Patient and public involvement

Introduction

Within the UK, funders such as the National Institute of Health and Care Research (NIHR) have developed a strong policy approach, whereby there is an expectation for active PPI in research that they fund.183 Additionally, there is increasing awareness of the benefits of PPI contributors and their involvement in health research in order to deliver health services that meet patients’ needs.184 The impact of PPI on processes and outcomes of mental health research have shown that health interventions which included patient or lay involvement in design or delivery of patient information lead to greater recruitment rates185 and greater relevance of dissemination.186,187

In addition, it should be acknowledged that PPI contributions can vary from study to study and there is a useful pragmatic framework to measure this.186 They refer to low-level involvement as PPI contributors providing views to inform research decision-making, medium-level involvement as shared ongoing decision-making between PPI contributors and researchers, and high-level involvement as individuals with experience of the health issue having the dominant voice, delivering, and managing the research.79

It is important to note that we worked with the Involvement Centre at Nottinghamshire Healthcare NHS Foundation Trust to create a Magnetic Stimulation Advisory Group who co-produced the treatment pathway for prior pilot work,43 that was then extended to an LEAP. This chapter will focus on the LEAP’s involvement during the set up and delivery of the BRIGhTMIND study and throughout the chapter we will use the terms LEAP and PPI contributors interchangeably, but it refers to the same individuals.

The aims of PPI in the BRIGhTMIND study were to advise on: (1) study design and ethical issues; (2) take an active role in recruitment and selection of research and TMS operating staff appointed to the study; (3) co-designing participant information sheets and other study materials for example patient and public targeted study website; (4) provide recommendations for study and site-specific barriers; (5) assist with the inter-rater reliability and training of research assessors for the primary outcome measure of the study; (6) assist in the interpretation of findings, in particular the emerging qualitative analysis on barriers to recruitment and patient acceptability of TMS; and (7) assisting in the future dissemination of findings, whereby the voice of experts by experience will be heard in all dissemination activities. Additionally, over time, and with the challenge of the pandemic, the LEAP members also took on additional roles that are outlined below.

As we will report throughout this chapter, the LEAP members’ experiences and knowledge ensured that the study participants’ voices would be heard. This helped the trial consistently maintain strong patient focus.

Methods

Participants

Each research site was invited to nominate two PPI representatives to form an LEAP. We aimed to achieve a blend of experience with the previous work and new voices, as well as diversity, geography, and relevant experience (of TRD, TMS, and research methods).

The LEAP process was overseen by an experienced PPI lead who had trained supported and mentored several PPI groups over recent years, and who had previously worked with the chief investigator in a similar role.

As of 11 April 2022, the LEAP panel compromised of 4 females and 6 males, aged between 36 and 68 years, with three members Asian or Asian British and all others White British. The LEAP panel consisted of carers, individuals with lived experience of TRD and some members who had received TMS treatments themselves. Over the course of the study, there were five withdrawals from the LEAP, and when there were withdrawals the PPI lead advertised for new members by liaising with the research sites to find suitable replacements.

PPI recruitment for the TSC and DMEC were appointed through invitation from the funding body. This was on the suggestion of the PPI lead, as this needed to include people with no significant links to the LEAP.

Methods through which patient and public involvement members were involved

National LEAP panel meetings were conducted quarterly, to include all LEAP members, the PPI lead, chief investigator, and trial manager, which were originally face to face, before moving to remote video conferences due to the COVID-19 pandemic. The LEAP members felt the regular attendance of the chief investigator and trial manager at these meetings were helpful and very much appreciated. Researchers and site PIs were also invited to a number of these meetings to discuss the MRI imaging and qualitative elements of the study. On average there were seven LEAP representatives in attendance for the national LEAP meetings.

Participation payments and reimbursement of travel expenses were in place to cover national LEAP meetings and for the separate PPI contributors who attended TSC and DMEC meetings. The core commitment for the LEAP was the attendance to the quarterly national LEAP meetings. Members could freely choose whether or not to engage in other opportunities around the study. There was also financial support for these voluntary additional duties. The payment rates were in line with payment guidance provided by the NIHR Centre for Engagement and Dissemination (CED) and previously INVOLVE (national advisory group which promotes and supports greater public involvement in NHS, public health, and social care research), before its function was taken over by CED. For example, one of the meetings lasting 2–3 hours would attract a participant payment of £60 plus expenses.

Measurement of the impact of patient and public involvement

The impact of PPI on the BRIGhTMIND study was assessed through documented minutes of the national LEAP meetings and feedback from the individual research sites. Initially, these meeting notes and feedback were scrutinised by a member of the research team to assess impact of PPI. This narrative was then discussed with the PPI group to ensure there were no omissions.

In preparing this chapter, the Guidance for Reporting Patient and Public Involvement (GRIPP2) checklist short form was used as a framework. This aims to improve quality, transparency, and consistency of PPI evidence to ensure best practice.188 We also refer to low-level, medium-level, and high-level involvement when discussing PPI contributions.188

Results

The results section broadly summarises the PPI contributors’ involvement in trial design and development, trial considerations, recruitment of staff and participants, trial results and dissemination and COVID-19 practicalities.

Trial design and development

Low-level involvement

1. Provided feedback on strengths, weaknesses, opportunities, and threats (SWOT analysis), which informed decision-making on elements of the trial.
2. Recommended travel buddies and filming routes to facilities to help participants to appointments. We were unable to action this due to time constraints and funding. However, based on the PPI’s suggestions, RAs tried to ensure they were available to meet participants for MRI scans, with directions and maps provided to all participants and contact numbers for the research team and TMS staff.

Medium-level involvement

1. Patient information sheets and advertisement documentation were co-designed by PPI contributors and the research team.
2. Contributed to the monthly BRIGhTMIND newsletters, which were circulated to the study team to provide updates on study progress.
3. Qualitative acceptability study topic guides were amended based on suggestions provided by PPI contributors.
4. LEAP provided unanimous recommendations for preferred secondary outcome self-report measures which were adopted by the research team.
5. Voluntarily completed mock interviews of the primary outcome measure, for RAs to assess for inter-rater reliability and to provide feedback on how RAs could improve their performance.

High-level involvement

1. Had a significant dominant voice for including an adapted version of the Patient Global Impression of Change scale.95 Based on their advice, this measure alongside the patient acceptability measure were adopted. Without this, we would have had no measurement of change in outcome while the patients was receiving TMS.
2. Recommended a qualitative substudy to explore the reasons why BRIGhTMIND participants were requesting copies of their MRI scans. This substudy was co-designed and co-produced between PPI contributors and the research team.
3. PPI contributors provided, at first from their own initiative and then subsequently invited to submit reports to DMEC and TSC. The report detailed the work of the LEAP group and its impact, and a portion of both the DMEC and TSC meetings were set aside for such reports.

Trial considerations

Low-level involvement

1. During study design, it was initially proposed that 20 TMS sessions would need to be completed Monday to Friday for a 4-week period. However, based on the PPI contributors’ advice this treatment programme was adapted to a 6-week programme, with participants only able to have a maximum of 4 consecutive missed treatment days.
2. PPI contributors suggested we should offer a degree of flexibility in terms of the TMS clinic hours to take into consideration those that were employed and preferences for morning or afternoon slots. TMS was only provided within usual working hours Monday to Friday, however all sites however tried to ensure that the participants’ timeslot worked for them.

Medium-level involvement

1. The PPI contributors raised an important topic regarding participants not having access to further ‘top up’ treatments after the 20 sessions had been completed. They suggested this could be an ethical issue, and that variation in response to treatment and the duration of response should be clearer in documentation and conversations. The study was not able to provide ‘top up’ treatments. However, based on their advice, an amendment was made to the general practice enrolment letter and patient information sheets to state this.

Recruitment of research and transcranial magnetic stimulation staff

Medium-level involvement

1. A large proportion of staff members were employed to the study via redeployment or secondment. However, for those that recruited via formal, open, competitive interview, 71% of panels included a PPI representative. The PPI representatives had a significant impact on the outcome of interviews, with positive feedback provided from PPI representatives, other panellists, and job applicants.

Recruitment of participants

Low-level involvement

1. The PPI members suggested advertising the study on radio or TV. The BRIGhTMIND study was therefore featured on BBC East Midlands TV news. This helped the local site maintain consistent recruitment rates from June 2021 until the end of study recruitment. While this feature was focused within the East Midlands, it reached individuals outside of this location, with a number of referrals received by other research sites.
2. Recommended promoting the study at General Practitioner Continuing Professional Development events, Improving Access to Psychological Therapies (IAPT) services, primary care Clinical Research Network services and secondary care mental health services. These recommendations were utilised to varying degrees across the study sites. In particular a number of primary care and IAPT presentations were done in London and Newcastle.
3. The PPI members provided a number of suggestions for how to promote the study to increase diversity at sites in in East Midlands and North East England. This included targeting local areas with greater ethnic minority representation and advertising at places of worship. Posters were not put within places of worship due to the COVID-19 pandemic, however Newcastle promoted the study to the Community Treatment Team in the West End of Newcastle, which includes an area where a larger population of Asian people live and Nottingham targeted GP practices with greater percentages of BAME patients.

High-level involvement

1. The PPI contributors unanimously felt that the initial material on the BRIGhTMIND webpage (created on the Nottingham Institute of Mental Health website in December 2018) included too much scientific language. This feedback was actioned, with one LEAP member taking a lead in rewriting significant portions of the webpage content, and reviewing other sections written by researchers. Following an amendment approved by the REC, the webpage was recreated April 2020. Prior to these changes, the website averaged 139 views per month, which increased to 238 views per month following their input. The Northern Centre for Mood Disorders website also contained information on the BRIGhTMIND study, which was reviewed by PPI contributors, with recommendations for amendments including more accessible information on TMS actioned.

Trial results and dissemination

Low-level involvement

1. The PPI contributors asked us to consider wider dissemination beyond academic papers. This includes disseminating clinical and cost-effectiveness of the study to NHS Trusts, and sharing the standard operating procedures with NHS TMS clinics, to assist with good, standardised practice.

Medium-level involvement

1. The PPI contributors have aided the interpretation and naming themes for the qualitative acceptability study and with the research team, co-analysed the qualitative substudy exploring participants’ requests for MRI scans.
2. PPI contributors are being given the opportunity to co-author upcoming manuscripts and will be involved in the early stages of manuscript developments up until publication.

COVID-19 practicalities

Low-level involvement

1. The PPI members recommended a COVID-19 patient information sheet, which was adopted, to detail changes made to previous BRIGhTMIND study procedures. This was to help alleviate anxiety about face-to-face contact and detail measures put in place to ensure infection control and safety.
2. Most contact between researchers and participants changed to remote methods, with face-to-face contact requiring staff and participants to wear face masks. PPI recommended a document, which was adopted, with staff’s photographs and profiles, to help alleviate participants’ anxiety and break communication barriers and worries.
3. The PPI contributors reminded the researchers of the importance of family support and the impact of relatives no longer being able to join participants at face-to-face meetings. As such, sites gave participants the option for family to be present during the remote appointments. Family members were also able to attend MRI scans and TMS treatments in exceptional circumstances ‒ once it was safe and permitted to do so.
4. The PPI contributors were also concerned that travelling and transportation to and from the treatments could be an issue during the pandemic. Family members providing transport would also have nowhere to wait due to lockdown/safety issues. While these concerns were acknowledged by the research team, no further changes for travel could be actioned due to both funding and COVID-19 legally binding restrictions.
5. The PPI members recommended that the BRIGhTMIND study webpage should be updated to notify the general public of when the study would resume recruitment. This recommendation was actioned, and the webpage was updated when each site was permitted to restart recruitment.

Discussion, reflections and critical perspectives

The BRIGhTMIND study demonstrated that a combination of low, medium, and high levels of PPI contribution can have a successful impact on the development and implementation of a complex health intervention. This is the first multicentre trial of MRI-neuronavigated TMS in the UK, and it was essential for both the research team and the LEAP group to co-produce important elements of the project to ensure its successful completion. This chapter demonstrates that involvement is not a fixed role, but of one that can grow over time as an organic process dependent on context and the need to adapt to challenges. The PPI contributors’ conduct, invaluable knowledge, and input into the trial led only to improvements and there were no negative factors identified.

The LEAP provided significant input into the design, development and running of the study, including the co-production of patient-facing documentation (e.g. patient information sheets, posters, and websites) and qualitative topic guides. They had a dominant voice in improving website advertisement information, initiating the set up of a substudy and the selection of certain secondary outcome measures. The LEAP continuously ensured that the trial maintained a strong patient focus, providing recommendations for study design, treatment considerations and COVID-19 practicalities, in order to improve the research participant’s experience. They provided several different recommendations for promotion of the BRIGhTMIND study, which helped to enhance recruitment, and had significant input into the recruitment of research and TMS staff. Finally PPI was crucial for the analysis of the qualitative work, dissemination of publications and further recommendations for dissemination beyond that of academic papers.

A further strength of the LEAP was its heterogeneity (diversity of demographic characteristics, geography, and relevant experience). First, the PPI contributors ensured there was a strong service user focus, by viewing and providing feedback on issues or topics through the lens of their own experience. This also enabled the research team to deal with practicalities that may not have been highlighted without the PPI’s feedback. Second, the PPI contributors had various experience in the medical, mental health field and prior PPI involvement, and it was felt this led to more efficient outcomes and the ability to deal with a wide range of topics.

One suggestion for improvement could be the communications between each of the site’s research teams and their local LEAP representatives. While there was funding available for local PPI contributors to meet with their site RAs, and PPI contributors were eager to meet site RAs, this did not occur until midpoint through the BRIGhTMIND trial. The nurture of good interpersonal relationships is crucial for effective PPI involvement,189 and the PPI contributors recommended that introducing the site-specific researchers to the LEAP group at an earlier meeting could have been beneficial. As a result, future research should ensure that extra time, training, and funding is provided for both researchers and PPI members to maximise involvement and impact.190 In addition, expectations for communication, involvement, and responsibilities between study sites and PPI contributors should be clearly outlined during the set up of studies.

Conclusion

This chapter demonstrates that the PPI approach is suitable for the context of setting up complex multisite trials. The COVID-19 pandemic was a unique challenge, but it shows the robustness of such an approach in being able to adapt to the most extreme and unexpected challenges. Future complex trials may benefit from a comprehensive PPI plan at the grant application stage which would, for example, take into consideration how PPI members may have a blend in low, medium, and high involvement, the need for an experienced PPI lead, and the need for heterogeneity of PPI members.