Online randomised trials with children: A scoping review protocol

Lepage, Simone; Conway, Aislinn; Goodson, Noah; Wicks, Paul; Devane, Declan

doi:10.1101/2022.04.15.22273742

Cited by 2 publications

(6 citation statements)

References 26 publications

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“…Following the search, all identified citations were imported into EndNote20 [20], the libraries were collated, and duplicates were removed. These titles and abstracts were uploaded into Covidence, a web-based software developed by the Cochrane group to streamline evidence synthesis reviews [21].…”

Section: Screening and Selecting Evidence Sourcesmentioning

confidence: 99%

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Online randomised trials with children: A scoping review

Lepage

Conway

Goodson³

et al. 2023

Preprint

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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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Section: Screening and Selecting Evidence Sourcesmentioning

confidence: 99%

“…The published protocol for this scoping review details our methodology [18]. The study is registered with Open Science Framework (OSF) at (https://doi.org/10.17605/OSF.IO/WHJXY) [19]. Ethical approval was not required as all included data sources are publicly available.…”

Section: Protocol Registration and Ethicsmentioning

confidence: 99%

Online randomised trials with children: A scoping review

Lepage

Conway

Goodson³

et al. 2023

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…The published protocol for this scoping review details our methodology [19]. The study is registered with Open Science Framework (OSF) at (https://doi.org/10.17605/OSF.IO/WHJXY) [20].…”

Section: Protocol Registration and Ethicsmentioning

confidence: 99%

“…A detailed description of how the search strategy was devised is outlined in the protocol [19]. The strategy was constructed by SL and modified and finalised by an information and knowledge translation specialist (AC).…”

Section: Search Strategiesmentioning

confidence: 99%

See 1 more Smart Citation

Online randomised trials with children: A scoping review

Lepage

Conway

Goodson³

et al. 2023

PLoS ONE

View full text Add to dashboard Cite

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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Online randomised trials with children: A scoping review protocol

Cited by 2 publications

References 26 publications

Online randomised trials with children: A scoping review

Online randomised trials with children: A scoping review

Online randomised trials with children: A scoping review

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