Tag: statistics

Ophthalmol Ther. 2023 Mar 4. doi: 10.1007/s40123-023-00692-2. Online ahead of print.

ABSTRACT

INTRODUCTION: Pars plana vitrectomy (PPV) is a primary strategy to restore vision for patients who have rhegmatogenous retinal detachment (RRD). Perfluorocarbon liquid (PFCL) is frequently used during PPV surgery. However, the unintended intraocular retention of PFCL may cause retina toxicity and thus lead to possible postoperative complications. In this paper, the experiences and surgical outcomes of a NGENUITY 3D Visualization System-assisted PPV are shown to evaluate the possibility of excluding the application of PFCL.

METHODS: A consecutive series of 60 cases with RRD were presented, all of whom had undergone 23-gauge PPV with the assistance of a three-dimensional (3D) visualization system. Among them, 30 cases used PFCL to assist the drainage of subretinal fluid (SRF), while the other 30 cases did not. Parameters including retinal reattachment rate (RRR), best-corrected visual acuity (BCVA), operation time, and SRF residual were compared between the two groups.

RESULTS: Baseline data showed no statistical significance between the two groups. At the last postoperative follow-up, the RRR of all the 60 cases reached 100% and best-corrected visual acuity (BCVA) gained significant improvement. The BCVA (logMAR) increased from 1.293 ± 0.881 to 0.479 ± 0.316 in the PFCL-excluded group, exhibiting better results than the PFCL included group, whose final BCVA was 0.650 ± 0.371. More importantly, excluding PFCL greatly reduced the operation time (decrease of 20%), therefore, avoiding possible complications caused by both the use of PFCL and the operation process.

CONCLUSION: With the assistance of the 3D visualization system, it is feasible to treat RRD and perform PPV without using PFCL. The 3D visualization system is highly recommendable, as not only can it achieve the same surgical effect without the assistance of PFCL, but also simplify the operation procedure, shorten the operation time, save costs, and avoid complications related to PFCL.

PMID:36869993 | DOI:10.1007/s40123-023-00692-2

Clin Pharmacokinet. 2023 Mar 4. doi: 10.1007/s40262-023-01210-0. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: In the USA, cabozantinib was approved for the treatment of patients aged ≥ 12 years with radioiodine-refractory differentiated thyroid cancer (DTC) who progressed on prior vascular endothelial growth factor (VEGFR)-targeted therapy based on the Phase 3 COSMIC-311 trial, which evaluated cabozantinib 60 mg/day versus placebo. Approved dosing is 60 mg/day for adults and for pediatric patients aged ≥ 12 years with body surface area (BSA) ≥ 1.2 m², and 40 mg/day for pediatric patients aged ≥ 12 years with BSA < 1.2 m². This report describes a population pharmacokinetic (PopPK) and exposure-response analysis of COSMIC-311.

METHODS: A PopPK model was developed using concentration-time data from COSMIC-311 and 6 other cabozantinib studies. The final (full) PopPK model was used to simulate the effect of sex, body weight, race, and patient population. For exposure-response analysis, derived datasets from COSMIC-311 were constructed for time-to-event analyses of progression-free survival (PFS) and safety endpoints.

RESULTS: The PopPK analysis included 4746 cabozantinib PK samples from 1745 patients and healthy volunteers. Body weight had minimal impact on cabozantinib exposure but increasing body weight was associated with increased apparent volume of distribution. Based on model-based simulation, adolescents < 40 kg had higher maximum plasma concentration at steady state of cabozantinib 60 mg/day compared to adults. Allometric scaling simulation in adolescents < 40 kg demonstrated higher exposure with 60 mg/day relative to adults receiving the same dose, while exposure with 40 mg/day in adolescents < 40 kg was similar to 60 mg/day in adults. The exposure-response analysis included 115 patients. There was no clear relationship between PFS or dose modification and cabozantinib exposure. A statistically significant relationship was demonstrated for cabozantinib exposure and hypertension (Grade ≥ 3) and fatigue/asthenia (Grade ≥ 3).

CONCLUSIONS: These results support the dosing strategy implemented in COSMIC-311 and the BSA-based label recommendations for adolescents. The cabozantinib dose should be reduced to manage adverse events as indicated.

PMID:36869986 | DOI:10.1007/s40262-023-01210-0

Int Ophthalmol. 2023 Mar 4. doi: 10.1007/s10792-023-02646-w. Online ahead of print.

