|Project Title||Sentinel Medical Chart Review Gap Analysis|
Wednesday, April 18, 2018
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.
Judith Maro PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
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
- Vaccines, Blood & Biologics
- Devices and Radiologic Health