Original papers Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

The authors R. Telford is an Honorary Research Fellow and a Consultant Clinical Psychologist, Community Health Sheffield NHS Trust, University of Sheffield, School of Health and Related Research, Sheffield, UK. C.A. Beverley is a Systematic Reviews Information Officer and C.L. Cooper is a Senior Research Fellow, both at University of Sheffield, School of Health and Related Research, Sheffield, UK. J.D. Boote is an Honorary Research Fellow at the University of Sheffield, School of Health and Related Research and Senior Research Assistant, Community Health Sheffield, NHS Trust, Sheffield, UK. Keywords Health care, National Health Service, R&D, User studies Abstract Consumer involvement is now firmly established as National Health Service (NHS) R&D policy. This study identified the range and diversity of current NHS research projects involving consumers within an NHS region, to investigate the extent to which the policy is being implemented. Trust R&D directors and managers were surveyed and the National Research Register scrutinized. Researchers were found to be involving consumers in research in less than a third of trusts in the region. Difficulties were encountered in categorising research activities and the level of consumer involvement, suggesting that more precision in describing consumer involvement in the research process is necessary. Researchers had concerns about the practicalities of involving consumers and expressed a need for more direction and resources. Makes recommendations for trust management to facilitate more active involvement of consumers in research. Electronic access The current issue and full text archive of this journal is available at http://www.emeraldinsight.com/1466-4100.htm
British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . pp. 92103 # MCB UP Limited . ISSN 1466-4100 DOI 10.1108/14664100210427606

Introduction
There is now clear guidance and expectation from the Department of Health for NHS researchers to involve consumers in the research process (Department of Health, 1999a; Standing Advisory Group on Consumer Involvement in the NHS R&D Programme, 1998). Advice and information has been prepared for both consumers (Consumers in NHS Research, 1999) and researchers (Hanley et al., 2000), and assistance is available from the Consumers in NHS Support Unit (Hanley et al., 2000) to implement the policy. Involving consumers in research is said to lead to research of a higher quality and greater clinical relevance to the NHS (Hanley et al., 2000). The Department of Health has shown its commitment to the initiative by requiring trusts holding NHS R&D Support Funding to demonstrate evidence of involving consumers in their research activity (Department of Health, 1999b). Furthermore, the recent Research Governance Framework for Health and Social Care (Department of Health, 2001) stipulates that consumers should be involved at various stages of the development and execution of research projects where appropriate, and should also be informed about research being undertaken.

Reasons for including consumers in research

Three main reasons have been put forward for involving consumers in research: (1) it is a political imperative; (2) it is morally correct; and (3) involving consumers benefits the research process. Political imperative Current policy directives have been briefly mentioned above. The impetus to involve consumers in research follows earlier advances in consumer involvement in health care services (Lindow and Morris, 1995) and audit (Kelson, 1996). These developments have taken place in the context of academic research into illness and health behaviour, which has led to an increasing recognition of the role of consumers in managing their own health, and the significance of cultural and social values in the development and appraisal 92

Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

of research knowledge (Entwistle et al., 1998; Allsop, 1996). There is now growing acceptance of the inclusion of consumers as experts in many aspects of health and social care (Department of Health, 1999a). Moral issues As citizens and ``owners'' of the NHS it is suggested that consumers are entitled to have a voice about research issues in their health service (Entwistle et al., 1998). Consumers' rights and responsibilities have been developed by international forums (Bastian, 1998), and include the right: to safety; to be informed; to choose; to redress; to be heard; to consumer education; to a healthy environment; and to satisfaction of basic needs. International consumer organisations have added the following responsibilities: critical awareness, action, social responsibility, ecological responsibility, and solidarity. Benefits to the research process The disease model is not appropriate for all health issues, and the model of ``passive consumer and active doctor'' has evolved into a more interactionist paradigm, with a reconceptualisation of roles (Allsop, 1996). Consumers manage their health and illness in complex ways, and by bringing their unique perspectives on health issues to the research agenda, are able to complement the medical perspective (Faulkner and Layzell, 2000; Goodare and Lockwood, 1999; Ong, 1996). Consumers can highlight important issues of which researchers may be unaware, thus widening the scope of health research which has been criticised as being narrow, reflecting individual researchers' preferences (Barnes, 1985). Chalmers (1995) cited examples of a consumer proposing a link between vaginal adenocarcinoma and diethylstilboestrol, and another suggesting that a low maternal serum alpha fetoprotein concentration might be a marker for trisomy. Mismatches between the views and priorities of consumers and researchers in relation to health issues have been identified, confirming that professionals cannot necessarily speak for consumers (Allsop, 1996; Grant-Pearce et al., 1998). The potential benefits of consumers prioritising the research agenda were shown when a systematic review of available treatments for osteoarthritis of the knee revealed a wider 93

range of treatment options being used by patients than was evident in the literature (Tallon et al., 2000): while many people had tried physiotherapy, educational interventions or complementary therapies, relatively few studies had investigated these approaches. Traditionally, health care research has focused on knowledge for understanding, while consumers are more interested in knowledge for action (Cornwall and Jewkes, 1995; Nicolson et al., 2001). Including consumers in research can therefore focus efforts to disseminate and implement research findings, thus widening the influence of consumers. There is accumulating evidence of the importance of emotional, social and cultural issues to consumers (Oliver, 1997; Allsop, 1996), and it is likely that this research agenda would be marginalised without their support. Noting that health outcomes may be valued differently by researchers and consumers, Oliver (1995) described how consumers can:
. . . bridge the gap between the public and researchers by explaining research issues to a wide audience, presenting the needs and views of health service users to the research community, and suggesting how members of the public may be approached for their views directly.

Reaching out to groups who might be disregarded as research partners, such as older people, people who have learning difficulties and people from minority ethnic groups, can provide new and challenging research opportunities (Reid et al., 2001; Kai and Hedges, 2001; Tetley and Hanson, 2000). This can lead to the development and use of methodologies which extend the researchers' repertoire. When Tighe and Biersdorff (1993) carried out a research consultation exercise with people with learning difficulties and their carers, a clear preference was articulated for a participatory research model with people who have learning difficulties as part of the participatory research team. Consumers requested that the research generate options to choose from, rather than definitive answers, and the authors noted the possibility of a reciprocal relationship between research and practice.

Conceptual and practical issues

Despite the clarity of the directive to involve consumers in research, the initiative is complex and challenging. There may be

Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

resistance from researchers who doubt the ability of consumers to contribute in a meaningful way to academic research (Oliver, 2001). Consumers themselves may not feel able to participate authoritatively within methodologies with which they are unfamiliar. Conversely, there is a danger of consumers becoming ``professionalised'', losing the edge to challenge and question researchers (Oliver, 1997). Funding bodies may not be aware of the need for additional costs, such as creche or carer fees, without which consumers might be disenfranchised from taking part. Special care is needed to ensure that expenses do not conflict with benefit regulations. Commissioners of research may not acknowledge the extra time needed to provide mentoring and training, and to respond to consumers' suggestions, which could entail redesigning the study. The consumer One of the most complex issues in consumer involvement in research is the notion of ``the consumer''; what is the correct terminology to use and who is the consumer? There is no agreement in the literature on the use of the term. Commonly used words to describe a person who receives health care include ``patient'', ``client'', ``user'', ``service user'' and ``lay person''. Herxheimer and Goodare (1999) noted that these descriptors convey different meanings to people according to circumstances. As the terms usually refer to roles, rather than discrete types of people, individuals may have many overlapping roles. The language used to describe consumers reflects values and relationships with health care systems (Bastian, 1995), and is associated with fundamental issues about the nature of the consumer involvement process itself. Traditionally, the term ``consumer'' has been associated with a market approach to health care, with an emphasis on personal choice, while ``user'' is more closely linked to citizenship and issues of empowerment (Pilgrim and Waldron, 1998). Researchers need to be clear about the way in which they wish to involve consumers in research, to avoid misunderstandings about consumers' roles and responsibilities (Grant, 1997). The choice of methodology can be linked to how the consumer is perceived, with participatory research usually associated with empowerment objectives (Tetley and Hanson, 2000; Macaulay et al., 1999). 94

