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Nevin Manimala Statistics

Is there heterogeneity and moderating effect of carbon trading pilot in promoting total factor productivity?

Environ Sci Pollut Res Int. 2023 Dec 15. doi: 10.1007/s11356-023-31426-3. Online ahead of print.

ABSTRACT

In order to analyze what factors may affect the role of carbon trading pilot in promoting total factor productivity, this paper constructs DID model combining information of listed companies with city and industry characteristics. The moderating effect model is used to research the influence of firms’ induced behavior. The results show that (1) the characteristics of a city can influence the impact of carbon trading pilot, which is associated with the city’s dominant industry, resource endowment, and geographical location; (2) the effect of carbon trading pilot is heterogeneous, primarily indicating a stronger effect on high-emission industries, while having no significant impact on high-pollution industries; and (3) the induced behavior of businesses, such as increasing green innovation and environmental protection expenditure, potentially “crowding out” the effects of the carbon trading pilot.

PMID:38097841 | DOI:10.1007/s11356-023-31426-3

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The Acceptance of Indirect Treatment Comparison Methods in Oncology by Health Technology Assessment Agencies in England, France, Germany, Italy, and Spain

Pharmacoecon Open. 2023 Dec 14. doi: 10.1007/s41669-023-00455-6. Online ahead of print.

ABSTRACT

INTRODUCTION: Randomized controlled trials (RCTs) are the gold standard when comparing treatment effectiveness, and Health Technology Assessment (HTA) agencies state a clear preference for such direct comparisons. When these are not available, an indirect treatment comparison (ITC) is an alternative option. The objective of this study was to assess the acceptance of ITC methods by HTA agencies across England, France, Germany, Italy, and Spain, using oncology cases for a homogeneous sample of HTA evaluations.

METHODS: The study was conducted on the PrismAccess database in May 2021 to retrieve HTA evaluation reports for oncology treatments for solid tumors, in which an ITC was presented. The analysis was restricted to HTA evaluation reports published between April 2018 and April 2021 in England, France, Germany, Italy, and Spain. Identified HTA evaluation reports were screened and reviewed by two independent reviewers. For each ITC presented, the methodology and its acceptance by the HTA agency were analyzed.

RESULTS: Five hundred and forty-three HTA evaluation reports were identified, of which 120 (22%) presented an ITC. This proportion was the highest in England (51%) and lowest in France (6%). The overall acceptance rate of ITC methods was 30%, with the highest in England (47%) and lowest in France (0%). Network meta-analysis (NMA; 23%) was the most commonly used ITC technique, with a 39% acceptance rate overall, followed by Bucher ITC (19%; 43% acceptance rate) and matching-adjusted indirect comparison (13%; 33% acceptance rate). The most common criticisms of the ITC methods from HTA agencies related to data limitations (heterogeneity and lack of data; 48% and 43%, respectively) and the statistical methods used (41%).

CONCLUSIONS: The generally low acceptance rate of ITC methods by HTA agencies in oncology suggests that, whilst in the absence of a direct comparison ITCs may provide relevant evidence, this evidence is not widely considered sufficient for the purpose of HTA evaluations. The perception of ITC methods for the purpose of HTA evaluations varies substantially between countries. There is a need for further clarity on the properties of ITC techniques and the assessment of their results as ITC methods continue to evolve quickly and further techniques may become available in the future.

PMID:38097828 | DOI:10.1007/s41669-023-00455-6

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Nevin Manimala Statistics

Rapid, free-breathing non-contrast MRI for first-line imaging evaluation of ovarian torsion in the emergency department

Pediatr Radiol. 2023 Dec 14. doi: 10.1007/s00247-023-05827-y. Online ahead of print.

ABSTRACT

BACKGROUND: Transabdominal ultrasound (US) is first-line imaging to evaluate ovaries in girls presenting to the emergency department (ED) with suspected ovarian torsion. Ovaries may be difficult to visualize sonographically; therefore, prompt diagnosis using US alone can be challenging. Rapid MRI as first-line imaging may help streamline patient throughput, especially with increasing MRI availability in the ED.

