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Nevin Manimala Statistics

Perilead Edema in Deep Brain Stimulation: Long-Term Outcomes and Etiologic Correlates

Neuromodulation. 2025 Oct 30:S1094-7159(25)01041-4. doi: 10.1016/j.neurom.2025.09.315. Online ahead of print.

ABSTRACT

OBJECTIVES: Deep brain stimulation (DBS) is an effective surgical procedure for the treatment of Parkinson disease (PD) and other movement disorders. Immediate and delayed complications after DBS surgery have been described. Perilead edema (PLE) is a DBS-related complication for which the etiology remains unknown. Moreover, PLE frequency and long-term effects are subjects of ongoing debate. Our study aims to elucidate the long-term clinical and neuropsychologic effects of PLE and to find possible etiologic correlates.

MATERIALS AND METHODS: We retrospectively collected clinical and neuropsychologic data from 51 patients with PD before and 1 year after DBS. PLE visualized on fluid attenuated inversion recovery magnetic resonance imaging (MRI) sequence was manually segmented. Using appropriate statistical tests, continuous and categorical variables were compared in patients with and those without PLE. A multivariate regression model was used to analyze the contribution of clinical variables to edema volume changes.

RESULTS: Overall, 68.62% of patients presented with PLE at the immediate postoperative MRI. Patients with PLE were significantly older (p < 0.001) and had more frequent postoperative confusion episodes (p = 0.025). Furthermore, more microelectrode recording (MER) tracks (p < 0.001) were used in patients with PLE. Multiple MER tracks were directly correlated with edema volume and were the only significant predictors of edema volume changes in a multivariate regression model. No differences were found in other clinical and neuropsychologic variables.

CONCLUSIONS: PLE is a frequent postsurgical event and may cause transient postoperative confusion. It seems linked to older age and multiple MER tracks. Although it does not influence global motor and neuropsychologic outcomes, PLE contributes to postoperative confusion episodes. To avoid PLE sequelae, using multiple MER tracks in older patients should be discouraged.

PMID:41165632 | DOI:10.1016/j.neurom.2025.09.315

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Effect of Different Temperature Management Regimens on Cesarean Section Patients: A Randomized Controlled Trial

J Perianesth Nurs. 2025 Oct 29:S1089-9472(25)00164-9. doi: 10.1016/j.jopan.2025.05.016. Online ahead of print.

ABSTRACT

PURPOSE: To explore the effects of different warming temperatures on the incidence of hypothermia, comfort, and satisfaction of patients after a cesarean section.

DESIGN: A randomized controlled trial.

METHODS: A simple random sampling method was used to select 100 puerpera who underwent cesarean section surgery at the Anesthesia and Operating Department of a 3-class hospital from August 1, 2024 to October 31, 2024. They were randomly divided into a control group (49 cases) and an experimental group (51 cases). Observation indicators: changes in body temperature, comfort level, satisfaction level, incidence and intensity of chills.

FINDINGS: There was no significant difference in baseline data and body temperature between the two groups (P > .05). The incidence of postoperative shivering in the control group was 0%, which was lower than 3.92% in the experimental group. The control group’s comfort score was significantly higher than that of the experimental group, with statistical significance (P < .001). There was no significant difference in satisfaction evaluation or in the incidence of hypothermia between the two groups (P > .05).

CONCLUSIONS: The active and passive composite warming method can effectively prevent the occurrence of hypothermia and shivering in patients after cesarean section and improve their satisfaction. When the warming temperature is set at 38 to 40 ℃, postoperative comfort of patients is the best. However, short-term (30 minutes) postoperative warming has no significant effect on the postoperative body temperature of patients, and some patients still have a decrease in body temperature after short-term warming, suggesting that it is necessary to continue to promote warming measures to ensure the patient’s body temperature recovery after leaving the postanesthesia care unit and entering the ward.

PMID:41165620 | DOI:10.1016/j.jopan.2025.05.016

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Nevin Manimala Statistics

Sexual function in axial spondyloarthritis: a systematic review and meta-analysis

Rheumatology (Oxford). 2025 Oct 30:keaf578. doi: 10.1093/rheumatology/keaf578. Online ahead of print.

ABSTRACT

OBJECTIVES: This systematic review and meta-analysis examined how axial spondyloarthritis (axSpA), and its specific disease features, impact sexual function.

METHODS: Systematic review of medical literature databases PsycINFO, CINAHL, MEDLINE, Embase, and Cochrane Central from their inception to February 2025. Studies reporting sexual function outcomes in men or women with axSpA were included. After narrative synthesis of included studies, random-effects meta-analysis was used to pool a subset of outcomes. Study quality was assessed using a modified version of the ROBINS-E tool.

RESULTS: From the initial 342 identified studies, 37 were included. Nineteen (50%) examined sexual function in men only, 13 (34%) across both genders, five (13%) in women only, and one (3%) did not specify. Nine studies (24%) reported general sexual dysfunction prevalence in people with axSpA, ranging from 32-71%. A meta-analysis of studies (n = 4) examining the International Index of Erectile Function (IIEF) in men with axSpA found that all domain scores, except sexual desire, were worse compared with controls. In women with axSpA, a meta-analysis (n = 4) of Female Sexual Function Index (FSFI) data revealed significantly poorer total sexual function scores, and arousal, pain, lubrication and desire sub-domain scores compared with controls.

CONCLUSION: Between one- to two-thirds of people with axSpA report a sexual dysfunction. Pooling of data from a small subset of studies demonstrated statistically, and at times clinically, poorer sexual function scores in both men and women compared with controls. This conclusion is constrained by a lack of high-quality research and a notable scarcity of data concerning women.

PMID:41165594 | DOI:10.1093/rheumatology/keaf578

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Evaluation of a web-based self-monitoring application (MyRA) to empower people with rheumatoid arthritis in daily life

Rheumatology (Oxford). 2025 Oct 30:keaf565. doi: 10.1093/rheumatology/keaf565. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate MyRA, a web-based self-monitoring application for rheumatoid arthritis, on patient empowerment, usability, and perceived usefulness.

METHODS: MyRA was co-developed with patients and used at their own discretion during a 4-month prospective study with patient questionnaires at T0 (baseline), T1 (2 months) and T2 (4 months). The primary outcome was patient empowerment (Patient Activation Measure-13; 0-100). Secondary outcomes included frequency of use, usability (System Usability Scale; 0-100) and perceived usefulness (study specific questions). Descriptive statistics and repeated measures ANOVA were applied with post-hoc subgroup analysis based on frequency of use (subgroup A: 1-7 times; subgroup B: ≥8 times).

RESULTS: Among 548 registered patients (90.1% female, mean age 51.8 (SD 11.9) years, mean disease duration 10.2 (SD 10.1) years), 54 patients never used the application (9.9%), 405 patients were infrequent users (73.9%), and 89 patients were frequent users (16.2%). In the total user group, no statistical difference was found for patient empowerment after 4 months (T0: 55.8, T2: 54.4, p= 0.09). However, subgroup B showed a statistically significant, though not clinically meaningful, decrease (T0: 56.2, T2 53.6, p= 0.04). Subgroup B reported higher usability scores compared with subgroup A (75.9 vs 62.9, p< 0.001) and was more outspoken in perceived usefulness.

CONCLUSION: Despite major patient involvement throughout development, self-monitoring via MyRA did not increase patient empowerment. The study had a considerable decline in application engagement over time, with only a small subgroup of frequent users. These users showed more positive attitudes regarding usability and perceived usefulness of MyRA.

PMID:41165592 | DOI:10.1093/rheumatology/keaf565

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Nevin Manimala Statistics

Examining Inpatient Chemotherapy Utilization Among Patients with Cancer and Impact on Outcomes

Oncologist. 2025 Oct 30:oyaf214. doi: 10.1093/oncolo/oyaf214. Online ahead of print.

