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

    Basic Details
    Date Posted
    Thursday, July 30, 2020
    Status
    In progress
    Health Outcome(s)
    SGLT-2
    hypertension
    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 comparison of the identification using a claims-only phenotype versus a clinical data (e.g., electronic health record based) phenotype will be conducted. A final report with results has been posted from the first use case that evaluated a cohort of pediatric patients with hypertension. The second use case is still in progress and a final report will be posted when complete.

    Information
    Population / Cohort
    Pediatric patients with hypertension; new adult users of SGLT-2 inhibitors
    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 Member(s)

    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

    Efe Eworuke, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD