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Nevin Manimala Statistics

Comparative analysis of the effects of dalteparin and reviparin on perioperative blood loss in patients with extracapsular hip fractures treated with intramedullary nailing

Med Glas (Zenica). 2023 Feb 1;20(1). doi: 10.17392/1526-22. Online ahead of print.

ABSTRACT

Aim To determine differences between reviparin and dalteparin treatment in patients with extracapsular hip fractures treated with intramedullary nailing and their effects on perioperative blood loss and early postoperative recovery. Methods Retrospective comparative study included 68 patients with extracapsular hip fracture who were divided into dalteparin and reviparin group. Medical records were used to obtain demographic data, laboratory parameters, haemoglobin and haematocrit levels, platelet count, mortality rate and medical complications. Results Out of total 68 patients, 31 were in reviparin and 37 in dalteparin group. Mean age of patients was 70.5 (±14.4) and 76.8 (±8.4) years in reviparin and dalteparin group, respectively (p=0.071). Median values of haemoglobin levels on the first postoperative day were lower in dalteparin group compared to reviparin group (p=0.012). On the first postoperative day haematocrit values were also lower in dalteparin than in reviparin group (p=0.015). Both groups showed an increase in platelet count on the first postoperative day, but without significant difference (p=0.084). There was no statistically significant difference in intrahospital mortality between the groups (6.4% vs. 2.7%; p=0.588). One case of pulmonary embolism was detected in the dalteparin group. Conclusion Low-molecular-weight heparin is the drug of choice in patients with hip fractures for thromboprophylaxis. Due to non-antithrombin-mediated actions, reviparin and dalteparin could have different effects on perioperative blood loss. Both dalteparin and reviparin are safe and effective agents for thromboprophylaxis in patients with proximal femur fractures.

PMID:36435999 | DOI:10.17392/1526-22

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Parameters in predicting the risk of a prolonged hospital stay in patients with acute exacerbation of chronic obstructive pulmonary disease: a single-centre experience

Med Glas (Zenica). 2023 Feb 1;20(1). doi: 10.17392/1514-22. Online ahead of print.

ABSTRACT

Aim To identify clinical and laboratory parameters on admission and/or during a hospital stay that would predict prolonged hospital stay in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods A retrospective cross-sectional study was conducted at the Clinic for Pulmonary Diseases and Tuberculosis, Clinical Centre University of Sarajevo for the period 2019-2021 accounting patients admitted due to AECOPD. The need for hospitalization was evaluated according to the current GOLD criteria and certain clinical parameters. Spirometry testing and laboratory analysis were performed for all patients on the day of admission and on the 10th day of hospital stay. Linear regression was used to show the relationship between multiple independent predictor variables and LOS. Results A total of 50 patients were evaluated during their hospital stay due to AECOPD. Median of LOS was 22.02±1.06, with 90% hospital survival rate. Due to AECOPD the median of LOS in the intensive care unit (ICU) was 4±0.68 days with pH<7.35 in 34% of hospitalized patients. According to spirometry classification on the day of admission, 56% of patients were assigned to group 3 and 16% to group 4 with significant improvement identified on spirometry findings on discharge. Platelets on the day of admission were the only statistically significant positive predictors of the length of hospital stay. Conclusion Identifying chronic obstructive pulmonary disease patients at risk of frequent exacerbations and appropriate disease management could reduce the disease burden.

PMID:36435996 | DOI:10.17392/1514-22

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Early introduction of peanut reduces peanut allergy across risk groups in pooled and causal inference analyses

Allergy. 2022 Nov 27. doi: 10.1111/all.15597. Online ahead of print.

ABSTRACT

BACKGROUND: The LEAP study has shown the effectiveness of early peanut introduction in prevention of peanut allergy (PA). In the EAT study, a statistically significant reduction in PA was present only in per-protocol (PP) analyses, which can be subject to bias.

OBJECTIVE: To combine individual-level data from the LEAP and EAT trials and provide robust evidence on the bias-corrected, causal effect of early peanut introduction.

METHOD: As part of the European Union-funded iFAAM project, this pooled analysis of individual paediatric patient data combines and compares effectiveness and efficacy estimates of oral tolerance induction among different risk strata and analysis methods.

RESULTS: An intention-to-treat (ITT) analysis of pooled data showed a 75% reduction in PA (p<0.0001) among children randomized to consume peanut from early infancy. A protective effect was present across all eczema severity groups, irrespective of enrolment sensitization to peanut, and across different ethnicities. Earlier age of introduction was associated with improved effectiveness of the intervention. In the pooled PP analysis, peanut consumption reduced the risk of PA by 98% (p<0.0001). A causal inference analysis confirmed the strong PP effect (89% average treatment effect relative risk reduction p<0.0001). A multivariable causal inference analysis approach estimated a large (100%) reduction in PA in children without eczema (p=0.004).

