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试验必须报告的、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，需要经过不同利益群体的高级代表一致性认定、达成共识。共识方法设计的科学性和实施的透明化，决定了最终形成的核心指标集的质量。因此，在中医药核心指标集（Core Outcome Set for Traditional Chinese Medicine，COS-TCM）研制过程中共识过程的设计和实施至关重要。本文对COS-TCM研制中共识方法的实施要点进行归纳总结，以期为中医药核心指标集研究的开展提供方法学借鉴。

The core outcome set is a collection of uniform, standardized minimum 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 requires a consistent determination and consensus among senior delegates from different interest groups. The quality of the final core outcome set is determined by the transparency and traceability of the design and implementation of the consensus approach. Therefore, the design and implementation of the consensus process in the development of the core outcome set for traditional Chinese medicine (COS-TCM) is crucial. In this paper, we summarizes the implementation points of the consensus method in the development of COS-TCM, in order to provide methodological references for the development of other core outcome set of traditional Chinese medicine.

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。