Patient and public involvement in randomised controlled trial design and implementation: a process evaluation of the Linking You to Support and Advice (LYSA) trial

cbnd
Thumbnail Image
Files
s40900-025-00746-8 (1).pdf(1.02 MB)
Published Version
40900_2025_746_MOESM1_ESM.png(303.84 KB)
Supplementary Material
Date
2025-07-03
Authors
Medved, Katarina
Johnston, Katie
Thomas, Sasna S.
Hegarty, Josephine
Casey, Gillian
Connolly, Roisin M.
Raigal, Laia
O’Connell, Kate
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central Ltd
Published Version
10.1186/s40900-025-00746-8
Research Projects
Organizational Units
Journal Issue
Abstract
Background: The implementation of Patient and Public Involvement (PPI) in randomised controlled clinical trials (RCT) is crucial for improving the relevance and quality of research. PPI entails active engagement of patients and the public in various stages of the research process. The processes for effectively implementing PPI in RCTs remain underexplored and heterogeneous. Methods: An explorative single case study of the Linking You to Support and Advice (LYSA) randomised controlled trial, NCT05035173, aims to evaluate the processes of implementation of PPI through different stages of the research cycle. Results: The development and review of the grant application resulted in a more patient focused study development. Furthermore, the review of surveys, questionnaires and patient facing study materials led to amendments mainly referring to the language used. PPI contributors helped to co-design the symptom management resources in partnership with the project team. Evaluation of the ePRO collection tool did not result in any further amendments. PPI contributors participated in the development of the study’s acronym and focus group discussion. As a direct result of PPI input further work and research was done in the area of metastatic breast cancer. PPI contributors participated in social media work, review and co-authorship of this paper. Conclusions: Implementation of PPI through different stages of RCT’s is effective. It highlighted the importance of PPI in improving the relevance and quality of research. While PPI offers numerous benefits, its implementation is not without challenges. Barriers such as resource and time constraints, and varying levels of stakeholder engagement pose a challenge to effective PPI integration.
Description
Keywords
Patient and Public Involvement (PPI) , Randomised controlled clinical trials (RCT)
Citation
Medved, K., Johnston, K., Thomas, S.S., Hegarty, J., Casey, G., Connolly, R.M., Raigal, L. and O’Connell, K., 2025. Patient and public involvement in randomised controlled trial design and implementation: a process evaluation of the linking you to support and advice (LYSA) trial. Research Involvement and Engagement, 11(1), pp.1-9. https://doi.org/10.1186/s40900-025-00746-8
Link to publisher’s version
URI
https://hdl.handle.net/10468/17716
Collections
Medicine - Journal Articles
Copyright
© 2025, the Author(s). Open Access. This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, 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 you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. 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-nc-nd/4.0/