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Nevin Manimala Statistics

Safety and efficacy of cryoablation versus radiofrequency ablation for stage Ⅰ non-small-cell lung cancer

Zhonghua Yi Xue Za Zhi. 2022 Aug 23;102(31):2458-2464. doi: 10.3760/cma.j.cn112137-20220109-00060.

ABSTRACT

Objective: To compare the safety and efficacy of cryoablation(CYA) and radiofrequency ablation(RFA) for stageⅠnon-small cell lung cancer(NSCLC). Methods: From January 2014 to January 2019, 90 eligible patients [48 males, 42 females, age: 39-85(63.6±10.1)years] in the First Affiliated Hospital of Zhengzhou University met the inclusion criteria were retrospectively analyzed. They were divided into 2 groups according to different treatment methods(group CYA and group RFA). The duration of operation, intraoperative pain, local tumor progression rate and the incidence of complications were compared. The progression-free survival (PFS) and overall survival (OS) of the 2 groups were estimated by Kaplan-Meier curves, and were compared by using log-rank test. Results: The clinical data and tumor situation of the patients between two groups did not show significant differences. The mean duration of operation for group CYA was longer than that for group RFA [(73.5±17.2)min vs (51.4±18.7)min, P<0.001];the mean intraoperative visual analogue score(VAS)for group CYA was lower than that for group RFA (0.53±0.89 vs 3.44±2.44, P<0.001). The median follow-up period time were 53 months and 52 months for group CYA and RFA. At the end of the study, The local tumor progression rate was 31.6%(12/38) and 25.0%(13/52) for group CYA and group RFA, the difference were not statistically(P=0.491). There was no statistical difference for progress-free survival(PFS)between group CYA and group RFA[51(95%CI:40.3-55.0)months)vs 44(95%CI:37.2-54.1) months, P=0.649]. The median OS was not reached in both groups. The most common complications observed in the two groups were pneumothorax, hemorrhage and pleural effusion. There was no statistical difference in the incidence rates [42.1%(16/38) for group CYA vs 28.8% (15/52)for group RFA, P=0.191]. The incidence rate of pleural effusion for group CYA was higher than that for group RFA [26.3%(10/38)vs 5.8%(3/52), P=0.006]. The incidence rates of pneumothorax and hemorrhage had no statistical difference between the two groups [13.3%(5/38)vs 13.5% (7/52) and 15.8%(6/38) vs 9.6% (5/52), all P>0.05]. Conclusion: Compared with RFA,CYA shows no significant differences in the same efficacy and safety for treating patients with stage Ⅰ NSCLC, with less intraoperative pain but longer operative duration.

PMID:36000376 | DOI:10.3760/cma.j.cn112137-20220109-00060

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Nevin Manimala Statistics

A complicated Glenn procedure: risk factors and association with adverse long-term neurodevelopmental and functional outcomes

Cardiol Young. 2022 Aug 24:1-8. doi: 10.1017/S104795112200261X. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine potentially modifiable risk factors for a complicated Glenn procedure (cGP) and whether a cGP predicted adverse neurodevelopmental and functional outcomes. A cGP was defined as post-operative death, heart transplant, extracorporeal life support, Glenn takedown, or prolonged ventilation.

METHODS: All 169 patients having a Glenn procedure from 2012 to 2017 were included. Neurodevelopmental assessments were performed at age 2 years in consenting survivors (n = 156/159 survivors). The Bayley Scales of Infant and Toddler Development-3rd Edition (Bayley-III) and the Adaptive Behavior Assessment System-2nd Edition (ABAS-II) were administered. Adaptive functional outcomes were determined by the General Adaptive Composite (GAC) score from the ABAS-II. Predictors of outcomes were determined using univariate and multiple variable linear or Cox regressions.

RESULTS: Of patients who had a Glenn procedure, 10/169 (6%) died by 2 years of age and 27/169 (16%) had a cGP. Variables statistically significantly associated with a cGP were the inotrope score on post-operative day 1 (HR 1.04, 95%CI 1.01, 1.06; p = 0.010) and use of inhaled nitric oxide post-operatively (HR 7.31, 95%CI 3.19, 16.76; p < 0.001). A cGP was independently statistically significantly associated with adverse Bayley-III Cognitive (ES -10.60, 95%CI -17.09, -4.11; p = 0.002) and Language (ES -11.43, 95%CI -19.25, -3.60; p = 0.004) scores and adverse GAC score (ES -14.89, 95%CI -22.86, -6.92; p < 0.001).

