The Prevalence of Active Epilepsy in the Kingdom of Saudi Arabia: A Cross-Sectional Study.

INTRODUCTION: The global prevalence of active epilepsy is around 6.38/1,000 persons. In the Arabian region, the median prevalence of active epilepsy is 4.4/1,000 persons. In the Kingdom of Saudi Arabia (KSA), the last prevalence study for active epilepsy cases was conducted in 2001 and showed an estimate of 6.5/1,000 persons. OBJECTIVES: The aim of the study was to investigate the prevalence of active epilepsy and etiological factors among Saudi individuals of all ages resident in the Riyadh area, the central province, and the capital of KSA. METHOD: This is a door-to-door cross-sectional epidemiological study that was conducted between 2012 and 2016. Patients were initially screened at their homes using a questionnaire, and then suspected individuals were interviewed in the clinic by neurologists and epileptologists. Data related to age, age at seizure onset, gender, probable etiology, treatment, family history, duration of epilepsy, and seizure control, as well as images for electroencephalogram and magnetic resonant imaging, were collected and analyzed. RESULTS: Among the 13,873 participants, active epilepsy was evidenced in 55 patients (3.96; 95% CI: [2.99-5.16]/1,000 persons). No significant variation in the prevalence rate was detected between male and female patients (3.99 vs. 3.94/1,000 persons). The age-specific prevalence was the highest among the infants (1-12 months) (14.78/1,000 persons). Of the various seizure types, complex partial seizures were the most common (33%), followed by generalized seizures (29.1%). Concerning etiology, epilepsies with idiopathic and cryptogenic etiologies were the most common in 18 (36.3%) cases. Structural, vascular, and focal abnormalities were the most commonly diagnosed abnormalities (18.2%, 14.5%, and 39.2%, respectively). CONCLUSION: The prevalence of active epilepsy in KSA has dramatically decreased during the last decades to a rate lower than those reported in most developing countries.

Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial.

PURPOSE: Despite evidence of myocardial infarct size reduction in animal studies, remote ischaemic conditioning (RIC) failed to improve clinical outcomes in the large CONDI-2/ERIC-PPCI trial. Potential reasons include that the predominantly low-risk study participants all received timely optimal reperfusion therapy by primary percutaneous coronary intervention (PPCI). Whether RIC can improve clinical outcomes in higher-risk STEMI patients in environments with poor access to early reperfusion or PPCI will be investigated in the RIC-AFRICA trial. METHODS: The RIC-AFRICA study is a sub-Saharan African multi-centre, randomized, double-blind, sham-controlled clinical trial designed to test the impact of RIC on the composite endpoint of 30-day mortality and heart failure in 1200 adult STEMI patients without access to PPCI. Randomized participants will be stratified by whether or not they receive thrombolytic therapy within 12 h or arrive outside the thrombolytic window (12-24 h). Participants will receive either RIC (four 5-min cycles of inflation [20 mmHg above systolic blood pressure] and deflation of an automated blood pressure cuff placed on the upper arm) or sham control (similar protocol but with low-pressure inflation of 20 mmHg and deflation) within 1 h of thrombolysis and applied daily for the next 2 days. STEMI patients arriving greater than 24 h after chest pain but within 72 h will be recruited to participate in a concurrently running independent observational arm. CONCLUSION: The RIC-AFRICA trial will determine whether RIC can reduce rates of death and heart failure in higher-risk sub-optimally reperfused STEMI patients, thereby providing a low-cost, non-invasive therapy for improving health outcomes.

Comparison of Dual Therapies for Lowering Blood Pressure in Black Africans.

BACKGROUND: The prevalence of hypertension among black African patients is high, and these patients usually need two or more medications for blood-pressure control. However, the most effective two-drug combination that is currently available for blood-pressure control in these patients has not been established. METHODS: In this randomized, single-blind, three-group trial conducted in six countries in sub-Saharan Africa, we randomly assigned 728 black patients with uncontrolled hypertension (≥140/90 mm Hg while the patient was not being treated or was taking only one antihypertensive drug) to receive a daily regimen of 5 mg of amlodipine plus 12.5 mg of hydrochlorothiazide, 5 mg of amlodipine plus 4 mg of perindopril, or 4 mg of perindopril plus 12.5 mg of hydrochlorothiazide for 2 months. Doses were then doubled (10 and 25 mg, 10 and 8 mg, and 8 and 25 mg, respectively) for an additional 4 months. The primary end point was the change in the 24-hour ambulatory systolic blood pressure between baseline and 6 months. RESULTS: The mean age of the patients was 51 years, and 63% were women. Among the 621 patients who underwent 24-hour blood-pressure monitoring at baseline and at 6 months, those receiving amlodipine plus hydrochlorothiazide and those receiving amlodipine plus perindopril had a lower 24-hour ambulatory systolic blood pressure than those receiving perindopril plus hydrochlorothiazide (between-group difference in the change from baseline, -3.14 mm Hg; 95% confidence interval [CI], -5.90 to -0.38; P = 0.03; and -3.00 mm Hg; 95% CI, -5.8 to -0.20; P = 0.04, respectively). The difference between the group receiving amlodipine plus hydrochlorothiazide and the group receiving amlodipine plus perindopril was -0.14 mm Hg (95% CI, -2.90 to 2.61; P=0.92). Similar differential effects on office and ambulatory diastolic blood pressures, along with blood-pressure control and response rates, were apparent among the three groups. CONCLUSIONS: These findings suggest that in black patients in sub-Saharan Africa, amlodipine plus either hydrochlorothiazide or perindopril was more effective than perindopril plus hydrochlorothiazide at lowering blood pressure at 6 months. (Funded by GlaxoSmithKline Africa Noncommunicable Disease Open Lab; CREOLE ClinicalTrials.gov number, NCT02742467.).

Patterns of adverse drug reactions (ADRs) in Saudi Arabia.

BACKGROUND: Pharmacovigilance enhances post-market drug safety. However, analytical reports of a pattern of adverse drug reactions (ADRs) experienced by patients in Saudi Arabia are demanded. OBJECTIVE: To describe patterns of ADRs submitted to the Saudi Central National Pharmacovigilance and Drug Safety Center (NPC), Saudi Food and Drug Administration (SFDA), from its inception in 2015 until the end of 2017 to understand the pattern of ADR reporting in Saudi Arabia. METHODS: In this retrospective study, data from cases reported to the NPC were used to determine ADRs and identify the most common associated drug classes based on anatomical therapeutic chemical (ATC) classification system. RESULT: A total of 17,730 ADR cases were reported during study period. An annual increase in ADRs was clearly evident. Approximately 54% of the total ADRs reported were serious. Most commonly reported ATC drug classes were anti-infective agents for systemic use (22.27%), antineoplastic and immunomodulating agents (21.49%), alimentary tract and metabolism (15.48 %), cardiovascular system (11.11%) and nervous system (10.23%). Vancomycin (2.7%), ceftiraxone (1.8%), fingolimod (1.4%) and paracetamol (1.4%) were the most common drugs associated with serious ADRs. CONCLUSION: This study provide valuable insights in hypothesis generation for future studies on drug-event interactions and amplification studies. The NPC educational programs and awareness campaigns to promote systematic reporting of ADRs among healthcare professionals and general public should be continued.

Quality of life among home healthcare patients in Saudi Arabia: household-based survey.

BACKGROUND: The need for home healthcare programs is an increasingly becoming important common component of healthcare worldwide, as an alternative to hospitalization, owing to the growing elderly population, chronic and acute diseases that need continuous monitoring and care. The overall aim of this study was to describe and assess the quality of life (QOL) and associated determinants among patients enrolled in the Home Health Care (HHC) program affiliated with the Ministry of National Guard Health Affairs in Riyadh, Saudi Arabia. METHODS: This cross-sectional study was conducted among patients enrolled at the HHC program. The World Health Organization QOL questionnaire (WHOQOL-BREF) was used to collect data about the different domains of patients' QOL. Logistic regression models were fitted to determine factors associated with QOL low score. RESULTS: The study included 253 patients. Mean age was 67.05 (± 20.0). The overall QOL for HHC patients was significantly affected by both socio-demographic and morbid characteristics. In the final Multivariate logistic regression models, marital status, and having psychological problems, stroke and number illness were independently associated with the overall QOL of HHC patients (p = .022, p = .002, p = .031, .057 respectively). The physical health domain score was significantly associated with education level, having psychological problems and stroke (p = .028, p = .002, p = .007 retrospectively) whereas the psychological domain score was significantly associated with age (p = < 0.001) and three types of chronic diseases: pulmonary (p = .002), psychological problems (p = < 0.001). The social domain score was significantly associated only with the marital status (p = .026). The environmental domain was significantly associated with the education level and having stroke (p = .017 vs .027). CONCLUSIONS: The overall QOL and its domains are significantly associated with several different factors. Many of these factors can be monitored and enhanced by improving quality of HHC services, thus improving the QOL of patients.

An assessment for diagnostic and therapeutic modalities for management of pediatric Iron defficiency Anemia in Saudi Arabia: a crossectional study.

INTRODUCTION: Iron deficiency anemia (IDA) is a global public health issue that affect more than 2 billion individuals worldwide. However evidence for optimal management of IDA is lacking. METHODS: To assess the diagnostic criteria and therapeutic modalities for pediatric IDA employed by physicians in a major public healthcare facility in Riyadh, a validated questionnaire including demographic data and patient case-scenarios related to diagnosis and treatment of IDA was employed. Robust regression analysis was used to identify factors associated with overall score of participants. RESULTS: Of the 166 physicians surveyed 147(88.6%) were included in the study. Wide variability was observed in IDA diagnosis and therapy practises. For nutritional IDA, only 15.6% recommended no other laboratory tests in addition to CBC. The majority preferred treatment with ferrous sulfate (77.6%) divided into two doses (57.1%), but the total daily elemental iron doses varied widely from 2 to 6 mg/kg. For intravenous iron, 42.9% recommended iron dextran, 32.7% iron sucrose, and 13.4% would continue oral iron. Of all assessed factors, median score was significantly highest in pediatric hematologists compared with pediatricians, family medicine specialists and GPs; p = 0.007, and those work in tertiary care compared with those in primary care; p = 0.043. However, in multivariate robust regression analysis, overall score was only significantly associated with professional qualification [pediatric hematologist ß = 13.71,95%CI 2.48-24.95, p = 0.017; pediatrician ß = 1.77,95%C (- 6.05-9.59, p = 0.66; family medicine ß = 2.66,95%CI-4.30-9.58, p = 0.45 compared with general practitioner]. CONCLUSION: Wide variations exist among physicians in diagnosis and treatment of pediatric IDA. Intervention programs and national guidelines are urgently needed.

Rationale and design of the comparison of 3 combination therapies in lowering blood pressure in black Africans (CREOLE study): 2 × 3 factorial randomized single-blind multicenter trial.

BACKGROUND: Current hypertension guidelines recommend the use of combination therapy as first-line treatment or early in the management of hypertensive patients. Although there are many possible combinations of blood pressure(BP)-lowering therapies, the best combination for the black population is still a subject of debate because no large randomized controlled trials have been conducted in this group to compare the efficacy of different combination therapies to address this issue. METHODS: The comparison of 3 combination therapies in lowering BP in the black Africans (CREOLE) study is a randomized single-blind trial that will compare the efficacy of amlodipine plus hydrochlorothiazide versus amlodipine plus perindopril and versus perindopril plus hydrochlorothiazide in blacks residing in sub-Saharan Africa (SSA). Seven hundred two patients aged 30-79 years with a sitting systolic BP of 140 mm Hg and above, and less than 160 mm Hg on antihypertensive monotherapy, or sitting systolic BP of 150 mm Hg and above, and less than 180 mm Hg on no treatment, will be centrally randomized into any of the 3 arms (234 into each arm). The CREOLE study is taking place in 10 sites in SSA, and the primary outcome measure is change in ambulatory systolic BP from baseline to 6 months. The first patient was randomized in June 2017, and the trial will be concluded by 2019. CONCLUSIONS: The CREOLE trial will provide unique information as to the most efficacious 2-drug combination in blacks residing in SSA and thereby inform the development of clinical guidelines for the treatment of hypertension in this subregion.

Risk factors for falls in older adults in a South African Urban Community.

BACKGROUND: Studies on falls in older adults have mainly been conducted in high income countries. Scant, if any, information exists on risk factors for falls in the older population of sub-Saharan African countries. METHODS: A cross-sectional survey and a 12-month follow-up study were conducted to determine risk factors for falls in a representative multi-ethnic sample of 837 randomly selected ambulant community-dwelling subjects aged ≥65 years in three suburbs of Cape Town, South Africa. Logistic regression models were fitted to determine the association between (1) falls and (2) recurrent falls occurring during follow-up and their potential socio-demographic, self-reported medical conditions and physical assessment predictors. RESULTS: Prevalence rates of 26.4 % for falls and 11 % for recurrent falls at baseline and 21.9 % for falls and 6.3 % for recurrent falls during follow-up. In both prospective analyses of falls and recurrent falls, history of previous falls, dizziness/vertigo, ethnicity (white or mixed ancestry vs black African) were significant predictors. However, poor cognitive score was a significant predictor in the falls analysis, and marital status (unmarried vs married) and increased time to perform the timed Up and Go test in the recurrent fall analysis but not in both. Other than the timed Up and Go test in recurrent falls analysis, physical assessment test outcomes were not significant predictors of falls. CONCLUSION: Our study provides simple criteria based on demographic characteristics, medical and physical assessments to identify older persons at increased risk of falls. History taking remains an important part of medical practice in the determination of a risk of falls in older patients. Physical assessment using tools validated in developed country populations may not produce results needed to predict a risk of falls in a different setting.

