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Nevin Manimala Statistics

Zero-Inflated Binomial Model for Meta-Analysis and Safety-Signal Detection

Ther Innov Regul Sci. 2022 Jan 22. doi: 10.1007/s43441-021-00353-1. Online ahead of print.

ABSTRACT

BACKGROUND: Meta-analysis of related trials can provide an overall measure of safety-signal accounting for variability across studies. In addition to an overall measure, researchers may often be interested in study-specific measures to assess safety of the product. Likelihood ratio tests (LRT) methods serve this purpose by identifying studies that appear to show a safety concern. In this paper, we present a Bayesian approach. Despite having good statistical properties, the LRT methods may not be suitable for the meta-analysis of randomized controlled trials (RCTs) when there are several studies with zero events in at least one arm.

METHODS: In this article, we describe a Bayesian framework using a Zero-inflated binomial model with spike-and-slab parameterization for the treatment effects. In addition to providing an overall meta-analytic estimate, this method provides posterior probability of a safety-signal for each study.

RESULTS: We illustrate the approach using two published data sets comprising several randomized controlled trials (RCTs) each and compare the model performance for different choices of priors for treatment effect.

DISCUSSION: The proposed Bayesian methodological framework is useful to identify potential signal for single adverse event and to determine overall meta-analytic estimate of the magnitude of the signal. Practitioners may consider this approach as an alternative to the frequentist’s LRT approach discussed in Jung et al. (J Biopharm Stat 31:47-54, 2020) when there are zero events in either the treatment arm or the control arm. In the future, this approach can be further extended to accommodate multiple adverse events.

PMID:35064554 | DOI:10.1007/s43441-021-00353-1

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Nevin Manimala Statistics

Effect of Cliothosa aurivilli on Paclitaxel-induced Peripheral Neuropathy in Experimental Animals

Mol Neurobiol. 2022 Jan 22. doi: 10.1007/s12035-021-02685-3. Online ahead of print.

ABSTRACT

Chemotherapy-induced peripheral neuropathy (CIPN) is a serious complication leading to painful episodes of parasthesia and numbness in hands and feet. The present drugs that have been used for symptomatic treatment yield inconclusive results in trials and assorted side effects. Thus, there is a pressing demand for development of therapeutically efficacious strategy to combat CIPN. The present study investigates about the effect of a marine sponge; Cliothosa aurivilli (CA) on paclitaxel (PT)-induced peripheral neuropathy in mice. Peripheral neuropathy was induced by intoxication with chemotherapeutic drug PT (2 mg/kg; i.p.) for 5 days consequently. Subsequent treatment with aqueous extract of CA (100 and 200 mg/kg) and standard drug methylcobalamin (MCA) (5 mg/kg) was done and results compared statistically. Neuropathic pain sensations were assessed using various behavioural and locomotory models and evaluated on 0th, 7th and 14th days. Kinovea software was used for video path-tracking of animals and total distance travelled calculated. The results indicated clear signs of improvement post 10 days of PT intoxication in CA-treated groups when compared PT challenged group. A significant reduction in pain behaviours in mechanical allodynia, cold chemical allodynia and thermal hyperalgesia models, improvement in sensory motor coordination, locomotor activity, and distance travelled in closed field model reveals that CA possesses potential ameliorating effect against PT-induced neuropathic pain symptoms. The extract notably improved the movement of the PT challenged animals which was shown by the video path-tracking software and total distance travelled by those animals.

PMID:35064539 | DOI:10.1007/s12035-021-02685-3

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Nevin Manimala Statistics

Application of Parametric Shared Frailty Models to Analyze Time-to-Death of Gastric Cancer Patients

J Gastrointest Cancer. 2022 Jan 22. doi: 10.1007/s12029-021-00775-y. Online ahead of print.

ABSTRACT

BACKGROUND: Despite its declining incidence, gastric cancer (GC) is one of the world’s leading malignancies and a major global health concern due to its high prevalence and fatality rate. Furthermore, it is the world’s fourth most common cancer and the second leading cause of cancer death. Studying the determinants of time to death of gastric cancer patients will give clinicians more information to develop specific treatment plans, forecast prognosis, and track the progress of death cases. The application of the frailty model can help account for random variation in survival that may exist due to unobserved factors, as well as show the impact of latent factors on death risk. As a result, the purpose of this study was to assess the determinants of time to death of GC patients’ by applying the parametric shared frailty models.

