Epidemiology and Infection

Methods and modelling

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

Y. G. WELDESELASSIEa1, H. J. WHITAKERa1 and C. P. FARRINGTONa1 c1

a1 Department of Mathematics and Statistics, The Open University, Milton Keynes, UK

SUMMARY

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.

(Accepted July 18 2011)

(Online publication August 18 2011)

Correspondence:

c1 Author for correspondence: Professor C. P. Farrington, Department of Mathematics and Statistics, MCT Faculty, The Open University, Walton Hall, Milton Keynes MK7 6AA, UK. (Email: c.p.farrington@open.ac.uk)

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