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Nevin Manimala Statistics

Changes in LDL-cholesterol levels following aromatase inhibitor treatment in early postmenopausal breast cancer

Eur J Epidemiol. 2025 May 21. doi: 10.1007/s10654-025-01228-7. Online ahead of print.

ABSTRACT

There is an unsettled concern that treatment with aromatase inhibitors (AIT) may adversely affect lipid-levels. In light of the improved survival of women with breast cancer and increased risk of atherosclerotic cardiovascular disease in older people, unfavorable effects on lipid-levels may represent a significant health concern for this group of patients. We used linked data from nationwide registries, including a clinical breast cancer database with information about allocated and dispensed AIT. Based on these, we investigated changes in plasma lipid-levels (primary outcome: low-density lipoprotein (LDL)-cholesterol, secondary outcomes: high-density lipoprotein (HDL)-cholesterol, total cholesterol, and triglycerides) following AIT in a nationwide cohort of postmenopausal women with early breast cancer, Denmark, 2009-2020. Included women had at least one LDL-cholesterol measurement before and after breast cancer diagnosis. Exposure was allocated and dispensed AIT as compared with not allocated to and no dispensed AIT. Outcome was the adjusted difference in lipid-level-change (from before to after breast cancer diagnosis) according to AIT. Among 10,461 women, there were 22,693 pre-breast cancer LDL-cholesterol measurements and 42,750 post-breast cancer LDL-cholesterol measurements. Overall, 7919 of the women were exposed to AIT and 2542 women were unexposed. For AIT exposed, the LDL-cholesterol-change was – 0.16 mmol/L (mM), and for unexposed, – 0.15 mM, respectively. The corresponding adjusted difference in LDL-cholesterol change for AIT exposed versus unexposed was – 0.03 mM (95% CI – 0.07 to 0.003). We found similar results in analysis of secondary outcomes. This study does not support the concern that AIT adversely affects lipid-levels.

PMID:40397354 | DOI:10.1007/s10654-025-01228-7

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On-field Head Acceleration Exposure Measurement Using Instrumented Mouthguards: Missing Data Imputation for Complete Exposure Analysis

Ann Biomed Eng. 2025 May 21. doi: 10.1007/s10439-025-03747-6. Online ahead of print.

ABSTRACT

PURPOSE: Accurate quantification of head acceleration event (HAE) exposure is critical for investigating brain injury risk in contact sports athletes. However, missing HAEs may be unavoidable in real-world data collection. This study introduces missing data imputation methods to estimate complete video- and sensor-based HAE exposure.

METHODS: We captured and verified university men’s ice hockey HAEs using video and instrumented mouthguards (iMGs) in one varsity season (nathletes = 27, ngames = 31). A statistical mapping technique was first introduced to impute missing video-based HAEs during away games with limited camera angles. We then applied multiple imputation to impute missing iMG-based HAEs using captured data, including the complete video-based HAE exposure. This enabled estimation of complete exposure data at a per-athlete level over all games of the season.

RESULTS: Among 591 athlete-games, 45% did not have any recorded iMG data. We find that data imputation increased the median values of per-athlete-season video- and iMG-based HAE counts by 10% and 69%, respectively. Consequently, common head kinematics- and brain deformation-based cumulative exposure metrics also increased substantially (median per-athlete-season cumulative peak linear acceleration by 95%, peak angular acceleration by 109%, and corpus callosum strain by 69%).

CONCLUSION: This study highlights the potential underestimation of exposure metrics due to missing HAEs and fills a critical gap in sports HAE exposure research. Future studies should incorporate missing data imputation methods for more accurate estimation of HAE exposure in investigating acute and long-term brain trauma risks.

PMID:40397312 | DOI:10.1007/s10439-025-03747-6

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Olaparib Monotherapy or in Combination with Abiraterone for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and a BRCA Mutation

Target Oncol. 2025 May 21. doi: 10.1007/s11523-025-01146-4. Online ahead of print.

ABSTRACT

Treatment strategies to improve outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) are evolving. Of particular interest are therapies that target DNA damage responses in tumor cells by inhibiting poly(ADP-ribose) polymerase (PARP) activity. Several PARP inhibitors have recently received regulatory approval for the treatment of patients with mCRPC, of which olaparib was the first for prostate cancer. Olaparib received approval as a monotherapy following the PROfound study (NCT02987543) and in combination with abiraterone following the PROpel study (NCT03732820) for mCRPC. Both PROfound (homologous recombination repair mutation biomarker-selected) and PROpel (biomarker unselected) patients demonstrated statistically significant longer radiographic progression-free survival (rPFS) with olaparib versus their respective control arms in the intention-to-treat population. In both studies, the greatest clinical benefit with olaparib was seen in patients with BRCA1 and/or BRCA2 mutations (BRCAm): PROfound rPFS hazard ratio (HR) 0.22 (95% confidence interval [CI] 0.15-0.32); PROpel rPFS HR 0.23 (95% CI 0.12-0.43). Clinical benefit was also observed in terms of overall survival: PROfound HR 0.63 (95% CI 0.42-0.95); PROpel HR 0.29 (95% CI 0.14-0.56). We provide a comprehensive overview of the utility of olaparib for patients with mCRPC harboring a BRCAm. Key clinical and safety data in BRCAm subgroup populations are discussed, predominantly based on findings from PROfound and PROpel, as well as investigator-initiated studies, to help inform treatment decision-making in this patient population. We also discuss the importance of genetic testing to identify patients who may optimally benefit from treatment with olaparib, either as a monotherapy or in combination with abiraterone.

PMID:40397306 | DOI:10.1007/s11523-025-01146-4

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Simulation education in the age of competency-based medical education: a study of the use of simulation-based education in Canadian emergency medicine programs

CJEM. 2025 May 21. doi: 10.1007/s43678-025-00935-0. Online ahead of print.

ABSTRACT

OBJECTIVE: In 2018, Royal College emergency medicine residency programs shifted to a competency-based medical education framework. This study sought to explore the impact of this transition on simulation-based education activities, including the use of simulation for assessment, in emergency medicine programs across Canada.

METHODS: An interview guide was created by the authors evaluating the current role of simulation in emergency medicine programs based on the Core Components framework of competency-based medical education. Semi-structured interviews of emergency medicine simulation directors across Canada were conducted virtually between May 2022 and December 2022. Descriptive statistics of quantitative data are reported and qualitative responses were analyzed using thematic analysis.

RESULTS: Interviews represented 11/14 (78.5%) emergency medicine programs in Canada. Competency-based medical education national standards were commonly used to identify gaps in training experiences, particularly with high acuity low opportunity scenarios that could be addressed using simulation. Furthermore, competency-based medical education provided a framework where simulation curricula were revised and allowed for mapping of simulation scenarios to specific required training experiences and assessment requirements. All programs reported a new role of assessment in simulation largely in the form of entrustable professional activity assessments to satisfy the requirement of competency-based medical education. However, concerns were raised around the increasing role of assessment and its impact on psychological safety of the simulation learning environment.

CONCLUSION: The introduction of competency-based medical education has elevated the role of simulation as a means of assessing learner competencies. This shift has been largely positive, by facilitating resident assessment of required training experiences, but with some possible negative consequences related to the impact of assessments on the psychological safety traditionally afforded by the simulation environment. As such, educators must be intentional in how simulation is used in their program with particular attention given to the validity of assessments and the impact on safety of the learning environment.

PMID:40397303 | DOI:10.1007/s43678-025-00935-0

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The Spontaneous Abortion of Females is Influenced by Their Male Partner’s Heat Wave Exposure During Adolescence: A Nationwide Observational Study in China

Curr Med Sci. 2025 May 21. doi: 10.1007/s11596-025-00063-x. Online ahead of print.

ABSTRACT

OBJECTIVE: Heat wave exposure significantly impacts human health. Nevertheless, studies on the long-term effects of heat wave exposure during adolescence on adverse pregnancy outcomes (APOs) are rare. This study aimed to investigate the relationship between the long-term effects of heat wave exposure during adolescence and APOs.

METHODS: We analyzed data from 3,376 female and 3,013 male participants across 31 provinces in China. All adolescents (10-19 years old), early adolescents (10-14), and late adolescents (15-19) were chosen as exposure windows. Heat waves were defined as periods lasting 2‒4 consecutive days with the daily temperature exceeding the 75th, 90th, and 92.5th percentiles. We employed multivariate logistic regression models to assess the associations between exposure to heat waves during adolescence and APOs.

RESULTS: The results revealed significant associations between male exposure to heat wave events during late adolescence and spontaneous abortion (P < 0.05), which was more pronounced in South China. In contrast, no statistically significant associations were detected between males’ exposure to heat wave events during adolescence and their partners’ preterm birth (P > 0.05 for all comparisons). The exposure of females to heat waves during adolescence was not significantly associated with subsequent spontaneous abortion or preterm birth (P > 0.05 for all comparisons).

CONCLUSIONS: This study demonstrates that spontaneous abortion in females is associated with heat wave exposure in their male partner during adolescence.

PMID:40397301 | DOI:10.1007/s11596-025-00063-x

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Triggers for identifying anticoagulation-associated adverse drug events in hospitalized patients: a systematic review and meta-analysis

Int J Clin Pharm. 2025 May 21. doi: 10.1007/s11096-025-01916-0. Online ahead of print.

ABSTRACT

BACKGROUND: Anticoagulation therapy presents a high risk of adverse drug events (ADEs) in hospitalized patients, highlighting the need for effective detection strategies in clinical practice.

AIM: The review aimed to identify triggers for detecting anticoagulation-associated ADEs in hospitalized patients and describe the performance of these triggers.

METHOD: PubMed, Cochrane, and Embase were queried until April 19, 2024. We included studies on trigger tools for detecting anticoagulation-related ADEs in hospitalized patients. The study quality was assessed using the Quality Assessment Trigger framework based on the QUADAS-2 tool for diagnostic accuracy. We performed random-effects meta-analyses to pool positive predictive values (PPV), with heterogeneity assessed via I2 statistic and Cochran’s Q test.

RESULTS: Twenty-three studies were included. Seventeen triggers were reported and categorized into three modules: abnormal laboratory values (11 triggers), medications or antidotes (three triggers), and care (three triggers). Elevated international normalized ratio (INR) was the most prevalent trigger (16 studies) with a PPV of 0.539 (95% Confidence Interval [CI] 0.310-0.768). Other triggers exhibited lower pooled PPVs than elevated INR, including vitamin K administration (15 studies, PPV 0.222, 95% CI 0.153-0.290), abrupt medication cessation (14 studies, PPV 0.418, 95% CI 0.169-0.667), and activated partial thromboplastin time > 100 s (11 studies, PPV 0.336, 95% CI 0.173-0.498). Importantly, in-hospital stroke (three studies) had the highest pooled PPV of 0.964 (95% CI 0.803-1.000).

CONCLUSION: This review demonstrated the variability in PPVs of triggers for anticoagulation-associated ADEs, emphasizing the necessity for a specialized trigger tool for hospitalized patients on anticoagulants.

PMID:40397288 | DOI:10.1007/s11096-025-01916-0

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Comparative analysis of shear bond strength and debonding characteristics of bioactive versus conventional orthodontic adhesives: An in-vitro study

Saudi Dent J. 2025 Apr 15;37(1-3):3. doi: 10.1007/s44445-025-00002-5.

ABSTRACT

Adhesives are essential for attaching orthodontic brackets to the tooth surface and ensuring safe removal during debonding. ACTIVA™ BioACTIVE-Restorative (ABR) is a bioactive composite with potential advantages. The purpose of this study was to evaluate the shear bond strength (SBS) and adhesive remnant index (ARI) of ACTIVA™ BioACTIVE-Restorative (ABR) with conventional adhesives, including Transbond XT™ (TXT) and Orthocem™ (OC). A total of 51 human maxillary premolars were distributed randomly into three groups (n = 17). Each group was bonded with one adhesive following the manufacturer’s protocols. Then were subjected to 5000 thermocycles to simulate oral conditions. SBS was measured using a universal testing machine, and ARI scores were visually analysed under magnification. Statistical analysis was conducted using one-way ANOVA and chi-squared tests, with a 0.05 level of significance. Mean SBS values were 11.26 MPa, 12.52 MPa, and 12.96 MPa for ABR, TXT, and OC, respectively, with no significant differences (p = 0.513). ARI analysis revealed significant differences (p = 0.009) as ABR predominantly exhibited ARI 3 scores, indicating no adhesive remnants on enamel. In contrast, TXT and OC groups showed higher adhesive retention. ABR demonstrated shear bond strength comparable to conventional adhesives, meeting the clinical thresholds for orthodontic use. But demonstrated more complete adhesive failure in the enamel-adhesive interface rather than cohesive failure within the adhesive material like in TXT and OC.

PMID:40397265 | DOI:10.1007/s44445-025-00002-5

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Beyond Motor Impairment: Empowering Functional Performance With Robotics

OTJR (Thorofare N J). 2025 May 21:15394492251324915. doi: 10.1177/15394492251324915. Online ahead of print.