Little was known about the extent to which consumers are involved in NHS research until Dixon et al. (1999) produced a national database of 403 consumer involvement initiatives. The authors anticipated that a conceptualisation of consumer involvement would evolve during the construction of the database, but this did not happen. Instead, many complexities were encountered about who is the consumer, the nature or type of consumer involvement, the stage of consumer involvement, and appropriate models of research. Whether or not there is agreement about the term ``consumer'', there is a choice of whom to involve in the research process. Should it be a consumer who is a service user, carer, advocate, informal or formal representative? The answer will usually depend on the specific nature of the research, and what is expected of the role of the consumer. There has been much debate about the issue of consumer representation, with some authors advocating that consumers should be chosen by, and be accountable to, consumer groups (Bastian, 1998), while the legitimacy of consumers as individuals to contribute and articulate their experiences has also been presented (Entwistle et al., 1998). Models of consumer involvement A number of useful frameworks and models have been offered to guide researchers and consumers, providing conceptual clarity of key dimensions and goals of involving consumers in research: . Entwistle et al. (1998) outlined a framework comprising stages of the research process, possible consumer contributors and ways of identifying and involving consumers. . Dixon et al. (1999) offered classifications of the types and areas of consumer involvement, and developed a rating scheme to assess the extent of consumer involvement. . Hanley et al. (2000) have provided detailed guidance on reasons to involve consumers, types and levels of consumer involvement, stages and processes of involvement. Does it work? Despite being a national R&D priority, there is a paucity of studies of the effectiveness of consumer involvement in research. However,

Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

evidence is now emerging of the benefits of involving consumers in various research modalities. A national survey of consumer involvement in randomised controlled trials (Hanley et al., 2001) revealed that researchers who had included consumers were mostly positive about the process. Consumers had participated in nearly all stages of the research, and their roles in developing the trial protocols, shaping patient information and contributing at steering groups were perceived to lead to research questions of relevance to consumers, and more user friendly trials. Similar favourable findings were reported by Oliver (2001) who used a reflective approach to evaluate consumer involvement in all stages of the Health Technology Assessment (HTA) programme; identifying and prioritising research topics, commissioning and reporting research. The benefits of face-to-face discussions to identify research priorities were highlighted, also the capacity of consumers to develop research skills. A contributory factor to the success was the organisation being open to learning, and it was noted that ongoing effort was required to sustain the process. Participatory research is most strongly associated with consumer involvement, and the utility of this approach was identified by Macaulay et al. (1999) in a review of international projects. The benefits included improved health outcomes, increased local knowledge and capacity, and economic gains. Future studies are likely to exhibit increased rigour in evaluating the policy, as:
. . . the challenge now is to conduct research to identify whether their [consumer] involvement leads to actual, rather than merely perceived, benefits for research processes and output (Hanley et al., 2001).

Defining our terms Consumers in NHS Research (1999) consider consumers to be:
. . . patients, carers, long-term users of services, organisations representing consumers' interests, members of the public who are the potential recipients of health promotion programmes and groups asking for research because they believe that they have been exposed to potentially harmful circumstances, products or services.

In the absence of any widely agreed terminology, this definition of ``consumer'' is used in this paper. Consumer involvement refers to an active role in the research process, in contrast to the traditional use of consumers as the subjects of research. Three levels of consumer involvement have been identified. These are: (1) user control, where consumers design, undertake and disseminate the results of a research project; (2) collaboration, which involves an active ongoing partnership of consumers in the research process; and (3) consultation, where consumers are consulted with no sharing of power in decision making (Consumers in NHS Research, 1999). The above framework of consumer involvement was used in this study. We adopted the following definition of R&D provided by the Department of Health (1997), assuming that it would be most frequently used by NHS researchers: . designed to provide new knowledge; . whose findings are potentially of value to those facing similar problems elsewhere, i.e. it is generalisable; and . whose findings are planned to be open to critical examination and accessible to all that could benefit from them, i.e. public dissemination.

