Improved quality of reporting safety data of medication in paediatric randomised controlled trials
| Autor: | Eric N. van Roon, Corine Rollema, Tjalling W. de Vries, Taco Jan Prins |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Adolescent Drug-Related Side Effects and Adverse Reactions media_common.quotation_subject 03 medical and health sciences 0302 clinical medicine 030225 pediatrics Humans Medicine Quality (business) 030212 general & internal medicine Child Adverse effect Randomized Controlled Trials as Topic media_common business.industry Infant Newborn Outcome measures Health services research Infant Consolidated Standards of Reporting Trials Quality Improvement Data Accuracy Research Design Adverse drug event Child Preschool Pediatrics Perinatology and Child Health Physical therapy business |
| Zdroj: | Archives of Disease in Childhood. 106:1010-1014 |
| ISSN: | 1468-2044 0003-9888 |
| Popis: | ObjectiveEvaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.DesignLiterature search with a systemic appraisal of adverse drug event reporting.Main outcome measuresQuality 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.ResultsWe 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 (pConclusionsReporting 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. |
| Databáze: | OpenAIRE |
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