Tag: statistics

Cyberpsychol Behav Soc Netw. 2024 Feb 26. doi: 10.1089/cyber.2023.0386. Online ahead of print.

ABSTRACT

Problematic social media use (PSMU) can have profound and detrimental effects across various domains of life. As a result, scientific investigations into the risk factors associated with this phenomenon can hold substantial practical implications within the clinical and preventive realms. Consistently with this framework, this study aimed to examine the relationship between certain variables and PSMU, with a specific focus on alexithymia, defense mechanisms, and fear of missing out (FoMO). A sample of 340 young adults (M_age = 26.42 years; SD = 3.689) completed an online survey, including the Bergen Social Media Addiction Scale, FoMO scale, 40-Item Defense Style Questionnaire, and 20-Item Toronto Alexithymia Scale. Results showed a statistically significant mixed serial-parallel mediation model. A significant total effect in the association between alexithymia and FoMO emerged. Furthermore, defense mechanisms and FoMO significantly and totally mediated this relationship. These findings have the potential to provide valuable insights in the field of clinical research on PSMU, and can offer practical information for enhancing clinical practice.

PMID:38407872 | DOI:10.1089/cyber.2023.0386

JAMA Pediatr. 2024 Feb 26. doi: 10.1001/jamapediatrics.2023.6630. Online ahead of print.

ABSTRACT

IMPORTANCE: No approved treatment exists for allergen-specific immunoglobulin E (IgE)-mediated cow’s milk allergy (CMA), a common childhood food allergy.

OBJECTIVE: To assess dose, efficacy, and safety of epicutaneous immunotherapy with Viaskin milk in children with IgE-mediated CMA.

DESIGN, SETTING, AND PARTICIPANTS: A phase 1/2, 2-part, randomized, double-blind, placebo-controlled dose-ranging clinical trial in children aged 2 to 17 years with IgE-mediated CMA was conducted between November 2014 through December 2017. It took place at 17 trial sites in the US and Canada. Current CMA was confirmed by double-blind, placebo-controlled food challenge at study entry. Part A assessed the short-term safety of 150 μg, 300 μg, or 500 μg of Viaskin milk; part B evaluated the efficacy and safety of the 3 doses vs placebo over 12 months of treatment. Of the 308 screened participants with physician-diagnosed CMA, 198 met eligibility criteria (including an eliciting dose 300 mg or less) and were randomized.

INTERVENTION: Safety of Viaskin milk (150-μg, 300-μg, or 500-μg doses) was evaluated over a 3-week period (part A). In part B, 180 additional participants were randomized to receive Viaskin milk at doses of 150 μg, 300 μg, or 500 μg or placebo (1:1:1:1) for 12 months.

MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of treatment responders, defined as a 10-fold or more increase in the cumulative reactive dose of cow’s milk protein (reaching at least 144 mg) or a cumulative reactive dose of cow’s milk protein at 1444 mg or more at the month 12 double-blind, placebo-controlled food challenge.

RESULTS: A total of 95.5% of the randomized participants (mean [SD] age, 8 [4.17] years; 124 of 198 were male [62.6%]) completed treatment. The highest response rate was observed in participants who received Viaskin milk at the 300-μg dose with 24 of 49 responders (49.0%) overall vs 16 of 53 responders (30.2%) in the placebo group (odds ratio, 2.19; 95% CI, 0.91-5.41; P = .09), highest in the 2 to 11 years age group (22 of 38 [57.9%] vs 13 of 40 [32.5%]; P = .04). Most treatment-emergent adverse events were mild or moderate application-site reactions. One participant in the 500-μg Viaskin milk dose group experienced treatment-related anaphylaxis.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, 12 months of daily epicutaneous immunotherapy with a dose of Viaskin milk at 300 μg was associated with a statistically significant treatment response in 2- to 11-year-old children with IgE-mediated CMA. Treatment-related anaphylaxis and treatment-related discontinuation rates were low. Further research is needed to explore Viaskin milk as a viable treatment option for children with IgE-mediated CMA.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02223182.

