Does the process of developing products for knowledge mobilisation from healthcare research influence their uptake? A comparative case study.

BACKGROUND: Getting knowledge from healthcare research into practice (knowledge mobilisation) remains a global challenge. One way in which researchers may attempt to do this is to develop products (such as toolkits, actionable tools, dashboards, guidance, audit tools, protocols and clinical decision aids) in addition to journal papers. Despite their increasing ubiquity, the development of such products remains under-explored in the academic literature. This study aimed to further this understanding by exploring the development of products from healthcare research and how the process of their development might influence their potential application. METHODS: This study compared the data generated from a prospective, longitudinal, comparative case study of four research projects which aimed to develop products from healthcare research. Qualitative methods included thematic analysis of data generated from semi-structured interviews (38), meeting observations (83 h) and project documents (300+). Cases were studied for an average of 11.5 months (range 8-19 months). RESULTS: Case comparison resulted in the identification of three main themes with the potential to affect the use of products in practice. First, aspects of the product, including the perceived need for the specific product being identified, the clarity of product aim and clarity and range of end-users. Second, aspects of development, whereby different types of stakeholder engagement appear to influence potential product application, which either needs to be 'meaningful', or delivered through the implicit understanding of users' needs by the developing team. The third, overarching theme, relates to the academic context in which products are developed, highlighting how the academic context perpetuates the development of products, which may not always be useful in practice. CONCLUSIONS: This study showed that aspects of products from healthcare research (need/aim/end-user) and aspects of their development (stakeholder engagement/implicit understanding of end-users) influence their potential application. It explored the motivation for product development and identifies the influence of the current academic context on product development. It shows that there is a tension between ideal 'systems approaches' to knowledge mobilisation and 'linear approaches', which appear to be more pervasive in practice currently. The development of fewer, high-quality products which fulfil the needs of specified end-users might act to counter the current cynicism felt by many stakeholders in regard to products from healthcare research.

Contributors are representative, as long as they agree: How confirmation logic overrides effort to achieve synthesis in applied health research.

INTRODUCTION: The paradox of representation in public involvement in research is well recognized, whereby public contributors are seen as either too naïve to meaningfully contribute or too knowledgeable to represent 'the average patient'. Given the underlying assumption that expertise undermines contributions made, more expert contributors who have significant experience in research can be a primary target of criticism. We conducted a secondary analysis of a case of expert involvement and a case of lived experience, to examine how representation was discussed in each. METHODS: We analysed a case of a Lived Experience Advisory Panel (LEAP) chosen for direct personal experience of a topic and a case of an expert Patient and Public Involvement (PPI) panel. Secondary analysis was of multiple qualitative data sources, including interviews with the LEAP contributors and researchers, Panel evaluation data and documentary analysis of researcher reports of Panel impacts. Analysis was undertaken collaboratively by the author team of contributors and researchers. RESULTS: Data both from interviews with researchers and reported observations by the Panel indicated that representation was a concern for researchers in both cases. Consistent with previous research, this challenge was deployed in response to contributors requesting changes to researcher plans. However, we also observed that when contributor input could be used to support research activity, it was described unequivocally as representative of 'the patient view'. We describe this as researchers holding a confirmation logic. By contrast, contributor accounts enacted a synthesis logic, which emphasized multiplicity of viewpoints and active dialogue. These logics are incompatible in practice, with the confirmation logic constraining the potential for the synthesis logic to be achieved. CONCLUSION: Researchers tend to enact a confirmation logic that seeks a monophonic patient voice to legitimize decisions. Contributors are therefore limited in their ability to realize a synthesis logic that would actively blend different types of knowledge. These different logics hold different implications regarding representation, with the synthesis logic emphasizing diversity and negotiation, as opposed to the current system in which 'being representative' is a quality attributed to contributors by researchers. PATIENT OR PUBLIC CONTRIBUTION: Patient contributors are study coauthors, partners in analysis and reporting.

Scale-up of ABC care bundle for intracerebral haemorrhage across two hyperacute stroke units in one region in England: a mixed methods evaluation of a quality improvement project.

BACKGROUND: Intracerebral haemorrhage (ICH) accounts for 10%-15% of strokes in the UK, but is responsible for half of all annual global stroke deaths. The ABC bundle for ICH was developed and implemented at Salford Royal Hospital, and was associated with a 44% reduction in 30-day case fatality. Implementation of the bundle was scaled out to the other hyperacute stroke units (HASUs) in the region from April 2017. A mixed methods evaluation was conducted alongside to investigate factors influencing implementation of the bundle across new settings, in order to provide lessons for future spread. METHODS: A harmonised quality improvement registry at each HASU captured consecutive patients with spontaneous ICH from October 2016 to March 2018 to capture process and outcome measures for preimplementation (October 2016 to March 2017) and implementation (April 2017 to March 2018) time periods. Statistical analyses were performed to determine differences in process measures and outcomes before and during implementation. Multiple qualitative methods (interviews, non-participant observation and project document analysis) captured how the bundle was implemented across the HASUs. RESULTS: HASU1 significantly reduced median anticoagulant reversal door-to-needle time from 132 min (IQR: 117-342) preimplementation to 76 min (64-113.5) after implementation and intensive blood pressure lowering door to target time from 345 min (204-866) preimplementation to 84 min (60-117) after implementation. No statistically significant improvements in process targets were observed at HASU2. No significant change was seen in 30-day mortality at either HASU. Qualitative evaluation identified the importance of facilitation during implementation and identified how contextual changes over time impacted on implementation. This identified the need for continued implementation support. CONCLUSION: The findings show how the ABC bundle can be successfully implemented into new settings and how challenges can impede implementation. Findings have been used to develop an implementation strategy to support future roll out of the bundle outside the region.

"Attending to History" in Major System Change in Healthcare in England: Specialist Cancer Surgery Service Reconfiguration.

BACKGROUND: The reconfiguration of specialist hospital services, with service provision concentrated in a reduced number of sites, is one example of major system change (MSC) for which there is evidence of improved patient outcomes. This paper explores the reconfiguration of specialist oesophago-gastric (OG) cancer surgery services in a large urban area of England (Greater Manchester, GM), with a focus on the role of history in this change process and how reconfiguration was achieved after previous failed attempts. METHODS: This study draws on qualitative research from a mixed-methods evaluation of the reconfiguration of specialist cancer surgery services in GM. Forty-six interviews with relevant stakeholders were carried out, along with ~160 hours of observations at meetings and the acquisition of ~300 pertinent documents. Thematic analysis using deductive and inductive approaches was undertaken, guided by a framework of 'simple rules' for MSC. RESULTS: Through an awareness of, and attention to, history, leaders developed a change process which took into account previous unsuccessful reconfiguration attempts, enabling them to reduce the impact of potentially challenging issues. Interviewees described attending to issues involving competition between provider sites, change leadership, engagement with stakeholders, and the need for a process of change resilient to challenge. CONCLUSION: Recognition of, and response to, history, using a range of perspectives, enabled this reconfiguration. Particularly important was the way in which history influenced and informed other aspects of the change process and the influence of stakeholder power. This study provides further learning about MSC and the need for a range of perspectives to enable understanding. It shows how learning from history can be used to enable successful change.

Impact and sustainability of centralising acute stroke services in English metropolitan areas: retrospective analysis of hospital episode statistics and stroke national audit data.

