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

项目摘要/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2700万年龄在40岁至74岁之间的女性乳房丰满，她们 晚期乳腺癌诊断率升高与预后不良相关。三十岁- 七个州现在要求乳房X光检查设施通知乳房致密的女性 乳房X光检查，并建议与他们的医疗保健提供者和国家 法律正在等待通过。在缺乏针对丰胸女性的筛查指南的情况下，一直有一种 补充超声筛查的使用急剧增加，这种筛查方法普遍可用，直接性低 医疗费用。早期对补充超声性能的研究表明，增加了癌症的检测，但 假阳性检查的高比率导致了不必要的活检。美国的预防服务 特别工作组呼吁进行研究，评估补充超声筛查对有意义的 临床结果，如晚期癌症发生率，为密闭症女性筛查指南提供参考 乳房。我们最近证明，乳房X光检查的失败率(即晚期癌症和 正常乳房X光检查后的间歇性癌症)乳房致密的女性之间的差异很大，根据 临床危险因素。因此，我们建议在一年内评估补充超声筛查的性能 新的基于风险的框架。我们假设补充超声筛查针对的是 乳房致密、乳房X光检查失败风险高的女性将产生有利的好处- 伤害简介。我们将使用100,000多次超声波筛查和200万次超声波检查的观测数据 通过乳腺癌监测联盟收集的乳房X光检查筛查检查(AIM 1) 根据技术(手持与自动)进行补充超声筛查的测试性能 和初步筛查的类型(数字乳房X光照相与数字乳房断层合成)；以及(目标2)评估 乳腺X光摄影筛查失败风险水平的补充筛查超声结果。这些 结果将被用作来自癌症干预和监视建模的两个模拟模型的输入 评估补充超声策略的长期益处、危害和成本的网络(目标3) 针对乳房X光检查失败风险较高的女性。我们的研究将是对 补充超声，并首次根据风险评估间歇性癌症和晚期癌症的比率 乳房X光检查失败。我们的结果将为女性提供急需的、可操作的证据， 医疗保健提供者和指南制定者评估乳房致密女性的筛查选择。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光检查不够充分的女性，同时将潜在的危害降至最低。

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.