Patient and Public Involvement in Health Research: Standards, Methods and Reporting
In health research, the voices of patients, carers and the public are now formally built into how many studies are funded, designed and reported. In the UK this is called patient and public involvement, or PPI; in the United States, "patient engagement" is the more common term. This article explains what involvement means, the standards that guide it and how to report it.
Involvement, participation and engagement
UK guidance distinguishes three activities that are often confused:
- Involvement: members of the public actively work with researchers to plan, conduct and share research, for example by helping to choose the question, reviewing documents, sitting on steering committees or co-analysing data.
- Participation: people take part in a study as participants, for example by joining a trial or answering a questionnaire.
- Engagement: information and knowledge about research are shared with the public, for example through open days, festivals or media.
The National Institute for Health and Care Research (NIHR) uses the definition developed by INVOLVE, its former advisory body: public involvement is research being carried out "with" or "by" members of the public rather than "to", "about" or "for" them. INVOLVE grew out of a Department of Health advisory group on consumer involvement set up in 1996, later renamed Consumers in NHS Research and then INVOLVE.
The UK Standards for Public Involvement
The UK Standards for Public Involvement were developed by a UK-wide partnership of health research organisations and published in November 2019. They are hosted with supporting resources on the Learning for Involvement website. The six standards are:
- Inclusive opportunities: offer public involvement opportunities that are accessible and that reach people and groups according to research needs.
- Working together: work together in a way that values all contributions and builds and sustains mutually respectful and productive relationships.
- Support and learning: offer and promote support and learning opportunities that build confidence and skills for public involvement in research.
- Governance: involve the public in research management, regulation, leadership and decision-making.
- Communications: use plain language for well-timed and relevant communications, as part of involvement plans and activities.
- Impact: seek improvement by identifying and sharing the difference that public involvement makes to research.
Most NIHR funding applications must describe how the public has been and will be involved, and applicants are expected to budget for involvement costs, including payment for people's time.
Setting priorities: the James Lind Alliance
Involvement can start before any study is designed, by asking which questions matter most. The James Lind Alliance, established in 2004 and now coordinated by the NIHR, runs Priority Setting Partnerships in which patients, carers and clinicians identify and rank unanswered questions about the treatment of a condition, usually producing a "top 10". The method has been used for conditions ranging from asthma to dementia, and funders use the resulting lists to commission research.
Patient engagement in the United States
In the United States, the Patient-Centered Outcomes Research Institute (PCORI), established under the Patient Protection and Affordable Care Act of 2010, requires the research it funds to engage patients and other stakeholders and evaluates applications partly on engagement. PCORI publishes an engagement rubric and funds engagement awards to build capacity. Other federal funders, including the National Institutes of Health, support community engagement through specific programmes, for example community engagement cores in clinical and translational science centres.
Reporting involvement: GRIPP2
For a long time, published papers rarely said whether patients had been involved, or what difference it made. The GRIPP2 checklist (Guidance for Reporting Involvement of Patients and the Public, version 2), published by Sophie Staniszewska and colleagues in The BMJ in 2017, offers a long form for studies focused on involvement and a short form for other studies. The short form asks authors to report the aim of involvement, the methods used, the results and outcomes, and a critical reflection. Several journals, including The BMJ, ask authors to include a statement on patient and public involvement.
How to involve people well
- Start early. Involve people when the research question is still open, ideally before applying for funding.
- Be clear about roles. Explain what people are being asked to do, how much time it takes and what influence they will have.
- Reach beyond the usual voices. Panels often over-represent people who are older, white and well educated. Work with community organisations to reach others, and go to people rather than expecting them to come to the university.
- Pay and support people. Cover expenses, offer payment for time, and provide training and a named contact.
- Close the loop. Tell contributors what changed as a result of their input, and what did not and why.
Involvement in health research shares much with co-production, which goes further by sharing power throughout a project. Measuring what involvement achieves is discussed in our article on evaluating participatory research. Outside health, science shops offer another route for community questions to reach universities.
Sources
- NIHR, Briefing notes for researchers: public involvement in NHS, health and social care research.
- UK Public Involvement Standards Development Partnership, UK Standards for Public Involvement, 2019.
- James Lind Alliance, The James Lind Alliance Guidebook.
- Sophie Staniszewska et al., "GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research", BMJ, vol. 358, 2017, j3453.
- Patient-Centered Outcomes Research Institute, Engagement Rubric.
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