COMET Initiative | Incorporating the perspectives of people with lived experience in the long-list stage of Core Outcome Set development: A qualitative framework analysis of interest-holder experiences

Incorporating the perspectives of people with lived experience in the long-list stage of Core Outcome Set development: A qualitative framework analysis of interest-holder experiences

BACKGROUND
Core Outcome Set (COS) development guidance emphasises the inclusion of people with lived experience throughout the development process, yet prevailing guidance predominately focuses on the consensus stages of COS development, with limited guidance currently available on earlier stages such as when the long-list of outcomes is identified. This long-list stage is critical, as it shapes the outcomes eventually brought to later consensus stages. There is limited empirical evidence on the methodological choices made by COS developers when seeking to include the perspectives of people with lived experience (PWLE) into the long-list stage of COS development. This study sought to explore the experience of COS developers and PWLE previously involved in a COS development project, with particular attention to decision-making and implementation.

METHODS
A qualitative study using semi-structured interviews was conducted with COS developers and PWLE previously involved in a COS development process. Interviews were audio-recorded, transcribed verbatim, and analysed using framework analysis. Line-by-line inductive coding was undertaken of individual transcripts, followed by the development of an analytical framework, then matrix-based analysis across participants in each cohort, and a final cross-cohort analysis.

RESULTS
A total of 18 participants were interviewed between Aug 2025 and Feb 2026. Analysis is ongoing. Initial findings highlight that across all participants, a commitment to PWLE inclusion was consistently described; however, methods chosen to implement this inclusion varied substantially.

Contributors

PI: Marci Kay Livingston DNP, MPH, RN, CHPN
1:Health Research Board – Trials Methodology Research Network, University of Limerick, Limerick, Ireland
2:School of Allied Health, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland
3:Health Research Institute, University of Limerick, Limerick, Ireland

Supervisors
Katie Robinson PhD, MSc, BSc
1:Health Research Board – Trials Methodology Research Network, University of Limerick, Limerick, Ireland
2:School of Allied Health, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland
3:Health Research Institute, University of Limerick, Limerick, Ireland
4:Ageing Research Centre, University of Limerick, Limerick, Ireland

Elaine Toomey PhD, MSc, BSc, MISCP
1:Centre for Health Research Methodology, School of Nursing and Midwifery, University of Galway, Galway, Ireland
2:Institute for Clinical Trails, College of Medicine, Nursing, and Health Sciences, University of Galway, Galway, Ireland

Further Study Information

Current Stage: Ongoing
Date: August 2025 - August 2026
Funding source(s): This research forms part of a doctoral research project supported by the Health Research Board Trials Methodology Research Network (HRB-TMRN) PhD scholarship awarded to MKL. The funder had no role in the design, data collection, and analysis or preparation of the project.

Health Area

Disease Category:

Disease Name:

Target Population

Age Range: Unknown

Sex:

Nature of Intervention:

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Researchers
- Service providers
- Service users

Study Type

- COS methods research

Method(s)

- Interview

Qualitative interview study with 18 participants - Analysis guided by framework analysis.

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