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Erythropoietin might have neurocytoprotective effects. In this trial, we studied its effect on neurological recovery, mortality, and venous thrombotic events in patients with traumatic brain injury. Erythropoietin in Traumatic Brain Injury (EPO-TBI) was a double-blind, placebo-controlled trial undertaken in 29 centres (all university-affiliated teaching hospitals) in seven countries (Australia, New Zealand, France, Germany, Finland, Ireland, and Saudi Arabia). Within 24 h of brain injury, 606 patients were randomly assigned by a concealed web-based computer-generated randomisation schedule to erythropoietin (40 000 units subcutaneously) or placebo (0·9% sodium chloride subcutaneously) once per week for a maximum of three doses. Randomisation was stratified by severity of traumatic brain injury (moderate vs severe) and participating site. With the exception of designated site pharmacists, the site dosing nurses at all sites, and the pharmacists at the central pharmacy in France, all study personnel, patients, and patients' relatives were masked to treatment assignment. The primary outcome, assessed at 6 months by modified intention-to-treat analysis, was improvement in the patients' neurological status, summarised as a reduction in the proportion of patients with an Extended Glasgow Outcome Scale (GOS-E) of 1–4 (death, vegetative state, and severe disability). Two equally spaced preplanned interim analyses were done (after 202 and 404 participants were enrolled). This study is registered with ClinicalTrials.gov, number NCT00987454. Between May 3, 2010, and Nov 1, 2014, 606 patients were enrolled and randomly assigned to erythropoietin (n=308) or placebo (n=298). Ten of these patients (six in the erythropoietin group and four in the placebo group) were lost to follow up at 6 months; therefore, data for the primary outcome analysis was available for 596 patients (302 in the erythropoietin group and 294 in the placebo group). Compared with placebo, erythropoietin did not reduce the proportion of patients with a GOS-E level of 1–4 (134 [44%] of 302 patients in the erythropoietin group vs 132 [45%] of 294 in the placebo group; relative risk [RR] 0·99 [95% CI 0·83–1·18], p=0·90). In terms of safety, erythropoietin did not significantly affect 6-month mortality versus placebo (32 [11%] of 305 patients had died at 6 months in the erythropoietin group vs 46 [16%] of 297 [16%] in the placebo group; RR 0·68 [95% CI 0·44–1·03], p=0·07) or increase the occurrence of deep venous thrombosis of the lower limbs (48 [16%] of 305 vs 54 [18%] of 298; RR 0·87 [95% CI 0·61–1·24], p=0·44). Following moderate or severe traumatic brain injury, erythropoietin did not reduce the number of patients with severe neurological dysfunction (GOS-E level 1–4) or increase the incidence of deep venous thrombosis of the lower limbs. The effect of erythropoietin on mortality remains uncertain. The National Health and Medical Research Council and the Transport Accident Commission.

Background Cardiovascular disease (CVD) is the major cause of death in Saudi Arabia. We aimed to assess associated demographic, behavioral, and CVD risk factors as part of the Prospective Urban Rural Epidemiology (PURE) study. Methods PURE is a global cohort study of adults ages 35–70 years in 20 countries. PURE-Saudi study participants were recruited from 19 urban and 6 rural communities randomly selected from the Central province (Riyadh and Alkharj) between February 2012 and January 2015. Data were stratified by age, sex, and urban vs rural and summarized as means and standard deviations for continuous variables and as numbers and percentages for categorical variables. Proportions and means were compared between men and women, among age groups, and between urban and rural areas, using Chi-square test and t-tests, respectively. Results The PURE-Saudi study enrolled 2047 participants (mean age, 46.5 ± 9.12 years; 43.1% women; 24.5% rural). Overall, 69.4% had low physical activity, 49.6% obesity, 34.4% unhealthy diet, 32.1% dyslipidemia, 30.3% hypertension, and 25.1% diabetes. In addition, 12.2% were current smokers, 15.4% self-reported feeling sad, 16.9% had a history of periods of stress, 6.8% had permanent stress, 1% had a history of stroke, 0.6% had heart failure, and 2.5% had coronary heart disease (CHD). Compared to women, men were more likely to be current smokers and have diabetes and a history of CHD. Women were more likely to be obese, have central obesity, self-report sadness, experience stress, feel permanent stress, and have low education. Compared to participants in urban areas, those in rural areas had higher rates of diabetes, obesity, and hypertension, and lower rates of unhealthy diet, self-reported sadness, stress (several periods), and permanent stress. Compared to middle-aged and older individuals, younger participants more commonly reported an unhealthy diet, permanent stress, and feeling sad. Conclusion These results of the PURE-Saudi study revealed a high prevalence of unhealthy lifestyle and CVD risk factors in the adult Saudi population, with higher rates in rural vs urban areas. National public awareness programs and multi-faceted healthcare policy changes are urgently needed to reduce the future burden of CVD risk and mortality.

Background/Aim: To provide the most recent estimate of childhood obesity and determine the trend in childhood obesity in Riyadh city over the past two decades, by comparing our results with previous studies that published data comparable to our study in terms of geography, sample age (6-16 years), and use of World Health Organization (WHO) cut-offs to define obesity. Patients and Methods: A cross-sectional study was conducted in 2015 among school children in Riyadh city. A sample of 7930 children (67% girls) aged 6-16 years were randomly selected. Body mass index for age and gender above +1 and below +2 standard deviation scores (SDS) defined overweight (SDS, z-scores) and >+2 SD scores defined obesity. Results: The overall prevalence of overweight and obesity was 13.4% (14.2% for girls and 12% for boys; P= 0.02) and 18.2% (18% for girls and 18.4% for boys; P = 0.73), respectively. When compared with the WHO-based national prevalence rate of obesity reported in 2004 (≈9.3%), the obesity rate has doubled over a 10-year period. There was a significantly higher prevalence of obesity in adolescents (>11 years) than in children (20.2% vs 15.7%; P < 0.01). Overweight and obesity increased significantly with higher levels of socioeconomic status. Obese children were at 1.5 and 2 times risk of developing gas bloating and vomiting than non-obese children. Conclusion: The prevalence of overweight and obesity has risen alarmingly among Saudi children and adolescents over the past decade and should make a strong case to initiate and monitor effective implementation of obesity prevention measures.

In this large-scale cluster-randomized controlled trial (cRCT) we sought to assess the effectiveness of facemasks against viral respiratory infections. Over three consecutive Hajj seasons (2013, 2014, 2015) pilgrims' tents in Makkah were allocated to 'facemask' or 'no facemask' group. Fifty facemasks were offered to participants in intervention tents, to be worn over four days, and none were offered to participants in control tents. All participants recorded facemask use and respiratory symptoms in health diaries. Nasal swabs were collected from the symptomatic for virus detection by reverse transcription polymerase chain reaction. Clinical symptoms and laboratory results were analyzed by 'intention- to-treat' and 'per-protocol'. A total of 7687 adult participants from 318 tents were randomized: 3864 from 149 tents to the intervention group, and 3823 from 169 tents to the control group. Participants were aged 18 to 95 (median 34, mean 37) years, with a male to female ratio of 1:1.2. Overall, respiratory viruses were detected in 277 of 650 (43%) nasal/pharyngeal swabs collected from symptomatic pilgrims. Common viruses were rhinovirus (35.1%), influenza (4.5%) and parainfluenza (1.7%). In the intervention arm, respectively 954 (24.7%) and 1842 (47.7%) participants used facemasks daily and intermittently, while in the control arm, respectively 546 (14.3%) and 1334 (34.9%) used facemasks daily and intermittently. By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (odds ratio [OR], 1.4; 95% confidence interval [CI], 0.9 to 2.1, p = 0.18) nor against clinical respiratory infection (OR, 1.1; 95% CI, 0.9 to 1.4, p = 0.40). Similarly, in a per-protocol analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections (OR 1.2, 95% CI 0.9-1.7, p = 0.26) nor against clinical respiratory infection (OR 1.3, 95% CI 1.0-1.8, p = 0.06). This trial was unable to provide conclusive evidence on facemask efficacy against viral respiratory infections most likely due to poor adherence to protocol.

