Elena V Verbitskaya | First Pavlov Saint Petersburg State Medical University (original) (raw)
Papers by Elena V Verbitskaya
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice, 2023
The review is focused on discussing new trends in DM, rethinking the evidence base medicine with ... more The review is focused on discussing new trends in DM, rethinking the evidence base medicine with an emphasis on demonstrating the efficacy and safety of new therapeutic agents and medical technologies, from gene editing to AI algorithms. At the same time, clinical trials of drugs are also not standing still, there is active development, new approaches, methods and designs are being developed. The process of drug development, registration and market launch of any drug takes a significant period of time, requires high financial costs and human resources. The gold standard of evidence-based medicine was initially considered to be RCTs, but at the same time, they have objective disadvantages: limited sample, inability to control all factors; insufficient follow-up time,negative impact on participants, inability to determine cause-and-effect relationships; limited measurement methods, limited budget and others. This review discusses the trends in the methodology of clinical research. The active implementation of new designs such as Adaptive Clinical Trials, "Master" protocols including Umbrella Study, Basket Study, Platform Studies, Master Observational Trials and the increased use of Single Patient Trials (N-of-1 trials) are allowing studies to become more efficient, relevant and applicable to real-life health care practice settings and patient-centered. In the review, we also look at both the pros and cons of the expanded use of biomarkers and Digital Endpoints in clinical trials and virtual clinical trials, which use mathematical models to study patient heterogeneity and its impact on various therapeutic questions. The process of expertise and regulatory approval continues to slow down the entry of drugs into the pharmaceutical market. The review considers changes in the approaches of regulators (FDA, EMEA and Russian Ministry of Health) to the drug registration procedure. The COVID-19 pandemic and sanctions have led to the need to expand the list of drugs with authorized accelerated registration. However, accelerated registration raises many questions regarding the sufficiency of the level of evidence and safety. As we can see a deep synthesis and integration of all available data is needed to achieve the next generation of evidence-based medicine. The major challenge in the next two decades will be to exploit the potential of multidimensional evidence generation by extracting, collating and generating large data sets of natural course of disease, genomics and all other omics analyses, all published clinical trials, RWD to provide next generation evidence.
Drug and Alcohol Dependence , 2017
sitivity to change. Notably, there was an average of 15 items or 9 min to complete each CAT, sign... more sitivity to change. Notably, there was an average of 15 items or 9 min to complete each CAT, significantly lower (p = 0.0002) than the original version. Conclusions: The IRT-calibrated ASI-MV CATs show promise as enhanced versions of the traditional ASI composite scores, and provide further evidence that adaptive testing based on IRT modelling could prove useful in developing highly precise measurement in the areas of addiction and mental health more broadly, as has been demonstrated in the educational field. Financial support: NIDA Grant No. R44A023322.
Профилактическая медицина, 2020
Introduction. Preclinical or clinical eating disorders may be an important risk factor for obesit... more Introduction. Preclinical or clinical eating disorders may be an important risk factor for obesity. Aim of this study-to analyze the incidence of eating disorders and their association with body mass (BM) parameters among respondents interested in BM correction. Material and methods. Data were obtained using an online survey (2013-2018), in which 27,769 respondents took part. The Eating Attitudes Test (EAT) was used to screen for eating disorders. Results. The average BM index (BMI) in men (Me=34.39 kg/m 2 , grade I-II obesity) was higher than in women (Me=30.48 kg/m 2 , p<0.01). High incidence of excess BM (29.3%), obesity grade I (27.8%) and grade II (15.5%) were registered. Grade III morbid obesity was found in 11.6% of cases. The average EAT score was 13.59±0.08 points. For men, mean values (Me=9 points) were lower than in women (Me=13 points, p<0.01). The proportion of respondents with high EAT scores (≥20) who had a high probability of eating disorders was 22.6% for respondents with excess BM, and 21.5, 21.8 and 22.7 for people with grade I, II and III obesity respectively. In total, 23% of women and 13% of men (p<0.0001) with excess BM and obesity, interested in BM correction, had eating disorders. Conclusion. The data obtained make it possible to assess the likely contribution of eating disorders to the formation of obesity with particular emphasis on a higher level of these diseases in women. Further studies of this issue may lead to the development of special preventive programs to detect and correct eating disorders among patients with excess BM and obesity.
KaÄ?estvennaâ kliniÄ?eskaâ praktika, 2018
Multinational Trials - Recommendations on the Translations Required, Approaches to Using the Same... more Multinational Trials - Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report Abstract. Objectives: With the internationalization of clinical trial programs, there is an increased need to translate and culturally adapt patient-reported outcome (PRO) measures. Although guidelines for good practices in translation and linguistic validation are available, the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Task Force identified a number of areas where they felt that further discussion around methods and best practices would be beneficial. The areas identified by the team were as follows: 1) the selection of the languages required for multinational trials; 2) the approaches suggested when the same language is required across two or more countries; and ...
HIV Infection and Immunosuppressive Disorders
Objective. Evaluation of the global HIV burden in Russia, identification of progress made and out... more Objective. Evaluation of the global HIV burden in Russia, identification of progress made and outstanding problems for 1987–2021.Materials and methods. The analysis of national and foreign publications, data obtained from Rosstat, from forms of federal statistical observation and the FNM of the AIDS Center of Rospotrebnadzor was carried out. The study used information-analytical, epidemiological and statistical methods. Mathematical calculations were performed using the SPSS-26 program.Results and discussion. In Russia, the target indicators of the state program of HIV/AIDS response strategy is being provided in different directions: the greatest success has been achieved in conducting chemoprevention of mother to child HIV transmission, somewhat less in the coverage of the population with HIV testing, which amounted to 26.1% versus the target indicator of 30.0% in 2021, the number of newly detected cases of HIV infection is decreasing (from 73.7 to 71.0 thousand people in 2020–2021...
Kuban Scientific Medical Bulletin, 2014
Evoked potentials technique owing to informativeness and diagnostic value is widely used in clini... more Evoked potentials technique owing to informativeness and diagnostic value is widely used in clinical and experimental studies. Herein, we investigated whether the auditory P300 event-related potentials predict syndrome vascular mild cognitive impairment. 42 patients with I and II stages of discirulatory encephalopathy (50-70 years) included in clinical study. The discriminant analysis method was used to work out an equation with two variables as predictors - the P300 latent period and patient's age. The diagnostic accuracy of the discriminant equation at a cut-off -0,268 was established through receiver operating characteristic (ROC) analysis (sensitivity 80%, specificity 74,1%).
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice
Aims. To consider factors associated with adverse outcome among hospitalized patients with modera... more Aims. To consider factors associated with adverse outcome among hospitalized patients with moderate and severe COVID-19.Materials and methods. Data from 345 case histories of adult patients hospitalized with moderate to severe COVID-19 were analyzed in a single-center retrospective study. Characteristics by sex, age, number of days from disease onset to admission to hospital, duration of hospitalization, duration of disease, population characteristics by medical history of comorbidities and self-medication, outcome of hospitalization and medical technologies used in hospital conditions were given for the whole cohort of patients. All parameters were analyzed using descriptive statistics methods. Qualitative variables are given in absolute (n) and relative (%) values with 95% confidence interval. Continuous variables were presented as median and quartiles. Risk factors for mortality were determined across groups using the χ2 criterion and odds ratio.Results. There was no demonstrate...
Real-World Data & Evidence
The growing volume and complexity of data that is currently being collected in a variety of setti... more The growing volume and complexity of data that is currently being collected in a variety of settings and devices is of varying degrees and quality, posing a challenge for the public health sector to develop a robust electronic system that can be collected, analyzed and made available to clinicians. The creation of a system, the development of the capabilities and potential of information technologies for obtaining, managing and analyzing a large amount of data, will allow to identify facts regarding the safety and effectiveness of the use of drugs, to investigate the validity of statements made by pharmaceutical companies, to obtain a more accurate characterization of treatment methods in individual healthcare sectors and to provide doctors with quick and constant access to this information, which will facilitate its use in the treatment of patients. The development of such a tool is a priority for the health care system in a changing world. An example of such a tool is the Data Ana...
General Reanimatology
The main variants of chronic consciousness disorder (CCD) developing in adverse coma outcome a... more The main variants of chronic consciousness disorder (CCD) developing in adverse coma outcome are vegetative state/unresponsive wakefulness syndrome (VS/UWS) and minimal consciousness state (MCS). The aim of the study was to investigate the main differences in metabolomic abnormalities in patients with VS / UWS and MCS, as well as to identify changes in metabolomics depending on sleep or wakefulness phase. Materials and Methods. Untargeted metabolome analysis of blood plasma of 10 patients in VS / UWS (group 1) and 6 patients in MCS (group 2) was performed using reversed-phase and hydrophilic chromatography methods. The underlying conditions of brain injury were TBI (2 in group 1 and 5 in group 2) and hypoxia (8 in group 1 and 1 in group 2). The internal jugular vein was catheterized in all patients, and blood was collected while awake during the daytime for 2 days. Aliquots of pooled plasma samples were purified from protein components and analyzed by high-performance liquid ...
The aim of the randomized controlled clinical trial was to compare the efficacy of a 3-month regi... more The aim of the randomized controlled clinical trial was to compare the efficacy of a 3-month regimen of isoniazid and pyrazinamide with that of a 6-month isoniazid in people living with HIV. Results: From the total 624 enrolled patients treatment was completed by 243 patients in short-course group and by 237 ones in IPT group (р=0,9). Adverse events were established in 6,1% of subjects in combined arm and in 6,7% in isoniazid group (р=0,8). After a follow-up 946,2 person-years, 8 person in isoniazid group and 9 person in compared group developed active TB with TB incidence per 100 person-years 1,9 and 1,8 respectively (p>0,05). The Caplan-Meyer TB survival probability for the entire group of participants over the follow up period was 0,1306 without statistical differences. Three subjects were died in isoniazid group and one person — in combined group. Conclusion. Our data may suggest that for preventing tuberculosis in HIV-infected patients, a daily 3-month regimen of isoniazid a...
International Journal of Risk & Safety in Medicine, 2015
BACKGROUND: Meta-analysis is a powerful tool to identify Evidence Based medical technologies (int... more BACKGROUND: Meta-analysis is a powerful tool to identify Evidence Based medical technologies (interventions) for use in every day practice. Meta-analysis uses statistical approaches to combine results from multiple studies in an effort to increase power (over individual studies), improve estimates of the size of the effect and/or to resolve uncertainty when reports disagree. Meta-analysis is a quantitative, formal study design used to systematically assess previous research studies to derive conclusions from this research. Meta-analysis may provide more precise estimate of the effect of treatment or risk factor for a disease, or other outcomes, than any individual study contributing to the pooled analysis. We have quite a substantial number of Russian medical publications, but not so many Meta-Analyses published in Russian. Russian publications are cited in English language papers not so often. A total of 90% of clinical studies included in published Meta-Analyses incorporate only English language papers. International studies or papers with Russian co-authors are published in English language. OBJECTIVES: The main question is: what is the problem with inclusion of Russian medical publications in Meta-Analysis? RESULTS: The main reasons for this are the following: 1) It is diffi cult to fi nd Russian papers, diffi cult to work with them and to work with Russian journals:
Value in Health, 2013
Outcomes research literature has many examples of high-quality, reliable patient-reported outcome... more Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods.
Real-World Data & Evidence
Randomized controlled trials (RCTs) are the gold standard for testing the efficacy of cancer ther... more Randomized controlled trials (RCTs) are the gold standard for testing the efficacy of cancer therapy. Although the results of clinical trials have high internal validity, their generalizability, that is, the ability to transfer the results to a wide patient population, is limited. Therefore, users and health care workers may experience less effective intervention in real practice than stated in the RCT. There are many reasons for the formation of a gap between efficacy and effectiveness (efficacyeffectiveness gap; EEG), that is, the measure of impact on RCTs and the real-world. These reasons include, for example, different characteristics of patients in the trial and real practice, compliance to treatment, features of medical care, and others. To illustrate this problem, a review of some studies on the estimation of the magnitude and analysis of the possible causes of this gap is presented. In most of the studies cited, EEG was identified, its probable explanations were proposed, an...
