Methodologic Core

方法论核心

• 批准号: 10708109
• 负责人: Jungwha Julia Lee
• 金额: $ 33.3万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-19 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10708109
• 关键词: Acceleration; Accelerometer; Address; Area; Attention; Behavioral; Behavioral Sciences; Bioinformatics; COVID-19 impact; Clinical; Clinical Informatics; Clinical Research; Collaborations; Communities; Consultations; Creativeness; Data; Data Analyses; Data Collection; Database Management Systems; Databases; Development; Development Plans; Disease; Educational Activities; Electronic Health Record; Elements; Environment; Epidemiology; Event; Faculty; Fostering; Foundations; Genomics; Grant; Individual; Informed Consent; Infrastructure; Institution; Intervention; Lead; Learning; Life; Life Style; Manuscripts; Medical; Medicine; Mental Health; Mentors; Methodology; Mission; Musculoskeletal; Musculoskeletal Diseases; National Institute of Arthritis, and Musculoskeletal, and Skin Diseases; Neighborhoods; Nutritional Science; Outcome; Outcome Measure; Patient Outcomes Assessments; Patient Self-Report; Patients; Performance; Physical Function; Physical activity; Physical assessment; Physiological; Policy Analysis; Prevention strategy; Productivity; Recommendation; Registries; Rehabilitation therapy; Reproducibility; Research; Research Activity; Research Design; Research Infrastructure; Research Personnel; Research Support; Resources; Rheumatism; Safety; Services; Sleep; Social outcome; Specialist; Statistical Data Interpretation; Training; Universities; Visit; Vulnerable Populations; Work; advanced analytics; clinical center; clinical implementation; cohort; community engagement; coronavirus disease; data management; data streams; data warehouse; design; economic evaluation; electronic data; experience; handheld mobile device; improved; innovation; next generation; pandemic disease; performance based measurement; person centered; personalized approach; physical conditioning; pragmatic study; preventive intervention; psychologic; public health research; recruit; repository; resilience; response; satisfaction; sedentary lifestyle; sensor; social health determinants; stakeholder perspectives; therapy development; translational scientist; virtual; wearable sensor technology; web based interface

The mission of the CCCR Methodologic Core is – in the COVID era – to accelerate clinical research in musculoskeletal and rheumatic diseases by providing state-of-art expertise to design and develop impactful studies and innovative interventions, and execute rigorous data collection, management, and analysis . While most COVID-19 impacts were negative, many responses have been positive, leading to creative solutions for informed consent, study visits, and use of electronic health record and remote data. In the transition to a new normal, our support of the Research Community specifically addresses vulnerable groups, e.g., early-stage investigators (ESIs) and translational researchers without access to clinical research infrastructure. This Core will support approaches that can be nimble in response to rapid changes and are more resilient than before the pandemic. To advance the next generation of clinical research, we propose to catalyze the work of our Research Community through the following aims: 1) Provide expertise in study design, methodology, outcomes, and statistical analysis planning, a) address elements relevant to all projects (e.g., inclusion, safety, recruitment, assessment, retention, and a priori analysis plan development) and contingency plans in a project specific Virtual Playbook, b) work closely with the Community Advisory Board (CAB) and the Resource Core to help users design research that incorporates patient and other stakeholders' perspectives, c) integrate, as needed, expert input on adaptive/pragmatic study design, epidemiology, behavioral science, nutritional science, economic evaluation, policy analysis, genomics, bioinformatics, and clinical informatics; 2) Facilitate access to and utilization of existing disease-specific databases, registries, and clinical cohorts; 3) Promote safe and responsible data management, a) provide access to database specialists who can advise or lead database construction and serve as a hub to organize institutional resources for database management, b) provide recommendations for data management, addressing complexities involved in combining different data streams (e.g., neighborhood- and individual-level; self-reported and performance-based; data from mobile devices, web-based interfaces, and wearable sensors), c) develop specific data flow plans and complete data management checklists for each project; 4) Assist research teams in completing rigorous statistical analyses that maximize the potential of study data, a) execute statistical analysis plans and collaborate with teams to interpret results, b) support manuscript and grant development, c) refine and apply sophisticated analytic approaches tailored to data that are the focus of the Resource Core; 5) Enhance the methodologic training environment, a) mentor and collaborate to enhance the capabilities ESIs and established investigators, b) provide formal educational activities and events for our Research Community and all CCCRs. This Core will provide a pandemic-responsive infrastructure that supports meaningful and efficient collaboration with CCCR users and their teams, helping to advance clinical research and increase productivity in this new era.

CCCR方法学核心的使命是-在新冠肺炎时代-加速临床研究 在 通过提供最先进的专业知识来设计和开发有影响力的 研究和创新干预，并执行严格的数据收集，管理和分析 .而 大多数COVID-19的影响是负面的，许多反应是积极的，导致创造性的解决方案， 知情同意、研究访视以及使用电子健康记录和远程数据。在向新的 正常情况下，我们对研究社区的支持专门针对弱势群体，例如，早期 研究人员（ESI）和翻译研究人员无法访问临床研究基础设施。这一核心 将支持能够灵活应对快速变化的方法，并且比以前更具弹性， 流行病为了推进下一代临床研究，我们建议促进我们的工作， 研究社区通过以下目标：1）提供研究设计，方法， 成果和统计分析规划，a）处理与所有项目有关的要素（例如，包容性、安全性 招聘、评估、保留和先验分析计划制定）和项目中的应急计划 具体的虚拟行动手册，B）与社区咨询委员会（CA B）和资源核心紧密合作， 帮助用户设计研究，纳入病人和其他利益相关者的观点，c）整合， 需要，专家对适应性/实用性研究设计的投入，流行病学，行为科学，营养 科学、经济评估、政策分析、基因组学、生物信息学和临床信息学; 2）促进 访问和利用现有的疾病特异性数据库、登记和临床队列; 3）促进安全 和负责的数据管理，a）提供访问数据库专家谁可以建议或领导数据库 建设和作为一个枢纽，组织机构资源进行数据库管理，B）提供 数据管理建议，解决合并不同数据流所涉及的复杂性 (e.g.,社区和个人水平;自我报告和基于性能;来自移动的设备的数据， 基于网络的接口和可穿戴传感器），c）制定具体的数据流计划和完整的数据 管理每个项目的检查表; 4）协助研究团队完成严格的统计分析 最大限度地发挥研究数据的潜力，a）执行统计分析计划，并与团队合作， 解释结果，B）支持论文和基金开发，c）完善和应用复杂分析 根据资源核心的重点数据量身定制的方法; 5）加强方法培训 环境，a）指导和协作以增强环境服务机构和既定调查人员的能力，B） 为我们的研究社区和所有CCCR提供正式的教育活动和事件。这一核心将 提供应对流行病的基础设施，支持与CCCR进行有意义和有效的合作 用户和他们的团队，帮助推进临床研究和提高生产力在这个新时代。