|Project Title||Mini-Sentinel: 15 Cohorts of Interest for Surveillance Preparedness|
Wednesday, May 7, 2014
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.
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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
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
- Vaccines, Blood & Biologics
- Devices and Radiologic Health