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Development of core outcome measures sets for paediatric and adult severe asthma (COMSA)

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dc.contributor.authorKARADAĞ, BÜLENT TANER
dc.contributor.authorsKhaleva E., Rattu A., Brightling C., Bush A., Bossios A., Bourdin A., Chung K. F., Chaudhuri R., Coleman C., Dahlén S., et al.
dc.date.accessioned2023-05-08T08:07:42Z
dc.date.available2023-05-08T08:07:42Z
dc.date.issued2023-04-01
dc.description.abstractBackground 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 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 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.
dc.identifier.citationKhaleva E., Rattu A., Brightling C., Bush A., Bossios A., Bourdin A., Chung K. F., Chaudhuri R., Coleman C., Dahlén S., et al., "Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA)", European Respiratory Journal, cilt.61, sa.4, 2023
dc.identifier.doi10.1183/13993003.00606-2022
dc.identifier.issn0903-1936
dc.identifier.issue4
dc.identifier.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85148996792&origin=inward
dc.identifier.urihttps://hdl.handle.net/11424/289161
dc.identifier.volume61
dc.language.isoeng
dc.relation.ispartofEuropean Respiratory Journal
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectTıp
dc.subjectDahili Tıp Bilimleri
dc.subjectGöğüs Hastalıkları ve Allerji
dc.subjectSağlık Bilimleri
dc.subjectMedicine
dc.subjectInternal Medicine Sciences
dc.subjectChest Diseases and Allergy
dc.subjectHealth Sciences
dc.subjectKlinik Tıp (MED)
dc.subjectKlinik Tıp
dc.subjectSOLUNUM SİSTEMİ
dc.subjectClinical Medicine (MED)
dc.subjectCLINICAL MEDICINE
dc.subjectRESPIRATORY SYSTEM
dc.subjectAkciğer ve Solunum Tıbbı
dc.subjectPulmonary and Respiratory Medicine
dc.titleDevelopment of core outcome measures sets for paediatric and adult severe asthma (COMSA)
dc.typearticle
dspace.entity.typePublication
local.avesis.id00ce744f-f87a-4c74-ba38-4a7998bea91b
local.indexed.atPUBMED
local.indexed.atSCOPUS
relation.isAuthorOfPublication218b489d-97ab-49dd-9db6-0c2a732f1999
relation.isAuthorOfPublication.latestForDiscovery218b489d-97ab-49dd-9db6-0c2a732f1999

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