File Download

There are no files associated with this item.

  Links for fulltext
     (May Require Subscription)
Supplementary

Article: Theoretical framework for retrospective studies of the effectiveness of SARS-CoV-2 vaccines

TitleTheoretical framework for retrospective studies of the effectiveness of SARS-CoV-2 vaccines
Authors
Issue Date2021
PublisherLippincott Williams & Wilkins. The Journal's web site is located at http://www.epidem.com
Citation
Epidemiology, 2021, July, v. 32 n. 4, p. 508-517 How to Cite?
AbstractObservational studies of the effectiveness of vaccines to prevent COVID-19 are needed to inform real-world use. Such studies are now underway amid the ongoing rollout of SARS-CoV-2 vaccines globally. Although traditional case-control and test-negative design studies feature prominently among strategies used to assess vaccine effectiveness, such studies may encounter important threats to validity. Here, we review the theoretical basis for estimation of vaccine direct effects under traditional case-control and test-negative design frameworks, addressing specific natural history parameters of SARS-CoV-2 infection and COVID-19 relevant to these designs. Bias may be introduced by misclassification of cases and controls, particularly when clinical case criteria include common, nonspecific indicators of COVID-19. When using diagnostic assays with high analytical sensitivity for SARS-CoV-2 detection, individuals testing positive may be counted as cases even if their symptoms are due to other causes. The traditional case-control design may be particularly prone to confounding due to associations of vaccination with healthcare-seeking behavior or risk of infection. The test-negative design reduces but may not eliminate this confounding, for instance, if individuals who receive vaccination seek care or testing for less-severe illness. These circumstances indicate the two study designs cannot be applied naively to datasets gathered through public health surveillance or administrative sources. We suggest practical strategies to reduce bias in vaccine effectiveness estimates at the study design and analysis stages.
Persistent Identifierhttp://hdl.handle.net/10722/300341
ISSN
2023 Impact Factor: 4.7
2023 SCImago Journal Rankings: 0.655
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorLewnard, JA-
dc.contributor.authorPatel, MM-
dc.contributor.authorJewell, NP-
dc.contributor.authorVerani, JR-
dc.contributor.authorKobayashi, M-
dc.contributor.authorTenforde, MW-
dc.contributor.authorDean, NE-
dc.contributor.authorCowling, BJ-
dc.contributor.authorLopman, BA-
dc.date.accessioned2021-06-04T08:41:33Z-
dc.date.available2021-06-04T08:41:33Z-
dc.date.issued2021-
dc.identifier.citationEpidemiology, 2021, July, v. 32 n. 4, p. 508-517-
dc.identifier.issn1044-3983-
dc.identifier.urihttp://hdl.handle.net/10722/300341-
dc.description.abstractObservational studies of the effectiveness of vaccines to prevent COVID-19 are needed to inform real-world use. Such studies are now underway amid the ongoing rollout of SARS-CoV-2 vaccines globally. Although traditional case-control and test-negative design studies feature prominently among strategies used to assess vaccine effectiveness, such studies may encounter important threats to validity. Here, we review the theoretical basis for estimation of vaccine direct effects under traditional case-control and test-negative design frameworks, addressing specific natural history parameters of SARS-CoV-2 infection and COVID-19 relevant to these designs. Bias may be introduced by misclassification of cases and controls, particularly when clinical case criteria include common, nonspecific indicators of COVID-19. When using diagnostic assays with high analytical sensitivity for SARS-CoV-2 detection, individuals testing positive may be counted as cases even if their symptoms are due to other causes. The traditional case-control design may be particularly prone to confounding due to associations of vaccination with healthcare-seeking behavior or risk of infection. The test-negative design reduces but may not eliminate this confounding, for instance, if individuals who receive vaccination seek care or testing for less-severe illness. These circumstances indicate the two study designs cannot be applied naively to datasets gathered through public health surveillance or administrative sources. We suggest practical strategies to reduce bias in vaccine effectiveness estimates at the study design and analysis stages.-
dc.languageeng-
dc.publisherLippincott Williams & Wilkins. The Journal's web site is located at http://www.epidem.com-
dc.relation.ispartofEpidemiology-
dc.rightsThis is a non-final version of an article published in final form in (provide complete journal citation)-
dc.titleTheoretical framework for retrospective studies of the effectiveness of SARS-CoV-2 vaccines-
dc.typeArticle-
dc.identifier.emailCowling, BJ: bcowling@hku.hk-
dc.identifier.authorityCowling, BJ=rp01326-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1097/EDE.0000000000001366-
dc.identifier.pmid34001753-
dc.identifier.pmcidPMC8168935-
dc.identifier.scopuseid_2-s2.0-85107085912-
dc.identifier.hkuros322671-
dc.identifier.volumePublish Ahead of Print-
dc.identifier.issue4-
dc.identifier.spage508-
dc.identifier.epage517-
dc.identifier.isiWOS:000657094500011-
dc.publisher.placeUnited States-

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats