The PAX-BD PPI group undertook a comprehensive review of the involvement of PPI in the trial and concluded with a set of recommendations for future studies. The full PPI group report (authored by the group) can be found in Appendix 6. A brief summary is provided here, including the conclusions and recommendations as written by the group.
Background
Public involvement is requested by most funders. However, this has the potential to lead to tokenism and several reviews of PPI have concluded that evidence of impact is weak. More evidence is required of public involvement in research to identify challenges, barriers and methods to overcome these to ensure appropriate and impactful public involvement.
PAX-BD was a complicated trial with several challenges due to participant recruitment, the trial population itself, amendments being implemented throughout the trial, the pandemic restrictions, personnel changes at the NCTU, the passing of our PPI lead and the early closure of the trial. This all led to the patient and public involvement and engagement (PPIE) group being able to assess the public involvement in the trial through the lens of facing and overcoming challenges as well as more generalised public involvement in a RCT.
Methods
The core methodology used in the analysis of PPI was the Guidance for Reporting Involvement of Patients and the Public 2 (GRIPP2) tool which aims to improve reporting of PPI within research. The GRIPP2 checklist, however, does not take into account the quality and impact of PPI on a trial, so the PPIE group also reviewed evidence following the work of Wilson et al. and reviewing PPI contributions utilising the dialogue and change award criteria designed by Investing in Children and the NIHR Applied Research Collaborative, North East and North Cumbria (ARC NENC). A retrospective review of all documentation relating to the public involvement within the trial was conducted, as well as holding a meeting with the public contributors and members of the trial team to get their views on the impact.
Conclusion
The PPIE group’s evaluation of the public involvement within the PAX-BD trial has been led by established PPI evaluation tools and frameworks. The group have identified numerous occasions of PPI impacting the trial as well as discussing the process of PPI integration within the trial and the personal impacts to the public contributors and the researchers. The group have created a list of recommendations to support future public involvement in research. The PPI within this trial was largely developed as it progressed which had both positive and negative impacts on the trial, the researchers and the PPI contributors and, with hindsight, there are some changes that the group would make.
Some limitations of this evaluation are that the group did not have the aim of writing this chapter/paper (i.e. as per Appendix 6) until towards the end of the trial, so some information may have been lost due to not being aware of the need for PPI record keeping. The original PPI lead sadly passed away in September 2021. She had been involved from the initial trial design and unfortunately was not able to participate in this assessment of the overall involvement which would have added more depth to the evaluation. A different PPI lead taking over created new ways of working which may have affected the views of and created a ‘before and after’ attitude towards PPI from the other PPI members and the researchers, possibly impacting the involvement from the group. The second PPI lead was not involved from the inception of the trial so has no reference for the period prior to funding being received and her joining the group in March 2019. There have been a number of different Trial Managers which could have impacted the level of PPI involvement in the trial due to a possible lack of consistency in contact for the PPI group.
Overall, the PPI input has been relevant, beneficial and impactful to the trial, the researchers and the public contributors, with one PPI group member with no previous research experience stating:
Actually, I’ve really enjoyed it. It’s been so interesting to listen to. I mean the upshot of all that is that I would definitely volunteer for a similar thing in future for sure.
This was felt to be an endorsement of the PPIE group’s contribution and conclude that the PPI input was successful. The detailed report of the positive and negative aspects of PPI within a RCT will hopefully help others to design and carry out effective and inclusive PPI to ensure that research is focused on creating improvements for the patients and public affected by the issues being investigated.
Recommendations
What worked well:
- Positive attitude of the trial team to PPI led by the CI.
- Flexibility for PPI members to be involved where they wanted to.
- Integration into the TMGs – status of PPI lead was never questioned as an equal partner in the group.
- Prioritising PPI as an agenda item for every TMG and CI catch-up meeting.
- Utilising people’s different expertise.
- Listening to carers as well as people with lived experience of the condition.
- Reactive PPI for changes to patient documents, trial amendments and recruitment.
- Using PPI voices to challenge the funders regarding recruitment and trial amendments.
- Feedback actioned and changes made to aspects of the trial that the PPI group reviewed or discussed.
- Feedback on changes made to the trial after PPI feedback was given to the group at the next PPI meeting keeping us informed of our impact.
- There was diversity of gender, lived experience of depression and BD and carers of people with bipolar disorder, age, disability, and research experience within the group providing a range of perspectives.
- Accessibility of documents and meetings for all PPI Group members was implemented following identifying our individual needs.
What not to do:
- Create the PPI as the trial progresses. Having a plan and some structure would have been beneficial to getting PPI involved in the appropriate places. Having a PPI member at the TMG and catch-up meetings did go some way to addressing this, but it still could have been more organised and streamlined.
- Missed opportunities for PPI input, for example designing the qualitative questions and involvement in themes and analysis.
What would we do differently next time:
- Involve PPI in more aspects of the trial – qualitative planning, possibly use as peer researchers to complete qualitative interviews, trialling the participant questionnaires and software.
- Involve the PPI group at an earlier stage when drafting patient documents to reduce time spent redrafting.
- Due to COVID-19, many changes to the trial had to be made very quickly and the PPI members were not involved in these as much as the trial team would have liked.
- More in-depth planning for PPI activities, for example, role-play calls, qualitative interviews to ensure appropriate involvement and inclusion of PPI in important trial areas.
- Training on relevance for PPI group members when providing feedback to researchers.
- Have a dedicated PPI lead within the trial team.
- More admin support for PPI Lead.
- More diverse PPI group members. We were all North East based, White British, mainly middle class.
- Larger PPI group – creates more opportunity for diversity, a range of voices and new ideas.
- PPI Funding – needs to be established as part of the funding bid. Budgeting for any additional tasks and involvement, not just meetings. Budget to cover a larger and more diverse PPI group.
- Voucher payments made in a timelier manner. Cash payments available if preferred.
- Maintain PPI records with the goal of authoring a paper showing the impact and learnings for researchers to use to support more effective PPI in future trials.
- Funding applications need to allow room for innovation and flexibility in terms of PPI plans, inputs and altering trial design, outputs and dissemination. You do not know what you will produce until you have the conversations with people with lived experience.
- Prior contact of PPI Group with funders re trial recruitment challenges may have supported trial extension rather than closure.