ABSTRACT

PURPOSE: To perform a systematic evaluation of the efficacy and safety of loteprednol etabonate (LE) 0.5% versus fluorometholone (FML) 0.1% for treating patients after corneal refractive surgery with the aim of providing an evidence-based rationale for clinical drug selection.

METHODS: Electronic databases (PubMed, EMBASE, Cochrane Library, Web of Science, WanFang, and CNKI) were searched (from inception to December 2021) for comparative clinical studies that evaluated LE versus FML treatment for post-corneal refractive surgery patients. Meta-analysis was performed using the RevMan 5.3 software. The pooled risk ratio (RR) and weighted mean difference (WMD) with corresponding 95% confidence interval (CI) were calculated.

RESULTS: Nine studies with a total sample size of 2677 eyes were included in this analysis. FML 0.1% and LE 0.5% produced a similar incidence of corneal haze within 6 months after surgery (P = 0.13 at 1 month, P = 0.66 at 3 months, and P = 0.12 at 6 months). There was no statistically significant difference between the two groups in terms of the mean logMAR postoperative uncorrected distance visual acuity (WMD: – 0.00; 95% CI: – 0.01 to 0.00; P = 0.29) and spherical equivalent (WMD: 0.01; 95% CI: – 0.01 to 0.03; P = 0.35). LE 0.5% appears to have a higher tendency to reduce the incidence of ocular hypertension compared FML 0.1%, but there was no statistical significance (RR: 0.63; 95% CI: 0.27 to 1.50; P = 0.30).

CONCLUSION: This meta-analysis demonstrated that LE 0.5% and FML 0.1% had comparable efficacy in preventing corneal haze and corticosteroid-induced ocular hypertension, with no difference in visual acuity in patients after corneal refractive surgery.

PMID:36869982 | DOI:10.1007/s10792-023-02646-w

Int Ophthalmol. 2023 Mar 4. doi: 10.1007/s10792-023-02652-y. Online ahead of print.

ABSTRACT

PURPOSE: To conduct a bibliometric and altmetric analysis of the top 50 most-cited articles on small incision lenticule extraction (SMILE) surgery and assess its correlations with other metrics.

METHODS: The terms “small incision lenticule extraction” or “SMILE” were searched in the title, abstract, and keywords using Web of Science database. The retrieved articles (n = 927, between 2010 and 2022) were analyzed in-depth using altmetric attention scores (AAS), and traditional metrics (citation numbers of articles, impact factor of journals, and other citation-based metrics). A correlation statistics was performed with metrics. The articles’ focus was examined quantitatively and the most prolific parameters were identified. Authorship network and country statistics also was examined.

RESULTS: Citation numbers were between 491 and 45. AASs were between 26 and 0. The altmetric score correlated moderately with citation number (r = 0.44, P = 0.001) and annual mean citations (r = 0.49, P < 0.001), but correlated weakly with impact factor (r = 0.28, P = 0.045), and immediacy index (r = 0.32, P = 0.022). The most articles published from China and the most articles were published in 2014. Modern SMILE surgery was mostly compared to the older LASIK procedure. The highest authorship number of links belonged to Zhou XT.

CONCLUSION: The first bibliometric and altmetric analysis of SMILE research provides novel directions for future work by showing the current research trends, prolific parameters, and zones with potential for the public’s attention, providing useful information about the dissemination of scientific knowledge on SMILE in social media and to the general public.

PMID:36869979 | DOI:10.1007/s10792-023-02652-y

Int Ophthalmol. 2023 Mar 4. doi: 10.1007/s10792-023-02653-x. Online ahead of print.

ABSTRACT

PURPOSE: To investigate microcirculation characteristics of the inner retinal layers at the macula and the peripapillary area using Optical Coherence Tomography Angiography (OCT-A) of patients in early stages of Parkinson’s disease (PD).

METHODS: 32 PD patients and 46 age- and gender-matched healthy controls were included in this cross sectional study. OCT-A imaging was performed to analyze microcirculation characteristics at each separate macular region (fovea, parafovea, and perifovea) and the peripapillary area of the inner retinal layers.

RESULTS: Individuals with PD had significantly lower parafoveal, perifoveal and total vessel density (VD) in the superficial capillary plexus (SCP) than controls (all p < 0.001), while foveal VD was higher in PD eyes than that of controls, though not statistically significant. Similarly, individuals with PD had significantly lower parafoveal, perifoveal and total perfusion in the SCP than control eyes (all p < 0.001), while foveal perfusion was significantly higher in PD eyes than that of controls (p = 0.008). PD eyes had significantly smaller FAZ area and perimeter accompanied by decreased circularity at the SCP as compared to controls (all p < 0.001). Concerning the peripapillary area, individuals with PD had significantly lower radial peripapillary capillary perfusion density and flux index at the SCP than controls (all p < 0.001). All p values remained statistically significant even after using the Bonferroni correction for multiple comparisons, except for that of foveal perfusion.

