nicorstrategy.pdf

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NICOR:The National Institute for

Cardiovascular OutcomesResearch

STRATEGY and

BUSINESS PLAN

Au ust 2011

NICOR at the Institute of Cardiovascular Science,

University College London.


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dw: \NICOR strategy-BP 100811.doc last saved: 10/08/11 page 2 of 47

Contents

1 Summary ............................................................................................................. 32 Mission statement ............................................................................................... 53 Context ................................................................................................................ 6

3.1 What is NICOR? ............................................................................................ 63.2 A national cardiac registry, clinical audit and outcomes system .................... 73.3 Remit ........................................................................................................... 103.4 Policy and legislative framework ................................................................. 123.5 Preparing for the first year ........................................................................... 14

4 Strategic direction.............................................................................................. 154.1 Purpose, aim and objectives ....................................................................... 154.2 Core activities and enabling wider benefits ................................................. 16

5 Governance ...................................................................................................... 195.2 Board and Executive ................................................................................... 195.3 Role of the specialist societies .................................................................... 205.4 Committee structure .................................................................................... 205.5 Terms of reference (TOR) and policies........................................................ 225.6 Information governance .............................................................................. 235.7 Involving patients in our work ...................................................................... 255.8 The quality of our work ................................................................................ 265.9 Principles .................................................................................................... 27

6 The work NICOR plans to do ............................................................................ 296.1 The scope of NICORs work ........................................................................ 296.2 Quality improvement ................................................................................... 306.3 Research use of national audit data ............................................................ 336.4 Revalidation ................................................................................................ 36

7 Infrastructure ..................................................................................................... 377.1 Human resources ........................................................................................ 377.2 Accommodation .......................................................................................... 387.3 IT ................................................................................................................. 387.4 Finance ....................................................................................................... 397.5 2011/12 ....................................................................................................... 407.6 Communications ......................................................................................... 407.7 Risk management ....................................................................................... 41

8 Summary action plan ........................................................................................ 439 Annexes ............................................................................................................ 46

9.1 Abbreviations .............................................................................................. 46References ............................................................................................................... 47


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1 SUMMARY

NICOR (the National Institute for Cardiovascular Outcomes Research) is part ofthe Centre for Cardiovascular Prevention and Outcomes at University CollegeLondon. We are a unique partnership of clinicians (from local hospitals, thenational specialist societies and DH), IT experts, analysts, academics andmanagers. NICOR enables clinicians to take a leading, central part in the NHSinformation revolution.

Our mission is to provide information to improve heart disease patients quality ofcare and outcomes. NICOR collects patient information from UK hospitals intosecure cardiovascular registries established by the specialist clinical societies.

We then help the NHS, the government and regulatory bodies improve quality bychecking that care meets good practice standards through clinical audit, and bycomparing outcomes such as casemix-adjusted survival rates. Our reports andonline public portals help patients make choices, and build public confidence inNHS cardiac care. NICOR encourages research using real world data tocomplement and refine the lessons learnt from randomised clinical trials.

This document sets out our longer-term strategy and details what we will doduring 2011/12. NICORs initial focus is to manage six national cardiovascularclinical audits and their associated registries:

Audit Patients Lead specialist societyAdult cardiacsurgery

All adult patients undergoing major heartsurgery.

Society for CardiothoracicSurgery (SCTS)

Cardiacinterventions

All adult patients on whom a percutaneouscardiovascular intervention procedure isperformed.

British CardiovascularIntervention Society (BCIS)

Cardiacrhythmmanagement(CRM)

All adult patients with implanted devices orreceiving interventional procedures formanagement of cardiac rhythm disorders.

Heart Rhythm UK (HRUK)

Congenitalheart disease

All cardiac or intrathoracic great vesselprocedures carried out in patients under the

age of 16 years, and all adult congenitalcardiac procedures performed for a cardiacdefect present from birth.

British Congenital CardiacAssociation (BCCA)

Heart failure All patients with an unscheduled admissionto hospital with heart failure.

British Society for HeartFailure (BSH)

MINAP All adult patients with acute coronarysyndromes.

British CardiovascularSociety (BCS)

TAVI All patients undergoing Transcatheter AorticValve Implantation

BCIS and SCTS

NICOR has particularly close relationships with the specialist cardiovascular

societies. They provide the clinical leadership for each registry and audit, andmost 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 theuse of commissioners, providers, and patients.

NICOR must handle sensitive, confidential information about individual patients inorder to fulfil its purpose. Our system security arrangements meet Ethics andConfidentiality Committee requirements, and UCL has been granted approvalunder section 251 of the NHS Act 2006 to process patient audit data.

NICOR starts with funding from the Department of Health (provided via a contractwith HQIP) intended to cover the core costs of six national cardiac audits for threeyears. In addition we have received grants from the British Heart Foundation, the

National Specialist Commissioners, the GA Moore Foundation and theAssociation 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 nationalaudits. To prepare for this we will be reviewing our methodology, including the ITsystems which underpin our activities. During 2011/12 data hosting and first-linehelpdesk facilities for local hospitals are provided under subcontract by the NHSInformation Centre. We aim to take full control of all audit functions in the nearfuture.


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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 area unique partnership of clinicians (from local hospitals, the national specialistsocieties and DH), IT experts, analysts, academics and managers. We will:

1) Collect patient information from UK hospitals into secure cardiovascular registriesestablished by specialist clinical societies.

2) Check that care meets good practice standards through clinical audit, and reporton outcomes such ascasemix-adjusted survivalrates and patientexperiences.

3) Support NHS qualityimprovement by providingfeedback to hospitals,networks, commissioners,government departments

and regulators.