OBJECTIVES: To investigate whether further centralisation of acute stroke services in Greater Manchester in 2015 was associated with changes in outcomes and whether the effects of centralisation of acute stroke services in London in 2010 were sustained. DESIGN: Retrospective analyses of patient level data from the Hospital Episode Statistics (HES) database linked to mortality data from the Office for National Statistics, and the Sentinel Stroke National Audit Programme (SSNAP). SETTING: Acute stroke services in Greater Manchester and London, England. PARTICIPANTS: 509 182 stroke patients in HES living in urban areas admitted between January 2008 and March 2016; 218 120 stroke patients in SSNAP between April 2013 and March 2016. INTERVENTIONS: Hub and spoke models for acute stroke care. MAIN OUTCOME MEASURES: Mortality at 90 days after hospital admission; length of acute hospital stay; treatment in a hyperacute stroke unit; 19 evidence based clinical interventions. RESULTS: In Greater Manchester, borderline evidence suggested that risk adjusted mortality at 90 days declined overall; a significant decline in mortality was seen among patients treated at a hyperacute stroke unit (difference-in-differences -1.8% (95% confidence interval -3.4 to -0.2)), indicating 69 fewer deaths per year. A significant decline was seen in risk adjusted length of acute hospital stay overall (-1.5 (-2.5 to -0.4) days; P<0.01), indicating 6750 fewer bed days a year. The number of patients treated in a hyperacute stroke unit increased from 39% in 2010-12 to 86% in 2015/16. In London, the 90 day mortality rate was sustained (P>0.05), length of hospital stay declined (P<0.01), and more than 90% of patients were treated in a hyperacute stroke unit. Achievement of evidence based clinical interventions generally remained constant or improved in both areas. CONCLUSIONS: Centralised models of acute stroke care, in which all stroke patients receive hyperacute care, can reduce mortality and length of acute hospital stay and improve provision of evidence based clinical interventions. Effects can be sustained over time.

Pre-hospital stroke recognition in a UK centralised stroke system: a qualitative evaluation of current practice.

BACKGROUND: A significant number of patients conveyed via ambulance to hyper acute stroke units (HASU) with suspected stroke have other diagnoses. This may delay treatment for non-stroke patients and cause burden to stroke teams. The Greater Manchester (GM) Connected Health Cities (CHC) stroke project links historical North West Ambulance Service NHS Trust (NWAS) data with Salford Royal Hospital electronic data to study stroke pathway compliance and accuracy of paramedic diagnosis and aims to use these data to improve pre-hospital clinicians' accurate recognition of stroke through development of service improvement innovations. We report on supplementary qualitative work required to understand stroke recognition from the pre-hospital clinician's perspective. METHODS: Focus groups and semi-structured interviews were conducted with pre-hospital clinicians of various grades, working in the GM area of NWAS. Focus groups and interviews were audio recorded and transcribed verbatim. We used thematic analysis informed by normalisation process theory (NPT) to analyse the data. This theory helps us to understand how innovations are developed, implemented and sustained into healthcare practice. RESULTS: Sixteen pre-hospital clinicians took part in two focus groups, one dyad interview and five one-to-one interviews. Analysis identified that respondents were unaware of false positive stroke rates entering onto the stroke pathway. Pre-hospital clinicians receive limited feedback from jobs and this impedes their ability to learn from their experiences. Respondents reported difficulty in ruling out stroke in certain patient cohorts and difficulty in recognising differential diagnoses. They expressed a lack of confidence to rule out stroke in the pre-hospital setting. They also expressed greater concern for 'missed strokes'. CONCLUSION: The qualitative findings support the development of innovations to improve accurate recognition of stroke in the pre-hospital setting.An enhanced FAST tool, better relations with HASU clinicians, feedback and education on the stroke pathway and differential diagnoses were all considered useful to improve accurate stroke recognition.

Learning from the emergence of NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRCs): a systematic review of evaluations.

