There were a few

trials for which we were unable to confirm http://www.selleckchem.com/products/17-DMAG,Hydrochloride-Salt.html whether plans were implemented in full, but all did incorporate some PPI. Many trials implemented multiple modes of PPI, which is surprising and encouraging given that PPI was less prominent when the proposals for the trials in this cohort were being developed. CIs encountered complications from which they learnt valuable lessons. Uncertainty about what to expect of PPI and emergent challenges with their trials meant that involvement had to evolve. Difficulties finding and retaining suitable contributors and engaging in PPI ‘too little too late’ led trialists to say they would do things differently in future. Many reflected on how they would aim for

earlier engagement next time and seek involvement from a more diverse source such as patient panels or focus groups. PPI contributors themselves mentioned that becoming involved after the trial had begun, or infrequently, resulted in missed opportunities for them to contribute. Some referred to uncertainty about their role and many struggled with jargon, an enduring problem despite the availability of apparently straightforward solutions. Pressured into PPI? Regardless of statements about PPI in their funding application some trialists had no expectations of what PPI might achieve, and their only motivation for including PPI was a belief that it was necessary or would help to secure funding for their trial. Such strategic minimalism may be an inevitable side-effect of policies to promote or require PPI in trials. It may also reflect researchers’ professed inexperience of PPI. A small number of trials did not have documented plans for PPI but all did nevertheless include some PPI, possibly influenced by reviewer and panel

comments. However, one of these trials had been through several stages of PPI prior to the grant application and was requested to implement further PPI over the course of the trial. This highlights the predicament of researchers whose trial may have benefited from considerable PPI prior to funding (eg, in feasibility Cilengitide and pilot work) and forecast that they would need relatively little PPI during the trial itself, only to find that funders insist on PPI at all stages. Many informants believed formative PPI prior to funding was one of the most useful, credible aspects of PPI. Particularly in cases where there has been extensive PPI prior to the main trial, it is important for all members of the research community to consider whether plans for ongoing PPI match the needs of a particular trial and at what stage(s) further PPI would be appropriate. Previous research We found no previous reports on the extent to which documented plans for PPI within trials were subsequently implemented.