Design-Statistical Core

设计统计核心

• 批准号: 10673667
• 负责人: Heather Gwynn Allore
• 金额: $ 76.07万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673667
• 关键词: Address; Aging; Alzheimer' s Disease; Alzheimer' s disease related dementia; Area; Biological; Biometry; Caregivers; Caring; Clinical; Clinical Investigator; Cluster randomized trial; Code; Collaborations; Committee Members; Complex; Computer software; Conduct Clinical Trials; Consultations; Data; Data Coordinating Center; Dementia; Development; Doctor of Philosophy; Documentation; Effectiveness; Elderly; Electronic Health Record; Elements; Ensure; Funding; Gerontology; Goals; Health; Healthcare Systems; Heterogeneity; Intervention; K-Series Research Career Programs; Knowledge; Leadership; Measurement; Medicine; Mentors; Methodology; Methods; National Institute on Aging; Outcome; Patients; Personal Satisfaction; Persons; Pilot Projects; Population; Pragmatic clinical trial; Privatization; Procedures; Public Health Schools; Publications; Randomized; Records; Reporting; Reproducibility; Research; Research Design; Research Personnel; Resources; Sample Size; Scientist; Services; Statistical Data Interpretation; Subgroup; Techniques; Testing; Textbooks; Time; Training; Underrepresented Minority; United States National Institutes of Health; Validity and Reliability; Vulnerable Populations; Work; career; career development; collaboratory; data registry; design; experience; health assessment; improved; innovation; insight; instrument; knowledge repository; medical schools; novel; prevent; professor; quality assurance; sex; software development; statistics; systems research; working group

PROJECT SUMMARY The Design/Statistics Core (DSC) will be an indispensable component of the National Institute of Aging (NIA) Alzheimer's disease (AD)/AD-related dementia (AD/ADRD) Healthcare Systems (HCS) Collaboratory. It will work with other Collaboratory Work Group Cores and Teams to develop knowledge and provide guidance to conduct rigorous embedded pragmatic clinical trials (ePCTs) to improve the care and health outcomes of persons with dementia (PWD) and their caregivers (CGs). It will serve as a national resource providing biostatistical expertise to Collaboratory-supported pilot studies, career development awardees (CDAs), and other NIA-funded investigators conducting such trials. The DSC will contribute to all aspects of the design, conduct, and analysis of these projects, and will develop novel statistical methodology for the design and analysis of ePCTs conducted among PWD within HCS. To advance this field and create a durable knowledge repository, the Design/Statistics Core will provide guidance in areas such as: 1) robust design of ePCTs, 2) statistical analysis of ePCTs, 3) methods for handling missing data, contamination, and other irregularities, 4) strategies for dealing with pitfalls of specific relevance to AD/ADRD, 5) replicability and reproducibility, 6) multiplicity and multiple comparisons, 7) consideration of under-represented minorities and important subgroups, including treatment of sex as a biological variable, 8) documentation and dissemination of software and analytic code, 9) publication and dissemination, and 10) training and mentoring of junior quantitative scientists and clinical investigators. The Design/Statistics Core’s other main function will be to provide consultation and services to the AD/ADRD Collaboratory as a whole and particularly to the pilot studies, career, CDA recipients, and other NIA-funded investigators. The work of the DSC will be enabled by the leadership of Dr. Heather Allore PhD, Professor of Medicine in the Yale School of Medicine, and Professor of Biostatistics at the Yale School of Public Health, and Director of the Yale Alzheimer's Disease Research Center's Data Management and Statistics Core. She is an experienced trialist and founder of the field of Gerontological Biostatistics. Dr. Allore will be joined by a team of six exceptional Executive Committee members who bring varied expertise in AD/ARDR research, aging research, cluster randomized trials, and the conduct of ePCTs in older persons. The DSC’s Aims are: Aim 1: To provide biostatistical assistance and guidance to Collaboratory pilot studies, CDAs recipients and NIA-funded investigators planning or conducting ePCTs in PWD and CG; Aim 2: To develop novel biostatistical approaches, and create and disseminate guidance documents and products relevant to the design and conduct of ePCTs in PWD with HCS, Aim 3: To work with the Technical/Data Core, to establish and manage access to and sharing of administrative data (e.g., electronic health records, claims data) for use by AD/ADRD Collaboratory investigators (e.g. pilot project leaders), in providing guidance on reproducible analyses and replication studies.

项目摘要 设计/统计核心（DSC）将是美国国家老化研究所（NIA）的必不可少的组成部分 阿尔茨海默氏病（AD）/与AD相关的痴呆症（AD/ADRD）医疗保健系统（HCS）协作。会 与其他协作工作组核心和团队合作，以发展知识并为 进行严格的嵌入式务实临床试验（EPCT），以改善 患有痴呆症（PWD）及其护理人员（CGS）的人。它将作为提供的国家资源 为合作支持的试点研究，职业发展获奖者（CDA）和 其他NIA资助的研究人员进行了此类试验。 DSC将有助于设计的各个方面 对这些项目进行和分析，并将开发设计新颖的统计方法论 对HCS中PWD进行的EPCT的分析。推进这一领域并创建耐用的知识 存储库，设计/统计核心将在以下领域提供指导：1）EPCT的强大设计，2） EPCT的统计分析，3）处理缺失数据，污染和其他违规性的方法，4） 处理与AD/ADRD具有特定相关性的陷阱的策略，5）复制性和可重复性，6） 多次比较，7）考虑代表不足的少数民族和重要 亚组，包括将性作为生物变量的处理，8）文档和软件传播 和分析法，9）出版和传播，以及10）初级定量的培训和心理 科学家和临床研究人员。设计/统计核心的其他主要功能将是提供 对整个广告/ADRD合作的咨询和服务，尤其是对试点研究， 职业，CDA接收者和其他NIA资助的调查人员。 DSC的工作将由 耶鲁医学院医学教授希瑟·阿洛雷（Heather Allore）博士的领导 耶鲁大学公共卫生学院的生物统计学，耶鲁阿尔茨海默氏病研究主任 中心的数据管理和统计核心。她是一位经验丰富的审判员，也是该领域的创始人 老年生物统计学。 Allore博士将由六个杰出执行委员会组成的团队加入 在AD/ARDR研究，衰老研究，聚类随机试验和 老年人的EPCT进行。 DSC的目的是：目标1：提供生物统计援助和 协作试点研究，CDA的收件人和NIA资助的调查人员计划或进行的指导 PWD和CG中的EPCT；目标2：开发新颖的生物统计方法，并创建和传播 与HCS在PWD中设计和行为相关的指南文档和产品，目标3： 与技术/数据核心合作，建立和管理对管理数据的访问和共享（例如， 电子健康记录，索赔数据）用于AD/ADRD合作调查人员的使用（例如，试点项目 领导者），在提供可再现分析和复制研究的指导时。