Category: Statistics

Environ Sci Pollut Res Int. 2023 Aug 24. doi: 10.1007/s11356-023-29254-6. Online ahead of print.

ABSTRACT

Fluoride pollution is a major issue worldwide, posing health risks such as dental and skeletal fluorosis. This study was conducted in fluoride enrichment hard rock regions of Vaniyambadi and Ambur talks in Tirupathur district, Tamil Nadu. Four hundred eighty groundwater samples were collected from May 2021 to April 2022 and grouped as summer, southwest monsoon (SWM), northeast monsoon (NEM), and winter. Maximum concentration of fluoride was found to be 4 mg/L in the summer season in Vellakuttai region of Vaniyambadi taluk. The study aims to investigate the hydrogeochemical process and mechanism influencing groundwater chemistry and it also provides the confirmation of exploratory data analysis in groundwater quality using structural equation modeling. The Piper and Gibbs diagrams illustrate the rock-water interaction and anthropogenic sources that contribute to the NaHCO₃ and NaCl-type waters, respectively. Multivariate statistical analysis such as hierarchical cluster analysis (HCA), principal component analysis (PCA), multiple linear regression (MLR), and structural equation modeling (SEM) has been carried out to determine the groundwater quality. HCA manifests the nature and sources of groundwater, whereas PCA divides all the physicochemical parameters into two PC loadings, accounting for 97.46%, 99.46%, 99.18%, and 98.93% of cumulative % of variance during the summer, SWM, NEM, and winter seasons, respectively. PC1 has a higher loading factor to Cl, Ca, and Mg, whereas PC2 has a higher loading factor to Na, HCO₃, SO₄, and NO₃. The results of the MLR model provide higher accuracy in detecting the contamination factors associated with the environment and natural rocks. SEM revealed the goodness-of-fit indices 0.993, 0.999, 1.000, and 0.999 in summer, SWM, NEM, and winter, respectively. Hence, this study provides insight view of variation of fluoride concentration in groundwater in different seasons and also mentions the factors that influence fluoride concentration in Vaniyambadi and Ambur taluk.

PMID:37615908 | DOI:10.1007/s11356-023-29254-6

Psychometrika. 2023 Aug 24. doi: 10.1007/s11336-023-09926-5. Online ahead of print.

ABSTRACT

In social, behavioral and economic sciences, researchers are interested in modeling a social network among a group of individuals, along with their attributes. The attributes can be responses to survey questionnaires and are often high dimensional. We propose a joint latent space model (JLSM) that summarizes information from the social network and the multivariate attributes in a person-attribute joint latent space. We develop a variational Bayesian expectation-maximization estimation algorithm to estimate the attribute and person locations in the joint latent space. This methodology allows for effective integration, informative visualization and prediction of social networks and attributes. Using JLSM, we explore the French financial elites based on their social networks and their career, political views and social status. We observe a division in the social circles of the French elites in accordance with the differences in their attributes. We analyze user networks and behaviors in multimodal social media systems like YouTube. A R package “jlsm” is developed to fit the models proposed in this paper and is publicly available from the CRAN repository https://cran.r-project.org/web/packages/jlsm/jlsm.pdf .

PMID:37615903 | DOI:10.1007/s11336-023-09926-5

Ther Innov Regul Sci. 2023 Aug 24. doi: 10.1007/s43441-023-00570-w. Online ahead of print.

ABSTRACT

Master protocols (MPs) are an important addition to the clinical trial repertoire. As defined by the U.S. Food and Drug Administration (FDA), this term means “a protocol designed with multiple sub-studies, which may have different objectives (goals) and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure.” This means we now have a unique, scientifically based MP that describes how a clinical trial will be conducted using one or more potential candidate therapies to treat patients in one or more diseases. Patient engagement (PE) is also a critical factor that has been recognized by FDA through its Patient-Focused Drug Development (PFDD) initiative, and by the European Medicines Agency (EMA), which states on its website that it has been actively interacting with patients since the creation of the Agency in 1995. We propose that utilizing these PE principles in MPs can make them more successful for sponsors, providers, and patients. Potential benefits of MPs for patients awaiting treatment can include treatments that better fit a patient’s needs; availability of more treatments; and faster access to treatments. These make it possible to develop innovative therapies (especially for rare diseases and/or unique subpopulations, e.g., pediatrics), to minimize untoward side effects through careful dose escalation practices and, by sharing a control arm, to lower the probability of being assigned to a placebo arm for clinical trial participants. This paper is authored by select members of the American Statistical Association (ASA)/DahShu Master Protocol Working Group (MPWG) People and Patient Engagement (PE) Subteam. DahShu is a 501(c)(3) non-profit organization, founded to promote research and education in data science. This manuscript does not include direct feedback from US or non-US regulators, though multiple regulatory-related references are cited to confirm our observation that improving patient engagement is supported by regulators. This manuscript represents the authors’ independent perspective on the Master Protocol; it does not represent the official policy or viewpoint of FDA or any other regulatory organization or the views of the authors’ employers. The objective of this manuscript is to provide drug developers, contract research organizations (CROs), third party capital investors, patient advocacy groups (PAGs), and biopharmaceutical executives with a better understanding of how including the patient voice throughout MP development and conduct creates more efficient clinical trials. The PE Subteam also plans to publish a Plain Language Summary (PLS) of this publication for clinical trial participants, patients, caregivers, and the public as they seek to understand the risks and benefits of MP clinical trial participation.