CONCLUSION: We demonstrate a significant reduction in PA with early peanut introduction in a large group of pooled, randomized participants. This significant reduction was demonstrated across all risk subgroups, including children with no eczema. Furthermore, our results point to increased efficacy of the intervention with earlier age of introduction.

PMID:36435990 | DOI:10.1111/all.15597

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Association of lipid accumulation products with testosterone deficiency in adult American men: A cross-sectional study

Andrology. 2022 Nov 27. doi: 10.1111/andr.13355. Online ahead of print.

ABSTRACT

PURPOSE: Testosterone deficiency and changes in testosterone levels are important in men’s health and may be associated with fat accumulation. In order to investigate the connection between testosterone and fat accumulation in adult males, we employed lipid accumulation product (LAP) and compared it to TyG and HOMA-IR.

MATERIALS AND METHODS: A intersecting surface research of participators from 2013-2014was carried out using NHANES, in addition, participants from 2015 to 2016 were selected. Using multivariate adjusted logistic regression, the connection between LAP, testosterone levels, and testosterone insufficiency was investigated, smoothed curve fitting to integrate non-linear relationships, and subgroup analysis to identify sensitive populations.

RESULTS: After removing all potential confounders, testosterone levels in 1651 subjects tended to decrease with increasing continuous variable LAP (β = -0.49, 95% CI [-0.77, -0.22], p = 0.0005) and adding the chance of testosterone deficiency (OR = 1.01, 95% CI [1.01,1.01], p < 0.0001). In the LAP quartile, testosterone levels decreased the most (β = -77.65, 95% CI [-110.99, -44.31], p <0.0001) and the risk of testosterone deficiency was highest (OR = 2.76, 95% CI [1.47, 5.20], p = 0.0016). The AUC values were 0.718(95% CI: 0.688-0.750) for LAP, 0.723 (95% CI: 0.689-0.756) for HOMA-IR, and 0.673(95% CI: 0.640-0.708) for TyG, with no statistical difference between LAP and HOMA-IR comparisons. The cut-off value of LAP ≥ 52.408 predicted testosterone deficiency with good sensitivity and specificity.

CONCLUSION: Higher LAP was linked to a higher incidence of testosterone loss and inadequate, especially in hypertensive and nonsmoker. LAP is a better predictor of testosterone deficiency than TyG and does not differ significantly from the HOMA-IR phase. This article is protected by copyright. All rights reserved.

PMID:36435978 | DOI:10.1111/andr.13355

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Design Considerations for Two Stage Enrichment Clinical Trials

Biometrics. 2022 Nov 27. doi: 10.1111/biom.13805. Online ahead of print.

ABSTRACT

When there is a predictive biomarker, enrichment can focus the clinical trial on a benefiting subpopulation. We describe a two-stage enrichment design, in which the first stage is designed to efficiently estimate a threshold and the second stage is a “phase III-like” trial on the enriched population. The goal of this paper is to explore design issues: sample size in stages 1 and 2, and re-estimation of the stage 2 sample size following stage 1. By treating these as separate trials, we can gain insight into how the predictive nature of the biomarker specifically impacts the sample size. We also show that failure to adequately estimate the threshold can have disastrous consequences in the second stage. While any bivariate model could be used, we assume a continuous outcome and continuous biomarker, described by a bivariate normal model. The correlation coefficient between the outcome and biomarker is the key to understanding the behavior of the design, both for predictive and prognostic biomarkers. Through a series of simulations we illustrate the impact of model misspecification, consequences of poor threshold estimation, and requisite sample sizes that depend on the predictive nature of the biomarker. Such insight should be helpful in understanding and designing enrichment trials. This article is protected by copyright. All rights reserved.

PMID:36435977 | DOI:10.1111/biom.13805

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Theoretical insight into the acidity and cooperativity effect of the LLM-105∙(HNO3)2 system

J Mol Model. 2022 Nov 26;28(12):401. doi: 10.1007/s00894-022-05376-5.

