1. ERS statement: a core outcome set for clinical trials evaluating the management of COPD exacerbations
- Author
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Janelle Yorke, Cordula Cadus, John Linnell, Peter Horvath, Zsofia Lazar, Rosa Faner, Michael R. Jacobs, Fekri Abroug, Alexander G. Mathioudakis, Vanessa M. McDonald, Marco Contoli, Sachin Ananth, Galina Sergeeva, Pradeesh Sivapalan, Guy Brusselle, Alberto Papi, Hao Wang, Konstantinos Kostikas, Bianca Beghe, Agni Sioutkou, Gerard J. Criner, Jens-Ulrik Stæhr Jensen, Thomas Bradbury, Alejandra López-Giraldo, Andras Bikov, Joerg D. Leuppi, Courtney Coleman, Elizabeth Stovold, Carol Liddle, Alexander Emelyanov, Rune Nielsen, Guy Joos, Jørgen Vestbo, Christine Jenkins, Paula R Williamson, Gustavo Fernandez Romero, Alvar Agusti, Olga Kharevich, Isabel Saraiva, Fuqiang Wen, Balázs Csoma, Elena Lapteva, Arturo Humberto Huerta Garcia, Zeineb Hammouda, Olga Corlateanu, Decode-Net, Konstantinos Bartziokas, Alexandru Corlateanu, Per Bakke, and Epidemiology
- Subjects
Pulmonary and Respiratory Medicine ,Chronic Obstructive ,medicine.medical_specialty ,Activities of daily living ,Delphi Technique ,MEDLINE ,Delphi method ,Outcome (game theory) ,Pulmonary Disease ,Pulmonary Disease, Chronic Obstructive ,Quality of life (healthcare) ,Activities of Daily Living ,Humans ,Research Design ,Treatment Outcome ,Quality of Life ,Medicine ,Intensive care medicine ,COPD ,business.industry ,medicine.disease ,Clinical trial ,Systematic review ,business - Abstract
Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritised for inclusion in the core outcome set through a two-round Delphi survey completed by 1063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in five continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to 1) finalise the core outcome set and 2) prioritise a single measurement instrument to be used for evaluating each of the prioritised outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for at all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, the need for a higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimise some of the selected measurement instruments. The panel did not consider the prioritised set of outcomes and associated measurement instruments to be burdensome for patients and health professionals to use.
- Published
- 2021
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