4) Help patients makechoices and providepublic assurance via ourreports and online publicportals.

5) Encourage researchusing real world data tocomplement and refine

the lessons learnt fromrandomised clinical trials.

6) Enable clinicians to take aleading, central part in theNHS informationrevolution.

7) Through measurement,improve and build publicconfidence 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) existsto improve the care and outcomes of patients with cardiovascular disease byproviding high quality comparative information. Established by Sir Bruce Keogh, nowNHS Medical Director, NICOR is led by Professor Sir Roger Boyle and ProfessorJohn Deanfield, in association with the specialist clinical societies responsible foreach of the national audits.

3.1.2 Clinicians lead the audits, working together with information managementexperts. The audits have many partners (as described further below) but in particularthere is a close relationship with local hospitals which submit data to the registriesand receive in return comparative audit reports. NICOR sits within the Centre forCardiovascular Prevention and Outcomes Centre (CCPO), which is in turn part of theInstitute of Cardiovascular Science at University College London (UCL) - Figure 1.

Figure 1NICORs position within UCL, and its main partners

Audit & Outcomes

Audit/registry

committee

Management

team

PreventionPolicy &

Economics

CCPO BoardNICOR: National Institute for Cardiovascular

Outcomes Research

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

NICOR Executive

Academic

committee

UCL

School of Life & MedicalSciences

Faculty of Biomedical Sciences

Institute of

Cardiovascular Science

CCPO: Centre for Cardiovascular

Prevention & Outcomes

3.1.3 Currently most of NICORs funding comes from the Healthcare QualityImprovement 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 GAMoore Foundation and the Association of British Healthcare Industries (ABHI). Thefunding 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 forthe 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 acutehospitals; through ambulance services, cardiac networks, commissioners and SHAs;to the national level. The main partners that work with NICOR are summarised inBox 1.

3.2.2 NICOR provides its NHS partners with clinical audit and outcome feedback tohelp them monitor and plan how to improve the quality of care for patients withcardiovascular conditions. The national registries are part of a sophisticated IT-basedsystem that links data entry from every acute hospital with a secure central database(the Central Cardiac Audit Database CCAD). Online reports are provided forparticipating hospitals that compare their performance with others and against goodpractice standards. There is a strong emphasis on data checking and quality at alllevels and, where possible, on risk-adjusting analyses to ensure that we comparelike with like making the outputs more accurate and clinically relevant than thatavailable from routine systems such as the Hospital Episode System (HES). Bothprofessional and public reports are produced. Outputs are also provided forregulatory bodies (eg, the Care Quality Commission (CQC) and the Medicines and

Healthcare products Regulatory Agency (MHRA)), for patients and the public viapublic 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 clinicaltrial data.

Box 1: NICORs partners

Sponsors National Clinical Director for Heart Disease & Stroke, and theDH Vascular Programme.

Specialist clinical societies.

Governance NICOR Board and Executive (external members include theNHS 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 meetingexplicit criteria.

Funders HQIP, the British Heart Foundation National SpecialistCommissioners, GA Moore Foundation, Association of BritishHealthcare Industries (ABHI) (EMSCG).

Clinicalleadershipand support

Clinical leads from specialist professional societies lead eachaudit.

NICOR staff provide advice and support to local users andthe clinical lead, analyse the data and produce reports.

IT serviceproviders

The Advanced Information Systems Centre at UCL runs themain Central Cardiac Audit Database system (CCAD).

Commercial and local data entry systems interface with themain system.

Local users Local members of the specialist clinical societies, and othermembers of the multidisciplinary team, submit data and usethe feedback.

NHS Trusts enable clinicians to participate. The IT and staffcosts of taking part are met by local Trusts.

Cardiac networks, commissioners and SHAs use the findings.

Regulators CQC, MHRA and NPSA use the findings during theirassessment, inspection and registration activities.

Othernational-level users

DH for the NHS Operating Framework, and other users suchas NHS Choices.

Researchers seeking access to the audit data.

Patientsand thepublic

Patients can directly use information via the two publicportals that currently exist, public reports and through NHSChoices, to inform themselves and help make decisionsabout their care.

Providersofthesystem

Usersofthefindings


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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 systemprovided via the NICOR Board and Executive:

Local participants: Local clinicians input data and use the comparative feedbackto review their clinical practice. Trust boards can use the findings to review thequality of care, and report on audit participation in their Quality Accounts. Thedesign of the audits seeks to reduce the local costs of participation as far aspossible. For example, the Adult Cardiac Surgery Audit estimates that theaverage 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 setaside for supporting professional activities (SPAs) within most consultant

contracts (Bridgewater, Cooper et al. 2011). NHS Trusts meet the costs of local ITinterface and any extra staff costs involved in collecting and entering data. Thelevel of local costs will vary for each audit, but in the case of Adult CardiacSurgery have been estimated at 0.7% of the service cost (Bridgewater, Cooper etal. 2011).

Figure 3: NICORs national system and the partners involved

NICOR Board & Executive

Governance Central Cardiac Audit Database (CCAD) within the AdvancedInformation Services Centre (AISC), UCL:

System maintenance & back-upLink to other datasets

System security

Dataset changes

Error checks

Software fixes

Development

NHS IC:

Data hosting

Helpdesk

Local hospitals:Collect & input data

Check data quality (DQ)

Use reports

Data

entry

External organisations:Specialist societies

CQC, MHRA (regulation)

Cardiac Networks

Commissioners, SHAs

NHS Choices

Research groups

Views &

reports

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

Data extracts,

reports,

public portals

Secure

repository


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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 tolocal participants, helping to share good practice in data entry and in using thefeedback to improve patient care. We carry out analyses on the datasets andproduce 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) alsouse 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 programmingsupport for the individual audits. AISC provides an interface into CCAD for themany variants of local data entry systems that exist. System security meets therequirements of the Ethics and Confidentiality Committee (ECC) of the NationalInformation Governance Board (NIGB), which has granted UCL approval undersection 251 of the NHS Act 2006 to process patient audit data (further details oninformation governance arrangements are given later).

