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Nevin Manimala Statistics

Hepatic extracellular volume fraction obtained by dual-energy CT: a comparison of 3 and 5 minute delayed phases and correlation with clinical data

Br J Radiol. 2025 Apr 12:tqaf081. doi: 10.1093/bjr/tqaf081. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to compare 3-minute delayed phase images with 5-minute delayed phase images for quantifying hepatic extracellular volume fraction (ECV) using dual-energy computed tomography (CT).

METHODS: Between January 2020 and July 2022, eighty consecutive patients with chronic liver disease (45 men and 35 women, mean age: 69.3 ± 10.4 years) were included in this study cohort. All patients underwent both 3- and 5-minute delayed phase CT scans for assessing focal liver lesions. ECV value was calculated by the iodine densities of the hepatic parenchyma and aorta, and compared between in each phase. Correlations between ECV values in each phase with the albumin-bilirubin (ALBI) score and grade, fibrosis-4 index (Fib-4), and clinical fibrosis stage were statistically analyzed.

RESULTS: No significant difference was found in ECV values between the 3- and 5-minute delayed phase images (p = 0.056). The ratio of ECV values for 3-minute to 5-minute delayed phase images was 0.984 ± 0.078, ranging from 0.85 to 1.16. The ECV calculated on 3- and 5-minute delayed phase images showed strong and moderate correlations with ALBI grade (Spearman’s ρ; 0.763 and 0.724, respectively) and ALBI score (Spearman’s ρ; 0.707 and 0.668, respectively), and also showed moderate correlations with Fib-4 (Spearman’s ρ; 0.548 and 0.543, respectively) and clinical fibrosis stage (Spearman’s ρ; 0.468 and 0.435, respectively).

CONCLUSION: Three-minute delayed phase images were found to be equivalent to 5-minute delayed phase images for the calculation of ECV.

PMID:40221863 | DOI:10.1093/bjr/tqaf081

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Deciphering difficult-to-treat psoriatic arthritis (D2T-PsA): insights from an international survey of patients with psoriatic arthritis

Rheumatology (Oxford). 2025 Apr 12:keaf207. doi: 10.1093/rheumatology/keaf207. Online ahead of print.

ABSTRACT

OBJECTIVES: Psoriatic arthritis (PsA) is a heterogeneous inflammatory disease in which a significant proportion of patients remain refractory to existing therapies. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) initiated a project aimed at unraveling the reasons for treatment failures in PsA, culminating in the establishment of definitions for Difficult-to-Treat PsA (D2T-PsA) and Complex-to-Manage PsA (C2M-PsA). This study explores patient perspectives on treatment-resistant PsA, incorporating a broader patient perspective into the overarching GRAPPA project.

METHODS: Multilingual (10 languages), online survey to explore PsA patients’ perspectives on treatment inefficacies. Developed collaboratively by GRAPPA members and patient research partners. It included sections on demographic data, structured questions about treatment failures, and open-ended questions. Data analysis used descriptive statistics and inductive coding of qualitative responses via Dedoose.

RESULTS: Among 570 respondents, most were female (68.8%) and White (72.6%), with an average PsA diagnosis delay of 4.3 years. Key contributors to D2T- and C2M-PsA were persistent joint pain and psoriasis (65.7%), fatigue (52.8%), and medication side effects (41.7%). Ranked by impact, arthritis was the most debilitating symptom. Quality of life concerns were notable, with sleep impairment and reduced life enjoyment being reported by 66.4%. Language differences emerged; for instance, with Dutch and Italian respondents prioritizing fatigue and daily life impact, respectively.

CONCLUSION: This is the first international study to highlight patient-driven insights in the management of resistant PsA, emphasizing a multidimensional approach that considers biological and psychosocial factors. These insights will inform the ongoing GRAPPA initiative to standardize definitions for treatment-resistant PsA, ultimately improving patient care.

PMID:40221862 | DOI:10.1093/rheumatology/keaf207

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Statistical primer: An introduction into the principles of Bayesian statistical analyses in clinical trials

Eur J Cardiothorac Surg. 2025 Apr 12:ezaf139. doi: 10.1093/ejcts/ezaf139. Online ahead of print.

ABSTRACT

Trials in cardiac surgery are often hampered at the design level by small sample sizes and ethical considerations. The conventional analytical approach, combining frequentist statistics with null hypothesis significance testing, has known limitations and its associated p-values are often misinterpreted, leading to dichotomous conclusions of trial results. The Bayesian statistical framework may overcome these limitations through probabilistic reasoning, and is subsequently introduced in this Primer. The Bayesian framework combines prior beliefs and currently obtained data (the likelihood), resulting in updated beliefs, also known as posterior distributions. These distributions subsequently facilitate probabilistic interpretations. Several previous cardiac surgery trials have been performed under a Bayesian framework and this Primer enhances the understanding of their basic concepts by linking results to graphical presentations. Furthermore, contemporary trials that were initially analysed under a frequentist framework, are re-analysed within a Bayesian framework to demonstrate several interpretative advantages.

PMID:40221858 | DOI:10.1093/ejcts/ezaf139

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Seltoplasmid promotes ulcer healing versus placebo for treating patients with chronic limb-threatening ischemia: HOPE CLTI-2 trial

Mol Ther. 2025 Apr 11:S1525-0016(25)00283-7. doi: 10.1016/j.ymthe.2025.04.009. Online ahead of print.

ABSTRACT

Intramuscular injection of donaperminogene seltoplasmid (recombinant human hepatocyte growth factor plasmids) represents a gene therapy that treat patients with chronic limb-threatening ischemia (CLTI). The HOPE CLTI-2 trial was a Phase 3, multicenter, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of seltoplasmid in patients with Rutherford class 5 CLTI. This study did not require participants to be ineligible for revascularization, allowing enrollment of patients with CLTI caused by either atherosclerosis (ASO) or Buerger’s disease (TAO). The primary endpoint was the complete ulcer healing rate at 6 months. A total of 242 participants (53.3% ASO versus 46.7% TAO) were enrolled, with 161 receiving seltoplasmid and 81 receiving placebo. Complete ulcer healing was achieved in 70 patients in the seltoplasmid group compared to 15 patients in the placebo group, resulting in an adjusted healing rate difference of 26.1% (95% confidence interval [CI]: 15.1-37.0%; P < 0.001). The hazard ratio for healing was 2.31 (95% CI: 1.32-4.05; P = 0.004). The benefits of seltoplasmid on ulcer healing persisted in both TAO and ASO subgroups. Serious adverse events were rare. Our study demonstrated that seltoplasmid significantly improved ulcer healing rates in patients with Rutherford class 5 CLTI compared to placebo.

PMID:40221835 | DOI:10.1016/j.ymthe.2025.04.009

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A robust analysis of alternate methods for estimating blood volume

Perfusion. 2025 Apr 12:2676591251328856. doi: 10.1177/02676591251328856. Online ahead of print.

ABSTRACT

AimThis study evaluates the accuracy of a newly derived blood volume estimation formula based on the Boer equation for lean body mass, comparing its performance against the Nadler, Allen and Lemmens-Bernstein-Brodsky formulas.MethodsBlood volume estimation was evaluated using two datasets: the Retzlaff dataset, based on 78 healthy individuals, and the Allen dataset, derived from 81 subjects, two of European descent, the remainder Chinese ‘medical, nursing and pedagogic students, technicians, clerks and family members’ and one young Chinese physician. The formulas were compared using robust statistical methods, including the Wilcoxon Signed-Rank Test, permutation tests, Bland-Altman analysis, and Proportion Within Range.ResultsAcross all methods, the formula derived from the Boer equation showed the narrowest limits of agreement and smallest variability in most metrics, highlighting its potential as the most accurate and clinically useful tool for blood volume estimation. The Nadler formula also performed well but with slightly larger errors and bias.ConclusionThis study highlights the limitations of the Allen formula and demonstrates the superior performance of the Boer formula, which is derived from lean body mass. While the Allen formula performed well on its original dataset, it showed higher variability and less accuracy on more modern data. Both the Nadler and Boer formulas exhibited greater precision, with the Boer formula showing slightly lower variability. The study emphasizes the importance of using independent data sets for validation and addresses a critical gap in blood volume assessment by using robust techniques for analysis.

PMID:40221826 | DOI:10.1177/02676591251328856

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Safety profile of faricimab: a multi-source pharmacovigilance analysis using FAERS and JADER

BMC Pharmacol Toxicol. 2025 Apr 12;26(1):82. doi: 10.1186/s40360-025-00902-6.

ABSTRACT

BACKGROUND: Faricimab is a bispecific antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), offering a novel therapeutic approach for ocular diseases. However, its long-term safety profile remains under evaluation. This study analyzes its adverse events (AEs) using the U.S. FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER).

METHODS: AEs from FAERS (2004-2024) and JADER (2004-2024) were analyzed using disproportionality algorithms. Subgroup analyses assessed differences by age and sex. AE onset time was also assessed.