Success in practical rheumatology of the latest decade achieved mainly due to monoclonal antibodi... more Success in practical rheumatology of the latest decade achieved mainly due to monoclonal antibodies (MABs) appearance in routine medical practice. At the same time, the experience of practical application of MABs is limited both by observation period and exposure and their clinical and pharmacological properties do not allow to fully characterizing their safety profile with the data from clinical studies. The use of MABs is associated with the risk of delayed adverse drug reactions (ADRs) — types B (immunoallergic reactions), C (new diseases) and D (delayed teratogenic and oncogenic effects). Determination of risk factors in real medical evidence is especially important. The risk factors of ADRs including serious ADRs were studied based on an analysis of the spontaneous reports database of the Federal Service for Supervision in Healthcare and the data from rheumatologic register of patients receiving MABs — the E.E. Eikhvald Clinic in North-Western State Medical University named aft...
Arterial'naya Gipertenziya (Arterial Hypertension), Mar 12, 2018
Eksperimental'naia i klinicheskaia farmakologiia, 1997
The described dependence was formed in mice [correction of rats] by subcutaneous injections of mo... more The described dependence was formed in mice [correction of rats] by subcutaneous injections of morphine in doses growing from 10 to 100 mg/kg (8 days, twice a day). The effect of 5-HT2 receptor blocker ritanserine (1, 5, and 10 mg/kg) on expression of the abstinence syndrome (according to the behavioral and somato-autonomic parameters) 24 h after morphine discontinuation was studied. Ritanserine attenuated the manifestation of some abstinence parameters associated with activation of the serotonin system in formation of the dependence. The effect was less in expression of abstinence.
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova, 2014
Objective. Recent studies indicate that naltrexone implant may be one of the effective pharmacolo... more Objective. Recent studies indicate that naltrexone implant may be one of the effective pharmacological treatments for opiate dependence. However, nowadays many of addicts are polydrug dependent. The aim of the study was to evaluate the effectiveness of naltrexone implant in the treatment of opiate and amphetamine polydrug dependence. Material and methods. A 10-week randomized, double-blind, placebo-controlled trial with 100 patients dependent on opiates and amphetamines has been conducted. Subjects were randomized in 1:1 ratio to either naltrexone implant or identically looking placebo formulation group. Primary outcome measures were retention in the study, proportion of drug-free urine samples and improvement in the Clinical Global Impression (CGI) scale. Results. At week 10, the retention was 52% among patients with naltrexone vs. 28% among patients with placebo implant (p=0.01), and the proportion of drug-free urine samples was 38% vs. 16% (p=0.01), respectively. Fifty-six per ce...
Zhurnal vysshei nervnoi deiatelnosti imeni I P Pavlova, 1987
Eksperimental'naia i klinicheskaia farmakologiia, 1997
The effect of 5-HT2 receptor blocker ritanserine on the analgesic effect of morphine was studied ... more The effect of 5-HT2 receptor blocker ritanserine on the analgesic effect of morphine was studied in experiments on mice. A single simultaneous injection of ritanserine (10 mg/kg) and morphine (1, 10, and 20 mg/kg) prolonged the duration of analgesia in the tail clip test. Combined subchronic (6 days) injection of morphine and ritanserine (1, 5, and 10 mg/kg) twice a day delayed the development of tolerance to the opiate analgesic effect in the hot plate and tail clip tests.
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova, 2010
Two hundreds and eighty patients with heroin addiction were randomized into 4 equal groups. Patie... more Two hundreds and eighty patients with heroin addiction were randomized into 4 equal groups. Patients of the group 1 received naltrexone (N) in dosage 50 mg/day and fluoxetine (F) in dosage 20 mg/day during 6 months. Group 2 received N/F-placebo (FN), group 3--N-placebo (NP)/F and group 4--NP/FP. All patients underwent a session of individual psychotherapy for the maintenance of remission. Express urine drugs tests were used for remission control. Compliance was controlled by a riboflavin marker. Clinical state, psychiatric status and social functioning were assessed using quantified international scales and tests. To the end of the 6 month course, 43% of patients of group 1, 36% of group 2, 21% of group 3 and 10% of group 4 were in remission. Therefore, N/F was more effective than F/NP (p < 0.01) and FP/NP (p < 0.001); N/FP was more effective than F/NP (p < 0.05) and NP/FP (p < 0.001); F/NP did not differ significantly from NP/FP (p = 0.1); N/F did not differ from N/FP (...
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice, 2023
The review is focused on discussing new trends in DM, rethinking the evidence base medicine with ... more The review is focused on discussing new trends in DM, rethinking the evidence base medicine with an emphasis on demonstrating the efficacy and safety of new therapeutic agents and medical technologies, from gene editing to AI algorithms. At the same time, clinical trials of drugs are also not standing still, there is active development, new approaches, methods and designs are being developed. The process of drug development, registration and market launch of any drug takes a significant period of time, requires high financial costs and human resources. The gold standard of evidence-based medicine was initially considered to be RCTs, but at the same time, they have objective disadvantages: limited sample, inability to control all factors; insufficient follow-up time,negative impact on participants, inability to determine cause-and-effect relationships; limited measurement methods, limited budget and others. This review discusses the trends in the methodology of clinical research. The active implementation of new designs such as Adaptive Clinical Trials, "Master" protocols including Umbrella Study, Basket Study, Platform Studies, Master Observational Trials and the increased use of Single Patient Trials (N-of-1 trials) are allowing studies to become more efficient, relevant and applicable to real-life health care practice settings and patient-centered. In the review, we also look at both the pros and cons of the expanded use of biomarkers and Digital Endpoints in clinical trials and virtual clinical trials, which use mathematical models to study patient heterogeneity and its impact on various therapeutic questions. The process of expertise and regulatory approval continues to slow down the entry of drugs into the pharmaceutical market. The review considers changes in the approaches of regulators (FDA, EMEA and Russian Ministry of Health) to the drug registration procedure. The COVID-19 pandemic and sanctions have led to the need to expand the list of drugs with authorized accelerated registration. However, accelerated registration raises many questions regarding the sufficiency of the level of evidence and safety. As we can see a deep synthesis and integration of all available data is needed to achieve the next generation of evidence-based medicine. The major challenge in the next two decades will be to exploit the potential of multidimensional evidence generation by extracting, collating and generating large data sets of natural course of disease, genomics and all other omics analyses, all published clinical trials, RWD to provide next generation evidence.
Drug and Alcohol Dependence , 2017
sitivity to change. Notably, there was an average of 15 items or 9 min to complete each CAT, sign... more sitivity to change. Notably, there was an average of 15 items or 9 min to complete each CAT, significantly lower (p = 0.0002) than the original version. Conclusions: The IRT-calibrated ASI-MV CATs show promise as enhanced versions of the traditional ASI composite scores, and provide further evidence that adaptive testing based on IRT modelling could prove useful in developing highly precise measurement in the areas of addiction and mental health more broadly, as has been demonstrated in the educational field. Financial support: NIDA Grant No. R44A023322.
Профилактическая медицина, 2020
Introduction. Preclinical or clinical eating disorders may be an important risk factor for obesit... more Introduction. Preclinical or clinical eating disorders may be an important risk factor for obesity. Aim of this study-to analyze the incidence of eating disorders and their association with body mass (BM) parameters among respondents interested in BM correction. Material and methods. Data were obtained using an online survey (2013-2018), in which 27,769 respondents took part. The Eating Attitudes Test (EAT) was used to screen for eating disorders. Results. The average BM index (BMI) in men (Me=34.39 kg/m 2 , grade I-II obesity) was higher than in women (Me=30.48 kg/m 2 , p<0.01). High incidence of excess BM (29.3%), obesity grade I (27.8%) and grade II (15.5%) were registered. Grade III morbid obesity was found in 11.6% of cases. The average EAT score was 13.59±0.08 points. For men, mean values (Me=9 points) were lower than in women (Me=13 points, p<0.01). The proportion of respondents with high EAT scores (≥20) who had a high probability of eating disorders was 22.6% for respondents with excess BM, and 21.5, 21.8 and 22.7 for people with grade I, II and III obesity respectively. In total, 23% of women and 13% of men (p<0.0001) with excess BM and obesity, interested in BM correction, had eating disorders. Conclusion. The data obtained make it possible to assess the likely contribution of eating disorders to the formation of obesity with particular emphasis on a higher level of these diseases in women. Further studies of this issue may lead to the development of special preventive programs to detect and correct eating disorders among patients with excess BM and obesity.
