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