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Nevin Manimala Statistics

From exclusion to inclusion: Analysis of patterns of follow-up in breast cancer

Int J Surg Protoc. 2025 Sep 8;29(4):156-160. doi: 10.1097/SP9.0000000000000061. eCollection 2025 Dec.

ABSTRACT

INTRODUCTION: Follow-up data in breast cancer is essential and forms the basis for survival metrics and key statistical measures related to morbidity and mortality. Standard practice classifies any woman who does not engage in reviews/follow-up as “lost to follow-up (LTFU),” effectively excluding her from further analysis and disregarding her data. This study aims to evaluate patterns and predictors of LTFU among women with non-metastatic breast cancer.

DESIGN: This is a single-center prospective cohort study involving women diagnosed with non-metastatic breast cancer between 2017 and 2018. The study will follow a three-phase approach. In Phase I, 5-year follow-up data will be collected retrospectively through hospital records and electronic medical records (EMRs) up to 2024. In Phase II, patients identified as LTFU will be contacted using phone, SMS, or email to assess health status and update follow-up data. Informed consent will be obtained during outreach. In Phase III, patients who respond will be asked about reasons for missed follow-up visits, including barriers related to logistics, finance, awareness, or physician advice. Data will be analyzed using descriptive statistics, logistic regression, and thematic analysis.

OBJECTIVES: To determine the proportion of patients who are lost-to-follow-up at 5 years, identify factors associated with LTFU, and explore patient-reported barriers to follow-up in a public sector cancer care setting.

DISCUSSION: This study uses a mixed-methods approach, combining quantitative tracking with qualitative insights, with the aim of understanding patient retention and long-term oncology care. This study will provide real-world evidence on follow-up adherence and its determinants in a high-volume, resource-constrained oncology setting. The study is registered with ClinicalTrials.gov (Trial identifier: NCT06927102).

PMID:41334423 | PMC:PMC12668582 | DOI:10.1097/SP9.0000000000000061

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Exploring motivations and barriers in prostate cancer screening: lessons from a volunteer-based MRI screening study

Front Public Health. 2025 Nov 17;13:1646494. doi: 10.3389/fpubh.2025.1646494. eCollection 2025.

ABSTRACT

BACKGROUND: Prostate cancer remains a significant public health challenge, an early detection with prostate-specific antigen (PSA) testing and biparametric MRI (bpMRI) can improve outcomes. However, participation hinges on motivational, psychological, and logistical factors. This study examines the motivational profile of men in the ProstaPilot study to guide strategies to increase uptake of state-of-the-art prostate cancer screening programs.

METHODS: The ProstaPilot study enrolled 423 men who underwent both PSA testing and bpMRI of the prostate. Positive results (PSA ≥ 3 μg/L or PI-RADS 4-5 lesions) were referred for further urological examination and biopsy. Using an exploratory correlational design, 360 participants completed a detailed questionnaire. Motivational factors were extracted via Principal Component Analysis (PCA) with Oblimin rotation. Perceptions of prostate cancer risk, severity, and prevention were rated on 1-10 scales (10 = most positive).

RESULTS: PCA identified four motivational factors explaining 55.6% of variance: (1) concerns about screening (e.g., unnecessary surgery, loss of control); (2) perceived benefits of early detection; (3) social motivation (e.g., contributing to research, role modeling); and (4) barriers (e.g., logistics, embarrassment). Over half (51.1%) had not considered screening before ProstaPilot; others decided over varying timeframes. Participants showed high awareness of prostate cancer and valued early detection, rating screening effectiveness 9.55 ± 0.98 and trust in healthcare professionals 9.6 ± 1.0. Social/familial influences were moderate. Satisfaction was high: likelihood to recommend 9.45 ± 1.22; confidence in continuing participation 9.9 ± 0.39.

CONCLUSION: Highly motivated participants were marked by strong knowledge of prostate cancer screening, trust in healthcare providers, supportive social context, and high personal commitment. These findings support personalized, socially supportive, educational strategies to increase uptake of state-of-the-art screening.

CLINICAL TRIAL REGISTRATION: The study was registered on September 21, 2024, with the identifier number NCT05603351.

PMID:41334411 | PMC:PMC12665782 | DOI:10.3389/fpubh.2025.1646494

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Efficacy and Safety of Rituximab in Treating Adult Patients with Minimal Change Disease and Focal Segmental Glomerulosclerosis: A Prospective Study Compared with Glucocorticoids

Drug Des Devel Ther. 2025 Nov 27;19:10571-10587. doi: 10.2147/DDDT.S549834. eCollection 2025.

ABSTRACT

BACKGROUND: Minimal Change Disease (MCD) / Focal Segmental Glomerulosclerosis (FSGS) are leading causes of adult nephrotic syndrome. Roughly half of patients need long-term immunosuppression for steroid dependence or relapse, but traditional drugs carry substantial adverse effects. Rituximab (RTX) depletes CD20⁺ B cells and reduces anti-podocyte antibodies; pediatric data are encouraging, yet direct adult evidence-especially between treatment-naïve and relapsed patients-remains scarce.

METHODS: This study enrolled 82 patients with MCD/FSGS diagnosed between 2020 and 2023, divided into the RTX group (24 patients, 9 treatment-naïve and 15 relapsed) and the glucocorticoid group (58 patients). The RTX group received standard-dose RTX (375 mg/m2 weekly for 4 weeks), while the glucocorticoid group was treated with prednisone (1 mg/kg/day). Outcomes were compared using t-tests, χ2/Fisher, logistic regression, and Kaplan-Meier analyses.

RESULTS: The overall remission rates were 100% in the RTX group and 98.3% in the glucocorticoid group (P=0.876), but the RTX group had a significantly higher eGFR at the last follow-up (124.25 vs 109.00 mL/min/1.73 m2, P=0.019). A statistically significant intergroup difference was also observed, with complete remission achieved in 89.5% of MCD patients versus 40% of FSGS patients (P< 0.05). In relapsed patients treated with RTX, prednisone dosage decreased from 34.0±15.7 mg/day to 7.7±7.8 mg/day (P< 0.001), annual relapse frequency dropped from 1.0 to 0 episodes/year (P=0.001), and 40% of patients completely discontinued glucocorticoids. The Complete Remission rate in treatment-naïve patients (88.9%) was higher than in relapsed patients (73.3%), but the difference was not statistically significant. No independent predictors of RTX efficacy were identified, and no severe infections or allergic reactions were observed.

CONCLUSION: RTX equals glucocorticoids in podocytopathy, cuts steroid use and relapse, improves long-term kidney survival, and is safe. Treatment-naïve patients may choose RTX upfront to avoid steroid side effects; relapsed patients can taper and stop steroids. However, due to the limited sample size, these results should be interpreted with caution. Larger trials must confirm its long-term efficacy and ESRD protection.

PMID:41334365 | PMC:PMC12667706 | DOI:10.2147/DDDT.S549834

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Optic neuritis and risk of heart failure and atrial fibrillation: A nationwide cohort study

PNAS Nexus. 2025 Dec 1;4(12):pgaf312. doi: 10.1093/pnasnexus/pgaf312. eCollection 2025 Dec.

ABSTRACT

Autoimmune mechanisms are associated with both congestive heart failure (CHF) and atrial fibrillation (AF). Optic neuritis (ON) is known to elevate the risk of systemic autoimmune disorders. However, it remains uncertain whether ON serves as a risk factor for CHF and AF. This study aimed to investigate the association between ON and the risk of CHF and AF in a nationwide, population-based cohort. The research utilized data from Korea’s National Health Insurance Service, analyzing 15,587 patients newly diagnosed with ON and 77,935 age- and sex-matched controls from 2010 to 2017. Factors of demographics, medical history, lifestyle, and lab results were considered. CHF and AF incidences were identified through ICD-10 codes and analyzed using Cox regression models adjusted for confounders. During the 4-year follow-up, CHF and AF were diagnosed in 3.39 and 0.86% of participants, respectively. ON patients showed higher risks of CHF [hazard ratio (HR) = 1.341] and AF (HR = 1.215) after adjusting for potential confounders. Notably, stronger associations for CHF risk were found in patients younger than 50 years and those in the lowest income quartile. The findings provide compelling evidence of an independent association between ON and increased risks of CHF and AF, especially in younger individuals, suggesting a role of autoimmune processes in ON under these cardiovascular conditions. The study highlights the need for early cardiac evaluation in ON patients and suggests that timely interventions could improve prognosis. Further research is necessary to understand the pathophysiological links between ON and cardiovascular disorders.

PMID:41334361 | PMC:PMC12665501 | DOI:10.1093/pnasnexus/pgaf312

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Longitudinal changes in vitamin D during twin pregnancy: association with maternal-neonatal outcomes

Front Nutr. 2025 Nov 17;12:1667723. doi: 10.3389/fnut.2025.1667723. eCollection 2025.

ABSTRACT

INTRODUCTION: Existing studies suggest vitamin D (VD) deficiency links to adverse pregnancy outcomes in singletons; however, its association with specific adverse outcomes and neonatal health in twin pregnancies remains unclear. This study aimed to explore the relationship between maternal VD levels and maternal and neonatal outcomes in twin pregnancies.

METHODS: This study collected VD levels, pregnancy conditions, and neonatal anthropometry from 324 twin pregnancies. Peripheral blood serum was collected from mothers in mid- and late pregnancy to measure VD concentrations. Logistic models assessed VD’s association with pregnancy complications and neonatal anthropometry. The restricted cubic splines (RCS) method was used to estimate the risk threshold for spontaneous preterm birth (sPTB). Accounting for sample size and based on the Akaike (AIC) and Bayesian (BIC) information criteria, three knots were placed at the 10th, 50th, and 90th percentiles of the VD distribution. Missing data were handled using sensitivity analyses-including both optimistic and conservative assumptions-and multiple imputation methods.

RESULTS: Among all the participants, the mean mid-pregnancy VD concentration was 25.08 ± 8.31 ng/mL, with 25.6% having sufficient levels, 46.9% insufficient, and 27.5% deficient. Mid-pregnancy VD deficiency independently predicted sPTB (OR: 2.19; 95% CI: 1.07-4.50; p = 0.033). The RCS revealed an L-shaped VD-sPTB risk relationship. Each 1 ng/mL VD decrease increased sPTB risk by 14.94% (OR = 0.87). No statistically significant evidence was found between rising VD levels from mid- to late pregnancy and reduced sPTB risk vs. persistent low gestational VD levels. The analysis did not provide evidence for a statistically significant association between maternal mid-pregnancy VD levels and the incidence of hypertensive disorders of pregnancy (HDP), gestational diabetes mellitus (GDM), iatrogenic preterm birth (iPTB), or neonatal birth weight (all p > 0.05). In contrast, chorionicity (p = 0.004), HDP (p = 0.046), and neonatal sex (p = 0.021) were significant determinants of birth weight.

CONCLUSIONS: In twin pregnancies, maintaining adequate VD levels during mid-pregnancy represents a critical preventive window for reducing sPTB. For women with deficiency at this stage, the timing of supplementation may be more critical than dose. Although maternal VD status shows no significant association with neonatal anthropometry, the continued monitoring and optimization of VD levels throughout pregnancy remain essential for maternal-neonatal health.

PMID:41334344 | PMC:PMC12665537 | DOI:10.3389/fnut.2025.1667723

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The impact of weight loss in early pregnancy on the incidence of late gestational diabetes: a retrospective cohort study

Front Nutr. 2025 Nov 17;12:1688268. doi: 10.3389/fnut.2025.1688268. eCollection 2025.

ABSTRACT

OBJECTIVE: To study the potential correlation between pregnancy weight gain (WG) and the incidence of gestational diabetes mellitus (GDM).

METHODS: Clinical records of women with singleton pregnancies who had a first visit at Fujian Maternity and Child Health Hospital before 14 weeks and delivered after 28 weeks were retrospectively analyzed. Based on the first trimester WG, the participants were grouped as inadequate (iWG-F), adequate (aWG-F), and excessive (eWG-F) WG groups. The outcomes of interest included GDM, gestational hypertension, preeclampsia, small for gestational age (SGA), LGA, low birth weight (LBW), preterm birth, macrosomia, primarily cesarean section (CS), and admission to the neonatal intensive care unit (NICU). Statistical analyses included logistic regression, interaction, and mediation analyses.

RESULTS: A total of 16,824 pregnancies were analyzed. GDM incidences of the iWG-F, aWG-F, and eWG-F groups were 24.53%, 26.62%, and 29.46%, respectively, with a statistically significant difference (p < 0.001). Multivariable logistic regression showed that inadequate WG correlated with reduced risk of GDM when adjusted for pre-pregnancy body mass index (PPBMI) of below 18.5 kg/m2 [adjusted odds ratio (aOR) = 0.68], and 18.5-23.9 kg/m2 (aOR = 0.88). The association of inadequate WG and reduced risk of GDM persisted when adjusted for age <30.5 years (aOR = 0.81), fasting glucose ≥4.9 mmol/L (aOR = 0.74), triglycerides <1.4 mmol/L (aOR = 0.84), and HDL <1.63 mmol/L (aOR = 0.85). WG in the second trimester was associated with GDM (β = -0.003, p = 0.036) and partially mediated the effect of eWG-F (-3.7% of the total effect). WG before OGTT showed no association with GDM.

