Clinical Core

项目总结临床核心 临床核心的目标是：1)从Myalgic获得必要的样本和相关的临床数据 脑脊髓炎/慢性疲劳综合征(ME/CFS)患者和健康受试者队列支持 拟议的ME/CFS合作研究中心(ME/CFS CRC)的研究项目，以及2)参与 ME/CFS患者和倡导社区通过在线平台和外展。临床核心将是 总部设在贝特曼·霍恩卓越中心(BHC)，这是一家以患者为中心的研究和临床护理中心 重点关注改善ME/CFS的临床管理和促进生物标志物的研究 疾病的发现和机制。核心将实施科目征聘的标准化程序， 登记和临床标本收集、临床数据获取(与数据管理协调 和协调中心)和主题跟进。将实施临床评估，客观量化 直立不耐受、睡眠不清爽和认知效率。它还将监督存储和分发 向ME/CFS CRC调查人员提供临床样本。临床核心还将利用BHC在患者方面的专业知识 参与及其由患者合作伙伴和倡导者组成的广泛网络，以促进社区对 拟议的研究和保留招募的受试者。一名社区参与协调员将与 招募ME/CFS患者定期自我跟踪，通过在线App与《We Are Curious》合作 平台、症状和治疗，以及日常活动、饮食干预和环境 暴露，在整个研究期间提供支持和指导，以便于保留。这个 临床核心将由露辛达·贝特曼博士和苏珊娜·D·弗农博士领导，他们都具有丰富的经验和 尊敬的ME/CFS临床和研究团体成员。在他们的监督下，临床核心 将通过加强患者参与和受试者参与来解决ME/CFS CRC的主题， 改进样本和临床数据收集，确保有效选择受试者，并促进获取 健壮且相关的患者参数。具体目标是：1)识别、转介和登记患者 新发病的ME/CFS以及年龄、种族和性别匹配的对照，用于纵向临床跟踪和序列 样本采集；2)进行临床评估，客观确定疲劳和日常功能，术后 使用常见数据显示劳累乏力、睡眠不清新、认知障碍和立位不适 要素、标准化问卷和工具；3)监督临床表型的存储和共享 和生物样本数据，与数据管理和协调中心(DMCC)协调；4) 与We Are Curious和MEAction团体合作开发问卷、标签和跟踪系统，以 通过ME/CFS反映患者的症状和经历，并将患者伙伴与临床和科学联系起来 通过教育和外展建立团队。

PROJECT SUMMARY CLINICAL CORE The goals of the Clinical Core are 1) to accrue the necessary samples and associated clinical data from Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients and healthy subject cohorts to support the research projects of the proposed ME/CFS Collaborative Research Center (ME/CFS CRC), and 2) to engage the ME/CFS patient and advocate community through online platforms and outreach. The Clinical Core will be based at the Bateman Horne Center of Excellence (BHC), a patient-centered research and clinical care center focused specifically on improving the clinical management of ME/CFS and fostering research into biomarker discovery and mechanisms of disease. The Core will implement standardized processes for subject recruitment, enrollment and clinical specimen collection, clinical data acquisition (in coordination with the Data Management and Coordination Center) and subject follow up. It will implement clinical evaluation to objectively quantify orthostatic intolerance, unrefreshing sleep and cognitive efficiency. It will also oversee storage and distribution of clinical samples to ME/CFS CRC investigators. The Clinical Core will also leverage BHC's expertise in patient engagement and its extensive network of patient partners and advocates to facilitate community support for the proposed research and retention of recruited subjects. A community engagement coordinator will work with enrolled ME/CFS patients to regularly self-track, through online App in collaboration with “We are Curious” platform, their symptoms and treatments, along with daily activity, dietary interventions, and environmental exposures, providing support and guidance throughout to facilitate retention throughout the study period. The Clinical Core will be led by Drs. Lucinda Bateman and Suzanne D. Vernon, both deeply experienced and respected members of the ME/CFS clinical and research communities. Under their oversight, the Clinical Core will address the theme of the ME/CFS CRC by enhancing patient engagement and subject participation, improving sample and clinical data collection, ensuring efficient selection of subjects, and facilitating acquisition of robust and relevant patient parameters. The Specific Aims are: 1) To identify, refer and enroll patients with new-onset ME/CFS along with age, race and sex-matched controls for longitudinal clinical tracking and serial sample acquisition; 2) To conduct clinical evaluations to objectively define fatigue and daily function, post- exertional malaise, unrefreshing sleep, cognitive impairment and orthostatic intolerance using common data elements, standardized questionnaires and devices; 3) To oversee storage and sharing of clinical phenotype and biological sample data in coordination with the Data Management and Coordination Center (DMCC); and 4) To partner with We are Curious and MEAction groups to develop questionnaires, tags and tracking systems that reflect patient symptoms and experiences with ME/CFS, and bridge patient partners and the clinical and scientific teams through education and outreach.