objective : To determine whether extended transthoracic esophagectomy for adenocarcinoma of the mid/distal esophagus improves long-term survival . Background : A r and omized trial was performed to compare surgical techniques . Complete 5-year survival data are now available . Methods : A total of 220 patients with adenocarcinoma of the distal esophagus ( type I ) or gastric cardia involving the distal esophagus ( type II ) were r and omly assigned to limited transhiatal esophagectomy or to extended transthoracic esophagectomy with en bloc lymphadenectomy . Patients with peroperatively irresectable/incurable cancer were excluded from this analysis ( n = 15 ) . A total of 95 patients underwent transhiatal esophagectomy and 110 patients underwent transthoracic esophagectomy . Results : After transhiatal and transthoracic resection , 5-year survival was 34 % and 36 % , respectively ( P = 0.71 , per protocol analysis ) . In a subgroup analysis , based on the location of the primary tumor according to the resection specimen , no overall survival benefit for either surgical approach was seen in 115 patients with a type II tumor ( P = 0.81 ) . In 90 patients with a type I tumor , a survival benefit of 14 % was seen with the transthoracic approach ( 51 % vs. 37 % , P = 0.33 ) . There was evidence that the treatment effect differed depending on the number of positive lymph nodes in the resection specimen ( test for interaction P = 0.06 ) . In patients ( n = 55 ) without positive nodes locoregional disease-free survival after transhiatal esophagectomy was comparable to that after transthoracic esophagectomy ( 86 % and 89 % , respectively ) . The same was true for patients ( n = 46 ) with more than 8 positive nodes ( 0 % in both groups ) . Patients ( n = 104 ) with 1 to 8 positive lymph nodes in the resection specimen showed a 5-year locoregional disease-free survival advantage if operated via the transthoracic route ( 23 % vs. 64 % , P = 0.02 ) . Conclusion : There is no significant overall survival benefit for either approach . However , compared with limited transhiatal resection extended transthoracic esophagectomy for type I esophageal adenocarcinoma shows an ongoing trend towards better 5-year survival . Moreover , patients with a limited number of positive lymph nodes in the resection specimen seem to benefit from an extended transthoracic esophagectomy Among 210 patients who underwent resection for carcinoma of the middle and lower thirds of the thoracic esophagus , 38 were selected for a transhiatal nonthoracotomy approach . Compared with the 172 resections through a transthoracic route , there was no difference in age , sex , location , and differentiation of tumor . In the transhiatal group , excessive bleeding and tumor perforation as a result of blunt dissection each occurred in seven patients ( 18 percent ) . Recurrent nerve injury was noted in five patients ( 13 percent ) , but tracheal damage and chylothorax were avoided . The incidences of operative mortality and postoperative complications were similar in both groups . Survival by life-table analysis showed the transhiatal approach to be inferior to the transthoracic one . This nonr and omized study did not answer the question as to whether respiratory complications were lessened but did show a significant number of intraoperative complications when the transhiatal approach was used . The results indicated that survival was better when resection was performed through the chest |
1,371 | 24,848,893 | We found that laparoscopy in women with acute lower abdominal pain , non-specific lower abdominal pain or suspected appendicitis led to a higher rate of specific diagnoses being made and a lower rate of removal of normal appendices compared with open appendicectomy only .
Hospital stays were shorter .
No evidence showed an increase in adverse events when any of these strategies were used | BACKGROUND This is an up date d version of the original review , published in Issue 1 , 2011 , of The Cochrane Library .
Acute lower abdominal pain is common , and making a diagnosis is particularly challenging in premenopausal women , as ovulation and menstruation symptoms overlap with symptoms of appendicitis , early pregnancy complications and pelvic infection .
A management strategy involving early laparoscopy could potentially provide a more accurate diagnosis , earlier treatment and reduced risk of complications .
OBJECTIVES To evaluate the effectiveness and harms of laparoscopy for the management of acute lower abdominal pain in women of childbearing age . | Background A prospect i ve study including 272 patients with suspected appendicitis was performed . The aims were to evaluate the representativity of the study group and to compare diagnostic and therapeutic laparoscopy with conventional appendicectomy Abstract . A prospect i ve , r and omized trial was performed to compare open appendectomy with laparoscopic appendectomy in men with a clinical diagnosis of acute appendicitis . Sixty-four patients with a median age of 25 years ( range 18–84 years ) were r and omized to open appendectomy ( n = 31 ) or laparoscopic ( n = 33 ) appendectomy . Of the 64 men , 56 ( 87.5 % ) had appendicitis ( 27 open , 29 laparoscopic procedures ) . The mean operating times were 50.6 ± 3.7 minutes ( ± SEM ) for open and 58.9 ± 4.0 minutes for laparoscopic appendectomy ( p = 0.13 ) . Five ( 15 % ) patients r and omized to laparoscopic appendectomy had an open operation . The mean postoperative hospital stay was significantly longer for open appendectomy ( 3.8 ± 0.4 days ) than for laparoscopic appendectomy ( 2.9 ± 0.3 days ) ( t = 2.05,df = 62,p = 0.045 ) . The complication rate after open appendectomy ( 25.8 % ) was not significantly different from that after laparoscopic appendectomy ( 12.1 % ) . There was a single postoperative death due to a pulmonary embolus in the laparoscopic group and a single death due to cardiac and renal failure in the open group . The mean time to return to normal activities was significantly longer following open appendectomy ( 19.7 ± 2.4 days ) than after laparoscopic appendectomy ( 10.4 ± 0.9 days ) , ( t = 3.75,df = 49,p = 0.001 ) . In conclusion , laparoscopic appendectomy in men has significant advantages in terms of a more rapid recovery compared to open appendectomy . There were no significant disadvantages to laparoscopic appendectomy compared to open appendectomy Aim : To see whether laparoscopy improves the accuracy of a clinical diagnosis of acute appendicitis in women of reproductive age , and to determine what the long-term sequelae are of not removing an appendix deemed at laparoscopy to be normal . Method : The initial part of the study was undertaken during 1991–1992 . Female patients between 16 and 45 years were eligible for inclusion once a clinical decision had been made to perform an appendicectomy for suspected acute appendicitis . Following consent , patients were r and omized into two groups . One group had open appendicectomy , as planned . The other group had laparoscopy , followed by open appendicectomy only if the appendix was seen to be inflamed or was not visualized . The end points for the study were the clinical outcomes of all patients , and the results of histology , where appropriate . An attempt was made to contact all patients at 10 years to determine whether they had had a subsequent appendicectomy , or had been diagnosed with another abdominal condition that might be relevant to the initial presentation in 1991–1992 . Results : Laparoscopic assessment was correct in all cases in which the appendix was visualized . Diagnostic accuracy was improved from 75 % to 97 % . Laparoscopy was associated with no added complications , no increase in hospital stay in patients who went on to appendicectomy , and a reduction in hospital stay for those who underwent laparoscopy alone . No patients developed a problem over the 10-year follow-up period from having a normal-looking appendix not removed at laparoscopy . Conclusion : Laparoscopic assessment of the appendix is reliable , and to leave a normal-looking appendix at laparoscopy does not appear to cause any long-term problems INTRODUCTION The aim of the study is to analyse the own data and try to discuss if laparoscopic appendectomy offers any advantages in treating young women suffering from pain in right lower abfdominal quadrant . MATERIAL S AND METHODS The study was conducted on 148 patients admitted from October 1993 to December 1998 with diagnosis of of pain in right iliac fossa and operated on with a laparoscopic ( LA group : 75 cases ) or open approach ( OA group : 73 cases ) . Patients were prospect ively r and omized on the surgical approach adopted , following a r and omized list . RESULTS The operative time in LA group was significantly ( p < 0.001 ) longer ( 87.2 minutes ) than for OA group ( 65.2 minutes ) . In 2 patients ( 2.7 % ) the operation had to be converted . Diagnosis had remained unknown in 16 patients ( 21.9 % ) of OA group , in spite of only one case ( 1.4 % ) with laparoscopic technique . We did n't observed intraoperative complications . Pain in the first and second postoperative days , evaluated on the use of pain medication , was significantly less in patients in group LA ( p < 0.01 ) . There were no deaths . Postoperative complications occurred in 4 patients ( 5.5 % ) of group LA , and in 8 patients ( 10.9 % ) of group OA . Hospital stay was significantly shorter for those having laparoscopic appendectomy ( p < 0.001 ) . DISCUSSION The main advantages of laparoscopic appendectomy consist more in diagnostic accuracy , than in less postoperative pain , less hospital stay and less postoperative complications . CONCLUSION Laparoscopic appendectomy is a safe and accurate approach The benefits of laparoscopic appendectomy appear to be controversial . Since 1994 , several abdominal procedures have been completed by using the needlescopic technique , but there appear to be no prospect i ve studies to demonstrate the perceived benefits of needlescopic appendectomy . The authors compared open , laparoscopic , and needlescopic appendectomy in a r and omized fashion with regard to duration of surgery , length of hospitalization , analgesic dosage , and surgery-associated complications . From March to July 1998 , 75 patients admitted at the emergency station of the authors ' hospital with a final diagnosis of acute appendicitis without tumor formation were r and omized to receive one of the three treatment categories : open ( OA ) , laparoscopic ( LA ) , and needlescopic ( nLA ) appendectomy . Laparoscopic and needlescopic appendectomy were performed by using a three-port technique , although the size of the trocar used varied . There were 26 patients in the OA group , 23 in the LA group , and 26 in the nLA group . The mean operation duration s for the OA , LA , and nLA groups were 55.4 ± 28.0 minutes , 69.1 ± 48.8 minutes , and 62.3 ± 26.3 minutes , respectively , and these were not significantly different from one another . The mean number of the analgesic doses ( Pethidine 1 mg/kg ) required was 1.3 ± 1.2 mg/kg , 0.5 ± 0.8 mg/kg , and 0.2 ± 0.6 mg/kg , respectively . Significant differences were noted when comparing the OA with the LA or nLA groups ( OA vs. LA , P = 0.02 ; OA vs. nLA , P = 0.0002 ; LA vs. nLA , P = 0.06 ) . The mean oral intake duration s were 32.2 ± 16.9 hours , 21.0 ± 14.6 hours , and 20.8 ± 16.4 hours , respectively , after surgery for the OA , LA , and nLA groups , and the between-group differences were statistically significant for the OA versus LA group ( P = 0.004 ) and for the OA versus nLA group ( P = 0.003 ) . The mean duration s of hospitalization for the OA , LA , and nLA groups were 3.6 ±1.8 days , 2.8 ± 1.4 days , and 2.4 ± 0.9 days , and difference was detected between the OA and the nLA groups ( P = 0.02 ) . The OA group rendered a greater wound-complication rate and ileus than did the other two groups , but the differences were not detected between the three categories ( P = 0.065 , 0.6935 ) . The result of the current study confirmed that the nLA procedure is a feasible and safe one . The nLA procedure provided substantial advantages over the OA procedure in the context s of diminished postoperative pain and shorter hospital stay without significant increases in postoperative complication rate or surgical time BACKGROUND Laparoscopic appendectomy is feasible , but whether it confers any advantage to patients with acute appendicitis is not known . We performed a r and omized controlled trial to compare results of laparoscopic and open appendectomy in patients with signs and symptoms suggesting acute appendicitis who were seen by one surgical team . METHODS Sixty-two consecutive patients were r and omized , 30 to laparoscopy and 32 to a classical open appendectomy . Postoperative recovery , complications , and return to normal activities were compared in the two groups . RESULTS The laparoscopy group were discharged earlier ( 2.5 vs 3.8 days , p less than 0.01 ) . Postoperative complications were more frequent after open appendectomy . Follow-up showed less pain , shorter bed stay at home , and faster return to work and sport after laparoscopic appendectomy . CONCLUSIONS This prospect i ve r and omized study shows that laparoscopic appendectomy is superior to open appendectomy in terms of hospital stay , postoperative complications , and return to normal activities and is recommended as the approach of choice in the management of acute appendicitis Hyperkalaemia with ECG changes had been noted during prolonged carbon dioxide pneumoperitoneum in pigs . We have compared plasma potassium concentrations during surgery in 11 patients allocated r and omly to undergo either laparoscopic or open appendectomy and in another 17 patients allocated r and omly to either carbon dioxide pneumoperitoneum or abdominal wall lifting for laparoscopic colectomy . Despite an increasing metabolic acidosis , prolonged carbon dioxide pneumoperitoneum result ed in only a slight increase in plasma potassium concentrations , which was both statistically and clinical ly insignificant . Thus hyperkalaemia is unlikely to develop in patients with normal renal function undergoing carbon dioxide pneumoperitoneum for laparoscopic surgery Background The aim of this study was to study the value of diagnostic laparoscopy prospect ively in fertile women scheduled for acute appendectomy . Methods For this study , 110 women , with acute abdominal pain ages 15 to 47 years , in whom the surgeon had decided to perform an appendectomy , were r and omized to either open appendectomy or diagnostic laparoscopy , then open appendectomy if necessary . Results Appendicitis was diagnosed in 66 % of the women after open surgery , and in 73 % after laparoscopy . During laparoscopy , was appendicitis misdiagnosed in only 7 % of the women , from whom the appendix unnecessarily removed , whereas 34 % in the open surgery group had a healthy appendix removed . No appendicitis was missed in the laparoscopic group . The relative risk of removing a healthy appendix in open surgery was 6.6 relative risk ( range , 2–21 C.I. ) as compared with laparoscopy . Among the women with a healthy appendix , a gynecologic diagnosis was found in 73 % after laparoscopy , as compared with 17 % after open surgery . Conclusions Laparoscopy reduces unnecessary appendectomies and improves diagnosis in fertile women BACKGROUND Laparoscopic appendectomy has now gained wider acceptance in clinical practice , particularly in the treatment of women with right iliac fossa pain . However , the precise role of laparoscopic appendectomy in men is unclear , and this study was therefore undertaken to examine this specific issue in a prospect i ve r and omized trial . METHODS One hundred men between the ages of 16 and 65 years who had suspected appendicitis were recruited and r and omized to undergo either open or laparoscopic appendectomy . Both groups were compared in terms of their clinical parameters , duration of anesthetic and operation times , postoperative pain , duration of ileus , and length of hospital stay . RESULTS The histologic confirmation of appendicitis was present in 94 % of the cases for both groups of patients . Laparoscopic appendectomy required significantly longer anesthetic time ( 72.5 minutes versus 55 minutes ) and actual operating time ( 45 minutes versus 25 minutes ) compared with open appendectomy . Postoperative pain as measured by visual analog scale on postoperative days 1 and 2 were not significantly different between the patients who underwent laparoscopic and open surgery with values of 4.7 versus 4.4 and 2.1 versus 2.2 , respectively . Also no significant difference was seen between the laparoscopic and open appendectomy groups in the recovery of bowel function ( 24.7 hours versus 21 hours ) and in the length of hospital stay ( 4.9 days versus 5.3 days ) . CONCLUSIONS The results of this prospect i ve r and omized trial showed that there were no significant advantages of laparoscopic appendectomy over open appendectomy for the treatment of male patients with suspected appendicitis . We recommend that the use of laparoscopy be limited to men with atypical pain of uncertain diagnosis and in obese patients The diagnosis of appendicitis remains uncertain in female patients and laparoscopy has been suggested as a valid diagnostic tool . The laparoscopic approach has recently also been proposed for the treatment of acute appendicitis , though its real value is still under debate . A clinical and economic prospect i ve evaluation of laparoscopic surgery over a 1-year period in female patients is reported . The study involved 38 patients presenting with signs of appendicitis and assigned to open ( 18 ) or laparoscopic surgery ( 20 ) . The two groups were comparable as regards age and clinical presentation of the disease . The duration of the procedures was similar ( 60 min ) . Morbidity was comparable ( 3 vs 2 ) . The ratio of negative appendectomy ( 50 % vs 44 % ) was also similar , but the laparoscopic approach enabled a higher number of certain diagnoses ( 9/10 vs 3/8 p>0.05 ) . No significant differences were observed in the median postoperative stay ( 3 days for laparoscopy and 4 for surgery ) or in the days needed to return to normal activity ( 15 vs 18 ) . The cosmetic satisfaction was higher for the laparoscopic patients . The cost of the laparoscopic approach , however , was much higher than for conventional surgery . Our results suggest that laparoscopy is a useful diagnostic tool in female patients , but that laparoscopic appendectomy should be considered with some caution in times of restricted financial re sources Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance , and its use remains controversial Background The role of laparoscopy in the management of patients with suspected acute appendicitis remains controversial . It has been suggested that laparoscopy is useful mainly in young women of reproductive age because of the high incidence of wrong diagnosis in these patients . Methods Different management protocol s for patients with suspected acute appendicitis were prospect ively used in male and female patients ; women of reproductive age were treated laparoscopically , while men were r and omised to open or laparoscopic appendectomy . Results From September 2002 to September 2005 , 132 patients —54 women and 78 men — with suspected acute appendicitis were treated according to the protocol . The incidence of wrong diagnosis in female patients was high ( 26 % and the conversion rate low ( 5.5 % ) . In contrast , in the laparoscopic male subgroup , these rates showed a reverse relationship ( 5.2 % and 18.5 % , respectively ) . Morbidity did not differ between female and male patients or between the 2 arms of the male group . Laparoscopic appendectomy took longer to perform without affecting significantly the needs for postoperative analgesia , the duration of hospital stay and the time to return to normal activities when compared with open appendectomy in men . Conclusion Laparoscopic appendectomy is at least as safe as the open procedure in the male population , although it does not appear to offer any obvious advantage over the open procedure . The diagnostic advantage that laparoscopy offers to fertile women makes the procedure attractive for this population OBJECTIVE To compare the efficacy of laparoscopic appendectomy ( LA ) and open appendectomy ( OA ) in the treatment of acute appendicitis . DESIGN A prospect i ve r and omized trial . SETTING A university teaching hospital . PATIENTS Eighty-one patients with a diagnosis of acute appendicitis were prospect ively r and omized to undergo either LA or OA . The two groups were matched for age and sex . INTERVENTIONS LA or OA . MAIN OUTCOME MEASURES Number of days in hospital and time to full recovery . RESULTS The mean hospital stay for LA was 3.23 days compared with 3.03 days for OA ( p < 0.001 ) . The mean number of narcotic injections required for patients in the LA group was 4.05 compared with 5.58 for patients in the OA group ( p < 0.001 ) . The mean time to complete recovery for patients in the LA group was 9.0 days compared with 16.2 days for patients in the OA group ( p < 0.001 ) . The mean operative time for LA was 73.8 minutes compared with 45.0 minutes for OA ( p < 0.001 ) . Three patients in the LA group had intra-abdominal abscesses ( p > 0.25 ) . No significant difference in wound infection rates was demonstrated ( p > 0.05 ) . Similarly , pain scores at 7 and 28 days showed no significant difference ( p > 0.05 ) . CONCLUSIONS With LA significantly fewer narcotic injections are required and there is a more rapid return to normal activities . LA takes longer to perform and was associated with three intra-abdominal abscesses . In cases of simple acute appendicitis the hospital stay for LA is significantly shorter Objective The authors compare open and laparoscopic appendectomy in a r and omized fashion with regard to length of operation , complications , hospital stay , and recovery time . Methods Adult patients ( older than 14 years of age ) with the diagnosis of acute appendicitis were r and omized to either open or laparoscopic appendectomy over a 9-month period . All patients received preoperative antibiotics . The operative time was calculated as beginning with the incision and ending when the wound was fully closed . Patients that were converted from laparoscopic to open appendectomy were considered a separate group . Return to normal activity and work were determined by question ing during postoperative clinic , telephone , or mailed question naire . Results There was a total of 169 patients r and omized , 88 to the open and 81 to the laparoscopic group . The groups were similar demographically . Of the 81 laparoscopic patients , 13 ( 16 % ) were converted to open . In the open group , 70 patients ( 79.5 % ) had acute appendicitis and 21 ( 23.9 % ) had perforative appendicitis . In the laparoscopic group , 62 patients ( 76.5 % ) had acute appendicitis and 10 ( 12.3 % ) had perforative appendicitis . There was no statistical difference in the return to activity or work between the laparoscopic and open groups . The operative time was significantly longer in the laparoscopic group ( 102.2 minutes vs. 81.7 minutes , p < 0.01 ) . The hospital stay of 2.2 days in the laparoscopic group and 4.3 days in the open group was statistically different ( p = 0.007 ) . There was no difference in the hospital stay for those with acute appendicitis ( 1.89 days vs. 2.61 days , p = 0.067 ) compared with those with a normal appendix but with pelvic inflammatory disease ( 1.1 days vs. 2.3 days , p = 0.11 ) . There was a significant difference in patients with perforative appendicitis ( 1.5 days vs. 9.5 days , p < 0.01 ) . The hospital cost for patients having laparoscopic appendectomy was $ 6077 and for an open appendectomy $ 7227 ( p = 0.164 ) . There were no increased complications associated with the laparoscopic technique . Conclusion Laparoscopic appendectomy is comparable to open appendectomy with regard to complications , hospital stay , cost , return to activity , and return to work . There was a greater operative time involved with the laparoscopic technique . Laparoscopic appendectomy does not offer any significant benefit over the open approach for the routine patient with appendicitis Background Recent developments in minimally invasive surgery have introduced scarless surgeries such as natural orifice transluminal endoscopic surgery ( NOTES ) and single-site laparoscopic surgery . Among surgical procedures , the appendectomy is one of those targeted for early adoption of new minimally invasive surgical techniques . To date , however , only a limited number of case series have been reported . Thus , the current study aim ed to evaluate the safety and feasibility of single-site laparoscopic appendectomy ( SSLA ) compared with conventional laparoscopic appendectomy ( CLA ) . Methods The study enrolled 43 patients who consecutively received laparoscopic appendectomy and divided them into SSLA and CLA groups . The clinical characteristics and short-term operative outcomes of these patients were review ed and compared . Results The 23 patients receiving SSLA did not differ from the 20 patients receiving CLA in terms of clinical characteristics including gender , age , body mass index ( BMI ) , location of appendix , and severity of inflammation . Likewise , operation times and postoperative complication rates did not differ between the two groups . Short-term operative outcomes such as visual analog pain score and hospital stay were not different . The incision was shorter for SSLA ( 22.9 ± 3.9 mm ) than for CLA ( 29.0 ± 3.0 mm ) ( p < 0.001 ) . Conclusions The results of the current study suggest that SSLA is a feasible surgical alternative to CLA with an equivalent level of safety . The data also suggest that SSLA results in better cosmetic outcomes than CLA . Data from larger research studies are necessary to confirm these results and vali date the use of SSLA over CLA BACKGROUND Laparoscopic appendectomy ( LA ) has many advantages over the classic appendectomy ( CA ) , but this method has not been accepted yet in Bosnia and Herzegovina . Therefore , we attempted controlled r and omized study in order to compare classic appendectomy with laparoscopic appendectomy and confirm eventual advantages of caring base of appendix with hem-o-lok clips regarding ordinary accepted endoloop method during laparoscopic appendectomy . METHODS In this prospect i ve study 120 patients were involved which are divided into two groups . In group 1 , 60 patients were operated with classic method , and group II was divided into two subgroups ; 30 patients were operated with laparoscopic method in which the base of appendix was cared by double endo-loop method and 30 patients were operated by plastic non-resorptive hem-o-lok clip . During this study the time duration of operation was measured , the duration of application of hem-o-lok and endo-loop , postoperative analgesia , the duration of hospitalization , intra-operative complications , anatomic position of appendix , appendicitis , and postoperative complications . RESULTS The results of the study showed that laparoscopic appendectomy is shorter in duration if compared to the classical appendectomy with statistical significance p < 0.001 ( CA 69,4 min ; LAH 36,6 min ; LAE 37,1 min ) , hospitalization is shorter p < 0.0001 ( CA 3,6 days ; LAH 2,3 days ; LAE 2,2 days ) . Quantity of given analgesics in LA is less than in CA without statistical significance between LAE and CA ( p > 0.340 ) and between LAE and LAH ( p > 0.148 ) while there is positive statistical significance between LAH and CA ( p < 0.015 ) . Precise period of cicatrization of wound of patients operated by CA was 43 ( 71.66 % ) cases , with infection of wound in 3(5 % ) cases , phlegm of wound in 2 ( 3.3 % ) cases , healing of wound per sekundam in 9 ( 15 % ) cases and ileus in one ( 1.6 % ) patient . One patient had an infection of umbilical wound in LA and the other had cellulitis of front abdominal wall . Duration of application of hem-o-lok is shorter compared to endo-loop with statistical significance p < 0.013 ( LAH 68,2 s ; LAE 176,9 s ) . CONCLUSION Time of surgery is shorter and the duration of hospitalization , amount of given analgesic is smaller , less number of postoperative complications , better cosmetic effect and advantages of application of hem-o-lok over endo-loop laparoscopic appendectomy is preferred OBJECTIVE To compare open appendectomy ( OA ) with laparoscopic appendectomy ( LA ) for length of the operation , complications , postoperative pain control , length of hospitalization , postdischarge recovery time , and hospital charges . DESIGN Prospect i ve r and omized clinical trial of patients with acute appendicitis . SETTING Tertiary care , urban teaching hospital . PATIENTS A population -based sample of patients ( aged > or = 12 years ; weight , > 49.7 kg ) admitted to a surgical teaching service with a clinical diagnosis of acute appendicitis . Patients were prospect ively r and omized to either OA or LA during a 20-month period ( from April 1 , 1994 , to December 31 , 1995 ) . Fifty-seven patients were initially enrolled in the study ; 7 did not complete the study because of a protocol violation . All remaining patients completed the study , including postdischarge follow-up . INTERVENTIONS Two ( 7.4 % ) of the 27 patients in the LA group required conversion to OA because of technical difficulties . One patient ( in the OA group ) underwent a second surgical procedure for drainage of a pelvic abscess . Three patients ( in the LA group ) required second surgical procedures . For analysis , no crossovers were allowed and all patients remained in their originally r and omized group . MAIN OUTCOME MEASURES Length of the operation , intraoperative and postoperative complications , postoperative pain control , length of hospitalization , postdischarge recovery time , and hospital charges . RESULTS Fifty patients ( 19 women and 31 men ) were examined . Twenty-seven patients underwent LA , 2 requiring conversion to an OA . Twenty-three patients underwent an OA . Patient demographics were similar between groups . Statistical differences between the 2 groups were found for ( 1 ) length of the operation ( median , 81.7 vs 66.8 minutes , LA vs OA groups : P < .002 ) , ( 2 ) operating room charges ( median , $ 3191 vs $ 1514 , LA vs OA group ; P < .001 ) , and ( 3 ) total hospital charges ( median , $ 5430 vs $ 3673 , LA vs OA group ; P < .001 ) . No statistical differences between the 2 groups were found for ( 1 ) length of hospitalization ( median , 1.1 vs 1.2 days , LA vs OA group ) , ( 2 ) pain control ( mean , 4 vs 3.7 of 10 [ 0 indicates least pain ; 10 , most pain ] , LA vs OA group ) , ( 3 ) recovery time ( time necessary before returning to work or school ) ( median , 14.0 days for both groups ) , and ( 4 ) complications ( 5 vs 1 , LA vs OA group ) . CONCLUSIONS Laparoscopic appendectomies and OAs are comparable for complications , postoperative pain control , length of hospitalization , and recovery time . Patients who underwent an OA had a shorter operative time and lower operating room and hospital charges . Laparoscopic appendectomy does not offer any proved benefits compared with the open approach for the routine patient with acute appendicitis Background / Aim : The aim of the study was to compare laparoscopic and open appendectomy ( OA ) in terms of primary outcome measures . Study design : A r and omized controlled trial . Place and duration of the study : Khyber Teaching Hospital , Peshawar , Pakistan , February 2008 to December 2009 . Patients and Methods : A total of 160 patients were divided into two groups , A and B. Group A patients were subjected to laparoscopic appendectomy ( LA ) , whereas Group B patients were subjected to OA . Data regarding age , gender , and primary outcome measures , such as hospital stay , operative duration , and postoperative complication , were recorded and analyzed . Percentages were calculated for categorical data , whereas numerical data were represented as mean ± SD . Chi-square test and t test were used to compare categorical and numerical variables , respectively . Probability ≤ 0.05 ( P ≤ 0.05 ) was considered significant . Results : After r and omization , 72 patients in group A and 75 patients in group B were analyzed . The mean age of patients in groups A and B was 23.09 ± 8.51 and 23.12 ± 10.42 years , respectively , ( P = 0.981 ) . The mean hospital stay was 1.52 ± 0.76 days in group A and 1.70 ± 1.06 days in group B ( P = 0.294 ) . The mean operative duration in group A and B were 47.54 ± 12.82 min and 31.36 ± 11.43 min , respectively ( P < 0.001 ) . Pain ( overall level ) was significantly less in group A compared with group B ( P = 0.004 ) . The two groups were comparable in terms of other postoperative complications , such as hematoma ( P = 0.87 ) , paralytic ileus ( P = 0.086 ) , urinary retention ( P = 0.504 ) , and wound infection ( P = 0.134 ) . Conclusion : LA is an equivalent procedure and not superior to OA in terms of primary outcome measures Background The role of laparoscopic treatment in acute appendicitis still is unclear . Although some evidence in the literature suggests diagnostic benefits from laparoscopy for young women with suspected acute appendicitis , there is scepticism about the utility of this approach for men . This study aim ed to compare open and laparoscopic appendectomy performed for men with suspected acute appendicitis . Methods All male patients older than 15 years with an American Society of Anesthesiology ( ASA ) classification of 3 or less , no previous abdominal surgery , and no contraindication for pneumoperitoneum were prospect ively r and omized to undergo either open appendectomy ( OA ) or laparoscopic appendectomy ( LA ) . The primary end point was a detected difference in postoperative hospital length of stay , and the secondary end points were detected differences in postoperative analgesia , morbidity , and length of the recovery period . Results In this study , 147 men with suspected acute appendicitis were r and omized to either OA ( n = 75 ) or LA ( n = 72 ) . It took longer to perform LA ( 60 min ; range , 20–120 min vs. 45 min ; range , 20–90 min ; p = 0.0027 ) , and LA did not result in any significant difference for the parameters evaluated . Conclusion The postoperative length of hospital stay did not differ significantly between OA and LA for men . Laparoscopic appendectomy required more time and did not offer any advantages compared with OA Though laparoscopic appendectomy started endoscopic surgery in general surgery , it has yet not reached the acceptance as is the case with cholecystectomy . The application of this technique in possibly bl and appendices and reports that the technique was accompanied by severe complications , increases the scepticism about it . This made us decide to start a r and omized controlled trial : laparoscopic vs. conventional appendectomy . More than 1000 endoscopic interventions mainly performed at the gallbladder and the stomach and 165 prospect ively documented and partly treated patients with acute appendicitis were the basis to start this trial . " Acute Appendicitis " was diagnosed on the basis of clinical symptoms by means of the computer-aided question naire of the EC- study " Acute Abdominal Pain " , a self-developed vali date d diagnostic score , the macroscopic findings and the careful assessment of the histology of the resected appendix . Beside the technical feasibility , principle end-points were mainly intensity and course of postoperative pain measured by means of the Visual Analogue Scale ( VAS ) in lying , st and ing and moving position and the postoperative consumption of analgesics . We assessed a difference of 15 points on the VAS as clinical ly relevant . Of 57 patients with acute appendicitis we performed open appendectomy in 23 and laparoscopy in 34 patients according to r and omization . In 9 patients of the laparoscopy group it was necessary to change over to open appendectomy for different reasons result ing in a direct comparison of 25 laparoscopies versus 23 open appendectomies . There were no differences between sociodemographic and pre clinical data in both groups . ( ABSTRACT TRUNCATED AT 250 WORDS Background The clinical outcomes for patients r and omized to either open or laparoscopic appendectomy are comparable . However , it is not known whether this is true in the subset of the adult population with higher body mass indexes ( BMI s ) . This study aim ed to compare the outcomes of open versus laparoscopic appendectomy in the obese population . Methods A subgroup analysis of a r and omized , prospect i ve , double-blind study was conducted at a county academic medical center . Of the 217 r and omized patients , 37 had a BMI of 30 kg/m2 or higher . Open surgery was performed for 14 and laparoscopic surgery for 23 of these patients . The primary outcome measures were the postoperative complication rates . The secondary outcomes were operative time , length of hospital stay , time to resumption of diet , narcotic requirements , and Medical Outcomes Survey Short Form 36 ( SF-36 ) quality -of-life data . Results No differences in complications between the open and laparoscopic groups were found . Also , no significant differences were seen in any of the secondary outcomes except for a longer operative time among the obese patients . Conclusions In this study , laparoscopic appendectomy did not show a benefit over the open approach for obese patients with appendicitis The discussion about laparoscopic appendectomy has increased since the introduction of this method . R and omized comparisons are still feasible , whereas this can not be stated for other laparoscopic procedures ( e.g. , laparoscopic cholecystectomy ) . This r and omized controlled trial included 170 patients . Open appendectomy was employed in 83 patients , and 87 were treated laparoscopically . The treatment groups were comparable regarding age , sex , Broca index , ASA classification , preliminary operations , and preoperative leucocytes . No statistically significant differences could be found with respect to surgical and general complications , operating time , consumption of analgesics and antibiotics , and return to work . The analysis revealed a statistically significant shorter hospital stay , a shorter time until return to normal physical activity , and a shorter duration of complaints for the laparoscopic group . We were unable to demonstrate any statistically significant advantage in using the open procedure AIM To compare the effect of an initial early computed tomography ( CT ) examination versus st and ard practice ( SP ) on the length of hospital stay , diagnostic accuracy , and mortality of adults presenting with acute abdominal pain . MATERIAL S AND METHODS Two hundred and five adults presenting with acute abdominal pain were r and omized to undergo an early CT examination or current SP , which comprised supine abdominal and erect chest radiography . One hundred and ninety-eight patients ( 99 in each arm ) were included in the analysis . The primary endpoint was the duration of inpatient stay ; secondary endpoints were diagnostic certainty and mortality . RESULTS There was no significant difference in the length of hospital stay between the two arms ( p=0.20 ) . At r and omization 36 % ( 35 of 96 ) of CT patients and 49 % ( 48 of 98 ) of SP patients were correctly diagnosed ; 24h after r and omization the correct diagnosis had been established in 84 % of CT patients and 73 % of SP patients . This refinement in diagnostic certainty was significantly better in the CT group ( p<0.001 ) . There was no difference in mortality between the two trial arms ( p=0.31 ) . CONCLUSION Early abdominal CT in patients with acute abdominal pain improves diagnostic certainty , but does not reduce the length of hospital stay and 6 month mortality OBJECTIVE To assess the value of laparoscopy in the accurate diagnosis of appendicitis in women of child-bearing age . DESIGN Prospect i ve r and omised trial . SETTING University hospital , Kuwait . SUBJECTS 100 patients who fulfilled the inclusion criteria between July 1988 and March 1990 . INTERVENTIONS 50 patients were r and omised to have diagnostic laparoscopy followed by appendicectomy if necessary , and the other 50 to have immediate appendicectomy . MAIN OUTCOME MEASURES Avoidance of unnecessary appendicectomy , length of operating time , and length of stay in hospital . RESULTS 19 of 50 patients in the study group did not require appendicectomy ( 38 % ) . One patient required an emergency operation for an ectopic pregnancy . Of the remaining 30 , only 4 of the removed appendixes showed no histological abnormality ( 13 % ) . There were no complications of laparoscopy . CONCLUSION Laparoscopy is a safe and effective way of diagnosing acute appendicitis and should be used more often BACKGROUND Previous r and omized studies of laparoscopic appendectomy produced conflicting recommendations , and the adequacy of sample sizes is generally unknown . We compared clinical and economic outcomes after laparoscopic and open appendectomy in a sample of predetermined statistical power . METHODS A pre- study power analysis suggested that 200 r and omized patients would yield 80 % power to show a mean decrease of 1.3 days ' hospitalization . One hundred ninety-eight patients with a preoperative diagnosis of acute appendicitis were r and omized prospect ively to laparoscopic or open appendectomy . Economic analysis included billed charges , total costs , direct costs , and indirect costs associated with treatment . RESULTS Laparoscopic appendectomy took longer to perform than open appendectomy ( median , 107 vs 91 minutes ; P < .01 ) and was associated with fewer days to return to a general diet ( mean , 1.6 versus 2.3 days ; P < .01 ) , a shorter duration of parenteral analgesia ( mean , 1.6 versus 2.2 days ; P < .01 ) , fewer morphine-equivalent milligrams of parenteral narcotic ( median , 14 mg versus 34 mg ; P = .001 ) , a shorter postoperative hospital stay ( mean , 2.6 versus 3.4 days ; P < .01 ) , and earlier return to full activity ( median , 14 versus 21 days ; P < .02 ) . However , operative morbidity and time to return to work were comparable . Billed charges and direct costs were not significantly different in the 2 groups ( $ 7711 versus $ 7146 and $ 5357 versus $ 4945 , respectively ) , but total costs ( including indirect costs ) of laparoscopic appendectomy were , on average , nearly $ 2400 less , given the shorter length of stay and abbreviated recuperative period ( $ 11,577 versus $ 13,965 ) . Subgroup analyses suggested the benefit of a laparoscopic approach for uncomplicated appendicitis and for patients with active lifestyles . CONCLUSIONS While laparoscopic appendectomy is associated with statistically significant but clinical ly question able advantages over open appendectomy , a laparoscopic approach is relatively less expensive . The estimated difference in total costs of treatment ( direct and indirect costs ) was at least $ 2000 in more than 60 % of the bootstrapped iterations . The economic significance and implication s favoring a laparoscopic approach can not be ignored Abstract Background : The aggressive surgical approach to patients suspected of having acute appendicitis for fear of perforation , and the inaccuracy of available diagnostic methods lead to an unacceptably high negative appendicectomy rate , especially in young women , in whom gynecological disorders frequently mimic appendicitis . Our objectives were to determine the value of diagnostic laparoscopy in women of child-bearing age to reduce the number of negative laparotomies and establish the correct diagnosis to allow prompt and appropriate treatment . Methods : 161 consecutive adult female patients under 50 years of age with a clinical diagnosis of acute appendicitis underwent diagnostic laparoscopy prior to the planned appendicectomy . If an inflamed appendix was found , appendicectomy was usually done through a muscle-splitting McBurney incision . Other diagnoses were treated accordingly . A normal appendix was not removed . Results were compared to a group of 42 similar patients in whom the laparoscopy was omitted for various reasons , to 23 postmenopausal women , and to all 137 male adults , directly operated by the McBurney approach . Results : After laparoscopy , 55 % of the patients required appendicectomy for appendicitis while in 23 % a gynecological diagnosis was made in spite of previous examination by a gynecologist . Fourteen percent had a negative laparoscopy . There were no false-negative results . The negative appendicectomy rate after laparoscopy was 5 % due to two false positives and eight laparoscopy failures . In the group of fertile females who escaped laparoscopy the negative appendicectomy rate was 38 % . The respective rates for postmenopausal women and men were 4 % and 8 % . Conclusions : All women of child-bearing age suspected of having acute appendicitis should undergo diagnostic laparoscopy prior to the planned appendicectomy , regardless of the certainty of the preoperative diagnosis . This is currently the only way to reduce the negative appendicectomy rate and establish a correct diagnosis allowing prompt and appropriate treatment . In male patients and postmenopausal women one may proceed directly to emergency appendicectomy Background : The comparison of laparoscopic to open appendectomy has been review ed in many retrospective and prospect i ve studies . Some report shorter hospital stays , less postoperative pain , and earlier return to work while others fail to demonstrate such differences . We performed a prospect i ve , r and omized double-blinded trial to evaluate this ongoing debate . Methods : Fifty-two consecutive men presenting with signs and symptoms suggestive of acute appendicitis were r and omized to undergo either laparoscopic appendectomy or open appendectomy . Length of operative times , hospital stay , lost work days , visual analog pain scores , and operative costs were compared . Results : Length of stay averaged 21.5 h for the laparoscopic group and was not statistically different when compared to the open group . Perceived postoperative pain on postoperative days 1 and 7 were not statistically different between the two groups . Mean time to return to work was 11 days , and there was no statistical difference between groups . Operative costs were > $ 600 greater for the laparoscopic approach . Conclusions : In this prospect i ve r and omized double-blinded trial , laparoscopic appendectomy appears to confer no significant advantage over open appendectomy for postoperative pain or lost work days . It does carry an increase in operating room costs and , contrary to other reports , hospital stay is not shortened . Further studies are needed to determine if specific population s , such as the obese or women , may benefit from a minimally invasive approach to appendicitis BACKGROUND Laparoscopic procedures are performed commonly in children . In general , the cost containment of laparoscopic surgery in children has not been evaluated . OBJECTIVE To compare the costs of laparoscopic appendectomy with those of open appendectomy . DESIGN Prospect i ve clinical trial between November 1 , 1997 , and April 30 , 2000 . For analysis , cost of supplies , operation room use , and recovery in the hospital and after discharge was evaluated . Costs common to both groups were not determined . SETTING Operations performed in a university hospital . Patients Eighty-seven children aged 4 to 15 years who underwent appendectomy for suspected appendicitis . Patients were r and omized to laparoscopic or open appendectomy . Intervention Laparoscopic appendectomies performed with the same st and ard set of reusable equipment . MAIN OUTCOME MEASURES Cost surplus of the laparoscopic procedure and recovery after surgery were evaluated , to determine the costs and effects of laparoscopic appendectomy compared with those of open appendectomy in children . RESULTS Excess operating and complication costs per procedure were 96 euros ( EUR ) in laparoscopic appendectomy . The increased operative expenses were offset by a shorter hospital stay , result ing in a marginal difference of 53 EUR in itemized total costs between the 2 procedures ( total cost , 1023 EUR in the laparoscopic appendectomy group and 970 EUR in the open appendectomy group ) . After laparoscopic appendectomy , children returned to school and sports earlier than those who had had an open appendectomy . CONCLUSION Laparoscopic appendectomy was marginally more expensive , but it allowed earlier return to normal daily activities than open appendectomy Background Whether laparoscopy offers a benefit over open surgery in the management of acute appendicitis or not remains a subject of controversy despite the publication of numerous r and omized studies . This study aim ed to compare laparoscopic appendectomy ( LA ) with open appendectomy ( OA ) and to ascertain its therapeutic benefit . Methods Adult patients older than 14 years presenting with signs and symptoms suggestive of acute appendicitis were r and omized to undergo either LA or OA from January 2006 to December 2007 . Comparisons were based on operating time , time until return to a general diet , time until return to normal activity and work , length of hospital stay , billed charges , and postoperative complications . Results The study enrolled 220 patients : 108 to undergo OA and 112 to undergo LA . The groups were similar in terms of clinicopathologic characteristics . The operating time seemed to be shorter for the OA patients than for the LA patients , but the difference was not significant ( LA , 30 ± 15.2 min vs. OA , 28.7 ± 16.3 min ; p > 0.05 ) . The hospital stay of 4.1 ± 1.5 days for the LA group and 7.2 ± 1.7 days for the OA group , and the difference was statistically significant ( p < 0.05 ) . Laparoscopic appendectomy remained associated with a shorter time until return to a general diet ( LA , 20.2 ± 12.4 h vs. OA , 36.5 ± 10 h ; p < 0.05 ) , to normal activity ( LA , 9.1 ± 4.2 days vs. OA , 13.7 ± 5.8 days ; p < 0.05 ) , and to work ( LA , 21.2 ± 3.5 days vs. OA , 27.7 ± 4.9 days ; p < 0.05 ) . The billed charges appeared to be higher for LA ( LA , 5,720.3 ± 115.7 yuan vs. OA , 5,310 ± 575.4 yuan ) , but this difference failed to be clinical ly important or statistically significant ( p > 0.05 ) . Wound infections were more common after OA ( n = 14 ) than after LA ( n = 0 ) ( p < 0.05 ) . Intraabdominal abscesses occurred for two patients in the LA group and nine patients in the OA group ( p < 0.05 ) . Postoperative ileus occurred with frequencies of 0 % in the LA group and 7.4 % in the OA group ( p < 0.05 ) . The rate for overall complications was significantly lower in the LA group . Conclusion Laparoscopic appendectomy is a useful tool in the treatment of acute appendicitis . Its advantages lie in its minimal invasiveness , its better cosmetic outcome , its lower rate of complications based on surgical expertise and state-of-the-art equipment . It can be recommended as an adoptable method for the routine patient with appendicitis Abstract Background : Diagnostic laparoscopy plays a significant role in the evaluation of acute and chronic abdominal pain in the era of therapeutic laparoscopic surgery . Methods : We referred to our personal series of laparoscopy for both acute and chronic abdominal pain . This is a retrospective review of data accumulated prospect ively between 1979 and the present . Results : In our series , 387 consecutive patients underwent laparoscopy because of abdominal pain . In a group of 121 patients with acute abdominal pain , a definitive diagnosis was made in 119 cases ( 98 % ) . Two patients needed laparotomy to confirm the diagnosis ; both had a disease process that did not require laparotomy to treat . A definitive therapeutic laparoscopic procedure was performed in 53 cases 944 % ) . In 45 patients ( 38 % ) , a diagnosis was made that did not require therapeutic laparoscopy or laparotomy to treat . In the remaining 21 patients ( 17.5 % ) , exploratory laparotomy was needed to treat the condition . In a chronic abdominal pain group of 265 patients , the etiology was established laparoscopically in 201 cases ( 76 % ) . A definitive therapeutic laparoscopic procedure was performed in 128 patients ( 48 % ) . There was a normal laparoscopic examination in 64 patients ( 24 % ) . There was one false negative laparoscopy that required laparotomy to treat 1 month later . Conclusions : Laparoscopy is an accurate modality for the diagnosis of both acute and chronic abdominal pain syndromes . These data support the use of laparoscopy as the primary invasive intervention in patients with acute and chronic abdominal pain BACKGROUND / PURPOSE Laparoscopic Appendectomy ( LA ) is a safe procedure in adults result ing in shorter hospitalization and sooner return to activity . The relative merits of LA and open appendectomy ( OA ) are evaluated in this first prospect i ve and r and omized study in children . METHODS A total of 129 children with appendicitis were included . Forty-three boys and 45 girls , age 1 to 16 years , were enrolled . R and omization was determined by sealed assignment card . OA utilized a 3- to 4-cm right lower quadrant , muscle-splitting incision . Wounds were closed without drains . Antibiotics , when used , consisted of gentamycin , clindamycin , and ampicillin . LA was performed by experienced surgeons utilizing a 3-trocar technique with reusable instruments . Twenty-one children ( 24 % ) were perforated . Patients were discharged as soon as they were taking a diet and afebrile . Statistical comparisons were by Fisher 's Exact and Wilcoxon rank-sum tests . RESULTS There were no differences in postoperative analgesia , resumption of oral intake , length of hospitalization , return to normal activities , or morbidity . Laparoscopic appendectomy was associated with longer operating times and increased cost . CONCLUSIONS Laparoscopic appendectomy in children is not associated with the same advantages reported in adults . LA is a more expensive alternative and offers no advantages related to pain relief , length of stay , return to normal activities , or morbidity The objective of the study was to compare the efficacy of azithromycin , alone or with metronidazole , versus two st and ard multidrug regimens for the treatment of acute pelvic inflammatory disease ( PID ) . Patients with PID were treated with once-daily intravenous ( IV ) azithromycin 500 mg for 1 day or 2 days followed by once-daily azithromycin 250 mg orally for a total of 7 days , alone or with three-times-daily metronidazole 400 mg or 500 mg IV then orally for a total of 12–14 days . The comparators were either metronidazole + doxycycline + cefoxitin + probenecid or doxycycline + amoxycillin/clavulanate given at st and ard recommended doses for up to 21 days . In total , 309 patients were treated for PID . The diagnosis was confirmed laparoscopically in 74.8 % of patients . Rates of clinical success for azithromycin , alone ( 97.1 % ) or with metronidazole ( 98.1 % ) , were comparable to those for the comparator regimens ( 94.6 % ) . Eradication rates for Chlamydia trachomatis , Neisseria gonorrhoeae , Mycoplasma hominis and anaerobes were also comparable for each of the treatment groups . Both azithromycin regimens were well tolerated . In conclusion , azithromycin , alone or with metronidazole , provides a shorter , simpler treatment option for the successful management of acute PID Abstract . A prospect i ve r and omized trial comparing laparoscopic appendectomy with open appendectomy in patients with a diagnosis of acute appendicitis was conducted between October 1992 and April 1994 . Of the 158 patients r and omized , 7 patients were excluded because of protocol violations ( conversion to laparotomy in 4 , appendix not removed in 3 ) . The 151 patients r and omized to either a laparoscopic ( n = 79 ) or an open appendectomy ( n = 72 ) showed no difference in sex , age , American Society of Anesthesiology ( ASA ) rating , or previous abdominal surgery . The histologic classification of normal , catarrhal , inflamed , suppurative , and gangrenous appendicitis was not different between the two groups . Conversion from laparoscopic to open appendectomy was necessary in seven patients ( 9 % ) who had advanced forms of appendiceal inflammation . When compared to open appendectomy the laparoscopic group had a longer median operating time ( 63 minutes versus 40 minutes ) , fewer wound infections ( 2 % versus 11 % ) , less requirement for narcotic analgesia , and an earlier return to normal activity ( median 7 days versus 14 days ) . There was no difference in morbidity , and both groups had a median time to discharge of 3 days . Laparoscopic appendectomy is as safe as open appendectomy ; and despite the longer operating time , the advantages such as fewer wound infections and earlier return to normal activity make it a worthwhile alternative for patients with a clinical diagnosis of acute appendicitis Abstract Background and objectives : The study aim ed to evaluate the utility of a laparoscopic approach in the management of patients with right lower abdominal pain and in the quality of life after the operation . Methods : Patients with suspected appendicitis were included in the study . They were r and omly assigned either to treatment with a traditional open approach or with a laparoscopic approach . The patients ’ data , including demographic data , complications and gastro-intestinal quality of life index scores , were collected at the 6th week and 6th month and compared between the groups . Results : Overall , 83 appendectomies were performed . Other pathologies were ovulation bleeding , ovarian cyst , Meckel ’s diverticulum , ectopic pregnancy and leiomyoma of the uterus . Negative appendectomy rate was 7 % . Severe infection occurred in five of the open group . The advantages of the laparoscopy also showed significantly in hospital stay ( 55.80 ± 20.97 hours vs. 75.06 ± 35.14 hours ) , the need for narcotics and in visual analog score , as well as in the gastrointestinal quality of life index ( 85.88 ± 9.73vs101.30 ± 9.31 ) . The quality of life is still better in the long-term ( 95.14 ± 8.45 vs120.36 ± 10.25 ) . When the groups were compared according to the subgroups of gastro-intestinal quality of life index , except for disease-specific items , in all categories a significant improvement was seen in the laparoscopically treated patients . This improvement was observed in the follow-up period also . However , the hospital costs ( 987.50 ± 77.25 USD vs. 406.27 ± 100.59 USD ) and operative time ( 56.25 ± 10.9 vs. 49.41 ± 11.76 minutes ) still continued to be a problem for the laparoscopic group . Conclusion : Laparoscopic appendectomy is a safe method , which also has advantages of diagnostic procedure for other pathologies , a better quality of life both in the early and late period , and a short hospital stay . The important advantage is also seen in the late period with better quality of life Objective The authors determined whether there was an advantage to laparoscopic appendectomy when compared with open appendectomy . Summary / Background Data The advantages of laparoscopic appendectomy versus open appendectomy were question ed because the recovery from open appendectomy is brief . Methods From January 15 , 1992 through January 15 , 1993 , 75 patients older than 9 years were entered into a study r and omizing the choice of operation to either the open or the laparoscopic technique . Statistical comparisons were performed using the Wilcoxon test . Results Thirty-seven patients were assigned to the open appendectomy group and 38 patients were assigned to the laparoscopic appendectomy group . Two patients were converted intraoperatively from laparoscopic appendectomies to open procedures . Thirty-one patients ( 81 % ) in the open group had acute appendicitis , as did 32 patients ( 84 % ) in the laparoscopic group . Mean duration of surgery was 65 minutes for open appendectomy and 87 minutes for laparoscopic appendectomy ( p < 0.001 ) . There were no statistically significant differences in length of hospilalization , interval until resumption of a regular diet , or morbidity . Duration of both parenteral and oral analgesic use favored laparoscopic appendectomy ( 2.0 days versus 1.2 days , and 8.0 days versus 5.4 days , p < 0.05 ) . All patients were instructed to return to full activities by 2 weeks postoperatively . This occurred at an average of 25 days for the open appendectomy group versus 14 days for the laparoscopic appendectomy group ( p < 0.001 ) . Conclusions Patients who underwent laparoscopic appendectomies have a shorter duration of analgesic use and return to full activities sooner postoperatively when compared with patients who underwent open appendectomies . The authors consider laparoscopic appendectomy to be the procedure of choice in patients with acute appendicitis OBJECTIVE To evaluate the efficacy of diagnostic laparoscopy in patients with suspected acute appendicitis , the number of complications associated with the laparoscopic technique , and the effect of leaving a macroscopically normal-looking appendix in place . DESIGN Three prospect i ve protocol s. SETTING Three departments of surgery , one in Norway and two in Sweden . SUBJECTS 1043 patients aged 15 years or over . INTERVENTIONS Diagnostic laparoscopy in patients with signs and symptoms of acute appendicitis who were to be operated on . MAIN OUTCOME MEASURES Morbidity , mortality , and histological appearance of removed appendices , and outcome whether or not the patient was operated on . RESULTS 819 patients had appendectomies ( 61 % laparoscopically and 39 % by conversion to open operation ) with a total complication rate of 10 % . In 211 patients a diagnostic laparoscopy was done as a single procedure . There were 181 women in this group and 86 of them had gynaecological disorders . The complication rate was 2 % among these 211 patients and after a follow up of two years no patients had been readmitted for appendicectomy . 13 patients were subjected to other open procedures . The overall mortality was 0.4 % . CONCLUSION Diagnostic laparoscopy is safe and can be recommended in patients with suspected acute appendicitis , particularly in women . A macroscopically normal-looking appendix can be left in place In a series of 187 patients with acute abdominal pain syndrome , 65 young women reported non specific pain in right iliac or pelvic area . A controlled study compared 33 patients with immediate laparoscopy and 32 explored with a laboratory contrast or imaging approach . In the laparoscopic group , an exact diagnosis was made in 97 % of the patients , allowing in 2/3 of cases the endoscopic treatment . Only 28 % in the second group had an exact diagnosis . Hospital stay was shorter in the laparoscopic group ( 4.18 vs 6.16 days ; p = 0.01 ) decreasing the hospital cost . The authors suggest that immediate laparoscopy should be performed in young women presenting with non-specific abdominal pain OBJECTIVES To assess the utility of laparoscopic versus conventional surgical exploration in premenopausal women with suspected acute appendicitis . METHOD Female patients aged 15 - 45 years in whom an independent decision to undertake surgical exploration had been made , were r and omised to laparoscopic or open procedures . Comparison of patient groups was conducted on an intention-to-treat basis . RESULTS Eighteen patients underwent laparoscopic exploration , with 1 procedure requiring conversion to lower midline laparotomy . Open surgical exploration was performed primarily in 16 patients . Postoperative complications ( 3 patients versus 1 patient ) and diagnostic errors ( 5 patients versus 1 patient ) were more frequent in patients undergoing open surgical procedures . Laparoscopic procedures tended to be of longer duration than open operations , but were generally associated with slightly more favourable indices of postoperative recovery ( analgesic requirement , postoperative hospitalisation , return to normal activity , return to work ) . In patients found not to have acute appendicitis , the difference in mean postoperative hospitalisation following laparoscopic intervention ( 2.6 days ) and conventional surgery ( 3.4 days ) approached statistical significance ( p < 0.1 ) . CONCLUSIONS Laparoscopy may carry some diagnostic advantage over open surgery in premenopausal women with suspected acute appendicitis . Patients found not to have acute appendicitis have a marginally shorter period of hospitalisation after laparoscopic intervention . The outcome following laparoscopic appendicectomy for confirmed acute appendicitis is at least equivalent to that achieved with conventional appendicectomy . Laparoscopic exploration is an acceptable option in premonopausal women requiring surgery for suspected acute appendicitis OBJECTIVE To compare the results of open with laparoscopic appendectomy in terms of postoperative pain , rate of wound infection and hospital stay . METHODS This quasi-experimental study was conducted in Deprtment of Surgery , Ziauddin University Hospital , Karachi , over a period of six months . Patients undergoing surgery for acute appendicitis were r and omly assigned into one of the two groups ( A or B ) after obtaining written and informed consent . In Group-A patients underwent open appendectomy and in Group B laparoscopic appendectomy was performed . Post operatively pain chart and wound infection was recorded and , at the time of discharge , number of days in hospital was calculated . RESULT Sixty patients ( 38 male , 22 female ) , with clinical diagnosis of acute appendicitis based on Alvarado score of six and above , were included in the study . They were r and omized into 2 groups of A and B with 30 patients in each group . Group-A comprised open appendectomy procedure and Group-B comprised laparoscopic appendectomy . Mean comparison of postoperative pain by visual analogue scale , was significantly low in Group B , compared with Group A , on day 0 , 1 and 2 . Number of days in Hospital was 4.1 + /- 0.8 days in Group A and 1.5 + /- 0.06 days in Group B. None of the patients in Group B , while 8 ( 26.67 % ) patients in-Group A , developed postoperative wound infection at 1 week follow up . CONCLUSION Laparoscopic appendectomy is safe and effective . Wound infection and postoperative pain is significantly lower after this mode of 43 children between the ages of 7 and 15 years with clinical symptoms of acute appendicitis were r and omised to an open appendectomy ( OA ) or a laparoscopic appendectomy ( LA ) . There were 15 acute cases of appendicitis and 5 perforated appendices in the OA group and 17 acute appendicitis , 3 cases of perforated appendices and 3 other diagnoses in the LA group . The operative time was a little shorter in the OA group . There were no differences in hospital stay or the postoperative course of the patients . In the LA group , there were two minor complications , no other complications were seen . When comparing the two surgical methods in the consistent group of patients with non-perforated acute appendicitis no statistical differences were seen in the operative time , hospital stay or in the recovery of the patients between the OA and the LA groups . We conclude that LA has no significant benefit over OA in routine use . In paediatric patients we recommend an open approach for clinical ly typical acute appendicitis , but there should be no hesitation to choose laparoscopic approach when the clinical diagnosis is unclear To study comparative results between laparoscopic and open appendectomy , all the patients with suspected acute appendicitis who presented between January 1992 and December 1994 ( N = 210 ) were r and omized into two groups : laparoscopic ( LA , n = 106 ) and open appendectomy ( OA , n = 104 ) . Patient demographics , pathological findings , operative time , postoperative course , and cost were analyzed . Age , gender , previous laparotomy , intraoperative diagnosis , and perforated appendix rate were comparable between both groups . Mean operative time was longer in the LA group ( p < 0.05 ) . Earlier resumption of a regular diet , shorter postoperative stay , and less postoperative analgesia also were observed in the LA group ( p < 0.05 ) . Postoperative morbidity and hospital readmissions were similar in both groups ( p > 0.05 ) . Higher operative cost was observed in the LA group , but global cost was lower in this group ( p < 0.05 ) . Laparoscopic appendectomy shows a more comfortable postoperative course ( oral resumption , postoperative stay , and analgesia ) over open appendectomy , with similar postoperative morbidity . The LA group showed more operative but less global cost Aims : To evaluate , in a prospect i ve , r and omized , single-institution trial , the role of early laparoscopy in the management of nonspecific abdominal pain ( NSAP ) in young women . Patients and Methods : Women aging from 13 to 45 years , admitted for NSAP at the emergency department , were included in the study . Exclusion criteria were pregnancy , previous appendectomy , contraindications to laparoscopy , diagnosis of malignancy , or chronic disease . NSAP was defined as an abdominal pain in right iliac or hypogastric area lasting more than 6 hours and less than 8 days , without fever , leukocytosis , or obvious peritoneal signs and uncertain diagnosis after physical examination and baseline investigations including abdominal sonography . Patients were r and omly assigned to early ( < 12 hours from admission ) laparoscopy group ( LAP ) or to clinical observation group ( OBS ) . After discharge a follow-up was carried out . Results : From January 2001 to February 2004 , 508 female patients without previous abdominal surgery were evaluated in admitting area for acute right iliac or hypogastric abdominal pain , in 373 patients diagnosis was established for obvious signs or with baseline investigations . Of the remaining 135 patients , 31 were excluded from study for various reasons , 53 patients were r and omly assigned to LAP and 51 to OBS . Groups were similar for age , mean BMI , white blood cell count , and duration of pain . During hospitalization diagnosis was established in 83.4 % of the LAP and in 45.1 % of OBS ( P < 0.05 ) . Twenty patients of OBS ( 39.2 % ) were operated during observation because of worsening of symptoms or appearance of peritoneal sign . Diagnoses in LAP were appendicitis in 16 patients ( 30.1 % ) , pelvic inflammatory disease in 7 ( 13.2 % ) , carcinoid in 1 ( 1.9 % ) , other in 18 ( 33.9 % ) , no diagnosis in 11 ( 20.7 % ) ; diagnoses in OBS were appendicitis in 3 patients ( 5.8 % ) , pelvic inflammatory disease in 8 ( 15.6 % ) , other in 12 ( 23.5 % ) , and no diagnosis in 28 ( 54.9 % ) . Mean length of hospital stay was 3.7 ± 0.8 days in LAP and 4.7 ± 2.4 days in OBS ( P < 0.05 ) ; no differences were found regarding mortality , morbidity , radiation dose , and analgesia . Mean follow-up time was 29.3 months ( range , 12–60 months ) for LAP and 30.6 months for OBS ( range , 12–60 months ) . After 3 months from discharge , 20 % of patients in LAP and 52 % in OBS had recurrent abdominal pain ( P < 0.05 ) ; after 12 months , 16 % in LAP and 25 % in OBS ( P = not significant ) . Six patients in OBS required readmission for surgery . Conclusions : Compared with active clinical observation , early laparoscopy did not show a clear benefit in women with NSAP . A higher number of diagnosis and a shorter hospital stay in the LAP group did not led to a significant reduction in symptoms recurrences at 1 year AIMS OF THE STUDY The authors present an accurate and comprehensive snapshot of appendicitis in the last decade of the 20 ( th ) century . The present study also aims to determine the influence of introduction of laparoscopic techniques on the quality of appendicitis therapy . PATIENTS AND METHODS All consecutive patients admitted for suspected appendicitis were recruited into this prospect i ve multicenter study . Two different periods of time were considered : from 1 . 7 . 1988 to 31 . 12 . 1989 , 6 266 patients from 18 hospitals were included , and from 1 . 6 . 1996 to 31 . 5 . 1997 , 7 398 patients from 34 institutions . RESULTS In the first period ( 1988/89 ) , 1 869 patients were treated conservatively ( 29.8 % ) , 4 397 ( 70.2 % ) were operated . Histopathological analysis of the appendix documented no acute inflammation in 28.8 % , the perforation rate was 8.3 % and the wound infection rate 9.6 % . In the second period ( 1996/97 ) , 2 430 patients were treated conservatively ( 32.8 % ) , in 24.9 % of all operated cases , the histopathological examination shows no acute inflammation of the appendix , the perforation rate was 5.9 % and the rate of wound infections 2.5 % . During this second period , 33.2 % of all appendectomies were performed using the laparoscope , the conversion rate was 7.2 % . CONCLUSIONS The introduction of laparoscopic techniques did not modify the operative indications for treatment of appendicitis . An increase in the number of normal appendices removed was not observed . The number of perforations and the incidence of wound infections was significantly reduced in the second period R and omised assessment of new laparoscopic surgical techniques is difficult . Surgeons need time to become experienced with the methods and tend , when they have experience , to favour one or other approach . We have carried out a prospect i ve r and omised comparison of laparoscopic and conventional appendicectomy done by surgeons of comparable experience in patients with suspected acute appendicitis . Postoperative management decisions were made by surgeons other than the operating surgeon . 140 patients were r and omly assigned to open ( OA ) or laparoscopic ( LA ) appendicectomy ( 70 each ) . The age , sex ratio , duration of symptoms , and proportion of patients with histologically confirmed appendicitis was similar in the two groups . Operating time was longer for LA than for OA ( mean 70.3 [ SD 21.9 ] vs 46.5 [ 25.9 ] min ; p < 0.001 ) . There were no major intraoperative complications in either group . 14 ( 20 % ) patients in the LA group required conversion to an open operation . No significant differences between the groups were found postoperatively for pain score , analgesic requirement , time to re introduction of diet , or hospital stay . 46 LA patients and 42 OA patients attended follow-up 3 weeks after surgery . Similar proportions had returned to work ( 36 [ 79 % ] vs 31 [ 74 % ] ) . The frequency of wound complications and wound pain after leaving hospital was lower after LA but not significantly so . We conclude that the postoperative course after LA and conventional OA does not differ significantly OBJECTIVE To compare the direct and indirect costs of laparoscopic and open appendicectomy . DESIGN R and omised study . SETTING University hospital , Sweden . MAIN OUTCOME MEASURES Total costs for a defined period of time for each option . RESULTS 102 patients were r and omised and 99 were included in the final analysis . All patients had completely recovered within two months of operation . Disposable extra material used for the laparoscopic operation and longer operating time raised its median cost by SEK 912 and 1785 , respectively . The mean duration of hospital stay , period off work ( indirect costs ) , and time to complete recovery did not differ between the groups . CONCLUSION Laparoscopic appendicectomy has higher direct costs than open operation and is not as cost-effective when the longterm outcome is the same in both groups BACKGROUND / AIMS Acute abdomen accounts for 13 - 40 % of all emergency surgical admissions . The aim of this prospect i ve r and omized controlled study was to examine the role of early laparoscopy in the management of acute abdomen compared with the more traditional active observation . METHODOLOGY From July 1993 to August 2004 , 522 patients consecutively , admitted with " acute abdomen " , were r and omized to either early laparoscopy ( 260 patients ) ( group 1 ) or active observation and non-invasive investigation ( 262 patients ) ( group 2 ) . Baseline investigations included a full blood count , a pregnancy test in women of reproductive age , chest and /or abdominal radiograph if indicated clinical ly . RESULTS Sixty-two patients in the laparoscopy group underwent a total of 116 radiological investigations compared with a total of 558 investigations in all patients in the observation group ( P < 0.05 ) . In the observation group 34.7 % of patients remained without a clear diagnosis compared with 4.2 % of patients in the early laparoscopic group ( P < 0.0001 ) . The morbidity rate was 1.1 % in group 1 and 27 % in group 2 ( P < 0.0001 ) . The duration of hospital stay was significantly shorter in group 1 ( 3.1 vs. 7.3 days ) ( P < 0.01 ) . Eight patients in group 1 required readmission ( total readmission 46 days ) compared with 58 patients in group 2 who stayed a total of 201 days ( P < 0.05 ) . CONCLUSIONS Early laparoscopy is valuable in the management of acute abdomen . It provides a significantly higher diagnostic accuracy and a better improvement in quality of life than the more traditional approach observation Background : Laparoscopic appendectomy through a single umbilical incision is an emerging approach supported by several case series . However , to date , prospect i ve comparative data are lacking . Therefore , we conducted a prospect i ve , r and omized trial comparing single site umbilical laparoscopic appendectomy to 3-port laparoscopic appendectomy . Methods : After Internal Review Board approval , patients were r and omized to laparoscopic appendectomy via a single umbilical incision or st and ard 3-port access . The primary outcome variable was postoperative wound infection . Using a power of 0.9 and an alpha of 0.05 , 180 patients were calculated for each arm . Patients with perforated appendicitis were excluded . The technique of ligation/division of the appendix and mesoappendix was left to the surgeon 's discretion . There were 7 participating surgeons dictated by the call schedule . All patients received the same preoperative antibiotics and postoperative management was controlled . Results : There were 360 patients were enrolled between August 2009 and November 2010 . There were no differences in patient characteristics at presentation . There was no difference in wound infection rate , time to regular diet , length of hospitalization , or time to return to full activity . Operative time , doses of narcotics , surgical difficultly and hospital charges were greater with the single site approach . Also , the mean operative time was 5 minutes longer for the single site group . Conclusion : The single site umbilical laparoscopic approach to appendectomy produces longer operative times result ing in greater charges . However , these small differences are likely of marginal clinical relevance . The study was registered with clinical trials.gov at the inception of enrollment ( NCT00981136 ) A study was carried out of 137 patients with a diagnosis of acute appendicitis who were r and omized to either laparoscopic or open appendicectomy . Patients found to have perforated or normal appendices at histological examination were excluded . Fifty‐two patients undergoing laparoscopic appendicectomy and those receiving 57 open procedures were analysed . Laparoscopic appendicectomy took no longer than the open procedure ( mean 43 versus 40 min ) . The number of doses of pethidine ( 1 mg per kg body‐weight ) required in the immediate postoperative period did not differ between the two groups but the mean number of doses of oral analgesic ( naproxen sodium 550 mg twice daily ) required was less in patients undergoing laparoscopic appendicectomy ( 2·8 versus 5·0 , P < 0·05 ) . There was no significant difference between time to resumption of fluid and diet intake and length of hospital stay . There were five ( 9 per cent ) wound infections after open appendicectomy compared with none after the laparoscopic operation ( P < 0·01 ) . Patients who underwent laparoscopy returned to full home ( 17 versus 30 days , P < 0·01 ) and social ( 19 versus 32 days , P < 0·05 ) activities earlier than those who underwent open operation . Laparoscopic appendicectomy may allow reduction in the number of wound infections and earlier return to normal activities OBJECTIVE Appendectomy can be performed using either a laparoscopic technique ( LT ) or an open technique ( OT ) . We compared the following items operative , anesthesia , length of stay , post-operative pain , medicine , wound healing , days to return to normal activity in both groups . METHODS This study was carried out at King Fahad Hospital , Hofuf , Al-Hassa , Kingdom of Saudi Arabia , from January 1999 to April 2000 . We r and omly assigned 60 female patients to appendectomy by LT or OT . The 2 groups were compared concerning demographic data . The differences were considered statistically significant at a P value < 0.05 . RESULTS The open group had shorter anesthesia and operative time ( 68 , 50 versus 85 , 65 minutes ) . The laparoscopic group had a significant reduced postoperative narcotic requirement ( P<0.05 ) , quicker re introduction of diet and quicker return to normal activity . CONCLUSION Laparoscopic appendectomy in female patients with clinical diagnosis of appendicitis is the procedure of choice for the diagnosis and the management of acute appendicitis OBJECTIVE The authors compare the risk of bacteraemia in open and laparoscopic appendectomy in a prospect i ve r and omized study . METHODS 35 patients with a presumptive diagnosis of acute appendicitis were r and omized to have conventional open or laparoscopic surgical procedures . Before r and omization , patients signed a consent form to participate in the study . Patients who were converted from laparoscopic to open appendectomy ( 3 cases ) , HIV+ , allergic to Augmentin or who had contraindications to laparoscopic surgery were excluded from the study . A total of 32 patients were r and omized : 17 to open ( group I ) and 15 to laparoscopic surgery ( group II ) . There were no significant differences with regard to age , ASA score , symptoms or macroscopic aspect of the appendix . Two patients had a normal appendix , 12 had acute appendicitis , 14 gangrenous appendicitis and 4 ruptured or abscessed appendicitis . All patients received preoperative antibiotic prophylaxis ( Augmentin ) after blood cultures ( H1 ) were drawn . Five other blood cultures were performed in st and ard medium and medium neutralizing Augmentin : at the time of opening the peritoneum ( H2 ) , after appendectomy ( H3 ) , after closure of the abdomen ( H4 ) , and at 6 ( H5 ) and 12 hours ( H6 ) after the operation . Bacterial cultures from the appendix site were performed before ( P1 ) and after ( P2 ) appendectomy . RESULTS The operative mortality rate after conventional or laparoscopic appendectomy was nil . The incidence of post-operative morbidity was 4 cases in group I and 2 cases in group II . No positive bacterial culture was obtained in 17 patients . The distribution of these patients was similar in groups I and II . Sample s P1 and P2 were positive in 5 cases . Nine of 27 cases with negative P1 became positive in P2 ( 33 % ) . There was no significant difference between the two groups with regard to the appearance of the appendix . Only two patients had positive blood cultures at H1 . One of them had blood cultures at H3 , H4 positive for a second germ . CONCLUSION A low risk of bacteraemia exists for both open and laparoscopic appendectomy . This risk did not appear to increase for laparoscopy . Conventional and laparoscopic surgical procedures led to positive peritoneal bacterial cultures after appendectomy in 33 % of cases A prospect i ve r and omized multicentre study was performed to compare the outcome of laparoscopic and open appendicectomy in patients with suspected acute appendicitis Two groups of 30 women with clinical signs of appendicitis were r and omized to immediate appendicectomy or diagnostic laparoscopy . In the latter group , appendicectomy was performed if a diagnosis of acute appendicitis was established or if the appendix could not be visualized . Eleven patients undergoing immediate operation had unnecessary appendicectomy , compared with two having laparoscopy . This difference of 30 per cent ( 95 per cent confidence interval 11–49 per cent ) was significant ( P = 0.01 ) . There was no significant difference in postoperative morbidity rate in the two groups . Diagnostic laparoscopy is a useful preliminary investigation in women with clinical signs of acute appendicitis Although classic open surgery is simple , expeditious , and effective , it has some drawbacks , including wound sepsis , delayed recovery , operative difficulties , and possibility of unnecessary appendectomies for false appendicitis . The aim of this study was to assess the applicability and safety of laparoscopic appendectomy ( LA ) in a prospect ively r and omized trial . Seventy nonselective patients with suspected appendicitis were r and omized to laparoscopic ( n = 35 , 17 male ) or open appendectomy ( n = 35 , 15 male ) and operated on an emergency basis . Operative findings , operating time , postoperative complications , and length of hospital stay were compared . We found that LA is associated with a shorter hospital stay , fewer postoperative complications , and better diagnostic accuracy , and it is recommended as the procedure of choice for the diagnosis and management of acute appendicitis To evaluate whether laparoscopic appendectomy shortens the convalescence and the postoperative period until return to work when compared to conventional appendectomy , a prospect i ve r and omized trial was performed . The major endpoint of the study was the time until return to work ; minor endpoints were postoperative pain , fatigue , operative time and postoperative morbidity . In all , 54 patients with a mean age of 29.5 + /- 10.1 years were r and omized to open ( n = 28 ) or laparoscopic appendectomy ( n = 26 ) . Age , sex , body mass index ( BMI ) , American Society of Anesthesiology ( ASA ) rating , job status as well as histologic degree of inflammation of the appendix were comparable in the two groups . Operative time was 59.2 + /- 15.8 min for laparoscopic and 59.8 + /- 24.4 min for conventional appendectomy ( P = 0.9 ) . Some 16 laparoscopic appendectomies ( 62 % ) were performed by board-certified surgeons , while 23 conventional appendectomies ( 82 % ) were performed by residents ( P = 0.003 ) . Postoperative morbidity was comparable between the two groups . After laparoscopic appendectomy , pain was rated significantly lower on the first , second and fourth postoperative day when compared to the conventional group . There were no difference in postoperative fatigue between the groups . Time to return to work was 17.0 + /- 6.2 days in the laparoscopic group and 18.2 + /- 6.0 days in the conventional group ( p = 0.5 ) . Laparoscopic appendectomy has no advantages in terms of convalescence and time to return to work when compared to open appendectomy and should therefore be limited to selected cases OBJECTIVES To compare the accuracy of laparoscopy performed within 24 h of admission and the conventional method based on clinical observation in the etiological diagnosis of non-specific acute lower abdominal pain ( NSLAP ) in women of reproductive age . METHODS A total of 110 patients who met the selection criteria and were seen from November 1997 to June 2000 at the Instituto Materno Infantil , a referral hospital for maternal and perinatal care in Bogotá , were r and omly divided into two groups . The effectiveness of each method was evaluated according to number of diagnoses reached , length of in-patient stay before diagnosis , complications , and diagnostic accuracy when compared with a st and ard given by microbiological and histopathological findings as well as clinical course . RESULTS The early laparoscopy group did not experience more accurate diagnoses ( 85 % vs. 79 % , P=0.61 ) or a greater number of complications ( 11 % vs. 9 % , P=0.48 ) , although the patients ' stay was shorter ( 1.3 vs. 2.3 days , P=0.008 ) than the stay of the conventional-diagnosis group . Sensitivity analysis showed more accurate judgements with laparoscopy in four of the five NSLAP causes , but only in two of the cases did this greater accuracy have clinical significance . CONCLUSIONS Early laparoscopy did not show a clear benefit in women with NSLAP Abdominal pain of uncertain aetiology ( non‐specific abdominal pain ; NSAP ) is the commonest reason for emergency surgical admission . The aim of this study was to examine the role of early laparoscopy in the management of NSAP This prospect i ve clinical study was done because our initial retrospective review suggested that laparoscopic appendectomy ( LA ) offers no significant advantages over open appendectomy ( OA ) yet is significantly more expensive . From July 1992 to August 1993 , 57 patients were approached preoperatively for r and omization to either LA ( n=19 ) or OA ( n=18 ) . There were no statistically significant differences between the LA and OA groups in operative risk : mean age , 28 ± 2 vs 26 ± 2 years ; percent female , 26 % vs 22 % ; body mass index , 24 ± 0.8 vs 26 ± 1.2 kg/m2 . All patients were either ASA class I or class II , 78 % in each group being class II . The differences between the LA and OA groups in mean operating time required ( 93 ± 12 vs 87 ± 8 minutes ) , postoperative intramuscular narcotic analgesic usage ( 24 ± 6 vs 26 ± 6 hours ) , postoperative hospital stay ( 57 ± 12 vs 66 ± 10 hours ) , and return to normal activity ( 20 ± 6 vs 14 ± 3 days ) were also not significant . However , LA was much more expensive because of higher operating room charges . The mean total hospital bill was $ 4,600 ± $ 160 for the LA group and $ 1,700 ± $ 70 for the OA group . This prospect i ve study corroborated our previous analysis . Laparoscopic appendectomy is safe , effective , and expensive and overall has no greatly significant advantages over open appendectomy |
1,372 | 26,687,683 | Colchicine is an effective treatment in FMF | Abstract Familial Mediterranean fever ( FMF ) is an autoinflammatory disease , which can be well controlled with lifelong use of colchicine .
Since studies dealing with the efficacy and safety of colchicine were conducted mainly in the sixties and seventies of the previous century , it seems that this topic needs to be up date d. Recently , an international expert panel was undertaken for the establishment of recommendations on how to manage FMF .
We aim ed to summarize the efficacy and safety of the current treatments available to prevent FMF attacks and to avert the appearance of amyloidosis secondary to FMF . | Abstract A four-month , double-blind , crossover study of 22 patients with familial Mediterranean fever was undertaken to study the effect of colchicine in decreasing acute attacks of that disease . T Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results BACKGROUND About a quarter of familial Mediterranean fever ( FMF ) patients are partially or totally resistant to colchicine . A previous observation reported that acute attacks may be shortened by administration of interferon alpha ( IFN ) . OBJECTIVE We design ed a double-blind , placebo-controlled trial to test our initial observations of a beneficial response with IFN in FMF attacks . METHODS We treated 34 acute abdominal attacks with IFN 5 million IU or placebo sc in the early phase of the attack . Leucocytes , thrombocytes , the erythrocyte sedimentation rate , fibrinogen , C-reactive protein ( CRP ) , serum amyloid A protein ( SAA ) , haptoglobin , transferrin , IL-1beta and TNF-alpha were measured at hours 0 , 6 , 12 , 24 and 48 . RESULTS The median time to recovery in those treated with IFN and placebo was not significantly different , while the leucocytosis and high levels of fibrinogen were significantly more prolonged in placebo-treated patients . CRP and SAA were extremely elevated and peaked at 24h , remaining less marked in the IFN-treated patients but the difference was not statistically significant . Observations regarding the other parameters were unremarkable . CONCLUSIONS Although there were some clues indicating a depressed inflammatory response with IFN , we could not demonstrate a definitive effect of this agent in this double-blind trial . The drug may suppress the acute inflammation of FMF only if administered at the earliest phase . CRP and SAA may be more sensitive indicators of an attack than ESR or fibrinogen Familial Mediterranean fever ( FMF ) , the most common monogenic autoinflammatory disease , is characterized by recurrent self-limited attacks of fever and serositis . Between 5 % and 10 % of patients are resistant to or intolerant of colchicine , the current st and ard of care ( 1 ) . Pyrin , the mutated protein in FMF , has an important role in the regulation of interleukin-1 ( IL-1 ) activation . This knowledge has led to the effective use of IL-1 inhibitors in 50 reported patients with colchicine-resistant FMF , including in one controlled study ( 2,3 ) . In the present study we assessed the efficacy and safety of canakinumab , a selective , fully human anti – IL-1 monoclonal antibody with a terminal half-life of 26 days , in the treatment of children with colchicine-resistant FMF . This 6-month , phase II , open-label , single-arm study ( clinical trials.gov identifier NCT01148797 ) was conducted in 7 Caucasian children with FMF ( 5 boys and 2 girls ; median age 9.5 years [ range 6.8–14.9 ] ) at 2 centers in Israel ( Rambam Medical Center and Shaare Zedek Medical Center ) . The study was approved by the ethics committees at both hospitals , and informed consent was obtained from the parents/legal guardians of the participants . Patients were diagnosed according to the Tel-Hashomer criteria ( 4 ) , with 2 exon 10 mutations on the MEFV gene ( M694V/M694V in 5 , M694V/ V726A in 1 , and M694V/M680I in 1 ) . Participants were all colchicine resistant , having had 3 well-documented acute FMF attacks during the 3 months prior to screening despite treatment with colchicine at 1–2 mg/day ( based on age ) for at least 3 months . Following successful screening , participants were enrolled in a 30-day run-in period . Those who experienced 1 investigator-confirmed FMF attack during this time were eligible for treatment . In addition to continuing daily colchicine treatment at the usual dosage , participants received 3 subcutaneous injections ( 4 weeks apart ) of canakinumab 2 mg/kg ( maximum 150 mg ) , with the first injection ( day 1 ) administered during the next attack following the run-in period . The dose was doubled to 4 mg/kg ( maximum 300 mg ) if an attack occurred between the day 1 and day 29 visits . Day 86 was considered the end of the treatment period ( 4 weeks after administration of the last dose of canakinumab ) . Participants were followed up for another 2 visits ( that occurred between day 126 and 160 ) or until an attack occurred ( whichever occurred first ) . Attacks were then treated with acetaminophen and /or nonsteroidal antiinflammatory drugs only . The primary outcome measure was the proportion of participants with 50 % reduction in the frequency of FMF attacks during the treatment period versus the pretreatment period . Secondary outcome measures included acute-phase reactant levels , health-related quality of life ( Child Health Question naire— Parent Form 50 [ CHQ-PF50 ] ) ( 5 ) , physician ’s global assessment of FMF control , time to attack following the last canakinumab injection ( day 57 ) , and safety and tolerability of canakinumab . Six participants met the primary outcome measure with a 50 % reduction ( range 76–100 % ) in the rate of FMF attacks ( Figure 1 ) . The median 28-day time-adjusted attack rate decreased from 2.7 to 0.3 ( 89 % ) . Three participants did not experience any attacks during the treatment phase . The canakinumab dose was doubled for the second and third injections in 2 participants : a responder who experienced 1 additional brief attack after dose escalation and the single nonresponder , who experienced 3 additional attacks ( 4 attacks overall ) . Compared with 34 attacks over 374 patient-days of followup during the pretreatment phase , only 8 attacks in 601 patient-days were reported during the treatment phase . The proportion of days that participants were experiencing an attack decreased from 24.2 % to 3.6 % . Eighteen of 34 attacks ( 53 % ) were rated as severe or very severe during the pretreatment phase , compared with 0 of 8 during the treatment phase . Following the first injection , clinical manifestations resolved the same day in 4 participants and within 24 hours in 3 . Five participants developed an attack after the last canakinumab injection , within a median of 25 days ( range 5–34 ) . Median C-reactive protein levels normalized by day 8 ( from 74 mg/liter at baseline to 2 mg/liter on day 8 and 1.3 mg/liter on day 86 ) , the erythrocyte sedimentation rate by day 29 ( from 83 mm/hour at baseline to 17 mm/hour on days 29 and 86 ) , and serum amyloid A levels by day 57 ( from 500 mg/liter at baseline to 2.5 mg/liter on day 57 and 12.2 mg/liter on day 86 ) . Health-related quality of life also improved , with an increase in CHQ-PF50 summary scores for both the physical domain ( from a median of 21 at baseline to 46 on day 86 [ mean 50 in the healthy population ] ) and the psychosocial domain ( 31 to 40 ) . The physician ’s global assessment of FMF control at baseline was rated as very poor in 3 participants , poor in 3 , and fair in 1 . By day 86 this had improved to very good in 4 participants and good in 3 . Eleven adverse events ( AEs ) were reported in 4 participants ; 2 were infections . All were mild except for 1 moderate streptococcal throat infection . There were no serious AEs , opportunistic infections , malignancies , or deaths . No significant laboratory abnormalities occurred , and formation of neutralizing antibodies to canakinumab was not observed . No participants discontinued the study or missed a treatment dose because of an AE . The major limitation of this study , which was primarily a proof-of-concept study , was the small sample size . Of note , the proportion of complete responders ( with no attacks ) was lower than has been reported in studies of other autoinflammatory conditions treated with canakinumab , such as cryopyrin-associated periodic syndrome ( 6 ) and tumor necrosis factor receptor – associated periodic syndrome ( 7 ) , but higher than has been reported in systemic juvenile idiopathic arthritis ( 8) . This may be due in part to the selection , for the present study , of patients whose FMF was severe and resistant to colchicine treatment . The proportion of complete responders was slightly greater in this study than in a r and omized trial of rilonacept treatment in a similar FMF population ( 3 ) OBJECTIVES Modified adult disease severity scoring systems are being used for childhood FMF . We aim to test the clinical consistency of two common severity scoring systems and to evaluate the correlation of scores with the type of FMF mutations in paediatric FMF patients since certain mutations are prone to severe disease . METHODS Two hundred and fifty-eight children with FMF were cross-sectionally studied . Assessment of the disease severity was performed by using the modified scoring systems of Mor et al. and Pras et al. Genetic analysis was performed using PCR and restriction endonuclease digestion methods for the presence of 15 FMF gene mutations . FMF mutations were grouped into three based on well-known genotypic-phenotypic associations . Correlation between the mutation groups and the severity scoring systems was assessed . The consistency of the severity scoring systems was evaluated . RESULTS The results of two scoring systems were not statistically consistent with each other ( κ = 0.171 ) . This inconsistency persisted even in a more homogeneous subgroup of patients with only homozygote mutations of M694V , M680I and M694I ( κ = 0.125 ) . There was no correlation between the mutation groups and either of the scoring systems ( P = 0.002 , r = 0,196 for scoring systems of Mor et al. ; P = 0.009 , r = 0.162 for Pras et al. ) . CONCLUSIONS The inconsistency of the two scoring systems and lack of correlation between the scoring systems and mutation groups raises concerns about the reliability of these scoring systems in children . There is a need to develop a scoring system in children based on a prospect i ve registry Nine patients with familial Mediterranean fever ( FMF ) were admitted to a controlled , double-blind trial to determine if there are patients with this disease who are able to abort their acute episodes of pain and fever with short courses of colchicine taken at the onset of attacks . Five patients completed their treatment assignments , and colchicine was significantly effective in aborting the attacks of three but was ineffective in two . The remaining four patients could not be assessed because of insufficient numbers of courses . During the 10 months of the trial , 28 courses of colchicine and 31 of placebo were taken during the early stages of FMF attacks . Twenty-one ( 75 % ) colchicine courses were followed by attacks considered to have been aborted , compared to only three ( 10 % ) placebo courses . This trial shows that patients can recognize the prodrome of their FMF attacks and that some patients can consistently abort their attacks with short courses of colchicine taken at the very onset of symptoms Double blind , r and omized , placebo controlled pilot study of ImmunoGuard -- a st and ardized fixed combination of And rographis paniculata Nees . , Eleutherococcus senticosus Maxim . , Schiz and ra chinensis Bail . , and Glycyrrhiza glabra L. special extracts st and ardized for the content of And rographolide ( 4 mg/tablet ) , Eleuteroside E , Schis and rins and Glycyrrhizin , was carried out in two parallel groups of patients . The study was conducted in 24 ( 3 - 15 years of both genders ) patients with Familial Mediterranean Fever ( FMF ) , 14 were treated with tablets of series A ( verum ) and 10 patients received series B product ( placebo ) . The study medication was taken three times of four tablets daily for 1 month . Daily dose of the and rographolide--48 mg . The primary outcome measures in physician 's evaluation were related to duration , frequency and severity of attacks in FMF patients ( attacks characteristics score ) . The patient 's self-evaluation was based mainly on symptoms -- abdominal , chest pains , temperature , arthritis , myalgia , erysipelas-like erythema . All of 3 features ( duration , frequency , severity of attacks ) showed significant improvement in the verum group as compared with the placebo . In both clinical and self evaluation the severity of attacks was found to show the most significant improvement in the verum group . Both the clinical and laboratory results of the present phase II ( pilot ) clinical study suggest that ImmunoGuard is a safe and efficacious herbal drug for the management of patients with FMF BACKGROUND Currently , there is no proven alternative therapy for patients with familial Mediterranean fever ( FMF ) that is resistant to or intolerant of colchicine . Interleukin-1 is a key proinflammatory cytokine in FMF . OBJECTIVE To assess the efficacy and safety of rilonacept , an interleukin-1 decoy receptor , in treating patients with colchicine-resistant or -intolerant FMF . DESIGN R and omized , double-blind , single-participant alternating treatment study . ( Clinical Trials.gov number : NCT00582907 ) . SETTING 6 U.S. sites . PATIENTS Patients with FMF aged 4 years or older with 1 or more attacks per month . INTERVENTION One of 4 treatment sequences that each included two 3-month courses of rilonacept , 2.2 mg/kg ( maximum , 160 mg ) by weekly subcutaneous injection , and two 3-month courses of placebo . MEASUREMENTS Differences in the frequency of FMF attacks and adverse events between rilonacept and placebo . RESULTS 8 males and 6 females with a mean age of 24.4 years ( SD , 11.8 ) were r and omly assigned . Among 12 participants who completed 2 or more treatment courses , the rilonacept-placebo attack risk ratio was 0.59 ( SD , 0.12 ) ( equal-tail 95 % credible interval , 0.39 to 0.85 ) . The median number of attacks per month was 0.77 ( 0.18 and 1.20 attacks in the first and third quartiles , respectively ) with rilonacept versus 2.00 ( 0.90 and 2.40 , respectively ) with placebo ( median difference , -1.74 [ 95 % CI , -3.4 to -0.1 ] ; P = 0.027 ) . There were more treatment courses of rilonacept without attacks ( 29 % vs. 0 % ; P = 0.004 ) and with a decrease in attacks of greater than 50 % compared with the baseline rate during screening ( 75 % vs. 35 % ; P = 0.006 ) than with placebo . However , the duration of attacks did not differ between placebo and rilonacept ( median difference , 1.2 days [ -0.5 and 2.4 days in the first and third quartiles , respectively ] ; P = 0.32 ) . Injection site reactions were more frequent with rilonacept ( median difference , 0 events per patient treatment month [ medians of -4 and 0 in the first and third quartiles , respectively ] ; P = 0.047 ) , but no differences were seen in other adverse events . LIMITATION Small sample size , heterogeneity of FMF mutations , age , and participant indication ( colchicine resistance or intolerance ) were study limitations . CONCLUSION Rilonacept reduces the frequency of FMF attacks and seems to be a treatment option for patients with colchicine-resistant or -intolerant FMF . PRIMARY FUNDING SOURCE U.S. Food and Drug Administration , Office of Orphan Products Development To determine whether colchicine prevents or ameliorates amyloidosis in patients with familial Mediterranean fever , we followed 1070 patients with the latter disease for 4 to 11 years after they were advised to take colchicine to prevent febrile attacks . Overall , at the end of the study , the prevalence of nephropathy was one third of that in a study conducted before colchicine was used to treat familial Mediterranean fever . Among 960 patients who initially had no evidence of amyloidosis , proteinuria appeared in 4 who adhered to the prophylactic schedule and in 16 of 54 who admitted non-compliance . Life-table analysis showed that the cumulative rate of proteinuria was 1.7 percent ( 90 percent confidence limits , 0.0 and 11.3 percent ) after 11 years in the compliant patients and 48.9 percent ( 18.8 and 79.0 percent ) after 9 years in the noncompliant patients ( P less than 0.0001 ) . A total of 110 patients had overt nephropathy when they started to take colchicine . Among 86 patients who had proteinuria but not the nephrotic syndrome , proteinuria resolved in 5 and stabilized in 68 ( for more than eight years in 40 ) . Renal function deteriorated in 13 of the patients with proteinuria and in all of the 24 patients with the nephrotic syndrome or uremia . We conclude that colchicine prevented amyloidosis in our high-risk population and that it can prevent additional deterioration of renal function in patients with amyloidosis who have proteinuria but not the nephrotic syndrome OBJECTIVE To evaluate the efficacy and safety of weekly intravenous ( IV ) colchicine , in addition to oral colchicine therapy , in a subset of patients with familial Mediterranean fever ( FMF ) unresponsive to oral colchicine prophylaxis . METHODS Thirteen patients with frequent FMF attacks , despite oral doses of 2 - 3 mg/day colchicine , were treated with weekly IV injections of 1 mg colchicine for 12 weeks in an open-label pilot study . Patients were evaluated periodically for the number and severity of their attacks , use of analgesics , and erythrocyte sedimentation rate ( ESR ) . RESULTS A 50 % reduction in attack frequency and attack severity in at least one site was achieved by 10 and 6 of the 13 study patients , respectively ( p < 0.001 and p < 0.01 ) . Mean number of abdominal attacks declined significantly from 4.2 + /- 3.0 per patient at baseline to 1.9 + /- 2.6 attacks at the end of the third month of the study ( p = 0.0002 ) . The mean severity of abdominal attacks declined from a baseline of 6.1 + /- 0.95 to 3.9 + /- 2.8 after 3 months ( p = 0.02 ) . Comparable significant change was observed in chest attacks , ESR , and number of analgesic tablets used . Joint attacks were unrelieved during the study period . The treatment was safe and well tolerated , without side effects . CONCLUSION Treatment with weekly IV colchicine injections in addition to oral colchicine therapy is effective and safe in patients with FMF refractory to oral colchicine Abstract Eleven patients with long st and ing familial Mediterranean fever were studied in a double-blind trial using daily colchicine or placebo . During 60 courses of placebo , 38 attacks of familial |
1,373 | 20,427,301 | Existing evidence is confined to the promotion of safe self-management of medication , most notably relating to the self-management of oral anticoagulants | BACKGROUND There is growing international interest in involving patients in interventions to promote and support them in securing their own safety .
This paper reports a systematic review of evaluations of the effectiveness of interventions that have been used with the explicit intention of promoting patient involvement in patient safety in healthcare . | A new patient-initiated , pharmacy-based postmarketing surveillance system is described . At the time a new prescription for a targeted drug was filled , 2705 out patients ( experimentals ) r and omly assigned to the new system had a printed notice attached to their medication bags : the information requested them to report any " new or unusual symptoms " during the next 2 weeks by a toll-free telephone number to a trained nonprofessional who conducted a st and ardized adverse drug reaction ( ADR ) interview . To help vali date the new system , another sample of 1109 patients ( controls ) did not receive a request for self-monitoring but were interviewed by telephone 2 weeks later . Target drugs were chosen from two classes for which side effect profiles are well identified : oral antibiotics and tricyclic antidepressants . Results show that within both drug classes , all patient-initiated reports closely matched those obtained from controls ; the experimental and control groups also reported predictably high relative frequencies for the most commonly expected ADRs . Additional analyses suggest that a patient-initiated monitoring system could prove to be a promising complement to existing physician-based surveillance systems BACKGROUND Hospitalization and subsequent discharge home often involve discontinuity of care , multiple changes in medication regimens , and inadequate patient education , which can lead to adverse drug events ( ADEs ) and avoidable health care utilization . Our objectives were to identify drug-related problems during and after hospitalization and to determine the effect of patient counseling and follow-up by pharmacists on preventable ADEs . METHODS We conducted a r and omized trial of 178 patients being discharged home from the general medicine service at a large teaching hospital . Patients in the intervention group received pharmacist counseling at discharge and a follow-up telephone call 3 to 5 days later . Interventions focused on clarifying medication regimens ; review ing indications , directions , and potential side effects of medications ; screening for barriers to adherence and early side effects ; and providing patient counseling and /or physician feedback when appropriate . The primary outcome was rate of preventable ADEs . RESULTS Pharmacists observed the following drug-related problems in the intervention group : unexplained discrepancies between patients ' preadmission medication regimens and discharge medication orders in 49 % of patients , unexplained discrepancies between discharge medication lists and postdischarge regimens in 29 % of patients , and medication nonadherence in 23 % . Comparing trial outcomes 30 days after discharge , preventable ADEs were detected in 11 % of patients in the control group and 1 % of patients in the intervention group ( P = .01 ) . No differences were found between groups in total ADEs or total health care utilization . CONCLUSIONS Pharmacist medication review , patient counseling , and telephone follow-up were associated with a lower rate of preventable ADEs 30 days after hospital discharge . Medication discrepancies before and after discharge were common targets of intervention Eighty anxious and eighty depressed patients were assigned r and omly to receiving one of three versions of an information leaflet about their medication , or to receiving no leaflet at all . Mean medication errors were reduced from 15 to 4 % by provision of suitably constructed leaflets . The results show the practical importance of informing patients about their medication and of paying attention to the difficulty level of any leaflets issued The 24.89 % of Mastomys spp of the total rodents caught in this study is an indication that the number ofMastomys spp in this locality is on the increase compared to the report by Agbonlahor1 who stated that Mastomys spp accounts for about 17.5 % rodents in this locality . The fact that 46.76 % of these were positive for LVCFA is an indication that the spread of the virus is on the increase , especially relative to the high number of Mastomys spp circulating in Ekpoma and its environs . This may account for persistent outbreaks of Lassa fever in Ekpoma . It is believed that these rodents may find their way into homes when their natural habitat is disturbed by farmers operating bush clearing and through indiscriminate bush burning – factors which were suggested to have caused the 1989 outbreak in Ekpoma1 . The fact that non-Mastomys spp in the study were negative for LVCFA shows that only M. natalensis is responsible for the transmission of the virus . The findings of a high ( 46.79 % ) circulating antibody to Lassa virus amongst an increasing prevalence ( 24.89 % ) of M. natalensis in Ekpoma and its environs is of great importance . This disease can be prevented by clearing the bushes around the homes and by maintaining good hygiene when h and ling food An interactive computer program ( Personal Education Program [ PEP ] ) design ed for the learning styles and psychomotor skills of older adults was used to teach older adults about potential drug interactions that can result from self-medication with over-the-counter ( OTC ) agents and alcohol . Subjects used the PEP on notebook computers equipped with infrared sensitive touchscreens . Subjects were recruited from senior centers . Those who met age , vision , literacy , independence , and medication use criteria were r and omly assigned to one of three groups : ( 1 ) PEP plus information booklet ; ( 2 ) information booklet only ; or ( 3 ) control . A repeated measures ( three time periods 2 weeks apart ) , three-group design was used . Users of PEP had significantly greater knowledge and self-efficacy scores than both the conventional and control groups at all three time points . The PEP group reported fewer adverse self-medication behaviors over time . Reported self-medication behaviors did not change over time for either the conventional or control groups . Subjects indicated a high degree of satisfaction with the PEP and reported their intent to make specific changes in self-medication behaviors BACKGROUND Patient safety ' best practice s ' that call for patient participation to prevent adverse drug events have not been rigorously evaluated . OBJECTIVE To consider lessons learned from a patient partnership intervention to prevent adverse drug events among medical in- patients . DESIGN Prospect i ve r and omized , controlled pilot trial . SETTING Boston teaching hospital . Patients . Two hundred and nine adult in- patients on a general medicine unit . INTERVENTION Intervention patients ( n = 107 ) received drug safety information and their medication list ; controls ( n = 102 ) received drug safety information only . Measurements . Adverse drug events and close-call drug errors were identified using chart review and incident reports from nurses , pharmacists , and physicians . Patients and clinicians were surveyed about the intervention . RESULTS In 1053 patient-days at risk , 11 patients experienced 12 adverse drug events and 16 patients experienced 18 close calls . There was a non-significant difference between intervention patients and controls in survey responses and in the adverse drug event rate ( 8.4 % versus 2.9 % , P = 0.12 ) and close-call rate ( 7.5 % versus 9.8 % , P = 0.57 ) . Eleven percent of patients were aware of drug-related mistakes during the hospitalization . Among nurse respondents , 29 % indicated that at least one medication error was prevented when a patient or family member identified a problem . CONCLUSION Partnering with in- patients to prevent adverse drug events is a promising strategy but requires further study to document its efficacy OBJECTIVE To determine the effect of an inpatient self-medication program ( SMP ) on the ability to self-medicate , patient medication knowledge , compliance , and patient morale . DESIGN R and omized controlled clinical trial . POPULATION One hundred seven consecutive patients admitted to a geriatric assessment and rehabilitation program were r and omized to either participate in the SMP or to receive st and ard care . INTERVENTION The SMP was a three-stage program in which patients were given increasing responsibility for the administration of their own medications . MEASUREMENTS Ability to self-medicate on discharge from hospital ; medication compliance at 1 month ; patient medication knowledge ; Philadelphia Morale Scale . MAIN RESULTS Participation in the self-medication program did not increase the proportion of patients who were able to self-medicate on discharge from hospital . Compliance was improved by the program . On a proportional basis , the self-medication group made significantly fewer medication errors than the control group at 1-month follow-up ( 0.045 vs 0.086 , P < .001 ) . There were no significant differences in morale or medication knowledge between the SMP and control groups , although both groups made significant gains in knowledge about the names , administration times , and purpose s of their medications from admission to follow-up ( P < .001 ) . CONCLUSIONS A SMP can improve compliance in geriatric patients who are discharged to the community . Participation in a SMP does not improve patients ' morale nor does it improve their medication knowledge more than pharmacy counselling alone . Participation in a SMP is unlikely to increase the probability that patients will be able to self-medicate on discharge . Cognitive factors limit patients ' ability to self-medicate BACKGROUND A systematic study into outpatient medication reconciliation was conducted to determine if a multifaceted intervention influencing providers and patients reduced discrepancies related to inadequate prescription medication reconciliation in an outpatient setting . METHODS A prospect i ve trial was conducted on 104 primary care patients at the Mayo Clinic . Patients in Phase I received st and ard care . Patients in Phase II received the intervention reconciliation process , which consisted of ( 1 ) mailed letters before appointments to remind patients to bring medication bottles or up date d medication lists to their visits , ( 2 ) verification , and ( 3 ) correction of the medication list in the electronic medical record by the patient , and academic detailing and weekly audit and feedback of performance . RESULTS Interventions result ed in a decrease in prescription medication errors from 88.9 % of the visits in Phase 1 to 66 % of the visits in Phase II ( p = .005 ) and from 98.2 % of the visits in Phase I to 84 % of the visits in Phase II ( p = .0134 ) when all medications were considered . The average number of discrepancies per patient decreased by more than 50 % from 5.24 in Phase I to 2.46 in Phase II . The majority of discrepancies were minor . DISCUSSION A multifaceted intervention including various members of the health care provider team ( and the patient ) is crucial to enhancing medication reconciliation OBJECTIVE To determine whether parental errors in dosing liquid medication can be decreased through education . DESIGN R and omized convenience sample stratified to three study groups . SETTING General pediatric clinic , largely indigent and Latino . PATIENTS A total of 45 English-speaking and 45 Spanish-speaking children diagnosed with otitis media and treated with an antibiotic suspension . INTERVENTION Group 1 patients received the prescription and verbal instructions . Group 2 patients received the prescription and a syringe , then the correct dose was demonstrated . Group 3 patients received the prescription , a syringe with a line marked at the correct dose , and a demonstration . After returning from the pharmacy , parents administered the medication under observation . Parents in group 1 used a dispensing device similar to that planned for home use . The other groups used the syringe . After observation but before discharge , everyone received a syringe with a line marked at the correct dose . Patients were seen again at approximately 1 month , and parents demonstrated how much medication they had administered . MAIN OUTCOME MEASURE Percent of parents who administered the correct dose . RESULTS Patients in group 1 received between 32 % and 147 % of the correct dose , with only 11 of 30 ( 37 % ) receiving the correct dose ( + /-0.2 mL ) . In group 2 , 25 of 30 ( 83 % ) parents administered the correct dose , and in group 3 , 30 of 30 ( 100 % ) gave the correct dose . Simultaneous logistic regression indicated that accuracy of dosage differed across instructional groups and language . At follow-up , 23 of 26 parents demonstrated the correct dose . CONCLUSION Education can decrease medication dosing errors made by both Spanish-speaking and English-speaking parents . Effectiveness was also shown at follow-up Objectives : To estimate the extent , nature and consequences of adverse events in a large National Health Service ( NHS ) hospital , and to evaluate the reliability of a two-stage casenote review method in identifying adverse events . Design : A two-stage structured retrospective patient casenote review . Setting : A large NHS hospital in Engl and . Population : A r and om sample of 1006 hospital admissions between January and May 2004 : surgery ( n = 311 ) , general medicine ( n = 251 ) , elderly ( n = 184 ) , orthopaedics ( n = 131 ) , urology ( n = 61 ) and three other specialties ( n = 68 ) . Main outcome measures : Proportion of admissions with adverse events , the proportion of preventable adverse events , and the types and consequences of adverse events . Results : 8.7 % ( n = 87 ) of the 1006 admissions had at least one adverse event ( 95 % CI 7.0 % to 10.4 % ) , of which 31 % ( n = 27 ) were preventable . 15 % of adverse events led to impairment or disability which lasted more than 6 months and another 10 % contributed to patient death . Adverse events led to a mean increased length of stay of 8 days ( 95 % CI 6.5 to 9 ) . The sensitivity of the screening criteria in identifying adverse events was 92 % ( 95 % CI 87 % to 96 % ) and the specificity was 62 % ( 95 % CI 53 % to 71 % ) . Inter-rater reliability for determination of adverse events was good ( κ = 0.64 ) , but for the assessment of preventability it was only moderate ( κ = 0.44 ) . Conclusion : This study confirms that adverse events are common , serious and potentially preventable source of harm to patients in NHS hospitals . The accuracy and reliability of a structured two-stage casenote review in identifying adverse events in the UK was confirmed OBJECTIVE To assess two interventions for improving the accuracy of doctors ' information about their patients ' medication . DESIGN AND SETTING A 12-month two-armed ( parallel design ed ) prospect i ve study among elderly patients of four general practitioners ( GPs ) in two local government areas of Sydney 's North Shore . PATIENTS 206 elderly , ambulant , self-caring patients ( 69 men , 137 women ; median age , 75 year ; range , 60 - 94 years ) . INTERVENTION Patients were issued with a medication record card ( MRC ) , filled in by their GPs with what they believed to be the patient 's current medications , and were asked to produce it at all subsequent consultations . Patients of two of the GPs were additionally asked to bring their currently used medications to all scheduled appointments . MAIN OUTCOME MEASURE Accuracy of the MRC , determined by confirmatory home visits and inspection of medications by a pharmacist . RESULTS The proportion of patients with regimens recorded accurately on their MRCs improved significantly ( from 25.9 % to 42.0 % ) only in the group asked to bring their medications to consultations ( P = 0.03 ) . Most errors of recording were of omission , with patients taking a median of two medications ( range , 0 - 10 ) of which their GPs were not aware . CONCLUSION Requesting that patients bring their medications to consultations , in conjunction with the use of medication record cards , can improve information for doctors about their patients ' medications |
1,374 | 27,155,214 | Without increasing hypoglycaemia , SGLT2 inhibitors showed better glycaemic control and greater weight reduction than DPP4 inhibitors in patients with T2DM inadequately controlled with insulin . | BACKGROUND Both sodium glucose cotransporter 2 ( SGLT2 ) inhibitors and dipeptidyl peptidase-4 ( DPP4 ) inhibitors can be used to treat patients with type 2 diabetes mellitus ( T2DM ) that is inadequately controlled with insulin therapy , and yet there has been no direct comparison of these two inhibitors .
CONCLUSIONS Sodium glucose cotransporter 2 inhibitors achieved better glycaemic control and greater weight reduction than DPP4 inhibitors without increasing the risk of hypoglycaemia in patients with T2DM that is inadequately controlled with insulin .
There has been no direct comparison of SGLT2 inhibitors and DPP4 inhibitors in patients with T2DM inadequately controlled with insulin therapy .
In this study , we performed indirect meta- analysis comparing SGLT2 inhibitors and DPP4 inhibitors added to insulin therapy . | OBJECTIVE We investigated the efficacy and safety of the sodium glucose cotransporter 2 inhibitor , empagliflozin , added to multiple daily injections of insulin ( MDI insulin ) in obese patients with type 2 diabetes mellitus ( T2DM ) . RESEARCH DESIGN AND METHODS Patients inadequately controlled on MDI insulin ± metformin ( mean HbA1c 8.3 % [ 67 mmol/mol ] ; BMI 34.8 kg/m2 ; insulin dose 92 international units/day ) were r and omized and treated with once-daily empagliflozin 10 mg ( n = 186 ) , empagliflozin 25 mg ( n = 189 ) , or placebo ( n = 188 ) for 52 weeks . Insulin dose was to remain stable in weeks 1–18 , adjusted to meet glucose targets in weeks 19–40 , then stable in weeks 41–52 . The primary end point was change from baseline in HbA1c at week 18 . Secondary end points were changes from baseline in insulin dose , weight , and HbA1c at week 52 . RESULTS Adjusted mean ± SE changes from baseline in HbA1c were −0.50 ± 0.05 % ( −5.5 ± 0.5 mmol/mol ) for placebo versus −0.94 ± 0.05 % ( −10.3 ± 0.5 mmol/mol ) and −1.02 ± 0.05 % ( −11.1 ± 0.5 mmol/mol ) for empagliflozin 10 mg and empagliflozin 25 mg , respectively , at week 18 ( both P < 0.001 ) . At week 52 , further reductions with insulin titration result ed in changes from baseline in HbA1c of −0.81 ± 0.08 % ( −8.9 ± 0.9 mmol/mol ) , −1.18 ± 0.08 % ( −12.9 ± 0.9 mmol/mol ) , and −1.27 ± 0.08 % ( −13.9 ± 0.9 mmol/mol ) with placebo , empagliflozin 10 mg , and empagliflozin 25 mg , respectively , and final HbA1c of 7.5 % ( 58 mmol/mol ) , 7.2 % ( 55 mmol/mol ) , and 7.1 % ( 54 mmol/mol ) , respectively . More patients attained HbA1c < 7 % ( < 53 mmol/mol ) with empagliflozin ( 31–42 % ) versus placebo ( 21 % ; both P < 0.01 ) . Empagliflozin 10 mg and empagliflozin 25 mg reduced insulin doses ( −9 to −11 international units/day ) and weight ( −2.4 to −2.5 kg ) versus placebo ( all P < 0.01 ) at week 52 . CONCLUSIONS In obese , difficult-to-treat patients with T2DM inadequately controlled on high MDI insulin doses , empagliflozin improved glycemic control and reduced weight without increasing the risk of hypoglycemia and with lower insulin requirements Aims /hypothesisType 2 diabetes is difficult to manage in patients with a long history of disease requiring insulin therapy . Moreover , addition of most currently available oral antidiabetic agents increases the risk of hypoglycaemia . Vildagliptin is a dipeptidyl peptidase-IV inhibitor , which improves glycaemic control by increasing pancreatic beta cell responsiveness to glucose and suppressing inappropriate glucagon secretion . This study assessed the efficacy and tolerability of vildagliptin added to insulin therapy in patients with type 2 diabetes . Material s and methods This was a multicentre , 24-week , double-blind , r and omised , placebo-controlled , parallel-group study in patients with type 2 diabetes that was inadequately controlled ( HbA1c = 7.5–11 % ) by insulin . Patients received vildagliptin ( n = 144 ; 50 mg twice daily ) or placebo ( n = 152 ) while continuing insulin therapy . Results Baseline HbA1c averaged 8.4 ± 0.1 % in both groups . The adjusted mean change from baseline to endpoint ( AMΔ ) in HbA1c was −0.5 ± 0.1 % and −0.2 ± 0.1 % in patients receiving vildagliptin or placebo , respectively , with a significant between-treatment difference ( p = 0.01 ) . In patients aged ≥65 years , the AMΔ HbA1c was −0.7 ± 0.1 % in the vildagliptin group vs −0.1 ± 0.1 % in the placebo group ( p < 0.001 ) . The incidence of adverse events was similar in the vildagliptin ( 81.3 % ) and placebo ( 82.9 % ) groups . However , hypoglycaemic events were less common ( p < 0.001 ) and less severe ( p < 0.05 ) in patients receiving vildagliptin than in those receiving placebo . Conclusions /interpretationVildagliptin decreases HbA1c in patients whose type 2 diabetes is poorly controlled with high doses of insulin . Addition of vildagliptin to insulin therapy is also associated with reduced confirmed and severe hypoglycaemia . Clinical Trials.gov ID no. : NCT 00099931 Aims To investigate the efficacy and tolerability of empagliflozin added to basal insulin‐treated type 2 diabetes . Methods Patients inadequately controlled [ glycated haemoglobin ( HbA1c ) > 7 to ≤10 % ( > 53 to ≤86 mmol/mol ) ] on basal insulin ( glargine , detemir , NPH ) were r and omized to empagliflozin 10 mg ( n = 169 ) , empagliflozin 25 mg ( n = 155 ) or placebo ( n = 170 ) for 78 weeks . The baseline characteristics were balanced among the groups [ mean HbA1c 8.2 % ( 67 mmol/mol ) , BMI 32.2 kg/m2 ] . The basal insulin dose was to remain constant for 18 weeks , then could be adjusted at investigator 's discretion . The primary endpoint was change from baseline in HbA1c at week 18 . Key secondary endpoints were changes from baseline in HbA1c and insulin dose at week 78 . Results At week 18 , the adjusted mean ± st and ard error changes from baseline in HbA1c were 0.0 ± 0.1 % ( −0.1 ± 0.8 mmol/mol ) for placebo , compared with −0.6 ± 0.1 % ( −6.2 ± 0.8 mmol/mol ) and −0.7 ± 0.1 % ( −7.8 ± 0.8 mmol/mol ) for empagliflozin 10 and 25 mg , respectively ( both p < 0.001 ) . At week 78 , empagliflozin 10 and 25 mg significantly reduced HbA1c , insulin dose and weight vs placebo ( all p < 0.01 ) , and empagliflozin 10 mg significantly reduced systolic blood pressure vs placebo ( p = 0.004 ) . Similar percentages of patients had confirmed hypoglycaemia in all groups ( 35–36 % ) . Events consistent with urinary tract infection were reported in 9 , 15 and 12 % of patients on placebo , empagliflozin 10 and 25 mg , and events consistent with genital infection were reported in 2 , 8 and 5 % , respectively . Conclusions Empagliflozin for 78 weeks added to basal insulin improved glycaemic control and reduced weight with a similar risk of hypoglycaemia to placebo OBJECTIVE To evaluate the efficacy and tolerability of sitagliptin when added to insulin therapy alone or in combination with metformin in patients with type 2 diabetes . METHODS After a 2 week placebo run-in period , eligible patients inadequately controlled on long-acting , intermediate-acting or premixed insulin ( HbA1c > or = 7.5 % and < or = 11 % ) , were r and omised 1:1 to the addition of once-daily sitagliptin 100 mg or matching placebo over a 24-week study period . The study capped the proportion of r and omised patients on insulin plus metformin at 75 % . Further , the study capped the proportion of r and omised patients on premixed insulin at 25 % . The metformin dose and the insulin dose were to remain stable throughout the study . The primary endpoint was HbA1c change from baseline at week 24 . RESULTS Mean baseline characteristics were similar between the sitagliptin ( n = 322 ) and placebo ( n = 319 ) groups , including HbA1c ( 8.7 vs. 8.6 % ) , diabetes duration ( 13 vs. 12 years ) , body mass index ( 31.4 vs. 31.4 kg/m(2 ) ) , and total daily insulin dose ( 51 vs. 52 IU ) , respectively . At 24 weeks , the addition of sitagliptin significantly ( p < 0.001 ) reduced HbA1c by 0.6 % compared with placebo ( 0.0 % ) . A greater proportion of patients achieved an HbA1c level < 7 % while r and omised to sitagliptin as compared with placebo ( 13 vs. 5 % respectively ; p < 0.001 ) . Similar HbA1c reductions were observed in the patient strata defined by insulin type ( long-acting and intermediate-acting insulins or premixed insulins ) and by baseline metformin treatment . The addition of sitagliptin significantly ( p < 0.001 ) reduced fasting plasma glucose by 15.0 mg/dl ( 0.8 mmol/l ) and 2-h postmeal glucose by 36.1 mg/dl ( 2.0 mmol/l ) relative to placebo . A higher incidence of adverse experiences was reported with sitagliptin ( 52 % ) compared with placebo ( 43 % ) , due mainly to the increased incidence of hypoglycaemia ( sitagliptin , 16 % vs. placebo , 8 % ) . The number of hypoglycaemic events meeting the protocol -specified criteria for severity was low with sitagliptin ( n = 2 ) and placebo ( n = 1 ) . No significant change from baseline in body weight was observed in either group . CONCLUSION In this 24-week study , the addition of sitagliptin to ongoing , stable-dose insulin therapy with or without concomitant metformin improved glycaemic control and was generally well tolerated in patients with type 2 diabetes OBJECTIVE To evaluate the efficacy and long-term safety of linagliptin added to basal insulins in type 2 diabetes inadequately controlled on basal insulin with or without oral agents . RESEARCH DESIGN AND METHODS A total of 1,261 patients ( HbA1c ≥7.0 % [ 53 mmol/mol ] to ≤10.0 % [ 86 mmol/mol ] ) on basal insulin alone or combined with metformin and /or pioglitazone were r and omized ( 1:1 ) to double-blind treatment with linagliptin 5 mg once daily or placebo for ≥52 weeks . The basal insulin dose was kept unchanged for 24 weeks but could thereafter be titrated according to fasting plasma glucose levels at the investigators ’ discretion . The primary end point was the mean change in HbA1c from baseline to week 24 . The safety analysis incorporated data up to a maximum of 110 weeks . RESULTS At week 24 , HbA1c changed from a baseline of 8.3 % ( 67 mmol/mol ) by −0.6 % ( −6.6 mmol/mol ) and by 0.1 % ( 1.1 mmol/mol ) with linagliptin and placebo , respectively ( treatment difference −0.65 % [ 95 % CI −0.74 to −0.55 ] [ −7.1 mmol/mol ] ; P < 0.0001 ) . Despite the option to uptitrate basal insulin , it was adjusted only slightly upward ( week 52 , linagliptin 2.6 IU/day , placebo 4.2 IU/day ; P < 0.003 ) , result ing in no further HbA1c improvements . Frequencies of hypoglycemia ( week 24 , linagliptin 22.0 % , placebo 23.2 % ; treatment end , linagliptin 31.4 % , placebo 32.9 % ) and adverse events ( linagliptin 78.4 % , placebo 81.4 % ) were similar between groups . Mean body weight remained unchanged ( week 52 , linagliptin −0.30 kg , placebo −0.04 kg ) . CONCLUSIONS Linagliptin added to basal insulin therapy significantly improved glycemic control relative to placebo without increasing hypoglycemia or body weight OBJECTIVE To determine whether dapagliflozin , which selectively inhibits renal glucose reabsorption , lowers hyperglycemia in patients with type 2 diabetes that is poorly controlled with high insulin doses plus oral antidiabetic agents ( OADs ) . RESEARCH DESIGN AND METHODS This was a r and omized , double-blind , three-arm parallel-group , placebo-controlled , 26-center trial ( U.S. and Canada ) . Based on data from an insulin dose-adjustment setting cohort ( n = 4 ) , patients in the treatment cohort ( n = 71 ) were r and omly assigned 1:1:1 to placebo , 10 mg dapagliflozin , or 20 mg dapagliflozin , plus OAD(s ) and 50 % of their daily insulin dose . The primary outcome was change from baseline in A1C at week 12 ( dapagliflozin vs. placebo , last observation carried forward [ LOCF ] ) . RESULTS At week 12 ( LOCF ) , the 10- and 20-mg dapagliflozin groups demonstrated −0.70 and −0.78 % mean differences in A1C change from baseline versus placebo . In both dapagliflozin groups , 65.2 % of patients achieved a decrease from baseline in A1C ≥0.5 % versus 15.8 % in the placebo group . Mean changes from baseline in fasting plasma glucose ( FPG ) were + 17.8 , + 2.4 , and −9.6 mg/dl ( placebo , 10 mg dapagliflozin , and 20 mg dapagliflozin , respectively ) . Postpr and ial glucose ( PPG ) reductions with dapagliflozin also showed dose dependence . Mean changes in total body weight were −1.9 , −4.5 , and −4.3 kg ( placebo , 10 mg dapagliflozin , and 20 mg dapagliflozin ) . Overall , adverse events were balanced across all groups , although more genital infections occurred in the 20-mg dapagliflozin group than in the placebo group . CONCLUSIONS In patients receiving high insulin doses plus insulin sensitizers who had their baseline insulin reduced by 50 % , dapagliflozin decreased A1C , produced better FPG and PPG levels , and lowered weight more than placebo Introduction The objective of this study was to assess the effect of sitagliptin on insulin dose in patients with inadequately controlled type 2 diabetes who titrate basal insulin to a target fasting glucose level after initiating sitagliptin . Methods This was a multicenter , r and omized , double-blind , placebo-controlled , 24-week clinical trial in which treatment with sitagliptin 100 mg/day or placebo was administered concurrently with insulin glargine titration , targeting a fasting glucose of 4.0–5.6 mmol/L ( 72–100 mg/dL ) . The trial r and omized 660 patients with type 2 diabetes and inadequate glycemic control on insulin , with or without metformin ( ≥1500 mg/day ) or sulfonylurea , for ≥10 weeks . Patients could remain on metformin but not sulfonylurea after r and omization . Results The increase from baseline in the daily dose of insulin was less in the sitagliptin group ( N = 329 ) compared to placebo ( N = 329 ) ( between group difference = −4.7 IU [ 95 % confidence interval [ CI ] −8.3 , −1.2 ] ; p = 0.009 ) . Patients in the sitagliptin group had lower glycated hemoglobin ( HbA1c ) levels after 24 weeks ( between-group difference of −0.4 % [ 95 % CI −0.6 , −0.3 ; −4.9 mmol/mol ( 95 % CI −6.6 , −3.2 ) ] ; p < 0.001 ) , and more patients in the sitagliptin group reached the HbA1c goal of < 7.0 % ( 53 mmol/mol ) , with a between-group difference of 17.3 % ( 95 % CI 10.4 % , 24.1 % ; p < 0.001 ) . Fewer patients in the sitagliptin group experienced an adverse event of hypoglycemia ( between-group difference = −15.5 % , p < 0.001 ) . Conclusion Administration of sitagliptin prior to intensive titration of basal insulin glargine reduces the insulin dose requirement while providing superior glycemic control and less hypoglycemia , compared to an insulin-only regimen . Funding Merck & Co. , Inc. , Kenilworth , NJ , USA Chronic hyperglycemia impairs insulin action , result ing in glucotoxicity , which can be ameliorated in animal models by inducing glucosuria with renal glucose transport inhibitors . Here , we examined whether reduction of plasma glucose with a sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor could improve insulin-mediated tissue glucose disposal in patients with type 2 diabetes . Eighteen diabetic men were r and omized to receive either dapagliflozin ( n = 12 ) or placebo ( n = 6 ) for 2 weeks . We measured insulin-mediated whole body glucose uptake and endogenous glucose production ( EGP ) at baseline and 2 weeks after treatment using the euglycemic hyperinsulinemic clamp technique . Dapagliflozin treatment induced glucosuria and markedly lowered fasting plasma glucose . Insulin-mediated tissue glucose disposal increased by approximately 18 % after 2 weeks of dapagliflozin treatment , while placebo-treated subjects had no change in insulin sensitivity . Surprisingly , following dapagliflozin treatment , EGP increased substantially and was accompanied by an increase in fasting plasma glucagon concentration . Together , our data indicate that reduction of plasma glucose with an agent that works specifically on the kidney to induce glucosuria improves muscle insulin sensitivity . However , glucosuria induction following SGLT2 inhibition is associated with a paradoxical increase in EGP . These results provide support for the glucotoxicity hypothesis , which suggests that chronic hyperglycemia impairs insulin action in individuals with type 2 diabetes AIMS To assess the efficacy and safety of alogliptin added to insulin in patients with type 2 diabetes inadequately controlled with insulin alone or combined with metformin . METHODS In this 26-week , double-blind , placebo-controlled study , 390 patients were r and omized to receive alogliptin 12.5 mg ( n = 131 ) , alogliptin 25 mg ( n = 129 ) or placebo ( n = 130 ) once daily , as add-on to stable insulin therapy with or without metformin . The primary endpoint was change in haemoglobin A(1C ) ( HbA(1C ) ) at week 26 . RESULTS At week 26 , mean HbA(1C ) changes from the mean baseline value of 9.3 % were significantly greater for alogliptin 12.5 mg ( -0.63 + /- 0.08 % ) and alogliptin 25 mg ( -0.71 + /- 0.08 % ) than placebo ( -0.13 + /- 0.08 % ; p < 0.001 ) . Significantly greater proportions of patients receiving alogliptin 12.5 or 25 mg than placebo had HbA(1C ) decreases of > or = 0.5 , > or = 1.0 and > or = 1.5 % . Insulin doses remained unchanged , and there were no differences in the proportions of patients experiencing hypoglycaemia among placebo ( 24 % ) , alogliptin 12.5 mg ( 27 % ) and alogliptin 25 mg ( 27 % ) . Mean weight increases from baseline at week 26 were similar for placebo ( 0.6 + /- 0.2 kg ) , alogliptin 12.5 mg ( 0.7 + /- 0.2 kg ) and alogliptin 25 mg ( 0.6 + /- 0.2 kg ) . Incidences of overall adverse events , and of gastrointestinal , dermatological and infection-related events , were similar among groups . CONCLUSIONS Adding alogliptin to previous insulin therapy ( with or without metformin ) significantly improved glycaemic control in patients with type 2 diabetes inadequately controlled on insulin , without causing weight gain or increasing the incidence of hypoglycaemia . Further studies are warranted to explore the role of alogliptin added to optimized basal insulin regimens CONTEXT Dipeptidyl peptidase-4 inhibitors act by increasing plasma levels of glucagon-like peptide-1 and suppressing excessive glucagon secretion in patients with type 2 diabetes . However , their effects on the glucagon response to hypoglycemia are not established . OBJECTIVE The aim of the study was to assess effects of the dipeptidyl peptidase-4 inhibitor vildagliptin on alpha-cell response to hyper- and hypoglycemia . DESIGN We conducted a single-center , r and omized , double-blind , placebo-controlled , two-period crossover study of 28-d treatment , with a 4-wk between-period washout . PATIENTS We studied drug-naive patients with type 2 diabetes and baseline glycosylated hemoglobin of 7.5 % or less . INTERVENTION Participants received vildagliptin ( 100 mg/d ) or placebo as out patients . PRIMARY OUTCOME MEASURE(S ) : We measured the following : 1 ) change in plasma glucagon levels during hypoglycemic ( 2.5 mm glucose ) clamp ; and 2 ) incremental ( Delta ) glucagon area under the concentration-time curve from time 0 to 60 min ( AUC(0 - 60 min ) ) during st and ard meal test . Before the study , it was hypothesized that vildagliptin would suppress glucagon secretion during meal tests and enhance the glucagon response to hypoglycemia . RESULTS The mean change in glucagon during hypoglycemic clamp was 46.7 + /- 6.9 ng/liter with vildagliptin treatment and 33.9 + /- 6.7 ng/liter with placebo ; the between-treatment difference was 12.8 + /- 7.0 ng/liter ( P = 0.039 ) , representing a 38 % increase with vildagliptin . In contrast , the mean glucagon DeltaAUC(0 - 60 min ) during meal test with vildagliptin was 512 + /- 163 ng/liter x min vs. 861 + /- 130 ng/liter x min with placebo ; the between-treatment difference was -349 + /- 158 ng/liter x min ( P = 0.019 ) , representing a 41 % decrease with vildagliptin . CONCLUSIONS Vildagliptin enhances alpha-cell responsiveness to both the suppressive effects of hyperglycemia and the stimulatory effects of hypoglycemia . These effects likely contribute to the efficacy of vildagliptin to improve glycemic control as well as to its low hypoglycemic potential OBJECTIVES To survey the frequency of use of indirect comparisons in systematic review s and evaluate the methods used in their analysis and interpretation . Also to identify alternative statistical approaches for the analysis of indirect comparisons , to assess the properties of different statistical methods used for performing indirect comparisons and to compare direct and indirect estimates of the same effects within review s. DATA SOURCES Electronic data bases . REVIEW METHODS The Data base of Abstract s of Review s of Effects ( DARE ) was search ed for systematic review s involving meta- analysis of r and omised controlled trials ( RCTs ) that reported both direct and indirect comparisons , or indirect comparisons alone . A systematic review of MEDLINE and other data bases was carried out to identify published methods for analysing indirect comparisons . Study design s were created using data from the International Stroke Trial . R and om sample s of patients receiving aspirin , heparin or placebo in 16 centres were used to create meta-analyses , with half of the trials comparing aspirin and placebo and half heparin and placebo . Methods for indirect comparisons were used to estimate the contrast between aspirin and heparin . The whole process was repeated 1000 times and the results were compared with direct comparisons and also theoretical results . Further detailed case studies comparing the results from both direct and indirect comparisons of the same effects were undertaken . RESULTS Of the review s identified through DARE , 31/327 ( 9.5 % ) included indirect comparisons . A further five review s including indirect comparisons were identified through electronic search ing . Few review s carried out a formal analysis and some based analysis on the naive addition of data from the treatment arms of interest . Few method ological papers were identified . Some valid approaches for aggregate data that could be applied using st and ard software were found : the adjusted indirect comparison , meta-regression and , for binary data only , multiple logistic regression ( fixed effect models only ) . Simulation studies showed that the naive method is liable to bias and also produces over-precise answers . Several methods provide correct answers if strong but unverifiable assumptions are fulfilled . Four times as many similarly sized trials are needed for the indirect approach to have the same power as directly r and omised comparisons . Detailed case studies comparing direct and indirect comparisons of the same effect show considerable statistical discrepancies , but the direction of such discrepancy is unpredictable . CONCLUSIONS Direct evidence from good- quality RCTs should be used wherever possible . Without this evidence , it may be necessary to look for indirect comparisons from RCTs . However , the results may be susceptible to bias . When making indirect comparisons within a systematic review , an adjusted indirect comparison method should ideally be used employing the r and om effects model . If both direct and indirect comparisons are possible within a review , it is recommended that these be done separately before considering whether to pool data . There is a need to evaluate methods for the analysis of indirect comparisons for continuous data and for empirical research into how different methods of indirect comparison perform in cases where there is a large treatment effect . Further study is needed into when it is appropriate to look at indirect comparisons and when to combine both direct and indirect comparisons . Research into how evidence from indirect comparisons compares to that from non-r and omised studies may also be warranted . Investigations using individual patient data from a meta- analysis of several RCTs using different protocol s and an evaluation of the impact of choosing different binary effect measures for the inverse variance method would also be useful AIM The aim of this study is to assess the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to insulin in type 2 diabetes mellitus ( T2DM ) . METHODS This is a multicentre , double-blind , placebo-controlled , parallel group , clinical trial in T2DM patients inadequately controlled by stable insulin therapy , with or without metformin . Patients received treatment with vildagliptin 50 mg bid or placebo for 24 weeks . RESULTS In all , 449 patients were r and omized to vildagliptin ( n = 228 ) or placebo ( n = 221 ) . After 24 weeks , the difference in adjusted mean change in haemoglobin A1c ( HbA1c ) between vildagliptin and placebo was -0.7 ± 0.1 % ( p < 0.001 ) in the overall study population , -0.6 ± 0.1 % ( p < 0.001 ) in the subgroup also receiving metformin and -0.8 ± 0.2 % ( p < 0.001 ) in the subgroup without metformin . Vildagliptin therapy was well tolerated and had a similarly low incidence of hypoglycaemia compared with placebo ( 8.4 vs. 7.2 % , p = 0.66 ) in spite of improved glycaemic control , and was not associated with weight gain . ( + 0.1 vs. -0.4 kg ) . CONCLUSIONS Vildagliptin 50 mg bid added to insulin significantly reduced HbA1c in patients with T2DM inadequately controlled by insulin , with or without metformin . Vildagliptin was well tolerated , with a safety profile similar to placebo . These results were achieved without weight gain or an increase in hypoglycaemia incidence or severity in spite of improved glycaemic control Abstract Objective : To evaluate efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes ( T2D ) with inadequate glycemic control on insulin alone or combined with metformin . Methods : Adults ( n = 455 ) with HbA1c 7.5–11 % on stable insulin therapy ( 30–150 U/day ± metformin ) for at least 8 weeks were stratified by metformin use and r and omly assigned 2:1 to receive saxagliptin 5 mg or placebo once daily for 24 weeks . Patients were to maintain stable insulin doses but these could be decreased to reduce risk of hypoglycemia . Patients with hyperglycemia or substantially increased insulin use were rescued with a flexible insulin regimen and remained in the study . Metformin doses were kept stable . The primary efficacy endpoint was change in HbA1c from baseline to week 24 ( or rescue ) . Results : Patients treated with saxagliptin versus placebo had significantly greater reductions in adjusted mean HbA1c ( difference : −0.41 % , p < 0.0001 ) , postpr and ial glucose ( PPG ) 180-minute area under the curve ( −3829.8 mg·min/dL , p = 0.0011 ) , and 120-minute PPG ( −23.0 mg/dL , p = 0.0016 ) at 24 weeks . Treatment with saxagliptin result ed in similar reductions in HBA1c relative to placebo , irrespective of metformin treatment . At 24 weeks , difference in adjusted mean fasting plasma glucose for saxagliptin versus placebo was −4.02 mg/dL ( p = 0.3958 ) ; 17.3 % and 6.7 % of patients in the saxagliptin and placebo groups , respectively , achieved HbA1c < 7 % . Mean change from baseline in body weight at week 24 was 0.39 kg for saxagliptin and 0.18 kg for placebo . Hypoglycemia was reported in 18.4 % and 19.9 % of patients in the saxagliptin and placebo groups , respectively ( confirmed hypoglycemia : 5.3 % , 3.3 % ) . Other adverse events reported in at least 5 % of patients were urinary tract infection ( saxagliptin , placebo : 5.9 % , 6.0 % ) , influenza ( 3.0 % , 6.6 % ) , and pain in extremity ( 1.6 % , 6.0 % ) . Conclusions : Saxagliptin 5-mg once-daily add-on therapy improves glycemic control in T2D patients on insulin alone or combined with metformin and is generally well-tolerated . |
1,375 | 27,352,922 | The MMAS-8 ( Morisky Medication Adherence Scale–8 items ) and the Hill-Bone scale were the most frequently used instruments .
They were found to be well vali date d , with strong evidence for internal consistency and strong positive evidence for reliability , structural validity , hypothesis testing , and criterion validity .
Conclusions The MMAS-8 and Hill-Bone scale seem to be well-vali date d instruments for assessing medication adherence in adults at risk for metabolic syndrome . | Purpose The purpose of this study was to present a systematic review of available published studies that evaluated the measurement properties of self-reported instruments assessing global medication adherence in adults at risk for metabolic syndrome . | OBJECTIVE : To review the literature on strategies to optimize medication adherence in community-dwelling older adults and to make recommendations for clinical practice . METHODS : A systematic literature search was conducted using the MEDLINE , CINAHL , PsycINFO , International Pharmaceutical Abstract s , and EMBASE data bases for r and omized controlled trials examining strategies to optimize medication adherence in patients aged 65 or older prescribed long-term medication regimens . Additional studies were found by examining the reference lists of systematic review s and selected papers . 34 papers reporting on 33 studies met the eligibility criteria and were included in this review . RESULTS : Improvement in adherence was mixed across the studies examining educational interventions , with only 12 of the 28 studies showing improvement in adherence ; most were delivered by pharmacists . Effect sizes for the statistically significant educational interventions ranged from Cohen 's d = 0.14 to 4.93 . Four of the 5 interventions using memory aids and cues , some in conjunction with newer technologies , improved adherence . Effect sizes for the statistically significant interventions using memory aids and cues ranged from Cohen 's d = 0.26 to 2.72 . CONCLUSION : The evidence from this review does not clearly support one single intervention to optimize medication adherence in older patients . Future studies should explore suggestive strategies , such as tailored interventions involving ongoing contact , and should endeavor to correct method ologic weaknesses found in the literature Objective This study examined the psychometric properties of the Korean version of the eight-item Morisky Medication Adherence Scale ( MMAS-8 ) to measure adherence to diabetes medication in patients with type 2 diabetes mellitus . Methods The English version of the MMAS-8 was translated into Korean and administered to patient with type 2 diabetes mellitus via face-to-face interviews , conducted by an independent interviewer . Patient characteristics and glycosylated haemoglobin ( HbA1c ) levels were assessed at the same clinic visit . A proportion of patients was r and omly selected for 2-week test-retest reliability via telephone interviews . Convergent validity of the MMAS-8 against a four-item MMAS , correlations with HbA1c levels and construct validity of the MMAS-8 were evaluated . Results In total , 317 patients were included ; 70 completed the 2-week test – retest interview . Internal consistency reliability was moderate and test – retest reliability of the MMAS-8 was excellent , although a ceiling effect was detected . Good convergent validity was shown by the high correlation of the new scale scores with the original MMAS-4 . A significant association was found between MMAS-8 scores and HbA1c levels . Using glycaemic control as a gold st and ard , sensitivity was 74.1 % and specificity was 38.3 % . Explanatory factor analysis identified three dimensions of the scale . Conclusions In light of acceptable reliability and validity , the MMAS-8 is a simple and quick method for the assessment of medication adherence among patient with type 2 diabetes mellitus , in a busy clinic setting Background The clinical benefits of any new treatment depend substantially on patient acceptance and treatment satisfaction , because only well-accepted treatments will be widely used . Thus , it is important to underst and how patients experience a new treatment . Objective This study assessed the psychometric properties of a question naire ( PRAM-TSQ ) design ed to measure treatment satisfaction in patients using pramlintide ( an analog of amylin , a glucoregulatory hormone co-secreted with insulin ) , which is design ed to improve glucose control . Methods Patients with diabetes completed the 14-item PRAM-TSQ at the end of 2 separate placebo-controlled , double-blind , r and omized clinical trials in which they added active or placebo pramlintide to their established insulin regimen . Factor analysis was used to assess item clustering for the PRAM-TSQ , and the Cronbach 's α measure of inter-item agreement was used to assess scale reliability . PRAM-TSQ validity was assessed by comparing scores between treatment arms , and effect sizes were measured by the η statistic . Validity was also assessed by associations ( Pearson correlations ) between the PRAM-TSQ and clinical study outcomes ( end of study values and during study changes in clinical measures : postpr and ial glucose [ PPG ] , A1C , weight , and insulin requirements ) . Results Scaling revealed 4 PRAM-TSQ components : Global Benefits , Specific Benefits , Absence of Side Effects , Treatment Preference . The total composite PRAM-TSQ had good reliability in both studies ( type 1 α = .93 ; type 2 α = .94 ) ; subscale reliabilities ranged from .65 to 94 . Composite scores differed for pramlintide-treated and placebo-treated patients ( type 1 P < .01 ; type 2 P < .05 ) , and were associated with lower PPG , weight , and insulin requirements ( all P < .05 ) . Results were similar for PRAM-TSQ subscales assessing Global Benefits and Treatment Preference ; Specific Benefits subscale scores were associated with lower PPG and weight ( all P < .05 ) . Conclusions The PRAM-TSQ shows evidence of being a valid , reliable instrument for assessing treatment satisfaction in patients using pramlintide . The subscales are comprehensive and sensitive to the known potential effects of pramlintide treatment . Diabetes educators can use patient responses to the PRAM-TSQ to facilitate treatment adherence by reminding patients of treatment benefits they experience and by helping patients overcome negative effects they report Background We examined the psychometric properties of the Korean version of the 8-item Morisky Medication Adherence Scale ( MMAS-8 ) among adults with hypertension . Methods A total of 373 adults with hypertension were given face-to-face interviews in 2 cardiology clinics at 2 large teaching hospitals in Seoul , South Korea . Blood pressure was measured twice , and medical records were review ed . About one-third of the participants ( n = 109 ) were r and omly selected for a 2-week test-retest evaluation of reliability via telephone interview . Results Internal consistency reliability was moderate ( Cronbach α = 0.56 ) , and test-retest reliability was excellent ( intraclass correlation = 0.91 ; P < 0.001 ) , although a ceiling effect was detected . The correlation of MMAS-8 scores with scores for the original 4-item scale indicated that convergent validity was good ( r = 0.92 ; P < 0.01 ) . A low MMAS-8 score was significantly associated with poor blood pressure control ( χ2 = 29.86 ; P < 0.001 ; adjusted odds ratio = 5.08 ; 95 % CI , 2.56–10.08 ) . Using a cut-off point of 6 , sensitivity and specificity were 64.3 % and 72.9 % , respectively . Exploratory factor analysis identified 3 dimensions of the scale , with poor fit for the 1-dimensional construct using confirmatory factory analysis . Conclusions The MMAS-8 had satisfactory reliability and validity and thus might be suitable for assessment and counseling regarding medication adherence among adults with hypertension in a busy clinical setting in Korea Background : The ASK-20 survey is a previously vali date d patient-report measure of barriers to medication adherence and adherence-related behavior . Objective : To derive and vali date a shorter version of the ASK-20 scale . Methods : Patients with asthma , diabetes , and congestive heart failure were recruited from a university medical center . Participants completed the ASK-20 survey and other question naires . Approximately one-third of participants were r and omized to a 2-week retest administration . Item performance and results of an exploratory factor analysis were examined for item reduction and subscale identification . Subsequent analyses examined reliability and validity of the shorter version of the ASK . Results : A total of 112 patients participated ( 75.9 % female ; mean age 46.7 y ; 53.6 % African American ) . Eight items were dropped from the ASK-20 based on factor loadings , floor effects , Cronbach 's α , and the ability of each item to discriminate between groups of patients differing in self-reported adherence . The new total score ( ASK-12 ) had good internal consistency reliability ( Cronbach 's α 0.75 ) and test-retest reliability ( intraclass correlation 0.79 ) . Convergent validity was demonstrated through correlations with the Morisky Medication Adherence Scale ( r -0.74 ; p < 0.001 ) , condition-specific measures , the SF-12 Mental Component Score ( r –.32 ; p < 0.01 ) , and proportion of days covered by tilled medication prescriptions in the past 6 months as indicated by pharmacy cl aims data ( r -0.20 ; p = 0.059 ) . The ASK-12 total score also discriminated among groups of patients who differed in self-reported adherence indicators , including whether a dose was missed in the past week , the number of days medication was not taken as directed , and treatment satisfaction . Three subscales were identified ( adherence behavior , health beliefs , inconvenience/forgetfulness ) , and results provided initial support for their validity . Conclusions : The ASK-12 demonstrated adequate reliability and validity , and it may be a useful brief measure of adherence behavior and barriers to treatment adherence The Hill-Bone Compliance to High Blood Pressure Therapy Scale assesses patient behaviors for three important behavioral domains of high blood pressure treatment : 1 ) reduced sodium intake ; 2 ) appointment keeping ; and 3 ) medication taking . This scale is comprised of 14 items in three subscales . Each item is a four point Likert type scale . The content validity of the scale was assessed by a relevant literature review and an expert panel , which focused on cultural sensitivity and appropriateness of the instrument for low literacy . Internal consistency reliability and predictive validity of the scale were evaluated using two community based sample s of hypertensive adults enrolled in clinical trials of high blood pressure care and control . The st and ardized alpha for the total scale were 0.74 and 0.84 , and the average interitem correlations of the 14 items were 0.18 and 0.28 , respectively . The construct and predictive validity of the scale was assessed by factor analysis and by testing of theoretically derived hypotheses regarding whether the scale demonstrated consistent and expected relationships with related variables . In this study , high compliance scale scores predicted significantly lower levels of blood pressure and blood pressure control . Moreover , high compliance scale scores at the baseline were significantly associated with blood pressure control at both baseline and at follow up in the two independent sample s. This brief instrument provides a simple method for clinicians in various setting s to use to assess patients ' self reported compliance levels and to plan appropriate interventions Background : Patient self-report is a practical method for measuring adherence , but little is known about its optimal use . Objectives : To examine the retest reliability and predictive validity of 3 different types of self-report adherence measures among patients with common chronic illnesses . Research Design : Correlation and regression analyses of data from an ongoing r and omized controlled trial . Subjects : Patients ( N = 415 ) aged ≥40 years recruited from a primary care network with arthritis , asthma , chronic lung disease , congestive heart failure , depression , and /or diabetes mellitus , plus impairment in ≥1 basic activity and /or a score of ≥4 on the 10-item Center for Epidemiologic Studies Depression Scale . Measures : Self-report adherence ( administered variously at baseline , 2 , 4 , and 6 weeks , and 6 months ) : number of pills taken/number of pills prescribed ( PT/PP ) , using 1–7 days recall , and global reports of medication adherence and overall adherence tendencies . Six-month functional outcomes : Health Assessment Question naire ( HAQ ) and Short Form-36 ( SF-36 ) . Results : Correlation coefficients among contemporaneously administered 1–7 days PT/PP measures were ≥0.78 . Correlations among PT/PP measures and global adherence measures , and among PT/PP measures at 2 and 4 weeks , ranged from 0.11 to 0.54 . PT/PP measures using ≥3–4 days recall significantly predicted adjusted 6-month HAQ but not SF-36 score . Conclusions : Self-report PT/PP and general medication adherence measures tap different behavioral constructs . Self-reported PT/PP at a given point in time is not necessarily representative of medication adherence over time . Among chronically ill patients , 3–4 days recall of PT/PP yield adherence estimates , which are practically as reliable and valid as longer intervals and which predict functional outcomes |
1,376 | 30,694,383 | Prosthesis-related complications like fractures and subsidence and general complications like lung complications were more in uncemented group .
Mortality at 1 year was more in cemented group .
Secondary outcomes Mean surgical time was lesser in uncemented cases .
There was no difference in blood loss and re-operation rates .
Conclusion Cementing techniques are here to stay , until a better , durable and more stable uncemented stem evolves , that could lessen the complications related to uncemented surgeries and match the cemented implants in pain relief and ambulation | Background Management of fractures of neck of femur in the elderly is largely joint sacrificing , with hemiarthroplasties being the most common entity used .
Cemented and uncemented , both the techniques , are universally accepted ; however , the former has been more time tested , despite its theoretical disadvantage in the form of cement embolism leading to intra-operative complications .
Uncemented stems have been ever evolving with newer design s to increase incorporation , stability and durability .
They have their own reported sets of disadvantages like subsidence and fractures .
However , overall there is no established gold st and ard out of the two .
Objective The present systematic review and meta- analysis of current literature was conducted , so as to determine the superiority of one technique over the other by comparing the primary outcomes like hip function , residual pain , local and general complications and mortality . | Background It is unclear whether cemented or uncemented hemiarthroplasty is the best treatment option in elderly patients with displaced femoral neck fractures . Previous r and omized trials comparing cemented and uncemented hemiarthroplasty have conflicting results . We conducted a r and omized controlled trial to compare cemented and uncemented hemiarthroplasty . Methods This multicenter parallel-r and omized controlled trial included patients of 70 years and older with a displaced femoral neck fracture ( Garden type III or IV ) . Inclusion was between August 2008 and June 2012 . Patients were r and omized between a cemented hemiarthroplasty , type Müller Straight Stem or an uncemented hemiarthroplasty , type DB-10 . Primary outcomes were complications , operation time , functional outcome ( measured by Timed-Up- and -Go ( TUG ) and Groningen Activity Restriction Scale ( GARS ) ) and mid-thigh pain . Health Related Quality of Life ( HRQoL , expressed with the SF-12 ) was measured as an secondary outcome . Follow up was 1 year . Results In total 201 patients were included in the study ( 91 uncemented , 110 cemented hemiarthroplasties ) The uncemented group showed more major local complications ( intra- and postoperative fractures and dislocations ) odds ratio ( 95 % confidence interval ) 3.36 ( 1.40 to 8.11 ) . There was no difference in mean operation time ( 57.3 vs 55.4 min ) . There were no differences in functional outcomes ( TUG 12.8 ( 9.4 ) vs. 13.9 ( 9.0 ) , GARS 43.2 ( 19.7 ) vs. 39.2 ( 16.5 ) ) and mid-thigh pain ( 18.6 vs 21.6 % ) . Physical component SF-12 HRQoLwas lower in the uncemented group ( 30.3 vs. 35.3 p < 0.05 after six weeks , 33.8 vs 38.5 p < 0.05 after 12 weeks ) . Conclusion A cemented hemiarthroplasty in elderly patients with a displaced femoral neck fracture results in less complications compared to an uncemented hemiarthroplasty . Trial registration Netherl and s Trial Registry ; NTR 1508 , accepted date 27 okt Objective : To prospect ively compare the functional outcome associated with cemented and uncemented hemiarthroplasty . Design : Prospect i ve r and omized control trial . Setting : University-affiliated level 1 trauma center . Patients / Participants : All individuals design ated for hemiarthroplasty , older than 55 years , with a nonpathologic displaced femoral neck fracture and the ability to ambulate 10 feet independently before injury [ 269 patients ( 274 hips ) presented with displaced femoral neck fracture , 130 patients ( 48.3 % ) enrolled , and 5 patients ( 3.8 % ) withdrew ] . Intervention : Hip hemiarthroplasty with a cemented femoral prosthesis ( VerSys LD/Fx ; Zimmer , Warsaw , IN ) or an uncemented component ( VerSys Beaded FullCoat ; Zimmer , Warsaw , IN ) . Main Outcome Measures : Instrumental Activities of Daily Living and Physical Activities of Daily Living scales ( Older Americans Re sources and Services Instrument ) and the Energy/Fatigue Scale . Results : No statistically significant differences were present in the groups ' preoperative or intraoperative characteristics , including American Society of Anesthesiologists grade , operative time , anesthesia time , use of perioperative & bgr;-blockers , estimated blood loss , or the rate of intraoperative fracture . Postoperatively , no difference was found in hemoglobin level , transfusion rate , discharge disposition , or acute complication rate . At 30-day , 60-day , and 1-year follow-ups , no clinical ly or statistically significant differences were found in mortality , disposition , need for assistance with ambulation , Older Americans Re sources and Services Activities of Daily Living subscales , or the Energy/Fatigue Scale . Conclusions : In the treatment of nonpathologic displaced femoral neck fractures , the use of cemented and uncemented femoral components is associated with similar functional outcome at 1 year . Practitioners may inform their clinical decisions using these equally good results . Level of Evidence : Therapeutic Level II . See page 128 for a complete description of levels of evidence Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by three orthopaedic surgeons . Sixty patients ( 56 % ) had died in the cemented group and 63 ( 60 % ) in the uncemented group . Respectively , three and two patients ( 2.7 % and 1.9 % ) were completely lost to followup . Results Harris hip scores at 5 years were higher in the uncemented group than in the cemented group ( 86.2 versus 76.3 ; mean difference 9.9 ; 95 % confidence interval [ CI ] , 1.9–17.9 ) . The prevalence of postoperative periprosthetic femoral fractures was 7.4 % in the uncemented group and 0.9 % in the cemented group ( hazard ratio [ HR ] , 9.3 ; 95 % CI , 1.16–74.5 ) . Barthel Index and EQ-5D scores were not different between the groups . Between 1 and 5 years , we found no additional infections or dislocations . The mortality rate was not different between the groups ( HR , 1.2 ; 95 % CI , 0.82–1.7 ) . Conclusions Both arthroplasties may be used with good medium-term results after displaced femoral neck fractures . The uncemented hemiarthroplasty may result in higher hip scores but appears to carry an unacceptably high risk of later femoral fractures . Level of Evidence Level I , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence Objective To compare the functional results after displaced fractures of the femoral neck treated with internal fixation or hemiarthroplasty . Design R and omised trial with blinding of assessment s of functional results . Setting University hospital . Participants 222 patients ; 165 ( 74 % ) women , mean age 83 years . Inclusion criteria were age above 60 , ability to walk before the fracture , and no major hip pathology , regardless of cognitive function . Interventions Closed reduction and two parallel screws ( 112 patients ) and bipolar cemented hemiarthroplasty ( 110 patients ) . Follow-up at 4 , 12 , and 24 months . Main outcome measures Hip function ( Harris hip score ) , health related quality of life ( Eq-5d ) , activities of daily living ( Barthel index ) . In all cases high scores indicate better function . Results Mean Harris hip score in the hemiarthroplasty group was 8.2 points higher ( 95 % confidence interval 2.8 to 13.5 points , P=0.003 ) at four months and 6.7 points ( 1.5 to 11.9 points , P=0.01 ) higher at 12 months . Mean Eq-5d index score at 24 months was 0.13 higher in the hemiarthroplasty group ( 0.01 to 0.25 , P=0.03 ) . The Eq-5d visual analogue scale was 8.7 points higher in the hemiarthroplasty group after 4 months ( 1.9 to 15.6 , P=0.01 ) . After 12 and 24 months the percentage scoring 95 or 100 on the Barthel index was higher in the hemiarthroplasty group ( relative risk 0.67 , 0.47 to 0.95 , P=0.02 . and 0.63 , 0.42 to 0.94 , P=0.02 , respectively ) . Complications occurred in 56 ( 50 % ) patients in the internal fixation group and 16 ( 15 % ) in the hemiarthroplasty group ( 3.44 , 2.11 to 5.60 , P<0.001 ) . In each group 39 patients ( 35 % ) died within 24 months ( 0.98 , 0.69 to 1.40 , P=0.92 ) Conclusions Hemiarthroplasty is associated with better functional outcome than internal fixation in treatment of displaced fractures of the femoral neck in elderly patients . Trial registration NCT00464230 BACKGROUND Controversy exists regarding the use of cement for hemiarthroplasty to treat a displaced subcapital femoral neck fracture in elderly patients . The primary hypothesis of this study was that use of cement would provide better visual analog pain scores following this procedure in an elderly patient population . METHODS Elderly patients ( at least seventy years of age ) without severe cardiopulmonary compromise who presented to one institution with a displaced subcapital femoral neck fracture were offered inclusion in the study . One hundred and sixty patients ( mean age , eighty-five years ) with an acute displaced femoral neck fracture were r and omly allocated to hemiarthroplasty with either a cemented Exeter or an uncemented Zweymüller Alloclassic component . Clinical and radiographic follow-up was performed for two years and the outcomes were recorded by a blinded assessor . The main clinical outcome measures were pain , mortality , mobility , complications , reoperations , and quality of life measured with use of vali date d instruments . RESULTS The mean visual analog pain score at rest did not differ significantly between the groups . The total number of complications was greater in the uncemented group ( sixty-three compared with twenty-eight in the cemented group ) . Subsidence was significantly more common in the uncemented group ( eighteen compared with one in the cemented group ) . Intraoperative or postoperative fracture was also significantly more common in the uncemented group ( eighteen compared with one in the cemented group ) . The mortality rate did not differ significantly between the groups at any time point ( thirty-five deaths in the uncemented group compared with thirty-two in the cemented group at two years ) . The Oxford hip score was significantly poorer in the uncemented group at six weeks ( 38.8 compared with 35.7 in the cemented group ) , and it was also poorer or similar at later follow-up time points although the differences were not significant . There was also a trend toward poorer mobility and greater dependence on walking aids in the cemented group . The postoperative Short Musculoskeletal Function Assessment and Mini-Mental State Examination scores did not differ significantly between the groups . CONCLUSIONS In elderly patients ( seventy years or older ) without severe cardiopulmonary compromise who were treated with hemiarthroplasty for a displaced femoral neck fracture , use of a cemented Exeter implant and use of an uncemented Alloclassic implant provided a comparable outcome with regard to pain . However , implant-related complication rates were significantly lower in the group treated with a cemented implant . Trends toward better function and better mobility in the cemented group were observed . These trends reached significance in particular functional scores at some postoperative time points . LEVEL OF EVIDENCE Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence In a prospect i ve , controlled study , we measured the effect on cardiac output of the introduction of methylmethacrylate during hemiarthroplasty for displaced fractures of the femoral neck . We treated 20 elderly patients who were similar in age , height , weight and preoperative left ventricular function with either cemented or uncemented hemiarthroplasty . Using a transoesophageal Doppler probe , we measured cardiac output before incision and at six stages of the procedure : during the surgical approach , reaming and lavage of the femoral canal , the introduction of cement , the insertion of the prosthesis , and in reduction and closure . We found that before the cement was introduced , there was no difference in stroke volume or cardiac output ( p > 0.25 ) . Cementation produced a transient but significant reduction in cardiac output of 33 % ( p < 0.01 ) and a reduction in stroke volume of 44 % ( p < 0.02 ) . The introduction of cement did not affect the heart rate or mean arterial pressure . There was no significant difference in cardiac function on insertion of the prosthesis . St and ard non-invasive haemodynamic monitoring did not detect the cardiovascular changes which may account for the sudden deaths that sometimes occur during cemented hemiarthroplasty . The fall in stroke volume and cardiac output may be caused by embolism occurring during cementation , but there was no similar fall during reaming or insertion of the prosthesis We performed transoesophageal echocardiography on 20 patients with femoral neck fractures r and omly treated with an uncemented Austin-Moore or cemented Hastings hemiarthroplasty . Cemented arthroplasty caused greater and more prolonged embolic cascades than did uncemented arthroplasty . Some emboli were more than 3 cm in length . In some patients the cascades were associated with pulmonary hypertension , diminished oxygen tension and saturation , and the presence of fat and marrow in aspirates from the right atrium |
1,377 | 31,598,914 | This systematic review and meta- analysis showed that ( 1 ) organization-directed interventions were associated with moderate reduction in burnout score , ( 2 ) physician-directed interventions were associated with small reduction in burnout score , ( 3 ) organization-directed interventions reduced more the depersonalization than physician-directed interventions , ( 4 ) organization-directed interventions were related to a more improvement of the personal accomplishment than physician-directed interventions .
This meta analysis found that physicians could gain important benefits from interventions to reduce burnout , especially from organizational strategies , by viewing burnout rooted in issues related to the working environment and organizational culture | The growing “ process ” of burnout impair performance and quality of professional services , with consequences for physicians , healthcare care organization , and patient ’s outcomes .
We aim to evaluate which strategy of intervention , individual or organization directed , is more effective to reduce physician burnout and to provide management suggestions in terms of actual organizational strategies and intensity leading to reductions in physician burnout . | OBJECTIVE To prospect ively study the effects of an incentivized exercise program on physical activity ( PA ) , quality of life ( QOL ) , and burnout among residents and fellows ( RFs ) in a large academic medical center . PARTICIPANTS AND METHODS In January 2011 , all RFs at Mayo Clinic in Rochester , Minnesota ( N=1060 ) , were invited to participate in an elective , team-based , 12-week , incentivized exercise program . Both participants and non participants had access to the same institutional exercise facilities . Regardless of participation , all RFs were invited to complete baseline and follow-up ( 3-month ) assessment s of PA , QOL , and burnout . RESULTS Of the 628 RFs who completed the baseline survey ( 59 % ) , only 194 ( 31 % ) met the US Department of Health and Human Services recommendations for PA . Median reported QOL was 70 on a scale of 1 to 100 , and 182 ( 29 % ) reported at least weekly burnout symptoms . A total of 245 individuals ( 23 % ) enrolled in the exercise program . No significant differences were found between program participants and non participants with regard to baseline demographic characteristics , medical training level , PA , QOL , or burnout . At study completion , program participants were more likely than non participants to meet the Department of Health and Human Services recommendations for exercise ( 48 % vs 23 % ; P<.001 ) . Quality of life was higher in program participants than in non participants ( median , 75 vs 68 ; P<.001 ) . Burnout was lower in participants than in non participants , although the difference was not statistically significant ( 24 % vs 29 % ; P=.17 ) . CONCLUSION A team-based , incentivized exercise program engaged 23 % of RFs at our institution . After the program , participants had higher PA and QOL than non participants who had equal exercise facility access . Residents and fellows may be much more sedentary than previously reported BACKGROUND Informed consent is required for both st and ard cancer treatments and experimental cancer treatments in a clinical trial . Effective and sensitive physician-patient communication about informed consent is difficult to achieve . Our aim was to train doctors in clear , collaborative and ethical communication about informed consent and evaluate the impact of training on doctor behaviour , stress and satisfaction . PARTICIPANTS AND METHODS Participants were 21 oncologists from 10 Australian/New Zeal and ( ANZ ) centres and 41 oncologists from 10 Swiss/German/Austrian ( SGA ) centres . Oncologists were r and omized to participate in a 1-day workshop or not . Patients were recruited before and after the training . Doctors were asked to su bmi t 1 - 2 audiotaped consultations before and after training . Doctors completed outcome measures before and after completing the post-training cohort recruitment . RESULTS Ninety-five consultation interactions were audiotaped . Doctors strongly endorsed the training . ANZ intervention doctors demonstrated a significant increase in collaborative communication ( P = 0.03 ) . There was no effect of training on other doctor behaviours . Trained doctors did not demonstrate reduced stress and burnout . Patient outcomes are presented elsewhere . CONCLUSIONS Training can improve some aspects of the process of obtaining informed consent . Methods to increase the impact of training are required and may include longer training and more intensive follow-up OBJECTIVES To estimate burnout prevalence among pediatric residents and to evaluate the impact of a brief intervention aim ed at controlling burnout . METHODS A r and omized controlled trial was conducted on 74 pediatric residents . The Maslach Burnout Inventory was administered to all subjects , and demographic information was gathered ( age , gender , children , cohabitants , and residency year ) . The experimental group ( n = 37 ) participated in self-care workshops over the course of 2 months , and the control group ( n = 37 ) did not receive any intervention . After the intervention , the Maslach Burnout Inventory was administered again to all participants . All potential predictors of burnout were included in a logistic regression model . The efficacy of the intervention was evaluated by the chi-square test . P values < 0.05 were considered significant . RESULTS The burnout prevalence among pediatric residents was 66 % . After controlling for age , gender , children , and cohabitants , the prevalence of burnout was significantly higher among third-year residents ( odds ratio = 11.8 ; 95 % confidence interval 2.3 - 59.3 ; p = 0.003 ) . There were no significant differences regarding burnout prevalence in the experimental group between the baseline and post-intervention periods ( p = 0.8 ) or between the two groups after intervention ( p = 0.8 ) . The only difference observed was an improvement regarding " depersonalization " in the experimental group ( p = 0.031 ) . CONCLUSIONS The burnout prevalence among pediatric residents was 66 % and was higher among third-year residents . A brief intervention was not effective in reducing burnout prevalence , despite the achievement of an improvement in " depersonalization . CONTEXT Data are sparse on the effect of varying the duration s of internal medicine attending physician ward rotations . OBJECTIVE To compare the effects of 2- vs 4-week inpatient attending physician rotations on unplanned patient revisits , attending evaluations by trainees , and attending propensity for burnout . DESIGN , SETTING , AND PARTICIPANTS Cluster r and omized crossover noninferiority trial , with attending physicians as the unit of crossover r and omization and 4-week rotations as the active control , conducted in a US university-affiliated teaching hospital in academic year 2009 . Participants were 62 attending physicians who staffed at least 6 weeks of inpatient service , the 8892 unique patients whom they discharged , and the 147 house staff and 229 medical students who evaluated their performance . INTERVENTION Assignment to r and om sequences of 2- and 4-week rotations . MAIN OUTCOME MEASURES Primary outcome was 30-day unplanned revisits ( visits to the hospital 's emergency department or urgent ambulatory clinic , unplanned readmissions , and direct transfers from neighboring hospitals ) for patients discharged from 2- vs 4-week within-attending-physician rotations . Noninferiority margin was a 2 % increase ( odds ratio [ OR ] of 1.13 ) in 30-day unplanned patient revisits . Secondary outcomes were length of stay ; trainee evaluations of attending physicians ; and attending physician reports of burnout , stress , and workplace control . RESULTS Among the 8892 patients , there were 2437 unplanned revisits . The percentage of 30-day unplanned revisits for patients of attending physicians on 2-week rotations was 21.2 % compared with 21.5 % for 4-week rotations ( mean difference , -0.3 % ; 95 % CI , -1.8 % to + 1.2 % ) . The adjusted OR of a patient having a 30-day unplanned revisit after 2- vs 4-week rotations was 0.97 ( 1-sided 97.5 % upper confidence limit , 1.07 ; noninferiority P = .007 ) . Average length of stay was not significantly different ( geometric means for 2- vs 4-week rotations were 67.2 vs 67.5 hours ; difference , -0.9 % ; 95 % CI , -4.7 % to + 2.9 % ) . Attending physicians were more likely to score lower in their ability to evaluate trainees after 2- vs 4-week rotations by both house staff ( 41 % vs 28 % rated less than perfect ; adjusted OR , 2.10 ; 95 % CI , 1.50 - 3.02 ) and medical students ( 82 % vs 69 % rated less than perfect ; adjusted OR , 1.41 ; 95 % CI , 1.06 - 2.10 ) . They were less likely to report higher scores of both burnout severity ( 16 % vs 35 % ; adjusted OR , 0.39 ; 95 % CI , 0.26 - 0.58 ) and emotional exhaustion ( 19 % vs 37 % ; adjusted OR , 0.45 ; 95 % CI , 0.31 to 0.64 ) after 2- vs 4-week rotations . CONCLUSIONS The use of 2-week inpatient attending physician rotations compared with 4-week rotations did not result in an increase in unplanned patient revisits . It was associated with better self-rated measures of attending physician burnout and emotional exhaustion but worse evaluations by trainees . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00930111 Background : Shorter resident duty periods are increasingly m and ated to improve patient safety and physician well-being . However , increases in continuity-related errors may counteract the purported benefits of reducing fatigue . We evaluated the effects of 3 resident schedules in the intensive care unit ( ICU ) on patient safety , resident well-being and continuity of care . Methods : Residents in 2 university-affiliated ICUs were r and omly assigned ( in 2-month rotation-blocks from January to June 2009 ) to in-house overnight schedules of 24 , 16 or 12 hours . The primary patient outcome was adverse events . The primary resident outcome was sleepiness , measured by the 7-point Stanford Sleepiness Scale . Secondary outcomes were patient deaths , preventable adverse events , and residents ’ physical symptoms and burnout . Continuity of care and perceptions of ICU staff were also assessed . Results : We evaluated 47 ( 96 % ) of 49 residents , all 971 admissions , 5894 patient-days and 452 staff surveys . We found no effect of schedule ( 24- , 16- or 12-h shifts ) on adverse events ( 81.3 , 76.3 and 78.2 events per 1000 patient-days , respectively ; p = 0.7 ) or on residents ’ sleepiness in the daytime ( mean rating 2.33 , 2.61 and 2.30 , respectively ; p = 0.3 ) or at night ( mean rating 3.06 , 2.73 and 2.42 , respectively ; p = 0.2 ) . Seven of 8 preventable adverse events occurred with the 12-hour schedule ( p = 0.1 ) . Mortality rates were similar for the 3 schedules . Residents ’ somatic symptoms were more severe and more frequent with the 24-hour schedule ( p = 0.04 ) ; however , burnout was similar across the groups . ICU staff rated residents ’ knowledge and decision-making worst with the 16-hour schedule . Interpretation : Our findings do not support the purported advantages of shorter duty schedules . They also highlight the trade-offs between residents ’ symptoms and multiple secondary measures of patient safety . Further delineation of this emerging signal is required before widespread system change . Trial registration : Clinical Trials.gov , no. NCT00679809 RATIONALE Around-the-clock intensivist presence in intensive care units ( ICUs ) has been promoted as necessary to optimize outcomes . Little data have addressed how it affects the multiple stakeholders in such care . OBJECTIVES To assess effects of around-the-clock intensivist presence on intensivists , patients , families , housestaff , and nurses . METHODS This 32-week , crossover pilot trial of two intensivist staffing models , performed in two Canadian ICUs , alternated 8-week blocks of two staffing models : the st and ard model , where one intensivist worked for 7 days , taking night call from home ; and the shift work model , where one intensivist worked 7 day shifts , while other intensivists remained in the ICU at night . MEASUREMENTS AND MAIN RESULTS Surveys scaled from 0 - 100 points assessed outcomes for 24 intensivists ( primary outcome : burnout ) ; 119 families ( satisfaction ) ; 74 nurses ( satisfaction with collaboration and communications , role conflict ) ; and 34 housestaff ( autonomy , supervision , and learning opportunities ) . Outcomes for 501 patients included mortality , length of stay , and re source use . Intensivists doing shift work experienced less burnout ( -6.9 points ; P = 0.04 ) . Adjusted hospital mortality ( odds ratio , 1.22 ; P = 0.44 ) , ICU length of stay ( -6 h ; P = 0.46 ) , and family satisfaction ( 0.9 points ; P = 0.79 ) did not differ between staffing models . Under shift work staffing , nurses reported more role conflict ( 9 points ; P < 0.001 ) , whereas nighttime housestaff reported less autonomy , more supervision , but no difference in learning opportunities . CONCLUSIONS Shiftwork staffing was better for intensivists and most were receptive once they had experienced it . Although there were no evident negative outcomes for patients or families , further evaluation is needed to clarify how around-the-clock intensivist staffing influences the various stakeholders in ICU care , given power considerations in this study . Clinical trial registered with www . clinical trials.gov ( NCT 01146691 ) Background Internship and residency are difficult times with novice practitioners facing new challenges and stressors . Junior doctors may experience burnout , a syndrome that encompasses three dimensions : emotional exhaustion , depersonalisation and reduced personal accomplishment . While there is some existing literature on the prevalence of burnout in junior doctors , there are few studies on interventional strategies . Aims This study aim ed to examine the prevalence of burnout in a cohort of junior doctors and whether debriefing sessions reduced levels of burnout . Methods A prospect i ve r and omised controlled study of a convenience sample of postgraduate year 1 doctors in a single hospital was undertaken during a rotation term in 2011 . All participants completed a question naire using a vali date d tool , the Maslach Burnout Inventory , to determine the prevalence of burnout . They were then r and omly assigned to a group who were to receive four debriefing sessions over 2 months , or , to the control group , who had no debriefing sessions . Quantitative and qualitative analyses were conducted . Results Thirty-one postgraduate year 1 doctors participated in the study , with 13 being assigned to the group receiving debriefing sessions and 18 assigned to the control group . At baseline , 21/31 ( 68 % ) participants displayed evidence of burnout in at least one domain as measured by the Maslach Burnout Inventory . Burnout was significantly higher in women . There was no significant difference in burnout scores with debriefing . The intervention was well received with 11/18 ( 61 % ) suggesting they would recommend the strategy to future junior doctors and 16/18 ( 89 % ) found that the sessions were a source of emotional and social support . Conclusions Burnout is prevalent among postgraduate year 1 doctors , and they value the emotional and social support from attending debriefing sessions . A larger study is required to determine if debriefing can reduce the incidence of burnout in junior doctors IMPORTANCE Despite the documented prevalence and clinical ramifications of physician distress , few rigorous studies have tested interventions to address the problem . OBJECTIVE To test the hypothesis that an intervention involving a facilitated physician small-group curriculum would result in improvement in well-being . DESIGN , SETTING , AND PARTICIPANTS R and omized clinical trial of 74 practicing physicians in the Department of Medicine at the Mayo Clinic in Rochester , Minnesota , conducted between September 2010 and June 2012 . Additional data were collected on 350 nontrial participants responding to annual surveys timed to coincide with the trial surveys . INTERVENTIONS The intervention involved 19 biweekly facilitated physician discussion groups incorporating elements of mindfulness , reflection , shared experience , and small-group learning for 9 months . Protected time ( 1 hour of paid time every other week ) for participants was provided by the institution . MAIN OUTCOMES AND MEASURES Meaning in work , empowerment and engagement in work , burnout , symptoms of depression , quality of life , and job satisfaction assessed using vali date d metrics . RESULTS Empowerment and engagement at work increased by 5.3 points in the intervention arm vs a 0.5-point decline in the control arm by 3 months after the study ( P = .04 ) , an improvement sustained at 12 months ( + 5.5 vs + 1.3 points ; P = .03 ) . Rates of high depersonalization at 3 months had decreased by 15.5 % in the intervention arm vs a 0.8 % increase in the control arm ( P = .004 ) . This difference was also sustained at 12 months ( 9.6 % vs 1.5 % decrease ; P = .02 ) . No statistically significant differences in stress , symptoms of depression , overall quality of life , or job satisfaction were seen . In additional comparisons including the nontrial physician cohort , the proportion of participants strongly agreeing that their work was meaningful increased 6.3 % in the study intervention arm but decreased 6.3 % in the study control arm and 13.4 % in the non study cohort ( P = .04 ) . Rates of depersonalization , emotional exhaustion , and overall burnout decreased substantially in the trial intervention arm , decreased slightly in the trial control arm , and increased in the nontrial cohort ( P = .03 , .007 , and .002 for each outcome , respectively ) . CONCLUSIONS AND RELEVANCE An intervention for physicians based on a facilitated small-group curriculum improved meaning and engagement in work and reduced depersonalization , with sustained results at 12 months after the study . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01159977 ABSTRACT BACKGROUND Work conditions in primary care are associated with physician burnout and lower quality of care . OBJECTIVE We aim ed to assess if improvements in work conditions improve clinician stress and burnout . SUBJECTS Primary care clinicians at 34 clinics in the upper Midwest and New York City participated in the study . STUDY DESIGN This was a cluster r and omized controlled trial . MEASURES Work conditions , such as time pressure , workplace chaos , and work control , as well as clinician outcomes , were measured at baseline and at 12–18 months . A brief worklife and work conditions summary measure was provided to staff and clinicians at intervention sites . INTERVENTIONS Diverse interventions were grouped into three categories : 1 ) improved communication ; 2 ) changes in workflow , and 3 ) targeted quality improvement ( QI ) projects . ANALYSIS Multilevel regressions assessed impact of worklife data and interventions on clinician outcomes . A multilevel analysis then looked at clinicians whose outcome scores improved and determined types of interventions associated with improvement . RESULTS Of 166 clinicians , 135 ( 81.3 % ) completed the study . While there was no group treatment effect of baseline data on clinician outcomes , more intervention clinicians showed improvements in burnout ( 21.8 % vs 7.1 % less burned out , p = 0.01 ) and satisfaction ( 23.1 % vs 10.0 % more satisfied , p = 0.04 ) . Burnout was more likely to improve with workflow interventions [ Odds Ratio ( OR ) of improvement in burnout 5.9 , p = 0.02 ] , and with targeted QI projects than in controls ( OR 4.8 , p = 0.02 ) . Interventions in communication or workflow led to greater improvements in clinician satisfaction ( OR 3.1 , p = 0.04 ) , and showed a trend toward greater improvement in intention to leave ( OR 4.2 , p = 0.06 ) . LIMITATIONS We used heterogeneous intervention types , and were uncertain how well interventions were instituted . CONCLUSIONS Organizations may be able to improve burnout , dissatisfaction and retention by addressing communication and workflow , and initiating QI projects targeting clinician concerns BACKGROUND Burnout is highly prevalent in GPs and can have a negative influence on their wellbeing , performance , and patient care . Mindfulness-based stress reduction ( MBSR ) may be an effective intervention to decrease burnout symptoms and increase wellbeing . AIM To gain insight into the feasibility and effectiveness of MBSR on burnout , empathy , and ( work-related ) wellbeing in GPs . DESIGN AND SETTING A mixed methods pilot study , including a waiting list-controlled pre-/post- study and a qualitative study of the experiences of participating GPs in the Netherl and s. METHOD Participants were sent question naires assessing burnout , work engagement , empathy , and mindfulness skills , before and at the end of the MBSR training/waiting period . Qualitative data on how GPs experienced the training were collected during a plenary session and with evaluation forms at the end of the course . RESULTS Fifty Dutch GPs participated in this study . The MBSR group reported a greater decrease in depersonalisation than the control group ( adjusted difference -1.42 , 95 % confidence interval [ CI ] = -2.72 to -0.21 , P = 0.03 ) . Dedication increased more significantly in the MBSR group than in the control group ( adjusted difference 2.17 , 95 % CI = 0.51 to 3.83 , P = 0.01 ) . Mindfulness skills increased significantly in the MBSR group compared with the control group ( adjusted difference 6.90 , 95 % CI = 1.42 to 12.37 , P = 0.01 ) . There was no significant change in empathy . The qualitative data indicated that the MBSR course increased their wellbeing and compassion towards themselves and others , including their patients . CONCLUSION The study shows that MBSR for GPs is feasible and might result in fewer burnout symptoms and increased work engagement and wellbeing . However , an adequately powered r and omised controlled trial is needed to confirm the study 's findings RATIONALE Little is known about the consequences of intensivists ’ work schedules , or intensivist continuity of care . OBJECTIVES To assess the impact of weekend respite for intensivists , with consequent reduction in continuity of care , on them and their patients . METHODS In five medical intensive care units ( ICUs ) in four academic hospitals we performed a prospect i ve , cluster-r and omized , alternating trial of two intensivist staffing schedules . Daily coverage by a single intensivist in half-month rotations ( continuous schedule ) was compared with weekday coverage by a single intensivist , with weekend cross-coverage by colleagues ( interrupted schedule ) . We studied consecutive patients admitted to study units , and the intensivists working in four of the participating units . MEASUREMENTS AND MAIN RESULTS The primary patient outcome was ICU length of stay (LOS);we also assessed hospital LOS and mortality rates . The primary intensivist outcome was physician burnout . Analysis was by multivariable regression . A total of 45 intensivists and 1,900 patients participated in the study . Continuity of care differed between schedules ( patients with multiple intensivists = 28 % under continuous schedule vs. 62 % under interrupted scheduling ; P < 0.0001 ) . LOS and mortality were nonsignificantly higher under continuous scheduling ( ΔICU LOS 0.36 d , P = 0.20 ; Δhospital LOS 0.34 d , P = 0.71 ; ICU mortality , odds ratio = 1.43 , P = 0.12 ; hospital mortality , odds ratio = 1.17,P = 0.41 ) . Intensivists experienced significantly higher burnout , work – home life imbalance , and job distress working under the continuous schedule . CONCLUSIONS Work schedules where intensivists received weekend breaks were better for the physicians and , despite lower continuity of intensivist care , did not worsen outcomes for medical ICU patients BACKGROUND Patient safety and sleep experts advocate a protected sleep period for residents . OBJECTIVE We examined whether interns scheduled for a protected sleep period during overnight call would have better end-of-rotation assessment s of burnout , depression , and empathy scores compared with interns without protected sleep periods and whether the amount of sleep obtained during on call predicted end-of-rotation assessment s. METHODS We conducted a r and omized , controlled trial with internal medicine interns at the Philadelphia Veterans Affairs Medical Center ( PVAMC ) and the Hospital of the University of Pennsylvania ( HUP ) in academic year 2009 - 2010 . Four-week blocks were r and omly assigned to either overnight call permitted under the 2003 duty hour st and ards or a protected sleep period from 12:30 am to 5:30 am . Participants wore wrist actigraphs . At the beginning and end of the rotations , they completed the Beck Depression Inventory ( BDI-II ) , Maslach Burnout Inventory ( MBI-HSS ) , and Interpersonal Reactivity Index ( IRI ) . RESULTS A total of 106 interns participated . There were no significant differences between groups in end-of-rotation BDI-II , MBI-HSS , or IRI scores at either location ( P > .05 ) . Amount of sleep while on call significantly predicted lower MBI-Emotional Exhaustion ( P < .003 ) , MBI-Depersonalization ( P < .003 ) , and IRI-Personal Distress ( P < .006 ) at PVAMC , and higher IRI-Perspective Taking ( P < .008 ) at HUP . CONCLUSIONS A protected sleep period produced few consistent improvements in depression , burnout , or empathy , although depression was already low at baseline . Possibly the amount of protected time was too small to affect these emotional states or sleep may not be directly related to these scores Introduction : This study aim ed to test the acceptability and effectiveness of a two-phase mindfulness-based stress reduction program ( 8-week initial treatment plus a 10-month maintenance phase ) in alleviating work stress-related symptoms ( i.e. , burnout , heart rate [ HR ] , and blood pressure [ BP ] ) in a sample of 42 physicians . Methods : A r and omized controlled trial and a simple pre-post design were used , respectively , for each of the two phases of the study . Outcome measures included the Five Facets of Mindfulness Question naire and the Maslach Burnout Question naire . HR and BP measures were also obtained in the experimental group by means of a digital monitor . Results : After the initial 8 weeks of treatment , significant improvements for the experimental group in mindfulness levels and reductions in emotional exhaustion , HR , and BP were obtained . Effect sizes ( Cohen d ) significantly increased over the 10-month maintenance period , especially for mindfulness and systolic BP . Acceptance was notably high ( low attrition rate and high compliance with program activities ) . Discussion : Outcomes are significant in terms of practical consequences for reducing and controlling risks of developing burnout and cardiovascular disease in this population and enhancing well-being in life Abstract Introduction : Stress and burnout are highly prevalent among medical doctors , and are associated with negative consequences for doctors , patients , and organizations . The purpose of the current study was to examine the effectiveness of a mindfulness training intervention in reducing stress and burnout among medical practitioners , by means of a R and omised Controlled Trial design . Methods : Participants were 44 intern doctors completing an emergency department rotation in a major Australian hospital . Participants were r and omly assigned to either an active control ( one hour extra break per week ) or the 10-week mindfulness training intervention . Measures of stress and burnout were taken pre- , mid- and post intervention . Results : Participants undergoing the 10-week mindfulness training program reported greater improvements in stress and burnout relative to participants in the control condition . Significant reduction in stress and burnout was observed for participants in the mindfulness condition . No such reductions were observed for participants in the control condition . Conclusions : Mindfulness interventions may provide medical practitioners with skills to effectively manage stress and burnout , thereby reducing their experience of these symptoms . It is likely that doctors would benefit from the inclusion of such a training program as a part of their general medical education Introduction : Burnout is a very prevalent type of stress among health professionals . It affects their well‐being , performance , and attitude toward patients . This study assessed the effectiveness of a training program for primary health care professionals design ed to reduce burnout and mood disturbance , increase empathy , and develop mindfulness . Methods : Pragmatic r and omized controlled trial with pre‐ and postintervention measurements of 68 primary health care professionals ( 43 in the intervention and 25 in the control group ) in Spain . The intervention consisted of presentations of clinical ly relevant topics , mindfulness‐based coping strategies , mindfulness practice , yoga , and group discussion s ( 8 sessions of 2.5 hours per week plus a 1‐day session of 8 hours ) . Outcome measures included the Maslach Burnout Inventory , Profile of Mood States , Jefferson Scale of Physician Empathy , Baer 's Five Facets Mindfulness Question naire , and a question naire on changes in personal habits and mindfulness practice . Measurements were performed at baseline and after 8 weeks . Results : The intervention group improved in the 4 scales measured . The magnitude of the change was large in total mood disturbance ( difference between groups ‐7.1 ; st and ardized effect‐size [ SES ] 1.15 ) and mindfulness ( difference between groups 11 ; SES 0.9 ) and moderate in the burnout ( difference between groups ‐7 ; SES 0.74 ) and empathy scales ( difference between groups 5.2 ; SES 0.71 ) . No significant differences were found in the control group . Discussion : Our study supports the use of mindfulness‐based programs as part of continuing professional education to reduce and prevent burnout , promote positive attitudes among health professionals , strengthen patient‐provider relationships , and enhance well‐being PURPOSE Psychological morbidity in cancer patients is common , but often undetected and untreated . We developed a communication skills training ( CST ) program targeting this issue , and evaluated its impact on doctor behaviour . PATIENTS AND METHODS Thirty of 35 oncologists from six teaching hospitals in six Australian cities , participated . The CST was a 1.5-day intensive face-to-face workshop incorporating presentation of principles , a DVD modelling ideal behaviour and role-play practice , followed by four 1.5 h monthly video-conferences incorporating role-play of doctor-generated scenarios . Doctors were r and omized to receive the CST or not . Simulated patient interviews were videotaped and coded at baseline , after CST and 6 months later . Doctors completed question naires assessing stress and burnout at the same time points . RESULTS Doctors in the intervention group displayed more creating environment and fewer blocking behaviours at both follow-ups ; however , these differences did not reach statistical significance . Intervention doctors valued the training highly , but did not report substantial reductions in stress and burnout . CONCLUSIONS This short training programme demonstrated a positive effect on aspects of doctor behaviour . Video-conferencing after a short training course may be an effective strategy for delivering CST This is a longitudinal r and omized controlled study investigating the efficacy of a communication and stress management skills training programme on medical residents ’ self-efficacy to communicate and to manage stress in interviews , stress to communicate in interviews , and burnout . Ninety-six medical residents participated . Results showed a statistically significant increase in self-efficacy and decrease in stress to communicate . No changes were noted in burnout . Results of this training may encourage its compulsory organization in the medical curriculum . Further research is required to examine whether a programme associating person-directed and organization-directed interventions could have an impact on residents ’ burnout |
1,378 | 20,556,765 | The results suggest a positive effect of human growth hormone on weight gain and energy absorption .
However , in the majority of trials , the effects are short-lived returning to baseline shortly after cessation of therapy .
To date , the evidence is inconclusive to recommend this therapy . | BACKGROUND There has been clinical enthusiasm for treating short bowel patients with human recombinant growth hormone and /or glutamine in hopes of reducing parenteral nutrition dependency .
It has been more than a decade since Byrne and colleagues reported enhanced absorption of nutrients , improved weight gain , and reduction in parenteral nutrition requirements with the administration of a combination of human growth hormone ( HGH ) and glutamine in patients with short bowel syndrome .
Other studies have reported inconsistent results .
OBJECTIVES The purpose of this systematic review was to evaluate the efficacy of growth hormone with or without glutamine supplementation for adult patients with short bowel syndrome . | Objective The effects of growth hormone ( GH ) on the luminal transport of amino acids and glucose by the human small intestine were investigated . Summary Background Data The anabolic effect of growth hormone administration is associated with nitrogen retention and an increase muscle strength , but the impact of growth hormone on nutrient uptake from the gut lumen has not been examined . Methods Twelve healthy patients received a daily subcutaneous dose of low-dose GH ( 0.1 mg/kg ) , high-dose GH ( 0.2 mg/kg ) , or no treatment ( controls ) for 3 days before surgery . At operation , ileum ( 8 patients ) or jejunum ( 4 patients ) was resected , and brush border membrane vesicles ( BBMVs ) were prepared by differential centrifugation . Vesicle purity was confirmed by a 16-fold enrichment of marker enzymes . The carrier-mediated transport of glutamine ( System B ) , leucine ( System L ) , alanine ( System B ) , arginine ( System y+ ) , MeAIB ( methyl α-aminoisobutyric acid [ System A ] ) , and glucose ( Na+-dependent glucose transporter ) by BBMVs was measured by a rapid mixing/filtration technique . Results Treatment with low-dose GH result ed in a statistically insignificant increase in amino acid transport rates in jejunal and ileal BBMVs . High-dose GH result ed in a generalized 20%- to 70%- stimulation of amino acid transport , whereas glucose transport was not affected . The effects of GH were similar in ileum and jejunum . Kinetic analysis of the transport of glutamine ( the most abundant amino acid in the body and the principal gut fuel ) and the essential amino acid leucine revealed that the increase in transport was caused by a 50 % increase in carrier Vmax , consistent with an increase in the number of functional carriers in the brush border membrane . Pooled analysis of transport velocities demonstrated that total rates of amino acid uptake from the gut lumen were increased significantly by 35 % in GH-treated patients . Conclusions The ability of GH to enhance amino acid uptake from the gut lumen provides energy and precursors for protein synthesis in the gut mucosa , as well as additional substrate for anabolism in other organs This study was design ed to determine whether alanyl glutamine-containing total parental nutrition ( TPN ) can restore the impaired adaptive process of the remaining intestine , observed with administration of conventional TPN , after massive small-bowel resection . Seventy-four male Sprague-Dawley rats weighing 250 g were r and omly divided into seven groups . Group I rats ( n = 10 ) were killed after overnight fasting . Group II animals ( n = 32 ) underwent massive small bowel resection ( 85 % ) with preservation of the first 15 cm of jejunum . Group III animals ( n = 32 ) were also su bmi tted to massive small-bowel resection with preservation of 15 cm of terminal ileum . Three different TPN solutions were prepared . Solution A was a conventional formulation that did not contain glutamine . Solution B contained 1.88 times the amino acid concentration of solution A. Solution C was prepared by adding alanyl glutamine ( 2 g/100 mL ) to solution A. Solutions B and C were isonitrogenous and isocaloric . Each solution was infused to groups II and III , which were subdivided into groups IIA ( n = 10 ) , IIB ( n = 11 ) , IIC ( n = 11 ) , IIIA ( n = 10 ) , IIIB ( n = 11 ) , and IIIC ( n = 11 ) . After 1 week of TPN ( 270 kcal/kg per day ) , the experimental animals were killed and the intestine was taken for examination . Final body weight did not differ significantly among the groups , and there was no difference in nitrogen balance among the animals that received solution B or C. ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND & AIMS The effects of parenteral growth hormone , glutamine supplementation , and a high carbohydrate-low fat ( HCLF ) diet on gut adaptation in short-bowel syndrome are unclear . The aim of this study was to compare effects of this treatment regimen and placebo in patients with short-bowel syndrome . METHODS A r and omized , 6-week , double-blind , placebo-controlled , crossover study in 8 patients with short-bowel syndrome ( average small bowel length , 71 cm ; mean duration , 12.9 years ) was performed . Active treatment was growth hormone ( 0.14 mg.kg-1.day-1 ) , oral glutamine ( 0.63 g.kg-1.day-1 ) , and the HCLF diet for 21 days . The weight , basal metabolic rate , nutrient and electrolyte balance , serum insulin-like growth factor I levels , D-xylose absorption , morphology and DNA proliferation of small intestinal mucosa , and gastrointestinal transit were evaluated . Treatments were compared by paired t test . RESULTS Active treatment transiently increased body weight , significantly but modestly increased the absorption of sodium and potassium , and decreased gastric emptying . The assimilation of macronutrients , stool volumes , and morphometry of small bowel mucosa were not statistically different in the two treatment arms . CONCLUSIONS Although treatment with growth hormone , glutamine , and HCLF diet for 3 weeks result ed in modest improvements in electrolyte absorption and delayed gastric emptying , there were no improvements in small bowel morphology , stool losses , or macronutrient absorption BACKGROUND A previous controlled study of ten patients with short bowel syndrome ( SBS ) reported human recombinant growth hormone result ed in a significant increase in body weight and lean body mass ( LBM ) without clinical edema . The aim of this study was to assess the effect of growth hormone , glutamine , and diet on body composition . METHODS A r and omized , 6-week , double-blind , placebo-controlled , crossover study was performed in eight patients . Active treatment was 21 days of growth hormone , oral glutamine , and a high-carbohydrate-low-fat ( HCLF ) diet . Body composition was determined by dual-energy x-ray absorptiometry ( DEXA ) scan . Treatments were compared by paired t test . RESULTS Active treatment result ed in significant increases in body weight ( mean 3.02 + /- 0.7 kg , p < .05 ) and lean body mass , ( mean 3.96 + /- 0.5 kg , p < .001 ) . Percent body fat was significantly reduced in the actively treated group ( mean -2.51 % + /- 0.4 , p < .001 ) . Body weight returned to base-line within 2 weeks of discontinuing active treatment . Macronutrient and fluid absorption did not increase with active treatment . CONCLUSIONS Treatment with growth hormone , glutamine , and HCLF diet result ed in decreased percent body fat and increased body weight and LBM in patients with SBS , without an increase in macronutrient or fluid absorption . The positive findings are most likely a reflection of increased extracellular fluid because all eight patients developed peripheral edema on active treatment . Furthermore , the positive effect of active treatment does not appear to be sustained once discontinued BACKGROUND Positive effects of high dose growth hormone and glutamine ( GH + GLN ) on body composition in short bowel patients have been described . Lack of effects on intestinal absorption found in some studies has been ascribed to concomitant essential fatty acid ( EFA ) deficiency . This study describes changes in body weight ( BW ) and composition , 24-h urine creatinine excretion , intestinal fatty acid absorption ( total , saturated , unsaturated and EFA ) , and EFA status in relation to treatment with GH + GLN in 8 short bowel patients . METHODS A double-blind , crossover study between placebo and growth hormone ( mean , 0.12 mg/kg/day ) plus oral ( mean , 28 g/day ) and parenteral glutamine ( mean , 5.2 g/day ) for 28 days . Body composition was measured by dual-energy absorptiometry ( DEXA ) scans . Intestinal fatty acid absorption was evaluated in balance studies , and EFAs were measured in plasma phospholipids by gas liquid chromatography . RESULTS Active treatment did not increase BW , lean body mass ( LBM ) , fat mass ( FM ) and bone mass significantly compared with placebo treatment , but BW increased 1.03 kg ( 1.7 % , P < 0.05 ) , LBM 2.93 kg ( 8.7 % , P < 0.001 ) and FM decreased 2.41 kg ( 10.6 % , P < 0.001 ) in comparison with baseline . Twenty-four-hour urine creatinine excretion did not differ between study periods . No changes in intestinal absorption of fatty acids were seen , and no changes in EFAs measured in plasma phospholipids were observed . Only 1 of 8 patients , who did not receive parenteral lipids , had a Holman index above 0.2 , indicative of EFA deficiency . All developed peripheral oedema . CONCLUSIONS Combined high dose growth hormone and glutamine administered for 4 weeks , did not improve absorption of fatty acids or EFA status in short bowel patients . No changes in BW or composition were seen when comparing treatment to placebo periods . The increase in LBM measured by DEXA scan , comparing treatment and baseline periods , was not accompanied by an increase in the 24-h urinary creatinine excretion and is suspected to be associated with an accumulation in extracellular fluids BACKGROUND Massive loss of intestinal surface area results in the short bowel syndrome characterized by malabsorption of fluid , electrolytes , and other nutrients . Although the remaining bowel undergoes morphological and functional adaptation , often these changes are inadequate to support the individual by enteral feedings , and parenteral nutrition is required to prevent dehydration , electrolyte disturbances , and malnutrition . Substances such as growth hormone , glutamine , and fiber exert bowel-specific trophic effects and either directly or indirectly influence nutrient absorption . This study was undertaken to determine whether the co-administration of exogenous growth hormone , supplemental glutamine , and a modified fiber-containing diet could enhance nutrient absorption in patients who had undergone massive intestinal resection . METHODS Ten patients ( 5 men , 5 women , aged 43 + /- 4 years ) with short bowel syndrome were studied 6 + /- 1 years after surgical resection . All patients were admitted to the Clinical Research Center for a 28-day period ; the first week served as a control period when nutritional ( enteral and parenteral ) and medical management simulated usual home therapy . Thereafter , eight patients received exogenous growth hormone , supplemental glutamine , and a modified high-carbohydrate , high-fiber diet . Two patients were treated with the modified diet alone . The efficiency of net nutrient absorption ( percent absorbed ) for total calories , protein , fat , carbohydrate , water , and sodium was calculated from the measured nutrient intake and stool losses . RESULTS Three weeks of treatment with growth hormone , glutamine , and a modified diet increased total caloric absorption from 60.1 + /- 6.0 % to 74.3 + /- 5.0 % ( p < or = .003 ) , protein absorption from 48.8 + /- 4.8 % to 63.0 + /- 5.4 % ( p < or = .006 ) , and carbohydrate absorption from 60.0 + /- 9.8 % to 81.5 + /- 5.3 % ( p < or = .02 ) . Fat absorption did not change ( 61.0 + /- 5.3 % to 60.3 + /- 7.9 % , p = NS ) . Water and sodium absorption increased from 45.7 + /- 6.7 % to 65.0 + /- 7.3 % ( p < or = .002 ) and from 49.0 + /- 9.8 % to 69.6 + /- 6.5 % ( p < or = .04 ) , respectively . These absorptive changes result ed in a decrease in stool output ( 1,783 + /- 414 g/d control period vs 1,308 + /- 404 g/d third week of treatment , p < or = .05 ) . Treatment with diet alone did not influence nutrient absorption or stool output . CONCLUSIONS The combined administration of growth hormone , glutamine , and a modified diet enhanced nutrient absorption from the remnant bowel after massive intestinal resection . These changes occurred in a group of patients that had previously failed to adapt to the provision of enteral nutrients . This therapy may offer an alternative to long-term dependence on total parenteral nutrition for patients with severe short bowel syndrome BACKGROUND AND AIMS Animal studies have reported positive effects of glutamine on intestinal absorption and morphology ; human studies have been less convincing . The aim of this study was to evaluate the effects of glutamine and diet on intestinal morphology , motility , and absorption . METHODS A r and omized , double blind , placebo-controlled crossover study in 8 patients with short-bowel on a high carbohydrate , low fat ( HCLF ) diet , was performed . Active treatment was oral glutamine ( 0.45 g kg(-1)day(-1 ) ) for eight weeks . Intestinal morphology was evaluated by light microscopy . Gastrointestinal transit was measured by dual gamma camera scintigraphy . D-xylose and fecal fat collection was used to evaluate intestinal absorption . Results of active treatment versus placebo were compared by the signed-rank test . RESULTS Morphology analysis , reported as median active treatment versus placebo , was villus height : 0.48 mm versus 0.50 mm , P=1.0 , and crypt depth : 0.11 mm versus 0.10 mm , P=0.469 . Percent D-xylose absorption , reported as median active treatment versus placebo , was 7 % versus 10.5 % , P=0.109 . There was not a significant difference in wet weight or fat absorption compared to placebo , P>0.05 . Likewise , gastrointestinal transit was not different compared to placebo . CONCLUSIONS The results of this controlled study would support that 8 weeks of treatment with oral glutamine and a HCLF diet does not significantly improve intestinal morphology , gastrointestinal transit , D-xylose absorption and stool losses in short bowel patients OBJECTIVE The authors investigate the effects of low dose recombinant human growth hormone ( rhGH ) on body composition and absorptive capacity in patients with short bowel syndrome from Crohn 's disease . SUMMARY BACKGROUND DATA Patients with short bowel syndrome usually are malnourished because of malabsorption . The anabolic effects of high doses of rhGH have been tested in different clinical catabolic conditions , recently including patients with short bowel syndrome . The authors have investigated the effects of low-dose rhGH in short bowel syndrome in a placebo-controlled crossover clinical trial . METHODS Ten patients were treated with daily subcutaneous doses of rhGH/placebo ( 0.5 international units/kg-1 per week-1 = 0.024 mg/kg-1 per day-1 ) for 8 weeks in a r and omized , double-blind , placebo-controlled crossover clinical trial with a minimum of 12 weeks wash-out . Absorptive capacity and biochemical parameters were investigated in a metabolic ward before treatment and during first and last week of treatment . Body composition was determined by DEXA-Scan ( Lunar DPX , Scanexport Medical , Helsingborg , Sweden ) , impedance analysis , and whole body potassium counting . RESULTS Low-dose rhGH doubled serum levels of insulin-like growth factor-1 ( IGF-1 ) and increased body weight , lean body mass , and total body potassium by 5 % ( p < 0.05 ) . Fat-free mass and total body water increased by 6 % ( p = 0.008 ) . Increases in IGF-1 levels correlated with increases in fat-free mass ( r = 0.77 , p < 0.02 ) . No significant changes in absorptive capacity of water , energy , or protein were detected . CONCLUSION Eight weeks of low-dose rhGH treatment leads to increases in body weight , lean body mass , and fat-free mass in patients with short bowel syndrome , correlated to increases in IGF-1 levels Objective The purpose of this study was to initially determine if growth hormone or nutrients , given alone or together , could enhance absorption from the remnant small bowel after massive intestinal resection . If clinical improvement were observed , this therapy would then be used to treat patients with the short-bowel syndrome over the long term . Summary Background Data Patients who undergo extensive resection of the gastrointestinal tract frequently develop malabsorption and require long-term parenteral nutrition . The authors hypothesized that the administration of growth factors and /or nutrients could enhance further compensation of the remnant intestine and thereby improve absorption . Specifically , animal studies have shown that there is enhanced cellularity with the administration of growth hormone ( GH ) or glutamine ( GLN ) , or a fiber-containing diet . Methods Initially , 17 studies were performed in 15 total parenteral nutrition (TPN)-dependent short-bowel patients over 3 to 4 weeks in the clinical research center ; the first week served as a control period , and during the next 1 to 3 weeks , the specific treatment was administered and evaluated . Throughout the study , food of known composition was provided and all stool was collected and analyzed to determine absorption across the remaining bowel . The effect of a high-carbohydrate , low-fat diet ( DIET ) , the amino acid glutamine ( GLN ) and growth hormone ( GH ) administered alone or in combination with the other therapies ( GH + GLN + DIET ) was evaluated . The treatment was exp and ed to 47 adults ( 25 men , 22 women ) with the short-bowel syndrome , dependent on TPN for 6 ± 1 years . The average age was 46 ± 2 years , and the average jejunal-ileal length was 50 ± 7 cm ( median 35 cm ) in those with all or a portion of colon and 102 ± 24 cm ( median 102 cm ) in those with no colon . After 28 days of therapy , the patients were discharged on only GLN + DIET . Results The initial balance studies indicated improvement in absorption of protein by 39 % accompanied by a 33 % decrease in stool output with the GH + GLN + DIET . In the long-term study , 40 % of the group remain off TPN and an additional 40 % have reduced their TPN requirements , with follow-up averaging a year and the longest being over 5 years BACKGROUND & AIMS Controversy surrounds a 3-week treatment with a high-dose ( 0.14 mg . kg(-1 ) . day(-1 ) ) growth hormone ( GH ) , glutamine , and high carbohydrate diet in home parenteral nutrition (HPN)-dependent patients with short-bowel syndrome ( SBS ) . This study assessed treatment with low-dose GH in these patients . METHODS Twelve adult HPN-dependent ( duration , 7 + /- 1 years ; mean + /- SEM ) patients with SBS ( small-bowel remnant length , 48 + /- 11 cm ) who were on an unrestricted hyperphagic diet were r and omized in a double-blind , placebo-controlled , crossover study . Patients received daily low-dose GH ( 0.05 mg . kg(-1 ) . day(-1 ) ) and placebo for two 3-week periods separated by a 1-week washout period . Net intestinal absorption of macronutrients was assessed using a duplicate diet ; nutritional assessment and blood tests were performed . Data from each group were compared using Wilcoxon rank sum test . RESULTS Treatment with GH increased intestinal absorption of energy ( 15 % + /- 5 % , P < 0.002 ) , nitrogen ( 14 % + /- 6 % , P < 0.04 ) , carbohydrates ( 10 % + /- 4 % , P < 0.04 ) , and fat ( 12 % + /- 8 % , NS ) . The increased food absorption represented 37 % + /- 16 % of total parenteral energy delivery . Body weight ( P < 0.003 ) , lean body mass ( P < 0.006 ) , D-xylose absorption ( P < 0.02 ) , insulin-like growth factor 1 ( P < 0.002 ) , and insulin-like growth factor binding protein 3 ( P < 0.002 ) increased , whereas uptake of GH binding protein decreased ( P < 0.01 ) , without any major adverse effect . CONCLUSIONS Three weeks of low-dose GH significantly improved intestinal absorption in HPN-dependent SBS patients who were on a hyperphagic western diet Objective : To determine if growth hormone ( GH ) and glutamine ( Gln ) might allow for a reduction in parenteral nutrition ( PN ) in individuals with short bowel syndrome . Background Data : Following massive intestinal resection , patients frequently sustain severe nutrient malabsorption and are dependent on PN for life . GH treatment with or without Gln might allow for a reduction in PN . Methods : A prospect i ve , double-blind , r and omized , placebo-controlled clinical trial performed in 41 adults dependent on PN . Following screening , patients were admitted to an in-house facility for 6 weeks . After 2 weeks of stabilization and dietary optimization , patients were r and omized to one of 3 treatment arms ( 1:2:2 ratio ) : oral Gln ( 30 g/day ) + GH placebo ( control group , n = 9 ) , Gln placebo + GH ( 0.1 mg/kg per day , n = 16 ) , or Gln + GH ( n = 16 ) . St and ard criteria based on clinical and laboratory measurements were followed to determine PN volume and content . After 4 weeks of treatment , patients were discharged and monitored ; GH and GH placebo were discontinued , but the diet with Gln or Gln placebo was continued for 3 months . Results : Patients receiving GH + Gln placebo + diet showed greater reductions in PN volume ( 5.9 ± 3.8 L/wk , mean ± SD ) , PN calories ( 4338 ± 1858 calories/wk ) , and PN infusions ( 3 ± 2 infusions/wk ) than corresponding reductions in the Gln + diet group ( 3.8 ± 2.4 L/wk ; 2633 ± 1341 calories/wk ; 2 ± 1 infusions/wk , P < 0.05 ) . Patients who received GH + Gln + diet showed the greatest reductions ( 7.7 ± 3.2 L/wk ; 5751 ± 2082 calories/wk ; 4 ± 1 infusions/wk , P < 0.001 versus Gln + diet ) . At the 3-month follow-up , only patients who had received GH + Gln + diet maintained significant reductions in PN ( P < 0.005 ) compared with the Gln + diet . Conclusions : Treatment with GH + diet or GH + Gln + diet initially permitted significantly more weaning from PN than Gln + diet . Only subjects receiving GH + Gln + diet maintained this effect for at least 3 months BACKGROUND High dose growth hormone , glutamine , and a high carbohydrate diet may improve intestinal function in short bowel patients . AIMS To investigate if growth hormone with glutamine and no change in diet improved intestinal function . PATIENTS AND METHODS Eight short bowel patients were r and omised in a double blind crossover study between placebo and growth hormone ( mean 0.12 mg/kg/day ) with oral ( mean 28 g/day ) and parenteral glutamine ( mean 5.2 g/day ) for 28 days . Balance studies were performed at baseline and five days after placebo and treatment were terminated . Dietary energy , carbohydrate , and fat were maintained as usual . RESULTS Growth hormone with glutamine did not improve intestinal absorption of energy ( baseline , placebo , treatment , mean : 46 % , 48 % , 46 % of oral intake , respectively ) , carbohydrate ( 71 % , 70 % , 71 % ) , fat ( 20 % , 15 % , 18 % ) , nitrogen ( 27 % , 18 % , 19 % ) , wet weight ( 37 % , 39 % , 31 % ) , sodium ( −16 % , −16 % , −36 % ) , potassium ( 43 % , 47 % , 33 % ) , calcium ( −16 % , −16 % , −15 % ) or magnesium ( −3 % , 4 % , 2 % ) compared with placebo or baseline ( p>0.05 ) five days after treatment was terminated . All patients experienced adverse effects . CONCLUSIONS Combined high dose growth hormone and glutamine administered for four weeks did not improve intestinal absorption five days after treatment was terminated in short bowel patients on their usual diet |
1,379 | 26,899,263 | Evidently , there are still profound gaps regarding very early and early discharge in children with cancer and febrile neutropenia . | BACKGROUND Chemotherapy-induced neutropenia is a common adverse effect in children with cancer .
Due to the high relative risk of infections and infectious complications , st and ard care for children with cancer and febrile neutropenia consists of routine hospitalization and parenteral administration of broad-spectrum antibiotics .
However , there are less serious causes of febrile neutropenia ; in a subgroup of these children , lengthy in-hospital treatment might be unnecessary .
Various research groups have studied the adjustment of st and ard care to shorten in-hospital treatment for children with cancer and febrile neutropenia at low risk for bacterial infections .
However , most of these studies were not done in a r and omized matter .
OBJECTIVES To evaluate whether early discharge ( mean/median of less than five days ) from in-hospital treatment was not inferior to non-early discharge ( mean/median of five days or more ) and whether very early discharge ( mean/median of less than 24 hours ) was not inferior to early discharge , non-early discharge , or a combination of these , in children with cancer and febrile neutropenia . | Background / Aims : There exists few pediatric data on the safety and efficacy of prophylactic antibiotics during chemotherapy-induced agranulocytosis . Methods : We prospect ively studied the incidence of infection-related fever in 38 children , aged 2 - 16 years , with acute myeloid leukemia ( AML ) over 121 chemotherapy treatment cycles . A prophylactic group ( n = 18 ) was given either vancomycin/cefepime ( 400 mg/m2 , q12 h/50 mg/kg , q12 h ) or piperacillin/tazobactam ( 110 mg/kg , q12 h ) . Control patients ( n = 20 ) received no preventive antibiotics . Results : The prophylactic group ( 59 treatment cycles ) experienced fever less frequently than the control group ( 0.4 vs. 0.9 events ; p < 0.001 ) , had a longer interval between agranulocytosis and fever ( 6.4 vs. 3.8 days ; p = 0.007 ) , had a shorter duration of hospitalization ( 21.5 vs. 28.5 days ; p < 0.001 ) , and had a lower rate of lung infection ( 38.8 vs. 80.0 % ; p < 0.001 ) . One patient taking vancomycin experienced a skin rash and 3 patients taking piperacillin/tazobactam had diarrhea ; these side effects subsided after antibiotics were discontinued . Conclusions : In children with AML , prophylactic antibiotics during the period of chemotherapy-induced agranulocytosis can effectively reduce the incidence of infectious fever and can shorten the average length of hospital stay , improving treatment success and quality of life PURPOSE To develop a score predicting the risk of adverse events ( AEs ) in pediatric patients with cancer who experience fever and neutropenia ( FN ) and to evaluate its performance . PATIENTS AND METHODS Pediatric patients with cancer presenting with FN induced by nonmyeloablative chemotherapy were observed in a prospect i ve multicenter study . A score predicting the risk of future AEs ( ie , serious medical complication , microbiologically defined infection , radiologically confirmed pneumonia ) was developed from a multivariate mixed logistic regression model . Its cross-vali date d predictive performance was compared with that of published risk prediction rules . Results An AE was reported in 122 ( 29 % ) of 423 FN episodes . In 57 episodes ( 13 % ) , the first AE was known only after re assessment after 8 to 24 hours of inpatient management . Predicting AE at re assessment was better than prediction at presentation with FN . A differential leukocyte count did not increase the predictive performance . The score predicting future AE in 358 episodes without known AE at re assessment used the following four variables : preceding chemotherapy more intensive than acute lymphoblastic leukemia maintenance ( weight = 4 ) , hemoglobin > or = 90 g/L ( weight = 5 ) , leukocyte count less than 0.3 G/L ( weight = 3 ) , and platelet count less than 50 G/L ( weight = 3 ) . A score ( sum of weights ) > or = 9 predicted future AEs . The cross-vali date d performance of this score exceeded the performance of published risk prediction rules . At an overall sensitivity of 92 % , 35 % of the episodes were classified as low risk , with a specificity of 45 % and a negative predictive value of 93 % . CONCLUSION This score , based on four routinely accessible characteristics , accurately identifies pediatric patients with cancer with FN at risk for AEs after re assessment PURPOSE To compare outcome and cost of ambulatory versus hospitalized management among febrile neutropenic children at low risk for invasive bacterial infection ( IBI ) . PATIENTS AND METHODS Children presenting with febrile neutropenia at six hospitals in Santiago , Chile , were categorized as high or low risk for IBI . Low-risk children were r and omly assigned after 24 to 36 hours of hospitalization to receive ambulatory or hospitalized treatment and monitored until episode resolution . Outcome and cost were determined for each episode and compared between both groups using predefined definitions and question naires . RESULTS A total of 161 ( 41 % ) of 390 febrile neutropenic episodes evaluated from June 2000 to February 2003 were classified as low risk , of which 149 were r and omly assigned to ambulatory ( n = 78 ) or hospital-based ( n = 71 ) treatment . In both groups , mean age ( ambulatory management , 55 months ; hospital-based management , 66 months ) , sex , and type of cancer were similar . Outcome was favorable in 74 ( 95 % ) of 78 ambulatory-treated children and 67 ( 94 % ) of 71 hospital-treated children ( P = NS ) . Mean cost of an episode was US 638 dollars ( 95 % CI , 572 dollars to 703 dollars ) and US 903 dollars ( 95 % CI , 781 dollars to 1,025 dollars ) for the ambulatory and hospital-based groups , respectively ( P = .003 ) . CONCLUSION For children with febrile neutropenia at low risk for IBI , ambulatory management is safe and significantly cost saving compared with st and ard hospitalized therapy A risk prediction model for invasive bacterial infection ( IBI ) was prospect ively evaluated among children presenting with cancer , fever , and neutropenia . The model incorporated assessment of 5 previously identified risk factors : serum level of C-reactive protein ( CRP ) > /=90 mg/L , hypotension , identification of relapse of leukemia as the cancer type , platelet count of < /=50,000 platelets/mm(3 ) , and recent receipt of chemotherapy [ 16 ] . Children were uniformly evaluated at enrollment and were classified as having high or low risk for IBI according to a model that considers the number and type of variables present . Of the 263 febrile episodes evaluated during a 17-month period , 140 ( 53 % ) were in IBI-positive children . The sensitivity , specificity , and positive and negative predictive values of the model were 92 % , 76 % , 82 % , and 90 % , respectively . Identification of these 5 risk factors during the first 24 h of hospitalization was helpful in discriminating between children with a high or low risk for IBI BACKGROUND Febrile neutropenia ( FN ) is a frequent , serious complication of intensive pediatric chemotherapy regimens . The aim of this trial was to compare quality of life ( QOL ) between inpatient and outpatient intravenous antibiotic management of children and adolescents with low risk febrile neutropenia ( LRFN ) . PROCEDURE In this r and omised non-blinded trial , patients between 1 and 21 years old , receiving low/moderate intensity chemotherapy were pre-consented and , on presentation to emergency ( ED ) with FN satisfying low risk criteria , r and omised to either outpatient or inpatient care with intravenous cefepime 50 mg/kg ( 12 hourly ) . All patients continued antibiotics for at least 48 hours , until afebrile for 24 hours and demonstrating a rising absolute neutrophil count ≥200/mm(3 ) . Several domains of QOL were examined by daily question naire . RESULTS Eighty-one patients presented to ED with 159 episodes of fever . Thirty-seven FN presentations involving 27 patients were r and omised to inpatient ( 18 ) and outpatient ( 19 ) management . Combined QOL mean scores for parents were higher for the outpatient group and scores for three specific parent variables ( keeping up with household tasks/time spent with partner/time spent with other children ) were higher among out patients . There was no difference in parent confidence/satisfaction in care between groups . Patients scored better in the outpatient group overall and for sleep and appetite . The mean length of fever was equivalent between groups and there were no serious adverse events attributable to cefepime or outpatient care . CONCLUSION Outpatient cefepime management of LRFN provided significant benefit to parents and patients across several QOL domains and appeared both feasible and safe During a 2-year period , all children with cancer , neutropenia , and fever who were admitted to Hospital de Niños Luis Calvo Mackenna ( Santiago , Chile ) were enrolled in a study of the safety of stopping antibiotic therapy on day 3 of treatment . Children who met predefined criteria for nonbacterial fever were r and omized on day 3 to stop ( group A ) or continue ( group B ) antibiotic therapy . A total of 220 children with cancer had 238 episodes of fever and neutropenia ; 68 children with 75 episodes met entry criteria for nonbacterial fever ( group A , 36 ; group B , 39 ) . Both groups were comparable in terms of age , gender , oncological disease , chemotherapy status , and initial neutrophil count . Resolution of symptoms occurred in 34 of 36 episodes in group A and 36 of 39 episodes in group B ( P > .05 ) . No deaths occurred , and bacterial superinfections were uncommon . For children with cancer as well as episodes of fever and neutropenia without an identifiable bacterial etiology at admission , stopping antibiotic therapy on day 3 was safe and not associated with a higher risk of bacterial superinfections Febrile neutropenia is a heterogeneous condition . Recently , several risk factors have been defined , permitting the definition of a lower risk group of patients who may benefit form less aggressive therapy . The use of an oral antibiotic approach was tested in the current trial AIM Empirical therapy for children with febrile neutropenia has traditionally consisted of combination antibiotics , usually a beta-lactam and an aminoglycoside . However , recent trends and international guidelines have now made monotherapy a feasible option in the management of this group of patients . We prospect ively evaluated the efficacy and safety of cefepime monotherapy in our population of paediatric cancer patients with febrile neutropenia . METHODS An audit was performed on children aged 16 years and younger presenting with fever and neutropenia who were managed with empirical single-agent cefepime . The patients were analysed for clinical outcome , documented infections and side-effects of the study drug . Success was defined as clinical improvement without treatment modification . Death or any change to the empirical antibiotic was considered as failure . RESULTS In this study 79 children ( median age 5.2 years ) with 133 episodes of febrile neutropenia were prospect ively studied between August 2004 and August 2005 . A microbiologically documented infection was seen in 26 episodes . The success rate of cefepime monotherapy was 60 % . The rate of survival through neutropenia ( with or without modification ) was 98 % . No significant adverse effects were seen . CONCLUSION Cefepime monotherapy is a safe and feasible option for treatment of childhood cancer patients with febrile neutropenia BACKGROUND The st and ard treatment of fever in chemotherapy-induced neutropenia ( FN ) includes emergency hospitalization and empirical intravenous antimicrobial therapy . This study determined if first-day step-down to oral outpatient treatment is not inferior to continued st and ard regarding safety and efficacy in children with low-risk FN . PROCEDURE In a r and omized controlled non-blinded multicenter study , pediatric patients with FN after non-myeloablative chemotherapy were reassessed after 8 - 22 hours of inpatient intravenous antimicrobial therapy . Low-risk patients were r and omized to first-day step-down to experimental ( outpatient , oral amoxicillin plus ciprofloxacin ) versus continued st and ard treatment . Exact non-inferiority tests were used for safety ( no serious medical complication ; non-inferiority margin of difference , 3.5 % ) and efficacy ( resolution of infection without recurrence , no modification of antimicrobial therapy , no adverse event ; 10 % ) . RESULTS In 93 ( 26 % ) of 355 potentially eligible FN episodes low-risk criteria were fulfilled , and 62 were r and omized , 28 to experimental ( 1 lost to follow-up ) and 34 to st and ard treatment . In intention-to-treat analyses , non-inferiority was not proven for safety [ 27 of 27 ( 100 % ) vs. 33 of 34 ( 97 % ; 1 death ) episodes ; 95 % upper confidence border , 6.7 % ; P = 0.11 ] , but non-inferiority was proven for efficacy [ 23 of 27 ( 85 % ) vs. 26 of 34 ( 76 % ) episodes ; 95 % upper confidence border , 9.4 % ; P = 0.045 ] . Per- protocol analyses confirmed these results . CONCLUSIONS In children with low-risk FN , the efficacy of first-day step-down to oral antimicrobial therapy with amoxicillin and ciprofloxacin in an outpatient setting was non-inferior to continued hospitalization and intravenous antimicrobial therapy . The safety of this procedure , however , was not assessable with sufficient power BACKGROUND Hospitalization with single or multi-agent antibiotic therapy has been the st and ard of care for treatment of febrile neutropenia in cancer patients . We hypothesized that an empiric antibiotic regimen that is effective and that can be administered once-daily will allow for improved hospital utilization by early transition to outpatient care . PROCEDURE Febrile pediatric cancer patients with anticipated prolonged neutropenia were r and omized between a regimen of once-daily ceftriaxone plus amikacin ( C + A ) and imipenem monotherapy ( control ) . Afebrile patients on C + A satisfying " Early Discharge Criteria " at 72 hr continued treatment as out patients . We compared the outcome , adverse events , duration of hospitalization , and cost between both groups . RESULTS A prospect i ve r and omized controlled clinical trial was conducted on 129 febrile episodes in pediatric cancer patients with prolonged neutropenia . No adverse events were seen in 32 children ( 84 % of study arm ) treated on an outpatient basis . We found a statistically significant difference between the duration of hospitalization of the C + A group [ median 5 days ] and control [ median 9 days](P < 0.001 ) , per episode antibiotic cost ( P < 0.001 ) and total episode cost ( P < 0.001 ) . There was no statistically significant difference in the response to treatment at 72 hr or after necessary antimicrobial modifications . CONCLUSIONS We conclude that pediatric febrile cancer patients initially considered at risk for sepsis due to prolonged neutropenia can be re-evaluated at 72 hr for outpatient therapy . The convenience , low incidence of adverse effects , and cost benefit of the once-daily regimen of C + A may be particularly useful to reduce the overall treatment costs and duration of hospitalization Background Outpatient oral therapy is infrequently used in pediatric low-risk febrile neutropenia ( LRFN ) as there is insufficient data regarding its equivalence as compared with parenteral therapy . Methods This is a single institutional , r and omized control trial in pediatric LRFN aged 2 to 15 years , in which 123 episodes in 88 patients were r and omized to outpatient oral ofloxacin 7.5 mg/kg 12 hourly and amoxycillin-clavulanate 12.5 mg/kg 8 hourly or outpatient intravenous ( IV ) ceftriaxone 75 mg/kg and amikacin 15 mg/kg once daily after blood cultures . Results Out of 119 evaluable episodes , one-third were leukemia patients in maintenance and rest were solid tumors . Success was achieved in 55/61 ( 90.16 % ) and 54/58 ( 93.1 % ) in oral and IV arms , respectively , ( P=0.56 ) . There were 3 hospitalizations but no mortality . Median days to resolution of fever , absolute neutrophil count > 500/mm3 and antibiotic use were 3 , 5 , and 6 days in both arms . There were 5 blood culture isolates ( 3 gram-positive and 2 gram-negative bacteria ) . Failure of outpatient therapy was associated with perianal infections , bacteremia , febrile neutropenia onset before day 9 of chemotherapy in solid tumors and Vincristine , actinomycin-D , and cyclophosphamide chemotherapy for rhabdomyosarcoma . All gram-positive isolates were successes , whereas both gram-negative isolates were failures . Diarrhea in IV arm and Vincristine , actinomycin-D , and cyclophosphamide chemotherapy in the oral arm predicted failure in subgroup analysis . Conclusions Outpatient therapy is efficacious and safe in pediatric LRFN . There was no difference in outcome in oral versus IV outpatient therapy . Amoxycillin-clavulanate and ofloxacin may be the oral regimen of choice Empiric oral antibiotic therapy for febrile neutropenic cancer patients has been suggested as a means to decrease hospitalization , but the safety of this approach has not been adequately studied in children . We compared continued iv antibiotic therapy with switching treatment to orally administered cefixime in a group of selected febrile neutropenic children for whom blood cultures were sterile after 48 h of incubation . Two hundred episodes of febrile neutropenia were studied ( 156 patients ) , and 100 episodes were r and omized to receive each treatment . Failure to respond to therapy was defined by documented or suspected bacterial infection , recurrent fever , or discontinuation of assigned therapy for any reason before neutropenia resolved . Rates of treatment failure were similar in the oral cefixime group ( 28 % ) and in the iv antibiotic group ( 27 % ; P=1.0 ) . Results support the safety of oral cefixime therapy for low-risk febrile neutropenic children , a therapeutic approach that would facilitate earlier outpatient management and decrease the costs of treatment Purpose : We report a prospect i ve study on brief IV antibiotic therapy in selected children with cancer experiencing fever and neutropenia ( FN ) after chemotherapy . Patients and methods : All children with FN ( T⩽≥38 ° C ; ANC<0.5<l09/L ) were hospitalized for treatment with broad spectrum IV antibiotics . They were divided into three groups : group A ( no infection ) , group B ( clinical ly documented infection ) , and group C ( bacteremia ) . Children in group A ( and some children in group B ) were discharged before recovery of neutropenia , if afebrile and in good condition . Results : Eighty-eight consecutive episodes of FN occurred in 30 children . Children in group A ( 44 episodes ; 50 % ) received IV antibiotics for a median of 3 days ; on 25 occasions ( 57 % ) , IV antibiotics were stopped before recovery of neutropenia . In children in group B ( 30 episodes ; 34 % ) , early discharge was allowed in eight cases of minor infections ( 27 % ) ; six received oral antibiotics . Two children ( group A ) were rehospitalized for recurrent FN but recovered without complications . Conclusion : In chemotherapy-induced neutropenia , children hospitalized for fever but without documented infections and some children with minor infections can cautiously be discharged before evidence of bone marrow recovery if afebrile and in good general condition |
1,380 | 23,922,064 | For SMBP monitoring plus additional support versus SMBP monitoring alone or with less intense additional support ( 13 comparisons ) , low-strength evidence fails to support a difference .
Across all comparisons , evidence for clinical outcomes is insufficient .
For other surrogate or intermediate outcomes , low-strength evidence fails to show differences .
Self-measured BP monitoring with or without additional support lowers BP compared with usual care , but the BP effect beyond 12 months and long-term benefits remain uncertain .
Additional support enhances the BP-lowering effect . | BACKGROUND Clinical guidelines recommend that adults with hypertension self-monitor their blood pressure ( BP ) .
PURPOSE To summarize evidence about the effectiveness of self-measured blood pressure ( SMBP ) monitoring in adults with hypertension . | The efficacy of self-recording of blood pressure in the management of hypertension was assessed in a r and omized clinical trial involving 140 persons who had been receiving antihypertensive therapy for a year or more , but whose diastolic blood pressure had remained at 95 mm Hg or higher . To control for the increased attention implicit in self-recording , which might affect blood pressure , the patients were assigned at r and om to one of the four groups : self-recording and monthly home visits , self-recording only , monthly home visits only , and neither self-recording nor monthly home visits . This design also permitted assessment of the effect of home visits . During the 6-month experiment no significant differences were apparent between the groups in either compliance or diastolic blood pressure . However , both self-recording and monthly home visits produced a reduction in blood pressure among patients who admitted to difficulty remembering to take their pills ; a reduction was not seen among patients who said they had no such difficulty . This confirmed an earlier observation suggesting that this easily identified group of patients may be the most responsive to intervention programs Background —Hypertension is a leading mortality risk factor yet inadequately controlled in most affected subjects . Effective programs to address this problem are lacking . We hypothesized that an information technology – supported management program could help improve blood pressure ( BP ) control . Methods and Results —This r and omized controlled trial included 223 primary care hypertensive subjects with mean 24-hour BP > 130/80 and daytime BP > 135/85 mm Hg measured with ambulatory monitoring ( ABPM ) . Intervention subjects received a BP monitor and access to an information technology – supported adherence and BP monitoring system providing nurses , pharmacists , and physicians with monthly reports . Control subjects received usual care . The mean ( ±SD ) follow-up was 348 ( ±78 ) and 349 ( ±84 ) days in the intervention and control group , respectively . The primary end point of the change in the mean 24-hour ambulatory BP was consistently greater in intervention subjects for both systolic ( −11.9 versus −7.1 mm Hg ; P<0.001 ) and diastolic BP ( −6.6 versus −4.5 mm Hg ; P=0.007 ) . The proportion of subjects that achieved Canadian Guideline target BP ( 46.0 % versus 28.6 % ) was also greater in the intervention group ( P=0.006 ) . We observed similar BP declines for ABPM and self-recorded home BP suggesting the latter could be an alternative for confirming BP control . The intervention was associated with more physician-driven antihypertensive dose adjustments or changes in agents ( P=0.03 ) , more antihypertensive classes at study end ( P=0.007 ) , and a trend toward improved adherence measured by prescription refills ( P=0.07 ) . Conclusions —This multidisciplinary information technology – supported program that provided feedback to patients and healthcare providers significantly improved blood pressure levels in a primary care setting OBJECTIVE : To evaluate the effectiveness of a community pharmacist-based home blood pressure ( BP ) monitoring program . DESIGN : Trial of a high-intensity ( HI ) versus low-intensity ( LI ) intervention r and omized in 12 community pharmacies . The HI intervention comprised 4 face-to-face visits with a trained pharmacist . Pharmacists provided patient-specific education about hypertension . Following the first and third visits , patients were provided with a home BP monitoring device and instructed to measure their BP at least once daily for the next month . Home BP readings were used by the pharmacists to develop treatment recommendations for the patient ’s physician . Recommendations were discussed with the physician and , if approved , implemented by the pharmacist . In the LI intervention , pharmacists measured patients BP in the pharmacy and referred them to their physician for evaluation . PARTICIPANTS : Patients with uncontrolled BP at baseline . MEASUREMENTS : The main outcomes were the differences in systolic and diastolic BP ( SBP and DBP ) from baseline to follow-up between the HI and LI patients . RESULTS : The study enrolled 125 patients , 64 in the HI and 61 in the LI group . From baseline , SBP declined 13.4 mmHg in the HI group and 9.0 mmHg in the LI group . At the final visit , the difference in SBP/DBP change between the HI and LI group was −4.5/−3.2 mmHg ( P=.12 for SBP and P=.03 for DBP ) . CONCLUSIONS : The HI intervention achieved a lower DBP and this model could be a strategy for patients with hypertension Home blood pressure monitoring ( HBPM ) overcomes many of the limitations of traditional office blood pressure ( BP ) measurement and is both cheaper and easier to perform than ambulatory BP monitoring . Monitors that use the oscillometric method are currently available that are accurate , reliable , easy to use , and relatively inexpensive . An increasing number of patients are using them regularly to check their BP at home , but although this has been endorsed by national and international guidelines , detailed recommendations for their use have been lacking . There is a rapidly growing literature showing that measurements taken by patients at home are often lower than readings taken in the office and closer to the average BP recorded by 24-hour ambulatory monitors , which is the BP that best predicts cardiovascular risk . Because of the larger numbers of readings that can be taken by HBPM than in the office and the elimination of the white-coat effect ( the increase of BP during an office visit ) , home readings are more reproducible than office readings and show better correlations with measures of target organ damage . In addition , prospect i ve studies that have used multiple home readings to express the true BP have found that home BP predicts risk better than office BP ( class IIa ; level of evidence A ) . This call-to-action article makes the following recommendations : 1 ) It is recommended that HBPM should become a routine component of BP measurement in the majority of patients with known or suspected hypertension ; 2 ) Patients should be advised to purchase oscillometric monitors that measure BP on the upper arm with an appropriate cuff size and that have been shown to be accurate according to st and ard international protocol s. They should be shown how to use them by their healthcare providers ; 3 ) Two to three readings should be taken while the subject is resting in the seated position , both in the morning and at night , over a period of 1 week . A total of > /=12 readings are recommended for making clinical decisions ; 4 ) HBPM is indicated in patients with newly diagnosed or suspected hypertension , in whom it may distinguish between white-coat and sustained hypertension . If the results are equivocal , ambulatory BP monitoring may help to establish the diagnosis ; 5 ) In patients with prehypertension , HBPM may be useful for detecting masked hypertension ; 6 ) HBPM is recommended for evaluating the response to any type of antihypertensive treatment and may improve adherence ; 7 ) The target HBPM goal for treatment is < 135/85 mm Hg or < 130/80 mm Hg in high-risk patients ; 8) HBPM is useful in the elderly , in whom both BP variability and the white-coat effect are increased ; 9 ) HBPM is of value in patients with diabetes , in whom tight BP control is of paramount importance ; 10 ) Other population s in whom HBPM may be beneficial include pregnant women , children , and patients with kidney disease ; and 11 ) HBPM has the potential to improve the quality of care while reducing costs and should be reimbursed It is still uncertain whether one can safely base treatment decisions on self-measurement of blood pressure . In the present study , we investigated whether antihypertensive treatment based on self-measurement of blood pressure leads to the use of less medication without the loss of blood pressure control . We r and omly assigned 430 hypertensive patients to receive treatment either on the basis of self-measured pressures ( n=216 ) or office pressures ( OPs ; n=214 ) . During 1-year follow-up , blood pressure was measured by office measurement ( 10 visits ) , ambulatory monitoring ( start and end ) , and self-measurement ( 8 times , self-pressure group only ) . In addition , drug use , associated costs , and degree of target organ damage ( echocardiography and microalbuminuria ) were assessed . The self-pressure group used less medication than the OP group ( 1.47 versus 2.48 drug steps ; P<0.001 ) with lower costs ( $ 3222 versus $ 4420 per 100 patients per month ; P<0.001 ) but without significant differences in systolic and diastolic OP values ( 1.6/1.0 mm Hg ; P=0.25/0.20 ) , in changes in left ventricular mass index ( -6.5 g/m(2 ) versus -5.6 g/m(2 ) ; P=0.72 ) , or in median urinary microalbumin concentration ( -1.7 versus -1.5 mg per 24 hours ; P=0.87 ) . Nevertheless , 24-hour ambulatory blood pressure values at the end of the trial were higher in the self-pressure than in the OP group : 125.9 versus 123.8 mm Hg ( P<0.05 ) for systolic and 77.2 versus 76.1 mm Hg ( P<0.05 ) for diastolic blood pressure . These data show that self-measurement leads to less medication use than office blood pressure measurement without leading to significant differences in OP values or target organ damage . Ambulatory values , however , remain slightly elevated for the self-pressure group BACKGROUND St and ard office-based approaches to controlling hypertension show limited success . Such suboptimal hypertension control reflects in part the absence of both an infrastructure for patient education and frequent , regular blood pressure ( BP ) monitoring . We tested the efficacy of a physician-directed , nurse-managed , home-based system for hypertension management with st and ardized algorithms to modulate drug therapy , based on patients ' reports of home BP . METHODS We r and omized out patients requiring drug therapy for hypertension according to the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) criteria to receive usual medical care only ( UC , n = 76 ) or usual care plus nurse care management intervention ( INT , n = 74 ) over a 6-month period . RESULTS Patients receiving INT achieved greater reductions in office BP values at 6 months than those receiving UC : 14.2 + /- 18.1 versus 5.7 + /- 18.7 mm Hg systolic ( P < .01 ) and 6.5 + /- 10.0 versus 3.4 + /- 7.9 mm Hg diastolic , respectively ( P < .05 ) . At 6 months , we observed one or more changes in drug therapy in 97 % of INT patients versus 43 % of UC patients , and 70 % of INT patients received two or more drugs versus 46 % of UC . Average daily adherence to medication , measured by electronic drug event monitors , was superior among INT subjects ( mean + /- SD , 80.5 % + /- 23.0 % ) than among UC subjects ( 69.2 + /- 31.1 % ; t(113 ) = 2.199 , P = .03 ) . There were no significant adverse drug reactions in either group . CONCLUSIONS Telephone-mediated nurse management can successfully address many of the systems-related and patient-related issues that limit pharmacotherapeutic effectiveness for hypertension BACKGROUND Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness . METHODS The authors conducted a r and omized , controlled trial comparing telemedicine case management to usual care , with blinding of those obtaining outcome data , in 1,665 Medicare recipients with diabetes , aged 55 years or greater , and living in federally design ated medically underserved areas of New York State . The primary endpoints were HgbA1c , blood pressure , and low-density lipoprotein ( LDL ) cholesterol levels . RESULTS In the intervention group ( n = 844 ) , mean HgbA1c improved over one year from 7.35 % to 6.97 % and from 8.35 % to 7.42 % in the subgroup with baseline HgbA1c > or = 7 % ( n = 353 ) . In the usual care group ( n = 821 ) mean HgbA1c improved over one year from 7.42 % to 7.17 % . Adjusted net reductions ( one-year minus baseline mean values in each group , compared between groups ) favoring the intervention were as follows : HgbA1c , 0.18 % ( p = 0.006 ) , systolic and diastolic blood pressure , 3.4 ( p = 0.001 ) and 1.9 mm Hg ( p < 0.001 ) , and LDL cholesterol , 9.5 mg/dL ( p < 0.001 ) . In the subgroup with baseline HgbA1c > or = 7 % , net adjusted reduction in HgbA1c favoring the intervention group was 0.32 % ( p = 0.002 ) . Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York . CONCLUSION Telemedicine case management improved glycemic control , blood pressure levels , and total and LDL cholesterol levels at one year of follow-up African Americans have a higher prevalence of hypertension and poorer cardiovascular and renal outcomes than white Americans . The objective of this study was to determine whether a telephonic nurse disease management ( DM ) program design ed for African Americans is more effective than a home monitoring program alone to increase blood pressure ( BP ) control among African Americans enrolled in a national health plan . A prospect i ve r and omized controlled study ( March 2006-December 2007 ) was conducted , with 12 months of follow-up on each subject . A total of 5932 health plan members were r and omly selected from the population of self-identified African Americans , age 23 and older , in health maintenance organization plans , with hypertension ; 954 accepted , 638 completed initial assessment , and 485 completed follow-up assessment . The intervention consisted of telephonic nurse DM ( intervention group ) including educational material s , lifestyle and diet counseling , and home BP monitor vs. home BP monitor alone ( control group ) . Measurements included proportion with BP < 120/80 , mean systolic BP , mean diastolic BP , and frequency of BP self-monitoring . Results revealed that systolic BP was lower in the intervention group ( adjusted means 123.6 vs. 126.7 mm Hg , P = 0.03 ) ; there was no difference for diastolic BP . The intervention group was 50 % more likely to have BP in control ( odds ratio [ OR ] = 1.50 , 95 % confidence interval [ CI ] 0.997 - 2.27 , P = 0.052 ) and 46 % more likely to monitor BP at least weekly ( OR 1.46 , 95 % CI 1.07 - 2.00 , P = 0.02 ) than the control group . A nurse DM program tailored for African Americans was effective at decreasing systolic BP and increasing the frequency of self-monitoring of BP to a greater extent than home monitoring alone . Recruitment and program completion rates could be improved for maximal impact A clinical trial of 204 untreated patients with mild hypertension was conducted to assess the effect of home blood pressure monitoring on blood pressure level , pharmacologic treatment , reduction of risk factors , and use of health services . After 1 year , no statistically significant differences were found between the treatment and control groups . The findings indicate that , while home blood pressure monitoring may be useful , it has no measurable short-term impact on these aspects of blood pressure management for patients with mild hypertension There continues to be a need for improved medical management of diabetes patients with hypertension in primary care . While several care models have shown effectiveness in achieving various outcomes among these patients , it remains unclear what care model is most effective in improving blood pressure control in primary care . In this prospect i ve study , 54 patients with type 2 diabetes mellitus and blood pressure of > 140/90 identified through the registry , were r and omized into three groups . Group A attended a nurse educator-conducted class on diabetes and hypertension , group B attended the same class and was asked to monitor their home blood pressure using provided device , and group C served as control ( usual care ) . Of the 24 subjects who completed the study , only 20 % achieved the target blood pressure of < 130/80 and there was no statistical difference in mean systolic and diastolic blood pressures among the three groups ( p > 0.05 ) . Efforts to intensify management of hypertension among type 2 diabetes patients did not result in better blood pressure control compared to usual care . Studies looking into factors which limit patients ’ participation in group classes and determining patients ’ preferences in disease management would be helpful in ensuring success of any chronic disease management program Aim . To compare the effectiveness of antihypertensive treatment based on telemonitoring of home blood pressure ( BP ) and conventional monitoring of office BP . Methods . Hypertensive patients ( n = 236 ) participated in a r and omized , controlled study . In the intervention group , antihypertensive treatment was based on home BP monitoring . BP readings were registered by a PDA and automatically transmitted to a server , by which the patient and doctor could communicate . In the control group , patients received usual care with office visits to adjust antihypertensive treatment as needed . Primary outcome was difference in systolic daytime ambulatory BP monitoring ( ABPM ) change between baseline and 6 months . Results . In both groups , systolic daytime ABPM decreased significantly from baseline to follow‐up . The decrease in systolic daytime ABPM was −11.9 mmHg in the intervention group and −9.6 mmHg in the control group ( mean difference −2.3 [ 95 % CI −6.1 to −1.5 ] , p = 0.225 ) . The likelihood of daytime ABPM normalization was similar in the two groups [ 32/113 ( 28 % ) vs 46/123 ( 37 % ) , p = 0.139 ] . Conclusion . Antihypertensive treatment based on telemonitoring of home BP was as effective as usual monitoring of office BP with regards to reduction of BP . Trial registration : Clinical Trials.gov identifier : NCT00282334 This research reports level of blood pressure control and ability to maintain newly discovered hypertensives in a municipal hospital setting by use of family- and self-monitored home blood pressure units . Three hundred ninety-six patients were r and omized into family- and self-monitored blood pressure groups and a control group . Findings indicate that the use of either self- or family-read cuffs is effective in the first six months of treatment in lowering blood pressures . The data are suggestive of a beneficial effect of the use of cuffs for up to 18 months ; however , with additional time in the study , no differences in the level of blood pressure control could be demonstrated between groups . The use of family-monitored blood pressure cuffs produces a lower drop-out rate than does the use of no cuff . The effect on drop outs is substantial for the first year of treatment , but beyond 12 months , the family-read cuff is also more effective than no cuff in reducing drop outs The evaluation in real-life setting s of services for the follow-up and control of hypertensive patients is a complex intervention , which still needs analysis of the roles , tasks , and re sources involved in the basic items : patient , healthcare professional , and the interaction between the two . To evaluate the impact of patient-general practitioner ( GP ) short-messages-based interaction , isolated from other items , on the degree of hypertension control in the follow-up of medium-to-low-risk patients in primary care , a r and omized controlled trial has been performed : 38 GPs enrolled 285 hypertensive patients who recorded the results of self-blood-pressure ( BP ) monitoring , heart rate , and body weight , and completed an optional question naire in an identical manner over a six-month period . The telemedicine group ( TmG ) sent the data to a telemedicine-based system that enabled patient-GP interaction ; the control group ( CG ) recorded the data on paper and could only deliver it to their GP personally in the routine visits . In the TmG , the results were better , but not significantly so , for : 1 ) degree of hypertension control , in terms of the percentage of uncontrolled hypertensives at the final visit ( TmG versus CG : 31.7 % versus 35.6 % ; p = 0.47 ) ; 2 ) reduction in hypertension during follow-up , comparing measurements ( performed by a professional ) at the initial and final visits of systolic BP ( 15.5 versus 11.9 ; p = 0.13 ) and diastolic BP ( 9.6 versus 4.4 ; p = 0.40 ) ; and 3 ) adherence to the protocol within compliance levels of interest in a real-life follow-up service : Gt50 % ( 84.8 % versus 73.3 % ) and Gt25 % ( 92.4.8 % versus 75.4 % ) ( p = 0.053 ) . Other factors such as average values of self-measured systolic BP , diastolic BP and heart rate , acceptability of the protocol , and median number of consultations and hospital admissions were similar in both groups . Outcomes show that , taken alone , the patient-GP short-messages-based interaction has very little impact on the degree of hypertension control in patients with this profile . In complex interventions , to discriminate the impact of each of its components in isolation will enable us to design an efficient follow-up service , little dem and ing in terms of healthcare professional dedication , and optimized in other basic aspects CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care . OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older , ethnically diverse , medically underserved patients with diabetes . DESIGN , Setting , and Patients A r and omized controlled trial was conducted , comparing telemedicine case management to usual care , with blinded outcome evaluation , in 1,665 Medicare recipients with diabetes , aged > /= 55 years , residing in federally design ated medically underserved areas of New York State . Interventions Home telemedicine unit with nurse case management versus usual care . Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c ( HgbA1c ) , low density lipoprotein ( LDL ) cholesterol , and blood pressure levels . RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints ( HgbA1c , p = 0.001 ; LDL , p < 0.001 ; systolic and diastolic blood pressure , p = 0.024 ; p < 0.001 ) . Estimated differences ( 95 % CI ) in year 5 were 0.29 ( 0.12 , 0.46)% for HgbA1c , 3.84 ( -0.08 , 7.77 ) mg/dL for LDL cholesterol , and 4.32 ( 1.93 , 6.72 ) mm Hg for systolic and 2.64 ( 1.53 , 3.74 ) mm Hg for diastolic blood pressure . There were 176 deaths in the intervention group and 169 in the usual care group ( hazard ratio 1.01 [ 0.82 , 1.24 ] ) . CONCLUSIONS Telemedicine case management result ed in net improvements in HgbA1c , LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries . Mortality was not different between the groups , although power was limited . Trial Registration http:// clinical trials.gov Identifier : NCT00271739 BACKGROUND Control of blood pressure is a key component of cardiovascular disease prevention , but is difficult to achieve and until recently has been the sole preserve of health professionals . This study assessed whether self-management by people with poorly controlled hypertension result ed in better blood pressure control compared with usual care . METHODS This r and omised controlled trial was undertaken in 24 general practice s in the UK . Patients aged 35 - 85 years were eligible for enrolment if they had blood pressure more than 140/90 mm Hg despite antihypertensive treatment and were willing to self-manage their hypertension . Participants were r and omly assigned in a 1:1 ratio to self-management , consisting of self-monitoring of blood pressure and self-titration of antihypertensive drugs , combined with telemonitoring of home blood pressure measurements or to usual care . R and omisation was done by use of a central web-based system and was stratified by general practice with minimisation for sex , baseline systolic blood pressure , and presence or absence of diabetes or chronic kidney disease . Neither participants nor investigators were masked to group assignment . The primary endpoint was change in mean systolic blood pressure between baseline and each follow-up point ( 6 months and 12 months ) . All r and omised patients who attended follow-up visits at 6 months and 12 months and had complete data for the primary outcome were included in the analysis , without imputation for missing data . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N17585681 . FINDINGS 527 participants were r and omly assigned to self-management ( n=263 ) or control ( n=264 ) , of whom 480 ( 91 % ; self-management , n=234 ; control , n=246 ) were included in the primary analysis . Mean systolic blood pressure decreased by 12.9 mm Hg ( 95 % CI 10.4 - 15.5 ) from baseline to 6 months in the self-management group and by 9.2 mm Hg ( 6.7 - 11.8 ) in the control group ( difference between groups 3.7 mm Hg , 0.8 - 6.6 ; p=0.013 ) . From baseline to 12 months , systolic blood pressure decreased by 17.6 mm Hg ( 14.9 - 20.3 ) in the self-management group and by 12.2 mm Hg ( 9.5 - 14.9 ) in the control group ( difference between groups 5.4 mm Hg , 2.4 - 8.5 ; p=0.0004 ) . Frequency of most side-effects did not differ between groups , apart from leg swelling ( self-management , 74 patients [ 32 % ] ; control , 55 patients [ 22 % ] ; p=0.022 ) . INTERPRETATION Self-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care . FUNDING Department of Health Policy Research Programme , National Coordinating Centre for Research Capacity Development , and Midl and s Research Practice s Consortium PURPOSE The present study evaluated whether an intervention using a short message service ( SMS ) by cellular phone and Internet would improve blood pressure , weight control , and serum lipids of obese patients with hypertension during 8 weeks . METHODS This is a quasi-experimental design with pre- and follow-up tests . Participants were recruited from the family medicine outpatient department of tertiary care hospital located in an urban city of South Korea . Twenty-eight patients were assigned to an intervention group and 21 to a control group . The goal of intervention was to bring blood pressure , body weight , and serum lipids levels close to normal ranges . Patients in the intervention group were requested to record their blood pressure and body weight in a weekly web based diary through the Internet or by cellular phones . The research ers sent optimal recommendations as an intervention to each patient , by both cellular phone and Internet weekly . The intervention was applied for 8 weeks . RESULTS Systolic ( SBP ) and diastolic blood pressures ( DBP ) significantly decreased by 9.1 and 7.2 mmHg respectively at 8 weeks from the baseline in the intervention group ( p<0.05 ) . However , after 8 weeks from the baseline both SBP and DBP in the control group had not changed significantly . Yet , There were significant mean decreases in body weight and waist circumference by 1.6 kg ( p<0.05 ) and 2.8 cm ( p<0.05 ) in the intervention group , respectively . In the control group increases in body weight and waist circumference ( p<0.05 ) mean changes were also significant . High density lipoprotein cholesterol ( HDL-C ) significantly increased , with a mean change of 3.7 mg/dl at 8 weeks from baseline in the intervention group ( p<0.05 ) . The mean change of HDL-C in the control group was , however , not significant . CONCLUSION During 8 weeks using this web-based intervention by way of cellular phone and Internet SMS improved blood pressure , body weight , waist circumference , and HDL-C in patients with obese hypertension BACKGROUND The measurement of blood pressure ( BP ) at home by patients with hypertension is increasingly used to assess and monitor BP . Evidence for its effectiveness in improving BP control is mixed . METHODS To determine if home BP monitoring improves BP a pragmatic cluster r and omized contolled trial was carried out in family practice s in southeastern Ontario , Canada . Family practice patients with uncontrolled hypertension were recruited to the trail . Patients were divided into two groups : one with at least weekly measurements of BP at home , recording those measurements and showing those to the family physician during office visits for hypertension and the control group were given usual care . The primary outcome was mean awake BP on ambulatory monitoring at 6- and 12-month follow-up and the secondary outcomes were mean BP on full 24-hour ambulatory blood pressure monitoring ( ABPM ) , mean sleep BP on ABPM and BP on the BpTRU device , all at 6- and 12-month follow-up . RESULTS Home BP monitoring did not improve BP compared to usual care at 12-month follow-up : mean awake systolic BP on ABPM [ 141.1 versus 142.8 mmHg , mean difference 1.7 mmHg ; 95 % confidence interval ( CI ) -0.6 to 4.0 , P = 0.314 ] and mean awake diastolic BP on ABPM ( 78.7 versus 79.4 mmHg , mean difference 0.7 mmHg ; 95 % CI -7.7 to 9.1 , P = 0.398 ) . Similar negative results were obtained for men and women separately . However , outcomes using the full 24-hour ABPM and the BpTRU device showed a significantly lower diastolic BP at 12 months . When analysis was done by sex , this effect was shown to be only in men . CONCLUSION Home BP monitoring may improve BP control in men with hypertension PURPOSE Poor blood pressure control is common in the United States . We conducted a study to determine whether health coaching with home titration of antihypertensive medications can improve blood pressure control compared with health coaching alone in a low-income , predominantly minority population . METHODS We r and omized 237 patients with poorly controlled hypertension at a primary care clinic to receive either home blood pressure monitoring , weekly health coaching , and home titration of blood pressure medications if blood pressures were elevated ( n = 129 ) vs home blood pressure monitoring and health coaching but no home titration ( n = 108 ) . The primary outcome was change in systolic blood pressure from baseline to 6 months . RESULTS Both the home-titration arm and the no – home-titration arm had a reduction in systolic blood pressure , with no significant difference between them . When both arms were combined and analyzed as a before-after study , there was a mean decrease in systolic blood pressure of 21.8 mm Hg ( P < .001 ) as well as a decrease in the number of primary care visits from 3.5 in the 6 months before the study to 2.6 during the 6-month study period ( P < .001 ) and 2.4 in the 6 months after the study ( P < .001 ) . The more coaching encounters patients had , the greater their reduction in blood pressure . CONCLUSIONS Blood pressure control in a low-income , minority population can be improved by teaching patients to monitor their blood pressure at home and having nonprofessional health coaches assist patients , in particular , by counseling them on medication adherence . The improved blood pressure control can be achieved while reducing the time spent by physicians This prospect i ve , r and omized , controlled study evaluated the impact of pharmacist-initiated home blood pressure monitoring and intervention on blood pressure control , therapy compliance , and quality of life ( QOL ) . Subjects were 36 patients with uncontrolled stage 1 or 2 hypertension . Eighteen subjects received home blood pressure monitors , a diary , and instructions to measure blood pressure twice every morning . Home measurements were evaluated by a clinical pharmacist by telephone , and the patient 's family physician was contacted with recommendations if mean monthly values were 140/90 mm Hg or higher . Eighteen control patients did not receive home monitors or pharmacist intervention . Office blood pressure measurements and QOL surveys ( SF-36 ) were obtained at baseline and after 6 months . Mean absolute reductions in systolic and diastolic pressures were significantly reduced from baseline in intervention subjects ( 17.0 and 10.5 mm Hg , both p < 0.0001 ) but not in controls ( 7.0 and 3.8 mm Hg , p = 0.12 and p = 0.09 ) . More intervention subjects ( 8) had blood pressure values below 140/90 at 6 months compared with controls ( 4 ) . During the study 83.3 % ( 15 ) of intervention subjects had drug therapy changes versus 33 % ( 6 ) of controls ( p < 0.01 ) . Compliance and QOL were not significantly affected . Our data suggest that the combination of pharmacist intervention with home monitoring can improve blood pressure control in patients with uncontrolled hypertension . This may be related to increased modifications of drug regimens 38 hypertensive Canadian steelworkers who were neither compliant with medications nor at goal diastolic blood-pressure six months after starting treatment were allocated either to a control group or to an experimental group who were taught how to measure their own blood-pressures , asked to chart their home blood-pressures and pill taking , and taught how to tailor pill taking to their daily habits and rituals ; these men were also seen fortnightly by a highschool graduate with no formal health professional training who reinforced the experimental manoeuvres and rewarded improvements in compliance and blood-pressure . Six months later , average compliance had fallen by 1.5 % in the control group but rose 21.3 % in the experimental group . Blood-pressures fell in 17 of 20 experimental patients ( to goal in 6 ) and in 10 of 18 control patients ( to goal in 2 ) Screening of 6,144 patients in a general practice clinic to assist physician case-finding uncovered 983 ( 16 % ) who were uncontrolled hypertensives . Following physician recommendation , 115 patients volunteered for a controlled trial to test the effectiveness of supplementary strategies to the pharmaceutical management of high blood pressure . A study of non participants indicated that about 7 % of the practice population was eligible for cardiovascular health education . One group received a health education program , a second was allocated to self-monitor their blood pressure for 6 months , a third group was allocated to both strategies , and the final group , acting as a control , continued to receive their usual care . Physician monitoring of patients continued for the duration of the study and blood pressures decreased in all patients . The study 's most important outcome was the joint reduction of blood pressure and medication strength . These were assessed by a " blind " clinician before and after the interventions according to criteria set out in the " stepped-care " approach to management of high blood pressure . People allocated to a health education program conducted in the doctor 's common room did twice as well on this measure as those who were not so educated . Daily self-monitoring of blood pressure for 6 months proved to be too much for the majority of those so instructed . It is concluded that the general practice setting remains an important place for health education to prevent cardiac disease and suggestions are made for incorporating this into everyday practice BACKGROUND Hypertension is a major risk factor for the long-term complications of diabetes . Mobile , self-measurement of blood pressure is emerging as a method to manage blood pressure in general , but its impact in patients with diabetes is unclear . METHODS We r and omized 137 patients with diabetes and hypertension to either mobile telemonitoring ( n = 72 ) or usual care ( n = 65 ) . Clinic blood pressure was recorded at baseline and after 6 months . Patients in the intervention arm transmitted weekly blood pressure readings wirelessly , using adapted sensors via mobile phones to a central server . Clinicians received the data in real-time and using a web-based application provided management advice to the patient and their physicians . RESULTS Systolic blood pressure fell significantly in the patients in the intervention group ( mean [ 95 % confidence interval ] , -6.5 [ -0.8 to -12.2 ] mm Hg ; P = 0.027 ) and remained unchanged in the control group ( 2.1 [ 9.3 to -5.0 ] mm Hg ; P = 0.57 ) . Patients within the intervention arm of African origin seemed to benefit more from the intervention . In addition , those who achieved a systolic blood pressure of < 120 mm Hg had lower average blood sugars than those with higher readings ( 7.8 [ SD 1.6 ] vs. 8.9 [ SD 2.2 ] mmol/L ; P = 0.02 ) . CONCLUSIONS In patients with diabetes , mobile telemonitoring has potential for delivering intensified care to improve blood pressure control , and its use may be associated with reduced exposure to hyperglycemia BACKGROUND The majority of hypertensive patients do not reach the target blood pressure ( BP ) . We sought to clarify whether intermittent self-monitoring of BP leads to better BP control compared to ordinary treatment in general practice . METHODS Two hundred sixty-nine hypertensive patients participated in this multicenter , r and omized , parallel-group study in primary health care . Home BP was measured in the self-monitoring ( SM ) group at 0 , 2 , 4 , and 6 months , and in the control ( C ) group at 0 and 6 months . The participating physicians were instructed to intensify the antihypertensive therapy when needed . RESULTS At the beginning , both groups had similar home BP levels ( SM 143.1 + /- 17.4/85.3 + /- 7.4 mm Hg v C 143.9 + /- 18.3/85.4 + /- 7.5 mm Hg ) . After 6 months , there were significant decreases in systolic ( P < or= .0001 ) , diastolic ( P < or= .0029 ) , and pulse pressures ( P < or= .021 ) in both groups . Systolic ( -7.8 + /- 13.1 mm Hg v -4.5 + /- 12.2 mm Hg , P = .047 ) and pulse pressure ( -4.7 + /- 9.0 mm Hg v -2.2 + /- 10.0 mm Hg , P = .042 ) decreased significantly more than in the self-monitoring group . The decrease in diastolic pressure was similar in both groups ( SM -3.1 + /- 6.2 mm Hg v C -2.3 + /- 8.3 mm Hg , P = not significant ) . The patients in the SM group reached home BP target more often than those in the C group ( 29 % v 16 % , P = .016 ) . There was a nonsignificant trend toward lower office BP values in the SM group . CONCLUSIONS Self-monitoring decreased systolic and pulse pressure significantly more than ordinary treatment and promoted achievement of target BP . This was most likely due to improved patient compliance and more active treatment by the physicians . Our results suggest that home measurement is useful in the control of hypertension Background : Nearly one in three adults in the United States has hypertension . Hypertension is one of the largest risk factors for cardiovascular diseases , and it is growing in prevalence , especially among African Americans . Objectives : To test the hypothesis that individuals who participate in usual care ( UC ) plus blood pressure ( BP ) telemonitoring ( TM ) will have a greater reduction in BP from baseline to 12-month follow-up than would individuals who receive UC only . Methods : A two-group , experimental , longitudinal design with block stratified r and omization for antihypertensive medication use was used . African Americans with hypertension were recruited through free BP screenings offered in the community . Data were collected through a structured interview and brief physical exam . Cross tabs , repeated measures analysis of variance , and independent t tests were used to analyze the study 's hypothesis . Results : The TM intervention group had a greater reduction in systolic BP ( 13.0 mm Hg ) than the enhanced UC group ( 7.5 mm Hg ; t = −2.09 , p = .04 ) from baseline to the 12-month follow-up . Although the TM intervention group had a greater reduction in diastolic BP ( 6.3 mm Hg ) compared with the enhanced UC group ( 4.1 mm Hg ) , the differences were not statistically significant ( t = −1.56 , p = .12 ) . Discussion : Telemonitoring of BP result ed in clinical ly and statistically significant reductions in systolic BP over a 12-month period ; if maintained over a longer period of time , the reductions could improve care and outcomes significantly for African Americans with hypertension Four compliance strategies were compared with education alone to investigate their impact on the control of high blood pressure . One hundred twelve subjects with documented high blood pressure were r and omly assigned to receive education alone , home blood pressure monitoring , contracts , pill packs , or a combination of techniques . Groups were similar in terms of age , sex , race , initial blood pressure , and medications . At the end of the year , there was no significant change in blood pressure for the group that received education alone ( -3/-1 mm Hg ) . There was a statistically significant change in both systolic and diastolic blood pressure for all compliance groups ( -17/-10 mm Hg ) . Information from compliance question naires adds further support to the observation that education alone does not influence compliance while the specific techniques studied did improve compliance . The study was too small to show any difference among techniques Background Poor adherence to treatment is one of the major problems in the treatment of hypertension . Self blood pressure measurement may help patients to improve their adherence to treatment . Method In this prospect i ve , r and omized , controlled study coordinated by a university hospital , a total of 228 mild-to-moderate hypertensive patients were r and omized to either a group that performed self- measurements at home in addition to office blood pressure measurements [ the self-pressure group ( n = 114 ) ] or a group that only underwent office blood pressure measurement [ the office pressure group ( n = 114 ) ] . Patients were followed for 1 year in which treatment was adjusted , if necessary , at each visit to the physician 's office according to the achieved blood pressure . Adherence to treatment was assessed by means of medication event monitoring system TrackCaps . Results Median adherence was slightly greater in patients from the self-pressure group than in those from the office pressure group ( 92.3 vs. 90.9 % ; P = 0.043 ) . Although identical among both groups , in the week directly after each visit to the physician 's office , adherence [ 71.4 % ( interquartile range 71–79 % ) ] was significantly lower ( P < 0.001 ) than that at the last 7 days prior to each visit [ 100 % ( interquartile range 90–100 % ) ] . On the remaining days between the visits , patients from the self-pressure group displayed a modestly better adherence than patients from the office pressure group ( 97.6 vs. 97.0 % ; P = 0.024 ) . Conclusion Although self-blood pressure measurement as an adjunct to office blood pressure measurement led to somewhat better adherence to treatment in this study , the difference was only small and not clinical ly significant . The time relative to a visit to the doctor seems to be a more important predictor of adherence OBJECTIVE Evaluation of a structured hypertension treatment and teaching programme in general practice . DESIGN Prospect i ve controlled trial ; follow-up period 18 months . SETTING 10 primary health care practice s. PRACTICE S AND PATIENTS : From each practice 20 patients ( 30 to 60 years old , mean of the last two blood pressure measurements at or above 160 and /or 95 mmHg ) were r and omly selected ; in 5 practice s these patients were to participate in the treatment and teaching programme ; in the remaining 5 practice s hypertension care was continued without the availability of such a programme ( controls ) . INTERVENTION Structured treatment and teaching programme based upon four group sessions for patients mainly conducted by paramedical personnel . MAIN OUTCOME MEASURES Blood pressure , body weight , prescription of antihypertensive drugs - as documented in the patient 's records . MAIN RESULTS Of the 100 control patients 26 and of the 100 intervention patients 14 were lost to observation ; 46 patients had agreed to participate in the programme . The mean number of prescribed antihypertensive agents per patient decreased in the intervention group ( 1.8 + /- 1.3 at baseline , vs 1.2 + /- 1.2 at follow-up ) compared to the control group ( 1.6 + /- 1.3 vs 1.8 + /- 1.6 ) ; difference 0.8 ( 95 % CI 0.4 to 1.1 ) , p < 0.0001 . In the control group 9 % and in the intervention group 33 % of patients had documented reductions of body weight ( p < 0.0001 ) . Blood pressure decreased in the intervention group ( 162 + /- 14/100 + /- 7 mmHg at baseline , vs 154 + /- 16/95 + /- 9 mmHg at follow-up ) compared to the control group ( 161 + /- 13/98 + /- 7 mmHg vs 158 + /- 18/96 + /- 11 mmHg ) ; differences for systolic blood pressure 5 ( 95 % CI 0 to 10 ) mmHg , p = 0.071 ; for diastolic blood pressure 4 ( 1 to 7 ) mmHg , p = 0.018 . CONCLUSIONS The introduction of a structured hypertension treatment and teaching programme in general practice may lead to significant improvements of hypertension care BACKGROUND To determine which of 3 interventions was most effective in improving blood pressure ( BP ) control , we performed a 4-arm r and omized trial with 18-month follow-up at the primary care clinics at a Veterans Affairs Medical Center . METHODS Eligible patients were r and omized to either usual care or 1 of 3 telephone-based intervention groups : ( 1 ) nurse-administered behavioral management , ( 2 ) nurse- and physician-administered medication management , or ( 3 ) a combination of both . Of the 1551 eligible patients , 593 individuals were r and omized ; 48 % were African American . The intervention telephone calls were triggered based on home BP values transmitted via telemonitoring devices . Behavioral management involved promotion of health behaviors . Medication management involved adjustment of medications by a study physician and nurse based on hypertension treatment guidelines . RESULTS The primary outcome was change in BP control measured at 6-month intervals over 18 months . Both the behavioral management and medication management alone showed significant improvements at 12 months-12.8 % ( 95 % confidence interval [ CI ] , 1.6%-24.1 % ) and 12.5 % ( 95 % CI , 1.3%-23.6 % ) , respectively-but not at 18 months . In subgroup analyses , among those with poor baseline BP control , systolic BP decreased in the combined intervention group by 14.8 mm Hg ( 95 % CI , -21.8 to -7.8 mm Hg ) at 12 months and 8.0 mm Hg ( 95 % CI , -15.5 to -0.5 mm Hg ) at 18 months , relative to usual care . CONCLUSIONS Overall intervention effects were moderate , but among individuals with poor BP control at baseline , the effects were larger . This study indicates the importance of identifying individuals most likely to benefit from potentially re source intensive programs . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00237692 This study aim ed to compare the efficacy of a patient-directed management strategy with office-based management in maintaining blood pressure control in patients with chronic stable hypertension using a r and omized trial of two months duration . The subjects had chronic stable essential hypertension without secondary causes or unstable cardiovascular disease and were selected through the offices of 11 family physicians and a tertiary care hypertension research unit . Patients were r and omly assigned ( 2:1 ratio ) to either a patient-directed management strategy using home blood pressure monitoring to adjust drug therapy if readings consistently exceeded defined limits , or office-based management through physician visits . The primary endpoint was the change from baseline in mean arterial pressure as determined by automatic ambulatory blood pressure monitoring . Secondary endpoints were changes in compliance , quality of life , and health care re source use . Ninety-one potential subjects were screened and 31 were r and omized . Subjects in the patient-directed management group employed the drug adjustment protocol s appropriately without complications . A significant difference in change in mean blood pressure was observed , favoring the patient-directed management ( -0.95 mm Hg and + 1.90 mm Hg , respectively , for patient-directed management and office-based management , P = .039 ) . Compliance rates and quality of life scores were not significantly different between groups . Physician visits were more frequent in the patient-directed management group ( 1.05 v 0.20 visits/8 weeks , respectively , for patient-directed management and office-based management groups , P = .045 ) . A patient-directed hypertensive management strategy may be feasible for patients with chronic stable hypertension . Such a strategy may improve blood pressure control compared with usual office-based care . However , physician visits may be increased using this strategy , at least in the short term OBJECTIVE To determine if a multimodal intervention composed of patient education , home blood pressure ( BP ) monitoring , BP measurement reporting to an interactive voice response ( IVR ) phone system , and clinical pharmacist follow-up improves BP control compared with usual care . STUDY DESIGN Prospect i ve study with patient enrollment , medication consultation and adjustment , remote BP monitoring , and follow-up at 6 months . METHODS This r and omized controlled trial was conducted at 3 healthcare systems in Denver , Colorado , including a large health maintenance organization , a Veterans Affairs medical center , and a county hospital . At each site , patients with uncontrolled BP were r and omized to the multimodal intervention vs usual care for 6 months , with the primary end point of BP reduction . RESULTS Of 338 patients r and omized , 283 ( 84 % ) completed the study , including 138 intervention patients and 145 usual care patients . Baseline BP was higher in the intervention group vs the usual care group ( 150.5/89.4 vs 143.8/85.3 mm Hg ) . At 6 months , BPs were similar in the intervention group vs the usual care group ( 137.4 vs 136.7 mm Hg , P = .85 for systolic ; 82.9 vs 81.1 mm Hg , P = .14 for diastolic ) . However , BP reductions were greater in the intervention group vs the usual care group ( −13.1 vs −7.1 mm Hg , P = .006 for systolic ; −6.5 vs −4.2 mm Hg , P = .07 for diastolic ) . Adherence to medications was similar between the 2 groups , but intervention patients had a greater increase in medication regimen intensity . CONCLUSIONS A multimodal intervention of patient education , home BP monitoring , BP measurement reporting to an IVR system , and clinical pharmacist follow-up achieved greater reductions in BP compared with usual care PURPOSE Home blood pressure ( BP ) monitoring is increasingly prevalent . The Canadian Hypertension Education Program ( CHEP ) developed a Family Practice BP tracking diary for home readings with an educational booklet . We evaluated the effectiveness of these tools compared with the st and ard approach of a hypertension information leaflet on BP-related knowledge , attitudes and behaviours of hypertensive family practice patients . METHOD Single-blind r and omized control trial on patients with raised BP . RESULTS Three practice s in Ontario , Quebec and Nova Scotia recruited a total of 109 eligible patients . The average age was 66.1 ( SD 9.3 ) years and 58 ( 54.7 % ) were male . There was a statistically significant increase in the mean number of correct responses to 20 hypertension knowledge questions of 1.14 from 15.3 ( SD 2.2 ) at baseline to 16.4 ( SD 2.2 ) at 3 months in both groups ( n=72 , P<0.001 ) . Patients frequently did not realize that usually more than one drug plus lifestyles changes were necessary to reduce BP to target or that it might take 6 weeks for some drugs to achieve their full effect . The BP tracking diary and the booklet had positive evaluation from the patients . CONCLUSIONS Most patients have a good baseline of knowledge about hypertension but there are still important areas that need to be addressed . The booklet and tracker were well received by patients but the simple leaflet was as effective at improving knowledge Abstract Effective antihypertensive care is not possible without regular and reliable blood pressure measurements . The use of blood pressure home measurement has increased a lot during the last years . Various methods have been used in communication between the patients and physicians . In a r and omized study we compared traditional office-based hypertension treatment protocol ( n=68 ) to the home-based blood pressure measurement protocol ( n=89 ) in which the patient mailed their home-measured BP diary in a letter to the office of their physician . The studied home-based antihypertensive care system was not more effective than the ordinary office-based treatment . The results highlight the importance of continuous home measurement data interpretation by the physician . The system based on mailing the results to the physician office does not seem to be a suitable method in communication between the patient and the physician . Online or other telemedicine-aided means of communication might yield better antihypertensive control This study was conducted to evaluate the effect of automated telephone patient monitoring and counseling on patient adherence to antihypertensive medications and on blood pressure control . A r and omized controlled trial was conducted in 29 greater Boston communities . The study subjects were 267 patients recruited from community sites who were > or= 60 years of age , on antihypertensive medication , with a systolic blood pressure ( SBP ) of > or= 160 mm Hg and /or a diastolic blood pressure ( DBP ) of > or= 90 mm Hg . The study compared subjects who received usual medical care with those who used a computer-controlled telephone system in addition to their usual medical care during a period of 6 months . Weekly , subjects in the telephone group reported self-measured blood pressures , knowledge and adherence to antihypertensive medication regimens , and medication side-effects . This information was sent to their physicians regularly . The main study outcome measures were change in antihypertensive medication adherence , SBP and DBP during 6 months , satisfaction of patient users , perceived utility for physicians , and cost-effectiveness . The mean age of the study population was 76.0 years ; 77 % were women ; 11 % were black . Mean antihypertensive medication adherence improved 17.7 % for telephone system users and 11.7 % for controls ( P = .03 ) . Mean DBP decreased 5.2 mm Hg in users compared to 0.8 mm Hg in controls ( P = .02 ) . Among nonadherent subjects , mean DBP decreased 6.0 mm Hg for telephone users , but increased 2.8 mm Hg for controls ( P = .01 ) . For telephone system users , mean DBP decreased more if their medication adherence improved ( P = .03 ) . The majority of telephone system users were satisfied with the system . Most physicians integrated it into their practice s. The system was cost-effective , especially for nonadherent patient users . Therefore , weekly use of an automated telephone system improved medication adherence and blood pressure control in hypertension patients . This system can be used to monitor patients with hypertension or with other chronic diseases , and is likely to improve health outcomes and reduce health services utilization and costs BACKGROUND African Americans have a higher prevalence and greater severity of hypertension than do other minorities and whites . This fact is particularly problematic when one realizes that the rate of control and treatment of hypertension in the US population is getting worse rather than better . Alternative strategies to promote blood pressure control need to be tested . OBJECTIVES The purpose of this pilot study was to test the following hypothesis : Persons who participate in nurse-managed home telemonitoring ( HT ) plus usual care or who participate in nurse-managed community-based monitoring ( CBM ) plus usual care will have greater improvement in blood pressure from baseline to 3 months ' follow-up than will persons who receive usual care only . METHODS This study used a r and omized controlled design ; participants were r and omly assigned to 1 of 3 groups that were stratified by use or nonuse of antihypertension medication . One-way analysis of variance ( ANOVA ) and analysis of covariance ( ANCOVA ) controlling for age and body weight were used to determine changes in blood pressure from baseline to 3 months . The sample contained 26 African Americans with a mean age of 59 years . RESULTS Both the HT group and the CBM group had clinical ly and statistically significant ( P < .05 ) drops in systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) at 3 months ' follow-up , with participants in the HT group demonstrating the greatest improvement ( HT : baseline SBP 148.8 + /- 13.8 , DBP 90.2 + /- 5.79 ; 3 months ' follow-up SBP 124.1 + /- 13.82 , DBP 75.58 + /- 11.4 ; CBM : baseline SBP 155.25 + /- 17.014 , DBP 89.42 + /- 10.95 ; 3 months ' follow-up SBP 142.3 + /- 12.1 , DBP 78.25 + /- 6.86 ) . There was little change in SBP or DBP at 3 months ' follow-up in the usual care only group . CONCLUSION These are important pilot results , which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension Background Rates of control of hypertension remain unsatisfactory worldwide and simple methods to encourage patients to adhere to treatments are still necessary . In this r and omized controlled trial , we evaluated the efficacy of a protocol of home blood pressure monitoring ( HBPM ) , without medication titration , to improve BP assessed by ambulatory BPM ( ABPM ) . Methods Patients with hypertension under drug treatment and with uncontrolled BP at office and by 24-h ABPM were r and omly assigned to HBPM or usual care . The treatment was not modified during the trial . Follow-up visits were conducted at 7 and 30 days after r and omization , and at 60 days to assess the outcome . Deltas between baseline and final ABPM measurements were calculated for 24-h , nightly and daily ambulatory SBP and DBP . Results Of 558 patients screened , 136 fulfilled the eligibility criteria and were r and omized , and 121 ( 89 % ) completed the trial . The between groups deltas ( 95 % confidence interval ) of variation of 24 h , nightly and daily SBP were 5.4 ( 0.9–9.8 ) ( P = 0.018 ) , 10.9 ( 2.9–18.9 ) ( P = 0.012 ) and 4.4 mmHg ( −0.1 to 8.8 ) ( P = 0.055 ) , respectively ; the corresponding deltas for DBP were 4.5 ( 1.6–7.4 ) ( P = 0.003 ) , 3.4 ( 0.4–6.3 ) ( P = 0.025 ) and 5.8 mmHg ( 2.5–9.0 ) ( P = 0.001 ) , respectively . At the end of the trial , 32.4 % of patients of the HBPM groups and 16.2 % of the control group had 24-h SBP less than 130/80 mmHg ( P = 0.03 ) . Conclusion A protocol of HBPM without medication titration enhances the control of BP assessed by ABPM Blood pressure self-measurement is increasing in most communities and yet its role in the management of hypertension is poorly understood . This study was devised to evaluate the behaviour of doctors in general practice when treating patients with poorly controlled essential hypertension who use self-measurement . Patients , most of whom were already taking antihypertensive medications were commenced on perindopril or indapamide at their doctor ’s discretion and were r and omly allocated to self-measurement ( SM ) using an OMRON HEM706 oscillometric device or a continuation of their usual care ( UC ) over an 8-week period . This was an observational study without any specific or set treatment goals for the doctor to follow . Sixty of 62 subjects completed the study and the two groups were equally matched for age , body mass index , gender , and blood pressure ( BP ) . While additional perindopril or indapamide produced a significant fall in BP in both groups over the study period , the systolic pressure remained significantly higher in the SM group ( sitting 148 ± 3 compared with 142 ± 3 ; 145 ± 3 compared with 138 ± 3 mm Hg respectively ; P < 0.05 ) . twenty-four hour and daytime ambulatory monitor systolic pressures were also significantly higher in the sm group . differences in diastolic bp were not statistically significant . furthermore , sm patients were less likely to have their medications increased and more likely to have them reduced or ceased . doctors and patients found self-measurement convenient and useful . this study suggests that doctors prescribing decisions are influenced by evidence from self-measurement of bp with consequential increases in office bp related to reduced drug use . while self-bp measurement can offer reassurance about adequacy of control when away from a physicians office , our best evidence of underst and ing target blood pressures comes from large r and omised studies using office blood pressures as an end-point . there is an urgent need for further study to provide arbitration between self-measurement and office blood pressures although each measurement must contribute to the management of hypertension BACKGROUND The measurement of blood pressure ( BP ) by the patient himself without strict protocol s , adequate training , and vali date d equipment at their own household is defined as self measured blood pressure ( SMBP ) . OBJECTIVE To evaluate the interference of the SMBP in treatment adherence and blood pressure control . METHODS The study included 57 patients , 38 in the study group ( SG ) and 19 in the control group ( CG ) . These patients were followed for 12 months and assessed at r and omization ( V1 ) as well as in the sixth ( V2 ) and the twelfth month ( V3 ) . Compare the mean blood pressure by casual measurement , by SMBP and by ambulatory monitoring of blood pressure ( AMBP ) , laboratory tests and the answers to the question naire on lifestyle . The instruments used were : OMRON HEM 714 , for SMBP ; OMRON 705 CP , for the casual measurement , and Monitor SPACELABS 9002 for the AMBP . RESULTS The average age was 62.05 ± 10.78 in the SG and 55.42 ± 11.87 in the CG ( p = 0.03 ) . The values of systolic blood pressure ( SBP ) by casual measurement in the SG and CG were : 140.01 ± 16.73 mmHg and 141.79 ± 23.21 mmHg in V1 ( p = 0.72 ) , 135.49 ± 12.73 mmHg and 145.69 ± 19.31 mmHg in V2 ( p = 0.02 ) , 131.64 ± 19.28 mmHg and 134.88 ± 23.21 mmHg at V3 ( p = 0.59 ) . The values of diastolic blood pressure ( DBP ) were : 84.13 ± 10.71 mmHg and 86.29 ± 10.35 mmHg in V1 ( p = 0.47 ) , 81.69 ± 10.88 mmHg and 89.61 V2 ± 11.58 mmHg ( p = 0.02 ) , 80.31 ± 11.83 mmHg and 86 ± 13.38 mmHg in V3 ( p = 0.12 ) . CONCLUSION Patients in the SG had adherence to non-pharmacological treatment similar to the CG , but they had greater adherence to drug treatment and used fewer antihypertensive drugs . There was no difference between groups when comparing the metabolic profile and renal function The objective of this study was to determine whether a hypertension management program in which patients monitor their own blood pressure ( BF ) at home can reduce costs without compromising BP control . The prospect i ve , r and omized , controlled 1-year clinical trial was conducted at four medical centers of the Kaiser Permanente Medical Care Program in the San Francisco Bay Area . Of 467 patients with uncomplicated hypertension who were referred by their physicians , 37 declined to participate in the study ; 215 were r and omly assigned to a Usual Care ( UC ) group and 215 to a Home BP group . Twenty-five UC patients and 15 Home BP patients did not return for year-end BP measurements . Patients in the UC group were referred back to their physicians . Patients in the Home BP group were trained to measure their own BP and return the readings by mail . Patients were given a st and ard procedure to follow in case of unusually high or low BP readings at home . The number and type of outpatient medical services used were obtained from patient medical records for the study year and the prior year . Costs of care for hypertension were calculated by assigning relative value units to each outpatient service . Trained technicians measured each patient 's BP at entry into the study and 1 year later . Home BP patients made 1.2 fewer hypertension-related office visits than UC patients during the study year ( 95 % confidence interval ( CI ) : 0.8,1.7 ) . Mean adjusted cost for physician visits , telephone calls , and laboratory tests associated with hypertension care was $ 88.76 per patient per year in the Home BP group , 29 % less than in the UC group ( 95 % CI : $ 16.11 , $ 54.74 ) . The annualized cost of implementing the home BP system was approximately $ 28 per patient during the study year and would currently be approximately $ 15 . After 1 year , BP control in men in the Home BP group was better than in men in the UC group ; BP control was equally good in women in both groups . Management of uncomplicated hypertension based on periodic home BP reports can achieve BP control with fewer physician visits , result ing in substantial cost savings Background Self blood pressure monitoring at home may improve blood pressure control and patients ' compliance with treatment , but its implementation in daily practice faces difficulties . Teletransmission facilities may offer a more efficient approach to long-term home blood pressure monitoring . Methods Twelve general practitioners screened 391 consecutive uncontrolled mild – moderate hypertensive patients ( 80 % treated ) , 329 of whom ( 58 ± 11 years , 54 % men ) were r and omized to either usual care on the basis of office blood pressure ( group A , n = 113 ) or to integrated care on the basis of teletransmitted home blood pressure ( group B , n = 216 ) . Twenty-four-hour ambulatory blood pressure monitoring was performed at baseline and after 6 months , during which treatment was optimized according to either office ( group A ) or home ( group B ) blood pressure values . We compared differences between groups in the rate of daytime ambulatory blood pressure normalization ( < 130/80 mmHg ) , need of treatment changes during follow-up , quality of life scores , and healthcare costs . Results Baseline office blood pressures were 149 ± 12/89 ± 9 and 148 ± 13/89 ± 7 mmHg in groups A ( n = 111 ) and B ( n = 187 ) respectively , the corresponding daytime values being 140 ± 11/84 ± 8 and 139 ± 11/84 ± 8 mmHg . The percentage of daytime blood pressure normalization was higher in group B ( 62 % ) than in group A ( 50 % ) ( P < 0.05 ) . There were less frequent treatment changes in group B than in group A ( 9 vs. 14 % , P < 0.05 ) . Quality of life tended to be higher and costs lower in group B. Conclusion Patients ' management based on home blood pressure teletransmission led to a better control of ambulatory blood pressure than with usual care , with a more regular treatment regimen The effects of self-monitoring of blood pressure on the control of hypertension were examined in this study . Failure of patients to comply with treatment is presumably attributable in part to the fact that hypertension usually is asymptomatic until complications develop . Self-monitoring might make visible an otherwise asymptomatic condition , and thereby increase motivation . One hundred hypertensive patients beginning outpatient treatment were r and omly assigned to experimental and control groups . Subjects were given a sphygmomanometer and instructed in its use . Both groups were given similar antihypertensive medications . After six months of treatment , mean systolic pressure was significantly lower ( 11.4 mm Hg , p<0.05 ) in the experimental than in the control subjects . However , the mean baseline systolic pressure in the control group was 3.9 mm Hg less than that of the experimental group . If this value is subtracted from the difference between the last mean systolic pressures in the two groups , the 7.5 mm Hg difference is seen as a very modest effect of self-monitoring . Diastolic blood pressure was insignificantly lower for experimental subjects . Compared to the potent effectiveness of drugs in reducing blood pressure , self-monitoring was of little value Objective To evaluate whether patient‐measured home blood pressures alone can be used to manage hypertension in adults 65 years and older . Methods 40 hypertensive men and women , average age 73 ± 6 years , were r and omly assigned to one of two treatment decision groups . The ‘ home ’ group ( N = 20 ) had blood pressure managed and medication changed according to measurements taken by the patient at home with the Omron HEM‐702 semi‐automatic oscillometric digital blood pressure monitor and the ‘ clinic ’ group ( N = 20 ) had medication adjusted based upon readings taken by the project nurse in the clinic . In both groups , treated hypertensives had medications adjusted downward , while untreated hypertensives were started on a diuretic and /or ACE inhibitor and adjustments were made upward . To assess the efficacy of the home measurements as a means of hypertension management , 24‐hour ambulatory blood pressure averages , quality of life ( From the QOL SF‐36 ) , and dosage of antihypertensive medications were compared between the home and clinic groups over a three‐month period . Results At baseline , the ‘ home ’ group had slightly higher ambulatory awake and sleep blood pressure than the ‘ clinic ’ group . At 3 months , the average awake and sleep ambulatory blood pressure for the ‘ home ’ group decreased to the level of the ‘ clinic ’ group . Values of the ‘ clinic ’ group did not change . In both groups , pressures of previously treated patients increased over the 3 months , while those that were previously untreated declined . However , this difference , to some extent , might be expected because the acceptable limit of pressure control ( 150 / 90 mmHg ) was higher than many of the patients on medications ; thus , their pressures could increase and still be considered controlled . Those patients who were previously untreated had their pressures decreased only to this level . The nurse‐measured clinic blood pressures for the ‘ home ’ group began higher than that of the ‘ clinic ’ group and remained higher at the end of the study . Average home pressures of the ‘ home ’ group were consistently lower than nurse‐measured clinic pressures over the 3‐month study period , indicating a persistent ‘ white coat ’ effect . Both groups had similar changes in total quality of life scores . Decrease/discontinuance of antihypertensive medication was also achieved equally in both groups at the end of 3 months . Conclusion Home blood pressure monitoring alone may be as useful as clinic measurements for making treatment decisions in the elderly Objective : To determine the prognosis of treated hypertensive type 1 ( insulin-dependent ) diabetic patients with overt nephropathy . Design : A controlled , prospect i ve , parallel , 5-year follow-up trial . Setting : The tertiary care centre of the Heinrich Heine University Hospital in Dusseldorf , Germany . Patients and interventions : A sequential sample of 91 hypertensive patients with overt diabetic nephropathy participated in a diabetes treatment programme . Thereafter 45 patients received intensified antihypertensive therapy including blood pressure self-monitoring and self-adjustment of antihypertensive drug treatment with the goal of permanent normalization of blood pressure values below 140/90 mmHg . The remaining 46 patients were administered routine antihypertensive therapy and formed the control group . At baseline both groups were comparable in age , sex , metabolic control and renal function . The groups differed at baseline in their duration of diabetes and blood pressure values , which were higher in the intensified antihypertensive therapy group . Outcome measures : Total mortality and the need for renal replacement therapy . Main results : Blood pressure control was significantly improved in patients who were subjected to intensified antihypertensive therapy , whereas it deteriorated in the group of patients who received routine antihypertensive therapy . At follow-up , primary end points of the study occurred in five ( 11 % ) patients of the intensified therapy group and in 19 ( 41 % ) patients of the routine therapy group . According to life table analysis , intensified antihypertensive therapy was associated with less frequent primary end points ( P= 0.0058 ) and longer survival ( P=0.01 ) . The differences between the groups remained significant after adjustment for covariates in the proportional hazards model . Conclusion : Participation in a treatment programme aim ed at intensification of antihypertensive therapy is associated with a reduction of mortality in hypertensive type 1 diabetic patients with overt nephropathy Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness . We conducted a r and omized controlled trial comparing telemedicine case management to usual care , with blinding of those obtaining outcome data , in 1,665 Medicare recipients with diabetes , aged 55 years or greater , and living in federally design ated medically underserved areas of New York State . In New York City , 98 % of participants were black or Hispanic , 69 % were Medicaid-eligible , and 93 % reported annual household income < or = $ 20,000 . In upstate New York , 91 % were white , 14 % Medicaid eligible , and 50 % reported annual household income < or = $ 20,000 . A baseline survey found that 95 % of participants in New York City and 67 % in upstate New York reported that they did not know how to use a computer . The primary endpoints were HgbA1c , blood pressure , and low density lipoprotein ( LDL ) cholesterol levels . In the intervention group ( N = 844 ) , mean HgbA1c improved over 1 year from 7.35 % to 6.97 % , and from 8.35 % to 7.42 % in the subgroup with baseline HgbA1c > or = 7 % ( N = 353 ) . In the usual care group ( N = 821 ) , mean HgbA1c improved over 1 year from 7.42 % to 7.17 % . Adjusted net reductions ( 1-year minus baseline mean values in each group , compared between groups ) favoring the intervention were as follows : HgbA1c , 0.18 % ( p = 0.006 ) , systolic and diastolic blood pressure , 3.4 ( p = 0.001 ) and 1.9 mmHg ( p < 0.001 ) , and LDL cholesterol , 9.5 mg/dl ( p < 0.001 ) . In the subgroup with baseline HgbA1c > or = 7 % , net adjusted reduction in HgbA1c favoring the intervention group was 0.32 % ( p = 0.002 ) . Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dl . The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York . A satisfaction survey of intervention group participants ( N = 346 respondents ) showed high levels of satisfaction with major intervention components . A satisfaction survey of participating primary care physicians ( N = 116 respondents ) showed positive perceptions for acceptability , impact on patients and communication . Telemedicine case management improved glycemic control , blood pressure levels , and total and LDL-cholesterol levels at 1 year of follow-up . Telemedicine is an effective method for translating modern approaches to disease management into effective care for underserved population Objective To evaluate the efficacy of a programme of home blood pressure measurement ( HBPM ) on therapeutic compliance in mild-to-moderate hypertension . Design A prospect i ve controlled multicentre clinical trial . Setting Forty primary care centres in Spain , with a duration of 6 months . Patients A total of 250 patients with newly diagnosed or uncontrolled hypertension were included . Interventions The patients were r and omly selected and distributed in two groups : ( 1 ) the control group ( CG ) who received st and ard health intervention ; ( 2 ) the intervention group ( IG ) : the patients in this group received an OMRON in their homes for a programme of HBPM . Main outcome measure Four visits were scheduled , for the measurement of blood pressure ( BP ) . They were provided with an electronic monitor for measuring compliance ( monitoring events medication system ; MEMS ) . Therapeutic compliance was defined as a drug consumption of 80–110 % . A number of variables were calculated using the MEMS . The mean BP were calculated and the percentage of controlled patients . Results A total of 200 patients completed the study ( 100 in each group ) . Compliance was observed in 74 and 92 % , respectively , in the CG and IG [ 95 % confidence interval ( CI ) 63.9–84.1 and 86.7–97.3 ; P = 0.0001 ] , the mean percentage compliances were 87.6 and 93.5 % ( 95 % CI 81.2–94 and 80.7–98.3 ; P = 0.0001 ) , the percentages of correct days were 83.6 and 89.4 % , the percentages of subjects who took the medication at the prescribed time were 79.89 and 88.06 % , and the levels of therapeutic cover were 86.7 and 93.1 % . The number needed to treat to avoid one case of non-compliance was 5.6 patients . The differences in the mean decreases in BP were significant for diastolic BP , with a greater decrease observed in the IG . Conclusions An HBPM programme using electronic monitors is effective in improving compliance in arterial hypertension , measured using the MEMS In a primary -care based study , 122 patients who were taking antihypertensive drugs took part in a two-year trial that aim ed at establishing the feasibility of non-pharmacological methods in the treatment of hypertension in general practice . The patients could choose from among 14 non-pharmacological methods of blood pressure reduction . Increased physical exercise ; weight reduction , low-sodium and low-fat diet , relaxation training , and home-monitoring of blood pressure were the most popular methods . The use of anti-hypertensive drugs was reduced by 55 % in the participants , with the defined daily dose ( DDD ) being lowered from 1.18 to 0.55 ( P less than 0.001 ) . At the end of the study , 46 % of the participants were free from anti-hypertensive drugs . Significant reductions occurred in body mass index ( 27.1 to 26.4 kg/m2 , P = 0.001 ) and serum cholesterol ( 6.89 to 6.48 mmol/l , P less than 0.001 ) . According to some measures used , the study group 's experience of " quality of life " was not reduced The effectiveness of two social support strategies design ed to lower hypertensive patients ' blood pressure were compared to each other and to a control group ( N = 63 ) receiving routine care in a r and omized clinical trial extending over a period of two years . Group 1 ( N = 99 ) received visits and had family members actively participate in their care through home blood pressure monitoring ; Group 2 ( N = 56 ) received home visits from nurses and pharmacists . All groups were predominantly Black . After the first year of the trial , the proportion of patients with uncontrolled diastolic blood pressure ( greater than or equal to 95 mm Hg ) had declined significantly for all three groups ; no group showed a statistically significant advantage . However , during the last six months of the second year ( after visiting had ended ) , both Groups 1 and 2 demonstrated clear superiority in DBP control over Group 3 , achieving borderline statistical significance ( p = .07 ) when multivariable analysis was performed to control for potential confounders . Supplementing routine care with periodic home visits produced an additional 21 per cent of patients with well-controlled DBP , while involving family members plus visits produced a 17 per cent improvement in the percentage of patients with DBP less than 95 mm Hg . However , neither support strategy was clearly more effective than the other over time . The efficacy of the interventions is discussed with respect to cost and feasibility of implementation Abstract Aims . The purpose of the present study was to compare the costs of home blood pressure ( BP ) telemonitoring ( HBPM ) with the costs of conventional office BP monitoring . In a r and omized controlled trial , 105 hypertensive patients performed HBPM and 118 patients received usual care with conventional office BP monitoring during 6 months . Costs were quantified from the healthcare perspective . Non-parametric simulations were performed to quantify the uncertainty around the mean estimates and cost-effectiveness acceptability curves were made . Major findings . Systolic and diastolic daytime and night-time ambulatory BP ( ABP ) were reduced in both groups . The uncertainty around the incremental cost effectiveness ratio point estimates was considerable for both systolic and diastolic ABP . For systolic ABP , the difference in cost effectiveness ratio between the two groups was 256 Danish kroner (DKK)/mmHg [ 95 % uncertainty interval , UI −860 to 4544 ] . For diastolic ABP , the difference in cost effectiveness ratio between the two groups was 655 DKK/mmHg [ 95 % UI −674 to 69315 ] . Medication and consultation costs were lowest in the intervention group , but were offset by the cost of the telemonitoring equipment . Conclusions . Cost-effectiveness analysis showed that telemonitoring of home BP was more costly compared with usual monitoring of office BP . The cost-effectiveness result is surrounded with considerable uncertainty . Trial registration : Clinical Trials.gov identifier : NCT282334 CONTEXT Treating hypertension decreases mortality and disability from cardiovascular disease , but most hypertension remains inadequately controlled . OBJECTIVE To determine if a new model of care that uses patient Web services , home blood pressure ( BP ) monitoring , and pharmacist-assisted care improves BP control . DESIGN , SETTING , AND PARTICIPANTS A 3-group r and omized controlled trial , the Electronic Communications and Home Blood Pressure Monitoring study was based on the Chronic Care Model . The trial was conducted at an integrated group practice in Washington state , enrolling 778 participants aged 25 to 75 years with uncontrolled essential hypertension and Internet access . Care was delivered over a secure patient Web site from June 2005 to December 2007 . INTERVENTIONS Participants were r and omly assigned to usual care , home BP monitoring and secure patient Web site training only , or home BP monitoring and secure patient Web site training plus pharmacist care management delivered through Web communications . MAIN OUTCOME MEASURES Percentage of patients with controlled BP ( < 140/90 mm Hg ) and changes in systolic and diastolic BP at 12 months . RESULTS Of 778 patients , 730 ( 94 % ) completed the 1-year follow-up visit . Patients assigned to the home BP monitoring and Web training only group had a nonsignificant increase in the percentage of patients with controlled BP ( < 140/90 mm Hg ) compared with usual care ( 36 % [ 95 % confidence interval { CI } , 30%-42 % ] vs 31 % [ 95 % CI , 25%-37 % ] ; P = .21 ) . Adding Web-based pharmacist care to home BP monitoring and Web training significantly increased the percentage of patients with controlled BP ( 56 % ; 95 % CI , 49%-62 % ) compared with usual care ( P < .001 ) and home BP monitoring and Web training only ( P < .001 ) . Systolic BP was decreased stepwise from usual care to home BP monitoring and Web training only to home BP monitoring and Web training plus pharmacist care . Diastolic BP was decreased only in the pharmacist care group compared with both the usual care and home BP monitoring and Web training only groups . Compared with usual care , the patients who had baseline systolic BP of 160 mm Hg or higher and received home BP monitoring and Web training plus pharmacist care had a greater net reduction in systolic BP ( -13.2 mm Hg [ 95 % CI , -19.2 to -7.1 ] ; P < .001 ) and diastolic BP ( -4.6 mm Hg [ 95 % CI , -8.0 to -1.2 ] ; P < .001 ) , and improved BP control ( relative risk , 3.32 [ 95 % CI , 1.86 to 5.94 ] ; P<.001 ) . CONCLUSION Pharmacist care management delivered through secure patient Web communications improved BP control in patients with hypertension . Trial Registration clinical trials.gov Identifier : NCT00158639 |
1,381 | 32,300,279 | Age , tumor location , tumor size/volume , and histologic response carried independent prognostic value in the majority of the studies . | Aim To investigate prognostic factors in pediatric and young adult patients with localized osteosarcoma that could predict the development of subsequent pulmonary metastases and lead to an ability to risk-stratify therapy .
