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

描述（由申请人提供）：下尿路功能障碍（LUTD）很常见，其发病率和患病率随着人口年龄的增长而增加。LUTD的症状诊断和治疗成本很高;现有的治疗干预措施既不高效也不持久，并且有其自身的副作用。毫不奇怪，从患者的角度来看，不满意的结果是常见的。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）的使命一致的重要研究目标。以前的努力，以改善患者报告的结果（PRO）在这方面依赖于不完整的症状测量量表，并已受到阻碍的起源和LUTD的自然史的不完善的理解。对LUTD症状范围的全面重新评估和对具有LUTD症状（表型）的患者的更精确表征可能提供重要的新见解，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），作为网络的项目和数据管理中心。本项目的目的是建立DCC，DCC将与NIDDK和几个临床研究中心建立合作关系，这些临床研究中心将招募有LUTD症状的患者参加精心设计的研究。 有两个具体目标。第一是发展基础设施，以支持整个研究网络。这将包括在研究协调、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门知识和经验，以及在应用广泛的严格统计分析方法方面公认的卓越能力。 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对女性和男性的LUTD症状进行定量; 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症状的患者队列进行深度表型分析;和3）识别与症状发生、恶化、缓解、缓解和进展相关的生物标志物。

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.