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Nevin Manimala Statistics

Impact of Heel Ulcers on Patients Admitted for Diabetic Foot Disease

Int J Low Extrem Wounds. 2025 Apr 28:15347346251337264. doi: 10.1177/15347346251337264. Online ahead of print.

ABSTRACT

The current study aimed to evaluate the clinical outcomes of patients admitted for diabetic foot ulcers (DFUs) located in the heel. The study is a retrospective observational study including a population of patients admitted for DFUs from April 2024 to September 2024. According to the wound location, patients were divided in two groups: those with heel ulcers and those with forefoot/midfoot ulcers without calcaneal involvement. All patients have been managed through a limb salvage protocol in the respect of international guidelines. The following hospital outcomes were evaluated: minor and major amputation, mortality, length of stay, need for regenerative surgery by using dermal-epidermal graft. Overall, 150 patients were included. The mean age was 70.2 ± 12.2 years, most patients were male (76.0%), had type 2 diabetes (92.7%) with a mean duration of 22.1±13.2 years; 27 (18%) patients had heel ulcers, while 123 (82%) had forefoot/midfoot lesions. Outcomes for patients with heel location and without were: minor amputation (18.5 vs 32.5%, p = 0.1), major amputation (7.4 vs 0.8%, p = 0.02), mortality (0 vs 0.8%, p = 0.5), length of hospital stay (17.5 ± 8.5 vs 14.4 ± 8.7 days, p = 0.08), need for regenerative therapy using dermal-epidermal substitutes (48.1 vs 19.5%, p = 0.003) respectively. In addition, heel ulcer was found to be an independent predictor for major amputation [OR 5.06, CI95% (3.1-11.4), p = 0.02] and length of stay [OR 6 CI95% (3.6-10.9), p = 0.003]. In patients admitted for DFUs, wounds located in the heel were associated to an increased risk of major amputation, need for regenerative therapy and length of stay (even though in the limit of statistical difference) than wounds not located in the heel. These data underline the need for tailored management strategies in this high-risk subgroup of patients.

PMID:40289631 | DOI:10.1177/15347346251337264

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Nevin Manimala Statistics

Partial areas under the curve of the cumulative distribution function as a new composite estimand for randomized clinical trials

Stat Methods Med Res. 2025 Apr 28:9622802251314195. doi: 10.1177/09622802251314195. Online ahead of print.

ABSTRACT

Clinical trials often face the challenge of post-randomization events, such as the initiation of rescue therapy or the premature discontinuation of randomized treatment. Such events, called “intercurrent events” (ICEs) in ICH E9(R1), may influence the estimation and interpretation of treatment effects. According to ICH E9(R1), there are five strategies for handling ICEs. This study focuses on the composite strategy, which incorporates ICEs in the outcome of interest and defines the treatment effects using composite endpoints that combine the measured continuous variables and ICEs. An advantage of this strategy is that it avoids the occurrence of missing data because they are defined as part of the outcome of interest. In this study, we propose a new composite estimand: the difference in the partial areas under the curves (pAUCs) of the cumulative distribution function. While the pAUC is closely related to the trimmed mean approach proposed by Permutt and Li, it offers the advantage of allowing pre-specification of the cutoff value for a “good” response based on clinical considerations. This ensures that the pAUC can be calculated irrespective of the proportion of ICEs. We describe the causal interpretation of our method and its relationship with two other strategies (treatment policy and hypothetical strategies) using a potential outcome framework. We present simulation results in which our method performs reasonably well compared to several existing approaches in terms of type I error, power, and the proportion of undefined test statistics.

PMID:40289630 | DOI:10.1177/09622802251314195

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Nevin Manimala Statistics

Perceived stress and performance of daily activities among emergency healthcare workers during the COVID-19 pandemic

Work. 2025 Apr 28:10519815251331802. doi: 10.1177/10519815251331802. Online ahead of print.

