Design for validation of acute myocardial infarction cases in Mini-Sentinel

Author:

Cutrona Sarah L.1,Toh Sengwee2,Iyer Aarthi2,Foy Sarah1,Cavagnaro Elizabeth2,Forrow Susan2,Racoosin Judith A.3,Goldberg Robert1,Gurwitz Jerry H.1

Affiliation:

1. Fallon Community Health Plan and Fallon Clinic, Meyers Primary Care Institute; University of Massachusetts Medical School; Worcester MA USA

2. Department of Population Medicine; Harvard Medical School and Harvard Pilgrim Health Care Institute; Boston MA USA

3. Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring MD USA

Funder

FDA through the Department of Health and Human Services

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference26 articles.

1. Developing the Sentinel System - A National Resource for Evidence Development;Behrman;N Engl J Med,2011

2. The Sentinel Initiative: Access to Electronic Healthcare Data for More than 25 Million Lives; Achieving FDAAA Section 905 Goal One 2010 http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM233360.pdf

3. The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program;Forrow;Pharmacoepidemiol Drug Saf,2012

4. Design considerations, architecture, and use of the Mini-Sentinel distributed data system;Curtis;Pharmacoepidemiol Drug Saf,2012

5. Cutrona SL Toh D Iyer A et al Mini-Sentinel Systematic Validation of Health Outcome of Interest Acute Myocardial Infarction Cases Report http://mini-sentinel.org/work_products/Validation_HealthOutcomes/Mini-Sentinel-Validation-of-AMI-Cases.pdf

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