O'Meara S, Nelson E A, Golder S, Dalton J E, Craig D, Iglesias C
Department of Health Sciences, University of York, York, UK.
Diabet Med. 2006 Apr;23(4):341-7. doi: 10.1111/j.1464-5491.2006.01830.x.
To undertake a systematic review of the diagnostic performance of clinical examination, sample acquisition and sample analysis in infected foot ulcers in diabetes.
Nineteen electronic databases plus other sources were searched. To be included, studies had to fulfil the following criteria: (i) compare a method of clinical assessment, sample collection or sample analysis with a reference standard; (ii) recruit diabetic individuals with foot ulcers; (ii) present 2 x 2 diagnostic data. Studies were critically appraised using a 12-item checklist.
Three eligible studies were identified, one each on clinical examination, sample collection and sample analysis. For all three, study groups were heterogeneous with respect to wound type and a small proportion of participants had foot ulcers due to diabetes. No studies identified an optimum reference standard. Other methodological problems included non-blind interpretation of tests and the time lag between index and reference tests. Individual signs or symptoms of infection did not prove to be useful tests when assessed against punch biopsy as the reference standard. The wound swab did not perform well when assessed against tissue biopsy. Semiquantitative analysis of wound swab might be a useful alternative to quantitative analysis. The limitations of these findings and their impact on recommendations from relevant clinical guidelines are discussed.
Given the importance of this topic, it is surprising that only three eligible studies were identified. It was not possible to describe the optimal methods of diagnosing infection in diabetic patients with foot ulceration from the evidence identified in this systematic review.
对糖尿病足部感染溃疡的临床检查、样本采集及样本分析的诊断性能进行系统评价。
检索了19个电子数据库及其他来源。纳入研究须符合以下标准：（i）将一种临床评估、样本采集或样本分析方法与参考标准进行比较；（ii）招募患有足部溃疡的糖尿病患者；（ii）呈现2×2诊断数据。使用一份包含12项条目的清单对研究进行严格评价。
共识别出三项符合条件的研究，分别涉及临床检查、样本采集和样本分析。对于所有三项研究，研究组在伤口类型方面存在异质性，且一小部分参与者的足部溃疡由糖尿病引起。没有研究确定最佳参考标准。其他方法学问题包括检查的非盲法解读以及指标检查与参考检查之间的时间间隔。以打孔活检作为参考标准进行评估时，感染的个体体征或症状未被证明是有用的检查。以组织活检作为参考标准进行评估时，伤口拭子表现不佳。伤口拭子的半定量分析可能是定量分析的一种有用替代方法。讨论了这些发现的局限性及其对相关临床指南建议的影响。
鉴于该主题的重要性，仅识别出三项符合条件的研究令人惊讶。根据本系统评价中确定的证据，无法描述诊断糖尿病足部溃疡患者感染的最佳方法。
