Pragmatic Trials in Maintenance Hemodialysis

维持性血液透析的实用试验

• 批准号: 8738076
• 负责人: Laura M Dember
• 金额: $ 20万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8738076
• 关键词: Adoptive Transfer; Animal Model; Anti-Inflammatory Agents; Anti-inflammatory; Area; Attenuated; Autoimmunity; Biological; Biological Markers; Blocking Antibodies; Blood; Blood Tests; CD4 Positive T Lymphocytes; Cell Culture Techniques; Cells; Cellular biology; Cerebrospinal Fluid; Clinical Research; Cytokine Network Pathway; Data; Development; Discipline; Disease; Employee Strikes; Ensure; Environment; Event; Experimental Autoimmune Encephalomyelitis; Faculty; Goals; Hemodialysis; Human; Immune; In Vitro; Inflammation; Inflammatory; Interferon-beta; Interferons; Interleukin-10; Knockout Mice; Link; Longitudinal Studies; Maintenance; Mentors; Molecular; Multiple Sclerosis; Mus; Outcome; Pathway interactions; Patients; Pharmaceutical Preparations; Play; Publishing; Regulation; Relapsing-Remitting Multiple Sclerosis; Research; Research Institute; Research Personnel; Role; STAT1 gene; STAT4 gene; Science; Serum; Signal Pathway; Signal Transduction; Techniques; Therapeutic; Tissues; Training; Transcriptional Regulation; Work; abstracting; active method; cell type; cohort; cytokine; effective therapy; meetings; mouse model; planetary Atmosphere; pragmatic trial; research study; response

DESCRIPTION (provided by applicant): This application seeks to conduct a large, pragmatic clinical trial demonstration project within the NIH Health Care Systems (HCS) Research Collaboratory. The Dialysis Research Network, comprised of academic investigators and dialysis provider organizations, is proposing the "Time to Reduce Mortality in End-Stage Renal Disease (TiME)" trial. The TiME trial is a large, cluster-randomized, pragmatic trial that will evaluate the effects on survival, hospitalizations, and health-related quality of life of a systemaic implementation of a hemodialysis session duration of at least four hours for individuals with irreversible kidney failure who are initiating treatment with maintenance hemodialysis. The trial will be conducted in approximately 320 dialysis facilities owned by the two largest dialysis provider organizations in the United States. The electronic data systems of the dialysis provider organizations will be used for identification of participating dialysis facilities, for collection f trial data and outcomes, and for transmission of data to the University of Pennsylvania Clinical Research Computing Unit which will serve as the data coordinating center for the trial. The project will be implemented in two phases: the UH2 planning phase and the UH3 implementation phase, each of which has specific milestones for progress and metrics for evaluating the innovative approaches used for the trial. The Dialysis Research Network application fulfills the objectives of the NIH HCS Research Collaboratory Pragmatic Clinical Trials Demonstration Projects program. The TiME trial is pragmatic: 1) it evaluates an intervention implemented in the usual care setting, 2) it utilizes data that are obtained for routie clinical care, 3) it has minimal restrictions on eligibility, and 4) it requires no specific expertse of practitioners. The outcomes are important both clinically and from the perspective of the patient. The trial will be conducted through a partnership between academic investigators and two health care provider organizations with different business models, cultures, and electronic data systems. Innovative approaches that are relevant and applicable across a broad range of health care systems and diseases will be used for highly centralized execution of the trial, and tools wil be developed and shared with the broader research community. Thus, in addition to efficiently testing a simple but potentially high-impact intervention for patients with kidney failure, the TiM trial demonstration project will generate important advances for conducting cost-effective, large-scale clinical trials that assess the effectiveness of interventions in "real-world" settings.

描述（由申请人提供）：本申请旨在在NIH医疗保健系统（HCS）研究合作实验室内进行一项大型实用的临床试验示范项目。由学术研究人员和透析提供者组织组成的透析研究网络正在提议“降低终末期肾病死亡率的时间（TiME）”试验。TiME试验是一项大型、随机分组、实用性试验，旨在评价系统性实施持续时间至少为4小时的血液透析对开始维持性血液透析治疗的不可逆性肾衰竭患者的生存率、住院率和健康相关生活质量的影响。该试验将在美国两个最大的透析提供商组织拥有的约320家透析机构中进行。透析供应商组织的电子数据系统将用于识别参与的透析机构，收集试验数据和结局，并将数据传输至宾夕法尼亚大学临床研究计算中心，该中心将作为试验的数据协调中心。该项目将分两个阶段实施：UH2规划阶段和UH3实施阶段，每个阶段都有具体的进度里程碑和评估试验所用创新方法的指标。透析研究网络应用程序实现了NIH HCS研究合作实验室实用临床试验示范项目的目标。TiME试验是务实的：1）它评估在常规护理环境中实施的干预，2）它利用常规临床护理获得的数据，3）它对资格的限制最小，4）它不需要从业者的特定专业知识。无论从临床上还是从患者的角度来看，结果都很重要。该试验将通过学术研究者和两个具有不同商业模式、文化和电子数据系统的医疗保健提供者组织之间的合作进行。将使用在广泛的医疗保健系统和疾病中相关和适用的创新方法来高度集中地执行试验，并将开发工具并与更广泛的研究界共享。因此，除了有效地测试肾衰竭患者的简单但可能具有高影响力的干预措施外，TiM试验示范项目还将为进行具有成本效益的大规模临床试验带来重要进展，这些临床试验将评估干预措施在“现实世界”环境中的有效性。