PMID:38407859 | DOI:10.1001/jamapediatrics.2023.6630

Eur J Gastroenterol Hepatol. 2024 Feb 23. doi: 10.1097/MEG.0000000000002722. Online ahead of print.

ABSTRACT

OBJECTIVE: The uncertain treatment duration for nucleos(t)ide analogues (NA) used in the treatment of chronic hepatitis B (CHB) is an important problem for both patients and physicians. The aim of this study was to evaluate the determinants of virologic relapse (VR) and the optimum time of treatment discontinuation in the follow-up of CHB patients who voluntarily discontinued treatment after virological suppression was achieved under NA use.

METHODS: Data from 138 patients from 11 centers were included in this registry-based study. Factors associated with VR were investigated using multivariate Cox regression analysis.

RESULTS: Ninety-nine (71.7%) of the patients were HBeAg (Hepatitis B e antigen) negative. During the 24-month follow-up period after treatment discontinuation, VR occurred in 58.7% (n = 81) of all patients and 57.6% (n = 57) of HBeAg-negative patients. The duration of NA treatment was significantly shorter (cutoff 60 months) in HBeAg-negative patients who later developed VR. In addition, the duration of virologic remission achieved under NA treatment was significantly shorter (cutoff 52 months) in those who later developed VR. In the Cox multivariate regression model of HBeAg-negative patients, having less than 60 months of NA treatment (HR = 2.568; CI:1.280-5.148; P = 0.008) and the levels of alanine aminotransferase being equal to or higher than twice the upper level of normal at the beginning of treatment (HR = 3.753; CI:1.551-9.081; P = 0.003) were found to be statistically significant and independently associated with VR.

CONCLUSION: The findings of this study may provide clinical guidance in terms of determining the most appropriate discontinuation time for NA.

PMID:38407855 | DOI:10.1097/MEG.0000000000002722

Clin J Am Soc Nephrol. 2024 Feb 26. doi: 10.2215/CJN.0000000000000435. Online ahead of print.

ABSTRACT

BACKGROUND: Long interdialytic interval in thrice-weekly hemodialysis is associated with excess cardiovascular and all-cause mortality risk. Impaired cardiorespiratory fitness is a strong predictor of mortality in hemodialysis. This study investigated differences in cardiorespiratory fitness assessed with cardiopulmonary exercise testing (CPET) between the end of the 2-day and the 3-day interdialytic interval.

METHODS: A total of 28 hemodialysis patients, randomized in two different sequences of evaluation underwent CPET and spirometry examination at the end of the 2-day and the 3-day intervals. The primary outcome was the difference in oxygen uptake at peak exercise [VO2peak(ml/kg/min)] assessed with CPET. Volume status was assessed with interdialytic-weight-gain, lung-ultrasound, bioimpedance spectroscopy (BIS), and inferior vena cava measurements. A total of 14 age- and sex-matched controls were also evaluated. Comparisons of changes in parameters of interest were performed with paired or independent t-tests, or relevant non-parametric tests, as appropriate. Bivariate correlation analyses and generalized-linear-mixed-models were employed to examine associations between changes in CPET parameters and volume indices.

RESULTS: Hemodialysis patients at the end of both 2-day and 3-day intervals presented lower values in all major CPET parameters than controls. VO2peak(ml/kg/min) was significantly higher at the end of the 2-day than the 3-day interval (15.2±4.2 vs 13.6±2.8;p<0.001); similar were the results for VO2peak(ml/min) (1188±257 vs 1074±224;p<0.001) and VO2peak(%predicted) (58.9±9.2 vs 52.3±8.6;p<0.001). Numerical but no statistically significant differences were detected in VO2-anaerobic-threshold(ml/kg/min) and VO2-anaerobic-threshold(ml/min) between the two time-points. Maximal work load (90.1±23.2 vs 79.3±25.1;p<0.001), exercise duration, heart rate at peak exercise and oxygen pulse also showed lower values at the end of the 3-day interval. Forced-expiratory-volume in 1 second levels were similar between the two evaluations. Generalized-linear-mixed-model analysis including interdialytic-weight-gain as random covariate attenuated the observed differences in VO2peak(ml/kg/min). Changes in BIS-derived overhydration indexes were moderately correlated with changes of VO2peak(ml/kg/min).

