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First-line lenvatinib plus pembrolizumab versus chemotherapy for advanced endometrial cancer: 1-Year follow-up after final analysis of the ENGOT-en9/LEAP-001 phase 3 trial

Int J Gynecol Cancer. 2025 Nov 11;36(1):102795. doi: 10.1016/j.ijgc.2025.102795. Online ahead of print.

ABSTRACT

OBJECTIVE: The phase 3 ENGOT-en9/LEAP-001 trial (NCT03884101) comparing first-line lenvatinib+pembrolizumab with carboplatin+paclitaxel did not meet pre-specified statistical criteria for overall survival or progression-free survival in participants with advanced/recurrent endometrial cancer. We report results after an additional year of follow-up (overall median 54.5 [range; 46.5-69.0] months).

METHODS: Eligible participants were adult females with stage III to IV or recurrent, histologically confirmed endometrial cancer. Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and radiographically apparent disease per blinded independent central review was required. Participants were randomly allocated 1:1 to lenvatinib+pembrolizumab or chemotherapy (paclitaxel+carboplatin). The primary end points were overall survival and progression-free survival per RECIST version 1.1 by blinded independent central review. Secondary end points included objective response rate per RECIST version 1.1 by blinded independent central review and safety.

RESULTS: The median overall survival (95% confidence interval [CI]) was 30.9 (range; 25.4-37.6) months with lenvatinib+pembrolizumab versus 29.4 (range; 26.2-34.8) months with chemotherapy in mismatch repair-proficient endometrial cancer (hazard ratio [HR] 0.99, 95% CI 0.82 to 1.21), 37.9 (range; 32.2-43.0) versus 32.3 (range; 27.2-35.7) months in all-comers (HR 0.91, 95% CI 0.77 to 1.09), and not reached in either treatment group in mismatch repair-deficient endometrial cancer (HR 0.60, 95% CI 0.39 to 0.93]). Corresponding results for progression-free survival were 9.6 (range; 8.2-11.9) versus 10.2 (range; 8.4-10.5) months (HR 1.01, 95% CI 0.83 to 1.22), 12.5 (range; 10.3-15.1) versus 10.2 (range; 8.4-10.4) months (HR 0.92, 95% CI 0.77 to 1.10]), and 31.8 (22.5 to not reached) versus 9.0 (range; 8.2-17.1) months (HR 0.62, 95% CI 0.41-0.93). Objective response rates were 50.6% versus 54.7%, 55.7% versus 55.5%, and 72.0% versus 58.0%, respectively. No new safety signals were identified. The results were consistent with those at the final analysis.

CONCLUSIONS: The mismatch repair-proficient, all-comer, and mismatch repair-deficient populations continued to demonstrate antitumor activity for lenvatinib+pembrolizumab after an additional year of follow-up. These results should be interpreted with caution due to the exploratory nature of the analysis.

TRIAL REGISTRATION: ClinicalTrials.gov No. NCT03884101.

PMID:41494216 | DOI:10.1016/j.ijgc.2025.102795

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Waist-to-hip ratio measured with computed tomography as a predictor of surgical outcomes in minimally invasive procedures for early-stage endometrial cancer

Int J Gynecol Cancer. 2025 Nov 26;36(1):102828. doi: 10.1016/j.ijgc.2025.102828. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to determine if the waist-to-hip ratio, an emerging indicator of abdominal obesity, predicts poor outcomes, such as sentinel node mapping failure, post-operative complications, conversion to laparotomy, and increased operative time, in endometrial cancer surgery.

METHODS: This retrospective study included patients with apparent early-stage endometrial carcinoma who underwent minimally invasive surgery at the Mauriziano Umberto I Hospital in Turin, Italy from January 2021 to January 2025. The waist-to-hip ratio was calculated using pre-operative computed tomography scans with previously described methods. Two cohorts based on a waist-to-hip ratio cutoff of 0.85, as defined by the World Health Organization, were identified and compared with statistical tests as appropriate. Univariate and multi-variable linear regression models were fit to evaluate predictors of poor surgical outcomes.

RESULTS: A total of 151 patients were included in the study. Abdominal obesity, as defined by an abnormal waist-to-hip ratio, was identified in 127 patients (84%), of whom 62 also had obesity according to the body mass index. Patients with abnormal waist-to-hip ratios were significantly older (median: 69 vs 61 years; p = .03), had higher body mass index (median: 29 vs 21 kg/m2; p < .001), and had higher comorbidity rates (67.7% vs 33.3%; p < .001) than patients with normal ratios. Their surgical procedures were significantly longer (median: 196 vs 174 minutes; p = .01), although no differences in sentinel node mapping or post-operative complication rates were found. After adjusting for potential confounders including body mass index, an abnormal waist-to-hip ratio remained significantly associated with increased operative time, corresponding to an average increase of 22 minutes (adjusted β coefficient: 22; 95% confidence interval; 2.3-42; p = .03).

CONCLUSIONS: An abnormal waist-to-hip ratio was significantly associated with increased operative time during minimally invasive surgery for endometrial cancer, whereas body mass index was not. Further research is needed to determine the predictive potential of the waist-to-hip ratio for personalized surgical planning.

PMID:41494215 | DOI:10.1016/j.ijgc.2025.102828

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Exhaled Breath Analysis to Stratify Cardiovascular Risk Using Machine Learning Model: A Novel Frontier in Preventive Cardiology

J Breath Res. 2026 Jan 6. doi: 10.1088/1752-7163/ae33e0. Online ahead of print.

ABSTRACT

Despite major progress in diagnosis and treatment, cardiovascular disease (CVD) continues to be the leading cause of death worldwide, responsible for roughly 19.8 million lives lost each year. A key challenge in preventive cardiology is still the early detection of those at elevated risk of serious heart complications.&#xD;Aims: Assess the ability of the machine learning model to stratify CVD risk using exhaled breath analysis. &#xD;Materials and methods: A single-center study involved 80 participants with vs. without stress-induced myocardial perfusion defect. All participants underwent a single resting breath sample collection in PTR-TOF-MS-1000, single blood sample intake, and stress computed tomography myocardial perfusion imaging with vasodilation test. Statistical analyses were performed using Statistica 12 (StatSoft, Inc., 2014), IBM SPSS Statistics v29.0.1.1 (IBM Corp., 2024). The threshold for statistical significance was p < 0.05. Machine learning models were developed using Google Colab with Python 3. &#xD;Results: The gradient-boosting model demonstrated the best performance and was therefore selected for further evaluation. The model showed an AUC of 0.77 [95% CI; 0.4976 – 1.0000] to differentiate participants with low CVD risk, moderate risk 0.55 [95% CI; 0.3345 – 0.7875], and high risk 0.66 [95% CI; 0.3765 – 0.8661]. &#xD;Conclusion: The gradient boosting machine learning model provides initial evidence that rest exhaled breath analysis can differentiate cardiovascular risk strata through identifiable concentration patterns of specific volatile organic compounds. However, substantial challenges remain regarding model performance and the confounding effects of class imbalance within a limited sample.&#xD.

PMID:41494207 | DOI:10.1088/1752-7163/ae33e0

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Dosimetric comparability validation of small animal photon and neutron irradiations

J Radiol Prot. 2026 Jan 6. doi: 10.1088/1361-6498/ae33cd. Online ahead of print.

ABSTRACT

Crew members on missions beyond low-earth orbit (BLEO) receive considerable radiation doses, but the effects and relative biological effectiveness of many relevant types of irradiation, including neutrons with energies of hundreds of MeV, largely remain under-investigated. Such small animal irradiations can only be compared to respective photon irradiations if comparable doses can simultaneously be delivered to a variety of organs during both irradiations, despite the different underlying dose deposition patterns.&#xD;Method: To evaluate the dosimetric comparability of upcoming small animal neutron and photon irradiations, experimental depth-dose measurements were performed at the TRIUMF neutron facility (TNF) and the British Columbia Cancer Research Centre (BCCRC), using a neutron beam with energies of up to 450 MeV and a Cs-137 irradiator. The MOBY digital mouse phantom was used to perform Monte Carlo simulations of neutron and photon animal irradiations. Evaluated metrics included the ratio between the dose delivered to a variety of different organs (including lungs, brain, and heart) during neutron and photon irradiation. A sensitivity analysis including a variety of animal parameters (tissue elemental compositions and mass densities, animal size, and animal orientation) was performed, and the statistical significance (p < 0.05) of the dosimetric impact of uncertainties in simulation parameters was analyzed.&#xD;Results: During nominal simulations, differences in organ doses during neutron and photon irradiation were <9% in all organs except the lungs (13%), in agreement with the dosimetric measurements performed, which exhibited differences of up to ≈20% depending on depth. During sensitivity analysis, no investigated source of uncertainty had a statistically significant dosimetric impact. &#xD;Conclusion: Organ doses during simulated neutron and photon irradiations were found to be comparable for various organs. Investigated sources of uncertainties had no statistically significant impact. These findings are therefore expected to be robust to realistic variations in animal parameters during upcoming small animal irradiations.

