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Nevin Manimala Statistics

Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies

Dermatol Ther (Heidelb). 2024 Mar 23. doi: 10.1007/s13555-024-01136-w. Online ahead of print.

ABSTRACT

INTRODUCTION: The National Psoriasis Foundation (NPF) recommends evaluating patient response to treatment at week 12, with a target response of ≤ 1% body surface area (BSA) affected by plaque psoriasis and an acceptable response of BSA ≤ 3% or ≥ 75% improvement. This post hoc analysis compared the achievement of NPF target and acceptable responses for ixekizumab (IXE) versus other biologics.

METHODS: Outcomes were evaluated at week 12 for patients with moderate-to-severe plaque psoriasis from four head-to-head randomized clinical trials (RCTs; UNCOVER-2, UNCOVER-3, IXORA-R, and IXORA-S) and one real-world prospective observational study (Psoriasis Study of Health Outcomes; PSoHO). RCT patients were treated with IXE or etanercept (ETN; UNCOVER-2/3), guselkumab (GUS; IXORA-R), or ustekinumab (UST; IXORA-S). PSoHO patients were treated with anti-interleukin (IL)-17A biologics (IXE, secukinumab, SEC) and other approved biologics for the treatment of plaque psoriasis. Patients with missing outcomes were imputed as non-responder imputation. For RCT data, statistical comparisons between treatment groups were performed using Fisher’s exact test with no multiplicity adjustments. For real-world data, adjusted comparative analyses were performed using frequentist model averaging (FMA) and reported as odds ratio (OR).

RESULTS: Across the four head-to-head clinical trials analyzed, significantly higher proportions of patients achieved target and acceptable responses at week 12 with IXE versus ETN, GUS, or UST. Likewise, the proportion of PSoHO patients achieving target and acceptable response at week 12 was higher with IXE compared with other individual biologics. Adjusted comparative analyses showed that IXE had significantly greater odds of target and acceptable response at week 12 versus SEC, GUS, risankizumab (RIS), adalimumab (ADA), UST, and tildrakizumab (TILD) and numerically greater odds of target and acceptable response at week 12 versus brodalumab (BROD).

CONCLUSION: Across both clinical studies and real-world settings, more patients treated with IXE achieved NPF target and acceptable responses at week 12 compared with those treated with other biologics.

TRIAL REGISTRATION: UNCOVER-2 (NCT01597245); UNCOVER-3 (NCT01646177); IXORA-R (NCT03573323); IXORA-S (NCT02561806); PSoHO (EUPAS24207).

PMID:38521874 | DOI:10.1007/s13555-024-01136-w

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Nevin Manimala Statistics

A memetic dynamic coral reef optimisation algorithm for simultaneous training, design, and optimisation of artificial neural networks

Sci Rep. 2024 Mar 23;14(1):6961. doi: 10.1038/s41598-024-57654-2.

ABSTRACT

Artificial Neural Networks (ANNs) have been used in a multitude of real-world applications given their predictive capabilities, and algorithms based on gradient descent, such as Backpropagation (BP) and variants, are usually considered for their optimisation. However, these algorithms have been shown to get stuck at local optima, and they require a cautious design of the architecture of the model. This paper proposes a novel memetic training method for simultaneously learning the ANNs structure and weights based on the Coral Reef Optimisation algorithms (CROs), a global-search metaheuristic based on corals’ biology and coral reef formation. Three versions based on the original CRO combined with a Local Search procedure are developed: (1) the basic one, called Memetic CRO; (2) a statistically guided version called Memetic SCRO (M-SCRO) that adjusts the algorithm parameters based on the population fitness; (3) and, finally, an improved Dynamic Statistically-driven version called Memetic Dynamic SCRO (M-DSCRO). M-DSCRO is designed with the idea of improving the M-SCRO version in the evolutionary process, evaluating whether the fitness distribution of the population of ANNs is normal to automatically decide the statistic to be used for assigning the algorithm parameters. Furthermore, all algorithms are adapted to the design of ANNs by means of the most suitable operators. The performance of the different algorithms is evaluated with 40 classification datasets, showing that the proposed M-DSCRO algorithm outperforms the other two versions on most of the datasets. In the final analysis, M-DSCRO is compared against four state-of-the-art methods, demonstrating its superior efficacy in terms of overall accuracy and minority class performance.

PMID:38521859 | DOI:10.1038/s41598-024-57654-2

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Nevin Manimala Statistics

Evaluation of therapeutic use of a combination of pentoxifylline and vitamin E in radiation-induced renal fibrosis

Sci Rep. 2024 Mar 23;14(1):6977. doi: 10.1038/s41598-024-57850-0.

ABSTRACT

Radiation-induced renal fibrosis (RIRF) is a progressive, irreversible condition causing chronic kidney disease. Pentoxifylline (PTX) and vitamin E may mitigate radiation-induced damage and fibrosis. This study assesses their effectiveness. We used four groups, each with six rats: radiation therapy alone (RT-only), radiation therapy plus drug treatment (RT + drug), drug treatment alone (drug-only), and a control group. Rats were monitored for three months, with weight measurements every four weeks. Afterward, rats were analyzed biochemically and histologically, with blood and tissue samples taken for statistical comparison. No significant differences in serum creatinine levels and body weight were observed. RT-only group had more severe kidney tubule effects. Histomorphological, immunohistochemical, and TUNEL analyses showed significant RIRF mitigation in the RT + drug group. Our study highlighted molecular pathways (SMAD, TGF-beta, VEGF) and histological markers (collagens, a-SMA, fibronectin, metalloproteinases) associated with RIRF. PTX and vitamin E reduced ionizing radiation’s impact on renal cells and mitigated radiation-induced kidney fibrosis. Further human studies are needed to confirm these findings.

PMID:38521858 | DOI:10.1038/s41598-024-57850-0

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Nevin Manimala Statistics

Outcome differences by sex in oncology clinical trials

Nat Commun. 2024 Mar 23;15(1):2608. doi: 10.1038/s41467-024-46945-x.

ABSTRACT

Identifying sex differences in outcomes and toxicity between males and females in oncology clinical trials is important and has also been mandated by National Institutes of Health policies. Here we analyze the Trialtrove database, finding that, strikingly, only 472/89,221 oncology clinical trials (0.5%) had curated post-treatment sex comparisons. Among 288 trials with comparisons of survival, outcome, or response, 16% report males having statistically significant better survival outcome or response, while 42% reported significantly better survival outcome or response for females. The strongest differences are in trials of EGFR inhibitors in lung cancer and rituximab in non-Hodgkin’s lymphoma (both favoring females). Among 44 trials with side effect comparisons, more trials report significantly lesser side effects in males (N = 22) than in females (N = 13). Thus, while statistical comparisons between sexes in oncology trials are rarely reported, important differences in outcome and toxicity exist. These considerable outcome and toxicity differences highlight the need for reporting sex differences more thoroughly going forward.

PMID:38521835 | DOI:10.1038/s41467-024-46945-x

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Nevin Manimala Statistics

Birnbaum Saunders distribution for imprecise data: statistical properties, estimation methods, and real life applications

Sci Rep. 2024 Mar 23;14(1):6955. doi: 10.1038/s41598-024-57438-8.

ABSTRACT

A neutrosophic statistic is a random variable and it has a neutrosophic probability distribution. So, in this paper, we introduce the new neutrosophic Birnbaum-Saunders distribution. Some statistical properties are derived, using Mathematica 13.1.1 and R-Studio Software. Two different estimation methods for parameters estimation are introduced for new distribution: maximum likelihood estimation method and Bayesian estimation method. A Monte-Carlo simulation study is used to investigate the behavior of parameters estimates of new distribution, compare the performance of different estimates, and compare between our distribution and the classical version of Birnbaum-Saunders. Finally, study the validity of our new distribution in real life.

PMID:38521823 | DOI:10.1038/s41598-024-57438-8

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Nevin Manimala Statistics

Favorable Outcomes of Liver Transplantation for Hepatopulmonary Syndrome

Transplant Proc. 2024 Mar 22:S0041-1345(24)00165-9. doi: 10.1016/j.transproceed.2024.02.013. Online ahead of print.

ABSTRACT

BACKGROUND: Hepatopulmonary syndrome (HPS) is a pulmonary vascular complication of chronic liver disease, which develops insidiously as a result of chronic liver disease. The prognosis for untreated patients with HPS is extremely poor, and liver transplantation (LT) serves as the only effective means for treating this condition. Here, we performed a retrospective analysis to evaluate the efficacy of LT on the survival and long-term prognosis of patients with HPS.

METHODS: Clinical data, including survival and postoperative efficacy, from patients with HPS from records as obtained over the period from January 1 to December 31, 2022. All records were from a waiting list for LT at the Beijing Friendship Hospital Affiliated with Capital Medical University.

RESULTS: Among the 274 patients on the LT waiting list, 37 were diagnosed with HPS (13.50%) and were enrolled. Survival rates of patients with HPS receiving an LT were greater, whereas a statistically significant difference was obtained between patients with LT vs non-LT with moderate to severe HPS (P = .003). The overall time until death without LT was 4-72 days after their initial HPS diagnosis. Patients with HPS receiving an LT showed a significant improvement in the state of oxygenation after surgery (P = .001).