METHODS: The data for this study were obtained from gastric cancer patients admitted to the Tikur Anbesa Specialized Hospital, Addis Ababa, from January 1, 2015, to February 29, 2020. With the aim of coming up with an appropriate survival model that determines factors that affect the time to death of gastric cancer patients, various parametric shared frailty models were compared. In all of the frailty models, patient regions were used as a clustering variable. The current study implemented exponential, Weibull, log-logistic, and lognormal distributions for baseline hazard functions with gamma and inverse Gaussian’s frailty distributions. The performance of all models was compared using the AIC and BIC criteria. R statistical software was used to conduct the analysis.

RESULTS: A retrospective study was undertaken on a total of 407 gastric cancer patients under follow-up at Tikur Anbesa Specialized Hospital. Of all 407 GC patients, 56.3% died while the remaining 43.7% were censored. The patients’ median time to death was 21.9 months, with a maximum survival time of 49.6 months. In the current study, the clustering effect was significant in modeling the time to death from gastric cancer. The Weibull model with inverse Gaussian frailty has the minimum AIC and BIC value among the candidate models compared. The dependency within the clusters for the Weibull-inverse Gaussian frailty model was [Formula: see text] (13.4%). According to the results of our best model (Weibull-inverse Gaussian), the sex of the patient, the smoking status, the tumor size, the treatment taken, the vascular invasion, and the disease stage was found to be statistically significant at an alpha = 0.05 significance level.

CONCLUSION: Time to death of GC patient’s data set was well described by the Weibull-inverse Gaussian shared frailty. Furthermore, Weibull baseline distribution best fits the GC data set as it enables proportional hazard and accelerated failure time model, for time to failure data. There is unobserved heterogeneity between clusters (patient regions), indicating the need to account for this clustering effect. In this study, survival time to death among GC patients was discovered to be small. Covariates like older age, being male, having higher (advanced) stage of GC disease (stage three and stage four), advanced tumor size, being smoker, infected by Helicobacter pylori, and existence of vascular invasion significantly accelerate the time to death of GC patients. In contrast, talking combination of more treatments prolongs the time to death of patients. To improve the health of patients, interventions should be taken based on significant prognostic factors, with special attention dedicated to patients with such factors to prevent GC death.

PMID:35064523 | DOI:10.1007/s12029-021-00775-y

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Nevin Manimala Statistics

A systematic review of magnetic versus conventional ureteric stents for short term ureteric stenting

Ir J Med Sci. 2022 Jan 22. doi: 10.1007/s11845-022-02920-3. Online ahead of print.

ABSTRACT

Ureteric stents play an essential role in urology. However, patients can suffer a range of stent-related symptoms with stent in situ and during removal. Conventional ureteric stents are removed using a flexible cystoscopy, whereas magnetic stents may be rapidly removed with a smaller catheter-like retrieval device. The primary aim of this systematic review was to compare the morbidity including pain associated with conventional versus magnetic ureteric stents. The secondary aim was cost comparison. Searches were performed across databases, including Medline, Scopus, Embase and Cochrane. This review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The search from the 5 databases returned a total of 358 articles. After duplicates were removed as well as the inclusion and exclusion criteria applied, a total of 6 studies were included in the final review. Ureteric Stent Symptoms Questionnaire (USSQ) and Visual Analogue Score (VAS) were used in most of the studies. All the studies reported that magnetic ureteric stents resulted in a reduction in the pain on the removal of magnetic ureteric stents, and no statistically significant difference with indwelling ureteric stents. Furthermore, majority of the studies reported a reduction in the cost associated with magnetic ureteric stents. There is no significant difference in pain from indwelling ureteric stents. There is a reduction in pain with the removal of magnetic ureteric stents compared to conventional removal via cystoscopy and an associated reduction in cost.

PMID:35064536 | DOI:10.1007/s11845-022-02920-3

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Nevin Manimala Statistics

Experimental study on the pore and solid structures of municipal solid waste under compression based on computed tomography (CT) scans

Environ Sci Pollut Res Int. 2022 Jan 21. doi: 10.1007/s11356-022-18696-z. Online ahead of print.

