Core Outcomes Set for Trials in People With Coronavirus Disease 2019
Core Outcomes Set for Trials in People With Coronavirus Disease 2019
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DOI：
10.1097/ccm.0000000000004585
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发表时间：
2020-11-01
影响因子：
8.8
通讯作者：
Craig, Jonathan C.
中科院分区：
文献类型：
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作者：
Tong, Allison;Elliott, Julian H.;Craig, Jonathan C.
目的：2019年冠状病毒病试验中报告的结果极其异质，患者相关性不确定，限制了其对临床决策的适用性。本次研讨会的目的是为2019年疑似或确诊的冠状病毒病患者的试验建立核心结果集。设计图：召开了四次国际在线多方利益相关者共识研讨会，讨论2019年疑似或确诊冠状病毒病患者试验的拟议核心结果，该结果来自一项涉及111个国家9，289名受访者的调查。这些成绩单是按主题分析的。讲习班的建议被用于最后确定核心成果集。背景：国际。主题：18岁及以上确诊或疑似2019年冠状病毒病的成年人，他们的家人，公众和卫生专业人员（包括临床医生，政策制定者，监管机构，资助者，研究人员）。干预措施：无。测量：无。主要结果：确定了六个主题。“应对严重和急性健康危机”反映了当前的重点是拯救生命和预防危及生命的并发症，这是死亡率、呼吸衰竭和多器官衰竭高度优先的基础。“抓住不同的护理环境”强调需要尽量减少医院的负担，并承认社区环境的成果。“涵盖疾病的整个轨迹和严重程度”是指处理长期影响和疾病的全部范围（例如呼吸短促和恢复）。“区分重叠、相关性和共线性”意味着认识到呼吸短促等症状具有不同的价值，并最大限度地减少重叠（例如，肺功能和肺炎处于呼吸衰竭的连续体上）。“识别不良事件”是指新的和不断发展的干预措施的潜在危害。“认识家庭和心理健康”反映了2019年冠状病毒病的广泛影响。结论：死亡率、呼吸衰竭、多器官衰竭、呼吸短促和恢复是2019年冠状病毒病试验中一致报告的至关重要的结局。
Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019. Design: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set. Setting: International. Subjects: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers). Interventions: None. Measurements: None. Main Results: Six themes were identified. "Responding to the critical and acute health crisis" reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. "Capturing different settings of care" highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. "Encompassing the full trajectory and severity of disease" was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). "Distinguishing overlap, correlation and collinearity" meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). "Recognizing adverse events" refers to the potential harms of new and evolving interventions. "Being cognizant of family and psychosocial wellbeing" reflected the pervasive impacts of coronavirus disease 2019. Conclusions: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials.