xxUnit I OLDxx

1. Course introduction

This course will introduce the student to the principles and practice of involving patients and the public in research. Patient and public involvement is when members of the public are actively involved in research studies, working with researchers on the development, conduct, dissemination and governance of clinical research. Patient and public involvement does not mean recruiting patients as participants in research studies.

Patient and public involvement is firmly established in health research policy in the United Kingdom and many (but not all) countries internationally. Including patient and public perspectives in the research team, it is claimed, improves the quality of research and ensures research is relevant to people who use health services. Public engagement is a related area, which incorporates communicating with the public about research: what researchers do, why they do it, what it contributes to society. Effective involvement and engagement of patients and members of the public in research requires researchers to reflect on their own values and practice, including their views of ‘expertise’. This course will enable participants to analyse and debate the value of patient and public involvement in research and develop their skills in implementing it in their own practice.

Patient and public involvement in research is a developing field. The course may challenge some of your understandings of what constitutes an expert, how you interact with patients and your ways of working. Keeping a reflective diary which incorporates your learning and perceptions is essential and will be of great assistance to you in completing the assignments for this course.

1.1. Learning outcomes

After completion of this module, the candidate should be able to:

• Critically appraise the theory and key principles of patient and public involvement in clinical research
• Examine the barriers to effective patient involvement and strategies and techniques to overcome such barriers
• Design a patient and public involvement strategy for a clinical trial
• Demonstrate the skills to explain the role of patient involvement in a clinical trial to a lay person

• Critically assess their own practice/place of work in relation to the level of patient and public involvement in research

1.2. Core Readings

INVOLVE is a UK government funded programme which supports patient and public in health research. The INVOLVE website will give you a comprehensive introduction to the field; you will find definitions, guides to involvement, discussions of evidence/impact and much more http://www.invo.org.uk/

This INVOLVE report will give you an insight into a range of ways patients can get involved and researchers’ views of the benefits:

INVOLVE (2014) NIHR Senior Investigators: leaders for patient and public involvement in research. INVOLVE, Eastleigh. http://www.invo.org.uk/wp-content/uploads/2014/07/NIHRSeniorInvestigatorsINVOLVE2014.pdf

Throughout the course, please keep an eye on these patient involvement blogs:

• Derek Stewart’s Make a Difference blog http://derek-online.blogspot.co.uk/
• Simon Denegri’s lay review http://simondenegri.com/

1.3. Unit introduction

This unit will introduce the student to the principles and practice of involving patients and the public in research.  We will start with definitions of patient and public involvement in research and examine the principles which guide its practice. We will explore the social, theoretical and policy drivers which have led to its adoption and consider what benefits are claimed to arise from involving patients and members of the public in research.

2. Lesson 1: Guest lecture

Patient and Public Involvement in Research: key concepts and definitions

Reading

As in the core readings section. Please look at our own Wellcome Trust Clinical Research Facility web pages on patient and public involvement before the lecture:  https://www.crts.org.uk/

2.1. Profile: Dr Allison Worth

Dr Allison Worth

3. Involvement

What is patient and public involvement in research?

INVOLVE defines it as “research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them”.  It might include: involving people in determining research priorities for a particular condition; being co-applicants on a research grant; advising on study materials; contributing to data collection, analysis or reports.

What is the difference between a ‘patient’ and a ‘member of the public’?

Usually, if you want to involve someone with a particular health condition, they will be referred to as a patient, but members of the public can provide a generic lay perspective on research. Family members of people with a particular illness or parents may also have valuable perspectives.

What is public engagement?

Public engagement is about communicating what we do to the public. This might include our research findings, the value of what we do, engaging people with science. It is related to, and overlaps with, patient and public involvement – people who understand the benefits of research are more likely to want to be involved. We will return to the topic of public engagement in week 5 in more detail.

Illustrative examples of these topics will be discussed.

3.1. Your turn: stop & think

Stop & think Question 1: What is the difference in perspective between a ‘patient’ and a ‘member of the public’ and what they might bring to research? show answer hide answer Answer 1 [This is placeholder text for answer 1] Question 2: Can you explain the relationship between patient involvement and public engagement? show answer hide answer Answer 2 [This is placeholder text for answer 2]

3.2. Benefits

What are the proposed benefits of involving people in research?

It is claimed that patient and public involvement improves the quality, relevance and impact of research. These are some of the proposed benefits:

• It ensures research is relevant to the needs of patients and society
• It improves study design
• It improves recruitment and retention
• It improves communication between researchers and participants and between researchers and the public

Assumptions and misconceptions. 

