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Online randomised trials with children: A scoping review
Simone Lepage1,2, Aislinn Conway3, Noah Goodson4
1Health Research Board-Trials Methodology Research Network (HRB-TMRN), University of Galway, Galway, Ireland.
Plos One
|May 25, 2023
Summary
This review explored online-decentralised paediatric trials, finding social media effective for recruitment but highlighting a need for better reporting on methods and patient involvement to improve trial quality and reproducibility.
Area of Science:
- Clinical Trials
- Pediatric Research
- Digital Health
Background:
- Paediatric trials face unique challenges beyond those in adult studies.
- Decentralised trials offer a promising approach to address these obstacles.
- Online-decentralised trials are a specific strategy within this domain.
Purpose of the Study:
- To identify methods and tools used in fully online-decentralised paediatric trials.
- To determine existing knowledge gaps in this research area.
- To describe facilitators and challenges in conducting such trials.
Main Methods:
- A systematic scoping review guided by Joanna Briggs Institute and PRISMA extension.
- Searches across major databases (MEDLINE, CENTRAL, CINAHL, Embase), registries, and pre-print servers.
- Inclusion of randomized and quasi-randomized trials conducted entirely online for participants under 18.
Main Results:
- Twenty-one trials were included, with participants averaging 14.6 years.
- Social media was the primary recruitment channel; external websites hosted most data.
- Most trials had low risk of bias in certain areas but high risk in blinding and incomplete data; allocation concealment was often unclear.
Conclusions:
- Significant gaps exist in transparent reporting of recruitment, randomization, and retention methods.
- Patient and public involvement was infrequent and uncompensated.
- Improved reporting is crucial for enhancing the reproducibility and quality of online-decentralised paediatric trials.
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