Extending the Diversity, Reach, and Generalizability of the WISDOM Study

扩展 WISDOM 研究的多样性、范围和普遍性

• 批准号: 9888251
• 负责人: LAURA J ESSERMAN
• 金额: $ 150.84万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 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/9888251
• 关键词: Adopted; Adoption; Advocate; Age; Alabama; Blue Cross; Blue Shield; Boston; Breast; Breast Cancer Detection; Breast Cancer Risk Factor; Breast Cancer Treatment; California; Cancer Biology; Caring; Chicago; Clinical; Clinical Services; Collaborations; Conflict (Psychology); Confusion; Contracts; Country; Data; Disease; Employee; Enrollment; Ensure; Ethnic Origin; Exhibits; Family; Feedback; Florida; Frequencies; Funding; Genes; Genetic Predisposition to Disease; Geography; Goals; Gold; Guidelines; Health; Healthcare; Home environment; Illinois; Individual; Infrastructure; Inherited; Insurance Carriers; Insurance Coverage; Intention; International; Internist; Investments; Knowledge; Learning; Louisiana; Malignant Neoplasms; Mammography; Measures; Midwestern United States; Minnesota; Modality; Modeling; Modernization; Mutation; New Jersey; Oregon; Outcome; Paralysed; Participant; Patient-Focused Outcomes; Population; Population Heterogeneity; Predisposition; Preventive Intervention; Randomized; Recommendation; Recording of previous events; Research Institute; Risk; Risk Assessment; Risk Factors; Safety; Science; Secure; Single Nucleotide Polymorphism; Site; Societies; South Carolina; Target Populations; Technology; Testing; Time; Traction; Translating; United States; United States Department of Veterans Affairs; Universities; Update; Utah; Variant; Veterans; Washington; Woman; arm; base; breast density; clinical research site; comorbidity; cost; demographics; design; experience; geographic population; high risk; improved; individualized medicine; innovation; knowledge translation; learning progression; malignant breast neoplasm; outreach; patient oriented; personalized approach; personalized screening; polygenic risk score; population based; pragmatic trial; precision medicine; preference; programs; psychologic; recruit; routine screening; screening; screening guidelines; socioeconomics; study population; testing services; trial comparing; trial design; uptake

PROJECT SUMMARY/ABSTRACT The WISDOM Study (Women Informed to Screen Depending on Measures of risk) is a pragmatic trial comparing a personalized approach to breast cancer screening – in which the intensity and modality of screening is dependent upon stratified personal risk -- against the gold standard of annual screening. The goal is to determine whether a personalized approach is as safe, less morbid, better accepted by women, encourages uptake of preventive interventions, and is of higher health care value (better outcomes at less cost psychologically, physically, and financially). In this proposal `Expanding the WISDOM Study's Diversity, Reach, and Generalizability', we are seeking support to expand the study to additional sites around the country to enhance recruitment, improve study power and increase both the geographic and population diversity of study participants. By doing so, our intention is to increase the generalizability of the study results. Using a unique coverage with evidence progression model, we have secured insurance coverage and outreach collaboration from multiple payers, giving us the opportunity to enroll from an additional population of ~6 million women across multiple regions and varied ethnic and socioeconomic backgrounds. The network of sites that this proposal will enable us to add will allow us to create a collaborative group to continuously improve screening and learn who is at risk for what kind of cancer. The personalized screening arm includes a risk assessment based on family history, exposures, breast density, co-morbidity and genetic predisposition (presence of mutations in the 9 genes associated with screening and the combination of the small variation in inherited genes, the single nucleotide polymorphisms, into a polygenic risk score or PRS). Importantly, the PRS score is tailored to different ethnicities based on advances in the science of risk assessment, allowing us to translate these important findings into practice. We are using an adaptive approach in which the risk model is updated over the course of the trial as new information emerges. The personalized approach yields an integrated risk score that allows us to assign an age to start, an age to stop, a frequency of screening, and a modality for screening. The R01 Specific Aims are to: 1. Open new clinical sites with experience enrolling targeted populations and use culturally targeted materials to increase the numbers in and diversity of the WISDOM study population 2. Enhance trial enrollment and retention through national partnerships, centralized campaigns across the network and embedded analytics with real time feedback

项目摘要/摘要 智慧研究(妇女被告知根据风险指标进行筛查)是一项 比较乳腺癌筛查的个性化方法的务实试验--在该试验中 筛查的强度和方式取决于分层的个人风险--相对于黄金 年度筛查标准。目标是确定个性化方法是否与 安全、不那么病态、更好地被妇女接受，鼓励采取预防性干预措施， 并且具有更高的医疗保健价值(以更少的心理、身体和 财务方面)。 在这项“扩大智慧研究的多样性、覆盖面和概括性”的建议中，我们 寻求支持，以将研究扩展到全国各地的更多地点，以增强 招聘，提高学习能力，增加地理和人口多样性 研究参与者。通过这样做，我们的目的是增加研究的概括性 结果。使用独特的承保范围和证据递增模式，我们获得了保险 来自多个付款人的覆盖和外展协作，使我们有机会登记 从多个地区、不同种族和地区新增的约600万妇女 社会经济背景。这项提案将使我们能够添加的站点网络将 允许我们创建协作小组，以不断改进筛选并了解谁在 哪种癌症的风险。 个性化筛查分支包括基于家族史、暴露、 乳房密度、合并症和遗传易感性(9个基因存在突变 与筛选和结合遗传基因的小变异有关， 单核苷酸多态，转化为多基因风险分数(PR)。重要的是，减贫战略 评分是根据风险评估科学的进步为不同种族量身定做的， 使我们能够将这些重要的发现转化为实践。我们使用的是自适应的 在试验过程中将风险模型更新为新信息的方法 出现了。个性化方法产生一个集成的风险分值，使我们能够为 开始的年龄、停止的年龄、筛查的频率和筛查的方式。 R01的具体目标是： 1.开设新的临床网站，有招募目标人群和文化用途的经验 有针对性地增加智慧研究的数量和多样性 人口 2.通过国家伙伴关系、集中宣传活动加强试行登记和保留 跨网络和嵌入式分析，并提供实时反馈