NDLI: Discrepancies in identification of major bleeding events in patients taking warfarin.

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Discrepancies in identification of major bleeding events in patients taking warfarin.

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Discrepancies in identification of major bleeding events in patients taking warfarin.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Seto, Anna C. Kenyon, Kenneth Wittkowsky, Ann K.
Description	Country affiliation: United States Author Affiliation: Seto AC ( University of Washington School of Pharmacy, Seattle, Washington 98195, USA.)
Abstract	STUDY OBJECTIVE: To assess the level of agreement between one subjective definition of major bleeding (criteria A) and two objective definitions: the International Society on Thrombosis and Haemostasis ([ISTH] criteria B) and the Italian Study of Complications of Anticoagulant Therapy ([ISCOAT] criteria C). DESIGN: Retrospective cohort study. SETTING: Four anticoagulation clinics at a university-affiliated medical center. PATIENTS: One hundred twenty patients aged 21-96 years who were taking long-term warfarin therapy and experienced a nonminor bleeding event between July 1, 2001, and June 30, 2006. MEASUREMENTS AND MAIN RESULTS: Bleeding events were evaluated using three definitions of major bleeding: criteria A-event was fatal or required hospitalization; criteria B-event was fatal, was symptomatic in a critical area or organ, caused a decrease in hemoglobin level of 2 g/dl or more, and/or led to transfusion of 2 or more units of whole blood or red blood cells; and criteria C-event met criteria B definition (but less inclusively identifies critical areas or organs) and/or necessitated surgical or angiographic intervention. One hundred thirty-eight bleeding events in the 120 patients met at least one of the definitions of major bleeding and thus were included in the analysis. Level of agreement among the definitions was determined by the kappa statistic. The level of agreement between criteria B and C was excellent; no discrepancies were found; however, the level of agreement between criteria A and criteria B or C was poor, with a kappa statistic value of -0.134 (95% confidence interval -0.196 to -0.071). Use of criteria A resulted in underreporting of 31 major bleeding events by excluding events that were managed on an outpatient basis. CONCLUSION: The discrepant event rates determined by using three different definitions of major bleeding underscore the need for implementation of a standardized objective definition. Use of a standardized definition in clinical trials to accurately predict and compare patient outcomes and in clinical practice as a marker for patient safety will increase quality of care and decrease total costs of care in patients treated with warfarin. We suggest implementation of the ISTH criteria in clinical practice as a method to standardize the reporting of major bleeding events.
File Format	HTM / HTML
ISSN	02770008
Issue Number	9
Volume Number	28
e-ISSN	18759114
Journal	Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2008-09-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Anticoagulants Adverse Effects Hemorrhage Chemically Induced Diagnosis Warfarin Adult Aged Aged, 80 And Over Cohort Studies Data Collection Data Interpretation, Statistical Female Mortality Humans Male Middle Aged Retrospective Studies Sex Factors Terminology As Topic Young Adult Journal Article
Content Type	Text
Resource Type	Article
Subject	Pharmacology (medical)

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