BACKGROUND: Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) were funded by NIHR in England in 2008 and 2014 as partnerships between universities and surrounding health service organisations, focused on improving the quality of healthcare through the conduct and application of applied health research. The aim of this review is to synthesise learning from evaluations of the CLAHRCs. METHODS: Fifteen databases including CINAHL, MEDLINE, EMBASE and PsycINFO were searched to identify any evaluations of CLAHRCs. Current and archived CLAHRC websites and the reference lists of retrieved articles were scanned to identify any additional evaluations. Searches were restricted to English language only. Any publications from evaluations of the CLAHRCs were eligible for inclusion if they fulfilled at least one of three pre-specified inclusion criteria. A narrative synthesis was undertaken. RESULTS: Twenty-six evaluations (reported in 37 papers) were deemed eligible for inclusion. Evaluations focused on describing and exploring the formative partnerships, vision, values, structures and processes of CLAHRCs; the nature and role of boundaries; the deployment of knowledge brokers and hybrid roles to support knowledge mobilisation; patient and public involvement; and capacity building. The relative lack of data about the early impact of CLAHRCs on health care provision or outcomes is notable. CONCLUSIONS: Much of the evaluative focus on CLAHRCs has been on how they have been organised and on the development of theory around their emergent properties. Evidence is lacking on the impact of CLAHRCs particularly in relation to the knowledge mobilisation processes and practices adopted. Further evaluation of CLAHRCs and other similar research and practice partnerships is warranted and should focus on which knowledge mobilisation approaches work where, how and why. TRIAL REGISTRATION: PROSPERO (Registration number: CRD42016042945 ).

Assessing improvement capability in healthcare organisations: a qualitative study of healthcare regulatory agencies in the UK.

OBJECTIVES: Healthcare regulatory agencies are increasingly concerned not just with assessing the current performance of the organisations they regulate, but with assessing their improvement capability to predict their future performance trajectory. This study examines how improvement capability is conceptualised and assessed by healthcare UK regulatory agencies. DESIGN: Qualitative analysis of data from six UK healthcare regulatory agencies was conducted. Three data sources were analysed using an a priori framework of eight dimensions of improvement capability identified from an extensive literature review. SETTING: The focus of the research study was the regulation of hospital-based care, which accounts for the majority of UK healthcare expenditure. Six UK regulatory agencies that review hospital care participated. PARTICIPANTS: Data sources included interviews with regulatory staff (n = 48), policy documents (n = 90) and assessment reports (n = 30). INTERVENTION: None-this was a qualitative, observational study. RESULTS: This research study finds that of eight dimensions of improvement capability, process improvement and learning, and strategy and governance, dominate regulatory assessment practices. The dimension of service-user focus receives the least frequency of use. It may be that dimensions which are relatively easy to 'measure', such as documents for strategy and governance, dominate assessment processes, or there may be gaps in regulatory agencies' assessment instruments, deficits of expertise in improvement capability, or practical difficulties in operationalising regulatory agency intentions to reliably assess improvement capability. CONCLUSIONS: The UK regulatory agencies seek to assess improvement capability to predict performance trajectories, but out of eight dimensions of improvement capability, two dominate assessment. Furthermore, the definition and meaning of assessment instruments requires development. This would strengthen the validity and reliability of agencies' assessment, diagnosis and prediction of performance trajectories, and support development of more appropriate regulatory performance interventions.

Improvement capability and performance: a qualitative study of maternity services providers in the UK.

OBJECTIVE: We explore variations in service performance and quality improvement across healthcare organisations using the concept of improvement capability. We draw upon a theoretically informed framework comprising eight dimensions of improvement capability, firstly to describe and compare quality improvement within healthcare organisations and, secondly to investigate the interactions between organisational performance and improvement capability. DESIGN: A multiple qualitative case study using semi-structured interviews guided by the improvement capability framework. SETTING: Five National Health Service maternity services sites across the UK. We focused on maternity services due to high levels of variation in quality and the availability of performance metrics which enabled us to select organisations from across the performance spectrum. PARTICIPANTS: About 52 hospital staff members across the five case studies in positions relevant to the research questions, including midwives, obstetricians and clinical managers/leaders. MAIN OUTCOME MEASURE: A qualitative analysis of narratives of quality improvement and performance in the five case studies, using the improvement capability framework as an analytic device to compare and contrast cases. RESULTS: The improvement capability framework has utility in analysing quality improvement within and across organisations. Qualitative differences in the configurations of improvement capability were identified across all providers but were particularly striking between higher and lower performing organisations. CONCLUSIONS: The improvement capability framework is a useful tool for healthcare organisations to assess, manage and develop their own improvement capabilities. We identified an interaction between performance and improvement capability; higher performing organisations appeared to have more developed improvement capabilities, though the meaning of this relationship requires further research.

