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Nevin Manimala Statistics

The restoring of interhemispheric brain connectivity following carotid endarterectomy: an exploratory observational study

Brain Imaging Behav. 2022 May 27. doi: 10.1007/s11682-022-00674-1. Online ahead of print.

ABSTRACT

This study aimed to evaluate the differences of brain connectivity between healthy subjects (HS) and patients with extracranial internal carotid artery (eICA) stenosis before and after carotid endarterectomy (CEA). An exploratory prospective study was designed. The study population consisted of a patient group (PG) of 20 patients with eICA stenosis eligible for CEA, and a control group (CG) of 20 HS, matched for age and sex. The subjects of the PG group underwent Magnetic Resonance Imaging (MRI) for resting-state functional connectivity MRI (rs-fc MRI) analysis within one week from the CEA (pre-CEA) and 12 months following CEA (post-CEA). The CG underwent a single MRI with the same protocol utilized for the PG. Three region-of-interest to region-of-interest (ROI-to-ROI) rs-fc MRI analyses were conducted: analysis 1 to compare pre-CEA PG and CG; analysis 2 to compare pre-CEA PG and post-CEA PG; analysis 3 to compare post-CEA PG and CG. The Functional Network Connectivity multivariate parametric technique was used for statistical analysis, adopting a p-uncorrected (p-unc) < 0.05 as connection threshold, and a cluster level False Discovery Rate corrected p (p-FDR) < 0.05 as cluster threshold. The clusters were defined by using a data-driven hierarchical clustering procedure. Analysis 1 revealed two clusters of reduced interhemispheric connectivity of pre-CEA PG when compared to CG. Analysis 2 and 3 showed no statistically significant differences. Our exploratory analysis suggests that patients with eICA stenosis have reduced interhemispheric connectivity when compared to a matched control group, and this difference was not evident anymore following endarterectomy.

PMID:35622267 | DOI:10.1007/s11682-022-00674-1

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A comparative analysis of males and females with breast cancer undergoing mastectomy using the American College of Surgeon’s National Surgical Quality Improvement Project (NSQIP)

Breast Cancer Res Treat. 2022 May 27. doi: 10.1007/s10549-022-06628-x. Online ahead of print.

ABSTRACT

INTRODUCTION: There is a paucity of literature comparing the postoperative outcomes of males and females with breast cancer who undergo mastectomy. The aim of this study is to evaluate the comorbidities and 30-day post-mastectomy complication rates among males and females.

METHODS: We performed a retrospective analysis of breast cancer patients who underwent mastectomy from 2014 to 2016 using the American College of Surgeon’s National Surgical Quality Improvement Project database. Data including patient demographics, comorbidities, and 30-day surgical and medical complications were collected. Statistical analysis included Chi-square and Fisher’s exact tests for categorical variables and Student T-tests for continuous variables. Statistical significance was defined as p < 0.05.

RESULTS: A total of 15,167 patients were identified. There were 497 males (3.3%) and 14,670 females (96.7%). Age was significantly higher in females compared to males (63.5 vs. 57.6 years, p < 0.001). Body mass index (BMI) at time of surgery was also higher in males (30.0 vs. 29.3 kg/m2, p = 0.011). There was a higher prevalence of diabetes in males (20.1 vs. 16.5%, p = 0.032). Operative duration was significantly longer in females (114.9 vs. 95.0 min, p < 0.001). Median postoperative length of stay was also longer in females (1.2 vs. 0.8 days, p < 0.001). There were no significant differences in 30-day medical or surgical complication rates between the two sexes.

CONCLUSION: Our findings suggest that differences in age, BMI, and comorbidities between males and females do not significantly impact 30-day medical or surgical complications following total mastectomy for breast cancer. Further research is warranted to identify perioperative risk factors that influence post-mastectomy complication rates.

LEVEL OF EVIDENCE: 3 (Retrospective cohort study).

PMID:35622242 | DOI:10.1007/s10549-022-06628-x

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Flexible copula model for integrating correlated multi-omics data from single-cell experiments

Biometrics. 2022 May 27. doi: 10.1111/biom.13701. Online ahead of print.

