NORDIC COLLABORATIONS ON REGISTRIES SIMILARITIES & DIFFERENCES Tina Lidén Mascher, R.N., Degree in Physioth., MBA Strategist International projects and collaborations with the industry Health and Social Care Division Swedish Association of Local Authorities and Regions
EXAMPLE COLLABORATIONS IN THE NORDICS Cancer in Children: Nordics Lithuania Cancer in lever, gallbladder: Denmark, Norway, Sweden Cataract: Denmark, Sweden Hemophilia: Nordics Infectionous disease (HIV,Hepatitis): Iceland, Sweden Multiple Sclerosis: Sweden, Denmark NORDCAN (Cervixcancer): Nordics NORSCIR (Ryggmärgsskaderegistret)- Norway, Denmark (Finland),Sweden Prostate cancer: Sweden, Norway, Denmark, Finland Spine surgery: Nordics Cardiovascular registry: SCAAR: Nordics Tonsillectomy: Sweden, Norway, Denmark Cancer in Urine bladder: Norway, Denmark, Finland
AIM WITH PROJECT - NORDIC COLLABORATIONS ON REGISTRIES Overall aim - 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
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 Registries SKDE, NO
RESULT Guidance Document/Report includes Information on regulations, organization and practices for the individual countries Similarities and differences Checklists for collaborations Suggestions for improvements
WHY COLLABORATIONS? Differences have been reported Improve care The population is available To increase population More reliable data Bigger datasets
WHY? NORDIC COLLABORATIONS Registries - an important resource for research innovation, many of the registers publish research findings Several collaborative research projects among quality registries across the Nordic Collaborate with industry to follow up effects An opportunity to take a leading position in the development of more efficient and equitable health care
BACKGROUND: AGING POPULATION, COSTS NEED FOR IMPROVING EFFICIENCY WITHIN EU Patient mobility directives B 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 Horizon 2020 & Innovative Medicines Initiative (IMI) promoting open access to research data while fully respecting applicable legislation on data protection
DEFINITIONS, SYSTEM, LEGAL - SWEDEN Definition Quality registries: 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)
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
DEFINITIONS, SYSTEM, LEGAL -SWEDEN VS. 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.
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
SWEDEN No. of registries: 96 (+12) Classification of certification: 4 levels (evaluated on predefined criterias) Scope of quality registries tends to be defined mainly by disease area Linked or merged data Coverage 74% of registries (80%) Used for quality of care, clinical improvement, research & innovation Patient related measures should be included Diagnosis, Treatments, Patient related data and outcomes etc. Funding: state, regions, industry Regions are responsible
DENMARK No. of registries: 66 Data on diagnostic procedures, treatments and outcomes Common platform in future 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).
DENMARK 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. Only variables related to quality of care only 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
NORWAY No of registries: 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 health 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
FINLAND No quality registries (per definition) Registries for quality improvement and research. Three legal bases for establishing Quality registries: Part of patient documents Base on specific Written consent National registries Hospital districts are investing heavily in new registries. 10 National quality registries and dozens existing or plannedto-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.
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. Landspitali registries (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 plan 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.
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 improvement work, knowledge management, research and innovation Different plattforms in each country Exchange data is possible
SIMILARITIES & DIFFERENCES (1/2) SW DE NO FI IC National organisational structure present IT structure and data transfer Data Security Data quality monitoring & improvement National structure with regional nodes IT structure coordinated by national service contractors, many IT-platforms Adherence to EU legislation Registries are responsible and carry out the work. National/regional support provided Difference Only one supporting organisation Difference Owned by supporting organisation, converging towards one system Acts on processing of personal data (EU directive) Similarity Difference Three approved IT-platforms supported by the national authorities Difference No national organisation Difference No national coordination Difference No national organisation Difference No national coordination Similarity Similarity Similarity Difference Similarity Difference No national coordination Difference No national coordination
SIMILARITIES & DIFFERENCES (2/2) SW DE NO FI IC Inclusion procedures Exemption from patient consent: mandatory registries Oral consent: quality registries Written consent: research Exemption from patient consent: research, requires separate approval from data protection agency Exemption from patient consent: mandatory registries Written consent: quality registries, which includes research No consent needed for mandatory registries. Research and biobanking Registries can be used for research after application to the registry holder/responsible authority. Ethical approval is required. Biobanks are available, and are available for research after application to the responsible authority. Ethical approval is required. Difference Biobank coupling of data to registries requires ethical committee approval and patient consent Similarity Similarity Similarity
PLANNING (1/2) Definition of population Registry data content Project scope Required registry knowledge and/or registry analysis expertise Planned project - One country = one population - Several countries = one population - Guidelines on international, national and local levels - One project, predefined - Few projects, adaptive content - Collaborative projects, > 5 years - Tailored project - Project harmonizing with collaboration Present situation Are there established processes for data gathering, transfer and storage? Are there existing registries? Which data do they register? On which basis? Similarities? Differences? Similar ongoing projects running right now? Can we make use of previous experience? How much a) specialised knowledge on the registries b) expert knowledge on data management and statistics do we have? Possibilities -> Revised Planned project What design of process for data transfer and processing would work? Which "model" fits? Which "model" fits? What level of experience and expertise is needed? Necessary Actions Set up secure and stable routine for data transfer and data storage Make adaptations to make the model function in reality? Form necessary collaborations, establish formal agreements Gather and re-use previous material Recruit necessary resources (hourby-hour, contracting etc)
PLANNING (2/2) Planned project Present situation Possibilities -> Revised Planned project Necessary Actions Analytical scope (visualization, quality improvement or research) Descriptive presentation of data Analysis of aggregated data Analysis of personal data What level of maturity of analysis do we have? How much further do we need to reach, and what does that take? Write up application for ethical approval? Application to other authorities? Itemized project planning For example Register historical data Revise patient information Inform registry users Extract and quality check data Analysis Where is much work needed? What takes most time, and how long? What may need to be repeated/revised? What would a suitable version 1.0 for an itemized time scheduled project plan look like? Flow chart (incl. ethical approval and other applications) -> realistic time perspective and efficient project performance?
CONCLUSIONS Nordic collaboration using quality/patient registries is possible Legal frameworks are currently not clear in all Nordic countries Large benefits- plan and discuss: data, IT, legal, ethics Nordic role models exist, e.g. Nordic arthroplasty register association (NARA) Possibilities to include Finland and Iceland even more
SUGGESTIONS FOR IMPROVEMENT New Data Protection Act: Take actions for similar implementation When applying for linkage of data by the authorities, a preset time limit should apply To develop a Nordic research infrastructure and platform that enables researchers to use quality register data and link them with other registries Solutions that enable and secure financing and unbiased registry work should be supported by Nordforsk and the Nordic ministries Approvals by ethical and health authorities should preferably be coordinated by a National center. One ethical approval should be enough within the Nordic countries. Enabling legal, organizational and IT-solutions to follow patients through admittance, transfer between different care givers, to discharge and longtime follow up should be consider. This would result in complete follow up of patients in registries. A forum for exchange of experience
OTHER EXPERIENCES Research purpose Non prestige collaboration Standardized data Personal information: Coded so it cannot be traced to any individual Secure safe data handling (Sweden: CPUA) Shared platforms Agreements When applicable, Clear guidelines from authorities For Nordics: Professional secrecy
TACK! Tina Lidén Mascher kristina.lidenmascher@skl.se +46 8 452 71 75 www.kvalitetsregister.se