A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA (R)) to the reference product (Humira (R)) in patients with active rheumatoid arthritis

Background: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA (R), CinnaGen, Iran) to the innovator product (Humira (R), AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). Methods: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA (R) or Humira (R) every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a period of 24 weeks. Physical examinations, vital sign evaluations, and laboratory tests were conducted in patients at baseline and at 12-week and 24-week visits. The primary endpoint in this study was the proportion of patients achieving moderate and good disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR)-based European League Against Rheumatism (EULAR) response. The secondary endpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for 20% (ACR20), 50% (ACR50), and 70% (ACR70) responses along with the disability index of health assessment questionnaire (HAQ), and safety. Results: Patients who were randomized to CinnoRA (R) or Humira (R) arms had comparable demographic information, laboratory results, and disease characteristics at baseline. The proportion of patients achieving good and moderate EULAR responses in the CinnoRA (R) group was non-inferior to the Humira (R) group at 12 and 24 weeks based on both intention-to-treat (ITT) and per-protocol (PP) populations (all p values >0.05). No significant difference was noted in the proportion of patients attaining ACR20, ACR50, and ACR70 responses in the CinnoRA (R) and Humira (R) groups (all p values >0.05). Further, the difference in HAQ scores and safety outcome measures between treatment arms was not statistically significant. Conclusion: CinnoRA (R) was shown to be non-inferior to Humira (R) in terms of efficacy at week 24 with a comparable safety profile to the reference product

Medical student and academic staff perceptions of role models: an analytical cross-sectional study

BACKGROUND: This study explored the associations between the perceptions of students and the perceptions of academic staff about the characteristics of clinical lecturers at the Department of Internal Medicine at Kerman University of Medical Sciences (KUMS). It also assessed what characteristics constitute a 'role model' from the point of view of students and staff. METHODS: Staff and students were questioned about the characteristics of their colleagues and lecturers, respectively. They were asked about 15 characteristics under four headings: personality, teaching skill, group working and overall performance as a role model. Associations between lecturers' characteristics were explored using Pearson correlation and characteristics were allocated into groups by partition cluster method. In addition, predictors of being a valuable lecturer were assessed using logistic regression analysis. RESULTS: Based on staff responses, the strongest association observed was between honesty and being respectful (r = 0.93, p < 0.0001). Based on student responses, the strongest association observed was between being professional and honesty (r = 0.98, p < 0.0001). None of the correlations between student and staff perceptions were significant for any characteristic. Two groups were recognized among the characteristics. group one contained those characteristics which were related to the lecturer's activity; while the second group contained characteristics that were related to the personality or teaching performance of the lecturer. The predictors of lecturer as 'role model' (i.e., perceptions of students) consisted mostly of characteristics from the first group, while the predictors of a 'role model' by fellow academic staff consisted of characteristics that were in both groups. CONCLUSION: These findings showed considerable differences between the perceptions of students about their lecturers when compared with perceptions of staff about their colleagues. Students were more concerned with the personality of their lecturers, while staff also considered their ideas and behaviors. This suggests that a more comprehensive assessment of a lecturer's performance could be obtained by taking into account feedback from both students and colleagues

Coping Strategies to Hinder Intention to Leave in Iranian Nurses: A Qualitative Content Analysis

Background: Due to the high clinical challenges, differences in coping strategies, and high workload in nurses, there is a need to develop strategies to keep them in the profession. The aim of the present study was to explore the Iranian nurses’ coping strategies to deal with intention to leave. Methods: A qualitative content analysis was used to obtain rich data. We performed 13 in-depth face-to-face semi-structured interviews with nurses working in hospitals affiliated to Tabriz and Urmia Universities of Medical Sciences in Iran, selected through purposive sampling. Constant comparative method was used for data analysis. Results: Three categories and eleven subcategories emerged during data analysis. The extracted categories and sub-categories consisted of (I) Self-empowerment (practical knowledge increase, responsibility, finding identification of the nurse, balancing work and life, seek support and humanitarian interests), (II) Self-controlling (tolerance, avoidance, the routine-based performance), and (III) Pursuing opportunities for advancement and promotion (community development, planning for higher education). Conclusion: Nurses make attempts to individually manage problems and stressors perceived from bedside that have led them to leave the bedside; these efforts have been effective in some cases but sometimes they are ineffective due to discontinuous training and relative competence in terms of how to manage and deal with problems. It is suggested that nurses should learn strategies scientifically to meet the challenges of bedside. Through enabling and supporting behaviors and creating opportunities for growth and professional development, nursery managers can help nurses to stay and achieve improvement of the quality of cares

Determining valid criteria for evaluating clinical and theoretical teaching of the faculty of Kerman University of Medical Sciences

Background: To improve the quality of education, evaluating clinical and theoretical teaching and giving feedbacks to the teachers to obviate the drawbacks is of important value. Evaluation results are reliable if the gathered data are correct and precise and it can be achieved only if there are precise tools to gather data. This study was performed to prepare valid forms to evaluate theoretical and clinical teaching. An appropriate weight has been allocated to each item. Method: Separate checklists were designed for students, in order to evaluate theoretical and clinical teaching. Also special forms were developed for teacher evaluations by heads of departments and school deans .School deans ,on the other hand, completed special checklists to evaluate vice-deans and head of departments. Using the expert’s attitudes, the validity was calculated by Delphi method and the weight of different items was calculated by trim mean. Findings: The questionnaire had different categories including discipline, teaching method, scientific level and evaluation. The longest forms had 17 items (theoretical and practical teaching). The highest validity coefficient was 0.9 0.07 and the lowest was 0.83 0.03. The most important item in theoretical teaching was scientific level of teachers and in clinical teaching, it was on time attendance. Conclusion. Designing checklist for assessment of achievement in educational objectives is very essential and it must be precise and correct. The item must be checked because of changing educational context

Experiences of Iranian Nurses that Intent to Leave the Clinical Nursing: a Content Analysis

Introduction: Despite the current shortage of nurses, it is important to know the reasons nurses want to leave the clinical setting. The purpose of this study was to explore the experiences of nurses who intend to leave clinical nursing. Methods: In a qualitative content analysis study, data obtained from 13 in-depth face-to-face semi-structured interviews with nurses working in hospitals affiliated to the Tabriz and Urmia University of Medical Sciences in Iran, selected through purposive sampling. A conventional content analysis was used for data analysis. Results: Four categories and eleven subcategories emerged during data analysis. The extracted categories and sub categories consisted of (I) Entry routes into nursing (implicitly entry, targeted entry), (II) Defects in dignity (lack of professional vision toward the nurses, social status of nurses), (III) Work in non-ideal working environment (lack of support, discrimination, conflict, lack of opportunities for advancement), and (IV) Dissatisfaction with working conditions (heavy workload, lack of power, unusual working hours). Conclusion: The findings of this qualitative study reflect professional turnover as a complex, ongoing, multidimensional process. By identifying the factors responsible, it could be possible to retain nurses in the field