Medical educators are in a continuous quest to close the gap between the needs of medical practic... more 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 sta...
Additional file of Ethical and procedural issues for applying researcher-driven multi-national pa... more Additional file of 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: Although the risk of transfusion-transmitted hepatitis has been recently reduced, tra... more Background: Although the risk of transfusion-transmitted hepatitis has been recently reduced, transfusion-dependent β-thalassemia patients are still at a high risk of hepatitis B virus (HBV) and hepatitis C virus (HCV) infection. We aimed to look into the prevalence of HBV and HCV sero-positivity amongst multiply transfused thalassemia patients at our center. Patients and Methods: Four hundred and thirty five thalassemic patients (mean age 10.1±6.7 years) were recruited to participate in this study. The records of patients were reviewed and history was taken with emphasis on blood transfusion. Blood samples were withdrawn and tested for hepatitis B surface antigen (HBsAg) using Qualitative chemiluminescent immunoassay (ChLIA), anti-HCV antibodies using third generation ELISA kits in addition to serum ferritin and pre-transfusion hemoglobin. Results: Ninety-five/406 (23.4%) patients were infected by HBV and their mean age was significantly higher than HBV sero-negative patients. A si...
We evaluated the ability of serum transferrin receptor [sTFR] to identify different types of anae... more We evaluated the ability of serum transferrin receptor [sTFR] to identify different types of anaemia in children. Thus 150 Egyptian children suffering from anaemia [iron deficiency anaemia, anaemia of chronic disease and beta-thalassaemia] were enrolled, together with 50 controls. There was a significant increase in the mean levels of sTFR in the groups with iron deficiency anaemia and thalassaemia, and a significant decrease in mean sTFR levels in the group with anaemia of chronic disease. Serum ferritin levels were significantly higher in all patient groups except the group with iron deficiency anaemia. There were also significant correlations between the sTFR and sTFR/log ferritin ratio [sTFR-F index] and different indices of iron status and of erythropoiesis. The sTFR-F index could be used as a diagnostic or screening tool for iron deficiency anaemia, anaemia of chronic disease and thalassaemia.
In Gaucher disease, the infiltration of the bone marrow by glucocerebroside-laden macrophages (Ga... more In Gaucher disease, the infiltration of the bone marrow by glucocerebroside-laden macrophages (Gaucher cells) triggers a diverse pattern of skeletal disease that results in crippling complications. Reliable ascertainment of the severity and pattern of skeletal disease is essential to determine disease status and the response to enzyme replacement therapy (ERT). Although there is ample documentation of reversal of haematological and visceral disease by ERT, there is a paucity of data on skeletal response to ERT in children. To delineate the pattern of bone disease in children with Gaucher disease in Egypt and to evaluate its response to ERT. Twenty-two children with Gaucher disease were treated with ERT. Phenotyping by clinical, laboratory and radiological criteria was performed at baseline and following 11.2 +/- 4 months of ERT. Genotyping for glucocerebrosidase (GBA) mutations was performed by gene sequencing, and genotype-phenotype correlations were performed.Results. Two-thirds of the patients were from consanguineous pedigrees and 14/22 patients were homozygous or compound heterozygous for L444P and D409H mutations. Bone involvement was detected by plain radiology in 11 children (50%) and in 16 (73%) by magnetic resonance imaging (MRI). There was no correlation of severity of bone involvement and GBA genotype. ERT ameliorated bone disease: 10 of the 11 children with abnormal radiographic findings at baseline showed improvement in skeletal lesions; while 9/16 showed improvement of marrow disease by MRI. Radiographic sensitivity and specificity were 62% and 82% compared to MRI for detection of bone involvement in this patient population. At baseline, bone pain was present in 5 patients and ERT resulted in complete symptomatic remission in all of them. ERT was associated with significant improvement in growth parameters and amelioration of haematological and visceral involvement. Symptomatic and radiological skeletal disease is common in children with Gaucher disease in Egypt. MRI is the most accurate technique for detecting early skeletal involvement. There was no correlation between severity of skeletal involvement and GBA genotype. ERT was effective in ameliorating radiological manifestations of skeletal disease and achieving complete remission of bone pain.
The Journal of the Egyptian Public Health Association, 1990
Fifty seven Egyptian children aged 1.5 to 9.5 years with mild splenomegaly (less than 3 cm below ... more Fifty seven Egyptian children aged 1.5 to 9.5 years with mild splenomegaly (less than 3 cm below the costal margin) were screened for antibodies against the three common viruses of the Herpes group: Cytomegalovirus (CMV), Epstein-Barr (EB) and Herpes type 1 virus. A group of 57 healthy children were studied similarly. All patients were subjected to a comprehensive laboratory and clinical work up to exclude any hematological, metabolic or malignant etiology for the splenomegaly. Splenic aspirates from five cases were examined histologically and by immunohistochemistry for the antigens of CMV. Only primary or reactivation of CMV might be considered a cause of splenomegaly, as there was a statistically significant increase in the prevalence of IgM antibodies to CMV in the patients compared to normal controls (63% of patients and 19.4% of controls had IgM antibodies, P less than 0.001; 68.3% of patients and 54% of controls had IgG antibodies, P is insignificant). An almost equal proport...
Background We describe our experience from a multi-national application of a European Union-funde... more 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 m...
Journal of Medical Education and Curricular Development
As medical education has become increasingly globalised, universities across the world have sough... more 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 institut...
Heart disease secondary to chronic anemia and hemosiderosis remains the major cause of morbidity ... more 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. To investigate the effect of L-carnitine therapy on cardiac function in thalassemia major patients. 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). 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). 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.
Detecting the current prevalence of hepatitis C virus (HCV) among Egyptian multitransfused thalas... more 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. 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. 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. Our results supp...
