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NICOR:

The National Institute for Cardiovascular Outcomes Research

STRATEGY and BUSINESS PLAN


August 2011
NICOR at the Institute of Cardiovascular Science, University College London.

Contents
1 2 3 Summary ............................................................................................................. 3 Mission statement ............................................................................................... 5 Context ................................................................................................................ 6 3.1 3.2 3.3 3.4 3.5 4 4.1 4.2 5 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 8 9 What is NICOR?............................................................................................ 6 A national cardiac registry, clinical audit and outcomes system .................... 7 Remit ........................................................................................................... 10 Policy and legislative framework ................................................................. 12 Preparing for the first year ........................................................................... 14 Purpose, aim and objectives ....................................................................... 15 Core activities and enabling wider benefits ................................................. 16 Board and Executive ................................................................................... 19 Role of the specialist societies .................................................................... 20 Committee structure .................................................................................... 20 Terms of reference (TOR) and policies........................................................ 22 Information governance .............................................................................. 23 Involving patients in our work ...................................................................... 25 The quality of our work ................................................................................ 26 Principles .................................................................................................... 27 The scope of NICORs work ........................................................................ 29 Quality improvement ................................................................................... 30 Research use of national audit data ............................................................ 33 Revalidation ................................................................................................ 36 Human resources ........................................................................................ 37 Accommodation .......................................................................................... 38 IT ................................................................................................................. 38 Finance ....................................................................................................... 39 2011/12 ....................................................................................................... 40 Communications ......................................................................................... 40 Risk management ....................................................................................... 41

Strategic direction.............................................................................................. 15

Governance ...................................................................................................... 19

The work NICOR plans to do ............................................................................ 29

Infrastructure ..................................................................................................... 37

Summary action plan ........................................................................................ 43 Annexes ............................................................................................................ 46 9.1 Abbreviations .............................................................................................. 46

References ............................................................................................................... 47

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1 SUMMARY
NICOR (the National Institute for Cardiovascular Outcomes Research) is part of the Centre for Cardiovascular Prevention and Outcomes at University College London. We are a unique partnership of clinicians (from local hospitals, the national specialist societies and DH), IT experts, analysts, academics and managers. NICOR enables clinicians to take a leading, central part in the NHS information revolution. Our mission is to provide information to improve heart disease patients quality of care and outcomes. NICOR collects patient information from UK hospitals into secure cardiovascular registries established by the specialist clinical societies. We then help the NHS, the government and regulatory bodies improve quality by checking that care meets good practice standards through clinical audit, and by comparing outcomes such as casemix-adjusted survival rates. Our reports and online public portals help patients make choices, and build public confidence in NHS cardiac care. NICOR encourages research using real world data to complement and refine the lessons learnt from randomised clinical trials. This document sets out our longer-term strategy and details what we will do during 2011/12. NICORs initial focus is to manage six national cardiovascular clinical audits and their associated registries:
Audit Adult cardiac surgery Cardiac interventions Cardiac rhythm management (CRM) Congenital heart disease Patients All adult patients undergoing major heart surgery. All adult patients on whom a percutaneous cardiovascular intervention procedure is performed. All adult patients with implanted devices or receiving interventional procedures for management of cardiac rhythm disorders. All cardiac or intrathoracic great vessel procedures carried out in patients under the age of 16 years, and all adult congenital cardiac procedures performed for a cardiac defect present from birth. All patients with an unscheduled admission to hospital with heart failure. All adult patients with acute coronary syndromes. All patients undergoing Transcatheter Aortic Valve Implantation Lead specialist society Society for Cardiothoracic Surgery (SCTS) British Cardiovascular Intervention Society (BCIS) Heart Rhythm UK (HRUK)

British Congenital Cardiac Association (BCCA)

Heart failure MINAP TAVI

British Society for Heart Failure (BSH) British Cardiovascular Society (BCS) BCIS and SCTS

NICOR has particularly close relationships with the specialist cardiovascular societies. They provide the clinical leadership for each registry and audit, and most of the original datasets were developed by them.
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The national cardiac audits fit well into the new NHS Outcomes Framework and can provide the type of information that the Government aims to introduce for the use of commissioners, providers, and patients. NICOR must handle sensitive, confidential information about individual patients in order to fulfil its purpose. Our system security arrangements meet Ethics and Confidentiality Committee requirements, and UCL has been granted approval under section 251 of the NHS Act 2006 to process patient audit data. NICOR starts with funding from the Department of Health (provided via a contract with HQIP) intended to cover the core costs of six national cardiac audits for three years. In addition we have received grants from the British Heart Foundation, the National Specialist Commissioners, the GA Moore Foundation and the Association of British Healthcare Industries (ABHI). In 2011/12 this totals 1.84m. NICOR intends over time to expand the range of cardiac care covered by national audits. To prepare for this we will be reviewing our methodology, including the IT systems which underpin our activities. During 2011/12 data hosting and first-line helpdesk facilities for local hospitals are provided under subcontract by the NHS Information Centre. We aim to take full control of all audit functions in the near future.

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2 MISSION STATEMENT

NICOR (the National Institute for Cardiovascular Outcomes Research) provides information to improve heart disease patients quality of care and outcomes. We are a unique partnership of clinicians (from local hospitals, the national specialist societies and DH), IT experts, analysts, academics and managers. We will: 1) Collect patient information from UK hospitals into secure cardiovascular registries established by specialist clinical societies. 2) Check that care meets good practice standards through clinical audit, and report on outcomes such as casemix-adjusted survival rates and patient experiences. 3) Support NHS quality improvement by providing feedback to hospitals, networks, commissioners, government departments and regulators. 4) Help patients make choices and provide public assurance via our reports and online public portals. 5) Encourage research using real world data to complement and refine the lessons learnt from randomised clinical trials. 6) Enable clinicians to take a leading, central part in the NHS information revolution. 7) Through measurement, improve and build public confidence in NHS cardiac care.

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3 CONTEXT
3.1 What is NICOR?

3.1.1 NICOR (the National Institute for Cardiovascular Outcomes Research) exists to improve the care and outcomes of patients with cardiovascular disease by providing high quality comparative information. Established by Sir Bruce Keogh, now NHS Medical Director, NICOR is led by Professor Sir Roger Boyle and Professor John Deanfield, in association with the specialist clinical societies responsible for each of the national audits. 3.1.2 Clinicians lead the audits, working together with information management experts. The audits have many partners (as described further below) but in particular there is a close relationship with local hospitals which submit data to the registries and receive in return comparative audit reports. NICOR sits within the Centre for Cardiovascular Prevention and Outcomes Centre (CCPO), which is in turn part of the Institute of Cardiovascular Science at University College London (UCL) - Figure 1. Figure 1 NICORs position within UCL, and its main partners
Sponsors: DH Heart Disease & Stroke Specialist cardiovascular clinical societies Partners: Hospital trusts and commissioners Specialist societies & royal colleges Patients organisations and CQC Funders: DH via NCAAG and HQIP National Specialist Commissioners BHF, ABHI, GA Moore Foundation UCL Partners UCL School of Life & Medical Sciences Faculty of Biomedical Sciences Institute of Cardiovascular Science

CCPO: Centre for Cardiovascular Prevention & Outcomes

NICOR: National Institute for Cardiovascular Outcomes Research NICOR Executive Audit/registry committee Academic committee Management team

CCPO Board

Audit & Outcomes

Prevention

Policy & Economics

3.1.3 Currently most of NICORs funding comes from the Healthcare Quality Improvement Partnership (HQIP), acting for the Department of Health and its
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National Clinical Audit Advisory Group (NCAAG). NICOR also receives funding from the British Heart Foundation (BHF), the National Specialist Commissioners, the GA Moore Foundation and the Association of British Healthcare Industries (ABHI). The funding awarded by HQIP covers the period from 1 April 2011 to 31 March 2014. This document sets out our strategy for the next five years and our business plan for the first year (Figure 2). Figure 2: The period covered by this document

3.2

A national cardiac registry, clinical audit and outcomes system

3.2.1 NICOR works at every level across the country, from individual acute hospitals; through ambulance services, cardiac networks, commissioners and SHAs; to the national level. The main partners that work with NICOR are summarised in Box 1. 3.2.2 NICOR provides its NHS partners with clinical audit and outcome feedback to help them monitor and plan how to improve the quality of care for patients with cardiovascular conditions. The national registries are part of a sophisticated IT-based system that links data entry from every acute hospital with a secure central database (the Central Cardiac Audit Database CCAD). Online reports are provided for participating hospitals that compare their performance with others and against good practice standards. There is a strong emphasis on data checking and quality at all levels and, where possible, on risk-adjusting analyses to ensure that we compare like with like making the outputs more accurate and clinically relevant than that available from routine systems such as the Hospital Episode System (HES). Both professional and public reports are produced. Outputs are also provided for regulatory bodies (eg, the Care Quality Commission (CQC) and the Medicines and Healthcare products Regulatory Agency (MHRA)), for patients and the public via public portals and NHS Choices, and for government departments. NICOR also
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encourages appropriate research use of this real world information to inform clinical practice by complementing and refining the lessons learnt from randomised clinical trial data. Box 1: NICORs partners
Sponsors National Clinical Director for Heart Disease & Stroke, and the DH Vascular Programme. Specialist clinical societies.

