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Nevin Manimala Statistics

Safety and Efficacy of Direct-acting Antiviral Therapies for Chronic HCV Infection in Hemodialysis Patients

In Vivo. 2022 Nov-Dec;36(6):2918-2922. doi: 10.21873/invivo.13033.

ABSTRACT

BACKGROUND/AIM: The aim of this study was to determine the safety and efficacy of a direct-acting antiviral treatment, ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, in a real-life setting.

PATIENTS AND METHODS: We performed a prospective observational study including 108 patients undergoing hemodialysis for end-stage kidney disease, referred to our clinic for antiviral therapy for chronic hepatitis C virus infection. Patients received treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir, for 12 weeks. Sustained virologic response (SVR) was defined as undetectable viremia at 12 weeks after the end of therapy. For safety analysis, we monitored serum levels of hemoglobin, albumin, total bilirubin, alanine-aminotransferase and aspartate- aminotransferase at the beginning and end of therapy, as well as at SVR. Verbal Numeric Rating Scale was used to assess the presence of nausea, headaches and fatigue.

RESULTS: We noted a high prevalence of diabetic and hypertensive nephropathy as the underlying cause of chronic kidney disease. Most of the patients had F2 and F3 liver fibrosis (32.40% and 34.25%, respectively). The SVR rate was 96.2% (103/107 patients). We recorded an unrelated death after the completion of antiviral therapy. We found increased levels of nausea, headaches and fatigue at the end of therapy compared to at initiation, The presence and degree of symptoms did not correlate with the underlying cause of renal disease (p=0.72) nor with the degree of fibrosis (p=0.08). Minimal increases in transaminases and bilirubin were recorded at the end of treatment, with no statistical significance.

CONCLUSION: Oral antiviral therapy with ombitasvir/paritaprevir/ritonavir and dasabuvir can be safely used in hemodialysis patients, with similar response rates compared to the general population.

PMID:36309363 | DOI:10.21873/invivo.13033

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Nevin Manimala Statistics

The Incidence and Effect of COVID-19 Vaccine Adverse Events on Breakthrough Infections: Decentralized Observational Study that Includes Underrepresented Groups

JMIR Form Res. 2022 Oct 29. doi: 10.2196/41914. Online ahead of print.

ABSTRACT

BACKGROUND: Despite continuing efforts to improve inclusion of underserved groups in clinical research, gaps in diversity remain. Participation of special populations is especially important when facing problems of unprecedented complexity such as COVID-19. A better understanding of factors associated with immune response in diverse populations would advance future preventive and curative approaches.

OBJECTIVE: The objective of this study was to investigate the factors potentially responsible for adverse events following the COVID-19 immunization. The population of the study included adults from rural areas, developing countries, and those with medically understudied conditions, across a broad age range.

METHODS: The study evolved from peer-support networks developed during the COVID-19 pandemic. Participants were recruited digitally through online neighborhood and health communities. Some of the participants volunteered as study investigators assisting with off-line recruitment and safety monitoring. Individuals who consented to participate were asked to share their vaccination experiences either using constantly-evolving online surveys or via one-to-one communication. Inferential statistics to estimate differences between study groups was performed using parametric and non-parametric tests.

RESULTS: Of 1430 participants who shared their vaccination experiences, 648 had outcome measures at their 1.5-year follow-up. Statistically significant differences were found between age groups, types of vaccine adverse events (VAEs), incidences of breakthrough infections and health conditions linked to the microbiome. Pairwise comparisons showed that VAEs interfering with daily activities were significantly higher in both younger (18-59) and older groups (80-100, P < .001) when compared to the 60-79 age bracket. Short term VAEs were associated with lower incidence of breakthrough COVID-19 relative to those who reported either minimal or long-term adverse events (P < .001). A genetic origin was suggested for some adverse reactions.

CONCLUSIONS: The findings of this study demonstrate that vaccine adverse reactions in the elderly are being overlooked and the incidence of VAEs impairing immunity may be higher than previously thought. Better preventive measures are needed for all those at risk for life-threatening and long-term adverse events of vaccination. Supportive community-based studies focusing on these populations could add important data to the body of knowledge. Further and more comprehensive studies should follow.

