title: How long should outpatient pulmonary rehabilitation be? A randomised controlled trial of 4 weeks versus 7 weeks Long-term oxygen therapy improves health-related quality of life. Measurement of short-term changes in dyspnea and disease-specific quality of life following an acute COPD exacerbation. Self- and Proxy-Report Agreement on the Stroke Impact Scale The COPD assessment test (CAT): response to pulmonary rehabilitation. A multicentre, prospective study Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD): study protocol for a randomised controlled trial Marital adjustment among patients with chronic obstructive pulmonary disease who are participating in pulmonary rehabilitation. Effect of rollator use on health-related quality of life in individuals with COPD. Outcome evaluation of a randomized trial of the PhoenixCare intervention: program of case management and coordinated care for the seriously chronically ill. The Veterans Short Form 36 questionnaire is predictive of mortality and health-care utilization in a population of veterans with a self-reported diagnosis of asthma or COPD. Effect of tiotropium on health-related quality of life as a primary efficacy endpoint in COPD A randomized controlled trial to evaluate the effect of informing patients about their pretreatment responses to two respiratory questionnaires. Development and first validation of the COPD Assessment Test Feasibility of retinoids for the treatment of emphysema study. [Can individualized rehabilitation improve functional independence in elderly patients with COPD?]. Power of outcome measurements to detect clinically significant changes in pulmonary rehabilitation of patients with COPD. Development of the EXACT-U: a preference-based measure to report COPD exacerbation utilities. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Feasibility of distractive auditory stimuli on upper extremity training in persons with chronic obstructive pulmonary disease. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD Quality of life in elderly patients with COPD: measurement and predictive factors. Measuring functional status in chronic lung disease: conclusions from a randomized control trial. A randomized clinical trial of lung volume reduction surgery versus best medical care for patients with advanced emphysema: a two-year study from Canada. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. The Effects of Pulmonary Rehabilitation in the National Emphysema Treatment Trial. Induced sputum and other outcome measures in chronic obstructive pulmonary disease: safety and repeatability. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. The short-form chronic respiratory disease questionnaire was a valid, reliable, and responsive quality-of-life instrument in acute exacerbations of chronic obstructive pulmonary disease. Evaluation of the minimal important difference for the feeling thermometer and the St. George's Respiratory Questionnaire in patients with chronic airflow obstruction. A measure of quality of life for clinical trials in chronic lung disease. Physiologic Variables and Functional Status Independently Predict COPD Hospitalizations and Emergency Department Visits in Patients with Severe COPD Impact of brief or extended exercise training on the benefit of a dyspnea self-management program in COPD. Quality of life changes in COPD patients treated with salmeterol. Acute exacerbations of COPD in subjects completing pulmonary rehabilitation. The talking touchscreen: a new approach to outcomes assessment in low literacy. A randomized trial of two types of nurse-assisted home care for patients with COPD. Validity of the SF-12 Compared with the SF-36 Health Survey in Pilot Studies of the Australian Longitudinal Study on Women's Health
abstract: Background : The evidence of benefit for pulmonary rehabilitation ( PR ) programmes is established . However , the optimal duration of a PR programme is not known . A r and omised controlled trial was undertaken in patients with chronic obstructive pulmonary disease ( COPD ) to assess whether a 4 week PR programme was equivalent to our conventional 7 week PR programme at equivalent time points of 7 weeks and 6 months . Methods : One hundred patients ( 56 men ) with stable COPD of mean ( SD ) age 70 ( 8) years and forced expiratory volume in 1 second ( FEV1 ) 1.13 ( 0.50 ) litres were r and omised to either a 7 week ( n = 50 ) or 4 week ( n = 50 ) supervised PR programme . Patients were assessed at baseline , at completion of the supervised PR programme , and 6 months later . Patients r and omised to the 4 week group were also assessed at the 7 week time point . Outcome measures were the Incremental Shuttle Walk Test , Endurance Shuttle Walk Test ( ESWT ) , Chronic Respiratory Question naire-Self Reported , and the Breathing Problems Question naire . Results : Forty one patients in each group completed the PR programme . Patients made significant within group improvements after supervised rehabilitation . There were no statistically significant differences between the groups for any other measure at the 7 week or 6 month time points , except that patients in the 4 week group attained higher ESWT times ( mean difference 124 seconds ( 95 % CI 17.00 to 232.16 ) , p = 0.024 ) at the 7 week time point . Conclusions : A shortened 4 week supervised PR programme is equivalent to a 7 week supervised PR programme at the comparable time points of 7 weeks and 6 months Guidelines for the prescription of long-term oxygen therapy ( LTOT ) in hypoxemic COPD patients are based on two l and mark studies in which survival was the primary outcome . Such patients are importantly symptomatic with poor health-related quality of life ( HRQL ) but the effect of LTOT on HRQL remains uncertain . We undertook a prospect i ve longitudinal interventional study of consecutive COPD patients referred to our regional oxygen service ; n = 43 fulfilling criteria and commenced on LTOT , n = 25 not fulfilling criteria and continued on st and ard care .  HRQL was measured at baseline , 2 and 6 months . Both patient groups had severe COPD as defined by mean FEV1 < 35 % predicted . At baseline the LTOT group demonstrated significantly worse HRQL as defined by the Chronic Respiratory Question naire ( CRQ ) ( fatigue , emotional function , mastery and total scores ) , total generic Dartmouth COOP Charts and anxiety domain of the Hospital Anxiety and Depression scale . Significant improvements in HRQL were noted at 2 and 6 months in the LTOT group . Conversely the non-LTOT group demonstrated a progressive decline in HRQL . Using vali date d criteria for a minimal clinical ly significant improvement in CRQ , there were 28 ( 67 % ) and 26 ( 68 % ) ' responders ' at 2 and 6 months respectively in the LTOT group . The introduction of LTOT to patients with severe COPD fulfilling st and ard criteria was associated with early significant improvements in HRQL with sustained or further response at 6 months STUDY OBJECTIVE To determine whether currently available measurement tools can be used to obtain valid measurements of short-term changes in dyspnea and disease-specific quality of life ( QOL ) in out patients with an acute COPD exacerbation . DESIGN Prospect i ve cohort study . METHODS Sixty-six patients with an acute COPD exacerbation who presented to the emergency department completed the chronic respiratory disease index question naire ( CRQ ) and the baseline dyspnea index ( BDI ) and were discharged home receiving 10 days of medical therapy .  Re assessment with the  CRQ and the transitional dyspnea index ( TDI ) occurred within 48 h of relapse ( defined as an urgent hospital revisit within 10 days because of worsening respiratory symptoms ) , or 10 days later if relapse did not occur . RESULTS Patients who did not relapse ( n = 49 ) showed moderate-to-large improvements in disease-specific QOL across all four CRQ domains ( improvements in each domain of 1.4 to 1.9 U ; p < 0.001 for all domains ) and large positive changes in the TDI ( total TDI score , + 5.02 plus minus 0.55 U ; p = 0.0001 ) . In contrast , patients who had a relapse ( n = 17 ) did not have improved CRQ or TDI scores ( mean negative change in three of four CRQ domains , total TDI score - 3.06 plus minus 1.14 U ; p = 0.02 ) . Changes in the CRQ dyspnea score and TDI correlated with each other ( r = 0.78 ; p = 0.0001 ) and with changes in FEV(1 ) ( CRQ , r = 0.48 and p = 0.0001 ; TDI , r = 0.46 and p = 0.0002 ) . Ten control patients with stable COPD showed no changes in the CRQ or TDI over 10 days . CONCLUSION The CRQ and BDI/TDI can be used to obtain valid , responsive measures of acute changes in QOL and dyspnea associated with a COPD exacerbation . The direction and magnitude of change in these scores was highly correlated with clinical outcome and with other health measures . Most out patients treated for a COPD exacerbation experience significant