Patient experience of centralized acute stroke care pathways.

BACKGROUND: In 2010, Greater Manchester (GM) and London centralized acute stroke care services into a reduced number of hyperacute stroke units, with local stroke units providing on-going care nearer patients' homes. OBJECTIVE: To explore the impact of centralized acute stroke care pathways on the experiences of patients. DESIGN: Qualitative interview study. Thematic analysis was undertaken, using deductive and inductive approaches. Final data analysis explored themes related to five chronological phases of the centralized stroke care pathway. SETTING AND PARTICIPANTS: Recruitment from 3 hospitals in GM (15 stroke patients/8 family members) and 4 in London (21 stroke patients/9 family members). RESULTS: Participants were impressed with emergency services and initial reception at hospital: disquiet about travelling further than a local hospital was allayed by clear explanations. Participants knew who was treating them and were involved in decisions. Difficulties for families visiting hospitals a distance from home were raised. Repatriation to local hospitals was not always timely, but no detrimental effects were reported. Discharge to the community was viewed less positively. DISCUSSION AND CONCLUSIONS: Patients on the centralized acute stroke care pathways reported many positive aspects of care: the centralization of care pathways can offer patients a good experience. Disadvantages of travelling further were perceived to be outweighed by the opportunity to receive the best quality care. This study highlights the necessity for all staff on a centralized care pathway to provide clear and accessible information to patients, in order to maximize their experience of care.

The potential role of cost-utility analysis in the decision to implement major system change in acute stroke services in metropolitan areas in England.

BACKGROUND: The economic implications of major system change are an important component of the decision to implement health service reconfigurations. Little is known about how best to report the results of economic evaluations of major system change to inform decision-makers. Reconfiguration of acute stroke care in two metropolitan areas in England, namely London and Greater Manchester (GM), was used to analyse the economic implications of two different implementation strategies for major system change. METHODS: A decision analytic model was used to calculate difference-in-differences in costs and outcomes before and after the implementation of two major system change strategies in stroke care in London and GM. Values in the model were based on patient level data from Hospital Episode Statistics, linked mortality data from the Office of National Statistics and data from two national stroke audits. Results were presented as net monetary benefit (NMB) and using Programme Budgeting and Marginal Analysis (PBMA) to assess the costs and benefits of a hypothetical typical region in England with approximately 4000 strokes a year. RESULTS: In London, after 90 days, there were nine fewer deaths per 1000 patients compared to the rest of England (95% CI -24 to 6) at an additional cost of £770,027 per 1000 stroke patients admitted. There were two additional deaths (95% CI -19 to 23) in GM, with a total costs saving of £156,118 per 1000 patients compared to the rest of England. At a £30,000 willingness to pay the NMB was higher in London and GM than the rest of England over the same time period. The results of the PBMA suggest that a GM style reconfiguration could result in a total greater health benefit to a region. Implementation costs were £136 per patient in London and £75 in GM. CONCLUSIONS: The implementation of major system change in acute stroke care may result in a net health benefit to a region, even one functioning within a fixed budget. The choice of what model of stroke reconfiguration to implement may depend on the relative importance of clinical versus cost outcomes.

Patient, carer and public involvement in major system change in acute stroke services: The construction of value.

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.

Conceptualizing and assessing improvement capability: a review.

PURPOSE: The literature is reviewed to examine how 'improvement capability' is conceptualized and assessed and to identify future areas for research. DATA SOURCES: An iterative and systematic search of the literature was carried out across all sectors including healthcare. The search was limited to literature written in English. DATA EXTRACTION: The study identifies and analyses 70 instruments and frameworks for assessing or measuring improvement capability. Information about the source of the instruments, the sectors in which they were developed or used, the measurement constructs or domains they employ, and how they were tested was extracted. RESULTS OF DATA SYNTHESIS: The instruments and framework constructs are very heterogeneous, demonstrating the ambiguity of improvement capability as a concept, and the difficulties involved in its operationalisation. Two-thirds of the instruments and frameworks have been subject to tests of reliability and half to tests of validity. Many instruments have little apparent theoretical basis and do not seem to have been used widely. CONCLUSION: The assessment and development of improvement capability needs clearer and more consistent conceptual and terminological definition, used consistently across disciplines and sectors. There is scope to learn from existing instruments and frameworks, and this study proposes a synthetic framework of eight dimensions of improvement capability. Future instruments need robust testing for reliability and validity. This study contributes to practice and research by presenting the first review of the literature on improvement capability across all sectors including healthcare.

