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，与浅色皮肤患者相比，医疗设备对于深色皮肤患者的准确度可能较低。这个问题可能会对医生就如何治疗这些患者做出正确决定的能力产生负面影响，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皮肤表层黑色素吸收光。不同人群皮肤中黑色素的含量存在很大差异。黑色素测量仪可以测量与皮肤中黑色素含量相关的变量。使用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设备准确性的影响。该提案将开发具有不同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。该项目可能会改进方法，确保医疗设备对所有种族和皮肤类型的患者安全有效。该项目的结果将被纳入加州大学欧文分校关于识别健康结果差异的课程中，以说明如何以在不同患者群体中同样准确的方式开发和验证技术。确保生物光子技术在整个领域的稳健性各种肤色对于临床环境和个人健康监测环境中的医疗保健公平性至关重要。在过去的二十年中，大量研究已经确定了从脑血氧计到光声成像仪的生物光子设备中的种族差异。这些差异可能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表皮黑色素的强烈、光谱变化的吸收；其浓度在人群中差异很大。为了确定对设备的影响程度，必须准确确定黑色素含量和设备输出/准确性之间的相关性。先前的研究使用主观方法，包括种族自我识别和菲茨帕特里克照型量表来评估受试者色素沉着。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模型并使用这些模型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（未经 FDA 批准/许可）黑素计来实现这一目标。根据一组模拟黑色素含量和混杂组织因素（例如血红蛋白、组织散射）的良好表征的组织模型来验证这些商业设备的输出，将为建立黑素计作为监管科学工具的可信度提供关键的基础步骤该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。