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Nevin Manimala Statistics

Analysis of reported adverse events with esophageal dilation devices: a 10-year FDA manufacturer and user facility device experience database study

Dis Esophagus. 2026 Mar 2;39(2):doag032. doi: 10.1093/dote/doag032.

ABSTRACT

Esophageal dilation is a cornerstone therapeutic intervention in managing esophageal narrowing, using various types of dilation devices. While highly effective, it carries risks, including patient-related adverse events (PRAE) and device-related failures (DRF). Analysis of these complications is imperative for decision-making with the goal of enhancing procedural safety. Reports from the Manufacturer and User Facility Device Experience (MAUDE) database from January 2014 to June 2024 were analyzed. Although circulation numbers are unknown, event occurrence per device was compared using weighted averages of events and Poisson regression. A total of 1418 reports were identified, yielding 117 PRAE and 1845 DRF. The overall weighted average of PRAE was 0.07 (95% CI: 0.03, 0.11) per report, while DRF were 1.24 (95% CI: 1.13-1.36) per report. The most common PRAE was perforation (n = 32; 27%), with the most reports attributed to Rigiflex Pneumatic II (n = 13) and Savary-Giliard/American (n = 9). The most common DRFs pertained to material integrity issues which occur at relative rates 2.4 to 3.9 times higher than other device-related complications. About 117 PRAE reports were identified in the entire cohort. After excluding pneumatic dilation cases, it was determined that 70% (n = 71) of all PRAEs co-occurred with a material integrity issue. MAUDE analysis suggests variability in safety profiles across esophageal dilators. Perforation is the most reported PRAE across esophageal dilation procedures in general and may be linked to the co-occurrence of material integrity issues and aberrant guidewires in certain wire-guided polyvinyl dilators. To reduce PRAE occurrences, we encourage operators to recognize these patterns and their potential impact on adverse patient outcomes.

PMID:41967027 | DOI:10.1093/dote/doag032

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The prevalence, nature and trajectory of oropharyngeal dysphagia within the first year following curative open resection for esophageal cancer

Dis Esophagus. 2026 Mar 2;39(2):doag029. doi: 10.1093/dote/doag029.

ABSTRACT

In the absence of a mechanical stricture, oropharyngeal dysphagia following esophageal cancer surgery, and swallowing physiology more broadly, is poorly understood. This study investigated oropharyngeal dysphagia within the first year following curative open esophageal resection. A prospective cohort study was conducted (January 2022 to January 2024) at the National Esophageal Cancer Centre in Ireland. Participants were recruited between 6 to 12 months post-esophagectomy. A standardized videofluoroscopy was completed. Outcome measures included the Dynamic Imaging Grade of Swallowing Toxicity (DIGESTv2), Modified Barium Swallow Impairment Profile (MBSImP), and Penetration-Aspiration Scale (PAS). Functional Oral Intake Scale (FOIS) was used to identify oral intake status. To evaluate the trajectory of oropharyngeal dysphagia, long-term data were compared to previously published acute data findings. Seventeen participants (12 males; mean age 65 years, range 46-80) were included. The cohort comprised transthoracic (2-stage n = 7, 3-stage n = 3) and transhiatal (n = 7) resections. 11 participants (65%) had persistent oropharyngeal dysphagia (DIGESTv2), and 2 (12%) continued to aspirate greater than 6-months, both of whom had a transhiatal resection. 10 (59%) continued to modify their diet (abnormal FOIS <7). MBSImP revealed impaired initiation of swallow (82%), anterior hyoid excursion (82%), tongue base retraction (100%), pharyngeal residue (100%) and neo-esophageal clearance (82%). When comparing acute to longer term data, there was a statistically significant difference in aspiration based on PAS (P = 0.016), but not dysphagia based on the DIGESTv2 (P = 0.500). Oropharyngeal dysphagia is prevalent within the first year following open esophageal cancer surgery. The study informs the need for structured guidelines and a swallowing care pathway.

PMID:41967025 | DOI:10.1093/dote/doag029

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Nevin Manimala Statistics

Characterizing Middle-aged and Older Adults’ Perceptions of the Cultural Sensitivity and Quality of Generative Artificial Intelligence-authored Text Messages to Promote Physical Activity

J Gerontol B Psychol Sci Soc Sci. 2026 Apr 9:gbag062. doi: 10.1093/geronb/gbag062. Online ahead of print.

ABSTRACT

OBJECTIVE: Generative artificial intelligence (GenAI) could be used to write text message content in physical activity behavior change interventions for middle-aged and older adults. Yet, biases in GenAI systems could lead to culturally insensitive or low-quality messages. Evaluating the acceptability of GenAI-authored messages is crucial before use in interventions. This research examined middle-aged and older adults’ perceptions of the cultural sensitivity and quality of GenAI-authored messages for promoting physical activity, and the person- and message-level factors influencing these perceptions.

METHODS: In a cross-sectional survey, middle-aged and older adults (≥ 40 years of age; N = 630; Mean age = 56.8 years; SD = 10.1) read 80 text messages written by GenAI and identified those that were culturally insensitive or had other problems. Descriptive statistics identified the proportion of GenAI-authored messages labeled as having issues. Separate negative binomial regressions examined the participant (zero-inflated) and message factors associated with message issues.

RESULTS: Of 49,859 cultural sensitivity and 49,894 quality message ratings, only 4.9% and 6.1% of the messages, respectively, were labeled as having issues. Knowledge of AI-authorship and more favorable attitudes towards AI were associated with identifying more messages as culturally insensitive. Messages generated by prompts that targeted sitting less (compared to moving more) or that described preparing for activity (compared to performing physical activity) received more labels as containing quality issues.

DISCUSSION: GenAI can be prompted to write high-quality, culturally sensitive text messages for promoting physical activity for middle-aged and older adults. Message content and participants’ knowledge of AI use could influence perceptions.

PMID:41967012 | DOI:10.1093/geronb/gbag062

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Nevin Manimala Statistics

Electrical Burn Injuries in the United States: Recent Demographic, Clinical, and Regional Patterns from the BCQP Registry

J Burn Care Res. 2026 Apr 9:irag049. doi: 10.1093/jbcr/irag049. Online ahead of print.

ABSTRACT

Electrical injuries represent a small proportion of burn admissions but are associated with substantial morbidity. Prior studies suggest demographic and regional disparities in burn injury incidence and outcomes. This study aimed to compare electrical versus non-electrical burn injuries and assess regional differences in patient and burn characteristics, and outcomes using the American Burn Association’s Burn Care Quality Platform (BCQP). We conducted a retrospective cohort study using adult admissions from 2020 to 2022 to compare electrical to other types of burns. Outcomes included length of stay, mortality, discharge disposition, and insurance status. Regional analyses were based on the five ABA regions in the USA. Statistical comparisons used multivariate analyses, including propensity score matching. . Of a total of 63,269 patients, 2,042 (3.3%) sustained electrical injuries. These patients were younger (average age 40), predominantly male (92.2%), more likely to be injured at work (61.9%) and disproportionately Hispanic/Latino (21.9%). In the Southern region, electrical injuries resulted in significantly shorter median hospital stays than non-electrical injuries (2 vs. 3 days, p < 0.0001) shorter ICU stays (3 vs. 4 days, p ≤ 0.001). Mortality was consistently lower among electrical injury patients (2.2% vs. 3.7%, p ≤ 0.012). 52.7% of patients in the sample were treated in the Southern region, which also had the highest rate of electrical injuries in the country.The ABA Southern region bears a disproportionate burden, particularly among Hispanic/Latino and uninsured patients. These findings highlight the need for region-specific prevention, improved safety training, and equitable access to care.

PMID:41966997 | DOI:10.1093/jbcr/irag049

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Extended Follow-up from the Stereotactic Body Radiotherapy for High-risk Localized Carcinoma of the Prostate (SHARP) Consortium: Updated Analysis of 440 Patients

Eur Urol Oncol. 2026 Apr 10:S2588-9311(26)00078-7. doi: 10.1016/j.euo.2026.03.019. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Most patients with high-risk localized prostate cancer (HRLPC) do not undergo stereotactic body radiotherapy (SBRT) in part because of the limited evidence of long-term outcomes. We report long-term efficacy and toxicity outcomes for men treated with SBRT for HRLPC.

