Are We Scared of Clinical Trials if Not Sufficiently Informed and Educated?

Purpose: Educational interventions have already been shown to positively affect awareness of clinical trials (CTs) among medical students. We aimed to explore basic knowledge and attitudes about CTs among medical students in terms of educational interventions that should be reflected in their further involvement in performing CTs and their role in raising awareness about CTs. Methods: This cross-sectional, self-report anonymous online survey involved undergraduate medical students of the Medical Faculty University of Sarajevo enrolled in classes held within the Department of Pharmacology and Toxicology in the academic year 2015-2016. To include all accessible subjects for better representation of the whole population, consecutive sampling was applied. Results: Among 142 students who completed questionnaire, 50% of them expressed partial or full agreement with the questionnaire statement that they were satisfied with the available information on CTs. Only 38% said they would participate in a CT, 21% would not, while 41% were not sure. Positive correlations were detected for composite subscale scores of agreement with questionnaire statements conveying the student's knowledge about ethical and legal aspects of CTs and their perception about reliability/integrity and impact of CTs on medical practice. Conclusion: Students have knowledge of the basic design and ethical aspects of CTs. Positive attitudes toward the impact of CTs on medical practice were shown in students of higher years of study, where educational intervention of additional knowledge of CTs was inserted and those students expressed better knowledge of CTs. However, no significant impact was detected between knowledge and willingness to participate in CTs, irrespective of years of study, reflecting the third of students that would participate in CTs. Changes in medical curricula led to the change in students' knowledge and attitudes regarding CTs as well as their involvement in CTs.

Sleep quality and patterns of young West Balkan adults during the third wave of COVID-19 pandemic: a cross-sectional study.

OBJECTIVES: To evaluate the sleep patterns among young West Balkan adults during the third wave of the COVID-19 pandemic. DESIGN AND SETTING: Cross-sectional study conducted using an anonymous online questionnaire based on established sleep questionnaires Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) (February-August 2021). PARTICIPANTS: Young adults of Bosnia and Herzegovina, Croatia and Serbia. RESULTS: Of 1058 subjects, mean age was 28.19±9.29 years; majority were women (81.4%) and students (61.9%). Compared with before the pandemic, 528 subjects (49.9%) reported a change in sleeping patterns during the pandemic, with 47.3% subjects reporting sleeping less. Mean sleeping duration during the COVID-19 pandemic was 7.71±2.14 hours with median sleep latency of 20 (10.0-30.0) min. Only 91 (8.6%) subjects reported consuming sleeping medications. Of all, 574 (54.2%) subjects had ISI score >7, with majority (71.2%) having subthreshold insomnia, and 618 (58.4%) PSQI score ≥5, thus indicating poor sleep quality. Of 656 (62.0%) tested subjects, 464 (43.9%) were COVID-19 positive (both symptomatic and asymptomatic) who were 48.8%, next to women (70%), more likely to have insomnia symptoms; and 66.9% were more likely to have poor sleep quality. Subjects using sleep medication were 44 times, and subjects being positive to ISI 15.36 times more likely to have poor sleep quality. In contrast, being a student was a negative independent predictor for both insomnia symptoms and poor sleep quality, and mental labour and not working were negative independent predictors for insomnia symptoms. CONCLUSIONS: During the third wave of the pandemic, sleep patterns were impaired in about half of young West Balkan adults, with COVID-19-positive subjects and being women as positive independent predictors and being a student as negative independent predictor of impaired sleep pattern. Due to its importance in long-term health outcomes, sleep quality in young adults, especially COVID-19-positive ones, should be thoroughly assessed.

Pharmacogenetics of new classes of antidiabetic drugs.

Type 2 diabetes (T2D) has a continuously rising prevalence worldwide. Pharmacogenetics has been recognized as a promising concept for pharmacological treatment of T2D, as antidiabetic drugs are not equally effective and safe for all patients, and the costs of diabetes treatment are increasing. The latest published guidelines on T2D treatment firmly endorse the use of newer antidiabetic drugs, sodium-glucose cotransporter-2 inhibitors (SGLT2i), dipeptidyl peptidase-4 inhibitors (DPP-IVi), and glucagon-like peptide-1 receptor agonists (GLP-1RA), considering their satisfactory pharmacological effect and good safety profile. Furthermore, SGLT2i and GLP-1RA show protective effects in patients with established atherosclerotic cardiovascular disease and chronic kidney disease. However, there has been growing evidence that the effectiveness and safety of these drug classes could depend on genetic variability. Here, we summarized the results of the published studies on the pharmacogenetic biomarkers for the three drug classes. A number of genetic variations have been investigated so far. The explored candidate genes mostly encode drug targets, drug-metabolizing enzymes, and genes linked to T2D risk. Although many of the results are promising, it is still necessary to obtain more information from larger controlled studies to confirm their clinical significance. This approach may lead towards more personalized treatment for patients with T2D.

