The policy and politics of healthcare corporatisation: The case of the English NHS.

RATIONALE: Few accounts of healthcare corporatisation examine the effects of the 2008 financial crisis. New Politics of the Welfare State (NPWS) theories recognise the relevance of crises but give more attention to programmatic than systemic (structural) retrenchment, and little to healthcare corporatisation. OBJECTIVE: To examine what changes the 2008 financial crisis produced in the pattern of healthcare corporatisation, and the implications for NPWS theories. METHODS: Using administrative data from the English NHS during 1995-2019 we formulated a multi-dimensional index of corporatisation, tested its validity, and used it to analyse longitudinally how the financial crisis affected the balance between the responsibilization of management and re-commodification (introduction of market-like practices) in provider corporatisation. RESULTS: The financial crisis influenced NHS corporatisation through the fiscal austerity with which governments responded. The re-commodification of NHS providers stalled but not the responsibilization of NHS managers. CONCLUSIONS: The corporatisation of NHS providers faltered after the financial crisis. These findings corroborate parts of NPWS theory but also reveal scope for further elaborating its accounts of systemic retrenchment in health systems.

Longitudinal realist evaluation of the Dementia PersonAlised Care Team (D-PACT) intervention: protocol.

BACKGROUND: Different dementia support roles exist but evidence is lacking on which aspects are best, for whom, and in what circumstances, and on their associated costs and benefits. Phase 1 of the Dementia PersonAlised Care Team programme (D-PACT) developed a post-diagnostic primary care-based intervention for people with dementia and their carers and assessed the feasibility of a trial. AIM: Phase 2 of the programme aims to 1) refine the programme theory on how, when, and for whom the intervention works; and 2) evaluate its value and impact. DESIGN & SETTING: A realist longitudinal mixed-methods evaluation will be conducted in urban, rural, and coastal areas across South West and North West England where low-income or ethnic minority populations (for example, South Asian) are represented. Design was informed by patient, public, and professional stakeholder input and phase 1 findings. METHOD: High-volume qualitative and quantitative data will be collected longitudinally from people with dementia, carers, and practitioners. Analyses will comprise the following: 1) realist longitudinal case studies; 2) conversation analysis of recorded interactions; 3) statistical analyses of outcome and experience questionnaires; 4a) health economic analysis examining costs of delivery; and 4b) realist economic analysis of high-cost events and 'near misses'. All findings will be synthesised using a joint display table, evidence appraisal tool, triangulation, and stakeholder co-analysis. CONCLUSION: The realist evaluation will describe how, why, and for whom the intervention does or does not lead to change over time. It will also demonstrate how a non-randomised design can be more appropriate for complex interventions with similar questions or populations.

Managerial workarounds in three European DRG systems.

PURPOSE: Attempts to transform health systems have in many countries involved starting to pay healthcare providers through a DRG system, but that has involved managerial workarounds. Managerial workarounds have seldom been analysed. This paper does so by extending and modifying existing knowledge of the causes and character of clinical and IT workarounds, to produce a conceptualisation of the managerial workaround. It further develops and revises this conceptualisation by comparing the practical management, at both provider and purchaser levels, of hospital DRG payment systems in England, Germany and Italy. DESIGN/METHODOLOGY/APPROACH: We make a qualitative test of our initial assumptions about the antecedents, character and consequences of managerial workarounds by comparing them with a systematic comparison of case studies of the DRG hospital payment systems in England, Germany and Italy. The data collection through key informant interviews (N = 154), analysis of policy documents (N = 111) and an action learning set, began in 2010-12, with additional data collection from key informants and administrative documents continuing in 2018-19 to supplement and update our findings. FINDINGS: Managers in all three countries developed very similar workarounds to contain healthcare costs to payers. To weaken DRG incentives to increase hospital activity, managers agreed to lower DRG payments for episodes of care above an agreed case-load 'ceiling' and reduced payments by less than the full DRG amounts when activity fell below an agreed 'floor' volume. RESEARCH LIMITATIONS/IMPLICATIONS: Empirically this study is limited to three OECD health systems, but since our findings come from both Bismarckian (social-insurance) and Beveridge (tax-financed) systems, they are likely to be more widely applicable. In many countries, DRGs coexist with non-DRG or pre-DRG systems, so these findings may also reflect a specific, perhaps transient, stage in DRG-system development. Probably there are also other kinds of managerial workaround, yet to be researched. Doing so would doubtlessly refine and nuance the conceptualisation of the 'managerial workaround' still further. PRACTICAL IMPLICATIONS: In the case of DRGs, the managerial workarounds were instances of 'constructive deviance' which enabled payers to reduce the adverse financial consequences, for them, arising from DRG incentives. The understanding of apparent failures or part-failures to transform a health system can be made more nuanced, balanced and diagnostic by using the concept of the 'managerial workaround'. SOCIAL IMPLICATIONS: Managerial workarounds also appear outside the health sector, so the present analysis of managerial workarounds may also have application to understanding attempts to transform such sectors as education, social care and environmental protection. ORIGINALITY/VALUE: So far as we are aware, no other study presents and tests the concept of a 'managerial workaround'. Pervasive, non-trivial managerial workarounds may be symptoms of mismatched policy objectives, or that existing health system structures cannot realise current policy objectives; but the workarounds themselves may also contain solutions to these problems.

