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@article{Khaleva:2023:10.1183/13993003.00606-2022,
author = {Khaleva, E and Rattu, A and Brightling, C and Bush, A and Bossios, A and Bourdin, A and Chung, KF and Chaudhuri, R and Coleman, C and Dahlen, S-E and Djukanovic, R and Deschildre, A and Fleming, L and Fowler, SJ and Gupta, A and Hamelmann, E and Hashimoto, S and Hedlin, G and Koppelman, GH and Melen, E and Murray, CS and Pilette, C and Porsbjerg, C and Pike, KC and Rusconi, F and Williams, C and Ahrens, B and Alter, P and Anckers, F and van, den Berge M and Blumchen, K and Brusselle, G and Clarke, GW and Cunoosamy, D and Dahlen, B and Dixey, P and Exley, A and Frey, U and Gaillard, EA and Giovannini-Chami, L and Grigg, J and Hartenstein, D and Heaney, LG and Karadag, B and Kaul, S and Kull, I and Licari, A and Maitland-van, der Zee AH and Mahler, V and Schoos, A-MM and Nagakumar, P and Negus, J and Nielsen, H and Paton, J and Pijnenburg, M and Ramiconi, V and Vilarnau, SR and Principe, S and Rutjes, N and Saglani, S and Seddon, P and Singer, F and Staudinger, H and Turner, S and Vijver},
doi = {10.1183/13993003.00606-2022},
journal = {European Respiratory Journal},
title = {Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)},
url = {http://dx.doi.org/10.1183/13993003.00606-2022},
volume = {61},
year = {2023}
}

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TY  - JOUR
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 (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria.Results Both adult and paediatric COM sets include forced expiratory volume in 1s (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 or Childhood Asthma Control Test, while the adult COM set includes the Severe Asthma Questionnaire and 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.
AU  - Khaleva,E
AU  - Rattu,A
AU  - Brightling,C
AU  - Bush,A
AU  - Bossios,A
AU  - Bourdin,A
AU  - Chung,KF
AU  - Chaudhuri,R
AU  - Coleman,C
AU  - Dahlen,S-E
AU  - Djukanovic,R
AU  - Deschildre,A
AU  - Fleming,L
AU  - Fowler,SJ
AU  - Gupta,A
AU  - Hamelmann,E
AU  - Hashimoto,S
AU  - Hedlin,G
AU  - Koppelman,GH
AU  - Melen,E
AU  - Murray,CS
AU  - Pilette,C
AU  - Porsbjerg,C
AU  - Pike,KC
AU  - Rusconi,F
AU  - Williams,C
AU  - Ahrens,B
AU  - Alter,P
AU  - Anckers,F
AU  - van,den Berge M
AU  - Blumchen,K
AU  - Brusselle,G
AU  - Clarke,GW
AU  - Cunoosamy,D
AU  - Dahlen,B
AU  - Dixey,P
AU  - Exley,A
AU  - Frey,U
AU  - Gaillard,EA
AU  - Giovannini-Chami,L
AU  - Grigg,J
AU  - Hartenstein,D
AU  - Heaney,LG
AU  - Karadag,B
AU  - Kaul,S
AU  - Kull,I
AU  - Licari,A
AU  - Maitland-van,der Zee AH
AU  - Mahler,V
AU  - Schoos,A-MM
AU  - Nagakumar,P
AU  - Negus,J
AU  - Nielsen,H
AU  - Paton,J
AU  - Pijnenburg,M
AU  - Ramiconi,V
AU  - Vilarnau,SR
AU  - Principe,S
AU  - Rutjes,N
AU  - Saglani,S
AU  - Seddon,P
AU  - Singer,F
AU  - Staudinger,H
AU  - Turner,S
AU  - Vijverberg,S
AU  - Winders,T
AU  - Yasinska,V
AU  - Roberts,G
DO  - 10.1183/13993003.00606-2022
PY  - 2023///
SN  - 0903-1936
TI  - Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)
T2  - European Respiratory Journal
UR  - http://dx.doi.org/10.1183/13993003.00606-2022
UR  - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:001003527100001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=a2bf6146997ec60c407a63945d4e92bb
UR  - https://erj.ersjournals.com/content/61/4/2200606
UR  - http://hdl.handle.net/10044/1/107906
VL  - 61
ER  -

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