The impact of patient involvement on participant opinions of information sheets

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.