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.

Autor:	Bots SH; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands., Belitser S; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands., Groenwold RHH; Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands., Durán CE; Department of Datascience & Biostatistics, Julius Center for Health Sciences and Primary Health. University Medical Center Utrecht, The Netherlands., Riera-Arnau J; Department of Datascience & Biostatistics, Julius Center for Health Sciences and Primary Health. University Medical Center Utrecht, The Netherlands.; Clinical Pharmacology Service, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain., Schultze A; Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK., Messina D; Agenzia Regionale di Sanita', Florence Toscana, Italy., Segundo E; Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain., Douglas I; Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK., Carreras JJ; Vaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO - Public Health)., Garcia-Poza P; Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain., Gini R; Agenzia Regionale di Sanita', Florence Toscana, Italy., Huerta C; Vaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO - Public Health)., Martín-Pérez M; Vaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO - Public Health)., Martin I; Department of Datascience & Biostatistics, Julius Center for Health Sciences and Primary Health. University Medical Center Utrecht, The Netherlands., Paoletti O; Agenzia Regionale di Sanita', Florence Toscana, Italy., Bissacco CA; Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain., Correcher-Martínez E; Vaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO - Public Health)., Souverein P; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands., Urchuequía A; Vaccine Research Department, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO - Public Health)., Villalobos F; Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain., Sturkenboom MCJM; Department of Datascience & Biostatistics, Julius Center for Health Sciences and Primary Health. University Medical Center Utrecht, The Netherlands., Klungel OH; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.
Jazyk:	angličtina
Zdroj:	American journal of epidemiology [Am J Epidemiol] 2024 Jul 03. Date of Electronic Publication: 2024 Jul 03.
DOI:	10.1093/aje/kwae172
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 1 September 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 otitis externa (NCO). 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: (i) baseline probability of the confounder was higher in the control window and (ii) 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 even the strongest literature-reported confounder (COVID-19; RRmyocarditis = 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. (© The Author(s) 2024. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu