Tag: statistics

Early Hum Dev. 2021 Aug 30;161:105454. doi: 10.1016/j.earlhumdev.2021.105454. Online ahead of print.

ABSTRACT

BACKGROUND: Preterm children obtain worse scores in tests that evaluate visuospatial functions. Pascual’s graphomotor test (PGMt) assesses maturity in copying drawings in childhood, quickly evaluating the graphomotor aptitude that is a partial aspect of non-verbal intelligence.

AIMS: To evaluate visuospatial functions in preterm children compared to full-term children. To assess the capacity of the Pascual graphomotor test (PGMt) to detect visuospatial disorders more specifically than non-verbal intelligence quotient (IQ).

STUDY DESIGN AND SUBJECTS: case and control study.

CASES: preterm children between 5 and 11 years of age without cognitive delay; controls: full-term children with the same characteristics. For each child clinical history, neurological examination, language-free intelligence test Toni 2 (IQ) and Pascual’s graphomotor test (PGMt) were carried out.

RESULTS: 135 children were enrolled (59 cases vs. 79 controls). The mean age was 7.4 years. 55% were male. The mean gestational age of cases was 30.5 weeks with 34% extremely preterm. Cases obtained worse mean scores in both tests. The mean IQ scores were: cases 117.4, controls 125.0 (p = 0.004). The mean graphomotor quotient (GQ) scores were statistically and clinically significant (cases 76.8; controls 98.3, p = 0.001). Although we have found a positive correlation between IQ and GQ scores (cc = 0.31 p = 0.01), the differences found in the GQ between groups have been maintained regardless of the IQ in the multivariate analysis (GQ: cases 78.3 (SD 14.8), controls 98.3 (SD 12.5), p = 0.04).

CONCLUSIONS: GQ is a useful tool for screening for visuospatial anomalies. GQ more specifically measures the visuoperceptive disorder regardless of non-verbal cognitive level.

PMID:34496347 | DOI:10.1016/j.earlhumdev.2021.105454

J Oral Maxillofac Surg. 2021 Aug 10:S0278-2391(21)00754-0. doi: 10.1016/j.joms.2021.08.002. Online ahead of print.

ABSTRACT

PURPOSE: Coronoidectomy is carried out frequently as a part of the cranial-maxillofacial surgery procedure. There are few articles on the fate of coronoid process after coronoidectomy, except that several case reports mentioned that coronoid process had regenerated. This study aimed to radiographically access the anatomic outcomes of coronoid process and investigate which factors were associated with the outcomes after coronoidectomy.

MATERIALS AND METHODS: A retrospective cohort study included patients undergoing coronoidectomy over a 7-year period. The primary outcome variable was the new coronoid process occurrence (yes/no). Secondary outcome variable was the type of the new coronoid process by evaluating its size, shape and position. Radiograph at 1-year postoperative visit was used to determine the outcomes. The predictor variables included age, sex, surgical purpose, surgical side, surgical approach and the maximal interincisal opening. Appropriate statistics were analyzed by SPSS version 22. χ² test and binary logistic regression were used to assess the association between predictor factors and anatomic outcomes (P <.05).

RESULTS: The study sample included 57 patients. In total, 96 coronoidectomies were performed. Seventy-four coronoid processes (77.1%) showed complete (n = 44, 45.8%), nonunion (n = 19, 19.8%) or partial (n = 11, 11.5%) regrowth, whereas no evidence of regeneration in 22 sites was observed radiographically at 1-year postoperative visit. Binary logistic regression showed that a young age (odds ratio 0.704; 95% confidence interval 0.562-0.882; P = .002) was significantly associated with regeneration of coronoid process.

CONCLUSIONS: Coronoid process can mostly regenerate after coronoidectomy. A young age may contribute to regrowth of coronoid process.

PMID:34496291 | DOI:10.1016/j.joms.2021.08.002

J Mech Behav Biomed Mater. 2021 Aug 24;124:104794. doi: 10.1016/j.jmbbm.2021.104794. Online ahead of print.

