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

描述(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老龄化而增加。LUTD的症状诊断和治疗费用高昂；现有的治疗干预措施既不是非常有效也不持久，而且有其自身的副作用。从患者的角度来看，结果不令人满意是常见的，这并不令人惊讶。总体而言，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。以前在这一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，并因对LUTD的起源和自然历史的不完全了解而受到阻碍。全面重新评估LUTD的症状和更精确地描述LUTD患者的症状(表型)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。这个项目的目的是建立DCC，它将与NIDDK和几个临床站点建立合作关系，这些站点将把有LUTD症状的患者纳入精心设计的研究。 有两个具体目标。首先是发展基础设施，以支持整个研究网络。这将包括以下领域的专门知识和经验：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，以及在应用各种严格统计分析方法方面公认的卓越表现。 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症状进行量化；2)使用聚类分析、分类和回归树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入的表型分析；以及3)确定与症状开始、加重、缓解、缓解和进展相关的生物标记物。

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.