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

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

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 final report will be prepared with the results from the two use cases. Additionally, a comparison of the identification using a claims-only phenotype versus a clinical data (e.g., electronic health record based) phenotype will be conducted.

Link
Published Date
Thursday, July 30, 2020
Category
Ongoing Projects
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