Significant effort is being expended to improve people’s experience in trials, much of it through ensuring patient and public involvement (PPI) is built into trial development and delivery. However, the focus of much PPI work is on the process of patient and public input to trials, and less on assessing the output of such efforts in terms of how people experience the actual delivery of a trial. It has become clear through discussions with public contributors that failing to pay attention to how people experience trials is not acceptable. It is important that people feel valued when they take part in a trial, and that taking part is not a burden. If people have a good experience, this should encourage further participation in trials and high quality research. This will make it easier to do trials and make sure research informs clinical practice.
To improve people’s experience in trials, we first need to be able to measure that experience. The aim of this study is to develop a measure of experience in trials that is reliable and valid from a scientific perspective, that is acceptable to people, and useful for those running trials.
In order to achieve this aim, this study will address the following objectives:
Developing the experience measure (testing questions, response options and instructions, using cognitive interviewing techniques to explore how people interpret and respond).
Piloting the measure – testing the measure in a number of ongoing randomised trials, across multiple sites, to assess its performance.
Developing guidance and materials to assist trials units, investigators and other stakeholders (e.g. CRN and HRA) to respond to feedback from the measure to improve trial delivery.
The resulting measure would be made available for use across the trials portfolio. The developed measure would not be viewed as ‘necessary and sufficient’ for better trials, but use of the measure alongside other ‘inputs’ to trial design (such as good PPI and detailed qualitative work) will add significant value and bring trialists closer to our goal of ‘patient-centred’ trials.
PACT is led by Peter Bower at the University of Manchester and funded by the NIHR Research for Patient Benefit Programme.
Katie Gillies; firstname.lastname@example.org