Implementing patient and public involvement in research: Q&A with Dr Joanne James 23 Jun 2021
Patient and public involvement in research is increasingly regarded as best practice. Whilst often viewed (and given lip-service) as a requirement for funding, there is much more to it than that. In this Q&A article, we interviewed Clinical Development Consultant Dr Joanne James to discuss her perspectives and experiences of these important initiatives.
What is patient and public involvement in research?
Patient and Public Involvement (PPI) ideally works as an active partnership between the public and researchers. It encompasses collaboration with patients and the public to plan, design, execute and finally communicate research. Practically, this can be via workshops, meetings or “mailed” questionnaires. Public involvement is where members of the public are actively involved from an early stage in research design and conduct; Public engagement is involvement in the process of communicating research findings to the public.
I became aware of the concept of PPI around 12 years ago during my early clinical research work, when I was invited to pitch our novel clinical study to a patient advocate group. INVOLVE, a national advisory group to support patient involvement objectives, was established in 1996- so the concept has a long track record. However, over the last few years, the topic of patient and public involvement in research has come increasingly to the fore and is also increasingly required. In April 2020, the NIHR Centre for Engagement and Dissemination took over responsibility for the work of the INVOLVE advisory group.
What is the benefit of patient involvement?
Listening to patients from the outset and incorporating their views, enables better research. It has become viewed as hugely beneficial to work in partnership with patients to clearly outline the planned research and the expectations it will place on them. Patient input into understanding which procedures are necessary and which place unrealistic burdens, ultimately not only simplifies and improves research protocols but also reduces withdrawal or dropouts.
Patient advisory and advocacy groups are key stakeholders as part of this process. Patients volunteering as part of an advisory group are usually either undergoing treatment or have had treatment in the past, and caregivers also play a significant role in contributing their perspectives. They report that it can help them to feel involved in their treatment plans, or that they are happy to “give something back”.
Their role can comprise input into protocol design, such as deciding what treatment visits are needed and reviewing patient-facing documents, to helping to disseminate results in an understandable manner. Unfortunately, patient-facing documents are not always sufficiently accessible, so they benefit from patient input.
What makes good patient communications to underpin patient involvement?
Good communications should be ongoing, clear, and consistent. As part of their remit, the Research Design Service of the NIHR provides advice on public involvement, and patient advocacy groups also tend to be exceptionally strong at giving this type of advice. Interestingly, patient anecdotes indicate that in some way COVID has opened up this experience and facilitated better communication.
Whereas in the past an all-day face to face meeting with the research sponsor might have been limited to those who could physically attend, virtual meetings make involvement possible from the patient’s own home, allowing others to take a more active role in the process.
What improvements do you think are needed?
Over the last few years, in designing trials, I have been firm from the outset that we need to actively engage patient groups, to make our studies as efficient as possible.
Typically, trial sponsors work closely with advisory groups of clinical “Key Opinion Leaders”, but it is also necessary to engage with patient groups and, where relevant, end-user groups such as nurses.
Engaging as early as possible and continuing to engage throughout is critical. It is important to plan carefully and make it easy for patients to attend meetings, then ensure regular follow up to close the loop and thank them for their participation and comments. Getting these basic principles in place ensures that the patient view is sufficiently represented.
What will be the impact of better public and patient engagement?
The impact of public involvement is the long-term benefit and learning gained from the patients’ carers’ and the public’s insights and experiences. It is the streamlining of clinical development, determining the critical issues from the “nice-to-haves”, understanding study logistics and feasibility, towards improving recruitment and ultimately, cost efficiencies. We must listen to patient experiences and take them on board- not simply as a “tick-box” for funding requirements but because it is what patients tell us they need.
About Joanne James
Dr Joanne James is an award-winning Clinical Development Consultant with a proven innovation track record across medical devices/pharmaceuticals.
She specialises in SME/ start-ups, developing academic/commercial/NHS partnerships, product development, patent defence, design/planning and approvals of clinical studies. She has more than 25 years of experience in translational medicine across broad clinical indications including wound care, diabetes, vascular and inflammatory diseases.