OBJECTIVE: To assess feasibility of rapid MRI for diagnosis of ovarian torsion.

MATERIALS AND METHODS: A retrospective, single-center IRB approved study of MRI performed in female pediatric patients presenting with abdominopelvic pain from August 2022 to January 2023. Imaging occurred according to one of three clinical pathways (US-first approach vs MRI-first approach vs US + MRI-second-line approach). A rapid three-sequence free-breathing MRI protocol was utilized. Frequency of ovarian torsion and secondary diagnoses was recorded. Length of MR scan time, time from ED arrival to time of diagnosis, and whether patient had US prior to MR exam were obtained. A historical cohort of patients with US only performed for assessment of ovarian torsion were evaluated for length of the US examination and time from ED arrival to time of diagnosis. Intervals were compared using the uncorrected Fisher’s least significant difference and Turkey’s multiple comparison tests.

RESULTS: A total of 140 MRI exams (mean age 14.6 years) and 248 historical US exams (mean age 13.5 years) were included. Of the patients with MRI, 41 (29%) patients were imaged with US + MRI and 99 (71%) imaged with MRI only; 4% (6/140) MR exams were suspicious for ovarian torsion, with one true positive case (1/6 TP) and 5 false positive cases (5/6 FP); 26.4% (37/140) of exams had secondary diagnoses. Median MRI scan time was 11.4 min (4.4) vs median historical US scan time was 24.1 min (19.7) (P<0.001). Median time from arrival in ED to MRI read was 242 (140). Median time from arrival in ED to US only read was 268 min (148). This was not a statistically significant difference when compared to the MRI only cohort.

CONCLUSION: First-line MRI imaging for evaluation of ovarian torsion is a rapid and feasible imaging modality for female patients in the emergent setting.

PMID:38097821 | DOI:10.1007/s00247-023-05827-y

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Characterization of the Microbial Community Structures, Soil Chemical Properties, and Enzyme Activity of Stellera chamaejasme (Thymelaeaceae) and Its Associated Forages in Alpine Grassland of Northwestern China

Curr Microbiol. 2023 Dec 15;81(1):39. doi: 10.1007/s00284-023-03554-z.

ABSTRACT

The invasion of toxic weeds was detrimental to the growth of original vegetation and speed up the degraded grasslands. The purpose of this study was to explore the difference in microbial community, soil physicochemical properties, and enzyme activity in the rhizosphere of Stellera chamaejasme and its associated forages (Stipa purpurea and Polygonum viviparum). The rhizosphere soil microbial communities of S. chamaejasme and its associated forages were determined by high-throughput sequencing technology, the physicochemical properties, and enzyme activities were also measured using soil chemical methods. We performed biological statistical analyses to explore the correlation of rhizosphere micro-ecological environment between the invading poisonous herb S. chamaejasme and its associated forages. The Ascomycota community in the rhizosphere soil of S. chamaejasme was significantly decreased when compared with its associated forages. S. chamaejasme and S. purpurea had a similar bacterial composition, while the rhizosphere of P. viviparum was associated with more Acidobacteria and Bacteroidetes. The RDA analysis showed S. chamaejasme had highly correlated with acid proteinase, invertase, polyphenol oxidase, cellulose, and neutral protease and S. purpurea had highly associated with N-acetyl-beta-D-glucosaminidase, β-D-Glucosidase, and the P. viviparum had highly associated with total phosphorus, total nitrogen, ammonium nitrogen, soil organic matter, pH, acid phosphatase, and catalase. Along with the invasion of S. chamaejasme, the microbial composition, soil physicochemical properties, and enzyme activity of the growing area changed considerably compared with the associated forages. Taken together, our results suggested that the composition and diversity of microbial communities associated with S. chamaejasme and its associated forages exhibited different patterns, and the rhizosphere soil microbial communities in different plants were regulated by different environmental factors in this alpine grassland ecosystem.

