Patient and public involvement in research

PPI is now a necessary and indeed a critical component of all aspects of the research process including development of the research hypothesis, a mandatory requirement in grant applications, monitoring of research activities- recruitment and follow up, data collection, dissemination of research findings and implementation of those findings into clinical practice. There is an ethical and moral conceptualisation for involving service users in research in respecting patients autonomy, enhancing beneficence, and non-maleficence, and observing justice in all encounters including meaningful research participatory relationships (Parekh & Ali 2015; Beauchamp &, Childress 2001). For those working in the clinical arena who are often involved in translational research bringing research outcomes into practical benefits for patients, PPI is not a new phenomenon. For years many have probably had informal PPI in their research programmes. However this has now become more streamlined; for example it is customary for many funders to ask formally during the grant application process for an explicit statement about how projects can impact on health outcomes within a time frame after project completion and the explicit role of PPI within the research. Indeed funding bodies often involve PPI members in the initial grant evaluation process and funding decisions.

Many readers will be familiar with INVOLVE, which was established in 1996. This is part of, and funded by, the National Institute for Health Research (NIHR), to support active public involvement in NHS, public health and social care research. It is one of the few government funded programmes of its kind in the world. INVOLVE defines public involvement in research as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. INVOLVE defines ‘the public’ as including patients, potential patients, carers and people who use health and social care services as well as people from organisations that represent people who use services.

Role of PPI in the research process

The most useful way to consider this is to look at the pathway and components of a successful research proposal. PPI can input directly or indirectly into many stages of this process. While for some funders this may vary slightly, there are certain generic aspects. These are shown and discussed below. PPI involvement in research has been the subject of a systemic review (Brett et al. 2014). This useful article describes both the benefits and challenges and is referred to under the headings below.

• Initial proposal consideration. There is usually an idea around a clinical problem/ disease area (a hypothesis) that needs to be tested in a specific research trial. Preliminary discussions/ informal discussions can then start witha local established PPI group or with an organised group from a national society.

Priorities

Background to proposal/priority area specified in grant call

The focus of the research question (hypothesis) is determined by a regional or national priority.

These priorities are often dictated by consultation processes. Determining these priorities may originate from charities or patient groups or be driven by government agendas. In the case of charities there may be no specific priorities other than research into different aspects of a disease particular to that charity such as The Stroke Association or Parkinson’s Society. It is easy to understand and appreciate the influence of PPI into the process of establishing/ developing, priority areas or identifying areas that are under-researched. The PPI group can provide pragmatic criticism of the research protocol.

• Literature review/consideration. It is often useful when a literature review is complete, and before the research activity begins, to arrange a meeting with a PPI group to discuss the direction and agenda of the research proposal. This helps to ensure that researchers are on the right track from a PPI perspective; i.e the researchers are asking the right questions that the patients and public are interested in.
• Hypothesis generation. The formulation of a final hypothesis is the job for the researcher(s) but there can be a benefit in having that hypothesis iterated following an inclusive approach of consultation with patients and public representatives.
• Lay statement (critical for all applications but for charitable funders in particular). This is one very definite area where PPI can make a huge difference in describing the research hypothesis and objectives using lay language as researchers tend to use medical jargon. It is very useful to have a PPI group review the lay statement – as they are after all a similar group to those lay people who will be reviewing the grant applications, and a poor lay statement can seriously jeopardize the chances of successful funding.
• Protocol change/iteration. When it comes to protocol development, editing and iteration, PPI can add value relating to study methodology such as practical aspects of recruitment, the best approaches and advice on successful follow up.
• Recruitment / feasibility. Funders are very concerned with ensuring that funded projects are feasible and can be completed successfully. PPI are very helpful in ensuring that studies are likely to be acceptable to prospective participants and that issues relating to recruitment are discussed and modified as necessary.
• Patient information leaflet and consent form. While there are good guidelines and examples from ethics committees on information leaflets and patient consent forms, PPI have a vital role to play in the assessment of the appropriateness, wording and timing of research instruments (e.g. questionnaires, interview schedules) to the community, adaptation of the language of the instruments and information to suit the lay audience.

Data analysis

During analysis PPI can help ensure that emerging themes and trends were interpreted from the user perspective as well as the academic researcher perspective.

• Value of the Research to Public Health and Patient Care. This is a key requirement by funders, and again there is a lot of value from PPI comments on specific objective outcomes / benefits from the research to future patients.
• Implementation. When successful in attaining funding for a proposal it is important to have the right steering group to ensure the study proceeds as planned. There can be problems with carrying out the research, even with careful advanced preplanning and PPI involvement. It is very useful to have PPI involved in the steering group as they have a valuable role in troubleshooting and modification of research activities. This is often specified by Funders, particularly by charities.
• Dissemination. Attention to detail when writing the research findings/ results as part of the dissemination plan is very important. It is crucial to have the correct strategy at the outset. PPI can be very helpful in advising on this section during the grant-writing process. PPI are also very helpful when it comes to the actual dissemination of results, particularly to lay audiences and charitable bodies and can influence users into adoption of the research findings in the community. Barrett argues that dissemination involving PPI results in a more user-friendly outcome.
• Implementation into practice. Clinical and translational research is performed in the expectation that the results will add to the evidence base and influence clinical practice and guidelines/guidance. PPI involvement in this area could take the form of direct influence on charitable funders who can successfully promote/ implement research findings and influence change. However PPI representation is critical to the NICE process of recommending guidelines and best practice.

Challenges of involving PPI

It is important when considering PPI involvement to think about the challenges as well as opportunities that this can bring. Barret (2014) suggests the following challenges need to be thought about carefully during PPI in the research process.

• Cost and time resource implications. PPI led to increased time and cost owing to the practical aspects of planning and managing the user involvement in the research, the time and cost of building up relationships within the community and setting up user groups, the training and education for both users and researchers and the additional time needed for users to read and comment on documentation. PPI can lead to scientific and ethical conflict in protocol design, which may be due to a lack of knowledge and understanding of PPI.
• Diversity and representativeness. In data collection, PPI studies have reported the difficulty in recruiting a diverse range and representative sample of users to a project, the difficulty in balancing traditional academic criteria for reliability and user perspectives in a protocol for research.
• Confidentiality issues. It is difficult to maintain user confidentiality within meetings, where users may discuss personal experiences.
• Dynamics of the PPI group. The challenges reported by researchers in running PPI focus groups included users influencing (being more vocal over others) each other, which may result in an over-emphasizing of particular problems; groups being dominated by strong characters and their perspectives; groups being overshadowed by personal experience stories, when the aim was to identify research topics, and groups seen as a forum to get other people to accept their understanding of the disease.

PPI led to research findings being disseminated before the academic papers are published, thereby jeopardizing academic publication.

Practical suggestions

PPI is well established now as an intrinsic part of the research process. It is important to be aware of the PPI agenda and to ensure that access to PPI is available. Many charitable funders will facilitate PPI at a national level and can help with local groups. It is very important to be familiar with the appropriate funders and to maintain contact with the PPI groups. Establishment of a local PPI group will involve time and can incur expense. It is important to think about the size of any group if there is an extensive research portfolio. This is important as public representatives can easily become overloaded. Some charities and indeed INVOLVE can help provide training. INVOLVE suggest that PPI involvement is documented at each stage with clear expectations from PPI group and researchers.

• Think about who has used PPI within your local connections and researchers - link in with RDS and CLAHRC’s. Is there a local lead for PPI?
• Think about whether to cost in a chair for your steering group with expertise in PPI who can facilitate information exchange and PPI.
• Scope what your local services are for PPI involvement e.g. courses to introduce new PPI representatives to research run by the BMC, examples of research glossary.
• Create a shared data base (with the permission of PPI participants to forward your work together.

Be proactive – think about How will you involve service users/patient involvement at the beginning. It is much better to have PPI already on board and involved in the whole application process than inserting a contrived comment in response to a specific question where the lived experience of a patient or carer can be informative to the research activity. PPI is increasingly an important and integral part of research design and implementation.

For further information including external websites, see below.

Components for research proposal

• Initial proposal consideration
• Priorities (background to proposal/priority area specified in grant call?)
• Literature review/consideration
• Hypothesis generation
• Initial Protocol
• Lay statement (critical for all applications but for charitable funders in particular)
• Protocol change/iteration
• Recruitment / feasibility
• Patient information leaflet and consent form
• Value of the Research to Public Health and Patient Care
• How will you involve service users/patient involvement?
• Value of the Research to Public Health and Patient Care
• Final proposal
• Funding application
• Ethics submission
• Research Governance
• Implementation: steering group, troubleshooting, modification
• Analysis, results, outcomes
• Dissemination
• Implementation into practice.