Equity-Driven Sensing System for Measuring Skin Tone-Calibrated Peripheral Blood Oxygen Saturation (OptoBeat): Development, Design, and Evaluation Study.

Background: Many commodity pulse oximeters are insufficiently calibrated for patients with darker skin. We demonstrate a quantitative measurement of this disparity in peripheral blood oxygen saturation (SpO) with a controlled experiment. To mitigate this, we present OptoBeat, an ultra-low-cost smartphone-based optical sensing system that captures SpO and heart rate while calibrating for differences in skin tone. Our sensing system can be constructed from commodity components and 3D-printed clips for approximately US $1. In our experiments, we demonstrate the efficacy of the OptoBeat system, which can measure SpO within 1% of the ground truth in levels as low as 75%.

Objective: The objective of this work is to test the following hypotheses and implement an ultra-low-cost smartphone adapter to measure SpO: skin tone has a significant effect on pulse oximeter measurements (hypothesis 1), images of skin tone can be used to calibrate pulse oximeter error (hypothesis 2), and SpO can be measured with a smartphone camera using the screen as a light source (hypothesis 3).

Methods: Synthetic skin with the same optical properties as human skin was used in ex vivo experiments. A skin tone scale was placed in images for calibration and ground truth. To achieve a wide range of SpO for measurement, we reoxygenated sheep blood and pumped it through synthetic arteries. A custom optical system was connected from the smartphone screen (flashing red and blue) to the analyte and into the phone's camera for measurement.

Results: The 3 skin tones were accurately classified according to the Fitzpatrick scale as types 2, 3, and 5. Classification was performed using the Euclidean distance between the measured red, green, and blue values. Traditional pulse oximeter measurements (n=2000) showed significant differences between skin tones in both alternating current and direct current measurements using ANOVA (direct current: F=3.1170 × 10, P<.01; alternating current: F=8.07 × 10, P<.01). Continuous SpO measurements (n=400; 10-second samples, 67 minutes total) from 95% to 75% were captured using OptoBeat in an ex vivo experiment. The accuracy was measured to be within 1% of the ground truth via quadratic support vector machine regression and 10-fold cross-validation (R=0.97, root mean square error=0.7, mean square error=0.49, and mean absolute error=0.5). In the human-participant proof-of-concept experiment (N=3; samples=3 × N, duration=20-30 seconds per sample), SpO measurements were accurate to within 0.5% of the ground truth, and pulse rate measurements were accurate to within 1.7% of the ground truth.

Conclusions: In this work, we demonstrate that skin tone has a significant effect on SpO measurements and the design and evaluation of OptoBeat. The ultra-low-cost OptoBeat system enables smartphones to classify skin tone for calibration, reliably measure SpO as low as 75%, and normalize to avoid skin tone-based bias.