A qualitative study of diverse providers' behaviour in response to commissioners, patients and innovators in England: research protocol.

INTRODUCTION: The variety of organisations providing National Health Service (NHS)-funded services in England is growing. Besides NHS hospitals and general practitioners (GPs), they include corporations, social enterprises, voluntary organisations and others. The degree to which these organisational types vary, however, in the ways they manage and provide services and in the outcomes for service quality, patient experience and innovation, remains unclear. This research will help those who commission NHS services select among the different types of organisation for different tasks. RESEARCH QUESTIONS: The main research questions are how organisationally diverse NHS-funded service providers vary in their responsiveness to patient choice, NHS commissioning and policy changes; and their patterns of innovation. We aim to assess the implications for NHS commissioning and managerial practice which follow from these differences. METHODS AND ANALYSIS: Systematic qualitative comparison across a purposive sample (c.12) of providers selected for maximum variety of organisational type, with qualitative studies of patient experience and choice (in the same sites). We focus is on NHS services heavily used by older people at high risk of hospital admission: community health services; out-of-hours primary care; and secondary care (planned orthopaedics or ophthalmology). The expected outputs will be evidence-based schemas showing how patterns of service development and delivery typically vary between different organisational types of provider. ETHICS, BENEFITS AND DISSEMINATION: We will ensure informants' organisational and individual anonymity when dealing with high profile case studies and a competitive health economy. The frail elderly is a key demographic sector with significant policy and financial implications. For NHS commissioners, patients, doctors and other stakeholders, the main outcome will be better knowledge about the relative merits of different kinds of healthcare provider. Dissemination will make use of strategies suggested by patient and public involvement, as well as DH and service-specific outlets.

Interaction between non-executive and executive directors in English National Health Service trust boards: an observational study.

BACKGROUND: National Health Service (NHS) trusts, which provide the majority of hospital and community health services to the English NHS, are increasingly adopting a 'public firm' model with a board consisting of executive directors who are trust employees and external non-executives chosen for their experience in a range of areas such as finance, health care and management. In this paper we compare the non-executive directors' roles and interests in, and contributions to, NHS trust boards' governance activities with those of executive directors; and examine non-executive directors' approach to their role in board meetings. METHODS: Non-participant observations of three successive trust board meetings in eight NHS trusts (primary care trusts, foundation trusts and self-governing (non-foundation) trusts) in England in 2008-9. The observational data were analysed inductively to yield categories of behaviour reflecting the perlocutionary types of intervention which non-executive directors made in trust meetings. RESULTS: The observational data revealed six main perlocutionary types of questioning tactic used by non-executive directors to executive directors: supportive; lesson-seeking; diagnostic; options assessment; strategy seeking; and requesting further work. Non-executive board members' behaviours in holding the executive team to account at board meetings were variable. Non-executive directors were likely to contribute to finance-related discussions which suggests that they did see financial challenge as a key component of their role. CONCLUSIONS: The pattern of behaviours was more indicative of an active, strategic approach to governance than of passive monitoring or 'rubber-stamping'. Nevertheless, additional means of maintaining public accountability of NHS trusts may also be required.

Risks, dangers and competing clinical decisions on venous thromboembolism prophylaxis in hospital care.