We performed a systematic review of the literature published since January 1990 to establish common evidence -based prognostic factors . | Summary Background We design ed the EURAMOS-1 trial to investigate whether intensified postoperative chemotherapy for patients whose tumour showed a poor response to preoperative chemotherapy ( ≥10 % viable tumour ) improved event-free survival in patients with high- grade osteosarcoma . Methods EURAMOS-1 was an open-label , international , phase 3 r and omised , controlled trial . Consenting patients with newly diagnosed , resectable , high- grade osteosarcoma aged 40 years or younger were eligible for r and omisation . Patients were r and omly assigned ( 1:1 ) to receive either postoperative cisplatin , doxorubicin , and methotrexate ( MAP ) or MAP plus ifosfamide and etoposide ( MAPIE ) using concealed permuted blocks with three stratification factors : trial group ; location of tumour ( proximal femur or proximal humerus vs other limb vs axial skeleton ) ; and presence of metastases ( no vs yes or possible ) . The MAP regimen consisted of cisplatin 120 mg/m2 , doxorubicin 37·5 mg/m2 per day on days 1 and 2 ( on weeks 1 and 6 ) followed 3 weeks later by high-dose methotrexate 12 g/m2 over 4 h. The MAPIE regimen consisted of MAP as a base regimen , with the addition of high-dose ifosfamide ( 14 g/m2 ) at 2·8 g/m2 per day with equidose mesna uroprotection , followed by etoposide 100 mg/m2 per day over 1 h on days 1–5 . The primary outcome measure was event-free survival measured in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT00134030 . Findings Between April 14 , 2005 , and June 30 , 2011 , 2260 patients were registered from 325 sites in 17 countries . 618 patients with poor response were r and omly assigned ; 310 to receive MAP and 308 to receive MAPIE . Median follow-up was 62·1 months ( IQR 46·6–76·6 ) ; 62·3 months ( IQR 46·9–77·1 ) for the MAP group and 61·1 months ( IQR 46·5–75·3 ) for the MAPIE group . 307 event-free survival events were reported ( 153 in the MAP group vs 154 in the MAPIE group ) . 193 deaths were reported ( 101 in the MAP group vs 92 in the MAPIE group ) . Event-free survival did not differ between treatment groups ( hazard ratio [ HR ] 0·98 [ 95 % CI 0·78–1·23 ] ) ; hazards were non-proportional ( p=0·0003 ) . The most common grade 3–4 adverse events were neutropenia ( 268 [ 89 % ] patients in MAP vs 268 [ 90 % ] in MAPIE ) , thrombocytopenia ( 231 [ 78 % in MAP vs 248 [ 83 % ] in MAPIE ) , and febrile neutropenia without documented infection ( 149 [ 50 % ] in MAP vs 217 [ 73 % ] in MAPIE ) . MAPIE was associated with more frequent grade 4 non-haematological toxicity than MAP ( 35 [ 12 % ] of 301 in the MAP group vs 71 [ 24 % ] of 298 in the MAPIE group ) . Two patients died during postoperative therapy , one from infection ( although their absolute neutrophil count was normal ) , which was definitely related to their MAP treatment ( specifically doxorubicin and cisplatin ) , and one from left ventricular systolic dysfunction , which was probably related to MAPIE treatment ( specifically doxorubicin ) . One suspected unexpected serious adverse reaction was reported in the MAP group : bone marrow infa rct ion due to methotrexate . Interpretation EURAMOS-1 results do not support the addition of ifosfamide and etoposide to postoperative chemotherapy in patients with poorly responding osteosarcoma because its administration was associated with increased toxicity without improving event-free survival . The results define st and ard of care for this population . New strategies are required to improve outcomes in this setting . Funding UK Medical Research Council , National Cancer Institute , European Science Foundation , St Anna Kinderkrebsforschung , Fonds National de la Recherche Scientifique , Fonds voor Wetenschappelijk Onderzoek-Vla and eren , Parents Organization , Danish Medical Research Council , Academy of Finl and , Deutsche Forschungsgemeinschaft , Deutsche Krebshilfe , Federal Ministry of Education and Research , Semmelweis Foundation , ZonMw ( Council for Medical Research ) , Research Council of Norway , Sc and inavian Sarcoma Group , Swiss Paediatric Oncology Group , Cancer Research UK , National Institute for Health Research , University College London Hospitals , and Biomedical Research Centre The case histories of all patients with osteosarcoma of the trunk entered into the consecutive studies COSS 80 through COSS 86 of the Cooperative German/Austrian Osteosarcoma Study Group ( COSS ) were analyzed in order to evaluate their clinical characteristics and the impact of modern neoadjuvant therapy on prognosis . They were compared to those of all patients with extremity osteosarcoma treated according to the same protocol s. While tumors of the trunk comprised only 32 ( 4.8 % ) of 665 primary classical osteosarcomas , secondary osteosarcomas were much more likely to be located in bones of the axial skeleton ( 6 of 18 , 33 % ) . Patients with primary osteosarcoma of the axial skeleton were older ( mean : 20.8 vs. 15.2 years , P < 0.01 ) and were more likely to present with metastases at diagnosis ( 34 % vs 12 % , P < 0.001 ) than those with primary extremity osteosarcoma . In contrast to extremity tumors , local surgical treatment failure was very common in osteosarcomas of the trunk . Complete tumor removal was achieved in less than half of all evaluable cases . The prognosis of eight patients with localized primary axial osteosarcoma and effective surgical local control was not inferior to that of 483 equally evaluable patients with extremity tumors . In conclusion , while secondary systemic spread of axial osteosarcoma may be avoided in patients treated with multiagent chemotherapy , successful treatment is often barred by primary metastatic disease and inability to control the local tumor site PURPOSE To determine whether the addition of ifosfamide and /or muramyl tripeptide ( MTP ) encapsulated in liposomes to cisplatin , doxorubicin , and high-dose methotrexate ( HDMTX ) could improve the probability for event-free survival ( EFS ) in newly diagnosed patients with osteosarcoma ( OS ) . PATIENTS AND METHODS Six hundred seventy-seven patients with OS without clinical ly detectable metastatic disease were treated with one of four prospect ively r and omized treatments . All patients received identical cumulative doses of cisplatin , doxorubicin , and HDMTX and underwent definitive surgical resection of the primary tumor . Patients were r and omly assigned to receive or not to receive ifosfamide and /or MTP in a 2 double dagger 2 factorial design . The primary end point for analysis was EFS . RESULTS Patients treated with the st and ard arm of therapy had a 3-year EFS of 71 % . We could not analyze the results by factorial design because we observed an interaction between the addition of ifosfamide and the addition of MTP . The addition of MTP to st and ard chemotherapy achieved a 3-year EFS rate of 68 % . The addition of ifosfamide to st and ard chemotherapy achieved a 3-year EFS rate of 61 % . The addition of both ifosfamide and MTP result ed in a 3-year EFS rate of 78 % . CONCLUSION The addition of ifosfamide in this dose schedule to st and ard chemotherapy did not enhance EFS . The addition of MTP to chemotherapy might improve EFS , but additional clinical and laboratory investigation will be necessary to explain the interaction between ifosfamide and MTP We conducted a r and omized controlled trial to determine whether intensive multi-agent adjuvant chemotherapy improves the chances of relapse-free survival in patients with nonmetastatic high- grade osteosarcoma of the extremity , as compared with concurrent controls . After undergoing definitive surgery , 36 patients were r and omly assigned to adjuvant chemotherapy or to observation without adjuvant treatment . At two years the actuarial relapse-free survival was 17 percent in the control group , similar to that found in studies before 1970 , and 66 percent in the adjuvant-chemotherapy group ( P less than 0.001 ) . Similar results were observed among 77 additional patients who declined to undergo r and omization but who elected observation or chemotherapy . We conclude that the natural history of osteosarcoma of the extremity has remained stable over the past two decades , that adjuvant chemotherapy increases the chances of relapse-free survival of patients with high- grade osteosarcoma , and that it should be given to all such patients PURPOSE To define prognostic factors for response and long-term outcome for a wide spectrum of osteosarcomas , extending well beyond those of the typical young patient with seemingly localized extremity disease . PATIENTS AND METHODS A total of 1,702 consecutive newly diagnosed patients with high- grade osteosarcoma of the trunk or limbs registered into the neoadjuvant studies of the Cooperative Osteosarcoma Study Group before July 1998 were entered into an analysis of demographic , tumor-related , and treatment-related variables , response , and survival . The intended therapeutic strategy included preoperative and postoperative chemotherapy with multiple agents as well as surgery of all operable lesions . RESULTS Axial tumor site , male sex , and a long history of symptoms were associated with poor response to chemotherapy in univariate and multivariate analysis . Actuarial 10-year overall and event-free survival rates were 59.8 % and 48.9 % . Among the variables assessable at diagnosis , patient age ( actuarial 10-year survival > or = 40 , 41.6 % ; < 40 , 60.2 % ; P = .012 ) , tumor site ( axial , 29.2 % ; limb , 61.7 % ; P < .0001 ) , and primary metastases ( yes , 26.7 % ; no , 64.4 % ; P < .0001 ) , and for extremity osteosarcomas , also size ( > or = one third , 52.5 % ; < one third , 66.7 % ; P < .0001 ) and location within the limb ( proximal , 49.3 % ; other , 63.9 % ; P < .0001 ) , had significant influence on outcome . Two additional important prognostic factors were treatment related : response to chemotherapy ( poor , 47.2 % ; good , 73.4 % ; P < .0001 ) and the extent of surgery ( incomplete , 14.6 % ; macroscopically complete , 64.8 % ; P < .0001 ) . All factors except age maintained their significance in multivariate testing , with surgical remission and histologic response emerging as the key prognostic factors . CONCLUSION Tumor site and size , primary metastases , response to chemotherapy , and surgical remission are of independent prognostic value in osteosarcoma Background High- grade osteosarcoma is a primary malignant bone tumour mainly affecting children and young adults . The European and American Osteosarcoma Study (EURAMOS)-1 is a collaboration of four study groups aim ing to improve outcomes of this rare disease by facilitating r and omised controlled trials . Methods Patients eligible for EURAMOS-1 were aged ≤40 years with M0 or M1 skeletal high- grade osteosarcoma in which case complete surgical resection at all sites was deemed to be possible . A three-drug combination with methotrexate , doxorubicin and cisplatin was defined as st and ard chemotherapy , and between April 2005 and June 2011 , 2260 patients were registered . We report survival outcomes and prognostic factors in the full cohort of registered patients . Results For all registered patients at a median follow-up of 54 months ( interquartile range : 38–73 ) from biopsy , 3-year and 5-year event-free survival were 59 % ( 95 % confidence interval [ CI ] : 57–61 % ) and 54 % ( 95 % CI : 52–56 % ) , respectively . Multivariate analyses showed that the most adverse factors at diagnosis were pulmonary metastases ( hazard ratio [ HR ] = 2.34 , 95 % CI : 1.95–2.81 ) , non-pulmonary metastases ( HR = 1.94 , 95 % CI : 1.38–2.73 ) or an axial skeleton tumour site ( HR = 1.53 , 95 % CI : 1.10–2.13 ) . The histological subtypes telangiectatic ( HR = 0.52 , 95 % CI : 0.33–0.80 ) and unspecified conventional ( HR = 0.67 , 95 % CI : 0.52–0.88 ) were associated with a favourable prognosis compared with chondroblastic subtype . The 3-year and 5-year overall survival from biopsy were 79 % ( 95 % CI : 77–81 % ) and 71 % ( 95 % CI : 68–73 % ) , respectively . For patients with localised disease at presentation and in complete remission after surgery , having a poor histological response was associated with worse outcome after surgery ( HR = 2.13 , 95 % CI : 1.76–2.58 ) . In radically operated patients , there was no good evidence that axial tumour site was associated with worse outcome . Conclusions In conclusion , data from > 2000 patients registered to EURAMOS-1 demonstrated survival rates in concordance with institution- or group-level osteosarcoma trials . Further efforts are required to drive improvements for patients who can be identified to be at higher risk of adverse outcome . This trial reaffirms known prognostic factors , and owing to the large numbers of patients registered , it sheds light on some additional factors to consider |
1,382 | 20,030,832 | With few exceptions , the findings showed that quality of life data or some aspects of quality of life measures were significant independent predictors of survival duration .
Global quality of life , functioning domains and symptom scores - such as appetite loss , fatigue and pain - were the most important indicators , individually or in combination , for predicting survival times in cancer patients after adjusting for one or more demographic and known clinical prognostic factors .
Conclusion This review provides evidence for a positive relationship between quality of life data or some quality of life measures and the survival duration of cancer patients .
Pre-treatment ( baseline ) quality of life data appeared to provide the most reliable information for helping clinicians to establish prognostic criteria for treating their cancer patients .
This strategy is likely to yield more accurate and specific quality of life-related prognostic variables for specific cancers | Background Health-related quality of life and survival are two important outcome measures in cancer research and practice .
The aim of this paper is to examine the relationship between quality of life data and survival time in cancer patients . | PURPOSE To investigate the benefit of chemotherapy in patients with symptomatic hormone-resistant prostate cancer using relevant end points of palliation in a r and omized controlled trial . PATIENTS AND METHODS We r and omized 161 hormone-refractory patients with pain to receive mitoxantrone plus prednisone or prednisone alone ( 10 mg daily ) . Nonresponding patients on prednisone could receive mitoxantrone subsequently . The primary end point was a palliative response defined as a 2-point decrease in pain as assessed by a 6-point pain scale completed by patients ( or complete loss of pain if initially 1 + ) without an increase in analgesic medication and maintained for two consecutive evaluations at least 3 weeks apart . Secondary end points were a decrease of > or = 50 % in use of analgesic medication without an increase in pain , duration of response , and survival . Health-related quality of life was evaluated with a series of linear analog self- assessment scales ( LASA and the Prostate Cancer-Specific Quality -of-Life Instrument [ PROSQOLI ] ) , the core question naire of the European Organization for Research and Treatment of Cancer ( EORTC ) , and a disease-specific module . RESULTS Palliative response was observed in 23 of 80 patients ( 29 % ; 95 % confidence interval , 19 % to 40 % ) who received mitoxantrone plus prednisone , and in 10 of 81 patients ( 12 % ; 95 % confidence interval , 6 % to 22 % ) who received prednisone alone ( P = .01 ) . An additional seven patients in each group reduced analgesic medication > or = 50 % without an increase in pain . The duration of palliation was longer in patients who received chemotherapy ( median , 43 and 18 weeks ; P < .0001 , log-rank ) . Eleven of 50 patients r and omized to prednisone treatment responded after addition of mitoxantrone . There was no difference in overall survival . Treatment was well tolerated , except for five episodes of possible cardiac toxicity in 130 patients who received mitoxantrone . Most responding patients had an improvement in quality -of-life scales and a decrease in serum prostate-specific antigen ( PSA ) level . CONCLUSION Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer The Qualitator is a daily diary card to measure Quality of Life , developed for use in chemotherapy trials for patients with advanced breast cancer . In a trial at King 's College Hospital , 29 patients completed the Qualitator and their scores were compared with scores in the Linear Analogue Self- Assessment and Nottingham Health Profile taken four-weekly . In a separate study at Guy 's Hospital , 31 patients completed the diary . The Qualitator offers accurate prognostic data regarding subsequent UICC response and survival and is simple to use The objective of this study is to evaluate whether patient-reported baseline health-related quality of life ( HRQL ) measured by the Functional Assessment of Cancer Therapy-General ( FACT-G ) instrument is predictive of survival for patients with advanced lung cancer . Methods : Consecutive patients with advanced lung cancer planning to undergo palliative chemotherapy in the outpatient clinics of a Canadian tertiary care cancer centre were enrolled on study . FACT-G total scores and clinical predictors of survival ( age , sex , histology , stage of disease , previous weight loss , presence of liver metastases and performance status ) were prospect ively collected at baseline . Survival data was subsequently collected retrospectively from the Alberta Cancer Registry . Stratified Cox Proportional Hazards analysis was done examining the influence of baseline total FACT-G scores on survival , controlling for potential clinical confounders . Results : Median survival of the 42 patient cohort was 9.9 months with a 2-year survival of 16.7 % . Multivariate analysis indicated that baseline FACT-G total score is significantly associated with survival ( p= 0.004 ) . Conclusion : Baseline HRQL is a statistically significant predictor of survival for patients with advanced lung cancer . When used along with traditional clinical factors , patient-reported baseline HRQL assessment using the FACT-G provides additional prognostic information to the patient and clinician BACKGROUND The psychological response to breast cancer , such as a fighting spirit or an attitude of helplessness and hopelessness toward the disease , has been suggested as a prognostic factor with an influence on survival . We have investigated the effect of psychological response on disease outcome in a large cohort of women with early-stage breast cancer . METHODS 578 women with early-stage breast cancer were enrolled in a prospect i ve survival study . Psychological response was measured by the mental adjustment to cancer ( MAC ) scale , the Courtauld emotional control ( CEC ) scale , and the hospital anxiety and depression ( HAD ) scale 4 - 12 weeks and 12 months after diagnosis . The women were followed up for at least 5 years . Cox 's proportional-hazards regression was used to obtain the hazard ratios for the measures of psychological response , with adjustment for known clinical factors associated with survival . FINDINGS At 5 years , 395 women were alive and without relapse , 50 were alive with relapse , and 133 had died . There was a significantly increased risk of death from all causes by 5 years in women with a high score on the HAD scale category of depression ( hazard ratio 3.59 [ 95 % CI 1.39 - 9.24 ] ) . There was a significantly increased risk of relapse or death at 5 years in women with high scores on the helplessness and hopelessness category of the MAC scale compared with those with a low score in this category ( 1.55 [ 1.07 - 2.25 ] ) . There were no significant results found for the category of " fighting spirit " . INTERPRETATION For 5-year event-free survival a high helplessness/hopelessness score has a moderate but detrimental effect . A high score for depression is linked to a significantly reduced chance of survival ; however , this result is based on a small number of patients and should be interpreted with caution Measurement of health-related quality of life was integrated into a r and omized trial ( NMSG 4/90 ) comparing melphalan/prednisone to melphalan/prednisone + interferon alpha-2b in newly diagnosed multiple myeloma . One of the aims of the study was to assess the prognostic significance of quality -of-life scores , using the EORTC QLQ-C30 question naire . Univariate analysis showed a highly significant association with survival from the start of therapy for physical functioning as well as role and cognitive functioning , global quality of life , fatigue and pain . In multivariate analysis , physical functioning and W.H.O. performance status were independent prognostic factors ( P values = 0.001 for both ) when analysed in a Cox regression model with the somatic variables beta-2 microglobulin , skeletal disease and age . The best prediction for survival from the start of therapy was obtained by combining the beta-2 microglobulin and physical functioning scores in a variable consisting of three risk factor levels with an estimated median survival of 17 , 29 and 49 months , respectively . At a 12 months l and mark analysis , the relative risk for patients with physical functioning score 0 - 20 v 80 - 100 was 5.63 ( 99 % CI 2.76 - 11.49 ) , whereas the relative risk for patients without an objective response to chemotherapy compared to those with at least a minor response was 2.32 ( 99 % CI 1.44 - 3.74 ) . Quality -of-life assessment may be an independent and valuable addition to the known prognostic factors in multiple myeloma PURPOSE Evidence that psychosocial status and health-related quality of life ( HRQOL ) are associated with breast cancer ( BC ) outcomes is weak and inconsistent . We examined prognostic effects of these factors in a prospect i ve cohort study . PATIENTS AND METHODS Three hundred ninety-seven women with surgically resected T1 to T3 , N0/N1 , M0 BC completed the European Organization for Research and Treatment of Cancer Quality of Life Question naire ( Core 30 items ) , Profile of Mood States , Psychosocial Adjustment to Illness Scale , Impact of Events Scale , Mental Adjustment to Cancer Scale , and the Courtauld Emotional Control Scale 2 months after diagnosis and 1 year later . Data on tumor-related factors , treatment , and outcomes were obtained prospect ively from medical records , and Cox survival analyses were performed . RESULTS Mean age was 52.0 + /- 9.9 years . Two hundred twenty-five women had T1 , 136 women had T2 , 16 women had T3 , and 20 women had TX tumors ; 127 were N1 . One hundred thirteen women received adjuvant chemotherapy , 130 received hormone therapy , 45 received both , and 109 received neither . We investigated 140 prognostic associations ; four were found to be statistically significant at a P value of < /= .05 ( three fewer than expected by chance ) . Two were in the hypothesized direction of effect , and two were in the opposite direction . All arose from measurements 1 year after diagnosis , which were most susceptible to confounding by treatment . There was no evidence of consistency of associations across outcomes or question naires . These results are in keeping with chance as the explanation for our statistically significant findings . CONCLUSION HRQOL and psychosocial status at diagnosis and 1 year later are not associated with medical outcome in women with early-stage BC PURPOSE We observed that quality -of-life ( QL ) scores , collected to evaluate treatment in a r and omized trial in advanced breast cancer , predicted survival duration . This report explores the prognostic associations between QL and survival in more detail . PATIENTS AND METHODS In a r and omized clinical trial comparing intermittent and continuous therapy policies for patients with advanced breast cancer , QL was measured by linear analog self- assessment ( LASA ) and the Quality -of-Life Index ( QLI ) . Baseline scores and subsequent changes were included in statistical models of survival duration , with and without other prognostic factors . RESULTS Physician assessment of QLI and patient LASA scores for physical well-being ( PWB ) , mood , nausea and vomiting , appetite , and overall QL ( but not pain ) at the commencement of treatment were significant predictors of subsequent survival . Scores for PWB and QLI were independent of other prognostic factors . Changes in scores were also prognostically important . Both baseline and change in scores for PWB , mood , pain , and QLI after the first three treatment cycles , but before an arbitrary 180-day time point , were significantly predictive of survival beyond that time . Both QLI and PWB were prognostically independent of tumor response . Although QL improvement was correlated with tumor response , continuous therapy yielded significantly better QL scores , even in nonresponders . CONCLUSION These findings support the validity of the simple QL measures used in the trial . They are compatible with the simple explanation that patients perceive disease progression before it is clinical ly evident , but also with a causal relationship between QL and survival duration Background This paper describes the ethnic and socioeconomic correlates of functioning in a cohort of long-term nonrecurring breast cancer survivors . Methods Participants ( n = 804 ) in this study were women from the Health , Eating , Activity , and Lifestyle ( HEAL ) Study , a population -based , multicenter , multiethnic , prospect i ve study of women newly diagnosed with in situ or Stages I to IIIA breast cancer . Measurements occurred at three timepoints following diagnosis . Outcomes included st and ardized measures of functioning ( MOS SF-36 ) . Results Overall , these long-term survivors reported values on two physical function subscales of the SF-36 slightly lower than population norms . Black women reported statistically significantly lower physical functioning ( PF ) scores ( P = 0.01 ) , compared with White and Hispanic women , but higher mental health ( MH ) scores ( P < 0.01 ) compared with White and Hispanic women . In the final adjusted model , race was significantly related to PF , with Black participants and participants in the “ Other ” ethnic category reporting poorer functioning compared to the White referent group ( P < 0.01 , 0.05 ) . Not working outside the home , being retired or disabled and being unemployed ( on leave , looking for work ) were associated with poorer PF compared to currently working ( both P < 0.01 ) . Conclusion These data indicate that race/ethnicity influences psychosocial functioning in breast cancer survivors and can be used to identify need for targeted interventions to improve functioning Aim The aims of our study were to assess quality of life ( QoL ) as a prognostic factor of overall survival ( OS ) and to determine whether QoL data improved three prognostic classifications among French patients with advanced hepatocellular carcinoma ( HCC ) . Methods We pooled two r and omized clinical trials conducted by the Fédération Francophone de Cancérologie Digestive in a palliative setting . In each trial QoL was assessed at baseline using the Spitzer QoL Index ( 0–10 ) . Three prognostic classifications were calculated : Okuda , Cancer of the Liver Italian Program ( CLIP ) , and Barcelona Clinic Liver Cancer group ( BCLC ) scores . To explore whether the scores could be improved by including QoL , univariate Cox analyses of all potential baseline predictors were performed . A final multivariate Cox model was constructed including only significant multivariate baseline variables likely to result in improvement of each scoring system . In order to retain the best prognostic variable to add for each score , we compared Akaike information criterion , likelihood ratio , and Harrell ’s C-index . Cox analyses were stratified for each trial . Results Among 538 included patients , QoL at baseline was available for 489 patients ( 90 % ) . Longer median OS was significantly associated with higher Spitzer scores at baseline , ranging from 2.17 months ( Spitzer = 3 ) to 8.93 months ( Spitzer = 10 ) . Variables retained in the multivariate Cox model were : jaundice , hepatomegaly , hepatalgia , portal thrombosis , alphafetoprotein , bilirubin , albumin , small HCC , and Spitzer QoL Index ( hazard ratio = 0.84 95 % CI [ 0.79–0.90 ] ) . According to Harrell ’s C-index , QoL was the best prognostic variable to add . CLIP plus the Spitzer QoL Index had the most discriminating value ( C = 0.71 ) . Conclusions Our results suggest that QoL is an independent prognostic factor for survival in HCC patients with mainly alcoholic cirrhosis . The prognostic value of CLIP score could be improved by adding Spitzer QOL Index scores Background Cancer survival has been observed to be poorer in low socioeconomic groups , but the knowledge about the underlying causal factors is limited . The purpose of this study was to examine how cancer survival varies by socioeconomic status ( SES ) among women in Norway , and to identify factors that explain this variation . SES was measured by years of education and gross household income , respectively . Methods We used data from The Norwegian Women and Cancer Study , a prospect i ve cohort study including 91 814 women who responded to an extensive question naire between 1996 and 1998 . A total of 3 899 incident cancer cases were diagnosed during follow-up , of whom 1 089 women died , 919 of them from cancer . Cox Proportional Hazards Model was used to calculate relative risks ( RR ) of mortality and 95 % confidence intervals . Results We observed an overall negative socioeconomic gradient in cancer survival , which was most evident in the site specific analyses for survival of ovarian cancer by years of education . For colorectal cancer , mortality increased with years of education , but not with income . After adjustment for household size , marital status , disease stage , and smoking status the SES variation in cancer survival became non-significant . We found that the unequal socioeconomic distribution of smoking status prior to diagnosis contributed considerably to the poorer survival in low SES groups . Conclusion We found an overall negative socioeconomic gradient in cancer survival when SES is measured as years of education or gross household income . Smoking status prior to diagnosis was an important predictive factor for socioeconomic variation in survival PURPOSE This is one of a few studies that have explored the value of baseline symptoms and health-related quality of life ( HRQOL ) in predicting survival in patients with brain cancer . PATIENTS AND METHODS Baseline HRQOL scores ( from the European Organisation for Research and Treatment of Cancer [ EORTC ] Quality of Life Question naire C30 and the EORTC Brain Cancer Module ) were examined in 247 patients with anaplastic oligodendrogliomas to determine the relationship with overall survival by using Cox proportional hazards regression models . Refined techniques as the bootstrap resampling procedure and the computation of C indexes and R2 coefficients were used to explore the stability of the models as well as better assess the potential benefit of using HRQOL to predict survival in clinical practice and research . RESULTS Classical analysis controlled for major clinical prognostic factors selected emotional functioning ( P = .0016 ) , communication deficit ( P = .0261 ) , future uncertainty ( P = .0481 ) , and weakness of legs ( P = .0001 ) as statistically significant prognostic factors of survival . However , several issues question the validity of these findings and no single model was found to be preferable over all others . C indexes , which estimate the probability of a model to correctly predict which patient among a r and omly chosen pair of patients will survive longer , and R2 coefficients , which measure the proportion of variability explained by the model , did not exhibit major improvement when adding selected or all HRQOL scores to clinical factors . CONCLUSION While classical techniques lead to positive results , more refined analyses suggest that baseline HRQOL scores add relatively little to clinical factors to predict survival . These results may have implication s for future use of HRQOL as a prognostic factor for patients with cancer OBJECTIVE To identify potential prognostic factors affecting the survival in patients with advanced cancer in a local palliative care unit . DESIGN Prospect i ve cohort study . SETTING Palliative Care Unit of a regional hospital in Hong Kong . PATIENTS All advanced cancer in- patients and out- patients who were enrolled into the palliative care service of the United Christian Hospital between January and December 2002 were recruited . MAIN OUTCOME MEASURES Potential prognostic factors including demographic data , tumour characteristics , blood parameters , functional status , co-morbidities , total symptom score , and psychosocial parameters were recorded upon enrollment . RESULTS A total of 170 patients were eligible for analysis ; their mean age was 69 ( st and ard deviation , 12 ) years , of which 106 ( 62 % ) were male . Overall median survival was 77 ( interquartile range , 31 - 160 ) days . The most frequent primary malignancy was lung ( n=58 , 34 % ) , followed by liver ( n= 24 , 14 % ) and lower gastro-intestinal tract ( n=24 , 14 % ) . By univariate analysis , 11 factors affected survival , including : age ( P=0.040 ) , number of metastatic sites involved ( P=0.001 ) , peritoneal metastases ( P=0.009 ) , skin metastases ( P=0.011 ) , tachycardia ( P=0.009 ) , serum albumin concentration ( P<0.001 ) , white cell count ( P=0.002 ) , Karnofsky Performance Status score ( P<0.001 ) , Hamilton Depression Scale score ( P=0.004 ) , Edmonton Symptom Assessment System score ( P=0.003 ) , and McGill Quality of Life ( Hong Kong)-single item score ( P=0.002 ) . Multivariable Cox regression analysis revealed that only age ( hazard ratio=0.84 ; 95 % confidence interval , 0.73 - 0.96 ) , number of metastatic sites involved ( 1.33 ; 1.13 - 1.56 ) , serum albumin concentration ( 0.95 ; 0.92 - 0.98 ) , Karnofsky Performance Status score ( 0.86 ; 0.78 - 0.96 ) , and Edmonton Symptom Assessment System score ( 1.22 ; 1.05 - 1.41 ) were independent prognosticators . CONCLUSION Age , number of involved metastatic sites , serum albumin , Karnofsky Performance Scale score , and Edmonton Symptom Assessment System score were independent prognosticators . Further studies are needed to provide a prognostic instrument applicable in local clinical setting BACKGROUND Both quality of life ( QoL ) and comorbidity influence therapy and prognosis of non-small-cell lung cancer ( NSCLC ) . We previously developed a lung cancer disease-specific simplified comorbidity score ( SCS ) and demonstrated the prognostic impact of this disease-specific instrument . This study aim ed at validating the SCS in a prospect i ve bicentric NSCLC population by measuring its relative prognostic determinant impact taking into account well-established variables such as QoL , performance status ( PS ) , Charlson comorbidity index ( CCI ) and disease stage . PATIENTS AND METHODS Prognostic values of different pretherapeutic features were tested in univariate and multivariate analyses in a population of 301 NSCLC . RESULTS Median survival was 17 months . One-third of patients reporting difficulties in their normal daily activities and an overall poor QoL. The following pretreament variables were independent determinants of a shorter overall survival : advanced disease , SCS , Lung Cancer Symptoms Scale global symptoms score , anaemia , hyponatremia , serum alkaline phosphatases level , serum CYFRA 21 - 1 and serum neuron-specific enolase . CONCLUSION In this extended validation population , the SCS is more informative than the CCI in predicting NSCLC patient outcome as the former is also more disease specific . Combination of both SCS comorbidity score and LSCC QoL yields a more accurate information that conventional analysis of PS PURPOSE To prospect ively assess the impact of treatment with cisplatin alone or in combination with topotecan ( CT ) on quality of life ( QOL ) in patients with advanced or recurrent cervical cancer , and to explore the prognostic value of baseline QOL scores . PATIENTS AND METHODS Patients entered on Gynecologic Oncology Group ( GOG ) Protocol 179 were expected to complete QOL assessment s at four time points using Functional Assessment of Cancer Therapy-General ( FACT-G ) , Cervix subscale ( Cx subscale ) , FACT/GOG-Neurotoxicity subscale ( NTX subscale ) , Brief Pain Inventory ( BPI ) , and UNISCALE ( UNI ) . Adjusting for patient age , baseline scores , and effects of time , we longitudinally examined treatment effect on QOL during and after chemotherapy . RESULTS Among patients r and omly allocated to receive cisplatin ( n = 146 ) or CT ( n = 147 ) , there were no statistically significant differences in QOL up to 9 months after r and omization despite more hematologic toxicity in the combination arm . QOL assessment s were completed at rates of 98 % , 85 % , 68 % , and 59 % , respectively , for the four time points , with similar rates and reasons for nonparticipation between regimens . Baseline FACT-G ( P = .0016 ) and BPI ( P = .0001 ) scores were significantly associated with patient age ; older patients had better QOL and less pain . Baseline UNI was positively correlated with FACT-G ( r = 0.66 ; P < .001 ) and Cx subscale ( r = 0.29 ; P < .001 ) , and negatively related to BPI ( r = -0.41 ; P < .0001 ) . Baseline FACT-Cx ( FACT-G + Cx subscale ) was associated with survival . CONCLUSION Despite increased toxicity , CT did not significantly reduce patient QOL when compared with cisplatin alone . Patient-reported QOL measures may be an important prognostic tool in advanced cervix cancer Background As part of a prospect i ve study on quality of life in newly diagnosed lung cancer patients an investigation was carried out to examine whether there were differences among patients ' quality of life scores and their socioeconomic status . Methods Quality of life was measured at two points in time ( baseline and three months after initial treatment ) using three st and ard instruments ; the Nottingham Health Profile ( NHP ) , the European Organization for Research and Cancer Treatment Quality of Life Question naire ( EORTC QLQ-C30 ) and its lung cancer supplement ( QLQ-LC13 ) . Socioeconomic status for each individual patient was derived using Carstairs and Morris Deprivation Category ranging from 1 ( least deprived ) to 7 ( most deprived ) on the basis of the postcode sector of their address . Results In all , 129 lung cancer patients entered into the study . Of these data for 82 patients were complete ( at baseline and follow-up ) . 57 % of patients were of lower socioeconomic status and they had more health problems , less functioning , and more symptoms as compared to affluent patients . Of these , physical mobility ( P = 0.05 ) , energy ( P = 0.01 ) , role functioning ( P = 0.04 ) , physical functioning ( P = 0.03 ) , and breathlessness ( P = 0.02 ) were significant at baseline . However , at follow-up assessment there was no significant difference between patient groups nor did any consistent pattern emerge . Conclusion At baseline assessment patients of lower socioeconomic status showed lower health related quality of life . Since there was no clear trend at follow-up assessment this suggests that patients from different socioeconomic status responded to treatment similarly . In general , the findings suggest that quality of life is not only the outcome of the disease and its treatment , but is also highly dependent on each patients ' socioeconomic characteristics This is one of the few studies that have explored the value of baseline symptoms and health-related quality of life ( HRQOL ) in predicting survival in brain cancer patients . Baseline HRQOL scores ( from the EORTC QLQ-C30 and the Brain Cancer Module ( BN 20 ) ) were examined in 490 newly diagnosed glioblastoma cancer patients for the relationship with overall survival by using Cox proportional hazards regression models . Refined techniques as the bootstrap re-sampling procedure and the computation of C-indexes and R2-coefficients were used to try and vali date the model . Classical analysis controlled for major clinical prognostic factors selected cognitive functioning ( P=0.0001 ) , global health status ( P=0.0055 ) and social functioning ( P<0.0001 ) as statistically significant prognostic factors of survival . However , several issues question the validity of these findings . C-indexes and R2-coefficients , which are measures of the predictive ability of the models , did not exhibit major improvements when adding selected or all HRQOL scores to clinical factors . While classical techniques lead to positive results , more refined analyses suggest that baseline HRQOL scores add relatively little to clinical factors to predict survival . These results may have implication s for future use of HRQOL as a prognostic factor in cancer patients BACKGROUND Patients with unresectable hepatocellular carcinoma ( HCC ) have a dismal prognosis . The objective of this study was to evaluate whether patient-reported baseline quality of life ( QoL ) measured by the EORTC QLQ-C30 instrument is predictive of survival for these patients . MATERIAL S AND METHODS Two hundred and thirty-three patients with unresectable HCC ( mainly hepatitis B-associated ) who were recruited into two separate r and omized phase III clinical studies , based on palliative chemotherapy and palliative hormonal therapy , respectively , gave consent and received pretreatment QoL assessment . EORTC QLQ-C30 scores and clinical variables at the time of study entry were analyzed to identify factors that influenced survival by applying multivariate analysis . Independent prognostic factors for survival were studied by Cox regression analysis . RESULTS Median survival of the 233 patients was 5.5 months ( 95 % CI 4.2 - 6.5 months ) . Significant independent predictors of shorter survival were advanced Okuda staging ( P = 0.0030 ; HR = 2.058 ) , high baseline total bilirubin ( P = 0.0008 ; HR = 1.013 ) and worse QoL score in the appetite score domain ( P = 0.0028 ; HR for 10 point increase = 1.070 ) . Patients who were entered into the chemotherapy trial ( P = 0.0002 ; HR = 0.503 ) , those who scored better in the physical functioning domain ( P = 0.0034 ; HR for 10 point decrease = 0.911 ) and the role functioning domain ( P = 0.0383 ; HR for 10 point decrease = 0.944 ) of the QoL question naire , were associated with longer survival . CONCLUSIONS In the studied HCC population , patient-reported baseline QoL provides additional prognostic information that supplements traditional clinical factors , and is a new prognostic marker for survival for patients with unresectable HCC This study was conducted to explore treatment and disease-related effects on health-related quality of life ( HRQoL ) in patients with aggressive lymphoma , to identify predictors for impaired long-term HRQoL , and to analyze the prognostic value of pretreatment HRQoL. Ninety-five patients with aggressive lymphoma , constituting a subset of a r and omized multicenter trial comparing CHOP and MACOP-B , entered a HRQoL study , using the EORTC QLQ-C30 question naire . Patient scores were compared to scores from an age- and genderadjusted reference population sample , and evaluation of the prognostic value of pretreatment QoL scores in relation to clinical prognostic factors was performed . Before treatment , patients exhibited lower scores of global QoL , physical , role , and social functions , and more appetite loss , compared to the reference population . Role functioning improved compared to baseline , but remained depressed compared to the reference group more than 8 mo after end of treatment . By then , the patient group displayed no difference in other HRQoL variables compared to that of the reference population . No reliable predictor for impaired long-term HRQoL could be identified . In multivariate analysis , including the factors of the International Prognostic Index , pretreatment global QoL was an independent prognostic marker for overall survival . In conclusion , in this population with aggressive lymphoma and favorable prognostic features , HRQoL was not substantially affected during the first year after diagnosis . Pretreatment global QoL may constitute a significant prognostic factor , meriting further investigation in prospect i ve studies Quality of life ( QL ) scores may be used to assess the impact of disease and treatment , and to predict survival of cancer patients in prospect i ve clinical trials . The aim of this study was to evaluate the prognostic association of QL scores among patients with advanced malignancies in routine practice . Adult patients with advanced malignancy from 12 institutions in 10 countries completed the EORTC QLQ-C30 question naire , in their native language , once at study entry . Baseline patient and disease characteristics were recorded . We used a proportional hazards model stratified on diagnostic category to test whether QL scores from the QLQ-C30 were significantly and independently predictive of overall survival duration from the time of QL measurement . In all , 735 eligible patients were entered between November 1989 and September 1995 . On 1 October 1995 , follow-up information was obtained on 656 patients , of whom 411 had died . Patient and disease factors predictive of worse survival were age and performance status . The global scale and the scales of physical , role , emotional , cognitive and social function were each significantly predictive of subsequent survival duration in univariate analyses . Single-item QL scores for overall physical condition ( question 29 ) , overall quality of life ( question 30 ) , and the global and social functioning scales remained independently prognostic after allowing for performance status and age , and , among solid tumour patients , metastatic site . QL can be measured in an international setting based on routine oncology practice . QL scores carry prognostic information independent of other recorded factors The aim of this study was to investigate the influence of baseline quality of life ( QoL ) on survival in patients with advanced colorectal cancer . From 1992 to 1998 , four r and omised clinical trials in advanced colorectal cancer were conducted at this institution . The European Organization for Research and Treatment of Cancer- Quality of Life Core 30 ( EORTC-QLQ-C30 ) question naire was completed prior to the commencement of chemotherapy . Analyses were performed on median-dichotomised baseline Quality of Life ( QoL ) and clinical prognostic factors . Baseline QoL question naires were completed by 501 patients . One-year survival was 38.3 and 72.5 % ( P<0.0001 ) for patients with global QoL scores below and above the median ( 67 ) , respectively . Other than cognitive functioning , fatigue , appetite , constipation , diarrhoea and financial domains , all QoL scales were significant independent predictors of survival ( P<0.035 ) . In the final model , the global QoL score remained highly significant as an independent predictor of survival ( P<0.0001 ) . Baseline QoL is a strong independent predictor of survival in patients with advanced colorectal cancer . Measurements should be routinely recorded in clinical trials to stratify cohorts and aid in trial comparison OBJECTIVE : To describe the quality of life ( QOL ) over time for adults with newly diagnosed high- grade gliomas and to examine the relationship between QOL and outcome data collected in three prospect i ve cooperative group clinical trials . METHODS : The QOL study was a companion protocol for three Phase II high- grade glioma protocol s. Five self-administered forms were completed by patients to assess QOL at study entry , 2 months , and 4 months after enrollment . RESULTS : QOL data were available for baseline , first , and second subsequent follow-up evaluations for 89 % , 71 % , and 69 % of patients , respectively . A significant proportion of patients ( 47.1 % ) experienced impaired QOL ( QOL ≤ 50 ) in at least one measure at subsequent evaluations , whereas most patients ( 88 % ) with impaired QOL at baseline continued to have impaired QOL at subsequent evaluations . On multivariable analyses , baseline QOL measures were predictive of QOL at the time of follow-up . In addition , patients who underwent a gross total resection were much less likely to have impaired QOL ( P = 0.006 ) , were less likely to experience worsening depression ( P = 0.0008 ) , and were more likely to have improved QOL ( P = 0.003 ) at their first follow-up evaluation . Changes in QOL measures over time were not found to be associated with survival in multivariable analyses that adjusted for known prognostic variables ; variables that were independently associated with improved survival were better performance status ( P < 0.001 ) , younger age ( P < 0.001 ) , and greater extent of resection ( P < 0.001 ) . CONCLUSION : Baseline QOL was predictive of QOL over time . Gross total resection was associated with longer survival and improved QOL over time for patients with high- grade gliomas Summary Objective To assess baseline quality of life ( QOL ) and its prognostic importance for adults with newly diagnosed high- grade gliomas , we analyzed QOL and outcome data prospect ively collected in three phase II high- grade glioma protocol s. Methods At study entry , patients completed five self-administered forms to assess overall QOL ( linear analogue scale assessment [ LASA ] and Functional Assessment of Cancer Therapy-Brain [ FACT-Br ] ) ; fatigue ( Symptom Distress Scale [ SDS ] ) ; excessive daytime somnolence ( Epworth Sleepiness Scale [ ESS ] ) ; and depression ( POMS-SF ) . Folstein Mini-Mental State Examination ( MMSE ) and Eastern Cooperative Oncology Group ( ECOG ) performance scores ( PS ) were obtained by the health care provider . Results Baseline QOL data were available for 194 of 220 patients ( 88 % ) enrolled in the three protocol s. Differences in baseline QOL among the three studies were not statistically significant . One-third of patients had clinical ly significant fatigue at baseline . Increased fatigue ( P = 0.003 ) , excessive daytime somnolence ( P = 0.01 ) , and lower overall QOL scores ( LASA , P = 0.001 ; FACT-Br , P = 0.0001 ) correlated with worse ECOG PS . No relation was found between QOL and corticosteroid or anticonvulsant therapy , extent of resection , tumor grade , or sex . Multivariate analyses found worse ECOG PS ( PS 2 , P = 0.007 ) associated with increased fatigue . Worse ECOG PS ( PS 2 , P = 0.002 ) was also associated with worse overall QOL ( LASA ) . On multivariate analyses of survival , increased fatigue ( P = 0.003 ) predicted poorer overall survival . Conclusions Performance status is related to QOL in patients with newly diagnosed high- grade brain tumors . Increased fatigue is an independent predictor of overall survival . Interventional studies directed at improving QOL , especially fatigue , may have important benefits for these patients Purpose : The main purpose of this paper is to present the results of a r and omized trial comparing the effects of two chemotherapy regimens on the Quality of life ( QOL ) of patients with advanced non-small-cell lung cancer ( NSCLC ) . Trials in advanced stage disease represent an important treatment context for QOL assessment . A second purpose of this paper is to examine methods for h and ling the level of missing data commonly observed in the advanced stage disease context . Methods : Patients were r and omized to receive cisplatin plus vinorelbine or carboplatin plus paclitaxel . The QOL of 222 patients was assessed with the Functional Assessment of Cancer Therapy – Lung ( FACT-L ) prior to r and omization ; follow-up assessment s occurred at 13 and 25 weeks . Three methods were used to analyze the QOL data : ( 1 ) cross-sectional analysis of four patient categories ( improved , stable , missing , and declined ) based on changes in the FACT-L score , ( 2 ) a mixed linear model , and ( 3 ) a pattern mixture model . The longitudinal analyses addressed two potential data biases . Results : Question naire su bmi ssion rates were 91 % at baseline , 68 % at 13 weeks , and 47 % at 25 weeks . The cross-sectional and mixed linear model analyses did not show significant differences by treatment arm in patient-reported QOL . The pattern mixture model analysis , more appropriate given non-ignorable missing data , also found no statistically significant effect of treatment on patient QOL . Conclusion : We present a sensitivity analysis approach with multiple methods for analyzing treatment effects on patient QOL in the presence of substantial , non-ignorable missing data in an advanced stage disease clinical trial . We conclude that the two treatment arms did not differ statistically in their effects on patient QOL over a 25-week treatment period Since chemotherapy for metastatic breast cancer is not curative , consideration of the quality of life is important in selecting a treatment regimen . We conducted a r and omized trial comparing continuous chemotherapy , administered until disease progression was evident , with intermittent therapy , whereby treatment was stopped after three cycles and then repeated for three more cycles only when there was evidence of disease progression . Each approach was tested with doxorubicin combined with cyclophosphamide or with cyclophosphamide combined with methotrexate , fluorouracil , and prednisone . Intermittent therapy result ed in a significantly worse response ( P = 0.02 by Mann-Whitney test ) , a significantly shorter time to disease progression ( relative risk based on proportional-hazards model , 1.8 ; 95 percent confidence interval , 1.4 to 2.4 ) , and a trend toward shorter survival ( relative risk , 1.3 ; confidence interval , 0.99 to 1.6 ) . The quality of life was expressed as linear-analogue self- assessment scores for physical well-being , mood , pain , and appetite and as a quality -of-life index . It improved significantly during the first three cycles , when all patients received treatment . Thereafter , intermittent therapy was associated with worse scores for physical well-being ( by 23 percent of scale ; 95 percent confidence interval , 11 to 35 percent ) , mood ( 25 percent ; 13 to 37 percent ) , and appetite ( 12 percent ; 0 to 24 percent ) and for the quality -of-life index as indicated by the patient ( 14 percent ; 5 to 23 percent ) and the physician ( 16 percent ; 7 to 26 percent ) . Changes in the quality of life were independent prognostic factors in proportional-hazards models of subsequent survival . We conclude that , as tested , continuous chemotherapy is better than intermittent chemotherapy for advanced breast cancer Purpose To determine whether patients ’ self-reported quality -of-life ( QOL ) parameters could predict survival for patients with advanced gastric cancer ( AGC ) treated with first-line chemotherapy , we performed this analysis based on the data obtained from 254 patients enrolled in three consecutive prospect i ve r and omized trials at a single institution . Methods Consenting patients with AGC received first-line chemotherapy as specified in the protocol s. QOL was assessed at baseline using the European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-C30 question naires . Baseline univariate and multivariate analyses were performed on the QOL data and the recognized clinical predictors for survival . Results Of 254 patients , 164 completed the QOL question naire at baseline . All patients received fluorouracil-containing first-line chemotherapy for AGC . With 88 % observed deaths and a reported median survival of 9.5 months [ 95 % confidence interval ( CI ) 8.8–10.2 months ] , there were no significant differences in survival between patients with or without QOL data . The final Cox multivariate model revealed four prognostic factors : age [ hazard ratio ( HR ) 2.08 , 95 % CI 1.32–3.33 , P = 0.002 ] , bone metastasis ( HR 2.70 , 95 % CI 1.30–5.56 , P = 0.008 ) , hemoglobin ( HR 0.58 , 95 % CI 0.37–0.92 , P = 0.020 ) , and social functioning ( HR 0.40 , 95 % CI 0.23–0.64 , P = 0.001 ) . When adjusting for clinical parameters , social functioning was an independently significant prognostic factor for longer survival . Conclusion Baseline social functioning , along with age , presence of bone metastasis , and baseline hemoglobin level , independently predicts survival of AGC patients treated with first-line chemotherapy . QOL assessment should be routinely included to provide useful prognostic information concerning AGC patients PURPOSE To analyze the prospect ively collected health-related quality -of-life ( HRQOL ) data from patients enrolled in two Radiation Therapy Oncology Group r and omized Phase III head and neck cancer trials ( 90 - 03 and 91 - 11 ) to assess their value as an independent prognostic factor for locoregional control ( LRC ) and /or overall survival ( OS ) . METHODS AND MATERIAL S HRQOL question naires , using a vali date d instrument , the Functional Assessment of Cancer Therapy-Head and Neck ( FACT-H&N ) , version 2 , were completed by patients before the start of treatment . OS and LRC were the outcome measures analyzed using a multivariate Cox proportional hazard model . RESULTS Baseline FACT-H&N data were available for 1,093 patients and missing for 417 patients . No significant difference in outcome was found between the patients with and without baseline FACT-H&N data ( p = 0.58 ) . The median follow-up time was 27.2 months for all patients and 49 months for surviving patients . Multivariate analyses were performed for both OS and LRC . Beyond tumor and nodal stage , Karnofsky performance status , primary site , cigarette use , use of concurrent chemotherapy , and altered fractionation schedules , the FACT-H&N score was independently predictive of LRC ( but not OS ) , with p = 0.0038 . The functional well-being component of the FACT-H&N predicted most significantly for LRC ( p = 0.0004 ) . CONCLUSIONS This study represents , to our knowledge , the largest analysis of HRQOL as a prognostic factor in locally advanced head and neck cancer patients . The results of this study have demonstrated the importance of baseline HRQOL as a significant and independent predictor of LRC in patients with locally advanced head and neck cancer OBJECTIVE To assess whether pretreatment and posttreatment quality of life ( QOL ) is associated with long-term survival in patients with head and neck cancer . DESIGN Ten-year follow-up of an inception cohort . SETTING Regional tertiary referral center . PATIENTS The study included 200 consecutive patients with primary epithelial head and neck cancer . INTERVENTIONS Quality of life and several recognized risk factors for death were assessed prospect ively using the Auckl and QOL question naire before treatment and 12 months after treatment ; survival was determined at 10 years . MAIN OUTCOME MEASURES Survival and odds of death ( hazards ratio ) were measured . RESULTS At 10 years , 136 patients ( 68 % ) were deceased , 48 patients ( 24 % ) were alive , and the status of 16 patients ( 8 % ) was unknown . Median survival was 6 years ( interquartile range , 4.4 - 7.7 ) . Before treatment , patients with low QOL had no significantly increased odds of death ( hazard ratio , 1.4 ; 95 % confidence interval , 0.8 - 2.4 ) . In contrast , after treatment , patients with low QOL at 1 year had significantly increased odds of death ( 2.5 ; 95 % confidence interval , 1.4 - 4.3 ; P = .001 ) even after adjustment for covariates . CONCLUSIONS Findings suggest potential survival benefits from improvements in QOL . However , the observed associations between survival benefit and QOL at 1 year may be confounded by comorbidity , which was not measured and deserves further investigation The objective of the current study was to examine whether emotional well‐being predicted survival in a large sample of patients with head and neck cancer who were participating in multicenter clinical trials PURPOSE To determine the prognostic value of pleural fluid pH , pleural fluid glucose , extent of pleural carcinomatosis ( EPC ) score , and Karnofsky Performance Scale ( KPS ) score in patients with recurrent symptomatic malignant pleural effusions . DESIGN Prospect i ve 53-month study . SETTING Referral center for interventional pulmonology . PATIENTS Eighty-five consecutive patients ( 42 men and 43 women ) with recurrent symptomatic malignant pleural effusions who were referred to the interventional pulmonary service for thoracoscopic pleurodesis . MEASUREMENTS Pleural fluid pH , pleural fluid glucose , EPC score , and KPS score . RESULTS The KPS score was the only statistically significant predictor variable . Patients with a KPS score > /= 70 had a median survival of 395 days , as opposed to a median survival of only 34 days for patients with a KPS score < /= 30 . No prognostic advantage was evident when patients were categorized by pleural fluid pH , pleural fluid glucose , or EPC score . CONCLUSION When assessing the prognosis of a patient with a recurrent symptomatic malignant pleural effusion , only the KPS score at the time of thoracoscopy is predictive of survival . Pleural fluid pH , pleural fluid glucose , and EPC scores are not as reliable as initially reported . For patients with a KPS score > /= 70 , it may be very reasonable to proceed with thoracoscopic talc pleurodesis for management of their malignant pleural effusions In a prospect i ve controlled clinical trial , 102 patients with inoperable non-small cell lung cancer ( NSCLC ) , limited disease , stage II and III were treated with combination chemotherapy , cisplatin 70 mg/m2 i.v . on day one and etoposide 100 mg/m2 i.v . on day one , and etoposide 200 mg/m2 orally on days 2 and 3 , or radiotherapy given in 15 fractions of 2.8 Gy with two anterior/posterior fields during a period of three weeks . The patients completed a vali date d self-administered question naire before the start of treatment that assessed their psychosocial well-being , disease-related symptoms , personal functioning , and everyday activity . These subjective variables were evaluated together with treatment modality , WHO performance status , weight loss , and stage of disease , with regard to their value in predicting survival . Univariate survival analyses were undertaken for each individual factor , median survival was calculated according to life-table analyses . A step-wise multiple regression analysis was used to measure the prognostic value of the various factors . In the univariate analysis , general symptoms ( p = 0.0006 ) psycho-social well-being ( p = 0.0002 ) and stage of disease ( p = 0.007 ) were the best predictive factors . In the multiple regression analyses the subjective variables , general symptoms ( p less than 0.01 ) and psychosocial well-being ( p less than 0.05 ) were shown to have the best predictive value for the patients ' survival Prospect i ve studies of the general population have isolated specific social and psychological factors as independent predictors of longevity . This study assesses the ability of these factors , plus two others said to influence survival in patients with cancer , to predict survival and the time to relapse after a diagnosis of cancer . Patients with unresectable cancers ( n = 204 ) were followed to determine the length of survival . Patients with Stage I or II melanoma or Stage II breast cancer ( n = 155 ) were followed to determine the time to relapse . Analysis of data on these 359 patients indicates that social and psychological factors individually or in combination do not influence the length of survival or the time to relapse ( P less than 0.10 ) . The specific diagnosis ( F = 2.0 , P = 0.06 ) , performance status ( F = 0.66 , P = 0.62 ) , extent of disease ( F = 1.12 , P = 0.89 ) , and therapy ( F = 1.08 , P = 0.35 ) were also unrelated to the psychosocial factors studied . Although these factors may contribute to the initiation of morbidity , the biology of the disease appears to predominate and to override the potential influence of life-style and psychosocial variables once the disease process is established A prospect i ve study was conducted to measure quality of life in newly diagnosed lung cancer patients attending a chest clinic in a large teaching and district general hospital in a geographically defined area ( northern sector of Glasgow , Scotl and ) . Quality of life was assessed at two points in time , pre-diagnosis ( baseline ) and 3 months after diagnosis ( follow-up ) using three st and ard measures ; the Nottingham Health Profile ( NHP ) ; the European Organisation for Research and Treatment of Cancer Quality of Life Question naire ( EORTC QLQ-C30 ) , and its lung cancer supplement ( QLQ-LC13 ) . Out of 133 lung cancer patients diagnosed during the study period , 129 patients ( 97 % ) were interviewed pre-diagnosis . Of these , only 63 % of the patients had an active treatment . Ninety-six patients were alive at follow-up , of whom 82 patients were re-interviewed . Thus , only 82 patients who had complete data were used in the analysis . Comparing patients ' pre-diagnosis and follow-up scores on the NHP , only sleep difficulties improved slightly . Patients reported increased perceived health problems of all other characteristics studied ( energy , p = 0.0004 ; physical mobility , p = 0.0008 ) . Similar results were observed on the EORTC question naires indicating that patients ' functioning and global quality of life had decreased . The only significant improvement after 3 months was seen in patients ' cough ( p = 0.006 ) . There were marked increases in hair loss ( p > 0.0001 ) , constipation ( p = 0.007 ) , and sore mouth ( p = 0.0004 ) . The findings suggest that patient-centred variables should receive sufficient consideration in the treatment of lung cancer . The study results clearly indicate that information on quality of life contributes to our underst and ing of patients ' experiences of their cancer treatment PURPOSE To determine the contribution of cognitive function in predicting the survival of patients with recurrent malignant brain tumors . PATIENTS AND METHODS A total of 80 patients with recurrent glioblastoma multiforme or anaplastic astrocytoma were seen for baseline evaluations before beginning a phase I or phase II clinical trial . Each patient received a battery of nine brief tests measuring cognitive function , ability to perform activities of daily living ( ADLs ) , and quality of life ( QOL ) . Tests were given monthly after treatment was begun . RESULTS Performance on a test of verbal memory was independently and strongly related to survival after accounting for age , Karnofsky performance status score , histology , and time since diagnosis . Models incorporating three of nine and all nine tests in the battery accounted for significantly more variance in survival than did the clinical variables alone . Measures of QOL and ADLs ( bathing , feeding , and so on ) were not independently related to survival , although they provide clinical information that is important for patient care . CONCLUSION These results indicate that a multifaceted assessment of cognition , QOL , and patient function is practical for brain tumor patients in clinical trials and can provide information regarding the relative risks versus benefits of new treatment regimens that supplements the information from the usual clinical variables PURPOSE To determine the ability of longitudinal patient-reported health ( PRH ) scores to enhance prediction of clinical outcomes beyond baseline scores . PATIENTS AND METHODS In 573 advanced non-small-cell lung cancer patients enrolled in a phase III clinical trial , we used baseline and 6-week follow-up PRH scores to predict best response to treatment , disease progression , and survival . Using regression analyses , we tested the predictive ability of the five subscales of the Functional Assessment of Cancer Therapy-Lung ( physical , functional , social/family , emotional well-being , and the lung cancer subscale ) as well as the trial outcome index ( TOI ) aggregate score . RESULTS After clinical factors were controlled for , baseline physical well-being ( PWB ) and TOI scores predicted all three clinical outcomes . A higher baseline PWB score was associated with a better response to treatment ( odds ratio , 1.09 ; P < .001 ) and lower risk of death ( risk ratio , 0.95 ; P < .001 ) . Higher baseline TOI score was associated with a lower risk of disease progression ( risk ratio , 0.98 ; P < .001 ) . These two baseline predictors ( PWB and TOI ) were then used along with 6-week change scores to classify patients into four groups : low baseline-declined , low baseline-improved , high baseline-declined , and high baseline-improved . Patients with low baseline-declined PWB scores showed the worst responses to treatment and survived the shortest duration . Patients with low baseline-declined TOI scores had the shortest time to progression . CONCLUSION The physical aspects of baseline PRH and PRH change during chemotherapy are significant predictors of clinical outcomes in lung cancer . This has implication s for patient stratification in clinical trials and may aid decision-making in clinical practice Several studies have recently reported on the importance of quality of life ( QOL ) in predicting the survival of patients with lung carcinoma . To confirm these reports , the relationship between survival and QOL , as measured by the European Organization for Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire and Duke‐UNC Social Support Scale , was examined within a group of 206 patients with advanced nonsmall cell lung carcinoma treated in a r and omized clinical trial conducted by the Cancer and Leukemia Group B ( CALGB 8931 ) PURPOSE Bortezomib , a boronic acid dipeptide , has been recently introduced as a new approach to treating multiple myeloma ( MM ) . The goal of this work was to evaluate the added value of patient-reported outcomes ( PRO ) in the interpretation of bortezomib clinical trial outcomes . PATIENTS AND METHODS Two hundred two patients with relapsed , refractory MM were treated with bortezomib as part of the SUMMIT ( Study of Uncontrolled Multiple Myeloma Managed with Proteasome Inhibition Therapy ) study . Patients were administered the following four PRO measures at several time points : the European Organisation for Research and Treatment of Cancer ( EORTC ) core Quality of Life Question naire ( QLQ-C30 ) and the myeloma-specific module ( QLQ-MY24 ) , the Functional Assessment of Chronic Illness Therapy ( FACIT ) Fatigue scale , and the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group ( GOG ) Neurotoxicity ( Ntx ) scale . Minimal important difference ( MID ) thresholds were used to define patients as improved , stable , or worsened . A survival analysis was conducted to assess the predictive power of PRO data . RESULTS For the total population , there was a positive change between baseline and best end point . Consistent with the clinical responses , change in PRO scores showed statistically significant differences between response groups with PRO improvement in patients with complete response ( CR ) or partial response ( PR ) , mostly stable scores in patients with minor response or no change , and deterioration in most scores for patients with progressive disease . Change in scores for neuropathy-related symptoms was reasonably stable . In contrast , fatigue scores significantly improved for patients with CR or PR . When various MID thresholds were applied , the proportion of improved patients exceeded 35 % for several domains within all change group definitions . Moreover , survival analysis results demonstrated the additional prognostic information PRO data can provide to supplement clinical data . CONCLUSION This study demonstrated the complementary value for PRO assessment s in further interpreting clinical response , the impact of adverse effects , and patient prognosis in clinical trials PURPOSE Malignant pleural mesothelioma ( MPM ) is a rare disease . Unlike other advanced cancer types , little is known about patient-reported symptoms or health-related quality of life ( HRQOL ) and their possible prognostic value . This study reports an evaluation of the prognostic value of these factors using data gathered from a recent r and omized controlled trial . PATIENTS AND METHODS Patients were entered onto this trial if they had a histologically proven unresectable MPM , not pretreated with chemotherapy , WHO performance status < or = 2 , and adequate hematologic , renal , and hepatic function . Patients were r and omly assigned to receive cisplatin 80 mg/m2 intravenously on day 1 , without or with preceding infusion of raltitrexed 3 mg/m2 . HRQOL was assessed using the European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-C30/Lung Cancer 13 tool . The Cox proportional hazards regression model was used for the univariate and multivariate analyses of survival , along with a bootstrap validation technique . Included were the EORTC prognostic index ( PI ) composed of stage of disease , histology type , time since diagnosis , and WBC , and , in addition , 10 selected key symptoms and HRQOL scales . RESULTS Two hundred fifty patients were r and omly assigned ( 80 % male ; median age , 58 years ; WHO performance status 0 , 1 , 2 in 25 % , 62 % , and 13 % of cases , respectively ) . Two hundred twenty-nine patients ( 91.6 % ) had a valid HRQOL assessment . The final multivariate model retained the PI , pain ( P < .0001 ) , and appetite loss ( P = .0100 ) as independent prognostic indicators of survival . CONCLUSION Results suggest that the PI , pain , and appetite loss may be independent prognostic factors in patients with advanced MPM BACKGROUND Despite the clinical benefit that may be associated with reduction of tumor volume , chemotherapy may produce physical or psychological distress that could compromise a patient 's quality of life . Although palliation may be as relevant as tumor response in patients with metastatic breast cancer , quality of life is not commonly evaluated in phase II clinical trials of new therapeutic agents . PURPOSE We evaluated the utility of quality -of-life assessment in two phase II clinical trials of patients receiving paclitaxel ( Taxol ) and recombinant human granulocyte colony-stimulating factor ( rhG-CSF ) as salvage therapy for metastatic breast cancer . METHODS A battery of instruments ( i.e. , Memorial Symptom Assessment Scale [ MSAS ] , Functional Living Index-Cancer [ FLIC ] , R and Mental Health Inventory [ MHI ] , Brief Pain Inventory [ BPI ] , and Memorial Pain Assessment Card [ MPAC ] ) design ed to capture information about social , psychological , and functional aspects of quality of life , as well as symptom prevalence and distress , was completed prior to treatment ; serial assessment s were obtained at regular intervals during the treatment period . Univariate and multivariate analyses were performed evaluating base-line quality -of-life parameters and st and ard prognostic factors in relation to outcome measures of survival , tumor response , and toxicity . For 30 consecutive patients with extensive prior chemotherapy for metastatic disease , longitudinal data were analyzed associating tumor response to changes in quality -of-life scores throughout the course of treatment with paclitaxel . RESULTS Base-line scores of two vali date d quality -of-life instruments , the MSAS and the FLIC , independently predicted the overall survival ( P < .01 for each ) . In this model , however , neither st and ard prognostic factors nor quality of life instruments predicted the likelihood of tumor response or the probability of encountering grade 3 or grade 4 nonhematologic toxicity . With serial assessment s of quality of life , the majority of patients who achieved partial tumor response or stable disease reported improved or unchanged quality -of-life scores , while those patients with progressive disease experienced rapid deterioration in quality of life . CONCLUSIONS Base-line quality -of-life assessment may provide prognostic information distinct from that obtained through st and ard prognostic indicators alone . The combination of two factors -- extent of disease and a base-line quality -of-life assessment --predicted survival more accurately than either used separately . Evaluation of quality -of-life outcomes in relation to tumor response may illuminate previously unmeasured palliative effects of chemotherapy , such as pain relief , as well as the burdens it imposes . IMPLICATION S Information obtained from quality -of-life assessment in conjunction with phase II testing of new chemotherapeutic agents for metastatic breast cancer can guide quality -of-life evaluation planned in large , r and omized future studies BACKGROUND Studies that have examined correlations between psychosocial factors and survival in cancer patients do not permit any definitive conclusions . To the authors ' knowledge , to date no study has examined the relation between medical as well as quality of life variables and survival in head and neck carcinoma patients . The current study focused on the complex interactions among psychosocial , medical , behavioral , and demographic variables as they relate to prognosis in these patients . METHODS A total of 133 consecutive head and neck carcinoma patients were included in a prospect i ve study at pretreatment . In addition to clinical variables , psychosocial and physical functioning was assessed by means of a self-report question naire . RESULTS During the observation period 57 patients died whereas 76 were still alive at 6 years after treatment . Results of the multivariate survival analysis indicated that patients without head and neck metastasis had a better prognosis than patients with positive cervical lymph nodes . Pretreatment smoking showed a negative correlation with overall survival . Patients who were more physically self-efficacious ( i.e. , higher perceived physical abilities ) were more likely to survive and less likely to develop a recurrence . In addition , patients who expressed intense psychosocial complaints prior to treatment had a better prognosis than had those who did not express such negative feelings . CONCLUSIONS The current findings linking physical self-efficacy and prognosis are promising , but clinical trials are necessary to examine the direct and indirect mediational pathways of the variables that underlie physical efficacy and influence survival and recurrence . Also , the negative correlation between pretreatment smoking and survival suggests a need for increased efforts to address smoking in newly diagnosed patients The purpose of the study was to investigate whether baseline quality of life ( QoL ) and changes in QoL scores from baseline are prognostic for time to progression ( TTP ) and /or overall survival ( OS ) in patients with advanced breast cancer receiving docetaxel ( T ) or sequential methotrexate and 5-fluorouracil ( MF ) . QoL was assessed at baseline and before each treatment using the European Organization for Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire ( QLQ-C30 ) . Survival curves and probabilities were estimated using the Kaplan-Meier technique . The Cox proportional hazards regression model was used for both the univariate and multivariate analyses to explore relationships between baseline QoL variables and TTP , as well as OS . In the univariate analysis , more severe pain and fatigue at baseline were predictive for a shorter OS ; global QoL , physical functioning and appetite loss had a borderline significance ( P=0.0130 for global QoL ; P=0.0256 for physical functioning : P=0.0149 for appetite loss ) . World Health Organization ( WHO ) performance status was significantly predictive for OS . In the multivariate analysis , more severe pain at baseline was predictive for a shorter OS . In contrast , baseline QoL had no prognostic value for the duration of TTP . QoL change scores from baseline QoL predicted neither OS nor TTP . Our findings suggest that while QoL measurements are important in evaluating patients ' QoL , they have no great importance in predicting primary clinical endpoints such as TTP or OS in advanced breast cancer patients PURPOSE Patients with symptomatic metastatic hormone-resistant prostate cancer ( HRPC ) survive a median of 10 months and are often regarded as a homogeneous group . Few prognostic factors have been identified so far . We examined whether baseline health-related quality of life ( HRQOL ) parameters assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 ( EORTC QLQ-C30 ) were independent prognostic factors of survival and whether they bring extra precision to the predictions achievable with models based on clinical and biochemical factors only . PATIENTS AND METHODS Data of 391 symptomatic ( bone ) metastatic HRPC patients from three r and omized EORTC trials were used in multivariate Cox proportional hazards models . The significance level was set at alpha = .05 . RESULTS Of the 391 patients , 371 died , most of prostate cancer . Bone scan result , performance status , hemoglobin level , and insomnia and appetite loss as measured by the EORTC QLQ-C30 were independent predictors of survival . This model 's area under the receiver operating curve was 0.65 compared with 0.63 without the two HRQOL factors . CONCLUSION Certain HRQOL sores , at baseline , seem to be predictors for duration of survival in HRPC . However , such measurements do not add to the predictive ability of models based only on clinical and biochemical factors Purpose : Patient-assessed health-related quality -of-life ( HRQOL ) scores , together with demographic and clinical factors in stage III non-small cell lung cancer ( NSCLC ) patients , are important prognostic factors for survival and may be helpful in determining thoracic radiotherapy ( TRT ) strategy . Methods : In a previously published r and omized trial , 301 patients were treated with different palliative radiotherapy schedules , comparing short-term hypofractionated TRT ( arm A : 17 Gy/2 fractions [ n = 105 ] ) with more protracted TRT ( arm B : 42 Gy/15 fractions [ n = 104 ] ) ; arm C : 50 Gy/25 fractions [ n = 92 ] ) . Baseline HRQOL , demographic , and clinical data were available for all patients . All possible prognostic factors from univariate analysis were entered into the Cox multivariate regression model to identify variables of independent prognostic relevance . Results : Overall survival was similar , whereas long-term survival was restricted to higher-dose radiotherapy with 3-year survival rates of 1 , 8 , and 6 % ( p = 0.40 ) and 5-year survival rates of 0 , 4 , and 3 % ( p = 0.12 ) in arms A , B , and C , respectively . In univariate analysis , Karnofsky performance status , use of analgesics , and weight loss were highly significant non-HRQOL factors ( p < 0.001 ) , and physical function , appetite loss , cough , and pain were the most powerful HRQOL factors ( p < 0.001 ) . In multivariate analysis , appetite loss appeared as the most powerful independent prognostic indicator . In the group of patients treated with protracted fractionation ( n = 196 ) , the 2- , 3- , and 5-year survival rates in patients with no appetite loss ( n = 95 ) were 22 % ( 21/95 ) , 12 % ( 11/95 ) , and 8 % ( 8/95 ) compared with 3 % ( 3/101 ) , 1 % ( 1/101 ) , and 1 % ( 1/101 ) in patients with appetite loss present at baseline ( n = 101 ) . Conclusion : In addition to performance status and weight loss , patient-reported appetite loss should be assessed in stage III NSCLC patients before administrating TRT ; such assessment is a valuable tool for selecting patients to normofractionated or lower-dose hypofractionated palliative TRT PURPOSE To study the prognostic value for overall survival of baseline assessment of functional status , comorbidity , and quality of life ( QoL ) in elderly patients with advanced non-small-cell lung cancer treated with chemotherapy . PATIENTS AND METHODS Data from 566 patients enrolled onto the phase III r and omized Multicenter Italian Lung Cancer in the Elderly Study ( MILES ) study were analyzed . Functional status was measured as activities of daily living ( ADL ) and instrumental ADL ( IADL ) . The presence of comorbidity was assessed with a checklist of 33 items ; items 29 and 30 of the European Organisation for Research and Treatment of Cancer ( EORTC ) core question naire QLQ-C30 ( EORTC QLQ-C30 ) were used to estimate QoL. ADL was dichotomized as none versus one or more dependency . For IADL and QoL , three categories were defined using first and third quartiles as cut points . Comorbidity was summarized using the Charlson scale . Analysis was performed by Cox model , and stratified by treatment arm . RESULTS Better values of baseline QoL ( P = .0003 ) and IADL ( P = .04 ) were significantly associated with better prognosis , whereas ADL ( P = .44 ) and Charlson score ( P = .66 ) had no prognostic value . Performance status 2 ( P = .006 ) and a higher number of metastatic sites ( P = .02 ) also predicted shorter overall survival . CONCLUSIONS Pretreatment global QoL and IADL scores , but not ADL and comorbidity , have significant prognostic value for survival of elderly patients with advanced non-small-cell lung cancer who were treated with chemotherapy . Using these scores in clinical practice might improve prognostic prediction for treatment planning BACKGROUND The possible link between psychological factors and length of cancer survival has generated a literature of contradictory findings . Associations usually have not been found when general psychological symptoms are assessed . Associations usually have been found for predictors related to expressive versus repressive emotional coping ( e.g. , depression , " fighting spirit , " hostility , and type C personality ) ; however , even these associations have been relatively small , when compared with those for medical factors . Yet few studies have adequately controlled for medical and treatment-related factors . PURPOSE Within a Cancer and Leukemia Group B ( CALGB ) national clinical trial of four adjuvant therapy regimens for stage II breast cancer ( CALGB 8082 ) , this study prospect ively examined the contribution of potential psychological predictors to length of disease-free and overall survival over a 15-year period . METHODS Subjects were 280 women with stage II breast cancer , out of a total of 899 , who were r and omly assigned to receive CMFVP ( cyclophosphamide-methotrexate-fluorouracil-vincristine-prednisone ) for two 6-week cycles or six 4-week cycles , then subsequently r and omly assigned to receive or not to receive VATH ( vinblastine-doxorubicin-thiotepa-fluoxymesterone ) . Subjects were recruited during the period between October 1980 and August 1984 , inclusive , and followed until January 1996 . Prior to chemotherapy , psychological symptoms were assessed using the Symptom Check List-90-Revised ( SCL-90-R ) . SCL-90-R scores were trichotomized into categories representing high , medium , and low distress . Basic base-line sociodemographic data ( including age , ethnicity , education , and marital status ) and medical data ( including lymph node status , estrogen receptor status , menopausal status , and performance status ) were collected . Subjects with psychosocial data differed from those without psychosocial data solely in their higher percentage of classification in the mild limitation category of the Zubrod ( Eastern Cooperative Oncology Group ) performance status rating ( subjects with psychosocial data : 14 % ; subjects without psychosocial data : 8 % ) . RESULTS In stepwise Cox regression analyses that controlled for sociodemographic and medical variables , there was no significant predictive effect of the level of distress ( as measured by the SCL-90-R trichotomized scores ) on length of disease-free and overall survival of the study subjects . Risk ratios for low versus high distress were 1.01 ( 95 % confidence interval [ CI ] = 0.62 - 1.66 ) for disease-free survival and 1.03 ( 95 % CI = 0.58 - 1.82 ) for overall survival . CONCLUSIONS This study failed to provide evidence that psychological factors contributed to length of disease-free or overall survival of women who received adjuvant chemotherapy ( either CMFVP alone or CMFVP followed by VATH ) for treatment of stage II breast cancer . IMPLICATION S In the context of far more potent medical factors , the contribution of psychological factors to disease-free and overall survival is likely to be relatively small . Future research should focus on specific theory-driven predictors rather than on general psychological symptoms . Moreover , it should be based on clinical studies using a controlled , prospect i ve design , in which the effects of medical factors may be distinguished and psychological predictors are clear antecedents of survival outcomes PURPOSE The purpose was to evaluate the health-related quality of life ( HRQL ) of patients with pharyngeal carcinoma at diagnosis and after 1 and 5 years in relation to tumor location and treatment modality in a prospect i ve multicenter study . METHODS Eighty-nine patients with pharyngeal carcinoma ( mean age , 60.0 years ; 76 % men ) were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Question naire-Core 30 ( EORTC QLQ-C30 ) and the European Organization for Research and Treatment of Cancer Quality of Life Question naire Head and Neck Cancer Module ( EORTC QLQ-H&N35 ) . RESULTS Problems with dry mouth and teeth became worse between diagnosis and the 5-year follow-up . Problems with thick secretions and teeth increased between 1 and 5 years . The HRQL at diagnosis was associated with survival . Patients with oropharyngeal carcinoma reported better HRQL than patients with hypopharyngeal carcinoma . CONCLUSIONS For patients with pharyngeal carcinoma , the HRQL at diagnosis seems to be an important factor for the prognosis of both HRQL over time and survival . Treatment of pharyngeal carcinoma often results in long-term side effects such as dry mouth , problems with teeth , and thick secretions Background Oesophageal cancer is often diagnosed at an advanced stage , with poor prognosis and severe morbidity . In majority of cases , palliative treatment is the only option available The aim of the project was to identify clinical and quality of life ( QL ) factors that together predict survival and response to chemotherapy in advanced breast cancer . Potential prognostic factors were studied in 187 women with baseline QL data from a trial of paclitaxel versus doxorubicin as first-line chemotherapy . Demographic and clinical factors studied were age , performance status , dominant site of disease and preceding disease-free interval ( DFI ) . Factors from the EORTC QLQ-C30 were all function scales , fatigue , nausea/vomiting , pain , dyspnoea , insomnia , loss of appetite and global QL . The proportional hazards regression model with stratification for treatment , and the logistic regression model adjusting for treatment arm were used for univariate and multivariate analyses of survival and response to treatment , respectively . For survival , multiple sites of visceral disease , pain , global QL and fatigue were significant prognostic factors in the univariate analysis . The final multivariate model predicted poor survival with multiple sites of visceral disease ( P=0.003 ) , DFI < /=2 years ( P=0.026 ) and pain ( P=0.003 ) . For response , age , dyspnoea , fatigue and global QL were significant predictive factors in the univariate analysis . The final multivariate model for response selected DFI ( P=0.009 ) , multiple sites of visceral disease ( P=0.037 ) and dyspnoea ( P=<0.001 ) using forward selection , but model instability was indicated by the inclusion of fatigue and emotional function in the final model when backward selection was used . In addition to known clinical factors , patient-assessed QL variables appear to be prognostic for survival and response to chemotherapy in women with advanced breast cancer . However , identification of prognostic factors from responses to question naires may be unstable , and their reliability and clinical utility should be tested prospect ively Professional and public interest in possible relationships between psychosocial factors and disease outcome continues to increase . Published research in this area , however , is marked by contradictory results . Positive relationships between a variety of psychosocial factors and length of survival from cancer are reported , but other studies uncover no such associations . In a previously reported prospect i ve investigation of 359 patients with newly diagnosed malignant diseases , we found no relationship between clinical outcome and any psychosocial factor studied . We have continued to observe these patients , who are now up to 8 years post-diagnosis , and report here additional data on their disease outcomes as they relate to psychosocial factors assessed at diagnosis . Two groups of patients were studied : 204 patients with advanced , prognostically poor malignant disease at diagnosis ; and 155 patients with intermediate or high-risk melanoma or breast cancer . Shortly after diagnosis , patients completed a self-report question naire that assessed seven psychosocial factors previously reported to predict longevity in the general population . Factors included social ties and marital history , job satisfaction , use of psychotropic drugs , general life satisfaction , subjective view of adult health , hopelessness , and perception of amount of adjustment required to cope with the new diagnosis . Clinical factors -- performance status and extent of disease at diagnosis -- predicted clinical outcome . No psychosocial factor consistently was associated with length of survival or remission . Results of additional exploratory analyses also are reported OBJECTIVE Performance status ( PS ) is an important prognostic factor in advanced ovarian cancer . The purpose of this study was to evaluate the prognostic significance of PS and quality of life ( QoL ) assessment on progression-free survival ( PFS ) and overall survival ( OS ) in patients with advanced ovarian cancer . METHODS We studied Canadian patients participating in an intergroup study in ovarian cancer ( NCIC-OV10 ) , which r and omized patients to receive either st and ard chemotherapy using cisplatin/cyclophosphamide or cisplatin/paclitaxel chemotherapy . QoL was assessed using the EORTC quality of life question naire ( QLQ-C30 + 3 ) . The effects of multiple variables including the relevant clinical variables , PS and QoL scores were analyzed by Cox stepwise regression at baseline and again 3 months after completion of chemotherapy . RESULTS At baseline and at 3 months after chemotherapy , there were 151 and 93 patients respectively who completed the QLQ-C30 + 3 question naires . Baseline PS , global QoL score and treatment were independent predictors for both PFS and OS . Baseline cognitive functioning score was also an additional independent predictor for OS . At 3 months after completion of chemotherapy global QoL score , PS and grade were significant independent predictors of OS ; however , only physical functioning score , emotional functioning score and tumor grade predicted for PFS . CONCLUSIONS Performance status and global quality of life scores at baseline are prognostic factors in advanced ovarian cancer for both PFS and OS . Higher baseline cognitive functioning scores were also associated with improved survival . Global QoL scores at 3 following completion of chemotherapy proved to be of prognostic significance for OS but not PFS Although psychologic factors have been reported to influence the progression of cancer , this theory remains controversial . A prospect i ve study of patients with advanced lung carcinoma was performed to explore the influence of the patient 's mental state on survival PURPOSE The Big Lung Trial ( BLT ) was a large , pragmatic trial to evaluate the addition of chemotherapy to primary treatment ( ie , surgery , radical radiotherapy , or supportive care ) in non-small-cell lung cancer ( NSCLC ) . In the supportive care group , there was a small but significant survival benefit in patients treated with chemotherapy compared with supportive care alone ( no chemotherapy ) . A sub study was undertaken to evaluate the quality of life ( QoL ) implication s of the treatment options . QoL was assessed using European Organisation for Research and Treatment of Cancer ( EORTC ) Quality of Life Question naires C30 ( QLQ-C30 ) and LC17 , and daily diary cards . PATIENTS AND METHODS EORTC QLQ-C30 and LC17 were collected at 0 , 6 to 8 , 12 , 18 , and 24 weeks . Diary cards were completed during the first 12 weeks of the study . The primary end point was global QoL at 12 weeks . RESULTS A total of 273 patients were r and omly assigned : 138 to no chemotherapy and 135 to chemotherapy . There was no evidence of a large detrimental effect on QoL of chemotherapy . No statistically significant differences in global QoL or physical/emotional functioning , fatigue and dyspnea , and pain were detected at 12 weeks . Higher rates of palliative radiotherapy in the no chemotherapy arm may have lessened differences in QoL. Global QoL , role functioning , fatigue , appetite loss , and constipation were prognostic indicators of survival at 12 weeks . CONCLUSION There were no important adverse effects of chemotherapy on Data from a clinical study of 86 pancreatic cancer patients with involuntary , significant weight loss ( cachexia ) were used to explore the relationship between patient-reported outcomes ( PROs ) and survival . In all , 28 pancreatic cancer patients with cachexia were given gemcitabine ( Gemzar ) plus 3 mg/kg of infliximab ( Remicade ) , 28 were given gemcitabine plus 5 mg/kg of infliximab , and 30 were given gemcitabine plus placebo in a double-blinded , phase II , multicenter trial . PRO endpoints included scores from the Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) , Functional Assessment of Anorexia/ Cachexia Therapy ( FAACT ) , Brief Pain Inventory ( BPI ) , and the Short-Form 36 general health survey ( SF-36 ) . Population mean scores at baseline indicated fatigue problems ( FACIT-F ) , nutritional health issues ( FAACT ) , and mild-to-moderate pain ( BPI " worst pain " score ) . Baseline normalized SF-36 values for physical functioning , vitality , and mental health indicated substantial impairment . Baseline fatigue and physical-functioning scores predicted survival as well as , or better than , baseline Karnofsky Performance Status or hemoglobin level . A cut-point in the FACIT-F score ( median < or = 30 ) strongly predicted mortality ; patients with greater fatigue had a lower median overall survival than did those with less fatigue . These findings supported several features of an a priori clinical -benefit model . Patient-reported fatigue provided powerful prognostic information ; tracking of this symptom may be useful for treatment planning and medical monitoring of advanced-stage pancreatic cancer patients with cachexia . These results must be confirmed by larger trials & NA ; Previous research suggesting a link between psychosocial variables and survival after bone marrow transplant ( BMT ) has been limited by : a ) retrospective assessment of psychosocial variables ; and b ) failure to concurrently examine a comprehensive set of disease , treatment , and demographic variables potentially related to post‐BMT survival . The present study prospect ively assessed psychosocial variables ( depressed mood , functional quality of life , and mental adjustment to cancer ) that have been linked to survival after BMT and /or malignant disease . Study participants ( N = 42 ) received allogeneic BMT for either acute or chronic leukemia . Analyses using Cox proportional hazards regression indicated that quality of bone marrow graft match was the only disease , treatment , or demographic variable significantly associated with post‐BMT survival ( p = .05 ) . Addition of psychosocial variables to a multivariate Cox regression model including quality of graft match suggested that an attitude toward cancer characterized by “ anxious preoccupation ” ( p = .008 ) , as well as poorer functional quality of life ( p = .052 ) , were each independently associated with poorer post‐BMT survival . Further research is necessary to identify the mechanisms by which psychosocial variables could contribute to post‐BMT survival |
1,383 | 24,305,981 | Results No evidence of superiority of any embolic agent was demonstrated .
Conclusions This study confirms that the current evidence demonstrates superiority of Embospheres over spherical PVA but no reported differences in outcomes between any of the other agents . | Purpose This study was design ed to undertake systematic review and meta- analysis of published comparative trials comparing embolic agents used in uterine artery embolisation ( UAE ) for uterine leiomyomata . | PURPOSE To prospect ively evaluate health-related quality of life ( HRQOL ) outcomes for uterine artery embolization ( UAE ) and hysterectomy up to 24 months after the intervention in terms of mental and physical health , urinary and defecatory function , and overall patient satisfaction . MATERIAL S AND METHODS Ethics committee approval and informed consent were obtained for the Embolisation versus Hysterectomy Trial . Women ( n = 177 ) with uterine fibroids and heavy menstrual bleeding who were scheduled to undergo hysterectomy were r and omly assigned to undergo UAE ( n = 88 ) or hysterectomy ( n = 89 ) . HRQOL was measured six times during a 24-month follow-up period with the following vali date d question naires : Medical Outcome Study Short Form 36 ( SF-36 ) mental component summary ( MCS ) and physical component summary ( PCS ) , Health Utilities Index Mark 3 , EuroQol 5D , urogenital distress inventory ( UDI ) , incontinence impact question naire , and defecation distress inventory ( DDI ) . Satisfaction was assessed with a seven-point Likert scale . Repeated measurement analysis was performed for between-group analysis . Paired t tests were performed for within-group analysis . Satisfaction was analyzed with the Fisher exact test . RESULTS The SF-36 MCS and PCS , Health Utilities Index Mark 3 , EuroQol 5D , and UDI scores were improved significantly in both groups at 6 months and afterward ( P < .05 ) . The DDI score was improved significantly in only the UAE group at 6 months and afterward ( P < .05 ) . No differences between groups were observed , with the exception of PCS scores at 6-week follow-up : Patients in the UAE group had significantly better scores than did patients in the hysterectomy group ( P < .001 ) . Improvement in PCS score at 24-month follow-up was significantly higher for patients who were employed at baseline ( P = .035 ) . At 24-month follow-up , patients in the hysterectomy group were significantly more satisfied than those in the UAE group ( P = .02 ) . CONCLUSION Both UAE and hysterectomy improved HRQOL . No differences were observed between groups regarding HRQOL at 24-month follow-up . On the basis of HRQOL results , the authors determined that UAE is a good alternative to hysterectomy OBJECTIVE The purpose of this study was to evaluate the long-term outcomes of uterine artery embolization using only gelatin sponge particles for symptomatic fibroids . MATERIAL S AND METHODS As part of an ongoing study of the procedure for fibroids , prospect i ve data of the initial 96 consecutive women treated between December 1997 and December 2001 , were collected in January 2005 . It had been more than 3 years since embolization in all cases . The follow-up period ranged from 4 to 60 months ( mean , 37.4 months ) . On the basis of serial question naires , we investigated the cumulative rates of symptom control , gynecologic interventions , and overall failure , using the Kaplan-Meier product limit estimator . Symptom control was defined as meaning patients whose symptoms had improved as indicated on the last question naire and who had not undergone any further gynecologic intervention because of symptoms . Overall failure was defined as meaning the patients who indicated that there had been no symptom improvement or recurrence or that they had undergone further gynecologic interventions . RESULTS Of all 96 women , 16 ( 17 % ) were lost to follow-up during the period . Cumulative rates of symptom control were 96.9 % at 1 year , 89.5 % at 3 years , and 89.5 % at 5 years . Cumulative rates of complications related to the gynecologic intervention and overall gynecologic interventions were 2.1 % and 4.2 % , respectively , at 1 year , 2.1 % and 5.4 % at 3 years , and 2.1 % and 10.5 % at 5 years . Cumulative rates of overall failure were 4.2 % at 1 year , 12.7 % at 3 years , and 12.7 % at 5 years . Major complications were noted in 3.1 % ( 3/96 ) . Of these three women , two required hospitalization for transvaginal resection of sloughing fibroids and one developed sexual dysfunction . Two women became pregnant , but both pregnancies result ed in miscarriage . CONCLUSION Uterine artery embolization using gelatin sponge particles alone can achieve long-term symptom control for fibroids in most cases AIM The purpose of this study was to compare the depth of vascular penetration of non-spherical polyvinyl alcohol ( PVA ) versus trisacryl gelatin microspheres ( MS ) in women undergoing uterine artery embolization ( UAE ) immediately before transabdominal myomectomy . MATERIAL S AND METHODS A total of 17 patients who had been referred for embolization before myomectomy underwent bilateral uterine artery embolization using either 355 - 500 microm PVA ( group A ) or 700 - 900 microm MS ( group B ) . The depth of penetration of the particles was assessed by identifying their presence and location in the resected specimen . RESULTS Of the 17 women enrolled in this study , 10 were in group A and 6 in group B. One woman underwent embolization using both types of particle and was excluded from the analysis . Embolic particles were significantly ( p = 0.048 ) more frequently located within the fibroid ( 4/6 , 67 % ) in Group B than Group A ( 1/10 , 10 % ) . Particles were also identified in the perifibroid tissues in 4/6 ( 67 % ) in Group B and 4/10 ( 40 % ) in Group A , with no statistical difference . There were no procedural complications . CONCLUSION MS particles ( 700 - 900 microm ) penetrate significantly deeper into leiomyomata compared with non-spherical PVA ( 355 - 500 microm ) . MS may therefore confer advantages in UAE , as they may more specifically target the fibroid , allowing an earlier end-point to embolization and minimizing ischaemic damage to normal myometrium and ovaries BACKGROUND The efficacy and safety of uterine-artery embolization , as compared with st and ard surgical methods , for the treatment of symptomatic uterine fibroids remain uncertain . METHODS We conducted a r and omized trial comparing uterine-artery embolization and surgery in women with symptomatic uterine fibroids . The primary outcome was quality of life at 1 year of follow-up , as measured by the Medical Outcomes Study 36-Item Short-Form General Health Survey ( SF-36 ) . RESULTS Patients were r and omly assigned in a 2:1 ratio to undergo either uterine-artery embolization or surgery , with 106 patients undergoing embolization and 51 undergoing surgery ( 43 hysterectomies and 8 myomectomies ) . There were no significant differences between groups in any of the eight components of the SF-36 scores at 1 year . The embolization group had a shorter median duration of hospitalization than the surgical group ( 1 day vs. 5 days , P<0.001 ) and a shorter time before returning to work ( P<0.001 ) . At 1 year , symptom scores were better in the surgical group ( P=0.03 ) . During the first year of follow-up , there were 13 major adverse events in the embolization group ( 12 % ) and 10 in the surgical group ( 20 % ) ( P=0.22 ) , mostly related to the intervention . Ten patients in the embolization group ( 9 % ) required repeated embolization or hysterectomy for inadequate symptom control . After the first year of follow-up , 14 women in the embolization group ( 13 % ) required hospitalization , 3 of them for major adverse events and 11 for reintervention for treatment failure . CONCLUSIONS In women with symptomatic fibroids , the faster recovery after embolization must be weighed against the need for further treatment in a minority of patients . ( IS RCT N.org number , IS RCT N23023665 [ controlled-trials.com ] . PURPOSE To compare tris-acryl microspheres and polyvinyl alcohol ( PVA ) microspheres as embolic agents in uterine artery embolization ( UAE ) for uterine leiomyomas in terms of clinical outcome , inflammatory response , and adverse reactions . MATERIAL S AND METHODS A double-blinded r and omized controlled trial was performed , with 27 patients in the tris-acryl microsphere group and 29 in the PVA microsphere group . The primary endpoint was clinical success , defined as a 2-year freedom from subsequent surgery as a result of persistent or deteriorated symptoms . Secondary endpoints included ( i ) posttreatment leiomyoma enlargement , ( ii ) leiomyoma volume reduction at 3 and 9 months , ( iii ) significant residual intratumoral perfusion , ( iv ) increase in inflammatory and stress markers , ( v ) incidence of complications , and ( vi ) duration of hospital stay . RESULTS There was no statistically significant difference between the two groups in patient demographics , clinical presentation , initial tumor findings , change in inflammatory and stress markers after treatment , incidence of complications , and duration of hospital stay . Tris-acryl microspheres were associated with a higher rate of clinical success than PVA microspheres ( 96.3 % [ 26 of 27 ] vs 69 % [ 20 of 29 ] ; P = .012 ) , a lower incidence of posttreatment leiomyoma enlargement ( P = .030 ) , and a lower incidence of significant residual intratumoral perfusion ( P = .030 ) . CONCLUSIONS In the treatment of uterine leiomyomas , UAE with tris-acryl microspheres was associated with a higher clinical success rate , a lower incidence of tumor enlargement , and no significant differences in adverse reactions and inflammatory response compared with the use of PVA microspheres . Tris-acryl microspheres therefore represent the preferred agent for UAE of uterine leiomyomas Objective To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres ( a-PVAM ) as an embolic agent for uterine artery embolization ( UAE ) compared with Tris-acryl gelatin microspheres ( TAGM ) . Design , Setting , Participants Prospect i ve r and omized double-blind noninferiority trial . Conducted at two sites both with regional UAE practice s. Forty-six women with symptomatic leiomyomas . InterventionUAE procedure was performed with either of the two embolic agents . Either 700–900-μm a-PVAM or 500–700-μm TAGM was used . Main Outcome Measures Changes in leiomyoma perfusion , overall uterine volume , and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week , 3 months , and 6 months after UAE by a reader blinded to the embolic agent used . Changes in Uterine Fibroid Symptoms and Quality of Life question naire scores were measured at 3 , 6 , and 12 months after UAE . Results Forty-six patients were r and omized and treated under the study protocol ( a-PVAM n = 22 , TAGM n = 24 ) . There were no procedure-related complications . Two patients were excluded from analysis ( one technical failure of the procedure , one withdrawal from study ) . Successful ( > 90 % ) leiomyoma devascularization was observed in 81 % of subjects at 1 week after UAE , 97 % at 3 months after UAE , and 95 % at 6 months after UAE . No significant differences were observed in 14 of 15 outcome measurements , consistent with noninferiority . TAGM was slightly superior to a-PVAM on one comparison ( overall quality of life at 3 months after UAE ) PURPOSE To report the 12-month clinical and magnetic resonance ( MR ) imaging results of an ongoing two-center registry involving acrylamido polyvinyl alcohol ( PVA ) microspheres for uterine artery embolization ( UAE ) for leiomyomas . MATERIAL S AND METHODS A total of 69 patients underwent UAE with 500 - 700-microm , 700 - 900-microm , and 900 - 1,200-mum acrylamido PVA microspheres ( BeadBlock ) . Thirty-three patients underwent UAE with a limited embolization ( protocol A ) and 36 patients underwent UAE with stasis as the angiographic endpoint ( protocol B ) . Primary objectives were clinical efficacy measured by a leiomyoma-specific quality of life ( QOL ) question naire and infa rct ion rate of leiomyomas on early contrast agent-enhanced MR imaging . Secondary objectives were in-hospital complications , patient satisfaction , and frequency of clinical failure . RESULTS Bilateral embolization was technically successful in 68 of 69 patients . A significant decrease ( P < .001 ) in symptom severity and increase in health-related QOL was observed at 3 and 12 months with no significant differences between embolization protocol s. However , contrast agent-enhanced MR imaging showed a significantly lower rate of completely infa rct ed leiomyomas in protocol A compared with protocol B ( P < .05 ) . Early clinical failures in patients treated according to protocol A were caused by incomplete tumor infa rct ion . Minor complications occurred in five of 69 patients . Patient satisfaction was similar between protocol s. CONCLUSIONS Acrylamido PVA microspheres are a clinical ly effective and safe embolic agent for UAE . The use of 500 - 700-microm spheres and a limited embolization results in an unacceptably high rate of failed tumor infa rct ion . Superior imaging results and fewer repeat interventions can be achieved with use of 700 - 900-microm spheres and stasis as the angiographic endpoint Purpose This study was design ed to compare quality of life ( QoL ) outcomes after uterine artery embolization ( UAE ) or myomectomy . Methods Women with symptomatic fibroids diagnosed by ultrasound who wished to preserve their uterus were r and omized to myomectomy ( n = 81 ) or UAE ( n = 82 ) . Endpoints at 1 year were QoL measured by a vali date d question naire , hospital stay , rates of complications , and need for reintervention . Results UAE patients had shorter hospitalization ( 2 vs. 6 days , p < 0.001 ) . By 1 year postintervention , significant and equal improvements in QoL scores had occurred in both groups ( myomectomy n = 59 ; UAE n = 61 ) . There had been two ( 2.9 % ) major complications among UAE versus 6 ( 8 % ) among myomectomy patients ( not significant ) . By 2 years , among UAE patients ( n = 57 ) there were eight ( 14.0 % ) re interventions for inadequate symptom control compared with one ( 2.7 % ) among myomectomy patients ( n = 37 ) . Half of the women who required hysterectomy had concomitant adenomyosis missed by US . Conclusions UAE and myomectomy both result in significant and equal improvements in QoL. UAE allows a shorter hospital stay and fewer major complications but with a higher rate of reintervention PURPOSE To assess symptom reduction and follow-up magnetic resonance ( MR ) imaging findings in patients who have undergone uterine artery embolization ( UAE ) for symptomatic leiomyomas with the use of Bead Block . MATERIAL S AND METHODS Symptomatic patients with uterine leiomyomas were treated with UAE with Bead Block . Degree of tumor infa rct ion was assessed 3 months after treatment with contrast material -enhanced MR imaging . Each case was categorized as showing less than 25 % infa rct ion , 25%-89 % infa rct ion , or at least 90 % infa rct ion . Imaging-based failure was defined as tumor infa rct ion of less than 90 % ( 12 ) . Symptom and quality status were determined by scores from symptom and quality of life ( QOL ) and health-related QOL question naires collected 1 and 3 months after embolization . RESULTS This prospect i ve trial enrolled 23 patients . Three-month follow-up MR imaging was completed in 22 patients . Tumor necrosis of 90 % or greater occurred in 10 of 22 patients ( 45 % ) , and 12 ( 54 % ) had partial necrosis of 25%-89 % . The QOL subscale evaluation showed significant reduction of symptom severity from baseline to 1 month after treatment ( P < .0001 ) , with no significant difference between 1 and 3 months of follow-up ( P = .42 ) . Because of the unacceptably high imaging failure rate of 54 % , enrollment was terminated before the anticipated 30-patient goal . CONCLUSIONS The use of Bead Block in the manner described result ed in significant clinical improvement . However , there was an unacceptably high rate of imaging failure under the existing protocol . Modification of the existing protocol should be considered OBJECTIVE To create and vali date a question naire for assessing symptom severity and symptom impact on health‐related quality of life for women with leiomyomata . METHODS The question naire was derived from focus groups of women with leiomyomata . Content validity was established through cognitive debriefings of women with leiomyomata and review by expert clinicians . Patients for the validation study were recruited from five gynecologists ' offices , an interventional radiology department , and a University campus . Instruments used for validation were the Short Form‐36 , Menorrhagia Question naire , the Revicki‐Wu Sexual Function Scale , and a physician and a patient assessment of severity . Item and exploratory factor analysis were performed to assess the subscale structure of the question naire . Psychometric evaluation was conducted to assess reliability and validity . Test‐retest was performed on a r and om subset of the sample within 2 weeks of the initial visit . RESULTS A total of 110 patients with confirmed leiomyomata and 29 normal subjects participated in the validation . The final question naire consists of eight symptom questions and 29 health‐related quality of life questions with six subscales . Subscale Cronbach 's α ranged from 0.83 to 0.95 , with the overall health‐related quality of life score α = 0.97 . The Uterine Fibroid Symptom and Quality of Life ( UFS‐QOL ) question naire subscales discriminated not only from normal controls but also among leiomyomata patients with varying degrees of symptom severity . Test‐retest reliability was good with intraclass correlation coefficients of 0.76–0.93 . CONCLUSION The UFS‐QOL appears to be a useful new tool for detecting differences in symptom severity and health‐related quality of life among patients with uterine leiomyomata . Additional study is underway to determine the responsiveness of the UFS‐QOL to therapies for leiomyomata PURPOSE To compare the efficacy of spherical polyvinyl alcohol ( PVA ) particles versus conventional PVA particles for uterine artery embolization ( UAE ) . MATERIAL S AND METHODS Of 149 patients with 1-year follow-up after UAE , 96 received conventional PVA particles and 53 received spherical PVA particles . Severity of symptoms was ranked on an 11-point numeric rating scale ( 0 - 10 ) . The changes in severity of symptoms after embolization , blood hemoglobin level , and the size of the dominant tumor depicted by ultrasonography were used to assess the efficacy of the two types of particles . The number of hysterectomies and myomectomies in each group was also recorded as evidence of UAE failure . RESULTS On 1-year follow-up , patients treated with conventional PVA showed average numeric rating scale score improvements of 4.6 in menorrhagia , 2.9 in dysmenorrhea , 3.7 in pressure sensation , and 3.4 in urinary frequency . With spherical PVA , the average improvements were 3.0 in menorrhagia , 2.4 in dysmenorrhea , 3.1 in pressure sensation , and 2.0 in urinary frequency . Except in dysmenorrhea , all differences were significant ( P < .001 ) . With conventional PVA , there was an 8-mg/mL increase in blood hemoglobin level versus a 3-mg/mL increase with spherical PVA ( P < .05 ) . With conventional PVA , there was a 28-mm ( 34 % ) average reduction in diameter of the dominant tumor versus a 15.7-mm ( 19 % ) reduction with spherical PVA ( P = .01 ) . Eight of 96 patients ( 8 % ) treated with conventional PVA underwent hysterectomy or myomectomy during the entire length of the study , versus six of 53 patients ( 11 % ) treated with spherical PVA ( P = .6 ) . No patient underwent multiple embolizations . CONCLUSIONS In comparison with conventional PVA particles , UAE with the use of spherical PVA particles result ed in less fibroid tumor shrinkage and less improvement in clinical symptoms PURPOSE To determine the degree of leiomyoma infa rct ion after uterine artery embolization ( UAE ) performed with tris-acryl gelatin microspheres or polyvinyl alcohol ( PVA ) microspheres . MATERIAL S AND METHODS Patients determined to be c and i date s and scheduled for UAE were r and omized prospect ively to receive tris-acryl gelatin microspheres or PVA microspheres . The manufacturers ' recommended technique was used for both products during the UAE procedures ( including the recently described refined protocol for PVA microspheres ) . All patients underwent magnetic resonance ( MR ) imaging of the pelvis with contrast agent enhancement before and after the UAE procedure . On the postprocedural MR study , the degree of tumor infa rct ion was assessed on postcontrast images . These findings were classified as follows : 100 % infa rct ion , 90%-99 % infa rct ion , 50%-89 % infa rct ion , and less than 50 % infa rct ion . Treatment failure was defined by enhancement of more than 10 % of a patient 's entire tumor burden . RESULTS A total of 53 patients were enrolled in this study . Twenty-seven ( mean age , 44.9 years ) received PVA microspheres and 26 ( mean age , 45.1 years ) received tris-acryl gelatin microspheres . There were no significant differences in the preprocedural uterine volume , dominant tumor volume , location of dominant tumor , and presenting symptoms between population s. In the PVA microsphere group , treatment failure was seen in eight patients ( 29.6 % ) . In the tris-acryl gelatin microsphere group , treatment failure was seen in one patient ( 3.8 % ) , which was a significant difference between groups ( P < or = .025 ) . CONCLUSIONS There was a significantly greater degree of tumor infa rct ion in patients treated with tris-acryl gelatin microspheres during UAE than in patients who received PVA microspheres administered in accordance with a newly refined protocol . Given the known risk of recurrence in patients with persistent tumor enhancement after UAE , it is concluded that tris-acryl gelatin microspheres should be the preferred agent for UAE at this time PURPOSE To compare the outcomes of uterine artery embolization ( UAE ) for leiomyomas with use of tris-acryl gelatin microspheres ( TAGM ) versus spherical polyvinyl alcohol ( PVA ) particles . MATERIAL S AND METHODS Patients undergoing UAE were r and omly assigned to receive TAGMs or PVA . Embolization was performed in a st and ardized manner . Outcome data were collected at 3 months after embolization , including assessment of clinical symptoms , scores from a fibroid tumor-specific symptom and quality of life ( QOL ) question naire , and findings on contrast material -enhanced magnetic resonance ( MR ) imaging , including the degree of tumor infa rct ion and volume reduction . Data were analyzed with use of t tests , the Mann-Whitney U test , and chi2 tests as appropriate . RESULTS Thirty-six patients were treated . There were no differences in the two treatment groups at baseline . Clinical follow-up was obtained in 35 patients . Among the clinical outcome measures , QOL score improvement was greater for UAE with TAGMs compared with PVA ( 49.0 vs 27.9 ; P = .02 ) , but no other differences were noted . Of the 25 patients in whom 3-month MR imaging follow-up was completed , those treated with TAGM were significantly more likely to have complete infa rct ion of all leiomyomas ( six patients vs one patient ; P = .02 ) , were more likely to have at least 90 % tumor infa rct ion ( eight patients vs four patients ; P = .03 ) , and had a lower mean percent of residual perfused fibroid tumor tissue ( 9.6 % vs 44.3 % ; P = .004 ) compared with patients treated with PVA . Based on these differences between the embolic agents , enrollment in this study was terminated . CONCLUSION The use of spherical PVA particles in the manner described herein results in an unacceptably high rate of failed tumor infa rct ion in UAE |
1,384 | 26,500,478 | So far focusing essentially on abnormal eating , these studies suggest that tDCS ( right prefrontal anode/left prefrontal cathode ) reduces food craving induced by visual stimuli .
Conclusions : Despite method ological and technical differences between studies , the results are promising . | Objectives : Behavioral addictions ( BA ) are complex disorders for which pharmacological and psychotherapeutic treatments have shown their limits .
Non-invasive brain stimulation , among which transcranial direct current stimulation ( tDCS ) , has opened up new perspectives in addiction treatment .
The purpose of this work is to conduct a critical and systematic review of tDCS efficacy , and of technical and method ological considerations in the field of BA . | OBJECTIVE Because neuroimaging studies have shown that cue-provoked smoking craving is associated with changes in the activity of the bilateral dorsolateral prefrontal cortex ( DLPFC ) , we aim ed to investigate whether a powerful technique of noninvasive brain stimulation , transcranial direct current stimulation ( tDCS ) , reduces cue-provoked smoking craving as indexed by a visual analog scale . METHOD We performed a r and omized , sham-controlled crossover study in which 24 subjects received sham and active tDCS ( anodal tDCS of the left and right DLPFC ) in a r and omized order . Craving was induced by cigarette manipulation and exposure to a smoking video . The study ran from January 2006 to October 2006 . RESULTS Smoking craving was significantly increased after exposure to smoking-craving cues ( p < .0001 ) . Stimulation of both left and right DLPFC with active , but not sham , tDCS reduced craving significantly when comparing craving at baseline and after stimulation , without ( p = .007 ) and with ( p = .005 ) smoking-craving cues . There were no significant mood changes in any of the conditions of stimulation . Adverse events were mild and distributed equally across all treatment conditions . CONCLUSIONS Our findings extend the results of a previous study on the use of brain stimulation to reduce craving , showing that cortical stimulation with tDCS is beneficial for reducing cue-provoked craving , and thus support the further exploration of this technique for smoking cessation BACKGROUND Functional neuroimaging studies have shown that specific brain areas are associated with alcohol craving including the dorsolateral prefrontal cortex ( DLPFC ) . We tested whether modulation of DLPFC using transcranial direct current stimulation ( tDCS ) could alter alcohol craving in patients with alcohol dependence while being exposed to alcohol cues . METHODS We performed a r and omized sham-controlled study in which 13 subjects received sham and active bilateral tDCS delivered to DLPFC ( anodal left/cathodal right and anodal right/cathodal left ) . For sham stimulation , the electrodes were placed at the same positions as in active stimulation ; however , the stimulator was turned off after 30s of stimulation . Subjects were presented videos depicting alcohol consumption to increase alcohol craving . RESULTS Our results showed that both anodal left/cathodal right and anodal right/cathodal left significantly decreased alcohol craving compared to sham stimulation ( p<0.0001 ) . In addition , we found that following treatment , craving could not be further increased by alcohol cues . CONCLUSIONS Our findings showed that tDCS treatment to DLPFC can reduce alcohol craving . These findings extend the results of previous studies using noninvasive brain stimulation to reduce craving in humans . Given the relatively rapid suppressive effect of tDCS and the highly fluctuating nature of alcohol craving , this technique may prove to be a valuable treatment strategy within the clinical setting We aim ed to assess whether modulation of the dorsolateral prefrontal cortex ( DLFPC ) with noninvasive brain stimulation , namely transcranial direct current stimulation ( tDCS ) , modifies food craving in healthy subjects . We performed a r and omized sham-controlled cross-over study in which 23 subjects received sham and active tDCS ( anode left/cathode right and anode right/cathode left ) of the DLPFC . Subjects were exposed to food and also watched a movie of food associated with strong craving . Desire for food consumption was evaluated by visual analogue scales ( VAS ) and food consumption before and after treatment . In addition we measured visual attention to food using an eye tracking system . Craving for viewed foods as indexed by VAS was reduced by anode right/cathode left tDCS . After sham stimulation , exposure to real food or food-related movie increased craving ; whereas after anode left/cathode right tDCS , the food-related stimuli did not increase craving levels , as revealed by the VAS scale . Moreover , compared with sham stimulation , subjects fixated food-related pictures less frequently after anode right/cathode left tDCS and consumed less food after both active stimulation conditions . These changes were not related to mood changes after any type of tDCS treatment . The effects of tDCS on food craving might be related to a modulation of neural circuits associated with reward and decision-making Drug-related cues induce craving , which may perpetuate drug use or trigger relapse in addicted individuals . Craving is also under the influence of other factors in daily life , such as drug availability and self-control . Neuroimaging studies using drug cue paradigms have shown frontal lobe involvement in this context ual influence on cue reactivity , but have not clarified how and which frontal area accounts for this phenomenon . We explored frontal lobe contributions to cue-induced drug craving under different intertemporal drug availability conditions by combining transcranial magnetic stimulation and functional magnetic resonance imaging in smokers . We hypothesized that the dorsolateral prefrontal cortex ( DLPFC ) regulates craving during changes in intertemporal availability . Subjective craving was greater when cigarettes were immediately available , and this effect was eliminated by transiently inactivating the DLPFC with transcranial magnetic stimulation . Functional magnetic resonance imaging demonstrated that the signal most proportional to subjective craving was located in the medial orbitofrontal cortex across all context s , whereas the DLPFC most strongly encoded intertemporal availability information . The craving-related signal in the medial orbitofrontal cortex was attenuated by inactivation of the DLPFC , particularly when cigarettes were immediately available . Inactivation of the DLPFC also reduced craving-related signals in the anterior cingulate and ventral striatum , areas implicated in transforming value signals into action . These findings indicate that DLPFC builds up value signals based on knowledge of drug availability , and support a model wherein aberrant circuitry linking dorsolateral prefrontal and orbitofrontal cortices may underlie addiction BACKGROUND Modulation of the serotonergic system affects long-term potentiation ( LTP ) and long-term depression ( LTD ) , the likely neurophysiologic derivates of learning and memory formation , in animals and slice preparations . Serotonin-dependent modulation of plasticity has been proposed as an underlying mechanism for depression . However , direct knowledge about the impact of serotonin on neuroplasticity in humans is missing . Here we explore the impact of the serotonin reuptake blocker citalopram on plasticity induced by transcranial direct current stimulation ( tDCS ) in humans in a single-blinded , placebo-controlled , r and omized crossover study . METHODS In 12 healthy subjects , anodal excitability-enhancing or cathodal excitability-diminishing tDCS was applied to the motor cortex under a single dose of 20-mg citalopram or placebo medication . Motor cortex excitability was monitored by single-pulse transcranial magnetic stimulation ( TMS ) . RESULTS Under placebo medication , anodal tDCS enhanced , and cathodal tDCS reduced , excitability for about 60 - 120 min . Citalopram enhanced and prolonged the facilitation induced by anodal tDCS , whereas it turned cathodal tDCS-induced inhibition into facilitation . CONCLUSIONS Serotonin has a prominent impact on neuroplasticity in humans , which is in favor for facilitatory plasticity . Taking into account serotonergic hypoactivity in depression , this might explain deficits of learning and memory formation . Moreover , the results suggest that for therapeutic brain stimulation in depression and other neuropsychiatric diseases ( e.g. , in neurorehabilitation ) , serotonergic reinforcement may enhance facilitatory aftereffects and thereby increase the efficacy of these tools Food craving can be defined as the " urge to eat a specific food " . Previous findings suggest impairment of inhibitory control , specifically a regulatory deficit in the lateral prefrontal circuitry that is associated with a compulsion for food . As demonstrated by three previous studies , bilateral transcranial direct current stimulation ( tDCS ) of the dorsolateral prefrontal cortex ( DLPFC ) ( anode right/cathode left ) reduces food craving and caloric intake . We design ed the present study to evaluate the neural mechanisms that underlie these effects . We replicated the design of one of these previous studies but included electroencephalographic assessment s to register evoked potentials in a Go/No-go task that contained pictures of food and furniture ( a control visual stimulus ) . We collected data from nine women ( mean age = 23.4 ± 2 years ) in a crossover experiment . We observed that active DLPFC tDCS ( anode right/cathode left ) , compared with sham stimulation , reduced the frontal N2 component and enhanced the P3a component of responses to No-go stimuli , regardless of the stimulus condition ( food or furniture ) . Active tDCS was also associated with a reduction in caloric intake . We discuss our findings in the context of cortico-subcortical processing of craving and tDCS effects on inhibitory control neural circuitry Bulimia nervosa , binge-eating disorder , and some forms of obesity are characterised by compulsive overeating that is often precipitated by food craving . Transcranial direct current stimulation ( tDCS ) has been used to suppress food cravings , but there is insufficient evidence to support its application in clinical practice . Furthermore , the potential moderating role of impulsivity has not been considered . This study used a r and omised within-subjects crossover design to examine whether a 20-minute session of sham-controlled bilateral tDCS to the dorsolateral prefrontal cortex ( anode right/cathode left ) would transiently modify food cravings and temporal discounting ( TD ; a measure of choice impulsivity ) in 17 healthy women with frequent food cravings . Whether the effects of tDCS on food craving were moderated by individual differences in TD behaviour was also explored . Participants were exposed to food and a film of people eating , and food cravings and TD were assessed before and after active and sham stimulation . Craving for sweet but not savoury foods was reduced following real tDCS . Participants that exhibited more reflective choice behaviour were more susceptible to the anti-craving effects of tDCS than those that displayed more impulsive choice behaviour . No differences were seen in TD or food consumption after real versus sham tDCS . These findings support the efficacy of tDCS in temporarily lowering food cravings and identify the moderating role of TD behaviour Study ing social behavior often requires the simultaneous interaction of many subjects . As yet , however , no painless , noninvasive brain stimulation tool existed that allowed the simultaneous affection of brain processes in many interacting subjects . Here we show that transcranial direct current stimulation ( tDCS ) can overcome these limits . We apply right prefrontal cathodal tDCS and show that subjects ' propensity to punish unfair behavior is reduced significantly BACKGROUND The dorsolateral prefrontal cortex ( DLPFC ) plays an important role in appetite and food intake regulation . OBJECTIVE Because previous data revealed that transcranial direct current stimulation ( tDCS ) of the DLPFC reduces food cravings , we hypothesized that repetitive electric stimulation of the right DLPFC would lower food intake behavior in humans . DESIGN In a single-blind , code-based , placebo-controlled , counterbalanced , r and omized crossover experiment , 14 healthy young men with body mass index ( in kg/m(2 ) ) from 20 to 25 were examined during 8 d of daily tDCS or a sham stimulation . After tDCS or sham stimulation on the first and the last day of both experimental conditions , participants consumed food ad libitum from a st and ardized test buffet . RESULTS One week of daily anodal tDCS reduced overall caloric intake by 14 % in comparison with sham stimulation . Moreover , repetitive tDCS diminished self-reported appetite scores . CONCLUSION Our study implies that the application of anodal direct currents to the right DLPFC represents a promising option for reducing both caloric intake and appetite in humans . This trial was registered at the German Clinical Trials Register ( www.germanctr.de ) as DRKS00005811 OBJECTIVE Brain polarization in the form of transcranial direct current stimulation ( tDCS ) , which influences motor function and learning processes , has been proposed as an adjuvant strategy to enhance training effects in Neurorehabilitation . Proper testing in Neurorehabilitation requires double-blind sham-controlled study design s. Here , we evaluated the effects of tDCS and sham stimulation ( SHAM ) on healthy subjects and stroke patients ' self-report measures of attention , fatigue , duration of elicited sensations and discomfort . METHODS tDCS or SHAM was in all cases applied over the motor cortex . Attention , fatigue , and discomfort were self rated by study participants using visual analog scales . Duration of perceived sensations and the ability to distinguish tDCS from Sham sessions were determined . Investigators question ing the patients were blind to the intervention type . RESULTS tDCS and SHAM elicited comparably minimal discomfort and duration of sensations in the absence of differences in attention or fatigue , and could not be distinguished from SHAM by study participants nor investigators . CONCLUSIONS Successful blinding of subjects and investigators and ease of application simultaneously with training protocol s supports the feasibility of using tDCS in double-blind , sham-controlled r and omized trials in clinical Neurorehabilitation . SIGNIFICANCE tDCS could evolve into a useful tool , in addition to TMS , to modulate cortical activity in Neurorehabilitation This study examined whether a 20-min session of prefrontal transcranial direct current stimulation ( tDCS ) ( anode over the right prefrontal cortex and cathode over the left prefrontal cortex ) would reduce food cravings and increase the self-reported ability to resist foods in 19 healthy individuals who reported frequent food cravings . Participants viewed computerized images of food and used computerized visual analogue scales to rate food cravings and inability to resist foods before , during , and after receiving either real or sham tDCS . This study employed a r and omized within-subject crossover design ; participants received both real and sham tDCS and were blind to the condition . Food cravings ratings were reduced in both conditions , however , the percent change in cravings ratings from pre- to post-stimulation was significantly greater for real stimulation than for sham . The percent change in inability to resist food from pre- to post-stimulation also showed a greater decrease in the real condition than for sham . Post hoc analyses suggest that active prefrontal tDCS acutely and significantly decreased food cravings ratings for sweet foods and carbohydrates more so than sham tDCS . No significant differences were seen in the amount of food ingested between real and sham tDCS . These findings in healthy subjects indicate that tDCS is able to temporarily reduce food cravings and improve the self-reported ability to resist foods Transcranial Direct Current Stimulation ( tDCS ) has been shown to reduce acute substance craving in drug addicts , and improve cognition in neuropsychiatric patients . Here we aim ed to explore further tDCS induced behavioral and neurophysiological modulation including assessment of relapse rate over a prolonged time course in alcoholism . We examined the effects of repeated anodal tDCS ( 2mA , 35 cm(2 ) , 20min ) over the left dorsolateral prefrontal cortex ( DLPFC ) on relapse to the use of alcohol in alcoholics from outpatient services , who received additional routine clinical treatment . Furthermore , event related potentials ( ERPs ) , cognitive and frontal executive processes , craving , depressive and anxiety symptoms were obtained before and after treatment . From thirteen alcoholic subjects , seven were r and omized to sham-tDCS and six to real tDCS treatment ( once a week for five consecutive weeks ) . Depressive symptoms and craving were reduced to a larger extent in the tDCS group compared to the sham group ( p=0.005 and p=0.015 , respectively ) . On the other h and , active tDCS was able to block the increase in neural activation triggered by alcohol related and neutral cues in prefrontal cortex ( PFC ) as indexed by ERP as seen in the sham-tDCS group . Finally , there was a trend for increased change in executive function in the tDCS group compared to the sham-tDCS group ( p=0.082 ) , and , similarly , a trend for more relapses in the tDCS group compared to sham tDCS ( four alcoholic subjects ( 66.7 % ) vs. one ( 14.3 % ) , p=0.053).These results confirm the previous findings of tDCS effects on craving in alcoholism and also extend these findings as we showed also tDCS-related mood improvement . However , potential increase in relapse is possible ; thus the clinical value of an increase in craving and improvement in depression and executive function needs to be carefully assessed in further studies ; including investigation of optimal parameters of stimulation BACKGROUND Existing treatments for adults with anorexia nervosa ( AN ) have limited proven efficacy . New treatments that have been suggested involve targeted , brain-directed interventions such as transcranial direct current stimulation ( tDCS ) . We describe findings from seven individuals with treatment-resistant AN who received 10 sessions of anodal tDCS , over the left dorsolateral prefrontal cortex ( DLPFC ) . MATERIAL AND METHOD In this open-label , single-arm study , seven patients received anodal tDCS ( 2mA ) for 25 minutes over the left dorsolateral prefrontal cortex daily for ten days . Assessment s pre-tDCS , post-tDCS and one month later included the Eating Attitude Test ( EAT ) , Eating Disorder Inventory ( EDI ) and Beck Depression Inventory ( BDI ) . RESULTS Three patients improved in all three rating scales immediately after the treatment sessions and one month later . Two patients showed improvement at the end of treatment but returned to the baseline after one month . One subject improved only on the BDI scale but not eating scales . The scores in the three rating scales were unaffected by treatment in the remaining patient . There was a significant effect of time ( pre , post and 1 month later ) on the three rating scores ; BDI ( P = 0.016 ) , EDI ( P = 0.018 ) and EAT ( P = 0.016 ) and a significant correlation between the percent improvement of BDI and EAT ( p = 0.01 ) , and between BDI and EDI ( P = 0.006 ) . CONCLUSIONS These findings suggest that tDCS has potential as an adjuvant treatment for AN and deserves further study |
1,385 | 21,655,420 | After ankle sprain , there is evidence for the use of functional support and non-steroidal anti-inflammatory drugs .
There is weak evidence suggesting that the use of manual therapy may lead to positive short-term effects .
Electro-physical agents do not appear to enhance outcomes and are not recommended .
Exercise may reduce the occurrence of recurrent ankle sprains and may be effective in managing chronic ankle instability .
After surgical fixation for ankle fracture , an early introduction of activity , administered via early weight-bearing or exercise during the immobilization period , may lead to better outcomes .
However , the use of a brace or orthosis to enable exercise during the immobilization period may also lead to a higher rate of adverse events , suggesting that this treatment regimen needs to be applied judiciously . | Abstract The most common ankle injuries are ankle sprain and ankle fracture .
This review discusses treatments for ankle sprain ( including the management of the acute sprain and chronic instability ) and ankle fracture , using evidence from recent systematic review s and r and omized controlled trials . | STUDY DESIGN Prospect i ve inception cohort study of 62 consecutive patients seen in 2 orthopaedic clinics following ankle fracture . OBJECTIVES To investigate 4 putative predictors ( age , fracture classification , acute management [ surgical or nonsurgical ] , and ankle dorsiflexion range of motion measured at the time of cast removal ) of outcome after ankle fracture and to develop simple predictive models of outcome after ankle fracture . BACKGROUND Ankle fracture is a common condition . However , few studies have investigated factors that predict outcome after ankle fracture . METHODS AND MEASURES Sixty-two consecutive subjects aged 17 or older with ankle fractures were recruited from 2 hospital orthopaedic clinics . Outcome measures recorded at 6 weeks and 6 months after cast removal included 2 functional question naires , patients ' ratings of global improvement , and a measure of ankle dorsiflexion . The predictive value of 4 variables selected a priori was analyzed using bivariate and stepwise multiple linear regression . RESULTS Ankle dorsiflexion and fracture classification predicted outcome 6 weeks and 6 months after cast removal for all outcome measures used ( P < .05 , r2 = 0.09 - 0.47 ) . Fracture management ( surgical or nonsurgical ) inconsistently predicted outcome at both 6 weeks and 6 months , and age did not predict outcome at either 6 weeks or 6 months after cast removal . The predictive models explain between 19 % and 58 % of the variance in outcomes 6 weeks after cast removal and 19 % to 52 % of the variance in outcomes 6 months after cast removal . CONCLUSION Ankle dorsiflexion measured at the time of cast removal and fracture classification are clinical ly significant predictors of outcome after ankle fracture ; however , much unexplained variation in outcomes still exists In a prospect i ve study of 321 consecutive cases of dislocation ankle fractures , operatively treated according to the AO ( ASIF ) principles , 306 cases ( 95 % ) were followed up two to six years after surgery . The infection rate was 1.8 % with no septic arthritis . The clinical results were " excellent and good " in 82 % , " acceptable " in 8 % , and " poor " in 10 % . Posttraumatic arthritis occurred in 14 % and was significantly more common among middle-aged women . There was a strong correlation between the degree of arthritis and the clinical result . A computer analysis ( AID ) revealed that the most decisive factors influencing the clinical result were the type of fracture , the accuracy of the reduction , and the sex of the patient . Exact reduction , rigid internal fixation , early postoperative joint exercises , and subsequent full weight-bearing in a below-the-knee walking plaster are essential for a good end result of fracture-dislocations of the ankle joint BACKGROUND AND PURPOSE Passive joint mobilization is commonly used by physical therapists as an intervention for acute ankle inversion sprains . A r and omized controlled trial with blinded assessors was conducted to investigate the effect of a specific joint mobilization , the anteroposterior glide on the talus , on increasing pain-free dorsiflexion and 3 gait variables : stride speed ( gait speed ) , step length , and single support time . SUBJECTS Forty-one subjects with acute ankle inversion sprains ( < 72 hours ) and no other injury to the lower limb entered the trial . METHODS Subjects were r and omly assigned to 1 of 2 treatment groups . The control group received a protocol of rest , ice , compression , and elevation ( RICE ) . The experimental group received the anteroposterior mobilization , using a force that avoided incurring any increase in pain , in addition to the RICE protocol . Subjects in both groups were treated every second day for a maximum of 2 weeks or until the discharge criteria were met , and all subjects were given a home program of continued RICE application . Outcomes were measured before and after each treatment . RESULTS The results showed that the experimental group required fewer treatment sessions than the control group to achieve full pain-free dorsiflexion . The experimental group had greater improvement in range of movement before and after each of the first 3 treatment sessions . The experimental group also had greater increases in stride speed during the first and third treatment sessions . DISCUSSION AND CONCLUSION Addition of a talocrural mobilization to the RICE protocol in the management of ankle inversion injuries necessitated fewer treatments to achieve pain-free dorsiflexion and to improve stride speed more than RICE alone . Improvement in step length symmetry and single support time was similar in both groups OBJECTIVE To test the efficacy of low-level laser therapy on lateral ankle sprains as an addition to a st and ardized treatment regimen , a trial was conducted in which high-dose laser ( 5J/cm2 ) , low-dose laser ( 0.5J/cm2 ) , and placebo laser therapy ( 0J/cm2 ) at skin level were compared . DESIGN R and omized , double-blind , controlled clinical trial with a follow-up of 1 year . Patients , therapists , assessors , and analysts were blinded to the assigned treatment . SETTING An ambulatory care setting . PATIENTS After informed consent and verification of exclusion criteria , 217 patients with acute lateral ankle sprains were r and omized to three groups from September 1 , 1993 , through December 31 , 1995 . INTERVENTIONS Twelve treatments of 904 nm laser therapy in 4 weeks as an adjunct to a st and ardized treatment regimen of 4 weeks of brace therapy combined with st and ardized home exercises and advice . The laser therapy device used was a 904 nm Ga-As laser , with 25-watt peak power and 5,000 or 500Hz frequency , a pulse duration of 200nsec , and an irradiated area of 1cm2 . PRIMARY OUTCOME MEASURES Pain and function as reported by the patient . RESULTS Intention-to-treat analysis of the short-term results showed no statistically significant difference on the primary outcome measure , pain ( p = .41 ) , although the placebo group showed slightly less pain . Function was significantly better in the placebo group at 10 days ( p = .01 ) and 14 days ( p = .03 ) after r and omization . The placebo group also performed significantly better on days of sick leave ( p = .02 ) and at some points for hindrance in activities in daily life and pressure pain , as well as subjective recovery ( p = .05 ) . Intention-to-treat analysis showed that total days of absenteeism from work and sports were remarkably lower in the placebo group than in the laser groups , ranging from 3.7 to 5.3 and 6 to 8 days , respectively . The total number of relapses at 1 year in the low-dose laser group ( n = 22 ) was significantly higher ( p = .04 ) than in the other two groups ( high laser , n = 13 ; placebo , n = 13 ) . Subgroup analysis to correct for possible confounders did not alter these findings . CONCLUSIONS Neither high- nor low-dose laser therapy is effective in the treatment of lateral ankle sprains BACKGROUND During the recovery period after acute ankle sprain , it is unclear whether conventional treatment should be supported by supervised exercise . AIM To evaluate the short- and long-term effectiveness of conventional treatment combined with supervised exercises compared with conventional treatment alone in patients with an acute ankle sprain . DESIGN R and omised controlled clinical trial . SETTING A total of 32 Dutch general practice s and the hospital emergency department . METHOD Adults with an acute lateral ankle sprain consulting general practice s or the hospital emergency department were allocated to either conventional treatment combined with supervised exercises or conventional treatment alone . Primary outcomes were subjective recovery ( 0 - 10 point scale ) and the occurrence of a resprain . Measurements were carried out at intake , 4 weeks , 8 weeks , 3 months , and 1 year after injury . Data were analysed using intention-to-treat analyses . RESULTS A total of 102 patients were enrolled and r and omised to either conventional treatment alone or conventional treatment combined with supervised exercise . There was no significant difference between treatment groups concerning subjective recovery or occurrence of resprains after 3 months and 1-year of follow-up . CONCLUSION Conventional treatment combined with supervised exercises compared to conventional treatment alone during the first year after an acute lateral ankle sprain does not lead to differences in the occurrence of resprains or in subjective recovery The sport and leisure industry is one of the fastest growing sectors of the business market . It has been estimated that each year 1–1.5 million people attend accident and emergency ( A&E ) departments in Britain,1 and 3.7 million people present to emergency departments in the USA,2 with an injury related to sport and exercise . With these levels of presentation A&E departments can provide valuable research into the demographics of sports related injuries . There are numerous studies regarding the incidence of sports injuries within a community or defined population , however , there is little modern research investigating specifically the nature of sports injuries presenting to an A&E department in Britain.3–6 Other studies have been published from Irel and , 7,8 Europe,9–11 Australasia,12,13 Asia,14 and more recently North America.2,15 This observational study aim ed to determine the incidence of attendance , types of injuries , nature of the sport involved , and the arrangements for follow up management in patients presenting , with an injury related to sport , to the A&E department of Crosshouse Hospital , Kilmarnock . The study took place prospect ively over a period of three months from February to April 1999 and included people 16 years of age or over . Any patient presenting with an injury attributable to participation in organised sport or recreational activity had their details and A&E number noted by the triage nurse on duty . Only new attendances were included . Relevant A&E cards Background : Lateral ligament ankle sprains are the single most common sports injury . Objective : To determine the functional outcome of the ankle joint after a moderate or severe inversion injury , comparing st and ard treatment with an elastic support b and age against an Aircast ankle brace . Design : Prospect i ve , r and omised controlled trial . Setting : Two accident and emergency departments . Method : Fifty patients presenting consecutively were r and omised into two equal groups : one group was treated with an elastic support b and age and the other with an Aircast ankle brace . All patients were given a st and ardised advice sheet referring to rest , ice , compression , and elevation . Patients were review ed after 48–72 hours , 10 days , and one month . Primary outcome measure : Ankle joint function assessed at 10 days and one month using the modified Karlsson scoring method ( maximum score 90 ) . Secondary outcome measure : The difference in ankle girth ( swelling ) and pain score at 10 days . Results : Seventeen patients in the elastic support b and age group ( six defaulted , two excluded ) and 18 patients in the Aircast ankle brace group ( six defaulted , one excluded ) completed the study . There were no significant differences between the two groups at presentation in terms of age ( mean 35.3 and 32.6 years respectively ) , sex , dominant leg , left or right ankle injured , previous injury , time to presentation ( median three and four hours respectively ) , difference in ankle girth ( mean 14.5 and 14.3 mm respectively ) , and pain scores ( mean 6.2 and 5.8 respectively ) . The Karlsson score was significantly higher in the Aircast ankle cast group than in the elastic b and age group at 10 days ( mean 50 v 35 , p = 0.028 , 95 % confidence interval ( CI ) 1.7 to 27.7 ) and one month ( mean 68 v 55 , p = 0.029 , 95 % CI 1.4 to 24.8 ) ( Student ’s t test ) . There was no difference between the groups in the secondary outcome measures ( swelling , p = 0.09 ; pain , p = 0.07 ) . When hierarchical multiple regression analysis was used to correct for possible baseline confounding factors , the Aircast ankle brace group was significantly associated with higher Karlsson scores at 10 days ( p = 0.009 ) and one month ( p = 0.024 ) . Conclusion : The use of an Aircast ankle brace for the treatment of lateral ligament ankle sprains produces a significant improvement in ankle joint function at both 10 days and one month compared with st and ard management with an elastic support b and age OBJECTIVE The primary aim of this study was to determine the effectiveness and cost-effectiveness of adding manual therapy to a physiotherapy programme for ankle fracture . DESIGN Assessor-blinded r and omized controlled trial . PARTICIPANTS Ninety-four adults were recruited within one week of cast removal for isolated ankle fracture . Inclusion criteria were : they were able to weight-bear as tolerated or partial weight-bear , were referred for physiotherapy , and experienced pain . Ninety-one participants completed the study . METHODS Participants were r and omly allocated to receive manual therapy ( anterior-posterior joint mobilization over the talus ) plus a st and ard physiotherapy programme ( experimental ) , or the st and ard physiotherapy programme only ( control ) . They were assessed by a blinded assessor at baseline , and at 4 , 12 and 24 weeks . The main outcomes were activity limitation and quality of life . Information on costs and healthcare utilization was collected every 4 weeks up to 24 weeks . RESULTS There were no clinical ly worthwhile differences in activity limitation or quality of life between groups at any time-point . There was also no between-group difference in quality -adjusted life-years , but the experimental group incurred higher out-of-pocket costs ( mean between-group difference = AU$200 , 95 % confidence interval 26 - 432 ) . CONCLUSION When provided in addition to a physiotherapy programme , manual therapy did not enhance outcome in adults after ankle fracture Objective : To identify intrinsic predictors of lateral ankle sprain . Design : Prospect i ve cohort study . Setting : A performing arts secondary school and a dance school . Participants : One hundred fifteen adolescent dancers ( 94 female and 21 male ) entered the study . One ankle of each dancer was r and omly assigned to a test group ( n = 114 ) , and the other was assigned to a validation group ( n = 112 ) . Predictors : Eighteen measures , including age , dance history , previous ankle sprain , ankle and foot laxity and range of motion , and balance from test ankles were entered into a backwards stepwise Cox regression model . The model generated with the test group was used to predict ankle sprains in the validation group . Main Outcome Measure : Time to first lateral ankle sprain . Results : An increased risk of sprain in the test group was predicted by younger age [ hazard ratio ( HR ) = 0.65 , 95 % CI 0.45 - 0.94 ] , previous sprain of the contralateral ankle ( HR = 3.76 , CI 1.24 - 11.40 ) , increased passive inversion range ( HR = 1.06 , CI 1.00 - 1.12 ) , and inability to balance on demipointe ( HR = 3.75 , CI 1.02 - 13.73 ) . Of these predictors , only previous sprain of the contralateral ankle significantly predicted ankle sprain in the validation group ( HR = 3.90 , CI 1.49 - 10.22 ) . The predictive accuracy of this variable was not strong ( positive likelihood ratio of 2.01 and negative likelihood ratio of 0.45 ) . Conclusion : A history of previous lateral ankle sprain is associated with an increase in the risk of future sprain of the contralateral ankle BACKGROUND Ankle fractures are among the most common injuries treated by orthopaedic surgeons . However , very few investigators have examined the functional recovery following ankle fracture surgery and , to our knowledge , none have analyzed factors that may predict functional recovery . In this study , we evaluated predictors of short-term functional outcome following surgical stabilization of ankle fractures . METHODS Over three years , 232 patients who sustained a fracture of the ankle and were treated surgically were followed prospect ively , for a minimum of one year . Trained interviewers recorded baseline characteristics , including patient demographics , medical comorbidities , and functional status according to the Short Musculoskeletal Function Assessment ( SMFA ) . Laboratory findings , the American Society of Anesthesiologists ( ASA ) class , and operative findings were recorded from the chart during hospitalization . Follow-up information included the occurrence of complications or additional surgery , weight-bearing status , functional status according to the SMFA , and the American Orthopaedic Foot and Ankle Society ( AOFAS ) ankle-hindfoot score . The data were analyzed to determine predictors of functional recovery at three months , six months , and one year postoperatively . RESULTS Complete follow-up data were available for 198 patients ( 85 % ) . At one year , 174 ( 88 % ) of the patients had either no or mild ankle pain and 178 ( 90 % ) had either no limitations or limitations only in recreational activities . According to the AOFAS ankle-hindfoot score , 178 ( 90 % ) of the patients had > or = 90 % functional recovery . A patient age of less than forty years was a predictor of recovery , as measured with the SMFA subscores , at six months after the ankle fracture . At one year , however , age was no longer a predictor of recovery . Patients who were younger than forty were more likely to recover > or = 90 % of function ( p = 0.004 ) , and men were more likely than women to recover function ( p = 0.02 ) . ASA Class 1 or 2 ( p = 0.03 ) and an absence of diabetes ( p = 0.02 ) were also predictors of better functional recovery at one year . SMFA subscores were below average at baseline , indicating a healthy population . At three and six months postoperatively , all SMFA subscores were significantly higher than the baseline subscores ( p < 0.001 ) ; however , at one year , the SMFA subscores were almost back to the baseline , normal level . CONCLUSIONS One year after ankle fracture surgery , patients are generally doing well , with most experiencing little or mild pain and few restrictions in functional activities . They have a significant improvement in function compared with six months after the surgery . Younger age , male sex , absence of diabetes , and a lower ASA class are predictive of functional recovery at one year following ankle fracture surgery . It is important to counsel patients and their families regarding the expected functional recovery after an ankle injury STUDY OBJECTIVE The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment ( OMT ) as administered in the emergency department ( ED ) for the treatment of patients with acute ankle injuries . METHODS Patients aged 18 years and older with unilateral ankle sprains were r and omly assigned either to an OMT study group or a control group . Independent outcome variables included edema , range of motion ( ROM ) , and pain . Both groups received the current st and ard of care for ankle sprains and were instructed to return for a follow-up examination . Patients in the OMT study group also received one session of OMT from an osteopathic physician . RESULTS Patients in the OMT study group had a statistically significant ( F = 5.92 , P = .02 ) improvement in edema and pain and a trend toward increased ROM immediately following intervention with OMT . Although at follow-up both study groups demonstrated significant improvement , patients in the OMT study group had a statistically significant improvement in ROM when compared with patients in the control group . CONCLUSIONS Data clearly demonstrate that a single session of OMT in the ED can have a significant effect in the management of acute ankle injuries STUDY DESIGN Prospect i ve , r and omized controlled trial . OBJECTIVE To examine the effects of a 4-week rehabilitation program for chronic ankle instability ( CAI ) on postural control and lower extremity function . BACKGROUND CAI is associated with residual symptoms , performance deficits , and reinjury . Managing CAI is challenging and more evidence is needed to guide effective treatment . METHODS AND MEASURES Subjects with unilateral CAI were r and omly assigned to the rehabilitation ( CAI-rehab , n=16 ) or control ( CAI-control , n=13 ) group . Subjects without CAI were assigned to a healthy group ( n=19 ) . Baseline testing included the ( 1 ) center of pressure velocity ( COPV ) , ( 2 ) star excursion balance test ( SEBT ) , and ( 3 ) Foot and Ankle Disability index ( FADI ) and FADI-Sports Subscale ( FADI-Sport ) . The CAI-rehab group completed 4 weeks of rehabilitation that addressed range of motion , strength , neuromuscular control , and functional tasks . After 4 weeks , all subjects were retested . Nonparametric analyses for group differences and between-group comparisons were performed . RESULTS Subjects with CAI demonstrated deficits in postural control and SEBT reach tasks of the involved limb compared to the uninvolved limb and reported functional deficits of the involved limb compared to healthy subjects . Following rehabilitation , the CAI-rehab group had greater SEBT reach improvements on the involved limb than the other groups and greater improvements in FADi and FADI-Sport scores . CONCLUSIONS These results demonstrate postural control and functional limitations exist in individuals with CAl . In addition , rehabilitation appears to improve these functional limitations . Finally , there is evidence to suggest the SEBT may be a good functional measure to monitor change after rehabilitation for CAI In a prospect i ve , r and omised study , 27 patients with internally fixed ankle fractures were treated post-operatively for a period of six weeks by application of either a new dynamic vacuum orthosis with permitted mobilisation to 10 ° –0 ° –10 ° at the ankle joint or a synthetic cast . Full weight bearing was allowed in both groups after two weeks . The cast group was prescribed four weeks of physiotherapy following six weeks of immobilisation . After ten weeks , the Olerud and Mol and er score showed a significant difference in favour of the orthosis . Early functional outcomes were significantly better for this group after six weeks and ten weeks . Patients in the orthosis group who were in formal employment returned to work 24 days earlier than those in the control group . Treatment of the orthosis patients took up three to four times less working time for the medical personnel . A saving of 38 euros on directly ascertainable costs could be evaluated . Rehabilitation of ankle fractures with a dynamic vacuum orthosis leads to better early functional results and greater patient satisfaction . The orthosis fulfils the conditions for early return to work . Treatment with an orthosis not only reduces working time for medical personnel but economises on expenditure for treatment and rehabilitation . RésuméUne étude r and omisée a été réalisée chez 27 patients présentant une fracture de la cheville et traités sur une période de six semaines soit par une orthèse dynamique permettant une mobilisation de 10 ° dans chaque secteur soit par une immobilisation plâtrée . Une marche avec appui complet a été autorisée dans les deux groupes , après 15 jours . Le groupe des patients plâtrés a bénéficié de 4 semaines de rééducation après six semaines d’immobilisation . Après 10 semaines , le score d’Olerud et de Mol and er montre une différence significative dans les résultats en faveur de l’orthèse . En effet , le devenir fonctionnel de ces patients a été de façon significative bien meilleur pour ce groupe après six semaines et après dix semaines . Ces patients sont retournés au travail 24 jours plus tôt que dans le groupe contrôle . Le traitement par orthèse permet d’économiser 38 euros et du temps médical . La rééducation de la fracture des chevilles grâce à l’orthèse dynamique permet un résultat fonctionnel excellent et relativement rapide . Cette orthèse met les patients dans de bonnes conditions pour un retour précoce à l’emploi , ce traitement permet également d’économiser le travail des médecins et permet également de faire des économies sur le temps de rééducation In an unselected prospect ively planned series of 611 ankle fractures 25 % were of the AO ( Weber ) type A , 56 % type B and 13 % type C ; 4 % were impact fractures . The fractures were also classified according to Lauge Hansen 's system , which was considered more complicated and not suitable for planning of operative treatment . Lauge Hansen 's theory of the mechanism of the supination-eversion ( SE ) injury is question ed -- outward rotation does not seem to be obligatory for the typical SE injury . 345 fractures were operated on , and 327 ( 95 % ) of them were followed up 1 - 6 years after operation . The range of motion was measured as loaded dorsal extension ( normal value 33 degrees ) and loaded plantar flexion ( normal value 45 degrees ) . The clinical results were " excellent " to " good " for 81 % of the dislocation fractures , 38 % of the impact fractures and for two of the six combined shaft/ankle fractures . In 14 % of the dislocation fractures and 50 % of the impact fractures posttraumatic arthritis developed . There was a significantly higher degree of arthritis among the patients with a posterior articular surface bearing fragment . There was also a strong correlation between the degree of arthritis and poor clinical results . The clinical and radiographic results from use of the AO ( ASIF ) method were better than those of conservative treatment or other operative methods . According to an AID analysis the most important factors for the final outcome were : 1 ) type of fracture , 2 ) accuracy of operative reduction and 3 ) the patient 's sex Ninety-two intra-articular ankle fractures were r and omly selected for either open reduction and internal fixation or closed reduction and plaster cast . The patients were followed for an average of seven years . The initial course was more favorable in surgically reduced fractures . However , follow-up examinations showed little difference in results between the two forms of treatment QUESTIONS Do patients with a severe ankle injury ( baseline ankle function score < or = 40 ) do worse in the short-term than patients with a mild injury ( score > 40 ) ? Does physiotherapy intervention have more effect on patients with a severe injury compared with a mild injury in the short- or long-term ? Is self-reported recovery related to ankle function score over time ? DESIGN Subgroup analysis of a r and omised trial . PARTICIPANTS 102 adults with an acute lateral ankle sprain . INTERVENTION The experimental group received physiotherapist-supervised exercises in addition to conventional intervention . OUTCOME MEASURES Outcomes were self-reported recovery , pain , and instability all measured on a 10-point visual analogue scale , and incidence of re-sprain . Measurements were collected at baseline , 4 and 8 weeks , 3 and 12 months . RESULTS Participants with a severe injury did worse in 3 out of 7 outcomes than those with a mild injury at 4 weeks but not at 8 weeks . There was no difference in effect of physiotherapy intervention in those with a severe injury compared with a mild injury , at 8 weeks or 12 months . However , there was an effect of physiotherapy intervention in those with a severe injury in 3 out of 7 outcomes at 8 weeks . Self-reported recovery was related to ankle function score at all points in time ( r = 0.48 to 0.79 ) . CONCLUSION The results of this study only partially support the recommendations regarding the use of the ankle function score in the ' Acute Ankle Injury ' guideline of the Royal Dutch Society of Physiotherapists OBJECTIVE To compare the efficacy of short- and long- duration passive stretches with a control treatment for the management of plantarflexion contracture after cast immobilization for ankle fracture . DESIGN Assessor-blinded , r and omized controlled trial . SETTING Hospital physical therapy outpatient departments . PARTICIPANTS Adults with plantarflexion contracture ( N=150 ) after cast immobilization for ankle fracture . All subjects were weight bearing or partial weight bearing . INTERVENTIONS Exercise only , exercise plus short- duration passive stretch , and exercise plus long- duration passive stretch . All subjects had a 4-week course of exercises . In addition , subjects in the short- duration stretch plus exercise group completed 6 minutes of stretching per day , and subjects in the long- duration stretch plus exercise group completed 30 minutes of stretching per day . MAIN OUTCOME MEASURES Lower Extremity Functional Scale and passive dorsiflexion range of motion with the knee bent and straight at baseline , and at 4 weeks and 3 months postintervention . RESULTS One hundred thirty-nine ( 93 % ) subjects completed the 4-week assessment and 134 ( 89 % ) subjects completed the 3-month assessment . There were no statistically significant or clinical ly important between-group differences for the primary outcomes . CONCLUSIONS The addition of passive stretching confers no benefit over exercise alone for the treatment of plantarflexion contracture after cast immobilization for ankle fracture OBJECTIVE The purpose of this study was to determine the efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains . DESIGN A single-blind , comparative , controlled pilot study . SETTING Technikon Natal Chiropractic Day Clinic . PARTICIPANTS Thirty patients with subacute and chronic grade I and grade II ankle inversion sprains . Patients were recruited from the public ; they responded to advertisements placed in newspapers and on notice boards around the campus and local sports clubs . INTERVENTION Each of the 15 patients in the treatment group received the ankle mortise separation adjustment . Each of the 15 patients in the placebo group received 5 minutes of detuned ultrasound treatment . Each participant received a maximum of 8 treatment sessions spread over a period of 4 weeks . MAIN OUTCOME MEASURE Patients were evaluated at the first treatment , at the final treatment , and at a 1-month follow-up consultation . Subjective scores were obtained by means of the short-form McGill Pain Question naire and the Numerical Pain Rating Scale 101 . Objective measurements were obtained from goniometer readings measuring ankle dorsiflexion range of motion and algometer readings measuring pain threshold over the ankle lateral ligaments . A functional evaluation of ankle function was also used . RESULTS Although both groups showed improvement , statistically significant differences in favor of the adjustment group were noted with respect to reduction in pain , increased ankle range of motion , and ankle function . CONCLUSIONS This study appears to indicate that the mortise separation adjustment may be superior to detuned ultrasound therapy in the management of subacute and chronic grade I and grade II inversion ankle sprains Objective To evaluate the effectiveness of an unsupervised proprioceptive training programme on recurrences of ankle sprain after usual care in athletes who had sustained an acute sports related injury to the lateral ankle ligament . Design R and omised controlled trial , with one year follow-up . Setting Primary care . Participants 522 athletes , aged 12 - 70 , who had sustained a lateral ankle sprain up to two months before inclusion ; 256 ( 120 female and 136 male ) in the intervention group ; 266 ( 128 female and 138 male ) in the control group . Intervention Both groups received treatment according to usual care . Athletes allocated to the intervention group additionally received an eight week home based proprioceptive training programme . Main outcome measure Self reported recurrence of ankle sprain . Results During the one year follow-up , 145 athletes reported a recurrent ankle sprain : 56 ( 22 % ) in the intervention group and 89 ( 33 % ) in the control group . Nine athletes needed to be treated to prevent one recurrence ( number needed to treat ) . The intervention programme was associated with a 35 % reduction in risk of recurrence . Cox regression analysis showed significantly fewer recurrent ankle sprains in the intervention than in the control group . This effect was found for self reported recurrent ankle sprains ( relative risk 0.63 , 95 % confidence interval 0.45 to 0.88 ) , recurrent ankle sprains leading to loss of sports time ( 0.53 , 0.32 to 0.88 ) , and recurrent ankle sprains result ing in healthcare costs or lost productivity costs ( 0.25 , 0.12 to 0.50 ) . No significant differences were found between medically treated athletes in the intervention group and medically treated controls . Athletes in the intervention group who were not medically treated had a significantly lower risk of recurrence than controls who were not medically treated . Conclusions The use of a proprioceptive training programme after usual care of an ankle sprain is effective for the prevention of self reported recurrences . This proprioceptive training was specifically beneficial in athletes whose original sprain was not medically treated . Trial registration Physiotherapists frequently use manipulative therapy techniques to treat dysfunction and pain result ing from ankle sprain . This study investigated whether a Mulligan 's mobilization with movement ( MWM ) technique improves talocrural dorsiflexion , a major impairment following ankle sprain , and relieves pain in subacute population s. Fourteen subjects with subacute grade II lateral ankle sprains served as their own control in a repeated measures , double-blind r and omized controlled trial that measured the initial effects of the MWM treatment on weight bearing dorsiflexion and pressure and thermal pain threshold . The subacute ankle sprain group studied displayed deficits in dorsiflexion and local pressure pain threshold in the symptomatic ankle . Significant improvements in dorsiflexion occurred initially post-MWM ( F(2,26 ) = 7.82 , P = 0.002 ) , but no significant changes in pressure or thermal pain threshold were observed after the treatment condition . Results indicate that the MWM treatment for ankle dorsiflexion has a mechanical rather than hypoalgesic effect in subacute ankle sprains . The mechanism by which this occurs requires investigation if we are to better underst and the role of manipulative therapy in ankle sprain management One hundred and thirty-eight patients with a closed grade -4 supination-external rotation or pronation-external rotation ankle fracture ( Lauge-Hansen classification ) who were seen in the emergency room of the University of Chicago Hospitals were entered into a r and omized study of the results of various methods of treatment . Ninety-six patients with satisfactory initial closed reduction were r and omized between continued closed treatment in a plaster cast and open reduction with rigid internal fixation according to the techniques of the Association for the Study of Internal Fixation ( ASIF ) . Forty-two patients with unsatisfactory closed reduction were r and omized between open reduction with internal fixation of only the medial malleolus and open reduction with rigid internal fixation according to the ASIF techniques . Of the 138 patients who were admitted to the study , only seventy-one ( 51 per cent ) could be followed for an average of 3.5 years ( a typical return rate of urban trauma centers ) . The outcomes were evaluated by a scoring system that included clinical , anatomical , and arthritis scores . Statistical analysis of the data showed that , of the patients with initial satisfactory closed reduction , the ones treated by open reduction and rigid internal fixation had significantly higher total scores , particularly the patients who were more than fifty years old and those with a medial malleolar fracture . The small number of patients with unsatisfactory closed reduction who were treated by one of the two types of open reduction and internal fixation and were available for follow-up precluded drawing any conclusions about the superiority of one method of internal fixation over the other in that group . The difference in the talocrural angle between the injured and normal sides was the only statistically significant radiographic indicator of a good prognosis We studied the epidemiology of ankle fractures prospect ively during 1 year in a population of about 200,000 . The overall incidence rate was 107 fractures per 10(5 ) person-years . Below the age of 50 , ankle fractures were commonest in men . After this age , females became predominant and the age-specific incidence rates decreased in both sexes . The main cause of fracture was falls ( 87 % ) , on the ground , on stairs or from a height . 137 fractures ( 55 % ) occurred in sports , play or other leisure activities . Most patients ( 64 % ) were walking , running or jumping at the time of injury . Alcohol and slippery surfaces were each involved in nearly a third of the cases . The distribution of the fractures according to both the Lauge-Hansen and the AO Weber classification systems were within the limits of previous series . Nearly half the patients were hospitalized and the fractures were operated on with osteo synthesis . Our findings indicate that ankle fractures are mainly caused by substantial trauma sustained during physical activity . Osteoporosis seems to be of minor importance PURPOSE The purpose of this r and omized controlled trial was to determine the effect of a 4-wk balance training program on static and dynamic postural control and self-reported functional outcomes in those with chronic ankle instability ( CAI ) . METHODS Thirty-one young adults with self-reported CAI were r and omly assigned to an intervention group ( six males and 10 females ) or a control group ( six males and nine females ) . The intervention consisted of a 4-wk supervised balance training program that emphasized dynamic stabilization in single-limb stance . Main outcome measures included the following : self-reported disability on the Foot and Ankle Disability Index ( FADI ) and the FADI Sport scales ; summary center of pressure ( COP ) excursion measures including area of a 95 % confidence ellipse , velocity , range , and SD ; time-to-boundary ( TTB ) measures of postural control in single-limb stance including the absolute minimum TTB , mean of TTB minima , and SD of TTB minima in the anteroposterior and mediolateral directions with eyes open and closed ; and reach distance in the anterior , posteromedial , and posterolateral directions of the Star Excursion Balance Test ( SEBT ) . RESULTS The balance training group had significant improvements in the FADI and the FADI Sport scores , in the magnitude and the variability of TTB measures with eyes closed , and in reach distances with the posteromedial and the posterolateral directions of the SEBT . Only one of the summary COP-based measures significantly changed after balance training . CONCLUSIONS Four weeks of balance training significantly improved self-reported function , static postural control as detected by TTB measures , and dynamic postural control as assessed with the SEBT . TTB measures were more sensitive at detecting improvements in static postural control compared with summary COP-based measures BACKGROUND Functional ankle instability is defined as the subjective sensation of giving way or feeling joint instability after repeated episodes of ankle sprain . The purpose of this study was to examine the effects of 12-week biomechanical ankle platform system training on static postural stability and ankle reposition sense in subjects with unilateral functional ankle instability . METHODS Twelve university students ( 4 females and 8 males ) with unilateral functional ankle instability volunteered as subjects . The active and passive reposition senses were assessed using an isokinetic dynamometer . The mean radius of the center of pressure excursion was recorded during single-leg st and ing with a force platform . A 12-week training program and a progression test for controlling the platform in certain directions and advancing to next training level was given to each subject . Repeated- measures 2-way analyses of variance were conducted to determine differences in postural stability and ankle proprioception between each limb before and after the training period . FINDINGS The mean radius of center of pressure on unilateral st and ing and the absolute error from pre-selected ankle angle in the functional ankle instability limb were significantly reduced after 12 weeks of training . INTERPRETATION These improvements in postural stability appear to reflect improved neuromuscular ability along with enhanced functional joint stability , as ankle proprioception also demonstrated the same positive improvements after training A series of 42 ankle fractures have been r and omised into two groups respectively undergoing either open reduction and internal fixation or manipulative reduction and plaster . Their progress after removal of all external splintage has been followed using simple gait analysis techniques . There appears to be no difference in the outcome of treatment of the two groups in the early recovery period ( up to 20 weeks ) STUDY DESIGN A double-blind r and omized crossover experimental study with repeated measures , including a no-treatment control condition . OBJECTIVE To evaluate the initial effect of 2 mobilization with movement ( MWM ) treatment techniques performed in weight bearing and non-weight bearing on posterior talar glide and talocrural dorsiflexion in individuals with recurrent lateral ankle sprain . BACKGROUND MWM treatment techniques are commonly used in the treatment of musculoskeletal pain , such as lateral ankle sprain . Recent evidence indicates that a lack of posterior talar glide and weight-bearing ankle dorsiflexion are common physical impairments in individuals with recurrent ankle sprains . MWM of the ankle joint involves the application of a combined posterior talar glide mobilization and active dorsiflexion movement . The recurrent ankle sprain injury and the MWM treatment techniques for the ankle seemingly provide an appropriate model to further evaluate the effects and mechanism(s ) of action of the MWM treatment techniques in a way that they have not been tested to date . METHODS Sixteen subjects ( mean + /- SD age , 19.8 + /- 2.3 years ) with a history of recurrent lateral ankle sprain and deficits in posterior talar glide ( 71 % ) and weight-bearing dorsiflexion ( 34 % ) were studied . A within-subjects study design was used to evaluate the effect of 2 independent variables : treatment conditions ( weight-bearing MWM , non-weight-bearing MWM , and a no-treatment control group ) and time ( pretreatment and posttreatment ) on the dependent variables of posterior talar glide and weight-bearing dorsiflexion . RESULTS Both the weight-bearing and non-weight-bearing MWM treatment techniques significantly improved posterior talar glide by 55 % and 50 % of the preapplication deficit between affected and unaffected sides , respectively , which was significantly greater than that of the control group ( P<.001 ) . The weight-bearing and non-weight-bearing MWM treatment techniques improved weight-bearing dorsiflexion by 26 % ( P<.017 ) , compared to 9 % for the control condition . The change in posterior talar glide , expressed as a proportion of pretreatment deficit , was correlated to the change in weight-bearing dorsiflexion ( r = .88 , P<.001 ) , but only after the weight-bearing MWM technique . CONCLUSION This preliminary study demonstrated an initial ameliorative effect of MWM treatment techniques on posterior talar glide and dorsiflexion range of motion in individuals with recurrent lateral ankle sprain . These results suggest that this technique should be considered in rehabilitation programs following lateral ankle sprain . This study provides justification for follow-up research of the long-term effects of MWM on lateral ankle sprain and proposes further work be conducted on the posterior talar glide test Forty-seven patients over the age of 55 years with a displaced fracture of the ankle were entered into a prospect i ve , r and omised study in order to compare open reduction and internal fixation with closed treatment in a plaster cast ; 36 were review ed after a mean of 27 months . The outcome was assessed clinical ly , radiologically and functionally using the Olerud score . The results showed that anatomical reduction was significantly less reliable ( p = 0.03 ) and loss of reduction significantly more common ( p = 0.001 ) in the group with closed treatment . Those managed by open reduction and internal fixation had a significantly higher functional outcome score ( p = 0.03 ) and a significantly better range of movement of the ankle ( p = 0.044 ) at review OBJECTIVE Low-level laser therapy ( LLLT ) has been used for the last few years to treat sports injuries . The purpose of this study was to compare three therapeutic protocol s in treating edema in second degree ankle sprains that did not require immobilization with a splint , under placebo-controlled conditions . MATERIAL S AND METHODS Forty-seven soccer players with second degree ankle sprains , selected at r and om , were divided into the following groups : The first group ( n = 16 ) was treated with the conventional initial treatment ( RICE , rest , ice , compression , elevation ) , the second group ( n = 16 ) was treated with the RICE method plus placebo laser , and the third group ( n = 15 ) was treated with the RICE method plus an 820-nm GaA1As diode laser with a radiant power output of 40 mW at 16 Hz . Before the treatment , and 24 , 48 , and 72 h later , the volume of the edema was measured . RESULTS A three by three repeated measures ANOVA with a follow up post hoc test revealed that the group treated with the RICE and an 820-nm GaA1As diode laser presented a statistically significant reduction in the volume of the edema after 24 h ( 40.3 + /- 2.4 mL , p < 0.01 ) , 48 h ( 56.4 + /- 3.1 mL , p < 0.002 ) , and 72 h ( 65.1 + /- 4.4 mL , p < 0.001 ) . CONCLUSIONS LLLT combined with RICE can reduce edema in second-degree ankle sprains |
1,386 | 20,407,343 | Fatal pulmonary embolism was rare .
