NSF/FDA SiR: Validation and Standardization of Melanometry as a Quantitative Tool for Clinical Evaluation of Racial Disparities in Biophotonic Devices

最近的研究表明，医疗设备对肤色较深的患者的准确性可能低于肤色较浅的患者。这个问题可能会对医生做出正确决定如何治疗这些患者的能力产生负面影响，导致皮肤较黑的患者的健康状况更差。大多数专家认为，这种效果的主要原因是皮肤顶层的黑色素对光线的吸收。不同人群皮肤中黑色素的含量有很大差异。称为黑色素计的仪器可以测量与皮肤中黑色素数量相关的变量。使用来自黑色素计的数据可能有助于正确解释黑色素对不同人群中医疗器械准确性的影响。该提案将开发具有不同黑色素和血液量的模拟皮肤的材料，并使用黑色素计测量这些材料，以更好地了解黑色素和血液对黑色素计获得的数据的影响。该项目可能导致改进方法，以确保医疗设备对所有种族和皮肤类型的患者都是安全有效的。该项目的结果将被纳入加州尔湾大学关于识别健康结果差异的课程中，以说明如何开发和验证技术，使其在不同患者群体中同样准确。确保生物光子技术在所有肤色范围内的稳健性对于临床环境和个人健康监测环境中的医疗平等至关重要。在过去的二十年里，许多研究已经确定了生物光子设备的种族差异，从脑血氧仪到光声成像仪。这些差异可能会对临床决策产生不利影响，导致皮肤较深的患者的健康状况更差。大多数专家认为，这种影响的主要原因是表皮黑色素的强烈，光谱变化的吸收;其浓度在人群中有很大差异。为了确定对器械的影响程度，必须准确确定黑色素含量与器械输出/准确度之间的相关性。先前的研究使用主观方法，包括种族的自我识别和菲茨帕特里克光型量表来评估受试者的色素沉着。然而，基于光学测量的客观、定量和标准化方法可能提供更精确和有效的方法来隔离表皮黑色素的影响。PI和合作者将通过构建一套严格的合成组织模拟体模并使用这些体模作为校准标准来系统地表征用于测量皮肤色素沉着的商业（非FDA批准/许可）黑色素计来实现这一目标。根据一组充分表征的组织模型验证这些商业器械的输出，这些模型模拟黑色素含量和混淆组织因素（例如，血红蛋白，组织散射）将提供一个关键的基本步骤，在建立信誉的黑色素计作为监管科学工具。这一奖项反映了NSF的法定使命，并已被认为是值得支持的评估使用基金会的智力价值和更广泛的影响审查标准。

Recent studies have shown that medical devices can be less accurate for patients with darker versus lighter skin. This problem can negatively affect the ability of doctors to make correct decisions about how to treat these patients, leading to worse health outcomes for patients with darker skin. Most experts believe that the primary cause of this effect is the absorption of light by melanin in the top layer of the skin. There are wide variations in the amount of melanin in the skin among the population. Instruments called melanometers can measure variables related to the amount of melanin in the skin. Using data from melanometers may help to properly account for the effect of melanin on the accuracy of medical devices in diverse populations. This proposal will develop materials that mimic skin with different amounts of melanin and blood and measure these materials with melanometers to better understand the effects of melanin and blood on the data obtained with melanometers. This project may lead to improved methods for making sure that medical devices are safe and effective for patients of all races and skin types. Results of this project will be incorporated into courses at the University of California Irvine on identifying disparities in health outcomes to illustrate how technologies can be developed and validated in a way that is equally accurate across diverse groups of patients.Ensuring robustness of biophotonic technologies across the full range of skin colors is crucial for healthcare equity in clinical environments and personal health monitoring settings. Over the past two decades, numerous studies have identified racial disparities in biophotonic devices, from cerebral oximeters to photoacoustic imagers. These discrepancies can adversely impact clinical decision making, leading to worse health outcomes for patients with darker skin. Most experts believe that the primary cause of this effect is the intense, spectrally varying absorption of epidermal melanin; the concentration of which varies considerably across the population. To determine the magnitude of impact on a device, one must accurately determine the correlation between melanin content and device outputs/accuracy. Prior studies have used subjective methods, including self-identification of race and the Fitzpatrick phototype scale to assess subject pigmentation. However, objective, quantitative, and well-standardized methods based on optical measurements may provide a more precise and effective way to isolate the impact of epidermal melanin. The PI and collaborators will pursue this goal via constructing a rigorous set of synthetic tissue-simulating phantoms and using these phantoms as calibration standards to systematically characterize commercial (non-FDA-approved/cleared) melanometers for measuring skin pigmentation. Validating the outputs of these commercial devices against a well-characterized set of tissue models that simulate both melanin content and confounding tissue factors (e.g., hemoglobin, tissue scattering) will provide a critical fundamental step forward in establishing the credibility of melanometers as regulatory science tools.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.