Debra Bick and Ian D. Graham
- There is increased recognition that the involvement of service users in the design, content, and evaluation of health service provision is essential to achieve and sustain high-quality health care.
- Service user involvement in all stages of the research process is now also viewed as essential. Many funding agencies require that service users are equal partners in funding bids.
- Evidence of the impact of greater involvement of service users in the planning, development, and dissemination of national policy and research priorities is evolving.
- The outcomes of evidence-based practice (EBP) from a service user perspective can reflect a spectrum of involvement from representation on an advisory group, involvement in decisions about day-to-day care or a decision to participate in a research study.
- There is an extensive and developing evidence base that describes how many different studies have involved service users.
Introduction
There has been increasing recognition over recent years that the involvement of health service users and their families, private and voluntary sectors, and wider public in the design, content, and delivery of health services is essential to achieve and sustain high-quality care. In parallel, users have become increasingly involved in different stages of the research process to inform findings which are relevant and appropriate for users (Staniszewska et al. 2007; Tarpey 2006). In some areas of health-care provision, most noticeably maternity care, there is a long history of the direct involvement of service users in the questioning of practice and policy, often as a consequence of views which differed markedly from accepted “best” practice at the time. An example of this was the widespread use of routine episiotomy in UK maternity care during the 1970s, which was purported by clinicians to have a number of advantages over restricted use, an assumed benefit questioned by women. Evidence from large randomized controlled trials (RCTs) which compared outcomes of restrictive with routine episiotomy showed no benefit from routine use (Carroli & Mignini 2008). Although change in practice in the UK and other English-speaking countries appears to have commenced prior to the publication of trial findings, this does not detract from the challenge study findings presented to the beliefs of maternity providers (Graham et al. 2005). That routine episiotomy persists in many developed and developing countries appears to be a consequence of health-care providers’ beliefs about the value of the procedure and women’s inability to give birth without surgical intervention (Graham 1996). It is also possibly because user involvement is not as widespread or proactive in these countries and because care is dominated by a medical model. This highlights the levels of complexity and influence of culture, context, and individual belief systems relating to use of evidence-based practice (EBP) and why harmful health practices persist while potentially beneficial practices are not universally implemented (McGlynn et al. 2003; Schuster et al. 1998).
As referred to in Chapter 2, EBP is a type of knowledge use, primarily knowledge derived from research, the outcomes from which can be divided into two broad categories: knowledge use and its impact. This chapter will outline the recent focus on service user involvement in determining the outcomes of EBP, initiatives to increase their contribution to health service policy and research and how their experiences of care are being captured and disseminated (the term service user is used throughout this chapter to include patients, their immediate carers outside of health-care professionals, and other commonly used terms such as health consumers). As this is a relatively new area, service user perspectives have not been reflected in the development of models and frameworks to support EBP although this situation is likely to change (Graham et al. 2006).
Enhancing the contribution of service users to health service policy and research
The role of national agencies
In the UK there was a noticeable shift in health service policy and research priority setting following the election of a Labour government in 1997 from a position of managing ill-health to a position of prevention of ill-health, including the need for individuals to take greater responsibility for their own health (Department of Health 1999). Although the success of this approach when viewed a decade later is debatable, it was in part a recognition that the NHS could not continue to provide full care and support to meet the demands of individuals with increasingly chronic ill-health. At the same time, evaluation of the impact of EBP from service users’ perspectives has been a growing area for research funders such as The National Institute for Health Research (NIHR) in the UK, who are increasingly asking for evidence of collaboration between researchers and users. There is also increased recognition that there has frequently been a mismatch between research that is funded and research that service users would like to see funded (Tallon et al. 2000). A range of initiatives have been established to find common ground in terms of priorities of importance for research from service users’ perspectives. One important example is the James Lind Alliance (JLA) which was established to help identify and address uncertainties about the effects of treatment and facilitate the identification of research priorities shared by patients and clinicians (www.lindalliance.org).
In England and Wales, the national advisory group INVOLVE has been instrumental in ensuring users are engaged in all aspects of the research process. In addition other organizations such as the National Institute for Health and Clinical Excellence (NICE) have paved the way for greater involvement of service users and their carers, ranging from involvement in setting priority topic areas for clinical guideline development, membership of guideline development groups, membership of a Citizens Council to advise NICE decision making, and more recently in strategies to support and sustain the use of NICE guidance in practice. In the UK in 1998, the Healthcare Commission instituted four yearly annual surveys of patient experiences, and in 2001 introduced annual surveys of acute inpatient care. The UK NIHR has been pivotal in ensuring service user representatives are actively engaged as members of research teams contributing to the development, implementation, and evaluation of research commissioned across its funding programs. INVOLVE is funded by the NIHR to support and promote active public involvement in NHS, public health, and social care research (www.invo.org.uk). In England, the NIHR has also funded Collaborations for Leadership in Applied Health Research and Care (CLAHRCS) as a way of implementing research findings into practice, with nine CLAHRCs set up to date across the country. Their main role is to undertake high-quality applied health research focused on the needs of patients and support the translation of research evidence into practice in the NHS. CLAHRCS are collaborative partnerships between a university and its local NHS organizations, focused on improving patient outcomes through the conduct and application of applied health research.
