Category: Statistics

J Magn Reson Imaging. 2023 Aug 1. doi: 10.1002/jmri.28900. Online ahead of print.

ABSTRACT

BACKGROUND: Tertiary lymphoid structures (TLSs) are potential prognostic indicators. Radiomics may help reduce unnecessary invasive operations.

PURPOSE: To analyze the association between TLSs and prognosis, and to establish a nomogram model to evaluate the expression of TLSs in breast cancer (BC) patients.

STUDY TYPE: Retrospective.

POPULATION: Two hundred forty-two patients with localized primary BC (confirmed by surgery) were divided into BC + TLS group (N = 122) and BC – TLS group (N = 120).

FIELD STRENGTH/SEQUENCE: 3.0T; Caipirinha-Dixon-TWIST-volume interpolated breath-hold sequence for dynamic contrast-enhanced (DCE) MRI and inversion-recovery turbo spin echo sequence for T2-weighted imaging (T2WI).

ASSESSMENT: Three models for differentiating BC + TLS and BC – TLS were developed: 1) a clinical model, 2) a radiomics signature model, and 3) a combined clinical and radiomics (nomogram) model. The overall survival (OS), distant metastasis-free survival (DMFS), and disease-free survival (DFS) were compared to evaluate the prognostic value of TLSs.

STATISTICAL TESTS: LASSO algorithm and ANOVA were used to select highly correlated features. Clinical relevant variables were identified by multivariable logistic regression. Model performance was evaluated by the area under the receiver operating characteristic (ROC) curve (AUC), and through decision curve analysis (DCA). The Kaplan-Meier method was used to calculate the survival rate.

RESULTS: The radiomics signature model (training: AUC 0.766; test: AUC 0.749) and the nomogram model (training: AUC 0.820; test: AUC 0.749) showed better validation performance than the clinical model. DCA showed that the nomogram model had a higher net benefit than the other models. The median follow-up time was 52 months. While there was no significant difference in 3-year OS (P = 0.22) between BC + TLS and BC – TLS patients, there were significant differences in 3-year DFS and 3-year DMFS between the two groups.

DATA CONCLUSION: The nomogram model performs well in distinguishing the presence or absence of TLS. BC + TLS patients had higher long-term disease control rates and better prognoses than those without TLS.

EVIDENCE LEVEL: 2 TECHNICAL EFFICACY: Stage 2.

PMID:37526043 | DOI:10.1002/jmri.28900

Vet Ophthalmol. 2023 Aug 1. doi: 10.1111/vop.13138. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess whether gonioscopy performed on Samoyed puppies (6-14 weeks of age) is a reliable predictor of their gonioscopy results as adults (>11 months of age).

PROCEDURE: A retrospective medical record search was performed to identify Samoyed dogs that had undergone gonioscopy as a puppy (6-14 weeks of age). A second prospective gonioscopy examination was performed as an adult (>11 months of age) and the results were compared. Gonioscopy was assessed on two characteristics: percent of iridocorneal angle (ICA) unaffected by pectinate ligament abnormalities (PLA) and ICA width, with PLA results categorized into unaffected ( $\ge$ 75% open), moderately affected (50%-74% open), and severely affected (<50% open) and the width categorized into wide, moderate, narrow, and closed groups. A multivariate model was created that considered factors such as PLA, angle width, sex, puppy age, neuter status, and time between examinations.

RESULTS: The eyes of 77 Samoyed dogs (154 eyes) met inclusion criteria. When assessing PLA, 90% of dogs had the same categorization as a puppy and as an adult. When assessing ICA width, 53.2% of dogs had the same width classification as a puppy and as an adult. There is strong evidence that variation between puppy and adult results increases with time between examination (p = .03).

CONCLUSION: Puppies unaffected by PLA and with a wide ICA angle, are likely to retain these features as adults. Selection of puppies with desirable gonioscopic traits may help breeders to choose dogs likely to retain these traits as adults for breeding. This may reduce the incidence of glaucoma in the breed. Puppy examinations should be performed in both eyes. Examination of adults prior to breeding remains prudent.

PMID:37526040 | DOI:10.1111/vop.13138

Circ Heart Fail. 2023 Aug 1:e010262. doi: 10.1161/CIRCHEARTFAILURE.122.010262. Online ahead of print.

ABSTRACT

BACKGROUND: Common genetic variants are associated with risk for hypertrophic cardiomyopathy and dilated cardiomyopathy and with left ventricular (LV) traits. Whether these variants are associated with myocardial fibrosis, an important pathophysiological mediator of cardiomyopathy, is unknown.

