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Nevin Manimala Statistics

Best Systemic Therapy With or Without Radical Prostatectomy in the Management of Men With Oligometastatic Prostate Cancer: The RAMPP Randomised Controlled Trial

Eur Urol. 2025 Oct 3:S0302-2838(25)04687-1. doi: 10.1016/j.eururo.2025.09.4144. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Our aim was to evaluate the effect of addition of radical prostatectomy (RP) to best systemic therapy (BST) on cancer-specific mortality (CSM) in patients with oligometastatic prostate cancer (omPC).

METHODS: This randomised controlled trial included patients with omPC with a low metastatic burden (1-5 bone metastases with/without nodal involvement) on conventional or PET imaging. Patients were randomised to receive either RP with pelvic lymph-node dissection plus BST (RP + BST) or BST alone. The primary endpoint was CSM. Secondary endpoints included clinical progression and overall survival (OS). Study accrual was stopped early because of a change in medical practice. Statistical analyses included cumulative incidence plots, Gray’s test, competing-risks regression, Kaplan-Meier estimates, and log-rank tests.

KEY FINDINGS AND LIMITATIONS: Between May 2015 and December 2018, 132 patients were randomised. The median age was 67 yr (interquartile range 63-71) and median prostate-specific antigen was 20 ng/ml (interquartile range 10-39). The 5-yr CSM cumulative incidence was 13% for RP + BST and 23% for BST alone (p = 0.037), with a hazard ratio of 0.39 (95% confidence interval 0.16-0.98; p = 0.045). The 5-yr cumulative incidence of clinical progression including CSM was 59% for RP + BST and 60% for BST alone. The 5-yr OS rate was 81% for RP + BST and 74% for BST alone. Clavien-Dindo grade ≥III surgery-related complications occurred in nine of 66 (14%) patients in the RP + BST arm. Limitations include early discontinuation of study accrual and the lack of statistical significance for the OS benefit.

CONCLUSIONS AND CLINICAL IMPLICATIONS: While this trial has substantial limitations, the results support addition of RP as local therapy to BST in omPC. This trial is registered on ClinicalTrials.gov as NCT02454543.

PMID:41046179 | DOI:10.1016/j.eururo.2025.09.4144

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Nevin Manimala Statistics

The impact of an institutional sepsis guideline on selecting appropriate empirical treatment in patients with carbapenem-resistant gram-negative bacilli bacteremia

Eur J Clin Microbiol Infect Dis. 2025 Oct 4. doi: 10.1007/s10096-025-05276-5. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to investigate the impact of our institutional sepsis protocol on the empirical treatment of carbapenem-resistant Gram-negative bacteria in a setting where infectious disease consultation (ID) is available 7 days / 24 h and broad-spectrum antibiotic use requires ID approval.

METHODS: A total of 612 patients (168 patients pre-guideline, 444 patients post-guideline) who received empirical antibiotics for suspicion of sepsis before documentation of antibacterial susceptibility were included. Demographic, clinical and microbiological data were collected from the hospital’s electronic medical record system, retrospectively. Compliance with institutional guidelines and the rate of appropriate antibiotic use prior to the availability of antibiograms were assessed.

RESULTS: There was a statistically significant increase in the utilization rate of empirical antibacterial treatment based on pre-defined risk factors of multidrug resistance [OR (95% CI) 1.73 (1.21-2.48), p = 0.003]. Furthermore, appropriateness of the initial antibacterial treatment according to the antibiogram results increased significantly in the post-guideline period [OR (95% CI) = 3.25 (2.09-5.06), p < 0.001]. The rate of compliance with guideline recommendations (p = 0.004) and the rate of appropriate empirical antibiotic treatment (p < 0.001) by each year were significant when compared with the pre-guideline period. Also, practices that improve drug pharmacokinetics such as loading dose, prolonged infusion of meropenem and adjusting antibiotic doses according to renal function increased statistically after the release of guideline.

CONCLUSION: An institutional sepsis protocol based on risk factors for multidrug resistance and local epidemiology increased the rate of appropriate empirical antibiotic treatment even in a setting where ID consultation is readily available.

PMID:41045444 | DOI:10.1007/s10096-025-05276-5

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Nevin Manimala Statistics

Association between legume consumption and risk of esophageal cancer among Chinese adults: a 17-year prospective cohort study

Cancer Causes Control. 2025 Oct 4. doi: 10.1007/s10552-025-02073-5. Online ahead of print.

