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Nevin Manimala Statistics

Can 68Ga-PSMA-11 PET/CT renal uptake parameters predict renal function impairment?

Int Urol Nephrol. 2025 Sep 14. doi: 10.1007/s11255-025-04780-z. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim is to investigate the correlation between renal maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), molecular kidney volume (MKV), and total kidney uptake (TKU), which are indicators of the PSMA kidney uptake pattern in 68Ga-PSMA-11 PET/CT imaging and kidney function tests. We secondarily aim to investigate how accurately renal parameters obtained from 68Ga-PSMA-11 PET/CT can provide information about the patient’s kidney functions.

METHODS: The study included 196 patients with prostate cancer who underwent 68Ga-PSMA-11 PET/CT imaging for staging purposes. Semiquantitative analyses were performed on the kidneys in the PET/CT images, and renal SUVmax, SUVmean, MKV, TKU values, as well as anatomical kidney volume (CT-KV) from CT imaging, were calculated. The patients’ concurrent laboratory results, including eGFR, BUN, and creatinine levels, were recorded. Statistical analyses were performed using the SPSS 22 software. The Spearman test was used to determine the correlation between the parameters. The ANOVA test was used for intergroup comparisons, and the Tamhane test was used for post-hoc analyses.

RESULTS: When comparing eGFR, BUN, and creatinine values with PET/CT renal parameters, a significant correlation was found between eGFR and MKV (r = 0.397), TKU (r = 0.271), and CT-KV (r = 0.216). Similar correlations were also observed for BUN and creatinine. When patients were grouped based on eGFR values, Group 1 (eGFR > 90; normal) included 75 patients, Group 2 (eGFR: 89-60; mild reduction) included 98 patients, and Group 3 (eGFR: 59-30; moderate reduction) included 21 patients. Significant differences were observed between the groups in terms of TKU, MKV, and CT-KV. In post-hoc analyses, the most significant parameter was MKV.

CONCLUSION: 68Ga-PSMA-11 PET/CT-derived renal parameters, particularly the molecular kidney volume (MKV), exhibit a significant positive correlation with renal function and demonstrate a significant decrease in patients with renal dysfunction compared to those with normal renal function.

PMID:40947457 | DOI:10.1007/s11255-025-04780-z

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Nevin Manimala Statistics

Trends in accident-related traumatic dental injuries among children: a 10-year retrospective study of patients attending a university clinic

Clin Oral Investig. 2025 Sep 15;29(10):450. doi: 10.1007/s00784-025-06546-4.

ABSTRACT

OBJECTIVE: This study aimed to analyze accident-related traumatic dental injury (TDI) data to determine the occurrence, characteristics, and types of dental injuries in primary and permanent dentitions of underage patients attending a university clinic.

MATERIALS AND METHODS: A retrospective observational study was conducted at the Clinic of Orthodontics and Pediatric Dentistry of Zurich from 2010 to 2019 and involved children with accident-related TDIs from the ages of 0 to 18 years old. Data regarding patient- and trauma-related characteristics were extracted and analyzed statistically according to dentition, tooth, age, sex, and time elapsed before visiting the dentist at 5%.

RESULTS: The sample included 1,291 TDIs seen in a sample predominantly comprised of boys (59.8%), with a median age of 3.0 years (interquartile range 1.8-7.1 years), mostly in the deciduous dentition (71.6%) with ≥ 1 TDIs between 2010 and 2019. Accidents mainly occurred at home (45.6%) or outdoors (30.3%) and were primarily the result of falls (37.2%) or playtime (29.5%). Affected children often visited the dentist within the first 24 h (77.1%). Deciduous teeth (51.9%) and permanent teeth (37.2%; p = 0.001) primarily exhibited injuries to the periodontal tissue.

CONCLUSION: This study found boys were more prone to TDI than girls. Significant differences were seen in the injury mechanisms between deciduous and permanent teeth. Moreover, injuries to the periodontal tissue, with or without tooth fractures, were the most common trauma found.

CLINICAL RELEVANCE: Gaining insights into TDI patterns over time can help clinical practitioners develop more effective prevention measures.

PMID:40947438 | DOI:10.1007/s00784-025-06546-4

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Nevin Manimala Statistics

Trends in accident-related traumatic dental injuries among children: a 10-year retrospective study of patients attending a university clinic

Clin Oral Investig. 2025 Sep 15;29(10):450. doi: 10.1007/s00784-025-06546-4.

ABSTRACT

OBJECTIVE: This study aimed to analyze accident-related traumatic dental injury (TDI) data to determine the occurrence, characteristics, and types of dental injuries in primary and permanent dentitions of underage patients attending a university clinic.

MATERIALS AND METHODS: A retrospective observational study was conducted at the Clinic of Orthodontics and Pediatric Dentistry of Zurich from 2010 to 2019 and involved children with accident-related TDIs from the ages of 0 to 18 years old. Data regarding patient- and trauma-related characteristics were extracted and analyzed statistically according to dentition, tooth, age, sex, and time elapsed before visiting the dentist at 5%.

RESULTS: The sample included 1,291 TDIs seen in a sample predominantly comprised of boys (59.8%), with a median age of 3.0 years (interquartile range 1.8-7.1 years), mostly in the deciduous dentition (71.6%) with ≥ 1 TDIs between 2010 and 2019. Accidents mainly occurred at home (45.6%) or outdoors (30.3%) and were primarily the result of falls (37.2%) or playtime (29.5%). Affected children often visited the dentist within the first 24 h (77.1%). Deciduous teeth (51.9%) and permanent teeth (37.2%; p = 0.001) primarily exhibited injuries to the periodontal tissue.

CONCLUSION: This study found boys were more prone to TDI than girls. Significant differences were seen in the injury mechanisms between deciduous and permanent teeth. Moreover, injuries to the periodontal tissue, with or without tooth fractures, were the most common trauma found.

CLINICAL RELEVANCE: Gaining insights into TDI patterns over time can help clinical practitioners develop more effective prevention measures.

PMID:40947438 | DOI:10.1007/s00784-025-06546-4

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Nevin Manimala Statistics

Generalized additive mixed models to discern data-driven theoretically informed strategies for public brain, cognitive and mental health

Eur J Epidemiol. 2025 Sep 15. doi: 10.1007/s10654-025-01296-9. Online ahead of print.

ABSTRACT

Social isolation is recognized as a public health emergency. However, major guidelines provide vastly different recommendations on how to target it, and no strategy has been substantiated on firm theoretical or empirical grounds, yet. Rose’s seminal The Strategy of Preventive Medicine provided a theoretical framework for such arbitrations between approaches. Therein, determining the shape of the relationship between risk factor and outcome is of paramount importance. However, quantitative approaches immediately applying this theory to evidence are still lacking. Thus, in this pre-registered analysis, we pursued a novel approach and employed generalized additive mixed models to model the shape of social isolation’s Links to brain, cognitive and mental health outcomes in a well-characterised population-based sample. We derived brain measures from 3T MRIs, assessed cognitive functions with extensive neuropsychological testing and measured social isolation and mental health outcomes using established questionnaires. Overall, we studied over 10,000 (mean age 58a, 53% women) participants at baseline and over 5500 (mean age 64a, 53% women) at follow-up after ~ 6 years. The relationship of social contact with almost all outcomes was firmly linear and did not differ above and below the standard threshold for social isolation. Only for processing speed did we detect a steeper slope amongst socially isolated individuals. Hence, most of the health effects of social contact were observed in individuals that would not be categorised as socially isolated. Applying advanced statistical methods to a large and well-characterised dataset we provide evidence in support of a shift in focus away from individual-level and towards population-level preventive approaches.

PMID:40947435 | DOI:10.1007/s10654-025-01296-9

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Nevin Manimala Statistics

Bayesian Adaptive Enrichment Design for Continuous Biomarkers

Stat Med. 2025 Sep;44(20-22):e70262. doi: 10.1002/sim.70262.

ABSTRACT

With the advent of precision medicine and targeted therapies in cancer, new challenges in the statistical design of clinical trials have naturally emerged. Most randomized clinical trial designs incorporating predictive biomarkers (those associated with treatment efficacy) assume biomarkers are dichotomous, or dichotomize naturally continuous biomarkers upfront, or find cut points mid-way through the trial to classify patients as biomarker-positive or biomarker-negative. However, these practices ignore or discard information about continuous and possible nonlinear or non-monotone prognostic or predictive effects. In this article, we propose a novel adaptive enrichment trial design to handle continuous biomarkers with any effect shape, including Bayesian marker-adaptive randomization. We demonstrate that this design can correctly make marker-specific trial decisions with high efficiency, resulting in improved performance and patient-centered decisions compared to adaptive cut-point selection approaches without adaptive randomization that further ignore or oversimplify true underlying marker relationships.

PMID:40947424 | DOI:10.1002/sim.70262

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Nevin Manimala Statistics

Outcomes of Deltoid Ligament Repair in Surgically Treated Weber C Ankle Fractures With Deltoid Injury: A Retrospective Comparative Study

Foot Ankle Int. 2025 Sep 14:10711007251361122. doi: 10.1177/10711007251361122. Online ahead of print.

