Engagement and retention of Patient and Public Involvement (PPI) contributors in cancer clinical trials – a scoping review protocol

Background

Patient and Public Involvement (PPI) is research done with or by patients and the public, not to, about or for them¹. PPI involves a range of activities that allow patients and the public to contribute their perspectives, experiences, and insights into the design, delivery, and evaluation of health services^1,2.

The origins of PPI in healthcare decision-making can be traced back to the 1980s, when initiatives began to emerge to incorporate patient feedback into health services planning^2,3. By the late 1990s and early 2000s, PPI had become formalised, particularly in the UK, where the establishment of INVOLVE in 1996 marked a significant milestone⁴. INVOLVE provided guidance and frameworks for incorporating patient perspectives into National Health Service (NHS) research^2,3. The National Institute for Health Research (NIHR) made PPI a core requirement for funded research, further establishing its role in the research process².

In cancer research, PPI has evolved from minimal involvement to a more integrated approach, where patients actively contribute to shaping research agendas^5,6. There has been a marked increase in PPI activities during the early stages of cancer research, reflecting the growing recognition of its value in informing research directions^5–7.

PPI offers numerous benefits, including enhanced relevance, quality, and credibility of research, which leads to more robust and applicable findings^8,9. It also enhances the ethical conduct of research, ensuring that studies address real-world patient concerns and issues⁴. This involvement improves patient choice, self-care, and shared decision-making, crucial elements for patient satisfaction and better outcomes¹⁰.

Another benefit is the innovation that PPI brings^7,11,12. PPI contributes to the identification of relevant research questions and outcomes, which can significantly influence the effectiveness of clinical trials^11,13. When patients are engaged in the research process, they can provide insights that help shape the study's objectives and methodologies, ensuring that the outcomes measured are meaningful to them^14,15. PPI helps also ensures that research findings are communicated in a way that is accessible and meaningful to the broader public, leading to faster uptake of new treatments and practices⁸.

Importance of engagement and retention

Effective engagement and retention of PPI contributors is critical to ensuring their meaningful involvement throughout the clinical trial lifecycle^2,4,11,16. We know that trials engaging only a small number of PPI contributors, leads to feelings of marginalisation and tokenism^8,17. The sense of tokenism can result in contributors feeling that their input is neither valued nor impactful, discouraging their ongoing participation and retention^8,10,17. Effective communication and regular feedback are shown to be crucial for retaining PPI contributors as they motivate them for further involvement and support their learning^4,16,18. However, how effective communication might be conducted is unclear. Lack of recognition and compensation for the time and expertise of PPI contributors may act as a barrier to their retention^15,19. Many contributors feel undervalued when their contributions are not adequately acknowledged or compensated^19,20.

Previous research has shown that PPI contributors who are involved in responsive and managerial roles, such as membership in Trial Management Groups (TMGs), tend to provide greater benefits to the trial compared to those in oversight roles, such as Trial Steering Committees^4,7,11. Evidence suggests that when PPI contributors are part of decision-making processes, they develop a sense of ownership and relevance, which significantly enhances their engagement and motivation to contribute meaningfully throughout the trial^4,7,12.

Productive working relationships between researchers and PPI contributors have also been identified as crucial for effective engagement^13,16,18,21. Strong partnerships foster mutual respect and understanding, which impacts how contributors perceive the value of their involvement^2,4,18. Additionally, challenges persist in involving patients with lower education levels in trial development, highlighting the importance of understanding diverse perspectives in PPI activities^18,22,23.

While previous research has identified some strategies and barriers that affect the engagement and retention of PPI contributors in clinical trials, the underlying reasons remain poorly understood^13,20,21,24. Currently, there are no well-established strategies for maintaining PPI involvement, and while training is recognised as essential for both researchers and contributors, the interest for such training remains limited, particularly among PPI contributors^13,25,26. Feelings of tokenism and marginalisation among PPI contributors can discourage their ongoing participation^2,8,23, but the precise mechanisms that lead to disengagement are not fully explored. Effective communication is highlighted as crucial for retention⁴, but there is a lack of understanding of how different communication strategies can be tailored to meet the diverse needs of contributors, especially those from marginalised backgrounds^10,23. Compensation is recognised as vital for acknowledging the contributions of PPI members^2,19,21. Understanding these gaps and strategies for engagement and retention strategies is essential for optimising PPI and realising its benefits^2,4,11,16. While previous reviews have broadly covered the application and reporting of PPI in cancer research, they did not assess the specific methodologies used and challenges identified in engaging and retaining PPI contributors^5,6.

For the purpose of this scoping review, we will adopt the definition of PPI as "research done with or by patients and the public, not to, about, or for them¹." This definition includes the active, collaborative role of patients and the public in research. The engagement and involvement refer to the active and meaningful participation of patients, carers, and members of the public in the planning, design, conduct, and dissemination of cancer clinical trials.

Objectives

Methods

The scoping review will adhere to the guidelines and framework by the Joanna Briggs Institute (JBI), which represents the most recent framework for conducting scoping reviews²⁷. Unlike other frameworks, the JBI framework offers a more structured and comprehensive methodological approach^28–30. The framework consists of nine steps:

The research question is: "What are the strategies used to engage and retain PPI contributors in cancer clinical trials?".

Ethics and consent

Ethical approval and consent were not required.