Validation of the HAS-BLED scale for the assessment of bleeding risk in patients on anticoagulation therapy with a diagnosis of venous thromboembolic disease.

Stephanie Ortiz-Gómez, Paula Ruiz-Talero, Oscar Muñoz
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Abstract

Background: Several models have been developed to assess bleeding risk in patients with venous thromboembolism, such as HAS-BLED, but their external validity has not been adequately assessed.

Objective: The objective of the study was to evaluate the discriminative ability and calibration of the HAS-BLED scale for predicting 1-month bleeding risk in patient's anticoagulated for venous thromboembolism.

Materials and methods: External validation study of a prediction model based on a retrospective cohort of patients with venous thromboembolism treated between November 2019 and January 2022. Calibration of the HAS-BLED scale was evaluated using the Hosmer-Lemeshow test and the ratio of observed to expect events within each risk category. Discriminatory ability was assessed using the area under the curve (AUC) of a receiver operating characteristic curve.

Results: We included 735 patients (median age 64 years, female sex 55.2%), pulmonary embolism was diagnosed in most patients (60.7%), and 4.9% presented bleeding events. Regarding calibration, the HAS-BLED scale systematically underestimates the risk both in the general population (ROE 3.76, p < 0.001) and in cancer patients (ROE 4.16). The Hosmer-Lemeshow test rejected the hypothesis of adequate calibration (p < 0.001). Discriminatory ability was limited both in the general population (AUC = 0.57, 95% confidence interval [CI]: 0.48-0.66) and in the subgroup with active cancer (AUC = 0.53, 95% CI: 0.36-0.69).

Conclusion: The HAS-BLED scale in patients with venous thromboembolism underestimates the risk of bleeding at 1 month and has a low ability to discriminate high-risk patients. Cautious interpretation of the scale is recommended until additional evidence is available.

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对 HAS-BLED 量表进行验证,以评估确诊为静脉血栓栓塞性疾病的抗凝治疗患者的出血风险。
背景:目前已开发出几种用于评估静脉血栓栓塞症患者出血风险的模型,如 HAS-BLED,但其外部有效性尚未得到充分评估:目前已开发出几种评估静脉血栓栓塞症患者出血风险的模型,如HAS-BLED,但其外部有效性尚未得到充分评估:本研究旨在评估 HAS-BLED 量表预测静脉血栓栓塞抗凝患者 1 个月出血风险的鉴别能力和校准:基于2019年11月至2022年1月期间接受治疗的静脉血栓栓塞症患者回顾性队列的预测模型的外部验证研究。使用 Hosmer-Lemeshow 检验和每个风险类别中观察到的事件与预期事件的比率评估 HAS-BLED 量表的校准。使用接收者操作特征曲线的曲线下面积(AUC)评估判别能力:我们共纳入了 735 名患者(中位年龄 64 岁,女性占 55.2%),大多数患者(60.7%)确诊为肺栓塞,4.9% 的患者出现了出血事件。在校准方面,HAS-BLED 量表系统性地低估了普通人群(ROE 3.76,P < 0.001)和癌症患者(ROE 4.16)的风险。Hosmer-Lemeshow 检验拒绝了充分校准的假设(p < 0.001)。在普通人群(AUC = 0.57,95% 置信区间[CI]:0.48-0.66)和活动性癌症亚组(AUC = 0.53,95% 置信区间:0.36-0.69)中,判别能力均有限:结论:HAS-BLED量表低估了静脉血栓栓塞患者1个月后的出血风险,对高危患者的鉴别能力较低。在获得更多证据之前,建议谨慎解释该量表。
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来源期刊
CiteScore
3.00
自引率
0.00%
发文量
60
审稿时长
>12 weeks
期刊介绍: The Revista de Investigación Clínica – Clinical and Translational Investigation (RIC-C&TI), publishes original clinical and biomedical research of interest to physicians in internal medicine, surgery, and any of their specialties. The Revista de Investigación Clínica – Clinical and Translational Investigation is the official journal of the National Institutes of Health of Mexico, which comprises a group of Institutes and High Specialty Hospitals belonging to the Ministery of Health. The journal is published both on-line and in printed version, appears bimonthly and publishes peer-reviewed original research articles as well as brief and in-depth reviews. All articles published are open access and can be immediately and permanently free for everyone to read and download. The journal accepts clinical and molecular research articles, short reports and reviews. Types of manuscripts: – Brief Communications – Research Letters – Original Articles – Brief Reviews – In-depth Reviews – Perspectives – Letters to the Editor
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