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Characteristics of Study Design and Elements that may Contribute to the Success of Electronic Safety Monitoring Systems

    Basic Details
    Medical Product
    angiotensin-converting enzyme (ACE) inhibitor
    Health Outcome(s)

    This article describes elements that contribute to the success of electronic safety monitoring systems. Specifically, the authors examine the characteristics of a single drug-outcome pair, for which two large collaborative groups have come to results that have many points in common. Using examples, their goal is to suggest features of a disease problem and data systems that may lead to repeatable findings.

    The article focuses in particular on the association between angiotensin-converting enzyme (ACE) inhibitors and angioedema. The two analytic groups considered are the FDA’s Mini-Sentinel distributed data network and the Observational Medical Outcomes Partnership (OMOP).


    Carlos Bell MPH, Aloka Chakravarty PhD, Susan Gruber PhD, MPH, MS, Susan R. Heckbert, Mark Levenson, David Martin MD, Jennifer C. Nelson PhD, Simone Pinheiro ScD, Bruce M. Psaty MD, PhD, Christian G. Reich MD, PhD, Sebastian Schneeweiss MD, ScD, Azadeh Shoaibi PhD, MS, MHS, Sengwee Toh ScD, Alexander M. Walker MD, PhD

    Corresponding Author

    A. M. Walker, World Health Information Science Consultants, Riverside Center, Suite 2-400, 275 Grove Street, Newton, MA 02466, USA. Email: