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Nevin Manimala Statistics

Gluten-free wafer formulation: Development, characterisation and addition of flavourings with antioxidant capacity

Food Sci Technol Int. 2022 Nov 4:10820132221135275. doi: 10.1177/10820132221135275. Online ahead of print.

ABSTRACT

The incidence of celiac disease is increasing, therefore the demand for gluten-free products that also satisfy the nutritional requirements of celiac individuals is rising. Thus, the objective of the present work was to develop a gluten-free nutritionally balanced wafer formulation with a high content of antioxidants. First, the animal fat used in the traditional formulation was successfully replaced by high oleic sunflower. Second, the antioxidant content of several flavourings (cinnamon/honey/anise/vanilla) was measured and their addition to a gluten-free wafer formulation was evaluated. Third, multivariate statistical tools were used to select the formulation that properly mimicked the characteristics of a gluten-containing wafer. According to the results, anise and cinnamon were the most suitable flavourings to prepare gluten-free wafers, and the sensory analysis concluded that these formulations were highly acceptable (means>6.7 on the hedonic scale). Finally, the storage time analysis indicated that the texture of the gluten-free wafers was more susceptible to water absorption than gluten-containing wafers. Besides, cinnamon wafers presented a higher bioaccessible antioxidant capacity than anise wafers (43.5 ± 0.1 mg Trolox/g and 18.8 ± 0.9 mg Trolox/g respectively) (p < 0.05), which remained stable for four months. This indicates that during its shelf life, the product could be consumed with its beneficial effects intact.

PMID:36330715 | DOI:10.1177/10820132221135275

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Nevin Manimala Statistics

Model-based population pharmacokinetic analysis of tislelizumab in patients with advanced tumors

CPT Pharmacometrics Syst Pharmacol. 2022 Nov 4. doi: 10.1002/psp4.12880. Online ahead of print.

ABSTRACT

Tislelizumab, a humanized immunoglobulin G4 monoclonal antibody, is a programmed cell death protein 1 (PD-1) inhibitor designed to minimize Fc gamma receptor binding on macrophages to limit antibody-dependent phagocytosis, a potential mechanism of resistance to anti-PD-1 therapy. The pharmacokinetic (PK) profile of tislelizumab was analyzed with population PK modeling using 14,473 observed serum concentration data points from 2596 cancer patients who received intravenous (IV) tislelizumab at 0.5-10 mg/kg every 2 weeks or every 3 weeks (Q3W), or a 200 mg IV flat dose Q3W in 12 clinical studies. Tislelizumab exhibited linear PK across the dose range tested. Baseline body weight, albumin, tumor size, tumor type, and presence of anti-drug antibodies were identified as significant covariates on central clearance, while baseline body weight, sex, and age significantly affected central volume of distribution. Sensitivity analysis showed that these covariates did not have clinically relevant effects on tislelizumab PK. Other covariates evaluated, including race (Asian vs. White), lactate dehydrogenase, estimated glomerular filtration rate, renal function categories, hepatic function measures and categories, Eastern Cooperative Oncology Group performance status, therapy (monotherapy vs. combination therapy), and line of therapy did not show a statistically significant impact on tislelizumab PK. These results support the use of tislelizumab 200 mg IV Q3W without dose adjustment in a variety of patient subpopulations.

PMID:36330700 | DOI:10.1002/psp4.12880

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Comparing the effects of ankle integral and conventional physiotherapy on pain, range of motion, balance, disability, and treatment effectiveness in patients with chronic ankle instability: Randomized controlled trial

Clin Rehabil. 2022 Nov 4:2692155221134993. doi: 10.1177/02692155221134993. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the effects of ankle integral and conventional physiotherapy on pain, range of motion, balance, disability, and treatment effectiveness in patients with chronic ankle instability (CAI).

DESIGN: Two-arm, parallel-group, randomized, double-blind, controlled trial.

PARTICIPANTS: 60 patients with unilateral CAI.

INTERVENTION: integral physiotherapy (n = 30) or conventional physiotherapy (n = 30).

OUTCOMES: Visual Analog Scale (VAS), dorsiflexion and plantarflexion range of motion, Star Excursion Balance Test (SEBT), Single Leg Hop (SLH) test, Foot and Ankle Outcome Score (FAOS), Lower Extremity Functional Score (LEFS), global rating of change, were gathered pre and post-intervention.

RESULTS: The ANOVA results revealed statistically significant interaction for FAOS, and LEFS outcome measures (P < 0.05) and the mean change results showed there were a favorable clinical difference incline toward the integral group (meanintegral = 20.14 (14.95-25.37), meanConventional = 29.46 (24.09-34.83)). There were no interactions between group and time among other outcome measures (P > 0.05). The group main effect did not show any statistical significance (P > 0.05).

CONCLUSION: Hip strengthening and balance exercises added to ankle rehabilitation could be more favorable on improving the patients’ functional ability.

PMID:36330694 | DOI:10.1177/02692155221134993

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Nevin Manimala Statistics

Soft tissue dimensional change following guided bone regeneration on peri-implant defects using soft-type block or particulate bone substitutes: 1-year outcomes of a randomized controlled clinical trial

J Clin Periodontol. 2022 Nov 4. doi: 10.1111/jcpe.13738. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare the peri-implant soft-tissue dimensional changes following guided bone regeneration between particulate (particle group) and collagenated soft-block-type (block group) biphasic calcium phosphate (BCP).

MATERIALS AND METHODS: This study investigated 35 subjects: 18 particle-group and 17 block-group patients. Cone-beam computed tomography obtained at 6 months post-surgery and optical impressions taken periodically (presurgery, 6 months post-surgery and 1 year post-surgery) were superimposed. The ridge contour changes over time and the peri-implant mucosal thicknesses were measured diagonally and horizontally, and analysed statistically.

RESULTS: The increases in diagonal (1.12±0.78 mm) and horizontal (2.79±1.90 mm) ridge contour of the block group were significantly higher than the particle group during the first 6 months (p < 0.05), however, the contour hardly changed thereafter (diagonal: 0.07±0.75 mm; horizontal: -0.34±1.26 mm), resulting in the 1-year contour changes similar between the two groups. Regardless of the type of BCP, the ridge contour increased significantly over 1 year when the dehiscence defect had a contained configuration (p < 0.05).

CONCLUSION: The soft-tissue dimensional increases for 1 year were similar between the two groups. The mucosal contour increase was larger when the surgery was conducted in a more-contained defect, and this was not influenced by the type of BCP. This article is protected by copyright. All rights reserved.

PMID:36330670 | DOI:10.1111/jcpe.13738

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Nevin Manimala Statistics

Pitfalls in the statistical analysis of microbiome amplicon sequencing data

Mol Ecol Resour. 2022 Nov 4. doi: 10.1111/1755-0998.13730. Online ahead of print.

ABSTRACT

Microbiome data are characterized by several aspects that make them challenging to analyse statistically: they are compositional, high dimensional, and rich in zeros. There is a large array of statistical methods used to analyse these data. Some are borrowed from other fields, as from ecology or RNA-Sequencing, while others are custom-made for microbiome data. The large range of available methods, which moreover is continuously expanding, means that researchers have to invest a considerable effort in choosing what method(s) to apply. In this paper we list 14 statistical methods or approaches that we think should be generally avoided. In several cases this is because we believe the assumptions behind the method are unlikely to be met for microbiome data. In other cases we see methods that are used in ways they are not intended to be used. We believe researchers would be helped by more critical evaluations of existing methods, as not all methods in use are suitable or have been sufficiently reviewed. We hope this paper contributes to such a critical discussion on what methods are appropriate to use in the analysis of microbiome data.

PMID:36330663 | DOI:10.1111/1755-0998.13730

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Nevin Manimala Statistics

Impact of moral injury and posttraumatic stress disorder on health care utilization and suicidality in rural and urban veterans

J Trauma Stress. 2022 Nov 3. doi: 10.1002/jts.22889. Online ahead of print.

ABSTRACT

This study explored the impact of moral injury (MI) and posttraumatic stress disorder (PTSD) on health care utilization, mental health complexity, and suicidality in rural and urban veterans. Analyses combined data from the Salt Lake City PTSD Clinic Intake Database and the Department of Veterans Affairs Corporate Data Warehouse. Participants (N = 1,545; Mage = 45.9 years) were predominately male (88.3%) and White (87.8%). Adjusted analyses indicated associations between a 1-unit increase in Moral Injury Events Scale (MIES) score and increased mental health complexity, RR = 1.01, 95% CI [1.01, 1.02], p < .001; psychotropic medication utilization, RR = 1.01, 95% CI [1.01, 1.03], p < .001; VA drug class count, RR = 1.01, 95% CI [1.00, 1.01], p = .030; outpatient utilization, RR = 1.01, 95% CI [1.01, 1.02], p < .001; and mental health outpatient utilization, RR = 1.01, 95% CI [1.00, 1.03], p < .001. For the MIES x PTSD interaction, all associations remained statistically significant with similar estimated effects. However, for rural veterans, this interaction did not significantly affect utilization. Among those with PTSD, a 1-unit MIES increase was associated with an increased risk of suicidality, OR = 1.02, 95% CI [1.01, 1.04], and psychiatric admission, OR = 1.02, 95% CI [1.00, 1.04]. Findings suggest that higher MIES scores predict increased health care utilization and mental health complexity. Further, PTSD combined with higher MIES scores may increase the risk of suicidality and psychiatric admission. Rural veterans with PTSD and higher MIES scores may require additional outreach and intervention.

