The idea of involving patients and the public in health care has grown significantly in recent decades and is now enshrined in health policy across a range of international settings.[1-5]
Therefore, patient and public involvement (PPI) has increasingly become the focus of attention in health services research and health services development. Thompson et al. argue that these are overlapping categories whereby data generated by such research can inform and improve health-care services. There are a number of models or frameworks that aim to conceptualize public and patient involvement (PPI). Gibson et al.'s recent work on conceptualization of PPI provides a valuable overview of models and frameworks in the field, and provides new theoretical directions (that were previously absent) for an emancipatory concept of patient and public involvement in health services development. A systematic review by Brett et al. focused on the conceptualization, measurement and impact of outcomes of PPI in health and social care research.
However, conceptualization and theorization of PPI is not common in studies of PPI. Furthermore, there have been recent important developments in the operationalization of public and patient involvement in health research and health service development. Earlier literature in the field proposed that involvement could be captured through the use of conventional health service research methods such as surveys, in-depth interviews and general consultation. It is now accepted that these methods, by themselves, do not facilitate meaningful involvement unless service users have contributed to research design. This emphasis on more extensive involvement is captured in the www.involve.org.uk INVOLVE definition of involvement in health research and health service development as research ‘with’ or ‘by’ service users, rather than ‘to’, ‘about’ or ‘for’ service users (see www.invo.org.uk).
There have been examples of concerted efforts to develop infrastructure and capacity to support meaningful collaborations and partnerships between academia, health-care providers and patients in North America (see http://pram.mcgill.ca/) and the United Kingdom (see http://piiaf.org.uk/).
However, problems persist in the field. Firstly, there is a problem of definition. There is still a wide range of terms used in the field, including patient involvement, patient engagement, patient participation, service user involvement, citizen engagement, community participation, community engagement and public involvement. Gallivan et al. argue that this can contribute to misunderstanding and misinterpretation of expectations, goals and outcomes by different groups of stakeholders, which poses barriers to achieving meaningful and successful outcomes in partnership work together. We clarify our terminology in Box 1.
Box 1. Terminology: service user involvement
In this paper, we employ the term Service User Involvement (SUI) because this is the terminology employed by the Health Service Executive (HSE) in Ireland in its Strategy for Service User Involvement 2008, and the research reported here is designed to inform our national policy context as well as informing international debates. In the Irish context, the term SUI refers to ‘a process by which people are enabled to become actively and genuinely involved in defining the issues of concern to them, in making decisions about factors that affect their lives, in formulating and implementing policies, in planning, developing and delivering services and in taking action to achieve change’.[3, 6] The term SUI was chosen from a variety of options (e.g., engagement, public participation and community participation)[4, 5, 8] as a workable rather than ‘perfect’ definition.
Secondly, there are many reasons why service users and health professionals get involved with service user involvement (SUI) projects. This presents the problem of enrolment in the field.[6, 13-15] We do not know what factors motivate health professionals or service users to enrol in specific projects: Is it a question of personal motivation or is it a response (voluntary or involuntary) to policy directives? Are service users and health professionals enrolling with shared or differential motivations and definitions of involvement?
Thirdly, there is the problem of enactment. As above, standard conventional research methods can be mistakenly conflated with SUI. It is important to know why a specific method is selected for a project and whether the selected methods are congruent or not with an intended level of involvement and working definitions of service user involvement in health research and/or health service development.
National and international literature reviews of the field have highlighted that it is very possible for health-care professionals to be ‘engaged’ in numerous purported involvement activities with service users without genuinely involving people (particularly if the professionals continue to set and drive the agenda and make decisions about services and treatments without involving service users in a meaningful way).[8, 17] This has implications for understanding the outcomes of SUI, which is the fourth problem – appraisal of SUI. While negative effects of SUI on research processes and subsequent health service outcomes have been reported,[9, 18, 19] there is growing evidence that participatory approaches to research that involve service users in a meaningful and sustained way can have positive impacts in terms of setting the research agenda, programme sustainability and advancement, the generation of systemic change,[17, 20-22] and on service users themselves.[23-26] Therefore, we have to seriously and critically analyse any claims about outcomes based on SUI where, in fact, service user involvement did not occur or was so poorly enacted that it ought not to be claimed as genuine service user involvement.
