Publications by authors named "Ghassan Sleilaty"

87 Publications

Mobile sonouroflowmetry using voiding sound and volume.

Sci Rep 2021 May 27;11(1):11250. Epub 2021 May 27.

Global Center for Medical Engineering and Informatics, Osaka University, Osaka, Japan.

Uroflowmetry (UF) is a common clinic-based non-invasive test to diagnose Lower Urinary Tract Dysfunction (LUTD). Accurate home-based uroflowmetry methods are needed to conveniently conduct repeated uroflowmetries when patients are physiologically ready to urinate. To this end, we propose and evaluate a novel mobile sonouroflowmetry (SUF) method that estimates the urinary flow rate from a sound signal recorded using a mobile phone. By linearly mapping the total sound energy to the total voided volume, the sound energy curve is transformed to a flow rate curve allowing the estimation of the flow rate over time. An evaluation using data from 44 healthy young men showed high similarity between the UF and SUF flow rates with a mixed-effects model correlation coefficient of 0.993 and a mean root mean square error of 2.37 ml/s. Maximum flow rates were estimated with an average absolute error of 2.41 ml/s. Future work on mobile uroflowmetry can use these results as an initial benchmark for flow rate estimation accuracy.
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http://dx.doi.org/10.1038/s41598-021-90659-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8159949PMC
May 2021

Is Machine Learning-derived Low-Density Lipoprotein Cholesterol estimation more reliable than standard closed form equations? Insights from a laboratory database by comparison with a direct homogeneous assay.

Clin Chim Acta 2021 Aug 13;519:220-226. Epub 2021 May 13.

Clinical Research Center, Hôtel Dieu de France and Faculty of Medicine, Université Saint Joseph, Beirut, Lebanon.

Background: There is no consensus on the best method to estimate Low Density Lipoprotein-Cholesterol (LDL-C) in routine laboratories.

Methods: We conducted a retrospective study to compare the performances of a Machine Learning (ML) algorithm using the K-Nearest Neighbors (LDL-KNN) method with that of the Friedewald formula (LDL-F), the Martin-Hopkins equation (LDL-NF), the de Cordova equation (LDL-CO) and the Sampson equation (LDL-SA) against direct homogeneous LDL-C assay (LDL-D) in patients who presented to the Laboratories of Hôtel Dieu de France university hospital in Beirut, Lebanon, from September 2017 to July 2020. Agreements between methods were analyzed using Intraclass Correlation Coefficients (ICC) and the Bland-Altman method of agreement.

Results: 31,922 observations from 19,279 subjects were included, with a mean age of 52 ± 18 years and 10,075 (52.3%) females. All methods except LDL-F and LDL-CO exhibited an overall ICC beyond the 0.9 cut-off. LDL-SA, LDL-NF and LDL-KNN were less susceptible to triglyceridemia than LDL-F and LDL-CO, with LDL-KNN resulting in the lesser fraction of points beyond the Bland-Altman limits of agreement.

Conclusion: An ML algorithm using LDL-KNN is promising for the estimation of LDL-C as it agrees better with LDL-D than closed form equations, especially in mild and severe hypertriglyceridemia.
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http://dx.doi.org/10.1016/j.cca.2021.05.008DOI Listing
August 2021

Do age-adjusted sex-specific cut-off values improve the agreement between high sensitivity cardiac troponins I and T? A retrospective study.

Clin Chim Acta 2021 Aug 15;519:76-82. Epub 2021 Apr 15.

Clinical Research Center, Hôtel-Dieu de France and Faculty of Medicine, Université Saint-Joseph, Beirut, Lebanon.

Background: Many reports noted a disagreement between High sensitivity cardiac Troponin (hs-cTn) assays on the diagnosis of Acute Coronary Syndrome (ACS).

Methods: We conducted a retrospective study aiming to assess the agreement between hs-cTn T (Roche) and hs-cTn I (Abbott) in patients presenting with a suspected ACS to the emergency department at Hotel-Dieu hospital between September 2017 and October 2019 using overall, sex-specific, and age-adjusted sex-specific cut-off values. This was measured using Cohen's Kappa. We explored whether renal function, circadian rhythm, age and sex influenced the discordance. And we analyzed the trend of agreement between baseline and repeated measurements.

Results: 4856 patients who had simultaneous hs-cTn I and T values were retained for the analysis. 53.5% had a hs-cTn T above the overall 99th percentile, compared to 19.9% for hs-cTn I. The numbers were significantly reduced when applying age-adjusted sex-specific 99th percentile. A disagreement was seen in 34% of cases using overall 99th percentile. Using sex-specific cut off values did not impact this discordance; however, age-adjusted sex-specific cut-off values reduced the percentage of discrepancies to 15.8%. The decreased renal function had a negative effect on the agreement while the circadian rhythm had minimal effect. This initial discordance was carried forward into repeated measurements.

Conclusion: The disagreement between hs-cTn T and I assays could be imputed to the choice of cut-off values. The use of age-adjusted sex specific 99th percentile reduced majorly these discordances. Further studies are needed in order to evaluate their clinical utility in patients presenting with ACS.
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http://dx.doi.org/10.1016/j.cca.2021.04.007DOI Listing
August 2021

Effects of Caffeinated and Decaffeinated Coffee on Hemodialysis-Related Headache (CoffeeHD): A Randomized Multicenter Clinical Trial.

J Ren Nutr 2021 Mar 12. Epub 2021 Mar 12.

Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon; Department of Nephrology, Hôtel-Dieu de France Hospital, Beirut, Lebanon.

Objectives: Historically, headache was reported in up to 76% of hemodialysis patients. Some authors suggested that headache resulted from caffeine withdrawal. This study aims to compare the incidence of headache and hypotension between patients drinking regular or decaffeinated coffee during dialysis.

Methods: One-hundred fifty-six patients were enrolled in this randomized, double-blind, placebo-controlled, multicenter study. Patients with atrial fibrillation were excluded. Group A was given 80 mL of regular coffee and group B 80 mL of decaffeinated coffee (placebo) in the middle of the session for 12 consecutive sessions. Ultrafiltration rate was fixed to a maximum of 13 mL/kg/hour. The primary outcome was the incidence of headache during dialysis.

Results: A total of 139 patients completed the trial (6.4% vs. 15.4% of withdrawal in Groups A and B, respectively). The number of sessions with headache was not significantly different between Group A and B (33.3% vs. 37.1% respectively, P = .522), nor the number of sessions with hypotension (27% vs. 26% respectively, P = .539). In a subgroup analysis, headache tended to be more frequent in Group B (P = .06) in 2 categories of patients: those with the highest potassium dialysate (K = 2) and the non-hypertensive patients.

Conclusions: Headache occurred in 35% of patients during their chronic hemodialysis sessions. Caffeine intake did not prevent headache occurrence in these patients.
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http://dx.doi.org/10.1053/j.jrn.2021.01.025DOI Listing
March 2021

Validity and reliability of an Arabic version of the Sleep Hygiene Index.

Sleep Med 2021 Apr 3;80:260-264. Epub 2021 Feb 3.

Neurology Department, Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon. Electronic address:

Aim: this study aims to assess the reliability and validity of an Arabic version of the Sleep Hygiene Index (SHI).

Methods: A methodological study was carried out in four stages: initial translation by 2 professional translators, evaluation and synthesis of the initial translation by project managers, back-translation and validation. The Arabic (SHI-AR) and English (SHI-ENG) versions of the SHI were administered across Lebanon as an anonymous online survey in April 2020. Internal consistency of the SHI-AR and inter-rater reliability were assessed by calculating Cronbach alpha (α) and Intraclass Correlation Coefficient (ICC) respectively. Inter-rater agreement for each item of the SHI was measured using Cohen's Kappa coefficient. Construct validity was investigated by exploratory factor analysis (EFA).

Results: 363 participants were enrolled in the study (129 men, 234 women, mean age 30 ± 11 years). There was no statistically significant difference between mean overall scores on the 2 versions of the SHI with mean scores of 19.16 ± 7.4 and 19.25 ± 7.6 on SHI-AR and SHI-ENG respectively (p = 0.265). Internal consistency was satisfactory (α = 0.749), and the inter-rater agreement for the total scores of the 2 versions of the SHI was excellent (ICC = 0.980). All items of the SHI showed substantial to high level of agreement between the 2 versions. EFA established four factors underlying the questionnaire.

Conclusion: The Arabic version of the SHI is a valid tool to assess sleep hygiene in Arabic speaking populations.
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http://dx.doi.org/10.1016/j.sleep.2021.01.040DOI Listing
April 2021

Prevalence and status of Lipoprotein (a) among Lebanese school children.

Sci Rep 2020 11 26;10(1):20620. Epub 2020 Nov 26.

Department of Biostatistics and Clinical Research Center, Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon.

Lipoprotein a (Lp(a) is an independent risk factor for atherosclerotic cardiovascular disease. The prevalence of high Lipoprotein (a) (Lp(a)) in the Lebanese pediatric population is unknown. Our study aims to assess this prevalence and to study the relationship of Lp(a) with the lipid profile, age, body mass index (BMI) and socio-economic status (SES) in Lebanese schoolchildren. A total of 961 children aged 8-18 years (497 boys and 464 girls) were recruited from ten private and public schools in 2013-2014 using a stratified random sample. Schools were selected from the Greater Beirut and Mount Lebanon areas, and were categorized into three subgroups according to the schools' SES status (high, medium, low). Lp(a) was assayed in 2018 on samples previously frozen at - 80 °C. Abnormal Lp(a) levels (≥ 75 nmol/L) were observed in 14.4% of the overall sample (13.5% for boys,15.3% of girls p = 0.56). The median of Lp(a) was 20(10-50) in the whole sample with no significant gender difference. No significant relationship was found between Lp(a) and age. However, Lp(a) was significantly correlated with BMI in whole sample, as well as in boys and girls (p = 0.02, p = 0.03, p = 0.03, respectively). A significant correlation was found between Lp(a) and non-HDL-C in the whole sample as well as in boys and girls (respectively p < 0.001,p = 0.024 and p = 0.03), but not with triglycerides and HDL-C. In a multivariate linear regression analysis, Lp(a) was only independently associated with BMI and non-HDL-C in boys and girls. Lp(a) was independently associated with BMI and non-HDL-C while no significant relationship was observed with age and sex confirming the strong genetic determination of Lp(a).
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http://dx.doi.org/10.1038/s41598-020-77689-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692560PMC
November 2020

Preprocedure CT Findings of Right Heart Failure as a Predictor of Mortality After Transcatheter Aortic Valve Replacement.

AJR Am J Roentgenol 2021 01 10;216(1):57-65. Epub 2020 Nov 10.

Department of Radiology, University of Maryland School of Medicine, 22 S Green St, Baltimore, MD 21201.

Objective: The purpose of this study is to determine whether imaging features of right heart failure seen on CT performed before transcatheter aorta valve replacement (TAVR) predict poor outcomes after the procedure.

Materials And Methods: We retrospectively evaluated findings on CT performed before TAVR for 505 consecutive patients seen from 2014 to 2018. Of these patients, 300 underwent TAVR. Patient demographic characteristics and clinical and procedural data were recorded. Imaging features, including signs of right heart failure, left heart failure, lung disease, coronary artery disease, and concomitant mitral valve and apparatus calcifications were evaluated. The primary outcome was all-cause mortality at 1 year after TAVR. Patients were divided into two groups: those who were alive (group 1) and those who had died (group 2) by 1 year after TAVR. These groups were compared using the Mann-Whitney test and the Pearson chi-square and Fisher exact tests when applicable. Multivariate logistic regression with a backward stepwise approach was performed. Results were correlated with echo-cardiography findings.

Results: A total of 31 patients (10.3%) died within 1 year of TAVR. The presence and size of pericardial effusions were strongly associated with mortality within 1 year after TAVR ( = 0.002). Pericardial effusion was noted in 25 patients in group 1 (9.3%) and eight patients in group 2 (25.8%). Increased size of the main pulmonary artery was associated with death ( = 0.024), with a median main pulmonary artery size of 2.9 cm (interquartile range, 2.6-3.3 cm) in group 1 and 3.2 cm (interquartile range, 2.9-3.5 cm) in group 2. In multivariate analysis, pericardial effusion size and pulmonary artery size, both of which are indicative of right heart failure, were predictors of death, independent of the routinely used clinical Society of Thoracic Surgeons score (AUC, 0.758; 95% CI, 0.671-0.845). Depressed right ventricular ejection fraction, as identified on echocardiography, was associated with mortality within 1 year after TAVR ( = 0.034), further corroborating the CT findings.

Conclusion: Features related to right heart failure on pre-TAVR CT were associated with increased all-cause mortality within the first year after TAVR, even after adjustment for the Society of Thoracic Surgeons score. Such imaging findings can help in further risk stratification of patients before TAVR.
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http://dx.doi.org/10.2214/AJR.20.22894DOI Listing
January 2021

The Impact of Retrospective Childhood Maltreatment on Eating Disorders as Mediated by Food Addiction: A Cross-Sectional Study.

Nutrients 2020 Sep 28;12(10). Epub 2020 Sep 28.

PSNREC, University of Montpellier, INSERM, CHU de Montpellier, 34295 Montpellier, France.

Background: The current study aimed to test whether food addiction (FA) might mediate the relationship between the presence of a history of childhood maltreatment and eating disorder (ED) symptom severity.

Methods: Participants were 231 patients with ED presenting between May 2017 and January 2020 to a daycare treatment facility for assessment and management with mainly the Eating Disorder Inventory-2 (EDI-2), the Child Trauma Questionnaire (CTQ), and the Yale Food Addiction Scale (YFAS 2.0).

Results: Participants had a median age of 24 (interquartile range (IQR) 20-33) years and manifested anorexia nervosa (61.47%), bulimia nervosa (16.88%), binge-eating disorders (9.09%), and other types of ED (12.55%). They were grouped into those likely presenting FA ( = 154) and those without FA ( = 77). The group with FA reported higher scores on all five CTQ subscales, as well as the total score of the EDI-2 ( < 0.001). Using mediation analysis; significant indirect pathways between all CTQ subscales and the EDI-2 total score emerged via FA, with the largest indirect effect emerging for physical neglect (standardized effect = 0.208; 95% confidence interval (CI) 0.127-0.29) followed by emotional abuse (standardized effect = 0.183; 95% CI 0.109-0.262).

Conclusion: These results are compatible with a model in which certain types of childhood maltreatment, especially physical neglect, may induce, maintain, and/or exacerbate ED symptoms via FA which may guide future treatments.
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http://dx.doi.org/10.3390/nu12102969DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7601309PMC
September 2020

Functional MRI study of language organization in left-handed and right-handed trilingual subjects.

Sci Rep 2020 08 5;10(1):13165. Epub 2020 Aug 5.

Hotel Dieu de France Hospital, Boulevard Alfred Naccache, Achrafieh, PO Box: 166830, Beirut, Lebanon.

Functional MRI (fMRI) is gaining importance in the preoperative assessment of language. Selecting the appropriate language to test by fMRI in trilingual patients is intricate. Our objective is to compare fMRI maps for all three languages in left- and right-handed trilingual subjects. 15 right- and 15 left-handed trilingual volunteers were included in the study. We performed fMRI for each volunteer with a visual responsive naming paradigm that was repeated three times, once in each language. The activated areas and the laterality indices were calculated and correlation with the age of acquisition and proficiency of each language was determined. Strong statistical correlation was found between the Laterality Index (LI) of the three languages, in both the right and left-handed groups. Discordant lateralization of language was only observed in four left-handed subjects who demonstrated bilateral and left-lateralization. In right-handed subjects, the activation maps for the first and the second acquired language were similar. The largest activation was seen with the last acquired language. Irrespective of language proficiency and age of acquisition, the language lateralization might change for left-handed subjects. In right-handed subjects, there is no change and the last acquired language results in the largest activation. fMRI performed for a single language can accurately determine language lateralization in right-handed subjects, whereas in left-handed subjects, it is mandatory to test all languages.
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http://dx.doi.org/10.1038/s41598-020-70167-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7406510PMC
August 2020

Teaching the use of framing and decontextualization to address context-based bias in psychiatry.

Asian J Psychiatr 2020 Dec 2;54:102276. Epub 2020 Jul 2.

Saint Joseph University, Department of Urology, Beirut, Lebanon.

The framing effect in medical decision making is a type of cognitive bias that can lead a medical trainee at undergraduate and graduate level to reach a diagnosis or take action based on emotional states induced by the frame in which the information has been approached. This literature review on the framing effect in medical decision making will be done in the context of a case presentation in which the framing of scientific information may lead to conflicting decisions in psychiatry. As a matter of fact, debiasing techniques which help medical students/residents become aware of the fact that they might be easily influenced by the frame used in scientific data, have started to be implemented in medical teaching programs. It is important to incorporate exercises that improve debiasing skills in the curriculum at all levels of medical education. An example of such exercises is decontextualization which consists of improving problem-solving in a non-medical context in order to consolidate the use of the same schema of critical thinking in a medical context afterwards.
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http://dx.doi.org/10.1016/j.ajp.2020.102276DOI Listing
December 2020

A formula predicting the effective dose of febuxostat in chronic kidney disease patients with asymptomatic hyperuricemia based on a retrospective study and a validation cohort
.

Clin Nephrol 2020 Aug;94(2):61-69

Aim: Febuxostat is initiated in chronic kidney disease (CKD) patients to lower uric acid but without any renal dosing scheme. This study aimed to determine a formula that predicts the effective dose of febuxostat in patients with an estimated glomerular filtration rate (eGFR) < 60 mL/min and asymptomatic hyperuricemia.

Materials And Methods: This is a retrospective analysis of 100 CKD patients treated with febuxostat for asymptomatic hyperuricemia in two private Lebanese clinics. Patients with gout were excluded. Collected variables were age, sex, weight, serum creatinine, serum uric acid (sUA) before and after febuxostat, dose of febuxostat used, and diuretic use. Multiple regression analysis was used to derive a formula predicting the dose of febuxostat based on eGFR (2009 Chronic Kidney Disease Epidemiology Collaboration equation), baseline sUA, and sUA reduction ratio. A prospective cohort of 24 patients was then used to validate the derived model.

Results: 100 patients were included with a median age of 71.5 years (interquartile range (IQR), 64.2 - 79.0); 69% were men. Median baseline sUA was 9.1 mg/dL (IQR, 8.4 - 10.1). Mean eGFR was 31.80 ± 12.96 mL/min/1.73m. Of the included patients, 18% had CKD stage 3a, 36% had CKD stage 3b, 38% had CKD stage 4, and 8% had non-dialysis CKD stage 5. A formula was computed to predict febuxostat dosing. Variables that were predictive of febuxostat dose and used in the final equation were eGFR, diuretic use, baseline sUA, and sUA reduction ratio. The validation cohort showed no significant difference between the expected sUA and the measured one (p = 0.16).

Conclusion: With this new formula, physicians can initiate febuxostat in CKD patients at an effective dose for any desired sUA reduction ratio.
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http://dx.doi.org/10.5414/CN109867DOI Listing
August 2020

I vitamin D receptor gene polymorphism and serum 25-hydroxyvitamin D in patients with cardiovascular risk.

Arch Med Sci Atheroscler Dis 2019 31;4:e298-e303. Epub 2019 Dec 31.

Research Laboratory in Physiology and Physiopathology (LRPP), Health Technology Centre, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.

