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Nationella kvalitetsregister NORDIC COLLABORATIONS ON REGISTRIES

Nationella kvalitetsregister NORDIC COLLABORATIONS ON REGISTRIES. Tina Lidén Mascher R.N., Degree in physioth ., MBA Strateg industrisamverkan och internationella projekt Nationella Kvalitetsregister Sveriges Kommuner och Landsting 118 82 Stockholm Besök: Hornsgatan 20 +46 8 452 71 75

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Nationella kvalitetsregister NORDIC COLLABORATIONS ON REGISTRIES

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  1. Nationella kvalitetsregisterNORDIC COLLABORATIONS ON REGISTRIES Tina Lidén Mascher R.N., Degree in physioth., MBA Strateg industrisamverkan och internationella projekt Nationella Kvalitetsregister Sveriges Kommuner och Landsting 118 82 StockholmBesök: Hornsgatan 20 +46 8 452 71 75 +46 76-526 90 71 kristina.lidenmascher@skl.se http://www.kvalitetsregister.se/industrisamverkan www.kvalitetsregister.se Twitter: @kvalitetsregist

  2. Exempel på pågående projekt i Norden • Barncancer: solida tumörer och CNS-tumörer, Norden och Litauen • Cancer lever, gallblåsa: gemensamma kvalitetsindikatorer, Danmark (standardiserat vårdförlopp), Norge, Sverige • Katarakt: Danmark, Sverige • Hemofili: Förstudie för etablering av registret, aktuell praxis i de nordisk länderna • Infcare: Island • MS: samordning mellan svensk och dansk MS-vård • NORDCAN (Cervixcancer): mjukvaran NORDCAN som redovisar data från cancerregistren och anpassa den till att redovisa kvalitetsindikatorer för screening • NORSCIR (Ryggmärgsskaderegistret)- status Norge, Danmark (Finland),(Sverige) • Prostatacancer: ett forum för samarbete Sverige, Norge, Danmark, Finland • Ryggregistretpilotstudie, uppföljning av Ryggkirurgi, jämföra behandlingsindikatorer mellan länder • Swedeheart: SCAAR: samma uppsättning variabler används i nordisk länder(Island skickar data) • Tonsilloperationsregistret: Sverige, Norge, Danmark • Urinblåsecancer: Norge, Danmark o Finland

  3. Aim with project- NORDIC COLLABORATIONS ON REGISTRIES The overall aim is to improve the conditions for: • international comparisons on treatments, patient outcome and care • international cooperation in rare diseases • knowledge sharing in research • quality enhancement • international development • patient involvement in quality • Being able to create conditions for comparisons within the Nordic countries • Supported by NORDFORSK and Office of the National Quality Registries in Sweden

  4. participants • Tina Lidén Mascher, Office of National Quality Registries, Sthl, SW • Gunilla Jacobsson Ekman, MMC/QRC Fou-enhet,Sthl,SW • Paul D. Bartels, The Danish Clinical Registries - a national quality improvement programme, Aarhus,DK • Michael Borre, Department of Clinical Medicine- Department of Urology Aarhus, DK • Halla Sigrún Arnardóttir, The National University Hospital, IC • Arto Vuori Institute for Health and Welfare (THL), FI • Unto Häkkinen Centre for Health and Social Economics (CHESS), FI • Eva Stensland, Norwegian Advisory Unit for Medical Quality RegistriesSKDE, NO

  5. Guidance Document/Report • Information on regulations, organization and practices for the individual countries • Similarities and differences • Checklists for collaborations • Suggestions for improvements

  6. Whycollaborations? • Differenceshavebeenreported • Improvecare • To increase population • Biggerdatasets • Morereliabledata

  7. WhyNordic collaborations? • An important resource for research and innovation, and many of the registers publish research findings • Several collaborative research projects among quality registries across the Nordic • Collaborate with industry to follow up effects • Nordics –an opportunity to take a leading position in the development of more efficient and equitable health care

  8. BACKGROUND: aging population, costs need for improving efficiency within EU • Patient mobility directives • Bo Könberg: "The future Nordic health cooperation," Nordic Council of Ministers, 2014 • “EU Methodological guidelines and recommendations for efficient and rationale governance of patient registries” • EU commission: From early developments to patient’s use of pharmaceutical products and medical devices”. • EMA: Pilots on collection and generation of real world clinical evidence, to measure safety and effectiveness • June 17th 2016 the Council of EU published conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. The council considers further investments, at national and EU level, in the availability of registries and in the developments of methods to assess the effectiveness of pharmaceuticals • Horizon 2020 & Innovative Medicines Initiative (IMI) promoting open access to research data while fully respecting applicable legislation on data protection

  9. Definitions, system, legal - Sweden • Definition Qualityregistries: • A Quality Registry contain data on individual patients within the healthcare system • Legal framework • National organization • The data responsibility for quality registries lies with the Regional and Local authorities (“CPUA”-central personuppgiftsansvarig)

  10. Definitions, system , legal- SWEDEN Vs. Norway and Denmark • Norway and Denmark • similar systems • definitions • Norway • main purpose is to improve quality in medical practice, used by clinicians in the hospitals throughout the country to improve quality nationwide. • Legally - systems are similar, not identical • Denmark • mandatory for hospitals, other health care institutions and practicing professionals to collect data on patients for the quality registries

  11. Definitions, system, legal-swedenvs. Finland and iceland Finland&Iceland: No official definition of quality registries. Patient registries, research databases which include data on an individual level Can be utilized in Nordic collaboration.

  12. Data protection Different Nordic implementation? • Denmark • Quality registries similar status to State-owned Registries - exempted from patient consent. • Requires approval of population definition, variables and indicators according to strict criteria by the Danish Health Data Authority every 3 years. • Remaining Nordic countries • requires patient consent to data collection in their quality registries

  13. Sweden • No ofregistries: 96 (+12) • Classificationofcertification: 4 levels(evaluated on predefinedcriterias) • Scope of quality registries tends to be defined mainly by disease area • Linked or merged data • Coverage 74% of registries (80%) • Data/statistics Used for quality of care, clinical improvement, research & innovation • Diagnosis, Treatments, Patient related data and outcomes etc. • Funding: state, regions, industry • Regions are responsible

  14. DENMARK • No ofregistries: 66 • Data on diagnostic procedures, treatments and outcomes • Common plattform • 50% in the variables of these registries are derived from the state national registries • 90% coverage (the health care providers duty) • Funding: state and region, Direct funding from industry, is presently strongly discouraged (but included in research projects). • Reappraisal in the national health authority every 3 years

  15. DENMARK • Mandatory public reporting of results • Business intelligence system figures distributed to management o individual clinical teams to facilitate quality management • Regions and municipalities are responsible • Responsibility for analyses, data management, reporting, budget, resources are centralised in one national supporting organisation. • Rely more heavily on the national state driven registries • Onlyvariablesrelatedto qualityofcareonly be collected and PRO • Notification of the ethical committee required if biobanks are involved, direct contact with patients • Registry-organisation (RKKP) legally approved research initiated in cooperation with private actors is however possible (and not unusual • Strong relationship with authorities

  16. NORWAY • No ofregistries: 54 • Consent must normally be obtained from patients. However, some national quality registries (Cancer Registry of Norway and Norwegian Cardiovascular disease registry) are non-consent-based heath registries. • Patient related measures should be included and patients should be represented in steering committees • Data processing subject to notification to data protection authority • Registries with personally identifiable characteristics without the consent -subject has the right to refuse the processing • The regional committee for medical and health research ethics may decide that personal health data can and shall be handed over by health personnel for use in research,

  17. finland • No qualityregistries (per definition) • Registriesfor qualityimprovement and research. Three legal bases for establishingQualityregistries: • Part of patient documents • Base on specificWrittenconsent • National registries • Hospital districts are investing heavily in new registries. • 10 national quality registries and dozens existing or planned-to-be regional quality registries. 20 national healthcare registries • For pure register based research no Ethical Review is required by law • National Insurance Institution (Kela), may require Ethical Review, before giving the official permission to access data.

  18. ICELAND • No procedures for national quality registries but health data is collected Two types of health registries in Iceland: • Registries on health data operated by the Directorate of Health (DOH). Do not require consent. • Landspitaliregistries (disease)operated as part of medical records or as a part of quality management • Registries are also used for cost management. • 90% or more of national healthcare datasets are being linked to health care data • Ministry of Welfare´s policy (welfare & health 2020)-increased use of databanks and biobanks, international collaboration with academia and industry • Data for scientific purpose needs approval from an EC (and DPA) • Transition is planned from health registry to quality registry in close collaboration with Landspitali • The University of Iceland to create a data portal for health related data sources (encrypting data) available through a single point of access, include hospital records, primary care records, data from social and health insurance, and registries.

  19. Similarities • System, culture, “language” • Purpose: Follow up quality of care, quality improvement and used for research • Subjects' identifiers • Linkage of data possible • Legal basis and framework • “Clinical ownership” • All work internationally and have Nordic networks • Data can be used for improvementwork, knowledge management, research and innovation • Different plattforms • Exchange data is possible

  20. Similarities & differences (1/2)

  21. Similarities & differences (2/2)

  22. Planning (1/2)

  23. Planning (2/2)

  24. conclusions • Nordic collaboration using quality/patient registries ispossible • Legal frameworks are currently not clear in all Nordic countries • Large benefits when plan and discuss: data, IT, legal, ethics • Nordic role models exist, e.g. Nordic arthroplasty register association (NARA) • Possiblilities to include Finland and Icelandevenmore

  25. Suggestions for improvement • New Data Protection Act:. Take actions for similar implementation during the coming 6 months. • For linkage of data by the authorities, a preset time limit should apply • To develop a Nordic research  infrastructure and platform • Solutions that enable and secure financing and unbiased registry work • National center for coordination of approvals etc. • One ethical approval using registries within the Nordic countries. • Enabling legal, organizational and IT-solutions to follow patients through admittance, transfer between different care givers, to discharge and long-time follow up • A forum for exchangeofexperience

  26. Tina Lidén Mascher kristina.lidenmascher@skl.se

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