15 Cohorts of Interest for Surveillance Preparedness

Project Title 15 Cohorts of Interest for Surveillance Preparedness
Date Posted
Wednesday, May 7, 2014
Status
Complete
Deliverables
Description

This report describes 1) a review of the literature concerning algorithms for identifying specified cohorts in which exposure to medical countermeasures will more likely result in adverse outcomes, and 2) recommends algorithms to identify these cohorts for use in future surveillance activities. The report focuses on algorithms for 15 cohorts identified by FDA as relevant to medical countermeasures for use with Mini-Sentinel Prospective Routine Observational Monitoring Program Tools (PROMPT).

The Addendum provides detailed information concerning algorithms identified in the literature review. This document 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 this document, please contact the Sentinel Operations Center for assistance by clicking on the Submit Comments link above or sending an email requesting assistance to info@sentinelsystem.org.

Workgroup Leader(s)

Charles E. Leonard PharmD, MSCE; Center for Clinical Epidemiology and Biostatistics, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Workgroup Members

Cristin P. Freeman MPH, MBE; Hanieh Razzaghi MPH; Center for Clinical Epidemiology and Biostatistics, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Ryan M. Carnahan PharmD, MS, BCPP; Elizabeth A. Chrischilles PhD, MS; Department of Epidemiology, College of Public Health, The University of Iowa, Iowa City, IA

Susan E. Andrade ScD; Meyers Primary Care Institute, a joint endeavor of Fallon Community Health Plan, Reliant Medical Group, and University of Massachusetts Medical School, Worcester, MA

Allison Naleway PhD; The Center for Health Research Northwest, Kaiser Permanente, Portland, OR

Robert Penfold PhD; Group Health Research Institute, Seattle, WA

Gregory E. Simon MD, MPH; Group Health Research Institute and Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA

Patrick Archdeacon MD; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Springs, MD

Faith Barash MD, MPH, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Monika Houstoun PharmD, BCPS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

David Menschik MD, MPH; Division of Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD