Clinical utility of elective paediatric flexible bronchoscopy and impact on the quality of life: protocol for a single-centre, single-blind, randomised controlled trial
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Published on: January 17, 2011
Rahul Thomas1,2, Julie M Marchant2,3, Vikas Goyal2,4
1Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, South Brisbane, Queensland, Australia rahul.thomas@health.qld.gov.au.
Insights
This study investigates the impact of early flexible bronchoscopy (FB) on children's quality of life and management. Results will inform best practices for pediatric respiratory care.
Area of Science:
- Pediatric Pulmonology
- Clinical Trials
- Respiratory Medicine
Background:
- Flexible bronchoscopy (FB) is a common procedure for pediatric respiratory conditions.
- There is a lack of randomized controlled trials (RCTs) evaluating the benefits of elective FB.
- Understanding FB's impact on quality of life (QoL) and management is crucial.
Purpose of the Study:
- To determine the effect of early FB on parent-proxy QoL scores in children.
- To assess changes in clinical management and patient-reported outcome measures (PROMs) following FB.
- To quantify the perceived benefits of elective FB from patient and physician perspectives.
Main Methods:
- A single-center, single-blind randomized controlled trial (RCT) involving 114 children under 18.
- Participants were randomized to either an early FB group (within 2 weeks) or a delayed FB group.
- Primary outcome: change in QoL scores; secondary outcomes: changes in management, PROMs, and adverse events.
Main Results:
- The study is ongoing, with results pending.
- The primary outcome is the difference in QoL change between early and delayed FB groups.
- Secondary outcomes include management changes, PROMs, and adverse events.
Conclusions:
- The study hypothesizes that early FB leads to accurate diagnosis and improved QoL.
- Findings will provide evidence on the benefits of elective FB in pediatric respiratory care.
- Results will guide clinical decision-making and optimize treatment strategies.
Introduction:
Elective flexible bronchoscopy (FB) is now widely available and standard practice for a variety of indications in children with respiratory conditions. However, there are no randomised controlled trials (RCTs) that have examined its benefits (or otherwise).Our primary aim is to determine the impact of FB on the parent-proxy quality-of-life (QoL) scores. Our secondary aims are to determine if undertaking FB leads to (a) change in management and (b) improvement of other relevant patient-reported outcome measures (PROMs). We also quantified the benefits of elective FB (using 10-point Likert scale). We hypothesised that undertaking elective FB will contribute to accurate diagnosis and therefore appropriate treatment, which will in turn improve QoL and will be deemed to be beneficial from patient and doctor perspectives.
Methods And Analysis:
Our parallel single-centre, single-blind RCT (commenced in May 2020) has a planned sample size of 114 children (aged <18 years) recruited from respiratory clinics at Queensland Children's Hospital, Brisbane, Australia. Children are randomised (1:1 concealed allocation) within two strata: age (≤2 vs >2 years) and indication for FB (chronic cough vs other indications) to either (a) early arm (intervention where FB undertaken within 2 weeks) or (b) delayed (control, FB undertaken at usual wait time). Our primary outcome is the difference between groups in their change in QoL at the T2 timepoint when the intervention group has had the FB and the control group has not. Our secondary outcomes are change in management, change in PROMs, adverse events and the Likert scales.
Ethics And Dissemination:
The human research ethics committee of the Queensland Children's Hospital granted ethical clearance (HREC/20/QCHQ/62394). Our RCT is conducted in accordance with Good Clinical Practice and the Australian legislation. Results will be disseminated through conference presentations, teaching avenues, workshops, websites and publications.
Registration:
Australia New Zealand Clinical Trial Registry ACTRN12620000610932.
