An automated database case definition for serious bleeding related to oral anticoagulant use

Pharmacoepidemiol Drug Saf. 2011 Jun;20(6):560-6. doi: 10.1002/pds.2109. Epub 2011 Mar 8.


Purpose: Bleeding complications are a serious adverse effect of medications that prevent abnormal blood clotting. To facilitate epidemiologic investigations of bleeding complications, we developed and validated an automated database case definition for bleeding-related hospitalizations.

Methods: The case definition utilized information from an in-progress retrospective cohort study of warfarin-related bleeding in Tennessee Medicaid enrollees 30 years of age or older. It identified inpatient stays during the study period of January 1990 to December 2005 with diagnoses and/or procedures that indicated a current episode of bleeding. The definition was validated by medical record review for a sample of 236 hospitalizations.

Results: We reviewed 186 hospitalizations that had medical records with sufficient information for adjudication. Of these, 165 (89%, 95%CI: 83-92%) were clinically confirmed bleeding-related hospitalizations. An additional 19 hospitalizations (10%, 7-15%) were adjudicated as possibly bleeding-related. Of the 165 clinically confirmed bleeding-related hospitalizations, the automated database and clinical definitions had concordant anatomical sites (gastrointestinal, cerebral, genitourinary, other) for 163 (99%, 96-100%). For those hospitalizations with sufficient information to distinguish between upper/lower gastrointestinal bleeding, the concordance was 89% (76-96%) for upper gastrointestinal sites and 91% (77-97%) for lower gastrointestinal sites.

Conclusion: A case definition for bleeding-related hospitalizations suitable for automated databases had a positive predictive value of between 89% and 99% and could distinguish specific bleeding sites.

Publication types

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

MeSH terms

  • Adult
  • Anticoagulants / adverse effects*
  • Automation
  • Cohort Studies
  • Databases, Factual*
  • Epidemiologic Methods
  • Hemorrhage / chemically induced*
  • Hemorrhage / epidemiology
  • Hospitalization / statistics & numerical data
  • Humans
  • Medicaid
  • Predictive Value of Tests
  • Retrospective Studies
  • Severity of Illness Index
  • Tennessee
  • United States
  • Warfarin / adverse effects*


  • Anticoagulants
  • Warfarin