Governance NICOR Board and Executive (external members include the NHS Medical Director and patient representative). Each registry has its own board or steering group including multidisciplinary and patient representation. Academic Groups release data for research to those meeting explicit criteria. Funders HQIP, the British Heart Foundation National Specialist Commissioners, GA Moore Foundation, Association of British Healthcare Industries (ABHI) (EMSCG). Clinical leads from specialist professional societies lead each audit. NICOR staff provide advice and support to local users and the clinical lead, analyse the data and produce reports. The Advanced Information Systems Centre at UCL runs the main Central Cardiac Audit Database system (CCAD). Commercial and local data entry systems interface with the main system. Local members of the specialist clinical societies, and other members of the multidisciplinary team, submit data and use the feedback. NHS Trusts enable clinicians to participate. The IT and staff costs of taking part are met by local Trusts. Cardiac networks, commissioners and SHAs use the findings. CQC, MHRA and NPSA use the findings during their assessment, inspection and registration activities. DH for the NHS Operating Framework, and other users such as NHS Choices. Researchers seeking access to the audit data. Patients can directly use information via the two public portals that currently exist, public reports and through NHS Choices, to inform themselves and help make decisions about their care.

Providers of the system

Clinical leadership and support IT service providers

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Users of the findings

Local users

Regulators Other nationallevel users Patients and the public

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3.2.3 NICOR has four main groupings of partners directly involved in using its national system and outputs (Figure 3), with overall governance of the system provided via the NICOR Board and Executive: Local participants: Local clinicians input data and use the comparative feedback to review their clinical practice. Trust boards can use the findings to review the quality of care, and report on audit participation in their Quality Accounts. The design of the audits seeks to reduce the local costs of participation as far as possible. For example, the Adult Cardiac Surgery Audit estimates that the average surgeon might take 40 minutes per week to record the necessary data, anticipating that this time cost might be covered from the 6-10 hours per week set aside for supporting professional activities (SPAs) within most consultant contracts (Bridgewater, Cooper et al. 2011). NHS Trusts meet the costs of local IT interface and any extra staff costs involved in collecting and entering data. The level of local costs will vary for each audit, but in the case of Adult Cardiac Surgery have been estimated at 0.7% of the service cost (Bridgewater, Cooper et al. 2011).

Figure 3: NICORs national system and the partners involved

NICOR Board & Executive Governance


Local hospitals: Collect & input data Check data quality (DQ) Use reports

Data entry

Central Cardiac Audit Database (CCAD) within the Advanced Information Services Centre (AISC), UCL: System maintenance & back-up Link to other datasets Views & System security reports Dataset changes Error checks Software fixes Development Secure

repository

NHS IC: Data hosting Helpdesk

External organisations: Specialist societies CQC, MHRA (regulation) Cardiac Networks Data extracts, Commissioners, SHAs reports, NHS Choices public portals Research groups

Clinical leads & NICOR support staff: Public & professional reports Coordination, advice Risk adjustment Analysis DQ audit, validating & cleaning Local user workshops, newsletters Facilitating and regulating research access .

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Audit leadership and support: Clinicians nominated by the relevant specialist societies lead each registry and audit. NICOR staff offer advice and support to local participants, helping to share good practice in data entry and in using the feedback to improve patient care. We carry out analyses on the datasets and produce reports for external users. External users: A wide range of partners make use of the analyses and reports, including healthcare regulators, the DH, researchers, patients and the public. Cardiac networks, commissioners and strategic health authorities (SHAs) also use the aggregated outputs. IT infrastructure: The system is under-pinned by the Central Cardiac Audit Database (CCAD) managed via the Advanced Information Systems Centre (AISC) of our host organisation, UCL. Specialist staff provide programming support for the individual audits. AISC provides an interface into CCAD for the many variants of local data entry systems that exist. System security meets the requirements of the Ethics and Confidentiality Committee (ECC) of the National Information Governance Board (NIGB), which has granted UCL approval under section 251 of the NHS Act 2006 to process patient audit data (further details on information governance arrangements are given later). Remit

3.3

3.3.1 NICORs initial focus is to manage six national cardiovascular clinical audits and their associated registries (a special initiative involving the adult surgery and interventions audits records TAVI, which can be thought of as our seventh audit). NICOR has particularly close relationships with the specialist cardiovascular societies (Table 1). The specialist societies provide the clinical leadership for each registry and audit, and most of the original datasets were developed by them. Table 1 National clinical audits for which NICOR has responsibility from 2011
Audit Adult cardiac surgery Cardiac interventions Cardiac rhythm management (CRM) Congenital heart disease Patients All adult patients undergoing major heart surgery. All adult patients on whom a percutaneous cardiovascular intervention procedure is performed. All adult patients with implanted devices or receiving interventional procedures for management of cardiac rhythm disorders. All cardiac or intrathoracic great vessel procedures carried out in patients under the age of 16 years, and all adult congenital cardiac procedures performed for a cardiac defect present from birth. Lead specialist society Society for Cardiothoracic Surgery (SCTS) British Cardiovascular Intervention Society (BCIS) Heart Rhythm UK (HRUK)

British Congenital Cardiac Association (BCCA)

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Audit Heart failure MINAP TAVI

Patients All patients with an unscheduled admission to hospital with heart failure. All adult patients with acute coronary syndromes. All patients undergoing Transcatheter Aortic Valve Implantation

Lead specialist society British Society for Heart Failure (BSH) British Cardiovascular Society (BCS) BCIS and SCTS

Some of the audits have the close involvement of more than one specialist society. The full list of partners involved in the governance of each audit can be found via NICOR, specialist society and audit websites and reports.

3.3.2 NICOR focuses on three different, but closely related, quality improvement techniques that involve the systematic review of healthcare: outcomes analysis, clinical audit against standards, and original research. 3.3.3 The first two activities are funded via NICORs core funding. Research activity is funded separately and is not carried out by NICOR itself, which makes the data available to applicants meeting explicit criteria. Our activities fit closely with the NCAAG advice that Clinical audit is the assessment of the process (using evidencebased criteria) and/or the outcome of care (by comparison with others). Its aim is to stimulate and support national and local quality improvement interventions and, through re-auditing, to assess the impact of such interventions (National Clinical Audit Advisory Group 2009). 3.3.4 Clinical audit and outcomes measurement are closely related activities that can help to close the gap between what is known to be best care and the care that patients are actually receiving now. The NHS cannot improve unless it knows how patients are treated (by carrying out clinical audit) and if that treatment has worked (by measuring outcomes). NICORs work aims to help in ensuring that all patients receive the most effective, up to date and appropriate treatment, delivered by clinicians with the right skills and experience, resulting in the best possible outcomes issues of vital importance to patients and those who treat them (Box 2). Box 2: The most important questions Clinical audit and outcomes measurement can answer the key questions that patients and clinicians ask: Patients: Clinicians: Answered by: Was I given the best care? Has my health improved? Do I feel better? Did I do the right things? Am I helping to improve survival and reduce morbidity? Am I helping to reduce the burden of disease? Clinical audit against good practice criteria or standards. Clinical outcomes measurement. Patients reported outcomes, eg, quality-of-life measures.

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3.4

Policy and legislative framework

3.4.1 The DHs Transparency in outcomes - a framework for the NHS - Government response to the consultation (December 2010) emphasises the role of measurement and audit in improving patient care. The Government has concluded that Patient Reported Outcome Measures (PROMs), other outcome measures, patient experience surveys and national clinical audit are not used widely enough. We will expand their validity, collection and use. The Department will extend national clinical audit to support clinicians across a much wider range of treatments and conditions (Equity and excellence: Liberating the NHS. White paper, Dept of Health, July 2010). 3.4.2 The national cardiac audits thus fit well into this new NHS Outcomes Framework and can provide the type of information that the Government aims to introduce for the use of commissioners, providers, and patients. As one of our clinical leads has noted, the development of new [clinical or performance] indicators involves the translation of scientifically proved interventions into explicit measurable items of care within well-defined groups of patients. This process requires credibility amongst clinicians and managers in order to promote collection and transmission of appropriate data (Weston 2008). Indicators that the DH wishes to develop as part of the new Outcomes Framework will need just such credibility, and the national cardiac audits, (eg, by the relevant specialist clinical societies and delivering large scale databases) can provide it. 3.4.3 Information for patient choice is already provided via two public portals (see elsewhere in this document for the details). NICOR and the specialist societies are thus already delivering the kind of work described by the DHs An Information Revolution: a consultation on proposals, one of a series of documents published subsequent to the White Paper: It is part of the Governments agenda to create a revolution for patients putting patients first - giving people more information and control and greater choice about their care. The information revolution is about transforming the way information is accessed, collected, analysed, and used so that people are at the heart of health and adult social care services (http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_120080). 3.4.4 The Outcomes Framework proposes introducing outcome measures under five domains. NICOR is evaluating how each NICOR audit may be used, but Table 2 uses the Cardiac Rhythm Management Audit (CRM) as a preliminary example. 3.4.5 Participation in the national audits has in the past been essentially voluntary.1 However, there are requirements on NHS organisations and individual clinicians that encourage participation, including:

Since 1989 participation in clinical audit has been mandatory for individual doctors. However, the choice of topic and whether this is locally or nationally organised is not prescribed.

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Since April 2011 NHS terms and conditions state: Clause 12.1 The Provider shall...participate in the national clinical audits within the National Clinical Audit Patients Outcome Programme (NCAPOP) relevant to the services (2011/12 Standard Terms and Conditions for Acute Hospital Services, Gateway Reference 15458). NHS provider organisations must report on participation in four of the six audits that NICOR provides in their 2010/11 Quality Accounts. Information about selected standards of care and national audit data quality is provided on request to the Care Quality Commission (CQC). The exact nature of what CQC uses in its regulatory assessments of NHS organisations varies each year. A new system for collecting subscription payments from NHS trusts for national clinical audits is being piloted. Best Practice Tariff payments (BPTs) have been added to the Payment By Results (PBR) system from April 2010. Although initially there are no BPTs directly related to NICORs cardiac audit datasets, there are two in another cardiovascular disease. Acute trusts able to demonstrate that they met two standards in the care of each individual stroke patient are eligible for payment equivalent to an extra 12% on top of the base tariff. For emergency stroke admissions the extra payment is 133 for rapid CT scan and 342 for direct admission and 90% of spell spent in an acute stroke unit. An NHS trust can only realistically provide evidence that these standards have been achieved by taking part in national stroke audits. Should this aspect of PBR be extended to cardiac care, there will be a strong incentive for trusts to take part in the national audits.

Table 2: NICOR audits and the NHS Outcomes Framework: example of the Cardiac Rhythm Management audit (CRM)
The proposed domain: 1) Preventing people from dying prematurely. 2) Enhancing quality of life for people with long-term conditions. 3) Helping people to recover from episodes of ill health or following injury. 4) Ensuring that people have a positive experience of care. 5) Treating and caring for people in a safe environment and protecting them from avoidable harm. What CRM can offer: CRM reports on inequity in provision of devices that prolong life, and on long-term survival rates. Working with the other audits, we plan to develop patient-reported outcomes measures. The clinical focus on follow up of patients with implanted devices is recorded by CRM, including any complications. The potential exists to link CRM patient records with other datasets recording patient satisfaction. CRM records the safety of treatment, including protection from device harm near the end of life.

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3.5

Preparing for the first year

3.5.1 NICOR became responsible for delivering six national cardiac audits from 1 April 2011. Preparing for this was a major challenge. The main elements that needed to be in place before 1 April were: Agree the wording, deliverables and costs for the main contract between HQIP and NICOR/UCL. The contract runs from 1 April 2011 to 31 March 2014 at a cost of 5.268 million. Agree the wording, service specification and costs for the subcontract between NICOR/UCL (University College London) and the NHS Information Centre for the provision of data hosting and helpdesk services. The contract runs from 1 April 2011 to 31 March 2012 at a cost of 230,971 + VAT (total 277,165). Apply for and achieve S251 approval from the Ethics and Confidentiality Committee to process confidential information. Secure accommodation for staff, furnished and with IT and telephones in place. Carry out the process to transfer CCAD staff from the NHS IC to UCL under the Transfer of Undertakings (TUPE) process.

3.5.2 For 2011/12 the NHS IC continues to provide a data hosting and frontline technical helpdesk function to local trusts. The same CCAD staff continue to provide the audit service. UCL and the NHS Information Centre (IC) are working closely together to minimise any risk of service disruption introduced by the new arrangements.

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4 STRATEGIC DIRECTION
4.1 Purpose, aim and objectives

4.1.1 NICOR helps improve the care and outcomes of patients with cardiovascular disease by delivering national clinical audits. To achieve our mission (as set out at the beginning of this document) NICOR staff will aim to provide the best possible support to the clinicians leading our audits. NICOR will: Employ high quality staff to support the clinical leads with hospital liaison, data checking, analysis and reporting. Ensure the IT platform is secure, reliable and fit for purpose. Help each audit to achieve its aims, with the highest methodological quality. Establish NICOR as a centre of excellence that others wish to work with and fund.

4.1.2 In more detail, NICORs objectives are to: Identify the outcome of care: We link audit information to the date of any subsequent deaths to identify how long patients survive after treatment. We also look at other indicators such as re-admissions to hospital. Check whether the best care is delivered: We look at key process indicators, such as whether heart attack treatment is given quickly enough. Reduce inequity: We compare performance, where meaningful, by ethnicity, age, gender, deprivation, hospital and individual operator. Compare like with like: NICOR demands good data quality from its contributing hospitals, and helps them audit their systems to ensure this can be achieved. Wherever possible, we use sophisticated casemix-adjustment to ensure the true picture is revealed in a way that standard data systems such as HES are unable to do. Assure patients: Our reporting systems help to reassure the public that most hospitals provide safe and effective care most of the time. For example, our information is fed into public portals which patients and the public can use to check and compare outcomes of heart surgery and congenital heart disease care at their local hospitals. Information is also provided for NHS Choices. Promote improvement: When results are not as they should be, we help clinicians and managers to identify where improvements need to be made. Link care across the patient pathway: NICOR is well placed to promote patientfocussed care for those with cardiovascular disease. Each individual audit looks at whether the care given at a particular time met best quality standards and led to the best possible outcome. But NICORs umbrella responsibility for the audits
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means it could link different types of episode together and follow individual patients along the pathway of their care. Because of the importance of estimating the effect of all events on the patient, and on healthcare resources, it is crucial that the separate audits are linked together. Quality of life for an individual patient is not just whether they received good care after their heart attack or surgery, but also how much event free time they experience on their journey when living with heart disease. Enable research: NICOR encourages research use of the data, with a particular future intention to link information about individual patients disease and treatments across datasets to help identify not only how long they survive, but also what aspects of care work best and how well services are coordinated. NICOR, in conjunction with the specialist societies, authorises and enables additional research to be performed on the data.

1. Board and Executive to discuss and agree wording of NICORs purpose, aim and objectives. Lead responsible: Board and Executive. Due: September 2011. 4.2 Core activities and enabling wider benefits

4.2.1 To achieve its objectives, NICOR must carry out a variety of activities. Some of these activities focus on supporting the specialist societies that lead each audit and their clinician members in the local hospitals that submit data. Others are necessary to meet the wider demands put upon NICOR in return for public funding. In essence NICORs main functions are to manage an IT-based system that collects and securely stores patient-level data, performs analyses and provides feedback to local NHS and national bodies such as the National Commissioning Board, DH and the Care Quality Commission, and all within the resources available. There are other activities that NICOR could carry out, or liaise with others to help them carry out, that can make further use of the audit data to increase its benefit to patients (Table 3). Table 3: Core activities of NICOR, and functions it could perform with extra resourcing
Core activities are listed on a grey background; extra activities on white. System management and development 1. Manage a data collection system for hospitals to submit audit data about individual patients to central databases. 2. Check, and when necessary encourage hospitals to improve, data completeness and quality. 3. Provide technical and clinical helpdesk function to participating hospitals 4. Provide contributing hospitals with access to an online reporting facility that enables them to examine the quality of their care and outcomes compared with national aggregate data. 5. Implement system developments to support changes to the dataset required to keep up with changes in clinical practice. 6. Coordinate activities in support of the clinical lead (hospital liaison, contract management monitoring, proposal development, workshop arrangements, newsletters, etc).
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Core activities are listed on a grey background; extra activities on white. 7. Advise on information governance and liaise with the governmental body that provides special exemption to national clinical audits. 8. Make progress towards including appropriate patient-related outcomes measures (PROMs). 9. Carry out extensive system developments to support improvements in datasets. 10. Appraise the need for/carry out an update of the technical infrastructure to a new platform. Linkage 11. Link patient records to the NHS Central Register to monitor survival. 12. Link patient records across NICOR audits to track individual patients across pathways, calculating event-free survival and its determinants. 13. Link patient records to others datasets for specific purposes. Analysis and provision of data 14. Conduct comparative analyses: Outcomes, including casemix adjustment using existing methodology. Whether care meets the good practice standards adopted by the audit.

15. Provide basic comparative analyses to governmental bodies such as the National Commissioning Board, DH, NHS Choices, CQC and MHRA. 16. Develop performance indicators which assist in benchmarking of institutions, and identifying outliers. 17. Provide cleaned defined datasets to external research groups. 18. Conduct specific analyses for the specialist society leading the audit. 19. Conduct specific analyses for local NHS bodies. 20. Develop risk models and apply new casemix methodology 21. Provide non-standard analyses and/or data to national bodies such as the National Commissioning Board, DH, CQC and MHRA. 22. Make available validated single institution and practitioner data which will assist individual revalidation. 23. Provide analyses or data to non-governmental bodies for non-academic purposes. 24. Provide analyses for informing NICE guidance Feedback and reporting 25. Feedback basic comparative reports to local NHS bodies. 26. Deliver annual reports providing and interpreting timely, basic comparative analyses: For members of the specialist society (the professional report). In plain language for a wider audience, including the general public.

27. Maintain a website providing relevant information and outputs from each audit for clinicians, stakeholders and the wider public 28. Produce special request reports. 29. Provide or collaborate with interactive public portals providing information to patients about the performance of their local hospital.

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Core activities are listed on a grey background; extra activities on white. New audits 30. Pursue appropriate sources of funding and consider undertaking new externally commissioned, fully-funded, projects. 31. Develop new datasets and advise ISB on classification of new devices/technologies. 32. Provide new audits. Fostering improvement 33. Provide workshops for hospitals submitting data to share good practice in how to improve patient care following audit. 34. Educate/train others in the how to carry out health outcomes research.