Similar moves to enable those who use the health services to contribute to the development of health service policy, research priorities, and dissemination of findings have been undertaken by bodies tasked with leading national funding priorities in other parts of the world. The Canadian Institutes for Health Research (CIHR) created a conceptual framework for Citizen Engagement which is intended to guide the agency’s efforts to meaningfully engage the public in research processes including priority setting. In the USA, service users can receive e-mail updates on a range of work undertaken on behalf of the Agency for Healthcare Research and Quality (AHRQ), including flyers on aspects of health management and work undertaken as part of AHRQs Knowledge Transfer/Implementation Program. The National Health and Medical Research Council of Australia (NHMRC) produces a range of information for service users using media which includes podcasts, guidelines, and health facts on different health priorities. The NHMRC also works with The Consumers Health Forum of Australia to inform how service users can be included in research.
As much of this work is relatively recent, evidence of the impact of greater involvement of service users in the planning, development, and dissemination of national policy and research priorities is evolving. Staniszewska (2008) highlighted some of the key limitations of this evidence base including differing terminology, poor conceptual or theoretical underpinnings, limited understanding of the concept of impact in this context, and mainly descriptive accounts of impact with little robust measurement. Oliver and colleagues (2004) developed a framework to inform a literature review of how service users were being used in research identification and prioritization in England, identifying data from several sources, including electronic databases and interviews with service users and research program managers. Of 286 documents identified which specifically referred to service users in identifying or prioritizing research topics, most (n = 91) were general discussion documents, some of which included a theoretical analysis or a critique of research agendas from a consumer perspective, 160 reported specific efforts to include consumers in identifying or prioritizing research topics, and a further 51 reported consumers identifying or prioritizing research topics in the course of other work. Most of the literature comprised descriptive reports by researchers who were key actors in involving consumers. The authors concluded that if service users are to be engaged, appropriate skills, resources, and time are essential to develop appropriate working practices. The potentially beneficial impact of user involvement in the research process was outlined by Staniszewska et al. (2007) who described the way in which parents influenced the focus of The Parents of Premature Babies Project (POPPY) which undertook research into aspects of neonatal care and provision of services important for the parents of premature babies in terms of aims, methods, ethical aspects, and dissemination. POPPY findings have been submitted to the UK Neonatal Task Force where it is hoped that the model of family-centered care proposed by the study will influence future care provision.
Nevertheless, as Black and Jenkinson (2009) highlight, a number of challenges remain. These include how to engage service users at the outset, what approaches to use to measure service users’ experiences and outcomes of care and need to consider methodological issues, practical considerations, and ensure data of interest are the most relevant for the service user. Some of these challenges are addressed later in this chapter.
The role of service user groups and networks
Input by service users into the work of national agencies in some countries has undoubtedly been influenced by the growth of voluntary and peer advocacy or support groups, established to promote networking among members with the same health problem (e.g., local breast cancer survivor groups), to coordinate lobbying for policy or service change to reflect EBP and user views (e.g., the National Childbirth Trust in the UK) or to coordinate and encourage donations to fund research to improve treatment, patient outcomes, and experiences (e.g., Cancer Research UK). Many groups use the internet to disseminate information, provide links to sources of support and advice and discuss results of latest relevant studies. In some middle-income countries, the importance of user involvement to achieve internationally established targets to improve country-level health is now apparent. For example, in Brazil, women’s groups have been actively engaged by national policy makers in work to improve birth outcomes, reduce unnecessary interventions during labor and birth, and highlight where gaps in maternity and infant care practices persist in order to achieve the Millennium Development goals (Diniz et al. 2007). The Health Technology Assessment International Programme has established an international Patient and Public Involvement Group to support those doing research in the field. Further information can be obtained from their web site (www.htai.org).
Defining EBP priorities and outcomes from a service user perspective
The impact and outcomes of EBP from a service users’ perspective needs to reflect a spectrum of involvement from representation on an advisory or service user representation group, to an individual’s involvement in decisions about their day-to-day care and management, to or a decision about participation in a research study. The following sections describe impact from a range of perspectives from the macro to the micro-level.
