Background Bronchiolitis exerts a high burden on children, their families and the healthcare system. The Canadian Bronchiolitis Epinephrine Steroid Trial (CanBEST) assessed whether administering epinephrine alone, dexamethasone alone, or in combination (EpiDex) could reduce bronchiolitis-related hospitalizations among children less than 12 months of age compared to placebo. CanBEST demonstrated a statistically significant reduction in 7-day hospitalization risk with EpiDex in an unadjusted analysis but not after adjustment.
Objective To explore the probability that EpiDex results in a reduction in hospitalizations using Bayesian methods.
Study Design Using prior distributions that represent varying levels of preexisting enthusiasm or skepticism and information about the treatment effect before data were collected, the Bayesian distribution of the relative risk of hospitalization compared to placebo was determined. The probability that the treatment effect is less 1, 0.9, 0.8 and 0.6, indicating increasing reductions in hospitalization risk, are computed alongside 95% credible intervals.
Results Combining a minimally informative prior distribution with the data from CanBEST provides comparable results to the original analysis. Unless strongly skeptical views about the effectiveness of EpiDex were considered, the 95% credible interval for the treatment effect lies below 1, indicating a reduction in hospitalizations. There is a 90% probability that EpiDex results in a clinically meaningful reduction in hospitalization of 10% even when incorporating skeptical views, with a 67% probability when considering strongly skeptical views.
Conclusion A Bayesian analysis demonstrates a high chance that EpiDex reduces hospitalization rates for bronchiolitis, although strongly skeptical individuals may require additional evidence to change practice.
Competing Interest StatementAmy C. Plint receives in-kind support from Amphastar for a clinical trial in bronchiolitis. The other authors have no relevant conflicts to disclose.
Clinical TrialCurrent Controlled Trials number, ISRCTN56745572
Clinical Protocolshttps://pubmed.ncbi.nlm.nih.gov/19439742/
Funding StatementYes
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Children's Hospital of Eastern Ontario Research Ethics Board gave approval in May 2004 for the CanBEST study with REB Number 02/59E.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
FootnotesSources of financial assistance: This work was supported by Canada Research Chairs in Statistical Trial Design [AH] and Clinical Trials [TPK] (https://www.chairs-chaires.gc.ca/home-accueil-eng.aspx), Tier 1 University of Ottawa Research Chair [ACP] (https://www.uottawa.ca/faculty-medicine/research-and-innovation/research-chairs) and an operating grant from Canadian Institutes of Health Research (CIHR; https://cihr-irsc.gc.ca/e/193.html) for the original CanBEST study. The funders plated no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Conflict of Interest Disclosures: Amy C. Plint receives in-kind support from Amphastar for a clinical trial in bronchiolitis. The other authors have no relevant conflicts to disclose.
Prior Presentations: This results from this analysis were presented at the Statistical Society of Canada Conference 2023.
Data Sharing Statement: Data cannot be shared publicly because participants of this study did not agree for their data to be shared publicly. Data are available from CHEO for researchers who meet the criteria for access to confidential data.
Clinical Trial registry name, registration number: Current Controlled Trials number, ISRCTN56745572
Research Ethics Approval: Children’s Hospital of Eastern Ontario Research Ethics Board gave approval in May 2004 for the CanBEST study with REB Number 02/59E.
Data AvailabilityData cannot be shared publicly because participants of this study did not agree for their data to be shared publicly. Data are available from CHEO for researchers who meet the criteria for access to confidential data.
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