2. Agree details of what is core audit work and what is extra work for which NICOR should pursue funding. Lead responsible: Executive. Due: August 2011.

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5 GOVERNANCE
5.1.1 As described in Chapter 1, NICORs line of accountability is to the Board of UCL, and for contract delivery it is accountable to the DH via HQIP. 5.2 Board and Executive

5.2.1 Currently NICOR is governed by a Board and an Executive. NICOR is part of a wider grouping within UCL, linked with colleagues working in prevention and economics, forming the Centre for Cardiovascular Prevention and Outcomes (CCPO). It is the longer-term intention to have an over-arching Board for CCPO to which NICOR would be accountable. CCPO has two co-Directors Professor John Deanfield and Professor Sir Roger Boyle (who is the Chair of the NICOR Executive). The HQIP core funding is ring-fenced within NICOR and has its own budget code. Currently the NICOR/CCPO Board membership is: Board Chair: National Clinical Director for Heart Disease & Stroke (also holder of a UCL post) Co-director of CCPO (and Deputy Cardiovascular Program Director for UCL Partners) Chair of UCL Partners NHS Medical Director Chair of Information Standards Board Past president of Heart Care Partnership UK (patient group representative) Members of the NICOR Executive (see below)

5.2.2 Currently the NICOR Executive membership is: Executive Chair: National Clinical Director for Heart Disease & Stroke (also holder of a UCL post) Clinical Audit Leads of the six specialist societies: British Cardiovascular Intervention Society (BCIS) British Cardiovascular Society (BCS) British Congenital Cardiac Association (BCCA) British Society for Heart Failure (BSH) Heart Rhythm UK (HRUK) Society for Cardiothoracic Surgery (SCTS) CO-Director of CCPO Senior CCAD and NICOR management UCL Department of Epidemiology and Public Health

5.2.3 Initially we will continue with monthly Executive meetings, and biannual Board meetings. However, proposals for the membership, meeting frequency and decisionmaking arrangements in the longer-term will be put to the Board and Executive.

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3. Review Board and Executive membership and meeting frequency. Lead responsible: Board and Executive. Due: October 2011. 5.3 Role of the specialist societies

5.3.1 NICOR is also accountable to the specialist clinical societies that originally developed the audit datasets and which provide clinical leadership. Each of the clinical audit leads represents their audit and the professional society on the NICOR Executive and Board. NICORs structure is intended to strengthen the clinical leadership of the individual audits and provide tailored support to the clinical leads. The clinical leads liaise with the relevant clinical groups to ensure professional buy in, and provide the knowledge and experience of their clinical area to interpret the data and ensure that the analyses and reports address the most important issues. 5.3.2 The responsibilities of the specialist society/audit lead include specifying analysis criteria, revision of datasets, content and format of annual reports, reviewing applications for access to data by external research groups, ensuring there is a mechanism for the identification of outliers, future strategy and development of each audit, and defining and prioritising the research questions required by the specialist society. The audit leads are responsible for leading the delivery of the audits as required by the HQIP contract. They will be supported by the NICOR management team and the AISC IT delivery and development team. 5.4 Committee structure

5.4.1 Detailed discussions about the best committee structure for NICOR have yet to take place. In addition to a board or steering group for each audit, NICOR will need to develop certain shared committees (Table 4). In the longer-term it may make sense to develop shared supporting committees across CCPO and, if these establish successfully, then the NICOR-only committees may naturally choose to align with these (Figure 4). 4. Proposals for the longer-term governance structure of NICOR to be put to the Board and Executive. Lead responsible: COO. Due: September 2011. 5.4.2 Initially NICOR will either have an umbrella Academic Committee, or one for each audit, perhaps based on the current MINAP Academic Group (MAG) model. The MAG, established in 2005, has developed a policy which sets out the governance framework within which the MINAP data can be shared with third party research groups in a secure manner to ensure compliance with legal requirements and NHS standards. Researchers are required to submit a detailed proposal, including the study question, specific research objectives, and the proposed analyses and data requirements. Researchers must agree to the terms and conditions of use of data as set out in the Data User Agreement.

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Table 4: Initial proposals for NICOR governance arrangements


Body Overarching: NICOR Board NICOR Executive NICOR Management Team NICOR & CCAD Staff Forum CCPO Development Group CCPO Research Group NICOR Committees: Academic Audit Patients & Communications Delivery Estates Finance & Funding HR IT Policy & Governance Strategy Audit Liaison Groups: Cardiac Surgery CRM Interventions Congenital Heart Failure MINAP TAVI Audit Steering Groups: Cardiac Surgery CRM Interventions Congenital Heart Failure MINAP TAVI Audit Academic Groups: MAG (MINAP Academic Group) Remit Strategic direction Main decision-making forum for clinical leads and staff Operational decisions Discuss issues of concern and interest to all staff Integrating NICOR into CCPO Maximising opportunities for research use of audit data Governance for data sharing [may be unnecessary duplication of CCPO Research Group] Forum to discuss shared audit issues in more detail than Executive Patients' involvement, promoting NICOR, website, newsletter Performance monitoring against contract deliverables Accommodation, services Budget setting and management, identifying funding sources Recruitment, grading, etc SLA with AISC, technical issues, options after IC subcontract ends TORs, policies, management arrangements Scope of NICOR's work, bidding for new work Relationship and role of specialist society, clinical lead and NICOR As above As above As above As above As above As above As above Management of each audit As above As above As above As above As above As above As above Governance for MINAP data sharing, review applications for data

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Figure 4: Possible future committee structure for NICOR within CCPO

5.5

Terms of reference (TOR) and policies

5.5.1 NICOR will need to adopt a comprehensive set of policies and agree terms of reference for the Board, Executive and committees (Table 5). This will take time and must be in accord with established UCL policies where relevant. 5. Terms of reference (TOR) are required for the Board, Executive and each committee, once the NICOR structure is finalised. TORs must specify decisionmaking arrangements and lines of accountability. Lead responsible: committee chair. Due: within 4 weeks of committee being established. 6. A full set of necessary policies is required. Lead responsible: COO. Due: draft within 4 weeks of a necessary issue being identified.

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Table 5: List of NICOR terms or reference (TORs) and policies TORs CCPO Board NICOR Other committees Policy HR Notes Drafted 8/12/10. Not yet agreed. Drafted 12/5/09. None yet drafted. Notes NICOR will be bound by UCL policies, such as travel and subsistence, recruitment, appraisal. Some terms & conditions resulting from TUPE transfer are protected. Most of the requirements are outlined in the ECC application, and associated documents, and in the ECC response to the application. A process is required for identifying when performance is potentially so damaging to patients that NICOR could be deemed negligent (ethically so, even if not in law) if it did not alert those accountable for the healthcare being delivered. Guidance already in existence (eg, issued by the SCTS, and NCAAG/HQIP guidance Detection and management of outliers) will be considered when developing NICOR policy. TBC

Handling confidential information Acting when dangerous performance is identified.

Other issues

5.6

Information governance

5.6.1 NICOR must handle sensitive, confidential information about individual patients in order to fulfil its purpose. Section 251 of the NHS Act 2006 allows the common law duty of confidentiality to be set aside in specific circumstances in the interests of improving patient care or in the wider public interest, where anonymised information is not sufficient and where patient consent is not practicable. Organisations must apply to the Ethics and Confidentiality Committee (ECC) of the National Information Governance Board for Health and Social Care (NIGB) that recommends exemptions to the Secretary of State. 5.6.2 Our system security arrangements have met ECC/NIGB requirements, and UCL has been granted approval under section 251 of the NHS Act 2006 to process

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patient audit data.2 Our application explained our need to process identifiable information in order to: Trace pathways of care for individual patients by the collation of data from multiple sources over long periods of time. To track patients across organisations, as they move from clinic to clinic and hospital to hospital, or from general practice to hospital care and back again into the community, it is essential that all information related to an individual is appropriately linked. This requires a unique patient identifier so that further treatment episodes (including re-interventions, an important quality indicator) are tracked. Calculate how long patients live after different kinds of treatment, allowing clinicians and managers to identify how to improve care for patients. To do this the audits need to link their information with information from other data sources for example, the NHS Central Register (NHSCR) for mortality tracking. Examine socio-economic issues such as inequalities in access to services and outcomes, by using postcode information. In combination with other medical information, date of birth and postcode-derived deprivation information is used to provide risk adjustment for realistic statistical comparisons. These adjustments are essential to ensure that comparisons are meaningful when providing the public with information about the safety of their local services. In addition sensitive data are held on ethnicity. This is essential as the likelihood of some conditions, and outcomes, varies between different ethnic groupings.

5.6.3 It is important to stress that the reason why the audits collect identifiable information is so that the outcome of different treatments and care providers can be assessed. To do so the audits need to calculate how long a patient survives after treatment. A unique patient identifier must be retained so that records of treatment can be linked to subsequent date of death, even though this will often be years in the future. This allows lessons to be learnt and patient care to improve over time the procedures that give the best survival can be promoted, and care providers which have significantly poorer outcomes can be identified. 5.6.4 NICORs ECC application provides details on how confidentiality is protected while achieving linkage to calculate survival, the pseudonymisation processes in place for storage of data, and the anonymisation processes for reporting. It also describes the arrangements for informing patients about the use of their information and the facility to opt out, and the circumstances in which informed consent is sought and the process for obtaining it.

