Introduction
Pustular psoriasis had been identified as an area of unmet need during the development of the NICE guidelines49 on the management of psoriasis, which had substantial input from participants and the public, with the lack of effective/safe interventions in pustular psoriasis being highlighted as a research gap. In addition, the Psoriasis Association, the largest and most important UK patient organisation for people with psoriasis, had also made a major commitment to this area by funding two PhD (Doctor of Philosophy) studentships at King’s College London investigating disease pathogenesis. The study group, therefore, invited Helen McAteer, Chief Executive of the Psoriasis Association, to partner with the study group to ensure that we effectively engaged with participants and the public in the design, implementation, evaluation and communication of programme of research.
Aim
To develop a trial PPI infrastructure that would:
advise on study design and ethics issues
develop patient support materials and questionnaires
facilitate shared learning and reflection from the study
advise on the best methods to disseminate research outputs and review articles for publication in the lay press.
Methods
Qualitative feedback through the Patient and Lay Members Group
When the outline application was being made, one-to-one discussions were held with participants (n = 3, two with APP requiring systemic therapy, and personal experience as study participants in a placebo-controlled randomised controlled trial) for their advice on the study design and outcome measures.
For the development of the full application, a formal PLAG meeting was held that consisted of one patient with APP, one patient with GPP, one patient with psoriasis, a NICE psoriasis guideline committee member, Helen McAteer, the Biomedical Research Centre PPI co-ordinator and (the chief investigator) Professor Catherine Smith.
Patient representation in trial committees
Helen McAteer was enlisted as a co-applicant to the study to support study design, for ethics issue consultation and to help with recruitment using social/web-based media. She was also a member of the Trial Steering Committee (TSC) and the monthly Trial Management Group (TMG).
A patient representative (David Britten) was part of the TSC and regularly attended and actively participated in these meetings to provide guidance and support to APRICOT.
Social media communications
During the study, Giselle Folloni, a very active PPP patient based in Italy, who is very active on the PPP community on Facebook (Facebook, Inc., Menlo Park, CA, USA; www.facebook.com), became an advocate for the study. They regularly received study updates and newsletters and promoted the study on Facebook.
Patient and public involvement events
The APRICOT study was regularly mentioned at all of the PPI events held by the St John’s Institute of Dermatology (at Guy’s and St Thomas’ NHS Foundation Trust), Manchester and Newcastle. During these events, participants were asked for their feedback and suggestions about the trial experience (for themselves) and how it could be potentially improved. These findings were fed back to the central co-ordinating team for consideration by the TMG/TSC.
Impact of patient and public involvement on the study results
Trial design and development
The discussions held with participants for the outline application motivated the decision to limit the trial treatment duration to 8 weeks and to also extend the scope of the patient-orientated outcome measures for the study, including the pustular psoriasis-specific QoL.
The PLAG meeting shaped the trial design and led to amendments (e.g. the inclusion of a rescue topical corticosteroid) that were applied to the full application prior to formal submission. With respect to samples for mechanistic studies, the PLAG considered and approved the planned sampling strategy, including skin biopsies.
Helen McAteer was very influential in the study design and also provided ethics guidance for the amendments that were made to the trial that affected participants.
Trial delivery
The Psoriasis Association participated regularly in discussions about recruitment strategies and were extremely helpful in advertising APRICOT via social media, its magazine and its website. It helped to guide participants, directing any queries to the study website and e-mail address (where interested parties could self-refer). It also helped with the review and amendment of study materials. David Britten (the TSC patient representative) was very active throughout the whole study and offered meaningful insight into participant outreach and retention. He also contributed to vital discussions on strategy and study design and helped to form various trial-related materials. For example, for the submission of substantial amendment 12 (to add a new exclusion criterion relating to Still’s disease), his input and feedback was used to gauge the scope of changes needed for the protocol and participant information leaflet.
The PPP patient (Giselle Folloni) in Italy was an immense promoter and supporter of the trial, and their Facebook posts led PPP participants to the study website and raised an awareness of both APRICOT and PLUM in the PPP community.
The study design involved a randomised controlled trial with a placebo. Patient feedback suggested that some were concerned about missing out on treatment if they were in the placebo group and this became a concern that was instrumental in devising and implementing the OLE to help boost study recruitment.
Furthermore, in response to feedback from the TSC patient representative, various sites and potential participants, study sites were encouraged to ensure that it was made clear to all potential and actual participants that travel expenses would be reimbursed in full. This was important given that a number of participants had to travel significant distances to attend study visits.
Trial results and dissemination
Helen McAteer has co-authored a number of related publications and has critically appraised this report. We have drafted a results communication plan including a PPI event. This is an ongoing project to be delivered over 2021/22.
Discussion and conclusions
The PPI experience in APRICOT was astoundingly excellent and decisive, and enabled the study to recruit to target.
The input gained from the PPI was important in designing the study and also in shaping the trial once running. Fundamental changes to the trial design (e.g. the removal of some visits in substantial amendment 4 and the addition of the OLE as part of substantial amendment 12) were heavily informed by PPI. The same can be said for development of the study-related literature and patient-facing documentation and the amendments made to them throughout the study.
Patient and public involvement was also crucial in the promotion of the trial, which ultimately generated study awareness and helped to enhance recruitment.
Beyond the study, Helen McAteer and the Psoriasis Association have provided useful guidance on how to disseminate the study results and logistical support in doing so.
Reflections/critical perspective
The PPI network had a completely positive effect on the study and there were no negative factors of the involvement of the individuals and their conduct.
One possible suggestion that could have enhanced the PPI would be to seek to include more than one formal lay patient representative to the study infrastructure to reflect the PPP patient population more accurately and to enable more diverse conversations and guidance. A recent PPI event held during the pandemic over Zoom (Zoom Video Communications, San Jose, CA, USA) on psoriasis had more than 120 attendees; the question and answer format worked well, suggesting that virtual formats may be an efficient, and cost-effective, way of engaging a wider audience that would appeal to participants. We are exploring this format for our PPI results dissemination strategy.
