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Abstract：
Background: There are many methods to diagnose diabetic autonomic neuropathy (DAN); however, often, the various methods do not provide consistent results. Even the two methods recommended by the American Diabetes Association (ADA) guidelines, Ewing\'s test and heart rate variability (HRV), sometimes give conflicting results. The purpose of this study was to evaluate the degree of agreement of the results of the Composite Autonomic Symptom Score 31 (COMPASS-31), skin sympathetic reaction (SSR) test, Ewing\'s test, and HRV in diagnosing DAN. Methods: Patients with type 2 diabetes were recruited and each received the COMPASS-31, SSR, Ewing\'s test, and HRV for the diagnosis of DAN. Patients were categorized as DAN(+) and DAN(-) by each of the tests. Kappa consistency tests were used to evaluate the agreement of diagnosing DAN between any two methods. Spearman\'s correlation test was used to evaluate the correlations of the severity of DAN between any two methods. Receiver operating characteristic (ROC) analyses were used to evaluate the diagnostic value and the cutoff value of each method. Results: A total of 126 type 2 diabetic patients were included in the study. The percentages of DAN(+) results by HRV, Ewing\'s test, COMPASS-31, and SSR were 61, 40, 35, and 33%, respectively. COMPASS-31 and Ewing\'s test had the best agreement for diagnosing DAN (κ = 0.512, p < 0.001). COMPASS-31 and Ewing\'s test also had the best correlation with respect to the severity of DAN (r = 0.587, p < 0.001). Ewing\'s test and COMPASS-31 had relatively good diagnostic values (AUC = 0.703 and 0.630, respectively) in the ROC analyses. Conclusions: COMPASS-31 and Ewing\'s test exhibit good diagnostic consistency and severity correlation for the diagnosis of DAN. Either test is suitable for the diagnosis of DAN and treatment follow-up.
摘要：
背景：有许多方法来诊断糖尿病自主神经病变（DAN）；然而，经常,各种方法不能提供一致的结果。即使是美国糖尿病协会（ADA）指南推荐的两种方法，尤因测试和心率变异性（HRV），有时会产生相互矛盾的结果。这项研究的目的是评估复合自主症状评分31（COMPASS-31）的结果的一致程度，皮肤交感神经反应（SSR）测试，尤因的测试，和HRV在诊断DAN中的作用。方法：招募2型糖尿病患者，每人接受COMPASS-31，SSR，尤因的测试，和HRV用于DAN的诊断。通过每个测试将患者分类为DAN(+)和DAN(-)。使用Kappa一致性检验来评估任何两种方法之间诊断DAN的一致性。采用Spearman相关性检验评价两种方法对DAN严重程度的相关性。使用受试者工作特征（ROC）分析来评估每种方法的诊断价值和截止值。结果：共纳入126例2型糖尿病患者。按HRV计算的DAN(+)结果的百分比，尤因的测试，COMPASS-31和SSR分别为61、40、35和33%，分别。COMPASS-31和Ewing检验对诊断DAN具有最佳的一致性（κ=0.512，p<0.001）。COMPASS-31和Ewing检验与DAN的严重程度也具有最佳相关性（r=0.587，p<0.001）。在ROC分析中，Ewing检验和COMPASS-31具有相对较好的诊断价值（AUC分别为0.703和0.630）。结论：COMPASS-31和Ewing\'s检验对DAN的诊断具有良好的诊断一致性和严重程度相关性。任何一种测试都适用于DAN的诊断和治疗随访。
