An automated database case definition for serious bleeding related to oral anticoagulant use
Article first published online: 8 MAR 2011
Copyright © 2011 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 20, Issue 6, pages 560–566, June 2011
How to Cite
Cunningham, A., Stein, C. M., Chung, C. P., Daugherty, J. R., Smalley, W. E. and Ray, W. A. (2011), An automated database case definition for serious bleeding related to oral anticoagulant use. Pharmacoepidem. Drug Safe., 20: 560–566. doi: 10.1002/pds.2109
- Issue published online: 23 JUN 2011
- Article first published online: 8 MAR 2011
- Manuscript Accepted: 28 DEC 2010
- Manuscript Revised: 21 DEC 2010
- Manuscript Received: 27 MAY 2010
- bleeding complications;
- positive predictive value
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.
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.
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.
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. Copyright © 2011 John Wiley & Sons, Ltd.