Benchimol Eric I, Moher David, Ehrenstein Vera, Langan Sinéad M
Department of Paediatrics, University of Toronto, Toronto, Canada.
Child Health Evaluative Sciences, SickKids Research Institute, and Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Canada.
Clin Epidemiol. 2020 Dec 21;12:1403-1420. doi: 10.2147/CLEP.S288677. eCollection 2020.
Two recent high-profile publications (and subsequent retractions) of pharmacoepidemiology studies reporting the effectiveness and risk of hydroxychloroquine in COVID-19 patients received international media attention. Transparent and complete reporting of these studies could have provided peer reviewers and editors with sufficient information to question the methods used and the validity of results. Since these studies used routinely collected health data, the guidelines for the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) should have been applied to ensure complete reporting of the research.
We evaluated the two retracted articles for completeness of reporting using the RECORD for Pharmacoepidemiology (RECORD-PE) checklist, which includes the checklists for the STengthening the Reporting of OBservational studies in Epidemiology (STROBE) and RECORD. We compared the proportion of STROBE, RECORD and RECORD-PE items adequately reported using Chi-squared statistics.
In the article published by , 29 of 34 STROBE items (85.3%) were adequately reported, compared with 3.5 of 13 RECORD items (26.9%) and 9.5 of 15 RECORD-PE items (63.3%)(χ = 14.839, P <0.001). Similarly, the article published in reported 24 of 34 STROBE items (70.6%), two of 13 RECORD items (15.4%), and 7.5 of 15 RECORD-PE items (50.0%) (χ = 11.668, P = 0.003). Important aspects of the methods unique to research using routinely collected health data were not reported, including variables used to identify exposure, outcome and confounders, validation of the coding or algorithms, a description of the underlying database population and the accuracy of data linkage methods.
While STROBE items were generally adequately reported, RECORD and RECORD-PE items were not. Reporting guidelines should be effectively implemented in order for transparency and completeness of research manuscripts, allowing for adequate evaluation by editors and peer reviewers.
近期两篇备受瞩目的关于羟氯喹在新冠病毒疾病患者中的有效性和风险的药物流行病学研究论文（以及随后的撤稿）受到了国际媒体的关注。对这些研究进行透明且完整的报告本可为同行评审人员和编辑提供足够信息，以便对所使用的方法和结果的有效性提出质疑。由于这些研究使用的是常规收集的健康数据，因此应采用《使用观察性常规收集健康数据进行研究的报告指南》（RECORD）来确保研究报告的完整性。
我们使用药物流行病学RECORD（RECORD - PE）清单评估这两篇撤稿文章的报告完整性，该清单包括《加强流行病学观察性研究报告规范》（STROBE）和RECORD的清单。我们使用卡方统计量比较了STROBE、RECORD和RECORD - PE项目充分报告的比例。
在[某期刊]发表的文章中，34项STROBE项目中有29项（85.3%）得到了充分报告，相比之下，13项RECORD项目中有3.5项（26.9%），15项RECORD - PE项目中有9.5项（63.3%）（χ = 14.839，P <0.001）。同样，在[另一期刊]发表的文章中，34项STROBE项目报告了24项（70.6%），13项RECORD项目报告了2项（15.4%），15项RECORD - PE项目报告了7.5项（50.0%）（χ = 11.668，P = 0.003）。使用常规收集的健康数据进行研究特有的方法的重要方面未被报告，包括用于确定暴露、结局和混杂因素的变量、编码或算法的验证、基础数据库人群的描述以及数据链接方法的准确性。
虽然STROBE项目总体上得到了充分报告，但RECORD和RECORD - PE项目并非如此。应有效实施报告指南，以确保研究稿件的透明度和完整性，便于编辑和同行评审人员进行充分评估。
