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1. Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol

Author

Alexander G. Mathioudakis, Fekri Abroug, Alvar Agusti, Per Bakke, Konstantinos Bartziokas, Bianca Beghe, Andras Bikov, Thomas Bradbury, Guy Brusselle, Cordula Cadus, Courtney Coleman, Marco Contoli, Alexandru Corlateanu, Olga Corlateanu, Gerard Criner, Balazs Csoma, Alexander Emelyanov, Rosa Faner, Gustavo Fernandez Romero, Zeineb Hammouda, Peter Horváth, Arturo Garcia Huerta, Michael Jacobs, Christine Jenkins, Guy Joos, Olga Kharevich, Konstantinos Kostikas, Elena Lapteva, Zsofia Lazar, Joerg D. Leuppi, Carol Liddle, Alejandra López-Giraldo, Vanessa M. McDonald, Rune Nielsen, Alberto Papi, Isabel Saraiva, Galina Sergeeva, Agni Sioutkou, Pradeesh Sivapalan, Elizabeth Stovold, Hao Wang, Fuqiang Wen, Janelle Yorke, Paula R. Williamson, Jørgen Vestbo, and Jens-Ulrik Jensen

Subjects
Medicine
Abstract

Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations. For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus. Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS.

Published
2020
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2. ERS statement: a core outcome set for clinical trials evaluating the management of COPD exacerbations

Author

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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