title: Ten-year incidence and natural history of gallstone disease in a rural population of women in central Italy. The Rome Group for the Epidemiology and Prevention of Cholelithiasis (GREPCO). The Effect of a Multimedia Health Educational Program on the Postoperative Recovery of Patients undergoing Laparoscopic Cholecystectomy Literature searching for randomized controlled trials used in Cochrane reviews: rapid versus exhaustive searches. Prevalence of gallstones in a Danish population. Longitudinal study of gall stone prevalence at necropsy. Nurses and occupational violence: the role of organisational support in moderating professional competence. The effect of pre-admission education on domiciliary recovery following laparoscopic cholecystectomy. Extended preoperative patient education using a multimedia DVD—impact on patients receiving a laparoscopic cholecystectomy: a randomised controlled trial Methods for combining randomized clinical trials: strengths and limitations. A brief relaxation intervention reduces stress and improves surgical wound healing response: A randomised trial Enhancement of Surgical Informed Consent by Addition of Repeat Back: A Multicenter, Randomized Controlled Clinical Trial The quality of cholecystectomy in Denmark: outcome and risk factors for 20,307 patients from the national database Predictors of comprehension during surgical informed consent. The informed consent: a study of the efficacy of informed consents and the associated role of language barriers. Use of a preanesthetic video for facilitation of parental education and anxiolysis before pediatric ambulatory surgery. The effect of interactive multimedia on preoperative knowledge and postoperative recovery of patients undergoing laparoscopic cholecystectomy. Improving Informed Consent of Surgical Patients Using a Multimedia-Based Program?: Results of a Prospective Randomized Multicenter Study of Patients Before Cholecystectomy Influence of Reported Study Design Characteristics on Intervention Effect Estimates From Randomized, Controlled Trials
abstract: AIMS To investigate the incidence , risk factors and natural history of gallstone disease , a r and om sample of females belonging to a rural population was enrolled in a ten-year longitudinal study . METHODS The study has been performed in a small town on the hills south of Rome . In 1985 , a r and om sample of 426 females , aged 20 - 69 years , was screened by real-time ultrasonography for gallstones and previous cholecystectomy .  Screening methods included anthropometry , collection of a blood sample and a question naire on the occurrence of abdominal symptoms . During 1995 , all these subjects were invited for a 10-year follow-up examination . RESULTS The overall 10-year incidence of gallstone disease was 6.3 % ( 5.5 % of new gallstones and 0.8 % of cholecystectomies ) . Only 23.1 % of the women with gallstones were aware of their condition . More than three quarters ( 76.9 % ) had not suffered biliary pain . Univariate and multivariate analyses demonstrated a positive independent association of new gallstone disease with body mass index and parity . Out of the initially asymptomatic gallstone women , 15.4 % experienced at least one episode of biliary pain , 23.1 % were su bmi tted to elective cholecystectomy and 61.5 % remained asymptomatic . CONCLUSIONS The study demonstrates a high incidence of gallstone disease in women belonging to a rural free-living population in Italy and suggests body mass index and parity as possible true risk factors . Moreover , it confirms that a remarkable proportion of asymptomatic patients become symptomatic and eventually undergo cholecystectomy Aim of this study is the evaluation of the impact of preoperative informative session using a Multimedia Health Educational Program ( MHEP ) on patients undergoing elective Laparoscopic Cholecystectomy ( LC ) for cholelithiasis , preoperative anxiety and postoperative pain and nausea . Sixty consecutive patients scheduled for elective LC were considered for enrollment in the trial . Patients were assigned r and omly to four groups : Group A included 15 patients , preoperatively informed regarding LC through the MHEP presented by a Registered Nurse ( RN ) . Group B included 15 patients  preoperatively informed through a leaflet ( design ed and developed using the exact contents of the MHEP ) . In Group C , there were 15 patients who were being informed verbally from the RN . Finally , the control Group D included 15 patients , who had the conventional preoperative information about the operation and postoperative course by the attending surgeon and anesthesiologist , as every other patient included in groups A , B , C. Preoperative assessment of patient 's knowledge about cholelithiasis and LC was performed after informative session , and was based on a specifically developed " closed , true-false " question naire . Preliminary results suggest that conventional information provided by the attending surgeon ( Group D ) is inadequate . Specifically developed informative sessions with the contribution of MHEP seems to be effective on reducing preoperative anxiety and postoperative pain , in patients undergoing elective LC OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials A r and om sample of 4,807 men and women , aged 30 , 40 , 50 , and 60 years , who lived in the western part of Copenhagen County , was drawn from the National Central Person Registry . A total of 226 subjects who were not of Danish origin were omitted . The response rate was 78.8 % ( 3,608/4,581 ) . Each person had his or her gallbladder examined by ultrasonography . The examinations took place between November 1982 and February 1984 . The overall prevalence of gallstone disease ( cases with stones and cholecystectomized cases ) in males aged 30 , 40 , 50 , and 60 years was 1.8 % , 1.5 % , 6.7 % , and 12.9 % , respectively . The corresponding prevalence in females was 4.8 % , 6.1 % , 14.4 % , and 22.4 % , respectively . Differences according to sex were significant in all age groups . Differences between the 40- and 50-year and 50- and 60-year age groups were significant in both sexes . Among subjects with gallstone disease , the disease was unknown to the prob and in the majority of males and in the 30-year-old females , but only in half of the women aged 40 , 50 , and 60 years . The prevalence of clinical ly diagnosed gallstones was not significantly different between respondents and nonrespondents A prospect i ve study of the prevalence of gall stone disease at necropsy in a stable population has been undertaken over a 10 year period up to June 1988 . In women , the prevalence of gall stone disease remained static but in men aged 50 - 59 years it rose from 7 % ( n = 148 ) in the first three years to 18 % ( n = 138 ) in the last three years ( p less than 0.01 ) and in men aged 60 - 69 it rose from 12 % ( n = 370 ) to 20 % ( n = 366 , p less than 0.01 ) . In the latter age group the female : male ratio fell from 2:1 to 0.8:1 . The proportion of deaths from coronary heart disease in men fell slightly in those over 70 during the study period . There was a fall in deaths from coronary heart disease in all age groups in women . Men with gall stones were less likely to have had a  cholecystectomy  than women , and overall 88 % of gall stones remained in situ . In a parallel clinical study , the number of cholecystectomies  carried out in the same district fell by 18 % over the 10 years without any apparent change in the provision of re sources .  Cholecystectomy  remained almost three times more frequent in women . National data indicate that there have been major changes in the average diet before and during the period of study in favour of reducing coronary heart disease . There has been no change in mortality from coronary heart disease in young men but if the observed increase in the prevalence of gall stones in men and the decrease in deaths from coronary heart disease in women are real phenomena , it seems likely that they are diet related OBJECTIVE Occupational violence as experienced by professional nurses has been extensively research ed . However , the majority of studies have focused primarily on psychological and emotional outcomes and have not identified any interventions that may reduce the impact of aggressive behaviour on professional competence . The purpose of this study was to investigate the relationship between organisational support , occupational violence and perceived professional competence of professional nurses in Australia . DESIGN A model testing research design was used to test the hypothesis that organisational support , as experienced by nurses , would moderate the relationship between occupational violence and perceived professional competence . SETTING Nurses registered in Division 1 of the Nurses Board ( Victoria , Australia ) . PARTICIPANTS A systematic r and om sample of 380 registered nurses from the target population of nurses in Victoria was identified . MAIN OUTCOME MEASURE The relationship between organisational support , occupational violence and perceived professional competence of professional nurses in Australia . RESULTS The result showed that there was a significant effect of occupational violence on perceived competence . Analysis of the moderating effect of organisational support on the relationship between occupational violence and professional competence showed there was significant  organisational support  and  occupational violence  interaction . Overall , the data analysis demonstrated the hypothesis was upheld that the negative effects of occupational violence on perceived professional competence will be moderated by perceived organisational support . CONCLUSIONS The failure to receive appropriate organisational support may result in lowering  professional nurses ' competence levels , causing a significant problem for the profession in that a reduction in professional competence has significant implication s for patient care . The findings heighten the responsibility of the nursing profession to become more aware of the needs of professional nurses OBJECTIVES The objectives of this r and omised controlled study were to determine if pre-admission patient education affects post-operative pain levels , domiciliary self-care capacity and patient recall following a laparoscopic cholecystectomy ( LC ) . Participants were r and omised to receive the st and ard preadmission program ( SP ) or an individualised , education intervention ( El ) . DESIGN A pre-operative question naire was administered in the pre-admission clinic to determine participants ' knowledge of LC and post-operative management . Telephone follow-up and post-operative question naire were conducted approximately 14 days post discharge . SETTING Preadmission clinic of a Sydney , Australia , tertiary referral hospital . SAMPLE Ninety-three elective LC patients . RESULTS EI participants experienced lower pain levels and had significantly greater recall of provided information . However , no significant differences were found between the control and intervention groups for domiciliary self-care . CONCLUSION Pre-admission education intervention helps reduce post-operative pain levels following LC and significantly increases patients ' knowledge of self-care and complication management Purpose The informed consent is a legal requirement prior to surgery and should be based on an extensive preoperative interview . Multimedia productions can therefore be utilised as supporting tool . In a prospect i ve r and omised trial , we evaluated the impact of an extended education on patients undergoing cholecystectomy . Material s and methods For extended patient information , a professionally built DVD was used . After r and omisation to either the DVD or the control group , patients were informed with or without additional presentation of the DVD . The quality of education was evaluated using a purpose -built question naire . Results One hundred fourteen patients were included in the DVD and 98 in the control group .  Patient characteristics did not differ significantly despite a higher educational level in the DVD group . The score of correctly answered questions was higher in the DVD group ( 19.88 vs. 17.58 points , p < 0.001 ) . As subgroup analysis revealed , particular patient characteristics additionally impacted on results . Conclusion Patients should be informed the most extensively prior to any surgical procedure . Multimedia productions therefore offer a suitable instrument . In the presented study , we could prove the positive impact of an information DVD on patients knowledge . Nevertheless , multimedia tools can not replace personal interaction and should only be used to support daily work Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . Psychological stress has been shown to impair wound healing , but experimental research in surgical patients is lacking . This study investigated whether a brief psychological intervention could reduce stress and improve wound healing in surgical patients . This r and omised controlled trial was conducted at a surgical centre . Inclusion criteria were English-speaking patients over 18 years booked to undergo elective laparoscopic cholecystectomy ; exclusion criteria were cancellation of surgery , medical complications , and refusal of consent . Seventy five patients were r and omised and 15 patients were excluded ; 60 patients completed the study ( 15 male , 45 female ) . Participants were r and omised to receive st and ard care or st and ard care plus a 45-min psychological intervention that included relaxation and guided imagery with take-home relaxation CDs for listening to for 3 days before and 7 days after surgery . In both groups ePTFE tubes were inserted during surgery and removed at 7 days after surgery and analysed for hydroxyproline as a measure of collagen deposition and wound healing . Change in perceived stress from before surgery to 7-day follow-up was assessed using question naires . Intervention group patients showed a reduction in perceived stress compared with the control group , controlling for age . Patients in the intervention group had higher hydroxyproline deposition in the wound than did control group patients ( difference in means 0.35 , 95 % CI 0.66 - 0.03 ; t(43)=2.23 , p=0.03 ) . Changes in perceived stress were not associated with hydroxyproline deposition . A brief relaxation intervention prior to surgery can reduce stress and improve the wound healing response in surgical patients . The intervention may have particular clinical application for those at risk of poor healing following surgery Objective : In this r and omized , controlled , unblinded trial , we sought to test Repeat Back 's ( RB ) effect on comprehension following informed consent discussion s. Summary Background Data : RB has been suggested as a method to improve patient comprehension when obtaining informed consent . In this technique , patients are asked to recount what they have been told in the informed consent discussion . Despite preliminary data , this practice has not been evaluated in any large scale study . Methods : This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent , the VA 's computer based platform . Patients scheduled for elective surgeries were r and omized to RB ( a module added to the iMedConsent package ) or st and ard iMedConsent ( no RB ) .  