Long-term outcomes of patients with extensively drug-resistant tuberculosis in South Africa: a cohort study.

BACKGROUND: Long-term treatment-related outcomes in patients with extensively drug-resistant (XDR) tuberculosis are unknown. We followed up a cohort of patients to address knowledge gaps. METHODS: Between March, 2008, and August, 2012, we prospectively followed up a cohort of 107 patients from three provinces in South Africa, who had been diagnosed with XDR tuberculosis between August 2002, and February, 2008. Available isolates from 56 patients were genotyped to establish strain type and used for extended susceptibility testing. FINDINGS: All patients were treated empirically as inpatients with a median of eight drugs (IQR six to ten). 44 patients (41%) had HIV. 36 (64%) of 56 isolates were resistant to at least eight drugs, and resistance to an increasing number of drugs was associated with the Beijing genotype (p=0·01). After 24 months of follow-up, 17 patients (16%) had a favourable outcome (ie, treatment cure or completion), 49 (46%) had died, seven (7%) had defaulted (interruption of treatment for at least 2 consecutive months), and 25 (23%) had failed treatment. At 60 months, 12 patients (11%) had a favourable outcome, 78 (73%) had died, four (4%) had defaulted, and 11 (10%) had failed treatment. 45 patients were discharged from hospital, of whom 26 (58%) had achieved sputum culture conversion and 19 (42%) had failed treatment. Median survival of patients who had failed treatment from time of discharge was 19·84 months (IQR 4·16-26·04). Clustering of cases and transmission within families containing a patient who had failed treatment and been discharged were shown with genotypic methods. Net sputum culture conversion occurred in 22 patients (21%) and median time to net culture conversion was 8·7 months (IQR 5·6-26·4). Independent predictors of probability of net culture conversion were no history of multidrug-resistant tuberculosis (p=0·0007) and use of clofazamine (p=0·0069). Independent overall predictors of survival were net culture conversion (p<0·0001) and treatment with clofazamine (p=0·021). Antiretroviral therapy was also a predictor of survival in patients with HIV (p=0·003). INTERPRETATION: In South Africa, long-term outcomes in patients with XDR tuberculosis are poor, irrespective of HIV status. Because appropriate long-stay or palliative care facilities are scarce, substantial numbers of patients with XDR tuberculosis who have failed treatment and have positive sputum cultures are being discharged from hospital and are likely to transmit disease into the wider community. Testing of new combined regimens is needed urgently and policy makers should implement interventions to minimise disease spread by patients who fail treatment. FUNDING: European and Developing Countries Clinical Trials Partnership, South African National Research Foundation (SARChI), and the South African Medical Research Council.

A 23 years audit of packed red blood cell consumption in a university hospital in a developing country.

BACKGROUND: There is paucity of information on the blood transfusion practice in developing countries. The current audit aims to find out the long term trend in the consumption of packed red blood cells (PRBCs) in a large Saudi teaching hospital in Riyadh MATERIALS AND METHODS: We analyzed the annual consumption of PRBCs from 1985 to 2007 in seven major hospital divisions (Medicine, General Surgery, Pediatrics, Obstetrics and Gynecology, Cardiac Surgery, Accident and Emergency and Renal Dialysis Unit) at the 850-bed King Khalid University Hospital (KKUH), Riyadh. RESULTS: Grand total consumption of PRBCs was 345,642 units. The consumption increased gradually and peaked in the year 1994, dropped to 30.4% 6 years later and then increased gradually thereafter, due to the expansion in the number of patients cared for in the Departments of Medicine, Cardiac Surgery and Accident and Emergency, while in the Department of Pediatrics the drop in consumption continued unabated. In the Renal Dialysis Unit consumption was minimal with the use of erythropoietin therapy. The crossmatch:transfusion ratio uncovered gross over-ordering of PRBCs and wastage of blood bank resources in most hospital divisions most notably in the Department of Obstetrics and Gynecology. CONCLUSION: The results obtained indicate clearly that there has been overuse of blood products that dropped markedly in years coinciding with the worldwide apprehension about the safety of transfusion therapy particularly HIV transmission. This factor in addition to the current implementation of strict guidelines is gradually improving transfusion practices in our institute.

Problem-based learning in undergraduate medical education in Saudi Arabia: time has come to reflect on the experience.

BACKGROUND: Problem-based learning (PBL) is being increasingly used in many undergraduate medical schools worldwide due to its recognized advantages. OBJECTIVES: To explore views of medical students in the Kingdom of Saudi Arabia (KSA) about the appropriateness of the PBL concepts and process. Differences in students' views were examined as well. METHODS: This is a cross-sectional, questionnaire-based study conducted in two medical colleges in Riyadh, Saudi Arabia, during the period from April to June 2012. RESULTS: One hundred seventy four undergraduate medical students participated in the study. Majority of the participants supported the concept of PBL and thought it is a beneficial learning strategy. However, only about half of them consider the problems used in tutorials are relevant for the local setting. Significant differences have been identified between the gender, schools, and study level of participants and their views on the process of PBL tutorials. About 35% of participants either undecided or will not recommend medical schools that adopt PBL curriculums for their friends. CONCLUSIONS: The majority of participants were satisfied with PBL approach and valued its importance in their learning process. Specific concerns have been expressed about relevance of some aspects of PBL. Underlying factors should be further explored in order to improve the outcomes of PBL curriculum in the local Saudi setting.

Effect of course coordinator behavior and motivation on students' achievement: Results from five curriculum blocks of two undergraduate student cohorts at King Saud bin Abdulaziz University of Health Sciences.

OBJECTIVE: The purpose of the study was to assess the relationship between students' perception of course/block coordinators performance and attributes with students' assessment scores in respective courses. METHODS: This retrospective data based study was conducted at the College of Medicine, King Saud bin Abdulaziz University of Health Sciences (KSAU-HS). It was started in March 2013 and completed in June 2013 after the graduation of the fourth cohort. Exam score of 3(rd) and 4(th) cohort of students from the courses taught in the last two years of medical school were correlated with faculty and block evaluation done by the students. Scores from mid-block MCQs, portfolio scores, OSCEs and end-of-block MCQs were obtained. RESULTS: The Mean scores of all the assessments for all five blocks were not significantly different for both batches. There was significant difference between block coordinators for students' score on portfolio, midterm exam and the final written exam. The students' Score in OSCE had significantly strong correlation with quality of station monitors, coverage of content and flow between stations. Student's perception of the commitment and motivation of the coordinator was strongly correlated with block organization, availability of clinical cases, performance of block coordinator, cooperation with students, and organization of clinical activities. CONCLUSIONS: Block coordinator's motivation and commitment affects quality of block organization and student`s success. Faculty training programs should include block management competencies and components identified through self-determination theory for improving the intrinsic motivation for students success.

Retinopathy risk factors in patients with type 2 diabetes on liraglutide.

Liraglutide, a glucagon-like peptide 1 receptor agonist, effectively treats type 2 diabetes(T2D) by lowering glucose levels, suppressing glucagon release, and promoting insulin secretion. Liraglutide has been shown to reduce body weight and glycated hemoglobin (HbA1c) levels and improve cardiovascular outcomes. However, evidence regarding the association between liraglutide and diabetic retinopathy in the Middle East is insufficient. Therefore, this study aimed to investigate the characteristics and risk factors of diabetic retinopathy in patients with T2D treated with liraglutide in Saudi Arabia. This retrospective cohort study was conducted on patients (≥14 years) with T2D treated with liraglutide between 2015 and 2021, who had a documented retinopathy assessment at baseline before liraglutide initiation and during follow-up, at King Abdulaziz Medical City (KAMC), Riyadh. Data collection included demographic information, retinopathy status, body mass index (BMI), and HbA1c level at baseline and follow-up after liraglutide use. The study included 181 patients with a mean age of 58.2 (9.8) years. Of these, 72.9% were females. At baseline, the median weight (interquartile range) was 88 (77-100) kg, diabetes duration was 19 (13-23.5) years, and HbA1c level was 9% (8-10%). Total of 69.6% were on insulin, 22.7% were on oral hypoglycemic agents, and 7.7% were on no other medications in addition to liraglutide. After a median of 2 years follow-up, both HbA1c level and weight decreased significantly (P < .001). Seventy-one of the 87 patients (81.6%) without retinopathy at baseline continued to show no retinopathy. Among patients with retinopathy at baseline, 25.5% showed improvement and 44.7% showed no change. In the multivariate binary mixed effect analysis, factors significantly associated with retinopathy were: use of insulin (odds ratio [OR]:2.68; 95% confidence interval [CI]: 1.18-6.09, P = .019), older age (OR:1.03; 95% CI: 1.00-1.06; P = .022), higher HbA1c level (OR:1.17; 95% CI: 1.02-1.34; P = .024), Hypertension (OR:2.56; 95% CI: 1.13-5.76; P=<.0001) and longer diabetes duration (OR:1.04; 95% CI: 1.00-1.08; P = .024). In conclusion, liraglutide use caused significant reductions in the HbA1c level and weight of patients with T2D. Most patients showed no change in retinopathy status after liraglutide use.

