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What is public and patient involvement?
Public and patient involvement (PPI) in health research is a dynamic partnership between patients and/or members of the public and researchers. Involvement is distinct from being subjects of research (participation) as patients contribute to the research process as advisors and sometimes co-researchers. In practice, this may mean involvement in prioritising and developing research ideas, contributing to study design, carrying out the research and research dissemination.1 It should be emphasised that involvement is carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them.2
Why is PPI needed?
PPI offers researchers valuable and unique insight into the particular condition being investigated to make research more relevant to patients. PPI is needed to improve the quality of research and increase accountability. It is also reported to have benefits of increased recruitment and retention of study participants.3 The reasons for this are varied. The research questions are more likely to be aligned with outcomes valued by patients. Recruitment materials designed with the public will be written more suitably and with greater relevance. Importantly, the public bring important insight into how burdensome study requirements are to everyday life. Additionally, the idea of PPI is itself appealing, which increases willingness to participate in research.
For today's researchers, active PPI has further relevance as funding bodies frequently require evidence of PPI in the development of a research proposal and ask how patients and the public might be involved in the conduct of the research. For patients, it is ethical for them to have a voice in research that may have an impact on their health.
Dame Sally Davies, chief medical officer for England, advocates PPI as the rule rather than the exception:No matter how complicated the research, or how brilliant the researcher, patients and the public always offer unique, invaluable insights. Their advice when designing, implementing and evaluating research invariably makes studies more effective, more credible and often more cost effective2
Current state of PPI in paediatric research in the UK
PPI is a developing field in paediatric research. It is recognised that children and adolescents (referred to collectively as young people) are not ‘small adults’. Methods for PPI in adult research are not necessarily appropriate for young people. The involvement of young people, their parents and carers needs to be tailored to their specific developmental and lifestyle needs. This may be through social media engagement, for example, and timing of PPI consultations during weekends and school holidays. Involving older children and adolescents in research design may improve adherence with study requirements and ensure the research is relevant to them.4
A report by the UK Nuffield Council on Bioethics calls for researchers to be trustworthy, open and courageous when designing and conducting clinical research involving young people and urges them to involve young people and their parents in the design of research from the beginning.5
How to get the most out of PPI?
The authors have highlighted a number of considerations for researchers embarking on PPI in paediatrics with quotes from families who have been involved in paediatric research (box 1).
Ten tips on how to involve young people (and families) in research
Involve young people and families early Ideally plan how young people (and families) will be involved before you start a project. This can be from advising on research priorities, to developing the proposal, helping with recruitment through to disseminating findings.
Pinpoint the role for the young people and families Think about both what the benefits will be for the young person and family and how this will influence the research. Ask young people for their views on this. If you are clear about the impact of involvement, you can then assess if this has been achieved when the project finishes.
Make it totally explicit what you are trying to achieve and have that clearly stated on all materials. For example, ‘Study on how to reduce deaths from febrile neutropenia’.
Think about who you want to involve Are you looking for specific ages or health conditions as this will influence how you recruit young people (and families). There are different options: form your own young person's group—this could be face-to-face meetings or consultation online or tap into existing groups or networks (see box 2).
If the research is ongoing you need to consider whether you want parents of both children on treatment and off treatment involved? You get different views once there is a degree of distance/time after treatment or bereavement.
It is important to consider the very different approaches required for a 5-year-old and a 15-year-old, for example. Also, the fluctuating level of illness of a young person also needs to be taken into account.
Get consent If forming your own group, make sure you get consent from the young people and from parents or carers of anyone under 16. Speak with the parents before speaking to young children about seeking consent/assent.
Check with the parents how much the child knows about the disease and outcome before mentioning these things to the child.
Individual parent and child consultation views within the same family might be very different
You want to try to avoid the situation where a young child doesn't want to be part of the research but the parents do and feel it is in the child's best interests to join. In this case consent/assent should not be sought from young children.
Train and support your young people and families This will help them take a meaningful role. For example, it is helpful for the young people and families to have some understanding of research!
If you are holding a meeting give any materials (including a ‘lay’ summary, if relevant) or slides before the meeting. This allows people to follow along, contribute and just write down things they don't understand and ask questions later. Don't use acronyms and keep medical terms to a minimum.
