Overview
This section provides an overview of PPI in PATHWAY, demonstrating how PPI was integrated throughout the study. A detailed overview of our PPI framework and how this compared with NIHR PPI standards has been published.27
Involvement in grant development
Although the study idea was generated by members of the research team, prior to submitting the grant proposal, links were formed with local charity organisations such as the Ticker Club at Wythenshawe Hospital. In developing the grant application, 30 service users across two cardiac service groups were consulted on the preliminary research ideas, the acceptability and feasibility of the proposed research within services and plans for PPI.
Forming the advisory group
To ensure that our patient advisory group comprised a range of service users with varying experiences, we recruited from multiple patient networks, including Salford Citizen Scientist, the Ticker Club and Salford Heart Care, and asked that they had experience of one or more of the following:
- Heart disease
- Psychological distress (anxiety and/or depression)
- Caring for someone with heart disease and/or psychological distress, including professional carers
Sixteen individuals expressed an interest in joining the group; 13 of these attended an initial meeting, and 10 went on to form our patient advisory group. Table 3 gives the demographic characteristics of our PPI members.
| ID number | Gender | Age at beginning of study (years) | Ethnicity | Marital status | Qualification | Are you a CR service user? | Do you have experience in research? | Do you have experience as a PPI member in other research studies? |
|---|---|---|---|---|---|---|---|---|
| 01 | M | Not disclosed | Not disclosed | Married | Not disclosed | Y | N | N |
| 02 | F | 70 | Black African | Divorced | Degree | N (mental health nurse) | Y | Y |
| 03 | F | 53 | Black | Divorced | Degree | Y | Y | Y |
| 04 | M | 67 | White background | Married | Vocational qualification | Y | Y | N |
| 05 | M | 69 | White British | Married | Vocational qualification | Y | N | N |
| 06 | M | 61 | White British | Married | Diploma | Y | N | N |
| 07 | F | 65 | White British | Married | Degree | Y | Y | No |
| 08 | F | Not disclosed | Not disclosed | Not disclosed | Not disclosed | Y (carer) | Y | Y |
| 09 | M | 63 | White British | Married | Degree | Y | N | N |
| 10 | M | Not disclosed | Not disclosed | Not disclosed | Not disclosed | Not disclosed | Not disclosed | Not disclosed |
Over the next 5 years, three members left, the most common reason being ill-health. When consulted, the advisory group felt that this was to be expected due to the length of the study and the health of the membership and highlighted that that it would not be helpful to re-recruit to the group due to the complex nature and the duration of the project.
Structures and processes
Patient and public involvement meetings took place two or three times per year to provide feedback on and insight into various aspects of the trial. Initially meetings were face to face but during the COVID-19 pandemic these were changed to online meetings using Zoom (Zoom Video Communications, San Jose, CA, USA). Group members were provided with additional opportunities to contribute throughout the study by e-mail or telephone, allowing choice and flexibility of approach and opportunity.
The PPI lead developed and oversaw all aspects of involvement and worked in collaboration with the advisory group and research team to ensure a shared understanding and that everyone’s needs were met.
The advisory group included a chairperson to represent the group and to provide an additional point of contact for any concerns they wanted to raise. The chairperson attended the executive committee along with the PPI lead.
A PPI member independent of the research team and advisory group was also appointed as a member of the TSC.
All service users were reimbursed for their time and travel expenses, in line with INVOLVE guidelines.
Service user involvement throughout the study
Patient and public involvement was integrated throughout the lifecycle of the study and in all WSs, including the stated preference survey, with the degree of involvement and contribution altering throughout the research process. Figure 7 shows an overview of PPI throughout the study.
FIGURE 7 Overview of PPI throughout the PATHWAY trial. Reproduced with permission from Capobianco et al.27 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The figure includes minor additions and formatting changes to the original figure. (Figure not reproduced here; see the original article.)
The advisory group’s insights ensured that the language in our patient-facing documents was appropriate and that any likely concerns or questions had been addressed. For example, the group said that an explanation was needed of what to expect from the home-based manual and what to do when it arrived. They also suggested we give a simpler explanation of how to complete the homework sections and emphasise that the modules should be worked through at the patient’s own pace.
Asking group members to pilot the psychological therapy (home-based manual) not only allowed us to modify the timing and content of phone calls, but also provided them with greater knowledge of the intervention and participant experience that they used to inform dissemination activities. For example, advisory group members noted that it would be interesting and engaging to try to incorporate some the techniques in the manual into dissemination workshops and presentations.
The group’s suggestion of a newsletter to provide updates on the study, remind participants of its importance and highlight the impact of returning questionnaires was an important factor in improving our rate of return on follow-up questionnaires.
The group’s input also informed the designs of the stated preference studies, including choosing and defining attribute and levels, and revising survey materials. For further details of PPI involvement in the stated preference survey, see Shields et al.20 The PPI activities were used as a case study on a paper exploring PPI involvement in stated preference research.
Our PPI group also co-developed the dissemination and impact plan and dissemination materials prior to the COVID-19 pandemic. Our PPI group helped us to modify our dissemination and impact plan, which was reduced because of the pandemic. This included identifying key messages, audiences and channels for dissemination, and co-creating dissemination materials (i.e. videos and blogs about personal experiences). They also suggested that we ask members of the Ticker Club to evaluate our first patient-facing presentation and suggest other potential audiences for dissemination (see Appendix 5).
Our PPI group was involved in co-delivering the dissemination activities. For example, on 15 July 2021, we held an online dissemination event for patients, members of the public and clinicians. The dissemination event was developed in collaboration with our PPI group, and one of our PPI members was involved in discussing their experience along with a study participant, which provided a patient voice and highlighted the study’s importance and benefit.
Impact on the advisory group
The advisory group members each completed a questionnaire to assess the personal impact of their involvement (see Report Supplementary Material 1). Members agreed that taking part had given them an opportunity to use their skills and make a difference and meet people who had experienced similar things, given them more hope that people will be supported in the future, increased their understanding of how research works, and improved their understanding of coping with anxiety and depression and their own ability to cope with mental health needs. One advisory group member reported:
I think it’s great that psychological, the emotional side is now being sort of trying to be managed because it’s not been there … I didn’t know until we started getting the paperwork what it was [anxiety and depression] … and now I know why I didn’t want to go out of the house for 6 months. I never ever suffered with depression before, but I now know why.
They concluded that it had been an enjoyable experience, it had increased their trust in research and researchers, and it had made them more likely to discuss research with friends and family. Comments included:
I have gained a better understanding of all the difficult decisions that researchers have to make … The opportunity for the future looks promising and will certainly help more participants to cope.
It has been a fulfilling experience. Too often patients’ views are not taken into account. I felt that we were listened to at every stage of the research and our suggestions were treated with respect.
Although no negative impacts of participation were reported, one member had been unaware that they were eligible for transport to the venue by taxi and undertook quite a challenging journey until the research team became aware of the situation.
INVOLVE standards and suggestions for future patient and public involvement
The advisory group’s regular evaluation of our PPI approach, including their review of our approach against the INVOLVE national standards (see Figure 8), highlighted various challenges in achieving the standards. Below we discuss the main challenges and solutions, and the advisory group’s suggestions for the future.
FIGURE 8 Overview of PATHWAY trial implementing INVOLVE PPI standards. (Figure not reproduced here; see the original article.)
Understanding of research
Although the advisory group ultimately felt that sufficient information had been given, at times confusion about some of the processes and protocols and unfamiliarity with the psychological intervention in question (MCT) had resulted in feelings of being underused.
For example, members suggested that the wording of the standardised questionnaires could have been contributed to low return rates and noted that they had not been consulted on this before the questionnaires were sent out. They were also keen to encourage the public and funder to promote the implementation of MCT in CR programmes, which was a premature suggestion as they were unaware that further research into this area would be needed first. The belated explanation of MCT was also highlighted as a barrier in the early stages of involvement. One member commented:
When we first started, most, possible all of us didn’t understand the nature of the actual treatment. It was quite a long way down the line before we saw the materials … and understood more about how the treatment would work. I think some training earlier on in the process would have put us in a position where we were better informed to contribute.
The group agreed that a workshop on the wider research process at the start of the project would have been helpful. We suggest including (1) what can and cannot be changed in a study and why (2) setting realistic expectations for roll-out and study impact, and (3) a clear explanation of the intervention, including a chance to trial or watch a demonstration of it.
Working together
Towards the end of the study the group felt that the varying types of communication (group-based, one-to-one, e-mails, telephone calls) was sufficient and the level of language and approach was effective:
What has been done well overall is that communication has been excellent.
However, it was suggested that further consideration be given to supporting those who find group settings challenging; for example, some might feel pressure to agree with the majority of the group or have concerns around re-joining the group after missing meetings. One member recalled that on returning after missing meetings they felt like things had changed, leaving them overwhelmed and unsure of their role.
The group suggested that a returning PPI member and the PPI lead meet to discuss changes and progress prior to the next meeting, along with the returning member being reminded that they could contribute ideas on a one-to-one basis before or after the meeting.
Conclusion
Patient and public involvement had a positive impact throughout the lifecycle of our study and across the varying components. It also had a positive impact on the advisory group members who took part.
Our approach to PPI was felt to be effective by our advisory group and was aided by the process of ongoing evaluation and adjustment. Several key learning points have emerged that will inform our practice in the future.