Zhao Binliang, Hao Bin, Xu Huimin, Premaratne Shyamal, Zhang Jiantao, Jiao Le, Zhang Wenpei, Wang Shengquan, Su Xudong, Sun Lei, Yao Jie, Yu Ying, Yang Tao
Department of Vascular Surgery, The Affiliated Da Yi Hospital of Shanxi Medical University, China.
Hunter Holmes McGuire Veterans Administration Medical Center, Richmond, VA.
Ann Vasc Surg. 2020 Jul;66:334-343. doi: 10.1016/j.avsg.2019.12.008. Epub 2020 Jan 3.
To develop and verify a risk predictive model/scoring system for pulmonary embolism (PE) among hospitalized patients with deep venous thrombosis of the lower extremities (LDVT).
776 patients with LDVT were enrolled in a case-control study between January 2016 and June 2017 from the Vascular Surgery Department of Shanxi Dayi Hospital, China. They were randomly divided into development (543 patients, 70%) and validation (233 patients, 30%) databases. Based on the results of pulmonary computed tomography arteriography, patients were divided into 2 categories; those with PE were designated as the case group, whereas those without comprised the controls. A logistic regression model and scoring system for PE in patients with LDVT was established in the development database and verified in the validation database. Scoring system (Shanxi Dayi Hospital score [SDH score]) was tabulated as follows: right lower extremity or bilateral lower extremities, 1; surgery or immobilization, 1; malignant tumor, 1; history of venous thromboembolism (VTE), 2; D-dimer >1,000 ng/mL, 2; and unprovoked, 2. Calibration and discrimination of the model were assessed by the Hosmer-Lemeshow goodness of fit test and the area under the receiver operating characteristic curve (AUC). Wells score, the Revised Geneva score, and the SDH score for predictive value of PE by AUC in the validation database were compared.
776 patients with LDVT were divided into 2 risk categories based on the scores from the risk model as follows: PE unlikely (score <3) and PE likely (score ≥3). Sensitivity, specificity, and crude agreement of the SDH score in the development database were 76.39%, 55.89%, and 61.33%, respectively. In the validation database, the logistic regression model showed good calibration and discriminative power. The Hosmer-Lemeshow goodness of fit test P value was >0.05, and the AUC was 0.705 (95% CI: 0.634-0.776, P < 0.001). The SDH score also showed good discriminative power, and the AUC was 0.702 (95% CI: 0.631-0.774, P < 0.001). Sensitivity, specificity, and crude agreement of the SDH score in the validation database were 67.61%, 61.73%, and 63.52%, respectively. AUC for the Wells score and the Revised Geneva score was 0.611 (95% CI: 0.533-0.688, P = 0.007) and 0.585 (95% CI: 0.503-0.666, P = 0.040), respectively. Difference of the AUC was not statistically significant between the Wells score and the SDH score (0.611 vs. 0.702, P = 0.059) but was so between the Revised Geneva score and the SDH score (0.585 vs. 0.702, P = 0.016). Sensitivity of the Wells score, Revised Geneva score, and the SDH score (64.79%, 67.61% vs. 67.61%) was not statistically significant. However, the specificity of the Wells score and Revised Geneva score was significantly lower than that of the SDH score (48.77%, 39.51% vs. 61.73%).
Our logistic regression model and the SDH score based on 7 risk factors as right lower extremity, bilateral lower extremities, unprovoked, surgery or immobilization, malignant tumor, history of VTE, and D-dimer>1,000 ng/mL showed good calibration and discriminative power for the assessment of PE risk in patients with LDVT. The SDH score is more specific for PE prediction in the Chinese population, compared with the Wells score and the Revised Geneva score.
开发并验证一种用于下肢深静脉血栓形成(LDVT)住院患者肺栓塞(PE)的风险预测模型/评分系统。
2016年1月至2017年6月期间,从中国山西大医院血管外科纳入776例LDVT患者进行病例对照研究。他们被随机分为开发数据库(543例患者,70%)和验证数据库(233例患者,30%)。根据肺计算机断层扫描血管造影结果,患者分为两类;患有PE的患者被指定为病例组,而未患PE的患者为对照组。在开发数据库中建立了LDVT患者PE的逻辑回归模型和评分系统,并在验证数据库中进行验证。评分系统(山西大医院评分[SDH评分])如下:右下肢或双下肢,1分;手术或制动,1分;恶性肿瘤,1分;静脉血栓栓塞症(VTE)病史,2分;D-二聚体>1000 ng/mL,2分;无诱因,2分。通过Hosmer-Lemeshow拟合优度检验和受试者操作特征曲线下面积(AUC)评估模型的校准和辨别力。比较了验证数据库中Wells评分、修订版Geneva评分和SDH评分对PE预测价值的AUC。
根据风险模型的评分,776例LDVT患者分为2个风险类别:PE不太可能(评分<3)和PE可能(评分≥3)。开发数据库中SDH评分的敏感性、特异性和粗一致性分别为76.39%、55.89%和61.33%。在验证数据库中,逻辑回归模型显示出良好的校准和辨别力。Hosmer-Lemeshow拟合优度检验P值>0.05,AUC为0.705(95%CI:0.634-0.776,P<0.001)。SDH评分也显示出良好的辨别力,AUC为0.702(95%CI:0.631-0.774,P<0.001)。验证数据库中SDH评分的敏感性、特异性和粗一致性分别为67.61%、61.73%和63.52%。Wells评分和修订版Geneva评分的AUC分别为0.611(95%CI:0.533-0.688,P=0.007)和0.585(95%CI:0.503-0.666,P=0.040)。Wells评分和SDH评分之间的AUC差异无统计学意义(0.611对0.702,P=0.059),但修订版Geneva评分和SDH评分之间的差异有统计学意义(0.585对0.702,P=0.016)。Wells评分、修订版Geneva评分和SDH评分的敏感性(64.79%、67.61%对67.61%)无统计学意义。然而,Wells评分和修订版Geneva评分的特异性显著低于SDH评分(48.77%、39.51%对61.73%)。
我们基于右下肢、双下肢、无诱因、手术或制动、恶性肿瘤、VTE病史和D-二聚体>1000 ng/mL这7个风险因素的逻辑回归模型和SDH评分,在评估LDVT患者的PE风险方面显示出良好的校准和辨别力。与Wells评分和修订版Geneva评分相比,SDH评分在中国人群中对PE预测更具特异性。