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Inadequate harms reporting in randomized control trials of antibiotics for pediatric acute otitis media: a systematic
Stephanie W Hum1, Su Golder2, Nader Shaikh3,4
1University of Pittsburgh School of Medicine, 3550 Terrace St, Pittsburgh, PA, 15213, USA.
Introduction:
Reporting of harms in randomized control trials is often inconsistent and inadequate.
Objective:
To assess the quality of harms reporting in randomized control trials evaluating the efficacy of antibiotics used to treat pediatric acute otitis media and to investigate whether connections to pharmaceutical companies or the publication of the CONSORT-Harms extension influenced the quality of harms reporting.
Study Design And Setting:
We considered randomized control trials that evaluated the efficacy and safety of antibiotic treatment for uncomplicated acute otitis media in children aged 0-19. We evaluated the quality of harms reporting using a 19-item checklist addressing the recommendations endorsed in the CONSORT-Harms extension.
Results:
160 studies met our inclusion criteria. Overall quality of reporting relating to harms was low; on average studies adhered to 55.2% of the checklist items on the quality of harms reporting. The reporting of methods relating the measurement of harms was particularly lacking; studies adhered to an average of only 33.2% of the checklist items. The overall quality of reporting did not change after the publication of the CONSORT-Harms extension. The overall quality of reporting did not differ significantly in reports with or without declared connections to pharmaceutical companies (mean quality score of 56.8% vs 52.0%, respectively).
Conclusions:
Harms reporting in pediatric randomized trials, especially the reporting of methods used to collect harms data, remains inadequate.
Insights
Harms reporting in pediatric antibiotic trials is poor, particularly regarding data collection methods. This inadequate reporting did not improve after the CONSORT-Harms extension or differ based on industry funding.
Area of Science:
- Pediatric clinical trials
- Antibiotic efficacy and safety research
- Medical research reporting standards
Background:
- Inconsistent and inadequate reporting of harms is a common issue in randomized control trials.
- Ensuring comprehensive harms reporting is crucial for patient safety and evidence-based medicine.
Purpose of the Study:
- To evaluate the quality of harms reporting in randomized control trials for pediatric acute otitis media treated with antibiotics.
- To determine if pharmaceutical company connections or the CONSORT-Harms extension publication impacted reporting quality.
Main Methods:
- Systematic review of 160 randomized control trials on antibiotic treatment for pediatric acute otitis media.
- Assessment of harms reporting quality using a 19-item checklist based on the CONSORT-Harms extension.
Main Results:
- Overall harms reporting quality was low, with studies meeting only 55.2% of checklist items.
- Reporting of methods for measuring harms was particularly deficient (33.2% adherence).
- No significant improvement in reporting quality was observed post-CONSORT-Harms publication or in trials with industry connections.
Conclusions:
- Harms reporting in pediatric randomized trials, especially methods for harms data collection, remains inadequate.
- Current reporting standards and guidelines may not be sufficiently effective in improving harms reporting quality.
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