ABSTRACT

In order to reveal the nature of the acidity in explosive product, the acidities and cooperativity effects from the intermolecular H-bonding interactions in the LLM-105∙∙∙(HNO3)2 ternary systems were investigated at the B3LYP/6-311 + + G** and M062X/6-311 + + G** levels, with the integral equation formalism polarized continuum model (IEFPCM) based on the self-consistent-reaction-field. The results show that for the ternary systems, the intermolecular H-bonding interactions are stronger than those in the binary complexes, resulting in the lower [H+] concentrations and larger pKa1 values upon the ternary-complex formations. However, there is no obvious correlation between the acidities and cooperativity effects or APT charges of the H atoms involving the H-bonds. Surface electrostatic potential (ESP) and reduced density gradient are used to reveal the nature of the H-bond and acidity. Interestingly, the acidity is closely related to the ESPs of the H atom (VS,H) involving the intermolecular H-bond, but not to the statistical quantities. This is mainly because both acidity and VS,H are the local properties of system, whereas the cooperativity and statistical quantity of ESP are the global property.

PMID:36435941 | DOI:10.1007/s00894-022-05376-5

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The chemical landscape of high-throughput new approach methodologies for exposure

J Expo Sci Environ Epidemiol. 2022 Nov 26. doi: 10.1038/s41370-022-00496-9. Online ahead of print.

ABSTRACT

The rapid characterization of risk to humans and ecosystems from exogenous chemicals requires information on both hazard and exposure. The U.S. Environmental Protection Agency’s ToxCast program and the interagency Tox21 initiative have screened thousands of chemicals in various high-throughput (HT) assay systems for in vitro bioactivity. EPA’s ExpoCast program is developing complementary HT methods for characterizing the human and ecological exposures necessary to interpret HT hazard data in a real-world risk context. These new approach methodologies (NAMs) for exposure include computational and analytical tools for characterizing multiple components of the complex pathways chemicals take from their source to human and ecological receptors. Here, we analyze the landscape of exposure NAMs developed in ExpoCast in the context of various chemical lists of scientific and regulatory interest, including the ToxCast and Tox21 libraries and the Toxic Substances Control Act (TSCA) inventory. We examine the landscape of traditional and exposure NAM data covering chemical use, emission, environmental fate, toxicokinetics, and ultimately external and internal exposure. We consider new chemical descriptors, machine learning models that draw inferences from existing data, high-throughput exposure models, statistical frameworks that integrate multiple model predictions, and non-targeted analytical screening methods that generate new HT monitoring information. We demonstrate that exposure NAMs drastically improve the coverage of the chemical landscape compared to traditional approaches and recommend a set of research activities to further expand the development of HT exposure data for application to risk characterization. Continuing to develop exposure NAMs to fill priority data gaps identified here will improve the availability and defensibility of risk-based metrics for use in chemical prioritization and screening. IMPACT: This analysis describes the current state of exposure assessment-based new approach methodologies across varied chemical landscapes and provides recommendations for filling key data gaps.

PMID:36435938 | DOI:10.1038/s41370-022-00496-9

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Nevin Manimala Statistics

Sutureless versus conventional deep sclerectomy for management of open angle glaucoma

Graefes Arch Clin Exp Ophthalmol. 2022 Nov 26. doi: 10.1007/s00417-022-05910-4. Online ahead of print.

ABSTRACT

INTRODUCTION: To compare sutureless deep sclerectomy to conventional deep sclerectomy regarding their lowering effect on intraocular pressure (IOP) in cases with open-angle glaucoma.

METHODS: This is a prospective interventional randomized comparative study that included 60 eyes of 50 patients with open-angle glaucoma (OAG) who were indicated for surgical intervention. Patients were recruited from the glaucoma subspecialty clinic of the Cairo University teaching hospital and were divided into two groups: group A (underwent sutureless deep sclerectomy) and group B (underwent conventional deep sclerectomy).

RESULTS: Both surgeries showed significant reduction of IOP all through the study period: in group A, mean reduction was 71.37%, 53.35%, 50.3%, and 44.33% at 1st day, 1 month, 3 months, and 6 months respectively, and in group B, mean reduction was 57.62%, 40.63%, 37.41%, and 31.68% at 1st day, 1 month, 3 months, and 6 months, respectively. Comparison between percentage of reduction in both groups showed no statistically significant difference. Also, use of anti-glaucoma medications dropped significantly at 6 months postoperatively in both groups with no significant difference between the 2 groups. Regarding reported complications, 12.9% in group A and 10.3% in group B presented with non-serious complications. One month postoperatively, UBM detected non-functioning blebs in 6.4% of group A and 3.4% in group B. Other cases with non-functioning blebs were detected at 3 and 6 months postoperatively, and all cases were managed.

CONCLUSION: Sutureless deep sclerectomy seems to be a safe and effective modification, with significant IOP reduction in POAG.

