Real Practice Research Articles

Developing Understanding of Critical Thinking Definitions, Concepts and Characteristics in TVET Higher Education

This study aims to provide an understanding of critical thinking skills in TVET higher education context by investigating the definition, concept, and characteristics of critical thinking skills that is appropriate for the context. Therefore, a data collection is done through an interview involving ten lecturers from TVET higher education institutions purposely to gather their insight, perspectives, and real practice on critical thinking skills. The interview data are analysed using thematic analysis. It was discovered that the critical thinking concept for the TVET higher education context is a decision-making process. Critical thinking is defined as reflective and reasonable thinking, and critical thinking characteristics are the ability to adapt and analyse other alternatives. From the result of thematic analysis, this study developed a conceptual framework of critical thinking skills concept, definition and characteristics for TVET higher education setting. The findings could provide a reference for TVET higher education lectures to understand and apply critical thinking skills during teaching. In addition, other researchers can use the findings to develop fundamental knowledge in exploring and researching critical thinking skills.

The impact of an online gamified virtual tour on cognitive enhancement in dental practice management.

Dental practice management is usually a mandatory course for both undergraduate and postgraduate programs. However, learners and educators may encounter challenges in gaining experiences in real-life dental practice. The concept of a gamified virtual tour could have potential to improve dental practice management skills. A quasi-experimental study was conducted to evaluate the educational impact of a gamified virtual dental clinic (GVDC) on dental practice management skills among dental undergraduates (UG) and postgraduates (PG). All participants were assigned to complete the GVDC. Pre- and post-knowledge assessments were administered to evaluate knowledge acquisition. A self-administered questionnaire was distributed to investigate user perceptions toward the use of GVDC. There were 20 dental undergraduates and 20 orthodontic residents participating in UG and PG groups, respectively. Both groups demonstrated statistically significant increases in their assessment scores after completing the GVDC (P < 0.001). Although the pre-knowledge assessment score of the PG group was notably higher than that of the UG group (P = 0.041), there was no statistically significant difference in their post-knowledge assessment score (P = 0.491). Participants had positive perceptions of GVDC in terms of usefulness, ease of use, and enjoyment, with no statistically significant differences between the two groups (P > 0.05). Overall, the GVDC demonstrated positive educational impacts on acquiring knowledge and understanding of dental practice management, with participants expressing favorable perceptions of this immersive learning intervention.

Uncovering effects of supply chain distance on sustainability adoption: empirical evidence from a multi-stakeholder partnership

Purpose To investigate the effects of supply chain (SC) distance on sustainability adoption, this study aims to advance the way prior studies on SC sustainability presume that SC structures are well-developed and stable. Since SC members face structural voids in different regions, we recognize that the information flow is impacted as SC partners often have limited knowledge of their direct partners. Thus, by studying a multi-stakeholder partnership, this article sheds light on the institutional foundation of sustainability adoption issues largely neglected to date. Design/methodology/approach A qualitative case study was used with members of an MSP (i.e. a roundtable), to understand the beef SC located in Brazil. Overall, 18 h of interview recordings and notes from 18 h of meeting observations were gathered, equaling 36 h of primary data. Findings Four dimensions of SC distance (physical, organizational, cultural and institutional) were identified, generating three driving effects on symbolic sustainability adoption and, consequently, a degree of invisibility for beef SC members. The results explain the process of sustainability adoption and highlight that smaller and more upstream suppliers show lower degrees of substantive adoption of SC sustainability practices. Originality/value This study investigates how SC distance affects the alignment of SC members in terms of sustainability adoption. By providing reflections on how institutional distance can hinder suppliers from adopting sustainability requirements they received from the SC, this research contributes to shifting from sustainability discourse to real practice and proactive partner engagement.

Treatment of atopic dermatitis with abrocitinib in real practice in Spain: efficacy and safety results from a 24-week multicenter study.

Abrocitinib, a selective JAK 1 inhibitor, was recently approved in Europe. Despite its approval, real-world data on its efficacy and safety in treating moderate-to-severe atopic dermatitis (AD) remains limited. This study aimed to evaluate the short-term effectiveness and safety of abrocitinib in a real-life setting for patients with moderate-to-severe AD. We conducted a retrospective multicenter study involving adult patients with moderate-to-severe AD who started abrocitinib treatment between May 1, 2023, and September 30, 2023, in 15 Spanish hospitals. Treatment doses were 100 or 200 mg daily, based on clinical assessment. Data collection included patient demographics, AD history, comorbidities, previous treatments, and disease severity indicators such as SCORing atopic dermatitis (SCORAD), Eczema Area and Severity Index (EASI), body surface area, and Peak Pruritus NRS scores at baseline, 4, 12, and 24 weeks. Quality of life was measured using the Dermatology Life Quality Index (DLQI), and safety was assessed by monitoring adverse reactions and various biochemical parameters. The cohort comprised 76 patients with an average age of 33.93 years; 57.89% were male. Before abrocitinib, 36.84% were naïve to advanced therapies. The baseline mean scores were SCORAD 47.04, EASI 21.79, and DLQI 15.01. At Week 24, there were significant improvements: EASI was reduced to 2.81, and 70.58% of the patients achieved EASI 75. However, 18.42% discontinued treatment mainly due to inefficacy or adverse effects. The safety profile was favorable, with 22.37% reporting mild adverse events (AEs) and one serious case of cutaneous lymphoma. This first Spanish series assessing abrocitinib in real-world conditions reveals a significant improvement in AD symptoms and quality of life in a range of severity and prior treatment failures. Abrocitinib was well-tolerated, with few serious AEs, highlighting its potential as an effective treatment option for AD.