Drawing on wider sociologies of risk, this article examines the complexity of clinical risks and their management, focusing on risk management systems, expert decision-making and safety standards in health care. At the time of this study preventing venous thromboembolism (VTE) among in-patients was one of the top priorities for hospital safety in the English National Health Service (NHS). An analysis of 50 interviews examining hospital professionals' perceptions about VTE risks and prophylaxis illuminates how National Institute for Health and Clinical Excellence (NICE) guidelines influenced clinical decision-making in four hospitals in one NHS region. We examine four themes: the identification of new risks, the institutionalisation and management of risk, the relationship between risk and danger and the tensions between risk management systems and expert decision-making. The implementation of NICE guidelines for VTE prevention extended managerial control over risk management but some irreducible clinical dangers remained that were beyond the scope of the new VTE risk management systems. Linking sociologies of risk with the realities of hospital risk management reveals the capacity of these theories to illuminate both the possibilities and the limits of managerialism in health care.

Has incentive payment improved venous thrombo-embolism risk assessment and treatment of hospital in-patients?

This paper focuses on financial incentives rewarding successful implementation of guidelines in the UK National Health Service (NHS). In particular, it assesses the implementation of National Institute for Health and Clinical Excellence (NICE) venous thrombo-embolism (VTE) guidance in 2010 on the risk assessment and secondary prevention of VTE in hospital in-patients and the financial incentives driving successful implementation introduced by the Commissioning for Quality and Innovation for Payment Framework (CQUIN) for 2010-2011. We systematically compared the implementation of evidence-based national guidance on VTE prevention across two specialities (general medicine and orthopaedics) in four hospital sites in the greater South West of England by auditing and evaluating VTE prevention activity for 2009 (i.e. before the 2010 NICE guideline) and late 2010 (almost a year after the guideline was published). Analysis of VTE prevention activity reported in 816 randomly selected orthopaedic and general medical in-patient medical records was complemented by a qualitative study into the practical responses to revised national guidance. This paper's contribution to knowledge is to suggest that by financially rewarding the implementation of national guidance on VTE prevention, paradoxes and contradictions have become apparent between the 'payment by volume system' of Healthcare Resource Groups and the 'payment by results' system of CQUIN.

Plural provision of primary medical care in England, 2002-2012.

OBJECTIVES: Health care reforms often include provider diversification, including privatization, to increase competition and thereby health care quality and efficiency. Donabedian's organizational theory implies that the consequences will vary according to the providers' ownership. The aim was to examine how far that theory applies to changes in English NHS primary medical care (general practice) since 1998, and the consequences for patterns of service provision. METHODS: Framework analysis whose categories and structure reflected Donabedian's theory and its implications, populated with data from a systematic review, administrative sources and press rapportage. RESULTS: Two patterns of provider diversification occurred: 'native' diversification among existing providers and plural provision as providers with different types of ownership were introduced. Native diversification occurred through: extensive recruitment of salaried GPs; extending the range of services provided by general practices; introducing limited liability partnerships; establishing GPs with special clinical interests; and introducing a wider range of services for GPs to refer to. All of these had little apparent effect on competition between general practices. Plural provision involved: increased primary care provision by corporations; introducing GP-owned firms; establishing social enterprises (initially mostly out-of-hours cooperatives); and Primary Care Trusts taking over general practices. Plural provision was on a smaller scale than native diversification and appeared to go into reverse in 2011. CONCLUSIONS: Although the available data confirm the implications of Donabedian's theory, there are exceptions. Native diversification and plural provision policies differ in their implications for service development.

How managed a market? Modes of commissioning in England and Germany.

BACKGROUND: In quasi-markets governance over healthcare providers is mediated by commissioners. Different commissioners apply different combinations of six methods of control ('media of power') for exercising governance: managerial performance, negotiation, discursive control, incentives, competition and juridical control. This paper compares how English and German healthcare commissioners do so. METHODS: Systematic comparison of observational national-level case studies in terms of six media of power, using data from multiple sources. RESULTS: The comparison exposes and contrasts two basic generic modes of commissioning: 1. Surrogate planning (English NHS), in which a negotiated order involving micro-commissioning, provider competition, financial incentives and penalties are the dominant media of commissioner power over providers. 2. Case-mix commissioning (Germany), in which managerial performance, an 'episode based' negotiated order and juridical controls appear the dominant media of commissioner power. CONCLUSIONS: Governments do not necessarily maximise commissioners' power over providers by implementing as many media of power as possible because these media interact, some complementing and others inhibiting each other. In particular, patient choice of provider inhibits commissioners' use of provider competition as a means of control.

The implementation of NICE guidance on venous thromboembolism risk assessment and prophylaxis: a before-after observational study to assess the impact on patient safety across four hospitals in England.

