Reliability assessment for pulse wave measurement using artificial pulse generator

Abstract

This study aimed to assess intrinsic reliabilities of devices for pulse wave measurement (PWM). An artificial pulse generator system was constructed to create a periodic pulse wave. The stability of the periodic output was tested by the DP103 pressure transducer. The pulse generator system was then used to evaluate the TD01C system. Test–re-test and inter-device reliability assessments were conducted on the TD01C system. First, 11 harmonic components of the pulse wave were calculated using Fourier series analysis. For each harmonic component, coefficient of variation (CV), intra-class correlation coefficient (ICC) and Bland-Altman plot were used to determine the degree of reliability of the TD01C system. In addition, device exclusion criteria were pre-specified to improve consistency of devices. The artificial pulse generator system was stable to evaluate intrinsic reliabilities of devices for PWM (ICCs > 0.95, p < 0.001). TD01C was reliable for repeated measurements (ICCs of test–re-test reliability > 0.95, p < 0.001; CVs all < 3%). Device exclusion criteria successfully excluded the device with defect; therefore, the criteria reduced inter-device CVs of harmonics and improved consistency of the selected devices for all harmonic components. This study confirmed the feasibility of intrinsic reliability assessment of devices for PWM using an artificial pulse generator system. Moreover, potential novel findings on the assessment combined with device exclusion criteria could be a useful method to select the measuring devices and to evaluate the qualities of them in PWM.