ArticleTrials2020
Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03483493 (Therapist-guided, Parent-assisted Remote Digital Behavioural Intervention for Tics in Children and Adolescents With Tourette Syndrome), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Therapist-guided, Parent-assisted Remote Digital Behavioural Intervention for Tics in Children and Adolescents With Tourette Syndrome: an Internal Pilot Study and Single-blind Randomised Controlled Trial
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Digitally enabled therapy for chronic tic disorders and Tourette Syndrome: a systematic review and economic evaluation.Health technology assessment (Winchester, England) · 2026Pooled it
- Recommendations to promote equity, diversity and inclusion in decentralized clinical trials.Nature medicine · 2024Guideline
- Engagement With and Acceptability of Digital Media Platforms for Use in Improving Health Behaviors Among Vulnerable Families: Systematic Review.Journal of medical Internet research · 2023Pooled it
- A protocol paper for a pilot randomized controlled trial assessing the feasibility and acceptability of group medical visits for anxiety and depression in adults.Pilot and feasibility studies · 2026Article
- Digital tools for recruitment and retention of participants in paediatric clinical research: a scoping review.Trials · 2026Article
- An assessment of the informativeness of clinical trials in digital mental health.Npj mental health research · 2025Article
- Wellbeing for staff in UKCRC-registered Clinical Trials Units: Development of the Flourishing As Clinical Trial Staff (FACTS) guidance: a mixed-methods study.Contemporary clinical trials communications · 2025Article
- Enrollment and Retention Outcomes from the Veterans Health Administration for a Remote Digital Health Study: Multisite Observational Study.JMIR formative research · 2025Observational
- Development, Acceptability and Engagement with the Mind Tutor: Lessons Learned from Testing a Novel Digital Application for First Year UK Undergraduate Student Wellbeing.Psychological studies · 2025Article
- Designing and developing a prescription digital therapeutic for at-home heart rate variability biofeedback to support and enhance patient outcomes in post-traumatic stress disorder treatment.Frontiers in digital health · 2025Article
- Strategies to improve recruitment in mental health clinical trials: a scoping review (RE-MIND study).Trials · 2024Article
- Recruitment of Adolescents to Virtual Clinical Trials: Recruitment Results From the Health4Me Randomized Controlled Trial.JMIR pediatrics and parenting · 2024Article
- Flourishing and job satisfaction in employees working in UK clinical trial units: a national cross-sectional survey.BMC health services research · 2024Article
- Research Into Digital Health Intervention for Mental Health: 25-Year Retrospective on the Ethical and Legal Challenges.Journal of medical Internet research · 2024Article
- Widening participation - recruitment methods in mental health randomised controlled trials: a qualitative study.BMC medical research methodology · 2023Article
- Pediatric subspecialty healthcare providers' views of recruitment during a randomized controlled trial of a mobile health intervention.Contemporary clinical trials communications · 2023Article
- Treatment failure in persistent tic disorders: an expert clinicians' consensus-based definition.European child & adolescent psychiatry · 2023Article
- A qualitative exploration of advantages and disadvantages to using technology in the process of randomised controlled trial recruitment.HRB open research · 2023Article
- Article
- A Pilot Study to Examine the Feasibility and Acceptability of a Virtual Adaptation of an In-Person Adolescent Diabetes Prevention Program.International journal of environmental research and public health · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 5 institutions in 2 countries.
Funding
Abstract
backgroundDespite being the gold standard of research to determine effectiveness, randomised controlled trials (RCTs) often struggle with participant recruitment, engagement and retention. These issues may be exacerbated when recruiting vulnerable populations, such as participants with mental health issues. We aimed to update understanding of the scope of these problems in trials of health technology and identify possible solutions through reflecting on experiences from an exemplar trial (Online Remote Behavioural Intervention for Tics; ORBIT).
methodWe extracted anonymised data on recruitment, retention and requests for more funding and time from trials funded by the largest funder of health technology trials in the UK (the National Institute of Health Research Health Technology Assessment) between 2010 and 2020, and compared these with data from a recent, successful trial (ORBIT). ORBIT aimed to assess the clinical- and cost-effectiveness of blended online and human behavioural therapy for tics in young people. Many of the trial procedures, including recruitment, the intervention and data collection, were undertaken online.
resultsData were extracted on 51 trials conducted between 2010 and 2020. Sixty per cent of trials failed to reach their original recruitment target and only 44% achieved their follow-up in the specified time frame. In contrast, ORBIT recruited to target and achieved 90% follow-up. We posit that these achievements are related to (a) judicious use of digital technology for trial procedures and (b) adequate numbers of highly trained and motivated trial staff. We provide details of both these to help other research teams plan and cost for successful trials.
conclusionAn approach combining human and online methods may be advantageous in facilitating trial delivery, particularly in paediatric mental health services. Given the importance of successful clinical trials in advancing healthcare delivery and the waste of human and economic resources associated with unsuccessfully delivered trials, it is imperative that trials are appropriately costed and future research focusses on improving trial design and delivery.
trial registrationThe ORBIT trial is registered with ISRTCN ( ISRCTN70758207 ) Registered on March 20, 2018. and ClinicalTrials.gov ( NCT03483493 ). Registered on March 30, 2018.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.