Methodological Research Priorities for developing PPI in clinical trials.

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METHODICAL

A recent priority setting exercise, the METHODICAL study, has identified sixteen critically important research topics to improve Patient and Public Involvement (PPI) within Clinical trials.

PPI in Clinical trials is seen as increasing important and many UK funders now require researchers to provide evidence of how it has and will inform their studies. Traditionally PPI tends to involve a small number of patients or members of the public (known as PPI contributors) to offer a distinctive perspective to researchers or clinicians on the design and conduct of a trial. Some PPI contributors will have direct personal experience of the condition being investigated, whilst others bring general experience of being a patient or service users.

Despite the emphasis on PPI in the UK and internationally, there are uncertainties about how best to implement it, about the purpose of PPI and whether it actually does improve research.

We recently undertook a national priority setting exercise to determine the methodological research priorities for addressing these uncertainties. 237 people from across the UK registered to take part in an online two round Delphi survey, representing  a wide range of PPI stakeholders such as PPI contributors, funders, chief investigators, trial managers, researchers, PPI coordinators and PPI advisors.

A face to face meeting of 25 randomly chosen representatives from across the stakeholder groups was used to discuss the online survey results and decide on future research priorities. Sixteen topics were voted as critically important and should form the basis for future research.

The METHODICAL results have recently been published in the journal Health Expectations (http://onlinelibrary.wiley.com/doi/10.1111/hex.12583/full) and we are now looking to facilitate the start-up of collaborative working groups on each of these critically important topics. The aim is that these groups will generate future grant proposals in order to develop the evidence base for PPI.

If you are interested in the results of the study, or would like to register to be part of a working group please visit www.methodicalstudy.uk.

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