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| Outcomes and related issues of clinical trials for COVID-19 |
| Hits 1021 Download times 666 Received:March 05, 2020 |
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| DOI
10.11656/j.issn.1672-1519.2020.10.08 |
| Key Words
coronavirus disease 2019;clinical trial;outcome;core outcome set |
| Author Name | Affiliation | E-mail | | JIN Xinyao | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | PANG Bo | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Hui | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Keyi | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | PANG Wentai | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHENG Wenke | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | LIU Chunxiang | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | YANG Fengwen | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Yonggang | Chinese Evidence-based Medicine Center, West China Hospital of Sichuan University, Chengdu 610041, China | | | YU Chunquan | Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | ycq-4@163.com。 | | ZHANG Junhua | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | zjhtcm@foxmail.com |
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| Abstract
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| [Objective] To analyze the outcomes in registered clinical trial protocols for coronavirus disease 2019 (COVID-19),in order to provide information for improving the rationality of outcomes of relative research as well as for developing core outcome set.[Methods] The website of the Clinical Trial Registry www.chictr.org.cn and clinicaltrials.gov were searched with the key words of novel coronavirus pneumonia,2019-nCOV,COVID-19. Research protocols of all kinds of interventions for COVID-19 were screened,and data were extracted in regard to basic information as well as outcomes. Descriptive analysis was conducted.[Results] A total of 78 research protocols on COVID-19 were included. 259 outcomes were reported with a frequency of 596,including 104 primary outcomes with 184 times and 205 secondary outcomes with 412 times. The number of outcomes adopted by a single research ranged from 1 to 15,with an average of 8. After standardization,132 outcomes were finally concluded from the 259,covering 8 domains of clinical symptoms,laboratory examination,etiology test,important clinical events,quality of life,prognosis,traditional Chinese medicine indicators and safety index.[Conclusion] There were several problems in the outcomes adopted in clinical study protocols of COVID-19,such as irregular expression,unclear timing of measurement,significant outcomes difference among similar researches and mismatch of target and research purpose as well. It is necessary to establish a core outcome set for clinical trials of COVID-19 (COS-COVID),so as to provide references for the optimization of relevant protocols and the development of new researches. |
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