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
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
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 .