Purpose: Understanding the completeness and accuracy of U.S. military anthrax vaccination data is important to the design and interpretation of studies to assess the safety of anthrax vaccine. We estimated the agreement between electronically recorded anthrax vaccination data in the Defense Medical Surveillance System (DMSS) versus anthrax vaccination data abstracted from hardcopy medical charts in a representative sample of the U.S. military from 1998 to 2004.
Methods: Medical chart abstractions were conducted at 28 military treatment facilities for 4201 personnel. Abstracted anthrax vaccination data for 1817 personnel, representing 7400 anthrax vaccine doses, were compared with electronically captured data in the DMSS from 1998 to 2004. Sensitivity, positive predictive value (PPV), specificity and negative predictive value (NPV) were calculated using weighted analyses.
Results: Weighted person-level analysis revealed DMSS sensitivity = 93.8% (95%CI = 91.1, 95.8), specificity = 87.0% (79.0, 92.3), PPV = 85.6% (77.2, 91.3) and NPV = 94.5% (91.7, 96.4). Report of anthrax vaccination within a +/-7 days window in both medical chart and DMSS electronic data had a sensitivity of 88.3% (85.4, 90.7) and a PPV of 86.6% (84.9, 88.2) in the vaccine dose-level analysis.
Conclusions: These results support that anthrax vaccination data captured by the DMSS are adequate for post-marketing surveillance investigations in the U.S. military and are of comparable quality to data captured by other vaccine safety databases.
Copyright (c) 2007 John Wiley & Sons, Ltd.