Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.
Crit Care Med. 2020 Nov;48(11):1612-1621. doi: 10.1097/CCM.0000000000004584.
There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials.
In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically.
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, and researchers).
None.
None.
In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median ≥ 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes.
Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals.
已有超过 4000 项针对 2019 年冠状病毒病患者的试验，但由于结局的变异性以及缺乏以患者为中心的结局，这些试验可能对决策的影响降低。本研究的目的是制定一份基于共识的、优先考虑的 2019 年冠状病毒病试验结局清单。
通过一项在线调查，用英语、中文、意大利语、葡萄牙语和西班牙语进行，2019 年冠状病毒病患者、其家属、卫生专业人员和公众使用 9 分 Likert 量表（7-9 分为关键重要性）对结局的重要性进行评分，并完成最佳最差量表以估计相对重要性。对参与者的评论进行了主题分析。
国际。
18 岁及以上确诊或疑似 2019 年冠状病毒病患者、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、资助者和研究人员）。
无。
无。
共有来自 111 个国家的 9289 名参与者（776 名 2019 年冠状病毒病患者或家属、4882 名卫生专业人员和 3631 名公众）完成了这项调查。所有三组人群最优先考虑的四个结局是：死亡率、呼吸衰竭、肺炎和器官衰竭。肺功能、肺纤维化、败血症、呼吸急促和血氧水平是所有三组人群中前 10 个结局的常见结局（平均>7.5 分，中位数≥8 分，>70%的应答者认为结局至关重要）。患者/家属比卫生专业人员更重视疲劳、焦虑、胸痛、肌肉疼痛、胃肠道问题和心血管疾病。有四个主题支持优先级排序：对危及生命、使人衰弱和永久性后果的恐惧；解决知识空白；为准备和规划提供便利；以及可耐受或不常见的结局。
危及生命的呼吸系统和其他器官结局始终被所有利益攸关方群体高度优先考虑。与卫生专业人员相比，患者/家属更重视许多患者报告的结局。
