Reporting and data sharing level for COVID-19 vaccine trials: A cross-sectional study.
Reporting and data sharing level for COVID-19 vaccine trials: A cross-sectional study.
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DOI：
10.1016/j.ebiom.2022.103962
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发表时间：
2022-04
期刊：
影响因子：
11.1
通讯作者：
Bian Z
中科院分区：
文献类型：
--
作者：
Duan Y;Luo J;Zhao L;Zhang X;Miao J;Moher D;Bian Z
疫苗试验的结果和数据可用性直接影响医疗保健提供者、公众和政策制定者是否应该应用疫苗的决定。然而，COVID-19疫苗研究的报告和数据共享水平尚不明确。进行了一项横断面研究。在科克伦Living系统性综述和网络荟萃分析数据库中进行了截至2021年5月9日的系统性检索，并更新了截至2021年7月6日的检索，以识别COVID-19疫苗试验。总结了纳入试验的基本特点。根据CONSORT清单评估报告水平。通过开放科学实践评估数据共享水平。分析了不完整报告的类型，包括方案偏离、主要结局不明确和遗漏伤害。最后，本分析纳入了36篇关于40项随机对照试验的COVID-19疫苗文章。基于CONSORT自评量表，平均报告评分为29.7 [95%置信区间28.7，30.7]。31篇文献（31/36，86.1%）有数据共享声明，25篇文献（25/36，69.4%）提供了源数据的访问。27篇文章（27/36，75.0%）存在方案偏离、主要结局不明确或遗漏伤害。COVID-19疫苗试验的报告和数据共享水平并不理想。我们希望未来试验的报告和数据共享将得到改善。我们建议为未来的疫苗试验建立一个全面、准确的数据共享系统。本研究得到了国家重点研发计划（2019 YFC 1710400; 2019 YFC 1710403）的支持。
The results and data availability of vaccine trials directly affect the decisions of healthcare providers, the public, and policymakers as to whether the vaccine should be applied. However, the reporting and data sharing level of COVID-19 vaccine studies are not clear. A cross-sectional study was conducted. A systematic search up to 9 May 2021 in 12 databases and an updated search to 6 July 2021 were conducted in the Cochrane Living Systematic Review and Network Meta-Analysis database to identify COVID-19 vaccine trials. The basic characteristics of included trials were summarized. The reporting level was assessed according to the CONSORT checklist. The data sharing level was assessed by open science practices. Types of incomplete reporting including protocol deviation, lack of primary outcomes clarity, and the omission of harms were analyzed. Finally, thirty-six COVID-19 vaccine articles reporting on 40 randomized controlled trials were included in this analysis. Based on the CONSORT checklist, the mean reporting score was 29.7 [95% confidence interval 28.7, 30.7]. Thirty-one articles (31/36, 86.1%) had data sharing statements, twenty-five articles (25/36, 69.4%) provided access to the source data. Twenty-seven articles (27/36, 75.0%) had protocol deviation, lack of primary outcomes clarity, or the omission of harms. The reporting and data sharing level of COVID-19 vaccine trials were not optimal. We hope that the reporting and data sharing of future trials will be improved. We recommend establishing a comprehensive, accurate data sharing system for future vaccine trials. This work was supported by the National Key R&D Program of China (2019YFC1710400; 2019YFC1710403).
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影响因子：
3.7
作者：
Korang SK;Juul S;Nielsen EE;Feinberg J;Siddiqui F;Ong G;Klingenberg S;Veroniki AA;Bu F;Thabane L;Thomsen AR;Jakobsen JC;Gluud C
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期刊：
Indian journal of clinical biochemistry : IJCB
影响因子：
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影响因子：
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