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Improved quality of reporting safety data of medication in paediatric randomised controlled trials
  1. Taco Jan Prins1,
  2. Corine Rollema2,
  3. Eric van Roon2,
  4. Tjalling de Vries1
  1. 1Paediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands
  2. 2Department of Clinical Pharmacy and Pharmacology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands
  1. Correspondence to Dr Tjalling de Vries, Paediatrics, Medical Centre Leeuwarden, Leeuwarden 8901 BR, The Netherlands;{at}


Objective Evaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.

Design Literature search with a systemic appraisal of adverse drug event reporting.

Main outcome measures Quality of reporting of safety data using Consolidated Standards of Reporting Trials (CONSORT) and Ioannidis scores in paediatric drug RCTs. The CONSORT score consists of nine recommendations of the CONSORT Group issued to improve the quality of reporting adverse events. The Ioannidis score is based on these advices. We considered a CONSORT score of at least 6 and an Ioannidis score of at least 3 as sufficient.

Results We reviewed 100 RCTs published in 2017 and 2018. Ninety-four (94%) articles mentioned adverse events compared with 78% in the earlier study. Fifty-seven per cent used a standardised method for reporting adverse events compared with 34% in our earlier study. In 26 of the articles, the expected adverse events were defined, and 27 articles had a preset standardised scale for adverse events. Of these, 62 articles (62%) had a CONSORT score of 6 or higher compared with 18% in 2010. In the present study, 67% had an Ioannidis score of 3 or higher, whereas in the earlier study this was 29%. Both differences are statistically significant (p<0.05).

Conclusions Reporting safety data in paediatric RCTs has improved over the past 10 years. However, there is still room for improvement and for further improvement. Authors and editors should give more attention to methods for collecting, reporting and presenting safety data of RCTs in studies and manuscripts.

  • health services research
  • statistics
  • pharmacology

Statistics from


  • Contributors TdV and EvR conducted the earlier study and had the idea for this study. All authors were involved in the design of this study. CR and TJP performed the literature search and scored the articles. All authors were involved in analysing the data and contributed to the writing of the article.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. All articles included are available from the appendix.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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