Introduction: The biological actions of vitamin D are mediated through vitamin D receptor (VDR). Numerous single-nucleotide polymorphisms (SNPs) in the VDR gene have been identified, and some have been associated with cardiovascular disease (CVD) risk factors. This study aims to evaluate the association of five SNPs in the VDR gene with 25-hydroxyvitamin D (25[OH]D) levels in patients with at least one CVD risk factor.

Material And Methods: Genomic DNA was sequenced using standard Sanger methods for five VDR SNPs (I rs1544410; I rs7975232; 2 rs11568820; I rs731236; I rs2228570) in 50 Mediterranean subjects having hypovitaminosis D with at least one documented CVD risk factor, aged 18 years or more. The collected variables were serum levels of (25[OH]D), HbA, fasting plasma glucose, triglycerides, LDL cholesterol, and total cholesterol.

Results: I, I, and I were moderately to highly intercorrelated. 2 was less frequent than expected. With respect to the number of mutations in I, levels of (25 [OH]D) were 11.2 ±5.5 ng/ml in the absence of mutations, 12.6 ±4.7 ng/ml in the presence of one mutation, and 16.5 ± 5.5 ng/ml in the presence of two mutations.

Conclusions: I polymorphism is more frequent in subjects with cardiovascular risk factors than in the general Caucasian population.
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http://dx.doi.org/10.5114/amsad.2019.91437DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7191939PMC
December 2019

Duchenne Smile is Associated with Quality of Life and Survival in Hemodialysis Patients.

Am J Health Behav 2020 05;44(3):313-325

Dania Chelala, Head, Nephrology Department, School of Medicine, Saint-Joseph University of Beirut, Hôtel-Dieu de France Hospital, Lebanon.

Hemodialysis is the most used renal replacement modality for end-stage renal disease patients. Dialysis patients are usually assessed for quality of life (QoL) but smiling was never studied. Duchenne smile is a genuine expression of joy, associated with better survival in some groups of the general population. In this study, we aimed to evaluate whether the smile of dialysis patients can predict their QoL and mortality. All hemodialysis patients in Saint-George Hospital were included in this prospective study. Patients were interviewed using the Health-Related QoL questionnaire and followed for 10 days for smile screening. Those who smiled more than 34% of time were considered as smiling, then followed for death over 2 years. Overall, 71 patients were studied. Duchenne smile was associated with death at 1 and 2 years (HR = 0.194 [95% CI 0.039-0.958], p = .044) but not with sex or diabetes. Smiling showed a statistically significant correlation with older age, fewer hospitalizations, vitality, physical component score, several QoL scores and general health. A simple observation of patients' Duchenne smile by nephrologists in hemodialysis units can give an idea about their QoL and 2-year survival.
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http://dx.doi.org/10.5993/AJHB.44.3.4DOI Listing
May 2020

Comparison between Second- and Third-Generation PTH Assays during Minimally Invasive Parathyroidectomy (MIP).

Int J Endocrinol 2020 16;2020:5230985. Epub 2020 Mar 16.

Department of Biostatistics, Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon.

Methods: 112 patients (of which 72.3% females) underwent MIP by the same surgeon. Age, sex, body mass index (BMI), pre- and postoperative serum calcium, creatinine, 25(OH)D levels, PTH at baseline (PTH T0), and PTH at 10 minutes after adenoma resection (PTH T10) were recorded. Both PTH 2G and PTH 3G assays were assessed using the Diasorin assays.

Results: The mean age was 56.1 ± 14.7 years. Mean value of BMI, preoperative calcium, 25(OH)D, and CKD-EPI-eGFR were, respectively, 26.8 ± 4.8 kg/m, 110.9 ± 7.9 mg/L, 19.3 ± 9.2 ng/mL, and 88.6 ± 25.6 mL/min/1.73 m. PTH 2G and PTH 3G assays were well correlated at PTH T0 and PTH T10 (respectively, correlation coefficient 0.74 and 0.72 for intraclass correlation type 3). The median PTH fall was, respectively, of 79.9% and 82.5% for PTH 2G and PTH 3G. Multivariate analysis using the combined PTH 2G and PTH 3G as a dependent variable with 2 repeated measurements (at PTH 0 and PTH 10) showed a significant effect of preoperative calcium on IOPTH fall (=0.001, effect size 0.13), while no significant effects were observed for sex, age, BMI, and 25(OH)D.

Conclusion: PTH 2G and PTH 3G assays resulted in a similar drop in IOPTH values. Elevated preoperative calcium levels are the only independent predictor of IOPTH decline. Further studies are needed to determine other factors that can influence PTH kinetics.
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http://dx.doi.org/10.1155/2020/5230985DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7102406PMC
March 2020

Parathormone Levels in a Middle-Eastern Healthy Population Using 2 and 3 Generation PTH Assays.

Int J Endocrinol 2020 21;2020:6302861. Epub 2020 Feb 21.

Department of Biostatistics, Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon.

Background: The purpose of the current study is to determine PTH reference values in vitamin-D-replete Lebanese adults using 2 and 3 generation PTH assays and to look at the factors that affect PTH variations.

Methods: Fasting PTH was measured using 2 and 3 generation Diasorin PTH assays in 339 vitamin-D-replete healthy subjects aged 18 to 63 years (230 men and 109 women) who have normal calcium levels and an eGFR ≥60 ml/mn. 25-OH vitamin D (25(OH)D) was measured using the Diasorin assay.

Results: For the 2 PTH generation, median (IQR) levels were 48.9 (34.9-66.0) pg/ml, and its 2.5-97.5 percentile values were 19.7-110.5 pg/ml for 25(OH)D values between 20 and 30 ng/ml, and 19.7-110.7 pg/ml for 25(OH)D values ≥30 ng/ml. For the 3 PTH generation, the median (IQR) values were 23.9 (17.7-30.5) pg/ml, and its 2.5-97.5 percentile values were, respectively, 9.2 and 50.2 pg/ml for 25(OH)D values between 20 and 30 ng/ml, and 8.4 and 45.4 pg/ml for 25(OH)D values ≥30 ng/ml. The median (IQR) serum 25(OH)D levels were 27.5 (23.8-32.7) ng/ml. 2 and 3 generation PTH values are strongly correlated ( = 0.96, < 0.0001), but poorly concordant (Lin's concordance coefficient 0.365, 95% CI: 0.328-0.401) with observations beyond the 95% Bland-Altman limits of agreement. 2 and 3 generation PTH levels did not differ according to gender and were significantly correlated with age but not with 25(OH)D and serum calcium levels.

