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Nevin Manimala Statistics

Talazoparib plus enzalutamide versus olaparib plus abiraterone acetate and niraparib plus abiraterone acetate for metastatic castration-resistant prostate cancer: a matching-adjusted indirect comparison

Prostate Cancer Prostatic Dis. 2024 Dec 7. doi: 10.1038/s41391-024-00924-x. Online ahead of print.

ABSTRACT

BACKGROUND: Without head-to-head trials between talazoparib+enzalutamide (TALA + ENZA), olaparib+abiraterone acetate (OLAP + AAP), and niraparib plus AAP (NIRA + AAP) the ability to evaluate their relative efficacy as first-line (1 L) treatment in metastatic castration-resistant prostate cancer (mCRPC) is limited. The objective of this study was to assess the relative efficacy between TALA + ENZA (TALAPRO-2) versus OLAP + AAP (PROpel) and NIRA + AAP (MAGNITUDE) in 1 L mCRPC via a matching-adjusted indirect treatment comparison (MAIC).

METHODS: Patient-level data from TALAPRO-2 and published data from PROpel and MAGNITUDE were used. TALAPRO-2 data were reweighted to satisfy the eligibility criteria for PROpel and MAGNITUDE. Talazoparib (0.5 mg/day) plus enzalutamide (160 mg/day) was compared to olaparib (300 mg twice daily) plus abiraterone acetate (1000 mg/day) and niraparib (200 mg/day) plus abiraterone acetate (1000 mg/day). Hazard ratios (HRs) were calculated for radiographic progression-free survival (rPFS) and overall survival (OS), and odds ratios (ORs) for prostate-specific antigen (PSA) response and objective response rate (ORR). Additional efficacy outcomes were assessed.

RESULTS: In all-comers, TALA + ENZA was statistically superior to OLAP + AAP for rPFS (HR: 0.727; 95% confidence interval [CI]: 0.565, 0.935) and PSA response (OR: 1.663; 1.101, 2.510), and numerically favored for OS (HR: 0.847; 0.667, 1.076) and ORR (OR: 1.109; 0.646, 1.903). In patients with homologous recombination repair mutations (HRRm), relative to NIRA + AAP, TALA + ENZA was statistically superior for rPFS (HR: 0.460; 0.280, 0.754), and numerically favored for OS (HR: 0.601; 0.347, 1.041) and ORR (OR: 1.524; 0.579, 4.016).

CONCLUSIONS: Results suggest that TALA + ENZA may provide improvements in clinical outcomes relative to OLAP + AAP and NIRA + AAP in 1 L mCRPC; however, inherent limitations associated with the complexity of the analyses must be considered.

PMID:39645562 | DOI:10.1038/s41391-024-00924-x

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Nevin Manimala Statistics

Morphological and Mechanical Property Differences in Trapeziometacarpal Ligaments of Healthy and Osteoarthritic Female Joints

Ann Biomed Eng. 2024 Dec 7. doi: 10.1007/s10439-024-03660-4. Online ahead of print.

ABSTRACT

PURPOSE: To identify changes in morphological and mechanical properties in the volar ligament complex (VLC), dorsoradial ligaments (DRL), and posterior oblique ligaments (POL) in healthy and osteoarthritic female trapeziometacarpal (TMC) joints.

METHODS: Twenty-four fresh-frozen female cadaveric TMCs were separated into (1) younger healthy/early-stage osteoarthritic, (2) elder healthy/early-stage osteoarthritic, and (3) advanced-stage osteoarthritic groups based on age and Eaton-Littler grading. Stress relaxation and load-to-failure testing were performed to characterize mechanical tensile properties. Light imaging and scanning electron microscopy (SEM)/energy dispersive spectroscopy (EDS) were performed to further assess enthesis structural integrity.

RESULTS: The VLC in advanced-stage osteoarthritic TMCs had attenuated mechanical properties in stress relaxation experiments compared to the elder healthy/early-stage osteoarthritic specimens: Young’s modulus at 20% strain (P = 0.044), instantaneous (P = 0.023), relaxed (P = 0.017) moduli. VLCs in advanced-stage osteoarthritic TMCs also had significantly lower properties in the load-to-failure experiments compared to the younger healthy/early-stage osteoarthritic specimens: stiffness (P = 0.048), ultimate load (P = 0.017), toughness (P = 0.003). Light and SEM/EDS imaging revealed partial detachment and loss of enthesis mineral gradient at VLC metacarpal insertion in advanced-stage osteoarthritic specimens. There were no mechanical or structural changes in the DRL and POL between experiment groups.

