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Health status instruments for patients with COPD in pulmonary rehabilitation: defining a minimal clinically important difference.

ABSTRACT: The minimal clinically important difference (MCID) defines to what extent change on a health status instrument is clinically relevant, which aids scientists and physicians in measuring therapy effects. This is the first study that aimed to establish the MCID of the Clinical chronic obstructive pulmonary disease (COPD) Questionnaire (CCQ), the COPD Assessment Test (CAT) and the St George's Respiratory Questionnaire (SGRQ) in the same pulmonary rehabilitation population using multiple approaches. In total, 451 COPD patients participated in a 3-week Pulmonary Rehabilitation (PR) programme (58 years, 65% male, 43 pack-years, GOLD stage II/III/IV 50/39/11%). Techniques used to assess the MCID were anchor-based approaches, including patient-referencing, criterion-referencing and questionnaire-referencing, and the distribution-based methods standard error of measurement (SEM), 1.96SEM and half standard deviation (0.5s.d.). Patient- and criterion-referencing led to MCID estimates of 0.56 and 0.62 (CCQ); 3.12 and 2.96 (CAT); and 8.40 and 9.28 (SGRQ). Questionnaire-referencing suggested MCID ranges of 0.28-0.61 (CCQ), 1.46-3.08 (CAT) and 6.86-9.47 (SGRQ). The SEM, 1.96SEM and 0.5s.d. were 0.29, 0.56 and 0.46 (CCQ); 3.28, 6.43 and 2.80 (CAT); 5.20, 10.19 and 6.06 (SGRQ). Pooled estimates were 0.52 (CCQ), 3.29 (CAT) and 7.91 (SGRQ) for improvement. MCID estimates differed depending on the method used. Pooled estimates suggest clinically relevant improvements needing to exceed 0.40 on the CCQ, 3.00 on the CAT and 7.00 on the SGRQ for moderate to very severe COPD patients. The MCIDs of the CAT and SGRQ in the literature might be too low, leading to overestimation of treatment effects for patients with COPD.

SUBMITTER: Alma H

PROVIDER: S-EPMC5011855 | biostudies-other | 2016 Sep

REPOSITORIES: biostudies-other

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Health status instruments for patients with COPD in pulmonary rehabilitation: defining a minimal clinically important difference.

Alma Harma H de Jong Corina C Jelusic Danijel D Wittmann Michael M Schuler Michael M Flokstra-de Blok Bertine B Kocks Janwillem J Schultz Konrad K van der Molen Thys T

NPJ primary care respiratory medicine 20160901

The minimal clinically important difference (MCID) defines to what extent change on a health status instrument is clinically relevant, which aids scientists and physicians in measuring therapy effects. This is the first study that aimed to establish the MCID of the Clinical chronic obstructive pulmonary disease (COPD) Questionnaire (CCQ), the COPD Assessment Test (CAT) and the St George's Respiratory Questionnaire (SGRQ) in the same pulmonary rehabilitation population using multiple approaches. ...[more]

PMID: 27597571

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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:The Minimal Clinically Important Difference (MCID) assesses what change on a measurement tool can be considered minimal clinically relevant. Although the recall period can influence questionnaire scores, it is unclear if it influences the MCID. This study is the first to examine longitudinally the impact of the recall period of an anchor question and its design on the MCID of COPD health status tools using the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and the St. George's Respiratory Questionnaire (SGRQ).Moderate to very severe COPD patients without respiratory co-morbidities were recruited during 3-week Pulmonary Rehabilitation (PR). CAT, CCQ and SGRQ were completed at baseline, discharge, 3, 6, 9 and 12 months. A 15-point Global Rating of Change scale (GRC) was completed at each follow-up. A five-point GRC was used as second anchor at 12 months. Mean change scores of a subset of patients indicating a minimal improvement on each of the anchor questions were considered the MCID. The MCID estimates over different time periods were compared with one another by evaluating the degree of overlap of Confidence Intervals (CI) adjusted for dependency.In total 451 patients were included (57.9?±?6.6 years, 65% male, 50/39/11% GOLD II/III/IV), of which 309 completed follow-up. Baseline health status scores were 20.2?±?7.3 (CAT), 2.9?±?1.2 (CCQ) and 50.7?±?17.3 (SGRQ). MCID estimates for improvement ranged -?3.1 to -?1.4 for CAT, -?0.6 to -?0.3 for CCQ, and?-?10.3 to -?7.6 for SGRQ. Absolute higher - though not significant - MCIDs were observed for CAT and CCQ directly after PR. Significantly absolute lower MCID estimates were observed for CAT (difference?-?1.4: CI -2.3 to -?0.5) and CCQ (difference?-?0.2: CI -0.3 to -0.1) using a five-point GRC.The recall period of a 15-point anchor question seemed to have limited impact on the MCID for improvement of CAT, CCQ and SGRQ during PR; although a 3-week MCID estimate directly after PR might lead to absolute higher values. However, the design of the anchor question was likely to influence the MCID of CAT and CCQ.RIMTCORE trial # DRKS00004609 and #12107 (Ethik-Kommission der Bayerischen Landesärztekammer).

Project description:BACKGROUND:Idiopathic pulmonary fibrosis (IPF) specific version of St. George's Respiratory Questionnaire (SGRQ-I) and King's Brief Interstitial Lung Disease questionnaire (K-BILD) are validated health-related quality of life (HRQL) instruments, but no or limited data exist on their responsiveness and minimal clinically important difference (MCID). The objectives of this study were to assess responsiveness of SGRQ-I and K-BILD and determine MCID separately for deterioration and improvement in a large, prospective cohort of patients with IPF in a real-world setting. METHODS:Consecutive patients with IPF were recruited. SGRQ-I, K-BILD, SGRQ, Shortness of Breath Questionnaire, pulmonary function tests and 6-min walk test measurements were obtained at baseline and at six and 12?months; at six and 12?months, patients also completed Global Rating of Change Scales. Responsiveness was assessed using correlation coefficients and linear regression. Cox regression was used for mortality analyses. MCID was estimated using receiver operating characteristic curves with separate analyses for improvement and deterioration. RESULTS:A total of 150 IPF patients were included and 124 completed the 12-month follow-up. Based on all HRQL anchors and most physiological anchors, responsiveness analyses supported the evidence pointing towards SGRQ-I and K-BILD as responsive instruments. Multivariate analyses showed an association between SGRQ-I and mortality (HR: 1.18, 95% CI: 1.02 to 1.36, p?=?0.03) and a trend was found for K-BILD (HR: 0.82, 95% CI: 0.64 to 1.05, p?=?0.12). MCID was estimated for all domains of SGRQ-I and K-BILD. MCID for improvement differed from deterioration for both SGRQ-I Total (3.9 and 4.9) and K-BILD Total (4.7 and 2.7). CONCLUSIONS:SGRQ-I and K-BILD were responsive to change concerning both HRQL and most physiological anchors. MCID was determined separately for improvement and deterioration, resulting in different estimates; especially a smaller estimate for deterioration compared to improvement in K-BILD. TRIAL REGISTRATION:Clinicaltrials.gov, no. NCT02818712. Registered 30 June 2016.

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Health status instruments for patients with COPD in pulmonary rehabilitation: defining a minimal clinically important difference.

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Health status instruments for patients with COPD in pulmonary rehabilitation: defining a minimal clinically important difference.

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