Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy.
Reliability and validity of a point-of-care sural nerve conduction device for identification of diabetic neuropathy.
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DOI：
10.1371/journal.pone.0086515
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Perkins BA
中科院分区：
文献类型：
--
作者：
Lee JA;Halpern EM;Lovblom LE;Yeung E;Bril V;Perkins BA
糖尿病感觉运动性多发性神经病(DSP)的确诊依赖于在专门诊所进行的标准神经传导研究(NCS)。我们探索了点护理设备(POCD)在非技术人员的DSP检测中的应用，并与标准数据库中观察到的诊断阈值进行了验证。44例1型和2型糖尿病患者接受了标准的NCS(参考方法)。两名非技术检查者使用POCD测量了腓肠神经幅度电位(SNAP)和传导速度(SNCV)。信度由组内相关系数(ICC)决定。有效性由Bland-Altman分析和接收器工作特性曲线确定。44例受试者(50%女性)，平均年龄56±18岁，平均SNAP和SNCV值分别为(8.0±8.6)µV和(41.5±8.2)m/S；SNAP和SNCV的重复性IC值分别为0.97和0.94，重复性IC值分别为0.83和0.79。−的平均偏置分别为SNA0.1±3.6µV和+8.4±6.4m/S。在识别年龄和身高标准化参考NCS值时，≤6µV的灵敏度为88%，特异度为94%；SNCV为≤48 m/S时，特异度为94%，灵敏度为82%。根据电生理学标准，这些阈值中的一个或多个的异常与识别DSP的95%的敏感性和71%的特异性相关。POCD显示出极好的可靠性和可接受的准确性。数字信号处理器识别阈值验证了已发表的POCD标准值。我们强调测量偏差的存在--尤其是SNCV--需要调整阈值以反映标准NC的阈值。
Confirmation of diabetic sensorimotor polyneuropathy (DSP) relies on standard nerve conduction studies (NCS) performed in specialized clinics. We explored the utility of a point-of-care device (POCD) for DSP detection by nontechnical personnel and a validation of diagnostic thresholds with those observed in a normative database. 44 subjects with type 1 and type 2 diabetes underwent standard NCS (reference method). Two nontechnical examiners measured sural nerve amplitude potential (SNAP) and conduction velocity (SNCV) using the POCD. Reliability was determined by intraclass correlation coefficients (ICC). Validity was determined by Bland-Altman analysis and receiver operating characteristic curves. The 44 subjects (50% female) with mean age 56±18 years had mean SNAP and SNCV of 8.0±8.6 µV and 41.5±8.2 m/s using standard NCS and 8.0±8.2 µV and 49.9±11.1 m/s using the POCD. Intrarater reproducibility ICC values were 0.97 for SNAP and 0.94 for SNCV while interrater reproducibility values were 0.83 and 0.79, respectively. Mean bias of the POCD was −0.1±3.6 µV for SNAP and +8.4±6.4 m/s for SNCV. A SNAP of ≤6 µV had 88% sensitivity and 94% specificity for identifying age-and height-standardized reference NCS values, while a SNCV of ≤48 m/s had 94% specificity and 82% sensitivity. Abnormality in one or more of these thresholds was associated with 95% sensitivity and 71% specificity for identification of DSP according to electrophysiological criteria. The POCD demonstrated excellent reliability and acceptable accuracy. Threshold values for DSP identification validated those of published POCD normative values. We emphasize the presence of measurement bias – particularly for SNCV – that requires adjustment of threshold values to reflect those of standard NCS.
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