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This book mainly introduces the concepts and approaches of global governance from the viewpoints of Chinese and Russian scholars and is divided into four parts. The first one deals with the concept of a new type of global governance, namely "Globalization 2.0". The second one is dedicated to institutions and multilateralism, including the importance and effectiveness of international institutions. The third part focuses on the important countries and regions in the new era, as well as such issues as the current global status quo, processes in Eurasia, the prospects of the U.S.-China-Russia trilateral relationship. The last part analyzes the future development of global governance and possible solutions of how it might be improved. Climate change, digital era, cyber security, financial and economic regimes, COVID-19 are all involved in this part. In short, this book is a profound and cutting-edge research on global governance. © China Social Sciences Press 2023.
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Compared to other respiratory viruses, the proportion of hospitalizations due to SARS-CoV-2 among children is relatively low. While severe illness is not common among children and young individuals, a particular type of severe condition called multisystem inflammatory syndrome in children (MIS-C) has been reported. The aim of this prospective cohort study, which followed a group of individuals under the age of 19, was to examine the characteristics of patients who had contracted SARS-CoV-2, including their coexisting medical conditions, clinical symptoms, laboratory findings, and outcomes. The study also aimed to investigate the features of children who met the WHO case definition of MIS-C, as well as those who required intensive care. A total of 270 patients were included between March 2020 and December 2021. The eligible criteria were individuals between 0-18 with a confirmed SARS-CoV-2 infection at the Infectious Disease Hospital "Prof. Ivan Kirov"in Sofia, Bulgaria. Nearly 76% of the patients were <= 12 years old. In our study, at least one comorbidity was reported in 28.1% of the cases, with obesity being the most common one (8.9%). Less than 5% of children were transferred to an intensive care unit. We observed a statistically significant difference in the age groups, with children between 5 and 12 years old having a higher likelihood of requiring intensive care compared to other age groups. The median values of PaO2 and SatO2 were higher among patients admitted to the standard ward, while the values of granulocytes and C-reactive protein were higher among those transferred to the intensive care unit. Additionally, we identified 26 children who met the WHO case definition for MIS-C. Our study data supports the evidence of milder COVID-19 in children and young individuals as compared to adults. Older age groups were associated with higher incidence of both MIS-C and ICU admissions.Copyright © 2023 P. Velikov et al., published by Sciendo.
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The objective of this study was to assess the volume of consumption of anti-interleukins and janus kinase inhibitors in the period 2018–2021, used as well as preventive pathogenetic therapy of COVID-19.Materials and methods. Based on actual sales data in the segments of public procurement (including regional and federal preferential drug provision) and retail sales segment in the period 2018–2021, obtained from the IQVIA database. All data was recalculated into the number of established daily doses (DDDs), with the calculation of pharmacoepidemiological indicators «Incidence of prescribing drugs», «Cumulative risk of prescribing drugs», as well as «Prescribing prevalence per year» for tocilizumab, olokizumab, levilimab, sarilumab, kanakinumab, anakinra, baricitinib, tofacitinib and upadacitinib. Results and discussion. The growth of total sales volumes was demonstrated in all market segments, but mostly in the segment of regional purchases, primarily related to the purchase of these groups of medicines for COVID-19 therapy in the period 2020–2021. It was demonstrated that the increase in the number of cases, accompanied by the expansion of prescribing preventive pathogenetic therapy, led to a twofold increase in the number of new cases of prescribing of janus kinase inhibitors and an increase in this indicator for anti-interleukins by 1.5 times, taking into account the estimated number of patients with moderate and severe COVID-19. The cumulative risk of prescribing these classes of drugs increased proportionally: for JAK inhibitors from 14 to 32%, and for anti-IL drugs from 38 to 69%. Calculations showed that the proportion of people over 18 years of age in the Russian Federation who received at least one dose of janus kinase inhibitors and anti-interleukins increased many times, in 1000 times and 500 times. Conclusions. Taking into account the expansion of the use of these groups of medicines, careful monitoring of information about their safety is required. © 2023, HIV Infection and Immunosuppressive Disorders.All Rights Reserved.
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Objective: evaluation of the clinical and economic efficiency of using Levilimab in the treatment of moderate and severe COVID-19 based on real world data (RWD). Material and methods. A single-center observational retrospective case-control study was performed. According to the matching algorithm, 834 pairs of patients with moderate and 347 pairs with severe infection were selected, similar in gender, age, vaccination status, severity of the disease and the level of C-reactive protein. Results. The clinical efficiency of Levilimab with respect to in-hospital mortality was demonstrated both for the moderate course (6% in the Levilimab group and 10% in the standard therapy group;odds ratio (OR) 1.71;95% confidence interval (CI) 1.19-2.47;p<0.01) and for the severe course of COVID-19 (63% and 82%, respectively;OR 2.70;95% CI 1.90-3.82;p<0.01). The costs per 1 treated patient were also higher in the Levilimab therapy groups: the difference in costs compared to the standard therapy group for patients with moderate disease was 54 665.30 rubles, with severe disease - 91 285.85 rubles. The estimated cost of the additional effectiveness of Levilimab for the moderate course of the disease was 13, 666.32 rubles, for the severe course - 4, 804.51 rubles. Conclusion. The use of Levilimab for the treatment of moderate and severe COVID-19 is feasible both from a clinical and economic points of view. Conducting RWD trials is an important tool to understand the effectiveness of medical technologies in real clinical practice.Copyright © 2023 IRBIS LLC. All Rights Reserved.
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Tourism suffered more than many other sectors amid COVID-19 travel restrictions. This article looks at the impact of the pandemic on the territorial redistribution of tourist flows in the Baltic region. The study draws on regional annual and monthly data on international and domestic tourist arrivals between 2019 and 2021, available on the websites of the statistical offices of the Baltic Region countries. The regions earlier dependent on tourist arrivals from Russia experienced the largest drop in inbound tourism during the COVID-19 pandemic. Yet, domestic tourism burgeoned in most of the region's countries. In 2021, the most dramatic increase in domestic arrivals occurred, year on year, in the border regions of Russia's Northwest Federal District;the growth was also notable in Finland and the Baltic States. Domestic tourist flow compensated, partially or even fully, for the decrease in inbound tourist flow in most regions. The structure of inbound tourism changed markedly during the pandemic, with the share of tourists from the Baltic States growing. The strongest rise was in some regions of southern Finland and more modest in Latvia and Lithuania © Manakov, A. G., Krastev, V. K., Krasilnikova, I. N., Ivanov, I. A., 2023
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Introduction. Extracorporeal membrane oxygenation has found wide application in clinical practice during the COVID-19 pandemic. Oxidative stress, endothelial dysfunction, and systemic inflammatory response syndrome play an important role in the pathogenesis of COVID-19. Our research was designed to study correlations in-between those factors and the impact of extracorporeal membrane oxygenation on them. Aim. The study of systemic inflammatory response and endothelial function in patients with COVID-19 during extracorporeal membrane oxygenation. Material and methods. In the course of a prospective study, we examined 100 COVID-19 patients aged 26 to 75 years, median 55 years [47;60], who were treated at the N.V. Sklifosovsky Research Institute for Emergency Medicine, using extracorporeal membrane oxygenation. As a control group (normal), 25 practically healthy people whose median age was 32 years [25;39] were examined. The function of the vascular endothelium was assessed by the content of nitric oxide stable metabolites in the blood serum and the level of angiotensin-converting enzyme. Next, the ratio of nitric oxide metabolite to angiotensin-converting enzyme level was calculated, reflecting the imbalance between endothelium-dependent vasodilation and vasoconstriction. To assess the severity of oxidative stress in blood serum, malondialdehyde was determined as a marker of lipid peroxidation. The state of the antioxidant system was assessed in terms of total antioxidant status of blood serum. The presence of an imbalance in the system of lipid peroxidation and the antioxidant system total antioxidant status was judged by the oxidative stress coefficient, i.e. the ratio of malondialdehyde to the total antioxidant activity. Results. The analysis showed the presence and progression of endothelial dysfunction, impaired vascular regulation, activation of free radical processes, the presence of an imbalance in the prooxidant/antioxidant system, as well as the progression of the inflammatory process with a decrease in the level of markers of the COVID-19 severity. Conclusion. Further studies of the correlation between endothelial damage and the severity of the systemic inflammatory response syndrome may be of fundamental importance for explaining the pathophysiological mechanisms of COVID-19 course and developing new treatments for such patients. © 2023 Sklifosovsky Research Institute for Emergency Medicine. All rights reserved.