Conclusion: Lebanese adult healthy subjects have higher 2 and 3 generation PTH levels compared with the reference range provided by the manufacturer. The reference range was not influenced by changing the 25(OH)D cutoff. The clinical significance of the higher PTH levels in our population should be investigated.
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http://dx.doi.org/10.1155/2020/6302861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7054794PMC
February 2020

Prevalence of Iron deficiency in Lebanese schoolchildren.

Eur J Clin Nutr 2020 08 3;74(8):1157-1163. Epub 2020 Mar 3.

Department of Endocrinology, Faculty of Medicine, Saint-Joseph University, Beirut, Lebanon.

Background: The prevalence of iron deficiency in the Lebanese pediatric population is unknown. The aim of this study is to estimate this prevalence in Lebanese schoolchildren and to assess the relation between iron status and related factors.

Subjects/methods: A total of 903 children aged 8-18 years (466 boys and 437 girls) were included in the study. Recruitment was done from ten schools with different SES levels and located in the Great Beirut and Mount Lebanon areas. Serum ferritin was measured in all participants and testosterone was measured only in boys using Immulite chemiluminescent assays.

Results: For the entire sample, the median serum ferritin concentration was 30.0 [19.8-44.8] ng/mL and the prevalence of iron deficiency (ferritin < 15 ng/mL) was 14.2%. Iron deficiency was higher in girls compared with boys (respectively, 20.8% and 7.9%). This prevalence varied with the SES (respectively, 11.6%, 11.9%, and 16.8% in high, middle, and low SES, p = 0.09). Iron deficiency increased with age (9.5%, 15.7%, and 17.5%, respectively, for the age groups 8-11, 12-14, and 15-18, p = 0.014) and did not differ between normal, overweight, and obese groups (p = 0.07). In boys, a significant positive correlation was observed between ferritin and total testosterone (rho = 0.150, p = 0.001).

Conclusion: The prevalence of iron deficiency is relatively low in Lebanon. Younger boys, menstruating girls, and children from low SES are more prone to iron deficiency, while BMI has no impact.
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http://dx.doi.org/10.1038/s41430-020-0590-yDOI Listing
August 2020

Classification and Regression Tree (CART) model of sonographic signs in predicting thyroid nodules malignancy.

Eur J Radiol Open 2019 28;6:343-349. Epub 2019 Nov 28.

Endocrinology Department, School of Medicine, Hotel-Dieu Hospital, Saint Joseph University, Alfred Naccache Street, PO Box: 16-6830, Beirut, Lebanon.

Purpose: To develop a Classification and Regression Tree (CART) model in order to recognize the most suspicious sonographic features of thyroid nodules and efficiently guide their management.

Methods: 791 thyroid fine needle aspiration cytology (FNAC) performed under ultrasound guidance between January 2015 and January 2017 were reviewed. Retrieved data consisted in qualitative (patient's gender, composition, echogenicity, shape, margins and echogenic foci of the nodule) and quantitative (patient's age and maximal diameter of the nodule) variables as well as the Bethesda score.

Results: Patients were 48.5 ± 13.7 years old with female to male ratio of 8:2. The nodules had median size of 2.3 (1.5-3.5) cm with a majority of solid (62.5 %) and isoechoic (50.8 %) features. 700 nodules (88.5 %) had a wider-than-tall shape, 600 (75.9 %) smooth margins and 113 (14.3 %) ill-defined ones. Echogenic foci were absent in 388 nodules (49.1 %) and, when present, largely dominated by punctate foci (32.5 %). Bethesda classes 3, 4 and 5, which require surgery, represented only 10.6 % of cases. They were significantly correlated with the taller-than-wide shape and with solid or predominantly solid features. There was no significant correlation between echostructure and Bethesda scores but we did find more nodules classified Bethesda 4 and 5 in the categories hypoechoic and severely hypoechoic. In the CART model we developed, the sequence leading to most nodules classified Bethesda 4 and 5 is: taller-than-wide shape, solid composition and hypoechoic or severely hypoechoic feature.

Conclusions: Taller-than-wide, solid or predominantly solid, hypoechoic or severely hypoechoic nodules are likely to require surgery and might benefit from FNAC.
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http://dx.doi.org/10.1016/j.ejro.2019.11.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6909041PMC
November 2019

How do Lebanese patients perceive the ideal doctor based on the CanMEDS competency framework?

BMC Med Educ 2019 Oct 29;19(1):399. Epub 2019 Oct 29.

School of Medicine, Saint-Joseph University, Beirut, Lebanon.

Background: During their training, Lebanese medical students develop a high medical expertise but are not focusing on other competencies such as communication, collaboration, erudition, professionalism, leadership and health promotion. There is also insufficient data about patients' preference for these skills. This study describes the different weights patients attribute to these physician's competencies.

Methods: This is a cross-sectional study based on a questionnaire distributed to 133 Lebanese patients. It included 15 questions assessing how patients prioritize the physician's competencies, with open-ended questions asking them to define "the good doctor". Krippendorff's alpha coefficient was used to analyze the reliability of the competencies' classification.

Results: One hundred twenty five patients completed the questionnaire in this cross-sectional study. Their mean age was 48 ± 16.76 years. When classifying competencies, 73.6% opted for medical expertise as first choice and 48% put communication as second. Based on the Krippendorff's coefficient, we identified a moderate agreement for the seven choices (alpha = 0.44). In open-ended questions, patients defined the good doctor in 325 answers: 64.3% mentioned medical expertise, 34.1% high ethics and 26.2% communication.

Conclusions: This patient-centered study concurs well with the worldwide practice that puts medical expertise at the center of medical education. However Lebanese patients don't perceive equally other competencies and favor professionalism and communication that should be integrated in priority in students' curricula.
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http://dx.doi.org/10.1186/s12909-019-1837-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6821035PMC
October 2019

Correlation between Temporomandibular Joints and Nasal Cavity Width in Growing Patients after Rapid Maxillary Expansion.

J Contemp Dent Pract 2019 Jun 1;20(6):686-692. Epub 2019 Jun 1.

Department of Prosthodontics, School of Dental Medicine, Hadath, Lebanon.

Aim: The study tests the correlation between the enlargement of the nasal cavity width, interglenoid fossa distance, and intercondylar distance after rapid maxillary expansion (RME) in growing patients.

Materials And Methods: Cone beam computed tomography (CBCT) was performed for 25 patients presenting a bilateral crossbite (11 males, 14 females, and mean age 11.6 ± 1.6 years) at baseline (T0) and at 6 months after RME (T2), T1 being the end of expander activation. Images were digitized for linear measurements using specific software. Values were compared at the nasal width, interglenoid fossa distance, and intercondylar distance to test the correlation in the transverse dimension.

