Research, Service Evaluation & Clinical Audit Plan

Research, Service Evaluation & Clinical Audit Plan A focus on evidence based community healthcare Date: March 2012 Author: Sarah Williams Version: v7 Research, Service Evaluation & Clinical Audit Plan v7 1

Version Date Author Amendments Distribution Version 1 April 2011 S Williams J Hillier Version 2 May 2011 S Williams Add in deliverables R&D Committee Version 3 June S Williams Edit following J Hillier comments at committee meeting Version 4 19 th June S Williams J Hillier Version 5 28 Nov S Williams Add in IP statement Version 6 4 th Feb 2012 S Williams Stronger emphasis on evaluation/ Tony Snell Version 6.1 Version 6.2 Version 7.0 Version 7.1 16 th Feb 2012 23 rd Feb 2012 11 th March 2012 16 th March 2012 S Williams S Williams S Williams S Williams audit/ outcomes Proposed team structure and KPIs Change in order of priorities Incorporate justification for centralised team. Incorporate paper on Clinical Audit Comments from Judy Hillier Tony Snell & Directors NEDs Assurance Committee Assurance Committee, Trust Board Research, Service Evaluation & Clinical Audit Plan v7 2

Research, Service Evaluation & Clinical Audit Plan v7 3

Executive Summary Changes to the NHS landscape are resulting in an increased shift towards community based health care, greater efficiencies and a focus on patient centered clinical outcomes. Solent NHS Trust aspires to be a leader in the development of evidenced based innovative approaches to community healthcare. This paper proposes a co-ordinated corporate approach to the implementation of evidence based healthcare based on findings from research, service evaluation and clinical audit. This will provide an evidence base to support the national drive for the transformation towards patient centered integrated pathways community based healthcare. It is proposed that this evidence is also exploited to inform and evaluate cost improvement plans and service improvement initiatives. This plan is underpinned by a philosophy of and commitment to patient and public involvement in research, service evaluation and clinical audit activity within the Trust. The Solent NHS Trust Research, Service Evaluation and Clinical Audit Plan will embrace six key strategic goals: 1. To establish a new centralised Research, Service Evaluation and Clinical Audit Team. This will provide expertise and support for staff across this continuum of activity in terms of methodology, governance and data analysis, thereby effecting efficiencies and clarity at an organisational level. 2. To provide (via this team) an organisational hub for the collation and incorporation of best evidence, research, evaluation and clinical audit findings into service delivery, measurement of outcomes and cost improvement. This evidence can be exploited to satisfy the requirements of local commissioners, national reporting obligations, staff appraisal and revalidation, clinical service line reporting and performance management and most importantly by implementing change as a consequence, improve quality of patient care. 3. To prioritise research, evaluation and clinical audit projects that will provide a strong evidence base for continuous improvement in community based health care and support national priorities around transformation. 4. To increase the scope of research activity and the number of patients and staff that are engaged with research projects. Within this, ensure that national performance indicators for research are achieved, with a view to maximising research income for the Trust. 5. To develop/ consolidate the registration and governance process around service evaluation and clinical audit, and to develop a strategic approach to evaluation and clinical audit planning across all services. 6. To embrace a culture of patient and the public involvement in research, service evaluation and clinical audit. Research, Service Evaluation & Clinical Audit Plan v7 4

1. Introduction 1.1 Changes to the NHS landscape are resulting in an increased shift towards community-based health care, greater efficiencies, a need to evidence innovation and continuous improvement and a focus on patient centered clinical outcomes. 1.2 Solent NHS Trust aspires and has the expertise to be a leader in the development of evidence based innovative approaches to community healthcare. 1.3 This paper proposes a co-ordinated corporate and strategic approach to the implementation of evidenced healthcare, based on findings from research, service evaluation and clinical audit. It proposes that these three activities are incorporated into and facilitated by one team within the Trust. 1.4 A centralised team will offer efficiencies in terms of forward planning and the integration of evidence, and in terms of the skills and expertise to facilitate research, service evaluation and clinical audit. 1.5 The team will co-ordinate an organisation-level evidence base to support the national drive for the transformation towards patient centered integrated pathways community based healthcare. Successful transformation will require a strong evidence base to support the bid for Foundation Trust Status, and meet the requirements of local commissioners and national reporting requirements, particularly around quality and clinical outcome measures. A strong evidence base will also afford: the delivery of successful cost improvement programs; the meeting of contractual requirements; a driver for continual service improvement; and success in national programmes such as the revalidation of doctors and in future nurses and AHPs. 1.6 A strong culture of research and evidence based practice will attract high quality staff, improve service delivery and patient care, and provide a healthy income stream for the Trust. 1.7 This plan is underpinned by a philosophy of and commitment to patient and public involvement in research, service evaluation and clinical audit activity within the Trust. 1.8 The Solent NHS Trust Research, Service Evaluation and Clinical Audit Plan will embrace six key strategic goals: 1. To establish a new, centralised Research, Service Evaluation and Clinical Audit Team. This will provide expertise and support for staff across this continuum of activity in terms of methodology, governance and data analysis, thereby affording efficiencies and clarity at an organisational level. 2. To provide (via this team) an organisational hub for the collation and incorporation of best evidence, research, evaluation and clinical audit findings into service delivery, measurement of outcomes and cost improvement. This evidence can be exploited to satisfy the requirements of local commissioners, national reporting obligations, staff appraisal and revalidation, clinical service line reporting and performance management. 3. To prioritise research, evaluation and clinical audit projects that will provide a strong evidence base for continuous improvement in community based health care and support national priorities around transformation. 4. To increase the scope of research activity and the number of patients and staff that are engaged with research projects. Within this, ensure that national performance indicators for research are achieved, with a view to maximising research income for the Trust. 5. To develop/ consolidate the registration and governance process around service evaluation and clinical audit, and to develop a strategic approach to evaluation and clinical audit planning across all, to underpin evidence based continuous improvement. 6. To embrace a culture of patient and public involvement in research, service evaluation and clinical audit. Research, Service Evaluation & Clinical Audit Plan v7 5

2. Key Strategic Goal 1: To establish a new, centralised Research, Service Evaluation and Clinical Audit Team. It is proposed that research, service evaluation and clinical audit activity is co-ordinated by one team. Amalgamating this activity will afford the following benefits: a. It will allow a more strategic approach to the collation of the continuum of evidence. b. It can provide a centralised source of evidence from across this continuum to satisfy local and national reporting requirements, contractual obligations and to support continuous improvement in service delivery. c. It will create efficiencies in terms of the skills and expertise around project management, study design, data collection and analysis and continuous improvement. d. It will ensure clarity for staff with a one stop shop for support and facilitation in the collection of evidence and its use in practice e. It will ensure sound systems of governance around all areas of research, service evaluation and clinical audit activity 2.1 A strategic approach to the collation of evidence The evidence from research, service evaluation and clinical audit lies on a continuum from the measurement of service based achievements against defined standards through to the sourcing of new knowledge with opportunities for generalization across the health economy (see appendix 2). Each source of evidence overlaps and feeds the other, and it is the collation of these difference types of information that together form a powerful platform from which to plan and deliver service delivery and improvement. It makes sense, therefore, that the planning and prioritization of these activities, and the amalgamation of the evidence is overseen by one department to allow for a strategic and logical approach. This in turn enables forward planning of projects according to need and a cycle of activity to feed into a programme of continuous improvement across services, be they related to the delivery of healthcare, continuous quality improvement, cost improvement or innovation. Specifically a centralised team would be well placed to: a. Work with clinical divisions to identify research, evaluation and clinical audit needs, and to evidence continuous improvements and clinical outcome measures. b. Work with clinical divisions to support the collation of evidence to support CIPS (Collation of baseline measures, the identification of clear success measures, and to provide evaluations of the impact and success of the CIPS). c. Ensure that evidence and the skills to ensure its quality are collated centrally and used efficiently to inform practice and drive better clinical outcomes. d. Ensure active participation in national initiatives around research and clinical audit, and link effectively with initiatives such as the HIEC 2.2 The provision of a centralised source of evidence A strong evidence base is critical to effective service delivery. Furthermore, every service has contractual local and national reporting requirements, be they related to evaluations, clinical audit Research, Service Evaluation & Clinical Audit Plan v7 6

or performance management. Similarly, any cost improvement programme or intervention should be grounded in evidence in their conceptualization, delivery and evaluation phases. Some of this evidence can and should be sourced from national and international literature from research, evaluations and case studies, for instance, or from guidelines from institutions such as NICE and the Royal Colleges. Much of the data collection, however, needs to be locally Trust based. The range of specialist healthcare services delivered by Solent NHS Trust presents a risk around disparate collection of evidence, often collected in isolation with minimal reference to wider Trust or national objectives, little or no methodological support, and limited recognition. There is an increasing urgency around ensuring an ability to demonstrate and draw upon a strong evidence base at a corporate level. For example: Monitor, the independent regulator of NHS Foundation Trusts require evidence of continuous improvement (to include evidence based practice) and expect clinical audit to form an important part of its recommended quality governance framework. The Portsmouth Clinical Commissioning Group have recently expressed a requirement for an evidence base to demonstrate continuous improvement in service delivery, and this is highly likely to be similar for all commissioners. Contractual obligations generally require reporting of results of clinical audit and service evaluation The Care Quality Commission requires reporting on research, evaluation and clinical audit, particularly in the annual Quality Account. The National Institute for Health Research requires an increase in the number of patients recruited into clinical studies every year, Programmes such as the revalidation of doctors (soon to be extended to nurses and AHPs) require evidence of clinical audit, improved clinical outcomes and initiatives around service improvement (to include research or evaluation). Successful Cost Improvement Programmes require a strong evidence base for their development and ongoing evaluation. It is proposed that a central, co-ordinated approach to the collation of evidence will provide an invaluable resource for the Trust in meeting this range of requirements. A centralized source of evidence also affords a strong and efficient culture of evidence based practice. 2.3 Efficiencies around support and expertise Research, service evaluation and clinical audit when done well, all draw on a similar knowledge and skill base. Each is concerned with good design, reliable data collection methodology and accurate data analysis. The cross cutting aspect of this skills base and expertise can be most efficiently utilized if all activity is supported from within one team. This team will have the skills to support and facilitate research, evaluation and clinical audit across the organization. Furthermore, if the evidence is collated in one central place, then staff from within the team and across the Trust will be able to exploit and triangulate that evidence effectively. 2.4 Clarity for staff Staff from services across Solent NHS Trust often require support in research, evaluation or audit activity but it is often not immediately clear which activity it is that is being undertaken. The activities often overlap and there is often a need to clarify which would be most appropriate. If all of the activity is supported and facilitated by one team, the support for any data collection becomes more efficient and can be easily identified. Moreover, all training materials, policies and processes Research, Service Evaluation & Clinical Audit Plan v7 7