3.3 Remit

3.3.1 NICORs initial focus is to manage six national cardiovascular clinical auditsand their associated registries (a special initiative involving the adult surgery andinterventions audits records TAVI, which can be thought of as our seventh audit).NICOR has particularly close relationships with the specialist cardiovascularsocieties (Table 1). The specialist societies provide the clinical leadership for eachregistry and audit, and most of the original datasets were developed by them.

Table 1 National clinical audits for which NICOR has responsibility from 2011Audit Patients Lead specialist society

Adult cardiac

surgery

All adult patients undergoing major heart

surgery.

Society for Cardiothoracic

Surgery (SCTS)Cardiacinterventions

All adult patients on whom a percutaneouscardiovascular intervention procedure isperformed.

British CardiovascularIntervention Society (BCIS)

Cardiacrhythmmanagement(CRM)

All adult patients with implanted devices orreceiving interventional procedures formanagement of cardiac rhythm disorders.

Heart Rhythm UK (HRUK)

Congenitalheart disease

All cardiac or intrathoracic great vesselprocedures carried out in patients under theage of 16 years, and all adult congenitalcardiac procedures performed for a cardiac

defect present from birth.

British Congenital CardiacAssociation (BCCA)


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Audit Patients Lead specialist society

Heart failure All patients with an unscheduled admissionto hospital with heart failure. British Society for HeartFailure (BSH)MINAP All adult patients with acute coronary

syndromes.British CardiovascularSociety (BCS)

TAVI All patients undergoing Transcatheter AorticValve Implantation

BCIS and SCTS

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

3.3.2 NICOR focuses on three different, but closely related, quality improvementtechniques 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 activityis funded separately and is not carried out by NICOR itself, which makes the dataavailable to applicants meeting explicit criteria. Our activities fit closely with theNCAAG advice that Clinical audit is the assessment of the process (using evidence-based criteria) and/or the outcome of care (by comparison with others). Its aim is tostimulate and support national and local quality improvement interventions and,through re-auditing, to assess the impact of such interventions(National ClinicalAudit Advisory Group 2009).

3.3.4 Clinical audit and outcomes measurement are closely related activities thatcan help to close the gap between what is known to be best care and the care thatpatients are actually receiving now. The NHS cannot improve unless it knows howpatients 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 patientsreceive the most effective, up to date and appropriate treatment, delivered byclinicians 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 questionsClinical audit and outcomes measurement can answer the key questions that

patients and clinicians ask:

Pat ients: Cl in ic ians: Answered by:

Was I given thebest care?

Did I do the right things? Clinical audit against goodpractice criteria or standards.

Has my healthimproved?

Am I helping to improvesurvival and reduce morbidity?

Clinical outcomesmeasurement.

Do I feel better? Am I helping to reduce theburden of disease?

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 - Governmentresponse to the consultation (December 2010) emphasises the role of measurementand audit in improving patient care. The Government has concluded that PatientReported Outcome Measures (PROMs), other outcome measures, patientexperience surveys and national clinical audit are not used widely enough. We willexpand their validity, collection and use. The Department will extend national clinicalaudit 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 tointroduce for the use of commissioners, providers, and patients. As one of our clinicalleads has noted, the development of new [clinical or performance] indicatorsinvolves the translation of scientifically proved interventions into explicit measurableitems of care within well-defined groups of patients. This process requires credibilityamongst clinicians and managers in order to promote collection and transmission ofappropriate data(Weston 2008). Indicators that the DH wishes to develop as part ofthe new Outcomes Framework will need just such credibility, and the national cardiacaudits, (eg, by the relevant specialist clinical societies and delivering large scaledatabases) can provide it.

3.4.3 Information for patient choice is already provided via two public portals (seeelsewhere in this document for the details). NICOR and the specialist societies arethus already delivering the kind of work described by the DHsAn InformationRevolution: a consultation on proposals, one of a series of documents publishedsubsequent to the White Paper: It is part of the Governments agenda to create arevolution for patientsputting patients first - giving people more information andcontrol and greater choice about their care. The information revolution is abouttransforming the way information is accessed, collected, analysed, and used so thatpeople 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 underfive domains. NICOR is evaluating how each NICOR audit may be used, but Table 2uses 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.1However, there are requirements on NHS organisations and individual cliniciansthat encourage participation, including:

1

Since 1989 participation in clinical audit has been mandatory for individual doctors. However, thechoice of topic and whether this is locally or nationally organised is not prescribed.
http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_120080http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_120080http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_120080http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_120080


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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 AuditPatients Outcome Programme (NCAPOP) relevant to the services (2011/12Standard Terms and Conditions for Acute Hospital Services, Gateway Reference15458).

NHS provider organisations must report on participation in four of the six auditsthat NICOR provides in their 2010/11 Quality Accounts.

Information about selected standards of care and national audit data quality isprovided on request to the Care Quality Commission (CQC). The exact nature ofwhat CQC uses in its regulatory assessments of NHS organisations varies each

year.

A new system for collecting subscription payments from NHS trusts for nationalclinical audits is being piloted.

Best Practice Tariff payments (BPTs) have been added to the Payment ByResults (PBR) system from April 2010. Although initially there are no BPTsdirectly related to NICORs cardiac audit datasets, there are two in anothercardiovascular disease. Acute trusts able to demonstrate that they met twostandards in the care of each individual stroke patient are eligible for paymentequivalent 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 directadmission and 90% of spell spent in an acute stroke unit. An NHS trust can onlyrealistically provide evidence that these standards have been achieved by takingpart in national stroke audits. Should this aspect of PBR be extended to cardiaccare, 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 theCardiac Rhythm Management audit (CRM)

The proposed domain: What CRM can offer:

1) Preventing people from dyingprematurely.

CRM reports on inequity in provision of devicesthat prolong life, and on long-term survival rates.

2) Enhancing quality of life for peoplewith long-term conditions.

Working with the other audits, we plan to developpatient-reported outcomes measures.

3) Helping people to recover fromepisodes of ill health or followinginjury.

The clinical focus on follow up of patients withimplanted devices is recorded by CRM, includingany complications.

4) Ensuring that people have apositive experience of care.

The potential exists to link CRM patient recordswith other datasets recording patient satisfaction.

5) Treating and caring for people in asafe environment and protectingthem from avoidable harm.

CRM records the safety of treatment, includingprotection 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 1April 2011. Preparing for this was a major challenge. The main elements that neededto be in place before 1 April were:

Agree the wording, deliverables and costs for the main contract between HQIPand NICOR/UCL. The contract runs from 1 April 2011 to 31 March 2014 at a costof 5.268 million.

Agree the wording, service specification and costs for the subcontract betweenNICOR/UCL (University College London) and the NHS Information Centre for the

provision of data hosting and helpdesk services. The contract runs from 1 April2011 to 31 March 2012 at a cost of 230,971 + VAT (total 277,165).

Apply for and achieve S251 approval from the Ethics and ConfidentialityCommittee 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 theTransfer of Undertakings (TUPE) process.

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


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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 cardiovasculardisease by delivering national clinical audits. To achieve our mission (as set out atthe beginning of this document) NICOR staff will aim to provide the best possiblesupport to the clinicians leading our audits. NICOR will:

Employ high quality staff to support the clinical leads with hospital liaison, datachecking, 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 andfund.

4.1.2 In more detail, NICORs objectives are to:

Identify the outcome of care: We link audit information to the date of anysubsequent deaths to identify how long patients survive after treatment. We alsolook 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 contributinghospitals, and helps them audit their systems to ensure this can be achieved.Wherever possible, we use sophisticated casemix-adjustment to ensure the truepicture is revealed in a way that standard data systems such as HES are unableto do.

Assure patients: Our reporting systems help to reassure the public that mosthospitals provide safe and effective care most of the time. For example, ourinformation is fed into public portals which patients and the public can use tocheck and compare outcomes of heart surgery and congenital heart disease careat their local hospitals. Information is also provided for NHS Choices.

Promote improvement: When results are not as they should be, we help cliniciansand managers to identify where improvements need to be made.

Link care across the patient pathway: NICOR is well placed to promote patient-focussed care for those with cardiovascular disease. Each individual audit looks

at whether the care given at a particular time met best quality standards and ledto 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 estimatingthe effect of all events on the patient, and on healthcare resources, it is crucialthat the separate audits are linked together. Quality of life for an individual patientis not just whether they received good care after their heart attack or surgery, butalso how much event free time they experience on their journey when living withheart disease.

Enable research: NICOR encourages research use of the data, with a particularfuture intention to link information about individual patients disease andtreatments across datasets to help identify not only how long they survive, butalso 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 andobjectives. 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. Someof these activities focus on supporting the specialist societies that lead each auditand 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 collectsand securely stores patient-level data, performs analyses and provides feedback tolocal NHS and national bodies such as the National Commissioning Board, DH andthe Care Quality Commission, and all within the resources available. There are otheractivities that NICOR could carry out, or liaise with others to help them carry out, thatcan 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 extraresourcing

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 tocentral 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 toexamine 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 withchanges in clinical practice.

6. Coordinate activities in support of the clinical lead (hospital liaison, contract managementmonitoring, proposal development, workshop arrangements, newsletters, etc).


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7. Advise on information governance and liaise with the governmental body that provides specialexemption 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 NationalCommissioning Board, DH, NHS Choices, CQC and MHRA.

16. Develop performance indicators which assist in benchmarking of institutions, and identifyingoutliers.

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 NationalCommissioning Board, DH, CQC and MHRA.

22. Make available validated single institution and practitioner data which will assist individualrevalidation.

23. Provide analyses or data to non-governmental bodies for non-academic purposes.

24. Provide analyses for informing NICE guidanceFeedback 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 theperformance of their local hospital.


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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 patientcare 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 whichNICOR 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 ofUCL, 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 ofa wider grouping within UCL, linked with colleagues working in prevention andeconomics, 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 JohnDeanfield 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 ofa UCL post)

Co-director of CCPO (and Deputy Cardiovascular Program Director for UCLPartners)

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 (alsoholder 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 Boardmeetings. However, proposals for the membership, meeting frequency and decision-making 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 originallydeveloped the audit datasets and which provide clinical leadership. Each of theclinical audit leads represents their audit and the professional society on the NICORExecutive and Board. NICORs structure is intended to strengthen the clinicalleadership 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 thedata and ensure that the analyses and reports address the most important issues.

5.3.2 The responsibilities of the specialist society/audit lead include specifyinganalysis criteria, revision of datasets, content and format of annual reports, reviewingapplications for access to data by external research groups, ensuring there is amechanism for the identification of outliers, future strategy and development of eachaudit, and defining and prioritising the research questions required by the specialistsociety. The audit leads are responsible for leading the delivery of the audits asrequired by the HQIP contract. They will be supported by the NICOR managementteam 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 yetto take place. In addition to a board or steering group for each audit, NICOR willneed to develop certain shared committees (Table 4). In the longer-term it may makesense to develop shared supporting committees across CCPO and, if these establishsuccessfully, then the NICOR-only committees may naturally choose to align withthese (Figure 4).

4. Proposals for the longer-term governance structure of NICOR to be put to theBoard and Executive. Lead responsible: COO. Due: September 2011.

5.4.2 Initially NICOR will either have an umbrella Academic Committee, or one foreach audit, perhaps based on the current MINAP Academic Group (MAG) model.The MAG, established in 2005, has developed a policy which sets out thegovernance framework within which the MINAP data can be shared with third partyresearch groups in a secure manner to ensure compliance with legal requirementsand NHS standards. Researchers are required to submit a detailed proposal,including the study question, specific research objectives, and the proposedanalyses 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 Remit

Overarching:

NICOR Board Strategic direction

NICOR Executive Main decision-making forum for clinical leads and staff

NICOR Management Team Operational decisions

NICOR & CCAD Staff Forum Discuss issues of concern and interest to all staff

CCPO Development Group Integrating NICOR into CCPO

CCPO Research Group Maximising opportunities for research use of audit data

NICOR Committees:

Academic Governance for data sharing [may be unnecessary duplication ofCCPO Research Group]

Audit Forum to discuss shared audit issues in more detail than Executive

Patients & Communications Patients' involvement, promoting NICOR, website, newsletter

Delivery Performance monitoring against contract deliverables

Estates Accommodation, services

Finance & Funding Budget setting and management, identifying funding sources

HR Recruitment, grading, etc

IT SLA with AISC, technical issues, options after IC subcontract ends

Policy & Governance TORs, policies, management arrangements

Strategy Scope of NICOR's work, bidding for new work

Audit Liaison Groups: Relationship and role of specialist society, clinical lead and NICOR

Cardiac Surgery As above

CRM As above

Interventions As above

Congenital As above

Heart Failure As above

MINAP As above

TAVI As above

Audit Steering Groups: Management of each audit

Cardiac Surgery As above

CRM As above

Interventions As above

Congenital As above

Heart Failure As above

MINAP As above

TAVI As above

Audit Academic Groups:

MAG (MINAP AcademicGroup)

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 ofreference for the Board, Executive and committees (Table 5). This will take t ime andmust 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 decision-making arrangements and lines of accountability. Lead responsible: committeechair. Due: within 4 weeks of committee being established.

6. A full set of necessary policies is required. Lead responsible: COO. Due: draftwithin 4 weeks of a necessary issue being identified.


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Table 5: List of NICOR terms or reference (TORs) and policies

TORs Notes

CCPO Board Drafted 8/12/10. Not yet agreed.

NICOR Drafted 12/5/09.

Other committees None yet drafted.

Policy Notes

HR NICOR will be bound by UCL policies, such as travel andsubsistence, recruitment, appraisal. Some terms & conditionsresulting from TUPE transfer are protected.

Handlingconfidentialinformation

Most of the requirements are outlined in the ECC application,and associated documents, and in the ECC response to theapplication.

Acting whendangerousperformance isidentified.

A process is required for identifying when performance ispotentially so damaging to patients that NICOR could bedeemed negligent (ethically so, even if not in law) if it did notalert those accountable for the healthcare being delivered.Guidance already in existence (eg, issued by the SCTS, andNCAAG/HQIP guidance Detection and management ofoutliers) will be considered when developing NICOR policy.

Other issues TBC

5.6 Information governance

5.6.1 NICOR must handle sensitive, confidential information about individualpatients in order to fulfil its purpose. Section 251 of the NHS Act 2006 allows thecommon law duty of confidentiality to be set aside in specific circumstances in theinterests 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 theNational Information Governance Board for Health and Social Care (NIGB) thatrecommends exemptions to the Secretary of State.

5.6.2 Our system security arrangements have met ECC/NIGB requirements, andUCL 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 frommultiple 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 practiceto hospital care and back again into the community, it is essential that allinformation related to an individual is appropriately linked. This requires a uniquepatient identifier so that further treatment episodes (including re-interventions, animportant quality indicator) are tracked.

Calculate how long patients live after different kinds of treatment, allowingclinicians and managers to identify how to improve care for patients. To do thisthe audits need to link their information with information from other data sourcesfor example, the NHS Central Register (NHSCR) for mortality tracking.

Examine socio-economic issues such as inequalities in access to services andoutcomes, by using postcode information.

In combination with other medical information, date of birth and postcode-deriveddeprivation information is used to provide risk adjustment for realistic statisticalcomparisons. These adjustments are essential to ensure that comparisons aremeaningful when providing the public with information about the safety of theirlocal services.

In addition sensitive data are held on ethnicity. This is essential as the likelihoodof some conditions, and outcomes, varies between different ethnic groupings.

5.6.3 It is important to stress that the reason why the audits collect identifiableinformation is so that the outcome of different treatments and care providers can beassessed. To do so the audits need to calculate how long a patient survives aftertreatment. A unique patient identifier must be retained so that records of treatmentcan be linked to subsequent date of death, even though this will often be years in thefuture. This allows lessons to be learnt and patient care to improve over time theprocedures that give the best survival can be promoted, and care providers whichhave significantly poorer outcomes can be identified.

