Pilot Test of Vital Signs and Laboratory Results Table Descriptive Modules in the Sentinel Distributed Database

The proposed goal of this project is to pilot, via two use cases, the ability to more routinely and broadly understand how FDA might conduct “on-demand quality assurance” for selected vital signs and laboratory results in a within cohort fashion. The first use case will evaluate a cohort of pediatric patients with hypertension. The second use case will evaluate a cohort of new adult users of SGLT-2 inhibitors.

Vital signs and laboratory measures will be evaluated for each use case. Measures will include blood pressure as well as smoking use/status, height, and weight. Laboratory tests will include Hemoglobin A1c and creatinine.

A comparison of the identification using a claims-only phenotype versus a clinical data (e.g., electronic health record based) phenotype will be conducted. Two reports have been posted from the first use case that evaluated a cohort of pediatric patients with hypertension. In the first report, the hypertension algorithm is simplified. The second report utilized a more complex hypertension algorithm to define events of interest. The second use case is still in progress and a final report will be posted when complete.