Logo do repositório
 
Publicação

The potential bias introduced into COVID-19 vaccine effectiveness studies at primary care level due to the availability of SARS-CoV-2 tests in the general population

2025-06-11Artigo científico Acesso aberto
Ver registo simples
dc.contributor.authorLanièce Delaunay, Charlotte
dc.contributor.authorNunes, Baltazar
dc.contributor.authorMonge, Susana
dc.contributor.authorde Lange, Marit
dc.contributor.authorTúri, Gergő
dc.contributor.authorMachado, Ausenda
dc.contributor.authorLatorre-Margalef, Neus
dc.contributor.authorMlinarić, Ivan
dc.contributor.authorLazar, Mihaela
dc.contributor.authorBotella Rocamora, Paloma
dc.contributor.authorErdwiens, Annika
dc.contributor.authorSève, Noémie
dc.contributor.authorDomegan, Lisa
dc.contributor.authorMartínez-Baz, Iván
dc.contributor.authorHooiveld, Mariëtte
dc.contributor.authorOroszi, Beatrix
dc.contributor.authorGuiomar, Raquel
dc.contributor.authorSperk, Maike
dc.contributor.authorKurečić Filipović, Sanja
dc.contributor.authorPascu, Catalina
dc.contributor.authorLinares Dopido, Juan Antonio
dc.contributor.authorDürrwald, Ralf
dc.contributor.authorRameix-Welti, Marie-Anne
dc.contributor.authorMcKenna, Adele
dc.contributor.authorCastilla, Jesús
dc.contributor.authorvan Hagen, Cheyenne
dc.contributor.authorKnol, Mirjam
dc.contributor.authorBacci, Sabrina
dc.contributor.authorKaczmarek, Marlena
dc.contributor.authorKissling, Esther
dc.contributor.authorVEBIS Primary Care Vaccine Effectiveness Group
dc.date.accessioned2026-02-19T16:28:21Z
dc.date.available2026-02-19T16:28:21Z
dc.date.issued2025-06-11
dc.description.abstractBackground: With SARS-CoV-2 self-tests, persons with acute respiratory infections (ARI) can know their COVID-19 status. This may alter their decision to consult a general practitioner (GP), potentially biasing COVID-19 vaccine effectiveness (VE) studies. We explore bias mechanisms, simulate magnitude, and verify control methods. Methods: We used directed acyclic graphs (DAGs) to illustrate the bias mechanisms. Based on the European primary care VEBIS multicentre test-negative design (TND) study, we simulated populations with varying true VE (20%-60%), proportions of persons with ARI self-testing (10%-30%), effect of COVID-19 vaccination on self-testing (1.5-2.5), and effect of self-test result on GP consultation (0.5-2). We performed 5000 runs per scenario, estimating VE among those consulting a GP. We calculated bias as true VE minus mean simulated VE, unadjusted and adjusted for self-testing, using logistic regression. Results: DAGs suggested collider stratification bias if vaccination had an effect on self-testing and if self-test results affected GP consultation. Bias was -12% to 18% at 20% true VE, with the most extreme associations and 30% self-testing. With 60% true VE and 10%-20% self-testing, bias was lower. Bias was higher (-18% to 45%) if both positive and negative self-test results affected GP consultation. Adjusting for self-testing removed the bias. Conclusions: Self-testing may bias COVID-19 VE TND studies in primary care if self-testing is high, particularly with low VE. We recommend primary care TND VE studies collect self-testing information to eliminate potential bias. Observational studies are needed to understand the relationship between vaccination, self-testing, and GP consultation, in these studies' source population.eng
dc.description.abstractKey Messages: - We investigated how the use of SARS-CoV-2 tests in the general population could bias COVID-19 vaccine effectiveness studies at the primary care level, and how to mitigate this bias. - Using directed acyclic graphs and data simulations, we showed that COVID-19 vaccine effectiveness could be biased due to self-test use, and that adjusting for self-testing removed this bias.- Our findings have major implications for the validity of test-negative, case–control vaccine effectiveness studies and suggest that straightforward analytical techniques can be used to correct for bias of a potentially large magnitude.eng
dc.description.sponsorshipThis study received funding from the European Centre for Disease Prevention and Control (ECDC), through the framework contract Vaccine Effectiveness, Burden and Impact Studies (VEBIS) of COVID-19 and Influenza ECDC/2021/019.
dc.identifier.citationInt J Epidemiol. 2025 Jun 11;54(4):dyaf086. doi: 10.1093/ije/dyaf086
dc.identifier.doi10.1093/ije/dyaf086
dc.identifier.issn0300-5771
dc.identifier.pmid40534212
dc.identifier.urihttp://hdl.handle.net/10400.18/10955
dc.language.isoen
dc.peerreviewedyes
dc.publisherOxford University Press
dc.relation.hasversionhttps://academic.oup.com/ije/article/54/4/dyaf086/8168944
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectCOVID-19
dc.subjectSARS-CoV-2
dc.subjectBias
dc.subjectPrimary Health Care
dc.subjectSelf-testing
dc.subjectVaccine Effectiveness
dc.subjectInfecções Respiratórias
dc.subjectEstados de Saúde e de Doença
dc.titleThe potential bias introduced into COVID-19 vaccine effectiveness studies at primary care level due to the availability of SARS-CoV-2 tests in the general populationpor
dc.typejournal article
dcterms.referenceshttps://github.com/epi-gde/STATA-SIMUL
dspace.entity.typePublication
oaire.citation.issue4
oaire.citation.startPagedyaf086
oaire.citation.titleInternational Journal of Epidemiology
oaire.citation.volume54
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

Ficheiros

Principais
A mostrar 1 - 1 de 1
Miniatura indisponível
Nome:
dyaf086.pdf
Tamanho:
1.13 MB
Formato:
Adobe Portable Document Format
Ver/Abrir
Licença
A mostrar 1 - 1 de 1
Miniatura indisponível
Nome:
license.txt
Tamanho:
4.03 KB
Formato:
Item-specific license agreed upon to submission
Descrição:
Ver/Abrir

Coleções

DEP - Artigos em revistas internacionais
DDI - Artigos em revistas internacionais
INSA - Artigos em revistas internacionais