Comprehension was tested after the informed consent using procedure-specific question naires . Time stamps in the iMedConsent program estimated the time spent completing the informed consent process . Provider and patient satisfaction were measured using 5-point Likert scales . Statistical comparisons of groups were performed using t-tests and & khgr;2 tests . Results : A total of 575 patients were enrolled . In the RB group , providers spent 2.6 minutes longer ( P < 0.0001 ) obtaining informed consent . The mean comprehension score was significantly higher in the RB group ( 71.4 % ) versus the no RB group ( 68.2 % , P = 0.03 ) ; the effect was greatest in carotid endarterectomy patients ( RB = 73.4 % vs. no RB = 67.7 % , P = 0.02 ) . Quality of decision making was rated similarly . Providers were neutral to slightly favorable regarding RB . Conclusions : RB implemented within an electronic informed consent system improved patient comprehension . The additional time required was acceptable to providers . RB should be considered as an enhancement to surgical informed consent . This clinical trial was registered at http://www . clinical trials.gov ( Identifier NCT00288899 ) Background Laparoscopic cholecystectomy is the st and ard treatment for symptomatic gallstones . The quality of the procedure frequently is included in quality improvement programs , but outcome values have not been described to define the st and ard of care for a general population . This study included 20,307 cholecystectomies from a national prospect i ve data base that combines administrative data with clinical data . This report states the quality of  cholecystectomy  in Denmark , establishes benchmarks , and identifies significant risk factors . Methods The Danish Cholecystectomy Data base was queried for data from 2006 to 2009 . The outcome measures included conversion rate , hospital length of stay ( LOS ) , readmission , additional procedures , and 30-day mortality . Patient characteristics and operative findings were analyzed as risk factors using stepwise backward logistic regression . Results The study included 20,307 patients ( 82 % of all cholecystectomies ) . The conversion rate was 7.6 % . Male sex , acute cholecystitis , and previous upper abdominal surgery were risk factors for conversion , with respective odds ratios of 1.50 , 4.61 , and 3.54 . The mean LOS was 1.5 days , and 37.3 % of the patients had same-day surgery . The readmission rate was 9.6 % . Nearly 70 % had a LOS of 1 day or less and no readmission ; 17.3 % had a LOS longer than 3 days and /or readmission ; 5.6 % had an additional procedure within 30 days ; and 0.2 % had a bile duct injury requiring reconstructive surgery . The 30-day mortality rate was 0.27 % . Age older than 60 years , American Society of Anesthesiology ( ASA ) score exceeding 1 , and open procedure were significant risk factors for all the outcomes . Body mass index ( BMI ) was not a risk factor for any of the outcomes . Conclusion The quality of cholecystectomy is high in Denmark , with a low conversion rate and a high frequency of short admissions without readmission . Acute cholecystitis and open procedure are important risk factors for poorer outcomes .The results of this study analyzing a large , unbiased population can be used to benchmark outcomes of cholecystectomy BACKGROUND Patient comprehension during surgical informed consent  remains problematic . Using data from our r and omized trial of methods to improve informed consent comprehension , we performed an additional analysis to define independent factors associated with improved patient underst and ing . STUDY DESIGN Patients scheduled for 1 of 4 elective operations ( total hip arthroplasty [ n = 137 ] , carotid endarterectomy [ n = 178 ] , laparoscopic cholecystectomy [ n = 179 ] , or radical prostatectomy [ n = 81 ] ) at 7 Department of Veterans Affairs ( VA ) medical centers were enrolled . All informed consent discussion s were performed using iMedConsent ( Dialog Medical ) , the VA 's computerized informed consent platform . Using a unique module within iMedConsent , we r and omized patients to repeat back ( RB ) , requiring correct reiteration of procedure-specific facts , or st and ard ( STD ) iMedConsent . Patient comprehension was tested after the informed consent discussion using procedure-specific question naires . Time spent completing the informed consent process was measured using time stamps within iMedConsent . Multiple linear regression identified factors independently associated with improved comprehension . RESULTS We enrolled 575 patients ( 276 RB , 299 st and ard ) ; 93 % were male , 74 % were Caucasian , and 89 % had at least a high school education . Independent factors associated with improved comprehension included race ( p < 0.01 ) , ethnicity ( p < 0.05 ) , age ( p < 0.02 ) , operation type ( p < 0.01 ) , group assignment ( + /- RB ; p < 0.05 ) , and total consent time ( p < 0.0001 ) . Patient comprehension was maximized when informed consent took between 15 and 30 minutes . RB 's positive impact on patient comprehension was weaker in the analysis including consent time . CONCLUSIONS Comprehension during informed consent discussion s may be limited in individuals with potential language difficulty due to ethnicity or education . Total consent time was the strongest predictor of patient comprehension . Affording adequate time for informed consent discussion s and using informed consent adjuncts such as RB may enhance comprehension in such individuals BACKGROUND Obtaining informed consent before performing invasive procedures and operations has become a st and ard practice at all medical institutions in the United States . All agree that patients should be both conscious of and in agreement with their medical care . Though patients routinely sign consent forms with numerous risks and complications detailed , there are only a limited amount of reports that study if these patients have a thorough underst and ing of those risks and complications . Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English . To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy  understood the complications associated with this procedure . METHODS We conducted a r and omized prospect i ve study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy . Fifty patients agreed to participate in our study . Participants were split into two groups . In the first group ( the control group ) surgical benefits , risks and complications were explained in the usual fashion . In the second group , after hearing the st and ard explanation of surgical risks , complications and benefits , patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy . Patients from both groups then took a ten question assessment based on the presentations that they encountered . Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment . The patients ' age , education level , income , and birth country were also studied . RESULTS Fifty-two percent of the patients in the study were born outside of the United States . All of the non-US born patients were Hispanic and their primary language was Spanish . The average age of the studied patients was 38 . Sixty-eight percent of the patients reported an education level no higher than high school . The majority of the studied patients noted an  income of less than $ 40,000 . Differences were seen between patient native to the US and those born outside the United States . US born patients had an 80 % correct response rate versus non-US born patients who had only a 63 % correct response . Differences were seen between US born patient and non-US born patients concerning the topics of the severity of a common bile duct injury , gastrointestinal changes after cholecystectomy and the safety concerning conversion from laparoscopic to open cholecystectomy . No difference was appreciated in the PowerPoint group versus the non-PowerPoint group . CONCLUSION The addition of a PowerPoint presentation did not increase underst and ing of the risks and benefits associated with a laparoscopic cholecystectomy . This study did however highlight the problem of obtaining consent from foreign born patients . Patients who were not US natives showed a decreased underst and ing of the surgical procedure and the severity of the complications in both the control group and the PowerPoint group . Better methods of educating foreign patients should be investigated to truly obtain informed consents from this patient population UNLABELLED In this study , we evaluated the effects of viewing an educational videotape about pediatric anesthesia on measures of parental knowledge of anesthesia and preoperative anxiety using a r and omized , controlled design . During their routine preoperative visit , 85 parents of children scheduled to undergo ambulatory surgical procedures under general anesthesia were r and omized to view either the experimental videotape about pediatric anesthesia or a control videotape with no medical content . Before and immediately after viewing the assigned videotape , parents completed measures of situational anxiety ( State-Trait Anxiety Inventory-State ) , preoperative anxiety and need for information ( Amsterdam Preoperative Anxiety and Information Scale ) , and anesthesia knowledge ( St and ard Anesthesia Learning Test ) . Repeated- measures analyses of variance showed that parents who viewed the experimental videotape showed a significant increase in anesthesia knowledge ( P < 0.022 ) and a significant reduction in their state of anxiety ( P < 0.031 ) , anesthesia-specific anxiety , and need for information ( P < 0.0001 ) compared with the control group . These results demonstrated that viewing a preoperative educational videotape about pediatric anesthesia can provide immediate educational and anxiolytic benefits for parents of children undergoing ambulatory surgery . The duration of these benefits remains to be determined . IMPLICATION S In this study , we demonstrated the benefits of viewing an educational videotape about pediatric anesthesia on measures of parental knowledge of anesthesia and preoperative anxiety using a r and omized , controlled design . We found that videotape viewing facilitated preoperative preparation and lessened preoperative anxiety OBJECTIVES Aim of this study is the evaluation of the impact of a multimedia CD ( MCD ) on preoperative anxiety and postoperative recovery of patients undergoing elective laparoscopic cholecystectomy ( LC ) . METHODS Sixty consecutive c and i date s for elective LC were r and omly assigned to four groups . Group A included 15 patients preoperatively informed