can be available in one place. This allows for clarity amongst staff across the Trust. It also affords efficiencies in the delivery of training and facilitation. 2.5 Sound systems of governance There are already strong governance processes around research. It is clear, however, that these processes for checking the quality and ethics of studies do not currently extend to service evaluation or clinical audit. This presents a risk to the organization in terms of poor data, poor reporting, and potential ethical (particularly information governance) breaches. This plan proposes that the skills and governance systems within which research is embedded are applied in principle to service evaluation and clinical audit. The principles and skills required for governance around each activity are similar, and the transfer of arrangements where appropriate would be easily achievable within one team. Where governance principles are co-ordinated and coherently applied across activity types, they are easier to manage, promote and assure across staff and service groups. 3. Key Strategic Goal 2: To provide an organisational hub for the collation and incorporation of best evidence, research, evaluation and clinical audit findings and to support clinicians and management staff to collect and consolidate the incorporation of best evidence, research, evaluation and clinical audit findings into service delivery. This paper proposes that the collation of evidence is coordinated and supported by a team which will: a. Ensure that evidence from research, innovation and clinical audit at Solent NHS Trust is fed back into services b. Ensure that this evidence is linked to outcomes and feeds into service or cost improvement plans c. Ensure that there is adequate expertise and support with data collection and analysis and associated training for staff. 3.1 Ensuring that evidence from research and innovation is fed back into services This will be assured by: a. Consolidating partnerships between services and academic institutions. It is important that there are tangible links between academic leads and relevant innovation. b. Making access to research publications and findings a condition of research approval in the Trust c. Ensuring these publications and evaluation/ clinical audit findings are available on the intranet d. Providing training for staff in critical appraisal of research evidence, in accessing relevant evidence and innovation and in evidence based practice e. Providing training for staff in the design and implementation of service evaluation and clinical audit. f. Hosting an annual Solent NHS Trust Research, Evaluation and Clinical Audit Conference. Trust staff and students will be encouraged to present at this conference. Research, Service Evaluation & Clinical Audit Plan v7 8

3.2 Ensure that this evidence is linked to outcomes and feeds into service or cost improvement plans a. As part of the evaluation registration and governance process, ensure a system is in place for translating evaluation and clinical audit findings into service improvement plans, cost improvement plans or refined outcome measures. b. Develop forward plans for service evaluations and clinical audits to provide the evidence base needed and to support the cycle of continuous improvement through PDSA (Plan, Do, Study, Act) cycles. c. Ensure a coordinated and interlinked approach to the collection of evidence across the research, evaluation and clinical audit continuum. 3.3 Ensure that there is adequate expertise for support with data collection and analysis and associated training for staff a. Develop an Evaluation and Clinical Audit Manager post to lead on the service evaluation and clinical audit governance and planning process and to provide expertise in methodology, data analysis and in the translation of evidence into action/service and cost improvement. b. Create supporting posts to work across clinical divisions in respect to evaluation and clinical audit planning, implementation and action planning. This will afford the necessary support for the revalidation of doctors, nurses and AHPs and for the identification of appropriate clinical outcome measures. 4. Key Strategic Goal 3 Prioritise the development of research, service evaluation and clinical audit projects that will provide an evidence base to improve community based care and support national priorities around transformation The national agenda for patient care is to promote more community based health care and patient choice. Solent NHS Trust offers a huge range of specialist and often innovative services. To support and further promote these services and interventions, and to underpin the national agenda, there is a need for a better evidence base around the impact and outcomes of these interventions and the whole system benefits of the transformed community services. Solent NHS Trust will therefore prioritise research, service evaluation and clinical audit projects that can support the provision of this evidence base (and by implication, support profitable transformation schemes). They will also prioritise research, evaluation and clinical audit projects that can offer value added evidence to priority improvement areas identified by the Trust, for instance in its annual Quality Account. These can be reviewed and identified annually, but examples include: a. Avoidance of hospital admission, via initiatives such as Virtual wards b. Community services for the older patient and end of life care c. Community services for children and young people d. Outcomes and impacts of substantial service delivery areas within the Trust such as sexual health, substance misuse and offender health e. Management of long term conditions f. Outcomes associated with patient centred integrated pathways of community based healthcare Research, Service Evaluation & Clinical Audit Plan v7 9

