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National Vaccine Program Office
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Proposal Number: | N52 |
PI Name: | Kohl, Katrin S., MD, MPH |
PI Email: | |
PI Title: | Medical Epidemiologist |
Project Title: | Comprehensive evaluation of applicability, reliability, sensitivity and specificity of newly developed standardized case definitions for adverse events following immunization. |
Project Start: | 2003 |
Project End: | 2005 |
Abstract: The primary objective of this research project is to evaluate applicability, reliability, sensitivity, and specificity of standardized case definitions of adverse events following immunization (AEFI) in the United States' passive Vaccine Adverse Event Reporting System (VAERS). Secondary objectives are to: 1) produce a generic protocol for future evaluations in adverse event monitoring systems, and 2) make recommendations regarding improvement of the proposed case definitions for enhanced usefulness in existing surveillance systems, and changes to VAERS to render more meaningful reports for scientific analyses.
Target groups include all researchers of vaccine safety data from clinical trials and surveillance systems, including pharmacovigilance centers, national regulatory agencies, vaccine manufacturers, and clinicians conducting vaccine trials.
Applicability will be tested in VAERS by assessing the proportion of reports with missing criteria to meet the case definition. Reliability will be evaluated by estimating agreement between two persons applying the case definitions to the same VAERS reports. Sensitivity and specificity will be equally evaluated by applying case definitions to a sample of broadly-defined potential cases (those with signs and symptoms suggestive, in any way, of an AEFI), drawn from 100-150 VAERS reports. An expert panel will review the VAERS reports to determine whether the sampled cases are true cases. A comparison will be made between results from the application directly to VAERS data and from the expert panel review.
The expected outcome is the availability of six AEFI case definitions validated in the largest national AEFI monitoring system.
Institution: Centers for Disease Control and Prevention
Date: July 2003
Last revised: February 13, 2009
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