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

基本信息

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
项目类别：
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

项目摘要

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要快，大约五分之一的美国成年人将被诊断为黑色素瘤。 2015. 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结构，必须作为诊断的一部分进行评估；我们之前的工作揭示了黑色素瘤诊断中存在大量且频繁的错误：病理学家对高达 60% 的原位黑色素瘤和早期侵袭性黑色素瘤病例的误诊可能会造成重大影响。鉴于进行的皮肤活检数量不断增加，这些错误对公共健康的影响可能会越来越大——据估计，目前每年有十分之一的美国老年人接受皮肤活检手术。（通过数字化皮肤活检的玻璃载玻片创建）正在扩展到病理学教育和委员会认证测试，由于数字化载玻片可以从任何计算机进行远程诊断，因此 FDA 目前对采用数字化载玻片进行初步诊断和/或第二意见越来越感兴趣。认为数字化载玻片属于 III 类医疗设备，在批准广泛临床使用之前需要额外的数据。我们将比较 240 名美国病理学家对黑色素细胞数字化载玻片和玻璃载玻片的诊断准确性。在我们工作的第一阶段（目标 1）中，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与玻璃载玻片和光学显微镜的诊断性能相同至关重要。诊断相同的病例（经过清洗期后），尽管他们不知道它们是相同的病例。对于第二阶段的某些病例，病理学家将获得与第一阶段不同的病理学家的诊断。使用来自第一阶段的数据。在这两个阶段中，目标 2 将量化与向咨询病理学家提供先前诊断相关的偏差，数字媒体还提供了研究病理学家错误原因的新机会，目标 3 将评估另外 60 名病理学家在诊断数字化时的视觉搜索行为。我们的工作最终将根据目标 1-3 的结果评估策略，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). 尚未进行实质性尝试来了解黑色素瘤的诊断错误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的教育和质量改进工作。实施战略以减少诊断错误给患者和医疗保健系统带来的负担，将数字化切片安全地集成到临床工作流程，并改善病理实践。