Alternative Methods for Health Outcomes of Interest Validation

Project Title Alternative Methods for Health Outcomes of Interest Validation
Date Posted
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.

The companion document which presents detailed findings is an Excel spreadsheet. If you do not have Excel, click here to obtain a free version of Microsoft’s Excel Viewer.

If you are using a web page screen reader and are unable to access the Excel document, please contact the Mini-Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to

Workgroup Leader(s)

Glen Schumock PharmD, PhD, MBA; University of Illinois at Chicago, Chicago, IL

Workgroup Members

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