Meaningful Gait Speed Improvement During the First 60 Days Poststroke: Minimal Clinically Important Difference Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Minimal clinically important differences of 3 patient-rated outcomes instruments. Time dependency of walking classification in stroke. Transcranial direct current stimulation associated with gait training in Parkinson’s disease: A pilot randomized clinical trial Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach. Validation of a consensus-based minimal clinically important difference (MCID) threshold using an objective functional external anchor. Minimal clinically important differences in treadmill, 6-minute walk, and patient-based outcomes following supervised and home-based exercise in peripheral artery disease Minimal clinically important differences in Incontinence Quality-of-Life scores in stress urinary incontinence. Weight loss required by the severely obese to achieve clinically important differences in health-related quality of life: two-year prospective cohort study Determining the minimal clinically important difference for the six-minute walk test and the 200-meter fast-walk test during cardiac rehabilitation program in coronary artery disease patients after acute coronary syndrome. Key Methodological Features of Randomized Controlled Trials of Alzheimer’s Disease Therapy Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. Determination of the minimal clinically important difference in the FIM instrument in patients with stroke. The Minimum Clinically Important Difference of the Patient-rated Wrist Evaluation Score for Patients With Distal Radius Fractures Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Testing minimal clinically important difference: consensus or conundrum? Microvascular decompression for classic trigeminal neuralgia: determination of minimum clinically important difference in pain improvement for patient reported outcomes. Minimal clinically important difference on the Beck Depression Inventory - II according to the patient's perspective Responsiveness and minimal clinically important difference for the EQ-5D in chronic rhinosinusitis.
Background When people with stroke recover gait speed , they report improved function and reduced disability . However , the minimal amount of change in gait speed that is clinical ly meaningful and associated with an important difference in function for people poststroke has not been determined . Objective The purpose of this study was to determine the minimal clinical ly important difference ( MCID ) for comfortable gait speed ( CGS ) associated with an improvement in the modified Rankin Scale ( mRS ) score for people between 20 to 60 days poststroke . Design This was a prospect i ve , longitudinal , cohort study . Methods The participants in this study were 283 people with first-time stroke prospect ively enrolled in the ongoing Locomotor Experience Applied Post Stroke ( LEAPS ) multi-site r and omized clinical trial . Comfortable gait speed was measured and mRS scores were obtained at 20 and 60 days poststroke . Improvement of ≥1 on the mRS was used to detect meaningful change in disability level . Results Mean ( SD ) CGS was 0.18 ( 0.16 ) m/s at 20 days and 0.39 ( 0.22 ) m/s at 60 days poststroke . Among all participants , 47.3 % experienced an improvement in disability level ≥1 . The MCID was estimated as an improvement in CGS of 0.16 m/s anchored to the mRS . Limitations Because the mRS is not a gait-specific measure of disability , the estimated MCID for CGS was only 73.9 % sensitive and 57.0 % specific for detecting improvement in mRS scores . Conclusions We estimate that the MCID for gait speed among patients with subacute stroke and severe gait speed impairments is 0.16 m/s . Patients with subacute stroke who increase gait speed ≥0.16 m/s are more likely to experience a meaningful improvement in disability level than those who do not . Clinicians can use this reference value to develop goals and interpret progress in patients with subacute stroke OBJECTIVE To describe changes in and predictors of comfortable gait speed ( GS-C ) after using a foot-drop stimulator ( FDS ; Bioness L300 ; Bioness Inc , Valencia , CA ) for 42 weeks in persons who had sustained a stroke . DESIGN Secondary analysis of prospect i ve assessment s. SETTING Multicenter clinical trial . PARTICIPANTS A total of 99 subjects who had sustained a stroke ≥ 3 months earlier and who had GS-C ≤ 0.8 m/s and drop foot with a mean age of 60.7 years and a poststroke time of 4.8 years . METHODS GS-C was assessed at baseline and at 30 weeks with and without use of an FDS ( therapeutic effect ) and at 6 , 12 , 30 , 36 , and 42 weeks with use of an FDS ( total effect ) . After subjects participated in 8 physical therapy sessions , an FDS was used for ambulation over the course of 42 weeks . MAIN OUTCOME MEASUREMENTS Changes in mean GS-C over time , FDS " responder " status defined as either ≥ 0.1 m/s gain in GS-C ( the minimal clinical ly important difference [ MCID ] ) or advancing by one Perry Ambulation Category ( PAC ) , and the incidence and nature of adverse events ( AEs ) . RESULTS A total of 74 ( 75 % ) and 69 ( 70 % ) of 99 subjects completed assessment s at 30 weeks and 42 weeks , respectively . Baseline GS-C was 0.42 m/s without use of an FDS and 0.49 m/s with use of an FDS . GS-C improved to 0.54 m/s at 30 weeks without use of an FDS ( effect size = 0.75 ) and 0.54 , 0.55 , 0.58 , 0.60 , and 0.61 m/s at 6 , 12 , 30 , 36 , and 42 weeks with use of an FDS , respectively ( effect size 0.84 at 42 weeks ) . Half of the subjects achieved a maximum GS-C by 12 weeks . Approximately 18 % were PAC responders and 29 % were MCID responders for 30-week therapeutic effect , and 55 % were PAC responders and 67 % were MCID responders for 42-week total effect . After logistic regression , the following factors emerged as the strongest predictors of FDS responders : younger age , faster baseline GS-C and Timed Up and Go , and balance . At 42 weeks , 60 % reported a device-related AE ; 92 % were mild and 96 % were anticipated . CONCLUSIONS When an FDS was used , GS-C improved progressively over 42 weeks , with ≥ 50 % of patients achieving a clinical ly meaningful 42-week total effect and 50 % achieving a maximum GS-C by 12 weeks . Younger patients with greater mobility levels may benefit most from use of an FDS . AEs were frequent , mild , and reversible RATIONALE The 6-minute-walk test ( 6MWT ) is a practical and clinical ly meaningful measure of exercise tolerance with favorable performance characteristics in various cardiac and pulmonary diseases . Performance characteristics in patients with idiopathic pulmonary fibrosis ( IPF ) have not been systematic ally evaluated . OBJECTIVES To assess the reliability , validity , and responsiveness of the 6MWT and estimate the minimal clinical ly important difference ( MCID ) in patients with IPF . METHODS The study population included all subjects completing a 6MWT in a clinical trial evaluating interferon gamma-1b ( n = 822 ) .  Six-minute walk distance ( 6MWD )  and other parameters were measured at baseline and at 24-week intervals using a st and ardized protocol . Parametric and distribution-independent correlation coefficients were used to assess the strength of the relationships between 6MWD and measures of pulmonary function , dyspnea , and health-related quality of life . Both distribution-based and anchor-based methods were used to estimate the MCID . MEASUREMENTS AND MAIN RESULTS Comparison of two proximal measures of 6MWD ( mean interval , 24 d ) demonstrated good reliability ( coefficient = 0.83 ; P < 0.001 ) . 6MWD was weakly correlated with measures of physiologic function and health-related quality of life ; however , values were consistently and significantly lower for patients with the poorest functional status , suggesting good construct validity . Importantly , change in 6MWD was highly predictive of mortality ; a 24-week decline of greater than 50 m was associated with a fourfold increase in risk of death at 1 year ( hazard ratio , 4.27 ; 95 % confidence interval , 2.57- 7.10 ; P < 0.001 ) . The estimated MCID was 24 - 45 m. CONCLUSIONS The 6MWT is a reliable , valid , and responsive measure of disease status and a valid endpoint for clinical trials in IPF BACKGROUND Despite widespread adoption of the six-item erectile function ( EF ) domain of the International Index of Erectile Function ( IIEF ) as a clinical trial end point , there are currently no objective data on what constitutes a minimal clinical ly important difference ( MCID ) in the EF domain . OBJECTIVE Estimate the MCID for the IIEF EF domain . DESIGN , SETTING , AND PARTICIPANTS Anchor-based MCIDs were estimated using data from 17 r and omized , double-blind , placebo-controlled , parallel-group clinical trials of the phosphodiesterase type 5 inhibitor ( PDE5-I ) tadalafil for 3345 patients treated for 12 wk . MEASUREMENTS The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7 : " Over the past 4 weeks , when you attempted sexual intercourse how often was it satisfactory for you ? " MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies ( n=11 ) by comparing patients with and without minimal improvement ( n=863 ) . MCIDs were vali date d in the remaining six studies ( n=377 ) . RESULTS AND LIMITATIONS The ROC-based MCID for the EF domain was 4 , with estimated sensitivity and specificity of 0.74 and 0.73 , respectively . MCIDs varied significantly ( p<0.0001 ) according to baseline ED severity ( mild : 2 ; moderate : 5 ; severe : 7 ) . MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region , ED etiology , and age group . MCIDs did not differ by age group , geographic region , or ED etiology . Current analyses were based on 17 clinical trials of tadalafil . Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies . CONCLUSIONS The context ualization of treatment-related changes in terms of clinical ly relevant improvement is essential to underst and ing treatment efficacy , to interpreting results across studies , and to managing patients effectively . This analysis provides , for the first time , anchor-based estimates of MCIDs in the EF domain score of the IIEF PURPOSE Patient-rated instruments are increasingly used to measure orthopedic outcomes . However , the clinical relevance of modest score changes on such instruments is often unclear . This study was design ed to define the minimal clinical ly important differences ( MCIDs ) of the Disabilities of the Arm , Shoulder , and H and ( DASH ) , QuickDASH ( subset of DASH ) , and Patient-Rated Wrist Evaluation ( PRWE ) question naires for atraumatic conditions of the h and , wrist , and forearm . METHODS We prospect ively analyzed 102 patients undergoing nonoperative treatment for isolated tendinitis , arthritis , or nerve compression syndromes from the forearm to the h and . By phone , patients completed the DASH , QuickDASH , and PRWE at enrollment and at 2 weeks ( n = 78 used in the analysis ) and 4 weeks ( n = 24 used in the analysis ) after initiating treatment . Patients reporting clinical improvement each contributed a single data point categorized as no change ( n = 41 ) , minimal improvement ( n = 30 ) , or marked improvement ( n = 31 ) via a vali date d anchor-based approach . We calculated the MCID as the mean change score for each outcome measure in the minimal improvement group . RESULTS The MCID ( 95 % confidence interval ) for the DASH was 10 ( 5 - 15 ) . The MCID for the QuickDASH was 14 ( 9 - 20 ) . The MCID was 14 ( 8 - 20 ) for the PRWE . The MCID values were significantly different from changes in these outcome measures at times of either no change or