Biases in evaluating the safety and effectiveness of drugs for covid-19: designing real-world evidence studies.
Identifieur interne : 000707 ( Main/Exploration ); précédent : 000706; suivant : 000708Biases in evaluating the safety and effectiveness of drugs for covid-19: designing real-world evidence studies.
Auteurs : Christel Renoux [Canada] ; Laurent Azoulay [Canada] ; Samy Suissa [Canada]Source :
- American journal of epidemiology [ 1476-6256 ] ; 2021.
Abstract
The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to an unprecedented effort to generate real-world evidence on the safety and effectiveness of various treatments. A growing number of observational studies evaluating the effects of certain drugs have been conducted, including several assessing whether hydroxychloroquine improves outcomes in infected individuals and whether renin-angiotensin-aldosterone system inhibitors have detrimental effects. We review and illustrate how immortal time bias and selection bias were present in several of these studies. Understanding these biases and how they can be avoided may prove important for future observational studies assessing the effectiveness and safety of potentially promising drugs during the COVID-19 pandemic.
DOI: 10.1093/aje/kwab028
PubMed: 33564823
PubMed Central: PMC7929453
Affiliations:
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A growing number of observational studies evaluating the effects of certain drugs have been conducted, including several assessing whether hydroxychloroquine improves outcomes in infected individuals and whether renin-angiotensin-aldosterone system inhibitors have detrimental effects. We review and illustrate how immortal time bias and selection bias were present in several of these studies. Understanding these biases and how they can be avoided may prove important for future observational studies assessing the effectiveness and safety of potentially promising drugs during the COVID-19 pandemic.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33564823</PMID><DateRevised><Year>2021</Year><Month>03</Month><Day>05</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1476-6256</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2021</Year><Month>Feb</Month><Day>10</Day></PubDate></JournalIssue><Title>American journal of epidemiology</Title><ISOAbbreviation>Am J Epidemiol</ISOAbbreviation></Journal><ArticleTitle>Biases in evaluating the safety and effectiveness of drugs for covid-19: designing real-world evidence studies.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">kwab028</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1093/aje/kwab028</ELocationID><Abstract><AbstractText>The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to an unprecedented effort to generate real-world evidence on the safety and effectiveness of various treatments. A growing number of observational studies evaluating the effects of certain drugs have been conducted, including several assessing whether hydroxychloroquine improves outcomes in infected individuals and whether renin-angiotensin-aldosterone system inhibitors have detrimental effects. We review and illustrate how immortal time bias and selection bias were present in several of these studies. Understanding these biases and how they can be avoided may prove important for future observational studies assessing the effectiveness and safety of potentially promising drugs during the COVID-19 pandemic.</AbstractText><CopyrightInformation>© The Author(s) 2021. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. 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