Melanometry for objective evaluation of skin pigmentation in pulse oximetry studies.


Journal

Communications medicine
ISSN: 2730-664X
Titre abrégé: Commun Med (Lond)
Pays: England
ID NLM: 9918250414506676

Informations de publication

Date de publication:
11 Jul 2024
Historique:
received: 09 03 2023
accepted: 11 06 2024
medline: 12 7 2024
pubmed: 12 7 2024
entrez: 11 7 2024
Statut: epublish

Résumé

Pulse oximetry enables real-time, noninvasive monitoring of arterial blood oxygen levels. However, results can vary with skin color, thus detecting disparities during clinical validation studies requires an accurate measure of skin pigmentation. Recent clinical studies have used subjective methods such as self-reported color, race/ethnicity to categorize skin. Melanometers based on optical reflectance may offer a more effective, objective approach to assess pigmentation. Here, we review melanometry approaches and assess evidence supporting their use as clinical research tools. We compare performance data, including repeatability, robustness to confounders, and compare devices to each other, to subjective methods, and high-quality references. Finally, we propose best practices for evaluating melanometers and discuss alternate optical approaches that may improve accuracy. Whilst evidence indicates that melanometers can provide superior performance to subjective approaches, we encourage additional research and standardization efforts, as these are needed to ensure consistent and reliable results in clinical studies.

Identifiants

pubmed: 38992188
doi: 10.1038/s43856-024-00550-7
pii: 10.1038/s43856-024-00550-7
doi:

Types de publication

Journal Article Review

Langues

eng

Pagination

138

Informations de copyright

© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.

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Auteurs

Sandhya Vasudevan (S)

Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. sandhya.vasudevan@fda.hhs.gov.

William C Vogt (WC)

Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

Sandy Weininger (S)

Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

T Joshua Pfefer (TJ)

Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

Classifications MeSH