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Use of the self-controlled case series method in vaccine safety studies: review and recommendations for best practice

Weldeselassie, Yonas; Whitaker, Heather and Farrington, Paddy (2011). Use of the self-controlled case series method in vaccine safety studies: review and recommendations for best practice. Epidemiology and Infection, 139 pp. 1805–1817.

DOI (Digital Object Identifier) Link: http://dx.doi.org/10.1017/S0950268811001531
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Abstract

The self-controlled case-series method was originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose. This study reviews applications of the method to vaccine safety investigations in the period 1995–2010. In total, 40 studies were reviewed. The application of the self-controlled case-series method in these studies is critically examined, with particular reference to the definition of observation and risk periods, control of confounders, assumptions and potential biases, methodological and presentation issues, power and sample size, and software. Comparisons with other study designs undertaken in the papers reviewed are also highlighted. Some recommendations are presented, with the emphasis on promoting good practice.

Item Type: Journal Article
Copyright Holders: 2011 Cambridge University Press
Keywords: epidemiology; statistics; vaccine safety
Academic Unit/Department: Mathematics, Computing and Technology > Mathematics and Statistics
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Item ID: 30434
Depositing User: Paddy Farrington
Date Deposited: 09 Dec 2011 09:08
Last Modified: 03 Dec 2012 12:09
URI: http://oro.open.ac.uk/id/eprint/30434
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