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Peer-reviewedCC BY 4.0BMJ Open

Establishing a core outcome set for use in trials of severe acute paediatric asthma exacerbation (2–17 years): study protocol for an international co-design Delphi survey – a Paediatric Emergency Research Network study initiative

  • Charmaine Gray1,2,3
  • Leah Armit1,3
  • Franz E Babl3,4,5,6
  • Colin Powell7
  • Adriana Yock-Corrales8,9
  • Indumathy Santhanam10,11
  • Michael D Johnson12,13,14
  • Stuart Dalziel3,15,16
  • Gene Ong Yong-Kwang17
  • Morgan M Millar18
  • Suzanna Schuh19
  • Jose Irazuzta20
20 more authors
  • Sebastián González21,22
  • Lilian Chebet Kimeto23,24
  • Janvier Hitayezu25
  • Tigist Bacha26
  • Abate Yeshidinber26
  • Raghavendra Vanaki11,27
  • Romit Saxena28
  • Hasitha Gajaweera29
  • Mohammod Jobayer Chisti30
  • Damian Roland31,32
  • Ian Maconochie33
  • Jordan Evans34
  • Khalid Alansari35
  • Abdullah Ghanem36
  • Saboora Waris37
  • Ayeesha Saeed38
  • Carlos Ramon Iglesias39
  • Dorine Borensztajn40
  • Johan N Siebert
  • Simon Craig
40 affiliations
  1. 1Emergency Department, Flinders Medical Centre, Bedford Park, South Australia, Australia
  2. 2College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
  3. 3Departments International Collaborative, PREDICT Paediatric Research in Emergency, Melbourne, Victoria, Australia
  4. 4Emergency Department, The Royal Children’s Hospital Melbourne, Melbourne, Victoria, Australia
  5. 5Murdoch Children’s Research Institute, Clinical Sciences, Parkville, Victoria, Australia
  6. 6Department of Paediatrics and Department of Critical Care, The University of Melbourne, Parkville, Victoria, Australia
  7. 7School of Medicine, Cardiff University, Cardiff, UK
  8. 8National Children’s Hospital, San Jose, Costa Rica
  9. 9University of Costa Rica, San Jose, Costa Rica
  10. 10Regional Collaborative Center, Institute of Child Health, Madras Medical College, Chennai, India
  11. 11Pediatric Resuscitation and Emergency Research Network (PRERNI), India, India
  12. 12Primary Children’s Hospital, Salt Lake City, Utah, USA
  13. 13Department of Pediatrics, The University of Utah School of Medicine, Salt Lake City, Utah, USA
  14. 14Pediatric Emergency Care Applied Research Network, Salt Lake City, Utah, USA
  15. 15Departments of Surgery and Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand
  16. 16Children’s Emergency Department, Starship Children’s Health, Auckland, New Zealand
  17. 17Department of Emergency Medicine, KK Women’s and Children’s Hospital, Singapore
  18. 18University of Utah School of Medicine, Salt Lake City, Utah, USA
  19. 19Division of Paediatric Emergency Medicine and Research Institute, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada
  20. 20University of Florida, Gainesville, Florida, USA
  21. 21Red Colaborativa Pediatrica de Latinoamercia, Montevideo, Uruguay
  22. 22Unidad de Cuidados Intensivos de Niños del Centro Hospitalario Pereira Rossell, Facultad de Medicina, Universidad de la Republica, Montevideo, Uruguay
  23. 23Department of Paediatrics and Child Health, Kenyatta University, Nairobi, Kenya
  24. 24Mater Misericordiae Hospital, Nairobi, Kenya
  25. 25Centre Hospitalier Universitaire de Kigali, Kigali, Rwanda
  26. 26St Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia
  27. 27Hanagal Shri Kumareshwar Hospital and Research Centre Hospital, Bagalkot, India
  28. 28Department of Paediatrics, Maulana Azad Medical College, New Delhi, India
  29. 29Asiri Hospital Galle Queensbury, Karagitiva, Sri Lanka
  30. 30Clinical Sciences Division (CSD), Centre for Nutrition and Food Security (CNFS), International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh
  31. 31Emergency Department, Paediatric Emergency Medicine Leicester Academic (PEMLA) Group, Leicester, UK
  32. 32SAPPHIRE Group, Department of Health Sciences, University of Leicester, Leicester, UK
  33. 33Imperial College London, London, UK
  34. 34University Hospital of Wales, Cardiff, UK
  35. 35Sidra Medicine, Emergency Medicine, Doha, Qatar
  36. 36Emergency Department, Fakeeh University Hospital, Dubai, UAE
  37. 37Maroof Clinical Trial Unit, Research Department, Maroof International Hospital, Islamabad, Pakistan
  38. 38Emergency Department, HITEC-IMS, Taxila, Punjab, Pakistan
  39. 39Hospital Universitaria de mataro, Barcelona, Spain
  40. 40Department of Pediatrics, Northwest Clinics, Alkmaar & Den Helder, Netherlands
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Abstract

Introduction: Asthma is one of the most common chronic diseases of childhood and a leading cause of emergency department (ED) presentations worldwide. However, for those experiencing a severe exacerbation, there is a limited evidence base to decide which treatment works best. A major contributor to this, is the considerable heterogeneity in outcome selection which limits comparison between trials. The development of a core outcome set (COS) may improve this, enhancing the quality, comparability and applicability of future research. This protocol describes the development of the first internationally derived COS for trials evaluating interventions in severe, acute asthma exacerbations.

