Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia.
Crit Care Med. 2020 Nov;48(11):1622-1635. doi: 10.1097/CCM.0000000000004585.
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.
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.
International.
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).
None.
None.
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.
Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials.
在 2019 年冠状病毒病（COVID-19）临床试验中报告的结果存在极大的异质性，且对患者的相关性不确定，这限制了它们在临床决策中的适用性。本研讨会的目的是为疑似或确诊 COVID-19 患者的临床试验制定一个核心结局集。
召开了四次国际在线多利益攸关方共识研讨会，以讨论基于涉及来自 111 个国家的 9289 名受访者的调查所提出的疑似或确诊 COVID-19 患者临床试验的核心结局。对这些记录进行了主题分析。研讨会的建议被用来敲定核心结局集。
国际。
年龄在 18 岁及以上的确诊或疑似 COVID-19 患者、其家属、公众成员和卫生专业人员（包括临床医生、政策制定者、监管者、资助者、研究人员）。
无。
无。
确定了六个主题。“应对严重急性卫生危机”反映了拯救生命和预防危及生命的并发症的直接重点，这是将死亡率、呼吸衰竭和多器官衰竭作为高度优先事项的基础。“捕捉不同的护理环境”强调了减轻医院负担和承认社区环境中的结果的必要性。“涵盖疾病的全过程和严重程度”旨在解决长期影响和疾病的全貌（例如呼吸急促和康复）。“区分重叠、相关性和共线性”意味着认识到呼吸急促等症状具有独特的价值，并尽量减少重叠（例如，肺功能和肺炎是向呼吸衰竭发展的连续体）。“识别不良事件”是指新出现的干预措施的潜在危害。“意识到家庭和心理社会福利”反映了 COVID-19 的普遍影响。
死亡率、呼吸衰竭、多器官衰竭、呼吸急促和康复是 COVID-19 临床试验中需要一致报告的至关重要的结局。