METHODS: Multi-Ethnic Study of Atherosclerosis participants with T1-mapping cardiac magnetic resonance imaging in-whom extracellular volume was assessed, and genotyping information was available were included (N=1255). Log extracellular volume (%) was regressed on 50 candidate single nucleotide polymorphisms (previously identified to be associated with hypertrophic cardiomyopathy, dilated cardiomyopathy, and LV traits) adjusting for age, sex, diabetes, blood pressure, and principal components of ancestry. Ancestry-specific results were pooled by fixed-effect meta-analyses. Gene knockdown experiments were performed in human cardiac fibroblasts.

RESULTS: The SMARCB1 rs2186370 intronic variant (minor allele frequency: 0.18 in White and 0.50 in Black participants), previously identified as a risk variant for dilated cardiomyopathy and hypertrophic cardiomyopathy, was significantly associated with increased extracellular volume (P=0.0002) after adjusting for confounding clinical variables. The SMARCB1 rs2070458 locus previously associated with increased LV wall thickness and mass was similarly significantly associated with increased extracellular volume (P=0.0002). The direction of effect was similar in all 4 ancestry groups, but the effect was strongest in Black participants. The variants are strong expression quantitative loci in human LV tissue and associated with genotype-dependent decreased expression of SMARCB1 (P=7.3×10^-22). SMARCB1 knockdown in human cardiac fibroblasts resulted in increased TGF (transforming growth factor)-β1-mediated α-smooth muscle actin and collagen expression.

CONCLUSIONS: Common genetic variation in SMARCB1 previously associated with risk for cardiomyopathies and increased LV wall thickness is associated with increased cardiac magnetic resonance imaging-based myocardial fibrosis and increased TGF-β1 mediated myocardial fibrosis in vitro. Whether these findings suggest a pathophysiologic link between myocardial fibrosis and cardiomyopathy risk remains to be proven.

PMID:37526028 | DOI:10.1161/CIRCHEARTFAILURE.122.010262

J Med Econ. 2023 Aug 1:1-32. doi: 10.1080/13696998.2023.2240957. Online ahead of print.

ABSTRACT

AIMS: In the SUSTAIN 6 cardiovascular outcomes trial, once-weekly semaglutide was associated with a statistically significant reduction in major adverse cardiovascular events compared with placebo. To date, no studies have assessed how accurately existing diabetes models predict the outcomes observed in SUSTAIN 6. The aims of this analysis were to investigate the performance of the IQVIA Core Diabetes Model when used to predict the SUSTAIN 6 trial outcomes, to calibrate the model such that projected outcomes reflected observed outcomes, and to examine the impact of calibration on the cost-effectiveness of once-weekly semaglutide from a UK healthcare payer perspective.

METHODS: The IQVIA Core Diabetes Model was calibrated to ensure that the projected non-fatal stroke event rates reflected the non-fatal stroke event rates observed in SUSTAIN 6 over a 2-year time horizon. Cost-effectiveness analyses of once-weekly semaglutide versus placebo plus standard of care were conducted over a lifetime horizon using the uncalibrated and calibrated models to assess the impact on cost-effectiveness outcomes.

RESULTS: To replicate the non-fatal stroke event rate in SUSTAIN 6, calibration of the model through the application of relative risks for stroke of 1.07 and 1.65 with once-weekly semaglutide and placebo, respectively, was required. In the long-term cost-effectiveness analysis, the uncalibrated model projected an incremental cost-effectiveness ratio for once-weekly semaglutide versus placebo plus standard of care of GBP 22,262 per quality-adjusted life year (QALY) gained, which fell to GBP 17,594 per QALY gained when the calibrated model was used.

CONCLUSIONS: The requirement for calibration to replicate the outcomes observed in SUSTAIN 6 suggests that the reductions in risk of cardiovascular complications observed with once-weekly semaglutide cannot be solely explained by differences in conventional risk factors. Accurate estimation of the risk of diabetes-related complications using methods such as calibration is important to ensure accurate cost-effectiveness analyses are conducted.

PMID:37525970 | DOI:10.1080/13696998.2023.2240957

Front Biosci (Landmark Ed). 2023 Jul 24;28(7):146. doi: 10.31083/j.fbl2807146.

ABSTRACT

BACKGROUND: High blood pressure is the main cause of cardiovascular diseases. Kidney damage is one of the most common organ secondary damage to hypertension. The study of hypertension gene polymorphisms is an important means of precision treatment of primary hypertension.

OBJECTIVES: The objective of this study was to explore the relationship between AGTR1 (c.1166 A>C) gene polymorphisms and hypertension combined with kidney damage, while exploring the relationship between codominant, dominant and recessive gene model and hypertension with kidney injury and the susceptibility of different genotypes to hypertension with kidney injury.

METHODS: The distribution of AGTR1 polymorphism in the AGTR1 in hypertensive patients (hypertension group, 292 patients) and hypertension with kidney injury patients (44 patients) were detected and compared by PCR-melting curve method.

