Authors: Govind Oliver, Charlie Reynard, Blair Graham and Laura Cottey / Editors: Charlie Reynard, Govind Oliver / Codes: CC20, HAP29, SLO10 / Published: 07/04/2019
Patient and public involvement or PPI is an integral part of research in medicine. It is increasingly a mandatory requirement to have conducted PPI as part of any research proposal for the major funding bodies and not just part of good practice. We hope to explore what patient and public involvement is, why it is important that we involve patients and the public with our research, what is involved in carrying out PPI and how PPI can influence research.
PPI in research, is very simply research that is carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. 1
The term public includes: patients, potential patients, carers, health and social care service users and people from organisations representing service users. Their involvement can be as part of a project steering group offering advice, commenting on and developing research materials or direct involvement in carrying out the research and interviewing research participants.
PPI is directly shaping the future of emergency care research. For instance, the Royal College of Emergency Medicine (RCEM) collaborated with the James Lind Alliance (JLA) to carry out a research priority setting partnership. In this large piece of PPI work they engaged clinicians, patients, carers and the public to prioritise research questions 2. When it comes to using PPI to inform individual studies, many NHS organisations and universities have their own PPI groups. Access to a meeting can often be organised by contacting the relevant Research and Development department. One notable example of a relevant PPI group is the Sheffield Emergency Care Forum whose volunteer members meet periodically and directly inform Emergency Care research. Indeed, we would implore anyone interested in furthering their knowledge of PPI within emergency care to read the excellent article published by the group’s lay chair in the EMJ.2
It is fundamentally important that we recognise and draw distinction between the perspectives of the public and the perspectives of people who have a professional role in health and social care services.1
The perspectives of both groups often run parallel, but sometimes unexpectedly diverge; these need to be understood as part knowing that our study embodies the guiding principles of research. A fundamental principle is autonomy. As paragraph eight of the Helsinki Declaration states the goal of research “can never take precedence over the rights and interest of individual research subjects.”4 A second principle is beneficence. Research should have the welfare of the research participant, as the goal of the trial.4 Paired with beneficence is non-maleficence; every effort should be made to avoid harm to the patient. Differences between public and professionals could alter the paradigm as to whether aspects of the research are consistent with these principles. Due to the aforementioned points, PPI is now seen as an absolute necessity in almost all research by those conducting, funding it and in ethical/editorial review. The dialogue process through conducting PPI can also significantly enhance our research. The alternative viewpoints that the public bring can spot holes and enhance our protocols, offer pragmatic solutions to dilemmas and help guide the content of what information and follow up is implemented within our protocols. This continues through the live studies, with lay representatives on trial steering and management committees offering different perspectives to enhance the study. Recently this has seen the move to having lay summaries in publications but also lay members authoring them. In short their influence can be invaluable.
We are very excited about The Trainee Inter-shift Recovery in the ED (TIRED) going live in May. To find out more about this TERN project you can read the informative piece on RCEMLearning by Laura Cottey and Blair Graham:
As part of the process of transitioning from research idea to a research reality, several key pieces of PPI have been conducted, which had a dramatic effect on their research proposal. They presented the key aims of the TIRED study to over 100 members of the public at a Research and Development PPI conference. This highlighted the high priority placed by the public on ensuring clinician well-being in order to ensure patient safety. TERN trainee representatives also helped them with critical feedback on how to make the methodology and survey as acceptable and friendly as possible to the end-user which will be the trainee completing the survey.
One of the key points we hope to highlight is how PPI can drive changes in a study protocol. This is exemplified by one of their final PPI activities where a wide range of stakeholders attended an exercise at the EMTA conference in Cardiff. This group consisted of trainees at all levels and consultants, including some experts in workforce planning. The focus groups informed significant amendments in the study design:
- The length of the survey was decreased
- A very important perspective on the need to differentiate Need For Recovery (NFR) from occupational burnout was highlighted. As a result, the decision was made to exclude occupational burnout and burnout inventory questions in the final TIRED study questionnaire based on this feedback.
- The utility of repeat survey was also questioned. Due to multiple confounding factors such as job rotations their feedback was that a repeat survey would not be helpful or pragmatic. As a result, the TIRED study will provide a single discrete measurement of NFR across ED doctors in the UK, which may drive further research ideas.
We are really looking forward to our TERN project going live and will of course be sharing our results in due course.
- Avoid viewing PPI as just another ‘tick box’ exercise. Not least, this is unfair to those who donate their time to help assist the process. Done well, PPI can genuinely increase the acceptability, operational feasibility and impact of research.
- PPI is not just about research design but can be used to inform every step of the process, right through to the dissemination of findings.
- Pitching a research idea at a large public forum is a great litmus test of a concept. The audience has selected to attend, so expect a high level of engagement. It is important to present in a format that all those present will understand, whilst being careful not to ‘dumb down’ too much. Some may bring a personal ‘agenda’ to the meeting, which can provide additional challenge, particularly when it comes to managing questions!
- Stick around to chat with PPI group members during breaks and after the meeting. Additional individual perspectives may emerge and provide insights, and links may be made for the future.
- Be aware that pre-formed PPI groups may not be fully representative of the target population: particularly if looking at a very select or under-represented group, it may be necessary to purposefully seek out participants. Patient groups and charities may be able to help.
- Aim to engage a wide range of stakeholders in PPI. Consider carers, relatives, health professionals, and involving other parties such as specific advocacy groups and third sector organisations.
- If hosting a PPI event or meeting, ensure there is adequate parking (including disabled spaces) and that the venue is fully accessible and provide refreshments. Ideally expenses should be paid in line with guidance.
- Always gain appropriate consent if recording meetings, and stipulate that participants have right to withdraw at any time.
Evaluate the findings of the PPI exercise carefully – it may not be necessary (or desirable) to action every proposed amendment.
The INVOLVE website (the part of the National Institute of Health Research (NIHR) dedicated to PPI), has a wealth of further information and responses to other frequently asked questions about PPI.
- NIHR Involve
- Smith J, Keating L, Flowerdew L, et al. An Emergency Medicine Research Priority Setting Partnership to establish the top 10 research priorities in emergency medicine. Emerg Med J 2017;34:454-6.
- Hirst E, Irving A, Goodacre S. Patient and public involvement in emergency care research. EMJ 33; 9
- World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects