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author:("tamil, Hani")
1.  Tertiary care availability and adolescent pregnancy characteristics in Saudi Arabia 
Background
In this study, we aimed to assess the rate of adolescent delivery in a Saudi tertiary health care center and to investigate the association between maternal age and fetal, neonatal, and maternal complications where a professional tertiary medical care service is provided.
Methods
A cross-sectional study was performed between 2005 and 2010 at King Abdulaziz Medical City, Riyadh, Saudi Arabia. All primigravid Saudi women ≥24 weeks gestation, carrying a singleton pregnancy, aged <35 years, and with no chronic medical problems were eligible. Women were divided into three groups based on their age, ie, group 1 (G1) <16 years, group 2 (G2) ≥16 up to 19 years, and group 3 (G3) ≥19 up to 35 years. Data were collected from maternal and neonatal medical records. We calculated the association between the different age groups and maternal characteristics, as well as events and complications during the antenatal period, labor, and delivery.
Results
The rates of adolescent delivery were 20.0 and 16.3 per 1,000 births in 2009 and 2010, respectively. Compared with G1 and G2 women, G3 women tended to have a higher body mass index, a longer first and second stage of labor, more blood loss at delivery, and a longer hospital stay. Compared with G1 and G2 women, respectively, G3 women had a 42% and a 67% increased risk of cesarean section, and had a 52% increased risk of instrumental delivery. G3 women were more likely to develop gestational diabetes or anemia, G2 women had a three-fold increased risk of premature delivery (odds ratio 2.81), and G3 neonates had a 50% increased overall risk of neonatal complications (odds ratio 0.51).
Conclusion
The adolescent birth rate appears to be low in central Saudi Arabia compared with other parts of the world. Excluding preterm delivery, adolescent delivery cared for in a tertiary health care center is not associated with a significantly increased medical risk to the mother, fetus, or neonate. The psychosocial effect of adolescent pregnancy and delivery needs to be assessed.
doi:10.2147/IJWH.S57743
PMCID: PMC3979779
adolescent pregnancy; maternal mortality; maternal morbidity; neonatal mortality; neonatal morbidity
2.  Vitamin D status among patients visiting a tertiary care center in Riyadh, Saudi Arabia: a retrospective review of 3475 cases 
BMC Public Health  2014;14:159.
Background
Vitamin D deficiency has been implicated in several chronic, non-communicable diseases independent of its conventional role in bone and calcium homeostasis. In this retrospective study, we determined the prevalence of vitamin D deficiency and its association to several cardiometabolic indices among patients visiting King Abdulaziz Medical City (KAMC), a tertiary hospital in Riyadh, Saudi Arabia.
Methods
A total of 3475 charts of out-patient subjects who visited KAMC from September 2009 until December 2010 were reviewed and included. Variables of interest included measurements of vitamin D status, glycemic and renal profile, as well as trace elements (calcium and phosphorous).
Results
The over-all prevalence of vitamin D deficiency in the cohort studied was 78.1% in females and 72.4% in males. 25(OH) vitamin D was significantly associated with increasing age and weight (p-values < 0.0001 and 0.005, respectively). It was also positively associated with albumin, calcium and phosphorous (p-values < 0.0001, < 0.0001 and 0.0007, respectively) and negatively associated with alkaline phosphatase as well as circulating levels of PTH (p-values 0.0002 and 0.0007, respectively).
Conclusion
In conclusion, vitamin D deficiency is overwhelmingly common among patients seen at KAMC regardless of the medical condition, and it is significantly associated with increasing age, weight and markers of calcium homeostasis. Findings of the present study further stress the spotlight on vitamin D deficiency epidemic in the country and region in general.
doi:10.1186/1471-2458-14-159
PMCID: PMC3942273  PMID: 24524260
Vitamin D; Vitamin D deficiency; Saudi
3.  A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial 
BMC Public Health  2014;14:36.
Background
Breastfeeding has countless benefits to mothers, children and community at large, especially in developing countries. Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates. Evidence reveals that antenatal breastfeeding education, professional lactation support, and peer lay support are individually effective at increasing breastfeeding duration and exclusivity, particularly in low-income settings. Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon, we hypothesize that a complex breastfeeding support intervention, which is centered on the three components mentioned above, would significantly increase breastfeeding rates.
Methods/Design
A multi-center randomized controlled trial. Study population: 443 healthy pregnant women in their first trimester will be randomized to control or intervention group. Intervention: A “prenatal/postnatal” professional and peer breastfeeding support package continuing till 6 months postpartum, guided by the Social Network and Social Support Theory. Control group will receive standard prenatal and postnatal care. Mothers will be followed up from early pregnancy till five years after delivery. Outcome measures: Total and exclusive breastfeeding rates, quality of life at 1, 3 and 6 months postpartum, maternal breastfeeding knowledge and attitudes at 6 months postpartum, maternal exclusive breastfeeding rates of future infants up to five years from baseline, cost-benefit and cost-effectiveness analyses of the intervention. Statistical analysis: Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS.
Discussion
Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality. In a country with limited healthcare resources like Lebanon, developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority. If positive, the results of this study would provide a generalizable model to bolster breastfeeding promotion efforts and contribute to improved child health in Lebanon and the Middle East and North Africa (MENA) region.
Trial registration
Current Controlled Trials ISRCTN17875591
doi:10.1186/1471-2458-14-36
PMCID: PMC3898488  PMID: 24428951
Breastfeeding; Lay support; Cost analysis; Lactation support; Knowledge; Attitudes; Social network; Social support theory
4.  Risk factors, management and outcomes of patients admitted with near fatal asthma to a tertiary care hospital in Riyadh 
Annals of Thoracic Medicine  2014;9(1):33-38.
RATIONALE:
Near-fatal asthma (NFA) has not been well studied in Saudi Arabia. We evaluated NFA risk factors in asthmatics admitted to a tertiary-care hospital and described NFA management and outcomes.
MATERIALS AND METHODS:
This was a retrospective study of NFA patients admitted to an ICU in Riyadh (2006-2010). NFA was defined as a severe asthma attack requiring intubation. To evaluate NFA risk factors, randomly selected patients admitted to the ward for asthma exacerbation were used as controls. Collected data included demographics, information on prior asthma control and various NFA treatments and outcomes.
RESULTS:
Thirty NFA cases were admitted to the ICU in the five-year period. Compared to controls (N = 120), NFA patients were younger (37.5 ± 19.9 vs. 50.3 ± 23.1 years, P = 0.004) and predominantly males (70.0% vs. 41.7%, P = 0.005) and used less inhaled steroids/long-acting ß2-agonists combination (13.6% vs. 38.7% P = 0.024. Most (73.3%) NFA cases presented in the cool months (October-March). On multivariate analysis, age (odds ratio [OR] 0.96; 95% confidence interval [CI], 0.92-0.99, P = 0.015) and the number of ED visits in the preceding year (OR, 1.25; 95% CI, 1.00-1.55) were associated with NFA. Rescue NFA management included ketamine (50%) and theophylline (19%) infusions. NFA outcomes included: neuromyopathy (23%), mechanical ventilation duration = 6.4 ± 4.7 days, tracheostomy (13%) and mortality (0%). Neuromuscular blockade duration was associated with neuromyopathy (OR, 3.16 per one day increment; 95% CI, 1.27-7.83).
CONCLUSIONS:
In our study, NFA risk factors were younger age and higher number of ED visits. NFA had significant morbidity. Reducing neuromuscular blockade duration during ventilator management may decrease neuromyopathy risk.
doi:10.4103/1817-1737.124441
PMCID: PMC3912685  PMID: 24551016
Asthma; critical illness; mechanical ventilation; neuromyopathy
5.  Venous Thromboembolism in Critically Ill Cirrhotic Patients: Practices of Prophylaxis and Incidence 
Thrombosis  2013;2013:807526.
Objectives. We compared venous thromboembolism (VTE) prophylaxis practices and incidence in critically ill cirrhotic versus noncirrhotic patients and evaluated cirrhosis as a VTE risk factor. Methods. A cohort of 798 critically ill patients followed for the development of clinically detected VTE were categorized according to the diagnosis of cirrhosis. VTE prophylaxis practices and incidence were compared. Results. Seventy-five (9.4%) patients had cirrhosis with significantly higher INR (2.2 ± 0.9 versus 1.3 ± 0.6, P < 0.0001), lower platelet counts (115,000 ± 90,000 versus 258,000 ± 155,000/μL, P < 0.0001), and higher creatinine compared to noncirrhotic patients. Among cirrhotics, 31 patients received only mechanical prophylaxis, 24 received pharmacologic prophylaxis, and 20 did not have any prophylaxis. Cirrhotic patients were less likely to receive pharmacologic prophylaxis (odds ratio, 0.08; 95% confidence interval (CI), 0.04–0.14). VTE occurred in only two (2.7%) cirrhotic patients compared to 7.6% in noncirrhotic patients (P = 0.11). The incidence rate was 2.2 events per 1000 patient-ICU days for cirrhotic patients and 3.6 events per 1000 patient-ICU days for noncirrhotics (incidence rate ratio, 0.61; 95% CI, 0.15–2.52). On multivariate Cox regression analysis, cirrhosis was not associated with VTE risk (hazard ratio, 0.40; 95% CI, 0.10–1.67). Conclusions. In critically ill cirrhotic patients, VTE incidence did not statistically differ from that in noncirrhotic patients.
doi:10.1155/2013/807526
PMCID: PMC3872442  PMID: 24386564
6.  Maternal and neonatal risk factors for early-onset group B streptococcal disease: a case control study 
Objectives
To identify the prominent maternal and neonatal risk factors associated with early-onset group B streptococcus (EOGBS) disease in neonates and to determine their importance by comparing them with a control group.
Setting
Neonatal unit at King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia.
Patients
Cases were infants <7 days of age with invasive group B streptococcus (GBS) disease diagnosed between January 1, 2000 and December 31, 2009. Controls were healthy infants born in the same hospital during the same period having the same birth weight and gestational age category.
Main outcome measures
Maternal risk factors for developing EOGBS disease, feto–maternal and neonatal clinical data, their morbidities, mortalities, and length of hospital stay.
Results
A total of 99 cases and 200 controls were included. The majority of cases presented in the first 72 hours of life (62/99 [63.9%]), of which 87/99 (89.7%) had at least one clinical risk factor for the development of EOGBS disease. Mothers of neonates with EOGBS disease were more likely to have GBS bacteriuria (odds ratio [OR] 10.76, 95% confidence interval [CI] 1.24–93.42), infection in the peripartum period (OR 8.92, CI 2.87–27.68), and temperature ≥38°C (OR 7.10, CI 2.50–20.17). GBS disease was associated with premature rupture of membranes and fetal tachycardia (P<0.01 for both). Neonates with EOGBS disease were more likely to have respiratory distress disease and convulsions, require tube feeding, and have longer hospital stays compared with the controls (P<0.01 for all). Stepwise multiple logistic regression has identified three risk factors that were associated with the highest tendency for the development of EOGBS disease. These were lack of antenatal attendance (OR =0.30 and CI 0.98–0.88), rupture of membranes (OR =9.62 and CI 3.1–29.4), and antibiotic use in labor (OR =0.16 and CI 0.38–0.67).
Conclusion
A number of maternal risk factors were significantly associated with EOGBS disease. Taking these factors into consideration may result in preventing the occurrence of EOGBS disease, improve maternal and neonatal medical care, decrease their hospital stay, and reduce unnecessary hospital resource utilization.
doi:10.2147/IJWH.S52206
PMCID: PMC3814928  PMID: 24194650
group B streptococcus; neonatal morbidity; maternal morbidity; antenatal screening
7.  Discrepancies between two lipid-lowering guidelines for CVD prevention in seemingly healthy individuals—case study Lebanon 
Background
In deciding on optimal interventions for cardiovascular disease (CVD) prevention, more than one set of guidelines are available.
Hypothesis
The aim of the study was to assess the agreement between the European Society of Cardiology (ESC) 2011 Guidelines for CVD Prevention and the Canadian Cardiovascular Society (CCS) 2009 Guidelines in recommending lipid lowering interventions in a seemingly healthy cohort of Lebanese persons.
Methods
A nationally representative cohort of Lebanon was identified according to the World Health Organization (WHO) Steps Criteria. From this cohort, a group of 283 adult individuals not known to have chronic illnesses was selected. Using the algorithms present in each guideline, lipid lowering recommendations for each individual were determined. Agreement between the two guideline recommendations was determined using the Kappa test.
Results
As per ESC, 3.9% of the participants required immediate drug therapy, 15.5% should be considered for drug therapy, and 80.1% required lifestyle intervention. As per the CCS, however, 19.4% required drug therapy. The overall level of agreement between the ESC and CCS for recommending lipid lowering was moderate (Kappa 0.77), and better in males (Kappa 0.82). In contrast, 37.5% of females recommended drug therapy as per the CCS guidelines would not be per the ESC guidelines (Kappa 0.63).
Conclusions
Significant discrepancies exist in recommendations for lipid-lowering therapy between CCS and ESC guidelines when applied to Lebanese individuals, particularly for women. Local healthcare authorities and the WHO should attend to this issue in order to unify treatment approaches and limit disparities in care.
doi:10.3978/j.issn.2223-3652.2013.07.01
PMCID: PMC3839203  PMID: 24282761
Applicability; guidelines; cardiovascular disease; prevention; statins
8.  Prevalence and associated factors of polypharmacy among adult Saudi medical outpatients at a tertiary care center 
Objective:
The objective of this study was to assess the prevalence of polypharmacy (PP) and the associated factors in medical outpatients.
Materials and Methods:
A cross-sectional, observational, descriptive study was carried out in adult medical outpatients attending internal medicine clinics at King Abdulaziz Medical City, Riyadh, Saudi Arabia from 1 March 2009 to 31 December 2009. PP was defined as the concomitant use of ≥5 medications daily. The number of medications being currently taken by patient was recorded. Effect of patients’ age, gender, educational level, number of prescribers, disease load and disease type on PP was assessed by multivariate analysis using Statistical Package for Social Sciences Incorporated (SPSS Inc) Version 18.
Results:
Out of 766 patients included in the study, 683 (89%) had PP. The mean number of prescribed medications, oral pills and doses was 8.8, 9.6 and 12.1, respectively. Factors significantly associated with PP included age (≥61 years), disease load and the number of prescribers. Gender had no impact on PP while education beyond primary education significantly decreased PP. Hypertension, diabetes mellitus and dyslipidemia alone and as a cluster increased PP.
Conclusion:
We found an extremely high level of PP in medical outpatients at our tertiary care center. The impact of PP on medication compliance and control of underlying diseases in Saudi Arabia is unknown and needs to be studied at different levels of care.
doi:10.4103/2230-8229.121987
PMCID: PMC3957169  PMID: 24672273
Medical; medications; outpatients; polypharmacy
9.  Demographics and outcomes of critically ill patients transferred from other hospitals to a tertiary care academic referral center in Saudi Arabia 
Background
The objective of this study was to examine the outcomes of critically ill patients who were transferred from other hospitals to a tertiary care center in Saudi Arabia as a quality improvement project.
Methods
This was a retrospective study of adult patients admitted to the medical-surgical intensive care unit (ICU) of a tertiary care hospital. Patients were divided according to the source of referral into three groups: transfers from other hospitals, and direct admissions from emergency department (ED) and from hospital wards. Standardized mortality ratio (SMR) was calculated. Multivariate analysis was performed to determine the independent predictors of mortality.
Results
Of the 7,654 patients admitted to the ICU, 611 patients (8%) were transferred from other hospitals, 2,703 (35.3%) were direct admissions from ED and 4,340 (56.7%) from hospital wards. Hospital mortality for patients transferred from other hospitals was not significantly different from those who were directly admitted from ED (35% vs. 33.1%, p = 0.37) but was lower than those who were directly admitted from hospital wards (35% vs. 51.2%, p < 0.0001). SMRs did not differ significantly across the three groups.
Conclusions
Critically ill patients who were transferred from other hospitals constituted 8% of all ICU admissions. Mortality of these patients was similar to patients with direct admission from the ED and lower than that of patients with direct admission from hospital wards. However, risk-adjusted mortality was not different from the other two groups.
doi:10.1186/2110-5820-3-26
PMCID: PMC3751539  PMID: 23937989
Emergency department; Hospital mortality; Hospital wards; Intensive care unit; Mortality; Ambulance; Trauma
10.  Clinical characteristics, sepsis interventions and outcomes in the obese patients with septic shock: an international multicenter cohort study 
Critical Care  2013;17(2):R72.
Introduction
Data are sparse as to whether obesity influences the risk of death in critically ill patients with septic shock. We sought to examine the possible impact of obesity, as assessed by body mass index (BMI), on hospital mortality in septic shock patients.
Methods
We performed a nested cohort study within a retrospective database of patients with septic shock conducted in 28 medical centers in Canada, United States and Saudi Arabia between 1996 and 2008. Patients were classified according to the World Health Organization criteria for BMI. Multivariate logistic regression analysis was performed to evaluate the association between obesity and hospital mortality.
Results
Of the 8,670 patients with septic shock, 2,882 (33.2%) had height and weight data recorded at ICU admission and constituted the study group. Obese patients were more likely to have skin and soft tissue infections and less likely to have pneumonia with predominantly Gram-positive microorganisms. Crystalloid and colloid resuscitation fluids in the first six hours were given at significantly lower volumes per kg in the obese and very obese patients compared to underweight and normal weight patients (for crystalloids: 55.0 ± 40.1 ml/kg for underweight, 43.2 ± 33.4 for normal BMI, 37.1 ± 30.8 for obese and 27.7 ± 22.0 for very obese). Antimicrobial doses per kg were also different among BMI groups. Crude analysis showed that obese and very obese patients had lower hospital mortality compared to normal weight patients (odds ratio (OR) 0.80, 95% confidence interval (CI) 0.66 to 0.97 for obese and OR 0.61, 95% CI 0.44 to 0.85 for very obese patients). After adjusting for baseline characteristics and sepsis interventions, the association became non-significant (OR 0.80, 95% CI 0.62 to 1.02 for obese and OR 0.69, 95% CI 0.45 to 1.04 for very obese).
Conclusions
The obesity paradox (lower mortality in the obese) documented in other populations is also observed in septic shock. This may be related in part to differences in patient characteristics. However, the true paradox may lie in the variations in the sepsis interventions, such as the administration of resuscitation fluids and antimicrobial therapy. Considering the obesity epidemic and its impact on critical care, further studies are warranted to examine whether a weight-based approach to common therapeutic interventions in septic shock influences outcome.
doi:10.1186/cc12680
PMCID: PMC3672731  PMID: 23594407
11.  Age- and Gender-Specific Reference Intervals for Fasting Blood Glucose and Lipid Levels in School Children Measured With Abbott Architect c8000 Chemistry Analyzer 
Reference intervals for pubertal characteristics are influenced by genetic, geographic, dietary and socioeconomic factors. Therefore, the aim of this study was to establish age-specific reference intervals of glucose and lipid levels among local school children. This was cross-sectional study, conducted among Saudi school children. Fasting blood samples were collected from 2149 children, 1138 (53%) boys and 1011 (47%) girls, aged 6 to 18 years old. Samples were analyzed on the Architect c8000 Chemistry System (Abbott Diagnostics, USA) for glucose, cholesterol, triglycerides, HDL and LDL. Reference intervals were established by nonparametric methods between the 2.5th and 97.5th percentiles. Significant differences were observed between boys and girls for cholesterol and triglycerides levels in all age groups (P < 0.02). Only at age 6–7 years and at adolescents, HDL and LDL levels were found to be significant (P < 0.001). No significant differences were seen in glucose levels except at age 12 to 13 years. Saudi children have comparable serum cholesterol levels than their Western counterparts. This may reflect changing dietary habits and increasing affluence in Saudi Arabia. Increased lipid screening is anticipated, and these reference intervals will aid in the early assessment of cardiovascular and diabetes risk in Saudi pediatric populations.
doi:10.1007/s12291-012-0195-x
PMCID: PMC3358380  PMID: 23542765
Glucose; Lipids; Reference intervals; Children
12.  Prevalence of Self-reported Cardiovascular Risk Factors among Saudi Physicians: A Comparative Study 
Background
Cardiovascular disease (CVD) is a leading cause of death worldwide. CVD-related mortality can be substantially reduced by modifying risk factors.
Methods
In this cross-sectional study conducted in King Abdulaziz Medical City, Riyadh, we estimated and compared prevalence of self-reported risk factors for CVD among physicians and a comparative group of non-physician health workers. We postulated that prevalence of CVD risk factors would be significantly lower in physicians. Participants filled in a structured self-administered questionnaire on CVD risk factors.
Results
The study included 200 participants (100 respondents each group). Participants in the two groups were of similar age (P = 0.46) and Body Mass Index (BMI) P = 0.11. There was no statistical difference in smoking, frequency and length of physical exercise per week (P = 0.53, 0.57, 0.47 respectively). Diet habits showed daily intake of more protein, less fat and highly processed food, and similar vegetables, fruit and carbohydrate among physicians. Health status (presence of hypertension, diabetes, or dyslipidemia, or other diseases) didn’t differ between the two groups. Physicians showed a significantly higher familial cardiovascular risk, with mothers and siblings having more dyslipidemia, but there was no significant difference in parental dyslipidemia, diabetes or hypertension.
Conclusion
These findings indicate that high awareness of CVD and associated risk factors alone is not enough to prevent their occurrence. Programs to routinely screen these risk factors and improve the lifestyle of physicians are needed.
PMCID: PMC3612413  PMID: 23559900
Cardiovascular disease; risk factors; physicians; Saudi Arabia
13.  HURT (Headache Under-Response to Treatment) questionnaire in the management of primary headache disorders: reliability, validity and clinical utility of the Arabic version 
Background
To support better headache management in primary care, the Global Campaign against Headache developed an 8-question outcome measure, the Headache Under-Response to Treatment (HURT) questionnaire. HURT was designed by an expert consensus group with patient-input. It assesses the need for and response to treatment, and provides guidance on actions to optimize therapy. It has proven content validity.
We aim to evaluate the Arabic version of HURT for clinical utility in primary care in Saudi Arabia.
Methods
HURT was translated according to the Global Campaign’s translation protocol. We assessed test-retest reliability in consecutive patients of four primary-care centres, who completed HURT at two visits 4-6 weeks apart while receiving usual care. We then provided training in headache management to the GPs practising in these centres, which were randomized in pairs to control (standard care) or intervention (care guided by implementation of HURT). We assessed responsiveness of HURT to clinical change by comparing base-line responses to HURT questions 1-6 with those at follow up. We assessed clinical utility by comparing outcomes between control and intervention pairs after 3 months, using locally-developed 5-point verbal-rating scales: the patient-satisfaction scale (PSS) and doctor-satisfaction scale (DSS).
Results
For test-retest reliability in 40 patients, intra-class correlation coefficients were 0.66-0.78 for questions 1-4 and 0.90-0.93 for questions 5-7 (all P ≤ 0.001). For the dichotomous response to question 8, Kappa coefficient = 1 (P < 0.0001). Internal consistency was good (Cronbach’s alpha = 0.74). In 342 patients, HURT signalled clinical improvement over 3 months through statistically significant changes in responses to questions 1-6. PSS scores were higher among those in whom HURT recorded improvement, and also higher among those with less severe headache at baseline. Patients treated with guidance from HURT (n = 207) were more satisfied than controls (n = 135), but this did not quite reach statistical significance (P = 0.06).
Conclusion
The Arabic HURT Questionnaire is reliable and responsive to clinical change in Arabic-speaking headache patients in primary care. HURT showed clinical utility in this first assessment, conducted in parallel with studies elsewhere in other languages, but this needs further study. Other Arabic instruments are not available as standards for comparison.
doi:10.1186/1129-2377-14-16
PMCID: PMC3620405  PMID: 23565801
Headache; Management; HURT questionnaire; Primary care; Reliability; Validation; Global campaign against headache
14.  Constructing a question bank based on script concordance approach as a novel assessment methodology in surgical education 
BMC Medical Education  2012;12:100.
Background
Script Concordance Test (SCT) is a new assessment tool that reliably assesses clinical reasoning skills. Previous descriptions of developing SCT-question banks were merely subjective. This study addresses two gaps in the literature: 1) conducting the first phase of a multistep validation process of SCT in Plastic Surgery, and 2) providing an objective methodology to construct a question bank based on SCT.
Methods
After developing a test blueprint, 52 test items were written. Five validation questions were developed and a validation survey was established online. Seven reviewers were asked to answer this survey. They were recruited from two countries, Saudi Arabia and Canada, to improve the test’s external validity. Their ratings were transformed into percentages. Analysis was performed to compare reviewers’ ratings by looking at correlations, ranges, means, medians, and overall scores.
Results
Scores of reviewers’ ratings were between 76% and 95% (mean 86% ± 5). We found poor correlations between reviewers (Pearson’s: +0.38 to −0.22). Ratings of individual validation questions ranged between 0 and 4 (on a scale 1–5). Means and medians of these ranges were computed for each test item (mean: 0.8 to 2.4; median: 1 to 3). A subset of test items comprising 27 items was generated based on a set of inclusion and exclusion criteria.
Conclusion
This study proposes an objective methodology for validation of SCT-question bank. Analysis of validation survey is done from all angles, i.e., reviewers, validation questions, and test items. Finally, a subset of test items is generated based on a set of criteria.
doi:10.1186/1472-6920-12-100
PMCID: PMC3533982  PMID: 23095569
Plastic surgery; Script concordance approach; Question bank; Surgical education
15.  Permissive underfeeding versus target enteral feeding in adult critically ill patients (PermiT Trial): a study protocol of a multicenter randomized controlled trial 
Trials  2012;13:191.
Background
Nutritional support is an essential part of the management of critically ill patients. However, optimal caloric intake has not been systematically evaluated. We aim to compare two strategies of enteral feeding: permissive underfeeding versus target feeding.
Method/Design
This is an international multi-center randomized controlled trial in critically ill medical- surgical adult patients. Using a centralized allocation, 862 patients will be randomized to permissive underfeeding or target feeding. Patients in the permissive group receive 50% (acceptable range is 40% to 60%) of the calculated caloric requirement, while those in the targeted group receive 100% (acceptable range 70% to 100%) of the calculated caloric requirement. The primary outcome is 90-day all-cause mortality. Secondary outcomes include ICU and hospital mortality, 28-day, and 180-day mortality as well as health care-associated infections, organ failure, and length of stay in the ICU and hospital. The trial has 80% power to detect an 8% absolute reduction in 90-day mortality assuming a baseline risk of death of 25% at an alpha level of 0.05.
Discussion
Patient recruitment started in November 2009 and is currently active in five centers. The Data Monitoring Committee advised continuation of the trial after the first interim analysis. The study is expected to finish by November 2013.
Trial registration
Current Controlled Trials ISRCTN68144998
doi:10.1186/1745-6215-13-191
PMCID: PMC3517534  PMID: 23057605
Enteral nutrition; Intensive Care Units; Caloric restriction; Infections; Insulin; Mortality
16.  Intra-abdominal pressure and abdominal perfusion pressure in cirrhotic patients with septic shock 
Annals of Intensive Care  2012;2(Suppl 1):S4.
Background
The importance of intra-abdominal pressure (IAP) and abdominal perfusion pressure (APP) in cirrhotic patients with septic shock is not well studied. We evaluated the relationship between IAP and APP and outcomes of cirrhotic septic patients, and assessed the ability of these measures compared to other common resuscitative endpoints to differentiate survivors from nonsurvivors.
Methods
This study was a post hoc analysis of a randomized double-blind placebo-controlled trial in which mean arterial pressure (MAP), central venous oxygen saturation (ScvO2) and IAP were measured every 6 h in 61 cirrhotic septic patients admitted to the intensive care unit. APP was calculated as MAP - IAP. Intra-abdominal hypertension (IAH) was defined as mean IAP ≥ 12 mmHg, and abdominal hypoperfusion as mean APP < 60 mmHg. Measured outcomes included ICU and hospital mortality, need for renal replacement therapy (RRT) and ventilator- and vasopressor-free days.
Results
IAH prevalence on the first ICU day was 82%, and incidence in the first 7 days was 97%. Compared to patients with normal IAP, IAH patients had significantly higher ICU mortality (74.0% vs. 27.3%, p = 0.005), required more RRT (78.0% vs. 45.5%, p = 0.06) and had lower ventilator- and vasopressor-free days. On a multivariate logistic regression analysis, IAH was an independent predictor of both ICU mortality (odds ratio (OR), 12.20; 95% confidence interval (CI), 1.92 to 77.31, p = 0.008) and need for RRT (OR, 6.78; 95% CI, 1.29 to 35.70, p = 0.02). Using receiver operating characteristic curves, IAP (area under the curve (AUC) = 0.74, p = 0.004), APP (AUC = 0.71, p = 0.01), Acute Physiology and Chronic Health Evaluation II score (AUC = 0.71, p = 0.02), but not MAP, differentiated survivors from nonsurvivors.