short-term improvements in QOL and dyspnea , with the exception of patients who have a clinical relapse of symptoms Background and Purpose — The purpose of this study was to examine proxy – patient agreement on the domains of the Stroke Impact Scale ( SIS ) , as per the proxy – proxy perspective . Methods — Stroke patients were prospect ively assessed by means of the NIH Stroke Scale , Barthel index , and modified Rankin scale . Proxies and patients answered the Hospital Anxiety and Depression Scale and the SIS 3.0 . Comparisons of patient – proxy mean scores ( paired t test ) , effect size , and intraclass correlation coefficients ( ICC ) were calculated for each of the SIS domains , and weighted kappa for individual items . Results — 180 proxy – patient pairs were assessed . Proxies were younger ( mean age : 43.1 versus 57.9 years ) and had a higher education level ( P<0.0001 ) . The bias between patient – proxy mean differences was low ( from 5.3 , Strength , to 0.1 , Communication ) . Proxies significantly scored patients as more severally affected in Strength ( 41.7 versus 36.6 ; P<0.0001 ) and ADL ( 46.2 versus 43.1 ; P=0.01 ) domains , and Composite Physical Domain ( CPD ; 39.7 versus 34.9 ; P<0.0001 ) . The magnitude of difference was small ( size effect : 0.21 ) . ICC values for the SIS domains ranged from 0.17 ( Emotion ) to 0.79 ( H and function ) . The ICC value for the CPD was 0.83 . Memory , Communication , Emotion , and Social Participation domains had ICC lower values . The weighted kappa values for the SIS items ranged from 0.09 ( item 4e ) to 0.80 ( item 7d ) . Highest values ( moderate/high agreement ) were observed for the SIS-16 and CPD ( kappa values : 0.31 to 0.80 ) . Conclusions — Agreement between stroke patients and proxies was acceptable for most SIS domains and SIS-16 . Proxy ’s assessment of SIS subjective domains should be taken with caution Background The COPD ( chronic obstructive pulmonary disease ) assessment test ( CAT ) is a recently introduced , simple to use patient-completed quality of life instrument that contains eight questions covering the impact of symptoms in COPD . It is not known how the CAT score performs in the context of clinical pulmonary rehabilitation ( PR ) programmes or what the minimum clinical ly important difference is . Methods The introduction of the  CAT score as an outcome measure was prospect ively studied by PR programmes across London . It was used alongside other measures including the St George 's Respiratory Question naire , the Chronic Respiratory Disease Question naire , the Clinical COPD Question naire , the Hospital Anxiety and Depression score , the Medical Research Council ( MRC ) dyspnoea score and a range of different walking tests . Patients completed a 5-point anchor question used to assess overall response to PR from ‘ I feel much better ’ to ‘ I feel much worse ’ . Results Data were available for 261 patients with COPD participating in seven programmes : mean ( SD ) age 69.0 ( 9.0 ) years , forced expiratory volume in 1 s ( FEV1 ) 51.1 ( 18.7 ) % predicted , MRC score 3.2 ( 1.0 ) . Mean change in CAT score after PR was 2.9 ( 5.6 ) points , improving by 3.8 ( 6.1 ) points in those scoring ‘ much better ’ ( n=162 ) , and by 1.3(4.5 ) in those who felt ‘ a little better ’ ( n=88 ) ( p=0.002 ) . Only eight individuals reported no difference after PR and three reported feeling ‘ a little worse ’ , so comparison with these smaller groups was not possible . Conclusion The CAT score is simple to implement as an outcome measure , it improves in response to PR and can distinguish categories of response Background Chronic obstructive pulmonary disease ( COPD ) impairs quality of life and leads to premature mortality . COPD sufferers experience progressive deterioration of lung function and decreased ability to undertake day-to-day activities . Ginseng has been used for thous and s of years in Chinese medicine for respiratory symptoms . Several controlled clinical trials using ginseng for COPD have shown promising clinical effect , however these studies were generally small and with some potential bias , prompting the need for rigorously design ed studies . Aim The objective of this study is to evaluate the therapeutic value and safety profile of a st and ardised root extract of Panax ginseng C.A Meyer ( ginseng ) for symptomatic relief , with a focus on quality of life ( QoL ) improvements in individuals with moderate ( Stage II ) COPD FEV1/FVC < 0.7 and FEV1 50 % - 80 % predicted . Methods This paper describes the design of a r and omised , multi-centre , double-blind , placebo controlled , two-armed parallel clinical trial . Two trial sites in Melbourne Australia will proportionately r and omise a total of 168 participants to receive either ginseng capsule ( 100 mg ) or matching placebo twice daily for 24 weeks . The primary outcomes will be based on three vali date d QoL question naires , St Georges Respiratory Question naire ( SGRQ ) , Short Form Health Survey ( SF-36 ) and the COPD Assessment Test ( CAT ) . Secondary outcomes are based on lung function testing , relief medication usage and exacerbation frequency and severity . Safety endpoints include blood tests and adverse event reporting . Intention-to-treat will be applied to all data analyses . Discussion Findings from this study may lead to new therapeutic development for chronic respiratory diseases , particularly COPD . This protocol may also guide other investigators to develop quality herbal medicine clinical trials in the future . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : BACKGROUND Marital adjustment has been associated with morbidity and mortality across various chronic diseases but has been largely ignored among patients with chronic obstructive pulmonary disease ( COPD ) . PURPOSE This study was design ed to evaluate the relationship among marital adjustment , quality of life , psychologic functioning , and functional capacity among married patients with COPD who are participating in a 5-week exercise rehabilitation program and their spouses . SAMPLE A convenience sample of 31 patients with COPD and their partners was included . DESIGN A prospect i ve 1-group pretest-posttest study was conducted . RESULTS Marital adjustment scores indicated that patients and partners were , on average , satisfied with their marriages . Patient marital adjustment was associated with patient psychologic well-being , whereas partner marital adjustment was associated with patient physical functioning . In addition , patient and partner perceptions of marital adjustment predicted change in patient functioning after exercise rehabilitation . Patients who entered the program with poor marital adjustment experienced a greater magnitude of improvement in mental health after rehabilitation than did well-adjusted patients . CONCLUSIONS These findings suggest that marital adjustment is associated with both psychologic well-being and physical functioning among patients with COPD , and that it may predict change among patients with COPD participating in exercise rehabilitation OBJECTIVE The purpose of this study was to evaluate the influence of rollator use on health-related quality of life in patients with COPD . DESIGN R and omized controlled trial . METHODS Thirty-one postrehabilitation patients with COPD were r and omized to receive a  rollator ( n = 18 ) or  usual care  ( n = 13 ) for 8 weeks and to record the frequency of rollator use . Outcome measures at baseline , 4 weeks , and 8 weeks included the Chronic Respiratory Question naire ( CRQ ) and the 6-min walk ( 6MW ) . RESULTS During acute testing , subjects consistently walked further when assisted ( baseline 6MW : 292 + /- 67 m vs 263 + /- 67 m ; 8 weeks : 283 + /- 65 m vs 259 + /- 68 m [ + /-SD ] ; p = 0.013 ) . However , provision of a rollator at home was not associated with group differences in the CRQ ( p > 0.08 ) or in the unassisted 6MW ( p = 0.4 ) or the assisted 6MW ( p = 0.5 ) . Eight of 18 subjects assigned to the rollator group used the rollator less than three times per week . Regular users demonstrated a consistent improvement in mastery compared with infrequent users ( 4 weeks : 4.7 + /- 0.6 vs 5.2 + /- 0.8 , respectively ; 8 weeks : 5.3 + /- 0.8 vs 4.7 + /- 0.4 ; p = 0.014 ) . CONCLUSIONS Despite evidence of effectiveness during acute testing , this study did not demonstrate a rollator effect on quality of life or exercise capacity when the rollator was provided at home , for a longer period . Actual use of a rollator may be an important determinant of its effect . Therefore , when prescribing a rollator , health-care professionals should attempt to identify those most likely to use it OBJECTIVE To document outcomes of a r and omized trial of the PhoenixCare demonstration program of palliative care and coordinated care/case management for seriously chronically ill individuals who simultaneously