NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Chu Hsien-I Memorial Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin, China.
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.
Diabetes Metab Res Rev. 2023 May;39(4):e3616. doi: 10.1002/dmrr.3616. Epub 2023 Feb 4.
To develop and validate a risk prediction model for Chinese patients with type 2 diabetes with the recurrence of diabetic foot ulcers (DFUs) based on a systematic review and meta-analysis.
A prospective analysis was performed with 1333 participants and followed up for 60 months. Three models were analysed using a derived cohort. The risk factors were screened using meta-analysis and logistic regression, and the missing variables were interpolated by multiple imputation. The internal validation was performed using the bootstrap procedure, and the validation cohort was applied to the external validation. The performance of the model was evaluated in the area under the discrimination Receiver Operating Characteristic Curve (ROC). Calibration and discrimination methods were used for the validation cohort. The variables were selected according to their clinical and statistical importance to construct the nomograms.
Three models were developed and validated. Model 1 included seven social and clinical indicators like sex, diabetes mellitus duration, previous DFU, location of ulcer, smoking, history of amputation, and foot deformity. Model 2 included four more indicators besides those in Model 1, which were statin agents used, antiplatelet agents used, systolic blood pressure, and body mass index. Model 3 added further laboratory indicators to Model 2, such as LDL-C, HbA1C, fibrinogen, and blood urea nitrogen. In the derivation cohort, 20.1% (206/1027) participants with DFU recurred as compared to the validation cohort, which was 38.2% (117/306). The areas under the curve in the derivation cohort for Models 1-3 were 0.781 (0.744-0.817), 0.843 (0.813-0.873), and 0.899 (0.876-0.922), respectively. The Youden indexes for Models 1-3 were 0.430, 0.559, and 0.653, respectively. Model 3 showed the highest sensitivity and specificity. All models performed well for both discrimination and calibration.
Models 1-2 were non-invasive, which indicate their role in general screening for patients at a high risk of recurrence of DFU. However, Model 3 offers a more specific screening due to its best performance in predicting the risk of DFU recurrence amongst the three models.
基于系统评价和荟萃分析，为中国 2 型糖尿病患者（T2DM）糖尿病足溃疡（DFU）复发风险预测建立并验证一个风险预测模型。
前瞻性分析了 1333 名参与者，并进行了 60 个月的随访。使用衍生队列分析了三个模型。使用荟萃分析和逻辑回归筛选风险因素，使用多重插补法插补缺失变量。通过自举程序进行内部验证，并将验证队列应用于外部验证。在判别接收者操作特征曲线（ROC）下的面积评估模型的性能。使用校准和判别方法对验证队列进行验证。根据模型的临床和统计学重要性选择变量来构建列线图。
建立并验证了三个模型。模型 1 包含 7 个社会和临床指标，如性别、糖尿病病程、既往 DFU、溃疡位置、吸烟、截肢史和足部畸形。模型 2 除了模型 1 中的 4 个指标外，还包括他汀类药物、抗血小板药物、收缩压和体重指数。模型 3 在模型 2 的基础上增加了进一步的实验室指标，如 LDL-C、HbA1C、纤维蛋白原和血尿素氮。在衍生队列中，20.1%（206/1027）的 DFU 复发患者与验证队列中 38.2%（117/306）的患者相比。在衍生队列中，模型 1-3 的曲线下面积分别为 0.781（0.744-0.817）、0.843（0.813-0.873）和 0.899（0.876-0.922）。模型 1-3 的约登指数分别为 0.430、0.559 和 0.653。模型 3 显示出最高的敏感性和特异性。所有模型在判别和校准方面都表现良好。
模型 1-2 是非侵入性的，表明它们在一般筛查高风险 DFU 复发患者方面具有作用。然而，模型 3 提供了更具体的筛查，因为它在预测三种模型中 DFU 复发风险方面表现最佳。