marked improvement . The MCID values positively correlated with baseline outcome measure scores to a greater degree than final outcome measure scores . CONCLUSIONS Longitudinal changes on the DASH of 10 points , on the QuickDASH of 14 points , and on the PRWE of 14 points represent minimal clinical ly important changes . We recommend application of these MCID values for group-level analysis when conducting research and interpreting data examining groups of patients as opposed to assessing individual patients . These MCID values may provide a basis for sample size calculations for future investigation using these common patient-rated outcome measures . TYPE OF STUDY /LEVEL OF EVIDENCE Diagnostic III BACKGROUND AND PURPOSE To facilitate optimal stroke rehabilitation , valid interpretation of observed functional recovery is required . The purpose of this study was to examine the longitudinal relationship between comfortable walking speed and  Functional Ambulation Categories ( FAC ) scores for physically independent gait . SUBJECTS This study was a prospect i ve cohort study with 73 subjects who were severely affected by acute stroke . METHODS Functional Ambulation Categories classification and walking speed were measured between weeks 4 and 26 after stroke . The responsiveness of walking speed  measurements for detecting clinical ly important speed changes was determined , and the longitudinal association between walking speed and FAC scores and its time dependency were established . This relationship subsequently was scrutinized for possible speed changes occurring within specific FAC scores . Responsiveness ratios , r and om coefficient analysis , paired Student t tests , and the Cohen kappa statistic were used for statistical analyses . RESULTS Responsiveness ratios exceeded the smallest detectable differences . R and om coefficient analysis demonstrated a significant between- and within-subject coefficient and a significant negative interaction between timing of measurements and FAC scores . Paired Student t tests revealed mostly significant pretest-posttest differences in walking speeds , and all kappa values for pretest-posttest FAC scores were significant . DISCUSSION AND CONCLUSION Walking speed measurements are sensitive for detecting clinical ly important changes . Functional Ambulation Categories scores are dependent on the timing of comfortable walking speed measurements after stroke . Moreover , there are indications that , in this relationship , repeated FAC appraisal s are not only based on steady walking speeds , but that the walking speeds related to a specific FAC appraisal also change and , over time , may shift gradually from higher to lower speeds ABSTRACT Objective : The aim of this study is to investigate the effects of transcranial direct current stimulation ( tDCS ) combined with cueing gait training ( CGT ) on functional mobility in patients with Parkinson´s disease ( PD ) . Methods : A pilot double-blind controlled , r and omized clinical trial was conducted with 22 patients with PD assigned to the experimental ( anodal tDCS plus CGT ) and control  group  ( sham tDCS plus CGT ) . The primary outcome ( functional mobility ) was assessed by 10-m walk test , cadence , stride length , and Timed Up and Go test . Motor impairment , bradykinesia , balance , and quality of life were analyzed as secondary outcomes . Minimal clinical ly important differences ( MCIDs ) were observed when assessing outcome data . Results : Both groups demonstrated similar gains in all outcome measures , except for the stride length . The number of participants who showed MCID was similar between groups . Conclusion : The CGT provided many benefits to functional mobility , motor impairment , bradykinesia , balance , and quality of life . However , these effect magnitudes were not influenced by stimulation , but tDCS seems to prolong the effects of cueing therapy on functional mobility Background Patient-reported outcomes ( PRO ) question naires are being increasingly used in COPD clinical studies . The challenge facing investigators is to determine what change is significant , ie what is the minimal clinical ly important difference ( MCID ) . This study aim ed to identify the MCID for the clinical COPD question naire ( CCQ ) in terms of patient referencing , criterion referencing , and by the st and ard error of measurement ( SEM ) . Methods Patients were ≥40 years of age , diagnosed with COPD , had a smoking history of > 10 pack-years , and were participating in a r and omized , controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD . The CCQ was completed on Days 1–7 and 42 . A Global Rating of Change ( GRC ) assessment was taken to establish the MCID by patient referencing . For criterion referencing , health events during a period of 1 year after Day 42 were included in this analysis . Results 210 patients were recruited , 168 completed the CCQ question naire on Day42 . The MCID of the CCQ total score , as indicated by patient referencing in terms of the GRC , was 0.44 . The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39 , and calculation of the SEM result ed in a value of 0.21 . Conclusion This investigation , which is the first to determine the MCID of a PRO question naire via more than one approach , indicates that the MCID of the CCQ total score is 0.4 OBJECTIVE To identify the minimal clinical ly important difference ( MCID ) for the Montgomery-Asberg Depression Rating Scale ( MADRS ) in r and omised studies of depression , and to cross-vali date the estimated MCID . DESIGN AND METHODS  Placebo-treated patients from three similarly- design ed , 8-week , double-blind , r and omised depression trials with a stable health status between baseline and Week 1 ( ' no change ' rating on the Clinical Global Impression-Improvement scale ) were eligible . To calculate the MCID using the distribution-based approach , the st and ard deviation was estimated using baseline MADRS data while the reliability parameter was measured as the intraclass correlation coefficient between baseline and Week 1 . For cross-validation , patients from an observational study were matched to identify the ' MCID  change ' ( MADRS change from baseline to endpoint score plus the estimated MCID ) and ' control ' groups . Comparisons of clinical and health-related quality of life measures were performed . RESULTS In total , 177 placebo-treated patients were identified .  