Involving patients in the research process

Involving patients in the research process

Patient and Public Involvement (PPI) is defined as research that is carried out “with or by” people with the studied condition and/or members of the public. Other terms include Community and Consumer Engagement, and Patient Partners. PPI aims to improve the ways in which research is prioritised, conducted and disseminated, by promoting partnerships between the patients, the public and researchers. The ultimate aims of these “co-production models” are to improve the quality and relevance of healthcare research by drawing on the expertise of patients, carers and members of the public with lived experience of a medical condition or accessing healthcare services. PPI also allows for increased public accountability and democratisation of medical research which is often publicly funded. Furthermore, the increasing adoption of PPI has been bolstered by large funding agencies such as the National Institute of Health Research (NIHR) mandating active PPI integration as a prerequisite to trial funding, and establishing core infrastructure for PPI through organisations such as INVOLVE, PCORI and the Research Design Service.

There is emerging evidence that PPI is associated with a positive impact on all stages of research including increased trial enrolment, greater use of patient-reported outcomes, development of user-friendly assessments and interventions, and more patient-focused data interpretation and results dissemination.

There are several key considerations for researchers when planning PPI:

Although PPI can occur at any stage of a research project, best practice is to start planning and establishing links with relevant parties early in the process. Patients and members of the public can be involved in any of the following stages:

  • Funding and commissioning
  • Designing and planning
  • Undertaking and analysing
  • Disseminating
  • Implementing and evaluating
  • Identifying and prioritising the research question

Further details for each of these stages can be found at PPI Research Hub (Imperial College London)

Reaching out early to interested patients or groups is vital. Patients can be approached directly from clinics and invited to participate, or researchers can liaise with patient support groups, community groups or relevant charities. Advertising can also be undertaken through research networks, local newspapers, and social media (Facebook and Twitter). Funding organisations such as the NIHR have a Research Design Service which provides further advice on PPI engagement routes.

Any of the following can be involved:

  • Patients
  • Members of the public
  • Carers or family members
  • Parents
  • Members of the public affected by the health condition or intervention
  • Patient support groups
  • Charities that represent a specific health condition

Prior to inviting PPI, researchers must carefully consider the goals of public involvement in the research project, the expectations and whether they are reasonable, and also the skills required to be a competent patient representative, including the need to provide training to enable members of the public to understand research terminology and methods. Several organisations have now commenced face-to-face or online PPI training courses (NIHR, PCORI, European Patient Ambassador Program Course) for PPI contributors with sessions on the roles and responsibilities, research cycle, participant information documents and consent and considerations when reviewing research proposals (see links below).

There are also tools and courses to train researchers in PPI covering practical issues including recruitment, payment, setting up meetings, as well as good chairing and communication.

Being a PPI contributor often requires a substantial amount of energy and time, and can be costly particularly in those with long term conditions. It is therefore important for researchers to consider this impact and offer reimbursement for loss of income at work, travel, accommodation, time and childcare. Reimbursement is a means for recognising, valuing and respecting the contribution of patients or the public and allows recruitment of a more diverse group of PPI participants. Some agencies such as INVOLVE provide guidance on the level of payment which also includes a payment calculator allowing researchers to cost for PPI when applying for funding. When considering the number of PPI contributors to involve, it is important to consider factors such as peer support and the potential for PPI contributors to have unexpected health issues.

Evaluating the impact of PPI is important and there are several validated tools for doing this including Public Involvement Impact Assessment Framework (PiiAF) and Guidance for Reporting the Involvement of Patients and the Public (GRIPP). Although the evidence base for PPI impact continues to grow, more research is required, and there remain some controversies over the definitions of “involvement” and “impact”. Nonetheless evaluating the level of PPI and the effect of this on quantitative outcomes such as funding success, speed of ethical approvals and recruitment rates as well as more qualitative outcomes remains vital in maximising PPI benefits in the future.