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Cited by 15Statistical Methods in EpidemiologyPharmacovigilance and Adverse Drug ReactionsStatistical Methods in Clinical Trials

Statistical analysis of MMR vaccine adverse events on aseptic meningitis using the case cross-over design

Park, Taesung, Ki, Moran, Yi, Sung‐Gon·2004·Statistics in Medicine
DOI 10.1002/sim.1540
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Abstract

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.

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Crossref · 10.1002/sim.1540

Cites

21 of 21 references verified0 citation errors · 0 not checkable

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  • In Park 2004 there was a moderate likelihood of selection bias due to missing cases and their records (up to 27%).

    “In Park 2004 there was a moderate likelihood of selection bias due to missing cases and their records (up to 27%).”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Park 2004

  • In Park 2004, the risk of bias was moderate/unknown.

    “Moderate/unknown risk of bias in one study (Park 2004).”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Park 2004

  • In Park 2004, MMR vaccination was positively associated with aseptic meningitis in a cross-over design of 39 participants aged 13 to 29 months, with a Mantel-Haenszel OR of 3.0 (95% CI 1.5 to 6.1).

    “Mantel-Haenszel OR estimate indicates a positive association (3.0; 95% CI 1.5 to 6.1).”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Park 2004

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Authors
Park, T., Ki, M., & Yi, S.
Affiliations
  • Seoul National University (KR)
  • Eulji University (KR)
Corresponding author
Park, Taesung
ORCID
Ki, Moran
Venue
Statistics in Medicine
Publisher
Wiley
Published
2004-05-21
Volume
23
Issue
12
Pages
1871-1883
ISSN
  • 0277-6715 (ISSN-L)
  • 1097-0258
DOI
10.1002/sim.1540
OpenAlex
W2161715571
Cited by
15
References
21
Citations by year
2021: 1 · 2020: 3 · 2016: 1 · 2015: 1 · 2013: 2 · 2012: 1
FWCI
1.01
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Statistics in Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Seoul National University
  • Korea Science and Engineering Foundation
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
MMR vaccine, aseptic meningitis, vaccine adverse events, Monte Carlo simulation, uniformity testing, children, vaccine safety
MeSH terms
Child, Preschool, Data Interpretation, Statistical, Female, Humans, Infant, Korea, Male, Meningitis, Aseptic, Vaccination, Cross-Over Studies, Measles-Mumps-Rubella Vaccine

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