ECC/NIGB ref: ECC 1-06 (d)/2011 - Application for transfer of responsibility for national cardiac audits to the National Institute for Cardiovascular Outcomes Research (NICOR) at University College London.

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5.7

Involving patients in our work

5.7.1 The individual audits involve patients and their representatives in several ways: Involvement in the governance arrangements (audit boards/steering groups, clinical reference groups, etc). Commenting on draft reports. Consulted via focus groups, questionnaires, etc. Commenting on plans and the proposed design of new audits.

5.7.2 Examples include: The heart attack audit (MINAP) has a multidisciplinary steering group that includes a range of clinical professionals, NHS management and patient organisations. Patients input has proved particularly valuable when selecting the data that should be released to the public from the audit both in terms of content and its presentation. MINAP has been highlighted as a good-practice case study (Healthcare Quality Improvement Partnership 2009). Comments by patient representatives in the 2010 report include: o I emphasise the projects success by saying: if MINAP were a new drug it would be hailed as a life-saver. That is exactly what it is doing, helping to save the lives of heart patients by encouraging hospitals and ambulance services to improve performances. o To all those people who have shared in responding to the urgent needs of all these 85,000 cases over the last twelve months, in call centres, ambulances, hospitals, clinics, surgeries and community situations, and not forgetting the MINAP team, there are more of us surviving to tell the tale, walk the walk, and put our lives together again than ever before. What you have given us is the life we now lead.3 Patients and their representative groups were closely involved in the development of the website public portals that provide information on the safety of adult and paediatric heart surgeons. For example, the paediatric portal was modified to make navigation easier at the request of the Childrens Heart Federation. To date the Heart Failure Audit has undertaken two patient focus groups and consulted with patients with heart failure to identify the key issues they would want addressed in an audit and audit report. Reponses coincide with those of clinicians with regard to placing importance on accurate diagnosis and access to evidence based treatments. However patients also emphasised the importance of
How the NHS Manages Patients with Heart Attack, MINAP, 2010.

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transition, onward referral and post discharge care. Some patients report feeling lost after discharge, with a delay in being picked up by their GP or other community-based services. This has now been added to the dataset. 5.7.3 There will be a need to involve patients and their representatives in NICORs governance above the level of the individual audits. 7. Agree how patients and their representatives should be involved in NICOR governance arrangements. Lead responsible: COO. Due: October 2011. 5.8 The quality of our work

5.8.1 The national audits are without doubt valued by their participating clinicians and by the national partners who use the outputs. However, the speed of audit development and thus the quality, range and timeliness of outputs has been variable. This is partly due to funding history, resulting in unequal access to project managers and coordinators, software developers and analysts. Another factor has been the different pressures and priorities on each audit that has required some to focus more on local feedback and others on disseminating public results. NICORs establishment is an opportunity to provide a better match of resources to needs, and to promote more equal types and quality of outputs such as plain-language reports, public portals, greater involvement of patients in audit governance, etc. 5.8.2 We will set out the methodological quality standards that we aspire to. We strongly believe that clinical audit needs to be led by clinicians, because they know what the most important measures are in their specialty; they collect the data during the clinical encounter; and they are the ones who will need to change practice if necessary. However, this means that clinical audit is essentially self-regulation, and promoting it as a quality improvement tool is to grant clinicians a privilege. It follows that NICOR, when promoting clinically-led audit, has a responsibility to help protect patients by ensuring that each of our audits is conducted rigorously, accurately and fairly. The provision of public money obligates NICOR to provide good value for money. Quality assurance arrangements will be needed. The kind of methodological standards against which we should assess ourselves include: Project governance: Steering group or board established including multidisciplinary and patient representation; agreed project aims, accountability and decision-making arrangements; patient involvement during design and implementation; Prince 2 or similar project management; risk register maintained; support for participants; sound information governance; delivery of contracted requirements to time, quality and cost. Methods: The evidence base and criteria/standards against which care is measured is clearly identified; data items clearly defined, appropriate sampling (where applicable); data quality; IT; input from the multidisciplinary team and not just one professions view of what it is important to audit.
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Data management: Including standardised consistency checks on import, data cleaning mechanisms, identification of and removal of duplicate records, accuracy of mortality tracking, and reliability of export functions. Feedback and reporting: the quality and timeliness of the local feedback mechanisms; annual professional and plain language reports; data made available to SHAs, commissioners, regulators; public portals and data for NHS Choices. Improvements for patients: High participation rates (checking that all eligible hospitals take part in the audit and submit data for the required number of cases accurately and completely); communications; support for action planning; and a development plan aiming towards open publication of key findings by named local hospitals once data quality is mature.

8. Agree a set of quality standards for each NCOR audit; establish a system for assessing the audits against the standards and a development plan for each to work to. Lead responsible: COO with audit leads and Senior Programmes Manager. Due: December 2011 5.9 Principles

5.9.1 NICOR intends to behave in a manner appropriate to a public sector body. We will endeavour to: Always act in ways that will benefit patients and the public. Involve patients and representative organisations in our future planning and in the governance arrangements of our audits. Be open, transparent and honest in our behaviour.4 Involve in discussions, and keep informed, our principal departmental sponsors and funding bodies. Fully involve the clinical leads of each audit, and their specialist societies, in discussions over the deliverables that we agree with funding bodies and our IT operating partners. Ensure audits involve the full multidisciplinary team. Encourage appropriate external use of our data for research.

We intend to precede in the spirit of the Governments transparency commitments, as set out by the Prime Minister in May 2010, and confirmed in guidance published by the Office of Government Commerce (OGC) and the Public Sector Transparency Board (which has been established in the Cabinet Office). The Governments stated aims are to achieve greater transparency across its operations to enable the public to hold public bodies to account, and to help achieve better value for money.

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Promote the active participation of all clinicians in our audits, based on the principle that the most important and long-lasting improvements come when those providing care recognise the need to change and take the efforts to do so. Seek to provide value for the public money invested in our activities.

9. NICOR will conduct its business guided by an agreed set of principles, as set out in this plan. Lead responsible: all. Due: continuous.

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6 THE WORK NICOR PLANS TO DO


6.1 The scope of NICORs work

6.1.1 Our immediate priority is to deliver the seven national cardiac audits to budget, time and quality. But NICOR is poised to achieve more for the specialist societies that lead the current audits, and to expand its work to the benefit of patients (Table 6). Table 6: The possible scope of NICORs work Existing work Core audit delivery The six national cardiac audits Opportunities Other cardiovascular audits as tendering opportunities arise. Develop public portal or NHS Choices partnership for other audits.

Wider Public portals: dissemination Heart surgery in the UK of audit data (hosted by CQC) Congenital heart disease portal (hosted by CCAD) Analyses provided to CQC. Analyses for NHS choices. Analyses to inform NICE guidelines Promoting research by providing audit data Other Partnerships MINAP: c.30 research projects since 2006. Fewer, but significant projects associated with other audits. Opportunities provided by the CCPO environment and UCL Partners. International comparisons

Major opportunities exist with each of the existing audits.

Stroke audit and research work with the Royal College of Physicians. Many other opportunities. Registers for new devices /technologies

6.1.2 NICOR could: Expand the range of audit work. There may be opportunities to take on more audits covering other forms of cardiovascular disease, as the contracts to provide other existing heart disease and stroke audits come up for competitive tender. NICOR could recommend, and seek funding for, new audit topics as

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clinical practice develops (for example, mitral valve interventions, left atrial appendage occlusion, and renal artery denervation). Build on the core audit delivery work, as covered by the main HQIP contract, by contracting with UK countries other than England and forging international collaborations. Promote more research use of the data (see further below). Make findings more widely accessible to the public.

6.1.3 The NICOR Executive, together with the CCPO Board, will need to decide what opportunities it wishes to pursue and how quickly. 10. Review the initial forward plan for new work. Due: September 2011. Lead responsible: NICOR Executive. 11. Review the benefits of further public portal websites, and identify funding sources. Lead responsible: COO. Due: December 2011. 6.1.4 The HQIP contract for each audit contains a list of deliverables and due dates. While initially working to deliverables largely inherited from the previous audit suppliers, we have also been asked by HQIP to review the future direction and priorities of each audit and produce a management plan for each within the first quarter. 12. Draw up a development plan for each audit, as required by the HQIP contract. Lead responsible: Senior Programmes Manager with each audit lead. Due: July 2011. 6.2 Quality improvement

