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。
Outcome indicator was an essential part in a clinical study. Core Outcome Measures in Effectiveness Trials (COMET) initiative was presented by method experts in the field of international clinical research, and it expected to improve the value, comparability and transparency of clinical studies and provide more useful data for systematic reviews and Meta analysis, so as to make better use of the clinical studies and provide more valuable evidence for health decisions. This paper introduced the content of COMET and proposed the strategies to establish the core outcome set of Traditional Chinese Medicine.