ABSTRACT

The mechanical properties of normal soft tissues, including breast tissue, have been of interest to the biomedical research community as there are many clinical and industrial applications that can benefit from quantitative information characterizing such properties. For instance, computer assisted surgery planning, elastography for breast cancer diagnosis, and bra design can all involve biomechanical modeling of the breast to predict its deformation or stress distribution. It is known that most biological soft tissues, including breast tissue, exhibit nonlinear mechanical response over large strains. As such, it is necessary to model such tissues as hyperelastic. In this work, we used indentation testing to estimate the hyperelastic parameters of 4 models (3rd order Ogden, 5-term polynomial, Veronda-Westman and Yeoh) estimated from 72 healthy ex vivo breast tissue samples covering adipose, fibroglandular, and mixed tissue. All estimated parameter sets were confirmed to represent stable material using Drucker’s stability criterion. We observed that all three tissue types were statistically similar solidifying the use of homogenous breast modelling over large strain simulation.

PMID:34496308 | DOI:10.1016/j.jmbbm.2021.104794

Clin Biochem. 2021 Sep 5:S0009-9120(21)00229-0. doi: 10.1016/j.clinbiochem.2021.09.001. Online ahead of print.

ABSTRACT

BACKGROUND: Differences in biomarkers reflective of pathobiology and prognosis between ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) are incompletely understood and may offer insights for tailoring of treatment.

METHODS: This registry-based study included 538 STEMI and 544 NSTEMI patients admitted 2008-2014. Blood samples were collected day 1-3 after admission and 175 biomarkers were analyzed using Proximity Extension Assay and Multiple Reaction Monitoring mass spectrometry. Adjusted Lasso analysis (penalized logistic regression model) was used to select biomarkers that discriminated STEMI from NSTEMI patients. Biomarkers identified by the Lasso analysis were then evaluated in adjusted Cox regressions for associations with death or major adverse cardiovascular events.

RESULTS: Biomarkers strongly discriminated STEMI and NSTEMI when considered simultaneously in adjusted Lasso analysis (c-statistic 0.764). Eleven biomarkers independently discriminated STEMI and NSTEMI; seven showing higher concentrations in STEMI: myoglobin, N-terminal pro-B-type natriuretic peptide, serum amyloid A-1 and A-2 protein, ST2 protein, interleukin-6 and chitinase-3-like protein 1; and four showing higher concentrations in NSTEMI: fibroblast growth factor 23, membrane-bound aminopeptidase P, tumor necrosis factor-related activation-induced cytokine and apolipoprotein C-I. During up to 6.6 years of prognostic follow-up, none of these biomarkers exhibited different associations with adverse outcome between STEMI and NSTEMI.

CONCLUSIONS: In the acute setting, biomarkers indicated greater myocardial dysfunction and inflammation in STEMI, whereas they displayed a more diverse pathophysiologic pattern in NSTEMI patients. These biomarkers were similarly prognostic in STEMI and NSTEMI patients. The results do not support treating STEMI and NSTEMI patients differently based on the concentrations of these biomarkers.

PMID:34496288 | DOI:10.1016/j.clinbiochem.2021.09.001

BJU Int. 2021 Sep 8. doi: 10.1111/bju.15593. Online ahead of print.

ABSTRACT

OBJECTIVE: This paper describes a novel syphoning ureteral access sheath (UAS) intended for use during flexible uretero-renoscopy (URS). We aimed to assess if in vitro it could reduce intrarenal pressure (IRP) and increase irrigation flow compared to traditional UAS.

METHODS: A validated phantom kidney with fiber optic pressure sensing capabilities was used to assess IRP. Standardized 80cm H₂ 0 irrigation via a ureterorenoscope was instilled through a traditional (11/13 Fr and 12/14 Fr) UAS and compared to the novel 11/13Fr syphoning UAS. Measured minute volume, calculated hourly flow volume and steady state IRP were compared.

RESULTS: The traditional 11/13 Fr and 12/14 Fr UAS has statistically poorer irrigation flow compared to the novel syphoning UAS of 19,3 vs 29,3ml/min (p=0.0004) and 22,7 vs 29,3ml/min (p=0.0021) respectively. The steady state IRP were 20mmHg for the traditional 11/13Fr and 13mmHg for the 12/14Fr compared to 0mmHg for the novel UAS.

