Category: Statistics

Biomed Chromatogr. 2025 Dec;39(12):e70247. doi: 10.1002/bmc.70247.

ABSTRACT

A stable reversed-phase high-performance liquid chromatography method was developed and validated to quantify related substances in nitrofurantoin capsule formulations. Based on response surface methodology and experimental design, the Box-Behnken design technique improved method performance and dependability. The mobile phase-A was formulated by mixing 0.2% formic acid solution and tetrahydrofuran in the ratio of 95:5% (v/v), and the mobile phase-B was formulated by mixing methanol, acetonitrile, and tetrahydrofuran in the ratio of 50:40:10 (v/v/v) using gradient elution with a flow rate of 0.8 mL/min. Chromatographic separation was achieved using an Inertsil ODS-3 C18 column (250 mm × 4.6 mm, 5 μm), with detection at 285 nm and column temperature maintained at 30°C. The method was validated according to ICH and USP <1225> guidelines. This is demonstrated by high-level accuracy, covering an entire range from 92% to 111%. Precision (resistance ≤ 1.0%) and linearity (R² > 0.999). Box-Behnken design-based RP-HPLC technique for nitrofurantoin formulations is significant because it uses a systematic, statistically optimized approach to method development to assure robustness, accuracy, and dependability. This work provides a proven stability-indicating approach for routine quality control and regulatory compliance to address safety concerns about nitrofurantoin degradation products and impurities.

PMID:41165558 | DOI:10.1002/bmc.70247

J Med Virol. 2025 Nov;97(11):e70662. doi: 10.1002/jmv.70662.

ABSTRACT

Respiratory syncytial virus (RSV) is a leading cause of hospitalization in infants, resulting in millions of cases and hundreds of thousands of deaths worldwide every year. Nirsevimab, a long-acting monoclonal antibody approved in 2023, has 75%-90% protection against RSV-related admissions. This study evaluated the effectiveness of nirsevimab in preventing RSV-hospitalization among infants in southern Italy during 2024-2025 season. Active surveillance was conducted in all hospitals in the Foggia district. Infants born between January 2024 and March 2025 who were hospitalized with lower respiratory tract infections from October 2024 to April 2025 were tested for RSV. Information on immunoprophylaxis was provided by the Regional Immunization Information System. The effectiveness of nirsevimab was estimated using the screening method, a test-negative case-control design and a cohort study approach. Of the 4820 eligible infants, 2635 (54.7%) were immunized. Of the 256 infants admitted with lower respiratory tract infections, 82 tested positives for RSV; of these, 13 had received immunoprophylaxis. The effectiveness was estimated to be 84.4% (95% CI: 71.7-91.4%) using the screening method, 72.5% (42.1%-87.0%) using the test-negative design, and 81.6% (66.4-90.0) using the cohort approach. As in previous study, these findings showed than nirsevimab provide substantial protection against RSV-related hospitalization.

PMID:41165546 | DOI:10.1002/jmv.70662

J Int Neuropsychol Soc. 2025 Mar;31(3):242-253. doi: 10.1017/S1355617725000177. Epub 2025 Oct 30.

ABSTRACT

OBJECTIVE: The National Institutes of Health (NIH) Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) is a validated laptop-based battery of executive functioning tests. A modified tablet version of the EXAMINER was developed on the UCSF Tablet-based Cognitive Assessment Tool (TabCAT-EXAMINER). Here we describe the battery and investigate the reliability and validity of a composite score.

METHODS: A diagnostically heterogeneous sample of 2135 individuals (mean age = 65.58, SD = 16.07), including controls and participants with a variety of neurodegenerative syndromes, completed the TabCAT-EXAMINER. A composite score was developed using confirmatory factor analysis and item response theory. Validity was evaluated via linear regressions that tested associations with neuropsychological tests, demographics, clinical diagnosis, and disease severity. Replicability of cross-sectional results was tested in a separate sample of participants (n = 342) recruited from a frontotemporal dementia study. As this separate sample also collected longitudinal TabCAT-EXAMINER measures, we additionally assessed test-retest reliability and associations between baseline disease severity and changes in TabCAT-EXAMINER scores.

RESULTS: The TabCAT-EXAMINER score was normally distributed, demonstrated high test-retest reliability, and was associated in the expected directions with independent tests of executive functioning, demographics, disease severity, and diagnosis. Greater baseline disease severity was associated with more rapid longitudinal TabCAT-EXAMINER decline.

