Death Data Exploration

    Basic Details
    Date Posted
    Thursday, August 17, 2017
    Status
    Complete
    Health Outcome(s)
    death
    Description

    The objective of this workgroup was to determine under which circumstances, if any, could death and cause of death information in the Sentinel Distributed Database be used for safety assessments, with a focus on routine queries. The workgroup will focus on cardiovascular death, a component in major adverse cardiovascular events (MACE), as a use case. The workgroup evaluated the provenance, quality, and “fit for purposeness” of data currently available in the Distributed Database for eventual contribution to medical product safety assessments. The workgroup also assessed epidemiologic issues relating to use of these data, including data lag and degree of missingness. 

    Information
    Data Source(s)
    Sentinel Distributed Database (SDD)
    Workgroup Leader(s)

    Michael Nguyen, MD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Darren Toh, ScD, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Sonal Singh, MD, MPH; Meyers Primary Care Institute, University of Massachusetts Medical School, Worcestor, MA

    Workgroup Member(s)

    Richard Swain, PhD, MPH; David Tyler Coyle, MD, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Susan Andrade, ScD; Kathryn Anzuoni, MPH; Hassan Fouyazi; Leah Goldman, BA; Ben Prince; Joann Wagner, MSW; Meyers Primary Care Institute, University of Massachusetts Medical School, Worcester, MA

    Vinit Nair, BPharm, MS, RPh; Humana, Inc., Miramar, FL

    Mano Selvan, PhD; Comprehensive Health Insights, Humana Inc., Sugar Land, TX

    Yunping Zhou, MS; Humana, Inc., Louisville, KY

    Charles Leonard, PharmD, MSCE; University of Pennsylvania, Philadelphia, PA

    Marie Griffin, MD, MPH; Carlos Grijalva, MD, MPH; Judy King, CCRP; Jea Young Min, PharmD, MPH; Tony Morrow, AS; Christine Whitmore, PhD; Vanderbilt University School of Medicine, Nashville, TN

    Elnara Fazio-Eynullayeva, MA; Andrew Petrone, MPH; Rajani Rajbhandari, BS; Darren Toh, ScD; James Williams, MBA; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA