BMJ open · 2026
Development of a framework to improve the quality and value of choosing outcomes in cardiovascular disease research (FAVOUR): a study protocol.
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Qiu Ruijin, Wang Shuangqiu, Yu Changhe, Zhao Chen, Guan Zhiyue, Li Siyi, Shi Lulu, Jin Ying-Hui, Li Min, Liu Shuling, Chai Shiguang, Chen Hong, Chen Zhuo, Shang Hongcai
Аннотация
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).
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).