Details
The objective of this study was to explore the FDA Sentinel System’s ability to conduct real-world evidence evaluations for the pediatric population, with a focus on identifying and comparing clinically-defined and claims-based pediatric hypertensive patients within the Sentinel System.
Given concerns about the potential under-capture of pediatric hypertension in claims-based data observed in the initial analysis, the study further explored the use of blood pressure measures for identifying hypertension in the pediatric population. The follow-up analysis compared and examined overlap between the two methods for identification of pediatric hypertensive patients (claims-based and clinical electronic health record [EHR]-based) over a 36-month period in the Sentinel System. Findings indicated poor concurrence between claims and clinical definitions of hypertension. Pediatric hypertension is under-captured in claims-based data sources but can serve as a marker for greater disease severity.
This study provided FDA with insights into the differences in how pediatric hypertension is captured across different real-world-data (RWD) sources, which could support the planning of future pediatric hypertension studies.