新冠病毒肺炎临床试验核心指标集

• Published in: 工程（英文） Vol. 6; no. 10; pp. 1147 - 中插108
• Main Authors: 金鑫瑶, 庞博, 张俊华, 刘清泉, 杨忠奇, 封继宏, 刘学政, 张磊, 王保和, 黄宇虹, Alice Josephine Fauci, 马玉玲, Myeong Soo Lee, 元唯安, 谢雁鸣, 唐健元, 高蕊, 杜亮, 张硕, 祁寒梅, 孙宇, 郑文科, 杨丰文, 蔡慧姿, 王可仪, 欧益, 黄明, 朱彦, 喻佳洁, 田金徽, 赵敏, 胡镜清, 姚晨, 李幼平, 张伯礼
• Format: Journal Article
• Language: Chinese
• Published: Chinese Clinical Trials Core Outcome Set Research Center, Tianjin 301617, China%Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China%The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China%The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China%The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300201, China%Istituto Superiore di Sanità, Rome 00161, Italy%University of Oxford, Oxford OX13PT, UK%Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea%Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200120, China%Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China%Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China%Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China%Chinese Clinical Trials Core Outcome Set Research Center, Tianjin 301617, China 2020; Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; The Chinese Cochrane Center, West China Hospital of Sichuan University, Chengdu 610041, China%The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China%Suqian People's Hospital of Nanjing Drum-Tower Hospital Group, Suqian 223800, China%Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China%Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China%Lanzhou University, Lanzhou 730000, China%The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450099, China%Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medicine Science, Beijing 100700, China%Peking University First Hospital, Beijing 100034, China
• Subjects: COVID-19; 冠状病毒疾病; 核心指标集; Coronavirus disease; Clinical trials; 2019-nCoV; 临床试验; Core outcome set
• ISSN: 2095-8099

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.