@article{c1068f63f1ee434e97865e093af5df2c,
title = "How to make study documents clear and relevant: The impact of patient involvement",
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.",
keywords = "accessibility, information sheets, jargon, Patient and public involvement, readability",
author = "Sagar Jilka and Georgie Hudson and Jansli, {Sonja M.} and Esther Negbenose and Emma Wilson and Odoi, {Clarissa M.} and Magano Mutepua and Til Wykes",
note = "Funding Information: This paper represents independent research funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London (grant IS-BRC-1215-20018). Funding Information: It is important for researchers to provide clear participant information sheets to have true informed consent, and one way to achieve this is through patient and public involvement. Patient and public involvement is required for UK publicly funded health research, with researchers describing their involvement strategy. Patient and public involvement is defined as {\textquoteleft}research carried out with or by members of the public rather than to, about or for them{\textquoteright}, where the public, patients and carers are active partners in research. Traditional research models often confine patients to the end of the research {\textquoteleft}pipeline{\textquoteright}, but ensuring collaboration across all stages can improve study outcomes, identify appropriate research questions and reduce {\textquoteleft}research waste{\textquoteright}. The Feasibility and Support to Timely Recruitment for Research (FAST-R; https://www.maudsleybrc.nihr.ac.uk/patients-public/support-for-researchers/ ) service offers access to trained mental health patients and carers for improving participant facing documents. This service was set up by the Mental Health Research Network in London in 2011, and is now organised and funded by the National Institute for Health Research (NIHR) Maudsley Biomedical Research Centre. FAST-R is used in the early stages of the research cycle, before seeking funds or ethical approval. The service can speed up these processes by highlighting potential stumbling blocks; for example, by ensuring clear and accessible language in participant-facing documents and including information needed for genuinely informed consent. Documents are considered by a group of reviewers with a facilitator, and are returned within 7 working days. Patient involvement has been contested despite the supports for co-production, so it is essential to understand whether there is an impact. Several potential measures are unexplored that affect whether someone has informed consent, such as readability and jargon. The US Food and Drug Administration (FDA) recommend a readability grade of eight or lower (i.e. readable by someone aged 13 years). These quantitative measures do not tell the whole story, as valuable comments on the ways patient and public involvement benefits a study can be missed. Therefore, in addition to quantitative measures, we explored FAST-R members{\textquoteright} views in detail, using qualitative methods. , – , , Publisher Copyright: Copyright {\textcopyright} 2021 The Author(s). Published by Cambridge University Press on behalf of the Royal College of Psychiatrists.",
year = "2021",
month = nov,
day = "4",
doi = "10.1192/bjo.2021.1040",
language = "English",
volume = "7",
journal = "BJPsych Open",
issn = "2056-4724",
publisher = "Cambridge University Press",
number = "6",
}