received active treatment from managed care organizations ( MCOs ) . DESIGN Patients , continuously enrolled between July 1999 , and March 2001 , were r and omly assigned to the PhoenixCare program  or a control group receiving usual MCO care . SETTING Hospice of the Valley , Phoenix , Arizona . PARTICIPANTS Participants were 192 patients with chronic obstructive pulmonary disease ( COPD ) or chronic heart failure ( CHF ) , who had an estimated 2-year life expectancy . INTERVENTION Intensive home-based case management provided by registered nurse casemanagers , in coordination with patients ' existing source of medical care , comprised the intervention . Program foci included disease and symptom management , patient self-management of illness and knowledge of illness-related re sources , preparation for end-of life , physical and mental functioning , and utilization of medical services . OUTCOME MEASURES Outcomes , assessed every 3 months by telephone interview , included measures related to all program foci ; the SF-36 was used to evaluate physical and mental functioning ; emergency department visits exemplified medical service utilization . RESULTS Compared to controls , PhoenixCare patients exhibited significantly better outcomes on self-management of illness , awareness of illness-related re sources , and legal preparation for end of life . They reported lower symptom distress , greater vitality , better physical functioning and higher self-rated health than r and omized controls . Emergency department utilization was equivalent across groups . Patients with COPD showed stronger responsiveness to the intervention . CONCLUSION A novel model of patient care that combined greatly enhanced palliative carefocused case management with ongoing MCO-based treatment was associated with improved functioning of chronically severely ill patients in the last years of life STUDY OBJECTIVE Measures of health-related quality of life ( HRQL ) correlate with disease stage in persons with COPD . However , as their predictive capacity for mortality or medical utilization is less well defined , we sought to examine the relationship of a general measure of HRQL and outcomes in persons with obstructive lung disease . DESIGN Prospect i ve cohort study . SETTING Upper Midwest Veterans Integrated Service Network (VISN)-13 . PARTICIPANTS All veterans in VISN-13 ( n = 70,017 ) were surveyed with the Veterans Short Form 36 ( SF-36V ) .  Persons with reported asthma or COPD who completed the SF-36V formed the study cohort ( n = 8,354 ) . MEASUREMENTS AND RESULTS For purpose s of analysis , individuals were divided into quartiles of HRQL according to their physical component summary ( PCS ) and mental component summary ( MCS ) , values derived from the SF-36V . Outcomes of mortality , hospitalization , and outpatient visits were recorded for 12 months after the survey . Outpatient utilization was dichotomized into high vs low use , with high use being defined as the upper quartile of visits in the 12 months prior to survey mailing . The study cohort had a mean age of 65 years and was largely male ( 95 % ) , both consistent with a veteran population . After correcting for potential confounding factors through multivariable regression , the PCS was independently predictive of death , hospitalization , and high outpatient utilization . When using the first quartile of PCS as the reference population , those in the fourth quartile of PCS had a hazard ratio for death of 5.47 ( 95 % confidence interval [ CI ] , 3.63 to 8.26 ) . Similarly , the odds ratios for hospitalization , high primary care visits , and high specialty medicine visits in the fourth quartile of PCS were 1.82 ( 95 % CI , 1.51 to 2.19 ) , 1.54 ( 95 % CI , 1.26 to 1.87 ) , and 1.46 ( 95 % CI , 1.21 to 1.78 ) , respectively . The MCS , through multivariable regression , was predictive of death but unassociated with subsequent hospitalization or high outpatient utilization . CONCLUSION HRQL , as assessed by the SF-36V , is an independent predictor of mortality , hospitalization , and outpatient utilization in persons with self-reported obstructive lung disease Clinical manifestations of chronic obstructive pulmonary disease ( COPD ) , including airflow limitation , dyspnea , and activity limitation , ultimately lead to impaired health-related quality of life ( HRQoL ) . This 9-month , r and omized , double-blind , multicenter study compared the effect of once-daily tiotropium 18 μg and placebo on HRQoL , spirometric parameters , and exacerbations in 554 patients with moderate-to-severe COPD .  HRQoL was assessed using the St. George ’s Respiratory Question naire ( SGRQ ) and the new 8-item Visual Simplified Respiratory Question naire ( VSRQ ) , which is currently being vali date d. The primary efficacy endpoint was the proportion of patients achieving a reduction of at least 4 units in the SGRQ total score at study end ( Month 9 ) . Mean ± SD baseline SGRQ total score was 47.4 ± 18.1 . Significantly more tiotropium-treated patients achieved a reduction of at least 4 units in the SGRQ score  vs placebo at study end ( 59.1 % vs 48.2 % , respectively ;  p = 0.029 ) . Tiotropium  significantly improved spirometric parameters ( forced expiratory volume in 1 second [ FEV1 ] : 0.11 ± 0.02 L vs 0.01 ± 0.02 L ; between-group difference : 0.10 ± 0.03 L , p = 0.0001 ) and reduced exacerbations vs placebo . Maintenance treatment with tiotropium provided significant and clinical ly relevant improvements in HRQoL , as measured by the SGRQ STUDY OBJECTIVES Previous studies with short recall periods have suggested that informed administration ( previous responses available ) may improve the responsiveness and validity of health-related quality -of-life ( HRQL ) question naires in comparison to blind administration ( previous responses unavailable ) . Informed administration may , however , have less impact in studies with longer recall periods . The objective of this r and omized trial was to compare the validity and responsiveness of the blind and informed Chronic Respiratory Question naire ( CRQ ) and the St. George 's Respiratory Question naire ( SGRQ ) with a 3-month interval between question naire completion . STUDY DESIGN We r and omized 85 patients to blind or informed administration of the CRQ and SGRQ before and after they underwent a st and ard respiratory rehabilitation program . Patients also completed other HRQL instruments . RESULTS At the follow-up administration , we observed important and statistically significant improvement in all four CRQ domains and three SGRQ domains . The results of blind and informed administration differed little . This was true for both the CRQ and the SGRQ , and for both responsiveness and validity . CONCLUSIONS In contrast to the improved measurement properties after shorter recall periods , the administration of the informed version after > or = 12 weeks may not result in improvements in responsiveness or validity There is need for a vali date d short , simple instrument to quantify chronic obstructive pulmonary disease ( COPD ) impact in routine practice to aid health status assessment and communication between patient and physician . Current health-related quality of life question naires provide valid assessment of COPD , but are complex , which limits routine use . The aim of the present study was to develop a short vali date d  patient-completed  question naire , the  COPD Assessment Test ( CAT ) , assessing the impact of COPD on health status . 21 c and i date items identified through qualitative research with COPD patients were used in three prospect i ve international studies ( Europe and the USA , n = 1,503 ) . Psychometric and Rasch analyses identified eight items fitting a unidimensional model to form the CAT . Items were tested for differential functioning between countries . Internal consistency was excellent : Cronbach 's α = 0.88 . Test re-test in stable patients ( n = 53 ) was very good ( intra-class correlation coefficient 0.8 ) . In the sample from the USA , the correlation with the COPD -specific version of the St George ’s Respiratory Question naire was r = 0.80 . The difference between stable  ( n = 229 ) and  exacerbation patients ( n = 67 ) was five units of the 40-point scale ( 12 % ; p<0.0001 ) . The CAT is a short , simple question naire for assessing and monitoring COPD . It has good measurement properties , is sensitive to differences in state and should provide a valid , reliable and st and ardised measure of COPD health status with worldwide relevance BACKGROUND Retinoids promote alveolar septation in the developing lung and stimulate alveolar repair in some animal models of emphysema . METHODS One hundred forty-eight subjects with moderate-to-severe COPD and a primary component of emphysema , defined by diffusing capacity of the lung for carbon monoxide ( Dlco ) [ 37.1 + /- 12.0 % of predicted ] and