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Which outcomes should be used in future bronchiolitis trials? Developing a bronchiolitis core outcome set using a
A Rosala-Hallas1, Ashley P Jones1, Paula R Williamson2
1Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, Merseyside, UK.
Insights
This study developed the first core outcome set (COS) for bronchiolitis trials, ensuring outcomes are relevant to healthcare professionals and parents. This standardized approach will improve future clinical trial comparability and data synthesis.
Area of Science:
- Pediatrics
- Clinical Trials
- Respiratory Medicine
Background:
- Bronchiolitis is a common respiratory infection in infants.
- Current clinical trials for bronchiolitis lack a standardized set of outcome measures.
- This variability hinders comparison and synthesis of trial results.
Purpose of the Study:
- To develop a core outcome set (COS) for future clinical trials in bronchiolitis.
- To identify outcomes that are important to both healthcare professionals (HCPs) and parents.
- To prioritize outcomes for consistent use in clinical research.
Main Methods:
- Systematic review of existing literature.
- Workshops and interviews with parents and HCPs.
- A multi-round Delphi survey.
- A final consensus meeting.
Main Results:
- Fifty-six potential outcomes were identified.
- A total of 25 outcomes were included in the final COS after rigorous consensus processes.
- The COS was developed with input from 13 parents and 45 HCPs across various stages.
Conclusions:
- The first consensus-based COS for hospital-based bronchiolitis trials has been established.
- This COS will ensure relevance and comparability of outcomes in future bronchiolitis research.
- Implementation of this COS will facilitate better data synthesis and evidence generation.
Objectives:
The objective of this study was to develop a core outcome set (COS) for use in future clinical trials in bronchiolitis. We wanted to find out which outcomes are important to healthcare professionals (HCPs) and to parents and which outcomes should be prioritised for use in future clinical trials.
Design And Setting:
The study used a systematic review, workshops and interviews, a Delphi survey and a final consensus workshop.
Results:
Thirteen parents and 45 HCPs took part in 5 workshops; 15 other parents were also separately interviewed. Fifty-six items were identified from the systematic review, workshops and interviews. Rounds one and two of the Delphi survey involved 299 and 194 participants, respectively. Sixteen outcomes met the criteria for inclusion within the COS. The consensus meeting was attended by 10 participants, with representation from all three stakeholder groups. Nine outcomes were added, totalling 25 outcomes to be included in the COS.
Conclusion:
We have developed the first parent and HCP consensus on a COS for bronchiolitis in a hospital setting. The use of this COS will ensure outcomes in future bronchiolitis trials are important and relevant, and will enable the trial results to be compared and combined.
Trial Registration Number:
ISRCTN75766048.
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