Perkins B A, Olaleye D, Zinman B, Bril V
Beth Israel Deaconness Medical Center and Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.
Diabetes Care. 2001 Feb;24(2):250-6. doi: 10.2337/diacare.24.2.250.
The utility of rapid and reliable sensory tests appropriate for the diagnosis of neuropathy in the diabetes clinic, rather than as prognostic tools for the prediction of foot complications, has been unclear because of limitations inherent in previous studies. Although clinical practice guidelines recommend annual screening for neuropathy, they are unable to support specific recommendations for screening maneuvers because of a lack of evidence for the validity of screening tests in the medical literature. The objective of this study was to assess the operating characteristics of four simple sensory screening maneuvers as compared with standardized electrophysiological tests in the diagnosis of distal symmetrical polyneuropathy.
We assessed four simple tests (the 10-g Semmes-Weinstein monofilament examination [SWME], superficial pain sensation, vibration testing by the on-off method, and vibration testing by the timed method) in 478 subjects with independent blinded evaluations compared against the criterion standard of nerve conduction studies. We present receiver-operating characteristic (ROC) curves, positive and negative likelihood ratios, and sensitivity and specificity values for each test.
The four simple screening maneuvers reveal similar operating characteristics. Cutoff points by ROC curve analyses reveal that a positive or abnormal test is represented by five incorrect responses of eight stimuli applied. A negative or normal test is represented by one or fewer incorrect responses of eight stimuli applied. By these criteria, the point estimates of the positive likelihood ratios for vibration testing by the on-off method, vibration testing by the timed method, the SWME, and superficial pain sensation test are 26.6, 18.5, 10.2, and 9.2, respectively. The point estimates of the negative likelihood ratios are 0.33, 0.51, 0.34, and 0.50, respectively The screening tests showed comparable sensitivity and specificity results. The 10-g SWME, superficial pain test, and vibration testing by the on-off method are rapid, each requiring approximately 60 s to administer. The timed vibration test takes longer, and the interpretation is more complicated. The combination of two simple tests (e.g., the 10-g SWME and vibration testing by the on-off method) does not add value to each individual screening test.
Annual screening for diabetic neuropathy should be conducted using superficial pain sensation testing, SWME, or vibration testing by the on-off method. The reported operating characteristics for each sensory modality can be applied to positive findings on the physical examination of individual patients to predict the likelihood of neuropathy.
由于既往研究存在固有局限性，适用于糖尿病门诊神经病变诊断而非预测足部并发症预后工具的快速可靠感觉测试的效用尚不清楚。尽管临床实践指南建议每年进行神经病变筛查，但由于医学文献中缺乏筛查测试有效性的证据，它们无法支持关于筛查操作的具体建议。本研究的目的是评估四种简单感觉筛查操作与标准化电生理测试相比在诊断远端对称性多发性神经病变中的操作特征。
我们对478名受试者进行了四项简单测试（10克Semmes-Weinstein单丝检查[SWME]、浅感觉、开-关法振动测试和定时法振动测试），并与神经传导研究的标准标准进行独立盲法评估比较。我们给出了每项测试的受试者操作特征（ROC）曲线、阳性和阴性似然比以及敏感性和特异性值。
四项简单筛查操作显示出相似的操作特征。ROC曲线分析的截断点显示，阳性或异常测试由施加的八个刺激中有五个错误反应表示。阴性或正常测试由施加的八个刺激中一个或更少错误反应表示。根据这些标准，开-关法振动测试、定时法振动测试、SWME和浅感觉测试的阳性似然比的点估计分别为26.6、18.5、10.2和9.2。阴性似然比 的点估计分别为0.33、0.51、0.34和0.50。筛查测试显示出相当的敏感性和特异性结果。10克SWME、浅感觉测试和开-关法振动测试速度快，每项测试大约需要60秒。定时振动测试耗时更长，解释更复杂。两项简单测试（如10克SWME和开-关法振动测试）的组合并没有为每个单独的筛查测试增加价值。
糖尿病神经病变的年度筛查应使用浅感觉测试、SWME或开-关法振动测试。报告的每种感觉模式的操作特征可应用于个体患者体格检查的阳性结果，以预测神经病变的可能性。