Overall, our observation is that the four problems outlined above are problematic in and of themselves, but they are also barriers to the implementation of meaningful SUI as a routine way of working in health-care research and health-care service settings, that is as a normalized practice. The problems are about the definition, enrolment, enactment and appraisal of SUI, and these resonate with the four constructs of Normalization Process Theory (NPT) (see Table 1). This is a contemporary social theory that can be used to understand and investigate the normalization of innovation in health care.
|How is service user involvement defined?||Definition||Coherence|
|Why do stakeholders get involved?||Enrolment||Cognitive Participation|
|What methods are used?||Enactment||Collective Action|
|What are the outcomes?||Appraisal||Reflexive Monitoring|
The aim of this review was to critically interrogate the conditions for the implementation of SUI in both primary care research and health service development projects to make recommendations that will enhance chances of its normalization. We focus on a sample of original published empirical work that is reported as SUI in the primary care literature to rigorously examine the way definition, enrolment, enactment and appraisal are reported vis-à-vis each other.
The methodological approach for conducting this review followed the broad precepts of a critical interpretive synthesis (CIS). We employed an inductive and iterative approach using the research question as a compass during the review process. We sought a purposeful sample of papers, integrated quantitative and qualitative data, and aimed for a more fundamental critique of literature (rather than a summary). While we adopted an inductive approach at the outset of the review process, given our interest in implementation and normalization, we used NPT as a heuristic device to synthesize emergent findings and draw out key recommendations.
The research team constituted academics, health authority personnel, clinicians and community organization representatives, all of whom have experience of using participatory research approaches.
We searched EBSCO host for original primary care papers about research and health service development projects that were identified by relevant search terms between 2007 and 2011 (see Fig. 1 for description of search terms).
The first stages of the review involved an iterative reflexive approach to searching and sampling the literature using a series of identification, sampling and appraisal steps as per the CIS methodology. Each of these stages of the review was led by the first author with substantial input, independent reviewing of abstracts and development of sampling parameters by the second and last author, and consultation with the other authors. The thematic analysis and subsequent synthesis of findings was led by the first and last author in consultation with all other authors, using a combination of data analysis clinics, project meetings and email correspondence.
We identified 289 abstracts at the outset, which resulted in 234 abstracts after duplicates were removed. From this, 78 empirical abstracts were identified, and using iteratively developed sampling parameters, we excluded conventional qualitative research studies and selected a final purposive sample of 26 papers for inclusion in the review (see Fig. 1).
Not all papers included in the review involved service users in a meaningful way as per the definition espoused by INVOLVE, but we included them on the basis that they were identified in the literature as SUI. Our search terms therefore represented ‘current practice’ reported in peer-reviewed published literature. They were included because they contained at least some data about definition or enrolment or enactment or appraisal of SUI. For example, the work was presented as SUI in the introduction section against the policy background of SUI, or the work reported revealed proximity between data generation and health-care service outcomes, which we considered relevant to understanding the impact and appraisal of SUI.
Table 2 provides an overview of the final set of sampling parameters and the numbers of papers reviewed per parameter. Following Dixon Woods, and using checklists developed by others,[30, 31] we conducted a quality appraisal exercise on these 26 papers with an emphasis on the relevance of the paper to our review. All were deemed appropriate for inclusion in the review.
