Zobraziť v EDS

Applying two approaches to detect unmeasured confounding due to time-varying variables in a self-controlled risk interval design evaluating COVID-19 vaccine safety signals, using myocarditis as a case example

Uložené v:
Podrobná bibliografia
Názov: Applying two approaches to detect unmeasured confounding due to time-varying variables in a self-controlled risk interval design evaluating COVID-19 vaccine safety signals, using myocarditis as a case example
Autori: Sophie H Bots, Svetlana Belitser, Rolf H H Groenwold, Carlos E Durán, Judit Riera-Arnau, Anna Schultze, Davide Messina, Elena Segundo, Ian Douglas, Juan José Carreras, Patricia Garcia-Poza, Rosa Gini, Consuelo Huerta, Mar Martín-Pérez, Ivonne Martin, Olga Paoletti, Carlo Alberto Bissacco, Elisa Correcher-Martínez, Patrick Souverein, Arantxa Urchueguía-Fornes, Felipe Villalobos, Miriam C J M Sturkenboom, Olaf H Klungel
Prispievatelia: Institut Català de la Salut, [Bots SH, Belitser S] Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. [Groenwold RHH] Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands. [Durán CE] Department of Data Science and Biostatistics, Julius Center for Health Sciences and Primary Health, University Medical Center Utrecht, Utrecht, The Netherlands. [Riera-Arnau J] Department of Data Science and Biostatistics, Julius Center for Health Sciences and Primary Health, University Medical Center Utrecht, Utrecht, The Netherlands. Servei de Farmacologia Clínica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Schultze A] Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK, Vall d'Hebron Barcelona Hospital Campus, RWE/Causal inference, Datascience, Data Science & Biostatistiek, Child Health, Infection & Immunity
Zdroj: Am J Epidemiol
AMERICAN JOURNAL OF EPIDEMIOLOGY
r-FISABIO. Repositorio Institucional de Producción Científica
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Scientia
Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname
Informácie o vydavateľovi: Oxford University Press (OUP), 2024.
Rok vydania: 2024
Predmety: ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::miocardiopatías::miocarditis, pharmacoepidemiology, Practice of Epidemiology, COMPUESTOS QUÍMICOS Y DROGAS::mezclas complejas::productos biológicos::vacunas, COVID-19 vaccine safety, General Medicine, Miocarditis - Epidemiologia, PUBLIC HEALTH::Epidemiology and Biostatistics::Epidemiology::Causality::Confounding Factors (Epidemiology), self-controlled risk interval design, 03 medical and health sciences, 0302 clinical medicine, SDG 3 - Good Health and Well-being, SALUD PÚBLICA::epidemiología y bioestadística::epidemiología::causalidad::factores de confusión (epidemiología), DISEASES::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections, negative controls, ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus, quantitative bias analysis, CHEMICALS AND DRUGS::Complex Mixtures::Biological Products::Vaccines, DISEASES::Cardiovascular Diseases::Heart Diseases::Cardiomyopathies::Myocarditis, COVID-19 (Malaltia) - Vacunació
Popis: We test the robustness of the self-controlled risk interval (SCRI) design in a setting where time between doses may introduce time-varying confounding, using both negative control outcomes (NCOs) and quantitative bias analysis (QBA). All vaccinated cases identified from 5 European databases between September 1, 2020, and end of data availability were included. Exposures were doses 1-3 of the Pfizer, Moderna, AstraZeneca, and Janssen COVID-19 vaccines; outcomes were myocarditis and, as the NCO, otitis externa. The SCRI used a 60-day control window and dose-specific 28-day risk windows, stratified by vaccine brand and adjusted for calendar time. The QBA included two scenarios: (1) baseline probability of the confounder was higher in the control window and (2) vice versa. The NCO was not associated with any of the COVID-19 vaccine types or doses except Moderna dose 1 (IRR = 1.09; 95% CI 1.01-1.09). The QBA suggested that even the strongest literature-reported confounder (COVID-19; RR for myocarditis = 18.3) could only explain away part of the observed effect, from IRR = 3 to IRR = 1.40. The SCRI seems robust to unmeasured confounding in the COVID-19 setting, although a strong unmeasured confounder could bias the observed effect upward. Replication of our findings for other safety signals would strengthen this conclusion. This article is part of a Special Collection on Pharmacoepidemiology.
Druh dokumentu: Article
Other literature type
Popis súboru: application/pdf
Jazyk: English
ISSN: 1476-6256
0002-9262
DOI: 10.1093/aje/kwae172
Prístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/38960670
https://fisabio.portalinvestigacion.com/publicaciones/17770
http://hdl.handle.net/11351/12711
https://research-portal.uu.nl/en/publications/6f75e5b7-0841-4e5c-8a03-84076741ab6f
https://doi.org/10.1093/aje/kwae172
https://dspace.library.uu.nl/handle/1874/458261
https://hdl.handle.net/1887/4215002
Rights: CC BY
URL: http://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Prístupové číslo: edsair.doi.dedup.....b4950d5fe239ec431f67a8a13fe2b10c
Databáza: OpenAIRE
Popis
Abstrakt:We test the robustness of the self-controlled risk interval (SCRI) design in a setting where time between doses may introduce time-varying confounding, using both negative control outcomes (NCOs) and quantitative bias analysis (QBA). All vaccinated cases identified from 5 European databases between September 1, 2020, and end of data availability were included. Exposures were doses 1-3 of the Pfizer, Moderna, AstraZeneca, and Janssen COVID-19 vaccines; outcomes were myocarditis and, as the NCO, otitis externa. The SCRI used a 60-day control window and dose-specific 28-day risk windows, stratified by vaccine brand and adjusted for calendar time. The QBA included two scenarios: (1) baseline probability of the confounder was higher in the control window and (2) vice versa. The NCO was not associated with any of the COVID-19 vaccine types or doses except Moderna dose 1 (IRR = 1.09; 95% CI 1.01-1.09). The QBA suggested that even the strongest literature-reported confounder (COVID-19; RR for myocarditis = 18.3) could only explain away part of the observed effect, from IRR = 3 to IRR = 1.40. The SCRI seems robust to unmeasured confounding in the COVID-19 setting, although a strong unmeasured confounder could bias the observed effect upward. Replication of our findings for other safety signals would strengthen this conclusion. This article is part of a Special Collection on Pharmacoepidemiology.
ISSN:14766256
00029262
DOI:10.1093/aje/kwae172