Procedural and 12-month in-hospital costs of primary infra-popliteal bypass surgery, infrapopliteal best endovascular treatment, and major lower limb amputation for chronic limb threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infrapopliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis. METHODS: We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study. RESULTS: Procedural HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P < .001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P < .001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P < .001, Kruskal-Wallis). CONCLUSIONS: Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis.

Publication of UK NICE Clinical Guidelines 168 has not significantly changed the management of leg ulcers in primary care: An analysis of The Health Improvement Network database.

BACKGROUND: NICE Clinical Guidelines (CG) 168, published in July 2013, recommend specialist vascular referral for all leg ulcers, defined as a break in the skin below the knee that has not healed within two weeks. AIM: To examine the impact of CG168 on the primary care management of leg ulcers using The Health Improvement Network database. METHODS: An eligible population of approximately two million adult patients was analysed over two 18-month periods before and after publication of CG168. Those with a new diagnosis of leg ulcers in each time period were analysed in terms of demographics, specialist referral and superficial venous ablation. RESULTS: We identified 7532 and 7462 new diagnoses of leg ulcers in the pre- and post-CG168 cohorts, respectively. Patients with a new diagnosis of leg ulcers were elderly (median age: 77 years both cohorts) and less likely to be male (47% both cohorts). There were 2259 (30.0%) and 2329 (31.2%) vascular service referrals in the pre- and post-CG168 cohorts, respectively (hazard ratio, 1.05, 95% CI: 0.99, 1.11, p = 0.096). The median interval between general practitioner diagnosis and referral was 1.5 days in both cohorts. Patients from both cohorts who were referred for a new diagnosis of leg ulcers were equally likely to receive superficial venous ablation. CONCLUSIONS: Disappointingly, we have been unable to demonstrate that publication of NICE CG168 has been associated with a meaningful change in leg ulcer management in primary care in line with guideline recommendations.

Assessment of novel vaccination regimens using viral vectored liver stage malaria vaccines encoding ME-TRAP.

Heterologous prime-boost vaccination with viral vectors simian adenovirus 63 (ChAd63) and Modified Vaccinia Ankara (MVA) induces potent T cell and antibody responses in humans. The 8-week regimen demonstrates significant efficacy against malaria when expressing the pre-erythrocytic malaria antigen Thrombospondin-Related Adhesion Protein fused to a multiple epitope string (ME-TRAP). We tested these vaccines in 7 new 4- and 8- week interval schedules to evaluate safety and immunogenicity of multiple ChAd63 ME-TRAP priming vaccinations (denoted A), multiple MVA ME-TRAP boosts (denoted M) and alternating vectors. All regimens exhibited acceptable reactogenicity and CD8+ T cell immunogenicity was enhanced with a 4-week interval (AM) and with incorporation of additional ChAd63 ME-TRAP vaccination at 4- or 8-weeks (AAM or A_A_M). Induction of TRAP antibodies was comparable between schedules. T cell immunity against the ChAd63 hexon did not affect T cell responses to the vaccine insert, however pre-vaccination ChAd63-specific T cells correlated with reduced TRAP antibodies. Vaccine-induced antibodies against MVA did not affect TRAP antibody induction, and correlated positively with ME-TRAP-specific T cells. This study identifies potentially more effective immunisation regimens to assess in Phase IIa trials and demonstrates a degree of flexibility with the timing of vectored vaccine administration, aiding incorporation into existing vaccination programmes.

BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial.

BACKGROUND: Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources. METHODS: The BASIL-3 trial is a UK National Institute for Health Research, Health Technology Assessment Programme-funded, multicentre, randomised controlled trial (RCT) comparing the clinical and cost-effectiveness of plain balloon angioplasty with or without bail-out bare metal stenting, drug-coated balloon angioplasty with or without bail-out bare metal stenting, and primary stenting with drug-eluting stents for SLI secondary to femoro-popliteal disease. Patients with 'multilevel' disease may receive aorto-iliac and/or infrapopliteal treatments concurrently with their randomised femoro-popliteal intervention. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the index limb or death from any cause. The primary outcome for the economic analysis is cost per quality-adjusted life year. Secondary outcome measures include overall survival, major adverse limb events, major adverse cardiac events, relief of ischaemic pain, healing of tissue loss, and quality of life. The required sample size has been calculated at 861 participants (287 on each arm). These patients will be recruited over 3 years and followed-up for between 2 and 5 years. DISCUSSION: BASIL-3 is a pragmatic RCT designed to reflect current UK clinical practice. The results will inform decision-making regarding the appropriateness of funding the use of drug-coated balloons and drug-eluting stents, by the NHS, for the management of SLI due to femoro-popliteal disease. TRIAL REGISTRATION: ISRCTN Registry, identifier: ISRCTN14469736 . Registered on 22 October 2015.

Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial.

BACKGROUND: Severe limb ischaemia is defined by ischaemic rest/night pain, tissue loss, or both, secondary to arterial insufficiency and is increasingly caused by infra-popliteal (below the knee) disease, mainly as a result of the increasing worldwide prevalence of diabetes. Currently, it is unknown whether vein bypass surgery or the best endovascular treatment (angioplasty or stenting) represents the optimal revascularisation strategy in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and cost-effective use of health care resources. METHODS/DESIGN: The Bypass vs. Angioplasty in Severe Ischaemia of the Leg - 2 Trial is a UK National Institute of Health Research, Health Technology Assessment funded, multi-centre randomised controlled trial that compares, at the point of clinical equipoise, the clinical and cost-effectiveness of a 'vein bypass first' and a 'best endovascular treatment first' revascularisation strategy for severe limb ischaemia due to infra-popliteal disease. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the trial limb or death from any cause. The primary outcome for the cost-effectiveness analysis is cost per quality-adjusted life year. Secondary outcomes include overall survival, quality of life, in-hospital mortality and morbidity, repeat and crossover interventions, healing of tissue loss and haemodynamic changes following revascularisation. Sample size is estimated at 600 patients. An economic evaluation will be conducted from the perspective of the National Health Service and comprise a 'within-study' analysis, based on prospectively collected trial data and a 'model-based' analysis, which will extrapolate and compare costs and effects beyond the study follow-up period. DISCUSSION: The BASIL-2 trial is designed to be pragmatic and represent current practice within the United Kingdom. Patients with severe limb ischaemia can only be randomised into the trial where clinical equipose exists. The advent of hybrid operating procedures should not be a barrier to randomisation, should a patient require inflow correction prior to tibial revascularisation. ISRCTN: 27728689 Date of registration: 12 May 2014.

The SPIRIT Action Framework: A structured approach to selecting and testing strategies to increase the use of research in policy.

The recent proliferation of strategies designed to increase the use of research in health policy (knowledge exchange) demands better application of contemporary conceptual understandings of how research shapes policy. Predictive models, or action frameworks, are needed to organise existing knowledge and enable a more systematic approach to the selection and testing of intervention strategies. Useful action frameworks need to meet four criteria: have a clearly articulated purpose; be informed by existing knowledge; provide an organising structure to build new knowledge; and be capable of guiding the development and testing of interventions. This paper describes the development of the SPIRIT Action Framework. A literature search and interviews with policy makers identified modifiable factors likely to influence the use of research in policy. An iterative process was used to combine these factors into a pragmatic tool which meets the four criteria. The SPIRIT Action Framework can guide conceptually-informed practical decisions in the selection and testing of interventions to increase the use of research in policy. The SPIRIT Action Framework hypothesises that a catalyst is required for the use of research, the response to which is determined by the capacity of the organisation to engage with research. Where there is sufficient capacity, a series of research engagement actions might occur that facilitate research use. These hypotheses are being tested in ongoing empirical work.

Health research, development and innovation in England from 1988 to 2013: from research production to knowledge mobilization.

This paper presents a critical analysis of the development of government policy and practice on health research, development and innovation over the last 25 years - starting from the publication of a seminal report from the House of Lords Science and Technology Committee in 1988. We first set out to map and analyse the trends in ideas and thinking that have shaped research policy and practice over this period, and to put the development of health research, development and innovation in the wider context of health system reforms and changes. We argue that though this has been a transformative period for health research, rather less progress has been made in the domains of development and innovation, and we offer an analysis of why this might be the case. Drawing on advances in our understanding about how research informs practice, we then make the case for a more integrative model of research, development and innovation. This leads us to conclude that recent experiments with Collaborations for Leadership in Applied Health Research and Care and Academic Health Science Centres and Networks offer some important lessons for future policy directions.

Whither British general practice after the 2004 GMS contract? Stories and realities of change in four UK general practices.

PURPOSE: The purpose of this article is to provide answers to two questions: what has been the impact of nGMS on practice organisation and teamwork; and how do general practice staff perceive the impact? DESIGN/METHODOLOGY/APPROACH: The article is based on comparative in-depth case studies of four UK practices. FINDINGS: There was a discrepancy between changes observed and the way practice staff described the impact of the contract. Similar patterns of organisational change were apparent in all practices. Decision-making became concentrated in fewer hands. Formally or informally constituted "elite" multidisciplinary groups monitored and controlled colleagues' behaviour for maximum performance and remuneration. This convergence of organisational form was not reflected in the dominant "story" each practice constructed about its unique ethos and style. The "stories" also failed to detect negative consequences to the practice flowing from its adaptation to the contract. ORIGINALITY/VALUE: The paper highlights how collective "sensemaking" in practices may fail to detect and address key organisational consequences from the nGMS.