RESULTS: Several newly identified adverse events (AEs) were observed, including macular ischemia, keratic precipitates, and optic nerve injury, with strong safety signals detected in both FAERS and JADER. For instance, macular ischemia showed a high association with faricimab use (ROR = 260.46), suggesting a potential risk of retinal circulation impairment. Similarly, keratic precipitates (ROR = 739.65) indicate a notable inflammatory response. All these findings highlight the need for closer monitoring of ocular complications, particularly in high-risk patient groups. The FAERS database mainly reported retinal occlusive vasculitis, ocular vasculitis, and keratic precipitates, while JADER predominantly featured retinal occlusive vasculitis and retinal vascular occlusion. Sex-based differences indicated a higher risk of inflammatory AEs in females (e.g., uveitis and eye inflammation) and a greater incidence of retinal vascular events in males (e.g., retinal vasculitis). Age-related differences showed that older patients (≥65 years) had lower inflammatory AE risks but were more prone to optic nerve damage and retinal atrophy, while younger patients (<65 years) exhibited a higher risk of vitreous hemorrhage and cataracts.

CONCLUSIONS: This study identified previously unreported safety signals, suggesting the need for potential updates to faricimab’s safety labeling. Faricimab’s dual-target mechanism presents unique safety concerns. Clinicians should monitor ocular inflammation and vascular complications, particularly in younger males and Asian patients. Further studies using real-world data are needed to validate these findings.

PMID:40221797 | DOI:10.1186/s40360-025-00902-6

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Effects of taxane-anthracycline and taxane only treatment on cardiac function in breast cancer-a retrospective cohort study

Cardiooncology. 2025 Apr 12;11(1):37. doi: 10.1186/s40959-025-00335-4.

ABSTRACT

INTRODUCTION: Cardiotoxic, anthracycline-based therapies have high value in selected patients with breast cancer. We aimed to describe the effect of anthracycline plus taxane and single taxane chemotherapies on echocardiographic parameters in women with breast cancer.

METHODS: We retrospectively analysed data of 68 women (> 18 years old) treated for breast cancer in 2018-2021 in the Cardiology Outpatient Clinic of Semmelweis University, Department of Internal Medicine and Oncology. Cardiovascular medical history was collected at baseline and transthoracic echocardiography was completed at each visit. Also, we reviewed electronic medical records for other relevant medical information. Measured echocardiography parameters were assigned to five periods (0-14 days, then every half year and beyond day 545) based on the time since the first treatment. Trajectories of ejection fraction and diastolic function associated markers over the follow-up periods were analysed by linear mixed models.

RESULTS: Mean age of the anthracycline plus taxane group was 52.7 ± 14.1 years, of the single taxane group 55.2 ± 13.1 years. The mean anthracycline dose was equivalent to 240 mg/m2 of doxorubicin. Overall pre-existing cardiovascular burden was low. Statistically significant changes were found only in the anthracycline plus taxane group: ejection fraction decreased mildly from 65.5 ± 3.1% at baseline to 62.1 ± 3.2% at 181-365 days (p = 0.007) while deceleration time decreased mildly from 227.9 ± 33.9 msec to 197.4 ± 29.4 msec at 15-180 days (p = 0.028). Both drops were only temporary and values neared baseline values over follow-up (p = NS vs. baseline). Other important determinants of ejection fraction were age and hypertension among the investigated risk factors.

CONCLUSION: Our study confirms the overall safety on cardiac function of both single taxane and anthracycline plus taxane chemotherapy, as we found no changes in echocardiographic parameters associated with single taxane therapy, while anthracycline plus taxane chemotherapy was associated with a temporary and clinically insignificant reduction of ejection fraction and deceleration time over 1.5 years of follow-up. Our study is limited by its retrospective nature and the low number of participants.

PMID:40221795 | DOI:10.1186/s40959-025-00335-4

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Kenya’s 2010 abortion law impacts contraceptive use and fertility rates

Reprod Health. 2025 Apr 12;22(1):52. doi: 10.1186/s12978-025-02002-4.

ABSTRACT

INTRODUCTION: Prior research suggested that liberation of abortion laws in Sub-Saharan Africa (SSA) was associated with fewer abortion complications and deaths. However, few studies have examined the association of abortion law liberalization with modern contraceptive use and fertility rates among women in SSA. In this study, we assessed the impact of Kenya’s 2010 abortion law liberalization on modern contraceptive use and number of recent births (births in the past 5 years ) among women of reproductive age in Kenya.

METHODS: Data from three rounds of the Demographic and Health Surveys (2003-2016) for Kenya, Tanzania and Uganda were used for the analysis. We used the differences-in-differences estimator to assess the impact of the policy change in Kenya using Tanzania and Uganda as the control group. We performed multivariable logistic and Poisson regressions to estimate the adjusted odds ratios (aOR) and adjusted prevalence rate ratios (aPRR) with 95% confidence interval (CI) for modern contraceptive use and number of recent births respectively.

RESULTS: A weighted sample of 117,163 women aged 15-49 years was used for the analyses. Modern contraceptive use increased from 25.4% and 19.4% to 39.1% and 27.2% for the intervention and control groups, respectively, in the post-intervention period. In contrast, the mean number of recent births declined from 0.71 and 0.88 to 0.63 and 0.80 for the intervention and control group, respectively in the post-intervention period. We found that Kenya’s 2010 abortion law liberalization was associated with more people using modern contraception (aOR, 1.22; 95% CI 1.11, 1.34) and fewer recent births (aPRR, 0.95; 95% CI 0.91, 0.98).