PMID:41494205 | DOI:10.1088/1361-6498/ae33cd

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Impact of Age on Hospital Outcomes Following Minimally Invasive Posterior Lumbar Interbody Fusion: Retrospective Analysis of the Nationwide Inpatient Sample Database from 2016 to 2020

JMIR Med Inform. 2026 Jan 6;14:e76424. doi: 10.2196/76424.

ABSTRACT

BACKGROUND: Minimally invasive posterior lumbar interbody fusion (MIS-PLIF) is commonly performed to treat degenerative lumbar spinal conditions. Patients of advanced age often present with multiple comorbidities and reduced physiological reserves, influencing surgical risks and recovery. The growing aging population has led to a rising demand for care for older adults, posing significant challenges for health care systems worldwide.

OBJECTIVE: This study aimed to identify the associations between different age groups and MIS-PLIF outcomes.

METHODS: This study retrospectively analyzed data from the United States Nationwide Inpatient Sample collected between 2016 and 2020. Patients aged ≥60 years who underwent MIS-PLIF were eligible for inclusion in this study. Patients were categorized into age groups (60-69, 70-79, and ≥80 y). Logistic and linear regressions were used to determine the associations between the study variables and outcomes, including in-hospital mortality, complications, nonroutine discharge, and length of stay.

RESULTS: A total of 785 patients aged ≥60 (mean age 69.4, SD 0.2) years who underwent MIS-PLIF were included in the analysis, and 18.7% (147/785) experienced at least one complication. After adjustment, compared with patients aged 60 to 69 years, the risk of nonroutine discharge was significantly increased in patients aged 70 to 79 years (adjusted odds ratio 2.33, 95% CI 1.57-3.46; P<.001) and ≥80 years (adjusted odds ratio 4.79, 95% CI 2.64-8.67; P<.001). No significant differences in the risk of complications or length of hospital stay were observed across the age groups.

CONCLUSIONS: In older patients undergoing MIS-PLIF, advanced age is an independent predictor of nonroutine discharge. Furthermore, our findings suggest that age alone is not an independent risk factor for complications or extended hospital stays among older patients. These findings underscore that MIS-PLIF is a viable option for older patients, for whom extra attention may still be needed for postoperative care. Implementing age-stratified management for older patients undergoing MIS-PLIF may have important clinical policy implications.

PMID:41494180 | DOI:10.2196/76424

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General Practitioners’ Perspectives on Digital Health Applications for Mental Disorders and Their Prescribing Behavior: Mixed Methods Study

JMIR Ment Health. 2026 Jan 6;13:e78659. doi: 10.2196/78659.

ABSTRACT

BACKGROUND: The high number of mental disorders poses challenges for health care systems. In 2020, digital health applications (DHAs) were introduced in Germany as a new form of health care financed by the statutory health insurance. They aim to detect, monitor, treat, or alleviate disease, injury, or disability. DHAs for mental disorders (DHA-MD) intend to improve outpatient care for patients with mental disorders. However, evidence on general practitioners’ (GPs’) perspectives on DHA-MD and their prescribing behavior is limited.

OBJECTIVE: This study aimed to analyze GPs’ perspectives on DHA-MD and their prescribing behavior in the care of patients with mental disorders.

METHODS: A mixed methods study was conducted (January-October 2024), including a Germany-wide online survey and qualitative interviews with GPs and medical assistants (MAs). Sampling was conducted in collaboration with German research practice networks, which distributed the study invitation to their affiliated GPs. The questionnaire as well as the interview guides for GPs and MAs was developed by the study team according to the Consolidated Framework for Implementation Research. Descriptive analyses of prescribing behavior and perceived need (measured on an 11-point scale) for DHA-MD were conducted, followed by multivariate regression analyses to identify predictors of prescribing behavior and perceived need for DHA-MD. The interviews with GPs and MAs were analyzed using qualitative content analysis according to Mayring.

