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 RegistriesSKDE, 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

PROJECT REPORT

https://www.nordforsk.org/en/programmes-and-

projects/projects/project.2017-11-

06.6533047689?set_language=en

https://www.nordforsk.org/en/programmes-and-projects/projects/project.2017-11-06.6533047689?set_language=en

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

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.

SWEDEN

No. of registries: 96 (+12)

Classification of certification: 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%)

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).

Business intelligence system figures distributed to management o individual clinical teams to facilitate quality management

Responsibility for analyses, data management, reporting, budget, resources are centralised in one national supporting organisation

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 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.

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

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

Biobanks

Data security

DIFFERENCES

National organisation

IT structure

Data quality, monitoring, control

Consent procdures

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 long-

time follow up should be consider. This would result in complete follow up

of patients in registries.

A forum for exchange of experience