CONCLUSIONS: Higher inotrope score and inhaled nitric oxide used post-operatively were associated with a cGP. A cGP was independently associated with adverse 2-year neurodevelopmental and functional outcomes. Whether early recognition and intervention for risk of a cGP can prevent adverse outcomes warrants study.

PMID:36000320 | DOI:10.1017/S104795112200261X

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Nevin Manimala Statistics

Relationship between CH3OD Abundance and Temperature in the Orion KL Nebula

J Phys Chem A. 2022 Aug 24. doi: 10.1021/acs.jpca.2c01309. Online ahead of print.

ABSTRACT

The relative abundances of singly deuterated methanol isotopologues, [CH2DOH]/[CH3OD], in star-forming regions deviate from the statistically expected ratio of 3. In Orion KL, the nearest high-mass star-forming region to Earth, the singly deuterated methanol ratio is about 1, and the cause for this observation has been explored through theory for nearly three decades. We present high-angular resolution observations of Orion KL using the Atacama Large Millimeter/submillimeter Array to map small-scale changes in CH3OD column density across the nebula, which provide a new avenue to examine the deuterium chemistry during star and planet formation. By considering how CH3OD column densities vary with temperature, we find evidence of chemical processes that can significantly alter the observed gas-phase column densities. The astronomical data are compared with existing theoretical work and support D-H exchange between CH3OH and heavy water (i.e., HDO and D2O) at methanol’s hydroxyl site in the icy mantles of dust grains. The enhanced CH3OD column densities are localized to the Hot Core-SW region, a pattern that may be linked to the coupled evolution of ice mantle chemistry and star formation in giant molecular clouds. This work provides new perspectives on deuterated methanol chemistry in Orion KL and informs considerations that may guide future theoretical, experimental, and observational work.

PMID:36000316 | DOI:10.1021/acs.jpca.2c01309

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Nevin Manimala Statistics

Development and preliminary validation of the chronic obstructive pulmonary disease scale quality of life instruments for chronic diseases-chronic obstructive pulmonary disease based on classical test theory and generalizability theory

Chron Respir Dis. 2022 Jan-Dec;19:14799731221104099. doi: 10.1177/14799731221104099.

ABSTRACT

Quality of life (QOL) in patients with Chronic obstructive pulmonary disease (COPD) is a major global concern in respiratory care with the specific instruments used rarely being developed using a modular approach. This paper is aimed to develop the COPD scale of the system of QOL Instruments for Chronic Diseases (QLICD-COPD) by the modular approach based on Classical Test Theory and Generalizability Theory (GT). 114 inpatients with COPD were used to provide the data measuring QOL three times before and after treatments. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness employing correlation analysis, factor analyses, multi-trait scaling analysis, and also GT analysis. The Results showed that Multi-trait scaling analysis, correlation and factor analyses confirmed good construct validity and criterion-related validity with almost all correlation coefficients or factor loadings being above 0.40. The internal consistency α and test-retest reliability coefficients (Pearson r and Intra-class correlations ICC) for all domains except for the social domain were larger than 0.70, ranging between 0.70-0.86 with r = 0.85 for the overall. The overall score and scores for physical and the specific domains had statistically significant changes after treatments with moderate effect size SRM (standardized response mean) ranging from 0.32 to 0.44. All G-coefficients and index of dependability were all greater than 0.80 exception of social domain (0.546 and 0.500 respectively), confirming the reliability of the scale further. It concluded that the QLICD-COPD has good validity, reliability, and moderate responsiveness, and can be used as the QOL instrument for patients with COPD.

PMID:36000309 | DOI:10.1177/14799731221104099

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Nevin Manimala Statistics

Clinical characteristics and outcomes of patients with COVID-19 and psoriasis

J Med Virol. 2022 Aug 24. doi: 10.1002/jmv.28085. Online ahead of print.

ABSTRACT

OBJECTIVES: To summarize the clinical characteristics and explore the role of treatment types in outcomes among psoriasis patients with Coronavirus Disease 2019 (COVID-19).

METHODS: The principal summary measures used were pooled prevalence and risk ratio (RR) with 95% confidential interval (CI). R statistic software was used for all the analysis.

