A Metasynthesis of Qualitative Literature to Inform the Selection of Meaningful and Measurable Health Concepts for Clinical Trials in COPD
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.384 | 0.516 |
| Meta-epidemiology (narrow) | 0.005 | 0.004 |
| Meta-epidemiology (broad) | 0.012 | 0.021 |
| Bibliometrics | 0.049 | 0.033 |
| Science and technology studies | 0.004 | 0.007 |
| Scholarly communication | 0.014 | 0.015 |
| Open science | 0.007 | 0.011 |
| Research integrity | 0.005 | 0.005 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".