Core outcomes set for trials in people with coronavirus disease 2019

Allison Tong, Julian H. Elliott, Luciano Cesar Azevedo, Amanda Baumgart, Andrew Bersten, Lilia Cervantes, Derek P. Chew, Yeoungjee Cho, Tess Cooper, Sally Crowe, Ivor S. Douglas, Nicole Evangelidis, Ella Flemyng, Elyssa Hannan, Peter Horby, Martin Howell, Jaehee Lee, Emma Liu, Eduardo Lorca, Deena LynchJohn C. Marshall, Andrea Matus Gonzalez, Anne McKenzie, Karine E. Manera, Charlie McLeod, Sangeeta Mehta, Mervyn Mer, Andrew Conway Morris, Saad Nseir, Pedro Povoa, Mark Reid, Yasser Sakr, Ning Shen, Alan R. Smyth, Tom Snelling, Giovanni F.M. Strippoli, Armando Teixeira-Pinto, Antoni Torres, Tari Turner, Andrea K. Viecelli, Steve Webb, Paula R. Williamson, Laila Woc-Colburn, Junhua Zhang, Jonathan C. Craig

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1622-1635
Number of pages14
JournalCritical Care Medicine
DOIs
Publication statusAccepted/In press - 2020

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