PROFESSIONAL SELF-DETERMINATION OF GRADUATES OF HIGHER EDUCATIONAL INSTITUTIONS OF THE SVERDLOVSK REGION

In these thesis the results of a sociological survey conducted at the end of 2016 are analyzed. The aim is to identify the actual problems of efficiency in the field of interaction between universities and enterprises of the Sverdlovsk region, which are training young specialists process demanded in the labor market. The main factors determining professional self-determination of graduates are described

EXPERIENCE OF INTRODUCING IN THE URFU THE PROCEDURES OF ELECTRONIC INTERNAL AUDITS

To clarify the possibility of increasing effectiveness of internal audits, the thesis analyzes existing approaches to this procedure. The main causes of this problem are indicated. The results of the analysis formed the basis for the proposed procedure for automated processing of the results of electronic internal audits, which allows one to objectively and timely to create a protocol for analyzing QMS functioning by senior management, and to identify bottlenecks in the functioning of QMS with a view to their subsequent elimination

Development and Implementation of Electronic Internal Audit Procedures at the University

In order to find out if it is possible to improve efficacy of conducting internal audits, the article analyzes existing approaches to this procedure. It proves that modern information technologies are not sufficiently used to increase efficacy. The main reasons behind this problem are indicated. The results of the analysis form the basis for the suggested procedure of automated electronic internal audit results processing. This procedure provides objective and timely formation of important document on the state of QMS – «Protocol of QMS functioning analysis by executives» and to identify «narrow points» in QMS functioning with the aim of their further elimination. This question is important due to the growth of information scope, of the list of tasks arising from the constant increase of departments involved into the audit, and of the list of standards checked according to the requirements of State Standard RV 0015–002–2012 QMS – System of Developing and Implementing the Product. The variant suggested for conducting electronic internal audit makes it possible to decrease the amount of result processing; to increase the number of processing parameters; to increase their efficacy; and to decrease the number of technical mistakes in forming data for managerial decision making. It can be used by different university structures involved into conducting internal audits for created management systems: the system of social responsibility management, power management system. Suggested methods for conducting internal audits for fulfilling the requirements of regulating documents (management systems standards) can be applied for other large – scale inspections requiring the control over multiple legislative requirements. The procedure has an opportunity for operational processing of obtained data and automatic formation of necessary data into reports according to legislative requirements.Для выяснения возможности повышения эффективности проведения внутренних аудитов в статье проведен анализ существующих подходов к этой процедуре. Он подтвердил, что современные информационные технологии для повышения эффективности используются в недостаточной мере. Указаны основные причины данной проблемы. Результаты анализа легли в основу предлагаемой процедуры автоматизированной обработки результатов проведения электронных внутренних аудитов. Данная процедура позволяет объективно и своевременно обеспечить формирование значимого и важного документа о состоянии СМК – «Протокола анализа функционирования СМК со стороны высшего руководства», а также выявлять «узкие места» в функционировании СМК с целью их последующего устранения. Важность этого вопроса обусловлена ростом объема информации и перечня задач, которые связаны с постоянным увеличением числа вовлекаемых в аудит подразделений и перечня проверяемых требований стандарта ГОСТ РВ 0015–002–2012 СМК «Система разработки и постановки продукции на производство». Предлагаемый вариант проведения электронных внутренних аудитов позволяет сократить время обработки результатов проведения электронных внутренних аудитов; увеличить количество параметров обработки; повысить оперативность и сократить число технических ошибок при формировании данных для принятия управленческих решений. Она может быть использована различными подразделениями университета, которые вовлекаются в проведение внутренних аудитов по создаваемым системам менеджмента: системе менеджмента социальной ответственности, системе энергоменеджмента. Предлагаемая методика проведения внутренних аудитов (проверок) выполнения требований нормативных документов (стандартов на системы менеджмента) может быть применена и для иных масштабных проверок, в которых необходимо осуществлять контроль выполнения множества нормативных требований. В процедуре имеется возможность оперативной обработки полученных данных и автоматического формирования необходимых данных в отчеты в соответствии с требованиями нормативных документов

Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial

Background: We aimed to assess efficacy and safety, with a special focus on cardiovascular safety, of the novel dual GIP and GLP-1 receptor agonist tirzepatide versus insulin glargine in adults with type 2 diabetes and high cardiovascular risk inadequately controlled on oral glucose-lowering medications. Methods: This open-label, parallel-group, phase 3 study was done in 187 sites in 14 countries on five continents. Eligible participants, aged 18 years or older, had type 2 diabetes treated with any combination of metformin, sulfonylurea, or sodium-glucose co-transporter-2 inhibitor, a baseline glycated haemoglobin (HbA1c) of 7·5–10·5% (58–91 mmol/mol), body-mass index of 25 kg/m2 or greater, and established cardiovascular disease or a high risk of cardiovascular events. Participants were randomly assigned (1:1:1:3) via an interactive web-response system to subcutaneous injection of either once-per-week tirzepatide (5 mg, 10 mg, or 15 mg) or glargine (100 U/mL), titrated to reach fasting blood glucose of less than 100 mg/dL. The primary endpoint was non-inferiority (0·3% non-inferiority boundary) of tirzepatide 10 mg or 15 mg, or both, versus glargine in HbA1c change from baseline to 52 weeks. All participants were treated for at least 52 weeks, with treatment continued for a maximum of 104 weeks or until study completion to collect and adjudicate major adverse cardiovascular events (MACE). Safety measures were assessed over the full study period. This study was registered with ClinicalTrials.gov, NCT03730662. Findings: Patients were recruited between Nov 20, 2018, and Dec 30, 2019. 3045 participants were screened, with 2002 participants randomly assigned to tirzepatide or glargine. 1995 received at least one dose of tirzepatide 5 mg (n=329, 17%), 10 mg (n=328, 16%), or 15 mg (n=338, 17%), or glargine (n=1000, 50%), and were included in the modified intention-to-treat population. At 52 weeks, mean HbA1c changes with tirzepatide were −2·43% (SD 0·05) with 10 mg and −2·58% (0·05) with 15 mg, versus −1·44% (0·03) with glargine. The estimated treatment difference versus glargine was −0·99% (multiplicity adjusted 97·5% CI −1·13 to −0·86) for tirzepatide 10 mg and −1·14% (−1·28 to −1·00) for 15 mg, and the non-inferiority margin of 0·3% was met for both doses. Nausea (12–23%), diarrhoea (13–22%), decreased appetite (9–11%), and vomiting (5–9%) were more frequent with tirzepatide than glargine (nausea 2%, diarrhoea 4%, decreased appetite <1%, and vomiting 2%, respectively); most cases were mild to moderate and occurred during the dose-escalation phase. The percentage of participants with hypoglycaemia (glucose <54 mg/dL or severe) was lower with tirzepatide (6–9%) versus glargine (19%), particularly in participants not on sulfonylureas (tirzepatide 1–3% vs glargine 16%). Adjudicated MACE-4 events (cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina) occurred in 109 participants and were not increased on tirzepatide compared with glargine (hazard ratio 0·74, 95% CI 0·51–1·08). 60 deaths (n=25 [3%] tirzepatide; n=35 [4%] glargine) occurred during the study. Interpretation: In people with type 2 diabetes and elevated cardiovascular risk, tirzepatide, compared with glargine, demonstrated greater and clinically meaningful HbA1c reduction with a lower incidence of hypoglycaemia at week 52. Tirzepatide treatment was not associated with excess cardiovascular risk. Funding: Eli Lilly and Company

Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients

BACKGROUN

Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients

Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin- kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death; 93% of the patients were receiving statin therapy at baseline. The trials were stopped early after the sponsor elected to discontinue the development of bococizumab owing in part to the development of high rates of antidrug antibodies, as seen in data from other studies in the program. The median follow-up was 10 months. RESULTS At 14 weeks, patients in the combined trials had a mean change from baseline in LDL cholesterol levels of -56.0% in the bococizumab group and +2.9% in the placebo group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001). In the lower-risk, shorter-duration trial (in which the patients had a baseline LDL cholesterol level of ≥70 mg per deciliter [1.8 mmol per liter] and the median follow-up was 7 months), major cardiovascular events occurred in 173 patients each in the bococizumab group and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], 0.80 to 1.22; P = 0.94). In the higher-risk, longer-duration trial (in which the patients had a baseline LDL cholesterol level of ≥100 mg per deciliter [2.6 mmol per liter] and the median follow-up was 12 months), major cardiovascular events occurred in 179 and 224 patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P = 0.02). The hazard ratio for the primary end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P = 0.08). Injection-site reactions were more common in the bococizumab group than in the placebo group (10.4% vs. 1.3%, P<0.001). CONCLUSIONS In two randomized trials comparing the PCSK9 inhibitor bococizumab with placebo, bococizumab had no benefit with respect to major adverse cardiovascular events in the trial involving lower-risk patients but did have a significant benefit in the trial involving higher-risk patients