Reducing Errors in the Diagnosis of Melanoma and Melanocytic Lesions

减少黑色素瘤和黑色素细胞病变的诊断错误

• 批准号: 9005424
• 负责人: JOANN G ELMORE
• 金额: $ 67.64万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9005424
• 关键词: Adopted; Adult; Appetitive Behavior; Area; Attention; Behavior; Benchmarking; Biopsy; Biopsy Specimen; Blinded; Board Certification; Clinical; Cognitive; Complex; Computers; Consensus; Consult; Data; Decision Making; Diagnosis; Diagnostic; Diagnostic Errors; Dysplastic Nevus; Education; Elderly; Emerging Technologies; Ensure; Eye; Eye Movements; Foundations; Future; Glass; Gold; Health Services Research; Healthcare Systems; Histopathology; Incidence; Internet; Knowledge; Lead; Learning; Lesion; Malignant Neoplasms; Medical; Medical Device; Medical Errors; Methods; Movement; Participant; Pathologist; Pathology; Patients; Pattern; Performance; Phase; Physicians; Precancerous melanosis; Procedures; Process; Public Health; Randomized; Recommendation; Recruitment Activity; Research; Sampling; Second Opinions; Skin; Slide; Source; Staging; Structure; Techniques; Technology; Testing; Time; Validation; Variant; Visual; Work; accurate diagnosis; base; clinical care; design; diagnosis standard; diagnostic accuracy; digital media; improved; innovation; interest; light microscopy; melanoma; novel; public health relevance; screening; simulation; tool; visual search

 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.

 描述（由申请人提供）：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色素细胞病变的准确性。黑色素瘤的发病率上升速度比任何其他癌症都快，2015年，每50名美国成年人中就有1人被诊断患有黑色素瘤。黑色素瘤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，必须作为诊断的一部分进行评估;其他类型的活检仅需要细胞水平的评估。我们以前的工作揭示了黑色素瘤诊断中大量和频繁的错误：病理学家在高达60%的原位黑色素瘤和早期浸润性黑色素瘤病例中意见不一。误诊可能导致严重的患者伤害。这些错误对公共卫生的影响可能会越来越大，因为皮肤活检的数量越来越多，估计每10个美国老年人中就有1个目前每年接受皮肤活检手术。 数字化载玻片（通过将皮肤活检的载玻片数字化而创建）的新兴技术正在扩展到病理学教育和委员会认证测试。由于数字化载玻片能够从任何计算机进行远程诊断，因此越来越多的人对采用数字化载玻片进行初步诊断和/或第二意见感兴趣。FDA目前将数字化载玻片视为III类医疗器械，在批准广泛临床使用之前需要额外的数据。 我们将比较240名美国病理学家在我们工作的第一阶段（目标1）中对黑素细胞病变的数字化与玻璃载玻片诊断的准确性。数字化载玻片的验证对于确保基于数字化载玻片的诊断性能至少等同于玻璃载玻片和光学显微镜的诊断性能至关重要。在第二阶段，相同的病理学家将重新诊断相同的病例（经过一段洗脱期），尽管他们不知道它们是相同的病例。对于II期的某些病例，将向病理学家提供与I期不同的病理学家诊断。使用来自两个阶段的数据，目标2将量化与向咨询病理学家提供既往诊断相关的偏倚。数字媒体也为研究病理学家的错误原因提供了新的机会。目标3将评估另外60名病理学家在通过新型眼动追踪技术诊断数字化切片时的视觉搜索行为。我们的工作将最终在评估战略的基础上的结果，目标1-3，以减少诊断错误，通过量化的潜在影响，获得第二意见（目标4）。 没有实质性的尝试，以了解错误的诊断黑色素瘤或评估可能的解决方案。我们的研究将确定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少患者和医疗保健系统的诊断错误负担，安全地将数字化载玻片整合到 临床工作流程，并改善病理学实践。