MCID estimates for MADRS ranged from 1.6 to 1.9 . A total of 105 matched pairs were identified for the cross-validation analyses . Mean change from baseline in MADRS scores ( 10.6 + /- 8.5 vs. 12.5 + /- 7.9 , p = 0.038 ) and remission rates ( 71.6 % vs. 57.1 % , p < 0.05 ) significantly differed between the ' MCID change ' and ' control ' groups at endpoint . Numerically higher response rates and greater improvements in HRQoL scores in the ' MCID change ' group were also found . CONCLUSION These preliminary findings support the value of the estimated MCID for the MADRS and may aid decision makers in evaluating antidepressant treatment effects and improving long-term patient outcomes BACKGROUND CONTEXT The minimal clinical ly important difference ( MCID ) is defined as the smallest change in an outcome that a patient would perceive as meaningful . The Initiative on Methods , Measurement and Assessment in Clinical Trials ( IMMPACT ) group proposed defining the MCID as a 30 % improvement in self-reported pain or function . However , this MCID threshold has not been vali date d against an objective physical measure . PURPOSE To test the validity of the IMMPACT-based MCID threshold , using an objective physical measure as an external anchor . STUDY DESIGN / SETTING Prospect i ve study of chronic disabling occupational lumbar disorder ( CDOLD ) patients completing a functional restoration program . PATIENT SAMPLE A consecutive cohort of 743 CDOLD patients . OUTCOME MEASURES Self-report measures of pain-related function were compared with an objective lifting measure , the progressive isoinertial lifting evaluation ( PILE ) , obtained after treatment . METHODS The association between reporting 30 % or greater improvement ( the IMMPACT 's MCID key criterion ) and the PILE score after treatment was assessed . RESULTS A 30 % or greater improvement on the self-report measures was significantly associated with improvement in physical function on the PILE task . CONCLUSIONS Despite extensive use of the MCID to evaluate effects of treatment in spinal disorders , this is the first empirical documentation of the validity of the IMMPACT 's 30 % change criterion compared with an objective physical anchor We estimated minimal clinical ly important differences ( MCIDs ) for small , moderate , and large changes in measures obtained from a st and ardized treadmill test , a 6-minute walk test , and patient-based outcomes following supervised and home-based exercise programs in symptomatic patients with peripheral artery disease ( PAD ) . Patients were r and omized to either 12 weeks of a supervised exercise program ( n=60 ) , a home-based exercise program ( n=60 ) , or an attention-control group ( n=60 ) . Using the distribution-based method to determine MCIDs , the MCIDs for small , moderate , and large changes in peak walking time ( PWT ) in the supervised exercise group were 38 , 95 , and 152 seconds , respectively , and the changes in claudication onset time ( COT ) were 35 , 87 , and 138 seconds . Similar MCID scores were noted for the home-based exercise group . An anchor-based method to determine MCIDs yielded similar patterns of small , moderate , and large change scores in PWT and COT , but values were 1–2 minutes longer than the distribution approach . In conclusion , 3 months of supervised and home-based exercise programs for symptomatic patients with PAD results in distribution-based MCID small , moderate , and large changes ranging from 0.5 and 2.5 minutes for PWT and COT . An anchor-based approach yields higher MCID values , ranging from a minimum of 73 seconds for COT to a maximum of 4 minutes for PWT . The clinical implication is that a goal for eliciting MCIDs in symptomatic PAD patients through a walking exercise intervention is to increase PWT and COT by up to 4 minutes , which corresponds to two work stages during the st and ardized progressive treadmill test OBJECTIVES To determine the clinical ly relevant reference points for the Incontinence Quality of Life ( I-QOL ) question naire scores in women with stress urinary incontinence and compare them with the treatment effects observed with duloxetine and placebo . METHODS Using data from 1133 women with predominant stress urinary incontinence in two r and omized ,  placebo-controlled duloxetine  studies , the within-treatment and between-treatment minimal clinical ly important differences ( MCIDs ) were obtained by anchoring the I-QOL scores to the vali date d Patient Global Impression of Improvement scale ( PGI-I ) . The within-treatment MCID ( mean I-QOL for women rating their condition " a little better " with treatment ) and between-treatment MCID ( difference in scores between the group ratings of " no change " and " a little better " ) were derived . The treatment effects were compared with these MCIDs . Real-time urinary diaries were completed , along with the I-QOL and PGI-I. RESULTS The within-treatment and between-treatment MCID for the I-QOL total score was 6.3 and 2.5 , respectively . The total and subscale scores had almost identical MCIDs . Duloxetine 80 mg significantly improved the I-QOL total and subscale scores . Treatment differences in the I-QOL scores exceeded the between-treatment MCID and the duloxetine  I-QOL treatment effect exceeded the