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The minimal important difference of exercise tests in severe COPD.

ABSTRACT: Our aim was to determine the minimal important difference (MID) for 6-min walk distance (6MWD) and maximal cycle exercise capacity (MCEC) in patients with severe chronic obstructive pulmonary disease (COPD). 1,218 patients enrolled in the National Emphysema Treatment Trial completed exercise tests before and after 4-6 weeks of pre-trial rehabilitation, and 6 months after randomisation to surgery or medical care. The St George's Respiratory Questionnaire (domain and total scores) and University of California San Diego Shortness of Breath Questionnaire (total score) served as anchors for anchor-based MID estimates. In order to calculate distribution-based estimates, we used the standard error of measurement, Cohen's effect size and the empirical rule effect size. Anchor-based estimates for the 6MWD were 18.9 m (95% CI 18.1-20.1 m), 24.2 m (95% CI 23.4-25.4 m), 24.6 m (95% CI 23.4-25.7 m) and 26.4 m (95% CI 25.4-27.4 m), which were similar to distribution-based MID estimates of 25.7, 26.8 and 30.6 m. For MCEC, anchor-based estimates for the MID were 2.2 W (95% CI 2.0-2.4 W), 3.2 W (95% CI 3.0-3.4 W), 3.2 W (95% CI 3.0-3.4 W) and 3.3 W (95% CI 3.0-3.5 W), while distribution-based estimates were 5.3 and 5.5 W. We suggest a MID of 26 ± 2 m for 6MWD and 4 ± 1 W for MCEC for patients with severe COPD.

SUBMITTER: Puhan MA

PROVIDER: S-EPMC5516638 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature

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The minimal important difference of exercise tests in severe COPD.

Puhan M A MA Chandra D D Mosenifar Z Z Ries A A Make B B Hansel N N NN Wise R A RA Sciurba F F

The European respiratory journal 20100806 4

Our aim was to determine the minimal important difference (MID) for 6-min walk distance (6MWD) and maximal cycle exercise capacity (MCEC) in patients with severe chronic obstructive pulmonary disease (COPD). 1,218 patients enrolled in the National Emphysema Treatment Trial completed exercise tests before and after 4-6 weeks of pre-trial rehabilitation, and 6 months after randomisation to surgery or medical care. The St George's Respiratory Questionnaire (domain and total scores) and University o ...[more]

PMID: 20693247

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Project description:Background and objectivesField exercise tests (eg, 6-minute walk test [6MWT]) are important measures of functional exercise capacity in people with COPD. Shorter tests such as the 2-minute walk test (2MWT) may offer advantages in some populations but lack information about responsiveness to change. This study examined responsiveness, minimal important difference (MID), test-retest reliability, and construct validity of the 2MWT in people with stable COPD attending outpatient pulmonary rehabilitation (PR).MethodsAt pre-PR assessment, study participants completed a 2MWT twice in addition to usual measures (6MWT and Chronic Respiratory Questionnaire). At post-PR assessment following a standard PR program, measures were repeated and global rating of change scores obtained (patient and therapist). Pre-post program change scores were examined for correlations with change in 2-minute walk distance (2MWD) and used (where r≥0.3) to estimate the MID through anchor-based methods. Distribution-based estimates based on standard error of measurement were examined. Test-retest reliability (intraclass correlation coefficient [ICC] and Bland-Altman agreement) and validity (Pearson correlation with 6-minute walk distance [6MWD]) were reported.ResultsFifty-nine people (28 men) with stable COPD, mean age 68 years (SD 10 years), and percentage predicted forced expiratory volume in 1 second 48% (SD 20%) attended pre-PR assessment. Test-retest ICC for same-session 2MWD was 0.985. A mean difference of 2.4 m (95% confidence interval [CI] 0.7-4.0 m, P=0.006) occurred between the first and second trials. 2MWD and 6MWD were highly correlated (r=0.87, P<0.001). Forty-one participants completed PR and were included in responsiveness and MID analysis. Mean 2MWD improved significantly post-PR (8.8 m, 95% CI 3.6-14 m, P=0.001). The MID in 2MWD, anchored against clinically meaningful change in 6MWD, was 5.5 m (area under curve =0.81, P=0.001). Distribution-based methods estimated an MID of 4 m.ConclusionChange in 2MWD of at least 5.5 m following a PR program corresponded to a clinically meaningful change. A practice test is recommended due to learning effects.

Project description:BackgroundA minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double-blind, placebo-controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1-7).ObjectivesTo estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor-based method.MethodsData were pooled from three 6-week double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: "low dose," which includes 40 or 50 mg/day; and "high dose," which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine- and placebo-treated) with a Clinical Global Impression of Change-Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved).ResultsThe least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: -2.4; high dose: -3.2; both, P < 0.001) versus placebo (-0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change-Tardive Dyskinesia score ≤3 at week 6 (mean change: -2.2; median change: -2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: -2.0; median change: -2).ConclusionsResults from an anchor-based method indicate that a 2-point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

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The minimal important difference of exercise tests in severe COPD.

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The minimal important difference of exercise tests in severe COPD.

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