ABSTRACT

There is an increasing need for assistive robots to support independent living for people with physical disabilities, but few are commercially accessible to users in their homes. Our objective was to investigate how the functional performance of everyday activities improved the performance of an individual with quadriplegia using the Stretch robot. We implemented a participatory design approach using a single subject volunteer sampling. Point-in-time evaluations included Stroke Specific Quality of Life Scale (SS-QOL) and Stroke Impact Scale (SIS). Pre- and post-measures included the Goal Attainment Scale (GAS) to assess intervention effectiveness on personalized goals. There was a statistically significant improvement in baseline GAS scores based on the individual’s goals in grooming (+2), self-feeding (+2), social participation (+2 giving a rose, +0 playing cards), and meal planning (+2) along with a T-scale score of 74.43. The individual’s functional performance in daily activities improved with Stretch while reducing care partner assistance, contributing positively to their experiences.

PMID:40396342 | DOI:10.1177/15394492251324915

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Mechanisms of Change in Cognitive-Behavioral Therapy for Adults With Binge-Eating Disorder: A Dynamic Structural Equation Modeling Approach

Int J Eat Disord. 2025 May 21. doi: 10.1002/eat.24469. Online ahead of print.

ABSTRACT

OBJECTIVE: Cognitive-behavioral therapy (CBT) is the most well-established treatment for binge-eating disorder (BED), but the mechanisms of change remain poorly understood. This study investigated in CBT for BED the effects of overvaluation of shape and weight and dietary restraint on subsequent objective binge-eating episodes (OBEs).

METHOD: In a multicenter randomized-controlled trial, 84 patients diagnosed with full- or subsyndromal BED were offered 20 individual sessions of CBT over 4 months. Dynamic structural equation modeling (DSEM) was used to disentangle within- and between-patient associations of overvaluation of shape and weight, dietary restraint, and OBEs.

RESULTS: Between the first and last week of therapy, there were significant reductions in overvaluation of shape and weight, dietary restraint, and OBEs. DSEM showed significant within-patient effects of overvaluation of shape and weight on the subsequent number of OBEs. Weeks with lower overvaluation of shape and weight levels were followed by weeks with fewer OBEs. Although no within-patient effect of dietary restraint on OBEs was found, within-patient dietary restraint levels positively predicted subsequent overvaluation of shape and weight levels.

DISCUSSION: The findings suggest that reductions in overvaluation of shape and weight may precede improvements in binge eating during CBT for BED, supporting its role as a potential mechanism of change. While dietary restraint did not show a direct temporal link to binge eating, its association with overvaluation points to a potential indirect role. These results underscore the value of targeting cognitive features of BED in CBT and highlight the need for more temporally sensitive assessments in mechanisms research.

PMID:40396334 | DOI:10.1002/eat.24469

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Objective Quality Assessment of the Capsulorhexis – A Novel Augmented Reality Tool for Trainees and Experts

Curr Eye Res. 2025 May 21:1-8. doi: 10.1080/02713683.2025.2504569. Online ahead of print.

ABSTRACT

PURPOSE: To assess the usability of a smartphone-based augmented reality tool for capsulorhexis training.

METHODS: This is a single-center, prospective, clinical study conducted at the Department of Ophthalmology, University Hospital, LMU Munich, Munich, Germany. Surgery-naïve residents were included and divided into three subgroups: (1) augmented reality supported by the Custom Surgical MicroREC system during their capsulorhexis procedures; (2) Expert support supported by an experienced cataract surgeon; (3) No support without support. Capsulorhexis quality was graded by circularity, centration, and radius.

RESULTS: Twenty-one (ntotal = 21) participants were enrolled. The augmented reality group was statistically significantly better in terms of circularity than the Expert support (Mann-Whitney’s U-test: p = .00175) and the No support group (Mann-Whitney’s U-test: p = .00268). The procedure duration decreased statistically significantly for all three groups when try 1 and 10 were compared (augmented reality: p < .0001; Expert support: p = .0099; No support: p < .0001). The other parameters did not differ statistically significantly. The questionnaires handed to the augmented reality and No support group before and after the wet lab revealed a high importance of wet lab trainings to all polled participants. The provided wet lab setup was considered adequate by both groups.

CONCLUSION: Augmented reality can assist in cataract training. The Custom Surgical MicroREC system can have a positive influence on capsulorhexis quality in a training environment. Automated quality metrics measured by the augmented reality software provide an objective quality score of the performed surgical procedure. As the tested augmented reality system can be used in training as well as in a real-world setting, this will be a useful tool for trainees and expert surgeons alike.

PMID:40396333 | DOI:10.1080/02713683.2025.2504569