How to establish a National Database with some lessons from EACTS

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How to establish a National Databasewith some
lessons from EACTS theUK National Cardiac
Surgery Registries

• Dr Peter K.H. Walton
• Managing Director Dendrite Clinical Systems
• peter.walton_at_.e-dendrite.com

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My Qualifications

• Dendrite Clinical Systems is a specialist
  database supplier
• For 15 Years to gt250 Hospitals (now including
  Hong Kong)
• 45 National/International Clinical Databases
• including18 Cardiovascular Registries
  e.g.
• European Association of Cardio-Thoracic Surgery
• Society of Cardiothoracic Surgery in Great
  Britain Ireland
• Vascular Society of Great Britain Ireland
• European Society of Vascular Surgery
• European Valve Repair Group
• Société Française de Chirurgie Thoracique et
  Cardiovasculaire
• Sociedad Espanola di Cirugia Toracica y
  Cardiovascular
• Turkish Society of Cardiovascular Surgery
• Radiologia Vasculare Interventistica Sezione

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My Qualifications

• Technical Collaborator for the EACTS
• Adult Cardiac Database for the last 6 years
• Responsibilities for Data Handling for EACTS
• Providing the Central Database Engine
• Data Logic Validation Checks
• Data Importing Data Merging
• Data Analysis
• Responsibilities as the Publisher
• Report Design Assembly
• Report Production
• ISBN

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Cambridge University
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Gonville Caius College
Founded 1348
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Gonville Caius Most Famous Medic
William Harvey (1578 1657) De Motu
Cordis
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Most Famous non-Medic in Medicine
Joseph Needham (1900 1995) FRS FBA
Master of Caius 1966 - 1976 Biochemist

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Most Famous non-Medic in Medicine
Joseph Needham (1900 1995) FRS FBA
Master of Caius 1966 - 1976 Biochemist
Scientific Councellor to China 1942
Arguably the Worlds Greatest Historian of
Chinese Medicine Awarded 30 Honorary Degrees
from Chinese Universities
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Most Famous non-Medic in Medicine
Joseph Needham (1900 1995) FRS FBA
Master of Caius 1966 - 1976 Biochemist
Scientific Councellor to China 1942 Arguably
the Worlds Greatest Historian of Chinese
Medicine Awarded 30 Honorary Degrees
from Chinese Universities probably better
known in China as Li Yuese ???
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Joseph Needham
Author of 20 volumes (the history) of Science
Civilisation in China...........and is said to
have produced the greatest work of scholarship by
one person since Aristotle
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Joseph Needham
Founder of the Needham Institute
CambridgeHouses numerous Chinese treasures
including 1,400 separate chapters of an
encyclopaedia given by Dr Lu-Needham Gwei Djens
father4 resident Chinese scholars
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Joseph Needham
Founder of the Needham Institute
CambridgeHouses numerous Chinese treasures
including 1,400 separate chapters of an
encyclopaedia given by Dr Lu-Needham Gwei Djens
father4 resident Chinese scholars Visitors
always welcome http//www.nri.org.uk
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Joseph Needham is particularly Famous for
identifying the China/Europe knowledge gap
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Joseph Needham is particularly Famous for
identifying the China/Europe knowledge gap
Life of William Harvey
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Progress gap in national cardiac surgery databases
USA
Life of William Harvey
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Progress gap in national cardiac surgery databases
USA
EU
Life of William Harvey
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Progress gap in national cardiac surgery
databases ?
USA
China
EU
Life of William Harvey
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The Nuts and Bolts of How to Establish a
National Database

1. Strong Mandate
2. Careful Choice of the Database Chairman
3. Define Objectives, Roles and Responsibilities
4. Agree a Minimum Dataset
5. Appoint a Specialist Database (Company) Partner
6. Start with a Pilot to Prove Concept
7. Rollout
8. Keep the Reporting System Going

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The Nuts and Bolts of How to Establish a
National Database

