Core Outcomes Set for Trials in People ...
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Article dans une revue scientifique
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Title :
Core Outcomes Set for Trials in People With Coronavirus Disease 2019
Author(s) :
Tong, Allison [Auteur]
The University of Sydney
Elliott, Julian H. [Auteur]
Monash University [Melbourne]
Azevedo, Luciano Cesar [Auteur]
Baumgart, Amanda [Auteur]
The University of Sydney
Bersten, Andrew [Auteur]
Flinders University [Adelaide, Australia]
Cervantes, Lilia [Auteur]
Chew, Derek P. [Auteur]
Flinders University [Adelaide, Australia]
Cho, Yeoungjee [Auteur]
The University of Queensland [UQ [All campuses : Brisbane, Dutton Park Gatton, Herston, St Lucia and other locations]]
Cooper, Tess [Auteur]
The University of Sydney
Crowe, Sally [Auteur]
Douglas, Ivor S. [Auteur]
University of Colorado [Denver]
Evangelidis, Nicole [Auteur]
The University of Sydney
Flemyng, Ella [Auteur]
Hannan, Elyssa [Auteur]
The University of Sydney
Horby, Peter [Auteur]
University of Oxford
Howell, Martin [Auteur]
The University of Sydney
Lee, Jaehee [Auteur]
Kyungpook National University [Daegu] [KNU]
Liu, Emma [Auteur]
The University of Sydney
Lorca, Eduardo [Auteur]
Universidad de Chile = University of Chile [Santiago] [UCHILE]
Lynch, Deena [Auteur]
Marshall, John C. [Auteur]
University of Toronto
Gonzalez, Andrea Matus [Auteur]
The University of Sydney
McKenzie, Anne [Auteur]
Manera, Karine E. [Auteur]
The University of Sydney
McLeod, Charlie [Auteur]
Mehta, Sangeeta [Auteur]
University of Toronto
Mer, Mervyn [Auteur]
University of the Witwatersrand [Johannesburg] [WITS]
Morris, Andrew Conway [Auteur]
University of Cambridge [UK] [CAM]
Nseir, Saad [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Unité de Glycobiologie Structurale et Fonctionnelle (UGSF) - UMR 8576
Povoa, Pedro [Auteur]
Reid, Mark [Auteur]
Sakr, Yasser [Auteur]
Jena University Hospital [Jena]
Shen, Ning [Auteur]
Smyth, Alan R. [Auteur]
University of Nottingham, UK [UON]
Snelling, Tom [Auteur]
The University of Sydney
Strippoli, Giovanni FM [Auteur]
Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro [UNIBA]
Teixeira-Pinto, Armando [Auteur]
The University of Sydney
Torres, Antoni [Auteur]
Centro de Investigación Biomédica en Red Enfermedades Respiratorias [CIBERES]
Institut d'Investigacions Biomèdiques August Pi i Sunyer [IDIBAPS]
Turner, Tari [Auteur]
Monash University [Melbourne]
Viecelli, Andrea K. [Auteur]
The University of Queensland [UQ [All campuses : Brisbane, Dutton Park Gatton, Herston, St Lucia and other locations]]
Webb, Steve [Auteur]
Monash University [Melbourne]
Williamson, Paula R. [Auteur]
University of Liverpool
Woc-Colburn, Laila [Auteur]
Baylor College of Medecine
Zhang, Junhua [Auteur]
Tianjin University [TJU]
Craig, Jonathan C. [Auteur]
Flinders University [Adelaide, Australia]
The University of Sydney
Elliott, Julian H. [Auteur]
Monash University [Melbourne]
Azevedo, Luciano Cesar [Auteur]
Baumgart, Amanda [Auteur]
The University of Sydney
Bersten, Andrew [Auteur]
Flinders University [Adelaide, Australia]
Cervantes, Lilia [Auteur]
Chew, Derek P. [Auteur]
Flinders University [Adelaide, Australia]
Cho, Yeoungjee [Auteur]
The University of Queensland [UQ [All campuses : Brisbane, Dutton Park Gatton, Herston, St Lucia and other locations]]
Cooper, Tess [Auteur]
The University of Sydney
Crowe, Sally [Auteur]
Douglas, Ivor S. [Auteur]
University of Colorado [Denver]
Evangelidis, Nicole [Auteur]
The University of Sydney
Flemyng, Ella [Auteur]
Hannan, Elyssa [Auteur]
The University of Sydney
Horby, Peter [Auteur]
University of Oxford
Howell, Martin [Auteur]
The University of Sydney
Lee, Jaehee [Auteur]
Kyungpook National University [Daegu] [KNU]