Conclusions
IAH is highly prevalent in cirrhotic patients with septic shock and is associated with increased ICU morbidity and mortality.
doi:10.1186/2110-5820-2-S1-S4
PMCID: PMC3390301  PMID: 22873420
liver cirrhosis; sepsis; compartment syndrome; septic shock; ascites; mortality.
17.  MMP1-1607(1G>2G) polymorphism and the risk of lung cancer in Lebanon 
Annals of Thoracic Medicine  2012;7(3):130-132.
CONTEXT:
Matrix metalloproteinases (MMPs) are a family of enzymes that degrade various components of the extracellular matrix and are involved in the development and progression of cancer. Lung cancer is the most commonly diagnosed cancer in Lebanon. MMP1 is responsible for degrading stromal collagens, which enhance the ability of neoplastic cells to cross basal membrane of both the endothelium and the vascular endothelium. A recent meta-analysis has suggested that the MMP1-1607 2G allele may be associated with an increased risk for certain types of cancers.
AIM:
This study was undertaken to investigate the association between guanine insertion polymorphism in the MMP1 promoter and the susceptibility to lung cancer in the Lebanese population.
SETTINGS AND DESIGN:
This case-control study was conducted on 41 patients with lung cancer and 51 age-matched healthy controls, recruited from different regions of Lebanon.
METHODS:
Cases were histologically confirmed lung cancer patients obtained from different hospitals in Lebanon. Controls were healthy unrelated individuals with no history of cancer or genetic diseases. All subjects were genotyped for MMP1 -1607(1G>2G) polymorphism using polymerase chain reaction-restriction fragment length polymorphism method (PCR-RFLP).
RESULTS:
No statistically significant differences were found when genotype and allele distribution of MMP1 -1607(1G>2G) polymorphism were compared between patients with lung cancer and controls [P= 0.6 by chi-squared test on a 3×2 contingency table; allelic P=0.61, OR (95% CI) = 1.18 (0.60-2.31)].
CONCLUSION:
Our data shows that MMP1 promoter polymorphism is not associated with lung cancer susceptibility in the Lebanese population.
doi:10.4103/1817-1737.98844
PMCID: PMC3425043  PMID: 22924069
Lebanon; lung cancer; MMP1; polymorphism
18.  Age and BMI Adjusted Comparison of Reproductive Hormones in PCOS 
Objective and Background:
Polycystic ovary syndrome (PCOS) is a complex condition and has been described in women who have polycystic ovaries as the underlying cause of hirsutism and chronic anovulation. Studies on PCOS in the Saudi population are very few. The aim of this study was to investigate the reproductive hormones levels in patients with PCOS. Effect of age and body mass index (BMI) on the hormonal findings was eliminated through a multivariate analysis.
Materials and Methods:
A comparative study was conducted on Saudi subjects attending the outpatient clinic of National Guard Hospital in Riyadh. A total of 62 cases with PCOS and 40 healthy Saudi women were included in this study. Physical evaluation and laboratory investigations were carried out. Blood luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol (E2), dehydroepiandrosterone sulfate (DHEA-SO4), sex hormone-binding globulin (SHBG), total testosterone, prolactin, and progesterone were determined. To adjust for the potentially confounding effect of age and BMI, we carried out multivariate linear regression analyses for the association between each of the reproductive hormones and PCOS.
Results:
Serum levels of FSH, SHBG, and progesterone were significantly lower in PCOS compared to controls (respective P values 0.001, 0.001, and 0.002), while LH/FSH and testosterone levels were higher in PCOS cases than in controls (P = 0.008 and 0.003, respectively). When multivariate linear regression analyses were carried out, LH/FSH and total testosterone were positively correlated with the disease [95% confidence interval (CI) = 0.02–0.35 and 0.02–0.17, respectively], whereas FSH, SHBG, and progesterone were negatively correlated with the disease (95% CI = –0.06 to 0.001, –0.01 to 0.001, and –0.17 to –0.03, respectively), independent of age and BMI.
Conclusion:
Our study suggests that regardless of the age and weight factors, Saudi patients with PCOS have higher levels of LH/FSH and total testosterone; but have lower levels of FSH, SHBG, and progesterone compared to controls.
doi:10.4103/2249-4863.104984
PMCID: PMC3893977  PMID: 24479022
Age; body mass index; polycystic ovary syndrome; reproductive hormones; Saudi Arabia
19.  Integration of evidence based medicine into the clinical years of a medical curriculum 
Teaching Evidence Based Medicine (EBM) helps medical students to develop their decision making skills based on current best evidence, especially when it is taught in a clinical context. Few medical schools integrate Evidence Based Medicine into undergraduate curriculum, and those who do so, do it at the academic years only as a standalone (classroom) teaching but not at the clinical years. The College of Medicine at King Saud bin Abdulaziz University for Health Sciences was established in January 2004. The college adopted a four-year Problem Based Learning web-based curriculum. The objective of this paper is to present our experience in the integration of the EBM in the clinical phase of the medical curriculum. We teach EBM in 3 steps: first step is teaching EBM concepts and principles, second is teaching the appraisal and search skills, and the last step is teaching it in clinical rotations. Teaching EBM at clinical years consists of 4 student-centered tutorials. In conclusion, EBM may be taught in a systematic, patient centered approach at clinical rounds. This paper could serve as a model of Evidence Based Medicine integration into the clinical phase of a medical curriculum.
doi:10.4103/2230-8229.98307
PMCID: PMC3410178  PMID: 22870419
Clinical years; evidence based medicine; medical curriculum; medical education
20.  Utilization and responsiveness of the asthma control test (ACT) at the initiation of therapy for patients with asthma: a randomized controlled trial 
Background
The aim of this study was to assess the responsiveness of the asthma control test (ACT) to detect changes at the initiation of therapy and its utilization in the initiation of asthma treatment.
