GUIDE-COS: Consensus-informed guidance for incorporating lived experience perspectives in the long-list stage of Core Outcome Set development

BACKGROUND
Core Outcome Set (COS) development guidance emphasises the inclusion of people with lived experience (PWLE) 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. The GUIDE-COS project addresses this gap by creating consensus-informed, flexible methodological recommendations specifically designed to help COS developers, researchers, and PPI/PPIE partners meaningfully identify, collect, analyse, and report lived-experience perspectives in the long-list.

METHODS
This project uses a multi-interest-holder survey designed for respondents to rank guidance statements using a standard Likert-type agreement scale. Items meeting pre-determined consensus thresholds are adopted into the recommendations document. Statements meeting a pre-determined near-consensus threshold will under adjudication for inclusion via a project steering committee.

Candidate guidance statements were derived from a dual-evidence synthesis combining results from a scooping review (https://www.comet-initiative.org/Studies/Details/3590) and an in-depth qualitative interview study with COS developers and PWLE (https://comet-initiative.org/Studies/Details/3930). Following iterative refinement by the project steering committee, final survey statements were organised across four domains:
1. Design, Identification, Recruitment, and Engagement – for example, guidance on defining PWLE roles, recruitment processes, and ensuring meaningful engagement
2. Data Collection Considerations – for example, guidance on choosing appropriate methods to ensure PWLE perspectives are adequately captured
3. Analysis and Reporting – for example, guidance on preserving PWLE perspectives and reporting decisions transparently
4. Contextual Considerations – for example, guidance on ensuring Equity, Diversity, and Inclusion principles are addressed

ANTICIPATED IMPACT
We aim to deliver a consensus-informed “best practice” recommendations document that provide an adaptable framework for incorporating PWLE perspectives meaningfully and effectively in the long-list stage of the COS development process. The survey will ‘GO-LIVE” on 11 September 2026 and will remain open for 12 weeks.

Contributors

Marci Kay Livingston - PhD Student and Project Lead
Katie Robinson - Supervisor and Co-Lead
Elaine Toomey - Supervisor and Co-Lead
Patricia Logullo - Methods Expert
Sinead Purcell - PWLE and COS Developer
Prakalp Sudhakar - PWLE and PPI Partner
Kara McLoughlin - COS Developer
Eweling Lach - COS Developer

Further Study Information

Current Stage: Ongoing
Date: June 2026 - June 2027
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.


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Stakeholders Involved

Study Type

- COS methods research

Method(s)

- Survey