Transcript Document

How to establish a National Database
with some lessons from EACTS & the
UK National Cardiac Surgery Registries
Dr Peter K.H. Walton
Managing Director Dendrite Clinical Systems
[email protected]
2007
My “Qualifications”
Dendrite Clinical Systems is a specialist database supplier
– For 15 Years to >250 Hospitals (now including Hong Kong) &
45 National/International Clinical Databases
including18 Cardiovascular Registries e.g.
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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 Espaňola di Cirugia Toracica y Cardiovascular
Turkish Society of Cardiovascular Surgery
Radiologia Vasculare Interventistica Sezione
2007
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
2007
Cambridge University
2007
Gonville & Caius College
Founded 1348
2007
Gonville & Caius – Most Famous Medic
William Harvey
(1578 – 1657)
“De Motu Cordis”
2007
Most Famous “non-Medic” in Medicine
Joseph Needham
(1900 – 1995)
FRS FBA
* Master of Caius 1966 - 1976
* Biochemist
2007
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 World’s Greatest
Historian of Chinese Medicine
* Awarded 30 Honorary Degrees
from Chinese Universities
2007
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 World’s Greatest
Historian of Chinese Medicine
* Awarded 30 Honorary Degrees
from Chinese Universities
probably better known in China as
Li Yuese 李约瑟
2007
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
2007
Joseph Needham
Founder of the
Needham Institute Cambridge
Houses numerous Chinese
“treasures” – including 1,400
separate chapters of an
encyclopaedia given by Dr LuNeedham Gwei Djen’s father
4 resident Chinese scholars
2007
Joseph Needham
Founder of the
Needham Institute Cambridge
Houses numerous Chinese
“treasures” – including 1,400
separate chapters of an
encyclopaedia given by Dr LuNeedham Gwei Djen’s father
4 resident Chinese scholars
Visitors always welcome
http://www.nri.org.uk
2007
Joseph Needham is particularly Famous for
identifying the China/Europe knowledge gap
2007
Joseph Needham is particularly Famous for
identifying the China/Europe knowledge gap
Life of William Harvey
2007
Progress gap in national cardiac surgery databases
USA
Life of William Harvey
2007
Progress gap in national cardiac surgery databases
USA
EU
Life of William Harvey
2007
Progress gap in national cardiac surgery databases ?
USA
China
EU
Life of William Harvey
2007
The “Nuts and Bolts” of How to
Establish a National Database
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Strong Mandate
Careful Choice of the Database Chairman
Define Objectives, Roles and Responsibilities
Agree a Minimum Dataset
Appoint a Specialist Database (Company) Partner
Start with a Pilot to Prove Concept
Rollout
Keep the Reporting System Going
2007
The “Nuts and Bolts” of How to
Establish a National Database
1.
2.
3.
4.
5.
6.
7.
8.
Strong Mandate
Careful Choice of the Database Chairman
Define Objectives, Roles and Responsibilities
Agree a Minimum Dataset
Appoint a Specialist Database (Company) Partner
Start with a Pilot to Prove Concept
Rollout
Keep the Reporting System Going
2007
Strong Mandate – “Crossing the Rubicon”
Julius Caesar - 49BC
2007
Strong Mandate – “Crossing the Rubicon”
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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 !
2007
The “Nuts and Bolts” of How to
Establish a National Database
1.
2.
3.
4.
5.
6.
7.
8.
Strong Mandate
Careful Choice of the Database Chairman
Define Objectives, Roles and Responsibilities
Agree a Minimum Dataset
Appoint a Specialist Database (Company) Partner
Start with a Pilot to Prove Concept
Rollout
Keep the Reporting System Going
2007
Careful Choice of Database Chairman
Key Attributes:
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Statesman
Well respected
“Safe pair of hands”
Long term vision
Deliverer
Careful Stewardship
Excellent Communicator
Long Tenure
2007
Careful Choice of Database Chairman
Key Attributes:
1.
2.
3.
4.
5.
6.
7.
8.
Statesman
Well respected
“Safe pair of hands”
Long term vision
Deliverer
Careful Stewardship
Excellent Communicator
Long Tenure
EACTS & SCTSGBI
2007
The “Nuts and Bolts” of How to
Establish a National Database
1.
2.
3.
4.
5.
6.
7.
8.
Strong Mandate
Careful Choice of the Database Chairman
Define Objectives, Roles and Responsibilities
Agree a Minimum Dataset
Appoint a Specialist Database (Company) Partner
Start with a Pilot to Prove Concept
Rollout
Keep the Reporting System Going
2007
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
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To disseminate that information in such a
way that it is easily accessible and understandable
to the surgical community, patients & the public.
2007
The UK Cardiac Surgery Database Objectives
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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
2007
Example “Responsibilities” List
• For Individual Hospitals
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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
2007
The “Nuts and Bolts” of How to
Establish a National Database
1.
2.
3.
4.
5.
6.
7.
8.
Strong Mandate
Careful Choice of the Database Chairman
Define Objectives, Roles and Responsibilities
Agree a Minimum Dataset
Appoint a Specialist Database (Company) Partner
Start with a Pilot to Prove Concept
Rollout
Keep the Reporting System Going
2007
Agree & adopt a
minimum dataset
2007
What sort of data?
• Patient data
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• ASCVS Compatible
Demographics
Clinical History
• EACTS Compatible
Risk Factors
Investigations
Operation/Procedural Details • STS Compatible
Perfusion
Complications
Outcomes
2007
What sort of data?
One Dataset can cover multiple needs
Administration data
Research Info
Audit data
National Registry MDS
2007
The “Nuts and Bolts” of How to
Establish a National Database
1.
2.
3.
4.
5.
6.
7.
8.
Strong Mandate
Careful Choice of the Database Chairman
Define Objectives, Roles and Responsibilities
Agree a Minimum Dataset
Appoint a Specialist Database (Company) Partner
Start with a Pilot to Prove Concept
Rollout
Keep the Reporting System Going
2007
Careful Choice of Database Partner
Key Attributes:
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Track Record
Proven Data Handling Skills
Proven Experience with Clinical Data
Deliverer
Reliable
Appropriate Technology – Internet capability
Another “Safe Pair of Hands”
2007
Dendrite
Technology
Dendrite Database
Each Hospital Agrees
to Submit Data to a
central Registry
and sends a datafile
2007
Dendrite
Technology
Dendrite Database
Step 1: Data Submission
2007
Dendrite
Technology
Dendrite Database
Step 1: Data Submission
Step 2. Import Data
to create “interim”
databases
2007
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
2007
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)
2007
Data Merge Flowsheet (from 1st EACTS Report)
STS
40
EACTS
35
% women
30
25
20
15
10
5
0
1995
1996
1997
1998
1999
2000
2001
2002
2003
Procedure year
2007
The “Nuts and Bolts” of How to
Establish a National Database
1.
2.
3.
4.
5.
6.
7.
8.
Strong Mandate
Careful Choice of the Database Chairman
Define Objectives, Roles and Responsibilities
Agree a Minimum Dataset
Appoint a Specialist Database (Company) Partner
Start with a Pilot to Prove Concept
Rollout
Keep the Reporting System Going
2007
The “Nuts and Bolts” of How to
Establish a National Database
1.
2.
3.
4.
5.
6.
7.
8.
Strong Mandate
Careful Choice of the Database Chairman
Define Objectives, Roles and Responsibilities
Agree a Minimum Dataset
Appoint a Specialist Database (Company) Partner
Start with a Pilot to Prove Concept
Rollout
Keep the Reporting System Going
2007
5th Adult Cardiac
Surgical Database
Report
* Produced by Dendrite & the SCTSGBI
* 352 Pages of analysis – hard back
* 100 % of National Health Service Hospitals
* > 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
2007
5th Adult Cardiac
Surgical Database
Report
* Produced by Dendrite & the SCTSGBI
* 352 Pages of analysis – hard back
* 100 % of National Health Service Hospitals
* > 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
2007
Example Data Analysis from the UK Report
2007
Example Data Analysis from the UK Report
2007
Example Data Analysis from the UK Report
2007
Example Data Analysis from the UK Report
2007
5th Adult Cardiac Surgical Database Report
Detailed results by Centre for three financial
years 2001-2003 for first time isolated CABG
Focus on
2007
5th Adult Cardiac Surgical Database Report
Detailed results by Centre – named surgeons,
hospital results by procedure + star ratings
2007
5th Adult Cardiac Surgical Database Report
Detailed results by Centre – named surgeons,
hospital results by procedure + star ratings
Focus on
Survival
2007
Reporting
3rd European Adult Cardiac Surgical Report
Jointly Produced by EACTS / Dendrite
Due to be Published summer 2007
>635,000 individual patient records
>250 hospitals
24 countries
14 software systems
To be distributed free to all EACTS
members
To be available on EACTS website
2007
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
2007
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)
2007
Example Data Analysis from the 3rd Report
2007
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
2007
Example Data Analysis from the 3rd Report
A wide variation in
the length of stay
across Europe for
the same procedure
– isolated CABG
2007
Example Data Analysis from the 3rd Report
A wide variation in
the length of stay
across Europe for
the same procedure
– isolated CABG
2007
In Summary - Lessons Learnt:
the Key to a Successful Registry
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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
2007
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?
2007
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
2007
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”
2007
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
2007
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
2007
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
2007
The End!
2007
Wishing you all a Safe Journey Home
Questions Please
2007