The 5 I’s of Patient Involvement: Planning for Success

Guest Post by Robert Joyce

Researchers want their work to be relevant and of value to the patient community. This has been a goal since medical research started, but it is only in the last few decades that research has started including the patient. This has taken many forms, from focus groups to including a patient as part of the research team.

In 2019, I started training as a Patient Expert with EUPATI, and after my 18 months of study, I am now an EUPATI Fellow. This education taught me all about the research process and the ways patients like me – I have several chronic illnesses – can be part of this process. This organisation has also developed training for researchers on how to be more inclusive.

Since I started my advocacy, I have been a participant in some trials, an Embedded Patient Researcher and a member of several advisory panels for academic, commercial and governmental organisations. I have experienced both good and bad methods of Patient & Public Involvement (PPI).

Research benefits from effective patient involvement. Some benefits are:

• Relevance: The research question addresses the needs of the patient.
• Efficient: Patient involvement leads to less wasted effort
• Cost effective: The development of suitable material and methods from the outset
• Dissemination: Sharing the results with the patient community through engaged patients
• Recruitment: Access to a more diverse pool of patients, through patient networks

You can see a presentation I did with my colleague, Dr. Sinead Hynes, about the positive outcomes of PPI here. 

Researchers need to know how to include the patient voice more effectively, and often they ask me how to achieve positive collaboration with patients. They fear they will make a mistake. PFMD and IMI-PARADIGM are organisations which have many resources online, and are where I refer people who want to take PPI seriously.

To make the process of collaboration easier, I have created the “5 I” method. 

The 5 I’s of Public & Patient Involvement

Here are the five steps you can take to use the lived experience of the people who will ultimately benefit from a successful study.

1. Include

The first step is to include people who live with the medical condition you are studying in your project. This can be a panel of patients, an Embedded Patient Researcher or focus groups. The process of selection depends on the role. An advisory panel should be diverse, representing the various stages of the illness being studied and the diversity of the population. An Embedded Patient Researcher should be able to represent this diversity. That is a challenge, but it is possible. They don’t need to be a researcher, but have an ability to highlight the obstacles the participants could have with the question, protocol, materials etc.

2. Inquire

You must ask for the input of the patients you have selected. This should occur continuously throughout the research process. Prior to starting this, the researcher must ask what support this individual or group needs to be most effective. Illness expresses itself in different ways and the researcher cannot assume what is required. Patients will let you know what they need and this will start building the trust required for a positive relationship.

3. Innovate

Clinical research is all about finding solutions to patients’ problems. The patients you have engaged to be collaborators in your trial will expose areas in your question, protocol or methods, which will need to be adapted to be more suitable. This is a fantastic opportunity to create innovative solutions. This is not a process the researcher should do on their own. Discuss with your patient advisors the solutions they propose, and keep asking why this will be more effective than the original proposal, until you get an optimal solution.

Webinar Slide Deck: Patient Centricity in Clinical Research

In our previous webinar, we showed you how to optimise patient centricity in clinical research:

• Best practices for putting patient needs and expectations first
• The benefits you can achieve through patient-centric research practices
• New ideas together with other industry professionals

Get Slide Deck

4. Implement

The next stage is to implement these changes. By engaging with patients from the start of the process, they will highlight changes required in the drafting stage, resulting in fewer changes occurring during the study. If you have already started the study, and changes are required, this can cause costly delays, as you might have to get ethical approval for the change. It is also important for the patient advisors to see the changes. This builds trust.

5. Iterate

Throughout your study, you will need to cycle through these steps continually. Inevitably, during a study, you will come across issues which are not expected (such as the recent COVID-19 pandemic) which will need to be addressed. This process will ensure you have a smoothly running study.

Final thoughts

This is a simple set of rules to follow when planning the inclusion of patients in your research. Finding patients to be involved can be a challenge. The first step would be to contact relevant patient organisations for the disease area. Another way of accessing patients is online, including various social media platforms. Ask to join some groups, interact and ask questions. The community will appreciate you meeting them in their place. 

We need to see patients and researchers as part of the same team, with the common goal of improving patients’ quality of life. We want to help!