Bayesian Estimation of Diagnostic Performance for Cardiovascular Autonomic Neuropathy

Shanghai Tongji Hospital, Tongji University School of Medicine88 enrolled

Overview

This study aimed to evaluate the reference values for the short-term heart rate variable (HRV), estimate the performance of cardiovascular autonomic neuropathy (CAN) diagnostic tests in the absence of a gold standard, and assess CAN prevalence in our cross-sectional dataset.

The CAN prevalence is rapidly growing in all populations worldwide. No document has been reported about normal reference values for CAN using this test in the Chinese population. This study aimed to evaluate the reference values for the short-term HRV in a large cross-sectional dataset, and to estimate sensitivities and specificities of CAN diagnostic tests using the Bayesian approach, in the absence of a gold standard in another independence dataset. Finally, CAN prevalence was estimated in the investigators' cross-sectional dataset. Firstly, the reference the values for the short-term HRV were calculated in the investigators' previous study (including 371 healthy subjects). This study dataset contained 88 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

Conditions

Diagnostic Performance of Cardiovascular Autonomic Neuropathy

Interventions

not interventionOTHER

This is a cross-sectional study for estimation of diagnostic performance.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Survey participants with undiagnosed CAN, aged 30-80 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 11. 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.

Locations (1)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Cardiovascular autonomic function evaluate by short-term heart rate variability test

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

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

Cardiovascular autonomic function evaluate by Ewing's test

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

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

Data from ClinicalTrials.gov

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