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Objective. To evaluate safety of anti-interleukin drugs used as a pathogenetic therapy of COVID-19 as assessed by risks of infectious complications. Materials and methods. A systematic review of publications related to safety assessment of anti-interleukin drugs recommended as pathogenetic therapy in COVID-19 patients in terms of incidence of serious adverse events and adverse events of "Infections and Invasions" class and a meta-analysis of the data were performed. Results. The meta-analysis included 16 randomized and 3 non-randomized studies. The hazard ratio of serious adverse events between the comparison groups was 0.93 [95% CI 0.85;1.01] (p = 0.1), the hazard ratio of adverse event of "Infections and Invasions" class was 0.9 [95% CI 0.8;1.02] (p = 0.09), showing no differences in the incidence of those events. Conclusions. This meta-analysis did not demonstrate statistically significant differences in the relative risks of serious adverse events and adverse events of "Infections and Invasions" class for the use of anti-interleukin drugs in COVID-19 patients.Copyright © 2022, Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy. All rights reserved.
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Background: UMHATEM N.I. Pirogov" Sofia, is one of the largest and busiest hospitals for emergency medical care in Bulgaria. It is the legal successor of the former Institute of Emergency Medicine N.I. Pirogov", and it can be said that at the moment it is the only diagnostic-therapeutic, prophylactic and scientific-educational structure of this type within the Bulgarian healthcare system. The concept of adequate functioning and development of this type of hospital does not consider structuring an Infectious Diseases diagnostic-treatment unit. This reality makes necessary the formation of a radically different organization for the admission and treatment of patients in the hospital, both for those with symptoms of Covid 19 and for all other emergency patients. The organization created in this way must absolutely guarantee safety for both streams of patients. In the conditions of a pandemic, in case of a real threat to public health, the main task of triage in the Emergency Department is to establish indications for urgent hospitalization, or to refuse it in the absence of indications. The characteristic course of the disease, the prolonged treatment, the manifestations within the so-called post-Covid syndrome", require serious planning not only of the diagnostic-treatment and rehabilitation period, but also adequate monitoring in the first months after the patient's discharge. Within the national reorganization measures, during the determined periods, the main changes concerning the MED (Multi-profile emergency department) of Pirogov are implemented, with an emphasis on the formation of a specialized triage for the diagnosis and clinical evaluation of patients with a coronavirus infection. The main goal is the adequate diagnosis, treatment and follow-up of patients with coronavirus infection who have passed through the organized Covid-triage in a period of extreme pressure on the emergency structures and on the hospital system in the country as a whole. Objective(s): For a MED, which at the time of declaring an epidemic situation does not have a concept for the diagnosis and treatment of infectious diseases, to systematize the main urgently implemented organizational and structural changes, which turned out to be absolutely necessary to meet a newly emerging epidemiologically significant infectious disease. Aim(s): To systematize the organizational changes imposed by the situation and urgently implemented in the MED (multi-profile emergency department). To systematize the structural changes imposed by the situation and urgently implemented in the work of the MED. To analyze the organizational and structural changes carried out in this way and to differentiate the main difficulties caused by the regulations existing at the time of the announcement of the epidemic situationCopyright © Pantileeva D et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
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Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
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One of the most pressing public health problems is the misuse of antibiotics, especially in industrialized countries. In addition to antibiotic resistance, a disease associated with this abuse is Clostridioides difficile infection (CDI). It is also a serious problem in long-term hospital treatment, as it often causes intra-hospital infections. The coronavirus disease 2019 (COVID-19) pandemic has also led to widespread misuse of antibiotics and prolonged hospitalizations. The aim of our study was to compare two groups of patients who developed CDI before and during the COVID-19 pandemic, respectively. A total of 246 CDI patients with an average age of 58 years were studied for the period of March-August 2021, who also recovered from COVID-19. They were compared with another group of CDI patients who had become ill in the period before COVID-19. We found an increase in CDI patients for the period of the COVID-19 pandemic by 21.95%. Patients with CDI associated with COVID-19 were older, with higher rates of neurologic, tumor and cardiovascular disease, and with metabolic syndrome. In the group with COVID-19 CDI, there was higher use of proton pump inhibitors, use of antibiotics and significantly higher use of corticosteroids. All these factors lead to the conclusion that increased caution is needed in patients with COVID-19 and that mandatory testing should be done for C. difficile infection at the onset of the diarrheal syndrome.
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Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data. Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
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Extracorporeal membrane oxygenation (ECMO) is a method that makes it possible to compensate for critical changes caused by acute respiratory failure, with the ineffectiveness of treatment with rigid modes of artificial lung ventilation (ventilator) in patients with acute respiratory distress syndrome in intensive care units. The search for the optimal state of the hemostasis system is one of the main tasks in the treatment of critical patients in ECMO conditions. The objective: to study changes in hemostatic parameters in patients with COVID-19 undergoing ECMO and determine the need for their correction. Subjects and Methods. According to the inclusion and exclusion criteria, 100 patients were included in the study: 72 men and 28 women aged 26 to 75 years old, the median age made 55 years [47;60]. VV-ECMO was performed in all observations. In 100% of cases, the cause of respiratory failure which required VV-ECMO was COVID-19-associated pneumonia. Results. 49 episodes of hemorrhagic complications and 76 episodes of thrombotic complications were recorded from the 1st to the 7th day from the moment of ECMO initiation. We found that the chance of developing thrombosis decreased by an average of 0.3% with an increase in the activity of antithrombin-3 by 1%. A statistically significant association of thrombosis risk was also found for prothrombin and prothrombin time. Conclusion. During the first 7 days of ECMO, patients with COVID-19 demonstrate the increase in APTT, prothrombin time and a decrease in the number of platelets, prothrombin activity, and fibrinogen concentration. The risk of thrombosis in this group of patients significantly decreases with the increasing activity of antithrombin-3 and prothrombin and increases with rising need of the higher dose of unfractionated heparin. The tactics of restrictive anticoagulant therapy when using unfractionated heparin can be taken into account as a way to reduce the risk of thrombosis and requires further research. © 2022 The authors.
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Background: Extracorporeal membrane oxygenation's (ECMO) support causes various hemostatic disorders that are poorly understood, especially in COVID-19 patients with severe acute respiratory distress syndrome (ARDS) Aims: To assess changes in hemostasis parameters during and without ECMO support in COVID-19 patients with severe ARDS Methods: A prospective study of 122 patients with a severe course of COVID-19 was carried out. The average age was 59 +/- 12 years. The patients' condition, assessed by the NEWS and SOFA severity score, was 4.5 +/- 1.4 and 6.1 +/- 1.3 points, respectively. Retro-prospective study of 130 patients with a severe course of COVID-19 requiring the use of ECMO was carried out. The average age of patients was 55 +/- 6 years. The patients' condition, assessed by the RESP and SOFA severity score, was 1 +/- 2 and 10 +/- 2 points respectively. Median ECMO duration was 8 [IQR 4-14] days and median time from intubation to ECMO start was 1 [IQR 1-3] day. All patients were examined for PT, FG, Pr C, AT III, D-dimer and platelet count. The research was performed on day 1 and 7 after ECMO application. Statistical analysis was carried out using Statistica 10.0 software. Result(s): On day 1 patients with ECMO showed a significant decrease in the level of FG, PT, platelet count and the activity of AT III (p < 0.05) and an increase in the level of D-dimer (p < 0.05). On day 7 there was also a decrease in the level of FG and PT, the activity of AT III, Pr C and an increase in the level of D-dimer. Conclusion(s): ECMO triggers early activation of coagulation, which leads to the consumption of FG, PT and platelets, followed by hypofibrinogenemia and thrombocytopenia that may possibly contribute to the high rate of hemorrhagic complications. On the other hand, a decrease in the activity of AT III and Pr C may contribute to thrombotic complications.
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Objective. To evaluate safety of anti-interleukin drugs used as a pathogenetic therapy of COVID-19 as assessed by risks of infectious complications. Materials and methods. A systematic review of publications related to safety assessment of anti-interleukin drugs recommended as pathogenetic therapy in COVID-19 patients in terms of incidence of serious adverse events and adverse events of “Infections and Invasions” class and a meta-analysis of the data were performed. Results. The meta-analysis included 16 randomized and 3 non-randomized studies. The hazard ratio of serious adverse events between the comparison groups was 0.93 [95% CI 0.85;1.01] (p = 0.1), the hazard ratio of adverse event of “Infections and Invasions” class was 0.9 [95% CI 0.8;1.02] (p = 0.09), showing no differences in the incidence of those events. Conclusions. This meta-analysis did not demonstrate statistically significant differences in the relative risks of serious adverse events and adverse events of “Infections and Invasions” class for the use of anti-interleukin drugs in COVID-19 patients. © 2022, Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy. All rights reserved.
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The Advisory Board chaired by the chief specialist in infectious diseases of the Ministry of Health of Russian Federation, Professor V.P. Chulanov was held on June 18, 2022 in Saint Petersburg. Aim. The main purpose of the Board was following discussion: the analysis of the real-world data of levilimab as an anticipatory therapy for COVID-19 in hospitalized patients; the review of the experience and perspectives of levilimab as an anticipatory anti-inflammatory option for outpatient patients who meet defined clinical and laboratory criteria. Results. The analyzed data on clinical efficacy and safety formed the basis of recommendations proposed by experts for the use of levilimab in the inpatient and outpatient medical care for COVID-19.
