Arakaki Daichi, Iwata Mitsunaga, Terasawa Teruhiko
Department of Emergency Medicine and General Internal Medicine, Fujita Health University School of Medicine, 1-98 Dengakugakubo, Kutsukakecho, Toyoake, Achi, 470-1192, Toyoake, Aichi, Japan.
Department of Emergency and Critical Care, Nagoya University Hospital, Nagoya, Aichi, Japan.
Thromb J. 2024 Mar 28;22(1):31. doi: 10.1186/s12959-024-00603-w.
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.
国际静脉血栓栓塞症医学预防登记处（IMPROVE）出血风险评分是西方国家预测急性病内科住院患者出血风险的推荐风险评估模型（RAM）。然而，很少有研究评估其在亚洲本地环境中的预测性能。
我们回顾性确定了2016年7月5日至2021年7月5日期间入住我院普通内科的急性病青少年和成年人（年龄≥15岁），并从他们的电子病历中提取数据。感兴趣的结局是入院14天后严重和非严重但具有临床相关性出血的累积发生率。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风险组模型，我们估计了C统计量、预期和观察到的事件比率（E/O）、整体校准（CITL）以及校准斜率。此外，我们使用本地数据重新校准截距以更新RAM。
在纳入的3876例患者中，998例（26%）年龄≥85岁，而656例（17%）在重症监护病房住院。中位住院时间为14天。58例患者（1.5%）发生了具有临床相关性的出血，其中49例（1.3%）经历了严重出血。任何出血的敏感性、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 - 4.3%），严重出血的分别为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%）。任何出血的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），严重出血的分别为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）。更新模型显著纠正了观察到的校准不佳情况。
在我们的日本队列中，IMPROVE出血RAM保留了所报道的中等判别性能。模型重新校准显著改善了使用原始RAM获得的校准不佳情况。在将其引入临床实践之前，更新后的RAM需要进一步的验证研究和优化的阈值。