ABSTRACT

With recent advances in technologies to profile multi-omics data at the single-cell level, integrative multi-omics data analysis has been increasingly popular. It is increasingly common that information such as methylation changes, chromatin accessibility, and gene expression are jointly collected in a single-cell experiment. In biomedical studies, it is often of interest to study the associations between various data types and to examine how these associations might change according to other factors such as cell types and gene regulatory components. However, since each data type usually has a distinct marginal distribution, joint analysis of these changes of associations using multi-omics data is statistically challenging. In this paper, we propose a flexible copula-based framework to model covariate-dependent correlation structures independent of their marginals. In addition, the proposed approach could jointly combine a wide variety of univariate marginal distributions, either discrete or continuous, including the class of zero-inflated distributions. The performance of the proposed framework is demonstrated through a series of simulation studies. Finally, it is applied to a set of experimental data to investigate the dynamic relationship between single-cell RNA-sequencing, chromatin accessibility, and DNA methylation at different germ layers during mouse gastrulation. This article is protected by copyright. All rights reserved.

PMID:35622236 | DOI:10.1111/biom.13701

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The GPR35 expression pattern is associated with overall survival in male patients with colorectal cancer

Pharmacol Rep. 2022 May 27. doi: 10.1007/s43440-022-00371-2. Online ahead of print.

ABSTRACT

BACKGROUND: G protein-coupled receptor 35 (GPR35) is involved in the carcinogenesis; however, limited data exist on its relevance for overall survival (OS) and disease-specific survival (DSS) in patients with cancer.

METHODS: We have examined The Cancer Genome Atlas dataset to check the relations between GPR35 expression pattern and OS or DSS of patients with colorectal cancer (CRC).

RESULTS: The performed analysis showed a negative association between positive GPR35 expression Z score and OS in males, which remains statistically significant in advanced stages of colon (COAD) and rectal (READ) adenocarcinoma combined.

CONCLUSIONS: These findings suggest the prognostic value of early testing of GPR35 in male patients with an increased risk of CRC development and warrant further clinical confirmation.

PMID:35622222 | DOI:10.1007/s43440-022-00371-2

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Association of hypoglossal nerve stimulator response with machine learning identified negative effort dependence patterns

Sleep Breath. 2022 May 27. doi: 10.1007/s11325-022-02641-y. Online ahead of print.

ABSTRACT

BACKGROUND: Hypoglossal nerve stimulator (HGNS) is a therapeutic option for moderate to severe obstructive sleep apnea (OSA). Improved patient selection criteria are needed to target those most likely to benefit. We hypothesized that the pattern of negative effort dependence (NED) on inspiratory flow limited waveforms recorded during sleep, which has been correlated with the site of upper airway collapse, would contribute to the prediction of HGNS outcome. We developed a machine learning (ML) algorithm to identify NED patterns in pre-treatment sleep studies. We hypothesized that the predominant NED pattern would differ between HGNS responders and non-responders.

METHODS: An ML algorithm to identify NED patterns on the inspiratory portion of the nasal pressure waveform was derived from 5 development set polysomnograms. The algorithm was applied to pre-treatment sleep studies of subjects who underwent HGNS implantation to determine the percentage of each NED pattern. HGNS response was defined by STAR trial criteria for success (apnea-hypopnea index (AHI) reduced by > 50% and < 20/h) as well as by a change in AHI and oxygenation metrics. The predominant NED pattern in HGNS responders and non-responders was determined. Other variables including demographics and oxygenation metrics were also assessed between responders and non-responders.

RESULTS: Of 45 subjects, 4 were excluded due to technically inadequate polysomnograms. In the remaining 41 subjects, ML accurately distinguished three NED patterns (minimal, non-discontinuous, and discontinuous). The percentage of NED minimal breaths was significantly greater in responders compared with non-responders (p = 0.01) when the response was defined based on STAR trial criteria, change in AHI, and oxygenation metrics.

CONCLUSION: ML can accurately identify NED patterns in pre-treatment sleep studies. There was a statistically significant difference in the predominant NED pattern between HGNS responders and non-responders with a greater NED minimal pattern in responders. Prospective studies incorporating NED patterns into predictive modeling of factors determining HGNS outcomes are needed.

PMID:35622197 | DOI:10.1007/s11325-022-02641-y

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Interleukin 18, soluble cluster of differentiation 40, platelet factor 4 variant 1, and neutrophil gelatinase-associated lipocalin can be used as biomarkers to aid activity and diagnosis in ocular Behçet’s disease

Int Ophthalmol. 2022 May 27. doi: 10.1007/s10792-022-02331-4. Online ahead of print.

ABSTRACT

PURPOSE: The molecules human interleukin (IL-18), the soluble cluster of differentiation (sCD40), platelet factor 4 variant 1 (PF4V1), and neutrophil gelatinase-associated lipocalin (NGAL) are all markers of inflammation in biological systems and are linked to prognosis in several inflammatory diseases as well. Since there is no study in which the above-mentioned molecules are studied together in ocular Behçet’s disease (OBD), the aim of this study is to reveal whether these molecules are activity markers in active (OABD) and inactive (OIBD) disease.

