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Nevin Manimala Statistics

What can we learn from 68 000 clinical frailty scale scores? Evaluating the utility of frailty assessment in emergency departments

Age Ageing. 2025 Mar 28;54(4):afaf093. doi: 10.1093/ageing/afaf093.

ABSTRACT

BACKGROUND: Emergency departments (EDs) in England are under significant strain, with increasing attendances and extended wait times, affecting frail older adults. The clinical frailty scale (CFS) has been implemented as a tool to assess frailty in ED settings, but its reliability and predictive accuracy as a screening tool remain debated.

OBJECTIVE: To evaluate the use and variability of the CFS in EDs and its association with patient outcomes, including discharge rates, length of stay, readmission and mortality.

METHODS: A retrospective cohort study of ED attendances at two London (UK) hospitals from 2017 to 2021. Data included CFS scores, demographics, clinical observations and outcomes. Comparative statistics, logistic regression, Cox proportional hazards models and competing risk regression were applied to examine CFS predictive validity.

RESULTS: In a sample of 123 324 ED visits, CFS scores strongly correlated with adverse outcomes: e.g. for long-term mortality (n = 33 475, events = 8871), each CFS single-point increase was associated with a 25% increase in mortality risk (95% CI 1.23-1.26). CFS scores varied significantly between raters and across visits, median difference two levels (interquartile range 1-3). Intraclass correlation coefficient analysis showed that 33.1% of CFS score differences was attributable to between-patient differences, 15.4% to inter-rater differences, with 51.5% residual variance from non-frailty factors, such as acute illness severity.

CONCLUSION: The CFS is associated with crucial patient outcomes in the ED. Inter-rater variability and potentially confounding factors can limit its consistency. Automation to enhance CFS score reliability should be explored as a means to support proactive management.

PMID:40253684 | DOI:10.1093/ageing/afaf093

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Nevin Manimala Statistics

Impact of prior robotic surgical expertise on the results of Hugo RAS radical prostatectomy: a propensity score-matched comparison between Da Vinci-expert and non-Da Vinci-expert surgeons

World J Urol. 2025 Apr 20;43(1):236. doi: 10.1007/s00345-025-05608-2.

ABSTRACT

BACKGROUND: Hugo RAS is a novel robotic platform gaining global adoption. Most reported outcomes come from centers with prior Da Vinci experience, with limited data from robotic-naïve settings or comparisons based on prior robotic expertise.

OBJECTIVE: To compare outcomes of Hugo RAS robot-assisted radical prostatectomy (RARP) performed by Da Vinci-experienced (DVE) versus non-Da Vinci-experienced (NDVE) surgeons.

DESIGN, SETTING, AND PARTICIPANTS: Prospective data from patients undergoing Hugo-RARP (July 2022-November 2024) were analyzed. Patients were grouped based on whether their surgeon had prior Da Vinci experience. None had prior Hugo-RAS experience.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcomes were positive surgical margin (PSM) and complication rates. Secondary outcomes included operative time (OT), estimated blood loss (EBL), length of stay (LOS), continence, and potency. Propensity score matching adjusted for baseline differences.

RESULTS AND LIMITATIONS: After matching, 117 patients per group were analyzed. PSM rates (17% vs. 21%; p = 0.40) and complications (p = 0.63) were similar. DVE surgeons had shorter OT (179 vs. 206 min; p < 0.001) and lower EBL (127 vs. 161 ml; p = 0.008). LOS did not differ (p = 0.84), and 12-month functional and oncological outcomes were comparable. Limitations include the non-randomized, single-center design.

CONCLUSIONS: Hugo RAS enables safe and effective RARP with comparable outcomes regardless of prior robotic experience. Prior Da Vinci experience, however, improves intraoperative efficiency.

PMID:40253671 | DOI:10.1007/s00345-025-05608-2

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Nevin Manimala Statistics

Characteristics, Treatment, and Survival of Male Breast Cancer: A 21-year Retrospective Analysis at a Community Academic Institute in Central Illinois

Cancer Control. 2025 Jan-Dec;32:10732748251335365. doi: 10.1177/10732748251335365. Epub 2025 Apr 20.