BACKGROUND: Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalised patients. VTE prevention has been identified as a major health need internationally to improve patient safety. A National Institute for Health and Clinical Excellence (NICE) guideline was issued in February 2010. Its key priorities were to assess patients for risk of VTE on admission to hospital, assess patients for bleeding risk and evaluate the risks and benefits of prescribing VTE prophylaxis. The aim of this study was to evaluate the implementation of NICE guidance and its impact on patient safety. METHODS: A before-after observational design was used to investigate changes in VTE risk assessment documentation and inappropriate prescribing of prophylaxis between the year prior to (2009) and the year following (2010) the implementation of NICE guidance, using data from a 3-week period during each year. A total of 408 patients were sampled in each year across four hospitals in the NHS South region. RESULTS: Implementation strategies such as audit, education and training were used. The percentage of patients for whom a VTE risk assessment was documented increased from 51.5% (210/408) in 2009 to 79.2% (323/408) in 2010; difference 27.7% (95% CI: 21.4% to 33.9%; p < 0.001). There was little evidence of change in the percentage who were prescribed prophylaxis amongst patients without a risk assessment (71.7% (142/198) in 2009 and 68.2% (58/85) in 2010; difference -3.5% (95% CI: -15.2% to 8.2%; p =0.56) nor the percentage who were prescribed low molecular weight heparin amongst patients with a contraindication (14% (4/28) in 2009 and 15% (6/41) in 2010; RD = 0.3% (95% CI: -16.5% to 17.2%; p =0.97). CONCLUSIONS: The documentation of risk assessment improved following the implementation of NICE guidance; it is questionable, however, whether this led to improved patient safety with respect to prescribing appropriate prophylaxis.

The practice of commissioning healthcare from a private provider: learning from an in-depth case study.

BACKGROUND: The direction of health service policy in England is for more diversification in the design, commissioning and provision of health care services. The case study which is the subject of this paper was selected specifically because of the partnering with a private sector organisation to manage whole system redesign of primary care and to support the commissioning of services for people with long term conditions at risk of unplanned hospital admissions and associated service provision activities. The case study forms part of a larger Department of Health funded project on the practice of commissioning which aims to find the best means of achieving a balance between monitoring and control on the one hand, and flexibility and innovation on the other, and to find out what modes of commissioning are most effective in different circumstances and for different services. METHODS: A single case study method was adopted to explore multiple perspectives of the complexities and uniqueness of a public-private partnership referred to as the "Livewell project". 10 single depth interviews were carried out with key informants across the GP practices, the PCT and the private provider involved in the initiative. RESULTS: The main themes arising from single depth interviews with the case study participants include a particular understanding about the concept of commissioning in the context of primary care, ambitions for primary care redesign, the importance of key roles and strong relationships, issues around the adoption and spread of innovation, and the impact of the current changes to commissioning arrangements. The findings identified a close and high trust relationship between GPs (the commissioners) and the private commissioning support and provider firm. The antecedents to the contract for the project being signed indicated the importance of leveraging external contacts and influence (resource dependency theory). CONCLUSIONS: The study has surfaced issues around innovation adoption in the healthcare context. The case identifies 'negotiated order', managerial performance of providers and disciplinary control as three media of power used in combination by commissioners. The case lends support for stewardship and resource dependency governance theories as explanations of the underpinning conditions for effective commissioning in certain circumstances within a quasi marketised healthcare system.

Network resilience in the face of health system reform.

Many health systems now use networks as governance structures. Network 'macroculture' is the complex of artefacts, espoused values and unarticulated assumptions through which network members coordinate network activities. Knowledge of how network macroculture during 2006-2008 develops is therefore of value for understanding how health networks operate, how health system reforms affect them, and how networks function (and can be used) as governance structures. To examine how quasi-market reforms impact upon health networks' macrocultures we systematically compared longitudinal case studies of these impacts across two care networks, a programme network and a user-experience network in the English NHS. We conducted interviews with key informants, focus groups, non-participant observations of meetings and analyses of key documents. We found that in these networks, artefacts adapted to health system reform faster than espoused values did, and the latter adapted faster than basic underlying assumptions. These findings contribute to knowledge by providing empirical support for theories which hold that changes in networks' core practical activity are what stimulate changes in other aspects of network macroculture. The most powerful way of using network macroculture to manage the formation and operation of health networks therefore appears to be by focusing managerial activity on the ways in which networks produce their core artefacts.

The clinical content of NHS trust board meetings: an initial exploration.

