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Paediatric updates for SPIRIT and CONSORT

Setting up and running large multicentre network, randomised clinical trials (RCTs) in child health is hard work, expensive and time-consuming. To run the study within a robust research governance structure is crucial to scientific credibility, usefulness of the results and conclusions of the study, and reduces research waste. Reporting your work accurately and in a comprehensive and transparent way requires a structure and standardisation. So far, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines are there for you to follow, but these are not child specific. Inadequate reporting continues to be a major challenge to dissemination. Paediatric-specific problems related to RCTs include: (a) omission of key features on trial interventions and outcome measurements in children across the age groups; (b) the description of ethnicity, race and various social determinants of health; (c) sample size and power calculations; and (d) describing consent and, most importantly, the assent process which is still often neglected completely. Baba et al (JAMA Pediatr 2024;178:111–112) have presented an eight-part plan to the development of child-specific reporting guidelines: …

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Footnotes

  • 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.

  • Provenance and peer review Commissioned; internally peer reviewed.