Dr Stefano Passani Associate Health Management Director Dendrite Clinical Systems Ltd stefano.passani@e-dendrite.com Cli

1. Dr Stefano Passani Associate Health Management Director Dendrite Clinical Systems Ltd stefano.passani@e-dendrite.com Clinical Outcomes Measurement

2. Agenda – Measuring Clinical Outcomes • 1. Benefits of Measuring Outcomes • 2. Who is Dendrite? • 3. National Registry Track Record • 4. Benefits of a National Registry • 5. Dendrite “Mechanism” for a National Registry • 6. Questions & Answers

3. Benefits of Measuring Outcomes • Providing Aggregate Trend Data and Variance Analysis • Develop Risk Stratification Models • Benchmark Outcomes Against National Standards Adjusting for Co-morbidity, Casemix and Risk Stratification • Monitor Outcomes of Trainees • Follow-up medium & long term outcome of care • Provide a New Model for Internal & External Negotiations • Guide Clinical Practice Towards Best Outcome

4. How to Motivate Data Collection? • Build Data Collection into Daily Work • Data Collection Must be Prospective: collect as you go: clinical care process mapping • Build in Benefits to Data Collection • Automated Clinical Admin. Reports • Automated Audit • Enhanced Decision Making • Comparative Analysis • Automated Log Books Dendrite Clinical Systems Ltd

5. Caveats • Accuracy – Completeness - Gaming • “My patients are always the sickest” • “Transfers with unknown outcomes” • Problems with Objectivity • e.g. Measuring Pain Levels • Observer Bias! • Problems with Interpretation • Dataset Definitions e.g. When is a Death a Death? - the 30 day rule Dendrite Clinical Systems Ltd

6. 2. Who is Dendrite? • Private British Medical Software Company • 10th Year of Trading • Supplier of Clinical Information Systems for Hospitals • > 250 Hospitals in 28 Countries • > 100 Hospitals in the UK (NHS & Private) • Supplier of National Registry Software • > 35 National & International Registries (in particular interventions, device registries & rare diseases) • Specialist in Risk Modelling Consultancy & Comparative Outcome Analysis Reporting • Medical Publisher • National Registry Reports

7. 2. Who is Dendrite? • Private British Medical Software Company • 10th Year of Trading • Supplier of Clinical Information Systems for Hospitals • > 250 Hospitals in 28 Countries • > 100 Hospitals in the UK • Supplier of National Registry Software • > 35 National & International Registries (in particular interventions, device registries & rare diseases) • Specialist in Risk Modelling Consultancy & • Comparative Outcome Analysis Reporting • Medical Publisher • National Registry Reports

8. 3. National Registry Track Record Cardiothoracic Surgery • Data Harvest • Data Import • Data Merge • Data Analysis • Risk Modelling • Report Production “The most comprehensive documentation available in the UK on Cardiac Surgery” Dr Roger Boyle (National Director for Heart Disease)

9. 3. National Registry Track Record Vascular Surgery • Data Harvest • Data Import • Data Merge • Data Analysis • Risk Modelling • Report Production Now on 3rd Report – published in April 2003

10. 3. National Registry Track Record Interventional Radiology • Data Harvest • Data Import • Data Merge • Data Analysis • Risk Modelling • Report Production 1st Report on Iliac Angioplasty 2nd Report due on Oesophageal Stents Inserted by Radiologists

11. 3. National Registry Track Record Coloproctology • 1st Report was a reworking of existing data collected at the Royal College of Surgeons. • Dendrite Imported the Data, ran new analyses & constructed Bayes risk stratification models. From next Year Dendrite will be providing the central registry data harvest and analysis service.

12. 3. National Registry Track Record Illustrative not Definitive • Limited Data • Not National • No External Data Validation • Limited Analysis But it does demonstrate: • Dendrite’s Merge Capability Dendrite/ASCOT/Access Data • Some Useful Analyses • Early Risk Modelling • The Overall Process Works!

13. 3. National Registry Track Record Other Examples of Regional, National & International Registries that use Dendrite Software: • Neurosurgery CSF Shunt Registry (Addenbrooke’s) • UK Heart Valve Registry (Hammersmith) • West Midlands Intensive Care Registry (QE Birmingham) • European Sickle Cell Registry (Central Middlesex) • UK Gaucher’s Disease Registry (Addenbrooke’s) • Czech Republic National Renal Transplant Registry (Prague) • South West London Vascular Network Registry (St George’s) • National VTE Treatment Registry (Aventis Pharma)

14. 3. National Registry: the lessons learned so far… Population-based, longitudinal study-ies, including big numbers which allow relatively quick assembly of risk models with weighting of risk factors. Risk – adjustment methodologies allow the true comparison of Departments’ work across the board Migrating risk- adjustment methods from one to an other clinical areas is safe

15. PATS Database Structure Clinical History & Examination Investigations Treatment/Operations Outcomes - Morbidity/Mortality Collect Clinical Data Enter Data into Database Analyse & Data and Produce Automated Audit Reports Core Data National & International Clinical Registries Correspond Core Data to Internal Database Risk Models

16. PATS Database Structure PAS Labs PATS Database Patient Demographic Information PAS-Link ORIC Lung Cancer Registry Breast Cancer Registry Follow-Up Follow-Up Follow-Up Follow-Up Follow-Up Follow-Up

17. Economies of Scale Cardiac Surgery Neuro Surgery Surgical Oncology Diabetes

18. Data Capture & Data Entry Options Dynamic Data Exchange Links to/from 3rd Party Databases Using ODBC and/or HL7 Protocol Optical Character Recognition Fax/Scanner Local Keyboard Terminal Wireless Touch Screen Device

19. The PATS Spectrum of Use • Uses:- • Clinical Workstation / Automated Reports • PAS & Images-Result Database - Link • Data Analysis / Audit Reports / Outcome Tracking • Quality Assurance / TQM / Runs Analysis • Risk Stratification / Severity Scoring • Clinical Care Path Variance Analysis • Critical Incident Tracking / Risk Management • Decision Analysis at the Point-of-Care • Benchmarking Performance against National Standards • Clinical Governance

20. 4. National Registry Key Benefits • Trend Analysis

21. 4. National Registry Key Benefits • Trend Analysis

22. 4. National Registry Key Benefits • Trend Analysis

23. 4. National Registry Key Benefits • Trend Analysis

24. 4. National Registry Key Benefits • Trend Analysis • Provides an Observational Record of Demographic Changes • Empowers Discussions with Government & Commissioners of Care • Provides a Benchmark for Outcomes

25. 4. National Registry Key Benefits • Risk Stratification Modelling Age 61-65 years Body Surface Area 1.70-1.89 m2 Ejection fraction Good Priority Elective Previous operations None

26. Select From the Risk Factor List 4. National Registry Key Benefits • Risk Stratification Modelling Age 61-65 years Body Surface Area 1.70-1.89 m2 Ejection fraction Good Priority Elective Previous operations None

27. See the Outcome Prediction with Confidence Limits 4. National Registry Key Benefits • Risk Stratification Modelling Age 61-65 years Body Surface Area 1.70-1.89 m2 Ejection fraction Good Priority Elective Previous operations None

28. Patient Risk Factor Profile is Summarised Here 4. National Registry Key Benefits • Risk Stratification Modelling Age 61-65 years Body Surface Area 1.70-1.89 m2 Ejection fraction Good Priority Elective Previous operations None

29. 4. National Registry Key Benefits • Risk Stratification Modelling • Point-of-Care Decision Support • Improved Assessment of Risks for Patient Consent

30. 5. National Registry Benefits • Risk Stratification Modelling • Point-of-Care Decision Support • Improved Assessment of Risks for Patient Consent • Single Page Appraisal of Performance Reports: Actual Outcome v. Risk Adjusted Expected Outcome per Procedure Type

31. 4. National Registry Benefits CHI Perspective – Clinical Governance Review “Vascular services take part in the national pilot database, which provides risk adjusted outcome information. There is a desire within the Trust to utilise a system such as this for the whole organisation. CHI would encourage the Trust to take these steps” June 2002

32. 4. National Registry Key Benefits • Risk Stratification Modelling • Point-of-Care Decision Support • Improved Assessment of Risks for Patient Consent • Single Page Appraisal of Performance • Allows for Proper Prospective Audit, to Compare Observed Actual Outcome with Expected Risk Stratified Outcome over Time - CUSUM:

33. 4. National Registry Key Benefits • Risk Stratification Modelling • Point-of-Care Decision Support • Improved Assessment of Risks for Patient Consent • Single Page Appraisal of Performance • Allows for Proper Prospective Audit, to Compare Observed Actual Outcome with Expected Risk Stratified Outcome over Time - CUSUM + C.I.s:

34. 5. Dendrite Mechanism for National Database

35. 5. Dendrite Mechanism for National Database Step 1: Harvest Data

36. 5. Dendrite Mechanism for National Database Step 1: Harvest Data Step 2. Import Data to create “interim” databases

37. 5. Dendrite Mechanism for National Database Step 1: Harvest Data Step 2. Import Data to create “interim” databases Step 3. Correspond, run Validation Checks for Data Consistency and Merge Data

38. 5. Dendrite Mechanism for National Database Step 1: Harvest Data Step 2. Import Data to create “interim” databases Step 3. Correspond, run Validation Checks for Data Consistency and Merge Data Step 4. Data Analysis, Outcome Analysis & Risk Modelling

39. Thank you Questions Please

40. £ 6.Spectrum of Database Systems Available for Hospitals High Low Dendrite Fully Flexible  Multi-specialty  PAS Links  Lab Links  Data Analysis  Outcome Analysis  Risk Modelling  Other Proprietary Semi Rigid Database Multi-specialty ?? PAS Links Lab Links ?? No Analysis No Outcome Analysis No Risk Modelling MS Access - BASO Rigid Database Single Specialty PAS Links ?? No Data Analysis No Outcome Analysis No Risk Modelling