Development of a framework to improve the quality and value of choosing outcomes in cardiovascular disease research (FAVOUR): a study protocol

Abstract

Abstract Background Selecting appropriate outcomes is crucial for enhancing the comparability and relevance of clinical trials, yet uptake of core outcome sets (COS) remains low. This study aims to develop a framework to improve the quality and value of choosing outcomes in cardiovascular disease research (FAVOUR), so that the uptake of COS may be improved. Methods The mixed-methods will be used to develop a framework: (1) a systematic review will be conducted to identify current rationales, values and preferences of different stakeholders of outcome selection in clinical trials; (2) semi-structured interviews with patients and healthcare professionals will be used to identify the evidence, values and preferences of different stakeholders in outcome selection and measurement; (3) two rounds of Delphi survey will be conducted to prioritise items for the framework; and (4) a consensus meeting will be carried out to finalise the framework. Ethics and dissemination This study has been approved by the ethics committee of Dongzhimen Hospital, Beijing University of Chinese Medicine (Approval No.: 2025DZMEC-148-02). The results will be disseminated through peer-reviewed journals and conference presentations. Trial registration number This research has been registered in the Core Outcome Measures in Effectiveness Trial database (https://www.comet-initiative.org/Studies/Details/3723).