Novel point mutations and mutational complexes in the enhancer II, core promoter and precore regions of hepatitis B virus genotype D1 associated with hepatocellular carcinoma in Saudi Arabia.

In this study, a cohort of 182 patients [55 hepatocellular carcinoma (HCC) and 127 non-HCC] infected with hepatitis B virus (HBV) in Saudi Arabia was investigated to study the relationship between sequence variation in the enhancer II (EnhII), basal core promoter (BCP) and precore regions of HBV genotype D (HBV/D) and the risk of HCC. HBV genotypes were determined by sequencing analysis and/or enzyme-linked immunosorbent assay. Variations in the EnhII, BCP and precore regions were compared between 107 non-HCC and 45 HCC patients infected with HBV/D, followed by age-matched analysis of 40 cases versus equal number of controls. Age and male gender were significantly associated with HCC (p = 0.0001 and p = 0.03, respectively). Serological markers such as aspartate aminotransferase, albumin and anti-HBe were significantly associated with HCC (p = 0.0001 for all), whereas HBeAg positivity was associated with non-HCC (p = 0.0001). The most prevalent HBV genotype was HBV/D (94%), followed by HBV/E (4%), HBV/A (1.6%) and HBV/C (0.5%). For HBV/D1, genomic mutations associated with HCC were T1673/G1679, G1727, C1741, C1761, A1757/T1764/G1766, T1773, T1773/G1775 and C1909. Age- and gender-adjusted stepwise logistic regression analysis indicated that mutations G1727 [odds ratio (OR) = 18.3; 95% confidence interval (CI) = 2.8-118.4; p = 0.002], A1757/T1764/G1766 (OR = 4.7; 95% CI = 1.3-17.2; p = 0.01) and T1773 (OR = 14.06; 95% CI = 2.3-84.8; p = 0.004) are independent predictors of HCC development. These results implicate novel individual and combination patterns of mutations in the X/precore region of HBV/D1 as predictors of HCC. Risk stratification based on these mutation complexes would be useful in determining high-risk patients and improving diagnostic and treatment strategies for HBV/D1.

Rationale and design of the Investigation of the Management of Pericarditis (IMPI) trial: a 2 × 2 factorial randomized double-blind multicenter trial of adjunctive prednisolone and Mycobacterium w immunotherapy in tuberculous pericarditis.

BACKGROUND: In spite of antituberculosis chemotherapy, tuberculous (TB) pericarditis causes death or disability in nearly half of those affected. Attenuation of the inflammatory response in TB pericarditis may improve outcome by reducing cardiac tamponade and pericardial constriction, but there is uncertainty as to whether adjunctive immunomodulation with corticosteroids and Mycobacterium w (M. w) can safely reduce mortality and morbidity. OBJECTIVES: The primary objective of the IMPI Trial is to assess the effectiveness and safety of prednisolone and M. w immunotherapy in reducing the composite outcome of death, constriction, or cardiac tamponade requiring pericardial drainage in 1,400 patients with TB pericardial effusion. DESIGN: The IMPI trial is a multicenter international randomized double-blind placebo-controlled 2 × 2 factorial study. Eligible patients are randomly assigned to receive oral prednisolone or placebo for 6 weeks and M. w injection or placebo for 3 months. Patients are followed up at weeks 2, 4, and 6 and months 3 and 6 during the intervention period and 6-monthly thereafter for up to 4 years. The primary outcome is the first occurrence of death, pericardial constriction, or cardiac tamponade requiring pericardiocentesis. The secondary outcome is safety of immunomodulatory treatment measured by effect on opportunistic infections (eg, herpes zoster) and malignancy (eg, Kaposi sarcoma) and impact on measures of immunosuppression and the incidence of immune reconstitution disease. CONCLUSIONS: IMPI is the largest trial yet conducted comparing adjunctive immunotherapy in pericarditis. Its results will define the role of adjunctive corticosteroids and M. w immunotherapy in patients with TB pericardial effusion.

Levothyroxine Timing during Ramadan: A Randomized Clinical Trial.