CONCLUSION: The described novel UAS is different from traditional devices by incorporating a syphon mechanism. Our in vitro assessment demonstrates that the novel UAS holds clinical potential to reduce IRP while allowing a significant increase in irrigant flow compared to larger diameter traditional UAS.

PMID:34496125 | DOI:10.1111/bju.15593

J Cosmet Dermatol. 2021 Sep 8. doi: 10.1111/jocd.14446. Online ahead of print.

ABSTRACT

BACKGROUND: Psoriasis is a chronic inflammatory hyper proliferative skin disease. Angiogenesis play an important role in Psoriasis pathogenesis, occurring even before plaque formation. Angiopoietins play an important role in angiogenesis and hence are described as angiogenic factors.

AIMS: To evaluate serum levels of angiopoeitin 2 (Ang-2) following treatment with narrowband ultraviolet B (NBUVB) in patients with moderate-severe plaque psoriasis and correlate it to psoriasis area and severity index (PASI).

PATIENTS/METHODS: This cross sectional study included 38 patients complaining of moderate to severe plaque psoriasis and 38 healthy controls. Psoriasis area and severity index (PASI) was determined and was correlated to serum levels of Ang-2 before and after treatment with NBUVB.

RESULTS: PASI scores and serum values of angiopoietin 2 demonstrated a significant difference between the baseline and at the end of the 12 weeks NBUVB treatment. A statistically significant positive correlation was established between psoriasis severity and Ang-2 serum levels before and after treatment.

CONCLUSION: The study demonstrated a potential contribution of Ang-2 in the pathogenesis of psoriasis, as well as its usefulness as a biomarker of psoriasis severity.

PMID:34496134 | DOI:10.1111/jocd.14446

Mol Nutr Food Res. 2021 Sep 8:e2100389. doi: 10.1002/mnfr.202100389. Online ahead of print.

ABSTRACT

SCOPE: The polyphenol xanthohumol (XN) improves dysfunctional glucose and lipid metabolism in diet-induced obesity animal models. Because XN changes intestinal microbiota composition, we hypothesized that XN requires the microbiota to mediate its benefits.

METHODS AND RESULTS: To test our hypothesis, we fed conventional and germ-free male Swiss Webster mice either a low-fat diet (10% fat derived calories), a high-fat diet (60% fat derived calories), or a high-fat diet supplemented with XN at 60 mg/kg body weight per day for 10 weeks, and measured parameters of glucose and lipid metabolism. In conventional mice, we discovered XN supplementation decreased plasma insulin concentrations and improved Homeostatic Model Assessment of Insulin Resistance. In germ-free mice, XN supplementation failed to improve these outcomes. Fecal sample 16S rRNA gene sequencing analysis suggested XN supplementation changes microbial composition and dramatically alters the predicted functional capacity of the intestinal microbiota. Furthermore, the intestinal microbiota metabolizes XN into bioactive compounds, including dihydroxanthohumol, an anti-obesogenic compound with improved bioavailability.

CONCLUSION: XN requires the intestinal microbiota to mediate its benefits, which involves complex diet-host-microbiota interactions with changes in both microbial composition and functional capacity. Our results warrant future metagenomic studies, which will provide insight into complex microbe-microbe interactions, and diet-host-microbiota interactions. This article is protected by copyright. All rights reserved.

PMID:34496124 | DOI:10.1002/mnfr.202100389

Pharm Stat. 2021 Sep 8. doi: 10.1002/pst.2168. Online ahead of print.

