For instance, recent reports have referred to tokenism,28 29 or highlighted the potential challenges in identifying suitable individuals who are impartial and selleck chem Cabozantinib able to understand research methodologies, retain an interest, and commit long-term;15 17–19 30 of researchers having little experience of PPI and being uncertain about what to expect;15

18 31 and of jargon-related problems.19 32 33 INVOLVE suggest that PPI contributors would benefit from a ‘glossary of technical terms’,17 again something reflected in the suggestions from contributors within our study. Staley4 refers to the challenge of ensuring that involvement is meaningful and not simply tokenistic. Findings from the EPIC project regarding PPI training needs suggest that while informants were broadly receptive to PPI training for researchers, there was considerable reluctance regarding the training of PPI contributors, with a preference for ‘informal inductions’. The health services researchers in a previous qualitative interview study varied in how they interpreted PPI policy and in their PPI ‘working practices’ and referred to how PPI brought a ‘fear of the unknown’.31 This study also points to a ‘know-do’ gap, whereby researchers’ talk of the importance and value of PPI in the ‘ideal’ world stood in contrast to their experiences of ‘the reality’ of implementing PPI in practice.29 The timing of involvement has been recently highlighted3 20 and is clearly

an ongoing challenge which is exacerbated by financial and time constraints8 32 particularly during the grant-writing stage. Study limitations We used a historical cohort of trials that had been funded 4–8 years ago. Even in that short time the emphasis on PPI has grown and our findings may not reflect the planning and implementation of PPI in trials funded more recently. Some of the trials in our sample were also initiated and completed some time before the interviews. However, this limitation is offset somewhat by the inclusion of ongoing trials in which PPI activity was recent and therefore easier to recollect. There were five trials for which it was

not possible to determine whether all documented PPI Brefeldin_A plans had been fully implemented or not. In some cases informants clearly struggled to recall events for trials which had ended several years previously or where researchers were involved in a number of trials simultaneously. We explored with informants how PPI contributors were involved in the trials but did not directly quiz CIs about why certain plans within their application were not implemented. This was intentional as we did not want to pose questions which may have seemed accusatory and have a detrimental impact on the rapport between informant and interviewer or risk informants becoming defensive. While some trialists seem to have expanded on their plans for PPI once the trial was underway there may, conversely, have been instances in which plans were not fully documented within the grant application.