American Journal of Epidemiology Vol. 143, No. 11: 1165-1173
Copyright © 1996 by The Johns Hopkins University School of Hygiene and Public Health
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Case Series Analysis of Adverse Reactions to Vaccines: A Comparative Evaluation
1PHLS Statistics Unit, Public Health Laboratory Service London NW9 5EQ, England
2Public Health Laboratory, William Harvey Hospital Ashford, Kent TN24 0LZ, England
3Immunization Division, PHLS Communicable Disease Surveillance Centre, Public Health Laboratory Service London NW9 5EQ, England
Reprint requests to Dr. C. P. Famngton, PHLS Statistics Unit, Public Health Laboratory Service, 61 Colindale Avenue, London NW9 5EQ, England.
A modified cohort method has been proposed for estimating the relative incidence of rare adverse reactions after vaccination. The method requires only a sample of the cases, thus avoiding the need for following large population cohorts or selecting controls. This case series method has statistical power equivalent to that of the full cohort method when the risk periods after vaccination are short and vaccine coverage is high. The method also eliminates confounding by variables associated with both the outcome and avoidance of vaccination. In this paper, the cohort, case-control, and case senes methods are reviewed, and their underlying assumptions and performances are compared. Theoretical results are illustrated using data on febnle convulsions after measles-mumps-rubella vaccination in the United Kingdom. Am J Epidemiol 1996; 143: 1165–73.
case-control studies; cohort studies; epidemiologic methods; statistics; vaccination
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