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

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 OptiBP TM and those obtained with the reference method over a four-week period. The OptiBP TM 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.