KaÄ?estvennaâ kliniÄ?eskaâ praktika, 2018
Multinational Trials - Recommendations on the Translations Required, Approaches to Using the Same... more Multinational Trials - Recommendations on the Translations Required, Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report Abstract. Objectives: With the internationalization of clinical trial programs, there is an increased need to translate and culturally adapt patient-reported outcome (PRO) measures. Although guidelines for good practices in translation and linguistic validation are available, the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Task Force identified a number of areas where they felt that further discussion around methods and best practices would be beneficial. The areas identified by the team were as follows: 1) the selection of the languages required for multinational trials; 2) the approaches suggested when the same language is required across two or more countries; and ...
HIV Infection and Immunosuppressive Disorders
Objective. Evaluation of the global HIV burden in Russia, identification of progress made and out... more Objective. Evaluation of the global HIV burden in Russia, identification of progress made and outstanding problems for 1987–2021.Materials and methods. The analysis of national and foreign publications, data obtained from Rosstat, from forms of federal statistical observation and the FNM of the AIDS Center of Rospotrebnadzor was carried out. The study used information-analytical, epidemiological and statistical methods. Mathematical calculations were performed using the SPSS-26 program.Results and discussion. In Russia, the target indicators of the state program of HIV/AIDS response strategy is being provided in different directions: the greatest success has been achieved in conducting chemoprevention of mother to child HIV transmission, somewhat less in the coverage of the population with HIV testing, which amounted to 26.1% versus the target indicator of 30.0% in 2021, the number of newly detected cases of HIV infection is decreasing (from 73.7 to 71.0 thousand people in 2020–2021...
Kuban Scientific Medical Bulletin, 2014
Evoked potentials technique owing to informativeness and diagnostic value is widely used in clini... more Evoked potentials technique owing to informativeness and diagnostic value is widely used in clinical and experimental studies. Herein, we investigated whether the auditory P300 event-related potentials predict syndrome vascular mild cognitive impairment. 42 patients with I and II stages of discirulatory encephalopathy (50-70 years) included in clinical study. The discriminant analysis method was used to work out an equation with two variables as predictors - the P300 latent period and patient's age. The diagnostic accuracy of the discriminant equation at a cut-off -0,268 was established through receiver operating characteristic (ROC) analysis (sensitivity 80%, specificity 74,1%).
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice
Aims. To consider factors associated with adverse outcome among hospitalized patients with modera... more Aims. To consider factors associated with adverse outcome among hospitalized patients with moderate and severe COVID-19.Materials and methods. Data from 345 case histories of adult patients hospitalized with moderate to severe COVID-19 were analyzed in a single-center retrospective study. Characteristics by sex, age, number of days from disease onset to admission to hospital, duration of hospitalization, duration of disease, population characteristics by medical history of comorbidities and self-medication, outcome of hospitalization and medical technologies used in hospital conditions were given for the whole cohort of patients. All parameters were analyzed using descriptive statistics methods. Qualitative variables are given in absolute (n) and relative (%) values with 95% confidence interval. Continuous variables were presented as median and quartiles. Risk factors for mortality were determined across groups using the χ2 criterion and odds ratio.Results. There was no demonstrate...
Real-World Data & Evidence
The growing volume and complexity of data that is currently being collected in a variety of setti... more The growing volume and complexity of data that is currently being collected in a variety of settings and devices is of varying degrees and quality, posing a challenge for the public health sector to develop a robust electronic system that can be collected, analyzed and made available to clinicians. The creation of a system, the development of the capabilities and potential of information technologies for obtaining, managing and analyzing a large amount of data, will allow to identify facts regarding the safety and effectiveness of the use of drugs, to investigate the validity of statements made by pharmaceutical companies, to obtain a more accurate characterization of treatment methods in individual healthcare sectors and to provide doctors with quick and constant access to this information, which will facilitate its use in the treatment of patients. The development of such a tool is a priority for the health care system in a changing world. An example of such a tool is the Data Ana...
