An automated human–machine interaction system enhances standardization, accuracy and efficiency in cardiovascular autonomic evaluation: A multicenter, open-label, paired design study

• Published in: Journal of translational internal medicine Vol. 13; no. 2; pp. 170 - 179
• Main Authors: Fu, Xiaoying, Liu, Qunzhi, Pan, Qi, Peng, Rong, Huang, Zeshan, Guo, Xingyuan, Tan, Mingkai, Li, Qiang, Jia, Lijing, Li, Yanbing, Liu, Liehua, Kuang, Jian, Wu, Wen, Guo, Lixin
• Format: Journal Article
• Language: English
• Published: Poland De Gruyter 01.04.2025; De Gruyter Poland
• Subjects: Accuracy; Automation; Blood pressure; cardiovascular autonomic neuropathy; cardiovascular autonomic reflex tests; Diabetes; Efficiency; Electrocardiography; Feedback; Heart rate; heart rate variability; human‒machine interaction; Medical equipment; Methods; Original; Reproducibility; wireless; China; Shenzhen China; wireless; human‒machine interaction; cardiovascular autonomic reflex tests; heart rate variability; diabetes; cardiovascular autonomic neuropathy
• ISSN: 2224-4018; 2450-131X; 2224-4018
• DOI: 10.1515/jtim-2025-0013

The conventional diagnostic process for cardiovascular autonomic neuropathy (CAN) is often time-consuming and lacks standardization. The Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System is the first intelligent device designed for CAN diagnosis, featuring wireless wearable modules and human‒computer interaction. This study aims to evaluate the accuracy and eficiency of the novel device. A two-part, paired-design multicenter study involving a total of 200 subjects (122 with diabetes) from three centers was conducted. Cardiovascular autonomic reflex tests (CARTs) and 5-min heart rate variability (HRV) analyses were performed via the study device. Concurrent manual measurements with physician diagnoses and nonstandardized conventional methods served as controls in Part I and Part II, respectively. In Part I, the study device diagnosed 19.3% (29/150) of the subjects with CAN, demonstrating 96.6% sensitivity and 100% specificity. There was excellent agreement with the physician's CAN diagnosis for CARTs (Cohen's kappa of 0.979, < 0.001) and with the control device for HRV parameters (intraclass correlations [ICCs] > 0.9). Part II showed weak to moderate intermethod correlations with the nonstandardized conventional method (ICCs = 0.193‒0.632). Repeated tests revealed high reproducibility (coefficients of variation = 3%‒20%). The investigational device required only one examiner to perform a standardized assessment and saved 33 minutes compared with manual methods. The proposed system provides eficient and standardized testing with excellent accuracy and reproducibility for CAN assessment. This novel device will facilitate the evaluation of therapeutic efficacy and promote streamlined clinical workflows.