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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.
Insights
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.
Background:
Paediatric trials must contend with many challenges that adult trials face but often bring additional obstacles. Decentralised trials, where some or all trial methods occur away from a centralised location, are a promising strategy to help meet these challenges. This scoping review aims to (a) identify what methods and tools have been used to create and conduct entirely online-decentralised trials with children and (b) determine the gaps in the knowledge in this field. This review will describe the methods used in these trials to identify their facilitators and the gaps in the knowledge.
Methods:
The methods were informed by guidance from the Joanna Briggs Institute and the PRISMA extension for scoping reviews. We systematically searched MEDLINE, CENTRAL, CINAHL, and Embase databases, trial registries, pre-print servers, and the internet. We included randomised and quasi-randomised trials conducted entirely online with participants under 18 published in English. A risk of bias assessment was completed for all included studies.
Results:
Twenty-one trials met our inclusion criteria. The average age of participants was 14.6 years. Social media was the most common method of online recruitment. Most trials employed an external host website to store and protect their data. Duration of trials ranged from single-session interventions up to ten weeks. Fourteen trials compensated participants. Eight trials involved children in their trial design process; none reported compensation for this. Most trials had a low risk of bias in "random sequence generation", "selective reporting", and "other". Most trials had a high risk of bias in "blinding participants and personnel", "blinding of outcome assessment", and "incomplete outcome data". "Allocation concealment" was unclear in most studies.
Conclusions:
There was a lack of transparent reporting of the recruitment, randomisation, and retention methods used in many of the trials included in this review. Patient and public involvement (PPI) was not common, and the compensation of PPI partners was not reported in any study. Consent methods and protection against fraudulent entries to trials were creative and thoroughly discussed by some trials and not addressed by others. More work and thorough reporting of how these trials are conducted is needed to increase their reproducibility and quality.
Ethics And Dissemination:
Ethical approval was not necessary since all data sources used are publicly available.
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