ABSTRACT

BACKGROUND: With the adoption of safer outpatient cancer care practices, much of cancer care has transitioned to outpatient settings, decreasing the need for inpatient systemic therapy (IST) which is associated with poorer end-of-life outcomes. We evaluated reasons for IST use, palliative care (PC) utilization, and outcomes among IST recipients to inform guidelines on appropriate IST use.

MATERIALS AND METHODS: We conducted a retrospective chart review of all IST admissions at an academic center from January 2016 to December 2017. Patients were stratified by solid tumor (ST) vs hematological malignancies (HM). We recorded IST urgency, response, mortality, and other variables. Descriptive statistics and odds ratios were estimated from logistic regression models with mixed-effect to account for multiple admissions per patient.

RESULTS: We analyzed 893 admissions (19% ST) among 620 patients. HM patients required frequent elective IST admissions than ST (p<.0001). ST patients more often received IST for non-urgent indications (p = 0.0032) during non-cancer related admissions. ST patients had fewer responses to IST compared to HM (36% vs 70%; p < 0.0001). PC services were more likely utilized for ST vs HM patients (48% vs 14%; p<.0001); and were associated with increased rates of health care proxy assignment, code status change and hospice discharge. Early 60-day mortality was higher for ST vs HM patients (17.3% vs 5.8%; p < 0.001) and most patients (55%) died inpatient during the index admission.

CONCLUSION: IST was overutilized in ST patients with poor response rates and significant early mortality. PC service utilization rates remain low but improved end-of-life transition planning.

PMID:41165589 | DOI:10.1093/oncolo/oyaf214

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IgE Guided Use of ICS in Patients with Stable COPD: A Real-World Observational Study

COPD. 2025 Oct 25;22(1):2579360. doi: 10.1080/15412555.2025.2579360. Epub 2025 Oct 30.

ABSTRACT

PURPOSE: This study investigated whether total serum IgE (T-IgE) can serve as a biomarker to guide personalized inhaled corticosteroid (ICS) therapy in patients with stable chronic obstructive pulmonary disease (COPD).

METHODS: We conducted retrospective (n = 1236) and prospective (n = 540) cohort studies of stable COPD patients. Participants were stratified by baseline T-IgE levels (cutoffs: 100 and 76 IU/mL). Propensity-score matching (PSM) was used to balance confounding factors, and a multivariate negative binomial regression model was constructed to evaluate the effects of ICS on the risks of exacerbations. Additionally, the stability of total serum IgE and its correlation with pulmonary function were analyzed.

RESULTS: In the subgroup with T-IgE ≥ 100 IU/mL, COPD patients had a significantly increased risk of exacerbations, with incidence rate ratios (IRRs) of 1.60 (95% CI 1.11-2.29) for moderate exacerbations, 1.37 (1.03-1.82) for moderate or severe exacerbations, and 1.15 (1.00-1.31) for all exacerbations. In this subgroup, ICS treatment significantly reduced the risk of the aforementioned exacerbations, with corresponding IRRs of 0.62 (0.42-0.91), 0.73 (0.53-1.00), and 0.84 (0.72-0.99). In contrast, in the T-IgE < 100 IU/mL subgroup, the benefits of ICS treatment were not statistically significant. Furthermore, total serum IgE demonstrated better stability than blood eosinophil counts and was negatively correlated with pulmonary function indices. Consistent results were obtained using a cutoff value of 76 IU/mL.

CONCLUSION: The total serum IgE level is closely related to exacerbations of COPD. Patients with high IgE levels can experience a reduced exacerbation rate when treated with ICS.

PMID:41165573 | DOI:10.1080/15412555.2025.2579360

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Box-Behnken Design-Based Development and Validation of RP-HPLC Method for Determination of Related Substances in Nitrofurantoin Formulations

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

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Real-World Effectiveness of Nirsevimab in Preventing RSV Hospitalizations: Evidence of Protection in Southern Italian Infants, 2024-2025

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

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Development and validation of the TabCAT-EXAMINER: A tablet-based executive functioning battery for research and clinical trials

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

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Artificial intelligence-driven framework for discovering synthetic binding protein-like scaffolds from the entire protein universe

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