Tag: statistics

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

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

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 pK_a1 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 (V_S,H) involving the intermolecular H-bond, but not to the statistical quantities. This is mainly because both acidity and V_S,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

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

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

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

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 (P_trend < 0.05). The detection of moderate or severe HIE in males and females increased with the decreased of neonatal gestational age at birth(P_trend < 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(OR_adj:1.965, 95%CI:1.086-4.127),premature infant(OR_adj:1.557, 95%CI:1.589-4.862),1-min Apgar’s score < 7(OR_adj:5.618, 95%CI:3.724-7.353),intrauterine distress(OR_adj:4.916, 95%CI:3.431-7.398),amniotic fluid contamination (OR_adj: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

Clin Exp Metastasis. 2022 Nov 26. doi: 10.1007/s10585-022-10195-2. Online ahead of print.

ABSTRACT

PURPOSE: The effect of preoperative embolization of bone metastases prior to stabilization procedures in reducing intraoperative blood loss remains controversial. This study aimed to analyze the effect of preoperative embolization on orthopedic stabilization procedures of the extremities and spine in cases with bone metastases from renal cell carcinomas. In particular, do these patients suffer less blood loss during the operation and do they need lesser fluid replacements or packed red cell bags intra- and perioperatively? Does preoperative embolization reduce the duration of surgery?

METHODS: We retrospectively reviewed stabilization procedures of the spine and extremities at our institution between 2011 and 2021 for group differences (embolization vs. no embolization) in terms of blood loss, fluid substitution, need for packed red cell transfusions, tumor size, and duration of surgery.

RESULTS: We reviewed 79 stabilization procedures of the spine (n = 36) and extremities (n = 43), of which 30 included preoperative embolization procedures. Surprisingly, the embolization group showed a statistically significant increase in blood loss, the need for fluid substitution, and red cell transfusions. Subgroup analysis revealed a significant negative effect of preoperative embolization on stabilization procedures of the extremities.

CONCLUSION: Based on our data, preoperative embolization of renal cell carcinoma metastases of the extremities had a negative effect on intraoperative blood loss and the need for fluid substitution and should therefore be avoided. Our data did not show an effect on stabilization procedures of the spine.

PMID:36435893 | DOI:10.1007/s10585-022-10195-2

Insights Imaging. 2022 Nov 26;13(1):182. doi: 10.1186/s13244-022-01308-2.

ABSTRACT

OBJECTIVES: To evaluate image quality and diagnostic performance of carotid dual-energy computed tomography angiography (DECTA) using deep learning image reconstruction (DLIR) compared with images using adaptive statistical iterative reconstruction-Veo (ASIR-V).

METHODS: Carotid DECTA datasets of 28 consecutive patients were reconstructed at 50 keV using DLIR at low, medium, and high levels (DLIR-L, DLIR-M, and DLIR-H) and 80% ASIR-V algorithms. Mean attenuation, image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) at different levels of arteries were measured and calculated. Image quality for noise and texture, depiction of arteries, and diagnostic performance toward carotid plaques were assessed subjectively by two radiologists. Quantitative and qualitative parameters were compared between the ASIR-V, DLIR-L, DLIR-M, and DLIR-H groups.

RESULTS: The image noise at aorta and common carotid artery, SNR, and CNR at all level arteries of DLIR-H images were significantly higher than those of ASIR-V images (p = 0.000-0.040). The quantitative analysis of DLIR-L and DLIR-M showed comparable denoise capability with ASIR-V. The overall image quality (p = 0.000) and image noise (p = 0.000-0.014) were significantly better in the DLIR-M and DLIR-H images. The image texture was improved by DLR at all level compared to ASIR-V images (p = 0.000-0.008). Depictions of head and neck arteries and diagnostic performance were comparable between four groups (p > 0.05).

CONCLUSIONS: Compared with 80% ASIR-V, we recommend DLIR-H for clinical carotid DECTA reconstruction, which can significantly improve the image quality of carotid DECTA at 50 keV but maintain a desirable diagnostic performance and arterial depiction.

PMID:36435892 | DOI:10.1186/s13244-022-01308-2

Trials. 2022 Nov 26;23(1):958. doi: 10.1186/s13063-022-06872-y.

ABSTRACT

BACKGROUND: Randomised controlled trials of non-pharmacological interventions in children’s therapy are rare. This is, in part, due to the challenges of the acceptability of common trial designs to therapists and service users. This study investigated the acceptability of participation in cluster randomised controlled trials to therapists and service users.

METHODS: A national electronic survey of UK occupational therapists, physiotherapists, speech and language therapists, service managers, and parents of children who use their services. Participants were recruited by NHS Trusts sharing a link to an online questionnaire with children’s therapists in their Trust and with parents via Trust social media channels. National professional and parent networks also recruited to the survey. We aimed for a sample size of 325 therapists, 30 service managers, and 60 parents. Trial participation was operationalised as three behaviours undertaken by both therapists and parents: agreeing to take part in a trial, discussing a trial, and sharing information with a research team. Acceptability of the behaviours was measured using an online questionnaire based on the Theoretical Framework of Acceptability constructs: affective attitude, self-efficacy, and burden. The general acceptability of trials was measured using the acceptability constructs of intervention coherence and perceived effectiveness. Data were collected from June to September 2020. Numerical data were analysed using descriptive statistics and textual data by descriptive summary.

RESULTS: A total of 345 survey responses were recorded. Following exclusions, 249 therapists and 40 parents provided data which was 69.6% (289/415) of the target sample size. It was not possible to track the number of people invited to take the survey nor those who viewed, but did not complete, the online questionnaire for calculation of response rates. A completion rate (participants who completed the last page of the survey divided by the participants who completed the first, mandatory, page of the survey) of 42.9% was achieved. Of the three specified trial behaviours, 140/249 (56.2%) therapists were least confident about agreeing to take part in a trial. Therapists (135/249, 52.6%) reported some confidence they could discuss a trial with a parent and child at an appointment. One hundred twenty of 249 (48.2%) therapists reported confidence in sharing information with a research team through questionnaires and interviews or sharing routine health data. Therapists (140/249, 56.2%) felt that taking part in the trial would take a lot of effort and resources. Support and resources, confidence with intervention allocation, and sense of control and professional autonomy over clinical practice were factors that positively affected the acceptability of trials. Of the 40 parents, twelve provided complete data. Most parents (18/40, 45%) agreed that it was clear how trials improve children’s therapies and outcomes and that a cluster randomised trial made sense to them in their therapy situation (12/29, 30%).

CONCLUSIONS: Using trials to evaluate therapy interventions is, in principle, acceptable to therapists, but their willingness to participate in trials is variable. The willingness to participate may be particularly influenced by their views related to the burden associated with trials, intervention allocation, and professional autonomy.

PMID:36435825 | DOI:10.1186/s13063-022-06872-y