Estimating the impact of mammography screening disruptions during the COVID-19 pandemic

估计 COVID-19 大流行期间乳房 X 光检查筛查中断的影响

基本信息

批准号：
10171213
负责人：
Brian L Sprague
金额：
$ 18万
依托单位：
UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-01 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10171213
关键词：
Address Advanced Malignant Neoplasm Advisory Committees Age Biopsy Breast Breast Cancer Detection Breast Cancer Risk Factor Breast Cancer Surveillance Consortium COVID-19 COVID-19 pandemic Cancer Control Cancer Detection Cancer Intervention and Surveillance Modeling Network Characteristics Chicago Clinical Containment Data Data Analyses Decision Making Detection Diagnostic Diagnostic Imaging Digital Breast Tomosynthesis Digital Mammography Effectiveness Epidemiologist Evaluation Expert Opinion Failure Funding Future Geography Guidelines Health Insurance Health Personnel Health Services High Risk Woman Home environment Incidence Infrastructure Interruption Intervention Laws Malignant Neoplasms Mammary Gland Parenchyma Mammographic screening Mammography Medical Medical Care Costs Modeling Outcome Pattern Performance Phase Positioning Attribute Preventive service Provider Public Health Recording of previous events Registries Regulation Research Personnel Risk Risk Factors San Francisco Services Social Distance Source Stage at Diagnosis System Techniques Time Ultrasonography United States Universities Variant Vermont Wisconsin Woman advanced breast cancer aged base breast cancer diagnosis breast cancer registry breast density breast imaging care providers clinical practice clinical risk computerized data processing cost experience high risk imaging detection imaging facilities improved interdisciplinary collaboration malignant breast neoplasm mammography registry models and simulation mortality neoplasm registry network models pandemic disease performance tests population based racial diversity radiologist screening screening guidelines supplemental screening tool trend willingness

项目摘要

PROJECT SUMMARY/ABSTRACT Breast density is a risk factor for developing breast cancer and decreases the accuracy of screening mammography. An estimated 27 million women aged 40-74 in the U.S. have dense breasts and they experience elevated rates of advanced stage breast cancer diagnoses associated with poor outcomes. Thirty- seven states now require mammography facilities to notify women with dense breasts of the limitations of mammography and recommend discussion of screening options with their healthcare providers, and a national law is pending. In the absence of screening guidelines for women with dense breasts, there has been a dramatic increase in use of supplemental ultrasound screening, which is widely available and has low direct medical costs. Early studies of supplemental ultrasound performance suggest increased cancer detection but high rates of false positive exams leading to unnecessary biopsies. The United States Preventive Services Task Force has called for studies that evaluate the impact of supplemental ultrasound screening on meaningful clinical outcomes, such as advanced cancer rates, to inform screening guidelines for women with dense breasts. We recently demonstrated that mammography screening failure rates (i.e., advanced cancers and interval cancers after a normal mammogram) among women with dense breasts vary widely according to clinical risk factors. Therefore, we propose to assess supplemental ultrasound screening performance within a new risk-based framework. We hypothesize that supplemental ultrasound screening targeted to the subset of women with dense breasts at high risk of mammography screening failures will yield a favorable benefit-to- harm profile. We will use observational data from more than 100,000 screening ultrasound exams and 2 million mammography screening exams collected via the Breast Cancer Surveillance Consortium to (Aim 1) examine the test performance of supplemental screening ultrasound according to technique (handheld vs. automated) and type of primary screening (digital mammography vs. digital breast tomosynthesis); and (Aim 2) evaluate supplemental screening ultrasound outcomes across levels of risk for mammography screening failures. These results will be used as inputs in two simulation models from the Cancer Intervention and Surveillance Modeling Network to (Aim 3) evaluate the long-term benefits, harms, and costs of supplemental ultrasound strategies targeted to women at high risk of mammography screening failures. Our study will be the largest evaluation of supplemental ultrasound and the first to evaluate rates of interval and advanced cancers according to risk of mammography screening failures. Our results will provide urgently needed, actionable evidence for women, healthcare providers, and guideline-makers evaluating screening options for women with dense breasts. This evidence will support effective supplemental screening strategies that reduce the burden of breast cancer among women for whom mammography screening is not adequate, while minimizing potential harms.

项目概要/摘要乳房密度是患乳腺癌的危险因素，会降低筛查的准确性乳房X光检查。据估计，美国有 2700 万 40-74 岁的女性拥有致密的乳房，她们晚期乳腺癌诊断率升高且预后不良。三十- 现在有七个州要求乳房 X 光检查设施，以告知乳房致密的妇女进行乳房 X 光检查的局限性乳房 X 光检查，并建议与医疗保健提供者和全国性机构讨论筛查方案法律正在等待中。在缺乏针对致密乳房女性的筛查指南的情况下，补充超声筛查的使用急剧增加，该筛查广泛应用且直接性低医疗费用。补充超声性能的早期研究表明，癌症检出率有所提高，但高假阳性率导致不必要的活检。美国预防服务部门工作组呼吁开展研究，评估补充超声筛查对有意义的影响临床结果，例如晚期癌症发生率，为患有密集型癌症的女性提供筛查指南乳房。我们最近证明，乳房 X 光检查筛查失败率（即晚期癌症和乳房致密的女性中，正常乳房 X 光检查后的间隔期癌症差异很大，具体取决于临床危险因素。因此，我们建议在一段时间内评估补充超声筛查的表现新的基于风险的框架。我们假设补充超声筛查针对以下子集：乳房致密的女性，乳房 X 光检查筛查失败的风险很高，这将带来有利的好处：危害概况。我们将使用来自超过 100,000 次筛查超声检查和 200 万次超声检查的观察数据通过乳腺癌监测联盟收集的乳房 X 光检查筛查检查（目标 1）根据技术（手持式与自动式）补充筛查超声的测试性能和初级筛查的类型（数字乳房 X 线摄影与数字乳房断层合成）；和（目标 2）评估补充筛查超声结果跨越乳房X光检查筛查失败的风险水平。这些结果将用作癌症干预和监测建模的两个模拟模型的输入建立网络（目标 3）评估补充超声策略的长期效益、危害和成本针对乳房X光检查筛查失败的高风险女性。我们的研究将是最大规模的评估补充超声检查，并且第一个根据癌症风险评估间期癌症和晚期癌症的发生率乳房X光检查筛查失败。我们的结果将为女性提供迫切需要的、可操作的证据，医疗保健提供者和指南制定者正在评估针对致密乳房女性的筛查选择。这证据将支持有效的补充筛查策略，以减轻乳腺癌的负担对于乳房X光检查筛查不充分的女性，同时最大限度地减少潜在危害。