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.

项目概要 设计/统计核心（DSC）将成为国家老龄化研究所（NIA）不可或缺的组成部分 阿尔茨海默病 (AD)/AD 相关痴呆 (AD/ADRD) 医疗保健系统 (HCS) 合作实验室。 与其他协作工作组核心和团队合作，开发知识并提供指导 进行严格的嵌入式实用临床试验 (ePCT)，以改善患者的护理和健康结果 痴呆症患者（PWD）及其照顾者（CG）将作为国家资源提供。 生物统计学专业知识到合作支持的试点研究、职业发展获奖者（CDA）以及 DSC 将为设计的各个方面做出贡献， 进行和分析这些项目，并将开发新的统计方法来设计和 对 HCS 内的 PWD 进行的 ePCT 分析，以推进这一领域并创造持久的知识。 存储库中，设计/统计核心将提供以下领域的指导：1) ePCT 的稳健设计，2) ePCT 的统计分析，3) 处理缺失数据、污染和其他违规行为的方法，4) 处理与 AD/ADRD 特定相关的陷阱的策略，5) 可复制性和再现性，6) 多重性和多重比较，7) 考虑代表性不足的少数群体和重要群体 亚组，包括将性别视为生物变量，8) 软件的记录和传播 和分析代码，9）出版和传播，10）初级定量的培训和指导 设计/统计核心的另一个主要功能是提供信息。 为整个 AD/ADRD 合作实验室，特别是试点研究提供咨询和服务， DSC 的工作将由 DSC 资助。 希瑟·阿洛尔 (Heather Allore) 博士、耶鲁大学医学院医学教授、 耶鲁大学公共卫生学院生物统计学家、耶鲁大学阿尔茨海默病研究主任 中心的数据管理和统计核心她是一位经验丰富的试用者和该领域的创始人。 阿洛尔博士将由六名杰出执行委员会成员组成的团队加入。 成员在 AD/ARDR 研究、衰老研究、整群随机试验和 在老年人中开展 ePCT DSC 的目标是： 目标 1：提供生物统计援助和 为合作试点研究、CDAs 接受者和 NIA 资助的研究人员规划或实施提供指导 PWD 和 CG 中的 ePCT；目标 2：开发新的生物统计方法，并创建和传播 与 HCS 残疾人士的 ePCT 设计和实施相关的指导文件和产品，目标 3： 与技术/数据核心合作，建立和管理管理数据的访问和共享（例如， 电子健康记录、索赔数据）供 AD/ADRD 合作研究人员使用（例如试点项目） 领导者），为可重复分析和重复研究提供指导。