CONCLUSION Venous thromboembolism is uncommon after elective spine surgery .
Trauma patients are at increased risk , and chemical prophylaxis should be considered . | OBJECTIVE To determine the high-risk population s for thromboembolic events in spine surgery patients , the risk of anticoagulation in spine surgery patients by type of anticoagulation , and whether there is a safe perioperative window of nonanticoagulation for these high-risk patients .
SUMMARY OF BACKGROUND DATA Thromboembolic complications after major spinal surgery is a significant risk for patients .
Anticoagulation to reduce this risk is of concern because of the possibility of excessive bleeding or postoperative hematomas and associated neurologic deficits .
There seems to be a paucity of literature on this topic . | Study Design . Thromboembolic disease ( TED ) after anterior/posterior spinal reconstructions was prospect ively evaluated in 66 consecutive patients . Objective . Determine the incidence of TED after anterior/posterior spinal reconstruction . Summary of Background Data . Few studies have examined the rate of TED after potentially high-risk combined anterior/posterior reconstructions . Magnetic resonance venography ( MRV ) is more effective at detecting pelvic deep venous thrombosis ( DVT ) than conventional screening , but has not been used in these patients . Methods . We undertook a prospect i ve cohort study of 66 consecutive adult patients ( mean , 52.7 ± 9.6 years ) undergoing combined anterior/posterior spinal reconstructions for spinal deformity . All patients received only mechanical DVT prophylaxis . After surgery , MRV and bilateral lower extremity Doppler ultrasounds were obtained to screen for DVT , and contrast-enhanced spiral computed tomography scans were obtained for clinical suspicion of pulmonary embolism ( PE ) . Results . The total incidence of postoperative TED was 13.6 % ( 9 patients ) . The overall rate of DVT was 9.1 % ( 6 patients ) , one-third occurring in the pelvis . PE developed in 7.6 % ( 5 patients ) . In 2 patients , PE developed less than 48 hours after positive dopplers . In 3 patients , PE developed despite negative screening studies . Right-sided thoracoabdominal approaches were associated with an increased risk of developing DVT ( P = 0.03 , Odds Ratio 9.8 ) , PE ( P = 0.01 , Odds Ratio 20 ) , and TED ( P = 0.004 , Odds Ratio 12 ) . Conclusion . We report a high rate of TED after extensive anterior/posterior spinal reconstructions , for which a right-sided thoracoabdominal approach is an independent risk factor and screening ineffective at preventing PE . These patients should be considered at high risk for postoperative TED In a prospect i ve , r and omized , double-blind investigation of anticoagulant agents for prevention of deep vein thrombosis in patients undergoing operations at the lumbar-vertebral disc , 179 patients were r and omly allocated to two groups . 87 patients received a fixed combination of low-molecular weight heparin 1,500 U-aPTT plus dihydroergotamine 0.5 mg ( LMWH/DHE ) once a day and additionally one injection of placebo per day , 92 patients received a fixed combination of sodium heparin 5,000 U plus dihydroergotamine 0.5 mg ( HDHE ) twice a day . Treatment was initiated two hours preoperatively in both groups and continued for at least seven days . Deep vein thrombosis ( DVT ) , detected by the 125Iodine-labelled fibrinogen uptake-test , occurred in four patients treated with LMWH/DHE and in three patients with HDHE . In all seven patients phlebography was performed , confirming the diagnosis of DVT in one patient of the LMWH/DHE group and in two patients of the HDHE group , only . No increased bleeding was found in either group . Especially no neurological complications caused by epidural bleeding were observed . We therefore recommended to treat routineously all patients undergoing operations at the vertebral disc with antithrombotic agents . The advantages of the once daily regimen with low-molecular weight heparin include better patients ' acceptance and less nursing time We performed a prospect i ve study of 317 patients in order to determine the prevalence of deep venous thrombosis after reconstructive operations on the spine ; 126 of the patients were examined with duplex ultrasound assessment s of the lower extremities to ensure that no asymptomatic thrombi were being missed . Thigh-high stockings and sequential pneumatic compression of the lower extremities were used , in all patients , for prophylaxis against venous thrombosis . No antiplatelet agents or anticoagulant medications were administered . There was no evidence of thrombosis on any of the duplex ultrasound studies . Subsequently , venous thrombosis developed and was treated successfully in one of the 126 tested patients and in one of the 191 untested patients , and a fatal pulmonary embolus developed in one of the untested patients . The over-all clinical prevalence of thrombotic complications was 0.9 per cent ( three complications in 317 patients ) . All three of the patients who had clinical evidence of thrombosis had had an anterior lumbar procedure because of a degenerative disorder or trauma ; however , we could not prove that this approach or these diagnoses were significant risk factors for thrombosis ( p < 0.05 ) . While it is possible that some thrombi may have escaped both clinical and ultrasonic detection , such thrombi apparently were not enough of a danger to warrant the use of intensive prophylactic procedures that are associated with more risk . On the basis of this prospect i ve study , therefore , we think that routine screening for the detection of asymptomatic thrombosis in patients who have had a procedure on the spine is unwarranted We prospect ively studied the incidence of deep vein thrombosis ( DVT ) of the thigh in 117 patients having posterior lumbar spinal fusion with instrumentation and bone grafting for degenerative disk disease or spondylolisthesis . Patients with neoplasm , infection , trauma , or history of DVT were excluded . Patients were r and omized into two groups . In the operating room , group 1 patients were placed in thigh-high antiembolic compression stockings ( TED hose ) , and group 2 patients were placed in antiembolic stockings and pneumatic compression stockings . In both groups , the stockings were used until discharge . Postoperatively , patients in both groups received 600 mg buffered aspirin twice daily . Comparative analysis of the two groups showed no difference in operative time , blood loss , number of levels of lumbar vertebrae fused , time to mobilization , weight , age , or sex . All patients had duplex scanning of the thigh postoperatively . No patient in the series was observed to have acute DVT by clinical examination or by ultrasonography Summary We have evaluated the incidence of bleeding complications using miniheparin(2 × 2500IU daily)-dihydroergotamine starting preoperatively in a r and omized , controlled , prospect i ve , double-blind study in 50 patients undergoing herniated lumbar disc operations . There was no difference in the incidence of intraoperative bleeding problems between the two groups . Preoperatively , 13 patients have been treated in another hospital with conventional low-dose heparin , and of these 13 patients , 7 developed bleeding complications . There were two deep wound hematomas in the placebo group . Early removal of stitches or operative revision of the wound was not necessary in either group . We conclude that the use of minidose heparin-dihydroergotamine is feasible for the prevention of thromboembolic complications in patients undergoing herniated lumbar disc operations , since an increased incidence of bleeding complications was not observed . This preventive method should therefore be further clinical ly evaluated Study Design . Intermittent pneumatic compression stockings ( IPC ) alone were prospect ively used to avoid deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) in 100 consecutive patients undergoing single-level anterior corpectomy/fusion ( ACF ) and in 100 patients having multilevel ACF/posterior fusion . Objectives . To determine the optimal prophylaxis against DVT and PE for patients undergoing anterior cervical spinal surgery . Background Data . Mini-heparin and low-dose heparin prophylaxis in neurosurgery poses a 2 % to 4 % risk of major postoperative hemorrhage with result ant neurologic sequelae . Methods . Prophylaxis consisted of IPC alone . Doppler studies of the lower extremities were routinely obtained 2 days after surgery . Single-level ACF ( 100 patients ) addressed two-level disc disease , spondylostenosis , and ossification of the posterior longitudinal ligament ( OPLL ) . One hundred patients undergoing multilevel ACF ( 3 + levels ) with posterior fusion ( C2–T1 ) exhibited OPLL/spondylostenosis . Results . One patient undergoing single-level ACF developed DVT/PE 6 days after surgery ; she exhibited Factor V Leiden mutation ( hypercoagulability syndrome ) . Although 7 patients undergoing circumferential surgery developed DVT 2 to 14 days following surgery ( mean , 7.15 days ) , only two clots localized in the iliac veins result ed in PEs ( days 10 and 14 after surgery ) . Conclusions . IPCs were as effective for prophylaxis against DVT/PE for 100 patients undergoing single-level ACF and for 100 having circumferential procedures as existing therapies ( mini-heparin and low-dose heparin ) , without the risk of hemorrhage . However , the 1 % and 2 % respective rates of PE were comparable to frequencies of PE encountered in other cranial/spinal series using mini-heparin and /or low-dose heparin regimens but avoided the 2 % to 4 % risk of major postoperative hemorrhage There is a need to improve postoperative analgesia to support the trend to shorter hospitalization after minimally invasive spine surgeries . Ketorolac Tromethamine has proven efficacy in decreasing postoperative pain but there is concern with postoperative epidural bleeding after spine procedures . We prospect ively assessed the incidence of bleeding complications after microdiscectomy in patients treated with a single 30 mg intraoperative dose of Ketorolac subsequent to wound closure . Group 1 consisted of 44 patients , 24 women and 20 men with mean age of 35.7 years ( 20 to 68 y ) treated with Ketorolac . Group 2 consisted of 45 patients , 28 men and 17 women with mean age 46.8 years ( 32 to 74 y ) , who underwent discectomy without Ketorolac . Postoperative bleeding complications were monitored along with pain levels and time to discharge . We detected no significant postoperative changes in coagulation parameters or bleeding from the surgical site in either group . Both group 1 and 2 had averaged preoperative visual analog scale scores for leg pain of 8 . Group 1 had an average postoperative visual analog scale score of 2.6 compared with 4 for group 2 two hours after surgery . Single dose intravenous Ketorolac provided beneficial analgesia without significant increase in risk of bleeding after microdiscectomy , enabling us to consistently perform microdiscectomy as an ambulatory procedure . Meticulous hemostasis should be accomplished before closure . Prolonged postoperative use is a promising alternative to narcotics STUDY DESIGN Adult spinal surgery patients were studied prospect ively to determine the incidence of sub clinical deep venous thrombosis . An overlapping group of patients was review ed retrospectively for symptomatic thromboembolism . OBJECTIVES To determine the incidence of symptomatic and asymptomatic thromboembolism in spinal surgery patients . SUMMARY OF BACKGROUND DATA Although thromboembolic complications are known to occur after spinal operations , there are limited published data on the incidence of pulmonary embolus or deep venous thrombosis after major spinal surgery . METHODS One hundred sixteen adult spinal surgery patients were examined with duplex ultrasound to determine the incidence of deep venous thrombosis . Seventy-three of these patients also underwent lung perfusion scans to look for sub clinical pulmonary embolism . A retrospective review was conducted of symptomatic thromboembolic complications occurring in a 2-year period at the authors ' center . Three hundred and eighteen major spinal reconstructive procedures were performed during the period review ed , which included the period of the prospect i ve study and therefore the patients of the prospect i ve group . Thigh-length compression stockings and pneumatic compression leggings were used for prophylaxis in all patients . RESULTS One patient had an asymptomatic iliac vein thrombosis , and seven patients had symptomatic pulmonary embolism ( 2.2 % ) . Six of the symptomatic pulmonary emboli occurred after combined anterior/posterior spinal fusions ( 6 % ) , whereas only one occurred after posterior decompression and fusion ( 0.5 % ) . CONCLUSIONS Duplex ultrasound appeared insensitive for diagnosing clots before embolization in this patient group . Simple mechanical prophylaxis for thromboembolism , which may be adequate for patients undergoing posterior procedures , may not be as protective for patients undergoing combined anterior/posterior spine surgery Study Design . A prospect i ve clinical study using venography to evaluate deep venous thrombosis after posterior spinal surgery . Objectives . To demonstrate the prevalence of deep venous thrombosis after posterior spinal surgery with no prophylaxis . Summary of Background Data . There have been few studies about the occurrence of deep venous thrombosis after spinal surgery in which venography was used for screening . Methods . Of the enrolled 134 patients undergoing posterior spinal surgery , 110 ( 82.1 % ) were examined with complete surveillance for deep venous thrombosis by venography . There were 64 males and 46 females . The average age at operation was 59.0 years ( range , 14–86 years ) . The levels of the operation were cervical in 54 , thoracic in 7 , and lumbar in 49 . All procedures were performed with patients under general anesthesia . Neither mechanical methods nor anticoagulation medications were used for prophylaxis against thromboembolism . Bilateral ascending venography was performed within 14 days after surgery . Results . There were no patients with clinical signs of deep venous thrombosis and pulmonary embolism . However , 17 patients ( 15.5 % ) showed venographic evidence of deep venous thrombosis , of whom 16 had distal thrombi , and only one had a proximal thrombus . Deep venous thrombosis was venographically evident in 3 ( 5.6 % ) of 54 patients who underwent cervical procedures , and it was evident in 13 ( 26.5 % ) of 49 patients who underwent lumbar procedures . This difference was statistical significant ( & khgr;2 test , P = 0.003 ) . Statistical comparison between patients who did and did not have deep venous thrombosis showed that age was statistically significant ( Mann – Whitney test;P < 0.05 ) . Conclusions . The prevalence of deep venous thrombosis after posterior spinal surgery is higher than generally recognized . Therefore , further study is necessary to clarify the appropriate method for screening and the effect of prophylaxis against thromboembolism after spinal surgery BACKGROUND Patients who undergo neurosurgical procedures are at high risk for perioperative deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ) , which have been reported in 6 % to 43 % of these patients . OBJECTIVES To ( 1 ) determine the utility of prospect i ve DVT surveillance in patients who undergo neurosurgical procedures by using venous duplex ultrasound scanning ( VDUS ) , ( 2 ) assess the efficacy of DVT prophylaxis ( elastic stockings and intermittent pneumatic compression ) , ( 3 ) identify subgroups of patients who are at higher risk , and ( 4 ) determine whether DVT surveillance would reduce the incidence of fatal PE . DESIGN All patients had undergone preoperative VDUS of both lower extremities , and postoperative VDUS was performed on days 3 and 7 , and weekly thereafter until patients were ambulatory or discharged . PATIENTS During a 5-year period , 2643 patients who underwent neurosurgical procedures were enrolled in prospect i ve DVT surveillance . SETTING University-affiliated community hospital . RESULTS Acute DVT was diagnosed in 147 ( 5.6 % ) of the 2643 patients . Eighty-one percent of the patients with acute DVT were asymptomatic at the time of diagnosis . Deep vein thrombosis developed de novo in the proximal veins in 98 % of the patients . Patients in whom a craniotomy was done had a significantly higher risk for DVT ( 7.7 % , P = .006 ) , and patients who underwent cervical or lumbar spinal surgical procedures had a significantly lower risk ( 1.5 % , P < .001 ) . Among those patients in whom a craniotomy was performed for treatment of a tumor and who had DVT , 87 % had malignant neoplasms . Significant lower-extremity neuromotor dysfunction was present in 69 % of all patients with DVT , and this finding predominated among patients with DVT in the subgroups with a lower risk . A PE was diagnosed in 5 patients ( 0.19 % ) while they were hospitalized , and a PE was fatal in 2 ( 0.07 % of all patients ) . CONCLUSIONS Most perioperative DVTs were clinical ly silent and formed spontaneously in proximal venous segments where there would be a risk for a PE . The overall incidence of DVT ( 5.6 % ) was low , suggesting effective DVT prophylaxis . Patients who underwent spinal surgical procedures were at a significantly lower risk for DVT , and future surveillance is not indicated in this patient group unless other conditions exist ( paralysis , malignancy ) . Patients in whom a craniotomy was performed had a significantly higher risk of DVT , particularly when other risk factors existed . The low incidence of a fatal PE ( 0.07 % ) reflected that early detection and treatment of proximal DVT were facilitated by prospect i ve VDUS surveillance in these patients We studied the difference in postoperative thrombotic complications after major spinal surgery between two commonly used external compression devices . Our 136 subjects were prospect ively r and omized to receive either thigh-high sequential pneumatic compression wraps or pneumatic foot-compression wraps . All were studied postoperatively with duplex ultrasonography and analyzed for leg swelling , the rate of thrombotic events , and overall subjective patient comfort . The rate of postoperative thrombosis was 1.5 % . The one pulmonary embolism was successfully treated with heparin . One other patient had a small asymptomatic thrombus of the saphenous vein . Both subjects wore foot wraps . Subjectively , the devices were rated as being equally comfortable . We believe that external compression for thrombosis prophylaxis after major spinal surgery is effective . The particular device chosen may be driven by other factors such as cost , physician or nursing preference , and ease of application Few data are available to evaluate approach-related differences in perioperative complications with lumbar interbody fusion devices . Complications occurring in the intraoperative and immediate postoperative period were identified and categorized for 31 consecutive posterior lumbar interbody fusions ( PLIFs ) and 88 consecutive anterior lumbar interbody fusions ( ALIFs ) . In this study , all lumbar interbody fusions were conducted with threaded cylindrical devices as st and -alone internal fixation devices . Multivariate analysis was used to account for potential covariates and identify factors associated with an increased complication risk . Twenty-two percent of the patients had a perioperative complication . The relative risk of having a perioperative complication was 4.75 times higher for the PLIF group . All intraoperative complications occurred in the PLIF group . The relative risk of having a major postoperative complication was 6.8 times higher in the PLIF group than the ALIF group . Anterior approached patients tended to have visceral ( ileus , 6 % ) and vascular ( deep venous thrombosis , 2 % ) complications . In the posterior group , complications were neurologic and dura related ( pseudomeningocele , 16 % ; epidural hematoma , 3 % ) and occurred most frequently in patients that had had previous posterior lumbar surgery ( 31 % with major complication ) The authors conducted a prospect i ve , open , multicenter , observational study to audit the utilization patterns of bemiparin in orthopedic patients in daily clinical practice . They analyzed rates of documented symptomatic venous thromboembolism ( VTE ) ( deep vein thrombosis and pulmonary embolism ) confirmed by objective methods , major bleeding , death , thrombocytopenia , and other adverse events . It was also intended to analyze the influence of concomitant factors ( bemiparin dose , concomitant medications , age , and obesity ) on VTE and bleeding rates . A total of 7959 patients were included and received bemiparin for 28 days ( median ) . Bemiparin 3500 IU/d was used in 84.9 % of patients , whereas bemiparin 2500 IU/d was administered to 15.1 % of patients . Reason for prophylaxis ( number of cases [ % ] ) included cast immobilization of the leg ( 2052 [ 25.8 % ] ) , knee replacement ( 1082 [ 13.6 % ] ) , hip replacement ( 876 [ 11.0 % ] ) , hip fracture surgery ( 437 [ 5.5 % ] ) , other lower limb surgery ( 1569 [ 19.7 % ] ) , knee arthroscopy ( 769 [ 9.7 % ] ) , and spine surgery ( 231 [ 2.9 % ] ) . A total of 943 patients with insufficient data on reason for prophylaxis and 560 patients with no outcome assessment were excluded from the analysis of clinical outcomes . Among 6456 assessable patients , the authors found a low rate of documented symptomatic VTE ( 0.91 % ) , major bleeding ( 0.17 % ) , deaths ( 0.37 % ) , and mild to moderate thrombocytopenia ( 0.51 % ) . None of the major bleedings was fatal or occurred in a critical organ . There were 3 deaths in which fatal pulmonary embolism ( PE ) could not be ruled out . There were no cases of severe type-II thrombocytopenia . VTE rates were not increased in obese patients , and major bleeding rates were not increased in elderly patients or in patients taking nonsteroidal anti-inflammatory drugs . In conclusion , bemiparin prophylaxis , given for 3 to 4 weeks in cast immobilization of the leg and other orthopedic procedures , was associated with low rates of VTE , bleeding , and other adverse events in normal clinical practice Patients undergoing spinal surgery are at risk of developing thromboembolic complications even though lower incidences have been reported as compared to joint arthroplasty surgery . Deep vein thrombosis ( DVT ) has been studied extensively in the context of spinal surgery but symptomatic pulmonary embolism ( PE ) has engaged less attention . We prospect ively followed a consecutive cohort of 270 patients undergoing spinal surgery at a single institution . From these patients , only 26 were simple discectomies , while the largest proportion ( 226 ) was fusions . All patients received both low molecular weight heparin ( LMWH ) initiated after surgery and compressive stockings . PE was diagnosed with spiral chest CT . Six patients developed symptomatic PE , five during their hospital stay . In three of the six patients the embolic event occurred during the first 3 postoperative days . They were managed by the temporary insertion of an inferior vena cava ( IVC ) filter thus allowing for a delay in full-dose anticoagulation until removal of the filter . None of the PE patients suffered any bleeding complication as a result of the introduction of full anticoagulation . Two patients suffered postoperative haematomas , without development of neurological symptoms or signs , requiring emergency evacuation . The overall incidence of PE was 2.2 % rising to 2.5 % after exclusion of microdiscectomy cases . The incidence of PE was highest in anterior or combined thoracolumbar/lumbar procedures ( 4.2 % ) . There is a large variation in the reported incidence of PE in the spinal literature . Results from the only study found in the literature specifically monitoring PE suggest an incidence of PE as high as 2.5 % . Our study shows a similar incidence despite the use of LMWH . In the absence of r and omized controlled trials ( RCT ) it is uncertain if this type of prophylaxis lowers the incidence of PE . However , other studies show that the morbidity of LMWH is very low . Since PE can be a life-threatening complication , LMWH may be a worthwhile option to consider for prophylaxis . RCTs are necessary in assessing the efficacy of DVT and PE prophylaxis in spinal patients Study Design A prospect i ve study was performed . Objectives The goals of the study were to determine the incidence of deep vein thrombosis after major adult spinal surgery and the optimal mode of prophylaxis in this surgical population . Summary of Background Data Few studies have evaluated deep vein thrombosis incidence and prophylaxis after major adult spinal surgery . Incidence rates have ranged from 0.9‐14 % . Methods Three hundred twenty‐nine patients were evaluated . One hundred ten patients were r and omized to 3 different deep vein thrombosis prophylaxis groups . These patients had duplex doppler scans between the fifth and seventh postoperative days . The remaining 219 patients formed a nonr and omized group and received either thrombosis embolic deterrent stockings alone or thrombosis embolic deterrent stockings and pneumatic compression boots for deep vein thrombosis prophylaxis . The type of deep vein thrombosis prophylaxis in this group was based on surgeon preference . All 329 patients were followed for clinical signs and symptoms of thromboembolic disease . Patients were followed clinical ly for a minimum of 1 year . Results All 110 prophylaxis study group patients were clinical ly asymptomatic and 109 duplex scans were normal . One scan was indeterminate and a follow‐up venogram was negative . Two patients in the coumadin group ( 5.7 % ) experienced excessive blood loss . One of the 219 patients from the nonr and omized group developed a clinical ly detectable proximal deep vein thrombosis which was confirmed by duplex ultrasonography . The overall clinical incidence of deep vein thrombosis was 0.3 % ( 1 in 329 patients ) . Conclusions This low 0.3 % rate is in agreement with recent studies that focus on thromboembolic disease . Given the low incidence , routine screening for asymptomatic thrombi appears unwarranted . In addition , mechanical prophylaxis with graduated compression stockings and pneumatic compression boots is preferable to anticoagulation therapy STUDY DESIGN A prospect i ve study of 313 patients who underwent major spinal surgery . OBJECTIVES To determine the incidence of deep vein thrombosis after major spinal surgery in an east Asian population without antithrombotic prophylaxis . SUMMARY OF BACKGROUND DATA Spinal surgery has been associated with few thrombotic complications ( 2 - 14 % ) compared with other reconstructive surgeries ( 20 - 70 % ) . It has also been well documented that the incidence of deep vein thrombosis in east Asians ( 10 % ) is lower than in westerners ( 20 - 70 % ) in total joint replacements . There has been no previous report on the incidence of deep vein thrombosis after reconstructive spinal surgery in east Asians . METHODS Three hundred thirteen patients who underwent major spinal surgery were evaluated prospect ively . All patients were examined with duplex ultrasonography assessment s of both lower extremities . No specific antithrombotic prophylaxis were used in any patients before or after surgery . RESULTS There were four patients with positive findings of deep vein thrombosis on duplex ultrasonography , and there was only one with clinical ly symptomatic deep vein thrombosis . The overall incidence of thrombotic complications was 1.3 % , and the incidence of symptomatic deep vein thrombosis was 0.3 % . CONCLUSION Considering the low rate of deep vein thrombosis , routine screening and prophylaxis for deep vein thrombosis appears unwarranted in east Asians before or after major spinal surgery Orthopaedic surgeons have always based their clinical care on evidence . Surgeons use evidence to make decisions tailored to an individual patient 's needs and circumstances . The primary sources of evidence for clinicians are studies published in the medical and surgical literature , such as The Journal of Bone and Joint Surgery . In June 2000 , The Journal introduced the quarterly Evidence -Based Orthopaedics section 1 . This section introduces orthopaedic surgeons to recent r and omized trials relevant to the practice of orthopaedic surgery published in forty-two journals other than The Journal of Bone and Joint Surgery . Structured abstract s of these studies are |
1,387 | 12,578,506 | Oral cromolyn sodium may be useful in chronic unexplained diarrhea and appears as effective as and safer than elimination diets .
Alterations of enteric flora may play a role in irritable bowel syndrome , but supporting evidence for bacterial overgrowth or probiotic therapy is lacking | The irritable bowel syndrome is a common disorder associated with a significant burden of illness , poor quality of life , high rates of absenteeism , and high health care utilization .
Management can be difficult and treatment unrewarding ; these facts have led physicians and patients toward alternative therapies .
We explored a variety of treatments that exist beyond the scope of commonly used therapies for irritable bowel syndrome . | 33 patients with refractory irritable bowel syndrome were treated with four 40-minute sessions of hypnotherapy over 7 weeks . 20 improved , 11 of whom lost almost all their symptoms . Short-term improvement was maintained for 3 months without further formal treatment . Hypnotherapy in groups of up to 8 patients was as effective as individual therapy OBJECTIVES : Irritable bowel syndrome is the most common gastrointestinal diagnosis . The symptoms of irritable bowel syndrome are similar to those of small intestinal bacterial overgrowth . The purpose of this study was to test whether overgrowth is associated with irritable bowel syndrome and whether treatment of overgrowth reduces their intestinal complaints . METHODS : Two hundred two subjects in a prospect i ve data base of subjects referred from the community undergoing a lactulose hydrogen breath test for assessment of overgrowth were Rome I criteria positive for irritable bowel syndrome . They were treated with open label antibiotics after positive breath test . Subjects returning for follow-up breath test to confirm eradication of overgrowth were also assessed . Subjects with inflammatory bowel disease , abdominal surgery , or subjects demonstrating rapid transit were excluded . Baseline and after treatment symptoms were rated on visual analog scales for bloating , diarrhea , abdominal pain , defecation relief , mucous , sensation of incomplete evacuation , straining , and urgency . Subjects were blinded to their breath test results until completion of the question naire . RESULTS : Of 202 irritable bowel syndrome patients , 157 ( 78 % ) had overgrowth . Of these , 47 had follow-up testing . Twenty-five of 47 follow-up subjects had eradication of small intestinal bacterial overgrowth . Comparison of those that eradicated to those that failed to eradicate revealed an improvement in irritable bowel syndrome symptoms with diarrhea and abdominal pain being statistically significant after Bonferroni correction ( p < 0.05 ) . Furthermore , 48 % of eradicated subjects no longer met Rome criteria ( χ2= 12.0 , p < 0.001 ) . No difference was seen if eradication was not successful . CONCLUSIONS : Small intestinal bacterial overgrowth is associated with irritable bowel syndrome . Eradication of the overgrowth eliminates irritable bowel syndrome by study criteria in 48 % of subjects BACKGROUND The cause of irritable bowel syndrome ( IBS ) is unknown . It may follow gastroenteritis and be associated with an abnormal gut flora and with food intolerance . Our study was design ed to assess whether these factors were associated with colonic malfermentation . METHODS We carried out a crossover controlled trial of a st and ard diet and an exclusion diet matched for macronutrients in six female IBS patients and six female controls . During the final 72 h on each diet , faecal excretion of fat , nitrogen , starch , and non-starch polysaccharide NSP was measured , and total excretion of hydrogen and methane collected over 24 h in a purpose -built 1.4 m3 whole-body calorimeter . Breath hydrogen and methane excretion were then measured for 3 h after 20 g oral lactulose . FINDINGS The maximum rate of gas excretion was significantly greater in patients than in controls ( 2.4 mL/min IQR 1.7 - 2.6 vs 0.6 , 0.4 - 1.1 ) . Although total gas production in patients was not greater than in controls ( median 527 mL/24 h IQR 387 - 660 vs 412 , 234 - 507 ) , hydrogen production was higher ( 332 , 318 - 478 vs 162 , 126 - 217 , p=0.009 ) . In patients , the exclusion diet reduced symptoms and produced a fall in maximum gas excretion ( 0.5 mL/min IQR 0.3 - 0.7 ) . After lactulose , breath hydrogen was greater on the st and ard than on the exclusion diet . INTERPRETATION Colonic-gas production , particularly of hydrogen , is greater in patients with IBS than in controls , and both symptoms and gas production are reduced by an exclusion diet . This reduction may be associated with alterations in the activity of hydrogen-consuming bacteria . Fermentation may be an important factor in the pathogenesis of IBS CONTEXT Irritable bowel syndrome ( IBS ) is a common functional bowel disorder for which there is no reliable medical treatment . OBJECTIVE To determine whether Chinese herbal medicine ( CHM ) is of any benefit in the treatment of IBS . DESIGN R and omized , double-blind , placebo-controlled trial conducted during 1996 through 1997 . SETTING Patients were recruited through 2 teaching hospitals and 5 private practice s of gastroenterologists , and received CHM in 3 Chinese herbal clinics . PATIENTS A total of 116 patients who fulfilled the Rome criteria , an established st and ard for diagnosis of IBS . INTERVENTION Patients were r and omly allocated to 1 of 3 treatment groups : individualized Chinese herbal formulations ( n = 38 ) , a st and ard Chinese herbal formulation ( n = 43 ) , or placebo ( n = 35 ) . Patients received 5 capsules 3 times daily for 16 weeks and were evaluated regularly by a traditional Chinese herbalist and by a gastroenterologist . Patients , gastroenterologists , and herbalists were all blinded to treatment group . MAIN OUTCOME MEASURES Change in total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life caused by IBS symptoms assessed by patients . RESULTS Compared with patients in the placebo group , patients in the active treatment groups ( st and ard and individualized CHM ) had significant improvement in bowel symptom scores as rated by patients ( P=.03 ) and by gastroenterologists ( P=.001 ) , and significant global improvement as rated by patients ( P=.007 ) and by gastroenterologists ( P=.002 ) . Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms ( P=.03 ) . Chinese herbal formulations individually tailored to the patient proved no more effective than st and ard CHM treatment . On follow-up 14 weeks after completion of treatment , only the individualized CHM treatment group maintained improvement . CONCLUSION Chinese herbal formulations appear to offer improvement in symptoms for some patients with IBS Twenty patients with irritable bowel syndrome ( IBS ) were r and omly assigned either to intensive , individualized cognitive therapy ( 10 sessions over 8 weeks ) or to 8 weeks of daily gastrointestinal ( GI ) symptom monitoring . Pre- to posttreatment evaluations showed significantly ( p = .005 ) greater GI symptom reduction for those receiving cognitive therapy than for those in symptom monitoring . At posttreatment , 80 % of the cognitive therapy group showed clinical ly significant improvement , whereas only 10 % of the monitoring group showed this . Results held up well at a 3-month follow-up . Within the cognitive therapy group , GI symptom reductions correlated significantly with increases in positive and reductions in negative automatic thoughts The aim of this study was to evaluate the effect of a novel laxative preparation , composed of cel and in , aloevera and psyllium in patients with chronic constipation . Thirty-five men and women were r and omized to receive capsules containing cel and in-aloevera-psyllium , or placebo , in a double-blind trial lasting 28 days . Symptoms in the last 2 weeks of the treatment period were compared to those in the 14-day pre-trial basal period . In the cel and in , aloevera and psyllium group , bowel movements became more frequent , the stools were softer and laxative dependence was reduced . In the placebo group , all these parameters were unchanged . Abdominal pain was not reduced in either group . The results of this study show that the preparation is an effective laxative in the treatment of constipation 30 patients with severe refractory irritable-bowel syndrome were r and omly allocated to treatment with either hypnotherapy or psychotherapy and placebo . The psychotherapy patients showed a small but significant improvement in abdominal pain , abdominal distension , and general well-being but not in bowel habit . The hypnotherapy patients showed a dramatic improvement in all features , the difference between the two groups being highly significant . In the hypnotherapy group no relapses were recorded during the 3-month follow-up period , and no substitution symptoms were observed A double-blind crossover trial of oligofructose ( Raftilose P95 ) 2 g three times daily against sucrose ( 1 g ) three times daily was performed in patients suffering from irritable bowel syndrome . Each treatment was followed for 4 wk . Patients consumed a st and ardized diet during the last 14 d of each treatment period , and symptoms were assessed using a previously vali date d question naire . Fecal weight and pH , whole-gut transit time and fasting breath hydrogen concentrations were measured at the start of the study and at the end of each treatment period . Oligofructose produced no significant change in any of these parameters even when patients were divided into those with predominant diarrhea ( n = 14 ) and those with predominant constipation ( n = 7 ) . Oligofructose at a dose of 6 g/d had no therapeutic value in patients with irritable bowel syndrome One hundred two patients with irritable bowel syndrome were studied in a controlled trial of psychological treatment involving psychotherapy , relaxation , and st and ard medical treatment compared with st and ard medical treatment alone . Patients were only selected if their symptoms had not improved with st and ard medical treatment over the previous 6 months . At 3 months , the treatment group showed significantly greater improvement than the controls on both gastroenterologists ' and patients ' ratings of diarrhea and abdominal pain , but constipation changed little . Good prognostic factors included overt psychiatric symptoms and intermittent pain exacerbated by stress , whereas those with constant abdominal pain were helped little by this treatment . This study has demonstrated that psychological treatment is feasible and effective in two thirds of those patients with irritable bowel syndrome who do not respond to st and ard medical treatment In a double-blind , crossover study , wedetermined whether microencapusulated pancreatic enzymesreduce postpr and ial symptoms experienced by healthyvolunteers after ingestion of a high calorie , high fat meal . At 7 AM , 18 subjects ingested 185 g ofcookies ( 1196 calories and 72 g of fat ) with threepancrelipase capsules or a placebo . The severity ofgastrointestinal symptoms and flatus passages wererecorded for 15 - 17 hr , and end-alveolar sample s wereobtained hourly for 10 hr . Ingestion of pancreaticsupplements was associated with a significant ( P = 0.049 ) reduction in bloating over the entire recordingperiod , and with significant reductions in bloating , gas , and fullness during the dinner to bedtime period . Pancreatic supplements had no significant effect onbreath H2 or CH4 concentration . The finding that pancreatic supplements reduce postpr and ial symptoms inhealthy subjects suggests that these supplements alsomight be beneficial in irritable bowelsyndrome Previous research from the United Kingdom has shown hypnotherapy to be effective in the treatment of irritable bowel syndrome ( IBS ) . The current study provides a systematic replication of this work in the United States . Six matched pairs of IBS patients were r and omly assigned to either a gut-directed hypnotherapy ( n=6 ) or to a symptom monitoring wait-list control condition ( n=6 ) in a multiple baseline across subjects design . Those assigned to the control condition were later crossed over to the treatment condition . Subjects were matched on concurrent psychiatric diagnoses , susceptibility to hypnosis , and various demographic features . On a composite measure of primary IBS symptoms , treatment was superior ( p=.016 ) to symptom monitoring . Results from the entire treated sample ( n=11 ; one subject was removed from analysis ) indicate that the individual symptoms of abdominal pain , constipation , and flatulence improved significantly . State and trait anxiety scores were also seen to decrease significantly . Results at the 2-month follow-up point indicated good maintenance of treatment gains . No significant correlation was found between initial susceptibility to hypnosis and treatment gain . A positive relationship was found between the incidence of psychiatric diagnosis and overall level of improvement The effectiveness of ginger ( Zingiber officinale ) as an antiemetic agent was compared with placebo and metoclopramide in 60 women who had major gynaecological surgery in a double‐blind , r and omised study . There were statistically significantly fewer recorded incidences of nausea in the group that received ginger root compared with placebo ( p < 0.05 ) . The number of incidences of nausea in the groups that received either ginger root or metoclopramide were similar . The administration of antiemetic after operation was significantly greater in the placebo group compared to the other two groups ( p < 0.05 ) BACKGROUND Symptoms of at least a subgroup of patients with irritable bowel syndrome may be associated with an alteration in gut flora . Studies on bacterial based therapy have yielded mixed results . AIMS To determine if oral administration of the probiotic Lactobacillus casei strain GG under r and omized placebo controlled conditions improves symptoms in irritable bowel syndrome patients with bloating related symptoms . PATIENTS A total of 25 patients with clinical ly confirmed irritable bowel syndrome ( Rome criteria ) were enrolled in the study . METHODS This was a r and omised double-blind placebo-controlled crossover trial . Lactobacillus GG was administered as enterocoated tablets constituting a daily dosage of 10(10 ) colony forming units . Symptoms were assessed by daily symptom diaries and periodic question naires . RESULTS Twenty-four patients were r and omised ; 19 ( 80 % ) female , mean age 40 years ( range 24 - 60 ) , mean duration of symptoms 4.9 years ( range 0.5 - 18 ) . Nineteen ( 80 % ) patients completed the study . No significant differences were found between Lactobacillus casei strain GG and placebo mean symptom scores for pain , urgency or bloating . A trend was noted , however , for a reduction in the number of unformed bowel motions on Lactobacillus casei strain GG treatment for patients with diarrhoea . CONCLUSIONS Lactobacillus casei strain GG alone did not significantly improve symptoms in this irritable bowel syndrome subgroup . A " diarrhoea predominant " subgroup may warrant further investigation Thirty-four patients with irritable bowel syndrome were r and omly assigned to 1 of 3 treatment conditions : individualized cognitive treatment ( CT ) , self-help support group ( SG ) , or symptom-monitoring waiting-list control ( WL ) . Each of the 3 conditions lasted approximately 8 weeks . Pre- to posttreatment analyses revealed significantly greater reductions in both individual gastrointestinal ( GI ) symptoms and in a composite index for GI symptom change for the CT condition than for the SG or WL conditions . When compared with the SG and WL conditions , the CT condition also showed significant improvement on psychological measures of depression and anxiety . At 3-month follow-up , the results for the CT condition were maintained and revealed further numerical improvements To determine the efficacy and tolerability of an enteric-coated peppermint-oil formulation ( Colpermin ) , we conducted a prospect i ve , r and omized , double-blind , placebo-controlled clinical study in 110 out patients ( 66 men/44 women ; 18–70 years of age ) with symptoms of irritable bowel syndrome . Patients took one capsule ( Colpermin or placebo ) three to four times daily , 15–30 min before meals , for 1 month . Fifty-two patients on Colpermin and 49 on placebo completed the study . Forty-one patients on Colpermin ( 79 % ) experienced an alleviation of the severity of abdominal pain ( 29 were pain-free ) ; 43 ( 83 % ) had less abdominal distension , 43 ( 83 % ) had reduced stool frequency , 38 ( 73 % ) had fewer borborygmi , and 41 ( 79 % ) less flatulence . Corresponding figures for the placebo group were : 21 patients ( 43 % ) with reduced pain ( 4 were pain-free ) 14 ( 29 % ) with reduced distension , 16 ( 32 % ) with reduced stool frequency , 15 ( 31 % ) with fewer borborygmi , and 11 ( 22 % ) with less flatulence . Symptom improvements after Colpermin were significantly better than after placebo ( P<0.05 ; Mann-Whitney U-test ) . One patient on Colpermin experienced heartburn ( because of chewing the capsules ) and one developed a mild transient skin rash . There were no significant changes in liver function test results . Thus , in this trial , Colpermin was effective and well tolerated A double-blind , cross-over , therapeutic , clinical trial of the efficacy of exogenous , microbial beta-D-galactosidase to reduce the symptoms of the irritable bowel syndrome ( IBS ) was conducted in 12 patients whose customary diets regularly included milk . Eight of the 12 subjects ( 67 % ) proved to be lactase-nonpersistent , lactose-maldigesters when challenged with a aqueous dose of 12.5 g. The study lasted 4 months , with the first month a non-intervention , control period and the latter 3 months alternating in the sequence , treatment/placebo/treatment , or placebo/treatment/placebo . When symptoms during trial months were analyzed by the cumulative sum procedure , gastrointestinal symptoms were found to be independent of lactase treatment . We found a positive temporal association of the severity of both gastrointestinal and non-gastrointestinal symptomatology . In population s with a high prevalence of lactose deficiency , IBS symptoms appear to be independent of lactose maldigestion To determine the anti‐emetic effect of ginger as compared to droperidol , 120 patients scheduled to have gynaecological diagnostic laparoscopy as day cases were r and omly allocated into placebo , droperidol , ginger and ginger plus droperidol groups to receive either 2 g of ginger or 1.25 mg of droperidol or both . There were no significant differences in the incidences of postoperative nausea which were 32 % , 20 % , 22 % and 33 % , and vomiting which were 35 % , 15 % , 25 % and 25 % in the four groups , respectively . We conclude that ginger powder , in the dose of 2 g , droperidol 1.25 mg or both are ineffective in reducing the incidence of postoperative nausea and vomiting after day case gynaecological laparoscopy We report two controlled comparisons of a previously vali date d multicomponent ( relaxation , thermal biofeedback , and cognitive therapy ) treatment for irritable bowel syndrome ( IBS ) to an ostensible attention-placebo control ( pseudo-meditation and EEG alpha suppression biofeedback ) and to a symptom-monitoring control . In Study 1 ( n = 10 per condition ) there were nonsignificant trends for the multicomponent treatment to be superior to the attention-placebo condition . In Study 2 ( n = 30 per condition ) , we found no advantage for the multicomponent treatment over the attention-placebo condition . Subjects in both treatment conditions showed significant reductions in GI symptoms , as measured by daily symptom diaries , and significant reductions in trait anxiety and depression . The GI symptom reductions held up over a 6 month follow-up . Possible explanations for the results are explored Design and methods Prospect ively , the effect of a lactose-restricted diet was evaluated among irritable bowel syndrome patients with lactose malabsorption . Lactose malabsorption was defined by a positive hydrogen breath test and a positive blood-glucose test . An analysis of symptoms was completed before , during , 6 weeks after and 5 years after starting the diet . In addition , the number of visits made by the patients to the outpatient clinic was scored during 6 years . Results In 17 out of 70 irritable bowel syndrome patients ( 24.3 % ) , lactose malabsorption was detected . There was no difference in the symptom score between patients with a positive lactose tolerance test and patients with a negative lactose tolerance test . After 6 weeks of the lactose-restricted diet , symptoms were markedly improved in lactose malabsorption-positive patients ( P < 0.001 ) . After 5 years , one patient was lost for follow-up , and 14 out of the remaining 16 lactose malabsorption patients ( 87.5 % ) still had no complaints during the lactose-restricted diet . Two patients chose not to follow the diet continuously and accepted the discomfort caused by lactose intake . Only two out of 16 patients ( 12.5 % ) no longer experienced any benefit from lactose restriction . In the 5 years before their diagnosis of lactose malabsorption , these 16 patients visited the outpatient clinic a total of 192 times ( mean 2.4 visits per year per person ; range 1–7 visits ) . In the 5 years after diagnosis , they visited the outpatient clinic a total of 45 times ( mean 0.6 visits per year per person ; range 0–6 visits ; P < 0.0001 ) . Conclusions In a large majority of irritable bowel syndrome patients with lactose malabsorption , which was previously clinical ly unrecognized , a lactose-restricted diet improved symptoms markedly both in the short term and the long term . Furthermore , visits by all patients to the outpatient clinic were reduced by 75 % . We conclude that diet therapy is extremely cost- and time-saving . Therefore , it is strongly recommended that lactose malabsorption , which is easily treatable , is excluded before diagnosing irritable bowel syndrome Lactose malabsorption may induce abdominal symptoms indistinguishable from those of the irritable bowel syndrome ( IBS ) , however the exact relationship between the two conditions and the optimal differential diagnostic workup are still to be defined . We prospect ively studied the prevalence of lactose malabsorption ( by means of a hydrogen breath test ) and the clinical effect of a long-term lactose-free diet in 230 consecutive patients with a suggested diagnosis of irritable bowel syndrome , no organic disease of the GI tract , and no history of milk intolerance . Lactose malabsorption was diagnosed in 157 patients ( 68.2 % ) . In 48 ( 43.6 % ) of the 110 patients who complied with the diet symptoms subsided , in 43 they were somewhat reduced and in 17 they remained unchanged . Symptoms never fully subsided in lactose malabsorbers non-compliant with the diet or in normal lactose absorbers who adhered to a lactose-free regimen . Partial improvement was observed in 20 % of these subjects . No relation was demonstrated between pre-trial symptoms and the outcome of the diet . The occurrence of symptoms during the lactose breath test strongly suggested a favorable response to diet , but did not help in predicting whether symptoms would subside or be reduced . Conversely , their absence during the test was not associated with an acceptable negative predictive value . The high prevalence of lactose malabsorption in the patients under study suggests that in Italy IBS and lactose malabsorption are frequently associated . A test for diagnosing lactose malabsorption should always be included in the diagnostic workup for IBS and a long-term lactose-free regimen recommended if the test is positive OBJECTIVE : Although the st and ard treatments for the irritable bowel syndrome ( IBS ) are medical , growing evidence indicates the substantial therapeutic value of psychological therapy . However , it has not been investigated whether the combination of multicomponent behavioral therapy plus medical treatment is more effective than medical treatment alone . The aim of this study was to investigate this question in patients consulting a tertiary gastrointestinal ( GI ) referral center . METHODS : Twenty-four IBS out patients were r and omly assigned to the combination of st and ardized multicomponent behavioral therapy plus st and ard medical treatment ( SMBT ) or st and ard medical treatment alone ( SMT ) . SMBT included IBS information and education , progressive muscle relaxation , training in illness-related cognitive coping strategies , problem-solving , and assertiveness training in 10 sessions over 10 wk . SMT included st and ardized symptom-oriented medical treatment and regular visits to a gastroenterologist every second week . Posttreatment outcome measures consisted of quantification of GI , vegetative , and psychological symptoms by means of daily symptom diaries and the assessment of changes in rectovisceral perception thresholds , as well as of question naire measures on psychological distress , overall well-being , illness-related coping abilities , and quality of life . Follow-ups were conducted at 3- and 6-month intervals . RESULTS : Pre- and posttreatment evaluations showed significantly ( p < 0.01 ) greater IBS symptom reduction as measured by daily symptom diaries for the SMBT group than for the SMT group . Rectovisceral perception remained unchanged by either treatment . Overall well-being significantly improved in the SMBT group but remained unchanged in the SMT group . Subjects in the SMBT group , unlike those in the SMT group , felt significantly more in control of their health , and quality of life was significantly improved in the SMBT group but remained unchanged in the SMT group . CONCLUSIONS : The data provide evidence that the combination of medical treatment plus multicomponent behavioral treatment is superior to medical treatment alone in the therapy of IBS OBJECTIVE : Using interview data from a large , community-based sample of American women , we assessed the lifetime prevalence of irritable bowel syndrome ( IBS ) using questions consistent with the Rome II criteria , determined the sensitivity of Rome I and II in women diagnosed with IBS by their community physician , and identified whether there are differences in the patients identified by Rome I versus II . METHODS : A geographically diverse national probability sample of women diagnosed with IBS was identified and interviewed by telephone screening of a national , r and om digit dialing sample of households . A parallel national survey of adult females was conducted to determine the lifetime prevalence of IBS in U.S. women . Screening and interviews were conducted by experienced , female interviewers . IBS was defined by variations on the Rome I/II criteria . RESULTS : In the national community sample , lifetime IBS prevalence was 5.4 % using Rome II . Full interviews were completed in 1014 IBS patients . In the IBS sample , Rome I was significantly more sensitive than Rome II ( 84 % vs 49 % , p < 0.001 ) . There was 47 % agreement between Rome I and II . Of patients with IBS by Rome I , 58 % met Rome II . Only 17.7 % did not meet either Rome I or II . CONCLUSION : Rome I was more sensitive than Rome II in this community sample of female IBS patients . Rome I/II do not necessarily identify the same IBS patients . These findings have important implication s for clinical research in IBS patients and raise questions about whether the Rome II criteria are sensitive enough to be useful in clinical practice The irritable bowel syndrome is a highly prevalent condition whose underlying aetiology is not understood . While many patients respond to a combination of gastrointestinal antispasmodics , bulking agents and dietary manipulation , controlled clinical trials have suggested that the benefit is only marginal and is due mainly to the large placebo effect found in this condition , which has been calculated to range between 54 and 81 % . Associations between the syndrome and psychological and social stresses suggest , however , that treatment involving a systematic approach to the management of symptoms may hold out real therapeutic possibilities . In the current study , 42 IBS patients were r and omly allocated to either medical treatment or to behavioural psychotherapy with a nurse therapist . They were assessed initially and at 4 and 9 months . There was a general improvement over the 9 months on a number of physical and psychological symptoms measured . However , no differences were found between treatment groups except for changes in two avoidance scores . A significant correlation was found , however , between improvement in the bowel symptoms of IBS ( stomach pain and diarrhoea ) and improvement in the psychological symptoms measured by the Clinical Interview Schedule , suggesting a close interrelationship between the two OBJECTIVE : The influence of the gastrointestinal ( GI ) microflora in patients with irritable bowel syndrome ( IBS ) has not been clearly eluci date d. This study was undertaken to see if patients with IBS have an imbalance in their normal colonic flora , as some bacterial taxa are more prone to gas production than others . We also wanted to study whether the flora could be altered by exogenous supplementation . In a previous study we have characterized the mucosa-associated lactobacilli in healthy individuals and found some strains with good colonizing ability . Upon colonization , they seemed to reduce gas formation . METHODS : The study comprised 60 patients with IBS and a normal colonoscopy or barium enema . Patients fulfilling the Rome criteria , without a history of malabsorption , and with normal blood tests underwent a sigmoidoscopy with biopsy . They were r and omized into two groups , one receiving 400 ml per day of a rose-hip drink containing 5 × 107 cfu/ml of Lactobacillus plantarum ( DSM 9843 ) and 0.009 g/ml oat flour , and the other group receiving a plain rose-hip drink , comparable in color , texture , and taste . The administration lasted for 4 wk . The patients recorded their own GI function , starting 2 wk before the study and continuing throughout the study period . Twelve months after the end of the study all patients were asked to complete the same question naire regarding their symptomatology as at the start of the study . RESULTS : All patients tolerated the products well . The patients receiving Lb . plantarum had these bacteria on rectal biopsies . There were no major changes of Enterobacteriaceae in either group , before or after the study , but the Enterococci increased in the placebo group and remained unchanged in the test group . Flatulence was rapidly and significantly reduced in the test group compared with the placebo group ( number of days with abundant gas production , test group 6.5 before , 3.1 after vs 7.4 before and 5.6 after for the placebo group ) . Abdominal pain was reduced in both groups . At the 12-month follow-up , patients in the test group maintained a better overall GI function than control patients . There was no difference between the groups regarding bloating . Fifty-nine percent of the test group patients had a continuous intake of fermented products , whereas the corresponding figure for the control patients was 73 % . CONCLUSIONS : The results of the study indicate that the administration of Lb . plantarum with known probiotic properties decreased pain and flatulence in patients with IBS . The fiber content of the test solution was minimal and it is unlikely that the fiber content could have had any effect . This type of probiotic therapy warrants further studies in IBS patients Patients with chronic , refractory irritable bowel syndrome ( n = 102 ) were entered into a r and omised controlled trial of psychotherapy versus supportive listening . Independent physical and psychological assessment s were carried out at the beginning and end of the 12-week trial . For women , psychotherapy was found to be superior to supportive listening , in terms of an improvement in both physical and psychological symptoms . There was a similar trend for men , but this did not reach significance . Following completion of the trial , patients in the control group were offered psychotherapy ; 33 accepted and following treatment experienced a marked improvement in their symptoms ; ten declined . At follow-up one year later , those patients who had received psychotherapy remained well , patients who had dropped out of the trial were unwell with severe symptoms , and most of the controls who declined psychotherapy had relapsed . This study shows that psychotherapy is feasible and effective in the majority of irritable bowel syndrome patients with chronic symptoms unresponsive to medical treatment BACKGROUND Although previous studies have shown that psychological disturbances are frequently associated with the irritable bowel syndrome ( IBS ) , the relation was not necessarily cause and effect . The development of chronic bowel symptoms resembling IBS after an episode of acute gastroenteritis has allowed us to examine prospect ively the role of psychological factors . METHODS 75 patients with acute gastroenteritis completed a series of psychometric tests soon after admission to hospital . Of these , 22 had persistent symptoms compatible with IBS after the acute illness , and in 20 of these the symptoms were still present at six months . FINDINGS At the time of their initial illness , patients who subsequently developed IBS symptoms had higher scores for anxiety , depression , somatisation , and neurotic trait than those who returned to normal bowel function . The psychometric scores had not changed when remeasured three months after the acute illness . Lactose malabsorption was not an important factor . INTERPRETATION These results support the hypothesis that psychological factors are important in IBS In a double-blind r and omized placebo trial , the effect of the powdered rhizome of ginger ( Zingiber officinale ) was tested on seasickness . Eighty naval cadets , unaccustomed to sailing in heavy seas reported during voyages on the high seas , symptoms of seasickness every hour for 4 consecutive hours after ingestion of 1 g of the drug or placebo . Ginger root reduced the tendency to vomiting and cold sweating significantly better than placebo did ( p less than 0.05 ) . With regard to vomiting , a modified Protection Index ( PI ) = 72 % was calculated . Remarkably fewer symptoms of nausea and vertigo were reported after ginger root ingestion , but the difference was not statistically significant . For all symptom categories , PI = 38 % was calculated Food hypersensitivity as a cause of abdominal symptoms was investigated by means of exclusion diets and double-blind food provocation in patients with irritable bowel syndrome . Twenty-seven patients entered the study ; nineteen complied with dietary manipulation . Food hypersensitivity as a cause of their presenting symptoms was confirmed by double-blind food provocation in only three patients , who also had evidence of associated atopic disease and positive skin tests to common inhalant allergens . Evidence of minor psychiatric disorder was found in twelve of fourteen patients examined by an independent psychiatrist The effect of powdered ginger root was compared with metoclopramide and placebo . In a prospect i ve , r and omised , double‐blind trial the incidence of postoperative nausea and vomiting was measured in 120 women presenting for elective laparoscopic gynaecological surgery on a day stay basis . The incidence of nausea and vomiting was similar in patients given metoclopramide and ginger ( 27 % and 21 % ) and less than in those who received placebo ( 41 % ) . The requirement for postoperative antiemetics was lower in those patients receiving ginger . The requirements for postoperative analgesia , recovery time and time until discharge were the same in all groups . There was no difference in the incidence of possible side effects such as sedation , abnormal movement , itch and visual disturbance between the three groups . Zingiber officinale is an effective and promising prophylactic antiemetic , which may be especially useful for day case Twenty patients with persistent diarrhoea participated in a r and omised , double-blind trial of oral sodium cromoglycate and placebo . Eight patients noted significant improvement in their diarrhoea while taking sodium cromoglycate and this did not correlate with the presence of other atopic diseases , a history of food intolerance , or the presence of lactase deficiency . The results suggest that some patients with diarrhoea of unknown cause may have food allergy as a major contributing cause for their diarrhoea BACKGROUND In a significant number of patients affected by the irritable bowel syndrome , an adverse reaction to food is proposed to be a causative factor . A diet that eliminates the offending foods is the obvious treatment for such adverse reactions . Compliance with a dietetic regimen is often poor and sometimes not completely free from risks . METHODS Since the diarrheic type of irritable bowel syndrome seems mainly affected by food intolerance , and previous observations suggested that oral cromolyn sodium is effective in such patients , a multicenter therapeutic trial in the diarrheic type of irritable bowel syndrome was carried out in 346 of 409 patients with this disease , to evaluate the effects of oral cromolyn sodium and compare its efficacy with that of an elimination diet . RESULTS Symptoms related to the irritable bowel syndrome improved in 60 % of patients treated with elimination diet and in 67 % of those treated with oral cromolyn sodium ( 1500 mg/day ) for 1 month . Moreover , in both groups clinical results were significantly better in the patients positive to the skin prick test than in the negative ones . CONCLUSIONS These results confirm the high prevalence of adverse reactions to foods in diarrheic irritable bowel syndrome and the usefulness of cromolyn sodium treatment in these patients Thirty women participated in a double-blind r and omized cross-over trial of the efficacy of a natural product , the powdered root of ginger ( Zingiber officinale ) , and placebo in hyperemesis gravidarum . Three patients had to be withdrawn . Each woman swallowed capsules containing either 250 mg ginger or lactose q.i.d . during the first 4 days of the treatment period . Interrupted by a 2 days wash-out period the alternative medication was given in the second 4-day period . The severity and relief of symptoms before and after each period were evaluated by two scoring systems . The scores were used for statistical analyses of possible differences . Subjectively assessed , 19 women ( 70.4 % ) stated preference to the period in which ginger , as was later disclosed , had been given ( P = 0.003 ) . More objective ly assessed by relief scores a significantly greater relief of the symptoms was found after ginger treatment compared to placebo ( P = 0.035 ) . No side effects were observed . The possible mutagenic and antimutagenic characters of ginger reported in a study of E. coli have not been evaluated with respect to any significance in humans . Powdered root of ginger in daily doses of 1 g during 4 days was better than placebo in diminishing or eliminating the symptoms of hyperemesis gravidarum Our objective was to obtain national data of the estimated prevalence , sociodemographic relationships , and health impact of persons with functional gastrointestinal disorders . We surveyed a stratified probability r and om sample of U.S householders selected from a data base of a national market firm ( National Family Opinion , Inc. ) . Questions were asked about bowel symptoms , sociodemographic associations , work absenteeism , and physician visits . The sampling frame was constructed to be demographically similar to the U.S. householder population based on geographic region , age of householder , population density , household income and household size . Of 8250 mailings , 5430 were returned suitable for analysis ( 66 % response ) . The survey assessed the prevalence of 20 functional gastrointestinal syndromes based on fulfillment of multinational diagnostic ( Rome ) criteria . Additional variables studied included : demographic status , work absenteeism , health care use , employment status , family income , geographic area of residence , population density , and number of persons in household . For this sample , 69 % reported having at least one of 20 functional gastrointestinal syndromes in the previous three months . The symptoms were attributed to four major anatomic regions : esophageal ( 42 % ) , gastroduodenal ( 26 % ) , bowel ( 44 % ) , and anorectal ( 26 % ) , with considerable overlap . Females reported greater frequencies of globus , functional dysphagia , irritable bowel syndrome , functional constipation , functional abdominal pain , functional biliary pain and dyschezia ; males reported greater frequencies of aerophagia and functional bloating . Symptom reporting , except for incontinence , declines with age , and low income is associated with greater symptom reporting . The rate of work/school absenteeism and physician visits is increased for those having a functional gastrointestinal disorder . Furthermore , the greatest rates are associated with those having gross fecal incontinence and certain more painful functional gastrointestinal disorders such as chronic abdominal pain , biliary pain , functional dyspepsia and IBS . Preliminary information on the prevalence , socio-demographic features and health impact is provided for persons who fulfill diagnostic criteria for functional gastrointestinal disorders 101 out patients with irritable bowel syndrome were r and omly allocated to two treatment groups . Both groups received the same medical treatment , but patients in one group also received dynamically oriented individual psychotherapy in ten hour-long sessions spread over 3 months . After 3 months there was a significantly greater improvement in somatic symptoms in the psychotherapy group . The difference became more pronounced a year later , with the patients given psychotherapy showing further improvement , and the patients who received medical treatment showing some deterioration . The combination of medical treatment with psychotherapy improves outcome , not only in the short term but also in the long run The incidence of imported malaria in the UK has steadily increased during the past decade , ' with 1909 cases reported in 1978 . At St Thomas 's Hospital P falciparunz malaria is much commoner than P vivax and is mostly acquired in tropical Africa.2 Most of the malaria reported in Asian immigrants is P vivax,5 and , although the World Health Organisation has reported an increase in the incidence of falciparum malaria in Bangladesh , India , and Sri Lanka , ' we have not previously seen a falciparum infection in an Asian . Chloroquineresistant falciparum malaria has been reported in South-east Asia and South America for many years , but its occurrence in the Asian subcontinent and in East Africa is much more recent . Two cases of imported chloroquine-resistant falciparum infections have recently occurred in the UK ; both were from Kenya and one was fatal.4 Our patient would appear to have shown RI resistance to chloroquine in that parasites reappeared after 23 days , although the initial course of chloroquine had apparently eradicated the infection . We made no attempt to culture the malarial parasites to confirm in-vitro resistance . This patient probably acquired her malaria from blood transfusion in Bangladesh , and there have been no reports of chloroquine-resistant P falciparum being transmitted by this route , although transfusion malaria is known to be common and underreported in the developing countries , and many cases of falciparum are described.5 Malaria in our patient was initially diagnosed by chance when blood films were being examined . The patient at this time was relatively well and afebrile , and malaria was not suspected clinical ly . The resurgence of the falciparum was unexpected and delayed diagnosis in view of the many other possible causes of fever in a neutropenic postoperative patient with leukaemia . Malaria was not initially entertained as a likely diagnosis because of the apparently successful treatment with chloroquine . It is of interest that the clinical response to intravenous quinine was slow , particularly defervescence , and perhaps " quinine fever " may have been contributory . The disappearance of parasites was also slow ; indeed , the parasitaemia appeared unchanged after two infusions of quinine . Although we are unaware of the effect of severe neutropenia and immunosuppression on the clinical course of malaria , it seems likely that this patient was infected with a chloroquine-resistant strain of P falciparum The efficacy of ginger for the prevention of postoperative nausea and vomiting was studied in a double-blind , r and omized , controlled trial in 108 ASA 1 or 2 patients undergoing gynaecological laparoscopic surgery under general anaesthesia . Patients received oral placebo , ginger BP 0.5 g or ginger BP 1.0 g , all with oral diazepam premedication , one hour prior to surgery . Patients were assessed at three hours postoperatively . The incidence of nausea and vomiting increased slightly but nonsignificantly with increasing dose of ginger . The incidence of moderate or severe nausea was 22 , 33 and 36 % , while the incidence of vomiting was 17 , 14 and 31 % in groups receiving 0 , 0.5 and 1.0 g ginger , respectively ( odds ratio per 0.5 g ginger 1.39 for nausea and 1.55 for vomiting ) . These results were essentially unchanged when adjustment was made for concomitant risk factors . We conclude that ginger BP in doses of 0.5 or 1.0 gram is ineffective in reducing the incidence of postoperative nausea and vomiting Thirty-five patients with irritable bowel syndrome were r and omized to receive treatment in a stress management programme or conventional therapy which included the antispasmodic Colpermin . The stress management programme involved a median of six 40-min sessions with a physiotherapist during which patients were helped to underst and the nature of their symptoms , their relationship to stress and were taught relaxation exercises . Two thirds of those in the stress management programme found the programme effective in relieving symptoms and experienced fewer attacks of less severity . This benefit was maintained for at least 12 months . Few of those given conventional management had any benefit . A stress management programme would appear to be of value for patients with irritable bowel syndrome |
1,388 | 27,130,722 | TAM induces BD reduction ; however , the effect of RLX , tibolone , and AIs on BD is unclear .
Although data on association between diet and BD in adulthood are contradictory , intake of vegetables , vitamin D , and calcium appear to be associated with lower BD in premenopausal women | Background .
Lower breast density ( BD ) is associated with lower risk of breast cancer and may serve as a biomarker for the efficacy of chemopreventive strategies .
This review explores parameters that are thought to be associated with lower BD . | Background : A better underst and ing of factors that affect breast density , one of the strongest breast cancer risk indicators , may provide important clues about breast cancer etiology and prevention . This study evaluates the association of vitamin D and calcium , from food and /or supplements , to breast density in premenopausal and postmenopausal women separately . Methods : A total of 777 premenopausal and 783 post-menopausal women recruited at two radiology clinics in Quebec City , Canada , in 2001 to 2002 , completed a food frequency question naire to assess vitamin D and calcium . Breast density from screening mammograms was assessed using a computer-assisted method . Associations between vitamin D or calcium and breast density were evaluated using linear regression models . Adjusted means in breast density were assessed according to the combined daily intakes of the two nutrients using generalized linear models . Results : In premenopausal women , total intakes of vitamin D and calcium were inversely related to breast density ( β = −1.4 ; P = 0.004 for vitamin D ; β = −0.8 ; P = 0.0004 for calcium ) . In multivariate linear regression , simultaneous increments in daily total intakes of 400 IU vitamin D and 1,000 mg calcium were associated with an 8.5 % ( 95 % confidence interval , 1.8 - 15.1 ) lower mean breast density . The negative association between dietary vitamin D intake and breast density tended to be stronger at higher levels of calcium intake and vice versa . Among postmenopausal women , intakes of vitamin D and calcium were not associated with breast density . Conclusion : These findings show that higher intakes of vitamin D and calcium from food and supplements are related to lower levels of breast density among premenopausal women . They suggest that increasing intakes of vitamin D and calcium may represent a safe and inexpensive strategy for breast cancer prevention BACKGROUND Whether a change over time in clinical ly measured mammographic breast density influences breast cancer risk is unknown . METHODS From January 1993 to December 2003 , data that included American College of Radiology Breast Imaging Reporting and Data System ( BI-RADS ) breast density categories ( 1 - 4 in order of increasing density ) were collected prospect ively on 301,955 women aged 30 and older who were not using postmenopausal hormone replacement therapy and underwent at least two screening mammography examinations ; 2639 of the women were diagnosed with breast cancer within 1 year of the last examination . Women 's first and last BI-RADS breast density ( average 3.2 years apart ) and logistic regression were used to model the odds of having invasive breast cancer or ductal carcinoma in situ diagnosed within 12 months of the last examination by change in BI-RADS category . Rates of breast cancer adjusted for age , mammography registry , and time between screening examinations were estimated from this model . All statistical tests were two-sided . RESULTS The rate ( breast cancers per 1000 women ) of breast cancer was higher if BI-RADS breast density category increased from 1 to 2 ( 5.6 , 95 % confidence interval [ CI ] = 4.7 to 6.9 ) or 1 to 3 ( 9.9 , 95 % CI = 6.4 to 15.5 ) compared to when it remained at BI-RADS density of 1 ( 3.0 , 95 % CI = 2.3 to 3.9 ; P<.001 for trend ) . Similar and statistically significant trends between increased or decreased density and increased or decreased risk of breast cancer , respectively , were observed for women whose breast density category was initially 2 or 3 and changed categories . BI-RADS density of 4 on the first examination was associated with a high rate of breast cancer ( range 9.1 - 13.4 ) that remained high even if breast density decreased . CONCLUSION An increase in BI-RADS breast density category within 3 years may be associated with an increase in breast cancer risk and a decrease in density category with a decrease in risk compared to breast cancer risk in women in whom breast density category remains unchanged . Two longitudinal measures of BI-RADS breast density may better predict a woman 's risk of breast cancer than a single measure BACKGROUND Mammographic breast density is a strong risk factor for breast cancer . Tamoxifen , which reduces the risk of breast cancer in women at high risk , also reduces mammographic breast density . However , it is not known if tamoxifen-induced reductions in breast density can be used to identify women who will benefit the most from prophylactic treatment with this drug . METHODS We conducted a nested case-control study within the first International Breast Cancer Intervention Study , a r and omized prevention trial of tamoxifen vs placebo . Mammographic breast density was assessed visually and expressed as a percentage of the total breast area in 5 % increments . Case subjects were 123 women diagnosed with breast cancer at or after their first follow-up mammogram , which took place 12 - 18 months after trial entry , and control subjects were 942 women without breast cancer . Multivariable logistic regression was used to adjust for other risk factors . All statistical tests were two-sided . RESULTS In the tamoxifen arm , 46 % of women had a 10 % or greater reduction in breast density at their 12- to 18-month mammogram . Compared with all women in the placebo group , women in the tamoxifen group who experienced a 10 % or greater reduction in breast density had 63 % reduction in breast cancer risk ( odds ratio = 0.37 , 95 % confidence interval = 0.20 to 0.69 , P = .002 ) , whereas those who took tamoxifen but experienced less than a 10 % reduction in breast density had no risk reduction ( odds ratio = 1.13 , 95 % confidence interval = 0.72 to 1.77 , P = .60 ) . In the placebo arm , there was no statistically significant difference in breast cancer risk between subjects who experienced less than a 10 % reduction in mammographic density and subjects who experienced a greater reduction . CONCLUSION The 12- to 18-month change in mammographic breast density is an excellent predictor of response to tamoxifen in the preventive setting Background : Mammographic density is a risk factor for breast cancer . Mammographic density and breast magnetic resonance imaging ( MRI ) volume ( MRIV ) assess the amount of fibrogl and ular tissue in the breast . Mammographic density and MRIV can be modulated with hormonal interventions , suggesting that these imaging modalities may be useful as surrogate endpoint biomarkers for breast cancer chemoprevention trials . We evaluated the effect of raloxifene on mammographic density and MRIV in premenopausal women at increased risk for breast cancer . Methods : Mammograms and MRI were obtained at baseline and after 1 and 2 years of 60 mg raloxifene by mouth daily for 27 premenopausal women . Mammographic percent dense area was calculated using a semiquantitative thresholding technique . T1-weighted spoiled gradient-echo MRI with fat suppression was used to determine breast MRIV using a semiautomatic method . Mean change in mammographic density and median change in MRIV were assessed by the Wilcoxon signed-rank test . Results : No significant change in mammographic density was seen after treatment with raloxifene . Mean change after 1 year was 1 % [ 95 % confidence interval ( 95 % CI ) , −3 to + 5 ] and after 2 years was 1 % ( 95 % CI , −2 to + 5 ) . MRIV decreased on raloxifene . Median relative change in MRIV after 1 year was -17 % ( 95 % CI , -28 to -9 ; P = 0.0017 ) and after 2 years was -16 % ( 95 % CI , -31 to -4 ; P = 0.0004 ) . Conclusions : In high-risk premenopausal women , mammographic density did not change on raloxifene , whereas MRIV significantly declined . Our findings suggest that MRIV is a promising surrogate biomarker in premenopausal women at increased risk for breast cancer and should be investigated further in breast cancer prevention trials . ( Cancer Epidemiol Biomarkers Prev 2008;17(7):1696–701 Background : Calcium and vitamin D may be inversely related to breast cancer risk , in part by affecting mammographic density . However , results from previous , mostly cross-sectional studies have been mixed , and there have been few r and omized clinical trials of the effect of calcium and vitamin D supplementation on change in mammographic density . Methods : We assessed the effect of one year of supplementation on mammographic density in 330 postmenopausal women enrolled in the Women 's Health Initiative hormone therapy ( HT ) and calcium and vitamin D ( CaD ) trials . Women were r and omized to receive 1,000 mg/d of elemental calcium carbonate plus 400 IU/d of vitamin D3 or placebo . Results : After approximately one year , mammographic density decreased 2 % in the CaD supplementation group and increased 1 % in the placebo group ( ratio of means = 0.97 ; 95 % CI = 0.81–1.17 ) . Results suggested potential interaction by HT use ( P = 0.08 ) . Among women r and omized to HT placebo , the ratio of mean density comparing CaD supplementation and placebo groups was 0.82 ( 95 % CI = 0.61–1.11 ) vs. 1.16 ( 95 % CI = 0.92–1.45 ) in women r and omized to active HT . In sensitivity analyses limited to women taking ≥80 % of study supplements , ratios were 0.67 ( 95 % CI = 0.41–1.07 ) in women not assigned to HT and 1.07 ( 95 % CI = 0.79–1.47 ) women assigned to HT . Conclusions : We observed no overall effect of vitamin D and calcium supplementation on mammographic density after one year . Impact : Potential interaction between these nutrients and estrogen as related to mammographic density warrants further study . Cancer Epidemiol Biomarkers Prev ; 21(3 ) ; 462–73 . © 2012 AACR Mammographically detected breast density has been correlated with breast cancer risk . Breast density appears to be influenced by hormonal factors including increasing age , postmenopausal status , number of pregnancies , lower body weight , hormone replacement therapy , and tamoxifen therapy . The aromatase inhibitor letrozole profoundly reduces breast and circulating estrogen levels in postmenopausal women . We hypothesize that letrozole may reduce breast density and report here on its effects on mammographic breast density , bone mineral density ( BMD ) , bone biomarkers , plasma hormone , and serum lipid levels . MAP1 was a multicenter , r and omized , double-blind , placebo-controlled , feasibility trial in which postmenopausal women with or without prior invasive breast cancer were r and omized in a 2:1 ratio of letrozole ( 2.5 mg daily ) or placebo for 12 months and followed for a total of 24 months . Eligible women had an estimated > 25 % breast density on baseline mammogram . The primary endpoint was change in percent breast density ( PD ) between the baseline and 12-month mammograms as estimated by a computer-assisted thresholding program . Baseline and 12-month mammographic density was also assessed in a blinded manner by visual inspection . Secondary endpoints included changes in serum hormones , plasma lipid levels , bone biomarkers , and BMD . Data are available for 67 women ( 44 on letrozole and 23 on placebo ) . No significant changes in PD were noted between the treatment arms at either 12 or 24 months . No distinguishable difference in density measurements by visual inspection were noted between baseline and 12-month mammograms . A significant decrease in percentage change in T-score of the femoral neck at 12 months was noted in the letrozole arm without other significant changes in BMD parameters . Lipid values did not differ between treatment groups except for a borderline significant decrease in total cholesterol at 3 months among women treated with letrozole . Letrozole therapy was associated with a significant reduction in mean serum estradiol , estrone , and estrone sulfate levels at 12 months , but not at 24 months . A significant increase in serum IGF-1 levels was also noted in the letrozole group compared to the placebo group at both 12 and 24 months . To conclude , compared with placebo , 12 months of letrozole therapy does not appear to have a significant effect on mammographic PD . Twelve months of letrozole was associated with a decrease of uncertain clinical significance in the T-score of the femoral neck at 12 months which was reversible at 24 months with recovery of estrogen levels . Letrozole therapy was found to increase IGF-1 levels at 12 and 24 months Soy consumption may be related to lower breast cancer risk as assessed by breast density . The aims of this 2-y trial were to examine the effects of soy foods and lifetime soy intake on mammographic density . After 220 premenopausal women were r and omly assigned to the intervention or control group , the former group consumed 2 daily servings of soy foods equivalent to 50 mg of isoflavones and the latter consumed their regular diet . The respective dropout rates were 15.6 and 12.6 % ; adherence to the study regimen was high . We assessed lifetime soy intake with a question naire and measured breast density in screening mammograms obtained at baseline and at the end of the trial for 98 intervention and 103 control women using a computer-assisted method . None of the mammographic outcomes differed significantly by experimental group . The total area of the breast increased and the size of the dense areas decreased significantly over time in both groups . After 2 y , the mean percentage density had decreased by 2.8 and 4.1 % in intervention and control women , respectively . Women who reported eating more soy during their lives had higher percentage densities than women whose diet included little soy ; this difference was significant only in Caucasians . Lower soy intake during early life and higher soy intake during adulthood predicted a greater reduction in the percentage density during the study period . After 2 y of intervention , we observed no significant differences in mammographic densities by intervention status , but it appears that soy consumption throughout life may have some effect on breast density Introduction Isoflavones are hypothesized to protect against breast cancer , but it is not clear whether they act as oestrogens or anti-oestrogens in breast tissue . Our aim was to determine the effects of taking a red clover-derived isoflavone supplement daily for 1 year on mammographic breast density . Effects on oestradiol , follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , lymphocyte tyrosine kinase activity and menopausal symptoms were also assessed . Methods A total of 205 women ( age range 49–65 years ) with Wolfe P2 or DY mammographic breast patterns were r and omly assigned to receive either a red clover-derived isoflavone tablet ( 26 mg biochanin A , 16 mg formononetin , 1 mg genistein and 0.5 mg daidzein ) or placebo . Change in mammographic breast density , serum oestradiol , FSH , LH , menopausal symptoms and lymphocyte tyrosine kinase activity from baseline to 12 months were assessed . Results A total of 177 women completed the trial . Mammographic breast density decreased in both groups but the difference between the treatment and placebo was not statistically significant . There was a significant interaction between treatment group and oestrogen receptor ( ESR1 ) PvuII polymorphism for the change in estimated percentage breast density ( mean ± st and ard deviation ) : TT isoflavone 1.4 ± 12.3 % and TT placebo -9.6 ± 14.2 % ; CT isoflavone -5.2 ± 12.0 % and CT placebo -2.8 ± 10.3 % ; and CC isoflavone -3.4 ± 9.7 % and CC placebo -1.1 ± 9.5 % . There were no statistically significant treatment effects on oestradiol , FSH , or LH ( assessed only in postmenopausal women ) , or on lymphocyte tyrosine kinase activity . Baseline levels of menopausal symptoms were low , and there were no statistically significant treatment effects on frequency of hot flushes or other menopausal symptoms . Conclusion In contrast to studies showing that conventional hormone replacement therapies increase mammographic breast density , the isoflavone supplement did not increase mammographic breast density in this population of women . Furthermore , there were no effects on oestradiol , gonadotrophins , lymphocyte tyrosine kinase activity , or menopausal symptoms A few studies have evaluated the association between diet and mammographic breast density ( MBD ) and results are inconsistent . MBD , a well-recognized risk factor for breast cancer , has been proposed as a marker of cumulative exposure to hormones and growth factors . Diets with a high glycemic index ( GI ) or glycemic load ( GL ) may increase breast cancer risk , via an effect on the insulin-like growth factor axis . We have investigated the association between carbohydrate intake , GI , GL and MBD in a prospect i ve study . We identified a large series of women , in the frame of the EPIC-Florence cohort , with a mammogram taken five years after enrolment , when detailed information on dietary and lifestyle habits and anthropometric measurements had been collected . Mammograms have been retrieved ( 1,668 , 83 % ) and MBD assessed according to Wolfe ’s classification . We compared women with high MBD ( P2+DY Wolfe ’s categories ) with those with low MBD ( N1+P1 ) through logistic models adjusted for age , education , body mass index , menopause , number of children , breast feeding , physical activity , non-alcohol energy , fibers , saturated fat and alcohol . A direct association between GL and high MBD emerged in the highest quintile of intake in comparison with the lowest quintile ( OR = 1.73 , 95%CI 1.13–2.67 , p for trend = 0.048 ) while no association with glycemic index was evident . These results were confirmed after exclusion of women reporting to be on a diet or affected with diabetes , and when Hormone Replacement Therapy at the date of mammographic examination used to assess MBD was considered . The effect was particularly evident among leaner women , although no interaction was found . A positive association was suggested for increasing simple sugar and total carbohydrates intakes limited to the highest quintiles . In this Italian population we observed an association between glycemic load , total and rapidly absorbed carbohydrates and high MBD . These novel results warrant further investigations Background : Adolescent diet is hypothesized to influence breast cancer risk . We evaluated the long-term effects of an intervention to lower fat intake among adolescent girls on biomarkers that are related to breast cancer risk in adults . Methods : A follow-up study was conducted on 230 girls who participated in the Dietary Intervention Study in Children ( DISC ) , in which healthy , prepubertal , 8 to 10 year olds were r and omly assigned to usual care or to a behavioral intervention that promoted a reduced fat diet . Participants were 25 to 29 years old at follow-up visits . All tests of statistical significance are two-sided . Results : In analyses that did not take account of diet at the time of the follow-up visit , the only statistically significant treatment group difference was higher bone mineral content in intervention group participants compared with usual care group participants ; their mean bone mineral contents were 2,444 and 2,377 g , respectively . After adjustment for current diet , the intervention group also had statistically significantly higher bone mineral density and luteal phase serum estradiol concentrations . Serum progesterone concentrations and breast density did not differ by treatment group in unadjusted or adjusted analyses . Conclusions : Results do not support the hypothesis that consumption of a lower fat diet during adolescence reduces breast cancer risk via effects on subsequent serum estradiol and progesterone levels , breast density , or bone mineral density . It remains unclear , however , if the results are specific to the DISC intervention or are more broadly applicable . Impact : Modest reductions in fat intake during adolescence are unlikely to lower later breast cancer risk via long-term effects on the biomarkers measured . Cancer Epidemiol Biomarkers Prev ; 19(6 ) ; 1545–56 . © 2010 AACR OBJECTIVES To determine the effects of continuous combined hormone therapy , tibolone , black cohosh , and placebo on digitized mammographic breast density in postmenopausal women . STUDY DESIGN A prospect i ve , double-blind , placebo-controlled study of 154 postmenopausal women r and omized to estradiol 2 mg/norethisterone acetate 1 mg ( E2/NETA ) , tibolone 2.5 mg or placebo and a prospect i ve , open , uncontrolled drug safety study , of which 65 postmenopausal women were treated with black cohosh . Mammograms , at baseline and after six months of treatment , were previously classified according to visual quantification scales . MAIN OUTCOME MEASURES Re analysis of assessable mammograms by digitized quantification of breast density . RESULTS Treatment groups were comparable at baseline . During treatment , both E2/NETA and tibolone significantly increased breast density ( mean increase 14.3 % , p<0.001 and 2.3 % , p<0.001 , respectively ) , while black cohosh and placebo did not . Twenty-four out of the 43 women on E2/NETA had an increase in density exceeding 10 % and 6 women had an increase of 30 % or more . In the tibolone group , only one woman had an increase in density of more than 10 % . The difference in increase in breast density between E2/NETA on the one h and and tibolone , black cohosh and placebo on the other was highly significant ( p<0.0001 ) . CONCLUSIONS Digitized mammographic breast density is a highly sensitive method confirming significant increase in density by st and ard E2/NETA treatment and to a lesser extent by tibolone , whereas black cohosh does not influence mammographic breast density during six months treatment . Digitized assessment also yields data on individual variation and small increases left undetectable by visual classification Mammographic density is a strong risk factor for breast cancer ; however the mechanism that underlies this association is unclear . We hypothesized that measures of energy balance early in life and in adulthood may be associated with mammographic density . We conducted a cross-sectional analysis of 1,398 women in the Nurses ’ Health Study to examine associations between physical activity , childhood and current body fatness , weight gain from age 18 years to present and mammographic density . Percent mammographic density was measured from digitized mammograms by a computer-assisted method . Demographic and lifestyle data were obtained from prospect ively collected question naires . For all analyses , subjects were stratified into three groups : premenopausal women , postmenopausal women not currently taking hormones , and postmenopausal women currently taking hormones . Childhood body fatness was inversely associated with mammographic density . The correlations ranged from −0.15 to −0.19 in the three strata of women ( P ≤ 0.001 ) . The difference in mean percent mammographic density between the leanest and heaviest body types ranged from 6.2 to 9.9 % . Similarly , adult body fatness was inversely associated with percent mammographic density . The correlations ranged from −0.41 to −0.48 in the three strata of women ( P < 0.0001 ) . The difference in mean percent mammographic density between the leanest and heaviest body types ranged from 22.3 to 35.1 % . Weight gain from age 18 was also inversely associated with mammographic density . There was no association between recent physical activity and mammographic density . These findings indicate that childhood and adult body fatness and weight change from age 18 are inversely associated with mammographic density BACKGROUND The appearance of breast tissue on mammography varies according to its composition . Fat is radiolucent and appears dark on mammography , while stromal and epithelial tissue has greater optical density and appears light . Extensive areas of radiologically dense breast tissue seen on mammography are associated with an increased risk of breast cancer . PURPOSE The purpose of the present study was to determine whether the adoption of a low-fat , high-carbohydrate diet for 2 years would reduce breast density . METHODS Women with radiologic densities in more than 50 % of the breast area on mammography were recruited and r and omly allocated to an intervention group taught to reduce intake of dietary fat ( mean , 21 % of calories ) and increase complex carbohydrate ( mean , 61 % of calories ) or to a control group ( mean , 32 % of calories from fat and 50 % of calories from carbohydrates ) . Mammographic images from 817 subjects were taken at baseline and compared with those taken 2 years after r and om allocation by use of a quantitative image analysis system , without knowledge of the dietary group of the subjects or of the sequence in which pairs of images had been taken . The effects of the intervention on the mammographic features of breast area , area of dense tissues in the breast , and the percent of the breast occupied by dense tissue were examined using t tests . Multiple regression was used to examine these effects while accounting for age at trial entry , weight change , and menopausal status . RESULTS After 2 years , the total area of the breast was reduced by an average of 233.7 mm2 ( 2.4 % ) ( 95 % confidence interval [ CI ] = 106.9 - 360.6 ) in the intervention group compared with an average increase of 26.3 mm2 ( 0.3 % ) ( 95 % CI = -108.0 - 160.5 ) in the control group ( P = .01 ) . The area of density was reduced by 374.4 mm2 ( 6.1 % ) ( 95 % CI = 235.1 - 513.8 ) in the intervention group compared with an average of 127.7 mm2 ( 2.1 % ) ( 95 % CI = 8.6 - 246.7 ) in the control group ( P = .01 ) . Weight loss was associated with a reduction in breast area . The effect of the intervention on breast area was only marginally statistically significant after weight change , menopausal status , and age at trial entry were taken into account ( P = .06 ) . Greater weight loss and becoming postmenopausal were associated with statistically significant reductions in the area of density on the mammographic image at 2 years ( P = .04 and P<.001 , respectively ) . Age at entry into the trial was marginally significant in the same direction ( P = .06 ) . The effect of the intervention on area of density remained statistically significant after controlling for weight loss , age at entry , and menopausal status ( P = .03 ) . The change in the percentage of dense tissue in the mammographic image was not significantly different between the two groups ( P = .71 ) . CONCLUSIONS AND IMPLICATION S These results show that after 2 years , a low-fat , high-carbohydrate diet reduced the area of mammographic density , a radiographic feature of the breast that is a risk factor for breast cancer . Longer observation of a larger number of subjects will be required to determine whether these effects are associated with changes in risk of breast cancer OBJECTIVE To compare changes in mammographic density and the expression of markers of proliferation ( Ki67 ) and apoptosis ( Bcl-2 ) after 1 year of treatment with tibolone and continuous conjugated equine estrogens combined with medroxyprogesterone acetate ( CEE-MPA ) . DESIGN Comparative , r and omized , evaluator-blinded study . SETTING City research hospital . PATIENT(S ) Thirty-seven postmenopausal women . INTERVENTION(S ) Tibolone ( 2.5 mg ; n = 18 ) or continuous conjugated estrogens ( 0.625 mg ) combined with medroxyprogesterone acetate ( 5 mg ; n = 19 ) for 1 year . MAIN OUTCOME MEASURE(S ) Mammographic density ( BI-RADS density score ) , expression of immunohistochemical markers Ki67 and Bcl-2 . RESULT ( S ) Mean breast density score decreased significantly from 2.22 to 1.67 in the tibolone group , compared with a significant increase in the CEE-MPA-treated group from 1.84 to 2.63 . Ki67 expression decreased in 12 of 15 , increased in 2 of 15 , and remained unchanged in 1 of 15 subjects in the tibolone group , compared with 1 of 19 , 15 of 19 , and 3 of 19 subjects , respectively , in the CEE-MPA group . Bcl-2 expression decreased in 12 of 15 , increased in 2 of 15 , and remained unchanged in 1 of 15 subjects in the tibolone group , compared with 5 of 19 , 9 of 19 , and 5 of 19 subjects , respectively , in the CEE-MPA group . CONCLUSION ( S ) One-year treatment with tibolone induced a decrease in breast density , with a reduction in proliferation and a stimulation of apoptosis , whereas 1-year treatment with CEE-MPA induced an increase in breast density , with stimulation of proliferation and inhibition of apoptosis , indicating that tibolone effects on the breast are different from those of CEE-MPA Background : The relatively high dietary intake of soy in Asian countries has been hypothesized to , at least partly , explain the lower breast cancer incidence patterns in these countries compared with the Western world . The aim of the present study was to determine the effect of daily soy supplementation on mammographic density , one of the strongest known risk factors for breast cancer . Methods : A double-blind , r and omized , controlled trial was conducted to compare the effects of soy protein intake containing 99 mg isoflavones daily with intake of milk protein ( placebo ) for the duration of 1 year . Two hundred and two Dutch postmenopausal women ages 60 to 75 years were r and omized . Mammographic density was assessed using a quantitative computer-assisted method on digitized mammograms . Equol producer status was assessed in plasma provided at the final visit ( soy group ) or after a 3-day challenge with soy after the trial was finished ( placebo group ) . Results : A total of 175 women completed the baseline visits and at least one follow-up visit and were included in the intention-to-treat analyses . For 126 women , both pre- and post-trial mammograms were available . Mammographic density decreased in both study arms , but the decrease did not differ significantly between intervention and placebo groups . Equol producer status did not modify the results . Conclusion : The results of this trial do not support the hypothesis that a diet high in soy protein among postmenopausal women decreases mammographic density . ( Cancer Epidemiol Biomarkers Prev 2008;17(10):2632–8 BACKGROUND Although isoflavones , such as those found in soy , have been shown to inhibit breast cancer in laboratory studies , associations between consumption of isoflavone-containing foods and breast cancer risk have been inconsistent in epidemiologic studies . We evaluated the relationship between isoflavone consumption and breast cancer risk among women in the Japan Public Health Center-Based Prospect i ve Study on Cancer and Cardiovascular Diseases ( JPHC Study ) . METHODS In January 1990 , 21 852 Japanese female residents ( aged 40 - 59 years ) from four public health center areas completed a self-administered question naire , which included items about the frequency of soy consumption . Through December 1999 and 209 354 person-years of follow-up , 179 women were diagnosed with breast cancer . Cox proportional hazards regression was used to estimate the relative risks ( RRs ) and 95 % confidence intervals ( CIs ) for breast cancer in relation to consumption of miso soup , soyfoods , and estimated isoflavones . All statistical tests were two-sided . RESULTS Consumption of miso soup and isoflavones , but not of soyfoods , was inversely associated with the risk of breast cancer . The associations did not change substantially after adjustment for potential confounders , including reproductive history , family history , smoking , and other dietary factors . Compared with those in the lowest quartile of isoflavone intake , the adjusted RRs for breast cancer for women in the second , third , and highest quartiles were 0.76 ( 95 % CI = 0.47 to 1.2 ) , 0.90 ( 95 % CI = 0.56 to 1.5 ) , and 0.46 ( 95 % CI = 0.25 to 0.84 ) , respectively ( P(trend ) = .043 ) . The inverse association was stronger in postmenopausal women ( P(trend ) = .006 ) . CONCLUSION In a population -based , prospect i ve cohort study in Japan , frequent miso soup and isoflavone consumption was associated with a reduced risk of breast cancer Soy isoflavones have functional similarity to human estrogens and may protect against breast cancer as a result of their antiestrogenic activity or increase risk as a result of their estrogen-like properties . We examined the relation between isoflavone supplementation and mammographic density , a strong marker for breast cancer risk , among postmenopausal women . The Osteoporosis Prevention Using Soy ( OPUS ) study , a multi-site , r and omized , double-blinded , and placebo-controlled trial assigned 406 postmenopausal women to 80 or 120 mg/d of isoflavones each or a placebo for 2 y. Percent densities were assessed in digitized mammograms using a computer-assisted method . The mammogram reader did not know the treatment status and the time of mammograms . We applied mixed models to compare breast density by treatment while considering the repeated measures . The mammographic density analysis included 358 women , 88.2 % of the OPUS participants ; 303 had a complete set of 3 mammograms , 49 had 2 , and 6 had only 1 mammogram . At baseline , the groups were similar in age , BMI , and percent density , but mean breast density differed by study site ( P = 0.02 ) . A model with all mammograms did not show a treatment effect on any mammographic measure , but the change over time was significant ; breast density decreased by 1.6%/y across groups ( P < 0.001 ) . Stratification by age and BMI did not reveal any effects in subgroups . In this r and omized 2-y trial , isoflavone supplements did not modify breast density in postmenopausal women . These findings offer reassurance that isoflavones do not act like hormone replacement medication on breast density Physical activity has been associated with a reduced risk of breast cancer . However , little is known about the association between recreational physical activity and mammographic density . We examined the association between recreational physical activity and mammographic density using mammograms from 375 white and African American women without breast cancer who served as controls in the Los Angeles component of the Women 's Contraceptive and Reproductive Experiences Study . We used data from 5 time periods of activity in the statistical analysis : from menarche to mammogram screening , the first 3 and 10 years after menarche , the most recent 10 years and the 3 years prior to mammogram screening . Lifetime history of recreational physical activity was obtained through interviews using a structured question naire . We used multiple linear regression to estimate least-squared mean values of absolute and percent mammographic density within categories of physical activity . Overall , we found no statistically significant evidence that physical activity reduced absolute or percent mammographic density . We observed a modest positive association between lifetime physical activity and percent mammographic density ( p for trend = 0.04 ) among younger women , and between recent physical activity and percent density among both younger ( < 50 years , p for trend = 0.09 ) and older ( > or = 50 years , p for trend = 0.06 ) women , but these associations diminished after additionally adjusting for body mass index ( BMI ) ( all p > or = 0.10 ) . However , among women younger than 50 years , we found some evidence for a protective effect of " strenuous " physical activity in the first 3 years after menarche , with a nonstatistically significant inverse association with both absolute ( p for trend = 0.07 ) and percent ( p for trend = 0.08 ) mammographic density after adjustment for BMI . Our results suggest that physical activity is not a strong predictor of mammographic density To examine the effects of dietary fat intake on breast cancer risk , we are conducting a r and omized trial of dietary intervention in women with extensive areas of radiologically dense breast tissue on mammography , a risk factor for breast cancer . Early results show that after 2 years on a low-fat , high-carbohydrate diet there is a significant reduction in area of density , particularly in women going through menopause . In women who went through menopause during the 2-year follow-up , the mean decreases in area of density and percentage of density in the intervention group were 11.0 cm2 and 11.0 % , respectively , whereas the control group decreased 4.5 cm2 and 5.2 % . The purpose of this analysis was to determine whether changes in intake of specific macronutrients could account for the observed reduction in breast density in these women . Differences between 2-year and baseline values of macronutrients ( averaged over 3 nonconsecutive days of food intake ) were calculated . We examined the effect of dietary variables , adjusted for changes in total calorie intake and weight and for family history of breast cancer , on changes in area of density and percentage of density using linear regression . Reduction in total or saturated fat intake or cholesterol intake was significantly associated with decreased dense area ( p < or = .004 ) . The most significant dietary variable associated with reduction in percentage of density was reduction in dietary cholesterol intake ( P = 0.001 ) , although reducing saturated fat intake was of borderline significance ( P = 0.05 ) . The effect of the membership in the intervention and control groups on change in area of density or percentage of density was reduced by models that included changes in intake of any fat , or cholesterol , or carbohydrates . The observation of an effect of diet at menopause on breast density , a marker of increased risk of breast cancer , may be an indication that exposures at this time have an enhanced effect on subsequent risk Background : The Alberta Physical Activity and Breast Cancer Prevention ( ALPHA ) Trial examined the influence of aerobic exercise on biological factors that are associated with breast cancer risk . Mammographic density , a secondary outcome , is reported here . Methods : The ALPHA Trial was a parallel group r and omized controlled trial conducted between May 2003 and July 2007 . Postmenopausal , sedentary women ages 50 to 74 years ( n = 320 ) were evenly r and omized to aerobic exercise ( 45 minutes , 5 days per week ) or control ( usual life-style ) for 1 year . Dense fibrogl and ular tissue and nondense fatty tissue were measured from mammograms at baseline and 1 year using computer-assisted thresholding software for area measurements and a new technique that relies on the calibration of mammography units with a tissue-equivalent phantom for volumetric measurements . Results : Nondense volume decreased in the exercise group relative to the control group ( difference between groups = −38.5 cm3 ; 95 % confidence interval , −61.6 to 15.4 ; P = 0.001 ) . Changes in total body fat accounted for this decrease . Changes in dense area and dense volume , measures that have previously been associated with breast cancer risk , were not significantly different between the groups ( P ≥ 0.26 ) . Conclusions : Achieving changes in mammographic measures may require more exercise or a study population with higher baseline levels of sex hormones or a wider range of mammographic density . The data from this study , however , suggest that the protective effect of exercise on breast cancer risk may operate through a mechanism other than mammographic density . Cancer Epidemiol Biomarkers Prev ; 19(4 ) ; 1112–21 . © 2010 AACR High mammographic breast density is one of the strongest intermediate markers of breast cancer risk , and decreases in density over time have been associated with decreases in breast cancer risk . Using repeated measures of mammographic density in a cohort of high-risk women , the Women at Risk ( WAR ) cohort at Columbia University Medical Center ( N = 2670 ) , we examined whether changes in prediagnostic mammographic density differed among 85 prospect ively-ascertained breast cancer cases and 85 age-matched controls , using a nested case – control design . Median age at first mammogram was 51 years ( range , 29–77 years ) , with a median of 4 years between first and second prediagnostic mammogram ( range , 1–15 years ) . Using linear regression with change in percent density as the outcome , we found that in women who did not go on to be diagnosed with breast cancer , change in percent density decreased as time between first and second mammogram increased ( β = −1.62 % per year , p = 0.004 ) . However , in women who did go on to be diagnosed with breast cancer , there was no overall change in percent density associated with time between first and second mammogram ( β = 0.29 % per year , p = 0.61 ) ; the change over time was statistically significantly different between cases versus controls ( p < 0.009 ) . If replicated in larger cohorts , these results suggest that within-individual changes in mammographic density as measured by percent density may be a useful biomarker of breast cancer risk Objectives To examine the role of energy intake and dietary patterns in childhood and throughout adulthood on subsequent mammographic density . Methods Prospect i ve data were available from a cohort of 1161 British women followed up since their birth in 1946 . Dietary intakes at age 4 years were determined by 24-hour recalls and during adulthood , average food consumed at ages 36 and 43 years by 5-day food records . Dietary patterns were determined by factor analysis . Associations between energy intake , dietary patterns , and percent breast density were investigated using regression analysis . Results During adulthood , energy intake was positively associated with percent breast density ( adjusted regression coefficient [ per SD ) ( 95 % CI ) : 0.12 ( 0.01 , 0.23 ) ] . The effect of the high fat and sugar dietary pattern remained similar when adjusted for total energy intake [ 0.06 ( −0.01 , 0.13 ) ] . There was no evidence of an associations for the patterns low fat , high fiber pattern 0.03 ( −0.04 , 0.11 ) ; the alcohol and fish −0.02 ( −0.13 , 0.17 ) ; meat , potatoes , and vegetables −0.03 ( −0.10 , 0.04 ) . No association was found for dietary pattern at age 4 and percent breast density . Conclusions This study supports the hypothesis that overall energy intake during middle life is a determinant of subsequent mammographic breast density measured 15 years later BACKGROUND Although mammographic breast density is associated with the risk of breast cancer and is influenced by hormone levels , the effects of tamoxifen on breast density in healthy women and whether tamoxifen-induced density changes are associated with breast cancer risk are unclear . We investigated mammographic breast density in healthy women with an increased risk of breast cancer at baseline and during 54 months of tamoxifen treatment . METHODS Mammograms were review ed from 818 breast cancer-free women ( 388 in the tamoxifen group and 430 in the placebo group ) at high risk for breast cancer , from the International Breast Cancer Intervention Study I , a trial of tamoxifen for breast cancer prevention . Breast density measurements , at baseline and during treatment , were obtained at 12- to 18-month intervals . Multivariable analysis was used to assess associations with breast density . All statistical tests were two-sided . RESULTS Breast density at baseline was similar in placebo ( 42.6 % , 95 % confidence interval [ CI ] = 39.6 % to 45.6 % ) and tamoxifen ( 41.9 % , 95 % CI = 38.8 % to 45.0 % ) groups . The main determinants of breast density at baseline were age , menopausal status , body mass index , and previous atypical hyperplasia . A greater density reduction in the tamoxifen group ( 7.9 % , 95 % CI = 6.9 % to 8.9 % ) than in the placebo group ( 3.5 % , 95 % CI = 2.7 % to 4.3 % ) was apparent within 18 months of treatment ( P<.001 ) ; the reduction in density continued until 54 months of treatment . After 54 months of tamoxifen treatment , breast density was 28.2 % ( decrease from baseline = 13.7 % , 95 % CI = 12.3 % to 15.1 % ; P<.001 ) in the tamoxifen group and 35.3 % ( decrease from baseline = 7.3 % , 95 % CI = 6.1 % to 8.4 % ; P<.001 ) in the placebo group . The tamoxifen-associated density reduction was apparent in all subgroups , but there was a statistically significant interaction with age . In women aged 45 years or younger at entry , the net reduction with tamoxifen was 13.4 % ( 95 % CI = 8.6 % to 18.1 % ) , whereas in women older than 55 years , it was 1.1 % ( 95 % CI = -3.0 % to 5.1 % ) . CONCLUSION Tamoxifen treatment was associated with reduction in breast density , most of which occurred during the first 18 months of treatment Background : Change in breast density may predict outcome of women receiving adjuvant hormone therapy for breast cancer . We performed a prospect i ve clinical trial to evaluate the impact of inherited variants in genes involved in oestrogen metabolism and signalling on change in mammographic percent density ( MPD ) with aromatase inhibitor ( AI ) therapy . Methods : Postmenopausal women with breast cancer who were initiating adjuvant AI therapy were enrolled onto a multicentre , r and omised clinical trial of exemestane vs letrozole , design ed to identify associations between AI-induced change in MPD and single-nucleotide polymorphisms in c and i date genes . Subjects underwent unilateral craniocaudal mammography before and following 24 months of treatment . Results : Of the 503 enrolled subjects , 259 had both paired mammograms at baseline and following 24 months of treatment and evaluable DNA . We observed a statistically significant decrease in mean MPD from 17.1 to 15.1 % ( P<0.001 ) , more pronounced in women with baseline MPD ⩾20 % . No AI-specific difference in change in MPD was identified . No significant associations between change in MPD and inherited genetic variants were observed . Conclusion : Subjects with higher baseline MPD had a greater average decrease in MPD with AI therapy . There does not appear to be a substantial effect of inherited variants in biologically selected c and i date genes BACKGROUND Tamoxifen or raloxifen for 5 years reduces the risk of developing invasive breast cancer by 40 % . To address safety concerns and seek enhanced efficacy , studies of new chemopreventive agents using mammographic density as a surrogate end point are attractive . PATIENTS AND METHODS Postmenopausal women with risk factors for developing breast cancer were given letrozole 2.5 mg daily for one year , and mammographic density was the biomarker of breast cancer risk modification . It was assessed ( blinded to the reader ) at baseline , 6 , and 12 months in 16 evaluable women among 20 enrolled . RESULTS Eight patients exhibited decreased mammographic density at six months , and eleven at 12 months . Toxicities included joint aches not precluding continued treatment . CONCLUSION This pilot study supports the use of letrozole for reducing breast cancer risk . In addition , it encourages prospect i ve studies of serial changes in mammographic density as a biomarker of risk modification within a selected high-risk population A protective effect of physical activity ( PA ) on breast cancer ( BC ) risk has been suggested . Few studies have examined the influence of PA on mammographic breast density ( MBD ) , a strong risk factor for BC . In a prospect i ve study in Florence , Italy , we identified 2,000 healthy women with a mammogram taken 5 years after enrollment . Individual mammograms were retrieved ( 83 % ) and MBD assessed according to Wolfe 's classification . Detailed information on PA at work and during leisure time , reproductive history , lifestyle and anthropometric measurements at enrollment were available for 1,666 women . Information on hormone replacement therapy ( HRT ) was also obtained at mammogram . Women with high-MBD ( P2 + DY Wolfe 's patterns ) were compared with women with low-MBD ( N1 + P1 ) by multivariate logistic models . Overall , high-MBD was inversely associated with increasing levels of leisure time PA ( p for trend = 0.04 ) and among peri-/postmenopausal women , also with increasing levels of recreational activities ( p for trend = 0.02 ) . An interaction between PA and HRT emerged , with a stronger inverse association of highest level of recreational activity with MBD among HRT nonusers ( p for interaction = 0.02 ) . A modifying effect by body mass index ( BMI ) was evident among 1,025 peri-/postmenopausal women who did not use HRT at the time of mammogram , with a stronger inverse association between recreational PA and MBD in the highest BMI tertile ( OR = 0.34 ; 95 % CI 0.20 - 0.57 ; p for interaction = 0.03 ) . This large study carried out in Mediterranean women suggests that leisure time PA may play a role in modulating MBD , particularly in overweight/obese peri-/postmenopausal women Objective Breast density is associated with an increased risk of breast cancer . This study assessed changes in mammographic breast density after 24 months of treatment with bazedoxifene (BZA)/conjugated estrogens ( CE ) in postmenopausal women . Methods This was an ancillary study in a subset of nonhysterectomized postmenopausal women enrolled in a r and omized , double-blind , placebo-controlled , and active-controlled phase 3 study . Treatments evaluated were BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , raloxifene 60 mg , and placebo . Women who were eligible for participation in the ancillary study must have completed 24 months of treatment and have mammograms at baseline and 24 months . The left craniocaudal views from each mammogram pair were digitized and analyzed by a radiologist who was blinded to treatment arm and mammogram date . The percent breast density was determined using vali date d software . Results Mammogram pairs were obtained from 507 evaluable participants ( mean age range , 55.2 - 56.3 y ) . The mean changes ( 95 % CI ) in mammographic breast density from baseline to 24 months were comparable among groups ( −0.39 % [ −0.69 to −0.08 ] , −0.05 % [ −0.38 to 0.27 ] , −0.23 % [ −0.54 to 0.08 ] , and −0.42 % [ −0.72 to −0.11 ] for BZA 20 mg/CE 0.45 mg , BZA 20 mg/CE 0.625 mg , raloxifene 60 mg , and placebo , respectively ) . These reductions from baseline were statistically significant for BZA 20 mg/CE 0.45 mg and placebo . The effect of both BZA/CE doses on breast density was generally consistent among subgroups based on age , body mass index , and years since menopause . Conclusions Treatment with BZA 20 mg/CE 0.45 mg or BZA 20 mg/CE 0.625 mg for 24 months did not affect mammographic breast density in this population of postmenopausal women Objective : This study aim ed to assess quantitative changes in mammographic breast density after 24 months of therapy with bazedoxifene compared with raloxifene or placebo in postmenopausal women with osteoporosis . Methods : This was a retrospective , ancillary study of a subset of women enrolled in a multicenter , double-blind , r and omized , placebo- and active-controlled phase 3 trial evaluating bazedoxifene for the treatment of postmenopausal osteoporosis . Participants were r and omly assigned to receive bazedoxifene 20 or 40 mg , raloxifene 60 mg , or placebo once daily for 3 years . To be eligible for breast density evaluation , participants had to be 62 years or younger and completed 24 months of treatment , with mammograms at baseline and 24 months . Original mammogram pairs ( left craniocaudal views ) for each participant were digitized and analyzed by a radiologist . Breast density was measured using interactive thresholding to segment the mammogram , and percent density was determined using a vali date d software program . Results : Mammogram pairs were obtained from 444 participants . Baseline and demographic characteristics were similar among groups ( mean age , 58.7 y ) . After 24 months , the mean percent changes in breast density from baseline were low ( bazedoxifene 20 mg , −1.2 % ; bazedoxifene 40 mg , −0.4 % ; raloxifene 60 mg , −0.5 % ; placebo , −0.2 % ) and not significantly different among groups . Conclusions : Treatment with bazedoxifene for 2 years did not affect age-related changes in breast density in this population of postmenopausal women with osteoporosis . The changes in breast density with bazedoxifene 20 or 40 mg were similar to those with raloxifene 60 mg or placebo BACKGROUND High mammographic density is associated with increased breast cancer risk . Previous studies have shown that estrogens increase breast density on mammograms , but the effect on mammographic density of selective estrogen receptor modulators , such as raloxifene , is unknown . We assessed changes in mammographic density among women receiving placebo , raloxifene , or conjugated equine estrogens in an osteoporosis prevention trial . METHODS In a 5-year multicenter , double-blind , r and omized , placebo-controlled osteoporosis prevention trial , healthy postmenopausal women who had undergone hysterectomy less than 15 years before the study and had no history of breast cancer received placebo , raloxifene ( at one of two doses ) , or conjugated estrogens ( ERT ) . Women from English-speaking investigative sites who had baseline and 2-year craniocaudal mammograms with comparable positioning ( n = 168 ) were eligible for this analysis . Changes in mammographic density were determined by digital scanning and computer-assisted segmentation of mammograms and were analyzed with the use of analysis of variance . All statistical tests were two-sided . RESULTS Among the four treatment groups after 2 years on study , the mean breast density ( craniocaudal view ) was statistically significantly greater in the ERT group than it was in the other three groups ( P<0.01 for all three comparisons ) . Within treatment groups , the mean breast density from baseline to 2 years decreased statistically significantly in women receiving the placebo or either the higher or lower raloxifene dose ( P = 0.003 , P = 0.002 , and P<0.001 , respectively ) and showed a nonstatistically significant increase in women receiving ERT . CONCLUSIONS In an osteoporosis prevention trial , raloxifene did not increase breast density after 2 years of treatment . Raloxifene administration should not interfere with , and could even enhance , mammographic detection of new breast cancers The estrogenic and antiestrogenic effects of isoflavones , phytoestrogens contained in soy foods , have been proposed as mechanisms for the possible involvement of soy products in the development of breast cancer . We investigated the hypothesis that isoflavones reduce mammographic density , a predictor of breast cancer risk . We conducted a double-blind r and omized trial in premenopausal women who received a daily 100 mg isoflavone supplement or a placebo over 12 months . Compliance with the study regimen was confirmed by urinary isoflavones and tablet counts . We used a computer-assisted method to measure mammographic density and paired t-tests to assess changes in mammographic characteristics from baseline to follow-up mammogram . Complete sets of mammograms were available for 30 women . The two groups differed by age and mammographic density at baseline , but were similar in body weight and nutritional intakes . We detected no significant changes either in the size of the dense areas or in the per cent densities . A non-significant decrease in breast area among intervention group subjects was probably the result of method ological issues in comparing mammograms taken under different conditions . In conclusion , our findings do not support the hypothesis that isoflavones decrease mammographic density during a one-year intervention . Although this exploratory study had limited power , it appears that isoflavones do not exert an estrogenic effect similar to hormone replacement therapy on mammographic density Physical inactivity and high mammographic breast density have both been associated with increased breast cancer risk . However , the association between physical activity and mammographic breast density remains inconsistent . In the European Prospect i ve Investigation of Cancer (EPIC)-Norfolk population -based cohort study ( United Kingdom ) , the authors investigated the cross-sectional association between physical activity level at baseline during 1993 - 1997 and breast density among 1,394 postmenopausal , cancer-free women . Usual physical activity was assessed by a brief , vali date d question naire . Percentage breast density was determined visually from mammograms by three trained radiologists using the Boyd six-category scale . The association between physical activity level and breast density risk category was examined . No statistically significant association between physical activity and percentage breast density was observed in the unadjusted or adjusted regression models . A suggested increase in breast density for the most active women in the unadjusted regression analysis ( odds ratio = 1.13 , 95 % confidence interval : 0.71 , 1.80 ) was reversed after inclusion of body mass index and reproductive and lifestyle variables ( odds ratio = 0.78 , 95 % confidence interval : 0.45 , 1.34 ) . The lack of an association between physical activity and percentage breast density suggests that an association between physical activity and breast cancer risk is unlikely to be mediated through an effect on mammographic breast density The objective of this study was to determine if 6 months of the aromatase inhibitor letrozole , administered to postmenopausal women taking a stable dose of hormone replacement remedy , would be safe and would modulate biomarkers of breast cancer risk . The intent was to reduce the proliferation marker Ki-67 while maintaining adequate systemic levels of estradiol so as to avoid perimenopausal symptoms . Postmenopausal women at high risk for development of breast cancer and taking a stable dose of estrogen or estrogen plus progestin were screened by r and om periareolar fine needle aspiration ( RPFNA ) . To be eligible , the acquired breast epithelial cells had to be characterized as cytologic atypia or borderline atypia with ≥1,000 epithelial cells on the cytomorphology slide ; plus ≥500 epithelial cells on a slide processed for Ki-67 immunocytochemistry . Forty-two women were enrolled in the one arm study and received 2.5 mg letrozole per day for 6 months , followed by repeat assessment of biomarkers . Ki-67 was reduced by a median relative value of 66 % . There was no significant change in breast cell cytomorphology ; ER weighted index score ; serum estradiol , testosterone , or IGF-1:IGFBP-3 ratio ; mammographic breast density , or frequency or severity of perimenopausal symptoms . Given the dramatic reduction in proliferation , the effect of letrozole on risk and response biomarkers should be explored further in a r and omized , placebo-controlled Phase IIB breast cancer chemoprevention trial Factors associated with an increased risk of breast cancer include prior breast cancer , high circulating estrogens , and increased breast density . Adjuvant aromatase inhibitors are associated with a reduction in incidence of contralateral breast cancer . We conducted a prospect i ve , single-arm , single-institution study to determine whether use of anastrozole is associated with changes in contralateral breast density and circulating estrogens . Eligible patients included postmenopausal women with hormone receptor-positive early-stage breast cancer who had completed local therapy , had an intact contralateral breast , and were recommended an aromatase inhibitor as their only systemic therapy . Participants received anastrozole 1 mg daily for 12 months on study . We assessed contralateral breast density and serum estrogens at baseline , 6 , and 12 months . The primary endpoint was change in contralateral percent breast density from baseline to 12 months . Secondary endpoints included change in serum estrone sulfate from baseline to 12 months . Fifty-four patients were accrued . At 12 months , compared with baseline , there was a nonstatistically significant reduction in breast density ( mean change : −16 % , 95 % CI : −30 to 2 , P = 0.08 ) and a significant reduction in estrone sulfate ( mean change : −93 % , 95 % CI : −94 to −91 , P < 0.001 ) . Eighteen women achieved 20 % or greater relative reduction in contralateral percent density at 12 months compared with baseline ; however , no measured patient or disease characteristics distinguished these women from the overall population . Large trials are required to provide additional data on the relationship between aromatase inhibitors and breast density and , more importantly , whether observed changes in breast density correlate with meaningful disease-specific outcomes . Cancer Prev Res ; 4(12 ) ; 1993–2001 . © 2011 AACR Background : Evidence accumulates that physical inactivity is one of the few modifiable risk factors for breast cancer . The mechanism through which physical inactivity affects breast cancer risk is not clear . The study aim was to investigate the association between physical activity and breast density because mammographic density is strongly associated with breast cancer risk . Methods : We did a cross-sectional study in 620 women , of ages 49 to 68 years and participants of the Dutch Prospect -European Prospect i ve Investigation into Cancer and Nutrition cohort . A self-administered question naire was used to obtain information on duration and intensity of physical activity ( recreational , household , and occupational ) during the year preceding study recruitment . A total activity index ( inactive , moderately inactive , moderately active , and active ) was estimated by combining all activity types . Percent and absolute breast density were determined on screening mammograms using a computer-aided method . Multivariate linear regression was used to examine the association between physical activity and breast density . Results : Mean percent density was 35.3 % [ 95 % confidence interval ( 95 % CI ) , 31.8 - 38.8 ] for the inactive category compared with 36.1 % ( 95 % CI , 33.0 - 39.2 ) for the active category . Mean absolute density values for the inactive and active category were 45.8 cm2 ( 95 % CI , 40.9 - 50.7 ) and 42.6 cm2 ( 95 % CI , 38.3 - 47.0 ) , respectively . Subgroup analysis for postmenopausal women showed similar results , as did separate analyses for recreational and household activity . Conclusions : The result does not support a relation between current physical activity and mammographic density in postmenopausal women . ( Cancer Epidemiol Biomarkers Prev 2006;15(3):456–60 OBJECTIVE Our purpose was to compare the effects of tibolone , continuous combined hormone replacement therapy , and placebo on mammographic breast density . STUDY DESIGN A prospect i ve , r and omized , double-blind placebo-controlled study was performed . A total of 166 postmenopausal women were equally r and omized to receive tibolone 2.5 mg , estradiol 2 mg/norethisterone acetate 1 mg ( E(2)/NETA ) , or placebo . Mammograms were performed at baseline and after 6 months of treatment . Mammographic density was quantified according to the Wolfe classification and by the percentage area of the breast that had a dense pattern . RESULTS An increase in mammographic density was much more common among women receiving continuous combined hormone replacement therapy ( 46%-50 % ) than among those receiving tibolone ( 2%-6 % ) and placebo ( 0 % ) treatment . The difference between E(2)/NETA and placebo was highly significant ( P < .001 ) . Treatment with tibolone did not differ from that with placebo . The relative risk of an increase in breast density for E(2)/NETA versus tibolone was found to be 8.3 ( 95 % CI 2.7 - 25.0 ) . CONCLUSION An increase in mammographic density should be regarded as an unwanted side effect of hormone replacement therapy . In contrast to estrogen/progestogen treatment , tibolone seems to exert little stimulation of breast tissue There are strong data showing that increased breast cancer risk is associated with increased mammographic density . Tamoxifen has been shown to decrease the risk of invasive breast cancer and decrease breast density . We sought to demonstrate and calculate the extent of change in mammographic density in women who have taken tamoxifen for up to 2 years . We evaluated mammograms from 28 high-risk women who were taking tamoxifen . Four different methods of evaluation were used : ( a ) two qualitative methods ( Wolfe criteria and the American College of Radiology Breast Imaging and Reporting Data System criteria ) ; ( b ) one semiquantitative method ( mammograms were assigned one of five semiquantitative scores by visual inspection ) ; and ( c ) one quantitative method ( computer-aided calculation of fibrogl and ular area from digitized mammograms ) . The Wolfe criteria showed a 0.03 category decrease per year ( P = 0.50 ) . The American College of Radiology Breast Imaging and Reporting Data System criteria showed a 0.1 category decrease per year ( P = 0.12 ) . Semiquantitative criteria showed a 0.2 category decrease per year ( P = 0.039 ) . Digitized scores showed a 4.3 % decrease per year ( P = 0.0007 ) . In conclusion , tamoxifen causes a decrease in mammographic density with use , an effect that is better quantitated with semiquantitative criteria or digitized images . Density change might become useful as a surrogate end point for the effect of tamoxifen and other chemopreventive measures , although our data do not predict an individual 's degree of risk reduction Objective The prolonged use of estrogen therapy is associated with a slightly increased risk of breast cancer . Alternative therapies that are effective in the prevention of menopause , having associated morbidities but no unwanted effects , are of primary interest in the pharmacologic research . The aim of this study was to evaluate the effect of two alternative to estrogens drugs , the selective estrogen receptor modulator raloxifene and the tissue-specific tibolone , on the mammographic appearance of the breast . Design The study group comprised 131 postmenopausal women aged 41 to 67 years . The women were at least 2 years postmenopausal , free of climacteric symptoms , and at the time of entry to the study had not had therapy for at least 9 months . Women with risk factors for osteoporosis or cardiovascular disease were allocated either to tibolone ( n = 56 ) or raloxifene ( n = 48 ) therapy . Women with no risk factors and women who either did not qualify for or denied treatment ( n = 27 ) served as controls . The study duration was 12 months . Women received a baseline mammogram before commencing therapy and a repeat mammogram at the end of the study period . Mammogram findings were classified according to the modified Wolfe criteria by two expert radiologists . Results No difference was identified between groups with respect to baseline characteristics associated with breast cancer risk . Similarly , no difference was detected between groups concerning the modified Wolfe classification of baseline mammographic findings . In the tibolone group , 10.7 % of the women showed an increase in breast density in the 12-month reevaluation . The respective figure in the raloxifene group was 6.3 % , whereas no woman in the control group showed an increase in breast density . Differences in the increase in breast density between groups did not , however , reach statistical significance . Accordingly , 10.7 % of women in the tibolone group and 18.8 % of women in the raloxifene group exhibited involutionary changes in the repeat mammogram , whereas 25.9 % of women in the control group revealed a decrease in breast density in the 12-month examination . The percentages were not significantly different between groups . Conclusions Breast density as shown by mammography was stable in a majority of patients and changed in a minority of cases for both tibolone and raloxifene . In most patients , these drugs are not likely to interfere with mammogram interpretation . Larger long-term studies are needed to confirm the impact of prolonged tibolone or raloxifene administration on mammography Objective : Dietary intake of vitamin D and calcium may be related to risk of breast cancer , possibly by affecting mammographic density . However , the few studies that have evaluated the association between these nutrients and mammographic density in postmenopausal women have had inconsistent results . Methods : We conducted a cross-sectional analysis in 808 participants of the Mammogram Density Ancillary Study of the Women 's Health Initiative . Mammographic percent density was measured using baseline mammograms taken before r and omization of participants in the intervention trials . Vitamin D and calcium intake was assessed with a vali date d food frequency question naire and an inventory of current supplement use , both completed at baseline . Results : After adjustment for age , body mass index , regional solar irradiance , and other factors , we did not find a relationship between vitamin D or calcium intake and mammographic density . Mean mammographic percent densities in women reporting total vitamin D intakes of less than 100 , 100 to 199 , 200 to 399 , 400 to 599 , and 600 or greater IU/day were 5.8 % , 10.4 % , 6.2 % , 3.8 % , and 5.1 % , respectively ( P trend = 0.67 ) . Results in women reporting a total calcium intake of less than 500 , 500 to 749 , 750 to 999 , 1,000 to 1,199 , and 1,200 or greater mg/day were 7.3 % , 4.9 % , 7.3 % , 6.9 % , and 7.11 % , respectively ( P trend = 0.51 ) . We did not observe any effect modification by overall level of mammographic density or solar irradiance , but supplemental vitamin D use was associated with lower density in younger women ( P interaction = 0.009 ) . Conclusions : These findings do not support a relationship between dietary vitamin D or calcium intake and mammographic density in postmenopausal women . Additional studies should explore these associations in women of different ages and in relation to serum vitamin D levels Mammographic density ( MD ) , or the proportion of the breast with respect to its overall area that is composed of dense tissue , is a strong risk factor for breast cancer . Studies support a positive association of mammographic density and alcohol drinking . This was a cross-sectional multicenter study based on 3584 women , aged 45–68 years , recruited from seven screening centers within the Spanish breast cancer screening program network . The association between MD , alcohol consumption and tobacco use was evaluated by using ordinal logistic models with r and om center-specific intercepts . We found a weak positive association between current alcohol intake and higher MD , with current alcohol consumption increasing the odds of high MD by 13 % ( OR = 1.13 ; 95 % CI 0.99–1.28 ) and high daily grams of alcohol being positively associated with increased MD ( P for trend = 0.045 ) . There were no statistically significant differences in MD between smokers and non-smokers . Nevertheless , increased number of daily cigarettes and increased number of accumulated lifetime cigarettes were negatively associated with high MD ( P for trend 0.017 and 0.021 ) . The effect of alcohol on MD was modified by menopausal status and tobacco smoking : whereas , alcohol consumption and daily grams of alcohol were positively associated with higher MD in postmenopausal women and in women who were not currently smoking , alcohol consumption had no effect on MD in premenopausal women and current smokers . Our results support an association between recent alcohol consumption and high MD , characterized by a modest increase in risk at low levels of current consumption and a decrease in risk among heavier drinkers . Our study also shows how the effects of alcohol in the breast can be modified by other factors , such as smoking The extent of breast tissue density on mammograms is one of the strongest risk factors for breast cancer . The aim of this analysis was to evaluate whether tamoxifen can affect mammographic breast density . Subjects were participants in the National Surgical Adjuvant Breast Project Breast Cancer Prevention Trial ( BCPT ) , recruited and followed at the Breast Center of Saint-Sacrement Hospital in Quebec City , Canada . The Breast Cancer Prevention Trial is a double-blind trial in which women at high risk of breast cancer were r and omized to receive either 20 mg tamoxifen per day or placebo . Mammograms were taken before treatment began and yearly thereafter . For the purpose of this analysis , Wolfe 's parenchymal pattern and the percentage of the breast showing tissue densities were assessed by review of pre- and posttreatment mammograms without knowledge of treatment assignment . Among the 69 women included in this analysis , 36 received tamoxifen and 33 received placebo for an average of 3.3 and 3.5 years , respectively . Among women receiving tamoxifen , 16 of 36 ( 44.4 % ) changed to a parenchymal pattern of lower density compared with 5 of 33 ( 15.2 % ) women receiving placebo ( P = 0.010 ) . Moreover , in the tamoxifen-treated group , the difference in the percentage of the breast showing tissue densities between the pre- and posttreatment mammograms reached -9.4 % on average compared with a reduction of -3.6 % in the placebo group ( P = 0.010 ) . Our data show that tamoxifen can reduce high-risk mammographic features . Breast densities should be evaluated as possible early markers of the preventive effect of selective estrogen receptor modulators Breast density , a strong risk factor for breast cancer , is reduced by the anti-estrogen , tamoxifen ( TAM ) . We examined whether aromatase inhibitor ( AI ) therapy results in further reductions in breast density among women completing 5 years of TAM . Among a sample of women with early-onset breast cancer who were r and omized to letrozole (LET)(n=56 ) or placebo (PLAC)(n=48 ) after 5 years of TAM , we examine the change in percent density at 9 - 15 months as well as a per-year change in PD by treatment group . There was no difference in the adjusted mean change ( -1.0 % , LET ; -0.3 % , PLAC ( P=0.58 ) ) or the percentage change ( -2.7 % , LET ; -3.0 % , PLAC ( P=0.96 ) ) in PD between treatment groups at 9 - 15 months . Results were similar for longitudinal change ( -0.68 % per year , LET ; -0.12 % per year , PLAC ( P=0.23 ) ) . Breast density does not appear to be a clinical ly relevant biomarker in women who already have low PD following 5 years of TAM Objective : The aim of this study was to investigate whether transdermal low-dose estradiol treatment induces changes in mammographic density or heterogeneity compared with raloxifene , whether if these changes relate to changes in bone formation/resorption markers , and whether these findings indicate elevation of breast cancer risk by treatment . Methods : Digitized mammograms of 2 × 135 completers of a 2-year , r and omized trial formed the base of the present analysis . Active treatments were transdermal estradiol releasing 0.014 mg estradiol (E2)/week and orally administered raloxifene hydrochloride 60 mg/day , respectively . Influence of the therapies on breast density was assessed with categorical scores Breast Imaging Reporting and Data System , area percentage density , and computer-based ( E2-specific ) heterogeneity examination of radiographs . These where related to physical and systemic markers . Results : At baseline , no mammography scoring methodology or other marker could separate the two treatment groups of transdermal estradiol and raloxifene . No treatment induced significant density changes measured by Breast Imaging Reporting and Data System . Both treatments made the area percentage density increase and the estradiol significantly . Both treatments induced significant changes in E2-specific heterogeneity scoring ( E2-specific heterogeneity examination of radiograph ) , and the raloxifene treatment induced a significantly higher change . At baseline , the mammographic markers showed negative correlation with body mass index and positive correlation with serum type I collagen crosslinks C-telopeptide . The changes in mammographic markers did not essentially exhibit correlations to changes in bone markers in either treatment group . Conclusions : Low-dose transdermal estradiol and raloxifene induced comparable changes in breast density and heterogeneity . Baseline correlations may be explained through relations to obesity . The current study does not yield evidence against the hypothesis that " neither raloxifene nor low dose transdermal estradiol treatment increases the breast cancer risk . PURPOSE Tamoxifen and fenretinide are active in reducing premenopausal breast cancer risk and work synergistically in pre clinical models . The authors assessed their combination in a two-by-two biomarker trial . PATIENTS AND METHODS A total of 235 premenopausal women with pT1mic/pT1a breast cancer ( n = 21 ) , or intraepithelial neoplasia ( IEN , n = 160 ) , or 5-year Gail risk > or = 1.3 % ( n = 54 ) were r and omly allocated to either tamoxifen 5 mg/d , fenretinide 200 mg/d , their combination , or placebo . We report data for plasma insulin-like growth factor I ( IGF-I ) , mammographic density , uterine effects , and breast neoplastic events after 5.5 years . RESULTS During the 2-year intervention , tamoxifen significantly lowered IGF-I and mammographic density by 12 % and 20 % , respectively , fenretinide by 4 % and 10 % ( not significantly ) , their combination by 20 % and 22 % , with no evidence for a synergistic interaction . Tamoxifen increased endometrial thickness principally in women becoming postmenopausal , whereas fenretinide decreased endometrial thickness significantly . The annual rate of breast neoplasms ( n = 48 ) was 3.5 % + /- 1.0 % , 2.1 % + /- 0.8 % , 4.7 % + /- 1.3 % , and 5.2 % + /- 1.3 % in the tamoxifen , fenretinide , combination , and placebo arms , respectively , with hazard ratios ( HRs ) of 0.70 ( 95 % CI , 0.32 to 1.52 ) , 0.38 ( 95 % CI , 0.15 to 0.90 ) , and 0.96 ( 95 % CI , 0.46 to 1.99 ) relative to placebo ( tamoxifen x fenretinide adverse interaction P = .03 ) . There was no clear association with tumor receptor type . Baseline IGF-I and mammographic density did not predict breast neoplastic events , nor did change in mammographic density . CONCLUSION Despite favorable effects on plasma IGF-I levels and mammographic density , the combination of low-dose tamoxifen plus fenretinide did not reduce breast neoplastic events compared to placebo , whereas both single agents , particularly fenretinide , showed numerical reduction in annual odds of breast neoplasms . Further follow-up is indicated |
1,389 | 23,922,186 | There was no consistent evidence to support a difference in AHFS patients receiving intravenous nitrate vasodilator therapy or alternative interventions with regard to the following secondary outcome measures : SBP change after 30 and 60 minutes , heart rate change after 90 minutes , and PAOP change after 90 minutes .