CONCLUSION: Our findings suggest that Kenya’s 2010 abortion law was surprisingly associated with higher use of modern contraceptives. Reforming restrictive abortion laws may indirectly improve use of contraceptives in Sub Saharan African countries.

PMID:40221794 | DOI:10.1186/s12978-025-02002-4

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Patient-centered evaluation of integrated care and health equity: evidence from county medical alliances in Henan province

Int J Equity Health. 2025 Apr 12;24(1):101. doi: 10.1186/s12939-025-02468-5.

ABSTRACT

BACKGROUND: Integrated care services have been initiated in China for several years, yet there remains a dearth of substantial evidence and research elucidating the service’s efficacy, particularly in underdeveloped areas. This study aims to address this gap by evaluating the effectiveness of integrated care from the patients’ perspective, thereby offering practical strategies to improve service effectiveness and promote health equity within county medical alliances.

METHODS: The Patient Perceptions of Integrated Care (PPIC) and European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5 L) scales were employed to gather information on patients’ perceptions of integrated care and their self-rated health status. A total of 1093 respondents from two pilot areas were selected for data collection. T-tests and one-way analysis of variance (ANOVA) were recruited, additionally, the study utilized multiple linear regression models to examine the specific impact of various factors on the effectiveness of integrated care services.

RESULTS: The average score for the effectiveness of integrated healthcare services from the patients’ perspective was 67.72 (SD = 14.443, n = 1093). Statistical analysis revealed that as the respondents’ age increased and their self-rated health declined, the PPIC scores showed an upward trend. Regression analysis found that factors such as age, education level, income, health status, and level of healthcare intervention significantly influenced PPIC scores. Overall, there is a trend where respondents with higher health needs tend to have higher perceptions of the service, while those with relatively higher socioeconomic status are more likely to provide lower ratings. Additionally, increasing the frequency and duration of healthcare interventions can improve respondents’ evaluations of the services.

CONCLUSIONS: This study analyzes the effectiveness of integrated services in China’s county-level medical alliance from the patients’ perspective. It finds progress in resource integration and efficiency but identifies limitations in implementation, particularly in balancing equity. Socio-economic factors continue to affect the fairness of service utilization and patient satisfaction. Constraints in finance, human capital, and technology hinder the provision of more targeted services for vulnerable groups. To promote health equity, future services need to focus more on key populations and provide more targeted services, accelerate the integration of information technology, and expand service coverage to address the diverse needs of marginalized communities.

PMID:40221792 | DOI:10.1186/s12939-025-02468-5

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Investigating psychological difference between two genders in mental health after percutaneous coronary intervention for elderly patients with acute coronary syndrome

J Cardiothorac Surg. 2025 Apr 12;20(1):192. doi: 10.1186/s13019-025-03427-5.

ABSTRACT

OBJECTIVE: Psychological factors are closely correlated with coronary heart disease, and gender discrepancies occurs in mental health after percutaneous coronary intervention (PCI) for acute coronary syndrome patients (ACS) are worth studying.

METHODS: This study collected data from patients aged ≥ 60 diagnosed with ACS who underwent PCI treatment within one week of admission to the Cardiovascular Department of Ji’an Central People’s Hospital between June 2021 and December 2022. The study group consisted of 113 female patients, whereas the control group consisted of 121 male patients. Baseline patient data, demography, and laboratory test results were collected. Anxiety and depression were assessed using the Self-rating anxiety scale (SAS) and Self-rating depression scale (SDS) before PCI and at 1, 4, and 12 weeks post-procedure. Descriptive data are presented as x̄±s. Group comparisons for continuous variables were conducted using t-tests, while categorical data were analyzed using chi-square tests. Multiple group comparisons were conducted using analysis of variance.

RESULTS: There were no statistically significant disparities observed in baseline characteristics between these two groups. The assessment of SAS and SDS scores exhibited no statistically significant difference between the two groups before PCI; however, after the procedure, elderly female ACS patients demonstrated notably elevated SAS and SDS scores when contrasted with their elderly male ACS counterparts. Both cohorts manifested their highest SAS and SDS scores before PCI, with a gradual reduction in these scores after the procedure. Elderly female ACS patients experienced a statistically significant reduction in SAS and SDS scores at both 4- and 12 weeks post-PCI compared to their pre-PCI scores.

CONCLUSIONS: Taken together, elderly female ACS patients undergoing PCI are more susceptible to the manifestation of anxiety and depression symptoms compared to their elderly male counterparts.

PMID:40221788 | DOI:10.1186/s13019-025-03427-5