There are some tensions in the patient and public involvement field. 

Assumptions:

• Patients and the public bring a different kind of expertise to a research team
• The patient/lay viewpoint will be welcomed by researchers
• Patients want to become involved in this way
• PPI is a moral imperative
• Patients/the public assume that research leads to better health care (of course, we hope it does, but it may not be as rapid as they expect)

Misconceptions:

• Recruiting patients or interviewing patients as part of a study is involving them

Healthcare researchers have all the necessary expertise for a clinical trial without involving patients.

3.3. Your turn: reflection activity

Reflection [new activity type-needs a new icon]: What is your initial reaction to the concept of patient and public involvement in research? Reflect on the situation in your own workplace – how far is your workplace engaged and what more could be done?

3.4. Your turn: thought discussion 1

Let’s talk about lay and professional expertise. Healthcare researchers sometimes tell me that, because of their clinical activities, they can represent patient views and understand their needs, so they don’t need to involve them in their research. In my view, that is a misconception – would anyone like to challenge me on that?

4. Lesson 2

Underpinning principles and values

Partner Reading

Ives J, Damery S, Redwod S. PPI, paradoxes and Plato: who’s sailing the ship? J Med Ethics 2013;39:181–185. doi:10.1136/medethics-2011-100150

Topics

• Origins of patient and public involvement in research
• Underpinning principles of patient and public involvement in research
• Levels of involvement

4.1. PPI: History and values

Origins of patient and public involvement in research

Still trying to find a good history….1970’s consumerism in health care/society; participatory research; citizen science

Underpinning values

Ives et al. identify two categories of motivation for patient and public involvement in research:

1. Pragmatic/outcome oriented – PPI is a means to an end i.e. it improves the relevance and quality of research
2. Ideological/process oriented – PPI is an end in itself i.e. it reflects democratic and ethical principles

There’s a third motivation which is not value-driven:  researchers involve patients and the public because they are required to, usually by the grant-funding body they are applying to.

Let’s examine these in more detail.

1. The pragmatic argument: patients’ experiential knowledge of illness and health care will be beneficial to research, therefore it is useful
2. The moral imperative: patients/the public have a right to be involved in publicly funded research that may impact on their health and services; it improves the transparency and accountability of research
3. Ticking the PPI box to get a grant, without necessarily believing in it

Levels of involvement

The involvement – collaboration continuum; Arnstein’s ladder; partnership and reciprocity

4.2. Your turn: motivations

Stop & think How might the three different motivations for involving people influence how patient and public involvement is conducted? show answer hide answer Answer [placeholder - no answer at present]

4.3. Your turn: thought discussion 2

Critically appraise these assertions by Ives et al:

1. A fully democratic, cooperative model of PPI is an ideal that can never truly flourish, because the concept is not internally coherent;

Once a patient or member of the public undergoes training, and becomes familiar enough with research to be substantially involved, their ‘lay’ status is compromised

5. Lesson 3

Partner Reading

Browse the INVOLVE Putting it into Practice database at http://www.invo.org.uk/resource-centre/putting-it-into-practice-database/

Here is an example of a local study involving patients in a trial: Fairbrother P, McCloughan L, Adam G, et al. Involving patients in clinical research: the Telescot Patient Panel. Health Expectations 2013; doi: 10.1111/hex.12132.

Topics

• Ways of involving patients and the public in research
• How to find the ’right’ people – including the thorny issue of representativeness

Meaningful v tokenistic involvement

5.1. Your turn: stop & think

Stop & think Question 1: [Question 1] show answer hide answer Answer 1 [This is placeholder text for answer 1] Question 2: [Question 2] show answer hide answer Answer 2 [This is placeholder text for answer 2]

5.2. Your turn: reflection activity

Reflection: Now you know more, what is your personal and professional view on whether patient and public involvement in a clinical trials setting is: a good idea in principle b) practical and achievable in practice?

To what extent do you think the values underpinning patient and public involvement in research are realised in effective practice?

5.3. Unit I summary

You now have an understanding of the nature of patient and public involvement in research from policy, theoretical and clinical/managerial perspectives. Hopefully, you have reflected on your own stance regarding the purpose and value of PPI. This means you have the baseline knowledge to tackle Unit II where we will consider in greater detail the barriers and facilitators to making patient and public involvement work in practice.