Medical educators are in a continuous quest to close the gap between the needs of medical practic... more 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 sta...
Additional file of Ethical and procedural issues for applying researcher-driven multi-national pa... more Additional file of 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: Although the risk of transfusion-transmitted hepatitis has been recently reduced, tra... more Background: Although the risk of transfusion-transmitted hepatitis has been recently reduced, transfusion-dependent β-thalassemia patients are still at a high risk of hepatitis B virus (HBV) and hepatitis C virus (HCV) infection. We aimed to look into the prevalence of HBV and HCV sero-positivity amongst multiply transfused thalassemia patients at our center. Patients and Methods: Four hundred and thirty five thalassemic patients (mean age 10.1±6.7 years) were recruited to participate in this study. The records of patients were reviewed and history was taken with emphasis on blood transfusion. Blood samples were withdrawn and tested for hepatitis B surface antigen (HBsAg) using Qualitative chemiluminescent immunoassay (ChLIA), anti-HCV antibodies using third generation ELISA kits in addition to serum ferritin and pre-transfusion hemoglobin. Results: Ninety-five/406 (23.4%) patients were infected by HBV and their mean age was significantly higher than HBV sero-negative patients. A si...
We evaluated the ability of serum transferrin receptor [sTFR] to identify different types of anae... more We evaluated the ability of serum transferrin receptor [sTFR] to identify different types of anaemia in children. Thus 150 Egyptian children suffering from anaemia [iron deficiency anaemia, anaemia of chronic disease and beta-thalassaemia] were enrolled, together with 50 controls. There was a significant increase in the mean levels of sTFR in the groups with iron deficiency anaemia and thalassaemia, and a significant decrease in mean sTFR levels in the group with anaemia of chronic disease. Serum ferritin levels were significantly higher in all patient groups except the group with iron deficiency anaemia. There were also significant correlations between the sTFR and sTFR/log ferritin ratio [sTFR-F index] and different indices of iron status and of erythropoiesis. The sTFR-F index could be used as a diagnostic or screening tool for iron deficiency anaemia, anaemia of chronic disease and thalassaemia.
In Gaucher disease, the infiltration of the bone marrow by glucocerebroside-laden macrophages (Ga... more In Gaucher disease, the infiltration of the bone marrow by glucocerebroside-laden macrophages (Gaucher cells) triggers a diverse pattern of skeletal disease that results in crippling complications. Reliable ascertainment of the severity and pattern of skeletal disease is essential to determine disease status and the response to enzyme replacement therapy (ERT). Although there is ample documentation of reversal of haematological and visceral disease by ERT, there is a paucity of data on skeletal response to ERT in children. To delineate the pattern of bone disease in children with Gaucher disease in Egypt and to evaluate its response to ERT. Twenty-two children with Gaucher disease were treated with ERT. Phenotyping by clinical, laboratory and radiological criteria was performed at baseline and following 11.2 +/- 4 months of ERT. Genotyping for glucocerebrosidase (GBA) mutations was performed by gene sequencing, and genotype-phenotype correlations were performed.Results. Two-thirds of the patients were from consanguineous pedigrees and 14/22 patients were homozygous or compound heterozygous for L444P and D409H mutations. Bone involvement was detected by plain radiology in 11 children (50%) and in 16 (73%) by magnetic resonance imaging (MRI). There was no correlation of severity of bone involvement and GBA genotype. ERT ameliorated bone disease: 10 of the 11 children with abnormal radiographic findings at baseline showed improvement in skeletal lesions; while 9/16 showed improvement of marrow disease by MRI. Radiographic sensitivity and specificity were 62% and 82% compared to MRI for detection of bone involvement in this patient population. At baseline, bone pain was present in 5 patients and ERT resulted in complete symptomatic remission in all of them. ERT was associated with significant improvement in growth parameters and amelioration of haematological and visceral involvement. Symptomatic and radiological skeletal disease is common in children with Gaucher disease in Egypt. MRI is the most accurate technique for detecting early skeletal involvement. There was no correlation between severity of skeletal involvement and GBA genotype. ERT was effective in ameliorating radiological manifestations of skeletal disease and achieving complete remission of bone pain.
The Journal of the Egyptian Public Health Association, 1990
Fifty seven Egyptian children aged 1.5 to 9.5 years with mild splenomegaly (less than 3 cm below ... more Fifty seven Egyptian children aged 1.5 to 9.5 years with mild splenomegaly (less than 3 cm below the costal margin) were screened for antibodies against the three common viruses of the Herpes group: Cytomegalovirus (CMV), Epstein-Barr (EB) and Herpes type 1 virus. A group of 57 healthy children were studied similarly. All patients were subjected to a comprehensive laboratory and clinical work up to exclude any hematological, metabolic or malignant etiology for the splenomegaly. Splenic aspirates from five cases were examined histologically and by immunohistochemistry for the antigens of CMV. Only primary or reactivation of CMV might be considered a cause of splenomegaly, as there was a statistically significant increase in the prevalence of IgM antibodies to CMV in the patients compared to normal controls (63% of patients and 19.4% of controls had IgM antibodies, P less than 0.001; 68.3% of patients and 54% of controls had IgG antibodies, P is insignificant). An almost equal proport...
Background We describe our experience from a multi-national application of a European Union-funde... more 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 m...
Journal of Medical Education and Curricular Development
As medical education has become increasingly globalised, universities across the world have sough... more 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 institut...
Heart disease secondary to chronic anemia and hemosiderosis remains the major cause of morbidity ... more 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. To investigate the effect of L-carnitine therapy on cardiac function in thalassemia major patients. 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). 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). 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.
Detecting the current prevalence of hepatitis C virus (HCV) among Egyptian multitransfused thalas... more 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. 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. 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. Our results supp...
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