What Kind of Registry?

The planning phase is by far the most important phase for a register, where thorough work should be done. What kind of register do I want to establish, and what is the purpose of the register?

Good planning will significantly improve the quality of register data and increase the use of the data collected. It is therefore important to think carefully about whether the purpose of the register is only research, whether it is only quality assessement of clinical treatment, or whether it is a combination of these two purposes.

In connection with the collection of data for a project-specific research study, data will be temporarily stored in an approved IT solution (registry solution). Such a "registry" will be of limited duration and will be the source for answering specific research questions set out in a research protocol. A typical example of these types of studies/registries is health research studies.

The main rule of research is that there must be a consent from the included participants. After the project has analyzed and published the research results in line with the stated objectives of the protocol, the project is considered completed. Data will be anonymized or deleted at some point after the end of the project.

Data included in a quality registry is collected as part of a patient's course of treatment, where data is retrieved from the official patient management systems (e.g. in a journal). The data is used to analyze and measure the quality of patient care that is performed, and is an important indicator of quality in health care. The clinical record systems are poorly suited to create reports and perform statistical analyzes, therefore data is transferred to a separate register solution (database).

Data must be well structured so that it can be quantified more easily in a report or in a statistical analysis. Quality registers are often of very long duration and data collection takes place over many years. This is because the main purpose is to capture change in quality of treatment over time.

A long-term research registry, with so-called broad consent, is a registry that collects data for use in future research. If research studies are to be established, where data from a long-term research registry will be used, there must be an independent project-specific treatment basis. At OUS, this is achieved by reporting the study in the usual way through the electronic notification form. Other companies have their own routines. Studies that fall under the Health Research Act must also be approved by the Regional Committees for Medical and Health Research Ethics (REK).

The national service environment for medical quality registries in South-Eastern Norway Regional Health Authority (HSØ) offers assistance for the establishment and operation of medical quality registries originating from the region. Today there are over 50 national medical quality registries that collect data from all hospitals in Norway. There are special regulations and support related to these national registries. For more information, see www.kvalitetsregistre.no/.

At HSØ, responsibility for the national service environment has been delegated to the Department of Biobank and Registry Support, Research Support Services, Oslo University Hospital (OUS).

For application for data from the national registries, see helsedata.no.

Questions related to the operation of national medical quality registries in the Health South-East can be addressed to Fagsenter-kvalitetsregistre@OUS-hf.no.