Retraction of COVID-19 Pharmacoepidemiology Research Could Have Been Avoided by Effective Use of Reporting Guidelines.
Identifieur interne : 000D07 ( Main/Exploration ); précédent : 000D06; suivant : 000D08Retraction of COVID-19 Pharmacoepidemiology Research Could Have Been Avoided by Effective Use of Reporting Guidelines.
Auteurs : Eric I. Benchimol [Canada] ; David Moher [Canada] ; Vera Ehrenstein [Danemark] ; Sinéad M. Langan [Royaume-Uni]Source :
- Clinical epidemiology [ 1179-1349 ] ; 2020.
Abstract
Introduction
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
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.
DOI: 10.2147/CLEP.S288677
PubMed: 33376409
PubMed Central: PMC7762449
Affiliations:
- Canada, Danemark, Royaume-Uni
- Angleterre, Grand Londres, Ontario
- Londres, Ottawa, Toronto
- Université de Toronto
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Benchimol</name><affiliation wicri:level="4"><nlm:affiliation>Department of Paediatrics, University of Toronto, Toronto, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Paediatrics, University of Toronto, Toronto</wicri:regionArea><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName><orgName type="university">Université de Toronto</orgName></affiliation><affiliation wicri:level="3"><nlm:affiliation>Child Health Evaluative Sciences, SickKids Research Institute, and Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Child Health Evaluative Sciences, SickKids Research Institute, and Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto</wicri:regionArea><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>ICES, Toronto, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>ICES, Toronto</wicri:regionArea><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Moher, David" sort="Moher, David" uniqKey="Moher D" first="David" last="Moher">David Moher</name><affiliation wicri:level="3"><nlm:affiliation>School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>School of Epidemiology and Public Health, University of Ottawa, Ottawa</wicri:regionArea><placeName><settlement type="city">Ottawa</settlement><region type="state">Ontario</region></placeName></affiliation><affiliation wicri:level="3"><nlm:affiliation>Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa</wicri:regionArea><placeName><settlement type="city">Ottawa</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Ehrenstein, Vera" sort="Ehrenstein, Vera" uniqKey="Ehrenstein V" first="Vera" last="Ehrenstein">Vera Ehrenstein</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.</nlm:affiliation><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Clinical Epidemiology, Aarhus University, Aarhus</wicri:regionArea><wicri:noRegion>Aarhus</wicri:noRegion></affiliation></author><author><name sortKey="Langan, Sinead M" sort="Langan, Sinead M" uniqKey="Langan S" first="Sinéad M" last="Langan">Sinéad M. Langan</name><affiliation wicri:level="3"><nlm:affiliation>Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author></analytic><series><title level="j">Clinical epidemiology</title><idno type="ISSN">1179-1349</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>Introduction</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>Methods</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>Results</b></p><p>In the article published by </p></div><div type="abstract" xml:lang="en"><p><b>Discussion</b></p><p>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.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33376409</PMID><DateRevised><Year>2021</Year><Month>01</Month><Day>15</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">1179-1349</ISSN><JournalIssue CitedMedium="Print"><Volume>12</Volume><PubDate><Year>2020</Year></PubDate></JournalIssue><Title>Clinical epidemiology</Title><ISOAbbreviation>Clin Epidemiol</ISOAbbreviation></Journal><ArticleTitle>Retraction of COVID-19 Pharmacoepidemiology Research Could Have Been Avoided by Effective Use of Reporting Guidelines.</ArticleTitle><Pagination><MedlinePgn>1403-1420</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.2147/CLEP.S288677</ELocationID><Abstract><AbstractText Label="Introduction" NlmCategory="UNASSIGNED">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.</AbstractText><AbstractText Label="Methods" NlmCategory="UNASSIGNED">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.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">In the article published by <i>The Lancet</i>, 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<sup>2</sup> = 14.839, P <0.001). Similarly, the article published in <i>NEJM</i> 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<sup>2</sup> = 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.</AbstractText><AbstractText Label="Discussion" NlmCategory="UNASSIGNED">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.</AbstractText><CopyrightInformation>© 2020 Benchimol et al.