[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]. / Uzivatelské výstupy z národního registru katetrových implantací aortální chlopne (Czech TAVI Registry): moznosti analytických výstupu zalozených na databázovém systému TrialDB2.

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.

DIOS - database of formalized chemotherapeutic regimens.

Chemotherapeutic regimens (CHR) and their administration are routine practice in contemporary oncology. The development of a structured, electronic database of standard CHR can help the faster propagation of information about new CHR and at the same time enable assessment of their adherence in clinical practice. The goal was to develop a standardized way to describe a regimen using XML, fill the database with currently available regimens and develop tools to assess the adherence of the treatment to chosen regimen, compare the dose-intensity and recognize the regimen from existing data on drug administration. The data are being inserted in cooperation with expert oncologists and the database currently contains about 260 CHRs. Such system can be used to enhance decision support systems and interoperability of HIS. The database and tools are available online on the internet.

Sharing datasets of the COVID-19 epidemic in the Czech Republic.

At the time of the COVID-19 pandemic, providing access to data (properly optimised regarding personal data protection) plays a crucial role in providing the general public and media with up-to-date information. Open datasets also represent one of the means for evaluation of the pandemic on a global level. The primary aim of this paper is to describe the methodological and technical framework for publishing datasets describing characteristics related to the COVID-19 epidemic in the Czech Republic (epidemiology, hospital-based care, vaccination), including the use of these datasets in practice. Practical aspects and experience with data sharing are discussed. As a reaction to the epidemic situation, a new portal COVID-19: Current Situation in the Czech Republic (https://onemocneni-aktualne.mzcr.cz/covid-19) was developed and launched in March 2020 to provide a fully-fledged and trustworthy source of information for the public and media. The portal also contains a section for the publication of (i) public open datasets available for download in CSV and JSON formats and (ii) authorised-access-only section where the authorised persons can (through an online generated token) safely visualise or download regional datasets with aggregated data at the level of the individual municipalities and regions. The data are also provided to the local open data catalogue (covering only open data on healthcare, provided by the Ministry of Health) and to the National Catalogue of Open Data (covering all open data sets, provided by various authorities/publishers, and harversting all data from local catalogues). The datasets have been published in various authentication regimes and widely used by general public, scientists, public authorities and decision-makers. The total number of API calls since its launch in March 2020 to 15 December 2020 exceeded 13 million. The datasets have been adopted as an official and guaranteed source for outputs of third parties, including public authorities, non-governmental organisations, scientists and online news portals. Datasets currently published as open data meet the 3-star open data requirements, which makes them machine-readable and facilitates their further usage without restrictions. This is essential for making the data more easily understandable and usable for data consumers. In conjunction with the strategy of the MH in the field of data opening, additional datasets meeting the already implemented standards will be also released, both on COVID-19 related and unrelated topics.

Breast cancer screening in the Czech Republic: time trends in performance indicators during the first seven years of the organised programme.

BACKGROUND: The Czech Breast Cancer Screening Programme (CBCSP) was initiated in September 2002 by establishing a network of accredited centres. The aim of this article is to describe progress in the programme quality over time after the inception of the organised programme. METHODS: The CBCSP is monitored using an information system consisting of three principal components: 1) the national cancer registry, 2) a screening registry collecting data on all screening examinations, further assessments and final diagnoses at accredited programme centres, and 3) administrative databases of healthcare payers. Key performance indicators from the European Guidelines have been adopted for continuous monitoring. RESULTS: Breast cancer incidence in the Czech Republic has steadily been increasing, however with a growing proportion of less advanced stages. The mortality rate has recently stabilised. The screening registry includes 2,083,285 records on screening episodes between 2002 and 2008. In 2007-2008, 51% of eligible women aged 45-69 were screened. In 2008, the detection rates were 6.1 and 3.7 per 1,000 women in initial and subsequent screening respectively. Corresponding recall rates are 3.9% and 2.2%, however, it is necessary to pay attention to further assessment performed during the screening visits. Benign to malignant open biopsy ratio was 0.1. Of invasive cases detected in screening, 35.6% was less than 10 mm in diameter. Values of early performance indicators, as measured by both crude and standardized estimates, are generally improving and fulfil desirable targets set by European Guidelines. CONCLUSIONS: Mammography screening in the Czech Republic underwent successful transformation from opportunistic prevention to an organised programme. Values of early indicators confirm continuous improvement in different aspects of process quality. Further stimulation of participation through invitation system is necessary to exploit the full potential of screening mammography at the population level.

Performance indicators in a newly established organized cervical screening programme: registry-based analysis in the Czech Republic.

In 2008, the organized Czech National Cervical Cancer Screening Programme (CNCCSP) was initiated by transformation of the existing opportunistic efforts. The aim of our study was to examine recent cervical cancer burden trends and to assess the quality of the Czech National Cervical Cancer Screening Programme using a set of standard performance indicators. Our study utilized data from the national Cervical Cancer Screening Registry and the Czech National Cancer Registry. We computed internationally accepted indicators and assessed time trends and variability among screening centres. Between 1995 and 2011, the incidence of age-standardized cervical cancer decreased by 21% (1023 cases in 2011), and the mortality decreased by 35% (399 deaths in 2011). The annual coverage of the target population by cervical screening increased to 56% in 2013 (as compared with 35% in 2001). If we consider a 2-year interval (2012-2013), the estimated coverage was 77%. Over two million women underwent screening in 2013; 96% of them had a negative result. About 0.2% of smears showed cytological signs of a high-grade intraepithelial lesion or a malignancy, and the estimated positive predictive value for advanced intraepithelial neoplasia (cervical intraepithelial neoplasia grade 2+) was 79.6%. However, performance indicators show considerable heterogeneity between screening centres. The reported values of performance indicators are in line with the results of programmes that have previously been shown to be successful in terms of decreasing the cervical cancer burden, and are promising with respect to an even more pronounced decrease in cervical cancer mortality in the near future, provided that continuous quality improvement can be maintained. Linkage studies between screening, cancer and cause-of-death registers can provide further information on screening effectiveness and validity issues.

Characterization of the DMD/BMD patient population in Czech Republic and Slovakia using an innovative registry approach.

Effective planning of clinical trials requires an appropriate number of patients who fulfil given inclusion criteria. In the case of so called "orphan" diseases, such as Duchenne and Becker muscular dystrophy (DMD/BMD), the number of suitable patients within one country is usually limited. We developed a detailed registry of Czech and Slovak DMD/BMD patients which may contribute to cooperation on the European level. The registry uses internet and database technologies with a multilevel architecture. Patients may view their own data. As of May 2008, 163 patients have been registered in the database. The registry provides a detailed phenotypic and genotypic description of patients. The main purpose of such a registry is the time-effective recruitment of eligible patients for a clinical trial or therapy and may allow the anticipation of possible future effects of appropriate therapy on individual patients. The importance of the DMD/BMD patient registries has recently also been rising with new clinical trials focused on mutation-specific approaches. Other outputs include assessment of epidemiology, phenotype and genotype relationships, or standards of care.