User involvement in regulation: A qualitative study of service user involvement in Care Quality Commission inspections of health and social care providers in England

Abstract Background High profile failures of care in the NHS have raised concerns about regulatory systems for health‐care professionals and organizations. In response, the Care Quality Commission (CQC), the regulator of health and social care in England overhauled its regulatory regime. It moved to inspections which made much greater use of expert knowledge, data and views from a range of stakeholders, including service users. Objective We explore the role of service users and citizens in health and social care regulation, including how CQC involved people in inspecting and rating health and social care providers. Design We analyse CQC reports and documents, and 61 interviews with CQC staff and representatives of groups of service users and citizens and voluntary sector organizations to explore the place of service user voice in regulatory processes. Results Care Quality Commission invited comments and facilitated the sharing of existing service user experiences and engaged with representatives of groups of service users and voluntary sector organizations. CQC involved service users in their inspections as “experts by experience.” Information from service users informed both the inspection regime and individual inspections, but CQC was less focused on giving feedback to service users who contributed to these activities. Discussion and conclusions Service users can make an important contribution to regulation by sharing their experiences and having their voices heard, but their involvement was somewhat transactional, and largely on terms set by CQC. There may be scope for CQC to build more enduring relationships with service user groups and to engage them more effectively in the regulatory regime.


| INTRODUC TI ON
In recent years, there have been a series of high profile failures of care in the NHS in England, and subsequent public inquiries have raised serious concerns about how well systems to oversee, regulate and hold to account health-care professionals and organizations have worked. [1][2][3] In response to recommendations from the Francis inquiry report, 2 the Department of Health announced policy changes intended to ensure that poor care would be detected and acted upon. 4 The Care Quality Commission (CQC) overhauled the way it regulated and inspected health and social care providers, 5 moving to inspections which made much greater use of expert knowledge, data and views from a range of stakeholders, including service users. Performance was rated using a four-point scale (outstanding, good, requires improvement or inadequate) and detailed narrative reports about providers were published following each inspection. 6 During these reforms, public consultations 5,7 revealed shortcomings in CQC's public engagement strategy. In 2013, CQC sets an ambition to build better relationships with the public, to "promote greater public understanding and awareness of our work, improve our public information, improve how we listen to and act on people's views and experiences of care, and involve more people in our work" 6 p. 14. Furthermore, it said it would also inspect how service users, citizens and their representatives were engaged, and involved in improving services. 6 CQC does include service users or lay people as members of inspection teams, commonly termed "experts by experience." As carers, or previous or current users of services, experts by experience are considered better positioned to elicit experiences from those using the service under review. 8 The Francis inquiry also found that bodies responsible for patient, public and local scrutiny had been preoccupied with constitutional and procedural matters and consequently had failed to represent service user interests. 4 Government had already legislated in 2012 to establish Healthwatch as a national body and a network of local authority-commissioned services to listen to and share people's views of health and social care 9 and it undertook to ensure both national and local Healthwatch were centrally engaged in CQC's inspection and rating process. 4 Research has shown the importance of and potential for service user and citizen voice in regulatory activities, [10][11][12] where voice refers both to people commenting on care received and being involved in the planning and provision of services and regulation, through local and community networks. 13 Individual service user complaints are valuable to regulators and have previously highlighted failures in care, even if not always acted upon. 10 Involving service users can improve institutional reviews of providers and services, by bringing legitimacy and accountability to the decision-making process. 10,12 Regulators have been advised to capitalize on existing involvement activities and networks and to ensure any additional activities are tailored to regulatory goals. 10 However, the arrangements for service user voice in health-care regulation are not without criticism. Some question whether regulators really value patients as a source of information 10 and others argue that the quality of the information gathered during institutional review from service users and citizens is very dependent upon the skills of the inspection team. 14 The use of the term "expert by experience" has been challenged, as using a service or caring for someone might not necessarily qualify someone as an expert or as a lay assessor. 8,15 Additionally, professional hierarchies in inspection teams can make the integration of lay members difficult, affecting how well their voice is heard. 16 It has been suggested that service user involvement in inspection may largely serve to add credibility to inspection judgements rather than genuinely promote service user experience within the inspection process. 8 These developments should be set in the context of a substantial wider literature on service user voice in health and social care, which conceptualizes voice as both individually and collectively organized and heard. 17 Individual voice comes from service users being involved with or interacting with health-care professionals, as clients of health-care organizations and as citizens who are entitled to access NHS health-care services. Collective voice comes from groups of service users, care givers and citizens who, as lay stakeholders, provide representation on broader health issues faced by the segments of the population they represent. Individual voice, through lodging a complaint for example, can have a large impact at the micro level, improving care for those individuals but not necessarily leading to system level or policy changes. However, collective voice can lead to change at the system level which may have a wider and more enduring impact, for more people. 18 Arnstein's ladder of citizen participation 19 has been widely used by researchers, policy makers and practitioners in conceptualising user participation. Figure 1 depicts a number of levels of citizen participation, in three main categories-from "non-participation" through "tokenism" to "citizen power." Non-participation involves those with power attempting to educate or manipulate users but not really to involve them at all. What Arnstein describes as tokenism comprises efforts to inform users and consult them, but on terms framed or set by those in power, and in so doing to placate or reassure them. Citizens begin to have some influence, but those with power still have the final say, maintaining the status quo. At the top of the ladder, collective voice becomes "citizen power." Citizens' negotiate with the power holders, share responsibility for decision making and occupy key decision-making positions. For almost 50 years, this framework has been widely used to understand patient and public involvement in the planning and provision

K E Y W O R D S
Care Quality Commission, health care, inspection, regulation, social care, user involvement of health care. 20,21 Yet, it has received criticism for being implicitly normative, suggesting progression upward towards genuine participation is desirable. 22 Instead of focussing on the shift in power from one party to another, there is value in considering the impact service user involvement has at various levels as part of a wider system of participation. 23 The aim of this paper is to present an inductive analysis of the role of service users and citizens in health and social care regulation, the first such investigation of this topic. We use Arnstein's ladder of participation to frame our understanding of CQC's involvement of people in the inspection and rating of health and social care providers.

| ME THODOLOGY
This paper draws on data collected between 2016 and 2017 as part of an evaluation of the effects of the CQC's new inspection and rating system on provider performance in England. Specifically, we focus on the role of service user voice in the inspection and rating of health and social care providers.
Our qualitative fieldwork focused on four care sectors: acute care, mental health, adult social care and general practice. Members of the research team observed comprehensive inspections in each of these sectors to gain an understanding of the research context. 24 We also analysed selected CQC publications, policies, guidance and internal documents to understand whether and how user voice was incorporated into CQC's regulatory processes. The fieldwork took place in six geographic case study areas, loosely based on Clinical Commissioning Group (CCG) boundaries, and chosen to represent a variety of rural and urban contexts. In each area, at the time of our fieldwork there was a mix of organizations that had been inspected, with varying resulting ratings, and some which had not yet been inspected.
Interviewees were purposefully sampled according to their organization and job role. 25 Interviews were conducted either face to face or by telephone depending on interviewee availability and preference. We interviewed a total of 61 interviewees, including 52 people from the six case study areas (see Table 1). The interviewees For CQC staff, questions focused on how the process of inspection and rating was intended to drive improvements in the quality of care of provider services, including questions concerning the place and use of service user voice. We also probed for reflections on how this was working in practice, including any unintended impacts. For Healthwatch and service user group interviewees, questions focused on how information CQC published was used, if service users and groups were involved with CQC or local provider organizations as they prepared for inspection, as they were being inspected or after the inspection outcome. We also asked about the nature and quality We also interviewed eight CQC policy staff who were not area based, and one national representative of a PPG, making a total of 61 interviewees.

TA B L E 1 Interviewees by case study area
of the relationships between service user groups and CQC, and how inspection and rating impacted on service user experiences.
Informed consent was obtained for all interviews. The interviews were recorded, transcribed and coded by the research team in Dedoose, a qualitative software tool. 26 Two members of the research team coded the interviews using an inductive, data driven approach 27 allowing emerging themes to be identified. During analysis, ongoing discussion of themes and interpretation within the research team ensured analysis and interpretation was grounded in the interview data. 28

| FINDING S
In this section, we present the main themes which emerged from our document analysis and interviews with CQC staff and service user group representatives. Arnstein's ladder of participation contains three main levels: the rungs at the lower end are categorized as "nonparticipation," those in the middle are labelled "tokenism," and those at the higher end are designated "citizen power." We find that the involvement of people in CQC's inspection and rating regime falls largely within the middle rungs of the ladder, informing, consultation and placation. We would note that the terms lower, middle and higher are used to relate CQC's service user involvement activities to Arnstein's ladder, but we do not presume that higher levels are necessarily preferable.
First, we examine how CQC draws on existing sources of service user voice, by gathering available data from various stakeholders prior to an inspection. Second, we explore how CQC engages with individual service users around the time of an inspection, to gather data relevant to the areas to be inspected. Third, we describe how CQC involves some service users directly in the inspection process, through its "experts by experience" programme. Fourth, we examine how CQC engages with service user groups to consult and gather collective voice, often less directly linked to a specific inspection.
Finally, we explore how CQC provides information and feedback to service users after inspection, and the views of service users on the outcomes of inspections. From our interviews, we heard how an effort to publicize their ratings and reports in the media had resulted in an increased awareness among service users and the wider public of CQC's work.

| Gathering existing service user voice
Changing attitudes to reporting poor care were leading to an in-

| Consulting service users: seeking individual voice
In addition to gathering available information about service users' experiences from individuals and representatives of service user groups, we found from our document review and interviews with CQC staff that some specific engagement activities were organ- The information generated from these activities was used to inform the ongoing inspection.
Our interviews with representatives of service user and citizen groups highlighted some practical issues with these engagement activities. We were told that service users and citizens wanted to contribute but the events were often not well publicized and organized without enough advance notice for certain groups to attend, particularly those who might require assistance. Generally, there was a perception from interviewees that opportunities to engage were not sufficiently con- We heard differing perceptions of the listening events from interviewees. On the one hand, we were told they sometimes attracted those with a particular, often negative, experience to share, but we also heard that while that may be the case for some individuals, on the whole there were a range of experiences voiced at these events.

| Involving service users in inspection: experts by experience
Service users had some citizen power when they participated in We heard from a service user representative perspective that in-

| Speaking with local service user groups: seeking collective voice
In addition to gathering individual experiences, and facilitating en- We also found that CQC sought advice through some standing advisory panels (such as "eQuality Voices" for diversity and quality, Service User Reference Panel (SURP) for those detained under the Mental Health Act, "SpeakOut" for diverse and vulnerable communities). 30 These groups and networks served as a way to bring voices of smaller groups, into much larger networks. These networks raised awareness of and developed relationships between CQC and local groups and organizations across the country. The collective voice was then used by CQC to prioritize forthcoming inspections and informed the areas of focus for inspection teams. We heard that groups and organizations were exposed to a range of service user experiences in their work.
We do outreach sessions to specific groups of people  Multiple interviewees also told us they wanted to hear how their voice had been translated into the inspection process and how their input had resulted in change or action, rather than this being a "mysterious" process, as one interviewee put it.

| D ISCUSS I ON
Care Quality Commission has a large remit, tasked with regulating all health and social care providers in England, but limited resources.
To do this, it relies on information held by many stakeholders and system partners, including patients, service users and the public. to local communities and their concerns makes the regulatorregulatee relationship more complex, placing additional demands on regulatory staff, who need to adopt a more flexible approach that is socially and politically aware, in order to engage service users in a productive process. 32 Our study also adds to the literature which has highlighted ongoing difficulties in involvement of health and social care users in England, particularly at a collective level. 33 CQC has shown that progress can be made, but that institutionalising and sustaining change may be difficult. There may be a need to go beyond the middle levels of the ladder to work in partnership with service user groups in order to enable fundamental and lasting change.
Despite the strengths of our study, it was not without its limitations. We conducted 61 interviews which enabled us to comment on the role of service user voice within the inspections. We interviewed a range of CQC and service user and voluntary organization representatives across six case study areas and four health and social care sectors. Systematic variations between our case study sites were not a prominent feature of our data analysis and so are not specifically reported on in our findings, future research may seek to explore variations further. Our study did not explore CQC's public engagement work at a national level to support its thematic reviews such as the State of Care reports. 34 Interviewing the public, service users and experts by experience directly could provide more detailed understanding of how these engagement activities work in practice. Further study could focus on the role of experts by experience, to understand how local recruitment might work in practice.

| CON CLUS IONS
The encounters between CQC, individual and collective voices seemed to be somewhat transactional, organized directly to serve CQC functions and processes but not to build enduring relationships with local service user groups. There was a lack of transparency about how voice was incorporated into the inspection and rating process, and once people had shared their experiences with CQC, the engagement came to an end. Developing relationships that exist beyond an inspection and outside the inspection cycle would create opportunities for mutual and ongoing sharing of information, which could be used to help assess risk and build detailed profiles of providers so at the point of inspection, teams have more service user data to draw upon, and are better placed to engage in more focused and appropriate service user involvement during inspections.

ACK N OWLED G EM ENTS
The report is an output from independent research commissioned and funded by the NIHR Policy Research Programme (PR-R11-0914-12001 Provider ratings: the effects of the Care Quality Commission's new inspection and rating system on provider performance). The views expressed in the publication are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health, 'arms' length bodies or other government departments.

CO N FLI C T O F I NTE R E S T S
There are no conflict of interests.