ABSTRACT

PURPOSE: Epidemiological studies have reported the influence of legume consumption on multiple cancers risk, but the association in esophageal cancer (EC) remains unclear. This study aimed to investigated the prospective associations between legume consumption and EC risk, especially among Chinese populations.

METHODS: We conducted a prospective cohort study with 15,184 participants aged 40 to 69 years from two high-risk areas of EC in China between 2005 and 2009, with follow-up until 2022. A validated questionnaire was used to collect the consumption frequency of major food groups at baseline and subsequent resurveys, including legume. The Cox proportional hazard regression was used to evaluate the multivariable hazard ratios (HRs) and 95% confidence intervals (CIs) for the association of legume consumption and EC risk. To quantify the linear association of legume consumption and EC risk and to account for regression dilution bias, the mean usual consumption amount for each baseline group was estimated by combining the consumption level at both baseline and the second resurvey.

RESULTS: The final study sample included 15,184 participants in the cohort (mean [SD] baseline age, 51.8 [7.5] years). During a follow-up of 219,365 person-years, a total of 176 new EC cases were identified. Legume consumption was inversely associated with EC risk, with a 63% reduction in risk for participants who consumed legume regularly compared with nonconsumption (HR: 0.37; 95% CI 0.16, 0.84; p for trend = 0.022). After correction for regression dilution bias, each 10 g/day increased legume consumption was associated with a HR of 0.35 (0.13, 0.96) for esophageal squamous cell carcinoma (ESCC) risk. The associations were consistent across most subgroups and sensitivity analyses.

CONCLUSION: Higher frequency of legume consumption was associated with lower risk of EC among Chinese adults, particularly ESCC. Our findings suggest legume consumption may play an important role in preventing the development of EC.

PMID:41045426 | DOI:10.1007/s10552-025-02073-5

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Nevin Manimala Statistics

Critical appraisal of diagnostic criteria and statistical methodology in FALD study

Hepatol Int. 2025 Oct 4. doi: 10.1007/s12072-025-10920-5. Online ahead of print.

NO ABSTRACT

PMID:41045421 | DOI:10.1007/s12072-025-10920-5

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Nevin Manimala Statistics

Comparative efficacy and safety of tislelizumab and other programmed cell death protein 1 inhibitors in first-line treatment of advanced gastroesophageal cancers: a systematic review and network meta-analysis

Gastric Cancer. 2025 Oct 4. doi: 10.1007/s10120-025-01660-4. Online ahead of print.

ABSTRACT

BACKGROUND: Several programmed cell death protein-1 inhibitors are approved for the first-line treatment of advanced gastric/gastroesophageal junction cancer, including pembrolizumab, nivolumab and, more recently, tislelizumab. Since direct comparisons between these agents are lacking, advanced statistical modeling can be utilized to evaluate the relative efficacy and safety of tislelizumab compared with other first-line immunotherapy regimens in this indication.

METHODS: A systematic literature review was performed to identify and summarize published randomized controlled trials investigating first-line treatments in adult patients with unresectable, locally advanced, or metastatic human epidermal growth factor receptor 2-negative gastric/gastroesophageal junction cancer. Relevant trials were synthesized using a Bayesian network meta-analysis; fixed-effect models were conducted for all analyses. The network meta-analysis base case used the intent-to-treat populations for tislelizumab + chemotherapy and placebo + chemotherapy from RATIONALE-305.

RESULTS: Key comparators included nivolumab + chemotherapy (ATTRACTION-4, CheckMate 649), and pembrolizumab + chemotherapy (KEYNOTE-062, KEYNOTE-859). Tislelizumab + chemotherapy demonstrated similar efficacy compared with nivolumab + chemotherapy and pembrolizumab + chemotherapy for both overall survival and progression-free survival. Tislelizumab + chemotherapy was associated with significantly lower odds of grade ≥ 3 treatment-related adverse events compared with nivolumab + chemotherapy, and there were no statistically significant differences between tislelizumab + chemotherapy compared with pembrolizumab + chemotherapy.

CONCLUSION: Overall, these analyses suggest that tislelizumab + chemotherapy is similarly efficacious to pembrolizumab + chemotherapy and nivolumab + chemotherapy, and is associated with a similar or lower incidence of grade ≥ 3 treatment-related adverse events in the first-line treatment of gastric/gastroesophageal junction cancer.

PMID:41045401 | DOI:10.1007/s10120-025-01660-4

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Nevin Manimala Statistics

PSM-SMOTE: propensity score matching and synthetic minority oversampling for handling unbalanced microbiome data

Genes Genomics. 2025 Oct 4. doi: 10.1007/s13258-025-01688-x. Online ahead of print.

ABSTRACT

BACKGROUND: Predictive models using microbiome data often suffer from covariate imbalance and class imbalance, biasing results. Propensity Score Matching (PSM) balances covariates but reduces sample size, while borderline synthetic minority oversampling technique (borderline-SMOTE) oversamples minority classes but can generate uninformative examples.

OBJECTIVE: To develop and evaluate PSM-SMOTE, a novel hybrid sampling method that integrates PSM and borderline-SMOTE to handle both covariate and class imbalance in microbiome data.

METHODS: We developed PSM-SMOTE, a three-step hybrid sampling algorithm for microbiome data: (1) PSM at four caliper levels to balance covariates, (2) selection of at least ten robust differential markers via seven statistical tests with false discovery rate correction, and (3) application of borderline-SMOTE on the marker-based distance matrix to oversample minority classes. We evaluated PSM-SMOTE on three publicly available microbiome case-control datasets: pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and obesity, using logistic regression (LR), random forest (RF), and support vector machine (SVM) classifiers. Performance was assessed via area under the ROC curve (AUC).

RESULTS: PSM-SMOTE improved test AUCs in multiple model-dataset combinations compared with using PSM alone. Notably, for the RF model, PSM-SMOTE consistently enhanced AUC across nearly all oversampling settings in the PDAC and obesity cohorts. For the SVM model, PSM-SMOTE also achieved a significant AUC increase in the CRC cohort. For the LR model, PSM-SMOTE showed modest improvement under strict matching.

CONCLUSION: PSM-SMOTE effectively addresses dual imbalance in microbiome data and consistently enhances performance, providing a practical solution for imbalanced data analyses.

PMID:41045399 | DOI:10.1007/s13258-025-01688-x

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Nevin Manimala Statistics

Does SUFU’s best practice policy statement regarding antibiotic prophylaxis predict urinary tract infection after urodynamic study? : Evidence from a retrospective cohort

World J Urol. 2025 Oct 4;43(1):596. doi: 10.1007/s00345-025-05979-6.

ABSTRACT

PURPOSE: To validate the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Best Practice Policy Statement (BPPS) risk factors (RFs) for predicting urinary-tract infection (UTI) after urodynamic study (UDS) and to identify possible RFs that could better guide antibiotic prophylaxis.

METHODS: A retrospective cohort study included all adults undergoing UDS at a single institution. Patients with asymptomatic bacteriuria received a 3-day antibiotic course, while those without bacteriuria received no prophylaxis. The primary endpoint was a culture-confirmed UTI within 7 days. Regression analysis was performed to check SUFU BPPS RFs as predictors for post-UDS UTI.

RESULTS: Among 1666 patients (median age 68 years; 42% female), UTI occurred in 31 (1.9%). Abnormal GU anatomy was found as a predictor for post-UDS UTI (OR = 3.26, p = 0.033). Other examined RFs were not found to predict post-UDS UTI. More concise variables were identified as statistically significant predictors: hydronephrosis (OR = 4.98, p = 0.004), elevated post-void residual (PVR) (OR = 2.80, p = 0.011), and NLUTD due to neurologic disease (OR = 2.27, p = 0.042). In multivariate analysis, elevated PVR and NLUTD caused by neurologic disease remained independent predictors.

CONCLUSION: The current SUFU BPPS criteria exhibit limited accuracy for predicting post-UDS UTI. Our study emphasizes hydronephrosis, NLUTD caused by neurologic disease, and elevated PVR as predictors of post-UDS UTI. Updating prophylactic guidelines to incorporate these findings could enhance patient safety and antimicrobial stewardship without compromising infection control.

PMID:41045391 | DOI:10.1007/s00345-025-05979-6

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Nevin Manimala Statistics

Robot-assisted hysterectomy for endometrial cancer: is there a correlation between uterine diameters, pelvic volume, and surgical outcomes?

J Robot Surg. 2025 Oct 4;19(1):661. doi: 10.1007/s11701-025-02820-5.

