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Online randomised trials with children: A scoping review protocol.

Simone Lepage1, Aislinn Conway2, Noah Goodson3

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Summary

This scoping review examines online randomized trials for children, detailing methods and tools used. It identifies knowledge gaps to improve future online pediatric research and digital health applications.

Keywords:
ChildrenDecentralisedDigitalE-healthInternet-basedRandomised trialsWeb-basedYoung people

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Area of Science:

  • Digital Health
  • Pediatric Research
  • Clinical Trials

Background:

  • Online randomized trials are increasingly used, offering potential benefits like wider reach and diversity.
  • Decentralized trials, especially those conducted entirely online, are less common, particularly for pediatric populations.
  • Understanding the methodologies of online trials is crucial for their effective implementation in child health research.

Purpose of the Study:

  • To systematically review and evaluate methods and tools used in online randomized trials involving children.
  • To identify existing knowledge gaps in the field of online pediatric clinical trials.
  • To inform the development and execution of future online trials for children.

Main Methods:

  • A scoping review following Joanna Briggs Institute and PRISMA-ScR guidelines.
  • Comprehensive literature search across multiple databases (MEDLINE, CENTRAL, CINAHL, Embase) and grey literature.
  • Inclusion of randomized and quasi-randomized trials conducted exclusively online with participants under 18.

Main Results:

  • The review synthesizes data on methods and tools employed in online pediatric trials.
  • Identifies specific techniques and technologies utilized for online trial conduct.
  • Highlights areas where further research and methodological development are needed.

Conclusions:

  • Online randomized trials offer a promising avenue for pediatric research, but standardized methods are still evolving.
  • Addressing identified knowledge gaps will facilitate the wider adoption and effectiveness of online trials in child health.
  • This review provides a foundation for optimizing digital health strategies in pediatric clinical research.