As well indicating the need for structures and resources to support PPI, our findings point to the importance of PPI that is fit for purpose, realistic and proportionate. We found that trialists who fully implemented a primarily oversight

mode of PPI perceived little value in this involvement—a related article Paclitaxel human endothelial cells from our study will fully explore the perceived impact of PPI in this cohort. While oversight PPI seemed limited in terms of its practical impact, arguably it may serve important ethical and moral functions. However, in order to avoid inadvertently promoting PPI that is devoid of any function for researchers and contributors, as we note above, funders should take full account of any PPI which has taken place prior to funding applications as well as encourage applicants to justify future plans for involvement. The NIHR HTA programme states: “While patient and public involvement (PPI) may not always be needed for all types of research, it is always relevant for HTA trials.” http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/77160/Preparing-a-full-application-for-the-Clinical-Trials-and-Evaluation-Board.pdf

(last accessed 9 March 2014). Even if there is consensus that PPI is relevant for all trials, it may not be relevant at all stages of all trials. Equally, funders may wish to contemplate how ‘contingency’ resources could be made available for those trials that encounter unexpectedly intense needs for PPI over the course of their implementation. Our findings add fuel to recent drives and initiatives to promote the assessment and reporting of PPI processes6 28 30 http://www.journalslibrary.nihr.ac.uk/authors/report-preparation/report-contents/14 including the GRIPP checklist.41 The CONSORT (Consolidated Standards of Reporting Trials) Statement, which was established specifically to encourage adequate reporting of RCTs, does not cover PPI. We suggest that consideration be given to incorporating advice on reporting of PPI in the main CONSORT checklist, so that reference to PPI is incorporated within the

main reports of trials, alongside separate detailed reports on PPI, Entinostat in line with the GRIPP checklist. If, in planning their PPI, trialists are prepared to consider and report its outcomes not only in terms of what happened and how, but also how this matched the needs of the trial, whether any complications arose or adaptations were made, and what lessons were learnt, then the evidence base will grow and the research community as a whole can learn. The EPIC project has highlighted the value of listening to the accounts of PPI contributors as well as researchers, and this should feed into the evaluation and reporting of PPI. Conclusions While most trialists fully implemented their documented plans for PPI there were traces of a minimalist approach.