Methods and analysis: A modified Delphi methodology will be used. An international steering committee comprising experts has been established through the Paediatric Emergency Research Network Asthma Working Group. For participants, this study will seek balanced representation across the six WHO regions and include clinicians who regularly manage children with severe acute asthma exacerbations and parents of children previously hospitalised with an asthma exacerbation. A target of 180 participants will be recruited, allowing for an anticipated 30% attrition rate between rounds and approximately 80 participants completing the final round. Three rounds of online surveys will be undertaken. Participants will rate the importance of outcomes identified through a systematic review and qualitative studies, with opportunities to suggest modifications and additional outcomes. Consensus after round 3 will be defined as either: (1) ≥70% of participants from both stakeholder groups scoring an outcome as critically important (7–9 on a 9-point Likert scale) and ≤15% scoring it as of limited importance (1–3) or (2) ≥90% of participants from either stakeholder group scoring the outcome as critically important.

Ethics and dissemination: Ethical approval was granted by the Southern Adelaide Health Human Research Ethics Committee (HREC reference number 2025/HRE00375). Findings will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagement activities.

This study has been prospectively registered with the Core Outcome Measures in Effectiveness Trials (COMET), registration number 1016.

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Cite

BibTeXRIS
BibTeX
@article{gray2026establishing,
  title = {{Establishing a core outcome set for use in trials of severe acute paediatric asthma exacerbation (2–17 years): study protocol for an international co-design Delphi survey – a Paediatric Emergency Research Network study initiative}},
  author = {Charmaine Gray and Leah Armit and Franz E Babl and Colin Powell and Adriana Yock-Corrales and Indumathy Santhanam and Michael D Johnson and Stuart Dalziel and Gene Ong Yong-Kwang and Morgan M Millar and Suzanna Schuh and Jose Irazuzta and Sebastián González and Lilian Chebet Kimeto and Janvier Hitayezu and Tigist Bacha and Abate Yeshidinber and Raghavendra Vanaki and Romit Saxena and Hasitha Gajaweera and Mohammod Jobayer Chisti and Damian Roland and Ian Maconochie and Jordan Evans and Khalid Alansari and Abdullah Ghanem and Saboora Waris and Ayeesha Saeed and Carlos Ramon Iglesias and Dorine Borensztajn and Johan N Siebert and Simon Craig},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-124611},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124611},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Establishing a core outcome set for use in trials of severe acute paediatric asthma exacerbation (2–17 years): study protocol for an international co-design Delphi survey – a Paediatric Emergency Research Network study initiative
AU  - Charmaine Gray
AU  - Leah Armit
AU  - Franz E Babl
AU  - Colin Powell
AU  - Adriana Yock-Corrales
AU  - Indumathy Santhanam
AU  - Michael D Johnson
AU  - Stuart Dalziel
AU  - Gene Ong Yong-Kwang
AU  - Morgan M Millar
AU  - Suzanna Schuh
AU  - Jose Irazuzta
AU  - Sebastián González
AU  - Lilian Chebet Kimeto
AU  - Janvier Hitayezu
AU  - Tigist Bacha
AU  - Abate Yeshidinber
AU  - Raghavendra Vanaki
AU  - Romit Saxena
AU  - Hasitha Gajaweera
AU  - Mohammod Jobayer Chisti
AU  - Damian Roland
AU  - Ian Maconochie
AU  - Jordan Evans
AU  - Khalid Alansari
AU  - Abdullah Ghanem
AU  - Saboora Waris
AU  - Ayeesha Saeed
AU  - Carlos Ramon Iglesias
AU  - Dorine Borensztajn
AU  - Johan N Siebert
AU  - Simon Craig
PY  - 2026
DA  - 2026/10/29
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-124611
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124611
AB  - Introduction: Asthma is one of the most common chronic diseases of childhood and a leading cause of emergency department (ED) presentations worldwide. However, for those experiencing a severe exacerbation, there is a limited evidence base to decide which treatment works best. A major contributor to this, is the considerable heterogeneity in outcome selection which limits comparison between trials. The development of a core outcome set (COS) may improve this, enhancing the quality, comparability and applicability of future research. This protocol describes the development of the first internationally derived COS for trials evaluating interventions in severe, acute asthma exacerbations.  Methods and analysis: A modified Delphi methodology will be used. An international steering committee comprising experts has been established through the Paediatric Emergency Research Network Asthma Working Group. For participants, this study will seek balanced representation across the six WHO regions and include clinicians who regularly manage children with severe acute asthma exacerbations and parents of children previously hospitalised with an asthma exacerbation. A target of 180 participants will be recruited, allowing for an anticipated 30% attrition rate between rounds and approximately 80 participants completing the final round. Three rounds of online surveys will be undertaken. Participants will rate the importance of outcomes identified through a systematic review and qualitative studies, with opportunities to suggest modifications and additional outcomes. Consensus after round 3 will be defined as either: (1) ≥70% of participants from both stakeholder groups scoring an outcome as critically important (7–9 on a 9-point Likert scale) and ≤15% scoring it as of limited importance (1–3) or (2) ≥90% of participants from either stakeholder group scoring the outcome as critically important.  Ethics and dissemination: Ethical approval was granted by the Southern Adelaide Health Human Research Ethics Committee (HREC reference number 2025/HRE00375). Findings will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagement activities.  This study has been prospectively registered with the Core Outcome Measures in Effectiveness Trials (COMET), registration number 1016.
SN  - 2044-6055
SN  - 2044-6055
ER  -