Given the policy directives from the Department of Health, we were interested to determine whether or not consumer involvement in NHS research was a reality. The objective of this study was to use a systematic approach to determine the extent and level of consumer involvement in health services research in one region in the UK. This paper highlights the concerns of researchers about involving consumers, and the difficulties in classifying consumer involvement in research. It also offers recommendations for NHS R&D management to support the process of consumer involvement in research. 95

Methodology
A number of approaches were used to identify current regional involvement of consumers in research; a survey of trust R&D contacts, scrutiny of ongoing and recently completed regional research initiatives via the National Research Register (NRR) (Department of Health, 2000a), the York University Database of Examples of Consumer Involvement in Research (Dixon et al., 1999), key Internet sites, and personal

Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

contacts. The latter comprised an interview with the deputy director of regional R&D, participation in a regional meeting at a national conference on consumers in research, and informal personal questioning of key researchers in the region. Despite cross matching, it is possible that some studies may have been overlooked. No independent verification of the self-reports has been undertaken (although research protocols were scrutinised when available and discussions took place with researchers where clarification was needed). However, these findings do give a good overview of the extent and range of regional R&D consumer involvement initiatives and raise issues worthy of wider discussion. Survey of trust R&D contacts A letter was sent to 66 R&D contacts (R&D managers, directors and co-ordinators), representing 33 trusts in a health region in England in 2000. A reply slip was included for people to indicate their interest in and/or awareness of consumer involvement in research within their organisation. A follow-up letter was distributed five weeks later to non-responders. All those who returned the reply slip were contacted to determine whether they were simply expressing an interest in consumer involvement in R&D or whether they were aware of any specific initiatives. In the latter case, a semi-structured telephone interview was used to obtain a brief description of trust-based research initiatives involving consumers and the level and stage of consumer involvement. Researchers were asked why they had involved consumers, and what training, mentoring and support were offered. Their opinions were sought on the term ``consumer'', and they were asked whether they had any concerns about involving consumers. They were also encouraged to raise any other issues of interest in relation to consumer involvement in research. When difficulties arose in contacting people by telephone, the information was collected via e-mail or letter. Decisions about whether the projects met the definitions of research and the specific levels of consumer involvement were made by the authors following discussions with the project researcher. 96

Searching research databases An information officer performed a systematic search of key research databases and Internet sites; the NRR (Department of Health, 2000a), the National Co-ordinating Centre for Health Technology Assessment, (NCCHTA) (National Co-ordinating Centre for Health Technology Assessment, 2000), the York University Database of Examples of Consumer Involvement in Research (Dixon et al., 1999), and the Department of Health Web site (Department of Health, 2000b) to identify regional R&D initiatives involving consumers. The NRR search was undertaken on the 2000 Issue 1 Internet version of the database. A combined medical subject headings (MeSH) and ``free text'' approach was adopted. Search terms included ``consumer participation'' (MeSH); and user, consumer and carer (as ``free text'' terms). The search was restricted to the NHS region in question, using the limit option. Personal approaches The regional R&D NHS executive office provided information about research projects involving consumers from two main sources: bids for regional R&D funding and NHS R&D funding trust reports. Both of these procedures specifically requested information from trust R&D departments about consumer involvement. Informal contact was made with R&D staff, and enquiries were made at the regional subgroup meeting of the NHS Executive national conference on consumer involvement in R&D, ``Research who's learning?'' (Consumers in NHS Research, 2000).

