In order to identify rare vaccine adverse events, the CDC funded the Vaccine Safety Datalink (VSD), a large database that brings together computerized information on immunizations, medical outcomes and potential confounders.
VACCINE SAFETY DATALINK: A
SPECIAL PURPOSE DATABASE
In
order to identify rare vaccine adverse events, the CDC funded the Vaccine
Safety Datalink (VSD), a large database that brings together computerized
information on immunizations, medical outcomes and potential confounders. The
VSD has been used to evaluate hypotheses from the medical literature, from the
VAERS, from changes in immunization schedules, and from the introduction of new
vaccines. Beginning in 1991, CDC joined with four HMOs, GHC, KPNW, Kaiser
Permanente Northern California and Kaiser Permanente Southern California, all
in the western part of the United States. Up to ten HMOs have been utilized for
specific studies (DeStefano, 2001), capitalizing on the efficiencies offered by
HMOs for population-based health research. Initially focusing on children up to
6 years of age, the database now includes adolescents and adults as well, and
totals to approximately 6 million members (DeStefano, 2001). Information on all
vaccinations given within the HMO study population, either routinely or for
special indications, is computerized, including the vaccine type, date of
vaccination, concurrent vaccinations, the manufacturer and lot number and site
of vaccination. Outcome data are collected from various sources at each site,
such as hospitalizations, emergency depart-ment visits and outpatient clinic
visits. To preserve patient confidentiality, each site assigns unique study
identifiers to its data before shipping to the CDC annually for merging and
analysis (Chen et al., 1997).
Quality
control studies have shown high levels of agreement between computerized data
and paper medical records. A quality control analysis of three of the HMOs
comparing the automated database with paper records for common childhood
vaccines showed that from 83% to 99% of the automated records were present in
the paper records, and from 82% to 98% of the paper records were present in the
automated database (Mullooly et al.,
1999).
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