Overweight and obesity are becoming increasingly prevalent among children and adolescents in Saudi Arabia and are an emerging cause of non-communicable diseases (NCDs). Lifestyle factors, such as insufficient levels of physical activity and sedentary behaviors, are responsible for the increased prevalence of NCDs. This study aimed to determine the association between physical activity levels, sedentary behaviors, and anthropometric measurements in Saudi female adolescents. A cross-sectional study was carried out among 399 healthy female adolescent students aged 13–14 years in Arar, Saudi Arabia. The participants were randomly selected from different schools and their anthropometric measurements were determined. The Physical Activity Questionnaire for Older Children (PAQ-C) and the Adolescent Sedentary Activity Questionnaire (ASAQ) were used to assess their physical activity levels and sedentary behaviors, and an analysis was conducted using IBM SPSS software version 25. A multiple linear regression model was used to determine the association between the variables. The majority of the participants had a normal body mass index (BMI; 79.4%) and waist circumference (WC; 62.4%). A total of 74.4% had waist to height ratio (WHtR) < 0.5. About 92.7% of the participants were not meeting PA recommendations of 60 min of moderate to vigorous physical activity daily. The overall mean time spent on sedentary activities was high on both weekdays and weekend days at 357.64 ± 86.29 and 470.51 ± 147.64 min/day, respectively. Moreover, anthropometric measurement (BMI) was positively associated with age and negatively associated with sedentary behavior on weekends, while WHtR was positively associated with age. The multiple linear regression analysis also showed that age and sedentary behavior significantly predicted BMI among the study participants (F (2, 396) = 4.346, p < 0.014) and age was the only significant predictor of WHtR (F (1, 397) = 16.191, p ≤ 0.001). This study revealed that most of the female Saudi adolescents undertook low levels of activity and high levels of sedentary behaviors. Sedentary behaviors were significantly associated with their BMI. Accordingly, an intervention program on healthy lifestyles is important to improve Saudi female adolescents’ lifestyles.

Aim: This 18 month intervention study aims to determine the efficacy of a lifestyle modification program on prediabetes reversal among Saudi adults. Methods: An 18 month randomized, multicenter trial was conducted among Saudis with prediabetes aged 25–60 recruited from King Salman Hospital and primary care centers in Riyadh, Saudi Arabia. A total of 180 consenting individuals were randomized (1:1) to receive either intensive lifestyle intervention (ILIG) or guidance (control group, CG). ILIG was provided with a personalized lifestyle counseling by nutritionists every 3 months to improve diet and exercise behaviors. CG was given booklets containing information on prediabetes and its prevention. Data from lifestyle assessments and laboratory measurements were analyzed at baseline and every 6 months. The primary outcome was the reversal rate of prediabetes. Results: 158 participants were analyzed (CG:85, ILIG:73) at the 12 month follow-up and 28 participants (CG:11 and ILIG:17) completed the entire 18 month study. Post-intervention, the cumulative incidence of prediabetes reversal in the ILIG was 38 participants (52.1%) which was significantly higher than CG with 26 participants (30.6%) (p = 0.02). Conclusion: A tailored lifestyle intervention is effective in reversing prediabetes, at least for a year, among Arab adults with prediabetes. The challenge of sustaining interest in adopting lifestyle changes for a longer duration should be addressed in this population.

This study aimed to identify certain occupational risk factors for stress among healthcare workers (HCWs) during the COVID-19 pandemic. Using a multistage random sampling approach, an online questionnaire was applied to collect data on role conflict and ambiguity, self-esteem and social support from 1378 HCWs working in primary health centers (regular and fever clinics; clinics specialized in managing patients with COVID-19 symptoms) across Saudi Arabia. The results showed that stress correlated positively with role conflict and ambiguity and negatively with social support. HCWs in fever clinics exhibited significantly more stress and role conflict and ambiguity than those who were working in regular primary healthcare centers. In conclusion, role conflict and ambiguity and social support were determinants for stress among HCWs, especially those working in fever clinics.