1. Strong Mandate
2. Careful Choice of the Database Chairman
3. Define Objectives, Roles and Responsibilities
4. Agree a Minimum Dataset
5. Appoint a Specialist Database (Company) Partner
6. Start with a Pilot to Prove Concept
7. Rollout
8. Keep the Reporting System Going

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Strong Mandate Crossing the Rubicon
Julius Caesar - 49BC
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Strong Mandate Crossing the Rubicon

• Once you start, there is no going back
• Therefore be absolutely ready for Go
• Requires buy-in from 100 of Society Executive
• Requires planning
• Requires commitment to deliver
• Requires resolve, resources, effort
• i.e. the Strongest Mandate
• not quite an act of war.but not far off !

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The Nuts and Bolts of How to Establish a
National Database

1. Strong Mandate
2. Careful Choice of the Database Chairman
3. Define Objectives, Roles and Responsibilities
4. Agree a Minimum Dataset
5. Appoint a Specialist Database (Company) Partner
6. Start with a Pilot to Prove Concept
7. Rollout
8. Keep the Reporting System Going

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Careful Choice of Database ChairmanKey
Attributes

1. Statesman
2. Well respected
3. Safe pair of hands
4. Long term vision
5. Deliverer
6. Careful Stewardship
7. Excellent Communicator
8. Long Tenure

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Careful Choice of Database ChairmanKey
Attributes

1. Statesman
2. Well respected
3. Safe pair of hands
4. Long term vision
5. Deliverer
6. Careful Stewardship
7. Excellent Communicator
8. Long Tenure EACTS SCTSGBI

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The Nuts and Bolts of How to Establish a
National Database

1. Strong Mandate
2. Careful Choice of the Database Chairman
3. Define Objectives, Roles and Responsibilities
4. Agree a Minimum Dataset
5. Appoint a Specialist Database (Company) Partner
6. Start with a Pilot to Prove Concept
7. Rollout
8. Keep the Reporting System Going

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For example.The EACTS Database Mission
Statement

• 1. To work with other organisations towards a
• global culture of data collection to create a
• European wide repository of information on
• the practice of cardio-thoracic surgery and
• 2. To disseminate that information in such a
• way that it is easily accessible and
  understandable to the surgical community,
  patients the public.

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The UK Cardiac Surgery Database Objectives

• Systematic Data Collection of an Agreed Minimum
  Dataset
• Aggregation and Validation of Data
• Analysis and Development of Risk Stratification
  Models
• Regular Feedback to Contributing Centres
• Continuous Evaluation of Performance
• and changing practice and the influence
• of clinical risk factors

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Example Responsibilities List

• For Individual Hospitals
• Develop a Local Database
• Nominate a Link Person the Audit Lead
• Collect and Enter Data on All Patients
• Validate the Quality of the Data
• Regular Export of the Data to the National
  Registry
• Agree to Regular External Validation Checks
• ..and repeat the process of ascribing
  responsibilities
• for the Society and the database
  organisation

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The Nuts and Bolts of How to Establish a
National Database

1. Strong Mandate
2. Careful Choice of the Database Chairman
3. Define Objectives, Roles and Responsibilities
4. Agree a Minimum Dataset
5. Appoint a Specialist Database (Company) Partner
6. Start with a Pilot to Prove Concept
7. Rollout
8. Keep the Reporting System Going

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Agree adopt a minimum dataset
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What sort of data?

