Bayesian Estimation of Diagnostic Performance of Diabetic Cardiovascular Autonomic Neuropathy Without a Gold Standard

Shanghai Tongji Hospital, Tongji University School of Medicine200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Diabetic Cardiovascular Autonomic Neuropathy (DCAN)

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Survey diabetic participants with undiagnosed CAN, aged 30-90 years, were included in this study. Exclusion Criteria: * 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: 1. history or findings of arrhythmia, and hyperthyroidism or hypothyroidism; 2. pregnancy or lactation; and/or 3. serious hepatic or renal dysfunctions.

Outcomes

Primary Outcomes

Diabetic cardiovascular autonomic function evaluate by short-term heart rate variability test

Both short-term heart rate variability and Ewing's test measure diabetic cardiovascular autonomic function

Time frame: participants will be measured for the duration of outpatient stay, an expected average of two days

Diabetic cardiovascular autonomic function evaluate by Ewing's test

Both short-term heart rate variability and Ewing's test measure cardiovascular autonomic function