Bridging the gap: The future of biosimilars regulations.

Biosimilar vaccines and immunotherapeutic are innovative approaches in medical research. This commentary addresses the current disparities in regulations of biosimilar vaccines and immunotherapeutic products across different nations. It also navigates the benefits of global regulatory alignment and challenges that may be encountered. The current discrepancies in regulations across different countries, which pose significant challenges for the development and approval of biosimilar vaccines and immunotherapeutic products. These disparities often lead to delayed market access, increased development costs, and hindered innovation. The commentary stresses that such obstacles could be mitigated through harmonized regulations, resulting in faster approvals, reduced healthcare costs, and improved patient outcomes. Moreover, the commentary explores the specific complexities associated with biosimilar vaccines and immunotherapeutic, such as the intricate evaluation of biosimilarity due to their molecular composition and immunogenic properties. In conclusion, the editorial advocates for collaborative efforts to overcome the challenges in achieving global regulatory harmonization for biosimilars. This includes establishing uniform standards, fostering international cooperation among regulatory agencies, and promoting educational initiatives for healthcare providers and regulators. The ultimate goal is to ensure that patients worldwide have timely access to safe, effective, and affordable biosimilar treatments.

Determinants of Health-Related Quality of Life in Outpatients with Myocardial Infarction.

Background: The health-related quality of life (HRQOL) of patients with myocardial infarction (MI) is suboptimal because of the disease's life-threatening nature, the requirement for long-term lifestyle modifications, and the treatment regimens following MI. This study aimed to evaluate HRQOL and its associated factors in MI patients. Material and Methods: This study was conducted on patients with MI who attended the outpatient cardiology clinic at a major teaching hospital in Jordan. The EQ-5D-3L questionnaire was used to assess HRQOL of the study participants. Quantile regression analysis was conducted to identify the variables associated with HRQOL. Results: The study included 333 patients with a history of MI, with a median age of 58 (57-60). The median of the total EQ-5D score was 0.65 (0.216-0.805). Regression results revealed that male patients (Coefficient= 0.110, 95%Cl (0.022-0.197), P=0.014) and not being diagnosed with diabetes (Coefficient= 0.154, 95%Cl (0.042-0.266), P=0.007) were associated with increased HRQOL. On the other hand, low income (Coefficient= -0.115, 95%Cl (-0.203 - -0.026), P=0.011), not receiving DPP-4 (Dipeptidyl Peptidase -4) inhibitors (Coefficient= -0.321 95%Cl (-0.462 - -0.180), P<0.001), and having low (Coefficient= -0.271, 95%Cl (-0.395 - -0.147), P<0.001) or moderate (Coefficient= -0.123, 95%Cl (-0.202 - -0.044), P=0.002) medication adherence was associated with decreased HRQOL. Conclusion: The current study demonstrated diminished HRQOL among patients with MI, highlighting the necessity of tailoring interventions to tackle medication adherence barriers in this population. Personalized interventions such as educational programs, counseling, and reminders that consider each patient's needs and circumstances can greatly enhance medication adherence and, thus, the HRQOL of MI patients. Individuals with lower income levels, female patients, and those with diabetes should be the specific targets of these interventions.

Confidence, attitude, and practice of scientific research among health professions' students in the United Arab Emirates.

