DPM researchers developed a study design selection framework to describe methods that may be utilized to evaluate potential associations between vaccines and health outcomes of interest in the Postlicensure Rapid Immunization Safety Monitoring (PRISM) Program and other systems using administrative data.
The PRISM program is the vaccination safety monitoring piece of the FDA’s Mini-Sentinel project, and is the largest cohort in the U.S. general population for vaccine safety surveillance.
The strengths and weaknesses of various designs for vaccine safety monitoring -- including the cohort design, the case-centered design, the risk interval design, the case-control design, the self-controlled risk interval design, the self-controlled case series method, and the case-crossover design, are discussed and summarized in table format. In addition, a structured decision table is offered to help in design selection.
According to lead author and DPM faculty member Meghan Baker, MD, ScD, there is no one best study design for all vaccine-outcome pairs. The most important factors in design choice are the characteristics of the health outcome of interest (abrupt or insidious onset) and the strength of within- and between-person confounding.
To access the abstract published online March 13, 2015 click here.