Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery
| Autor: | Karine E. Manera, Armando Teixeira-Pinto, Tess E Cooper, Peter Horby, Saad Nseir, Lilia Cervantes, Andrea Matus Gonzalez, Tom Snelling, Alan R Smyth, Yasser Sakr, Simon A. Carter, Dale M. Needham, Andrew D. Bersten, Paula R Williamson, Giovanni F.M. Strippoli, Luciano Cesar Pontes Azevedo, Antoni Torres, Jonathan C. Craig, Elyssa Hannan, Eduardo Lorca, John C. Marshall, Sally Crowe, Amanda Baumgart, Junhua Zhang, Derek P. Chew, Mervyn Mer, Angela Ju, Sangeeta Mehta, Pedro Póvoa, Ivor S. Douglas, Mark Reid, Deena Lynch, Allison Tong, Anne McKenzie, Ella Flemyng, Steve Webb, Andrea K. Viecelli, A. John Simpson, Julian H Elliott, Martin Howell, Ning Shen, Nicole Evangelidis, Laila Woc-Colburn, Tari Turner, Jaehee Lee, Andrew Conway Morris |
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| Přispěvatelé: | Investigators, COVID-19-Core Outcomes Set |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Research design
medicine.medical_specialty Activities of daily living Delphi Technique Multiple Organ Failure MEDLINE Psychological intervention Clinical Investigations coronavirus medicine.disease_cause Critical Care and Intensive Care Medicine patients sepsis 03 medical and health sciences 0302 clinical medicine Outcome Assessment Health Care Content validity medicine Humans Intensive care medicine Coronavirus COVID-19/epidemiology Clinical Trials as Topic business.industry SARS-CoV-2 Outcome Assessment Health Care/standards Reproducibility of Results COVID-19 030208 emergency & critical care medicine clinical trial Recovery of Function infection Clinical trial critical care Dyspnea 030228 respiratory system Respiratory failure Research Design Practice Guidelines as Topic ComputingMethodologies_DOCUMENTANDTEXTPROCESSING business Respiratory Insufficiency |
| Zdroj: | Critical Care Medicine Tong, A, Baumgart, A, Evangelidis, N, Viecelli, A K, Carter, S A, Azevedo, L C, Cooper, T, Bersten, A, Cervantes, L, Chew, D P, Crowe, S, Douglas, I S, Flemyng, E, Elliott, J H, Hannan, E, Horby, P, Howell, M, Ju, A, Lee, J, Lorca, E, Lynch, D, Manera, K E, Marshall, J C, Gonzalez, A M, McKenzie, A, Mehta, S, Mer, M, Morris, A C, Needham, D M, Nseir, S, Povoa, P, Reid, M, Sakr, Y, Shen, N, Smyth, A R, Simpson, A J, Snelling, T, Strippoli, G F M, Teixeira-Pinto, A, Torres, A, Turner, T, Webb, S, Williamson, P R, Woc-Colburn, L, Zhang, J, Craig, J C & COVID-19-Core Outcomes Set Investigators 2021, ' Core Outcome Measures for Trials in People With Coronavirus Disease 2019 : Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery ', Critical Care Medicine, vol. 49, no. 3, pp. 503-516 . https://doi.org/10.1097/CCM.0000000000004817 |
| ISSN: | 1530-0293 0090-3493 |
| Popis: | Supplemental Digital Content is available in the text. OBJECTIVES: Respiratory failure, multiple organ failure, shortness of breath, recovery, and mortality have been identified as critically important core outcomes by more than 9300 patients, health professionals, and the public from 111 countries in the global coronavirus disease 2019 core outcome set initiative. The aim of this project was to establish the core outcome measures for these domains for trials in coronavirus disease 2019. DESIGN: Three online consensus workshops were convened to establish outcome measures for the four core domains of respiratory failure, multiple organ failure, shortness of breath, and recovery. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Respiratory failure, assessed by the need for respiratory support based on the World Health Organization Clinical Progression Scale, was considered pragmatic, objective, and with broad applicability to various clinical scenarios. The Sequential Organ Failure Assessment was recommended for multiple organ failure, because it was routinely used in trials and clinical care, well validated, and feasible. The Modified Medical Research Council measure for shortness of breath, with minor adaptations (recall period of 24 hr to capture daily fluctuations and inclusion of activities to ensure relevance and to capture the extreme severity of shortness of breath in people with coronavirus disease 2019), was regarded as fit for purpose for this indication. The recovery measure was developed de novo and defined as the absence of symptoms, resumption of usual daily activities, and return to the previous state of health prior to the illness, using a 5-point Likert scale, and was endorsed. CONCLUSIONS: The coronavirus disease 2019 core outcome set recommended core outcome measures have content validity and are considered the most feasible and acceptable among existing measures. Implementation of the core outcome measures in trials in coronavirus disease 2019 will ensure consistency and relevance of the evidence to inform decision-making and care of patients with coronavirus disease 2019. |
| Databáze: | OpenAIRE |
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