TY  - JOUR
AU  - Deady, Matthew
AU  - Duncan, Raymond
AU  - Sonesen, Matthew
AU  - Estiandan, Renier
AU  - Stimpert, Kelly
AU  - Cho, Sylvia
AU  - Beers, Jeffrey
AU  - Goodness, Brian
AU  - Jones, Lance Daniel
AU  - Forshee, Richard
AU  - Anderson, Steven A
AU  - Ezzeldin, Hussein
PY  - 2024
DA  - 2024/11/25
TI  - A Computable Phenotype Algorithm for Postvaccination Myocarditis/Pericarditis Detection Using Real-World Data: Validation Study
JO  - J Med Internet Res
SP  - e54597
VL  - 26
KW  - adverse event
KW  - vaccine safety
KW  - interoperability
KW  - computable phenotype
KW  - postmarket surveillance system
KW  - fast healthcare interoperability resources
KW  - FHIR
KW  - real-world data
KW  - validation study
KW  - Food and Drug Administration
KW  - electronic health records
KW  - COVID-19 vaccine
AB  - Background: Adverse events (AEs) associated with vaccination have traditionally been evaluated by epidemiological studies. More recently, they have gained attention due to the emergency use authorization of several COVID-19 vaccines. As part of its responsibility to conduct postmarket surveillance, the US Food and Drug Administration continues to monitor several AEs of interest to ensure the safety of vaccines, including those for COVID-19. Objective: This study is part of the Biologics Effectiveness and Safety Initiative, which aims to improve the US Food and Drug Administration’s postmarket surveillance capabilities while minimizing the burden of collecting clinical data on suspected postvaccination AEs. The objective of this study was to enhance active surveillance efforts through a pilot platform that can receive automatically reported AE cases through a health care data exchange. Methods: We detected cases by sharing and applying computable phenotype algorithms to real-world data in health care providers’ electronic health records databases. Using the fast healthcare interoperability resources standard for secure data transmission, we implemented a computable phenotype algorithm on a new health care system. The study focused on the algorithm's positive predictive value, validated through clinical records, assessing both the time required for implementation and the accuracy of AE detection. Results: The algorithm required 200-250 hours to implement and optimize. Of the 6,574,420 clinical encounters across 694,151 patients, 30 cases were identified as potential myocarditis/pericarditis. Of these, 26 cases were retrievable, and 24 underwent clinical validation. In total, 14 cases were confirmed as definite or probable myocarditis/pericarditis, yielding a positive predictive value of 58.3% (95% CI 37.3%-76.9%). These findings underscore the algorithm's capability for real-time detection of AEs, though they also highlight variability in performance across different health care systems. Conclusions: The study advocates for the ongoing refinement and application of distributed computable phenotype algorithms to enhance AE detection capabilities. These tools are crucial for comprehensive postmarket surveillance and improved vaccine safety monitoring. The outcomes suggest the need for further optimization to achieve more consistent results across diverse health care settings. 
SN  - 1438-8871
UR  - https://www.jmir.org/2024/1/e54597
UR  - https://doi.org/10.2196/54597
DO  - 10.2196/54597
ID  - info:doi/10.2196/54597
ER  -