Results: At T0, a correlation already existing between the interglenoid fossa distance and the intercondylar distance persisted at T2. The correlation between the nasal cavity width and interglenoid fossa distance nonexistent at T0 ended toward statistically significant at T2. Additionally, the lateral position of the condyles was not correlated with the nasal cavity width neither at T0 or T2.

Conclusion: A correlation between the interglenoid fossa distance and intercondylar distance was exhibited 6 months after RME. The correlation between the nasal cavity width and interglenoid fossa distance was close to significant at T2.
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June 2019

The impact of haemophilia on the social status and the health-related quality of life in adult Lebanese persons with haemophilia.

Haemophilia 2019 Mar 12;25(2):264-269. Epub 2019 Feb 12.

Hotel Dieu de France Hospital, Saint Joseph University, Beirut, Lebanon.

Introduction: Health-related quality of life (HRQoL) studies are increasingly needed to prevent and improve the medical care of persons with haemophilia (PWH).

Aim: We assessed the impact of haemophilia on HRQoL and social status of adult Lebanese PWH compared to a reference population.

Methods: In this case-control study, 60 severe and moderate PWH were compared to 112 healthy controls. Detailed socio-demographic data and disease characteristics were collected, and HRQoL was assessed using the SF-36 questionnaire.

Results: Age, body mass index and the percentage of married people were similar in PWH and controls. A greater proportion of controls attained a higher educational level than cases (88.4% vs 59.3%, respectively, P < 0.001). PWH were more likely to have a job requiring physical activity than controls (55.9% vs 31.4%) and more likely to be unemployed (10.2% vs 1.0%), whereas more controls had higher socio-economic jobs (10.5% vs 1.7%). PWH had significantly (P < 0.001) worse scores in all SF-36 domains except for energy/fatigue. Affected targeted joints (2.7 ± 1.5) and monthly bleeding frequency (2.9 ± 2.4) were inversely correlated with almost all SF-36 domains. Only 26.7% of PWH walk normally, and walking abnormalities were inversely correlated with all SF-36 domains except role-emotional and emotional well-being.

Conclusion: As compared with controls, the majority of Lebanese PWH has difficulties in social integration, has severe physical limitations and psychological impairments.
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http://dx.doi.org/10.1111/hae.13694DOI Listing
March 2019

Longitudinal changes of lipid profile in the Lebanese pediatric population.

Lipids Health Dis 2019 Feb 11;18(1):48. Epub 2019 Feb 11.

Endocrinology Department, Faculty of Medicine, Saint Joseph University, Saint-Joseph, Beirut, Lebanon.

Background: Few studies looked at the prevalence of dyslipidemia in pediatric Middle-Eastern countries. In addition, worldwide longitudinal changes of lipid profile is not well documented. The purpose of this study is to look at the longitudinal changes of lipid parameters in Lebanese school-age children.

Materials And Methods: A total of 97 subjects (41 girls and 56 boys) aged between 11 and 21 years were included in this study. The subjects were selected among 339 school-age children with a previous abnormal lipid profile who were recruited from 10 schools of varying socio-economic levels (SEL). A fasting lipid profile [total cholesterol (TC), triglycerides (TG) and HDL-cholesterol (HDL-C)] was performed. Non-HDL-cholesterol (Non-HDL-C) was calculated. Weight and height were measured under the same conditions, and BMI percentiles were calculated. A multivariate covariance analysis model (MANCOVA) was used with TG, HDL-C and non-HDL-C as dependent variables with additional post-MANCOVA F tests.

Results: The age of the current cohort is 16.5 ± 2.9 years with no significant difference according to gender. The current lipid profile was obtained 3.1 ± 0.7 years following the initial one, with 53.6% of the subjects having it normalized. TC, TG, and non-HDL-C decreased significantly over time in girls, while only TG decreased significantly in boys. No significant changes were observed for HDL-C. Using MANCOVA, a significant time by age interaction was observed (p < 0.0001), while gender, BMI and SEL were found not to be significant. Post-hoc F tests showed that the time by age interaction was driven by TG (p = 0.03) and non-HDL-C (p < 0.001), the larger effect being observed in younger children.

Conclusion: A high proportion of school-age children normalize their abnormal lipid profile with time. Screening for lipid disorders could be postponed until post puberty age.
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http://dx.doi.org/10.1186/s12944-019-0991-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371449PMC
February 2019

Effect of Rapid Maxillary Expansion on Condyle-fossa Relationship in Growing Patients.

J Contemp Dent Pract 2018 Oct 1;19(10):1189-1198. Epub 2018 Oct 1.

Department of Prosthodontics, School of Dental Medicine, Hadath, Lebanon.

Aim: This study tests whether rapid maxillary expansion (RME) exerts long term effects on interglenoid fossa distance and condyle fossa relationship.

Materials And Methods: Consecutive growing patients aged 8 to 13 years were allocated either to the RME group or control group. Cone-beam computed tomography was performed at baseline and at 6 months. Specific software was used to determine fixed landmarks. Multivariate Analysis of Covariance (MANCOVA) models were used, with time by group interaction, using age as a covariate.

Results: Twenty-seven patients with a mean age of 11.4 ± 1.5 years were included. There was an overall significant group by time interaction (p = 0.012, effect size 0.59). Change in the lateral position of the glenoid fossa, the primary outcome, was reached (p = 0.008, effect size 0.258). Change in the laterolateral position of the center of the condyle, and the co-primary outcome was also significant (p = 0.011, effect size = 0.24). Nasal cavity width increased (p = 0.065, effect size = 0.14). There was an initial asymmetry in the horizontal position of the condyles that was carried on with no effect of RME.

Conclusion: Rapid maxillary expansion (RME) produces a significant increase in the interglenoid fossa distance and displacement of the mandibular condyles at 6 months in growing patients compared to a control group.

Clinical Significance: The current study shows that RME is effective during growth, widening the interglenoid fossa distance and the lateral positions of the condyles and eventually enlarging the nasal cavity, without causing asymmetry.
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October 2018

Safety and Efficacy of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Used for Analgesia After Bariatric Surgery: A Retrospective Case-Control Study.

Obes Surg 2019 03;29(3):911-916

Department of Anesthesia, Crtitical Care and Pain Management, Hôtel Dieu de France hospital, Saint Joseph university school of medicine, P.O.Box 11-5076, Beirut, 1107 2180, Lebanon.

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are cornerstone in multimodal analgesia protocols. This point is of great value in morbidly obese patients due to the high prevalence of restrictive pulmonary disease and obstructive sleep apnea. The aim of this study was to test the hypothesis that NSAIDs do not increase acute bariatric surgery complications while optimizing postoperative analgesia.

Methods: Databases of two medical centers were retrospectively reviewed to find all patients who underwent bariatric surgery between 1 January 2017 and 31 December 2017. Inclusion criteria were BMI greater than 30 kg/m and age of 16-75 years old. Patients who suffered from severe organ failure or coagulation disorders were excluded. Patient's demographics, obesity-related diseases (diabetes, hypertension, dyslipidemia), postoperative pain scores, and morphine consumption in PACU, as well as early and late surgical complications, were collected. Patients included from the first institution (where NSAIDs analgesia was prohibited: control group) were compared to patients from the second institution (where NSAIDs analgesia was mandatory: case group).

Results: The study population included 270 patients, 134 in the control group, and 136 in the case group. NSAIDs usage produced better analgesia with significant reduction in morphine consumption and PACU length of stay. Also, incidence of surgical complications was the same in the two groups.

Conclusions: NSAIDs administration do not increase postoperative complication rate after bariatric surgery. Although NSAID administration provided better analgesia and shorter PACU stay, future prospective studies are needed to confirm these encouraging results and to evaluate their impact on postoperative rehabilitation.
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http://dx.doi.org/10.1007/s11695-018-3608-yDOI Listing
March 2019

Association between vitamin D deficiency and lipid and non-lipid markers of cardiovascular diseases in the middle east region.

Eur J Clin Nutr 2019 06 10;73(6):850-858. Epub 2018 Aug 10.

Laboratoire de recherche en Physiologie et Physiopathologie (LRPP), pôle technologie santé, Faculté de Médecine, Université Saint Joseph, Beirut, Lebanon.

Background: Previous studies have associated vitamin D deficiency with cardiovascular disease (CVD) markers. The underlying mechanism remains elusive. Lipid and non-lipid markers of CVD and their relationship to vitamin D deficiency have not been assessed simultaneously.

Objective: To measure the association between vitamin D deficiency and non-lipid markers of CVD after adjustment of lipid markers.

Methods: This cross-sectional study used the following biological data, which was routinely collected in a general hospital laboratory database between 2011 and 2016: 25OH vitamin D [25(OH)D], creatinine, CKD-EPI eGFR (eGFR), fasting blood glucose (FPG), glycated hemoglobin (HbA1c), uric acid, γ-glutamyl transferase (γGT), C-reactive protein (CRP), total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, and a surrogate for CVD. Crude odds ratios (ORs) and ORs adjusted for lipid profile, gender and age using separate logistic regression models were derived.

Results: A total of 8658 subjects were included. Half had 25(OH)D < 20 ng/mL. 25(OH)D was associated with increased odds of CRP, eGFR, increased uric acid, γGT, FPG, HbA1c, male gender, CV status, and abnormal lipid markers. After adjustment for lipid markers, age, and gender, vitamin D deficiency was associated with increased odds of CRP, eGFR, γGT, FPG, HbA1c, and the surrogate for CVD.

Conclusions: In this exploratory analysis, the first of its kind in the MENA region, vitamin D deficiency was associated with abnormal lipid markers, non-lipid markers of CVD, male gender, lower eGFR, and a surrogate variable for CVD. The association between vitamin D deficiency and non-lipid markers of CVD persisted after adjustment for lipid markers, age, and gender.
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http://dx.doi.org/10.1038/s41430-018-0280-1DOI Listing
June 2019

Effect of Rapid Maxillary Expansion on Glenoid Fossa and Condyle-Fossa Relationship in Growing Patients (MEGP): Study Protocol for a Controlled Clinical Trial.

J Int Soc Prev Community Dent 2018 Mar-Apr;8(2):130-136. Epub 2018 Apr 24.

Department of Biostatistics and Epidemiology, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.

Aims And Objectives: Rapid maxillary expansion (RME) is an orthodontic nonsurgical procedure aiming at increasing the width of the maxilla by opening mainly the intermaxillary suture in patients presenting a transverse maxillary skeletal deficiency. The objectives of the current prospective controlled clinical and radiographic study are to evaluate the hypothesis that RME in growing patients will result in radiographic changes at the level of interglenoid fossa distance, condyle-fossa relationship, and nasal cavity widths compared to the group who received no treatment initially and served as untreated control.

Materials And Methods: In this prospective controlled clinical and radiographic study, forty healthy growing patients selected from a school-based population following a large screening campaign, ranging in age between 8 and 13 years, presenting a maxillary constriction with bilateral crossbite, and candidates for RME are being recruited. The first group will include participants willing to undergo treatment ( = 25) and the other group will include those inclined to postpone ( = 15).

Results: The primary outcome is to compare radiologically the interglenoid fossa distance and the condyle-fossa relationship; nasal cavity width will be a secondary outcome. A multivariable analysis of Covariance model will be used, with the assessment of the time by group interaction, using age as covariate. The project protocol was reviewed and approved by the Ethics Committee of the Lebanese University, National Institute in Lebanon (CUEMB process number 31/04/2015). The study is funded by the Lebanese University and Centre National de Recherche Scientifique, Lebanon (Number: 652 on 14/04/2016).

Conclusion: This prospective controlled clinical trial will give information about the effect of RME on the glenoid fossa and condyle-fossa relationship and its impact on the nasal cavity width.

Trial Registration: Retrospectively registered in BioMed Central (DOI10.1186/ISRCTN77788053).
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http://dx.doi.org/10.4103/jispcd.JISPCD_458_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5946521PMC
April 2018

A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer.

Immunotherapy 2018 06 22;10(8):657-663. Epub 2018 Mar 22.

Department of Medical Oncology, Hotel Dieu de France University Hospital, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.

Aim: To determine which of the approved immune checkpoint inhibitors is the optimal treatment in metastatic urothelial bladder cancer.

Methods & Materials: Only the pivotal Phase III trials of second-line metastatic urothelial bladder cancer were included in this network meta-analysis.

Results: This NMA included three pooled trials (NCT00315237, NCT02256436 and NCT02302807) of 1125 participants. Pembrolizumab was the only treatment with positive effect on overall survival compared with the best supportive care. The treatment discontinuation rates due to adverse events of the pembrolizumab and atezolizumab did not differ from that of the best supportive care. C onclusion: Our results confirmed the superiority of pembrolizumab in the management of metastatic urothelial bladder cancer.
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http://dx.doi.org/10.2217/imt-2017-0190DOI Listing
June 2018

Iron deficiency across chronic kidney disease stages: Is there a reverse gender pattern?

PLoS One 2018 22;13(1):e0191541. Epub 2018 Jan 22.

Ministry of Public Health, Beirut, Lebanon.