Recent studies have reported a high prevalence of relative adrenal insufficiency in patients with liver cirrhosis. However, the effect of corticosteroid replacement on mortality in this high-risk group remains unclear. We examined the effect of low-dose hydrocortisone in patients with cirrhosis who presented with septic shock. We enrolled patients with cirrhosis and septic shock aged 18 years or older in a randomized double-blind placebo-controlled trial. Relative adrenal insufficiency was defined as a serum cortisol increase of less than 250 nmol/L or 9 μg/dL from baseline after stimulation with 250 μg of intravenous corticotropin. Patients were assigned to receive 50 mg of intravenous hydrocortisone or placebo every six hours until hemodynamic stability was achieved, followed by steroid tapering over eight days. The primary outcome was 28-day all-cause mortality. The trial was stopped for futility at interim analysis after 75 patients were enrolled. Relative adrenal insufficiency was diagnosed in 76% of patients. Compared with the placebo group (n = 36), patients in the hydrocortisone group (n = 39) had a significant reduction in vasopressor doses and higher rates of shock reversal (relative risk [RR] 1.58, 95% confidence interval [CI] 0.98–2.55, p = 0.05). Hydrocortisone use was not associated with a reduction in 28-day mortality (RR 1.17, 95% CI 0.92–1.49, p = 0.19) but was associated with an increase in shock relapse (RR 2.58, 95% CI 1.04–6.45, p = 0.03) and gastrointestinal bleeding (RR 3.00, 95% CI 1.08–8.36, p = 0.02). Relative adrenal insufficiency was very common in patients with cirrhosis presenting with septic shock. Despite initial favourable effects on hemodynamic parameters, hydrocortisone therapy did not reduce mortality and was associated with an increase in adverse effects. (Current Controlled Trials registry no. ISRCTN99675218.)

Background: The COVID-19 pandemic has disastrous impacts that impose the cultivation of knowledge and motivation of self-protection to foster disease containment. Aim: Evaluate the effect of digital self-learned educational intervention about COVID-19 using the protection motivation theory (PMT) on non-health students’ knowledge and self-protective behaviors at Saudi Electronic University (SEU). Methods: A quasi-experimental study was accomplished at three randomly chosen branches of SEU (Riyadh, Dammam, Jeddah) using a multistage sampling technique to conveniently select 219 students. An electronic self-administered questionnaire was used, which included three scales for assessing the students’ knowledge, self-protective behaviors, and the constructs of the PMT. The educational intervention was designed using four stages: need assessment, planning, implementation, and evaluation. A peer-reviewed digital educational content was developed after assessing the participants’ educational needs using the pretest. Then, distributed through their university emails. A weekly synchronous Zoom cloud meeting and daily key health messages were shared with them. Finally, the post-test was conducted after two months. Results: The mean participants’ age (SD) among the experimental group was 28.94 (6.719), and the control group was 27.80 (7.256), with a high female percentage (63.4%, 73.8%) and a previous history of direct contact with verified COVID-19 patients (78.6%, 69.2%), respectively. A significant positive mean change (p = 0.000) was detected in the total COVID-19 knowledge of the experimental group post-intervention, either when it was adjusted for the covariates effect of the control group (F1 = 630.547) or the pretest (F1 = 8.585) with a large effect size (η2 = 0.745, η2 = 0.268, respectively). The same was proved by the ANCOVA test for the total self-protective behaviors either when it adjusted for the covariates effect of the control group (F1 = 66.671, p = 0.000) or the pretest (F1 = 5.873, p = 0.020) with a large effect size (η2 = 0.236, η2 = 0.164, respectively). The ANCOVA test proved that post-intervention, all the PMT constructs (perceived threats, reward appraisal, efficacy appraisal, response cost, and protection intention) and the total PMT score were significantly improved (p = 0.000) among the experimental group either when adjusted for the covariates effect of the control group (F1 = 83.835) or the pretest (F1 = 11.658) with a large effect size (η2 = 0.280, η2 = 0.561, respectively). Conclusions: The digital PMT-based self-learned educational intervention effectively boosts non-health university students’ COVID-19 knowledge, protection motivation, and self-protective behaviors. Thus, PMT is highly praised as a basis for COVID-19-related educational intervention and, on similar occasions, future outbreaks.

Objectives The purpose of this study was to investigate the effect of remotely delivered telemedicine dietary advice on monitoring of blood glucose levels and weight gain of women with gestational diabetes mellitus (GDM). Methods Women with GDM were recruited and randomly allocated into two groups: a Tele-GDM group that received a telemonitoring device, and a control group that was followed-up traditionally. A telemonitoring service calculated the ratio of reaching or exceeding the pregnancy weight gain target (according to pre-pregnancy weight), following Institute of Medicine guidelines for healthy pregnancy weight gain. Results The sample comprised 27 women in the Tele-GDM group and 30 in the control group. At the end of pregnancy, the Tele-GDM group showed significantly lower 2-hour postprandial glucose levels than the control group. Most women in the Tele-GDM group reached their recommended range of weight gain at the end of pregnancy. Additionally, the Tele-GDM group showed significantly lower weight gain than the control group. Conclusions Telemonitoring can facilitate close monitoring of women with GDM and motivate patients to adopt a healthy lifestyle.