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首页> 外文期刊>BMC Medical Research Methodology >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)
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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综述和个人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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Background Diabetes–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? Methods MEDLINE and EMBASE databases from their inception until early 2012 were searched and the corresponding authors of all eligible primary studies invited to contribute their raw data. We developed relevant quality assurance items likely to identify occasions when study validity may have been compromised from several sources. A confidentiality agreement, arrangements for communication and reporting as well as ethical and governance considerations are explained. We have agreement from the corresponding authors of all studies which meet the eligibility criteria and they collectively possess data from more than 17000 patients. We propose, as a provisional analysis plan, to use a multi-level mixed model, using “study” as one of the levels. Such a model can also allow for the within-patient clustering that occurs if a patient contributes data from both feet, although to aid interpretation, we prefer to use patients rather than feet as the unit of analysis. We intend to only attempt this analysis if the results of the investigation of heterogeneity do not rule it out and the model diagnostics are acceptable. Discussion This review is central to the development of a global evidence-based strategy for the risk assessment of the foot in patients with diabetes, ensuring future recommendations are valid and can reliably inform international clinical guidelines.
机译：背景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。然而，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审查中缺乏广泛认可的评估偏倚风险的标准。在该协议中，我们提出了关键的方法学方法来巩固我们的IPD对糖尿病足溃疡预后因素的系统评价。检视问题; 1.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，模型的准确性会发生变化吗？方法检索MEDLINE和EMBASE数据库从成立到2012年初的信息，并邀请所有符合条件的基础研究的相应作者提供其原始数据。我们制定了相关的质量保证项目，有可能确定某些情况下研究有效性可能受到损害的情况。解释了保密协议，沟通和报告安排以及道德和治理方面的考虑。我们符合所有符合入选标准的研究的相应作者的同意，他们共同拥有来自17000多例患者的数据。作为临时分析计划，我们建议使用“研究”作为其中一个级别的多级混合模型。这种模型还可以考虑如果患者从双脚贡献数据时发生的患者内部聚类，尽管为了帮助解释，我们更倾向于使用患者而不是双脚作为分析单位。我们打算仅在不均一性调查的结果不排除这种分析且模型诊断可接受的情况下尝试这种分析。讨论该评论对于开发基于全球证据的糖尿病患者足部风险评估策略至关重要，以确保将来的建议有效并能够可靠地为国际临床指南提供依据。

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