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Nevin Manimala Statistics

On Enhancing Clinical Trial Data Sharing

JAMA Oncol. 2023 Oct 5. doi: 10.1001/jamaoncol.2023.3859. Online ahead of print.

NO ABSTRACT

PMID:37796491 | DOI:10.1001/jamaoncol.2023.3859

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Cardiovascular Risk in Prostate Cancer Patients Using Luteinizing Hormone-Releasing Hormone Agonists or a Gonadotropin-Releasing Hormone Antagonist

J Urol. 2023 Oct 5:101097JU0000000000003721. doi: 10.1097/JU.0000000000003721. Online ahead of print.

ABSTRACT

PURPOSE: LHRH agonists are believed to have higher cardiovascular risk relative to GnRH antagonists. However, previous studies have not consistently demonstrated this. We used real-world clinical practice data to evaluate differences in MACE risk between LHRH agonists compared to a GnRH antagonist following androgen deprivation therapy (ADT) initiation.

MATERIALS AND METHODS: We performed a retrospective analysis of data in the Decision Resources Group (now Clarivate) Real World Evidence repository, which represents >300 million US patients from 1991-2020 across all US regions. Patients with prostate cancer (PCa) who received at least 1 injection of ADT were included. The risks of MACE and all-cause mortality as independent endpoints were evaluated, Kaplan-Meier curves were constructed, and associations between MACE and all available confounding risk factors were evaluated by Cox regression analysis using Statistical Package for the Social Sciences (SPSS).

RESULTS: A total of 45,059 men with PCa treated with ADT were analyzed. Overall, the risks of MACE and all-cause mortality were slightly lower in the first year after ADT initiation compared to subsequent years. MACE risk was higher for the GnRH antagonist compared to LHRH agonists (HR = 1.62; 95% CI 1.21-2.18, P = .001). The risk of all-cause mortality was also higher for the GnRH antagonist vs LHRH agonists (HR = 1.87; 95% CI 1.39-2.52, P < .001).

CONCLUSIONS: The adjusted incidence of MACE was higher for men treated with the GnRH antagonist compared to the LHRH agonists. The demographic and risk factors with the greatest impact on MACE risk were higher age, baseline metastasis, oncology (vs urology) setting, personal MACE history, antagonist (vs agonist), tobacco history, White (vs Black) race, and lower BMI.

PMID:37796473 | DOI:10.1097/JU.0000000000003721

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Nevin Manimala Statistics

Drug utilization and medical expenses in psoriasis treatment at a dermatology hospital in Vietnam, 2019-2021

Ann Ig. 2023 Nov-Dec;35(6):670-682. doi: 10.7416/ai.2023.2572.

ABSTRACT

INTRODUCTION: Psoriasis is a persistent, chronic, inflammatory cutaneous disorder that recurs frequently and has negative impacts on the living quality of sufferers.

METHODS: Data from the Inpatient and Outpatient Department medical records at Can Tho dermatology hospital were used to generate a descriptive statistics report on medicines and medical costs for psoriasis therapy in 2019-2021.

RESULTS: The average number of prescription medications varied annually, averaging roughly 0.62±85.4% per prescription. Corticosteroids and calcipotriol were the most commonly recommended drugs for psoriasis. Antihistamines were the most often used medication, with over 12,000 instances among the 28,397 individuals studied. The peak in average per-treatment expenses occurred in 2021 when they fluctuated between US $120 and US $160. In contrast, examination expenses were the most costly, ranging from US $93-$107.

CONCLUSION: The bulk of psoriasis therapy treatments were topical agents, whose quantities rose progressively. Direct examination expenses accounted for the greatest proportion.

PMID:37796471 | DOI:10.7416/ai.2023.2572

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A comparison of COVID-19 incidence rates across six European countries in 2021

Euro Surveill. 2023 Oct;28(40). doi: 10.2807/1560-7917.ES.2023.28.40.2300088.

ABSTRACT

International comparisons of COVID-19 incidence rates have helped gain insights into the characteristics of the disease, benchmark disease impact, shape public health measures and inform potential travel restrictions and border control measures. However, these comparisons may be biased by differences in COVID-19 surveillance systems and approaches to reporting in each country. To better understand these differences and their impact on incidence comparisons, we collected data on surveillance systems from six European countries: Belgium, England, France, Italy, Romania and Sweden. Data collected included: target testing populations, access to testing, case definitions, data entry and management and statistical approaches to incidence calculation. Average testing, incidence and contextual data were also collected. Data represented the surveillance systems as they were in mid-May 2021. Overall, important differences between surveillance systems were detected. Results showed wide variations in testing rates, access to free testing and the types of tests recorded in national databases, which may substantially limit incidence comparability. By systematically including testing information when comparing incidence rates, these comparisons may be greatly improved. New indicators incorporating testing or existing indicators such as death or hospitalisation will be important to improving international comparisons.

PMID:37796443 | DOI:10.2807/1560-7917.ES.2023.28.40.2300088

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Nevin Manimala Statistics

Race and Intention to Breastfeed are the Strongest Predictors of Exclusive Breastfeeding: a Retrospective Study

J Racial Ethn Health Disparities. 2023 Oct 5. doi: 10.1007/s40615-023-01819-8. Online ahead of print.

ABSTRACT

INTRODUCTION: Racial disparities exist in maternal and neonatal care including breastfeeding (BF). The purpose of this study is to assess factors associated with BF success by race with a specific focus on pre-birth BF plan and time duration from birth until initiation of skin-to-skin contact and from birth to the first feed or breastfeed.

METHODS: A database query of our electronic medical records was performed for all patients who had a vaginal delivery that met our study criteria. Demographic information, pre-delivery feeding plan (exclusive BF, exclusive formula, or mixed), time to first feed and first breastfeed, and time to skin-to-skin were compared among different postpartum feeding practices (exclusive BF, exclusive formula, mixed), and compared across race/ethnic groups using ANOVA, Chi-square, and Fisher’s exact statistical tests as appropriate. Logistic regression was used to investigate the independent effect of each variable on exclusive BF.

RESULTS: The study analyzed 12,578 deliveries. There was a significant difference in intended feeding plans among the different racial groups. Approximately 61% of Black patients intended to exclusively BF as compared to 79% of the other groups. Overall, 3994 (32%) patients breastfed exclusively, 872 (7%) exclusively used formula, and 7712 (61%) used a mix of breast and formula. White patients were most likely to exclusively BF (35%) and Black patients were least likely (21%), p < 0.001. Our model found that self-identified race and pre-delivery feeding plan were the strongest predictors of exclusive BF.

CONCLUSIONS: The main findings of this study are that self-identified race and intention to BF are the strongest predictors of exclusive BF. Black patients intend to BF at a significantly lower rate than other racial groups, for reasons not determined by this study, and this affects feeding practice. Our findings are notable because prehospital intention to BF can be modified by outreach, education, and changes to in-hospital practices.

PMID:37796430 | DOI:10.1007/s40615-023-01819-8

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Direct Estimation of Parameters in ODE Models Using WENDy: Weak-Form Estimation of Nonlinear Dynamics

Bull Math Biol. 2023 Oct 5;85(11):110. doi: 10.1007/s11538-023-01208-6.

ABSTRACT

We introduce the Weak-form Estimation of Nonlinear Dynamics (WENDy) method for estimating model parameters for non-linear systems of ODEs. Without relying on any numerical differential equation solvers, WENDy computes accurate estimates and is robust to large (biologically relevant) levels of measurement noise. For low dimensional systems with modest amounts of data, WENDy is competitive with conventional forward solver-based nonlinear least squares methods in terms of speed and accuracy. For both higher dimensional systems and stiff systems, WENDy is typically both faster (often by orders of magnitude) and more accurate than forward solver-based approaches. The core mathematical idea involves an efficient conversion of the strong form representation of a model to its weak form, and then solving a regression problem to perform parameter inference. The core statistical idea rests on the Errors-In-Variables framework, which necessitates the use of the iteratively reweighted least squares algorithm. Further improvements are obtained by using orthonormal test functions, created from a set of [Formula: see text] bump functions of varying support sizes.We demonstrate the high robustness and computational efficiency by applying WENDy to estimate parameters in some common models from population biology, neuroscience, and biochemistry, including logistic growth, Lotka-Volterra, FitzHugh-Nagumo, Hindmarsh-Rose, and a Protein Transduction Benchmark model. Software and code for reproducing the examples is available at https://github.com/MathBioCU/WENDy .

PMID:37796411 | DOI:10.1007/s11538-023-01208-6

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Instance-based learning with prototype reduction for real-time proportional myocontrol: a randomized user study demonstrating accuracy-preserving data reduction for prosthetic embedded systems

Med Biol Eng Comput. 2023 Oct 5. doi: 10.1007/s11517-023-02917-9. Online ahead of print.

ABSTRACT

This work presents the design, implementation and validation of learning techniques based on the kNN scheme for gesture detection in prosthetic control. To cope with high computational demands in instance-based prediction, methods of dataset reduction are evaluated considering real-time determinism to allow for the reliable integration into battery-powered portable devices. The influence of parameterization and varying proportionality schemes is analyzed, utilizing an eight-channel-sEMG armband. Besides offline cross-validation accuracy, success rates in real-time pilot experiments (online target achievement tests) are determined. Based on the assessment of specific dataset reduction techniques’ adequacy for embedded control applications regarding accuracy and timing behaviour, decision surface mapping (DSM) proves itself promising when applying kNN on the reduced set. A randomized, double-blind user study was conducted to evaluate the respective methods (kNN and kNN with DSM-reduction) against ridge regression (RR) and RR with random Fourier features (RR-RFF). The kNN-based methods performed significantly better ([Formula: see text]) than the regression techniques. Between DSM-kNN and kNN, there was no statistically significant difference (significance level 0.05). This is remarkable in consideration of only one sample per class in the reduced set, thus yielding a reduction rate of over 99% while preserving success rate. The same behaviour could be confirmed in an extended user study. With [Formula: see text], which turned out to be an excellent choice, the runtime complexity of both kNN (in every prediction step) as well as DSM-kNN (in the training phase) becomes linear concerning the number of original samples, favouring dependable wearable prosthesis applications.

PMID:37796400 | DOI:10.1007/s11517-023-02917-9

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Nevin Manimala Statistics

Modified multi-Rayleigh model-based statistical analysis of ultrasound envelope for quantification of liver steatosis and fibrosis

J Med Ultrason (2001). 2023 Oct 5. doi: 10.1007/s10396-023-01354-3. Online ahead of print.

ABSTRACT

PURPOSE: Quantitative diagnosis of the degree of fibrosis progression is currently a focus of attention for fatty liver in nonalcoholic steatohepatitis (NASH). However, previous studies have focused on either lipid droplets or fibrotic tissue, and few have reported the evaluation of both in patients whose livers contain adipose and fibrous features. Our aim was to evaluate fibrosis tissue and lipid droplets in the liver.

METHODS: We used an analytical method combining the multi-Rayleigh (MRA) model and a healthy liver structure filter (HLSF) as a technique for statistical analysis of the amplitude envelope to estimate fat and fibrotic volumes in clinical datasets with different degrees of fat and fibrosis progression.

RESULTS: Fat mass was estimated based on the non-MRA fraction corresponding to the signal characteristics of aggregated lipid droplets. Non-MRA fraction has a positive correlation with fat mass and is effective for detecting moderate and severe fatty livers. Progression of fibrosis was estimated using MRA parameters in combination with the HLSF. The proposed method was used to extract non-healthy areas with characteristics of fibrotic tissue. Fibrosis in early fatty liver suggested the possibility of evaluation. On the other hand, fat was identified as a factor that reduced the accuracy of estimating fibrosis progression in moderate and severe fatty livers.

CONCLUSION: The proposed method was used to simultaneously evaluate fat mass and fibrosis progression in early fatty liver, suggesting the possibility of quantitative evaluation for discriminating between lipid droplets and fibrous tissue in the early fatty liver.

PMID:37796397 | DOI:10.1007/s10396-023-01354-3

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Impact of irregular waveforms on data-driven respiratory gated PET/CT images processed using MotionFree algorithm

Ann Nucl Med. 2023 Oct 5. doi: 10.1007/s12149-023-01870-9. Online ahead of print.

ABSTRACT

OBJECTIVES: MotionFree® (AMF) is a data-driven respiratory gating (DDG) algorithm for image processing that has recently been introduced into clinical practice. The present study aimed to verify the accuracy of respiratory waveform and the effects of normal and irregular respiratory motions using AMF with the DDG algorithm.

METHODS: We used a NEMA IEC body phantom comprising six spheres (37-, 28-, 22-, 17-, 13-, and 10 mm diameter) containing 18F. The sphere-to-background ratio was 4:1 (21.2 and 5.3 kBq/mL). We acquired PET/CT images from a stationary or moving phantom placed on a custom-designed motion platform. Respiratory motions were reproduced based on normal (sinusoidal or expiratory-paused waveforms) and irregular (changed amplitude or shifted baseline waveforms) movements. The “width” parameters in AMF were set at 10-60% and extracted data during the expiratory phases of each waveform. We verified the accuracy of the derived waveforms by comparing those input from the motion platform and output determined using AMF. Quantitative accuracy was evaluated as recovery coefficients (RCs), improvement rate, and %change that were calculated based on sphere diameter or width. We evaluated statistical differences in activity concentrations of each sphere between normal and irregular waveforms.

RESULTS: Respiratory waveforms derived from AMF were almost identical to the input waveforms on the motion platform. Although the RCs in each sphere for expiratory-paused and ideal stationary waveforms were almost identical, RCs except the expiratory-paused waveform were lower than those for the stationary waveform. The improvement rate decreased more for the irregular, than the normal waveforms with AMF in smaller spheres. The %change was improved by decreasing the width of waveforms with a shifted baseline. Activity concentrations significantly differed between normal waveforms and those with a shifted baseline in spheres < 28 mm.

CONCLUSIONS: The PET images using AMF with the DDG algorithm provided the precise waveform of respiratory motions and the improvement of quantitative accuracy in the four types of respiratory waveforms. The improvement rate was the most obvious in expiratory-paused waveforms, and the most subtle in those with a shifted baseline. Optimizing the width parameter in irregular waveform will benefit patients who breathe like the waveform with the shifted baseline.

PMID:37796394 | DOI:10.1007/s12149-023-01870-9

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Statin Use and Coronary Artery Calcification: a Systematic Review and Meta-analysis of Observational Studies and Randomized Controlled Trials

Curr Atheroscler Rep. 2023 Oct 5. doi: 10.1007/s11883-023-01151-w. Online ahead of print.

ABSTRACT

PURPOSE OF REVIEW: This review aimed to determine the association between statin use and coronary artery calcification (CAC), as detected by computed tomography in the general population, in previously published observational studies (OSs) and randomized controlled trials (RCTs).

RECENT FINDINGS: A systematic search until February 2022 identified 41 relevant studies, comprising 29 OSs and 12 RCTs. We employed six meta-analysis models, stratifying studies based on design and effect metrics. For cohort studies, the pooled β of the association with CAC quantified by the Agatston score was 0.11 (95% CI = 0.05; 0.16), with an average follow-up time per person (AFTP) of 3.68 years. Cross-sectional studies indicated a pooled odds ratio of 2.11 (95% CI = 1.61; 2.78) for the presence of CAC. In RCTs, the pooled standardized mean differences (SMDs) for CAC, quantified by Agatston score or volume, over and AFTP of 1.25 years were not statistically significant (SMD = – 0.06, 95% CI = – 0.19; 0.06 and SMD = 0.26, 95% CI = – 0.66; 1.19), but significantly different (p-value = 0.04). Meta-regression and subgroup analyses did not show any significant differences in pooled estimates across covariates. The effect of statins on CAC differs across study designs. OSs demonstrate associations between statin use and higher CAC scores and presence while being prone to confounding by indication. Effects from RCTs do not reach statistical significance and vary depending on the quantification method, hampering drawing conclusions. Further investigations are required to address the limitations inherent in each approach.

PMID:37796384 | DOI:10.1007/s11883-023-01151-w