Aim of patient and public involvement
The overall aim of our patient and public involvement (PPI) strategy was to include people with FMD in all phases of the research, from design to dissemination, in order to optimise benefits of the intervention, relevance of the study findings and to ensure that the research was conducted with the well-being and interests of service users (SUs) in mind.
The specific aims of PPI in the development phase were:
- to ensure the research questions were meaningful
- to ensure the study intervention matched patients’ priorities and expectations for treatment
- to ensure the study procedures were acceptable
- to ensure the study outcomes were meaningful and relevant.
The specific aims of PPI during the trial were:
- to support and advise on the conduct and management of the trial
- to input into the interpretation of the results
- to support and oversee dissemination of the results to relevant stakeholders.
Methods of involving patients and the public
Knowledge from previous PPI during the intervention development phase and feasibility testing was carried forward to the current study. To further inform the research design, we carried out a large patient and public engagement project via social media, with support from patient charities, FND Hope UK and FND Action. In the first stage, 139 people who identified themselves as having the diagnosis of FMD took part by listing their priorities for treatment. In order of importance, the top five priorities were: (1) improve walking; (2) improve ability to work/study; (3) improve pain; (4) improve fatigue; and (5) understanding what is wrong. In a second stage, we invited people to join a dialogue hosted on a Facebook discussion group. Fifty-five people joined this discussion, where comments were invited on various themes related to the research. An additional workshop was held with two SUs and a family member to review the protocol, participant requirements, outcome measures and patient-facing documentation. The findings from this work informed the design of the intervention and the trial protocol.
Once funding for the trial was awarded, the primary method of PPI was through representation on the Trial Management Group (which met approximately 6-weekly) and the independent Trial Steering Committee (which met approximately 6-monthly). Two PPI representatives were appointed to each committee. Latterly, an additional PPI member, representing patient charity, FND Hope UK, was invited to join the Trial Management Group to support the existing members and assist with interpretation and dissemination of the trial results. Each PPI member attended a training day to help them prepare for their role in the research. PPI members were encouraged and supported to be active members of their respective committee ensuring their point-of-view informed decisions, analysis and the write-up.
Results of patient and public involvement
Patient and public involvement shaped the research design in a number of ways. Firstly, PPI provided reassurance that the randomised design was acceptable, ethical and started from a position of equipoise. Other examples include the social media project finding that improved mobility was the highest-ranked priority outcome for treatment influenced the choice of the primary outcome (SF-36 Physical Functioning domain); the number of assessments were reduced to lessen the participant burden; and three choices for the method of completing trial outcomes were added to improve ease and accommodate for various potential difficulties.
The PPI perspective influenced the decisions and advice provided by the trial committees, and this was particularly important when developing a COVID-19 mitigation strategy and plans to restart the trial after pausing during the initial pandemic. PPI members helped to consider the risks of restarting face-to-face treatment and balance the risks against the potential benefits from access to treatment. There was a perception among PPI members that people with FMD had suffered from the lack of access to treatment during COVID-19 lockdowns, and that continuing the trial with risk limitation strategies was of high importance.
Patient and public involvement was important to increase the reach of our dissemination strategy. Together with our PPI collaborators, we co-designed an animation, summarising the main trial findings.30 The PPI group also assisted with social media dissemination, which is highly used by the patient community. A post of the trial animation on X Corp. (X Corp., San Francisco, CA, USA) (formally Twitter) had received 204.7 thousand views between 24 July 2024 and 18 November 2024.37
Discussion, conclusions and reflections
We underestimated the burden of the role when inviting our PPI members to collaborate. Their commitment turned out to be over 5 years in duration, longer than initially planned due to COVID-19 delays. An additional PPI representative was appointed when the trial restarted after COVID-19 to share the burden of the work. Our PPI members were essential to the delivery of the trial and, without exception, were a positive influence during all stages.
People with FND commonly report negative interactions with healthcare professionals and often feel abandoned by the healthcare system.38,39 Collaboration with SUs was, therefore, crucial to ensure the research addressed the priorities of patients and for ensuring the trial intervention and research procedures were acceptable and relevant. The high levels of satisfaction in participants receiving the trial intervention and high retention over 12 months reflect the value of our ongoing SU collaboration.