PMID:36435917 | DOI:10.1007/s00417-022-05910-4

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Mortality following proximal humerus fracture-a nationwide register study of 147,692 fracture patients in Sweden

Osteoporos Int. 2022 Nov 26. doi: 10.1007/s00198-022-06612-7. Online ahead of print.

ABSTRACT

Little is known about survival after proximal humerus fracture. In this manuscript, we found the mortality to be high (almost four times higher than in age- and sex-matched controls). While frailty hip fracture has gained attention, we hope our manuscript will shed light on frailty proximal humerus fracture patients.

INTRODUCTION: Proximal humerus fractures (PHF) are common and occur mostly after the 6th decade of life. While mortality following PHF has been reported previously, mortality data after longer follow-up on a national level is lacking.

METHODS: We obtained data from the Swedish Hospital Discharge Register (SHDR), on all adult patients (≥ 18 years) with a diagnosis of PHF (S42.2, S42.20, or S42.21) for the period between 2001 and 2016. We used the Swedish Cause of Death Register (SCDR) to investigate mortality in the fracture cohort. We compared the mortality of fracture patients with age- and sex-matched population-based mortality data obtained from Statistics Sweden.

RESULTS: A total of 147 692 PHF patients were identified, with a male to female ratio of 1:3. The mean age was 69 years (range, 18 to 111). Most patients were treated non-surgically (n = 126,487, 86%). The crude mortality rate was 2.2% at 1 month, 4.1% at 3 months, 8.5% at 12 months, and 24% at 48 months after sustaining a PHF. Mortality increased with age; however, the standardized mortality rate (SMR) was highest among young patients. SMR was 5.4 in the 18- to 39-year age group, 3.9 in the 40- to 64-year age group, 1.8 in the 65-79-year age group, and 1.2 in the ≥ 80-year-old population. The age-adjusted SMR was 3.9 in the whole adult PHF population.

CONCLUSION: The mortality rate and SMR suggest that PHF patients are heterogeneous. Some older PHF patients may benefit from specialized care (e.g., orthogeriatric), and this should be evaluated in future studies.

PMID:36435907 | DOI:10.1007/s00198-022-06612-7

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Maternal and neonatal exposure to risk factors for neonates with moderate or severe hypoxic ischemic encephalopathy: a cross-sectional study

Ital J Pediatr. 2022 Nov 26;48(1):188. doi: 10.1186/s13052-022-01380-w.

ABSTRACT

BACKGROUND: To investigate the association between maternal and neonatal exposure to the relevant influencing factors and risk of moderate or severe hypoxic ischemic encephalopathy (HIE), and the possible interactions in the Chinese population.

METHODS: A cross-sectional study comprising 228 neonates from Henan Children’s Hospital during the five-year period 2015-2020 in China was conducted. All neonatal basic demographic information and clinical records were documented from the neonatal HIE database. Comparisons between mild HIE and moderate or severe HIE were conducted with the t-test or Wilcoxon rank-sum test for continuous variables and the Chi-square test for categorical variables. Unconditional multiple logistic regression models were used to generate the odds ratios(ORs) and 95% confidence intervals(CIs). In addition, we also used an additive model to test for possible biological interactions among the factors.

RESULTS: Of the 228 neonates, the males had a statistically significantly higher frequency compared with the females between the two groups (P = 0.030). Trend analysis results found that with the decreased of the neonatal birth weight, the detection rates of moderate or severe HIE in males and females were gradually increased (Ptrend < 0.05). The detection of moderate or severe HIE in males and females increased with the decreased of neonatal gestational age at birth(Ptrend < 0.05). However, no interaction was detected between neonatal birth weight and gestational age at birth based on the additive model, the Relative Excess Risk of Interaction and 95% CI was 0.821(-0.046,1.687). The adjusted multiple logistic regression model showed that low birth weight(ORadj:1.965, 95%CI:1.086-4.127),premature infant(ORadj:1.557, 95%CI:1.589-4.862),1-min Apgar’s score < 7(ORadj:5.618, 95%CI:3.724-7.353),intrauterine distress(ORadj:4.916, 95%CI:3.431-7.398),amniotic fluid contamination (ORadj:3.965, 95%CI:2.153-5.782) significantly increased the risk of neonatal moderate or severe HIE.

CONCLUSION: Neonates with low birth weight, premature infant,1-min Apgar’s score < 7, intrauterine distress, amniotic fluid contamination are risk factors for moderate or severe HIE. Notably, we found no biological interaction between risk factors based on the additive model, these findings may help to inform prevention strategies, as this may effectively reduce the incidence of neonatal moderate or severe HIE.

PMID:36435902 | DOI:10.1186/s13052-022-01380-w