Engagement in priorities for EBP
Despite the growth in service user support groups, “grass-roots” initiatives and role of national agencies to support user involvement, there was until fairly recently a dearth of information on how user perspectives of the outcomes of EBP could be gauged and utilized to sustain and support change, with little debate or dialogue as to what “research,” “evidence,” or “impact” mean from the perspective of service users. In the UK there was previously little formal advocacy of how to engage users in research and little reference, if any, in published research reports of how or if service users had been involved (Hanley et al. 2001). Indeed there was no information on the type of involvement or extent of involvement of service users. A UK survey of 62 clinical trials offices and support units on user involvement between 1990 and 1998 found that 23 centers reported that users had already been involved, with most positive about their involvement (Hanley et al. 2001). Of the remaining centers, 17 reported that they had plans to involve service users and 15 had no such plans although only 4 considered their involvement irrelevant. This was the first UK national survey of service user involvement and it highlighted a number of issues including some confusion as to the role users should play and indication that in the main, users contributed to the content of patient information leaflets.
Nearly a decade later there is an extensive and developing evidence base that describes how many different studies have involved service users, for example, INVOLVE maintain a bibliography of relevant studies (www.invo.org.uk) although how to ensure service users are engaged in the identification of research priorities needs further consideration. Stewart and Oliver (2008) conducted a review on behalf of the JLA which considered patients and clinicians research priorities. They developed a framework to identify reported priority setting activities, supported with specialist software. Overall, 258 studies were identified for inclusion, 148 of which reported patients or clinicians engagement with research; 61 of these studies (41.2%) only described broad research areas in terms of populations (5/61), interventions (11/61), outcomes (20/61), or broad research topics (44/61); 96/148 (64.9%) reported patients’ or clinicians’ identifying research questions; 5/148 (3.4%) reported patients’ or clinicians’ views on research measures. Clinicians were more likely to be engaged in the identification of clinical research priorities (131/148 studies compared to 27/148) despite policy support for patient and public involvement.
Engagement in identification of outcomes of EBP
In more recent years there has been growing interest in understanding how knowledge derived from research is disseminated and used in non-academic contexts, with drivers for this change arising from political imperatives, recognition that research-based knowledge has had little impact and need for research funders and advocates to increase rigor in the direction and design of research (Davies & Nutley 2008). Empirical studies of the impact of research which aimed to ascertain how and where the findings of research have been used have tended to focus on positive outcomes for the group targeted by the intervention—for example, a reduction in maternal perineal pain at 10 days as a result of using vicryle rapide suturing material rather than chromic catgut (Kettle et al. 2002). However, what we tend to find is that these outcomes are often imposed from the perspective of the researcher or clinician; they tend to be based on short-term follow-up and rarely take account of the perspectives of the service user. Growing evidence illustrates important discrepancies that exist between health professionals and patients with regards to the way in which a “good outcome” is defined (Hewlett et al. 2005). Outcomes on the whole tend to be quite narrow, do not take account of the consequences for the service user or consider other direct or indirect consequences of the change in practice, including impact on other areas of health-care provision. One example of this was early consensus work to identify important core health domains for the assessment of rheumatoid arthritis which included only clinicians, researchers, members of pharmaceutical companies and economists in the decision-making process (Felson et al. 1993). Pain was identified as a primary outcome. More recently, patients have been involved in this process, and although pain remains an important outcome, fatigue and general well-being are additional outcomes that had not previously been considered (Carr et al. 2003; Hewlett et al. 2005).
The gap between what a “good” clinical outcome means from a health service provider or policy perspective (usually a change in practice which leads to care which is clinically and cost-effective— for further information refer to Chapter 8) and what a “good” outcome means from the perspective of a service user persists. There may also be debate as to why service user views are important, as it is usually the clinician who makes the final decision about the content of care, as Diane Doran refers to in Chapter 4 which describes an outcomes framework. Nevertheless, as Diane also points out, if service user views of outcomes are not collated, clinicians will operate in isolation from knowing if or how their care is effective or resulting in potential harm and greater resource use.
A large UK wide matched pair cluster study (The PEARLS study: www.rcm.org.uk) which aims to improve the assessment and management of perineal trauma following birth included a Delphi study and consensus conference to identify what outcomes women who had sustained perineal trauma considered to be important at different times in their recovery after giving birth. Previous trials of perineal care outcomes, for example, use of different suturing methods and/or suturing materials have tended to use pain as a primary outcome measure, either as a “generic” measure or in relation to a specific activity, for example, resumption of sexual intercourse (Kettle et al. 2002). The PEARLS trial team invited women who had given birth within the previous 6 months at two units not participating in the trial to participate in a social event to take part in a “Who Wants to be a Millionaire” voting process to identify the most important outcomes to them following perineal trauma at 1 week, 2–4 weeks, and 3 months after giving birth. At each event, women were asked to score on a scale of 1–6 using an electronic key pad, how they would rate each of 44 outcomes following perineal trauma by order of importance (1 being not important and 6 being very important).