ABSTRACT

BackgroundDuring the COVID-19 pandemic, healthcare workers were exposed to intense stress in the emergency departments and sudden changes in their daily lives.ObjectiveThe study aimed to investigate the impact of the pandemic on performance and participation in the activities of daily living, personal lives, and overall well-being of the healthcare workers in an emergency department.MethodsSeventy-eight people working in an emergency department of a university hospital (100% of those eligible) participated in the study during June-July 2022. A self-report survey, cross-sectional design was used to collect data. Participants completed the Perceived Stress Scale-10 (PSS) and the Canadian Occupational Performance Measure (COPM). Independent sample t-tests, Pearson correlation, and multiple regression analysis were used for statistical analysis.ResultsThere was a significant negative correlation between PSS and COPM Performance (r = -0.524) as well as between PSS and COPM Satisfaction (r = -0.508), indicating that higher levels of stress were associated with lower performance and satisfaction. In addition, work-related factors, including working experience, daily working hours, and time available for rest at work, were significantly associated with PSS, COPM Performance, and Satisfaction (p < 0.05). The strongest multivariate associations (p = 0.001) were found between lacking time to rest at work and PSS (direct) and COPM Performance and Satisfaction (inverse).ConclusionThe stress experienced by emergency healthcare workers during COVID-19 negatively impacted their performance, daily activities, personal lives, and well-being. A potential implication is that policy-makers addressing work-related factors and implementing regulations could improve the well-being of these workers in their professional practices.

PMID:40289629 | DOI:10.1177/10519815251331802

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Nevin Manimala Statistics

Towards greener prescribing? Swedish general practitioners’ support for policies to reduce pharmaceutical pollution

Br J Clin Pharmacol. 2025 Apr 27. doi: 10.1002/bcp.70066. Online ahead of print.

ABSTRACT

AIMS: Prescribing pharmaceuticals is essential to improve health, but it also has substantial environmental impact. This study investigated the extent to which Swedish general practitioners (GPs) are willing to integrate environmental aspects into treatment decisions and their opinions on policies to reduce pharmaceutical pollution.

METHODS: A questionnaire assessing environmental considerations in prescribing was developed and distributed to 1233 Swedish GPs and physicians in training (response rate: 22%) between September 2023 and June 2024. It included 3 patient cases to assess trade-offs between therapeutic effect and environmental impact of pharmaceuticals used for pain management, blood pressure reduction, and contraception. Questions about attitudes to policies to reduce the environmental impact of pharmaceuticals were also included. Data were analysed using descriptive and inferential statistics.

RESULTS: Most respondents were willing to prescribe a less effective pharmaceutical if it was environmentally preferable, 77% for pain management and blood pressure reduction, and 50% for contraception. Environmental impact was ranked as the least important factor in prescribing decisions when compared to cost, regional treatment guidelines, dosage intervals, and user-friendliness. A total of 68% of respondents agreed that physicians should consider environmental aspects when prescribing, however only a few often searched for environmental information when prescribing. Policies directed towards other stakeholders, such as authorities and the pharmaceutical industry, received substantial support.

CONCLUSION: Swedish GPs are willing to consider environmental factors when prescribing. However, other factors are more often considered and GPs attribute higher responsibility to other actors. Improving access to environmental information about pharmaceuticals could support greener prescribing.

PMID:40289270 | DOI:10.1002/bcp.70066

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Nevin Manimala Statistics

Propafenone- vs. amiodarone-associated adverse cardiac outcomes in patients with atrial fibrillation and heart failure

Br J Clin Pharmacol. 2025 Apr 27. doi: 10.1002/bcp.70068. Online ahead of print.

ABSTRACT

AIMS: Clinical trials have shown an increased risk of death in patients with recent myocardial infarction who received antiarrhythmic drugs such as flecainide, encainide or moricizine, especially in the presence of associated structural heart disease such as cardiac dysfunction. This study aimed to evaluate the safety outcomes of propafenone use in atrial fibrillation patients with heart failure when compared to those of amiodarone use.

