We envisage that these be considered alongside previously published guidance for PPI in trials17 20 and consensus principles for PPI in health research.34 35 The tips generated from evidence in our study cover the importance of early planning, of timely and flexible PPI, and of communication and clarification of roles. They also stress the need to consider the difficulties CHIR99021 252917-06-9 posed by the use of ‘jargon’, and problems contributors experience in understanding certain aspects of the research process. The difficulties contributors experience with specialist

or technical terminology have been widely reported.19 32 33 Our data suggest that this problem has existed for some considerable time, and we outline the practical solutions suggested

by PPI contributors. The tips in box 1 could be used to inform PPI training and could be helpful in other types of health research. Given that the usefulness of the points in box 1 depends on researchers’ willingness to genuinely engage with PPI, the tips we present might also assist funding bodies and grant reviewers in determining whether submitted plans are fit for purpose. A study of the UK health and social care research community has recently informed the development of a Public Involvement Impact Assessment Framework (PiiAF), which emphasises the value of well thought-through planning before implementing PPI as well as the subsequent evaluation of its

impact,36 and INVOLVE17 have emphasised the importance of clear guidance about roles. However, researchers also need some scope for flexibility and contingency in planning PPI: our finding that some trialists expanded their sometimes already detailed plans supports the need for flexible and iterative approaches to PPI in order to accommodate the unexpected and respond to opportunities and difficulties as they arise. Box 1 Tips for planning and implementing patient and public involvement (PPI) in clinical trials Early PPI “You’ve got to plan ahead” Begin planning PPI and consulting with contributors when starting to plan the trial. Consider including PPI contributors in managerial roles for AV-951 example, as co-investigators. Researchers and PPI contributors emphasised how early and regular involvement allowed contributors to input more effectively. PPI prior to the trial (eg, in contributions to grant writing, trial design, feasibility studies) was a key aspect of PPI, and in some cases the most important one. Flexible PPI “One size does not fit all” “Reaching out was crucial” Consider whether oversight PPI (eg, on a trial steering committee) is sufficient to meet trial needs. Involve more than one or two PPI contributors, more than once or twice a year. ‘Reach out’ and make use of multiple modes of PPI, including responsive PPI.