Title: The Design, Development, Commissioning and Evaluation of Patient Focused Vascular Services
Funder: Department of Health and Social Care

Abstract: Aims and Objectives The programme will draw together the necessary tools to establish high quality sub-specialist vascular services. Key objectives are; 1) the characterisation of service arrangements, activity and outcomes, 2) the development of outcome measures covering the major disease areas within vascular services, suitable for; i) clinical use, ii) monitoring service quality and iii) cost utility modelling, 3) the identification and valuation of key service attributes of importance to users and 4) the development of a set cost utility models for the major disease areas in vascular services. Background and Rationale Clinical services are becoming increasingly complex and sub-specialised, leading to tensions between maximising efficiency, cost effectiveness and other desirable features such as local responsiveness and equity. These pressures are particularly marked in vascular services, where there have been rapid changes due to the development of a new sub-specialty and the introduction of new procedures for diagnosis, treatment and screening. There is a need for service reconfiguration and their design, implementation and evaluation will require comprehensive outcome indicators and an understanding of the aspects of service provision that are important to service users and clinicians. The methodology and outputs of this study will be relevant across many areas of health service provision. Research Environment The School of Health and Related Research (ScHARR) at the University of Sheffield and NHS Sheffield, have extensive experience and an international reputation in all methodological areas required for this programme. All necessary skills can be provided within the grouping, which has an excellent history of delivering such research to inform NHS practice, including extensive work with the HTA programme and NICE. Research Plan The research programme includes sub-studies which include analysis of hospital episode statistics and surveys of current working arrangements to relate workload, service provision and outcomes and to develop measures that can monitor service quality. Case studies in reconfigured services will allow detailed evaluation of the relationship between service change and outcome measures. The programme will identify and/or develop preference-based outcome measures in each of the main disease areas, along with a mechanism for collecting and analysing the data in electronic format (the ePAQ-VAS). These will be validated for clinical use and to generate QALY estimates. The programme will develop decision analytic economic (cost utility) models to characterise the pathways of care for the main disease areas within vascular services. These will allow the evaluation and optimisation of care pathways, the prediction of the effects of different service models and the evaluation of the potential cost effectiveness of new technologies or changes in practice. Projected Outputs and Dissemination The programme will develop:- Measures of workload, activity, case mix and outcomes from existing datasets. Generic and condition-specific preference-based measures for assessing vascular outcomes that can be used to generate utilities for QALY estimation. An electronic format for collection of outcome measures. A library of utility valuations for health outcomes related to vascular conditions. Economic models covering the main disease areas within vascular services. A methodology for considering the effect of incorporating preferences for other attributes of services into cost utility modelling using a &ldquo;net health benefit&rdquo; approach. These instruments and models will be made widely available to organisations responsible for the commissioning and provision of vascular services. Relevant Expertise Of The Research Team The research team is based upon a group of academics, methodological and clinical experts who have worked together using similar methodologies and have successfully completed previous related studies. The work builds on the team that undertook previous work on vascular service configuration for the HTA and researchers who have carried out leading work informing UK practice in respect to outcome measurement, economic modelling and the development of Patient Reported Outcome Measures (PROM). Justification Of Costs The main costs of the project relate to salaries for research staff. The programme includes several related sub-studies, with both qualitative and quantitative methodology, that will require a range of expertise. Many of the studies, including the data analysis, systematic reviews relating to many clinical areas and qualitative research including focus groups and interviewing will be labour intensive. Management and Governance The programme comprises four workstreams, each having separate management groups led by a co-applicant. The lead applicant, workstream leads and patient representatives will constitute a trial steering group with independent members chaired by an independent clinician. An independent expert working group will be developed to advise on clinical aspects of the work and help in the development of the outcome measures. The group will also include methodological experts to advise on methodological issues. PPI The programme has already involved patient representatives and an existing patient council. The programme will include the further development of a patient panel specific to vascular services that will advise on issues such as participant recruitment, surveys and interviews and will be represented on the steering group.

Lay abstract: Planning and commissioning healthcare is becoming increasingly complex. One important factor in commissioning care is the need to predict the impact of any changes on service users, with tensions between desire for local access, service quality and viability. Services require sufficient workload to justify full facilities, while staff must maintain skills and competence. In the management of vascular disease, the introduction of many new techniques, high emergency workload, and separate emerging specialist areas has meant that reconfiguration is necessary. There is a need to design comprehensive pathways for the optimal delivery of vascular services, and these need to be planned, implemented and evaluated. This research programme will develop tools to design, develop and monitor the provision of vascular services. It will use data collected by the NHS about treatments, and will ask service users and clinicians how various aspects of services are valued and how best to measure outcomes of treatment and the quality of services. It will evaluate how current treatments are provided in different locations and the main issues that impact on local arrangements. It will assess the strength of service users , clinicians and stakeholders preferences concerning how services are provided, including clinical outcomes, accessibility, equity and processes of care. The research will develop measures to assess how treatments impact on quality of life, and an electronic system enabling users to provide information about their condition in clinics or on-line. This will help clinicians to plan treatment and measure its effectiveness and cost effectiveness. The final outputs of the programme will include computer models to identify and predict the most effective ways of delivering vascular services and a set of measures to evaluate clinical outcomes and to assess and monitor service quality and the effects of reorganisation. The methods and outcomes of the programme will have potential value for many other services facing similar pressures. The research will be based in the University of Sheffield and carried out by a team including academics and clinicians within the School of Health and Related Research (ScHARR), in collaboration with NHS Sheffield, Sheffield Teaching Hospitals NHS Trust and Sheffield Hallam University. Members of the team have a wide experience of different research methods and have examined how services are provided within vascular and other clinical areas. ScHARR is one of the largest health services research groups in the UK and has a track record of delivering high quality research. The programme will enable the NHS to predict the best ways of commissioning vascular services and measure how effective arrangements are from the users perspective.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: CARDIOVASCULAR