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Core 3: Assessment and Analysis Shared Resource Core

Core 3: Assessment and Analysis Shared Resource Core
核心3:评估与分析共享资源核心
批准号:
10247790
负责人:
MARIA PISU
金额:
$58.69万
依托单位国家:
美国
项目类别:
财政年份:
2018
资助国家:
美国
项目状态:
已结题
起止时间:
2018-09-01 至 2024-08-31

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项目成果

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中文摘要
翻译
Amplifi评估和分析(AA)共享资源核心(SRC)的主要目标是 通过收集数据和生物样品,支持所有Amplifi项目和SRC的科学目标, 数据管理、统计和成本效益分析。机管局SRC将与 并协助招募和保留(RR)和适应、传播和实施(ADI)和 管理(管理)SRC,并利用阿拉巴马大学的特殊资源 伯明翰。AA SRC的具体目标是:(1)实施Amplifi研究设计。机管局SRC 将使用区组随机化将652名幸存者随机分配到Amplifi研究组;(2)促进放大 数据的收集、录入和管理。AA SRC将输入或下载、管理、清理和链接所有 从癌症登记获得的Amplifi数据、筛查和招募过程、参与者评估、 和实验室。将建立一个红帽系统,跟踪数据收集材料的发送和接收情况。 参与者的评估将包括自我管理的问卷、电话调查、家访( 包括血液和尿液样本采集)和加速度计监测。家访将由以下人员进行 检查管理服务公司(EMSI),一家拥有训练有素的护士的公司,在以前的研究中使用 学习。AA SRC将处理、准备统计分析,并存储来自Amplifi项目和 ADI和RR SRC;(3)规划和进行Amplifi项目和核心的统计分析。机管局 SRC通过以下方式为项目调查人员和SRC领导提供专业的统计和方法咨询 规划和进行统计分析,以支持Amplifi项目,并对RR进行额外分析 和ADI SRC。这将包括测试Amplifi干预措施对主要结果的有效性, 探讨干预措施对次级结果的影响(包括生活质量、身体功能和 表现、身体成分以及炎症、免疫功能和成功衰老的生物标志物), 进行调解人/调解人分析,以确定干预措施发挥作用的结构 以及影响干预效果的主要幸存者特征;以及(4)规划和实施成本- 扩增干预措施的有效性分析。AA SRC将评估测试的干预措施是否 经济上有吸引力,即评估干预措施在生活质量提高方面的益处与 净费用(实施费用--节省的医疗费用,如果有的话)。实现这些目标将 通过展示其有效性和成本,有助于更广泛地传播经测试的干预措施-- 有效性,它们影响生活方式行为的机制,以及它们在谁身上效果最好。 优秀的AA SRC团队在实施研究设计、执行数据方面拥有数十年的经验 收集和管理,并进行统计和成本效益分析。因此,这是很好的 定位于为Amplifi目标和癌症生存研究的进步做出贡献。
英文摘要
The primary objective of the AMPLIFI Assessment and Analysis (AA) Shared Resource Core (SRC) is to support the scientific objectives of all AMPLIFI projects and SRCs through data and biospecimen collection, data management, and statistical and cost-effectiveness analysis. The AA SRC will work in collaboration with and assist the Recruitment and Retention (RR) and Adaptation, Dissemination, and Implementation (ADI) and the Administration (ADMIN) SRCs, and leverage exceptional resources at the University of Alabama at Birmingham. The AA SRC's specific aims are: (1) To implement the AMPLIFI study design. The AA SRC will randomize 652 survivors to the AMPLIFI study arms using block randomization; (2) To facilitate AMPLIFI data collection, entry and management. The AA SRC will enter or download, manage, clean, and link all AMPLIFI data obtained from cancer registries, screening and recruitment process, participants' assessments, and laboratories. A REDCap system will be set up to track data collection materials sent and received. Participants' assessments will consist of self-administered questionnaires, phone surveys, home visits (which include blood and urine sample collection) and accelerometer monitoring. Home visits will be conducted by Examination Management Services Inc. (EMSI), a company with trained nurses used in previous research studies. The AA SRC will process, prepare for statistical analysis, and store data from AMPLIFI projects and ADI and RR SRCs; (3) To plan and conduct statistical analyses for AMPLIFI Projects and Cores. The AA SRC provides expert statistical and methodological consultation to project investigators and SRC leaders by planning and conducting statistical analyses in support of AMPLIFI projects, and additional analyses for the RR and ADI SRCs. This will include testing the efficacy of the AMPLIFI interventions on the primary outcomes, exploring the interventions' impact on secondary outcomes (including quality of life, physical functioning and performance, body composition, and biomarkers of inflammation, immune function, and successful aging), conducting mediator/moderator analyses to ascertain the constructs by which the intervention exerts its effects and the key survivor characteristics that influence intervention efficacy; and (4) To plan and conduct cost- effectiveness analyses of the AMPLIFI interventions. The AA SRC will assess if the tested interventions are economically attractive, i.e., assess how interventions' benefits in terms of quality of life gains compare with their net cost (implementation costs – savings in health care costs, if any). Attainment of these aims will contribute to the wider dissemination of the tested interventions by demonstrating their efficacy and cost- effectiveness, the mechanisms by which they work to impact lifestyle behaviors, and in whom they work best. The outstanding AA SRC team has decades of experience in implementing study designs, performing data collection and management, and conducting statistical and cost-effectiveness analyses. Therefore, it is well positioned to contribute to AMPLIFI goals and to the advancement of cancer survivorship research.
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