Introduction: There is high heterogeneity of outcomes and measures reported in pulmonary rehabilitation (PR) trials of people with chronic obstructive pulmonary disease (COPD). This hinders study comparability and benchmarking of PR. We have developed a core outcome set (COS) to overcome these challenges.
Methods: This study was informed by a systematic review and two qualitative studies and had patient involvement since its inception. A two-round Delphi survey was available in seven languages. Outcomes (n=63) scored 7-9 (crucial) by =70% of the participants and 1-3 (not that important) by =15% of participants from both groups in the Likert scale were automatically included in the COS, while outcomes that were considered crucial by only one of the groups were further discussed by the authors in a meeting.
Results: A total of 299 people (n=229 healthcare professionals/researchers/policy-makers; n=70 people with COPD and informal caregivers) participated in the survey (83% retention), which covered 29 countries/five continents. After the second round, six outcomes were included and three were added in the meeting. The final COS contains dyspnoea, fatigue, functional exercise capacity, health-related quality of life, health behaviours/lifestyle, knowledge about the disease, lower limb muscle function, personal goals and problematic activities of daily living.
Conclusion: A COS for PR of people with COPD is now available and can be used by different stakeholders to improve consistency and comparability of studies, benchmark PR and improve the quality of care provided. Future research should establish the core measures and investigate the uptake of this COS.
Principal investigator/supervisor: Alda Marques
Collaborators: Sara Miranda Lab3R – Respiratory Rehabilitation and Research Laboratory, School of Health Sciences, University of Aveiro, Aveiro, Portugal Institute for Research in Biomedicine (iBiMED), University of Aveiro, Aveiro, Portugal
Co-supervisor: Professor Martijn Spruit - REVAL Rehabilitation Research Center, BIOMED Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, Belgium
- Department of Research and Development, CIRO, Horn, The Netherlands
- Department of Respiratory Medicine, Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands
- NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands
Disease Category: Lungs & airways, Rehabilitation
Disease Name: Chronic obstructive pulmonary disease (COPD)
Age Range: 40 - 90
Sex: Either
Nature of Intervention: Pulmonary rehabilitation
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- Policy makers
- Regulatory agency representatives
- COS for practice
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Interview
- Systematic review
This COS will be accomplished through i) a systematic review of the literature, ii) patients, caregivers, health professionals, policy makers focus groups, iii) delphi study and iv) consensus meeting.