CONCLUSION: VLC morphological and mechanical properties deteriorate across progressively severe osteoarthritis classifications while the DRL and POL remain unchanged. The attenuated mechanical properties of VLCs in advanced-stage osteoarthritic TMCs can be explained by ligament degradation as evidenced by partial detachment and loss of mineral gradient at the metacarpal insertion.

PMID:39645536 | DOI:10.1007/s10439-024-03660-4

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Nevin Manimala Statistics

Enhanced Recovery With Aggressive Ambulation Decreases Length of Stay in Lung Cancer Surgery

Clin Lung Cancer. 2024 Nov 16:S1525-7304(24)00251-1. doi: 10.1016/j.cllc.2024.11.010. Online ahead of print.

ABSTRACT

OBJECTIVE: Thoracic Enhanced Recovery with Ambulation after Surgery (T-ERAS) protocol at our institution includes ambulation into the operating room and 250-feet ambulation within 1 hour of extubation. We compared the average length of stay (LOS) between T-ERAS patients and that predicted using a validated surgical risk calculator.

METHODS: We retrospectively reviewed patients undergoing lung cancer resection with minimally invasive approach from 2012 to 2022. Patients aged ≥ 18 were included if early ambulation was documented. Patient information were entered into the American College of Surgeon’s National Surgical Quality Improvement Program Risk Calculator (NSQIP) to obtain the predicted LOS. Descriptive statistics, comparisons of observed versus predicted LOS (O/P ratio), and nonparametric testing were conducted.

RESULTS: Of 940 patients reviewed, 886 met eligibility. For the study cohort, average age was 68, and 514 (58.0%) were female. By procedure, there were 631(71.2%) lobectomy, 204 (23.0%) wedge, 26 (2.9%) segmentectomy, 20 (2.3%) bilobectomy, and 5 (0.6%) pneumonectomy. The average LOS observed for the entire cohort was 1.2 days (median 1.0 day) compared to the predicted LOS of 3.4 days with the NSQIP (median 4.0). Overall, 842 (95%) of patients had LOS better than predicted (O/P ratio < 1), 19 (2.1%) had LOS as predicted (O/P ratio = 1), and 25 (2.8%) had LOS longer than predicted (O/P ratio > 1). The mean O/P ratio was 0.34.

CONCLUSION: Average LOS with T-ERAS protocol was 1.2 days compared to the predicted average of 3.6 days in patients undergoing minimally invasive lung cancer resections. Our study provides a potential protocol to shorten the LOS beyond what is predicted by NSQIP.

PMID:39645529 | DOI:10.1016/j.cllc.2024.11.010

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Nevin Manimala Statistics

Occurrence of Auditory Impairments in Individuals With Dysphonia: A Scoping Review

J Voice. 2024 Dec 6:S0892-1997(24)00404-1. doi: 10.1016/j.jvoice.2024.11.021. Online ahead of print.

ABSTRACT

AIM: To investigate the occurrence of auditory impairments in individuals with dysphonia and to describe the results of behavioral and electrophysiological audiological assessments in this population.

STUDY DESIGN: A scoping review.

METHOD: A scoping review following the guidelines of the Joanna Briggs Institute Manual for Evidence Synthesis for Scoping Reviews and PRISMA-ScR. A search was carried out using the electronic databases PubMed, Scielo, and Lilacs, as well as the gray literature via Google Scholar. Using the Rayyan platform, the selection and extraction of data from the studies was carried out independently and blindly by two reviewers, with excellent agreement. The studies included in the review were subjected to extraction of the following information for analysis: authors, year of publication, objective, sample characteristics, dysphonia classification, audiological assessment procedure, and conclusion.

RESULTS: About 100 studies were found, and 13 eligible studies were included in the analysis. Of the studies included, 92.3% (n = 12) adopted cross-sectional designs, 76.9% (n = 10) investigated auditory functions in individuals with behavioral dysphonia, and 23.1% (n = 3) with organic dysphonia. The samples consisted of children in 53.8% (n = 7) of the studies and adults in 46.2% (n = 6), both with dysphonia. Around 53.80% (n = 7) of the studies included control groups without dysphonia. As for audiological assessment methods, 53.8% (n = 7) used behavioral tests of central auditory processing, 15.4% (n = 2) electrophysiological assessment, and 30.8% (n = 4) a combination of both.

CONCLUSION-: Individuals with dysphonia, especially of the behavioral type, may have deficits in auditory function. The main impairments refer to central auditory processing, especially in skills involving temporal processing, figure-ground skills, and auditory closure. Electrophysiological assessment does not show any significant differences between individuals with and without behavioral dysphonia. However, the frequency of follow-up response has a potential for greater impairment in this population. In cases of organic dysphonia, small and inconsistent impairments have been found, such as prolonged latencies of auditory potentials.