6.2.1 NICOR provides information that allows our partners to compare best standards and optimal outcomes with what happens to patients. If there is a quality gap, NICORs analyses help identify how to bridge it. It is not possible to prove that the national cardiac audits have caused improvements for patients - there are too many other factors at work. Nevertheless, there is strong anecdotal evidence that clinician involvement in them has been one of the fundamental factors where change for the better is found. For example: The Adult Cardiac Surgery Audit epitomises the value and approach of defining, collecting, analysing and publishing data led by the clinicians themselves. Better quality of care and outcomes are more likely to be real and sustainable when those most closely involved in providing the care assume leadership and responsibility for measuring and analysing it. The Society for Cardiothoracic Surgery (SCTS) has sought to develop a new approach to medical
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professionalism that includes developing a culture whereby public openness about our work and our outcomes is part of our daily lives (Bridgewater, Cooper et al. 2011) and the existence of the national audit is an integral part of this approach. This professional desire for transparency has led to casemix-adjusted information being built into a website (a public portal, http://heartsurgery.cqc.org.uk) that allows patients, their GPs and the public to look up adult cardiac surgical outcomes for their local hospital - the culmination of a main recommendation in the Bristol Inquiry Report. The SCTS believe that open publication has played its part in the reductions in mortality seen over the years, with no evidence that fewer high risk patients are undergoing surgery because mortality rates are published (Bridgewater, Grayson et al. 2007). In addition to allowing patients, GPs and the public to look up adult cardiac surgical outcomes for their local hospital, the website also provides general information about different operations, the benefits of having heart surgery, what to expect after having an operation, and details about each hospital and the heart team. Not only is the audit stimulating improvements in the quality of care by providing feedback to clinicians, it is also helping patients to ask questions about their care, providing public reassurance where results are good, and allowing challenge where they are not. This focus on transparent publication of outcomes, linked to the recommendations from the Bristol Inquiry, is of course also central to the approach of the Congenital Heart Disease Audit. Patients, parents and the public can find information about and see the results for the different congenital heart disease centres (http://www.ccad.org.uk/congenital). This audit holds the only complete and validated database for congenital heart disease in the world. Congenital heart disease takes many different forms and there are numerous different treatment procedures, making interpretation of outcome data far more complex than for other forms of surgery. Casemix varies considerably between different centres and between individual operators and as research continues to try to define a means of risk stratifying these treatments, survival data is currently presented for the mainstream specific procedures for each centre and for the national aggregate of these specific procedures. The Cardiac Rhythm Management CRM) audit has highlighted major underprovision generally UK implantation rates are amongst the lowest in Western Europe despite evidence refuting any difference in the prevalence of conditions for which implantation is indicated or the over-prescription of devices in other countries and, benchmarked within England, After correction of device implant rates for the age and sex distribution of populations there is evidence of major variability or inequity of provision between PCTs which could not be explained on clinical grounds (Pacemakers and Implantable Defibrillators: A Two Year National Survey for 2003 and 2004, Network Devices Survey Group, 2006). PCTS and cardiac networks are given detailed information about local under provision, including maps. The report found that NICE guidance and other published evidence was not always being followed, and recommended changes

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to clinical practice and a review of PCT commissioning and investment strategies. Of the many improvements in care highlighted by the different cardiac projects, the improvements in hospital door to needle and patients call to needle times demonstrated by MINAP re-audits have achieved classic status as amongst the most high profile of all improvements demonstrated by closing the audit loop. Surviving a heart attack depends critically on how quickly treatment is given following onset of symptoms after the attack. The improvements seen each year since the inception of MINAP in the time taken to give thrombolytic treatment (clot dissolving drugs) to suitable patients and the use of drugs to reduce the risk of another heart attack (secondary prevention) are the result of actions taken by the ambulance services, A&E departments and cardiac care units. Many extra lives have undoubtedly been saved. Of course it cannot be proved that the audit was the sole or even main reason for the trends, given that other initiatives to promote the achievement of the NSF target were happening at the same time such as its inclusion as a performance-managed national target in the Priorities and Planning Framework (PPF) 2003-2006. But most would agree that publicising the comparative data on performance was a fundamental spur to improvement. In fact there are case studies in the 2007 MINAP public report that identify the specific role of the audit in spurring improvements. For example, one NHS trust described how Monthly meetings were arranged between the Trust & Ambulance personnel where problems were shared... Every patient was investigated if the target was missed and action plans were formed to reduce the risks of the same reasons reoccurring... The number of patients having prehospital thrombolytic treatment has increased by 233% in the last year (source: MINAP public report 2007). The Adult Interventions Audit provides an excellent example of how a close focus on data completeness and quality can help individual hospitals understand their place and performance - in rapidly-changing treatment settings. Fast, reliable feedback is essential as more heart attack patients are treated via intervention rather than with thrombolysis, with constantly changing reconfiguration as some hospitals are designated as heart attack centres. Primary angioplasty is now the preferred reperfusion therapy for patients with ST elevation myocardial infarction (STEMI). At first many hospitals had no idea how they were performing as they did not take part in the audit. But a focus on detailed, publicly available feedback and the efforts of local clinicians to ensure their hospitals take part has led to nearly 100% participation and a high level of data completeness. Currently there is considerable variation in both door-to-balloon and call-to-balloon times, both measures of process that affect outcomes. Clear reports on where data errors remain for each hospital prompts change. The audit provides the fast feedback essential for those centres with poor times to identify how much better they could be doing they need to learn from centres that are performing well and hopefully this variance will reduce over the next few years. (National Audit of Angioplasty Procedures 2010).

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Heart failure is one of the commonest reasons for emergency medical admissions (about 5%), readmissions and hospital bed-days occupancy. Yet until the Heart Failure Audit began little was known about the quality of care and outcomes for each hospital. Annual mortality analyses from the audit confirm that the prognosis is poor (30% at one year). Surviving patients with heart failure have a poor quality of life, with over a third experiencing severe and prolonged depressive illness. Yet there is good evidence that appropriate diagnosis, treatment and ongoing support can improve quality of life, help reduce morbidity and mortality and reduce hospital admission. But the audit shows that this care is often absent and feedback to individual hospitals is opening eyes to the need to improve (for example, NICE-recommended Beta-blockers are often underused; and mortality is significantly better for those who have access to specialist care (ie, those seen by cardiologists) or specialist heart failure services. This feedback should now prompt poorly-performing hospitals to streamline the heart failure care pathway to ensure all patients, regardless of admission ward, have access to recommended medication in line with NICE guidelines and that treatment is managed by specialist staff.

6.2.2 The NICOR audits will continue to place an important focus on the action and improvement that follows analysis of audit findings. Other sections have set out the different audiences for which the audits produce analyses and reports, including the use of searchable websites. We will further review the need to provide local hospitals with template action plans and other ways to share good practice in how to improve the quality of care and outcomes. 13. Review the scope for each audit to further promote quality improvement beyond the provision of feedback audit information (for example, template action plans, sharing workshops). Lead responsible: clinical leads and NICOR staff. Due: December 2011. 6.3 Research use of national audit data

6.3.1 Clinical guidelines are usually derived from research evidence produced using randomised control trial (RCT) methodology. However, even the largest trials are limited in the number of patients involved, exclusion criteria and the length of time over which they are conducted. By contrast, the national cardiac audit databases contain very large numbers of patients from most or all UK hospitals going back some years and are much more representative of real populations: The MINAP database contains over 840,000 patient records dating back about 10 years, with 90,000 uploaded last year. The Adult Interventions database contains details of over 460,000 PCI procedures, with over 80,000 added last year. The Adult Cardiac Surgery database contains over 400,000 operation records.
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CRM has records for about 750,000 implanted devices, with over 50,000 implanted last year. The Congenital Heart Disease database has over 70,000 records following surgery or therapeutic catheterisation. The Heart Failure database (a comparatively new audit) has about 30,000 records.

6.3.2 While other large databases exist, such as Hospital Episode Statistics (HES), the audit datasets contain much more clinical detail than such standard information sources. For example: HES cannot distinguish between ST elevation myocardial infarction (STEMI) and non-STEMI patients, a distinction of fundamental importance to interpreting heart attack data in ways that can influence and improve clinical practice. MINAP allows this distinction to be made. HES often has secondary diagnoses (comorbidities) missing. This reduces the ability to casemix adjust survival rates and provide meaningful comparisons (Black 2010). The national audits collect the necessary information.

6.3.3 The research use of these large, long-running and clinically detailed audit databases can complement, test and expand the lessons derived from RCTs: The databases can be used to investigate whether guidelines based on the evidence from RCTs are being applied by clinicians in real life clinical situations and, if not, help identify strategies to improve their use. They can evaluate whether the guidelines are relevant to populations not covered by the original RCTs, and assess longer-term risks (McNamara 2010). The databases allow real life measurement of accepted clinical practice and guidelines, including analysing whether the guidelines derived from RCTs apply in the real world, or need adaptation.

6.3.4 For example, in the last five years a broad range of projects (with funding exceeding 10 million) have been undertaken using extracts of MINAP data following approval by the MINAP Academic Group (MAG). This research has already helped to build on RCT evidence, for example:5 In the period from 2004 to 2007 hospitals specialising in treating heart attacks using primary PCI (ie, treating a high proportion with primary PCI rather than with thrombolytic drugs) had less delays to treatment and lower death rates

These interpretations reflect those of the author of this strategy document, and not necessarily those of the authors of the academic publications cited.