• Patient data
• Demographics
• Clinical History
• Risk Factors
• Investigations
• Operation/Procedural Details
• Perfusion
• Complications
• Outcomes

• ASCVS Compatible
• EACTS Compatible
• STS Compatible

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What sort of data?
One Dataset can cover multiple needs
Administration data
Research Info
Audit data
National Registry MDS
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The Nuts and Bolts of How to Establish a
National Database

1. Strong Mandate
2. Careful Choice of the Database Chairman
3. Define Objectives, Roles and Responsibilities
4. Agree a Minimum Dataset
5. Appoint a Specialist Database (Company) Partner
6. Start with a Pilot to Prove Concept
7. Rollout
8. Keep the Reporting System Going

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Careful Choice of Database PartnerKey Attributes

1. Track Record
2. Proven Data Handling Skills
3. Proven Experience with Clinical Data
4. Deliverer
5. Reliable
6. Appropriate Technology Internet capability
7. Another Safe Pair of Hands

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Dendrite Technology
Dendrite Database

• Each Hospital Agrees
• to Submit Data to a
• central Registry
• and sends a datafile

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Dendrite Technology
Dendrite Database

• Step 1 Data Submission

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Dendrite Technology
Dendrite Database

• Step 1 Data Submission
• Step 2. Import Data
• to create interim
• databases

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Dendrite Technology
Dendrite Database

• Step 1 Data Submission
• Step 2. Import Data
• to create interim
• databases
• Step 3. Correspond, run
• Validation Checks
• for Data Consistency
• and Merge Data

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Dendrite Technology
Dendrite Database

• Step 1 Data Submission
• Step 2. Import Data
• to create interim
• databases
• Step 3. Correspond, run
• Validation Checks
• for Data Consistency
• and Merge Data
• Step 4. Data Analysis,
• ( Risk Modelling)

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Data Merge Flowsheet
(from 1st EACTS Report)
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The Nuts and Bolts of How to Establish a
National Database

1. Strong Mandate
2. Careful Choice of the Database Chairman
3. Define Objectives, Roles and Responsibilities
4. Agree a Minimum Dataset
5. Appoint a Specialist Database (Company) Partner
6. Start with a Pilot to Prove Concept
7. Rollout
8. Keep the Reporting System Going

Systematic Project Planning
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The Nuts and Bolts of How to Establish a
National Database

1. Strong Mandate
2. Careful Choice of the Database Chairman
3. Define Objectives, Roles and Responsibilities
4. Agree a Minimum Dataset
5. Appoint a Specialist Database (Company) Partner
6. Start with a Pilot to Prove Concept
7. Rollout
8. Keep the Reporting System Going

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5th Adult Cardiac
Surgical Database Report

• Produced by Dendrite the SCTSGBI
• 352 Pages of analysis hard back
• 100 of National Health Service Hospitals
• gt 210,000 procedure records
• Long term survival data for CABG Valve
• patients
• 10 year data on risk factors
• 25 year trend data on activity mortality
• and different types of operations
• Volume/Outcome analysis by surgeon

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5th Adult Cardiac
Surgical Database Report

• Produced by Dendrite the SCTSGBI
• 352 Pages of analysis hard back
• 100 of National Health Service Hospitals
• gt 210,000 procedure records
• Long term survival data for CABG Valve
• patients
• 10 year data on risk factors
• 25 year trend data on activity mortality
• and different types of operations
• Volume/Outcome analysis by surgeon
• Highly regarded and valued by
• the surgical community

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Example Data Analysis from the UK Report

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Example Data Analysis from the UK Report

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Example Data Analysis from the UK Report

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Example Data Analysis from the UK Report

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5th Adult Cardiac Surgical Database
Report Detailed results by Centre
for three financial years
2001-2003 for first time isolated CABG
Focus on

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5th Adult Cardiac Surgical Database
Report Detailed results by Centre
named surgeons, hospital
results by procedure star ratings

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5th Adult Cardiac Surgical Database
Report Detailed results by Centre
named surgeons, hospital
results by procedure star ratings
Focus on Survival

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Reporting

• 3rd European Adult Cardiac Surgical Report
• Jointly Produced by EACTS / Dendrite
• Due to be Published summer 2007
• gt635,000 individual patient records
• gt250 hospitals
• 24 countries
• 14 software systems
• To be distributed free to all EACTS
• members
• To be available on EACTS website