g. The use of telehealth 5. Key Strategic Goal 4: Facilitate and increase the scope of research activity and the number of patients and staff that are engaged with research projects. a. Increase the number of patients that are involved in research studies and the number of studies that are open to recruitment. b. Focus on increasing the number of commercial trials. c. Enable the above by investing in staff and providing incentives for research activity. d. Ensure that national targets for the above are met, with a view to ensuring and increasing research income for the Trust and the individuals and teams involved. 5.1 Increase the number of patients recruited to research studies& the number of studies open to recruitment Access to clinical trials is an NHS constitutional right of patients and allows them the chance to benefit from new treatments, interventions and medicines. Evidence suggests that patients who receive care in research active institutions have better health outcomes. The opportunity to engage in research also attracts high quality staff and productive external stakeholder relationships. The number of patients recruited to research studies and the number of studies open to recruitment will be increased by: a. Consistent horizon scanning for active studies, and for investigators looking for Trusts to act as hosts for their studies. b. Consolidating and building on relationships with research active partners such as the Universities, Research Networks and Research Design Services. c. Ensuring that Solent NHS Trust s Research activity, interest and achievements have high visibility via the internet and written publications. d. Ensuring streamlined and proportionate governance processes to attract researchers to Solent NHS Trust. e. Facilitating research in services with high patient numbers such as GP practices, walk-in centres and offender institutions. This will include innovative ways of inclusion for instance, suggesting that out-of-hours services or walk-in centres might be suitable for studies traditionally limited to GP practices; or accessing traditionally marginalised or hard to reach groups such as the homeless or those with learning disabilities. f. Maximising accrual mapped to Solent rather than other Trusts via appropriate infrastructure (such as research nurse time for consenting patients). 5.2 Focus on commercial studies In line with a national drive to increase research associated with the life sciences industry, and new targets to increase commercial trials in NHS Trusts, this will be a priority for Solent NHS Trust. This is vital to meet local performance management targets, and to provide income for research within the Trust. To attract commercial trials to the Trust, Solent NHS Trust will: a. Ensure there is clinical engagement and willingness to carry out commercial trials. b. Work with the CLRN and other research networks to identify suitable trials for Solent NHS Trust. c. Engage directly with pharmaceutical and medical device companies and CROs working on their behalf to promote Solent as a preferred research site. Research, Service Evaluation & Clinical Audit Plan v7 10

d. Facilitate trials with support and resource in terms of admin support, protected time and research staff (for instance research nurses). e. Incentivise staff via the development of an income distribution policy to enable investigators to reinvest earnings from research back into the development of further research capability. f. Ensure there are adequate patient numbers to meet delivery targets set by commercial companies. g. Ensure governance processes are streamlined to guarantee approvals do not cause unnecessary delay. 5.3 Invest in staff Of prime importance is the need to focus on the research strengths of staff employed by Solent NHS Trust and identify potential areas of growth. There is a particular need to engage with clinical leads to encourage research activity within their service area. It is also essential that Solent NHS trust increases the capacity to support research by focusing on training and development across its staff base. Support for staff to undertake research or research training can serve as a key driver to develop capacity, encourage activity and foster a culture of research in the Trust. It can also help to improve retention of staff and attract high caliber applicants to the Trust. Specifically, we will: a. Support staff to identify studies open in their service area and enable them to become more research active. b. Engage with medics and other clinicians to encourage and facilitate research activity in their service area. c. Provide training in clinical research and in the use of evidence in practice for new and developing investigators. d. Provide expert support in the sourcing of relevant evidence, in ethics and governance approval processes, and in study design and data analysis where necessary. e. Support clinical research fellowships and PhD studentships via partnerships with academic institutions. f. Attract a research active workforce. New appointments should consider including a requirement in the job description for research skills and interests that will be in the benefit of the Trust. Existing posts can consider research as part of the appraisal and objective setting process. g. Ensure adequate management support of research studies. h. Support students to carry out research within Solent NHS Trust. i. Celebrate and promote achievement. It is worth noting that each of the above are equally applicable to service evaluation and clinical audit activity across clinical divisions in the Trust. 5.4 Increase research income for the Trust Research income can be maximized by achieving the above, and by meeting performance metrics set by the NIHR, and monitored by the Hampshire and IOW CLRN. Specifically: a. The annual target for numbers of patients recruited into studies must be realistically negotiated and then achieved. b. The numbers of studies approved must increase and must be approved within national metric timeframes. In addition attracting NIHR funded grants as an NHS host organisation will increase our Research Capability Funding Allocation (previously Flexibility and Sustainability Funding). c. Studies must be monitored to ensure they are recruiting to time and to target. d. The number of commercial trials opened in Solent NHS Trust must increase to maximize direct earnings and indirect performance management associated funding from the CLRN. Research, Service Evaluation & Clinical Audit Plan v7 11

e. The costing of studies must ensure that all direct costs incurred are covered, and that there is some allocation for overhead and research development costs. These measures will be monitored by a set of Key Performance Indicators, which will be presented to the Board. These are outlined in Appendix 4. 6. Key strategic goal 5: To develop/ consolidate the registration and governance process around service evaluation and clinical audit, and to develop a strategic approach to evaluation and clinical audit planning across all services. This will be supported by: a. The development of a service evaluation registration and governance policy. This policy will enable a central point of registration for evaluations and a means of assuring that they are of sufficient quality to meet ethical and contractual obligations. b. The development of the clinical audit registration process to dovetail with the service evaluation process. There is currently no formal process for registering a service evaluation in Solent NHS Trust. This presents a risk in terms of a potential quality issue, but also in terms of lost information and subsequent benefits for the Trust. A recent review of the clinical audit systems and processes in the Trust highlighted similar risks. It noted that there is a substantial lack of information on the current clinical audit programme and a lack of clarity around priorities. Furthermore, it noted that there is currently no system to assure the quality of the activity or the impact of audit in terms of outcomes. It reports inconsistency in the quality of the clinical audit reports and no recognised system for sharing findings and information across the wider range of services or for feeding into a corporate action plan. The report notes that although there are pockets of excellence within services, and a number of clinical audits being undertaken, they remain isolated within services and learning is rarely shared with other services or being recognised by the Board. Informal consultation with clinical leads in the Trust has also highlighted a desire for more clarity around the processes for clinical audit, for support to undertake and plan audit activity and for co-ordination of audit cycle planning and feeding findings into continuous service improvement. Interestingly, the National Advisory Group on Clinical Audit are reviewing the ways in which NHS Trusts can deliver on their obligations this is in response to a growing concern about the scope and ability of audit staff to meet the challenges and expectations that they face. One of the aims of this group is to support the reinvigoration of clinical audit to stimulate improvements in clinical practice and service delivery. It is therefore particularly timely that Solent NHS Trust is undertaking a review of its service evaluation and clinical audit activity and it is suggested that as the challenges faced are similar for both, the co-ordination of their development and improvement be delivered in tandem. A more strategic and organised approached to clinical audit across all the services is the Trust is critical to the bid for Foundation Trust Status, national reporting requirements, the expectations of commissioners and revalidation. 7. Key strategic goal 6: Embrace a culture of patient and the public involvement in research, evaluation and clinical audit Patient and public involvement is a vital part of research, evaluation, clinical audit and service improvement and will be a key tenet of the evidence based practice culture at Solent NHS Trust. Research, Service Evaluation & Clinical Audit Plan v7 12

User involvement ensures that work is: useful, relevant and of high quality; it helps us to ensure equality and diversity in participant recruitment, particularly in accessing harder to reach communities; it helps to ensure that findings are published and communicated in ways that are appropriate and accessible for the participants and target audiences. User and public involvement is now a necessity for the granting of many funding opportunities and for approval by Research Ethics Committees. Increased involvement will be delivered via: a. Partnership with the Research Design Service, INVOLVE and HQIP b. Lay membership on the R&D Committee & representation at the annual conference c. Tightening up governance processes to include PPI d. Guidance on the website and support for lay members and researchers e. Dovetailing with Trust membership and public engagement events 8. Intellectual Property The Trust recognises that innovation may occur as a result of participating in Research & Development activities, and as such, will act to exploit opportunities for innovation in its research partnerships. In this regard it also seeks to encourage and support staff to participate in the generation of Intellectual Property (IP) as part of its commitment to encourage innovative practice and to deliver excellent healthcare. In such cases, staff should refer to the Intellectual Property Policy. Research, Service Evaluation & Clinical Audit Plan v7 13