CONCLUSIONS: The TabCAT-EXAMINER is a tablet-based executive functioning battery developed for observational research and clinical trials. Performance can be summarized as a single composite score, and results of this study support its reliability and validity in cognitive aging and neurodegenerative disease cohorts.

PMID:41165545 | DOI:10.1017/S1355617725000177

Brief Bioinform. 2025 Aug 31;26(5):bbaf573. doi: 10.1093/bib/bbaf573.

ABSTRACT

Compared to traditional sequence-based methods, artificial intelligence (AI) approaches offer distinct advantages, such as significantly improved structural recognition efficiency and the ability to overcome inherent limitations of sequence alignment. Here, we introduce an AI-driven framework designed to discover synthetic binding proteins (SBPs)-like scaffolds from the entire known proteome. The framework integrates a deep learning-based FoldSeek with our in-house developed holistic protein attributes assessment (HP2A) algorithm, and enables subsequent protein function annotation and evolutionary analysis. As a proof-of-concept, four representative SBPs, including Affibody, Anticalin, DARPin, and Fynome, were used as query to discover SBP-like scaffolds. The results demonstrate that some of the identified SBP-like proteins, despite their low sequence similarity (identity ≤0.3), exhibit significant structural resemblance to the templates (template modeling score (TM-score) ≥ 0.5), highlighting the large sequence space available within specific protein scaffold. Statistical analysis identifies key biophysical properties that contribute to privileged scaffold functionality. Additionally, evolutionary insights derived from potential SBP-like scaffolds provide valuable guidance for protein binder design, as validated through targeted sequence analysis and in silico site-directed mutagenesis. This work highlights the potential of our framework to facilitate the discovery of high-quality engineered protein scaffolds, paving the way for the development of novel SBPs.

PMID:41165486 | DOI:10.1093/bib/bbaf573

Environ Sci Technol. 2025 Oct 30. doi: 10.1021/acs.est.5c06486. Online ahead of print.

ABSTRACT

Agricultural pesticide exposure has been linked to cardiometabolic health, but little is known about the long-term effects of exposure to pesticide mixtures during sensitive developmental periods. We examined prenatal and early childhood exposure to agricultural pesticide use within one km of residences in the CHAMACOS cohort (n = 505) in California’s Salinas Valley. Twelve pesticides commonly applied in the region between 1999 and 2007 were included. At the age of 18 years, participants underwent clinical assessments of body mass index, waist circumference, insulin resistance, blood lipids, liver enzymes, and the presence of metabolic syndrome. Mixture associations were evaluated using statistical methods for correlated exposures, and single-pesticide models were examined separately. Analyses accounted for potential confounders and were stratified by sex. Higher early childhood exposure to the pesticide mixture was associated with increased odds of metabolic syndrome in males (OR = 1.76; 95% CI: 1.06, 2.05) but not females (OR = 0.87; 95% CI: 0.53, 1.26). Findings suggest that early life exposure to agricultural pesticide mixtures may contribute to adverse cardiometabolic outcomes in young men, underscoring the importance of considering sex-specific susceptibility in environmental health research.

PMID:41165481 | DOI:10.1021/acs.est.5c06486

Ther Apher Dial. 2025 Oct 30. doi: 10.1111/1744-9987.70092. Online ahead of print.

ABSTRACT

INTRODUCTION: This pioneering study aimed to examine the effects of virtual reality (VR)-based videos on symptoms, vital signs, and comfort levels in hemodialysis patients, offering an innovative approach to improving their quality of life.

METHODS: This randomized controlled pretest-posttest study included 54 hemodialysis patients treated at “X” Hospital between June 2024 and May 2025. Twenty-five patients were assigned to the intervention group, 25 to the control group, and 4 to a pilot group. Data were collected at baseline and after 8 weeks. Statistical analyses included t-tests, repeated measures ANOVA, Mann-Whitney U, and Friedman tests.

RESULTS: In the intervention group, Dialysis Symptom Index (DSI) scores decreased significantly (p < 0.05), and comfort levels increased significantly (p < 0.05) across all subscales of the Hemodialysis Comfort Scale Version II. Vital signs remained within normal ranges before and after the intervention.

CONCLUSION: This study revealed that the use of virtual reality headsets significantly influenced dialysis symptom index scores and comfort levels. The intervention effectively reduced dialysis symptoms and significantly increased patient comfort. No significant differences were observed in vital signs.