PMID:39645483 | DOI:10.1016/j.jvoice.2024.11.021

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Nevin Manimala Statistics

Voice Related Quality of Life Questionnaire (V-RQOL): Cross-Cultural Adaptation, Validity, and Reliability of the Azerbaijani-Turkish Version

J Voice. 2024 Dec 6:S0892-1997(24)00413-2. doi: 10.1016/j.jvoice.2024.11.029. Online ahead of print.

ABSTRACT

OBJECTIVES: There is no Azerbaijani-Turkish scale for assessing voice-related quality of life (V-RQOL). This study aimed to adapt the V-RQOL questionnaire to Azerbaijani-Turkish and evaluate its validity and reliability through cross-cultural adaptation.

STUDY DESIGN: A cross-sectional and prospective validation design was adopted.

METHODS: The V-RQOL was translated and culturally adapted into the Azerbaijani-Turkish language according to the methodology of standard forward-backward translations to obtain semantic, idiomatic, and conceptual equivalence. The study included 160 participants, with 80 having voice disorders and 80 not having voice disorders. Content validity with four experts through cognitive interviewing and face validity and the pilot study with 10 voice patients was performed. The construct validity was calculated by comparing the total score of the Azerbaijani-Turkish version of V-RQOL (AT-VRQOL) with the self-assessment results. The internal consistency of V-RQOL was examined using Cronbach’s alpha coefficient. To calculate the test-retest reliability coefficient, the AT-VRQOL was completed twice by 30 participants, including 20 with voice disorders and 10 without voice disorders, at intervals of 2 weeks.

RESULTS: Differences in the V-RQOL scores between participants with and without voice disorders were statistically significant (P < 0.001). The construct validity results showed that the total score of V-RQOL with the self-assessment results is correlated (r = 0.88, P < 0.001). The area under the curve value from the receiver operating characteristic curve was 100. The optimal cut-off point was 21.25, with a sensitivity of 80% and a specificity of 100%. The AT-VRQOL had high internal consistency, indicating excellent reliability (Cronbach’s alpha coefficient = 0.98). The total V-RQOL scores obtained from the two administrations of the test-retest reliability were examined. It was found that there was a high degree of correlation between the scores obtained in the two administrations (r = 0.99, P < 0.001).

CONCLUSIONS: The AT-VRQOL is a valid and reliable scale that can assess patients with voice disorders in a simple, easy, rapid way to apply and not time-consuming.

PMID:39645482 | DOI:10.1016/j.jvoice.2024.11.029

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Nevin Manimala Statistics

Cement layer thickness and load-bearing capacity of tooth restored with lithium-disilicate glass ceramic and hybrid ceramic occlusal veneers

Dent Mater. 2024 Dec 6:S0109-5641(24)00340-3. doi: 10.1016/j.dental.2024.11.004. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the influence of cement layer and veneer thickness on load-bearing capacity of tooth restored with hybrid ceramic (HC) and lithium-disilicate glass ceramic (LDGC) occlusal veneer restorations.

METHODS: Cement layer thickness was set at either 50 µm or 200 µm and tooth restored either with 0.5 mm or 1.8 mm thick HC Cerasmart270 (GC) or LDGC IPS e.max CAD (Ivoclar Vivadent) occlusal veneers. For this study, 64 extracted human molar teeth were selected and divided into 8 groups. Prepared teeth were scanned, and occlusal veneers were manufactured using CAD/CAM technology (Cerec, Dentsply-Sirona). Finished veneers were luted to preparations using self-adhesive resin cement (G-CEM ONE) according to manufacturers’ instructions. Teeth were loaded quasi-statically and ultimate fracture loads were recorded. Fracture types were analyzed and classified visually. Statistical analysis was performed using two-way ANOVA.

RESULTS: With HC occlusal veneers, thickness of both veneer and cement layer had no significant influence on fracture load. The lowest mean ultimate fracture load value was found in 0.5 mm thick LDGC veneers group with 200 µm cement layer, which was significantly lower loading value compared with that of 1.8 mm thick LDGC veneers or any of HC veneers (p ≤ 0.0280). LDGC veneers with 0.5 mm thickness showed fractures within the veneer, whereas in other groups fractures of the tooth substance was also detected.

CONCLUSIONS: Within the limitations of this study, it can be concluded that thin HC occlusal veneers provided higher load-bearing capacity than LDGC counterparts of the same thickness. HC veneers were also less sensitive to the effect of cement layer thickness.

