Category: Statistics

Acta Psychiatr Scand. 2022 Feb 21. doi: 10.1111/acps.13417. Online ahead of print.

ABSTRACT

BACKGROUND: We report the psychometric properties of the Patient-Reported Impact of Symptoms in Schizophrenia Scale (PRISS), which assesses the impact of subjective experiences or qualia in outpatients with this condition.

METHODS: A cross-sectional study was carried out in 162 patients diagnosed with schizophrenia in Spain. The PRISS measures the presence, frequency, concern and interference with daily life of self-reported experiences related to the main symptoms observed in these patients. The psychometric analysis included test-retest reliability, internal consistency and structural and convergent validity.

RESULTS: The 28-item PRISS showed good test-retest reliability as 64.3% of the intraclass correlation coefficient values were between 0.40 and 0.79, which were statistically significant (p<0.01). Analysis of the structural validity revealed a three-factor structure, 1) productive subjective experiences, 2) affective-negative subjective experiences and 3) excitation, which accounted for 56.11% of the variance. Of the Pearson’s correlation coefficients analysed between the PRISS and the Positive and Negative Syndrome Scale (PANSS), Scale for Assessment of Negative Symptoms (SANS) and World Health Organization Disability Assessment Schedule (WHO-DAS), 72.2% were statistically significant (p<0.05) and ranged from: 0.38-0.42, 0.32-0.42 and 0.40-0.42 respectively.

CONCLUSION: Our results indicate that the PRISS appears to be a brief, reliable and valid scale to measure subjective experiences in schizophrenia and provides valuable information complementary to clinical evaluation.

PMID:35188673 | DOI:10.1111/acps.13417

Stat Med. 2022 Feb 21. doi: 10.1002/sim.9291. Online ahead of print.

NO ABSTRACT

PMID:35188678 | DOI:10.1002/sim.9291

Laryngoscope. 2022 Feb 21. doi: 10.1002/lary.30054. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to evaluate functional and aesthetic patient-reported outcomes using validated metrics after component dorsal hump reduction (DHR) with spreader graft placement, which have not been previously reported.

STUDY DESIGN: Prospective cohort study.

METHODS: This prospective cohort study was conducted in a tertiary care medical center. Participants underwent septorhinoplasty (SRP) with spreader graft placement with cosmetic, component DHR (cosmetic DHR), or SRP with spreader graft placement without dorsal hump reduction (noncosmetic, non-DHR). The Nasal Obstruction Symptom Evaluation (NOSE) scale and the FACE-Q Satisfaction with Nose, Nostrils, and Social Functioning scales were administered to patients preoperatively and postoperatively (at 2, 4, 6, and/or 12 months). Pre- and postoperative NOSE and FACE-Q scores were compared.

RESULTS: A total of 226 patients underwent SRP with spreader graft placement; 113 (50.0%) with cosmetic DHR and 113 (50.0%) noncosmetic, non-DHR (control). Patients who completed the NOSE and FACE-Q surveys preoperatively and at least at one postoperative time point were included. Both cohorts had a statistically and clinically significant improvement in NOSE and FACE-Q scores. There were similar improvements in NOSE scores in both cohorts. Postoperative FACE-Q scores were higher in the cosmetic DHR cohort despite lower preoperative FACE-Q scores when compared to the control cohort.

CONCLUSIONS: Although there are multiple techniques for DHR, component DHR with spreader graft placement has long been considered the standard. Therefore, it is important to note the significant postoperative cosmetic and functional improvements reported by patients who have undergone this procedure to compare to newer techniques as they evolve.

LEVEL OF EVIDENCE: 3 Laryngoscope, 2022.

PMID:35188669 | DOI:10.1002/lary.30054

Pediatr Blood Cancer. 2022 Feb 21:e29616. doi: 10.1002/pbc.29616. Online ahead of print.

ABSTRACT

PURPOSE: We sought to analyze biologic, clinical, and prognostic differences according to pattern of failure at the time of first relapse in neuroblastoma.

PATIENTS AND METHODS: Children <21 years diagnosed with neuroblastoma between 1989 and 2017 with known site of first relapse (isolated local vs. distant only vs. combined local and distant sites) were identified from the International Neuroblastoma Risk Group (INRG) database. Data were compared between sites of relapse according to clinical features, biologic features, initial treatment, time to first relapse, and overall survival (OS) from time of first relapse.

RESULTS: Pattern of first relapse among 1833 children was 19% isolated local; 65% distant only; and 16% combined sites. All evaluated clinical and biologic variables with exception of tumor diagnosis differed statistically by relapse pattern, with patients with isolated local failure having more favorable prognostic features. Patients with stage 3 disease were more likely to have isolated local failure compared to all other stages (49% vs. 16%; p < .001). OS significantly differed by relapse pattern (5-year OS ± SE): isolated local: 64% ± 3%; distant only: 23% ± 2%; and combined: 26% ± 4% (p < .001). After controlling for age, stage, and MYCN status, patients with isolated local failure (adjusted hazard ratio [HR] = 0.46; 95% confidence interval [CI]: 0.33-0.62; p < .001) and distant-only failure (adjusted HR = 0.57; 95% CI: 0.45-0.71; p < .001) remained at decreased risk for death as compared to patients with combined failure.

CONCLUSION: Patients with distant-only and combined failures have a higher proportion of unfavorable clinical and biological features, and a lower survival than those with isolated local relapse.

PMID:35188340 | DOI:10.1002/pbc.29616

Catheter Cardiovasc Interv. 2022 Feb 21. doi: 10.1002/ccd.30134. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate transcatheter aortic valve replacement (TAVR) operator procedural volumes, and describe temporal and geographic trends.

BACKGROUND: TAVR is the standard of care for most patients with severe symptomatic aortic stenosis. Despite an association between operator procedural volume and outcomes, nationwide TAVR operator volumes have been incompletely described.

METHODS: We queried the National Medicare Provider Utilization and Payment Database for transfemoral TAVRs from 2014 to 2018. Annual operator volume, state and regional volumes, and longitudinal trends were extracted and analyzed using descriptive statistics.

RESULTS: In 2018, the mean annual operator volume was 23.6 TAVRs. The highest 1% of operators by volume performed 7.6% of total TAVR procedures in the United States, while 35.7% of operators performed 10 or fewer TAVRs per year. From 2014 to 2018, there was a 53.9% annualized increase in TAVRs, and the mean annual volume per operator grew from 12.5 to 23.6. There was more than five-fold variability in the density of operators (range 0.35-1.79 operators per 100,000 population) and mean operator volume by state (range 14.2-52.4 TAVRs per operator).

CONCLUSIONS: In this nationally representative study of operators performing transfemoral TAVRs among Medicare patients, we found the mean annual volume of TAVR in 2018 to be 23.6 and has increased since 2014. There was considerable variability in operator density and procedural volumes, with a significant proportion of operators performing 10 or fewer TAVRs per year. Ambiguity remains in regard to the optimal balance of procedural requirements to sustain high efficacy outcomes and ensure critical access to TAVR therapies.

PMID:35188321 | DOI:10.1002/ccd.30134

Environ Toxicol Chem. 2022 Feb 21. doi: 10.1002/etc.5312. Online ahead of print.

