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Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e. usual NHS rehabilitation) is more clinically and cost-effective for supporting post-stroke RTW, than UC alone.Methods: Seven hundred sixty stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants' homes or workplaces, and outpatient/inpatient therapy settings, via telephone, email, or SMS text message. Outcome data will be collected via self-report questionnaires administered by post or online at 3, 6, and 12 months follow-up. The primary outcome will be self-reported RTW and job retention at 12 months (minimum 2 h/week). Secondary outcomes will include mood, function, participation, health-related quality of life, confidence, intervention compliance, health and social care resource use, and mortality. An embedded economic evaluation will estimate cost-effectiveness and cost-utility analyses from National Health Service (NHS) and Personal Social Services (PSS) perspectives. An embedded process evaluation will employ a mixed methods approach to explore ESSVR implementation, contextual factors linked to outcome variation, and factors affecting NHS roll-out.Discussion: This article describes the protocol for a multi-centre RCT evaluating the clinical- and cost-effectiveness of an early vocational rehabilitation intervention aimed at supporting adults to return to work following a stroke. Evidence favouring the ESSVR intervention would support its roll-out in NHS settings.Trial Registration: ISRCTN, ISRCTN12464275 . Registered on 26 February 2018. [ABSTRACT FROM AUTHOR]

The UK National Health Service (NHS) is changing. Consecutive UK industrial strategies have supported the shift from an NHS that provides free‐at‐point‐of‐delivery healthcare to one that also facilitates research. Said to promote healthcare's triple aim of 'better health, better healthcare, and lower cost' (Wachter, 2016, 3), the digitisation of patient records is a core part in opening routine aspects of the health system to potential research. In this paper, we thematically analyse 11 policy documents and ask, how does the NHS discuss its decision to digitise patient records and what are the implications of such practices on the citizen? We document how (1) digitisation is presented as a collective endeavour for patients and NHS professionals, offering new possibilities for patients to participate in their own health and that of the population through research and, (2) digitisation contributes to the building of an efficient health system. Through this analysis we reflect on how discussions of digitisation present uncritically the potential of Electronic Health Records and big data analytics to improve care and generate wealth through research, and reconfigure patienthood, by placing research participation as a routine part of accessing NHS healthcare. [ABSTRACT FROM AUTHOR]

The National Institute for Health Research (NIHR) aims to improve national 'health and wealth' by providing infrastructural support to enable clinical research in National Health Service settings in England and Wales. Cognisant of the consequences of studies' failure to achieve required numbers of participants, it also actively campaigns to promote patient awareness of research, and willingness to participate in trials. In this paper, we analyse recent NIHR campaigns and policies designed to encourage patients to participate in clinical research to interrogate how they are implicated in the national bioeconomy. In doing so we expand the notion of 'clinical labour' to include the work of patient recruitment and highlight an emergent obligation on patients to contribute to research processes. Whereas once patient knowledge and experience may have been devalued, here we draw on the concept of 'assetisation' (Birch 2012) to explore the emergent relationship between healthcare system and patient as research participant. We consider how patients' contribution goes beyond the provision of standardised objects of valuation so that patients themselves may be perceived as assets to, not only recipients of, the national healthcare system. [ABSTRACT FROM AUTHOR]

Whether New Public Management (NPM) ideas and practices have remained resilient or are now in decline remains a topic of contention. We investigate the case of a national system, introduced in 2006, for performance managing medical research in the United Kingdom's National Health System (NHS). We argue that the system conforms to traditional NPM, providing empirical evidence of its late adoption and resilience. We highlight potential conflicts in the adoption of NPM in this context and demonstrate for the first time the potential for this NPM-style system to produce unintended and unwanted consequences in the context of medical research. [ABSTRACT FROM AUTHOR]

Abstract: Background: Patient and public involvement is required where changes to care provided by the UK National Health Service are proposed. Yet involvement is characterized by ambiguity about its rationales, methods and impact. Aims: To understand how patients and carers were involved in major system changes (MSCs) to the delivery of acute stroke care in 2 English cities, and what kinds of effects involvement was thought to produce. Methods: Analysis of documents from both MSC projects, and retrospective in‐depth interviews with 45 purposively selected individuals (providers, commissioners, third‐sector employees) involved in the MSC. Results: Involvement was enacted through consultation exercises; lay membership of governance structures; and elicitation of patient perspectives. Interviewees’ views of involvement in these MSCs varied, reflecting different views of involvement per se, and of implicit quality criteria. The value of involvement lay not in its contribution to acute service redesign but in its facilitation of the changes developed by professionals. We propose 3 conceptual categories—agitation management, verification and substantiation—to identify types of process through which involvement was seen to facilitate system change. Discussion: Involvement was seen to have strategic and intrinsic value. Its strategic value lay in facilitating the implementation of a model of care that aimed to deliver evidence‐based care to all; its intrinsic value was in the idea of citizen participation in change processes as an end in its own right. The concept of value, rather than impact, may provide greater traction in analyses of contemporary involvement practices. [ABSTRACT FROM AUTHOR]

