Reducing Errors in the Diagnosis of Melanoma and Melanocytic Lesions

 描述(申请人提供)：拟议的研究将有助于提高病理学家诊断黑色素瘤和其他黑素细胞病变的准确性。黑色素瘤的发病率上升速度比其他任何癌症都快，到2015年，每50名美国成年人中就有1人被诊断出患有黑色素瘤。黑色素瘤的诊断是组织病理学中最具挑战性的领域之一，因为皮肤活检具有复杂的结构结构，必须作为诊断的一部分进行评估；其他类型的活检只需要细胞水平的评估。我们之前的工作揭示了黑色素瘤诊断中的大量和频繁的错误：病理学家在高达60%的原位黑色素瘤和早期侵袭性黑色素瘤病例中存在分歧。误诊可能会对患者造成重大伤害。鉴于进行皮肤活检的数量不断增加，这些错误对公共健康的影响可能会越来越大-据估计，目前仅每年就有1/10的美国老年人接受皮肤活组织检查。新兴的数字化载玻片技术(通过将皮肤活检的玻璃片数字化而产生)正在扩展到病理学教育和董事会认证测试。由于数字化载玻片能够从任何计算机进行远程诊断，因此人们对采用数字化载玻片进行主要诊断和/或第二意见的兴趣日益浓厚。FDA目前认为数字化幻灯片是III级医疗设备，在批准广泛临床使用之前需要额外的数据。在我们工作的第一阶段(目标1)，我们将比较240名美国病理学家对黑素细胞病变的数字化和玻片诊断的准确性。验证数字化载玻片对于确保基于数字化载玻片的诊断性能至少与玻璃载玻片和光学显微镜的诊断性能相当至关重要。在第二阶段，相同的病理学家将重新诊断相同的病例(在一段时间后)，尽管他们不知道它们是相同的病例。对于第二阶段的一些病例，病理学家将获得与第一阶段不同的病理学家的诊断。使用这两个阶段的数据，AIM 2将量化与向咨询病理学家提供先前诊断相关的偏差。数字媒体也为研究病理学家错误的原因提供了新的机会。Aim 3将评估另外60名病理学家在通过新的眼球跟踪技术诊断数字化幻灯片时的视觉搜索行为。我们的工作将最终基于目标1-3的结果来评估战略，以通过量化获得第二意见的潜在影响来减少诊断错误(目标4)。还没有做出实质性的尝试来了解黑色素瘤诊断中的错误或评估可能的解决方案。我们的研究将找出诊断错误的根本原因，并指导未来教育和质量改进工作的设计。这些数据对于设计和实施策略以减轻患者和医疗保健系统的诊断错误负担、将数字化幻灯片安全地集成到 临床工作流程，并改进病理实践。

 DESCRIPTION (provided by applicant): The proposed research will help to improve the accuracy of pathologists diagnosing melanoma and other melanocytic lesions. The incidence of melanoma is rising faster than any other cancer, and ~1 in 50 U.S. adults will be diagnosed with melanoma in 2015. Melanoma diagnosis is among the most challenging areas of histopathology because skin biopsies have a complex architectural structure that must be evaluated as part of the diagnosis; other types of biopsies require only cellular level assessment. Our previous work revealed substantial and frequent errors in diagnosis of melanoma: pathologists disagree in up to 60% of melanoma in situ and early stage invasive melanoma cases. Misdiagnosis can lead to substantial patient harm. The impact of these errors on public health may be growing given the increasing number of skin biopsies performed-an estimated 1 in 10 older U.S. adults currently undergo a skin biopsy procedure each year alone. The emerging technology of digitized slides (created by digitizing glass slides of skin biopsies) is expanding into pathology education and board certification testing. As digitized slides enable remote diagnosis from any computer, there is increasing interest in adopting digitized slides for primary diagnosis and/or second opinions. The FDA currently considers digitized slides a class III medical device, requiring additional data before approval for broad clinical use. We will compare the accuracy of 240 U.S. pathologists' diagnoses of digitized versus glass slides of melanocytic lesions in Phase I of our work (Aim 1). Validation of digitized slides is crucial to ensure that diagnostic performance based on digitized slides is at least equivalent to that of glass slides and light microscopy. In Phase II, the same pathologists will re-diagnose the same cases (after a wash-out period), although they will not know they are the same cases. For some cases in Phase II, pathologists will be provided with a different pathologist's diagnosis from Phase I. Using data from both Phases, Aim 2 will then quantify bias associated with providing a consulting pathologist with a prior diagnosis. The digital medium also offers novel opportunities to study the causes of pathologists' errors. Aim 3 will evaluate 60 additional pathologists' visual search behaviors when diagnosing digitized slides via novel eye-tracking technology. Our work will culminate in evaluating strategies based on the results of Aims 1-3 to reduce diagnostic errors by quantifying the potential impact of obtaining second opinions (Aim 4). No substantial attempts have been made to understand errors in the diagnosis of melanoma or to evaluate possible solutions. Our studies will identify underlying causes of diagnostic errors and guide design of future education and quality improvement efforts. These data are requisite for designing and implementing strategies to reduce the burden of diagnostic errors on patients and health care systems, to safely integrate digitized slides into clinical workflow, and to improve pathology practice.