Coordination for ARDS, Pneumonia, and Sepsis supporting Training, Organization and Network Efficiency (CAPSTONE)

协调 ARDS、肺炎和败血症支持培训、组织和网络效率 (CAPSTONE)

• 批准号: 10647455
• 负责人: Gordon R Bernard
• 金额: $ 228.71万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2029-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10647455
• 关键词: Acute Respiratory Distress Syndrome; Adherence; Attenuated; Big Data; Biological; Biometry; California; Caring; Classification; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Cognitive; Communication; Communities; Compensation; Complex; Contracts; Critical Illness; Data; Data Collection; Dedications; Development; Electronic Health Record; Enrollment; Ensure; Evolution; Failure; Foundations; Goals; Grouping; Heterogeneity; Image; Individual; Infrastructure; Investigation; Knowledge; Leadership; Manuals; Measurement; Measures; Medical; Methods; Mission; Monitor; Morbidity - disease rate; Operations Research; Outcome; Participant; Patients; Pharmacotherapy; Phenotype; Pneumonia; Population; Precision therapeutics; Process; Protocols documentation; Recovery; Reporting; Reproducibility; Research; Research Design; Research Infrastructure; Risk Factors; San Francisco; Science; Security; Sepsis; Site; Standardization; Statistical Data Interpretation; Syndrome; Therapeutic; Training; Training Support; Translating; Translational Research; Trust; Universities; Work; biobank; career development; clinical center; cohort; community engagement; data infrastructure; data management; data modeling; data quality; design; efficacious treatment; electronic consent; experience; improved; individual patient; innovation; knowledge base; mortality; multimodality; novel therapeutics; operation; patient population; patient subsets; performance site; personalized management; phenotyping algorithm; point of care; precision medicine; profiles in patients; prognostic; protocol development; recruit; skill acquisition; skills; success; synergism; targeted treatment; treatment response; virtual

The ARDS, Pneumonia, and Sepsis (APS) Coordinating Center will support a highly functional and integrated clinical and translational research infrastructure that will enhance the quality and scientific rigor of the research conducted by the APS Phenotyping Consortium. We are a team composed of leading content and methods experts at Vanderbilt, Johns Hopkins, and University of California San Francisco. We will provide Coordination for ARDS, Pneumonia, and Sepsis supporting Training, Organization and Network Efficiency: ‘CAPSTONE’. We will support the clinical centers (CCs) in enrolling and sustaining a diverse cohort; enable the efficient and standardized capture of multi-modal cohort data with repeated measurements; model the data to understand mechanistic underpinnings of APS, including the interplay of underlying and static risk factors; and segment the population into similar prognostic and predictive phenotypes. This will enable scientific progress towards a deeper mechanistic understanding of critical illness syndromes and recovery. Functionally, we will 1) Implement the study design, data capture, and statistical analysis unit. Coordinate protocol development; establish a REDCap-based data collection, management, and security framework; conduct and support analyses; generate reports; make curated data widely available for research through a facilitated storefront; 2) Implement the clinical research management unit. Maintain cohort integrity and adherence to the protocol and manual of operations, perform routine monitoring of data quality and site performance; training of study staff; image and biospecimen management. Support site communications; facilitate recruitment and retention; and 3) Implement the stakeholder engagement and development unit. Establish bidirectional, longitudinal engagement from diverse communities; help CCs build and sustain trust; ensure strengths of each CC are nurtured and shared; facilitate dissemination of findings; support skills and career development among research teams. Our efforts will expand foundational work on APS phenotyping, identify gaps, and help create methods for redefining critical illness syndromes with the ultimate goal of improving and personalizing management strategies that will curtail the devastating morbidity and mortality caused by APS.

ARDS、肺炎和脓毒症（APS）协调中心将支持一个高度功能化的 以及整合的临床和转化研究基础设施，这将提高质量， APS表型鉴定联盟进行的研究的科学严谨性。我们是一个团队 由范德比尔特、约翰霍普金斯和大学的主要内容和方法专家组成 位于加州旧金山弗朗西斯科。我们将为ARDS、肺炎和脓毒症提供协调服务 支持培训、组织和网络效率：“CAPSTONE”。我们将支持 临床中心（CC）在招募和维持多样化队列方面的作用; 标准化采集具有重复测量的多模态队列数据;对数据进行建模， 了解APS的机制基础，包括潜在风险和静态风险的相互作用 因素;并将人群划分为相似的预后和预测表型。这将 使科学进步能够更深入地了解危重疾病的机制 症状和恢复。在功能上，我们将1）实施研究设计、数据采集和 统计分析股。协调方案制定;建立基于REDCap的数据 收集、管理和安全框架;进行和支持分析;生成 报告;通过便利的店面使策展数据广泛用于研究; 2） 实施临床研究管理单元。保持队列完整性并遵守 方案和操作手册，对数据质量和研究中心进行例行监测 性能;研究人员培训;图像和生物标本管理。支持站点 沟通;促进招聘和保留;以及3）实施利益攸关方 参与和发展股。建立双向、纵向的参与， 社区;帮助CC建立和维持信任;确保每个CC的优势得到培养， 分享;促进传播调查结果;支持技能和职业发展， 研究团队。我们的努力将扩大APS表型的基础工作，确定差距， 并帮助创建重新定义危重病综合征的方法，最终目标是 改善和个性化的管理策略，将减少毁灭性的发病率， APS引起的死亡率。