VCID Biomarkers Coordinating Center

项目总结/摘要 MarkVCID计划负责执行NIND确定的最高优先事项之一，以减少 脑小血管病（SVD）对认知障碍和痴呆的影响：选择和 验证SVD生物标志物用于VCID研究和试验。MarkVCID 2，当前相位 联合体的结构为位于马萨诸塞州总医院的单一协调中心（CC (MGH)以及由15个美国医疗中心组成的9个表演场地。为了实现MarkVCID 2的目标， 临床验证选定的SVD生物标志物，以便完全准备好试验应用，每个获奖研究中心将 要求在两年内招募至少200名符合MarkVCID 2资格标准的个人，并保留他们 三年内每年进行一次随访。入组人群至少需要包括 足够数量的非洲裔美国人，西班牙裔和高加索人，以确保普遍性， 调查结果通常代表性不足的人群以及跨跨度的足够数量的受试者 年龄和认知障碍可能适合SVD试验。 COVID-19大流行对实现这些雄心勃勃的目标构成了相当大的障碍，特别是对于 在典型的代表性不足的人群中招聘， 短缺的负面影响最大。目前的建议旨在通过以下方式克服这些挑战： 配备MGH CC，作为研究中心招募和保留目标人员的核心资源 不同的学科群体。我们建议在谘询委员会增设两个主要职位： 项目经理和数据和报告专家。项目经理将作为 征聘和留用战略协调员，重点是任职人数不足的群体： 传播和定制最佳做法、征聘材料以及从目标群体中吸取的经验教训， 社区外展活动。数据和报告专家将在 CC用于实时监控并向站点传达可操作的招聘和保留数据， 用于指导战略，分配工作，并避免开发自己的跟踪工具的负担。 通过集中处理确定成功征聘的高要求和耗时的过程， 保留战略和招聘/保留多样性的实时跟踪，这两个职位将采取 大量的非现场人员负担和工作对日益普遍的负面反馈循环， 紧张的工作环境导致现场人员流失。这些将是建立在以下基础上的可持续立场： MGH CC积累的专业知识。通过大量减少重复工作，增加的职位将 允许研究中心将其工作人员重新定向到现场招募和研究访视程序。我们预计 因此，现场工作条件的改善将提高职业满意度，并留住有经验的员工。 研究中心员工以及最终MarkVCID 2的招聘和保留绩效。

Project Summary/Abstract The MarkVCID initiative is responsible for executing one of NIND’s highest identified priorities for reducing the contribution of cerebral small vessel disease (SVD) to cognitive impairment and dementia: selection and validation of SVD biomarkers for use in VCID research and trials. MarkVCID2, the current phase of the consortium, is structured as a single coordinating center (CC) based at Massachusetts General Hospital (MGH) and nine performance sites comprised of 15 US medical centers. To accomplish MarkVCID2’s goal of clinically validating selected SVD biomarkers for full readiness for trial application, each award site will be required to enroll at least 200 individuals meeting MarkVCID2 eligibility criteria over two years and retain them for annual follow-up visits over three years. The enrolled population will be required at a minimum to include adequate numbers of African American, Hispanic, and Caucasian individuals to ensure generalizability of the findings to typically underrepresented populations as well as adequate numbers of subjects across the spans of age and cognitive impairment potentially suitable for SVD trials. The COVID19 pandemic has posed considerable barriers to meeting these ambitious goals, particularly for recruitment in the typically underrepresented populations where obstacles to research participation and staffing shortages have the greatest negative impact. The current proposal seeks to overcome these challenges by equipping the MGH CC to serve as a central core of resources for site recruitment and retention of the targeted diverse subject groups. We propose to establish two key new positions at the CC: a Recruitment and Retention Project Manager and a Data and Reporting Specialist. The Project Manager will serve as the central coordinator of recruitment and retention strategies with focus on underrepresented populations: identifying, disseminating, and customizing best practices, recruitment materials, and lessons learned from targeted community outreach initiatives. The Data and Reporting Specialist will develop and deploy processes at the CC for real-time monitoring and communication to sites of actionable recruitment and retention data that can be used to guide strategy, allocate effort, and avoid the burden of developing their own tracking tools. By centralizing the demanding and time-consuming processes of identifying successful recruitment and retention strategies and real-time tracking of recruitment/retention diversity, these two positions will take substantial burden off site personnel and work against the increasingly prevalent negative feedback loop of stressful work environments causing loss of site personnel. These will be sustainable positions built on the expertise accumulated by the MGH CC. By substantially reducing duplicative work, the added positions will allow sites to redirect their staff to on-the-ground recruitment and study visit procedures. We anticipate that the resultant improvement in site working conditions will improve career satisfaction and retention of experienced site staff and ultimately MarkVCID2’s recruitment and retention performance.