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Khaleva, E; Rattu, A; Brightling, C; Bush, A; Bossios, A; Bourdin, A; Chung, KF; Chaudhuri, R; Coleman, C; Dahlén, SE; Djukanovic, R; Deschildre, A; Fleming, L; Fowler, SJ; Gupta, A; Hamelmann, E; Hashimoto, S; Hedlin, G; Koppelman, GH; Melén, E; Murray, CS; Pilette, C; Porsbjerg, C; Pike, KC; Rusconi, F; Williams, C; Ahrens, B; Alter, P; Anckers, F; van, den, Berge, M; Blumchen, K; Brusselle, G; Clarke, GW; Cunoosamy, D; Dahlén, B; Dixey, P; Exley, A; Frey, U; Gaillard, EA; Giovannini-Chami, L; Grigg, J; Hartenstein, D; Heaney, LG; Karadag, B; Kaul, S; Kull, I; Licari, A; Maitland-van, der, Zee, AH; Mahler, V; Schoos, AM; Nagakumar, P; Negus, J; Nielsen, H; Paton, J; Pijnenburg, M; Ramiconi, V; Romagosa, Vilarnau, S; Principe, S; Rutjes, N; Saglani, S; Seddon, P; Singer, F; Staudinger, H; Turner, S; Vijverberg, S; Winders, T; Yasinska, V; Roberts, G, , COMSA, Working, Group, in, the, 3TR, Consortium.
Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA).
Eur Respir J. 2023; 61(4): 2200606 Doi: 10.1183/13993003.00606-2022 [OPEN ACCESS]
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Co-authors Med Uni Graz: Singer Florian
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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 (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.
Find related publications in this database (using NLM MeSH Indexing): Child - administration & dosage; Humans - administration & dosage; Adult - administration & dosage; Quality of Life - administration & dosage; Reproducibility of Results - administration & dosage; Disease Progression - administration & dosage; Asthma - drug therapy; Outcome Assessment, Health Care - administration & dosage; Anti-Asthmatic Agents - therapeutic use