SEARCH for Diabetes in Youth Registry Study, Phase 4: Washington Center

青少年登记研究中的糖尿病搜索，第 4 阶段：华盛顿中心

• 批准号: 9127727
• 负责人: Catherine Pihoker
• 金额: $ 37.74万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-30 至 2020-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9127727
• 关键词: SEARCH; Diabetes; Youth; Registry; Study

 DESCRIPTION (provided by applicant): The SEARCH for Diabetes in Youth Study documented a 31% increase in the prevalence of type 2 diabetes (T2D) between 2001 and 2009, as well as an increase of 21 % in the prevalence of type 1 diabetes (T1D). Increases occurred across most but not all major subgroups of age, sex and race/ethnicity. Further, we documented an annual increase in the incidence of T1D among non-Hispanic White (NHW) youth of approximately 2.7% per year. In contrast, studies from Europe suggest that incidence of T1D may be stabilizing. Thus, compelling questions remain regarding long term trends in incidence and prevalence for both T1 and T2 in youth, particularly among various racial and ethnic population subgroups. Ongoing, efficient surveillance of diabetes diagnosed in youth is essential to inform health care systems and generate testable hypotheses related to the natural history of diabetes in youth. SEARCH is uniquely positioned to address these critical questions through continued surveillance of childhood diabetes employing our well-established infrastructure for surveillance, and its highly experienced, collaborative and multi-disciplinary investigative team. Therefore, in response to RFA-DP-15-002, Component A, we propose the continuation of the SEARCH for Diabetes in Youth Registry Study (SEARCH Phase 4) during which we will continue to ascertain newly diagnosed incident diabetes cases throughout the study period and one additional prevalent cohort (index year 2017) for youth age < 20 years across our five well-established geographically dispersed Study Centers. Our approach is informed by our substantial accrued experience that allows us to conduct surveillance work in a highly efficient manner. We frame our surveillance as an innovative three-tiered approach, starting with the most broad based and cost efficient approach at the highest tier (tier 1) and becoming the most focused in tier 3, with each tier optimizing use of electronic health records (EHRs). Specific Aims are: Aim 1: TIER 1 SURVEILLANCE (Prevalence)- To ascertain cases of prevalent diabetes in calendar year 2017 among youth age < 20 years at diagnosis; Aim 2: TIER 2 SURVEILLANCE (Incidence)- To continue to ascertain newly diagnosed (2015-2020) incident diabetes cases in youth age < 20 years; Aim 3: TIER 3 SURVEILLANCE (Clinical Characteristics) - To confirm classification of diabetes type using biochemical markers, to describe selected clinical characteristics at diagnosis, and to maintain an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants; Aim 4: OPERATIONAL EFFICIENCY: To optimize efficiency of the SEARCH Surveillance activities through targeted development and validation projects designed to utilize relevant electronic health data to operationalize each of the three tiers of surveillance. Thus, the well-established and highly productive SEARCH team is uniquely positioned to provide critical information on the prevalence, incidence and early clinical course of diabetes in youth.

 描述(由申请人提供)：寻找青年糖尿病研究记录了2001至2009年间2型糖尿病(T2D)的患病率增加了31%，而1型糖尿病(T1D)的患病率增加了21%。在年龄、性别和种族/族裔的大多数但不是所有主要分组中都出现了增加。此外，我们记录了非西班牙裔白人(NHW)青年中T1D发病率的年增长率约为2.7%。相比之下，来自欧洲的研究表明，T1D的发病率可能正在稳定下来。因此，关于青年中T1和T2的发病率和流行率的长期趋势，特别是在不同种族和族裔人口亚群中的发病率和流行率，仍然存在令人信服的问题。对青年中诊断的糖尿病进行持续、有效的监测对于向卫生保健系统提供信息并产生与青年糖尿病自然病史有关的可检验假说至关重要。Search通过利用我们成熟的监测基础设施及其经验丰富、协作和多学科的调查团队，通过对儿童糖尿病的持续监测，处于独特的地位，能够解决这些关键问题。因此，针对RFA-DP-15-002，A部分，我们建议继续进行青年糖尿病登记研究(搜索阶段4)，在此期间，我们将在整个研究期间继续确定新诊断的糖尿病病例，并在我们五个成熟的地理分散的研究中心中增加一个20岁及20岁的流行队列(指数年2017)。我们的做法是基于我们积累的丰富经验，使我们能够以高效的方式开展监测工作。我们将我们的监测作为一种创新的三层方法，从最高层(第一层)基础最广泛和成本效益最高的方法开始，在第三层成为最专注的方法，每一层都优化电子健康记录(EHR)的使用。具体目标是：目标1：一级监测(流行率)--确定2017年日历年确诊年龄及20岁青年中的糖尿病流行病例；目标2：二级监测(发病率)--继续确定新诊断的(2015-2020年)20岁青年糖尿病发病病例；目标3：一级监测(临床特征)--使用生化标记物确认糖尿病类型分类，描述诊断时选定的临床特征，并通过储存生物样本和保持与潜在研究参与者的联系，维持有助于开展更详细辅助研究的基础设施；目标4：业务效率：通过有针对性的开发和验证项目来优化搜索监测活动的效率，该项目旨在利用相关的电子健康数据来实施三级监测中的每一级。因此，这支久负盛名的高效搜索团队在提供有关青少年糖尿病患病率、发病率和早期临床病程的关键信息方面具有独特的地位。