General Reanimatology
The main variants of chronic consciousness disorder (CCD) developing in adverse coma outcome a... more The main variants of chronic consciousness disorder (CCD) developing in adverse coma outcome are vegetative state/unresponsive wakefulness syndrome (VS/UWS) and minimal consciousness state (MCS). The aim of the study was to investigate the main differences in metabolomic abnormalities in patients with VS / UWS and MCS, as well as to identify changes in metabolomics depending on sleep or wakefulness phase. Materials and Methods. Untargeted metabolome analysis of blood plasma of 10 patients in VS / UWS (group 1) and 6 patients in MCS (group 2) was performed using reversed-phase and hydrophilic chromatography methods. The underlying conditions of brain injury were TBI (2 in group 1 and 5 in group 2) and hypoxia (8 in group 1 and 1 in group 2). The internal jugular vein was catheterized in all patients, and blood was collected while awake during the daytime for 2 days. Aliquots of pooled plasma samples were purified from protein components and analyzed by high-performance liquid ...
The aim of the randomized controlled clinical trial was to compare the efficacy of a 3-month regi... more The aim of the randomized controlled clinical trial was to compare the efficacy of a 3-month regimen of isoniazid and pyrazinamide with that of a 6-month isoniazid in people living with HIV. Results: From the total 624 enrolled patients treatment was completed by 243 patients in short-course group and by 237 ones in IPT group (р=0,9). Adverse events were established in 6,1% of subjects in combined arm and in 6,7% in isoniazid group (р=0,8). After a follow-up 946,2 person-years, 8 person in isoniazid group and 9 person in compared group developed active TB with TB incidence per 100 person-years 1,9 and 1,8 respectively (p>0,05). The Caplan-Meyer TB survival probability for the entire group of participants over the follow up period was 0,1306 without statistical differences. Three subjects were died in isoniazid group and one person — in combined group. Conclusion. Our data may suggest that for preventing tuberculosis in HIV-infected patients, a daily 3-month regimen of isoniazid a...
International Journal of Risk & Safety in Medicine, 2015
BACKGROUND: Meta-analysis is a powerful tool to identify Evidence Based medical technologies (int... more BACKGROUND: Meta-analysis is a powerful tool to identify Evidence Based medical technologies (interventions) for use in every day practice. Meta-analysis uses statistical approaches to combine results from multiple studies in an effort to increase power (over individual studies), improve estimates of the size of the effect and/or to resolve uncertainty when reports disagree. Meta-analysis is a quantitative, formal study design used to systematically assess previous research studies to derive conclusions from this research. Meta-analysis may provide more precise estimate of the effect of treatment or risk factor for a disease, or other outcomes, than any individual study contributing to the pooled analysis. We have quite a substantial number of Russian medical publications, but not so many Meta-Analyses published in Russian. Russian publications are cited in English language papers not so often. A total of 90% of clinical studies included in published Meta-Analyses incorporate only English language papers. International studies or papers with Russian co-authors are published in English language. OBJECTIVES: The main question is: what is the problem with inclusion of Russian medical publications in Meta-Analysis? RESULTS: The main reasons for this are the following: 1) It is diffi cult to fi nd Russian papers, diffi cult to work with them and to work with Russian journals:
Value in Health, 2013
Outcomes research literature has many examples of high-quality, reliable patient-reported outcome... more Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods.
Real-World Data & Evidence
Randomized controlled trials (RCTs) are the gold standard for testing the efficacy of cancer ther... more Randomized controlled trials (RCTs) are the gold standard for testing the efficacy of cancer therapy. Although the results of clinical trials have high internal validity, their generalizability, that is, the ability to transfer the results to a wide patient population, is limited. Therefore, users and health care workers may experience less effective intervention in real practice than stated in the RCT. There are many reasons for the formation of a gap between efficacy and effectiveness (efficacyeffectiveness gap; EEG), that is, the measure of impact on RCTs and the real-world. These reasons include, for example, different characteristics of patients in the trial and real practice, compliance to treatment, features of medical care, and others. To illustrate this problem, a review of some studies on the estimation of the magnitude and analysis of the possible causes of this gap is presented. In most of the studies cited, EEG was identified, its probable explanations were proposed, an...
