Vasudevan Sandhya, Vogt William C, Weininger Sandy, Pfefer T Joshua
Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Commun Med (Lond). 2024 Jul 11;4(1):138. doi: 10.1038/s43856-024-00550-7.
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.
脉搏血氧测定法能够对动脉血氧水平进行实时、无创监测。然而，结果可能因肤色而异，因此在临床验证研究中检测差异需要准确测量皮肤色素沉着。最近的临床研究使用了自我报告的颜色、种族/民族等主观方法对皮肤进行分类。基于光学反射率的黑色素仪可能提供一种更有效、客观的方法来评估色素沉着。在此，我们回顾黑色素测定方法，并评估支持其作为临床研究工具使用的证据。我们比较性能数据，包括重复性、对混杂因素的稳健性，并将不同设备相互比较，与主观方法以及高质量参考标准进行比较。最后，我们提出评估黑色素仪的最佳实践，并讨论可能提高准确性的替代光学方法。虽然有证据表明黑色素仪比主观方法性能更优，但我们鼓励进行更多研究和标准化工作，因为临床研究需要这些来确保结果的一致性和可靠性。