regarding LC through the MCD presented by Registered Nurse ( RN ) . Patients in group B ( n = 15 ) were informed through a leaflet . Patients in group C ( n = 15 ) were informed verbally from a RN . Finally , the control Group D included 15 patients  informed conventionally by the attending surgeon and anesthesiologist , as every other patient included in groups A , B , and C. Preoperative assessment of knowledge about LC was performed after each informative session through a question naire . Evaluation of preoperative anxiety was conducted using APAIS scale . Postoperative pain and nausea scores were measured using an NRS scale , 16 hours after the patient had returned to the ward . RESULTS Statistical processing of the results ( single linear regression ) showed that patients in groups A , B , and C achieved a higher knowledge score , less preoperative anxiety score and less postoperative pain and nausea , compared to Group D. In multiple regression analysis , group A had a higher knowledge score compared to the four groups ( p < 0.001 r(2 ) = 0.41 ) . CONCLUSION Informative sessions using MCD is an effective means of improving patient 's preoperative knowledge , especially in day-surgery cases , like LC Objective : The term “ informed consent ” explains the process by which a patient , before treatment , is provided comprehensive and impartial information regarding a planned operative procedure so that he/she underst and s the implication s of the procedure before consenting . The goal of the current study was to investigate whether st and ard methods of consenting can be improved using a multimedia-based information program ( MM-IP ) . Patients and Methods : In a prospect i ve multicenter study , 80 patients undergoing laparoscopic cholecystectomy went through the st and ard informed consent process . One group of patients was also given access to a MM-IP . Question naires were completed before surgery . These evaluated how patients perceived their own underst and ing of important aspects of their illness ( ie , disease , therapeutic alternatives , operation , risks ) and satisfaction with the consenting process . Patients ’ anxiety levels were also assessed . These question naires were used to evaluate the effectiveness of the MM-IP for improving the consent process . Results : Seventy-six patients ( 47 women , 29 men , median age 54 years ) were included . There was no significant age or gender variation between the groups ( st and ard n = 41 and MM-IP n = 35 ) . Eighty-two percent of all respondents were satisfied with the st and ard informed consent process . However , perceived underst and ing of the material was significantly improved in the MM-IP group ( P < 0.001 ) . Patients with less formal education profited particularly from the MM-IP .  Preoperative anxiety did not vary between the groups . Conclusion : Use of the multimedia-based program was positively evaluated by patients , and significantly improved patients ’ perceived underst and ing of their disease and its treatment . It is , therefore , valuable in the informed consent process Published evidence suggests that aspects of trial design lead to biased intervention effect estimates , but findings from different studies are inconsistent . This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials . Outcome measures were classified as " mortality , " " other objective , " " or subjective , " and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity . Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear ( vs. adequate ) r and om-sequence generation ( ratio of odds ratios , 0.89 [ 95 % credible interval { CrI } , 0.82 to 0.96 ] ) and with inadequate or unclear ( vs. adequate ) allocation concealment ( ratio of odds ratios , 0.93 [ CrI , 0.87 to 0.99 ] ) . Lack of or unclear double-blinding ( vs. double-blinding ) was associated with an average of 13 % exaggeration of intervention effects ( ratio of odds ratios , 0.87 [ CrI , 0.79 to 0.96 ] ) , and between-trial heterogeneity was increased for such studies ( SD increase in heterogeneity , 0.14 [ CrI , 0.02 to 0.30 ] ) . For each characteristic , average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes , with little evidence of bias in trials with objective and mortality outcomes . This study is limited by incomplete trial reporting , and findings may be confounded by other study design characteristics . Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes
target: Due to the very low quality of the current evidence , the effects of formal patient education provided in addition to the st and ard information provided by doctors to patients compared with st and ard care remain uncertain .
background: BACKGROUND Generally , before being operated on , patients will be given informal information by the healthcare providers involved in the care of the patients ( doctors , nurses , ward clerks , or healthcare assistants ) .
  This information can also be provided formally in different formats including written information , formal lectures , or audio-visual recorded information .
  OBJECTIVES To compare the benefits and harms of formal preoperative patient education for patients undergoing laparoscopic cholecystectomy .