The panel structure and the central panel
The EPAD panel set-up drew upon the experience of the PREVENT Dementia Study (30). Key features of the EPAD participants’ panels included a nested panel structure, in which multiple local panels function independently (Figure 1). Nominated members from these local panels then formed a single study wide panel, termed the central panel. Nominations for membership to the central panel were by peers within the panel, with no staff involvement. This central panel met in 2018 and 2019, at the General Assembly of the project. . The central panel meeting was chaired by the EPAD Ethics group and was closed to other members of the consortium unless specifically invited by the panel members. The structure of each panel is described below, with an overview of the structure provided in Table One for comparison.
The central panel meeting had two main goals – to co-ordinate activities across the local panels, and to provide for direct participant input into the development of the study. Participation in the General Assembly provided the opportunity for participants to learn about the progress of the study, to input into the primary decision-making body of the consortium, and to provide feedback through both plenary and closed meetings. The latter were formally chaired by the EPAD ethics workgroup, although informal breakout meetings were also convened by panellists themselves to enable learning across different countries’ panel experiences.
Meetings of the central panel took place in 2018 and 2019, with six and ten members respectively attending both the panel meeting and the General Assembly. In addition, one participant representative attended the 2017 project General Assembly, at which point only the Scottish panel had been established. Consequently, no central panel was held during this meeting. During the central panel members could discuss items that had arisen during their local panels, raise topics for discuss and discuss agenda items introduced by the EPAD staff. Panel members then fed back on their experiences from the central panel and General Assembly attendance at local panel meetings.
In addition to meetings of the central panel, participant panel members have also contributed to the planning of the future direction of the project as it approaches the end of its initial funding. Participant panel members from two EPAD countries worked with the research team in planning for the sustainability of the project and the long-term use of EPAD samples and data.
Each country was given a mandate to establish participant involvement on either a research centre or country level in the form of a panel. Whilst the common language spoken at the central panel was English, requiring a certain level of ability to speak English, the local panels facilitated multi-lingual involvement with participants. A terms of reference document was created as a guide for research teams (Appendix One), however these terms could be adapted as appropriate to meet local requirements and based on discussions with local panel members. This discussion was a key stage in establishing and managing the expectations of participants and researchers about the participant panel role. We describe below the set up and running of the panels with commonalities first described, followed by any unique adaptations made:
In Scotland there was an established centralised country wide panel, with membership from four recruiting centres (NHS Lothian, Grampian, Greater Glasgow & Clyde and Tayside). The choice to form one country wide panel was advocated for by the participant members and worked well in a geographically small country. Towards the end of the project a participant led panel was also established in NHS Grampian. Panel members from Grampian advocated for this due to interest from their fellow participants in the area to contribute their feedback to the panel without joining the Scottish wide group.
England: OXFORD, WEST LONDON AND BRISTOL
England similarly established a panel to represent participants from multiple centres. The panel ran from Oxford, England and involved participants from three centres (Oxford, West London and Bristol).
The Netherlands: Amsterdam
The panel in the Netherlands was housed at the VuMC (Vrije Univercentreit Medical Centre). As there was only one centre in the Netherlands this panel operated both as the country and centre wide panel.
France had one panel in operation, based and run from the Toulouse centre. As one of the largest centres in the EPAD study Toulouse was able to harness the participant voice onto this panel.
Spain’s panel was in Barcelona, the first EPAD centre to open in Spain.
Establishing the panelS
The panels were in operation for a range of time, with the Scottish and Barcelona based panels established in early 2017, and the newest panels, England and Toulouse, established in 2019. All panels have met at least twice at the time of this paper.
Panels employed a variety of recruitment methods during the initial set-up period, all of which were successful. Three panels (Scotland, England and Toulouse) contacted all local participants via letter or email to explain that a participant panel was being established and asking for interested participants to contact the coordinating centres to receive more information. In Amsterdam the panel was first introduced during an annual meeting for participants, to which all EPAD participants were invited, and the panel opportunity was followed up during the dissemination of minutes from this meeting. In order to maximise the engagement of the participants and the output of the panel, the team in Barcelona established a list of criteria for the selection of the potential panel members such: proximity to the centre, sex, age, English language level, motivation. These were participants who had previously expressed interest in being more involved in the study and each participant was contacted by phone to assess interest in joining the panel. Most panels enrolled people on a first come first served basis, with the exception of Toulouse which enrolled based on longevity in the EPAD study. At the time of the cohort study closing a waiting list was in operation at the Scottish, English, Toulouse and Barcelona panels due to levels of demand. New recruits were informed about the participant panel using flyers in Scotland and via email in Barcelona, whilst Amsterdam elected to maintain a static panel as the participants involved have the most experience of the EPAD study and were motivated to remain in the panel. Scotland is a unique example in this group as it was initially established as an Edinburgh based panel and had since expanded on the advice of the panel members to include participants from all Scottish centres.
