背景:许多研究已经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和适用性仍不确定.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的回顾和评估。
方法:在多个数据库中进行了全面搜索,包括PubMed,WebofScience,EBSCOCINAHLPlus,Embase,科克伦图书馆,中国国家知识基础设施(CNKI),万方,中国生物医学文献数据库(CBM),和维普(VIP)从成立到2023年12月24日。两名调查人员独立筛选了文献,并使用检查表进行了关键评估和数据提取,以对预测模型研究进行系统评价。采用预测模型偏差风险评估工具(PROBAST)检查表评估偏差风险和适用性。
结果:本分析共纳入20项研究,包括17项发展研究和三项验证研究,包括20个预测模型和11个分类系统。DF患者截肢的发生率为5.9%至58.5%。超过一半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之间变化。多变量模型一致确定的独立预测因素包括年龄,性别,HbA1c,血红蛋白,白细胞计数,低密度脂蛋白胆固醇,糖尿病持续时间,和瓦格纳的分类。所有研究都被发现有很高的偏倚风险,主要归因于对结果事件的处理不当和数据缺失,缺乏典型的绩效评估,和过度拟合。
结论:使用PROBAST进行的评估显示,在DF患者截肢的现有预测模型中存在显著的偏倚风险。未来的研究必须专注于增强当前预测模型的鲁棒性或以严格的方法构建新模型。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.