OBJECTIVE: This study aimed to assess the confidence, attitude, and scientific research practices of undergraduate students of different health profession specialties. METHODS: In this cross-sectional study, an online-based questionnaire was distributed as a Google Form via groups and pages of medical universities available on social media sites such as Facebook, WhatsApp, and Twitter to the second- to sixth-year students of different health profession specialties in different universities across the United Arab Emirates (UAE) in the period from October through December 2023 using the convenience sampling technique. The questionnaire included four parts that assessed socio-demographics and custom-designed research-related questions (6 items), perceived confidence (8 items), attitudes (14 items), and the practice in the context of scientific research and its implementation (9 items). Multivariate logistic regression analyses were conducted to explore the variables associated with the study outcomes, including confidence, attitudes, and practice levels. RESULTS: The study included 522 undergraduate students. The participants reported low confidence, a negative attitude, and low scientific research practice. Regression results revealed that individuals without prior research experiences were less likely to have high confidence and practice compared to those with previous research experience (OR = 0.634, 95% CI: 0.426-0.945, p = 0.025; and OR = 0.139, 95%Cl: 0.090-0.216, P<0.001, respectively). Additionally, participants who reported difficulty in differentiating between various literature resources were less likely to have high confidence and practice compared to those who reported the ability to differentiate (OR = 0.627, 95% CI: 0.42-0.935, p = 0.022, and OR = 0.370, 95%Cl: 0.237-0.579, p<0.001, respectively). Furthermore, individuals who had not taught research methods in their undergraduate studies were less likely to have high practice (OR = 0.505, 95%Cl: 0.309-0.823, p = 0.06). CONCLUSIONS: Undergraduates of different medical specialties in the UAE demonstrated acceptable levels of confidence and attitude toward scientific research, with several areas for practice improvement. Education and training courses focusing on various aspects of scientific research should be incorporated into the medical curricula in order to enhance students' confidence and practice of scientific research.

Factors associated with anxiety and depression among patients with chronic obstructive pulmonary disease.

OBJECTIVES: This study investigated factors associated with anxiety and depression in COPD outpatients. METHODS: A cross-sectional study of 702 COPD outpatients from two major Jordanian hospitals using the Hospital Anxiety and Depression Scale (HADS) was conducted. RESULTS: Significant associations were found with gender (Anxiety OR: 5.29, 95%CI: 2.38-11.74; Depression OR: 0.20, 95%CI: 0.08-0.51), disease severity (Anxiety OR: 2.97, 95%CI: 1.80-4.91; Depression OR: 15.95, 95%CI: 5.32-52.63), LABA use (Anxiety OR: 16.12, 95%CI: 8.26-32.26; Depression OR: 16.95, 95%CI: 8.33-34.48), medication count (Anxiety OR: 0.73, 95%CI: 0.59-0.90; Depression OR: 0.51, 95%CI: 0.40-0.64), mMRC score (Anxiety OR: 2.41, 95%CI: 1.81-3.22; Depression OR: 2.31, 95%CI: 1.76-3.03), and inhalation technique (Anxiety OR: 0.95, 95%CI: 0.93-0.97; Depression OR: 0.92, 95%CI: 0.90-0.95). Other factors associated with anxiety included high income, urban living, diabetes, hypertension, LAMA use, and fewer COPD medications. Depression was also linked with heart disease, increased age, and longer disease duration. CONCLUSION: The prevalence of anxiety and depression among COPD patients necessitates targeted interventions. Future research that recruits a more diverse sample in multiple sites and establishes the cause-effect relationship between the study predictors and outcome could provide a more robust conclusion on factors associated with anxiety and depression among COPD patients.

Medication Adherence and Its Associated Factors Among Outpatients with Heart Failure.

Background: Poor adherence to heart failure (HF) medications represents a major barrier to achieve the desired health outcomes in those patients. Objective: To assess medication adherence and to explore the factors associated with medication non-adherence among patient with HF in Jordan. Methods: The current cross-sectional study was conducted at the outpatient cardiology clinics at two main hospitals in Jordan from August 2021 through April 2022. Variables including socio-demographics, biomedical variables, in addition to disease and medication characteristics were collected using medical records and custom-designed questionnaire. Medication adherence was assessed using the 4-item Morisky Medication Adherence Scale. Multinomial logistic regression analysis was performed to identify the factors that are significantly and independently associated with medication non-adherence. Results: Of the 427 participating patients, 92.5% had low to moderate medication adherence. Results of the regression analysis revealed that that patients who had higher education level (OR=3.36; 95% CI 1.08-10.43; P=0.04) and were not suffering from medication-related side effects (OR=4.7; 95% CI 1.91-11.5; P=0.001) had significantly higher odds of being in the moderate adherence group. Patients who were taking statins (OR=16.59; 95% CI 1.79-153.98; P=0.01) or ACEIs/ ARBs (OR=3.95; 95% CI 1.01-15.41; P=0.04) had significantly higher odds of being in the high adherence group. Furthermore, Patients who were not taking anticoagulants had higher odds of being in the moderate (OR=2.77; 95% CI 1.2-6.46; P=0.02) and high (OR=4.11; 95% CI 1.27-13.36; P=0.02) adherence groups when compared to patients who were taking anticoagulants. Conclusion: The poor medication adherence in the present study sheds the light on the importance of implementing intervention programs which focus on improving patients' perception about the prescribed medications particularly for patients who have low educational levels, receive an anticoagulant, and do not receive a statin or an ACEI/ ARB.

Variables associated with asthma control among adult patients.

Objective: Asthma is one of the most prevalent chronic diseases with a substantial impact on the health status of affected patients. Further research is necessary to identify factors contributing to poor asthma control. The current study aimed to investigate the factors associated with poor asthma control among adult asthmatic patients.Methods: In this case-control study, the Asthma Control Test (ACT) was translated into Arabic and distributed to adults with asthma attending two hospitals in Jordan to evaluate the degree of asthma control. The following variables were collected for each patient: sociodemographic information, comorbidities, appropriate use of inhaler technique, spirometric measurements, and medications use. Binary regression was used to evaluate factors associated with asthma control.Results: A total of 314 participants with a mean age of 51.47 years (±16.37) completed the study. ACT score had a mean of 16.68 (±4.86). The majority of asthmatic patients had insufficiently controlled asthma (64.6%). Binary regression results showed that previous respiratory infection history (p = 0.014, OR = 0.473 (95%CI 0.261-0.857)), higher exposure to irritants (p = 0.010, OR = 0.747 (95%CI 0.598-0.933)) decreased the odds of being in the controlled asthma group. Patients receiving inhaled corticosteroids (ICS) had higher odds of being in the controlled asthma group (p = 0.039, OR = 2.372 (95%CI 1.043-5.392)).Conclusions: The majority of asthma patients had insufficiently managed disease. The main factors that contributed to poor asthma control were respiratory infection history, increased exposure to asthma symptoms triggers, and ICS nonuse.

Iraqi Parents' Knowledge, Attitudes, and Practices towards Vaccinating Their Children: A Cross-Sectional Study.

The focus of coronavirus disease 2019 (COVID-19) vaccination campaigns has been the adult population, particularly the elderly and those with chronic diseases. However, COVID-19 can also affect children and adolescents. Furthermore, targeting this population can accelerate the attainment of herd immunity. The aim of the current study was to evaluate parental intentions to vaccinate their children and the variables associated with them. An online questionnaire was circulated via generic Iraqi Facebook groups to explore parental intentions regarding the vaccination of their children. Multinomial regression analysis was conducted to evaluate variables associated with parental vaccination acceptance. A total of 491 participants completed the study questionnaire. Only 38.3% of the participants were willing to vaccinate their children against COVID-19, while the rest either refused to vaccinate their children (35.6%) or were unsure whether they would (26.1%). Participants' perceptions about the effectiveness (OR = 0.726, 95% CI = 0.541−0.975, p = 0.033) and safety (OR = 0.435, 95% CI = 0.330−0.574, p < 0.0001) of COVID-19 vaccines were significantly associated with parental acceptance of having children vaccinated. Participants who had received or who were planning to receive the COVID-19 vaccine were significantly less likely to reject vaccinating their children (OR = 0.156, 95% CI = 0.063−0.387, p < 0.0001). There is high refusal/hesitancy among Iraqi parents to vaccinate their children, which is associated with concerns related to the safety and efficacy of COVID-19 vaccines. More efforts, including educational and awareness campaigns to promote the safety and efficacy of COVID-19 vaccines, should be made to increase parental acceptance of childhood COVID-19 vaccinations in Iraq.