Evidence into policy and practice? Measuring the progress of U.S. and U.K. policies to tackle disparities and inequalities in U.S. and U.K. health and health care.

Health policy in both the United States and the United Kingdom has recently shifted toward a much greater concern with disparities and inequalities in health and health care. As evidence for these disparities and inequalities mounts, the different approaches in each country present specific challenges for policy and practice. These differences are most apparent in the mechanisms by which the progress of such policies is measured. This article compares the United States' and United Kingdom's strategies to gauge the challenges for policymakers in order to inform policy and practice. A cross-national comparison of selected measurement mechanisms identifies lessons for policy and practice in both countries.

Towards systematic reviews that inform health care management and policy-making.

OBJECTIVES: To identify ways to improve the usefulness of systematic reviews for health care managers and policy-makers that could then be evaluated prospectively. METHODS: We systematically reviewed studies of decision-making by health care managers and policy-makers, conducted interviews with a purposive sample of them in Canada and the United Kingdom (n = 29), and reviewed the websites of research funders, producers/purveyors of research, and journals that include them among their target audiences (n = 45). RESULTS: Our systematic review identified that factors such as interactions between researchers and health care policy-makers and timing/timeliness appear to increase the prospects for research use among policy-makers. Our interviews with health care managers and policy-makers suggest that they would benefit from having information that is relevant for decisions highlighted for them (e.g. contextual factors that affect a review's local applicability and information about the benefits, harms/risks and costs of interventions) and having reviews presented in a way that allows for rapid scanning for relevance and then graded entry (such as one page of take-home messages, a three-page executive summary and a 25-page report). Managers and policy-makers have mixed views about the helpfulness of recommendations. Our analysis of websites found that contextual factors were rarely highlighted, recommendations were often provided and graded entry formats were rarely used. CONCLUSIONS: Researchers could help to ensure that the future flow of systematic reviews will better inform health care management and policy-making by involving health care managers and policy-makers in their production and better highlighting information that is relevant for decisions. Research funders could help to ensure that the global stock of systematic reviews will better inform health care management and policy-making by supporting and evaluating local adaptation processes such as developing and making available online more user-friendly 'front ends' for potentially relevant systematic reviews.

Introducing the Learning Practice--II. Becoming a Learning Practice.

RATIONALE, AIMS AND OBJECTIVES: This paper is the second of three related papers exploring the ways in which the principles of Learning Organizations (LOs) could be applied in Primary Care settings at the point of service delivery. METHODS: Based on a theoretical and empirical review of available evidence, here we introduce the process by which a Practice can start to become a Learning Practice (LP). RESULTS AND CONCLUSIONS: Steps taken to enhance both individual and organizational learning begin the process of moving towards a learning culture. Attention is given to the routines that can be established within the practice to make learning systematically an integral part of what the practice does. This involves focusing on all three of single-, double- and triple-loop learning. Within the paper, a distinction is made between individual, collective and organizational learning. We argue that individual and collective learning may be easier to achieve than organizational learning as processes and systems already exist within the Health Service to facilitate personal learning and development with some opportunities for collective and integrated learning and working. However, although organizational learning needs to spread beyond the LP to the wider Health Service to inform future training courses, policy and decision-making, there currently seem to be few processes by which this might be achieved. This paper contributes to the wider quality improvement debate in three main ways. First, by reviewing existing theoretical and empirical material on LOs in health care settings it provides both an informed vision and a set of practical guidelines on the ways in which a Practice could start to effect its own regime of learning, innovation and change. Second, it highlights the paucity of opportunities individual general practitioner practices have to share their learning more widely. Thirdly, it adds to the evidence base on how to apply LO theory and activate learning cultures in health care settings.

Clinical governance and the learning organization.

AIM: This paper compares and contrasts clinical governance and organizational learning. BACKGROUND: Clinical governance represents one of the most significant policy developments in recent years. It places on all health care delivery organizations a statutory duty to develop the systems, standards and processes necessary to improve health care quality and manage risk. At the same time, many health care organizations are seeking new ways in which learning can be retained and deployed more widely within the organization (organizational learning). KEY ISSUES: Both approaches emphasize cultural changes as essential underpinnings to quality improvement. However, the two approaches also differ fundamentally in their logic of action. Clinical governance is essentially 'top down', being built around formal standards, established procedures, and regular monitoring and reporting. In contrast, organizational learning emphasizes 'bottom up' changes in values, beliefs and motivations in such a way that learning and change are prioritized. The challenge for managers and practitioners lies in seeking a creative tension between these two contrasting styles of organizational change.

Managing change in the culture of general practice: qualitative case studies in primary care trusts.

OBJECTIVES: To explore the potential tension between the need for managers to produce measurable change and the skills required to produce cultural change, and to investigate how managers of primary care trusts are attempting to deal with this tension. DESIGN: Qualitative case studies using data derived from semistructured interviews and a review of published documents. An established cultural framework was to used to help interpret the findings. SETTING: Six primary care trusts in England purposefully sampled to represent a range of cultural, structural, geographical, and demographic characteristics. PARTICIPANTS: 42 interviews with 39 different senior and middle primary care trust managers conducted over an 18 month period. RESULTS: We found two distinct and polarised styles of management. One group of managers adopts a directive style and challenges the prevailing norms and values of clinicians, an approach characteristically seen in organisations with hierarchical cultures. This group is made up mostly of senior managers who are driven principally by the imperative to deliver a political agenda. Managers in the second group are more inclined to work with the prevailing cultures found in general practice, attempting to facilitate change from within rather than forcing change from outside. This management style is characteristically seen in organisations with a clan-type culture. The approach was manifest mostly by middle managers, who seem to act as buffers between the demands of senior managers and their own perception of the ability and willingness of health professionals to cope with change. The different management approaches can lead to tension and dysfunction between tiers of management. CONCLUSIONS: The development of primary care depends on high quality managers who are able to draw on a range of different management skills and styles. Managers are most likely to be effective if they appreciate the merits and drawbacks of their different styles and are willing to work in partnership.

Does organisational culture influence health care performance? A review of the evidence.

OBJECTIVE: To review the evidence for a relationship between organisational culture and health care performance. METHODS: Qualitative comprehensive review: all empirical studies exploring a relationship between organisational culture (broadly defined) and health care performance (broadly defined) were identified by a comprehensive search of the literature. Study methods and results were analysed qualitatively to provide a narrative review with integrative discussion. RESULTS: Ten studies met the inclusion criteria. There was considerable variation in the design, study setting, quality of reporting and aspects of culture/performance considered. Four of the ten studies reviewed in detail claimed to have uncovered supportive evidence for the hypothesis that culture and performance are linked. All the other studies failed to find a link, though none provided strong evidence against the hypothesis. CONCLUSIONS: There is some evidence to suggest that organisational culture may be a relevant factor in health care performance, yet articulating the nature of that relationship proves difficult. Simple relationships such as 'strong culture leads to good performance' are not supported by this review. Instead, the evidence suggests a more contingent relationship, in that those aspects of performance valued within different cultures may be enhanced within organisations that exhibit those cultural traits. A striking finding is the difficulty in defining and operationalising both 'culture' and 'performance' as variables that are conceptually and practically distinct. Considerably greater methodological ingenuity will be required to unravel the relationship(s) between organisational culture(s) and performance(s). Current policy prescriptions, which seek service improvements through cultural transformation, are in need of a more secure evidential base.

Implementing culture change in health care: theory and practice.

OBJECTIVES: To review some of the key debates relating to the nature of organizational culture and culture change care organizations and systems. METHODS: A literature review was conducted that covered both theoretical contributions and published studies of the processes and outcomes of culture change programmes across a range of health and non-health care settings. RESULTS: There is little consensus among scholars over the precise meaning of organizational culture. Competing claims exist concerning whether organizational cultures are capable of being shaped by external manipulation to beneficial effect. A range of culture change models has been developed. A number of underlying factors that commonly attenuate culture change programmes can be identified. Key factors that appear to impede culture change across a range of sectors include: inadequate or inappropriate leadership; constraints imposed by external stakeholders and professional allegiances; perceived lack of ownership; and subcultural diversity within health care organizations and systems. CONCLUSIONS: Managing organizational culture is increasingly viewed as an essential part of health system reform. To transform the culture of a whole health system such as the UK National Health Service would be a complex, multi-level, and uncertain process, comprising a range of interlocking strategies and supporting tactics unfolding over a period of years.

Health care report cards: implications for vulnerable patient groups and the organizations providing them care.

Standardized public reporting on the quality of health care (report cards) offers an opportunity to empower purchasers and consumers so that they can make choices that can result in better health care for less money. However, not all population subgroups are equally well served by the publication of such data. In particular, vulnerable patient groups such as the poor, the less educated, the chronically sick, and members of ethnic or linguistic minorities may find issues of importance to them largely neglected. In addition, the way that report card data are collected, analyzed, and presented may further marginalize the experiences of these groups who in any case are already underserved by the health system. This observation also has important implications for health care providers who serve primarily large numbers of vulnerable patients. The differential impacts of report card data on vulnerable patient groups (and their providers) need to be addressed by researchers and policy makers if access issues are not to be damaged further by the providers' pursuit of quality and value.