Selecting the most informative positive and negative controls for self-controlled case series (SCCS) : rationale, approach, and lessons from studies investigating the safety of COVID-19 vaccines

Rudan, Igor and Katikireddi, Srinivasa Vittal and Kerr, Steven and Millington, Tristan and Grange, Zoe and Sullivan, Christopher and Fagbamigbe, Adeniyi Francis and Swallow, Ben and Kurdi, Amanj and Morrison, Kirsty and Jeffrey, Karen and Simpson, Colin R and Ritchie, Sir Lewis and Robertson, Chris and Sheikh, Sir Aziz (2024) Selecting the most informative positive and negative controls for self-controlled case series (SCCS) : rationale, approach, and lessons from studies investigating the safety of COVID-19 vaccines. Journal of Global Health, 14. 03037. ISSN 2047-2978 (https://doi.org/10.7189/jogh.14.03037)

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Abstract

The self-controlled case series (SCCS) is a study design used in epidemiology to test for variation in outcomes for a group of individuals before and after an exposure or intervention, with each pre-intervention individual serving as a control for themselves in the post-intervention period. The design is particularly useful for studying rare events or outcomes that occur in a time-dependent manner, such as uncommon side-effects of a medical intervention [1–3]. In the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) study, we used this SCCS design to evaluate the safety of coronavirus disease 2019 (COVID-19) vaccines in various age groups of the Scottish and UK populations.

ORCID iDs

Rudan, Igor, Katikireddi, Srinivasa Vittal, Kerr, Steven, Millington, Tristan, Grange, Zoe, Sullivan, Christopher, Fagbamigbe, Adeniyi Francis, Swallow, Ben, Kurdi, Amanj ORCID logoORCID: https://orcid.org/0000-0001-5036-1988, Morrison, Kirsty, Jeffrey, Karen, Simpson, Colin R, Ritchie, Sir Lewis, Robertson, Chris and Sheikh, Sir Aziz;
CORE (COnnecting REpositories)