CONCLUSION: First trimester WG is significantly associated with the occurrence of GDM. In contrast, there is only a minimal association between second-trimester and pre-OGTT WG and the risk of GDM. Inadequate first-trimester weight gain reduces GDM risk, especially in younger women, women with normal or low PPBMI, elevated fasting glucose, and low HDL or triglycerides, without increasing abnormal neonatal birth weight. Early pregnancy represents a critical window for GDM prevention. Minimal weight gain during this period may be a feasible and acceptable approach to reducing GDM risk.

PMID:41334337 | PMC:PMC12665526 | DOI:10.3389/fnut.2025.1688268

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The development and validation of Coffee Use Disorder and Coffee Addiction Scale (CUDCAS) and its correlation with insomnia and anxiety symptoms

Front Nutr. 2025 Nov 17;12:1674097. doi: 10.3389/fnut.2025.1674097. eCollection 2025.

ABSTRACT

BACKGROUND: Coffee is a globally consumed beverage. However, the impairments associated with its excessive use remain under-recognized. There is currently no standardized measurement for coffee use disorder based on DSM-5 application. This study describes the development and psychometric properties of the Coffee Use Disorder and Coffee Addiction Scale (CUDCAS)-a self-report tool developed specifically for this purpose.

METHODS: A cross-sectional survey was designed and delivered to 523 participants. Items from CUDCAS (11 items with reference cluster) indicate substance use disorder criteria taken from the DSM-5 and were rated on a three point Likert scale and used descriptive statistics; internal consistency (Cronbach’s α and McDonald’s ω); exploratory/confirmatory factor analysis (EFA, CFA); item response theory (IRT), and correlations with caffeine consumption, insomnia (AIS) and anxiety symptoms (GAD-7) were also examined.

RESULTS: CUDCAS was found to be a very reliable (α and ω = 0.86) measure of coffee use disorder symptoms. CFA results supported the unidimensional factor structure of the CUDCAS and the overall model fit was good (CFI = 0.92, TLI = 0.90, RMSEA = 0.07, SRMR = 0.04). The IRT analyses further demonstrated an appropriate distribution of item difficulties, measurement of item precision and subsequently, CUDCAS as an overall measurement of coffee use disorder that is responsive to coffee consumption. CUDCAS also demonstrated significant correlations with caffeine consumption (r = 0.54), insomnia (r = 0.37), and anxiety (r = 0.32), respectively, for construct validity.

CONCLUSIONS: The findings suggest that the CUDCAS is a reliable and valid tool to assess the symptoms of coffee use disorder, and the current results provide support for its use in research and clinical settings.

PMID:41334329 | PMC:PMC12665531 | DOI:10.3389/fnut.2025.1674097

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The Relationship Between Social Support and Health-Promoting Behaviors among Older Adults in Fasa, Iran: A Cross-sectional Study

J Prev Med Public Health. 2025 Dec 1. doi: 10.3961/jpmph.25.502. Online ahead of print.

ABSTRACT

OBJECTIVES: Health-promoting behaviors are essential for maintaining independence and enhancing quality of life in aging populations. This study aimed to investigate the relationship between social support and health-promoting behaviors among older adults in Fasa, Iran in 2024.

METHODS: A cross-sectional study was conducted involving 300 older adults attending a specialized outpatient clinic in Fasa, Iran. Data were collected using a demographic questionnaire, the Walker Health-Promoting Lifestyle Profile, and the Canty Perceived Social Support Scale, administered either through self-report or structured interviews. Statistical analyses were performed using SPSS version 23 and included descriptive statistics, analysis of variance, the chi-square test, and multiple linear regression analyses.

RESULTS: The mean age of participants was 68.9 ± 7.8 years. Most participants were female (56.6%), married (81.7%), and had less than a high school education (41.3%). The mean scores for health-promoting behaviors and perceived social support were 124.2 ± 31.3 and 24.4 ± 9.4, respectively. A statistically significant positive association was observed between perceived social support and health-promoting behaviors (r=0.1, p=0.04). Social support, gender, and education level were identified as significant predictors of health-promoting behaviors, collectively explaining 34% of the variance.

