. 2020 Sep 14;6(3):00193-2020.

doi: 10.1183/23120541.00193-2020. eCollection 2020 Jul.

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

Alexander G Mathioudakis^{1

2

3}, Fekri Abroug⁴, Alvar Agusti^{5

6}, Per Bakke⁷, Konstantinos Bartziokas⁸, Bianca Beghe⁹, Andras Bikov^{1

2}, Thomas Bradbury¹⁰, Guy Brusselle^{11

12}, Cordula Cadus^{13

14}, Courtney Coleman¹⁵, Marco Contoli¹⁶, Alexandru Corlateanu¹⁷, Olga Corlateanu¹⁸, Gerard Criner¹⁹, Balazs Csoma²⁰, Alexander Emelyanov²¹, Rosa Faner⁵, Gustavo Fernandez Romero¹⁹, Zeineb Hammouda⁴, Peter Horváth²⁰, Arturo Garcia Huerta^{5

22}, Michael Jacobs¹⁹, Christine Jenkins¹⁰, Guy Joos¹², Olga Kharevich²³, Konstantinos Kostikas⁸, Elena Lapteva²³, Zsofia Lazar²⁰, Joerg D Leuppi^{13

14}, Carol Liddle¹⁵, Alejandra López-Giraldo^{5

6}, Vanessa M McDonald^{24

25

26}, Rune Nielsen^{7

27}, Alberto Papi¹⁶, Isabel Saraiva¹⁵, Galina Sergeeva²¹, Agni Sioutkou⁸, Pradeesh Sivapalan^{28

29}, Elizabeth Stovold³⁰, Hao Wang³¹, Fuqiang Wen³¹, Janelle Yorke^{32

33}, Paula R Williamson^{34

35}, Jørgen Vestbo^{1

2}, Jens-Ulrik Jensen^{28

36

37

3}

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

PMID: 32964006
PMCID: PMC7487360
DOI: 10.1183/23120541.00193-2020

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

Alexander G Mathioudakis et al. ERJ Open Res. 2020.

. 2020 Sep 14;6(3):00193-2020.

doi: 10.1183/23120541.00193-2020. eCollection 2020 Jul.

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

PMID: 32964006
PMCID: PMC7487360
DOI: 10.1183/23120541.00193-2020

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.

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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 personal fees from AstraZeneca, grants and personal fees from Menarini, personal fees from Chiesi, grants and personal fees from GSK, and personal fees from Nuvaira, outside the submitted work. Conflict of interest: P. Bakke reports personal fees from GlaxoSmithKline, Chiesi, AstraZeneca and Boehringer Ingelheim 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 being the recipient of an ongoing 3-year top-up scholarship funded by GlaxoSmithKline. Conflict of interest: G. Brusselle reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi and Teva, outside the submitted work. Conflict of interest: C. Cadus reports support from AstraZeneca and Mundipharma, outside the submitted work. Conflict of interest: C. Coleman is an employee of the European Lung Foundation. Conflict of interest: M. Contoli reports grants from Chiesi, personal fees from Chiesi, AstraZeneca, Boehringer Ingelheim, ALK-Abello, Novartis and Zambon, and grants from University of Ferrara, 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. Criner has nothing to disclose. 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 from GSK and Menarini 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 has nothing to disclose. Conflict of interest: G. Joos reports grants and personal fees from AstraZeneca, personal fees from Bayer, grants from Chiesi, personal fees from Eureca vzw, grants and personal fees from GlaxoSmithKline and personal fees from Teva, outside the submitted work; these grants and fees were paid to his institution. Conflict of interest: O. Kharevich has nothing to disclose. Conflict of interest: K. Kostikas reports grants, personal fees and nonfinancial support from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Menarini and Novartis, grants from NuvoAir, and personal fees from Sanofi, outside the submitted work; and was an employee and shareholder of Novartis Pharma AG until 31 October 2018. Conflict of interest: E. Lapteva has nothing to disclose. Conflict of interest: Z. Lazar has nothing to disclose. Conflict of interest: J.D. Leuppi has nothing to disclose. Conflict of interest: C. Liddle 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 AstraZeneca, and personal fees from Menarini, outside the submitted work. Conflict of interest: R. Nielsen reports grants and personal fees from AstraZeneca and Boehringer Ingelheim, grants from Novartis, and grants and personal fees from GlaxoSmithKline, outside the submitted work. Conflict of interest: A. Papi reports grants, personal fees, nonfinancial support and other from GlaxoSmithKline; grants, personal fees and nonfinancial support from AstraZeneca; grants, personal fees, nonfinancial support and other from Boehringer Ingelheim; grants, personal fees, nonfinancial support and other from Chiesi Farmaceutici; grants, personal fees, nonfinancial support and other from TEVA; personal fees, non-financial support and other from Mundipharma; personal fees, non-financial support and other from Zambon; personal fees, non-financial support and other from Novartis; grants, personal fees and non-financial support from Menarini; personal fees, non-financial support and other from Sanofi/Regeneron; personal fees from Roche; grants from Fondazione Maugeri; grants from Fondazione Chiesi; and personal fees from Edmondpharma, all outside the submitted work. 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 from Boehringer Ingelheim 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 has nothing to disclose. Conflict of interest: J. Vestbo reports personal fees from AstraZeneca, grants and personal fees from Boehringer-Ingelheim, personal fees from Chiesi, personal fees from GSK, and personal fees from Novartis, outside the submitted work; and his son is an employee of Chiesi. Conflict of interest: J-U. Jensen has nothing to disclose.

Figures

**FIGURE 1**
Delphi round 2. Respondents will be provided with the score distributions from the first Delphi round, stratified by stakeholder category. Their previous scoring will also be highlighted. (In this example, the respondent's score for this outcome was 8.) Respondents will be asked to reconsider their scoring, based on the available data. They will be under no pressure to change their scores.

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

Affiliations

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

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Abstract

Conflict of interest statement

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