{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T02:58:36Z","timestamp":1785034716116,"version":"3.55.0"},"reference-count":27,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2013,6,25]],"date-time":"2013-06-25T00:00:00Z","timestamp":1372118400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"crossref","award":["HHSF223200910006I"],"award-info":[{"award-number":["HHSF223200910006I"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2013,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD\u20109\u2010CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD\u20109\u2010CM diagnoses in identifying SALI among health plan members in the Mini\u2010Sentinel Distributed Database (MSDD) for patients without liver\/biliary disease and for those with chronic liver disease (CLD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We selected random samples of members (149 without liver\/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD\u20109\u2010CM 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) in the MSDD (2009\u20132010). Medical records were reviewed by hepatologists to confirm SALI events. PPVs of codes and code combinations for confirmed SALI were determined by CLD status.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 105 members with available records and no liver\/biliary disease, SALI was confirmed in 26 (PPV, 24.7%; 95%CI, 16.9\u221234.1%). Combined hospital diagnoses of acute hepatic necrosis (570) and liver disease sequelae (572.8) had high PPV (100%; 95%CI, 59.0\u2013100%) and identified 7\/26 (26.9%) events. Among 46 CLD members with available records, SALI was confirmed in 19 (PPV, 41.3%; 95%CI, 27.0\u201356.8%). Acute hepatic necrosis (570) or hepatorenal syndrome (572.4) plus any other SALI code had a PPV of 83.3% (95%CI, 51.6\u201397.9%) and identified 10\/19 (52.6%) events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Most individual hospital ICD\u20109\u2010CM diagnoses had low PPV for confirmed SALI events. Select code combinations had high PPV but did not capture all events. Copyright \u00a9 2013 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3470","type":"journal-article","created":{"date-parts":[[2013,6,25]],"date-time":"2013-06-25T23:06:56Z","timestamp":1372201616000},"page":"861-872","source":"Crossref","is-referenced-by-count":51,"title":["Validity of diagnostic codes to identify cases of severe acute liver injury in the U.S. Food and Drug Administration's Mini\u2010Sentinel Distributed Database"],"prefix":"10.1002","volume":"22","author":[{"suffix":"III","given":"Vincent","family":"Lo Re","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"},{"name":"Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Haynes","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Goldberg","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"},{"name":"Division of Gastroenterology, Department of Medicine, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly A.","family":"Forde","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"},{"name":"Division of Gastroenterology, Department of Medicine, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dean M.","family":"Carbonari","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly B. F.","family":"Leidl","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Hennessy","sequence":"additional","affiliation":[{"name":"Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. Rajender","family":"Reddy","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Perelman School of Medicine University of Pennsylvania  Philadelphia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamala A.","family":"Pawloski","sequence":"additional","affiliation":[{"name":"HealthPartners Institute for Education and Research  Bloomington MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory W.","family":"Daniel","sequence":"additional","affiliation":[{"name":"HealthCore, Inc.  Wilmington DE USA"},{"name":"Engelberg Center for Health Care Reform The Brookings Institution  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T. Craig","family":"Cheetham","sequence":"additional","affiliation":[{"name":"Pharmacy Analytical Service Kaiser Permanente Southern California  Downey CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aarthi","family":"Iyer","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kara O.","family":"Coughlin","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sengwee","family":"Toh","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise M.","family":"Boudreau","sequence":"additional","affiliation":[{"name":"Group Health Research Institute  Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nandini","family":"Selvam","sequence":"additional","affiliation":[{"name":"HealthCore, Inc.  Wilmington DE USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William O.","family":"Cooper","sequence":"additional","affiliation":[{"name":"Vanderbilt University School of Medicine  Nashville TN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mano S.","family":"Selvan","sequence":"additional","affiliation":[{"name":"Competitive Health Analytics Humana Inc.  Louisville KY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey J.","family":"VanWormer","sequence":"additional","affiliation":[{"name":"Marshfield Clinic Research Foundation  Marshfield WI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark I.","family":"Avigan","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Houstoun","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gwen L.","family":"Zornberg","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith A.","family":"Racoosin","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azadeh","family":"Shoaibi","sequence":"additional","affiliation":[{"name":"U.S. Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,6,25]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"PhRMA\/FDA\/AASLD drug\u2010induced hepatotoxicity white paper postmarketing considerations. 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