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Nevin Manimala Statistics

Fetal size, gestational age, and cognitive performance at 5 years in term-born children: Four national cohorts’ study

Int J Gynaecol Obstet. 2025 Nov 17. doi: 10.1002/ijgo.70671. Online ahead of print.

ABSTRACT

OBJECTIVE: Fetal size and gestational age are essential factors to consider when determining the timing of delivery between mothers and obstetricians in term pregnancies. Previous studies have shown that both fetal size and gestational age have associations with cognitive or academic outcomes. This study aimed to determine whether the association between gestational age (37-41 weeks) and child intelligence is moderated by fetal size in term-born children.

METHODS: Data were harmonized for four national cohorts in the USA, UK, Ireland, and Australia. Predictors included fetal size and gestational age. Fetal size was calculated using Fenton’s chart and grouped into three categories: Large for gestational age (LGA) (>90th percentile), appropriate for gestational age (AGA) (10th to 90th percentile), and small for gestational age (SGA) (<10th percentile). The outcome was intelligence quotient (IQ) scores at age 5 years. Linear models, contrast analyses, and point plots were employed.

RESULTS: In total, 30 035 term-born participants were included in the analysis. Overall, being born before 41 weeks and being born with SGA (but not LGA) were both negatively associated with IQ. No statistically significant interactions between fetal size category and gestational age at term were found. At each gestation from 37 to 41 weeks, being born SGA (but not LGA) was associated with lower IQ when compared to AGA. A small but clinically significant reduction in IQ (i.e., 0.23 IQ Z-score, equivalent to a 3.45 IQ difference) was found in SGA-born children who were born at 37 weeks compared to 41 weeks.

CONCLUSION: The association between gestation and child IQ at age 5 was not moderated by fetal size in term-born children. Regardless of gestational age at term, SGA (but not LGA) is consistently and unfavorably associated with poorer cognitive outcomes. The IQ at age 5 was only clinically meaningfully decreased in SGA children born at 37 weeks.

PMID:41243845 | DOI:10.1002/ijgo.70671

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Nevin Manimala Statistics

Woman-centeredness of family planning care and associated factors in a semi-urban health district in West Cameroon

Int J Gynaecol Obstet. 2025 Nov 17. doi: 10.1002/ijgo.70654. Online ahead of print.

ABSTRACT

OBJECTIVE: To measure the woman-centeredness of family planning (FP) care and determine its correlates in West Cameroon.

METHODS: We conducted a cross-sectional analytical study from August to November 2024 in the Mifi Health District (MHD). We included women receiving FP care in all the public health facilities. We collected data were using the person-centered FP care scale (PCFPS). Descriptive and inferential statistics were computed with R software. Respondents’ characteristics were summarized, and woman-centeredness scores computed using the PCFPS guide. We used the cutoff threshold technique to distinguish high and low scores. Bivariate and multivariate linear regressions were conducted to determine the correlates of woman-centeredness of FP care. Regression coefficients with their 95% confidence intervals (CIs) were computed with a significance threshold of 5%.

RESULTS: The median (range) woman-centeredness score for the 179 respondents was 73.33% (12.22-88.88). Specifically, the median (range) score (76.38% [8.33-91.66]) for woman’s respect and autonomy was higher than that (61.11% [5.55-100]) for health facility environment. The FP care woman-centeredness score at the district hospital was seven-point higher than in first-level primary healthcare facilities (a.Coefficient: 7.33; 95% CI: 1.11-13.56; P = 0.02). Likewise the woman-centeredness score of FP care for women with a monthly income ≤100 USD was significantly lower than for women earning >300 USD monthly (a.Coefficient: -6.98; 95% CI: -12.96 to -1.01; P = 0.02).

CONCLUSION: FP care in the MHD was highly women centered. However, FP care was less likely to be woman-centered for low-income women and for those attending first-level primary health care facilities.

PMID:41243834 | DOI:10.1002/ijgo.70654

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Nevin Manimala Statistics

A Real-World Disproportionality Analysis of Avacopan in Anti-Neutrophil Cytoplasmic Antibodies Associated Vasculitis: Insights From FDA Adverse Event Reporting System

Pharmacol Res Perspect. 2025 Dec;13(6):e70194. doi: 10.1002/prp2.70194.

