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Core Outcome Set for Clinical Trials on Coronavirus Disease 2019(COS-COVID) 被引量:9
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作者 Xinyao Jin Bo Pang +32 位作者 Junhua Zhang Qingquan Liu Zhongqi Yang Jihong Feng Xuezheng Liu Lei Zhang Baohe Wang Yuhong Huang Alice Josephine Fauci Yuling Ma Myeong Soo Lee Wei’an Yuan Yanming Xie Jianyuan Tang Rui Gao Liang Du Shuo Zhang Hanmei Qi Yu Sun Wenke Zheng Fengwen Yang Huizi Chua Keyi Wang Yi Ou Ming Huang Yan Zhu Jiajie Yu Jinhui Tian Min Zhao Jingqing Hu Chen Yao Youping Li Boli Zhang 《Engineering》 SCIE EI 2020年第10期1294-1300,共7页
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... 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。 展开更多
关键词 核心指标集 COVID-19 2019-nCoV 冠状病毒疾病 临床试验
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Systematic Reviews/Meta-Analyses of Integrative Medicine in Chinese Need Regulation and Monitoring Urgently and Some Suggestions for Its Solutions 被引量:1
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作者 WANG Jia-ying TIAN Gui-hua +4 位作者 LI You-ping WU Tai-xiang BIAN Zhao-xiang DU Liang SHANG Hong-cai 《Chinese Journal of Integrative Medicine》 SCIE CAS CSCD 2018年第2期83-86,共4页
With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine(IM) and has become a new unique discipline. During almost 20 years, as one of... With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine(IM) and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review(SR)/meta-analysis(MA) of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, formingqualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process. 展开更多
关键词 integrative medicine systematic review in Chinese regulation and monitoring
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