There appears to be no significant difference between nitrate vasodilator therapy and alternative interventions in the treatment of AHFS , with regard to symptom relief and haemodynamic variables .
Nitrates may be associated with a lower incidence of adverse effects after three hours compared with placebo . | BACKGROUND Current drug therapy for acute heart failure syndromes ( AHFS ) consists mainly of diuretics supplemented by vasodilators or inotropes .
Nitrates have been used as vasodilators in AHFS for many years and have been shown to improve some aspects of AHFS in some small studies .
The aim of this review was to determine the clinical efficacy and safety of nitrate vasodilators in AHFS .
OBJECTIVES To quantify the effect of different nitrate preparations ( isosorbide dinitrate and nitroglycerin ) and the effect of route of administration of nitrates on clinical outcome , and to evaluate the safety and tolerability of nitrates in the management of AHFS . | BACKGROUND The objective was to assess the safety and efficacy of L-NMMA in the treatment of cardiogenic shock . METHODS We enrolled 11 consecutive patients with cardiogenic shock that persisted after > 24 hours from admission , despite coronary catheterization and primary percutaneous transluminal coronary revascularization , when feasible , and treatment with mechanical ventilation , intraaortic balloon pump ( IABP ) , and high doses of catecholamines . L-NMMA was administered as an IV bolus of 1 mg/kg and continuous drip of 1 mg . kg(-1 ) . h(-1 ) for 5 hours . Treatment with catecholamines , mechanical ventilation , and IABP was kept constant throughout the study . RESULTS Within 10 minutes of L-NMMA administration , mean arterial blood pressure ( MAP ) increased from 76+/-9 to 109+/-22 mm Hg ( + 43 % ) . Urine output increased within 5 hours from 63+/-25 to 156+/-63 cc/h ( + 148 % ) . Cardiac index decreased during the steep increase in MAP from 2 . 0+/-0.5 to 1.7+/-0.4 L/(min . m(2 ) ) ( -15 % ) ; however , it gradually increased to 1.85+/-0.4 L/(min . m(2 ) ) after 5 hours . The heart rate and the wedge pressure remained stable . Twenty-four hours after L-NMMA discontinuation , MAP ( + 36 % ) and urine output ( + 189 % ) remained increased ; however , cardiac index returned to pretreatment level . No adverse events were detected . Ten out of eleven patients could be weaned off mechanical ventilation and IABP . Eight patients were discharged from the coronary intensive care unit , and seven ( 64 % ) were alive at 1-month follow-up . CONCLUSIONS L-NMMA administration in patients with cardiogenic shock is safe and has favorable clinical and hemodynamic effects Background —Few data are available on the impact of heart failure ( HF ) across all types of acute coronary syndromes ( ACS ) . Methods and Results —The Global Registry of Acute Coronary Events ( GRACE ) is a prospect i ve study of patients hospitalized with ACS . Data from 16 166 patients were analyzed : 13 707 patients without prior HF or cardiogenic shock at presentation were identified . Of these , 1778 ( 13 % ) had an admission diagnosis of HF ( Killip class II or III ) . HF on admission was associated with a marked increase in mortality rates during hospitalization ( 12.0 % versus 2.9 % [ with versus without HF ] , P < 0.0001 ) and at 6 months after discharge ( 8.5 % versus 2.8 % , P < 0.0001 ) . Of note , HF increased mortality rates in patients with unstable angina ( defined as ACS with normal biochemical markers of necrosis ; mortality rates : 6.7 % with versus 1.6 % without HF at admission , P < 0.0001 ) . By logistic regression analysis , admission HF was an independent predictor of hospital death ( odds ratio , 2.2 ; P < 0.0001 ) . Admission HF was associated with longer hospital stay and higher readmission rates . Patients with HF had lower rates of catheterization and percutaneous cardiac intervention , and fewer received & bgr;-blockers and statins . Hospital development of HF ( versus HF on presentation ) was associated with an even higher in-hospital mortality rate ( 17.8 % versus 12.0 % , P < 0.0001 ) . In patients with HF , in-hospital revascularization was associated with lower 6-month death rates ( 14.0 % versus 23.7 % , P < 0.0001 ; adjusted hazard ratio , 0.5 ; 95 % CI , 0.37 to 0.68 , P < 0.0001 ) . Conclusions —In this observational registry , heart failure was associated with reduced hospital and 6-month survival across all ACS subsets , including patients with normal markers of necrosis . More aggressive treatment of these patients may be warranted to improve prognosis BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences The results of this study showed an advantage of nesiritide compared with high-dose nitroglycerin in the treatment of patients with decompensated heart failure . Nesiritide result ed in an early decrease in pulmonary capillary wedge pressure ( < or = 15 minutes ) , which was sustained throughout the study period ( 24 hours ) without the need for up-titration . In contrast , the onset of the nitroglycerin-mediated hemodynamic effect was delayed , and despite aggressive up-titration , the decrease in pulmonary capillary wedge pressure was gradually attenuated because of the early development of tolerance BACKGROUND To compare the safety and efficacy of nesiritide versus intravenous nitroglycerin ( NTG ) in patients with acute coronary syndromes enrolled in the Vasodilation in the Management of Acute Congestive heart failure trial . Methods and results Retrospective review of Vasodilation in the Management of Acute Congestive heart failure trial data for heart failure associated with prospect ively diagnosed acute coronary syndromes . Sixty-one patients were included ; 34 received nesiritide and 27 received NTG . Pulmonary capillary wedge pressure was measured in right heart-catheterized patients ( 11 nesiritide , 9 NTG ) . Death at 6 months occurred in 2 nesiritide and 5 NTG patients ( P>.2 ) . Hypotension occurred in 4 nesiritide and 3 NTG patients ( P>.6 ) . At 24 hours , pulmonary capillary wedge pressure improvements persisted ( P=.001 ) in the nesiritide group , whereas the NTG group had returned to baseline ( P>.1 ) . In non-right heart-catheterized patients , 24-hour dyspnea scores were at least moderately improved in all nesiritide and 71 % of NTG ( P=.031 ) . At least minimal dyspnea improvement was seen in 100 % of nesiritide versus 71 % of NTG patients ( P>.3 ) , and 6-hour global clinical scores were at least moderately better in 75 % of nesiritide versus 32 % of NTG ( P=.031 ) . In non-right heart-catheterized patients , there were no 30-day readmissions with nesiritide versus 17 % with NTG ( P>.2 ) . CONCLUSIONS Nesiritide is as safe as NTG in heart failure patients with acute coronary syndromes BACKGROUND The leading cause of death in patients hospitalized for acute myocardial infa rct ion is cardiogenic shock . We conducted a r and omized trial to evaluate early revascularization in patients with cardiogenic shock . METHODS Patients with shock due to left ventricular failure complicating myocardial infa rct ion were r and omly assigned to emergency revascularization ( 152 patients ) or initial medical stabilization ( 150 patients ) . Revascularization was accomplished by either coronary-artery bypass grafting or angioplasty . Intraaortic balloon counterpulsation was performed in 86 percent of the patients in both groups . The primary end point was mortality from all causes at 30 days . Six-month survival was a secondary end point . RESULTS The mean age of the patients was 66+/-10 years , 32 percent were women and 55 percent were transferred from other hospitals . The median time to the onset of shock was 5.6 hours after infa rct ion , and most infa rcts were anterior in location . Ninety-seven percent of the patients assigned to revascularization underwent early coronary angiography , and 87 percent underwent revascularization ; only 2.7 percent of the patients assigned to medical therapy crossed over to early revascularization without clinical indication . Overall mortality at 30 days did not differ significantly between the revascularization and medical-therapy groups ( 46.7 percent and 56.0 percent , respectively ; difference , -9.3 percent ; 95 percent confidence interval for the difference , -20.5 to 1.9 percent ; P=0.11 ) . Six-month mortality was lower in the revascularization group than in the medical-therapy group ( 50.3 percent vs. 63.1 percent , P=0.027 ) . CONCLUSIONS In patients with cardiogenic shock , emergency revascularization did not significantly reduce overall mortality at 30 days . However , after six months there was a significant survival benefit . Early revascularization should be strongly considered for patients with acute myocardial infa rct ion complicated by cardiogenic shock OBJECTIVE To determine the feasibility , safety and efficacy of bilevel positive airway ventilation ( BiPAP ) in the treatment of severe pulmonary edema compared to high dose nitrate therapy . BACKGROUND Although noninvasive ventilation is increasingly used in the treatment of pulmonary edema , its efficacy has not been compared prospect ively with newer treatment modalities . METHODS We enrolled 40 consecutive patients with severe pulmonary edema ( oxygen saturation < 90 % on room air prior to treatment ) . All patients received oxygen at a rate of 10 liter/min , intravenous ( IV ) furosemide 80 mg and IV morphine 3 mg . Thereafter patients were r and omly allocated to receive 1 ) repeated boluses of IV isosorbide-dinitrate ( ISDN ) 4 mg every 4 min ( n = 20 ) , and 2 ) BiPAP ventilation and st and ard dose nitrate therapy ( n = 20 ) . Treatment was administered until oxygen saturation increased above 96 % or systolic blood pressure decreased to below 110 mm Hg or by more than 30 % . Patients whose conditions deteriorated despite therapy were intubated and mechanically ventilated . All treatment was delivered by mobile intensive care units prior to hospital arrival . RESULTS Patients treated by BiPAP had significantly more adverse events . Two BiPAP treated patients died versus zero in the high dose ISDN group . Sixteen BiPAP treated patients ( 80 % ) required intubation and mechanical ventilation compared to four ( 20 % ) in the high dose ISDN group ( p = 0.0004 ) . Myocardial infa rct ion ( MI ) occurred in 11 ( 55 % ) and 2 ( 10 % ) patients , respectively ( p = 0.006 ) . The combined primary end point ( death , mechanical ventilation or MI ) was observed in 17 ( 85 % ) versus 5 ( 25 % ) patients , respectively ( p = 0.0003 ) . After 1 h of treatment , oxygen saturation increased to 96 + /- 4 % in the high dose ISDN group as compared to 89 + /- 7 % in the BiPAP group ( p = 0.017 ) . Due to the significant deterioration observed in patients enrolled in the BiPAP arm , the study was prematurely terminated by the safety committee . CONCLUSIONS High dose ISDN is safer and better than BiPAP ventilation combined with conventional therapy in patients with severe pulmonary edema The immediate haemodynamic effects of intravenous frusemide ( 1 mg/kg ) and intravenous isosorbide dinitrate ( 50 - 200 micrograms/kg/h ) were compared in a prospect i ve , r and omised , between-group study in 28 men with radiographic and haemodynamic evidence of left ventricular failure following acute myocardial infa rct ion . The diuresis induced by frusemide reduced the left heart filling pressure and cardiac output and transiently raised systemic blood-pressure . In contrast , isosorbide dinitrate was accompanied by a reduction in systemic blood-pressure and peripheral resistance with the result that the cardiac output was not decreased despite a large fall in the pulmonary vascular and left heart filling pressures . These results indicate that reduction of excessive preload by venodilatation may be haemodynamically superior to that induced by diuresis in terms of both reducing myocardial oxygen consumption and maintaining peripheral perfusion . The influence of these contrasting treatments on the prognosis of these high-risk patients warrants further study A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis BACKGROUND Nitrates are superior to furosemide in the management of acute pulmonary edema associated with myocardial infa rct ion ; however , their role in the absence of infa rct ion is unclear . METHODS AND RESULTS A r and omized comparison was undertaken of the relative effectiveness of primary therapy with either intravenous morphine/furosemide ( men/women ; n = 32 ) or nitroglycerin/N-acetylcysteine ( NTG/NAC ; n = 37 ) in consecutive patients with acute pulmonary edema . The primary end point was change in PaO2/FIO2 over the first 60 minutes of therapy . Secondary end points were needed for mechanical respiratory assistance ( ie , continuous positive airway pressure via mask or intubation and ventilation ) and changes in other gas exchange parameters . Both treatment groups showed improvement in oxygenation after 60 minutes of therapy ; however , this reached statistical significance only with NTG/NAC therapy . There was no significant difference between groups in the assessed parameters ( 95 % CI for differences in Pao2/FIO2 : furosemide/morphine -12 to 23 and NTG/NAC 4 to 44 ) , a finding also confirmed in 32 patients presenting with respiratory failure . Only 11 % of the study group required mechanical ventilatory assistance ( continuous positive airway pressure in 4 patients and intubation and ventilation in 3 patients ) . CONCLUSIONS NTG/NAC therapy is as effective as furosemide/morphine in the initial management of acute pulmonary edema , regardless of the presence or absence of respiratory failure . The necessity for mechanical ventilatory assistance is infrequent in these patients , regardless of the initial medical treatment regimen OBJECTIVES The objective of this study was to evaluate the addition of intravenous ( IV ) tezosentan to st and ard therapy for patients with pulmonary edema . BACKGROUND Tezosentan is an IV nonselective endothelin (ET)-1 antagonist that yields favorable hemodynamic effects in patients with acute congestive heart failure ( CHF ) . METHODS Pulmonary edema was defined as acute CHF leading to respiratory failure , as evidence d by an oxygen saturation ( SO(2 ) ) < 90 % by pulse oxymeter despite oxygen treatment . All patients received oxygen 8 l/min through a face mask , 3 mg of IV morphine , 80 mg of furosemide , and 1 to 3 mg/h continuous drip isosorbide-dinitrate according to their blood pressure level and were r and omized to receive a placebo or tezosentan ( 50 or 100 mg/h ) for up to 24 h. RESULTS Eighty-four patients were r and omized . The primary end point , the change in SO(2 ) from baseline to 1 h , was 9.1 + /- 6.3 % in the placebo arm versus 7.6 + /- 10 % in the tezosentan group ( p = NS ) . The incidence of death , recurrent pulmonary edema , mechanical ventilation , and myocardial infa rct ion during the first 24 h of treatment was 19 % in both groups . Reduced baseline SO(2 ) , lower echocardiographic ejection fraction , high baseline mean arterial blood pressure ( MAP ) , and inappropriate vasodilation ( MAP reduction at 30 min of < 5 % or > 30 % ) correlated with worse outcomes . A post-hoc analysis revealed that the outcome of patients who received only 50 mg/h tezosentan was better than patients in the placebo group whereas patients receiving 100 mg/h had the worst outcomes . CONCLUSIONS In the present study , tezosentan ( an ET-1 antagonist ) did not affect the outcome of pulmonary edema , possibly because of the high dose used A prospect i ve r and omised trial compared the immediate haemodynamic effects of intravenous diuretic ( frusemide ) , venodilator ( isosorbide dinitrate ) . arteriolar dilator ( hydralazine ) , and positive inotropie stimulation ( prenalterol ) as first-line therapy for acute left ventricular ( LV ) failure following myocardial infa rct ion . Forty-eight patients with transmural myocardial infa rct ion and a pulmonary artery occluded pressure ( PAOP ) of > 20 mm Hg were studied within 18 h of admission to a coronary care unit . Both frusemide ( -4 mm Hg : p < 0.01 ) and isosorbide dinitrate ( -6 mm Hg : p < 0.01 ) reduced LV filling pressure without change in cardiac index and heart rate . Although both hydralazine and prenalterol increased cardiac index ( p < 0.01 ) , the reduction in LV filling pressure ( -2 mm Hg : p < 0.05 ) was less than with frusemide and isosorbide dinitrate . and was associated with an increased heart rate ( + 8 and + 13 beats min−1 : p < 0.01 ) . These data suggest that in acute heart failure following myocardial infa rct ion the four treatment modalities could be ranked in descending order of potential benefit as follows : ( a ) venodilatation ( isosorbide dinitrate ) — decrease of LV pressure/work : ( b ) diuretic therapy (frusemide)— decrease of LV pressure/work offset by a transient pressor effect : ( c ) arteriolar dilatation ( hydralazine ) —decrease of LV pressure/work and of PAOP . but offset by tachycardia : and ( d ) positive inotropic therapy ( β1-agonist prenalterol ) — tachycardia and augmented LV afterload . Combination of the former and latter agents , because of their differing modes of action , should offer haemodynamic advantages over monotherapy and deserves further evaluation BACKGROUND The purpose of this study was to determine which pressure-based hemodynamic factor was most closely associated with the transition from chronic compensated to acute decompensated heart failure . METHODS AND RESULTS Intracardiac pressures were retrospectively examined in 274 heart failure patients using an implantable hemodynamic monitor . The relationship between the development of a heart failure-related event ( HFRE ) and 3 pressure variables were analyzed : peak estimated pulmonary artery diastolic pressure ( ePAD ) at the time of an HFRE , change in ePAD from baseline to peak pressure , and the product of ePAD pressure and time ( P × T ) calculated as the area under the pressure-versus-time curve from baseline to peak pressure . Patients without an HFRE served as control subjects . Peak ePAD and change in ePAD were not closely associated with the development of an HFRE . In patients with an HFRE , P × T was 221 ± 130 mm Hg·days with only 4 % of the P × T values < 60 mm Hg·days . In contrast , in patients without an HFRE , the P × T was 5 ± 23 with only 4 % of the P × T values > 60 mm Hg·days . CONCLUSIONS The product of small increases in pressure that occur over an extended period of time ( P × T ) is the pressure-based hemodynamic factor most closely associated with the transition to acute decompensated heart failure BACKGROUND Nitrates and furosemide , commonly administered in the treatment of pulmonary oedema , have not been compared in a prospect i ve clinical trial . We compared the efficacy and safety of these drugs in a r and omised trial of patients with severe pulmonary oedema and oxygen saturation below 90 % . METHODS Patients presenting to mobile emergency units with signs of congestive heart failure were treated with oxygen 10 L/min , intravenous furosemide 40 mg , and morphine 3 mg bolus . 110 patients were r and omly assigned either to group A , who received isosorbide dinitrate ( 3 mg bolus administered intravenously every 5 min ; n=56 ) or to group B , who received furosemide ( 80 mg bolus administered intravenously every 15 min , as well as isosorbide dinitrate 1 mg/h , increased every 10 min by 1 mg/h ; n=54 ) . Six patients were withdrawn on the basis of chest radiography results . Treatment was continued until oxygen saturation was above 96 % or mean arterial blood pressure had decreased by 30 % or to below 90 mm Hg . The main endpoints were death , need for mechanical ventilation , and myocardial infa rct ion . The analyses were by intention to treat . FINDINGS Mechanical ventilation was required in seven ( 13 % ) of 52 group-A patients and 21 ( 40 % ) of 52 group-B patients ( p=0.0041 ) . Myocardial infa rct ion occurred in nine ( 17 % ) and 19 ( 37 % ) patients , respectively ( p=0.047 ) . One patient in group A and three in group B died ( p=0.61 ) . One or more of these endpoints occurred in 13 ( 25 % ) and 24 ( 46 % ) patients , respectively ( p=0.041 ) . INTERPRETATION High-dose isosorbide dinitrate , given as repeated intravenous boluses after low-dose intravenous furosemide , is safe and effective in controlling severe pulmonary oedema . This treatment regimen is more effective than high-dose furosemide with low-dose isosorbide nitrate in terms of need for mechanical ventilation and frequency of myocardial infa rct ion BACKGROUND Left ventricular dilatation and neuroendocrine activation are common after acute anterior myocardial infa rct ion . Long-term treatment with an angiotensin-converting-enzyme ( ACE ) inhibitor may improve outcome by attenuating these processes . We investigated whether the ACE inhibitor zofenopril , administered for six weeks after anterior myocardial infa rct ion , could improve both short-term and long-term outcome . METHODS A total of 1556 patients were enrolled within 24 hours after the onset of symptoms of acute anterior myocardial infa rct ion , and they were r and omly assigned in a double-blind fashion to receive either placebo ( 784 patients ) or zofenopril ( 772 patients ) for six weeks . At this time we assessed the incidence of death or severe congestive heart failure . The patients were reexamined after one year to assess survival . RESULTS The incidence of death or severe congestive heart failure at six weeks was significantly reduced in the zofenopril group ( 55 patients , 7.1 percent ) , as compared with the placebo group ( 83 patients , 10.6 percent ) ; the cumulative reduction in the risk of death or severe congestive heart failure was 34 percent ( 95 percent confidence interval , 8 to 54 percent ; P = 0.018 ) . The reduction in risk was 46 percent ( 95 percent confidence interval , 11 to 71 percent ; P = 0.018 ) for severe congestive heart failure and 25 percent ( 95 percent confidence interval , -11 to 60 percent ; P = 0.19 ) for death . After one year of observation , the mortality rate was significantly lower in the zofenopril group ( 10.0 percent ) than in the placebo group ( 14.1 percent ) ; the reduction in risk was 29 percent ( 95 percent confidence interval , 6 to 51 percent ; P = 0.011 ) . CONCLUSIONS Treatment with zofenopril significantly improved both short-term and long-term outcome when this drug was started within 24 hours after the onset of acute anterior myocardial infa rct ion and continued for six weeks BACKGROUND The purpose of this study was to develop an automated surveillance system , using pressure-based hemodynamic factors that would detect which patients were making the transition from compensated to decompensated heart failure before they developed worsening symptoms and required acute medical care . METHODS AND RESULTS Intracardiac pressures in 274 patients with heart failure were measured using an implantable hemodynamic monitor ( IHM ) and were analyzed in a retrospective manner . An automated pressure change detection ( PCD ) algorithm was developed using the cumulative sum method . The performance characteristics of the PCD algorithm were defined in all patients who developed a heart failure-related event ( HFRE ) ; patients without HFRE served as controls . Optimal PCD threshold values were chosen using a receiver operator curve analysis . Each of the pressures measured with the IHM were evaluated using the PCD analysis . All had sensitivities ≥80 % and false-positive rates < 4.7/patient-year ; however , estimated pulmonary artery diastolic pressure ( ePAD ) had the best performance . An ePAD based on the optimized PCD threshold of 6.0 yielded a sensitivity of 83 % and a false-positive rate of 4.1/patient-year for detecting patients making the transition from compensated to decompensated heart failure . These performance characteristics were not significantly different for patients with an ejection fraction > vs. < 50 % , estimated glomerular filtration rate > vs. < 60 mL/min/1.73 m(2 ) , or age > vs. < 60 years . CONCLUSIONS The automated PCD algorithm had high sensitivity and acceptable false-positive rates in detecting the development of decompensated heart failure before the patient developed worsening symptoms and required acute medical care . These data support the development of a prospect i ve study to examine the utility of adding an automated PCD algorithm to IHM-based management strategies to prevent decompensated heart failure |
1,390 | 28,616,656 | Conclusion The data suggest that NGAL levels can be an important biomarker for the early detection of AKI in children | Objective To estimate the accuracy of Neutrophil Gelatinase-Associated Lipocalin ( NGAL ) as a biomarker for acute kidney injury ( AKI ) in children . | BACKGROUND Acute renal failure ( ARF ) is associated with high mortality . Presently , no specific therapy for ARF exists . Therefore , early detection of ARF is critical to prevent its progression . However , serum creatinine , the st and ard marker to detect ARF , demonstrates major limitations . We prospect ively evaluated whether serum cystatin C detected ARF earlier than serum creatinine . METHODS In 85 patients at high risk to develop ARF , serum creatinine and cystatin C were determined daily . ARF was defined according to the Risk of renal dysfunction , Injury to the kidney , Failure of kidney function , Loss of kidney function , and ESRD ( RIFLE ) classification when creatinine increased by > /=50 % ( R- criteria ) , by > /=100 % ( I- criteria ) , or by > /=200 % ( F- criteria ) . In analogy , ARF was detected when cystatin C increased by > /=50 % , by > /=100 % , or by > /=200 % . RESULTS Forty-four patients developed ARF and 41 served as controls . In ARF by R- , I- , and F- criteria , the increase of cystatin C significantly preceded that of creatinine . Specifically , serum cystatin C increased already by > /=50 % 1.5 + /- 0.6 days earlier compared to creatinine . Serum cystatin C demonstrated a high diagnostic value to detect ARF as indicated by area under the curve of the ROC analysis of 0.82 and 0.97 on the two days before the R- criteria was fulfilled by creatinine . Cystatin C detected ARF according to the R- criteria with a sensitivity of 55 % and 82 % on these days , respectively . Cystatin C also performed excellently , detecting ARF defined by the I- and F- criteria two days prior to creatinine , and moderately well predicting renal replacement therapy in the further course of ARF . Additionally , low T(3)- or T(3)/T(4 ) syndrome , glucocorticoid deficiency and excess did not affect cystatin C levels , adding to its usefulness in critically ill patients with ARF . CONCLUSION Serum cystatin C is a useful detection marker of ARF , and may detect ARF one to two days earlier than creatinine We hypothesized that neutrophil gelatinase-associated lipocalin ( NGAL ) is an early predictive biomarker of contrast-induced nephropathy ( CIN ) . We prospect ively enrolled 91 children ( age 0–18 years ) with congenital heart disease undergoing elective cardiac catheterization and angiography with contrast administration ( CC ; Ioversol ) . Serial urine and plasma sample s were analyzed in a double-blind fashion by NGAL enzyme-linked immunosorbent assay ( ELISA ) . CIN , defined as a 50 % increase in serum creatinine from baseline , was found in 11 subjects ( 12 % ) , but detection using increase in serum creatinine was only possible 6–24 h after CC . In contrast , significant elevation of NGAL concentrations in urine ( 135 ± 32 vs. 11.6 ± 2 ng/ml without CIN , p < 0.001 ) and plasma ( 151 ± 34 vs. 36 ± 4 without CIN , p < 0.001 ) were noted within 2 h after CC in those subjects . Using a cutoff value of 100 ng/ml , sensitivity , specificity , and area under the receiver-operating characteristic ( ROC ) curve for prediction of CIN were excellent for the 2-h urine NGAL ( 73 % , 100 % , and 0.92 , respectively ) and 2-h plasma NGAL ( 73 % , 100 % , and 0.91 , respectively ) . By multivariate analysis , the 2-h NGAL concentrations in the urine ( R2 = 0.52 , p < 0.0001 ) and plasma ( R2 = 0.72 , p < 0.0001 ) were found to be powerful independent predictors of CIN . Patient demographics and contrast volume were not predictive of CIN Introduction Serum creatinine is a late marker of acute kidney injury ( AKI ) . Urine neutrophil gelatinase-associated lipocalin ( uNGAL ) is an early marker of AKI , where the timing of kidney injury is known . It is unknown whether uNGAL predicts AKI in the general critical care setting . We assessed the ability of uNGAL to predict AKI development and severity in critically ill children . Methods This was a prospect i ve cohort study of critically ill children . Children aged between 1 month and 21 years who were mechanically ventilated and had a bladder catheter inserted were eligible . Patients with end-stage renal disease or who had just undergone kidney transplantation were excluded . Patients were enrolled within 24 to 48 hours of initiation of mechanical ventilation . Clinical data and serum creatinine were collected daily for up to 14 days from enrollment , and urine was collected once daily for up to 4 days for uNGAL measurement . AKI was grade d using pRIFLE ( pediatric modified Risk , Injury , Failure , Loss , End Stage Kidney Disease ) criteria . Day 0 was defined as the day on which the AKI initially occurred , and pRIFLEmax was defined as the worst pRIFLE AKI grade recorded during the study period . The χ2 test was used to compare associations between categorical variables . Mann-Whitney and Kruskal-Wallis tests were used to compare continuous variables between groups . Diagnostic characteristics were evaluated by calculating sensitivity and specificity , and constructing receiver operating characteristic curves . Results A total of 140 patients ( 54 % boys , mean ± st and ard deviation Pediatric Risk of Mortality II score 15.0 ± 8.0 , 23 % sepsis ) were included . Mean and peak uNGAL concentrations increased with worsening pRIFLEmax status ( P < 0.05 ) . uNGAL concentrations rose ( at least sixfold higher than in controls ) in AKI , 2 days before and after a 50 % or greater rise in serum creatinine , without change in control uNGAL . The parameter uNGAL was a good diagnostic marker for AKI development ( area under the receiver operating characteristic curve [ AUC ] 0.78 , 95 % confidence interval [ CI ] 0.62 to 0.95 ) and persistent AKI for 48 hours or longer ( AUC 0.79 , 95 % CI 0.61 to 0.98 ) , but not for AKI severity , when it was recorded after a rise in serum creatinine had occurred ( AUC 0.63 , 95 % CI 0.44 to 0.82 ) . Conclusion We found uNGAL to be a useful early AKI marker that predicted development of severe AKI in a heterogeneous group of patients with unknown timing of kidney injury Introduction Acute kidney injury ( AKI ) is a frequent complication of cardiopulmonary bypass ( CPB ) . The lack of early biomarkers has impaired our ability to intervene in a timely manner . We previously showed in a small cohort of patients that plasma neutrophil gelatinase-associated lipocalin ( NGAL ) , measured using a research enzyme-linked immunosorbent assay , is an early predictive biomarker of AKI after CPB . In this study we tested whether a point-of-care NGAL device can predict AKI after CPB in a larger cohort . Methods First , in a cross-sectional pilot study including 40 plasma sample s ( NGAL range 60 to 730 ng/ml ) and 12 calibration st and ards ( NGAL range 0 to 1,925 ng/ml ) , NGAL measurements by enzyme-linked immunosorbent assay and by Triage ® NGAL Device ( Biosite Inc. , San Diego , CA , USA ) were highly correlated ( r = 0.94 ) . Second , in a subsequent prospect i ve uncontrolled cohort study , 120 children undergoing CPB were enrolled . Plasma was collected at baseline and at frequent intervals for 24 hours after CPB , and analyzed for NGAL using the Triage ® NGAL device . The primary outcome was AKI , which was defined as a 50 % or greater increase in serum creatinine . Results AKI developed in 45 patients ( 37 % ) , but the diagnosis using serum creatinine was delayed by 2 to 3 days after CPB . In contrast , mean plasma NGAL levels increased threefold within 2 hours of CPB and remained significantly elevated for the duration of the study . By multivariate analysis , plasma NGAL at 2 hours after CPB was the most powerful independent predictor of AKI ( β = 0.004 , P < 0.0001 ) . For the 2-hour plasma NGAL measurement , the area under the curve was 0.96 , sensitivity was 0.84 , and specificity was 0.94 for prediction of AKI using a cut-off value of 150 ng/ml . The 2 hour postoperative plasma NGAL levels strongly correlated with change in creatinine ( r = 0.46 , P < 0.001 ) , duration of AKI ( r = 0.57 , P < 0.001 ) , and length of hospital stay ( r = 0.44 , P < 0.001 ) . The 12-hour plasma NGAL strongly correlated with mortality ( r = 0.48 , P = 0.004 ) and all measures of morbidity mentioned above . Conclusion Accurate measurements of plasma NGAL are obtained using the point-of-care Triage ® NGAL device . Plasma NGAL is an early predictive biomarker of AKI , morbidity , and mortality after pediatric CPB BACKGROUND The epidemiologic characteristics of children and young adults with acute kidney injury have been described in single‐center and retrospective studies . We conducted a multinational , prospect i ve study involving patients admitted to pediatric intensive care units to define the incremental risk of death and complications associated with severe acute kidney injury . METHODS We used the Kidney Disease : Improving Global Outcomes criteria to define acute kidney injury . Severe acute kidney injury was defined as stage 2 or 3 acute kidney injury ( plasma creatinine level ≥2 times the baseline level or urine output < 0.5 ml per kilogram of body weight per hour for ≥12 hours ) and was assessed for the first 7 days of intensive care . All patients 3 months to 25 years of age who were admitted to 1 of 32 participating units were screened during 3 consecutive months . The primary outcome was 28‐day mortality . RESULTS A total of 4683 patients were evaluated ; acute kidney injury developed in 1261 patients ( 26.9 % ; 95 % confidence interval [ CI ] , 25.6 to 28.2 ) , and severe acute kidney injury developed in 543 patients ( 11.6 % ; 95 % CI , 10.7 to 12.5 ) . Severe acute kidney injury conferred an increased risk of death by day 28 after adjustment for 16 covariates ( adjusted odds ratio , 1.77 ; 95 % CI , 1.17 to 2.68 ) ; death occurred in 60 of the 543 patients ( 11.0 % ) with severe acute kidney injury versus 105 of the 4140 patients ( 2.5 % ) without severe acute kidney injury ( P<0.001 ) . Severe acute kidney injury was associated with increased use of mechanical ventilation and renal‐replacement therapy . A stepwise increase in 28‐day mortality was associated with worsening severity of acute kidney injury ( P<0.001 by log‐rank test ) . Assessment of acute kidney injury according to the plasma creatinine level alone failed to identify acute kidney injury in 67.2 % of the patients with low urine output . CONCLUSIONS Acute kidney injury is common and is associated with poor outcomes , including increased mortality , among critically ill children and young adults . ( Funded by the Pediatric Nephrology Center of Excellence at Cincinnati Children 's Hospital Medical Center and others ; AWARE Clinical Trials.gov number , NCT01987921 . Acute kidney injury ( AKI ) causes increased morbidity in critically ill children and damage to the kidney , a central mediator of homeostasis in the body , affects survival . The incidence of AKI in pediatrics is significant and despite alarming data , therapeutic interventions have failed to effect a meaningful difference in outcomes . In this review , we will discuss the epidemiology of AKI in pediatrics , treatment strategies attempted to date , experimental therapies targeting molecular patterns associated with AKI , and highlight the needed direction of AKI research and management . Prospect i ve trials in pediatrics are needed to test the validity of diagnostic tools , to identify the point of most efficacious intervention , and to underscore the therapies that can be effective in the different downstream effects of AKI Acute kidney injury ( AKI ) occurs commonly after pediatric cardiac surgery and associates with poor outcomes . Biomarkers may help the prediction or early identification of AKI , potentially increasing opportunities for therapeutic interventions . Here , we conducted a prospect i ve , multicenter cohort study involving 311 children undergoing surgery for congenital cardiac lesions to evaluate whether early postoperative measures of urine IL-18 , urine neutrophil gelatinase-associated lipocalin ( NGAL ) , or plasma NGAL could identify which patients would develop AKI and other adverse outcomes . Urine IL-18 and urine and plasma NGAL levels peaked within 6 hours after surgery . Severe AKI , defined by dialysis or doubling in serum creatinine during hospital stay , occurred in 53 participants at a median of 2 days after surgery . The first postoperative urine IL-18 and urine NGAL levels strongly associated with severe AKI . After multivariable adjustment , the highest quintiles of urine IL-18 and urine NGAL associated with 6.9- and 4.1-fold higher odds of AKI , respectively , compared with the lowest quintiles . Elevated urine IL-18 and urine NGAL levels associated with longer hospital stay , longer intensive care unit stay , and duration of mechanical ventilation . The accuracy of urine IL-18 and urine NGAL for diagnosis of severe AKI was moderate , with areas under the curve of 0.72 and 0.71 , respectively . The addition of these urine biomarkers improved risk prediction over clinical models alone as measured by net reclassification improvement and integrated discrimination improvement . In conclusion , urine IL-18 and urine NGAL , but not plasma NGAL , associate with subsequent AKI and poor outcomes among children undergoing cardiac surgery Background : Diarrhea-associated hemolytic uremic syndrome ( D+HUS ) causes acute renal failure . Neutrophil gelatinase-associated lipocalcin ( NGAL ) is an early indicator of kidney injury . Objective : To determine if urinary NGAL excretion is a biomarker of severe renal injury and predicts the need for dialysis in D+HUS . Methods : Patients were r and omly selected from among participants in the SYNSORB Pk trial . Urine sample s were collected daily if available during the first week of hospitalization . NGAL levels were determined by ELISA . Results : 34 children , age 5.9±3.9 yr , were studied ; ten ( 29 % ) required dialysis . Patients were categorized based on urinary NGAL concentration within five days of hospitalization - < 200 ng/ml and ≥200 ng/ml . Twenty patients ( 58 % ) had increased urinary NGAL excretion . The severity of D+HUS at enrollment was similar in the two groups . However , children with increased urinary NGAL levels had higher peak BUN and creatinine concentrations ( P<0.01 ) and required dialysis more often , 9/20 versus 1/14 ( P=0.024 ) compared to children with normal excretion . Conclusion : The majority of patients with D+HUS have renal tubular epithelial injury , as evidence d by elevated urinary NGAL excretion . Urinary NGAL levels below 200 ng/ml within five days of hospitalization may be an adjunctive marker that defines less severe renal involvement Acute kidney injury ( AKI ) is a potential complication for children with congenital heart disease ( CHD ) after cardiopulmonary bypass ( CPB ) surgery . This study was design ed to investigate and compare the predictive values of urinary biomarkers for AKI after CPB surgery in infants and young children and to determine the optimal timing of testing and the cutoff value for each biomarker . The study prospect ively enrolled 58 CHD children 3 years of age or younger who were undergoing CPB surgery . Urinary neutrophil gelatinase-associated lipocalin ( NGAL ) , interleukin-18 ( IL-18 ) , microalbumin ( MA ) , N-acetyl-ß-D-glucosaminidase ( NAG ) , α1-microglobulin ( α1-MG ) , and creatinine ( UCr ) were measured at baseline and at various time points after surgery . Children who experienced AKI had more complex cardiac surgical procedures as evaluated by Risk Adjustment for Congenital Heart Surgery 1 ( RACHS-1 ) , longer CPB and aortic clamping times , and worse clinical outcomes than those who did not . In the AKI group , all five urinary biomarkers increased substantially and peaked at 4 h after surgery . In contrast , in the non-AKI group , they increased slightly or had no significant changes during the first 24 h. All the biomarkers had the best predictive performances at 4 h after surgery . At this time point , NAG had the minimum area under the curve ( AUC ) ( 0.747 ) , which was significantly lower than that of the others ( AUC , 0.82–0.85 ; P < 0.05 ) . The optimal cutoff value of each biomarker was 290 ng/mg UCr for NAGL , 1,477 pg/mg UCr for IL-18 , 400 mg/g UCr for MA , 225 U/g UCr for NAG , and 290 mg/g UCr for α1-MG . In conclusion , urinary NGAL , IL-18 , MA , and α1-MG had similar predictive performances for the early detection of AKI after CPB surgery in infants and young children Background . About 30–50 % patients develop acute kidney injury ( AKI ) after cardiac surgery , which is still diagnosed by serum creatinine on clinic . However , the increase of serum creatinine is insensitive and delayed . The aim of this study is to test the hypothesis that neutrophil gelatinase-associated lipocalin ( NGAL ) and interleukin-18 ( IL-18 ) are early biomarkers for AKI in patients after cardiac surgery . Methods . Thirty-three cases undergoing cardiac surgery were classified into an AKI group and non-AKI group , according to the AKI definition ( > 26.5 μmol/L increase of serum creatinine , more than or equal to 50 % increase of serum creatinine within 48 h , or a reduction in urine output < 0.5 mL/Kg per hour for more than six hours ) . The concentrations of serum NGAL , urine NGAL , and urine IL-18 at different time-points were measured . Results . Nine cases ( 27.27 % ) developed postoperative AKI , but diagnosis with serum creatinine was 12–48 h postoperation . The concentrations of serum NGAL were not significantly increased postoperation . The concentrations of urine NGAL and IL-18 were significantly increased in the AKI group , which reached the peak at 2–4 h postoperation , and a more significant difference could be seen after correction for urine creatinine . The concentrations of urine NGAL and IL-18 2 h postoperation , either corrected for urine creatinine or not , showed good sensitivity and specificity . Increased levels of urine NGAL and IL-18 2 h postoperation were significantly correlated with increased level of serum creatinine 12 h postoperation . Logistic regression analysis showed that urine NGAL corrected for urine creatinine 2 h postoperation and urine IL-18 2 h postoperation emerged as powerful independent predictors of AKI after cardiac surgery . Conclusions . The concentrations of urine NGAL and IL-18 could be useful biomarkers for AKI in patients after cardiac surgery , especially after correction for urine creatinine |
1,391 | 26,346,232 | Safety analysis found that the overall risks for all-cause mortality and adverse events were similar in both the TDC and medical therapy groups .
The combined data from recent RCTs have shown no statistically significant differences between TDC and medical therapy in the prevention of recurrent ischemic stroke .
TDC closure was associated with an increased risk of atrial fibrillation but not with serious adverse events | BACKGROUND The optimal therapy for preventing recurrent stroke in people with cryptogenic stroke and patent foramen ovale ( PFO ) has not been defined .
The choice between medical therapy ( antithrombotic treatment with antiplatelet agents or anticoagulants ) and transcatheter device closure has been the subject of intense debate over the past several years .
Despite the lack of scientific evidence , a substantial number of people undergo transcatheter device closure ( TDC ) for secondary stroke prevention .
OBJECTIVES To : 1 ) compare the safety and efficacy of TDC with best medical therapy alone for preventing recurrent stroke ( fatal or non-fatal ) or transient ischemic attacks ( TIAs ) in people with PFO and a history of cryptogenic stroke or TIA ; 2 ) identify specific subgroups of people most likely to benefit from closure for secondary prevention ; and 3 ) assess the cost-effectiveness of this strategy , if possible . | Since initial reports of its association with ischemic stroke appeared in 1988 , there has been continued controversy regarding the existence and strength of the association between patent foramen ovale ( PFO ) and ischemic stroke . Many case-control studies have reported an association between incident cryptogenic ischemic stroke and PFO , yet population -based studies have failed to confirm this association . Studies of the risk of recurrent stroke in patients with cryptogenic stroke with or without PFO have not shown an increased risk of recurrent stroke in patients with PFO . Meanwhile , use of devices to close PFOs and atrial septal defects percutaneously has increased dramatically since their introduction . Completion of the r and omized clinical trials of PFO closure currently in progress is vital to determine if the benefits of PFO closure in cryptogenic stroke outweigh its risks BACKGROUND Whether closure of a patent foramen ovale is effective in the prevention of recurrent ischemic stroke in patients who have had a cryptogenic stroke is unknown . We conducted a trial to evaluate whether closure is superior to medical therapy alone in preventing recurrent ischemic stroke or early death in patients 18 to 60 years of age . METHODS In this prospect i ve , multicenter , r and omized , event-driven trial , we r and omly assigned patients , in a 1:1 ratio , to medical therapy alone or closure of the patent foramen ovale . The primary results of the trial were analyzed when the target of 25 primary end-point events had been observed and adjudicated . RESULTS We enrolled 980 patients ( mean age , 45.9 years ) at 69 sites . The medical-therapy group received one or more antiplatelet medications ( 74.8 % ) or warfarin ( 25.2 % ) . Treatment exposure between the two groups was unequal ( 1375 patient-years in the closure group vs. 1184 patient-years in the medical-therapy group , P=0.009 ) owing to a higher dropout rate in the medical-therapy group . In the intention-to-treat cohort , 9 patients in the closure group and 16 in the medical-therapy group had a recurrence of stroke ( hazard ratio with closure , 0.49 ; 95 % confidence interval [ CI ] , 0.22 to 1.11 ; P=0.08 ) . The between-group difference in the rate of recurrent stroke was significant in the prespecified per- protocol cohort ( 6 events in the closure group vs. 14 events in the medical-therapy group ; hazard ratio , 0.37 ; 95 % CI , 0.14 to 0.96 ; P=0.03 ) and in the as-treated cohort ( 5 events vs. 16 events ; hazard ratio , 0.27 ; 95 % CI , 0.10 to 0.75 ; P=0.007 ) . Serious adverse events occurred in 23.0 % of the patients in the closure group and in 21.6 % in the medical-therapy group ( P=0.65 ) . Procedure-related or device-related serious adverse events occurred in 21 of 499 patients in the closure group ( 4.2 % ) , but the rate of atrial fibrillation or device thrombus was not increased . CONCLUSIONS In the primary intention-to-treat analysis , there was no significant benefit associated with closure of a patent foramen ovale in adults who had had a cryptogenic ischemic stroke . However , closure was superior to medical therapy alone in the prespecified per- protocol and as-treated analyses , with a low rate of associated risks . ( Funded by St. Jude Medical ; RESPECT Clinical Trials.gov number , NCT00465270 . ) Background and Purpose The etiology of ischemic stroke affects prognosis , outcome , and management . Trials of therapies for patients with acute stroke should include measurements of responses as influenced by subtype of ischemic stroke . A system for categorization of subtypes of ischemic stroke mainly based on etiology has been developed for the Trial of Org 10172 in Acute Stroke Treatment ( TOAST ) . Methods A classification of subtypes was prepared using clinical features and the results of ancillary diagnostic studies . “ Possible ” and “ probable ” diagnoses can be made based on the physician 's certainty of diagnosis . The usefulness and interrater agreement of the classification were tested by two neurologists who had not participated in the writing of the criteria . The neurologists independently used the TOAST classification system in their bedside evaluation of 20 patients , first based only on clinical features and then after review ing the results of diagnostic tests . Results The TOAST classification denotes five subtypes of ischemic stroke : 1 ) large-artery atherosclerosis , 2 ) cardioembolism , 3 ) small-vessel occlusion , 4 ) stroke of other determined etiology , and 5 ) stroke of undetermined etiology . Using this rating system , interphysician agreement was very high . The two physicians disagreed in only one patient . They were both able to reach a specific etiologic diagnosis in 11 patients , whereas the cause of stroke was not determined in nine . Conclusions The TOAST stroke subtype classification system is easy to use and has good interobserver agreement . This system should allow investigators to report responses to treatment among important subgroups of patients with ischemic stroke . Clinical trials testing treatments for acute ischemic stroke should include similar methods to diagnose subtypes of stroke In a prospect i ve study of 1,805 hospitalized patients in the Stroke Data Bank of the National Institute of Neurological and Communicative Disorders and Stroke , the 1,273 with infa rct ion were classified into diagnostic subtypes . Diagnosis was based on the clinical history , examination , and laboratory tests including computed tomography , noninvasive vascular imaging , and where safe and relevant , angiography . Five hundred and eight cases ( fully 40 % ) were labeled as infa rcts of undetermined cause ( IUC ) , of which 138 ( 27 % ) were evaluated with both computed tomography and angiography . The clinical syndrome and computed tomographic and angiographic findings in 91 ( 65.9 % ) of these 138 IUC cases were clearly not attributable to large‐artery thrombosis and could permit reclassification of the infa rct as due to some form of embolism . Failure to define a source of embolus kept them in the category of IUC . Thirty‐one cases ( 22.5 % ) could be reclassified as due to stenosis or thrombosis of a large artery , and 16 ( 11.6 % ) as lacunar infa rct ion . To determine if those selected for angiography among the IUC patients differed from those with other final diagnoses , a stepwise multiple logistic model was used . The most important characteristics were young age , presence of a superficial infa rct , prior transient ischemic attack , low weakness score , and presentation with a nonlacunar syndrome . The results of the model suggest that angiography use was determined by clinical characteristics uniformly across centers and not by final diagnosis . Continued use of the category IUC may help clarify risk factors and stroke subtypes , allow new mechanisms of ischemic stroke to be uncovered , and prevent classification categories of stroke used in clinical trials from becoming too broad Patients with patent foramen ovale ( PFO ) and paradoxical embolism are at increased risk for recurrent events . Percutaneous PFO closure is a new treatment modality aim ed at secondary prevention . We report the multicenter experience of interventional closure of PFO using two different devices in 272 patients . The mean age was 51 ± 14.2 years and 52.9 % were males . The implantation procedure result ed in an initial complete shunt closure rate of 74.3 % with a periprocedural complication rate of 6.6 % . There were no deaths or pericardial tamponade . The mean procedure time was less than 44 min under either conscious sedation , local or general anesthesia . This is the largest report to date demonstrating the procedural safety , reliability , and feasibility of the transcatheter PFO closure technique with the STARFlex and CardioSEAL septal implants . R and omized clinical trials are currently in progress to identify patients most likely to benefit from this intervention . Catheter Cardiovasc Interv 2004;62:512–516 . © 2004 Wiley‐Liss , OBJECTIVES We sought to assess the risk of ischemic stroke from a patent foramen ovale ( PFO ) in the multiethnic prospect i ve cohort of northern Manhattan . BACKGROUND Patent foramen ovale has been associated with increased risk of ischemic stroke , mainly in case-control studies . The actual PFO-related stroke risk in the general population is unclear . METHODS The presence of PFO was assessed at baseline by using transthoracic 2-dimensional echocardiography with contrast injection in 1,100 stroke-free subjects older than 39 years of age ( mean age 68.7 + /- 10.0 years ) from the Northern Manhattan Study ( NOMAS ) . The presence of atrial septal aneurysm ( ASA ) also was recorded . Subjects were followed annually for outcomes . We assessed PFO/ASA-related stroke risk after adjusting for established stroke risk factors . RESULTS We detected PFO in 164 subjects ( 14.9 % ) ; ASA was present in 27 subjects ( 2.5 % ) and associated with PFO in 19 subjects . During a mean follow-up of 79.7 + /- 28.0 months , an ischemic stroke occurred in 68 subjects ( 6.2 % ) . After adjustment for demographics and risk factors , PFO was not found to be significantly associated with stroke ( hazard ratio 1.64 , 95 % confidence interval [ CI ] 0.87 to 3.09 ) . The same trend was observed in all age , gender , and race-ethnic subgroups . The coexistence of PFO and ASA did not increase the stroke risk ( adjusted hazard ratio 1.25 , 95 % CI 0.17 to 9.24 ) . Isolated ASA was associated with elevated stroke incidence ( 2 of 8 , or 25 % ; adjusted hazard ratio 3.66 , 95 % CI 0.88 to 15.30 ) . CONCLUSIONS Patent foramen ovale , alone or together with ASA , was not associated with an increased stroke risk in this multiethnic cohort . The independent role of ASA needs further assessment in appositely design ed and powered studies BACKGROUND The options for secondary prevention of cryptogenic embolism in patients with patent foramen ovale are administration of antithrombotic medications or percutaneous closure of the patent foramen ovale . We investigated whether closure is superior to medical therapy . METHODS We performed a multicenter , superiority trial in 29 centers in Europe , Canada , Brazil , and Australia in which the assessors of end points were unaware of the study -group assignments . Patients with a patent foramen ovale and ischemic stroke , transient ischemic attack ( TIA ) , or a peripheral thromboembolic event were r and omly assigned to undergo closure of the patent foramen ovale with the Amplatzer PFO Occluder or to receive medical therapy . The primary end point was a composite of death , nonfatal stroke , TIA , or peripheral embolism . Analysis was performed on data for the intention-to-treat population . RESULTS The mean duration of follow-up was 4.1 years in the closure group and 4.0 years in the medical-therapy group . The primary end point occurred in 7 of the 204 patients ( 3.4 % ) in the closure group and in 11 of the 210 patients ( 5.2 % ) in the medical-therapy group ( hazard ratio for closure vs. medical therapy , 0.63 ; 95 % confidence interval [ CI ] , 0.24 to 1.62 ; P=0.34 ) . Nonfatal stroke occurred in 1 patient ( 0.5 % ) in the closure group and 5 patients ( 2.4 % ) in the medical-therapy group ( hazard ratio , 0.20 ; 95 % CI , 0.02 to 1.72 ; P=0.14 ) , and TIA occurred in 5 patients ( 2.5 % ) and 7 patients ( 3.3 % ) , respectively ( hazard ratio , 0.71 ; 95 % CI , 0.23 to 2.24 ; P=0.56 ) . CONCLUSIONS Closure of a patent foramen ovale for secondary prevention of cryptogenic embolism did not result in a significant reduction in the risk of recurrent embolic events or death as compared with medical therapy . ( Funded by St. Jude Medical ; Clinical Trials.gov number , NCT00166257 . ) Background : The optimal management of patients with cryptogenic ischemic stroke found to have a patent foramen ovale ( PFO ) at diagnostic workup remains unclear . The aims of this observational multicenter study were to evaluate : ( 1 ) the risk of recurrent cerebrovascular events in patients with cryptogenic minor ischemic stroke or transient ischemic attack ( TIA ) and PFO who either underwent percutaneous PFO closure or received only medical treatment , and ( 2 ) the risk factors associated with recurrent events . Methods : Consecutive patients ( aged 55 years or less ) with first-ever cryptogenic minor ischemic stroke or TIA and PFO were recruited in 13 Italian hospitals between January 2006 and September 2007 and followed up for 2 years . Results : 238 patients were included in the study ( mean age 42.2 ± 10.0 years ; 118 males ) ; 117 patients ( 49.2 % ) received only antithrombotic therapy while 121 patients underwent percutaneous PFO closure ( 50.8 % ) . Stroke as the qualifying event was more common in the medical treatment group ( p = 0.01 ) . The presence of atrial septal aneurysm and evidence of 20 bubbles or more on transcranial Doppler were more common in the PFO closure group ( p = 0.002 and 0.02 ) . Eight patients ( 6.6 % ) experienced a nonfatal complication during PFO closure . At the 2-year follow-up , 17 recurrent events ( TIA or stroke ; 3.6 % per year ) were observed ; 7 of these events ( 2.9 % per year ) occurred in the percutaneous PFO closure group and 10 events ( 4.2 % per year ) in the medical treatment group . The rate of recurrent stroke was 0.4 % per year in patients who underwent percutaneous closure ( 1 event ) and 3.4 % per year in patients who received medical treatment ( 8 events ) . On multivariate analysis , percutaneous closure was not protective in preventing recurrent TIA or stroke ( OR = 0.1 , 95 % CI = 0.02–1.5 , p = 0.1 ) , while it was barely protective in preventing recurrent stroke ( OR = 0.1 , 95 % CI = 0.0–1.0 , p = 0.053 ) . Conclusions : The results of this observational , nonr and omized study suggest that PFO closure might be superior to medical therapy for the prevention of recurrent stroke . Periprocedural complications were the trade-off for this clinical benefit . Controlled r and omized clinical trials comparing percutaneous closure with medical management are required Closure of patent foramen ovale ( PFO ) has been proposed as an alternative to anticoagulation in patients with presumed paradoxical emboli . We report the immediate and mid‐term results of the phase 1 U.S. Multicenter Clinical Trial of patients who underwent transcatheter PFO closure for paradoxical embolism using the new Amplatzer PFO device . Fifty patients ( 28 male/22 female ) underwent catheter closure of their PFOs at a mean age of 41 ± 11 years . Thirty‐six patients had ischemic stroke , 10 had transient ischemic attack , and 4 had peripheral embolism . Seventeen patients had atrial septal aneurysm . The implantation procedure was successful in 49/49 patients ; one patient did not have a PFO . Complete closure was seen immediately after the procedure in 26/49 patients ; 17 had minimal residual shunt , 4 had moderate and 2 had large residual shunts . The median fluoroscopy time was 10.5 min ( 2.8–43 min ) . There were no complications related to the device . One patient developed an arteriovenous fistula at the catheter site requiring surgical repair . At a mean follow‐up interval of 16.5 ± 7.2 months , there were no deaths or recurrent neurological or peripheral embolic events . Eight patients reported an episode of dizziness or palpitations ( four of them within 18 days of the procedure ) . No episodes of atrial dysrhythmias were noted . Contrast bubble study at last follow‐up documented complete closure in 45/48 patients ; one patient had minimal , one had moderate residual shunt , and one had a large shunt . One patient was lost to follow‐up . We conclude that catheter closure of PFO associated with stroke/transient ischemic attack or peripheral embolism using the new Amplatzer PFO device is a safe and effective method in preventing recurrence of such episodes . R and omized clinical trials comparing device closure versus continued medical therapy are underway . Catheter Cardiovasc Interv 2003;60:524–528 . © 2003 Wiley‐Liss , Objectives : In Korea , stroke ranks as one of the leading causes of death along with cancer and ischemic heart disease . The purpose of this study was to better underst and clinical characteristics , risk factors and subtypes of acute stroke among Korean people . Method : 1,654 acute stroke patients within 7 days of onset were consecutively enrolled in the Hallym Stroke Registry ( HSR ) . The study was a prospect i ve hospital-based registry aided with a web-based , computerized data bank system . The project began in January 1996 and the data obtained until September 2002 were analyzed . The analysis was basically carried out regarding demographic features , risk factors , time elapsed before coming to the hospitals after the symptom onset , duration of hospitalization , and 30-day mortality rate . Results : 1,567 patients had ischemic stroke and 87 patients had hemorrhagic stroke . The mean age of the patients was 63.6 ± 11.8 years , and 815 patients ( 56.8 % ) were men . The estimated time interval between stroke onset and hospital visit was 1.3 days on average and the mean duration of hospital stay was 12.1 days . Only a small fraction ( 12 % ) of patients reached the hospital within 3 h after the symptom onset . As for the risk factors , hypertension topped for both ischemic and hemorrhagic strokes followed by smoking and prior history of stroke , diabetes , hyperlipidemia and cardioembolism . With respect to subtype classification of ischemic stroke , large-artery atherosclerosis was most frequent ( 42.0 % ) , followed by small-vessel occlusion ( 31.0 % ) , cardioembolism ( 8.7 % ) , other determined etiology ( 1.9 % ) , and undetermined etiology ( 16.4 % ) . The 30-day mortality rate was 7.2 % . Conclusion : In the HSR , demographic features were essentially comparable with other major registries . However , the data analysis varies from registry to registry . This may in part be due to a different study design , racial-ethnic differences and patient selection methods This r and omized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale ( PFO ) closure devices ( Amplatzer , Helex , and CardioSEAL-STARflex ) . It examined 660 patients ( 361 men , 299 women , mean age 49.3+/-1.9 years ) , with 220 patients per group . All patients had a history of paradoxical embolism . All PFO closures were successful technically . Exchange of devices for others was most frequently required for the Helex occluder ( 7 of 220 ) and 2 of 220 in either of the other groups . Three device embolizations in the Helex group were retrieved and replaced successfully . One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment . A hemopericardium in that group was punctured without affecting the device . One tamponade in the Amplatzer group required surgical device explantation . In 8 of 660 patients in the CardioSEAL-STARflex group , thrombi resolved after anticoagulation . Sixteen patients ( 11 in the CardioSEAL-STARflex group , 3 in the Amplatzer group , and 2 in the Helex group ) had episodes of atrial fibrillation . PFOs were closed completely in 143 of 220 patients ( 65 % ) in the Amplatzer group , 116 of 220 patients ( 52.7 % ) in the Helex group , and 137 of 220 patients ( 62.3 % ) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders ( p=0.0005 ) and the Helex and CardioSEAL-STARflex occluders ( p=0.0003 ) . PFO closure can be performed safely with each device . In conclusion , the Helex occluder embolized more frequently . Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder AIMS Percutaneous patent foramen ovale ( PFO ) closure for secondary stroke prevention is discussed controversially . Long-term data comparing different closure devices are limited . The objective is the prospect i ve comparison of procedural complications and long-term results after PFO closure in patients with cryptogenic stroke r and omized to three different closure devices . METHODS AND RESULTS Between January 2001 and December 2004 , 660 patients with cryptogenic stroke were r and omized to three different closure devices ( Amplatzer , CardioSEAL-STARflex , and Helex occluder , 220 patients per group ) . The primary endpoint was defined as recurrent cerebral ischaemia [ stroke , transient ischaemic attacks ( TIA ) , or Amaurosis fugax ] , death from neurological cause , or any other paradoxical embolism within 5 years after the index procedure . Device implantation was technically successful in all interventions ( n = 660 ; 100 % ) . The procedure was complicated by pericardial tamponade requiring surgery in one patient ( Amplatzer group ) and device embolization in three patients ( all Helex group ) . Thrombus formation on the device was detected in 12 cases ( 11 CardioSEALSTARflex , 1 Helex , 0 Amplatzer ; P < 0.0001 ) , of which 2 required surgery . Complete closure after single device implantation was more common with the Amplatzer and with the CardioSEAL-STARflex than with the Helex occluder : Amplatzer vs. Helex vs. CardioSEAL-STARflex : n = 217 ( 98.6 % ) vs. n = 202 ( 91.8 % ) vs. n = 213 ( 96.8 % ; P = 0.0012 ) . Within 5 years of follow-up , the primary endpoint occurred in 25 patients ( 3.8 % ; 10 TIAs , 12 strokes and 3 cases of cerebral death ) . Compared with the CardioSEAL-STARflex ( 6 % ; 6 TIAs , 6 strokes , 1 cerebral death ) and Helex groups ( 4 % ; 4 TIAs , 4 stroke , 1 cerebral death ) , significantly fewer events ( P = 0.04 ) occurred in the Amplatzer group ( 1.4 % ; 2 strokes , 1 cerebral death ) . CONCLUSION Although procedural complications and long-term neurological event rates are low regardless of the device used , the recurrent neurological event rate was significantly lower after Amplatzer than after CardioSEAL-STARflex or Helex implantation . This has important implication s regarding the interpretation of trials comparing PFO closure with medical management BACKGROUND The prevalence of patent foramen ovale among patients with cryptogenic stroke is higher than that in the general population . Closure with a percutaneous device is often recommended in such patients , but it is not known whether this intervention reduces the risk of recurrent stroke . METHODS We conducted a multicenter , r and omized , open-label trial of closure with a percutaneous device , as compared with medical therapy alone , in patients between 18 and 60 years of age who presented with a cryptogenic stroke or transient ischemic attack ( TIA ) and had a patent foramen ovale . The primary end point was a composite of stroke or transient ischemic attack during 2 years of follow-up , death from any cause during the first 30 days , or death from neurologic causes between 31 days and 2 years . RESULTS A total of 909 patients were enrolled in the trial . The cumulative incidence ( Kaplan-Meier estimate ) of the primary end point was 5.5 % in the closure group ( 447 patients ) as compared with 6.8 % in the medical-therapy group ( 462 patients ) ( adjusted hazard ratio , 0.78 ; 95 % confidence interval , 0.45 to 1.35 ; P=0.37 ) . The respective rates were 2.9 % and 3.1 % for stroke ( P=0.79 ) and 3.1 % and 4.1 % for TIA ( P=0.44 ) . No deaths occurred by 30 days in either group , and there were no deaths from neurologic causes during the 2-year follow-up period . A cause other than paradoxical embolism was usually apparent in patients with recurrent neurologic events . CONCLUSIONS In patients with cryptogenic stroke or TIA who had a patent foramen ovale , closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA . ( Funded by NMT Medical ; Clinical Trials.gov number , NCT00201461 . ) OBJECTIVES We sought to determine the association between patent foramen ovale ( PFO ) , atrial septal aneurysm ( ASA ) , and stroke prospect ively in a unselected population sample . BACKGROUND The disputed relationship between PFO and stroke reflects method ologic weaknesses in studies using invalid controls , unblinded transesophageal echocardiography examinations , and data that are unadjusted for age or comorbidity . METHODS The use of transesophageal echocardiography to identify PFO was performed by a single echocardiographer using st and ardized definitions in 585 r and omly sample d , Olmsted County ( Minnesota ) subjects age 45 years or older participating in the Stroke Prevention : Assessment of Risk in a Community ( SPARC ) study . RESULTS A PFO was identified in 140 ( 24.3 % ) subjects and ASA in 11 ( 1.9 % ) subjects . Of the 140 subjects with PFO , 6 ( 4.3 % ) had an ASA ; of the 437 subjects without PFO , 5 had an ASA ( 1.1 % , two-sided Fisher exact test , p = 0.028 ) . During a median follow-up of 5.1 years , cerebrovascular events ( cerebrovascular disease-related death , ischemic stroke , transient ischemic attack ) occurred in 41 subjects . After adjustment for age and comorbidity , PFO was not a significant independent predictor of stroke ( hazard ratio 1.46 , 95 % confidence interval 0.74 to 2.88 , p = 0.28 ) . The risk of a cerebrovascular event among subjects with ASA was nearly four times higher than that in those without ASA ( hazard ratio 3.72 , 95 % confidence interval 0.88 to 15.71 , p = 0.074 ) . CONCLUSIONS These prospect i ve population -based data suggest that , after correction for age and comorbidity , PFO is not an independent risk factor for future cerebrovascular events in the general population . A larger study is required to test the putative stroke risk associated with ASA |
1,392 | 24,026,850 | Exercise is moderately more effective than a control intervention for reducing symptoms of depression , but analysis of method ologically robust trials only shows a smaller effect in favour of exercise .
When compared to psychological or pharmacological therapies , exercise appears to be no more effective , though this conclusion is based on a few small trials | BACKGROUND Depression is a common and important cause of morbidity and mortality worldwide .
Depression is commonly treated with antidepressants and /or psychological therapy , but some people may prefer alternative approaches such as exercise .
There are a number of theoretical reasons why exercise may improve depression .
This is an up date of an earlier review first published in 2009 .
OBJECTIVES To determine the effectiveness of exercise in the treatment of depression in adults compared with no treatment or a comparator intervention . | Aims : The aim of this study was to evaluate the effect of combined resistance and home-based walking exercise on glycemic and metabolic control , depression and quality of life in type-2 diabetes patients . Methods : This prospect i ve study was conducted at a private hospital in Turkey . Thirty-six type-2 diabetic patients participated in the study . Subjects were r and omly distributed in one 8 week exercise intervention or in one control group . Exercise program consisted of resistance training and home-based walking . Before and after the training program , muscular strength , fasting blood glucose , hemoglobin A1C , ( HbA1C ) and plasma lipid values , quality of life and symptoms of depression of the patients were assessed . Results : Exercise group 's baseline HbA1C was significantly higher than the control groups ( p < 0.05 ) ; other blood parameters were similar between the two groups ( p>0.05 ) . At the baseline no significant differences were observed in the depression and four subscales ( physical function , physical role , bodily pain , and general health perceptions ) of the SF-36 between the exercise and control groups ( p>0.05 ) . The exercise group had higher scores of emotional role , vitality and mental health subscales than the control groups after the training programs ( p<0.05 ) . Conclusion : Exercise training which included resistance training and home- based walking could be safe , effective and beneficial in diabetic patients BACKGROUND Regular physical exercise may improve a variety of physiological and psychological factors in depressive persons . However , there is little experimental evidence to support this assumption for adolescent population s. We conducted a r and omized controlled trial to investigate the effect of physical exercise on depressive state , the excretions of stress hormones and physiological fitness variables in adolescent females with depressive symptoms . METHODS Forty-nine female volunteers ( aged 18 - 20 years ; mean 18.8 + /- 0.7 years ) with mild-to-moderate depressive symptoms , as measured by the Centre for Epidemiologic Studies Depression ( CES-D ) scale , were r and omly assigned to either an exercise regimen or usual daily activities for 8 weeks . The subjects were then crossed over to the alternate regimen for an additional 8-week period . The exercise program consisted of five 50-min sessions per week of a group jogging training at a mild intensity . The variables measured were CES-D rating scale , urinary cortisol and epinephrine levels , and cardiorespiratory factors at rest and during exercise endurance test . RESULTS After the sessions of exercise the CES-D total depressive score showed a significant decrease , whereas no effect was observed after the period of usual daily activities ( ANOVA ) . Twenty-four hour excretions of cortisol and epinephrine in urine were reduced due to the exercise regimen . The training group had a significantly reduced resting heart rate and increased peak oxygen uptake and lung capacity . CONCLUSIONS The findings of this study suggest that a group jogging exercise may be effective in improving depressive state , hormonal response to stress and physiological fitness of adolescent females with depressive symptoms Background Depression is a disabling , prevalent condition . Physical activity programs may assist depression management in older people , ameliorate co-morbid conditions and reduce the need for antidepressants . The UPLIFT pilot study assessed the feasibility of older depressed people attending a community-based progressive resistance training ( PRT ) program . The study also aim ed to determine whether PRT improves depressive status in older depressed patients . Methods A r and omised controlled trial was conducted . People aged ≥ 65 years with depressive symptoms were recruited via general practice s. Following baseline assessment , subjects were r and omly allocated to attend a local PRT program three times per week for 10 weeks or a brief advice control group . Follow-up assessment of depressive status , physical and psychological health , functional and quality of life status occurred post intervention and at six months . Results Three hundred and forty six people responded to the study invitation , of whom 22 % had depressive symptoms ( Geriatric Depression Scale , GDS-30 score ≥ 11 ) . Thirty two people entered the trial . There were no significant group differences on the GDS at follow-up . At six months there was a trend for the PRT intervention group to have lower GDS scores than the comparison group , but this finding did not reach significance ( p = 0.08 ) . More of the PRT group ( 57 % ) had a reduction in depressive symptoms post program , compared to 44 % of the control group . It was not possible to discern which specific components of the program influenced its impact , but in post hoc analyses , improvement in depressive status appeared to be associated with the number of exercise sessions completed ( r = -0.8 , p < 0.01 ) . Conclusion The UPLIFT pilot study confirmed that older people with depression can be successfully recruited to a community based PRT program . The program can be offered by existing community-based facilities , enabling its ongoing implementation for the potential benefit of other older people BACKGROUND Although exercise has been shown to relieve depression , little is known about its mechanism or dose-response characteristics . We hypothesized that high intensity progressive resistance training ( PRT ) would be more effective than either low intensity PRT or st and ard care by a general practitioner ( GP ) in depressed elderly persons , and that high intensity PRT would provide superior benefits in quality of life , sleep quality , and self-efficacy . METHODS Sixty community-dwelling adults > 60 years with major or minor depression were r and omized to supervised high intensity PRT ( 80 % maximum load ) or low intensity PRT ( 20 % maximum load ) 3 days per week for 8 weeks , or GP care . RESULTS A 50 % reduction in the Hamilton Rating Scale of Depression score was achieved in 61 % of the high intensity , 29 % of the low intensity , and 21 % of the GP care group ( p = .03 ) . Strength gain was directly associated with reduction in depressive symptoms ( r = 0.40 , p = .004 ) , as was baseline social support network type ( F = 3.52 , p = .015 ) , whereas personality type , self-efficacy , and locus of control were unrelated to the antidepressant effect . Vitality quality -of-life scale improved more in the high intensity group than in the others ( p = .04 ) . Sleep quality improved significantly in all participants ( p < .0001 ) , with the greatest relative change in high intensity PRT ( p = .05 ) . CONCLUSIONS High intensity PRT is more effective than is low intensity PRT or GP care for the treatment of older depressed patients Dance and movement therapy are consisted of music , easy exercises and sensorial stimulus and provide drugless treatment for the depression on low rates . In this study , it has been aim ed to examine the effect of dance over the depression . A total of 120 healthy male and female conservatory students ranged from 20 and 24 ages volunteered to participate in this study . They were divided r and omly into 1 of 2 groups : dance training group ( DTG ; N = 60 ) and control group ( CG ; N = 60 ) . A dance training program was applied to the subjects three days a week ( Tuesday , Thursday , and Saturday ) during 12 weeks . The subjects in the control group did not participate in the training and participated only in the pre and post test measurements . Beck Depression Scale was used for the pre and post test measurements of subjects . 12 weeks of dance training has been found to be effective on the depression levels of the subjects participating in the research as the training group ( p < 0.05 ) . The depression level of males and females before training has meaningfully decreased after 12 weeks of dance training ( p < 0.05 ) . When the depression levels of the subjects participated in research as the control group were separately evaluated for males and females , no meaningful change has been found in the depression levels during 12 weeks ( p > 0.05 ) . In conclusion , it has been seen that dance affects the depression levels of university students positively and decreases their depression levels CONTEXT Many observational studies have shown that physical activity reduces the risk of cognitive decline ; however , evidence from r and omized trials is lacking . OBJECTIVE To determine whether physical activity reduces the rate of cognitive decline among older adults at risk . DESIGN AND SETTING R and omized controlled trial of a 24-week physical activity intervention conducted between 2004 and 2007 in metropolitan Perth , Western Australia . Assessors of cognitive function were blinded to group membership . PARTICIPANTS We recruited volunteers who reported memory problems but did not meet criteria for dementia . Three hundred eleven individuals aged 50 years or older were screened for eligibility , 89 were not eligible , and 52 refused to participate . A total of 170 participants were r and omized and 138 participants completed the 18-month assessment . INTERVENTION Participants were r and omly allocated to an education and usual care group or to a 24-week home-based program of physical activity . MAIN OUTCOME MEASURE Change in Alzheimer Disease Assessment Scale-Cognitive Subscale ( ADAS-Cog ) scores ( possible range , 0 - 70 ) over 18 months . RESULTS In an intent-to-treat analysis , participants in the intervention group improved 0.26 points ( 95 % confidence interval , -0.89 to 0.54 ) and those in the usual care group deteriorated 1.04 points ( 95 % confidence interval , 0.32 to 1.82 ) on the ADAS-Cog at the end of the intervention . The absolute difference of the outcome measure between the intervention and control groups was -1.3 points ( 95 % confidence interval,-2.38 to -0.22 ) at the end of the intervention . At 18 months , participants in the intervention group improved 0.73 points ( 95 % confidence interval , -1.27 to 0.03 ) on the ADAS-Cog , and those in the usual care group improved 0.04 points ( 95 % confidence interval , -0.46 to 0.88 ) . Word list delayed recall and Clinical Dementia Rating sum of boxes improved modestly as well , whereas word list total immediate recall , digit symbol coding , verbal fluency , Beck depression score , and Medical Outcomes 36-Item Short-Form physical and mental component summaries did not change significantly . CONCLUSIONS In this study of adults with subjective memory impairment , a 6-month program of physical activity provided a modest improvement in cognition over an 18-month follow-up period . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12605000136606 The present study evaluated the effectiveness of a short-term mind-body intervention program on improving the depressive mood of an adult community sample . Forty adult volunteers with various degrees of depressive mood were r and omly assigned to the experimental group ( Dejian Mind-Body Intervention , DMBI ) and control group ( Cognitive-Behavioral Therapy , CBT ) . For each group , a total of four 90-min weekly sessions were conducted . Treatment-related changes were measured using the Beck Depression Inventory ( BDI-II ) , an electroencephalographic indicator of positive affect ( i.e. , prefrontal activation asymmetry ) , and self-report ratings on physical health . Results indicated that both the DMBI and the CBT group demonstrated significant reduction in depressive mood . However , among individuals with moderate to severe depressive mood at baseline , only those in the DMBI but not the CBT group showed significant reduction in depressive mood . Besides , only the DMBI group demonstrated a significant increase in prefrontal activation asymmetry , suggesting increase in positive affect . While most psychological therapies for depressive mood normally take several months to show treatment effect , the present findings provided initial data suggesting that the DMBI was effective in improving depressive mood of community adults after 1 month of training OBJECTIVES Based on the model by Tsang et al. ( 2002 ) which summarized the etiological factors and consequences of depression in elderly with chronic physical illnesses , a r and omized clinical trial of a special form of Qigong ( The Eight Section Brocades ) was conducted to assess if it improved the biopsychosocial health of participants . DESIGN 50 geriatric patients in sub-acute stage of chronic physical illnesses were recruited and r and omly assigned into the intervention and control group . The intervention group was given a 12-week period of Qigong practice while the control group was given traditional remedial rehabilitation activities . RESULTS The intervention group participants expressed improvement in physical health , ADL , psychological health , social relationship , and health in general as reflected by scores of the Perceived Benefit Question naire and informal feedback . CONCLUSION Although results are not significant in the generalization measures , it may be due to small effect size , small sample size , and short intervention period . Although not all of the hypotheses are supported , this report shows that Qigong ( the Eight Section Brocades ) is promising as an alternative intervention for elderly with chronic physical illness to improve their biopsychosocial health . More systematic evaluation with larger sample size and longer period of intervention is now underway in Hong Kong . Results will be reported once available We examined the effects of two physical activity modes on depressive symptoms over a 5-year period among older adults and change in physical self-esteem as a mediator of changes in depressive symptoms . Formerly sedentary , older adults ( N = 174 ) were r and omly assigned into 6-month conditions of either walking or low-intensity resistance/flexibility training . Depressive symptoms and physical self-esteem were measured before and after the 6-month intervention , and 12 and 60 months after intervention initiation . Depressive symptoms scores were decreased immediately after the intervention , followed by a sustained reduction for 12 and 60 months after intervention initiation ; there was no differential pattern of change between the physical activity modes . Change in physical self-esteem predicted change in depressive symptoms . This study supports the effectiveness of an exercise intervention for the sustained reduction of depressive symptoms among sedentary older adults and physical self-esteem as a potential mediator of this effect BACKGROUND Previous observational and interventional studies have suggested that regular physical exercise may be associated with reduced symptoms of depression . However , the extent to which exercise training may reduce depressive symptoms in older patients with major depressive disorder ( MDD ) has not been systematic ally evaluated . OBJECTIVE To assess the effectiveness of an aerobic exercise program compared with st and ard medication ( ie , antidepressants ) for treatment of MDD in older patients , we conducted a 16-week r and omized controlled trial . METHODS One hundred fifty-six men and women with MDD ( age , > or = 50 years ) were assigned r and omly to a program of aerobic exercise , antidepressants ( sertraline hydrochloride ) , or combined exercise and medication . Subjects underwent comprehensive evaluations of depression , including the presence and severity of MDD using Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and Hamilton Rating Scale for Depression ( HAM-D ) and Beck Depression Inventory ( BDI ) scores before and after treatment . Secondary outcome measures included aerobic capacity , life satisfaction , self-esteem , anxiety , and dysfunctional cognitions . RESULTS After 16 weeks of treatment , the groups did not differ statistically on HAM-D or BDI scores ( P = .67 ) ; adjustment for baseline levels of depression yielded an essentially identical result . Growth curve models revealed that all groups exhibited statistically and clinical ly significant reductions on HAM-D and BDI scores . However , patients receiving medication alone exhibited the fastest initial response ; among patients receiving combination therapy , those with less severe depressive symptoms initially showed a more rapid response than those with initially more severe depressive symptoms . CONCLUSIONS An exercise training program may be considered an alternative to antidepressants for treatment of depression in older persons . Although antidepressants may facilitate a more rapid initial therapeutic response than exercise , after 16 weeks of treatment exercise was equally effective in reducing depression among patients with MDD OBJECTIVES The aim of this study was to assess the efficacy of exercise and antidepressant medication in reducing depressive symptoms and improving cardiovascular biomarkers in depressed patients with coronary heart disease . BACKGROUND Although there is good evidence that clinical depression is associated with poor prognosis , optimal therapeutic strategies are currently not well defined . METHODS One hundred one out patients with coronary heart disease and elevated depressive symptoms underwent assessment of depression , including a psychiatric interview and the Hamilton Rating Scale for Depression . Participants were r and omized to 4 months of aerobic exercise ( 3 times/week ) , sertraline ( 50 - 200 mg/day ) , or placebo . Additional assessment s of cardiovascular biomarkers included measures of heart rate variability , endothelial function , baroreflex sensitivity , inflammation , and platelet function . RESULTS After 16 weeks , all groups showed improvement on Hamilton Rating Scale for Depression scores . Participants in both the aerobic exercise ( mean -7.5 ; 95 % confidence interval : -9.8 to -5.0 ) and sertraline ( mean -6.1 ; 95 % confidence interval : -8.4 to -3.9 ) groups achieved larger reductions in depressive symptoms compared with those receiving placebo ( mean -4.5 ; 95 % confidence interval : -7.6 to -1.5 ; p = 0.034 ) ; exercise and sertraline were equally effective at reducing depressive symptoms ( p = 0.607 ) . Exercise and medication tended to result in greater improvements in heart rate variability compared with placebo ( p = 0.052 ) ; exercise tended to result in greater improvements in heart rate variability compared with sertraline ( p = 0.093 ) . CONCLUSIONS Both exercise and sertraline result ed in greater reductions in depressive symptoms compared to placebo in patients with coronary heart disease . Evidence that active treatments may also improve cardiovascular biomarkers suggests that they may have a beneficial effect on clinical outcomes as well as on quality of life . ( Exercise to Treat Depression in Individuals With Coronary Heart Disease ; NCT00302068 ) Objectives : In a trial completed in 2010 , US patients with diabetes and depression were r and omized to usual care or telephone cognitive behavioural therapy that emphasized physical activity . Twelve-month intervention effects were observed for blood pressure , depression , and pedometer-measured step-counts . This study examined variation in intervention effects across patient subgroups defined by a measure of clinical complexity . Methods : Three groups of patients were identified at baseline using the Vector Model of Complexity that recognizes socioeconomic , biological , behavioural , and other determinants of treatment response . Complexity-by-intervention interactions were examined using regression models . Results : Intervention effects for blood pressure , depression , and step-counts differed across complexity levels ( each p < 0.01 ) . Effects on Beck Depression Inventory scores were greater in the low-complexity group ( −8.8 ) than in the medium- ( −3.2 ) or high-complexity groups ( −2.7 ) . Physical activity effects also were greatest in the low-complexity group ( increase of 1498 steps per day ) . In contrast , systolic blood pressure effects were greater among intervention patients with high complexity ( −8.5 mmHg ) . Conclusions : This intervention had varying impacts on physical and mental health depending on patients ' clinical complexity . Physical activity and depressive symptom gains may be more likely among less complex patients , although more complex patients may achieve cardiovascular benefits through decreased blood pressures OBJECTIVE Our objective was to study the effects of physical training combined with dietary measures in obese adults . In a second step , we sought to compare two training protocol s and establish the additional contribution of strength training . METHODS We performed a r and omized , prospect i ve survey from July 2004 to November 2007 . Included patients were r and omized into three groups : a control group ( G1 ) , a group ( G2 ) performing dietary measures and a programme of treadmill training at 60 % of each individual 's maximum heart rate ( HRmax ) and a group ( G3 ) who followed the G2 programme supplemented with strength training . All patients underwent an initial and final assessment of anthropometric & cardiovascular parameters , muscle strength , dyspnoea during activities of daily living , metabolic disorders , psychological status and quality of life . RESULTS The greatest weight loss ( 7.24 % ) was observed in G3 . Reduction in waistline measurement ( WL ) of 4.3 % and 10.26 % were noted in G2 and G3 , respectively ( p < 0.001 ) . The percentage fat body mass fell by 10.4 % in G3 ( p < 0.001 ) and 8.6 % in G2 ( p = 0.03).We particularly noted an improvement in physical condition in groups 2 and 3 , with lower HR and blood pressure values at rest and at maximum effort . The overall improvement in both arm and leg muscle strength was greater for G3 than for G2 . Likewise , we noted an improvement in the metabolic parameters and depression & anxiety scores for the trained groups ( G2 , G3 ) , relative to the control group ( G1 ) . We also noted improvements in the total impact of weight on quality of life ( IWQOL ) lite score of 15.2 % in G2 and 18 % in G3 . CONCLUSION Our survey demonstrated the beneficial effect of combining dietary measures and physical training in obese patients . In addition to weight loss , the programme enabled a reduction in the patients ' body fat mass and abdominal obesity , a correction of metabolic disorders and an improvement in aerobic capacity . The improvement in all these parameters also enhanced the patients ' psychological status and quality of life . The addition of strength training produced notable improvements in weight loss , arm muscle strength and abdominal obesity CONTEXT Research both in the United States and abroad suggests that significant numbers of people are involved with various forms of alternative medicine . However , the reasons for such use are , at present , poorly understood . OBJECTIVE To investigate possible predictors of alternative health care use . METHODS Three primary hypotheses were tested . People seek out these alternatives because ( 1 ) they are dissatisfied in some way with conventional treatment ; ( 2 ) they see alternative treatments as offering more personal autonomy and control over health care decisions ; and ( 3 ) the alternatives are seen as more compatible with the patients ' values , worldview , or beliefs regarding the nature and meaning of health and illness . Additional predictor variables explored included demographics and health status . DESIGN A written survey examining use of alternative health care , health status , values , and attitudes toward conventional medicine . Multiple logistic regression analyses were used in an effort to identify predictors of alternative health care use . SETTING AND PARTICIPANTS A total of 1035 individuals r and omly selected from a panel who had agreed to participate in mail surveys and who live throughout the United States . MAIN OUTCOME MEASURE Use of alternative medicine within the previous year . RESULTS The response rate was 69 % . The following variables emerged as predictors of alternative health care use : more education ( odds ratio [ OR ] , 1.2 ; 95 % confidence interval [ CI ] , 1.1 - 1.3 ) ; poorer health status ( OR , 1.3 ; 95 % CI , 1.1 - 1.5 ) ; a holistic orientation to health ( OR , 1.4 ; 95 % CI , 1.1 - 1.9 ) ; having had a transformational experience that changed the person 's worldview ( OR , 1 .8 ; 95 % CI , 1 .3 - 2.5 ) ; any of the following health problems : anxiety ( OR , 3.1 ; 95 % CI , 1.6 - 6.0 ) ; back problems ( OR , 2.3 ; 95 % CI , 1 .7 - 3.2 ) ; chronic pain ( OR , 2.0 ; 95 % CI , 1.1 -3.5 ) ; urinarytract problems ( OR , 2.2 ; 95 % CI , 1.3 - 3.5 ) ; and classification in a cultural group identifiable by their commitment to environmentalism , commitment to feminism , and interest in spirituality and personal growth psychology ( OR , 2.0 ; 95 % CI , 1.4 - 2.7 ) . Dissatisfaction with conventional medicine did not predict use of alternative medicine . Only 4.4 % of those surveyed reported relying primarily on alternative therapies . CONCLUSION Along with being more educated and reporting poorer health status , the majority of alternative medicine users appear to be doing so not so much as a result of being dissatisfied with conventional medicine but largely because they find these health care alternatives to be more congruent with their own values , beliefs , and philosophical orientations toward health and life BACKGROUND Nearly two-thirds of elderly patients treated for depression fail to achieve symptomatic remission and functional recovery with first-line pharmacotherapy . In this study , we ask whether a mind-body exercise , Tai Chi Chih ( TCC ) , added to escitalopram will augment the treatment of geriatric depression design ed to achieve symptomatic remission and improvements in health functioning and cognitive performance . METHODS : One hundred twelve older adults with major depression age 60 years and older were recruited and treated with escitalopram for approximately 4 weeks . Seventy-three partial responders to escitalopram continued to receive escitalopram daily and were r and omly assigned to 10 weeks of adjunct use of either 1 ) TCC for 2 hours per week or 2 ) health education ( HE ) for 2 hours per week . All participants underwent evaluations of depression , anxiety , resilience , health-related quality of life , cognition , and inflammation at baseline and during 14-week follow-up . RESULTS Subjects in the escitalopram and TCC condition were more likely to show greater reduction of depressive symptoms and to achieve a depression remission as compared with those receiving escitalopram and HE . Subjects in the escitalopram and TCC condition also showed significantly greater improvements in 36-Item Short Form Health Survey physical functioning and cognitive tests and a decline in the inflammatory marker , C-reactive protein , compared with the control group . CONCLUSION : Complementary use of a mind-body exercise , such as TCC , may provide additional improvements of clinical outcomes in the pharmacologic treatment of geriatric depression Background : Interrelations of exercise , mood , and weight reduction are unclear in the behavioral treatment of obesity . Methods : Obese women volunteers with high tension ( anxiety ) ( T ) , depression ( D ) , or total mood disturbance ( TMD ) scores , who were previously r and omized into conditions of ( 1 ) exercise supported by The Coach Approach : a protocol based on social cognitive and self-efficacy theory ( CA ; n = 53 , 66 , and 60 , respectively ) , ( 2 ) personal demonstration and follow up of exercise methods ( EX ; n = 27 , 27 , and 21 , respectively ) , and ( 3 ) exercise suggested through written information only ( INFO ; n = 24 , 28 , and 20 , respectively ) , were subjects . Identical nutrition information was provided to all subjects in a small group format . Results : Minutes of exercise over the 6-month study were greatest in the CA condition , with minutes in the EX condition greater than the INFO condition . T , D , and TMD scores were reduced to normal levels mostly in the CA condition , with the EX condition having significantly more normalized D scores than the INFO . Across conditions , normalized mood scores generally predicted a greater reduction in waist circumference , with CA associated with additional benefits when D scores were considered . Conclusion : Properly accounting for exercise-induced mood change may be important in the behavioral treatment of obesity The prevalence of mental health disorders among college students is rising and the increasing rates of anxiety and depression have important societal implication s. Physical activity has been proposed as an adjuvant to traditional treatment approaches ( i.e. psychotherapy or pharmacotherapy ) , and the internet is a potentially useful means of delivering physical activity information to the college-aged population . This r and omized pilot trial examined the effects of an internet-based physical activity intervention on physical activity , self-efficacy , depression , and anxiety in college students ( n = 47 ) receiving mental health counseling . Physical activity , depression , anxiety , exercise self-efficacy , and barriers self-efficacy were assessed at baseline and post-intervention . There was a significant time effect for physical activity , with both groups increasing their physical activity levels across the 10-week intervention but with a larger increase in the intervention condition ( d = 0.68 ) than the control condition ( d = 0.05 ) . Exercise and barriers self-efficacy declined across the intervention , but more so in the control than intervention condition . Effects on depression and anxiety were nonsignificant . Finally , correlation analyses showed increases in physical activity were associated with increases in exercise self-efficacy ( r = 0.62 ) and barriers self-efficacy ( r = 0.63 ) and decreases in depression ( r = −0.44 ) in the intervention condition , but not in the control condition . These results suggest that an internet-delivered physical activity intervention may be a promising approach to promoting physical activity among college students undergoing mental health counseling Objective : To assess whether patients receiving aerobic exercise training performed either at home or in a supervised group setting achieve reductions in depression comparable to st and ard antidepressant medication ( sertraline ) and greater reductions in depression compared to placebo controls . Methods : Between October 2000 and November 2005 , we performed a prospect i ve , r and omized controlled trial ( SMILE study ) with allocation concealment and blinded outcome assessment in a tertiary care teaching hospital . A total of 202 adults ( 153 women ; 49 men ) diagnosed with major depression were assigned r and omly to one of four conditions : supervised exercise in a group setting ; home-based exercise ; antidepressant medication ( sertraline , 50–200 mg daily ) ; or placebo pill for 16 weeks . Patients underwent the structured clinical interview for depression and completed the Hamilton Depression Rating Scale ( HAM-D ) . Results : After 4 months of treatment , 41 % of the participants achieved remission , defined as no longer meeting the criteria for major depressive disorder ( MDD ) and a HAM-D score of < 8 . Patients receiving active treatments tended to have higher remission rates than the placebo controls : supervised exercise = 45 % ; home-based exercise = 40 % ; medication = 47 % ; placebo = 31 % ( p = .057 ) . All treatment groups had lower HAM-D scores after treatment ; scores for the active treatment groups were not significantly different from the placebo group ( p = .23 ) . Conclusions : The efficacy of exercise in patients seems generally comparable with patients receiving antidepressant medication and both tend to be better than the placebo in patients with MDD . Placebo response rates were high , suggesting that a considerable portion of the therapeutic response is determined by patient expectations , ongoing symptom monitoring , attention , and other nonspecific factors . BDI = Beck Depression Inventory ; CI = confidence interval ; HAM-D = Hamilton Depression Rating Scale ; ITT = intention-to-treat ; MDD = major depressive disorder ; SD = st and ard deviation ; SSRIs = selective serotonin reuptake inhibitors ; TSH = thyroid stimulating hormone The author investigated whether expressive writing enhances emotional adaptation to a stressful event ( graduate entrance exams ) by reducing event-related intrusive thoughts or by desensitizing people to such thoughts . Participants in the experimental group , who were instructed to write their deepest thoughts and feelings about the exam , exhibited a significant decline in depressive symptoms from 1 month ( Time 1 ) to 3 days ( Time 2 ) before the exam . Participants in the control group , who wrote about a trivial topic , maintained a relatively high level of depressive symptoms over this same period . Expressive writing did not affect the frequency of intrusive thoughts , but it moderated the impact of intrusive thoughts on depressive symptoms . Specifically , intrusive thoughts at Time 1 were positively related to depressive symptoms at Time 2 in the control group and were unrelated to symptoms in the expressive writing group Objective : To compare the effects of aerobic and resistance exercise on weight , muscle strength , cardiovascular fitness , blood pressure and mood in obese women who were not on an energy-restricted diet . Design : R and omized , prospect i ve , controlled trial . Setting : Department of Physical Medicine and Rehabilitation , University Hospital . Subjects : Sixty obese women were assigned to one of three groups : aerobic exercise ( n=20 ) , resistance exercise ( n=20 ) and control group ( n=20 ) . Interventions : The aerobic exercise group performed both walking and leg cycle exercise with increasing duration and frequency . The resistance exercise group performed progressive weight-resistance exercises for the upper and lower body . Main outcome measures : Before and after a 12-week period , all subjects were evaluated by anthropometric measurement , rating of mood , cardiorespiratory capacity and maximum strength of trained muscles . Results : After a 12-week training period , subjects in the resistance group showed significant improvement in one-repetition maximum test of hip abductors ( 7.95±3.58 kg ) , quadriceps ( 14±7.18 kg ) , biceps ( 3.37± 2.84 kg ) and pectorals ( 8.75±5.09 kg ) compared with those in the control group ( P<0.001 ) . VO2 max increased ( 0.51±0.40 ) and Beck Depression Scale scores decreased ( -5.40±4.27 ) in the aerobic exercise group compared with the control group , significantly ( P<0.001 ) . Only in hip abductor muscle strength was there a significant increase in the resistance exercise group compared with the aerobic exercise group ( P < 0.05 ) . Conclusion : Both aerobic exercise and resistance exercise result ed in improved performance and exercise capacity in obese women . While aerobic exercise appeared to be beneficial with regard to improving depressive symptoms and maximum oxygen consumption , resistance exercise was beneficial in increasing muscle strength OBJECTIVE To evaluate the feasibility of 8 months of supervised exercise therapy in warm water and its effects on the impact of fibromyalgia on physical and mental health and physical fitness in affected women . METHODS Thirty women with fibromyalgia were r and omly assigned to an exercise therapy group ( n = 15 ) or a control group ( inactive ) ( n = 15 ) . The impact of fibromyalgia on physical and mental health was assessed using the Fibromyalgia Impact Question naire and the anxiety state with State-Trait Anxiety Inventory . Physical fitness was measured using the following tests : Canadian Aerobic Fitness ; h and -grip dynamometry ; 10-metre walking ; 10-step stair-climbing and blind 1-leg stance . RESULTS After 8 months of training , the exercise therapy group improved compared with the control group in terms of physical function ( 20 % ) , pain ( 8 % ) , stiffness ( 53 % ) , anxiety ( 41 % ) , depression ( 27 % ) , Fibromyalgia Impact Question naire total scores ( 18 % ) , State-Trait Anxiety Inventory score ( 22 % ) , aerobic capacity ( 22 % ) , balance ( 30 % ) , functional capacity for walking ( 6 % ) , stair-climbing with no extra weight ( 14 % ) and stair-climbing 10 kg-weighted ( 25 % ) . CONCLUSION Eight months of supervised exercise in warm water was feasible and led to long-term improvements in physical and mental health in patients with fibromyalgia at a similar magnitude to those of shorter therapy programmes PURPOSE This study was design ed to determine if a single bout of moderate-intensity aerobic exercise would improve mood and well-being in 40 ( 15 male , 25 female ) individuals who were receiving treatment for major depressive disorder ( MDD ) . METHODS All participants were r and omly assigned to exercise at 60 - 70 % of age-predicted maximal heart rate for 30 min or to a 30-min period of quiet rest . Participants completed both the Profile of Mood States ( POMS ) and Subjective Exercise Experiences Scale ( SEES ) as indicators of mood 5 min before , and 5 , 30 , and 60 min following their experimental condition . RESULTS Both groups reported similar reductions in measures of psychological distress , depression , confusion , fatigue , tension , and anger . Only the exercise group , however , reported a significant increase in positive well-being and vigor scores . CONCLUSION Although 30 min of either moderate-intensity treadmill exercise or quiet rest is sufficient to improve the mood and well-being of patients with MDD , exercise appears to have a greater effect on the positively valenced states measured Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment . Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population , but this has not yet been tested in a r and omized clinical trial . Methods and design This r and omized clinical trial will examine whether behavior therapy for depression administered prior to st and ard weight loss treatment produces greater weight loss than st and ard weight loss treatment alone . Obese women with major depressive disorder ( N = 174 ) will be recruited from primary care clinics and the community and r and omly assigned to one of the two treatment conditions . Treatment will last 2 years , and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase . Follow-up assessment will occur at 6-months and 1- and 2 years following r and omization . The primary outcome is weight loss . The study was design ed to provide 90 % power for detecting a weight change difference between conditions of 3.1 kg ( st and ard deviation of 5.5 kg ) at 1-year assuming a 25 % rate of loss to follow-up . Secondary outcomes include depression , physical activity , dietary intake , psychosocial variables and cardiovascular risk factors . Potential mediators ( e.g. , adherence , depression , physical activity and caloric intake ) of the intervention effect on weight change will also be examined . Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes .Trial registration Abstract While antidepressant medications and electroconvulsive therapy have been shown to be effective treatments for severe depression , mild and moderate depressions seldom respond to medications and are usually managed by a variety of psychotherapies , all of which are equally and minimally beneficial . Clinical experience suggested that physical activity might be helpful in treating moderate depression . After review ing the available literature ( analogue studies suggested a negative correlation between exercise and depression ) , we conducted a clinical study comparing a 10 week course of thrice weekly walking-jogging-running with 10 weeks of two different psychotherapies . Patients with moderate ( “ neurotic-reactive ” ) depression were r and omly assigned to the three treatments . Walking-jogging-running was at least as effective as either psychotherapy and cost a quarter as much to adminster . Follow-up shows continued freedom from depression in runners , most of whom have continued the treatment on their own . Possible mechanisms of reaction will be discussed OBJECTIVE The Regenerate pilot study explored whether a 10-week , community-based progressive resistance training ( PRT ) program could reduce depressive symptoms in depressed chronic stroke survivors . METHODS Participants were screened for depressive status using the PHQ-9 and confirmed by psychiatric assessment . Eligible people ( n = 45 ) were r and omised to PRT or a waiting-list comparison group . The PRT program included two high intensity sessions/week for 10 weeks at a community-based gymnasium . Depressive status , physical and mental health and quality of life were measured at baseline , 10 weeks and 6 months . Muscle strength was assessed using 1 repetition maximum ( 1-RM ) for upper and lower limbs . RESULTS The participants ' median age was 69 years : 27 were male . The intervention group had lower depression scores than the comparison group at all time points . At 6-month follow-up , there was a trend for PRT participants to be more likely to be no longer depressed than the comparison group , but the difference was not significant after adjusting for baseline scores . There were modest improvements in health and wellbeing over time , but many scores were lower than reported in non-depressed people . Intervention participants demonstrated significant improvements in strength . Program adherence was good : on average 75 % of the 10-week program was completed . CONCLUSIONS The intervention appeared to be feasible within a community-based setting . To optimize stroke recovery and improve the quality of life of stroke survivors , health professionals should continue to focus on helping survivors ' mental health recovery as well their physical rehabilitation We tested the hypothesis that exercise would improve subjective sleep quality and activity in depressed elders . A 10-week r and omized controlled trial was utilized . Participants consisted of a volunteer sample , aged > 60 with a diagnosis of major or minor depression or dysthymia . A total of 32 subjects aged 60 - 84 years with a mean age of 71.3 + /- 1.2 years was used . Intervention consisted of a supervised weight-training program three times a week or an attention-control group . Main outcome measures were Pittsburgh Subjective Sleep Quality Index ( PSQI ) , Likert Scale of Subjective Sleep Quality and Quantity . Paffenbarger Activity Index . Geriatric Depression Scale ( GDS ) . Beck Depression Inventory ( BDI ) , Hamilton Rating Scale of Depression ( HRSD ) , and the Medical Outcomes Survey Short Form 36 ( SF-36 ) . Results showed that exercise significantly improved all subjective sleep- quality and depression measures . Depression measures were reduced by approximately twice that of controls . Habitual activity was not significantly increased by exercise . Quality of life subscales significantly improved . In a forward stepwise multiple regression , percent improvement in GDS and percent increase in strength remained significant predictors of the improvement in total PSQI score ( r = 0.71 , p = 0.0002 ) . In conclusion , weight lifting exercise was effective in improving subjective sleep quality , depression , strength , and quality of life without significantly changing habitual activity OBJECTIVE The TREAting Depression with physical activity ( TREAD ) study investigated the cost-effectiveness of a physical activity intervention , in addition to usual general practitioner care , as a treatment for people with depression . DESIGN An individually r and omised , pragmatic , multicentre r and omised controlled trial with follow-up at 4 , 8 and 12 months . A subset of participants took part in a qualitative study that investigated the acceptability and perceived benefits of the intervention . SETTING General practice s in the Bristol and Exeter areas . PARTICIPANTS Aged 18 - 69 years with an International Statistical Classification of Diseases and Related Health Problems , 10th Edition ( ICD-10 ) diagnosis of depression and scoring ≥ 14 on the Beck Depression Inventory ( BDI ) . Those who were unable to complete self-administered question naires in English , with medical contraindications to physical activity or with psychosis , bipolar disorder or serious drug abuse were excluded . INTERVENTIONS We devised an intervention design ed to encourage choice and autonomy in the adoption of physical activity . It consisted of up to three face-to-face and ten telephone contacts delivered by a trained physical activity facilitator over an 8-month period . MAIN OUTCOME MEASURES The primary outcome was the BDI score measured at 4 months . Secondary outcomes included depressive symptoms over the 12 months and quality of life , antidepressant use and level of physical activity . RESULTS The study recruited 361 patients , with 182 r and omised to the intervention arm and 179 to the usual care arm ; there was 80 % retention at the 4-month follow-up . The intervention group had a slightly lower BDI score at 4 months [ -0.54 , 95 % confidence interval ( CI ) -3.06 to 1.99 ] but there was no evidence that the intervention improved outcome for depression . Neither was there any evidence to suggest a difference in the prescription of or self-reported use of antidepressants . However , the amount of physical activity undertaken by those who had received the intervention was increased ( odds ratio 2.3 , 95 % CI 1.3 to 3.9 ) and was sustained beyond the end of the intervention . From a health-care perspective , the intervention group was more costly than the usual care group , with the cost of the intervention £ 220 per person on average . It is therefore extremely unlikely that the intervention is cost-effective as a treatment for depression using current willingness-to-pay thresholds . CONCLUSIONS This physical activity intervention is very unlikely to lead to any clinical benefit in terms of depressive symptoms or to be a cost-effective treatment for depression . Previous research has reported some benefit and there are three possible reasons for this discrepancy : first , even though the intervention increased self-reported physical activity , the increase in activity was not sufficiently large to lead to a measurable influence ; second , only more vigorous activity might be of benefit ; and third , previous studies had recruited individuals with a pre-existing commitment to physical activity . Future research is needed to identify and explain the mechanisms by which depression might be effectively treated , including , in particular , specific guidance on the optimum type , intensity and duration of physical activity required to produce a therapeutic effect . TRIAL REGISTRATION Current Controlled Trials IS RCT N16900744 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 16 , No. 10 . See the HTA programme website for further project information Purpose : Exercise has been put forward as a therapeutic means for the treatment of clinical depression . Methods : In this study , 29 patients , all with diagnosed with mood disorder , completed daily measurements of depression and physical well-being during periods ranging from 77 to 436 days ( M = 146.5 ) . Fitness training was added to the treatment after a period and changes before ( A-phase ) and after ( B-phase ) the implementation of this training were the subject of investigation . Data were analysed by means of r and omization tests with an AB- design and time-series analysis . Replication of the findings was investigated using Fisher 's multiplicative method . Results : Adding fitness training to the treatment of clinical depression does not systematic ally lead to changes in self-reported feelings of depression on top of benefits that may be due to other treatments . Conclusion : Since the present findings are not in agreement with previous studies , the absence of statistically significant changes in self-reported feelings of depression is discussed within the complexity of the ‘ exercise – depression ’ relationship in inpatient population s. These included the severity of their depression , the potential ceiling effect of a multifaceted treatment programme and the initial increase in depression due to the confrontational nature of the intervention AIM One of the major treatment goals in congestive heart failure ( CHF ) is to preserve the functional level of the patient and to improve psychosocial factors . For these purpose s , exercise training is recommended for the management of CHF . With this background , the aim of this study is to investigate the effects of aerobic exercise on quality of life , depression and anxiety levels in a Turkish patient population with CHF . METHODS Sixty patients with CHF in stage II-III according to NYHA were included . Patients were r and omly assigned either to a cardiac rehabilitation group or to a control group . Twenty-seven patients were allocated to a weekly aerobic walking program on treadmill , thrice a week for 8 weeks , and 26 patients did not receive any exercise training . Both groups were assessed by an ergospirometric exercise test , Hacettepe Quality of Life Question naire ( HQoL ) , Beck Depression Inventory ( BDI ) , Spielberger Trait Anxiety Inventory ( STAI ) at baseline and at the end . RESULTS Forty-four patients ( treatment group : 23 ) completed the study . In the treatment group , significant increases in peak oxygen consumption , exercise time and metabolic equivalents ( MET ) levels were attained ( P=0.001 , P=0.001 , P=0.003 , respectively ) . Significant decreases in BDI ( P=0.004 ) and STAI subgroups ( P=0.049 , P=0.023 , respectively ) were observed , whereas there was no change in HQoL scores . In the control group , there was no difference between baseline and 8th week evaluation in all parameters . CONCLUSIONS Patients with CHF tolerated aerobic exercise programs well . This result ed with improvement in both physical and psychologic wellbeing , but not in quality of life in the short term OBJECTIVES To describe the effects of a health advocacy , counselling , and activation programme on depressive symptoms among older coronary heart disease ( CHD ) patients . METHODS A r and omised , controlled intervention study in Lieto , South-western Finl and . Older ( 65 years and older ) patients with CHD were r and omly divided into an intervention group ( IG ) ( n = 116 ) and a control group ( CG ) ( n = 106 ) . Outcome measures comprised changes in depressive symptoms ( Zung Self-rating Depression Scale , ZSDS ) . RESULTS Depressive symptoms tended to decrease in IG and to increase in CG among men scoring 45 ZSDS sum points or more at baseline . The differences of the changes between IG and CG were significant in favour of IG . No similar changes were found among women . CONCLUSIONS A health advocacy , counselling , and activation programme aim ed to increase knowledge about CHD , social activities , contacts , roles , support , and exercising was effective in reducing depressive symptoms among male CHD patients suffering from a moderate or high amount of depressive symptoms OBJECTIVES To determine whether the presence of high depressive symptoms ( Center for Epidemiologic Studies Depression Scale ( CES-D ) score ≥ 14 ) diminished physical performance benefits after a comprehensive physical activity intervention in older adults . DESIGN A post hoc analysis of data from the Lifestyle Interventions and Independence for Elders Pilot ( LIFE-P ) study , a single-blind r and omized controlled trial comparing a moderate-intensity physical activity intervention ( PA ) with a successful aging control ( SA ) . SETTING Multicenter U.S. institutions participating in the LIFE-P trial . PARTICIPANTS Four hundred twenty-four sedentary , noninstitutionalized adults aged 70 to 89 . MEASUREMENTS Depressive symptoms were assessed using the CES-D. Physical performance tests included the Short Physical Performance Battery ( SPPB ) and 400-m walk time ( 400 mw ) at baseline and 6 and 12 months . RESULTS Of the participants , 15.8 % had high depressive symptom scores ( CES-D ≥ 14 ) . For participants with low depressive symptoms , SPPB scores improved more in the PA than the SA group over 12 months ( adjusted score difference + 0.70 ; P < .001 at 6 months and + 0.58 ; P = .004 at 12 months ) , and 400 mw times improved in the PA group at 6 months ( adjusted score difference -0.41 minutes ; P = .02 ) . For participants with high depressive symptoms , the difference in improvement fell short of statistical significance on the SPPB between the PA and SA groups ( adjusted score difference + 0.76 ( P = .18 ) at 6 months and + 0.94 ( P = .12 ) at 12 months ) . CONCLUSION The presence of high depressive symptoms did not substantially diminish physical performance benefits realized after a PA intervention in sedentary older adults This preliminary study tested the effects of a home-based walking intervention on total sleep time ( TST ) , nocturnal awakenings , depressive symptoms , physical function , and quality of life ( QOL ) in older women with diastolic heart failure ( DHF ) . Twenty-three women ( mean age , 68+/-11 years ) with New York Heart Association class II or III DHF were r and omized to either a 12-week home-based walking intervention ( n=13 ) or education-only program ( control , n=10 ) . No between-group differences were found in women in the intervention and control groups on any of the outcome variables . When outcomes were compared within each group at baseline and 12 weeks , intervention-group patients had improvement in TST ( P<.01 ) and heart failure-related QOL ( P<.05 ) and a trend for decreased depressive symptoms ( P<.07 ) . Women r and omized to the control group had no change in any outcomes . These preliminary findings suggest that a progressive walking program may improve TST and QOL in older women with DHF . Findings from this study support the need for larger studies to evaluate the long-term benefits of a walking program on sleep patterns , QOL , and psychologic function in this population Background : Few exercise trials in cancer patients have reported longer-term follow-up . Here , we report a 6-month follow-up of exercise behavior and patient-rated outcomes from an exercise trial in breast cancer patients . Methods : Breast cancer patients initiating adjuvant chemotherapy ( n = 242 ) were r and omly assigned to usual care ( n = 82 ) , resistance exercise training ( RET ; n = 82 ) , or aerobic exercise training ( AET ; n = 78 ) for the duration of their chemotherapy . At 6-month follow-up , participants were mailed a question naire that assessed quality of life , self-esteem , fatigue , anxiety , depression , and exercise behavior . Results : Two hundred one ( 83.1 % ) participants provided 6-month follow-up data . Adjusted linear mixed-model analyses showed that , at 6-month follow-up , the RET group reported higher self-esteem [ adjusted mean difference , 1.6 ; 95 % confidence interval ( 95 % CI ) , 0.1 - 3.2 ; P = 0.032 ] and the AET group reported lower anxiety ( adjusted mean difference , −4.7 ; 95 % CI , −0.0 to −9.3 ; P = 0.049 ) compared with the usual care group . Moreover , compared with participants reporting no regular exercise during the follow-up period , those reporting regular aerobic and resistance exercise also reported better patient-rated outcomes , including quality of life ( adjusted mean difference , 9.5 ; 95 % CI , 1.2 - 17.8 ; P = 0.025 ) . Conclusions : Improvements in self-esteem observed with RET during breast cancer chemotherapy were maintained at 6-month follow-up whereas reductions in anxiety not observed with AET during breast cancer chemotherapy emerged at 6-month follow-up . Moreover , adopting a combined aerobic and resistance exercise program after breast cancer chemotherapy was associated with further improvements in patient-rated outcomes . Exercise training during breast cancer chemotherapy may result in some longer-term and late effects for selected patient-rated outcomes . ( Cancer Epidemiol Biomarkers Prev 2007;16(12):2572–8 OBJECTIVE Most patients with major depressive disorder ( MDD ) require second-step treatments to achieve remission . The Treatment with Exercise Augmentation for Depression ( TREAD ) study was design ed to test the efficacy of aerobic exercise as an augmentation treatment for MDD patients who had not remitted with antidepressant treatment . METHOD Eligible participants in this r and omized controlled trial were sedentary individuals ( men and women aged 18 - 70 years ) diagnosed with DSM-IV nonpsychotic MDD who had not remitted with selective serotonin reuptake inhibitor ( SSRI ) treatment . Participants were recruited through physician referrals and advertisements . A total of 126 participants were r and omized to augmentation treatment with either 16 kcal per kg per week ( KKW ) or 4 KKW of exercise expenditure for 12 weeks while SSRI treatment was held constant . Supervised sessions were conducted at The Cooper Institute , Dallas , Texas , with additional home-based sessions as needed to fulfill the weekly exercise prescription . The primary outcome was remission ( as determined by a score ≤ 12 on the Inventory of Depressive Symptomatology , Clinician-Rated ) . The study took place between August 2003 and August 2007 . RESULTS There were significant improvements over time for both groups combined ( F₁,₁₂₁ = 39.9 , P < .0001 ) , without differential group effect ( group effect : F₁,₁₃₄ = 3.2 , P = .07 ; group-by-time effect : F₁,₁₁₉ = 3.8 , P = .06 ) . Adjusted remission rates at week 12 were 28.3 % versus 15.5 % for the 16-KKW and 4-KKW groups , respectively , leading to a number needed to treat ( NNT ) of 7.8 for 16 KKW versus 4 KKW . Men , regardless of family history of mental illness , and women without a family history of mental illness had higher remission rates by week 12 with higher-dose ( women , 39.0 % ; men , 85.4 % ) than with lower-dose exercise ( women , 5.6 % ; men , 0.1 % ) ( women : t₉₅ = 2.1 , P = .04 ; men : t₈₈ = 5.4 , P < .0001 ) ( NNT : women , 3.0 ; men , 1.2 ) . CONCLUSIONS There was a trend for higher remission rates in the higher-dose exercise group ( P < .06 ) , with a clinical ly meaningful NNT of 7.8 in favor of the high exercise dose . Significant differences between groups were found when the moderating effects of gender and family history of mental illness were taken into account and suggest that higher-dose exercise may be better for all men and for women without a family history of mental illness . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00076258 OBJECTIVES To evaluate whether age , sex , depression , dementia disorder , nutritional status , or level of functional balance capacity influences the effect of a high-intensity functional weight-bearing exercise program on functional balance . DESIGN Preplanned subgroup analyses of a r and omized controlled trial . SETTING Nine residential care facilities . PARTICIPANTS One hundred ninety-one people aged 65 to 100 dependent in activities of daily living and with Mini-Mental State Examination scores of 10 or greater . INTERVENTION A high-intensity functional weight-bearing exercise program or a control activity , each comprising 29 sessions over 3 months . MEASUREMENTS Functional balance capacity was assessed blindly using the Berg Balance Scale ( BBS ) at baseline , 3 months , and 6 months . The BBS consists of 14 tasks , common in everyday life , such as st and ing up from sitting and , while st and ing , reaching forward or turning 360 ° . Interactions between allocation to activity group and each subgroup were evaluated according to the intention-to-treat principle . RESULTS The subgroup analyses revealed no statistically significant interaction for age , sex , depression , dementia disorder , nutritional status , or level of functional balance capacity at 3 ( P=.65 , .65 , .51 , .78 , .09 , .67 , respectively ) or 6 ( P=.69 , .62 , .20 , .94 , .48 , .85 , respectively ) months . In addition , at 3 and 6 months there was no significant interaction for cognitive level ( P=.28 , .47 , respectively ) or number of depressive symptoms ( P=.85 , .49 , respectively ) . CONCLUSION Older age , female sex , depression , mild to moderate dementia syndrome , malnutrition , and severe physical impairment do not seem to have a negative effect on functional balance from a high-intensity functional weight-bearing exercise program . Consequently , people with these characteristics in residential care facilities should not be excluded from offers of rehabilitation including high-intensity exercises Phone and Internet-based interventions can improve the management of depression in primary care , and interventions using these communication channels are increasingly used to improve behaviors such as diet and physical activity . Increased physical activity has been shown to improve depressive symptoms , but to date there are no reports of the effects of a phone and Internet diet and exercise intervention on symptoms of depression in patients seen in primary care . This study assessed depressive symptoms in 401 participants in a r and omized control trial of a 12-month primary care , phone and Internet-based behavioral intervention for overweight women . A one-way analysis of variance examining the mean change in Center for Epidemiological Studies Depression ( CESD ) score from baseline to 12 months , controlling for age , education , marital status , and employment showed that those receiving the intervention significantly decreased their CESD scores ( P=.03 ) more than those receiving st and ard care . Although the intervention did not target depressed individuals or present material relating to mood management , those with probable depression ( 27 % of the whole sample ) showed clinical ly important improvements-a mean five-point change on the CESD short form . Participants who engaged more readily with the intervention were more likely to reduce their depression scores . A 1-year primary care based phone and Internet diet and exercise intervention can improve depressive symptoms in overweight women . Given the promise of phone and Internet-based interventions to improve both depression and lifestyle-related behaviors , and given that such interventions could extend the reach of primary care to many individuals at relatively low cost , these results suggest the need for further research , including the effects of additional mood management components BACKGROUND Season-related subsyndromal depressive symptoms during winter are common among population s at high latitudes . Both physical exercise and exposure to bright light can relieve the fatigue and downturn of mood associated with the shortening length of day . Serum cholesterol level may be related to changes in mood , but the evidence is contradictory . Our objective was to compare the effect of aerobic exercise with or without bright-light exposure on health-related quality of life , mood , and serum lipids in a sample of relatively healthy adult subjects . METHOD A r and omized controlled trial was conducted with subjects allocated to group aerobics training in a gym with bright light ( 2500 - 4000 lux ) ( N = 40 ) or normal illumination ( N = 42 ) or to relaxation/stretching sessions in bright light as a control group ( N = 42 ) twice a week for a period of 8 weeks . Changes in mood were recorded using question naires at the beginning of the study , at weeks 4 and 8 . and at follow-up 4 months after the study . A blood sample was drawn before and after the 8-week intervention to measure the concentrations of serum lipids . RESULTS Ninety-eight subjects completed the 8-week study . Both exercise and bright light effectively relieved depressive symptoms . Bright light reduced atypical depressive symptoms more than exercise ( p = .03 ) , based on the atypical symptoms subscore of the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorders Version Self-Rating Format . There were no significant differences between the study groups in the changes in serum lipid levels . CONCLUSION Bright light administered twice a week , alone or combined with physical exercise , seems to be a useful intervention for relieving seasonal mood slumps Objective : To examine a 1-year follow-up of a 4-month , controlled clinical trial of exercise and antidepressant medication in patients with major depressive disorder ( MDD ) . Methods : In the original study , 202 sedentary adults with MDD were r and omized to : a ) supervised exercise ; b ) home-based exercise ; c ) sertraline ; or d ) placebo pill . We examined two outcomes measured at 1-year follow-up ( i.e. , 16 months post r and omization ) : 1 ) continuous Hamilton Depression Rating Scale score ; and 2 ) MDD status ( depressed ; partial remission ; full remission ) in 172 available participants ( 85 % of the original cohort ) . Regression analyses were performed to examine the effects of treatment group assignment , as well as follow-up antidepressant medication use and self-reported exercise ( Godin Leisure-Time Exercise Question naire ) , on the two outcomes . Results : In the original study , patients receiving exercise achieved similar benefits compared with those receiving sertraline . At the time of the 1-year follow-up , rates of MDD remission increased from 46 % at post treatment to 66 % for participants available for follow-up . Neither initial treatment group assignment nor antidepressant medication use during the follow-up period were significant predictors of MDD remission at 1 year . However , regular exercise during the follow-up period predicted both Hamilton Depression Rating Scale scores and MDD diagnosis at 1 year . This relationship was curvilinear , with the association concentrated between 0 minute and 180 minutes of weekly exercise . Conclusion : The effects of aerobic exercise on MDD remission seem to be similar to sertraline after 4 months of treatment ; exercise during the follow-up period seems to extend the short-term benefits of exercise and may augment the benefits of antidepressant use . Trial Registration : clinical trials.gov Identifier : NCT00331305 . MDD = major depressive disorder ; HAM-D = Hamilton Depression Rating Scale ; SCID = Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition Axis I Disorders ; PSSS = Perceived Social Support Scale A 12-week r and omized controlled trial was conducted ( n = 20 ) investigating the effects of a multi-intervention programme of exercise and social support compared to a control group . Both groups had given birth in the past 12 months and were experiencing depressive symptomatology . Pretest data of physical fitness and structured question naires were compared to post-test data . The results from the study showed that mothers who were in the multi-intervention group improved their fitness levels and depressive symptomatology significantly more than the control group . However , there were no significant changes to either group 's social support levels . These results are encouraging and suggest that a pram push walking intervention might be an effective treatment for mothers suffering postnatal distress BACKGROUND Laughter Yoga founded by M. Kataria is a combination of unconditioned laughter and yogic breathing . Its effect on mental and physical aspects of healthy individuals was shown to be beneficial . OBJECTIVE The objective of this study was to compare the effectiveness of Kataria 's Laughter Yoga and group exercise therapy in decreasing depression and increasing life satisfaction in older adult women of a cultural community of Tehran , Iran . METHODS Seventy depressed old women who were members of a cultural community of Tehran were chosen by Geriatric depression scale ( score>10 ) . After completion of Life Satisfaction Scale pre-test and demographic question naire , subjects were r and omized into three groups of laughter therapy , exercise therapy , and control . Subsequently , depression post-test and life satisfaction post-test were done for all three groups . The data were analyzed using analysis of covariance and Bonferroni 's correction . RESULTS Sixty subjects completed the study . The analysis revealed a significant difference in decrease in depression scores of both Laughter Yoga and exercise therapy group in comparison to control group ( p<0.001 and p<0.01 , respectively ) . There was no significant difference between Laughter Yoga and exercise therapy groups . The increase in life satisfaction of Laughter Yoga group showed a significant difference in comparison with control group ( p<0.001 ) . No significant difference was found between exercise therapy and either control or Laughter Yoga group . CONCLUSION Our findings showed that Laughter Yoga is at least as effective as group exercise program in improvement of depression and life satisfaction of elderly depressed women This r and omised trial compared the effects of Brain Wave Vibration ( BWV ) training , which involves rhythmic yoga-like meditative exercises , with Iyengar yoga and Mindfulness . Iyengar provided a contrast for the physical components and mindfulness for the “ mental ” components of BWV . 35 healthy adults completed 10 75-minute classes of BWV , Iyengar , or Mindfulness over five weeks . Participants were assessed at pre- and postintervention for mood , sleep , mindfulness , absorption , health , memory , and salivary cortisol . Better overall mood and vitality followed both BWV and Iyengar training , while the BWV group alone had improved depression and sleep latency . Mindfulness produced a comparatively greater increase in absorption . All interventions improved stress and mindfulness , while no changes occurred in health , memory , or salivary cortisol . In conclusion , increased well-being followed training in all three practice s , increased absorption was specific to Mindfulness , while BWV was unique in its benefits to depression and sleep latency , warranting further research Objectives To determine functional and psychological benefits of a 12 week supervised group exercise programme during treatment for early stage breast cancer , with six month follow-up . Design Pragmatic r and omised controlled prospect i ve open trial . Setting Three National Health Service oncology clinics in Scotl and and community exercise facilities . Participants 203 women entered the study ; 177 completed the six month follow-up . Interventions Supervised 12 week group exercise programme in addition to usual care , compared with usual care . Main outcome measures Functional assessment of cancer therapy ( FACT ) question naire , Beck depression inventory , positive and negative affect scale , body mass index , seven day recall of physical activity , 12 minute walk test , and assessment of shoulder mobility . Results Mixed effects models with adjustment for baseline values , study site , treatment at baseline , and age gave intervention effect estimates ( intervention minus control ) at 12 weeks of 129 ( 95 % confidence interval 83 to 176 ) for metres walked in 12 minutes , 182 ( 75 to 289 ) for minutes of moderate intensity activity reported in a week , 2.6 ( 1.6 to 3.7 ) for shoulder mobility , 2.5 ( 1.0 to 3.9 ) for breast cancer specific subscale of quality of life , and 4.0 ( 1.8 to 6.3 ) for positive mood . No significant effect was seen for general quality of life ( FACT-G ) , which was the primary outcome . At the six month follow-up , most of these effects were maintained and an intervention effect for breast cancer specific quality of life emerged . No adverse effects were noted . Conclusion Supervised group exercise provided functional and psychological benefit after a 12 week intervention and six months later . Clinicians should encourage activity for their patients . Policy makers should consider the inclusion of exercise opportunities in cancer rehabilitation services . Trial registration Current controlled trials IS RCT N12587864 Background Depression is one of the most common reasons for consulting a General Practitioner ( GP ) within the UK . Whilst antidepressants have been shown to be clinical ly effective , many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression . A recent systematic review presented some evidence that physical activity could offer one such option , although further investigation is needed to test its effectiveness within the context of the National Health Service . The aim of this paper is to describe the protocol for a r and omised , controlled trial ( RCT ) design ed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care . Methods / design The TREAD study is a pragmatic , multi-centre , two-arm RCT which targets patients presenting with a new episode of depression . Patients were approached if they were aged 18 - 69 , had recently consulted their GP for depression and , where appropriate , had been taking antidepressants for less than one month . Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised ( CIS-R ) , a Beck Depression Inventory ( BDI ) score of at least 14 and informed written consent were included in the study . Eligible patients were individually r and omised to one of two treatment groups ; usual GP care or usual GP care plus facilitated physical activity . The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after r and omisation . A number of secondary outcomes are also measured at the 4- , 8- and 12-month follow-up points including quality of life , attitude to and involvement in physical activity and antidepressant use/adherence . Outcomes will be analysed on an intention-to-treat ( ITT ) basis and will use linear and logistic regression models to compare treatments . Discussion The results of the trial will provide information about the effectiveness of physical activity as a treatment for depression . Given the current prevalence of depression and its associated economic burden , it is hoped that TREAD will provide a timely contribution to the evidence on treatment options for patients , clinicians and policy-makers . Trial registration : IS RCT N CONTEXT Depression is common in patients with cardiac disease , especially in patients with heart failure , and is associated with increased risk of adverse health outcomes . Some evidence suggests that aerobic exercise may reduce depressive symptoms , but to our knowledge the effects of exercise on depression in patients with heart failure have not been evaluated . OBJECTIVE To determine whether exercise training will result in greater improvements in depressive symptoms compared with usual care among patients with heart failure . DESIGN , SETTING , AND PARTICIPANTS Multicenter , r and omized controlled trial involving 2322 stable patients treated for heart failure at 82 medical clinical centers in the United States , Canada , and France . Patients who had a left ventricular ejection fraction of 35 % or lower , had New York Heart Association class I to IV heart failure , and had completed the Beck Depression Inventory II ( BDI-II ) score were r and omized ( 1:1 ) between April 2003 and February 2007 . Depressive scores ranged from 0 to 59 ; scores of 14 or higher are considered clinical ly significant . INTERVENTIONS Participants were r and omized either to supervised aerobic exercise ( goal of 90 min/wk for months 1 - 3 followed by home exercise with a goal of ≥120 min/wk for months 4 - 12 ) or to education and usual guideline -based heart failure care . MAIN OUTCOME MEASURES Composite of death or hospitalization due to any cause and scores on the BDI-II at months 3 and 12 . RESULTS Over a median follow-up period of 30 months , 789 patients ( 68 % ) died or were hospitalized in the usual care group compared with 759 ( 66 % ) in the aerobic exercise group ( hazard ratio [ HR ] , 0.89 ; 95 % CI , 0.81 to 0.99 ; P = .03 ) . The median BDI-II score at study entry was 8 , with 28 % of the sample having BDI-II scores of 14 or higher . Compared with usual care , aerobic exercise result ed in lower mean BDI-II scores at 3 months ( aerobic exercise , 8.95 ; 95 % CI , 8.61 to 9.29 vs usual care , 9.70 ; 95 % CI , 9.34 to 10.06 ; difference , -0.76 ; 95 % CI,-1.22 to -0.29 ; P = .002 ) and at 12 months ( aerobic exercise , 8.86 ; 95 % CI , 8.67 to 9.24 vs usual care , 9.54 ; 95 % CI , 9.15 to 9.92 ; difference , -0.68 ; 95 % CI , -1.20 to -0.16 ; P = .01 ) . CONCLUSIONS Compared with guideline -based usual care , exercise training result ed in a modest reduction in depressive symptoms , although the clinical significance of this improvement is unknown . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00047437 Background The OPERA trial is large cluster r and omised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people . A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation . Challenges included the cognitive and physical ability of the participants , the need to respect the privacy of all home residents , including study non- participants , and the physical structure of the homes . Evaluation activity had to be organised around the structured timetable of homes , leaving limited opportunities for data collection . The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results , and to inform potential implementation of the physical activity intervention on a wider scale . Methods / design Quantitative data on recruitment of homes and individuals is being collected . For homes in the intervention arm , data on dose and fidelity of the intervention delivered ; including individual rates of participation in exercise classes are collected . In the control homes , uptake and delivery of depression awareness training is monitored . These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes ( six intervention and two control ) . Discussion Although process evaluations are increasingly funded alongside trials , it is still rare to see the findings published , and even rarer to see the protocol for such an evaluation published . Process evaluations have the potential to assist in interpreting and underst and ing trial results as well as informing future roll-outs of interventions . If such evaluations are funded they should also be reported and review ed in a similar way to the trial outcome evaluation . Trial Registration IS RCT N No : IS RCT OBJECTIVES This report released findings of a r and omized controlled trial conducted in Hong Kong to further our underst and ing of the psychosocial effects of qigong on elderly persons with depression . DESIGN Eighty-two participants with a diagnosis of depression or obvious features of depression were recruited and r and omly assigned into the intervention and comparison group . The intervention group was given a 16-week period of Qigong practice while the comparison group participated in a newspaper reading group with same duration and frequency . RESULTS After eight weeks of qigong practice , the intervention group participants outstripped themselves in improvement in mood , self-efficacy and personal well being , and physical and social domains of self-concept when compared with comparison subjects . After 16 weeks of practice , the improvement generalized to the daily task domain of the self-concept . CONCLUSIONS This report shows that regular qigong practice could relieve depression , improve self-efficacy and personal well being among elderly persons with chronic physical illness and depression Background Despite recent advancements in the pharmacological treatment of major depressive disorder ( MDD ) , over half of patients who receive treatment with antidepressant medication do not achieve full remission of symptoms . There is evidence that exercise can reduce depressive symptomatology when used as a treatment for MDD . However , no r and omized controlled trials have evaluated exercise as an augmentation strategy for patients with carefully diagnosed MDD who remain symptomatic following an adequate acute phase trial of antidepressant therapy . Purpose TReatment with Exercise Augmentation for Depression ( TREAD ) is an NIMH-funded , r and omized , controlled trial design ed to assess the relative efficacy of two doses of aerobic exercise to augment selective serotonin reuptake inhibitor ( SSRI ) treatment of MDD . Methods The TREAD study includes 12 weeks of acute phase treatment with a 12-week post-treatment follow-up . In addition to looking at change in depressive symptoms as a primary outcome , it also includes comprehensive assessment of psychosocial function and treatment adherence . Results This paper review s the rationale and design of TREAD and illustrates how we address several key issues in contemporary patient-oriented research on MDD : 1 ) the use of augmentation strategies in the treatment of depressive disorders in general , 2 ) the use of non-pharmacological strategies in the treatment of depressive disorders , 3 ) the considerations of design ing a well-controlled trial using two active treatment groups , and 4 ) the implementation of an adherence program for the use of exercise as a treatment strategy . Conclusions The TREAD study is uniquely design ed to overcome sources of potential bias and threats to internal and external validity that have limited prior research on the mental health effects of exercise . The study is facilitated by the development of a multidisciplinary research team that includes experts in both depression treatment and exercise physiology , as well as other related fields The purpose of this study was to compare the effects of 16 weeks of a comprehensive exercise routine to supervised walking and social conversation on depression in nursing home residents with Alzheimer 's disease ( AD ) . Method : This study was a three-group , repeated- measures design with r and om assignment to treatment group . Forty-five nursing home residents with moderate to severe AD were r and omly assigned to a 16-week programme of comprehensive exercise , supervised walking or social conversation . Raters were blinded to treatment group assignment . Major outcome variables were depression measured by the Cornell Scale for Depression in Dementia , mood measured by the Dementia Mood Assessment Scale and the Alzheimer 's Mood Scale , and affect measured by the Observed Affect Scale . Depression was reduced in all three groups with some evidence of superior benefit from exercise . Depression is a common problem with serious and costly consequences for nursing home residents with AD . Exercise as a behavioural approach to treatment of depression in nursing home residents with severe AD evidence d a clear benefit to participants in this study . More research is needed to clarify the relative benefits of different types of exercise in conjunction with or without pharmacological intervention Objective : To assess the effects of intradialytic exercise training on health-related quality of life indices in haemodialysis patients . Subjects/ patients : Thirty-five patients on haemodialysis , with a mean ( SD ) age of 48.8 ( 13.9 ) years , volunteered to participate in the study . They were r and omized either to rehabilitation group ( group A : 19 patients ) , following a 10-month intradialytic exercise training programme or to control group ( group B : 14 patients ) . After the r and omization , two of the patients , one of each group , withdrew from the study for reasons unrelated to exercise training . Method : All patients at the beginning and the end of the study underwent clinical examination , laboratory tests and a treadmill exercise testing with spiroergometric study for the evaluation of their aerobic capacity ( Vo2peak ) . A formal psychosocial assessment , which included affective ( Beck Depression Inventory ) , health-related quality of life ( Quality of Life Index , Living Question naire of Minnesota , Life Satisfaction Index and Short Form-36 question naire ) and personality ( Eysenck Personality Question naire ) parameters , was evaluated at beginning and end of the study . The dose of erythropoietin was changed as needed , according to the level of the haemoglobin , aim ing to keep it at 11 ( 2 ) g/dL during the study . Results : Baseline values were similar between the two groups . After training in group A , Vo2peak was increased by 21.1 % ( P<0.05 ) and exercise time by 23.6 % ( P<0.05 ) . Moreover , group A showed a decrease in self-reported depression ( Beck Depression Index ) of 39.4 % ( P<0.001 ) . In addition , trained patients demonstrated a significant improvement in Quality of Life Index ( from 6.5 ( 1.8 ) to 9.0 ( 1.3 ) , P<0.001 ) and Life Satisfaction Index ( from 44.8 ( 8.6 ) to 53.0 ( 5.6 ) , P<0.001 ) , and an increase in the Physical Component Scale of the SF-36 ( from 40.5 ( 5.6 ) to 44.5 ( 5.5 ) , P<0.05 ) , while the Mental Component Scale remained unchanged . Multiple regression analysis indicated that the improvement in quality of life depended on the participation in exercise programmes , the effects of training and the reduction in the level of depression . No changes were observed in Eysenck Personality Question naire by the end of the study , while all the above parameters remained almost unchanged in the controls . Conclusion : The results demonstrated that intradialytic exercise training improves both physical functioning and psychological status in haemodialysis patients , leading to an improvement of patients ' quality of life The effects of two non-drug treatments ( physical exercise and bright light ) on mood , body weight and oxygen consumption were compared in age-matched groups of female subjects with winter depression , non-seasonal depression or without depression . It was found that oxygen consumption in the pre-treatment condition was similar in non-depressed subjects ( n=18 ) and depressed non-seasonals ( n=18 ) , while comparatively lower values were obtained in winter depression ( n=27 ) . Neither mood nor metabolic parameters changed significantly in the group of nine untreated winter depressives . One week of physical exercise ( 1-h pedaling on a bicycle ergometer between 13.00 and 14.00 h ) increased oxygen consumption in the group of nine winter depressives and lowered oxygen consumption in nine-subject groups of depressed and non-depressed non-seasonals . One week of bright light treatment ( 2-h exposure to 2500 lux between 14.00 and 16.00 h ) increased oxygen consumption in nine winter depressives and nine non-depressed subjects , while no significant change in oxygen consumption was found in nine subjects with non-seasonal depression . Weight loss was observed in the groups treated with physical exercise and in the group of light-treated winter depressives . Winter depression responded equally well to exercising and light , while a significant therapeutic difference in favor of exercising was found in non-seasonal depression . Overall , the results of the study suggest that energy-regulating systems are implicated in the antidepressant action of the non-drug treatments Abstract Background Depression is common in residents of Residential and Nursing homes ( RNHs ) . It is usually undetected and often undertreated . Depression is associated with poor outcomes including increased morbidity and mortality . Exercise has potential to improve depression , and has been shown in existing trials to improve outcomes among younger and older people . Existing evidence comes from trials that are short , underpowered and not from RNH setting s. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents . Method OPERA is a cluster r and omised controlled trial . RNHs are r and omised to one of two groups with interventions lasting 12 months Intervention group : a depression awareness and physical activity training session for care home staff , plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups . The intervention lasts for one year from r and omisation , or Control group : a depression awareness training session for care home staff . Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study . Our primary outcome is the prevalence of depressive symptoms , a GDS-15 score of five or more , in all participants at the end of the one year intervention period . Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to r and omisation . Other secondary outcomes include , fear of falling , mobility , fractures , pain , cognition , costs and health related quality of life . We aim ed to r and omise 77 RNHs . Discussion Home recruitment was completed in May 2010 ; 78 homes have been r and omised . Follow up will finish in May 2011 and results will be available late 2011.Trial Registration [ IS RCT N : IS RCT N43769277 Objective The purpose of this study was to assess the status of 156 adult volunteers with major depressive disorder ( MDD ) 6 months after completion of a study in which they were r and omly assigned to a 4-month course of aerobic e-ercise , sertraline therapy , or a combination of e-ercise and sertraline . Methods The presence and severity of depression were assessed by clinical interview using the Diagnostic Interview Schedule and the Hamilton Rating Scale for Depression ( HRSD ) and by self-report using the Beck Depression Inventory . Assessment s were performed at baseline , after 4 months of treatment , and 6 months after treatment was concluded ( ie , after 10 months ) . Results After 4 months patients in all three groups e-hibited significant improvement ; the proportion of remitted participants ( ie , those who no longer met diagnostic criteria for MDD and had an HRSD score < 8) was comparable across the three treatment conditions . After 10 months , however , remitted subjects in the e-ercise group had significantly lower relapse rates ( p = .01 ) than subjects in the medication group . Exercising on one ’s own during the follow-up period was associated with a reduced probability of depression diagnosis at the end of that period ( odds ratio = 0.49 , p = .0009 ) . Conclusions Among individuals with MDD , e-ercise therapy is feasible and is associated with significant therapeutic benefit , especially if e-ercise is continued over time Background The societal and personal burden of depressive illness is considerable . Despite the developments in treatment strategies , the effectiveness of both medication and psychotherapy is not ideal . Physical activity , including exercise , is a relatively cheap and non-harmful lifestyle intervention which lacks the side-effects of medication and does not require the introspective ability necessary for most psychotherapies . Several cohort studies and r and omised controlled trials ( RCTs ) have been performed to establish the effect of physical activity on prevention and remission of depressive illness . However , recent meta- analysis 's of all RCTs in this area showed conflicting results . The objective of the present article is to describe the design of a RCT examining the effect of exercise on depressive patients . Methods / Design The EFFect Of Running Therapy on Depression in adults ( EFFORT-D ) is a RCT , study ing the effectiveness of exercise therapy ( running therapy ( RT ) or Nordic walking ( NW ) ) on depression in adults , in addition to usual care . The study population consists of patients with depressive disorder , Hamilton Rating Scale for Depression ( HRSD ) ≥ 14 , recruited from specialised mental health care . The experimental group receives the exercise intervention besides treatment as usual , the control group receives treatment as usual . The intervention program is a group-based , 1 h session , two times a week for 6 months and of increasing intensity . The control group only performs low intensive non-aerobic exercises . Measurements are performed at inclusion and at 3,6 and 12 months . Primary outcome measure is reduction in depressive symptoms measured by the HRSD . Cardio-respiratory fitness is measured using a sub maximal cycling test , biometric information is gathered and blood sample s are collected for metabolic parameters . Also , co-morbidity with pain , anxiety and personality traits is studied , as well as quality of life and cost-effectiveness . Discussion Exercise in depression can be used as a st and alone or as an add-on intervention . In specialised mental health care , chronic forms of depression , co-morbid anxiety or physical complaints and treatment resistance are common . An add-on strategy therefore seems the best choice . This is the first high quality large trial into the effectiveness of exercise as an add-on treatment for depression in adult patients in specialised mental health care . Trial registration Netherl and s Trial Register ( NTR ) : PURPOSE We wanted to assess the effectiveness of a home-based physical activity program , the Depression in Late Life Intervention Trial of Exercise ( DeLLITE ) , in improving function , quality of life , and mood in older people with depressive symptoms . METHODS We undertook a r and omized controlled trial involving 193 people aged 75 years and older with depressive symptoms at enrollment who were recruited from primary health care practice s in Auckl and , New Zeal and . Participants received either an individualized physical activity program or social visits to control for the contact time of the activity intervention delivered over 6 months . Primary outcome measures were function , a short physical performance battery comprising balance and mobility , and the Nottingham Extended Activities of Daily Living scale . Secondary outcome measures were quality of life , the Medical Outcomes Study 36-item short form , mood , Geriatric Depression Scale ( GDS-15 ) , physical activity , Auckl and Heart Study Physical Activity Question naire , and self-report of falls . Repeated measures analyses tested the differential impact on outcomes over 12 months ’ follow-up . RESULTS The mean age of the participants was 81 years , and 59 % were women . All participants scored in the at – risk category on the depression screen , 53 % had a Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases , Tenth Revision diagnosis of major depression or scored more than 4 on the GDS-15 at baseline , indicating moderate or severe depression . Almost all participants , 187 ( 97 % ) , completed the trial . Overall there were no differences in the impact of the 2 interventions on outcomes . Mood and mental health related quality of life improved for both groups . CONCLUSION The DeLLITE activity program improved mood and quality of life for older people with depressive symptoms as much as the effect of social visits . Future social and activity interventions should be tested against a true usual care control Summary Background Depression is common and is associated with poor outcomes among elderly care-home residents . Exercise is a promising low-risk intervention for depression in this population . We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes . Methods We did a cluster-r and omised controlled trial in care homes in two regions in Engl and ; northeast London , and Coventry and Warwickshire . Residents aged 65 years or older were eligible for inclusion . A statistician independent of the study r and omised each home ( 1 to 1·5 ratio , stratified by location , minimised by type of home provider [ local authority , voluntary , private and care home , private and nursing home ] and size of home [ < 32 or ≥32 residents ] ) into intervention and control groups . The intervention package included depression awareness training for care-home staff , 45 min physiotherapist-led group exercise sessions for residents ( delivered twice weekly ) , and a whole home component design ed to encourage more physical activity in daily life . The control consisted of only the depression awareness training . Research ers collecting follow-up data from individual participants and the participants themselves were inevitably aware of home r and omisation because of the physiotherapists ' activities within the home . A research er masked to study allocation coded NHS routine data . The primary outcome was number of depressive symptoms on the geriatric depression scale-15 ( GDS-15 ) . Follow-up was for 12 months . This trial is registered with IS RCT N Register , number IS RCT N43769277 . Findings Care homes were r and omised between Dec 15 , 2008 , and April 9 , 2010 . At r and omisation , 891 individuals in 78 care homes ( 35 intervention , 43 control ) had provided baseline data . We delivered 3191 group exercise sessions attended on average by five study participants and five non- study residents . Of residents with a GDS-15 score , 374 of 765 ( 49 % ) were depressed at baseline ; 484 of 765 ( 63 % ) provided 12 month follow-up scores . Overall the GDS-15 score was 0·13 ( 95 % CI −0·33 to 0·60 ) points higher ( worse ) at 12 months for the intervention group compared with the control group . Among residents depressed at baseline , GDS-15 score was 0·22 ( 95 % CI −0·52 to 0·95 ) points higher at 6 months in the intervention group than in the control group . In an end of study cross-sectional analysis , including 132 additional residents joining after r and omisation , the odds of being depressed were 0·76 ( 95 % CI 0·53 to 1·09 ) for the intervention group compared with the control group . Interpretation This moderately intense exercise programme did not reduce depressive symptoms in residents of care homes . In this frail population , alternative strategies to manage psychological symptoms are required . Funding National Institute for Health Research Health Technology Assessment Background Combining bright light exposure and physical exercise may be an effective way of relieving depressive symptoms . However , relatively little is known about individual factors predicting either a good response or treatment failure . We explored background variables possibly explaining the individual variation in treatment response or failure in a r and omised trial . Methods Participants were volunteers of working-age , free from prior mental disorders and recruited via occupational health centres . The intervention was a r and omised 8-week trial with three groups : aerobics in bright light , aerobics in normal room lighting , and relaxation/stretching in bright light . Good response was defined as a 50 % decrease in the symptom score on either the Hamilton Depression Rating Scale ( HDRS ) or 8-item scale of atypical symptoms . Background variables for the analysis included sex , age , body-mass index , general health habits , seasonal pattern , and sleep disturbances . Results Complete data were received from 98 subjects ( 11 men , 87 women ) . Of them , 42 ( 5 men , 37 women ) were classified as responders on the HDRS . Overall , light had a significant effect on the number of responders , as assessed with the HDRS ( X2 = .02 ) . The number needed to treat ( NNT ) for light was 3.8 . Conclusions We investigated the effect of bright light and exercise on depressive symptoms . Problems with sleep , especially initial insomnia , may predict a good response to treatment using combined light and exercise . Bright light exposure and physical exercise , even in combination , seem to be well tolerated and effective on depressive symptoms Objective : Many studies evaluated the efficacy of exercise on some depression indices , but the effect of physical exercise in exhilarating milieu on urine 3-Methoxy-4-Hydroxyphenylglycol ( MHPG ) sulfate-the main metabolite of norepinephrine is not clear . The purpose of this research was to study the effect of a six-week intermittent walking in the water on 24-hour urine MHPG sulfate in depressed female teenagers . Methods : Twenty-four high school female students with depression were divided r and omly into case and control group . Pool walking exercise program was implemented 3 sessions weekly for 6 weeks and with a rate of 60 - 70 % of the maximum heart rate . The control group did n’t enter any exercise protocol and did not receive any other anti-depressant therapy . HPLC-fluorometric detection assay was used to measure 24-hour urine MHPG sulfate values . The data was analyzed with t-test and Pierson ’s correlation tests . Results : Twenty hour urine MHPG sulfate increased from 1.93 ( ±0.59 ) to 4.66 ( ±0.85 ) micromole in case group ( P ≤ 0.001 ) , and in control group from 1.67 ( ±0.58 ) to 1.80 ( ±0.58 ) micromole . Increase of 24-hour urine MHPG sulfate and increasing of maximum oxygen consumption showed significant positive correlation ( r = 0.65 ) , and a significant negative correlation ( r = 0.65 ) was observed between urine MHPG sulfate and Hamilton Rating Scale for Depression ( Ham-D ) score . Conclusion : Aerobics training in exhilarating environments shows desirable influence over reduction of depression . This reduction of depression is correlated with MHPG sulfate elevation Background Frailty is common in older age , and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care . Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility . Methods / Design The Home-Based Older People 's Exercise ( HOPE ) trial is a two arm , assessor blind pilot r and omised controlled trial ( RCT ) to assess the effectiveness of a 12 week exercise intervention ( the HOPE programme ) design ed to improve the mobility and functional abilities of frail older people living at home , compared with usual care . The primary outcome is the timed-up- and -go test ( TUGT ) , measured at baseline and 14 weeks post-r and omisation . Secondary outcomes include the Barthel Index of activities of daily living ( ADL ) , EuroQol Group 5-Dimension Self-Report Question naire ( EQ-5D ) quality of life measure and the geriatric depression scale ( GDS ) , measured at baseline and 14 weeks post-r and omisation . We will record baseline frailty using the Edmonton Frail Scale ( EFS ) , record falls and document muscle/joint pain . We will test the feasibility of collection of data to identify therapy re sources required for delivery of the intervention . Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people . Although previous RCTs have used operationalised , non-vali date d methods of measuring frailty , the HOPE trial is , to our knowledge , the first RCT of an exercise intervention for frail older people that includes a vali date d method of frailty assessment at baseline . Trial registration IS RCT N : IS RCT Background Interventions are needed which can successfully modify more than one disease risk factor at a time , but much remains to be learned about the acceptability , feasibility , and effectiveness of multiple risk factor ( MRF ) interventions . To address these issues and inform future intervention development , we conducted a r and omized pilot trial ( n = 52 ) . This study was design ed to assess the feasibility and acceptability of the Step Up program , a MRF cognitive-behavioral program design ed to improve participants ' mental and physical well-being by reducing depressive symptoms , promoting smoking cessation , and increasing physical activity . Methods Participants were recruited from a large health care organization and r and omized to receive usual care treatment for depression , smoking , and physical activity promotion or the phone-based Step Up counseling program plus usual care . Participants were assessed at baseline , three and six months . Results The intervention was acceptable to participants and feasible to offer within a healthcare system . The pilot also offered important insights into the optimal design of a MRF program . While not powered to detect clinical ly significant outcomes , changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression . Significantly more experimental participants reported a clinical ly significant improvement ( 50 % reduction ) in their baseline depression score at four months ( 54 % vs. 26 % , OR = 3.35 , 95 % CI [ 1.01- 12.10 ] , p = 0.05 ) and 6 months ( 52 % vs. 13 % , OR = 7.27 , 95 % CI [ 1.85 - 37.30 ] , p = 0.004 ) Conclusions Overall , results suggest the Step Up program warrants additional research , although some program enhancements may be beneficial . Key lessons learned from this research are shared to promote the underst and ing of others working in this field . Trial registration The trial is registered with Clinical Trials.gov ( NCT00644995 ) Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care . Design Pragmatic , multicentre , two arm parallel r and omised controlled trial . Setting General practice s in Bristol and Exeter . Participants 361 adults aged 18 - 69 who had recently consulted their general practitioner with symptoms of depression . All those r and omised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more . Interventions In addition to usual care , intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months . The intervention was based on theory and aim ed to provide individually tailored support and encouragement to engage in physical activity . Main outcome measures The primary outcome was self reported symptoms of depression , assessed with the Beck depression inventory at four months post-r and omisation . Secondary outcomes included use of antidepressants and physical activity at the four , eight , and 12 month follow-up points , and symptoms of depression at eight and 12 month follow-up . Results There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group ; adjusted between group difference in mean Beck depression inventory score −0.54 ( 95 % confidence interval −3.06 to 1.99 ; P=0.68 ) . Similarly , there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points . Nor was there evidence that the intervention reduced antidepressant use compared with usual care ( adjusted odds ratio 0.63 , 95 % confidence interval 0.19 to 2.06 ; P=0.44 ) over the duration of the trial . However , participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group ( adjusted odds ratio 2.27 , 95 % confidence interval 1.32 to 3.89 ; P=0.003 ) . Conclusions The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone . Trial registration Current Controlled Trials IS RCT N16900744 BACKGROUND Sleep disturbances , depression , and low perception of health status are commonly seen in elderly population ; however , clinicians tend to underestimate or overlook the presence of these symptoms and assume them to be a part of normal aging . Non-pharmacological methods that promote a mind-body interaction should be tested to enhance the mental health of older adults . OBJECTIVE To test the effects of 6 months of silver yoga exercises in promoting the mental health of older adults in senior activity centers , especially their sleep quality , depression , and self-perception of health status . DESIGN Cluster r and omized trial . SETTING S Eight senior activity centers , southern Taiwan . PARTICIPANTS A sample of 139 participants was recruited , and 128 of them completed the study . INCLUSION CRITERIA ( 1 ) community-dwelling older adults ages 60 and over , ( 2 ) no previous training in yoga , ( 3 ) able to walk without assistance , ( 4 ) cognitively alert based on the Short Portable Mental Status Question naire ( SPMSQ ) score of eight or higher , and ( 5 ) independent or mildly dependent in self-care based on a Barthel Index ( BI ) score of 91 or higher . The mean age of the participants was 69.20 + /- 6.23 years , and the average number of chronic illness was 0.83 + /- 0.90 . The average BI score of the participants was 99.92 + /- 0.62 , and the mean SPMSQ score was 9.90 + /- 0.30 . METHODS Participants were r and omly assigned into either the experimental ( n=62 ) or the control ( n=66 ) group based on attendance at selected senior activity centers . A 70-min silver yoga exercise program was implemented three times per week for 6 months as the intervention for the participants in the experimental group . RESULTS Most of the mental health indicators of the participants in the experimental group had significantly improved after the silver yoga interventions , and many of the indicators improved after 3 months of intervention and were maintained throughout the 6 months study . The mental health indicators of the participants in the experimental group were all better than the participants in the control group ( all p<.05 ) . CONCLUSIONS After 6 months of silver yoga exercises , the sleep quality , depression , and health status of older adults were all improved Background No controlled trials have evaluated the long term efficacy of exercise activity to improve the treatment of patients with Major Depressive Disorders . The aim of the present study was to confirm the efficacy of the adjunctive physical activity in the treatment of major depressive disorders , with a long term follow up ( 8 months ) . Methods Trial with r and omized naturalistic control . Patients selected from the clinical activity registries of the Psychiatric Unit of the University of Cagliari , Italy . Inclusion criteria : female , between 40 and 60 years , diagnosis of Major Depressive Disorders ( DSM-IV TR ) resistant to the ongoing treatment . Exclusion criteria : diagnosis of psychotic disorders ; any contraindications to physical activity.30 patients ( 71.4 % of the eligible ) participated to the study .Cases : 10 r and omized patients undergoing pharmacological treatment plus physical activity . Controls : 20 patients undergoing only pharmacological therapy . The following tools were collected from each patient by two different psychiatric physicians at baseline and 8 month after the beginning of exercise program : SCID-I , HAM-D , CGI ( Clinical Global Impression ) , GAF . Results The patients that made physical activity had their HAM-D , GAF and CGI score improved from T0 to T8 , all differences were statistically significant . In the control group HAM-D , GAF and CGI scores do not show any statistically significant differences between T0 and T8.LimitsSmall sample size limited to female in adult age ; control group was not subject to any structured rehabilitation activity or placebo so it was impossible to evaluate if the improvement was due to a non specific therapeutic effect associated with taking part in a social activity . Conclusion Physical activity seems a good adjunctive treatment in the long term management of patients with MDD . R and omized placebo controlled trials are needed to confirm the results BACKGROUND Aerobic endurance exercise has been shown to improve higher cognitive functions such as executive control in healthy subjects . We tested the hypothesis that a 30-minute individually customized endurance exercise program has the potential to enhance executive functions in patients with major depressive disorder . METHOD In a r and omized within-subject study design , 24 patients with DSM-IV major depressive disorder and 10 healthy control subjects performed 30 minutes of aerobic endurance exercise at 2 different workload levels of 40 % and 60 % of their predetermined individual 4-mmol/L lactic acid exercise capacity . They were then tested with 4 st and ardized computerized neuropsychological paradigms measuring executive control functions : the task switch paradigm , flanker task , Stroop task , and GoNogo task . Performance was measured by reaction time . Data were gathered between fall 2000 and spring 2002 . RESULTS While there were no significant exercise-dependent alterations in reaction time in the control group , for depressive patients we observed a significant decrease in mean reaction time for the congruent Stroop task condition at the 60 % energy level ( p = .016 ) , for the incongruent Stroop task condition at the 40 % energy level ( p = .02 ) , and for the GoNogo task at both energy levels ( 40 % , p = .025 ; 60 % , p = .048 ) . The exercise procedures had no significant effect on reaction time in the task switch paradigm or the flanker task . CONCLUSION A single 30-minute aerobic endurance exercise program performed by depressed patients has positive effects on executive control processes that appear to be specifically subserved by the anterior cingulate OBJECTIVES To compare the effects of three fall-prevention programs ( education ( ED ) , home safety assessment and modification ( HSAM ) , and exercise training ( ET ) ) on quality of life ( QOL ) , functional balance and gait , activities of daily living ( ADLs ) , fear of falling , and depression in adults aged 65 and older . DESIGN A 4-month r and omized trial . SETTING R and omized , controlled trial . PARTICIPANTS One hundred fifty participants who had experienced a recent fall . MEASUREMENTS QOL was assessed according to the brief version of the World Health Organization Quality of Life instrument ( WHOQOL-BREF ) , functional balance and gait according to functional reach and Tinetti balance and gait , ADLs according to the Older Americans Re sources and Services question naire , fear of falling according to a visual analog scale , and depression level according to the Geriatric Depression Scale . RESULTS The score changes for the ET group were 2.1 points greater on the physical domain ( 95 % confidence interval (CI)=-1.2 - 5.3 ) , 3.8 points greater on the psychological domain ( 95 % CI=0.7 - 7.0 ) , and for the WHOQOL-BREF , 3.4 points greater on the social domain ( 95 % CI=0.7 - 6.1 ) and 3.2 points greater on the environmental domain ( 95 % CI=0.6 - 5.7 ) than for the ED group . The score change for each domain of the WHOQOL-BREF for the HSAM group was greater than that for the ED group , although these results were not statistically significant . The ET group also had greater improvements in functional reach , Tinetti balance and gait , and fear of falling than the ED group . CONCLUSION The QOL outcome supports the superiority of ET over the other two interventions in older people who have recently fallen . This finding also parallels those gathered from the functional measures Background Coronary heart disease ( CHD ) and depression are leading causes of disease burden globally and the two often co-exist . Depression is common after Myocardial Infa rct ion ( MI ) and it has been estimated that 15 - 35 % of patients experience depressive symptoms . Co-morbid depression can impair health related quality of life ( HRQOL ) , decrease medication adherence and appropriate utilisation of health services , lead to increased morbidity and suicide risk , and is associated with poorer CHD risk factor profiles and reduced survival . We aim to determine the feasibility of conducting a r and omised , multi-centre trial design ed to compare a tele-health program ( MoodCare ) for depression and CHD secondary prevention , with Usual Care ( UC ) . Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome ( ACS ) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensl and . Consenting participants are then contacted at two weeks post-discharge for baseline assessment . One hundred eligible participants are to be r and omised to an intervention or a usual medical care control group ( 50 per group ) . The intervention consists of up to 10 × 30 - 40 minute structured telephone sessions , delivered by registered psychologists , commencing within two weeks of baseline screening . The intervention focuses on depression management , lifestyle factors ( physical activity , healthy eating , smoking cessation , alcohol intake ) , medication adherence and managing co-morbidities . Data collection occurs at baseline ( Time 1 ) , 6 months ( post-intervention ) ( Time 2 ) , 12 months ( Time 3 ) and 24 months follow-up for longer term effects ( Time 4 ) . We are comparing depression ( Cardiac Depression Scale [ CDS ] ) and HRQOL ( Short Form-12 [ SF-12 ] ) scores between treatment and UC groups , assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects . A cost-effectiveness analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government . Discussion This manuscript presents the protocol for a r and omised , multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients . The results of this trial will provide valuable new information about potential psychological and wellbeing benefits , cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression . Trial Registration NumberAustralia and New Zeal and Clinical Trials Register ( ANZCTR ) : Objective : Many middle-aged women experience decreases in their sleep quality during the menopausal transition . Physical activity has been shown to improve sleep , but few r and omized , controlled trials investigating such effects in this population exist . In 164 previously low-active middle-aged women ( mean age = 49.9 , SD = 3.6 ) , using a 4-month r and omized , controlled trial , we examined structured exercise in the form of walking or yoga to determine the effects on perceived sleep quality . Design : Participants completed body composition and fitness assessment s and a battery of psychological measures , including the Pittsburgh Sleep Quality Index , at the beginning and end of a 4-month r and omized , controlled exercise trial with three arms : walking , yoga , and control . Results : A series of mixed-model repeated- measures univariate analyses of covariance did not reveal any statistically significant intervention effects for total sleep quality or any individual sleep- quality domain . The pattern of effect sizes indicated that the walking group tended to experience small improvements in five of the seven assessed sleep- quality domains . Residual changes in menopausal symptoms and depression were associated with residual changes in total sleep quality . However , after controlling for the effects of physical activity , only menopausal symptoms contributed a unique amount of variance in residual change in total sleep quality . Conclusions : In this study , 4-month moderate-intensity walking and low-intensity yoga programs were ineffective in yielding statistically significant improvements in sleep quality . Exercise interventions of longer duration s or greater intensity may be needed for such improvements Type D personality has been shown to increase the risk for cardiovascular events in patients with coronary artery disease ( CAD ) . We investigated the effects of exp and ed cardiac rehabilitation on type D score and psychosocial characteristics in 224 CAD patients r and omised to either exp and ed cardiac rehabilitation ( stress management , increased physical training , stay at a “ Patient Hotel ” after discharge and cooking sessions ) , or routine rehabilitation . Follow-up was 1 year . At baseline patients with a high type D score [ patients in the upper quartile of type D score ( Q4 ) i.e. , type D patients ] had a lower sense of coherence ( p < 0.001 ) , a lower quality of life ( p < 0.001 ) , more depressive symptoms ( p < 0.001 ) and increased anxiety ( p < 0.001 ) as compared to patients with a low type D score ( Q1 ) . During follow-up , type D patients ( Q4 ) r and omised to intervention had significant decrements in type D-score ( p < 0.01 ) , depression and anxiety ( p < 0.05 ) and an increment in quality of life scores ( p < 0.001 ) . Quality of life was also improved in control type D patients ( Q4 ; p < 0.01 ) but no significant changes were seen in type D score , depression or anxiety . Exp and ed cardiac rehabilitation reduces type D score , anxiety and depressive symptoms , and improves the quality of life in type D patients This study examined the effects of a 12-week aerobic exercise program on psychological well-being and cognitive functioning in a group of ethnically diverse older adults living in an urban community . Forty-eight older men and women ( mean age = 72 + /- 6 ) were r and omly assigned to one of three groups : an aerobic exercise training group , a social activity control group , or a waiting list group . Results indicated little change in psychological well-being and provided limited support for the association of physiological improvement with enhanced mastery and cognitive functioning Effects of consistent aerobic exercise on depression , anxiety , and health locus of control for a group of non clinical inactive women were investigated . Type A and Type H ( hard-driving ) behavioral styles were evaluated to determine whether these traits were related to exercise improvement . 26 women were r and omly assigned to either an exercise group ( n = 10 ) or exercise with cognitive strategy instructions ( n = 16 ) . All subjects increased distance run in 12-min . run test from pre-to posttest . Women improved in depression and trait anxiety . Depression was significantly correlated with body mass index at end of program . Posttest state-anxiety was significantly correlated with 6-wk . follow-up of exercise frequency . No significant difference in pre- and posttest health locus of control was found . Type H scores were significantly correlated with number of exercise sessions attended . Consistent aerobic exercise had a positive effect on psychological functioning , and some characteristics may affect exercise improvement Objectives : To explore autogenic training ( AT ) as a treatment for psychological morbidity , symptomology , and physiological markers of stress among women with chest pain , a positive exercise test for myocardial ischemia , and normal coronary arteries ( cardiac syndrome X ) . Design : Fifty-three women with cardiac syndrome X ( mean ± SD age , 57.1 ± 8 years ) were r and omized to an 8-week AT program or symptom diary control . Symptom severity and frequency , Hospital Anxiety and Depression Scale , Spielberger State-Trait Anxiety Inventory , Cardiac Anxiety Question naire ( CAQ ) , and Ferrans and Powers Quality of Life Index ( QLI ) , blood pressure , heart rate , electrocardiogram , and plasma catecholamines were measured before and after intervention and at the 8-week follow-up . Results : Women who underwent AT had improved symptom frequency ( 8.04 ± 10.08 vs 1.66 ± 2.19 , P < 0.001 ) compared with control women and reduced symtom severity ( 2.08 ± 1.03 vs 1.23 ± 1.36 , P = 0.02 ) and frequency ( 6.11 ± 3.17 vs 1.66 ± 2.19 , P < 0.001 ) post-AT compared with baseline within group . Within-group improvements among women who underwent AT include QLI health functioning ( 17.80 ± 5.74 vs 19.41 ± 5.19 , P = 0.04 ) and CAQ fear ( 1.53 ± 0.61 vs 1.35 ± 0.56 , P = 0.02 ) post-AT and QLI health functioning ( 17.80 ± 5.74 vs 20.09 ± 5.47 , P = 0.01 ) , CAQ fear ( 1.53 ± 0.61 vs 1.30 ± 0.67 , P = 0.002 ) , CAQ total ( 1.42 ± 0.54 vs 1.29 ± 0.475 , P = 0.04 ) , Spielberger State-Trait Anxiety Inventory trait anxiety ( 42.95 ± 11.19 vs 38.68 ± 11.47 , P = 0.01 ) , and QLI quality of life ( 20.67 ± 5.37 vs 21.9 ± 4.89 , P = 0.02 ) at follow-up . Conclusion : An 8-week AT program improves symptom frequency , with near-significant improvements in symptom severity in women with cardiac syndrome & NA ; Chronic pain is a common , disabling problem in older adults . Pain self‐management training is a multimodal therapy that has been found to be effective in young to middle‐aged adult sample s ; however , few studies have examined the effectiveness of this therapy in older adults . In this r and omized , controlled trial , we evaluated a pain self‐management training group ( SMG ) intervention as compared with an education‐only ( BOOK ) control condition . Participants , 65 years of age or older who experienced persistent , noncancer pain that limited their activities , were recruited from 43 retirement communities in the Pacific Northwest of the United States . The primary outcome was physical disability , as measured by the Rol and ‐Morris Disability Question naire . Secondary outcomes were depression ( Geriatric Depression Scale ) , pain intensity ( Brief Pain Inventory ) , and pain‐related interference with activities ( Brief Pain Inventory ) . R and omization occurred by facility to minimize cross‐contamination between groups . Two‐hundred and fifty‐six individuals , mean age = 81.8 ( SD : 6.5 ) , enrolled and 218 completed the study . No significant differences in outcomes were found between groups at post‐intervention , 6‐month follow‐up , or 12‐month follow‐up . The SMG group showed a significantly greater increase over time , relative to the BOOK group , in two process measures , as measured by the Chronic Pain Coping Inventory : use of relaxation and use of exercise/stretching . In both cases , the increase was greatest from baseline to the post‐intervention assessment . Study findings indicate that additional research is needed to determine the most effective content and delivery methods for self‐management therapies targeted at older adults with chronic pain BACKGROUND Improved quality of life ( QOL ) is a purported benefit of exercise , but few r and omized controlled trials and no dose-response trials have been conducted to examine this assertion . METHODS The effect of 50 % , 100 % , and 150 % of the physical activity recommendation on QOL was examined in a 6-month r and omized controlled trial . Participants were 430 sedentary postmenopausal women ( body mass index range , 25.0 - 43.0 [ calculated as weight in kilograms divided by height in meters squared ] ) with elevated systolic blood pressure r and omized to a nonexercise control group ( n = 92 ) or 1 of 3 exercise groups : exercise energy expenditure of 4 ( n = 147 ) , 8 ( n = 96 ) , or 12 ( n = 95 ) kilocalories per kilogram of body weight per week . Eight aspects of physical and mental QOL were measured at baseline and month 6 with the use of the Medical Outcomes Study 36-Item Short Form Health Survey . RESULTS Change in all mental and physical aspects of QOL , except bodily pain , was dose dependent ( trend analyses were significant , and exercise dose was a significant predictor of QOL change ; P < .05 ) . Higher doses of exercise were associated with larger improvements in mental and physical aspects of QOL . Controlling for weight change did not attenuate the exercise-QOL association . CONCLUSION Exercise-induced QOL improvements were dose dependent and independent of weight change CONTEXT Stress , both psychological and physiological , has been implicated as having a role in the onset and exacerbations of rheumatoid arthritis ( RA ) . OBJECTIVE This study investigated whether neuroendocrine and physical function in women with RA can be altered through a yoga intervention . DESIGN Exercise intervention . SETTING University research conducted at a medical clinic . PARTICIPANTS Sixteen independently living , postmenopausal women with an RA classification of I , II , or III according to the American College of Rheumatology functional classification system served as either participants or controls . INTERVENTION The study group participated in three 75-minute yoga classes a week over a 10-week period . MAIN OUTCOME MEASURES At baseline and on completion of the 10-week intervention , diurnal cortisol patterns and resting heart rate were measured . Balance was measured using the Berg Balance Test . Participants completed the Health Assessment Question naire ( HIQ ) , a visual analog pain scale , and the Beck Depression Inventory . RESULTS Yoga result ed in a significantly decreased HAQ disability index , decreased perception of pain and depression , and improved balance . Yoga did not result in a significant change in awakening or diurnal cortisol patterns ( P = .12 ) BACKGROUND Psychological interventions targeting maladaptive pain behaviors and depressive symptoms are commonly used in the management of chronic pain . OBJECTIVE To compare the effectiveness of psychotherapy , based on client-centered therapy , and exercise for patients with chronic nonspecific low back pain ( LBP ) . SETTING Outpatient physiotherapy and psychotherapy departments within a Brazilian academic institution . DESIGN Thirty-three patients with chronic nonspecific LBP were recruited and r and omized to receive client-centered therapy ( N = 16 ) or exercise ( N = 17 ) for 9 weeks . OUTCOME MEASURES AND DATA ANALYSIS : Pain and disability were measured at baseline , 9 weeks , and 6 months by a 10-cm visual analog scale and by the Brazilian Rol and -Morris Question naire , respectively . Depression was measured at baseline and 9 weeks by the Beck Depression Inventory . Multiple regression analyses with baseline scores as covariates were used to determine the effects of treatment on outcomes . RESULTS For all outcomes at each time point , the exercise group showed greater improvements than psychotherapy . The difference between groups was statistically and clinical ly significant for disability at 9 weeks ( -4.9 points , 95 % CI -9.08 to -0.72 ) . CONCLUSIONS This was the first study to investigate the effects of client-centered therapy and exercise for patients with chronic LBP . Our results showed that client-centered therapy is less effective than exercise in reducing disability at short term BACKGROUND Although the literature on increased physical fitness and psychological outcomes has grown large , a number of method ological limitations remain unaddressed . The present study was design ed to address a number of these limitations while examining the short- and long-term psychological effects following completion of a 12-week aerobic fitness program using bicycle ergometry ( and confirmed increases in fitness ) . METHOD Following completion of a 12-week aerobic fitness program ( and through 12 months of follow-up ) , 82 adult participants completed the Beck Depression Inventory , Profile of Mood States , State-Trait Anxiety Inventory , and the Tennessee Self-Concept Scale . Physiological measures used to assess changes in aerobic fitness were maximal work load , submaximal heart rate at a st and ard work load , predicted maximum oxygen uptake , and resting heart rate . RESULTS Exercise participants experienced a positive fitness change and psychological improvement over the initial 12-week program compared to a control group . At 1 year follow-up , physiological and psychological benefits remained significantly improved from baseline . CONCLUSIONS Overall , results indicate that exercise-induced increases in aerobic fitness have beneficial short-term and long-term effects on psychological outcomes . We postulate that participants in the exercise group did not increase the amount of weekly exercise they performed over the 12-month follow-up period and thus the maintenance of the psychological improvements occurred concurrent with equal or lesser amounts of exercise To determine the effects of exercise training programs on psychosocial improvement in uncomplicated postmyocardial infa rct ion patients , 210 male patients hospitalized for an acute myocardial infa rct ion ( MI ) were r and omized to three week symptom limited treadmill ( TM ) plus home exercise training , TM plus medically supervised gym training , TM without formal exercise program or control , where patients were seen only at six months post MI . Patients in this sample were at low risk for psychosocial disturbance ( 13 % were moderate to severely depressed , 23 % reported marital disturbance and 3 % were extremely anxious ) . Patients in the training groups improved from 3 to 26 weeks post MI on all depression and anxiety measures . The gym training group showed a significant reduction on one depression measure compared to no training and on one anxiety measure compared to controls This study compares the effects of a structured exercise training program to the therapeutic benefits of a ' support ' group on the depressed mood and reduced performance of pleasant activities by hemodialysis patients . After 6 months of an aerobic exercise training program , the 10 exercisers showed a significant increase in maximal aerobic capacity ( VO2max ) and a significant decrease in dysphoric mood when compared to 7 patients attending the support group . Support group participants reported a significant decrease in pleasant activities while there was no change in the exercisers . Eighteen months after the exercise training program , the exercisers reported continued low levels of depressed mood , and were performing significantly more pleasant activities than they reported prior to the exercise program . The results of this study suggest an exercise training program may be useful in the psychosocial rehabilitation of some hemodialysis patients This study examines and compares the effect of aerobic and resistance exercise on emotional and physical function among older persons with initially high or low depressive symptomatology . Data are from the Fitness , Arthritis and Seniors Trial , a trial among 439 persons 60 years or older with knee osteoarthritis r and omized to health education ( control ) , resistance exercise , or aerobic exercise groups . Depressive symptoms ( assessed by the Center for Epidemiologic Studies --Depression scale ) and physical function ( disability , walking speed , and pain ) were assessed at baseline and after 3 , 9 , and 18 months . Compared with results for the control group , aerobic exercise significantly lowered depressive symptoms over time . No such effect was observed for resistance exercise . The reduction in depressive symptoms with aerobic exercise was found both among the 98 participants with initially high depressive symptomatology and among the 340 participants with initially low depressive symptomatology and was the strongest for the most compliant persons . Aerobic and resistance exercise significantly reduced disability and pain and increased walking speed both , and to an equal extent , in persons with high depressive symptomatology and persons with low depressive symptomatology The purpose of the research project was to examine the effects of exercise , social support and depression on postnatal women who reported experiencing postnatal depression . A 12-week r and omized , controlled trial was conducted investigating the effects of an exercise intervention group ( a pram-walking programme for mothers and their babies ) compared to a social support group ( non-structured sessions , similar to a playgroup ) . Participants in both groups had given birth in the past 12 months . Pretest data of physical fitness and structured question naires were compared to post-test effects . The primary outcomes were to reduce the depressive symptomatology and improve fitness levels of participants in the pram-walking group . Secondary outcomes were to improve the social support levels of the participants in both groups and explore women 's views about the programmes . It was hypothesized that the pram-walking group participants would improve their feelings of depression and fitness levels compared to the social support group , but that both groups would improve their perceived levels of social support . The results showed that mothers in the pram-walking intervention group improved their fitness levels and reduced their level of depressive symptomatology significantly more than the social support group . There were no significant changes to social support levels for both groups . Therefore , a direct association between improvement in fitness was related to improvement in depression for the pram-walking group . However , it is also suggested that other factors in combination with improvements in fitness influenced improvements in depression levels . It is recommended that pram-walking programmes for mothers with postnatal depression be implemented as pilot research into existing available services Levinger , I , Selig , S , Goodman , C , Jerums , G , Stewart , A , and Hare , DL . Resistance training improves depressive symptoms in individuals at high risk for type 2 diabetes . J Strength Cond Res 25(8 ) : 2328 - 2333 , 2011—Depression is more prevalent in obese individuals and those with diabetes , compared to the general population . This study examined the effect of resistance training on depressed mood in individuals with high ( HiMF , n ≥ 2 ) and low ( LoMF , n ≤ 1 ) numbers of risk factors for metabolic syndrome and type 2 diabetes . The primary hypothesis was that resistance training would significantly reduce depressed mood , as measured by the Cardiac Depression Scale ( CDS ) , in individuals with HiMF . Fifty-five middle-aged volunteers ( 50.8 ± 0.9 years , mean ± SEM ) from the general community participated in the study . After initial allocation to HiMF or LoMF , participants were r and omly allocated to 4 groups , HiMF training ( HiMFT ) , HiMF control ( HiMFC ) , LoMF training ( LoMFT ) , and LoMF control ( LoMFC ) . Participants underwent resistance training involving major muscle groups on 3 d·wk−1 for 10 weeks . Before and after interventions ( training or control ) , participants completed the CDS to assess change in the level of depressed mood . Following resistance training , the CDS score of the HiMFT group was reduced by −14.8 ± 4.9 points on the CDS , a significant improvement in comparison to both baseline ( p = 0.01 ) and HiMFC ( p = 0.049 ) values . No significant change was observed for LoMFT . In the HiMF group only , the percent change in relative muscle strength was correlated with the Δ change in CDS ; r = −0.46 , p = 0.008 . Resistance exercise training programs that consist 7 exercises for the major muscle groups at both low-moderate and moderate-high intensities appear to alleviate depressed mood in individuals with clusters of metabolic risk factors INTRODUCTION Depressive symptoms negatively impact smoking abstinence . However , few interventions have been targeted to smokers with current depression . Exercise improves mood and may benefit depressed smokers . This pilot study investigated the feasibility of an exercise intervention for depressed female smokers ( Center for Epidemiological Studies Depression Scale [ CES-D ] score > or = 16 ) . METHODS Participants ( M = 41 years , 98 % White ) were r and omized to 10 weeks of individually delivered exercise counseling ( n = 30 ) or a health education contact control condition ( n = 30 ) . All participants received nicotine patch therapy and behavioral counseling for smoking cessation . RESULTS The intervention was feasible as indicated by ability to recruit participants , exercise counseling session attendance ( M = 7.6 of 10 sessions attended ) , and significant increase in exercise frequency and stage of change from baseline to end of treatment ( EOT ) ( Week 10 ) . Participant attrition rate was 35 % by Week 10 but did not differ significantly between groups . Smoking abstinence rates at Week 10 , using intention-to-treat analysis , were 17 % for exercise counseling participants and 23 % for health education participants ( p = .75 ) . DISCUSSION An exercise counseling intervention was found to be feasible for depressed women smokers . More intensive intervention may be needed to increase smoking abstinence rates , and methods should be refined to reduce participant burden and attrition OBJECTIVE To determine the effects of structured exercise programs on self-reported disability in older adults with knee osteoarthritis . SETTING AND DESIGN A r and omized , single-blind clinical trial lasting 18 months conducted at 2 academic medical centers . PARTICIPANTS A total of 439 community-dwelling adults , aged 60 years or older , with radiographically evident knee osteoarthritis , pain , and self-reported physical disability . INTERVENTIONS An aerobic exercise program , a resistance exercise program , and a health education program . MAIN OUTCOME MEASURES The primary outcome was self-reported disability score ( range , 1 - 5 ) . The secondary outcomes were knee pain score ( range , 1 - 6 ) , performance measures of physical function , x-ray score , aerobic capacity , and knee muscle strength . RESULTS A total of 365 ( 83 % ) participants completed the trial . Overall compliance with the exercise prescription was 68 % in the aerobic training group and 70 % in the resistance training group . Postr and omization , participants in the aerobic exercise group had a 10 % lower adjusted mean ( + /- SE ) score on the physical disability question naire ( 1.71 + /- 0.03 vs 1.90 + /- 0.04 units ; P<.001 ) , a 12 % lower score on the knee pain question naire ( 2.1 + /- 0.05 vs 2.4 + /- 0.05 units ; P=.001 ) , and performed better ( mean [ + /- SE ] ) on the 6-minute walk test ( 1507 + /- 16 vs 1349 + /- 16 ft ; P<.001 ) , mean ( + /-SE ) time to climb and descend stairs ( 12.7 + /- 0.4 vs 13.9 + /- 0.4 seconds ; P=.05 ) , time to lift and carry 10 pounds ( 9.1 + /- 0.2 vs 10.0 + /- 0.1 seconds ; P<.001 ) , and mean ( + /-SE ) time to get in and out of a car ( 8.7 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P<.001 ) than the health education group . The resistance exercise group had an 8 % lower score on the physical disability question naire ( 1.74 + /- 0.04 vs 1.90 + /- 0.03 units ; P=.003 ) , 8 % lower pain score ( 2.2 + /- 0.06 vs 2.4 + /- 0.05 units ; P=.02 ) , greater distance on the 6-minute walk ( 1406 + /- 17 vs 1349 + /- 16 ft ; P=.02 ) , faster times on the lifting and carrying task ( 9.3 + /- 0.1 vs 10.0 + /- 0.16 seconds ; P=.001 ) , and the car task ( 9.0 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P=.003 ) than the health education group . There were no differences in x-ray scores between either exercise group and the health education group . CONCLUSIONS Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability , physical performance , and pain from participating in either an aerobic or a resistance exercise program . These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis OBJECTIVES To evaluate the association between neighborhood walkability and depression in older adults . DESIGN Cross-sectional analysis using data from Adult Changes in Thought ( ACT ) , a prospect i ve , longitudinal cohort study . SETTING King County , Washington . PARTICIPANTS Seven hundred forty r and omly selected men and women aged 65 and older , cognitively intact , living in the same home for at least 2 years . MEASUREMENTS Depressive symptoms were measured with the Center for Epidemiologic Studies Depression Scale . The Walkable and Bikable Communities Project provided objective data predicting the probability of walking at least 150 minutes per week in a particular neighborhood . ACT data were linked at the individual level via a geographic information system to this walkability score using buffer radii of 100 , 500 , and 1,000 meters around the subject 's home . Multiple regression analysis tests were conducted for associations between the buffer-specific neighborhood walkability score and depressive symptoms . RESULTS There was a significant association between neighborhood walkability and depressive symptoms in men when adjusted for individual-level factors of income , physical activity , education , smoking status , living alone , age , ethnicity , and chronic disease . The odds ratio for the interquartile range ( 25th to 75th percentile ) of walkability score was 0.31 to 0.33 for the buffer radii ( P=.02 ) , indicating a protective association with neighborhood walkability . This association was not significant in women . CONCLUSION This study demonstrates a significant association between neighborhood walkability and depressive symptoms in older men . Further research on the effects of neighborhood walkability may inform community-level mental health treatment and focus depression screening in less-walkable areas BACKGROUND Depression in elderly people may be contributed to by the multiple losses of aging . Exercise has the potential to positively impact many of these losses simultaneously . We tested the hypothesis that progressive resistance training ( PRT ) would reduce depression while improving physiologic capacity , quality of life , morale , function and self-efficacy without adverse events in an older , significantly depressed population . METHODS We conducted a 10-week r and omized controlled trial of volunteers aged 60 and above with major or minor depression or dysthymia . Subjects were r and omized for 10 weeks to either a supervised PRT program three times a week or an attention-control group . RESULTS A total of 32 subjects aged 60 - 84 , mean age 71.3 + /- 1.2 yr , were r and omized and completed the study . No significant adverse events occurred . Median compliance was 95 % . PRT significantly reduced all depression measures ( Beck Depression Inventory in exercisers 21.3 + /- 1.8 to 9.8 + /- 2.4 versus controls 18.4 + /- 1.7 to 13.8 + /- 2 , p = .002 ; Hamilton Rating Scale of Depression in exercisers 12.3 + /- 0.9 to 5.3 + /- 1.3 versus controls 11.4 + /- 1.0 to 8.9 + /- 1.3 , p = .008 ) . Quality of life subscales of bodily pain ( p = .001 ) , vitality ( p = .002 ) , social functioning ( p = .008 ) , and role emotional ( p = .02 ) were all significantly improved by exercise compared to controls . Strength increased a mean of 33 % + /- 4 % in exercisers and decreased 2 % + /- 2 % in controls ( p < .0001 ) . In a multiple stepwise regression model , intensity of training was a significant independent predictor of decrease in depression scores ( r2 = .617 , p = .0002 ) . CONCLUSIONS PRT is an effective antidepressant in depressed elders , while also improving strength , morale , and quality of life OBJECTIVE To investigate the effect of a moderate to high intensive exercise program on two primary outcomes ( aerobic capacity , fatigue ) , and three secondary outcomes [ anxiety , depression and health-related quality of life ( HRQoL ) ] in women with primary Sjögren 's syndrome ( primary SS ) . METHODS Twenty-one women with primary SS were ranked according to degree of fatigue and allocated to an exercise group ( TG ; n = 11 ) or a control group ( CG ; n = 10 ) . The exercise method was Nordic walking for 45 min three times a week for 12 weeks . Outcome measures assessed at baseline and after 12 weeks were aerobic capacity , fatigue , ratings of perceived exertion ( RPE ) , anxiety , depression and HRQoL. RESULTS Nine women in the TG and 10 women in the CG completed the study . Analysis showed significant differences between the groups regarding aerobic capacity ( P = 0.03 ) , fatigue ( P = 0.03 ) , RPE ( P = 0.03 ) , and depression ( P = 0.02 ) with the better values for the TG . There were no differences in anxiety or HRQoL. CONCLUSION Our findings support the use of appropriate aerobic exercise in the treatment of primary SS BACKGROUND There is increasing interest in the health-promoting potential of physical activity in older adults . The objective of this study was to estimate the likely costs , health benefits and consequences for the National Health Service which might result from a publicly funded programme of regular exercise made available to a population of 10,000 people over the age of 65 . METHODS Risk education data from observational studies were used to calculate the possible impact of a community-based programme of activity on hospital admissions and deaths from coronary heart disease , stroke , diabetes , femoral neck fractures and mental disorders . The avoided costs of health care and net cost per life-year saved were estimated . RESULTS Providing twice-weekly exercise classes for 10,000 participants would cost approximately 854,700 pounds per year , but would prevent 76 deaths and 230 in-patient episodes , avoiding annual health care costs of approximately 601,000 pounds . Assuming the mean expectation of life after 65 to be ten years , the programme would cost about 330 pounds per life-year saved . Under a range of more extreme assumptions , the cost per life-year saved would vary from 100 pounds to 1500 pounds . CONCLUSIONS A publicly funded programme of regular moderate exercise for over-65-year-olds could achieve important health benefits at relatively low cost . The estimates provided by this analysis should now be tested in a rigorous r and omized trial , and health commissioners should begin to think of purchasing exercise programmes alongside other health-promoting measures Background Depression is relatively common in patients with coronary heart disease ( CHD ) and is associated with worse prognosis . Recently there has been interest in evaluating the impact of treating depression on clinical outcomes . Anti-depressant medications have been shown to be safe and efficacious for many patients ; exercise also may be effective for treating depression and may also improve cardiopulmonary functioning . However , method ological limitations of previous studies have raised questions about the value of exercise , and no study has compared the effects of exercise with st and ard anti-depressant medication in depressed cardiac patients . Purpose UPBEAT is a r and omized clinical trial ( RCT ) funded by NHLBI to evaluate the effects of sertraline or exercise compared to placebo on depression and biomarkers of cardiovascular risk in patients with CHD and elevated depressive symptoms . Methods The UPBEAT study includes 200 stable CHD patients with scores on the Beck Depression Inventory ( BDI ) ≥9 r and omized to 4 months of treatment with aerobic exercise , sertraline , or placebo . The primary outcomes include depressive symptoms determined by clinical ratings on the Hamilton Rating Scale for Depression ( HAM-D ) and measures of heart rate variability ( HRV ) , baroreflex control ( BRC ) , vascular function ( i.e. , flow-mediated dilation ( FMD ) ) , and measures of inflammation and platelet aggregation . Results This article review s the rationale and design of UPBEAT and addresses several key method ologic issues that were carefully considered in the development of this protocol : the use of a placebo control condition in depressed cardiac patients , study design , and selection of intermediate endpoints or biomarkers of cardiovascular risk . Limitations This study is not powered to assess treatment group differences in CHD morbidity and mortality . Intermediate endpoints are not equivalent to ` hard ' clinical events and further studies are needed to determine the clinical significance of these biomarkers . Conclusions The UPBEAT study is design ed to assess the efficacy of exercise in treating depression in cardiac patients and evaluates the impact of treating depression on important biomarkers of cardiovascular risk . Clinical Trials 2007 ; 4 : 548—559 . BACKGROUND Despite various studies , supportive evidence for the efficacy of exercise in treatment of mental illness is still weak . OBJECTIVE The aim of this study was to compare two forms of exercise , namely running therapy ( RT ) and physiotraining therapy ( PT ) , on stationary devices . METHODS Patients in a day treatment programme for treatment of affective disorders were r and omly allocated to one of the exercise groups or to a control group . Depression scores , self-efficacy , physical conditions and appreciations of the training programme were measured . RESULTS After 6 weeks , no significant differences were found between both the training groups and the control group ; however , after 12 weeks , the physiotraining group showed significant improvement on scores for blind-rated Hamilton Rating Scale for Depression and on scores for self-rated Beck Depression Inventory 21-item version . CONCLUSIONS Our results suggest that PT has advantages over RT . We speculate that an improved feeling of self-efficacy may be a mediating factor Objective : To evaluate the short-term effects of exercise in patients with major depression . Design : Prospect i ve , r and omised , controlled study . Setting : A university hospital . Patients : A consecutive series of 38 in patients with a major depression episode undergoing st and ard clinical antidepressant drug treatment . Interventions : Patients were r and omly assigned to an exercise ( walking , n = 20 ) or placebo ( low-intensity stretching and relaxation exercises , n = 18 ) group . Training was carried out for 10 days . Main outcome measurements : Severity of depression assessed with the Bech-Rafaelsen Melancholy Scale ( BRMS ) and the Center for Epidemiologic Studies Depression scale ( CES-D ) . Results : After 10 days , reduction of depression scores in the exercise group was significantly larger than in the placebo group ( BRMS : 36 % v 18 % ; CES-D : 41 % v 21 % ; p for both = 0.01 ) ; the proportion of patients with a clinical response ( reduction in the BRMS scores by more than six points ) was also larger for the exercise group ( 65 % v 22 % , p<0.01 ) . Conclusions : Endurance exercise may help to achieve substantial improvement in the mood of selected patients with major depression in a short time Objective : To explore the secondary benefits of treadmill training for people in the chronic stage of recovery from stroke . Design : Modified r and om assignment , matched-pair control group design with repeated measures . Setting : Outpatient stroke centre . Participants : Twenty individuals post first stroke who acknowledged walking slower than pre stroke . Participants matched by side of hemiparesis and motor impairment . Interventions : Twelve 20-minute sessions of walking on a treadmill or weekly phone call . Main outcome measures : Depression ( Beck Depression Index ) , mobility and social participation ( Stroke Impact Scale 3.0 subscales ) were assessed initially , at the end of 12 treatments ( four weeks ) and six weeks later . Results : No significant difference was found between groups for any dependent measure . The ANOVA to investigate main effects in each group found no significant findings in the control group ; however in the treatment group significant improvements over time for depression ( P=0.005 , P<0.001 ) , mobility ( P=0.008 ) and social participation ( P= 0.004 ) were demonstrated . Conclusions : A task-specific intervention design ed to improve gait speed may potentially provide secondary benefits by positively impacting depression , mobility and social participation for people post stroke BACKGROUND Depression is common in later life . AIMS To determine whether exercise is effective as an adjunct to antidepressant therapy in reducing depressive symptoms in older people . METHOD Patients were r and omised to attend either exercise classes or health education talks for 10 weeks . Assessment s were made " blind " at baseline , and at 10 and 34 weeks . The primary outcome was seen with the 17-item Hamilton Rating Scale for Depression ( HRSD ) . Secondary outcomes were seen with the Geriatric Depression Scale , Clinical Global Impression and Patient Global Impression . RESULTS At 10 weeks a significantly higher proportion of the exercise group ( 55 % v. 33 % ) experienced a greater than 30 % decline in depression according to HRSD ( OR=2.51 , P=0.05 , 95 % CI 1.00 - 6.38 ) . CONCLUSIONS Because exercise was associated with a modest improvement in depressive symptoms at 10 weeks , older people with poorly responsive depressive disorder should be encouraged to attend group exercise activities Objectives The purpose of the study was to examine the effects of aerobic exercise on physiological fatigue ( time on treadmill ) , dyspnea [ rate of perceived exertion ( RPE ) and forced expiratory volume at 1 s ( FEV1 ) ] , weight , and body composition in HIV-1-infected adults ( 200–499 × 106 CD4 + cells/l ) . Design The study was a r and omized , wait-listed , controlled clinical trial of aerobic exercise in HIV-1-infected adults on signs and symptoms associated with HIV-1 infection or its treatment . Methods Sixty subjects were recruited and r and omized to two groups . Experimental subjects completed a 12-week supervised exercise program . Control subjects continued usual activity from baseline to week 12 and were then were enrolled in the exercise program . Results At baseline , the groups were similar in age , weight , body mass index [ mean body mass index ( BMI ) > 27 ] , time since diagnosis , number of symptoms , CD4 + cell count , and number on protease inhibitor therapy ( n = 7 ) . Despite disproportionate attrition from the exercise group ( 38 % ) , exercise subjects were able to remain on the treadmill longer , lost weight , decreased BMI , subcutaneous fat , and abdominal girth when compared to controls . The improvement in weight and body composition occurred without a decrease in kilocalories consumed . Exercise did not seem to have an effect on RPE , a surrogate for dyspnea , and FEV1 . There was no significant difference in either the change in CD4 + cell count , percentage or copies of plasma HIV-1 RNA between groups . Conclusions We conclude that supervised aerobic exercise training safely decreases fatigue , weight , BMI , subcutaneous fat and abdominal girth ( central fat ) in HIV-1-infected individuals . It did not appear to have an effect on dyspnea Abstract Background . The diagnosis and treatment of cancer may cause clinical ly significant and persistent psychological morbidity . The objective of this study was to determine the short-term effect of a six week exercise intervention on anxiety and depression in cancer patients undergoing chemotherapy ( The ‘ Body & Cancer ’ trial ) . Methods . Two hundred and nine self-referred patients ( 52 males , 157 females , mean age 47 years ) were r and omised into an intervention group and a waiting-list control group . Anxiety and depression was measured by the Hospital Anxiety and Depression Scale . Results . At baseline , 23.5 % and 11.5 % of the population scored > 8 on the HADS and were classified as suspicious or definite cases of anxiety and depression , respectively . Adjusted for baseline score , disease and demographic covariates the estimated intervention effect showed improvement at six weeks for depression of −0.7 points ( 95 % confidence interval [ CI ] −1.27 to −0.14 , p = 0.0153 ) . No significant effect was seen on anxiety . Further sub analysis , including only suspicious or definite cases of depression , result ed in an estimated intervention effect of −2.53 points ( 95 % CI , −0.64 to −0.42 , p = 0.021 ) . Conclusion . Anti-depressant effects could be caused by exercise in self-referred cancer patients undergoing chemotherapy . Dedicated trials and follow-up studies are needed to clarify the optimal duration and content of exercise interventions to meet the needs of clinical ly depressive or anxious patients AIM AND OBJECTIVE To evaluate the influence of an exercise programme on postmenopausal women with symptoms of anxiety and depression . BACKGROUND The menopause is a period of hormonal changes when mood variations are probably more severe than at any other period of women 's lives . DESIGN Prospect i ve study with control group and pre- and post-treatment measures , after six months treatment . Conducted at two healthcare clinics , in the province of Granada ( Spain ) . METHODS A convenience sample of 60 postmenopausal women aged 60 - 70 years , with symptoms of depression and anxiety , was recruited . The women were r and omly divided into two groups : ( 1 ) control group , no treatment ( n = 30 ) ; ( 2 ) exercise group , which carried out a programme of mixed physical exercises with musical support ( n = 30 ) . All subjects answered question naires for the Hamilton Anxiety Scale and the Brink and Yesavage Geriatric Depression Scale before and after treatment . RESULTS In the exercise group , statistically significant improvements were observed in subjects with moderate and severe depression ( 18 and 22 % , respectively ) and in those with symptoms of anxiety . No such changes were observed in the control group . CONCLUSIONS A controlled programme of physical exercise for postmenopausal women alleviates symptoms of anxiety and depression , and its inclusion in primary healthcare programmes should be considered . RELEVANCE TO CLINICAL PRACTICE Menopausal women may benefit from physical exercise , which attenuates the effects of the physiological and psychological changes associated with the menopause and prevents pathologic changes OBJECTIVES To examine the effect of exercise on depressive symptoms and the effect of baseline depressive symptoms on the benefits from exercise in stroke survivors who have completed acute rehabilitation . DESIGN Planned secondary analysis of the data from a 9-month r and omized , controlled trial . SETTING Participant homes . PARTICIPANTS One hundred stroke survivors who had completed acute rehabilitation . INTERVENTION A progressive , structured , 3-month physical exercise program . MEASUREMENTS Demographics , stroke characteristics , impairments , functional limitations , the Geriatric Depression Scale , the Stroke Impact Scale , and the Medical Outcomes Study 36-Item Short Form . RESULTS Baseline rates of depressive symptoms and other stroke sequelae were similar between the two arms . Ninety-three participants were assessed immediately after the intervention ( 3 months after enrollment ) , and 80 were assessed 9 months after enrollment . Six ( 14 % ) of the exercise group and 16 ( 35.6 % ) of the usual-care group had depressive symptoms at 3 months ( P = .03 ) . At 9 months , three ( 7.5 % ) of the exercisers had significant depressive symptoms compared with 10 ( 25 % ) who received usual care ( P = .07 ) . Participants with and without baseline depressive symptoms had equivalent treatment-related gains in impairments and functional limitations , but only participants with depressive symptoms had improved quality of life . CONCLUSION Exercise may help reduce poststroke depressive symptoms . Depressive symptoms do not limit gains in physical function due to exercise . Exercise may contribute to improved quality of life in those with poststroke depressive symptoms The Depression Outcomes Study of Exercise ( DOSE ) was a r and omized clinical trial to determine whether exercise is an efficacious treatment for mild to moderate major depressive disorder ( MDD ) in adults ages 20 to 45 years . The specific hypotheses under investigation were ( 1 ) active exercise is an efficacious monotherapy for mild to moderate levels of MDD , and ( 2 ) there is a dose-response relation between the exercise amount and reduction in depressive symptoms . The primary outcome measure was the Hamilton Rating Scale for Depression ( HRSD ) collected weekly over 12 weeks . Secondary outcome measures were the Inventory of Depressive Symptoms ( clinician and self-report ) , HRSD scores at 24 weeks , cardiorespiratory fitness , self-efficacy , and quality of life . Eighty men and women who were diagnosed with a Structured Clinical Interview for Depression and who had mild ( HRSD 12 - 16 ) to moderate ( HRSD 17 - 25 ) MDD were r and omized to one of five doses of exercise : 7.0 kcal/kg/week in 3 days/week ; 7.0 kcal/kg/week in 5 days/week ; 17.5 kcal/kg/week in 3 days/week ; 17.5 kcal/kg/week in 5 days/week ; or 3 days/week of stretching and flexibility exercises for 15 to 20 min/session . Participants exercised under supervision in our laboratory over the course of 12 weeks . Symptoms of depression were measured weekly by trained clinical raters blinded to the participant 's treatment assignment . The design of the study restricted participant characteristics to mild to moderate MDD and controlled exercise features to permit the evaluation of exercise as a sole treatment for depression . This study is the first to examine dose-response effects of exercise in participants diagnosed with MDD Background : Psychosocial interventions can improve psychological quality of life ( symptoms of depression and anxiety ) of both women with breast cancer and their partners , but are not offered routinely to women and their partners . Objective : To test the hypotheses that telephone-delivered psychosocial interventions decrease depression and anxiety in women with breast cancer and their partners . Methods : The design of the study was a three-wave repeated measures with a between-subjects factor ( treatment group ) . Ninety-six women and their 96 partners were assigned r and omly to participate in one of three different 6-week programs : ( a ) telephone interpersonal counseling ( TIP-C ) ; ( b ) self-managed exercise ; or ( c ) attention control ( AC ) . Results : The mixed-model analysis of variance for symptoms of depression among women with breast cancer revealed women 's depressive symptom scores decreased over time in all groups . For anxiety , women 's symptoms of anxiety decreased in the TIP-C and exercise groups over time , but not in the AC group . A parallel set of analyses was conducted on partners ' depression and anxiety data . Symptoms of depression and anxiety among the partners decreased substantially over the course of the investigation . Similar to the women , partners ' symptoms of anxiety decreased significantly in the TIP-C and exercise groups , but not in the AC group . Discussion : Findings from this study support that these telephone-delivered psychosocial interventions were effective for decreasing symptoms of depression and anxiety to improve psychological quality of life when compared to an AC group INTRODUCTION / PURPOSE Negative mood symptoms occur frequently in sedentary population s , but individual vulnerability factors for developing these complaints have not been systematic ally evaluated . This investigation examined whether the autonomic nervous system ( ANS ) serves a role in the development of negative mood after controlled exercise withdrawal . METHODS Forty participants ( mean age of 31.3 + /- 7.5 yr , 55 % women ) who exercised regularly ( > or= 30 min of continuous aerobic exercise at least three times a week during the past 6 months ) were r and omized either to withdrawal from regular aerobic exercise ( N=20 ) or to continue regular aerobic exercise ( N=20 ) for 2 wk . Measurements were taken before exercise withdrawal and at 2-wk follow-up . Various dimensions of negative mood were measured with the multidimensional fatigue inventory , profile of mood states , and Beck depression inventory-II . ANS activity was assessed by heart rate variability ( HRV ) analyses , examining low-frequency ( 0.04 - 0.15 Hz : lf ) and high-frequency ( hf ) domains ( 0.15 - 0.40 Hz ) . The lf/hf ratio was used as index of sympathovagal balance . Protocol adherence was documented by ambulatory activity monitoring . RESULTS Exercise withdrawal result ed in significantly higher negative mood scores at follow-up compared with control ( P<0.05 ) . Baseline lf/hf ratios correlated with the increases in symptoms ( r>0.4 ; P<0.05 ) in the exercise-withdrawal group independently of gender , age , weight , baseline fitness level , and baseline symptom status . The exercise-withdrawal and control groups displayed no significant change in hf HRV , lf HRV , or lf/hf HRV during the 2 wk . CONCLUSION Reduced parasympathetic ANS activity as measured by HRV is predictive of the development of negative mood after deprivation of usual exercise activities . No significant changes in HRV were observed during the 2-wk exercise deprivation period . These findings are relevant to the underst and ing of mood changes in response to short-term exercise withdrawal , such as sports injuries and recovery from medical procedures Objective : To investigate the feasibility , acceptability and potential efficacy of group exercise for residents in care homes . Design : Exploratory cluster r and omized controlled trial . Setting : Five r and omly selected care homes in South Birmingham , UK . Participants : Fifty-six care home residents ( mean age 84.5 , 71 % female ) , 39 ( 70 % ) with cognitive impairments . Intervention : Two homes ( n = 28 ) were r and omized to group exercise held twice weekly for five weeks . The remaining three homes ( n = 28 ) formed the control group and received usual care , with no person specifically responsible for exercise training . Outcome measures : Assessment s were conducted at zero ( pre-intervention ) , three ( post-intervention ) and six months ( follow-up ) using the Rivermead Mobility Index and Hospital Anxiety and Depression Scale or Stroke Aphasic Depression Question naire ( depending on cognitive impairment ) . Adherence to group exercise and retention to the study were also documented . Results : No statistically significant improvements in mobility or depression were found in favour of group exercise . Retention to the study was high with 46 ( 82 % ) participants completing all assessment s. Adherence to group exercise was somewhat lower with participants attending a mean of 3.61 out of 8.5 prescribed sessions ( 42.5 % ) . Conclusions : Group exercise can be delivered to care home residents with reduced mobility but it is not suitable for residents with severe cognitive impairment . An estimated sample size of 240 participants would be required to detect a clinical ly significant difference in the Rivermead Mobility Index with 90 % power OBJECTIVE The study aim ed at investigating the quality of life ( QoL ) and physical performance and activity , and their interrelations , in Finnish female breast cancer patients shortly after adjuvant treatments . METHODS A total of 537 disease-free breast cancer survivors aged 35 - 68 years were surveyed at the beginning of a one year r and omized exercise intervention . The patients were interviewed using EORTC QLQ-C30 , FACIT-F , RBDI , and WHQ ( for vasomotor symptoms ) question naires . Physical performance was tested by a 2 km walking test . Physical activity was measured by a question naire and a prospect i ve two-week diary . Multivariate analysis was used to study the factors associated with QoL. RESULTS About 26 % of the patients were rated as depressed , 20.4 % as fatigued , and 82 % suffered from menopausal symptoms . The global QoL was lower than in general population ( 69.4 vs 74.7 , p<0.001 ) . About 62 % of the walking test results were below the population average . Fatigue ( p<0.001 ) , depression ( p<0.001 ) , body mass index ( p = 0.016 ) and comorbidity ( p = 0.032 ) impaired , and physical activity ( p = 0.003 ) improved QoL. Physical activity level correlated positively to physical performance ( r = -0.274 , p<0.0001 ) . CONCLUSIONS The QoL of the patients shortly after adjuvant treatments was impaired and the physical performance poor as compared to general population . In particular , depression and fatigue were related to impaired QoL. Physical performance and activity level were the only factors that correlated positively to QoL. Thus , physical exercise could be useful in rehabilitation of cancer survivors , especially for depressed and fatigued patients We tested the effect of beginning an exercise program on the mood of sedentary men who were free of psychopathology . Fourteen men were r and omly assigned to either an exercise program or a control period for 12 weeks and then switched to the converse condition . The exercise was nonsocial and of moderate intensity . Exercise did not improve anger , tension , confusion , depression , fatigue , vigor , or total mood disturbance more than a control period . We conclude that beginning an exercise program , in itself , produces minimal psychological benefits . We hypothesize that other conditions , e.g. the presence of emotional problems , socialization along with exercise , or a training effect must be present for exercise to produce psychological benefits The purpose of this study was to conduct a pilot clinical trial to test the feasibility and efficacy of an exercise program and anti-depressant treatment compared with usual care in improving the emotional and physical functioning of older adults with minor depression . Participants were 37 older adults with minor depression who were r and omized to exercise , sertraline , or usual care ; 32 participants completed the 16-week study . Outcomes included measures of both emotional ( clinician and self-report ) and physical ( observed and self-report ) functioning . There were trends for the superiority of the exercise and sertraline conditions over usual care in improving SF-36 mental health scores and clinician-rated depression scores . Individuals in the exercise condition showed greater improvements in physical functioning than individuals in the usual care condition . Both sertraline and exercise show promise as treatments for late-life minor depression . However , exercise has the added benefit of improving physical functioning as well OBJECTIVE To assess the benefit and harm of exercise training in adults with clinical depression . METHOD The DEMO trial is a r and omized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007 . Patients were referred from general practitioners or psychiatrists and were eligible if they fulfilled the International Classification of Diseases , Tenth Revision , criteria for unipolar depression and were aged between 18 and 55 years . Patients ( N = 165 ) were allocated to supervised strength , aerobic , or relaxation training during a 4-month period . The primary outcome measure was the 17-item Hamilton Rating Scale for Depression ( HAM-D(17 ) ) , the secondary outcome measure was the percentage of days absent from work during the last 10 working days , and the tertiary outcome measure was effect on cognitive abilities . RESULTS At 4 months , the strength measured by 1 repetition maximum for chest press increased by a mean ( 95 % CI ) of 4.0 kg ( 0.8 to 7.2 ; p = .014 ) in the strength training group versus the relaxation group , and maximal oxygen uptake increased by 2.7 mL/kg/min ( 1.2 to 4.3 ; p = .001 ) in the aerobic group versus the relaxation group . At 4 months , the mean change in HAM-D(17 ) score was -1.3 ( -3.7 to 1.2 ; p = .3 ) and 0.4 ( -2.0 to 2.9 ; p = .3 ) for the strength and aerobic groups versus the relaxation group . At 12 months , the mean differences in HAM-D(17 ) score were -0.2 ( -2.7 to 2.3 ; p = .8 ) and 0.6 ( -1.9 to 3.1 ; p = .6 ) for the strength and aerobic groups versus the relaxation group . At 12 months , the mean differences in absence from work were -12.1 % ( -21.1 % to -3.1 % ; p = .009 ) and -2.7 % ( -11.7 % to 6.2 % ; p = .5 ) for the strength and aerobic groups versus the relaxation group . No statistically significant effect on cognitive abilities was found . CONCLUSION Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients , but they do support a beneficial effect of strength training on work capacity . TRIAL REGISTRATION ( Clinical Trials.gov ) Identifier : NCT00103415 OBJECTIVE To determine the effects of participation in a low-impact aerobic exercise program on fatigue , pain , and depression ; to examine whether intervention groups compared with a control group differed on functional ( grip strength and walk time ) and disease activity ( total joint count , erythrocyte sedimentation rate , and C-reactive protein ) measures and aerobic fitness at the end of the intervention ; and to test which factors predicted exercise participation . METHODS A convenience sample of 220 adults with rheumatoid arthritis ( RA ) , ages 40 - 70 , was r and omized to 1 of 3 groups : class exercise , home exercise using a videotape , and control group . Measures were obtained at baseline ( T1 ) , after 6 weeks of exercise ( T2 ) , and after 12 weeks of exercise ( T3 ) . RESULTS Using structural equation modeling , overall symptoms ( latent variable for pain , fatigue , and depression ) decreased significantly at T3 ( P < 0.04 ) for the class exercise group compared with the control group . There were significant interaction effects of time and group for the functional measures of walk time and grip strength : the treatment groups improved more than the control group ( P < or= 0.005 ) . There were no significant increases in measures of disease activity . Fatigue and perceptions of benefits and barriers to exercise affected participants ' amount of exercise , supporting previous research . CONCLUSION This study supported the positive effects of exercise on walk time and grip strength , and demonstrated that fatigue and perceived benefits /barriers to exercise influenced exercise participation . Furthermore , overall symptoms of fatigue , pain , and depression were positively influenced in this selective group of patients with RA ages 40 - 70 years Depression is a common condition among long-term care residents with limited treatment options available . There are few nonpharmacological interventions available to this population . This study examined the use of a prescribed , therapeutic recreation-nursing intervention , wheelchair biking , for treatment of symptoms of depression in older adults in a long-term care setting . A classical experimental design was used and was guided by the Roy Adaptation Model . Forty residents were pretested for depression and r and omly assigned to two groups . A 2-week trial of biking therapy was provided to the treatment group . All participants were posttested . Findings indicated there was a statistically significant improvement in depression scores for the treatment group and no significant change for the control group . This study contributes to the body of knowledge of nursing regarding options for the treatment of depression in older adults , and is an encouraging indicator that psychosocial interventions may be effective in reducing depression One hundred six postmyocardial infa rct ion subjects who either achieved a mean work load of less than seven mets on treadmill testing , who were rated as anxious and /or depressed , or who met both criteria , participated in a controlled study comparing the rehabilitation effectiveness of exercise therapy and group counseling . Each intervention lasted 12 weeks . Follow-up evaluations were scheduled at three months , six months and one year . Exercise substantially increased mean work capacity , decreased fatigue , lessened anxiety and depression , and promoted independence and sociability . Counseling substantially reduced depression and promoted a sense of friendliness , and decreased interpersonal friction as well as greater independence and sociability . The control group reported no substantial change on any measured factor . Neither counseling nor exercise had an effect on mortality though subjects in the exercise group reported fewer major cardiovascular sequelae OBJECTIVE To test the hypothesis that a structured aerobic exercise regimen would decrease the severity of depressive symptoms in people with traumatic brain injury ( TBI ) who reported at least mild depression severity at baseline . DESIGN Prospect i ve , r and omized , controlled trial . SETTING Community gymnasium . PARTICIPANTS Subjects with a history of a prior TBI ( 6 months to 5 years post-injury ) , recruited from the community . Inclusion criteria included scoring ≥ 5 on the Patient Health Question naire-9 . Subjects were excluded if they were non-English speakers , had a medical condition precluding exercise , had suicidal ideation , regularly exercised , or could not use st and ard aerobic exercise equipment . INTERVENTION Weekly supervised exercise sessions over a 10-week period consisted of education , warm-up , 30 minutes of aerobic exercise , and cool down . The exercise intensity was adjusted to reach a heart rate goal of 60 % of the participant 's estimated maximal heart rate . MAIN OUTCOME MEASUREMENT Beck Depression Inventory ( BDI ) comparing exercise to control groups . Post hoc analyses compared groups exercising ≥ 90 minutes or < 90 minutes per week . RESULTS Between-group comparisons at 10 weeks revealed no difference between groups on the BDI ( P = .250 ) . For the groups divided by minutes exercised per week , the high-activity group had significantly better depression scores than those in the low-activity group ( P = .033 ) . CONCLUSIONS Although there was no statistically significant difference between the treated and the control group on mood after intervention , those persons with TBI who recounted higher levels of exercise per week also reported less depression and improved sleep , community participation , and overall quality of life BACKGROUND A blunted growth hormone and prolactin response to pharmacological stress test have previously been found in depressed patients , as well as an increased cortisol response to psychosocial stress . This study investigated these hormones in response to acute exercise using an incremental bicycle test . METHOD A cross-sectional comparison of cortisol , growth hormone , and prolactin in depressed ( n=137 ) and healthy ( n=44 ) subjects during rest and in response to an incremental bicycle test . Secondly , we tested the depressed patients again after a 4-month r and omized naturalistic exercise intervention . RESULTS Resting plasma levels of growth hormone ( GH ) , cortisol , or prolactin ( PRL ) did not differ between depressed and healthy subjects ( all p-values>.12 ) . In response to an incremental bicycle test the GH ( p=.02 ) and cortisol ( p=.05 ) response in depressed was different compared to healthy controls . The effect of acute exercise stress on PRL ( p=.56 ) did not differ between depressed and healthy subjects . Apart from a decrease in GH response in the strength-training group ( p=.03 ) the pragmatic exercise intervention did not affect resting hormonal levels , or the response to acute exercise . CONCLUSIONS Patients with mild to moderate depression had a different growth hormone and cortisol response to acute exercise stress compared to healthy controls . Strength training was able to reduce the growth hormone response to acute exercise stress in this patient population . Studies with more rigorous inclusion criteria and higher exercise frequencies are needed to evaluate and confirm the possible effect of exercise in depressed subjects OBJECTIVES To determine whether tango dancing is as effective as mindfulness meditation in reducing symptoms of psychological stress , anxiety and depression , and in promoting well-being . DESIGN This study employed analysis of covariance ( ANCOVA ) and multiple regression analysis . PARTICIPANTS Ninety-seven people with self-declared depression were r and omised into tango dance or mindfulness meditation classes , or to control/waiting-list . SETTING classes were conducted in a venue suitable for both activities in the metropolitan area of Sydney , Australia . INTERVENTIONS Participants completed six-week programmes ( 1½h/week of tango or meditation ) . The outcome measures were assessed at pre-test and post-test . MAIN OUTCOME MEASURES Depression , Anxiety and Stress Scale ; The Self Esteem Scale ; Satisfaction with Life Scale , and Mindful Attention Awareness Scale . RESULTS Sixty-six participants completed the program and were included in the statistical analysis . Depression levels were significantly reduced in the tango ( effect size d=0.50 , p=.010 ) , and meditation groups ( effect size d=0.54 , p=.025 ) , relative to waiting-list controls . Stress levels were significantly reduced only in the tango group ( effect size d=0.45 , p=.022 ) . Attending tango classes was a significant predictor for the increased levels of mindfulness R(2)=.10 , adjusted R(2)=.07 , F (2,59)=3.42 , p=.039 . CONCLUSION Mindfulness-meditation and tango dance could be effective complementary adjuncts for the treatment of depression and /or inclusion in stress management programmes . Subsequent trials are called to explore the therapeutic mechanisms involved BACKGROUND Many older people living in care homes ( long term residential care or nursing homes ) are depressed . Exercise is a promising non-drug intervention for preventing and treating depression in this population . OBJECTIVE To evaluate the impact of a ' whole-home ' intervention , consisting of training for residential and nursing home staff backed up with a twice-weekly , physiotherapist-led exercise class on depressive symptoms in care home residents . DESIGN A cluster r and omised controlled trial with a cost-effectiveness analysis to compare ( 1 ) the prevalence of depression in intervention homes with that in control homes in all residents contributing data 12 months after homes were r and omised ( cross-sectional analysis ) ; ( 2 ) the number of depressive symptoms at 6 months between intervention and control homes in residents who were depressed at pre-r and omisation baseline assessment ( depressed cohort comparison ) ; and ( 3 ) the number of depressive symptoms at 12 months between intervention and control homes in all residents who were present at pre-r and omisation baseline assessment ( cohort comparison ) . SETTING Seventy-eight care homes in Coventry and Warwickshire and north-east London . PARTICIPANTS Care home residents aged ≥ 65 years . INTERVENTIONS Control intervention : Depression awareness training programme for care home staff . Active intervention : A ' whole-home ' exercise intervention , consisting of training for care home staff backed up with a twice-weekly , physiotherapist-led exercise group . MAIN OUTCOME MEASURES Geriatric Depression Scale-15 , proxy European Quality of Life-5 Dimensions ( EQ-5D ) , cost-effectiveness from an National Health Service perspective , peripheral fractures and death . RESULTS We recruited a total of 1054 participants . Cross-sectional analysis : We obtained 595 Geriatric Depression Scale-15 scores and 724 proxy EQ-5D scores . For the cohort analyses we obtained 765 baseline Geriatric Depression Scale-15 scores and 776 proxy EQ-5D scores . Of the 781 who we assessed prior to r and omisation , 765 provided a Geriatric Depression Scale-15 score . Of these 374 ( 49 % ) were depressed and constitute our depressed cohort . Re source -use and quality -adjusted life-year data , based on proxy EQ-5D , were available for 798 residents recruited prior to r and omisation . We delivered 3191 group exercise sessions with 31,705 person attendances and an average group size of 10 ( 5.3 study participants and 4.6 non- study participants ) . On average , our participants attended around half of the possible sessions . No serious adverse events occurred during the group exercise sessions . In the cross-sectional analysis the odds for being depressed were 0.76 [ 95 % confidence interval ( CI ) 0.53 to 1.09 ] lower in the intervention group at 12 months . The point estimates for benefit for both the cohort analysis ( 0.13 , 95 % CI -0.33 to 0.60 ) and depressed cohort ( 0.22 , 95 % CI -0.52 to 0.95 ) favoured the control intervention . There was no evidence of differences in fracture rates or mortality ( odds ratio 1.07 , 95 % CI 0.79 to 1.48 ) between the two groups . There was no evidence of differences in the other outcomes between the two groups . Economic analysis : The additional National Health Service cost of the OPERA intervention was £ 374 per participant ( 95 % CI -£655 to £ 1404 ) ; the mean difference in quality -adjusted life-year was -0.0014 ( 95 % CI -0.0728 to 0.0699 ) . The active intervention was thus dominated by the control intervention , which was more effective and less costly . CONCLUSION The results do not support the use of a whole-home physical activity and moderate-intensity exercise programme to reduce depression in care home residents . TRIAL REGISTRATION Current Controlled Trials IS RCT N43769277 . FUNDING This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 17 , No. 18 . See the Health Technology Assessment programme website for further project information BACKGROUND Clinical guidance recommends physical activity to manage patients with persistent subthreshold depressive symptoms or mild-to-moderate depression . However , little is known regarding the acceptability of physical activity as a treatment for depression from patients ' perspective . AIM To explore patients ' views of physical activity for the treatment of depression in the context of primary care . DESIGN OF STUDY In-depth interviews were held with 33 participants taking part in a r and omised controlled trial assessing the effectiveness of physical activity for the management of depression . SETTING Primary care . RESULTS Most participants perceived physical activity to be an acceptable treatment for depression . The mechanisms by which physical activity could enhance mood were attributed to a number of subjective benefits including biochemical pathways , providing a source of distraction from negative thoughts , and a sense of purpose . Participants who expressed a belief that their depression was caused by biochemical mechanisms reported activity that ' raised the heartbeat ' as most beneficial , while those who believed depression was situational in origin tended to state the benefits of less-aerobic activities , such as walking . Many participants reported low motivation and a lack of confidence as barriers to undertaking physical activity . These patients suggested that medication could be helpful for initiating and maintaining activity . CONCLUSION Patients view physical activity as an effective treatment for depression . However , they vary in their views about how physical activity might impact on depression , what intensity and form of activity is necessary to enhance mood , and the barriers to undertaking activity . This variation suggests the need for GPs to elicit patients ' views on physical activity as a treatment , and offer interventions that are tailored to the needs and expectations of individual patients BACKGROUND Mechanical neck pain is a common condition that affects an estimated 70 % of persons at some point in their lives . Little research exists to guide the choice of therapy for acute and subacute neck pain . OBJECTIVE To determine the relative efficacy of spinal manipulation therapy ( SMT ) , medication , and home exercise with advice ( HEA ) for acute and subacute neck pain in both the short and long term . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00029770 ) SETTING 1 university research center and 1 pain management clinic in Minnesota . PARTICIPANTS 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks . INTERVENTION 12 weeks of SMT , medication , or HEA . MEASUREMENTS The primary outcome was participant-rated pain , measured at 2 , 4 , 8 , 12 , 26 , and 52 weeks after r and omization . Secondary measures were self-reported disability , global improvement , medication use , satisfaction , general health status ( Short Form-36 Health Survey physical and mental health scales ) , and adverse events . Blinded evaluation of neck motion was performed at 4 and 12 weeks . RESULTS For pain , SMT had a statistically significant advantage over medication after 8 , 12 , 26 , and 52 weeks ( P ≤ 0.010 ) , and HEA was superior to medication at 26 weeks ( P = 0.02 ) . No important differences in pain were found between SMT and HEA at any time point . Results for most of the secondary outcomes were similar to those of the primary outcome . LIMITATIONS Participants and providers could not be blinded . No specific criteria for defining clinical ly important group differences were prespecified or available from the literature . CONCLUSION For participants with acute and subacute neck pain , SMT was more effective than medication in both the short and long term . However , a few instructional sessions of HEA result ed in similar outcomes at most time points . PRIMARY FUNDING SOURCE National Center for Complementary and Alternative Medicine , National Institutes of Health This study examined the effects of meridian exercise on anxiety , depression , and self-esteem of female college students in Korea . The effects of meridian exercise on anxiety , depression , and self-esteem were statistically significant ( t = -7.982 , P= .000 ; t= -8.814 , P = .000 ; t = 9.649 , P = .000 ) between the experimental and control group We compared the effectiveness of an aerobic and nonaerobic exercise in the treatment of clinical depression in women . A total of 40 women , screened on the Research Diagnostic Criteria for major or minor depressive disorder , were r and omly assigned to an 8-week running ( aerobic ) , weight-lifting ( nonaerobic ) , or wait-list control condition . Subjects were reassessed at mid- and posttreatment , and at 1- , 7- , and 12-month follow-ups . Depression was monitored by the Beck Depression Inventory , Lubin 's Depression Adjective Check List , and the Hamilton Rating Scale for Depression ; fitness level was assessed using submaximal treadmill testing . Results were remarkably consistent across measures , with both exercise conditions significantly reducing depression compared with the waitlist control condition , and generally appearing indistinguishable from each other . No significant between-group fitness changes were noted . These findings indicate that both types of exercise conditions significantly reduce depression and that these results are not dependent on achieving an aerobic effect Rejection of catheters is generally thought to be due to patients pulling out their catheters , but we found circumstantial evidence for this in only one third of cases . Some catheters with smaller balloons drop out spontaneously , perhaps owing to laxity of the pelvic floor or urethral dilatation caused by repeated catheterisation , and others are expelled forcibly , presumably owing to uninhibited contractions of the bladder . Urinary catheters may therefore drop out , be pushed out , or be pulled out . The life expectancy of catheters in this group of patients suggests the type of catheter that should be used . We recommend cheaper latex catheters and think that expensive " long life " silicon catheters are inappropriate in most long stay patients . Rejection of catheters is common in poorly mobile old people with cognitive impairment . It is associated with urethral trauma and may result in septicaemia . Long term catheterisation should therefore be considered only when other methods to promote continence and provide comfort have failed.3 Further work is needed to determine why some patients pull out their catheters and whether bladder stabilising drugs might reduce episodes of spontaneous rejection of catheters Data regarding perceived change were collected as part of a study of the effects of aerobic exercise training on psychological , cognitive , and physiological functioning among 101 healthy older adults . Subjects were assigned r and omly to an aerobic exercise group , a yoga control group , or a waiting list group for 16 weeks , after which all subjects participated in aerobic exercise for another 16 weeks . Exercise participants perceived positive changes in a wide range of significant life areas , and perceived improvement was more closely related to objective improvement for physiological indicators than for indicators of cognitive functioning or psychological well-being OBJECTIVE To examine the effect of exercise intervention on exercise maintenance , depression , quality of life , and mental health at 6 months for people with traumatic brain injury ( TBI ) with at least mild depression . DESIGN Treatment group participants were assessed at baseline , after a 10-week exercise intervention , and 6 months after completion of the intervention . SETTING Community . PARTICIPANTS Participants ( N=40 ) with self-reported TBI from 6 months to 5 years prior to study enrollment and a score of 5 or greater on the Patient Health Question naire-9 . INTERVENTIONS Ten-week exercise intervention program consisting of supervised weekly 60-minute sessions and unsupervised 30 minutes of aerobic exercises 4 times each week . Telephone follow-up was conducted every 2 weeks for an additional 6 months to promote exercise maintenance for individuals r and omized to the intervention group . MAIN OUTCOME MEASURE Beck Depression Inventory ( BDI ) comparing participant outcomes over time . Post hoc analyses included comparison among those who exercised more or less than 90 minutes per week . RESULTS Participants reduced their scores on the BDI from baseline to 10 weeks and maintained improvement over time . Many participants ( 48 % ) demonstrated increased physical activity at 6 months compared with baseline . Those who exercised more than 90 minutes had lower scores on the BDI at the 10-week and 6-month assessment s and reported higher perceived quality of life and mental health . CONCLUSIONS Exercise may contribute to improvement in mood and quality of life for people with TBI and should be considered as part of the approach to depression treatment Background : The first objective of this study was to compare the changes in physical self-concept , global self-esteem , depression and anxiety after participation in one of two 16-week psychomotor therapy programs for nonpsychotic psychiatric in patients . The second objective was to study the relationship between changes in these variables . Methods : One hundred and ninety-nine in patients were r and omly assigned to either a personalized psychomotor fitness program , consisting of aerobic exercise and weight training , or a general program of psychomotor therapy , consisting of different forms of physical exercises and relaxation training . Physical self-con cept was evaluated using the Dutch version of the Physical Self-Perception Profile at baseline , after 8 weeks , and after completion of the 16-week interventions . At the same time points , additional variables of global self-esteem , depression and anxiety were assessed by means of the Rosenberg Self-Esteem Inventory , the Beck Depression Inventory and the Trait Anxiety Inventory , respectively . Results : After 16 weeks , both groups showed significant improvements in all outcome measures ( p values ranged from 0.01 to < 0.0001 ) , with no between-group differences . In both groups , the improvement in physical self-concept was correlated with increased global self-esteem and decreased depression and anxiety levels ( p < 0.01 ) . Conclusions : The results suggest that both psychomotor therapy programs are equally effective in enhancing physical self-concept . The relationship between improvements in physical self-concept and enhancements in global self-esteem , depression and anxiety supports the potential role of the physical self-concept in the recovery process of depressed and anxious psychiatric in patients AIMS To assess the effect of lifestyle intervention on depressive symptoms during a 36-month r and omized clinical trial design ed to prevent Type 2 diabetes . METHODS A total of 522 middle-aged participants , who were overweight or obese and had impaired glucose tolerance , were r and omized to the lifestyle intervention or control group in the Finnish Diabetes Prevention Study . The intervention group received individualized counselling aim ed at reducing weight and increasing physical activity . Depressive symptoms were measured using the Beck Depression Inventory among a subgroup of 140 participants . RESULTS On study entry , the mean Beck Depression Inventory scores ± sd were 6.8 ± 5.6 in the intervention group and 6.7 ± 5.5 in the control group . Beck Depression Inventory scores reduced during the intervention study : the mean ± sd ( 95 % CI ) reduction was 0.90 ± 4.54 ( -1.99 to -0.19 ) scores in the intervention group and 0.75 ± 4.47 ( -1.80 to 0.31 ) in the control group , with no difference between the groups . In a stepwise linear multivariate regression analysis , the variables with the strongest associations with the change in Beck Depression Inventory scores were baseline Beck Depression Inventory scores , marital status , weight change and change of total energy intake ( R(2 ) = 0.209 , P < 0.001 ) . CONCLUSIONS Participation in the study lowered depression scores , with no specific group effect . Among the lifestyle changes , particularly successful reduction of body weight was associated with the greater reduction of depressive symptoms . Thus , regardless of the intensity of the treatment , the success in executing alterations in one 's lifestyle and behaviour is associated with beneficial changes in mood BACKGROUND Pharmacological treatment of depression in geriatric patients is often difficult . Although unsupervised exercise has been shown to benefit younger depressed patients , there is no evidence that unsupervised exercise can be used as a maintenance treatment for depression in elderly patients . Our aim was to test the feasibility and efficacy of unsupervised exercise as a long-term treatment for clinical depression in elderly patients . METHODS We studied 32 subjects ( 71.3 + /- 1.2 years of age , mean + /- SE ) in a 20-week , r and omized , controlled trial , with follow-up at 26 months . Subjects were community-dwelling patients with major or minor depression or dysthymia . Exercisers engaged in 10 weeks of supervised weight-lifting exercise followed by 10 weeks of unsupervised exercise . Controls attended lectures for 10 weeks . No contact was made with either group after 20 weeks until final follow-up . Blinded assessment was made with the Beck Depression Inventory ( BDI ) , the Philadelphia Geriatric Morale Scale , and Ewart 's Self Efficacy Scale at 20 weeks and with the BDI and physical activity question naire at 26 months . RESULTS Patients r and omized to the exercise condition completed 18 + /- 2 sessions of unsupervised exercise during Weeks 10 to 20 . The BDI was significantly reduced at both 20 weeks and 26 months of follow-up in exercisers compared with controls ( p < .05-.001 ) . At the 26-month follow-up , 33 % of the exercisers were still regularly weight lifting , versus 0 % of controls ( p < .05 ) . CONCLUSIONS Unsupervised weight-lifting exercise maintains its antidepressant effectiveness at 20 weeks in depressed elderly patients . Long-term changes in exercise behavior are possible in some patients even without supervision QUESTION Does supervised aerobic exercise during pregnancy reduce depressive symptoms in nulliparous women ? DESIGN R and omised trial with concealed allocation , blinded assessors , and intention-to-treat analysis . PARTICIPANTS 80 nulliparous , pregnant women attending for prenatal care at one of three tertiary hospitals in Cali , Colombia . INTERVENTION The experimental group completed a 3-month supervised exercise program , commencing at 16 to 20 weeks of gestation . Each session included walking ( 10 min ) , aerobic exercise ( 30 min ) , stretching ( 10 min ) , and relaxation ( 10 min ) . The control group continued usual activities and performed no specific exercise . OUTCOME MEASURES The primary outcome was symptoms of depression assessed by the Center for Epidemiological Studies Depression Scale ( CES-D ) at baseline and immediately after the 3-month intervention . RESULTS 74 women completed the study . After the 3-month intervention , the experimental group reduced their depressive symptoms on the CES-D question naire by 4 points ( 95 % CI 1 to 7 ) more than the control group . CONCLUSIONS A supervised 3-month program of primarily aerobic exercise during pregnancy reduces depressive symptoms . TRIAL REGISTRATION NCT00872365 OBJECTIVES To test the feasibility and efficacy of current guidelines for multimodal exercise programs in older adults . DESIGN R and omized , controlled trial . SETTING Retirement village . PARTICIPANTS Thirty-eight subjects ( 14 men and 24 women ) aged 76.6 + /- 6.1 . INTERVENTION A wait list control or 10 weeks of supervised exercise consisting of high-intensity ( 80 % of one-repetition maximum ( 1RM ) ) progressive resistance training ( PRT ) 3 days per week , moderate-intensity ( rating of perceived exertion 11 to 14/20 ) aerobic training 2 days per week , and progressive balance training 1 day per week . MEASUREMENTS Blinded assessment s of dynamic muscle strength ( 1RM ) , balance , 6-minute walk , gait velocity , chair st and , stair climb , depressive symptoms , self-efficacy , and habitual physical activity level . RESULTS Higher baseline strength and psychological well-being were associated with better functional performance . Strength gains over 10 weeks averaged 39+/-31 % in exercise , versus 21+/-24 % in controls ( P=.10 ) , with greater improvements in hip flexion ( P=.01 ) , hip abduction ( P=.02 ) , and chest press ( P=.04 ) in the exercise group . Strength adaptations were greatest in exercises in which the intended continuous progressive overload was achieved . Stair climb power ( 12.3+/-15 % , P=.002 ) and chair st and time ( -7.1+/-15 % , P=.006 ) improved significantly and similarly in both groups . Reduction in depressive symptoms was significantly related to compliance ( attendance rate r=-0.568 , P=.009 , PRT progression in loading r=-0.587 , P=.02 , and total volume of aerobic training r=-0.541 , P=.01 ) , as well as improvements in muscle strength ( r=-0.498 , P=.002 ) . CONCLUSION Robust physical and psychological adaptations to exercise are linked , although volumes and intensities of multiple exercise modalities sufficient to cause significant adaptation appear difficult to prescribe and adhere to simultaneously in older adults Forty clinical ly depressed women were r and omized to a running , weight lifting , or delayed treatment condition . Self-concept was assessed at baseline , pre- , mid- , and posttreatment for all subjects and at 1 , 7 , and 12 months for exercise groups . Significant improvements in self-concept were found for exercise groups relative to control groups . No significant differences between exercise groups were found , and improvements were reasonably well-maintained over time . Differential changes on dimensions of self-concept were not demonstrated . These results suggest that both running and weight lifting exercise programs improve self-concept in clinical ly depressed women Background : This prospect i ve , r and omized controlled trial examined the effect of progressive muscle relaxation ( PMR ) training on anxiety and depression in patients with chronic breathing disorders receiving pulmonary rehabilitation ( PR ) . Methods : Eighty-three subjects with chronic breathing disorders entering the 8-week PR program were r and omly assigned to a st and ard care or intervention group . The st and ard program included 2 days per week of exercise , education and psychosocial support delivered by a multidisciplinary team . The intervention group received additional sessions of PMR training using a prerecorded tape for 25 min/week during weeks 2–8 . Primary outcome measures were levels of anxiety and depression evaluated by the Hospital Anxiety and Depression Scale . Results : For anxiety , there was an overall significant improvement within each group over time ( p < 0.0001 ) . There was no statistically significant group-time interaction ( p = 0.17 ) and no statistically significant difference between the groups ( p = 0.22 ) , despite lower scores for every time point in the PMR group . For depression , there was an overall significant improvement within each group over time ( p < 0.0001 ) . Although the difference between the groups ( p = 0.09 ) and group-time interaction ( p = 0.07 ) did not reach statistical significance , the results again favored the PMR group for weeks 5–8 . Depression scores were lower for the PMR throughout weeks 1–8 . Conclusions : PR is effective in reducing anxiety and depressive level in chronic lung patients . Our findings suggest that adding structured PMR training to a well-established PR program may not confer additional benefit in the further reduction of anxiety and depression in patients receiving PR BACKGROUND Research has shown that self-directed stress management training improves mental well-being in patients undergoing chemotherapy . The present study extends this work by evaluating separate and combined effects of stress management training and home-based exercise . METHOD Following assessment of mental and physical well-being , depression , anxiety , exercise , and stress reduction activity before chemotherapy started , patients were r and omized to stress management training ( SM ) , exercise ( EX ) , combined stress management and exercise ( SMEX ) , or usual care only ( UCO ) . Outcomes were reassessed 6 and 12 weeks after chemotherapy started . Significance testing of group-by-time interactions in 286 patients who completed all assessment s was used to evaluate intervention efficacy . RESULTS Interaction effects for mental and physical well-being scores were not significant . Depression scores yielded a linear interaction comparing UCO and SMEX ( p = 0.019 ) , with decreases in SMEX but not UCO . Anxiety scores yielded a quadratic interaction comparing UCO and SMEX ( p = 0.049 ) , with trends for changes in SMEX but not UCO . Additional analyses yielded quadratic interactions for exercise activity comparing UCO and SMEX ( p = 0.022 ) , with positive changes in SMEX but not UCO , and for stress management activity comparing UCO and SM ( p < 0.001 ) and UCO and SMEX ( p = 0.013 ) , with positive changes in SM and SMEX but not UCO . CONCLUSION Only the combined intervention yielded effects on quality of life outcomes , and these were limited to anxiety and depression . These findings are consistent with evidence that only the combined intervention yielded increases in both exercise and stress management activity . Future research should investigate ways to augment this intervention to enhance its benefits Depression is common in patients with heart failure ( HF ) , prognostic for adverse outcomes and purportedly related to disease severity . Psychological and physiologic factors relevant to HF were assessed in HF-ACTION , a large r and omized study of aerobic exercise training in patients with systolic HF . The relation of objective and subjective parameters was compared with scores on the Beck Depression Inventory ( BDI ) to examine the hypothesis that depressive symptoms are better associated with perception of disease severity than with objective markers of HF severity . At baseline , 2,322 of 2,331 subjects entered into HF-ACTION completed question naires to assess depression ( BDI ) and quality of life ( Kansas City Cardiomyopathy Question naire [ KCCQ ] ) . Objective markers of HF severity included ejection fraction , B-type natriuretic peptide , and peak oxygen consumption ( using cardiopulmonary exercise testing , with evaluation of duration and respiratory exchange ratio also performed ) . Measures more likely to be affected by perceived functional status included New York Heart Association ( NYHA ) classification and the 6-minute walk test . Objective assessment s of disease severity were slightly related ( peak oxygen consumption ) or not related ( B-type natriuretic peptide and ejection fraction ) to BDI scores . Using multivariate analysis ( KCCQ not included ) , only age , gender , cardiopulmonary exercise testing duration , NYHA class , 6-minute walk distance , and peak respiratory exchange ratio independently correlated with BDI scores . In conclusion , depression was minimally related to objective assessment s of severity of disease in patients with HF , but was associated with patient ( and clinician ) perceptions of disease severity . Addressing depression might improve symptoms in patients with HF BACKGROUND African American women have more symptoms of depressed mood than white women . Adverse neighborhood conditions may contribute to these symptoms . Although reductions in depressive symptoms with physical activity have been demonstrated in white adults , little research has examined the mental health benefits of physical activity in African American women . Further , it is unknown whether physical activity can offset the effects of living in disadvantaged neighborhoods on depressive symptoms . The purpose of this study was to examine the relationships among neighborhood characteristics , adherence to a physical activity intervention , and change over time in depressive symptoms in midlife African American women . METHODS Two hundred seventy-eight women participated in a home-based , 24-week moderate-intensity walking intervention . Either a minimal treatment ( MT ) or enhanced treatment ( ET ) version of the intervention was r and omly assigned to one of the two community health centers . Walking adherence was measured as the percentage of prescribed walks completed . Objective and perceived measures of neighborhood deterioration and crime were included . RESULTS Adjusting for demographics , body mass index ( BMI ) , and depressive symptoms at baseline , walking adherence and objective neighborhood deterioration were associated with significantly lower depressive symptoms , whereas perceived neighborhood deterioration was associated with significantly higher depressive symptoms at 24 weeks . CONCLUSIONS Adherence to walking as well as aspects of the environment may influence depressive symptoms in African American women . In addition to supporting active lifestyles , improving neighborhood conditions may also promote mental health among African American women Objective . To study whether exercise during pregnancy reduces the risk of postnatal depression . Design . R and omized controlled trial . Setting . Trondheim and Stavanger University Hospitals , Norway . Population and Sample . Eight hundred and fifty‐five pregnant women were r and omized to intervention or control groups . Methods . The intervention was a 12week exercise program , including aerobic and strengthening exercises , conducted between week 20 and 36 of pregnancy . One weekly group session was led by physiotherapists , and home exercises were encouraged twice a week . Control women received regular antenatal care . Main Outcome Measures . Edinburgh Postnatal Depression Scale ( EPDS ) completed three months after birth . Scores of 10 or more and 13 or more suggested probable minor and major depression , respectively . Results . Fourteen of 379 ( 3.7 % ) women in the intervention group and 17 of 340 ( 5.0 % ) in the control group had an EPDS score of ≥10 ( p=0.46 ) , and four of 379 ( 1.2 % ) women in the intervention group and eight of 340 ( 2.4 % ) in the control group had an EPDS score of ≥13 ( p=0.25 ) . Among women who did not exercise prior to pregnancy , two of 100 ( 2.0 % ) women in the intervention group and nine of 95 ( 9.5 % ) in the control group had an EPDS score of ≥10 ( p=0.03 ) . Conclusions . We did not find a lower prevalence of high EPDS scores among women r and omized to regular exercise during pregnancy compared with the control group . However , a subgroup of women in the intervention group who did not exercise regularly prior to pregnancy had a reduced risk of postnatal depression Background The Wales National Exercise Referral Scheme ( NERS ) is a 16-week programme including motivational interviewing , goal setting and relapse prevention . Method A pragmatic r and omised controlled trial with nested economic evaluation of 2160 inactive participants with coronary heart disease risk ( CHD , 1559 , 72 % ) , mild to moderate depression , anxiety or stress ( 79 , 4 % ) or both ( 522 , 24 % ) r and omised to receive ( 1 ) NERS or ( 2 ) normal care and brief written information . Outcome measures at 12 months included the 7-day physical activity recall , the hospital anxiety and depression scale . Results Ordinal regression identified increased physical activity among those r and omised to NERS compared with those receiving normal care in all participants ( OR 1.19 , 95 % CI 0.99 to 1.43 ) , and among those referred for CHD only ( OR 1.29 , 95 % CI 1.04 to 1.60 ) . For those referred for mental health reason alone , or in combination with CHD , there were significantly lower levels of anxiety ( OR −1.56 , 95 % CI −2.75 to −0.38 ) and depression ( OR −1.39 , 95 % CI −2.60 to −0.18 ) , but no effect on physical activity . The base-case incremental cost-effectiveness ratio was £ 12 111 per quality adjusted life year , falling to £ 9741 if participants were to contribute £ 2 per session . Conclusions NERS was effective in increasing physical activity among those referred for CHD risk only . Among mental health referrals , NERS did not influence physical activity but was associated with reduced anxiety and depression . Effects were dependent on adherence . NERS is likely to be cost effective with respect to prevailing payer thresholds . Trial registration Current Controlled Trials IS RCT N47680448 BACKGROUND Physical exercise has been extensively research ed as a therapeutic option for treatment of major depression . METHODS In a r and omized controlled trial , we analyze the effects of aerobic physical exercise as an add-on strategy for treatment of severe depressed in patients . The exercise has a " Dose " of 16.5 kcal/kg/week , three times a week during all the hospitalization . RESULTS Our preliminary results show that there is no significant difference in scores of Hamilton in the second week between groups ( Mean[SD]=8.2[5.96 ] × 11.18[5.03 ] , p=0.192 ) . However , there is a significant reduction in Hamilton scores of patients in exercise group at discharge ( Mean[SD]=5.93[4.46 ] × 9.45[3.56 ] , p=0.041 ) . Regarding Quality of Life ( QoL ) , no significant difference were found between groups in the second week in physical domain ( Mean[SD]=56.98[8.96 ] × 54.54[9.18 ] , p=0.511 ) and psychological domain ( Mean[SD]=50.88[13.88 ] × 42.04[12.42 ] , p=0.106 ) . However , there is a significant difference in psychological domain ( Mean[SD]=55.88[9.92 ] v 41.66[13.04 ] , p=0.004 ) and a trend but no statistical significance in the physical ( Mean[SD]=58.80[9.14 ] × 52.12[8.70 ] , p=0.07 ) at discharge . LIMITATIONS Many patients receive different treatment strategies , like ECT ( 1 patient at exercise group × 3 at control group ) . Other limitation is the small number of participants included until this moment . CONCLUSION Our preliminary results suggest that physical exercise could be a feasible and effective add-on strategy for treatment of severe depressed in patients , improving their depressive symptoms and Two clinical trials have been conducted in a sample of depressed patients to determine whether the addition of an aerobic exercise programme to their usual treatment improved outcome after 12 weeks . In the first trial , an aerobic exercise group had a superior outcome compared with a control group in terms of trait anxiety and a st and ard psychiatric interview . A second trial was then conducted to compare an aerobic exercise programme with low intensity exercise . Both groups showed improvement but there were no significant differences between the groups . In neither trial was there any correlation between the extent of change in the subjects ' physical fitness due to aerobic exercise and the extent of the improvement of psychiatric scores BACKGROUND Patients with chronic renal failure ( CRF ) are restricted in physical , emotional and social dimensions of life due to their treatment and their comorbid medical conditions . We aim ed to evaluate the effects of a 12-week exercise program on the functional capacity , functional mobility , walking capacity , quality of life and depression in patients with renal failure on hemodialysis ( HD ) . METHODS Twenty patients with renal failure on HD were included and 14 of them completed the study . The patients went through a 12-week exercise program of 90 min/day , 3 days a week . Exercise and walking capacity , functional mobility , psychological status and quality of life were evaluated pre- and post-training . RESULTS Following the exercise , peak oxygen consumption , exercise duration and peak workload improved significantly ( respectively , p=0.006 , p=0.002 and p=0.002 ) . There were significant improvements in the sit-to-st and -to-sit test and the 6- min walk test ( p<0.001 and p=0.002 ) . There was a significant reduction in the depression score ( p<0.001 ) . Both physical component scale ( PCS ) and mental component scale ( MCS ) of the Kidney Disease Quality of Life Short-Form 36 ( SF-36 ) question naire showed significant increases ( respectively , p=0.002 and p=0.004 ) . CONCLUSION The application of an appropriate exercise program would improve psychological status and quality of life , as well as work capacity in long-term maintenance HD patients BACKGROUND Treatment-resistant major depressive disorder ( MDD ) is a complex condition , with very low remission rates . Physical exercise has been used , with some encouraging results , as an alternative therapy in other depressive disorders . This study assessed the impact on depression and functioning parameters of a moderate intensity exercise program , as an adjuvant to pharmacotherapy , in treatment-resistant MDD patients . METHODS 150 individuals with treatment-resistant MDD , defined as taking combined therapy in doses considered adequate for 9 - 15 months , without showing clinical remission , were initially screened . 33 were r and omized to one of two groups : usual pharmacotherapy ( N = 11 ) and usual pharmacotherapy plus aerobic exercise ( N = 22 ) . The exercise program consisted of home-based 30 - 45 min/day walks , 5 days/week , for 12 weeks , being 1 walk per week supervised . RESULTS The exercise group showed improvement of all depression and functioning parameters , as indicated by lower HAMD17 , BDI and CGI-S and higher GAF ( p < 0.05 ) at last observation compared both to baseline values and to control group . At the end of the study none of the participants in the control group showed response or remission , whilst in the exercise group 21 % of participants showed response and 26 % remission , although these differences were not statistically significant . CONCLUSION A 12 week , home-based exercise program of 30 - 45 min/day walks , 5 days/week , improved depression and functioning parameters in treatment-resistant MDD patients , and contributed to remission of 26 % of these patients . Moderate intensity exercise may be a helpful and effective adjuvant therapy for treatment-resistant MDD Increasing evidence suggests that physical activity can prevent some aspects of mental illness in older people such as depression , dementia and Alzheimer ’s disease . Additionally , limited research has shown that engagement in structured exercise can improve aspects of psychological well-being such as mood and self-perceptions in older adults . However , the relationship between incidental daily activity such as walking or time spent sedentary , with psychological well-being has not been investigated . The Better Ageing Project provided an opportunity to assess well-being and quality of life using st and ardised question naires with 176 adults aged 70 and over . Accelerometry was used to objective ly assess daily energy expended in physical activity at different levels of intensity . In addition , an assessment of the impact of the 12-month Better Ageing structured group exercise programme was assessed through question naires and interviews . Total daily physical activity energy expenditure ( joules/day ) and amount of time spent in activity of at least moderate intensity were weakly related ( r = 0.20–0.28 ) to quality of life , subjective well-being and physical self-perceptions . Time spent sedentary ( min/day ) was weakly and negatively related to several mental health indicators . The quantitative data showed only minor psychological benefits of the exercise intervention . In contrast , interviews with 27 research participants and 4 exercise leaders suggested that important improvements in perceived function and social benefits had been experienced The purpose of this study was to determine the effects a health education and exercise program would have in limiting weight gain and in improving fitness and psychological parameters in adults with mood or psychotic disorders . Thirty volunteers were r and omly assigned to the healthy lifestyle group ( HL ) or a control group . The HL group engaged in exercise for 12 weeks . Pre- and post-exercise testing was conducted to assess body fat , lipid profile , and cardiovascular fitness . Educational seminars were held weekly . The intervention group evidence d greater weight loss than the control group , although not statistically significant . Significant differences were observed in ratings of general health ( p < .05 ) and empowerment ( p < .01 ) . Trends suggest that exercise interventions may encourage weight loss , particularly if barriers to full participation can be addressed . Additionally , such interventions may contribute to " perceived " well-being even among those with sub clinical participation Brain-derived neurotrophic factor ( BDNF ) and other neurotrophins are believed to play an important role in affective disorders . In this study we investigated plasma-BDNF response during an incremental exercise test in 18 patients suffering from moderate major depressive disorder ( MDD ) and 18 controls . The patients were not treated with antidepressants or neuroleptics . Possible associations between plasma plasma-BDNF levels , dexamethasone suppression test cortisol levels and Montgomery-Asberg Depression Rating Scale ( MADRS ) scores were also tested . No difference in basal BDNF levels between patients and controls was found . BDNF increased significantly during exercise in both male and female patients as well as in male controls , with no significant differences between the groups . BDNF levels declined after exercise , but after 60 min of rest BDNF levels showed tendencies to increase again in male patients . No correlation between BDNF and cortisol or MADRS scores was found . We conclude that unmedicated patients with moderate depression and normal activity of the hypothalamic-pituitary-adrenal axis do not have a disturbed peripheral BDNF release during exercise . The BDNF increase 60 min after interruption of exercise in male patients might indicate up-regulated BDNF synthesis , but this needs to be further investigated in future studies OBJECTIVE The onset of action of antidepressants often takes 4 to 6 weeks . The antidepressant effect of wake therapy ( sleep deprivation ) comes within hours but carries a risk of relapse . The objective of this study was to investigate whether a new chronotherapeutic intervention combining wake therapy with bright light therapy and sleep time stabilization could induce a rapid and sustained augmentation of response and remission in major depressive disorder . METHOD 75 adult patients with DSM-IV major depressive disorder , recruited from psychiatric wards , psychiatric specialist practice s , or general medical practice s between September 2005 and August 2008 , were r and omly assigned to a 9-week chronotherapeutic intervention using wake therapy , bright light therapy , and sleep time stabilization ( n = 37 ) or a 9-week intervention using daily exercise ( n = 38 ) . Patients were evaluated at a psychiatric research unit . The study period had a 1-week run-in phase in which all patients began treatment with duloxetine . This phase was followed by a 1-week intervention phase in which patients in the wake therapy group did 3 wake therapies in combination with daily morning light therapy and sleep time stabilization and patients in the exercise group began daily exercise . This phase was followed by a 7-week continuation phase with daily light therapy and sleep time stabilization or daily exercise . The 17-item Hamilton Depression Rating Scale was the primary outcome measure , and the assessors were blinded to patients ' treatment allocation . RESULTS Both groups responded well to treatment . Patients in the wake therapy group did , however , have immediate and clinical ly significantly better response and remission compared to the exercise group . Thus , immediately after the intervention phase ( week 2 ) , response was obtained in 41.4 % of wake therapy patients versus 12.8 % of exercise patients ( odds ratio [ OR ] = 4.8 ; 95 % CI , 1.7 - 13.4 ; P = .003 ) , and remission was obtained in 23.9 % of wake therapy patients versus 5.4 % of exercise patients ( OR = 5.5 ; 95 % CI , 1.7 - 17.8 ; P = .004 ) . These superior response and remission rates obtained by the wake therapy patients were sustained for the whole study period . At week 9 , response was obtained in 71.4 % of wake therapy patients versus 47.3 % of exercise patients ( OR = 2.8 ; 95 % CI , 1.1 - 7.3 ; P = .04 ) , and remission was obtained in 45.6 % of wake therapy patients and 23.1 % of exercise patients ( OR = 2.8 ; 95 % CI , 1.1 - 7.3 , P = .04 ) . All treatment elements were well tolerated . CONCLUSIONS Patients treated with wake therapy in combination with bright light therapy and sleep time stabilization had an augmented and sustained antidepressant response and remission compared to patients treated with exercise , who also had a clinical ly relevant antidepressant response . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00149110 BACKGROUND In western countries , the yearly incidence of depression is estimated to be 3 - 5 % and the lifetime prevalence is 17 % . In patient population s with chronic diseases the point prevalence may be 20 % . Depression is associated with increased risk for various conditions such as osteoporoses , cardiovascular diseases , and dementia . WHO stated in 2000 that depression was the fourth leading cause of disease burden in terms of disability . In 2000 the cost of depression in the US was estimated to 83 billion dollars . A predominance of trials suggests that physical exercise has a positive effect on depressive symptoms . However , a meta- analysis from 2001 stated : " The effectiveness of exercise in reducing symptoms of depression can not be determined because of a lack of good quality research on clinical population s with adequate follow-up . " OBJECTIVES The major objective for this r and omized trial is to compare the effect of non-aerobic , aerobic , and relaxation training on depressive symptoms using the blindly assessed Hamilton depression scale ( HAM-D(17 ) ) as primary outcome . The secondary outcome is the effect of the intervention on working status ( i.e. , lost days from work , employed/unemployed ) and the tertiary outcomes consist of biological responses . DESIGN The trial is design ed as a r and omized , parallel-group , observer-blinded clinical trial . Patients are recruited through general practitioners and psychiatrist and r and omized to three different interventions : 1 ) non-aerobic , -- progressive resistance training , 2 ) aerobic training , -- cardio respiratory fitness , and 3 ) relaxation training with minimal impact on strength or cardio respiratory fitness . Training for all three groups takes place twice a week for 4 months . Evaluation of patients ' symptoms takes place four and 12 months after inclusion . The trial is design ed to include 45 patients in each group . Statistical analysis will be done as intention to treat ( all r and omized patients ) . Results from the DEMO trial will be reported according to the CONSORT guidelines in 2008 - 2009 This experiment investigated the effects of three types of structured exercise ( aerobics , bodybuilding , and circuit training ) on depressive symptoms of 45 clients undergoing a 4-wk . , inpatient rehabilitation program for substance abuse . Pre- and posttest measures included the Center of Epidemiological Studies —Depression , resting pulse rate , blood pressure , maximum strength on incline bench press , and estimates of aerobic fitness and body fat . The bodybuilding program produced a significant decrease in depressive symptoms . Physiological and psychological explanations are discussed Forty-three depressed women were r and omly assigned to either ( a ) an aerobic exercise treatment condition in which they participated in strenuous exercise , ( b ) a placebo treatment condition in which they practice d relaxation exercises , or ( c ) a no-treatment condition . Aerobic capacity was assessed before and after the 10-week treatment period . Self-reported depression was assessed before , during , and after the treatment period . The results indicated that subjects in the aerobic exercise condition evidence d reliably greater improvements in aerobic capacity than did the subjects in either of the other conditions ( p less than .002 in both cases ) and that the subjects in the aerobic exercise condition evidence d reliably greater decreases in depression than did subjects in the placebo condition ( p = .05 ) or subjects in the no-treatment condition ( p = .001 ) . These results provide the first controlled evidence concerning the effects of strenuous exercise on depression Research has revealed that exercise is effective for reducing symptoms of depression and anxiety . The mechanisms by which these reductions occur , however , have not been widely studied . To examine several potential theories , a prospect i ve , r and omized , 7-week exercise intervention was conducted . Untrained participants were r and omly assigned to an aerobic exercise group or to a stretching-control group . Participants completed several question naires to assess psychological variables , including measures of depression and anxiety , and blood was drawn at pre- and post-test to measure serum serotonin levels . A mixed- design ANOVA revealed that the exercise group had lower levels of depression than the stretching-control group after the intervention . The exercise group also showed a larger percentage decrease in serotonin than the stretching-control group . This reduction in blood serotonin after exercise is similar to the effects of selective serotonin reuptake inhibitors . Additionally , percent change in serotonin was found to partially mediate the relationship between exercise and depression Objective : To compare the changes in cardiorespiratory and muscular fitness , and the changes in physical self-concept after participation in one of two psychomotor therapy programmes in a sample group of psychiatric patients . To study the relationship between the changes in physical fitness and the changes in physical self-concept . Design : R and omized controlled parallel-group trial with repeated measures . Setting : Three treatment units of a university psychiatric hospital in Belgium . Subjects : One hundred and ninety-nine patients with severe symptoms of depression and /or anxiety , and /or personality disorders . Interventions : A general programme of psychomotor therapy , consisting of different forms of physical exercises and relaxation training , and a personalized psychomotor fitness programme , consisting of aerobic and resistance training . These programmes were followed three times a week for a period of 16 weeks . Outcome measures : The maximum dynamic strength , the strength endurance , physical work capacity at 60 % and 80 % of the estimated maximal heart rate reserve , and the physical self-concept by means of the Dutch version of the Physical Self-Perception Profile . Results : After eight weeks , both groups exhibited an improvement in muscular fitness ( both p-values < 0.0001 ) , but only the psychomotor fitness group had improved in cardiorespiratory fitness ( p < 0.01 ) . After 16 weeks , the patients in the general programme of psychomotor therapy had not increased in cardiorespiratory fitness . At the end of the 16-week programmes , both groups showed a more positive physical self-concept ( p from 0.01 to < 0.0001 ) . However , these improvements were not related to the progress in physical fitness . Conclusions : The main difference in the effectiveness of the two programmes was the increase in cardiorespiratory fitness in the psychomotor fitness group . The gains in fitness did not play an essential role in the enhancement of physical self-concept OBJECTIVES To examine the effects of physical activity counseling on mood among older people unselected for their depressive symptomatology . METHODS Data are from " Screening and Counseling for Physical Activity and Mobility in Older People " project ( SCAMOB ) , conducted in Finl and during 2003 - 2005 . SCAMOB was a 2-year single-blinded r and omized controlled trial among 624 participants 75 years and older r and omized into physical activity counseling group and control group . Depressive symptoms were assessed at baseline and after 24 months using Center for the Epidemiologic Studies Depression Scale . RESULTS Among all the study participants , no effect of intervention was observed . However , among subgroup with minor depressive symptoms at baseline , a significant treatment effect was observed , where depressive symptoms decreased in the intervention group and increased in the control group . CONCLUSIONS These findings suggest that physical activity counseling may reduce depression among those with minor depressive symptoms , which warrants for future studies Psychosocial factors predicting treatment dropout or failure to benefit from treatment were identified in a r and omized trial of exercise therapy and pharmacotherapy for major depression . One hundred fifty-six men and women over age 50 diagnosed with major depressive disorder were assigned to a 16-week program of aerobic exercise , medication ( sertraline ) , or a combination of exercise and medication . Thirty-two patients ( 21 % ) failed to complete the program and were considered treatment " dropouts . " At the end of 16 weeks , 83 patients ( 53 % ) were in remission ; the remaining patients not in remission were considered treatment " failures . " Baseline levels of self-reported anxiety and lift satisfaction were the best predictors of both patient dropout and treatment success or failure across all treatment conditions Aerobic exercise training may help prevent or reduce depressive symptoms experienced by persons living with HIV infection . However , the psychological effects of aerobic exercise have not been studied extensively . This study evaluated the effects of an aerobic exercise training program on self-reported symptoms of depression in HIV-infected adults and examined the convergent validity of two widely used depressive symptom scales . Sixty HIV-infected adults participated in a r and omized , controlled trial of a supervised 12-week aerobic exercise training program . As compared to study controls , exercise participants showed reductions in depressive symptoms on all indices , and total depressive symptoms scores were highly correlated . Additional study of the psychological effects of aerobic exercise programs in the target population is recommended PURPOSE : The primary aim of this study was to evaluate if pulmonary rehabilitation in a subtropical climate during winter had better long-term effects on health-related quality of life and symptoms of anxiety and depression than an equivalent pulmonary rehabilitation program in a colder climate . The secondary aim was to assess short-term differences in the same outcomes . METHODS : Referred patients with chronic obstructive pulmonary disease were r and omized to and completed rehabilitation in a subtropical climate in Spain ( n = 60 ) or in a temperate climate in Norway ( n = 36 ) . Health-related quality of life was assessed with St. George 's Respiratory Question naire , and symptoms of anxiety and depression were assessed with the Hospital Anxiety and Depression Scale at the start of rehabilitation , at discharge , and 8 months later . RESULTS : There were no significant differences between the 2 groups in mean changes in St George 's Respiratory Question naire dimensions or total score ( −3.0 ; 97.5 % confidence interval [ CI ] , −8.6 to 2.6 , P = .22 ) or Hospital Anxiety and Depression Scale anxiety ( −1.2 ; 97.5 % CI , −2.7 to 0.3 , P = .08 ) or depression ( −0.3 ; 97.5 % CI , −1.7 to 1.1 , P = .62 ) score from the start of rehabilitation to 9 months thereafter . During rehabilitation , the Spain group improved more than the Norway group in the activity score of the St George 's Respiratory Question naire ( −6.2 ; 97.5 % CI , −12.4 to −0.1 , P = .02 ) and in the Hospital Anxiety and Depression Scale anxiety score ( −1.7 ; 97.5 % CI , −2.9 to −0.6 , P = .001 ) . CONCLUSIONS : No significant long-term differences in improvement in health-related quality of life or psychological well-being was demonstrated after chronic obstructive pulmonary disease rehabilitation in a subtropical versus a temperate climate Thirty community-dwelling , moderately depressed elderly were r and omly assigned to 1 of 3 interventions : experimenter-accompanied exercise in the form of walking , a social contact control condition , and a wait-list control . Exercise and social contact both result ed in significant reductions in both the total and the psychological subscale of the Beck Depression Inventory ( BDI ) . The exercise condition , however , unlike the control conditions , result ed in decreased somatic symptoms of the BDI . These results indicate that , at least in the short term , exercise has a broader effect compared with control conditions in reducing depressive symptoms in the moderately depressed elderly Aerobic exercise has been associated with improved psychological status and physical fitness in adults , but its effects in adolescents have been less clear . This study evaluated the effects of aerobic exercise on the self-concept , depression level , and physical fitness of juvenile delinquents . Ninety-eight incarcerated youths who volunteered to participate were assigned in a blind fashion to one of two exercise programs lasting three months . Sixty-nine completed all phases of the study and are the subjects of this report . One exercise program ( 32 subjects ) emphasized aerobic exercise ; the other ( 37 subjects ) , limited exertion . Before and after participating , each subject underwent measurement of self-concept , mood , and physical fitness . While the aerobic and comparison groups were initially similar , the data demonstrated an association between participation in the aerobic exercise program and improved self-concept , mood , and fitness . Improvement in psychological variables was not dependent on improved physical fitness and was not related to preintervention measures BACKGROUND This study , conducted between 1998 and 2001 and analyzed in 2002 and 2003 , was design ed to test ( 1 ) whether exercise is an efficacious treatment for mild to moderate major depressive disorder ( MDD ) , and ( 2 ) the dose-response relation of exercise and reduction in depressive symptoms . DESIGN The study was a r and omized 2x2 factorial design , plus placebo control . SETTING / PARTICIPANTS All exercise was performed in a supervised laboratory setting with adults ( n = 80 ) aged 20 to 45 years diagnosed with mild to moderate MDD . INTERVENTION Participants were r and omized to one of four aerobic exercise treatment groups that varied total energy expenditure ( 7.0 kcal/kg/week or 17.5 kcal/kg/week ) and frequency ( 3 days/week or 5 days/week ) or to exercise placebo control ( 3 days/week flexibility exercise ) . The 17.5-kcal/kg/week dose is consistent with public health recommendations for physical activity and was termed " public health dose " ( PHD ) . The 7.0-kcal/kg/week dose was termed " low dose " ( LD ) . MAIN OUTCOME MEASURES The primary outcome was the score on the 17-item Hamilton Rating Scale for Depression ( HRSD(17 ) ) . RESULTS The main effect of energy expenditure in reducing HRSD(17 ) scores at 12 weeks was significant . Adjusted mean HRSD(17 ) scores at 12 weeks were reduced 47 % from baseline for PHD , compared with 30 % for LD and 29 % for control . There was no main effect of exercise frequency at 12 weeks . CONCLUSIONS Aerobic exercise at a dose consistent with public health recommendations is an effective treatment for MDD of mild to moderate severity . A lower dose is comparable to placebo effect Sturm J , Plöderl M , Fartacek C , Kralovec K , Neunhäuserer D , Niederseer D , Hitzl W , Niebauer J , Schiepek G , Fartacek R. Physical exercise through mountain hiking in high‐risk suicide patients . A r and omized crossover trial OBJECTIVE To assess the impact of adding exercise to dietary restriction on depressive symptoms and health-related quality of life ( HRQOL ) in women with polycystic ovary syndrome ( PCOS ) . DESIGN Analysis of depression and quality of life outcomes from a r and omized , controlled prospect i ve clinical intervention that evaluated the effects on a range of health outcomes in women with PCOS . SETTING Clinical research unit . PATIENT(S ) One hundred four overweight/obese PCOS women ( aged 29.3 ± 0.7 years ; body mass index [ BMI ] 36.1 ± 0.5 kg/m(2 ) ) . INTERVENTION(S ) R and omized to one of three 20-week lifestyle programs : diet only , diet and aerobic exercise , or diet and combined aerobic-resistance exercise . MAIN OUTCOME MEASURE(S ) Depression and PCOS-specific HRQOL . RESULT ( S ) Forty-nine women completed the intervention ( diet only = 14 , diet and aerobic exercise = 15 , diet and combined aerobic-resistance exercise = 20 ) . By week 20 all groups achieved weight loss and had improvements in depression and PCOS-specific HRQOL scores , except for body hair domain score . There was no difference between treatments for all outcomes . CONCLUSION ( S ) This study demonstrated that dietary restriction alone and combined with exercise had similar benefits for improving depression and HRQOL scores in overweight and obese women with PCOS |
1,393 | 29,870,574 | Pain scores ( reduction in visual analogue scale ( VAS ) score of at least 40 mm : 50 women ; 1 trial ; RR 25 , 95 % CI 1.56 to 400 , low- quality evidence ) and pain measured in labour ( women reporting pain relief to be " good " or " fair " within one hour of administration : 116 women ; 1 trial ; RR 1.75 , 95 % CI 1.24 to 2.47 , low- quality evidence ) were both reduced in the pethidine group , and fewer women requested any additional analgesia ( 50 women ; 1 trial ; RR 0.71 , 95 % CI 0.54 to 0.94 , low- quality evidence ) .There was limited information on adverse effects and harm to women and babies .
There were few results that clearly showed that one opioid was more effective than another .
Overall , findings indicated that parenteral opioids provided some pain relief and moderate satisfaction with analgesia in labour .
Opioid drugs were associated with maternal nausea , vomiting and drowsiness , although different opioid drugs were associated with different adverse effects .
There was no clear evidence of adverse effects of opioids on the newborn .
We did not have sufficient evidence to assess which opioid drug provided the best pain relief with the least adverse effects .
AUTHORS ' CONCLUSIONS Though most evidence is of low- or very-low quality , for healthy women with an uncomplicated pregnancy who are giving birth at 37 to 42 weeks , parenteral opioids appear to provide some relief from pain in labour but are associated with drowsiness , nausea , and vomiting in the woman .
Effects on the newborn are unclear .
Maternal satisfaction with opioid analgesia was largely unreported . | BACKGROUND Parenteral opioids ( intramuscular and intravenous drugs including patient-controlled analgesia ) are used for pain relief in labour in many countries throughout the world .
This review is an up date of a review first published in 2010 .
OBJECTIVES To assess the effectiveness , safety and acceptability to women of different types , doses and modes of administration of parenteral opioid analgesia in labour .
