Risk-based Breast Cancer Screening and Surveillance in Community Practice

项目总结--总体 随着包括数字技术在内的新技术的普及，乳房成像经历了快速的变革 乳房断层合成、乳房磁共振成像(MRI)和全乳房超声、筛查和 在没有足够证据指导知情的情况下，临床环境中的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 妇女和对乳腺癌幸存者的监测提供了通过以下方式优化利弊权衡的潜力 定制成像频率和模式选择。目前的P01在临床上取得了重要的进展 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) 评估乳房影像表现及其与乳腺癌风险的关系；3)评估 与乳腺癌风险水平和脆弱人群的成像使用；以及4)长期比较 使用微观模拟模型的量身定制的筛选策略的结果。此次续签提议提前一年 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，包括发现早期浸润性癌症、漏诊或晚期癌症(成像 失败)和错误警报(假阳性回忆或活组织检查建议)，而不是针对整个乳腺癌 风险。计划目标将通过三个互补的项目来实现。项目1采用创新的方法 通过开发风险模型来确定需要考虑高强度或低强度治疗的妇女亚群 由于筛查失败或错误警报的风险很高，因此基于指南的筛查比基于指南的筛查更有效。项目2需要 通过检查研究断层合成和多模式筛查结果的多层次方法 女性、放射科医生和设施因素。项目3侧重于确定针对风险量身定做的监测战略 乳腺癌幸存者的关键影像结果。除了项目集成和管理 两个共享服务核心将为这些项目提供支持。生物统计和数据管理核心将 提供高质量数据收集、管理、分析和共享的集中协调。要确定 临床可操作的不可接受的筛查和监测结果的风险范围，并评估 量身定制筛查的长期影响，比较有效性核心将汇集专门的 决策科学、风险沟通、调查研究方面的多学科专业知识，以及三个已建立的 来自癌症干预和监测建模网络的模拟建模小组。该计划 利用乳腺癌监测联盟，这是一个成熟的、有凝聚力的研究网络， 收集来自&gt；260万女性的高质量、基于社区的预期个人级别数据 地理和社会人口结构不同的地区，有90,000名乳腺癌幸存者。结果来自 该计划将为妇女、提供者和政策制定者提供相关和及时的信息，以供制定 建议最有效的乳腺癌筛查和监测策略。

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.