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Improving the management and outcomes of preschool wheeze: protocol of a prospective multicentre cohort study
Anne B Chang1,2, Stephanie T Yerkovich2,3, Steven McPhail4,5
1Child and Maternal Health Division, Menzies School of Health Research, Darwin, Northern Territory, Australia anne.chang@menzies.edu.au.
Insights
This study investigates if the WheezeScan device improves asthma diagnosis in preschool children. Early, objective wheeze detection may lead to better asthma management and outcomes.
Area of Science:
- Pediatric Pulmonology
- Medical Device Technology
- Clinical Diagnostics
Background:
- Preschool wheeze and asthma significantly impact children's health and lung function.
- Parental and physician reports of wheeze often disagree, hindering accurate diagnosis.
- Objective wheeze definition is needed for early asthma diagnosis and improved management.
Purpose of the Study:
- To determine if WheezeScan improves asthma diagnosis in preschool children (0.5-6 years) suspected of asthma.
- To assess the impact of WheezeScan on patient-reported outcomes (PROs) and healthcare costs.
- To evaluate WheezeScan's ability to objectively define wheeze and its reversibility.
Main Methods:
- A multicentre prospective cohort study involving 102 preschool children.
- Children used WheezeScan twice daily for 6 weeks, with objective wheeze detection and response to bronchodilators recorded.
- Primary endpoint: proportion of children with a definitive asthma diagnosis using WheezeScan data.
Main Results:
- The study aims to compare asthma diagnosis rates with and without WheezeScan.
- Secondary outcomes include changes in quality of life and healthcare expenditures.
- Results will indicate WheezeScan's effectiveness in objective wheeze assessment.
Conclusions:
- WheezeScan has the potential to enhance the accuracy of asthma diagnosis in young children.
- Objective data from WheezeScan may improve preschool wheeze management strategies.
- Further research will validate its clinical utility and cost-effectiveness.
Introduction:
Preschool wheeze and asthma are associated with substantial morbidity and impaired future lung function. Yet, wheeze is unreliably reported with high disagreement (>50%) between parental and physician observations. Objectively defining wheeze and its reversibility could enable an earlier asthma diagnosis and improve preschool wheeze management.Our primary aim is to determine in preschool children (aged 0.5-6 years) suspected of asthma whether adding WheezeScan to routine clinical assessment (vs assessment without WheezeScan) improves the diagnosis of asthma. Our primary hypothesis is that using WheezeScan in preschool children suspected of asthma is associated with increased definitive asthma diagnoses in this age group. Our secondary aims are to (a) examine the effect of using WheezeScan on patient-reported outcomes (PROs) and (b) healthcare costs. Our secondary hypothesis is that using WheezeScan in preschool children suspected of asthma is associated with improved quality of life without incurring additional healthcare costs.
Methods And Analysis:
Our multicentre prospective cohort study involves recruiting 102 preschool children suspected of asthma. WheezeScan, a user-friendly digital device, incorporates artificial intelligence to objectively define wheeze and its response to bronchodilators. Over 6 weeks, parents/caregivers use the WheezeScan two times per day and whenever wheezing is suspected. If wheeze is detected, an inhaled short-acting β2-agonist is administered and WheezeScan determines if wheeze resolves thereafter.Our primary endpoint is the proportion of children with a definitive asthma diagnosis, compared with baseline, based on the treating clinician's assessment using WheezeScan data. Our secondary outcomes are PROs, reflecting generic health-related quality-of-life and cough-specific (if chronic cough present) outcomes and health costs.
Ethics And Dissemination:
The Children's Health Queensland Human Research Ethics Committee (HREC/23/QCHQ/100691) and the Queensland University of Technology Office of Research Ethics and Integrity approved the study. We will publish and share results with the academic and healthcare communities and relevant patient organisations.
Trial Registration Number:
Australian New Zealand Clinical Trials Registry ACTRN12623000904673.
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