Methods
This study was designed as a randomized clinical trial conducted in a primary care setting. The subjects were asthma patients who had not received controller therapy for at least two months. The patients were randomized into two groups: The Saudi Initiative for Asthma (SINA) group and the Global Initiative for Asthma (GINA) group. Treatment in the SINA group was initiated at step1 when the ACT scores ≥ 20, step 2 when the score between16-19, and step 3 when the score < 16 began at step 3. The GINA group patients were started on step 2 when they had persistent asthma symptoms or step 3 when they had severely uncontrolled disease.
Results
Forty-five patients were analyzed in each group. The improvement in ACT score after treatment initiation was significantly higher when the SINA approach was used (2.9 in the SINA group compared to 1.7 in the GINA group (p = 0.04)). The improvement in FEV1 was 5.8% in the SINA group compared to 3.4% in the GINA group (p = 0.46). The number of patients who achieved asthma control at the follow-up visit and required no treatment adjustment was 33 (73.3%) in the SINA group and 27 (60%) in the GINA group (p = 0.0125).
Conclusion
The ACT was responsive to change at the initiation of asthma treatment and was useful for the initiation of asthma treatment.
Trial Registration number
ISRCTN31998214
doi:10.1186/1471-2466-12-14
PMCID: PMC3359228  PMID: 22449144
Asthma; Asthma control test; Guidelines; Global initiative for asthma; Saudi initiative for asthma; Control
21.  Etomidate and mortality in cirrhotic patients with septic shock 
Background
Clinical effects and outcomes of a single dose etomidate prior to intubation in the intensive care setting is controversial. The aim of this study is to evaluate the association of a single dose effect of etomidate prior to intubation on the mortality of septic cirrhotic patients and the impact of the subsequent use of low dose hydrocortisone.
Methods
This is a nested-cohort study within a randomized double blind placebo controlled study evaluating the use of low dose hydrocortisone in cirrhotic septic patients. Cirrhotic septic patients ≥ 18 years were included in the study. Patients who received etomidate prior to intubation were compared to those who did not receive etomidate for all cause 28-day mortality as a primary outcome.
Results
Sixty two intubated patients out of the 75 patients randomized in the initial trial were eligible for this study. Twenty three of the 62 intubated patients received etomidate dose prior to intubation. Etomidate use was not associated with all cause 28-day mortality or hospital mortality but was associated with significantly higher ICU mortality (91% vs. 64% for etomidate and controls groups, respectively; p = 0.02). Etomidate patients who received subsequent doses of hydrocortisone required lower doses of vasopressors and had more vasopressor-free days but no improvement in mortality.
Conclusions
In this group of septic cirrhotic patients with very high mortality, etomidate increased ICU mortality. Subsequent use of hydrocortisone appears to have no benefit beyond decreasing vasopressor requirements. The lowest mortality was observed in patients who did not receive etomidate but received hydrocortisone.
doi:10.1186/1472-6904-11-22
PMCID: PMC3295685  PMID: 22208901
22.  Impact of computerized physician order entry (CPOE) system on the outcome of critically ill adult patients: a before-after study 
Background
Computerized physician order entry (CPOE) systems are recommended to improve patient safety and outcomes. However, their effectiveness has been questioned. Our objective was to evaluate the impact of CPOE implementation on the outcome of critically ill patients.
Methods
This was an observational before-after study carried out in a 21-bed medical and surgical intensive care unit (ICU) of a tertiary care center. It included all patients admitted to the ICU in the 24 months pre- and 12 months post-CPOE (Misys®) implementation. Data were extracted from a prospectively collected ICU database and included: demographics, Acute Physiology and Chronic Health Evaluation (APACHE) II score, admission diagnosis and comorbid conditions. Outcomes compared in different pre- and post-CPOE periods included: ICU and hospital mortality, duration of mechanical ventilation, and ICU and hospital length of stay. These outcomes were also compared in selected high risk subgroups of patients (age 12-17 years, traumatic brain injury, admission diagnosis of sepsis and admission APACHE II > 23). Multivariate analysis was used to adjust for imbalances in baseline characteristics and selected clinically relevant variables.
Results
There were 1638 and 898 patients admitted to the ICU in the specified pre- and post-CPOE periods, respectively (age = 52 ± 22 vs. 52 ± 21 years, p = 0.74; APACHE II = 24 ± 9 vs. 24 ± 10, p = 0.83). During these periods, there were no differences in ICU (adjusted odds ratio (aOR) 0.98, 95% confidence interval [CI] 0.7-1.3) and in hospital mortality (aOR 1.00, 95% CI 0.8-1.3). CPOE implementation was associated with similar duration of mechanical ventilation and of stay in the ICU and hospital. There was no increased mortality or stay in the high risk subgroups after CPOE implementation.
Conclusions
The implementation of CPOE in an adult medical surgical ICU resulted in no improvement in patient outcomes in the immediate phase and up to 12 months after implementation.
doi:10.1186/1472-6947-11-71
PMCID: PMC3248372  PMID: 22098683
Intensive care unit; critical illness; CPOE; safety management; mortality; morbidity
23.  What is the optimal blood glucose target in critically ill patients? A nested cohort study 
Annals of Thoracic Medicine  2011;6(4):207-211.
AIMS:
There is an uncertainty about what constitutes an optimal level of blood glucose (BG) in critically ill patients. The objective of this study is to identify the optimal BG target for glycemic control in critically ill patients that is associated with survival benefit with the least hypoglycemia risk.
SETTING AND DESIGN:
This is a nested cohort study within a randomized control trial conducted in a tertiary care center in King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia.
METHODS:
The study was carried out in a single center to assess the effect of intensive insulin therapy [IIT; target BG 4.4-6.1 mmol/L (80-110 mg/dL)] versus conventional insulin therapy [CIT; target BG 10-11.1 mmol/L (180-200 mg/dL)] in a medical/surgical ICU. All patients were divided into six groups based on the mean daily BG levels. A logistic regression model was used to determine the association of BG and ICU mortality. We compared different outcomes below and above different BG thresholds of 0.1 mmol/L (2 mg/dL) increments using multivariate analyses.