A second objective is to assess the effects of opioids in labour on the baby in terms of safety , condition at birth and early feeding . | Background The minimum local analgesic concentration ( MLAC ) has been defined as the median effective local analgesic concentration ( EC50 ) in a 20-ml volume for epidural analgesia in the first stage of labor . The aim of this study was to determine the relative local anesthetic sparing efficacies of intravenous and epidural fentanyl by comparison of their effects on the MLAC of bupivacaine . Methods In this double-blind , r and omized , prospect i ve study , 84 parturients at ≤ 7-cm cervical dilation who requested epidural analgesia were allocated to one of two groups . After lumbar epidural catheter placement , 20 ml bupivacaine ( n = 44 ) or bupivacaine with 3 & mgr;g/ml ( 60 & mgr;g ) fentanyl ( n = 40 ) was administered . The plain bupivacaine group then received 60 & mgr;g intravenous fentanyl . The bupivacaine – fentanyl group received intravenous saline . The concentration of bupivacaine was determined by the response of the previous patient in that group to a higher or lower concentration using up – down sequential allocation . Analgesic efficacy was assessed using 100-mm visual analog pain scores , with ≤ 10 mm within 30 min defined as effective . Results The MLAC of bupivacaine – intravenous fentanyl was 0.064 % wt/vol ( 95 % confidence interval , 0.049–0.080 ) , and the MLAC of bupivacaine – epidural fentanyl was 0.034 % wt/vol ( 95 % confidence interval , 0.017–0.050 ) . Epidural fentanyl significantly increased the analgesic potency of bupivacaine by a factor of 1.88 ( 95 % confidence interval , 1.09–3.67 ) compared with intravenous fentanyl . The epidural fentanyl group demonstrated significantly higher dermatomal spread ( P = 0.0064 ) and increased pruritus ( P = 0.01 ) . Conclusions Epidural fentanyl significantly reduced the MLAC of bupivacaine when compared with intravenous fentanyl for the parturients in this study . The significantly enhanced local anesthetic sparing , dermatomal level , and pruritus with epidural fentanyl suggest a primarily spinal site of action Purpose Epidural analgesia is associated with hyperthermia during labor and presumably causes it , although no convincing mechanism has been postulated . It seems likely that fever associated with pyrogenic factors related to labor is suppressed by opioids , whereas it is expressed normally in patients given epidural analgesia . We examined this hypothesis and the possible etiology of temperature elevation in labor . Methods In this prospect i ve , r and omized , controlled study , we assessed 201 parturients during spontaneous labor . Analgesia was r and omly provided with one of four treatment groups : ( 1 ) epidural ropivacaine alone , ( 2 ) IV remifentanil alone , ( 3 ) epidural ropivacaine plus IV remifentanil , and ( 4 ) epidural ropivacaine plus IV acetaminophen . At r and omization , patients were normothermic . Intrapartum hyperthermia ( ≥38 ° C ) was correlated to the analgesic technique . Results The maximum increase in oral temperature was greatest in the ropivacaine group ( 0.7 ± 0.6 ° C ) and least in the remifentanil group ( 0.3 ± 0.4 ° C ; P = 0.013 ) . The percentage of patients who became hyperthermic ( ≥38 ° C ) during the first 6 h of labor was greatest in the ropivacaine group ( 14 % ) and least in the remifentanil-alone group ( 2 % ) , but the difference was not statistically significant . The maximum forearm-finger gradients were lower ( less vasoconstriction ) in the remifentanil group when compared to the gradients in patients with epidural analgesia ( 1.4 ± 1.8 vs 3.0 ± 1.7 , respectively ; P < 0.001 ) . Conclusion Our results are consistent with the theory that low-dose opioids inhibit fever in patients not given epidural analgesia . However , in view of the negative results , the hypothesis of epidural-induced hyperthermia may be question able BACKGROUND The pharmacokinetics of remifentanil suggests that it may be suitable for analgesia during labour . METHODS In an open pilot study , 36 women requesting meperidine for analgesia were recruited early in labour and r and omized to receive either meperidine i.m . or remifentanil given as patient-controlled analgesia ( PCA ) . Pain severity , sedation and anxiety were assessed with visual analogue scales and overall effective analgesia was assessed by the woman and midwife . RESULTS The pain scores were lower in the remifentanil group : median pain score at 60 min was 72 mm for meperidine and 48 mm for remifentanil ( P=0.004 ) and median maximum pain score during the first 2 h was 82.5 mm for the meperidine group and 66.5 mm for the remifentanil group ( P=0.009 ) . Both the midwives ' and the women 's assessment s of overall effective analgesia were higher in the remifentanil group [ Likert scale ( 5 = excellent to 1 = poor ) : chi2=12.10 , P=0.002 for mothers ' assessment ; chi2=12.80 , P=0.002 for midwives ' assessment ] . CONCLUSION In this pilot study , remifentanil by PCA gave better pain relief to mothers in labour than intramuscular meperidine . However , remifentanil is a potent respiratory depressant and adequate continuous monitoring is necessary Meptazinol and pethidine were compared in a double-blind r and omized trial with regard to analgesia during the first stage of labour . It was concluded that neither drug is effective for sustained pain relief , and that there is no advantage of one over the other . However , neither drug affected maternal condition as reflected by respiratory rate , pulse rate and blood pressure , nor was any detrimental effect noted on the condition of the newborn infant . The critical re assessment of traditional drugs for analgesia in labour is suggested Background Pain relief during labour is a topic of major interest in the Netherl and s. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice . However its uptake by pregnant women is limited compared to other western countries , partly as a result of non-availability due to logistic problems . Remifentanil , a synthetic opioid , is very suitable for patient controlled analgesia . Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score ; however there was no difference in satisfaction with pain relief between both treatments . Methods / design The proposed study is a multicentre r and omized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia . We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia , with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia . Eligible women will be informed about the study and r and omized before active labour has started . Women will be r and omly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour . Primary outcome is the pain appreciation score , i.e. satisfaction with pain relief . Secondary outcome parameters are costs , patient satisfaction , pain scores ( pain-intensity ) , mode of delivery and maternal and neonatal side effects . The economic analysis will be performed from a short-term healthcare perspective . For both strategies the cost of perinatal care for mother and child , starting at the onset of labour and ending ten days after delivery , will be registered and compared . Discussion This study , considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia , could strongly improve the care for 180.000 women , giving birth in the Netherl and s yearly by giving them access to pain relief during labour , 24 hours a day . Trial registration numberDutch Trial Register NTR2551 , Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic . Our study was conducted to answer the question : does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population ? Method 395 healthy , nulliparous women , at term , presented in spontaneous labor with a singleton vertex presentation . These patients were r and omized to receive analgesia either , epidural with bolus doses of 1 % lidocaine or intravenous , with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters . The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded , in each patient . The total number of vacuum-assisted and cesarean deliveries were also measured . Results 197 women were r and omized to the epidural group . 198 women were r and omized to the single-dose intravenous meperidine group . There was no statistical difference in rates of vacuum-assisted delivery rate . Cesarean deliveries , as a consequence of fetal bradycardia or dystocia , did not differ significantly between the groups . Differences in the duration of the active-first and the second stages of labor were not statistically significant . The number of newborns with 1-min and 5-min Apgar scores less than 7 , did not differ significantly between both analgesia groups . Conclusion Epidural analgesia with 1 % lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate A double-blind between-patient study was carried out comparing pentazocine with pethidine in 94 women in labour . Similar analgesic and sedative effects were obtained with the two drugs , and Apgar scores were similar for babies of both drug groups . Fewer emetic sequelae were reported after pentazocine injections , though there was no statistically significant difference between the two drug groups in incidence of other side-effects The perfect analgesic regimen is constantly sought , no matter how labor is conducted . The quest for an effective drug that will afford maximum relaxation and pain relief with minimum interruption of any natural homeostatic mechanism is a foremost subject in present obstetric analgesics research . Synthetic alternatives are being offered , promising perfect compatibility with the clinician 's dem and s. Nalbuphine , a semisynthetic narcotic agonist-antagonist analgesic of the penanthren series , is supposed not to be liable to cause respiratory depression and is expected to have fewer side effects . A double-blind , r and omised prospect i ve study of 137 patients who received 10 mg nalbuphine or 50 mg pethidine i.v . during the active phase of labor in term was carried out . Maternal cardiovascular variables , pain intensity , progress of labor and fetal heart rate during labor were related to side effect and neonatal outcome ( 1- and 5-min Apgar scores and umbilical venous pH ) . Neither regimen showed an advantage over the other . Data analysis points to a possible transient depressive effect induced by nalbuphine on the fetal or neonatal central nervous system Objective . To characterize different methods of monitoring neonatal effects associated with maternal opioid analgesia . Special focus was on the static-charge-sensitive bed ( SCSB ) , which could potentially serve as a non-invasive neonatal monitor . Methods . 12 healthy , term newborns from normal pregnancies were included in this prospect i ve , r and omized , controlled study . Maternal labor analgesia was either intravenous fentanyl ( n= 5 ) or paracervical bupivacaine blockade ( n= 7 ) . Neonatal recording from delivery to the age of 12 hours included continuous SCSB monitoring with ECG and oximeter for sleep states , respiration , oxygenation , heart rate , and body movements . In addition , umbilical blood pH , Apgar , Amiel-Tison 's Neurologic and Adaptive Capacity Scoring ( NACS ) , skin cyanosis scoring , blood pressure , rectal and skin temperatures , and skin blood flow measurements were performed . Results . The study was interrupted , because one baby in the fentanyl group had a significant decrease in oxyhemoglobin saturation ( SpO2 ) to 59 % . This was considered to be residual effect of fentanyl and was treated with naloxone . SpO2 was generally lower in the fentanyl group . Epochs with SpO2 < 90 % were more frequent in the fentanyl group , especially during active sleep ( mean ± SD11.9 ± 10.7 % vs. 2.0 ± 1.7 % of epochs , p= 0.034 ) . Mean heart rate values were lower in the fentanyl group ( 121.1 ± 6.4 vs. 132.6 ± 6.8 beats per minute , p= 0.02 ) , and this difference was seen during wake and all sleep states . Maximum heart rate values were lower in the fentanyl group , too . The opiate group had less quiet sleep than controls ( 9.6 ±2.8 % vs. 18.3 ± 8.3 % , p = 0.05 ) . NACS after birth was lower in the fentanyl group ( median [ range ] 15[13–26 ] vs. 22 [ 20–25 ] , p= 0.004 ) . Conclusions . Several differences were seen between the fentanyl and the control group babies . The SCSB method proved sensitive enough to find neonatal effects of maternal analgesia . Together with ECG and SpO2 monitoring , SCSB gives plentiful information on neonatal well-being in anon-invasive way . Results of this study emphasize the importance of neonatal monitoring after maternal opiate use in labor Background : Systemic opioids are commonly administered during labor , but their efficacy has been recently question ed . In addition , laboratory and clinical studies provide a strong rationale for combining & mgr;- and & kgr;-opioid receptor agonists for analgesia . The authors therefore studied , using vali date d intensity and affective scales and definitions of effective pain relief , the efficacy of intravenous meperidine , butorphanol , and their combination for labor analgesia . Methods : Healthy women with singleton term pregnancy requesting analgesia during active labor were studied . Women were r and omly assigned to receive 50 mg meperidine , 1 mg butorphanol , or 25 mg meperidine plus 0.5 mg butorphanol ( n = 15/group ) . Pain intensity was assessed using a 0–10 numerical rating scale , and affective magnitude was assessed using a ratiometric descriptive scale before drug administration and between the sixth and seventh uterine contractions after drug administration . Results : All three treatments reduced pain intensity equally . Butorphanol alone did not reduce pain affective magnitude , whereas the other treatments did . There was a significant correlation between reduction in pain intensity and affective magnitude in all groups , with greater reductions in affective magnitude than intensity . Overall , 29 % of women exhibited clinical ly meaningful pain relief , with no difference among groups . Groups did not differ in incidence of opioid-induced adverse effects . Conclusions : These doses of meperidine and butorphanol do reduce pain intensity and affective magnitude , although a minority of patients achieve meaningful pain relief as defined in multiple patient population s , including laboring women . Combination of these drugs did not improve their therapeutic benefit BACKGROUND Epidural analgesia initiated early in labor ( when the cervix is less than 4.0 cm dilated ) has been associated with an increased risk of cesarean delivery . It is unclear , however , whether this increase in risk is due to the analgesia or is attributable to other factors . METHODS We conducted a r and omized trial of 750 nulliparous women at term who were in spontaneous labor or had spontaneous rupture of the membranes and who had a cervical dilatation of less than 4.0 cm . Women were r and omly assigned to receive intrathecal fentanyl or systemic hydromorphone at the first request for analgesia . Epidural analgesia was initiated in the intrathecal group at the second request for analgesia and in the systemic group at a cervical dilatation of 4.0 cm or greater or at the third request for analgesia . The primary outcome was the rate of cesarean delivery . RESULTS The rate of cesarean delivery was not significantly different between the groups ( 17.8 percent after intrathecal analgesia vs. 20.7 percent after systemic analgesia ; 95 percent confidence interval for the difference , -9.0 to 3.0 percentage points ; P=0.31 ) . The median time from the initiation of analgesia to complete dilatation was significantly shorter after intrathecal analgesia than after systemic analgesia ( 295 minutes vs. 385 minutes , P<0.001 ) , as was the time to vaginal delivery ( 398 minutes vs. 479 minutes , P<0.001 ) . Pain scores after the first intervention were significantly lower after intrathecal analgesia than after systemic analgesia ( 2 vs. 6 on a 0-to-10 scale , P<0.001 ) . The incidence of one-minute Apgar scores below 7 was significantly higher after systemic analgesia ( 24.0 percent vs. 16.7 percent , P=0.01 ) . CONCLUSIONS Neuraxial analgesia in early labor did not increase the rate of cesarean delivery , and it provided better analgesia and result ed in a shorter duration of labor than systemic analgesia The authors have carried out a r and om study on 75 cases in order to evaluate objective ly the therapeutic methods usually employed in cases of dystocia in starting labour . These studies have shown the superiority of Syntocinon using an infusion together with epidural analgesia . This attitude goes against the methods of treatment usually used in France . The authors explain the reasons for their choice in the light of factors that they have observed using other therapeutic methods In a double-blind , r and omized , controlled clinical trial , we compared the analgesic effect of remifentanil in patient-controlled IV analgesia ( PCIA ) during labor and delivery with the effect of an IV infusion of meperidine . Eighty-eight healthy term parturients who requested IV analgesia for labor pain were enrolled in the study and were r and omly assigned to receive either increasing doses ( 0.27–0.93 & mgr;g/kg per bolus ) of PCIA remifentanil ( n = 43 ) or an IV infusion of meperidine 150 mg ( range , 75–200 mg ) per patient ( n = 45 ) . Remifentanil by the PCIA device was more effective and reliable analgesia for labor and delivery than IV infusion of meperidine . The visual analog score was lower ( 35.8 ± 10.2 versus 58.8 ± 12.8 ; P < 0.001 ) and the patient satisfaction score higher ( 3.9 ± 0.6 versus 1.9 ± 0.4 ; P < 0.001 ) , with less of a sedative effect ( 1.2 ± 0.1 versus 2.9 ± 0.1 ; P < 0.001 ) and less hemoglobin desaturation ( 97.5 % ± 1.0 versus 94.2 % ± 1.5 ; P < 0.007 ) . The percentage of analgesia failure ( the rate of crossover from opiate to epidural analgesia ) was less for remifentanil compared with meperidine ( 10.8 % versus 38.8 % ; P < 0.007 ) . There were no significant differences between groups in the mode of delivery or neonatal outcome . There were fewer nonreassuring abnormal fetal heart rate patterns , i.e. , higher variability and reactivity with fewer decelerations , under remifentanil therapy as compared with meperidine ( P < 0.001 ) . In conclusion , an intermittent incremental regimen with repeated small-dose PCIA boluses of remifentanil provided effective and reliable analgesia during labor and delivery BACKGROUND Epidural analgesia is considered to be the preferred method of labor analgesia in preeclamptic patients . Systemic opioids are another good effective , easy to administer alternative but may cause maternal and fetal respiratory depression . Remifentanil 's rapid onset and offset of effects , should make it an ideal drug for the intermittent painful contraction during labor . Method . 30 preeclamptic patients were r and omly assigned to one of two equal groups ; Epidural Group : received epidural analgesia according to a st and ardized protocol using bupivacaine plus fentanyl . REMIFENTANIL GROUP : PCA was set up to deliver remlfentanil 0.5 microg/kg as a loading bolus infused over 20 seconds , lockout time of 5 minutes , PCA bolus of 0.25 microg/kg , continuous background infusion of 0.05 microg/kg/min , and maximum dose is 3 mg in 4 hours . Women were advised to start the PCA bolus when they feel the signs of a coming uterine contraction . RESULTS All women demonstrated a significant decrease in VAS score in the first hour after administration of analgesia ( P < 0.05 ) . Analgesic quality as regard Visual Analog Pain Scores , sedation score , and post-delivery patient satisfaction in both groups , are comparable ( P > 0.05 ) . PCA remifentanil infusion until time of delivery produce no observable maternal , fetal or neonatal side effects ( P < 0.05 ) . CONCLUSION PCA intravenous remifentanil is an effective option for pain relief with minimal maternal and neonatal side effects in labor for preeclamptic patients with contraindications to epidural analgesia or requesting opioid analgesia OBJECTIVE This study was undertaken to evaluate whether the administration of meperidine decreases the length of labor in patients with a diagnosis of dystocia during the first stage of labor . STUDY DESIGN Women with term singleton pregnancies who received a diagnosis of dystocia and required an active management of labor were r and omly assigned to receive either 100 mg of meperidine or placebo . The primary outcome measure was length of labor . RESULTS Four hundred seven pregnant women were included . There were no significant statistical differences between meperidine and placebo groups in length of labor and operative delivery rates such as forceps and cesarean section by intention-to-treat analysis . Low Apgar scores , umbilical artery acidosis , and admission to neonatal care units were increased in the meperidine group . CONCLUSION Because of the absence of any benefits in patients with dystocia in labor and the presence of harmful effects on neonatal outcomes , meperidine should not be used during labor for this specific indication This controlled , double-blind clinical trial was design ed to compare the effectiveness of meperidine alone and meperidine combined with either promethazine or propiomazine in obstetrical analgesia . A statistical method for r and omization was used to divide 520 women in labor into 3 treatment groups . Neither the patient nor the examining physician knew which of the 3 drug combinations was being given . It was found that the use of either promethazine or propiomazine in conjunction with meperidine contributed to a calmer , more comfortable labor and a more easily managed patient . No statistically significant difference was found , however , between the effects of these 2 tranquilizers . There was no evidence that either compound potentiated the analgesic effect of meperidine In a prospect i ve , double‐blind , r and omised controlled trial , we compared the efficacy of patient‐controlled analgesia using remifentanil ( 25–30 μg per bolus ) with intramuscular pethidine ( 50–75 mg ) for labour analgesia in 69 parturients . Parturients receiving patient‐controlled analgesia reported less pain than those receiving intramuscular pethidine throughout the study period ( p < 0.001 ) , with maximal reduction in visual analogue pain score at 2 h after commencement of analgesia ( mean ( SD ) 20 ( 17 ) in the patient‐controlled analgesia group and 36 ( 22 ) in the intramuscular pethidine group . The median ( 95 % CI ) time to the first request for rescue analgesics was significantly longer with patient‐controlled analgesia ( 8.0 ( 6.8–9.2 ) h ) compared with intramuscular pethidine ( 4.9 ( 3.8–5.4 ) h , p < 0.001 ) . Maternal satisfaction scores were also higher with remifentanil compared with intramuscular pethidine ( p= 0.001 ) . There was no report of sedation , aponea or oxygen desaturation in either group , and Apgar scores were similar between groups . We conclude that patient‐controlled analgesia with remifentanil provides better labour analgesia and maternal satisfaction than intramuscular pethidine . At this dose , maternal and fetal side effects were uncommon We conducted a double-blind r and omised controlled trial comparing the efficacy of analgesia during labour of remifentanil and pethidine . Nine women were r and omised to receive an i.v . bolus of remifentanil 0.5 microg.kg(-1)with a lockout period of 2 min and eight women were r and omised to receive a bolus of pethidine 10 mg with a lockout period of 5 min . A visual analogue scale ( VAS ) scoring system was used to assess the level of pain hourly throughout the first and second stages of labour and a score was recorded within half an hour of delivery for the level of pain overall throughout labour ( post delivery score ) . The study was terminated after 17 subjects , on agreement with the local ethics committee , due to concern with the poor Apgar scores in the pethidine group . With the data available , we demonstrated significantly lower mean hourly and post delivery VAS scores for pain in the remifentanil group ( P < 0.05 ) . The 1 and 5 min Apgar scores were significantly lower in the pethidine group compared with the remifentanil group ( P < 0.05 ) . This preliminary study suggests that remifentanil may have a use as patient-controlled analgesia for women in labour Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia . Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate . It can cause nausea , vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations . Neonatal effects include respiratory depression and impaired feeding . There are few large studies comparing the relative side effects and efficacy of different opioids in labour . A small trial comparing intramuscular pethidine with diamorphine , showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid . Methods The Intramuscular Diamorphine versus Intramuscular Pethidine ( IDvIP ) trial is a r and omised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother , fetus and neonate . Information about the trial will be provided to women in the antenatal period or in early labour . Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia . The sample size requirement is 406 women with data on primary outcomes . The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes . The neonatal primary outcomes are need for resuscitation and Apgar Score < 7 at 1 minute . The secondary outcomes are an additional measure of pain relief , maternal sedation , nausea and vomiting , maternal oxygen saturation , satisfaction with analgesia , whether method of analgesia would be used again , use of Entonox , umbilical arterial and venous pH , fetal heart rate , meconium staining , time from delivery to first breath , Apgar scores at 5 mins , naloxone requirement , transfer to neonatal intensive care unit , neonatal haemoglobin oxygen saturation at 30 , 60 , 90 , and 120 mins after delivery , and neonatal sedation and feeding behaviour during first 2 hours . Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour . Trial Registration IS RCT N14898678 Eudra No : 2006 - 003250 - 18 , REC Reference No : 06/Q1702/95 , MHRA Authorisation No : 1443/0001/001 - 0001 , NIHR UKCRN reference 6895 , RfPB grant PB-PG-0407 - This paper reports two r and omized control trials on the effects of nalorphine , pethidine , morphine and heroin on fetal and maternal acid base status . The drugs decreased pH and increased pCO2 in the mother , and decreased pH and base excess in the fetus . The changes in the fetus were independent of the changes in the mother . In equivalent dosages , nalorphine increased maternal pCO2 more than pethidine and morphine . The effects of heroin were found to be greater than that of other drugs , and we suggest that heroin should be avoided where the fetus is already at risk The aim of this quasi‐experimental study was to examine the effects of maternal pethidine during labour on the developing breast feeding behaviour in infants in the first 2 h after birth compared with infants not exposed to pethidine . Forty‐four healthy infants were observed immediately after birth . They were placed skin‐to‐skin on their mothers ' chests . The development of mouth and sucking movements as well as rooting behaviour and state of sleep/wakefulness were noted . The observer was blind as to the pain relief the mother had received during labour . Of the 44 mothers 18 had received pethidine . The main findings were that infants exposed to pethidine had delayed and depressed sucking and rooting behaviour . In addition , a smaller proportion of infants exposed to pethidine started to suckle the breast . Rooting movements which are expected to be vigorous at 30 min after birth were affected both by administration of pethidine and a longer second stage of labour . It is suggested that the differences found in sucking behaviour may be a central effect of pethidine . Depression of rooting movements in the pethidine group may be caused by exhaustion due to a longer second stage of labour and administration of pethidine . It is recommended that pethidine‐exposed mother‐infant couples stay together after birth long enough to enable the infant to make the choice to attach or not to attach to the nipple without the forceful helping h and of the health staff To estimate the effects of intramuscular meperidine analgesia on fetal heart rate ( FHR ) patterns compared with placebo . In a prospect i ve r and omized study , 150 healthy women with singleton term pregnancy requesting analgesia during active labor were planned to receive either intramuscular meperidin 50 mg ( meperidin group ) or normal saline ( control group ) when they requested analgesia . Fetal heart rate patterns occurring within 40 minutes of initiation of labor analgesia were retrospectively read by maternal fetal medicine specialist who was blind to type of labor analgesia . Meperidine , compared with placebo , was associated with statistically significantly less beat to beat variability ( absent or less than 5 beats per minute ) ( 28 % versus 5 % of fetuses , P<0.05 ) , lower proportion of accelerations ( 37.3 % versus 17.3 % P<0.05 ) and of the FHR . Also FHR deceleration was significantly more than control group ( 25.5 % versus 4 % , P<0.05 ) . Meperidine has deleterious effects on FHR OBJECTIVE Comparison between particular methods of obstetrics analgesia , their analgetic efects and influence on the progress of delivery and postpartum adaptation of fetus . DESIGN OF THE STUDY Prospect i ve study . SETTING The Department of Gynecology and Obstetrics of the Teaching Hospital and the 2nd Medical Faculty of the Charles University in Prague . METHODS A prospect i ve study of 92 patients who received intravenous infusion nalbuphine ( 28 women ) or epidural analgesia ( 31 women ) or pethidin ( 33 women ) . Assessment of maternal analgesia , satisaction was carried out . Apgar scores and resuscitative measures required for the neonate were note at delivery . RESULTS The best analgesic effect was in the group with using peridural analgesia , where max . score was 3 . The highest value was in the group of women who received pethidin . The most significant decrease of score after application of analgesia was in group with epidural analgesia , the least decrease of score was in the group with pethidin . The Apgar score at 1 . minute was the lowest in the group with epidural analgesia , the highest score was in the group with nalbuphine . CONCLUSION The mixed agonist/antagonist narcotic analgesic like nalbuphine have the place in clinical practice . The obstetric analgesia is very common in obstetrics practice . The epidural analgesia is very popular but not always accessible . Nalbuphine is the option which is effective in analgesia and have minimal side-effects Summary . A r and omized double‐blind study compared the effects of equi‐analgesic doses of maternally administered meptazinol ( 1.5 mg/kg ) and pethidine ( 1.5 mg/kg ) on neonatal acid‐base status . Heel‐prick sample s were taken for assessment of acid‐base status at 10 and 60 min after delivery . Maternal antenatal history , details of labour and neonatal status at delivery were also recorded . Meptazinol produced less neonatal respiratory depression than pethidine : the mean 10 min acid‐base data from 16 infants whose mothers received pethidine were indicative of a respiratory acidosis ( pH 7.13 , SD 0.08 , P co2,9.11 , SD 2.2 kPa ; st and ard bicarbonate 22.3 , SD 3.1 mmol/1 ) . This was not evident in the mean acid‐base data from 16 infants whose mothers received meptazinol ( pH 7.23 , SD 0.07 ; P co2 6.83 , SD 1.6 kPa ; st and ard bicarbonate 20.9 , SD 4.2 mmol/1 ) . The mean pH and P co2 in the two treatment groups were significantly different ( P<0.002 ) at 10 min but not at 60 min after delivery A sequential study of intravenous analgesic treatment during labour has shown that pentazocine 40 mg provides pain relief comparable to pethidine 100 mg alone or combined with levallorphan 1.25 mg ( Pethilorfan ) , but is significantly more effective than pethidine 50 mg . Pethilorfan gave less sustained analgesia and a high incidence of dysphoria . Emetic sequelae were much more frequent with either dose of pethidine than with pentazocine . Placebo treatment was easily identified by mother and observer . Its inclusion and early sequential exclusion may have had a significant effect on observer estimations of pain relief . The effect of the treatments on labour or on the condition of the infant at birth were not studied A double‐blind , r and omised study of 60 patients who received intravenous increments of nalbuphine 3 mg or pethidine 15 mg by patient‐controlled analgesia during the first stage of labour , was carried out . Pain intensity , sedation , uterine contractions , maternal cardioventilatory variables and fetal heart rate were recorded as well as any side effects . Apgar scores , time to sustained respiration and resuscitative measures required for the neonate were noted at delivery . Modified neonatal neurobehavioural studies and a retrospective assessment of maternal analgesia , satisfaction and tolerance were also carried out . Group mean values of pain scores of nalbuphine‐medicated primiparous women were statistically significantly lower than those of pethidine‐medicated patients ( p < 0.01 ) . Other assessment s did not demonstrate a statistical significance between the two groups A prospect i ve study of the effects of the i.v . injection of 75 mg meperidine , alone or combined with 25 mg promethazine , was conducted by continuous and direct monitoring of the fetus and of intrauterine pressure . The study was carried out in 16 primiparas and 24 multiparas in active spontaneous labor with cervical dilatation of 3 to 4 cm . Administration of meperidine and of meperidine with promethazine was associated with an increase in uterine activity of 31 to 45 % ( Montevideo units ) , respectively . The most marked effects were on the amplitude of the uterine contractions . There was no significant change in uterine tone . A tetanic response was recorded in two patients who vomited after the administration of meperidine with promethazine and was followed by slowing of the fetal heart rate . In no other cases were there significant changes in fetal heart rate . Except for the latter two patients , no adverse effect of meperidine or of meperidine with promethazine on the fetal heart rate was noted . The condition of the newborns at birth was excellent in all but three cases , in two of which maternal amniotic infection and high fever were present OBJECTIVE To evaluate and compare the analgesic efficacy and adverse effects of tramadol and pethidine in labor . METHOD Fifty-nine full term parturients were r and omly assigned to one of two groups in active labor . Group 1 received 100 mg pethidine ; group 2 , 100 mg tramadol , intramuscularly . Analgesic efficacy , maternal side effects , changes in the blood pressure , heart rate , and duration of labor were assessed . RESULT At 30 and 60 min after drug administration , pain relief was greater in the pethidine group than in tramadol group . The incidence of nausea and fatigue was higher in the tramadol group . Following drug administration the decrease in systolic and diastolic blood pressure and the increase in heart rate were statistically significant in both groups . No significant difference was found between the groups when compared for duration of labor and Apgar scores . None of the neonates developed respiratory depression . CONCLUSION Pethidine seems to be a better alternative than tramadol in obstetric analgesia because of its superiority in analgesic efficacy and low incidence of maternal side effects Objectives To compare the efficacy of diamorphine administered by a patient‐controlled pump ( patient‐controlled analgesia ) with intramuscular administration for pain relief in labour The aim of this prospect i ve , r and omised , blind study was to investigate the analgesic potency and tolerance of intramuscular Tramadol compared to a st and ard obstetric analgesia with Pethidine . Triflupromazine was administrated in combination with the two tested analgesics in order to study its efficacy in alleviating the emetic side effects of the tested analgesics . 66 parturients were r and omly assigned to three groups : group A : 100 mg Tramadol ( Tramal ) , group B : 100 mg Tramadol ( Tramal ) and 10 mg Triflupromazine ( Psyquil ) , group C : 50 mg Pethidine ( Alodan ) and 10 mg Triflupromazine ( Psyquil ) . No significant differences concerning duration of labour , FHR-alterations , umbilical cord blood gases , respiration pattern and Apgar Scores of the neonate occurred . In all three groups the analgesic effect was equally good . Combination of the analgesic with the antiemetic showed no reduction of the incidence and severity of side effects OBJECTIVE Our purpose was to compare the analgesic properties , effect on labor , and maternal-fetal side effects of intravenous butorphanol and fentanyl . STUDY DESIGN One hundred patients with uncomplicated term pregnancies were enrolled during early active labor . Each patient received st and ard doses of either fentanyl ( 50 to 100 micrograms ) or butorphanol ( 1 to 2 mg ) hourly on request in a double-blind manner . Pain was scored independently by the nurse and patient with a 10-point visual analog scale . Categoric and measurement data were collected for comparison of the effects on uterine activity , maternal and fetal well-being , and neonatal outcomes . RESULTS The fentanyl ( n = 50 ) and butorphanol ( n = 50 ) groups were identical with respect to maternal age , race , parity , and weight . Greater improvement in pain relief was found after the first dose of butorphanol than after fentanyl ( p < 0.05 ) . When fentanyl was given , either more doses were necessary ( 3.2 + /- 1.3 vs 2.1 + /- 1.1 , p < 0.01 ) or epidural analgesia was requested more often ( 16 % , 32 % vs 9 % , 18 % , p < 0.05 ) . Uterine contraction patterns for the first hour after dosing were unchanged , and the duration of the first and second stages of labor were not different between the two groups . No differences in maternal or newborn adverse effects were observed . CONCLUSIONS Both drugs were equally safe and without effect on active labor . Butorphanol provided better initial analgesia than fentanyl with fewer patient requests for more medication or epidural analgesia Objective To evaluate the true analgesic effect of morphine and pethidine on labour pain Preliminary observations have shown that fentanyl citrate , a potent narcotic , is helpful during labor without undue side effects . This r and omized prospect i ve investigation compared the patient-controlled administration of fentanyl with that of administration by nurses on request . Eighty healthy women beginning active labor ( cervical dilation 4 cm ) at term were assigned to receive fentanyl intravenously by either patient-controlled administration ( n=37 ) or nurse administration on dem and ( n=43 ) . Pain intensity measurements during early and late labor revealed the degree of analgesia to be the same in both groups . The delay in setting up the infusion system and the short time between requesting analgesia and vaginal delivery were limitations with self-administration . Maternal oversedation and vomiting did not occur . Neonatal naloxone therapy was used infrequently , umbilical serum levels of fentanyl were the same in both groups , and postnatal neuroadaptive testing revealed comparable results in both groups . Despite the usefulness of fentanyl during labor , administration by the patient had no advantages over administration by the nurses in significantly reducing drug use , improving pain relief , or avoiding drowsiness A single dose block r and omised double-blind study comparing intramuscular ketorolac , 50 mg of pethidine and 100 mg pethidine was carried out in multiparous women . Pain intensity and sedation effect were recorded at inclusion to the study , half hourly for the first 2 h , then hourly until 6 h after delivery . Maternal and neonatal side effects were noted including the Apgar scores and the baby 's requirements for resuscitation . All three treatments are relatively ineffective in relieving labour pain . There was no difference in the analgesic efficacy between the two doses of pethidine but both doses of pethidine were statistically more effective compared with ketorolac . There was no difference in the retrospective assessment of the three groups or when comparison was made with the previous labour . A similar number of patients required further analgesia in each group . In all three groups , no adverse effect occurred in the mother or fetus . Maternal sedation and fetal depression were statistically less in the ketorolac group . Although ketorolac had inferior analgesic effect , its use was not associated with clinical ly significant sequelae and it showed a superior safety profile compared with either dose of pethidine . The study was not powerful enough to detect a difference between 50 mg and 100 mg of pethidine Summary . The analgesic efficacy and safety of intramuscular meptazinol and pethidine in the first stage of labour were compared in a r and omized double‐blind trial in 358 patients . Pain relief was measured on a verbal rating scale , maternal side effects were recorded and neonatal outcome assessed in the first 24 h. Pain relief during the first hour after injection was significantly greater in the meptazinol than in the pethidine group at 45 and 60 min . Thereafter , there was no difference between the treatments , and the duration of action was approximately the same . Twenty‐eight per cent of patients experienced side effects after meptazinol compared with 35 % after pethidine . The commonest were nausea and vomiting with a similar incidence in both groups . Most of the neonatal observations revealed no difference between the two drugs , but significantly more babies whose mothers had received meptazinol had an Apgar score of 8 at 1 min after birth Objective It has recently been suggested that systemic pethidine is ineffective in relieving labour pain . This study aims to evaluate the analgesic efficacy of pethidine in labour A double-blind comparison of meptazinol 100 mg and pethidine 75 mg as analgesics during the first stage of labour was undertaken in 199 patients . Injections were allowed to be repeated at intervals of 2 h to a maximum of three doses . There were only minor differences between the two drugs with regard to pain relief and no differences in the need for supplementary epidural and pudendal blocks and neonatal status and behaviour . It is concluded that meptazinol and pethidine are of equal clinical value as analgesic injections during the first stage of labour Purpose : To determine the analgesic efficacy of equipotent doses of PCA ( patient-controlled analgesia ) fentanyl and PCA alfentanil for labour pain . Methods : Twenty three , ASA I – II parturients between 32–42 wk gestational age in whom epidural analgesia was contraindicated were r and omized to receive PCA fentanyl ( Group F ) or alfentanil ( Group A ) . Plain numbered vials contained 21 ml fentanyl 50 µg·ml−1 or alfentanil 500 µg·ml−1 . A one millilitre loading dose was administered . The PCA solution was prepared by diluting 10 ml study drug with 40 ml saline and the PCA pump was programmed to deliver a dose of 2 ml , delay of five minutes and a basal rate of 2 ml·hr−1 . Maternal measurements obtained were hourly drug dose , total dose , Visual Analog Pain Score ( VAPS ) q 30 min , sedation score q 1 hr and side effects . Neonates were assessed by 1,5 , and 10-min Apgar scores , umbilical venous and arterial blood gases and neurobehavioural scores at four and 24 hr . Results : Mean VAPS from 7 – 10 cm cervical dilatation were higher in Group A than in Group F. ( 85.7±13.9vs 64.6±12.1;P<0.01 ) There were no inter-group differences in VAPS from 1–3 cm , or from 4–6 cm dilatation , in maternal sedation scores or side effects , or in neonatal outcomes . Conclusion : In the doses prescribed in this study , PCA fentanyl was found to provide more effective analgesia in late first stage labour than PCA alfentanil . RésuméObjectif : Déterminer l’efficacité analgésique de doses équivalentes de fentanyl ACP ( analgésie contrôlée par le patient ) et d’alfentanil ACP pendant le travail obstétrical . Méthode : Vingt-trois parturientes , ASA I – II , de 32 à 42 sem de grossesse , réparties au hasard et pour qui l’analgésie péridurale était contre-indiquée , ont reçu du fentanyl ( groupe F ) ou de l’alfentanil ( groupe A ) ACP . Le contenu de flacons simples , numérotés , de 21 ml de fentanyl à 50 µg·ml−1 ou d’alfentanil à 500 µg·ml−1 et un millilitre de dose de charge ont été administrés . La solution d’ACP comportait 10 ml du médicament à l’étude dilués dans 40 ml de solution salée et la pompe d’ACP a été programmée pour une dose de 2 ml , un délai de cinq minutes et une vitesse de base de 2 ml·hr−1 . On a fait les mesures suivantes : la dose de médicament à chaque heure , la dose totale , le score de l’échelle visuelle analogique ( SEVA ) aux 30 min , le score de sédation aux heures et les effets secondaires . Chez les nouveau-nés on a noté l’indice d’Apgar à 1 , 5 et 10 min , les gaz du sang artériel et veineux du cordon et les scores neurologiques à 4 h et 24 h . Résultats : Les SEVA moyens pour une dilatation cervicale de 7–10 cm ont été plus élevés dans le groupe A que dans le groupe F ( 85,7±13,9vs 64,6±12,1;P<0,01 ) . Il n’y a pas eu de différence intergroupe concernant les SEVA pour une dilatation de 1–3 cm ou de 4–6 cm , les scores de sédation de la mère ou les effets secondaires , ou l’évolution des nouveau-nés . Conclusion : Selon les doses prescrites dans notre étude , le fentanyl ACP a été un analgésique plus efficace , à la fin du premier stade du travail obstétrical , que l’alfentanil ACP OBJECTIVE : To determine whether early initiation of neuraxial analgesia ( anesthetic[s ] placed around the nerves of the central nervous system ) compared with systemic opioid analgesia , followed later in labor by epidural analgesia , increases the rate of cesarean delivery in nulliparas undergoing induction of labor . METHODS : Nulliparas undergoing induction of labor who requested analgesia when cervical dilation was less than 4 cm participated in the study . Patients were r and omized to neuraxial ( early ) or systemic opioid ( late ) analgesia at the first analgesia request . Patient-controlled epidural analgesia was initiated in the early group at the second analgesia request and in the late group at cervical dilation of 4 cm or greater or at the third analgesia request . The primary outcome was the rate of cesarean delivery . RESULTS : The rate of cesarean delivery was not different between groups ( neuraxial [ early ] 32.7 % compared with systemic [ late ] 31.5 % , 95 % confidence interval of the difference -3 % to 6 % , P=.65 ) . A sample size of 30,500 would be required to detect a difference at the observed rate . There were no differences in the mode of vaginal delivery or Apgar scores . Pain scores were significantly lower ( median 1 compared with 5 on a 0–10 scale , P<.001 ) and labor duration shorter ( median 528 minutes compared with 569 minutes , P=.047 ) in the early group . The incidence of reassuring fetal heart rate tracings after analgesia was not different between groups . CONCLUSION : Early-labor neuraxial analgesia does not increase the cesarean delivery rate compared with late epidural analgesia in nulliparas undergoing induction of labor . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00380978 LEVEL OF EVIDENCE : OBJECTIVE To provide safe , satisfying obstetric analgesia when epidural analgesia was unavailable . DESIGN R and omized , controlled study of women in labor . SETTING A regional hospital offering primary - and secondary -level obstetric care . PARTICIPANTS Thirty-nine women with low-risk , single , term pregnancies and anticipated vaginal delivery . INTERVENTIONS Women in the intermittent intramuscular ( IM ) injection group received meperidine 50 - 100 mg , every 2 hours , as required . Those in the intravenous ( IV ) infusion group received an initial bolus of meperidine 25 mg , a basal infusion rate of 60 mg/h , and intermittent boluses of 25 mg/h as required . Each participant had a maximum of 200 mg of meperidine available to her during labor . MAIN OUTCOME MEASURE Pain intensity was measured on a 10-cm visual analogue scale . Pain ratings were recorded when analgesia was initiated and every 30 minutes thereafter , until delivery . RESULTS Women who received IV meperidine reported significantly lower levels of pain ( p = .0015 ) than women in the IM group . However , women in the IV group received significantly higher doses of meperidine ( mean = 121 mg ) than those in the IM group ( mean = 82 mg ; p = .0007 ) . When pain scores were compared on a smaller group of participants ( n = 18 ) who received similar doses of meperidine ( 100 - 150 mg ) , women in the IV group still reported lower pain scores ( p = .0092 ) . No significant differences were found between the groups in length of labor , maternal vital signs , fetal heart rate , Apgar scores , level of maternal sedation , or patient-reported side effects . CONCLUSION IV meperidine infusion was superior to intermittent IM injections for pain relief during labor Background Combined spinal‐epidural ( CSE ) analgesia produces rapid‐onset pain relief and allows ambulation in early labor . Epidural local anesthetics may contribute to an increase in operative deliveries by decreasing perineal sensation and causing motor weakness . Operative delivery rates might be reduced with CSE , by avoiding or delaying administration of local anesthetics . This study compares the operative delivery rates associated with a CSE technique and those associated with intravenous meperidine for labor analgesia . Methods Healthy parturients at full term were assigned r and omly to receive CSE or intravenous meperidine analgesia . The CSE group received 10 [ micro sign]g intrathecal sufentanil , followed by epidural bupivacaine and fentanyl at their next request for analgesia . Parturients receiving intravenous meperidine had 50 mg on dem and ( maximum , 200 mg in 4 h ) . Labor and delivery outcomes in both groups were recorded and compared . Results An intent‐to‐treat analysis of 1,223 women indicated that CSE does not increase the rate of cesarean delivery for dystocia in nulliparous and parous women ( CSE , 3.5 % vs. intravenous meperidine , 4 ; P = not significant ) or in nulliparous women alone ( CSE , 7 % vs. intravenous meperidine , 8 % ; P = not significant ) . Profound fetal bradycardia that necessitated emergency cesarean delivery within 1 h of the time the mother received sufentanil occurred in 8 of 400 parturients ( compared with 0 of 352 who received meperidine ; P < 0.01 ) . However , the method of fetal monitoring differed between the two groups . Despite this , neonatal outcomes were similar overall . Conclusions Combined spinal‐epidural analgesia during labor does not increase the cesarean delivery rate for dystocia in healthy parturient patients at full term , regardless of parity . However , an unexpected increase in the number of cesarean deliveries for profound fetal bradycardia after intrathecal sufentanil was observed . Further investigation is warranted Background : Pain after amputation is common but difficult to treat . Therefore , the authors examined whether postoperative treatment with gabapentin could reduce postamputation stump and phantom pain . Methods : Forty-six patients scheduled to undergo lower limb amputation were r and omly assigned to receive oral gabapentin or placebo . Treatment was started on the first postoperative day and continued for 30 days . The daily dose of gabapentin or placebo was gradually increased to 2,400 mg/day . The intensity of stump and phantom pain was recorded every day on a numeric rating scale ( 0–10 ) during the 30-day treatment period . Five interviews were performed after 7 , 14 , and 30 days and after 3 and 6 months . Results : Results from 41 patients were included in the data analysis . The risk of phantom pain ( gabapentin vs. placebo ) was 55.0 % versus 52.6 % ( risk difference , 2.4 % ; 95 % confidence interval , −28.9 to 33.7 % ; P = 0.88 ; 30 days ) and 58.8 % versus 50.0 % ( risk difference , 8.8 % ; 95 % confidence interval , −23.3 to 40.9 % ; P = 0.59 ; 6 months ) . The median intensity of phantom pain ( gabapentin vs. placebo ) was 1.5 ( range , 0–9.0 ) versus 1.2 ( range , 0–6.6 ) ( P = 0.60 ; 30 days ) and 1.0 ( range , 0–6.0 ) versus 0.5 ( range , 0–5.0 ) ( P = 0.77 ; 6 months ) . The median intensity of stump pain was 0.85 ( range , 0–8.2 ) versus 1.0 ( range , 0–5.4 ) ( P = 0.68 ; 30 days ) and 0 ( range , 0–8.0 ) versus 0 ( range , 0–5.0 ) ( P = 0.58 ; 6 months ) . Conclusion : Gabapentin administered in the first 30 postoperative days after amputation does not reduce the incidence or intensity of postamputation pain Preliminary reports about patient-controlled analgesia during labor have been promising . The purpose of this investigation was to compare our experience with meperidine given intravenously by the patient versus by a nurse . Sixtyfour healthy women beginning active labor ( cervical dilation 3 cm ) at term were r and omly assigned to either self administer a 10-mg dose as often as every 20 minutes or have a nurse administer 25 - 50 mg every 3 hours as requested . The total meperidine dose and consumption rates were greater when administered by the patient than by a nurse . Maternal side effects occurred with similar frequency in both groups , and pain relief was judged to be equivalent . Maternal and umbilical serum concentrations of meperidine at delivery increased in the patient-controlled group if active labor lasted longer than 2 hours . Neonatal naloxone therapy was used more often when meperidine was administered by the patient than by a nurse ( five of 31,16 % , versus three of 33 , 10 % , respectively ) . Self-administration of intravenous meperidine by the laboring patient was not found to be advantageous over nursing administration , and may pose an increased threat to the In a r and omised controlled trial of mothers in labour intramuscular pethidine 150 mg , repeated if necessary , was compared with self‐administered intravenous pethidine ( 0·25 mg/kg available at 10‐min‐intervals ) . Each mother agreed to have either method of pain relief and could opt for epidural block . The intramuscular group had significantly more pethidine than the intravenous group ( mean differences , primipara 29 mg ; multipara 16 mg ) . Ratings by mothers of the pain of 1st , 2nd stage and overall ( analogue scores and gradings ) were consistently better for the intravenous group although not significantly different . There were no differences in mean Apgar scores between the babies in the groups . In mothers who do not choose epidural block , similar pain relief is afforded by adequate intramuscular pethidine or self‐dem and intravenous pethidine ; however , intravenous self‐administration is more efficient since the pain relief is achieved with a lower dose of pethidine BACKGROUND To compare the analgesic efficacy of remifentanil with meperidine and fentanyl in a patient-controlled setting ( patient-controlled analgesia , PCA ) . METHODS Parturients ( n=159 ) were r and omly assigned to receive remifentanil ( n=52 ) , meperidine ( n=53 ) , or fentanyl ( n=54 ) . Pain scores and an observer sedation scores were assessed hourly . Fetal outcome was evaluated with Apgar score , cord blood gas analysis and the Neurologic and Adaptive Capacity Score . RESULTS Pain scores decreased in all groups , the decrease varying from mild to moderate , average pain scores remaining above 4.5 cm in all groups . Remifentanil PCA was associated with the greatest decrease in pain scores , but the difference was significant only at 1 h. Pain scores returned towards baseline over time ; 3 h after the initiation of treatment , pain scores no longer differed significantly from baseline values in any of the groups . Significantly more parturients receiving meperidine crossed over to epidural analgesia . Overall satisfaction scores were higher with remifentanil , but remifentanil produced more sedation and itching . More periods of desaturation ( Sa(o(2 ) ) < 95 % ) were observed during administration of remifentanil and fentanyl . There were no significant differences in fetal outcome between the three groups . CONCLUSIONS The efficacy of meperidine , fentanyl , and remifentanil PCA for labour analgesia varied from mild to moderate . Remifentanil PCA provided better analgesia than meperidine and fentanyl PCA , but only during the first hour of treatment . In all groups , pain scores returned to pre-treatment values within 3 h after the initiation of treatment The need for analgesia to overcome pain in labour is highly requested by women today . Various ways either non pharmachologic e.g. Emotional sustain , psycho-prophylactic preparation , yoga and hypnosis or pharmachologic such as epidural blockade or parenteral are used . Therefore in our study we evaluated the efficacy and tolerability of the two opioids usually used today in parenteral analgesia to reduce pain during labour : Tramadol and Meperidine . We studied two groups of patients each made up of 20 women in labour , all at term and with a physiologic course of pregnancy . 75 mg i.m . of Meperidine chloryhydrate were somministered in the first group while in the second group 100 mg i.m . of tramadol chloryhydrate were somministered . Various maternal , fetal and neonatal parameters were then monitored demonstrating -- A moderate maternal analgesic effect in both drugs ( evaluated through the analogic grading of pain ) . In the group to whom Meperidine was given , sedative effects on the mother were observed associated with respiratory depression in the newborn ( the latter evaluated through the Apgar index at 1st and 5th minute of life and pH of the blood obtained at the umbilical cord . The data obtained permitted us to conclude that Tramadol in accordance to the obtained in literature gives an analogous analgesic effect , with better tolerability for the absence of collateral effects on the mother , fetus and newborn A number of recent studies have suggested that the analgesic effects of highly lipid-soluble opioids are similar when these agents are administered either epidurally or intravenously . We sought to test whether the lipid-soluble opioid sufentanil was more effective when administered intrathecally than when administered epidurally or intravenously . Twenty-four women during active labor received sufentanil 10 micrograms either intrathecally ( n = 9 ) , epidurally ( n = 8) , or intravenously ( n = 7 ) , using a combined spinal-epidural technique . The sufentanil was administered alone , without concomitant local anesthetics . Analgesia was assessed using the visual analogue score as well as the time elapsed from the administration of study drug to the patient 's request for additional analgesia via the epidural catheter ( bupivacaine 0.25 % ) . The median duration of analgesia ( median , interquartile range ) was 84 ( 70 - 92 ) min in the intrathecal group , 30 ( 23 - 32 ) min in the epidural group , and 34 ( 17 - 30 ) min in the intravenous group ( P < 0.001 ) . The intrathecal group showed rapid and significant decrease in visual analogue scale scores , whereas visual analogue scale scores in the other two groups did not decrease and remained significantly elevated compared to those of the intrathecal group at all observation points . Side effects were limited to pruritus in 3 patients ( 2 moderate and 1 severe ) in the intrathecal group . No patient developed post-dural puncture headache . We conclude that sufentanil 10 micrograms intrathecally provides rapid and effective analgesia of 1 - 2-h duration during labor . Epidural and intravenous use of this dose of sufentanil did not provide evidence of satisfactory analgesia . ( ABSTRACT TRUNCATED AT 250 WORDS The analgesic affects of TNS , pethidine and placebos on labour pain were studied in 30 parturient women during the first stage of labour . 10 had TNS paravertebrally in the region of the afferent nerves at Th 10-Th 12 ; one group of 5 had unspecific ( wrong ) TNS ; in another group of five no current was applied ( placebo ) ; five women were given 50 mg of pethidine intravenously ; five patients acted as a control group . To assess the analgesic effects the women were asked to estimate the intensity of pain ( grade s 1 - 6 ) over a period of 70 minutes . There was no significant difference between the placebo , unspecific TNS and control groups as regarded the increase in pain during the test period . Patients who had received pethidine and those who had been given TNS at the site of the afferent nerves transmitting impulses from the uterus experienced considerable relief of pain . The differences were highly significant . The observations prove the genuine analgesic action of TNS . The use of this technique in obstetrics is discussed Objective To examine the effects of meperidine and nalbuphine on intrapartum fetal heart rate ( FHR ) tracings using computer analysis . Methods We studied 28 women with uncomplicated pregnancies in early labor at term with reactive FHR tracings . The women were r and omized to receive either meperidine 50 mg or nalbuphine 10 mg intravenously on request . One-hour FHR recordings were obtained before and immediately after administration of the medications . Results There were no significant differences in the FHR characteristics of the two groups during the pre-treatment period . Nalbuphine significantly decreased the number of accelerations of 10 beats per minute ( 17 versus 4 , P = .003 ) and 15 beats per minute ( 10 versus 1.5 , P = .001 ) , time spent in episodes of high variation ( 35.5 versus 10 minutes , P = .004 ) , long-term variation ( 47 versus 29.8 milliseconds , P = .002 ) , and short-term variation ( 8.4 versus 6.4 milliseconds , P = .03 ) . Meperidine had no significant effect on any FHR characteristic . Conclusion In the early intrapartum period of normal term pregnancies and at commonly used dosages , nalbuphine had a significant effect on FHR tracings , whereas meperidine had no effect , as determined by computer analysis The perinatal effects of phenoperidine and of epidural anaesthesia were studied in a r and omised trial in which only normal patients were studied . Foetal heart rate curves , pH , pCO2 and neonatal clinical behaviour demonstrated that both kinds of analgesia had no harmful effects BACKGROUND Although epidural anaesthesia has become a st and ard method for labour analgesia all over the world , it is far from being ideal because of side effects and contraindications . Many alternative techniques have therefore been proposed , including the continuous infusion of remifentanil . Encouraged by positive reports , we compared the efficacy of patient-controlled remifentanil infusion ( PCA ) with patient-controlled continuous epidural analgesia ( PCEA ) . METHODS Fifty-two ASA I and II parturients were arbitrarily allocated , without r and omisation , to two groups to receive PCEA with 0.125 % bupivacaine and 0.2 microg kg(-1 ) fentanyl ( basic infusion 1 mL h(-1 ) , bolus 4 mL , lock-out time 15 min ) or remifentanil PCA ( 0.2 microg kg(-1 ) bolus doses , without basic infusion , lock-out time 2 min ) . The intensity of pain was assessed using the VAS scale every 15 min in the PCEA group and every 10 min in the PCA group . RESULTS During the first two hours of labour , the VAS score was significantly lower in the PCEA group . Later there was no difference between the groups . The clinical status of the newborns was similar . CONCLUSION The results are difficult to interpret since there was no r and omisation and parturients participated in decisions about allocation to one of the study groups . Analgesia provided by remifentanil was assessed as highly acceptable by the patients and the drug can be regarded as a safe alternative to epidural analgesia during labour Ninety primigravide were r and omly allocated into three groups at the beginning of active phase of labor . Dihydroetorphine hydrochloride ( DHE ) was administered to group A ( n = 30 ) , tramadol to group B ( n = 30 ) , and group C ( n = 30 ) was a blank control . Various parameters about analgesia effects , progress of labour and fetal and neonatal well-being were investigated and also umbilical artery and vein blood gases analyzing were carried out in all cases . As a result , the effective rate of pain relief in group A was 67 % and in group B 63 % ( P > 0.05 ) . The average time of onset of action in DHE group was 16.5 + /- 2.9 minutes which was significantly shorter than 26.1 + /- 5.4 minutes in tramadol group ( P = 0.0001 ) . There were higher rate ( 36.7 % ) of operative intervention ( forceps and vaginally or cesarean section ) and a higher average amount of postpartum hemorrhage in group A , as compared with the control group , but no significant difference was shown between group B and group C. No difference was found in other parameters ( among the three groups duration of labour , Apgar scores of neonates , cord blood gases , etc . ) . The conclusion is that , both DHE and tramadol may have a good effect of pain relief in labour . The time of onset of action in DHE group is significantly shorter than that in tramadol group . Neither analgesics cause circulation and respiratory depression in the mother and neonates , but DHE may have influence on uterine contraction . To achieve an excellent pain relief by higher dosage of DHE and tramadol need further r and omized investigation Background : We compared the efficacy and side‐effects of remifentanil with those of nitrous oxide during the first stage of labour Because tramadol does not exhibit an depressive effect on ventilatory activity it is often be used in the obstetrical analgesia , at most in form of an intramuscularly injection . In a prospect i ve study on at all 49 women under labour the clinical effect of the noninvasive rectal application of Tramadol , Pethidin , and Denaverin has been compared . The first dosage was 100 mg of all substances . Around the half of the women said that analgetic effect was good or very good . On only every fifth it was sufficient or not enough . The effect was at near the same in all treatment groups . Because of a low incidence of maternal side effects , the absence of side effects on the newborn , and near the same results on the analgetic effect of parenteral application in other studies , tramadol suppositories can be recommended for obstetrical analgesia Objective To compare the pain relief and side effects of intramuscular pethidine with intramuscular diamorphine in labour Ketorolac is a potent analgesic agent with antiplatelet properties which is known to cross the placenta . The aim of this study was to determine whether maternal administration of ketorolac in labour had any effect on neonatal platelet function as compared with maternal administration of pethidine and prochlorperazine . Eighteen parous women were studied in labour , twelve received pethidine ( control ) and six received ketorolac for analgesia . Immediately after delivery , blood was taken from the umbilical vein and anticoagulated with citrate . Platelet aggregation in whole blood was studied . Ketorolac significantly inhibited aggregation in response to arachidonic acid and collagen but not ADP . These findings confirm that ketorolac crosses the placenta . The antiplatelet effects are likely to be related to ketorolac 's inhibitory effect on TxA2 production which is required for arachidonic acid and collagen-induced aggregation , but not the primary aggregation response induced by ADP . These effects suggest that ketorolac should be used with caution in patients whose neonates are at risk of haemostatic problems This r and omized investigation compared the efficacy of the conventional narcotic , meperidine , and a more potent and short-acting analgesic , fentanyl , during labor . One hundred five women with uncomplicated term pregnancies in active labor were r and omly assigned to receive either intravenous fentanyl ( 50–100 μg every hour ) or meperidine ( 25–50 mg every 2–3 hours ) in a non-blinded manner . The analgesics were rated equivalent in efficacy . Maternal nausea , vomiting , and prolonged sedation occurred more frequently in the meperidine group . Naloxone use was significantly less in fentanyl-than in meperidine-exposed infants ( one of 49 versus seven of 56 ; P < .05 ) . Neuroadaptive testing at approximately 2 hours and 24 hours postnatally revealed similar averaged scores in the two groups . Using the described intravenous dosing schedule , fentanyl was preferable to meperidine during labor because there was no prolonged maternal sedation or vomiting necessitating therapy and the requirement for neonatal naloxone was reduced OBJECTIVE To evaluate the association between the use of pethidine during the first stage of labor and the presence , type and timing of acidosis in the newborn at birth . STUDY DESIGN Secondary data analysis of a r and omized controlled trial , which included term singleton pregnancies diagnosed with dystocia and requiring active management of labor . Women were r and omized to receive either 100 mg of pethidine or placebo . Statistical analyses were performed using chi(2 ) or Fisher 's exact tests for proportions and multiple linear regression for continuous outcomes . RESULTS Three hundred and eighty-three pregnant women with a valid arterial blood cord sample were included in the final analysis . Lower pH and bicarbonate levels , as well as higher pCO(2 ) levels were found in the pethidide group . A higher incidence of acidosis was found in the pethidine group ( pH<7.12 OR : 8.59 95 % C.I. 3.29 , 22.46 ) . The highest frequency of acidosis was encountered when pethidine-delivery interval was 5 h. CONCLUSION Pethidine use during the first stage of labor was associated with an increased risk of acidosis at birth Summary Thirty two women who were participating in an efficacy study comparing 10 mg ketorolac with 50 mg or 100 mg of pethidine in the relief of labour pain , underwent sampling of vein blood , for determination of plasma ketorolac concentrations . The sample was withdrawn at delivery and a sample of umbilical cord blood was withdrawn at the same time . The ratio of ketorolac concentrations in the cord blood sample : the maternal venous sample were calculated and plotted against the time elapsed between drug administration and sampling . Sample s for one patient , withdrawn 24 min after dosing , had ketorolac concentrations below the quantification limit . The ratios in the remaining patients were all low and showed a tendency to increase with time . The mean ratio was 0.116 with a range of 0.04 in 2 patients , at 43 min and 1 h 6 min , to 0.25 at 6 h 34 min Forty-two women at term received pethidine 100 mg and 43 received pentazocine 45 mg , both given in a double-blind r and omized manner . There was no difference in analgesic effect between the groups , but twelve patients were judged to need more than one injection of pentazocine , compared with seven in the pethidine group . The Apgar scores at 1 and 5 min were significantly less in the pethidine group . Four neonates in the pethidine group and two in the pentazocine group were severely depressed and received naloxone between 5 and 15 min after birth . The remainder of the infants received naloxone 200 microgram i.m . 15 min after birth . From 5 min after birth , end-expiratory carbon dioxide concentrations and from 15 min transcutaneous PO2 were recorded . A significantly smaller end-tidal carbon dioxide concentration was measured when more than one injection of pentazocine had been given . Repeated doses of pethidine , on the other h and , result ed in a greater end-tidal carbon dioxide concentration . Vigorous ventilation was even more pronounced when naloxone was given indicating an analeptic effect when two drugs with antagonistic activity are combined . At no time was transcutaneous PO2 less than 6.1 kPa . We conclude that both pethidine and pentazocine produce adequate pain relief during labour , but more than one injection of pethidine is associated with greater neonatal depression Abstract Anileridine , a relative newcomer to the field of obstetric analgesia , was compared with meperidine in a double blind study involving four treatment groups . These treatment groups were as nearly alike in size and make-up as it is possible to obtain with a r and om sampling of patients . Four hundred seventy-one women were given a primary injection of either 75 mg . meperidine ( Group 1 ) , 30 mg . anileridine ( Group 2 ) , 75 mg . meperidine with 5 mg . perphenazine ( Group 3 ) , or 30 mg . anileridine with 5 mg . perphenazine ( Group 4 ) . All four of the treatment groups received 0.4 mg . of atropine sulfate and 0.5 mg . levallorphan tartrate . The state of anxiety of each woman was noted on admission and an evaluation of combined sedative-analgesic effect was made following the primary injection of medication . The patient 's behavior in the postmedication period was noted , and the infants were rated by Apgar scores at 1 and 5 minutes after delivery . The analgesics produced almost exactly comparable effects , with 30 mg . anileridine apparently being equivalent to 75 mg . meperidine . When a phenothiazine derivative was added to either analgesic , an increase in the optimum response was obtained among the apprehensive patients but not in the calm patient . This increase was not statistically significant . Apgar ratings were essentially the same in all four treatment groups and indicated that anileridine , in equivalent dosage , had no more depressant effect on the fetus than meperidine whether or not these drugs were combined with the phenothiazine derivative . No significant side effects were noted following the use of either analgesic agent cancer , the ratio of etiocholanolone to 17-hydroxysteroids in urine ( Bulbrook et al. , 1960 ) , could be a non-specific effect of illness . Further , Russfield 's ( 1960 ) study of the trophic hormone content of pituitary gl and s at necropsy did not reveal any difference between the pituitaries obtained from individuals who died from malignant disease and those who died from other causes . It is apparent that further investigation of the relation between pituitary gonadotrophin content , urinary excretion , and , if possible , circulating hormone is required before any final conclusion can be reached concerning the basic significance of the present results . Although low levels of urinary gonadotrophins were , in general , associated with a poor prognosis in this series , their ultimate value as an empirical guide to prognosis after ablative endocrine procedures in women with carcinoma of the breast can be assessed only by prospect i ve studies .. Such a study is at present in progress in this department Morphine derivatives are the most frequently used analgetic substances in obstetrics today . Nevertheless , nausea , vomiting , weariness , and somnolence are common side effects of these drugs . Moreover opiates exhibit a depressive effect on ventilatory activity . As many studies have demonstrated tramadol , a new analgetic substance amongst the opiates does not show a depressive effect to such a high degree . In this prospect i ve r and omized trial we compared the efficacy as well as the safety of 100 mg tramadol and 100 mg pethidine in 40 women asking for pain relief during labour . The duration of labour was slightly but not statistical significantly shorter in the pethidine group . An analgetic effect could be observed in the pethidine as well as the tramadol group by both the pregnant women and the attending physician about 10 min after application lasting for about 2 hours . Concerning the side effects tramadol highly contrasted with pethidine . There were less cases of weariness and somnolence and the ventilatory frequency of the newborn babies tended to be higher than in the pethidine group . The serum levels of tramadol in umbilical and maternal veins demonstrated values of 0.83 + /- 0.15 ( mean + /- SEM ; quotient ) . The results of this study seem to establish an analgetic effect of tramadol similar to pethidine but with less side effects A double‐blind , between‐patient comparison of intramuscular pethidine 100 mg and nalbuphine 20 mg for the relief of pain during labour in 80 patients is described . Severity of pain was assessed before and after treatment by subjective pain scores and visual analogue scales . Neither of these methods showed a significant difference between the treatments . Nalbuphine was associated with less maternal nausea and vomiting than pethidine , but this possible advantage was somewhat offset by a tendency of the drug to produce more maternal sedation and dizziness . The mean umbilical vein/maternal vein ratio was significantly higher for nalbuphine ( 0.78 . SEM 0.03 ) than for pethidine ( 0.61 , SEM 0.02 ) . which suggests easier placental transfer of the former . This finding was reflected in significantly lower 2–4 hour neurobehavioural scores for the infants of mothers given nalbuphine , but there was no significant difference between these scores at 24 hours . On the basis of this study , nalbuphine does not offer a substantial improvement over pethidine for pain relief in labour The analgesic efficacy and safety of tramadol 50 mg , 100 mg and pethidine 75 mg , administered intramuscularly were compared in a r and omized , double-blind clinical trial in 90 pregnant women with labour pain . Pain relief was measured by a 4-point verbal rating scale 10 , 20 , 30 , 45 and 60 min after the administration of study drugs . The average total pain relief score within the first hour was 0.9 with tramadol 50 mg , 1.7 with tramadol 100 mg and 1.7 with pethidine 75 mg . In comparison to both tramadol doses the administration of pethidine was associated with a significantly higher frequency of adverse events and a significantly lower respiratory rate in the neonates . The results indicate that tramadol 100 mg is as effective as pethidine 75 mg but has a superior safety profile Purpose A pilot study was undertaken to compare the efficacy of two regimens of intravenous patient-controlled analgesia ( PCA ) with remifentanil for labour analgesia . Methods Twenty term parturients requesting labour analgesia were r and omized to receive one of two regimens of intravenous remifentanil . The initial setting s in both groups consisted of an infusion of 0.025 μg·kg-1·min-1 , a PCA bolus of 0.25 μg·kg-1 and a lockout interval of two minutes . In Group A , the infusion was increased in a stepwise manner from 0.025 to 0.05 , 0.075 and 0.1 μg·kg-1·min-1 as required ; the bolus was kept constant at 0.25 μg·kg-1 . In Group B , the bolus was increased from 0.25 to 0.5 , 0.75 and 1 μg·kg-1 as necessary ; the infusion was kept constant at 0.025 μg·kg-1·min-1 . Maternal pain , satisfaction and sedation scores , remifentanil requirement , and side effects were recorded . Results Mean pain and patient satisfaction scores , and cumulative doses of remifentanil were similar in the two groups . The overall incidence of side effects was greater in Group B ( P = 0.0007 ) , with drowsiness observed in 100 % of patients , as compared to 30 % in Group A ( P = 0.003 ) . The minimum oxygen saturation levels were 94.3 % ± 2.6 % and 92.2 % ± 3.8 % in Groups A and B respectively ( P = 0.19 ) . Conclusions Although pain and satisfaction scores were similar in both groups , the regimen used in Group A was associated with fewer side effects compared to the Group B dosing regimen . This pilot study suggests that remifentanil intravenous PCA is efficacious for labour analgesia as a bolus of 0.25 μg·kg-1 , with a lockout interval of two minutes and continuous infusion of 0.025 - 0.1 μg·kg-1·min-1 . The potential for respiratory depression m and ates close respiratory monitoring . Large-scale trials to evaluate safety issues are warranted . RésuméObjectifUne étude pilote a été entreprise afin de comparer l’efficacité de deux régimes intraveineux d’analgésie contrôlée par le patient ( ACP ) avec du rémifentanil pour le travail obstétrical . MéthodeVingt parturientes à terme dem and ant une analgésie pour le travail ont été r and omisées à recevoir l’un de deux régimes de rémifentanil intraveineux . Les réglages de base dans les deux groupes consistaient en une perfusion de 0,025 μg·kg-1 · min-1 , un bolus ACP de 0,25 μg·kg-1 et un intervalle d’interdiction de deux minutes . Dans le groupe A , la perfusion a été augmentée par paliers de 0,025 à 0,05 , 0,075 et 0,1 μg·kg-1 · min-1 au besoin ; le bolus a été maintenu constant à 0,25 μg·k-1 . Dans le groupe B , le bolus a été augmenté de 0,25 à 0,5 , 0,75 et 1 μg·kg-1 au besoin ; la perfusion a été maintenue constante à 0,025 μg·kg-1·min-1 . Les douleurs maternelles , les scores de satisfaction et de sédation , les besoins en rémifentanil et les effets secondaires ont été enregistrés . RésultatLes scores moyens de douleur et de satisfaction des patientes ainsi que les doses cumulatives de rémifentanil ont atteint des résultats similaires dans les deux groupes . L’incidence totale d’effets secondaires était plus élevée dans le groupe B(P = 0,007 ) , avec des cas de somnolence chez 100 % des patientes comparativement à 30 % dans le groupe A ( P = 0,003 ) . Le minimum de saturation en oxygène était de 94,3 % ± 2,6 % et 92,2 % ± 3,8 % dans les groupes A et B respectivement ( P = 0,19 ) . Conclusion Bien que les scores de douleur et de satisfaction étaient similaires dans les deux groupes , le régime utilisé par le groupe A a été associé à moins d’effets secondaires que le régime de dosage du groupe B. Cette étude pilote suggère que l’ACP intraveineuse au rémifentanil est efficace pour l’analgésie pour le travail en bolus de 0,25 μg·kg-1 , avec un intervalle d’interdiction de deux minutes et une perfusion continue de 0,025 - 0,1 μg·kg-1 · min-1 . Toutefois , un monitorage respiratoire attentif est nécessaire en raison du potentiel de développement de dépressions respiratoires . Des essais à gr and e échelle pour évaluer les questions d’innocuité sont requis Fentanyl citrate is a potent short-acting narcotic reported to cause less nausea and sedation than morphine or meperidine hydrochloride . The purpose of this prospect i ve investigation was to determine whether a safe but adequate intrapartum dosing schedule is possible . A total of 137 women with uncomplicated term pregnancies were offered a st and ard intravenous dose ( 50 mcg or 100 mcg hourly as needed ) of fentanyl citrate during active labor . Temporary analgesia and mild sedation were apparent in each case . The cumulative dose varied in accordance with maternal needs ( mean , 140 + /- 42 micrograms ; range , 50 mcg to 600 micrograms ) . Apart from a brief decrease in fetal heart rate variability that lasted 30 minutes , no worrisome pattern was apparent from exposure to fentanyl citrate . Pediatric examinations were performed without knowledge of analgesic therapy on infants exposed to fentanyl citrate and those not exposed to analgesics . No differences were found in frequencies of newborn depressed respirations , low Apgar scores , or neurologic and adaptive capabilities at two hours and 24 hours postnatally . With the use of the described dosing schedule , fentanyl citrate was helpful during labor and did not cause immediate or prolonged hazards to the mother and unborn infant Summary . A double‐blind comparison of pethidine and meptazinol in the relief of pain during labour was undertaken in 205 healthy women . The protocol allowed 100 mg of the test drug to be repeated at intervals of 2 h to a maximum of three doses . It was noteworthy that only 29 mothers were given a second dose of narcotic . Every woman receiving one injection of meptazinol complained of moderate to severe pain after 2 h ; 97 % of those receiving one injection of pethidine were complaining of moderate to severe pain after 2 h. There was no difference between the two drugs with regard to pain relief or in side‐effects both in mother and baby We have previously demonstrated that continuous epidural infusions of fentanyl without local anesthetics elicit analgesia by a systemic mechanism . In this study , we examined the hypothesis that , in the presence of epidural bupivacaine , continuous infusions of epidural fentanyl elicit analgesia by a spinal mechanism . Forty-eight nulliparous women in active labor participated in this prospect i ve , r and omized , double-blinded study . Women received lumbar epidural analgesia with 20–30 mL bupivacaine 0.125 % until pain free . Subjects were then r and omized to either IV or epidural ( EPI ) fentanyl infusion groups . Each infusion delivered fentanyl 30 & mgr;g/h . All women received an epidural infusion of bupivacaine at a rate of 20 mL/h , the concentration of which was determined by the response of the previous woman in the same group to the analgesic regimen used . Unlike previous studies that assessed the minimum local analgesic concentration ( MLAC ) for bolus administration at the initiation of analgesia , this study assessed MLACinfusion for the maintenance of analgesia throughout the first stage of labor . MLACinfusion was determined using the up-down sequential analysis described by Dixon and Massey . The MLACinfusion of epidural bupivacaine was 0.063 % ( 95 % confidence interval , 0.058–0.068 ) and 0.019 % ( 95 % confidence interval , 0.000–0.038 ) in the IV and EPI groups respectively . A continuous infusion of fentanyl was more than three times as potent when administered by the epidural than by the IV route . This marked increase in potency for the epidural route is highly suggestive for a predominantly spinal mechanism of action for infused epidural fentanyl under the conditions of this study A r and omised double‐blind comparison of pethidine and meptazinol used as analgesics in labour was carried out in 1100 consecutive women who would normally have received intramuscular pethidine . Pain assessment s at 30‐minute intervals were made independently by patients and midwives . Maternal and neonatal side effects were noted . The babies ' requirements for resuscitation and weight changes in the first 5 days were studied . There was no difference in the analgesia provided by the two drugs ; the pattern of side effects was similar , but the incidence of vomiting was greater following meptazinol administration . The babies in the two groups were similar with respect to resuscitation received , weight gains or losses and the incidence of clinical neonatal jaundice . The most striking findings were the poor quality of pain relief experienced by both groups following parenteral analgesics and the high incidence of side effects Summary Butorphanol tartrate 1 mg and 2 mg were compared in 80 normal mothers at term in a doubleblind study with meperidine hydrochloride 40 mg and 80 mg for the relief of pain in labour . Butorphanol was found to be as effective as meperidine in relieving pain in labour . The foetal condition , as measured by ECG monitoring , Apgar scores , time to sustained respiration , umbilical venous H+ ( pH ) and Pco2 , and a general nursery survey were comparable for meperidine and butorphanol . No psychomimetic phenomena were seen . Assays indicated that both butorphanol and meperidine crossed the placenta . The mean concentration of butorphanol in neonatal serum was 0.84 times maternal serum at 1.5 to 3.5 hours after intramuscular administration of a single or two successive doses of butorphanol 1 mg or 2 mg to the mother . The mean concentrations for meperidine in neonatal serum was 0.89 times maternal serum at 0.85 to 3.6 hours after intramuscular administration of meperidine 40 mg or 80 mg to the mother . Neither analgesic caused severe depression of the infant except for one meperidine-treated case . RésuméLes tartrate de butorphanol , à des doses de 1 et de 2 mg , a été comparé à la mépéridine ( doses de 40 et de 80 mg ) pour soulager les douleurs du travail dans un groupe de 80 parturientes en bonne santé , ceci dans le cadre ďune étude à double insu . Le butorphanol s’est avéré aussi efficace que la mépéridine pour soulager les douleurs du travail . Ľévaluation des bébés ( monitoring de ľECG foetal , Apgar , début de la respiration régulière , pH et Pco2 du sang veineux du cordon et , enfin , évaluation générale en pouponnière ) était comparable avec ľun et ľautre des agents . On n’a pas observé de phénomènes psycho-mimétiques . Les analyses ont objectivé le passage transplacentaire des deux produits . La concentration sérique du nouveau-né en butorphanol était de 0.84 par rapport à celle de la mère , une heure et demie à trois heures et demie après ľadministration à la mère ďune dose unique ou de deux doses successives de l à 2 mg , par voie intramusculaire . La concentration sérique retrouvée chez le nouveau-né , après administration de mépéridine , était de 0.89 par rapport à celle de la mère . Dans toute cette étude , nous n’avons observé une dépression respiratoire que chez un seul enfant ( do nt la mère avait reçu de la mépéridine ) Purpose To examine dose and lockout intervals for effective fentanyl patient-controlled analgesia ( PCA ) in second trimester genetic termination of pregnancy , and compare three different fentanyl PCA regimes with morphine PCA . Methods In a double-blind r and omized study 60 ASA physical status 1–11 patients received one of three fentanyl PCAs or morphine PCA . Labour was induced with prostagl and ins and PCA use continued until delivery . Within two hours following delivery , four visual analogue scales ( VAS ) were administered measuring anticipated pain , pain relief in labour and delivery , and overall satisfaction . The drug delivery/dem and ratio for two hours preceding delivery was obtained from the PCA pump . The outcome variables were analyzed using the Chi square test and analysis of variance as appropriate . Results The delivery/dem and ratio was 0.71 ± 0.27 ( mean ± st and ard deviation ) for morphine ; 0.67 ± 0.21 for fentanyl 50 μg , lockout six-minute ; 0.63 ± 0.21 for fentanyl 25μg , lockout three-minute ; and 0.81 ±0.17 for fentanyl 50 μg , lockout three-minute groups . We found no significant differences among the four groups with respect to using delivery/dem and ratio as a measure of pain relief . Morphine had the highest rate of side effects compared to fentanyl . There was strong evidence of differences among groups with regard to patient satisfaction and expected pain , and moderate evidence of differences in the delivery and labour pain scores . Conclusion This study found PCA fentanyl 50 μg with a lockout period of six minutes provided satisfactory analgesia for second trimester labour . RésuméObjectifDéterminer la dose et les périodes réfractares d’une analgésie auto-contrôlée ( AAC ) efficace utilisée en cas d’interruption de grossesse génétique , et comparer trois régimes d’AAC avec fentanyl à la morphine en AAC.MéthodePendant l’étude r and omisée et à double insu , 60 patientes d’état physique ASA I-II ont reçu l’un des trois régimes de fentanyl en AAC ou de la morphine en AAC . Le travail a été induit avec des prostagl and ines et l’AAC continue a été utilisée jusqu’à l’accouchement . Pendant les deux premières heures après l’accouchement , la douleur attendue , le soulagement de la douleur du travail et de l’accouchement et la satisfaction générale ont été évalués grâce à quatre échelles visuelles analogiques ( EVA ) . Pendant les deux heures précédant l’accouchement , le ratio offre/dem and e de médicaments a été révélé par les données de la pompe à AAC . Les variables des résultats ont été analysées par le test du Khi carré et l’analyse de la variance selon les besoins . RésultatsLe ratio offre/dem and e de morphine a été de 0,71 ±0,27 ( moyenne ± écart type ) ; de 0,67 ± 0,21 pour la dose de 50 μg de fentanyl et une période réfractare de six minutes ; de 0,63 ± 0,21 pour 25 μg de fentanyl et trois minutes réfractares et de 0,81 ±0,17 pour 50 μg de fentanyl et trois minutes réfractares . Ce n’est donc pas une mesure idéale de résultat . La morphine , comparée au fentanyl , avait le taux le plus élevé d’effets secondaires . Une forte évidence de différence intergroupe a été notée quant à la satisfaction des patientes et à la douleur prévue , et une évidence modérée de différences de scores de douleur pendant le travail et l’accouchement . Conclusion Létude montre que 50 μg de fentanyl et une période réfractare de six minutes offrent une analgésie satisfaisante pendant le travail du second trimestre Various drugs , including sulphafurazole ( sulfisoxazole ) ( Silverman et al. , 1956 ) , vitamin K in excess ( Meyer and Angus , 1956 ) , and novobiocin ( Sutherl and and Keller , 1961 ) , have sometimes caused neonatal jaundice . In older patients jaundice of obstructive type is known to have result ed from the use of certain tranquillizers . The phenothiazines ( Werther and Korelitz , 1957 ; Kemp , 1957 ) and trifluoperazine ( Kohn and Myerson , 1961 ) are examples of this ; but in the case of ectylurea an increased bilirubin was reported which was mostly unconjugated ( Hochman and Robbins , 1958 ) . During labour many patients suffer extreme discomfort from uterine contractions ; they become anxious about the outcome and are unable to relax . Such patients need analgesic and calming drugs . These must be safe for both mother and foetus , and be rapidly effective . Morphine and pethidine are wellestablished analgesics , but some patients require a tranquillizing drug as well . The combinations in use in the maternity unit of our hospital at the time of the trial were morphine with chlorpromazine and pethidine with promazine . It was decided to carry out a controlled trial to see if any of these drugs produced adverse effects on the serum bifirubin of babies born to mothers in the unit , and four combinations were used : group 1 , pethidine 100 mg . , promazine 50 mg . ; group 2 , pethidine 100 mg . , promazine 25 mg . ; group 3 , pethidine 100 mg . ; and group 4 , morphine 15 mg . , chlorpromazine 12.5 mg . A further group ( group 5 ) received no drugs and served as a control . It was decided to study the babies of 15 patients in each group . The allocation of women to a group was r and om , but , once begun , the same drugs were used throughout labour in each case . Patients excluded from the trial were those who underwent caesarean section , if they suffered from severe pre-eclamptic toxaemia , or if Rh or ABO antibodies were found in their blood . Babies whose birth weight was under 5 lb . 4 oz . ( 2,380 g. ) or who developed neonatal sepsis were also excluded . All other mothers with live-born babies were assigned to one or other group . The babies ' serum bilirubin was determined on the third and sixth days of life . The results are shown in the Table , in which the mean serum bilirubin figures for each group as well as the st and ard deviation and range are given . It can be seen that the mean levels did not exceed 6.1 mg./100 ml . in any group on either the third or sixth day . Indeed , the group receiving the larger dose of promazine ( 50 mg . ) had the lowest mean serum bilirubin figures . If a level of over 15 mg./100 ml . is taken to indicate hyperbilirubinaemia there were no cases of this in our series . In addition no deleterious effect result ed if the drugs had to be repeated . Two women in group 1 were given 50 mg . of promazine Two series of patients , r and omly selected , 29 of whom had pethidine and 29 of whom had a placebo , were compared in order to study the influence of intra-muscular pethidine on uterine activity and on the speed with which the cervix dilated . The experiment was a double blind one . A significant increase in the basal tone of the uterine muscle was found 40 minutes after the injection in the group that received pethidine , although there was no other significant difference in the other parameters which were intensity , frequency , length , surface of the contractions [ half the height multiplied by ( X times ) the base on the monitor recording ] , uterine activity in Montevideo and in Toulouse units and the speed of dilatation . These results do not bear out the classical hypotheses of the muscle relaxing effect of pethidine , and in particular that the uterus relaxes better between contractions , nor that there is relaxation of the cervix in labour . The indication for the use of pethidine is perhaps justified because of its analgesic effect , but as far as favouring dilatation of the cervix in labour is concerned is at best worthy of discussion The feasibility of patient-controlled on-dem and analgesia by the intramuscular route during labour was tested on 10 primigravid mothers . Pethidine 50 mg or meptazinol 75 mg was available double-blind at minimum intervals of 20 min . The mean dose dem and ed was 190 ( SD 96.2 ) mg of pethidine and 285 ( SD 97.8 ) mg of meptazinol . The dose of pethidine is similar to that dem and ed by the intravenous route . Pain evaluations were not significantly different , but one mother who had meptazinol opted for epidural analgesia , and 2 wished they had done so . The system could be easily managed by all the mothers and there were not technical difficulties . Self-administered intramuscular analgesia could be instituted by a midwife with a dosage scheme similar to current practice . A field trial by midwives of self-administered intramuscular analgesia with pethidine is indicated Preliminary results on the disposition of meptazinol in the neonate are review ed . Meptazinol has a half-life of 3.4 hours compared with 22.7 hours for pethidine . In a r and omised double blind trial of 100 patients the depressant effects in the newborn of meptazinol and pethidine were compared . There was no difference in the Apgar scores at 1 and 3 minutes . Weight loss and the incidence of neonatal jaundice were less when mothers received meptazinol although these differences did not reach statistical significance . However , the number of infants considered fit for discharge by the 6th day was significantly greater in the meptazinol groups . In 43 cases transcutaneous monitoring of arterial PO2 was carried out for 30 minutes following delivery . Although the mean PaO2 was similar for meptazinol and pethidine , significant variations in the PaO2 of 2.0 kPa or greater and significant neonatal activity as judged by episodes of crying and movement , were recorded in the meptazinol group . The results of the trial suggest that meptazinol may have less depressant effects on the newborn , and may be preferable to pethidine as an obstetric analgesic We compared the analgesic efficacy and safety of remifentanil and pethidine via patient controlled analgesia for women in established uncomplicated labour . Women received either remifentanil 40 μg with a 2‐min lockout ( n = 20 ) or pethidine 15 mg with a 10‐min lockout ( n = 19 ) . Visual analogue scores for pain during the study and for overall pain were similar for both groups ( mean ( SD ) 6.4 ( 1.5 ) cm for remifentanil and 6.9 ( 1.7 ) cm for pethidine ) . The area under the curve for visual analogue scores of satisfaction with analgesia was higher for remifentanil than for pethidine ( p = 0.001 ) . Maternal arterial oxygen saturation was similar in both groups . Neurologic and Adaptive Capacity Scores at 30 min were higher for remifentanil than for pethidine ( median ( interquartile range [ range ] ) 36 ( 34.5–37 [ 32–39 ] ) vs 34 ( 33–35 [ 30–35 ] ) , respectively ; p = 0.003 ) The use of meperidine in obstetrical analgesia and its limits have been studied above all in connection with the most common neonatal data [ l , 7 , 14 , 19 ] . ESCARDO DE CORIAT 'S research es in 1966 pointed out for the first time an impairment of responsiveness to Stimuli in babies born to mothers premedicated with analgetics in labor , particularly with meperidine . A deeper evaluation of these aspects of the neonatal Status was made by BRAZELTON who , using his own neurobehavioral scale , described similar observations in 1973 [ 5 ] and confirmed them in 1977 [ 6 ] . BORGSTEDT [ 3 ] came to the same conclusions using the techniques of BRECHTL-BEINTEMA at 36 and 72 hours from birth . BRACKBILL [ 4 ] demonstrated that only some behavioral parameters of the infants were altered at birth in newborns exposed to meperidine ( interest in voice , defence , consolability and so on ) . When new experiments were made with different neurobehavioral and attitudinal tests ( SCANLON test ) and different Stimuli [ 8 , 15 , 17 ] , remarkable differences were always noticed between groups of babies exposed to meperidine and not exposed ones . After the result of the previous research es we thought it useful to verify the effects of the association of meperidine and promethazine on the Curriculum ASPHYXIA is a common cause of stillbirth and , therefore , factors affecting oxygenation of the mother or fetus deserve investigation . Morphine is used for pain relief in obstetrics and it is known to depress respiration , probably by acting on the respiratory centres of the brain stem ( Goodman and Gilman , 1965 ) . The respiratory depression is discernible even with doses too small to produce sleep or disturb consciousness , and increases progressively as the dose increases . Within minutes of the intravenous injection of morphine there is a decrease in minute ventilation , followed by an increase in carbon dioxide tension in the blood and alveolar air ( Goodman and Gilman , 1965 ) . A similar effect on respiration is found after subcutaneous or intramuscular injection of 10 to 20 mg . , although the time of maximum depression of respiration varies from 30 to 90 minutes ( Dripps and Comroe , 1945 ) . The present study was design ed to determine the effect , if any , of the intramuscular injection of 15 mg . morphine upon maternal capillary blood Po , and Pco , OBJECTIVE To determine the effectiveness and side effects of intravenous meperidine in labour pain relief . MATERIAL AND METHOD A double blind , r and omized controlled trial was conducted in 84 parturients , using normal saline as control . Visual analogue scale , postpartum parturients ' opinion of effectiveness , sedative scores , nausea/vomiting , dizziness , delivery method , Apgar scores , and naloxone prescription were assessed . RESULT There were no statistically significant differences between the mean and median of visual analogue scale of meperidine and control group . In addition , the sedative scores , nausea/vomiting and dizziness in the meperidine group occurred more than those in the control group significantly . Even mean of the pain increment in the meperidine group was less than those in the control group ( p < 0.05 ) . The parturients ' opinion on the effectiveness of pain relief during labor within 24 hours of the first postpartum day was only 23.80 per cent in the meperidine group , however , it was statistically significantly different when compared to 7.10 per cent in the control group . CONCLUSION Intravenous meperidine exhibited the effectiveness of pain relief of only 23.80 per cent of the subjects , in addition , it may cause many side effects Parenteral analgesia with Tramal was performed in 23 normal deliveries . The results were compared with a group of normal deliveries in which analgesia was achieved with pethidine . Both medicaments excerted an identical analgetic efficiency . No adverse side effects were observed with Tramal concerning the follow-up of labour or the newborn . Tramal can be recommended for obstetrical analgesia since it does not excert inhibitory effects upon the respiratory center |
1,394 | 31,376,293 | Neurodevelopmental impairment was assessed in a minority of surviving children . | INTRODUCTION Severe early-onset fetal growth restriction is an obstetric condition with significant risks of perinatal mortality , major and minor neonatal morbidity , and long-term health sequelae .
The prognosis of a fetus is influenced by the extent of prematurity and fetal weight .
Clinical care is individually adjusted .
In literature , survival rates described vary and studies often only include live born neonates with missing rates of antenatal death .
This systematic review aims to summarize the literature on mortality and morbidity . | Abstract Aims : Severe preterm fetal growth restriction ( FGR ) remote from term is problematic . We aim ed to investigate the effect of maternally-administered antithrombin on maternal and neonatal outcomes . A prospect i ve , one-arm , pilot study was performed in 14 women with severe FGR ( ≤5th centile ) at < 28 weeks of gestation , without hypertensive disorders . Maternal plasma concentrations of soluble Feline McDonough Sarcoma (FMS)-like trypsin kinase-1 ( sFlt-1 ) and placental growth factor ( PlGF ) were measured and categorized into three groups : group 1 ; low sFlt-1 and high PlGF , group 2 ; moderate sFlt-1 and low PlGF , and group 3 ; high sFlt-1 and low PlGF . Antithrombin was administered for 3 days . The incidence of perinatal mortality , infant morbidity , and the period of pregnancy prolongation were compared . Results : In group 1 ( n=4 ) , their pregnancies were extended for longer periods and the maternal and infant outcomes were good . The prolongation periods were shorter in groups 2 ( n=3 ) and 3 ( n=7 ) , which result ed in poor maternal [ severe preeclampsia or hemolysis , elevated liver enzymes , and low platelet count ( HELLP ) syndrome ] and infant outcomes . Conclusions : The evaluation of the maternal sFlt-1 and PlGF at 21–27 weeks of gestation is useful in the managements of severe FGR . Antithrombin treatment could prolong the pregnancies with low sFlt-1 and high PlGF without negatively affecting maternal or fetal health BACKGROUND No consensus exists for the best way to monitor and when to trigger delivery in mothers of babies with fetal growth restriction . We aim ed to assess whether changes in the fetal ductus venosus Doppler waveform ( DV ) could be used as indications for delivery instead of cardiotocography short-term variation ( STV ) . METHODS In this prospect i ve , European multicentre , unblinded , r and omised study , we included women with singleton fetuses at 26 - 32 weeks of gestation who had very preterm fetal growth restriction ( ie , low abdominal circumference [ < 10th percentile ] and a high umbilical artery Doppler pulsatility index [ > 95th percentile ] ) . We r and omly allocated women 1:1:1 , with r and omly sized blocks and stratified by participating centre and gestational age ( < 29 weeks vs ≥29 weeks ) , to three timing of delivery plans , which differed according to antenatal monitoring strategies : reduced cardiotocograph fetal heart rate STV ( CTG STV ) , early DV changes ( pulsatility index > 95th percentile ; DV p95 ) , or late DV changes ( A wave [ the deflection within the venous waveform signifying atrial contraction ] at or below baseline ; DV no A ) . The primary outcome was survival without cerebral palsy or neurosensory impairment , or a Bayley III developmental score of less than 85 , at 2 years of age . We assessed outcomes in surviving infants with known outcomes at 2 years . We did an intention to treat study for all participants for whom we had data . Safety outcomes were deaths in utero and neonatal deaths and were assessed in all r and omly allocated women . This study is registered with IS RCT N , number 56204499 . FINDINGS Between Jan 1 , 2005 and Oct 1 , 2010 , 503 of 542 eligible women were r and omly allocated to monitoring groups ( 166 to CTG STV , 167 to DV p95 , and 170 to DV no A ) . The median gestational age at delivery was 30·7 weeks ( IQR 29·1 - 32·1 ) and mean birthweight was 1019 g ( SD 322 ) . The proportion of infants surviving without neuroimpairment did not differ between the CTG STV ( 111 [ 77 % ] of 144 infants with known outcome ) , DV p95 ( 119 [ 84 % ] of 142 ) , and DV no A ( 133 [ 85 % ] of 157 ) groups ( ptrend=0·09 ) . 12 fetuses ( 2 % ) died in utero and 27 ( 6 % ) neonatal deaths occurred . Of survivors , more infants where women were r and omly assigned to delivery according to late ductus changes ( 133 [ 95 % ] of 140 , 95 % , 95 % CI 90 - 98 ) were free of neuroimpairment when compared with those r and omly assigned to CTG ( 111 [ 85 % ] of 131 , 95 % CI 78 - 90 ; p=0.005 ) , but this was accompanied by a non-significant increase in perinatal and infant mortality . INTERPRETATION Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint , timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at 2 years of age . FUNDING ZonMw , The Netherl and s and Dr Hans Ludwig Geisenhofer Foundation , Germany OBJECTIVE The objective of the study was to describe neurodevelopmental outcome at the age of 4.5 years in 216 children , born after expectant management of severe early-onset hypertensive complications of pregnancy . STUDY DESIGN This was a prospect i ve follow-up study until age 4.5 years from maternal admission onward . Developmental outcome measurements included child intelligence quotient and behavioral , motor , and neurological outcome . Abnormal composite outcome ( perinatal mortality or abnormal developmental outcome ) was studied in relation to gestational age ( GA ) , birthweight ( BW ) , and perinatal variables . RESULTS Fetal and neonatal mortality was 9 % and 8 % , respectively . Of the 178 survivors , 149 ( 84 % ) were seen for follow-up . Mean GA was 31.4 weeks and 90 % were born growth restricted . Abnormal developmental outcome occurred in 20 % and abnormal composite outcome in 37 % . CONCLUSION Perinatal mortality or abnormal child development occurs in one third of pregnancies with early-onset and severe hypertensive complications and is highest in the lowest GA and BW ranges OBJECTIVES Few data exist for counseling and perinatal management of women after an antenatal diagnosis of early-onset fetal growth restriction . Yet , the consequences of preterm delivery and its attendant morbidity for both mother and baby are far reaching . The objective of this study was to describe perinatal morbidity and mortality following early-onset fetal growth restriction based on time of antenatal diagnosis and delivery . METHODS We report cohort outcomes for a prospect i ve multicenter r and omized management study of fetal growth restriction ( Trial of R and omized Umbilical and Fetal Flow in Europe ( TRUFFLE ) ) performed in 20 European perinatal centers between 2005 and 2010 . Women with a singleton fetus at 26 - 32 weeks of gestation , with abdominal circumference < 10(th ) percentile and umbilical artery Doppler pulsatility index > 95(th ) percentile , were recruited . The main outcome measure was a composite of fetal or neonatal death or severe morbidity : survival to discharge with severe brain injury , bronchopulmonary dysplasia , proven neonatal sepsis or necrotizing enterocolitis . RESULTS Five-hundred and three of 542 eligible women formed the study group . Mean ± SD gestational age at diagnosis was 29 ± 1.6 weeks and mean ± SD estimated fetal weight was 881 ± 217 g ; 12 ( 2.4 % ) babies died in utero . Gestational age at delivery was 30.7 ± 2.3 weeks , and birth weight was 1013 ± 321 g. Overall , 81 % of deliveries were indicated by fetal condition and 97 % were by Cesarean section . Of 491 liveborn babies , outcomes were available for 490 amongst whom there were 27 ( 5.5 % ) deaths and 118 ( 24 % ) babies suffered severe morbidity . These babies were smaller at birth ( 867 ± 251 g ) and born earlier ( 29.6 ± 2.0 weeks ) . Death and severe morbidity were significantly related to gestational age , both at study entry and delivery and also with the presence of maternal hypertensive morbidity . The median time to delivery was 13 days for women without hypertension , 8 days for those with gestational hypertension , 4 days for pre-eclampsia and 3 days for HELLP syndrome . CONCLUSIONS Fetal outcome in this study was better than expected from contemporary reports : perinatal death was uncommon ( 8 % ) and 70 % survived without severe neonatal morbidity . The intervals to delivery , death and severe morbidity were related to the presence and severity of maternal hypertensive conditions OBJECTIVE To test the effect of aspirin and omega 3 on fetal weight as well as feto-maternal blood flow in asymmetrical intrauterine growth restriction ( IUGR ) . STUDY DESIGN This study is a clinical ly registered ( NCT02696577 ) , open , parallel , r and omized controlled trial , conducted at Assiut Woman 's Health Hospital , Egypt including 80 pregnant women ( 28 - 30 weeks ) with IUGR . They were r and omized either to group I : aspirin or group II : aspirin plus omega 3 . The primary outcome was the fetal weight after 6 weeks of treatment . Secondary outcomes included Doppler blood flow changes in both uterine and umbilical arteries , birth weight , time and method of delivery and admission to NICU . The outcome variables were analyzed using paired and unpaired t-test . RESULTS The estimated fetal weight increased significant in group II more than group I ( p=0.00 ) . The uterine and umbilical arteries blood flow increased significantly in group II ( p<0.05 ) . The birth weight in group II was higher than that observed in group I ( p<0.05 ) . CONCLUSION The using of aspirin with omega 3 is more effective than using aspirin only in increasing fetal weight and improving utero-placental blood flow in IUGR AIM We design ed a safety and dose-finding trial of tadalafil administered for fetal growth restriction ( FGR ) . METHODS Three cases were initially commenced on 10 mg/day and monitored for major adverse events . Should a major adverse event be observed in one or more of the three cases , an examination into its relation with tadalafil would be conducted by a safety evaluation committee . If one or more of these new cases exhibited the same adverse event , the trial would be stopped completely . If there were no harmful side-effects , the trial would be extended to three cases at 20 mg/day , and the protocol would continue as in the 10-mg/day dose . The 40-mg/day dosage was tried in six cases as the dosage was considered to be high . RESULTS The study population consisted of pregnant women with FGR . Maternal adverse events in all doses were recorded as least one grade 1 adverse events , as tadalafil was considered acceptable from the viewpoint of the mothers . However , a dose of 40 mg/day increased the number of grade 1 adverse events . The only fetal adverse event was a case of intrauterine fetal death related to the velamentous insertion of the umbilical cord . Neonatal adverse events showed no correlation to tadalafil dose , but were found more frequently in preterm births and , therefore , were correlated to infant prematurity . CONCLUSION This safety and dose-finding trial showed that tadalafil had a favorable safety profile for pregnant women and fetuses with FGR AIM The prognosis for severe fetal growth restriction ( FGR ) with severe oligohydramnios before 26 weeks ' gestation ( WG ) is currently poor ; furthermore , its management is controversial . We report the innovative new management of FGR , such as therapeutic amnioinfusion and tocolysis . MATERIAL AND METHODS For FGR and severe oligohydramnios before 26 WG complicated with absent or reversed umbilical artery end-diastolic flow velocity and /or deceleration by ultrasonography , we performed transabdominal amnioinfusion with tocolysis . Cases with multiple anomalies were excluded . Survival rate and long-term prognosis were analyzed . RESULTS Among 570 FGR cases , 18 were included in the study . Mean diagnosis and delivery were at 22.6 ± 2.0 and 28.7 ± 3.3 WG . Median birthweight was 625 g ( -4.2 st and ard deviation ) . Final survival rate was 11/13 ( 85 % ) . There were five fetal deaths . In seven cases , oligohydramnios improved . Growth was detected in 10/18 fetuses . Furthermore , 8/8 decelerations , 4/12 cases of reversed umbilical artery end-diastolic flow velocity , 7/14 cases of brain-sparing effect , and 6/13 venous Doppler abnormalities were improved . When we detected umbilical cord compression , 8/10 cases were rescued . Eleven infants were followed up for an average of 5 years ; one case of cerebral palsy with normal development and 10 cases with intact motor functions without major neurological h and icap were confirmed . CONCLUSIONS In cases of extremely severe FGR before 26 WG with oligohydramnios and circulatory failure , amnioinfusion might be a promising , innovative tool This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence Abstract Objective : To investigate the effect of aspirin on fetal weight in fetuses with idiopathic asymmetrical intrauterine growth restriction ( IUGR ) complicated by abnormal umbilical artery Doppler indices . Material s and methods : The study was a r and omized controlled trial conducted at Woman ’s Health Hospital , Assiut , Egypt , between June 2016 and the January 2017 included 60 pregnant women ( 28−30 weeks ) with idiopathic asymmetrical IUGR associated with abnormal umbilical artery Doppler indices . Women were r and omly assigned to group I ( aspirin 75 mg ) daily for four weeks or group II ( no intervention ) . The primary outcome was the fetal weight after four weeks . Secondary outcomes included Doppler blood flow changes in the umbilical artery plus delivery and neonatal outcomes . Results : The estimated fetal weight and umbilical artery blood flow increased significantly in aspirin group ( p = .00 ) when compared with no intervention group . As regard neonatal outcomes ; aspirin group showed better results and encouraging outcomes ( p < .05 ) . Conclusions : Aspirin improves fetal weight and umbilical artery blood flow in idiopathic asymmetrical IUGR fetuses complicated by abnormal umbilical artery Doppler blood flow OBJECTIVE Intrauterine growth restriction ( IUGR ) is one of the most serious complications of pregnancy . Up to date , there is no evidence of achieving antenatal treatment of IUGR with abnormal placentation . Although , Sildenafil citrate has shown promising results , there are no firm conclusion till now . The aim of our study is to evaluate the use of Sildenafil citrate in the treatment of IUGR cases associated with impaired placental circulation . MATERIAL S AND METHODS This was a prospect i ve non-r and omized study conducted at Mansoura university hospitals starting from March 2016 till October 2017 . The studied population included singleton pregnancy and suffering from IUGR associated with impaired placental circulation . RESULTS This study included 50 pregnant women . Cases were divided into two groups . The first group received sildenafil citrate and the second control group did not receive sildenafil citrate . After 4 weeks after the 1st dose of Sildenafil significant decrease in umbilical artery Doppler indices . There was a statistically significant difference in the mean birth weight at delivery and neonatal admission to the newborn nursery in sildenafil group . CONCLUSION sildenafil citrate treatment may present a new hope towards better perinatal outcomes for pregnancies complicated by IUGR and impaired placental circulation that may help to decrease neonatal admission to the newborn nursery BACKGROUND Severe early-onset fetal growth restriction can lead to a range of adverse outcomes including fetal or neonatal death , neurodisability , and lifelong risks to the health of the affected child . Sildenafil , a phosphodiesterase type 5 inhibitor , potentiates the actions of nitric oxide , which leads to vasodilatation of the uterine vessels and might improve fetal growth in utero . METHODS We did this superiority , placebo-controlled r and omised trial in 19 fetal medicine units in the UK . We used r and om computer allocation ( 1:1 ) to assign women with singleton pregnancies between 22 weeks and 0 days ' gestation and 29 weeks and 6 days ' gestation and severe early-onset fetal growth restriction to receive either sildenafil 25 mg three times daily or placebo until 32 weeks and 0 days ' gestation or delivery . We stratified women by site and by their gestational age at r and omisation ( before week 26 and 0 days or at week 26 and 0 days or later ) . We defined fetal growth restriction as a combination of estimated fetal weight or abdominal circumference below tenth percentile and absent or reversed end-diastolic blood flow in the umbilical artery on Doppler velocimetry . The primary outcome was the time from r and omisation to delivery , measured in days . This study is registered with BioMed Central , number IS RCT N 39133303 . FINDINGS Between Nov 21 , 2014 , and July 6 , 2016 , we recruited 135 women and r and omly assigned 70 women to sildenafil and 65 women to placebo . We found no difference in the median r and omisation to delivery interval between women assigned to sildenafil ( 17 days [ IQR 7 - 24 ] ) and women assigned to placebo ( 18 days [ 8 - 28 ] ; p=0·23 ) . Livebirths ( relative risk [ RR ] 1·06 , 95 % CI 0·84 to 1·33 ; p=0·62 ) , fetal deaths ( 0·89 , 0·54 to 1·45 ; p=0·64 ) , neonatal deaths ( 1·33 , 0·54 to 3·28 ; p=0·53 ) , and birthweight ( -14 g,-100 to 126 ; p=0·81 ) did not differ between groups . No differences were found for any other secondary outcomes . Eight serious adverse events were reported during the course of the study ( six in the placebo group and two in the sildenafil group ) ; none of these were attributed to sildenafil . INTERPRETATION Sildenafil did not prolong pregnancy or improve pregnancy outcomes in severe early-onset fetal growth restriction and therefore it should not be prescribed for this indication outside of research studies with explicit participants ' consent . FUNDING National Institute for Health Research and Medical Research Council |
1,395 | 31,638,271 | There is moderate-certainty evidence that automated text message-based smoking cessation interventions result in greater quit rates than minimal smoking cessation support .
There is moderate-certainty evidence of the benefit of text messaging interventions in addition to other smoking cessation support in comparison with that smoking cessation support alone . | BACKGROUND Mobile phone-based smoking cessation support ( mCessation ) offers the opportunity to provide behavioural support to those who can not or do not want face-to-face support .
In addition , mCessation can be automated and therefore provided affordably even in re source -poor setting s. This is an up date of a Cochrane Review first published in 2006 , and previously up date d in 2009 and 2012 .
OBJECTIVES To determine whether mobile phone-based smoking cessation interventions increase smoking cessation rates in people who smoke . | Objective : To assess the efficacy of an innovative smoking cessation intervention targeted to a multiethnic , economically disadvantaged HIV-positive population . Design : A two-group r and omized clinical trial compared a smoking cessation intervention delivered by cellular telephone with usual care approach . Methods : Current smokers from a large , inner city HIV/AIDS care center were recruited and r and omized to receive either usual care or a cellular telephone intervention . The usual care group received brief physician advice to quit smoking , targeted self-help written material s and nicotine replacement therapy . The cellular telephone intervention received eight counseling sessions delivered via cellular telephone in addition to the usual care components . Smoking-related outcomes were assessed at a 3-month follow-up . Results : The trial had 95 participants and 77 ( 81.0 % ) completed the 3-month follow-up assessment . Analyses indicated biochemically verified point prevalence smoking abstinence rates of 10.3 % for the usual care group and 36.8 % for the cellular telephone group ; participants who received the cellular telephone intervention were 3.6 times ( 95 % confidence interval , 1.3 - 9.9 ) more likely to quit smoking compared with participants who received usual care ( P = 0.0059 ) . Conclusions : These results suggest that individuals living with HIV/AIDS are receptive to , and can be helped by , smoking cessation treatment . In addition , smoking cessation treatment tailored to the special needs of individuals living with HIV/AIDS , such as counseling delivered by cellular telephone , can significantly increase smoking abstinence rates over that achieved by usual care Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones . This social cognitive theory-based intervention ( called “ STUB IT ” ) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques . Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation . Methods A r and omized controlled trial was conducted with 6-month follow-up . Participants had to be 16 years of age or over , be current daily smokers , be ready to quit , and have a video message-capable phone . Recruitment targeted younger adults predominantly through radio and online advertising . Registration and data collection were completed online , prompted by text messages . The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date , role model , and timing of messages . Extra messages were available on dem and to beat cravings and address lapses . The control group also set a quit date and received a general health video message sent to their phone every 2 weeks . Results The target sample size was not achieved due to difficulty recruiting young adult quitters . Of the 226 r and omized participants , 47 % ( 107/226 ) were female and 24 % ( 54/226 ) were Maori ( indigenous population of New Zeal and ) . Their mean age was 27 years ( SD 8.7 ) , and there was a high level of nicotine addiction . Continuous abstinence at 6 months was 26.4 % ( 29/110 ) in the intervention group and 27.6 % ( 32/116 ) in the control group ( P = .8 ) . Feedback from participants indicated that the support provided by the video role models was important and appreciated . Conclusions This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone . However , there was sufficient positive feedback about the ease of use of this novel intervention , and the support obtained by observing the role model video messages , to warrant further investigation . Trial registration Australian New Zeal and Clinical Trials Registry Number : ACTRN12606000476538 ; http://www.anzctr.org.au/trial_view.aspx?ID=81688 ( Archived by WebCite at http://www.webcitation.org/5umMU4sZi Summary We evaluated the effectiveness of a mobile phone text-messaging based smoking cessation intervention package among Chinese adolescent smokers . Students aged 16–19 years were recruited from six vocational high schools located in Shanghai . We assigned the six schools to an intervention group or a control group by cluster r and omization . The 92 participants in the intervention group were given tailored information via mobile phone text-messaging for 12 weeks . The 87 participants in the control group were provided with a self-help pamphlet about smoking cessation instead . After the intervention , attitudes towards the disadvantages of smoking were significantly improved , and the level of nicotine dependence and cigarette dependence significantly decreased in the intervention group . The intervention group had a relatively higher self-reported 7-day abstinence compared to the control group and 30-day abstinence , but the differences were not significant . However , the intervention group had a significantly higher rate of smoking reduction ( 66 % vs. 35 % ) and moving forward in quitting stages ( 52 % vs. 18 % ) compared to the control group . The interactive and tailored assistance provided by the mobile phone text-messaging was effective in smoking behaviour intervention in Chinese adolescent smokers Mounting evidence suggests that smokers living with HIV/AIDS have a significantly increased risk of numerous adverse health outcomes ( both AIDS- and non-AIDS-related ) compared with HIV-positive nonsmokers . Therefore , efforts to design and implement effective cessation programs for this ever-growing special population are warranted . The present study assessed the effects of a cell phone intervention ( CPI ) on hypothesized mediators ( i.e. , changes in depression , anxiety , social support , and self-efficacy ) demonstrated to influence cessation outcomes in other population s. Ninety-five participants from an inner-city AIDS clinic were r and omized to receive either the CPI or recommended st and ard of care ( RSOC ) smoking cessation treatment . Participants r and omized to the RSOC group ( n=47 ) received brief advice to quit , a 10-week supply of nicotine patches , and self-help material s. Participants r and omized to the CPI group ( n=48 ) received RSOC components plus a series of eight proactive counseling sessions delivered via cell phones . A series of regression analyses ( linear and logistic ) was used to assess the relationships between treatment group , the hypothesized mediators , and biochemically confirmed smoking cessation outcomes . Results indicated that the CPI group experienced greater reductions in anxiety and depression , and increases in self-efficacy compared with the RSOC group . Further , changes in depression , anxiety , and self-efficacy weakened the association between treatment group and cessation outcome . The mediator hypothesis , however , for social support was rejected , as the difference score was not significantly associated with treatment group . These results suggest that the efficacy of the CPI is at least partially mediated by its ability to decrease symptoms of distress while increasing self-efficacy The psychological construct , readiness to change , is established as a central construct within behavioral change theories such as motivational interviewing ( MI ) . Less is known about the interplay of mechanisms for change within adolescent treatment population s. Underst and ing the timing and interactive influence that adolescents ' readiness to stop smoking and peer smoking have on subsequent tobacco use is important to advance intervention research . Toward this end , we used ecological momentary assessment ( EMA ) data from an automated texting smoking intervention r and omized controlled trial to model the interactive effects of readiness to stop smoking and friends smoking on adolescent tobacco use . Two hundred adolescents were r and omized into experimental treatment or attention control conditions , provided smart phones , and were followed for 6 months . African American youth represented the majority of the sample . We collected monthly EMA data for 6 months on friends smoking and readiness to stop smoking as well as survey outcome data . We tested a moderated mediation model using bias corrected bootstrapping to determine if the indirect effect of treatment on cigarettes smoked through readiness to stop smoking was moderated by friends smoking . Findings revealed that readiness to stop smoking mediated the effects of treatment on cigarettes smoked for those adolescents with fewer friends smoking , but not for those with more friends smoking . These results support importance of peer-focused interventions with urban adolescents and provide target mechanisms for future research Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease , providing access to such interventions is a major challenge . This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk . Methods and analysis R and omised controlled trial with 6 months of follow-up to evaluate the feasibility , acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care . A total of 720 patients with coronary artery disease will be r and omised to either st and ard care or the TEXT ME intervention . The intervention group will receive multiple weekly text messages that provide information , motivation , support to quit smoking ( if relevant ) and recommendations for healthy diets and exercise . The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months . Secondary end points include a change in systolic blood pressure , smoking status , quality of life , medication adherence , waist circumference , physical activity levels , nutritional status and mood at 6 months . Process outcomes related to acceptability and feasibility of TEXT ME will also be collected . Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee — Westmead . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences . Clinical trials registration number ACTRN12611000161921 INTRODUCTION Substantial evidence indicates that cigarette smoking among people living with HIV/AIDS ( PLWHA ) represents a significant public health concern . However , few efforts to assess smoking cessation interventions targeting this population have been reported . In this brief report , 3-month outcomes from an ongoing treatment trial for PLWHA who smoke are described . METHODS Study participants were recruited from a large HIV care center serving a diverse population of PLWHA . A two-group r and omized design was used to compare the efficacy of usual-care ( UC ) smoking cessation treatment versus a cell phone intervention ( CPI ) . Follow-ups were conducted at the HIV clinic 3 months postenrollment . Using an intent-to-treat approach , a series of multiple regression models were used to compare smoking outcomes in the 2 groups . RESULTS Four hundred and seventy-four participants were enrolled and r and omized , UC ( n = 238 ) and CPI ( n = 236 ) . Mean age in the sample was 44.8 ( SD = 8.1 ) years , and the majority were male ( 70.0 % ) , Black ( 76.6 % ) , and had an education level of high school or less ( 77.5 % ) . At follow-up , participants in the CPI group were 4.3 ( 95 % CI = 1.9 , 9.8 ) times more likely to be abstinent ( 7 day ) compared with those in the UC group . Similarly , significant point estimates were observed for the other smoking outcomes of interest . CONCLUSIONS Findings from this preliminary report indicate that a smoking cessation intervention for PLWHA consisting of cell phone-delivered proactive counseling results in significantly higher abstinence rates compared with a st and ard care approach . Evaluation of the long-term ( 6-month and 12-month ) efficacy of the CPI approach is ongoing Background The study aims to test the differential effects of a web-based text and a web-based video-driven computer-tailored approach for lower socio-economic status ( LSES ) and higher socio-economic status ( HSES ) smokers which incorporate multiple computer-tailored feedback moments . The two programs differ only in the mode of delivery ( video- versus text-based messages ) . The paper aims to describe the development and design of the two computer-tailored programs . Methods / design Respondents who smoked at the time of the study inclusion , who were motivated to quit within the following six months and who were aged 18 or older were included in the program . The study is a r and omized control trial with a 2 ( video/text ) * 2(LSES/HSES ) design . Respondents were assigned either to one of the intervention groups ( text versus video tailored feedback ) or to the control group ( non-tailored generic advice ) . In all three conditions participants were asked to fill in the baseline question naire based on the I-Change model . The question naire assessed socio-demographics , attitude towards smoking , knowledge , self-efficacy , social influence , depression , level of addiction , action planning , goal actions , intention to quit smoking , seven-day point prevalence and continued abstinence . Follow-up measurements were conducted at six and twelve months after baseline . Discussion The present paper describes the development of the two computer-tailored smoking cessation programs , their components and the design of the study . The study results reveal different working mechanisms of multiple tailored smoking cessation interventions and will help us to gain more insight into effective strategies to target different subgroups , especially smokers with a lower socio-economic status . Trial registration Dutch Trial Register Background Despite promising data in Western countries , there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other setting s , including the Middle East , where smoking prevalence rates are higher . Objective This paper reports cessation rates observed in SMS Turkey , a text messaging-based smoking cessation program for adult smokers in Ankara , Turkey . Methods This study was a small-scale , parallel-group r and omized controlled trial ( RCT ) conducted in Ankara , Turkey . Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara , Turkey . The text messaging intervention , SMS Turkey , provided 6 weeks of daily messages aim ed at giving participants skills to help them quit smoking . Messages were sent in an automated fashion , except 2 days and 7 days after the initial quit day . On days 2 and 7 , the research assistant manually assigned participants to content “ paths ” based on whether they were still not smoking or had relapsed . The control arm received a brochure that provided similar information about smoking cessation . The main outcome measure was self-reported 3-month sustained abstinence , verified by carbon monoxide ( CO ) readings . Neither participants nor research ers were blinded to arm assignment . Results The 151 participants were r and omly assigned to 1 of 2 groups : 76 to the SMS Turkey intervention group and 75 to the brochure control group . Using intention to treat , all 151 participants were included in analyses . Three-month cessation trends were not significantly higher in the intervention group : 11 % intervention vs 5 % control had quit ( χ2 1=1.4 , P=.24 ; R2=2.0 , 95 % CI 0.62 - 6.3 ) . When the sample was stratified by sex , female intervention participants ( 14 % , n=5 ) were significantly more likely to have quit at 3 months than female control participants ( 0 % , n=0 ; χ2 1=3.7 , P=.05 ) . Among light smokers ( ie , those smoking less than 20 cigarettes per day ) , intervention participants ( 17 % , n=5 ) also were significantly more likely to have quit compared to control participants ( 0 % , n=0 ; χ2 1=5.3 , P=.02 ) . We noted no difference in cessation rates for males or heavy smokers . Participants experienced significant technology problems during the study . Some participants received duplicate text messages at least once during the trial ; others failed to receive some program messages . Neither receiving duplicate messages ( χ2 1=0.12 , P=.73 ) , or missing 5 or more program messages ( χ2 1=0.75 , P=.39 ) negatively affected quitting rates . Conclusions Although the study was not powered to detect statistically significant differences , as the primary aim was to provide estimates of effect size that could be used to better inform a power analysis for a larger trial , findings provide optimism that SMS Turkey may be able to affect quitting rates in environments with high smoking prevalence , such as Ankara , Turkey . The SMS Turkey software program did not work as well as it did 2 years previous . The system will need to be up date d to maintain software compatibility with ongoing technology evolution . Trial Registration Clinical trials.gov NCT00912795 http:// clinical trials.gov/ct2/show/NCT00912795 ( Archived by WebCite at http://www.webcitation.org/6Ch1cIA8l ) Background Tobacco use is responsible for the death of about 1 in 10 individuals worldwide . Mindfulness training has shown preliminary efficacy as a behavioral treatment for smoking cessation . Recent advances in mobile health suggest advantages to smartphone-based smoking cessation treatment including smartphone-based mindfulness training . This study evaluates the efficacy of a smartphone app-based mindfulness training program for improving smoking cessation rates at 6-months follow-up . Methods / Design A two-group parallel-r and omized clinical trial with allocation concealment will be conducted . Group assignment will be concealed from study research ers through to follow-up . The study will be conducted by smartphone and online . Daily smokers who are interested in quitting smoking and own a smartphone ( n = 140 ) will be recruited through study advertisements posted online . After completion of a baseline survey , participants will be allocated r and omly to the control or intervention group . Participants in both groups will receive a 22-day smartphone-based treatment program for smoking . Participants in the intervention group will receive mobile mindfulness training plus experience sampling . Participants in the control group will receive experience sampling-only . The primary outcome measure will be one-week point prevalence abstinence from smoking ( at 6-months follow-up ) assessed using carbon monoxide breath monitoring , which will be vali date d through smartphone-based video chat . Discussion This is the first intervention study to evaluate smartphone-based delivery of mindfulness training for smoking cessation . Such an intervention may provide treatment in-h and , in real-world context s , to help individuals quit smoking . Trial registration Clinical trials.gov NCT02134509 . Registered 7 May 2014 Background Happy Ending ( HE ) is an intense 1-year smoking cessation program delivered via the Internet and cell phone . HE consists of more than 400 contacts by email , Web pages , interactive voice response , and short message service technology . HE includes a craving helpline and a relapse prevention system , providing just-in-time therapy . All the components of the program are fully automated . Objective The objectives were to describe the rationale for the design of HE , to assess the 12-month efficacy of HE in a sample of smokers willing to attempt to quit without the use of nicotine replacement therapy , and to explore the potential effect of HE on coping planning and self-efficacy ( prior to quitting ) and whether coping planning and self-efficacy mediate treatment effect . Methods A two-arm r and omized controlled trial was used . Subjects were recruited via Internet advertisements and r and omly assigned to condition . Inclusion criteria were willingness to quit on a prescribed day without using nicotine replacement and being aged 18 years or older . The intervention group received HE , and the control group received a 44-page self-help booklet . Abstinence was defined as “ not even a puff of smoke , for the last seven days ” and was assessed by means of Internet surveys or telephone interviews 1 , 3 , 6 , and 12 months postcessation . The main outcome was repeated point abstinence ( ie , abstinence at all four time points ) . Coping planning and self-efficacy were measured at baseline and at the end of the preparation phase ( ie , after 2 weeks of treatment , but prior to cessation day ) . Results A total of 290 participants received either the HE intervention ( n=144 ) or the control booklet ( n=146 ) . Using intent-to-treat analysis , participants in the intervention group reported clinical ly and statistically significantly higher repeated point abstinence rates than control participants ( 20 % versus 7 % , odds ratio [ OR ] = 3.43 , 95 % CI = 1.60 - 7.34 , P = .002 ) . Although no differences were observed at baseline , by the end of the preparation phase , significantly higher levels of coping planning ( t 261 = 3.07 , P = .002 ) and precessation self-efficacy ( t 261 = 2.63 , P = .01 ) were observed in the intervention group compared with the control group . However , neither coping planning nor self-efficacy mediated long-term treatment effect . For point abstinence 1 month after quitting , however , coping planning and self-efficacy showed a partial mediation of the treatment effect . Conclusions This 12-month trial documents a long-term treatment effect of a fully automated smoking cessation intervention without the use of nicotine replacement therapy . The study adds to the promise of using digital media in supporting behavior change The aim was to compare the effectiveness of untailored text messages for smoking cessation to tailored text messages delivered at a higher frequency . From February 2007 to August 2009 , 2030 users of an internet-based smoking cessation program with optional text message support aged 15 - 25 years were consecutively r and omized to versions of the program that offered either tailored or untailored text messages . Thirty-day point abstinence from smoking was measured self-reportedly at 12-months follow-up . Response rates were 36.3 % and 38.1 % in the tailored and untailored group , respectively . We analyzed the entire study population , as well as those opting for text messages ( n = 1619 ) . In intention-to-treat analysis with multiple imputation of missing data , the odds ratio for 30-day point abstinence was 1.28 ( 95 % CI 0.91 - 2.08 ) for the tailored compared with untailored messages . When restricting the analysis to those who had chosen to receive text messages , the corresponding odds ratio was 1.45 ( 95 % CI 1.01 - 2.08 ) . The higher long-term quit rates in the group receiving the tailored text messages compared with untailored text messages in the restricted analysis indicated that tailoring and higher frequency of text messages increases quit rates among young smokers The importance of patient satisfaction in modern healthcare is widely recognized , but research on satisfaction in the context of smoking cessation has not kept pace . The purpose of this study was to explore treatment satisfaction in a sample of smokers ( N=84 ) r and omized to one of two smoking cessation treatment interventions ( mHealth reinforcement and mHealth monitoring ) that used cell phone-based procedures to monitor smoking status in individuals ' natural environments for 4 weeks . Starting on the target quit date , participants received usual care smoking cessation treatment consisting of 8 weeks of transdermal nicotine and 4 weeks of twice-weekly telephone counseling were also prompted 1 to 3 times daily ( with exact number and timing not disclosed beforeh and ) to use a study cell phone and CO monitor to complete a CO self-test , video-record the process , and su bmi t videos using multimedia messaging within 2 hours . mHealth reinforcement participants could earn prizes for smoking-negative on-time CO tests . A treatment satisfaction survey was completed at the end of the 4-week monitoring/reinforcement phase . Results indicate that participants overwhelmingly endorsed high levels of overall satisfaction in both conditions . Treatment adherence did not differ between conditions , but was positively associated with endorsing the highest satisfaction with help quitting with the intervention ( p<.01 to .03 ) . mHealth reinforcement was associated with increased longest duration of abstinence ( p<.01 ) . Controlling for relevant participant characteristics and treatment adherence , longest duration of abstinence robustly predicted highest satisfaction with help quitting and mediated the effect of treatment condition on that satisfaction . Further research on treatment satisfaction may aid the development of effective abstinence reinforcement and other smoking cessation interventions BACKGROUND Tobacco dependence remains the leading preventable cause of death in the developed world . Smokers are disproportionately from lower socioeconomic groups , and may use the hospital emergency department ( ED ) as an important source of care . A recent clinical trial demonstrated the efficacy of a multicomponent intervention to help smokers quit , but the independent contributions of those components is unknown . METHODS This is a full-factorial ( 16-arm ) r and omized trial in a busy hospital ED of 4 tobacco dependence interventions : brief motivational interviewing , nicotine replacement therapy , referral to a telephone quitline , and a texting program . The trial utilizes the Multiphase Optimization Strategy ( MOST ) and a novel mixed methods analytic design to assess clinical efficacy , cost effectiveness , and qualitative participant feedback . The primary endpoint is tobacco abstinence at 3months , verified by participants ' exhaled carbon monoxide . RESULTS Study enrollment began in February 2017 . As of April 2017 , 52 of 1056 planned participants ( 4.9 % ) were enrolled . Telephone-based semi-structured participant interviews and in-person biochemical verification of smoking abstinence are completed at the 3-month follow-up . Efficacy and cost effectiveness analyses will be conducted after follow-up is completed . DISCUSSION The goal of this study is to identify a clinical ly efficacious , cost-effective intervention package for the initial treatment of tobacco dependence in ED patients . The efficacy of this combination can then be tested in a subsequent confirmatory trial . Our approach incorporates qualitative feedback from study participants in evaluating which intervention components will be tested in the future trial . TRIAL REGISTRATION Trial ( NCT02896400 ) registered in Clinical Trials.gov on September 6 , 2016 AIMS To determine the degree to which the observed benefit of Text2Quit was accounted for by psychosocial mechanisms derived from its quit smoking messaging versus from the use of extra-programmatic smoking cessation treatments and services . DESIGN Prospect i ve , multiple mediation model of a r and omized controlled trial ( RCT ) . SETTING United States nation-wide . PARTICIPANTS A total of 409 adult daily smokers participated . Participants were , on average , 35 years of age , predominantly female ( 68 % ) , white ( 79 % ) , lacked a college degree ( 70 % ) , had medium nicotine dependence ( average Fagerström Nicotine Dependence Score score of 5.2 ) and more than half ( 62 % ) had made a previous quit attempt . INTERVENTION Adult daily smokers browsing the web for smoking cessation support ( n = 409 ; recruited 19 May2011 - 10 July 2012 ) were r and omized to receive smoking cessation support via Text2Quit versus a smoking cessation material . MEASUREMENTS Mediators ( i.e. changes in psychosocial constructs of health behavior change , use of extra-programmatic treatment ) were assessed at 1 month using single-item measures and outcome ( i.e. self-reported 7-day point prevalence abstinence ) at 6-month follow-up . FINDINGS Mediators accounted for 35 % of the effect of Text2Quit on smoking cessation . Only psychosocial mechanisms had complete mediational paths , with increases in self-efficacy [ b = 0.10 ( 0.06 - 0.15 ) ] , quitting know-how [ b = 0.07 ( 0.03 - 0.11 ) ] and the sense that someone cared [ b = 0.06 ( 0.01 - 0.11 ) ] , partially explaining the conferred benefit of Text2Quit . Use of outside re sources , including treatments promoted explicitly by Text2Quit , i.e. medication [ b = 0.001 ( -0.01 to 0.01 ) , quitline [ b = -0.002 ( -0.01 to 0.04 ) ] , treatments and re sources not promoted by Text2Quit , i.e. online forums [ b = 0.01 ( -0.01 to 0.04 ) ] and self-help material s [ b = -0.01 ( -0.04 to 0.02 ) ] , did not have complete mediational paths . An interaction effect existed for medication use that suggested that for participants not using medication , Text2Quit conferred substantial benefit , but not for participants using medication . CONCLUSIONS Text-messaging programs for smoking cessation appear primarily to confer benefit by promoting improvements in the psychosocial processes related to quitting rather than through the use of extra-programmatic smoking cessation treatments and services Introduction Abstinence reinforcement is efficacious for improving smoking treatment outcomes , but practical constraints related to the need for multiple in-person carbon monoxide ( CO ) breath tests daily to verify smoking abstinence have limited its use . This study tested an mHealth procedure to remotely monitor and reinforce smoking abstinence in individuals ' natural environment . Methods Eligible treatment-seeking smokers ( N = 90 ) were r and omized to ( 1 ) usual care and ecological monitoring with abstinence reinforcement ( mHealth reinforcement ) or ( 2 ) without reinforcement ( mHealth monitoring ) . Usual care was 8 weeks of transdermal nicotine and twice-weekly telephone counseling . Following training , an interactive voice response system prompted participants to conduct CO tests 1 - 3 daily at pseudor and om times ( 7 am to 10 pm ) for 4 weeks . When prompted , participants used a study cell phone and CO monitor to complete a CO self-test , video record the process , and su bmi t videos using multimedia messaging . mHealth reinforcement participants could earn prizes for smoking-negative on-time CO tests . The interactive voice response generated preliminary earnings immediately . Earnings were finalized by comparing video records against participants ' self-reports . Results mHealth reinforcement was associated with a greater proportion of smoking-negative CO tests , longest duration of prolonged abstinence , and point-prevalence abstinence during the monitoring/reinforcement phase compared to mHealth monitoring ( p < .01 , d = 0.8 - 1.3 ) . Follow-up ( weeks 4 - 24 ) analyses indicated main effects of reinforcement on point-prevalence abstinence and proportion of days smoked ( p ≤ .05 ) ; values were comparable by week 24 . Conclusions mHealth reinforcement has short-term efficacy . Research on methods to enhance and sustain benefits is needed . Implication s This study suggests that mHealth abstinence reinforcement is efficacious and may present temporal and spatial opportunities to research , engage , and support smokers trying to quit that do not exist with conventional ( not technology-based ) reinforcement interventions Smoking represents an important health risk for people living with HIV ( PLHIV ) . Low adherence to smoking cessation pharmacotherapy may limit treatment effectiveness . In this study , 158 participants recruited from three HIV care centers in New York City were r and omized to receive 12-weeks of varenicline ( Chantix ) either alone as st and ard care ( SC ) or in combination with text message ( TM ) support or TM plus cell phone-delivered adherence-focused motivational and behavioral therapy ( ABT ) . Generalized linear mixed-effect models found a significant decline in varenicline adherence from week 1–12 across treatment groups . At 12-weeks , the probability of smoking abstinence was significantly higher in SC+TM+ABT than in SC . The study demonstrates the feasibility of delivering adherence-focused interventions to PLHIV who smoke . Findings suggest intensive behavioral support is an important component of an effective smoking cessation intervention for this population , and a focus on improving adherence self-efficacy may lead to more consistent adherence and higher smoking abstinence Background While gains in reducing smoking rates in Finl and have been made , prevalence rates are still substantial . Relapse rates among smokers engaged in quit-smoking programs are high . Physical activity has been proposed as one means to help smokers manage cravings . Software and apps on mobile phone and h and held devices offer an opportunity to communicate messages on how to use physical activity to manage cravings as part of quit-smoking programs . Objective We aim ed to test the feasibility , acceptability , usability , and preliminary efficacy of an mHealth mobile phone app , Physical activity over Smoking ( PhoS ) , to assist smokers in quitting smoking in a r and omized controlled trial . The app was design ed to prompt smokers to engage in physical activities to manage their smoking cravings . Methods Regular smokers ( n=44 ) attended a group-based behavioral counselling program aim ed at promoting physical activity as an additional aid to quit . After quit day , participants were r and omly allocated to an intervention ( n=25 ) or to a comparison ( n=19 ) group . Participants in the intervention group were provided with the PhoS app and training on how to use it to assist with relapse prevention . Participants in the comparison condition were provided with generalized relapse prevention training . Results Some participants reported that the PhoS app was useful in assisting them to successfully manage their cigarette cravings , although compliance across the sample was modest and participants reported low levels of usability . Participants receiving the PhoS app did not report greater abstinence than those who did not receive the app . However , participants receiving the app were more likely to report greater abstinence if they did not use pharmacological support , while those who did not receive the app reported greater abstinence when using pharmacological support . Participants receiving the app reported greater levels of physical activity than those who did not . Results revealed that the app result ed in better retention . Conclusions The PhoS app showed some potential to reduce abstinence among participants not using pharmacological therapy and to increase physical activity . However , problems with usability and lack of effects on abstinence raise questions over the app ’s long-term effectiveness . Future research should prioritize further development of the app to maximize usability and test effects of the intervention independent of quit-smoking programs . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 55259451 ; http://www.controlled-trials.com/IS RCT N55259451 ( Archived by WebCite at http://www.webcitation.org/6cKF2mzEI Introduction Smoking remains a major risk factor for chronic diseases . Health advice is considered one of the most cost-effective interventions ; however , changes produced by counseling tend not to persist over time , it is necessary to implement enforcement mechanisms . Methods R and omized clinical trial to evaluate the effectiveness of a combined program that includes health advice and text messaging to mobile phone ( SMSalud ® ) . Patients were r and omized to one of two interventions : health advice ( control group ) or health advice and text messaging ( intervention group ) . We included 320 smoker patients who met the inclusion criteria : being motivated , aged over 18 years , having a mobile phone , being able to read and send messages . Patients were excluded if they had a history of mental or behavioral disorders , or depression . The primary endpoint was the percentage of patients who had stopped smoking by 6 months and confirmed by CO breath test . Results By 6 months after the start of the program , 24.4 % ( 39/160 ) of patients in the intervention group and 11.9 % ( 19/160 ) of controls had stopped smoking ( OR : 2.3 ; 95 % CI : 1.3 - 4.3 , p = .007 ) . Patients with no dependence or mild dependence were more likely to stop ( 28.3 % , 36/127 vs. 11.4 % , 22/193 ; OR : 3.0 , 95 % CI : 1.7 - 5.5 , p < .001 ) . The rate of continuous abstinence at 12 months was 16.3 % ( 26/160 ) in intervention group patients and 5.6 % ( 9/160 ) in controls ( OR : 3.2 ; 95 % CI : 1.3 - 5.9 ) . ] . Conclusions The combined program is effective for smoking cessation . Patients with less tobacco dependence have a higher probability of success . Implication s Health advice is effective for promoting changes in lifestyle but these changes do not persist over time , so we have to use strengthening mechanisms , as e-health , and specifically , mobile phone based interventions . SMSalud ® is an innovate program that includes text messaging and health advice , and it 's effective for smoking cessation . The only feature that seems to affect the probability of smoking cessation is the degree of tobacco dependence Background Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment . We report three controlled trials of interventions to increase recruitment to the Txt2stop trial . Purpose To evaluate : Trial 1 . The impact on registration s of a text message regarding an online registration facility ; Trial 2 . The impact on r and omizations of sending £ 5 with a covering letter to those eligible to join the trial ; Trial 3 . The impact on r and omizations of text messages containing quotes from existing participants . Methods Single blind controlled trials with allocation concealment . Interventions : Trial 1 : A text message regarding our new online registration facility ; Trial 2 : A letter with £ 5 enclosed ; Trial 3 : A series of four text messages containing quotes from participants . The control group in each trial received st and ard Txt2stop procedures . Results Trial 1 : 3.6 % ( 17/470 ) of the intervention group and 1.1 % ( 5/467 ) of the control group registered for the trial , risk difference 2.5 % ( 95 % CI 0.6—4.5 ) . 0 % ( 0/ 470 ) of the intervention group and 0.2 % ( 1/467 ) of the control group registered successfully online , risk difference —0.2 ( 95 % CI —0.6—0.2 ) ; Trial 2 : 4.5 % ( 11/246 ) of the intervention group and 0.4 % ( 1/245 ) of the control group were r and omized into the Txt2stop trial , risk difference 4.0 % ( 95 % CI 1.4—6.7 ) ; Trial 3 : 3.5 % ( 14/405 ) of the intervention group and 0 % ( 0/406 ) of the control group were r and omized into the Txt2stop trial , risk difference 3.5 ( 95 % CI 1.7—5.2 ) . Limitations There were no baseline data available for trial 1 . Allocation of participant IDs in trials 2 and 3 were systematic . Conclusion Sending a text message about an online registration facility increased registration s to Txt2stop , but did not increase online registration s. Sending a £ 5 reimbursement for participants ’ time and sending text messages containing quotes from existing participants increased r and omizations into the Txt2stop trial . Clinical Trials 2010 ; 7 : 265—273 . Abstract Although adolescent tobacco use has declined in the last 10 years , African American high school seniors ’ past 30-day use has increased by 12 % , and as they age they are more likely to report lifetime use of tobacco . Very few urban youth are enrolled in evidence d-based smoking prevention and cessation programming . Therefore , we tested a text messaging smoking cessation intervention design ed to engage urban youth through an automated texting program utilizing motivational interviewing-based peer network counseling . We recruited 200 adolescents ( 90.5 % African American ) into a r and omized controlled trial that delivered either the experimental intervention of 30 personalized motivational interviewing-based peer network counseling messages , or the attention control intervention , consisting of text messages covering general ( non-smoking related ) health habits . All adolescents were provided smart phones for the study and were assessed at baseline , and at 1 , 3 , and 6 months post intervention . Utilizing repeated measures general linear models we examined the effects of the intervention while controlling for race , gender , age , presence of a smoker in the home , and mental health counseling . At 6 months , participants in the experimental condition significantly decreased the number of days they smoked cigarettes and the number of cigarettes they smoked per day ; they significantly increased their intentions not to smoke in the future ; and significantly increased peer social support among girls . For boys , participants in the experimental condition significantly reduced the number of close friends in their networks who smoke daily compared to those in the control condition . Effect sizes ranged from small to large . These results provide encouraging evidence of the efficacy of text messaging interventions to reduce smoking among adolescents and our intervention holds promise as a large-scale public health preventive intervention platform Hospitalization requires smokers to quit temporarily and offers healthcare professionals an opportunity to provide cessation treatment.1 However , it is important that encouragement continues after the patient has been discharged from the hospital.2 Studies have shown that text messaging interventions for smoking cessation are ef cacious in increasing biochemically con rmed cessation rates at 6-month follow-up.3 - 5 Utilizing technology such as automated voice calls postdischarge has been shown to increase smoking cessation rates ; however , text messaging has not been applied to this population .6 This r and omized controlled trial of automated smoking cessation support at discharge , coupled with brief advice among hospital in patients , aim ed to assess whether text messaging is a feasible method for providing smoking cessation support and monitoring smoking status postdischarge Background Emerging evidence supports the use of smartphone apps for smoking cessation , especially in young adults given their high smoking rates and high smartphone ownership rates . Although evaluative evidence is encouraging for supporting smoking cessation , there remains a paucity of research describing the design and development processes of mobile health ( mHealth ) interventions . Objective The aim of this paper was to describe the process of developing Crush the Crave ( CTC ) , an evidence -informed app to support smoking cessation in young adults , and the results of a formative evaluation of app usage behavior , as part of a broader program of research that seeks to establish the effectiveness of the CTC app . Methods The Spiral Technology Action Research ( STAR ) 5-cycle model ( listen , plan , do , act , and study ) was employed to guide the development , implementation , and dissemination of CTC . The approach to development and formative evaluation included focus groups with young adult smokers ( n=78 ) across 2 phases , analysis of the content of existing apps , 2 sessions with content experts , and Google Analytics to assess user behavior during a 12-month pilot . Results LISTEN — focus groups revealed young adult smoker preferences of ( 1 ) positive reinforcement , ( 2 ) personalization , ( 3 ) social support , ( 4 ) quit support , ( 5 ) tracking the behavior , and ( 6 ) tracking quit benefits . PLAN — informed by evidence for smoking cessation , young adult preferences and an assessment of popular cessation apps , content experts produced a mind map and a storyboard describing app content and structure . DO — focus groups with young adult smokers provided feedback on the first version of the app with opinions on content and suggestions for improvement such as providing alerts and distractions from craving . ACT — refinements were made , and app content was organized using the 4 key design components informed by principles of persuasive technology for behavior change : credibility , task support , dialogue support , and social support . CTC was launched in April 2013 and piloted from the period July 2013 to June 2014 where 1987 And roid users had 18,567 sessions , result ing in 59,384 page views and 89.58 % ( 1780/1987 ) of users returning within the same day to use CTC . STUDY —a pragmatic r and omized controlled trial of CTC was launched in August 2014 to demonstrate that including mHealth technology as a population -based intervention can help young adult smokers to quit . The results of this phase will be presented in a subsequent publication . Conclusions CTC is one of the first smoking cessation apps design ed to meet the needs of young adult smokers . The development was informed by the inclusion of young adults in the design and the systematic application of multiple stakeholder input , scientific evidence , and theory . The STAR model approach was followed from the beginning of intervention development , which should facilitate optimization of mHealth interventions in the future . Trial Registration Clinical Trials.gov NCT01983150 ; http:// clinical trials.gov/ct2/show/NCT01983150 ( Archived by WebCite at http://www.webcitation.org/6VGyc0W0i ABSTRACT Background : Text2Quit , an interactive text-messaging program aim ed at smoking cessation , has been shown to increase quit rates , but engagement has not been thoroughly explored . Underst and ing the program features associated with engagement and behavior change is integral for effective program design . Objectives : This study explored participants ’ interaction with the Text2Quit text-messaging program and associations between engagement and smoking cessation . Methods : The study included the 262 participants who received the Text2Quit intervention . Self-reported engagement measures , primarily usage of Text2Quit keywords and survey responses , were collected through computer records of participant use . Demographic variables and self-reported smoking abstinence were recorded in surveys at baseline and 6-month assessment . Results : The majority of participants ( 73 % ) maintained their subscription during the 6-month intervention . On average , participants received 210.51 text messages , 23.75 emails , and logged into the web portal 1.94 times . Being female was predictive of engagement with the program ( β = 15.39 ) . Program engagement , measured by the keyword PLEDGE ( p = .002 ) and the Smokefree Status at 7 Days survey ( p < .001 ) were associated with 6-month abstinence ; use of keywords SMOKED ( p < .001 ) , RELAPSE ( p = .007 ) , and STOP ( p = .023 ) were inversely related to abstinence . While abstainers ( N = 83 , 31 % ) stayed enrolled longer and engaged with the program more frequently , program “ dose ” was not predictive of smoking cessation . Conclusions : Using interactive tools such as pledges and reporting on smoking status were predictive of cessation . Further study of program features is required to underst and how to optimally design text messaging programs Abstract Aims To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service ( SMS ) text message and key parameters needed to plan a definitive trial . Design Multi‐centre , parallel‐group , single‐blinded , individual r and omized controlled trial . Setting Sixteen antenatal clinics in Engl and . Participants Four hundred and seven participants were r and omized to the intervention ( n = 203 ) or usual care ( n = 204 ) . Eligible women were < 25 weeks gestation , smoked at least one daily cigarette ( > 5 pre‐pregnancy ) , were able to receive and underst and English SMS texts and were not already using text‐based cessation support . Intervention All participants received a smoking cessation leaflet ; intervention participants also received a 12‐week programme of individually tailored , automated , interactive , self‐help smoking cessation text messages ( MiQuit ) . Outcome measurements Seven smoking outcomes , including vali date d continuous abstinence from 4 weeks post‐r and omization until 36 weeks gestation , design parameters for a future trial and cost‐per‐quitter . Findings Using the vali date d , continuous abstinence outcome , 5.4 % ( 11 of 203 ) of MiQuit participants were abstinent versus 2.0 % ( four of 204 ) of usual care participants [ odds ratio ( OR ) = 2.7 , 95 % confidence interval ( CI ) = 0.93–9.35 ] . The Bayes factor for this outcome was 2.23 . Completeness of follow‐up at 36 weeks gestation was similar in both groups ; provision of self‐report smoking data was 64 % ( MiQuit ) and 65 % ( usual care ) and abstinence validation rates were 56 % ( MiQuit ) and 61 % ( usual care ) . The incremental cost‐per‐quitter was £ 133.53 ( 95 % CI = –£395.78 to 843.62 ) . Conclusions There was some evidence , although not conclusive , that a text‐messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care AIMS To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention . DESIGN Two-arm r and omized control trial ( RCT ) . Setting World Wide Web ( WWW ) study based in Norway . PARTICIPANTS Subjects ( n = 396 ) were recruited via internet advertisements and assigned r and omly to conditions . Inclusion criteria were willingness to quit smoking and being aged 18 years or older . INTERVENTION The treatment group received the internet- and cell-phone-based Happy Ending intervention . The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail , web-pages , interactive voice response ( IVR ) and short message service ( SMS ) technology . The control group received a self-help booklet . Additionally , both groups were offered free nicotine replacement therapy ( NRT ) . MEASUREMENTS Abstinence was defined as ' not even a puff of smoke , for the last 7 days ' , and assessed by means of internet surveys or telephone interviews . The main outcome was repeated point abstinence at 1 , 3 , 6 and 12 months following cessation . FINDINGS Participants in the treatment group reported clinical ly and statistically significantly higher repeated point abstinence rates than control participants [ 22.3 % versus 13.1 % ; odds ratio ( OR ) = 1.91 , 95 % confidence interval ( CI ) : 1.12 - 3.26 , P = 0.02 ; intent-to-treat ) . Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group . CONCLUSIONS As the first RCT documenting the long-term treatment effects of such an intervention , this study adds to the promise of digital media in supporting behaviour change Background Mobile technology offers the potential to deliver health-related interventions to individuals who would not otherwise present for in-person treatment . Text messaging ( short message service , SMS ) , being the most ubiquitous form of mobile communication , is a promising method for reaching the most individuals . Objective The goal of the present study was to evaluate the feasibility and preliminary efficacy of a smoking cessation intervention program delivered through text messaging . Methods Adult participants ( N=60 , age range 18 - 52 years ) took part in a single individual smoking cessation counseling session , and were then r and omly assigned to receive either daily non-smoking related text messages ( control condition ) or the TXT-2-Quit ( TXT ) intervention . TXT consisted of automated smoking cessation messages tailored to individual ’s stage of smoking cessation , specialized messages provided on-dem and based on user requests for additional support , and a peer-to-peer social support network . Generalized estimating equation analysis was used to assess the primary outcome ( 7-day point-prevalence abstinence ) using a 2 ( treatment groups) × 3 ( time points ) repeated measures design across three time points : 8 weeks , 3 months , and 6 months . Results Smoking cessation results showed an overall significant group difference in 7-day point prevalence abstinence across all follow-up time points . Individuals given the TXT intervention , with higher odds of 7-day point prevalence abstinence for the TXT group compared to the Mojo group ( OR=4.52 , 95 % CI=1.24 , 16.53 ) . However , individual comparisons at each time point did not show significant between-group differences , likely due to reduced statistical power . Intervention feasibility was greatly improved by switching from traditional face-to-face recruitment methods ( 4.7 % yield ) to an online/remote strategy ( 41.7 % yield ) . Conclusions Although this study was design ed to develop and provide initial testing of the TXT-2-Quit system , these initial findings provide promising evidence that a text-based intervention can be successfully implemented with a diverse group of adult smokers . Trial Registration Clinical Trials.gov : NCT01166464 ; http:// clinical trials.gov/ct2/show/NCT01166464 ( Archived by WebCite at http://www.webcitation.org/6IOE8XdE0 ) Background Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation . To date , very few findings are available for primary care patients , and especially for the involvement of general practitioners . Objective Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting . Methods The study was an unblinded cluster-r and omized trial with an observation period of 12 weeks . Individuals recruited by general practitioners r and omized to the intervention group participated in a Web-based coaching program based on education , motivation , exercise guidance , daily short message service ( SMS ) reminding , weekly feedback through Internet , and active monitoring by general practitioners . All components of the program are fully automated . Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program . The main outcome was the biochemically confirmed smoking status after 12 weeks . Results We recruited 168 participants ( 86 intervention group , 82 control group ) into the study . For 51 participants from the intervention group and 70 participants from the control group , follow-up data were available both at baseline and 12 weeks . Very few patients ( 9.8 % , 5/51 ) from the intervention group and from the control group ( 8.6 % , 6/70 ) successfully managed smoking cessation ( OR 0.86 , 95 % CI 0.25 - 3.0 ; P=.816 ) . Similar results were found within the intent-to-treat analysis : 5.8 % ( 5/86 ) of the intervention group and 7.3 % ( 6/82 ) of the control group ( OR 1.28 , 95 % CI 0.38 - 4.36 ; P=.694 ) . The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group ( 2.7 mean difference ; 95 % CI -5.33 to -0.58 ; P=.045 ) . After adjustment for the baseline value , age , gender , and height , this significance decreases ( mean difference 2.2 ; 95 % CI -4.7 to 0.3 ; P=.080 ) . Conclusions This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care . The limited statistical power and the high drop-out rate may have reduced the study ’s ability to detect significant differences between the groups . Further r and omized controlled trials are needed in larger population s and to investigate the long-term outcome . Trial Registration German Register for Clinical Trials , registration number DRKS00003067 ; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL _ ID = DRKS00003067 ( Archived by WebCite at http://www.webcitation.org/6Sff1YZpx ) Introduction Weight gain and concerns about weight can influence a smoker 's ability to successfully quit , and young adults are a subgroup of smokers who are particularly concerned about the impact of quitting on their body weight . This study explored the associations between body mass index , weight perceptions , and smoking status among young adults . Methods The sample consisted of 4027 young adults between the ages of 18 and 29 who participated in a r and omized control trial of the National Cancer Institute 's SmokefreeTXT program . Multivariable logistic regression models were used to examine the associations between weight related variables and smoking status . Results Obese participants had a 0.72 lower odds ( 95 % CI : 0.62 , 0.85 ) of reporting smoking at the end of the program than participants of normal weight , and this difference persisted over time . Weight perceptions were also associated with smoking status . Those who perceived themselves to be slightly underweight/underweight were more likely to report smoking than those who reported being just about the right weight ( OR : 1.53 , 95 % CI : 1.20 , 1.95 ) , and those who strongly disagreed that smoking cigarettes helps people keep their weight down were less likely to report smoking at the end of treatment than those who neither agreed nor disagreed with this statement ( OR : 0.69 , 95 % CI : 0.54 , 0.87 ) . Conclusions Weight related factors assessed at baseline predicted smoking status at the end of treatment and through long term follow-up . Smoking cessation programs that tailor content to addresses the specific needs of weight concerned smokers may enhance effectiveness . Implication s This study explores the association between weight related factors and smoking status among young adults , a priority population for smoking cessation efforts . This study demonstrates that both actual weight and weight perceptions ( eg , perception of body weight , perception of associations between smoking and weight ) are associated with smoking outcomes , and thus need to be a considered in the development of smoking cessation programs Background Smoking tobacco is one of the most preventable causes of illness and death . Web-based tailored smoking cessation interventions have shown to be effective . Although these interventions have the potential to reach a large number of smokers , they often face high attrition rates , especially among lower educated smokers . A possible reason for the high attrition rates in the latter group is that computer-tailored smoking cessation interventions may not be attractive enough as they are mainly text-based . Video-based messages might be more effective in attracting attention and stimulating comprehension in people with a lower educational level and could therefore reduce attrition rates . Objective The objective of the present study was to investigate whether differences exist in message-processing mechanisms ( attention , comprehension , self-reference , appreciation , processing ) and future adherence ( intention to visit/use the website again , recommend the website to others ) , according to delivery strategy ( video or text based messages ) and educational level , to a Dutch computer-tailored smoking cessation program . Methods Smokers who were motivated to quit within the following 6 months and who were aged over 16 were included in the program . Participants were r and omly assigned to one of two conditions ( video/text CT ) . The sample was stratified into 2 categories : lower and higher educated participants . In total , 139 participants completed the first session of the web-based tailored intervention and were subsequently asked to fill out a question naire assessing message-processing mechanisms and future adherence . ANOVAs and regression analyses were conducted to investigate the differences in message-processing mechanisms and future adherence with regard to delivery strategy and education . Results No interaction effects were found between delivery strategy ( video vs text ) and educational level on message-processing mechanisms and future adherence . Delivery strategy had no effect on future adherence and processing mechanisms . However , in both groups results indicated that lower educated participants showed higher attention ( F 1,138=3.97 ; P=.05 ) and processing levels ( F 1,138=4.58 ; P=.04 ) . Results revealed also that lower educated participants were more inclined to visit the computer-tailored intervention website again ( F 1,138=4.43 ; P=.04 ) . Conclusions Computer-tailored programs have the potential to positively influence lower educated groups as they might be more involved in the computer-tailored intervention than higher educated smokers . Longitudinal studies with a larger sample are needed to gain more insight into the role of delivery strategy in tailored information and to investigate whether the intention to visit the intervention website again results in the ultimate goal of behavior change . Trial Registration Netherl and s Trial Register ( NTR3102 ) BACKGROUND This paper describes the development of an urban adolescent text messaging tobacco cessation intervention and preliminary findings from a r and omized , controlled trial . The authors successfully adapted a face-to-face intervention into a personalized , automated , and interactive 5-day texting protocol . METHODS Respondent-driven sampling was used beginning at a community substance abuse facility . Seventy-two tobacco-dependent adolescents were r and omized into an automated computer texting program that delivered either the experimental condition of 30 motivational interviewing- and social network counseling-based personalized messages or the attention control condition consisting of a texting program covering general ( non-smoking-related ) health habits . All teens were provided smartphones for the study and were assessed at baseline and at 1 , 3 , and 6 months post intervention . Analyses examined condition × time interactions . RESULTS At 6 months , the experimental condition decreased the number of cigarettes smoked in the past 30 days , increased intentions not to smoke in the future , and increased peer social support compared with controls . Effect sizes were moderate to large . CONCLUSIONS These findings are unique , as they target urban adolescents with a mobile health format and add to the growing literature on the efficacy of text-delivered interventions Background Loss to follow-up of trial participants represents a threat to research validity . To date , interventions design ed to increase participants ’ awareness of benefits to society of completing follow-up , and the impact of a telephone call from a senior female clinician and research er requesting follow-up have not been evaluated robustly . Purpose Trial 1 aim ed to evaluate the effect on trial follow-up of written information regarding the benefits of participation to society . Trial 2 aim ed to evaluate the effect on trial follow-up of a telephone call from a senior female clinician and research er . Methods Two single-blind r and omized controlled trials were nested within a larger trial , Txt2stop . In Trial 1 , participants were allocated using minimization to receive a refrigerator magnet and a text message emphasizing the benefits to society of completing follow-up , or to a control group receiving a simple reminder regarding follow-up . In Trial 2 , participants were r and omly allocated to receive a telephone call from a senior female clinician and research er , or to a control group receiving st and ard Txt2stop follow-up procedures . Results Trial 1 : 33.5 % ( 327 of 976 ) of the intervention group and 33.8 % ( 329 of 974 ) of the control group returned the question naire within 26 weeks of r and omization , risk ratio ( RR ) 0.99 ; 95 % confidence interval ( CI ) 0.88–1.12 . In all , 83.3 % ( 813 of 976 ) of the intervention group and 82.2 % ( 801 of/974 ) of the control group sent back the question naire within 30 weeks of r and omization , RR 1.01 ; 95 % CI 0.97 , 1.05 . Trial 2 : 31 % ( 20 of 65 ) of the intervention group and 32 % ( 20 of 62 ) of the control group completed trial follow-up , RR 0.93 ; 95%CI 0.44 , 1.98 . Conclusions In presence of other methods to increase follow-up neither experimental method ( refrigerator magnet and text message emphasizing participation 's benefits to society nor a telephone call from study 's principal investigator ) increased participant follow-up in the Txt2stop trial Objective To assess the efficacy of an interactive smoking cessation decision-aid application ( pp ) compared with a smoking cessation static information app on continuous abstinence . Design Automated double-blind r and omised controlled trial with 6 months follow-up ( 2014–2015 ) . Setting Smartphone-based . Participants 684 participants ( daily smokers of cigarettes , 18 years old or over ) recruited passively from app stores in the USA , Australia , UK and Singapore , and r and omised to one of two sub-apps . Intervention(s ) Behavioural , decision-aid , smartphone application . Main outcome ( s ) Continuous abstinence at 10 days , 1 month , 3 months and 6 months . Results Smokers who received the decision-aid app were more likely to be continuously abstinent at 1 month compared with the information-only app ( 28.5 % vs 16.9 % ; relative risk ( RR ) 1.68 ; 95 % CI 1.25 to 2.28 ) . The effect was sustained at 3 months ( 23.8 % vs 10.2 % ; RR 2.08 ; 95 % CI 1.38 to 3.18 ) and 6 months ( 10.2 % vs 4.8 % ; RR 2.02 ; 95 % CI 1.08 to 3.81 ) . Participants receiving the decision-aid app were also more likely to have made an informed choice ( 31.9 % vs 19.6 % ) and have lower decisional conflict ( 19.5 % vs 3.9 % ) . Conclusion A smartphone decision-aid app with support features significantly increased smoking cessation and informed choice . With an increasing number of smokers attempting to quit , unassisted evidence -based decision-aid apps can provide an effective and user-friendly option to many who are making quit decisions without healthcare professionals . Trial registration number ACTRN12613000833763 BACKGROUND Cigarette smoking among persons living with HIV ( PLWH ) is a pressing public health concern , and efforts to evaluate cessation treatments are needed . The purpose of the present study was to assess potential mechanisms of a cell phone-delivered intervention for HIV-positive smokers . METHODS Data from 350 PLWH enrolled in a r and omized smoking cessation treatment trial were utilized . Participants were r and omized to either usual care ( UC ) or a cell phone intervention ( CPI ) group . The independent variable of interest was treatment group membership , while the dependent variable of interest was smoking abstinence at a 3-month follow-up . The hypothesized treatment mechanisms were depression , anxiety , social support , quit motivation and self-efficacy change scores . RESULTS Abstinence rates in the UC and CPI groups were 4.7 % ( 8 of 172 ) and 15.7 % ( 28 of 178 ) , respectively . The CPI group ( vs. UC ) experienced a larger decline in depression between baseline and the 3-month follow-up , and a decline in anxiety . Self-efficacy increased for the CPI group and declined for the UC group . Quit motivation and social support change scores did not differ by treatment group . Only self-efficacy met the predefined criteria for mediation . The effect of the cell phone intervention on smoking abstinence through change in self-efficacy was statistically significant ( p<0.001 ) and accounted for 17 % of the total effect of the intervention on abstinence . CONCLUSIONS The findings further emphasize the important mechanistic function of self-efficacy in promoting smoking cessation for PLWH . Additional efforts are required to disentangle the relationships between emotional , distress motivation , and efficacious smoking cessation treatment The present trial examined the effectiveness of brief interventions for smokers who joined the Hong Kong Quit to Win Contest to quit smoking . A block r and omized controlled trial allocated 1003 adult daily smokers to three groups : ( i ) The TEL group ( n = 338 ) received a 5-min nurse-led telephone counselling ; ( ii ) The SMS group ( n = 335 ) received eight text messages through mobile phone and ( iii ) The CONTROL group ( n = 330 ) did not receive the above interventions . Participants with biochemically verified abstinence at 6-month follow-up could receive cash incentive . The primary outcome was the self-reported 7-day point prevalence ( PP ) of tobacco abstinence at 6-month follow-up . The abstinence rate in the TEL , SMS and CONTROL group was 22.2 , 20.6 and 20.3 % , respectively ( P for TEL versus CONTROL = 0.32 ; P for SMS versus CONTROL = 0.40 ) . When abstinence at 2- , 6- and 12-month follow-up was modelled simultaneously , the TEL group had a higher abstinence than the CONTROL group ( Adjusted OR = 1.38 , 95 % CI = 1.01 - 1.88 , P = 0 .04 ) . In the Quit to Win Contest , the brief telephone counselling might have increased abstinence , but the text messages had no significant effect . Further studies on intensive intervention and interactive messaging services are warranted Background Tobacco smoking prevalence continues to be high , particularly among adolescents and young adults with lower educational levels , and is therefore a serious public health problem . Tobacco smoking and problem drinking often co-occur and relapses after successful smoking cessation are often associated with alcohol use . This study aims at testing the efficacy of an integrated smoking cessation and alcohol intervention by comparing it to a smoking cessation only intervention for young people , delivered via the Internet and mobile phone . Methods / Design A two-arm cluster-r and omised controlled trial with one follow-up assessment after 6 months will be conducted . Participants in the integrated intervention group will : ( 1 ) receive individually tailored web-based feedback on their drinking behaviour based on age and gender norms , ( 2 ) receive individually tailored mobile phone text messages to promote drinking within low-risk limits over a 3-month period , ( 3 ) receive individually tailored mobile phone text messages to support smoking cessation for 3 months , and ( 4 ) be offered the option of registering for a more intensive program that provides strategies for smoking cessation centred around a self-defined quit date . Participants in the smoking cessation only intervention group will only receive components ( 3 ) and ( 4 ) . Study participants will be 1350 students who smoke tobacco daily/occasionally , from vocational schools in Switzerl and . Main outcome criteria are 7-day point prevalence smoking abstinence and cigarette consumption assessed at the 6-month follow up . Discussion This is the first study testing a fully automated intervention for smoking cessation that simultaneously addresses alcohol use and interrelations between tobacco and alcohol use . The integrated intervention can be easily implemented in various setting s and could be used with large groups of young people in a cost-effective way . Trial registration Current Controlled Trials IS RCT N02427446 ( date of registration : 08th September , 2014 ) Objectives : To determine the effectiveness of a mobile phone text messaging smoking cessation programme . Design : R and omised controlled trial Setting : New Zeal and Participants : 1705 smokers from throughout New Zeal and who wanted to quit , were aged over 15 years , and owned a mobile phone were r and omised to an intervention group that received regular , personalised text messages providing smoking cessation advice , support , and distraction , or to a control group . All participants received a free month of text messaging ; starting for the intervention group on their quit day to assist with quitting , and starting for the control group at six months to encourage follow up . Follow up data were available for 1624 ( 95 % ) at six weeks and 1265 ( 74 % ) at six months . Main outcome measures : The main trial outcome was current non-smoking ( that is , not smoking in the past week ) six weeks after r and omisation . Secondary outcomes included current non-smoking at 12 and 26 weeks . Results : More participants had quit at six weeks in the intervention compared to the control group : 239 ( 28 % ) v 109 ( 13 % ) , relative risk 2.20 ( 95 % confidence interval 1.79 to 2.70 ) , p < 0.0001 . This treatment effect was consistent across subgroups defined by age , sex , income level , or geographic location ( p homogeneity > 0.2 ) . The relative risk estimates were similar in sensitivity analyses adjusting for missing data and salivary cotinine verification tests . Reported quit rates remained high at six months , but there was some uncertainty about between group differences because of incomplete follow up . Conclusions : This programme offers potential for a new way to help young smokers to quit , being affordable , personalised , age appropriate , and not location dependent . Future research should test these findings in different setting s , and provide further assessment of long term quit rates Introduction : Smoking cessation support is increasingly delivered in primary care by auxiliary healthcare workers in place of healthcare professionals . However , it is unknown whether this shift might affect the quality and impact of the support delivered . Methods : Data from the iQuit in Practice r and omized control trial of cessation support in General Practice was used ( N = 602 ) . Analyses assessed whether cessation advisor type ( nurse or healthcare assistant [ HCA ] ) was associated with abstinence ( primary outcome : self-reported 2-week point prevalence abstinence at 8 weeks follow-up ) , the advice delivered during the initial consultation , pharmacotherapies prescribed , patient satisfaction , initial consultation length , and the number and type of interim contacts . Results : There were no statistically significant differences in abstinence for support delivered by HCAs versus nurses at 8 weeks ( HCAs 42.8 % , nurses 42.6 % ; unadjusted odds ratio [ OR ] = 1.01 , 95 % confidence interval [ CI ] = 0.73 to 1.40 ) , or at 4 weeks or 6 months follow-up . There were no statistically significant differences in advice delivered , the types of pharmacotherapies prescribed or patient satisfaction . Compared with nurses , HCA consultations were longer on average ( HCAs 23.6 minutes , nurses 20.8 minutes ; P = .002 ) and they undertook more interim contacts ( HCAs median 2 , nurses median 1 ; P < .001 ) , with contact more likely to be face-to-face than phone call ( HCAs 91.2 % , nurses 70.9 % ; OR = 4.23 , 95 % CI = 2.86 to 6.26 ) . Conclusions : HCAs appear equally effective as nurses in supporting smoking cessation , although they do this with greater patient contact . Using auxiliary practitioners to deliver cessation support could free up nurse time and reduce costs . Implication s : This study found that primary care patients receiving smoking cessation support from auxiliary healthcare workers were just as likely to be abstinent up to 6 months later as those patients seen by nurses . While the auxiliary healthcare workers achieved this with slightly increased patient contact time , the advice delivered , pharmacotherapies provided and patient satisfaction were similar to that of nurses . Exp and ing the auxiliary healthcare worker role to include smoking cessation support could increase role satisfaction and reduce the costs of cessation support delivery in primary care Summary Background Smoking cessation programmes delivered via mobile phone text messaging show increases in self-reported quitting in the short term . We assessed the effect of an automated smoking cessation programme delivered via mobile phone text messaging on continuous abstinence , which was biochemically verified at 6 months . Methods In this single-blind , r and omised trial , undertaken in the UK , smokers willing to make a quit attempt were r and omly allocated , using an independent telephone r and omisation system , to a mobile phone text messaging smoking cessation programme ( txt2stop ) , comprising motivational messages and behavioural-change support , or to a control group that received text messages unrelated to quitting . The system automatically generated intervention or control group texts according to the allocation . Outcome assessors were masked to treatment allocation . The primary outcome was self-reported continuous smoking abstinence , biochemically verified at 6 months . All analyses were by intention to treat . This study is registered , number IS RCT N 80978588 . Findings We assessed 11 914 participants for eligibility . 