Death Data Exploration

Project Title Death Data Exploration
Date Posted
Thursday, August 17, 2017
Status
Complete
Deliverables
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. 

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 Members

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

Health Outcome
death
Data Sources
Sentinel Distributed Database (SDD)
Related Links