Establishing a national cardiac surgical database:

Chinese Association of Cardiovascular Surgeons 2007

Establishing a national cardiac

surgical database:

Insights from the UK & Europe

Bruce E Keogh


What is healthcare data used for?

• Policy planning• Performance assessment

– Health Authorities– Hospitals– Specialties– Consultants

• Governance• Research• Audit• Public and patient information


The value of national databases

• Benchmarking of national standards– Institutional quality assurance

• Trends in practice– Anticipate financial impact

• Risk models for performance monitoring

• International comparisons



Cost of CABG related to Mortality Ratio


Cardiac Surgical Data Collection in the UK

1975 1980 1985 1990 1995 2000 2005

?

UK Cardiac Surgical Register

UK Heart Valve Registry

Adult Cardiac Database

Central Cardiac Audit Database



1975 1980 1985 1990 1995 2000 2005

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UK Cardiac Surgical RegisterUnit Activity & mortality250 Adult categories200 Congenital categoriesAggregated results returned to units


Activity and mortality trends for isolated

coronary surgery (n=386,745)

0

4

8

12

16

20

24

28

Year

Thousa

nds

of oper

atio

ns

0%

1%

2%

3%

4%

5%

6%

7%

Cru

de m

ortality rate


Activity and mortality trends for combined heart valve and coronary bypass surgery

0

1

2

3

4

5

Year

Thousa

nds

of oper

atio

ns

7%

9%

11%

13%

15%

17%

Cru

de m

ortality rate



1975 1980 1985 1990 1995 2000 2005

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UK Heart Valve RegistryValve replacements onlyFew patient & valve variablesMortality Tracking


Long term survival following valve replacement in the UK

0

10

20

30

40

50

60

70

80

90

100

Years following implant

Su

rviv

al (

%)

Aortic Mitral Tricuspid

UK Heart Valve Registry, 2003

N= 87,343 patients


The need for national clinical databases

Malpractice / Clinical Governance

Changing patient profile

JCAHCO / AccreditationBoard Accreditation / CME

United States

Health Care Financing Administration

Raw Data

STS Standards & EthicsCommittee

“Statement of Concern”

Society Driven National database

United Kingdom

Internal MarketPurchaser / Provider

Raw data

SCTS Executive Committee

“Database Project”

Society Driven National database


Change in politics



1975 1980 1985 1990 1995 2000 2005

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National Adult Cardiac Surgical DatabaseAll adult cardiac surgery150 data-pointsVoluntary


Developing the database: McNamara’s conundrum

President Ford Motor Company (1960)8th US Secretary of Defence (1961-8)President of the World Bank (1968-81)

“Do you make what is measurable importantor…Do you make what is important measurable?”


The Measurement of Outcome

• Not easy to measure outcomes for all specialties• No perfect risk algorithm for any intervention or

treatmentInfluenced by:• Differing thresholds of referral / acceptance• Age• Severity of illness• Standard of surgery or intervention• Overall standard of institutional care

– Diagnosis, treatment and clinical management


The first step: Define an outcome

• Potential Clinical Outcomes– Mortality– Near miss– Length of stay– Reoperation– Other morbidities

• Best practice– Discharge drugs– Communication

• Simple to measure

• Easily acquired• Easily validated• Understandable• Relevant• Robust


The second step: A meaningful dataset

• Clinically relevant, defined dataset– Simple– Adequate contemporary risk stratification– Surveillance– Anticipates change


The UK National Adult Cardiac Surgical Database: Minimum Dataset

Patient Data• Demographics• Cardiac history• Co-morbidities• Preoperative

investigations• Preoperative support

Operative Data• Operative priority• Procedure data• Training data

Outcome Data• Complications• Mortality


Is more data better?

0.5

0.55

0.6

0.65

0.7

0.75

0.8

RO

C

Most prediction from the first 5-7 variables


Risk factor influence changes with time:Evolution of STS Risk Factors

0 1 2 3 4 5 6 7 8

Age>70

Emegency

Ejection fraction

Left main stem disease

Renal impairment

Female Gender

3-vessel disease

COAD

Redo surgery

Cerebrovascular disease

Peripheral vascular disease

Smoking

Hypertension

Ris

k f

act

or

Odds ratio

1980's

2000


Risk Stratification Systems

• Some basic variables– Type of operation– Age, Gender, Re-operation, Urgency– Cardiac function, recent MI– Comorbidities: diabetes, hypertension, etc

• Score allocated to each variable• Simple additive systems

– Parsonnet Score, EuroSCORE

• Complex statistical systems– Logistic regression, Bayesian modelling


1 2 3 4 5 6

Different risk models use different variables

EJTCVS 2000;17:400-6

AgeLV functionReoperationRenal function


Lessons learned from the dataset

• Keep the dataset simple

• Define clear definitions immediately

• Anticipate future changes

• Post-operative complications are difficult to collect well


Accuracy of data depends on use

• Professionally credible– Specialty input

• Publicly credible– Independent

Accuracy & reliability

International Institutional Individual


Why is Validation Necessary?

Risk factor variation in New York:Before and after report cards

COAD

Unstable angina

Year 1

1.8%

1.9%

Year 2

52.9%

20.8%

Range

1.4 - 61%

0.7 - 61.4%

New York DoH spends 3 years validating data before release


The importance of data quality & validation

BMJ Jan 2003


Lessons on data quality

• Decide a strategy for data validation– Define local data checking processes for all

participating hospitals– External visits are best, but may be difficult with

data protection laws


Fifth National Adult Cardiac Surgical Database ReportSeptember 2004

256 pagesEvolving quality improvement initiativesThe UK Cardiac Surgical RegisterThe UK Heart Valve RegistryThe Cardiac Surgical DatabaseUnit results for CABG & AVRUnit risk factor profilesUnit missing dataIndividual surgeon analyses





1975 1980 1985 1990 1995 2000 2005

?





