Cargando…
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
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 heal...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724811/ https://www.ncbi.nlm.nih.gov/pubmed/33298127 http://dx.doi.org/10.1186/s13063-020-04902-1 |
_version_ | 1783620593637130240 |
---|---|
author | Hall, Charlotte L. Sanderson, Charlotte Brown, Beverly J. Andrén, Per Bennett, Sophie Chamberlain, Liam R. Davies, E. Bethan Khan, Kareem Kouzoupi, Natalie Mataix-Cols, David McKenzie, Caitlin Murphy, Tara Townsend, Mark Hollis, Chris Murray, Elizabeth |
author_facet | Hall, Charlotte L. Sanderson, Charlotte Brown, Beverly J. Andrén, Per Bennett, Sophie Chamberlain, Liam R. Davies, E. Bethan Khan, Kareem Kouzoupi, Natalie Mataix-Cols, David McKenzie, Caitlin Murphy, Tara Townsend, Mark Hollis, Chris Murray, Elizabeth |
author_sort | Hall, Charlotte L. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7724811 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-77248112020-12-09 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 Hall, Charlotte L. Sanderson, Charlotte Brown, Beverly J. Andrén, Per Bennett, Sophie Chamberlain, Liam R. Davies, E. Bethan Khan, Kareem Kouzoupi, Natalie Mataix-Cols, David McKenzie, Caitlin Murphy, Tara Townsend, Mark Hollis, Chris Murray, Elizabeth Trials Research 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. BioMed Central 2020-12-09 /pmc/articles/PMC7724811/ /pubmed/33298127 http://dx.doi.org/10.1186/s13063-020-04902-1 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Hall, Charlotte L. Sanderson, Charlotte Brown, Beverly J. Andrén, Per Bennett, Sophie Chamberlain, Liam R. Davies, E. Bethan Khan, Kareem Kouzoupi, Natalie Mataix-Cols, David McKenzie, Caitlin Murphy, Tara Townsend, Mark Hollis, Chris Murray, Elizabeth 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724811/ https://www.ncbi.nlm.nih.gov/pubmed/33298127 http://dx.doi.org/10.1186/s13063-020-04902-1 |
work_keys_str_mv | AT hallcharlottel opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT sandersoncharlotte opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT brownbeverlyj opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT andrenper opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT bennettsophie opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT chamberlainliamr opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT daviesebethan opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT khankareem opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT kouzoupinatalie opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT mataixcolsdavid opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT mckenziecaitlin opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT murphytara opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT townsendmark opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT hollischris opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople AT murrayelizabeth opportunitiesandchallengesofdeliveringdigitalclinicaltrialslessonslearnedfromarandomisedcontrolledtrialofanonlinebehaviouralinterventionforchildrenandyoungpeople |