By the same authors

From the same journal

Inadequate harms reporting in randomized control trials of antibiotics for pediatric acute otitis media: a systematic review

Research output: Contribution to journalReview articlepeer-review

Full text download(s)

Published copy (DOI)



Publication details

DateE-pub ahead of print - 8 May 2018
Issue number10
Number of pages6
Pages (from-to)933-938
Original languageEnglish


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.

Bibliographical note

© Springer International Publishing AG, part of Springer Nature 2018. This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details.

Discover related content

Find related publications, people, projects, datasets and more using interactive charts.

View graph of relations