The self-controlled case series method (SCCSM) is a novel study design to investigate associations between acute responses with transient point exposures (for example vaccination). The method provides an attractive alternative to cohort and case-control designs. The method is unusual in that it requires data only on individuals who experience a response (the ‘cases’). The data are then analysed using a Poisson model, conditional on the total number of events occurring for each individual. This conditioning ensures that including only cases does not bias the relative risk estimator. The self- controlled case series method has been used to good effect in many settings, such as MMR vaccine and autism, oral polio vaccine and intussusception, MMR vaccine and idiopathic thrombocytopenic purpura, influenza vaccine and asthma exacerbations. However, hitherto, limited research had been undertaken on the statistical properties of the method in general, and virtually no work had been undertaken on design issues. All these issues were explored and consolidated by analysing data on intussusception and oral polio vaccine from GlaxoSmithKline (GSK).

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