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Statistical analysis of MMR vaccine adverse events on aseptic meningitis using the case cross‐over design
Author(s) -
Park Taesung,
Ki Moran,
Yi SungGon
Publication year - 2004
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.1540
Subject(s) - medicine , aseptic meningitis , adverse effect , vaccination , poisson regression , measles , incidence (geometry) , pediatrics , meningitis , immunology , environmental health , mathematics , population , geometry
Vaccination is quite effective in reducing the incidence of disease. However, it may cause some adverse events. For example, one of the adverse events of measles‐mumps‐rubella(MMR) vaccination is the occurrence of aseptic meningitis. Since the vaccination rate is usually quite high, it is not plausible to use popular study designs such as cohort or case‐control studies. We considered a case cross‐over design to investigate the association between MMR vaccination and aseptic meningitis in Korean children. We used the Cochran–Mantel–Haenszel(CMH) approach, and obtained a Mantel–Haenszel odds ratio estimator as a measure of association. However, the validity of case cross‐over design or the CMH approach in vaccine adverse studies has not been fully investigated. In this paper, through Monte Carlo simulation studies, we show the appropriateness of the case cross‐over design and the CMH approach. We also discuss alternative approaches such as Poisson regression using offset and a simple uniformity test. In conclusion, the case cross‐over design seems useful to investigate the association between vaccination and occurrence of acute adverse events. Copyright © 2004 John Wiley & Sons, Ltd.