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关于 COVID-19 的原始数据、预印本文章和注册临床试验方案的期刊文章的研究方法和特征。

Research methodology and characteristics of journal articles with original data, preprint articles and registered clinical trial protocols about COVID-19.

机构信息

Faculty of Medicine, University of Tuzla, Tuzla, Bosnia and Herzegovina.

Department of Public Health, Faculty of Medicine, Osijek, Croatia.

出版信息

BMC Med Res Methodol. 2020 Jun 22;20(1):161. doi: 10.1186/s12874-020-01047-2.

Abstract

BACKGROUND

The research community reacted rapidly to the emergence of COVID-19. We aimed to assess characteristics of journal articles, preprint articles, and registered trial protocols about COVID-19 and its causal agent SARS-CoV-2.

METHODS

We analyzed characteristics of journal articles with original data indexed by March 19, 2020, in World Health Organization (WHO) COVID-19 collection, articles published on preprint servers medRxiv and bioRxiv by April 3, 2010. Additionally, we assessed characteristics of clinical trials indexed in the WHO International Clinical Trials Registry Platform (WHO ICTRP) by April 7, 2020.

RESULTS

Among the first 2118 articles on COVID-19 published in scholarly journals, 533 (25%) contained original data. The majority was published by authors from China (75%) and funded by Chinese sponsors (75%); a quarter was published in the Chinese language. Among 312 articles that self-reported study design, the most frequent were retrospective studies (N = 88; 28%) and case reports (N = 86; 28%), analyzing patients' characteristics (38%). Median Journal Impact Factor of journals where articles were published was 5.099. Among 1088 analyzed preprint articles, the majority came from authors affiliated in China (51%) and were funded by sources in China (46%). Less than half reported study design; the majority were modeling studies (62%), and analyzed transmission/risk/prevalence (43%). Of the 927 analyzed registered trials, the majority were interventional (58%). Half were already recruiting participants. The location for the conduct of the trial in the majority was China (N = 522; 63%). The median number of planned participants was 140 (range: 1 to 15,000,000). Registered intervention trials used highly heterogeneous primary outcomes and tested highly heterogeneous interventions; the most frequently studied interventions were hydroxychloroquine (N = 39; 7.2%) and chloroquine (N = 16; 3%).

CONCLUSIONS

Early articles on COVID-19 were predominantly retrospective case reports and modeling studies. The diversity of outcomes used in intervention trial protocols indicates the urgent need for defining a core outcome set for COVID-19 research. Chinese scholars had a head start in reporting about the new disease, but publishing articles in Chinese may limit their global reach. Mapping publications with original data can help finding gaps that will help us respond better to the new public health emergency.

摘要

背景

研究界对 COVID-19 的出现做出了迅速反应。我们旨在评估有关 COVID-19 及其病原体 SARS-CoV-2 的期刊文章、预印本文章和注册试验方案的特征。

方法

我们分析了 2020 年 3 月 19 日前在世界卫生组织(WHO)COVID-19 数据库中索引的具有原始数据的期刊文章、2020 年 4 月 3 日前在预印本服务器 medRxiv 和 bioRxiv 上发表的文章、以及 2020 年 4 月 7 日前在世界卫生组织国际临床试验注册平台(WHO ICTRP)中索引的临床试验的特征。

结果

在学术期刊上发表的首批 2118 篇有关 COVID-19 的文章中,有 533 篇(25%)包含原始数据。这些文章主要来自中国的作者(75%),并由中国的赞助商资助(75%);四分之一以中文发表。在 312 篇报告研究设计的文章中,最常见的是回顾性研究(88 篇;28%)和病例报告(86 篇;28%),分析了患者的特征(38%)。文章发表的期刊的平均期刊影响因子为 5.099。在 1088 篇分析的预印本文章中,大多数来自中国的作者(51%),并由中国的资金来源资助(46%)。不到一半的文章报告了研究设计;大多数是建模研究(62%),分析传播/风险/流行情况(43%)。在 927 篇分析的注册试验中,大多数是干预性的(58%)。一半已经开始招募参与者。大多数试验的实施地点在中国(522 个;63%)。计划参与者的中位数为 140 人(范围:1 至 15000000 人)。注册的干预试验使用了高度异质的主要结局,并测试了高度异质的干预措施;研究最多的干预措施是羟氯喹(39 篇;7.2%)和氯喹(16 篇;3%)。

结论

早期关于 COVID-19 的文章主要是回顾性病例报告和建模研究。干预试验方案中使用的结果多样性表明,迫切需要为 COVID-19 研究定义一个核心结局集。中国学者在报道新疾病方面处于领先地位,但以中文发表文章可能会限制其在全球的影响力。绘制具有原始数据的出版物可以帮助发现差距,这将有助于我们更好地应对新的公共卫生紧急情况。

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