PMID:39645474 | DOI:10.1016/j.dental.2024.11.004

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Nevin Manimala Statistics

Automated Classification of Body MRI Sequences Using Convolutional Neural Networks

Acad Radiol. 2024 Dec 6:S1076-6332(24)00891-2. doi: 10.1016/j.acra.2024.11.046. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVES: Multi-parametric MRI (mpMRI) studies of the body are routinely acquired in clinical practice. However, a standardized naming convention for MRI protocols and series does not exist currently. Conflicts in the series descriptions present in the DICOM headers arise due to myriad MRI scanners from various manufacturers used for imaging, wide variations in imaging practices across institutions, and technologist preferences. These conflicts affect the hanging protocol, which dictates the arrangement of sequences for the reading radiologist. At present, clinician supervision is necessary to ensure that the correct sequence is being read and used for diagnosis. This pilot work seeks to classify five different series in mpMRI studies acquired at the levels of the chest, abdomen, and pelvis.

MATERIALS AND METHODS: First, 2D and 3D classification networks were compared using data acquired by Siemens scanners and the optimal network was identified. Then, its performance was analyzed when trained with different training data quantities. The out-of-distribution (OOD) robustness on data acquired by a Philips scanner was also measured. In addition, the effect of data augmentation on model training was studied. The model was also tested with smaller input volumes through downsampling or cropping. Finally, the model was trained on combined data from both Siemens and Philips scanners to bridge the performance gap between different scanners.

RESULTS: Among 2D and 3D networks of ResNet-50, ResNet-101, DenseNet- 121, and EfficientNet-BN0, the 3D DenseNet-121 ensemble achieved an F1 score of 99.5% when tested on data from the Siemens scanners. The model performed well on OOD data from the Philips scanner and achieved an F1 score of 86.5%. There was no statistically significant difference between the models trained with and without data augmentation, and between the models trained with original-sized input and with smaller-sized input. When training the model with combined data, the F1 score improved to 98.8% for the Philips test set and 99.3% for the Siemens test set respectively.

CONCLUSION: Our pilot work is useful for the classification of MRI sequences in studies acquired at the level of the chest, abdomen, and pelvis. It has the potential for robust automation of hanging protocols and the creation of large-scale data cohorts for pre-clinical research.

PMID:39645459 | DOI:10.1016/j.acra.2024.11.046

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Simulation-based education at level 4: The role of multidisciplinary team input in the design and facilitation of a simulated radiographic placement

Radiography (Lond). 2024 Dec 6:S1078-8174(24)00348-1. doi: 10.1016/j.radi.2024.11.017. Online ahead of print.

ABSTRACT

INTRODUCTION: Simulation based education (SBE) and creatively designed placements are becoming increasingly well established in radiography pedagogy and allow a more efficient use of clinical resources in the training of new radiographers to meet workforce demands. Student radiographers have expressed concern about striking a balance between providing patient centered care and developing their radiographic competency. A co-designed simulated placement was developed with a focus on these two aspects of radiography education aiming to increase the competence and confidence of level 4 students while incorporating patient centred care (PCC) into their practice.

METHODS: A multidisciplinary approach was used to develop a nine-day simulation where activities were scaffolded to help student radiographers to learn, develop and revisit critical skills. The students completed a reflective journal during this placement, the contents of which were thematically analysed.

RESULTS: Students reported a statistically significant improvement in perceived confidence levels related to both radiographic and broad-based skills after simulation sessions. Several additional themes emerged from the reflective data related to communication skills, preparation for practice, perceptions of simulation and an empowered identity as a student radiographer. The students’ reflective diaries also explored students’ perceptions of their roles in the promotion patient centred care and they reported that the addition of realistic stressors inspired by the clinical environment, allowed them to practice dealing with these situations in a safe space.

CONCLUSION: SBE effects students’ perceptions of their competence and confidence in the clinical environment. By providing a safe space, SBE empowers students to respond to some stressors that might be encountered in clinical practice. A carefully scaffolded, multidisciplinary approach to simulated placement is good for confidence and competence building.

IMPLICATIONS FOR PRACTICE: The multi-professional dynamic partnership enabled effective collaboration to deliver a positively evaluated simulation package. Students were motivated to deliver enhanced PCC and had a strong desire to drive change, to guarantee patient safety and high-quality care.

PMID:39645446 | DOI:10.1016/j.radi.2024.11.017

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Nevin Manimala Statistics

Test-retest reliability of strength, power, agility, and sprint performance in female team handball players

J Sci Med Sport. 2024 Nov 26:S1440-2440(24)00581-4. doi: 10.1016/j.jsams.2024.11.008. Online ahead of print.

