The ATTRA project involves several clinical registries which have been maintained since 2002 under the surveillance of the Czech Rheumatological Society - the expert guarantor for this project. The ATTRA project is a multicentre system which has been designed to monitor the progress and results of biological therapy applied to inflammatory rheumatic diseases. A number of Czech rheumatology centres participate in the project. Institute of Biostatistics and Analyses Ltd, a spin-off company of the Masaryk University, provides management and other services to this project.
In 2012, the entire project was revised in order to be adjusted to actual needs. Demands on the quality of collected data have risen steadily, and greater emphasis is put on long-term follow-up of patients (even after the termination of biological therapy) as well as on the possibility to compare the results of biological therapy with a control group. These requirements have recently been formulated by the EULAR expert group, for example (Dixon et al., Ann Rheum Dis 2010; 69: 1596-1602) and are a natural consequence of the basic purpose of the registry, which is the follow-up and a comprehensive analysis of safety and real effectiveness of biological therapy.
The registration of clinical data is done orderly and systematically. The parametric assessment of treatment process not only allows to meet the research objectives, but also to develop treatment guidelines, to define entry criteria for treatment start, and to assess the treatment response correctly.
The continuous data assessment and feedback are provided to physicians and health care management, meeting the requirements of evidence-based medicine. Patients rights are fully respected and data collection is anonymous (de-identified), i.e. without personal data. An extensive programme of Quality of Life (QoL) monitoring is involved in the ATTRA project.
Adverse effects are classified using the MedDRA (Medical Dictionary for Regulatory Activities) terminology, which, besides other things, makes it possible to use data from the ATTRA registry in common analyses of European registries.