METHODS: This population-based cohort study used the National Health Insurance Research Database in Taiwan. Eligible patients were those who had atrial fibrillation or atrial flutter diagnosis, had heart failure diagnosis, and first received propafenone or amiodarone between 2002 and 2018. The primary endpoints were death due to arrhythmia and the composite proarrhythmic outcome, which consisted of sudden cardiac arrest, arrhythmic death, ventricular arrhythmia and implantation of defibrillator.

RESULTS: After propensity score matching, the study cohort consisted of 7235 propafenone and 14 470 amiodarone users. Compared to amiodarone, propafenone was associated with significantly lower risk of the composite proarrhythmic outcome (adjusted hazard ratio: 0.52; 95% confidence interval: 0.42-0.64; P < .001). Propafenone users also had lower risk of death owing to arrhythmia compared to amiodarone users (adjusted hazard ratio: 0.22; 95% confidence interval: 0.08-0.65; P = .006). Subgroup analysis and sensitivity analysis showed similar trends, favouring propafenone.

CONCLUSION: Propafenone was not significantly associated with increased risk of proarrhythmia and mortality when compared to amiodarone in atrial fibrillation patients with heart failure in contemporary real-world settings. Prospective studies are needed to determine whether propafenone should definitely be avoided in these patients.

PMID:40289259 | DOI:10.1002/bcp.70068

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Nevin Manimala Statistics

Racial and ethnic differences in HPV-related cancer incidence in the United States, 2001-2020

J Natl Cancer Inst. 2025 Apr 26:djaf107. doi: 10.1093/jnci/djaf107. Online ahead of print.

ABSTRACT

BACKGROUND: Human papillomavirus (HPV) causes cervical cancer and a proportion of oropharyngeal, vulvar, vaginal, penile, and anal cancers. Evaluating racial and ethnic heterogeneity by anatomic site will identify populations with the highest cancer incidence rates (IRs) and help to optimize available prevention strategies.

METHODS: Using the 2001-2020 US Cancer Statistics database, we estimated age-standardized IRs cervical carcinoma, oropharyngeal, anal, vaginal, vulvar, and penile squamous cell carcinomas (SCCs) by race and ethnicity. We examined changes over time by comparing IRs in 2016-2020 with 2001-2005.

RESULTS: Between 2001-2020, 750,897 HPV-related cancers occurred among 6,168,715,419 total person-years, with 61% (n = 455,475) in females. Among females, the highest IRs of oropharyngeal (1.6/100,000 person-years), vulvar (2.3/100,000 person-years), and anal (2.1/100,000 person-years) SCC were among White females. The highest IR for vaginal SCC (0.6/100,000 person-years) was among Black females and for cervical carcinoma (10.0/100,000 person-years) among Hispanic females. Among males, the highest IR for oropharyngeal SCC (8.0/100,000 person-years) was among White males, penile SCC (1.3/100,000 person-years) among Hispanic males, and anal SCC (1.5/100,000 person-years) among Black males. From 2001-2005 to 2016-2020, for most racial and ethnic groups, both in terms of absolute incidence, and proportion of the total HPV-related cancer burden, cervical carcinoma and vaginal SCC rates decreased, vulvar and anal SCC increased, and there was no clear pattern in oropharyngeal and penile SCC rates.

CONCLUSION: For all cancer types, there were disparate racial and ethnic patterns by anatomic site likely caused by a constellation of factors, including access to preventive care and site-specific HPV prevalence.

PMID:40289254 | DOI:10.1093/jnci/djaf107

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Nevin Manimala Statistics

Effect of NME2 and SAMHD1 genetic polymorphisms involved in Ara-C metabolism on the response to induction chemotherapy in adult acute myeloid leukemia

J Egypt Natl Canc Inst. 2025 Apr 28;37(1):14. doi: 10.1186/s43046-025-00272-4.

