Huang Jingying, Yang Jin, Qi Haiou, Xu Miaomiao, Xu Xin, Zhu Yiting
Postanesthesia Care Unit, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Nursing Department, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Diabetol Metab Syndr. 2024 Jun 10;16(1):126. doi: 10.1186/s13098-024-01360-6.
Numerous studies have developed or validated prediction models aimed at estimating the likelihood of amputation in diabetic foot (DF) patients. However, the quality and applicability of these models in clinical practice and future research remain uncertain. This study conducts a systematic review and assessment of the risk of bias and applicability of amputation prediction models among individuals with DF.
A comprehensive search was conducted across multiple databases, including PubMed, Web of Science, EBSCO CINAHL Plus, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang, Chinese Biomedical Literature Database (CBM), and Weipu (VIP) from their inception to December 24, 2023. Two investigators independently screened the literature and extracted data using the checklist for critical appraisal and data extraction for systematic reviews of prediction modeling studies. The Prediction Model Risk of Bias Assessment Tool (PROBAST) checklist was employed to evaluate both the risk of bias and applicability.
A total of 20 studies were included in this analysis, comprising 17 development studies and three validation studies, encompassing 20 prediction models and 11 classification systems. The incidence of amputation in patients with DF ranged from 5.9 to 58.5%. Machine learning-based methods were employed in more than half of the studies. The reported area under the curve (AUC) varied from 0.560 to 0.939. Independent predictors consistently identified by multivariate models included age, gender, HbA1c, hemoglobin, white blood cell count, low-density lipoprotein cholesterol, diabetes duration, and Wagner's Classification. All studies were found to exhibit a high risk of bias, primarily attributed to inadequate handling of outcome events and missing data, lack of model performance assessment, and overfitting.
The assessment using PROBAST revealed a notable risk of bias in the existing prediction models for amputation in patients with DF. It is imperative for future studies to concentrate on enhancing the robustness of current prediction models or constructing new models with stringent methodologies.
众多研究已开发或验证了旨在估计糖尿病足(DF)患者截肢可能性的预测模型。然而,这些模型在临床实践和未来研究中的质量及适用性仍不确定。本研究对DF患者中截肢预测模型的偏倚风险和适用性进行了系统评价与评估。
对多个数据库进行全面检索,包括PubMed、Web of Science、EBSCO CINAHL Plus、Embase、Cochrane图书馆、中国知网(CNKI)、万方、中国生物医学文献数据库(CBM)和维普(VIP),检索时间从各数据库建库至2023年12月24日。两名研究者独立筛选文献,并使用预测模型研究系统评价的关键评估和数据提取清单提取数据。采用预测模型偏倚风险评估工具(PROBAST)清单评估偏倚风险和适用性。
本分析共纳入20项研究,包括17项开发研究和3项验证研究,涵盖20个预测模型和11个分类系统。DF患者的截肢发生率在5.9%至58.5%之间。超过半数的研究采用了基于机器学习的方法。报告的曲线下面积(AUC)在0.560至0.939之间。多变量模型一致确定的独立预测因素包括年龄、性别、糖化血红蛋白、血红蛋白、白细胞计数、低密度脂蛋白胆固醇、糖尿病病程和Wagner分级。所有研究均显示出较高的偏倚风险,主要归因于结局事件和缺失数据处理不当、缺乏模型性能评估以及过度拟合。
使用PROBAST进行的评估显示,现有DF患者截肢预测模型存在显著的偏倚风险。未来的研究必须专注于提高当前预测模型的稳健性或采用严格方法构建新模型。