ABSTRACT

Understanding the bioaccumulation of engineered nanomaterials (ENMs) is essential for regulatory decisions on potential environmental risks. Research in the field of ENMs bioaccumulation has increased in recent years, but the compilation and statistical analysis of the available experimental data has not been updated. We therefore performed a meta-analysis of the existing literature on the bioaccumulation of eight types of non-dissolvable ENMs (TiO₂ , Al₂ O₃ , Au, C₆₀ , fullerenes, carbon nanotubes, FeO_x , graphene, polystyrene) in non-mammalian freshwater aquatic organisms across three trophic levels including phytoplankton, zooplankton and fish. Three typical endpoints were used to assess the bioaccumulation potential: the bioconcentration factor (BCF), the bioaccumulation factor (BAF) and the biomagnification factor (BMF). Our results suggest that zooplankton has greater mean logarithmic BCF and BAF values than phytoplankton (3.31 vs. 1.42) and fish (2.04). ENMs are biomagnified in zooplankton with a mean BMF of 17.4 whereas trophic transfer from primary consumers (zooplankton) to secondary consumers (fish) is not observed (mean BMF of 0.13). No clear dependency was identified between the physico-chemical characteristics of ENMs (e.g. primary particle size, zeta potential, or shape) and bioaccumulation, except for coated vs. uncoated particles accumulated in phytoplankton. Carbonaceous ENMs were found to be more bioaccumulated than the other considered ENMs, except TiO₂ . The meta-analysis of bioaccumulation data can i) deepen the understanding of bioconcentration, bioaccumulation and biomagnification of ENMs, ii) be used to support grouping strategies as a basis for a safer-by-design approach for ENMs, iii) be integrated into comprehensive hazard and risk assessments, iv) promote the standardization of testing guidelines, and v) enhance the future kinetic bioaccumulation modelling. This article is protected by copyright. All rights reserved. © 2022 SETAC.

PMID:35188281 | DOI:10.1002/etc.5312

Vet Radiol Ultrasound. 2022 Feb 21. doi: 10.1111/vru.13072. Online ahead of print.

ABSTRACT

Magnetic resonance imaging is increasingly available for evaluation of horses with suspected pituitary adenomas; however, published studies describing the MRI features of normal equine pituitary glands are currently lacking. This retrospective, descriptive, anatomic study describes the MRI appearance and size of presumed normal equine pituitary glands and assesses potential correlations between pituitary size, brain size, and patient weight. These findings serve as a reference for MRI evaluation of the equine pituitary gland. Inclusion criteria consisted of adult horses (2-15 years old), over 300 kg with no evidence of Pituitary pars intermedia dysfunction (PPID) and no pituitary abnormalities identified with MRI, yielding 27 horses. Histology was available on seven pituitary glands; all were considered normal by a board-certified anatomic pathologist. Imaging features of the glands were evaluated on T2-weighted and pre- and postcontrast T1-weighted images. Pituitary length, width, and height and brain height and width were measured by two authors on transverse and mid-sagittal plane postcontrast T1 weighted images. The mean ± SD pituitary gland width was 21.0 ± 2.4 mm, height: 10.4 ± 1.9 mm, and length: 24.5 ± 2.7 mm. There were no significant correlations using a Pearson’s correlation coefficient between pituitary and brain measurements, pituitary measurement, and body weight, or between brain measurements and body weight. A statistical difference was not identified using an unpaired t-test (p > 0.05) in pituitary and brain measurements between necropsied and non-necropsied horses. Relative to the cerebral white matter, all pituitary glands were isointense to slightly hyperintense on T1-weighted images and isointense on T2-weighted images, with the exception of a focal T1-weighted hyperintensity that was present in the caudal aspect of the pituitary gland in 88% of horses. All pituitary glands were homogenously contrast enhancing. Pituitary dimensions did not correlate with either brain size or body weight in horses.

PMID:35188303 | DOI:10.1111/vru.13072

Biometrics. 2022 Feb 21. doi: 10.1111/biom.13646. Online ahead of print.

ABSTRACT

In functional data analysis for longitudinal data, the observation process is typically assumed to be non-informative, which is often violated in real applications. Thus, methods that fail to account for the dependence between observation times and longitudinal outcomes may result in biased estimation. For longitudinal data with informative observation times, we find that under a general class of shared random effect models, a commonly used functional data method may lead to inconsistent model estimation while another functional data method results in consistent and even rate-optimal estimation. Indeed, we show that the mean function can be estimated appropriately via penalized splines and that the covariance function can be estimated appropriately via penalized tensor-product splines, both with specific choices of parameters. For the proposed method, theoretical results are provided, and simulation studies and a real data analysis are conducted to demonstrate its performance. This article is protected by copyright. All rights reserved.