5800 participants were r and omised , of whom 2915 smokers were allocated to the txt2stop intervention and 2885 were allocated to the control group ; eight were excluded because they were r and omised more than once . Primary outcome data were available for 5524 ( 95 % ) participants . Biochemically verified continuous abstinence at 6 months was significantly increased in the txt2stop group ( 10·7 % txt2stop vs 4·9 % control , relative risk [ RR ] 2·20 , 95 % CI 1·80–2·68 ; p<0·0001 ) . Similar results were obtained when participants that were lost to follow-up were treated as smokers ( 268 [ 9 % ] of 2911 txt2stop vs 124 [ 4 % ] of 2881 control [ RR 2·14 , 95 % CI 1·74–2·63 ; p<0·0001 ] ) , and when they were excluded ( 268 [ 10 % ] of 2735 txt2stop vs 124 [ 4 % ] of 2789 control [ 2·20 , 1·79–2·71 ; p<0·0001 ] ) . No significant heterogeneity was shown in any of the prespecified subgroups . Interpretation The txt2stop smoking cessation programme significantly improved smoking cessation rates at 6 months and should be considered for inclusion in smoking cessation services . Funding UK Medical Research Council , Primary Care Research Networks Background Smoking in pregnancy is a public health problem . Self-help smoking cessation support can help pregnant women to stop smoking , but the effects of delivering this kind of support via SMS text message are not known . A previous r and omised controlled trial ( RCT ) demonstrated the feasibility and acceptability of providing such support to pregnant smokers using an automated , tailored text message intervention called MiQuit . This larger RCT will estimate key parameters for and will test the feasibility of delivering a major trial run within the United Kingdom National Health Service setting s aim ed at providing definitive evidence on the utility of MiQuit for helping pregnant smokers to stop . Methods / Design This will be a multi-centre , parallel group RCT . Participants are being identified in 16 English antenatal care setting s and must be > 16 years old , pregnant , < 25 weeks gestation , smoke > 1 daily cigarette , have smoked > 5 daily cigarettes before pregnancy , and able to underst and texts in English . After consenting and the collection of baseline data , participants are r and omised to control or intervention groups in a 1:1 ratio ; r and omisation is stratified by trial site and gestation and employs computer-generated pseudo-r and om code using r and om permuted blocks of r and omly varying size , and held on a secure server . All participants receive a National Health Service ( NHS ) leaflet aim ed at helping them to stop smoking . Intervention group women also receive the 12-week MiQuit programme of tailored , supportive , interactive text message , self-help cessation support . Women are followed up by telephone 4 weeks after r and omisation and at 36 weeks gestation . The study aims to recruit 400 women , and with this sample we will be able to estimate trial centres ’ recruitment rates to within + /−1 % ( margin of error = half width of 95 % confidence interval ) ; individual trial groups ’ ascertainment of rates for smoking outcomes between 4 weeks after r and omisation until approximately 36 weeks gestation to within + /−4 % , and across both groups , the combined cessation rate at 36 weeks + /−3 % . Discussion Pilot trial completion will provide data to facilitate planning for a definitive trial investigating whether MiQuit works for smoking cessation in pregnancy . Trial registration Clinical Trials.gov NCT02043509 Registered 14 January 2014 Background Primary care is an important setting for smoking cessation interventions . There is evidence for the effectiveness of tailored interventions for smoking cessation , and text messaging interventions for smoking cessation show promise . The intervention to be evaluated in this trial consists of two components : ( 1 ) a web-based program design ed to be used by a practice nurse or other smoking cessation advisor ( SCA ) ; the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker ; and ( 2 ) a three-month programme of automated tailored text messages sent to the smoker ’s mobile phone . The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone . Methods / design The design is a two parallel group r and omised controlled trial ( RCT ) . 600 smokers who want to quit will be recruited in up to 30 general practice s in the East of Engl and . During a consultation with an SCA , they will be individually r and omised by computer program to usual care ( Control ) or to usual care plus the iQuit system ( Intervention ) . At the four-week follow-up appointment , the SCA will record smoking status and measure carbon monoxide level . There will be two further follow-ups , at eight weeks and six months from r and omisation date , by postal question naire sent from and returned to the study centre or by telephone interview conducted by a research interviewer . The primary outcome will be self-reported abstinence for at least two weeks at eight weeks . A sample size of 300 per group would give 80 % power to detect an increase in quit rate from 20 % to 30 % ( alpha = 0.05 , 2-sided test ) . The main analyses of quit rates will be conducted on an intention-to-treat basis , making the usual assumption that participants lost to follow up are smoking . Discussion This trial will focus on acceptability , feasibility and short-term effectiveness . The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness . Trial registration IS RCT Background Tobacco consumption is the most preventable cause of morbidity-mortality in the world . One aspect of smoking cessation that merits in-depth study is the use of an application design ed for smartphones ( app ) , as a supportive element that could assist younger smokers in their efforts to quit . To assess the efficacy of an intervention that includes the assistance of a smoking cessation smartphone application targeted to young people aged 18 to 30 years who are motivated to stop smoking . Methods / design Cluster r and omised clinical trial . Setting : Primary Health Care centres ( PHCCs ) in Catalonia . Analyses based on intention to treat . Participants : motivated smokers of 10 or more cigarettes per day , aged 18 to 30 years , consulting PHCCs for any reason and who provide written informed consent to participate in the trial . Intervention group will receive a 6-month smoking cessation programme that implements recommendations of a Clinical Practice Guideline , complemented with a smartphone app design ed specifically for this programme . Control group will receive the usual care . The outcome measure will be abstinence at 12 months confirmed by exhaled-air carbon monoxide concentration of at least 10 parts per million at each control test . Discussion To our knowledge this is the first r and omised controlled trial of a programme comparing the efficacy of usual care with a smoking cessation intervention involving a mobile app . If effective , the modality could offer a universal public health management approach to this common health concern . Trial registration Purpose . To assess the feasibility , acceptability , and efficacy of a text message – based smoking cessation intervention in China . Design . Study design was a r and omized control trial with a 6-month follow-up assessment of smoking status . Setting . Zhejiang , Heilongjiang , and Shaanxi provinces in China provided the study setting . Subjects . A total of 8000 adult smokers in China who used Nokia Life Tools and participated in phase 2 ( smoking education via text message ) of the study were included . Intervention . The high-frequency text contact ( HFTC ) group received one to three messages daily containing smoking cessation advice , encouragement , and health education information . The low-frequency text contact ( LFTC ) group received one weekly message with smoking health effects information . Measures . Our primary outcome was smoking status at 0 , 1 , 3 , and 6 months after intervention . Secondary outcomes include participant perceptions of the HFTC intervention , and factors associated with smoking cessation among HFTC participants . Analysis . Descriptive and χ2 analyses were conducted to assess smoking status and acceptability . Factors associated with quitting were assessed using multiple logistic regression analyses . Results . Quit rates were high in both the HFTC and LFTC groups ( HFTC : 0 month , 27.9 % ; 1 month , 30.5 % ; 3 months , 26.7 % ; and 6 months , 27.7 % ; LFTC : 0 month , 26.7 % ; 1 month , 30.4 % ; 3 months , 28.1 % ; and 6 months , 27.7 % ) , with no significant difference between the two groups in an intent-to-treat analysis . Attitudes toward the HFTC intervention were largely positive . Conclusion . Our findings suggest that a text message – based smoking cessation intervention can be successfully delivered in China and is acceptable to Chinese smokers , but further research is needed to assess the potential impact of this type of intervention Background Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide . In North America , smoking rates are highest among young adults . Despite that the majority of young adult smokers indicate wanting to quit , smoking rates among this age demographic have yet to decline . Helping young adults quit smoking continues to be a public health priority . Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions , especially because young adults are the heaviest users of this technology . Objective The primary aim of this trial is to determine the effectiveness of an evidence -informed mobile phone app for smoking cessation , Crush the Crave , on reducing smoking prevalence among young adult smokers . Methods A parallel r and omized controlled trial ( RCT ) with two arms will be conducted in Canada to evaluate Crush the Crave . In total , 1354 young adult smokers ( 19 to 29 years old ) will be r and omized to receive the evidence -informed mobile phone app , Crush the Crave , or an evidence -based self-help guide known as “ On the Road to Quitting ” ( control ) for a period of 6 months . The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up . Secondary outcomes include a 7-day point prevalence of abstinence , number of quit attempts , reduction in consumption of cigarettes , self-efficacy , satisfaction , app utilization metrics , and use of smoking cessation services . A cost-effectiveness analysis is included . Results This trial is currently open for recruitment . The anticipated completion date for the study is April 2016 . Conclusions This r and omized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers . Evidence from the trial will also inform the development of future apps , provide a deeper underst and ing of the factors that drive change in smoking behavior using an app , and improve the design of cessation apps . This trial is among the first to assess the effect of a comprehensive and evidence -informed mHealth smoking cessation app on a large sample of young adult smokers . Strengths of the trial include the high- quality research design and in-depth assessment of the implementation of the intervention . If effective , the trial has the potential to demonstrate that including mHealth technology as a population -based intervention strategy can cost-effectively reach a greater proportion of the population and help young adult smokers to quit . Trial Registration Clinical Trials.gov NCT01983150 ; http:// clinical trials.gov/ct2/show/NCT01983150 ( Archived by WebCite at http://www.webcitation.org/6VGyc0W0i ) Background Smoking prevalence remains high , particularly among adolescents and young adults with lower educational levels , posing a serious public health problem . There is limited evidence of effective smoking cessation interventions in this population . Objective To test the efficacy of an individually tailored , fully automated text messaging ( short message service , SMS)–based intervention for smoking cessation in young people . Methods A 2-arm cluster r and omized controlled trial , using school class as the r and omization unit , was conducted to test the efficacy of the SMS text messaging intervention compared to an assessment -only control group . Students who smoked were proactively recruited via online screening in vocational school classes . Text messages , tailored to demographic and smoking-related variables , were sent to the participants of the intervention group at least 3 times per week over a period of 3 months . A follow-up assessment was performed 6 months after study inclusion . The primary outcome measure was 7-day smoking abstinence . Secondary outcomes were 4-week smoking abstinence , cigarette consumption , stage of change , and attempts to quit smoking . We used regression models controlling for baseline differences between the study groups to test the efficacy of the intervention . Both complete-case analyses ( CCA ) and intention-to-treat analyses ( ITT ) were performed . Subgroup analyses were conducted for occasional and daily smokers . Results A total of 2638 students in 178 vocational school classes in Switzerl and participated in the online screening . Overall , 1012 persons met the inclusion criteria for study participation , and 755 persons ( 74.6 % ) participated in the study ( intervention : n=372 ; control : n=383 ) . Of the 372 program participants , 9 ( 2.4 % ) unsubscribed from the program during the intervention period . Six-month follow-up data were obtained for 559 study participants ( 74.0 % ) . The 7-day smoking abstinence rate at follow-up was 12.5 % in the intervention group and 9.6 % in the control group ( ITT : P=.92 ) . No differences between the study groups were observed in 4-week point prevalence abstinence rates . The decrease in the mean number of cigarettes smoked per day from baseline to follow-up was higher in the intervention group than in the control group ( ITT : P=.002 ) . No differences between the groups were observed in stage of change ( ITT : P=.82 ) and quit attempts ( ITT : P=.38 ) . The subgroup analyses revealed lower cigarette consumption in both occasional and daily smokers in the intervention group compared to the control group . Occasional smokers in the intervention group made more attempts to quit smoking than occasional smokers in the control group . Conclusions This study demonstrated the potential of an SMS text message – based intervention to reach a high proportion of young smokers with low education levels . The intervention did not have statistically significant short-term effects on smoking cessation ; however , it result ed in statistically significant lower cigarette consumption . Additionally , it result ed in statistically significant more attempts to quit smoking in occasional smokers . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 19739792 ; http://www.controlled-trials.com/IS RCT N19739792 ( Archived by WebCite at http://webcitation.org/6IGETTHmr ) Introduction In a previous study exploring the feasibility of a smoking cessation application ( app ) , we found that about 77 % of the respondents from three countries were ready to quit in the next 30 days without significant differences between countries in terms of age , operating system and number of quitting attempts . However , the efficacy of smartphone apps for smoking cessation has not yet been established . This study tests the efficacy of a smartphone smoking cessation decision-aid app compared with an app that contains only smoking cessation information . Methods and analysis This is an automated double-blind , r and omised controlled trial of a smoking cessation app that contains the eligibility requirements and baseline question naire and will r and omise the participants into one of the two subapps ( the intervention and the control ) . Participants will be recruited directly from the Apple app stores in Australia , Singapore , the UK and the USA . Daily smokers aged 18 and above will be r and omised into one of the subapps after completing the baseline question naire . Abstinence rates will be measured at 10 days , 1 month , 3 months and 6 months , with the 1-month follow-up abstinence rate as the primary outcome . Logistic regression mixed models will be used to analyse the primary outcome . Ethics and dissemination This study was approved by the University of Sydney 's Human Ethics Committee . The results of the trial will be published in peer- review ed journals according to the CONSORT statement . Trial registration number Australian New Zeal and Clinical Trial RegistryACTRN12613000833763 Introduction A French national smoking cessation service , Tabac Info Service , has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts ( eg , question naires , advice , activities , messages ) to support smoking cessation . This paper presents the study protocol of the evaluation of the application ( e-intervention Tabac Info Service ( e-TIS ) ) . The primary objective is to assess the efficacy of e-TIS . The secondary objectives are to ( 1 ) describe efficacy variations with regard to users ' characteristics , ( 2 ) analyse mechanisms and context ual conditions of e-TIS efficacy . Methods and analyses The study design is a two-arm pragmatic r and omised controlled trial including a process evaluation with at least 3000 participants r and omised to the intervention or to the control arm ( current practice s ) . Inclusion criteria are : aged 18 years or over , current smoker , having completed the online consent forms , possessing a mobile phone with and roid or apple systems and using mobile applications , wanting to stop smoking sooner or later . The primary outcome is the point prevalence abstinence of 7 days at 6 months later . Data will be analysed in intention to treat ( primary ) and per protocol analyses . A logistic regression will be carried out to estimate an OR ( 95 % CI ) for efficacy . A multivariate multilevel analysis will explore the influence on results of patients ' characteristics ( sex , age , education and socioprofessional levels , dependency , motivation , quit experiences ) and context ual factors , conditions of use , behaviour change techniques . Ethics and dissemination The study protocol was review ed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016 . The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy . These findings will be disseminated through peer- review ed articles . Trial registration number NCT02841683 ; Pre- results Introduction Smoking is the largest cause of preventable death globally . Most smokers smoke their first cigarette in early adolescence . We took advantage of the widespread availability of mobile phones and adolescents ’ interest in appearance to develop a free photoaging app which is promoted via a poster campaign in secondary schools . This study aims to evaluate its effectiveness regarding smoking prevalence and students ’ attitudes towards smoking . Methods and analysis A r and omised controlled trial is conducted with 9851 students of both genders with an average age of 12 years in grade s 6 and 7 of 126 secondary schools in Germany . At present , cigarette smoking prevalence in our sample is 4.7 % , with 4.6 % of the students currently using e-cigarettes ( 1.6 % use both ) . The prospect i ve experimental study design includes measurements at baseline and at 6 , 12 and 24 months postintervention via a question naire plus a r and om cotinine saliva sample at 24 months postintervention . The study groups consist of r and omised schools receiving the Smokerface poster campaign and control schools with comparable baseline data ( no intervention ) . The primary end point is the difference of change in smoking prevalence in the intervention group versus the difference in the control group at 24 months follow-up . Longitudinal changes in smoking-related attitudes , the number of new smokers and quitters and the change in the number of never-smokers will be compared between the two groups as secondary outcomes . Ethics and dissemination Ethical approval was obtained from the ethics committee of the University of Gießen and the ministries of cultural affairs , both in Germany . Results will be disseminated at conferences , in peer- review ed journals , on our websites and throughout the multinational Education Against Tobacco network . Trial registration number NCT02544360 , Pre- results The aim was to better underst and structural factors associated with uptake of automated tailored interventions for smoking cessation . In a prospect i ve r and omized controlled trial with interventions only offered , not m and ated , participants were r and omized based on the following : web-based expert system ( QuitCoach ) ; text messaging program ( onQ ) ; both as an integrated package ; the choice of using either or both ; or a control condition informed of a static website ( not considered here ) . Participants were 3530 smokers or recent quitters recruited from two sources ; those seeking smoking cessation information , mostly recruited over the phone , and a cold-contacted group recruited from an Internet panel . More participants ( 60.1 % ) initially accepted the intervention they had been offered than used it ( 42.5 % ) . Uptake of each intervention differed substantially by both recruitment source and modality ( phone or web ) . onQ was a little more popular overall , especially in the information seeker sample . Highest overall intervention uptake occurred in the choice condition . A web-based intervention is most attractive if the offer to use is made by web , whereas a phone-based intervention is more likely to be used if the offer is made over the phone . Providing automated interventions on multiple platforms allows for maximal choice and greatest overall use of some form of help Background A wide range of effective smoking cessation interventions have been developed to help smokers to quit . Smoking rates remain high , especially among people with a lower level of education . Multiple tailoring adapted to the individual ’s readiness to quit and the use of visual messaging may increase smoking cessation . Objective The results of video and text computer tailoring were compared with the results of a control condition . Main effects and differential effects for subgroups with different educational levels and different levels of readiness to quit were assessed . Methods During a blind r and omized controlled trial , smokers willing to quit within 6 months were assigned to a video computer tailoring group with video messages ( n=670 ) , a text computer tailoring group with text messages ( n=708 ) , or to a control condition with short generic text advice ( n=721 ) . After 6 months , effects on 7-day point prevalence abstinence and prolonged abstinence were assessed using logistic regression analyses . Analyses were conducted in 2 sample s : ( 1 ) respondents ( as r and omly assigned ) who filled in the baseline question naire and completed the first session of the program , and ( 2 ) a sub sample of sample 1 , excluding respondents who did not adhere to at least one further intervention session . In primary analyses , we used a negative scenario in which respondents lost to follow-up were classified as smokers . Complete case analysis and multiple imputation analyses were considered as secondary analyses . Results In sample 1 , the negative scenario analyses revealed that video computer tailoring was more effective in increasing 7-day point prevalence abstinence than the control condition ( OR 1.45 , 95 % CI 1.09 - 1.94 , P=.01 ) . Video computer tailoring also result ed in significantly higher prolonged abstinence rates than controls among smokers with a low ( ready to quit within 4 - 6 months ) readiness to quit ( OR 5.13 , 95 % CI 1.76 - 14.92 , P=.003 ) . Analyses of sample 2 showed similar results , although text computer tailoring was also more effective than control in realizing 7-day point prevalence abstinence . No differential effects were found for level of education . Complete case analyses and multiple imputation yielded similar results . Conclusions In all analyses , video computer tailoring was effective in realizing smoking cessation . Furthermore , video computer tailoring was especially successful for smokers with a low readiness to quit smoking . Text computer tailoring was only effective for sample 2 . Results suggest that video-based messages with personalized feedback adapted to the smoker ’s motivation to quit might be effective in increasing abstinence rates for smokers with diverse educational levels . Trial Registration Netherl and s Trial Register : NTR3102 ; http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=3102 ( Archived by WebCite at http://www.webcitation.org/6NS8xhzUV ) Introduction Millions of smokers use the Internet for smoking cessation assistance each year ; however , most smokers engage minimally with even the best design ed websites . The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions . Text messaging is used by most adults , and messages can proactively encourage use of a web-based intervention . Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components . Methods and analysis We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme : personalisation , integration , dynamic tailoring and message intensity . Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention . The primary outcome is a composite metric of adherence that incorporates general utilisation metrics ( eg , logins , page views ) and specific feature utilisation shown to predict abstinence . Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme . Phase II will be a two-arm r and omised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months . Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging . Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome . Ethics and dissemination This protocol was approved by Chesapeake IRB . We will disseminate study results through peer- review ed manuscripts and conference presentations related to the methods and design , outcomes and exploratory analyses . Trial registration number NCT02585206 Background Addressing children ’s tobacco smoke exposure ( TSE ) remains a public health priority . However , there is low uptake and ineffectiveness of treatment , particularly in low-income population s that face numerous challenges to smoking behavior change . A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women , Infants and Children ( WIC ) , combined with nicotine replacement and intensive multimodal , individual-level behavioral intervention may improve TSE control efforts in such high-risk population s. Methods / Design This trial uses a r and omized two-group design with three measurement points : baseline , 3-month and 12-month follow-up . The primary outcome is bioverified child TSE ; the secondary outcome is bioverified maternal quit status . Smoking mothers of children less than 6 years old are recruited from WIC clinics . All participants receive WIC system-level intervention based on the “ Ask , Advise , Refer ( AAR ) ” best practice s guidelines for pediatrics clinics . It includes training all WIC staff about the importance of maternal tobacco control ; and detailing clinics with AAR intervention prompts in routine work flow to remind WIC nutrition counselors to ask all mothers about child TSE , advise about TSE harms and benefits of protection , and refer smokers to cessation services . After receiving the system intervention , mothers are r and omized to receive 3 months of additional treatment or an attention control intervention : ( 1 ) The multimodal behavioral intervention ( MBI ) treatment includes telephone counseling sessions about child TSE reduction and smoking cessation , provision of nicotine replacement therapy , a mobile app to support cessation efforts , and multimedia text messages about TSE and smoking cessation ; ( 2 ) The attention control intervention offers equivalent contact as the MBI and includes nutrition-focused telephone counseling , mobile app , and multimedia text messages about improving nutrition . The control condition also receives a referral to the state smoking cessation quitline . Discussion This study tests an innovative community-based , multilevel and integrated multimodal approach to reducing child TSE in a vulnerable , low-income population . The approach is sustainable and has potential for wide reach because WIC can integrate the tobacco intervention prompts into routine workflow and refer smokers to free evidence -based behavioral counseling interventions , such as state quitlines . Trial registration Clinical trials.gov NCT02602288 . Registered 9 November 2015 Background Particularly in groups of adolescents with lower educational level the smoking prevalence is still high and constitutes a serious public health problem . There is limited evidence of effective smoking cessation interventions in this group . Individualised text messaging ( SMS ) based interventions are promising to support smoking cessation and could be provided to adolescents irrespective of their motivation to quit . The aim of the current paper is to outline the study protocol of a trial testing the efficacy of an SMS based intervention for smoking cessation in apprentices . Methods / Design A two-arm cluster-r and omised controlled trial will be conducted to test the efficacy of an SMS intervention for smoking cessation in adolescents and young adults compared to an assessment only control group . A total of 910 daily or occasional ( ≥ 4 cigarettes in the preceding month and ≥ 1 cigarette in the preceding week ) smoking apprentices will be proactively recruited in vocational school classes and , using school class as a r and omisation unit , r and omly assigned to an intervention group ( n = 455 ) receiving the SMS based intervention or an assessment only control group ( n = 455 ) . Individualised text messages taking into account demographic data and the individuals ' smoking behaviours will be sent to the participants of the intervention group over a period of 3 months . Participants will receive two text messages promoting smoking cessation per week . Program participants who intend to quit smoking have the opportunity to use a more intensive SMS program to prepare for their quit day and to prevent a subsequent relapse . The primary outcome measure will be the proportion of participants with 7-day point prevalence smoking abstinence assessed at 6-months follow-up . The research assistants conducting the baseline and the follow-up assessment s will be blinded regarding group assignment . Discussion It is expected that the program offers an effective and inexpensive way to promote smoking cessation among adolescents and young adults including those with lower educational level and independent of their motivation to quit . Trial registration numberIS RCT N : IS RCT Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry : BACKGROUND People living with human immunodeficiency virus (HIV)/AIDS ( PLWHA ) have a substantially higher prevalence of cigarette smoking compared to the general population . In addition , PLWHA are particularly susceptible to the adverse health effects of smoking . Our primary objective was to design and test the efficacy over 12 months of a smoking cessation intervention targeting PLWHA . METHODS Participants were enrolled from an urban HIV clinic with a multiethnic and economically disadvantaged patient population . Participants received smoking cessation treatment either through usual care ( UC ) or counseling delivered by a cell phone intervention ( CPI ) . The 7-day point prevalence abstinence was evaluated at 3 , 6 , and 12 months using logistic regression and generalized linear mixed models . RESULTS We r and omized 474 HIV-positive smokers to either the UC or CPI group . When evaluating the overall treatment effect ( 7-day abstinence outcomes from 3- , 6- , and 12-month follow-ups ) , participants in the CPI group were 2.41 times ( P = .049 ) more likely to demonstrate abstinence compared to the UC group . The treatment effect was strongest at the 3-month follow-up ( odds ratio = 4.3 , P < .001 ) , but diminished at 6 and 12 months ( P > .05 ) . CONCLUSIONS Cell phone-delivered smoking cessation treatment has a positive impact on abstinence rates compared to a usual care approach . Future research should focus on strategies for sustaining the treatment effect in the long term The main objective of this paper is to present a new program that facilitates the management of people who want to quit smoking , implemented through an e-treatment software called S-PC ( Smoker Patient Control ) . S-PC is a web-based application that manages groups of patients , provides a bidirectional communication through mobile text messages and e-mails between patients and clinicians and offers advice and control to keep track of the patients and their status . A total of 229 patients were enrolled in the study , r and omly divided into two groups , although some variables were tested to ensure that there were no significant differences between the groups that could have an impact on the outcome of the treatment . There were no significant differences between the two groups regarding the ratio/number of males/females , tobacco dependence , co-oximetry , average cigarette consumption , current age and age when smoking started . The first group was made up of 104 patients ( 45.4 % of the total ) and followed a treatment that incorporated the S-PC tool , while the second one had 125 patients without the S-PC tool . S-PC was evaluated for its effectiveness at assisting the patients to give up smoking , and its effect on clinician time management . 74 % of the S-PC group completed the treatment without relapses and remained abstinent three months after the completion of the treatment , underst and ing abstinence as being continuous ( with no relapses allowed and co-oximetry below 1 ppm ) from the day of stopping . In contrast only 45.6 % of the No S-PC group completed the treatment without relapses and remained abstinent three months after completion of the treatment . The rate of admittance to the program has doubled in one year and patients went from having to wait for 3 months to be immediately admitted into the program . This therapeutic e-health program aims at maximizing the number of patients that a professional can effectively help to quit smoking . In addition , the system also detects patients who are not progressing appropriately , allowing the professional to improve their treatment parameters dynamically BACKGROUND There is a dual need for ( 1 ) innovative theory-based smartphone applications for smoking cessation and ( 2 ) controlled trials to evaluate their efficacy . Accordingly , this study tested the feasibility , acceptability , preliminary efficacy , and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy ( ACT ) application for smoking cessation vs. an application following US Clinical Practice Guidelines . METHOD Adult participants were recruited nationally into the double-blind r and omized controlled pilot trial ( n=196 ) that compared smartphone-delivered ACT for smoking cessation application ( SmartQuit ) with the National Cancer Institute 's application for smoking cessation ( QuitGuide ) . RESULTS We recruited 196 participants in two months . SmartQuit participants opened their application an average of 37.2 times , as compared to 15.2 times for QuitGuide participants ( p<0001 ) . The overall quit rates were 13 % in SmartQuit vs. 8 % in QuitGuide ( OR=2.7 ; 95 % CI=0.8 - 10.3 ) . Consistent with ACT 's theory of change , among those scoring low ( below the median ) on acceptance of cravings at baseline ( n=88 ) , the quit rates were 15 % in SmartQuit vs. 8 % in QuitGuide ( OR=2.9 ; 95 % CI=0.6 - 20.7 ) . CONCLUSIONS ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines . As results were limited by the pilot design ( e.g. , small sample ) , a full-scale efficacy trial is now needed Abstract Background : Currently , there are over 400 smoking cessation smartphone apps available , downloaded an estimated 780,000 times per month . No prior studies have examined how individuals engage with specific features of cessation apps and whether use of these features is associated with quitting . Objectives : Using data from a pilot trial of a novel smoking cessation app , we examined : ( i ) the 10 most-used app features , and ( ii ) prospect i ve associations between feature usage and quitting . Methods : Participants ( n = 76 ) were from the experimental arm of a r and omized , controlled pilot trial of an app for smoking cessation called “ SmartQuit , ” which includes elements of both Acceptance and Commitment Therapy ( ACT ) and traditional cognitive behavioral therapy ( CBT ) . Utilization data were automatically tracked during the 8-week treatment phase . Thirty-day point prevalence smoking abstinence was assessed at 60-day follow-up . Results : The most-used features – quit plan , tracking , progress , and sharing – were mostly CBT . Only two of the 10 most-used features were prospect ively associated with quitting : viewing the quit plan ( p = 0.03 ) and tracking practice of letting urges pass ( p = 0.03 ) . Tracking ACT skill practice was used by fewer participants ( n = 43 ) but was associated with cessation ( p = 0.01 ) . Conclusions : In this exploratory analysis without control for multiple comparisons , viewing a quit plan ( CBT ) as well as tracking practice of letting urges pass ( ACT ) were both appealing to app users and associated with successful quitting . Aside from these features , there was little overlap between a feature ’s popularity and its prospect i ve association with quitting . Tests of causal associations between feature usage and smoking cessation are now needed Mobile-phone-based smoking cessation intervention has been shown to increase quitting among smokers . However , such intervention has not yet been applied to secondh and smoke ( SHS ) reduction programs that target smoking parents of newborns . This r and omized controlled trial , undertaken in Changchun , China , assessed whether interventions that incorporate traditional and mobile-phone-based education will help create smoke-free homes for infants and increase quitting among fathers . The results showed that the abstinence rates of the fathers at 6 months ( adjusted OR : 3.60 , 95 % CI : 1.41–9.25 ; p = 0.008 ) and 12 months ( adjusted OR : 2.93 , 95 % CI : 1.24–6.94 ; p = 0.014 ) were both significantly increased in the intervention group compared to the control . Mothers of the newborns in the intervention group also reported reduced exposure to SHS at 12 months ( adjusted OR : 0.53 , 95 % CI : 0.29–0.99 ; p = 0.046 ) . The findings suggest that adding mHealth interventions to traditional face-to-face health counseling may be an effective way to increase male smoking cessation and reduce mother and newborn SHS exposure in the home INTRODUCTION Poly-tobacco use is defined as cigarette and other tobacco consumption with either product used daily or nondaily . While concurrent use of different types of tobacco has been documented within the general population , less is known about poly-tobacco use among HIV-positive smokers and its impact on smoking cessation efforts . OBJECTIVE To characterize the profile of poly-tobacco users ( PTU ) in a sample of HIV-positive smokers participating in a cessation program . METHODS The study sample consisted of 474 HIV-positive smokers enrolled in a 2-group r and omized controlled trial of cigarette smoking cessation comparing a cell phone-based intervention to usual care . Prevalence was determined , and risk factors for poly-tobacco use were evaluated using logistic regression . RESULTS In this cohort of HIV-positive cigarette smokers , 21.6 % of participants were PTU , with cigars ( 73.4 % ) the most common tobacco product consumed . Among PTU , 73.5 % used other form(s ) of tobacco some days , and 26.5 % use them every day . Perceived discrimination and unemployment were significantly associated with poly-tobacco use after adjusting for other demographic , behavioral , and psychosocial factors . Analysis showed that participants in the cell phone group ( vs. usual care ) were more likely to report 24-hr abstinence , both among monocigarette users ( 16.6 % vs. 6.3 % , p < .001 ) and PTU ( 18.5 % vs. 0 % , p < .001 ) . CONCLUSION Poly-tobacco use prevalence among adult HIV-positive smokers was considerably higher than in the general population . Special attention must be placed on concurrent use of cigarettes and cigars among HIV-positive smokers . Because PTU are a unique population less likely to succeed in brief smoking cessation interventions , effective cessation programs are needed Aims To estimate the short-term effectiveness , feasibility and acceptability of a smoking cessation intervention ( the iQuit system ) that consists of tailored printed and Short Message Service ( SMS ) text message self-help delivered as an adjunct to cessation support in primary care to inform the design of a definitive trial . Design A stratified two parallel-group r and omized controlled trial comparing usual care ( control ) with usual care plus the iQuit system ( intervention ) , delivered by primary care nurses/healthcare assistants who were blinded to the allocation sequence . Setting Thirty-two general practice ( GP ) surgeries in Engl and , UK . Participants A total of 602 smokers initiating smoking cessation support from their local GP surgery were r and omized ( control n = 303 , intervention n = 299 ) . Measurements Primary outcome was self-reported 2-week point prevalence abstinence at 8 weeks follow-up . Secondary smoking outcomes and feasibility and acceptability measures were collected at 4 weeks after quit date , 8 weeks and 6 months follow-up . Findings There were no significant between-group differences in the primary outcome [ control 40.3 % , iQuit 45.2 % ; odds ratio ( OR ) = 1.22 , 95 % confidence interval ( CI ) = 0.88–1.69 ] or in secondary short-term smoking outcomes . Six-month prolonged abstinence was significantly higher in the iQuit arm ( control 8.9 % , iQuit 15.1 % ; OR = 1.81 , 95 % CI = 1.09–3.01 ) . iQuit support took on average 7.7 minutes ( st and ard deviation = 4.0 ) to deliver and 18.9 % ( 95 % CI = 14.8–23.7 % ) of intervention participants discontinued the text message support during the programme . Conclusions Tailored printed and text message self-help delivered alongside routine smoking cessation support in primary care does not significantly increase short-term abstinence , but may increase long-term abstinence and demonstrated feasibility and acceptability compared with routine cessation support alone INTRODUCTION Mobile-phone-based text ( SMS ) messaging is an effective method for delivering smoking cessation assistance ; however , little is known about optimal program use . This paper reports on the use of 2 forms of interaction ( reporting changes in quit status and emergency help ) among users of QuitTxt , an interactive , automated text messaging advice program . We examined preferences for messaging intensity , duration of use , and their associations with short-term cessation outcome or perceived helpfulness . METHODS QuitTxt was offered during participation in a previously reported r and omized controlled trial and was activated by 924 smokers or recent quitters , of whom 862 used it to a criterion level . Outcome data ( quit attempts , 7-day point prevalence abstinence , and perceived helpfulness ) were collected 1 month after first use . RESULTS Most ( 68.9 % ) accepted the default of 4 - 8 messages per day , and median use duration was 27 days . Half ( 49.1 % ) appeared to miss reporting at least 1 status change , with relapses less likely to be reported than quit progression . Emergency help was used by 27.0 % of those eligible for it ; emergency help was used more frequently among those with recent quit experience and lower nicotine dependence . Use of emergency help was unrelated to short-term cessation outcome . CONCLUSIONS The most notable finding is the variability in use . Some users complied fully with the requirement to report status changes , while even among those who did not , many found QuitTxt to be very helpful , suggesting that perfect congruence between message content and quit status is not essential . The use of emergency help functionality was relatively rare but was appreciated BACKGROUND Text messaging programs on mobile phones have shown some promise in helping people quit smoking . Text2Quit is an automated , personalized , interactive mobile health program that sends text messages to offer advice , support , and reminders about quitting smoking . PURPOSE To evaluate the effect of Text2Quit on biochemically confirmed repeated point prevalence abstinence in the context of an RCT conducted in the U.S. METHODS Participants ( n=503 ) were recruited on the Internet and r and omized to receive Text2Quit or self-help material . Between 2011 and 2013 , participants were surveyed at baseline and at 1 , 3 , and 6 months post-enrollment to assess smoking status . Saliva was collected from participants who reported not smoking in the past 7 days at the 6-month follow-up . An intent to treat analysis was used , and those lost to follow-up were categorized as smokers . All analyses were completed in 2013 . RESULTS Biochemically confirmed repeated point prevalence abstinence favored the intervention group , with 11.1 % abstinent compared to 5.0 % of the control group ( relative risk=2.22 , 95 % CI=1.16 , 4.26 , p<0.05 ) . Similarly , self-reported repeated point prevalence abstinence was higher in the intervention group ( 19.9 % ) than in the control group ( 10.0 % ) ( p<0.01 ) . Effects were found to be uniform across the analyzed demographic subgroups , although suggestive of a larger effect for non-whites than whites . CONCLUSIONS These results provide initial support for the relative efficacy of the Text2Quit program INTRODUCTION There is a need for innovation in both the enrollment of pregnant smokers in smoking cessation treatment programs and in the types of treatments offered . The study tests whether an interactive and intensive text messaging program , Quit4baby , can promote smoking cessation for pregnant women already enrolled in a health text messaging program , Text4baby . METHODS Between July 2015 and February 2016 , a total of 35,957 recruitment text messages were sent to Text4baby subscribers . Eligible pregnant smokers were enrolled and r and omized to receive Text4baby ( control ) or Text4baby and Quit4baby ( intervention ; N=497 ) . Participants were surveyed at 1 month , 3 months , and 6 months post-enrollment , and saliva sample s were collected at 3 months for biochemical verification of smoking status . Data were collected from 2015 to 2016 and analyzed in 2016 . RESULTS Using an intention-to-treat analysis , 28.80 % of the intervention group and 15.79 % of the control group reported not smoking in the past 7 days at 1 month ( p<0.01 ) , and 35.20 % of the intervention group and 22.67 % of the control group reported not smoking in the past 7 days at 3 months ( p<0.01 ) . Biochemical verification of smoking status at 3 months indicated no significant differences between groups ( 15.60 % in the intervention group and 10.93 % in the control group [ p=0.13 ] ) , although significant differences favoring the intervention were found for older smokers ( p<0.05 ) and for those who enrolled in their second or third trimester of pregnancy ( p<0.05 ) . Self-report of late pregnancy 7- and 30-day point prevalence abstinence favored the intervention group ( p<0.001 , p<0.01 ) . No significant differences were observed at the 6-month follow-up or in the postpartum period . CONCLUSIONS Results provide limited support of the efficacy of the Quit4baby text messaging program in the short term and late in pregnancy , but not in the postpartum period AIM To compare the effectiveness of proactive telephone counselling , reactive telephone counselling and an internet- and text-message-based intervention with a self-help booklet for smoking cessation . DESIGN A r and omized controlled trial with equal allocation to four conditions : ( 1 ) proactive telephone counselling ( n = 452 ) , ( 2 ) reactive telephone counselling ( n = 453 ) , ( 3 ) internet- and text-message-based intervention ( n = 453 ) and ( 4 ) self-help booklet ( control ) ( n = 452 ) . SETTING Denmark . PARTICIPANTS Smokers who had participated previously in two national health surveys were invited . Eligibility criteria were daily cigarette smoking , age ≥ 16 years , having a mobile phone and e-mail address . MEASUREMENTS Primary outcome was prolonged abstinence to 12 months from the end of the intervention period . FINDINGS At 12-month follow-up , higher prolonged abstinence was found in the proactive telephone counselling group compared with the booklet group [ 7.3 versus 3.6 % , odds ratio ( OR ) = 2.2 , 95 % confidence interval ( CI ) = 1.2 - 4.0 ] . There was no clear evidence of a difference in prolonged abstinence between the reactive telephone counselling group or the internet-based smoking cessation program and the booklet group : 1.8 versus 3.6 % , OR = 0.8 , 95 % CI = 0.6 - 1.2 and 5.3 versus 3.6 % , OR = 1.6 , 95 % CI = 0.8 - 3.0 , respectively . In the proactive telephone counselling group , the cost per additional 12-month quitter compared with the booklet group was £ 644 . CONCLUSIONS Proactive telephone counselling was more effective than a self-help booklet in achieving prolonged abstinence for 12 months . No clear evidence of an effect of reactive telephone counselling or the internet- and text-message-based intervention was found compared with the self-help booklet Background Text messaging ( short message service , SMS ) has been shown to be effective in delivering interventions for various diseases and health conditions , including smoking cessation . While there are many published studies regarding smoking cessation text messaging interventions , most do not provide details about the study ’s operational methods . As a result , there is a gap in our underst and ing of how best to design studies of smoking cessation text messaging programs . Objective The purpose of this paper is to detail the operational methods used to conduct a r and omized trial comparing three different versions of the National Cancer Institute ’s SmokefreeText ( SFTXT ) program , design ed for smokers 18 to 29 years of age . We detail our methods for recruiting participants from the Internet , reducing fraud , conducting online data collection , and retaining panel study participants . Methods Participants were recruited through website advertisements and market research online panels . Screening questions established eligibility for the study ( eg , 18 to 29 years of age , current smoker ) . Antifraud measures screened out participants who could not meet the study requirements . After completing a baseline survey , participants were r and omized to one of three study arms , which varied by type and timing of text message delivery . The study offered US $ 20 gift cards as incentives to complete each of four follow-up surveys . Automated email reminders were sent at design ated intervals to increase response rates . Research ers also provided telephone reminders to those who had not completed the survey after multiple email reminders . We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability . Results Recruitment methods drove 153,936 unique visitors to the SFTXT Study l and ing page and 27,360 began the screener . Based on the screening questions , 15,462 out of 27,360 responders ( 56.51 % ) were eligible to participate . Of the 15,462 who were eligible , 9486 passed the antifraud measures that were implemented ; however , 3882 failed to verify their email addresses or cell phone numbers , leaving 5604 who were invited to complete the baseline survey . Of the 5604 who were invited , 4432 completed the baseline survey , but only 4027 were retained for analysis because 405 did not receive the intervention . Conclusions Although antifraud measures helped to catch participants who failed study requirements and could have biased the data collected , it is possible that the email and cell phone verification check excluded some potentially eligible participants from the study . Future research should explore ways to implement verification methods without risking the loss of so many potential participants . Clinical Trial Clinical Trials.gov NCT01885052 ; https:// clinical trials.gov/ct2/show/NCT01885052 ; ( Archived by WebCite at http://www.webcitation.org/6iWzcmFdw INTRODUCTION To address the lack of smoking cessation programs available to young adults , Stop My Smoking ( SMS ) USA , a text messaging-based smoking cessation program , was developed and pilot tested . METHODS This was a two-arm r and omized controlled trial with adaptive r and omization ( arms were balanced by sex and smoking level [ heavy vs. light ] ) , conducted nationally in the United States . One hundred sixty-four 18- to 25-year-old daily smokers who were seriously thinking about quitting in the next 30 days were r and omized to either ( a ) the 6-week SMS USA intervention ( n = 101 ) or ( b ) an attention-matched control group aim ed at improving sleep and physical activity ( n = 63 ) . The main outcome measure was 3-month continuous abstinence , verified by a significant other . Participants but not research ers were blinded to study arm allocation . RESULTS Based upon intent-to-treat analyses , intervention participants ( 39 % ) were significantly more likely than control participants ( 21 % ) to have quit at 4 weeks postquit ( adjusted odds ratio [ aOR ] = 3.33 , 95 % confidence interval [ CI ] : 1.48 , 7.45 ) . Findings were not sustained at 3 months postquit , although rates in the SMS USA group were favored ( 40 % vs. 30 % , respectively ; aOR = 1.59 , 95 % CI : 0.78 , 3.21 ) . Subsequent analyses suggested that among intervention participants , SMS USA might be more influential for youth not currently enrolled in a higher education ( p = .06 ) . CONCLUSIONS Consistent with pilot studies , the sample was underpowered . Data suggest , however , that the SMS USA program affects smoking cessation rates at 4 weeks postquit . More research is needed before conclusions can be made about long-term impact . Identifying profiles of users for whom the program may be particularly beneficial also will be important Background Delivering effective tobacco dependence treatment that is feasible within lung cancer screening ( LCS ) programs is crucial for realizing the health benefits and cost savings of screening . Large-scale trials and systematic review s have demonstrated that digital cessation interventions ( i.e. web-based and text message ) are effective , sustainable over the long-term , scalable , and cost-efficient . Use of digital technologies is commonplace among older adults , making this a feasible approach within LCS programs . Use of cessation treatment has been improved with models that proactively connect smokers to treatment rather than passive referrals . Proactive referral to cessation treatment has been advanced through healthcare systems changes such as modifying the electronic health record to automatically link smokers to treatment . Methods This study evaluates the impact of a proactive enrollment strategy that links LCS-eligible smokers with an evidence -based intervention comprised of a web-based ( WEB ) program and integrated text messaging ( TXT ) in a three-arm r and omized trial with repeated measures at one , three , six , and 12 months post r and omization . The primary outcome is biochemically confirmed abstinence at 12 months post r and omization . We will r and omize 1650 smokers who present for a clinical LCS to : ( 1 ) a usual care control condition ( UC ) which consists of Ask – Advise – Refer ; ( 2 ) a digital ( WEB + TXT ) cessation intervention ; or ( 3 ) a digital cessation intervention combined with tobacco treatment specialist ( TTS ) counseling ( WEB + TXT + TTS ) . Discussion The scalability and sustainability of a digital intervention may represent the most cost-effective and feasible approach for LCS programs to proactively engage large numbers of smokers in effective cessation treatment . We will also evaluate the impact and cost-effectiveness of adding proven clinical intervention provided by a TTS . We expect that a combined digital/ clinical intervention will yield higher quit rates than digital alone , but that it may not be as cost-effective or feasible for LCS programs to implement . This study is innovative in its use of interoperable , digital technologies to deliver a sustainable , scalable , high-impact cessation intervention and to facilitate its integration within clinical practice . It will add to the growing knowledge base about the overall effectiveness of digital interventions and their role in the healthcare delivery system . Trial registration Clinical Trials.gov , NCT03084835 . Registered on 9 March 2017 ABSTRACT Little is known about the relative , additive , and interactive effects of different population -based treatments for smoking cessation . The goal of this study was to evaluate the main and interactive effects of five different smoking interventions . Using the multiphase optimization strategy ( MOST ) , 1,034 smokers who entered a Web site for smokers ( smokefree.gov ) were r and omly assigned to the “ on ” and “ off ” conditions of five smoking cessation interventions : the National Cancer Institute ’s ( NCI ) Web site ( www.smokefree.gov vs a “ lite ” Web site ) , telephone quitline counseling ( vs none ) , a smoking cessation brochure ( vs a lite brochure ) , motivational e-mail messages ( vs none ) , and mini-lozenge nicotine replacement therapy ( NRT vs none ) . Analyses showed that the NCI Web site and NRT both increased abstinence ; however , the former increased abstinence significantly only when it was not used with the e-mail messaging intervention ( messaging decreased Web site use ) . The other interventions showed little evidence of effectiveness . There was evidence that mailed nicotine mini-lozenges and the NCI Web site ( www.smokefree.gov ) provide benefit as population -based smoking interventions INTRODUCTION Smoking is the most preventable cause of morbidity and mortality in U.S. veterans . Rural veterans in particular have elevated risk for smoking and smoking-related illness . However , these veterans underutilize smoking cessation treatment , which suggests that interventions for rural veterans should optimize efficacy and reach . OBJECTIVE The primary goal of the current study is to evaluate the effectiveness of an intervention that combines evidence d based treatment for smoking cessation with smart-phone based , portable contingency management on smoking rates compared to a contact control intervention in a r and omized controlled trial among rural Veteran smokers . Specifically , Veterans will be r and omized to receive Abstinence Reinforcement Therapy ( ART ) which combines evidence d based cognitive-behavioral telephone counseling ( TC ) , a tele-medicine clinic for access to nicotine replacement ( NRT ) , and mobile contingency management ( mCM ) or a control condition ( i.e. , TC and NRT alone ) that will provide controls for therapist , medication , time and attention effects . METHODS Smokers were identified using VHA electronic medical records and recruited proactively via telephone . Participants ( N=310 ) are r and omized to either ART or a best practice control consisting of telephone counseling and telemedicine . Participating patients will be surveyed at 3-months , 6-months and 12-months post-r and omization . The primary outcome measure is self-reported and biochemically vali date d prolonged abstinence at 6-month follow-up . DISCUSSION This trial is design ed to test the relative effectiveness of ART compared to a telehealth-only comparison group . Dissemination of this mHealth intervention for veterans in a variety of setting s would be warranted if ART improves smoking outcomes for rural veterans and is cost-effective INTRODUCTION The objective of this study was to test the feasibility and acceptance of an intervention using text messaging ( short message service [ SMS ] ) for continuous individual support of smoking cessation in young adults . Additionally , the optimal feedback intensity was investigated , and short-term efficacy of the intervention was explored . METHODS In a cafeteria of the University of Greifswald , 575 visitors were screened for smoking status and usage of text messaging . From these , 194 persons who fulfilled the inclusion criteria of daily smoking and weekly usage of SMS were invited for participation in an SMS-based intervention . From these , 174 ( 90 % ) consented to participate . The participants were r and omly allocated to one of three study groups : ( a ) control condition without intervention , ( b ) intervention with one weekly SMS feedback ( 1SMS ) , or ( c ) intervention with three weekly SMS feedbacks ( 3SMS ) . In study groups ( b ) and ( c ) , individualized SMS feedbacks were sent to the participants weekly , based on data from the baseline assessment and a weekly SMS assessment of the stages of change according to the transtheoretical model . Program use and acceptance were compared between the two intervention groups differing in support intensity . An exploration of the short-term efficacy of the program was conducted by comparing the three study groups at the end of the 3-month intervention program on smoking variables . RESULTS The median number of replies to the weekly SMS assessment s was 12.5 in the 1SMS group and 13.0 in the 3SMS group ( not significant ) . The acceptance of the program did not differ between the intervention groups . At post assessment , no significant differences between the three study groups emerged on the examined smoking variables . DISCUSSION The high participation and retention rates suggest that SMS-based smoking cessation interventions are attractive for young adults . Support intensity did not affect the acceptance of the program . Longer follow-up periods and larger sample s are required to obtain conclusive results about the efficacy of this intervention approach BACKGROUND Text messaging has successfully supported smoking cessation . This study compares a mobile application with text messaging to support smoking cessation . MATERIAL S AND METHODS Young adult smokers 18 - 30 years old ( n = 102 ) participated in a r and omized pretest-posttest trial . Smokers received a smartphone application ( REQ-Mobile ) with short messages and interactive tools or a text messaging system ( onQ ) , managed by an expert system . Self-reported usability of REQ-Mobile and quitting behavior ( quit attempts , point-prevalence , 30-day point-prevalence , and continued abstinence ) were assessed in posttests . RESULTS Overall , 60 % of smokers used mobile services ( REQ-Mobile , 61 % , mean of 128.5 messages received ; onQ , 59 % , mean of 107.8 messages ) , and 75 % evaluated REQ-Mobile as user-friendly . A majority of smokers reported being abstinent at posttest ( 6 weeks , 53 % of completers ; 12 weeks , 66 % of completers [ 44 % of all cases ] ) . Also , 37 % ( 25%of all cases ) reported 30-day point-prevalence abstinence , and 32 % ( 22 % of all cases ) reported continuous abstinence at 12 weeks . OnQ produced more abstinence ( p<0.05 ) than REQ-Mobile . Use of both services predicted increased 30-day abstinence at 12 weeks ( used , 47 % ; not used , 20 % ; p = 0.03 ) . CONCLUSIONS REQ-Mobile was feasible for delivering cessation support but appeared to not move smokers to quit as quickly as text messaging . Text messaging may work better because it is simple , well known , and delivered to a primary inbox . These advantages may disappear as smokers become more experienced with new h and sets . Mobile phones may be promising delivery platforms for cessation services using either smartphone applications or text messaging OBJECTIVE To study whether demographic and smoking-related characteristics are associated with participation ( reach ) in a smoking cessation trial and subsequent use ( uptake ) of two specific smoking interventions ( Internet-based program and proactive telephone counseling ) . METHODS We used data from a four-arm r and omized smoking cessation trial ( 2011 ) . Participants ( n=1,809 ) were recruited among 9,924 smokers who previously participated in two health surveys in Denmark ( 2007 - 2008 and 2010 ) . Interventions were as follows : ( 1 ) an Internet-based smoking cessation program , ( 2 ) proactive telephone counseling , ( 3 ) reactive telephone counseling and ( 4 ) a self-help booklet . RESULTS Reach ( defined as the proportion accepting to participate in the trial of those invited ) was highest among persons aged 40 - 59 years , women , heavy smokers and persons with long education . Among trial participants , uptake ( defined as any use of the specific intervention at 1-month follow-up ) was 69 % for the Internet-based program , 74 % and 9 % for proactive and reactive telephone counseling , respectively , and 84 % for the self-help booklet . Young age was associated with the uptake of the Internet-based program , and short education was associated with using proactive telephone counseling . CONCLUSIONS Internet-based interventions and proactive telephone counseling appeal to different age and educational groups . Further , offering similar intervention content by a proactive and a reactive approach can be associated with different intervention uptake BACKGROUND Whether financial incentives , pharmacologic therapies , and electronic cigarettes ( e‐cigarettes ) promote smoking cessation among unselected smokers is unknown . METHODS We r and omly assigned smokers employed by 54 companies to one of four smoking‐cessation interventions or to usual care . Usual care consisted of access to information regarding the benefits of smoking cessation and to a motivational text‐messaging service . The four interventions consisted of usual care plus one of the following : free cessation aids ( nicotine‐replacement therapy or pharmacotherapy , with e‐cigarettes if st and ard therapies failed ) ; free e‐cigarettes , without a requirement that st and ard therapies had been tried ; free cessation aids plus $ 600 in rewards for sustained abstinence ; or free cessation aids plus $ 600 in redeemable funds , deposited in a separate account for each participant , with money removed from the account if cessation milestones were not met . The primary outcome was sustained smoking abstinence for 6 months after the target quit date . RESULTS Among 6131 smokers who were invited to enroll , 125 opted out and 6006 underwent r and omization . Sustained abstinence rates through 6 months were 0.1 % in the usual‐care group , 0.5 % in the free cessation aids group , 1.0 % in the free e‐cigarettes group , 2.0 % in the rewards group , and 2.9 % in the redeemable deposit group . With respect to sustained abstinence rates , redeemable deposits and rewards were superior to free cessation aids ( P<0.001 and P=0.006 , respectively , with significance levels adjusted for multiple comparisons ) . Redeemable deposits were superior to free e‐cigarettes ( P=0.008 ) . Free e‐cigarettes were not superior to usual care ( P=0.20 ) or to free cessation aids ( P=0.43 ) . Among the 1191 employees ( 19.8 % ) who actively participated in the trial ( the “ engaged ” cohort ) , sustained abstinence rates were four to six times as high as those among participants who did not actively engage in the trial , with similar relative effectiveness . CONCLUSIONS In this pragmatic trial of smoking cessation , financial incentives added to free cessation aids result ed in a higher rate of sustained smoking abstinence than free cessation aids alone . Among smokers who received usual care ( information and motivational text messages ) , the addition of free cessation aids or e‐cigarettes did not provide a benefit . ( Funded by the Vitality Institute ; Clinical Trials.gov number , NCT02328794 . INTRODUCTION Neighborhood features such as the density of tobacco outlets relative to one 's home and evaluations of safety of one 's activity space ( routine locations ) , are known to influence health behaviors . Underst and ing the time-varying nature of these aspects of the urban ecology provides unique insights into the dynamic interactions of individuals and their environments . METHODS The present study tested the time-varying effects of tobacco outlets and perceived safety within a r and omized controlled trial of an adolescent text-messaging smoking intervention . We used ecological momentary assessment data ( EMA ) from an automated text-messaging smoking cessation r and omized trial with 197 primarily African American urban adolescents . We employed a time-varying effect model to estimate the effects of density of tobacco outlets within one-half mile of participants ' home locations ( time-invariant covariate ) and evaluations of safety of their activity space ( time-varying covariate ) on momentary smoking over 6 months by treatment condition . The time-varying effect model approach models behavioral change and associations of coefficients expressed dynamically and graphically represented as smooth functions of time . RESULTS Differences in trajectories of smoking between treatment conditions were apparent over the course of the study . During months 2 and 6 , the association between tobacco outlet density and smoking was significantly stronger in the control condition , suggesting treatment dampens this association during these time periods . The intervention also significantly reduced the association of perceived safety and smoking among the treatment condition during months 3 through 6 . CONCLUSIONS Results support testing the time-varying effects of urban ecological features and perceptions of safety among adolescents in text-based smoking cessation interventions . IMPLICATION S This study makes a unique contribution towards underst and ing the time-varying effects of urban neighborhoods on adolescent tobacco use within the context of a text-delivered intervention . Helping to adjust the long-held conceptualization of intervention effects as a static outcome , to that of a dynamic , time-varying process , is an important contribution of this study . The ability to specify when behavioral change occurs within the context of a r and omized control trial provides underst and ing into the time-varying treatment effects of text-based smoking intervention . For example , research ers can modify the intervention to have strategically timed booster sessions that align with when the odds of smoking begin to increase in order to provide more precise treatment . The current study results show that increasing support to participants during months 2 and 4 may help suppress smoking over the course of a 6-month intervention Aim : To conduct a pilot r and omised controlled trial of mobile phone-based smoking cessation support intervention for the UK population . Design : R and omised controlled trial ( txt2stop ) . Setting : Community . Participants : 200 participants responding to radio , poster and leaflet-based promotions regarding the trial . Main outcome measures : The response rate for the outcome measures planned for the main trial . Participants ’ qualitative responses to open-ended questions about the intervention content . Secondary outcomes were the outcomes planned for the main trial including the point prevalence of self-reported smoking at 4 weeks and pooled effect estimate for the short-term results for the STOMP and txt2stop trials . Results : The response rate at 4 weeks was 96 % and at 6 months was 92 % . The results at 4 weeks show a doubling of self-reported quitting relative risk ( RR ) 2.08 ( 95 % CI 1.11 to 3.89 ) , 26 % vs 12 % . The pooled effect estimate combining txt2stop and a previous New Zeal and trial in the short term is RR 2.18 ( 95 % CI 1.79 to 2.65 ) . Conclusions : Mobile phone-based smoking cessation is an innovative means of delivering smoking cessation support , which doubles the self-reported quit rate in the short term . It could represent an important , but as yet largely unused , medium to deliver age-appropriate public health measures . The long-term effect of this mobile phone-based smoking cessation support will be established by a large r and omised controlled trial currently in recruitment Introduction Mindfulness training may reduce smoking rates and lessen the association between craving and smoking . This trial tested the efficacy of mindfulness training via smartphone app to reduce smoking . Experience sampling was used to measure real time craving , smoking and mindfulness . Methods A research er-blind , parallel r and omized controlled trial compared the efficacy of mobile mindfulness training with experience sampling ( MMT-ES ; Craving to Quit ) vs. experience sampling-only ( ES ) to ( 1 ) increase one-week point-prevalence abstinence rates at 6 months , and ( 2 ) lessen the association between craving and smoking . A modified intent-to-treat approach was used for treatment starters ( MMT-ES n=143 ; ES n=182 ; 72 % female , 81 % white , age 41±12yr . ) . Results No group difference was found in smoking abstinence at 6 months ( overall , 11.1 % ; MMT-ES , 9.8 % ; ES , 12.1 % ; χ2(1)=.43 , p=.51 ) . From baseline to 6 months , both groups showed a reduction in cigarettes per day ( p<.0001 ) , craving strength ( p<.0001 ) and frequency ( p<.0001 ) , and an increase in mindfulness ( p<.05 ) . Using experience sampling data , a craving by group interaction ( F(1,3785)=3.71 , p=.05 ) was observed , driven by a stronger positive association between craving and cigarettes per day for ES ( t=4.96 , p<.0001 ) versus MMT-ES ( t=2.03 , p=.04 ) . Within MMT-ES , the relationship between craving and cigarettes per day decreased as treatment completion increased ( F(1,104)=4.44 , p=.04 ) . Conclusions Although mindfulness training via smartphone app did not lead to reduced smoking rates compared with control , our findings provide preliminary evidence that mindfulness training via smartphone app may help lessen the association between craving and smoking , an effect that may be meaningful to support quitting in the longer-term . Trial registration Clinical trials.gov NCT02134509 . Registered 7 May 2014 . Implication s This is the first reported full-scale r and omized controlled trial of any smartphone app for smoking cessation . Findings provide preliminary evidence that smartphone app-based mindfulness training with experience sampling may lessen the association between craving and smoking , an effect that did not lead to reduced smoking abstinence rates compared with control but may be meaningful to support quitting and prevent relapse in the longer-term Background Actively referring smokers to smoking cessation ( SC ) services could increase quitting and is scalable for the population . The objective of this study is to compare 2 different intensities of SC active referral for smokers in the community of Hong Kong . Methods / design This is a single-blind , parallel 3-armed cluster r and omized controlled trial ( c RCT ) consisting of high-intensity SC active referral ( HAR Group ) , low-intensity SC referral by text messaging on promoting SC services use ( Text Group ) and a control group receives general very brief advice . Biochemically vali date d daily smokers will be proactively recruited in the community from 68 clusters ( recruitment sessions ) . The primary outcome is self-reported 7-days point prevalence abstinence ( PPA ) at the 3- and 6- month follow-ups . Secondary outcomes are SC service use , smoking reduction rate ( SRR , daily cigarette consumption reduced by ≥50 % ; excluding quitters ) and biochemically vali date d quit rate ( exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml ) . Outcome assessors and data analysts will be blinded to group allocation . Intention-to-treat principle and Generalized Estimating Equation ( GEE ) regressions will be used for data analysis . Discussion This will be the first trial on evaluating the efficacy of the 2 different intensities of SC active referral on smoking cessation in community smokers . It is anticipated that the results from this trial can provide evidence to the effectiveness of high-intensity active referral to SC services and low intensity SC referral by using text messaging in achieving smoking abstinence . Trial registration Clinical Trials.gov Identifier : NCT02804880 , June 17 , 2016 Introduction Verifying abstinence remotely in trials of digital cessation interventions remains a major challenge . This study reports on using personal carbon monoxide ( CO ) monitors to assess abstinence in a pragmatic trial of a st and alone cessation app involving automated recruitment with no research er contact . Methods The study involved secondary data analysis of remote CO testing in a r and omized trial ( IS RCT N10548241 ) comparing two versions of a cessation app ( BupaQuit ) . Trial participants were adult UK-based smokers interested in quitting , who were recruited online ( 02/2015–03/2016 ) . Participants were followed-up through the app , email or phone at 4 weeks . Fifty-nine participants reporting not smoking were posted a personal CO monitor with instructions , and emailed two reminders . The monitors required installing software on a Windows PC . Participants were not reimbursed but retained the device . We recorded the proportion of CO tests returned , test results , self-reported ease of use , correct use , acceptability , and reasons for missing results . Results Fifteen ( 25.4 % ) CO results were returned , of which 86.6 % were < 10 ppm and 53.3 % were < 5 ppm , indicating abstinence ( corresponding to 20.9 % and 12.9 % of all trial participants self-reporting abstinence , respectively ) . These 15 participants found the test easy , acceptable and believed they conducted it correctly . Eight ( 18.2 % ) of the missing results were accounted for , including no access to a Windows PC , barriers to receiving packages , and unwillingness to share results . Conclusion Remote validation using personal CO monitors may not yet be feasible in pragmatic studies of cessation apps in which participants are recruited with no reimbursement or direct contact with research ers Background Digital mobile technology presents a promising medium for reaching young adults with smoking cessation interventions because they are the heaviest users of this technology . Objective The aim of this study was to determine the efficacy of an evidence -informed smartphone app for smoking cessation , Crush the Crave ( CTC ) , on reducing smoking prevalence among young adult smokers in comparison with an evidence -informed self-help guide , On the Road to Quitting ( OnRQ ) . Methods A parallel , double-blind , r and omized controlled trial with 2 arms was conducted in Canada to evaluate CTC . In total , 1599 young adult smokers ( aged 19 to 29 years ) intending to quit smoking in the next 30 days were recruited online and r and omized to receive CTC or the control condition OnRQ for a period of 6 months . The primary outcome measure was self-reported continuous abstinence at the 6-month follow-up . Results Overall follow-up rates were 57.41 % ( 918/1599 ) and 60.48 % ( 967/1599 ) at 3 and 6 months , respectively . Moreover , 45.34 % ( 725/1599 ) of participants completed baseline , 3- , and 6-month follow-up . Intention-to-treat analysis ( last observation carried forward ) showed that continuous abstinence ( N=1599 ) at 6 months was not significantly different at 7.8 % ( 64/820 ) for CTC versus 9.2 % ( 72/779 ) for OnRQ ( odds ratio ; OR 0.83 , 95 % CI 0.59 - 1.18 ) . Similarly , 30-day point prevalence abstinence at 6 months was not significantly different at 14.4 % ( 118/820 ) and 16.9 % ( 132/779 ) for CTC and OnRQ , respectively ( OR 0.82 , 95 % CI 0.63 - 1.08 ) . However , these rates of abstinence were favorable compared with unassisted 30-day quit rates of 11.5 % among young adults . Secondary measures of quit attempts and the number of cigarettes smoked per day at 6-month follow-up did not reveal any significant differences between groups . For those who completed the 6-month follow-up , 85.1 % ( 359/422 ) of young adult smokers downloaded CTC as compared with 81.8 % ( 346/423 ) of OnRQ , χ21(N=845)=1.6 , P=.23 . Furthermore , OnRQ participants reported significantly higher levels of overall satisfaction ( mean 3.3 [ SD 1.1 ] vs mean 2.6 [ SD 1.3 ] ; t644=6.87 , P<.001 ) , perceived helpfulness ( mean 5.8 [ SD 2.4 ] vs mean 4.3 [ SD 2.6 ] , t657=8.0 , P<.001 ) , and frequency of use ( mean 3.6 [ SD 1.2 ] vs mean 3.2 [ SD 1.1 ] , t683=5.7 , P<.001 ) compared with CTC participants . Conclusions CTC was feasible for delivering cessation support but was not superior to a self-help guide in helping motivated young adults to quit smoking . CTC will benefit from further formative research to address satisfaction and usage . As smartphone apps may not serve as useful alternatives to printed self-help guides , there is a need to conduct further research to underst and how digital mobile technology smoking cessation interventions for smoking cessation can be improved . Trial Registration Clinical Trials.gov NCT01983150 ; http:// clinical trials.gov/ct2/show/NCT01983150 ( Archived by WebCite at http://www.webcitation.org/6VGyc0W0i Background China has the highest global prevalence of cigarette smokers , accounting for more than 40 % of the total cigarette consumption in the world . Considering the shortage of smoking cessation services in China , and the acceptability , feasibility , and efficacy of mobile-phone-based text messaging interventions for quitting smoking in other countries , we conducted a mobile-phone-based smoking cessation study in China . Methods and findings We conducted a r and omized controlled trial in China across 30 cities and provinces from August 17 , 2016 , to May 27 , 2017 . Adult smokers aged 18 years and older with the intention to quit smoking were recruited and r and omized to a 12-week high-frequency messaging ( HFM ) or low-frequency messaging ( LFM ) intervention ( “ Happy Quit ” ) or to a control group in a 5:2:3 ratio . The control group received only text messages unrelated to quitting . The primary outcome was biochemically verified continuous smoking abstinence at 24 weeks . Secondary outcomes included ( 1 ) self-reported 7-day point prevalence of abstinence ( i.e. , not even a puff of smoke , for the last 7 days ) at 1 , 4 , 8 , 12 , 16 , 20 , and 24 weeks ; ( 2 ) self-reported continuous abstinence at 4 , 12 , and 24 weeks ; and ( 3 ) self-reported average number of cigarettes smoked per day . A total of 1,369 participants received 12 weeks of intervention or control text messages with continued follow-up for 12 weeks . The baseline characteristics of participants among the HFM ( n = 674 ) , LFM ( n = 284 ) , and control ( n = 411 ) groups were similar . The study sample included 1,295 ( 94.6 % ) men ; participants had a mean age of 38.1 ( SD 9.79 ) years and smoked an average of 20.1 ( SD 9.19 ) cigarettes per day . We included the participants in an intention-to-treat analysis . Biochemically verified continuous smoking abstinence at 24 weeks occurred in 44/674 participants in the HFM group ( 6.5 % ) , 17/284 participants in the LFM group ( 6.0 % ) , and 8/411 participants ( 1.9 % ) in the control group ; participants in both the HFM ( odds ratio [ OR ] = 3.51 , 95 % CI 1.64–7.55 , p < 0.001 ) and the LFM ( OR = 3.21 , 95 % CI 1.36–7.54 ] , p = 0.002 ) intervention groups were more likely to quit smoking than those in the control group . However , there was no difference in quit rate between the HFM and LFM interventions . We also found that the 7-day point quit rate from week 1 to week 24 ranged from approximately 10 % to more than 26 % with the intervention and from less than 4 % to nearly 12 % without the intervention . Those who continued as smokers in the HFM group smoked 1 to 3 fewer cigarettes per day than those in the LFM group over the 24 weeks of trial . Among study limitations , the participants were able to use other smoking cessation services ( although very few participants reported using them ) , cotinine tests can only detect smoking status for a few days , and the proportion of quitters was small . Conclusions Our findings demonstrate that a mobile-phone-based text messaging intervention ( Happy Quit ) , with either high- or low-frequency messaging , led to smoking cessation in the present study , albeit in a low proportion of smokers , and can therefore be considered for use in large-scale intervention efforts in China . Mobile-phone-based interventions could be paired with other smoking cessation services for treatment-seeking smokers in China . Trial registration Clinical Trials.gov NCT02693626 Background Mobile health ( mHealth ) apps have the potential to increase smoking cessation , but little research has been conducted with Aboriginal communities in Australia . Objective We conducted a pilot study to assess the feasibility and acceptability and explore the effectiveness of a novel mHealth app to assist Aboriginal people to quit smoking . Methods A pilot r and omized controlled trial ( RCT ) and process evaluation comprising usage analytics data and in-depth interviews was conducted . Current Aboriginal smokers ( > 16 years old ) , who were willing to make a quit attempt in the next month , were recruited from Aboriginal Community Controlled Health Services and a government telephone coaching service . The intervention was a multifaceted And roid or iOS app comprising a personalized profile and quit plan , text and in-app motivational messages , and a challenge feature allowing users to compete with others . The comparator was usual cessation support services . Outcome data collection and analysis were conducted blinded to treatment allocation . The primary outcome was self-reported continuous smoking abstinence verified by carbon monoxide breath testing at 6 months . Secondary outcomes included point prevalence of abstinence and use of smoking cessation therapies and services . Results A total of 49 participants were recruited . Competing service delivery priorities , the lack of re sources for research , and lack of support for r and omization to a control group were the major recruitment barriers . At baseline , 23/49 ( 47 % ) of participants had tried to quit in recent weeks . At 6-month follow-up , only 1 participant ( intervention arm ) was abstinent . The process evaluation highlighted low to moderate app usage ( 3 - 10 new users per month and 4 - 8 returning users per month ) , an average of 2.9 sessions per user per month and 6.3 min per session . Key themes from interviews with intervention participants ( n=15 ) included the following : ( 1 ) the powerful influence of prevailing social norms around acceptability of smoking ; ( 2 ) high usage of mobile devices for phone , text , and social media but very low use of other smartphone apps ; ( 3 ) the role of family and social group support in supporting quit attempts ; and ( 4 ) low awareness and utilization of smoking cessation support services . Despite the broad acceptability of the app , participants also recommended technical improvements to improve functionality , greater customization of text messages , integration with existing social media platforms , and gamification features . Conclusions Smoking cessation apps need to be integrated with commonly used functions of mobile phones and draw on social networks to support their use . Although they have the potential to increase utilization of cessation support services and treatments , more research is needed to identify optimal implementation models . Robust evaluation is critical to determine their impact ; however , an RCT design may not be feasible in this setting . Trial Registration Australian and New Zeal and Clinical Trials Registry ACTRN12616001550493 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=371792 ( Archived by WebCite at http://www.webcitation.org/76TiV7HA6 ) AIMS To test the population impact of offering automated smoking cessation interventions via the internet and /or by mobile phone . DESIGN Pragmatic r and omized controlled trial with five conditions : offer of ( i ) minimal intervention control ; ( ii ) QuitCoach personalized tailored internet-delivered advice program ; ( iii ) onQ , an interactive automated text-messaging program ; ( iv ) an integration of both QuitCoach and onQ ; and ( v ) a choice of either alone or the combined program . SETTING Australia , via a mix of internet and telephone contacts . PARTICIPANTS A total of 3530 smokers or recent quitters recruited from those interested in quitting , and seeking self-help re sources ( n = 1335 ) or cold-contacted from internet panels ( n = 2195 ) . MEASUREMENTS The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment . FINDINGS Only 42.5 % of those offered one of the interventions took it up to a minimal level . The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [ odds ratio ( OR ) = 1.48 ; 95 % confidence interval ( CI ) : 0.98 - 2.24 ] ( missing cases treated as smokers ) , with no differences between the interventions . Among those who used an intervention , there was a significant overall increase in abstinence ( OR = 1.95 ; CI : 1.04 - 3.67 ) , but not clearly so when analysing only cases with reported outcomes . Success rates were greater among those recruited after seeking information compared to those cold-contacted . CONCLUSIONS Smokers interested in quitting who were assigned r and omly to an offer of either the QuitCoach internet-based support program and /or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those r and omized to an offer of a simple information website INTRODUCTION Study aims were to assess the feasibility and acceptability of a tailored self-help smoking cessation intervention for pregnant smokers ( MiQuit ) . Secondary aims were to assess whether MiQuit affected cognitive determinants of quitting and to provide a range of potential effect sizes of the intervention effect on smoking abstinence . METHODS A r and omized controlled trial was undertaken in which pregnant smokers were allocated to either receive MiQuit , a tailored self-help leaflet followed by an 11-week program of tailored text messages , or to a control group , receiving a nontailored self-help leaflet . Participants were 207 pregnant smokers identified by community midwives across 7 NHS Trusts ( United Kingdom ) . At 3-month follow-up , intervention acceptability , cognitive determinants of quitting , and smoking outcomes ( self-reported and cotinine-vali date d 7-day point prevalence abstinence ) were assessed . RESULTS Feasibility : 94 % ( 95 % CI 89%-99 % ) of MiQuit participants reported receiving both intervention components . Acceptability : 9 % ( 95 % CI 4%-15 % ) of MiQuit participants opted to discontinue the text messages . Mechanism : compared with controls , MiQuit participants were more likely to set a quit date ( p = .049 ) and reported higher levels of self-efficacy ( p = .024 ) , harm beliefs ( p = .052 ) , and determination to quit ( p = .019 ) . Potential efficacy : self-reported abstinence-MiQuit 22.9 % , control 19.6 % ; odds ratio ( OR ) = 1.22 , 95 % CI 0.62 - 2.41 ; cotinine-vali date d abstinence-MiQuit 12.5 % , control 7.8 % ; OR = 1.68 , 95 % CI 0.66 - 4.31 . CONCLUSIONS Delivering tailored smoking cessation support to pregnant smokers via leaflet and text message is feasible and acceptable . The positive effects of MiQuit on cognitive determinants and the likelihood of setting a quit date are encouraging . A larger efficacy trial is warranted INTRODUCTION Arguably , the greatest advantage of ecological momentary assessment ( EMA ) studies is that data are collected repeatedly in real-time and real-world situations , which reduces recall and situational biases and thus improves the accuracy and validity of the data collected . However , the validity of EMA data is contingent upon compliance rates . If participant characteristics are related to missing data , analyses should control for these factors , or they should be targeted in EMA training sessions . This study evaluates the impact of demographic and smoking-related participant characteristics on compliance to an EMA smoking study protocol . METHODS Prequit-day data were taken from the control arm of an ongoing r and omized controlled trial of a smoking-cessation program . After training , 119 participants were asked to carry a mobile device with them at all times for ~6 days and to log every cigarette they smoked in addition to completing r and omly scheduled assessment s. Different types of compliance were assessed : the percentage of completed r and om prompts ( signal-contingent compliance ) , the percentage of logged cigarettes per day compared to a timeline follow-back measure , and the correlation between logged cigarettes and a carbon monoxide assessment 2 hr later ( both event-contingent compliance ) . RESULTS Overall compliance rates were 78.48 % for event-contingent and 72.17 % for signal-contingent compliance . None of the demographic or smoking-related participant characteristics predicted signal-contingent compliance ; however , female participants showed higher event-contingent compliance than male participants , and Caucasian participants showed higher event-contingent compliance than non-Caucasian participants . CONCLUSIONS Compliance did not depend on smoking-related characteristics . EMA is a valid method for assessing smoking behavior in real-time and real-world setting ABSTRACT Background : Smoking rates among people living with human immunodeficiency virus/acquired immunodeficiency syndrome ( HIV/AIDS ; PLWHA ) are at least twice as high as rates in the general population . Consistent with the reciprocal model of pain and smoking , PLWHA with pain who smoke may use smoking as a means of coping with pain , thus presenting a potential barrier to quitting . The aim of this study is to better underst and how pain relates to smoking cessation among 474 HIV-positive adults enrolled in a cell phone – delivered smoking cessation trial . Methods : Participants were r and omly assigned to usual care ( cessation advice and self-help material s ) or 11 sessions of cell phone – delivered smoking cessation treatment . Pain , as assessed by the Medical Outcomes Study -HIV Health Survey ( MOS-HIV ) , and point prevalence abstinence were collected at the 3-month treatment end and at 6- and 12-month follow-ups . Self-reported abstinence was biochemically verified by expired carbon monoxide ( CO ) level of < 7 ppm . Results : Using multilevel modeling for binary outcome data , the authors examined the relationship between pain and abstinence , from treatment end through the 12-month follow-up . Consistent with the authors ' hypothesis , less pain was associated with greater likelihood of 24-hour ( β = .01 , t(651 ) = 2.53 , P = .01 ) and 7-day ( β = .01 , t(651 ) = 2.35 , P = .02 ) point prevalence abstinence , controlling for age , gender , baseline pain , nicotine dependence , and treatment group . No pain × treatment group interaction was observed . Conclusions : These results can help us to better identify PLWHA at greater risk for relapse in smoking cessation treatment . Future research may examine the effectiveness of more comprehensive smoking cessation treatment that incorporates aspects of pain management for PLWHA who smoke and have high pain and symptom burden PURPOSE : Efficient ways are needed to implement the secondary prevention ( SP ) of coronary heart disease . Because few studies have investigated Web-based SP programs , our aim was to determine the usefulness of a new Web-based telemonitoring system , connecting patients provided with self-measurement devices and care managers via mobile phone text messages , as a tool for SP . METHODS : A single-blind , r and omized controlled , clinical trial of 203 acute coronary syndrome ( ACS ) survivors , was conducted at a hospital in Madrid , Spain . All patients received lifestyle counseling and usual-care treatment . Patients in the telemonitoring group ( TMG ) sent , through mobile phones , weight , heart rate , and blood pressure ( BP ) weekly , and capillary plasma lipid profile and glucose monthly . A cardiologist accessed these data through a Web interface and sent recommendations via short message service . Main outcome measures were BP , body mass index ( BMI ) , smoking status , low-density lipoprotein-cholesterol ( LDL-c ) , and glycated hemoglobin A1c ( HbA1c ) . RESULTS : At 12-month followup , TMG patients were more likely ( RR = 1.4 ; 95 % CI = 1.1−1.7 ) to experience improvement in cardiovascular risk factors profile than control patients ( 69.6 % vs 50.5 % , P = .010 ) . More TMG patients achieved treatment goals for BP ( 62.1 % vs 42.9 % , P = .012 ) and HbA1c ( 86.4 % vs 54.2 % , P = .018 ) , with no differences in smoking cessation or LDL-c . Body mass index was significantly lower in TMG ( −0.77 kg/m2 vs + 0.29 kg/m2 , P = .005 ) . CONCLUSIONS : A telemonitoring program , via mobile phone messages , appears to be useful for improving the risk profile in ACS survivors and can be an effective tool for secondary prevention , especially for overweight patients |
1,396 | 15,274,846 | At 12-month follow-up , sirolimus- or paclitaxel-eluting stents were effective and safe in patients with de novo lesions and low or medium risk of restenosis .
At current market prices , the widespread use of these stents would involve an increase in health care expenditure for the different sensitivity scenarios we evaluated . | INTRODUCTION AND OBJECTIVES Antiproliferative drug-coated stents are a possible solution for post-angioplasty coronary restenosis .
Here we analyze their efficacy , effectiveness and safety , and estimate the economic impact of their use in Spain . | Background —The use of a stent to deliver a drug may reduce in-stent restenosis . Paclitaxel interrupts the smooth muscle cell cycle by stabilizing microtubules , thereby arresting mitosis . Methods and Results —On the basis of prior animal studies , the European evaLUation of the pacliTaxel Eluting Stent ( ELUTES ) pilot clinical trial ( n=190 ) investigated the safety and efficacy of V-Flex Plus coronary stents ( Cook Inc ) coated with escalating doses of paclitaxel ( 0.2 , 0.7 , 1.4 , and 2.7 & mgr;g/mm2 stent surface area ) applied directly to the abluminal surface of the stent in de novo lesions compared with bare stent alone . The primary efficacy end point was angiographic percent diameter stenosis at 6 months . At angiographic follow-up , percent diameter stenosis was 33.9±26.7 % in controls ( n=34 ) and 14.2±16.6 % in the 2.7-&mgr;g/mm2 group ( n=31 ; P = 0.006 ) . Late loss decreased from 0.73±0.73 to 0.11±0.50 mm ( P = 0.002 ) . Binary restenosis ( ≥50 % at follow-up ) decreased from 20.6 % to 3.2 % ( P = 0.056 ) , with no significant benefit from intermediate paclitaxel doses . Freedom from major adverse cardiac events in the highest ( effective ) dose group was 92 % , 89 % , and 86 % at 1 , 6 , and 12 months , respectively ( P = NS versus control ) . No late stent thromboses were seen in any treated group despite clopidogrel treatment for 3 months only . Conclusions —Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent , at a dose density of 2.7 & mgr;g/mm2 , reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects Background —The safety and efficacy of sirolimus-eluting stenting have been demonstrated , but the outcome of patients treated with this novel technology beyond the first year remains unknown . We sought to evaluate the angiographic , intravascular ultrasound ( IVUS ) , and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation . Methods and Results —This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting ( slow release [ SR ] , n=15 , and fast release [ FR ] , n=15 ) in São Paulo , Brazil . Twenty-eight patients underwent 2-year angiographic and IVUS follow-up . No deaths occurred during the study period . In-stent late loss was slightly greater in the FR group ( 0.28±0.4 mm ) than in the SR group ( −0.09±0.23 mm , P = 0.007 ) . No patient had in-stent restenosis . At 2-year follow-up , only 1 patient ( FR group ) had a 52 % diameter stenosis within the lesion segment , which required repeat revascularization . The target-vessel revascularization rate for the entire cohort was 10 % ( 3/30 ) at 2 years . All other patients had ≤35 % diameter stenosis . Angiographic lumen loss at the stent edges was also minimal ( in-lesion late loss was 0.33±0.42 mm [ FR ] and 0.13±0.29 mm [ SR ] ) . In-stent neointimal hyperplasia volume , as detected by IVUS , remained minimal after 2 years ( FR= 9.90±9 mm3 and SR=10.35±9.3 mm3 ) . Conclusions —This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans . In-stent lumen dimensions remained essentially unchanged at 2-year follow-up in the 2 groups , although angiographic lumen loss was slightly higher in the FR group . Restenosis “ catch-up ” was not found in our patient population Composite outcomes , in which multiple end points are combined , are frequently used as primary outcome measures in r and omized trials and are often associated with increased statistical efficiency . However , such measures may prove challenging for the interpretation of results . In this article , we examine the use of composite outcomes in major clinical trials , assess the arguments for and against them , and provide guidance on their application and reporting . To assess incidence and quality of reporting , we systematic ally review ed the use of composite end points in clinical trials in Annals of Internal Medicine , BMJ , Circulation , Clinical Infectious Diseases , Journal of the American College of Cardiology , JAMA , Lancet , New Engl and Journal of Medicine , and Stroke from 1997 through 2001 using a sensitive search strategy . We selected for review 167 original reports of r and omized trials ( with a total of 300 276 patients ) that included a composite primary outcome that incorporated all-cause mortality . Sixty-three trials ( 38 % ) were neutral both for the primary end point and the mortality component . Sixty trials ( 36 % ) reported significant results for the primary outcome measure but not for the mortality component . Only 6 trials ( 4 % ) were significant for the mortality component but not for the primary composite outcome , whereas 19 trials ( 11 % ) were significant for both . Twenty-two trials ( 13 % ) were inadequately reported . Our review suggests that reporting of composite outcomes is generally inadequate , implying that the results apply to the individual components of the composite outcome rather than only to the overall composite . Current guidelines for the undertaking and reporting of clinical trials could be revised to reflect the common use of composite outcomes in clinical trials BACKGROUND The placement of stents in coronary arteries has been shown to reduce restenosis in comparison to balloon angioplasty . However , clinical use of intracoronary stents is impeded by the risk of subacute stent thrombosis and complications associated with the anticoagulant regimen . To reduce these complications , the hypothesis that systemic anticoagulation is not necessary when adequate stent expansion is achieved was prospect ively evaluated on a consecutive series of patients who received intracoronary stents . METHODS AND RESULTS From March 1993 to January 1994 , 359 patients underwent Palmaz-Schatz coronary stent insertion . After an initial successful angiographic result with < 20 % stenosis by visual estimation had been achieved , intravascular ultrasound imaging was performed . Further balloon dilatation of the stent was guided by observation of the intravascular ultrasound images . All patients with adequate stent expansion confirmed by ultrasound were treated only with antiplatelet therapy ( either ticlopidine for 1 month with short-term aspirin for 5 days or only aspirin ) after the procedure . Clinical success ( procedure success without early postprocedural events ) at 2 months was achieved in 338 patients ( 94 % ) . With an inflation pressure of 14.9 + /- 3.0 atm and a balloon-to-vessel ratio of 1.17 + /- 0.19 , optimal stent expansion was achieved in 321 of the 334 patients ( 96 % ) who underwent intravascular ultrasound evaluation , with these patients receiving only antiplatelet therapy after the procedure . Despite the absence of anticoagulation , there were only two acute stent thromboses ( 0.6 % ) and one subacute stent thrombosis ( 0.3 % ) at 2-month clinical follow-up . Follow-up angiography at 3 to 6 months documented two additional occlusions ( 0.6 % ) at the stent site . At 6-month clinical follow-up , angiographically documented stent occlusion had occurred in 5 patients ( 1.6 % ) . At 6-month clinical follow-up , there was a 5.7 % incidence of myocardial infa rct ion , a 6.4 % rate of coronary bypass surgery , and a 1.9 % incidence of death . Emergency intervention ( emergency angioplasty or bailout stent ) for a stent thrombosis event was performed in 3 patients ( 0.8 % ) . The overall event rate was relatively high because of intraprocedural complications that occurred in 16 patients ( 4.5 % ) . Intraprocedural complications , however , decreased to 1 % when angiographically appropriately sized balloons were used for final stent dilations . There was one ischemic vascular complication that occurred at the time of the procedure and one ischemic vascular complication that occurred at the time of angiographic follow-up . By 6 months , repeat angioplasty for symptomatic restenosis was performed in 47 patients ( 13.1 % ) . CONCLUSIONS The Palmaz-Schatz stent can be safely inserted in coronary arteries without subsequent anticoagulation provided that stent expansion is adequate and there are no other flow-limiting lesions present . The use of high-pressure final balloon dilatations and confirmation of adequate stent expansion by intravascular ultrasound provide assurance that anticoagulation therapy can be safely omitted . This technique significantly reduces hospital time and vascular complications and has a low stent thrombosis rate Background —We have previously reported the safety and effectiveness of sirolimus-eluting stents for the treatment of de novo coronary lesions . The present investigation explored the potential of this technology to treat in-stent restenosis . Methods and Results —Twenty-five patients with in-stent restenosis were successfully treated with the implantation of 1 or 2 sirolimus-eluting Bx VELOCITY stents in São Paulo , Brazil . Nine patients received 2 stents ( 1.4 stents per lesion ) . Angiographic and volumetric intravascular ultrasound ( IVUS ) images were obtained after the procedure and at 4 and 12 months . All vessels were patent at the time of 12-month angiography . Angiographic late loss averaged 0.07±0.2 mm in-stent and −0.05±0.3 mm in-lesion at 4 months , and 0.36±0.46 mm in-stent and 0.16±0.42 mm in-lesion after 12 months . No patient had in-stent or stent margin restenosis at 4 months , and only one patient developed in-stent restenosis at 1-year follow-up . Intimal hyperplasia by 3-dimensional IVUS was 0.92±1.9 mm3 at 4 months and 2.55±4.9 mm3 after 1 year . Percent volume obstruction was 0.81±1.7 % and 1.76±3.4 % at the 4- and 12-month follow-up , respectively . There was no evidence of stent malapposition either acutely or in the follow-up IVUS images , and there were no deaths , stent thromboses , or repeat revascularizations . Conclusion —This study demonstrates the safety and the potential utility of sirolimus-eluting Bx VELOCITY stents for the treatment of in-stent restenosis Background —We have previously reported a virtual absence of neointimal hyperplasia 4 months after implantation of sirolimus-eluting stents . The aim of the present investigation was to determine whether these results are sustained over a period of 1 year . Methods and Results —Forty-five patients with de novo coronary disease were successfully treated with the implantation of a single sirolimus-eluting Bx VELOCITY stent in São Paulo , Brazil ( n=30 , 15 fast release [ group I , GI ] and 15 slow release [ GII ] ) and Rotterdam , The Netherl and s ( 15 slow release , GIII ) . Angiographic and volumetric intravascular ultrasound ( IVUS ) follow-up was obtained at 4 and 12 months ( GI and GII ) and 6 months ( GIII ) . In-stent minimal lumen diameter and percent diameter stenosis remained essentially unchanged in all groups ( at 12 months , GI and GII ; at 6 months , GIII ) . Follow-up in-lesion minimal lumen diameter was 2.28 mm ( GIII ) , 2.32 mm ( GI ) , and 2.48 mm ( GII ) . No patient approached the ≥50 % diameter stenosis at 1 year by angiography or IVUS assessment , and no edge restenosis was observed . Neointimal hyperplasia , as detected by IVUS , was virtually absent at 6 months ( 2±5 % obstruction volume , GIII ) and at 12 months ( GI=2±5 % and GII=2±3 % ) . Conclusions —This study demonstrates a sustained suppression of neointimal proliferation by sirolimus-eluting Bx VELOCITY stents 1 year after implantation Background —Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient population s. Methods and Results —We conducted a r and omized , double-blind trial of 536 patients at 38 medical centers evaluating slow-release ( SR ) and moderate-release ( MR ) formulations of a polymer-based paclitaxel-eluting stent ( TAXUS ) for revascularization of single , primary lesions in native coronary arteries . Cohort I compared TAXUS-SR with control stents , and Cohort II compared TAXUS-MR with a second control group . The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound . Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events , a composite of cardiac death , myocardial infa rct ion , and repeat revascularization . At 6 months , percent net volume obstruction within the stent was significantly lower for TAXUS stents ( 7.9 % SR and 7.8 % MR ) than for respective controls ( 23.2 % and 20.5 % ; P < 0.0001 for both ) . This corresponded with a reduction in angiographic restenosis from 17.9 % to 2.3 % in the SR cohort ( P < 0.0001 ) and from 20.2 % to 4.7 % in the MR cohort ( P = 0.0002 ) . The incidence of major adverse cardiac events at 12 months was significantly lower ( P = 0.0192 ) in the TAXUS-SR ( 10.9 % ) and TAXUS-MR ( 9.9 % ) groups than in controls ( 22.0 % and 21.4 % , respectively ) , predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients . Conclusions —Compared with a bare metal stent , paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions Thirty‐two patients presenting with varied coronary syndromes and anatomy were treated with a new coronary multisleeve drug delivery coronary stent ( QuaDS‐QP‐2 ) containing up to 4,000 μg of a taxol‐derived lipophilic microtubule inhibitor ( QP2 ) . The device was successfully implanted in 32 patients who have been followed for up to 2 years . Twenty‐five patients have undergone stress ECHO or SPECT Thallium and all are currently asymptomatic . Thirteen patients have already been restudied angiographically , by IVUS and /or by SPECT Thallium testing and are detailed in this report . Angiographic , IVUS , and SPECT Thallium have been controlled at a mean of 11.2 months ( range , 6–15 months ) in this 13‐patient cohort . Although all 13 QuaDS‐QP‐2 ( QDES ) stents were angiographically and IVUS patent , two re interventions have been required in the 32‐patient study group thus far , both relate to either new disease or to distal , small‐vessel disease beyond the stent . There was no evidence of significant proliferation in the QDES devices . On the basis of this preliminary data and a European pilot study , a controlled r and omized trial ( SCORE ) is currently in progress in western Europe . Cathet Cardiovasc Intervent 2001;53:480–488 . © 2001 Wiley‐Liss , Background —A sirolimus-eluting stent ( Cypher , Cordis Corp ) has been reported to markedly decrease restenosis in selected lesions ; higher-risk lesions , including coronary bifurcations , have not been studied . Methods and Results —This prospect i ve study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions . Patients were r and omly assigned to either stenting of both branches ( group A ) or stenting of the main branch with provisional stenting of the side branch ( SB ) ( group B ) . Eighty-five patients ( 86 lesions ) were enrolled . There was 1 case of unsuccessful delivery of any device at the bifurcation site . Given the high crossover , more lesions were treated with 2 stents ( n=63 ) than with stent/balloon ( n=22 ) . Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A ( 85.5 % ) and 21 in group B ( 95.4 % ) . One patient died suddenly 4.5 months after the procedure . There were 3 cases of stent thrombosis ( 3.5 % ) . The total restenosis rate at 6 months was 25.7 % , and it was not significantly different between the double-stenting ( 28.0 % ) and the provisional SB-stenting ( 18.7 % ) groups . Fourteen of the restenosis cases occurred at the ostium of the SB and were focal . Target lesion revascularization was performed in 7 cases ; target vessel failure occurred in 15 cases ( 17.6 % ) . Conclusions —These results are an improvement compared with historical controls using bare metal stents . Restenosis at the SB remains a problem . At this time , no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent Background —The first clinical study of paclitaxel-eluting stent for de novo lesions showed promising results . We performed the TAXUS III trial to evaluate the feasibility and safety of paclitaxel-eluting stent for the treatment of in-stent restenosis ( ISR ) . Methods and Results —The TAXUS III trial was a single-arm , 2-center study that enrolled 28 patients with ISR meeting the criteria of lesion length ≤30 mm , 50 % to 99 % diameter stenosis , and vessel diameter 3.0 to 3.5 mm . They were treated with one or more TAXUS NIRx paclitaxel-eluting stents . Twenty-five patients completed the angiographic follow-up at 6 months , and 17 of these underwent intravascular ultrasound ( IVUS ) examination . No subacute stent thrombosis occurred up to 12 months , but there was one late chronic total occlusion , and additional 3 patients showed angiographic restenosis . The mean late loss was 0.54 mm , with neointimal hyperplasia volume of 20.3 mm3 . The major adverse cardiac event rate was 29 % ( 8 patients ; 1 non-Q-wave myocardial infa rct ion , 1 coronary artery bypass grafting , and 6 target lesion revascularization [ TLR ] ) . Of the patients with TLR , 1 had restenosis in a bare stent implanted for edge dissection and 2 had restenosis in a gap between 2 paclitaxel-eluting stents . Two patients without angiographic restenosis underwent TLR as a result of the IVUS assessment at follow-up ( 1 incomplete apposition and 1 insufficient expansion of the stent ) . Conclusions —Paclitaxel-eluting stent implantation is considered safe and potentially efficacious in the treatment of ISR . IVUS guidance to ensure good stent deployment with complete coverage of target lesion may reduce reintervention Background —Early results of sirolimus-eluting stent implantation showed a nearly complete abolition of neointimal hyperplasia . The question remains , however , whether the early promising results will still be evident at long-term follow-up . The objective of our study was to evaluate the efficiency of sirolimus-eluting stent implantation for up to 2 years of follow-up . Methods and Results —Fifteen patients with de novo coronary artery disease were treated with 18-mm sirolimus-eluting Bx-Velocity stents ( Cordis ) loaded with 140 & mgr;g sirolimus/cm2 metal surface area in a slow release formulation . Quantitative angiography ( QCA ) and intravascular ultrasound ( IVUS ) were performed according to st and ard protocol . Sirolimus-eluting stent implantation was successful in all 15 patients . During the in-hospital course , 1 patient died of cerebral hemorrhage after periprocedural administration of abciximab , and 1 patient underwent repeat stenting after 2 hours because of edge dissection that led to acute occlusion . Through 6 months and up to 2 years of follow-up , no additional events occurred . QCA analysis revealed no significant change in stent minimal lumen diameter or percent diameter stenosis , and 3-dimensional IVUS showed no significant deterioration in lumen volume . In 2 patients , additional stenting was performed because of significant lesion progression remote from the sirolimus-eluting stent . Conclusion —Sirolimus-eluting stents showed persistent inhibition of neointimal hyperplasia for up to 2 years of follow-up BACKGROUND Sirolimus-eluting stents have been developed to prevent restenosis in the treatment of coronary artery disease . We investigated the risk of restenosis with use of sirolimus-eluting stents compared with bare-metal stents to assess possible differences . METHODS We enrolled 352 patients in whom one coronary artery required treatment , with diameter 2.5 - 3.0 mm and lesion length 15 - 32 mm . We r and omly assigned patients sirolimus-eluting stents ( n=175 ) or bare-metal stents ( control , n=177 ) . At 8 months we assessed differences in minimum lumen diameter and binary restenosis within the lesion ( restenosis of > or = 50 % diameter , including 5 mm vessel segments proximal and distal to stented segment ) . Patients were also followed up for 9 months for major adverse cardiac events . Analysis was by intention to treat . FINDINGS Stent implantation was successful in 100 % of sirolimus-stent patients and 99.4 % of controls . The mean diameter of treated coronary arteries was 2.55 mm ( SD 0.37 ) and mean lesion length was 15.0 mm ( 6.0 ) . Multiple stents were implanted in 170 ( 48 % ) patients . At 8 months , minimum lumen diameter was significantly higher with sirolimus-eluting stents than with control stents ( 2.22 vs 1.33 mm , p<0.0001 ) . The rate of binary restenosis was significantly reduced with sirolimus-eluting stents compared with control stents ( 5.9 vs 42.3 % , p=0.0001 ) . Significantly fewer patients with sirolimus-eluting stents had major adverse cardiac events at 9 months than did controls ( 8.0 vs 22.6 % , p=0.0002 ) , due mainly to a lower need for target-lesion revascularisations ( 4.0 vs 20.9 % , p<0.0001 ) . INTERPRETATION Sirolimus-eluting stents are better than bare-metal stents for treatment of single long atherosclerotic lesions in a coronary vessel smaller than 3 mm in diameter OBJECTIVES We assessed the safety and effectiveness of the sirolimus-eluting stent ( SES ) in treating single de novo long lesions in small native coronary arteries compared to an identical bare metal stent ( BMS ) . BACKGROUND The SES was previously demonstrated to reduce restenosis significantly . However , patients with long lesions in small vessels have not been well studied and may define a group at very high risk . METHODS The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients With Long De Novo Lesions in Small Native Coronary Arteries ( C-SIRIUS ) was a multicenter , r and omized , double-blind trial comparing SES versus identical BMS . The primary end point was in-stent minimal lumen diameter ( MLD ) at eight months . Secondary end points included angiographic restenosis at 8 months , target lesion revascularization ( TLR ) , and major adverse cardiac events ( MACE ) at 270 days . RESULTS A total of 100 patients were enrolled at eight Canadian sites . The in-stent MLD at eight months was 2.46 + /- 0.37 mm in the SES compared with 1.49 + /- 0.75 mm in the BMS ( a 65 % increase , p < 0.001 ) . Angiographic restenosis occurred in 1 of 44 SES patients ( 2.3 % , with no in-stent restenosis ) and in 23 of 44 BMS patients ( 52.3 % , p < 0.001 ) . At 270 days , there were two clinical ly driven TLRs in the SES ( 4 % ) and nine in the BMS ( 18 % , p = 0.05 ) . The Kaplan-Meier estimate of freedom from MACE at 270 days was 96.0 % for SES patients and 81.7 % for BMS patients ( p = 0.029 ) . CONCLUSIONS Patients with long lesions in small vessels are at very high risk of restenosis . In these patients , the SES dramatically reduces the risk of restenosis at eight months , translating into an excellent clinical outcome at nine months BACKGROUND The need for repeated treatment of restenosis of a treated vessel remains the main limitation of percutaneous coronary revascularization . Because sirolimus ( rapamycin ) inhibits the proliferation of lymphocytes and smooth-muscle cells , we compared a sirolimus-eluting stent with a st and ard uncoated stent in patients with angina pectoris . METHODS We performed a r and omized , double-blind trial to compare the two types of stents for revascularization of single , primary lesions in native coronary arteries . The trial included 238 patients at 19 medical centers . The primary end point was in-stent late luminal loss ( the difference between the minimal luminal diameter immediately after the procedure and the diameter at six months ) . Secondary end points included the percentage of in-stent stenosis of the luminal diameter and the rate of restenosis ( luminal narrowing of 50 percent or more ) . We also analyzed a composite clinical end point consisting of death , myocardial infa rct ion , and percutaneous or surgical revascularization at 1 , 6 , and 12 months . RESULTS At six months , the degree of neointimal proliferation , manifested as the mean ( + /-SD ) late luminal loss , was significantly lower in the sirolimus-stent group ( -0.01+/-0.33 mm ) than in the st and ard-stent group ( 0.80+/-0.53 mm , P<0.001 ) . None of the patients in the sirolimus-stent group , as compared with 26.6 percent of those in the st and ard-stent group , had restenosis of 50 percent or more of the luminal diameter ( P<0.001 ) . There were no episodes of stent thrombosis . During a follow-up period of up to one year , the overall rate of major cardiac events was 5.8 percent in the sirolimus-stent group and 28.8 percent in the st and ard-stent group ( P<0.001 ) . The difference was due entirely to a higher rate of revascularization of the target vessel in the st and ard-stent group . CONCLUSIONS As compared with a st and ard coronary stent , a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation , restenosis , and associated clinical events BACKGROUND Preliminary reports of studies involving simple coronary lesions indicate that a sirolimus-eluting stent significantly reduces the risk of restenosis after percutaneous coronary revascularization . METHODS We conducted a r and omized , double-blind trial comparing a sirolimus-eluting stent with a st and ard stent in 1058 patients at 53 centers in the United States who had a newly diagnosed lesion in a native coronary artery . The coronary disease in these patients was complex because of the frequent presence of diabetes ( in 26 percent of patients ) , the high percentage of patients with longer lesions ( mean , 14.4 mm ) , and small vessels ( mean , 2.80 mm ) . The primary end point was failure of the target vessel ( a composite of death from cardiac causes , myocardial infa rct ion , and repeated percutaneous or surgical revascularization of the target vessel ) within 270 days . RESULTS The rate of failure of the target vessel was reduced from 21.0 percent with a st and ard stent to 8.6 percent with a sirolimus-eluting stent (P<0.001)--a reduction that was driven largely by a decrease in the frequency of the need for revascularization of the target lesion ( 16.6 percent in the st and ard-stent group vs. 4.1 percent in the sirolimus-stent group , P<0.001 ) . The frequency of neointimal hyperplasia within the stent was also decreased in the group that received sirolimus-eluting stents , as assessed by both angiography and intravascular ultrasonography . Subgroup analyses revealed a reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined . CONCLUSIONS In this r and omized clinical trial involving patients with complex coronary lesions , the use of a sirolimus-eluting stent had a consistent treatment effect , reducing the rates of restenosis and associated clinical events in all subgroups analyzed |
1,397 | 29,096,418 | Several findings were consistent with a comparable meta- analysis in adult oncology population s. Targeted social support , clinical intervention , and education may facilitate post-traumatic growth . | OBJECTIVE A growing number of children and adolescents are experiencing and surviving cancer .
This review aims to identify the demographic , medical , and psychosocial correlates of perceived post-traumatic growth in individuals of any age who were affected by paediatric cancer .
Findings will highlight protective factors that may facilitate post-traumatic growth , allowing for directed social support , intervention , and follow-up care . | OBJECTIVE To describe posttraumatic growth ( PTG ) following childhood cancer survival and its association with demographic and disease/treatment variables , perceived treatment severity and life threat , and posttraumatic stress symptoms ( PTSS ) . METHOD Adolescent survivors of cancer ( N = 150 , ages 11 - 19 ) , at least 1 year after treatment , and their mothers ( N = 146 ) and fathers ( N = 107 ) completed self-report measures of perceived treatment intensity and PTSS and a semistructured interview design ed to identify posttraumatic responses and indicators of PTG including perceived positive changes for self , relationships , and life goals . RESULTS A majority of adolescents and their mothers and fathers reported PTG . Greater perceived treatment severity and life threat , but not objective disease severity , was associated with PTG . PTG and PTSS were positively associated for the adolescent cancer survivors . Diagnosis after age 5 result ed in more perceived benefit and greater PTSS for adolescent survivors . CONCLUSION Clarification of the concept and measurement of PTG after childhood cancer is warranted , as are prospect i ve studies of the association of PTG and PTSS and the role of demographic variables and illness-specific appraisal The correlates and consequences of benefit finding on quality of life were examined for 364 women ( 93 % Caucasian , 6 % African American , and 1 % Hispanic ) diagnosed with Stage I , II , and III breast cancer . Benefit finding and quality of life were measured 4 months postdiagnosis ( Tl ) , 3 months after Tl ( T2 ) , and 6 months after T2 ( T3 ) . Women with lower socioeconomic status , minorities , and those with more severe disease perceived more benefits at baseline . Benefit finding was associated with more negative affect at baseline and also interacted with stage of disease , such that negative relations to quality of life across time were limited to those with more severe disease . Findings suggest there are qualifiers as to whether " finding something good in the bad " is good or bad CONTEXT Adult survivors of childhood cancer are at risk for medical and psychosocial sequelae that may adversely affect their health status . OBJECTIVES To compare the health status of adult survivors of childhood cancer and siblings and to identify factors associated with adverse outcomes . DESIGN , SETTING , AND PARTICIPANTS Health status was assessed in 9535 adult participants of the Childhood Cancer Survivor Study , a cohort of long-term survivors of childhood cancer who were diagnosed between 1970 and 1986 . A r and omly selected cohort of the survivors ' siblings ( n = 2916 ) served as a comparison group . MAIN OUTCOME MEASURES Six health status domains were assessed : general health , mental health , functional status , activity limitations , cancer-related pain , and cancer-related anxiety/fears . The first 4 domains were assessed in the control group . RESULTS Survivors were significantly more likely to report adverse general health ( odds ratio [ OR ] , 2.5 ; 95 % confidence interval [ CI ] , 2.1 - 3.0 ; P<.001 ) , mental health ( OR , 1.8 ; 95 % CI , 1.6 - 2.1 ; P<.001 ) , activity limitations ( OR , 2.7 ; 95 % CI , 2.3 - 3.3 ; P<.001 ) , and functional impairment ( OR , 5.2 ; 95 % CI , 4.1 - 6.6 ; P<.001 ) , compared with siblings . Forty-four percent of survivors reported at least 1 adversely affected health status domain . Sociodemographic factors associated with reporting at least 1 adverse health status domain included being female ( OR , 1.4 ; 95 % CI , 1.3 - 1.6 ; P<.001 ) , lower level of educational attainment ( OR , 2.0 ; 95 % CI , 1.8 - 2.2 ; P<.001 ) , and annual income less than 20 000 dollars ( OR , 1.8 ; 95 % CI , 1.6 - 2.1 ; P<.001 ) . Relative to those survivors with childhood leukemia , an increased risk was observed for at least 1 adverse health status domain among those with bone tumors ( OR , 2.1 ; 95 % CI , 1.8 - 2.5 ; P<.001 ) , central nervous system tumors ( OR , 1.7 ; 95 % CI , 1.5 - 2.0 ; P<.001 ) , and sarcomas ( OR , 1.2 ; 95 % CI , 1.1 - 1.5 ; P = .01 ) . CONCLUSION Clinicians caring for adult survivors of childhood cancer should be aware of the substantial risk for adverse health status , especially among females , those with low educational attainment , and those with low household incomes OBJECTIVE In order to broaden the view beyond posttraumatic stress disorder ( PTSD ) in children , we examined to what extent posttraumatic stress reactions , posttraumatic growth , and quality of life were related to each other and to traumatic exposure in the general population . METHOD 1770 children of 36 r and omly selected primary schools ( mean age = 10.24 years , 50 % boys ) reported in October/November 2006 on their worst experience ( traumatic exposure was considered present when the described event fulfilled the A1 criterion for PTSD of the DSM-IV-TR ) and filled out the Children 's Responses to Trauma Inventory , the Posttraumatic Growth Inventory for Children , and the KIDSCREEN-27 . Correlational and hierarchical linear regression analyses were carried out in a multiple imputation format . RESULTS Posttraumatic stress reactions were strongly related to posttraumatic growth ( r = 0.41 , p < .01 ) and quality of life ( r = -0.47 , p < .01 ) . The latter 2 variables were weakly related ; positively when controlling for posttraumatic stress reactions ( r = 0.09 , p < .01 ) , negatively when not ( r = -0.12 , p < .01 ) . Children who were exposed to trauma reported more posttraumatic stress reactions ( β = .12 , p < .01 ) , more posttraumatic growth ( β = .09 , p < .01 ) , and less quality of life ( β = -.08 , p < .01 ) than nonexposed children ( effect sizes were small ) . CONCLUSIONS Negative and positive psychological sequelae of trauma can coexist in children , and extend to broader areas of life than specific symptoms only . Clinicians should look further than PTSD alone and pay attention to the broad range of posttraumatic stress reactions that children show , their experience of posttraumatic growth , and their quality of life Psychological reactions to having had childhood cancer often continue after treatment ends , for survivors and their parents . Based on our previous research , we developed an intervention program for adolescent survivors of childhood cancer , their parents , and siblings . Surviving Cancer Competently : An Intervention Program -- SCCIP -- is a one-day family group intervention that combines cognitive-behavioral and family therapy approaches . The goals of SCCIP are to reduce symptoms of distress and to improve family functioning and development . SCCIP is described and data from a pilot study of 19 families are presented . Program evaluation data indicated that all family members found SCCIP helpful . St and ardized measures administered before the intervention and again at 6 months after SCCIP showed that symptoms of posttraumatic stress and anxiety decreased . Changes in family functioning were more difficult to discern . Overall , the results were promising with regard to the feasibility of the program and its potential for reducing symptoms of distress for all family members |
1,398 | 18,093,337 | Conclusion The act of taking a pill placebo may enhance the placebo effect already contained in the effective psychotherapeutic intervention during the acute phase treatment .
Theoretically this is an argument against the recently cl aim ed null hypothesis of placebo effect in general and clinical ly it may point to some further room for enhancing the psychotherapeutic approach for panic disorder | Background In a number of drug and psychotherapy comparative trials , psychotherapy-placebo combination has been assumed to represent psychotherapy .
Whether psychotherapy plus pill placebo is the same as psychotherapy alone is an empirical question which however has to date never been examined systematic ally . | OBJECTIVE To address the lack of a simple and st and ardized instrument to assess overall panic disorder severity , the authors developed a scale for the measurement of panic disorder severity . METHOD Ten independent evaluators used the seven-item Panic Disorder Severity Scale to assess 186 patients with principal DSM-III-R diagnoses of panic disorder ( with no or mild agoraphobia ) who were participating in the Multicenter Collaborative Treatment Study of Panic Disorder . In addition , 89 of these patients were reevaluated with the same scale after short-term treatment . A subset of 24 patients underwent two independent assessment s to establish interrater reliability . Internal consistency , convergent and discriminant validity , and sensitivity to change were also determined . RESULTS The Panic Disorder Severity Scale was associated with excellent interrater reliability , moderate internal consistency , and favorable levels of validity and sensitivity to change . Individual items showed good convergent and discriminant validity . Analysis suggested a two-factor model fit the data best . CONCLUSIONS The Panic Disorder Severity Scale is a simple , efficient way for clinicians to rate severity in patients with established diagnoses of panic disorder . However , further research with more diverse groups of panic disorder patients and with a broader range of convergent and discriminant validity measures is needed OBJECTIVE Recent studies have suggested that most patients treated for panic disorder receive forms of psychotherapy other than cognitive behavior therapy , even though there is little information about the efficacy of such treatments or how they compare to proven active treatments . The authors compared one of these other forms , emotion-focused psychotherapy ( given to 30 patients with panic disorder ) , to results obtained with recommended st and ard treatment ( either cognitive behavior therapy [ N=36 ] or imipramine [ N=22 ] ) . The authors also compared emotion-focused psychotherapy to results obtained in subjects given pill placebo ( N=24 ) . METHOD Subjects met DSM-IV criteria for panic disorder with no more than mild agoraphobia . Treatment consisted of approximately 3 months of weekly visits followed by 6 monthly maintenance visits . Assessment s were conducted after each treatment phase and at a follow-up visit after 6 months of no treatment . RESULTS Emotion-focused psychotherapy was less effective for symptoms of panic disorder than treatment with either cognitive behavior therapy or imipramine ; results obtained with emotion-focused psychotherapy after the acute and maintenance phases were similar to those seen with placebo . Treatment expectations were not different among the different groups . Patients receiving emotion-focused psychotherapy had the highest completion rate . CONCLUSIONS The results suggest that emotion-focused psychotherapy ( a supportive form of psychotherapy ) has low efficacy for the treatment of panic disorder . However , emotion-focused psychotherapy may be superior to medical management in helping patients stay in treatment CONTEXT Panic disorder ( PD ) may be treated with drugs , psychosocial intervention , or both , but the relative and combined efficacies have not been evaluated in an unbiased fashion . OBJECTIVE To evaluate whether drug and psychosocial therapies for PD are each more effective than placebo , whether one treatment is more effective than the other , and whether combined therapy is more effective than either therapy alone . DESIGN AND SETTING R and omized , double-blind , placebo-controlled clinical trial conducted in 4 anxiety research clinics from May 1991 to April 1998 . PATIENTS A total of 312 patients with PD were included in the analysis . INTERVENTIONS Patients were r and omly assigned to receive imipramine , up to 300 mg/d , only ( n=83 ) ; cognitive-behavioral therapy ( CBT ) only ( n=77 ) ; placebo only ( n=24 ) ; CBT plus imipramine ( n=65 ) ; or CBT plus placebo ( n=63 ) . Patients were treated weekly for 3 months ( acute phase ) ; responders were then seen monthly for 6 months ( maintenance phase ) and then followed up for 6 months after treatment discontinuation . MAIN OUTCOME MEASURES Treatment response based on the Panic Disorder Severity Scale ( PDSS ) and the Clinical Global Impression Scale ( CGI ) by treatment group . RESULTS Both imipramine and CBT were significantly superior to placebo for the acute treatment phase as assessed by the PDSS ( response rates for the intent-to-treat [ ITT ] analysis , 45.8 % , 48.7 % , and 21.7 % ; P=.05 and P=.03 , respectively ) , but were not significantly different for the CGI ( 48 . 2 % , 53.9 % , and 37.5 % , respectively ) . After 6 months of maintenance , imipramine and CBT were significantly more effective than placebo for both the PDSS ( response rates , 37.8 % , 39.5 % , and 13.0 % , respectively ; P=.02 for both ) and the CGI ( 37.8 % , 42.1 % , and 13.0 % , respectively ) . Among responders , imipramine produced a response of higher quality . The acute response rate for the combined treatment was 60.3 % for the PDSS and 64.1 % for the CGI ; neither was significantly different from the other groups . The 6-month maintenance response rate for combined therapy was 57.1 % for the PDSS ( P=.04 vs CBT alone and P=.03 vs imipramine alone ) and 56.3 % for the CGI ( P=.03 vs imipramine alone ) , but not significantly better than CBT plus placebo in either analysis . Six months after treatment discontinuation , in the ITT analysis CGI response rates were 41.0 % for CBT plus placebo , 31.9 % for CBT alone , 19.7 % for imipramine alone , 13 % for placebo , and 26.3 % for CBT combined with imipramine . CONCLUSIONS Combining imipramine and CBT appeared to confer limited advantage acutely but more substantial advantage by the end of maintenance . Each treatment worked well immediately following treatment and during maintenance ; CBT appeared durable in follow-up . JAMA . 2000;283:2529 - OBJECTIVE The purpose of this comparative outcome study was to investigate whether the effects of exposure in vivo treatment for panic disorder with agoraphobia could be enhanced by adding interventions specifically for panic attacks before the start of exposure treatment . The additional effect of two types of treatment for panic attacks -- pharmacological ( fluvoxamine ) and psychological ( repeated hyperventilation provocations and respiratory training)--was examined . Thus , the combined treatment of panic interventions with exposure in vivo could be compared to exposure in vivo alone . METHOD Ninety-six patients were r and omly assigned to four treatment conditions : double-blind , placebo-controlled fluvoxamine followed by exposure in vivo , psychological panic management followed by exposure , and exposure in vivo alone . Outcome was assessed by self-report measures , a st and ardized multitask behavioral avoidance test , and continuous monitoring of panic attacks . Seventy-six patients completed the study . RESULTS All four treatments were effective and result ed in a significant decrease of agoraphobic avoidance . Moreover , the combination of fluvoxamine and exposure in vivo demonstrated efficacy superior to that of the other treatments and had twice as large an effect size ( difference between pre- and posttreatment scores ) on self-reported agoraphobic avoidance . The other treatments did not differ among each other in effectiveness . CONCLUSIONS Results of the study indicate that the short-term outcome of exposure in vivo treatment can be enhanced by adding fluvoxamine treatment . Psychological panic management combined with exposure was not superior to exposure alone of equal duration |
1,399 | 26,245,769 | These findings suggest that MPV may be a useful prognostic marker in patients with CAD | Large platelets with high haemostatic activity may lead to increased platelet aggregation .. Mean platelet volume ( MPV ) , an indicator of platelet reactivity , may emerge as a prognostic marker in patients with coronary artery disease ( CAD ) .
It was the objective of this study to conduct a systematic review and meta- analysis to assess prognostic effects of MPV on cardiovascular events ( CVE ) in CAD patients . | A high platelet turnover rate produce a population of immature reticulated platelets ( RP ) that could confer , despite of antiplatelet drugs , a residual platelet reactivity ( RPR ) in coronary artery disease ( CAD ) patients . To assess the influence of RP on platelet reactivity in CAD patients on dual antiplatelet therapy we measured RP in 372 patients by using the Sysmex XE-2100 haematology analyzer and platelet function by optical platelet aggregometry ( PA ) on platelet-rich-plasma induced by 1 mmol arachidonic acid ( AA-PA ) and 10 microM ADP ( ADP-PA ) . RPR was defined as either AA-PA>20 % or ADP-PA>70 % . RP were expressed as a percentage of RP of the total optical platelet count ( immature platelet fraction ; IPF ) and as the percentage of RP highly fluorescent ( highly fluorescent immature platelet fraction ; H-IPF ) . Moderate but significant positive correlations between PA , IPF , H-IPF , and mean platelet volume ( MPV ) were found . According to tertiles of IPF , H-IPF and MPV , a significant trend for an increase of platelet aggregation by AA and ADP was evidence d. Furthermore , a significant difference for IPF , H-IPF and MPV between patients with and without RPR was observed . A linear regression analysis showed that IPF , H-IPF and MPV significantly affected PA measured by AA and ADP . At multivariate linear regression analysis these associations were confirmed . Moreover , a logistic regression analysis demonstrated that IPF , H-IPF and MPV significantly influenced the risk of RPR , and in the multivariate model these results remained significant . This study indicates that a high rate of platelet turnover is a new mechanism associated with platelet reactivity in high risk CAD patients on dual antiplatelet therapy BACKGROUND Mean platelet volume ( MPV ) is a strong predictor of impaired angiographic reperfusion and 6-month mortality in ST-elevation myocardial infa rct ion ( MI ) treated with primary percutaneous coronary intervention ( PCI ) . No data is available for other platelet volume indices : platelet distribution width ( PDW ) and platelet large cell ratio ( P-LCR ) . The aim was to assess the impact of 3 platelet volume indices on long-term prognosis in patients treated with primary PCI in acute MI . METHODS This prospect i ve study enrolled 538 patients who underwent primary PCI in acute MI . Admission blood sample s were measured for MPV , PDW , and P-LCR . The patients were followed-up a mean period of 26 ± 11 months with regard to cardiac death , non-fatal reinfa rct ion , re-PCI or coronary artery bypass grafting . RESULTS Kaplan-Meier survival analysis showed a significantly higher 26-month mortalityrate in patients with high MPV ( ≥ 11.7 fL ) than in those with low MPV ( < 11.7 fL ) ( 14.6 % vs. 5.5 % , p = 0.0008 ) . Similar findings were related to high P-LCR ( ≥ 38.1 % ) vs. low P-LCR ( < 38.1 % ) - mortality 13.8 % vs. 5.8 % , p = 0.0025 . Higher PDW values ( ≥ 16 fL ) correlated with higher mortality rate as compared to PDW < 16 fL ( 17.4 % vs. 6.3 % , p = 0.0012 ) . PDW was found to be an independent prognostic factor for cardiac mortality and composite endpoint . CONCLUSIONS Mean platelet volume , platelet distribution width and platelet large cell ratio measured on admission are strong , independent prognostic factors in PCI-treated acute MI CONTEXT Patients with unstable angina/non-ST-segment elevation myocardial infa rct ion ( MI ) ( UA/NSTEMI ) present with a wide spectrum of risk for death and cardiac ischemic events . OBJECTIVE To develop a simple risk score that has broad applicability , is easily calculated at patient presentation , does not require a computer , and identifies patients with different responses to treatments for UA/NSTEMI . DESIGN , SETTING , AND PATIENTS Two phase 3 , international , r and omized , double-blind trials ( the Thrombolysis in Myocardial Infa rct ion [ TIMI ] 11B trial [ August 1996-March 1998 ] and the Efficacy and Safety of Subcutaneous Enoxaparin in Unstable Angina and Non-Q-Wave MI trial [ ESSENCE ; October 1994-May 1996 ] ) . A total of 1957 patients with UA/NSTEMI were assigned to receive unfractionated heparin ( test cohort ) and 1953 to receive enoxaparin in TIMI 11B ; 1564 and 1607 were assigned respectively in ESSENCE . The 3 validation cohorts were the unfractionated heparin group from ESSENCE and both enoxaparin groups . MAIN OUTCOME MEASURES The TIMI risk score was derived in the test cohort by selection of independent prognostic variables using multivariate logistic regression , assignment of value of 1 when a factor was present and 0 when it was absent , and summing the number of factors present to categorize patients into risk strata . Relative differences in response to therapeutic interventions were determined by comparing the slopes of the rates of events with increasing score in treatment groups and by testing for an interaction between risk score and treatment . Outcomes were TIMI risk score for developing at least 1 component of the primary end point ( all-cause mortality , new or recurrent MI , or severe recurrent ischemia requiring urgent revascularization ) through 14 days after r and omization . RESULTS The 7 TIMI risk score predictor variables were age 65 years or older , at least 3 risk factors for coronary artery disease , prior coronary stenosis of 50 % or more , ST-segment deviation on electrocardiogram at presentation , at least 2 anginal events in prior 24 hours , use of aspirin in prior 7 days , and elevated serum cardiac markers . Event rates increased significantly as the TIMI risk score increased in the test cohort in TIMI 11B : 4.7 % for a score of 0/1 ; 8.3 % for 2 ; 13 . 2 % for 3 ; 19.9 % for 4 ; 26.2 % for 5 ; and 40.9 % for 6/7 ( P<.001 by chi(2 ) for trend ) . The pattern of increasing event rates with increasing TIMI risk score was confirmed in all 3 validation groups ( P<.001 ) . The slope of the increase in event rates with increasing numbers of risk factors was significantly lower in the enoxaparin groups in both TIMI 11B ( P = .01 ) and ESSENCE ( P = .03 ) and there was a significant interaction between TIMI risk score and treatment ( P = . 02 ) . CONCLUSIONS In patients with UA/NSTEMI , the TIMI risk score is a simple prognostication scheme that categorizes a patient 's risk of death and ischemic events and provides a basis for therapeutic decision making . JAMA . 2000;284:835 - Data from the Diet and Reinfa rct ion Trial were examined to check the prognostic effects of plasma fibrinogen , plasma viscosity , white blood cell count , haemoglobin and mean platelet volume in 92 deaths among 1755 men who had recently recovered from acute myocardial infa rct ion . All these variables were significantly associated with all-cause mortality over the following 18 months ( haemoglobin negatively , the others positively ) . Those who gave up smoking following their infa rct had a lower mortality than those who continued to smoke ( 4.1 % and 7.9 % respectively ) , and this effect appeared to be mediated by fibrinogen levels . Smoking habit accounted for only part of the prognostic effect of fibrinogen and white blood cell count . Haematological variables have an important prognostic significance after myocardial infa rct ion . Cessation of smoking after myocardial infa rct ion is worthwhile and has a favourable effect on plasma fibrinogen Mean platelet volume ( MPV ) has been proposed as a marker of platelet reactivity and cardiovascular risk . Its prognostic significance has not been thoroughly investigated in patients with non-ST elevation acute coronary syndrome ( NSTE-ACS ) . We included 1,041 consecutive patients with NSTE-ACS . Patients were divided in quartiles according to the MPV value on admission ( fl ) i.e. Q1<7.5 ; Q2=7.5 - 8.0 ; Q3=8.1 - 8.8 ; Q4≥8.9 . The primary study endpoint was the composite of cardiovascular death and re-myocardial infa rct ion ( MI ) at one year . Secondary study endpoints were individual cardiovascular death and re-MI . Patients in Q4 were older , had a higher prevalence of previous MI , peripheral artery disease and advanced Killip class compared to patients in Q1-Q3 . Elevated MPV levels ( Q4 ) was independently associated with gender , smoking status , platelet count and creatinine level . Overall , 210 patients ( 20.2 % ) reached the primary endpoint , 124 ( 12.1 % ) died from cardiovascular causes and 125 ( 12.0 % ) suffered from re-MI . On multivariable analysis patients in Q4 were at higher risk of primary endpoint ( HR=1.41 ; 95%CI 1.06 - 1.89 ; p=0.02 ) whilst the association with cardiovascular death and re-MI was attenuated . MPV as continuous variable was independently associated with both primary endpoint ( HR=1.19 ; 95%CI 1.06 - 1.33 ; p=0.003 ) and cardiovascular death ( HR=1.23 ; 95%CI 1.06 - 1.42 , p=0.006 ) . The incorporation of MPV into a comprehensive model of risk significantly increased the likelihood ratio chi-square for prediction of both the composite endpoint ( p=0.004 ) and cardiovascular death ( p=0.009 ) . Therefore , MPV may be useful to improve risk stratification in NSTE-ACS patients and should be included in future prospect i ve studies evaluating the role of platelet function in promoting cardiovascular events BACKGROUND Appropriate treatment policies should include an accurate estimate of a patient 's baseline risk . Risk modeling to date has been underutilized in patients with acute coronary syndromes without persistent ST-segment elevation . METHODS AND RESULTS We analyzed the relation between baseline characteristics and the 30-day incidence of death and the composite of death or myocardial (re)infa rct ion in 9461 patients with acute coronary syndromes without persistent ST-segment elevation enrolled in the PURSUIT trial [ Platelet glycoprotein IIb/IIIa in Unstable angina : Receptor Suppression Using Integrilin ( eptifibatide ) Therapy ] . Variables examined included demographics , history , hemodynamic condition , and symptom duration . Risk models were created with multivariable logistic regression and vali date d by bootstrapping techniques . There was a 3.6 % mortality rate and 11.4 % infa rct ion rate by 30 days . More than 20 significant predictors for mortality and for the composite end point were identified . The most important baseline determinants of death were age ( adjusted chi(2)=95 ) , heart rate ( chi(2)=32 ) , systolic blood pressure ( chi(2)=20 ) , ST-segment depression ( chi(2)=20 ) , signs of heart failure ( chi(2)=18 ) , and cardiac enzymes ( chi(2)=15 ) . Determinants of mortality were generally also predictive of death or myocardial (re)infa rct ion . Differences were observed , however , in the relative prognostic importance of predictive variables for mortality alone or the composite end point ; for example , sex was a more important determinant of the composite end point ( chi(2)=21 ) than of death alone ( chi(2)=10 ) . The accuracy of the prediction of the composite end point was less than that of mortality ( C-index 0.67 versus 0.81 ) . CONCLUSIONS The occurrence of adverse events after presentation with acute coronary syndromes is affected by multiple factors . These factors should be considered in the clinical decision-making process A prospect i ve study was performed to investigate the role of the endogenous fibrinolytic system and platelet function for the occurrence of reocclusion after successful recanalization of chronic coronary occlusions . At control coronary angiography 8 + /- 2 weeks after recanalization , reocclusion was found in 10 ( 21 % ) of 47 patients . After correction for angiographic and clinical confounding factors , endogenous concentrations of tissue plasminogen activator ( TPA ) were lower in patients with reocclusion than in patients without . In contrast , plasma levels of plasminogen activator inhibitor-1 and alpha 2-antiplasmin were similar in the two groups . The mean platelet volume was significantly higher in patients with reocclusion than in patients without . In addition , agonist-induced platelet aggregation in platelet-rich plasma was enhanced in the patients with reocclusion . Decreased endogenous plasma TPA concentrations and enhanced platelet reactivity may contribute to the occurrence of reocclusion after primarily successful coronary artery recanalization Mean platelet volume ( MPV ) is a value that is available from st and ard blood count . Increased MPV is associated with increased platelet reactivity and it has been correlated with adverse cardiac outcomes in patients with acute coronary syndromes ( ACS ) . However , there is limited information about the prognostic value of baseline MPV in a large heterogenous patient population which undergoes percutaneous coronary intervention ( PCI ) . To examine whether baseline MPV is predictive of clinical outcomes in patients who undergo PCI . Included were consecutive patients who underwent PCI during 2004–2010 ( n = 7,585 , mean age 67.7 ± 12.1 years , 76.0 % males ) with a median follow-up period of 4 years . Baseline MPV before angiography and long-term clinical outcomes were assessed . The mean MPV was higher in women as compared to men ( 8.6 ± 1.2 vs. 8.5 ± 1.1 fL , p = 0.02 ) , in diabetic versus non-diabetic patients ( 8.6 ± 1.2 vs. 8.4 ± 1.1 fL , p < 0.001 ) and in patients who were admitted with ACS ( n = 4,961 ) compared to patients who underwent an elective PCI ( 8.6 ± 1.1 vs. 8.5 ± 1.1 fL , p = 0.001 ) . On multivariate analysis , MPV was associated with mortality ( HR 1.18 , 95 % CI 1.12–1.23 , p < 0.001 ) and with a composite end-point of death , MI and target vessel revascularization ( HR 1.09 , 95 % CI 1.04–1.13 , p < 0.001 ) . Baseline MPV was associated with mortality in patients undergoing an elective PCI as well as in urgent PCI ( HR 1.30 , 95 % CI 1.20–1.40 , p < 0.001 and HR 1.13 , 95 % CI 1.07–1.20 , p < 0.001 , respectively ) . In patients undergoing either an elective or urgent PCI , an elevated MPV is a significant predictor of cardiovascular adverse events including death Reticulated platelets ( RP ) are newly-formed platelets with a greater mass , a residual amount of RNA and an increased prothrombotic potential . No studies investigating the association between RP and the risk of cardiovascular death in acute coronary syndrome ( ACS ) patients are available . In the frame of the AMI-Florence 2 study , we investigated RP in 229 ( 154 M/ 75 F ) ACS patients ( 125 ST-elevation myocardial infa rct ion [ STEMI ] ; 104 Non-STEMI/Unstable Angina ) . RP were measured by using the Sysmex XE-2100 haematology analyzer and were expressed as the percentage of RP out of the total optical platelet count ( immature platelet fraction ; IPF ) and as the percentage of RP highly fluorescent ( H-IPF ) . At one-year follow-up , 22 out of 229 patients ( 9.6 % ) died from cardiovascular causes . Higher values of IPF ( p=0.05 ) and H-IPF ( p=0.006 ) were detected in dead compared to alive patients . A receiver operating characteristics curve analysis identified IPF ≥3.3 % and H-IPF ≥0.9 % as optimal cut-off values to predict cardiovascular death . At the multivariate model adjusted for the Global Registry of Acute Coronary Events ( GRACE ) risk score , the association between RP and cardiovascular death remained significant for both IPF [ OR ( 95%CI ) : 4.15 ( 1.24 - 13.91 ) p=0.02 ] and H-IPF [ OR ( 95%CI ) : H-IPF 5.03 ( 1.38 - 18.38 ) p=0.01 ] . In conclusion , RP are independent predictors of cardiovascular death and may be useful in improving risk stratification for ACS patients . Future prospect i ve studies to evaluate the role of RP in determining cardiovascular events are warranted Objectives . — Restenosis is the major limitation of coronary interventions occurring in nearly a third of the patients undergoing percutaneous transluminal coronary angioplasty ( PTCA ) with no single , definite predictor demonstrated in an individual patient . Platelets are known to play an important role in the pathogenesis of subsequent restenosis . Methods and results . — In a prospect i ve study , follow-up coronary angiographies were performed in 102 consecutive patients with stable angina who underwent a successful PTCA for single-vessel coronary artery disease . Demographics , baseline lipid profiles ( total cholesterol , HDL- and LDLcholesterol , triglycerides ) and haematological parameters ( red cell , white cell and platelet counts , haemoglobin concentration , haematocrite % , mean platelet volume , platelet mass and fibrinogen levels ) were compared between patients with and without restenosis . In the restenosis group , mean platelet volume ( 8.82 ± 0.78 fl vs. 8.13 ± 0.64 fl , p < 0.001 ) , white cell count ( 8673 ± 322 ≈ 103/μl vs. 7513 ± 232 ≈ 103/μl , p < 0.01 ) and fibrinogen level ( 4.2 ± 1.4 g/l vs 3.6 ± 1.1 g/l ) were significantly higher . The relative odds for developing angiographically defined restenosis were 2.49 times greater in diabetics ( p = 0.11 ) and 2.54 times greater in men ( p = 0.13 ) . It is 1.43 times greater in patients with higher fibrinogen levels ( p = 0.16 ) . But , the relative odds for developing restenosis were 10.43 times greater in patients with larger pre-procedural mean platelet volumes ( p < 0.01 ) . Conclusions . — There was a positive correlation between mean platelets volume and loss in luminal diameter between post-angioplasty and follow-up angiographies ( r = + 2.345 , p = 0.01 ) . There was no association between restenosis and haemoglobin , haematocrit , red cell count , white cell count , platelet count , platelet mass and plasma fibrinogen level . The development of restenosis after successful coronary angioplasty may be mainly influenced by the platelet size Abstract Both the Global Registry of Acute Coronary Events ( GRACE ) risk score and mean platelet volume ( MPV ) can independently predict adverse cardiovascular disease ( CVD ) events in patients with acute coronary syndrome ( ACS ) . This study was aim ed at investigating whether MPV was related to the GRACE risk score and whether the combination of them could have a better performance in predicting CVD in Patients with ACS . Totally 297 ACS patients were included . MPV was measured on admission . The GRACE risk score was calculated and its predictive value alone and together with MPV was assessed , respectively . During a median period of 52 months ( range , 6 to 65 ) , 11 of the 297 subjects ( 3.7 % ) were lost to follow-up , and 132 ( 46.2 % ) had adverse CVD including 32 deaths . Both MPV and the GRACE score were higher in patients with CVD events than those without events , and the GRACE score increased with the increase of MPV . Multivariate Cox analysis demonstrated that both MPV and the GRACE score were significant and independent predictors for CVD events ( HR : 1.13 ; 95 % CI : 1.10 to 1.15 ; p = 0.006 ; HR : 1.30 ; 95 % CI : 1.24 to 1.37 ; p < 0.001 ; respectively ) . The area under the ROC curve was 0.70 ( 95 % CI : 0.64 to 0.76 , p < 0.001 ) when the GRACE score was calculated alone , whereas it increased to 0.85 ( 95 % CI : 0.81 to 0.90 , p < 0.001 ) with the addition of MPV , indicating that the combination of MPV with the scoring system improved the predictive value . This study demonstrates for the first time that MPV is positively associated with the GRACE risk score and it may complement the scoring system in predicting CVD events in patients with ACS Platelet size has been shown to reflect platelet activity . We prospect ively measured the mean platelet volume ( MPV ) in 47 patients undergoing single vessel angioplasty for symptomatic angina . The patients underwent repeat angiography 4 - 8 months later irrespective of symptomatic status . Restenosis was assessed quantitatively by h and held calliper measurements of the lesion and qualitatively by a return of angina , ST segment changes on an exercise test and visual analysis of the lesion severity by two experienced angiographers . Twenty-four patients developed recurrent angina during the follow-up period , the MPV in the group with chest pain was 8.54 + /- 0.60 fl compared to 8.1 + /- 0.69 fl in the asymptomatic group ( P = 0.04 ) . Twenty two patients had significant ST segment changes at exercise . In this group the MPV was 8.6 + /- 0.56 fl compared to 8.0 + /- 0.70 fl for the group with a negative test ( P = 0.002 ) . Similarly visually assessed angiographic stenosis showed a significant increase in the restenotic group ( 8.6 + /- 0.56 vs. 8.0 + /- 0.61 fl , P = 0.001 ) . The relative odds for developing clinical ly defined restenosis were 10.2 times greater if the pre-procedural MPV lay in the upper compared to the lowest quartile . There was a positive correlation between MPV and change in minimal luminal diameter between post angioplasty and follow-up angiography , assessed quantitatively , r = + 0.56 , P = 0.016 . There was no association between clinical or angiographic definitions of restenosis and haemoglobin , red cell count , mean corpuscular volume , white cell count or platelet count . Platelet size may influence the development of restenosis after successful coronary angioplasty Abstract The aim of this study was to determine the associations of the mean platelet volume ( MPV ) high-sensitivity cardiac troponin T ( hs-cTnT ) and N-terminal pro-B type natriuretic peptide ( NT-proBNP ) with the development of adverse outcomes after percutaneous coronary intervention ( PCI ) . MPV hs-cTnT and NT-proBNP were analyzed in 372 patients who underwent PCI . The primary endpoint was cardiac death . The secondary endpoint analyzed was cardiovascular events ( CVE ) : the composite of cardiac death , myocardial infa rct ion ( MI ) , target vessel revascularization ( TVR ) , ischemic stroke and stent thrombosis ( ST ) . The median MPV hs-cTnT and NT-proBNP levels were 8.20 ( IQR 7.70–8.70 ) fL , 0.291 ( IQR 0.015–3.785 ) ng/mL , and 105.25 ( IQR 50.84–1128.5 ) pg/mL , respectively . There were 21 events of cardiac death , 10 MI ( including 4 events of ST ) , 7 ischemic strokes and 29 TVR during a mean of 25.8 months of follow-up . The Kaplan – Meier analysis revealed that the higher MPV group ( > 8.20 fL , median ) had a significantly higher cardiac death rate than the lower MPV group ( ≤8.20 fL ; 9.4 % vs. 2.1 % , log-rank : p = 0.0026 ) . When the MPV cut-off level was set to 8.20 fL using the receiver operating characteristic curve , the sensitivity was 81 % and the specificity was 53.3 % for differentiating between the group with cardiac death and the group without cardiac death . This value was more useful in patients with myocardial injury ( hs-cTnT ≥ 0.1 ng/mL ) or heart failure ( NT-proBNP ≥ 450 pg/mL ) . The results of this study show that MPV is a predictive marker for cardiac death after PCI ; its predictive power for cardiac death is more useful in patients with myocardial injury or heart failure Although platelet characteristics have an important influence on ischaemic heart disease , the nature of the association of platelet size and platelet count with death and reinfa rct ion after an index heart attack is unknown . Mean platelet volume ( MPV ) , a determinant of platelet reactivity , was measured in 1716 men six months after myocardial infa rct ion ( MI ) . Deaths and recurrent ischaemic heart disease events were then assessed at two years . MPV was greater in 126 men who had a further ischaemic event ( fatal or non-fatal ) than in the 1590 men who had no further MI ( p less than 0.001 ) . In addition , the MPV was larger in men who died than in those who did not ( p less than 0.001 ) . There was no difference in platelet count between these groups . When analysed by quartiles , consistent trends of increasing age-adjusted relative odds of death and recurrent ischaemic events were noted for MPV . MPV did not correlate with known ischaemic heart disease risk factors such as blood pressure , blood lipids , fibrinogen , white cell count , or plasma viscosity . We believe that MPV is a further independent risk factor for recurrent MI The aim of this study was to investigate the prognostic role of mean platelet volume ( MPV ) in patients with coronary artery ectasia ( CAE ) . The baseline MPV values of 258 patients with CAE were screened . The mean time of follow-up was 49 ± 21 months for major adverse cardiac events ( MACEs ) defined as the combination of cardiac death , nonfatal myocardial infa rct ion ( MI ) , rehospitalization due to cardiac disorders , and readmission due to chest pain . During follow-up period , 63 ( 24 % ) MACEs developed . There were 4 ( 2 % ) cardiovascular deaths , 0 nonfatal MI , 14 ( 5 % ) rehospitalization , and 45 ( 17 % ) readmission . Mean platelet volume values were significantly higher in patients with CAE with MACEs than in patients with CAE without MACEs ( 9.5 ± 1.2 fL vs 8.9 ± 1.1 fL , respectively , P = .002 ) . The rate of MACE was higher in CAE patients with MPV of > 9 fL than those with MVP of ≤9 fL ( 33 % vs. 15 % , P = .001 ) . Mean platelet volume has a prognostic value for MACEs in patients with CAE Platelets play a role in the pathogenesis of ST-segment elevation myocardial infa rct ion ( STEMI ) . We assessed the relationship between mean platelet volume ( MPV ) on admission and pre- and postinterventional flow with the infa rct -related artery ( IRA ) in patients with STEMI . We prospect ively included 840 patients with STEMI who underwent primary percutaneous coronary intervention ( PCI ) . The patients were divided into 3 groups according to MPV tertiles . Pre- and post-PCI Thrombolysis In Myocardial Infa rct ion ( TIMI ) flow grade was determined . Initial TIMI flow grade 3 was accepted as patent IRA . After the primary PCI , normal flow was defined as post-PCI TIMI flow 3 . When the MPV was increased , the incidence of pre-PCI patent IRA ( P = .004 ) and post-PCI normal TIMI flow ( P < .001 ) was significantly decreased . Multivariate analysis showed that MPV was independently associated with post-PCI TIMI flow grade BACKGROUND AND AIMS Patency of infa rct -related artery ( IRA ) before mechanical reperfusion with primary percutaneous coronary intervention ( PPCI ) has been associated with better prognosis in patients with ST-Elevation myocardial infa rct ion ( STEMI ) . Mean platelet volume ( MPV ) increases in STEMI patients and may be associated with increased thrombotic potential . In STEMI patients scheduled for PPCI we sought to assess whether mean platelet volume ( MPV ) , as measured at admission , correlates with " spontaneous " reperfusion of the IRA and short-term clinical outcome . METHODS Blood sample s were obtained on hospital admission in 617 consecutive patients ( 82 % men ; age 64 + or - 12 years ) with STEMI , before PPCI . 372 ( 61 % ) patients were treated with the GP IIb/IIIa blocker abciximab . The main study endpoint was mortality at 30 days . RESULTS MPV was significantly lower in patients with basal TIMI flow grade 2 -3 compared to patients with TIMI grade 0 - 1 ( median , 9 vs. 8.5 fL , p<0.0001 ) . After adjustment , MPV remained an independent predictor of the patency of the IRA ( OR 0.63 , CI 95 % 0.51 - 0.78 ) . A cut off value of 8.95 fL had a predictive negative value of 82 % to identify patients with patent IRA . Using this cut point , and after adjusting for confounders , MPV was an independent predictor of 30-day mortality ( HR 2.92 , CI 95 % 1.36 - 6.29 ) . When patients were subdivided according to abciximab use , MPV was a marker of worse outcome but only in patients who did not receive abciximab ( HR 3.67 , CI 95 % 1.13 - 11.49 ) . CONCLUSION An increased MPV is an independent predictor of both a patent IRA ( TIMI flow 2 or 3 before PPCI ) and 30-day mortality . This marker may be able to identify patients requiring more aggressive antiplatelet therapy BACKGROUND The mechanisms for the variability in antiplatelet effects of aspirin are unclear . Immature ( reticulated ) platelets may modulate the antiplatelet effects of aspirin through uninhibited cyclooxygenase (COX)-1 and COX-2 . OBJECTIVES To evaluate the role of reticulated platelets in the antiplatelet effects of aspirin . METHODS Sixty healthy volunteers had platelet studies performed before and 24 h after a single 325-mg dose of aspirin . Platelet studies included light transmission aggregometry ; P-selectin and integrin alpha(IIb)beta(3 ) expression , and serum thromboxane B(2 ) ( TxB(2 ) ) levels . Reticulated platelets and platelet COX-2 expression were measured using flow cytometry . RESULTS Subjects were divided into tertiles based on the percentage of reticulated platelets in whole blood . Baseline platelet aggregation to 1 microg mL(-1 ) collagen , and postaspirin aggregations to 5 microm and 20 microm ADP and collagen , were greater in the upper than in the lower tertile of reticulated platelets . Stimulated P-selectin and integrin alpha(IIb)beta(3 ) expression were also higher in the upper tertile both before and after aspirin . Platelet COX-2 expression was detected in 12 + /- 7 % ( n = 10 ) of platelets in the upper tertile , and in 7 + /- 3 % ( n = 12 ) of platelets in the lower two tertiles ( P = 0.03 ) . Postaspirin serum TxB(2 ) levels were higher in the upper ( 5.5 + /- 4 ng mL(-1 ) ) than in the lower tertile ( 3.2 + /- 2.5 ng mL(-1 ) , P = 0.03 ) , and decreased even further with ex vivo additional COX-1 and COX-2 inhibition . The incidence of aspirin resistance ( > or= 70 % platelet aggregation to 5 microm ADP ) was significantly higher in the upper tertile ( 45 % ) than in the lower tertile ( 5 % , P < 0.0001 ) . CONCLUSIONS Reticulated platelets are associated with diminished antiplatelet effects of aspirin and increased aspirin resistance , possibly because of increased reactivity , and uninhibited COX-1 and COX-2 activity 99mTc : technetium-99 m 201TI : thallium 201 ABCB1 : ATP-binding cassette sub-family B member 1 ABI : ankle-brachial index ACC : American College of Cardiology ACCF : American College of Cardiology Foundation ACCOMPLISH : Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension ACE : angiotensin converting enzyme ACIP : Asymptomatic Cardiac Ischaemia Pilot ACS : acute coronary syndrome ADA : American Diabetes Association ADP : adenosine diphosphate AHA : American Heart Association ARB : angiotensin II receptor antagonist ART : Arterial Revascularization Trial ASCOT : Anglo-Sc and inavian Cardiac Outcomes Trial ASSERT : Asymptomatic atrial fibrillation and Stroke Evaluation in pacemaker patients and the atrial fibrillation Reduction atrial pacing Trial AV : atrioventricular BARI 2D : Bypass Angioplasty Revascularization Investigation 2 Diabetes BEAUTIFUL : Morbidity-Mortality Evaluation of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Dysfunction BIMA : bilateral internal mammary artery BMI : body mass index BMS : bare metal stent BNP : B-type natriuretic peptide BP : blood pressure b.p.m . : beats per minute CABG : coronary artery bypass graft CAD : coronary artery disease CAPRIE : Clopidogrel vs. Aspirin in Patients at Risk of Ischaemic Events CASS : Coronary Artery Surgery Study CCB : calcium channel blocker CCS : Canadian Cardiovascular Society CFR : coronary flow reserve CHARISMA : Clopidogrel for High Atherothrombotic Risk and Ischaemic Stabilization , Management and Avoidance CI : confidence interval CKD : chronic kidney disease CKD-EPI : Chronic Kidney Disease Epidemiology Collaboration CMR : cardiac magnetic resonance CORONARY : The CABG Off or On Pump Revascularization Study COURAGE : Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation COX-1 : cyclooxygenase-1 COX-2 : cyclooxygenase-2 CPG : Committee for Practice Guidelines CT : computed tomography CTA : computed tomography angiography CV : cardiovascular CVD : cardiovascular disease CXR : chest X-ray CYP2C19 * 2 : cytochrome P450 2C19 CYP3A : cytochrome P3A CYP3A4 : cytochrome P450 3A4 CYP450 : cytochrome P450 DANAMI : Danish trial in Acute Myocardial Infa rct ion DAPT : dual antiplatelet therapy DBP : diastolic blood pressure DECOPI : Desobstruction Coronaire en Post-Infa rct us DES : drug-eluting stents DHP : dihydropyridine DSE : dobutamine stress echocardiography EACTS : European Association for Cardiothoracic Surgery EECP : enhanced external counterpulsation EMA : European Medicines Agency EASD : European Association for the Study of Diabetes ECG : electrocardiogram Echo : echocardiogram ED : erectile dysfunction EF : ejection fraction ESC : European Society of Cardiology EXCEL : Evaluation of XIENCE PRIME or XIENCE V vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization FAME : Fractional Flow Reserve vs. Angiography for Multivessel Evaluation FDA : Food & Drug Administration ( USA ) FFR : fractional flow reserve FREEDOM : Design of the Future Revascularization Evaluation in patients with Diabetes mellitus : Optimal management of Multivessel disease GFR : glomerular filtration rate HbA1c : glycated haemoglobin HDL : high density lipoprotein HDL-C : high density lipoprotein cholesterol HR : hazard ratio HRT : hormone replacement therapy hs-CRP : high-sensitivity C-reactive protein HU : Hounsfield units ICA : invasive coronary angiography IMA : internal mammary artery IONA : Impact Of Nicor and il in Angina ISCHEMIA : International Study of Comparative Health Effectiveness with Medical and Invasive Approaches IVUS : intravascular ultrasound JSAP : Japanese Stable Angina Pectoris KATP : ATP-sensitive potassium channels LAD : left anterior descending LBBB : left bundle branch block LIMA : Left internal mammary artery LDL : low density lipoprotein LDL-C : low density lipoprotein cholesterol LM : left main LMS : left main stem LV : left ventricular LVEF : left ventricular ejection fraction LVH : left ventricular hypertrophy MACE : major adverse cardiac events MASS : Medical , Angioplasty , or Surgery Study MDRD : Modification of Diet in Renal Disease MERLIN : Metabolic Efficiency with Ranolazine for Less Ischaemia in Non-ST-Elevation Acute Coronary Syndromes MERLIN-TIMI 36 : Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes : Thrombolysis In Myocardial Infa rct ion MET : metabolic equivalents MI : myocardial infa rct ion MICRO-HOPE : Microalbuminuria , cardiovascular and renal sub- study of the Heart Outcomes Prevention Evaluation study MPI : myocardial perfusion imaging MRI : magnetic resonance imaging NO : nitric oxide NSAIDs : non-steroidal anti-inflammatory drugs NSTE-ACS : non-ST-elevation acute coronary syndrome NYHA : New York Heart Association OAT : Occluded Artery Trial OCT : optical coherence tomography OMT : optimal medical therapy PAR-1 : protease activated receptor type 1 PCI : percutaneous coronary intervention PDE5 : phosphodiesterase type 5 PES : paclitaxel-eluting stents PET : positron emission tomography PRECOMBAT : Premier of R and omized Comparison of Bypass Surgery vs. Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease PTP : pre-test probability PUFA : polyunsaturated fatty acid PVD : peripheral vascular disease QoL : quality of life RBBB : right bundle branch block REACH : Reduction of Atherothrombosis for Continued Health RITA-2 : Second R and omized Intervention Treatment of Angina ROOBY : Veterans Affairs R and omized On/Off Bypass SAPT : single antiplatelet therapy SBP : systolic blood pressure SCAD : stable coronary artery disease SCORE : Systematic Coronary Risk Evaluation SCS : spinal cord stimulation SES : sirolimus-eluting stents SIMA : single internal mammary artery SPECT : single photon emission computed tomography STICH : Surgical Treatment for Ischaemic Heart Failure SWISSI II : Swiss Interventional Study on Silent Ischaemia Type II SYNTAX : SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery TC : total cholesterol TENS : transcutaneous electrical neural stimulation TERISA : Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina TIME : Trial of Invasive vs. Medical therapy TIMI : Thrombolysis In Myocardial Infa rct ion TMR : transmyocardial laser revascularization TOAT : The Open Artery Trial WOEST : What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing Guidelines summarize and evaluate all evidence available , at the time of the writing process , on a particular issue with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition , taking into account the impact on outcome , as well |
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