Safety Variables Research Articles

Tall Fescue Mowing Height Effects under Simulated Athletic Field Traffic

Tall fescue (Schedonorus arundinaceus) offers an alternative to kentucky bluegrass (Poa pratensis) for use on athletic fields. Tall fescue has the ability to withstand athletic field traffic, but little is known about the best management practices such as optimal height of cut (HOC). A 2-year study was conducted on established ‘Snap Back’ tall fescue grown over a native soil root zone to determine optimal HOC under simulated athletic field traffic. Plots were maintained at various HOC treatments (1.5, 2, or 3 inches) for the duration of the growing season. Twenty-five simulated traffic events were applied each fall with a modified Baldree traffic simulator. The percentage of green cover (GC) loss per traffic event by HOC varied between years. In 2017, the 1.5-inch HOC improved traffic tolerance (–1.7% GC per event) compared with the other HOC treatments (–2.6% GC per event) in terms of percentage of GC. In 2018, the HOC did not have an impact on traffic tolerance. Differences in traffic tolerance between years could be a result of differences in precipitation (78 mm in 2017, 6 mm in 2018) during the period when traffic occurred, which suggest that the lower HOC performs better under wet conditions compared with the greater HOC. There were no differences among treatments for the safety variables measured (surface hardness, rotational resistance, and soil moisture).

System Safety Assessment of the Warehouse Operation Using Functional Resonance Analysis Method and Resilience Analysis Grid

This study applied the perspective of Safety-II using the Functional Resonance Analysis Method (FRAM) and the Resilience Analysis Grid (RAG) to analyze safety in warehouse operations from a system perspective. FRAM was used to emphasize what caused things to go right, with the findings highlighting higher performance and safety variability occurring in activities that require multiple individual or group efforts. RAG was used to assess the organization’s potential to handle unexpected occurrences, identify the potential resilience of the warehouse in its daily activities, and evaluate the ability to maintain flow and worker safety based on four pillars of resilience. The assessment resulted in a value of 3.50 in the ability to respond, 2.84 in the ability to monitor, 3.88 in the ability to learn, and 3.21 in the ability to anticipate. Combining FRAM and RAG enhances the depth of a new perspective of safety analysis and addresses resilience factors in daily operations.

Prevalence and Impact of Medical Complications on Clinical Outcomes in Acute Ischemic Stroke Patients After Endovascular Therapy – Data From a Comprehensive Stroke Unit in China

ObjectiveWe aim to assess the incidence and impact of in-hospital medical complications (MCs) on clinical outcomes in acute ischemic stroke (AIS) patients after endovascular therapy (EVT). MethodsAIS patients who underwent EVT were consecutively recruited from January 2019 to July 2022. The primary outcome was a poor 3-month functional outcome, defined as a modified Rankin Scale score (mRS) of 3-6. The safety variables were symptomatic intracerebral hemorrhage (sICH) and mortality at seven and 30 days. ResultsA total of 306 (50.1%) patients experienced at least one of the MCs. The most common MC was pneumonia (42.6%). Multivariate analysis revealed that the setting of MCs was an independent predictor of a poor 3-month functional outcome (adjusted odds ratio [aOR] 4.40, 95% confidence interval [CI] 3.01-6.42; P<0.001). In the subgroup analysis, this trend was significant, especially in the patients aged 60 to75 years (aOR 5.87, 95% CI 3.45-9.97; P<0.001) or with baseline NIHSS (≤16) (aOR 5.05, 95% CI 2.84-9.01; P<0.001). For individuals, cardiac events (aOR 8.56, 95% CI 4.05-18.09; P<0.001), pneumonia (aOR 5.08, 95%CI 3.42-7.55; P<0.001), and gastrointestinal bleeding (GIB) (aOR 6.12, 95%CI 3.40-11.01; P<0.001) were independently associated with the poor 3-month outcome. The setting of MCs was independently associated with sICH (aOR 2.11, 95% CI 1.22-3.64; P=0.007) and mortality at 30 days (aOR 2.11, 95% CI 1.22-3.64; P=0.007) after adjustment, but not with mortality at seven days. ConclusionsMCs in AIS patients after EVT have a high incidence, despite successful reperfusion, adversely affecting clinical outcomes and increasing short-term mortality.