CT density mask ( 38.5 + /- 12.8 % of voxels < - 910 Hounsfield units ) [ mean + /- SD ] were enrolled into a r and omized , double-blind , feasibility study at five university hospitals . Participants received all-trans retinoic acid ( ATRA ) at either a low dose ( LD ) [ 1 mg/kg/d ] or high dose ( HD ) [ 2 mg/kg/d ] , 13-cis retinoic acid ( 13-cRA ) [ 1 mg/kg/d ] , or placebo for 6 months followed by a 3-month crossover period . RESULTS No treatment was associated with an overall improvement in pulmonary function , CT density mask score , or health-related quality of life ( QOL ) at the end of 6 months . However , time-dependent changes in Dlco ( initial decrease with delayed recovery ) and St. George Respiratory Question naire ( delayed improvement ) were observed in the HD-ATRA cohort and correlated with plasma drug levels . In addition , 5 of 25 participants in the HD-ATRA group had delayed improvements in their CT scores that also related to ATRA levels . Retinoid-related side effects were common but generally mild . CONCLUSIONS No definitive clinical benefits related to the administration of retinoids were observed in this feasibility study . However , time- and dose-dependent changes in Dlco , CT density mask score , and health-related QOL were observed in subjects treated with ATRA , suggesting the possibility of exposure-related biological activity that warrants further investigation Study objectives The aims of this study were to establish whether pulmonary rehabilitation ( PR ) improves domestic function and daily activity levels in COPD and whether individually targeted exercise is more effective than general exercise . Design Prospect i ve r and omized , controlled trial . Setting Outpatient PR program in secondary care . Participants One-hundred eighty patients ( mean [ ±SD ] age , 68.3 ± 8.6 years ; FEV 1 , 0.95 ± 0.4 L ; FEV 1 /FVC ratio , 0.51 ± 0.15 ; 111 male patients ; 69 female patients ) with stable COPD . One hundred twenty-one patients completed the study . Interventions Patients were r and omized to a conventional 7-week general exercise program ( [ GEP ] n=90 ) or an individually targeted exercise program ( [ ITEP ] n=90 ) . Measurement and results Daily activity was measured using ambulatory activity monitors ( Z80 –32k V1 Int ; Gaehwiler Electronics ; Hombrechtikon , Switzerl and ) . These were lightweight devices , which contained a uniaxial accelerometer . Domestic function was assessed by the Canadian Occupational Performance Measure ( COPM ) . Exercise performance was assessed by the incremental shuttle walk test ( ISWT ) and the endurance shuttle walk test and health status by the chronic respiratory question naire – self-reported . Activity monitor counts increased by 29.18 % ( 95 % confidence interval [ CI ] , 3.19 to 55.17 ; p=0.03 ) for the GEP and 40.63 % ( 95 % CI , 7.42 to 73.83 ; p=0.02 ) for the ITEP . Mean COPM performance scores increased by 1.71 ( 95 % CI , 1.37 to 2.05 ; p=0.0001 ) for the GEP and 1.46 ( 95 % CI , 1.05 to 1.87 ; p=0.0001 ) for the ITEP . Mean COPM satisfaction scores increased by 2.27 ( 95 % CI , 1.74 to 2.81 ; p=0.0001 ) for the GEP and 2.04 ( 95 % CI , 1.56 to 2.52 ; p=0.0001 ) for the ITEP . ISWT scores increased by 81.72 m ( range , 63.83 to 99.62 ) for the GEP and by 85.52 m ( range , 67.62 to 103.42 ) for the ITEP . No statistically significant difference was found between the general exercise group and the individually targeted exercise group for any outcome measure . Conclusions Pulmonary rehabilitation improves domestic function and physical activity . This study also demonstrates that general exercise training is as effective as individually targeted training STUDY OBJECTIVES Several vali date d instruments are used to measure outcomes , such as exercise performance , dyspnea , and health-related quality of life after pulmonary rehabilitation ( PR )  in patients with COPD . However , no study has simultaneously compared the responsiveness of the most frequently used outcome measurements after PR . We design ed this study to investigate the capacity of several of the most frequently used outcome measurements to detect changes after PR in a population of patients with severe COPD who qualified for lung volume reduction surgery . DESIGN , PATIENTS , AND INTERVENTIONS We evaluated 37 patients with severe COPD ( FEV(1 ) < 40 % ) before and after 6 to 8 weeks of outpatient PR .  The following frequently used tools were evaluated : the  6-min walk distance ( 6MWD ) ; functional dyspnea with the Medical Research Council ( MRC ) scale ; baseline and transitional dyspnea index ( BDI/TDI ) ; resting and 6MWD visual analog scale ( VAS ) ; quality of life with a generic tool ( the Short Form-36 [ SF-36 ] ) ; and two disease-specific tools , the Chronic Respiratory Disease Question naire ( CRQ ) and the St. George 's Respiratory Question naire ( SGRQ ) . RESULTS After PR , mean + /- SD 6MWD increased in 33 of 37 patients ( 89 % ) , from 285 + /- 97 to 343 + /- 92 m ( p = 0.009 ) . Improvements were seen also in the MRC scale in 23 of 37 patients ( 62 % ; from 2.27 + /- 0.8 to 1.86 + /- 0.6 ; p = 0.01 ) ; in CRQ dyspnea in 25 of 37 patients ( 67 % ; from 3.25 + /- 0.9 to 3.90 + /- 1.4 ; p = 0.02 ) ; in CRQ mastery in 22 of 37 patients ( 60 % ; from 4.37 + /- 1.4 to 5.14 + /- 1.3 ; p = 0.01 ) ; and in BDI/TDI functional in 24 of 37 patients ( 64 % ; from 1.4 + /- 0.8 to 0.7 + /- 1.1 ; p = 0.002 ) . There were smaller improvements in the SGRQ in 18 of 37 patients ( 48 % ) and in the SF-36 in 19 of 37 patients ( 51 % ) , but they were not statistically significant . There were good correlations between the dyspnea components of all the tools . The 6MWD change did not correlate with the changes in the other outcomes . Clinical ly significant changes in the values for those outcome tools were detected in > 50 % of patients for the BDI/TDI , 29 % of patients for the MRC scale , in 37 % of patients for the 6MWD , in 48 % of patients for the VAS at peak exercise , in > 50 % of patients for the CRQ , and in 40 % of patients for the SGRQ . CONCLUSIONS We conclude that the VAS peak exercise , BDI/TDI , and CRQ adequately reflect the beneficial effects of PR . The 6MWD evaluates a unique domain not related to quality of life . Due to their simplicity and sensitivity , VAS at peak exercise , 6MWD , and CRQ may be the best practical tools to evaluate responsiveness to PR BACKGROUND The exacerbations of chronic obstructive pulmonary disease tool ( EXACT ) is a condition-specific daily diary recently developed to evaluate the frequency , severity , and duration of chronic obstructive pulmonary disease ( COPD ) exacerbations . A preference-based algorithm for the EXACT would allow utilities to be reported from patients during an exacerbation when EQ-5D data are not available . OBJECTIVE To develop the exacerbations of chronic obstructive pulmonary disease tool-utility ( EXACT-U ) , a condition-specific preference-based measure to report utilities from the EXACT for use in cost-effectiveness studies . METHODS Five items with three to five levels comprise the EXACT-U. Two groups of health states and respondents were constructed to allow for model development ( Development group ) and predictive validity testing ( Validation group ) using independent sample s. Members of the UK general public each valued 11 r and omized health states using time trade-offs ( TTOs ) scaled from full health/dead with 10-year duration s. Regression models estimated from the Development group using individual data , mean data , and panel design s. Models assessed by number of inconsistent coefficients estimated and R(2 ) and tested against observed utilities from the Validation group using mean absolute error ( MAE ) and root mean squared error ( RMSE ) . RESULTS A total of 55 health states , including the best and worst states , were valued in TTO interviews conducted with 400 respondents . Ten models were developed . The final preferred model contained no logical inconsistencies and found MAE = 0.04 and RMSE = 0.05 with a predicted utility range from 0.09 to 0.95 . CONCLUSIONS The EXACT-U is a condition-specific preference-based measure with strong predictive validity to report daily utilities during an exacerbation Adding a long-acting beta(2)-agonist ( LABA ) by dry powder inhaler ( DPI ) to tiotropium provides significantly increased and sustained bronchodilation in chronic obstructive pulmonary disease ( COPD ) patients over either product alone . To demonstrate similar benefits with a nebulized LABA , a placebo-controlled trial was conducted to evaluate the efficacy and safety of formoterol fumarate inhalation solution in subjects receiving tiotropium as a maintenance treatment for COPD . After a 7 - 14-day screening period using tiotropium 18 microg once daily , subjects with diagnosed COPD ( > or = 25 % to < 65 % predicted FEV(1 ) ) were r and omized to receive 20 