Self controlled case series methods: an alternative to standard epidemiological study designs
Open accessAbstract
The self controlled case series (SCCS) method is an epidemiological study design for which individuals act as their own control—ie, comparisons are made within individuals. Hence, only individuals who have experienced an event are included and all time invariant confounding is eliminated. The temporal association between a transient exposure and an event is estimated. SCCS was originally developed for evaluation of vaccine safety, but has since been applied in a range of settings where exact information on the size of the population at risk is lacking or identification of an appropriate comparison group is difficult—eg, for studies of adverse effects of drug treatments. We provide an overview of the SCCS method, with examples of its use, discuss limitations, assumptions, and potential biases that can arise where assumptions are not met, and provide solutions and examples of good practice.
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We defined a separate preexposure time window, during the control time, as the period of 30 days before treatment initiation and adjusted for it.
“We defined a separate preexposure time window, during the control time, as the period of 30 days before treatment initiation and adjusted for it.”
From Semaglutide and Nonarteritic Anterior Ischemic Optic Neuropathy (2025) · cites this paper as [41]
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References 17 · Cited by 525
- Authors
- Petersen, I., Douglas, I., & Whitaker, H.
- Affiliations
- Aarhus University (DK)
- London School of Hygiene & Tropical Medicine (GB)
- The Open University (GB)
- Corresponding author
- Petersen, Irene
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2016-09-12
- Volume
- 354
- Pages
- i4515
- ISSN
- 1756-1833 (ISSN-L)
- OpenAlex
- W2519433651
- Cited by
- 525
- References
- 17
- Citations by year
- 2026: 33 · 2025: 66 · 2024: 89 · 2023: 78 · 2022: 77 · 2021: 64 · 2020: 49 · 2019: 24 · 2018: 27 · 2017: 15 · 2015: 1 · 2013: 1
- FWCI
- 22.29
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- BMJ (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Open Research Online - ORO (The Open University) (acceptedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Medical Research Council (MR/L009005/1)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- self-controlled case series, vaccine safety, adverse drug reactions, temporal association, study design limitations, bias, causal inference
- MeSH terms
- Humans, Registries, Research Design, Epidemiologic Research Design
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