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Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA).
Khaleva, Ekaterina; Rattu, Anna; Brightling, Chris; Bush, Andrew; Bossios, Apostolos; Bourdin, Arnaud; Chung, Kian Fan; Chaudhuri, Rekha; Coleman, Courtney; Dahlén, Sven-Erik; Djukanovic, Ratko; Deschildre, Antoine; Fleming, Louise; Fowler, Stephen J; Gupta, Atul; Hamelmann, Eckard; Hashimoto, Simone; Hedlin, Gunilla; Koppelman, Gerard H; Melén, Erik; Murray, Clare S; Pilette, Charles; Porsbjerg, Celeste; Pike, Katharine C; Rusconi, Franca; Williams, Clare; Ahrens, Birgit; Alter, Peter; Anckers, Freja; van den Berge, Maarten; Blumchen, Katharina; Brusselle, Guy; Clarke, Graham W; Cunoosamy, Danen; Dahlén, Barbro; Dixey, Piers; Exley, Andrew; Frey, Urs; Gaillard, Erol A; Giovannini-Chami, Lisa; Grigg, Jonathan; Hartenstein, Diana; Heaney, Liam G; Karadag, Bülent; Kaul, Susanne; Kull, Inger; Licari, Amelia; Maitland-van der Zee, Anke H; Mahler, Vera; Schoos, Ann-Marie M.
Affiliation
  • Khaleva E; Clinical and Experimental Sciences and Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
  • Rattu A; Clinical and Experimental Sciences and Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
  • Brightling C; Institute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester, UK.
  • Bush A; Centre for Paediatrics and Child Health and National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, UK.
  • Bossios A; Department of Respiratory Medicine and Allergy, Karolinska University Hospital and Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
  • Bourdin A; PhyMedExp, University of Montpellier, Montpellier, France.
  • Chung KF; National Heart and Lung Institute, Imperial College London, London, UK.
  • Chaudhuri R; Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.
  • Coleman C; European Lung Foundation, Sheffield, UK.
  • Dahlén SE; Department of Respiratory Medicine and Allergy, Karolinska University Hospital and Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
  • Djukanovic R; Clinical and Experimental Sciences and Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
  • Deschildre A; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
  • Fleming L; CHU Lille, Unité de Pneumologie et Allergologie Pédiatrique, Hôpital Jeanne de Flandre, Lille, France.
  • Fowler SJ; Université de Lille, U1019 - UMR 8204 - CIIL (Center for Infection and Immunity of Lille), Lille, France.
  • Gupta A; National Heart and Lung Institute, Imperial College London, London, UK.
  • Hamelmann E; Faculty of Biology, Medicine and Health, School of Biological Sciences, Division of Infection, Immunity and Respiratory Medicine, University of Manchester, NIHR Manchester Biomedical Research Unit, Manchester University NHS Foundation Trust, Manchester, UK.
  • Hashimoto S; Department of Paediatric Respiratory Medicine, King's College Hospital, London, UK.
  • Hedlin G; Children's Center Bethel, Department of Pediatrics, University Bielefeld, Bielefeld, Germany.
  • Koppelman GH; Department of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
  • Melén E; Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
  • Murray CS; Department of Women's and Children's Health and Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden.
  • Pilette C; University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Pediatric Pulmonology and Pediatric Allergology, Groningen, The Netherlands.
  • Porsbjerg C; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.
  • Pike KC; Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
  • Rusconi F; Faculty of Biology, Medicine and Health, School of Biological Sciences, Division of Infection, Immunity and Respiratory Medicine, University of Manchester, NIHR Manchester Biomedical Research Unit, Manchester University NHS Foundation Trust, Manchester, UK.
  • Williams C; Department of Pulmonology, Cliniques Universitaires Saint-Luc and Pole of Pulmonology, ENT and Dermatology, Institute of Experimental and Clinical Research (IREC), UCLouvain, Brussels, Belgium.
  • Ahrens B; Department of Respiratory Medicine, Respiratory Research Unit, Bispebjerg Hospital, Copenhagen, Denmark.
  • Alter P; Department of Paediatric Respiratory Medicine, Bristol Royal Hospital for Children, Bristol, UK.
  • Anckers F; Department of Mother and Child Health, Azienda USL Toscana Nord Ovest, Pisa, Italy.
  • van den Berge M; European Lung Foundation, Sheffield, UK.
  • Blumchen K; Division of Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
  • Brusselle G; Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR), Marburg, Germany.
  • Clarke GW; 3TR Respiratory Patient Working Group, Brussels, Belgium.
  • Cunoosamy D; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.
  • Dahlén B; University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, The Netherlands.
  • Dixey P; Department of Children and Adolescent Medicine, Division of Pneumology, Allergology, Cystic Fibrosis, University Hospital Frankfurt, Goethe-University, Frankfurt, Germany.
  • Exley A; Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
  • Frey U; Translational Science and Experimental Medicine, Research and Early Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden g.c.roberts@soton.ac.uk.
  • Gaillard EA; Global Medical Affairs Respiratory, Allergy and GI, Sanofi Genzyme, Cambridge, MA, USA.
  • Giovannini-Chami L; Department of Respiratory Medicine and Allergy, Karolinska University Hospital and Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
  • Grigg J; National Heart and Lung Institute, Imperial College London, London, UK.
  • Hartenstein D; Royal Brompton Hospital, London, UK.
  • Heaney LG; Adept Biologica Consulting Limited, London, UK.
  • Karadag B; University Children's Hospital Basel, University of Basel, Basel, Switzerland.
  • Kaul S; Department of Respiratory Sciences, Leicester NIHR Biomedical Research Centre (Respiratory Theme), University of Leicester, Leicester, UK.
  • Kull I; Pediatric Pulmonology and Allergology Department, Hôpitaux Pédiatriques de Nice CHU-Lenval, Nice, France.
  • Licari A; Université Côte d'Azur, Nice, France.
  • Maitland-van der Zee AH; Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.
  • Mahler V; Division of Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
  • Schoos AM; Wellcome-Wolfson Centre for Experimental Medicine School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
Eur Respir J ; 61(4)2023 04.
Article in En | MEDLINE | ID: mdl-36229046
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Asthma / Anti-Asthmatic Agents Type of study: Prognostic_studies / Systematic_reviews Limits: Adult / Child / Humans Language: En Journal: Eur Respir J Year: 2023 Type: Article Affiliation country: United kingdom
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Asthma / Anti-Asthmatic Agents Type of study: Prognostic_studies / Systematic_reviews Limits: Adult / Child / Humans Language: En Journal: Eur Respir J Year: 2023 Type: Article Affiliation country: United kingdom