ABSTRACT

OBJECTIVES: This study assessed the test-retest reliability of athletic performance tests in a cohort of trained Norwegian female handball players, as well as a sub-analysis of the test-retest reliability for naturally menstruating players.

DESIGN: Eighteen handball players (naturally menstruating: n = 8) completed performance test batteries on three separate occasions.

METHODS: The performance test battery included: a 1-repetition Smith machine back squat, maximal handgrip strength tests, counter-movement jumps, squat jumps, a modified agility T-test, and 15-m linear sprints. For the naturally menstruating players, the testing sessions were completed at three hormonally-distinct points within a menstrual cycle (i.e., early follicular, ovulation, and mid-luteal phases). Reliability statistics (intraclass correlations, standard error of measurement, minimum difference, and coefficient of variation) were calculated for each performance test.

RESULTS: Good-to-excellent test-retest reliability was found for all performance measures (intraclass correlation2,1 point estimates = 0.82 to 0.94), although max squat jumps were somewhat lower (intraclass correlation2,1 = 0.75 [95 % confidence interval = 0.55, 0.88]). Subgroup analysis for naturally menstruating players also revealed consistently high reliability values for all tests (intraclass correlation2,1 point estimate = 0.83 to 0.74).

CONCLUSIONS: These reliability data support the periodic use of selected athletic tests in routine handball assessments, in order to identify changes in sporting performance and monitor player progress. As test reliability does not appear to be influenced by the menstrual cycle phase, coaches and sports practitioners may schedule testing sessions for all athletes, without concern of a confounding effect from menstrual phases.

PMID:39645439 | DOI:10.1016/j.jsams.2024.11.008

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Nevin Manimala Statistics

Fracture resistance, 3-dimensional finite element analysis, and safety factors for five post-and-core restorations with crowns placed in the noncircular-shaped canals of premolars

J Prosthet Dent. 2024 Dec 6:S0022-3913(24)00743-1. doi: 10.1016/j.prosdent.2024.11.001. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: Restoring endodontically treated premolars with noncircular canals presents a significant challenge.

PURPOSE: The purpose of this study was to compare the in vitro fracture resistance and the finite element computational calculation-based stress and safety factor of noncircular-shaped, endodontically treated premolars restored with 5 different prefabricated and custom computer-aided design and computer-aided manufactured post-and-core systems.

MATERIAL AND METHODS: Fifty single-rooted oval-shaped canal maxillary premolars were endodontically treated and post spaces were prepared. The specimens were divided into 5 categories on the basis of the post-and-core system used: Group CN composite resin core without a post, Group CF prefabricated fiber-reinforced composite resin post and composite resin core, Group IC interpenetrating phase composite post-and-core, Group LS lithium disilicate post-and-core, and Group ZR zirconia post-and-core. Lithium disilicate crowns were fabricated and cemented on the 5 different post-and-core systems and subjected to a fracture resistance test using a spherical indenter with static loading. Differences in fracture resistance were evaluated using a 1-way analysis of variance (ANOVA) (α=.05). The 3-dimensional finite element method was used to determine the von Mises stress and safety factors, defined as the ratio of the material’s strength to the von Mises stress experienced, within different compartments of the restored tooth model.

RESULTS: In the in vitro fracture resistance test, the mean ±standard deviation fracture loads of the 5 groups were 2144 ±515 N, 1801 ±600 N, 1690 ±312 N, 1612 ±545 N, and 1487 ±600 N, respectively and were statistically similar (P=.078). All specimens within the ZR group exhibited restorable fractures. In contrast, only 30% of the CN group specimens showed restorable fractures. The incidence of restorable fractures in the CF, IC, and LS groups was 70%, 80%, and 70%, respectively. Although all groups showed similar maximum von Mises stress and stress distribution, safety factors in the models varied significantly. The ceramic crown was the weakest component in the LS and ZR groups, with much lower safety factors than dentin and post-and-core regions. Additionally, the CN group’s wider dentin area had a demonstrably lower safety factor.

CONCLUSIONS: Endodontically treated noncircular-shaped canal premolars showed minimal effect on fracture resistance regardless of post type. However, for teeth with sufficient ferrule, using any post-and-core system significantly reduced the incidence of nonrestorable fractures compared with just a coronal foundation restoration, with custom zirconia offering the potential of achieving a restorable outcome after fracture.

PMID:39645437 | DOI:10.1016/j.prosdent.2024.11.001