Smartphone-Based versus Non-Invasive Automatic Oscillometric Brachial Cuff Blood Pressure Measurements: A Prospective Method Comparison Volunteer Study

Abstract

Introduction: Mobile health diagnostics have demonstrated effectiveness in detecting and managing chronic diseases. This method comparison study aims to assess the accuracy and precision of the previously evaluated OptiBP™ technology over a four-week study period. This device uses optical signals recorded by placing a patient’s fingertip on a smartphone’s camera to estimate blood pressure (BP). Methods: In adult participants without cardiac arrhythmias and minimal interarm blood pressure difference (systolic arterial pressure (SAP) < 15 mmHg or diastolic arterial pressure (DAP) < 10 mmHg), three pairs of 30 s BP measurements with the OptiBP™ (test method) were simultaneously compared using three pairs of measurements with the non-invasive oscillometric brachial cuff (reference method) on the opposite arm over a period of four consecutive weeks at a rate of two measurements per week (one in the morning and one in the afternoon). The agreement of BP values between the two technologies was analyzed using Bland–Altman and error grid analyses. The performance of the smartphone application was investigated using the International Organization for Standardization (ISO) definitions, which require the bias ± standard deviation (SD) between two technologies to be lower than 5 ± 8 mmHg. Results: Among the 65 eligible volunteers, 53 participants had adequate OptiBP™ BP values. In 12 patients, no OptiBP™ BP could be measured due to inadequate signals. Only nine participants had known chronic arterial hypertension and 76% of those patients were treated. The mean bias ± SD between both technologies was −1.4 mmHg ± 10.1 mmHg for systolic arterial pressure (SAP), 0.2 mmHg ± 6.5 mmHg for diastolic arterial pressure (DAP) and −0.5 mmHg ± 6.9 mmHg for mean arterial pressure (MAP). Error grid analyses indicated that 100% of the pairs of BP measurements were located in zones A (no risk) and B (low risk). Conclusions: In a cohort of volunteers, we observed an acceptable agreement between BP values obtained with the OptiBPTM and those obtained with the reference method over a four-week period. The OptiBPTM fulfills the ISO standards for MAP and DAP (but not SAP). The error grid analyses showed that 100% measurements were located in risk zones A and B. Despite the need for some technological improvements, this application may become an important tool to measure BP in the future.