Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Fatigue in Patients With COPD Following Pulmonary Rehabilitation.

Chest

Lab3R-Respiratory Research and Rehabilitation Laboratory, School of Health Sciences, University of Aveiro, Aveiro, Portugal; iBiMED-Institute of Biomedicine, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal. Electronic address:

Published: August 2020

Background: Fatigue is a burdensome and prevailing symptom in patients with COPD. Pulmonary rehabilitation (PR) improves fatigue; however, interpreting when such improvement is clinically relevant is challenging. Minimal clinically important differences (MCIDs) for instruments assessing fatigue are warranted to better tailor PR and guide clinical decisions.

Research Question: This study estimated MCIDs for the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-FS), the modified FACIT-FS, and the Checklist Individual Strength-Fatigue Subscale in patients with COPD following PR.

Study Design And Methods: Data from patients with COPD who completed a 12-week community-based PR program were used to compute the MCIDs. The pooled MCID was estimated by calculating the arithmetic weighted mean, resulting from the combination of anchor-based (weight, two-thirds) and distribution-based (weight, one-third) methods. Anchors were patients' and physiotherapists' Global Rating of Change Scale, COPD Assessment Test, St. George's Respiratory Questionnaire (SGRQ), and exacerbations. To estimate MCIDs, we used mean change, receiver-operating characteristic curves, and linear regression analysis for anchor-based approaches, and 0.5 × SD, SE of measurement, 1.96 × SE of measurement, and minimal detectable change for distribution-based approaches.

Results: Fifty-three patients with COPD (79% male, 68.4 ± 7.6 years of age, and FEV 48.7 ± 17.4% predicted) were included in the analysis. Exacerbations and the SGRQ-impact and the SGRQ-total scores fulfilled the requirements to be used as anchors. Pooled MCIDs were 4.7 for FACIT-FS, 3.8 for the modified FACIT-FS, and 9.3 for the Checklist Individual Strength-Fatigue Subscale.

Intrpretation: The MCIDs proposed in this study can be used by different stakeholders to interpret PR effectiveness.

Clinical Trial Registration: ClinicalTrials.gov; No.: NCT03799666; URL: www.clinicaltrials.gov.

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Source
http://dx.doi.org/10.1016/j.chest.2020.02.045DOI Listing

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