Emerging hybridity: comparing UK healthcare regulatory arrangements.

Purpose Healthcare regulation is one means to address quality challenges in healthcare systems and is carried out using compliance, deterrence and/or improvement approaches. The four countries of the UK provide an opportunity to explore and compare different regulatory architecture and models. The purpose of this paper is to understand emerging regulatory models and associated tensions. Design/methodology/approach This paper uses qualitative methods to compare the regulatory architecture and models. Data were collected from documents, including board papers, inspection guidelines and from 48 interviewees representing a cross-section of roles from six organisational regulatory agencies. The data were analysed thematically using an a priori coding framework developed from the literature. Findings The findings show that regulatory agencies in the four countries of the UK have different approaches and methods of delivering their missions. This study finds that new hybrid regulatory models are developing which use improvement support interventions in parallel with deterrence and compliance approaches. The analysis highlights that effective regulatory oversight of quality is contingent on the ability of regulatory agencies to balance their requirements to assure and improve care. Nevertheless, they face common tensions in sustaining the balance in their requirements connected to their roles, relationships and resources. Originality/value The paper shows through its comparison of UK regulatory agencies that the development and implementation of hybrid models is complex. The paper contributes to research by identifying three tensions related to hybrid regulatory models; roles, resources and relationships which need to be managed to sustain hybrid regulatory models.

The 'dark side' of knowledge brokering.

Deploying knowledge brokers to bridge the 'gap' between researchers and practitioners continues to be seen as an unquestionable enabler of evidence-based practice and is often endorsed uncritically. We explore the 'dark side' of knowledge brokering, reflecting on its inherent challenges which we categorize as: (1) tensions between different aspects of brokering; (2) tensions between different types and sources of knowledge; and (3) tensions resulting from the 'in-between' position of brokers. As a result of these tensions, individual brokers may struggle to maintain their fragile and ambiguous intermediary position, and some of the knowledge may be lost in the 'in-between world', whereby research evidence is transferred to research users without being mobilized in their day-to-day practice. To be effective, brokering requires an amalgamation of several types of knowledge and a multidimensional skill set that needs to be sustained over time. If we want to maximize the impact of research on policy and practice, we should move from deploying individual 'brokers' to embracing the collective process of 'brokering' supported at the organizational and policy levels.

Understanding performance management in primary care.

Purpose Principal-agent theory (PAT) has been used to understand relationships among different professional groups and explain performance management between organisations, but is rarely used for research within primary care. The purpose of this paper is to explore whether PAT can be used to attain a better understanding of performance management in primary care. Design/methodology/approach Purposive sampling was used to identify a range of general practices in the North-west of England. Interviews were carried out with directors, managers and clinicians in commissioning and regional performance management organisations and within general practices, and the data analysed using matrix analysis techniques to produce a case study of performance management. Findings There are various elements of the principal-agent framework that can be applied in primary care. Goal alignment is relevant, but can only be achieved through clear, strategic direction and consistent interpretation of objectives at all levels. There is confusion between performance measurement and performance management and a tendency to focus on things that are easy to measure whilst omitting aspects of care that are more difficult to capture. Appropriate use of incentives, good communication, clinical engagement, ownership and trust affect the degree to which information asymmetry is overcome and goal alignment achieved. Achieving the right balance between accountability and clinical autonomy is important to ensure governance and financial balance without stifling innovation. Originality/value The principal-agent theoretical framework can be used to attain a better understanding of performance management in primary care; although it is likely that only partial goal alignment will be achieved, dependent on the extent and level of alignment of a range of factors.

