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

Abstract

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 through 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.

Effectiveness and Safety of Apixaban, Dabigatran, and Rivaroxaban Versus Warfarin in Frail Patients With Nonvalvular Atrial Fibrillation

“…The occurrence of SSE during the observation period was determined by the presence of an appropriate inpatient discharge diagnosis code in the primary position. Major bleeding was our primary safety outcome and was determined using the validated Cunningham algorithm for detection of bleeding‐related hospitalizations 15. Patients were followed for a maximum of 2 years or until the occurrence of a thrombotic or major bleeding outcome, insurance disenrollment or end of study follow‐up (intention‐to‐treat analysis).…”

Comparative effectiveness of direct oral anticoagulants and warfarin in patients with cancer and atrial fibrillation

“…14 Gastrointestinal bleeding was defined following the algorithm developed by Cunningham et al 15 This algorithm considers presence of bleeding-related ICD-9-CM codes in inpatient claims as primary and secondary diagnoses, presence of transfusion codes (hospital revenue code indicating transfusion/cross-matching for transfusion), and presence/absence of trauma codes to exclude trauma-related bleeding. The PPV of this algorithm is 86%, which is comparable to other peer-reviewed algorithms.…”

“…16 Other bleeding was defined as genitourinary bleeding, hemopericardium, hemoperitoneum, hemarthrosis, epistaxis, hemoptysis, hemorrhage from throat, and unspecified hemorrhage. 15 Ischemic stroke was defined based on the presence of ICD-9-CM codes 434.xx (occlusion of cerebral arteries) and 436.xx (acute but illdefined cerebrovascular disease) as the primary discharge diagnosis in any inpatient claim following the index date. A PPV of .80% has been reported in several validation studies that used this definition.…”

Clinical outcomes of prolonged anticoagulation with rivaroxaban after unprovoked venous thromboembolism

“…Major bleeding events were defined as hospitalizations for major bleeding events identified based on Cunningham et al. 's validated algorithm 22. Time to first recurrent VTE and time to first major bleeding event from the index date were measured and patients who did not have the event of interest were censored at the end of the observation period.…”