2020年 第6卷 第10期
《工程（英文）》 >> 2020年 第6卷 第10期 doi: 10.1016/j.eng.2020.03.002
新冠病毒肺炎临床试验核心指标集（COS-COVID）
a Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
b Chinese Core Outcome Sets Research Center, Tianjin 301617, China
c Beijing Hospital of Traditional Chinese Medicine, Beijing 100010, China
d The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China
e The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China
f The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300201, China
g Istituto Superiore di Sanità, 00161 Rome, Italy
h University of Oxford, Oxford OX1 3PT, UK
i Korea Institute of Oriental Medicine, Daejeon 34054, Korea
j Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200120, China
k Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
l Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China
m Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China
n The Chinese Cochrane Center, West China Hospital of Sichuan University, Chengdu 610041, China
o The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
p Suqian People’s Hospital of Nanjing Drum-Tower Hospital Group, Suqian 223800, China
q Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617
r Lanzhou University, Lanzhou 730000, China
s The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450099, China
t Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medicine Science, Beijing 100700, China
u Peking University First Hospital, Beijing 100034, China
# These authors contributed equally to this work.
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摘要
自2019年12月新型冠状病毒肺炎（Coronavirus Disease 2019, COVID-19）暴发以来，已有大量相关临床研究完成注册或已启动。然而，不同研究间临床结局指标存在显著的异质性，同时一些不关键的指标会造成研究资源的浪费。本研究旨在构建COVID-19临床试验核心结局指标集（core outcome set, COS），为相关临床研究方案设计、开展和证据转化提供参考。本研究的实施参照《有效性试验核心结局指标（COMET）手册》（1.0版），研究组成员包括呼吸系统和危重医学、中医学、循证医学、临床药理学、统计学专家以及医学杂志编辑等。通过检索临床试验注册网站（chictr.org.cn和clinicaltrials.gov）中COVID-19相关临床研究方案，提取方案中的结局指标，形成指标池。78个COVID-19临床试验方案纳入研究，收集结局指标259个，合并规范后确定132个结局指标，涉及7个指标域。经遴选，形成了包括58个结局指标在内的初始指标清单。经过两轮德尔菲调查和一轮共识会议，最终确立针对COVID-19不同临床分型的核心指标集（COS-COVID）。COS-COVID包括1个轻型指标（病毒核酸检测转阴时间）、4个普通型指标（住院时间、复合事件发生率、临床症状积分和病毒核酸检测转阴时间）、5个重型指标（复合事件发生率、住院时间、PaO2/FiO2、机械通气时间和病毒核酸检测转阴时间）、1个危重型指标（全因死亡率）及1个康复期指标（肺功能）。COS-COVID作为目前临床评价COVID-19干预效果最具临床价值及操作性的指标集合，对证据评估和决策具有重要意义。随着对疾病认知的不断深入和COS-COVID应用的反馈，课题组将对本核心指标集进行进一步完善并更新。
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