ABSTRACT

BACKGROUND: The indications for deltoid ligament (DL) repair in ankle fractures with widened medial clear space (MCS) remain controversial. Many authors report no difference in long-term functional outcomes, whereas others report persistent MCS widening and higher malreduction rates without DL repair. This study compares DL repair to no repair exclusively in surgically treated bimalleolar equivalent Weber C fibula fractures.

METHODS: This was a retrospective chart review of surgically treated Weber C lateral malleolus fractures with syndesmosis stabilization, with associated DL injury (bimalleolar equivalent). Patients with associated posterior or medial malleolus fractures, Weber B or A fractures, fibula fixation constructs other than plate and screws, follow-up less than 12 months, and revisions were excluded. Those meeting the inclusion criteria were split into 2 groups: DL repair vs no repair. Collected data included patient demographics, surgical procedures performed, and outcome measures. Primary outcomes measured postoperative oblique MCS and valgus talar tilt angle (TTA). Secondary outcomes included fracture union, complications, and patient-reported outcome measures (PROMs).

RESULTS: Seventy-seven fractures were included; 48 underwent DL repair whereas 29 did not. The mean follow-up was 28.9 months. Most study outcomes within each group had a statistically significant postoperative improvement. The valgus TTA in the repair vs no repair groups was 0.1 ± 0.9 vs 1.3 ± 2.0 degrees, respectively (P < .001). The MCS in the repair vs no repair groups was 3.5 ± 0.6 vs 3.8 ± 1.3 mm, respectively (P = .169). There were statistically significant differences in favor of DL repair in postoperative Veterans RAND-12 Item Health Survey physical subscale (P = .025) and Foot and Ankle Ability Measure activities of daily living subscale (P = .044) scores. There were no complications or revision surgeries directly related to DL repair.

CONCLUSION: The DL repair group had superior functional outcomes and ankle coronal plane alignment in comparison to no repair. There were no complications or revisions related directly to the deltoid repair. These results support consideration of DL repair in bimalleolar equivalent Weber C ankle fractures to improve functional outcomes and coronal plane alignment.

PMID:40947422 | DOI:10.1177/10711007251361122

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Nevin Manimala Statistics

Power and Sample Size Calculation for Multivariate Longitudinal Trials Using the Longitudinal Rank Sum Test

Stat Med. 2025 Sep;44(20-22):e70261. doi: 10.1002/sim.70261.

ABSTRACT

Neurodegenerative diseases such as Alzheimer’s and Parkinson’s often exhibit complex, multivariate longitudinal outcomes that require advanced statistical methods to comprehensively evaluate treatment efficacy. The Longitudinal Rank Sum Test (LRST) offers a nonparametric framework to assess global treatment effects across multiple longitudinal endpoints without requiring multiplicity corrections. This study develops a robust methodology for power and sample size estimation specific to the LRST, integrating theoretical derivations, asymptotic properties, and practical estimation techniques under large sample conditions. Validation through numerical simulations demonstrates the accuracy of the proposed methods, while real-world applications to clinical trials in Alzheimer’s disease (AD) and Parkinson’s disease (PD) highlight their practical significance. This framework facilitates the design of efficient, well-powered trials, advancing the evaluation of treatments for complex diseases with multivariate longitudinal outcomes.

PMID:40947402 | DOI:10.1002/sim.70261

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Nevin Manimala Statistics

Influence of digital crown design software on morphology, occlusal characteristics, fracture force and marginal fit

Dent Mater. 2025 Sep 13:S0109-5641(25)00761-4. doi: 10.1016/j.dental.2025.09.003. Online ahead of print.

ABSTRACT

OBJECTIVES: The study evaluated the influence of digital design software on crown morphology, occlusal characteristics, fracture force, and marginal fit across varying preparation designs for an identical target tooth.

METHODS: A resin-based tooth (tooth 36) was digitized, manufactured (n=8), individually prepared and re-digitized. Five design groups were established using conventional software proposals, technician designs, two AI-based software solutions, and natural tooth-based reference designs. All systems employed consistent parameters. Crown designs were digitally assessed using quantitative morphological and occlusal metrics in reference to the original tooth. Crowns were milled, marginal fit was measured via digital microscopy, and fracture resistance was determined after thermal cycling and mechanical loading.

RESULTS: Morphological metrics revealed statistically significant deviations across groups, with the technician design achieving the best performance. Occlusal metrics showed high deviations in the positional accuracy of the contact points across all groups. Technician and AI-based designs exhibited comparable functional results. None of the design groups were able to achieve contact with all relevant antagonist teeth, due to high deviations in the mesiolingual cusp. Conventional software designs exhibited the lowest fracture forces. Significant improvements were achieved through technician intervention. Vertical marginal discrepancies remained comparable across groups.

SIGNIFICANCE: Improved functional and morphological design combined with high fracture resistance can reduce the need for clinical adjustments, minimize wear, and enhance crown longevity. Digital design software significantly influences crown morphology, occlusal characteristics and fracture forces. Vertical marginal discrepancies remain similar. AI-driven approaches demonstrate comparability with technician designs in terms of fracture forces, functional performance, and marginal fit.

PMID:40947383 | DOI:10.1016/j.dental.2025.09.003

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Nevin Manimala Statistics

Characterization of the Tumor Immune Microenvironment in HER2-Positive Colorectal Cancer: Association With Prognostic and Therapeutic Implications

Clin Colorectal Cancer. 2025 Aug 20:S1533-0028(25)00072-6. doi: 10.1016/j.clcc.2025.08.004. Online ahead of print.

ABSTRACT

BACKGROUND: The human epidermal growth factor receptor 2 (HER2) status has been proposed as a biomarker to identify colorectal cancer (CRC) patients suitable for anti-HER2 treatment. However, response varies from HER2-negative CRC, influenced by factors such as the tumors immune microenvironment (TIME) in HER2-positive CRC patients. We aimed to characterize the TIME of HER2-positive CRC by assessing the associations of inflammatory cells and prognosis.

METHODS: TIME was characterized through immunostaining for CD3, CD4, CD8, CD20, CD68, Forkhead box protein P3 (Foxp3), and programmed death-ligand 1 (PD-L1) cell densities in 36 HER2-positive and 72 HER2-negative CRC patients. HER2 positivity was evaluated by the HERACLES criteria. PD-L1 expression was evaluated by the tumor proportion score (TPS) and combined proportion score (CPS).

RESULTS: In our study, the densities of CD3, CD4, CD8, CD20, CD68, Foxp3 cells and PD-L1 expression showed no statistic differences in HER2-positive CRC patients compared to HER2-negative patients. There was a greater proportion of Foxp3+ cells (≥ 10%) among patients with HER2-positive CRC (P = .023). Although the PD-L1 CPS was correlated with sex (P = .012), inflammatory cells and the PD-L1 TPS were not correlated with clinicopathological parameters. Additionally, CRC patients with PD-L1 CPSs ≥ 1 had significantly better event-free survival (EFS) than patients with PD-L1 CPSs < 1 (P = .029). For patients with HER2-positive CRC, higher CD68 indicated better EFS (P = .047).

CONCLUSIONS: This study characterized a preliminary immune microenvironment profile and indicated CD68 increased correlation with EFS for HER2-positive CRC patients. These immune microenvironment profiles and prognostic implications could serve as potential biomarkers for stratifying patients with HER-2 positive for clinical trials.

PMID:40947372 | DOI:10.1016/j.clcc.2025.08.004

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Nevin Manimala Statistics

Comparing DeepSeek and GPT-4o in ECG interpretation: Is AI improving over time?

Heart Lung. 2025 Sep 13:S0147-9563(25)00182-7. doi: 10.1016/j.hrtlng.2025.08.007. Online ahead of print.

ABSTRACT

BACKGROUND: DeepSeek is a recently launched large language model (LLM), whereas GPT-4o is an advanced ChatGPT version whose electrocardiography (ECG) interpretation capabilities have been previously studied. However, DeepSeek’s performance in this domain remains unexplored.

OBJECTIVES: This study aims to evaluate DeepSeek’s accuracy in ECG interpretation and compare it with GPT-4o, emergency medicine specialists, and cardiologists. A secondary aim is to assess any performance changes in GPT-4o over one year.

METHODS: Between February 9 and March 1, 2025, 40 ECG images (20 daily routine, 20 more challenging) from the book 150 ECG Cases were evaluated by both GPT-4o and DeepSeek, each model tested 13 times. The accuracy of their responses was compared with previously collected answers from 12 cardiologists and 12 emergency medicine specialists. GPT-4o’s 2025 performance was compared to its 2024 results on identical ECGs.

RESULTS: GPT-4o outperformed DeepSeek with higher median correct answers on daily routine (14 vs. 12), more challenging (13 vs. 10), and total ECGs (27 vs. 22) with statistically significant differences (p=0.048, p<0.001, p<0.001). A moderate agreement was observed between the responses provided by GPT-4o (p<0.001, Fleiss Kappa=0.473), while a substantial agreement was observed in the responses provided by DeepSeek (p<0.001, Fleiss Kappa=0.712). No significant year-over-year improvement was observed in GPT-4o’s performance.

CONCLUSION: This first evaluation of DeepSeek in ECG interpretation reveals its performance is lower than that of GPT-4o and human experts. While GPT-4o demonstrates greater accuracy, both models fall short of expert-level performance, underscoring the need for caution and further validation before clinical integration.

PMID:40947358 | DOI:10.1016/j.hrtlng.2025.08.007