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
Date Posted
Thursday, July 30, 2020
Status
In progress
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.

Workgroup Leader(s)

Judith C. Maro, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Danijela Stojanovic, PharmD, PhD; Brian Kit, MD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Members

Jennifer Lyons, PhD; Nicole Haug, MPH; Casie Horgan, MPH; Jillian Burk, MPH; Soowoo Back, MPH; Meredith Cantwell, MScPH; Alex Peters, MPH; Sandra DeLuccia, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Health Outcome
SGLT-2
hypertension
Population / Cohort
Pediatric patients with hypertension; new adult users of SGLT-2 inhibitors
Scroll to Top