Appendix 1: Glossary CIP CLRN CQC CRN CRO DH e-dge ETCs GMC H&IOW CLRN IG IP IRAS NIHR Non-PF NRES PCRN PF PIC PPI R&D RDS RM&G SLA SOP SSCs Cost Improvement Plan Comprehensive Local Research Network Care Quality Commission Clinical Research Network Clinical Research Organisation Department of Health Online database system for research management Excess Treatment Costs General Medical Council Hampshire and IOW Comprehensive Local Research Network Information Governance Intellectual Property Integrated Research Application System National Institute for Health Research Non-portfolio National Research Ethics Service Primary Care Research Network Portfolio Participant Identification Centre Patient and Public Involvement Research and Development Research Design Service Research Management and Governance Service Level Agreement Standard Operating Procedure Service Support Costs Research, Service Evaluation & Clinical Audit Plan v7 14

Appendix 2: Defining Research, Service Evaluation & Clinical Audit Research Service Evaluation Clinical Audit The attempt to derive generalizable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them. Designed and conducted solely to define or judge current care Designed and conducted to produce information to inform delivery of best care Quantitative research designed to test a hypothesis Qualitative research identifies/ explores themes following established methodology Designed to answer: What standard does this service achieve? Designed to answer: Does this service reach a predetermined standard? Addresses clearly defined questions, aims and objectives Measures current service without reference to a standard Measures against a standard Quantitative research may involve evaluating or comparing interventions, particularly new ones Qualitative research usually involves studying how interventions and relationships are experienced Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care. Usually involves analysis of existing data but may include administration of interview or questionnaire. Usually involves analysis of existing data but may include administration of interview or questionnaire. Source: National Patient Safety Agency Research Ethics Service: Defining Research leaflet Research, Service Evaluation & Clinical Audit Plan v7 15

Appendix 3 The Policy Framework The policy framework driving the need for a strengthened evidence base include: The NHS Operating Framework, in 2010/11, demand(ed) radical approaches and innovation.. to realise the transformation necessary to improve the quality of services to patients at the same time as reducing costs, and in 2011/12 maintained that the core purpose remains the delivery of improved quality for our patients, by improving safety, effectiveness and patient experience Continued research and the use of research evidence in design and delivery of services is key to achieving improvements in outcomes. The 2010 White Paper, Equity and Excellence: Liberating the NHS which outlines a vision for the NHS in which there is a focus on implementing best practice to achieve improvements in outcomes supported by continued research, and an emphasis on evidence based medicine and policy making, within a culture of evaluation and learning. The paper goes on to stress the importance of research in the development and implementation of quality standards, noting that, Research is vital in providing the new knowledge needed to improve health outcomes and reduce inequalities" and asserting research as a core NHS role.. The Quality Outcomes Framework, which makes measurement of outcomes and an evidence base to demonstrate improvement to these outcomes mandatory for NHS Trusts. The Quality, Innovation, Productivity and Prevention programme which sit a at the centre of the transformation of the NHS, improving the quality of care whilst making significant efficiency saving. Within this it advises that it is crucial that best practice, innovative ways of working and new technologies are not only identified and adopted locally; but are shared and spread across the NHS Monitor: At the heart of the Foundation Trust philosophy is improved quality of are through innovation and the adoption of better practices. This includes learning from local and international evidence Guidelines on Delivering Sustainable Cost Improvement Programmes, which identifies a key factor in the ability to deliver to be realistic evidence based schemes with clear success measures for improved services. Solent NHS Trust supports the Department of Health s objective, within the Transforming Community Services Agenda to create:.modern, innovative community and mental health services that have direct benefits for patients, are responsive to local need, and promote seamless care through increased opportunities for integration of health and social care services Solent NHS Trust has entered the pipeline to apply for Foundation Trust Status. It s stated mission is to work in partnership to deliver health and local care and its vision is to lead the way in local care. These are supported by seven core values which are to be Involved, Nurturing, Striving for Excellence, Passionate, Innovative, Empowered and Respectful. Research, Service Evaluation & Clinical Audit Plan v7 16

