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

Research output: Contribution to journalReviewResearchpeer-review

Documents

  • Fulltext

    Final published version, 1.59 MB, PDF document

  • Ekaterina Khaleva
  • Anna Rattu
  • Chris Brightling
  • Andrew Bush
  • Apostolos Bossios
  • Arnaud Bourdin
  • Kian Fan Chung
  • Rekha Chaudhuri
  • Courtney Coleman
  • Sven Erik Dahlén
  • Ratko Djukanovic
  • Antoine Deschildre
  • Louise Fleming
  • Stephen J. Fowler
  • Atul Gupta
  • Eckard Hamelmann
  • Simone Hashimoto
  • Gunilla Hedlin
  • Gerard H. Koppelman
  • Erik Melén
  • Clare S. Murray
  • Charles Pilette
  • Porsbjerg, Celeste Michala
  • Katharine C. Pike
  • Franca Rusconi
  • Clare Williams
  • Birgit Ahrens
  • Peter Alter
  • Freja Anckers
  • Maarten van den Berge
  • Katharina Blumchen
  • Guy Brusselle
  • Graham W. Clarke
  • Danen Cunoosamy
  • Barbro Dahlén
  • Piers Dixey
  • Andrew Exley
  • Urs Frey
  • Erol A. Gaillard
  • Lisa Giovannini-Chami
  • Jonathan Grigg
  • Diana Hartenstein
  • Liam G. Heaney
  • Bülent Karadag
  • Susanne Kaul
  • Inger Kull
  • Amelia Licari
  • Anke-Hilse Maitland-van der Zee
  • Vera Mahler
  • Schoos, Ann-Marie Malby
  • Prasad Nagakumar
  • Jenny Negus
  • Hanna Nielsen
  • Mariëlle Pijnenburg
  • Valeria Ramiconi
  • Sofia Romagosa Vilarnau
  • Stefania Principe
  • Niels W. P. Rutjes
  • Sejal Saglani
  • Paul C Seddon
  • Florian Singer
  • Heribert Staudinger
  • Steve Turner
  • Susanne J Vijverberg
  • Tonya Winders
  • Valentyna Yasinska
  • Graham Roberts
  • Sverrild, Asger (Member of author collaboration)
  • Therese Lapperre (Member of author collaboration)
  • COMSA Working Group in the 3TR Consortium

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.

Original languageEnglish
Article number2200606
JournalEuropean Respiratory Journal
Volume61
Issue number4
Number of pages20
ISSN0903-1936
DOIs
Publication statusPublished - 2023

Bibliographical note

Publisher Copyright:
Copyright © The authors 2023.

ID: 367714512