ABSTRACT

Municipal solid waste (MSW) is a highly heterogeneous porous medium that contains a variety of components and has complex pores and solid structures. Macroscale experiments are insufficient to describe the hydraulic and mechanical properties of MSW, especially for preferential flow in pores and the reinforcing effect of solids. For a deep understanding of the microscale structure of MSW, CT scanning tests were carried out on two kinds of samples prepared in the laboratory and drilled in landfills. MSW images were divided into pores and solids through dynamic threshold segmentation and morphological denoising methods. The distributions of pore size and structural solid angle were calculated by the maximum inscribed sphere (MIS) algorithm and angle statistical algorithm based on the surface model, respectively. According to the pore-size distribution, the pores were divided into large (diameter > 1 mm), medium (1 mm > diameter > 0.1 mm), and small (diameter < 0.1 mm) pores in MSW. Under a vertical stress of 50 kPa, the porosities of the large, medium, and small pores were 35%, 12%, and 26%, respectively. As the vertical stress increased to 400 kPa, the porosity of large pores decreased significantly to 15%, while the porosities of medium and small pores remained almost unchanged. In addition, the structural solid angle tended to be horizontal under compression, but its influence was limited. The structural solid angle was mainly concentrated at approximately 30-32°. The probability distribution of the structural solid angle could be well fitted using the Gauss function.

PMID:35064512 | DOI:10.1007/s11356-022-18696-z

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Nevin Manimala Statistics

Comparison of Demographic and Clinical Features of Bipolar Disorder in Persons of African and European Ancestry

J Racial Ethn Health Disparities. 2022 Jan 21. doi: 10.1007/s40615-022-01228-3. Online ahead of print.

ABSTRACT

AIM: This study quantified and compared demographic and clinical features of bipolar disorder (BD) in persons of African ancestry (AA) and European ancestry (EUR).

METHODS: Participants enrolled in the Mayo Clinic Bipolar Biobank from 2009 to 2015. The structured clinical interview for DSM-IV was used to confirm the diagnosis of BD, and a questionnaire was developed to collect data on the clinical course of illness. Descriptive statistics and bivariate analyses were completed to compare AA versus EUR participants. Subsequently, clinical outcomes were compared between AA and EUR participants using linear regression for continuous outcomes or logistic regression for binary outcomes while controlling for differences in age, sex, and recruitment site.

RESULTS: Of 1865 participants enrolled in the bipolar biobank, 65 (3.5%) self-identified as AA. The clinical phenotype for AA participants, in comparison to EUR participants, was more likely to include a history of PTSD (39.7% vs. 26.2%), cocaine use disorder (24.2% vs. 11.9%), and tardive dyskinesia (7.1% vs. 3%).

CONCLUSION: The low rate of AA enrollment is consistent with other genetic studies. While clinical features of bipolar disorder are largely similar, this study identified differences in rates of trauma, substance use, and tardive dyskinesia that may represent health disparities in bipolar patients of African ancestry. Future bipolar biomarker studies with larger sample sizes focused on underrepresented populations will provide greater ancestry diversity in genomic medicine with greater applicability to diverse patient populations, serving to inform health care policies to address disparities in bipolar disorder.

PMID:35064520 | DOI:10.1007/s40615-022-01228-3

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Nevin Manimala Statistics

Measuring the urban land use efficiency of three urban agglomerations in China under carbon emissions

Environ Sci Pollut Res Int. 2022 Jan 22. doi: 10.1007/s11356-021-18124-8. Online ahead of print.

ABSTRACT

On the basis of DMSP/OLS and NPP-VIIRS night light images, this study realized carbon emission estimations based on the municipal level from 1999 to 2017, compensating for the characteristics of incomplete statistical data and different statistical calibers. On this basis, the epsilon-based measure (EBM) super-efficiency model and the global Malmquist-Luenberger (GML) index are used to measure the urban land use efficiency (ULUE) and urban land total factor productivity (ULTFP) of the three urban agglomerations under the carbon emission constraints from 1999 to 2017. The following conclusions are drawn through research. (1) The correlation coefficient between the total value of night light pixels and energy consumption carbon emissions was relatively high in the three major urban agglomerations during 1999-2017, and they all passed the significance test of 1%. (2) The ULUE of the three major urban agglomerations generally shows a downward trend and then an upward trend, and spatial heterogeneity is obvious. The spatial distribution of the average level of ULUE is Pearl River Delta Urban Agglomeration (PRDUA) > Yangtze River Delta Urban agglomeration (YRDUA) > Beijing-Tianjin-Hebei Urban agglomeration (BTHUA). (3) The ULTFP of the three major urban agglomerations are all showing an increasing trend, but the geometric mean of URTFP in the PRDUA, BTHUA, and YRDUA decreases successively. Technological progress is the main driving force to promote the progress of ULTFP in each urban agglomeration. (4) The kernel density estimation shows a significant gap in ULUE between the three major urban agglomerations in China, and a phenomenon of polarization or multipolarization is observed. The main reason is the hysteresis of technology diffusion.

