Use, knowledge, & attitudes on core outcome sets among trialists & systematic reviewers in India: A survey.

Background & objectives Core Outcome Sets (COS) are consensus-derived standardized outcomes that improve the transparency, consistency, homogeneity, and usefulness of outcomes. While COS are being increasingly developed, not much is known about their awareness, use, knowledge, and attitudes among trialists and systematic reviewers. This study aimed to examine the use, knowledge, and attitudes about COS among clinical trialists and systematic reviewers in India. Methods We conducted an anonymous online survey between August 2023 to November 2023, using a questionnaire hosted on REDCap including trialists and/or systematic reviewers as participants. The survey tool evaluated awareness, use and attitudes on COS, including through a couple of open-ended questions. Results A total of 523 trialists/ systematic reviewers participated in this survey. Of these, only 51.4 per cent indicated that they were aware of COS. Only 13.9 per cent trialists and 10.5 per cent systematic reviewers were using them, while mere 6 per cent had been involved in COS development. Lack of available COS for conditions of interest in an Indian context was identified as one of the barriers in its uptake. Even among participants who were aware, many were not clear about COS concepts, and although they expressed positive attitudes about the benefits of COS usage, they also indicated that they perceived COS as restrictive, costly, blocking innovation, and increasing patient burden. We identified health conditions relevant to India, where there is no COS available or where COS is present but were mentioned to be not relevant or valid for the Indian context. Interpretation & conclusions As per our knowledge, this study is the largest survey on this domain globally. Through this study several barriers for enhancing COS awareness and uptake were identified indicating the need for resources and systematic efforts to address these barriers in India and globally. We also identify COS which need to be developed or updated to be relevant to Indian context.