The methodology of self-controlled case series studies.
The self-controlled case series method is increasingly being used in pharmacoepidemiology, particularly in vaccine safety studies. This method is typically used to evaluate the association between a transient exposure and an acute event, using only cases. We present both parametric and semiparametric models using a motivating example on MMR vaccine and bleeding disorders. We briefly describe approaches for interferent events and a sequential version of the method for prospective surveillance of drug safety. The efficiency of the self-controlled case series method is compared to the that of cohort and case control studies. Some further extensions, to long or indefinite exposures and to bivariate counts, are described.
Department of Mathematics and Statistics, The Open University, Milton Keynes, MK7 6AA, UK. h.j.whitaker@open.ac.uk
Heather J
HJ
Whitaker
Mounia N
MN
Hocine
C Paddy
CP
Farrington
D001699:Biometry / Q000379:methods*; D006509:Hepatitis B / Q000276:immunology; D006801:Humans; D016013:Likelihood Functions; D022542:Measles-Mumps-Rubella Vaccine / Q000009:adverse effects; D015233:Models, Statistical; D017891:Pharmacoepidemiology / Q000379:methods*; D012107:Research Design; D013920:Thrombocythemia, Essential / Q000139:chemically induced
D022542:Measles-Mumps-Rubella Vaccine