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（由申请人证明）：提高诊断黑色素细胞病变的病理学家的支撑研究将比任何Eather Cancer诊断出比任何Eather Cancer的增长速度更快。在组织病理学的一部分中，最挑战性的皮肤活检需要在诊断黑色素的诊断中遇到的一部分。鉴于估计有10个年龄较大的成年人的皮肤活检的数量增加，目前正在接受皮肤活检的载体幻灯片计算机，对采用数字化载玻片进行初级诊断和/或第二个合同D幻灯片的兴趣日益增加，在我们工作中，在阶段批准了广泛的临床病理学与黑素细胞病变的广泛临床病理学家之前需要更多数据（AIM 1）。具有不同病理学家的病理学家与第1阶段的诊断。使用两个阶段的数据，AIM 2将与先前诊断的病理学家相关当通过新颖的眼睛跟踪技术降低目标1-3的结果时，通过量化了诊断错误，通过量化诊断错误的可能性（AIM 4）。诊断和指导未来教育和质量改进工作的原因。临床工作流程，并改善病理实践。