Tutorial in biostatistics: the self‐controlled case series method
Open accessAbstract
The self‐controlled case series method was developed to investigate associations between acute outcomes and transient exposures, using only data on cases, that is, on individuals who have experienced the outcome of interest. Inference is within individuals, and hence fixed covariates effects are implicitly controlled for within a proportional incidence framework. We describe the origins, assumptions, limitations, and uses of the method. The rationale for the model and the derivation of the likelihood are explained in detail using a worked example on vaccine safety. Code for fitting the model in the statistical package STATA is described. Two further vaccine safety data sets are used to illustrate a range of modelling issues and extensions of the basic model. Some brief pointers on the design of case series studies are provided. The data sets, STATA code, and further implementation details in SAS, GENSTAT and GLIM are available from an associated website. Copyright © 2005 John Wiley & Sons, Ltd.
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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 [40]
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- Authors
- Whitaker, H. J., Paddy Farrington, C., Spiessens, B., & Musonda, P.
- Affiliations
- The Open University (GB)
- GlaxoSmithKline (Belgium) (BE)
- Corresponding author
- Whitaker, Heather J.
- Venue
- Statistics in Medicine
- Publisher
- Wiley
- Published
- 2005-10-11
- Volume
- 25
- Issue
- 10
- Pages
- 1768-1797
- ISSN
- 0277-6715 (ISSN-L)
- 1097-0258
- OpenAlex
- W2058837954
- Cited by
- 719
- References
- 2
- Citations by year
- 2026: 31 · 2025: 38 · 2024: 54 · 2023: 46 · 2022: 50 · 2021: 53 · 2020: 41 · 2019: 34 · 2018: 34 · 2017: 40 · 2016: 40 · 2015: 37 · 2014: 39 · 2013: 52 · 2012: 42
- FWCI
- 9.34
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Statistics in Medicine (publishedVersion)
- PubMed (publishedVersion)
- Open Research Online - ORO (The Open University) (submittedVersion)
- UEA Digital Repository (University of East Anglia) (submittedVersion)
- Funders
- Wellcome Trust (070346, WT070346)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- self-controlled case series, acute outcomes, transient exposure, vaccine safety, Stata implementation
- MeSH terms
- Biometry, Child, Preschool, Data Interpretation, Statistical, Humans, Infant, Intussusception, Meningitis, Viral, Models, Biological, Poliovirus Vaccine, Oral, Purpura, Thrombocytopenic, Risk, Vaccination, Models, Statistical, Measles-Mumps-Rubella Vaccine
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