RESULTS: A total of 19 studies including 4073 psoriasis patients with COVID-19 were eligible for the meta-analysis. The overall hospitalization rate is about 20.2% (95% CI, 12.7% – 28.7%), and changed to be 18.0 (95% CI, 9.9% – 27.6%) or 14.1 (95% CI, 5.9% – 24.6%) after systemic or biologic treatment. Moreover, the overall fatality rate is 1.5% (95% CI, 0.4% – 3.0%), and turned to be 0.7 (95% CI, 0 – 2.0%) or 0.5 (95% CI, 0 – 2.2%) after systemic or biologic therapy. Notably, a lower hospitalization risk ratio was found in patients receiving biologic therapy than those receiving other treatments (RR = 0.62, 95%CI, 0.42-0.94). The results were consistent after sensitivity analysis and trim-and-fill analysis.

CONCLUSIONS: Systemic, especially biologic therapy could lessen the clinical severity in psoriasis patients with COVID-19. Our finding will help to guide current recommendations and provide a reference for clinical decision-making. This article is protected by copyright. All rights reserved.

PMID:36000295 | DOI:10.1002/jmv.28085

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Nevin Manimala Statistics

Differences in set-based tests for sparse alternatives when testing sets of outcomes compared to sets of explanatory factors in genetic association studies

Biostatistics. 2022 Aug 24:kxac036. doi: 10.1093/biostatistics/kxac036. Online ahead of print.

ABSTRACT

Set-based association tests are widely popular in genetic association settings for their ability to aggregate weak signals and reduce multiple testing burdens. In particular, a class of set-based tests including the Higher Criticism, Berk-Jones, and other statistics have recently been popularized for reaching a so-called detection boundary when signals are rare and weak. Such tests have been applied in two subtly different settings: (a) associating a genetic variant set with a single phenotype and (b) associating a single genetic variant with a phenotype set. A significant issue in practice is the choice of test, especially when deciding between innovated and generalized type methods for detection boundary tests. Conflicting guidance is present in the literature. This work describes how correlation structures generate marked differences in relative operating characteristics for settings (a) and (b). The implications for study design are significant. We also develop novel power bounds that facilitate the aforementioned calculations and allow for analysis of individual testing settings. In more concrete terms, our investigation is motivated by translational expression quantitative trait loci (eQTL) studies in lung cancer. These studies involve both testing for groups of variants associated with a single gene expression (multiple explanatory factors) and testing whether a single variant is associated with a group of gene expressions (multiple outcomes). Results are supported by a collection of simulation studies and illustrated through lung cancer eQTL examples.

PMID:36000269 | DOI:10.1093/biostatistics/kxac036

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Nevin Manimala Statistics

PMED: Optimal Bayesian Platform Trial Design with Multiple Endpoints

J Biopharm Stat. 2022 Jul 4;32(4):567-581. doi: 10.1080/10543406.2022.2080692. Epub 2022 Jun 15.

ABSTRACT

In oncology drug development, indication selection and optimal dose identification are the primary objectives for the early phase of clinical trials and could significantly impact the probability of success. Master protocols, e.g., basket trial, umbrella trial, and platform trial, have become popular in practice considering the connection of trial designs with multiple indications and treatment candidates. They also enable the optimization of operational resources and maximize the capability of data-driven decision-making. However, most of the available designs are developed with the efficacy endpoint only for treatment effect estimation and testing, without consideration of the safety end point. Thus, it often lacks a comprehensive quantitative framework to allow optimal treatment selection, which could put future development at risk. We propose an optimal Bayesian platform trial design with multiple end points (PMED) to characterize the overall benefit-risk profile. The design is further extended to allow treatment and indication selection within and across arms, with continuous monitoring on multiple interim analyses for futility. In addition, we propose dynamic borrowing across arms to increase the efficiency and accuracy of estimation given the level of similarity across arms. A hierarchical hypothesis structure is utilized to achieve optimal indication and treatment combination selection by controlling family-wise error. Through simulation studies, we show that PMED is a robust design under the studied scenarios with superb power and controlled family-wise error rate.

PMID:36000260 | DOI:10.1080/10543406.2022.2080692

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Nevin Manimala Statistics

A heteroskedastic model of Park Grass spring hay yields in response to weather suggests continuing yield decline with climate change in future decades

J R Soc Interface. 2022 Aug;19(193):20220361. doi: 10.1098/rsif.2022.0361. Epub 2022 Aug 24.

