Background
Core Outcome Sets (COS) provide a systematic approach to ensuring outcomes measured in health research matter to the individuals most affected by the research. While methodological guidance exists for COS development generally, specific guidance on incorporating the perspectives of people with lived experience (PWLE) during the long-list stage remains fragmented and unclear. This stage of COS development is key to ensuring that outcomes taken to later, consensus-based stages, include those that are most important to those directly impacted by health research. Therefore, the objective of this scoping review was to systematically map the available methodological literature on how to incorporate the perspectives of PWLE into the long-list generation stage of COS development.
Methods
As preparation for this review, we searched for existing published handbooks and/or guidelines for COS development, with the most accessible being the COMET Handbook V1.0 (Williamson et.al. 2017) and the OMERACT Handbook V2.0 (Beaton et.al. 2021).
This review followed JBI guidance for scoping reviews and adhered to PRISMA-ScR reporting standards. A comprehensive search was conducted across multiple databases (MEDLINE, Embase, Scopus, CINHAL, ProQuest Theses & Dissertations, and the COMET Database) on 31 OCT 2024. In addition, a citation search of all included articles and further expert consultation was included to ensure all relevant articles were identified. Articles were eligible for inclusion if they provided methodological guidance, recommendations and/or insight into how best to include the perspectives of PWLE into the long-list stage of COS development. Screening and data extraction was completed by two independent reviewers. Analysis was guided by a combined deductive-inductive qualitative content analysis process. Themes were developed from the data, and were synthesised into practical recommendations for COS developers.
Results
A total of 45 articles were included. Analysis yielded four major thematic areas of guidance: (1) PWLE Identification, Recruitment, Retention, and Integration Considerations; (2) Data Collection Considerations; (3) Analysis, Validation, and Reporting Considerations; and (4) Contextual Considerations. The results highlight an evolving methodological landscape surrounding PWLE perspective integration into COS development. Results emphasise the importance of purposeful and reflexive methodological choices, and underscore the importance of utilizing existing qualitative research, participatory action research, reporting standards, and existing EDI principles throughout the long list process.
Implications and Relevance
This review identified a growing but uncoordinated body of methodological guidance for including the perspectives of PWLE into the long list stage of COS development. Findings will support future COS developers in making methodologically rigorous decisions. Future research should aim to validate these findings and recommendations through empirical work with COS developers and PWLE, informing the co-production of best practice guidelines.
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: Methodological & diagnostic
Disease Name: N/A
Age Range: Unknown
Sex:
Nature of Intervention: N/A
- Consumers (patients)
- Methodologists
- COS methods research
- Literature review
Scoping review following JBI guidelines