Radical reform of the undergraduate medical education program in a developing country: the Egyptian experience.

Medical educators are in a continuous quest to close the gap between the needs of medical practice and the rising expectations of the communities in their countries. During the past two decades, competency-based medical education has been evolving as an appealing strategy to close this gap. In 2017, the Egyptian medical education authorities mandated all medical schools to change their curricula to comply with revised national academic reference standards, which changed from outcome-based to competency-based. In parallel, they also changed the timeline of all medical programs for six years of studentship and one-year internship to five years and two years, respectively. This substantial reform involved the assessment of the existing situation, an awareness campaign for the proposed changes and an extensive national faculty development program. Monitoring the implementation of this substantial reform was performed through surveys, field visits and meetings with students, teaching staff and program directors. In addition to the expected challenges, the COVID-19-associated restrictions presented a significant further challenge during the implementation of this reform. This article presents the rationale for and steps of this reform, the challenges faced and how they were addressed.

Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project.

BACKGROUND: We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases. RESULT: The authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries. CONCLUSION: This work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/CAs. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort.

The ethical framework for performing research with rare inherited neurometabolic disease patients.

The need for performing clinical trials to develop well-studied and appropriate medicines for inherited neurometabolic disease patients faces ethical concerns mainly raising from four aspects: the diseases are rare; include young and very young patients; the neurological impairment may compromise the capability to provide 'consent'; and the genetic nature of the disease leads to further ethical implications. This work is intended to identify the ethical provisions applicable to clinical research involving these patients and to evaluate if these cover the ethical issues. Three searches have been performed on the European regulatory/legal framework, the literature and European Union-funded projects. The European legal framework offers a number of ethical provisions ruling the clinical research on paediatric, rare, inherited diseases with neurological symptoms. In the literature, relevant publications deal with informed consent, newborn genetic screenings, gene therapy and rights/interests of research participants. Additional information raised from European projects on sharing patients' data from different countries, the need to fill the gap of the regulatory framework and to improve information to stakeholders and patients/families. CONCLUSION: Several recommendations and guidelines on ethical aspects are applicable to the inherited neurometabolic disease research in Europe, even though they suffer from the lack of a common ethical approach. What is Known: • When planning and conducting clinical trials, sponsors and researchers know that clinical trials are to be performed according to well-established ethical rules, and patients should be aware about their rights. • In the cases of paediatric patients, vulnerable patients unable to provide consent, genetic diseases' further rules apply. What is New: • This work discusses which ethical rules apply to ensure protection of patient's rights if all the above-mentioned features coexist. • This work shows available data and information on how these rules have been applied.

Moving Together, Apart: Impacts of Travel Restrictions on a UK-Egypt Collaboration in Health Profession Education.

Objective: University College London (UCL) and Newgiza University (NGU) have been in an academic collaboration since 2016 to establish undergraduate healthcare programmes in Egypt with an underlying ethos of capacity building and co-development. We explored impacts of pandemic-related travel restrictions on staff across both organisations. Methods: We conducted 30 semi-structured interviews with academic and professional services staff from UCL and NGU schools of medicine, dentistry, and pharmacy. Data were jointly coded using reflexive thematic analysis and categorised according to the American Council on Education's Comprehensive Internationalisation Framework. Results: Nine themes were identified, which related to each of the six components of the framework. In addition to mobility, participants' experiences also spread across the other five components (institutional commitment, leadership, curriculum, faculty support, and partnerships). Successful adaptations were made and staff felt able to 'keep the show on the road'. However, staff remained keen to keep in-person engagement a priority when possible, especially for quality management site visits. Conclusions: Travel restrictions can have widespread impacts on all aspects of international collaborations. In this well-established relationship, there was sufficient resilience to withstand these impacts and, many positive unintended consequences emerged. A hybrid engagement model should be prioritised in future partnerships.

Intrafamilial transmission of hepatitis C infection in Egyptian multitransfused thalassemia patients.

