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Nevin Manimala Statistics

Development and psychometric testing of a caregiver self-efficacy scale for caregivers of individuals with serious mental illnesses

Rev Assoc Med Bras (1992). 2025 Jun 2;71(4):e20241551. doi: 10.1590/1806-9282.20241551. eCollection 2025.

ABSTRACT

OBJECTIVE: The aim of this study was to develop a scale to assess the self-efficacy of caregivers of individuals with serious mental illnesses and to determine its psychometric properties.

METHODS: This study used a methodologic, cross-sectional, and descriptive design. A draft of a 26-item scale was developed based on interviews with caregivers and a literature review. The construct validity of the scale was tested by exploratory factor analysis. The reliability of the scale was tested. Caregivers of 348 individuals with serious mental illnesses participated in the study.

RESULTS: The exploratory factor analysis produced a 20-item scale defined by three factors. Reliability coefficient values were adequate.

CONCLUSION: The caregiver self-efficacy scale for caregivers of individuals with serious mental illnesses developed in this study is a valid and reliable instrument that can be used for measuring the self-efficacy of caregivers of individuals with serious mental illnesses.

PMID:40465990 | DOI:10.1590/1806-9282.20241551

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Nevin Manimala Statistics

Nomograms versus artificial intelligence platforms: which one can better predict sentinel node positivity in melanoma patients?

Melanoma Res. 2025 May 27. doi: 10.1097/CMR.0000000000001047. Online ahead of print.

ABSTRACT

Nomograms are commonly used in oncology to assist clinicians in individualized decision-making processes, such as considering sentinel node biopsy (SNB) for melanoma patients. Concurrently, artificial intelligence (AI) is increasingly being utilized in medical predictions. This study aims to compare the predictive accuracy of nomograms and AI platforms for SNB positivity in a real-world cohort of melanoma patients. A retrospective analysis of melanoma patients who underwent SNB from 2020 to 2024 in a single institution was performed. Three open-access nomograms and three public AI platforms were employed to assess SNB positivity based on comprehensive clinical and pathological characteristics. Our cohort comprised 62 melanoma patients who have undergone SNB, of whom 12 (19.4%) were positive. There was no concordance among the three nomograms, nor among AI platforms (P < 0.001). Only the Memorial Sloan Kettering Cancer Center (MSKCC) nomogram scored statistically different between positive and negative SNB (P = 0.04), and ChatGPT was the only AI platform that was also statistically significant (P = 0.02). Only ChatGPT score was statistically significant for SNB positivity after univariate logistic regression (odds ratio: 1.05; 95% confidence interval: 1.004-1.108; P = 0.03). A receiver operating characteristic curve based on ChatGPT predictions generated a model with an area under the curve (AUC) of 0.702. Integrating MSKCC predictions marginally improved the model’s predictive performance, enhancing the AUC to 0.715. In conclusion, SNB positivity could be better performed by an AI platform in this cohort of patients. Enhancing AI platforms could provide better populations for nomogram validation, which would lead to better predictive models.

PMID:40465322 | DOI:10.1097/CMR.0000000000001047

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Generation of a Mouse Model of Fuchs Endothelial Corneal Dystrophy by Knock-in of CTG Trinucleotide Repeat Expansion in the TCF4 Gene

Invest Ophthalmol Vis Sci. 2025 Jun 2;66(6):18. doi: 10.1167/iovs.66.6.18.

ABSTRACT

PURPOSE: Fuchs endothelial corneal dystrophy (FECD) is frequently associated with trinucleotide repeat (TNR) expansion in the TCF4 gene intron. The aim of this study was to establish a novel FECD mouse model with TNR expansion.

METHODS: We used CRISPR/Cas9-mediated genome editing to generate knock-in mice carrying 100 CTG repeats in the Tcf4 intron. Corneal endothelial phenotypes were evaluated using specular microscopy and transmission electron microscopy. Transcriptome analysis was performed using RNA sequencing of corneal endothelial tissue from Tcf4(CTG)100/(CTG)100 and wild-type mice.

RESULTS: Tcf4+/(CTG)100 and Tcf4(CTG)100/(CTG)100 mice developed characteristic FECD features, including progressive guttae formation and decreased corneal endothelial cell density. At 60 weeks, Tcf4+/(CTG)100 mice showed increased guttae percentage (0.314% ± 0.145%) versus wild-type (0.170% ± 0.089%), although not statistically significant. Tcf4(CTG)100/(CTG)100 mice exhibited significantly higher guttae formation (0.563% ± 0.293%) compared to controls. Similarly, endothelial cell density showed non-significant reduction in Tcf4+/(CTG)100 (1629 ± 71 cells/mm2) versus wild-type (1704 ± 68 cells/mm2), whereas Tcf4(CTG)100/(CTG)100 mice demonstrated significant decrease (1600 ± 76 cells/mm2). RNA sequencing identified 3221 differentially expressed genes (579 upregulated, 2,642 downregulated), with enrichment in pathways related to adaptive immune response, chemokine signaling, and cytokine-cytokine receptor interaction.

CONCLUSIONS: Our study demonstrates that TNR expansion in the Tcf4 intron, on its own, is sufficient to induce FECD phenotypes in vivo. This mouse model provides a valuable tool for investigating FECD pathogenesis and developing targeted therapeutics.

PMID:40465262 | DOI:10.1167/iovs.66.6.18

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Nevin Manimala Statistics

Melanoma and pregnant women: a systematic review and meta-analysis

Melanoma Res. 2025 May 27. doi: 10.1097/CMR.0000000000001043. Online ahead of print.

ABSTRACT

Pregnancy-associated melanoma is melanoma that can develop up to 1 year postpregnancy. There is no solid evidence on how pregnancy can affect melanoma survival, recurrence, or mortality. This systematic review and meta-analysis aims to analyze the overall survival (OS), recurrence, and mortality rate in pregnant women diagnosed with melanoma. A comprehensive search was performed on Medline, Embase, and Web of Science to identify studies comparing melanoma in pregnant versus nonpregnant women. Hazard ratios (HRs) and risk ratios (RRs) with 95% confidence intervals (CIs) were estimated using a random-effects model. Heterogeneity was evaluated using the I2 statistic, and significance was defined as P values less than 0.05. Statistical analyses were conducted using RStudio 4.4.1. Our meta-analysis included 15 studies, consisting of 29 095 patients; 2917 (10%) were pregnant women. In the OS outcome, statistically significant differences were observed, favoring pregnant women in comparison to nonpregnant women; both groups were diagnosed with melanoma (HR: 0.81, 95% CI: 0.69-0.95, P = 0.012, I2 = 85.4%). The OS at 5 years did not show statistically significant differences (OR: 1.08, 95% CI: 0.50-2.35, P = 0.83, I2 = 57.9%). Similarly, the outcomes of melanoma recurrence (RR: 1.19, 95% CI: 0.95-1.48, P = 0.12, I2 = 0%) and mortality (RR: 1.60, 95% CI: 0.82-3.13, P = 0.16, I2 = 73.5%) also showed no statistically significant differences between groups. According to this systematic review and meta-analysis, pregnant women diagnosed with melanoma have a higher OS rate than nonpregnant women.

PMID:40465258 | DOI:10.1097/CMR.0000000000001043

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Simvastatin as Add-On Treatment to Escitalopram in Patients With Major Depression and Obesity: A Randomized Clinical Trial

JAMA Psychiatry. 2025 Jun 4. doi: 10.1001/jamapsychiatry.2025.0801. Online ahead of print.

ABSTRACT

IMPORTANCE: Major depressive disorder (MDD) and obesity are common noncommunicable disorders associated with substantial disease burden, which frequently occur comorbidly. Intriguingly, converging lines of evidence from animal models and genetic and observational studies have suggested a biological link between obesity, metabolic syndrome, and depression. Several small randomized clinical trials (RCTs) have suggested the antidepressive potential of statins.

OBJECTIVE: To examine whether simvastatin added to escitalopram is efficacious in improving depressive symptoms compared with add-on placebo.

DESIGN, SETTING, AND PARTICIPANTS: This was a confirmatory, double-blind, placebo-controlled, multicenter RCT. Adults with MDD and comorbid obesity from 9 tertiary care settings in Germany were enrolled in this analysis. Data were analyzed from July to October 2024.

