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COVID-19 相关医学研究:元研究与批判性评价。

COVID-19-related medical research: a meta-research and critical appraisal.

机构信息

Paris Translational Research Epidemiology and Biostatistics Department, Hôpital Necker, 149 rue de Sèvres, 75015, Paris, France.

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.

出版信息

BMC Med Res Methodol. 2021 Jan 4;21(1):1. doi: 10.1186/s12874-020-01190-w.

Abstract

BACKGROUND

Since the start of the COVID-19 outbreak, a large number of COVID-19-related papers have been published. However, concerns about the risk of expedited science have been raised. We aimed at reviewing and categorizing COVID-19-related medical research and to critically appraise peer-reviewed original articles.

METHODS

The data sources were Pubmed, Cochrane COVID-19 register study, arXiv, medRxiv and bioRxiv, from 01/11/2019 to 01/05/2020. Peer-reviewed and preprints publications related to COVID-19 were included, written in English or Chinese. No limitations were placed on study design. Reviewers screened and categorized studies according to i) publication type, ii) country of publication, and iii) topics covered. Original articles were critically appraised using validated quality assessment tools.

RESULTS

Among the 11,452 publications identified, 10,516 met the inclusion criteria, among which 7468 (71.0%) were peer-reviewed articles. Among these, 4190 publications (56.1%) did not include any data or analytics (comprising expert opinion pieces). Overall, the most represented topics were infectious disease (n = 2326, 22.1%), epidemiology (n = 1802, 17.1%), and global health (n = 1602, 15.2%). The top five publishing countries were China (25.8%), United States (22.3%), United Kingdom (8.8%), Italy (8.1%) and India (3.4%). The dynamic of publication showed that the exponential growth of COVID-19 peer-reviewed articles was mainly driven by publications without original data (mean 261.5 articles ± 51.1 per week) as compared with original articles (mean of 69.3 ± 22.3 articles per week). Original articles including patient data accounted for 713 (9.5%) of peer-reviewed studies. A total of 576 original articles (80.8%) showed intermediate to high risk of bias. Last, except for simulation studies that mainly used large-scale open data, the median number of patients enrolled was of 102 (IQR = 37-337).

CONCLUSIONS

Since the beginning of the COVID-19 pandemic, the majority of research is composed by publications without original data. Peer-reviewed original articles with data showed a high risk of bias and included a limited number of patients. Together, these findings underscore the urgent need to strike a balance between the velocity and quality of research, and to cautiously consider medical information and clinical applicability in a pressing, pandemic context. SYSTEMATIC REVIEW REGISTRATION: https://osf.io/5zjyx/.

摘要

背景

自 COVID-19 疫情爆发以来,大量与 COVID-19 相关的论文已发表。然而,人们对加速科学的风险表示担忧。我们旨在审查和分类与 COVID-19 相关的医学研究,并批判性地评估同行评议的原始文章。

方法

数据来源包括 Pubmed、Cochrane COVID-19 注册研究、arXiv、medRxiv 和 bioRxiv,时间范围为 2019 年 11 月 1 日至 2020 年 5 月 1 日。纳入了与 COVID-19 相关的同行评议和预印本出版物,以英语或中文撰写。对研究设计没有任何限制。审查员根据 i)出版物类型、ii)出版国家和 iii)涵盖的主题对研究进行筛选和分类。使用经过验证的质量评估工具对原始文章进行批判性评估。

结果

在确定的 11452 篇出版物中,有 10516 篇符合纳入标准,其中 7468 篇(71.0%)为同行评议文章。其中,4190 篇出版物(56.1%)未包含任何数据或分析(包括专家意见文章)。总体而言,最具代表性的主题是传染病(n=2326,22.1%)、流行病学(n=1802,17.1%)和全球健康(n=1602,15.2%)。排名前五的出版国家是中国(25.8%)、美国(22.3%)、英国(8.8%)、意大利(8.1%)和印度(3.4%)。出版的动态表明,COVID-19 同行评议文章的指数级增长主要是由没有原始数据的出版物驱动的(每周平均 261.5 篇±51.1 篇),而原始文章的每周平均为 69.3±22.3 篇。包括患者数据的原始文章占同行评议研究的 713 篇(9.5%)。共有 576 篇原始文章(80.8%)显示出中度至高度偏倚风险。最后,除了主要使用大规模开放数据的模拟研究外,纳入的患者中位数为 102(IQR=37-337)。

结论

自 COVID-19 大流行开始以来,大多数研究都是由没有原始数据的出版物组成的。具有数据的同行评议原始文章显示出较高的偏倚风险,且纳入的患者数量有限。这些发现共同强调了在紧迫的大流行背景下,迫切需要在研究的速度和质量之间取得平衡,并谨慎考虑医疗信息和临床适用性。系统评价注册:https://osf.io/5zjyx/。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4c69/7780669/6b03cea0a3e9/12874_2020_1190_Fig1_HTML.jpg

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