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Impact of using spirometry on clinical decision making and quality of life in children: protocol for a single centre
Wicharn Boonjindasup1,2,3, Julie M Marchant3,4, Margaret S McElrea3,4
1Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia elm.boonjindasup@menzies.edu.au.
Insights
This study investigates if routine spirometry improves clinical decisions and outcomes for children with respiratory diseases. The randomized controlled trial aims to provide evidence on the benefits of spirometry in pediatric practice.
Area of Science:
- Pediatric Respiratory Medicine
- Clinical Trials
Background:
- Spirometry is underutilized in pediatric practice despite its availability.
- Limited evidence exists on the impact of routine spirometry on clinical decision-making and patient outcomes in children.
Purpose of the Study:
- To evaluate the effect of routine spirometry on clinical decision-making in children with respiratory diseases.
- To assess the impact of spirometry on patient-related outcome measures (PROMs) and quality of life (QoL) in pediatric patients.
Main Methods:
- A randomized controlled trial involving 106 children (aged 4-18 years) at Queensland Children's Hospital.
- Children were randomized to receive clinical review with or without spirometry.
- Primary outcome: change in clinical decision-making; Secondary outcomes: PROMs, opinions on spirometry, and diagnostic certainty.
Main Results:
- This is a pre-results abstract; therefore, no results are available.
- The study is ongoing, with results to be disseminated upon completion.
Conclusions:
- The study aims to provide crucial evidence on the utility of spirometry in pediatric respiratory care.
- Findings are expected to inform clinical practice guidelines regarding the use of spirometry in children.
Introduction:
Although spirometry has been available for decades, it is underused in paediatric practice, other than in specialist clinics. This is unsurprising as there is limited evidence on the benefit of routine spirometry in improving clinical decision making and/or outcomes for children. We hypothesised that using spirometry for children being evaluated for respiratory diseases impacts on clinical decision making and/or improves patient-related outcome measures (PROMs) and/or quality of life (QoL), compared with not using spirometry.
Methods And Analysis:
We are undertaking a randomised controlled trial (commenced in March 2020) that will include 106 children (aged 4-18 years) recruited from respiratory clinics at Queensland Children's Hospital, Australia. Inclusion criteria are able to perform reliable spirometry and a parent/guardian who can complete questionnaire(s). Children (1:1 allocation) are randomised to clinical medical review with spirometry (intervention group) or without spirometry (control group) within strata of consultation status (new/review), and cough condition (present/absent). The primary outcome is change in clinical decision making. The secondary outcomes are change in PROM scores, opinions regarding spirometry and degree of diagnosis certainty. Intergroup differences of these outcomes will be determined by χ2 test or unpaired t-test (or Mann-Whitney if not normally distributed). Change in outcomes within the control group after review of spirometry will also be assessed by McNemar's test or paired t-test/Wilcoxon signed-rank test.
Ethics And Dissemination:
The Human Research Ethics Committee of the Queensland Children's Hospital approved the study. The trial results will be disseminated through conference presentations, teaching avenues and publications.
Trial Registration Number:
ACTRN12619001686190; Pre-results.
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