INTERVENTIONS: Simvastatin (40 mg per day) or placebo as add-on to escitalopram (10 mg for the first 2 weeks, then increased to 20 mg until the end of study) in a double-blind fashion for 12 weeks.

MAIN OUTCOMES AND MEASURES: The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline (week 0) to week 12.

RESULTS: From August 21, 2020, to June 06, 2024, a total of 161 patients were enrolled at 9 sites in Germany, of which 160 patients were included in the intention-to-treat analysis (placebo: n = 79, simvastatin: n = 81; mean [SD] age, 39.0 [11.0] years; 126 female [79%]). Retention in the trial was excellent (95.6%), and blinding was effectively maintained. There were 4 serious adverse events with no difference between the groups. Primary end point analysis in the intention-to-treat sample showed no significant treatment effect of add-on simvastatin in MADRS scores (mixed models for repeated measures least squares mean difference, 0.47 points; 95% CI, -2.08 to 3.02; P = .71). No effects of simvastatin treatment were observed in any of the mental health-related secondary end points. However, simvastatin treatment significantly reduced low-density lipoprotein cholesterol (simvastatin, -40.37 mg/dL; 95% CI, -47.41 to -33.33 mg/dL; placebo, -3.78 mg/dL; 95% CI, -11.18 to 3.62 mg/dL; P < .001), total cholesterol (simvastatin, -39.07 mg/dL; 95% CI, -49.42 to -28.73 mg/dL; placebo, -4.89 mg/dL; 95% CI, -15.64 to 5.87 mg/dL; P < .001), and C-reactive protein (simvastatin, -1.04 mg/L; 95% CI, -1.89 to -0.20 mg/L; placebo, 0.57 mg/L; 95% CI, -0.28 to 1.42 mg/L; P = .003) compared with placebo.

CONCLUSIONS AND RELEVANCE: The study failed to meet its primary end point. This demonstrates that simvastatin did not exert additional antidepressive effects when added to escitalopram in patients with comorbid MDD and obesity, despite improving the cardiovascular risk profile.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04301271.

PMID:40465256 | DOI:10.1001/jamapsychiatry.2025.0801

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Learning topological horseshoes in time series via deep neural networks

Chaos. 2025 Jun 1;35(6):063115. doi: 10.1063/5.0270132.

ABSTRACT

Time-series analysis plays a crucial role in understanding the dynamics of real-world systems across various scientific and engineering disciplines. We in this paper propose a novel approach to identifying chaotic dynamics by a geometric method based on deep learning. Specifically, we construct a map from the observed time-series data and seek the existence of a topological horseshoe in the map, which indicates chaotic behavior. We demonstrate the effectiveness of our method by numerical experiments on the Hénon map, the Lorenz system, and the Duffing system. The results show that the topological horseshoe theory combined with deep neural works provides a valuable tool for detection of chaos in complex nonlinear systems from time series.

PMID:40465250 | DOI:10.1063/5.0270132

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Nevin Manimala Statistics

Evaluation of surgical modalities for stage 0 to stage II acral lentiginous melanoma: a National Cancer Database study

Melanoma Res. 2025 May 27. doi: 10.1097/CMR.0000000000001046. Online ahead of print.

ABSTRACT

Wide local excision (WLE) is the standing surgical choice for acral lentiginous melanoma (ALM), yet research is scarce in evaluating other surgical options for ALM and its recurrence rates remain two to five times more likely than other melanoma subtypes. This study evaluates the overall survival outcomes associated with different surgical modalities in patients with stage 0-II ALM. This retrospective cohort study surveyed the National Cancer Database from 2004 to 2021 for International Classification of Diseases-10 codes specific for all skin structures with histologically confirmed ALM for stage 0-II patients. Using IBM SPSS, statistical analyses were conducted via variable frequency with crosstabulations and Chi-squared tests, Kaplan-Meier survival curves with log-rank pairwise comparisons, and Cox proportional hazards regression models. Data for 6737 patients showed significantly greater overall survival for biopsy followed by gross excision (BFGE) than WLE [median overall survival = 204.8 months (P < 0.001); hazard ratio = 0.77 (95% confidence interval, 0.68-0.87)]. Median overall survival for WLE was 181.6 months. Cross analysis of Breslow depth (BD) with surgical procedures revealed the majority (21.8%) of WLEs were completed for lesions with a BD of 0.1-5 mm followed by 16.8% for lesions greater than 3 cm (P < 0.001). Crossanalysis of surgical margins of the primary site with surgical procedures, showed no residual tumor in 92.1% of all BFGE patients, which is 3.7% and 3.3% less patients than major amputation and WLE. This study highlights significant differences across ALM surgery options, suggesting each modality has their own niche and BFGE should be investigated further.