Results
Number of projects A total of 48 responses to the survey were received from, or on behalf of, the original R&D contacts giving a 73 per cent response rate. This represented 25 trusts (76 per cent of the trusts in the region). In addition, seven further contacts not originally sent a letter were identified as interested in this field. Of the total sample of 55 (which included the seven additional people identified), 53 people (96 per cent) stated that they were interested in the concept of involving consumers in the research process. Of these, 44 people (83 per cent of the sample), representing 17 trusts (68

Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

per cent of the sample), responded purely out of interest. This brief survey, therefore, revealed that only seven research teams (13 per cent of the sample), representing five trusts, less than a quarter of the trusts in the region, were actively involving consumers in the research process. Discussion with the regional NHS executive R&D office and our own contacts through the National Conference substantiated these findings. Interrogation of the NRR (Department of Health, 2000a) and searches on key Internet sites identified additional projects; however, none were conducted within the region under investigation. Taking all the search mechanisms into consideration, a total of seven research teams in five NHS trusts in the region met our criteria for actively involving consumers in research. Conceptual problems and practical difficulties During the telephone interviews it proved difficult for many researchers to understand the concept of consumer involvement in the research process. Most said they involved consumers, but on further probing it emerged that this was likely to mean consumers as passive subjects with no influence on the design or the course of the research. In some cases, when focus groups or in-depth interviews were employed, it was not easy to establish how actively consumers had influenced the research process. Many were unsure of the difference between research, audit and service development. Some questioned the utility of involving consumers in research, and asked if initiatives to evaluate the process had been carried out. Researchers, in particular R&D managers, expressed their concern during the course of the interviews about the practicalities of involving consumers: how do you obtain a representative consumer view? Does it matter how experienced consumers are in research terminology and design? How can differences in priorities between consumers and professionals be addressed? How can one ensure that confidentiality and data protection procedures are followed? Should consumers be paid, and if so, how much? Who provides funds for consumer involvement? 97

Characteristics of the projects involving consumers The research projects that had involved consumers were diverse (see Table I); addressing maternity care issues, cancer, disability, respite needs of people with dementia and their carers, and including Cochrane Collaboration research activities. The consumers were variously described as service users, advocates, representatives from voluntary or consumer organisations, carers and lay-members. We found consumers involved in research at all three levels: user control, collaboration and consultation. An example of user control was consumers identifying the need for research and deciding on the type of methodology. All but one project appeared to include collaboration at some stage of the project, with consumers contributing to the design or methodology of the study or initiating the research area. Consultation most commonly took the form of focus groups with consumers helping to identify research topics. Three projects arranged specific training on research methods. One provided Critical Appraisal Skills Programme (CASP, 2000) sessions on quantitative approaches to research and critical appraisal skills, with technical advice for consumers on how to frame research questions. Another made available workshops on how to formulate protocols, conduct the review process and carry out hand searches. A third provided training on field research issues in the form of role-playing scenarios. A fourth project ensured that consumers were aware of local courses on critical appraisal skills, and the fifth obtained training through Cancer Link. One project provided funds for replacement care cover, while carers were involved in research activities. When asked why they had involved consumers, one researcher's answer ranged from practical to philosophical reasons: ``To produce relevant research of the needs of women. Also, for philosophical and ethical reasons, in that it is ethically right for consumers to be actively involved in health research.'' The value of consumers in adding to the knowledge base was suggested, and another researcher mentioned the need to develop methodology to elicit the views of people with dementia. One respondent said simply ``we think they are essential''. All

Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

Table I Consumer involvement in research: project summary table Stage of research in which consumers were involved and types of influence Consumers on project steering group commented on all stages of the project Training/mentoring/ practical support offered to consumers Training accessed through CancerLink

Research activity 1a. A cohort study to evaluate the benefits and barriers to consumer participation in randomised control trials: focusing on breast cancer and lymphoma 1b. Development and field-testing of a uniform consumer held record for people with cancer 2. Evaluation of a strategy for services for younger disabled people

Consumer profile Two people with breast cancer and one person with lymphoma recruited from cancer support groups to the steering group

