Breast Cancer Research and Treatment

Fadeeva E.V., Lanovaya A.M.

Results of foreign studies indicate a relatively high prevalence of smoking and alcohol consumption among healthcare workers, which can be explained by various socio-demographic and psycho-emotional characteristics, as well as stressinducing and psychological trauma factors related to their professional duties.Aim. Analyse predictors of smoking and alcohol abuse among health care workers.Materials and methods. The ASSIST screening test was used to assess the severity of clinically significant symptoms of substance abuse. The IES-R and K-10 questionnaires were used to evaluate psycho-emotional states.Results. It was found that among men working in the “obstetrics and gynecology” specialty, a significant predictor of smoking was a high level of distress (p ≤ 0.05), and alcohol abuse was associated with the absence of a marital relationship (p ≤ 0.01). For women, alcohol abuse was related to increasing age (p ≤ 0.001), high income (p ≤ 0.01), living in a large urban area (p ≤ 0.05), and being married (p ≤ 0.01). Among men working in the “psychiatry and addiction medicine” specialty, alcohol abuse was associated with high income (p ≤ 0.01) and education levels (p ≤ 0.05). For women, there were associations between alcohol abuse and young age (p ≤ 0.01), high income (p ≤ 0.001) and education levels (p ≤ 0.01), distress (p ≤ 0.001), and post-traumatic stress disorder symptoms (p ≤ 0.05). For women, regardless of specialty, smoking and alcohol consumption were positively correlated (p ≤ 0.001).Conclusion. The identified predictors of addictive behavior could become targets for targeted psychological and medical interventions.

Zheleznyakova I.A.

The potential benefits of supportive care offer patients more than many “palliative” methods of anti-tumor treatment. It should be regarded as a necessary part of comprehensive disease therapy rather than just an additional service. However, the imperfection of regulatory and organizational issues, including financial support, limits patients’ access to supportive therapy.Aim. To analyze regulatory legal documents governing the organization and financial provision of supportive therapy for oncological diseases and identify areas for optimization.Materials and methods. Content analysis and comparative legal analysis. The content analysis method was applied to 26 directly regulating various organizational aspects of medical care, including oncological diseases from 2012 to the present. In regulatory legal acts, the issues of organization and financing of supportive therapy for oncological diseases were specifically analyzed in terms of how well this area of medical care is regulated.Results. The current fundamental regulatory legal acts governing the organization and financial provision of supportive therapy for oncological diseases and controlling the quality of the provided medical care contain almost no clear provisions that specify practical issues related to supportive therapy.Conclusion. The absence of an officially established definition of “supportive therapy” within the Russian healthcare system and the lack of clear distinctions between the terms “medical rehabilitation” and “palliative care” lead to misunderstanding about the importance of this area in comprehensive oncological therapy. This results in uncertainty in organizational and financial matters. To optimize regulatory oversight, ‘supportive therapy’ should become an integral component of modern oncological disease management, implying both interdisciplinary cooperation and a transparent financial system, the adequacy of which will depend on what is included in this concept.

Romanova T.E., Abaeva O.P., Romanov S.V., Dzyubak S.A.

In addition to officially authorized information resources, doctors of medical organizations widely use publicly available means of digital communication in professional communication with patients, which poses a threat to the disclosure of personal data and information about the patient’s health status.Aim. To study the frequency of use of publicly available digital means of communication by doctors in professional communication with patients.Materials and methods. A survey based on author’s questionnaires of 240 doctors, among whom 36.6 ± 3.1% worked in a polyclinic, 18.3 ± 2.4% – in a rural hospital, 45.1 ± 3.2% – in a multidisciplinary urban hospital. Among the respondents were representatives of various age groups and medical specialties.Results. According to the survey results, only 18.2 ± 2.5% of respondents do not use publicly available digital technologies when communicating with patients. Doctors mainly use messengers (Whatsapp, Viber and others) (44.6 ± 3.2% of respondents), e-mail (24.5 ± 2.8%), less often social networks (12.6 ± 2.1%). As doctors move into older age groups, they use digital technologies less often to communicate with patients (p = 0.045), communication with patients using digital means of communication is more common among male doctors than among female doctors (p = 0.04). The number of doctors using digital technologies in communicating with patients in the city hospital turned out to be significantly higher compared to the central district hospital (p < 0.0001) and polyclinic (p < 0.0001). Doctors of therapeutic specialties are less likely to use digital technologies to communicate with a patient than specialists in surgical specialties (p = 0.04).Conclusion. The results of the study indicate a high prevalence of the use of publicly available digital communication tools by doctors when communicating with patients: 81.8 ± 2.5% of respondents reported such a practice. At the same time, such unsecured communication channels as messengers and e-mail are the most in demand.

Murashko M.A., Panin A.I., Chigrina V.P., Tyufilin D.S., Khodakova O.V., Deev I.A., Kobyakova O.S.

The global telemedicine technology (TMT) regulatory landscape is currently evolving in a number of ways. The goal is to carry out an analytical examination of the institutional and legal frameworks for medical treatment including telemedicine consultation (TMC) in Russian Federation and foreign countries. The regulatory legal regulation of 22 international healthcare systems was included in the final version of the review. The review’s findings allow for the identification of the most important organizational and legal facets of delivering healthcare via TMC abroad: the majority of foreign nations lack comprehensive legal regulations governing the use of TMT in healthcare; the ability to establish a diagnosis within the context of TMC only follows an initial in-person consultation with a doctor; conducting TMC exclusively by licensed medical professionals and medical organizations; the option to conduct TMC via government-designed platforms and publicly accessible information platforms; requiring the patient to be informed about the benefits and drawbacks of TMT prior to consultation and to provide written or verbal informed consent; and requiring adherence to standards and recommendations during TMC, application, and in-person admission of the patient. The analysis demonstrates how commonplace TMC is abroad. However, there are currently no well-defined organizational or regulatory requirements for the use of TMC in the delivery of medical care, which calls for additional research into global experience and the identification of best practices that may be expanded throughout the Russian Federation.

Biryukova N.V., Butareva M.M.

The development of a human health culture is a complex health issue that requires the establishment of a system of health education and training from an early age. The duration and complexity of developing a culture of healthy living require scientifically based, targeted and systematic interventions on adolescents to develop behaviours that ensure a high level of health culture. The lack of a common definition of a health culture limits its quantification and comparison. In the course of the work, a theoretical analysis of the scientific literature was conducted to study the diversity of approaches to the evaluation of the culture of adolescent health. The most common methods of studying health culture are given. It has been revealed that to assess the level of health culture from the medical point of view there is a certain lack of complex theoretical approaches and instrumental methods that could allow to assess the studied phenomenon taking into account all its diversity. A synthesis of experiences and analysis shows that there is a need to develop a universal system of evaluation of adolescent health culture with a high adaptive capacity and the ability to adapt to any group of adolescents.

Gadzhieva S.M.

   The large-scale transformation of the capital’s healthcare system included the creation of competence centers to provide citizens with affordable and high-quality medical care in the most popular fields, including oncology. To provide medical care to patients with neoplasms in a full cycle, outpatient cancer care centers were included in the structure of cancer centers.   Aim. To analyze Moscow’s experience in launching competence centers using the example of creating outpatient cancer care centers.   Materials and methods. In the course of the research, a content analysis of literary data and regulatory legal acts of the Moscow Healthcare Department was used. The analysis of indicators of primary morbidity of the entire population (A00-T98) and by class of neoplasm (C00-D48) in Russia as a whole, the Central Federal District according to Rosstat and Moscow. A sociological method was used in the form of a survey and questionnaire of patients.   Results. The number of all registered diseases in the medical organizations of the Moscow Healthcare Department in 2022 amounted to 752.4 cases per 1000 population, which is lower than in Russia and the Central Federal District. The number of registered malignant neoplasms in 2022 was 12.0 cases per 1000 population, which is higher than the average for Russia and the Central Federal District. In Moscow, in 2022, for the first time, 65 % of patients with malignant neoplasms detected at stages I and II were registered at the dispensary. The proportion of patients registered for 5 years or more in 2022 was 58.7 %.   Conclusion. At the moment, the system of organization of oncological care is a set of structures that combine all stages of care: from diagnosis to follow-up. Monitoring of diagnostic and treatment results at the level of the patient and the entire organization as a whole is carried out continuously and is the basis for evaluating the achievement of performance indicators.

Sizov G.G.

   The modern appearance of the Moscow digital clinic was mainly set in 2011 in the context of complex changes in the city management system, which subsequently took the form of the Moscow city development concept “Smart City – 2030”. The initial goals for changing primary health care included providing Muscovites with access to information and communication technologies in medical organizations, eliminating fragmentation and duplication of functions, and ensuring compatibility of data used in various information systems.   Aim. To identify and describe step-by-step changes in the organization of primary health care in Moscow, related to the introduction of digital technologies and aimed at improving the organizational forms and methods of operation of public medical institutions in the capital, improving the access of the urban population to timely and high-quality medical care.   Materials and methods. An analysis of regulatory legal acts and scientific literature was carried out in the “manual search” mode for the period 2011–2024.   Results. Informatization of key processes in primary healthcare in the capital has reduced the waiting time for patients to receive an appointment. The number of people waiting 4 days or more to see a therapist has dropped to 2 %. An AIDS based on artificial intelligence was introduced into the practice of primary care doctors, available in all adult clinics in Moscow. Telemedicine services were provided for patients with COVID-19, which were subsequently expanded to other categories of patients.   Conclusion. A review of data related to the digitalization of healthcare shows that changes in the work of clinics of the Moscow public health system are best practices that correspond to the practices of leading foreign countries, partly surpassing them in the systematicity of urban management issues.

Gusev A.V., Artemova O.R., Andreychenko A.E., Ivanov I.V.

   According to the recommendations of The International Medical Device Regulators Forum (IMDRF), software intended for medical purposes falls under the category of medical devices (MD). In recent years, in Russia, a great deal of systematic work has been carried out to establish normative regulations and processes for controlling the efficiency and safety ofsoftware as medical devices (SaMD) and its subsequent state registration.   Objective. The analysis of current procedures and results of state registration of SaMD in the Russian Federation in 2007–2024.   Materials and methods. A systematic search of information on the software registered in Russia as MD was carried out. For this, the state registry of MD of the Federal Service for Surveillance in Healthcare of Russia (Roszdravnadzor) was used. 157 records of marketing authorizations (MA) issued between 01. 01. 2007 and 30. 07. 2024 were found.   Results. 25.5 % of MAs were issued for radiological information systems, including image archiving and communication systems (PACS-systems). For SaMD with artificial intelligence technologies – 24.2 % MAs. 13.4 % of MAs were issued for laboratory information systems and 4.5 % for medical information systems of medical organizations. The “Other software” group accounted for 32.5 %, it included telemedicine solutions, software for planning surgeries, etc. More than 50 % of Mas for SaMD was issued for Russian-based developers. Half of SaMD was registered as the 2nd class of potential risk application (50 %), 17 % as the class 2b, and 18 % as the lowest 1st class of potential risk. 15 % of SaMD were of the maximum 3rd class of the potential risk of application, and most of them were SaMD with artificial intelligence (AI) technologies.   Conclusion. In Russia, a system of independent testing and state registration of SaMD has been built and has been working reliably for many years, allowing manufacturers to bring to the market the most diverse products, including innovative AI-based MD. Russian development companies are gradually increasing their market share compared to foreign producers.

Khripun A.I.

   In modern socio-political and socio-economic conditions, the task of preserving, strengthening and improving the health of the population of any city, especially the capital, is becoming extremely relevant and important. The capital’s healthcare system implements a state policy in the field of healthcare, providing the necessary conditions for providing citizens with affordable and high-quality medical care.   Aim. Describe the main approaches to the modernization of Moscow healthcare, taking into account the pace of development of the megalopolis infrastructure and the needs of its residents in high-quality and affordable medical care.   Materials and methods. The analysis of the general morbidity and by classes of diseases, the average number of visits per resident per year by disease, resource provision and activities of medical organizations subordinate to the Moscow Healthcare Department according to federal forms of statistical observation for 2018–2022 was carried out.   Results. Against the background of an increase in the general morbidity of adults in the Russian Federation (by 10.4 %), a similar trend is observed in Moscow (by 4.8 % in 2022 compared to 2021). Currently, a number of projects aimed at transforming and modernizing the current healthcare system are being implemented in the capital, thanks to the implementation of which in recent years Moscow has managed to achieve the targets of the Capital Healthcare program and significantly exceed similar national averages – for the period 2010–2022, life expectancy has increased from 74.2 years to 78.2 years; for the period 2018–2022, primary morbidity has significantly decreased (for example, diseases of the digestive system – by more than 28 %, diseases of the musculoskeletal system – by more than 30 %); waiting time for admission by a doctor in the polyclinic network has been reduced by 3.3 times. Including an increase in the average number of visits per resident (8.4) compared to 2018 – by 3.7 %.   Conclusion. Modernization of the capital’s medicine is carried out at the level of technical equipment, staffing and organizational solutions. New management technologies include an integrated approach to infrastructure modernization, building scalable processes and maximum automation, which requires both an integrated approach within the Moscow Healthcare Department and intersectoral cooperation.

Starshinin A.V.

   The increase in the number of chronic noncommunicable diseases, changes in the age structure of the population, and an increase in demand for medical services in the primary health care system determine the need for an adequate response of health systems to these requests. Standardization is one of the effective mechanisms for managing the quality and accessibility of medical care provided to the population. The development of the Moscow healthcare system today is focused on the redistribution of forces towards primary healthcare and large-scale digitalization.   Aim. To evaluate the results of the implementation of standardized solutions in the primary health care management system provided in outpatient clinics subordinate to the Department of Health of the city of Moscow.   Materials and methods. Statistical and analytical methods, the method of expert interviews and content analysis of literature sources of domestic authors, as well as normative legal acts for 2018-2023 were used in the work. The main performance indicators of the outpatient clinics of Moscow are analyzed.   Results. Important purposes of the healthcare system have been achieved: the created modern framework of outpatient care provided the opportunity to ensure equal access to quality care; the introduction of a single standard of polyclinics contributes to the rationalization of territorial planning, improvement and development of infrastructure, the use of innovative medical technologies and solutions; managerial and reorganization changes in the structure of polyclinics allowed to build convenient and clear routing of patients to receive medical care in the required volume and shorter terms. Changes in the Moscow primary health care system affect both external and internal processes, are aimed at maximizing the coverage of the population with health services, improving the provision of modern equipment to Moscow polyclinics, and creating a digital polyclinic.   Conclusion. Bringing Moscow polyclinics to a single standard required reengineering of existing processes, restructuring of procedures focused on managing the completed case. The quality and accessibility of medical care to the population of Moscow remains a top priority in the development of outpatient care.

Orlova N.V., Suvorov G.N., Karseladze N.D., Yakushev Y.Y., Gololobova T.V.

