Twelve months into a feasibility trial: reflections on three experiences of public and patient involvement in research

Knowledge scope

At one of these meetings, the PI said they had prepared the Patient Participant Manual for the study and they had a sample of the booklet. It was beautiful. For me it looked like something I would be proud to have in my bookcase or even on the coffee table. The way the manual was manufactured was excellent. As a person with MS for 28 years, however, looking at this as a tool for making the intervention more effective for the participants, I knew it was only fit for the bin. Of course, I shared my opinion with the team - highlighting that it would not lie flat on the table, the pages were too slippery, and the gloss made it difficult to see what was written on the pages.

It surprised the team. At no stage did they realise the document they had produced would not be suitable for people like me, and why should they? No one else had my lived experience. Even though they knew all about MS, its symptoms and prognosis, they never lifted a book with MS hands.

Once they recovered from the surprise, we got down to the secondary benefit of having the patient at the table - I could share what I needed to make the manual more suitable. Some of the things I suggested were the importance of the type of paper, the binding, location of the page numbers, font and spacing – plus extras like a pouch for loose pages and extra forms (just in case). We then shared this format, along with the original, with the Patient Advisory Panel. They agreed with my opinion and added a few more suggestions.

What a success and a perfect example of why research should have a patient or potential recipient of a new therapy involved at all stages of the research. The researcher doesn’t know what they don’t know; and it is only through having the input of someone with the lived experience at the table they will know if they are going down the wrong path.

Access to the community

At another meeting, we were discussing the recruitment of participants to the trial. This is always difficult, from what I am told, and when we had a small response to our initial press release, we began to talk about how else we can get in front of more people with MS.

Leaflets and posters in MS Society and GP offices was a start. Utilising my connection with a local radio station (Connemara FM), I did an interview about the study, my role in it and the type of people we needed. This brought in a few more people and revealed the power of the ‘patient story’. Subsequently, I used my connections within the MS community to get interviews with local and national press (e.g. Irish Independent, Irish Examiner and Farmers Journal, to name a few), as well as radio in areas we needed more participants.

The impact on recruitment was immediate. Within several weeks, we had enough to start the next stage of the trial and prepared to start the therapy. Why was this successful? I believe when you hear or read of someone who is going through a similar experience to your own, you form a bond, a camaraderie, which strengthens the trust you have in the message they share. I am one of them; and if I believe in it, then, perhaps, it will work for them, too.

Embedded patient collaboration

Imagine an architect only asking the user of the building when the structure is nearly complete, where to locate the light switches, meanwhile none of the doors are wide enough for the user’s wheelchair. The recipient of the product, service, or therapy must be part of the process.

Developing anything new, which should have a long and useful life needs to be a collaborative venture – with all the stakeholders at the table, sharing equal status. We need more than engagement or participation, as these are additions to research, and not essential parts of the process. We need to be collaborators; patients don’t want to be there just to tick the box – we want to be there from the start, taking part in every decision.

The COB-MS program is about to be delivered to participants and the new manual will be used, which we hope will show people receiving the intervention that the research team understands what it is like to have MS and our particular needs.

I have shared two examples in this letter of how patient involvement has altered the course of this study. Some were small changes – and others bigger; but each one demonstrates to the participants in the trial that we understand what it is like to have MS. Every action is looked at through the lens of someone with the illness, who knows the role it plays in their daily experience. The challenge is how to measure the impact of each one of these on the trial.

In the last few months, this trial has also had to face the complication of the COVID-19 pandemic and its impact on research. I am an active part of the MS community here in Ireland, as well as in the UK and USA. I knew since its arrival the impact it would have on our study. Delivering the intervention in person would be an immense challenge. Online delivery would be the only route for most people with MS, because of the increased risk for this patient cohort.

Based on this knowledge, the team started to prepare for the possibility of changing the delivery method. We met with the PPI Advisory Panel to get their opinion and they agreed with the change. Moreover, the panel shared its experience of online therapies and groups, which helped us design the new format. This was combined with recommendations made in past, relevant research regarding how to use online platforms like that we are now using to deliver the program.

Once again, because a patient is ‘at the table’, it is possible to pre-empt potential challenges. We are also invested in the project, as we need it to be a success; and so, we can also provide concrete recommendations on how to proceed. We want and need to be collaborators. There for every decision, ensuring the focus remains on the patient first, with the goal of a better quality of life for those who receive the therapy.

Challenges

In order to provide a balanced perspective of PPI in this project, it is useful to also mention any obstacles which had an impact on me and the research. As I am the first person to be employed in this type of role for the university, the induction process was not adequate. Even though there was an independent professional assessment of my needs, it did not translate into Human Resources putting in place the supports I needed to be effective in my role.

These included having a suitable office space, a location to store a mobility scooter and suitable chair, desk and computer. Some of these were resolved by the university and others were resolved by the pandemic and actions I had to take as an individual. Fortunately, I had the personal resources to resolve these, but this would not be the case for every patient and will act as an obstacle to effective PPI.

People who have chronic medical conditions, like multiple sclerosis, have financial support from the government. These payments link with access to medical support, such as the medical card in Ireland. If the role of EPR is paid, it could jeopardise these necessary supports, resulting in less involvement of patients due to this risk. This prevents a diverse range of people from being part of research, which will reduce the quality of the research.

Every team takes time to develop and form a cohesive whole. This team was no different. However, each team member wished to ensure the success of PPI in the trial. This desire to incorporate the patient in every aspect was led by the PI, ensuring the Patient Advisory Panel was used as often as required.

Challenges

Though I’ve always understood the potential benefits PPI could offer, I did have concerns upon hearing that PPI would be integrated within this research program; particularly, in light of conversations with researchers from other projects, as well as challenges PPI has presented me in some of my past research ventures. Primarily, I was concerned about how such involvement could impact the project’s timeline; and though that may be a reasonable concern in some contexts, what I strongly believe facilitated the successful implementation of PPI in our current research is the manner in which it was integrated. Our embedded patient researcher was involved in the research from the very beginning and was a part of a vast majority of the decision-making processes throughout the project’s life-cycle. Even when he wasn’t a part of it, he knew about it and the rationale behind it. If he had a problem with it, he would let us know quickly. Our embedded patient researcher works as part of the team, concurrently, which supports our timeline. To reiterate, I remain with concerns over having PPI integrated within research that I’m working on (given that the introduction of any additional consideration to a timeline could potentially lengthen it); but, that’s not as a result of PPI itself; rather, it’s down to the project’s design and how PPI is being implemented. If it is the goal of a researcher to integrate PPI within their project, I would highly recommend involving an ‘embedded patient researcher’ strategy, with someone who is there from start-to-finish and is genuinely involved, throughout, as a part of the research process.

The participant handbook

The content of the handbook (which details the intervention and acts as a manual for participants and occupational therapists delivering the COB-MS) was developed prior to the beginning of the trial. Part of the process of developing the handbook involved consultation with people with MS and occupational therapists (see Hynes & Forwell, 2019). Feedback and focus groups with key stakeholders were key to the development process- in this case occupational therapists and people with MS. With feedback obtained the handbooks were updated and formatted- two versions of the handbook exist, one for people with MS and one for occupational therapists delivering the COB-MS. I was then happy to get them printed off and ready for participants.

A sample of the handbook was brought to the research team meeting for approval. Time and thought had been put into the design and layout so I had not anticipated any issues with it. The researchers were happy with the handbook, but it was our PPI contributor, the embedded patient researcher (RJ), who immediately spotted a number of important issues that needed to be addressed before we printed the batch of 100+ handbooks for our participants.

Given the changes suggested, we decided to have a meeting with our wider PPI advisory group where we brought different handbook samples and discussed areas that needed to be changed or included in the final version. Attending that meeting very much solidified the importance of PPI in this feasibility trial for me. The changes that were made ensured that the intervention was more accessible for participants and showed that the research team had an awareness of what would help people participate fully. These issues would not have been spotted were it not for the PPI members on the trial. It can be difficult when you receive negative feedback on something you have designed and formatted but if the end result means that the handbook facilitates participation, and does not become another barrier then there is no doubt that it is worth it! Fostering a culture of openness and kindness within the group allows for these difficult discussions to take place easily. The handbook is now being successfully used by participants in the trial and informal feedback has been very positive. 

Participant recruitment

As we were recruiting participants, there were some geographical areas that we were finding it difficult to recruit from. We did a call through the MS Society and through the occupational therapists working in the area but were unable to recruit adequate numbers in some areas. Our embedded patient researcher decided to get involved in the recruitment process and took it upon himself to do interviews for radio and print media, with a specific focus on the difficult to recruit areas. Our wider PPI Advisory Panel also helped in suggestion where and how we might best target our recruitment in those areas. Having someone living with the condition talk about the COB-MS trial allowed people listening to hear the experience of someone living with the same condition and explain the research in a way that is meaningful and understandable to them. This effect on recruitment has been reported elsewhere with PPI interventions having a modest but significant increase the odds of participant enrolment (Crocker et al., 2018; Domecq et al., 2014). MS Ireland were key to successful recruitment and their networks allowed us to reach a wide group of people. The addition of recruiting through print and radio with EPR meant that we could reach people with MS who were not linked with MS Ireland, which was an important part of our planned recruitment strategy.

There are still barriers that exist to recruiting under-served communities in research and clinical research has for the most part failed to adequately address this issue. Involving PPI members from these under-served communities could be a way of trying to increase the diversity of our participants (Smits et al., 2020). The INCLUDE roadmap, developed by the NIHR (NIHR, 2020) provides an overview of the stages of the research process where researchers can act to include more diverse groups of people, particularly those defined as “under-served”. This is a goal that we have for future PPI work in MS.  There is a significant number of people living with various health conditions, including MS, that choose not to be a part of the associated organisation. It is important to develop ways of reaching these groups and allowing the opportunity to participate in research. We, in the COB-MS trial, acknowledge that this is an area that we need to do better in, but we are working towards this, and have incorporated this into our dissemination plan.