Bayesian Estimation of Diagnostic Performance for Cardiovascular Autonomic Neuropathy

Bayesian Estimation of Diagnostic Performance of Short-term Heart Rate Variability for Cardiovascular Autonomic Neuropathy Without a Gold Standard

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.

Study Overview

• Status: Completed
• Conditions: Diagnostic Performance of Cardiovascular Autonomic Neuropathy
• Intervention / Treatment: Other: not intervention

Detailed Description

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 (Actual): 88

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200065
      • Shanghai Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals with inclusion and exclusion criteria were recruited from healthy examination centres to assess cardiovascular autonomic function using both the short-term heart rate variability and Ewing's tests.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dr.Tang's research group; This group included participants with completed both the short-term HRV test and Ewing's test.	Other: not intervention; This is a cross-sectional study for estimation of diagnostic performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	participants will be measured for the duration of outpatient stay, an expected average of two days

Collaborators and Investigators

• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
• Collaborators: Huashan Hospital
• Investigators: Principal Investigator: Zihui Tang, M.D and Ph.D, Shanghai Tongji Hospital, Tongji University School of Medicine

Publications and helpful links

General Publications

• Tang ZH, Zeng F, Yu X, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on baroreflex sensitivity in the absence of a gold standard. Int J Cardiol. 2014 Feb 15;171(3):e78-80. doi: 10.1016/j.ijcard.2013.11.100. Epub 2013 Dec 6. No abstract available.
• Zeng F, Tang ZH, Li Z, Yu X, Zhou L. Normative reference of short-term heart rate variability and estimation of cardiovascular autonomic neuropathy prevalence in Chinese people. J Endocrinol Invest. 2014 Apr;37(4):385-91. doi: 10.1007/s40618-013-0047-4. Epub 2014 Jan 9.
• Tang ZH, Wang L, Zeng F, Li Z, Yu X, Zhang K, Zhou L. Bayesian estimation of cardiovascular autonomic neuropathy diagnostic test based on short-term heart rate variability without a gold standard. BMJ Open. 2014 Oct 6;4(9):e005096. doi: 10.1136/bmjopen-2014-005096.
• Tang ZH, Zeng F, Ye K, Yu X, Zhou L. The analysis of a reference value for baroreflex sensitivity and cardiovascular autonomic neuropathy prevalence in a Chinese population. Eur J Med Res. 2014 Feb 12;19(1):8. doi: 10.1186/2047-783X-19-8.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 27, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: diagnostic performance; cardiovascular autonomic neuropathy; short-term heart rate variability; Bayesian estimation
• Additional Relevant MeSH Terms: Neuromuscular Diseases; Peripheral Nervous System Diseases; Nervous System Diseases
• Other Study ID Numbers: CANHRVB_Dr.Tang