Marina TorreMarina Torre

Valerio Manno, Mascia MasciocchiValerio Manno, Mascia Masciocchi

Istituto Superiore di Sanità – RomaIstituto Superiore di Sanità – Roma

The EUPHORIC ProjectThe EUPHORIC Project

EFORT Congress 2008EFORT Congress 2008European Arthroplasty RegisterEuropean Arthroplasty RegisterNice, 1st June 2008Nice, 1st June 2008

SummarySummary

• The European context The European context

• Overview of the EUPHORIC projectOverview of the EUPHORIC project

• How registries might contribute?How registries might contribute?

23/09/200223/09/2002EC adopted a new Community action EC adopted a new Community action programme (6 years) for public health based programme (6 years) for public health based on 3 general objectives:on 3 general objectives:•Health informationHealth information•Rapid reactions to health threatsRapid reactions to health threats•Health promotion through addressing health Health promotion through addressing health determinantsdeterminants

The public health programme is a key element The public health programme is a key element of the “new health strategy” following the of the “new health strategy” following the introduction of specific public health introduction of specific public health provisions into the EU-Treaty of Amsterdam provisions into the EU-Treaty of Amsterdam (article 152) (02/10/1997) (article 152) (02/10/1997)

The European contextThe European contextThe Public Health Programme (2003-The Public Health Programme (2003-

2008)2008)

Developing European Union Health Developing European Union Health IndicatorsIndicators

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

ECHI (European Community Health Indicators) ECHI (European Community Health Indicators) projectproject

•Carried out in the framework of the HMP and Carried out in the framework of the HMP and the EU PHP 2003-2008the EU PHP 2003-2008

•Results: list of 'indicators' for the public Results: list of 'indicators' for the public health field arranged according to a health field arranged according to a conceptual view on health and health conceptual view on health and health determinantsdeterminants

The WP on Health IndicatorsThe WP on Health IndicatorsThe governance and the management of the The governance and the management of the overall system of EU health indicators need a overall system of EU health indicators need a specific EU Working Party assisted by a specific EU Working Party assisted by a scientific secretariat (ECHIM)scientific secretariat (ECHIM)

The European ContextThe European Context

INDICATOR = INDICATOR = a concise a concise definition of a concept meant to definition of a concept meant to provide maximal information on provide maximal information on an area of interestan area of interest

What does Indicator mean?What does Indicator mean?

EUPHORIC General ObjectiveEUPHORIC General Objective

•To define and test outcome indicators in some To define and test outcome indicators in some relevant areas of pathologyrelevant areas of pathology

•To produce protocols for data collection, To produce protocols for data collection, harmonization and analysis integrating the ECHI harmonization and analysis integrating the ECHI list list

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ParticipantsParticipants

ParticipantsParticipantsCoordinatorCoordinator• Istituto Superiore di Sanità (ISS), Rome, ItalyIstituto Superiore di Sanità (ISS), Rome, Italy

Associated BeneficiariesAssociated Beneficiaries1.1. European Arthroplasty Register, AustriaEuropean Arthroplasty Register, Austria2.2. National Research and Development Centre for Welfare and Health, FinlandNational Research and Development Centre for Welfare and Health, Finland3.3. National and Kapodistrian University of Athens, GreeceNational and Kapodistrian University of Athens, Greece4.4. Local Health Authority RM/E, ItalyLocal Health Authority RM/E, Italy5.5. Institut Municipal d’Assistencia Sanitaria, SpainInstitut Municipal d’Assistencia Sanitaria, Spain6.6. Karolinska Institutet, SwedenKarolinska Institutet, Sweden

Collaborating partnersCollaborating partners1.1. National Center of Public Health Protection, BulgariaNational Center of Public Health Protection, Bulgaria2.2. Catalan Agency for Health Technology Assessment and Research, SpainCatalan Agency for Health Technology Assessment and Research, Spain3.3. Slovak Arthroplasty Register, Slovak RepublicSlovak Arthroplasty Register, Slovak Republic4.4. Arthroplasty Register Tyrol, Austria Arthroplasty Register Tyrol, Austria 5.5. Ludwig Boltzmann Institut for Health Technology Assessment, AustriaLudwig Boltzmann Institut for Health Technology Assessment, Austria6.6. French Society of Orthopaedic and Trauma Surgery, France French Society of Orthopaedic and Trauma Surgery, France 7.7. BQS Bundesgeschäftsstelle Qualitätssicherung gGmbH, GermanyBQS Bundesgeschäftsstelle Qualitätssicherung gGmbH, Germany8.8. Israel Society for the Prevention of Heart Attacks at NCRI, IsraelIsrael Society for the Prevention of Heart Attacks at NCRI, Israel

Organisation of the projectOrganisation of the project

The project is structured in 6 Workpackages The project is structured in 6 Workpackages and organised in three phases:and organised in three phases:

• SURVEYSURVEY

• PILOTPILOT

• RESULTS DISSEMINATIONRESULTS DISSEMINATION

Results of SurveyResults of Survey

• Identification of 9 areas of diseases and of Identification of 9 areas of diseases and of 54 indicators54 indicators

• Collection of information about sources of Collection of information about sources of datadata

• Input of all the collected data in a web-Input of all the collected data in a web-based searchable DBbased searchable DB

Outcome Outcome Indicators ListIndicators List

DenominatorNumeratorTPOutcome Indicator 

Total Number of primary implantationsincluded in the evaluation sample

Number of Revisions (= exchange orremoval 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

Web-based indicators DBWeb-based indicators DB

PilotPilot

Focussing on 2 areas:

•Cardiovascular –> Acute coronary syndrome

•Orthopaedics -> Arthroplasty

Inclusion criteria:

•High political and clinical relevance

•Availability of data

Orthopaedic pilotOrthopaedic pilot1. 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

DisseminationDissemination

• Key issue for the EU Commission !!!Key issue for the EU Commission !!!

• Dissemination planDissemination plan

• Target different stakeholdersTarget different stakeholders

Dissemination toolsDissemination tools

• Web site (www.euphoric-project.eu)Web site (www.euphoric-project.eu)

• Reports (technical and not)Reports (technical and not)

• NewsletterNewsletter

How can registries contribute?How can registries contribute?

• Interoperability -> common definition of Interoperability -> common definition of variablesvariables

• Standardisation of data collectedStandardisation of data collected

• Standardisation of protocolsStandardisation of protocols

• Collection of information on comorbidities -> Collection of information on comorbidities -> risk adjustment -> comparable risk adjustment -> comparable measurementsmeasurements

• Comparison with discharge recordsComparison with discharge records

• Validation of the indicatorsValidation of the indicators

ConclusionsConclusions

• Development of a system of indicators at EU Development of a system of indicators at EU levellevel

• Registries have a relevant value both for the Registries have a relevant value both for the quantity and the quality of information quantity and the quality of information collected (not available in other sources)collected (not available in other sources)

• EUPHORIC can be a good opportunity to EUPHORIC can be a good opportunity to contribute to fill in the gap in the outcome contribute to fill in the gap in the outcome measurementsmeasurements

• Key for the successful of the implementation Key for the successful of the implementation of systematic outcome measurement in of systematic outcome measurement in Arthroplasty: close cooperation among all the Arthroplasty: close cooperation among all the involved stakeholders (public health involved stakeholders (public health institutions, scientific societies, institutions, scientific societies, manufacturers, patients) manufacturers, patients)

www.euphoric-project.eu