Reward the young people for their involvement Travel expenses, for example, should be paid for. It is important to recognise the young person's contributions—this could be in the form of high street shopping vouchers and/or certificates or records demonstrating what they have done and the skills they have developed.
Be honest about what you can offer and what you can't: what is in your power to change and what isn't. If this isn't clear you might get parents upset about other issues such as parking charges/other bugbears etc.
Ensure safeguarding procedures are in place Make sure the research and young people's involvement is ethical and ensure the young people's health, safety and well-being.
Remember logistics Young people attend school, and parents have childcare responsibilities. If you plan to involve young people, it will need to be in school holidays, at weekends or in the evenings.
If you are holding meetings, think about providing childcare. Also, it is good practice to cover the travel expenses for young people and parents and to hold the meetings/interviews when they will be at hospital.
Try different methods of keeping in touch with young people Ask the young people what is their preferred way to be contacted—some prefer email, others social networking sites or by text.
Ensure the young people and families are given feedback Knowing what difference their involvement has made is likely to improve motivation to remain involved in research.
When someone comments or participates please acknowledge you have received their email as it is frustrating to have to send follow-up emails to check this.
Be honest about not knowing the answers to everything. This is important and honesty will be appreciated.
Case study of PPI in action: PEPtalk2
PEPtalk 2 is a randomised pilot study, funded by National Institute for Health Research (NIHR), which investigated whether varicella zoster immunoglobulin (VZIG) injection was as least as good as a course of oral aciclovir as postexposure prophylaxis for chickenpox in children with cancer.
Parents of children with cancer were actively involved in all stages of the research process. An initial online survey was conducted to obtain qualitative data from parents on chickenpox prevention in children with cancer. The survey provided an opportunity for families to reflect on the experience of receiving prophylaxis following a chickenpox exposure. Following this survey, the study was designed with a lay reference group of parents recruited from national children's cancer networks. One parent (NR) became a co-applicant on the grant application to NIHR. The lay reference group provided valuable feedback on the feasibility of the research proposal and were further consulted on project documentation including participant information sheets and consent forms. The parents were able to advise on study visit frequency, parent survey design and the research protocol itself. The group will be involved in analysis and interpretation of the results and plan to write a lay summary of results for dissemination.
Further resources can be found from existing groups, who already promote PPI in paediatric settings (box 2).
Resources for PPI in paediatric settings
GenerationR
Young Person's Advisory Group (initiated by National Institute for Health Research (NIHR) Medicines for Children Research Network in 2006) was set-up to provide a forum where young people across the UK could support the design and delivery of paediatric research. Each local group comprises of approximately 10–15 members who are aged between 8 and 19 years old who offer advice to researchers on whether their proposed studies and information materials are acceptable to children (http://www.generationr.org).
NIHR: clinical studies groups
Within the NIHR Clinical Research Network: Children's Speciality, these groups, which cover 14 subspecialty areas, are made-up of active researchers, parents, doctors, nurses, charity representatives and formulation experts with an aim to promote high-quality healthcare research.6
INVOLVE
NIHR fund this national advisory group. It brings together expertise, insight and experience in the field of public involvement in research. One of their projects has been to set-up an area on their website with information and resources on involving young people in research (http://www.invo.org.uk).7
National Children's Bureau: young research advisors
The National Children's Bureau supports a group of research trained young people aged 12–21, who consult and collaborate on research projects. This group has published useful guidance on how to involve young people in research.8
Conclusion
The last 15 years has seen increasing involvement of patients in research with recognition that those affected by research have a right to help direct what and how research is undertaken. Parents and young people can offer unique experiential expertise to identify relevant research priorities, enhance study design and increase recruitment. Young people involved in research summarise the importance of PPI “…involving us in planning research helps make sure researchers are asking the right questions in the right way”.8
Footnotes
Correction notice This paper has been amended since it was published Online First. The affiliations have been corrected.
Twitter Follow Jessica Bate at @jessica_bate
Contributors JB conceived the idea and led on writing of the manuscript. Contributions were received from NR, RL, JP, RN and SD, and all authors edited the final manuscript.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.