<i>DigiKnowIt News</i>: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

Parker, Alison E; Scull, Tracy M.; Morrison, Abigail M

doi:10.1177/13674935211003774

Cited by 3 publications

(12 citation statements)

References 50 publications

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“…Eight trials combined their online recruitment with offline advertising of the trial [28-29, 33-34, 38-39, 42, 45]. Offline recruitment included advertisements in communities, through healthcare professionals, and schools.…”

Section: Resultsmentioning

confidence: 99%

“…All included trials reported acquiring consent from participants. Parental/caregiver consent was required in twelve of the trials [29-30, 34-35, 37-40, 42-45], waived in five of them [31, 33, 41, 46-47] and not reported in four [27-28, 32, 36]. Ten trials validated participants’ consent via attention-check questions, quality-check questions, ongoing consent, and orientation videos [29-31, 34, 37, 39, 41-42, 45, 47].…”

Section: Resultsmentioning

confidence: 99%

“…Seven trials [27, 29, 31-33, 36, 38] sent links to their participants via email or a direct social media message to direct them to an e-consent form. Five trials [40-42, 45-46] used an external website (e.g., Qualtrics, REDCap, IRIS) that hosted their e-consent. Participants were automatically redirected through a click-link to an external website for the consent process.…”

Section: Resultsmentioning

confidence: 99%

“…Bragg et al [29] was a single-session intervention with no follow-up data requirements conducted with 832 participants, offered no compensation, but reported the lowest loss to follow-up (reported as 6.5% across combined intervention and comparator arms). Thirteen trials sent reminders to participants [28, 32-33, 37-38, 40-43, 45-46] for enrolment, retention, or follow-up data collection.…”

Section: Resultsmentioning

confidence: 99%

“…Automated re-direction links to external websites were the second most common method. Ten trials [29-31, 34, 37, 39, 41-42, 45, 47] in our review created consent validation checks demonstrating creative and varied methods to increase their participants’ comprehension of the trial.…”

Section: Discussionmentioning

confidence: 99%

See 4 more Smart Citations

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: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Online randomised trials with children: A scoping review

Lepage

Conway

Goodson³

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

Efficacy of DigiKnowItNews: Teen, a multimedia educational website for adolescents about pediatric clinical trials: study protocol for a randomized controlled trial

Parker

Scull

Kennedy

2023

Trials

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Background Pediatric research is crucial for the development of new scientific advancements, treatments, and therapies for adolescents. Yet relatively few pediatric clinical trials are conducted due to barriers to successful recruitment and retention, including knowledge and attitudes about clinical trials. Adolescents tend to experience greater autonomy to make decisions and have expressed interest in being part of the decision to participate in clinical trials. Increasing knowledge, positive attitudes, and self-efficacy related to clinical trials could positively impact the decision to participate in a pediatric clinical trial. However, there are currently few interactive, developmentally appropriate, web-based resources available to educate adolescents about clinical trials. DigiKnowItNews: Teen was created as a multimedia educational website to address the relatively low levels of enrollment in pediatric clinical trials and need for information to empower adolescents to make decisions about participating in clinical trials. Methods This is a parallel group randomized controlled superiority trial to test the effectiveness of DigiKnowItNews: Teen, for improving factors related to clinical trial participation among adolescent and parents. Eligible parent-adolescent (ages 12 to 17 years) pairs will be randomly assigned to one of two conditions: intervention or wait-list control. All participants will complete pre- and post-test questionnaires and participants assigned to the intervention will receive access to review the DigiKnowItNews: Teen content for 1 week. Wait-list control participants will have the option to review DigiKnowItNews: Teen after study completion. The primary outcomes are knowledge about clinical research, attitudes, and beliefs toward pediatric clinical trials, self-efficacy for making decisions related to clinical trial participation, willingness to participate in a future clinical trial, procedural fears, and parent-adolescent communication quality. Overall feedback and satisfaction related to DigiKnowItNews: Teen will also be collected. Discussion The trial will evaluate the effectiveness of DigiKnowIt News: Teen, an educational website about pediatric clinical trials for adolescents. If found effective in promoting factors related to future pediatric clinical trial participation, DigiKnowIt News: Teen could be used by adolescents, along with their parents, as they make the decision to participate in a clinical trial. Clinical trial researchers can also use DigiKnowIt News: Teen to aid their participant recruitment efforts. Trial registration ClinicalTrials.gov NCT05714943. Registered on 02/03/2023.

show abstract

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.

show abstract

DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

Cited by 3 publications

References 50 publications

Online randomised trials with children: A scoping review

Online randomised trials with children: A scoping review

Efficacy of DigiKnowItNews: Teen, a multimedia educational website for adolescents about pediatric clinical trials: study protocol for a randomized controlled trial

Online randomised trials with children: A scoping review

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