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Protocol for a systematic review and individual patient data meta-analysis of prognostic factors of foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)

机译:糖尿病人足溃疡预后因素的系统评价和个体患者数据荟萃分析的协议:预测糖尿病足溃疡的国际研究合作(PODUS)

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摘要

BackgroundDiabetes–related lower limb amputations are associated with considerable morbidity and mortality and are usually preceded by foot ulceration. The available systematic reviews of aggregate data are compromised because the primary studies report both adjusted and unadjusted estimates. As adjusted meta-analyses of aggregate data can be challenging, the best way to standardise the analytical approach is to conduct a meta-analysis based on individual patient data (IPD).There are however many challenges and fundamental methodological omissions are common; protocols are rare and the assessment of the risk of bias arising from the conduct of individual studies is frequently not performed, largely because of the absence of widely agreed criteria for assessing the risk of bias in this type of review. In this protocol we propose key methodological approaches to underpin our IPD systematic review of prognostic factors of foot ulceration in diabetes.Review questions;1. What are the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes?2. Can the data from each study be adjusted for a consistent set of adjustment factors?3. Does the model accuracy change when patient populations are stratified according to demographic and/or clinical characteristics?
机译:背景技术与糖尿病相关的下肢截肢与高发病率和高死亡率有关,通常在患足溃疡之前发生。由于主要研究报告了调整后和未调整后的估计值,因此无法获得对汇总数据的系统评价。由于对汇总数据进行调整后的荟萃分析可能具有挑战性,因此标准化分析方法的最佳方法是根据单个患者数据(IPD)进行荟萃分析。但是,挑战很多,基本的方法学遗漏是常见的;方案很少,并且由于个人研究的进行而引起的偏倚风险的评估通常不进行,这主要是因为在这种类型的评价中缺乏广泛认可的评估偏倚风险的标准。在本协议中,我们提出了关键的方法学方法来支持我们的IPD系统评估糖尿病足溃疡预后因素的系统评价。糖尿病患者足部溃疡最严重的预后因素是什么(即症状,体征,诊断检查)?2。是否可以针对一组一致的调整因子来调整每个研究的数据?3。当根据人口统计学和/或临床特征对患者人群进行分层时,模型的准确性会改变吗?

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