PMID:37615880 | DOI:10.1007/s43441-023-00570-w

Appl Biochem Biotechnol. 2023 Aug 24. doi: 10.1007/s12010-023-04714-4. Online ahead of print.

ABSTRACT

The objective of this study is to investigate the expression of the carbohydrate response element binding protein (ChREBP) gene in type 2 diabetes mellitus (T2DM) and its correlation with pathological features. For obtaining and exploring the pathological features in patients, sixty T2DM patients (the research group) and thirty healthy controls (the control group) presented to our hospital between January 2019 and June 2019 were selected as the research participants. After DNA extraction from peripheral blood mononuclear cells (PBMCs) and modification of target gene methylation with bisulfite, differences in methylation were verified, and the correlation of ChREBP methylation level with T2DM pathological features and single nucleotide polymorphism (SNP) typing was discussed. According to the prediction results of UCSC Genome Browser Home, there were two CpG islands in the promoter region of the ChREBP gene, and the first exon was selected for research. The ChREBP methylation rate was statistically higher in the research group versus the control group (P < 0.05). Age, FPG, TC, and TG were confirmed by the multiple linear regression analysis to be correlated with the ChREBP methylation rate (P < 0.05). Finally, there was no difference in ChREBP methylation level between CT- and CC-type patients at rs17145750 and rs1051921 loci (P > 0.05). Peripheral blood ChREBP methylation is elevated in T2DM patients and is closely related to age, blood glucose, and blood-lipid level, which is expected to be a new direction for future T2DM diagnosis and treatment.

PMID:37615853 | DOI:10.1007/s12010-023-04714-4

Int Urol Nephrol. 2023 Aug 24. doi: 10.1007/s11255-023-03749-0. Online ahead of print.

ABSTRACT

PURPOSE: To assess differences in the length of hospital stay (LOS) in patients who present emergently versus electively for a symptomatic ureteral stone and to explore underlying risk factors.

METHODS: Billing data were analyzed from patients with symptomatic ureteral calculi at our department from 2010 to 2021. Statistical analysis (U test, logistic regression) was performed.

RESULTS: 2274 patients (72% male, 28% female) with ureteral stones were analyzed (mean age of 52.9y). 1578 patients (69.4%) presented in an emergency setting and 696 patients (30.6%) electively. Arterial hypertension was seen in 31%, diabetes mellitus in 11% and hyperuricemia in 5% of the whole cohort. 46.5% of emergency patients were desobstructed (DJ/PCN), 35.4% underwent emergency ureteroscopy (URS), 13.4% had spontaneous passage (SP), and 4.8% underwent emergency shock wave lithotripsy (SWL). Of the electively treated patients, 58.6% underwent URS, 21.3% SWL, 18.5% DJ/PCN, and 1.6% had SP. Emergency stone treatment was associated with a significantly longer LOS when compared to primary desobstruction for patients admitted emergently. Also, LOS was significantly longer for each intervention of stone treatment in emergency patients vs. electively treated patients. Arterial hypertension was associated with a 1.8-fold increased risk of a hospital stay longer than 3 days, irrespective of hospital admission mode, whereas metabolic disorders did not influence LOS in this cohort.

CONCLUSION: For emergency patients in contrast to the electively treated patients, the type of procedure had a significant impact on the length of hospital stay. Arterial hypertension is an independent significant risk factor for prolonged hospital stay.

PMID:37615842 | DOI:10.1007/s11255-023-03749-0

Pharmacogenomics. 2023 Aug 24. doi: 10.2217/pgs-2023-0097. Online ahead of print.

ABSTRACT

Objective & methods: This study tested associations of genotype-predicted activity of CYP3A4, other pharmacogenes and SLC28A7 (rs11648166) and ALPPL2 (rs28845026) with systemic concentrations of the endocrine therapies anastrozole and fulvestrant in SWOG S0226 trial participants. Results: Participants in the anastrozole-only arm with low CYP3A4 activity (i.e., CYP3A4*22 carriers) had higher systemic anastrozole concentrations than patients with high CYP3A4 activity (β-coefficient = 10.03; 95% CI: 1.42, 18.6; p = 0.025). In an exploratory analysis, participants with low CYP2C9 activity had lower anastrozole concentrations and higher fulvestrant concentrations than participants with high CYP2C9 activity. Conclusion: Inherited genetic variation in CYP3A4 and CYP2C9 may affect concentrations of endocrine therapy and may be useful to personalize dosing and improve treatment outcomes.

PMID:37615099 | DOI:10.2217/pgs-2023-0097

Hypertension. 2023 Aug 24. doi: 10.1161/HYPERTENSIONAHA.123.21510. Online ahead of print.

ABSTRACT

BACKGROUND: Multiple office blood pressure (BP) readings correlate more closely with ambulatory BP than single readings. Whether they are associated with long-term outcomes and improve cardiovascular risk prediction is unknown. Our objective was to assess the long-term impact of multiple office BP readings.