PMID:40465243 | DOI:10.1097/CMR.0000000000001046

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Real-world experience of postoperative adjuvant chemoimmunotherapy in patients with pancreatobiliary subtype ampullary adenocarcinoma

Oncologist. 2025 Jun 4;30(6):oyaf104. doi: 10.1093/oncolo/oyaf104.

ABSTRACT

BACKGROUND: The efficacy and safety of chemotherapy combined with programmed cell death protein-1 (PD-1) inhibitors in postoperative adjuvant therapy of pancreatobiliary subtype ampullary adenocarcinoma (AAC) are uncertain. This study aims to evaluate the effect of such treatment on the survival of this patient population.

METHODS: We retrospectively collected patients with pancreatobiliary subtype AAC who underwent surgical treatment at the Sun Yat-sen Memorial Hospital from January 2018 to December 2022. Patients with high-risk recurrence factors after surgery were divided into surgery alone group, adjuvant chemotherapy group, and adjuvant chemoimmunotherapy group. The Kaplan-Meier method was used to plot survival curves, and the Log-Rank method was used to compare the differences in overall survival (OS) and recurrence-free survival (RFS) between groups.

RESULTS: A total of 71 people were enrolled, including 24 patients received surgery alone, 31 patients received adjuvant chemotherapy, and 16 patients received adjuvant chemoimmunotherapy. The median time of clinical follow-up was 17.8 [IQR 8.3-28.4] months. The 1-year OS rates of the surgery alone group, adjuvant chemotherapy group, and adjuvant chemoimmunotherapy were 41.7%, 71.0%, and 93.3%, respectively. The 2-year OS rates were 28.6%, 47.7%, and 84.0%, respectively. The median OS was 6.8 months and 22.1 months, but the adjuvant chemoimmunotherapy group did not reach (P = .0002). The median RFS was 4.7 months, 15.7 months, and 14.8 months, respectively, but the differences were not statistically significant (P = .0613). Univariate and multivariate Cox analysis results showed that tumor size >2.3 cm (HR = 2.06, 95% CI, 1.06-4.04; P = .034) and the treatment regimen were independent factors affecting prognosis, compared to surgery alone and adjuvant chemotherapy (HR = 0.521, 95% CI, 0.26-1.04; P = .065), adjuvant chemoimmunotherapy (HR = 0.106, 95% CI, 0.02-0.47; P = .003) significantly improves patient survival. There was no statistically significant difference in any complications between the 3 groups (P > .05). Compared with the adjuvant chemotherapy group, patients in the adjuvant chemoimmunotherapy group are more likely to experience hypothyroidism (P = .044) and pruritus (P = .022). There is no statistically significant difference in other AEs between the 2 groups (P > .05).

CONCLUSION: Compared with surgery alone or adjuvant chemotherapy, patients with pancreatobiliary subtype AAC who received adjuvant chemoimmunotherapy showed better OS, and the drug-related toxicity was acceptable.

PMID:40465242 | DOI:10.1093/oncolo/oyaf104

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The terminal ileal vein approach: a novel and simple technique for locating the superior mesenteric vein and en bloc resection of the ileal mesentery in laparoscopic right hemicolectomy

Updates Surg. 2025 Jun 4. doi: 10.1007/s13304-025-02263-5. Online ahead of print.

