1. Marina Torre Valerio Manno, Mascia Masciocchi Istituto Superiore di Sanità – Roma The EUPHORIC Project EFORT Congress 2008 European Arthroplasty Register Nice, 1st June 2008

2. Summary The European contextThe European context Overview of the EUPHORIC projectOverview of the EUPHORIC project How registries might contribute?How registries might contribute?

3. 23/09/2002 EC adopted a new Community action programme (6 years) for public health based on 3 general objectives: Health informationHealth information Rapid reactions to health threatsRapid reactions to health threats Health promotion through addressing health determinantsHealth promotion through addressing health determinants The public health programme is a key element of the “new health strategy” following the introduction of specific public health provisions into the EU-Treaty of Amsterdam (article 152) (02/10/1997) The European context The Public Health Programme (2003-2008)

4. Developing European Union Health Indicators European Commission's aim: to produce comparable information on health and health-related behaviour of the population, and on diseases and health systems By means of common indicators agreed Europe-wide on the definition, collection and use of such information. Actions supported by the Programme of Community Action in the Field of Public Health (2003-2008) were related to the development of indicators, leading to recommendations either for indicators for various health fields or for improvements in the collection of data relating to these indicators

5. ECHI (European Community Health Indicators) project Carried out in the framework of the HMP and the EU PHP 2003-2008Carried out in the framework of the HMP and the EU PHP 2003-2008 Results: list of 'indicators' for the public health field arranged according to a conceptual view on health and health determinantsResults: list of 'indicators' for the public health field arranged according to a conceptual view on health and health determinants The WP on Health Indicators The governance and the management of the overall system of EU health indicators need a specific EU Working Party assisted by a scientific secretariat (ECHIM) The European Context

6. INDICATOR = a concise definition of a concept meant to provide maximal information on an area of interest What does Indicator mean?

7. EUPHORIC General Objective To define and test outcome indicators in some relevant areas of pathologyTo define and test outcome indicators in some relevant areas of pathology To produce protocols for data collection, harmonization and analysis integrating the ECHI listTo produce protocols for data collection, harmonization and analysis integrating the ECHI list

8. 1 1 3 1 1 1 1 11 2 2Participants

9. Participants Coordinator Istituto Superiore di Sanità (ISS), Rome, ItalyIstituto Superiore di Sanità (ISS), Rome, Italy Associated Beneficiaries 1.European Arthroplasty Register, Austria 2.National Research and Development Centre for Welfare and Health, Finland 3.National and Kapodistrian University of Athens, Greece 4.Local Health Authority RM/E, Italy 5.Institut Municipal d’Assistencia Sanitaria, Spain 6.Karolinska Institutet, Sweden Collaborating partners 1.National Center of Public Health Protection, Bulgaria 2.Catalan Agency for Health Technology Assessment and Research, Spain 3.Slovak Arthroplasty Register, Slovak Republic 4.Arthroplasty Register Tyrol, Austria 5.Ludwig Boltzmann Institut for Health Technology Assessment, Austria 6.French Society of Orthopaedic and Trauma Surgery, France 7.BQS Bundesgeschäftsstelle Qualitätssicherung gGmbH, Germany 8.Israel Society for the Prevention of Heart Attacks at NCRI, Israel

10. Organisation of the project The project is structured in 6 Workpackages and organised in three phases: SURVEYSURVEY PILOTPILOT RESULTS DISSEMINATIONRESULTS DISSEMINATION

11. Results of Survey Identification of 9 areas of diseases and of 54 indicatorsIdentification of 9 areas of diseases and of 54 indicators Collection of information about sources of dataCollection of information about sources of data Input of all the collected data in a web-based searchable DBInput of all the collected data in a web-based searchable DB

12. Outcome Indicators List DenominatorNumeratorTPOutcome Indicator Total Number of primary implantations included in the evaluation sample Number of Revisions (= exchange or removal of at least a part of the implant) at follow-up period X **REVISION RATEE8 DefinitionDefinition RationaleRationale NumeratorNumerator DenominatorDenominator Statistical methodsStatistical methods How to use itHow to use it ReferencesReferences

13. Web-based indicators DB

14. Pilot Focussing on 2 areas: Cardiovascular –> Acute coronary syndrome Orthopaedics -> Arthroplasty Inclusion criteria: High political and clinical relevance Availability of data

15. Orthopaedic pilot 1.A systematic review of all arthroplasty Registers in Europe and related projects 2.A systematic review of outcome registers in Sweden and Finland 3.An extended literature research concerning the value of different data sources (Registers, meta-analyses of clinical studies, surveys,..) for outcome research in arthroplasty. 4.An analysis concerning the value of existing instruments (Registers, public health implant failure and monitoring institutions), surveillance by the manufacturers and other datasets (clinical literature) concerning the detection of inferior outcome. 5.A report on specific requirements for outcome measurement from statistical point of view. 6.A proposal for a quality label system for the datasets and information to be used in indicators computing

16. Dissemination Key issue for the EU Commission !!!Key issue for the EU Commission !!! Dissemination planDissemination plan Target different stakeholdersTarget different stakeholders Dissemination tools Web site (www.euphoric-project.eu)Web site (www.euphoric-project.eu) Reports (technical and not)Reports (technical and not) NewsletterNewsletter

17. How can registries contribute? Interoperability -> common definition of variablesInteroperability -> common definition of variables Standardisation of data collectedStandardisation of data collected Standardisation of protocolsStandardisation of protocols Collection of information on comorbidities -> risk adjustment -> comparable measurementsCollection of information on comorbidities -> risk adjustment -> comparable measurements Comparison with discharge recordsComparison with discharge records Validation of the indicatorsValidation of the indicators

18. Conclusions Development of a system of indicators at EU levelDevelopment of a system of indicators at EU level Registries have a relevant value both for the quantity and the quality of information collected (not available in other sources)Registries have a relevant value both for the quantity and the quality of information collected (not available in other sources) EUPHORIC can be a good opportunity to contribute to fill in the gap in the outcome measurementsEUPHORIC can be a good opportunity to contribute to fill in the gap in the outcome measurements Key for the successful of the implementation of systematic outcome measurement in Arthroplasty: close cooperation among all the involved stakeholders (public health institutions, scientific societies, manufacturers, patients)Key for the successful of the implementation of systematic outcome measurement in Arthroplasty: close cooperation among all the involved stakeholders (public health institutions, scientific societies, manufacturers, patients)

19. www.euphoric-project.eu