CONCLUSION: Comprehensive preoperative screening of patients on the waiting list for LT is critical to identify those patients with HPS who would maximally benefit from LT. Survival rates of patients with moderate to severe HPS are significantly increased after LT, a procedure that should be performed as soon as possible in these patients with HPS.

PMID:38521737 | DOI:10.1016/j.transproceed.2024.02.013

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Nevin Manimala Statistics

Leveraging multivariate approaches to advance the science of early-life adversity

Child Abuse Negl. 2024 Mar 22:106754. doi: 10.1016/j.chiabu.2024.106754. Online ahead of print.

ABSTRACT

Since the landmark Adverse Childhood Experiences (ACEs) study, adversity research has expanded to more precisely account for the multifaceted nature of adverse experiences. The complex data structures and interrelated nature of adversity data require robust multivariate statistical methods, and recent methodological and statistical innovations have facilitated advancements in research on childhood adversity. Here, we provide an overview of a subset of multivariate methods that we believe hold particular promise for advancing the field’s understanding of early-life adversity, and discuss how these approaches can be practically applied to explore different research questions. This review covers data-driven or unsupervised approaches (including dimensionality reduction and person-centered clustering/subtype identification) as well as supervised/prediction-based approaches (including linear and tree-based models and neural networks). For each, we highlight studies that have effectively applied the method to provide novel insight into early-life adversity. Taken together, we hope this review serves as a resource to adversity researchers looking to expand upon the cumulative approach described in the original ACEs study, thereby advancing the field’s understanding of the complexity of adversity and related developmental consequences.

PMID:38521731 | DOI:10.1016/j.chiabu.2024.106754

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Nevin Manimala Statistics

Evaluation of Left Ventricular Function in Patients With Severe Aortic Stenosis Utilizing Automated Cardiac Motion Quantitation Techniques

Ultrasound Med Biol. 2024 Mar 22:S0301-5629(24)00119-4. doi: 10.1016/j.ultrasmedbio.2024.03.001. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this study is to explore the patterns of alteration in left ventricular systolic function among patients with severe aortic stenosis (SAS) through the application of automatic myocardial motion quantification (aCMQ) techniques. Furthermore, we seek to ascertain dependable quantitative markers for the assessment of impaired left ventricular function in patients with SAS and an ejection fraction (EF) ≥ 60%.

METHODS: Seventy patients who underwent echocardiography and received a diagnosis of severe aortic stenosis (SAS) in the hospital from November 2021 to August 2022 were selected for the SAS group and categorized into three subgroups based on ejection fraction (EF)-SAS group with EF ≥ 60%, SAS group with EF ranging from 50% to 59%, and SAS group with EF < 50%. Concurrently, 30 healthy individuals were recruited at the hospital during the same timeframe to serve as the control group. Participants from both groups underwent standard transthoracic echocardiography to assess conventional echocardiographic parameters. Dynamic images were examined using automatic myocardial motion quantification (aCMQ) software to derive longitudinal peak strain (LPS) parameters, which were then subjected to statistical analysis.

RESULTS: In comparison to the control group participants, the measurements of ascending aorta diameter (AoD), left atrium diameter (LAD), interventricular septal end diastolic thickness (IVSd), left ventricular posterior wall end diastolic thickness (LVPWd), peak systolic velocity (Vmax), and mean pressure gradient (MPG) were significantly higher in the SAS groups (p < 0.05). When compared to participants in the SAS group with an EF ≥ 60%, the values of IVSd, LVPWd, Vmax, and MPG in the SAS group with EF ranging from 50% to 59% were significantly elevated (p < 0.05). Similarly, left ventricular end-diastolic diameter (LVEDD), the ratio of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e’), and the ratio of early to late diastolic mitral inflow velocities (E/A) in the SAS group with EF < 50% were significantly elevated (p < 0.05). The absolute values of longitudinal peak strain (LPS) in the SAS groups were significantly lower in comparison to those in the control group (p < 0.05). Furthermore, all measurements of left ventricular global longitudinal systolic peak strain (GLPS) showed a positive correlation with MPG, a moderate negative correlation with aortic valve area index (AVAI), and a moderate positive correlation with E/A.

CONCLUSIONS: Patients with SAS and an EF < 50% exhibited the most profound impairment in left ventricular myocardial function. Utilizing the aCMQ technique enables the precise and quantitative evaluation of the severity of impaired left ventricular systolic function in patients within the SAS group with an EF ≥ 60%.

PMID:38521696 | DOI:10.1016/j.ultrasmedbio.2024.03.001

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Nevin Manimala Statistics

The changing pattern of pediatric burns in a territory burn center before and during the COVID-19 pandemic in China: A retrospective study

J Tissue Viability. 2024 Mar 19:S0965-206X(24)00035-4. doi: 10.1016/j.jtv.2024.03.010. Online ahead of print.

ABSTRACT

BACKGROUND: Pediatric burn patients are an essential part of burn populations. However, there is limited publicly available data on the epidemiological impact of COVID-19 on pediatric burns in China.

OBJECTIVE: In this paper, pediatric burn patients admitted to the Department of Burn Surgery of the First Hospital of Jilin University before and during COVID-19 were retrospectively investigated to determine the impact of COVID-19 on pediatric burn inpatients.

METHODS: The information of inpatients from July 2017 to December 2019 (pre-COVID-19 group) and from January 2020 to June 2022 (COVID-19 group) in the Department of Burn Surgery at the First Hospital of Jilin University was retrospectively investigated. Demographic information of patients, length of hospital stay, total body surface area (TBSA) of burn injury, post-injury visit time, comorbidity, surgical methods, etc., were statistically analyzed.

RESULTS: The COVID-19 group included 154 (10.2%) patients, and the pre-COVID-19 group included 335 (19.4%) patients (P<0.001). There were no differences in gender, age, length of hospital stay, or etiology of burns between the two groups. Compared to the pre-COVID-19 group, patients in the pre-COVID-19 group experienced a significant delay in presentation (P<0.001), had a larger TBSA of burn wound (P < 0.001), were more prone to sustaining major burns (P < 0.001), a higher likelihood of undergoing operations (P = 0.03), higher cost (P<0.001) and more complications (P<0.001). Additionally, upper extremities were the most commonly part involved in both groups (P = 0.004), with the lower extremities showed a significant increase to be involved in burn injury during COVID-19 pandemic (P = 0.007). Furthermore, the majority of guardians did not take first aid measures in both groups following burn injury (P = 0.102).

CONCLUSIONS: During the COVID-19 pandemic period, scalds remained the main reason for hospitalization. The number of hospitalized patients has decreased dramatically, while the severity of burns has significantly increased, with a notable delay in hospital visits and an increased occurrence of complications.

PMID:38521680 | DOI:10.1016/j.jtv.2024.03.010

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Nevin Manimala Statistics

Physiologic parameters and radiologic findings can predict pulmonary complications and guide management in traumatic rib fractures

Injury. 2024 Mar 13:111508. doi: 10.1016/j.injury.2024.111508. Online ahead of print.

ABSTRACT

BACKGROUND: Traumatic rib fracture is associated with a high morbidity rate and identifying patients at risk of developing pulmonary complications (PC) can guide management and potentially decrease unnecessary intensive care admissions. Therefore, we sought to assess and compare the utility of a physiologic parameter, vital capacity (VC), with the admission radiologic findings (RibScore) in predicting PC in patients with rib fractures.

METHODS: This is a single-center retrospective review (2015-2018) of all adult (≥18 years) patients admitted to a Level I trauma center with traumatic rib fracture. Exclusion criteria included no CT scan and absence of VC within 48 h of admission. The cohort was stratified into two groups based on presence or absence of PC (pneumonia, unplanned intubation, unplanned transfer to the intensive care unit for a respiratory concern, or the need for a tracheostomy). Multivariable logistic regression models were constructed to identify predictors of PC.

RESULTS: A total of 654 patients met the inclusion criteria of whom 70 % were males. The median age was 51 years and fall (48 %) was the most common type of injury. A total of 36 patients (5.5 %) developed a pulmonary complication. These patients were more likely to be older, had a higher ISS, and were more likely to require a tube thoracostomy placement. On multivariable logistic regression, first VC ≤30 % (AOR: 4.29), day 1 VC ≤30 % (AOR: 3.61), day 2 VC ≤30 % (AOR: 5.54), Δ(Day2-Day1 VC) (AOR: 0.96), and RibScore ≥2 (AOR: 3.19) were significantly associated with PC. On discrimination analysis, day 2 VC had the highest area under the receiver operating characteristic curve (AuROC), 0.81, and was superior to first VC and day 1 VC in predicting PC. There was no statistically significant difference in predicting PC between day 2 VC and RibScore. On multivariable analysis, first VC ≤30 %, day 1 VC ≤30 %, day 2 VC ≤30 %, and admission RibScore ≥2 were associated with prolonged hospital and ICU LOS.

CONCLUSION: VC and RibScore emerged as independent predictors of PC. However, VC was not found to be superior to RibScore in predicting PC. Further prospective research is warranted to validate the findings of this study.

PMID:38521636 | DOI:10.1016/j.injury.2024.111508