|n = 8 – SUI studies explicitly reporting experience of ‘doing service user involvement’ and/or studies that demonstrate high-level involvement using participatory methodologies|
|n = 3 – Qualitative and quantitative health services research (HSR) studies that focus on the perspective or experiences of service users, with more of an emphasis than other HSR studies on reporting outcomes or actions taken as a result of their input|
|n = 5 – Qualitative and quantitative health services research studies on the theme of SUI and/or patient participation|
|n = 2 – Studies with a focus on shared decision making, including studies that analyse patient/practitioner consultations in which there is shared decision making|
|n = 4 – Randomized controlled trials where the intervention component has some evidence of patient involvement, for example learning skills for self-management, participation in mentoring or coaching|
|n = 4 – LLIrish papers (including grey literature) focusing on user involvement in primary care in the Irish context, as recommended by our research team to ensure our review (a) had relevance to the national policy context and (b) was inclusive of studies with participatory methodologies, which were under-represented at one point in the sampling process|
For the data extraction process, we used a modified version of the critical appraisal tool (CAT). Our process and working definitions for the synthesis are shown in Box 2. First-order constructs were drawn from the information extracted during the critical appraisal process and were informed by the items on the amended CAT (see Table 3, Column 1). All papers, qualitative and quantitative, were appraised by the same method.
|1. Socio-political context or drivers|| [33, 49, 66] ([34, 50]) ([36, 39]) ()  ()     [45, 53]  [38, 56]||1. Control and Power||[33-35, 41, 45, 46] ([38, 43, 50, 52, 69]) [56, 68] [37, 40, 44, 55]||1. Definition|
[40-45, 50, 55] [33, 34, 70] () 
  
|2. Definition of service user involvement||(  ) ( [34, 36, 38] )||2. Dialogue and communication||[33, 41, 45] [39, 43, 69] ([36, 49-53, 56, 66-68])||2. Enrolment||() [40, 41]  [43, 44]  |
|3. Level of SUI||[33, 49, 52, 66]  ([34, 36, 39, 50, 67, 68])   [45, 53]  ||3. Ethical Practice||[33, 35, 41, 45]  ([39, 43, 69]) [36, 49-53, 56, 67, 68]||3. Enactment|
[33, 52]  () [43, 45]
[47, 50, 51] ([49, 52, 53])  [41, 44]  [36, 55]   ()
|4. Recruitment||[33, 41, 49, 52, 66] ()  ([39, 67]) () [34, 50, 68]       ||4. Methods||[33-35, 41, 45, 46]  ([39, 43, 69]) ([36, 47, 49-52])  () [53, 56, 66] ||4. Appraisal||[33, 43, 51, 52]  [33, 50, 52]  [38, 40]|
|5. Training||[39, 66]  |
5. Partnership and Collaboration
Data for this construct were extracted from:
Theme 1 Socio-political context or drivers
Theme 2 Definition
Theme 3 Level of SUI
[33, 34] [35, 41, 45, 46]  ([39, 43, 69]) [36, 47, 50-52]
 () [56, 68]  [37, 40, 55]
|6. Ethics||[33, 49, 52] [35, 41]   () ([36, 46, 50, 68]) [45, 53]  ||6. Roles and responsibilities|
 ([34, 35, 41, 45, 46])
 ([39, 43, 69]) () [38, 47, 50-52] [56, 66]   [37, 55] 
|7. Methodological considerations||[33, 49, 52] [35, 41]  () ([36, 39, 50]) ([34, 68])  [46, 53]    ||7. **Standard practice||[33, 35, 41, 45, 46] [39, 42, 43, 69] () [36, 50, 51] [52, 67] [53, 66] |
|8. Dissemination||8. Other||([34, 35, 41, 45, 46]) ([39, 43, 69]) () [36, 50, 51] [47, 52]  ()   [56, 68]|
|9. Impact of SUI|
[33, 49, 52] [35, 41]  () [36, 39, 50] ()
       
|10. Evaluation of SUI||[52, 66] [33, 49]  ()  () () ([36, 50])|
|11. Other||[47, 68]      |
Box 2. Our working definition of first-, second- and third-order constructs (drawing on work of[63-65])
|First-order constructs||Information extracted during the critical appraisal process of reviewing the evidence in the literature for Service User Involvement in Primary Care Research and Health Service Development||Interpretations of what the literature tells us about Service User Involvement in Primary Care Research and Health Service Development|
|Second-order constructs||Interpretation and collation of themes from first-order constructs||Interpretations of what the literature tells us about Service User Involvement in Primary Care Research and Health Service Development|
|Third-order constructs||The views and interpretation of the synthesis team expressed in terms of themes and key concepts and mapped onto four NPT constructs||Interpretations of what the literature tells us about Service User Involvement in Primary Care Research and Health Service Development|
These first-order constructs informed the development of our second-order constructs through interpretation and collation of themes from first-order constructs (see Table 3, Columns 3 and 4).
