Restarting Human Participant Research at Community-based Observational Studies during the COVID-19 Pandemic.
Restarting Human Participant Research at Community-based Observational Studies during the COVID-19 Pandemic.
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DOI：
10.1161/jaha.120.018832
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发表时间：
2020-11-03
影响因子：
5.4
通讯作者：
Vasan RS
中科院分区：
文献类型：
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作者：
Velagaleti RS;Vasan RS
在2019年冠状病毒病(新冠肺炎)大流行爆发时，就在公共机构和企业关闭之际，进行人类参与研究(HPR)的研究项目也在很大程度上停止了运作。随着疫情在一些地区的部分消退，进行HPR的大学和医疗保健组织正在考虑重新开放。虽然政府当局和医学专业学会目前有指南帮助重新启动卫生服务和恢复临床试验，但没有明确的指南来帮助在基于社区的观察性队列研究中恢复HPR。无限期停止队列研究的观察性研究有许多缺点，其安全恢复是重要和可行的。在这篇叙述性回顾中，我们描述了一条潜在的前进道路，以安全地重启基于社区的观察研究，利用来自各种医学和非专业来源的科学知识和最佳实践。我们重点介绍了当前关于大流行状态评估的建议，以及有助于指导员工和参与者做出安全重启/重合决策以及新冠肺炎筛查和监测的指标。我们综合了关于感染预防和环境安全的当代文献中的见解，形成了一套易于操作的重组HPR的计划。最后，我们建议了观察性研究可能有助于确定大流行特征的方法。
At the onset of the Coronavirus Disease 2019 (COVID‐19) pandemic, just as public institutions and businesses closed, research programs performing human participant research (HPR) also largely ceased operations. With the partial ebbing of the pandemic in some areas, universities and healthcare organizations conducting HPR are considering reopening. Whereas guidelines from governmental authorities and medical specialty societies currently exist to help restarting health services and resuming clinical trials, no clear guidance is available to aid resumption of HPR at community‐based observational cohort studies. Indefinite stoppage of observational research at cohort studies carries many drawbacks and its safe resumption is important and feasible. In this narrative review, we describe a potential path forward for safely reopening community‐based observational studies, drawing on scientific knowledge and best practices from a variety of medical and lay sources. We highlight current recommendations regarding pandemic status assessment and the metrics useful for guiding decisions regarding safe reopening/reclosing and for screening and surveillance of COVID‐19 among employees and participants. We synthesize insights from contemporary literature regarding infection prevention and environmental safety into a set of easy to operationalize plans for restructuring HPR. And lastly, we suggest ways in which observational studies can potentially aid the efforts to characterize the pandemic.