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Nevin Manimala Statistics

Dietary intake of Spirulina platensis alters HSP70 gene expression profiles in the brain of rats in an experimental model of mixed stress

J Genet. 2022;101:49.

ABSTRACT

Spirulina platensis has gradually gained more attention for its therapeutic, antioxidant, and anti-inflammatory potential worldwide. However, the current molecular knowledge about the effects of spirulina on stress-related genes is rather limited. The effects of dietary intake of spirulina on the HSP70 gene expression were assessed in a controlled in vivo experimental design. Moreover, alterations in serum corticosterone levels, IL-2, IL-4, IFN-Υ, triglyceride, ALT, AST, relative gene expression values, and the correlations between them were evaluated. A total of 36 rats were divided into four groups: control group, stress-only group, spirulina group, and spirulina+stress group. To control the dose administration, S. platensis was applied by a gastric gavage in stress groups. Crowded environment stress and hosting alone stress were applied to the stress-only group and spirulina + stress group. RNA was extracted from brain samples using TRIpure and the relative gene expression assessment was performed using Roche-LightCycler-480-II real-time PCR-System. Gene expression values were remarkably different among the four experimental groups. The differences between stress-only and the spirulina groups were statistically significant (P<0.05). The correlation between the HSP70 gene expression and the IFN-Υ was found to be statistically significant (P<0.05; r=0.50). Results indicate a novel effect of spirulina on the HSP70 expression related to the stress-response. Data presented in this study may be useful for further studies to define not only the molecular genetic aspects through dietary S. platensis but also the effects of spirulina on stress-response and animal welfare.

PMID:36330789

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Evaluation of the interchangeability between the new fully-automated affinity chrome-mediated immunoassay (ACMIA) and the Quantitative Microsphere System (QMS) with a CE-IVD-certified LC-MS/MS assay for therapeutic drug monitoring of everolimus after solid organ transplantation

Clin Chem Lab Med. 2022 Nov 4. doi: 10.1515/cclm-2022-0699. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aims to evaluate the interchangeability between the Siemens Healthineers’ “EVRO” new affinity chrome-mediated immunoassay (ACMIA/EVRO) and Thermo Fisher Scientific’s “EVER” Quantitative Microsphere System (QMS/EVER) with Chromsystems’ CE-IVD-certified “MassTox” liquid-chromatography/tandem-mass spectrometry (LC-MS/MS) assay for the therapeutic drug monitoring of everolimus.

METHODS: A single lot of reagent, calibrators and controls were used for each assay. A total of 67 whole blood samples (n=67) from patients receiving solid organ transplant were analyzed (n=31 with kidney transplant and n=36 with liver transplant); Passing-Bablok regression and Bland-Altman difference plot were used to evaluate bias and individual agreement; LC-MS/MS analysis was used to measure the actual concentrations of calibrators and controls compared to the assigned value.

RESULTS: ACMIA/EVRO did not show any systematic bias compared to LC-MS/MS (intercept=0.244 ng/mL, 95% CI: -0.254 to 0.651 ng/mL). Nevertheless, significant proportional bias (slope=1.511, 95% CI: 1.420 to 1.619) associated to a combined bias of 44.8% (95% CI: 41.2-48.3%) was observed. Conversely, QMS/EVER did not show any bias at both systematic (intercept=-0.151 ng/mL, 95% CI: -0.671 to 0.256 ng/mL) and proportional level (slope=0.971, 95% CI: 0.895 to 1.074) with a non-statistically significant combined bias of -3.6% (95% CI: -8.4-1.1%). Based on a concentration of calibrators and controls above the assigned value for both the analytical methods, in the ACMIA/EVRO a correction which was approximately one-third of the correction for the QMS/EVER was observed.

CONCLUSIONS: ACMIA/EVRO but not QMS/EVER shows a lack of interchangeability with the CE-IVD-certified LC-MS/MS assay. We hypothesize that, as the ACMIA/EVRO uses an anti-sirolimus antibody, the under-corrected assigned value in the assay calibrators was not sufficient to reproduce the everolimus metabolites cross-reactivity occurring in real samples.

PMID:36330751 | DOI:10.1515/cclm-2022-0699

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Incidence and associated factors of pediatric post-intensive care syndrome using the VSCAREMD model

Acute Crit Care. 2022 Oct 19. doi: 10.4266/acc.2022.00234. Online ahead of print.

ABSTRACT

BACKGROUND: A novel comprehensive model called the VSCAREMD model has been proposed to detect post-intensive care syndrome (PICS) in children. This study aimed to outline the incidence of PICS in children using the VSCAREMD model and to describe the associated factors.

METHODS.: All children ages 1 month to 15 years and admitted to the intensive care unit for at least 48 hours were evaluated using the VSCAREMD model within 1 week of intensive care discharge. The VSCAREMD model is used for evaluating vaccination, sleep, and parental care burden, which includes daily activity and social interaction, rehabilitation requirements, hearing, mood, and development. Abnormal findings were assorted into four domains: physical, cognitive, mental, and social. Descriptive statistics were performed using chi-square, univariate, and multivariate analyses.

RESULTS.: A total of 78 of 95 children (82.1%) had at least one abnormal domain. Physical, cognitive, mental, and social morbidity were found in 64.2%, 26.3%, 13.7%, and 38.9% of the children, respectively. Prolonged intensive care unit stay greater than 7 days was associated with dysfunction in physical (adjusted odds ratio [aOR], 3.80; 95% confidence interval [CI], 1.31-11.00), cognitive (aOR, 10.11; 95% CI, 3.01-33.89), and social domains (aOR, 5.01; 95% CI, 2.01-12.73). Underlying medical conditions were associated with cognitive (aOR, 13.63; 95% CI, 2.64-70.26) and social morbidity (aOR, 2.81; 95% CI, 1.06-7.47).

CONCLUSION.: : The incidence of PICS using the VSCAREMD model was substantially high and associated with prolonged intensive care. This model could help evaluate PICS in children.

PMID:36330737 | DOI:10.4266/acc.2022.00234

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Nevin Manimala Statistics

Frequentist against Bayesian statistics: tug of war!

Acute Crit Care. 2022 Oct 21. doi: 10.4266/acc.2022.00850. Online ahead of print.

NO ABSTRACT

PMID:36330736 | DOI:10.4266/acc.2022.00850

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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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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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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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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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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