Clinical research studyScores to Predict Major Bleeding Risk During Oral Anticoagulation Therapy: A Prospective Validation Study
Section snippets
Study Design and Setting
This prospective cohort study was conducted in the Internal Medicine and Ambulatory Care and Community Medicine Departments of Lausanne University Hospital, Switzerland. The protocol was approved by the institutional review board, and all participants gave their informed consent.
Study Population
We included all consecutive patients aged ≥ 18 years who were receiving oral anticoagulant therapy at the time of hospital discharge or at presentation in the ambulatory clinic from January 1, 2008, to March 31, 2009.
Study Population
Of 650 consecutive patients receiving oral anticoagulant therapy who were screened between January 1, 2008, and March 31, 2009, we excluded 132 patients (20.8%) because of refusal or inability to give informed consent. We further excluded 3 patients (0.5%) who withdrew consent within a few weeks of the start of the study, leaving a final sample of 515 patients. The 3 patients who withdrew consent did not have a bleeding event before withdrawal. Excluded patients were significantly older than
Discussion
We found that existing clinical scores poorly predict major bleeding events in unselected internal medicine patients receiving oral anticoagulant therapy. The C statistics ranged from 0.54 to 0.61 with 95% CIs crossing 0.50 for all scores except the ATRIA score. This suggests that the discriminatory power was not better than would have been expected due to chance alone for all scores except the ATRIA score, which performed only slightly better.19 Furthermore, overall score performances were not
Conclusions
Our results indicate that clinical scores poorly predict the risk of major bleeding in unselected patients receiving oral anticoagulant therapy. Score performances do not seem to be better than physicians' subjective assessments. Novel clinical risk assessment methods that accurately and reliably predict the risk of major bleeds among those receiving oral anticoagulant therapy are needed.
Acknowledgments
The authors thank Dr Jeffrey Schnipper, assistant professor of medicine at the Harvard School of Medicine (Boston, MA), for careful review of the article. Dr J. Schnipper played no role in the design or conduct of the study, or in the collection, management, or interpretation of the data.
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Funding: This study was supported by an intramural grant (CardioMet) from the University Hospital Lausanne, Switzerland. Dr Jacques Donzé was supported by grants provided by the Swiss National Science Foundation (PBLAP3-131814 and PBLAP3-136815). The providers of the grants played no role in the design or conduct of the study, or in the collection, management, or interpretation of the data.
Conflict of Interest: None.
Authorship: All authors had access to the data and played a role in writing this manuscript.