|Project Title||Alternative Methods for Health Outcomes of Interest Validation|
Wednesday, September 25, 2013
This report summarizes alternative methods for validating selected health outcomes of interest (HOIs), which included linkage to registries and external data sources, as compared to chart validation. The project explored methods that are less costly and time consuming than medical chart review, which has been the standard method for HOI algorithm validation. The HOIs were selected based on the dearth of validated algorithms with high performance characteristics in the existing literature, and prioritization by FDA. They were rated as feasible, potentially feasible, or unlikely/not feasible for linkage based on the availability and accessibility of alternate data sources, cost of linking these data sources to the Mini-Sentinel Distributed Database (MSDD), and the extent of overlap of these databases with the MSDD.
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Glen Schumock PharmD, PhD, MBA; University of Illinois at Chicago, Chicago, IL
Todd Lee PharmD, PhD; Simon Pickard PhD; Wan-Ju Lee BPharm, MS; Hari Patel PharmD; Priyameth Dilokthornsakul PharmD; University of Illinois at Chicago, Chicago, IL
Azadeh Shoaibi MS, MHS and Patrick Archdeacon MD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
- Vaccines, Blood & Biologics
- Devices and Radiologic Health