Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)

Xinyao Jin; Bo Pang; 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

doi:10.1016/j.eng.2020.03.002

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Engineering ›› 2020, Vol. 6 ›› Issue (10) : 1147-1152. DOI: 10.1016/j.eng.2020.03.002

Research

Article

Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID)

Xinyao Jin^a^,^b^,^* ,
Bo Pang^a^,^b^,^* ,
Junhua Zhang^a^,^b ,
Qingquan Liu^c ,
Zhongqi Yang^d ,
Jihong Feng^e ,
Xuezheng Liu^f ,
Lei Zhang^f ,
Baohe Wang^e ,
Yuhong Huang^e ,
Alice Josephine Fauci^g ,
Yuling Ma^h ,
Myeong Soo Leeⁱ ,
Wei’an Yuan^j ,
Yanming Xie^k ,
Jianyuan Tang^l ,
Rui Gao^m ,
Liang Du^b^,ⁿ ,
Shuo Zhang^e ,
Hanmei Qi^o ,
Yu Sun^p ,
Wenke Zheng^a^,^b ,
Fengwen Yang^a^,^b ,
Huizi Chua^a^,^b ,
Keyi Wang^a^,^b ,
Yi Ou^a^,^b ,
Ming Huang^a ,
Yan Zhu^q ,
Jiajie Yu^b^,ⁿ ,
Jinhui Tian^r ,
Min Zhao^s ,
Jingqing Hu^t ,
Chen Yao^u ,
Youping Li^b^,ⁿ ,
Boli Zhang^a^,^q

Author information +

^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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Abstract

Since its outbreak in December 2019, a series of clinical trials on coronavirus disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) Handbook: Version 1.0, a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine (TCM), evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (www.chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019 novel coronavirus (2019-nCoV) reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO₂)/fraction of inspired oxygen (FiO₂), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.

Keywords

Novel coronavirus pneumonia / Core outcome set / COVID-19 / 2019-nCoV / Coronavirus disease / Clinical trials

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Xinyao Jin, Bo Pang, 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. Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID). Engineering, 2020, 6(10): 1147‒1152 https://doi.org/10.1016/j.eng.2020.03.002

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