PMID:38097817 | DOI:10.1007/s00284-023-03554-z

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Association between gut microbiota at 3.5 years of age and body mass index at 5 years: results from two French nationwide birth cohorts

Int J Obes (Lond). 2023 Dec 15. doi: 10.1038/s41366-023-01442-x. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVES: The relationship between gut microbiota and changes in body mass index (BMI) or pediatric overweight in early life remains unclear, and information regarding the preterm population is scarce. This study aimed to investigate how the gut microbiota at 3.5 years of age is associated with (1) later BMI at 5 years, and (2) BMI z-score variations between 2 and 5 years in children from two French nationwide birth cohorts.

SUBJECTS/METHODS: Bacterial 16S rRNA gene sequencing was performed to profile the gut microbiota at 3.5 years of age in preterm children (n = 143, EPIPAGE 2 cohort) and late preterm/full-term children (n = 369, ELFE cohort). The predicted abundances of metabolic functions were computed using PICRUSt2. Anthropometric measurements were collected at 2 and 5 years of age during medical examinations or retrieved from children’s health records. Statistical analyses included multivariable linear and logistic regressions, random forest variable selection, and MiRKAT.

RESULTS: The Firmicutes to Bacteroidetes (F/B) ratio at 3.5 years was positively associated with the BMI z-score at 5 years. Several genera were positively ([Eubacterium] hallii group, Fusicatenibacter, and [Eubacterium] ventriosum group) or negatively (Eggerthella, Colidextribacter, and Ruminococcaceae CAG-352) associated with the BMI z-scores at 5 years. Some genera were also associated with variations in the BMI z-scores between 2 and 5 years of age. Predicted metabolic functions, including steroid hormone biosynthesis, biotin metabolism, glycosaminoglycan degradation, and amino sugar and nucleotide sugar metabolism, were associated with lower BMI z-scores at 5 years. The unsaturated fatty acids biosynthesis pathway was associated with higher BMI z-scores.

CONCLUSIONS: These findings indicate that the gut microbiota at 3.5 years is associated with later BMI during childhood, independent of preterm or term birth, suggesting that changes in the gut microbiota that may predispose to adult obesity begin in early childhood.

PMID:38097759 | DOI:10.1038/s41366-023-01442-x

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Nevin Manimala Statistics

Soil microbial improvement using enriched vinasse as a new abundant waste

Sci Rep. 2023 Dec 14;13(1):22279. doi: 10.1038/s41598-023-49401-w.

ABSTRACT

This study proposes the use of vinasse, an inexpensive and readily available waste biopolymer, as a fundamental component of a waste culture medium that can enhance the effectiveness and cost-efficiency of the microbial-induced calcite precipitation (MICP) method for sustainable soil improvement. Vinasse enriched with urea, sodium caseinate, or whey protein concentrate is employed to optimize bacterial growth and urease activity of Sporosarcina pasteurii (S. pasteurii) bacterium. The best culture medium is analyzed using Taguchi design of experiments (TDOE) and statistical analysis, considering the concentration of vinasse and urea as effective parameters during growth time. To test the best culture medium for bio-treated soil, direct shear tests were performed on loose and bio-treated sand. The results demonstrate a substantial cost reduction from $0.455 to $0.005 per liter when using the new culture medium (vinasse and urea) compared to the conventional Nutrient Broth (NB) culture medium. Additionally, the new medium enhances soil shear strength, increasing the friction angle by 2.5 degrees and cohesion to 20.7 kPa compared to the conventional medium. Furthermore, the recycling of vinasse as a waste product can promote the progress of a circular economy and reduce environmental pollution. As ground improvement is essential for many construction projects, especially those that require high shear strength or are built on loose soil, this study provides a promising approach to achieving cost-effective and sustainable soil microbial improvement using enriched vinasse.

