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Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)

Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)
Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)

BACKGROUND: Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) working group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies.

METHODS: COMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult, and paediatric clinicians, pharmaceutical representatives and health regulators from across Europe. Evidence included a systematic review of development, validity, and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients' and carers' views about outcome measures. It was discussed using a modified GRADE Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria.

RESULTS: Both adult and paediatric COM sets include forced expiratory volume in 1 s (FEV1) as z scores, annual frequency of severe exacerbations and maintenance oral corticosteroid use. Additionally, the paediatric COM set includes the Paediatric Asthma Quality of Life Questionnaire, and Asthma Control Test (ACT) or Childhood-ACT while the adult COM includes the Severe Asthma Questionnaire and the Asthma Control Questionnaire-6 (symptoms and rescue medication use reported separately).

CONCLUSIONS: This patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.

0903-1936
Khaleva, Ekaterina
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Rattu, Anna
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Brightling, Chris
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Bush, Andrew
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Bossios, Apostolos
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Bourdin, Arnaud
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Chung, Kian Fan
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Chaudhuri, Rekha
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Coleman, Courtney
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Dahlén, Sven-Erik
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Deschildre, Antoine
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Fleming, Louise
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Fowler, Stephen J
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Melén, Erik
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Pilette, Charles
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Porsbjerg, Celeste
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Pike, Katharine C
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Rusconi, Franca
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Williams, Clare
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Ahrens, Birgit
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Alter, Peter
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Anckers, Freja
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van den Berge, Maarten
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Blumchen, Katharina
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Brusselle, Guy
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Clarke, Graham W
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Cunoosamy, Danen
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Dahlén, Barbro
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Dixey, Piers
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Exley, Andrew
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Frey, Urs
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Gaillard, Erol A
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Giovannini-Chami, Lisa
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Grigg, Jonathan
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Hartenstein, Diana
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Heaney, Liam G
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Karadag, Bülent
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Kaul, Susanne
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Kull, Inger
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Licari, Amelia
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Maitland-van der Zee, Anke H
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Mahler, Vera
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Roberts, Graham
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COMSA working group in the 3TR consortium
Khaleva, Ekaterina
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Rattu, Anna
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Brightling, Chris
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Bush, Andrew
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Bossios, Apostolos
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Bourdin, Arnaud
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Chung, Kian Fan
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Chaudhuri, Rekha
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Coleman, Courtney
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Dahlén, Sven-Erik
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Djukanovic, Ratko
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Deschildre, Antoine
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Fleming, Louise
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Hamelmann, Eckard
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Hashimoto, Simone
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Hedlin, Gunilla
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Melén, Erik
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Murray, Clare S
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Pilette, Charles
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Porsbjerg, Celeste
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Pike, Katharine C
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Rusconi, Franca
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Williams, Clare
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Ahrens, Birgit
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Alter, Peter
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Anckers, Freja
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van den Berge, Maarten
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Blumchen, Katharina
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Brusselle, Guy
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Clarke, Graham W
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Cunoosamy, Danen
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Dahlén, Barbro
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Dixey, Piers
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Frey, Urs
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Gaillard, Erol A
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Giovannini-Chami, Lisa
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Grigg, Jonathan
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Hartenstein, Diana
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Heaney, Liam G
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Karadag, Bülent
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Kaul, Susanne
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Kull, Inger
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Licari, Amelia
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Maitland-van der Zee, Anke H
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Mahler, Vera
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Roberts, Graham
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Khaleva, Ekaterina, Rattu, Anna and Brightling, Chris , COMSA working group in the 3TR consortium (2022) Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA). The European respiratory journal, 61, [2200606]. (doi:10.1183/13993003.00606-2022).

Record type: Review

Abstract

BACKGROUND: Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) working group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies.

METHODS: COMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult, and paediatric clinicians, pharmaceutical representatives and health regulators from across Europe. Evidence included a systematic review of development, validity, and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients' and carers' views about outcome measures. It was discussed using a modified GRADE Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria.

RESULTS: Both adult and paediatric COM sets include forced expiratory volume in 1 s (FEV1) as z scores, annual frequency of severe exacerbations and maintenance oral corticosteroid use. Additionally, the paediatric COM set includes the Paediatric Asthma Quality of Life Questionnaire, and Asthma Control Test (ACT) or Childhood-ACT while the adult COM includes the Severe Asthma Questionnaire and the Asthma Control Questionnaire-6 (symptoms and rescue medication use reported separately).

CONCLUSIONS: This patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.

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e-pub ahead of print date: 13 October 2022
Additional Information: Copyright ©The authors 2022. For reproduction rights and permissions contact permissions@ersnet.org.

Identifiers

Local EPrints ID: 477345
URI: http://eprints.soton.ac.uk/id/eprint/477345
DOI: doi:10.1183/13993003.00606-2022
ISSN: 0903-1936
PURE UUID: d33f5b2d-186a-4df4-8c3d-3218fab63fd0
ORCID for Ekaterina Khaleva: ORCID iD orcid.org/0000-0002-2220-7745
ORCID for Anna Rattu: ORCID iD orcid.org/0000-0002-7497-9552
ORCID for Ratko Djukanovic: ORCID iD orcid.org/0000-0001-6039-5612
ORCID for Graham Roberts: ORCID iD orcid.org/0000-0003-2252-1248

Catalogue record

Date deposited: 05 Jun 2023 16:40
Last modified: 12 Sep 2024 02:00

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Contributors

Author: Ekaterina Khaleva ORCID iD
Author: Anna Rattu ORCID iD
Author: Chris Brightling
Author: Andrew Bush
Author: Apostolos Bossios
Author: Arnaud Bourdin
Author: Kian Fan Chung
Author: Rekha Chaudhuri
Author: Courtney Coleman
Author: Sven-Erik Dahlén
Author: Ratko Djukanovic ORCID iD
Author: Antoine Deschildre
Author: Louise Fleming
Author: Stephen J Fowler
Author: Atul Gupta
Author: Eckard Hamelmann
Author: Simone Hashimoto
Author: Gunilla Hedlin
Author: Gerard H Koppelman
Author: Erik Melén
Author: Clare S Murray
Author: Charles Pilette
Author: Celeste Porsbjerg
Author: Katharine C Pike
Author: Franca Rusconi
Author: Clare Williams
Author: Birgit Ahrens
Author: Peter Alter
Author: Freja Anckers
Author: Maarten van den Berge
Author: Katharina Blumchen
Author: Guy Brusselle
Author: Graham W Clarke
Author: Danen Cunoosamy
Author: Barbro Dahlén
Author: Piers Dixey
Author: Andrew Exley
Author: Urs Frey
Author: Erol A Gaillard
Author: Lisa Giovannini-Chami
Author: Jonathan Grigg
Author: Diana Hartenstein
Author: Liam G Heaney
Author: Bülent Karadag
Author: Susanne Kaul
Author: Inger Kull
Author: Amelia Licari
Author: Anke H Maitland-van der Zee
Author: Vera Mahler
Author: Graham Roberts ORCID iD
Corporate Author: COMSA working group in the 3TR consortium

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