Increasing patient and public involvement in clinical research
Authors: None The Lancet Healthy Longevity
Journal: The Lancet Healthy Longevity (2024)

Clinical research is vital for improving human health. However, multiple issues, including research aims misaligned with the needs of patients, non-representative participant recruitment, and a failure to disseminate results effectively, all reduce the impact of research. Patient and public involvement (PPI) can be a powerful tool in ensuring that research focuses on the most pressing needs of a population. Older adults, often underrepresented in clinical research, are a group that can particularly benefit from PPI. Direct input into study design can reduce and remove barriers to participation, for example, by increasing support for the use of digital technologies or minimising travel to study sites to allow those with reduced mobility to participate. As health services attempt to move towards more holistic, patient-centred care, PPI in research will be more vital than ever. PPI, also known as patient engagement, is the active involvement of patients and the public alongside researchers in clinical research. Guidance, such as the UK Standards for Public Involvement, make it clear that involvement cannot be tokenistic but must involve true collaboration. This month's issue of The Lancet Healthy Longevity includes the BASIL+ randomised controlled trial. In the trial, Simon Gilbody and colleagues studied behavioural activation to reduce depression and loneliness in older people during COVID-19 restrictions. The researchers worked with an advisory group which included older adults with lived experience of mental, physical, or both health conditions and their caregivers. The advisory group was involved in recruitment strategies and delivery of the intervention, including how to support technology use in participants. In this month's linked podcast a member of the advisory group highlights that the group's involvement in the study “never felt like a tick box” and that the advisory group members’ opinions were valued and listened to. Similarly, and also included in this issue, the NIDUS-Family trial had substantive PPI. Claudia Cooper and colleagues studied an intervention designed to increase independence by attainment of personal goals in people with dementia living at home. As detailed in the study protocol, people with personal or caring experience of dementia were involved in many aspects of the study design. Increasing evidence supports the benefits of PPI. Results from a meta-analysis found that PPI can increase the odds of participant enrolment in clinical trials. It can also build trust between participants and researchers, a crucial step for ensuring participation of underrepresented groups. The 2023 Alzheimer's Association International Conference, which welcomely held a session on PPI, included a talk on adaption of a cognitive assessment tool in a Brazilian indigenous community. The researchers used cultural-centred steps to build and maintain the involvement of the indigenous community in the design and recruitment of the study. An example from the HIV community demonstrates the benefits of this type of involvement in disseminating results, in this instance complex results from a community-based randomised trial. The trial included community advisory boards comprised of members of each geographic community involved, who played a role throughout the entire research process, from trial design to the creation of a trial exit plan. A community dialogue approach was used to disseminate results which proved a popular and useful approach. At a time when the COVID-19 pandemic has highlighted the dangers of medical misinformation, the importance of dissemination of research findings to those who would benefit is greater than ever. Many funding bodies and research agencies now provide tools and guidance to help researchers build PPI into their research proposals. Additionally, some funders take PPI in grant proposals into account. For example, the Alzheimer's Society include “appropriate participation of people affected by dementia” as one of four areas scored to determine which grant applications are successful. The approach is one that hopefully all funders will move towards. PPI should be considered a vital component of clinical research. Research that fails to consider the needs and the priorities of the population it is designed to help is a wasted opportunity. For older adults, who are large consumers of health care and are a very heterogenous population, tailoring research design is particularly vital. More research is needed to quantify the benefits of PPI and to further develop best practice and tools to support researchers in achieving active and meaningful PPI. Health involves us all and can only be strengthened by this type of involvement. Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trialBehavioural activation is an effective and potentially scalable intervention that can reduce symptoms of depression and emotional loneliness in at-risk groups in the short term. The findings of this trial add to the range of strategies to improve the mental health of older adults with multiple long-term conditions. These results can be helpful to policy makers beyond the pandemic in reducing the global burden of depression and addressing the health impacts of loneliness, particularly in at-risk groups. Full-Text PDF Open Access