Whilst we were reviewing our second-order constructs and the data contained therein, we were exploring the evidence from across all studies in the review to integrate this data into a synthesizing argument. Given our noted link between the practice of SUI and NPT's constructs, we developed a synthesizing argument around the theory's four constructs of coherence, cognitive participation collective action and reflexive monitoring (Table 3 shows how the data from each paper informed this final synthesis).
By mapping our first- and second-order constructs onto these synthesizing NPT constructs in a sequential manner, we were representing the network of synthetic constructs and explaining the relationships between them with the aim of providing a more insightful formalized and generalizable way of understanding a phenomenon – in this case, the phenomenon of Service User Involvement in Primary Care Research and Health Service Development. Therefore, the synthesizing constructs of NPT were informed by data from across the second-order constructs (which were developed from thematic analysis and interpretation of first-order constructs).
In the main, the second-order constructs which most informed the final stage of our synthesis and conclusions were partnership and collaboration, roles and responsibilities and power and control (See Table 4 below).
Partnership and Collaboration
Collaboration in health-care delivery
Collaboration in clinical consultation
Collaboration in research
The data in this theme relate to partnerships and collaborations for research and health-care projects. Data refer to the working relationship and style of working involved in partnerships and collaborations. Data also refer to working in a specialized way or with specialized roles within partnerships and collaborations
The data in this theme relate to where collaboration has happened and there is evidence of what happens when collaboration and partnership are in place. Data that describe partnership with service providers, partnership between systems (socio-political systems, health systems), communities and individuals were also included here. Data were included if they describe system-level changes that are required for partnership and collaboration to occur
Roles and Responsibilities
Diverse research roles
The ‘expert patient’ role
Roles in clinical interventions
The data in this theme refer to particular roles or responsibilities that were defined and described in the research paper. The focus is on actions and interactions by stakeholders in the research
These data relate more specifically to practice rather than rhetoric
Control and Power
The rhetoric of SUI
Issues of equity and human rights
Empowering research methods
|Data coded in this theme refer to issues of service user control, or lack of, in health-care settings or health-care research. Emancipatory methods used in research studies or in clinical collaborations to readdress the balance of power are described. The process and implications of rebalancing power and regaining power are also discussed. Data also include references to equality in health-care relationships and the levers and barriers to equity. The role that research can play in this power dynamic is more explicitly discussed. Examples include data where research brings about changed mindsets, surrenders power, or realigns control and power in relationships|
The other themes generally described standard information about the conduct of the research typically contained in an academic write-up of a peer-reviewed paper, but they did not reveal anything specific about the topic of service user involvement itself. For example, all accounts of Ethical Practice referred to standard procedures of applying and receiving ethical approval. There were no data about specific ethical considerations that had to be taken into account to support/enhance the service user involvement dimension, for example, the development of training or mentoring to enhance service users’ capacity for co-working and co-governance.
Our findings are reported under the headings of definition, enrolment, enactment and appraisal below.
The majority of papers were from the UK (n = 11). Four were from Ireland, three from the US, two from Australia and one each from Brazil, Canada, Finland, Germany, Sweden and The Netherlands.
Only six papers included a definition of service user involvement.[33-38
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