Validação de relógio inteligente de baixo custo para aferição de pressão arterial

Abstract

The aim of the study was to evaluate the accuracy of blood pressure (BP) measurement by two low-cost smartwatch models that use photoplethysmography (FTP), compared to a standard cuff device. For the method the devices Smart Wristband HW12 and B57-Heroband.3 devices (test devices (TD)) were compared to the OMRON HEM-7122 oscillometric sphygmomanometer (reference device (RD)), according to the AAMI/ESH/ISO 81060-2:2018 protocol. A total of 93 participants were included. Among the main results were: the mean difference between the TD and RD measurements was adequate (i.e., <5 mmHg) for both TD, regarding systolic blood pressure (SBP), and only for the HW12, regarding diastolic blood pressure (DBP); the standard deviation of the differences was >8 mmHg for both TD, both for SBP and DBP, indicating a high degree of measurement inaccuracy. The TD overestimated low BP values and underestimated high levels, as demonstrated in the Bland-Altman plots and corroborated by Pearson's correlation between the differences (TD-RD) and the means of the measurements, with negative and statistically significant coefficients. No device met the required validation criteria and was considered inadequate for diagnosis and/or monitoring of hypertensive patients.