Abstract
BackgroundBronchiolitis is an acute lower respiratory infection which predominantly affects young children. Treatment for bronchiolitis is limited to supportive therapy. Nasal oxygen therapy is part of routine care, and delivery now incorporates varying levels of non-invasive continuous positive airway pressure and/or high-flow nasal cannula oxygen therapy. Despite wide clinical use, there remains a lack of evidence on the comparative effectiveness and safety of these interventions. Furthermore, research in this field is hampered by the use of multiple outcome measures in current clinical trials.Methods/designThis mixed methods study includes a systematic review of outcome measures, telephone interviews with parents, focus group workshops and a Delphi survey with healthcare professionals and parents. These methods will be used to identify and prioritise outcomes for inclusion in a core outcome set and to explore issues pertinent to the design of a future randomised controlled trial comparing different modes of oxygen therapy for bronchiolitis. UK hospitals will also be contacted and asked to complete a survey to provide an overview of current practice to enable assessment of capability and capacity to run a future clinical trial.DiscussionThis study will facilitate the design of a future clinical trial of non-invasive ventilation in children with bronchiolitis which is acceptable to important stakeholders. Furthermore, core outcome set development will improve standardisation, measurement and reporting of clinically important outcomes in bronchiolitis.Trial registrationISRCTN Registry, ISRCTN75766048. Registered on 18 December 2017. This study was retrospectively registered in the ISRCTN Registry and on the Core Outcome Measures in Effectiveness Trials (COMET) Initiative database (15 September 2017).
Highlights
Bronchiolitis is an acute lower respiratory infection which predominantly affects young children
This study will facilitate the design of a future clinical trial of non-invasive ventilation in children with bronchiolitis which is acceptable to important stakeholders
One of the key limitations identified by most systematic reviews of treatments in acute viral bronchiolitis across different settings has been the heterogeneity in the selection of outcomes and measurements reported in clinical trials [49]
Summary
This feasibility study protocol describes how we plan to design a future clinical trial to investigate the efficacy of non-invasive ventilatory support and the development of a COS for children with bronchiolitis. We will involve and consult important stakeholders throughout this study This important contribution will help ensure that future research outputs, in terms of the clinical trial and COS, will be both acceptable and relevant to all major stakeholder groups. A limitation with respect to stakeholder involvement is the lack of engagement with industry partners as participants These stakeholders were not considered for inclusion because, at the time the protocol for this study was developed, there were no specific treatments for either bronchiolitis or the viruses that cause bronchiolitis.
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