Inclusion of participants from low-income and middle-income countries in core outcome sets development: a systematic review.

OBJECTIVE: Our study aims to describe differences or similarities in the scope, participant characteristics and methods used in core outcome sets (COS) development when only participants from high-income countries (HICs) were involved compared with when participants from low-income and middle-income countries (LMICs) were also involved. DESIGN: Systematic review. DATA SOURCES: Annual Core Outcome Measures in Effectiveness Trials systematic reviews of COS which are updated based on SCOPUS and MEDLINE, searches. The latest systematic review included studies published up to the end of 2019. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included studies reporting development of a COS for use in research regardless of age, health condition or setting. Studies reporting the development of a COS for patient-reported outcomes or adverse events or complications were also included. DATA EXTRACTION AND SYNTHESIS: Data were extracted in relation to scope of the COS study, participant categories and the methods used in outcome selection. RESULTS: Studies describing 370 COS were identified in the database. Of these, 75 (20%) included participants from LMICs. Only four COS were initiated from an LMIC setting. More than half of COS with LMIC participants were developed in the last 5 years. Cancer and rheumatology were the dominant disease domains. Overall, over 259 (70%) of COS explicitly reported including clinical experts; this was higher where LMIC participants were also included 340 (92%). Most LMIC participants were from China, Brazil and South Africa. Mixed methods for consensus building were used across the two settings. CONCLUSION: Progress has been made in including LMIC participants in the development of COS, however, there is a need to explore how to enable initiation of COS development from a range of LMIC settings, how to ensure prioritisation of COS that better reflects the burden of disease in these contexts and how to improve public participation from LMICs.