The aim of our study is to establish an internationally agreed minimum core outcome set specifically for clinical trials evaluating escalated treatments for paediatric acute severe asthma (ages 2-17), with broad international stakeholder representation across all WHO regions, including clinicians and parents/caregivers. In addition, our project includes a parallel consensus process to develop a standardised definition of "acute severe asthma" for use in future clinical trials, addressing an important source of heterogeneity that has limited comparison between previous studies
Our study differs to existing core outcome set studies in asthma which have primarily focused on childhood asthma across the broader disease spectrum, chronic severe asthma and treatment response, or moderate-to-severe asthma more generally.
Contributors include:
1. Dr Charmaine Gray (Principle Investigator)
2. Ms Leah Armit
3. Professor Franz E Babl
4. Professor Colin Powell
5. Associate Professor Adriana Yock-Corrales
6. Professor Indumathy Santhanam
7. Professor Michael D. Johnson
8. Professor Stuart Dalziel
9. Associate Professor Gene Ong Yong-Kwang
10. Dr Morgan M. Millar
11. Professor Suzanna Schuh
12. Professor Jose Irazuzta
13. Dr Sebastián González-Dambrauskas
14. Dr Lilian Chebet Kimeto
15. Dr Janvier Hitayezu
16. Dr Tigist Bacha
17. Associate Professor Abate Yeshidinber
18. Professor Raghavendra Vanaki
19. Professor Romit Saxena
20. Dr Hasitha Gajaweera
21. Dr Mohammod Jobayer Chisti
22. Professor Damian Roland
23. Professor Ian Maconochie
24. Dr Jordan Evans
25. Professor Khalid Al Ansari
26. Dr Abdullah Ghanem
27. Dr Saboora Waris
28. Dr Ayeesha Saeed
29. Dr Carlos Ramon Iglesias
30. Dr Dorine Borensztajn
31. Dr Johan N. Siebert
32. Professor Simon Craig
Affiliations include:
PREDICT network
PERN
Disease Category: Lungs & airways, Child health
Disease Name: Asthma
Age Range: 2 - 17
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
This study uses a modified, international three-round Delphi methodology to develop a core outcome set for clinical trials of acute severe paediatric asthma. Clinicians who regularly manage children with acute severe asthma and parents/caregivers of children who have experienced severe asthma care are recruited across all six WHO regions. Participants rate the importance of potential outcomes on a 9-point Likert scale, with outcomes derived from a systematic review and previous international qualitative studies. Across successive rounds, participants receive feedback on their previous ratings and stakeholder-group median scores, allowing them to reconsider their responses. Pre-specified consensus criteria are applied following the final round to determine inclusion in the core outcome set, with an online consensus meeting undertaken if required. Surveys are administered through REDCap and offered in multiple languages to support global participation.