CONCLUSIONS: These findings emphasize the pivotal role of social support in promoting health-related behaviors among older adults. Interventions that strengthen social support networks, foster enabling environments, and address gender and educational disparities are recommended to improve health outcomes and quality of life in aging populations. Policymakers and healthcare planners should incorporate these determinants into the design of targeted, evidence-based interventions for older adults.

PMID:41331744 | DOI:10.3961/jpmph.25.502

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Efficacy and safety of autologous adipose-derived stem cells in subjects with moderate to severe atopic dermatitis: a multicenter, randomized, single-blind, placebo-controlled, phase 2 trial

Stem Cell Res Ther. 2025 Dec 2;16(1):671. doi: 10.1186/s13287-025-04763-y.

ABSTRACT

BACKGROUND: Atopic dermatitis (AD) is a chronic skin condition affecting patients’ well-being, but conventional treatments have limitations. Mesenchymal stem cells (MSCs) present a promising option for AD therapy, though large-scale clinical studies are scarce. This study aimed to assess the efficacy and safety of autologous adipose tissue-derived MSC (AtMSC) in moderate to severe AD refractory to conventional treatments.

METHODS: This multicenter, randomized, single-blind, placebo-controlled, phase 2 trial included 114 participants. Participants received two intravenous injections of AtMSCs or placebo at 4-week intervals. Clinical assessments, comprising Eczema Area and Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), and Investigator’s Global Assessment (IGA), were performed every 4 weeks for 16 weeks total. Biomarker analyses were conducted using ELISA.

RESULTS: Statistically significant differences between the treatment and placebo groups in EASI total score were observed at 8, 12, and 16 weeks (P = .0.017, 0.015, < 0.001). At week 16, 23.7% [14/59] of participants in the treatment group achieved a 75% or greater reduction in EASI total score (EASI-75), compared to 7.3% [4/55] in the placebo group, with a statistically significant difference (P = .016). In addition, SCORAD, disease severity, and IGA score were also improved in the treatment group compared to the placebo group. Furthermore, the change in TARC levels from baseline to week 16 was significantly different between the treatment and placebo groups.

CONCLUSIONS: AtMSC therapy improved moderate to severe AD, offering a promising treatment option with potential applications in chronic inflammatory diseases. Further investigation, including double-blind phase 3 trials, is needed to confirm these findings and explore additional biomarkers.

TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT04137562; October 21, 2019; https://clinicaltrials.gov/study/NCT04137562 .

PMID:41331725 | DOI:10.1186/s13287-025-04763-y

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Polyunsaturated Fatty Acids and Skin Cancer: Two-Sample Mendelian Randomization Study

Ann Dermatol. 2025 Dec;37(6):363-376. doi: 10.5021/ad.25.095.

ABSTRACT

BACKGROUND: Observational studies have suggested associations between dietary polyunsaturated fatty acids (PUFAs) and cancer risk; however, causal inference regarding skin cancer remains limited due to potential recall bias, confounding, and reverse causation.

OBJECTIVE: This study aimed to evaluate the causal association between genetically predicted circulating PUFA levels and the risk of skin cancers, including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma.

METHODS: We conducted a 2-sample Mendelian randomization (MR) study using genome-wide association study summary statistics from the UK Biobank (PUFAs, n=115,006) and the FinnGen consortium (BCC, n=26,272; SCC, n=4,663; melanoma, n=5,753). Genetic instruments were derived for omega-3, docosahexaenoic acid, omega-6, linoleic acid, and the omega-6:3 ratio. Multiple MR methods-including inverse-variance weighted, MR-Egger, weighted median, weighted mode, and MR-PRESSO-were applied to test for consistency and assess pleiotropy and heterogeneity.

RESULTS: A higher genetically predicted linoleic acid to total fatty acid ratio was associated with a significantly lower risk of BCC and SCC. Conversely, higher genetically proxied serum omega-3 levels were associated with increased risks of BCC, SCC, and melanoma. The risk effect on SCC was attenuated upon exclusion of rs174528, a variant in the fatty acid desaturase 1 (FADS1) gene, suggesting a role for endogenous PUFA metabolism in carcinogenesis.

CONCLUSION: This MR analysis supports a causal role of circulating PUFAs in skin cancer development and highlights the importance of FADS-mediated endogenous PUFA metabolism. These findings provide novel insights into the genetic and metabolic underpinnings of skin cancer susceptibility.

PMID:41331717 | DOI:10.5021/ad.25.095