microg formoterol fumarate inhalation solution twice daily for nebulization plus tiotropium ( FFIS/TIO ) or nebulized placebo twice daily plus tiotropium ( PLA/TIO ) for 6 weeks . Efficacy was assessed with spirometry at each visit ( Day 1 , Week 1 , 3 , 6 ) , the transition dyspnea index ( TDI ) , and St. George 's Respiratory Question naire ( SGRQ ) . Baseline characteristics were comparable , including mean FEV(1)% predicted . At Week 6 , FEV(1 ) AUC(0 - 3 ) was 1.52 L for FFIS/TIO-treated subjects vs. 1.34 L for PLA/TIO-treated subjects ( p<0.0001 ) . The mean TDI scores in the FFIS/TIO and PLA/TIO groups were 2.30 and 0.16 , respectively ( p=0.0002 ) . SGRQ did not change significantly with 6 weeks treatment , with the exception of FFIS/TIO improvements in symptom score vs. PLA/TIO ( p=0.04 ) . More PLA/TIO- than FFIS/TIO-treated subjects experienced AEs ( 39.7 % vs. 22.9 % ) , COPD exacerbations ( 7.9 % vs. 4.5 % ) , and serious AEs ( 3.2 % vs. 1.5 % ) . Nebulized formoterol fumarate in combination with tiotropium provided statistically and clinical ly significant improvements in bronchodilation and symptom control over tiotropium alone and demonstrated good tolerability OBJECTIVE To determine the feasibility of distractive auditory stimuli ( DAS ) used during an upper extremity training ( UET ) program on perceived dyspnea , functional performance , and health-related quality of life . In addition , to determine the appropriate music tempo used during the UET . DESIGN Experimental , r and omized , 3-group design with testing at baseline and 4 weeks . SETTING Outpatient . PATIENTS Thirty patients ( 13 male and 17 female ) with moderate to severe chronic obstructive pulmonary disease ( FEV1 41.27 % + /- 18 % predicted ) . INTERVENTION Moderate DAS group ( n = 10 ) and slow DAS group ( n = 10 ) subjects were instructed to perform UET for up to 15 minutes 3 to 5 times a week using DAS ( walkman , audiocassettes ) . The control group ( n = 10 ) received the same instructions , but no DAS . MEASURES AND RESULTS Primary outcome measures were perceived dyspnea , functional performance using the 6-minute peg and ring board ( 6MRPB ) count and health-related quality of life . In addition , all subjects recorded the time of UET performance using self-report ( daily logs ) . A significant increase was seen in 6MRPB count ( P = .002 ) between groups . Moderate DAS subjects increased 6MPRB count 46 + /- 21 rings and slow DAS subjects increased 46 + /- 20 rings from baseline to 4 weeks whereas control subjects increased only 5 + /- 4 rings . No significant differences were noted for the remaining variables . CONCLUSION Subjects who used DAS ( music ) while performing UET improved functional performance whereas controls failed to continue improvement . The DAS is a feasible adjunct to UET that may have the potential to augment the effectiveness of pulmonary rehabilitation training This report concerns the development and validation of two patient-reported outcomes question naires developed to assess chronic obstructive pulmonary disease ( COPD ) patients ’ ability to perform morning activities and to evaluate their morning symptoms . Based on interviews with COPD patients , the Capacity of Daily Living during the Morning ( CDLM ) question naire and the Global Chest Symptoms Question naire ( GCSQ ) were developed , linguistically vali date d and incorporated into two multicentre , r and omised trials involving a total of 1,100 COPD patients ; those trials were registered at Clinical Trials.gov ( NCT00496470 and NCT00542880 ) . Data from these trials were used to determine the reliability , validity and responsiveness of the question naires and to derive estimates of minimal important differences ( MIDs ) . Both question naires displayed good-to-high reliability ( Cronbach ’s & agr ; 0.75–0.93 ) . Analysis of convergent validity showed that CDLM and GCSQ scores correlated significantly ( p<0.001 ) with symptoms , health-related quality of life ( HRQoL ) and use of rescue medication . In both trials , CDLM and GCSQ scores discriminated between patients with different levels of HRQoL , as assessed by the St George 's Respiratory Question naire for COPD patients ( SGRQ-C ) , but not with disease severity , as assessed by the Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) criteria . A significant improvement in CDLM and GCSQ scores occurred in response to treatment . Estimations of MID scores , corresponding to an SGRQ-C MID of 4 , were 0.20 for the CDLM question naire and 0.15 for the GCSQ . Both the CDLM question naire and the GCSQ are easy-to-use , reliable , responsive , self-administered question naires that report on patients ' symptoms and ability to perform morning activities Chronic obstructive pulmonary disease ( COPD ) is a major cause of morbidity in old age . It leads to reduced quality of life ( QoL ) , but the factors that contribute to this are less understood . There is no consensus on measurement of QoL in elderly COPD patients . We assessed ( a ) factors predicting QoL in elderly COPD out- patients and ( b ) specificity ( SP ) , sensitivity ( SEN ) , positive and negative predictive values ( PPV and NPV ) and repeatability of two disease-specific QoL instruments , the Chronic Respiratory Disease Question naire ( CRQ ) and the Breathing Problems Question naire ( BPQ ) in elderly people . All subjects also completed an  ADL measure [ Nottingham Extended ADL ( NEADL ) ] and a measure of psychological well-being [ Brief Assessment of Depression Cards ( BASDEC ) ] as well as a 6-min walk test .  Subjects comprised 96 ( 56 men ) elderly out- patients with irreversible COPD aged 70 - 93 years ( mean 78 ) who were clinical ly stable for > or = 6 weeks . Controls were 55 ( 23 men ) aged 71 - 90 years ( mean 78 ) with normal lung function . All were cognitively intact .  Mean FEV1/FVC in COPD subjects was 45.5 ( SE = 1.4)% and for controls was 71.4 ( SE = 1.3)% . Repeatability was good for both BPQ and CRQ with no significant difference . There were no significant differences in specificity and positive predictive values between the two question naires but BPQ performed better than CRQ with regard to sensitivity ( P = 0.02 ) and NPV ( P < 0.001 ) . A multiple regression analysis was used to identify variables that best predicted BPQ and CRQ in COPD subjects . For BPQ predictive values were NEADL ( P < 0.0001 ) ; BASDEC ( P < 0.0001 ) ; age ( P < 0.0001 ) ; 6-min walk distance ( P = 0.001 ) ; body mass index ( P < 0.05 ) ; resting oxygen saturation ( P < 0.05 ) ; and household composition ( living alone or with relatives , P = 0.05 ) . In contrast only the following predicted CRQ : NEADL , BASDEC and resting oxygen saturation . Sixteen per cent of the variance in BPQ was accounted for by NEADL score , 9 % by BASDEC , 4 % by age and 3 % by 6-min walk distance ( total r2 = 0.70 ) . It was concluded that : ( 1 ) BPQ provides more valid assessment than CRQ of QoL in elderly COPD subjects ; ( 2 ) severity of disease in terms of its impact on QoL is not predicted by lung function tests ; ( 3 ) the most important determinants of QoL are ADL score and emotional status The optimal method of assessing the effect of treatment on the day-to-day function of patients with chronic airflow limitation is not established . Therefore , we examined the performance of the Six Minute Walk test , a rating of dyspnea following the test and three different question naires measuring dyspnea in daily activities , in a controlled trial of inhaled salbutamol and oral theophylline in 24 patients with primarily fixed chronic airflow limitation . Clinical ly important and statistically significant effects of salbutamol and theophylline on dyspnea during day-to-day activities were detected by each measure , but the Chronic Respiratory Question naire ( CRQ ) appeared more powerful than either the Oxygen Cost Diagram or the Medical Research Council Dyspnea Question naire as modified by the R and Corporation . Changes in the CRQ dyspnea score showed a higher correlation with changes in spirometry , walk test score , dyspnea following the walk test , and global ratings of dyspnea than did the other two measures . Results of the walk test demonstrated statistically significant salbutamol and theophylline effects , but suggested that no added benefit could be obtained with both drugs ; the rating of dyspnea following the walk test , however , was consistent with an additive effect . We conclude that the CRQ is a responsive , valid measure of functional status for clinical trials in chronic lung disease , and that when the six minute walk is used as a measure of outcome , dyspnea following the walk test should be measured BACKGROUND We present a summary report evaluating the efficacy of lung volume reduction surgery ( LVRS ) in patients with advanced emphysema in the Canadian setting . METHODS Quality of Life measures assessed