Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views and experiences

Abstract

Background and aims: Patient and public involvement (PPI) in the design and conduct of surgical trials historically has been absent or minimal, but it is now recommended routinely and even required by some research funders. We aimed to identify and describe current PPI practice in surgical trials in the United Kingdom, then explore the views and experiences of surgical trial staff and patient or public contributors in relation to these practices. This was part of a larger study to inform development of a robust PPI intervention aimed at improving recruitment and retention in surgical trials. Methods: Two stages: (1) Online survey to identify current PPI practice in active UK-led, adult surgical trials; (2) Focus groups and interviews with key stakeholders (surgical trial investigators, administrators and patient or public contributors) to explore their views and experiences of PPI. Results: 129 eligible surgical trial teams were identified and 71 (55%) took part in the survey. 54 stakeholders subsequently took part in focus groups or interviews. Sixty-five (92%) survey respondents reported some kind of PPI, most commonly at the design and dissemination stages and in oversight or advisory roles. The single most common PPI activity was developing participant information sheets (79%). Participants reported mixed practice and views on a variety of issues including the involvement of patients versus lay members of the public, recruitment methods, use of role descriptions and payment for PPI contributors’ time. They suggested some solutions, including the use of written role descriptions and databases of potential PPI contributors to aid recruitment. Conclusions: UK surgical trials involve patients and members of the public in a variety of different ways, most commonly at the beginning and end of the trial lifecycle and in oversight or advisory roles. These are not without challenges and there remain uncertainties about who best to involve, why and how. Future research should aim to address these