PMID:36330588 | DOI:10.1002/jts.22889

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Nevin Manimala Statistics

APOE ɛ4 allele and TOMM40-APOC1 variants jointly contribute to survival to older ages

Aging Cell. 2022 Nov 3:e13730. doi: 10.1111/acel.13730. Online ahead of print.

ABSTRACT

Age-related diseases characteristic of post-reproductive life, aging, and life span are the examples of polygenic non-Mendelian traits with intricate genetic architectures. Polygenicity of these traits implies that multiple variants can impact their risks independently or jointly as combinations of specific variants. Here, we examined chances to live to older ages, 85 years and older, for carriers of compound genotypes comprised of combinations of genotypes of rs429358 (APOE ɛ4 encoding polymorphism), rs2075650 (TOMM40), and rs12721046 (APOC1) polymorphisms using data from four human studies. The choice of these polymorphisms was motivated by our prior results showing that the ɛ4 carriers having minor alleles of the other two polymorphisms were at exceptionally high risk of Alzheimer’s disease (AD), compared with non-carriers of the minor alleles. Consistent with our prior findings for AD, we show here that the adverse effect of the ɛ4 allele on survival to older ages is significantly higher in carriers of minor alleles of rs2075650 and/or rs12721046 polymorphisms compared with their non-carriers. The exclusion of AD cases made this effect stronger. Our results provide compelling evidence that AD does not mediate the associations of the same compound genotypes with chances to survive until older ages, indicating the existence of genetically heterogeneous mechanisms. The survival chances can be mainly associated with lipid- and immunity-related mechanisms, whereas the AD risk, can be driven by the AD-biomarker-related mechanism, among others. Targeting heterogeneous polygenic profiles of individuals at high risks of complex traits is promising for the translation of genetic discoveries to health care.

PMID:36330582 | DOI:10.1111/acel.13730

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Nevin Manimala Statistics

The Role of Acidic Urine on Detrusor Pressure in Patients with Overactive Bladder: A Urodynamic Evaluation

Arch Esp Urol. 2022 Oct;75(8):700-705. doi: 10.56434/j.arch.esp.urol.20227508.101.

ABSTRACT

OBJECTIVES: To evaluate the relationship between urine pH value and urodynamic parameters in patients with overactive bladder.

METHODS: The patients’ data whose underwent standard urodynamic study at two tertiary centers in our city. The period between January 2015-January 2021 was reviewed retrospectively. The inclusion criteria were the patients with overactive bladder, over 18 years of age, and with urine analysis before urodynamic study. Patients were divided into two groups as those with acidic urine pH (Group 1) and without (Group 2). The detrusor pressures obtained from filling cystometry were compared between the groups. In addition, the correlation between detrusor pressure and urine pH was examined.

RESULTS: The data from 211 patients (109 females, 102 males) were analyzed during the screening period. Eighty-two patients were in Group 1 and 129 patients in Group 2. The mean age was similar between the groups (p = 0.244). The bladder volume at first sensation of filling and urodynamic maximal bladder capacity was lower in Group 1 than Group 2 (p = 0.004; p < 0.001, respectively). The maximum detrusor pressure was higher in the acidic urine pH group (Group 1, 55.8 ± 20.6) than non-acidic urine pH group (Group 2, 14.5 ± 10.2), and it was statistically significant (p < 0.001). In addition, a significant negative correlation was observed between urine pH level and detrusor pressure (p < 0.001).

CONCLUSIONS: The presence of acidic urinalysis is associated with many urodynamic findings. Significantly, the patients with detrusor overactivity had more acidic urine than without detrusor overactivity. Therefore, for patients with high detrusor pressure, urinalysis should be evaluated carefully.

PMID:36330571 | DOI:10.56434/j.arch.esp.urol.20227508.101

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Analysis of the Predictive Capacity of the Clinical Variables That Indicate the Performance of Voiding Urosonography in the Study of Vesicoureteral Reflux in Children

Arch Esp Urol. 2022 Oct;75(8):693-699. doi: 10.56434/j.arch.esp.urol.20227508.100.

