Reports of clinical trial protocols of coronavirus disease 2019: a systematic review

TMR Integrative Medicine

article

Rui-Jin Qiu¹  Xu-Xu Wei¹  Meng-Zhu Zhao²  Chang-Ming Zhong¹  Chen Zhao³  Jia-Yuan Hu¹  Min Li⁴  Ya Huang¹  Song-Jie Han¹  Tian-Mai He¹  Jing Chen⁵  Hong-Cai Shang¹ 

[1] Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen Hospital, Beijing University of Chinese Medicine;First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Beijing University of Chinese Medicine Third Affiliated Hospital;Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

关键词: outcomes;    clinical trials;    COVID-19;    review;   

DOI  :  10.53388/TMRIM202206005

学科分类：医学（综合）

来源: TMR publishing group

【 摘 要 】

Background: To examine the outcomes heterogeneity of clinical trial protocols of coronavirus disease 2019 (COVID-19) to prioritizethe establishment of a core outcome set. Methods: Databases of the International Committee of Medical Journal Editors – acceptedclinical trial registry platforms were searched on February 14, 2020 and May 31, 2020. Randomized controlled trials andnon-randomized controlled trials of COVID-19 were considered. Patient condition was classified as common, severe, or critical. Interventions included traditional Chinese medicine and Western medicine. We excluded trials that involved discharged patients, psychological intervention, and complications of COVID-19. The general information and outcomes, outcome measurementinstruments, and measurement times were extracted. The results were analyzed by descriptive analysis. Results: In all, 19 registryplatforms were searched. A total of 97 protocols were selected from among 160 protocols for the first search. For protocols oftraditional Chinese medicine clinical trials, 76 outcomes from 16 outcome domains were reported, and almost half (34/76, 44.74%) ofthe outcomes were reported only once; the most frequently reported outcome was time taken for severe acute respiratory syndromecoronavirus 2 RNA to become negative. Twenty-seven (27/76, 35.53%) outcomes provided one or more outcome measurementinstruments. Ten outcomes provided one or more measurement time frame. For protocols of Western medicine clinical trials, 126outcomes from 17 outcome domains were reported; almost half (62/126, 49.21%) of the outcomes were reported only once; the mostfrequently reported outcome was proportion of patients with negative severe acute respiratory syndrome coronavirus 2. Twenty-sevenoutcomes provided one or more outcome measurement instruments. Forty (40/126, 31.75%) outcomes provided one or more measurement time frame. There were > 40 duplicated outcomes between the clinical trials protocols of traditional Chinese medicineand western medicine protocols. All of them were included in the Delphi survey when developing core outcome set for COVID-19. Atotal of 1,027 protocols were selected from 2,741 protocols for the second search. Forty-two new outcomes and 47 new outcome measurement instruments were reported. Conclusion: Outcome reporting in clinical trial protocols of COVID-19 is inconsistent. Thus, establishing a core outcome set is necessary for diagnosis and management.

【 授权许可】

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