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
(2020) In Trials 21(1).- Abstract
Background: Despite 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). Method: We 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... (More)
Background: Despite 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). Method: We 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. Results: Data 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. Conclusion: An 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 registration: The ORBIT trial is registered with ISRTCN (ISRCTN70758207) Registered on March 20, 2018. and ClinicalTrials.gov (NCT03483493). Registered on March 30, 2018.
(Less)
- author
- publishing date
- 2020-12
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Chronic tic disorder, Internet, Online, Randomised controlled trials, Recruitment, Research design, Retention, Tourette syndrome
- in
- Trials
- volume
- 21
- issue
- 1
- article number
- 1011
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:33298127
- scopus:85097407954
- ISSN
- 1745-6215
- DOI
- 10.1186/s13063-020-04902-1
- language
- English
- LU publication?
- no
- additional info
- Publisher Copyright: © 2020, The Author(s).
- id
- b77a8242-2f11-4ad6-a141-ed8d6732360f
- date added to LUP
- 2023-07-14 11:37:50
- date last changed
- 2024-04-19 23:29:37
@article{b77a8242-2f11-4ad6-a141-ed8d6732360f,
abstract = {{<p>Background: Despite 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). Method: We 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. Results: Data 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. Conclusion: An 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 registration: The ORBIT trial is registered with ISRTCN (ISRCTN70758207) Registered on March 20, 2018. and ClinicalTrials.gov (NCT03483493). Registered on March 30, 2018.</p>}},
author = {{Hall, Charlotte L. and Sanderson, Charlotte and Brown, Beverly J. and Andrén, Per and Bennett, Sophie and Chamberlain, Liam R. and Davies, E. Bethan and Khan, Kareem and Kouzoupi, Natalie and Mataix-Cols, David and McKenzie, Caitlin and Murphy, Tara and Townsend, Mark and Hollis, Chris and Murray, Elizabeth}},
issn = {{1745-6215}},
keywords = {{Chronic tic disorder; Internet; Online; Randomised controlled trials; Recruitment; Research design; Retention; Tourette syndrome}},
language = {{eng}},
number = {{1}},
publisher = {{BioMed Central (BMC)}},
series = {{Trials}},
title = {{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}},
url = {{http://dx.doi.org/10.1186/s13063-020-04902-1}},
doi = {{10.1186/s13063-020-04902-1}},
volume = {{21}},
year = {{2020}},
}