Creation of the population-based cancer registry in Ukraine and
its information technology developement began
in 1989 at the National Cancer Institute of Ukraine. This was initiated and performed with
the efforts of the Department of Scientific Fundamentals of Cancer Control.
The aim was to create a reliable information basis for population-based onco-epidemiological studies
(burden of cancer, its dynamics and features,
assessment of anti-cancer measures taken and their effect)
as well as for clinical needs.
The organizational fundamentals for the National Cancer Registry (NCRU) were
(1) the oncological service system, which exists in Ukraine since the 1950s and consists of the oncological health care institutions in each oblast, and
(2) the state cancer registration system with its well-established ways of informing through paper notifications on each diagnosed and/or treated cancer case (is currently regulated by the Orders of Ministry of Health of Ukraine No 845 of 01.10.2013, No 1 of 10.01.2006 and No 629 of 10.10.2007), as well as obtaining of data on deaths of cancer patients in the local bodies of state registration of civil status.
The database of the NCRU is distributed by regions and contains information about all Ukrainian citizens with cancer. In some oblasts (Vinnytska, Zhytomyrska, Luhanska, etc.) the unified information technology of NCRU has been implemented in the early 1990s, but in most ones the automated registration of the personalized information about cancer patients was introduced during 1996-2000 after the approval of the Order of Ministry of Health of Ukraine No 10 of 22.01.1996 "On the establishment of the national cancer registry of Ukraine". At the beginning, the source for the electronic database of NCRU were the accumulated in regional oncological health care institutions paper files that contained information about each cancer patient who was registered and alive at the year of NCRU information technology implementation, including those diagnosed in 1930-1990. In most oblasts, in the year of oblast population-based cancer registry start-up, information on all cancer patients who died in that year was also entered into the electronic database.
The starting date of registration of complete cancer incidence and mortality in each oblast is different; since 2000, the unified information technology for cancer registration has covered all oblasts of Ukraine, but complete data on cancer mortality in whole Ukraine are available in NCRU since 2002. Until 2014, the NCRU database had annually increased by 150-160 thousand of new cancer cases. After 2014 the NCRU does not receive data from the Autonomous Republic of Crimea, and Donetska and Luhanska oblasts are covered by the NCRU unified information technology only partially, that is why the annual number of new cancer cases in this period was about 140 thousand. At the beginning of 2021, the NCRU database contained more than 4 million records on cancer patients, of which more than 1 million were registered as living ( http://www.ncru.inf.ua/publications/ucr_db_today.pdf).
The consolidated database of NCRU consists of the databases of oblast cancer registries that operate in the regional oncological health care institutions. Each oblast cancer registry aggregates information about all cancer patients who permanently residing in the oblast. The information technology of NCRU facilitates regional cancer registries to generate on-line (prompt) information for annual state statistical reports immediately after the end of the reporting year and to serve many information requests from local authorities and other users.
Once a year, the central unit of NCRU, which is located in the Department of the National Cancer Institute of Ukraine, merges oblasts databases into a general database of the whole Ukraine for calculating statistics and creating information and analytical materials on cancer epidemiology for publication in the annual Bulletin of the NCRU "Cancer in Ukraine: incidence, mortality, prevalence and other relevant statistics", conducting onco-epidemiological research and publishing its results in the scientific journals. The central unit of NCRU also generates sample databases for participation in the international studies and projects, answers the information requests, etc.
The Bulletins of NCRU contain the most correct statistics that depict cancer burden in Ukraine. To ensure greater completeness and reliability of the published data, the NCRU calculates the adjusted rates of cancer incidence and mortality not earlier than one calendar year after the end of the reporting year (or after the last year of observation for the long-term population study). As a result, the adjusted rates change by 5-15% compared to their operational (prompt) reporting values received by the Center for Medical Statistics of the Ministry of Health from oblast cancer registries at the beginning of the next after reporting year. We show on-line (prompt) data of the last year in the relevant part of each nosologic section of the Bulletin, but one should consider them only as rough provisional information that will be amended. If there is no extreme outbreak in the process, the adjusted cancer incidence and mortality rates of the year before last describe current cancer burden in Ukraine and oblasts most objectively. In the current period of the reformation of health services, the adjustment period for cancer registration very likely should be extended as a consequence of the worsen discipline of sending notifications about the diagnosed and/or treated cancer cases to the oblast cancer registries and the complicated access of their employees to the data on patients' deaths. In the international practice, the adjustment period for cancer data lasts at least 2 years.
The NCRU is a member of the European Network of Cancer Registries (ENCR). The NCRU database (its anonymized records) is used in such WHO publications as "Cancer Incidence in Five Continents" ( Vol. X and Vol. XI), "International Incidence of Childhood Cancer", Vol. III, which indicates compliance with the modern international requirements for the registration of cancer information, as well as in a number of international projects, such as the European Cancer Information System, Global Cancer Observatory, Global Cancer Facts & Figures, Global Burden of Disease Study and others.
The principle of organization of the NCRU database is aggregation (consolidation) of information about the oncological diagnoses of the patient, all episodes of his treatment and observation into a single electronic registration card. The content of this card is determined by the form No 030-6/o "Registration card of a patient with cancer" (see example and general data structure).
More detailed information about patients - information about episodes of hospitalization and inpatient anti-cancer treatment - is contained in the hospital cancer registries (HCRs), which accumulate respective databases in the oncological health care institutions. Currently, the unified information technology of HCR, which is developed with similar to the NCRU information model, is functioning in 28 specialized medical institutions, including the largest oncology clinics of Ukraine - the National Cancer Institute, Kyiv city oncological center, Vinnytsia, Kharkiv, Lviv oblast oncological centers and other oblast, city or rayon oncological dispensaries.
HCRs collect detailed information on the special treatment provided, in particular
· chemotherapeutic (drug in terms of the international non-proprietary name, method of administration, total dose)
· radiation (its type, location and dose of radiation),
· surgical treatment protocols (names of interventions and operated organs/sites, type of anaesthesia, blood loss, surgeons, etc.), as well as
· information about the patient's vital and health status (concomitant pathologies, complications, metastases, recurrence of the disease, etc.).
About 80% of cancer patients in Ukraine receive medical care in inpatient departments of the oncological health care institutions at the place of their residence, and so, most of them are registered in the database of the relevant HCR.
The data structure and software of the NCRU and HCR systems are harmonized in terms of a common information model. Due to this, the technology of the automated data exchange between the hospital and the population-based registry was created, based on the formation of the electronic report form ("electronic hospital abstract report") that contains information in accordance with the form No 027-1/o. Appropriate electronic hospital abstracts are automatically generated by the HCR system for each patient with a malignant or in situ neoplasm who has been treated in the hospital. These files are subject to transfer to the regional population-based cancer registry. Processing of the electronic hospital abstracts avoids multiple registrations of the same data and minimize errors that may occur when entering data from the paper docs, it facilitates search operations and identification of the registered patients and it is one of the tools to ensure registration completeness.
Developed in the NCRU programs and means of data linkage, together with the experience of the automated processing of data from various sources allow to conduct research that is extremely time-consuming when using traditional technologies. For example, in cooperation with the Scientific Center for Radiation Medicine, a search is being conducted for cases of malignant neoplasms among the liquidators of the Chernobyl accident. Joint research with the Institute of Endocrinology and Metabolism is underway. In cooperation with the Institute of Occupational Medicine, attempts were made to compare large arrays of data about the exposed to the occupational risks persons with the NCRU database to determine the degree of risk of cancer in this population. Technology for the automated search of cancer patients' deaths in a regional death registry was worked-up, which allowed detection about 10% of deaths, which were not found by manual extracting (we detected the cases of death mainly from causes, which were not related to cancer). The role and capability of such tool in the processing of medical information grow steadily with the implementation of new electronic databases in the field of health care in Ukraine.
Since the establishment of the NCRU and HCR systems, we implemented standards and rules of registration of cancer according to the International Classification of Diseases for Oncology (ICD-O) ( the 2nd revision of the 3rd edition of the ICD-O will be implemented in the NCRU in 2022), definition of stage of the disease according to the TNM classification, rules for registration of multiple cancers, checks of compliance and quality of data, etc. NCRU and HCR provide registration of tumour of any site and any morphological type according to the ICD-O specifications as well as automated definition of the appropriate ICD-O topography and morphology codes; coding of children's neoplasms according to the ICCC classification is also provided.
The NCRU and HCR software provide identification of each patient and have advanced functions of the assistance to registrar that help to avoid many errors and contradictions in the registered data, duplication of records about patients and their diagnoses. The level of duplicate patient registration was reduced to rare accidents, while 10-15% of repeatedly registered persons were found in paper files during the automation.
The unified automated procedures have reduced subjectivity in such important characteristics of a tumor diagnosis as ICD code (which is determined automatically based on the site and the morphological type of the tumour) and stage (determined automatically based on the registered tumour parameters of TNM classification). The transition from ICD-9 to ICD-10 codes in 1998 was automated for all databases of NCRU and HCRs using the procedure of the automated determining the appropriate ICD-10 code based on the morphological type, site and behaviour of each tumour registered. The same unified approach provides the updating of ICD-O classification, as well as will provide the automated transition to the Australian modification of ICD-10 classification ( ICD-10 AM ) starting from 2022. The automated technologies and advanced automated data check procedures significantly increase the reliability of oncological information.
The calculation of annual state statistical reports as well as various additional report forms and rates is performed by the regional cancer registries automatically using the unified software on their database. The unified approach eliminates regional differences in the interpretation of typical situations and allows justifying and, if necessary, objectifying the obtained rate with conducting direct review of data of each patient, who was taken into account when calculating this indicator.
The central unit of NCRU provides information and methodological assistance to all regional cancer registries and HCRs, support and improvement of the software and codifiers, control of completeness and quality of the registered data and conducts epidemiological researches at the national level. Software tools that support standardization and data quality in the NCRU are regularly updated. Developed in the central unit of NCRU information technologies of NCRU and HCR are unique and there are no similar systems in Ukraine yet.
The completeness and timeliness of obtaining data about cancer patients can be significantly improved with the connection to the electronic health care system (eHealth), provided that it will have all the specific parameters for cancer registration. The Concept of eHealth Development declared «gradual integration of eHealth with the existing national and branch registries», in particular with the NCRU, but so far there were no constructive contacts between the NCRU and the eHealth.
Our many years of experience show that the extent and nature of discrepancies between reports which were obtained on-line (promptly) and/or as a result of paper docs processing, compared with those obtained on the NCRU data (it was especially evident in the first years of introduction of the information technology), call into question the practical value and the effectiveness of the statistical information, which is NOT based on modern principles of collection and control of compliance with the rules of registration , processing of personal data and reporting in the field of oncology. It is equally important to realize that even after the abolition of notification paper forms and transition to solely electronic registration systems, doctor still has a duty to provide proper and complete data within the prescribed time; and without keeping these rules there is no reliable medical registry in any country.
NCRU's data structure (in Ukrainian)