Faculty Collaboration Database

Four different study designs to evaluate vaccine safety were equally validated with contrasting limitations. J Clin Epidemiol 2006 Aug;59(8):808-18

Date

07/11/2006

Pubmed ID

16828674

DOI

10.1016/j.jclinepi.2005.11.012

Scopus ID

2-s2.0-33745699070 (requires institutional sign-in at Scopus site)   87 Citations

Abstract

OBJECTIVE: We conducted a simulation study to empirically compare four study designs [cohort, case-control, risk-interval, self-controlled case series (SCCS)] used to assess vaccine safety.

STUDY DESIGN AND METHODS: Using Vaccine Safety Datalink data (a Centers for Disease Control and Prevention-funded project), we simulated 250 case sets of an acute illness within a cohort of vaccinated and unvaccinated children. We constructed the other three study designs from the cohort at three different incident rate ratios (IRRs, 2.00, 3.00, and 4.00), 15 levels of decreasing disease incidence, and two confounding levels (20%, 40%) for both fixed and seasonal confounding. Each of the design-specific study samples was analyzed with a regression model. The design-specific beta; estimates were compared.

RESULTS: The beta; estimates of the case-control, risk-interval, and SCCS designs were within 5% of the true risk parameters or cohort estimates. However, the case-control's estimates were less precise, less powerful, and biased by fixed confounding. The estimates of SCCS and risk-interval designs were biased by unadjusted seasonal confounding.

CONCLUSIONS: All the methods were valid designs, with contrasting strengths and weaknesses. In particular, the SCCS method proved to be an efficient and valid alternative to the cohort method.

Author List

Glanz JM, McClure DL, Xu S, Hambidge SJ, Lee M, Kolczak MS, Kleinman K, Mullooly JP, France EK

Author

David L. McClure PhD Adjunct Assistant Professor in the Institute for Health and Equity department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Acute Disease
Adolescent
Bias
Case-Control Studies
Child
Child, Preschool
Cohort Studies
Female
Health Services Research
Humans
Male
Measles-Mumps-Rubella Vaccine
Models, Theoretical
Reproducibility of Results
Research Design
Time Factors