Vnitr Lek 2014, 60(10):837-845

The user's reporting from the national registry of catheter aortic valve implantations (Czech TAVI Registry): the possibilities of the analytical reports based on the database system TrialDB2

Milan Blaha¹, Petr Kala^2,*, Daniel Klimeš¹, Ivo Bernat³, Marian Branny⁴, Pavel Červinka⁵, Jan Horák⁶, Viktor Kočka⁷, Martin Mates⁸, Petr Němec⁹, Ladislav Pešl¹⁰, Roman Štípal¹¹, Josef Šťásek¹², Michael Želízko¹³

¹ Institut biostatistiky a analýz LF MU, Brno, ředitel doc. RNDr. Ladislav Dušek Ph.D.

² Interní kardiologická klinika LF MU a FN Brno, pracoviště Bohunice, přednosta prof. MUDr. Jindřich Špinar, CSc., FESC

³ Kardiologické oddělení FN Plzeň, přednosta prof. MUDr. Richard Rokyta, Ph.D.

⁴ Komplexní kardiovaskulární centrum Nemocnice Třinec-Podlesí, přednosta prof. MUDr. Marian Branny

⁵ Kardiocentrum Masarykovy nemocnice Ústí n. Labem, přednosta prof. MUDr. Pavel Červinka, Ph.D.

⁶ II. interní klinika - klinika kardiologie a angiologie 1. LF UK a VFN Praha, přednosta prof. MUDr. Aleš Linhart, DrSc., FESC, FCMA

⁷ III. interní - kardiologická klinika 3. LF UK a FN Královské Vinohrady, Praha, přednosta prof. MUDr. Petr Widimský, DrSc., FESC, FACC

⁸ Nemocnice na Homolce Praha, ředitel MUDr. Milan Šetlík

⁹ Centrum kardiovaskulární a transplantační chirurgie, Brno, ředitel doc. MUDr. Petr Němec, a Mezinárodní centrum klinického výzkumu ICRC FN u sv. Anny, Brno, ředitel Gorazd B. Stokin, M.D., MSc., Ph.D.

¹⁰ Kardiologické oddělení Nemocnice České Budějovice, primář MUDr. František Toušek, FESC

¹¹ I. interní kardiologická klinika LF UP a FN Olomouc, přednosta prof. MUDr. Miloš Táborský, CSc., MBA, FESC

¹² I. interní kardiologická klinika LF UK a FN Hradec Králové, přednosta doc. MUDr. Josef Šťásek, Ph.D.

¹³ Oddělení intervenční kardiologie, Klinika kardiologie, Institut klinické a experimentální medicíny, Praha, přednosta prof. MUDr. Josef Kautzner, CSc., FESC

Assessment of the treatment procedures and their results is increasingly important in current medicine. The emphasis is put on an effective use of the health technologies (HTA). Unlike randomised studies, which involve strictly selected groups of patients who meet inclusion and exclusion criterias, the multicentre clinical registries provide a real-life picture of the treatment safety and effectiveness. Well prepared registries involve both research database and a friendly user interface enabling collection of parametric and easily analyzable data. Although there are some technological aspects aiming to ensure a maximum quality of entered data, cooperation with the users and data managers is essential. Such a registry, otherwise meaningful, must provide answers to previously defined medical hypotheses. Regular feedback to users (so called benchmarking or reporting) is considered to be of key importance. The Czech TAVI Registry (CTR) is a good example of reaching all of the above defined criterias. This registry contains data of approximately 95 % of all transcatheter aortic valve implantations (TAVI) performed in the Czech Republic. It is based on a general system aimed at the design of clinical trials, namely the TrialDB2 (a database system for clinical registries developed by the Institute of Biostatistics and Analyses at the Masaryk University (IBA MU). CTR has been run as an English-language version under the auspices of the Czech Society of Cardiology and represents one of the top-quality registries maintained by IBA MU. This paper presents the currently available database systems and some reports from this particular registry.

Keywords: clinical registries TrialDB; Czech TAVI Registry; parametric data collection; reporting

Received: March 7, 2014; Accepted: June 13, 2014; Published: October 1, 2014  Show citation