Of note was that women at both sites did not consider pain outcomes to be the most important issue for them. That their perineal tear or episiotomy did not become infected was women’s most important concern at 1 week after the birth. This finding was reflected in the trial as a secondary outcome measure, as lack of routinely collated data on incidence and onset of perineal wound infection meant it could not be used as a primary outcome measure, with sufficient numbers to power the study (see PEARLS protocol, www.rcm.org.uk). Inclusion as a secondary outcome will provide the first evidence of incidence of perineal wound infection within 3 months of birth at a national level which could inform future work. This example illustrates that service users can present a very different perspective on what is important for their health and well-being than that assumed by the researchers, clinicians, and health service providers.
Patient-reported outcome measures
In addition to the need to consider how service users can be involved in the identification of priority topics and outcomes of EBP, there has been a significant growth in the development and use of instruments more recently referred to as patient-reported outcome measures (PROMs) (Patrick et al. 2007), to assess the impact of implementation on service user outcomes. The following sections outline some of the PROMS developed and related issues with respect to their use. Some have been developed to assess impact on general health and wellbeing, whereas others have been developed to assess a particular condition or procedure (Garratt et al. 2002). Of note is that collation of evidence of service user outcomes tends to be purported to be used as feedback to clinicians and service providers (e.g., through audit) with the expectation that it will improve future health outcomes and quality of care—the extent to which findings are used to improve the current health and well-being of the individual respondent is less clear.
Service user reported outcomes of care
When assessing the impact of an intervention to implement EBP, the researcher or clinician can make a number of subjective or objective assessments of “benefit.” However, it is the individual who has been the recipient of the intervention who can provide a unique insight with respect to the impact of an intervention on their own physical or emotional well-being, their quality of life, and experiences. The issue for use of EBP is how this evidence is used and how to ensure the service user’s perceptions of what is important to them is captured as highlighted earlier.
Growing interest in capturing the patient perspective of ill-health and the relative impact of health care has resulted in the development of several hundred instruments that purport to capture the patient perspective (Garratt 2009; Garratt et al. 2002). Variably referred to as measures of quality of life, health-related quality of life, or health status, more recent guidance adopts the term Patient-reported Outcome Measures (PROMs) (Patrick et al. 2007). Well-developed PROMs, usually self-completed questionnaires, aim to provide a systematic and structured assessment of the patient’s perspective across a range of health concerns, from symptoms and physical functioning to well-being and quality of life (Fitzpatrick et al. 1998).
There are two broad categories of PROM: generic and specific. Generic measures are not age-, disease-, or treatment-specific and contain multiple concepts of health-related quality of life relevant to both patients and the general public, supporting their application in both population groups (Garratt et al. 2002). Population-based normal values can be calculated which supports data interpretation. There are two classes of generic measure: health profiles and utility measures. Examples of widely used generic health profile and utility measures are the Short Form 36-item Health Survey (SF-36, Ware & Sherbourne 1992) and the EuroQoL EQ-5D (EuroQoL Group 1990; www.euroqol.org) respectively.
Historically, PROMs have been used in clinical trials and research settings. However, growing interest in capturing the patient’s perspective in a routine practice has been fueled by suggestions that the value of health care remains unclear until its impact and effectiveness is assessed using outcomes relevant to patients and health professionals (Department of Health 2008a). This led to the recent implementation of specific PROMs within the NHS. From 2009, the Department of Health in England has required all providers of elective surgery for NHS patients to use PROMs data to assess the outcomes of four commonly performed elective procedures: hip replacement, knee replacement, groin hernia repair, and varicose vein surgery. The EuroQoL EQ-5D is the recommended generic measure, to be used alongside specific measures for each condition: the Oxford Hip Score (Dawson et al. 1996), the Oxford Knee Score, and the Aberdeen Varicose Vein Questionnaire;
Improvement in clinical quality and outcome is at the heart of current NHS reforms in England:
“Effectiveness of care. This means understanding success rates from different treatments for different conditions. Assessing this will include clinical measures such as mortality or survival rates and measures of clinical improvement. Just as important is the effectiveness of care from the patient’s own perspective which will be measured through patient-reported outcomes measures (PROMs)…”
High Quality Care for All: NHS Next Stage Review (Department of Health, 2008a)
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