ABSTRACT

Hysterectomy could be performed through a vaginal approach, laparotomy, or laparoscopy. Robotic surgery is a technique that can be defined as a particular type of laparoscopy, often used in interventions where microsurgery can help improve radicality and effectiveness. In choosing patients for the robotic technique, many characteristics could be studied to tailor the surgical choice. Our aim is to describe the anthropomorphic and radiological parameters linked to worse surgical outcomes for the potential stratification of patients in the preoperative decision about the type of surgery. In our center, the AOU Maggiore della Carità Hospital in Novara (Italy), 104 patients diagnosed with endometrial cancer and candidated for total hysterectomy, with various degrees of radicality, underwent robotic surgery. Patients’ anthropomorphic parameters, such as body mass index, and radiological imaging such as uterine size and pelvis diameter, were compared with the surgical outcomes such as operating times, complications as blood loss, subsequent emergency room visits, and the possible need for laparotomy conversion. Our ratios between pelvic depth and uterine anteroposterior diameter (PD/UAP) and between uterine volume and pelvic volume index (UV/PCI) showed statistically significant correlations with surgical time.

PMID:41045388 | DOI:10.1007/s11701-025-02820-5

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Nevin Manimala Statistics

Hydrogeochemical conceptualization of granitic-urban area for sustainable water resource management: a case study of Daejeon, Korea

Environ Geochem Health. 2025 Oct 4;47(11):476. doi: 10.1007/s10653-025-02771-8.

ABSTRACT

Groundwater is increasingly vital under growing demand and climate pressures, making its effective management essential for sustainable use. A thorough understanding of hydrogeochemical processes is therefore critical to secure water quality and guide resource development. This study develops a conceptual model of a granitic aquifer in Daejeon, Korea, representing a typical weathered-fractured system under mixed urban and green land-use conditions. An integrated approach was applied, combining conventional geochemical analysis, multivariate statistics, geochemical modeling, and strontium isotope tracing. The results highlight silicate weathering as the dominant control on groundwater chemistry, validated by 87Sr/86Sr ratios (~ 0.716). Mineral-water interactions explain nearly half of the observed variance, mainly through the weathering of silicate minerals to secondary clays, which promote ion exchange processes. Anthropogenic activities, particularly agriculture and land use, account for ~ 15% of the variation, indicating localized contamination risks in the lowland areas. The conceptual model, supported by natural tracers, demonstrates that groundwater evolves from a Ca-HCO3 type in recharge zones to mixed types, such as Ca(Na)-HCO3 and Ca-Cl, along downgradient flow paths. This hydrogeochemical evolution reflects the combined effects of progressive mineral weathering and superimposed anthropogenic influences.By capturing both natural processes and human impacts, this study advances the understanding of hydrogeochemical dynamics in granite-based aquifers. The proposed conceptual framework provides a basis for predicting groundwater evolution and emphasizes the urgent need for sustainable management of these vulnerable resources in rapidly urbanizing regions.

PMID:41045384 | DOI:10.1007/s10653-025-02771-8

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Nevin Manimala Statistics

Health utility book: A systematic review and meta-analysis of health utilities in gastric cancer

Support Care Cancer. 2025 Oct 4;33(10):907. doi: 10.1007/s00520-025-09993-7.

ABSTRACT

PURPOSE: The treatment landscape in gastric cancer has changed drastically over the last 15 years with surgical advancements and the introduction of new therapeutic agents and combinations. Despite the potential for improved survival, these new interventions can impact health-related quality of life (HRQoL). Our objective was to identify and synthesize health utility data for gastric cancer patients as part of the Health Utility Book (HUB) project.

METHODS: We searched MEDLINE, EMBASE, EconLit, and CINAHL from inception to March 2023 for original studies that reported health utility data for gastric cancer. Records were screened independently and in duplicate by two reviewers. Data on study design, patient characteristics, and health utilities were extracted using a standardized form. A random effects meta-analysis was conducted to synthesize health utilities by cancer stage. Heterogeneity was evaluated using the I2 statistic.

RESULTS: 600 health utilities from 3,405 respondents were identified across 19 studies. All studies were published between 2018 and 2022 and most were conducted in Asia (n = 12, 63.2%). The EQ-5D was the most common method of preference elicitation (n = 17, 89.5%), and health utilities ranged from 0.298 (SD 0.088) to 0.920 (SD 0.130). Mean health utilities from random effects models were 0.82 (95% Confidence Interval [CI] 0.76-0.88), 0.76 (95% CI 0.68-0.85), and 0.67 (95% CI 0.46-0.87) for early stage, advanced stage, and metastatic gastric cancer, respectively.

CONCLUSION: This systematic review provides a reference set of health utilities for gastric cancer, which can help understand HRQoL and facilitate the retrieval and selection of health utilities for economic evaluations.

PMID:41045334 | DOI:10.1007/s00520-025-09993-7