The International Medical Prevention Registry for Venous Thromboembolism (IMPROVE) Bleeding Risk Score is the recommended risk assessment model (RAM) for predicting bleeding risk in acutely ill medical inpatients in Western countries. However, few studies have assessed its predictive performance in local Asian settings. We retrospectively identified acutely ill adolescents and adults (aged ≥ 15 years) who were admitted to our general internal medicine department between July 5, 2016 and July 5, 2021, and extracted data from their electronic medical records. The outcome of interest was the cumulative incidence of major and nonmajor but clinically relevant bleeding 14 days after admission. For the two-risk-group model, we estimated sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively). For the 11-risk-group model, we estimated C statistic, expected and observed event ratio (E/O), calibration-in-the-large (CITL), and calibration slope. In addition, we recalibrated the intercept using local data to update the RAM. Among the 3,876 included patients, 998 (26%) were aged ≥ 85 years, while 656 (17%) were hospitalized in the intensive care unit. The median length of hospital stay was 14 days. Clinically relevant bleeding occurred in 58 patients (1.5%), 49 (1.3%) of whom experienced major bleeding. Sensitivity, specificity, NPV, and PPV were 26.1% (95% confidence interval [CI]: 15.8–40.0%), 84.8% (83.6–85.9%), 98.7% (98.2–99.0%), and 2.5% (1.5–4.3%) for any bleeding and 30.9% (95% CI: 18.8–46.3%), 84.9% (83.7–86.0%), 99.0% (98.5–99.3%), and 2.5% (1.5–4.3%) for major bleeding, respectively. The C statistic, E/O, CITL, and calibration slope were 0.64 (95% CI: 0.58–0.71), 1.69 (1.45–2.05), − 0.55 (− 0.81 to − 0.29), and 0.58 (0.29–0.87) for any bleeding and 0.67 (95% CI: 0.60–0.74), 0.76 (0.61–0.87), 0.29 (0.00–0.58), and 0.42 (0.19–0.64) for major bleeding, respectively. Updating the model substantially corrected the poor calibration observed. In our Japanese cohort, the IMPROVE bleeding RAM retained the reported moderate discriminative performance. Model recalibration substantially improved the poor calibration obtained using the original RAM. Before its introduction into clinical practice, the updated RAM needs further validation studies and an optimized threshold.

中文翻译：

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国际医疗预防登记处静脉血栓栓塞出血风险评分的外部验证和更新，用于预测急症住院患者出血：日本的一项回顾性单中心队列研究

国际静脉血栓栓塞医学预防登记处 (IMPROVE) 出血风险评分是推荐的风险评估模型 (RAM)，用于预测西方国家急症住院患者的出血风险。然而，很少有研究评估其在亚洲当地环境中的预测性能。我们回顾性地识别了2016年7月5日至2021年7月5日期间入住我们普通内科的急性疾病青少年和成人（年龄≥15岁），并从他们的电子病历中提取数据。感兴趣的结果是入院后 14 天主要和非主要但临床相关出血的累积发生率。对于双风险组模型，我们估计了敏感性、特异性以及阳性和阴性预测值（分别为 PPV 和 NPV）。对于 11 个风险组模型，我们估计了 C 统计量、预期和观察事件比 (E/O)、大校准 (CITL) 和校准斜率。此外，我们使用本地数据重新校准截距以更新 RAM。在 3,876 名患者中，998 名（26%）年龄≥ 85 岁，656 名（17%）在重症监护室住院。中位住院时间为 14 天。 58 名患者 (1.5%) 发生临床相关出血，其中 49 名 (1.3%) 出现大出血。敏感性、特异性、NPV 和 PPV 分别为 26.1%（95% 置信区间 [CI]：15.8–40.0%）、84.8%（83.6–85.9%）、98.7%（98.2–99.0%）和 2.5%（1.5–任何出血的发生率为 4.3%)，大出血的发生率为 30.9% (95% CI: 18.8–46.3%)、84.9% (83.7–86.0%)、99.0% (98.5–99.3%) 和 2.5% (1.5–4.3%) ， 分别。 C 统计量、E/O、CITL 和校准斜率分别为 0.64 (95% CI: 0.58–0.71)、1.69 (1.45–2.05)、− 0.55 (− 0.81 至 − 0.29) 和 0.58 (0.29–0.87)。任何出血，大出血分别为 0.67 (95% CI: 0.60–0.74)、0.76 (0.61–0.87)、0.29 (0.00–0.58) 和 0.42 (0.19–0.64)。更新模型基本上纠正了观察到的不良校准。在我们的日本队列中，IMPROVE 出血 RAM 保留了报告的中等判别性能。模型重新校准大大改善了使用原始 RAM 获得的不良校准。在引入临床实践之前，更新的 RAM 需要进一步的验证研究和优化的阈值。