PMID:35064500 | DOI:10.1007/s11356-021-18124-8

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Nevin Manimala Statistics

Cholecystectomy Concomitant with Bariatric Surgery: Safety and Metabolic Effects

Obes Surg. 2022 Jan 22. doi: 10.1007/s11695-022-05889-1. Online ahead of print.

ABSTRACT

BACKGROUND: Obesity and fast weight loss in the postoperative period of bariatric surgery increase significantly the risk of cholelithiasis. Moreover, emerging evidence has pointed out the role of bile acids as possible metabolism and weight loss enhancers. This study aims to analyze the influence of cholecystectomy (CL) concomitant with bariatric surgery on weight loss, metabolic repercussions, and postoperative morbidity.

STUDY DESIGN: Retrospective cohort study. A total of 363 medical records were analyzed between 2002 and 2017, with 255 patients divided into four groups: with concomitant CL: sleeve gastrectomy (SG + CL group) and Roux-en-Y gastric bypass (GB + CL group); without concomitant CL: sleeve gastrectomy (SG group) and RYGB (GB group).

RESULTS: CL concomitant with bariatric surgery is not related to worse long-term metabolic outcomes when compared to isolated bariatric surgery. In the postoperative follow-up of the isolated bariatric surgeries, 18 (16.5%) patients underwent cholecystectomy. There was no statistical difference between the groups regarding post-surgical complications.

CONCLUSION: CL did not lead to worse metabolic outcomes and was also not related to a higher incidence of postoperative complications. Cholelithiasis and cholecystitis are important concerns in the postoperative period of bariatric surgery and a careful evaluation of the concomitant procedure should be performed.

PMID:35064462 | DOI:10.1007/s11695-022-05889-1

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Nevin Manimala Statistics

Exploring environment sensitivity to fiscal and monetary policies in China: using ecological footprints as a contemporary proxy

Environ Sci Pollut Res Int. 2022 Jan 22. doi: 10.1007/s11356-021-18085-y. Online ahead of print.

ABSTRACT

This paper is a pioneer attempt using ecological footprints, the latest environment sensitivity proxy to be regressed, contributing to the scarce literature concerning one of the most burning global dilemmas of the era. For econometric analysis, fiscal and monetary tools, green energy consumption, and economic growth have been chosen as a set of regressors data spanning 1990-2020 in China facing the highest total ecological footpaths. And giving priority to the relevancy, reliability, and robustness autoregressive distributed lag (ARDL), fully modified ordinary least squares (FMOLS) and dynamic ordinary least squares (DOLS) have been applied for instant and eternal sensitivities, followed by the widely used stationarity tests (augmented Dicky-Fuller and Phillips-Perron tests) and bounds test. Granger’s ordeal has also noticed causal inferences. Cointegrating findings are robust across all techniques, and ARDL results remain consistent regardless of short and prolonged duration. We witness positive and statistically significant (at 10%) responsiveness of ecological footprints (EFP) to China’s rapid gross domestic output (GDP) growth per capita fueled by fossil fuels (primarily coal). Contrarily, negative/inverse sensitivity to expansionary fiscal (higher government expenditures, GEx), contractionary monetary policies (higher policy rate, DR), and green energy use (REnC). Besides, EFP demonstrates statistically significant reciprocal interconnection with GDP and REnC but a unidirectional connection with DR (DR → EFP). GDP has effective collaboration with REnC and GEx whereas single-sided relationship DR as (GDP → DR). Finally, some policy choices are endorsed.

PMID:35064496 | DOI:10.1007/s11356-021-18085-y

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Nevin Manimala Statistics

Application of cumulative summation (CUSUM) method and mathematical model to evaluate the learning effect in central venous catheter port implantation

Jpn J Radiol. 2022 Jan 22. doi: 10.1007/s11604-021-01242-1. Online ahead of print.

NO ABSTRACT

PMID:35064442 | DOI:10.1007/s11604-021-01242-1