2007 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

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. –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 “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 My “Qualifications”

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 * Biochemist

2007 Most Famous “non-Medic” in Medicine Joseph Needham (1900 – 1995) FRS FBA * Master of Caius * 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 * 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 Lu- Needham 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 Lu- Needham Gwei Djen’s father 4 resident Chinese scholars Visitors always welcome

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 EU China Life of William Harvey

2007 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

2007 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

2007 Strong Mandate – “Crossing the Rubicon” Julius Caesar - 49BC

Once you start, there is no going back 2.Therefore be absolutely ready for “Go” 3.Requires – buy-in from 100% of Society Executive 4.Requires – planning 5.Requires – commitment to deliver 6.Requires – resolve, resources, effort 7.i.e. the Strongest Mandate not quite an act of war….but not far off ! Strong Mandate – “Crossing the Rubicon”

2007 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

Statesman 2.Well respected 3.“Safe pair of hands” 4.Long term vision 5.Deliverer 6.Careful Stewardship 7.Excellent Communicator 8.Long Tenure Careful Choice of Database Chairman Key Attributes:

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 Careful Choice of Database Chairman Key Attributes:

2007 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

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 2.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 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 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 Example “Responsibilities” List

2007 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

2007 Agree & adopt a minimum dataset

2007 What sort of data? Patient data –Demographics –Clinical History –Risk Factors –Investigations –Operation/Procedural Details –Perfusion –Complications –Outcomes ASCVS Compatible EACTS Compatible STS Compatible

2007 One Dataset can cover multiple needs What sort of data? National Registry MDS Administration data Research Info Audit data

2007 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

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” Careful Choice of Database Partner Key Attributes:

2007 Dendrite Technology Each Hospital Agrees to Submit Data to a central Registry and sends a datafile Dendrite Database

2007 Step 1: Data Submission Dendrite Technology Dendrite Database

2007 Step 1: Data Submission Step 2. Import Data to create “interim” databases Dendrite Technology Dendrite Database

2007 Step 1: Data Submission Step 2. Import Data to create “interim” databases Step 3. Correspond, run Validation Checks for Data Consistency and Merge Data Dendrite Technology Dendrite Database

2007 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) Dendrite Technology Dendrite Database

2007 Data Merge Flowsheet (from 1 st EACTS Report)

2007 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

2007 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

th 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

th 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

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

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

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

2007 Reporting 3 rd 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 2 nd 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 2 nd 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 3 rd Report

2007 A cross European trend in demographic changes………. over time, an ever increasing incidence of diabetes in the patient population Example Data Analysis from the 3 rd Report

2007 A wide variation in the length of stay across Europe for the same procedure – isolated CABG Example Data Analysis from the 3 rd Report

2007 A wide variation in the length of stay across Europe for the same procedure – isolated CABG Example Data Analysis from the 3 rd Report

2007 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

2007 An American visitor once asked a Caius gardener why the lawns were so perfect? Caius - Gate of Honour How Long Does it Take to establish a national Registry ?

2007 An American visitor once asked a Caius gardener why the lawns were so perfect? “just feed, water and roll” came the answer Caius - Gate of Honour How Long Does it Take to establish a national Registry ?

2007 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” Caius - Gate of Honour How Long Does it Take to establish a national Registry ?

2007 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 Caius - Gate of Honour How Long Does it Take to establish a national Registry ?

Sir Terence English set up the UK Cardiac Surgical Register The UK Heart Valve Registry was established Society agreed a Minimum Dataset for a patient database st Trial datamerge and report (Dendrite/Bruce Keogh) Government Bristol enquiry established nd National Adult Cardiac Database Report Published rd National Adult Cardiac Database Report Published Bristol Enquiry Report Published th National Adult Cardiac Database Report Published Detailed Response from DoH – 198 recommendations th National Adult Cardiac Database Report Published 100% cover How Long Does it Take to establish a national Registry ? - UK Example:

Sir Terence English set up the UK Cardiac Surgical Register The UK Heart Valve Registry was established Society agreed a Minimum Dataset for a patient database st Trial datamerge and report (Dendrite/Bruce Keogh) Government Bristol enquiry established nd National Adult Cardiac Database Report Published rd National Adult Cardiac Database Report Published Bristol Enquiry Report Published th National Adult Cardiac Database Report Published Detailed Response from DoH – 198 recommendations th National Adult Cardiac Database Report Published 100% cover How Long Does it Take to establish a national Registry ? - UK Example:

2007 The End!

2007 Wishing you all a Safe Journey Home Questions Please