Validity of diagnostic codes to identify cases of severe acute liver injury in the US Food and Drug Administration's Mini-Sentinel Distributed Database

Pharmacoepidemiol Drug Saf. 2013 Aug;22(8):861-72. doi: 10.1002/pds.3470. Epub 2013 Jun 25.

Abstract

Purpose: The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD-9-CM diagnoses in identifying 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).

Methods: We selected random samples of members (149 without liver/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD-9-CM 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) in the MSDD (2009-2010). Medical records were reviewed by hepatologists to confirm SALI events. PPVs of codes and code combinations for confirmed SALI were determined by CLD status.

Results: Among 105 members with available records and no liver/biliary disease, SALI was confirmed in 26 (PPV, 24.7%; 95%CI, 16.9-34.1%). Combined hospital diagnoses of acute hepatic necrosis (570) and liver disease sequelae (572.8) had high PPV (100%; 95%CI, 59.0-100%) and identified 7/26 (26.9%) events. Among 46 CLD members with available records, SALI was confirmed in 19 (PPV, 41.3%; 95%CI, 27.0-56.8%). Acute hepatic necrosis (570) or hepatorenal syndrome (572.4) plus any other SALI code had a PPV of 83.3% (95%CI, 51.6-97.9%) and identified 10/19 (52.6%) events.

Conclusions: Most individual hospital ICD-9-CM diagnoses had low PPV for confirmed SALI events. Select code combinations had high PPV but did not capture all events.

Keywords: ICD-9 codes; hepatotoxicity; liver injury; pharmacoepidemiology; validity.

Publication types

  • Research Support, U.S. Gov't, P.H.S.
  • Validation Study

MeSH terms

  • Acute Disease
  • Aged
  • Aged, 80 and over
  • Chemical and Drug Induced Liver Injury / diagnosis
  • Chemical and Drug Induced Liver Injury / epidemiology*
  • Chemical and Drug Induced Liver Injury / physiopathology
  • Chronic Disease
  • Clinical Coding*
  • Cross-Sectional Studies
  • Databases, Factual / statistics & numerical data
  • Female
  • Humans
  • International Classification of Diseases*
  • Liver Diseases / diagnosis
  • Liver Diseases / epidemiology*
  • Liver Diseases / physiopathology
  • Male
  • Medical Records / statistics & numerical data
  • Middle Aged
  • Pharmacoepidemiology
  • Predictive Value of Tests
  • Product Surveillance, Postmarketing
  • Severity of Illness Index
  • United States / epidemiology
  • United States Food and Drug Administration