ABSTRACT

Laparoscopic right hemicolectomy (Lap-RHC) presents technical challenges due to the complex vascular anatomy of the mesentery, which increases the risk of intraoperative bleeding and complicates surgical navigation. Accurate identification of the superior mesenteric vein (SMV) is crucial for maintaining surgical safety and achieving optimal oncological outcomes. To address these challenges, this study proposes the terminal ileal vein (TIV) approach, a novel technique designed to facilitate precise SMV identification and enable en bloc resection of the ileal mesentery while preserving mesenteric integrity. This retrospective cohort study evaluated a novel TIV approach compared to the traditional ileocolic vascular pedicle (IVP) approach for SMV identification and en bloc mesentery resection in patients with right-sided colon cancer. A total of 196 patients underwent Lap-RHC between 2022 and 2023, with 67 patients matched by propensity score included in both groups. The TIV approach involves initiating dissection at the TIV to accurately locate the SMV and facilitate en bloc resection of the ileal mesentery. In the balanced cohort, statistically significant differences were observed between groups regarding operation times (186 [120-299] vs. 210 [146-375] minutes, p = 0.001) and intraoperative blood loss (50 [20-400] vs. 70 [20-600] mL, p = 0.033). Differences were also found for time to urinary catheter removal (1 [1-3] vs. 2 [1-5] days, p = 0.012) and postoperative hospital stays (6 [5-12] vs. 7 [5-15] days, p = 0.006). The calculated importance proportion of the TIV approach related to these perioperative variables was between 15 and 25%. In this retrospective cohort, the TIV approach demonstrated reproducible entry into the mesenteric dissection plane and was accompanied by perioperative outcome differences that may reflect technical simplification. Further prospective investigation is needed to determine its clinical utility.

PMID:40465205 | DOI:10.1007/s13304-025-02263-5

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Healthcare Resource Utilization 6 Months Before and After Olanzapine/Samidorphan Initiation: Real-World Assessment of Patients with Schizophrenia or Bipolar I Disorder

Adv Ther. 2025 Jun 4. doi: 10.1007/s12325-025-03211-w. Online ahead of print.

ABSTRACT

INTRODUCTION: A combination of olanzapine and samidorphan (OLZ/SAM), approved by the US Food and Drug Administration (2021) for the treatment of adults with schizophrenia (SZ) or bipolar I disorder (BD-I), mitigates weight gain associated with olanzapine treatment. This study examined changes in healthcare resource utilization (HCRU) among patients with SZ or BD-I after initiating OLZ/SAM.

METHODS: This retrospective analysis utilized USA-based administrative claims data from April 19, 2021 to December 31, 2022. Adults aged ≥ 18 years with SZ or BD-I who had continuous enrollment ≥ 6 months before (baseline) and after (follow-up) OLZ/SAM initiation (index) were eligible. HCRU comparisons included inpatient admissions, average number of inpatient days, emergency department (ED) visits, and outpatient visits between 6-month baseline and follow-up periods.

RESULTS: In total, 1546 patients initiated OLZ/SAM (SZ: n = 855, mean age 39.4 years, 52.6% male; BD-I: n = 691, 38.4 years, 31.0% male). Overall, 446 (52.2%) patients with SZ and 302 (43.7%) patients with BD-I remained on OLZ/SAM during the full 6-month follow-up (median days persistent 182 and 106, respectively). In the SZ and BD-I cohorts, proportions of patients with all-cause and mental health (MH)-related inpatient admissions and ED visits significantly decreased between baseline and follow-up (all-cause: all P ≤ 0.026; MH-related: all P < 0.001). Findings were similar for disease-specific outcomes with the exception that reductions in BD-I-related ED visits were not significant. Average number of inpatient days decreased after OLZ/SAM initiation in both cohorts; in patients with BD-I, those reductions were statistically significant (all P ≤ 0.022). The proportions of patients with outpatient visits were similar between baseline and follow-up for both cohorts.

CONCLUSIONS: Results from this first real-world study assessing HCRU after OLZ/SAM initiation suggest that OLZ/SAM results in reductions in burden for patients, providers, and the healthcare system, as evidenced by reductions in acute all-cause, MH-related, and disease-specific HCRU among SZ and BD-I cohorts.

PMID:40465200 | DOI:10.1007/s12325-025-03211-w