PMID:38097757 | DOI:10.1038/s41598-023-49401-w

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Nevin Manimala Statistics

Effects of symptom management program on selected health outcomes among older people with chronic obstructive pulmonary disease: a quasi-experimental study

Sci Rep. 2023 Dec 14;13(1):22265. doi: 10.1038/s41598-023-49654-5.

ABSTRACT

Older adults have limitations from their aging process and chronic disease, so developed interventions must pay attention and concern to their aging degeneration and needs. This study aims to study the effects of a symptom management program on selected health outcomes among older people with chronic obstructive pulmonary disease. The quasi-experimental research included the 15 older patients in the control group receiving routine nursing care, while the other 15 in the experimental group received a 4-week symptom management program. First, the general information was analyzed using descriptive statistics. Next, the average health outcomes were analyzed using independent and dependent t-tests, Mann-Whitney U Test, and Wilcoxon Signed Ranks Test. In addition, the readmission rate was compared using Fisher’s Exact Test. Results revealed that most of the older patients were men (96.7%), aged 60-88 years (Mean = 71.57, SD = 7.75), with a smoking history (93.3%). The improvements were found in dyspnea (p < .01), its severity during activities (p < .01), and the quality of life (p = .04) among patients who attended the program. However, both groups did not have a different pulmonary function (p = .25) and the proportion of readmission within 28 days (p = .50). This study shows that the symptom management program can reduce dyspnea and severity during activities and improve the quality of life. Older people suffer from chronic obstructive pulmonary disease, especially when experiencing dyspnea. Therefore, it is crucial to have a symptom management program for older patients, especially a program developed to respond to changes in the aging process and the limitations of older people. This developed program was age-friendly to deal with symptoms and improve quality of life. However, this program should be explored in typical situations without the effects of the coronavirus disease (COVID-19) pandemic. In addition, more extensive population-based studies and randomized controlled trials should be adopted to increase credibility and ensure generalization.Clinical Trial Registration Number: https://osf.io/6sj7y (October 4, 2021).

PMID:38097752 | DOI:10.1038/s41598-023-49654-5

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Olaparib maintenance versus placebo in platinum-sensitive non-small cell lung cancer: the Phase 2 randomized PIPSeN trial

Br J Cancer. 2023 Dec 14. doi: 10.1038/s41416-023-02514-5. Online ahead of print.

ABSTRACT

BACKGROUND: Platinum-sensitivity is a phenotypic biomarker of Poly (ADP-ribose) polymerase inhibitors (PARPi) sensitivity in histotypes where PARPi are approved. Approximately one-third of non-small cell lung cancers (NSCLC) are platinum-sensitive. The double-blind, randomized phase II PIPSeN (NCT02679963) study evaluated olaparib, a PARPi, as maintenance therapy for patients with platinum-sensitive advanced NSCLC.

METHODS: Chemonaïve patients with ECOG performance status of 0-1, platinum-sensitive, EGFR- and ALK-wild-type, stage IIIB-IV NSCLC were randomized (R) to receive either olaparib (O) maintenance or a placebo (P). The primary objective was progression-free survival (PFS) from R. Secondary objectives included overall survival (OS) and safety. With an anticipated hazard ratio of 0.65, 144 patients were required to be randomized, and approximately 500 patients enrolled.

RESULTS: The trial was prematurely terminated because anti-PD(L)1 therapy was approved during the trial recruitment. A total of 182 patients were enrolled, with 60 patients randomized: 33 and 27 in the O and P arms, respectively. Patient and tumor characteristics were well-balanced between arms, except for alcohol intake (33% vs 11% in the O and P arms, respectively, p = 0.043). The median PFS was 2.9 and 2.0 months in the O and P arms, respectively (logrank p = 0.99). The median OS was 9.4 and 9.5 months in the O and P arms, respectively (p = 0.28). Grade ≥3 toxicities occurred in 15 and 8 patients in O and P arms, with no new safety concerns.