Prospectively predicting violent and aggressive incidents in prison practice with the Risk Screener Violence (RS-V): Results from a multisite prison study.

Preventing in-prison violence and maintaining a safe environment is an important goal within prison settings. Screening for violence risk may provide a valuable addition to reach this goal. Within the Dutch prison system, the Risk Screener Violence (RS-V) has become an important new element in overall risk management. Prior research shows that RS-V scores are a sound predictor of institutional violence and aggression of incarcerated persons. Whereas previous studies predominantly analyzed retrospective file-based data, the present study includes RS-Vs rated by prison employees in real-life prison practice shortly after implementation. The RS-Vs of 956 detained individuals from 25 Dutch prisons were analyzed. Disciplinary reports were consulted to measure violent and aggressive incidents during 4 months after the screening. In addition, detention duration (length of stay in prison before the screening) was included as an additional variable. Results of the present prison practice study show good predictive values of the RS-V ratings for violent and aggressive incidents during prison stay. The predictive validity was similar for prisoner-to-prisoner assault as well as prisoner-to-staff assault. In addition, the predictive validity of the RS-V scores did not differ between individuals with a longer detention duration versus individuals with a shorter detention duration. This multisite prison practice study is an important step in the further validation of the RS-V and shows that the RS-V is a valuable tool in determining who is more likely to show institutional violence. Nonetheless, it remains important to continually monitor the implementation and correct application of the RS-V in prison practice. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Glucosuria as a major mechanism-associated effect of sodium-glucose cotransporter 2 inhibitors: Is there cause for concern?

Introduction. One of the main mechanisms of action of SGLT2 inhibitors is an increase in renal excretion of glucose and sodium, development of glucosuria against the background of decreased levels of daily glycemia. The frequency of glucosuria development in patients without DM/prediabetes, receiving SGLT2 inhibitors for the treatment of CHD or CKD, as a consequence of the mechanism of action of SGLT2 inhibitors inhibitors is poorly studied and seems to be very interesting.Aim. To evaluate in real clinical practice the frequency of the development and severity of glucosuria in patients with CHF treated with inhibitors of SGLT2 inhibitors both on the background of concomitant DM2 and without type 2 DM.Materials and methods. Within the framework of a one-stage, prospective, observational study we evaluated the frequency of development and severity of glucosuria in patients with CHF, receiving SGLT2 inhibitors inhibitors, who were in the cardiology department of V.P. Demikhov State Clinical Hospital of Moscow. A total of 230 patients were included in the analysis.Results. The mean age of the patients was 74 [66; 83] years. Median LVEF was 36 [29; 44] %, NTproBNP 1019 [423; 2355] pg/ml. Heart failure with reduced ejection fraction (HFrEF) was recorded in 64.81% of patients, 17.13% had HF with mildly reduced ejection fraction and 18.06% had a СHF preserved ejection fraction. DM2 was present in 38.7 percent of patients with СHF. Among patients with CHF, the ‘glucosuria phenomenon’ due to the administration of SGLT2 inhibitors was observed in 31.16% of those without DM2, and in 52.27% of СHF patients with concomitant DM2.Conclusion. In patients with CHF receiving SGLT2 inhibitors therapy, the ‘glucosuria phenomenon’ developed in one in three patients without overt carbohydrate metabolism abnormalities and one in two with DM2. The findings suggest that the glucosuria effect of SGLT2 inhibitors is not a required event even in patients with DM2, which may influence the incidence of adverse events in general clinical practice. And the cardioprotective benefits of SGLT2 inhibitors may be due to other mechanisms unrelated to glucose excretion, which, according to recent studies, is considered a surrogate predictor of favorable prognosis concerning CHF and renal outcomes. Nevertheless, additional clinical and experimental studies are required to determine the cardioprotective mechanisms of SGLT2 inhibitors and the predictive value of drug-induced glucosuria.

Four-month real-life response to Tezepelumab in patients with multi-failure to other biologics

To evaluate the response to Tezepelumab in real clinical practice, we performed an analysis of the clinical, functional, and inflammatory characteristics of 13 patients with severe asthma after completing four doses of Tezepelumab was performed. When comparing clinical parameters such as asthma control test (ACT), FENO value, exacerbations in the last 4 months, blood eosinophils and FEV1%, before receiving Tezepelumab and after four doses of Tezepelumab, statistically significant differences were found in ACT levels (p=0.0072), exacerbations (p=0.018) and FEV1% (p=0.012) before and after four doses of Tezepelumab.No statistically significant differences were found in blood eosinophils or FeNO levels, however, a mean reduction of 102.5±231 cells/mm3 and 14.67±30 ppb, respectively, was observed. Patients with a high T2 profile had significantly higher baseline FeNO (p&lt;0.05), but no significant improvement in lung function or asthma control was observed in this group. Patients with Aspirin-exacerbated respiratory disease (AERD) were evaluated separately. There was no difference in ACT, FeNO, or lung function changes after tezepelumab use compared to patients without AERD (all p&gt;0.05). We demonstrated, in a multicenter study, the clinicalimprovement associated with tezepelumab treatment in severe uncontrolled asthma, independent of inflammatory biomarkers, eosinophilic profile, or previous biological failure.

Effect of metformin therapy on the development of vitamin B12 deficiency in patients with type 2 diabetes mellitus

Introduction. For the past decades, metformin has been the drug of choice for the treatment of patients with type 2 diabetes mellitus (T2DM). However, its long-term use leads to a number of side effects, such as the development of vitamin B12 deficiency (VB12).Aim. Assess the safety of metformin use in real clinical practice in the treatment of patients with type 2 diabetes based on the analysis of the incidence of VB12 deficiency.Materials and methods. Sixty patients with T2DM aged 27 to 65 years were examined in a city polyclinic. The average anamnestic duration of T2DM was 68 [4; 291] months. All patients were on selected hypoglycemic therapy: 19 patients (31.7%) received metformin monotherapy, and 41 patients (68.3%) received metformin as part of combination therapy. The average duration of metformin therapy was 62 [3; 291] months. All patients underwent analysis of the VB12 content in the blood serum depending on the duration of metformin intake. Results. The average VB12 level in the examined patients was 345 [99; 770] pg/ml. Normal VB12 levels were observed in 51 (85%) patients (386 [221; 770] pg/ml), VB12 deficiency (&lt;200 pg/ml) was detected in 9 (15%) patients (146 [99; 195] pg/ml), the differences between VB12 levels were significant (p &lt; 0.05). At the same time, in 37 (61.7%) patients with normal VB12 levels, its values were assessed as borderline (in the range of 200–450 pg/ml), and amounted to 335 [221; 470] pg/ml. VB12 deficiency developed more often in patients taking metformin for more than 1 year (16.7%), borderline VB12 levels were more often found in patients taking metformin for less than a year (58.3%) and more than 5 years (71%). However, the dependence of VB12 levels on the duration of metformin intake was not significant (p &gt; 0.05).Conclusion. Metformin use results in the development of VB12 deficiency in every sixth patient with T2DM, primarily after one year of treatment.

Study of the Structure and Properties of Concrete Modified with Nanofibrils and Nanospheres

The application of modifying nanoadditives in the technology of cement composites is currently a relevant and widely researched topic in global materials science. The purpose of this study was to investigate new nanoadditives—nanofibrils made from synthesized wollastonite (NF) and nanospheres from corundum (NS)—produced by LLC NPK Nanosystems (Rostov-on-Don, Russia) as a modifying additive. During the experimental investigations, the mechanical properties of cement pastes and concrete were examined. This included an analysis of the density, compressive and bending strength, as well as water absorption of concrete that had been modified with NF and NS additives. X-ray phase and microstructural analyses of concrete were performed. It was established that modification of cement composites with NF and NS additives had a beneficial effect on their properties, and the optimal amount for both types of additives was 0.3% by binder weight. The highest recorded enhancements in compressive and flexural strength of concrete with 0.3% NF were 7.22% and 7.04%, respectively, accompanied by a decrease in water absorption by 4.70%. When modifying concrete with 0.3% NS, the increases in compressive and flexural strength were 2.71% and 2.48%, and water absorption decreased by 1.96%. Modification of concrete with NF and NS additives did not have a significant effect on the change in concrete density, which was no more than 1%. Based on the results of phase analysis, it was established that concrete with NF and NS additives were characterized by the presence of five main phases: quartz, portlandite, calcite, larnite, and olivine-Ca. It was found that compositions with 0.3% NF and NS differed from the control composition by the presence of such a phase as olivine-Ca. Microstructural analysis confirmed the effectiveness of NF and NS additives. The microstructure of the modified concretes was distinguished by the extensive occurrence of clusters composed of calcium silicate hydrate zones. The conducted studies prove the possibility of using NF and NS as modifying nanoadditives in the technology of cement composites. The addition of nanofibrils from synthesized wollastonite is the most effective and promising and is recommended for use in real construction practice.

Challenges Experienced by Teachers when Integrating Indigenous Knowledge Systems in Natural Sciences Practical Work

This study explored what challenges teachers experienced when integrating indigenous knowledge systems (IKS), which are culture specific, into practical work in natural sciences classrooms with diverse learners. Using an exploratory qualitative case study based on an interpretive paradigm, three natural sciences teachers and two subject advisors were purposively selected from the Harry Gwala district in the KwaZulu–Natal province of South Africa. Semi-structured interviews, a focus group interview and practical work lesson observations were used to collect data that were analysed using thematic content analysis. The findings show that when indigenous knowledge was integrated with practical work, real-life activities were simulated in the classrooms. The introduction of real-life situations and IKS-based practical activities invited IKS-based learner behaviour. When simulating real-life practices, the learners’ socio-cultural beliefs became manifest. It was reported that learners assigned traditional gender roles for the practical work activities. Recent initiates into adulthood did not participate in activities that included the use of open fires because it was forbidden in their culture. Learners were also not willing to work with clay soil based on the belief that it attracted goblins, despite evidence showing its use in the building of huts and making of pots. Furthermore, teachers recognised the need to manage the conflicts and controversies that might result from integrating IKS into practical work. The study recommends education districts to establish contextualised resource centres for IKS integration that take into account the socio-cultural beliefs of local learners as a way to support the teachers.

A Systematic Investigation of Assessment Scores, Self-Efficacy, and Clinical Practice: Are They Related?

ABSTRACT A considerable amount of continuing professional development (CPD) for health professionals is online and voluntary. There is evidence that some CPD activities impact clinical practice outcomes from self-reported and objective, administrative data. Some studies have shown that there is a potential mediating effect of knowledge/competency and/or self-efficacy between participation in CPD activities and the outcomes of that participation, specifically clinical practice. However, because clinical practice in those studies has been self-report, little is known about how this relationship impacts real world clinical practice. The purpose of the current study is to examine the relationship between knowledge/competency, self-efficacy, and real-world clinical practice so that we can begin to understand whether our focus on knowledge/competency and self-efficacy to change real-world clinical practice is empirically supported. We employed secondary data analysis from pre-participation questionnaire and medical and pharmacy claims data originally collected in three evaluations of online CPD interventions to examine if the relationship between knowledge/competency and self-efficacy contributed to physicians’ real-world clinical practice. Results show an association between knowledge/competency scores and ratings of self-efficacy and suggest unique contributions of knowledge/competency and self-efficacy to clinical practice. Study results support the value of knowledge/competency scores and self-efficacy ratings as predictors of clinical practice. The effect size was larger for self-efficacy suggesting it may be a more practical indicator of clinical practice for CPD evaluators because its process of question development is simpler than the process for knowledge and case-based decision-making questions. However, it is important to conduct thorough need assessments which may include knowledge/competency assessments to identify topics to cover in CPD activities that are more likely to increase self-efficacy and ultimately, clinical practice.

Gastric neoplasm detection of computer-aided detection-assisted esophagogastroduodenoscopy changes with implement scenarios: a real-world study.

The implementation of computer-aided detection (CAD) devices in esophagogastroduodenoscopy (EGD) could autonomously identify gastric precancerous lesions and neoplasms and reduce the miss rate of gastric neoplasms in prospective trials. However, there is still insufficient evidence of their use in real-life clinical practice. A real-world, two-center study was conducted at Wenzhou Central Hospital (WCH) and Renmin Hospital of Wuhan University (RHWU). High biopsy rate and low biopsy rate strategies were adopted, and CAD devices were applied in 2019 and 2021 at WCH and RHWU, respectively. We compared differences in gastric precancerous and neoplasm detection of EGD before and after the use of CAD devices in the first half of the year. A total of 33 885 patients were included and 32 886 patients were ultimately analyzed. In WCH of which biopsy rate >95%, with the implementation of CAD, more the number of early gastric cancer divided by all gastric neoplasm (EGC/GN) (0.35% vs 0.59%, P=0.028, OR [95% CI]=1.65 [1.0-2.60]) was found, while gastric neoplasm detection rate (1.39% vs 1.36%, P=0.897, OR [95% CI]=0.98 [0.76-1.26]) remained stable. In RHWU of which biopsy rate <20%, the gastric neoplasm detection rate (1.78% vs 3.23%, P<0.001, OR [95% CI]=1.84 [1.33-2.54]) nearly doubled after the implementation of CAD, while there was no significant change in the EGC/GN. The application of CAD devices devoted to distinct increases in gastric neoplasm detection according to different biopsy strategies, which implied that CAD devices demonstrated assistance on gastric neoplasm detection while varied effectiveness according to different implementation scenarios.

Phosphodiesterase inhibitors and testicular torsion: A systematic review and meta-analysis of animal studies.

Testicular torsion is a common urological emergency in children and teenagers that, in most cases, requires surgical exploration and detorsion. However, even after a successful intervention, a high number of patients still develop irreversible damage. To investigate whether the administration of phosphodiesterase inhibitors (PDE) in animal models of testicular torsion can reduce damages caused by the ischemia-reperfusion syndrome. A systematic search of the Medline, Web of Science, Embase, and Ovid databases for studies up to December 2023 was performed using PRISMA guidelines. A detailed search was conducted using the following key terms: "testicles," "ischemia," "reperfusion," and "phosphodiesterase inhibitors." There was no restriction regarding language or year of publication. We investigated spermatogenesis by the Johnsen's biopsy score (JTBS) and histological damage by the Cosentino's biopsy score (CBS). Malondialdehyde (MDA), nitric oxide (NO), superoxide dismutase (SOD), and glutathione peroxidase (GPx) testicular levels were also analyzed. Initially, 296 articles were identified. However, only 20 studies met the inclusion criteria. PDE inhibitors improved JTBS (MD=2.53, CI=1.94 to 3.13), CBS (MD=-1.11, CI=-1.25 to -0.97) and SOD (SMD=3.27, CI=1.59 to 4.95) outcomes. PDE did not improve MDA (SMD=-0.93, CI=-2.19 to 0.34), NO (SMD=-0.54, CI=-1.56 to 0.48), and GPx (SMD=0.77, CI=-0.38 to 1.92) outcomes. A higher dose of PDE inhibitors only improved CBS outcome. This review indicates that the administration of PDE inhibitors in rats ameliorated the outcomes, representing a promising complementary strategy for spermatogenesis recovery following testicular torsion. Our review suggests that JTBS and CBS could be translated into future human studies, validating and extending these findings within the context of human physiopathology, while providing applicability of interventions in real clinical practice.

A higher adherence to perindopril-based anti-hypertensive therapy is associated with a reduced risk of cardiovascular outcomes and all-cause mortality in real clinical practice in Italy

Abstract Background Therapeutic management of hypertension is a landmark of cardiovascular (CV) risk prevention. Combined therapies with at least 2 anti-hypertensive agents are required in many patients in whom monotherapy and lifestyle interventions failed in blood pressure control. It is well-known that poor medication adherence remains a major barrier to achieving the therapeutic targets for all CV drugs, including anti-hypertensives. Purpose We evaluated the relationship between adherence to perindopril (PER)-based therapeutic regimen prescribed as single-pill combination (SPC) or free-pill and CV outcomes and all-cause mortality in a large Italian population. Methods A retrospective analysis was performed using administrative databases corresponding to around 6.7 million health-assisted residents. Hypertensive adults were first identified through hospitalization discharge diagnosis or exemption codes for hypertension between 2010 and 2021. Patients prescribed PER-based therapies were screened for all combinations of PER with amlodipine (AML) and/or indapamide (IND) (all formulations, single-pill or free-pill). Time of the first prescription of a PER-based regimen during the inclusion period was considered the index-date. The analysis included all hypertensive subjects prescribed a PER-based therapy, having available data at least 12 months before and 24 months after the index-date, respectively. Since the analysis was focused on the possible associations between adherence level and CV outcomes and all-cause mortality, adherence was assessed during the first year of follow-up on alive patients and outcomes were assessed during the second year. Adherence was assessed using the proportion of days covered (PDC) approach on 1-year follow-up, and considering a PDC&amp;lt;80% as poor-to-moderate adherence, and PDC ≥80% as good adherence. The Cox’s proportional hazard model was applied to estimate Hazard Ratio (HR) adjusting for baseline covariates, including comorbidity profile and pill burden. Results The included cohort (N=24,476) was divided into sub-groups according to adherence in poor-to-moderate (N=6,781) and good adherent patients (N=17,695) with a mean age of 64.8±13.3 and 64.6±11.9 years old, respectively. The Cox’s proportional hazard model showed that good adherence was associated with a relative risk reduction of 23% in all-cause mortality (Table 1A), 21% in all CV events (Table 1B), 17% in ischemic heart disease (Table 1C), 33% in cerebrovascular events (Table 1E), and 22% in the composite outcome of CV events/all-cause mortality (Table 1G). Conclusions The present analysis provided evidence from the Italian real clinical practice that good adherence to PER-based anti-hypertensive therapy results in significantly lower cardiovascular risk and all-cause mortality. These data further emphasize the importance of promoting cost-effective measures to increase medication adherence in patients on anti-hypertensive treatment.

Lipid-lowering therapy with Inclisiran in the real-world setting: initial data from a national health care service

Abstract Introduction Inclisiran, a first-in-class siRNA enabling long-term inhibition of PCSK9 synthesis, demonstrates good safety and efficacy profile in randomized clinical trials. Challenges for real-life use of inclisiran include limited access to therapy, injections by medical staff, lack of cardiovascular outcome data, and concern from adverse effects considering the novel mechanism and long-term activity. Real-life data on the potential to attain lipid-goals and reduce treatment gaps is lacking. We investigated the implementation of inclisiran in real-world clinical setting in Israel. Methods Data from a nationwide healthcare organization on patients initiating inclisiran therapy during the period of 3/2022-11/2023. Patients’ characteristics, efficacy, use of combination lipid-lowering therapies, and attainment of low-density lipoprotein cholesterol (LDL-C) goals, were evaluated. Results Inclisiran was initiated by 503 patients (57% women; mean age 66±11 years). Atherosclerotic cardiovascular disease was present in 54%, and peak historical LDL-C levels &amp;gt;190 mg/dL documented in 64%. Prior exposure to PCSK9 monoclonal antibodies was evident in 28%. Follow-up lipid profile &amp;gt;2 months after filling first prescription, was available in 397 patients (347 with ≥2 injections). In patients treated by inclisiran only (n=254), median LDL-C reduction from peak historical levels was 57% (IQR, 48%-67%), and from pre-injection levels 40% (19%-54%). In those with concomitant oral lipid-lowering therapies (n=143), median LDL-C reduction from peak levels was 66% (IQR, 55%-73%), and from pre-injection levels 46% (23%-59%) (Figure). LDL-C &amp;lt;70 mg/dL was attained by 39% and LDL-C &amp;lt;55 mg/dL by 21.9%. Of those treated with concomitant statin therapy, 38% attained LDL-C &amp;lt;55 mg/dL. Overall, 6.5% did not persist with inclisiran therapy after initial injection. Conclusions In real-life practice, inclisiran showed good efficacy with positive short-term adherence. However, attainment rates of lipid-goals were suboptimal due to limited use of combination lipid-lowering therapy and high-rates of severe hypercholesterolemia in our patient population cohort.Waterfall Plot of LDL-C (%) Reduction

Empaglifozin modifies the arterial stiffness in type-2 diabetic patients: a preliminary report.

Abstract Background Sodium-glucose cotransporter-2 (SGLT2) inhibitors demonstrated beneficial effects on cardiovascular and renal events in patients with type 2 diabetes mellitus. The mechanisms underlying these effects are not fully elucidated. Aim of this study was to investigate whether empagliflozin is able to modify the arterial stiffness in type 2 diabetic patients. Methods Pulse wave velocity (PWV) and other parameters of arterial stiffness were assessed before and after adding empagliflozin to a traditional antidiabetic treatment in 16 consecutive T2DM outpatients folowed for 3 months. Arterial stiffness were evaluted using SphygmoCor ECEL measuring the pulse waveform of the arterial pulse moving from tha descending aorta to the femoral artery (PWV). Data obtained from the diabetic population has been compared to 16 T2DM outpatients not treated with SGLT2 inhibitors. Results In the two groups differences according gender distribution or duration of diabetes mellitus did not emerge. However the empagliflozin group was younger compared to controls (64.1±8.68 vs 74.45±8.13, P &amp;lt; 0.05). Empagliflozin treatment significantly decreased HbA1c after 12 weeks of treatment (7.9±0.78 vs 7.04±1.09%, P &amp;lt; 0.008.). After 12 weeks’ treatment, empagliflozin significantly improved PWV compared to controls not treated with SGLT2-i (ΔPWVV -0.68±1.1 vs 0.89±1,6 p &amp;lt;0.004, P = 0.0065 with age and HbA1c as covariates). Moreover body weight significantly decreased in the empagliflozin group (86.75±16.16 vs 81.71±16.5 kg, p =0.001) compared to controls (in whom remained unchanged) as long as BMI (30.48±5.4 versus 28.75±5.66 kg/m2, P &amp;lt; 0.002) compared to controls (in whom remained unchanged). Estimated glomerular filtration rate (eGFR) remained unchanged in the two groups during the study whereas urine Albumin to Creatinine ratio significantly improved using empagliflozin (17.8±46.8 vs 12.2±35.7 mg/mmol, P = 0.049). Conclusion In this ‘real clinical practice’ experience, the potential effect of empagliflozin treatment on arterial stiffness in T2DM patients was extensively investigated. Arterial stiffness was significantly decreased adding empaglifozin to the traditional treatment and this result has been obtained after 3-month. Significantly improvement in urine Albumin to Creatinine ratio might suggest an amelioration of endothelial function in those patients that could be involved in reducing arterial stiffness.

Comparing the real-world and clinical trial bleeding rates associated with oral anticoagulation treatment for atrial fibrillation

Abstract Background The prevention of stroke in patients with atrial fibrillation (AF) involves the use of oral anticoagulation, commonly in the form of direct oral anticoagulants (DOAC). However, it comes with an increased risk of bleeding and therefore, counselling patients on their individual risk is important. Although majority of patients initiated on DOAC have been represented within the clinical trials, there are some cohorts which are under-represented in whom clinicians are unable to practice evidence-based medicine. Methods Utilising the pooled clinical trial (CT) data sourced from Medidata Enterprise Data Store, 5 recent open-label industry sponsored AF trials were compared with Real-World data (RWD) was sourced from the HealthVerity Marketplace with the occurrence of bleeding events as the primary outcome of interest. Results A total of 64,421 patients were included in the analysis, with 3207 patients from the clinical DOAC trials and 61,214 patients from the RWD cohort. Overall, the patients from RWD cohort had more co-morbidities, were older (72.2 ± 11.9 vs 65.3 ±10.7 years old, p&amp;lt;0.001), had higher mean CHA2DS2VASc (3.98 ± 1.9 vs 2.87 ± 1.73, p&amp;lt;0.001) and HAD-BLED scores (2.13 ± 1.02 vs 1/04 ± 0.93, p&amp;lt;0.001) when compared to the trial data. When comparing the incidence of first major bleed at 12 months post treatment initiation, rates in the RWD cohort was significantly higher (10.69 vs 18.97 per 100 person-years). The impact of comorbidities such as age, CHA2DS2VASc and HAD-BLED scores were similar in both cohorts, however, there was an under-representation of older, females and more co-morbid patients within the clinical trial cohort. Conclusion DOAC treated patients have higher bleeding incidence rate in the RWD cohort as compared to clinical trials. This can be explained by the older patient age group with more complex medical histories and higher HAS-BLED scores. The under-representation of higher risk patients and lower proportion of females within clinical trials should be addressed to better translate clinical trial data into real world clinical practice.

Side branch interventions late after MFM implantation

Abstract Background MFM prostheses were developed for the endovascular treatment of aortic and great vessel aneurysms. Implanted between two healthy segments of arterial vessel, they centralize blood flow and trough Bernoulli's principle. Thereby hemodynamic stress into the aneurismal sac is reduced. Meantime, the porosity along entire prosthesis length preserves all side branches (SB) patent. Results from real clinical practice confirm the high success rate (nearly 100%) of MFM prostheses regarding side branch preservation at one-year follow-up [1,2]. However, late after MFM implantation SB intervention may be required (due to atherosclerosis or others). The access to SB covered by MFM is challenging due to: impossible ostial engagement of the guiding catheter, distance between target vessel ostium and prosthesis, the necessary for all devices used to cross MFM mesh. Materials and methods For the period 2016-2020 we implanted a specific type of MFM prosthesis in order to treat aneurysm of the abdominal aorta in 34 patients. A total of 129 side branches was covered. Within a mean follow-up period of 5 years, 129 side branches were preserved and 7 affected by stenosis or occlusion (two of them asymptomatic). Intervention on the branch covered by the MFM prosthesis was necessary in 5 patients (two males, two females; mean age 68 years). One patient had endovascular celiac trunk stenosis, one patient had both celiac trunk and superior mesenteric artery stenoses, one patient had superior mesenteric artery stenosis, and one patient had left renal artery stenosis. All lesions were intervened through radial or brachial approach. Guiding 6F Judkins right catheter was navigated close to the target branch ostium and the MFM mesh was crossed with .014¨ coronary wire. When guidewire was placed into target vessel small low-profile, coronary balloon is advanced across the mesh of the multilayer stent. Anchor balloon technique was used in order for guiding catheter to cross the mesh gradually. Once the guiding catheter is engaged, the lesion was treated with balloon pre-dilation and implantation of a low-profile, high radial force stent. Results All 4 patients and 5 affected vessels were successfully endovascularly intervened. We did not observe any procedure complications. Immediate resolution of clinical symptoms was achieved. At 1 year follow-up with CT scan all treated branch arteries were patent. Conclusions In patients with previously implanted multilayer stents, the mesh can be crossed safely with readily available coronary devices together with the balloon anchor technique. As such, endovascular treatment of stent-covered visceral and renal arteries is possible without open surgery.Catheter stabilizationSMA successfully treated

Adherence to anti-hypertensive therapy with perindopril-based single-pill versus free-pill combinations: a 10-year real-world analysis in Italy

Abstract Background/Introduction Despite the growing availability of blood pressure-lowering drugs, hypertension remains poorly controlled and a significant mortality cause worldwide. The silent course of the disease, suboptimal adherence, and complexity of therapeutic schedules are important factors in reducing the effectiveness of anti-hypertensive treatments at the population level. With the purpose of simplifying patients’ medication self-management, guidelines have strongly endorsed the use of anti-hypertensive therapy with single-pill combinations (SPCs). Perindopril (PER)-based SPCs, including both two- and three-drug combinations, have been available since 2008. Purpose We explored treatment adherence over 10 years in patients receiving PER-based regimens (SPC or free-pill combination) in Italy. Methods A retrospective real-world analysis was conducted on administrative databases covering 6.7 million Italian health-assisted residents. Among adults with hospitalization discharge diagnosis or exemption code for hypertension between 2010 and 2021, those with PER-based prescriptions were identified, considering combinations with amlodipine (AML) and/or indapamide (IND), either as SPC or free-pill or mixed (SPC+separate pill). The index-date (ID) was that of the first prescription of a PER-based regimen throughout the inclusion period. All patients with at least 12 months of available data before and after the ID were included. A cross-sectional analysis evaluated the yearly adherence for the period 2012-2021, calculating the proportion of days covered (PDC) by drug prescriptions on 1-year follow-up (PDC≥80% indicated high-adherence). Results Over 2012-2021, of 121,397 patients on a PER-based therapy, those treated with SPC ranged from 87% (during 2012) to 94.4% (during 2021), while free-pill and SPC+separate pill cohorts represented, respectively, 10.6-3.5% and 2.4-2.1% of all hypertensive patients. Over the decade, the proportion of adherent patients in SPC users was markedly higher than in free-pill and SPC+separate pill cohorts (Fig. 1). The sudden reduction of adherent patients during 2018-2019 was possibly due to a temporary shortage of PER/AML/IND as SPC in Italy from Nov-2018 to Mar-2019. Multivariate analysis showed that over 2012-2021 decade, free-pill and SPC+separate pill regimens resulted in significantly lower adherence (more than 80% reduction) than SPC formulation, while male gender and older age were predictive of better adherence (Table 1). Conclusions These findings from real clinical practice in Italy highlighted a growing attitude from clinicians to prescribe more manageable anti-hypertensive schemes based on SPC formulations, in line with current guidelines. The higher proportion of adherent patients among the users of PER-based SPCs corroborates the importance of alleviating pill burden, that is a key component in blood pressure control, and so in the reduction of hypertensive complications and cardiovascular risk.

Real-world analysis exploring the association between anti-hypertensive therapy with perindopril-based single-pill combinations (SPC) and cardiovascular outcomes and all-cause mortality in Italy

Abstract Background/Introduction A combination of blood pressure (BP)-lowering medications is recommended by guidelines as an effective strategy to obtain rapid and optimal BP control in hypertensive patients. However, the prescription of multiple BP-lowering medications increases the pill burden, potentially reducing medication adherence. Guidelines also recommend using single pill combinations(SPCs) containing ≥2 anti-hypertensive medications as a practical approach to simplify treatment schedules and possibly improve adherence. Yet, real-world evidence on the association between SPC or free combination of BP-lowering medications and hyperthensive patient outcome remains limited. Purpose We compared the association of SPC versus free-pill combination(free) on cardiovascular outcomes and all-cause mortality in hypertensive patients treated with perindopril(PER)-based therapies in real clinical practice in Italy. Methods A retrospective analysis was conducted using administrative databases covering 6.7 million health-assisted Italian residents. Among adults with hospitalization discharge diagnosis or exemption code for hypertension between 2010 and 2021, the study included patients prescribed with a combination of PER with amlodipine(AML) and/or indapamide(IND), either as SPC or free or mixed (SPC plus separate pill) combinations. Results The analysis included 24,476 hypertensive subjects receiving a PER-based therapy, 22,663 (93%) of them using SPC, 1458 (6%) free and 355 (1.4%) mixed. The last cohort was not included in the analysis due to the small sample size (N=355). The patients in the free cohort were significantly older than those in the SPC cohort (69.5±12.3 vs. 64.3±12.2 years, p&amp;lt;0.001), showed a higher number of pre-existing comorbidities (0.5±0.8 vs. 0.4±0.7, p&amp;lt;0.001), and received a larger number of different medications (pill burden: 1.2±1.7 vs. 0.7±1.3, p&amp;lt;0.001). To minimize selection bias, the groups were balanced with propensity score and inverse probability weighting (IPW), adjusting for baseline covariates, including comorbidity profile and pill burden. The IPW-adjusted Kaplan-Meier plots and Cox’s proportional hazard model (Table 1) revealed that, compared with SPC users, patients on free regimens had a significantly increased risk of all-cause mortality (36%, p&amp;lt;0.001), all cardiovascular events (45%, p&amp;lt;0.001), ischemic heart disease (29%, p&amp;lt;0.05), cerebrovascular events (84%, p&amp;lt;0.001), and occurrence of the composite outcome cardiovascular events/all-cause mortality (40%, p&amp;lt;0.001). Conclusions This real-world data from a large Italian administrative dataset suggested that PER-based anti-hypertensive therapy with SPC results in significant clinical benefits in terms of lowered risk of cardiovascular/cerebrovascular events and all-cause mortality. Reducing pill burden and simplifying therapeutic schedules is of crucial importance to maximize the potential benefits derived from the prescription of anti-hypertensive treatment.