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An automated database case definition for serious bleeding related to oral anticoagulant use
Andrew Cunningham1, C Michael Stein, Cecilia P Chung
1Division of Clinical Pharmacology, Department of Medicine, Nashville, TN, USA.
Insights
An automated database case definition accurately identified bleeding-related hospitalizations. This tool achieved high positive predictive value (89-99%) and could specify bleeding anatomical sites for epidemiologic studies.
Area of Science:
- Pharmacovigilance
- Health Informatics
- Epidemiology
Background:
- Bleeding complications are a significant risk associated with anticoagulant medications.
- Accurate identification of bleeding events is crucial for epidemiological research.
Purpose of the Study:
- To develop and validate an automated database case definition for bleeding-related hospitalizations.
- To facilitate large-scale epidemiologic investigations of adverse bleeding events.
Main Methods:
- A retrospective cohort study of warfarin-related bleeding in Tennessee Medicaid enrollees (1990-2005).
- Developed an automated definition using inpatient diagnoses and procedures indicative of bleeding.
- Validated the definition through medical record review of 236 hospitalizations.
Main Results:
- The automated definition demonstrated a high positive predictive value (PPV) of 89% for bleeding-related hospitalizations.
- Clinical confirmation of bleeding was achieved in 89% of cases.
- The definition accurately identified specific anatomical sites of bleeding with 99% concordance (e.g., gastrointestinal, cerebral, genitourinary).
Conclusions:
- An automated database case definition for bleeding-related hospitalizations is effective and reliable.
- The developed definition has a high PPV (89-99%) and can accurately distinguish bleeding sites.
- This tool supports efficient and accurate epidemiologic research on bleeding complications.
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.
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