The growth of digitalization in medicine has significantly expanded the possibilities of using big data in pharmacoepidemiology. The use of big data makes it possible to reduce the cost of clinical research, increase the speed of recruitment and expand the sample, makes it possible to evaluate the effect of drugs in pregnant women and effectiveness in rare diseases. The databases PubMed, Scopus, Web of Science and Google Scholar for 12 years from 2012 to 2023, United Nations documents, World Health Organization, Federal laws of the Russian Federation in the field of artificial intelligence, protection of confidential information, and clinical research were analyzed. The search was carried out by keywords: «big data», «registers», «pharmacoepidemiology», «personal data», «legal regulation», «protection methods». The article provides examples of the use of big data in healthcare, including from 25 to 50 million people. The analysis of the literature data revealed the same type of problems – the lack of uniformity in the introduction of information, incomplete information, limited availability. The review identifies the problems of protecting the confidentiality of information. The mechanisms of information standardization, storage, and data processing are considered. The international and Russian legislative framework regulating the conduct of clinical trials using big data is presented.

Prialukhin I.A., Sheshko E.L., Seryapina Y.V., Plutnitskiy A.N., Pugachev P.S., Omelyanovskiy V.V., Artemova O.R., Pugacheva T.V., Dolgushina N.V., Verhovtsev A.A., Akhapkina E.S., Kirpa-Ivanov T.A., Sukhikh G.T.

The article presents the experience of the «National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov» in creation of medical guidelines based on the patient’s route business process for vertically integrated medical information system for “Obstetrics and gynecology” and “Neonatology” (VIMIS “AKiNEO”), with simultaneous digitization of the document, describes the advantages of this an approach before the classical form of writing document.Aim. To conduct a comparative analysis of approaches to writing a medical guideline based on a digitized medical guideline and patient’s route business process for VIMIS “AKiNEO” and in the classical way.Materials and methods. The content of digitized medical guidelines and procedures for the provision of medical care, formed by experts on the basis of the “National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov” with the methodological support of the Center for Healthcare Quality Assessment and Control were used. The assessment of the methodological advantages of writing medical guidelines based on patient routes business processes in comparison with writing in the classical way was carried out using methods of analysis and synthesis.Results. Experts have created 17 patient routes using the content of digitized medical guidelines for immersion in the VIMIS “AKiNEO”. These routes fully reflect the amount and timing of medical interventions necessary to ensure the quality of medical care. Methodological approaches for writing medical guidelines based patient routes business processes have been developed. It has been demonstrated that digitizing the content of medical guidelines and medical care procedures, describing medical guidelines in the form of a business process diagram, identify “zones of uncertainty” that ar e not visible in the text document, and can significantly affec t the quality of medical care to the patient.Conclusion. The creation of regulatory legal acts on the organization and provision of medical care and medical guidelines in modern conditions of healthcare digital transformation should take place after digitizing the text of the document and creating a business process for the patient’s route, which will improve the quality of these documents.

Biryukova N.V., Khalfin R.A., Madyanova V.V.

Pre-professional medical education in high school provides not only a more in-depth study of individual subjects of general education programs, but also expands the opportunities for self-determination of students, ensures continuity of the educational process, allows boys and girls to adapt more successfully mastering higher medical professional education programs and is the basis for a successful career.Aim. To evaluate the results of the introduction and implementation of the model of pre-professional medical and pharmaceutical education using the example of the Resource Center «Medical Sechenov Pre-University» of the Sechenov First Moscow State Medical University (Sechenov University) (hereinafter referred to as the Pre-University) as a means of developing the human resources potential of the healthcare system on the territory of the Russian Federation.Materials and methods. During the work, a theoretical analysis of domestic and foreign literature on the problem of developing the human resources potential of the healthcare system was carried out. A study was conducted in the comparative aspect of the basic readiness of students in grades 8-11 at the Pre-University and specialized medical and biological classes of regional educational institutions to the choice of medical specialties using a test questionnaire with the identification of three key aspects: readiness to master medical specialties; self-assessment of capabilities and erudition in the field of modern medicine. 1465 people took part in the survey. The reliability of the results was carried using the Mann-Whitney U test. Assessment of the statistical significance of differences between the means was carried out at a critical level of p = 0.05.Results. Studying at the Pre-University of Sechenov University allowed the majority of adolescents to achieve higher levels of formation of the main indicators of basic readiness to choose medical specialties. The share of students with a high level of readiness to master medical specialties at the Pre-University is 13.8 % higher compared to students of specialized medical and biological classes, with high erudition – 13.8 % and 6.7 % higher those who highly assess their prospects for entering a medical university.Conclusion. Pre-professional education based on close interaction between the Pre-University and Sechenov University allows students to develop motivation to choose a medical profession, as well as a clear understanding of the learning process in the chosen profession and is an important link in the system of continuous educational trajectory «pre-university–university–clinic».

