A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)
A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)
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DOI：
10.3310/hta19570
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发表时间：
2015-07-01
影响因子：
3.6
通讯作者：
Young, Matthew J.
中科院分区：
文献类型：
--
作者：
Crawford, Fay;Cezard, Genevieve;Young, Matthew J.
背景：国家和国际临床指南建议对糖尿病患者进行年度足部风险评估。目的：我们对糖尿病患者的个体数据(IPD)进行了系统的回顾，以确定糖尿病患者足部溃烂的最高预后因素(即症状、体征、诊断测试)。资料来源：通过搜索MEDLINE和EMBASE来确定研究。综述方法：对MEDLINE和EMBASE数据库的电子搜索策略被更新并重新运行至2013年1月。该数据库是在对糖尿病足部溃烂的预测因素进行系统综述时创建的。一位审查员将IPD审查资格标准应用于我们的文献搜索中确定的研究全文，并将其应用于我们的总体系统审查之外的所有研究，以确保我们不会错过符合条件的IPD。第二个审查者将资格标准应用于摘要搜索收益率的10%随机样本，以检查没有遗漏相关材料。这篇综述包括暴露变量(危险因素)，仅来自在研究进入时没有足部溃疡且已被诊断为糖尿病(1型或2型)的个体。结果：我们的搜索确定了16项队列研究，我们获得了10项匿名的IPD。这些数据是从全球超过16,000名糖尿病患者中收集的，并由我们重新分析。保留了一个数据集以供独立验证。构成IPD的数据集涵盖了一系列的时间、地理和临床环境。因此，我们选择了随机效应荟萃分析，它不是假设每个研究的所有估计值都是相同潜在真值的估计值，而是假设估计值属于相同的分布。我们使用特定的标准选择了用于荟萃分析的候选变量。在单变量荟萃分析后，国际指导委员会确定了临床上最重要的预测因素，并将其纳入主要的多变量荟萃分析。年龄、性别、糖尿病病程、单丝和脉搏被认为是最重要的预后因素。基于整个IPD人群数据的Meta分析发现，感觉不到10克单丝[优势比(OR)3.184，95%可信区间(CI)2.654至3.82]、至少一个踏板脉搏缺失(OR 1.968，95%CI 1.624至2.386)、较长的糖尿病诊断持续时间(OR 1.024，95%CI 1.011至1.036)和既往溃疡病史(OR 6.589，95%CI 2.488至17.45)都是危险的预测因素。女性性行为具有保护性(OR 0.743，95%CI 0.598至0.922)。限制：不可能使用一步法进行荟萃分析，因为我们无法获得其中一个数据集的副本，而是通过安全避难所获取数据。结论：本综述的结果确定了风险评估程序，可以可靠地为国内和国际糖尿病临床指南足部风险评估程序提供参考。来自世界各地的大样本患者的证据表明，使用10克单丝或一个缺失的踏板脉冲将识别出那些有中度或中度足部溃疡风险的人，而足部溃疡或下肢截肢的病史足以识别那些高危人群。我们建议使用以下预测变量从我们现有的模型开发临床预测规则(CPR)：对10g单丝不敏感、无踏板脉冲和溃疡或下肢截肢病史。这种CPR可以取代患者目前使用的许多测试、体征和症状，这些设备要么昂贵，要么难以使用。
Background: Annual foot risk assessment of people with diabetes is recommended in national and international clinical guidelines. At present, these are consensus based and use only a proportion of the available evidence.Objectives: We undertook a systematic review of individual patient data (IPD) to identify the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes.Data sources: Studies were identified from searches of MEDLINE and EMBASE.Review methods: The electronic search strategies for MEDLINE and EMBASE databases created during an aggregate systematic review of predictive factors for foot ulceration in diabetes were updated and rerun to January 2013. One reviewer applied the IPD review eligibility criteria to the full-text articles of the studies identified in our literature search and also to all studies excluded from our aggregate systematic review to ensure that we did not miss eligible IPD. A second reviewer applied the eligibility criteria to a 10% random sample of the abstract search yield to check that no relevant material was missed. This review includes exposure variables (risk factors) only from individuals who were free of foot ulceration at the time of study entry and who had a diagnosis of diabetes mellitus (either type 1 or type 2). The outcome variable was incident ulceration.Results: Our search identified 16 cohort studies and we obtained anonymised IPD for 10. These data were collected from more than 16,000 people with diabetes worldwide and reanalysed by us. One data set was kept for independent validation. The data sets contributing IPD covered a range of temporal, geographical and clinical settings. We therefore selected random-effects meta-analysis, which assumes not that all the estimates from each study are estimates of the same underlying true value, but rather that the estimates belong to the same distribution. We selected candidate variables for meta-analysis using specific criteria. After univariate meta-analyses, the most clinically important predictors were identified by an international steering committee for inclusion in the primary, multivariable meta-analysis. Age, sex, duration of diabetes, monofilaments and pulses were considered most prognostically important. Meta-analyses based on data from the entire IPD population found that an inability to feel a 10-g monofilament [odds ratio (OR) 3.184, 95% confidence interval (CI) 2.654 to 3.82], at least one absent pedal pulse (OR 1.968, 95% CI 1.624 to 2.386), a longer duration of a diagnosis of diabetes (OR 1.024, 95% CI 1.011 to 1.036) and a previous history of ulceration (OR 6.589, 95% CI 2.488 to 17.45) were all predictive of risk. Female sex was protective (OR 0.743, 95% CI 0.598 to 0.922).Limitations: It was not possible to perform a meta-analysis using a one-step approach because we were unable to procure copies of one of the data sets and instead accessed data via Safe Haven.Conclusions: The findings from this review identify risk assessment procedures that can reliably inform national and international diabetes clinical guideline foot risk assessment procedures. The evidence from a large sample of patients in worldwide settings show that the use of a 10-g monofilament or one absent pedal pulse will identify those at moderate or intermediate risk of foot ulceration, and a history of foot ulcers or lower-extremity amputation is sufficient to identify those at high risk. We propose the development of a clinical prediction rule (CPR) from our existing model using the following predictor variables: insensitivity to a 10-g monofilament, absent pedal pulses and a history of ulceration or lower-extremities amputations. This CPR could replace the many tests, signs and symptoms that patients currently have measured using equipment that is either costly or difficult to use.