Bayesian Estimation of Diagnostic Performance of Short-term Heart Rate Variability for Diabetic Cardiovascular Autonomic Neuropathy in the Absence of a Gold Standard
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diabetic cardiovascular autonomic function evaluate by short-term heart rate variability test
研究概览
简要总结
This study aimed to estimate sensitivities and specificities of diabetic cardiovascular autonomic neuropathy (DCAN) diagnostic tests using the Bayesian approach without a gold standard in another independence dataset.The reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 200 diabetic patients 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 without a gold standard.
详细描述
The CAN prevalence is rapidly growing in all populations worldwide. No document has been reported diagnostic performance of short-term heart rate variability (HRV) for diabetic cardiovascular autonomic neuropathy (DCAN) in the Chinese population. This study aimed to estimate sensitivities and specificities of DCAN diagnostic tests using the Bayesian approach, in the absence of a gold standard in another independence dataset.The reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 200 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 without a gold standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Survey diabetic participants with undiagnosed CAN, aged 30-90 years, were included in this study.
排除标准
- •Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function. Briefly, the exclusion criteria were as follows:
- •history or findings of arrhythmia, and hyperthyroidism or hypothyroidism;
- •pregnancy or lactation; and/or
- •serious hepatic or renal dysfunctions.
结局指标
主要结局
Diabetic cardiovascular autonomic function evaluate by short-term heart rate variability test
时间窗: participants will be measured for the duration of outpatient stay, an expected average of two days
Both short-term heart rate variability and Ewing's test measure diabetic cardiovascular autonomic function
Diabetic cardiovascular autonomic function evaluate by Ewing's test
时间窗: participants will be measured for the duration of outpatient stay, an expected average of two days
Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function
次要结局
未报告次要终点
研究者
Zihui Tang
M.D and Ph.D
Shanghai Tongji Hospital, Tongji University School of Medicine