CONCLUSION: PIPSeN was terminated early after enrollment of only 50% of the pre-planned population, thus being statistically underpowered. Olaparib maintenance did neither improve median PFS nor OS in this patient population.

PMID:38097741 | DOI:10.1038/s41416-023-02514-5

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Patient-specific computational models of retinal prostheses

Sci Rep. 2023 Dec 14;13(1):22271. doi: 10.1038/s41598-023-49580-6.

ABSTRACT

Retinal prostheses stimulate inner retinal neurons to create visual perception for blind patients. Implanted arrays have many small electrodes. Not all electrodes induce perception at the same stimulus amplitude, requiring clinicians to manually establish a visual perception threshold for each one. Phosphenes created by single-electrode stimuli can also vary in shape, size, and brightness. Computational models provide a tool to predict inter-electrode variability and automate device programming. In this study, we created statistical and patient-specific field-cable models to investigate inter-electrode variability across seven epiretinal prosthesis users. Our statistical analysis revealed that retinal thickness beneath the electrode correlated with perceptual threshold, with a significant fixed effect across participants. Electrode-retina distance and electrode impedance also correlated with perceptual threshold for some participants, but these effects varied by individual. We developed a novel method to construct patient-specific field-cable models from optical coherence tomography images. Predictions with these models significantly correlated with perceptual threshold for 80% of participants. Additionally, we demonstrated that patient-specific field-cable models could predict retinal activity and phosphene size. These computational models could be beneficial for determining optimal stimulation settings in silico, circumventing the trial-and-error testing of a large parameter space in clinic.

PMID:38097732 | DOI:10.1038/s41598-023-49580-6

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Safety profile of darolutamide versus placebo: a systematic review and meta-analysis

Prostate Cancer Prostatic Dis. 2023 Dec 14. doi: 10.1038/s41391-023-00775-y. Online ahead of print.

ABSTRACT

BACKGROUND: Darolutamide is an androgen receptor pathway inhibitor (ARPI) used in patients with prostate cancer (PC). In pivotal trials, it has demonstrated a favorable toxicity profile. There are no head-to-head comparison studies between the different ARPIs, but the efficacy of these drugs seems to be similar making the toxicity profile a key element for treatment selection.

METHODS: We conducted a systematic review of all clinical trials assessing treatment with darolutamide for patients with PC using placebo as the control using the PubMed/Medline and Cochrane library databases. We also performed a meta-analysis to compare the safety of darolutamide versus placebo evaluating adverse events (AE) leading to treatment discontinuation and the rate of the AE reported as “AE of interest” in the ARAMIS trial. The comparison among darolutamide and the placebo group in terms of safety and tolerability was performed using odds ratio (OR) as meta-analytic outcome.

RESULTS: We identified three articles comprising 2902 patients for the systematic review and meta-analysis (1652 treated with darolutamide and 1250 with placebo). Darolutamide did not increase AE leading to treatment discontinuation compared to placebo (pooled OR: 1.176, 95% CI 0.918-1.507, p = 0.633). Regarding the “AE of interest” there was no difference between darolutamide and placebo in terms of asthenia, cardiac arrhythmia, cardiac disorder, coronary artery disorder, depression mood disorder, falls, fatigue, heart failure, hot flushes, hypertension, mental-impairment disorder, rash, seizure and weight loss. The only “AE of interest” with a statistically significant difference in favor of placebo was bone fractures (pooled OR: 1.523, 95% CI 1.081-2.146).

CONCLUSIONS: In our systematic review and meta-analysis, darolutamide showed a toxicity profile comparable to placebo with the exception of bone fractures. In the absence of head-to-head comparison studies between the different ARPIs, the results of our research suggest a preferred use of darolutamide in the approved settings.

PMID:38097723 | DOI:10.1038/s41391-023-00775-y