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This kind of real-life information - not available via RCTs - is of crucial importance to those considering the reconfiguration of services, in particular the value of establishing heart attack centres (West, Cattle et al. 2011). RCT evidence suggests there will be fewer deaths if patients with NSTEMI are treated via an early invasive approach. However, in some aspects the RCT evidence is uncertain for example, as to whether women derive a similar benefit as men. Analysis of real life MINAP data showed that women were less likely to receive angiography, perhaps reflecting this uncertainty amongst clinicians. MINAP data showed that performance of angiography and coronary intervention after NSTEMI was indeed associated with reduced mortality (thus confirming the overall RCT evidence) but, importantly, also found that the benefit was similar for both sexes. This finding should thus be able to reduce uncertainty and influence clinical practice for the better (Birkhead, Weston et al. 2009). The MINAP database was used to investigate the impact of pre-hospital thrombolytic treatment on re-infarction rates. The influence and interaction of many different variables would make such investigation hard to achieve via RCTs. One type of drug was found to be associated with higher re-infarction rates when used pre-hospital, although there was no difference withinhospital. The analysis also found that real-life re-infarction rates are higher than those reported in many RCTs. The findings have implications for changes to clinical practice that add to the lessons available from the RCTs (Horne, Weston et al. 2009). The database was used to investigate whether South Asian patients might experience inequitable access to cardiac services. The data revealed that such patients were less likely to arrive by ambulance, but were not disadvantaged in terms of treatment offered or its timings once within hospital (Ben-Shlomo, Naqvi et al. 2008) Risk adjustment is important to ensure comparing like with like when using audit findings to compare hospital performance as discussed elsewhere in this document. But risk stratification is also, of course, important in the clinical situation to help guide appropriate decisions. For example, Patients at highest risk for adverse outcomes may derive greater benefit from the use of effective treatments, and this benefit may be more likely to outweigh risk inherent to certain treatments. The MINAP database has been used to test and validate five acute coronary syndrome risk scores, demonstrating that a simple model can predict 30-day mortality as well as more complex models. Such analyses can thus lead to developments of practical use to clinicians (Gale, Manda et al. 2009).

6.3.5 This kind of research demonstrates that the national cardiac audits can offer a double benefit Firstly, the local use of feedback data can improve call and door-totreatment times, which leads to fewer deaths. But the findings can also build on and
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refine RCT evidence to alter guidelines and clinical practice, which in turn will further reduce deaths. MINAP has provided analyses to inform the recent NICE guideline (CG94) on the management of nSTEMI. NICORs position within UCL (ranked in the worlds top 10 universities) and UCL Partners (probably bringing together the largest number of academic and service delivery cardiovascular clinicians and scientists in the UK), offers significant opportunities to further exploit this research capability. 14. Develop data sharing criteria and agreements for the use of each audits data. Lead responsible: audit clinical leads. Due: October 2011. 6.4 Revalidation

6.4.1 Revalidation is the process through which doctors are expected to demonstrate regularly that they are up to date and fit to practise in their chosen field (Bridgewater, Cooper et al. 2011). 6.4.2 Clinicians involved with the audits are in discussion with royal colleges about whether information in support of revalidation might be made available. Outputs might promote reflection on individual and team performance. Outcomes information is likely to be used increasingly during revalidation as systems develop. 15. Discuss with those responsible for revalidation how the audits can contribute. Lead responsible: audit clinical leads. Due: continuing.

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7 INFRASTRUCTURE
7.1 Human resources

7.1.1.1 Organisational structure 7.1.2 The initial posts and line management arrangements proposed to deliver NICORs work are set out in Figure 5. IT services will be delivered by a team line managed within AISC. However, the posts are funded via ring-fenced funding from the NICOR budget and their job descriptions restrict the posts to national audit work. The IT delivery will be managed by an SLA that will incorporate expected turn-round times for development work, error-fixing, enquiries, data extracts, etc (a service specification with the NHS IC in turn sets out helpdesk and system maintenance times). Despite these formal governance arrangements, we envisage that the individual staff will work closely together in a cooperative matrix-working manner. Figure 5: Proposed NICOR organisational structure
NICOR
NATIONAL INSTITUTE FOR CARDIOVASCULAR OUTCOMES RESEARCH

UCL.
IT
AISC Group Manager National Clinical Audit Service Manager

CLINICAL
Medical Lead Academic Lead Audit Leads: 1. Adult cardiac interventions 2. Adult cardiac surgery 3. CRM (Cardiac rhythm management) 4. Congenital heart disease 5. Heart failure 6. MINAP (Myocardial infarction, heart attack) 7. TAVI (Transcatheter Aortic Valve Implantation)

SUPPORT
COO Senior CCAD Strategist

Office & Business Manager

Programme Manager
Project Managers

Senior Analyst

Senior Clinical Audit Developers Clinical Data Auditor/ Coordinator


Developer contracts

Analysts

Business Support Officers

Coordinators

Analyst contracts

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16. Proposals for the organisational structure and priorities for recruitment to NICOR to be put to the Board and Executive. Lead responsible: COO. Due: August 2011. 7.2 Accommodation

7.2.1 Initially NICOR will be located at 175 Tottenham Court Road. The offices can accommodate about 17 people. It is not big enough to allow either co-location with other CCPO colleagues nor expansion as NICOR seeks to recruit staff and extend the range of its work. We are actively exploring other options. Larger space will be required within a year. 17. Identify alternative accommodation to be available from 1 April 2012. Lead responsible: ICS manager, NICOR co-chairs. Due: Oct 2011. 7.3 IT

7.3.1 The national audits will continue to be supported by the same staff that managed the IT environment when with the NHS Information Centre. 7.3.2 The Central Cardiac Audit Database (CCAD) has grown from a small-scale, stand-alone pacemaker database taking in small batches of records entered centrally, through 30 years of evolution, to todays sophisticated system based on Lotus Notes. CCAD now covers many different aspects of cardiac care, offering a data entry system for hundreds of hospitals, with online reporting. 7.3.3 For the first year the data will continue to be hosted on secure servers maintained by the NHS IC. In addition the IC will provide first-line helpdesk functions. The service is managed via a subcontract. 7.3.4 Looking forward, to ensure the system is future proofed, NICOR will: Move the data hosting and helpdesk functions into UCL, to provide better value for money and greater flexibility and control. Ensure the system is capable of dealing with increasing input both in terms of the number of audits and patient records, and the types and speed of output required. 7.3.5 Initially carrying on an uninterrupted service, we will conduct an options appraisal that will consider how best to proceed, including whether re-developing via a new application might bring benefits and make business sense.

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18. Conduct an options appraisal in relation to the IT system, considering (a) moving the data hosting and helpline functions into UCL and (b) the costs and benefits of maintaining the current platform compared with developing a new application. Lead responsible: Director AISC and Senior CCAD Strategist. Due: March 2012. 7.4 Finance

7.4.1 NICOR starts with funding from the Department of Health (provided via a contract with HQIP) intended to cover the core costs of six national cardiac audits. In addition we have received grants from the British Heart Foundation, the National Specialist Commissioners, the GA Moore Foundation and the Association of British Healthcare Industries (ABHI). In 2011/12 this totals 1.84m (Table 7). Table 7 NICORs grant income (at June 2011)
2011/12 2012/13 2013/14 Income Total 1,839,777 1,809,103 1,747,121 5,396,000

7.4.2 As NICOR develops our financial strategy could change significantly. However, our immediate plan is to grow our effectiveness: We must identify funding to continue and develop the CRM audit beyond March 2012. Estimate: 250,000 per year. NICOR will bid for other audits that fit our purpose as tendering opportunities arise. Economies of scale will allow us to deliver each individual audit more efficiently and develop our joint working with CCPO. Estimate: 500,000 in year two. We will develop a cost-recovery system for extra, complex analyses carried out for external partners. Such work would be agreed via a NICOR committee and each bid would be evaluated against an agreed set of criteria. The over-arching criterion would be that it must demonstrably add to the patient benefits already derived from the core audit work, and the second most important criterion is that it must enhance and not in any way jeopardise delivery of the core audit work. The policy and processes involved in this will be agreed with HQIP it is not intended to generate extra income, simply to cover the costs of meeting external data requests that are not covered by the core HQIP funding. We are working to estimate the likely value of this work. Research based on use of the audit data is usually conducted by external organisations, and any large costs to NICOR will be met via the cost-recovery
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system just described. However, NICOR could also support the specialist societies if they wished to apply for research grants to be based within NICOR. Estimate: 250,000 per year. NICOR will seek sponsorship for specific developments for example, sponsorship of the capital costs of developing IT applications, or to support a new devices and technologies (following the example of TAVI). Estimate: 200,000 per year. As our relationships within CCPO develop, we expect to become further integrated (while preserving the ring-fenced funding and delivery of the core audit work as defined by the HQIP contract and its deliverables). 2011/12

7.5

7.5.1 The HQIP contract requires NICOR to review the deliverables that have largely been inherited from the previous audit suppliers, and produce a management plan for each audit. Following this work we will review with HQIP the core budgets allocated initially to each audit. 7.5.2 In addition to providing the core audit service to local trusts, we are required by the HQIP contract to deliver what might be termed a normal amount of development work for each audit (eg, minor annual dataset revisions). But there may appear over the three year period a need for more major developments. To manage this: We will set aside an amount (either in terms of existing staff time or money that can be spent on contract staff) that individual audits can bid to use. We will establish criteria to identify which internal bids should take priority. The Executive will make the decisions. If demand for developments by the individual audits exceeds the available resources, we will seek external funding. We also intend to seek sponsorship for the once-off costs associated with developing a new IT application that will be required after the NHS IC data hosting and helpdesk subcontract ends. 7.6 Communications

7.6.1 We will use the NICOR pages within the Institute of Cardiovascular Sciences/UCL website to ensure that each audit is described and the necessary user documentation, plus public and professional reports, are accessible (http://www.ucl.ac.uk/nicor/).