Shepel R.N., Samorodskaya I.V., Kakorina E.P., Drapkina O.M.

Aim: to examine the opinions of healthcare professionals on using codes from the ICD-10 group chronic ischemic heart disease (CIHD) (I25.0, I25.1, I25.8, I25.9) as the primary cause of death and discuss the results in the context of comparing with regional variability of standardized mortality ratio (SMR) from different forms of CIHD.Materials and methods. A one-stage study was conducted. This article describes the results of a survey of 366 medical workers (cardiologists, internists/general practitioners/family doctors, pathologists, public health and healthcare specialists, paramedics) from 47 subjects of the Russian Federation who fill out a medical death certificate (MDS) more often than 2–3 times a month. In addition, SMR from coronary heart disease were determined based on a brief nomenclature of causes of death of Rosstat in 82 regions of the Russian Federation for 2022.Results. 80.1 % of respondents expressed the opinion that I25.0, I25.1, I25.8, I25.9 are necessary for coding causes of death, but half of those surveyed do not see any differences in them. At the same time, respondents admit the possibility of using these CIHD codes as the primary cause of death without ante-mortem and pathological verification. The relatively small coefficient of variation of SMR overall from CIHD (34.19 per 100,000 population) is associated with high values from its individual forms: the coefficient of variation of average regional SMRs ranged from 62 % for code I25.1 to 174 % for code I25.0.Conclusions. The results of this study indicate a variable attitude of specialists filling out MSD towards choosing ICD-10 codes from the CIHD group, leading to significant interregional differences in CIHD mortality rates. It is necessary to develop unified recommendations describing situations in which codes from the CIHD group can be considered the primary (main) cause of death.

Gusev A.V., Artemova O.R., Vasiliev Y.A., Vladzymyrskyy A.V.

Introduction. Healthcare is one of the priority sectors for the deployment of artificial intelligence (AI) technologies worldwide, including Russia. A key area of AI deployment is the integration of AI-base software as a medical device (AI SaMD) into the Unified digital systems of the healthcare sector of the Russian Federation.Aim. Research of the results of the deployment of AI SaMD in healthcare of the Russian Federation in 2023.Materials and methods. The State Register of Medical Devices and Organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices was used as information about AI SaMD registered in Russia. As information on the deployment of AI SaMD, data from monitoring to the federal project “Creating a single digital system in healthcare” was used, including reports from constituent entities of the Russian Federation upon these activities. The results of the implementation of AI SaMD in Moscow were obtained according to data from the Moscow Department of Health as part of an experiment on the use of innovative technologies in the field of computer vision for the analysis of medical images.Results. As of January 1, 2024, Roszdravnadzor registered 26 AI SaMD, 77 % of them were developed by 13 Russian companies. At the end of 2023, 84 (94 %) constituent entities of the Russian Federation met the minimum established target for the purchase of AI SaMD. Within the framework of public procurement procedures provided by law, 106 government contracts were signed for the purchase and deployment of AI SaMD for a total amount of 448 million 430 thousand rubles.Conclusion. In 2023, the Russian healthcare system made a significant breakthrough in terms of the practical deployment of AI SaMD. Completed procurement and deployment projects are the basis for subsequent industry development.