OBJECTIVES: To differentiate between English NHS trust board meetings according to the percentage of clinical content and to explore which characteristics of board meetings might explain this. METHODS: Definition of scoring system for clinical content. Scoring of minutes for a random sample of 60 trusts. Qualitative analysis of a sub-sample, generated hypotheses about factors leading to higher percentage of clinical items was undertaken; testing of hypotheses in a longitudinal sample of minutes from 24 trusts over 1 year. RESULTS: Clinical content varied from 2% to 30%. Boards with a more clinical focus tended to link other issues including finance to clinical issues; have non-executive directors able to question board executives openly; make less use of acronyms in minutes; had more liaison with social services; and accepted questions from the public. CONCLUSIONS: Counting items in board minutes has prima facie validity as a means of defining how clinically focussed board meetings are, although more research is required to refine the method. The present method of analysing board minutes may provide one way of assessing board culture. IMPLICATIONS FOR NURSING MANAGEMENT: Directors of nursing can help focus trust board meetings on clinical matters. Further research is required to determine whether greater clinical content in trust board meetings has impacts on clinical practice or organizational performance.

Beyond the limits of clinical governance? The case of mental health in English primary care.

BACKGROUND: Little research attention has been given to attempts to implement organisational initiatives to improve quality of care for mental health care, where there is a high level of indeterminacy and clinical judgements are often contestable. This paper explores recent efforts made at an organisational level in England to improve the quality of primary care for people with mental health problems through the new institutional processes of 'clinical governance'. METHODS: Framework analysis, based on the Normalisation Process Model (NPM), of attempts over a five year period to develop clinical governance for primary mental health services in Primary Care Trusts (PCTs). The data come from a longitudinal qualitative multiple case-study approach in a purposive sample of 12 PCTs, chosen to reflect a maximum variety of organisational contexts for mental health care provision. RESULTS: The constant change within the English NHS provided a difficult context in which to attempt to implement 'clinical governance' or, indeed, to reconstruct primary mental health care. In the absence of clear evidence or direct guidance about what 'primary mental health care' should be, and a lack of actors with the power or skills to set about realising it, the actors in 'clinical governance' had little shared knowledge or understanding of their role in improving the quality of mental health care. There was a lack of ownership of 'mental health' as an integral, normalised part of primary care. CONCLUSION: Despite some achievements in regard to monitoring and standardisation of prescribing practice, mental health care in primary care seems to have so far largely eluded the gaze of 'clinical governance'. Clinical governance in English primary mental health care has not yet become normalised. We make some policy recommendations which we consider would assist in the process normalisation and suggest other contexts to which our findings might apply.

Exit, voice, governance and user-responsiveness: the case of English primary care trusts.

Hirschman contrasts exit and voice as 'recuperation' mechanisms for making organisations responsive to users. However, the emergence of health-care quasi-markets and of network governance structures since Hirschman necessitate revising his theory, for they complicate the relationships between governance structures and recuperation mechanisms. Using a case study of nine primary care trusts (PCTs), this paper analyses the recuperation mechanisms, governance structures and relations between them in primary care in England. User voice can be exercised through dedicated networks besides hierarchies. As well as the 'user exit' described by Hirschman, two new 'exit' mechanisms now exist in quasi-markets. Commissioner exit occurs when a third-party payer stops using a given provider. Professional proxy exit occurs when a general practitioner (GP) fund-holder (or analogous budget-holder) behaves similarly. Neither exit mechanism requires the existence of mechanisms for user exit from healthcare purchasers, provided strong voice mechanisms exist instead to make commissioners responsive to users' demands. Establishing such voice mechanisms is not straightforward, however, as the experience of English PCTs illustrates.

A survey and audit of the first 'Guides to Local Health Services' produced by Primary Care Trusts in England.

BACKGROUND: Providing more information for the public about the range and quality of health services is an important part of improving accountability, quality and public responsiveness. Most sources of information to date have failed to address the information needs of people about their local services. The launch in England in 2002 of a new publication, Guides to Local Health Services, was designed to address this deficiency. We conducted an audit of the first Guides, and surveyed those responsible for their production, in order to examine the Guides' development, content, presentation and dissemination, and to critique the purpose of the initiative. METHODS: A semi-structured questionnaire survey of those responsible for producing the Guides, and an audit of the Guides produced by Primary Care Trusts (PCTs). RESULTS: Most PCTs complied with central guidance about structure and content, but in meeting multiple requirements the Guides lost their clarity of purpose. The content was dominated by information relating to financial and strategic accountability. In producing the Guides, external consultation was limited, particularly with the public but also with local partnership providers of health and social care. The main issues were the lack of a clear focus for Guide information, the level of central direction, the short production lead times, difficulties with distribution, and the many competing demands being made on PCT resources. CONCLUSIONS: Guide content should be clearly focused on information that the public wants. Greater responsibility should be devolved to front line PCT staff to determine content in consultation with local users.

Governance in gridlock in the Russian health system; the case of Sverdlovsk oblast.

Epidemiological, demographic and environmental crises, transition to a new political regime and exceptionally severe economic crises were powerful stimuli to health sector reform in Russia. The Russian Federation responded by introducing medical insurance whilst decentralising public administration. Yet despite intense contextual pressures to do so and a new policy climate, Russian hospitals found it difficult to reprofile services and reallocate their resources. A case study analysing governance structures in Sverdlovsk oblast reveals that medical insurance created incentives to reduce costs by reducing bed-days, but if hospitals did so they would lose money under the formulae through which decentralised local government still allocated around three-quarters of hospital income. If instead hospitals tried to increase budgetary income by increasing numbers of bed-days, the insurance system would penalise them. This specific form of policy mess can be called 'governance in gridlock'. The juxtaposition of two overlapping but incompatible sets of governance structures practically immobilised official hospital management systems. It is as one-sided to blame residues of the Soviet system for this gridlock as it is to blame the medical insurance system. Gridlock resulted from the interaction of the two, a problem to which all health system reform is potentially vulnerable.

A qualitative study of the cultural changes in primary care organisations needed to implement clinical governance.

BACKGROUND: It is commony claimed that changing the culture of health organisations is a fundamental prerequisite for improving the National Health Service (NHS). Little is currently known about the nature or importance of culture and cultural change in primary care groups and trusts (PCG/Ts) or their constituent general practices. AIMS: To investigate the importance of culture and cultural change for the implementation of clinical governance in general practice by PCG/Ts, to identify perceived desirable and undesirable cultural attributes of general practice, and to describe potential facilitators and barriers to changing culture. DESIGN: Qualitative: case studies using data derived from semi-structured interviews and review of documentary evidence. SETTING: Fifty senior non-clinical and clinical managers from 12 purposely sampled PCGs or trusts in England. RESULTS: Senior primary care managers regard culture and cultural change as fundamental aspects of clinical governance. The most important desirable cultural traits were the value placed on a commitment to public accountability by the practices, their willingness to work together and learn from each other, and the ability to be self-critical and learn from mistakes. The main barriers to cultural change were the high level of autonomy of practices and the perceived pressure to deliver rapid measurable changes in general practice. CONCLUSIONS: The culture of general practice is perceived to be an important component of health system reform and quality improvement. This study develops our understanding of a changing organisational culture in primary care; however, further work is required to determine whether culture is a useful practical lever for initiating or managing improvement.

User involvement in clinical governance.

OBJECTIVES: To investigate the involvement of users in clinical governance activities within Primary Care Groups (PCGs) and Trusts (PCTs). Drawing on policy and guidance published since 1997, the paper sets out a framework for how users are involved in this agenda, evaluates practice against this standard and suggests why current practice for user involvement in clinical governance is flawed and why this reflects a flaw in the policy design as much as its implementation. DESIGN: Qualitative data comprising semi-structured interviews, reviews of documentary evidence and relevant literature. SETTING: Twelve PCGs/PCTs in England purposively selected to provide variation in size, rurality and group or trust status. PARTICIPANTS: Key stakeholders including Lay Board members (n = 12), Chief Executives (CEs) (n = 12), Clinical Governance Leads (CG leads) (n = 14), Mental Health Leads (MH leads) (n = 9), Board Chairs (n = 2) and one Executive Committee Lead. RESULTS: Despite an acknowledgement of an organizational commitment to lay involvement, in practice very little has occurred. The role of lay Board members in setting priorities and implementing and monitoring clinical governance remains low. Beyond Board level, involvement of users, patients of GP practices and the general public is patchy and superficial. The PCGs/PCTs continue to rely heavily on Community Health Councils (CHCs) as a conduit or substitute for user involvement; although their abolition is planned, their role to be fulfilled by new organizations called Voices, which will have an expanded remit in addition to replacing CHCs. CONCLUSIONS: Clarity is required about the role of lay members in the committees and subcommittees of PCGs and PCTs. Involvement of the wider public should spring naturally from the questions under consideration, rather than be regarded as an end in itself.