The initial meetings of each panel involved similar agendas set by EPAD staff, with setting the scene and explaining the purpose of the panel, establishing rules of engagement around confidentiality and terms of reference for the panel, and nominating a participant as chair of the panel. At the Barcelona and Toulouse panels, a vice-chair was also selected to support with the leadership of the panel.
Logistics of running the panel
The panels were all set up to run twice a year, with ad-hoc contact in between for matters arising that are time sensitive. The Barcelona panel met up to 4 times a year on the request of the participant panel members. Numbers of panel members ranged from 7 at Amsterdam to 12 in the Scottish panel, with the group size aimed to be large enough to capture a diversity of experience and opinions, whilst remaining small enough to allow everyone time to meaningfully contribute to the meetings. EPAD study staff were in attendance at every panel meeting, and in most centres the Chief Investigator or Principal Investigator also attends. The staff attended to organise the logistics of the meeting, provide study updates and answer specific questions from the panel, facilitate discussions if required and to minute the meetings. Panels met at locations convenient for participants, travel expenses were provided alongside refreshments, be that coffee or lunch depending on the preferred time of the meeting at each centre. Communication varied between countries depending on formats allowed under data protection laws, and included email, post and closed WhatsApp groups.
Content of panel discussions
Panel meeting agendas were developed by the participants, led by the panel chair. Using the Scottish panel as an example there were standing agenda items including dementia moments (recent news stories about brain health and dementia), an update on the study progress to data (both internationally and for Scotland) and the proof of concept trials. Additional topics were then added to each meeting as desired by the participants. Additional topics discussed by panels included sustainability and longevity of the project, feedback on the study visit (including experiences, practicalities and logistical aspects), documentation review and discussions around receiving results on potential risk factors discovered through the EPAD study.
Study advocacy and engagement
Panel members have attended a variety of events in every country to speak about their involvement with EPAD and contribute to meetings based on their experiences both as participants and as panel members. These include the IMI Stakeholder Forum 2017 where a participant represented the EPAD study on a panel discussion on PPPI, National Research Scotland (NRS) annual meeting in Perth 2018 where two panellists co-authored a poster about the panel, the EUPATI (European Patients Academy) 2018 meeting where two panellists spoke about their involvement in EPAD, and co-hosting a webinar to discuss the set up and running of a participant panel to support other centres considering hosting a panel. The Scottish and English panels have both contributed to the annual EPAD conferences held in these countries where all centre staff gather to share experiences with the study. The Barcelona panel are credited by centre staff with raising the profile of Alzheimer’s disease research in the Catalonia region through their outreach activities.
Review of study documentation
Review of study documentation, including the study website, has been an important role played by the panels, helping to ensure any information provided to participants is understandable and appropriate for use. Suggestions from the panel led to rewording of study documents, improving readability and adapting images used in videos. The feedback received on study documentation was described as ‘positive and constructive criticism’ by staff. Many of the panels discussed protocol amendments for their advice on local implementation of changes and how best to communicate this to participants. One of these changes included the use of animated videos to support the consent process, which was a new method of communication for most sites. By discussing amendments such as this with the panel, centre staff felt confident in the protocol amendment roll-out across the centre.
The Barcelona centre has developed videos with the panel focusing on the mandatory lumbar puncture procedure in the study protocol. Perhaps unsurprisingly, participant panel members in most countries discussed experience of lumbar punctures and suggested improvements for the information provided about these. From these discussions the Spanish panel worked with the Barcelona centre to develop two videos about the procedure, one describing the procedure and one providing volunteers personal experience of undergoing the procedure. Participants were able to watch these videos prior to the procedure as a communication mechanism to support with the learning about the procedure, with staff noting a a reduction in pre-procedural nerves for some participants. This was a technique similarly used in the UK based Deep and Frequent Phenotyping pilot study where an explanatory video was produced in collaboration with the Alzheimer’s Society (32, 33). In Amsterdam, the panel initially fed back that they often did not know whom they were seeing during their visit, as the complex procedures required a large number of staff to successfully deliver the study. Following this the team introduced a ‘study card’ to better explain the logistics of the visit and the roles of the EPAD team members involved, with the panel members collaborating on the wording and presentation of this card. This simple communication tool aimed to ensure that participants have the knowledge they want and need about their study visit, improving their overall experience at the centre.
The study experience
Panel members discussed their recent study experiences during their local panel meetings, which led to a number of changes being enacted at centres. Some of the changes were relatively minor, such as an improvement in signage to one of the Scottish centres. Communication between researchers and participants was a common theme with advice sought on how people wanted to receive abnormal results discovered during the study (such as abnormal blood pressure, blood results or magnetic resonance imaging (MRI) findings of clinical significance). The preference from panel members was for this to be done with a personal connection, either over the phone or face to face, as opposed to receiving a letter or email with the results. As such this method of feedback for clinically significant results was implemented. Another communication change related to collection of saliva samples, which involved a relatively complex home collection method. After expressing some difficulties with this collection sites were able to spend more time discussing the instructions with the participants and suggesting helpful reminders such as setting alarms on a mobile phone for when the sample should be collected.
While the study as a whole did not routinely communicate the results of cerebrospinal fluid (CSF) tests to healthy participants, in Amsterdam the participant panel advocated for disclosure of the CSF data on the explicit request of the participant. This led to the development of standard operating procedures to support with this, and to the disclosure of amyloid status to 20 participants based at the VuMC centre.
Participant panel members from Scotland and Amsterdam were invited to participate in a meeting to plan the future of the EPAD study following the end of the initial funding period. Prior to this meeting members of the EPAD consortium (EPAD sites, academic and industry partners) had completed a survey to outline their views on what EPAD should prioritise to continue in the next stage of the project. During the meeting these survey responses were reviewed and a guidance document produced to advise the EPAD Management team on the next steps they should take and the possible outcomes of how the study could function in the next phase. Panel members were asked to attend to give a voice to the participant experience and add their views to how EPAD should evolve. Their views contributed to highlighting areas of convergence and divergence between participant and researcher perspectives, and to reinforcing the importance of maximising long-term sustainability of the study biobank and database.
Participant panel perspective
Members of the Scottish and Spanish participant panels were asked by a panellist co-author to reflect on their experiences of the panel and provide feedback for use in this evaluation of the panel successes. All other panels were able to get input from at least one participant panel member. These experiences are reported below.
Prior to joining the panel, members had few expectations of what joining might mean, and there was some doubt about how much ‘influence the participants would have on the day-to-day workings of EPAD’. People did anticipate that the meetings would be forums to ‘provide feedback on our EPAD experiences’ and ‘the chance to get to know other participants and to share experiences with them’. Participants thought the panel would offer an avenue for collaboration and to spread the word about both EPAD and Alzheimer’s disease. Panel members were often motivated to join the panel by their personal experiences of living with parents with dementia.
Considering the set-up of the meetings, panel members felt there was a ‘nice balance’ of a structured approach that remained ‘flexible as the agenda is set by the participants in conjunction with EPAD staff’. Members appreciated the attendance of staff members who are ‘aware of the items on the agenda…and know the outcome of each discussion’. They report the meetings as ‘inclusive’, with a pleasant working atmosphere, and the Scottish group in particular note that ‘the fact that [the Principal Investigator] takes the time to come to meetings is hugely empowering’. These experiences demonstrate the importance of providing resources to participant groups to ensure efficient operation and maintaining an informal and flexible meeting style to encourage all participants to voice their experiences and opinions. In some centres participants advocated for more regular meetings. This led to conflicts between the ambitions of the panel and desire for increased regularity of meetings, against the limits of resources the research team have to allocate. The Barcelona team had been able to support an increase in regularity of meetings, whilst other centres maintained a six-monthly schedule. Other centres were able to discuss the limitations of resource and agree with the panel that meeting twice a year would be acceptable.
Panel members reflected staff views that their input had helped to improve the participant experience by providing ‘a forum for participants to have their concerns voiced and attended to’ which has made the yearly visits to study centres ‘as comfortable as possible’. Importantly the panel members were key decisions makers in ‘the decision to have a Scottish panel rather than a participant panel for each Scottish trial delivery centre’. By combining the collective experiences from these centres it is likely the panel has been able to have a bigger impact than that of four individual panels. They felt that it is clear that the Scottish Participant Panel has ‘done a great deal to publicise the study, to disseminate the Scottish experience and to learn from what’s happening in other countries’. The panel has managed to solidify participants as stakeholders in EPAD, by ‘reinforcing (sic) their importance in the scheme of things’ and demonstrating the ‘humanity of EPAD’. Participant panel members felt they had contributed to ‘the transition from EPAD to EPAD2’, which relates to sustainability discussions about the long term goals of the project, in which the participant voice has been invaluable. Panel members reported attending numerous events but by meeting other panel member groups from across Europe at the EPAD General Assembly, the groups ‘had found a voice’. One panel has the slogan ‘we want to be part of the solution’ and this ethos is clearly reflected in many of the EPAD participant panels.
Discussions were held in panels to develop strategies to make sure ‘everyone’s voices [are] heard by the research team’, not just those who were panel members. As part of this the Scottish group set up a satellite participant led group in Aberdeen which fed into the country wide panel.