Involving older people in the design and conduct of clinical trials:

Kate Wilde and Zena Jones

Key points

There are strong policy drivers in the UK to involve patients not only as participants in research, but also as members of the research team.

Patient and public involvement (PPI) can have significant benefits to the patient as well as to the research project.

Many research funders require PPI explicitly described and evaluated in research proposals.

Researchers need increased awareness of PPI, guidance, and a framework of how best to implement PPI within their research strategies.

There is a risk of ‘tokenistic’ involvement of service users.

There is the potential for a power struggle between the PPI representative with personal experience and the lead researcher with academic knowledge of the condition studied.

There is a need to formally evaluate the impact of PPI on the effectiveness of research to bring new treatments to patients.

1 Introduction

The views of customers or service users, expressed by ‘voting with their feet’ (or wallets), clearly have an impact on the success of a business. However, where there is a monopoly, this mechanism of quality control is considerably weakened. The introduction of a national health service created such a monopoly and therefore risks losing contact with service users. The notion that patients could be regarded as consumers was promoted by the publication of the consultative paper ‘Patients First’ in 1979 (1). An attempt to rename patients as consumers has been unsuccessful in the health service, although social services introduced and kept the consumer-oriented term ‘client’ (2,3). The idea of active involvement of service users in the development and running of health services was introduced by the publication of ‘Patient and Public Involvement in the New NHS’ in 1999 (4). The benefits the Department of Health anticipated from involving patients are highlighted in this paper and summarized in Box 15.1. ‘Patient experience’ has since become an important driver in service development, design of governance standards, national service frameworks, and policy documents such as the ‘Standards for Better Health’ (2006) (5).

Box 15.1 Potential benefits of patient and public involvement in the health service

The patient perspective: Patients are the experts in how they feel and what it is like to live with a condition.

Improving services: By involving users and carers during planning and development, there is less risk of providing inappropriate services and more chance of services being provided in the way people want them.

Improving public understanding: Greater openness, accountability, and involvement of the public should help to create a better understanding of complex NHS and health issues and strengthen public confidence in the NHS.

Improving health: Involving people in influential decisions can improve their self-esteem, confidence, and overall well-being.

Text extract reproduced from NHS Executive. Patient and public involvement in the new NHS. Leeds: Department of Health; 1999.

<http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4004176> (4) under the Open Government Licence v2.0.

Since then this concept has become pervasive throughout the NHS, generating further publications and guidance (Box 15.2).

Box 15.2 Key publications relating to patient and public involvement in the health service

Section 11 of the Health and Social Care Act (2001) indicates a statutory duty to consult and involve patients and the public (6).

Patient and public involvement in health: The evidence for policy implementation (2004) (7).

Our health, our care, our say: a new direction for community services (2006) (8).

A stronger local voice: A framework for creating a stronger local voice in the development of health and social care services (2006) (9). These plans included the establishment of Local Involvement Networks (LINks) which replaced patient forums.

An economic case for patient and public involvement (2012) (10).

A consequence of the perceived success of patient involvement in the development and delivery of NHS is that policymakers question their attitude to patients in other aspects of the provision of health care. It is believed that active involvement of the public in the research process leads to more relevant, applicable research outcomes that result in improvements in practice in health and social care. When the Department of Health and the National Institute of Health Research set up the clinical research networks, involvement of service users, not only as subjects of research but as active members of the research team, became an integral part of the constitution of these organisations. Funders of research also recognized the importance of the patients’ voice and required service-user input into research protocols, trial steering and management committees, and research dissemination (11,12). Some links to current guidance and views can be seen in the document and website sections at the end of the chapter. The ‘Research Governance Framework for Health and Social Care’ (13) requires the active involvement of service users and carers at every stage of research and promotes a move towards greater openness about research undertaken by organizations.

2 Defining and promoting patient and public involvement

Patient and public involvement (PPI) requires the active participation of service users in the development and management of the research project, rather than the participation as a subject of the research. While some patients may engage in research in several roles—subject and advisor, for example—only the advisory element is regarded as PPI. PPI can occur at several levels; these are:

1 Consultation—Patients and public are asked to comment on the design, the wording, and overall look and feel of research proposals, documents, and policy material. While much input may be sought, the role is mainly editorial: the critique of materials that have already been written on a topic that has been decided upon by professionals.

2 Collaboration—Patients and the public are involved in the design, strategic decisions, and the generation of a concept, and are partners and co-members of the research team.

3 Patient- and public-led research—Patients and members of the public generate and develop the research idea. They are the lead researchers and the rest of the research team support them to design a protocol and funding proposal, recruit patients, analyze data, etc.

Presently most PPI involves a combination of collaboration and consultation; although patient-led research is seen as the pinnacle of PPI, this remains relatively rare (14).

The organization INVOLVE was set up through a Department of Health initiative to ensure active public involvement in research and development in the NHS. Their remit is to:

promote the empowerment of the public to become more involved in research

develop alliances between the public, researchers, the Department of Health, and other research funders and sponsors in order to promote greater public involvement in research

monitor public involvement in research

encourage the evaluation of the effects of public involvement in research.

INVOLVE reports to the Department of Health on progress, and makes recommendations about the development of public involvement in research. Their policies are outlined on their website (<www.invo.org.uk>), which also provides guidance documents and evidence for the effectiveness of PPI.

There is therefore no doubt that the relevance of patient and public involvement in research is accepted by policymakers in the UK, but while the underlying rationale is convincing, it will be important to examine whether this has had any impact on the quality of research and the implementation of results. Scepticism exists among health care professionals, researchers, and members of the public.

3 Role of older people in patient and public involvement in research

There is a growing body of publications examining PPI in research relating to older people (15–25). In addition, the National Institute for Health Research clinical research networks collect case stories to illustrate benefits and issues (Boxes 15.3–15.5). The following themes emerge from this literature:

Involving older people in research benefits researchers.

This ensures the outcomes of the research are more applicable to the health care setting and patient group.

Older people may provide greater insight and qualitative data on issues.

Their involvement can benefit the quality of the research data.

Older people themselves benefit from being involved.

Provision of training and support to older people is essential.

Involvement of older people helps to challenge stereotypes and ageism, and promotes a positive image for older people.

Researchers need to be aware of and guard against tokenism.

PPI takes time and this needs to be planned for in a project.

These themes are explored further in the following sections.

4 What are the benefits of PPI?

This section discusses the benefits of PPI in relation to older people along with the potential and actual benefits to the research team, the quality of the research, and implementation of results into clinical practice.

4.1 Benefits to older people who get involved

Analysis of the evidence outlined in section 2 of this chapter suggests that PPI has a number of benefits for older people involved in research. These include the chance to meet new people, visit new places, and redevelop social skills. The case study in Box 15.3 endorses this observation, noting particularly how much the patient’s dysphasia improved after getting involved.

Box 15.3 My research journey

In this video a stroke survivor describes how getting involved in research has assisted with his rehabilitation and has opened up new opportunities for him, socially and intellectually. Video link: <http://www.youtube.com/watch?v=fWNNhieJ00g>

Davis and Nolan (15) noted that the older people made new friends during their research involvement, built confidence, developed new skills, and had greater visibility. Loss of confidence and role in society can lead to older people feeling they are becoming invisible. This was highlighted by the case study of a 65-year-old woman who reported, ‘When you get older you suddenly become invisible. You can walk into a shop and people just don’t see you or hear you. I never thought it would be like that, never thought I would disappear.’

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