Role of inhaled corticosteroids in the exacerbation rate of moderate chronic obstructive pulmonary disease.

Aim To analyse frequency of chronic obstructive pulmonary disease (COPD) exacerbation in patients on therapy with inhaled corticosteroids (ICS) and relevant factors that influence the rate of COPD exacerbations in a subgroup of moderate illness, like FEV1, comorbidities and other concomitant therapy. Methods The study included patients with moderate COPD with at least 10 pack-years history of smoking and accompanying cardiovascular comorbidity. Demographic data, frequency of exacerbations and information about proscribed treatments - ICS alone or in combination with long acting beta agonist (LABA), were collected from medical records for the previous 12 months from the index date. Results Data were collected for 210 patients (170 males) with the mean age 65.63±8.66 years, 72 of which were treated with a fixed combination of long acting beta blocker (LABA) and ICS. Significantly more frequent exacerbations were detected in patients using ICS p<0.0001) and having higher Modified British Medical Research Council (mMRC) score p=0.004). No statistically significant difference was registered related to ratio of FEV1 /FVC (p=0.121) or a number of cardiovascular comorbidities per patient (p=0.969). CONCLUSIONS: Our results present a small contribution to the current scientific discussion about the use of ICS in COPD treatment. Further prospective studies are needed to confirm the impact of ICS on the frequency of COPD exacerbations.

Metformin use associated with lower risk of cancer in patients with diabetes mellitus type 2.

Aim In order to increase the database related to the antineoplastic potential of metformin, association between the use of metformin and risk of cancer occurence in patients with diabetes mellitus type 2 (DM2) was investigated. Methods In this cross-sectional study, medical records of patients with DM2 were reviewed for cancer occurence. Data on age, body mass index (BMI), alcohol and nicotine consumption, glucose and HbA1c levels, duration of DM2, medication used in the treatment of DM2 and cancer occurence were collected and analyzed. Unpaired Student's t-test or Mann-Whitney U test were used for comparisons between treatment groups, and logistic regression to asses how well our set of predictor variables predicts occurence of carcinoma. P-value less than 0.05 was considered statistically significant. Results The mean age of 234 included patients was 66.8±11.5 years, and DM2 duration was 7± 6.49 years. Mean glucose value was 8.51±4.17mmol/L, and HbA1c 7.74±1.53. Metformin therapy was prescribed in 190 (81%) patients. Cancer was diagnosed in 16 (6.8%) patients: prostate cancer in eight (3.4%), breast cancer in four (1.7%), rectal cancer in two (0.9%) and cancer of the uterus and cervix in one patient. Age, duration of DM2 and BMI did not contribute significantly to the model, while metformin use was shown to be a significant independent predictor (OR=0.049; 95% CI=0.013-0.181; p=0.001). Conclusion Our findings support the hypothesis that the use of metformin compared to the use of other oral antidiabetic drugs is associated with a lower risk of cancer in patients with DM2.

Non-invasive liver fibrosis markers: use of serum levels of cytokines IL 1α and TGF ß1 in management of chronic liver diseases.

AIM: To analyze the usefulness of specified immunological parameters, proinflammatory IL-1α and profibrogenic, antiinflammatory TGF-ß1, along with routinely used laboratory tests, in the differential - diagnostic procedure of chronic hepatitis of infectious and noninfectious etiology. METHODS: A total of 150 subjects were divided into two groups, depending on the infectious or noninfectious etiology of liver damage, and the control group. Apart from standard laboratory tests, the analysis included serum levels of cytokines: IL-1α and TGF-ß1. RESULTS: A high degree of correlation of serum level of IL-1α with viral hepatitis has been found, especially with active replication of genetic material ( HBV-DNA or HCV-RNA-PCR positive), p less 0.01. The highest mean concentration of TGF-ß1 was noted in the group of malignant and toxic hepatitis, p less 0.0001. A negative correlation between the concentration of IL-1α and TGF-ß1 has been found (-0.18). For IL-1 α significant predictive parameters included a previous infection of hepatitis B, lower serum level of TGFß, age, use of alcohol, lower MELD and Chilld-Pugh scores. For TGF-ß1 significant predictive parameters were age, lower MELD and Child-Pugh scores, history of receiving transfusions, lower serum level of IL-1α, higher serum level of fibrinogen. A predictive model has been delivered MELD = (TGF-ß1) x 0,001- (IL-1 α) x 0,085 + CTP x 1,771-2,052; ( ± 2.04, R2=0,61; p less 0,001). CONCLUSION: Inflammatory and immune parameters, analyzed together could significantly contribute to the understanding of chronic liver damage and thus differential diagnostic procedure. IL-1α and TGF-ß1 are important parameters of inflammatory activity and fibrosis evaluation in chronic liver damage.