5.6.4 NICORs ECC application provides details on how confidentiality is protectedwhile achieving linkage to calculate survival, the pseudonymisation processes inplace for storage of data, and the anonymisation processes for reporting. It alsodescribes the arrangements for informing patients about the use of their informationand the facility to opt out, and the circumstances in which informed consent is soughtand the process for obtaining it.

2ECC/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 CollegeLondon.


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5.7 Involving patients in our work

5.7.1 The individual audits involve patients and their representatives in severalways:

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 thatincludes a range of clinical professionals, NHS management and patientorganisations. Patients input has proved particularly valuable when selecting thedata that should be released to the public from the audit both in terms of contentand its presentation. MINAP has been highlighted as a good-practice case study(Healthcare Quality Improvement Partnership 2009). Comments by patientrepresentatives 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 tosave the lives of heart patients by encouraging hospitals and ambulanceservices to improve performances.

o To all those people who have shared in responding to the urgent needs ofall these 85,000 cases over the last twelve months, in call centres,ambulances, hospitals, clinics, surgeries and community situations, andnot forgetting the MINAP team, there are more of us surviving to tell thetale, 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 safetyof adult and paediatric heart surgeons. For example, the paediatric portal wasmodified to make navigation easier at the request of the Childrens HeartFederation.

To date the Heart Failure Audit has undertaken two patient focus groups andconsulted with patients with heart failure to identify the key issues they wouldwant addressed in an audit and audit report. Reponses coincide with those ofclinicians with regard to placing importance on accurate diagnosis and access toevidence based treatments. However patients also emphasised the importance of

3How 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 othercommunity-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 NICORsgovernance above the level of the individual audits.

7. Agree how patients and their representatives should be involved in NICORgovernance 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 cliniciansand by the national partners who use the outputs. However, the speed of auditdevelopment 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 managersand coordinators, software developers and analysts. Another factor has been thedifferent pressures and priorities on each audit that has required some to focus moreon local feedback and others on disseminating public results. NICORs establishmentis an opportunity to provide a better match of resources to needs, and to promotemore equal types and quality of outputs such as plain-language reports, publicportals, greater involvement of patients in audit governance, etc.

5.8.2 We will set out the methodological quality standards that we aspire to. Westrongly believe that clinical audit needs to be led by clinicians, because they knowwhat the most important measures are in their specialty; they collect the data duringthe clinical encounter; and they are the ones who will need to change practice ifnecessary. However, this means that clinical audit is essentially self-regulation, andpromoting it as a quality improvement tool is to grant clinicians a privilege. It followsthat NICOR, when promoting clinically-led audit, has a responsibility to help protectpatients by ensuring that each of our audits is conducted rigorously, accurately andfairly. The provision of public money obligates NICOR to provide good value formoney. 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 includingmultidisciplinary and patient representation; agreed project aims, accountabilityand decision-making arrangements; patient involvement during design andimplementation; Prince 2 or similar project management; risk register maintained;support for participants; sound information governance; delivery of contractedrequirements to time, quality and cost.

Methods: The evidence base and criteria/standards against which care ismeasured is clearly identified; data items clearly defined, appropriate sampling

(where applicable); data quality; IT; input from the multidisciplinary team and notjust 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 feedbackmechanisms; annual professional and plain language reports; data madeavailable to SHAs, commissioners, regulators; public portals and data for NHSChoices.

Improvements for patients: High participation rates (checking that all eligiblehospitals take part in the audit and submit data for the required number of casesaccurately and completely); communications; support for action planning; and a

development plan aiming towards open publication of key findings by namedlocal hospitals once data quality is mature.

8. Agree a set of quality standards for each NCOR audit; establish a system forassessing the audits against the standards and a development plan for each towork to. Lead responsible: COO with audit leads and Senior ProgrammesManager. Due: December 2011

5.9 Principles

5.9.1 NICOR intends to behave in a manner appropriate to a public sector body. Wewill endeavour to:

Always act in ways that will benefit patients and the public.

Involve patients and representative organisations in our future planning and in thegovernance arrangements of our audits.

Be open, transparent and honest in our behaviour.4

Involve in discussions, and keep informed, our principal departmental sponsorsand 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 IToperating partners.

Ensure audits involve the full multidisciplinary team.

Encourage appropriate external use of our data for research.

4We 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 GovernmentCommerce (OGC) and the Public Sector Transparency Board (which has been established in theCabinet 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 formoney.


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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 whenthose 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 outin 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 tobudget, time and quality. But NICOR is poised to achieve more for the specialistsocieties 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 Opportunities

Core auditdelivery

The six national cardiac audits Other cardiovascular audits astendering opportunities arise.

Widerdisseminationof audit data

Public portals:

Heart surgery in the UK(hosted by CQC)

Congenital heart diseaseportal (hosted by CCAD)

Analyses provided to CQC.

Analyses for NHS choices.Analyses to inform NICEguidelines

Develop public portal or NHSChoices partnership for otheraudits.

Promotingresearch byprovidingaudit data

MINAP: c.30 research projectssince 2006.

Fewer, but significant projectsassociated with other audits.

Major opportunities exist witheach of the existing audits.

OtherPartnerships

Opportunities provided by theCCPO environment and UCLPartners.

International comparisons

Stroke audit and research workwith the Royal College ofPhysicians.

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 moreaudits covering other forms of cardiovascular disease, as the contracts toprovide 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 internationalcollaborations.

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. Leadresponsible: NICOR Executive.

11.Review the benefits of further public portal websites, and identify fundingsources. 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 auditsuppliers, 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 firstquarter.

