@article{a027df6f44a24a648e7535c769e097c5,
title = "The impact of patient involvement on participant opinions of information sheets",
abstract = "Background Patient and public involvement (PPI) groups can provide valuable input to create more accessible study documents with less jargon. However, we don't know whether this procedure improves accessibility for potential participants. Aims We assessed whether participant information sheets were rated as more accessible after PPI review and which aspects of information sheets and study design were important to mental health patients compared with a control group with no mental health service use. Method This was a double-blind quasi-experimental study using a mixed-methods explanatory design. Patients and control participants quantitatively rated pre- and post-review documents. Semi-structured interviews were thematically analysed to gain qualitative feedback on opinions of information sheets and studies. Two-way multivariate analysis of variance was used to detect differences in ratings between pre- and post-review documents. Results We found no significant (P < 0.05) improvements in patient (n = 15) or control group (n = 21) ratings after PPI review. Patients and controls both rated PPI as of low importance in studies and considered the study rationale as most important. However, PPI was often misunderstood, with participants believing that it meant lay patients would take over the design and administration of the study. Qualitative findings highlight the importance of clear, friendly and visually appealing information sheets. Conclusions Researchers should be aware of what participants want to know about so they can create information sheets addressing these priorities, for example, explaining why the research is necessary. PPI is poorly understood by the wider population and efforts must be made to increase diversity in participation.",
keywords = "accessibility, Consent and capacity, information sheets, patient and public involvement, readability",
author = "Georgie Hudson and Jansli, {Sonja M.} and Daniel Morris and Til Wykes and Sagar Jilka",
note = "Funding Information: This paper represents independent research funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London (IS-BRC-1215-20018). Funding Information: Participant information sheets need to be clear and jargon-free to achieve true informed consent. This can be facilitated by non-tokenistic patient and public involvement (PPI) when creating them. 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 to improve participant-facing documents such as participant information sheets. 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 of Health and Care Research (NIHR) Maudsley Biomedical Research Centre. The PPI review highlights potential stumbling blocks to ethical approval, for example, by ensuring clear and accessible language in participant-facing documents and including information needed for genuinely informed consent. The PPI group reviews documents and returns them within 7 working days. In a recent study, we found that reviewed documents contained less jargon and were preferred over the original versions in a blind test. PPI reviewers highlighted issues relating to document clarity, data protection, vocabulary, study design and presentation, and also raised issues that are overlooked by regulatory bodies. The US Food and Drug Administration recommend a readability grade of eight or lower (i.e. readable by someone aged 13 years.) However mental health study information rarely meets this recommended reading grade. It is therefore vital to understand how this lowered accessibility will affect potential research participants, including those who use mental health services and those who do not. This study builds upon our previous work to understand the impact of PPI by investigating diverse research-na{\"i}ve participants. Many such investigations have included participants who are not sufficiently ethnically diverse, so we specifically recruited an ethnically diverse group. We also investigated whether a lack of readability in information sheets was an issue for all potential participants or whether it was unique to mental health patients by comparing those with a mental health service history and people without (control participants). , Publisher Copyright: Copyright {\textcopyright} 2023 The Author(s).",
year = "2023",
month = jan,
day = "9",
doi = "10.1192/bjo.2022.627",
language = "English",
volume = "9",
journal = "BJPsych Open",
issn = "2056-4724",
publisher = "Cambridge University Press",
number = "1",
}
