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

Alexander G Mathioudakis^{1

2

3}, Fekri Abroug⁴, Alvar Agusti^{5

6}, Sachin Ananth⁷, Per Bakke⁸, Konstantinos Bartziokas⁹, Bianca Beghe¹⁰, Andras Bikov^{1

2}, Thomas Bradbury¹¹, Guy Brusselle^{12

13}, Cordula Cadus^{14

15}, Courtney Coleman¹⁶, Marco Contoli¹⁷, Alexandru Corlateanu¹⁸, Olga Corlateanu¹⁹, Gerard J Criner²⁰, Balazs Csoma²¹, Alexander Emelyanov²², Rosa Faner⁵, Gustavo Fernandez Romero²⁰, Zeineb Hammouda⁴, Peter Horváth²¹, Arturo Huerta Garcia^{5

23}, Michael Jacobs²⁰, Christine Jenkins¹¹, Guy Joos¹³, Olga Kharevich²⁴, Konstantinos Kostikas⁹, Elena Lapteva²⁴, Zsofia Lazar²¹, Joerg D Leuppi^{14

15}, Carol Liddle¹⁶, John Linnell¹⁶, Alejandra López-Giraldo^{5

6}, Vanessa M McDonald^{25

26

27}, Rune Nielsen^{8

28}, Alberto Papi¹⁷, Isabel Saraiva¹⁶, Galina Sergeeva²², Agni Sioutkou⁹, Pradeesh Sivapalan^{29

30}, Elizabeth Stovold³¹, Hao Wang³², Fuqiang Wen³², Janelle Yorke^{33

34}, Paula R Williamson³⁵, Jørgen Vestbo^{36

2}, Jens-Ulrik Jensen^{29

37

3}; DECODE-NET

Affiliations

¹ Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
² The North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
³ A.G. Mathioudakis and J-U. Jensen are the co-chairs of the COS-AECOPD ERS task force.
⁴ Hospital Fattouma Bourguiba, Monastir, Tunisia.
⁵ Respiratory Institute, Hospital Clinic and Catedra de Salud Respiratoria, University of Barcelona, Barcelona, Spain.
⁶ Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), National Spanish Network for Respiratory Research (CIBERES), Barcelona, Spain.
⁷ West Hertfordshire Hospital NHS Trust, Watford, UK.
⁸ Dept of Clinical Science, University of Bergen, Bergen, Norway.
⁹ Respiratory Medicine Dept, University of Ioannina School of Medicine, Ioannina, Greece.
¹⁰ Section of Respiratory Diseases, Dept of Medicine, University of Modena and Reggio Emilia, Modena, Italy.
¹¹ The George Institute for Global Health, University of New South Wales, Sydney, Australia.
¹² Depts of Epidemiology and Respiratory Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.
¹³ Dept of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
¹⁴ University Department of Medicine, Cantonal Hospital Basell and Liestal, Basel, Switzerland.
¹⁵ Faculty of Medicine, University of Basel, Basel, Switzerland.
¹⁶ European Lung Foundation, Sheffield, UK.
¹⁷ Research Center on Asthma and COPD, Dept of Medical Sciences, University of Ferrara, Ferrara, Italy.
¹⁸ Dept of Respiratory Medicine, State University of Medicine and Pharmacy 'Nicolae Testemitanu', Chisinau, Moldova.
¹⁹ Dept of Internal Medicine, State University of Medicine and Pharmacy 'Nicolae Testemitanu', Chisinau, Moldova.
²⁰ Dept of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
²¹ Dept of Pulmonology, Semmelweis University, Budapest, Hungary.
²² Dept of Respiratory Medicine and Allergy, North-Western Medical University St Petersburg, St Petersburg, Russian Federation.
²³ Respiratory Intensive Care Division, Clinica Sagrada Familia, Barcelona, Spain.
²⁴ Dept of Pulmonology and Tuberculosis, Belarusian Medical Academy of Postgraduate Education, Minsk Belarus.
²⁵ Dept of Respiratory and Sleep Medicine, Medical and Interventional Services, John Hunter Hospital, Hunter New England Local Health District, New Lambton Heights, Australia.
²⁶ Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, Australia.
²⁷ School of Nursing and Midwifery, University of Newcastle, Callaghan, Australia.
²⁸ Dept of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway.
²⁹ Section of Respiratory Medicine, Dept of Internal Medicine, Herlev-Gentofte Hospital, Hellerup, Denmark.
³⁰ Dept of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.
³¹ Cochrane Airways Group, Population Health Research Institute, St George's University of London, London, UK.
³² Dept of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.
³³ School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
³⁴ Christie Patient Centred Research, The Christie NHS Foundation Trust, Manchester, UK.
³⁵ MRC/NIHR Trials Methodology Research Partnership, Dept of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.
³⁶ Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK Jorgen.Vestbo@Manchester.ac.uk.
³⁷ Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.

