Arundel, Catherine Ellen orcid.org/0000-0003-0512-4339, Clark, Laura Kate orcid.org/0000-0001-9227-5447, Coleman, Elizabeth orcid.org/0000-0003-4210-1865 et al. (3 more authors) (2022) Challenges and Solutions to the Implementation of Studies within a Trial:The Experiences of the PROMETHEUS Programme. Research Methods in Medicine & Health Sciences. ISSN 2632-0843
Abstract
Background Effective and efficient conduct of randomised controlled trials (RCTs) ensures accurate, timely results and prevents research waste. There is limited evidence however available to inform the design, conduct and reporting of RCTs. A self-contained, randomised Study Within A Trial (SWAT), embedded within a host RCT or cohort study, offers an opportunity to fill this evidence gap. While SWATs are generally easy to implement, a range of challenges to undertaking SWATs have also been identified, however there is limited detail regarding practical solutions to tackle these. Methods Information and observations collected from PROMETHEUS members and participating trials, focusing on SWATs across a wide range of questions and settings, was reviewed to identify the challenges and solutions of delivery of a programme of SWATs. Results A range of challenges to undertaking SWATs (e.g. obtaining governance approvals) were identified along with potential solutions to these, which were implemented accordingly during programme delivery. Central to the solutions to resolve SWAT challenges is education to develop knowledge and understanding in the wider research community on the importance, purpose, and key methodological principles in relation to SWATs. In addition, the sharing of experience, best practice or resources to prevent or help negotiate the barriers to undertaking SWAT evaluation is also recommended. Conclusions Potential solutions to the barriers experienced in the design, conduct and implementation of a programme of SWATs have been identified. As more SWATs are completed, this will further develop evidence to support the mitigation or removal of barriers and in doing so this should increase the efficiency of randomised controlled trials.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details |
Dates: |
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Institution: | The University of York |
Academic Units: | The University of York > Faculty of Sciences (York) > Health Sciences (York) |
Funding Information: | Funder Grant number MEDICAL RESEARCH COUNCIL (MRC) MR/R013748/1 |
Depositing User: | Pure (York) |
Date Deposited: | 18 May 2022 08:40 |
Last Modified: | 09 Mar 2025 00:08 |
Published Version: | https://doi.org/10.1177/26320843221106949 |
Status: | Published online |
Refereed: | Yes |
Identification Number: | 10.1177/26320843221106949 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:186830 |
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