Public and patient involvement (PPI) in the design, execution and dissemination of a trial: the BISTRO trial.

Abstract

Background: For people receiving haemodialysis, a balance has to be struck between removing sufficient but not too much fluid during a treatment session and maintaining any remaining kidney function they might have. In the BISTRO trial, this study sought to establish if getting the balance right might be improved by the additional use of bioimpedance, a device that measures body fluid composition to help decide how much fluid to remove during dialysis. Designing and executing this trial, which incorporated complex and repeated trial procedures that would be dependent on participant engagement, presented challenges that demanded effective public and patient involvement.

Objectives: This study aimed to develop an effective public and patient involvement participation model, ensuring that the patient voice was heard by the Trial Management Group, with a Patient Advisory Group undertaking coproduction of all participant-facing documents and communications, including dissemination of the trial results, with the main purpose of maximising participant engagement in the study.

Design: An open-label randomised controlled trial in which 439 participants from 34 centres were allocated for regular assessments of their bodily fluid content with or without the use of bioimpedance measurements.

Interventions: Development of an effective public and patient involvement working model that was represented within the Trial Management Group, contributing to protocol design, selection of bioimpedance device, and coproduction of all participant-facing communications including dissemination of trial findings.

Main outcome measures: Public and patient involvement contribution prior to trial initiation, description of the participant-facing communications, adherence to trial materials, dropout and dissemination of trial findings. Post-trial evaluation by research teams, Patient Advisory Group and co-applicants.

Results: An effective working model was developed which relied on remuneration of the public and patient involvement patient lead and use of social media (e.g. WhatsApp) to maximise inclusivity. The Patient Advisory Group coproduced with the Trial Management Group a series of communication postcards and newsletters and a web page to support the participants and disseminate the trial results that were highly rated by research teams, but not always passed on to trial participants. Participant adherence to the main trial outcomes was excellent (113.6% urine collections obtained). Potentially avoidable dropout was 14.4%, with 3.6% being clearly attributable to inability or unwillingness to comply with the trial procedures. Reflections by the Patient Advisory Group indicated that they felt valued, involved and listened to but anticipated more direct involvement with the trial participants, recommending that barriers to this be addressed during the trial design and set-up.

Limitations: Evaluation of public and patient involvement was retrospective and there was a lack of real-time assessment of the impact of public and patient involvement that might have supported a causative link between public and patient involvement interventions and the successful delivery of the trial.

Conclusions: Public and patient involvement played an important role in the design, delivery and dissemination of the BISTRO trial. Key to this success was the close relationship between the Patient Advisory Group and the Trial Management Group. Given the complexity of the intervention, dropout was reasonably low and did not compromise trial findings, but reasons were not always clear. Prospective gathering of data to capture the impact of public and patient involvement is recommended and direct support for participants facilitated.

Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 14/216/01.