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: July2011.

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 qualitygap, NICORs analyses help identify how to bridge it. It is not possible to prove thatthe national cardiac audits have caused improvements for patients - there are toomany other factors at work. Nevertheless, there is strong anecdotal evidence thatclinician involvement in them has been one of the fundamental factors where changefor 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. Betterquality of care and outcomes are more likely to be real and sustainable whenthose most closely involved in providing the care assume leadership and

responsibility for measuring and analysing it. The Society for CardiothoracicSurgery (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, Cooperet al. 2011) and the existence of the national audit is an integral part of thisapproach. This professional desire for transparency has led to casemix-adjustedinformation being built into a website (a public portal,http://heartsurgery.cqc.org.uk) that allows patients, their GPs and the public tolook up adult cardiac surgical outcomes for their local hospital - the culminationof a main recommendation in the Bristol Inquiry Report. The SCTS believe thatopen publication has played its part in the reductions in mortality seen over theyears, with no evidence that fewer high risk patients are undergoing surgerybecause mortality rates are published (Bridgewater, Grayson et al. 2007). Inaddition to allowing patients, GPs and the public to look up adult cardiac surgical

outcomes for their local hospital, the website also provides general informationabout different operations, the benefits of having heart surgery, what to expectafter 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 providingfeedback to clinicians, it is also helping patients to ask questions about theircare, providing public reassurance where results are good, and allowingchallenge where they are not.

This focus on transparent publication of outcomes, linked to therecommendations from the Bristol Inquiry, is of course also central to theapproach of the Congenital Heart Disease Audit. Patients, parents and the public

can find information about and see the results for the different congenital heartdisease centres (http://www.ccad.org.uk/congenital). This audit holds the onlycomplete and validated database for congenital heart disease in the world.Congenital heart disease takes many different forms and there are numerousdifferent treatment procedures, making interpretation of outcome data far morecomplex than for other forms of surgery. Casemix varies considerably betweendifferent centres and between individual operators and as research continues totry to define a means of risk stratifying these treatments, survival data is currentlypresented for the mainstream specific procedures for each centre and for thenational aggregate of these specific procedures.

The Cardiac Rhythm Management CRM) audit has highlighted major under-provisiongenerally UK implantation rates are amongst the lowest in WesternEurope despite evidence refuting any difference in the prevalence of conditionsfor which implantation is indicated or the over-prescription of devices in othercountries and, benchmarked within England, After correction of device implantrates for the age and sex distribution of populations there is evidence of majorvariability or inequity of provision between PCTs which could not be explained onclinical grounds (Pacemakers and Implantable Defibrillators: A Two YearNational Survey for 2003 and 2004, Network Devices Survey Group, 2006).PCTS and cardiac networks are given detailed information about local underprovision, including maps. The report found that NICE guidance and otherpublished evidence was not always being followed, and recommended changes
http://heartsurgery.cqc.org.uk/http://heartsurgery.cqc.org.uk/http://heartsurgery.cqc.org.uk/


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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 timesdemonstrated by MINAP re-audits have achieved classic status as amongst themost high profile of all improvements demonstrated by closing the audit loop.Surviving a heart attack depends critically on how quickly treatment is givenfollowing onset of symptoms after the attack. The improvements seen each yearsince 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 riskof another heart attack (secondary prevention) are the result of actions taken by

the ambulance services, A&E departments and cardiac care units. Many extralives have undoubtedly been saved. Of course it cannot be proved that the auditwas the sole or even main reason for the trends, given that other initiatives topromote the achievement of the NSF target were happening at the same timesuch as its inclusion as a performance-managed national target in the Prioritiesand Planning Framework (PPF) 2003-2006. But most would agree thatpublicising the comparative data on performance was a fundamental spur toimprovement. In fact there are case studies in the 2007 MINAP public report thatidentify the specific role of the audit in spurring improvements. For example, oneNHS 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 therisks of the same reasons reoccurring... The number of patients having pre-hospital 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 focuson data completeness and quality can help individual hospitals understand theirplace and performance - in rapidly-changing treatment settings. Fast, reliablefeedback is essential as more heart attack patients are treated via interventionrather than with thrombolysis, with constantly changing reconfiguration as somehospitals 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 theydid not take part in the audit. But a focus on detailed, publicly available feedbackand the efforts of local clinicians to ensure their hospitals take part has led tonearly 100% participation and a high level of data completeness. Currently thereis considerable variation in both door-to-balloon and call-to-balloon times, bothmeasures of process that affect outcomes. Clear reports on where data errorsremain for each hospital prompts change. The audit provides the fast feedbackessential for those centres with poor times to identify how much better they couldbe doing they need to learn from centres that are performing well andhopefully this variance will reduce over the next few years. (National Audit ofAngioplasty 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 untilthe Heart Failure Audit began little was known about the quality of care andoutcomes for each hospital. Annual mortality analyses from the audit confirm thatthe prognosis is poor (30% at one year). Surviving patients with heart failurehave a poor quality of life, with over a third experiencing severe and prolongeddepressive illness. Yet there is good evidence that appropriate diagnosis,treatment and ongoing support can improve quality of life, help reduce morbidityand mortality and reduce hospital admission. But the audit shows that this care isoften absent and feedback to individual hospitals is opening eyes to the need toimprove (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. Thisfeedback should now prompt poorly-performing hospitals to streamline the heartfailure care pathway to ensure all patients, regardless of admission ward, haveaccess to recommended medication in line with NICE guidelines and thattreatment is managed by specialist staff.

