Sentinel Medical Chart Review Gap Analysis

    Basic Details
    Date Posted
    Wednesday, April 18, 2018
    Status
    Complete
    Description

    The Food and Drug Administration (FDA)’s Sentinel Initiative captures and curates electronic healthcare data from health insurers and re-purposes these data to answer regulatory questions. Selective medical chart review is important to assess the performance of claims-based algorithms for identifying conditions of interest, and to validate specific individuals’ exposures and/or health outcomes of interest. The purpose of this project was to assess the Sentinel Initiative’s chart review processes to: 1) identify the major drivers of time and cost needed for completion, 2) describe improvements that have been implemented, and 3) propose recommendations to re-engineer the process to reduce the overall cost, time, and effort needed to complete medical chart reviews.

    Information
    HOI Study Type
    Novel Approaches to More Efficient Outcome Validation
    Workgroup Leader(s)

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

    Workgroup Member(s)

    Carolyn Balsbaugh, MPH; Sandra Feibelmann, MPH;  Meighan Rogers Driscoll, MPH; Susan Forrow, BA; Crystal Garcia, MPH; Alison Kawai, ScD; Adee Kennedy, MS, MPH; Hana Lipowicz, MPH; Ella Pestine, MPH; Richard Platt, MD; Meghan Reidy, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Michael Nguyen, MD; Office of Surveillance and Epidemiology, Center for Drug and Evaluation Research, FDA, Silver Spring, MD