ABSTRACT

BACKGROUND: Cytarabine is a prodrug which is activated to cytarabine triphosphate (Ara-CTP) through a series of phosphorylation steps. For considerable leukemic cell death, high level of Ara-CTP is required. Sterile alpha motif and histidine-aspartate domain-containing protein 1 (SAMHD1) and Nucleotide diphosphate kinase-2 (NME2) are genes involved in Ara-CTP metabolism. To best of our knowledge, there are no similar studies focused on the association of different polymorphisms involved Ara-C metabolism on the response to induction chemotherapy among adult AML Egyptian patients. Therefore, the aim of this study was to determine the effect of SAMHD1 rs28372906 and NME2 rs3744660 polymorphisms on AML complete remission rate (CR), overall survival (OS), and disease-free survival (DFS) among adult AML Egyptian patients, after Ara-C based induction therapy.

METHODS: This study was a retrospective conducted at the National Cancer Institute, Cairo University, Egypt. The patient group included 136 adult patients with newly diagnosed AML, while the control group included 48 healthy subjects. The clinical history of all studied patients was collected from patient records. Patients and controls were genotyped for NEM2 (rs3744660) and SAMHD1 (rs28372906) by using Taq Man Genotyping assay and Taq Man genotyping master mix (REF: 4,371,353, Applied Biosystems, USA). Real-time PCR assay was performed on Thermo Fisher Quant Studio™ 3. The Statistical Package for Social Science version 21.0 was used to analyze our data.

RESULTS: Regarding the SAMHD1 (rs28372906) polymorphism, we did not find any genotype variations between patient, and control groups, where all of them were AA genotype. Regarding NME2 (rs3744660) polymorphism the statistical analysis reported significant association between D28 blasts and OS (P-value = 0.043), while the remaining initial patient characteristics and response to induction were not associated with OS.

CONCLUSION: CR, DFS, and OS were not significantly associated to SAMHD1 rs28372906 and NME2 rs3744660 polymorphisms.

PMID:40289230 | DOI:10.1186/s43046-025-00272-4

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Nevin Manimala Statistics

Graphene-PbS quantum dot hybrid photodetectors from 200 mm wafer scale processing

Sci Rep. 2025 Apr 27;15(1):14706. doi: 10.1038/s41598-025-96207-z.

ABSTRACT

A 200 mm processing platform for the large-scale production of graphene field-effect transistor-quantum dot (GFET-QD) hybrid photodetectors is demonstrated. A comprehensive statistical analysis of the electrical data revealed a high yield (96%) and low variation in the 200 mm scale fabrication. The GFET-QD devices deliver responsivities of 105 to 106 V/W in the wavelength range from 400 to 1800 nm with a response time of 10 ms. The spectral sensitivity compares well to that obtained via similar GFET-QD photodetectors. The device concept enables gate-tunable suppression or enhancement of the photovoltage, which may be exploited for electric shutter operation by toggling between the signal capture and shutter states. The devices show good stability over a wide operation range. Furthermore, an integration solution with complementary metal-oxide-semiconductor technology is presented to realize image-sensor-array chips and a proof-of-concept image system. This work demonstrates the potential for the volume manufacture of infrared photodetectors for a wide range of imaging applications.

PMID:40289227 | DOI:10.1038/s41598-025-96207-z

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Nevin Manimala Statistics

Social vulnerability index enhances FRAX prediction of hip fractures in fall patients

Sci Rep. 2025 Apr 27;15(1):14704. doi: 10.1038/s41598-025-99373-2.

