Impact of Skin Pigmentation on Pulse Oximetry Blood Oxygenation and Wearable Pulse Rate Accuracy: Systematic Review and Meta-Analysis.

Autor: Singh S; University of Michigan Medical School, Ann Arbor, MI, United States., Bennett MR; Verily Life Sciences LLC, South San Francisco, CA, United States., Chen C; Verily Life Sciences LLC, South San Francisco, CA, United States., Shin S; Verily Life Sciences LLC, South San Francisco, CA, United States., Ghanbari H; University of Michigan Medical School, Ann Arbor, MI, United States., Nelson BW; Verily Life Sciences LLC, South San Francisco, CA, United States.; Division of Digital Psychiatry, Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.
Jazyk: angličtina
Zdroj: Journal of medical Internet research [J Med Internet Res] 2024 Oct 10; Vol. 26, pp. e62769. Date of Electronic Publication: 2024 Oct 10.
DOI: 10.2196/62769
Abstrakt: Background: Photoplethysmography (PPG) is a technology routinely used in clinical practice to assess blood oxygenation (SpO 2 ) and pulse rate (PR). Skin pigmentation may influence accuracy, leading to health outcomes disparities.
Objective: This systematic review and meta-analysis primarily aimed to evaluate the accuracy of PPG-derived SpO 2 and PR by skin pigmentation. Secondarily, we aimed to evaluate statistical biases and the clinical relevance of PPG-derived SpO 2 and PR according to skin pigmentation.
Methods: We identified 23 pulse oximetry studies (n=59,684; 197,353 paired SpO 2 -arterial blood observations) and 4 wearable PR studies (n=176; 140,771 paired PPG-electrocardiography observations). We evaluated accuracy according to skin pigmentation group by comparing SpO 2 accuracy root-mean-square values to the regulatory threshold of 3% and PR 95% limits of agreement values to +5 or -5 beats per minute (bpm), according to the standards of the American National Standards Institute, Association for the Advancement of Medical Instrumentation, and the International Electrotechnical Commission. We evaluated biases and clinical relevance using mean bias and 95% CI.
Results: For SpO 2 , accuracy root-mean-square values were 3.96%, 4.71%, and 4.15%, and pooled mean biases were 0.70% (95% CI 0.17%-1.22%), 0.27% (95% CI -0.64% to 1.19%), and 1.27% (95% CI 0.58%-1.95%) for light, medium, and dark pigmentation, respectively. For PR, 95% limits of agreement values were from -16.02 to 13.54, from -18.62 to 16.84, and from -33.69 to 32.54, and pooled mean biases were -1.24 (95% CI -5.31 to 2.83) bpm, -0.89 (95% CI -3.70 to 1.93) bpm, and -0.57 (95% CI -9.44 to 8.29) bpm for light, medium, and dark pigmentation, respectively.
Conclusions: SpO 2 and PR measurements may be inaccurate across all skin pigmentation groups, breaching U.S. Food and Drug Administration guidance and industry standard thresholds. Pulse oximeters significantly overestimate SpO 2 for both light and dark skin pigmentation, but this overestimation may not be clinically relevant. PRs obtained from wearables exhibit no statistically or clinically significant bias based on skin pigmentation.
(©Sanidhya Singh, Miles Romney Bennett, Chen Chen, Sooyoon Shin, Hamid Ghanbari, Benjamin W Nelson. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 10.10.2024.)
Databáze: MEDLINE
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