Online randomised trials with children: A scoping review protocol

Introduction: This scoping review will determine how online, randomised trials with children are conducted. The objectives of the review are: (a) to determine what methods and tools have been used to create and conduct online trials with children and (b) to identify the gaps in the knowledge in this...

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Vydané v:HRB open research Ročník 5; s. 46
Hlavní autori: Lepage, Simone, Conway, Aislinn, Goodson, Noah, Wicks, Paul, Devane, Declan
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Ireland F1000 Research Limited 2022
F1000 Research Ltd
Predmet:
Decentralised
Digital
E-health
eng
Internet-based
Randomised trials
Study Protocol
Web-based
Internet-based
Young people
Web-based
Decentralised
Digital
E-health
Children
Randomised trials
ISSN:2515-4826, 2515-4826
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Shrnutí:Introduction: This scoping review will determine how online, randomised trials with children are conducted. The objectives of the review are: (a) to determine what methods and tools have been used to create and conduct online trials with children and (b) to identify the gaps in the knowledge in this field. Over the last decade, randomised trials employing online methods have gained traction. Decentralised methods lend themselves to certain types of trials and can offer advantages over traditional trial methods, potentially increasing participant reach and diversity and decreasing research waste.  However, decentralised trials that have all aspects of the trial exclusively online are not yet common, and those involving children even less so. This scoping review will describe and evaluate the methods used in these trials to understand how they may be effectively employed. Methods: Methods are informed by guidance from the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. The search strategy was developed in consultation with an information specialist for the following databases: MEDLINE, CENTRAL, CINAHL, and Embase. Grey literature searches will be completed with the consultation of experts in decentralised trials and digital health using internet searches and suitable trial registries. Once identified, included full-text studies’ references will be manually searched for any trials that may have been missed. We will include randomised and quasi-randomised trials conducted exclusively online with participants under the age of 18 published in English. We will not limit by country of conduct or date of publication. Data will be collected using a data charting tool and presented in text, graphical, and tabular formats. Ethics and Dissemination: Ethical approval is not needed since all data sources used are publicly available. The review will be available as a preprint before publication in an open-access, peer-reviewed journal.
Bibliografia:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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These authors contributed equally to this work
Competing interests: PW is an associate editor at the Journal of Medical Internet Research and is on the editorial advisory boards of The BMJ, BMC Medicine, The Patient, and Digital Biomarkers. PW is employed by Wicks Digital Health Ltd, which has received funding from Ada Health, AstraZeneca, Biogen, Bold Health, Camoni, Compass Pathways, Coronna, EIT, Endava, Happify, HealthUnlocked, Inbeeo, Kheiron Medical, Lindus Health, MedRhythms, PatientsLikeMe, Sano Genetics, Self Care Catalysts, The Learning Corp, The Wellcome Trust, THREAD Research, VeraSci, and Woebot. NG is an employee of THREAD, a decentralized platform provider. The remaining authors, SL, AC, DD, have no conflicts of interest to report.
These authors also contributed equally to this work
ISSN:2515-4826
2515-4826
DOI:10.12688/hrbopenres.13566.1