the efficacy of adding LVRS to best medical care including rehabilitation in this blinded r and omized multicentered controlled trial with 2 years of follow-up . Health utility and quality -adjusted life years ( QALY ) were outcomes central to our economic assessment . RESULTS None of the 32 patients r and omized to the LVRS arm or 30 patients in the best medical care ( BMC )  arm crossed-over and no patients were lost to follow-up . Overall surgical mortality was 16 % at 2 years while the overall medical mortality was 13 % ( p = 0.914 ) . There were no 30-day postoperative deaths but 2 deaths ( 6 % ) occurred within 90 days of r and omization . Surgery reduced the residual volume measured at 6 months by 23 % ( 5,385 mL to 4,322 mL , p = 0.007 ) . There was an increase in forced expiratory volume in 1 second ( FEV1 ) of 30 % ( 265 mL , p = 0.013 ) from baseline , an improvement in the six minute walk test ( 6MWT ) of 78 meters ( p = 0.045 ) , and an increase in Health Utility Index 3 ( HUI3 ) which peaked at 6 months with a difference of 0.16 ( p = 0.129 ) . There was a gain in QALYs of 0.21 ( p = 0.19 ) in the LVRS-arm over the BMC -arm . The LVRS  costs an additional 28,119 Canadian dollars ( CAD ) compared with BMC or 133,900 CAD/QALY gained . CONCLUSIONS The addition of LVRS to best medical care including pulmonary rehabilitation improves pulmonary function , exercise activity , and quality of life in selected patients with advanced emphysema . Cost is high but in keeping with other treatment modalities currently available OBJECTIVE To compare the st and ard error of measurement ( SEM ) with established st and ards for clinical ly relevant intra-individual change in an evaluation of health-related quality of life . DESIGN Secondary analysis of data from a r and omized controlled trial . SUBJECTS Six hundred and five out patients with a history of cardiac problems attending the general medicine clinics of a major academic medical center . MEASURES Baseline and follow-up interviews included a modified version of the Chronic Heart Failure Question naire ( CHQ )  and the SF-36 .  The SEM values corresponding to established st and ards for minimal clinical ly important differences ( MCIDs ) on the CHQ were determined . Individual change on the SF-36 was explored using the same SEM criterion . RESULTS One-SEM changes in this population corresponded well to the patient-driven MCID st and ards on all CHQ dimensions ( weighted kappas ( 0.87 ; P < 0.001 ) . The distributions of out patients who improved , remained stable , or declined ( defined by the one-SEM criterion ) were generally consistent between CHQ dimensions and SF-36 subscales . CONCLUSIONS The use of the SEM to evaluate individual patient change should be explored among other health-related quality of life instruments with established st and ards for clinical ly relevant differences . Only then can it be determined whether the one-SEM criterion can be consistently applied as a proxy for clinical ly meaningful change STUDY OBJECTIVES Pulmonary rehabilitation is an established treatment in patients with chronic lung disease but is not widely utilized . Most trials have been conducted in single centers . The National Emphysema Treatment Trial ( NETT ) provided an opportunity to evaluate pulmonary rehabilitation in a large cohort of patients who were treated in centers throughout the United States . DESIGN Prospect i ve observational study of cohort prior to r and omization in a multicenter clinical trial . SETTING University-based clinical centers and community-based satellite pulmonary rehabilitation programs . PATIENTS AND INTERVENTION A total of 1,218 patients with severe emphysema underwent pulmonary rehabilitation before and after r and omization to lung volume reduction surgery ( LVRS ) or continued medical management .  Rehabilitation was conducted at 17 NETT centers supplemented by 539 satellite centers . MEASUREMENTS AND RESULTS Lung function , exercise tolerance , dyspnea , and quality of life were evaluated at regular intervals . Significant ( p < 0.001 ) improvements were observed consistently in exercise ( cycle ergometry , 3.1 W ; 6-min walk test distance , 76 feet ) , dyspnea ( University of California , San Diego Shortness of Breath Question naire score , -3.2 ; Borg breathlessness score : breathing cycle , -0.8 ; 6-min walk , -0.5 ) and quality of life ( St. George Respiratory Question naire score , -3.5 ; Quality of Well-Being Scale score , + 0.035 ; Medical Outcomes Study 36-item short form score : physical health summary , + 1.3 ; mental health summary , + 2.0 ) . Patients who had not undergone prior rehabilitation improved more than those who had . In multivariate models , only prior rehabilitation status predicted changes after rehabilitation . In 20 % of patients , exercise level changed sufficiently after rehabilitation to alter the NETT subgroup predictive of outcome . Overall , changes after rehabilitation did not predict differential mortality or improvement in exercise ( primary outcomes ) by treatment group . CONCLUSIONS The NETT experience demonstrates the effectiveness of pulmonary rehabilitation in patients with severe emphysema who were treated in a national cross-section of programs . Pulmonary rehabilitation plays an important role in preparing and selecting patients for surgical interventions such as LVRS The forced expiratory volume in 1 sec ( FEV1 ) is the most established outcome measure in chronic obstructive pulmonary disease ( COPD ) . However , changes in FEV1 in response to treatment are small in relation to the repeatability of the measurement and there is increasing interest in other measures including markers of lower airway inflammation in induced sputum , assessment of symptoms and health status using visual analogue scores , and question naires . Little is known about the repeatability of these measures or the safety of sputum induction in COPD . We have assessed the safety of sputum induction  in 61 subjects with moderate and severe COPD who participated in a placebo-controlled cross-over study The within-subject repeatability of sputum markers of airway inflammation , health status using the  chronic respiratory disease question naire  ( CRQ ) and  symptom visual analogue scores ( VAS ) were estimated from the data obtained from before and after 2 weeks of treatment with placebo . Sputum induction was performed on 122 occasions and was successful result ing in a cytospin adequate to assess a differential cell count in 95 % of inductions . The group mean ( SEM ) FEV1 was 1.09 (0.05)[41.6 (2.9)% predicted ] and the mean ( SEM ) fall in FEV1 after sputum induction was 120 ml ( 6 ) and % fall 10.9 % ( 0.55 % ) . Seven inductions were stopped due to a fall in FEV1 > 20 % and at a further 13 visits the full sputum induction protocol was not completed due to development of symptoms . The reproducibility of measurements , calculated by the intra-class correlation coefficient , was relatively high for all indices measured ( 0.4 - 0.95 ) with the exception ofthe proportion of lymphocytes ( 0.15 ) and epithelial cells ( 0.3 ) . The ICC for symptom scores and the CRQ domains ranged between 0.87 and 0.96 . In conclusion , sputum induction is safe and the cell and fluid phase mediators repeatable in the investigation of airway inflammation in patients with COPD . VAS symptom scores and the CRQ are reproducible outcome measures in COPD Nebulized solutions of long-acting bronchodilators provide an alternative to DPI and MDI delivery , particularly for COPD patients unable to use h and -held devices easily or correctly . The long-acting beta2-agonist , formoterol fumarate , is differentiated by its onset of significant bronchodilation within 5 min of administration . In a r and omized , double-blind , double-dummy trial , COPD subjects ( n=351 , mean forced expiratory volume FEV1=1.3 L , 44 % predicted ) received nebulized formoterol fumarate ( Perforomist inhalation solution ; FFIS 20 microg ) or DPI ( Foradil Aerolizer ; FA 12 microg ) , or placebo twice daily for 12 weeks . Efficacy was assessed with 12-h pulmonary function tests , and quality of life was assessed before and after treatment with the St. George 's Respiratory Question naire ( SGRQ ) . At the 12-week endpoint , FFIS significantly increased FEV1 AUC0 - 12h relative to placebo ( p<0.0001 ) . No evidence of tachyphylaxis was observed as indicated by maintained FEV1 AUC and reduced rescue albuterol use throughout treatment . FFIS also significantly increased peak FEV1 , trough FEV1 , and st and ardized FVC AUC0 - 12h compared with placebo . SGRQ assessment at Week 12 demonstrated significant and clinical ly meaningful improvements in total score ( FFIS vs placebo , -4.9 , p=0.0067 ) , symptom , and impact scores . No significant differences in efficacy were observed between the two active treatments . Drug related AEs in the FFIS arm with a