METHODS: Individual patient data from ten prospective clinical studies evaluating SBRT for HRLPC across nine institutions were pooled in the Stereotactic Body Radiotherapy for High-Risk Localized Carcinoma of the Prostate consortium. The Kaplan-Meier method was used to estimate 5-yr biochemical recurrence (BCR) and distant metastasis (DM), stratified by receipt of intensified treatment (≥12 mo of androgen deprivation therapy [ADT] with extremely dose-escalated [≥8 Gy/fraction] prostate-directed SBRT). The impact of intensified treatment on BCR-free survival and DM-free survival was evaluated using multivariable Cox proportional hazards models. Late Common Terminology Criteria for Adverse Events grade ≥2 gastrointestinal (GI) and genitourinary (GU) toxicity was analyzed using time-to-event models.

KEY FINDINGS AND LIMITATIONS: In 440 patients with a median follow-up time of 60.4 mo, 5-yr BCR and DM rates were 22% (95% confidence interval [CI] = 17-26%] and 9.2% (95% CI = 6.2-12%), respectively. In the 93 patients (21%) who received intensified treatment, 5-yr BCR and DM rates were 7.4% (95% CI = 1.7-13%) and 3.7% (95% CI = 0-7.9%), respectively. Receipt of intensified therapy was associated with a significant reduction in both BCR (hazard ratio [HR] = 0.38 [95% CI = 0.20-0.74], p = 0.005) and DM (HR = 0.43 [95% CI = 0.18-0.99], p = 0.049). For the overall cohort, 5-yr rates of grade ≥2 GU and GI toxicity were 23% (95% CI = 19-27%) and 10% (95% CI = 7-13%), respectively. Limitations include heterogeneous treatment techniques and the nonrandomized nature of the study.

CONCLUSIONS AND CLINICAL IMPLICATIONS: The safety and efficacy profile of SBRT for HRLPC remains favorable at long-term follow-up, and SBRT should be integrated into shared decision-making for treatment of HRLPC.

PMID:41966956 | DOI:10.1016/j.euo.2026.03.019

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Nevin Manimala Statistics

Integrating Genomic Prostate Score with Preoperative and Postoperative Cancer of the Prostate Risk Assessment Scores to Predict Biochemical Recurrence after Radical Prostatectomy

Eur Urol Oncol. 2026 Apr 10:S2588-9311(26)00062-3. doi: 10.1016/j.euo.2026.03.003. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Cancer of the Prostate Risk Assessment (CAPRA) score and its postsurgical variant (CAPRA-S) predict biochemical recurrence (BCR) after radical prostatectomy (RP) but do not capture tumor biology. We developed two integrated clinical scores, CAPRA-G and CAPRA-SG, combining CAPRA or CAPRA-S with Genomic Prostate Score (GPS).

METHODS: We analyzed 955 patients with Oncotype DX testing before RP. Associations between GPS, CAPRA, and CAPRA-S scores, and BCR were assessed using Cox models. CAPRA-G and CAPRA-SG were derived from β-coefficient weighting. Model discrimination was evaluated using Harrell’s C-index (3000 bootstrap resamples); differences were assessed with a nonparametric U-statistic. Decision-curve analysis compared CAPRA with CAPRA-G and CAPRA-S with CAPRA-SG.

KEY FINDINGS AND LIMITATIONS: Median follow-up was 60 mo (IQR 36-72). GPS predicted BCR independent of CAPRA or CAPRA-S (p < 0.001). Using log-hazard β-coefficients, one CAPRA and CAPRA-S point corresponded to » 6 and 10 GPS points, respectively, yielding CAPRA-G = CAPRA + GPS/6 and CAPRA-SG = CAPRA-S + GPS/10. Compared with CAPRA and CAPRA-S, CAPRA-G and CAPRA-SG showed a statistically significant improvement in C-indices, increasing from 0.67 to 0.76 (p < 0.001) and from 0.81 to 0.84 (p = 0.041), respectively. Decision-curve analysis demonstrated higher net benefit for CAPRA-G and CAPRA-SG at clinically relevant thresholds (» 0.05-0.45). Limitations included lack of external validation and under-representation of high-risk disease due to selective GPS prescription.

CONCLUSIONS AND CLINICAL IMPLICATIONS: GPS integration enhances BCR risk stratification in the RP setting. CAPRA-G and CAPRA-SG scores quantify genomic risk and translate GPS into simple, clinically applicable tools with improved clinical utility. External validation is warranted.

PMID:41966955 | DOI:10.1016/j.euo.2026.03.003

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Nevin Manimala Statistics

Distinct metabolic signatures of Alzheimer’s and Parkinson’s disease revealed through genetic overlap

EBioMedicine. 2026 Apr 10;127:106254. doi: 10.1016/j.ebiom.2026.106254. Online ahead of print.

ABSTRACT

BACKGROUND: Metabolic dysfunction is a major risk factor for neurodegeneration, yet the genetic architecture linking systemic metabolism to Alzheimer’s disease (AD) and Parkinson’s disease (PD) remains unclear.

METHODS: We integrated genome-wide association data for 249 circulating metabolites and proglucagon with summary statistics for AD, PD, and cardiometabolic traits. Genetic correlations, polygenic overlap, causal relationships, and shared genetic loci were quantified using linkage disequilibrium score regression, high-definition likelihood, bivariate mixture modelling, Mendelian randomisation, and conjunctional false discovery rate analyses, followed by functional and tissue-specific enrichment analyses.

FINDINGS: AD displayed a metabolic-genetic profile aligned with body mass index, type 2 diabetes, coronary artery disease, and stroke, whereas PD exhibited largely opposing patterns (Spearman’s rs = -0.26). Mendelian randomization analyses supported causal effects of lipoprotein subclasses, glutamine, and proglucagon on AD risk, with opposite or null effects in PD. Shared loci between metabolites and AD were enriched for lipid metabolism and cholesterol transport, whereas PD-associated loci were enriched for mitochondrial function, vesicle trafficking, and stress-response signalling.

INTERPRETATION: AD and PD are shaped by fundamentally distinct metabolic-genetic architectures. Metabolically targeted interventions, particularly those modulating lipid, amino acid, and proglucagon pathways, may require disease-specific and genetically informed strategies for prevention and treatment of neurodegenerative diseases.

FUNDING: Novo Nordisk Foundation (NNF23OC0099658), Marie Skłodowska-Curie Actions (801133), the Research Council of Norway (334920, 351751, 296030, 324252, 324499, 326813), the National Institutes of Health (U24DA041123, R01AG076838, U24DA055330, OT2HL161847, 5R01MH124839-02), NordForsk (164218), South-Eastern Norway Regional Health Authority (2020060), and the European Union’s Horizon 2020 (847776, 964874, 101057454).

PMID:41966729 | DOI:10.1016/j.ebiom.2026.106254

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Nevin Manimala Statistics

Income, treatment patterns and outcome in patients with stage IV colorectal cancer

Eur J Cancer. 2026 Apr 5;240:116732. doi: 10.1016/j.ejca.2026.116732. Online ahead of print.

ABSTRACT

INTRODUCTION: This study explores the association between income and patient- and treatment characteristics, diagnosis through screening and survival of patients with synchronous metastasized CRC.

METHODS: Patients diagnosed with stage IV CRC between 2015 and 2023 were selected from the Netherlands Cancer Registry. Income at postal code level was used (Statistics Netherlands). Multivariable logistic regression analyses were used to determine the association between income and treatment. Crude relative survival stratified for income was calculated, as well as relative excess risks of death using a multivariable generalized linear model.

RESULTS: The study included 24,666 patients, with respectively 33%, 35% and 32% having higher, intermediate and lower income. Detection through screening was more often realized in the higher income group compared to intermediate and lower income (9% vs. 8% vs.6%, p < 0.001). Among patients with single-organ metastases, higher income patients were more often treated with curative intent for metastases to the liver (40% vs. 35% vs. 29%, p < 0.001) and peritoneum (36% vs. 29% vs.22%, p < 0.001) compared to intermediate or lower income, also in multivariable analyses. Similarly, systemic therapy was given more frequently to patients with higher income than those with intermediate or lower income (56% vs. 51% vs.42%, p < 0.001). Crude 3-year relative survival was 21% (lower), 22% (intermediate) and 26% (higher income, adjusted RER higher vs. lower income: 0.93, [95%CI 0.90-0.97]; intermediate vs. lower income: 0.95, [95%CI 0.92-0.99]).

CONCLUSIONS: Patients with higher income were more likely to receive tumour directed treatment, including curative intent treatment which may result in the observed longer survival.

