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International Survey to Establish Prioritized Outcomes for Trials in People With Coronavirus Disease 2019.
Evangelidis, Nicole; Tong, Allison; Howell, Martin; Teixeira-Pinto, Armando; Elliott, Julian H; Azevedo, Luciano Cesar; Bersten, Andrew; Cervantes, Lilia; Chew, Derek P; Crowe, Sally; Douglas, Ivor S; Flemyng, Ella; Horby, Peter; Lee, Jaehee; Lorca, Eduardo; Lynch, Deena; Marshall, John C; McKenzie, Anne; Mehta, Sangeeta; Mer, Mervyn; Morris, Andrew Conway; Nseir, Saad; Povoa, Pedro; Reid, Mark; Sakr, Yasser; Shen, Ning; Smyth, Alan R; Snelling, Tom; Strippoli, Giovanni F M; Torres, Antoni; Turner, Tari; Webb, Steve; Williamson, Paula R; Woc-Colburn, Laila; Zhang, Junhua; Baumgart, Amanda; Cabrera, Sebastian; Cho, Yeoungjee; Cooper, Tess; Guha, Chandana; Liu, Emma; Gonzalez, Andrea Matus; McLeod, Charlie; Natale, Patrizia; Saglimbene, Valeria; Viecelli, Andrea K; Craig, Jonathan C.
  • Evangelidis N; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  • Tong A; Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.
  • Howell M; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  • Teixeira-Pinto A; Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.
  • Elliott JH; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  • Azevedo LC; Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.
  • Bersten A; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  • Cervantes L; Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.
  • Chew DP; Cochrane Australia, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
  • Crowe S; Department of Critical Care Medicine, Hospital Sirio-Libanes, São Paulo, Brazil.
  • Douglas IS; College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
  • Flemyng E; Department of Medicine, Denver Health, Denver, CO.
  • Horby P; College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
  • Lee J; Crowe Associates Ltd, Oxon, United Kingdom.
  • Lorca E; Department of Medicine, Pulmonary Sciences and Critical Care, Denver Health and University of Colorado Anschutz, School of Medicine, Denver, CO.
  • Lynch D; Editorial and Methods Department, Cochrane, London, United Kingdom.
  • Marshall JC; Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
  • McKenzie A; Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea.
  • Mehta S; Department of Internal Medicine, Faculty of Medicine, University of Chile, Santiago, Chile.
  • Mer M; Jonze Society, Brisbane, Australia.
  • Morris AC; Department of Surgery, University of Toronto, Toronto, ON, Canada.
  • Nseir S; Telethon Kids Institute, Perth, WA, Australia.
  • Povoa P; Department of Medicine and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
  • Reid M; Divisions 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.
  • Sakr Y; Department of Medicine, University of Cambridge, Cambridge, United Kingdom.
  • Shen N; Critical Care Centre, CHU Lille, and Lille University, F-59000 Lille, France.
  • Smyth AR; Nova 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.
  • Snelling T; Department of Medicine, Denver Health, Denver, CO.
  • Strippoli GFM; Department of Anesthesiology and Intensive Care, Jena University Hospital, Jena, Germany.
  • Torres A; Department of Respiratory Medicine, Peking University Third Hospital, Beijing, China.
  • Turner T; Evidence Based Child Health Group, University of Nottingham, Nottingham, United Kingdom.
  • Webb S; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  • Williamson PR; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  • Woc-Colburn L; Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
  • Zhang J; Department of Pulmonology Hospital Clinic. University of Barcelona, CIBERES, IDIBAPS, ICREA, Barcelona, Spain.
  • Baumgart A; Cochrane Australia, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
  • Cabrera S; Cochrane Australia, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
  • Cho Y; Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
  • Cooper T; Section of Infectious Diseases Department of Medicine, National School of Tropical Medicine Baylor College of Medicine, Houston, TX.
  • Guha C; Evidence-based Medicine center, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
  • Liu E; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  • Gonzalez AM; Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.
  • McLeod C; Department of Internal Medicine, Faculty of Medicine, University of Chile, Santiago, Chile.
  • Natale P; Faculty of Medicine, University of Queensland, Brisbane, Old, Australia.
  • Saglimbene V; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  • Viecelli AK; Centre for Kidney Research, The Children's Hospital at Westmead, NSW, Australia.
  • Craig JC; Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
Crit Care Med ; 48(11): 1612-1621, 2020 11.
Article in English | MEDLINE | ID: covidwho-720987
ABSTRACT

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Randomized Controlled Trials as Topic / Coronavirus Infections / Betacoronavirus / Health Priorities Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: Crit Care Med Year: 2020 Document Type: Article Affiliation country: CCM.0000000000004584

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Randomized Controlled Trials as Topic / Coronavirus Infections / Betacoronavirus / Health Priorities Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: Crit Care Med Year: 2020 Document Type: Article Affiliation country: CCM.0000000000004584