Risk-based Breast Cancer Screening and Surveillance in Community Practice

项目概要-总体 随着新技术的普及，包括数字化， 乳腺断层合成摄影、乳腺磁共振成像（MRI）和全乳超声、筛查和 在临床环境中，监测选择正在迅速扩大， 个性化的临床和政策决策。基于风险的无症状乳腺癌筛查 妇女和乳腺癌幸存者的监测提供了优化获益-损害权衡的潜力， 定制成像频率和模态的选择。目前的P01在以下方面取得了临床重要进展： 从基于年龄的筛查转向基于风险的筛查：1）改进乳腺癌风险预测模型; 2） 评估乳腺成像性能及其与乳腺癌风险的关系; 3）评估 乳腺癌风险水平和弱势人群的成像使用;以及4）比较长期 使用微观模拟模型的定制筛选策略的结果。此次更新旨在推动 一种基于风险的新范式，根据女性的累积成像风险定制成像策略 结果，包括早期浸润性癌症的检测，漏诊或晚期癌症（成像） 失败）和假警报（假阳性回忆或活检建议），而不是整体乳腺癌 风险将通过三个互补项目实现方案目标。项目1采用创新方法 制定风险模型，以确定哪些妇女亚群值得考虑进行更密集或更不密集的治疗， 由于筛查失败或误报的风险很高，项目2采取 一种多层次的方法来研究断层合成和多模态筛查结果， 女性、放射科医生和设施因素。项目3侧重于确定针对风险的监测战略 乳腺癌幸存者的关键成像结果。除了项目整合和管理 两个共享的服务核心将为项目提供支持。生物统计学和数据管理核心将 提供高质量数据收集、管理、分析和共享的集中协调。以识别 不可接受的筛查和监测结果的临床可操作风险范围，并评估 为了解决定制筛选的长期影响，比较有效性核心将汇集专业人员， 在决策科学，风险沟通，调查研究和三个建立多学科的专业知识， 来自癌症干预和监测建模网络的模拟建模组。程序 利用乳腺癌监测联盟，一个建立和凝聚力的研究网络， 对来自260多万名妇女的高质量、基于社区的前瞻性个人数据收集 在地理和社会人口统计学上不同的地区，有超过90，000名乳腺癌幸存者。结果 该计划将为妇女、供应商和决策者提供相关和及时的信息， 最有效的乳腺癌筛查和监测策略的建议。

PROJECT SUMMARY – Overall As breast imaging undergoes rapid transformation with the diffusion of new technologies, including digital breast tomosynthesis, breast magnetic resonance imaging (MRI), and whole breast ultrasound, screening and surveillance options are rapidly expanding in clinical settings without adequate evidence to guide informed, individualized clinical and policy decision-making. Risk-based breast cancer screening of asymptomatic women and surveillance of breast cancer survivors offers the potential to optimize benefit–harm tradeoffs by tailoring imaging frequency and choice of modality. The current P01 has made clinically important advances in moving from age-based to risk-based screening by: 1) improving breast cancer risk prediction models; 2) evaluating breast imaging performance and their relation to breast cancer risk; 3) assessing the alignment of imaging use with breast cancer risk levels and for vulnerable populations; and 4) comparing long-term outcomes of tailored screening strategies using microsimulation models. This renewal proposes to advance a new risk-based paradigm that tailors imaging strategies based on women's cumulative risk of imaging outcomes, including detection of early stage invasive cancer, missed or advanced stage cancer (imaging failure), and false alarms (false-positive recall or biopsy recommendation), rather than on overall breast cancer risk. Program goals will be met through three complementary projects. Project 1 takes an innovative approach by developing risk models to identify subgroups of women who warrant consideration of more- or less-intensive strategies than guideline-based screening due to high risk of screening failures or false alarms. Project 2 takes a multi-level approach to studying tomosynthesis and multi-modality screening outcomes by examining women, radiologists, and facility factors. Project 3 focuses on identifying surveillance strategies tailored to risk of key imaging outcomes in breast cancer survivors. In addition to the Project Integration and Management team, two shared service cores will support the projects. The Biostatistics and Data Management Core will provide centralized coordination of high-quality data collection, management, analysis, and sharing. To identify clinically actionable ranges of risk for unacceptable screening and surveillance outcomes, and to evaluate the long-term implications of tailored screening, the Comparative Effectiveness Core will bring together specialized multidisciplinary expertise in decision sciences, risk communication, survey research, and three established simulation modeling groups from the Cancer Intervention and Surveillance Modeling Network. The program leverages the Breast Cancer Surveillance Consortium, an established and cohesive research network with high-quality, community-based, prospective individual-level data collection on >2.6 million women from geographically and socio-demographically diverse regions, with >90,000 breast cancer survivors. Results from this program will provide relevant and timely information for women, providers, and policymakers to develop recommendations for the most effective breast cancer screening and surveillance strategies.