frequency > or = 1 % and exceeding placebo were dry mouth , nausea , and insomnia . Nebulized FFIS provided significant improvement in respiratory status and quality of life in subjects with COPD relative to placebo and was well tolerated . The efficacy and safety profile of FFIS was comparable to FA DPI OBJECTIVE To assess the psychometric properties of the short-form chronic respiratory disease question naire ( SF-CRQ ) as a quality -of-life ( QOL ) instrument in chronic obstructive pulmonary disease ( COPD ) exacerbations . STUDY DESIGN AND SETTING In a prospect i ve multicenter cohort study , consecutive emergency department ( ED ) patients with COPD exacerbation were interviewed using the SF-CRQ and other instruments . Baseline information was collected in the ED and from follow-up data 2 weeks later . The results of the SF-CRQ were compared with the results of the other instruments and clinical variables by correlation and factor analyses . RESULTS Of the 301 enrolled patients , 80 % reported improvements across each of the domains of the SF-CRQ over the 2-week post-ED period . Overall median changes for the dyspnea , fatigue , emotional function , and mastery domains were 2 , 1 , 1 , and 1.5 , respectively ( P<0.001 for each domain ) . Correlation and factor analyses support their convergent/divergent validity and construct validity . The reliability for the change score of the SF-CRQ was high ( Cronbach 's alpha coefficient , 0.82 ) . Overall minimal clinical ly important difference for improvement in the SF-CRQ was 1.01 ( 95 % confidence interval , 0.72 - 1.31 ) . CONCLUSION SF-CRQ is a valid , reliable , and responsive instrument for the assessment of short-term QOL change in patients with COPD exacerbations BACKGROUND / OBJECTIVES The chronic respiratory question naire ( CRQ ) , the St. Georges Respiratory Question naire ( SGRQ ) , and the feeling thermometer ( FT ) evaluate change in health-related quality of life ( HRQL ) in patients with chronic airflow limitation ( CAL ) . Although the interpretability , and in particular the minimal important difference ( MID ) in score changes , is well established for the CRQ , this is not the case for the SGRQ and FT . The objective of our study is to explore the interpretation of the SGRQ and FT . METHODS We analyzed data from 84 patients who completed the CRQ , SGRQ , and FT before beginning pulmonary rehabilitation and 3 months later . We calculated correlations between the four CRQ domains ( dyspnea , fatigue , emotional function , and mastery ) and the three SGRQ domains ( symptoms , activities , and impact ) , the SGRQ total score , and the FT . When Pearson 's correlations were > /=0.5 , we constructed regression equations and used the slope to calculate the change in SGRQ and FT score that corresponded to a change in CRQ score of 0.5 ( the MID ) . Having established MID for SGRQ we than used a similar approach to examine the relation between the SGRQ and FT results . RESULTS Comparison with the CRQ dyspnea domain suggested the MID in SGRQ total score is approximately 3.05 with a 95 % confidence interval ( 95 % CI ) ranging from 0.39 to 5.71 and a change of 5.67 ( 95 % CI 3.43 - 7.92 ) represents a moderate change ( 1.0 on the CRQ dyspnea domain ) . The MID for the FT based on the CRQ fatigue domain was 6.1 ( 95 % CI 1.87 - 10.28 ) . The FT MID based on the SGRQ activities domain , impacts domain , and total score were , respectively , 7.4 ( 95 % CI 3.44 - 11.35 ) , 5.6 ( 95 % CI 1.6 - 9.64 ) , and 5.9 ( 95 % CI 1.97 - 9.78 ) . CONCLUSIONS An MID for the SGRQ approximates the previously suggested estimate of 4 on a scale of 0 to 100 . The MID for the FT in patients with CAL is approximately 5 to 8 units on the 0 to 100 scale . These MID estimates should facilitate interpretation of clinical trials in which outcome measures include the SGRQ or FT Since the relationships between pulmonary function , exercise capacity , and functional state or quality of life are generally weak , a self report question naire has been developed to determine the effect of treatment on quality of life in clinical trials . One hundred patients with chronic airflow limitation were asked how their quality of life was affected by their illness , and how important their symptoms and limitations were . The most frequent and important items were used to construct a question naire evaluating four dimensions : dyspnoea , fatigue , emotional function , and the patient 's feeling of control over the disease ( mastery ) . Reproducibility , tested by repeated administration to patients in a stable condition , was excellent : the coefficient of variation was less than 12 % for all four dimensions . Responsiveness ( sensitivity to change ) was tested by administering the question naire to 13 patients before and after optimisation of their drug treatment and to another 28 before and after participation in a respiratory rehabilitation programme .  In both cases large , statistically significant improvements in all four dimensions were noted . Changes in question naire score were correlated with changes in spirometric values , exercise capacity , and patients ' and physicians ' global ratings . Thus it has been shown that the question naire is precise , valid , and responsive . It can therefore serve as a useful disease specific measure of quality of life for clinical trials Using clinical and cl aims records from the National Emphysema Treatment Trial , we sought to identify factors that accurately predicted COPD exacerbations . This prospect i ve cohort study consisted of subjects with severe emphysema r and omized to medical therapy .  Exacerbations were defined as a hospitalization or emergency department visit for COPD . Patient characteristics obtained before r and omization were entered as independent variables in multivariable logistic regression models to estimate the risk of exacerbation . Discrimination was determined using the area under the receiver operator characteristic curve ( AUC ) . Baseline measures included demographics , body mass index , pulmonary function , arterial blood gases , radiology studies , dyspnea ( Shortness of Breath Question naire — SOBQ ) , health-related quality of life ( St. George 's Respiratory Question naire — SGRQ ) , 6-minute walk , exercise capacity , medication use , prior exacerbations and co-morbidity . In 610 participants , 26.6 % had a COPD exacerbation over 1-year follow-up . In a model incorporating spirometry , PaO2 , dyspnea , prior exacerbations and co-morbidity , a 5-point decrement in percent predicted FEV1 ( OR 1.16 , 95 % CI 1.00–1.34 ) and a 5-point worsening in SOBQ ( OR 1.08 , 1.02–1.14 ) independently predicted exacerbations ( AUC for full model 0.68 ) . Combining physiologic variables , dyspnea , prior exacerbations and co-morbidity may be useful in identifying patients at high risk for COPD exacerbations PURPOSE To evaluate the differences in the long-term outcomes of dyspnea , exercise performance , health-related quality of life , and health re source utilization following a dyspnea self-management program with 3 different " doses " of supervised exercise . PATIENTS AND METHODS In a prospect i ve , r and omized , single-blind , 1-year trial , patients with stable chronic obstructive pulmonary disease ( N = 103 ; age 66 + /- 8 , females 57 ; FEV1 44.8 % + /- 14 % predicted ) were r and omly assigned to either : ( 1 ) Dyspnea self-management program ( DM ) ; ( 2 ) DM plus 4 supervised exercise sessions ( DM-exposure ) ; or ( 3 ) DM plus 24 supervised exercise sessions ( DM-training ) . The dyspnea self-management program included individualized education and demonstration of dyspnea self-management strategies , an individualized home walking prescription , and biweekly nurse telephone calls . Outcomes were measured at baseline and every 2 months for 1 year . RESULTS The DM-training group had significantly greater improvements in dyspnea during incremental treadmill test and in exercise performance on the incremental and endurance treadmill tests at 6 and 12 months compared with the other 2 groups . Dyspnea with activities of daily living and self-reported physical functioning significantly improved for all groups over time . The dose-response relationship between supervised exercise and improvement in dyspnea present at 2 months was not sustained over the year . CONCLUSION Consistent with previous findings from evaluation studies of pulmonary rehabilitation programs , the greater number of supervised exercise training sessions improved laboratory dyspnea and performance more than the other two doses of exercise . In the long term , the improvement in dyspnea with activities of daily living and physical functioning was similar for all 3 groups Changes in health-related quality of life ( HRQoL ) were evaluated in patients with chronic obstructive pulmonary disease ( COPD ) following treatment with placebo , salmeterol 50 microg twice a day or 100 microg twice a day by metered-dose inhaler . Patients completed the disease-specific St. George 's Respiratory Question naire ( SGRQ ) and the Medical Outcomes Study Short Form 36 ( SF-36 ) at baseline and after 16 wk of treatment . Data from 283 patients ( 95 patients in the placebo group and 94 in each salmeterol group ) were available for HRQoL analysis . Apart from a small difference in ages , all treatment groups were well matched at baseline in terms of forced expiratory volume in one second ( FEV1 ) and HRQoL scores . Compared with placebo , salmeterol 50 microg twice a day was associated with significant improvements in SGRQ " Total " and " Impacts " scores which exceeded the threshold for a clinical ly significant change . This was not seen with salmeterol 100 microg twice a day . Changes in SGRQ and SF-36 scores correlated . They also showed a weak but significant relationship with FEV1 . This study has shown that a modest change in lung function may be associated with clinical ly significant gain in health and well-being in COPD patients BACKGROUND Improvements in health status following  pulmonary rehabilitation ( PR ) diminish with time . Acute exacerbations of COPD ( AE COPD s ) negatively impact adherence after PR and likely accelerate this diminution of benefit . This study was design ed to characterize the pre-AE COPD status of patients with moderate or severe COPD who had completed PR , and then to measure the impact of AE COPD s on health-related quality of life ( HRQL ) and functional exercise capacity . METHODS Sixty subjects who completed PR were enrolled in a 6-month observational study and were followed up until an AE COPD occurred . In the event of an AE COPD , primary outcome measures , the  6-min walk test ( 6MWT ) and the chronic respiratory disease question naire ( CRDQ ) , were repeated 2 weeks after the onset of symptoms . Between-group and repeated- measures analyses were performed . RESULTS The mean ( + /- SD ) age of the 53 subjects ( 49 % female ) completing the study was 68 + /- 9 years . Baseline airflow obstruction was moderate in 35 subjects ( 66 % ) and severe in 18 subjects ( 34 % ) . Thirty-four subjects experienced a moderate or severe AE COPD . The mean distance walked on the baseline 6MWT in those subjects who experienced AE COPD s was 350 + /- 95 m , compared to 416 + /- 95 m walked in those subjects who did not ( difference , 66 m ; p < 0.02 ) . The presence of an AE COPD was associated with significant reductions in 6MWT distance walked ( difference , 59.3 + /- 80 m ; p < 0.01 ) and in the CRDQ domains of fatigue ( difference , 1 + /- 1.3 ; p < 0.01 ) , emotion ( difference , 0.6 + /- 0.95 ; p < 0.01 ) , and mastery ( difference , 0.5 + /- 1.4 ; p < 0.05 ) . CONCLUSIONS Patients with lower functional exercise capacity are more likely to experience AE COPD s following PR . AE COPD s are associated with significant and clinical ly meaningful reductions in functional exercise capacity and HRQL PURPOSE Cancer patients who are deficient in literacy skills are particularly vulnerable to experiencing different outcomes due to disparities in care or barriers to care . Outcomes measurement in low literacy patients may provide new insight into problems previously undetected due to the challenges of completing paper- and -pencil forms . DESCRIPTION OF STUDY A multimedia program was developed to provide a quality of life assessment platform that would be acceptable to patients with varying literacy skills and computer experience .  One item at a time is presented on the computer touchscreen , accompanied by a recorded reading of the question . Various colors , fonts and graphic images are used to enhance visibility , and a small picture icon appears near each text element allowing patients to replay the sound as many times as they wish . Evaluation questions are presented to assess patient burden and preferences . RESULTS An ethnically diverse group of 126 cancer patients with a range of literacy skills and computer experience reported that the ' talking touchscreen ' ( TT ) was easy to use , and commented on the usefulness of the multimedia approach . CLINICAL IMPLICATION S The TT is a practical , user-friendly data acquisition method that provides greater opportunities to measure self-reported outcomes in patients with a range of literacy skills STUDY OBJECTIVES Whereas pulmonary rehabilitation reduces symptoms and improves the quality of life of patients with COPD and is recommended in management guidelines , few patients have access to rehabilitation services . The purpose of this study was to investigate the effectiveness of increasing access to selected components of pulmonary rehabilitation by providing nurse-assisted home care that was composed of patient education , efforts to improve patient self-management skills , and enhanced follow-up . DESIGN We conducted a 6-month , r and omized , controlled trial . SETTING Primary care clinics associated with an urban academic health system . PATIENTS Patients were > or = 45 years of age with a physician diagnosis of COPD , and had a > or = 20-pack-year smoking history , had experienced at least one respiratory symptom during the past 12 months , and had airflow obstruction ( ie , FEV1/FVC ratio , < 70 % ; FEV1 , < 80 % ) . INTERVENTIONS Four nurses were trained in the use of the Global Initiative for Chronic Obstructive Lung Disease guidelines , and two of the four nurses received additional training in collaborative management . Patients were r and omly assigned to usual care ( UC ) , nurse-assisted medical management ( MM ) , or nurse-assisted collaborative management ( CM ) . MEASUREMENTS The main outcome measures were of generic ( Medical Outcome Study 36-item short form [ SF-36 ] , illness intrusiveness ) and disease-specific ( St. George 's respiratory question naire [ SGRQ ] ) quality of life and self-reported health-care utilization . RESULTS Overall , 151 patients ( UC group , 51 patients ; MM group , 49 patients ; and CM group , 51 patients ) completed the study , their average age was 69 years , and 56.9 % were women . The average change in the SF-36 general health domain for the MM group vs the UC group was 1.1 ( 95 % confidence interval [ CI ] , -7.9 to 11.2 ) , and for the CM group vs the UC group the average change was 2.5 ( 95 % CI , -7.0 to 12.3 ) . The corresponding changes in SGRQ total domain were -2.9 ( 95 % CI , -9.8 to 4.1 ) and -2.6 ( 95 % CI , -9.5 to 4.3 ) . There was no change in the number of self-reported emergency department visits or hospitalizations , but the utilization of these services was infrequent . CONCLUSION The findings of our investigation and those from the published literature suggest that interventions to enhance patient education , self-management skills , and follow-up among patients with COPD do not result in clinical ly meaningful improvements in health status or self-reported health-care utilization . Moreover , future studies of disease management programs for patients with COPD need to evaluate interventions that address associated comorbidities , exercise , and social support This study assessed the relative validity of the Medical Outcomes Study Short-Form General Health Survey  ( SF-36 and SF-12 ) for Australian women and compared norms for the independently administered and embedded SF- 12 .  Two sample s of women in New South Wales were r and omly selected from the Medicare data base ( N = 3600 ) . The sample was stratified into young ( 18 to 22 years ) , middle-aged ( 45 to 49 years ) and older ( 70 to 74 years ) women , and into women living in urban ( 40 percent ) , rural ( 30 percent ) and remote ( 30 percent ) areas . In study 3500 households were selected by r and om digit dial . The method was a mailout survey .  SF-36 scale scores were similar to US norms . For the older group , health profiles of the independent and embedded SF- 12 differed . For the SF-36 and independently administered SF- 12 , means differed in all three age groups . The SF-12 physical health scores discriminated between women with poor versus good physical health , and mental health scores discriminated between groups who were or were not psychologically distressed on GHQ-12 . The SF- 36 , relative to the SF-12 , appears to be a more reliable measure for examining changes in health status over time and between groups
target: Conclusion Our findings suggest that people with low literacy skills or learning disabilities are left out of the development of PROMs .
background: Background  Patient-reported outcome measures ( PROMs ) are intended to reflect outcomes relevant to patients .
  They are increasingly used for healthcare quality improvement .
  To produce valid measures , patients should be involved in the development process but it is unclear whether this usually includes people with low literacy skills or learning disabilities .