Pengaruh Penggunaan Fitur Shopee Pay Terhadap Perilaku Konsumsi Islam

This study aims to determine the effect of using the shopeepay feature on Islamic consumption behavior in the people of Gorontalo. Exogenous variables in this study, namely convenience, safety, and lifestyle and endogenous variables, namely, Islamic consumption behavior. The research method used is quantitative with multiple linear regression analysis data using EViews 12 Software. The results show that the convenience of the shopeepay feature has a positive and significant effect on Islamic consumption behavior, the safety of the shopeepay feature does not have a significant effect on Islamic consumption behavior, lifestyle has a significant effect on consumption behavior Islam.

Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial

Aims/hypothesisEarly time-restricted carbohydrate consumption (eTRC) is a novel dietary strategy that involves restricting carbohydrate-rich food intake to the morning and early afternoon to align with circadian variations in glucose tolerance. We examined the efficacy, feasibility and safety of eTRC in individuals with type 2 diabetes under free-living conditions.MethodsIn this randomised, parallel-arm, open label, controlled trial, participants with type 2 diabetes and overweight/obesity (age 67.2±7.9 years, 47.8% women, BMI 29.4±3.7 kg/m2, HbA1c 49±5 mmol/mol [6.6±0.5%]) were randomised, using computer-generated random numbers, to a 12 week eTRC diet or a Mediterranean-style control diet with matched energy restriction and macronutrient distribution (50% carbohydrate, 30% fat and 20% protein). The primary outcome was the between-group difference in HbA1c at 12 weeks. Body composition, 14 day flash glucose monitoring and food diary analysis were performed every 4 weeks. Mixed meal tolerance tests with mathematical beta cell function modelling were performed at baseline and after 12 weeks.ResultsTwelve (85.7%) participants in the eTRC arm and 11 (84.6%) participants in the control arm completed the study, achieving similar reductions in body weight and fat mass. The two groups experienced comparable improvements in HbA1c (−3 [−6, −0.3] mmol/mol vs −4 [−6, −2] mmol/mol, corresponding to −0.2 [−0.5, 0]% and −0.3 [−0.5, −0.1]%, respectively, p=0.386), fasting plasma glucose, flash glucose monitoring-derived glucose variability and mixed meal tolerance test-derived glucose tolerance, insulin resistance, insulin clearance and plasma glucagon levels, without changes in model-derived beta cell function parameters, glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide and non-esterified fatty acid levels. The two diets similarly reduced liver function markers and triglyceride levels, being neutral on other cardiometabolic and safety variables. In exploratory analyses, diet-induced changes in body weight and glucometabolic variables were not related to the timing of carbohydrate intake.Conclusions/interpretationThe proposed eTRC diet provides a feasible and effective alternative option for glucose and body weight management in individuals with type 2 diabetes, with no additional metabolic benefits compared with conventional dieting.Trial registrationClinicalTrials.gov NCT05713058FundingThis study was supported by the European Society for Clinical Nutrition and Metabolism (ESPEN) and the Italian Society of Diabetology (SID).Graphical

Population pharmacokinetic/pharmacodynamic modeling and exposure-response analysis of ciprofol in the induction and maintenance of general anesthesia in patients undergoing elective surgery: A prospective dose optimization study

AimThis study aimed to establish a population pharmacokinetic and pharmacodynamic (PK-PD) model to explore the optimal maintenance dose and appropriate starting time of maintenance dose after induction of ciprofol and investigate the efficacy and safety of ciprofol for general anesthesia induction and maintenance in patients undergoing elective surgery. MethodA total of 334 subjects with 3092 concentration measurements from nine clinical trials and 115 subjects with 5640 bispectral index (BIS) measurements from two clinical trials were used in the population PK-PD analysis. Exposure-response relationships for both efficacy endpoints (duration of anesthesia successful induction, time to recovery from anesthesia, time to respiratory recovery, and time from discontinuation to the 1st/3rd consecutive Aldrete score ≥ 9) and safety variables (hypotension, bradycardia, and injection site pain) were evaluated based on the data gathered from 115 subjects in two clinical trials. ResultCiprofol pharmacokinetics (PK) were adequately described by a three-compartment model with first-order elimination from the central compartment and redistribution from the deep and shallow peripheral compartments. An inhibitory sigmoidal Emax model best described the relationship between ciprofol effect-site concentrations and BIS measurements. Body weight, age, sex, blood sampling site, and study type (short-term infusion vs long-term infusion) were identified as statistically significant covariates on the PK of ciprofol. No covariates were found to have a significant effect on the pharmacodynamic (PD) parameters. The PK-PD simulation results showed that the optimal maintenance dose was 0.8 mg/kg/h and the appropriate time to start the maintenance dose was 4–5 mins after the induction dose of ciprofol. Within the exposure range of this study, no meaningful correlations between ciprofol exposures and efficacy or safety endpoints were observed. ConclusionA population PK-PD model was successfully developed to describe the ciprofol PK and BIS changes. Efficacy was consistent across the exposure range with a well-tolerated safety profile indicating no maintenance dose adjustment is required for patients undergoing elective surgery.

Pengaruh Kesehatan Dan Keselamatan Kerja (K3) Dan Jenjang Karir Terhadap Kepuasan Kerja Karyawan Pada PT. PLN (PERSERO) Ulp Bintuhan

The purpose of this study were: to determine the effect of occupational safety and health (K3) on employee job satisfaction at PT. PLN (Persero) ULP Bintuhan; to determine the effect of career level on employee job satisfaction at PT. PLN (Persero) ULP Bintuhan and to determine the effect of occupational safety and health (K3) and career level on employee job satisfaction at PT. PLN (Persero) ULP Bintuhan. The analytical method used is validity test, reliability test, simple linear regression, coefficient of determination, F test and t test.Based on the research results indicate that occupational safety and health or K3 (X1) partially has a significant effect on job satisfaction of employees of PT. PLN (Persero) ULP Bintuhan (Y) because the significant value is 0.000 &lt; 0.05. Career level (X2) partially has a significant effect on job satisfaction of employees of PT. PLN (Persero) ULP Bintuhan (Y) because the significant value is 0.000 &lt; 0.05. Occupational safety and health variables or K3 (X1), career level (X2) simultaneously or together have a significant effect on employee job satisfaction (Y) at PT. PLN (Persero) ULP Bintuhan because the significant value is 0.000 &lt; 0.05

Level of road user satisfaction with safety and confort on jalan Mohammad hatta

Mohammad Hatta Road is a type of district road that is used as a link between Kurik District and MalindiMalindiMalindi District. The increased activity and mobility of residents on Jalan Mohammad Hatta have not been balanced with safety and comfort for road users, such as damage to the road body and a lack of supporting facilities on the road. The purpose of this study was to determine the factors that influence the lack of safety and comfort levels of road users and the influence between satisfaction variables on safety and comfort variables on Jalan Mohammad Hatta. This research method uses the correlation test method. This test is used to find the relationship between variable X (satisfaction) and variable Y (safety and comfort) on Jalan Mohammad Hatta which has bad road conditions. The data used in this study were obtained by distributing questionnaires with a total sample of 394 respondents. The results of this study showed that people were dissatisfied a percentage of 83.61%, insecure with a percentage of 83.92%, and very uncomfortable with percentage of 84.01%, in terms of several factors, namely road conditions, stability of vehicles, health, travel effectiveness, economy, pavement structure, socio-cultural conditions, facilities, and accessibility. There is a relationship between the satisfaction variable and the safety variable with a correlation value of 0.905 and a relationship between the satisfaction variable and the comfort variable with a correlation value of 0.886. So it shows that the higher the level of safety and comfort, the higher the level of satisfaction of road users.

PENGARUH KESELAMATAN DAN KESEHATAN KERJA TERHADAP KINERJA KARYAWAN PADA PT. BESMINDO MATERI SEWATAMA DURI-RIAU

The purpose of this study was to determine the effect of Occupational Safety and Health on Employee Performance at PT. Besmindo Materials Sewatama Duri-Riau. Data collection was carried out by distributing questionnaires which were given to 81 floorman employees. Data analysis in this study used the SPSS Version 22 application. The results of this assessment indicate that the Occupational Safety and Health variables simultaneously have a positive and significant effect on Employee Performance at PT. Besmindo Materials Sewatama Duri-Riau. While partially shows that “Work Safety has a positive and significant effect on Employee Performance at PT. Besmindo Material Sewatama Duri-Riau with a multiple regression coefficient value of 0.426 and a significant value of 0.001 &lt;0.05 (smaller than the error tolerance value). Occupational Health has a positive and significant effect on Employee Performance at PT. Besmindo Materials Sewatama Duri-Riau with a regression coefficient of 0.452 and a significant value of 0.007&lt;0.05 (smaller than the error value). From the results of the research and also the discussion conducted, PT. Besmindo Materials Sewatama Duri-Riau to further develop and pay attention to the indicators contained in Occupational Safety and Occupational Health on Employee Performance at PT. Besmindo Materials Sewatama Duri-Riau.

Analisis Pengaruh Kedisiplinan Kerja, Keselamatan dan Kesehatan Kerja (K3), Serta Lingkungan Kerja Terhadap Kinerja Karyawan PT. BBIC BERCA CABLES di Kabupaten Tangerang

PT. BIIC Berca Cables is a company that produces electrical cables and fiber optic cables. Supervising employee discipline, safety &amp; health and the work environment is a way to maintain or improve employee performance. In the preliminary survey conducted, it showed that employee performance was considered to have not met the company's expectations, where many failures were still found during the Optic Cable Quality Test process. The aim of this research is to partially analyze (1) the influence of work discipline variables, (2) occupational safety and health (OSH), and (3) the work environment on employee performance and simultaneously analyze the influence of work discipline, occupational safety and occupational health (OSH) as well as the work environment on employee performance. The research design is associative quantitative, which is a depiction of the relationship between one variable and another. Researchers distributed questionnaires to employees as a method of data collection techniques. The analysis technique used is Correlation Test, Multiple Linear Regression Analysis. In the classical assumption test there is a normality test, multicollinearity test and heteroscedasticity test. From the research results it can be concluded that partially the work discipline variable has a significant positive effect on employee performance, the occupational safety and health (OSH) variable has a significant positive effect, and the work environment variable has a significant positive effect. Simultaneously, work discipline variables, occupational safety and health (K3) variables, and work environment variables have a positive and significant effect on the performance of PT employees. BIIC Berca Cables in Tangerang Regency.&#x0D; Keywords : Discipline, Safety, Health, Environment, Employee Performance

아시아 국가들의 주관적 건강상태에 미치는 영향요인 분석

This study utilized self-rated health as a method of reducing the deviation between health index and actual health level in Asia. Using the Human Development Index (HDI) score of the United Nations Development Program (UNDP), countries were grouped into countries with relatively high health (Group A), middle-level countries (Group B), and countries with relatively low levels of health (Group C), Factors affecting subjective health status for each group with similar health levels were analyzed using the logit model. As an independent variable, psychological, political, economic, social, and environmental factors affecting subjective health were derived using World Values Survey (WVS) data, and the dependent variable was subjective health status. Spatial coverage includes Asian countries, including three Northeast Asian countries, China, Japan, and South Korea, and Southeast Asian countries, Bangladesh, Indonesia, Malaysia, Myanmar, Pakistan, Philippines, Thailand, and Vietnam within the scope of the data. The temporal range corresponds to WVS data Wave 7 from 2017 to 2019. As a result of logistic regression analysis, the variables common to the three groups were life satisfaction and happiness among psychological factors, financial condition satisfaction among economic factors, trust in neighbors among social factors, and medical condition among environmental factors. Group A, which has a relatively high level of health, needs to maintain the psychological and economic factors that have an overall influence, and trust in government, trust in neighbors, group activities, and competition, which are relatively low compared to groups B and C. This suggests that it is necessary to prepare policies to improve awareness and satisfaction with life safety variables. Group B, which has a moderate health index, has to deal with health policies in the direction of maintaining the relatively high level of political and social factors compared to groups A and C. Group C, which has a relatively low health index, has an overall impact. There is a need to improve health policies focusing on psychological and environmental factors that are affecting people's health.

Analysis Of Seaport Safety In Nigeria: Case Of Apapa Port Complex Lagos

The aim of this study is to assess the seaport operational safety of Apapa port Lagos. Primary data were collected using survey for the analysis. The study utilized Logit model and Multi-Criteria Decision Analysis to analyse the data collected from` the seaport. In running the analysis, SPSS software version 24.0 was used to analyse the data. The result from the Logit model shows that there is a high significant relationship between the dependent and independent variables tested in the study. This means that there is need for improvement in the area of safety at the port. Furthermore, the multi-criteria decision analysis result also shows various sections and their corresponding weights and ranks with a level of improvement that will be help to step up or enhance the safety variables during port operation. The study recommends that the seaport should be carrying out constant safety study from time to time to increase the safety and security levels of the seaport as recommended by the IMO

Learning from experience: Integrating patient experience survey responses with other key metrics to understand and improve care quality and patient safety

Abstract Issue The Irish National Care Experience Programme (NCEP) collects rich qualitative and quantitative data on patient and service-user experiences of healthcare. These survey data are not routinely triangulated with other quality and safety datasets for patient safety surveillance. Description of the problem The Irish Health Service Executive has commenced development of a quality and patient safety surveillance system called Quality and Safety Signals (QS Signals). This programme seeks to optimise the use of existing data to reduce variability in quality and safety of services, identify risks and signals of concern, as well as learnings from signals of excellence. Patient experience data is a rich source of insight into quality and safety of care but currently, it is not routinely considered alongside other quality and safety measures. Results As a proof of concept, the Quality and Safety Signals programme is collaborating with the National Women and Infants Health Programme (NWIHP) to develop a composite profile of quality and safety for maternity and neonatal services. A Clinical Advisory Group (CAG) has been established with multi-disciplinary clinical representation from Ireland's six Maternity Networks. To reach agreement amongst the CAG on the indicators relevant to the measurement of quality and safety, a series of interviews, workshops and a Delphi Survey are being conducted. The co-design process seeks consensus on the themes and classification structure appropriate for a composite profile of quality and safety. Lessons The implementation of a patient safety surveillance system challenges the Irish health system to reflect on how available data can best be harnessed. Person-centredness is a core domain of healthcare quality. Capturing the person's experience of care through the NCEP surveys is vital to ensuring the development of a comprehensive profile and guiding quality improvements.

Head-to-head comparison of azvudine and nirmatrelvir/ritonavir for the hospitalized patients with COVID-19: a real-world retrospective cohort study with propensity score matching.

Background: Nirmatrelvir/ritonavir and azvudine have been approved for the early treatment of COVID-19 in China, however, limited real-world data exists regarding their effectiveness and safety. Methods: We conducted a retrospective cohort study involving the hospitalized COVID-19 patients in China between December 2022 and January 2023. Demographic, clinical, and safety variables were recorded. Results: Among the 6,616 hospitalized COVID-19 patients, we included a total of 725 patients including azvudine recipients (N = 461) and nirmatrelvir/ritonavir (N = 264) recipients after exclusions and propensity score matching (1:2). There was no significant difference in the composite disease progression events between azvudine (98, 21.26%) and nirmatrelvir/ritonavir (72, 27.27%) groups (p = 0.066). Azvudine was associated with a significant reduction in secondary outcomes, including the percentage of intensive care unit admission (p = 0.038) and the need for invasive mechanical ventilation (p = 0.035), while the in-hospital death event did not significantly differ (p = 0.991). As for safety outcomes, 33 out of 461 patients (7.16%) in azvudine group and 22 out of 264 patients (8.33%) in nirmatrelvir/ritonavir group experienced drug-related adverse events between the day of admission (p = 0.565). Conclusion: In our real-world setting, azvudine treatment demonstrated similar safety compared to nirmatrelvir/ritonavir in hospitalized COVID-19 patients. Additionally, it showed slightly better clinical benefits in this population. However, further confirmation through additional clinical trials is necessary.

Adult Severe Asthma Registries: A Global and Growing Inventory.

The International Severe Asthma Registry (ISAR; http://isaregistries.org/) uses standardised variables to enable multi-country and adequately powered research in severe asthma. This study aims to look at the data countries within ISAR and non-ISAR countries reported collecting that enable global research that support individual country interests. Registries were identified by online searches and approaching severe asthma experts. Participating registries provided data collection specifications or confirmed variables collected. Core variables (results from ISAR's Delphi study), steroid-related comorbidity variables, biologic safety variables (serious infection, anaphylaxis, and cancer), COVID-19 variables and additional variables (not belonging to the aforementioned categories) that registries reported collecting were summarised. Of the 37 registries identified, 26 were ISAR affiliates and 11 non-ISAR affiliates. Twenty-five ISAR-registries and 4 non-ISAR registries reported collecting >90% of the 65 core variables. Twenty-three registries reported collecting all optional steroid-related comorbidity variables. Twenty-nine registries reported collecting all optional safety variables. Ten registries reported collecting COVID-19 variables. Twenty-four registries reported collecting additional variables including data from asthma questionnaires (10 Asthma Control Questionnaire, 20 Asthma Control Test, 11 Asthma Quality of Life Questionnaire, and 4 EuroQol 5-dimension 5-level Questionnaire). Eight registries are linked to databases such as electronic medical records and national claims or disease databases. Standardised data collection has enabled individual severe asthma registries to collect unified data and increase statistical power for severe asthma research irrespective of ISAR affiliations.

Pengaruh Keselamatan dan Kesehatan Kerja dan Kepuasan Kerja terhadap Kinerja Karyawan PT Bahari Internasional Mandiri Medan

This aim is to find out the Effect of Occupational Safety and Health and Job Satisfaction on Employee Performance at PT Bahari Internasional Mandiri Medan. The sampling technique used is the total sampling method because the population in this company is 51 people. The analysis technique used is descriptive method and quantitative method. The results of this study indicate that the variable occupational safety and health (X1) has a positive and significant effect on the performance of employees of PT. Bahari Internasional Mandiri Medan Job satisfaction variable (X2) has a positive and significant effect on the performance of employees of PT. Bahari Internasional Mandiri Medan and the variables of occupational safety and health and job satisfaction have a positive and significant effect on the performance of employees of PT Bahari International Mandiri Medan.

A Pilot, Open-Label, Proof-of-Concept Study To Evaluate the Efficacy and Safety of Asthiposhak® Tablets in Participants Suffering From Asthikshaya or Osteopenia.

Introduction Both osteoporosis and osteopenia are prevalent public health concerns worldwide and can lead to debilitating bone fractures. This study aimed to assess the efficacy of Asthiposhak® Tablets in individuals with Asthikshaya (osteopenia) by measuring changes in the bone mineral density (BMD) score before and after the intervention, specifically between visit 1 (baseline) and visit 8 (after 180 days of treatment). Methods The single-arm study involved the screening of participants for Asthikshaya (osteopenia) using baseline investigations, which included a bone mineral density (BMD) assessment through a dual-energy X-ray absorptiometry (DEXA) scan. A total of 36 participants were enrolled in the study, who took two Asthiposhak Tablets three times a day with lukewarm water, for a period of 180 days. Safety assessments, along with evaluations of BMD (DEXA Scan), Ayurvedic Symptom Score, and serum biochemical markers, were conducted through blood investigations. Efficacy and safety data were analyzed using 'intention-to-treat' analysis. Descriptive statistics were used to express data in percentages, mean ± SD, or median (IQR). Data at different intervals were compared using paired t-tests or Wilcoxon signed-rank tests. One-way analysis of variance (ANOVA) with Bonferroni correction tested the significance between visits for the Ayurvedic Symptom Score, and Friedman's two-way analysis of variance by ranks measured differences in vital parameters. The significance level used was p<0.05. Results Out of the initially recruited 36 participants, 30 successfully completed the study, consisting of 12 males and 18 females, with an age range of 40 to 70 years and a mean age of 51.33 years. After 180 days of treatment with AsthiposhakTablets, a statistically significant (p<0.05) improvement in hip and spine BMD (T-score) was observed. Additionally, significant reductions in the mean Total Ayurvedic Symptom Score were noted at both 90 and 180 days of treatment compared to day 0. Moreover, the levels of bone-specific alkaline phosphatase and osteocalcin, serum bone markers, showed statistically significant (p<0.05) reduction after 180 days of treatment compared to day 0. Importantly, all safety variables, including laboratory investigations, remained within the normal range following the 180-day treatment with Asthiposhak Tablets. Conclusion AsthiposhakTablets exhibited significant efficacy in enhancing both BMD (T-score) and Ayurvedic Symptom Score, thereby substantiating their osteoprotective potential in individuals with Asthikshaya (osteopenia). Furthermore, the tablets were found to reduce the levels of biochemical markers, such as serum bone-specific alkaline phosphatase and osteocalcin, suggesting their anti-resorptive action.

ANALISIS PENGARUH VARIABEL KEPUASAN DAN KUALITAS PELAYANAN TERHADAP LOYALITAS PENUMPANG LINTAS PENYEBERANGAN KETAPANG – LEMBAR

The Ketapang-Lembar crossing will begin operations in April 2021. The construction of thiscrossing is intended to reduce the Gilimanuk-Denpasar traffic density and unravel the Padang Bai-Lembar crossing density. This research uses a quantitative method where the SmartPLS 3.0 application is used as a data analysis tool. Purposive sampling was the method used to collect data, and the sample was selected based on respondents who had used border transportation services at the Ketapang-Lembar crossing so that respondents had a general understanding of how to answer the questionnaire questions. The findings show that safety variables have the strongest influence on both customer satisfaction and loyalty when compared to comfort and reliability.

A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia.

Few data are available regarding the efficacy and safety of a single-pill combination (SPC) consisting of four medications in patients with concomitant hypertension and dyslipidemia. We aimed to determine the efficacy and tolerability of a fixed-dose SPC consisting of 5 mg amlodipine, 100 mg losartan, 20 mg rosuvastatin, and 10 mg ezetimibe (A/L/R/E) in patients with concomitant hypertension and dyslipidemia. This was a 14-week, randomized, multicenter, double-blind, placebo-controlled, phase III clinical trial. In total, 145 patients were randomized to receive A/L/R/E, A/L, or L/R/E. The primary endpoints were the average change in the low-density lipoprotein cholesterol (LDL-C) level in the A/L/R/E and A/L groups and the sitting systolic blood pressure (sitSBP) in the A/L/R/E and L/R/E groups. The numbers of patients with adverse drug reactions (ADRs) were compared as safety variables. The average percentage change in the LDL-C level as the least squares mean (LSM) from the baseline LDL-C level at the end of the 8-week treatment was -59.0% in the A/L/R/E group and 0.2% in the A/L group (LSM difference -59.2, 95% confidence interval [CI] -68.1 to -50.4; p<0.0001). The average change in the sitSBP as the LSM was -15.8 mmHg in the A/L/R/E group and -4.7 mmHg in the L/R/E group (LSM difference -11.1, 95% CI -16.8 to -5.4; p=0.0002). No ADRs occurred in the A/L/R/E group. A/L/R/E as an SPC could be an effective treatment for patients with hypertension and dyslipidemia without significant safety issues. NCT04074551 (registered 30 August 2019).

1803-PUB: Effectiveness and Safety of the Insulin Degludec U100 vs. Glargine U300 in People with Type 1 diabetes—The IneoxPlus Real-World Study

Objective: The INEOX-Plus study aims to compare the efficacy and safety of Deg-U100 and Gla-U300 in people with T1d incorporated to the Flash Glucose Monitoring (FGM) technology for over 6 months. Materials and Methods: Cross-sectional study in 161 of the 260 T1D participants of the INEOX randomized study (NCT 03328845) who were initially randomized between 2017 and 2019 to receive Gla-U300 or Deg-U100 insulin and incorporated to FGM technology after. Participants were re-evaluated in the INEOX_Plus visit, at an average 2.8 years after the final INEOX visit. Sociodemographic variables, insulin dose, plasma HbA1c and episodes of severe hypoglycemia and ketosis in the previous year were collected together with data on Freestyle libre 2® system downloaded from the last 90 days: sensor use, number of daily scans, GMI, mean glucose, CV, TIR 70-180, TBR 69-54, TBR &amp;lt;54, TAR 181-250, TAR &amp;gt;250 and hypoglycemia events- number/90 days and rate/year-. Results: 90 men (56%) and 71 women (44%), mean age 44±11 years, with diabetes evolution of 23.5±10 years belonging to the INEOX study accepted to participate; 75 subjects (46%) used Gla-U300 and 86 (54%) Deg-U100. A significant reduction in HbA1c was observed between the final INEOX and INEOX-Plus visit (7.65±1.04% vs 7.43±0.84%, p= 0.002) regardless of the type and dose of second-generation long-acting insulin analogue used. There were no episodes of severe hypoglycemia or ketoacidosis reported. We did not find significant differences in insulin doses, HbA1c and FGM metrics except in the Hypoglycemia events incidence rate -213.65 vs 260.05 events/person/year; p=0.001 - for Gla-U300 vs Deg-U100 respectively. Conclusions: For people with T1D in routine clinical follow-up with FGM, Gla-U300 and Deg-U100 insulin have a similar effect on the efficacy and safety variables except for significantly lower incidence rate of yearly hypoglycemia events for Gla-U300 users. Disclosure M.S.Ruiz de adana: None. L.I.Navas vela: None. C.Maldonado-araque: None. G.Olveira: Other Relationship; Abbott Diabetes, Novo Nordisk, Speaker's Bureau; Lilly. G.Rojo martínez: None. M.E.Domínguez-lópez: None. M.Vallejo mora: None. N.Colomo: None. F.Linares: None. V.Morillas: Other Relationship; Boehringer Ingelheim and Eli Lilly Alliance. M.Vallejo herrera: None. S.Alonso gallardo: None. M.Padilla fuentes: None. Funding Instituto de Salud Carlos III (PI 17/00861)