Biostatistics and Data Management Core

项目摘要-生物统计和数据管理核心 生物统计和数据管理(BDM)核心将通过提供高质量数据收集、管理、分析和共享的集中协调，支持所有项目和比较有效性(CE)核心。BDM核心包括六个现有的(其中五个将收集新数据)和两个新的乳腺癌监测联盟(BCSC)乳房成像登记处和一个中央统计协调中心(SCC)。核心将通过向项目提供从共同的妇女群体中收集的数据并分享由单一分析支助小组执行的新的统计方法来提高效率。具体目标是：(1)收集、汇集、管理和共享满足项目目标所需的高质量数据；(2)通过将BCSC数据与妇女和机构层面的健康和人工智能算法分数决定因素的测量相联系，扩大BCSC数据资源；以及(3)与项目调查人员合作，实施合理和高效的研究设计，并执行有效的统计分析，以满足每个项目目标。BDM核心将利用从235个现有和44个新的BCSC乳房成像设施收集的290万名女性(包括8.1万名乳腺癌幸存者)的现有和新数据来实现这些目标。BCSC登记处与参与的乳房成像设施建立了牢固的关系，并建立了安全的数据收集和联系程序。数据将由SCC汇集和分析，SCC在数据管理、分析复杂的纵向观测数据、风险预测建模以及根据需要开发新的统计方法方面拥有丰富的经验，以克服现有方法的局限性。遵循BCSC完善的合作研究政策和程序，BDM核心将继续在与更广泛的研究社区共享数据方面取得成功。利用BCSC可用的一套独特的资源-我们建立的有凝聚力的研究网络；关于妇女、放射科医生和设施的纵向、个人水平数据的综合监测系统；访问具有良好特征的研究人群的基础设施；以及社区环境中统计方法和结果测量的专业知识-BCSC注册中心和SCC将继续合作，支持该计划项目，回答以其他方式无法解决的关键问题。这些优势结合在一起，使该计划的研究团队能够在社区实践中确定最有效的乳腺癌筛查和监测策略。

PROJECT SUMMARY – Biostatistics and Data Management Core The Biostatistics and Data Management (BDM) Core will support all Projects and the Comparative Effectiveness (CE) Core by providing centralized coordination of high-quality data collection, management, analysis, and sharing. The BDM Core includes six current (5 of which will collect new data) and two new Breast Cancer Surveillance Consortium (BCSC) breast imaging registries and a central Statistical Coordinating Center (SCC). The Core will increase efficiency by providing Projects with data collected from a common cohort of women and sharing novel statistical methods performed by a single analytical support team. The specific aims are to: (1) collect, pool, manage, and share high-quality data required to meet Project aims; (2) expand the BCSC data resource by linking BCSC data to woman- and facility-level measures of social determinants of health and artificial intelligence algorithm scores; and (3) collaborate with Program investigators to implement sound and efficient study designs and perform valid statistical analyses that address each Project aim. The BDM Core will accomplish these aims using existing and new data collected on 2.9 million women (including 81,000 breast cancer survivors with surveillance imaging) from 235 current and 44 new BCSC breast imaging facilities. The BCSC registries have built strong relationships with the participating breast imaging facilities and have established secure procedures for data collection and linkage. Data will be pooled and analyzed by the SCC, which has extensive experience in data management, analyzing complex longitudinal observational data, risk prediction modeling, and developing novel statistical methods as needed to overcome the limitations of existing methods. Following the BCSC’s well-established collaborative research policies and procedures, the BDM Core will continue its successes in sharing data with the broader research community. Using the unique set of resources available to the BCSC—our established and cohesive research network; integrated surveillance system of longitudinal, individual-level data on women, radiologists, and facilities; infrastructure for accessing well-characterized study populations; and expertise in statistical methods and outcomes measurement in community settings—the BCSC registries and SCC will continue working together to support this Program project in answering key questions that cannot be addressed otherwise. These combined strengths ideally position the Program’s research teams to determine the most effective breast cancer screening and surveillance strategies in community practice.