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: 8443662
• 负责人: Robert M Merion
• 金额: $ 30.99万
• 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/8443662
• 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）：较低的尿路功能障碍（LUTD）很常见，随着人口年龄的增长，其发病率和患病率正在增加。 LUTD的症状在诊断和治疗中成本高昂；现有的治疗干预既不是高效也不耐用的，也没有自己的副作用。毫不奇怪，从患者的角度来看，结果不令人满意。总的来说，这些挑战代表了与国家糖尿病和消化研究所和肾脏疾病（NIDDK）的任务一致的研究的重要目标。以前改善该领域的患者报告结果（PRO）的努力已依赖于不完全的症状测量量表，并因对LUTD的起源和自然历史的不了解而受到阻碍。对LUTD症状宇宙的全面重新评估以及LUTD症状（表型）患者的更精确表征可能会提供重要的新见解，最终导致改善患者的生活。 NIDDK赞助的较低尿路功能障碍研究网络（LURN）的症状包括一个数据协调中心（DCC），可作为该网络的项目和数据管理Nexus。该项目的目的是建立DCC，该DCC将与NIDDK和几个临床部位建立合作关系，这些临床部位将使Patiets征集LUTD症状进行精心设计的研究。 有两个具体的目标。首先是开发基础架构以支持整个研究网络。这将包括在研究协调，沟通和物流，研究设计，数据库设计和集中数据管理，研究监测，质量保证，生物样品处理和跟踪方面的专业知识和经验，并在广泛的统计严格分析方法方面的应用方面认识到卓越。 第二个特定目的体现了该项目的科学目标，包括：1）使用最先进的规模开发和统计分析方法来定量男女中LUTD症状的开发； 2）使用聚类分析，分类和回归树以及其他数据挖掘方法开发具有相关LUTD症状的患者队列的深层表型； 3）鉴定与症状启动，加剧，缓解，缓解和进展有关的生物标志物。