Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN)Data Coordinat

下尿路功能障碍的症状研究网络 (LURN) 数据协调

• 批准号: 8704930
• 负责人: Robert M Merion
• 金额: $ 31.27万
• 依托单位: ARBOR RESEARCH COLLABORATIVE FOR HEALTH
• 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 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8704930
• 关键词: Adherence; Adverse effects; Affect; Age; Ancillary Study; Area; Bar Codes; Biological Markers; Biometry; Blood; Calendar; Case Report Form; Charge; Classification; Clinical Investigator; Clinical Research; Cluster Analysis; Committee Members; Communication; Confidentiality; Data; Data Base Management; Data Collection; Data Coordinating Center; Data Element; Data Quality; Development; Diabetes Mellitus; Diagnosis; Digestive System Disorders; Disease; Disease remission; Electronics; Enrollment; Ensure; Evaluation; Functional disorder; Gap Junctions; Goals; Health; Housing; Human Resources; Incidence; Institutes; Investigational New Drug Application; Kidney Diseases; Laboratories; Logistics; Lower urinary tract; Maintenance; Manuals; Measurement; Methods; Mission; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Office of Administrative Management; Outcome; Patient Outcomes Assessments; Patients; Phenotype; Population; Prevalence; Privacy; Procedures; Process; Publications; Questionnaires; Records; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Safety; Sampling; Scientist; Site; Surveys; Symptoms; System; Targeted Research; Therapeutic Intervention; Training and Education; Trees; United States Food and Drug Administration; Update; Urine; Woman; clinical research site; cohort; data management; data mining; database design; design; dissemination research; experience; follow-up; improved; insight; lower urinary tract symptoms; meetings; men; operation; quality assurance; repository; research study; sample collection; symposium; tool; web site

DESCRIPTION (provided by applicant): Lower urinary tract dysfunction (LUTD) is common, and its incidence and prevalence are increasing as the population ages. Symptoms of LUTD are costly to diagnose and treat; existing therapeutic interventions are neither highly effective nor durable and have side effects of their own. Not surprisingly, unsatisfactory outcomes from the patient perspective are common. Collectively, these challenges represent important targets of research that are consistent with the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Previous efforts to improve patient reported outcomes (PRO) in this area have relied on incomplete symptom measurement scales and have been hampered by imperfect understanding of the origin and natural history of LUTD. Comprehensive re-evaluation of the symptom universe of LUTD and more precise characterization of patients with symptoms of LUTD (phenotyping) may provide significant new insights, leading ultimately to improved patient lives. The NIDDK-sponsored Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) includes a Data Coordinating Center (DCC) to serve as the project and data management nexus for the network. The purpose of this project is to establish the DCC, which will form a collaborative relationship with NIDDK and several clinical sites that will enroll patiets with symptoms of LUTD into carefully designed studies. There are two specific aims. The first is to develop the infrastructure to support the entire research network. This will include expertise and experience in the areas of research coordination, communications and logistics, study design, database design and centralized data management, study monitoring, quality assurance, biosample handling and tracking, and recognized excellence in the application of a wide range of statistically rigorous analysis methods. The second specific aim embodies the scientific goals of the project, including: 1) development of PRO measurement tools to quantitate symptoms of LUTD in women and men using state-of-the-art scale development and statistical analysis methods; 2) development of deep phenotyping of patient cohorts with relevant LUTD symptoms using cluster analysis, classification and regression trees, and other data mining methods; and 3) identification of biomarkers related to symptom initiation, exacerbation, mitigation, remission, and progression.

描述（由申请人提供）：下尿路功能障碍（LUTD）很常见，并且其发病率和患病率随着人口老龄化而增加。 LUTD 症状的诊断和治疗成本高昂；现有的治疗干预措施既不高效也不持久，而且本身有副作用。毫不奇怪，从患者角度来看，不满意的结果很常见。总的来说，这些挑战代表了与国家糖尿病、消化和肾脏疾病研究所 (NIDDK) 的使命相一致的重要研究目标。以前在该领域改善患者报告结果 (PRO) 的努力依赖于不完整的症状测量量表，并且由于对 LUTD 的起源和自然史的不完全理解而受到阻碍。对 LUTD 症状范围的全面重新评估以及对有 LUTD 症状的患者进行更精确的表征（表型分析）可能会提供重要的新见解，最终改善患者的生活。 NIDDK 赞助的下尿路功能障碍症状研究网络 (LURN) 包括一个数据协调中心 (DCC)，作为该网络的项目和数据管理纽带。该项目的目的是建立 DCC，该中心将与 NIDDK 和多个临床中心建立合作关系，将有 LUTD 症状的患者纳入精心设计的研究中。 有两个具体目标。首先是开发基础设施来支持整个研究网络。这将包括研究协调、通信和后勤、研究设计、数据库设计和集中数据管理、研究监测、质量保证、生物样本处理和跟踪等领域的专业知识和经验，以及在广泛的统计应用中公认的卓越表现。严谨的分析方法。 第二个具体目标体现了该项目的科学目标，包括：1）开发PRO测量工具，使用最先进的量表开发和统计分析方法来量化女性和男性的LUTD症状； 2) 使用聚类分析、分类和回归树以及其他数据挖掘方法对具有相关 LUTD 症状的患者群体进行深度表型分析； 3) 鉴定与症状发生、恶化、缓解、缓解和进展相关的生物标志物。