Subject(s)
COVID-19 Drug Treatment , Humans , Antibodies, Monoclonal, Humanized/therapeutic use , Anti-Inflammatory Agents , Receptors, Interleukin-6ABSTRACT
The aim of current study was to determine, retrospectively, possible correlations between smoking and the incidence, course severity, intubation rate, and mortality (by gender and age) in patients treated for complicated coronavirus infection in the internal medicine clinic at UMHATEM ”N. I. Pirogov” Sofia for the period 01.03.2020–31.12.2020. In a prospective study, the recovery period and immunogenesis in smokers and non-smokers within a one-year period after hospital discharge was investigated. The applied methods were: 1) computed tomography and blood gas analysis 2) chemiluminescent immunoassay for the qualitative determination of total IgM, IgA and IgG anti-SARS-CoV2 AB. Results showed that the part of non-smokers with a positive PCR test is significantly higher compared to the group of former and current smokers. The data obtained from the study confirmed that Covid infection is much more severe among smokers and former smokers with a higher levels of inflammatory markers noticed among the smoking group.
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The paper investigates compliance with the EU fiscal rules in the period 1992–2020. The EU fiscal rules are prescribed as guidelines and represent a typical example of the soft law approach. The negative impact of the soft law approach is more visible after the periods of economic crisis (2008–2009;2020–2022). The non-compliance with the prescribed ceilings on the level of the budgetary deficit and public debt create instability and various adverse economic effects. In the paper it is shown that existing rules are not adequate for the job they were made for. It is shown that the design and enforcement of the rules are poor, and that actually the European Commission, the watchdog, is in fact a toothless dog. The goal of the paper is to present potential reform alternatives with the aim to contribute to the rees-tablishment of the sound fiscal framework in the EU. The paper is concluded with the proposal of a completely new approach for the fiscal rules reform – Growth-En-hancement Fiscal Policy Switch (GEFPS). © 2022 Pravni fakultet Univerziteta Union.
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Introduction. As defined by the Food and Drug Administration, real-world data (RWD) is data related to a patient's health and/or health care delivery, usually collected from various sources as part of real-world clinical practice research. Objective: to describe the feasible and the most sought-after designs of non-interventional real-world clinical practice trials that provide evidence for the efficacy and safety of drug administration in the therapy of novel coronavirus infection. Material and methods. A search strategy for the terms “COVID-19 AND real-life”, “COVID-19 AND real-data”, “COVID-19 AND real-world” was developed to extract articles published between December 1, 2020 and March 12, 2021 from the databases: PubMed/MEDLINE, the Cochrane Database of Systematic Reviews, and the ClinicalTrials.gov database. Results. The search yielded 137 non-repetitive articles, 32 of them were included in the review. All randomized clinical trials (pragmatic and simplified large ones), studies of the effectiveness of laboratory diagnostic methods, medical triage, social distancing and other sanitary and epidemiological measures to cope with the epidemic were excluded. Conclusion. High-quality, non-randomized RWD studies can enhance the external validity of registration randomized clinical trials by complementing them with a broader range of indicators, which is essential in supporting medical and public health decision-making in the COVID-19 pandemic.
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In the wake of the Covid-10 pandemic, the Baltic region saw a dramatic reduction in tourist flows in 2000—2021;the decrease was as much as tenfold in some destinations. This study aims to classify the 16 transboundary tourist and recreational mesoregions of the Baltic region according to 2019 tourist flows. The research evaluates, for the first time, the 2020—2021 decline in tourist flows across these regions. The main outcome of this study is grouping the mesoregions into three orders according to the size of 2019 tourist flows. Four mesoregions were assigned to the first order (with over 500,000 arrivals), three of them located in the southwest Baltic region;nine, the second order (from 100,000 to 500,000 arrivals);three, the third order (from 50,000 to 100,000 arrivals). The most substantial fall in tourist flows occurred in 2020—2021 in the mesoregins including Sweden and Russia and the least marked in those involving Denmark, Germany, Finland, Estonia and Latvia. The findings may help track the future restoration of transboundary tourist flows in the countries of the Baltic region. © Manakov, A. G., Krasilnikova, I. N., Ivanov, I. A., 2022