Introduction: Hypothyroidism requires lifelong thyroid hormone replacement with levothyroxine. For most hypothyroid patients fasting during Ramadan, compliance with the administration procedure is a challenge. This study aimed to determine the impact of different administration times of levothyroxine on thyroid-stimulating hormone (TSH) and free T4 (FT4) levels before and after the holy month of Ramadan. Materials and Methodology. Hypothyroid patients taking levothyroxine were randomized to 3 groups during Ramadan: group 1, 30 minutes before the iftar meal; group 2, 3-4 hours after the iftar meal, with no food taken for at least 1 hour after the meal; group 3, they were not given specific instructions for taking levothyroxine during Ramadan. Thyroid function tests were performed within 2 weeks before Ramadan and within 2 weeks after Ramadan. Pre- and post-Ramadan TSH and free T4 levels were compared. Mixed-effects analyzes were performed to identify factors associated with changes in TSH and FT4 levels. Results: Compliance was lower in patients taking levothyroxine 3-4 hours after iftar. In addition, the majority of patients who had not received a specific recommendation took levothyroxine 30 minutes before iftar. There was a statistically significant increase in TSH (P=0.006) and FT4 (P=0.044) levels after Ramadan. In multivariate analysis, the cause of hypothyroidism (Hashimoto's; postthyroidectomy; compared to postradioactive iodine) and levothyroxine dose significantly affected FT4 levels. In contrast, no variable was significantly associated with TSH level. The timing of levothyroxine intake during Ramadan did not significantly affect TSH or FT4 levels. Conclusion: TSH and FT4 significantly increased after Ramadan. However, the timing of levothyroxine intake per se had no influence on TSH or free T4 levels. Therefore, hypothyroid patients might take levothyroxine either 30 minutes or 3-4 hours after iftar with no meal for 1 hour, depending on preference.

Disseminated tuberculosis: Clinical presentation, diagnosis, and outcomes in a tertiary-care hospital in Saudi Arabia.

Background: Tuberculosis (TB) is the primary infectious cause of mortality worldwide. Although TB incidence and prevalence are declining, the use of immunosuppressive drugs and the growing prevalence of immunocompromising conditions such as comorbidities, malignancies, and the use of immunosuppressive agents are risk factors for disseminated TB (DTB). This study aims to identify the relevant clinical, laboratory, radiological, and histopathological features of DTB, as well as to assess the typical anatomical distributions and treatment outcomes of patients diagnosed with the disease at King Abdulaziz Medical City (KAMC). Methods: A retrospective chart review was conducted, including all patients diagnosed with miliary or DTB at KAMC with retrievable medical files. Results: The study included 55 patients, of whom 35 (63.6%) were male and the median age was 64 years old. 35 (63.6%) of the infected patients were timely diagnosed and eventually cured from the illness. The most common comorbid conditions were diabetes, chronic kidney disease, and immunocompromising conditions, which were present in 37 (67.2%), 12 (21.8%), and 11 (20%) of the patients, respectively. The most common presenting symptoms were fever and cough, present in 31 (56.3%) and 26 (47.2%) of the patients, respectively, followed by weight loss in 25 (45.4%), night sweats in 15 (27.2%), and shortness of breath in 14 (25.4%). Approximately two-thirds of the patients had pulmonary miliary TB (MTB) (38; 69.1%), followed by TB lymphadenitis (21; 38.2%), central nervous system involvement (13; 23.6%), skeletal involvement (11; 20%), gastrointestinal involvement (5; 9.1%), pleural involvement (3; 5.5%), and urogenital TB (2; 3.6%). The mortality rate was 14 (25.5%) patients. Conclusion: MTB is challenging to diagnose due to nonspecific clinical, laboratory, and imaging findings. Clinicians dealing with patients who are at risk of developing DTB should be aware of the typical presentations and abnormal clinical findings. They should also have a low threshold to initiate specific investigations for the disease, as early diagnosis and effective treatment is critical in reducing morbidity and mortality rates.

Factors associated with mortality and morbidity among pediatrics with burn injuries in Riyadh, Saudi Arabia.

