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

3. 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

4. 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

5. Dendrite Clinical Systems Ltd 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

6. Dendrite Clinical Systems Ltd 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

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 (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

8. 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

9. 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)

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

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

12. 3. National Registry Track Record Coloproctology -1 st 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.

13. 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!

14. 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)

15. 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

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

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

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

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

20. 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

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

25. 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

26. 4. National Registry Key Benefits -Risk Stratification Modelling Age 61-65 years Body Surface Area 1.70-1.89 m 2 Ejection fraction Good Priority Elective Previous operations None

27. 4. National Registry Key Benefits -Risk Stratification Modelling Age 61-65 years Body Surface Area 1.70-1.89 m 2 Ejection fraction Good Priority Elective Previous operations None Select From the Risk Factor List

28. 4. National Registry Key Benefits -Risk Stratification Modelling Age 61-65 years Body Surface Area 1.70-1.89 m 2 Ejection fraction Good Priority Elective Previous operations None See the Outcome Prediction with Confidence Limits

29. 4. National Registry Key Benefits -Risk Stratification Modelling Age 61-65 years Body Surface Area 1.70-1.89 m 2 Ejection fraction Good Priority Elective Previous operations None Patient Risk Factor Profile is Summarised Here

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

31. 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

32. 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

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:

34. 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:

35. 5. Dendrite Mechanism for National Database

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

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

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

39. 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

40. Thank you Questions Please

41. 6.Spectrum of Database Systems Available for Hospitals 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 HighLow