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• Example Analysis from the 2nd EACTS
  Report

Wide variation in surgical practice across
Europe Valve surgery constitutes
16 42 casemix CABG surgery constitutes
32 78 casemix
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• Example Analysis from the 2nd EACTS
  Report

Steady increase in average age and the
proportion of patients over 75 years of age has
grown almost 3-fold from 4.8 (1994) to 18.7 in
(2003)
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Example Data Analysis from the 3rd Report

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Example Data Analysis from the 3rd Report

A cross European trend in demographic changes.
over time, an ever increasing incidence of
diabetes in the patient population
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Example Data Analysis from the 3rd Report

A wide variation in the length of stay across
Europe for the same procedure isolated CABG
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Example Data Analysis from the 3rd Report

A wide variation in the length of stay across
Europe for the same procedure isolated CABG
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In Summary - Lessons Learnt the Key to a
Successful Registry

• Appoint a highly competent database chairman
  with long tenure
• Have clear objectives for the database
• Institute an agreed minimum dataset(s)
• Appoint an experienced database specialist
  company as a partner
• Together write and execute a project plan
• Define roles and responsibilities
• Start with a simple project plan and a
  pilot programme
• Have clear deadlines and deliverables
• Demonstrate feasibility with a first data
  merge produce a report
• Develop a communications strategy to
  contributors

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How Long Does it Take to establish a national
Registry ?
Caius - Gate of Honour

• An American visitor once asked a Caius gardener
  why the lawns were so perfect?

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How Long Does it Take to establish a national
Registry ?
Caius - Gate of Honour

• An American visitor once asked a Caius gardener
  why the lawns were so perfect?
• just feed, water and roll came the answer

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How Long Does it Take to establish a
national Registry ?
Caius - Gate of Honour

• An American visitor once asked a Caius gardener
  why the lawns were so perfect?
• just feed, water and roll came the answer
  for 600 years

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How Long Does it Take to establish a
national Registry ?
Caius - Gate of Honour

• An American visitor once asked a Caius gardener
  why the lawns were so perfect?
• just feed, water and roll came the answer
  for 600 years
• Growing a high quality national database also
  takes time and patience..but you have an
  opportunity to accelerate the pace of development
  of a registry in China

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How Long Does it Take to establish a national
Registry ? - UK Example

• 1977 - Sir Terence English set up the UK Cardiac
  Surgical Register
• 1986 - The UK Heart Valve Registry was
  established
• 1990 - Society agreed a Minimum Dataset for a
  patient database
• 1996 - 1st Trial datamerge and report
  (Dendrite/Bruce Keogh)
• 1998 - Government Bristol enquiry established
• 1999 - 2nd National Adult Cardiac Database Report
  Published
• 2001 - 3rd National Adult Cardiac Database Report
  Published
• 2001 - Bristol Enquiry Report Published
• 2002 - 4th National Adult Cardiac Database Report
  Published
• 2002 - Detailed Response from DoH 198
  recommendations
• 2004 - 5th National Adult Cardiac Database Report
  Published 100 cover

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How Long Does it Take to establish a national
Registry ? - UK Example

• 1977 - Sir Terence English set up the UK Cardiac
  Surgical Register
• 1986 - The UK Heart Valve Registry was
  established
• 1990 - Society agreed a Minimum Dataset for a
  patient database
• 1996 - 1st Trial datamerge and report
  (Dendrite/Bruce Keogh)
• 1998 - Government Bristol enquiry established
• 1999 - 2nd National Adult Cardiac Database Report
  Published
• 2001 - 3rd National Adult Cardiac Database Report
  Published
• 2001 - Bristol Enquiry Report Published
• 2002 - 4th National Adult Cardiac Database Report
  Published
• 2002 - Detailed Response from DoH 198
  recommendations
• 2004 - 5th National Adult Cardiac Database Report
  Published 100 cover

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The End!
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Wishing you all a Safe Journey Home

• Questions Please