ABSTRACT

The Fracture Risk Assessment Tool (FRAX), widely used for predicting the 10-year likelihood of hip fractures, does not incorporate factors like prior falls and sociodemographic characteristics, notably the Social Vulnerability Index (SVI). Recognizing these limitations, we aim to evaluate the predictive accuracy of FRAX by integrating fall frequency, fall energy, and SVI into the model for assessing the risk of fall-induced hip fractures. A retrospective case-control study was conducted, and patients aged ≥ 40 years with a documented diagnosis of a fall-induced hip fracture were age-matched with controls with a history of falls without an associated hip fracture. Basic demographic data, along with information about the number of prior falls and the energy of the current falls, were collected. The FRAX and SVI were calculated accordingly. Logistic regression analysis was employed to identify significant predictors. The performance of the models was evaluated and reported using appropriate metrics. Baseline characteristics of the dataset were presented as medians with interquartile ranges (IQR) or as percentages, where applicable. The significance of the identified variables was quantified using Odds Ratio (OR) along with their 95% Confidence Interval (CI). A p-value threshold of 0.05 was set for statistical significance. A total of 261 patients per group were included with a median age of 74 (IQR 67-80) and 72 (IQR 62-83) years. The FRAX score was significantly associated with the likelihood of experiencing a fall-induced hip fracture, as indicated by an OR of 1.06 (CI: 1.03-1.09). Participants with a one-time history of falls had an OR of 1.58 (CI: 1.02-2.37), compared to 1.84 (CI: 1.09-3.1) for those with multiple falls. The White participants, along with the Housing Type and Transportation domain of the SVI, also demonstrated to play a role (OR = 2.85 (CI: 1.56-5.2) and OR = 0.3 (CI: 0.12-0.8), respectively). This study underscored the significance of factors such as fall frequency, SVI, and race in predicting fall-induced hip fractures. It also highlighted the need for further refinement of the FRAX tool. We recommend that future research should be focused on validating the impact of these sociodemographic and fall characteristics on a broader scale, along with exploring the implications of clinical surrogates related to falls.

PMID:40289226 | DOI:10.1038/s41598-025-99373-2

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Nevin Manimala Statistics

Deciphering hygromycin B biosynthetic pathway and D-optimal design for production optimization

World J Microbiol Biotechnol. 2025 Apr 28;41(5):155. doi: 10.1007/s11274-025-04364-0.

ABSTRACT

Hygromycin B (HYG-B) is a 5-glycosylated 2-dexoystreptamine- aminoglycoside antibiotic-(2DOS-AGA) produced by Streptomyces hygroscopicus subspecies hygroscopicus NRRL ISP-5578 with broad-spectrum activity against many pathogenic bacteria, fungi and helminths. In the literature, limited studies are concerned with the biosynthetic pathway and different cultural conditions affecting the production of HYG-B. This study aimed to optimize key environmental conditions influencing its production as one-factor-at-a-time (OFAT) and as a statistical model of response surface D-optimal design (DOD). Moreover, the biosynthetic pathway of HYG-B in light of the identified genes/proteins of the HYG-B gene cluster was proposed and elucidated. The effect of culture media composition and incubation time were studied OFAT, and the results showed that both culture media 6 (CM6) and CM4 gave the highest specific productivity, 5.88 and 3.99 µg/mg, respectively, and 7 days as incubation time. So, using CM6 and 7 days incubation resulted in a sevenfold increase (190 µg/mL) compared to the original unoptimized condition (CM1 and 6 days incubation; 26.9 µg/mL). Three important factors-initial pH, incubation temperature, and agitation-were tested using a DOD quadratic model generating 20 experimental runs. An initial pH of 6.4, an incubation temperature, of 28 ℃, and agitation. of 295 rpm were predicted and experimentally verified, resulting in a 13-fold increase (371.5 µg/mL) compared to the unoptimized condition and a sevenfold increase compared to that obtained as OFAT. In conclusion, DOD design is an efficient tool for optimizing HYG-B. However, the optimized conditions should be scaled up in a bioreactor for industrial production of HYG-B by S. hygroscopicus NRRL ISP-5578.

PMID:40289225 | DOI:10.1007/s11274-025-04364-0