A minimal common outcome measure set for COVID-19 clinical research
A minimal common outcome measure set for COVID-19 clinical research
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DOI：
10.1016/s1473-3099(20)30483-7
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发表时间：
2020-08-01
影响因子：
56.3
通讯作者：
Dat, V. Q.
中科院分区：
文献类型：
--
作者：
Marshall, J. C.;Murthy, S.;Dat, V. Q.
临床研究对于有效应对新出现的传染病暴发是必要的。然而，研究工作往往是匆忙组织和使用各种研究工具完成的，结果是跨研究汇集数据是具有挑战性的。为应对迅速演变的COVID-19疫情的需要，世卫组织研究与发展蓝图规划临床特征和管理工作组、国际急性护理试验者论坛和国际严重急性呼吸道和新发感染联盟为COVID-19研究制定了一套最低限度的共同结果衡量标准。这一套包括三个要素：病毒负担测量（定量PCR或周期阈值），患者生存测量（出院时或60天死亡率），以及使用世卫组织临床进展量表通过卫生保健系统测量患者进展，该量表反映了临床疾病过程中的患者轨迹和资源使用情况。我们敦促调查人员将这些关键数据元素纳入正在进行的和未来的研究中，以便在这一直接威胁期间加快数据汇集，并为未来的需求磨练一种工具。
Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.