Reorganising specialist cancer surgery for the twenty-first century: a mixed methods evaluation (RESPECT-21).

BACKGROUND: There are longstanding recommendations to centralise specialist healthcare services, citing the potential to reduce variations in care and improve patient outcomes. Current activity to centralise specialist cancer surgical services in two areas of England provides an opportunity to study the planning, implementation and outcomes of such changes. London Cancer and Manchester Cancer are centralising specialist surgical pathways for prostate, bladder, renal, and oesophago-gastric cancers, so that these services are provided in fewer hospitals. The centralisations in London were implemented between November 2015 and April 2016, while implementation in Manchester is anticipated in 2017. METHODS/DESIGN: This mixed methods evaluation will analyse stakeholder preferences for centralisations; it will use qualitative methods to analyse planning, implementation and sustainability of the centralisations ('how and why?'); and it will use a controlled before and after design to study the impact of centralisation on clinical processes, clinical outcomes, cost-effectiveness and patient experience ('what works and at what cost?'). The study will use a framework developed in previous research on major system change in acute stroke services. A discrete choice experiment will examine patient, public and professional preferences for centralisations of this kind. Qualitative methods will include documentary analysis, stakeholder interviews and non-participant observations of meetings. Quantitative methods will include analysis of local and national data on clinical processes, outcomes, costs and National Cancer Patient Experience Survey data. Finally, we will hold a workshop for those involved in centralisations of specialist services in other settings to discuss how these lessons might apply more widely. DISCUSSION: This multi-site study will address gaps in the evidence on stakeholder preferences for centralisations of specialist cancer surgery and the processes, impact and cost-effectiveness of changes of this kind. With increasing drives to centralise specialist services, lessons from this study will be of value to those who commission, organise and manage cancer services, as well as services for other conditions and in other settings. The study will face challenges in terms of recruitment, the retrospective analysis of some of the changes, the distinction between primary and secondary outcome measures, and obtaining information on the resources spent on the reconfiguration.

Explaining outcomes in major system change: a qualitative study of implementing centralised acute stroke services in two large metropolitan regions in England.

BACKGROUND: Implementing major system change in healthcare is not well understood. This gap may be addressed by analysing change in terms of interrelated components identified in the implementation literature, including decision to change, intervention selection, implementation approaches, implementation outcomes, and intervention outcomes. METHODS: We conducted a qualitative study of two cases of major system change: the centralisation of acute stroke services in Manchester and London, which were associated with significantly different implementation outcomes (fidelity to referral pathway) and intervention outcomes (provision of evidence-based care, patient mortality). We interviewed stakeholders at national, pan-regional, and service-levels (n = 125) and analysed 653 documents. Using a framework developed for this study from the implementation science literature, we examined factors influencing implementation approaches; how these approaches interacted with the models selected to influence implementation outcomes; and their relationship to intervention outcomes. RESULTS: London and Manchester's differing implementation outcomes were influenced by the different service models selected and implementation approaches used. Fidelity to the referral pathway was higher in London, where a 'simpler', more inclusive model was used, implemented with a 'big bang' launch and 'hands-on' facilitation by stroke clinical networks. In contrast, a phased approach of a more complex pathway was used in Manchester, and the network acted more as a platform to share learning. Service development occurred more uniformly in London, where service specifications were linked to financial incentives, and achieving standards was a condition of service launch, in contrast to Manchester. 'Hands-on' network facilitation, in the form of dedicated project management support, contributed to achievement of these standards in London; such facilitation processes were less evident in Manchester. CONCLUSIONS: Using acute stroke service centralisation in London and Manchester as an example, interaction between model selected and implementation approaches significantly influenced fidelity to the model. The contrasting implementation outcomes may have affected differences in provision of evidence-based care and patient mortality. The framework used in this analysis may support planning and evaluating major system changes, but would benefit from application in different healthcare contexts.