Racial/ethnic and socioeconomic disparities in biologic and clinical SLE outcomes

描述（由申请方提供）：拟定的纵向加州狼疮流行病学研究（CLUES）队列将来自成功的加州狼疮监测项目（CLSP），这是一项由疾病控制和预防中心（CDC）资助的基于人群的登记研究（n=890）。CLUES的目标是：（1）招募和跟踪CLSP中确定的个体，以建立一个基于人群的纵向队列，其中非洲裔美国人，亚洲人，西班牙裔和高加索人个体具有独特的平衡;（2）创建最先进的临床和患者报告数据库，其中包括进一步定义和了解狼疮流行病学和结局所需的信息;（3）建立一个最先进的狼疮生物标本库，其中包括来自CLUES队列中个体的血清和DNA;（4）进行高影响力的研究调查，以促进对狼疮种族/民族和社会经济差异的理解;和（5）支持在加州和全国范围内合作使用CLUES数据和生物标本库进行研究调查，并与社区和组织合作伙伴合作，以确保研究结果影响公共卫生。将进行创新的研究调查，以检查表观遗传特征随时间的变化，并确定表观遗传因素是否有助于狼疮结局的种族差异;调查狼疮患者报告的新结局（PRO）以及这些PRO中的种族/种族差异;并使用新的质量措施来了解和量化狼疮肾炎是如何评估和治疗在不同的种族/美国医疗体系中的少数民族。这一系列的项目，从分子到卫生系统的水平，说明了这一应用的独特功能之一。其他新的方面是患者群体的多样性;研究者在患者队列研究的开发和维护、狼疮的临床护理以及狼疮临床、遗传学和PRO研究方面的经验深度; 需要收集的数据多样性，以解决具体的调查，并为其他调查人员和未来的合作建立资源;并计划从仔细表征和多样化的狼疮队列中收集生物标本。我们将从CLSP队列中招募个体参与系统性年度电话调查，其中包括疾病状态、PRO和自我报告的健康利用信息。一组400名患者，来自四个种族/民族组（非洲裔美国人，亚洲人，西班牙裔和高加索人）各100名，也将接受更深入的研究。该组将进行两次研究诊所访视，包括由主要狼疮医生进行详细的临床检查，收集生物标本，完成PRO测量和收集医疗记录。拟议的项目利用了优秀的机构资源，并建立在研究者的良好记录基础上，（1）建立成功的行政和管理基础设施，包括强大的咨询委员会，（2）开发和维护纵向队列研究，以及（3）创建有效的共享临床数据和生物标本资源的系统。

DESCRIPTION (provided by applicant): The proposed longitudinal California Lupus Epidemiology Study (CLUES) cohort will derive from the successful California Lupus Surveillance Project (CLSP), a Centers for Disease Control and Prevention (CDC)-funded population-based registry (n=890). Aims of CLUES are to: (1) Recruit and follow individuals identified in the CLSP to establish a population-based, longitudinal cohort with a unique balance of African American, Asian, Hispanic, and Caucasian individuals; (2) Create a state-of-the-art clinical and patient-reported data repository that includes information needed to further define and understand the epidemiology and outcomes of lupus; (3) Establish a state-of-the-art lupus biospecimen repository that includes serum and DNA from individuals in the CLUES cohort; (4) Perform high-impact research investigations to advance understanding of racial/ethnic and socioeconomic disparities in lupus; and (5) Support collaborative use of the CLUES data and biospecimen repositories for research investigations both in California and nationally, and work with community and organizational partners to ensure that study findings impact public health. Innovative research investigations will be undertaken to examine changes in epigenetic profiles over time and determine whether epigenetic factors contribute to ethnic differences in lupus outcomes; investigate novel patient-reported outcomes (PROs) in lupus and racial/ethnic differences in those PROs; and use new quality measures to understand and quantify how lupus nephritis is evaluated and treated in different racial/ethnic groups in the U.S. health care system. This range of projects, from the molecular to the health systems level, illustrates one of the unique features of this application. Other novel aspects are the diversity of the patient population; the depth of experience of the investigators with development and maintenance of patient cohort studies, clinical care of lupus, and lupus clinical, genetics, and PRO research; the diversity of data to be collected both to address specific investigations and to establish a resource for other investigators and future collaborations; and plans to collect biospecimens from the carefully characterized and diverse lupus cohort. We will recruit individuals from the CLSP cohort to participate in systematic annual telephone surveys that include information on disease status, PROs, and self-reported health utilization. A group of 400 patients, 100 from each of four racial/ethnic groups (African American, Asian, Hispanic, and Caucasian), will also undergo more intensive study. This group will have two research clinic visits that will include detailed clinical examinations by leading lupus physicians, collection of biologic specimens, completion of PRO measures, and collection of medical records. The proposed project leverages outstanding institutional resources and builds on the proven track-record of the investigators in (1) building successful administrative and management infrastructures, including a strong Advisory Committee, (2) developing and maintaining longitudinal cohort studies, and (3) creating effective systems for sharing clinical data and biospecimen resources.