RESULTS: The genotype distribution of hypertension and combined groups met Hardy-Weinberg equilibrium (p > 0.05); the distribution difference between the three genotypes was statistically significant (p < 0.05), the codominant, dominant and recessive distribution frequency of genotypes (p < 0.05), and no difference between A allele and C allele (p > 0.05).

CONCLUSIONS: Our study identified the relationship of AGTRA (c.1166 A>C) with hypertension combined with renal injury, and compared the susceptibility of different genetic models, which may provide novel targets for precision gene therapy of hypertension.

CLINICAL TRIAL REGISTRATION: URL: https://www.chictr.org.cn/indexEN.html; Unique identifier: ChiCTR2100051472.

PMID:37525908 | DOI:10.31083/j.fbl2807146

Cancer Med. 2023 Aug 1. doi: 10.1002/cam4.6390. Online ahead of print.

ABSTRACT

BACKGROUND: The role of endocrine therapy in the treatment of patients in a postmenopausal hormonal state and with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer (AMBC) is unclear.

METHODS: We analyzed the data from 94 patients with ER-positive HER2-positive AMBC enrolled in the Safari study (UMIN000015168), a retrospective cohort study of 1072 ER-positive AMBC patients in a postmenopausal hormonal state who received fulvestrant 500 mg (F500): (1) to compare time to treatment failure (TTF) and overall survival (OS) by treatment group, and TTF by treatment line; (2) in patients who received endocrine therapy (including F500) or anti-HER2 therapy as initial systemic therapy before chemotherapy, to investigate relations between TTF for the first-line therapy or time to chemotherapy (TTC) and OS; (3) to investigate factors associated with OS.

RESULTS: The TTF was longer in the patients treated with F500 as first- or second-line therapy (n = 20) than in those who received later-line F500 therapy (n = 74) (6.6 vs. 3.7 months; HR, 1.98; p = 0.014). In the 59 patients who received endocrine therapy or anti-HER2 therapy as initial systemic therapy before chemotherapy, those with TTC ≥3 years had longer median OS than those with TTC <3 years (10.5 vs. 5.9 years; HR, 0.32; p = 0.001). Longer TTC was associated with prolonged OS.

CONCLUSIONS: In patients with ER-positive HER2-positive AMBC enrolled in the Safari study, TTF was longer in patients who received F500 as first- or second-line therapy. In patients who received chemotherapy-free initial systemic therapy, the prolonged OS in those with TTC ≥3 years suggests that this value may be a helpful cut-off for indicating clinical outcomes.

PMID:37525895 | DOI:10.1002/cam4.6390

Cleft Palate Craniofac J. 2023 Aug 1:10556656231190525. doi: 10.1177/10556656231190525. Online ahead of print.

ABSTRACT

OBJECTIVE: Studies evaluating the ability to diagnose and accurately predict the severity of micrognathia prenatally have yielded inconsistent results. This review aimed to evaluate reliability of prenatal diagnostic imaging in the diagnosis and characterization of micrognathia.

DESIGN: Systematic review and meta-analysis.

SETTING: Studies with a prenatal diagnosis of micrognathia via ultrasound with a confirmatory postnatal examination were included. Prenatal severity was defined with and without mandibular measurements. Extent of airway obstruction at birth was defined by level of intervention required. Meta-analyses of proportions and relative risk were performed.

PATIENTS: A total of 16 studies with 2753 neonates were included.

MAIN OUTCOME MEASURES: Primary outcome was the efficacy of characterizing the degree of micrognathia on prenatal imaging as it relates to respiratory obstruction at birth. Secondary outcome was the accuracy of prenatal diagnosis with the utilization of mandibular measurements versus without.

RESULTS: Performing meta-analysis of proportions, the proportion of missed prenatal diagnoses of micrognathia made without mandibular measurements was 11.62% (95%CI 2.58-25.94). Utilizing mandibular measurements, the proportion of cases missed were statistically lower (0.20% [95%CI 0.00-0.70]). Patients determined to have severe micrognathia by prenatal imaging did not have a statistically significant increase in risk for more severe respiratory obstruction at birth (RR 3.13 [95%CI 0.59-16.55], P = .180).

CONCLUSION: The proportion micrognathia cases missed when prenatal diagnosis was made without mandibular measurements was over 1 in 10, with mandibular measures improving accuracy. This study highlights the need for a uniform objective criterion to improve prenatal diagnosis and planning for postnatal care.

PMID:37525884 | DOI:10.1177/10556656231190525

Eur Oral Res. 2023 May 4;57(2):108-114. doi: 10.26650/eor.2023978293.

ABSTRACT

PURPOSE: The aim of this in-vitro study was to evaluate the effect of thermal changes to shear bond strength during the firing process of veneering porcelain on a zirconia framework.