within-treatment MCID . The number of patients needed to treat to gain an additional I-QOL responder was 6.8 . CONCLUSIONS Improvements in I-QOL scores should be greater than the within-treatment MCID , and differences between two treatments should be greater than the between-treatment MCIDs , for statistically significant differences to be considered clinical ly meaningful . We propose 2.5 points as a reasonable guide for the I-QOL between-treatment MCID and 6.3 points for the within-treatment MCID Background Guidelines and experts describe 5 % to 10 % reductions in body weight as ` clinical ly important ’ ; however , it is not clear if 5 % to 10 % weight reductions correspond to clinical ly important improvements in health-related quality of life ( HRQL ) . Our objective was to calculate the amount of weight loss required to attain established minimal clinical ly important differences ( MCIDs ) in HRQL , measured using three vali date d instruments . Methods Data from the Alberta Population -based Prospect i ve Evaluation of Quality of Life Outcomes and Economic Impact of Bariatric Surgery ( APPLES ) study , a population -based , prospect i ve Canadian cohort including 150 wait-listed , 200 medically managed and 150 surgically treated patients were examined . Two-year changes in weight and HRQL measures ( Short-Form (SF)-12 physical ( PCS ; MCID = 5 ) and mental ( MCS ; MCID = 5 ) component summary score , EQ-5D Index ( MCID = 0.03 ) and Visual Analog Scale ( VAS ; MCID = 10 ) , Impact of Weight on Quality of Life (IWQOL)-Lite total score ( MCID = 12 ) ) were calculated . Separate multivariable linear regression models were constructed within medically and surgically treated patients to determine if weight changes achieved HRQL MCIDs . Pooled analysis in all 500 patients was performed to estimate the weight reductions required to achieve the pre-defined MCID for each HRQL instrument . Results Mean age was 43.7 ( SD 9.6 ) years , 88 % were women , 92 % were white , and mean initial body mass index was 47.9 ( SD 8.1 ) kg/m2 . In surgically treated patients ( two-year weight loss = 16 % ) , HRQL MCIDs were reached for all instruments except the SF-12 MCS . In medically managed patients ( two-year weight loss = 3 % ) , MCIDs were attained in the EQ-index but not the other instruments . In all patients , percent weight reductions to achieve MCIDs were : 23 % ( 95 % confidence interval ( CI ) : 17.5 , 32.5 ) for PCS , 25 % ( 17.5 , 40.2 ) for MCS , 9 % ( 6.2 , 15.0 ) for EQ-Index , 23 % ( 17.3 , 36.1 ) for EQ-VAS , and 17 % ( 14.1 , 20.4 ) for IWQOL-Lite total score . Conclusions Weight reductions to achieve MCIDs for most HRQL instruments are markedly higher than the conventional threshold of 5 % to 10 % . Surgical , but not medical treatment , consistently led to clinical ly important improvements in HRQL over two years . Trial registration Clinical trials.gov NCT00850356 OBJECTIVE To estimate the minimal clinical ly important difference ( MCID ) for the 6-minute walk test ( 6MWT ) and the 200-m fast-walk test ( FWT ) in patients with coronary artery disease ( CAD ) during a cardiac rehabilitation program . DESIGN Prospect i ve study using distribution- and anchor-based methods . SETTING Out patients from a cardiac rehabilitation unit . PARTICIPANTS Stable patients with CAD ( N=81 ; 77 men ; mean±SD age , 58.1±8.7y ) enrolled 31±12.1 days after an acute coronary syndrome ( ACS ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES  6MWT and 200-m FWT results before and after an 8-week cardiac rehabilitation program and at the 6th and 12th sessions . Patients and physiotherapists who supervised the training were asked to provide a global rating of perceived change in walking ability while blinded to changes in walk test performances . RESULTS Mean change in 6MWT distance ( 6MWD ) in patients who reported no change was -6.5 m versus 23.3 m in those who believed their performance had improved ( P<.001 ) . This result was consistent with the MCID determined by using the distribution method ( 23 m ) . Considering a 25-m cutoff , positive and negative predictive values were 0.9 and .63 , respectively . Conversely , there was no difference in 200-m FWT performance between these 2 groups ( 0.1 vs -1.4s , respectively ) . There was poor agreement with the physiotherapist 's perceived change . CONCLUSIONS The MCID for 6MWD in patients with CAD after ACS was 25 m . This result will help physicians interpret 6MWD change and help research ers estimate sample sizes in further studies using 6MWD as an endpoint Background : The results of clinical trials are routinely presented in terms of statistical significance , which may or may not indicate clinical significance . Analysis of the minimal clinical ly important difference ( MCID ) of cognitive scales has received little attention to date . Objectives : By review ing the key method ological features ( sample size , duration , statistical and clinical significance ) of clinical trials examining the efficacy of tacrine in the treatment of Alzheimer ’s disease ( AD ) , we assessed their ability to detect clinical ly important changes in cognition . Design : The value for the MCID of the  Mini-Mental State Examination ( MMSE )  was determined by surveying specialists in neurology and geriatric medicine . This value was then used to interpret the clinical significance of the results of published r and omized controlled trials ( RCTs ) assessing the efficacy of tacrine in the treatment of AD and to retrospectively determine their optimal sample size and trial duration . Results : The mean survey MCID for the MMSE was 3.72 ( 95 % confidence interval 3.50–3.95 ) points . Only 2 of 12 tacrine RCTs using the MMSE found a statistically significant difference in MMSE scores for patients taking tacrine  compared with those taking placebo . These improvements