PMID: 34649975
DOI: 10.1183/13993003.02006-2021

Free article

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

Alexander G Mathioudakis et al. Eur Respir J. 2022.

Free article

. 2022 May 5;59(5):2102006.

doi: 10.1183/13993003.02006-2021. Print 2022 May.

Authors

Affiliations

¹ Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
² The North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
³ A.G. Mathioudakis and J-U. Jensen are the co-chairs of the COS-AECOPD ERS task force.
⁴ Hospital Fattouma Bourguiba, Monastir, Tunisia.
⁵ Respiratory Institute, Hospital Clinic and Catedra de Salud Respiratoria, University of Barcelona, Barcelona, Spain.
⁶ Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), National Spanish Network for Respiratory Research (CIBERES), Barcelona, Spain.
⁷ West Hertfordshire Hospital NHS Trust, Watford, UK.
⁸ Dept of Clinical Science, University of Bergen, Bergen, Norway.
⁹ Respiratory Medicine Dept, University of Ioannina School of Medicine, Ioannina, Greece.
¹⁰ Section of Respiratory Diseases, Dept of Medicine, University of Modena and Reggio Emilia, Modena, Italy.
¹¹ The George Institute for Global Health, University of New South Wales, Sydney, Australia.
¹² Depts of Epidemiology and Respiratory Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.
¹³ Dept of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
¹⁴ University Department of Medicine, Cantonal Hospital Basell and Liestal, Basel, Switzerland.
¹⁵ Faculty of Medicine, University of Basel, Basel, Switzerland.
¹⁶ European Lung Foundation, Sheffield, UK.
¹⁷ Research Center on Asthma and COPD, Dept of Medical Sciences, University of Ferrara, Ferrara, Italy.
¹⁸ Dept of Respiratory Medicine, State University of Medicine and Pharmacy 'Nicolae Testemitanu', Chisinau, Moldova.
¹⁹ Dept of Internal Medicine, State University of Medicine and Pharmacy 'Nicolae Testemitanu', Chisinau, Moldova.
²⁰ Dept of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
²¹ Dept of Pulmonology, Semmelweis University, Budapest, Hungary.
²² Dept of Respiratory Medicine and Allergy, North-Western Medical University St Petersburg, St Petersburg, Russian Federation.
²³ Respiratory Intensive Care Division, Clinica Sagrada Familia, Barcelona, Spain.
²⁴ Dept of Pulmonology and Tuberculosis, Belarusian Medical Academy of Postgraduate Education, Minsk Belarus.
²⁵ Dept of Respiratory and Sleep Medicine, Medical and Interventional Services, John Hunter Hospital, Hunter New England Local Health District, New Lambton Heights, Australia.
²⁶ Priority Research Centre for Healthy Lungs, University of Newcastle, Callaghan, Australia.
²⁷ School of Nursing and Midwifery, University of Newcastle, Callaghan, Australia.
²⁸ Dept of Thoracic Medicine, Haukeland University Hospital, Bergen, Norway.
²⁹ Section of Respiratory Medicine, Dept of Internal Medicine, Herlev-Gentofte Hospital, Hellerup, Denmark.
³⁰ Dept of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.
³¹ Cochrane Airways Group, Population Health Research Institute, St George's University of London, London, UK.
³² Dept of Respiratory and Critical Care Medicine, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, China.
³³ School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
³⁴ Christie Patient Centred Research, The Christie NHS Foundation Trust, Manchester, UK.
³⁵ MRC/NIHR Trials Methodology Research Partnership, Dept of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.
³⁶ Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK Jorgen.Vestbo@Manchester.ac.uk.
³⁷ Institute of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.

PMID: 34649975
DOI: 10.1183/13993003.02006-2021

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.

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Conflict of interest statement