OBJECTIVES: To describe characteristics, mechanism, and factors associated with morbidity and mortality of pediatrics with burn injuries. METHODS: This cross-sectional retrospective study examined all pediatrics with burn injuries carried out at King Abdulaziz Medical City, Riyadh, Saudi Arabia, from 2015-2020. Collected data included demographics, mechanism of burn, total body surface area (TBSA) burned, body region burned, incidence of infection, renal failure, scars, and respiratory events. RESULTS: The study included 370 patients. Approximately 47.0% were aged ≤2 years, and 61.0% were males. The most common burn mechanism was scald burn (54%), 59.2% had a TBSA of 0-10%, and 60.3% had regional burns on the upper limbs. During follow-up, 5 patients died (incidence rate [IR]=1.60/100 patient/years [PYs]). Morbidity events included blood/sepsis infection (IR=2.87/100 PYs), urine infection (IR=8.30/100 PYs), wound infection (IR=21.72/100 PYs), renal failure (IR=0.96/100 PYs), and respiratory infections (IR=1.60/100 PYs). In a multivariate Cox regression analysis, factors independently associated with combined hazard of morbidity and mortality were female gender (hazard ratio [HR]=1.64, 95% confidence intervel [CI]: [1.01-2.67], p=0.047), TBSA (HR=3.20, 95% CI: [1.828-5.585], p<0.0001), and length of hospital stay (HR=3.14, 95% CI: [1.91-5.17], p=0.000). CONCLUSION: This study identifies certain characteristics suggestive of poor outcomes of pediatric burn injuries that are relevant to clinical management and prevention programs. Larger multicenter studies are required to fully characterize pediatric patients with burn injuries and to identify factors that adversely affect their prognosis.

Prevalence and factors associated with dyslipidemia among adolescents in Saudi Arabia.

Dyslipidemia is a major risk factor for atherosclerosis. Screening for dyslipidemia at an early age is essential to prevent and control its consequences. This study aimed to determine prevalence of dyslipidemia and its correlates among adolescents in Saudi Arabia. Data of 5854 adolescents aged 10-19 years from all 13 regions of Saudi Arabia were obtained from the Jeeluna study; a national cross-sectional, multistage stratified cluster sample survey. Dyslipidemia was defined based on the National Heart Lung and Blood Institute and National Cholesterol Education Program guidelines for adolescents. We found that a quarter of Saudi adolescents have dyslipidemia (males: 33.3%, females: 17.9%). Significant variation was observed by region (p < 0.001). Prevalence of abnormal Total Cholesterol was 6.7%, LDL-C 7.1%, HDL-C 12.8%, Non-HDL-C 8.3%, and Triglycerides 9.6%. Factors independently associated with dyslipidemia were male gender (OR = 2.19, 95% CI 1.78-2.70, p < 0.001), BMI (underweight OR = 0.80, 95% CI 0.69-0.94, overweight OR = 1.76, 95% CI 1.50-2.06, obese OR = 2.80, 95% CI 2.34-3.34, p < 0.001, vs. normal) and serum ferritin (high OR = 7.02, 95% CI 1.49-34.79, low OR = 0.82, 95% CI 0.67-1.01, p = 0.04 vs. normal) and ≥ 1 daily intake of carbonated beverage (OR = 1.10, 95% CI 1.00-1.20, p = 0.03 vs. no or not daily intake). Public health interventions for improving lipid profile of adolescents are urgently needed.

Parents' perceptions of quality of life of their children and adolescents with type 1 diabetes during Ramadan fasting in Riyadh.

This study aimed to assess parents' perceptions of the quality of life (QoL) of their children with type 1 diabetes (T1D) during Ramadan fasting (RF). In this cross-sectional study, an Arabic-translated version of the standard diabetes-specific QoL questionnaire (PedsQL™ version 3.0) was used to compare perceptions of QoL during Ramadan month (Rm) versus non-Rm (NRm) of parents of children/adolescents with T1D from two tertiary hospitals in Riyadh. We used regression analysis to compare proxies (parents' reports) of their perceptions on their children/adolescents' QoL during Rm compared to NRm. A sample of 61 proxies (parents') of two age groups T1D offspring: 8-12 years (41%) and 13-18 years (59%) who reported their perceptions of their children/adolescents QoL during Rm were matched by children/adolescents' age and gender of 61 proxies in NRm. QoL scores of all domains were significantly lower in Rm compared to NRm; p < 0.0001, however, worries domain showed no statistical differences p = 0.052 in a regression analysis. The total aggregate median (IQR) in Rm was 850 (612-1,062) compared to 1,750 (1,475-2,062) in NRm, p < 0.001. The highest differences in NRm and Rm median scores were observed in communications (OR = 3.64; 95% CI 2.7-5.57) and treatment adherence (OR = 3.09; 95% CI 2.48-3.84) domains especially in the age of 13-18 years. Parents of adolescent boys, who are usually risk-takers and more exposed to outdoor activities, perceived lower QoL for them. Parents of adolescents with T1D perceived a lower QoL for their children during RF, especially in the treatment adherence and communication domains.