Validation of febrile seizures identified in the Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program |
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| Affiliation: | 1. Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, United States;2. FDA, Center for Drug Evaluation and Research, Silver Spring, MD, United States;3. Division of Allergy-Immunology, The Children’s Hospital of Philadelphia, Philadelphia, PA, United States;4. HealthCore, Alexandria, VA, United States;5. Comprehensive Health Insight, Humana, Louisville, KY, United States;6. Aetna, Blue Bell, PA, United States;7. Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, United States;1. Shandong University, 44 Culture Western Road, Lixia District, Jinan, Shandong Province 250013, China;2. Jinan Municipal Center for Disease Control and Prevention, 2 Weiliu Road, Huaiyin District, Jinan, Shandong Province 250021, China;3. Shandong Center for Disease Control and Prevention, 16992 Qianfo mountain Street Jinan, Lixia District, Jinan, Shandong Province 250014, China;4. Jinan Administrative Committee of International Center for Medical Sciences, Xiyuan building, Huaiyin District, Jinan, Shandong Province, China;1. Johns Hopkins Berman Institute of Bioethics, Johns Hopkins University, USA;2. Department of International Health, Johns Hopkins University Bloomberg School of Public Health, USA;3. Johns Hopkins Center for Immunization Research, Johns Hopkins School of Public Health, USA;4. Institute for Vaccine Safety, Johns Hopkins University Bloomberg School of Public Health, USA;5. Department of Health, Behavior & Society, Johns Hopkins University Bloomberg School of Public Health, USA;6. Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, USA;1. Division of Infectious Diseases, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA;2. Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA;1. School of Biological and Agricultural Engineering, Jilin University, 5988 Renmin Street, Changchun 130022, PR China;2. Key Laboratory of Bionic Engineering, Ministry of Education, Jilin University, 5988 Renmin Street, Changchun 130022, PR China;3. School of Management, Jilin University, 5988 Renmin Street, Changchun 130022, PR China |
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| Abstract: | BackgroundThe Sentinel Initiative was established in 2008 to monitor the safety of FDA-regulated medical products. We evaluated the positive predictive value (PPV) of ICD-9 codes for post-vaccination febrile seizures to identify optimal algorithms for use in post-market safety surveillance.MethodsWe identified ICD-9 diagnosis codes for fever and seizures in the emergency department or inpatient setting after vaccinations of interest from July 1, 2010 to June 30, 2011. Medical record review was conducted to verify febrile seizure events.ResultsOf 216 potential febrile seizures identified with one or more seizure codes (the broadest algorithm), 152 were chart-confirmed (i.e., documentation of fever within 24 h of seizure or clinician diagnosis of febrile seizure; PPV 70%, 95% CI 64, 76%). Two codes specific for febrile seizures produced the highest PPV (PPV 91%, 95% CI 85, 95%) and accounted for 140 confirmed febrile seizures. In the absence of febrile seizure codes, other seizure codes yielded much lower PPVs, regardless of the presence of fever codes.ConclusionsOur results indicate that ICD-9 diagnosis codes in the inpatient and emergency department settings have high predictive value for identifying febrile seizures within the Sentinel Distributed Database. While the PPV of the algorithm based on any diagnosis code for seizure is moderate, the algorithm limited to febrile seizure codes has a high PPV (>90%) and captures the vast majority of confirmed cases identified by the broadest algorithm, suggesting that the narrower algorithm limited to febrile seizure codes may be preferred. |
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| Keywords: | Febrile seizures Algorithm validation Vaccine safety |
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