Self-management interventions for adults living with Chronic Obstructive Pulmonary Disease (COPD): The development of a Core Outcome Set for COMPAR-EU project

Background: A large body of evidence suggests that self-management interventions (SMIs) may improve outcomes in chronic obstructive pulmonary disease (COPD). However, accurate comparisons of the relative effectiveness of SMIs are challenging, partly due to heterogeneity of outcomes across trials and uncertainty about the importance of these outcomes for patients. We aimed to develop a core set of patient-relevant outcomes (COS) for SMIs trials to enhance comparability of interventions and ensure person-centred care.

Methods: We undertook an innovative approach consisting of four interlinked stages: i) Development of an initial catalogue of outcomes from previous EU-funded projects and/or published studies, ii) Scoping review of reviews on patients and caregivers' perspectives to identify outcomes of interest, iii) Two-round Delphi online survey with patients and patient representatives to rate the importance of outcomes, and iv) Face-to-face consensus workshop with patients, patient representatives, health professionals and researchers to develop the COS.

Results: From an initial list of 79 potential outcomes, 16 were included in the COS plus one supplementary outcome relevant to all participants. These were related to patient and caregiver knowledge/competence, self-efficacy, patient activation, self-monitoring, adherence, smoking cessation, COPD symptoms, physical activity, sleep quality, caregiver quality of life, activities of daily living, coping with the disease, participation and decision-making, emergency room visits/admissions and cost effectiveness.

Conclusion: The development of the COPD COS for the evaluation of SMIs will increase consistency in the measurement and reporting of outcomes across trials. It will also contribute to more personalized health care and more informed health decisions in clinical practice as patients' preferences regarding COPD outcomes are more systematically included.

Contributors

Estela Camus-García 1, Ana Isabel González-González 1 2 3, Monique Heijmans 4, Ena Niño de Guzmán 5, Claudia Valli 6 7, Jessica Beltran 7, Hector Pardo-Hernández 8, Lyudmil Ninov 9, Valentina Strammiello 9, Kaisa Immonen 9, Dimitris Mavridis 10, Marta Ballester 1 3, Rosa Suñol 1 3, Carola Orrego 1 3

Publication

Journal: PLoS ONE
Volume: 16
Issue: 3
Pages: e0247522 -
Year: 2021
DOI: 10.1371/journal.pone.0247522

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This work was supported by the EU Horizon 2020 research and innovation programme (grant agreement no. 754936).


Health Area

Disease Category: Lungs & airways

Disease Name: Chronic obstructive pulmonary disease (COPD)

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Educational/self-management

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Literature review
- Systematic review