Appendix 4: Key Performance Indicators, Research Accountable to Measure Assessment Criteria (to be used at year-end) Supporting information & source 1 Increase in patients participating in all studies Trust Board Patients recruited to all studies against target : 10% increase p.a Meet or exceed target 90-99% of target <90% of target Monthly activity reports via edge and tracker Increase in patients recruited into NIHR CRN Portfolio Studies H&IOW CLRN Trust Board Patients recruited to CRN studies against target: negotiated annually. 2012/13 = 250 Meet or exceed target 90-99% of target <90% of target Monthly activity reports via edge and tracker/ CLRN reports 2 To increase the number of recruiting studies Trust Board Number of studies active against target (..) Meet or exceed target 75-99% of target <75% of target Quarterly reports 3 To increase the number of commercial studies Trust Board Number of new contracts against target (2 studies 2012/13) Meet or exceed target 80-99% of target <80% of target Quarterly reports To increase the number of commercial studies on the NIHR CRN portfolio H&IOW CLRN Trust Board Number of new contracts against target (1 study 2012/13) Meet or exceed target 80-99% of target <80% of target Quarterly reports 4 Proportion of sites recruiting to target (Commercial) Trust Board % of commercial study sites recruiting to target 90% 70-89% <70% of target Monthly activity reports via edge and tracker/ CLRN Proportion of sites recruiting to target (NIHR CRN portfolio studies) Trust Board H&IOW CLRN % of portfolio study sites recruiting to target 80% 70-79% <70% of target Monthly activity reports via edge and tracker/ CLRN 5 % studies receiving NHS permission letter within 30 days of receipt of valid document pack Trust Board H&IOW CLRN % studies receiving NHS permission letter within 30 days of receipt of valid document pack 80% 70-79% <70% of target Monthly activity reports via tracker Research, Service Evaluation & Clinical Audit Plan v7 17

References Academy of Medical Sciences (2011) A New Pathway for the Regulation and Governance of Health Research Audit Commission/ Monitor (2012) Delivering Sustainable Cost Improvement Programmes http://www.monitor-nhsft.gov.uk/home/news-events-and-publications/our-publications/browse-category/developing-foundation-trusts/deli DH (2010) Equity and Excellence, Liberating the NHS (White Paper) http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_117353 DH/ NHS Finance, Performance and Operations (2010) The Operating Framework for the NHS in England 2011/12 http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_122738 DH (2010) The NHS Constitution for England (2009 Edition) http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_113613 DH/ NHS Finance, Performance and Operations (2010) Revision to the Operating Framework for the NHS in England 2010/11http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_110107 DH (2009) Transforming Community Services: Enabling New Patterns of Provision http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_093197 DH (2009) NHS 2010-15: From Good to Great. Preventative, People-Centred, Productive http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_109876 DH/ NHS Finance, Performance and Operations (2008) The Operating Framework for 2009/10 for the NHS in Englandhttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_091446 DH (2006) Best Research for Best Health: A New National Health Research Strategy http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_4127127 DH (2005) Research Governance Framework for Health and Social Care, 2 nd Edition http://www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_4108962 HM Treasury (2010) Spending Review 2010 http://cdn.hm-treasury.gov.uk/sr2010_completereport.pdf GMC (2011) Revalidation of Doctors NHS Portsmouth, Clinical Commissioning Group (2012) Portsmouth Clinical Commissioning Group: Principles of Business and Provider Management Research, Service Evaluation & Clinical Audit Plan v7 18

Solent NHS Trust (2012) A report of a review of Solent NHS Trust s clinical audit systems and processes (internal report written by Carol Bailey) Solent NHS Trust (2011) Strategy for Quality Improvement 2011-16 Research, Service Evaluation & Clinical Audit Plan v7 19