SEARCH for Diabetes in Youth Coordinating Center

该方案描述了数据协调中心的开发、实施和维护 (COC)寻找青年糖尿病研究的第二阶段。搜索研究COC正在进行中 由维克森林大学医学院(WFUSM)的一组研究人员提出 对疾病控制和预防中心题为“发病率，自然”的RFA的回应 青年糖尿病的病史和生活质量“(RFA-DP-05-069)。WFUSM处于有利地位，可以为 这一能力自2001年以来一直担任搜索研究第一阶段的协调中心。这项研究是 一项由六个中心参与的研究调查了青少年糖尿病的患病率、发病率和临床表现。 -自2001年以来，按糖尿病类型、种族、性别和年龄分列的19年。来自一万多名青年的数据， 代表六个搜索中心(南部)2001年的流行案件和2002-2005年的事件案件 卡罗莱纳、辛辛那提、西雅图、南加州、科罗拉多州、夏威夷)，目前正在存储和分析 由WFUSM Search CoC提供。WFUSM将提供统计和业务支持，以解决 以下是原搜索诊所网站为第二阶段搜索提出的研究目标： 前瞻性确定2006-2008年儿童/青少年和20岁以下儿童中新诊断的糖尿病发病病例 并收集数据，以便按年龄组、性别、年龄和性别估计糖尿病发病率的时间趋势 2002-2008年期间种族/族裔和糖尿病类型；(2)对事件进行纵向跟踪 2003-2005年已招募进行检索的病例，以记录新诊断病例的演变情况 糖尿病根据临床和生化因素的演变特征及关键危险因素 糖尿病并发症，根据糖尿病类型和种族/民族；(3)评估质量的影响 青少年糖尿病护理对短期和长期结果的影响，包括完成分析工作后的生活质量 如护理质量路线图中所述，在搜索中启动，并扩大质量范围 在搜索中发起护理评估以探索患者特征的相互关系， 保健的重要领域和结果，包括血糖控制、护理满意度、接受 推荐的服务、并发症和生活质量；以及(4)开发和验证简单和低- 可用于公共卫生的青年糖尿病类型的成本病例定义和分类 监视系统。此外，WFUSM COC将制定一项计划，以确保为 用于储存和分析血液和尿液样本的搜索研究，以及用于辅助研究的DNA储存。 搜索研究的这一阶段将建立在研究第一阶段获得的知识的基础上，并将 提供有价值的临床和公共卫生信息，以解决日益严重的儿童糖尿病问题。

This proposal describes the development, implementation and maintenance of a data coordinating center (CoC) for the second phase of the SEARCH for Diabetes in Youth Study. The SEARCH study CoC is being proposed by a team of investigators from the Wake Forest University School of Medicine (WFUSM) in response to an RFA from the Centers for Disease Control and Prevention entitled, "Incidence, Natural History, and Quality of Life of Diabetes in Youth" (RFA-DP-05-069). WFUSM is well positioned to serve in this capacity, having served as the CoC for the first phase of the SEARCH study since 2001. This study was a six-center study examining the prevalence, incidence, and clinical presentation of diabetes among youth 0 - 19years by diabetes type, ethnicity, gender and age, since 2001. Data from over 10,000 youth, representing prevalent cases in 2001 and incident cases in 2002 - 2005 atthe six SEARCH centers (South Carolina, Cincinnati, Seattle, Southern California, Colorado, Hawaii), is currently being stored and analyzed by the WFUSM SEARCH CoC. The WFUSM will provide statistical and operational support to address the following study aims proposed by the original SEARCH clinic sites for the second phase of SEARCH: (1) to prospectively ascertain newly diagnosed (2006-2008) incident diabetes cases in children/youth <20 years of age and collect data that permits estimation of temporal trends in diabetes incidence by age-group, gender, race/ethnicity anddiabetes type for the period 2002 - 2008; (2)to conduct longitudinal follow-up of incident cases already recruited to SEARCH in 2003 - 2005 in order to document the evolution of newly diagnosed diabetes according to clinical and biochemical factors and characterize the evolution of key risk factors for diabetes complications, according to diabetes type and race/ethnicity; (3) to assess the impact of quality of diabetes care in youth on short- and long-term outcomes including quality of life by completing analytic work initiated in SEARCH as described in the Quality of Care Roadmap and expanding the scope of quality of care assessment initiated in SEARCH in order to explore the interrelationships of patient characteristics, important domains of health care with outcomes, including glycemic control, satisfaction with care, receipt of recommended services, complications, and quality of life; and (4) to develop and validate simple and low- cost case definitions and classifications of diabetes types in youth that can be used for public health surveillance. Additionally, the WFUSM CoC will develop a plan to secure a central laboratory for the SEARCH study for storage and analysis of blood and urine sample and storage of DNA for ancillary studies. This phase of the SEARCH study will build on the knowledge gained in the first phase of the study, and will provide valuable clinical and public health information to address the growing problem of childhood diabetes.