RESULTS: A sample of 149 GPs participated, and 12 GPs as well as 5 MAs were interviewed. The median prescription frequency of DHA-MD per quarter was 1, whereas the median estimated need was 3. Working in a half digitized and half paper-based practice (odds ratio 5.133, 95% CI 1.695-15.542) as well as working in a completely digitized practice (odds ratio 3.006, 95% CI 1.296-6.969) positively predicted the prescribing behavior. The duration of GPs’ medical practice (b=-0.057; P=.01) negatively predicted the perceived need, while working in a group practice (b=0.980; P=.02) positively predicted the perceived need for DHA-MD. In the interviews, GPs and MAs reported that they valued DHA-MD as a temporary or supplementary option for bridging waiting times for psychotherapy and considered their effectiveness to be highly dependent on indication and patient adherence. Reported barriers of GPs according to DHA-MD included lacking knowledge about DHA-MD, missing effectiveness studies, and difficulties integrating them into existing care processes.

CONCLUSIONS: GPs are reluctant to prescribe DHA-MD, as the need is considered to be low and their use is primarily seen as a temporary or supplementary treatment option rather than a stand-alone intervention. There are significant reasons for rejection and barriers that hinder prescription in primary care. Addressing these barriers and involving GPs as well as patients in future research are essential for the development of DHA-MD.

PMID:41494179 | DOI:10.2196/78659

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Catheter-Related Bloodstream Infections Among Critically Ill Patients With Central Vascular Access Devices: A Cross-Sectional Study in China

J Infus Nurs. 2026 Jan-Feb 01;49(1):52-68. doi: 10.1097/NAN.0000000000000624. Epub 2025 Dec 23.

ABSTRACT

OBJECTIVE: The aim of this study is to assess catheter-related bloodstream infections (CRBSIs) in Chinese intensive care units (ICUs), covering prevalence, risk factors, pathogen distribution, and impacts of outcome.

METHODS: A cross-sectional study was conducted in ICUs across 22 tertiary hospitals (2023-2024), with CRBSI diagnoses following Chinese national guidelines. Data were analyzed using R software (version 4.4.2), employing chi-square tests, robust Poisson regression, and Bayesian logistic regression (P < .05).

RESULTS: The prevalence of CRBSI was 1.19% (1.53/1000 catheter days, 32 patients, and 36 episodes). Risk factors included no formal education/illiteracy (OR: 1.995-9.604), circulatory diseases (OR: 1.142-5.787), complex/rare diseases (OR: 2.417-13.048), and multiple catheterizations (OR: 4.502-15.093). The subclavian vein was safest (femoral/axillary OR: 4.01-6.86). Gram-negatives predominated (47.22%). Each additional day of catheter dwell days increased CRBSI risk by 4.33% (95% CI: 3.04%-5.20%), and each additional ICU stay raised risk by 4.2% (95% CI: 2.9%-5.1%). CRBSI increased mortality (OR: 8.65), prolonged ICU stay (mean increase of 9.09 days), and additional costs (¥122 539.56 per case, approximately $17 505.65).

CONCLUSION: CRBSI significantly worsens outcomes and costs in Chinese ICUs. Prioritizing subclavian catheterization, infection prevention bundles, and gram-negative antimicrobial stewardship is essential. Further research is needed to validate these interventions across diverse settings.

PMID:41494177 | DOI:10.1097/NAN.0000000000000624

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Experience of Hospital Staff With Patients Who Self-Inject Drugs: A Survey-Based Study of the Impacts on Medical Care

J Infus Nurs. 2026 Jan-Feb 01;49(1):22-28. doi: 10.1097/NAN.0000000000000629. Epub 2025 Dec 23.

ABSTRACT

OBJECTIVES: The United States opioid crisis has led to significant health care challenges. Patients who inject drugs (PWID) may self-inject illicit substances into vascular access devices (SIVAD). This behavior can lead to complications, including overdose and death. Given lack of data on SIVAD, this study aims to survey hospital staff on experiences with PWID and SIVAD, assess effectiveness of current protocols, and highlight the underreporting of incidents and their impact on care.

METHODS: A cross-sectional survey study was conducted among hospital staff. The survey assessed experiences with SIVAD, perceptions, and suggestions for improvement. Analyses with descriptive statistics for quantitative data and thematic analysis for qualitative responses were performed.

RESULTS: Overall, 254 surveys were obtained. Of these, 31.7% (72/227) reported confirmed SIVAD during their care, and 48.6% (110/226) believed their patient did not complete care due to the stigma of SIVAD. Furthermore, 72.3% (68/94) reported altering care plans due to concern of SIVAD. Finally, 93.8% (212/226) of respondents stated that they would use a device to mitigate SIVAD, if available.

CONCLUSION: By surveying hospital staff about their experience with SIVAD, this study highlights the impact and underreporting of this issue. This study also underscores the need for enhanced patient safety in cases of SIVAD and desire for new protocols and devices to improve care quality.

PMID:41494173 | DOI:10.1097/NAN.0000000000000629

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Peripheral Vasopressor Administration in Adults With Sepsis: A Retrospective Study of Guideline Adherence and Complications

J Infus Nurs. 2026 Jan-Feb 01;49(1):13-21. doi: 10.1097/NAN.0000000000000626. Epub 2025 Dec 23.

ABSTRACT

BACKGROUND: Peripheral intravenous catheter (PIVC) vasopressor administration is increasingly used to expedite the treatment of septic shock when central venous access is not immediately available. This shift in practice reflects growing support from national guidelines, which permit short-term peripheral administration of vasopressors in adults. On March 9, 2023, hospitals within 1 health care system implemented guidelines for PIVC vasopressor administration in adult critical care settings, specifically emergency departments and intensive care units.

OBJECTIVE: This study examined adherence to these guidelines for PIVC vasopressor use and to identify associated complications.

METHODS: This retrospective descriptive study included 106 adult patients (68 emergency department and 38 intensive care unit patients) diagnosed with sepsis and receiving peripheral vasopressors.

RESULTS: The majority of patients received norepinephrine through a short PIVC. Overall, 5 patients (4.7%) experienced complications, 4 with thrombophlebitis and 1 with an extravasation. All 5 patients received norepinephrine at the organization’s policy-specified concentration via short PIVCs. However, only 1 of these patients met the system’s guidelines for minimum PIVC size, quantity, and maximum infusion duration. Overall, only 58% of patients were managed in full compliance with the system’s guidelines.

CONCLUSION: These results support the use of standardized protocols to reduce complications associated with short-term peripheral vasopressor administration.

PMID:41494172 | DOI:10.1097/NAN.0000000000000626

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Attitudes Toward Video Consultations From the Perspective of Physicians and Psychotherapists in German Outpatient Care After the COVID-19 Pandemic: Survey Study

J Med Internet Res. 2026 Jan 6;28:e73757. doi: 10.2196/73757.

ABSTRACT

BACKGROUND: Although video consultations (VCs) are permitted in German outpatient care and have seen a notable rise during the COVID-19 pandemic, their use still does not seem to have become established in Germany.

OBJECTIVE: This survey aims to evaluate the attitudes of physicians and psychotherapists with regard to the use of VC after the COVID-19 pandemic, in particular in the context of types of treatment and suitable medical fields.

METHODS: A standardized questionnaire was sent out to all 34,095 physicians and psychotherapists in 4 German regions. The analysis consisted of both descriptive and inferential statistics. Subgroup analysis included gender, age groups, community size of practice location, VC experience, type and ownership of practice, and area of medical care. Binary logistic regression was conducted to determine whether physicians’ and psychotherapists’ individual factors, organizational factors, or area of medical care were associated with at least monthly VC provision or interest in VC provision.

RESULTS: The response rate was 17.9%, including a total of 5930 participants in the analysis. About 40% (2216/5863) of the physicians and psychotherapists surveyed stated that they offer VC at least once a month. In the area of medical care, the odds ratio (OR) of at least monthly VC provision in psychotherapeutic care was about 8.2 (95% CI 7.4-1.64; P<.001) compared to primary care, whereas in specialist care, the odds for monthly VC provision were approximately 50% lower than in primary care (OR 0.5, 95% CI 0.43-0.59; P<.001). Further, female participants have higher odds to provide VC at least once a month (OR 1.163, 95% CI 1.01-1.34; P=.03). The odds for monthly VC provision in older age groups are approximately 60% higher than in the <40 years old age group (OR 0.41, 95% CI 0.32-0.52; P<.001). Around 80% (4347/5442) of the participants expressed interest in VC use. The most common occasions for which treatment by VC was reported to be suitable were discussing test results (1422/1896, 75.0%), taking the patient’s medical history (1195/2147, 55.7%), issuing prescriptions for drugs and remedies (793/1204, 65.9%), and the issuing of incapacity certificates for work (677/1042, 65.0%).

CONCLUSIONS: There has been an increase in the self-reported uptake of VC among physicians and psychotherapists compared to prepandemic levels, although this remains at a relatively low level in primary and specialist care. A significant proportion of doctors and psychotherapists have expressed an interest in using VC after the pandemic period. However, this self-reported use is not yet reflected in actual usage data, suggesting the need for further investigation into the underlying factors influencing the gap and identifying potential enablers. Further, these self-assessments by service providers on suitable types of treatment and suitable medical fields can inform political decision-making.

PMID:41494170 | DOI:10.2196/73757