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How to make study documents clear and relevant : the impact of patient involvement

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Jilka, Sagar, Hudson, Georgie, Jansli, Sonja M., Negbenose, Esther, Wilson, Emma, Odoi, Clarissa M., Mutepua, Magano and Wykes, Til (2021) How to make study documents clear and relevant : the impact of patient involvement. BJPsych Open, 7 (6). e202. doi:10.1192/bjo.2021.1040 ISSN 2056-4724.

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Official URL: http://dx.doi.org/10.1192/bjo.2021.1040

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Abstract

Background
Patient and public involvement can improve study outcomes, but little data have been collected on why this might be. We investigated the impact of the Feasibility and Support to Timely Recruitment for Research (FAST-R) service, made up of trained patients and carers who review research documents at the beginning of the research pipeline.

Aims
To investigate the impact of the FAST-R service, and to provide researchers with guidelines to improve study documents.

Method
A mixed-methods design assessing changes and suggestions in documents submitted to the FAST-R service from 2011 to 2020. Quantitative measures were readability, word count, jargon words before and after review, the effects over time and if changes were implemented. We also asked eight reviewers to blindly select a pre- or post-review participant information sheet as their preferred version. Reviewers’ comments were analysed qualitatively via thematic analysis.

Results
After review, documents were longer and contained less jargon, but did not improve readability. Jargon and the number of suggested changes increased over time. Participant information sheets had the most suggested changes. Reviewers wanted clarity, better presentation and felt that documents lacked key information such as remuneration, risks involved and data management. Six out of eight reviewers preferred the post-review participant information sheet. FAST-R reviewers provided jargon words and phrases with alternatives for researchers to use.

Conclusions
Longer documents are acceptable if they are clear, with jargon explained or substituted. The highlighted barriers to true informed consent are not decreasing, although this study has suggestions for improving research document accessibility.

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Mental Health and Wellbeing
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Patients, Hospital patients -- Attitudes, Medical care surveys , Patient compliance
Journal or Publication Title: BJPsych Open
Publisher: Cambridge University Press
ISSN: 2056-4724
Official Date: November 2021
Dates:
DateEvent
November 2021Published
4 November 2021Available
8 October 2021Accepted
Volume: 7
Number: 6
Article Number: e202
DOI: 10.1192/bjo.2021.1040
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 4 November 2021
Date of first compliant Open Access: 8 November 2021
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
IS-BRC-1215-20018[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272

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