ABSTRACT

Introduction: Male breast cancer is an uncommon disease, representing a fraction of all breast cancer diagnoses. This study examines the characteristics, treatment, and outcomes of males with breast cancer at a community academic institute in central Illinois.Methods: We retrospectively reviewed the medical records of male patients with breast cancer treated between 2000 and 2021. This review focuses on patient demographics, tumor characteristics, treatment modalities, and recurrence and survival rates. We evaluated the association of epidemiological factors and clinical outcomes with patient age, tumor stage, and grade, as well as tumor hormone receptor status.Results: Our study included 81 male patients, predominantly white, with a median age of 67 years. Most cases presented estrogen receptor-positive (96.1%) and progesterone receptor-positive (93.5%) tumors, while only 13.5% had HER-2 neu receptor-positive expression. Staging distribution was 34.6% at Stage I, 47.4% at Stage II, and 17.9% at Stages III/IV among 78 patients. Recurrence occurred in 20.8% of 77 patients, with a 5-year recurrence-free survival rate of 76.2%. The 5-year overall survival rate of all 81 patients was 63.4%. Age and disease stage were significantly associated with mortality (P = .041 and P = .0028, respectively).Conclusion: Our findings align with national trends in male breast cancer demographics and outcomes, with comparable survival statistics. Increased awareness and targeted research are critical to improving management and prognosis for this patient population. Further studies are necessary to elucidate the molecular basis of male breast cancer and to refine treatment guidelines.

PMID:40253653 | DOI:10.1177/10732748251335365

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Nevin Manimala Statistics

The assessment of mood in people with severe cognitive and communication impairments following brain injury: a survey of UK-based professionals

Brain Inj. 2025 Apr 20:1-16. doi: 10.1080/02699052.2025.2493354. Online ahead of print.

ABSTRACT

AIM: Assessing mood via standardized measures and clinical interviews is challenging in people with ongoing cognitive and receptive communication impairments after a severe brain injury. This study examined how healthcare professionals in the United Kingdom assess this population via two online surveys, one of clinical psychologists (CPs) and one of medical professionals (MPs).

METHOD: Recruitment was completed via social media and invitational e-mails to identified services, professional bodies and special interest groups. Survey responses were via multiple choice and free text. Responses were analyzed using descriptive statistics and content analysis.

RESULTS: 55 CPs and 29 MPs responded. All respondents reported asking others about the patient’s mood, and the majority of both groups interview and observe the patient. 86% of CPs and 45% of MPs use standardized measures. Most of the CPs made adaptations to the measures, as did more than a third of MPs. The majority of both groups made adaptations to the scores.

CONCLUSIONS: Most clinicians assessing mood in this population ask others about the person. Mood measures are used, but the administration and score interpretation are frequently adapted, bringing the validity of the use of measures in this population into question. Although there was overlap regarding methods used by surveyed clinicians, there was no clear consensus on how mood should be assessed in this population.

PMID:40253652 | DOI:10.1080/02699052.2025.2493354

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Nevin Manimala Statistics

Geographic remoteness-based differences in in-hospital mortality among people admitted to NSW public hospitals with heart failure, 2002-21: a retrospective observational cohort study

Med J Aust. 2025 Apr 21;222(7):348-355. doi: 10.5694/mja2.52635.

ABSTRACT

OBJECTIVE: To examine associations between remoteness of region of residence and in-hospital mortality for people admitted to hospital with heart failure in New South Wales during 2002-21.

STUDY DESIGN: Retrospective observational cohort study; analysis of New South Wales Admitted Patient Data Collection data.

SETTING, PARTICIPANTS: Adult (16 years or older) NSW residents admitted with heart failure to NSW public hospitals, 1 January 2002 – 30 September 2021. Only first admissions with heart failure during the study period were included.

MAIN OUTCOME MEASURES: In-hospital mortality, by remoteness of residence (Australian Statistical Geography Standard), adjusted for age (with respect to median), sex, socio-economic status (Index of Relative Socioeconomic Advantage and Disadvantage [IRSAD], with respect to median), other diagnoses, hospital length of stay, and calendar year of admission (by 4-year group).

RESULTS: We included 154 853 admissions with heart failure; 99 687 people lived in metropolitan areas (64.4%), 41 953 in inner regional areas (27.1%), and 13 213 in outer regional/remote/very remote areas (8.5%). The median age at admission was 80.3 years (interquartile range [IQR], 71.2-86.8 years), and 78 591 patients were men (50.8%). The median IRSAD score was highest for people from metropolitan areas (metropolitan: 1000; IQR, 940-1064; inner regional: 934; IQR, 924-981; outer regional/remote/very remote areas: 930; IQR, 905-936). During 2002-21, 9621 people (6.2%) died in hospital; the proportion was 8.0% in 2002, 4.9% in 2021. In-hospital all-cause mortality was lower during 2018-21 than during 2002-2005 (adjusted odds ratio [aOR], 0.52; 95% confidence interval [CI], 0.49-0.56); the decline was similar for all three remoteness categories. Compared with people from metropolitan areas, the odds of in-hospital death during 2002-21 were higher for people from inner regional (aOR, 1.12; 95% CI, 1.07-1.17) or outer regional/remote/very remote areas (aOR, 1.35; 95% CI, 1.25-1.45).

CONCLUSION: In-hospital mortality during heart failure admissions to public hospitals declined across NSW during 2002-21. However, it was higher among people living in regional and remote areas than for people from metropolitan areas. The reasons for the difference in in-hospital mortality should be investigated.

PMID:40253641 | DOI:10.5694/mja2.52635

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Nevin Manimala Statistics

Prevalence of allergic rhinitis in children aged 6 to 10 years treated in the Allergy service

Rev Alerg Mex. 2025 Mar 30;72(1):21-27. doi: 10.29262/ram.v72i1.1426.

ABSTRACT

OBJECTIVE: Determine the prevalence of allergic rhinitis in school children.

METHODS: Cross-sectional, descriptive study in children from 6 to 10 years old. Those who underwent skin testing (mites, pollens, fungi, cockroach, dog and cat hair) were included. The diagnosis of allergic rhinitis was made based on the test recommended by the European Academy of Allergy and Clinical Immunology (EAACI) and the American College of Allergy, Asthma and Immunology (ACAAI) for the diagnosis of allergy mediated by allergen-specific IgE. The statistical analysis included confidence interval for averages and percentages.

RESULTS: In the 992 patients, the prevalence of allergic rhinitis was 15.7% (95% CI; 13.4-18.0), the predominant symptom was hyaline rhinorrhea in 94.7% (95% CI; 91.4-94.6), the main allergen was dust mites 60.4% (95% CI; 52.7-68.1) and pollen 59.3% (95% CI; 51.6-67.0).

CONCLUSION: The prevalence of allergic rhinitis in school children with positive skin tests is 15.7%, with a predominance of males with 63.1%.

PMID:40253632 | DOI:10.29262/ram.v72i1.1426

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Nevin Manimala Statistics

Frequency of signs and symptoms in the Post-COVID Syndrome of subjects partially or fully recovered from COVID-19

Rev Alerg Mex. 2025 Mar 30;72(1):8-13. doi: 10.29262/ram.v72i1.1388.

ABSTRACT

OBJETIVES: To evaluate the persistent symptoms in subjects with infection of COVID-19, partially or fully recovered.

METHODS: An observational, descriptive, cross-sectional, prospective study was conducted in individuals who were infected with SARS-CoV-2. We included Individuals of any gender and age who voluntarily answer a survey after developing infection to identify signs and symptoms associated, we analyzed whether there was any relationship between female sex and obesity, or age related with post-COVID-19 syndrome by X2 test and t Student test.

RESULTS: 197 individuals were included with mean age 41.57 (SD 14.2 years), 61.9% were female. Post-COVID syndrome was present in 52.3%, depression, anosmia, dysgeusia, nausea, alopecia and behavior disorders were greater in women; arthralgia, dyspnea, cough, and odynophagia were greater in obesity being statistically significant (p<0.05).

CONCLUSIONS: Post-COVID syndrome was found in 52.3%, with a variety of symptoms female sex had a higher risk of presenting post-Covid syndrome with symptoms such as depression, behavior disorders, anosmia, and baldness.

PMID:40253630 | DOI:10.29262/ram.v72i1.1388

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Nevin Manimala Statistics

Novel machine learning approach to differential cell flow cytometry analysis based on projection pursuit

J Biopharm Stat. 2025 Apr 20:1-13. doi: 10.1080/10543406.2025.2490725. Online ahead of print.

