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Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 3

    Basic Details
    Date Posted

    This report describes the activity of the Mini-Sentinel Year 3 Taxonomy workgroup, including development of a Taxonomy Selection Tool that guides users to recommended Mini-Sentinel Prospective Routine Observational Monitoring Program Tool (PROMPT) methods to perform rapid semi-automated monitoring of a given medical product-outcome pair within Mini-Sentinel. The Taxonomy PROMPT Selection Tool is an interactive Excel spreadsheet that considers the number of comparator groups, characteristics of the exposure of interest (e.g., whether it is acute or sustained) and the likelihood of potential biases, such as within-person confounding, between-person confounding, exposure misclassification, and outcome misclassification when selecting the most appropriate PROMPT. In addition, the report describes current gaps in the PROMPT methods and makes recommendations for future development activities.

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    Workgroup Leader(s)

    Joshua Gagne, PharmD, ScD; Department of Pharmocoecoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

    Workgroup Member(s)

    Meghan Baker, MD, ScD; Alison Tse Kawai, ScD, SM; Katherine Yih, PhD, MPH; Grace Lee, MD, MPH; Sunali Goonesekera, SM; Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA 

    Katsiaryna Bykov, PharmD, MS; Sebastian Schneeweiss, MD, ScD; Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

    Azadeh Shoaibi, MS, MHS; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD