Methodological guidance for incorporating lived experience in the early stages of core outcome set development: a scoping review protocol

Introduction: One challenge facing researchers is the heterogeneity of outcomes measured in health research. Researchers can reduce outcome heterogeneity and ensure relevance of outcomes by using a Core Outcome Set (COS). COS are agreed-upon minimum sets of outcomes that should be measured in all clinical trials within a specific health area or healthcare domain. The Core Outcome Measures in Effectiveness Trials (COMET) Initiative produced the COMET Handbook, which consolidated COS methodological literature and outlines a multistage approach to COS development. This approach includes generating a long-list of all potential outcomes and later reducing that list to essential outcomes via a consensus process. COMET emphasizes that COS should include outcomes that are important to all stakeholders, including those with lived experience; however, it does not provide ample guidance on how to achieve this in the early, long-list phase. The objectives of this scoping review are to systematically map the available methodological literature on how to incorporate the perspectives of those with lived experience into the long-list generation stage of COS development. Methods and analysis: This review will follow the Joanna Briggs Institute (JBI) guidance for scoping reviews and will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews (PRISMA-ScR) checklist. The databases searched will be Embase, Scopus, MEDLINE (EBSCO), CINAHL (EBSCO), the COMET Database, and ProQuest Theses and Dissertations. Reference lists of the articles found via database searches that meet the inclusion criteria will be hand searched. Expert consultation will be used to identify any relevant articles not found via database or hand searching. Two researchers will independently screen and extract data, summarizing results narratively. Implications: This review will address gaps in understanding regarding the inclusion of the perspectives of individuals with lived experience in the early stages of COS development.