6.2.2 The NICOR audits will continue to place an important focus on the action andimprovement that follows analysis of audit findings. Other sections have set out thedifferent audiences for which the audits produce analyses and reports, including theuse of searchable websites. We will further review the need to provide local hospitalswith 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 beyondthe 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 arelimited in the number of patients involved, exclusion criteria and the length of timeover which they are conducted. By contrast, the national cardiac audit databasescontain very large numbers of patients from most or all UK hospitals going backsome years and are much more representative of real populations:

The MINAP database contains over 840,000 patient records dating back about 10years, with 90,000 uploaded last year.

The Adult Interventions database contains details of over 460,000 PCIprocedures, 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 followingsurgery or therapeutic catheterisation.

The Heart Failure database (a comparatively new audit) has about 30,000records.

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 informationsources. For example:

HES cannot distinguish between ST elevation myocardial infarction (STEMI) andnon-STEMI patients, a distinction of fundamental importance to interpreting heartattack data in ways that can influence and improve clinical practice. MINAPallows this distinction to be made.

HES often has secondary diagnoses (comorbidities) missing. This reduces theability 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 theevidence from RCTs are being applied by clinicians in real life clinical situationsand, if not, help identify strategies to improve their use.

They can evaluate whether the guidelines are relevant to populations not coveredby the original RCTs, and assess longer-term risks (McNamara 2010).

The databases allow real life measurement of accepted clinical practice andguidelines, 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 fundingexceeding 10 million) have been undertaken using extracts of MINAP data followingapproval by the MINAP Academic Group (MAG). This research has already helped tobuild on RCT evidence, for example:5

In the period from 2004 to 2007 hospitals specialising in treating heart attacksusing primary PCI (ie, treating a high proportion with primary PCI rather thanwith thrombolytic drugs) had less delays to treatment and lower death rates

5

These interpretations reflect those of the author of this strategy document, and not necessarily thoseof 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 particularthe value of establishing heart attack centres (West, Cattle et al. 2011).

RCT evidence suggests there will be fewer deaths if patients with NSTEMI aretreated via an early invasive approach. However, in some aspects the RCTevidence is uncertain for example, as to whether women derive a similarbenefit as men. Analysis of real life MINAP data showed that women wereless likely to receive angiography, perhaps reflecting this uncertainty amongstclinicians. MINAP data showed that performance of angiography and coronaryintervention after NSTEMI was indeed associated with reduced mortality (thusconfirming the overall RCT evidence) but, importantly, also found that the

benefit was similar for both sexes. This finding should thus be able to reduceuncertainty and influence clinical practice for the better(Birkhead, Weston etal. 2009).

The MINAP database was used to investigate the impact of pre-hospitalthrombolytic treatment on re-infarction rates. The influence and interaction ofmany different variables would make such investigation hard to achieve viaRCTs. One type of drug was found to be associated with higher re-infarctionrates when used pre-hospital, although there was no difference within-hospital. The analysis also found that real-life re-infarction rates are higherthan 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 mightexperience inequitable access to cardiac services. The data revealed thatsuch patients were less likely to arrive by ambulance, but were notdisadvantaged 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 usingaudit findings to compare hospital performance as discussed elsewhere in

this document. But risk stratification is also, of course, important in the clinicalsituation to help guide appropriate decisions. For example, Patients athighest risk for adverse outcomes may derive greater benefit from the use ofeffective treatments, and this benefit may be more likely to outweigh riskinherent to certain treatments. The MINAP database has been used to testand validate five acute coronary syndrome risk scores, demonstrating that asimple 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-to-treatment 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 theworlds top 10 universities) and UCL Partners (probably bringing together the largestnumber of academic and service delivery cardiovascular clinicians and scientists inthe 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 todemonstrate 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 aboutwhether information in support of revalidation might be made available. Outputsmight promote reflection on individual and team performance. Outcomes informationis 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 Organ isatio nal stru ctur e

7.1.2 The initial posts and line management arrangements proposed to deliverNICORs 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 fromthe 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 servicespecification with the NHS IC in turn sets out helpdesk and system maintenancetimes). Despite these formal governance arrangements, we envisage that theindividual staff will work closely together in a cooperative matrix-working manner.

Figure 5: Proposed NICOR organisational structure

SUPPORT ITCLINICAL

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)

COO

AISC Group

Manager

National

Clinical Audit

Service

Manager

Senior

Clinical AuditDevelopers

Clinical Data

Auditor/

Coordinator

Senior

Analyst

Analysts

NICORNATIONAL INSTITUTE FOR CARDIOVASCULAR OUTCOMES RESEARCH

UCL.

Developer

contracts

COO

Office &

Business

Manager

Programme

Manager

Senior CCAD Strategist

Analyst

contracts

Project

Managers

Co-

ordinators

Business

Support

Officers


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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 canaccommodate about 17 people. It is not big enough to allow either co-location withother CCPO colleagues nor expansion as NICOR seeks to recruit staff and extendthe range of its work. We are actively exploring other options. Larger space will berequired within a year.

17. Identify alternative accommodation to be available from 1 April 2012. Leadresponsible: 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 thatmanaged 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 onLotus Notes. CCAD now covers many different aspects of cardiac care, offering adata 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 serversmaintained 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 bettervalue for money and greater flexibility and control.

Ensure the system is capable of dealing with increasing input both in terms ofthe number of audits and patient records, and the types and speed of outputrequired.

7.3.5 Initially carrying on an uninterrupted service, we will conduct an optionsappraisal that will consider how best to proceed, including whether re-developing viaa new application might bring benefits and make business sense.


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18. Conduct an opti

nicorstrategy.pdf

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