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Nevin Manimala Statistics

Four Year Clinical and Cost Effectiveness of Vaginal Pessary Self-Management Versus Clinic-Based Care for Pelvic Organ Prolapse (TOPSY): Long Term Follow-Up of a Randomised Controlled Superiority Trial

BJOG. 2025 Aug 20. doi: 10.1111/1471-0528.18333. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare long-term clinical and cost-effectiveness of pessary self-management (SM) with clinic-based care (CBC) for pelvic floor-specific quality of life (QoL).

DESIGN: Four-year questionnaire follow-up of trial participants.

SETTING: UK pessary clinics.

SAMPLE: Responders at 4 years aged ≥ 18 years at recruitment, using a pessary (except Shelf, Gellhorn or Cube) which had been retained ≥ 2 weeks.

EXCLUSIONS: limited manual dexterity; cognitive deficit; pregnancy; requiring non-English SM teaching.

METHODS: SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received routine appointments. Allocation was by remote web-based application, minimised on age, user type (new/existing) and centre with no blinding. Participants were invited to opt into a 4-year follow-up. The primary analysis was intention to treat.

OUTCOME MEASURES: The primary outcomes were pelvic floor-specific QoL (PFIQ-7) and incremental net monetary benefit (INB) 4 years post-randomisation. Secondary outcomes included complications and prolapse symptoms.

RESULTS: Of 340 women randomised, 186 (55%) responded at 4 years (86/169 [51%] SM, 100/171 [58%] CBC). There was no statistically significant group difference in PFIQ-7 at 4 years (mean SM 32.9 vs. CBC 31.4, adjusted mean difference [AMD] SM-CBC 4.86, 95% CI -6.41 to 16.12). There was a statistically non-significant lower percentage of pessary complications for SM (SM 17.7% vs. CBC 22.0%, AMD 3.01 CI -0.58 to 6.61). At 4-years, SM was cost-effective (INB £2240). There was one potentially related serious adverse event (SM group).

CONCLUSIONS: Pessary self-management is an effective and cost-effective long-term option for women with prolapse.

TRIAL REGISTRATION: ISRCTN number: 62510577 (https://doi.org/10.1186/ISRCTN62510577).

PMID:40832737 | DOI:10.1111/1471-0528.18333

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Nevin Manimala Statistics

Modeling the importance of life exposure factors on memory performance in diverse older adults: A machine learning approach

Alzheimers Dement. 2025 Aug;21(8):e70428. doi: 10.1002/alz.70428.

ABSTRACT

INTRODUCTION: Many health life exposure factors (LEFs) influence cognitive decline and dementia incidence, but their relative importance to episodic memory (an early indicator of cognitive decline) among diverse older adults is unclear. We used machine learning to rank LEFs for memory performance in a large and diverse US cohort.

METHODS: Kaiser Healthy Aging and Diverse Life Experiences (KHANDLE) and Study of Healthy Aging in African Americans (STAR), participants underwent neuropsychological testing and answered questionnaires about multiple LEFs. XGBoost and Shapley Additive exPlanation values ranked the importance of factors influencing cross-sectional episodic memory in the full sample and by sex and ethnic group.

RESULTS: Among 2245 adults (mean age: 74 years; range 54-90), age, sex, education, volunteering, income, vision, hearing, sleep, and exercise contributed to memory performance regardless of group stratification.

DISCUSSION: This innovative methodology can help identify risk factors important for memory performance and guide future dementia risk reduction interventions among older adults.

HIGHLIGHTS: This work uses a regression tree machine learning model (XGBoost) with highly interpretable Shapley Additive exPlanation values to analyze impacts of 12 life exposure factors plus age, sex and ethnoracial identity on episodic memory outcome. This approach has valuable properties, including the ability to implicitly account for variable interactions, non-linear relations with outcome, and missing values. Age, sex, education, income, volunteering, exercise, hearing and vision, and sleep (quality and duration) have important impacts on memory outcome in a combined model and in stratified models regardless of ethnoracial identity. We also demonstrate individualized models for subgroups of participants, showing how life exposure factors vary in importance between divergent populations and suggesting an approach to personalized interventions. This approach can be valuable for both policy decisions and individualized interventions to support healthy cognitive aging.

PMID:40832727 | DOI:10.1002/alz.70428

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Nevin Manimala Statistics

Tumor Habitats Based on Multiparametric MRI Distinguish Atypical Glioblastoma From Primary Central Nervous System Lymphoma: Imaging-Pathologic Correlation

J Magn Reson Imaging. 2025 Aug 20. doi: 10.1002/jmri.70080. Online ahead of print.

ABSTRACT

BACKGROUND: Atypical glioblastoma (GBM) (minimal or no necrosis on MRI) and primary central nervous system lymphoma (PCNSL) are difficult to distinguish on MRI; whether tumor habitat can more accurately distinguish atypical GBM from PCNSL remains uncertain.

PURPOSE: To evaluate the diagnostic performance with tumor habitats, apparent diffusion coefficient (ADC), and edema index (EI) to distinguish atypical GBM from PCNSL.

STUDY TYPE: Retrospective.

POPULATION: One hundred twenty-five patients (63 male and 62 female) diagnosed with atypical GBM or PCNSL were included.

FIELD STRENGTH/SEQUENCE: 1.5 T and 3.0 T, Axial ADC and T1 contrast-enhanced spin-echo inversion recovery sequence (T1-CE).

ASSESSMENT: The tumor habitat was derived using T1-CE and ADC sequences. Based on this tumor habitat, EI and relative ADC (rADC), we constructed a model.

STATISTICAL TESTS: Logistic regression; Akaike Information Criterion; Receiver operating characteristic (ROC) curves, calibration curves, and Decision Curve Analysis.

RESULTS: Three tumor habitats were identified: high-enhancement cellular habitat (Habitat 1), low-enhancement cellular habitat (Habitat 2), and nonviable tissue habitat (Habitat 3). The voxel fraction of the three tumor habitats in atypical GBM and PCNSL groups shows statistically significant differences. The EI of patients in the PCNSL group was significantly higher than that of the patients in atypical GBM. A model was established incorporating the parameters Habitat 2, Habitat 3, EI, and rADCmean. The model exhibits excellent discriminative ability in the training set (AUC = 0.851, 95% CI: 0.781-0.921) and validation set (AUC = 0.807, 95% CI: 0.724-0.889). Histopathological evaluation showed that vasculogenic mimicry (VM) levels were significantly higher in the PCNSL group. Multiple linear regression analysis showed a significant correlation between habitat voxel fraction and VM levels.

DATA CONCLUSION: A model built based on tumor habitat, EI, and rADCmean can differentiate atypical GBM from PCNSL preoperatively. The differences in VM levels are one of the pathological mechanisms underlying the variations in tumor habitats between atypical GBM and PCNSL.

TECHNICAL EFFICACY STAGE: 3.

PMID:40832718 | DOI:10.1002/jmri.70080

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Nevin Manimala Statistics

Periprocedural Use of Hypochlorous Acid Mist for Improving Healing and Cosmesis of the Face After Laser

J Cosmet Dermatol. 2025 Aug;24(8):e70412. doi: 10.1111/jocd.70412.

ABSTRACT

BACKGROUND: Laser resurfacing treatments have revolutionized dermatological procedures by improving skin texture, tone, and quality. Effective periprocedural care remains essential to reduce side effects, support healing, and optimize aesthetic outcomes. Hypochlorous acid (HOCl), a naturally occurring oxidant with anti-inflammatory and antimicrobial properties, has demonstrated efficacy in promoting wound healing and minimizing scarring.

AIM: To evaluate the use of stabilized HOCl mist in the periprocedural care of patients undergoing laser resurfacing.

METHODS: Ten patients underwent treatment with UltraClear, CO2RE, and/or GentleMax Pro laser devices. Stabilized HOCl mist was applied before and after the procedure, with continued application twice daily for 1 week posttreatment. Follow-up assessments at 1-3 weeks and 1-3 months post-procedure included clinical photography, tolerability evaluation, and aesthetic outcome assessment. Outcomes measured included Clinician Erythema Assessment (CEA), 4-point Edema Scale, Investigator Global Assessment of Pigmentation Scale (IPA), and Global Aesthetic Improvement Scale (GAIS). Statistical analysis was performed using the Friedman and Wilcoxon signed-rank tests.

RESULTS: HOCl mist was associated with accelerated recovery, including a noticeable reduction in erythema and pigmentation. Statistically significant improvements were observed in CEA (p = 0.007) and IPA (p = 0.012) scores, indicating reduced clinical severity and pigment alteration. Edema and GAIS scores showed no statistically significant change.

CONCLUSION: Stabilized HOCl mist is well-tolerated and may significantly aid post-procedural recovery by minimizing side effects and reducing discomfort. Results support the potential role of stabilized HOCl mist as a beneficial adjunct in post-laser skincare, contributing to faster healing, reduced inflammation, and enhanced cosmetic results.

PMID:40832716 | DOI:10.1111/jocd.70412

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Nevin Manimala Statistics

Early Thrombolysis and Outcomes in Central Retinal Artery Occlusion: An Individual Participant Data Meta-Analysis

Stroke. 2025 Aug 20. doi: 10.1161/STROKEAHA.124.049955. Online ahead of print.

ABSTRACT

BACKGROUND: This individual participant data meta-analysis aimed to determine whether time to treatment influences the effect of intraarterial thrombolysis (IAT), intravenous thrombolysis, and conservative standard therapy on visual outcomes in nonarteritic central retinal artery occlusion.

METHODS: We searched MEDLINE, CENTRAL, and Embase up to June 2023 for studies reporting treatment modality and peri-treatment best-corrected visual acuity (BCVA) for ≥5 participants, excluding patients with nonsevere vision loss (BCVA <1.0 logarithm of the minimum angle of resolution [logMAR]) or treated after 24 hours of symptom onset. The primary outcome was recovery from severe vision loss (final BCVA <1.0 logMAR). We used mixed-effect models and local polynomial regression to investigate nonlinear relationships between time to treatment and recovery from severe vision loss.

RESULTS: Of 4074 screened studies, individual participant data were sought from 52, with 35 contributing individual participant data for 1038 participants. In total, 783 patients met inclusion criteria (age, 64.8±13.3 years; 35.5% female; baseline BCVA, 2.3±0.5 logMAR). For every hour decrease in time to treatment, thrombolysis was associated with greater improvement in BCVA (intraarterial, 0.02 logMAR [95% CI, 0-0.04]; intravenous, 0.04 logMAR [95% CI, 0.00-0.07]) than conservative standard therapy (0.01 logMAR [95% CI, 0-0.02]). A nonlinear relationship was detected for intraarterial thrombolysis with a changepoint at 8 hours (95% CI, 6.7-9.4). Thrombolysis was associated with increased recovery from severe vision loss compared with conservative standard therapy (intraarterial within 6 hours: odds ratio, 2.72 [95% CI, 1.02-7.28], 27.2% versus 12.0%; intravenous within 4.5 hours: odds ratio, 3.32 [95% CI, 1.24-8.92], 28.8% versus 11.1%). Findings were consistent in subgroup analysis restricted to patients receiving recombinant tissue-type plasminogen activator. Monte-Carlo simulations showed that a randomized controlled trial would require 95 participants per group to achieve 80% power to detect an odds ratio of 3.0 for recovery from severe vision loss.

CONCLUSIONS: Early intervention in nonarteritic central retinal artery occlusion is associated with improvement in visual recovery, with intraarterial thrombolysis and intravenous thrombolysis outperforming nonthrombolytic treatments. These findings warrant confirmation in sufficiently powered randomized controlled trials.

PMID:40832714 | DOI:10.1161/STROKEAHA.124.049955

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Nevin Manimala Statistics

National Versus State-Level Racial Disparities in Acute Stroke Interventions Using Get With The Guidelines-Stroke Data

Stroke. 2025 Aug 20. doi: 10.1161/STROKEAHA.124.050446. Online ahead of print.

ABSTRACT

BACKGROUND: Racial disparities have been reported in stroke care, but understanding if there is regional variability is critical to focusing policies and resources. Here, we sought to study racial and ethnic inequity in the administration of thrombolysis and thrombectomy at the national and state levels.

METHODS: We conducted a retrospective cohort study using Get With The Guidelines-Stroke Program registry data from 2003 to 2022 to evaluate racial disparities in the administration of acute stroke treatments in US patients. We used mixed-effects modeling to analyze national and state-level disparities, adjusting for relevant demographic, clinical, and hospital-level characteristics.