PMID:41164907 | DOI:10.1111/1744-9987.70092

Ann Hum Genet. 2025 Oct 30. doi: 10.1111/ahg.70029. Online ahead of print.

NO ABSTRACT

PMID:41164899 | DOI:10.1111/ahg.70029

Int J Dermatol. 2025 Oct 30. doi: 10.1111/ijd.70125. Online ahead of print.

ABSTRACT

BACKGROUND: The relationship between hidradenitis suppurativa (HS) and arthritis is well-established; however, the impact of their combined disease burden and the associated treatment pattern has not been determined yet. This study aimed to assess disease burden and therapeutic approaches in HS patients with and without arthritis and estimate arthritis prevalence and subtypes.

METHODS: A multicenter, retrospective, case-control study of 272 adults (69 with HS and arthritis; 203 with HS only), drawn from a hospital-based cohort of 3644 HS patients across 10 Spanish centers. Controls were matched 1:3 by sex, age, and HS duration. Statistical analysis included non-parametric tests, logistic regression, and linear mixed-effects models adjusted for confounders.

RESULTS: HS patients with arthritis had higher rates of immune-mediated diseases, including inflammatory bowel disease (odds ratio [OR] 9.44, p < 0.0001) and psoriasis (OR 2.99, p = 0.0038), higher Dermatology Life Quality Index (DLQI) scores (6.30 vs. 4.03, p = 0.031), more dermatology visits (7.00 vs. 5.00, p = 0.0077), and greater biologic therapy use (72.07% vs. 39.90%, p < 0.0001). The prevalence of arthritis among HS patients was 1.70% (95% confidence interval [CI]: 1.00%-2.70%), with spondyloarthritis being the most common subtype (66.6%).

CONCLUSIONS: HS patients with arthritis have a greater disease burden and higher biologic therapy utilization, emphasizing the need for interdisciplinary care and optimizing resources.

PMID:41164894 | DOI:10.1111/ijd.70125

Zhonghua Yi Xue Za Zhi. 2025 Oct 30;105:3650-3656. doi: 10.3760/cma.j.cn112137-20250826-02191. Online ahead of print.

ABSTRACT

Objective: To explore the accuracy and comprehensiveness of responses from four large language models [ChatGPT-3.5 (Model A), ChatGPT-4.0 (Model B), ChatGPT-4o (Model D) developed by OpenAI in the United States, and a domestically developed Obstetric artificial intelligence assistant robot (Model C)] to inquiries from patients with placenta accreta spectrum disorders and their families. Methods: A prospective study was conducted from June 2024 to March 2025, involving 25 pairs of patients and their families and 8 obstetric experts at the Third Affiliated Hospital of Guangzhou Medical University. Sixteen questions commonly asked by patients and their families regarding placenta accreta spectrum disorders were collected, covering six disease-related areas such as disease mechanism, risk factors, clinical symptoms, diagnosis, pregnancy management, and prognosis. A physician then input all the questions into the four different large language models to obtain their responses. The responses were randomized and independently evaluated by four maternal-fetal medicine physicians using a three-point Likert scale and a six-point Likert scale to assess the accuracy of the responses. The majority consensus method was used to determine the final rating for each model’s response. For responses rated as “good” and scored 5 or above on the six-point Likert scale, a three-point Likert scale was further used to assess the comprehensiveness of the content. The accuracy and comprehensiveness of the 4 large language models was compared. Results: Significant differences in accuracy were observed among the four large language models (P=0.005). 25% (4/16) of Model A responses were rated as “good”, which was lower than the 75% (12/16) for both Model B and Model D (both P<0.05). The comprehensiveness score for Model A was 1.8 (1.5, 2.0), for Model B was 2.0 (1.8, 2.0), for Model C was 2.3 (2.0, 2.3), and for Model D was 2.6 (2.3, 2.7). There were statistically significant differences in comprehensiveness scores among the four large language models (P<0.001). Pairwise comparisons showed that Model D was significantly more comprehensive than Model A (P=0.004) and Model B (P<0.001). Conclusions: Significant variations exist in both the accuracy and comprehensiveness of responses from the four large language models to questions in six areas related to placenta accreta spectrum disorders. Model D performs better in both aspects. Model C has a better performance in comprehensiveness, but its accuracy needs further improvement.

PMID:41164852 | DOI:10.3760/cma.j.cn112137-20250826-02191