were not clinical ly significant when compared with the survey MMSE MCID . For parallel trials of tacrine in AD , the smallest sample size and minimum trial duration required to demonstrate a clinical ly significant difference were calculated to be 53 subjects and 1 year , respectively . Five of the 7 parallel trials met the required sample size ; however , none of them met the criteria for trial duration . Conclusions : When using the MMSE as an outcome measure , no tacrine trial reported results that were clinical ly significant as perceived by clinicians working with dementia patients . Application of a range of plausible MCIDs to the parallel design RCTs also demonstrated that 2 of 7 of these trials did not have sufficient sample size , and none had sufficient duration of treatment to reliably detect clinical ly meaningful changes in cognition . Future clinical trials in this area will need to incorporate the evolving knowledge of MCIDs in order to increase their chance of detecting clinical ly relevant results OBJECTIVE To determine the minimal clinical ly important differences ( MCID ) in the patient-reported outcomes of activity ( 0 - 30 , number of days of limitation ) , fatigue ( 0 = none , 100 = complete ) , and sleep quality ( 0 = no problems , 100 = worst case ) for patients with rheumatoid arthritis ( RA ) . METHODS Two r and omized controlled trials comparing abatacept to placebo  in RA patients were considered : ATTAIN ( n = 391 ) and AIM ( n = 652 ) . An internal anchor-based approach was used to derive the MCID using the Health Assessment Question naire , patient global assessment , and pain as anchors . Minimal important change in activity , fatigue , and sleep were determined by estimating mean changes in these outcomes in patients showing change in a narrow range about the MCID of the internal anchor . Correlation analysis was used to determine the consistency of the changes in the outcomes and anchors , and a Delphi process was used to determine the final MCID values . RESULTS For the 2 trials , consistent patterns of change for activity , fatigue , and sleep and the internal anchors were found with correlations in the range of 0.5 , 0.7 , and 0.4 , respectively . The mean changes for activity , fatigue , and sleep in a narrow range about the MCID of the 3 internal anchors corresponding to the 2 trials were : 3.4 to 4.3 for activity ; 6.7 to 17.0 for fatigue ; and 4.1 to 7.3 for sleep . Following the Delphi process the MCID determined were 4 for activity , 10 for fatigue , and 6 for sleep . CONCLUSION These MCID for activity limitation , fatigue , and sleep problems can be used in design ing clinical trials and providing benchmarks in assessing patient improvement OBJECTIVE To define the minimal clinical ly important difference ( MCID ) for the FIM instrument in patients poststroke . DESIGN Prospect i ve case series discharged over a 9-month period . SETTING Long-term acute care hospital . PARTICIPANTS Patients with stroke ( N=113 ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Admission , discharge , and change scores were calculated for the total FIM , motor FIM , and cognitive FIM .  Assessment s of clinical change were rated at discharge on a 15-point ( -7 to + 7 ) Likert scale by attending physicians , with MCID defined at a cutoff score of 3 . The FIM change scores associated with MCID were identified from receiver operating characteristic curves . Bayesian analysis was used to determine the probability of individual patients achieving MCID . RESULTS FIM change scores associated with MCID were 22 , 17 , and 3 for the total FIM , motor FIM , and cognitive FIM , respectively . The accuracy of the  MCID  was greater when subjects were categorized based on admission FIM scores than when considering the sample as a whole . Larger FIM change scores were related to MCID in subjects with lower admission FIM scores . CONCLUSIONS These findings will assist in the interpretation of FIM change scores relative to physicians ' assessment s of important clinical change Background The  Patient-rated Wrist Evaluation ( PRWE ) is a commonly used instrument in upper extremity surgery and in research . However , to recognize a treatment effect expressed as a change in PRWE , it is important to be aware of the minimum clinical ly important difference ( MCID ) and the minimum detectable change ( MDC ) . The MCID of an outcome tool like the PRWE is defined as the smallest change in a score that is likely to be appreciated by a patient as an important change , while the MDC is defined as the smallest amount of change that can be detected by an outcome measure . A numerical change in score that is less than the MCID , even when statistically significant , does not represent a true clinical ly relevant change . To our knowledge , the  MCID  and MDC of the PRWE have not been determined in patients with distal radius fractures . Questions / Purpose sWe asked : ( 1 ) What is the  MCID  of the PRWE score for patients with distal radius fractures ? ( 2 ) What is the MDC of the PRWE ? Methods Our prospect i ve cohort study included 102 patients with a distal radius fracture and a median age of 59 years ( interquartile range [ IQR ] , 48–66 years ) . All patients completed the PRWE question naire during each of two separate visits . At the second visit , patients were asked to indicate the degree of clinical change they appreciated since the previous visit . Accordingly , patients were categorized in two groups : ( 1 ) minimally improved or ( 2 ) no change . The groups were used to anchor the changes observed in the PRWE score to patients ’ perspectives of what was clinical ly important . We determined the MCID using an anchor-based receiver operator characteristic method . In this context , the change in the PRWE score was considered a diagnostic test , and the anchor ( minimally