Level(s) of consumer involvement Collaboration

Person with breast cancer (same individual as in project 1a above)

Consultation

Consumer on project steering group of follow-up study. Design already developed

Training accessed through CancerLink

Consumer advocate on the project advisory group Disabled people involved in the pilot project

Collaboration with consumer representatives on the research committee Consultation with consumers in the pilot stage

Group discussions with consumers to help researchers define issues and refine approaches Draft topic guide for focus groups piloted and changed due to consumer feedback Consumer organisations helped to recruit focus group participants Consumer steering group member commented on all stages of the project 100 consumers were contacted to prioritise the themes from the focus groups

Consumers offered transportation to the venue Research meetings held in a building completely accessible to disabled people Consumers offered a nominal sum for participating, and funds for carer replacement cover No specific training or support asked for or offered. The consumer advocate was made aware of local courses on critical appraisal skills Consumer expenses built into the bid All consumers involved as field researchers were given training on health and safety issues; and field research issues in the form of role-playing scenarios All field research consumers supplied with a safety alarm Sessions were also held with field research consumers to discuss their expectations and concerns

3.

Determining the post-qualification and education needs of maternity care professionals

Consumer advocate on the advisory group Approximately 100 consumers with experience of maternity care

Combination of collaboration and consultation

4.

Evaluation of changes in maternity services

All consumers who were involved were women who were either mothers or pregnant Approximately 45 consumers actively involved None had been involved in research activity before

Combination of collaboration and consultation

Consumer steering group members commented on all stages of the project Five to seven consumers assisted in the collection of the data 30 consumers were consulted on the construction of the research tool - the pregnancy diary Research tool piloted on eight consumers, who were asked for their comments

(continued)

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Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

Table I Stage of research in which consumers were involved and types of influence The need for the research identified by a consumer organisation Three focus groups held to discuss consumers' needs to guide the research, to develop the research question and methodology Consumers were consulted about the interim report Consumers from voluntary organisations obtained funds for the study Consumer steering group members commented on all stages of the project Focus groups of consumers helped to guide the research and informed the researchers of important issues to include in the survey questionnaire Consumers participated in the following ways: Choosing topics for systematic reviews Writing protocols and undertaking the systematic reviews Refereeing protocols and reviews Hand searching the literature Being consulted before the review is published to ensure that the language is accessible and non-technical Participating at conferences and presenting papers Training/mentoring/ practical support offered to consumers Consumers attended two sessions provided by the critical appraisal skills program. The topics included quantitative research and appraising published research

Research activity 5. Users' knowledge, opinions and feelings concerning aspects of maternity care

Consumer profile Focus group participants were consumer advocates, voluntary group representatives of local maternity users' groups

Level(s) of consumer involvement User-led initially in terms of identifying need for the research Collaboration in refining research question and methodology Consultation thereafter

6.

Exploring the support/respite needs of people with dementia and their carers

Local heads of consumer organisations on the steering group Interviews with people with dementia Focus groups and interviews with carers

Combination of collaboration and consultation

Focus group held at the same venue as the carers' support group Consumers given preparatory information and kept informed of the progress of the study

7.

A Cochrane Collaboration group

Collaboration Currently 24 active consumers; nine men, 15 women. Most recruited from support groups. Ages not known but many retired

Consumers can attend free workshops on how to formulate protocols, conduct the review process and carry out hand searching Consumers not paid but receive expenses to attend the annual meeting, conferences and workshops Ongoing support is provided, particularly IT support

projects but one specifically mentioned the need to ensure that consumers' research needs were being addressed. In the remaining project it was the consumer organisation that insisted on becoming involved. A number of difficulties or concerns were mentioned covering a wide range of issues. Problems were encountered in recruitment, with 500 letters having to be sent out to 99

engage 28 participants in one project. The need to recognise people's varying health status was mentioned, also the issue of potential difficulties in having a consumer's health practitioner in the same meeting. One researcher talked of recruiting articulate and assertive consumers, but having doubts about whether or not they were representative. It was suggested that consumers who had

Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

adverse health care treatment often seem attracted to take part in projects, leading to a ``them and us'' relationship. The difficulties of eliciting the views of people who are not part of formal groups were also mentioned. Two projects included consumers with severe disabilities, and the researchers talked of the challenges in engaging consumers in a respectful and meaningful way. The researcher/consumer interface was discussed by one researcher, who talked of ``the difficulty in preventing professionals from appearing like members of a club, which can be alienating for consumers''. Suggestions to avoid this included minimising jargon, and letting consumers know why they are uniquely placed to contribute to the research. The importance of making the consumer feel valued and involved, and ``uniting behind a common purpose'' was stated by another researcher. Other issues mentioned were: the need for considerable time and effort to support consumers in the research process; costs, which might include transport and carer fees; and care taken with payment in relation to benefits. There was little enthusiasm for the term ``consumer''. According to one researcher, ``the word `consumer' implies the doctor is running a supermarket'', while another was unhappy with the term ``because it sits with the language of buying and selling, and seems inappropriate for the types of relationship which exist in the health service''. Another researcher did not like the term consumer, ``because it suggests people have choice, whereas they often have no choice in the service they use''. One researcher objected to using the term ``consumer'' because it ``implies the purchase of a commodity'', and was also uncomfortable with the use of the term ``lay'' ``as it implies a passive, non-expert person''. She suggested using ``the term that best conveys the active engagement of people taking part in the research''. In one project the term ``consumer'' was chosen by consumers. While acknowledging that ``the term `consumer' has connotations of going to the supermarket'', another researcher of maternity issues said the word ``patient'' was disliked because it had overtones of sickness and disempowerment. ``User'' was rejected because of associations with substance misuse, ``So the word `consumer', although not ideal, does cross the divide between sickness and health''.

Discussion
This study of one health region revealed that there is much interest in the concept of consumer involvement in research in the NHS; however, the number of projects actively involving consumers appears to be small. Consumer involvement in NHS research is not fiction, but it appears to be at an early stage of implementation, with few researchers confident about carrying it out, and much uncertainty about the defining of terms. In particular, it proved difficult for both the researchers and the authors to categorise the level of activity of consumer involvement, despite the conceptual framework offered by Hanley et al. (2000). The boundary between ``collaboration'' and ``consultation'' was not easy to determine in practice, and the way in which focus groups were regarded reflects this complexity. For some researchers, the objective of engaging focus groups was to provide data, while other researchers specifically recruited focus group members as research partners, to guide the research process. When interactions with consumers, e.g. focus groups, were used to inform the research design, we regarded consumers as being actively involved in research. If consumers were involved as providers of research data only, we did not consider this to be active involvement in research. We deemed ``collaboration'' to be an ongoing partnership which was reciprocal, in contrast to ``consultation'', which did not necessarily imply reciprocity. There were 12 projects initially identified as involving consumers in our study. When research protocols were received and interrogated for references to consumer involvement, it was apparent that only seven research teams were engaging consumers in an active role, consistent with our adopted framework. We recognise that our judgements were subjective. A limitation of this study is that the focus was on NHS trusts, and we have, therefore, not explored research in other areas in the region, such as primary care, social care and public health. We may also have inadvertently excluded research in some trusts, despite using multiple search methods. Similar difficulties in classification were reported by Dixon et al. (1999), who noted that the same type of research activity may be

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Consumer involvement in health research: fact or fiction?