PMID:41966682 | DOI:10.1016/j.ejca.2026.116732

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Association between hemoglobin, albumin, lymphocyte, and platelet (HALP) score and overall survival in patients with cancer cachexia: A multicenter cohort study

Clin Nutr. 2026 Mar 30;60:106644. doi: 10.1016/j.clnu.2026.106644. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Nutritional status and inflammatory processes serve as significant factors that contribute to the development and progression of cancer cachexia. The hemoglobin, albumin, lymphocyte, and platelet (HALP) score is an emerging marker for assessing nutritional and inflammatory status, however, its association with overall survival (OS) in patients with cancer cachexia remains unknown. This study aims to explore the prognostic value of the HALP score in patients with cancer cachexia.

METHODS: This is a multicenter cohort study that includes 3150 cancer patients diagnosed with cachexia between June 2012 and December 2019. The primary outcome is overall survival (OS) and the recommended cutoff point for the HALP score is calculated using the optimal stratification method. Kaplan-Meier survival analyses and multivariable Cox regression analyses are used to explore the association between the HALP score and OS. Restricted cubic spline and stratified analysis are used to further illustrate the association between HALP score and OS.

RESULTS: The median age of the included participants is 60 years and 59.3% is male. Cancer patients with cachexia have lower HALP scores which decreases with TNM staging progress. The optimal cut-off value for HALP associated with OS is 22.13. High HALP is associated with better OS in patients with cachexia (p < 0.0001) and presents in most cancer types. After adjusting for all confounders, high HALP is associated with a significant reduction in all-cause mortality (HR, 0.80, 0.71-0.89, p < 0.001). Further analysis indicates that this association varied by sex, showing greater benefit among females (HR, 0.68, 0.56-0.82, p < 0.001). High HALP shows the stronger protective effects when combined with favorable clinical characteristics (e.g., younger age, surgery, normal blood indices, etc.) corresponding to lower HALP group.

CONCLUSIONS: The HALP score is an independent prognostic factor in patients with cancer cachexia, especially among females. These findings suggest that HALP may serve as an effective prognostic indictor for cachexia patients and provide insights for clinical risk assessment and management decisions.

PMID:41966680 | DOI:10.1016/j.clnu.2026.106644

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Mechanistic mapping of temperature-dependent ssDNA elasticity with oxDNA2 coarse-grained model

Eur Phys J E Soft Matter. 2026 Apr 12;49(4):35. doi: 10.1140/epje/s10189-026-00578-8.

ABSTRACT

The mechanical behavior of single-stranded DNA (ssDNA) controls its biological function and underpins the design of DNA-based nanodevices, yet the microscopic origin of temperature-dependent elasticity remains incompletely quantified. Here, we use the salt-aware, sequence-dependent oxDNA2 coarse-grained model to map how intra-strand stacking and temperature jointly determine ssDNA mechanics for two prototypical homopolymers, poly(dA)50 and poly(dT)50, across 27-100 °C at 1.0 M monovalent salt. Large ensembles of independent simulations were used to extract equilibrium observables such as persistence length l p , radius of gyration R g , end-to-end distance R ee , and equilibrium force-extension relations. We find that poly(dA) is substantially stiffer than poly(dT) at low temperature: l p ​ = 44.8 ± 2.0 nm at 27 °C decreases to 10.0 ± 0.7 nm at 100 °C, while poly(dT) remains comparatively flexible, varying only from 1.40 ± 0.08 nm to 1.05 ± 0.04 nm. These macroscopic changes closely track the loss of intra-strand stacking. For poly(dA), the stacking fraction decreases from 0.70 ± 0.02 to 0.20 ± 0.01, whereas poly(dT) remains weakly stacked across the full range (< 0.10). Force-extension analysis shows that the wormlike chain (WLC) model captures low-force entropic elasticity but fails at intermediate extensions in strongly stacked poly(dA), where cooperative unstacking produces excess forces of ~ 8 to 10 pN near x 0.6 L . The normalized root-mean-square residual at 27 °C is 0.22 for poly(dA), compared to 0.03 for poly(dT). When l p is normalized by its 27 °C value, both sequences collapse onto a single master curve as a function of stacking fraction (collapse slope ≈ 3.5 ± 0.3), indicating that fractional stacking loss serves as a unifying control parameter for thermal softening. These results quantitatively link microscopic stacking statistics to macroscopic elasticity, clarify the temperature-dependent limits of continuum polymer models, and provide a mechanistic framework for interpreting single-molecule stretching and ensemble measurements of ssDNA mechanics.

PMID:41966679 | DOI:10.1140/epje/s10189-026-00578-8