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19. Ensure NICOR web pages contain the necessary information, documentation and reports for each audit. Lead responsible: NICOR webmaster. Due: July 2011. 7.6.2 The communications plan will set out the range of documents that NICOR should have. The intention is that this strategy and business plan, plus an annual report, should be publicly available documents. Each individual audit will have its own communications plan. 20. Develop NICORs communications plan. Lead responsible: COO. Due: November 2011. 21. Develop a communications plan for each audit. Lead responsible: audit project support and audit leads. Due: November 2011 or as already specified in contract deliverables. 7.7 Risk management

7.7.1 Each audit will maintain a risk register, and NICOR will maintain a corporate risk register. We will develop the registers in due course but examples of risks identified during the transition phase are given in Table 8.

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Table 8: Initial top level risks for NICOR


A risk register setting out the mitigating actions, risk ownership and monitoring arrangements will be prepared. Likelihood Overall Risk 6 6 6 8 4 6 5 6 4 6 5 4 5 4 4 Impact ID Issue

A 1 2 B 3 C 4 5 D 6 7 E 8 9 F 10 11 G 12 13 14 H 15

Governance Role of specialist societies and relationship to NICOR/UCL not agreed Fail to meet data protection/information governance legal requirements Finance and contracts Failure to deliver key HQIP contract deliverables IT Data hosting or helpdesk arrangements, secured via sub-contract, fail in ways that we cannot manage Fail to carry out, or act on, options appraisal about future IT platform Staffing Loss of experienced staff in key positions Failure to recruit to key posts (eg, Snr Analyst) Communications FOI requests before data are sufficiently complete, accurate and casemix-adjusted Insufficient patient involvement The Audits Unable to secure income for CRM for 2012/13 and beyond Participation rates are not high enough, or data completeness or quality not good enough Stakeholders Fail to meet CQC, MHRA, NHS Choices data requests Fail to promote NICOR effectively Fail to agree data sharing protocol, fail to release data appropriately Estates NICOR outgrows 175 TCR before larger accommodation can be secured

3 3 2 3 2 2 2

1 2 2 2 1 2 2

2 2 3 2 2 2 1 2

2 1 2 2 1 2 2 1

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When 2 1 2 3 1 2 1 2 1 1 1 1 1 1 1

8 SUMMARY ACTION PLAN

Action

Page

1.

Board and Executive to discuss and agree wording of NICORs purpose, aim and objectives. Lead responsible: Board and Executive. Due: September 2011. ......................................................................................................................... 16 Agree details of what is core audit work and what is extra work for which NICOR should pursue funding. Lead responsible: Executive. Due: August 2011. ......................................................................................................................... 18 Review Board and Executive membership and meeting frequency. Lead responsible: Board and Executive. Due: October 2011. ................................... 20 Proposals for the longer-term governance structure of NICOR to be put to the Board and Executive. Lead responsible: COO. Due: September 2011............. 20 Terms of reference (TOR) are required for the Board, Executive and each committee, once the NICOR structure is finalised. TORs must specify decisionmaking arrangements and lines of accountability. Lead responsible: committee chair. Due: within 4 weeks of committee being established. ............................. 22 A full set of necessary policies is required. Lead responsible: COO. Due: draft within 4 weeks of a necessary issue being identified. ....................................... 22 Agree how patients and their representatives should be involved in NICOR governance arrangements. Lead responsible: COO. Due: October 2011. ........ 26 Agree a set of quality standards for each NCOR audit; establish a system for assessing the audits against the standards and a development plan for each to work to. Lead responsible: COO with audit leads and Senior Programmes Manager. Due: December 2011 ........................................................................ 27 NICOR will conduct its business guided by an agreed set of principles, as set out in this plan. Lead responsible: all. Due: continuous. ................................... 28

2.

3. 4. 5.

6. 7. 8.

9.

10. Review the initial forward plan for new work. Due: September 2011. Lead responsible: NICOR Executive. ........................................................................ 30 11. Review the benefits of further public portal websites, and identify funding sources. Lead responsible: COO. Due: December 2011. ................................. 30 12. Draw up a development plan for each audit, as required by the HQIP contract. Lead responsible: Senior Programmes Manager with each audit lead. Due: July 2011. ................................................................................................................. 30 13. Review the scope for each audit to further promote quality improvement beyond the provision of feedback audit information (for example, template action plans, sharing workshops). Lead responsible: clinical leads and NICOR staff. Due: December 2011. ............................................................................................... 33
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14. Develop data sharing criteria and agreements for the use of each audits data. Lead responsible: audit clinical leads. Due: October 2011. .............................. 36 15. Discuss with those responsible for revalidation how the audits can contribute. Lead responsible: audit clinical leads. Due: continuing..................................... 36 16. Proposals for the organisational structure and priorities for recruitment to NICOR to be put to the Board and Executive. Lead responsible: COO. Due: August 2011. ................................................................................................................. 38 17. Identify alternative accommodation to be available from 1 April 2012. Lead responsible: ICS manager, NICOR co-chairs. Due: Oct 2011. .......................... 38 18. Conduct an options appraisal in relation to the IT system, considering (a) moving the data hosting and helpline functions into UCL and (b) the costs and benefits of maintaining the current platform compared with developing a new application. Lead responsible: Director AISC and Senior CCAD Strategist. Due: March 2012....................................................................................................... 39 19. Ensure NICOR web pages contain the necessary information, documentation and reports for each audit. Lead responsible: NICOR webmaster. Due: July 2011. ................................................................................................................. 41 20. Develop NICORs communications plan. Lead responsible: COO. Due: November 2011. ............................................................................................... 41 21. Develop a communications plan for each audit. Lead responsible: audit project support and audit leads. Due: November 2011 or as already specified in contract deliverables. ........................................................................................ 41

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By 31 Mar 2011

2011/12 2012/13 2013/14


FUNDING Sign HQIP contract (core funding for six audits). Agree development plans with HQIP. CRM: identify interim funding. CRM: secure longer-term funding (eg, levy model). Agree and deliver core staffing resources for each audit. Identify funding to achieve each audit's priority developments. Bid for other existing cardiovascular audits as opportunity arises. Bid for renewal of HQIP core contract. DELIVERY IT options appraisal (data hosting, main application). Pilot and implement any agreed new IT arragements. Foster further research use of audit data. Agree QA standards that all audits should meet. Annual professional and public reports issued by each audit. Portal developed or NHS Choices contribution implemented for each audit. NICOR recognised as centre of national audit and research excellence. GOVERNANCE Complete TUPE transfer of CCAD staff. Agree NICOR organisational structure. Agree strategic and business plans. Recruit staff. Agree work allocation and cost-recovery arangements for extra work. Agree how NICOR works with the Cardiovascular Prevention & Outcomes Centre (CPOC).

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9 ANNEXES
9.1 BHF CCPO DH Abbreviations British Heart Foundation. Funds some of NICORs work. Centre for Cardiovascular Prevention and Outcomes. Close partner of NICOR within UCL. Department of Health. Commissions and funds the national cardiovascular clinical audits, via NCAAG and HQIP. East Midlands Specialised Commissioning Group. Funds some of NICORs work. Healthcare Quality Improvement Partnership. Identifies audit providers, manages funding and monitors contract performance on behalf of DH and NCAAG. National Clinical Audit Advisory Group. Advises the DH. National Institute of Cardiovascular Research. Provides national clinical audits. Non ST-elevation myocardial infarction ST-elevation myocardial infarction

EMSCG HQIP

NCAAG NICOR NSTEMI STEMI

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REFERENCES

Ben-Shlomo, Y., H. Naqvi, et al. (2008). "Ethnic differences in healthcare-seeking behaviour and management for acute chest pain: secondary analysis of the MINAP dataset 2002-2003." Heart 94(3): 354-359. Birkhead, J. S., C. F. Weston, et al. (2009). "Determinants and outcomes of coronary angiography after non-ST-segment elevation myocardial infarction. A cohort study of the Myocardial Ischaemia National Audit Project (MINAP)." Heart 95(19): 1593-1599. Black, N. (2010). "Assessing the quality of hospitals." BMJ 340: c2066. Bridgewater, B., G. Cooper, et al., Eds. (2011). Maintaining Patients Trust: Modern Medical Professionalism, Dendrite Clinical Systems on behalf of the Society for Cardiothoracic Surgery in Great Britain & Ireland. Bridgewater, B., A. D. Grayson, et al., Eds. (2007). Has the publication of cardiac surgery outcome data been associated with changes in practice in northwest England: an analysis of 25,730 patients undergoing CABG surgery under 30 surgeons over eight years. Heart. Gale, C. P., S. O. Manda, et al. (2009). "Evaluation of risk scores for risk stratification of acute coronary syndromes in the Myocardial Infarction National Audit Project (MINAP) database." Heart 95(3): 221-227. Healthcare Quality Improvement Partnership (2009). National Voices report: Patient and Public Involvement in Clinical Audit, HQIP. Horne, S., C. Weston, et al. (2009). "The impact of pre-hospital thrombolytic treatment on re-infarction rates: analysis of the Myocardial Infarction National Audit Project (MINAP)." Heart 95(7): 559-563. McNamara, R. L. (2010). "Cardiovascular registry research comes of age." Heart 96(12): 908-910. National Clinical Audit Advisory Group (2009). What is clinical audit?, NCAAG, DH. West, R. M., B. A. Cattle, et al. (2011). "Impact of hospital proportion and volume on primary percutaneous coronary intervention performance in England and Wales." Eur Heart J 32(6): 706-711. Weston, C. F. (2008). "Performance indicators in acute myocardial infarction: a proposal for the future assessment of good quality care." Heart 94(11): 13971401.

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