improved or no change as noted by the patients from visit to visit ) was the gold st and ard . The optimal receiver operator characteristic cutoff point calculated with the Youden index reflected the value of the MCID . Results In our study , the MCID of the PRWE was 11.5 points . The area under the curve was 0.54 ( 95 % CI , 0.37–0.70 ) for the pain subscale and 0.71 ( 95 % CI , 0.57−0.85 ) for the function subscale . We determined the MDC to be 11.0 points . Conclusions We determined the MCID of the PRWE score for patients with distal radius fractures using the anchor-based approach and verified that the MDC of the PRWE was sufficiently small to detect our MCID . Clinical Relevance We recommend using an improvement on the PRWE of more than 11.5 points as the smallest clinical ly relevant difference when evaluating the effects of treatments and when performing sample -size calculations on studies of distal radius fractures BACKGROUND CONTEXT The impact of  lumbar spinal surgery  is commonly evaluated with three patient-reported outcome measures : Oswestry Disability Index ( ODI ) , the physical component summary ( PCS ) of the Short Form of the Medical Outcomes Study ( SF-36 ) , and pain scales . A minimum clinical ly important difference ( MCID ) is a threshold used to measure the effect of clinical treatments . Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method . PURPOSE This study has three purpose s. First , to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID . Second , to determine a statistically sound and clinical ly meaningful MCID for ODI , PCS , back pain scale , and leg pain scale in lumbar spine surgery patients . Third , to compare the discriminative ability of two anchors : a global health assessment and a rating of satisfaction with the results of the surgery . STUDY DESIGN This study is a review of prospect ively collected patient-reported outcomes data . PATIENT SAMPLE A total of 454 patients from a large data base of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study . OUTCOME MEASURES Preoperative and 1-year postoperative scores for ODI , PCS , back pain scale , leg pain scale , health transition item ( HTI ) of the SF-36 , and Satisfaction with Results scales . METHODS ODI , SF-36 , and pain scales were administered before and 1 year after spinal surgery . Several c and i date MCID calculation methods were applied to the data and the result ing values were compared . The HTI of the SF-36 was used as the anchor and compared with a second anchor ( Satisfaction with Results scale ) . RESULTS Potential MCID calculations yielded a range of values : fivefold for ODI , PCS , and leg pain , 10-fold for back pain . Threshold values obtained with the two anchors were very similar . CONCLUSIONS The minimum detectable change ( MDC ) appears as a statistically and clinical ly appropriate MCID value . MCID values in this sample were 12.8 points for ODI , 4.9 points for PCS , 1.2 points for back pain , and 1.6 points for leg pain BACKGROUND CONTEXT Various method ologies have been used in attempting to eluci date a st and ard method for calculating minimal clinical ly important difference ( MCID ) . A consensus-based decision ( Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials [ IMMPACT ] group ) suggested a 30 % reduction from baseline as a means to define the MCID of self-report back pain measures . Additionally , important psychometric issues need to be addressed regarding use of an independent measure of the same construct as an external criterion , instead of simply using another self-report measure , when using an anchor-based approach to MCID . PURPOSE The purpose was to test the validity of recently published guidelines regarding MCID using self-report back pain measures and objective socioeconomic outcomes . STUDY DESIGN / SETTING This is a prospect i ve study assessing change scores on commonly used spinal pain assessment measures in patients with chronic disabling occupational spinal disorders ( CDOSDs ) treated in a regional referral rehabilitation center performing interdisciplinary functional restoration . PATIENT SAMPLE The study consisted of consecutive cohort of patients ( N=1,180 ) with CDOSDs completing a functional restoration program . OUTCOMES MEASURES Self-report measures including the Oswestry Disability Index ( ODI ) and the physical component summary ( PCS ) and mental component summary ( MCS ) of the Short Form-36 ( SF-36 ) obtained before and after treatment , were compared with objective socioeconomically relevant outcomes obtained 1 year after treatment ( ie , work status and additional health-care utilization ) , that were the external criteria for evaluating MCID . METHODS Pre- to posttreatment improvement was calculated separately for each measure , and subjects were divided into two groups based on the change in scores relative to baseline : 30 % or greater versus less than 30 % improvement . One-year posttreatment objective socioeconomic outcomes were used as independent external criteria relevant to the CDOSD population . This population is often studied as the most costly and problematic cohort in spine care . RESULTS The ODI and SF-36 MCS were not associated with any of the objective 1-year outcomes used as external criteria . Reduced post-rehabilitation health-care utilization ( based on the percentage of patients pursuing health care from a new provider ) was weakly associated with 30 % or greater improvement on the SF-36 PCS , relative to patients whose scores changed by less than 30 % relative to baseline ( 17.0 % vs. 21.1 % ) . The same was true for the ODI and return-to-work . CONCLUSIONS When objective and independent criteria are used ( socioeconomic outcomes ) in a CDOSD cohort , the 30 % improvement in the ODI and SF-36 may not be a valid MCID index . This replicates similar conclusions made by an