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Benchimol</LastName><ForeName>Eric I</ForeName><Initials>EI</Initials><Identifier Source="ORCID">0000-0001-8855-3598</Identifier><AffiliationInfo><Affiliation>Department of Paediatrics, University of Toronto, Toronto, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Child Health Evaluative Sciences, SickKids Research Institute, and Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>ICES, Toronto, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moher</LastName><ForeName>David</ForeName><Initials>D</Initials><Identifier Source="ORCID">0000-0003-2434-4206</Identifier><AffiliationInfo><Affiliation>School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ehrenstein</LastName><ForeName>Vera</ForeName><Initials>V</Initials><Identifier Source="ORCID">0000-0002-3415-3254</Identifier><AffiliationInfo><Affiliation>Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Langan</LastName><ForeName>Sinéad M</ForeName><Initials>SM</Initials><AffiliationInfo><Affiliation>Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><Acronym>WT_</Acronym><Agency>Wellcome Trust</Agency><Country>United Kingdom</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>12</Month><Day>21</Day></ArticleDate></Article><MedlineJournalInfo><Country>New Zealand</Country><MedlineTA>Clin Epidemiol</MedlineTA><NlmUniqueID>101531700</NlmUniqueID><ISSNLinking>1179-1349</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">journalology</Keyword><Keyword MajorTopicYN="N">peer review</Keyword><Keyword MajorTopicYN="N">pharmacoepidemiology</Keyword><Keyword MajorTopicYN="N">reporting guidelines</Keyword><Keyword MajorTopicYN="N">routinely collected health data</Keyword></KeywordList><CoiStatement>EIB and SML are co-Chairs of the RECORD Steering Committee. DM serves on the RECORD Steering Committee, serves on the EQUATOR Network Steering Group, and is Director of the Canadian EQUATOR Centre. SML reports grants from Wellcome Trust, during the conduct of the study. The authors report no other potential conflicts of interest for this work.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>10</Month><Day>25</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>12</Month><Day>02</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>12</Month><Day>30</Day><Hour>5</Hour><Minute>20</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>12</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>12</Month><Day>31</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33376409</ArticleId><ArticleId IdType="doi">10.2147/CLEP.S288677</ArticleId><ArticleId IdType="pii">288677</ArticleId><ArticleId IdType="pmc">PMC7762449</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>J Clin Epidemiol. 2016 Nov;79:104-111</Citation><ArticleIdList><ArticleId IdType="pubmed">27343981</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Epidemiol. 2019 Dec;116:26-35</Citation><ArticleIdList><ArticleId IdType="pubmed">31398440</ArticleId></ArticleIdList></Reference><Reference><Citation>PLoS Med. 2007 Oct 16;4(10):e296</Citation><ArticleIdList><ArticleId IdType="pubmed">17941714</ArticleId></ArticleIdList></Reference><Reference><Citation>PLoS Med. 2015 Oct 06;12(10):e1001885</Citation><ArticleIdList><ArticleId IdType="pubmed">26440803</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2014 Jan 11;383(9912):166-75</Citation><ArticleIdList><ArticleId IdType="pubmed">24411645</ArticleId></ArticleIdList></Reference><Reference><Citation>BMJ. 2011 Nov 22;343:d6783</Citation><ArticleIdList><ArticleId IdType="pubmed">22108262</ArticleId></ArticleIdList></Reference><Reference><Citation>BMJ. 2020 Jun 9;369:m2279</Citation><ArticleIdList><ArticleId IdType="pubmed">32518076</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 Jun 25;382(26):2582</Citation><ArticleIdList><ArticleId IdType="pubmed">32501665</ArticleId></ArticleIdList></Reference><Reference><Citation>BMJ. 2018 Nov 14;363:k3532</Citation><ArticleIdList><ArticleId IdType="pubmed">30429167</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 Jun 13;395(10240):1820</Citation><ArticleIdList><ArticleId IdType="pubmed">32511943</ArticleId></ArticleIdList></Reference><Reference><Citation>PLoS Med. 2007 Oct 16;4(10):e297</Citation><ArticleIdList><ArticleId IdType="pubmed">17941715</ArticleId></ArticleIdList></Reference><Reference><Citation>Cochrane Database Syst Rev. 2012 Nov 14;11:MR000030</Citation><ArticleIdList><ArticleId IdType="pubmed">23152285</ArticleId></ArticleIdList></Reference><Reference><Citation>PLoS One. 2012;7(4):e35621</Citation><ArticleIdList><ArticleId IdType="pubmed">22558178</ArticleId></ArticleIdList></Reference><Reference><Citation>Scientometrics. 2020 Aug 5;:1-4</Citation><ArticleIdList><ArticleId IdType="pubmed">32836531</ArticleId></ArticleIdList></Reference><Reference><Citation>BMC Vet Res. 2014 Jan 10;10:10</Citation><ArticleIdList><ArticleId IdType="pubmed">24410882</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Canada</li><li>Danemark</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Ontario</li></region><settlement><li>Londres</li><li>Ottawa</li><li>Toronto</li></settlement><orgName><li>Université de Toronto</li></orgName></list><tree><country name="Canada"><region name="Ontario"><name sortKey="Benchimol, Eric I" sort="Benchimol, Eric I" uniqKey="Benchimol E" first="Eric I" last="Benchimol">Eric I. 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