Liu, Emma [Auteur]
The University of Sydney
Lorca, Eduardo [Auteur]
Universidad de Chile = University of Chile [Santiago] [UCHILE]
Lynch, Deena [Auteur]
Marshall, John C. [Auteur]
University of Toronto
Gonzalez, Andrea Matus [Auteur]
The University of Sydney
McKenzie, Anne [Auteur]
Manera, Karine E. [Auteur]
The University of Sydney
McLeod, Charlie [Auteur]
Mehta, Sangeeta [Auteur]
University of Toronto
Mer, Mervyn [Auteur]
University of the Witwatersrand [Johannesburg] [WITS]
Morris, Andrew Conway [Auteur]
University of Cambridge [UK] [CAM]
Nseir, Saad [Auteur]

Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Unité de Glycobiologie Structurale et Fonctionnelle (UGSF) - UMR 8576
Povoa, Pedro [Auteur]
Reid, Mark [Auteur]
Sakr, Yasser [Auteur]
Jena University Hospital [Jena]
Shen, Ning [Auteur]
Smyth, Alan R. [Auteur]
University of Nottingham, UK [UON]
Snelling, Tom [Auteur]
The University of Sydney
Strippoli, Giovanni FM [Auteur]
Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro [UNIBA]
Teixeira-Pinto, Armando [Auteur]
The University of Sydney
Torres, Antoni [Auteur]
Centro de Investigación Biomédica en Red Enfermedades Respiratorias [CIBERES]
Institut d'Investigacions Biomèdiques August Pi i Sunyer [IDIBAPS]
Turner, Tari [Auteur]
Monash University [Melbourne]
Viecelli, Andrea K. [Auteur]
The University of Queensland [UQ [All campuses : Brisbane, Dutton Park Gatton, Herston, St Lucia and other locations]]
Webb, Steve [Auteur]
Monash University [Melbourne]
Williamson, Paula R. [Auteur]
University of Liverpool
Woc-Colburn, Laila [Auteur]
Baylor College of Medecine
Zhang, Junhua [Auteur]
Tianjin University [TJU]
Craig, Jonathan C. [Auteur]
Flinders University [Adelaide, Australia]
Journal title :
Critical Care Medicine
Volume number :
48
Pages :
1622-1635
Publisher :
Ovid Technologies (Wolters Kluwer Health)
Publication date :
2020-11
ISSN :
0090-3493
English keyword(s) :
clinical trial
coronavirus
critical care
infection
patients
sepsis
coronavirus
critical care
infection
patients
sepsis
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
Objectives:
The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient rele-vance, limiting their applicability for clinical decision-making. The aim of this ...
Show more >Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient rele-vance, 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 di-sease 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 sus-pected coronavirus disease 2019, their family members, mem-bers 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 crit-ical 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 out-comes 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). “Dis-tinguishing 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 out-comes to be consistently reported in coronavirus disease 2019 trials.Show less >
Show more >Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient rele-vance, 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 di-sease 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 sus-pected coronavirus disease 2019, their family members, mem-bers 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 crit-ical 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 out-comes 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). “Dis-tinguishing 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 out-comes to be consistently reported in coronavirus disease 2019 trials.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
CNRS
CNRS
Research team(s) :
Glycobiology in fungal Pathogenesis and Clinical Applications
Submission date :
2021-07-15T08:35:08Z
2021-08-23T10:50:31Z
2021-08-23T10:50:31Z
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