independent research group using a distribution-based approach to MCID . The validity of the MCID concept rests on future research using objective external criteria . Moreover , there remains a question whether the term " important " in MCID can be unequivocally and operationally defined as a reliable construct BACKGROUND Outcomes studies use patient-reported outcome ( PRO ) measurements to assess treatment effectiveness , but can lack direct clinical meaning . Minimum clinical ly important difference ( MCID ) calculation provides a point estimate of the critical threshold needed to achieve clinical ly relevant treatment effectiveness . MCID remains uninvestigated for microvascular decompression ( MVD ) , a common surgical procedure for trigeminal neuralgia . OBJECTIVE We aim ed to determine MCID for the most commonly used PRO measures of pain after MVD : Visual Analog Scale ( VAS ) and Barrow Neurological Institute Pain Scale ( BNI-PS ) . METHODS Sixty consecutive patients with classic trigeminal neuralgia who decided to undergo MVD by a single surgeon were prospect ively assessed with  VAS  and BNI-PS preoperatively and 2 years postoperatively . Three anchors were used to assign each patient 's outcome . We then used 3 well-established , anchor-based methods to calculate MCID . RESULTS Patients experienced significant improvement in both VAS ( 9.9 vs. 2.0 , P < .001 ) and BNI-PS ( 5.0 vs. 1.9 , P < .001 ) after MVD . The area under the receiver-operating characteristic curve was greater for BNI-PS than for VAS for all 3 anchors , indicating that BNI-PS is probably better suited for calculating MCID . The 3 MCID calculation methods generated a range of  MCID values for each of the PROs ( VAS : 1.40 - 8.87 , BNI-PS : 0.95 - 3.26 ) . CONCLUSION MVD-specific MCID is highly variable based on calculation technique . Some of these calculations appear to either overestimate or underestimate the patients ' preoperative expectations . When the different MCID methods are averaged , the results are clinical ly appropriate and consistent with preoperative expectations . The average MCID for VAS is 6.25 and for BNI-PS is 2.44 Background The Beck Depression Inventory , 2nd edition ( BDI-II ) is widely used in research on depression . However , the minimal clinical ly important difference ( MCID ) is unknown . MCID can be estimated in several ways . Here we take a patient-centred approach , anchoring the change on the BDI-II to the patient 's global report of improvement . Method We used data collected ( n = 1039 ) from three r and omized controlled trials for the management of depression .  Improvement on a ‘ global rating of change ’ question was compared with changes in BDI-II scores using general linear modelling to explore baseline dependency , assessing whether MCID is best measured in absolute terms ( i.e. difference ) or as percent reduction in scores from baseline ( i.e. ratio ) , and receiver operator characteristics ( ROC ) to estimate MCID according to the optimal threshold above which individuals report feeling ‘ better ’ . Results Improvement in BDI-II scores associated with reporting feeling ‘ better ’ depended on initial depression severity , and statistical modelling indicated that MCID is best measured on a ratio scale as a percentage reduction of score . We estimated a MCID of a 17.5 % reduction in scores from baseline from ROC analyses . The corresponding estimate for individuals with longer duration depression who had not responded to antidepressants was higher at 32 % . Conclusions MCID on the BDI-II is dependent on baseline severity , is best measured on a ratio scale , and the MCID for treatment-resistant depression is larger than that for more typical depression . This has important implication s for clinical trials and practice BACKGROUND The 5-dimensional EuroQol question naire ( EQ-5D ) is vali date d to measure general health-related quality of life ( QOL ) . Our objective was to determine the responsiveness and minimal clinical ly important difference ( MCID ) of the EQ-5D health utility value ( EQ-5D HUV ) and visual analog scale ( EQ-5D VAS ) in chronic rhinosinusitis ( CRS ) . METHODS 203 adults undergoing medical management for CRS were prospect ively recruited . General health-related QOL ( using EQ-5D HUV and EQ-5D VAS ) and CRS-specific QOL ( using the 22-item Sinonasal Outcome Test [ SNOT-22 ] ) were measured at enrollment and a subsequent follow-up time point 2 - 12 months later . At follow-up , participants also rated change in general health as Much worse , A little worse , About the same , A little better or Much better compared to enrollment . The EQ-5D HUV and EQ-5D VAS MCIDs were calculated using distribution-based , anchor-based , and receiver operator characteristic ( ROC ) curve-based methods . RESULTS Change in SNOT-22 score was correlated with EQ-5D HUV and EQ-5D VAS change . Using the different methods of calculating MCID , we find the EQ-5D HUV MCID to be 0.04 and EQ-5D VAS MCID to be 8.0 . The calculated EQ-5D MCIDs had approximately a sensitivity of 40 - 50 % and specificity of 80 % in detecting patients experiencing noticeable improvement in general health . CONCLUSIONS The EQ-5D responds well to changing CRS symptomatology . We propose MCIDs for EQ-5D HUV of 0.04 and EQ-5D VAS of 8 in CRS patients , which although specific , are not sensitive for detecting patients experiencing improvement in general health
Changes in gait speed of 0.10 to 0.20 m s(-1 ) may be important across multiple patient groups
RATIONALE , AIMS AND OBJECTIVES Walking speed is an important performance variable , but information on the minimal clinical ly important difference ( MCID ) for the measure has not been consoli date d. In this review , we aim ed to summarize information on the MCID for change in comfortable gait speed measurements for patients with pathology .