ABSTRACT

UK grasslands perform important environmental and economic functions, but their future productivity under climate change is uncertain. Spring hay yields from 1902 to 2016 at one site (the Park Grass Long Term Experiment) in southern England under four different fertilizer regimes were modelled in response to weather (seasonal temperature and rainfall). The modelling approach applied comprised: (1) a Bayesian model comparison to model parametrically the heteroskedasticity in a gamma likelihood function; (2) a Bayesian varying intercept multiple regression model with an autoregressive lag one process (to incorporate the effect of productivity in the previous year) of the response of hay yield to weather from 1902 to 2016. The model confirmed that warmer and drier years, specifically, autumn, winter and spring, in the twentieth and twenty-first centuries reduced yield. The model was applied to forecast future spring hay yields at Park Grass under different climate change scenarios (HadGEM2 and GISS RCP 4.5 and 8.5). This application indicated that yields are forecast to decline further between 2020 and 2080, by as much as 48-50%. These projections are specific to Park Grass, but implied a severe reduction in grassland productivity in southern England with climate change during the twenty-first century.

PMID:36000226 | DOI:10.1098/rsif.2022.0361

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Nevin Manimala Statistics

Functional Activity After Flatfoot Reconstruction With Lateral Column Lengthening

Foot Ankle Spec. 2022 Aug 23:19386400221116467. doi: 10.1177/19386400221116467. Online ahead of print.

ABSTRACT

BACKGROUND: The objective of this study was to evaluate return to activity following flatfoot reconstruction with lateral column lengthening (LCL) by assessing functional postoperative data and identifying patient characteristics associated with poor function following surgery.

METHODS: Consecutive patients that underwent operative flatfoot correction including LCL and other necessary procedures from 2014 to 2019 by 3 fellowship trained foot and ankle orthopedic surgeons were retrospectively administered Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) and FAAM Sports questionnaires with no preoperative scoring available. Patient demographic factors, comorbidities, and radiographic features were evaluated as predictors of outcome scores to simulate return to activity. Statistical analysis, including student’s t-tests and analysis of variance, was performed.

RESULTS: A total of 54 patients were included. A body mass index (BMI) of 30 kg/m2 or greater was associated with a lower ADL score (P = .002) and Sports score (P = .002). Preoperative hindfoot valgus of 9° or higher was associated with higher ADL scores (P = .040). Neither age nor any flatfoot radiographic parameters yielded significant differences in functional scores.

CONCLUSION: This study demonstrated relatively high average FAAM scores in both the ADL and the sports subscales, consistent with previous studies. This study also identified lower BMI and greater preoperative hindfoot valgus as potential predictors of improved functional outcome following reconstruction.

LEVEL OF EVIDENCE: Level III: Retrospective case control.

PMID:36000219 | DOI:10.1177/19386400221116467

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Nevin Manimala Statistics

Prediction parameters of left ventricular diastolic dysfunction improvement in patients after acute coronary syndrome

Acta Clin Belg. 2022 Aug 24:1-9. doi: 10.1080/17843286.2022.2114678. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this study was to examine the effects of comprehensive cardiac rehabilitation (CCR) in patients after acute coronary syndrome (ACS) resolved by percutaneous coronary intervention (PCI) on left ventricular diastolic dysfunction (LVDD) and to extract the parameters that have the greatest influence on LVDD improvement.

METHODS: The study included 85 subjects who were divided into intervention (N = 56) and control (N = 29) groups depending on CCR attendance. Initially and after 12 weeks, patients of both groups were subjected to echocardiography to assess LVDD, as well as CPET to assess improvement in functional capacity.

RESULTS: The study showed that 23 patients (27.1%) of both groups demonstrated the improvement of LVDD degree. The improvement of the LVDD degree in the intervention group was significant, whereas in the control group, it did not change (a one-degree improvement in 22 (39.3%) patients of the intervention group (p < 0.001) and only 1 (3.4%) (p > 0.05) in the control group). Multivariate binary logistic regression showed that key parameters in LVDD improvement were participation in the CCR, E/A ratio and haemoglobin value. We created a model, for prediction of LVDF improvement, with a cut-off value of 33 (area = 0.9, p < 0.0005), a sensitivity of 87.0% and a specificity of 85.5%.

CONCLUSIONS: CCR can be used as an effective non-pharmacological measure to improve LVDD and functional capacity in patients after ACS. The statistical model may have practical application in prediction of clinical benefit in such a group of patients.

PMID:36000216 | DOI:10.1080/17843286.2022.2114678