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结局指标的确立是临床研究的关键内容之一。国际临床研究领域的方法学专家们提出了有效性试验核心结局测量指标(COMET)行动倡议,期望通过构建核心指标集来规范临床研究结局指标的选择、测量与报告,提高研究结果的实用性、可比性和透明度,进而为系统评价和Meta分析提供更多可用数据,使单个临床研究的价值得到更充分的利用,为健康相关决策提供更有价值的证据。本文着重介绍COMET行动的内容,并提出建立中医临床研究核心结局指标的策略。
The establishment of outcome indicators is one of the key aspects of clinical research. Methodology experts in the field of international clinical research put forward the COMET action initiative, and hope to build the core set of indicators to standardize the selection, measurement and reporting of outcome indicators of clinical research to improve the practicality of the findings, Comparability and transparency, which in turn provides more data available for systematic reviews and meta-analyzes, making the value of individual clinical studies more fully utilized and providing more valuable evidence for health-related decisions. This article focuses on the content of the COMET initiative and proposes strategies for establishing core outcomes of TCM clinical research.