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: 10246242
• 负责人: Robert M Merion
• 金额: $ 12.02万
• 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/10246242
• 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; care outcomes; clinical phenotype; clinical research site; cohort; data management; design; dissemination research; 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， 研究人员将推进下尿路症状（LUTS）研究参与者的亚型分型， 预期将鉴定出临床上有用的患者亚型。研究工作将继续包括 分析来自LURN I的数据和生物标本，并开发额外的、新的和新颖的合作项目， 研究，以进一步提高我们对下尿路功能障碍的理解，两者都旨在产生 可以告知未来临床研究的发现（例如，临床治疗试验），并最终改善临床 管理和患者结果。 研究还将完善和评估LURN I中确定的患者集群的纵向性能 分型，包括对治疗的反应。我们将结合LURN I器官为基础的见解 诊断初步研究和生物标志物初步研究。我们将评估LURN综合评估， 在LUTS严重程度低于 LURN I的三级护理环境。 与《外地住房准备金》中对利比里亚难民救济和重建网络第二个供资周期的描述相一致， 建议是更好地定义LUTS患者的临床表型，更好地描述影响， 症状的多样性，并开发新的以患者为中心的工具，以改善临床 症状，所有这些都是为了为未来的临床研究提供信息并改善患者护理和结果。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 为所有LURN研究的研究中心和NIDDK项目科学家提供支持。提案团队是 将此响应提交至RFA-DK-18-511，以继续作为网络的DCC。