R. Telford, C.A. Beverley, C.L. Cooper and J.D. Boote

British Journal of Clinical Governance Volume 7 . Number 2 . 2002 . 92103

classed as involvement in one study, but not in another. The definition of research used in this investigation is more stringent than that of Dixon et al. (1999), who deliberately chose a broad view of ``consumer involvement'' and ``research'', to produce an inclusive database of consumer involvement in research at an early stage of the development of this field. We agree with Dixon et al. (1999) that further classification and refinement of models of consumer involvement is needed. Improved clarity of the definitions of levels and stages of involvement and some consistency in the use of terms is likely to help researchers, clinicians and consumers to identify appropriate methods of involvement. The Department of Health (2001) has recently given an example of how one dimension, the stage of consumer involvement, can be routinely assessed and monitored. The checklist of questions to assess compliance with the standards set out in the research governance framework (DoH, 2001) enquires about consumer involvement at three stages: in protocol development, in the execution of R&D and in review and dissemination of outcomes. Searching for consumer involvement in electronic databases, such as Medline (Medline, 2000) and the NRR (Department of Health, 2000a), is time-consuming because of the high recall to precision ratio. For example, the ``scope note'' for the MeSH term ``consumer participation'' is very broad covering community action, consumer involvement, consumer participation and public participation. Until it is widely regarded as good practice for researchers to involve consumers, and also to describe the process more clearly, it will continue to be a laborious process to identify specific categories of consumer involvement in research. Dixon et al. (1999) noted that current conventional formats for academic papers do not invite descriptions for consumer involvement, even when this has taken place, thus limiting the impact on practice. The importance of ``learning from each other'' has been illustrated by a number of authors in this field (Hanley et al., 2001, Oliver et al., 2001). While the researchers we interviewed did not appear to welcome the term consumer, no favoured alternative was offered. The broad definition used in this study encompassed the different types of consumers recruited to the

projects. Concerns were expressed about involving consumer representatives who may not reflect the views of other consumers, and the difficulty in reaching those who choose not to join formal consumer groups was noted. Having the scope to increase the number and type of consumers as research partners, and/or being able to consult more widely and in different ways, are suggestions to overcome this possible bias. Whom to include, how, when and why, may need to be negotiated on a case-by-case basis by researchers and consumers depending on the research aims. There are lessons to learn from methods of health needs assessment, and Jordan et al. (1998) have highlighted the importance of the quality of the procedures used to consult consumers. They have discussed the shortcomings of one-off consultations, and emphasised the need to take into account whether consumers are informed or not, and if they have had the chance to deliberate and discuss issues with others. The authors present a range of methods of public consultation, and point out that assessments may produce different and conflicting needs. Training and support emerged in this study as important factors to consider when involving consumers. One researcher observed that she needed to spend a great deal of time boosting consumers' confidence, as well as providing practical support. Oliver (2001) has pointed out that reading some reports can be an emotional experience for consumers, which should not be underestimated. The authors also reflected that the process of involving consumers in research has implications for skill development of researchers too. It is noteworthy that in our small sample, three projects were in maternity services. This may reflect well organised consumer bodies associated with this health area, that keep members informed of prospective research, and have the ability to respond swiftly to requests for consumer participation. We did not interview the consumers involved in the research projects identified by our survey, and view this as an important omission, as it would have been illuminating to have compared the views of researchers and consumers.

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Conclusions
During the course of this study, we encountered much enthusiasm for involving consumers in research, many questions about how to do it, but few local examples to draw on. Enthusiasm to include consumers can be limited by many daunting complexities about the procedures for involving consumers in the research process. Some of these queries have been addressed in policy, guidance and research documents (Hanley et al., 2000; Department of Health, 1999a). Findings from this study suggest that involving consumers in research requires commitment, expertise, resources and entails a certain degree of risk. The authors propose that trusts and R&D management take an active role in supporting researchers to involve consumers in research, rather than leaving the responsibility to individual interested researchers. Trusts may facilitate involvement of consumers by: . identifying local expertise through the registration of past or current initiatives involving consumers and staff with experience in this area; . promoting the concept of consumer involvement and ensuring awareness of the implications, guidance and available local expertise; . ensuring commitment to the process at the highest level within the trust with a recognition of the resource implications, ethical considerations and risks; . identifying a budget for consumer fees and expenses with clear guidance for its use; . making staff training opportunities available, and identifying and meeting the training needs of consumers.

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