Key result
Protocol outlines development of a core safety outcome set for integrated traditional and Western cardiovascular trials.
Why the study?
Clinical trialists frequently prioritize reporting efficacy over safety outcomes, leaving safety evidence unclear and creating a need for a core outcome set for cardiovascular safety in integrated medicine.
This protocol outlines the methodology for developing a core outcome set to standardize the reporting of safety outcomes in clinical trials of integrated traditional Chinese and Western medicine for cardiovascular diseases.
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May improve safety data consistency in integrated TCM-Western CVD trials; leaves open validation before clinical adoption.
Qiu et al. (2022) studied Cardiovascular diseases (angina pectoris, myocardial infarction, heart failure, arrhythmia, and hypertension). Integrated traditional Chinese medicine and Western medicine was evaluated on Core outcome set (COS) for assessing clinical safety outcomes. This study protocol outlines the methodology for developing a core outcome set to assess clinical safety outcomes in trials of integrated traditional Chinese and Western medicine for cardiovascular diseases.
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