I have been involved in Patient and Public Involvement and Engagement (PPIE) for several years and have seen a marked evolution in that time.

Initially, any approaches I had to be involved in research as a patient almost universally involved reviewing the lay summary of a study that was ready to start or had even been completed. This really is PPIE ‘light’ and reflects the now outdated view of the patient as nothing much more than a ‘willing recipient’ of a clinical study.

A more modern approach recognises the real value that can be gained by partnering with people who have lived experience of disease. For that reason, in this piece, I will address patient rather than public involvement. These are really two distinct approaches and would be used in different circumstances. It’s also important to note that that when thinking about patient involvement to gain lived experience insights caregivers should also be included as they can be the primary sources of information in many cases.

I was involved in a study which serves as a good example of this evolution. Carried out in Scotland, the study brought together the disparate databases of colorectal cancer patients into one dataset that could then be interrogated to assess care. When the research team approached me, it was to review the lay summary of the final paper which they were aiming to submit imminently, the work had all been done. I dutifully reviewed the lay summary and went through the whole manuscript to ensure the lay summary was a true reflection of the paper. I went back to the team with a few notes on the lay summary and a few comments on the main manuscript, including challenging some of their conclusions and adding to the next steps. To their credit, they came back to me quickly, were very open to my input, redrafted the manuscript to include all my points and asked to add me as a co-author.

Since then, I’ve been involved in a number of projects based at that same university and have been brought in at the beginning of their study process to truly co-create their work. They now have a patient-lead and a PPI panel in all of their proposals.

Making it relevant

This approach has been successfully used in a number of clinical studies I have been involved in too. Often, I am asked to give my opinion on a study that has an initial draft protocol, whilst not true co-creation, this is a good stage to bring the patient in.

I should say that in my experience it’s rare that patients would challenge or want to change the primary outcomes in a research proposal, but the value we can bring is looking at secondary outcomes and the practicalities of a protocol from the perspective of the participants. By getting patients to identify the secondary outcomes it ensures that the study produces data that is truly relevant in the real world, rather than solely answering a research question. This then helps the study inform clinical practice more effectively, and potentially also be of value for Health Technology Assessments.

The practicality or acceptability of a protocol to a patient is critical to ensuring that patients will be willing to contemplate being involved in a study, or once recruited, are willing to stay the course to completion.

Recently, for example, I worked with a team on a draft protocol which involved patients undergoing one or two additional colonoscopies. That does not sound much and would have been easy to miss in the protocol. However, as any patient who has had to undergo that procedure can tell you, the preparation is, to say the least, unpleasant. When I highlighted this on the PPI group my fellow patients all agreed, this would be a definite barrier for many patients. The study team and I discussed the issue and found that for most patients a flexible sigmoidoscopy would be adequate, this is something that is a lot easier for the patient and would therefore be far more acceptable.

By involving patients in the design of this study they avoided what could have been a significant barrier and would almost certainly have required a protocol amendment when the study was underway, therefore improving efficiency and reducing the study costs.

It’s not just study design…

Every study team I have been involved with agrees on the value of involving people with lived experience in the design of the study. They have seen how it has improved the quality of their work and have been keen to involve patients in their subsequent research.

And the involvement of patients should extend further than just study design. There are also many benefits to involving them throughout the study cycle, including developing both patient- and healthcare professional-facing materials, reviewing interim results (and any changes that may be needed), receiving and interpreting the final results, drafting the manuscript and presenting the data.

Many patients are not just willing but keen to be involved in research. We see it as a way to make something positive out of our experience, and to try to improve care of our fellow patients in the future.

My advice is to see patient involvement as so much more than a requirement to the get a research grant, truly integrating patients in research can add value and improve quality, keep you focussed on patient benefits; motivate you; reduce protocol amendments and reduce enrolment time.