Evidence map›Paper›PMID 36229046›Full record

SynthesisThe European respiratory journal2023

Development of Core Outcome Measures sets for paediatric and adult Severe Asthma (COMSA).

Ekaterina Khaleva, Anna Rattu, Chris Brightling, Andrew Bush, Apostolos Bossios, Arnaud Bourdin, Kian Fan Chung, Rekha Chaudhuri, Courtney Coleman, Sven-Erik Dahlén and 59 more

Open access · bronzeAbstract readSystematic Review
In one paragraph

Synthesis in The European respiratory journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
5.9field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. 'What' and 'How' to Measure in Allergy and Clinical Immunology: A Systematic Review of Core Outcome Sets and Outcome Harmonisation Processes.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2026
    Pooled it
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  5. Update on biologic and small molecules treatments in pediatric allergic diseases.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2026
    Review
  6. Article
  7. Observational
  8. Article
  9. Article
  10. Redefining asthma treatment success: bridging remission goals with patient-centred outcomes.European respiratory review : an official journal of the European Respiratory Society · 2026
    Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Recent evidence for stepping down severe asthma therapies.Current opinion in pulmonary medicine · 2025
    Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

69 authors at 20 institutions in 13 countries.

Ekaterina KhalevaClinical and Experimental Sciences and Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.ORCID 0000-0002-2220-7745
Anna RattuClinical and Experimental Sciences and Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.ORCID 0000-0002-7497-9552
Chris BrightlingInstitute for Lung Health, Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester, UK.
Andrew BushCentre for Paediatrics and Child Health and National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, UK.
Apostolos BossiosDepartment of Respiratory Medicine and Allergy, Karolinska University Hospital and Department of Medicine, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-0494-2690
Arnaud BourdinPhyMedExp, University of Montpellier, Montpellier, France.ORCID 0000-0002-4645-5209
Kian Fan ChungNational Heart and Lung Institute, Imperial College London, London, UK.
Rekha ChaudhuriInstitute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.
Courtney ColemanEuropean Lung Foundation, Sheffield, UK.
Sven-Erik DahlénDepartment of Respiratory Medicine and Allergy, Karolinska University Hospital and Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Ratko DjukanovicClinical and Experimental Sciences and Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
Antoine DeschildreCHU Lille, Unité de Pneumologie et Allergologie Pédiatrique, Hôpital Jeanne de Flandre, Lille, France.ORCID 0000-0003-2006-7221
Louise FlemingNational Heart and Lung Institute, Imperial College London, London, UK.ORCID 0000-0002-7268-7433
Stephen J FowlerFaculty 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.ORCID 0000-0002-4524-1663
Atul GuptaDepartment of Paediatric Respiratory Medicine, King's College Hospital, London, UK.ORCID 0000-0002-1610-0335
Eckard HamelmannChildren's Center Bethel, Department of Pediatrics, University Bielefeld, Bielefeld, Germany.
Simone HashimotoDepartment of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0001-8995-3817
Gunilla HedlinDepartment of Women's and Children's Health and Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden.
Gerard H KoppelmanUniversity of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Department of Pediatric Pulmonology and Pediatric Allergology, Groningen, The Netherlands.ORCID 0000-0001-8567-3252
Erik MelénDepartment of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-8248-0663
Clare S MurrayFaculty 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.
Charles PiletteDepartment of Pulmonology, Cliniques Universitaires Saint-Luc and Pole of Pulmonology, ENT and Dermatology, Institute of Experimental and Clinical Research (IREC), UCLouvain, Brussels, Belgium.
Celeste PorsbjergDepartment of Respiratory Medicine, Respiratory Research Unit, Bispebjerg Hospital, Copenhagen, Denmark.
Katharine C PikeDepartment of Paediatric Respiratory Medicine, Bristol Royal Hospital for Children, Bristol, UK.
Franca RusconiDepartment of Mother and Child Health, Azienda USL Toscana Nord Ovest, Pisa, Italy.ORCID 0000-0002-9544-6472
Clare WilliamsEuropean Lung Foundation, Sheffield, UK.
Birgit AhrensDivision of Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
Peter AlterDepartment of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR), Marburg, Germany.ORCID 0000-0002-2115-1743
Freja Anckers3TR Respiratory Patient Working Group, Brussels, Belgium.
Maarten van den BergeUniversity of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.
Katharina BlumchenDepartment of Children and Adolescent Medicine, Division of Pneumology, Allergology, Cystic Fibrosis, University Hospital Frankfurt, Goethe-University, Frankfurt, Germany.
Guy BrusselleDepartment of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0001-7021-8505
