核心指标集是通过一系列规范的研制过程，形成某种疾病所有相关临床研究必须报告的、统一的、标准化的最小指标集合。确定哪些指标为核心结局指标，需要经过不同利益相关群体层层筛选并最终达成共识决定。相关利益群体的代表性，决定了核心指标集的系统性和合理性。因此，在核心指标集研制过程中利益相关群体的选择至关重要。本文对中医药核心指标集研制中利益相关群体的种类选择、样本量、参与环节、权重分配以及患者代表群的特殊性等相关要点进行归纳总结，以期为中医药核心指标集研究的开展提供方法学借鉴。

A core outcome set is the minimum set of uniform, standardized indicators that must be reported in all relevant clinical trials for a given disease through a series of standardized development processes. Determining which indicators are core outcome indicators requires a multi-level screening and final consensus decision by different stakeholder groups. The representativeness of the relevant stakeholder groups determines the representativeness of the core outcome set. Therefore, the selection of interest groups in the development of the core indicator set of Chinese medicine (COS-TCM) is crucial. In this paper, we summarize the key points related to the selection of stakeholder groups, sample size, participation, weight distribution, and the specificity of patient representative groups in the development of COS-TCM, in order to provide methodological guidance for the development of other COS-TCM.

R2-031

国家自然科学基金委员会资助项目（81473544）：中医药临床试验核心指标集(COS-TCM）构建方法研究，负责人：张俊华；国家自然科学基 金委员会资助项目（81904056）：中医药临床试验核心指标（COS）测评方法学研究，负责人：张明妍。