This paper examines a central image in UK academic clinical research – the patient as altruistic research subject – by means of an interpretive review of social science, bioethical and bioscience research and development policy literatures. The review examines this image as it is indicted in discussions about the nature of clinical science; is consolidated in the ethical regulation of this science; and is articulated in recent bioscience research and development government initiatives. Drawing on Strathern's notion of the virtual (public-sector) subject, the review identifies the anticipation of NHS patients as alternatively ‘available’ or ‘entitled’ to the expanding translational medicine industry. [ABSTRACT FROM AUTHOR]

Background: Significant changes in provision of clinical care within the English National Health Service (NHS) have been discussed in recent years, with proposals to concentrate specialist services in fewer centres. Stroke is a major public health issue, accounting for over 10% of deaths in England and Wales, and much disability among survivors. Variations have been highlighted in stroke care, with many patients not receiving evidence-based care. To address these concerns, stroke services in London and Greater Manchester were reorganised, although different models were implemented. This study will analyse processes involved in making significant changes to stroke care services over a short time period, and the factors influencing these processes. We will examine whether the changes have delivered improvements in quality of care and patient outcomes; and, in light of this, whether the significant extra financial investment represented good value for money. Methods/design: This study brings together quantitative data on 'what works and at what cost?' with qualitative data on 'understanding implementation and sustainability' to understand major system change in two large conurbations in England. Data on processes of care and their outcomes (e.g. morbidity, mortality, and cost) will be analysed to evidence services' performance before and after reconfiguration. The evaluation draws on theories related to the dissemination and sustainability of innovations and the 'social matrix' underlying processes of innovation. We will conduct a series of case studies based on stakeholder interviews and documentary analysis. These will identify drivers for change, how the reconfigurations were governed, developed, and implemented, and how they influenced service quality. Discussion: The research faces challenges due to: the different timings of the reconfigurations; the retrospective nature of the evaluation; and the current organisational turbulence in the English NHS. However, these issues reflect the realities of major systems change and its evaluation. The methods applied in the study have been selected to account for and learn from these complexities, and will provide useful lessons for future reconfigurations, both in stroke care and other specialties. [ABSTRACT FROM AUTHOR]

Objectives To understand how the policy of user involvement is interpreted in health service organisations and to identify factors that influence how user involvement is put into practice. Design Ethnographic study using participant observation, interviews, and collection of documentary evidence. Setting A multiagency modernisation programme to improve stroke services in two London boroughs. Participants Service users, National Health Service managers, and clinicians. Results User involvement in the programme was initiated and led by professionals. Professionals determined the areas of service improvement service users could participate in. A wide range of activities were considered "user involvement," from patient satisfaction surveys to service users delivering peer support. Involvement tended to be most active in the least technical areas and areas with least input from clinicians. Factors that might explain this included organisational structure, the vagueness of the concept of user involvement, the value attributed to service users' experiential knowledge, and variations in professional and service user understandings of and commitment to involvement. The gains of involvement were harder to identify in terms of impact on services. More evident were the personal gains for those involved: satisfaction of feeling listened to by professionals, social opportunities of meeting others in a similar situation, and increased knowledge about stroke and services available. Conclusions User involvement may not automatically lead to improved service quality. Healthcare professionals and service users understand and practise user involvement in different ways according to individual ideologies, circumstances, and needs. Given the resource implications of undertaking user involvement in service development there is a need for critical debate on the purpose of such involvement as well as better evidence of the benefits claimed for it. [ABSTRACT FROM AUTHOR]

In this article, the authors argue that the process for getting research ethics and governance approval in Great Britain remains affected by delay and arbitrary decisions. The authors describe their experience of using the Great Britain National Institute of Health Research Coordinated System for gaining National Health Service (NHS) Permission (NIHR CSP) to get research governance approval. They explain the delays that they have encountered during the process. They argue that although NIHR CSP slightly improved the process of getting research ethics and governance approval, problems still exist at the local level.