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This study was aimed to establish a standard protocol and to quantitatively assess the reliability of harmonic analysis of the radial pulse wave measured by a harmonic wave analyzer (TD01C system). Both intraobserver and interobserver assessments were conducted to investigate whether the values of harmonics are stable in successive measurements. An intraclass correlation coefficient (ICC) and a Bland-Altman plot were used for this purpose. For the reliability assessments of the intraobserver and the interobserver, 22 subjects (mean age 45 ± 14 years; 14 males and 8 females) were enrolled. The first eleven harmonics of the radial pulse wave presented excellent repeatability (ICCs > 0.9 and p <; 0.001) for the intraobserver assessment and high reproducibility (ICCs range from 0.83 to 0.96 and p <; 0.001) for the interobserver assessment. The Bland-Altman plot indicated that more than 90% of harmonic values fell within two standard deviations of the mean difference. Thus, we concluded that the harmonic analysis of the radial pulse wave using the TD01C system is a feasible and reliable method to assess a hemodynamic characteristic in clinical trial.

Development of a Standard Protocol for the Harmonic Analysis of Radial Pulse Wave and Assessing Its Reliability in Healthy Humans