A registry is an organised system that uses observational methods to collect uniform data on specified outcomes in a population defined by a particular disease, condition or exposure. A register is the database deriving from the registry (such as the EU PAS Register), and the difference between the two terms should be clearly understood even if they are often used interchangeably. The terms ‘register’ or ‘registry’ are sometimes incorrectly used to designate an exhaustive list of all patients who meet the eligibility criteria of a study, regardless of their inclusion in the study. The term ‘patient log-list’ could be used for this purpose.
A patient registry should be considered as a structure for the standardised recording of data from routine clinical practice on individual patients identified by the diagnosis of a disease, the occurrence of a condition (e.g., pregnancy), the prescription of a medicinal product (e.g., monoclonal antibodies) , a hospital encounter, or any combination of these.
In European Nordic countries where there is a comprehensive registration of hospital data for a high proportion of the population, government-administered patient registries are administrative systems based on hospital encounters including visit information, diagnoses and procedures, such as the Norwegian Patient Registry, the Danish National Patient Registry or the Swedish National Patient Register. They may however lack information on lifestyle factors, patient-related outcomes and laboratory data. A review of 103 Swedish Healthcare Quality Registries (J Intern Med 2015; 277(1): 94–136) describes additional healthcare quality registries focusing on specific disorders initiated in Sweden mostly by physicians with data on aspects of disease management, self-reported quality of life, lifestyle, and general health status, providing an important source for research.
|10. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|