Clinical Core

临床核心项目总结 临床核心的目标是：1）从Myalgic收集必要的样本和相关临床数据 脑脊髓炎/慢性疲劳综合征（ME/CFS）患者和健康受试者队列，以支持 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患者和倡导者社区通过在线平台和外展。临床核心将是 贝特曼霍恩卓越中心（BHC），以患者为中心的研究和临床护理中心 特别关注改善ME/CFS的临床管理，并促进生物标志物的研究 疾病的发现和机制。核心将实施受试者招募的标准化流程， 入组和临床标本采集、临床数据采集（与数据管理部门协调 和协调中心）和受试者随访。它将实施临床评估，以客观量化 直立耐受不良、睡眠不佳和认知效率。它还将监督存储和分配 向ME/CFS CRC研究者提供临床样本。临床核心还将利用BHC在患者治疗方面的专业知识， 参与及其广泛的患者合作伙伴和倡导者网络，以促进社区对 拟议的研究和保留招募的受试者。社区参与协调员将与 招募ME/CFS患者，通过与“We are Curious”合作的在线应用程序定期自我跟踪 平台，他们的症状和治疗，沿着日常活动，饮食干预和环境 暴露，提供支持和指导，以促进整个研究期间的保留。的 临床核心将由露辛达贝特曼博士和苏珊娜D。弗农，既有丰富的经验， 尊敬的ME/CFS临床和研究社区成员。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，并促进采集 强大的和相关的患者参数。具体目的是：1）识别、转诊和招募 新发ME/CFS沿着年龄、种族和性别匹配对照，用于纵向临床跟踪和系列研究 样本采集; 2）进行临床评价，以客观地定义疲劳和日常功能， 劳力性不适、睡眠不振、认知障碍和直立不耐受的共同数据 要素、标准化问卷和设备; 3）监督临床表型的存储和共享 与数据管理和协调中心（DMCC）协调的生物样本数据;以及4） 与We are Curious和MEAction小组合作，开发调查问卷、标签和跟踪系统， 反映ME/CFS患者的症状和经历，并将患者合作伙伴与临床和科学联系起来 通过教育和推广团队。

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.