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

NSF/FDA SiR：黑素测定法作为生物光子设备种族差异临床评估定量工具的验证和标准化

• 批准号: 2326485
• 负责人: Robert Wilson
• 金额: $ 20万
• 依托单位: University of California-Irvine
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-10-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2326485&HistoricalAwards=false
• 关键词: NSF; FDA; SiR; Validation; Standardization

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.

最近的研究表明，对于肤色较深的患者，医疗设备的准确性可能不如浅色皮肤的患者。这个问题会对医生做出正确治疗这些患者的决定产生负面影响，导致深色皮肤患者的健康状况更差。大多数专家认为，这种现象的主要原因是皮肤表层黑色素对光线的吸收。不同人群皮肤中黑色素的含量差异很大。被称为黑色素计的仪器可以测量与皮肤中黑色素含量相关的变量。使用来自黑色素计的数据可能有助于正确地解释黑色素对不同人群中医疗设备准确性的影响。该提案将开发具有不同数量黑色素和血液的模拟皮肤的材料，并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。这个项目可能会导致改进的方法，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。该项目的成果将被纳入加州大学欧文分校（University of California Irvine）关于识别健康结果差异的课程，以说明如何在不同的患者群体中以同样准确的方式开发和验证技术。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设置中的医疗公平至关重要。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。这些差异会对临床决策产生不利影响，导致深色皮肤患者的健康结果更差。大多数专家认为，这种效应的主要原因是对表皮黑色素的强烈的、光谱变化的吸收；其浓度在人群中差别很大。为了确定对设备的影响程度，必须准确地确定黑色素含量与设备输出/精度之间的相关性。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、定量和标准化的方法可能为分离表皮黑色素的影响提供更精确和有效的方法。PI和合作者将通过构建一套严格的合成组织模拟模型来实现这一目标，并使用这些模型作为校准标准，系统地表征用于测量皮肤色素沉着的商用（非fda批准/清除）黑色素计。验证这些商用设备的输出，对照一组具有良好特征的组织模型，模拟黑色素含量和混杂组织因素（例如，血红蛋白，组织散射），将为建立黑色素计作为调节科学工具的可信度提供关键的基础步骤。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。