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糖尿病足溃疡发展风险分类的验证:一项多中心前瞻性队列研究。

Diabetic foot ulcer development risk classifications' validation: A multicentre prospective cohort study.

机构信息

MEDCIDES/CINTESIS - Departamento de Medicina da Comunidade Informação e Decisão em Saúde, Oporto University Faculty of Medicine, Oporto U753-FCT, Portugal.

Unidade de Saúde Familiar Aquae Flaviae, Chaves, Portugal.

出版信息

Diabetes Res Clin Pract. 2017 May;127:105-114. doi: 10.1016/j.diabres.2017.02.034. Epub 2017 Mar 9.

DOI:10.1016/j.diabres.2017.02.034
PMID:28340359
Abstract

AIMS

To prospectively validate the existing classifications to stratify subjects with diabetes mellitus (DM) by their risk of diabetic foot ulcer (DFU), in high and low risk settings.

METHODS

A prospective multicentre cohort study was conducted, including 446 subjects with DM without active DFU followed in the hospital or primary care setting. Demographic, clinical characterization variables, and those included in the classifications were collected at baseline. Subjects were followed for 1year, until DFU or death.

RESULTS

In our sample, with a mean age of 65years, 52% were male; 32 developed a DFU, 7 required an amputation and 18 died. Differences were found between participants' characteristics and classifications' accuracy according to the setting. The great majority of the variables were associated with higher DFU risk. Globally, classifications were highly and equally valid, positive predictive values (PV) were inferior to 40%, negative PV superior to 90% and area under the receiver operating characteristic curve superior to 0.75.

DISCUSSION

All the existing classifications are valid to be applied in high risk clinical context and have a very high capacity to categorize as low risk those subjects that will not develop a DFU. Further research is needed in the primary care setting.

摘要

目的

前瞻性验证现有的分类方法,以评估糖尿病患者(DM)发生糖尿病足溃疡(DFU)的风险,分别在高风险和低风险环境下进行分层。

方法

进行了一项前瞻性多中心队列研究,纳入了 446 例无活动性 DFU 的 DM 患者,在医院或初级保健机构中接受随访。在基线时收集了人口统计学、临床特征变量以及分类中包含的变量。对受试者进行了为期 1 年的随访,直至发生 DFU 或死亡。

结果

在我们的样本中,平均年龄为 65 岁,52%为男性;32 例发生了 DFU,7 例需要截肢,18 例死亡。根据环境的不同,参与者的特征和分类的准确性存在差异。大多数变量与更高的 DFU 风险相关。总体而言,这些分类方法具有高度和同等的有效性,阳性预测值(PV)均低于 40%,阴性预测值(PV)均高于 90%,受试者工作特征曲线下面积(AUC)均高于 0.75。

讨论

所有现有的分类方法在高风险临床环境中均有效,并且非常有能力将不会发生 DFU 的患者归类为低风险。在初级保健环境中需要进一步研究。

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