CONCLUSIONS: Our study indicates alterations of the inner retinal layers at the macula and the peripapillary area at the preliminary stages of PD. OCT-A parameters could potentially comprise imaging biomarkers for PD screening and improve the diagnostic algorithms.

PMID:36869977 | DOI:10.1007/s10792-023-02653-x

Environ Sci Pollut Res Int. 2023 Mar 4. doi: 10.1007/s11356-023-25871-3. Online ahead of print.

ABSTRACT

We use a variety of organization-level datasets to examine the effectiveness and efficiency of the nations for the coronavirus epidemic. COVID-19 subsidies appear to have saved a significant number of jobs and maintained economic activity during the first wave of the epidemic, according to conclusions drawn from the experiences of EU member countries. General allocation rules may yield near-optimal outcomes in favor of allocation, as firms with high ecological footprints or zombie firms have lower access to government financing than more favorable, commercially owned, and export-inclination firms. Our assumptions show that the pandemic has a considerable negative impact on firm earnings and the percentage of illiquid and non-profitable businesses. Although they are statistically significant, government wage subsidies have a modest impact on corporate losses compared to the magnitude of the economic shock. Larger enterprises, which receive a lesser proportion of the aid, have more room to increase their trade liabilities or liabilities to linked entities. In contrast, according to our estimations, SMEs stand a greater danger of insolvency.

PMID:36869958 | DOI:10.1007/s11356-023-25871-3

Eur Child Adolesc Psychiatry. 2023 Mar 4. doi: 10.1007/s00787-023-02185-w. Online ahead of print.

ABSTRACT

The impact of adverse childhood experiences (ACEs) on adult health has been extensively examined, but the association between ACEs and sleep, emotion, behavior and academic outcomes of children and adolescents is not well known. A total of 6363 primary and middle school students were included to examine the effect of ACEs on sleep quality, emotional and behavioral problems and academic achievement and further explore the mediation role of sleep quality and emotional and behavioral problems. Children and adolescents with ACE exposure had 1.37 times risk of poor sleep quality (adjusted odds ratio [OR] = 1.37, 95% confidence interval [CI]: 1.21-1.55), 1.91 times risk of emotional and behavioral problems (adjusted OR = 1.91, 95%CI: 1.69-2.15) and 1.21 times risk of self-reported lower academic achievement (adjusted OR = 1.21, 95%CI: 1.08-1.36). Most types of ACEs were significantly associated with poor sleep quality, emotional and behavioral problems and lower academic achievement. There were dose-response relationships between cumulative ACE exposure and risk of poor sleep quality, emotional and behavioral problems, and lower academic achievement. Sleep quality and emotional and behavioral performance mediated 45.9% of the effect of ACEs exposure on math scores and 15.2% of the effect of ACEs exposure on English scores. Early detection and prevention of ACEs among children and adolescents are urgent and essential, and targeted interventions for sleep and emotional and behavioral performance as well as early educational interventions are recommended for children with ACEs exposure.

PMID:36869931 | DOI:10.1007/s00787-023-02185-w

Clin Oral Investig. 2023 Mar 4. doi: 10.1007/s00784-023-04928-0. Online ahead of print.

ABSTRACT

OBJECTIVES: To assess the behavior of dual-cure and conventional bulk-fill composite materials on real-time linear shrinkage, shrinkage stress, and degree of conversion.

MATERIALS AND METHODS: Two dual-cure bulk-fill materials (Cention, Ivoclar Vivadent (with ion-releasing properties) and Fill-Up!, Coltene) and two conventional bulk-fill composites (Tetric PowerFill, Ivoclar Vivadent; SDR flow + , Dentsply Sirona) were compared to conventional reference materials (Ceram.x Spectra ST (HV), Dentsply Sirona; X-flow; Dentsply Sirona). Light curing was performed for 20 s, or specimens were left to self-cure only. Linear shrinkage, shrinkage stress, and degree of conversion were measured in real time for 4 h (n = 8 per group), and kinetic parameters were determined for shrinkage stress and degree of conversion. Data were statistically analyzed by ANOVA followed by post hoc tests (α = 0.05). Pearson’s analysis was used for correlating linear shrinkage and shrinkage force.

RESULTS: Significantly higher linear shrinkage and shrinkage stress were found for the low-viscosity materials compared to the high-viscosity materials. No significant difference in degree of conversion was revealed between the polymerization modes of the dual-cure bulk-fill composite Fill-Up!, but the time to achieve maximum polymerization rate was significantly longer for the self-cure mode. Significant differences in degree of conversion were however found between the polymerization modes of the ion-releasing bulk-fill material Cention, which also exhibited the significantly slowest polymerization rate of all materials when chemically cured.

CONCLUSIONS: While some of the parameters tested were found to be consistent across all materials studied, heterogeneity increased for others.

CLINICAL RELEVANCE: With the introduction of new classes of composite materials, predicting the effects of individual parameters on final clinically relevant properties becomes more difficult.

PMID:36869923 | DOI:10.1007/s00784-023-04928-0

Childs Nerv Syst. 2023 Mar 4. doi: 10.1007/s00381-023-05905-4. Online ahead of print.

ABSTRACT

INTRODUCTION: Analgesia Nociception Index (ANI) as a monitor of peri-operative nociception-anti-nociception balance has not been studied in paediatric neurosurgery. The objectives were to study the correlation between ANI (Mdoloris Education system) and revised FLACC (r-FLACC) score for the prediction of acute postoperative pain in paediatric population undergoing elective craniotomies and to compare the changes in ANI values with heart rate (HR), mean arterial pressure (MAP) and surgical plethysmographic index (SPI) during various time points of intraoperative noxious stimulation and before and after opioid administration.

METHODS: This prospective observational pilot study included 14 patients between 2 and 12 years of age undergoing elective craniotomies. HR, MAP, SPI, ANI instantaneous (ANIi) and ANI mean (ANIm) values were recorded intraoperatively and before and after opioid administration. Postoperatively HR, MAP, ANIi and ANIm, and pain scores (r-FLACC scale) were recorded.

RESULTS: There was a statistically significant negative correlation between ANIi and ANIm with r-FLACC during the time course of PACU stay (r = – 0.89, p < 0.001 and r = – 0.88 and p < 0.001 respectively). Intraoperatively, in patients with ANIi values < 50, with additional fentanyl administration, there was an increasing trend in values beyond 50, which was statistically significant (p < 0.05) at 3, 4, 5 and 10 min. The trend in changes of SPI after opioid administration was not found to be significant for patients irrespective of the baseline SPI values.

CONCLUSION: The ANI is a reliable tool for objective assessment of acute postoperative pain as assessed by r-FLACC in children undergoing craniotomies for intracranial lesions. It may be used as a guide to nociception-antinociception balance during the peri-operative period in this population.

PMID:36869908 | DOI:10.1007/s00381-023-05905-4

Eur J Pediatr. 2023 Mar 4. doi: 10.1007/s00431-023-04904-6. Online ahead of print.

ABSTRACT

The aim of this study was to examine trends in serum uric acid (SUA) levels over a recent 5-year period according to age, sex, obesity, and abdominal obesity among Korean children and adolescents. We conducted a serial cross-sectional analysis using nationally representative data from the Korea National Health and Nutritional Examination Survey from 2016 to 2020. The study outcome was trends in SUA levels. SUA trends were analyzed by survey-weighted linear regression analysis considering the survey year as a continuous variable. SUA trends were also analyzed for subgroups based on age, sex, abdominal obesity, or obesity. This study included 3,554 children and adolescents aged 10-18 years. SUA increased significantly over the study period in boys (p for trend = 0.043), but not in girls (p for trend = 0.300). In age-specific analyses, SUA increased significantly in the 10-12 years group (p for trend = 0.029). After adjusting for age, SUA increased significantly in the obese group of both boys (p for trend = 0.026) and girls (p for trend = 0.023), but not in the overweight, normal, or under-weight groups of either sex. After adjusting for age, SUA increased significantly in the abdominal obesity group of boys (p for trend = 0.017) and girls (p for trend = 0.014), but not in the non-abdominal obesity group of either sex. Conclusion: In the current study, SUA levels significantly increased in both boys and girls with obesity or abdominal obesity. Further studies of the effect of SUA on health outcomes in boys and girls with obesity or abdominal obesity are needed. What is Known: • High serum uric acid (SUA) is a risk factor for various metabolic diseases, including gout, hypertension, and type 2 diabetes. What is New: • SUA levels increased in boys and the 10-12 years group of Korean children and adolescents. • SUA levels increased significantly in Korean children and adolescents with obesity or central obesity.

PMID:36869902 | DOI:10.1007/s00431-023-04904-6