CONCLUSION: The 3-day interval was associated with further impairment of VO2 at peak exercise. This effect was predominantly driven by excess fluid accumulation during the extra interdialytic day.

PMID:38407848 | DOI:10.2215/CJN.0000000000000435

Neuroreport. 2024 Feb 19. doi: 10.1097/WNR.0000000000002011. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to comprehensively investigate the functional connectivity of key brain regions involved in motor and sensory functions, namely the precentral gyrus, postcentral gyrus and supplementary motor area (SMA). Using advanced MRI, the objective was to understand the neurophysiological integrative characterizations of these regions by examining their connectivity with eight distinct functional brain networks. The goal was to uncover their roles beyond conventional motor and sensory functions, contributing to a more holistic understanding of brain functioning.

METHODS: The study involved 198 healthy volunteers, with the primary methodology being functional connectivity analysis using advanced MRI techniques. The bilateral precentral gyrus, postcentral gyrus and SMA served as seed regions, and their connectivity with eight distinct brain regional functional networks was investigated. This approach allowed for the exploration of synchronized activity between these critical brain areas, shedding light on their integrated functioning and relationships with other brain networks.

RESULTS: The study revealed a nuanced landscape of functional connectivity for the precentral gyrus, postcentral gyrus and SMA with the main functional brain networks. Despite their high functional connectedness, these regions displayed diverse functional integrations with other networks, particularly in the salience, visual, cerebellar and language networks. Specific data and statistical significance were not provided in the abstract, but the results suggested unique and distinct roles for each brain area in sophisticated cognitive tasks beyond their conventional motor and sensory functions.

CONCLUSION: The study emphasized the multifaceted roles of the precentral gyrus, postcentral gyrus and SMA. Beyond their crucial involvement in motor and sensory functions, these regions exhibited varied functional integrations with different brain networks. The observed disparities, especially in the salience, visual, cerebellar and language networks, indicated a nuanced and specialized involvement of these regions in diverse cognitive functions. The study underscores the importance of considering the broader neurophysiological landscape to comprehend the intricate roles of these brain areas, contributing to ongoing efforts in unraveling the complexities of brain function.

PMID:38407836 | DOI:10.1097/WNR.0000000000002011

Photobiomodul Photomed Laser Surg. 2024 Feb 26. doi: 10.1089/photob.2023.0158. Online ahead of print.

ABSTRACT

Background: Burning mouth syndrome (BMS) is characterized by a burning sensation of the oral mucosa without any evidence of clinical signs or underlining condition. Several treatment modalities have been utilized with various results and levels of evidence. Lately, photobiomodulation (PBM) has emerged as a noninvasive effective therapy due to its anti-inflammatory and biostimulatory effects, especially the low-power laser setting of red wavelength. Objective: This single-blind quasi-experimental controlled clinical trial aimed to evaluate the PBM effectiveness at a low level of red laser light in patients with BMS compared with sham control. Materials and methods: Thirty patients diagnosed with BMS were consecutively assigned to intervention (PBM therapy) and control (sham) groups. The protocol for PBM dosimetry was as follows: laser 660 nm; spot size: 0.04 cm²; power output: 100 mW; emission mode: continuous wave; power density: 6 J/cm²; irradiation time: 10 sec per point within 1 cm² surface area of the symptomatic area. The treatment protocol was based on once a week for a total of 10 sessions. Results: Our results showed no statistically significant difference in reduction of pain intensity between the two groups at all the evaluated timepoints during the course of treatment. However, in both groups, we observed a statistically significant reduction of maximum pain intensity of 50% compared with patient-self reporting before the treatment. Conclusions: Further randomized clinical trials to validate our positive results with a large sample size with a long-term follow-up and understanding further the sham placebo effect are warranted.

