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.
Highlights
Patient and public involvement can improve study outcomes, but little data have been collected on why this might be
It is important for researchers to provide clear participant information sheets to have true informed consent,[1] 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.[2,3]
Summary
A mixed-methods design assessing changes and suggestions in documents submitted to the FAST-R service from 2011 to 2020. Reviewers’ comments were analysed qualitatively via thematic analysis This is a mixed-methods study auditing documents submitted to FAST-R before and after review, and investigating their accessibility (reading grade, jargon, length, etc.) by using quantitative analyses. All study documents were related to mental health research and consisted of a variety of study types and fields, such as clinical trials, cross-sectional investigations and qualitative studies (e.g. Martland et al,[16] Greer at al[17]) This was supplemented by a detailed qualitative analysis of patient/carer FAST-R member reviews found on the feedback forms and on the documents themselves. The authors selected the participant information sheets with at least 75% of changes implemented by the researcher These eight studies were reviewed by eight FAST-R reviewers who each considered one study they had not seen before, with no information on which document was pre- or postreview.
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