Conflict of interest: A.G. Mathioudakis reports grants from Boehringer Ingelheim, outside the submitted work. Conflict of interest: F. Abroug has nothing to disclose. Conflict of interest: A. Agusti reports grants and personal fees for advisory board work and lectures from GSK, Menarini, Chiesi and AZ, outside the submitted work. Conflict of interest: S. Ananth has nothing to disclose. Conflict of interest: P. Bakke reports personal fees for lectures from AstraZeneca, Novartis and GlaxoSmithKline, outside the submitted work. Conflict of interest: K. Bartziokas has nothing to disclose. Conflict of interest: B. Beghe has nothing to disclose. Conflict of interest: A. Bikov has nothing to disclose. Conflict of interest: T. Bradbury reports receiving an academic scholarship funded by GlaxoSmithKline outside the submitted work. Conflict of interest: G. Brusselle reports personal fees for advisory board work and lectures from Astra Zeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi and Teva, outside the submitted work. Conflict of interest: C. Cadus reports personal fees from Mundipharma and AstraZeneca outside the submitted work. Conflict of interest: C. Coleman is an employee of the European Lung Foundation. Conflict of interest: M. Contoli reports board membership, payment for lectures, grants for research and travel expenses reimbursement from Chiesi, AstraZeneca and GlaxoSmithKline, board membership, consultancy, payment for lectures, grants for research and travel expenses reimbursement from Boehringer Ingelheim, board membership, consultancy and travel expenses reimbursement from Alk-Abello, board membership, payment for lectures, travel expenses reimbursement from Novartis and Zambon, grants from University of Ferrara, Italy, outside the submitted work. Conflict of interest: A. Corlateanu has nothing to disclose. Conflict of interest: O. Corlateanu has nothing to disclose. Conflict of interest: G.J. Criner reports grants and personal fees from GlaxoSmithKline, Boehringer Ingelheim, Chiesi, Mereo, AstraZeneca, Pulmonx, Pneumrx, Olympus, Broncus, Lungpacer, Nuvaira, ResMed, Respironics and Patara, personal fees from Verona, BTG, EOLO and NGM, grants from Alung, Fisher Paykel and Galapagos, outside the submitted work. Conflict of interest: B. Csoma has nothing to disclose. Conflict of interest: A. Emelyanov has nothing to disclose. Conflict of interest: R. Faner reports grants and other (advisory board) from GSK, grants from Menarini and AstraZeneca, other (lecture fee) from Chiesi, outside the submitted work. Conflict of interest: G. Fernandez Romero has nothing to disclose. Conflict of interest: Z. Hammouda has nothing to disclose. Conflict of interest: P. Horváth has nothing to disclose. Conflict of interest: A. Huerta Garcia has nothing to disclose. Conflict of interest: M. Jacobs has nothing to disclose. Conflict of interest: C. Jenkins reports personal fees for advisory board work and educational content from AstraZeneca and Boehringer Ingelheim, grants and personal fees for advisory board work and educational content from GlaxoSmithKline, personal fees for consultancy, advisory board work and educational content from Novartis, outside the submitted work. Conflict of interest: G. Joos reports grants, personal fees for lectures and advisory board work, and non-financial support from AstraZeneca and GlaxoSmithKline, grants from Chiesi, personal fees for lectures from Novartis and Lapharcon, outside the submitted work; all fees were paid to his department. Conflict of interest: O. Kharevich has nothing to disclose. Conflict of interest: K. Kostikas was an employee and shareholder of Novartis Pharma AG until 2018; he has received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, GSK, Menarini, Novartis, Sanofi Genzyme and WebMD; his department has received funding and grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir; and he is a member of the GOLD Assembly. Conflict of interest: E. Lapteva has nothing to disclose. Conflict of interest: Z. Lazar has nothing to disclose. Conflict of interest: J.D. Leuppi is supported by grants from the Swiss National Science Foundation (SNF 160072 and 185592) as well as by Swiss Personalised Health Network (SPHN 2018DR108); and has also received unrestricted grants from AstraZeneca AG Switzerland, Boehringer Ingelheim GmbH Switzerland, GSK AG Switzerland, and Novartis AG Switzerland. Conflict of interest: C. Liddle has nothing to disclose. Conflict of interest: J. Linnell has nothing to disclose. Conflict of interest: A. López-Giraldo has nothing to disclose. Conflict of interest: V.M. McDonald reports grants and personal fees from GSK and AZ, personal fees from Novartis, outside the submitted work. Conflict of interest: R. Nielsen reports grants from GlaxoSmithKline Norway and Boehringer Ingelheim, grants and personal fees from AstraZeneca, outside the submitted work. Conflict of interest: A. Papi report grants, personal fees, non-financial support, and other interests at AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Mundipharma and Teva; personal fees and non-financial support from Menarini, Novartis and Zambon; and grants from Sanofi. Conflict of interest: I. Saraiva has nothing to disclose. Conflict of interest: G. Sergeeva has nothing to disclose. Conflict of interest: A. Sioutkou has nothing to disclose. Conflict of interest: P. Sivapalan reports personal fees for lectures from Boehringer Ingelheim, AstraZeneca and GSK, outside the submitted work. Conflict of interest: E. Stovold has nothing to disclose. Conflict of interest: H. Wang has nothing to disclose. Conflict of interest: F. Wen has nothing to disclose. Conflict of interest: J. Yorke has nothing to disclose. Conflict of interest: P.R. Williamson reports personal fees from European Respiratory Society, during the conduct of the study. Conflict of interest: J. Vestbo reports personal fees for consultancy and lectures from AstraZeneca, Chiesi and Novartis, grants and personal fees for consultancy and lectures from Boehringer Ingelheim, personal fees for consultancy from GSK, outside the submitted work; and the author's son works for Chiesi. Conflict of interest: J-U. Jensen has nothing to disclose.

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical