The oncohematology registry is to be launched by September 30, 2022 – it is foreseen in the draft regulation of the Minister of Health. The registry will help optimize the diagnosis and treatment of patients with haematological malignancies. What data is collected therein?
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On July 8, the Ministry of Health submitted for consultation a draft regulation providing for the establishment of: From the Polish Onko-Hematological Register “PROH”† The registry should enable the collection of complete data that can be used in analyzes of the optimization of diagnostic methods and treatment of haematological cancers.
There are 21 days to submit comments. The Ministry of Health proposes that the provisions of the regulation enter into force 14 days after publication. The registry should be launched by September 30, 2022, which will allow the necessary preparatory work to be carried out.
There is a lack of complete data on neoplasms of the hematopoietic system in Poland
As we read in the justification of the regulation, the progress of knowledge in the diagnosis and treatment of hematologic neoplasms makes it necessary to evaluate the effectiveness of treatment methods at the population level, and due to the lack of adequate clinical data on neoplasms of the hematopoietic system , it is impossible to assess the extent of application of individual treatment methods.
The Ministry admits that the epidemiological data on neoplasms of the lymphatic and hematopoietic systems processed and collected by the National Cancer Registry is insufficient, therefore it is necessary to establish a special registry that can be used in analyzes of the optimization of methods for diagnosis and treatment of hematologic neoplasms.
The registry makes it possible to determine epidemiological indicators, including the number of cases, morbidity, number of recoveries, speed of implementation of diagnostics and treatment and their effectiveness. The data collected in the registry will also enable the assessment of risk factors such as regional differentiation of incidence, mortality and survival, and will enable the development of treatment standards and their evaluation, as well as the identification of the number of patients receiving modern therapies. .
In particular, it is believed that the implementation of the registry will ensure:
- creating a unified system for the registration of new cases of cancer of the lymphoid and hematopoietic tissue (according to the International Statistical Classification of Diseases and Medical Problems ICD-10: C81-C96, D45-D47);
- preparation of the basis for population epidemiological studies that allow reliable analyzes of the frequency and trends of the above cancers in real time;
- assessment of the frequency of individual neoplasms of the lymphoid tissue, blood system and related tissues;
- monitoring the health of recipients of services related to diseases of the lymphatic, circulatory and related tissues, depending on the therapy used;
- monitoring the effectiveness and quality of the treatment of oncohaematological diseases, depending on the therapy used and the patient’s condition, the stage of the tumor and the treatment used;
- registration of long-term results and treatment consequences depending on the applied therapy;
- systematic publication of reports based on data collected in the register.
What data is collected in the hemato-oncology registry?
The entity maintaining the registry is Narodowy Instytut Onkologii im. Maria Skłodowskiej-Curie – National Research Institute in Warsaw.
The register is maintained using an ICT system that ensures interoperability and links with other ICT systems in healthcare. It will process data and identification data, including:
1) personal data about the recipient:
- first name(s) and surname,
- PESEL number, and in the case of people who do not have a PESEL number – a series and number of a passport or other identity document, or a unique identifier given by a Member State of the European Union for cross-border identification,
- date of birth,
- address of the place of residence,
- identification numbers and registration numbers assigned to recipients by payers or service providers,
- date of death or the date the body was found,
- cause of death (primary, direct, secondary);
2) individual medical data of the recipient:
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a) assessment of the patient’s condition and tumor stage according to:
- ECOG (Eastern Cooperative Oncology Group) scale (0-normal fitness, 1 presence of disease symptoms, 2 ability to perform personal activities, 3-limited ability to perform personal activities, 4 need to care for another person to care, spends all day in bed, 5 dead),
- Charslon comorbidity index (low risk, medium risk, high risk)
- stage of tumor development according to the Ann Arbor classification (I, II, III, IV, extension A, B, E, X, Bulky),
- R-ISS (Revised International Staging System for Multiple Myeloma (I, II, III), Rai (0, I, II, III, IV, V) / Binet (A, B, C)),
- FLIPI / FLIPI2, IPI / R-IPI, MIPI,
b) date, type and result of the diagnostic tests performed:
- cytogenetic test,
- immunohistochemical examination,
- molecular research,
- flow cytometry,
c) diagnosis of primary neoplasm, recurrence or transformation:
- date of diagnosis of the primary tumor,
- date of relapse,
- transformation date and transformation morphology,
- Main reason code according to “ICD-10”,
- description and location of the tumor,
- date of the morphological result (date of collection of the material or date of receipt of the material by the pathology laboratory, or date of approval of the result),
- morphological type – description,
- morphological code according to “ICD-O”,
- additional features during diagnosis (splenomegaly, hepatomegaly; involvement of nodes above the diaphragm, involvement of nodes below the diaphragm, involvement of marrow, involvement of other organs),
d) date and type of treatment in the field of medicinal products:
- start date of the treatment line,
- treatment line,
- type of treatment (remission induction, remission consolidation, maintenance therapy),
- name of the medicine,
- name of the treatment regimen,
- response to treatment (CR – complete, PR – partial response, RD – tumor remission, PD – tumor progression, SD – tumor stabilization),
- treatment end date,
- reason for treatment discontinuation (lack of efficacy, toxicity, patient decision, drug unavailability, end of planned therapy, patient death),
- place of death (hospital, other healthcare facility, home, etc.),
- information about the medicines used:
– contract product code according to the product catalog specified by the National Health Fund,
– unit product code according to the product catalog specified by the National Health Fund
– application date,
e) procedures performed according to “ICD-9”,
f) the start date of the care,
g) date of termination of care;
3) identification number of the service provider,
4) identification number of the place where the healthcare is provided,
5) ID of the medical worker who:
a) entered data in the register,
b) provided the care
Haematological registers have proven themselves in other countries in Europe
As we can read in the explanatory notes to the project, in other countries (e.g. Denmark, Czech Republic, Sweden, Finland, Ireland and Australia) there are oncohaematological registers that are a source of information and allow to assess the effectiveness of treatment in this group. diseases. The 5-year survival rates of patients with haematological cancers indicate significant differences in the effectiveness of the treatment of these diseases in Poland compared to other EU Member States. As shown by the survival analysis in the Concord-3 project, the difference in patient survival in Poland compared to other Member States is 20-30 percentage points. In the case of lymphocytic leukemia, the survival rate in the Member States of the European Union is about 70%, while in Poland – 52%; in myeloid leukemia this will be approximately 57 percent respectively. and 27 percent
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