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Unmeasured confounding and misclassification in studies estimating vaccine effectiveness against hospitalisation and death using electronic health records (EHRs): an evaluation of a multi-country European retrospective cohort study

2025-12-17Artigo científico Acesso aberto
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dc.contributor.authorHumphreys, James
dc.contributor.authorNicolay, Nathalie
dc.contributor.authorBraeye, Toon
dc.contributor.authorVan Evercooren, Izaak
dc.contributor.authorHolm Hansen, Christian
dc.contributor.authorMoustsen-Helms, Ida Rask
dc.contributor.authorSacco, Chiara
dc.contributor.authorMateo-Urdiales, Alberto
dc.contributor.authorCastilla, Jesús
dc.contributor.authorMartínez-Baz, Iván
dc.contributor.authorMachado, Ausenda
dc.contributor.authorSoares, Patricia
dc.contributor.authorde Gier, Brechje
dc.contributor.authorMeijerink, Hinta
dc.contributor.authorMonge, Susana
dc.contributor.authorBacci, Sabrina
dc.contributor.authorNunes, Baltazar
dc.contributor.authorVEBIS-EHR working group
dc.date.accessioned2026-01-22T10:59:41Z
dc.date.available2026-01-22T10:59:41Z
dc.date.issued2025-12-17
dc.description.abstractBackground: Electronic health record (EHR)-based observational studies can rapidly provide real-world data on vaccine effectiveness (VE), though EHR data may be prone to misclassification and unmeasured confounding. Methods: In VEBIS-EHR, a retrospective multi-country COVID-19 VE cohort study, we examined unmeasured confounding using a negative control outcome (death not related to COVID-19) and misclassification due to timing of data extraction. The evaluation spanned two periods (November-December 2023, January-February 2024), encompassing up to 18.7 million individuals across six EU/EEA countries. Vaccine confounding-adjusted hazard ratios (aHRs) were pooled using random-effects meta-analysis. Results: aHRs against non-COVID-19 mortality ranged from 0.35 (95% CI: 0.28-0.44) to 0.70 (0.66-0.73) when comparing vaccinated versus unvaccinated. Delaying EHR data extraction modestly increased the capture of outcome and exposure events, with some variation by vaccination status. Site-level fluctuations in aHRs did not meaningfully alter the overall pooled VE, suggesting stable estimates despite misclassification related to extraction timing. Conclusions: We observed some evidence of unmeasured confounding when using non-COVID-19 deaths as a negative outcome, though the specificity of our negative control must be considered. This result may suggest overestimation of VE, but also the need for further analysis with more specific negative control outcomes and confounding-adjustment techniques. Addressing such confounding using richer data sources and more refined approaches remains critical to ensure accurate, timely VE estimates based on retrospective cohorts constructed using registry data. Extending the delay between the end of observation and data extraction modestly improves the completeness of exposure and outcome data, with limited effect on pooled VE estimates.eng
dc.description.sponsorshipAll public health organizations involved received funding from the European Centre for Disease Prevention and Control (ECDC) implementing Framework Contract [ECDC/2021/018] ‘Vaccine effectiveness and impact of COVID-19 vaccines through routinely collected exposure and outcome using health registries’ [RS/2022/DTS/24104].
dc.identifier.citationBMC Med Res Methodol. 2025 Dec 17. doi: 10.1186/s12874-025-02742-8
dc.identifier.doi10.1186/s12874-025-02742-8
dc.identifier.issn1471-2288
dc.identifier.pmid41408506
dc.identifier.urihttp://hdl.handle.net/10400.18/10737
dc.language.isoeng
dc.peerreviewedyes
dc.publisherBioMed Central
dc.relationVEBIS-EHR
dc.relation.hasversionhttps://link.springer.com/article/10.1186/s12874-025-02742-8
dc.relation.ispartofBMC Medical Research Methodology
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectBias
dc.subjectCOVID-19
dc.subjectElectronic Health Records
dc.subjectEvaluation
dc.subjectFrailty Bias
dc.subjectHealthy-Vaccinee Bias
dc.subjectMethods
dc.subjectVaccine Effectiveness
dc.subjectEurope
dc.subjectInfecções Respiratórias
dc.subjectEstados de Saúde e de Doença
dc.titleUnmeasured confounding and misclassification in studies estimating vaccine effectiveness against hospitalisation and death using electronic health records (EHRs): an evaluation of a multi-country European retrospective cohort studyeng
dc.typejournal article
dcterms.referenceshttps://link.springer.com/article/10.1186/s12874-025-02742-8#additional-information
dspace.entity.typePublication
oaire.citation.endPage13
oaire.citation.issue1
oaire.citation.startPage1
oaire.citation.titleBMC Medical Research Methodology
oaire.citation.volume26
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameMachado
person.familyNameSoares
person.familyNameNunes
person.givenNameAusenda
person.givenNamePatricia
person.givenNameBaltazar
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person.identifier.ciencia-id1217-6076-5D88
person.identifier.ciencia-id0415-632D-8609
person.identifier.ciencia-idAB11-AD48-A8DF
person.identifier.orcid0000-0002-1849-1499
person.identifier.orcid0000-0001-5033-9115
person.identifier.orcid0000-0001-6230-7209
person.identifier.scopus-author-id52063758300
person.identifier.scopus-author-id9133723200
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relation.isAuthorOfPublication.latestForDiscovery544ad266-0c22-4a50-9ebc-86acc08d6666

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