Clinical evaluation of a new device in the assessment of peripheral sensory neuropathy in diabetes
Clinical evaluation of a new device in the assessment of peripheral sensory neuropathy in diabetes
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DOI：
10.1111/j.1464-5491.2012.03729.x
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发表时间：
2012-12-01
影响因子：
3.5
通讯作者：
Scammell, B. E.
中科院分区：
文献类型：
--
作者：
Bracewell, N.;Game, F.;Scammell, B. E.
糖尿病29，15531555（2012）摘要目的目前的国家健康和临床卓越研究所指南指出，糖尿病患者应每年检查他们的脚，以排除感觉障碍的迹象。VibraTip是一种产生振动刺激的新型一次性器械，其开发目的是筛查糖尿病患者的外周感觉神经病变。本研究旨在通过评估评估者内可靠性并比较VibraTip检测或排除周围感觉神经病变与其他床边方法的能力来评价该器械。方法对141例糖尿病患者（1型或2型）采用Neurosheiometer、10-g单丝、128-Hz音叉、Neurotip（TM）和VibraTip检查糖尿病周围感觉神经病变。在每只脚中未能感知= 25 V的Neuroshesiometer刺激被认为是存在外周感觉神经病的参考方法。为每种器械绘制受试者工作特征曲线，并计算诊断周围感觉神经病变的灵敏度、特异性、预测值和似然比。在18例患者中使用VibraTip进行了重复测试，并使用Cronbach α评估了评估者内可靠性。结果受试者工作特性曲线下面积分析显示，10 g单丝明显优于128 Hz音叉（P = 0.0056）和Neurotip（P = 0.0022），但与VibraTip无差异（P = 0.3214）。VibraTip的α系数计算为0.882，表明可靠性良好。结论VibraTip是一种与10 g单丝相当的器械，因此可以被认为是筛查糖尿病周围感觉神经病变的有用工具。
Diabet. Med. 29, 15531555 (2012) Abstract Aims Current National Institute for Health and Clinical Excellence guidelines state that patients with diabetes should have annual examination of their feet to exclude signs of sensory impairment. The VibraTip is a new disposable device producing a vibratory stimulus, which has been developed in order to screen for peripheral sensory neuropathy in diabetes. This study was designed to evaluate the device by assessing intra-rater reliability and comparing the ability of the VibraTip to detect or exclude peripheral sensory neuropathy with other bedside methods. Methods One hundred and forty-one patients with diabetes (Type 1 or Type 2) were examined for diabetic peripheral sensory neuropathy using a Neurothesiometer, 10-g monofilament, a 128-Hz tuning fork, a Neurotip (TM) and a VibraTip. The failure to perceive the Neurosthesiometer stimulus at = 25 V in either foot was considered the reference method for the presence of peripheral sensory neuropathy. Receiver operating characteristic curves were produced for each device and the sensitivity, specificity, predictive values and likelihood ratios for the diagnosis of peripheral sensory neuropathy were calculated. Repeat testing with the VibraTip was performed in 18 patients and intra-rater reliability assessed using Cronbach alpha. Results Analysis of the area under the receiver operating characteristic curves showed that the 10-g monofilament was significantly better than the 128-Hz tuning fork (P = 0.0056) and the Neurotip (P = 0.0022), but was no different from the VibraTip (P = 0.3214). The alpha coefficient for the VibraTip was calculated to be 0.882, indicating good reliability. Conclusions The VibraTip is a device comparable with the 10-g monofilament and therefore could be considered a useful tool for screening for peripheral sensory neuropathy in diabetes.