ABSTRACT

Avacopan, an oral C5a receptor antagonist approved for treating anti-neutrophil cytoplasmic antibodies (ANCA) associated vasculitis, has established efficacy and short-term safety from clinical trials, but its post-marketing adverse events (AEs) in real-world settings require further characterization. We conducted a retrospective analysis of the U.S. FDA Adverse Event Reporting System (FAERS) database from Q1 2022 to Q1 2025. After data cleaning, Avacopan-related AEs were extracted, coded using MedDRA terminology, and analyzed via four signal detection methods; subgroup analyses by age, sex, and reporter type were performed. Among 3529 reports, significant disproportionality signals emerged for known AEs (e.g., hepatobiliary disorders, serious infections) and unexpected signals including venous thromboembolism, cholestatic jaundice, and alopecia. Most AEs occurred within the first 30 days of treatment, with variations observed by age and sex. This study provides the first FAERS-based pharmacovigilance assessment of Avacopan, confirming known risks and identifying novel post-approval safety signals, underscoring the need for close early-treatment monitoring and personalized strategies. Further research is warranted to confirm emerging signals and explore their mechanisms.

PMID:41243819 | DOI:10.1002/prp2.70194

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Nevin Manimala Statistics

Exposure to Suaahara II Interventions and Knowledge of Maternal and Child Nutrition and Health Among Mothers, Grandmothers, and Male Household Heads: An Association Study in Nepal

Matern Child Nutr. 2026 Mar;22(1):e70134. doi: 10.1111/mcn.70134.

ABSTRACT

Suaahara was a USAID-funded multi-sectoral integrated nutrition program that aimed to improve the nutritional status of children under the age of five and their mothers in Nepal. The program included multiple interventions targeted to mothers and children, as well as other caregivers. Caregiver knowledge of optimal nutrition and health practices among household members is an important driver of healthy child and maternal nutrition behaviors. This study investigates the associations between exposure to Suaahara interventions and knowledge of maternal and child nutrition and health practices among mothers (n = , grandmothers (n = , and male household heads (n = . Linear and logistic regression models were conducted using data from the endline survey of Suaahara’s impact evaluation conducted in 2022. Exposure to Suaahara was associated with mothers’ and grandmothers’ knowledge of ideal child and maternal health and nutrition practices. Compared to those unexposed to Suuahara, mothers and grandmothers who were exposed to Suaahara interventions had 2.09 and 2.23 times higher odds respectively (p = 0.001; p = < 0.001), respectively, of having correct knowledge of exclusive breastfeeding, and 1.48 and 1.47 times higher odds respectively, of having correct knowledge of age of introduction of all types of complementary foods (p = 0.005; p = 0.070). Furthermore, exposed mothers had 1.49 times higher odds (p = 0.021) and exposed grandmothers had 1.42 times higher odds (p = 0.09) of knowing that young children should be fed more during illness. Male household heads who were exposed had 1.71 times higher odds of knowing that colostrum should be given to children immediately after birth (p = 0.027). Exposure to Suaahara was also associated with mothers’ and grandmothers’ knowledge of ideal maternal health and nutrition practices. Exposed mothers had 1.64 times higher odds (p = 0.011) and grandmothers had 2.92 times higher odds (p < 0.001) of knowing that mothers should take iron and folic acid supplementation for 180 days during pregnancy (p = 0.011; p = < 0.001). Exposed grandmothers had 1.87 times higher odds of having correct knowledge that mothers should have at least 4 antenatal care visits (p = 0.012). Exposed mothers and grandmothers had 1.88 and 1.90 times higher odds of having correct knowledge that mothers need at least 3 postnatal care visits (p = 0.002; p = 0.051). This study highlights multiple positive associations between exposure to Suaahara and knowledge of mothers and grandmothers around maternal and child health and nutrition practices. This effect was less pronounced in male household heads suggesting that tailored interventions are necessary to improve knowledge of appropriate child and maternal nutrition and health practices in this group. Future research should consider collecting data from multiple household members to better understand the paths between their knowledge and impact on maternal and child health and nutrition practices.

PMID:41243799 | DOI:10.1111/mcn.70134

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Nevin Manimala Statistics

Coral Bleaching: The Equatorial-Refugia Hypothesis

Glob Chang Biol. 2025 Nov;31(11):e70594. doi: 10.1111/gcb.70594.

ABSTRACT

The rising threat of marine heatwaves has led to numerous predictions that coral reefs, especially those near the Equator, will be severely degraded by the end of the current century. Yet, environmental conditions near the Equator may regionally moderate coral bleaching by reducing thermal stress during marine heatwaves. We deployed a Bayesian spatio-temporal model over Earth to examine which environmental conditions may characterize marine-heatwave refugia for coral reefs by testing the relationship between the severity of coral bleaching and a suite of temperature, hydrodynamic, topographic, atmospheric, and biological variables. The model considered the severity of coral bleaching as the proportion of bleached hard corals during 30,266 coral-reef surveys conducted at 8728 sites, at depths of up to 20 m, and located between 35° north and south of the Equator across 81 countries, from 2002 to 2020. Except for the eastern Pacific Ocean, the severity of coral bleaching during marine heatwaves was lower on equatorial reefs than on higher-latitude reefs, suggesting that marine-heatwave refugia for corals have been concentrated in the equatorial Coral Triangle region. Indeed, equatorial reefs in the Coral Triangle were, on average, exposed to the weakest marine heatwaves, potentially because they were shielded from extreme insolation by frequent cloud coverage in the Intertropical Convergence Zone. Coral bleaching may also be moderated during marine heatwaves on reefs that experience high wave energy, high current velocity, high cloud frequency, or turbidity. Coral bleaching was also less severe on reefs that historically endured frequent heatwaves than on reefs that were naïve to thermal stress. Based on modern and historical responses of coral reefs to acute thermal stress, we hypothesize that many equatorial reefs will continue to serve as marine-heatwave refugia for corals.

PMID:41243784 | DOI:10.1111/gcb.70594

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Nevin Manimala Statistics

Performance evaluation of the new Roche Lupus Screen and Lupus Confirm Russell’s viper venom reagents on the cobas t 711 analyzer for lupus anticoagulant detection

Ann Biol Clin (Paris). 2025 Nov 17;83(6):0. doi: 10.1684/abc.2025.2003. Online ahead of print.

ABSTRACT

Current guidelines recommend using at least two different assays for lupus anticoagulant (LA) detection. One such assay is the dilute Russell’s viper venom time (dRVVT). This study aimed to evaluate the analytical performance of the Lupus Screen and Lupus Confirm dRVVT reagents (Roche Diagnostics) on the cobas t 711 analyzer and to compare their diagnostic performance against an established reagent pair (LA1/LA2, Siemens) using the Sysmex CN-6000 analyzer (Sysmex Corporation) for LA detection. Repeatability was assessed by testing lyophilized quality control plasmas 20 times in a single run. Reproducibility was evaluated over at least five days with duplicate testing. A total of 101 anonymized patient samples were analyzed with both Roche and Siemens reagents on their respective platforms. Statistical analysis was performed using GraphPad Prism software version 9.5.0 (GraphPad Software, San Diego, CA, USA). Diagnostic performance was assessed via positive percentage agreement (PPA), negative percentage agreement (NPA), and overall rate of agreement (ORA). The within-run and between-run CVs were < 2%. Results obtained with the Roche and Siemens reagents were strongly correlated (r = 0.950, 0.923, and 0.877 for screen, confirm, and normalized screen/confirm ratios, respectively; all p < 0.001) and bias were acceptable. Assuming Siemens reagents as reference, PPA, NPA, and ORA were 92.42%, 100%, and 95.05%, respectively. The Lupus Screen and Lupus Confirm reagents demonstrated excellent analytical and diagnostic performance and are well-suited for LA detection in non-anticoagulated patient samples.

PMID:41243783 | DOI:10.1684/abc.2025.2003

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Nevin Manimala Statistics

Physical, Psychological, and Behavioral Symptoms of Premenstrual Syndrome in Relation to Body Size and Shape

Am J Hum Biol. 2025 Nov;37(11):e70169. doi: 10.1002/ajhb.70169.

ABSTRACT

INTRODUCTION: This study aimed to evaluate potential relationships between the frequency of physical, and psychological or behavioral symptoms of premenstrual syndrome (PMS) in relation to body mass index (BMI) and body shapes in young women.

METHODS: In total, 22 of the most common PMS symptoms were assessed using a questionnaire, as well as self-reported height, weight, and body shape (using five silhouette types). A total of 6697 women aged 18-30 was included in the final statistical analysis. Symptom frequencies were measured using a 5-point Likert scale, and the mean frequency of occurrence (MFO) was calculated for all symptoms. Statistical analyses included analysis of variance (ANOVA), univariate logistic regression, and stepwise regression.

RESULTS: PMS symptom prevalence ranged from 61.0% to 97.2%. Overall, MFO of all physical PMS symptoms (M ± SD = 3.12 ± 0.75) was lower than the MFO of all psychological and behavioral symptoms (M ± SD = 3.29 ± 0.96; p < 0.001). Women with overweight or obesity, also those with an apple-shaped body, reported the highest symptom frequencies (MFO = 3.20-3.35), while underweight and rectangular-shaped women had the lowest MFO (2.98-3.25; p < 0.001). Stepwise analysis showed BMI and body shape were more strongly associated with physical symptoms than psychological or behavioral ones.

CONCLUSIONS: These results highlight the importance of body size and shape in understanding individual differences in PMS symptoms, suggesting that higher BMI and an apple-shaped body are more associated with PMS symptoms. Therefore, special attention should be paid to women with this body type, and they should be examined more thoroughly in order to take preventive measures in a timely manner.

