How and How the Czech National Hemophilia Program Benefits Professionals and Patients
The Czech National Hemophilia Program (ČNHP) has been an interdisciplinary initiative for many years, coordinating specialized care for both pediatric and adult patients with hemophilia and other congenital bleeding disorders in the Czech Republic. It was established on the platform of collaboration among experts from hematology centers that deal with this issue and is guided by the ČNHP Declaration, which is published on the association's website (see www.cnhp.cz).
National and International Collaboration
ČNHP is supported by professional societies ČLS JEP (Czech Hematological Society, Czech Society for Thrombosis and Hemostasis, Czech Pediatric Society) and also collaborates with many patient organizations (such as the Czech Hemophilia Association or Hemojunior), as well as regulators, payers, and healthcare providers (VZP, SÚKL, NRC). It is also active at the international level (collaborating with the World Hemophilia Federation /WFH/ registry, the European System for Safety and Surveillance in Hemophilia /EUHASS registry/, the prestigious European network of pediatric hemophilia centers PedNet, the patient organization – European Hemophilia Consortium /EHC/, McMaster University in Hamilton, Canada /WAPPS Hemo project/ and more).
The primary goals of ČNHP are the continuous improvement of diagnosis and treatment of patients with hemophilia, prevention, and timely initiation of appropriate treatment, improving the quality of life of patients, enhancing prenatal diagnosis, and advisory services for patients with hemophilia and other congenital bleeding disorders, increasing awareness about these disorders, rationalizing costs associated with the treatment and care of these patients, coordinating all processes associated with treatment, and centralizing care.
Main Tasks of ČNHP: Registry Management, Education, Recommendations
One of the tasks of ČNHP is also the management of a clinical registry. This registry, which has been running since 2011 and is also involved in the European Reference Network (ERN) in the field of hematology, collects highly valued comprehensive data from real clinical practice from patients with a specific disease. This allows continuous monitoring of the epidemiological situation in the Czech Republic (18 centers are involved in the registry) with the possibility of evaluating patient care in real-time.
Clinical registries are generally considered continuous projects, and the most challenging task is to ensure their long-term sustainable functioning. For patients, a registry should represent a tool to improve their chances in the fight against their disease. Thanks to this registry, a network of hemophilia centers across the republic has been created and stabilized. These centers include academic and medical workplaces, thus improving the transfer of experiences, new treatment findings, and current research news.
ČNHP focuses on educating doctors, scientists, university students, patients, their relatives, and the general public. Various educational materials are used for this, as well as organizing seminars and congresses for the transfer of knowledge and news from the field and real practice. These professional lectures aim to unify the functioning rules of the centers, unify diagnostic procedures, procedures for patient rehabilitation, and compare the epidemiological situation across the Czech Republic and compare it with the epidemiological situation in Europe.
Recommendations have also been formulated into professional guidelines for patient care and supported by professional societies. Of course, they are also regularly updated. ČNHP also ensures, in collaboration with professional societies, audits of hemophilia centers and monitoring the quality of entered data.
Collection and Analysis of Clinical Data
The technical support of the registry, organizational matters, analyses, and regular outputs for ČNHP are provided by IBA, s. r. o. (outputs are regularly published on the website: https://www.cnhp.cz/index.php?pg=registr--vysledky
The establishment of IBA, s. r. o (Institute of Biostatistics and Analyses, s. r. o.) dates back to 2014. It is a spin-off of Masaryk University with the parent institution's ownership stake. The company's activities are directed towards the pharmaceutical industry sector, the life science area, and RWE (real world evidence) data. For the collection of clinical data, the institute develops and operates its information systems (CLADE-IS).
Currently, the company offers a complete service including study or registry design, CRF/eCRF form design, preparation of materials and communication with regulatory bodies, ensuring professional guarantee from professional societies, reporting, study monitoring, and last but not least, clinical data analysis including advanced biostatistics. It also offers complementary services such as pharmacovigilance, graphic design, or market access.
Great emphasis is placed on security in the provision of IT services. The company meets the requirements of the ISO/IEC 27001 standard to ensure data confidentiality, availability, and integrity. It also has an established ISO/IEC 9001 standard for quality management.
doc. MUDr. Jan Blatný, Ph.D.
Department of Pediatric Hematology and Biochemistry, FN Brno
Bc. Nikola Štourač
Institute of Biostatistics and Analyses, s. r. o., Brno
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