Graham W ClarkeTranslational Science and Experimental Medicine, Research and Early Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden g.c.roberts@soton.ac.uk.
Danen CunoosamyGlobal Medical Affairs Respiratory, Allergy and GI, Sanofi Genzyme, Cambridge, MA, USA.
Barbro DahlénDepartment of Respiratory Medicine and Allergy, Karolinska University Hospital and Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Piers DixeyNational Heart and Lung Institute, Imperial College London, London, UK.ORCID 0000-0003-3080-8978
Andrew ExleyAdept Biologica Consulting Limited, London, UK.
Urs FreyUniversity Children's Hospital Basel, University of Basel, Basel, Switzerland.
Erol A GaillardDepartment of Respiratory Sciences, Leicester NIHR Biomedical Research Centre (Respiratory Theme), University of Leicester, Leicester, UK.
Lisa Giovannini-ChamiPediatric Pulmonology and Allergology Department, Hôpitaux Pédiatriques de Nice CHU-Lenval, Nice, France.
Jonathan GriggCentre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.ORCID 0000-0003-3109-6028
Diana HartensteinDivision of Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
Liam G HeaneyWellcome-Wolfson Centre for Experimental Medicine School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK.
Bülent KaradagDivision of Pediatric Pulmonology, Marmara University Faculty of Medicine, Istanbul, Turkey.
Susanne KaulDivision of Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
Inger KullDepartment of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Amelia LicariPediatric Clinic, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy.
Anke H Maitland-van der ZeeDepartment of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
Vera MahlerDivision of Allergology, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
Ann-Marie M SchoosCOpenhagen Prospective Studies on Asthma in Childhood (COPSAC), Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
Prasad NagakumarDepartment of Respiratory Medicine, Birmingham Children's Hospital, Birmingham, UK.
Jenny Negus3TR Respiratory Patient Working Group, Brussels, Belgium.
Hanna Nielsen3TR Respiratory Patient Working Group, Brussels, Belgium.
James PatonSchool of Medicine, College of Medical, Veterinary, and Life Sciences, University of Glasgow, Glasgow, UK.
Mariëlle PijnenburgErasmus MC - Sophia Children's Hospital, University Medical Centre Rotterdam, Department of Paediatrics/Paediatric Respiratory Medicine and Allergology, Rotterdam, The Netherlands.
Valeria RamiconiEuropean Federation of Allergy and Airways Diseases Patients' Associations, Brussels, Belgium.
Sofia Romagosa VilarnauEuropean Federation of Allergy and Airways Diseases Patients' Associations, Brussels, Belgium.
Stefania PrincipeDepartment of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Niels RutjesDepartment of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
Sejal SaglaniNational Heart and Lung Institute, Imperial College London, London, UK.
Paul SeddonRespiratory Care, Royal Alexandra Children's Hospital, Brighton, UK.
Florian SingerDepartment of Respiratory Medicine, University Children's Hospital Zurich and Childhood Research Center, Zurich, Switzerland.ORCID 0000-0003-3471-5664
Heribert StaudingerTherapeutic Area Immunology and Inflammation, Sanofi Genzyme, Bridgewater, NJ, USA.
Steve TurnerWomen and Children Division, NHS Grampian, Aberdeen, UK.ORCID 0000-0001-8393-5060
Susanne VijverbergDepartment of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands.
Tonya WindersAllergy & Asthma Network, Vienna, VA, USA.
Valentyna YasinskaDepartment of Respiratory Medicine and Allergy, Karolinska University Hospital and Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Graham RobertsClinical and Experimental Sciences and Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.ORCID 0000-0003-2252-1248
COMSA Working Group in the 3TR Consortium
Emma Kinderziekenhuis · NLKarolinska Institutet · SEKarolinska University Hospital · SEPaul Ehrlich Institut · DEEuropean Federation of Allergy and Airways Diseases Patients Associations · BEImperial College London · GBBritish Lung Foundation · GBNational Patient Safety Foundation · USRoyal Brompton Hospital · GBUniversity Hospital Southampton NHS Foundation Trust · GBUniversity Medical Center Groningen · NLUniversity of Glasgow · GBUniversity of Leicester · GBUniversity of Southampton · GBAstraZeneca (Finland) · FIAzienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo · ITAzienda Usl Toscana Centro · ITBirmingham Children's Hospital · GBBispebjerg Hospital · DKBristol Royal Hospital for Children · GB

Funding

Medical Research Council MR/T010371/1
6 · The paper itself

Abstract

backgroundEffectiveness 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.

methodsCOMSA 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.

resultsBoth adult and paediatric COM sets include forced expiratory volume in 1 s (FEV

conclusionsThis 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.

Indexed as

Anti-Asthmatic AgentsAsthmaAdultChildDisease ProgressionHumansOutcome Assessment, Health CareQuality of LifeReproducibility of ResultsAnti-Asthmatic Agents

Identifiers

PMID36229046
PMCPMC10069873
OpenAlexW4304957297

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.