ABSTRACT

INTRODUCTION: Voiding urosonography (VUS) is a dynamic imaging technique which evaluates the lower urinary tract by introducing sonographic contrast into the bladder, preferably used in the diagnosis of vesicoureteral reflux (VUR). Our goals were to describe the clinical indications for performing a VUS for VUR’s diagnosis and analyse its diagnostic reliability.

MATERIAL AND METHODS: Cross-sectional study carried on patients under 15 years old with a VUS taken between November 2013-2020. Sex, age, indications (lower urinary tract infection-LUTI; dilatated lower urinary tract-DLUT; duplex collecting system-DCS), results (presence/absence of VUR, score and side) and complications were analysed. U Mann-Whitney and Chi-squared tests were used and 2 predictive capacity models for the indications used to detect VUR were employed (logistic binomial regression and multilayer perceptron neural network). Statistical significance p < 0.05.

RESULTS: 415 VUS were completed correctly (male 51.8%, median age 7.3 (3.1-15.3) months). Indications were: LUTI (67.5%), DLUT (33.5%) and DCS (10.2%); presenting 1, 2 and 3 indications in 86.5%, 12.8% and 0.7% respectively. VUR was diagnosed in 34.7% cases. A tendency towards statistically significance was showed related to male sex (p = 0.052) and the only significative clinical indication for VUR was DCS (p = 0.007). Patients with 2 simultaneous indications had higher probability of VUR (p = 0.012). DCS presence or male sex were the only predictive variables of VUR: DCS = OR 1.89 (1.54-6.52) (p = 0.006) and male sex = OR 1.56 (1.03-2.35) (p = 0.035).

CONCLUSIONS: VUS is a thriving technique, radiation free and with a low complications rate. Presence of DCS, male sex or 2 simultaneous indications for VUS increase the probability of presenting VUR.

PMID:36330570 | DOI:10.56434/j.arch.esp.urol.20227508.100

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Nevin Manimala Statistics

Diagnostic performance of the Bosniak classification, version 2019 for cystic renal masses: A systematic review and meta-analysis

Front Oncol. 2022 Oct 18;12:931592. doi: 10.3389/fonc.2022.931592. eCollection 2022.

ABSTRACT

PURPOSE: To systematically assess the diagnostic performance of the Bosniak classification, version 2019 for risk stratification of cystic renal masses.

METHODS: We conducted an electronic literature search on Web of Science, MEDLINE (Ovid and PubMed), Cochrane Library, EMBASE, and Google Scholar to identify relevant articles between June 1, 2019 and March 31, 2022 that used the Bosniak classification, version 2019 for risk stratification of cystic renal masses. Summary estimates of sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood ratio (LR-), and diagnostic odds ratio (DOR) were pooled with the bivariate model and hierarchical summary receiver operating characteristic (HSROC) model. The quality of the included studies was assessed with the Quality Assessment of Diagnostic Accuracy Studies-2 tool.

RESULTS: A total of eight studies comprising 720 patients were included. The pooled sensitivity and specificity were 0.85 (95% CI 0.79-0.90) and 0.68 (95% CI 0.58-0.76), respectively, for the class III/IV threshold, with a calculated area under the HSROC curve of 0.84 (95% CI 0.81-0.87). The pooled LR+, LR-, and DOR were 2.62 (95% CI 2.0-3.44), 0.22 (95% CI 0.16-0.32), and 11.7 (95% CI 6.8-20.0), respectively. The Higgins I 2 statistics demonstrated substantial heterogeneity across studies, with an I 2 of 57.8% for sensitivity and an I 2 of 74.6% for specificity. In subgroup analyses, the pooled sensitivity and specificity for CT were 0.86 and 0.71, respectively, and those for MRI were 0.87 and 0.67, respectively. In five studies providing a head-to-head comparison between the two versions of the Bosniak classification, the 2019 version demonstrated significantly higher specificity (0.62 vs. 0.41, p < 0.001); however, it came at the cost of a significant decrease in sensitivity (0.88 vs. 0.94, p = 0.001).

CONCLUSIONS: The Bosniak classification, version 2019 demonstrated moderate sensitivity and specificity, and there was no difference in diagnostic accuracy between CT and MRI. Compared to version 2005, the Bosniak classification, version 2019 has the potential to significantly reduce overtreatment, but at the cost of a substantial decline in sensitivity.

PMID:36330503 | PMC:PMC9623069 | DOI:10.3389/fonc.2022.931592