Accéder directement au contenu Accéder directement à la navigation
Article dans une revue

Core Outcomes Set for Trials in People With Coronavirus Disease 2019

Allison Tong 1 Julian H. Elliott 2 Luciano Cesar Azevedo Amanda Baumgart 1 Andrew Bersten 3 Lilia Cervantes Derek P. Chew 3 yeoungjee Cho 4 Tess Cooper 1 Sally Crowe Ivor S. Douglas 5 Nicole Evangelidis 1 Ella Flemyng Elyssa Hannan 1 Peter Horby 6 Martin Howell 1 Jaehee Lee 7 Emma Liu 1 Eduardo Lorca 8 Deena Lynch John C. Marshall 9 Andrea Matus Gonzalez 1 Anne Mckenzie Karine E. Manera 1 Charlie Mcleod Sangeeta Mehta 9 Mervyn Mer 10 Andrew Conway Morris 11 Saad Nseir 12, 13 Pedro Povoa Mark Reid yasser Sakr 14 Ning Shen Alan R. Smyth 15 Tom Snelling 1 Giovanni Fm Strippoli 16 Armando Teixeira-Pinto 1 Antoni Torres 17, 18 Tari Turner 2 Andrea K. Viecelli 4 Steve Webb 2 Paula R. Williamson 19 Laila Woc-Colburn 20 Junhua Zhang 21 Jonathan C. Craig 3 
Abstract : 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.
Liste complète des métadonnées
Contributeur : LillOA Université de Lille Connectez-vous pour contacter le contributeur
Soumis le : lundi 23 août 2021 - 12:51:28
Dernière modification le : mardi 3 mai 2022 - 15:14:05
Archivage à long terme le : : mercredi 24 novembre 2021 - 18:27:36


Publication financée par une institution


Distributed under a Creative Commons Paternité 4.0 International License




Allison Tong, Julian H. Elliott, Luciano Cesar Azevedo, Amanda Baumgart, Andrew Bersten, et al.. Core Outcomes Set for Trials in People With Coronavirus Disease 2019. Critical Care Medicine, Lippincott, Williams & Wilkins, 2020, 48 (11), pp.1622-1635. ⟨10.1097/ccm.0000000000004585⟩. ⟨hal-03324175⟩



Consultations de la notice


Téléchargements de fichiers