METHODS: 30 OABD and 30 OIBD and 30 healthy individuals were included in the study. IL-18, sCD40, PF4V1, and NGAL molecules were studied in blood samples by the ELISA method.

RESULTS: When OABD and OIBD were compared to healthy individuals, the levels of IL-18, sCD40, PF4V1, and NGAL molecules were found to be statistically significant. These values were even more significantly higher in patients with OABD.

CONCLUSION: When ROC values of IL-18, sCD40, PF4V1, and NGAL are evaluated, it is clear that these four molecules can be used as biomarkers to aid activity and diagnosis in OBD.

PMID:35622217 | DOI:10.1007/s10792-022-02331-4

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Strongly increased risk of gastric and duodenal ulcers among new users of low-dose aspirin: Results from two large cohorts with new-user design

Aliment Pharmacol Ther. 2022 May 27. doi: 10.1111/apt.17050. Online ahead of print.

ABSTRACT

BACKGROUND: Low-dose aspirin is a risk factor for peptic ulcer disease but previous, population-based cohort studies may have underestimated the low-dose aspirin risk because they did not use a new-user design. Gastrointestinal bleeding occurs more frequently early after initiation of low-dose aspirin therapy than in later years.

AIM: To assess the associations of low-dose aspirin with gastric and duodenal ulcer incidence in prevalent- and new-user design.

METHODS: Multivariate Cox regression models in the German ESTHER study (N = 7737) and the UK Biobank (N = 213,598) with more than 10 years of follow-up.

RESULTS: In the prevalent-user design, there was no significant association between low-dose aspirin and gastric ulcer observed in both cohorts. Furthermore, low-dose aspirin was weakly, statistically significantly associated with prevalent duodenal ulcer in the UK Biobank (hazard ratio [95% confidence interval]: 1.27 [1.07-1.51]) but not in the ESTHER study (1.33 [0.54-3.29]). When restricting the exposure to only new users, the hazard ratios for incident gastric and duodenal ulcer disease were 1.82 [1.58-2.11] and 1.66 [1.36-2.04] in the UK Biobank, respectively, and 2.83 [1.40-5.71] and 3.89 [1.46-10.42] in the ESTHER study, respectively.

CONCLUSIONS: This study shows that low-dose aspirin is an independent risk factor for both gastric and duodenal ulcers. The associations were not significant or weak in the prevalent-user design and strong and statistically significant in the new-user design in both cohorts. Thus, it is important to weigh risks against benefits when low-dose aspirin treatment shall be initiated and to monitor adverse gastrointestinal symptoms after the start of low-dose aspirin therapy.

PMID:35621052 | DOI:10.1111/apt.17050

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Physician preferences for attributes of pediatric combination vaccines in the United States

Curr Med Res Opin. 2022 May 27:1-21. doi: 10.1080/03007995.2022.2079262. Online ahead of print.

ABSTRACT

OBJECTIVE: To understand physician preferences for various attributes of pediatric combination vaccines.

METHODS: An online survey was completed by 400 US physicians (pediatricians and family physicians) who routinely administer vaccines to infants aged 1-12 months in outpatient settings. Respondents completed a discrete choice experiment (DCE) by selecting their preferred options from different hypothetical vaccine profiles with systematic variation in the levels of five attributes: vaccine presentation, number of injections administered at a single visit, completion rates, timeliness rates (within 30 days of recommended age), and years of availability for routine use, assuming similar cost, safety, and efficacy. Odds ratios and relative attribute importance scores were estimated using a random parameters logit model.

RESULTS: Physicians (mean age 50.40 years, 52.5% women) preferred combination vaccines that reduced the number of injections administered at a single visit, facilitated higher completion and timeliness rates for the primary DTaP series, were available as a pre-filled syringe rather than vial for reconstitution, and had been available for routine use for more than 1 year. All odds ratios were statistically significant. Physicians were twice as likely to prefer administering 2 injections in a single visit instead of 3. The most important attribute was the number of injections administered at a single visit (relative importance 38%), followed by timeliness, completion rates, and vaccine presentation; years a vaccine has been available was the least important.

CONCLUSION: US physicians prefer pediatric combination vaccines that enable fewer injections to be administered at a single visit, facilitate higher completion and timeliness rates, are offered as a pre-filled syringe, and have been available for routine use for more than 1 year. The most important attribute of pediatric combination vaccines was a reduction in the number of injections administered at a single visit.

PMID:35621019 | DOI:10.1080/03007995.2022.2079262

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A comparison of country-level data from the VISIONARY study examining treatment outcomes with preservative-free tafluprost/timolol fixed-dose combination therapy

Curr Med Res Opin. 2022 May 27:1-32. doi: 10.1080/03007995.2022.2083324. Online ahead of print.

ABSTRACT

OBJECTIVE: Analysis and comparison of country-level data from the VISIONARY study, examining treatment outcomes with the topical fixed-dose combination of preservative-free tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) who were insufficiently treated with or unable to tolerate either beta-blocker or prostaglandin analogue (PGA) topical monotherapy.

METHODS: A European, prospective, observational study was conducted in 11 countries. Adults with OAG/OHT were switched to the PF tafluprost/timolol FC from either PGA or beta-blocker topical monotherapy. Statistical analysis examined changes in mean standard deviation (SD) intraocular pressure (IOP) from baseline at Week 4, Week 12 and Month 6. Data were documented for each eye separately at baseline and during follow up visits, with the eye reported to have the higher IOP (mmHg), as measured using Goldmann applanation tonometry, being selected for analysis (study eye). Country-level subanalysis examined outcomes by prior monotherapy, diagnosis and timing of dosing for those countries recruiting ≥20 patients (Country-level Subanalysis Population). Two-sided paired t-test was used to assess significance regarding mean IOP reduction from baseline and a compound symmetry covariance model was used in cross-country comparisons regarding variation in IOP change from baseline. Treatment-related adverse events (AEs) were evaluated.

RESULTS: Mean (SD) age among patients recruited to the VISIONARY study ranged between 63.9 (11.8) to 72.4 (10.6) years across all countries. The majority of participants (>50%) were female in each country. The Country-level Subanalysis Population included 551 eyes. Mean (SD) IOP was significantly reduced from baseline in each country at Week 4, Week 12 and Month 6 (p < 0.0001). Mean IOP reduction at Month 6 ranged from 5.0 mmHg (22.6%, Hungary) to 7.8 mmHg (31.8%, Latvia) and varied significantly between countries (p < 0.001). The greatest reductions were in Latvia and Russia, where baseline IOP was highest. Country-level IOP reductions were significant irrespective of prior monotherapy, diagnosis or dosing time (p < 0.0001). Most treatment-related AEs occurred in the UK (26 events, 73% mild). One serious AE was reported (Russia, status asthmaticus). Tolerability with PF tafluprost/timolol FC therapy was rated as good/very good by most patients (85.7-100%) in all countries.

CONCLUSION: Subanalysis of VISIONARY study data revealed significant IOP reductions following a switch to the PF tafluprost/timolol FC from either PGA or beta-blocker topical monotherapy. Cross-country variation was likely due to baseline IOP differences. Within country, outcomes were consistent regardless of diagnosis, dosing or prior monotherapy. Treatment was generally well tolerated.

PMID:35621005 | DOI:10.1080/03007995.2022.2083324

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Profile of self-concept and self-esteem on the academic performance among practitioners of physical education and extracurricular activities in middle-school students

Minerva Pediatr (Torino). 2022 May 27. doi: 10.23736/S2724-5276.22.06766-0. Online ahead of print.

ABSTRACT

BACKGROUD: The deprivation of components that exercise the body and mind by children and adolescents can lead to numerous long-term consequences in terms of physical health (cardiovascular diseases, bone problems, high cholesterol, obesity) and mental health (depression, low self-esteem and social isolation).

METHODS: This investigation intended to identify a profile of self-concept and self-esteem, on the academic performance of middle-school children between practitioners of curricular physical education and extracurricular sport activities. The participants consisted of a total of 107 students, 55 (51.4%) were males and 52 (48.6%) were female, aged between 10 and 12 years. A total of 41 children (38.3%) attending the fifth grade and 66 children (61.7%) the sixth grade were randomly selected. The data collection instrument, Self-concept of Susan Harter validated for the Portuguese population was used and it was proceeded to a descriptive and inferential statistics data analysis to confront the mean levels of self-concept, global self-esteem and academic performance.

RESULTS: As an influence of hours of weekly practice, we found statistically significant differences in terms of academic performance, that is, as the student practices more hours of physical exercise, there is a tendency for the student to obtain better academic results.

CONCLUSIONS: Apparently, the practice of extracurricular sport activities by students promotes a significant evolution in the formation of self-concept and academic performance, as well as suggesting a positive evolutionary trend in the formation of self-esteem of students who practice the several extracurricular sports.

PMID:35620993 | DOI:10.23736/S2724-5276.22.06766-0