National Adult Cardiac Surgical DatabaseAll adult cardiac surgery150 data-pointsMandatoryLong term mortality tracking


The Central Cardiac Audit Database

National Clinical Audit Support Programme

Harmonised datasetsData collection

ONS

Specialty Disease CCAD Specialty Disease

Adult cardiac CongenitalMINAP AngioplastyAmbulance

Healthcare Commission


The Central Cardiac Audit Database

Secure CCAD server

Operating theatres

Hospital clinical database

Dendrite &NICOR at UCL

Encryption & Internet transmission

Office of National Statistics

Reports & research


Mortality rates for surgery in the UK

30 days 1 year 5 years

CABG 1.9% 3.9% 11.1%

Valve 3.4% 7.1% 20.1%

CABG + 5.8% 11.5% 24.3%Valve

Other 9.9% 16.3% 28.1%


The National Adult Cardiac Surgical Database: Long-term follow up for a single hospital


Survival after Isolated Aortic Surgeryin patients aged 80+: Influence of pulmonary disease

No lung disease COPD/emphysema/asthma

Discharge 96.7% 75.7%

1 year 90.6% 69.6%

2 years 88.9% 54.9%

5 years 63.6% 20.0%

Central Cardiac Audit Database: Unpublished data


Emerging linkages

Secure CCAD National server

NICOR at University College London

Office of National Statistics

Reports

National NHS administrative data

Commercial databasesMosaic• Social demographics• Financial demographics• Food & purchasing


Define a data analysis and access policy

• Where will data be stored?

• Who can have access?

• Who checks quality of analysis?

• Who authorises publication?

All who submit data should have access in some way


Data oversight in the UK

Funding & Enforcement

DH Departmentof Health


ProfessionalStandards & reports


National Institute for Clinical Outcomes Research (NICOR)

Principles• To provide Independent analysis of clinical

data• Answerable to:

– Clinical Specialist Associations– Healthcare regulator– Department of Health

• Provision of data to major partners


Analytical Support TeamProf Roger BoyleProf Adam TimmisProf Ken TaylorDr John BirkheadMr Ben BridgewaterDr David CunninghamDr John GibbsDr Peter LudmanMr James Roxburgh

CCAD Technical team

Board of Directors

Departmental Head

Project manager

MINAP BCIS SCTS Paediatrics HVR

AnalystsData management

AnalysesReport writing

Support TeamData qualityUsersData managersWorkshopsNewsletters

UCL Senior Lecturer(Statistics)

Ambulance

Health & Social CareInformation Centre


Circulation 2005;112:224-31


What could we have done better?

• Dataset– Clear definitions from the start– Agreement on how to change the dataset

• Shared ownership of data– Early collaboration with others

• Hospital administration• Health Authority• Regulators

– Integrate with hospital data systems


In summary

There will be increasing healthcare regulation with increasing transparency of data.

A national clinical database will facilitate:• Analysis of trends in practice • Benchmarking of national standards

– Institutional and personal

• Risk models for performance monitoring• International comparisons Surgeons & institutions should take the initiative


Where to next?

• Additional quality indicators– National Quality Forum– Canadian Consensus Panel– Annals of Thoracic Surgery April 2007

• Linkage to other national data sources

• Documentation of training

• Maintenance of certification


Why collect European data?

European Union

Strength in numbers, politically & statistically Strength through shared data Strength through supra national support

Changing clinical practice Increasing national & EU regulation

EACTS Congenital Database ESTS Thoracic Surgery Database EACTS adult cardiac Surgery Database


Gathering evidence: What sort of data?

• National demographics – population, age, national SMRs etc.

• How many institutions in each country?

• How many operations in each country?

• Patient data– Demographics– Outcomes


Gathering evidence: A meaningful dataset

• Patient Data• Demographics• Cardiac history• Co-morbidities• Preoperative

investigations• Preoperative support

• Operative Data• Operative priority• Procedure data• Training data• Outcome Data• 3 Complications• Survival

Harmonised with STS and UK but smaller

EACTS Adult Cardiac Surgical Database Dataset


Process & Methodology:How to collect data across Europe

Hospital direct• Considerable communication• Unclear authority• Ownership unclear

High cost, high risk

Via national associations• Less communication• Clear lines of authority• Nationally owned• Data cleaner• Reproducible model

Low cost, low risk


Process & Methodology :The preferred option

Institution

Country(Specialist Association)

EACTS Adult Cardiac

Consultative, Comparative analysis

Direct submission EACTS Congenital Database ESTS Thoracic Surgical Database


Reporting

3rd European Adult Cardiac Surgical Database Report Jointly Produced by EACTS / Dendrite

To be published October 2007

As a “Demonstration” Report with data

631,000 patient records

> 250 hospitals

22 countries

> 20 software systems

Distributed free to all EACTS members

Delegates at the 2007 EACTS meeting in Geneva

Available on EACTS website


EACTS Adult Cardiac Surgical Database - progress

• STREAM 1 (2002 - 5)– Defined and agreed dataset– Downloading and merging of data– Some analysis– Establish mechanism of joint governance with national

associations• STREAM 2 (2006 - 2010)

– EU funding for EACTS & contributing associations– Validation– Refine analysis & presentation

• STREAM 3– Specific projects

Achiev

ed

Achiev

ed


Thank you

Documents

Establishing a national cardiac surgical database: