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Decision-making in acute viral bronchiolitis: A universal guideline and a publication gap
1Department of General Pediatrics and Pediatric Intensive Care, Center of Pediatric and Adolescent Medicine, University Hospital Heidelberg, Heidelberg, Germany.
Insights
A significant publication gap exists for acute viral bronchiolitis treatments, with many studies remaining unpublished. This gap may have influenced the American Academy of Pediatrics (AAP) guideline recommendations for pediatric respiratory illness.
Area of Science:
- Pediatrics
- Clinical Research
- Evidence-Based Medicine
Background:
- Acute viral bronchiolitis is a common pediatric respiratory illness requiring hospitalization for severe cases.
- The 2014 American Academy of Pediatrics (AAP) guideline for bronchiolitis is widely adopted globally.
- A potential publication bias in clinical medicine may affect such guidelines.
Purpose of the Study:
- To investigate the publication gap for clinical trials on acute viral bronchiolitis treatment.
- To assess the impact of the AAP guideline on study publication rates.
Main Methods:
- Analyzed studies registered on ClinicalTrials.gov marked as completed by October 2018.
- Searched major trial and literature databases for publications.
- Contacted study investigators directly to identify unpublished trials.
Main Results:
- Only 72% of 69 registered acute viral bronchiolitis trials were published by November 2019.
- Unpublished trials included data from 4,687 patients.
- Publication rates dropped from 80% before 2014 to 40% after the AAP guideline release.
Conclusions:
- A substantial publication bias affects acute viral bronchiolitis research.
- This bias may have influenced the AAP guideline's recommendations.
- The guideline itself might have inadvertently discouraged publication of post-release study findings.
Background:
Acute viral bronchiolitis is very common in infants and children up to 2 years. Some patients develop serious respiratory symptoms and need to be hospitalized. In 2014, the American Academy of Pediatrics (AAP) published a guideline on acute bronchiolitis which has gained global acceptance. We hypothesized that a publication gap, which is increasingly perceived in clinical medicine, might have also affected these universal recommendations.
Methods:
We determined the proportion of published and unpublished studies registered at ClinicalTrials.gov that were marked as completed by October 1st 2018. The major trial and literature databases were used to search for publications. In addition, the study investigators were contacted directly.
Results:
Of the 69 registered studies on the treatment of acute viral bronchiolitis, only 50 (72%) have been published by November 2019. Published trials contained data from n = 9403 patients, whereas n = 4687 patients were enrolled in unpublished trials. Median time to publication was 20 months, and only 8 of 50 trials were published within 12 months after completion. Only 40% of the clinical trials that were completed after the release of the AAP guideline were subsequently published as compared to 80% before 2014.
Conclusion:
There is a significant publication gap regarding therapy of acute viral bronchiolitis that may have influenced certain recommendations of the AAP guideline. In turn, recommendations of the guideline might have discouraged investigators to publish their results after its release.
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