METHODS: We used data from CARTaGENE, a population-based survey comprising individuals aged 40 to 70 years. Three BP readings (BP₁, BP₂, and BP₃) at 2-minute intervals were obtained using a semiautomated device. They were averaged to generate BP_1-2, BP_2-3, and BP_1-2-3 for systolic BP (SBP) and diastolic BP. Cardiovascular events (major adverse cardiovascular event [MACE]: cardiovascular death, stroke, and myocardial infarction) during a 10-year follow-up were recorded. Associations with MACE were obtained using adjusted Cox models. Predictive performance was assessed with 10-year atherosclerotic cardiovascular disease scores and their associated C statistics.

RESULTS: In the 17 966 eligible individuals, 2378 experienced a MACE during follow-up. Crude SBP values ranged from 122.5 to 126.5 mm Hg. SBP₃ had the strongest association with MACE incidence (hazard ratio, 1.10 [1.05-1.15] per SD) and SBP₁ the weakest (hazard ratio, 1.06 [1.01-1.10]). All models including SBP₁ (SBP₁, SBP_1-2, and SBP_1-2-3) were underperformed. At a given SBP value, the excess MACE risk conferred by SBP₃ was 2× greater than SBP₁. In atherosclerotic cardiovascular disease scores, SBP₃ yielded the highest C statistic, significantly higher than most other SBP measures. In contrast to SBP, all diastolic BP readings yielded similar results.

CONCLUSIONS: Cardiovascular risk prediction is improved by successive office SBP values, especially when the first reading is discarded. These findings reinforce the necessity of using multiple office BP readings.

PMID:37615094 | DOI:10.1161/HYPERTENSIONAHA.123.21510

Integr Cancer Ther. 2023 Jan-Dec;22:15347354231154267. doi: 10.1177/15347354231154267.

ABSTRACT

A 4-year prospective cohort study on patients with lung, gastric, hepatic, colorectal, breast, uterine, and ovarian cancer was conducted at the East-West Cancer Center (EWCC) of Daejeon Korean Medicine Hospital in Daejeon, Korea. We divided patients into 2 groups based on how long they had been receiving TKM oncotherapy and compared event-free survival (EFS), telomere length change, and quality of life (QoL). The study collected data on 83 patients from October 2016 to June 2020 and discovered no statistical differences in EFS based on the duration of TKM oncotherapy. In the analysis of changes in QoL outcomes, there were no statistically significant group differences between the groups. After controlling for covariates that could affect telomere length, the long-term TKM oncotherapy group had a higher daily telomere attrition rate. The study of the relationship between telomere length and prognostic factors discovered that patients with advanced N stage at the time of diagnosis and who had previously received radiotherapy had shorter telomere length. When examining associations between SNP genotype and percentile score of telomere length, this study was able to confirm an association between telomere length and rs4387287. This study is significant because it is the first to assess the effects of TKM oncotherapy and investigate telomere length-related factors. To assess the effects of TKM oncotherapy on cancer patients’ survival and QoL, a longer-term observational study with a larger sample size is required.

PMID:37615075 | DOI:10.1177/15347354231154267

Pediatrics. 2023 Aug 24:e2023062285. doi: 10.1542/peds.2023-062285. Online ahead of print.

NO ABSTRACT

PMID:37615069 | DOI:10.1542/peds.2023-062285

Front Plant Sci. 2023 Aug 8;14:1213250. doi: 10.3389/fpls.2023.1213250. eCollection 2023.

ABSTRACT

A large English population of the temperate tuberous Greater Butterfly-orchid, Platanthera chlorantha, was monitored through a 16-year period. Each June the number of flowering plants was counted and 60 flowering plants were measured in situ for four morphological traits, selected for both ease of measurement and their contrasting contributions to the life history of the species. Trait data were tested annually in pairwise combinations for individual plants, before mean values throughout the study period were regressed and cross-correlated against each other and against local data for four meteorological parameters. Labellar spur length proved to be more constrained than either flower number or stem height, and rarely yielded statistically significant correlations with other traits, whereas the three remaining traits reliably showed modest but significant correlations. Mean values and coefficients of variation differed only modestly among years and showed few of any meaningful trends. Spring rainfall and insolation had no detectable effect on traits of plants flowering that June; instead, they impacted on trait expression during the following year, presumably as a result of differential resourcing of replacement tubers formed during the previous year. High spring rainfall in year t-1 increased leaf area and stem height in year t, whereas the widely fluctuating number of flowering plants was highest in years immediately following those characterised by relatively dry and/or sunny springs. The “decision” to flower is taken during the previous summer, though it may be modified through winter/spring abortion of above-ground organs. The proportion of the population electing to flower is the only measured parameter that impacts significantly on annual reproductive output, emphasising the under-rated difficulty of evolving through directional selection. Any attempt to predict the behaviour of plant species in response to climate change must integrate information on demography with that on life history, habitat preference and intimate symbioses.

PMID:37615028 | PMC:PMC10442717 | DOI:10.3389/fpls.2023.1213250