TY - JOUR
T1 - Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)
AU - COMSA working group in the 3TR consortium
AU - Khaleva, Ekaterina
AU - Rattu, Anna
AU - Brightling, Chris
AU - Bush, Andrew
AU - Bossios, Apostolos
AU - Bourdin, Arnaud
AU - Chung, Kian Fan
AU - Chaudhuri, Rekha
AU - Coleman, Courtney
AU - Dahlén, Sven-Erik
AU - Djukanovic, Ratko
AU - Deschildre, Antoine
AU - Fleming, Louise
AU - Fowler, Stephen J
AU - Gupta, Atul
AU - Hamelmann, Eckard
AU - Hashimoto, Simone
AU - Hedlin, Gunilla
AU - Koppelman, Gerard H
AU - Melén, Erik
AU - Murray, Clare S
AU - Pilette, Charles
AU - Porsbjerg, Celeste
AU - Pike, Katharine C
AU - Rusconi, Franca
AU - Williams, Clare
AU - Ahrens, Birgit
AU - Alter, Peter
AU - Anckers, Freja
AU - van den Berge, Maarten
AU - Blumchen, Katharina
AU - Brusselle, Guy
AU - Clarke, Graham W
AU - Cunoosamy, Danen
AU - Dahlén, Barbro
AU - Dixey, Piers
AU - Exley, Andrew
AU - Frey, Urs
AU - Gaillard, Erol A
AU - Giovannini-Chami, Lisa
AU - Grigg, Jonathan
AU - Hartenstein, Diana
AU - Heaney, Liam G
AU - Karadag, Bülent
AU - Kaul, Susanne
AU - Kull, Inger
AU - Licari, Amelia
AU - Maitland-van der Zee, Anke H
AU - Mahler, Vera
AU - Turner, Steve
N1 - Copyright ©The authors 2022. For reproduction rights and permissions contact [email protected].
PY - 2022/10/13
Y1 - 2022/10/13
N2 - 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 (FEV
1) 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.
AB - 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 (FEV
1) 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.
U2 - 10.1183/13993003.00606-2022
DO - 10.1183/13993003.00606-2022
M3 - Review article
C2 - 36229046
SN - 0903-1936
JO - The European respiratory journal
JF - The European respiratory journal
ER -
