Objectives:
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.
Design:
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.
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, and researchers).
Interventions:
None.
Measurements:
None.
Main Results:
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.
Conclusions:
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.
Nicole Evangelidis, MPhil,1,,2 Allison Tong, PhD,corresponding author1,,2 Martin Howell, PhD,1,,2 Armando Teixeira-Pinto, PhD,1,,2 Julian H Elliott, MD, PhD,3 Luciano Cesar Azevedo, PhD,4 Andrew Bersten, MD,5 Lilia Cervantes, MD,6 Derek P Chew, PhD,5 Sally Crowe,7 Ivor S Douglas, MD,8 Ella Flemyng, MSc,9 Peter Horby, PhD,10 Jaehee Lee, MD,11 Eduardo Lorca, MD,12 Deena Lynch, BBus,13 John C. Marshall, MD,14 Anne McKenzie,15 Sangeeta Mehta, MD,16 Mervyn Mer, PhD,17 Andrew Conway Morris, PhD,18 Saad Nseir, PhD,19 Pedro Povoa, PhD,20 Mark Reid, MD,6 Yasser Sakr, PhD,21 Ning Shen, PhD,22 Alan R. Smyth, MD,23 Tom Snelling, PhD,1 Giovanni F. M. Strippoli, PhD,1,,24 Antoni Torres, PhD,25 Tari Turner, PhD,3 Steve Webb, PhD,3 Paula R. Williamson, PhD,26 Laila Woc-Colburn, MD,27 Junhua Zhang, PhD,28 Amanda Baumgart, BPsych (Hons),1,,2 Sebastian Cabrera, PhD,12 Yeoungjee Cho, PhD,29 Tess Cooper, MPH,1,,2 Chandana Guha, MA,1,,2 Emma Liu, , MPhil,1,,2 Andrea Matus Gonzalez, BNutrSc,1,,2 Charlie McLeod, MD,30 Patrizia Natale, MPH,1,,24 Valeria Saglimbene, PhD,1,,24 Andrea K. Viecelli, PhD,29 and Jonathan C. Craig, PhD5, for the COVID-19-Core Outcomes Set (COS) Survey Investigators
1Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
2Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.
3Cochrane Australia, School of Public Health and Preventive Medicine, Monash University, Melbourne, 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.
7Crowe Associates Ltd, Oxon, United Kingdom.
8Department of Medicine, Pulmonary Sciences and Critical Care, Denver Health and University of Colorado Anschutz, School of Medicine, Denver, CO.
9Editorial and Methods Department, Cochrane, London, United Kingdom.
10Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
11Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.
12Department of Internal Medicine, Faculty of Medicine, University of Chile, Santiago, Chile.
13Jonze Society, Brisbane, Australia.
14Department of Surgery, University of Toronto, Toronto, ON, Canada.
15Telethon Kids Institute, Perth, Australia.
16Department of Medicine and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
17Divisions of Critical Care and Pulmonology, Department of Medicine, Charlotte Maxeke Johannesburg Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
18Department of Medicine, University of Cambridge, Cambridge, United Kingdom.
19Critical Care Centre, CHU Lille, and Lille University, F-59000 Lille, France.
20Nova Medical School, CHRC, New University of Lisbon, Polyvalent Intensive Care Unit, Sao Francisco Xavier Hospital, CHLO, Lisbon, Portugal. Center for Clinical Epidemiology and Research Unit of Clinical Epidemiology, OUH Odense University Hospital, Denmark.
21Department of Anesthesiology and Intensive Care, Jena University Hospital, Jena, Germany.
22Department of Respiratory Medicine, Peking University Third Hospital, Beijing, China.
23Evidence Based Child Health Group, University of Nottingham, Nottingham, United Kingdom.
24Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
25Department of Pulmonology Hospital Clinic. University of Barcelona, CIBERES, IDIBAPS, ICREA, Barcelona, Spain.
26Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
27Section of Infectious Diseases Department of Medicine, National School of Tropical Medicine Baylor College of Medicine, Houston, TX.
28Evidence-based Medicine center, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
29Faculty of Medicine, University of Queensland, Brisbane, Australia.
30Department of Infectious Diseases, Perth Children’s Hospital, Perth, Australia.
Disease Category: Infectious disease
Disease Name: Coronavirus
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- Patient perspectives
- Prioritising
- Delphi process