PMID:35188270 | DOI:10.1111/biom.13646

J AOAC Int. 2022 Feb 21:qsac023. doi: 10.1093/jaoacint/qsac023. Online ahead of print.

ABSTRACT

BACKGROUND: In collaboration with the Office of Dietary Supplements at the National Institutes of Health, the National Institute of Standards and Technology issued a suite of botanical matrix Reference Materials (RMs) and Standard Reference Material® (SRM) for determination of isoflavones and toxic elements in kudzu dietary supplement ingredients.

OBJECTIVE: RM 8650 Pueraria montana var. lobata (Kudzu) Rhizome, SRM 3268 Pueraria montana var. lobata (Kudzu) Extract, and RM 8652 Kudzu-Containing Solid Oral Dosage Form were issued with values assigned for isoflavones (puerarin, daidzin, and daidzein), toxic elements (arsenic, cadmium, and lead), and selenium.

METHODS: Isoflavone values were assigned using liquid chromatography with UV absorbance or mass spectrometry detection. Element values were assigned using inductively coupled plasma mass spectrometry and results from an interlaboratory comparison exercise.

RESULTS: Mass fractions for puerarin were (32.2 ± 3.2) mg/g, (128 ± 13) mg/g, and (68.2 ± 6.9) mg/g in RM 8650, SRM 3268, and RM 8652, respectively. Arsenic increases from (156 ± 14) ng/g to (849 ± 83) ng/g and cadmium decreases from (348 ± 14) ng/g to (82.1 ± 4.9) ng/g from rhizome to extract.

CONCLUSION: The kudzu RM/SRM suite complements previously issued soy-related SRMs with values assigned for isoflavones, which have been studied for their potential health benefits, and expands the analytical resource by providing values for puerarin, an isoflavone not found in soy.

HIGHLIGHTS: The three new kudzu materials are for use in the determination of isoflavones, toxic elements, and selenium. For the isoflavones, these new kudzu materials provide higher levels of daidzin and daidzein than existing soy-related SRMs, and they provide a value for an isoflavone not in existing SRMs (puerarin). Toxic elements in RM 8650 and SRM 3268 provide new botanical matrices for use by dietary supplement manufacturers for the verification of the safety of their raw materials.

PMID:35188206 | DOI:10.1093/jaoacint/qsac023

J Natl Cancer Inst. 2022 Feb 21:djac046. doi: 10.1093/jnci/djac046. Online ahead of print.

ABSTRACT

Although indications for immune checkpoint inhibitors (ICIs) have dramatically increased in the past decade, ICIs have been associated with autoinflammatory immune-related adverse events which can resemble autoimmune diseases (ADs). Little is known about the impact of baseline AD on mortality in cancer patients treated with ICIs. Here, we identified 17,497 patients with pre-existing autoimmune diagnoses prior to treatment with anti-PD-1 or anti-PD-L1 therapy and 17,497 matched controls through the TriNetX Diamond network of over 200 million patients across the US and Europe. Using a Cox proportional hazards model, we found that patients with history of AD were not at higher risk of mortality than non-AD controls (HR, 1.03; 95% CI, 1-1.07; p = 0.05). Additionally, history of Hashimoto’s disease (HR, 0.75; 95% CI, 0.62-0.90; p = 0.002) and vitiligo (HR,0.52; 95% CI, 0.34-0.81; p = 0.003) were statistically significantly associated with decreased mortality. This suggests that underlying AD need not be a contraindication to inclusion in clinical trials and administration of ICI for treatment of cancer.

PMID:35188215 | DOI:10.1093/jnci/djac046