RESULTS: 660 369 patients were eligible for thrombolysis and 105 184 patients for thrombectomy. The mean age was 70.21±14.48 years, and 50.18% were female. The race/ethnic distribution was 69.06% of non-Hispanic White, 16.88% of non-Hispanic Black, 7.02% of Hispanic, 2.84% of Asian, and 4.20% of American Indian/Alaska Native/Hawaiian/Pacific Islander patients. Eligible non-Hispanic Black patients had statistically higher thrombolytic rates compared with non-Hispanic White patients (adjusted odds ratio [aOR], 1.04 [95% CI, 1.03-1.06]), indicating no racial disparities in thrombolytic treatment at the national level. Similarly, equal or higher rates of thrombolytic administration were noted in other race/ethnic groups at the national level (Asian: aOR, 1.12 [95% CI, 1.09-1.16]; Hispanic: aOR, 1.14 [95% CI, 1.12-1.17]; and other: aOR, 1.10 [95% CI, 1.07-1.13]; P<0.0001). However, when non-Hispanic Black patients were compared with non-Hispanic White patients at the individual state level, there were disparities in many of the stroke-belt states. Racial disparities remained significant at the national level between non-Hispanic Black and non-Hispanic White patients and eligible thrombectomy patients after adjusting for patient- and hospital-level covariates (aOR, 0.85 [95% CI, 0.82-0.89]; P<0.0001).

CONCLUSIONS: These data suggest that racial/ethnic disparities in stroke care vary depending on the intervention and geographic location. Equitable utilization of thrombolysis nationally may underscore the benefits of quality improvement initiatives though state-level inequities persist. Endovascular thrombectomy utilization demonstrated race-based disparities in use, and further efforts are needed to ensure equitable care of patients with stroke in the United States.

PMID:40832710 | DOI:10.1161/STROKEAHA.124.050446

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Nevin Manimala Statistics

Drug Target Mendelian Randomization: Distinguishing Between Causal Mechanisms and Biomarkers of Those Mechanisms

Circ Genom Precis Med. 2025 Aug 20:e005336. doi: 10.1161/CIRCGEN.125.005336. Online ahead of print.

NO ABSTRACT

PMID:40832708 | DOI:10.1161/CIRCGEN.125.005336

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Nevin Manimala Statistics

Performance and Correlations of Myocardial Contraction Fraction Derived From MRI in Transfusion-Dependent Thalassemia Patients

J Magn Reson Imaging. 2025 Aug 20. doi: 10.1002/jmri.70086. Online ahead of print.

ABSTRACT

BACKGROUND: Myocardial contraction fraction (MCF) is a promising volumetric index of myocardial function.

PURPOSE: To evaluate the association of MRI-derived MCF with demographic characteristics, clinical data, MRI findings, and the history of heart failure in patients with transfusion-dependent thalassemia (TDT).

STUDY TYPE: Retrospective.

SUBJECTS: 1154 TDT patients (52.9% female, 37.46 ± 10.67 years) enrolled in the Extension-Myocardial Iron Overload in Thalassemia project and 167 healthy subjects (54.5% female, 36.33 ± 15.78 years).

FIELD STRENGTH/SEQUENCE: 1.5 T/cine imaging for assessment of left ventricular (LV) function parameters, gradient-echo T2* technique for myocardial iron overload (MIO) assessment, late gadolinium enhancement (LGE) imaging for detection of replacement myocardial fibrosis.

ASSESSMENT: MCF was calculated as LV stroke volume divided by LV myocardial volume.

STATISTICAL TESTS: Independent-samples t-test, Wilcoxon signed-rank test, and chi-squared test for comparison between groups; analysis of covariance; Pearson’s or Spearman’s correlations; univariable and stepwise multivariable linear regression analyses; receiver operating characteristic curve analysis for assessment of diagnostic efficiency and DeLong’s test for area under the curves (AUCs) comparison. Statistical significance was defined as p < 0.05.

RESULTS: Healthy subjects and TDT patients showed comparable MCF values (99.5% ± 15.0% vs. 102.7% ± 29.7%, p = 0.820). In TDT, MCF was significantly lower in males compared to females (98.4% ± 27.1% vs. 106.6% ± 31.3%) and in patients with diabetes (96.8% ± 29.7% vs. 103.7% ± 29.1%). MCF significantly decreased with age (R = -0.066). MCF was significantly correlated with global heart T2* values (R = 0.075), and patients with MIO (T2* < 20 ms) had a significantly lower MCF compared to those without (96.3% ± 22.0% vs. 103.3% ± 30.2%). MCF had a significant inverse correlation with the number of LGE-positive segments (R = -0.314). MCF demonstrated a diagnostic performance comparable to that of global heart T2* values in distinguishing between TDT patients with and without a history of heart failure (AUC 0.63 vs. 0.58, p = 0.401 for the difference). The LV ejection fraction did not significantly differentiate patients based on heart failure history (AUC = 0.55, p = 0.223).

DATA CONCLUSION: In patients with TDT, MCF was significantly correlated with MIO and LGE extent. Additionally, patients with a history of heart failure had significantly impaired MCF.

EVIDENCE LEVEL: 4. TECHNICAL EFFICACY: Stage 2.

PMID:40832696 | DOI:10.1002/jmri.70086

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Nevin Manimala Statistics

Efficacy and Safety of Radiofrequency and Focused Ultrasound in Facial Rejuvenation: A Single-Center, Single-Blind, Non-Randomized Prospective Trial

J Cosmet Dermatol. 2025 Aug;24(8):e70407. doi: 10.1111/jocd.70407.

ABSTRACT

BACKGROUND: Although both radiofrequency (RF) and focused ultrasound (FU) are commonly used non-invasive skin-tightening methods, comparative studies between the two methods are lacking.

OBJECTIVE: To study and compare the efficacy and safety of RF and FU in facial rejuvenation.

METHODS: We recruited 36 patients to receive a single treatment: the RF group (n = 21) and the FU group (n = 15). Every participant was evaluated on baseline (T0), 1-month follow-up (T1) and 3-month follow-up (T3). Three blinded dermatologists used the FLR scale, Modified Fitzpatrick Wrinkle Scale (MFWS), and Allergan Skin Roughness Scale to assess facial wrinkles. Safety profiles were recorded, and subjects completed questionnaires to provide subjective evaluations.

RESULTS: Intergroup comparison indicated that the ultrasound group showed superior efficacy over the RF group in the mid-face (Z = 2.915, p = 0.004) and lower face (Z = 2.142, p = 0.046) on T1. Intragroup comparison observed a statistically significant reduction in FLR and MFWS scores with both treatments. Subjective satisfaction aligned with objective results, and no severe adverse reactions were observed.

CONCLUSION: Both RF and FU are effective in facial rejuvenation, though their efficacy differs. They are comparably safe and yield high patient satisfaction.

TRIAL REGISTRATION: ChiCTR number: ChiCTR2500097849.

PMID:40832682 | DOI:10.1111/jocd.70407

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A hybrid long short-term memory with generalized additive model and post-hoc explainable artificial intelligence with causal inference for air pollutants prediction in Kimberley, South Africa

Front Artif Intell. 2025 Aug 4;8:1620019. doi: 10.3389/frai.2025.1620019. eCollection 2025.

ABSTRACT

The study addresses the problem of nonlinear characteristics of common air pollutants by proposing a deep learning time-series model based on the long short-term memory (LSTM) integrated with a generalized additive model (GAM). LSTM model captures both nonlinear relationships and temporal long-term dependencies in time-series data, and GAM provides insight into the statistical relationship between selected features and the target pollutant. The post-hoc eXplainable artificial intelligence (xAI) technique, local interpretable model-agnostic explanation (LIME), further explains the nonlinearity. Finally, causal inference was determined on the impact of the air pollutants relationship, thereby offering further interpretability in which deep learning models are deficient. Meteorological and air pollutant statistical records were leveraged from a Hantam (Karoo) air monitoring station in South Africa, and through a random sampling approach, synthetic data were generated for the city of Kimberley. The model was evaluated with the mean squared error (MSE), root mean squared error (RMSE) and mean absolute error (MAE) for different time-steps. The proposed referred to as long short-term memory generalized additive model based post-hoc eXplainable Artificial Intelligence (LSTM-GAM_xAI) model with a 10-day time-step and 5-day time-step for multiple pollutants prediction guaranteed least MSE. Though the causal effect analysis show no p-values (>0.88) for variables, the experiment results show that LSTM-GAM-xAI guaranteed the lowest MSE values across different time-steps.

PMID:40832676 | PMC:PMC12358413 | DOI:10.3389/frai.2025.1620019