VALIDATION OF THE SMARTPHONE BLOOD PRESSURE MEASUREMENT SOLUTION OPTIBP™ TO TRACK BLOOD PRESSURE CHANGES IN PREGNANT WOMEN

Abstract

Objective: Hypertensive disorders present significant morbidity and mortality during pregnancy. While ambulatory blood pressure measurement remains the standard of care for normotensive women, self-monitoring at home is increasingly prevalent. The widespread use of smartphones worldwide has sparked interest in mobile applications that leverage the built-in hardware for blood pressure estimation, yet few trials have assessed their accuracy. Design and method: This prospective, longitudinal and monocentric study evaluated the accuracy of the OptiBP algorithm against standard oscillometric blood pressure measurements in a sample of pregnant women. Patients scheduled for elective caesarean sections were enrolled during the preoperative anesthesia consultations. Paired blood pressure measurements using OptiBP and the reference method were obtained at multiple time-points in late pregnancy and the post-partum period. Agreement between methods was assessed using the AAMI/ESH/ISO 81060-2:2018 standard thresholds of 5±8 mmHg for mean ± standard deviation of the error (criterion 1) and patient-specific standard deviation of the mean error (criterion 2) and represented graphically by Bland-Altman scatterplots. Results: Twenty-four women were enrolled of which 15 completed the protocol, yielding 166 total valid measurement pairs. Mean and standard deviation of the error were -0.74 ± 8.38 and 0.99±6.88, and the patient-specific standard deviation of the mean error was 5.84 and 3.36, for SBP and DBP respectively. Conclusions: Compared with blood pressure measure with an oscillometric device, OptiBP's blood pressure estimates meet the AAMI/ESH/ISO 81060-2:2018 criteria for DBP.