CLINICALTRIAL: ClinicalTrials.gov NCT04832932; https://clinicaltrials.gov/ct2/show/NCT04832932.

INTERNATIONAL REGISTERED REPORT: RR2-10.1101/2021.06.28.21256779.

PMID:36309347 | DOI:10.2196/41914

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Nevin Manimala Statistics

Failure of internal cerebrospinal fluid shunt: a systematic review and meta-analysis of the overall prevalence in adult

World Neurosurg. 2022 Oct 26:S1878-8750(22)01490-5. doi: 10.1016/j.wneu.2022.10.073. Online ahead of print.

ABSTRACT

OBJECTIVE: Reported rates of failures varies greatly from below 5% up to over 50% and, no meta-analysis to assess the overall prevalence has ever been performed. Herein, the authors estimated the failure rate after internal CSF shunt (ICSFS) insertion and searched for associated factors.

METHODS: Six databases were searched from January 1990 to February 2022. Only original articles reporting the rate of adult shunt failure were included. Random-effects meta-analysis with generalised linear mixed model method and logit transformation was used to compute the overall failure prevalence. Subgroup analysis and meta-regression were implemented to search for associated factors.

RESULTS: Of 1,763 identified articles, 46 were selected, 70,859 ICSFS implantations and for 13,603 shunt failure, suggesting an accumulated incidence of 19.2%. However, the calculated pooled prevalence value and its 95% confidence interval (CI) were 22.7% 95%CI[19.8-5.8]. The CI of the different estimates did not overlap, indicating a strong heterogeneity confirmed by a high I2 of 97.5%, 95%CI[97.1-97.8], p<0.001 with a τ2=0.3. Ninety-five percent prediction interval of shunt failure prevalence ranged from 8.75% up to 47.36%. A meta-regression of prevalence by year of publication found a barely significant decreasing failure rate of about two percent per year (-2.11, 95%CI[-4.02- -0.2], p-value=0.031).

CONCLUSION: Despite being a quite simple neurosurgical procedure, ICSFS insertion has one of the highest risk of complications with failure prevalence involving more than 1 patient out of 5. Nonetheless, all the efforts to lower these frustrating high level of shunt failure seem to be effective.

TRIAL REGISTRATION: This meta-analysis is registered in https://www.crd.york.ac.uk/PROSPERO/, PROSPERO ID: CRD42022339954.

PMID:36309337 | DOI:10.1016/j.wneu.2022.10.073

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Nevin Manimala Statistics

The Influence of Roussouly Type on the Prevalence, Subtype and Distribution Characteristics of Modic Changes in Patients with Lumbar Degenerative Disc Disease

World Neurosurg. 2022 Oct 26:S1878-8750(22)01487-5. doi: 10.1016/j.wneu.2022.10.070. Online ahead of print.

ABSTRACT

BACKGROUND: The relationship between Roussouly type and Modic changes (MCs) is unknown. Thus, the aim of our study was to investigate the influence of Roussouly type on the characteristics of MCs in patients with lumbar degenerative disc disease (LDD).

METHODS: This cross-sectional observational study included 270 patients with LDD from Huashan Hospital. All the subjects were divided into four groups according to the Roussouly classification. The prevalence, subtype and distribution characteristics of MCs from L1-L2U to L5-S1L were compared between four Roussouly types.

RESULT: A total of 270 patients were included in our study, 65 cases (24.1%) of Roussouly type Ⅰ, 115 cases (42.6%) of Roussouly type Ⅱ, 55 cases (20.4%) of Roussouly type Ⅲ, and 35 cases (13.0%) of Roussouly type Ⅳ. MCs were present in 45.9% (n=270) subjects, 12.7% (n=2700) endplates and 11.8% (n=1350) intervertebral discs. The prevalence rate of MCs by subtype and intervertebral disc among four Roussouly types was statically different (P<0.05) and the prevalence rate of MCs by intervertebral disc in Roussouly type Ⅰ was statistically higher than other three Roussouly types. In Roussouly type Ⅰ and Ⅳ, the prevalence rate of MCs at L4-L5 level showed no significant differences compared with those at upper lumbar levels while in Roussouly type Ⅱ and Ⅲ, the prevalence rate of MCs at L4-L5 level was significantly higher than those at upper lumbar levels.

CONCLUSION: We concluded that Roussouly types can influence the prevalence, subtype and distribution characteristics of MCs in patients with LDD.

PMID:36309336 | DOI:10.1016/j.wneu.2022.10.070

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Nevin Manimala Statistics

Spatially-enhanced clusterwise inference for testing and localizing intermodal correspondence

Neuroimage. 2022 Oct 26:119712. doi: 10.1016/j.neuroimage.2022.119712. Online ahead of print.

ABSTRACT

With the increasing availability of neuroimaging data from multiple modalities-each providing a different lens through which to study brain structure or function-new techniques for comparing, integrating, and interpreting information within and across modalities have emerged. Recent developments include hypothesis tests of associations between neuroimaging modalities, which can be used to determine the statistical significance of intermodal associations either throughout the entire brain or within anatomical subregions or functional networks. While these methods provide a crucial foundation for inference on intermodal relationships, they cannot be used to answer questions about where in the brain these associations are most pronounced. In this paper, we introduce a new method, called CLEAN-R, that can be used both to test intermodal correspondence throughout the brain and also to localize this correspondence. Our method involves first adjusting for the underlying spatial autocorrelation structure within each modality before aggregating information within small clusters to construct a map of enhanced test statistics. Using structural and functional magnetic resonance imaging data from a subsample of children and adolescents from the Philadelphia Neurodevelopmental Cohort, we conduct simulations and data analyses where we illustrate the high statistical power and nominal type I error levels of our method. By constructing an interpretable map of group-level correspondence using spatially-enhanced test statistics, our method offers insights beyond those provided by earlier methods.

PMID:36309332 | DOI:10.1016/j.neuroimage.2022.119712

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Gestational exposure to perfluoroalkyl substances is associated with placental DNA methylation and birth size

Sci Total Environ. 2022 Oct 26:159747. doi: 10.1016/j.scitotenv.2022.159747. Online ahead of print.

ABSTRACT

DNA methylation is one potential mechanism for the effects of gestational exposure to perfluoroalkyl substances (PFASs) on fetal growth. We investigated 180 pregnant women who participated in a cohort study conducted in Tangshan City, Northern China, and determined the concentrations of 11 PFASs and the methylation of two genes related to fetal growth [insulin-like growth factor 2 (IGF2) and nuclear receptor subfamily 3 group C member 1 (NR3C1)] and one surrogate marker for global methylation [long interspersed nuclear element-1 (LINE-1)] in placenta tissue. Multiple linear regression analysis was performed to examine the associations of log transformed PFASs with the DNA methylation and birth size. Weighted quantile sum regression was used to determine the mixture effect of PFASs. After adjusting for potential confounders, perfluorooctane sulfonate (PFOS) was negatively associated with the overall methylation of LINE-1. PFASs mixture was negatively associated with the methylation of all CpG loci of LINE-1 and overall methylation of NR3C1. Perfluorootanoic acid (PFOA), perfluorononanoic acid (PFNA), perfluorodecanoic acid (PFDA), and the PFASs mixture showed negative associations with head circumference. After stratified by newborns’ sex, PFOA, PFNA and the PFASs mixture was negatively associated with overall methylation of LINE-1 only in the male subgroup and the methylation of all CpG loci of LINE-1 was negatively associated with ponderal index only in the female subgroup. The interaction of newborns’ sex with PFOS and PFOA on overall methylation of IGF2 was statistically significant and so was the interaction of sex with PFOS on overall methylation of LINE-1. These findings suggested that intrauterine exposure to PFASs affected placental DNA methylation and reduced fetal growth, which might be modified by sex.