MATERIALS AND METHODS: Single yttria-stabilized tetragonal zirconia polycrystal (Y-TZP) framework ceramic (Kavo Dental GmbH) and three different types of veneering ceramics (IPS e.max Ceram, Vita VM9, and GC Initial Zr-FS) were used. One-hundred-twenty standard disc-shaped samples were prepared from zirconia blocks by using a CAD/CAM system (Kavo Everest). Four different cooling processes (maximum, 25°C/min, 50°C/min and 75°C/min) were applied to the veneering ceramics and the shear bond strength (SBS) test was performed. Ceramic surfaces were investigated by using scanning electron microscopeic (SEM). The possible occurrence of a t-m transformation of zirconia was evaluated by X-Ray Diffraction (XRD). Two-way analysis of variance, Bonferroni correction and paired comparisons were used for statistical analysis.

RESULTS: The main effects of veneering ceramics on shear bond strength were found to be significant (p=0.042). The mean shear bond strength values differ according to the cooling process (p<0.001). The monoclinic phase ratio increased in groups with fast cooling process.

CONCLUSION: The thermal changes during the firing process of veneering porcelain on a zirconia framework influenced the shear bond strength of the all-ceramic bilayered system. A slow cooling process provided higher strength for bilayer ceramic samples.

PMID:37525861 | PMC:PMC10387139 | DOI:10.26650/eor.2023978293

Eur Oral Res. 2023 May 4;57(2):90-95. doi: 10.26650/eor.20231083203.

ABSTRACT

PURPOSE: This study was to compare and evaluate the effect of home bleaching on the microhardness and flexural strength of microhybrid and nanohybrid composite resins.

MATERIALS AND METHODS: The study samples were prepared using a custom-made silicon rubber mold. For microhardness evaluation, 40 disc-shaped specimens (4mm*2mm) were prepared and divided into 4 groups: GROUP A (n=10): microhybrid (GC Solaire X, GC Corporation) control group, GROUP B (n=10) nanohybrid (Tetric N Ceram, Ivoclar Vivadent) control group, GROUP C (n=10): microhybrid bleaching group, GROUP D (n=10) nanohybrid bleaching group. For flexural strength evaluation, 40 bar shaped specimens (25mm*2mm*2mm) were prepared. They were divided into 4 groups, GROUP 1 (n=10): microhybrid control group, GROUP 2 (n=10) nanohybrid control group, GROUP 3 (n=10): microhybrid bleaching group, GROUP 4(n=10) nanohybrid bleaching group. All the control groups were placed in artificial saliva and bleaching groups were exposed to home bleaching agent for 14 days according to manufacturer’s instructions. The microhardness and flexural strength were evaluated for the respective specimens after 14 days and the data were statistically analyzed.

RESULTS: Home bleaching regimen decreased microhardness of both microhybrid and nanohybrid composites whereas there was no significant effect on the flexural strength. Nanohybrid composites showed greater microhardness values before and after bleaching.

CONCLUSION: Bleaching agents, irrespective of their concentration can decrease the microhardness of the composite resin samples, which raises a concern about replacement of these restorations due to the effects on physical and mechanical properties.

PMID:37525860 | PMC:PMC10387141 | DOI:10.26650/eor.20231083203

Eur Oral Res. 2023 May 4;57(2):96-102. doi: 10.26650/eor.20231163180.

ABSTRACT

PURPOSE: To evaluate and compare shear bond strength (SBS) of new and recycled metallic brackets bonded to conditioned and reconditioned enamel, using two different adhesive materials.

MATERIALS AND METHODS: 72 extracted sound human premolars were randomly divided into 6 groups. Transbond XT light cured composite (LCC) and Fuji Ortho LC resin-modified glass ionomer (RMGI), were used as adhesive materials. In groups 1 and 2 (control), new brackets were bonded to sound premolars using either LCC or RMGI, respectively. In Groups 3 and 4, new brackets were bonded to reconditioned enamel; and in groups 5 and 6, sandblasted recycled brackets were rebonded to reconditioned enamel. After 5.000 thermal cycles between 5ºC and 55ºC, SBS was evaluated and adhesive remnant on the enamel assessed using the ARI index. Statistical analyses included Shapiro-Wilk, ANOVA, Fligner-Killeen ANOVA and Tukey tests.

RESULTS: The statistical analysis showed no significant difference in SBS comparing control and experimental groups for either new or recycled brackets (p = 0.848). The SBS was significantly higher in brackets bonded with LCC (15.7 MPa) than RMGI (11.6 MPa) (p = 0.006). Adhesive failure was the most frequent, with the adhesive remnant covering more than 50% of the bracket base.

CONCLUSION: No significant differences were observed in SBS using either new or recycled brackets, regardless of the dental surface treatment (conditioned or reconditioned). Significantly higher SBS values were obtained with LCC adhesive. Adhesive failure prevails in all groups.

PMID:37525859 | PMC:PMC10387137 | DOI:10.26650/eor.20231163180