STATISTICAL ANALYSIS:
Data are presented as mean ± SD or median with interquartile ranges, unless otherwise indicated. Differences between the six groups were assessed using the χ2 test. A P-value equal or less than 0.05 was considered to indicate statistical significance. The results were expressed as adjusted odds ratio (aOR) and 95% confidence intervals (CI). Statistical analyses were carried out using the Statistical Analysis Software (SAS, release 8, SAS Institute Inc., Cary, NC, USA).
RESULTS:
Among six groups, the ICU mortality was least in patients with BG <8.7 mmol/L (<157 mg/dL) compared with patients with BG ≥8.7 mmol/L (≥157 mg/dL) [11.5% vs. 21.5%, P = 0.002]. When analyzed using 0.1 mmol increments in average BG, we found that mortality remained unchanged by increasing thresholds of BG up to 8.0 mmol/L (144 mg/dL) and started to rise with thresholds of BG of 8.1 mmol/L (146 mg/dL) and above. The risk of hypoglycemia was the highest with a BG threshold of 6.1 mmol/L (110 mg/dL) and gradually decreased with increasing BG levels to plateau with a BG level of 7.2 mmol/L (130 mg/dL) and higher.
CONCLUSION:
Our study suggests that a BG level of 8.1 mmol/L (146 mg/dL) and below represents an optimal level in critically ill patients.
doi:10.4103/1817-1737.84774
PMCID: PMC3183637  PMID: 21977065
Critically ill; hypoglycemia; insulin; intensive care; mortality; sepsis
24.  Inpatients’ care experience and satisfaction study 
Objective and Background:
Measures to promote patient satisfaction are important components of the assessment of outcome and strategies for the delivery of health care. In this article, we assess satisfaction among inpatients and the impact of demographics on satisfaction levels.
Materials and Methods:
This cross-sectional survey adapted from previously used survey tools and validated in our patient group included questions on demographics, communication skills, hospital environment, and the patients’ overall evaluation of the hospital. Inpatients from acute wards of five different specialties who stayed for at least 2 days were enrolled.
Results:
There were 988 respondents with a mean age of 39.1 years (25.9%) and the mean length of stay (LOS) of 10.0 days (24.1%). Illiteracy rate was 42.4%, and 43.1% were male. The overall satisfaction scores—out of five—were 4.3 (0.6%) for communication with nurses, 4.4 (0.4%) for communication with doctors, and 4.1 (0.3%) for hospital environment; 98.9% of the patients would recommend the hospital to their family and friends. The lowest score was for the “room environment” (3.99, 0.8%) and the highest for overall services of the hospital (4.7, 0.5%). Satisfaction levels drop significantly with LOS of more than 4 days (P < 0.006). The satisfaction was higher in females than males across all the three domains of care assessed (P < 0.005). The highest satisfaction seen in the obstetrics service could be explained by the nature of the condition normally seen in this department and the normally good outcome. There was higher satisfaction in the medical than surgical services but this reached a significant level for the overall center score domain only (4.1, 0.3% versus 4.0, 0.3%; P < 0.0001).
Conclusion:
The factors with positive impact on satisfaction were the female gender and shorter LOS. There was higher satisfaction in the medical than surgical services for all three domains reaching significant levels for center score only.
doi:10.4103/2230-8229.90009
PMCID: PMC3237198  PMID: 22175037
Patient satisfaction; Saudi Arabia
25.  Association between statin therapy and outcomes in critically ill patients: a nested cohort study 
Background
The effect of statin therapy on mortality in critically ill patients is controversial, with some studies suggesting a benefit and others suggesting no benefit or even potential harm. The objective of this study was to evaluate the association between statin therapy during intensive care unit (ICU) admission and all-cause mortality in critically ill patients.
Methods
This was a nested cohort study within two randomised controlled trials conducted in a tertiary care ICU. All 763 patients who participated in the two trials were included in this study. Of these, 107 patients (14%) received statins during their ICU stay. The primary endpoint was all-cause ICU and hospital mortality. Secondary endpoints included the development of sepsis and severe sepsis during the ICU stay, the ICU length of stay, the hospital length of stay, and the duration of mechanical ventilation. Multivariate logistic regression was used to adjust for clinically and statistically relevant variables.
Results
Statin therapy was associated with a reduction in hospital mortality (adjusted odds ratio [aOR] = 0.60, 95% confidence interval [CI] 0.36-0.99). Statin therapy was associated with lower hospital mortality in the following groups: patients >58 years of age (aOR = 0.58, 95% CI 0.35-0.97), those with an acute physiology and chronic health evaluation (APACHE II) score >22 (aOR = 0.54, 95% CI 0.31-0.96), diabetic patients (aOR = 0.52, 95% CI 0.30-0.90), patients on vasopressor therapy (aOR = 0.53, 95% CI 0.29-0.97), those admitted with severe sepsis (aOR = 0.22, 95% CI 0.07-0.66), patients with creatinine ≤100 μmol/L (aOR = 0.14, 95% CI 0.04-0.51), and patients with GCS ≤9 (aOR = 0.34, 95% CI 0.17-0.71). When stratified by statin dose, the mortality reduction was mainly observed with statin equipotent doses ≥40 mg of simvastatin (aOR = 0.53, 95% CI 0.28-1.00). Mortality reduction was observed with simvastatin (aOR = 0.37, 95% CI 0.17-0.81) but not with atorvastatin (aOR = 0.80, 95% CI 0.84-1.46). Statin therapy was not associated with a difference in any of the secondary outcomes.
Conclusion
Statin therapy during ICU stay was associated with a reduction in all-cause hospital mortality. This association was especially noted in high-risk subgroups. This potential benefit needs to be validated in a randomised, controlled trial.
doi:10.1186/1472-6904-11-12
PMCID: PMC3199769  PMID: 21819615

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