title: Epidemiological designs for vaccine safety assessment: methods and pitfalls.
abstract: Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues.
authors: Statistics Modelling and Economics Department, Health Protection Services, Health Protection Agency, 61 Colindale Avenue, London, NW9 5EQ, UK. nick.andrews@hpa.org.uk
authors: Nick
authors: N
authors: Andrews
mesh_terms: D001321:Autistic Disorder / Q000453:epidemiology / Q000209:etiology; D016022:Case-Control Studies; D015331:Cohort Studies; D003625:Data Collection; D015340:Epidemiologic Research Design; D016021:Epidemiologic Studies; D006801:Humans; D022542:Measles-Mumps-Rubella Vaccine / Q000009:adverse effects / Q000627:therapeutic use; D061214:Patient Safety / Q000706:statistics & numerical data*; D012042:Registries / Q000706:statistics & numerical data; D012107:Research Design; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D022542:Measles-Mumps-Rubella Vaccine; D014612:Vaccines