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Nevin Manimala Statistics

Correlation of female age with outcome of IVF in a low-resource setting

Int J Gynaecol Obstet. 2022 Nov 4. doi: 10.1002/ijgo.14545. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the effect of female age on pregnancy outcome after in vitro fertilization/embryo transfer (IVF-ET).

METHODS: A prospective study was conducted involving 266 women who had IVF-ET at Nisa Fertility and Genetic Center, Abuja, Nigeria. All eligible consenting women were recruited to the study. The main outcome measure was clinical pregnancy. Data were analyzed using IBM SPSS Statistics version 25. P<0.05 at 95% confidence intervals was taken as significant.

RESULTS: A total of 266 patients were recruited and included in the study; 104 pregnancies were recorded, giving an overall pregnancy rate of 39.1%. The age range of the patient was 26-43 years (mean age 33.9±2.41 years) while the mean number of embryo transfers per patient was 2.2. The clinical pregnancy rate for women aged below 30 years was 69.4% while the pregnancy rate for patients aged 30-34 years, 35-39 years, and 40-43 years was 52.6%, 24.7%, and 9.4%, respectively (P<0.0001) CONCLUSION: The study found that the success rate of IVF-ET decreases significantly in women aged over 34 years. Women should be counseled about the age-related risk of infertility and referred to a fertility center as early as possible.

PMID:36330818 | DOI:10.1002/ijgo.14545

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Nevin Manimala Statistics

Late diagnosis of CHD and its associated factors in Kenya: an analytic cross-sectional study

Cardiol Young. 2022 Nov 4:1-7. doi: 10.1017/S1047951122003353. Online ahead of print.

ABSTRACT

INTRODUCTION: Burden of CHD in Africa is generally underestimated mainly due to significant under-reporting and early-related fetal and neonatal mortality.

OBJECTIVES: Determine the prevalence and factors associated with late diagnosis of CHD seen at three tertiary care hospitals in Kenya.

DESIGN: A cross-sectional study on paediatric patients with CHDs, aged 0-18 years, seen over a 5-year period, between January, 2011 and December, 2016.

SETTING: Aga Khan University Hospital Nairobi, Mater Hospital, and Kenyatta National Hospital.

METHODS: Patients were stratified into those diagnosed late (>1 year of age) and those diagnosed early (<1 year of age). Multiple logistic regression analysis was done to determine factors associated with late diagnosis.

RESULTS: The study enrolled 411 patients, with equal gender distribution. Prevalence of late diagnosis (>1 year of age) of CHD was 60.6% (95% CI 55.7-65.3). Median age at diagnosis was 15 (IQR 5-48) months. Presence of a cardiac murmur (OR = 0.87; 95% CI 0.72-0.92, p-value = 0.016) and level of parental education (OR = 4.99; 95% CI 2.25-11.40, p-value <0001) were associated with a decreased odds of late diagnosis. Other factors like cyanosis, an increase in the number of healthcare workers and healthcare facilities per 10,000 population showed some association with decreased odds of late diagnosis of CHD, but these were not statistically significant.

CONCLUSION: Late diagnosis of CHD remains alarmingly high in our setting. Initiatives to enhance early detection and screening of CHD should be adopted to reduce related mortality and morbidity.

PMID:36330814 | DOI:10.1017/S1047951122003353

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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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Nevin Manimala Statistics

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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Nevin Manimala Statistics

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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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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Nevin Manimala Statistics

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