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
Eighteen people took part in interviews across three groups: COS developers (n=10), PWLE of the condition targeted by the COS (n=4), and a group who hold both roles (n=4). Three main findings came out of the analysis.
(1) The conditions for inclusion: Meaningful inclusion of lived experience perspectives in the long-list process depended on a combination of practical conditions (time, funding, institutional support), relational conditions (trust, power dynamics, peer relationships), and whose knowledge was valued and centred in the process. Developers tended to focus on the practical and knowledge-related side of this, while participants with lived experience spoke most about the relational side, including whether they felt genuinely welcomed and listened to rather than included as a formality.
(2) The labour of inclusion: Bringing lived experience into the long-list stage involved considerably more work than existing guidance accounts for. This included finding effective ways to draw out what mattered most to people (often through open conversation rather than directly asking "what should be measured"), translating what people shared into usable outcome language, and then condensing the long list of outcomes down to something workable, a step several developers described as one of the most demanding parts of the whole process.
(3) Navigating guidance gaps: Developers described relying on existing resources such as the COMET Handbook, OMERACT guidance, and the Dodd Taxonomy as a useful starting point for long-list development, but often not detailed enough for the specific population or condition they were working with. This meant relying on professional judgement, published examples from other studies, and informal advice from more experienced colleagues to fill the gaps. Interestingly, most developers did not want fully prescriptive guidance either, valuing the flexibility to adapt their approach to their own project's needs.
Across all three groups, one point came through clearly: including lived experience perspectives in the long-list often added outcomes and/or identified priorities that would otherwise have been missed entirely from trial literature and clinician input, and in some cases directly shaped the final outcome set.
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
Disease Category:
Disease Name:
Age Range: Unknown
Sex:
Nature of Intervention:
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Researchers
- Service providers
- Service users
- COS methods research
- Interview
Qualitative interview study with 18 participants - Analysis guided by framework analysis.