Chen Jun, Yang Shuang-Bin, Liu Juanmei, Tang Zi-Hui
Department of Internal Medicine, The People's Hospital of Mengzi, Honghe, Yunnan China.
Department of Endocrinology and Metabolism, Shanghai Tongji Hospital, Tongji University School of Medicine, Rm 1520 Building 6th, No. 389 Xincun Road, Shanghai, 200065 China.
Diabetol Metab Syndr. 2015 Sep 10;7:74. doi: 10.1186/s13098-015-0070-z. eCollection 2015.
This study aimed to estimate the performance of diabetic cardiovascular autonomic neuropathy (DCAN) diagnostic tests in the absence of a gold standard.
The DCAN prevalence is rapidly growing in all populations worldwide. No document has been reported about diagnostic performance for DCAN based on short-term HRV without a gold standard.
We conducted a cross-sectional study to perform diagnostic test in Chinese diabetic patients. A dataset contained 56 subjects who completed both the short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence and the performance of each diagnostic test were possible using the Bayesian approach.
The HRV test had a high sensitivity (0.837 and 0.821 for independence model) and specificity (0.838 and 0.797 for dependence model) to DCAN. In addition, the non-inferiority test rejected the hypothesis that the performance of the HRV test was inferior to that of Ewing's test (P < 0.05). The estimated DCAN prevalence in our study sample was more than 0.400.
Our findings provided evidence that short-term HRV were used for the DCAN diagnostic test with a high sensitivity and specificity. ClinicalTrial.org ID: NCT02461381.
本研究旨在评估在缺乏金标准的情况下糖尿病心血管自主神经病变（DCAN）诊断测试的性能。
DCAN在全球所有人群中的患病率正在迅速上升。尚无关于在缺乏金标准的情况下基于短期心率变异性（HRV）对DCAN进行诊断性能的报道。
我们进行了一项横断面研究，对中国糖尿病患者进行诊断测试。一个数据集包含56名同时完成短期HRV测试和尤因氏测试的受试者。使用贝叶斯方法可以同时推断总体患病率和每种诊断测试的性能。
HRV测试对DCAN具有较高的敏感性（独立模型分别为0.837和0.821）和特异性（依赖模型分别为0.838和0.797）。此外，非劣效性检验拒绝了HRV测试性能不如尤因氏测试的假设（P < 0.05）。我们研究样本中DCAN的估计患病率超过0.400。
我们的研究结果提供了证据，表明短期HRV可用于DCAN诊断测试，具有较高的敏感性和特异性。ClinicalTrial.org标识符：NCT02461381。