Success in practical rheumatology of the latest decade achieved mainly due to monoclonal antibodi... more Success in practical rheumatology of the latest decade achieved mainly due to monoclonal antibodies (MABs) appearance in routine medical practice. At the same time, the experience of practical application of MABs is limited both by observation period and exposure and their clinical and pharmacological properties do not allow to fully characterizing their safety profile with the data from clinical studies. The use of MABs is associated with the risk of delayed adverse drug reactions (ADRs) — types B (immunoallergic reactions), C (new diseases) and D (delayed teratogenic and oncogenic effects). Determination of risk factors in real medical evidence is especially important. The risk factors of ADRs including serious ADRs were studied based on an analysis of the spontaneous reports database of the Federal Service for Supervision in Healthcare and the data from rheumatologic register of patients receiving MABs — the E.E. Eikhvald Clinic in North-Western State Medical University named aft...
Arterial'naya Gipertenziya (Arterial Hypertension), Mar 12, 2018
Eksperimental'naia i klinicheskaia farmakologiia, 1997
The described dependence was formed in mice [correction of rats] by subcutaneous injections of mo... more The described dependence was formed in mice [correction of rats] by subcutaneous injections of morphine in doses growing from 10 to 100 mg/kg (8 days, twice a day). The effect of 5-HT2 receptor blocker ritanserine (1, 5, and 10 mg/kg) on expression of the abstinence syndrome (according to the behavioral and somato-autonomic parameters) 24 h after morphine discontinuation was studied. Ritanserine attenuated the manifestation of some abstinence parameters associated with activation of the serotonin system in formation of the dependence. The effect was less in expression of abstinence.
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova, 2014
Objective. Recent studies indicate that naltrexone implant may be one of the effective pharmacolo... more Objective. Recent studies indicate that naltrexone implant may be one of the effective pharmacological treatments for opiate dependence. However, nowadays many of addicts are polydrug dependent. The aim of the study was to evaluate the effectiveness of naltrexone implant in the treatment of opiate and amphetamine polydrug dependence. Material and methods. A 10-week randomized, double-blind, placebo-controlled trial with 100 patients dependent on opiates and amphetamines has been conducted. Subjects were randomized in 1:1 ratio to either naltrexone implant or identically looking placebo formulation group. Primary outcome measures were retention in the study, proportion of drug-free urine samples and improvement in the Clinical Global Impression (CGI) scale. Results. At week 10, the retention was 52% among patients with naltrexone vs. 28% among patients with placebo implant (p=0.01), and the proportion of drug-free urine samples was 38% vs. 16% (p=0.01), respectively. Fifty-six per ce...
Zhurnal vysshei nervnoi deiatelnosti imeni I P Pavlova, 1987
Eksperimental'naia i klinicheskaia farmakologiia, 1997
The effect of 5-HT2 receptor blocker ritanserine on the analgesic effect of morphine was studied ... more The effect of 5-HT2 receptor blocker ritanserine on the analgesic effect of morphine was studied in experiments on mice. A single simultaneous injection of ritanserine (10 mg/kg) and morphine (1, 10, and 20 mg/kg) prolonged the duration of analgesia in the tail clip test. Combined subchronic (6 days) injection of morphine and ritanserine (1, 5, and 10 mg/kg) twice a day delayed the development of tolerance to the opiate analgesic effect in the hot plate and tail clip tests.
Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova, 2010
Two hundreds and eighty patients with heroin addiction were randomized into 4 equal groups. Patie... more Two hundreds and eighty patients with heroin addiction were randomized into 4 equal groups. Patients of the group 1 received naltrexone (N) in dosage 50 mg/day and fluoxetine (F) in dosage 20 mg/day during 6 months. Group 2 received N/F-placebo (FN), group 3--N-placebo (NP)/F and group 4--NP/FP. All patients underwent a session of individual psychotherapy for the maintenance of remission. Express urine drugs tests were used for remission control. Compliance was controlled by a riboflavin marker. Clinical state, psychiatric status and social functioning were assessed using quantified international scales and tests. To the end of the 6 month course, 43% of patients of group 1, 36% of group 2, 21% of group 3 and 10% of group 4 were in remission. Therefore, N/F was more effective than F/NP (p < 0.01) and FP/NP (p < 0.001); N/FP was more effective than F/NP (p < 0.05) and NP/FP (p < 0.001); F/NP did not differ significantly from NP/FP (p = 0.1); N/F did not differ from N/FP (...