Baseline dependent minimally important differences for clinical outcomes of pulmonary rehabilitation in people with COPD

A R Jenkins; M T J Groenen; A W Vaes; D J A Janssen; E F M Wouters; F M E Franssen; M A Spruit

doi:10.1016/j.pulmoe.2023.06.004

Baseline dependent minimally important differences for clinical outcomes of pulmonary rehabilitation in people with COPD

Pulmonology. 2024 Jan-Feb;30(1):24-33. doi: 10.1016/j.pulmoe.2023.06.004. Epub 2023 Jul 16.

Authors

A R Jenkins¹, M T J Groenen², A W Vaes², D J A Janssen³, E F M Wouters⁴, F M E Franssen⁴, M A Spruit⁴

Affiliations

¹ Clinical Exercise and Respiratory Physiology Laboratory, Dept of Kinesiology and Physical Education, Faculty of Education, McGill University, Montreal, QC, Canada. Electronic address: alex.jenkins@mcgill.ca.
² Department of Research and Development, Ciro, Horn, the Netherlands.
³ Department of Research and Development, Ciro, Horn, the Netherlands; Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.
⁴ Department of Research and Development, Ciro, Horn, the Netherlands; Department of Respiratory Medicine, Maastricht University Medical Centre, NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.

PMID: 37455240
DOI: 10.1016/j.pulmoe.2023.06.004

Abstract

Introduction: Minimally important differences (MIDs) for common outcomes of pulmonary rehabilitation are well documented for people with chronic obstructive pulmonary disease (COPD). It is not known whether MIDs differ based on COPD disease characteristics. This study aimed to estimate MIDs for clinical outcomes of pulmonary rehabilitation dependent upon baseline characteristics.

Methods: A database containing 2791 people with COPD was split into derivation (n=2245; age 66±9 years; 50% males; FEV₁ 47±20% predicted) and comparator (n=546; age 66±9 years; 47% males; FEV₁ 46±21% predicted) cohorts. MIDs were estimated using 0.5 x SD (symmetrically distributed) or 0.5 x IQR (non-symmetrically distributed) for: 6-minute walk test (6MWT), constant work rate test (CWRT), COPD assessment test (CAT), St. George's respiratory questionnaire (SGRQ), hospital anxiety and depression scale (HADS), and fat-free mass index (FFMI). MIDs were estimated based on baseline outcome scores, lung function, modified medical research council (mMRC) grade and FFMI.

Results: MID estimates were comparable to previously reported values. MIDs for SGRQ domains (Symptom=8.7 points, Activity=7.1 points, Impact=8.1 points) and FFMI were produced (0.36kg/m²). There was greater variation of change in 6MWT, SGRQ-activity, SGRQ-impact, HADS and FFMI on which the MIDs were determined when categorising for baseline values (all, p<0.05). Greater variation of change in 6MWT on which the MIDs were determined was evident with COPD disease severity grouping (p<0.05). The magnitude of change in 6MWT, CAT, CWRT, SGRQ-activity, and FFMI with baseline mMRC score categorisation resulted in greater variation on which the MIDs were determined (all, p<0.05). Baseline stratification for FFMI resulted in greater variation of change in CWRT (p<0.001) and HADS-depression (p = 0.043) on which MIDs were determined.

Discussion: Findings suggest that baseline presentation should be considered for people with COPD when assessing the efficacy of pulmonary rehabilitation. However, clinical significance of the variation underpinning MIDs is yet to be determined.

Keywords: Clinical outcomes; Minimally important differences; Pulmonary rehabilitation.

MeSH terms

Aged
Female
Humans
Male
Middle Aged
Pulmonary Disease, Chronic Obstructive*
Respiratory Function Tests
Surveys and Questionnaires
Walk Test