OBJECTIVE: Detecting the current prevalence of hepatitis C virus (HCV) among Egyptian multitransfused thalassemic patients and evaluating the risk of its transmission within their family members. METHODS: Multitransfused Egyptian thalassemia patients (n = 137) were tested for HCV infection. Household contacts of positive members were compared with household contacts of HCV-negative patients. Antibodies to HCV were detected by enzyme immunoassay. Antibody-positive cases were retested for viral load using reverse transcriptase polymerase chain reaction. HCV genotyping was performed on positive samples of the patients and the positive household contacts. RESULTS: In all, 34.4% of patients (n = 47) were positive for HCV antibodies and RNA. The study of 24 families of HCV-positive patients showed 14 affected family members (19.2%). In 27 families of HCV-negative patients, four family members were affected (4.9%). HCV genotyping of seven families was similar in both patients and their family members. CONCLUSION: Our results support the role of intrafamilial transmission in the spread of HCV.

Breaking Borders: How Barriers to Global Mobility Hinder International Partnerships in Academic Medicine.

This article describes the authors' personal experiences of collaborating across international borders in academic research. International collaboration in academic medicine is one of the most important ways by which research and innovation develop globally. However, the intersections among colonialism, academic medicine, and global health research have created a neocolonial narrative that perpetuates inequalities in global health partnerships. The authors critically examine the visa process as an example of a racist practice to show how the challenges of blocked mobility increase inequality and thwart research endeavors. Visas are used to limit mobility across certain borders, and this limitation hinders international collaborations in academic medicine. The authors discuss the concept of social closure and how limits to global mobility for scholars from low- and middle-income countries perpetuate a cycle of dependence on scholars who have virtually barrier-free global mobility-these scholars being mainly from high-income countries. Given the current sociopolitical milieu of increasing border controls and fears of illegal immigration, the authors' experiences expose what is at stake for academic medicine when the political sphere, focused on tightening border security, and the medical realm, striving to build international research collaborations, intersect. Creating more equitable global partnerships in research requires a shift from the current paradigm that dominates most international partnerships and causes injury to African scholars.

Genotype-phenotype associations in familial Mediterranean fever: a study of 500 Egyptian pediatric patients.

INTRODUCTION: Familial Mediterranean fever (FMF) is the most prevalent monogenic autoinflammatory disease, caused by recessively inherited MEFV gene mutations. The most frequent MEFV mutations differ in penetrance and disease severity. We investigated the genotype-phenotype associations of the three most frequent MEFV gene mutations (M680I, M694V, and V726A) in Egyptian FMF children, regarding clinical features, severity, and colchicine response. METHODS: We conducted a retrospective analysis of the medical registries of 500 FMF pediatric patients from Metropolitan Cairo between 2010 and 2015. The diagnosis was based on the Tel-Hashomer clinical diagnostic criteria. Clinical data and baseline investigations were collected. Mutation analysis was performed by the amplification-refractory mutation system (ARMS)-PCR method. RESULTS: Males represented 54% and ages ranged from 2 to 18 years. The most frequent symptoms were abdominal pain, fever, and arthralgia. Clinical features mostly associated with M694V mutation either homozygous or heterozygous whether simple, double, or triple. Of the patients, 94.6% completely responded to colchicine. Among patients benefiting from colchicine, 42.5% had M694V/V726A, 21.6% had M694V/V726A/M680I, and 21.1% had M694V genotype. Simple heterozygous M694V or V726A mutations conveyed a moderate phenotype in 57.1% and 50% of cases, respectively. Homozygous M694V mutation showed moderate and severe phenotypes in 21.7% and 65.2% of cases, respectively. Compound M694V/V726A mutation associated with moderate or severe disease in 48.3% and 33.8% of cases, respectively. CONCLUSION: This study encompasses the largest group of Egyptian pediatric FMF up to date to explore their genotype-phenotype associations. Our results support the notion that the genotype influences the phenotype as regards clinical manifestations, disease severity, and colchicine response. KEY POINTS: • This study encompasses the largest group of Egyptian pediatric patients affected by FMF up to date to explore their genotype-phenotype associations. • Our results support the notion that the genotype influences the phenotype as regards the clinical manifestations, the disease severity, and the response to colchicine treatment.

The Best of Both Worlds: Experiences of Co-developing Innovative Undergraduate Health Care Programmes in Egypt.

As medical education has become increasingly globalised, universities across the world have sought to raise standards by partnering with well-established institutions and a number of different partnership models have emerged. This article describes an academic collaboration between University College London (UCL), UK, and Newgiza University (NGU), Egypt, to establish modern and innovative undergraduate medicine, dentistry, and pharmacy programmes delivered in Egypt. Academics from UCL and NGU co-developed programmes using established materials, assessments, and processes from the equivalent programmes at UCL. Dedicated project managers, regular steering group meetings, strong working relationships between project teams, and iterative curriculum and assessment development processes were important features of the success of this work. A multidisciplinary first semester included students across all 3 health care programmes. This promoted collaboration between academics at both institutions. Although UCL resources were the basis of this project, the different sociocultural, ethical, professional, and regulatory frameworks in Egypt have meant that a number of adaptations have been necessary, in both curricula and teaching content. Perhaps the most important factor underpinning the success of this project has been the mutual respect and sensitivity of academics and clinicians from both institutions.

Blood transfusion among thalassemia patients: A single Egyptian center experience.

BACKGROUND: Although red cell transfusions are lifesavers for patients with thalassemia, they are responsible for a series of complications and expose the patients to a variety of risks. MATERIAL AND METHODS: This cross-sectional study included 464 Egyptian beta(ß) thalassemia major patients whose age ranged between 10 months and 31 years (mean 10.2 ± 6.6 years). All patients were subjected to thorough history taking with special emphasis on blood transfusions regarding rate of blood transfusion, type of received blood, and history of previous transfusion reactions in addition to type of chelation and compliance to iron chelation therapy and history of diabetes. Serum ferritin and pretransfusion hemoglobin assessment were done for all patients. RESULTS: The mean pretransfusion hemoglobin level was 5.7 ± 1.16 g/dl. Allergic reactions were observed in 3.9% of the patients during the period of the study, while the history of previous allergic reaction was given by 72% of the patients. Deferiprone showed better compliance (58.6%) than deferoxamine (26.3%). The prevalence of diabetes was 10.1% among the studied group. On comparing diabetics to nondiabetics, serum ferritin, transfusion intervals, and age were statistically higher among diabetics (P<0.001). CONCLUSION: Lower pretransfusion hemoglobin and high rate of prevalence of diabetes, in addition to better compliance to deferiprone than deferoxamine, were detected among the patients.

Improvement of cardiac function in thalassemia major treated with L-carnitine.

INTRODUCTION: Heart disease secondary to chronic anemia and hemosiderosis remains the major cause of morbidity and mortality in thalassemic patients. Chronic anemia and the tissue hypoxia it induces impair free fatty acid oxidation and ATP production in myocardial cells. The use of L-carnitine, a butyric acid derivative, may help overcome some of these defects. OBJECTIVE: To investigate the effect of L-carnitine therapy on cardiac function in thalassemia major patients. MATERIALS AND METHODS: Cardiac function was evaluated in 30 patients attending our clinic. The mean (+/-SD) age was 15.87 +/- 3.19 years. The studies we performed included echocardiography, Doppler and multigated equilibrium radionuclide angiography (MUGA). Systolic and diastolic function was evaluated before starting L-carnitine treatment and after 6 months of oral L-carnitine (50 mg/kg/day). RESULTS: Echocardiography studies revealed no significant changes in systolic and diastolic function after L-carnitine therapy (p > 0.05). Analysis of the data taken by MUGA performed in 20 of the patients, however, showed a significant improvement of diastolic function after 6 months of L-carnitine therapy. The mean peak filling rate (end-diastolic volume/s) increased from 3.15 +/- 1.06 to 3.61 +/- 1.68 (p < 0.03). The time to peak (during filling) decreased significantly from 143.45 +/- 42.04 to 117.70 +/- 24.40 s (p < 0.02). Systolic function showed a significant increase in the left ventricular ejection fraction from 58.25 +/- 9.92 to 63.95 +/- 10.11% (p = 0.0001). CONCLUSION: L-carnitine may be an effective drug for improving the cardiac status of thalassemic patients. MUGA is the most accurate technique of those used here for assessing left ventricular function in these patients.