Continuation of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Data Coordinating Center

下尿路功能障碍症状延续研究网络 (LURN) 数据协调中心

• 批准号: 10251160
• 负责人: Robert M Merion
• 金额: $ 102.01万
• 依托单位: ARBOR RESEARCH COLLABORATIVE FOR HEALTH
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-25 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10251160
• 关键词: Ancillary Study; Bar Codes; Biological; Biological Assay; Biological Markers; Bladder; Case Report Form; Characteristics; Charge; Clinical; Clinical Management; Clinical Research; Clinical Treatment; Clinical Trials; Collaborations; Communication; Communities; Complex; Consensus; Data; Data Analyses; Data Collection; Data Coordinating Center; Development; Diagnosis; Diagnostic; Disease; Functional disorder; Funding; Future; Goals; Human Resources; Infrastructure; Institutional Review Boards; Internist; Knowledge; Lead; Leadership; Logistics; Lower urinary tract; Manuscripts; Measurement; Measures; Modeling; Monitor; Motor; National Institute of Diabetes and Digestive and Kidney Diseases; Organ; Outcome; Participant; Patient Care; Patient Monitoring; Patient Self-Report; Patient-Focused Outcomes; Patients; Performance; Phase; Phenotype; Physiological; Pilot Projects; Plasma; Policies; Population; Process; Publications; Reporting; Research; Research Design; Research Personnel; Sampling; Scientist; Secure; Self Assessment; Sensory; Severities; Site; Subgroup; Surveys; Symptoms; System; Testing; Time; Treatment outcome; Urethra; Urinary Tract Finding; Urinary tract; Urodynamics; Urologist; Woman; Work; Writing; base; biomarker signature; care outcomes; clinical phenotype; clinical research site; cohort; data management; design; expectation; experience; improved; insight; instrument; lower urinary tract symptoms; meetings; men; novel; patient subsets; protein biomarkers; protocol development; quality assurance; recruit; research study; response; symposium; symptom treatment; tertiary care; tool; treatment response; treatment trial; urinary; web site

Project Summary In the Continuation of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN II), the investigators will advance the subtyping of study participants with Lower Urinary Tract Symptoms (LUTS) with the expectation that clinically useful patient subtypes will be identified. Research efforts will include continued analysis of data and biospecimens from LURN I and development of additional, new and novel collaborative studies to further improve our understanding of lower urinary tract dysfunction, both designed to generate findings that may inform future clinical studies (e.g., clinical treatment trials) and ultimately improve clinical management and patient outcomes. Studies will also refine and evaluate the longitudinal performance of clusters identified in LURN I for patient subtyping, including response to treatment. We will incorporate insights from the LURN I organ-based diagnostics pilot study and biomarker pilot studies. We will evaluate the LURN Comprehensive Assessment of Self-reported Urinary Symptoms (CASUS) instrument in populations with lesser severity of LUTS than seen in the tertiary care setting in LURN I. Consistent with the description in the RFA for this second funding cycle of LURN, the primary goal of this proposal is to better define clinical phenotypes of patients with LUTS, to better describe the impact and diversity of symptoms, and to develop new patient-centric tools for improved measurement of clinical symptoms, all with the goals of informing future clinical studies and improving patient care and outcomes. It is anticipated that the network will consist of up to six clinical sites and a single data coordinating center (DCC). The DCC for the LURN study is charged with providing coordination, communications and logistical support, clinical study design, centralized data management, biosample management, quality assurance, and analytical support to the research sites and the NIDDK Project Scientist for all LURN studies. The proposing team is submitting this response to RFA-DK-18-511 to continue as the DCC for the network.

项目摘要 在下尿路功能障碍症状研究网络(Lurn II)的延续中， 研究人员将推进具有下尿路症状(LUTS)的研究参与者的亚型 对临床有用的患者亚型将被识别的期望。研究工作将包括继续 来自Lurn I的数据和生物谱的分析以及额外的、新的和新的协作的开发 进一步提高我们对下尿路功能障碍的理解的研究，两者都旨在产生 可能为未来的临床研究(例如，临床治疗试验)提供信息并最终改善临床的研究结果 管理和患者结果。 研究还将改进和评估Lurn I中为患者确定的集群的纵向性能 分型，包括对治疗的反应。我们将吸收来自Lurn I器官的见解 诊断学先导研究和生物标志物先导研究。我们将对Lurn综合评估进行评估 自述尿路症状(CAUS)测试仪在下尿路感染严重程度低于 Lurn I中的三级护理环境。 与RFA中对Lurn第二个供资周期的描述一致，本报告的主要目标是 建议更好地定义LUTS患者的临床表型，以更好地描述其影响和 症状的多样性，并开发新的以患者为中心的工具，以改进临床测量 症状，所有这些都是为了向未来的临床研究提供信息，并改善患者护理和结果。它是 预计该网络将由多达六个临床站点和一个数据协调中心(DCC)组成。 Lurn研究的DCC负责提供协调、通信和后勤支持， 临床研究设计、集中数据管理、生物样本管理、质量保证和分析 为研究站点和NIDDK项目科学家提供所有Lurn研究的支持。求婚团队是 将此答复提交给RFA-DK-18-511，以继续担任网络的DCC。