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

Authors: Rudan, Igor ;

Katikireddi, Srinivasa Vittal ;

Kerr, Steven ;

Millington, Tristan;

Grange, Zoe;

Sullivan, Christopher;

Fagbamigbe, Adeniyi F. ;

Swallow, Ben ;

Kurdi, Amanj ;

Morrison, Kirsty ;

Jeffrey, Karen;

Simpson, Colin R ;

Robertson, Chris;

Ritchie, Lewis D.;

Sheikh, Aziz

Source: Journal of Global Health

Full text

: https://doi.org/10.7189/jogh.14.03037

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.

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Cite as

Rudan, I., Katikireddi, S., Kerr, S., Millington, T., Grange, Z., Sullivan, C., Fagbamigbe, A., Swallow, B., Kurdi, A., Morrison, K., Jeffrey, K., Simpson, C., Robertson, C., Ritchie, L. & Sheikh, A. 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, article no: 03037. https://doi.org/10.7189/jogh.14.03037

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DOI: https://doi.org/10.7189/jogh.14.03037

Repository URI: https://strathprints.strath.ac.uk/90189/