Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial

Annabelle South; Nalinie Joharatnam-Hogan; Cara Purvis; Elizabeth C. James; Carlos Diaz-Montana; William J. Cragg; Conor Tweed; Archie Macnair; Matthew R. Sydes; Claire Snowdon; Katie Gillies; Talia Isaacs; Barbara E. Bierer; Andrew J. Copas

doi:10.1371/journal.pmed.1003798

Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial

Annabelle South, Nalinie Joharatnam-Hogan, Cara Purvis, Elizabeth C. James, Carlos Diaz-Montana, William J. Cragg, Conor Tweed, Archie Macnair, Matthew R. Sydes, Claire Snowdon, Katie Gillies, Talia Isaacs, Barbara E. Bierer, Andrew J. Copas

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Abstract

In this mixed methods trial, Annabelle South and colleagues investigate different approaches to sharing the results of a clinical trial with its participants.

Original language	English
Article number	e1003798
Number of pages	26
Journal	PLoS Medicine
Volume	18
Issue number	10
Early online date	4 Oct 2021
DOIs	https://doi.org/10.1371/journal.pmed.1003798
Publication status	Published - Oct 2021

Bibliographical note

Funding: The Show RESPECT study was funded by the Medical Research Council through core grants to MRS at the MRC CTU at UCL for Trial Conduct Methodology (MC_UU12023/24 and MC_UU_00004/08) https://mrc.ukri.org/. The funder had no role in the study design, the collection, analysis and interpretation of data, the writing of the report and the decision to submit the article for publication. All authors had full access to the study data, including statistical reports and tables, and can take responsibility for the integrity of the data and the accuracy of the data analysis.

Acknowledgments
We are very thankful to the patients who participated in this study and the people who contributed to our Patient and Public Involvement activities. We are very grateful for the work of the Show RESPECT site teams in carrying out this study. A list of team members from sites can be found in S10 Table. We thank Eva Burnett, who is a patient representative on the Study Steering Group for Show RESPECT and ICON8, for her input on the design and conduct of this study and for her comments on this manuscript, and Amanda Hunn for her contributions to the steering group. We also acknowledge the hard work and diligence of Sierra Santana and Ania Spurdens, who were data managers for Show RESPECT. We also wish to thank the ICON8 trial team for their support of this project, particularly Andrew Clamp, Babasola Popoola, Francesca Schiavone, Jonathan Badrock, and Rick Kaplan. We also thank Julia Bailey for her advice and guidance on the qualitative aspect of this study.

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10.1371/journal.pmed.1003798Licence: CC BY

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© 2021 South et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. https://creativecommons.org/licenses/by/4.0/
Final published version, 1.24 MBLicence: CC BY

Cite this

South, A., Joharatnam-Hogan, N., Purvis, C., James, E. C., Diaz-Montana, C., Cragg, W. J., Tweed, C., Macnair, A., Sydes, M. R., Snowdon, C., Gillies, K., Isaacs, T., Bierer, B. E., & Copas, A. J. (2021). Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial. PLoS Medicine, 18(10), [e1003798]. https://doi.org/10.1371/journal.pmed.1003798

South, A, Joharatnam-Hogan, N, Purvis, C, James, EC, Diaz-Montana, C, Cragg, WJ, Tweed, C, Macnair, A, Sydes, MR, Snowdon, C, Gillies, K, Isaacs, T, Bierer, BE & Copas, AJ 2021, 'Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial', PLoS Medicine, vol. 18, no. 10, e1003798. https://doi.org/10.1371/journal.pmed.1003798

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abstract = "In this mixed methods trial, Annabelle South and colleagues investigate different approaches to sharing the results of a clinical trial with its participants.",

author = "Annabelle South and Nalinie Joharatnam-Hogan and Cara Purvis and James, {Elizabeth C.} and Carlos Diaz-Montana and Cragg, {William J.} and Conor Tweed and Archie Macnair and Sydes, {Matthew R.} and Claire Snowdon and Katie Gillies and Talia Isaacs and Bierer, {Barbara E.} and Copas, {Andrew J.}",

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AU - Sydes, Matthew R.

AU - Snowdon, Claire

AU - Gillies, Katie

AU - Isaacs, Talia

AU - Bierer, Barbara E.

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Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial

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