A Metasynthesis of Qualitative Literature to Inform the Selection of Meaningful and Measurable Health Concepts for Clinical Trials in COPD.

Abstract

Objectives: A critical step in designing clinical trials to evaluate treatment efficacy in chronic obstructive pulmonary disease (COPD) is selecting fit-for-purpose outcome measures that reflect health concepts meaningful to people living with COPD. The purpose of this review was to summarize and synthesize qualitative literature addressing how patients with COPD describe aspects of their disease, to inform health concept selection and outcome measure selection.

Methods: A literature review and metasynthesis of qualitative research published from 2013 to 2023 was performed. Studies meeting criteria underwent critical appraisal and data extraction. Studies were summarized and synthesized with constant comparative analysis to review author interpretations and direct patient quotes.

Results: Nineteen studies addressing the patient experience of COPD met screening criteria for full review and data synthesis. In total, 507 patients (range: 8-64 individuals per study) across 11 countries participated in these studies via interviews (63.2%), focus groups (15.8%), or online forums (5.3%). Prominent COPD symptoms included breathlessness, cough, mucus, wheezing, chest discomfort, difficulty sleeping, tiredness, and weakness. Patients described significant impacts on physical activity, emphasizing difficulties with activities of daily living. The symptoms experienced and the persistent limitation on physical activity had severe consequences on social and role functioning and psychological and emotional health.

Conclusion: This qualitative metasynthesis summarizes evidence about symptoms experienced by patients with COPD and the impact of these symptoms on daily life. The synthesis provides an empirical foundation for the development of a standardized set of patient-inspired health concepts to be considered when selecting outcome measures for COPD clinical trials.