Clinical Epidemiology (Dec 2020)
Retraction of COVID-19 Pharmacoepidemiology Research Could Have Been Avoided by Effective Use of Reporting Guidelines
Abstract
Eric I Benchimol,1– 3 David Moher,4,5 Vera Ehrenstein,6 Sinéad M Langan7 1Department of Paediatrics, University of Toronto, Toronto, Canada; 2Child Health Evaluative Sciences, SickKids Research Institute, and Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Canada; 3ICES, Toronto, Canada; 4School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada; 5Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada; 6Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark; 7Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UKCorrespondence: Eric I BenchimolDivision of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, 555 University Avenue, Toronto, ON M5G 1X8, CanadaTel +1 416813-1500Fax +1 416813-4972Email [email protected]: 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.Methods: 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.Results: In the article published by The Lancet, 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%)(χ2 = 14.839, P < 0.001). Similarly, the article published in NEJM 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%) (χ2 = 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.Discussion: 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.Keywords: COVID-19, journalology, peer review, pharmacoepidemiology, reporting guidelines, routinely collected health data