PMID:36309289 | DOI:10.1016/j.scitotenv.2022.159747

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Nevin Manimala Statistics

Assessment of natural and anthropogenic contamination sources in a Mediterranean aquifer by combining hydrochemical and stable isotope techniques

Sci Total Environ. 2022 Oct 26:159763. doi: 10.1016/j.scitotenv.2022.159763. Online ahead of print.

ABSTRACT

The Atalanti basin is an intensively cultivated area in central Greece, facing groundwater quality deterioration threats due to natural and anthropogenic-related contamination sources. A combination of statistical and hydrogeochemical techniques, and stable isotope compositions (δ2H-H2O and δ18Ο-Η2Ο, δ15Ν-ΝΟ3 and δ18Ο-ΝΟ3, δ34S-SO42- and δ18O-SO42-) were applied to elucidate the origin of salinity and nitrate contamination, and shed light on the potential associations between geogenic Cr(VI) and NO3 sources and transformations. Nitrate and Cr(VI) concentrations reached up to 337 mg L-1 and 76.1 μg L-1, respectively, exceeding WHO threshold values in places. The cluster of samples with the high salinity was mostly influenced by irrigation return flow and marine aerosols, and less by seawater intrusion, as evidenced by the ionic ratios (e.g., Na+/Cl) and the stable isotopes of oxygen and hydrogen in water, and sulphur and oxygen in sulphates. The δ15Ν-ΝΟ3 and δ18O-NO3 values ranged from +2.0 ‰ to +14.5 ‰ and + 0.3 ‰ to +11.0 ‰, respectively. We found that the dominant sources of NO3 in groundwater were fertilizers in the central part of the area and sewage waste in the northern part around the residential area of Livanates. The occurrence of denitrification was evident in the northern part of the basin, where the DO levels were lowest (≤ 2.2 mg L-1), whereas nitrification of NH4+-fertilizers prevailed in the central part. High Cr(VI) values (≥ 20 μg/l) were associated with the lowest deviation of the measured from the theoretical nitrification δ18Ο-NO3 values, whereas the lowest Cr(VI) values were observed in the denitrified water samples. Our isotope findings revealed the strong influence of redox conditions on the biogeochemical transformations of N species and the mobilization of Cr(VI) that will help improve the understanding of the fate of these contaminants from the unsaturated zone to the groundwater in areas of agricultural and urban land use.

PMID:36309271 | DOI:10.1016/j.scitotenv.2022.159763

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Untargeted analysis of environmental contaminants in surface snow samples of Svalbard Islands by liquid chromatography-high resolution mass spectrometry

Sci Total Environ. 2022 Oct 26:159709. doi: 10.1016/j.scitotenv.2022.159709. Online ahead of print.

ABSTRACT

In recent years, there is increasing attention on the contaminants of emerging concern (CECs), which include plasticizers, flame retardants, industrial chemicals, pharmaceuticals, and personal care products, since they have been detected even far away from pollution sources. The polar regions are not exempt from the presence of anthropogenic contaminants, and they are employed as a model for understanding the pollutant fate and impact. During the 2021 spring campaign, sixteen surface snow samples were collected close to the research station of Ny-Ålesund located on the Spitsbergen Island of the Norwegian Svalbard Archipelago. The samples were extracted by solid-phase extraction and analyzed by liquid chromatography-high-resolution tandem mass spectrometry (LC-HRMS/MS) following an untargeted approach. Compound tentative identification was obtained with the aid of the software Compound Discoverer, using both mass spectral database search and manual validation. Among the 114 compounds identified with a high confidence level in the snow samples, >80 have some commercial or industrial use (drugs, plasticizers, fragrances, etc.), therefore they could be of anthropogenic origin. Nonetheless, a clear contamination trend did not appear in the snow samples collected on eight different days during one month. The comparison with aerosol samples collected in the same area did not help identifying the source, either, since only a few compounds were in common, and they were mainly of natural origin. As such, the analysis of aerosol sample did not support possible long-range transport, also considering that compounds were detected mostly in the coarse fraction.

PMID:36309265 | DOI:10.1016/j.scitotenv.2022.159709

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Nevin Manimala Statistics

Concurrent Psychosocial Concerns and Post-Concussive Symptoms Following Pediatric mTBI: An A-CAP Study

J Pediatr Psychol. 2022 Oct 29:jsac076. doi: 10.1093/jpepsy/jsac076. Online ahead of print.

ABSTRACT

OBJECTIVES: To measure the association between psychosocial problems and persistent post-concussive symptoms (PCS) in youth who were seen in the emergency department with mild traumatic brain injury (mTBI) or orthopedic injury (OI).

METHODS: From a larger prospective cohort study, Advancing Concussion Assessment in Pediatrics (A-CAP), 122 child-guardian pairs who presented to the emergency department with mTBI (N = 70) or OI (N = 52) were recruited for this cross-sectional sub-study. Each pair completed 2 measures assessing PCS burden at 2 weeks, 3 months, and 6 months post-injury. At one visit, pairs concurrently completed MyHEARTSMAP, a comprehensive, psychosocial self-assessment tool to evaluate 4 domains of mental wellness.

RESULTS: When measured at the same visit, children who self-reported moderate or severe Psychiatry domain concerns concurrently experienced a greater burden of cognitive symptoms (β = 5.49; 0.93-10.05) and higher overall PCS count (β = 2.59; 0.70-4.48) after adjusting for covariables, including retrospective pre-injury symptoms and injury group. Additionally, reports indicating mild Function domain severity were associated with increased cognitive (β = 3.34; 95% CI: 0.69-5.99) and somatic symptoms (β = 6.79; 2.15-11.42) and total symptom count (β = 1.29; 0.18-2.39).

CONCLUSION: Increasing severity in multiple domains of mental health is associated with more PCS in youth. While the differences in PCS between the mTBI and OI groups appeared somewhat larger for children with more mental health concerns, the interaction was not statistically significant; larger sample sizes are needed to evaluate the moderating effect of psychosocial difficulties on post-concussion symptoms.

PMID:36308773 | DOI:10.1093/jpepsy/jsac076

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Preliminary Validation of the Psychosocial Assessment Tool in the Neonatal Intensive Care Unit

J Pediatr Psychol. 2022 Oct 29:jsac081. doi: 10.1093/jpepsy/jsac081. Online ahead of print.

ABSTRACT

OBJECTIVE: Research suggests families whose infants are admitted to the Neonatal Intensive Care Unit (NICU) experience elevated distress and may have pre-existing risk factors for maladjustment. This study sought to validate the newly developed Psychosocial Assessment Tool (PAT-NICU/Cardiac Intensive Care Unit [CICU]), a comprehensive screening measure for family psychosocial risk in the NICU.

METHODS: The sample included 171 mothers, who completed the PAT-NICU/CICU and other related measures within 2 weeks of their infant’s NICU admission at a level 4 unit within a large pediatric hospital. PAT-NICU/CICU scores were compared to a companion risk survey completed by NICU social workers. Test-retest reliability was assessed through repeated measures at 2-month follow-up.

RESULTS: Analyses suggest the PAT-NICU/CICU is effective in classifying psychosocial risk. This is supported by statistically significant correlations between the PAT-NICU/CICU and validated measures, in addition to elevated scores on concurrent measures by risk classification. Internal consistency, test-retest reliability, and acceptability for the PAT-NICU/CICU were satisfactory.

CONCLUSIONS: This preliminary study demonstrates the validity, reliability, and acceptability of the PAT-NICU/CICU as a psychosocial screening tool to aid identification of families who may benefit from supportive services during NICU admission. This new measure is a more comprehensive tool that assesses a wide variety of risk factors and stress responses. However, future studies of this measure are needed with more diverse samples. Prompt screening of NICU parents may facilitate earlier linkage with appropriate levels of resources or intervention. This research is crucial in improving risk assessment and psychosocial care for families in the NICU.

PMID:36308772 | DOI:10.1093/jpepsy/jsac081