In non-dialysis chronic kidney disease patients, looking for iron deficiency is highly variable in practice and there is a great variability regarding the cutoffs used to treat iron deficiency. The aim of this study is to investigate the degree of iron deficiency in non-dialysis chronic kidney disease patients on erythropoiesis-stimulating agents. We included all non-dialysis chronic kidney disease patients that applied to the Lebanese Ministry of Public Health for erythropoiesis-stimulating agents' coverage during a 5-month period. Iron requirement was assessed based on two guidelines' target-to-treat cutoffs: 1-ferritin <100 ng/ml and/or TSAT < 20% (KDOQI 2006), 2- ferritin ≤500 ng/ml and TSAT ≤30% (KDIGO 2012). A total of 238 CKD patients were included over 5 months. All patients had a ferritin level in their record and 64% had an available TSAT. Median age was 71.0 (59.8-79.3) years and 61.8% were female. All had an eGFR<60 ml/min. The proportion of patients found to require iron therapy ranged between 48 and 78% with a trend towards higher values when using KDIGO-based criteria. Using ANCOVA test, inverse normal transformations of ferritin and TSAT showed a reverse pattern between men and women with women being more iron deficient in the early stage. Iron deficiency is highly prevalent in non-dialysis chronic kidney disease patients on erythropoiesis-stimulating agents' therapy. These findings reflect a lack in effective iron supplementation when managing anemia in pre-dialysis patients, especially in men at advanced stages. Renal societies should spread awareness about iron deficiency screening in those patients.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191541PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5777643PMC
March 2018

The optimal treatment of metastatic hormone-naive prostate cancer: abiraterone acetate or docetaxel?

Future Oncol 2017 Dec 30;13(30):2785-2790. Epub 2017 Nov 30.

Department of Medical Oncology, Hotel Dieu de France University Hospital, Faculty of Medicine, Saint Joseph University, Beirut, Lebanon.

Aim: To determine whether abiraterone acetate or docetaxel should be regarded as the current standard of care for metastatic hormone-naive prostate cancer (mHNPC).

Methods & Materials: A network meta-analysis (NMA) using the frequentist approach and generalized pairwise modeling was computed.

Results: The results of this NMA favored abiraterone acetate over docetaxel-based regimens (hazard ratio: 0.79; 95% CI: 0.64-0.99) in patients with mHNPC. The results also suggest a reconsideration of the role of prednisone in view of the absence of a survival benefit (hazard ratio: 0.98; 95% CI: 0.59-1.65) with its use.

Conclusion: Despite the paucity of direct comparative evidence, the results of this NMA favor the use of abiraterone acetate in the first-line treatment of mHNPC.
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http://dx.doi.org/10.2217/fon-2017-0445DOI Listing
December 2017

Network meta-analysis of second-line treatment in metastatic renal cell carcinoma: efficacy and safety.

Future Oncol 2017 Dec 29;13(29):2709-2717. Epub 2017 Nov 29.

Department of Urology, Université Libre de Bruxelles, Erasme Hospital, Brussels, Belgium.

This paper aims to compare the approved second-line treatment options in metastatic renal cell carcinoma. A network meta-analysis (NMA) using the frequentist approach and generalized pairwise modeling was computed for the approved drugs in this setting. The results of this NMA showed that the combination of lenvatinib and everolimus yielded the lowest hazard ratio (HR) for progression-free survival (HR: 0.4; 95% CI: 0.21-0.75) and overall survival (HR: 0.55; 95% CI: 0.30-1.00). The great efficacy of this combination is limited by the prevalence of grade 3-4 adverse events (70.6%) leading to treatment discontinuation in 17.6%. This NMA is to the best of our knowledge, the first analysis of the approved regimens for the second-line treatment of metastatic renal cell carcinoma.
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http://dx.doi.org/10.2217/fon-2017-0268DOI Listing
December 2017

A cost-effectiveness analysis of first-line induction and maintenance treatment sequences in patients with advanced nonsquamous non-small-cell lung cancer in France.

Clinicoecon Outcomes Res 2017 16;9:505-518. Epub 2017 Aug 16.

Thoracic Oncology, Service de Pneumologie, Centre Hospitalier Intercommunal Créteil, Créteil, France.

Background: Comparative effectiveness and cost-effectiveness data for induction-maintenance (I-M) sequences for the treatment of patients with nonsquamous non-small-cell lung cancer (nsqNSCLC) are limited because of a lack of direct evidence. This analysis aimed to compare the cost-effectiveness of I-M pemetrexed with those of other I-M regimens used for the treatment of patients with advanced nsqNSCLC in the French health-care setting.

Materials And Methods: A previously developed global partitioned survival model was adapted to the France-only setting by restricting treatment sequences to include 12 I-M regimens most relevant to France, and incorporating French costs and resource-use data. Following a systematic literature review, network meta-analyses were performed to obtain hazard ratios for progression-free survival (PFS) and overall survival (OS) relative to gemcitabine + cisplatin (induction sequences) or best supportive care (BSC) (maintenance sequences). Modeled health-care benefits were expressed as life-years (LYs) and quality-adjusted LYs (QALYs) (estimated using French EuroQol five-dimension questionnaire tariffs). The study was conducted from the payer perspective (National Health Insurance). Cost- and benefit-model inputs were discounted at an annual rate of 4%.

Results: Base-case results showed pemetrexed + cisplatin induction followed by (→) pemetrexed maintenance had the longest mean OS and PFS and highest LYs and QALYs. Costs ranged from €12,762 for paclitaxel + carboplatin → BSC to €35,617 for pemetrexed + cisplatin → pemetrexed (2015 values). Gemcitabine + cisplatin → BSC, pemetrexed + cisplatin → BSC, and pemetrexed + cisplatin → pemetrexed were associated with fully incremental cost-effectiveness ratios (ICERs) of €16,593, €80,656, and €102,179, respectively, per QALY gained versus paclitaxel + carboplatin → BSC. All other treatment sequences were either dominated (ie, another sequence had lower costs and better/equivalent outcomes) or extendedly dominated (ie, the comparator had a higher ICER than a more effective comparator) in the model. Sensitivity analyses showed the model to be relatively insensitive to plausible changes in the main assumptions, with none increasing or decreasing the ICER by more than ~€20,000 per QALY gained.

Conclusion: In the absence of direct comparative trial evidence, this cost-effectiveness analysis indicated that of a large number of I-M sequences used for the treatment of patients with nsqNSCLC in France, pemetrexed + cisplatin → pemetrexed achieved the best clinical outcomes (0.28 incremental QALYs gained) versus paclitaxel + carboplatin → BSC.
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http://dx.doi.org/10.2147/CEOR.S128371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5566359PMC
August 2017