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.
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).
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.
To establish a core outcome set for research in patients with confirmed or suspected 2019-nCoV.Contributors
Allison Tong 1 2, Julian H Elliott 3, Luciano Cesar Azevedo 4, Amanda Baumgart 1 2, Andrew Bersten 5, Lilia Cervantes 6, Derek P Chew 5, Yeoungjee Cho 7, Tess Cooper 1 2, Sally Crowe 8, Ivor S Douglas 9, Nicole Evangelidis 1 2, Ella Flemyng 10, Elyssa Hannan 1 2, Peter Horby 11, Martin Howell 1 2, Jaehee Lee 12, Emma Liu 1 2, Eduardo Lorca 13, Deena Lynch 14, John C Marshall 15, Andrea Matus Gonzalez 1 2, Anne McKenzie 16, Karine E Manera 1 2, Charlie McLeod 17, Sangeeta Mehta 18, Mervyn Mer 19, Andrew Conway Morris 20, Saad Nseir 21, Pedro Povoa 22 23, Mark Reid 6, Yasser Sakr 24, Ning Shen 25, Alan R Smyth 26, Tom Snelling 1, Giovanni Fm Strippoli 1 27, Armando Teixeira-Pinto 1 2, Antoni Torres 28, Tari Turner 3, Andrea K Viecelli 7, Steve Webb 3, Paula R Williamson 29, Laila Woc-Colburn 30, Junhua Zhang 31, Jonathan C Craig 5, COVID-19-Core Outcomes Set (COS) Workshop Investigators
1Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
2Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia.
3Cochrane Australia, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
4Department of Critical Care Medicine, Hospital Sirio-Libanes, São Paulo, Brazil.
5College of Medicine and Public Health, Flinders University, Adelaide, Australia.
6Department of Medicine, Denver Health, Denver, CO.
7Faculty of Medicine, University of Queensland at Princess Alexandra Hospital, Brisbane, Qld, Australia.
8Crowe Associates Ltd, Oxon, United Kingdom.
9Department of Medicine, Pulmonary Sciences and Critical Care, Denver Health and University of Colorado Anschutz, School of Medicine Denver, Aurora, CO.
10Department of Editorial and Methods, Cochrane, London, United Kingdom.
11Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
12Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.
13Department of Internal Medicine, Faculty of Medicine, University of Chile, Santiago, Chile.
14Jonze Society, Brisbane, Qld, Australia.
15Department of Surgery, University of Toronto, Toronto, ON, Canada.
16Telethon Kids Institute, Perth, WA, Australia.
17Department of Infectious Diseases, Perth Children's Hospital, Perth, WA, Australia.
18Department of Medicine and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
19Department of Medicine, Divisions of Critical Care and Pulmonology, Charlotte Maxeke Johannesburg Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
20Department of Medicine, University of Cambridge, Cambridge, United Kingdom.
21Critical Care Centre, CHU Lille, and Lille University, F-59000 Lille, France.
22Nova Medical School, CHRC, New University of Lisbon, Polyvalent Intensive Care Unit, Sao Francisco Xavier Hospital, CHLO, Lisbon, Portugal.
23Center for Clinical Epidemiology and Research Unit of Clinical Epidemiology, OUH Odense University Hospital, Odense, Denmark.
24Department of Anesthesiology and Intensive Care, Jena University Hospital, Jena, Germany.
25Department of Respiratory Medicine, Peking University Third Hospital, Beijing, China.
26Evidence Based Child Health Group, University of Nottingham, Nottingham, United Kingdom.
27Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
28Department of Pulmonology Hospital Clinic. University of Barcelona, CIBERES, IDIBAPS, Barcelona, Spain.
29Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
30Section of Infectious Diseases Department of Medicine, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX.
31Evidence-based Medicine center, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
- COS for clinical trials or clinical research
- Consensus conference
- Delphi process
- Literature review
Systematic review of outcomes reported in registered and published trials
International two-round Delphi survey
Three consecutive online consensus workshops
Stakeholder groups - ALL – its open to all given the nature of the condition