ABSTRACT

This paper introduces the novel methodology of differential projection pursuit and its applications to the analysis of large datasets. The method was applied to a cell flow cytometry dataset as an alternative approach to analyze this type of data. Multicolor cell flow cytometry is a well-established laboratory technique to identify cell subpopulations by measuring their physical and biochemical characteristics. Differential projection pursuit helps to find regions with maximal differences between two or more treatments or distributions. Data analysis in flow cytometry relies on gating, the process of manually selecting successive subpopulations of cells using two-dimensional plots. Plotting the variables only two at a time could mask the hidden structure present in the data, and manual selection makes the analysis inconsistent and arbitrary. The new methodology could automate flow cytometry analysis by utilizing the combination of projection pursuit, data nuggets, and factor analysis. When applied to flow cytometry data, differential projection pursuit allows researchers to quickly identify differences in cell populations exposed to different experimental conditions. This methodology could create a platform to explore differences in large datasets and improve the cell flow cytometry analysis clarity and reproducibility by considering the data in its true dimensional space and through automation, respectively.

PMID:40253621 | DOI:10.1080/10543406.2025.2490725

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Nevin Manimala Statistics

Biomarker-guided adaptive enrichment design with threshold detection for clinical trials with time-to-event outcome

J Biopharm Stat. 2025 Apr 20:1-18. doi: 10.1080/10543406.2025.2489291. Online ahead of print.

ABSTRACT

Biomarker-guided designs are increasingly used to evaluate personalized treatments based on patients’ biomarker status in Phase II and III clinical trials. With adaptive enrichment, these designs can improve the efficiency of evaluating the treatment effect in biomarker-positive patients by increasing their proportion in the randomized trial. While time-to-event outcomes are often used as the primary endpoint to measure treatment effects for a new therapy in severe diseases like cancer and cardiovascular diseases, there is limited research on biomarker-guided adaptive enrichment trials in this context. Such trials almost always adopt hazard ratio methods for statistical measurement of treatment effects. In contrast, restricted mean survival time (RMST) has gained popularity for analyzing time-to-event outcomes because it offers more straightforward interpretations of treatment effects and does not require the proportional hazard assumption. This paper proposes a two-stage biomarker-guided adaptive RMST design with threshold detection and patient enrichment. We develop sophisticated methods for identifying the optimal biomarker threshold and biomarker-positive subgroup, treatment effect estimators, and approaches for type I error rate, power analysis, and sample size calculation. We present a numerical example of re-designing an oncology trial. An extensive simulation study is conducted to evaluate the performance of the proposed design.

PMID:40253620 | DOI:10.1080/10543406.2025.2489291

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Nevin Manimala Statistics

Joint modeling of longitudinal endpoints and its applications to trial planning, monitoring and analysis

J Biopharm Stat. 2025 Apr 20:1-15. doi: 10.1080/10543406.2025.2489280. Online ahead of print.

ABSTRACT

In the context of clinical trial practices, the study power and sample size are typically determined based on the expected treatment effects on the primary endpoint collected over time. The utilization of longitudinal modeling for the primary endpoint offers a flexible approach that has the potential to reduce the sample size and duration of the trial, thereby improving operational efficiency and costs. Joint modeling of multiple endpoints presents a unique opportunity to understand how the primary endpoint evolves over time with other clinically important endpoints, and has the potential to increase precision of estimates and therefore increase study power when designing a study at planning stage and enhance understanding and interpretation of the data at a multi-dimensional level at the analysis stage. This approach enables a comprehensive evaluation of clinical evidence from various perspectives, rather than relying solely on isolated pieces of information. Joint modeling of multiple longitudinal endpoints would also help trial monitoring process as the trial accumulates clinical evidence of efficacy data, and there is a high demand in developing tools for statistical learning the treatment benefits on the go especially when the endpoint(s) is not well-established yet in some therapeutic indications. In this article, we will illustrate the use of joint modeling of longitudinal endpoints and its applications to study design, analysis, and trial monitoring practices. Simulation studies suggest that the potential efficiency gain would be achieved via leveraging information within endpoint over time and/or between endpoints. We developed an R shiny application to aid in and support identifying promising efficacy signals from endpoints under investigation during the trial monitoring. The implementation of the joint models and the added values will be discussed through case studies and/or simulation studies.

PMID:40253614 | DOI:10.1080/10543406.2025.2489280