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Validity of Diagnostic Codes to Identify Cases of Severe Acute Liver Injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database

    Basic Details
    Health Outcome(s)
    chronic liver disease
    severe acute liver injury (SALI)

    This article describes a Mini-Sentinel project to validate an algorithm based on International Classification of Diseases, Ninth revision, Clinical Modification (ICD-9-CM) codes for severe acute liver injury (SALI) among health plan members in the Mini-Sentinel Distributed Database (MSDD) for patients without liver/biliary disease and for those with chronic liver disease (CLD), using medical record review.

    Time Period
    January 1, 2009 - December 31, 2010
    Data Source(s)
    Mini-Sentinel Distributed Database (MSDD)

    Vincent Lo Re MD, MSCE; Kevin Haynes PharmD, MSCE; David Goldberg MD, MSCE; Kimberly L. Forde MD, MHS; Dena M. Carbonari MS; Kimberly B. F. Leidi MPH; Sean Hennessy PharmD, PhD; K. Rajender Reddy MD; Pamela A. Pawloski PharmD; Gregory W. Daniel PhD, MPH, RPh; Craig Cheetham PharmD, MS; Aarthi Iyer MPH; Kara O. Coughlin; Sengwee Toh ScD, Denise M. Boudreau RPh, PhD; Nandani Selvam PhD, MPH; William O. Cooper MD, MPH; Mano S. Selvan PhD; Jeffery J. VanWormer PhD; Mark I. Avigan MD, CM; Monika Houstoun PharmD; Gwen L. Zornberg MD, ScD, MS; Judith A. Racoosin MD, MPH; Azadeh Shoaibi PhD, MHS, MS

    Corresponding Author

    V. L. Re III, MD, MSCE, Center for Clinical Epidemiology and Biostatistics, 836 Blockley Hall, 423 Guardian Drive, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104-6021, USA. Email: