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，对于皮肤和较轻皮肤的患者，医疗设备的准确性较低。这个问题可能会对医生对如何治疗这些患者做出正确决定的能力产生负面影响，从而导致皮肤较深的患者的健康状况恶化。大多数专家认为，这种作用的主要原因是黑色素在皮肤顶层吸收光。人群中皮肤中黑色素含量的差异很大。称为黑色素计的仪器可以测量与皮肤中黑色素量有关的变量。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种群医疗设备准确性的影响。该建议将开发出与不同量的黑色素和血液模仿皮肤的材料，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用黑色素计获得的数据的影响。该项目可能会改善方法，以确保医疗设备对所有种族和皮肤类型的患者都安全有效。该项目的结果将纳入加利福尼亚大学欧文分校的课程中，以确定健康成果的差异，以说明如何以各种不同患者的群体同样准确地开发和验证技术。在临床健康环境和个人健康环境中，在整个肤色范围内保持生物良好技术的鲁棒性是至关重要的。在过去的二十年中，大量研究已经确定了从脑氧仪到光声成像仪的生物流通设备中的种族差异。这些差异可能会对临床决策产生不利影响，从而导致皮肤较深的患者的健康状况恶化。大多数专家认为，这种作用的主要原因是表皮黑色素的强烈，不同的吸收。在整个人群中的浓度差异很大。为了确定对设备的影响的大小，必须准确确定黑色素含量与设备输出/精度之间的相关性。先前的研究使用了主观方法，包括对种族的自我认同和Fitzpatrick光型量表来评估主题色素沉着。但是，基于光学测量结果的客观，定量和良好的方法可能会提供更精确，更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组严格的合成组织模拟幻象来实现这一目标，并将这些幻影用作校准标准，以系统地表征商业（非FDA批准/清除）黑色素测量仪，以测量皮肤色素沉着。验证这些商业设备的产出与一组良好的组织模型集合，这些模型既模拟黑色素含量和混杂的组织因素（例如，血红蛋白，组织散射）将为确定黑色素仪的可信度提供至关重要的基本步骤影响审查标准。