TY - JOUR
T1 - Core outcomes set for trials in people with coronavirus disease 2019
AU - Tong, Allison
AU - Elliott, Julian H.
AU - Azevedo, Luciano Cesar
AU - Baumgart, Amanda
AU - Bersten, Andrew
AU - Cervantes, Lilia
AU - Chew, Derek P.
AU - Cho, Yeoungjee
AU - Cooper, Tess
AU - Crowe, Sally
AU - Douglas, Ivor S.
AU - Evangelidis, Nicole
AU - Flemyng, Ella
AU - Hannan, Elyssa
AU - Horby, Peter
AU - Howell, Martin
AU - Lee, Jaehee
AU - Liu, Emma
AU - Lorca, Eduardo
AU - Lynch, Deena
AU - Marshall, John C.
AU - Gonzalez, Andrea Matus
AU - McKenzie, Anne
AU - Manera, Karine E.
AU - McLeod, Charlie
AU - Mehta, Sangeeta
AU - Mer, Mervyn
AU - Morris, Andrew Conway
AU - Nseir, Saad
AU - Povoa, Pedro
AU - Reid, Mark
AU - Sakr, Yasser
AU - Shen, Ning
AU - Smyth, Alan R.
AU - Snelling, Tom
AU - Strippoli, Giovanni F.M.
AU - Teixeira-Pinto, Armando
AU - Torres, Antoni
AU - Turner, Tari
AU - Viecelli, Andrea K.
AU - Webb, Steve
AU - Williamson, Paula R.
AU - Woc-Colburn, Laila
AU - Zhang, Junhua
AU - Craig, Jonathan C.
AU - COVID-19-Core Outcomes Set (COS) Workshop Investigators
AU - Adhikari, Neill K. J.
AU - Kimberley Ambrose, Kimberley
AU - Anumudu, Samaya
AU - Arabi, Yaseen
AU - Atilano-Carsi, Ximena
AU - Perez, Jairo Barrantes
AU - Bernier-Jean, Amelie
AU - Bozza, Fernando
AU - Carter, Simon
AU - Cebrera, Sebastian
AU - Chan, Elaine
AU - Cook, Deborah
AU - Denholm, Justin
AU - Dominello, Amanda
AU - Douglas, Chris
AU - Echegoyen, Carolina
AU - Ferrari, Paolo
AU - Ghersi, Davina
AU - Gomersall, Charles
AU - Green, Sally
AU - Guha, Chandana
AU - Hanson, Camilla
AU - Harris, Tess
AU - Henry, David
AU - Hill, Sophie
AU - Ho, Yen
AU - Hung, Ivan
AU - Johnson, Tamara
AU - Ju, Angela
AU - Kelly, Ayano
AU - Kerouani, Khaled
AU - Khalid, Rabia
AU - Kilroy, Deb
AU - Kim, Yong Lim
AU - Kohler, Katharina
AU - Laidlaw, Lynn
AU - Levesque, Jonathan
AU - Ling, Lowell
AU - Malins, David
AU - Marks, Guy B.
AU - Maschke, Karen
AU - McGuire, Brian
AU - Natale, Patrizia
AU - Ng, Belinda
AU - O’Hara, Margaret
AU - Openshaw, Loisann
AU - Parker, Tara
AU - Pearson, Sallie-Anne
AU - Petty, Sam
AU - Piva, Simone
AU - Pomiglio, Gabriela
AU - Rawden, Karen
AU - Reddel, Helen
AU - Richards, Tessa
AU - Rodriguez-Martin, Regina
AU - Rowan, Sarah
AU - Saglimbene, Valeria
AU - Saldanha, Ian
AU - Sautenet, Benedicte
AU - Scholes-Robertson, Nicole
AU - Shen, Jenny
AU - Shimizu, Naoki
AU - Staudinger, Thomas
AU - Surber, Alix
AU - Synnot, Anneliese
AU - Turgeon, Alexis F.
AU - Urra, Marcelo
AU - van Biesen, Wim
AU - Vestbo, Jørgen
AU - Wang, Angela
AU - Warzel, Denise
AU - Watson, Jo
AU - Wheeler, David
AU - White, Dave
AU - Wolf, Timo
AU - Wong, Germaine
PY - 2020/11
Y1 - 2020/11
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Coronavirus
KW - Critical care
KW - Infection
KW - Patients
KW - Sepsis
UR - http://www.scopus.com/inward/record.url?scp=85092802957&partnerID=8YFLogxK
U2 - 10.1097/CCM.0000000000004585
DO - 10.1097/CCM.0000000000004585
M3 - Article
C2 - 32804792
AN - SCOPUS:85092802957
SN - 0090-3493
VL - 48
SP - 1622
EP - 1635
JO - Critical Care Medicine
JF - Critical Care Medicine
IS - 11
ER -