Study of the terms for performing procedures under the HTA of a medicinal product in Bulgaria for the period 04.2016-12.2018

Introduction: The Health technology assessment (HTA) is a multidisciplinary activity that systematically assesses the effects of technology on health, on the availability and allocation of resources and their effectiveness for the health system. It is a dynamic, rapidly evolving process that helps make informed decisions about the benefits, risks and costs of introducing new technologies. The administrative terms for the HTA vary in different European countries and depend on the type of evaluation that is performed - single, multiple, rapid assessments and more. For Bulgaria, the statutory deadline for carrying out the procedure under the HTA according to Ordinance № 9 of 01.12.2015 is 90 days from the date of submission of the application by the Marketing Authorization Holder (MAH).Objective: To monitor and analyze the average duration of HTA procedures and the factors that affect it in order to assess whether the normatively determined term of 90 days is sufficient.Methodology: Monitoring, analysis and synthesis are applied for data extraction and interpretation of information about the submitted applications for HTA in National Center of Public Health and Analyses (NCPHA), as well as the overall organization of the process. Criteria for completeness and duration of the procedure are analyzed.Results: In the general case of conducting HTA, the practice shows that the normatively determined term is extremely insufficient. The leading reason for going beyond the time frame is the interval for convening and holding regular meetings of the Heath Technology Assessment Committee (HTAC). Other factors are the incomplete information in the submitted documents or the need to revise the reports. The analysis of the deadlines shows that the share of procedures completed on time is very small and decreases over the years. The longest terms are for procedures in the field of oncology, urology and hematology, and the shortest - in the field of dermatology, rheumatology and endocrinology.Conclusion: The normatively set term is insufficient and regardless of the efforts made, it was not observed in 90% of the implemented procedures. The average duration of a HTA procedure in Bulgaria in the analyzed period is about 156 days. The established practice shows that in the country the duration of HTA is close to the group of EU countries with an established term of 90-220 days

Study of High Energy Gamma-Quanta Beyond the Atmosphere

Measurements of primary cosmic radiation gamma quanta from Proton I and II satellite

Study of the nuclear component of primary cosmic rays aboard AES ''Proton-2''

Nuclear component of primary cosmic rays aboard Proton II satellite studied with aid of Cherenkov spectromete

Pharmacoeconomic analysis of medical abortion in Bulgaria

The drug treatment for interrupting early pregnancy begins with the identification of prostaglandins. In the 1970s, many developed countries legalized abortion, which led to the development and active application of this healthcare technology worldwide.The cost-effectiveness method was used in the pharmacoeconomic analysis by comparing the costs of abortion of two of the most popular protocols and dosage regimens with the medicines available at the time of the study on the Bulgarian market and the costs of classic abortion. The eventual complications were also noted. With equivalent efficiency of the two procedures, the application of cost-minimum analysis (CMA) is an appropriate and logical choice.The analysis shows that the drug termination of pregnancy under the EMA protocol is (600 mg Mifepristone + 400 mcg Misoprostol) a slightly higher cost per patient compared to the surgical abortion if the procedure is performed during the first trimester of pregnancy (∆Costs = +10,61 BGN) and leads to cost savings for the patient during the second trimester of pregnancy (∆Costs = -90,96 BGN). Medication termination of pregnancy under WHO protocol results in a cost-saving per patient compared to surgical abortion, regardless of the period of pregnancy during which the procedure is performed (∆Cost = -50,43 BGN in the first trimester and ∆Cost = -156,60 BGN in the second trimester).Drug termination is non-invasive, highly effective, and safe, resembling the natural mechanism of spontaneous abortion. In most cases, medical abortion is cost-saving and can be considered as a reasonable alternative to surgical abortion

Template design and automatic generation of controllers for industrial robots

The basic theory of supervisory control of discrete-event sys-tems is extended with the notion of templates, which sim-plifies the modeling of controllers since one can work with conceptual designs. In this work, software which provides support for the new design approach is presented along with its application to a robotic testbed

Репутационный индекс как инструмент обеспечения взаимосвязи результатов научной деятельности с бюджетным финансированием

The purpose of the paper is to develop approaches to evaluation of efficiency and effectiveness of R&D organizations with the aim of performancebased funding. Sources and methods. Based on comparative methods, the paper analyzes the Russian and international practice in efficiency and effectiveness evaluation of R&D organizations aimed at stimulating high quality of research and improving the general effectiveness of R&D budgeting in Russia. Results. The authors propose and provide rationale for approaches to identify top R&D organizations based on Research Excellence Index (REI). Methods of evaluation and financing based on the Index are described. Conclusion. Results of application of existing evaluation methods of R&D organizations in Russia cannot be efficiently used in budgetary planning procedures. At the same time, several countries (Great Britain, Australia, New Zealand, et.al.) have accumulated vast experience in evaluation of effectiveness of R&D organizations based on REI. Results of evaluations (combining both qualitative methods and experts’ opinions) are successfully used in distribution of research grants among academic institutions. Application of REI in Russia will allow to provide additional financing to top R&D organizations without necessity to increase the general amount of the national R&D budget. Цель работы – формирование научно обоснованных предложений по совершенствованию подходов к оценке результативности и эффективности деятельности научных организаций, осуществляющих научно-исследовательские и опытно-конструкторские разработки (НИОКР), и предложений по обеспечению взаимосвязи результатов научной деятельности с бюджетным финансированием. Материалы и методы. В статье на основе методов сравнения и аналогии проведен анализ российской и международной практики оценки результативности и эффективности деятельности научных организаций в целях стимулирования повышения качества исследований и совершенствования бюджетного планирования расходов на науку в России. Результаты. Авторы предлагают подходы к выделению научных организаций, обладающих повышенной компетенцией в своей сфере деятельности, на основе индекса научной репутации (репутационного индекса) научных организаций. В статье предлагаются и обосновываются подходы к оценке и финансированию научных организаций с наивысшими значениями репутационного индекса. Выводы. Существующие в настоящее время в России подходы к оценке научных организаций не могут эффективно использоваться при бюджетном планировании расходов на науку. В ряде стран накоплен опыт применения методов оценки научных организаций на основе использования репутационного индекса, который отражает уровень научных исследований в конкретных учреждениях и определяется на основе количественных показателей результатов и/или экспертного суждения. Опыт ряда стран, прежде всего, Великобритании, Австралии и Новой Зеландии, свидетельствует об успешности применения репутационного индекса при распределении грантов образовательным учреждениям в целях стимулирования высокого качества научной деятельности. Применение репутационного индекса в России позволит обеспечить финансовое стимулирование передовых научных организаций в рамках выполнения государственного задания без изменения общего объема бюджетного финансирования научной деятельности.

Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA

BACKGROUND: The initial presentation of sepsis in the emergency department (ED) is difficult to distinguish from other acute illnesses based upon similar clinical presentations. A new blood parameter, a measurement of increased monocyte volume distribution width (MDW), may be used in combination with other clinical parameters to improve early sepsis detection. We sought to determine if MDW, when combined with other available clinical parameters at the time of ED presentation, improves the early detection of sepsis. METHODS: A retrospective analysis of prospectively collected clinical data available during the initial ED encounter of 2158 adult patients who were enrolled from emergency departments of three major academic centers, of which 385 fulfilled Sepsis-2 criteria, and 243 fulfilled Sepsis-3 criteria within 12 h of admission. Sepsis probabilities were determined based on MDW values, alone or in combination with components of systemic inflammatory response syndrome (SIRS) or quick sepsis-related organ failure assessment (qSOFA) score obtained during the initial patient presentation (i.e., within 2 h of ED admission). RESULTS: Abnormal MDW (\u3e 20.0) consistently increased sepsis probability, and normal MDW consistently reduced sepsis probability when used in combination with SIRS criteria (tachycardia, tachypnea, abnormal white blood count, or body temperature) or qSOFA criteria (tachypnea, altered mental status, but not hypotension). Overall, and regardless of other SIRS or qSOFA variables, MDW \u3e 20.0 (vs. MDW ≤ 20.0) at the time of the initial ED encounter was associated with an approximately 6-fold increase in the odds of Sepsis-2, and an approximately 4-fold increase in the odds of Sepsis-3. CONCLUSIONS: MDW improves the early detection of sepsis during the initial ED encounter and is complementary to SIRS and qSOFA parameters that are currently used for this purpose. This study supports the incorporation of MDW with other readily available clinical parameters during the initial ED encounter for the early detection of sepsis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03145428. First posted May 9, 2017. The first subjects were enrolled June 19, 2017, and the study completion date was January 26, 2018

PARTIAL PORTOSYSTEMIC SHUNTING BY CARBON-COATED ePTFE GRAFTS FOR PORTAL HYPERTENSION IN CIRRHOTIC PATIENTS

We present our first experience gained in use of polytetrafluoroethylene carbon-coated grafts for partial portosystemic shunting in three cirrhotic patients. The results obtained indicate that these grafts in mesocaval position can function as a long-term «bridge» to hepatic transplantation in patients with uncontrolled gastroesophageal varices. The different options of portal hypertension treatment and the current role of shunting procedures in the era of liver transplantation are discussed in short literature review

Solution combustion synthesis of α-Al2O3 using urea

The processes involved in the solution combustion synthesis of α-Al2O3 using urea as an organic fuel were investigated. The data describing the influence of the relative urea content on the characteristic features of the combustion process, the crystalline structure and the morphology of the aluminium oxide are presented herein. Our data demonstrate that the combustion of stable aluminium nitrate and urea complexes leads to the formation of α-alumina at temperatures of approximately 600-800 °C. Our results, obtained using differential thermal analysis and IR spectroscopy methods, reveal that the low-temperature formation of α-alumina is associated with the thermal decomposition of an α-AlO(OH) intermediate, which was crystallised in the crystal structure of the diaspore. © 2012 Elsevier Ltd and Techna Group S.r.l