Developing and testing a toolkit of interventions to improve adherence to non-invasive ventilation in children: the SPIRITUS study protocol.

introductionNon-invasive ventilation (NIV) is a known effective and safe treatment for children and young people with sleep disordered breathing (SDB). Adherence can be challenging and poor adherence risks undertreatment of SDB. While the risk factors for non-adherence have been widely reported, very few interventions have been tested in any capacity to address barriers to adherence. METHODS AND ANALYSIS: We will conduct a mixed methods study over three phases. The aim is to identify the components of a toolkit of interventions to address some of the barriers to NIV usage in children and young people who have SDB. We will test these components for their feasibility and acceptability to families. We will also aim to identify health outcomes from NIV use that are important to families. Qualitative data will be managed using NVivo software and analysed using the Framework method. Quantitative data will be analysed using descriptive statistics. ETHICS AND DISSEMINATION: The study will run from January 2023 to October 2025. This study has ethics and local site approval. Data will be stored and accessed only by the research team, stored on a secure server. Data will be pseudo-anonymised prior to analysis and presented in a way that no individual can be identified. We will disseminate widely to relevant stakeholders including peer-reviewed journals, presentations to academic and clinical audiences at conferences and meetings and a lay report. TRIAL REGISTRATION NUMBER: ISRCTN56845190.