PMID:41243766 | DOI:10.1002/ajhb.70169

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Nevin Manimala Statistics

Statistical Consideration for Event-Free Survival With Cure Rate in Acute Myeloid Leukemia Studies

Pharm Stat. 2025 Nov-Dec;24(6):e70052. doi: 10.1002/pst.70052.

ABSTRACT

In many acute myeloid leukemia (AML) studies, event-free survival (EFS) has been accepted as a primary efficacy endpoint. In those studies, the patients who do not achieve complete remission (CR) in the induction period are regarded as induction treatment failure (ITF). The recent FDA guidance on AML (2022) has clearly specified ITF as the event at Day 1 of randomization, considering the variability of length of individual induction treatment periods among studies. Xu et al. (2021) suggested decomposing the log-rank test statistic into the ITF portion, and the Non-ITF portion that is defined as the patients who achieved CR, and assumed proportional hazards for the Non-ITF portion. However, especially in the newly diagnosed AML study, there is some indication of the cured patients who achieve CR during the induction period. As a result, Non-zero ITF rates and cured patients invalidate the proportional hazards assumption and therefore, the conventional power calculation based on the number of events may be problematic in this setting. Our research follows the same decomposition of the log-rank test statistic as Xu et al. (2021) and suggests a new sample size calculation method accounting for the presence of both ITF and cured patients. The result shows that the analytically calculated power of log-rank test based on our proposal was very similar to the empirical power based on simulations in various finite sample settings and was also useful to protect from overestimation and underestimation of the required sample size in the presence of cure fraction.

PMID:41243764 | DOI:10.1002/pst.70052

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Nevin Manimala Statistics

Integrative Machine Learning and Bayesian Analysis Reveals Atrial Fibrillation as a Key Predictor of Severe COVID-19 Outcomes

Clin Transl Sci. 2025 Nov;18(11):e70403. doi: 10.1111/cts.70403.

ABSTRACT

This study aimed to identify predictors of critical outcomes, including mortality, in hospitalized COVID-19 patients treated with remdesivir, using statistical, machine learning, and Bayesian methods. A retrospective multicenter cohort of 1628 patients hospitalized between January 2021 and August 2022 was analyzed. Clinical data were collected from electronic medical records. Multivariable logistic regression, machine learning models (LightGBM, Elastic Net) with SHapley Additive exPlanations (SHAP), and Bayesian logistic regression were applied. Among the cohort, 14.5% experienced critical outcomes or death. Advanced age (≥ 65 years; aOR 3.950), atrial fibrillation (aOR 4.087), and kidney disease (aOR 1.939) were identified as significant predictors. Machine learning models achieved moderate predictive performance (AUROC: LightGBM 0.705, Elastic Net 0.698), with SHAP highlighting atrial fibrillation and age as key contributors. Bayesian analysis confirmed a strong association between atrial fibrillation and adverse outcomes (adjusted OR 5.121). Atrial fibrillation emerged as a consistent and strong predictor, underscoring its relevance in clinical risk assessment.

PMID:41243757 | DOI:10.1111/cts.70403

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Nevin Manimala Statistics

Trends in Left Ventricular Assist Device Utilization and Survival Outcomes Following the Donor Allocation Policy Change

Artif Organs. 2025 Nov 17. doi: 10.1111/aor.70046. Online ahead of print.

ABSTRACT

BACKGROUND: We sought to estimate left ventricular assist device use (LVAD) with waitlist and post-transplant survival trends in patients supported on durable LVAD in relation to the UNOS donor heart allocation policy revision.

METHODS: Adult patients implanted with HeartMate II LVAD, HeartWare HVAD, or HeartMate 3 LVAD, and listed for isolated heart transplantation between October 18, 2013, and June 16, 2023, were identified in the UNOS database and were stratified into pre- and post-policy revision groups. Patients on temporary circulatory support, right, or biventricular assist devices, total artificial hearts, recipients of donation after circulatory death (DCD) hearts, and those undergoing simultaneous multiorgan transplants were excluded. Waitlist and post-transplant survival were compared between the groups.

RESULTS: Policy revision was associated with a decrease in LVAD use both at the time of listing (pre: 28% vs. post: 24.5%, p < 0.01) and at the time of transplant (pre: 45.8% vs. post: 31.7%, p < 0.01). For those listed with an LVAD, more patients eventually underwent transplantation (pre: 89.6% vs. post: 94.3%, p < 0.01) following the policy change. Overall waitlist and post-transplant survival among patients supported on LVAD worsened following the policy change, both showing statistical significance (p < 0.01).

CONCLUSION: In the post-policy era, a decline in durable LVAD utilization was observed, along with worse waitlist and post-transplant outcomes among LVAD-supported patients.

PMID:41243743 | DOI:10.1111/aor.70046