ABSTRACT

Phase II immuno-oncology clinical trials screen for efficacy an increasing number of treatments. In rare cancers, using historical control data is a pragmatic approach for speeding up clinical trials. The drop-the-losers design allows dropping off ineffective arms at interim analyses. We extended the original drop-the-losers design for a time-to-event outcome using a historical control through the one-sample log-rank statistic. Simulated trials featured three arms at the first stage, one at the second stage, nine scenarios, eight sample sizes with 5%- and 10%- nominal family-wise error rate (FWER). A numerical algorithm is provided to solve power calculations at the design stage. Our design was compared with a group of three independent single-arm trials (fixed design) with and without correction for multiplicity. Our design allowed strict control of the FWER at nominal levels while the misspecification of survival distribution and fixed design inflated the FWER up to three times the nominal level. The empirical power of our design increased with the sample size, the treatment effect and the number of effective treatments and dropped when more patients were recruited at the second stage. The fixed design with correction showed comparable power, while our design advantageously included more patients to the most promising arm. Recommendations for future applications are given. By taking advantage of the use of historical control data and a time-to-event outcome, the drop-the-losers design is a promising tool to meet the challenge of improving phase II clinical trials in immuno-oncology.

PMID:34496117 | DOI:10.1002/pst.2168

Clin Transplant. 2021 Sep 8:e14475. doi: 10.1111/ctr.14475. Online ahead of print.

ABSTRACT

INTRODUCTION: Transplantation of right kidneys can pose technical challenges due to the short right renal vein. Whether this results in inferior outcomes remains controversial.

METHOD: Healthcare Database Advanced Search (HDAS) was used to identify relevant studies. Two authors independently reviewed each study. Statistical analyses were performed using random effects models and results expressed as HR or relative risk (RR) with 95% confidence intervals. Subgroup analyses were performed in kidneys from deceased donors (DD) and living donors (LD).

RESULTS: 35 studies (257,429 participants) were identified. Both deceased and living donor right kidneys were at increased risk of delayed graft function (DGF; RR = 1.12[1.06-1.18] and RR = 1.33[1.21-1.46] respectively; both p<0.0001). In absolute terms, for each 100 kidney pairs of DD kidneys transplanted there are 2.72 (1.67-3.78, p<0.00001) excess episodes of DGF in right kidneys. Graft thromboses and graft loss due to technical failure was also significantly more likely in right kidneys, in both DD and LD settings. There was no evidence that laterality alters long term graft survival in LD or DD.

CONCLUSION: Right kidneys have inferior early outcomes, with higher rates of DGF, technical failure and graft thrombosis. However, these differences are small in absolute terms, and long-term graft survival is equivalent. This article is protected by copyright. All rights reserved.

PMID:34496090 | DOI:10.1111/ctr.14475

J Prosthodont. 2021 Sep 8. doi: 10.1111/jopr.13421. Online ahead of print.

ABSTRACT

PURPOSE: This study compared the clinical outcome of dental implants and their implant-supported restorations over a three year period involving patients both positive and negative for the human immunodeficiency virus.

MATERIALS AND METHODS: Twenty patients testing positive for the human immunodeficiency virus were recruited for this study. Twenty-one negative control patients were also selected, for a total of 41 patients. Diagnostic impressions were collected and cone beam computed tomography images were obtained. Implant size and positioning were planned using cone beam computed tomography software. Two stage or single surgery was performed as determined by the surgeon (periodontist). After a six month healing period, definitive impressions were fabricated using polyvinyl siloxane impression material. Implant stability quotient values were obtained at the time of surgery and placement of the restoration. Screw retained custom titanium abutments were designed, milled, and placed with 25 N·cm torque using a calibrated torque controller. Porcelain fused-to-metal complete coverage restorations were then cemented with elastomeric resin implant cement. Implants and restorations were assessed at 6 month intervals over a period of 3 years for stability, peri-implant health, and patient satisfaction.

RESULTS: Over the three year period, 25 of 42 implants placed in the negative control group were assessed, and 17 of 27 implants placed in the positive control group were evaluated. The overall patient retention rate was 77 percent. At the three year follow up, restorations examined were fully functional and causing no pain. Overall implant retention within the positive group was 96 percent. Implant retention within the negative control group was 100 percent. No differences were noted between groups for bone loss based on statistical tests.

CONCLUSION: Within the limitations of this clinical investigation, the presence of human immunodeficiency virus per se was not a contraindication to dental treatment with implant-supported restorations. This article is protected by copyright. All rights reserved.

PMID:34496113 | DOI:10.1111/jopr.13421