PMID:38407832 | DOI:10.1089/photob.2023.0158

Abdom Radiol (NY). 2024 Feb 26. doi: 10.1007/s00261-024-04205-y. Online ahead of print.

ABSTRACT

OBJECTIVES: To explore the value of multi-parametric MRI (mp-MRI) radiomic model for preoperative prediction of recurrence and/or metastasis (RM) as well as survival benefits in patients with rectal cancer.

METHODS: A retrospective analysis of 234 patients from two centers with histologically confirmed rectal adenocarcinoma was conducted. All patients were divided into three groups: training, internal validation (in-vad) and external validation (ex-vad) sets. In the training set, radiomic features were extracted from T2WI, DWI, and contrast enhancement T1WI (CE-T1) sequence. Radiomic signature (RS) score was then calculated for feature screening to construct a rad-score model. Subsequently, preoperative clinical features with statistical significance were selected to construct a clinical model. Independent predictors from clinical and RS related to RM were selected to build the combined model and nomogram.

RESULTS: After feature extraction, 26 features were selected to construct the rad-score model. RS (OR = 0.007, p < 0.01), MR-detected T stage (mrT) (OR = 2.92, p = 0.03) and MR-detected circumferential resection margin (mrCRM) (OR = 4.70, p = 0.01) were identified as independent predictors of RM. Then, clinical model and combined model were constructed. ROC curve showed that the AUC, accuracy, sensitivity and specificity of the combined model were higher than that of the other two models in three sets. Kaplan-Meier curves showed that poorer disease-free survival (DFS) time was observed for patients in pT3-4 stages with low RS score (p < 0.001), similar results were also found in pCRM-positive patients (p < 0.05).

CONCLUSION: The mp-MRI radiomics model can be served as a noninvasive and accurate predictors of RM in rectal cancer that may support clinical decision-making.

PMID:38407804 | DOI:10.1007/s00261-024-04205-y

Environ Monit Assess. 2024 Feb 26;196(3):310. doi: 10.1007/s10661-024-12470-z.

ABSTRACT

To reveal differences in arsenic (As) accumulation among indica rice cultivars and assess the human health risks arising from inorganic arsenic (iAs) intake via rice consumption, a total of 320 field indica rice samples and corresponding soil samples were collected from Fujian Province in China. The results showed that available soil As (0.03 to 3.83 mg/kg) showed a statistically significant positive correlation with total soil As (0.10 to 19.45 mg/kg). The inorganic As content in brown rice was between 0.001 and 0.316 mg/kg. Among the cultivars, ten brown rice samples (3.13%) exceeded the maximum contaminant level (MCL) of iAs in food of 0.2 mg/kg in China. The estimated daily intake (EDI) and calculated individual incremental lifetime cancer risk (ILCR) ranged from 0.337 µg/day to 106.60 µg/day and from 8.18 × 10^-6 to 2.59 × 10^-3, respectively. Surprisingly, the average EDI and the EDIs of 258 (80.63%) brown rice samples were higher than the maximum daily intake (MDI) of 10 µg/day in drinking water as set by the National Research Council. The mean ILCR associated with iAs was 54.3 per 100,000, which exceeds the acceptable upper limit (AUL) of 10 per 100,000 set by the USEPA. Notably, the cultivars Y-Liang-You 1 and Shi-Ji 137 exhibited significantly higher mean ILCRs compared to the AUL and other cultivars, indicating that they pose more serious cancer risks to the local population. Finally, this study demonstrated that the cultivars Yi-Xiang 2292 and Quan-Zhen 10 were the optimal cultivars to mitigate risks associated with iAs to human health from rice consumption.

PMID:38407801 | DOI:10.1007/s10661-024-12470-z

Adv Ther. 2024 Feb 26. doi: 10.1007/s12325-024-02800-5. Online ahead of print.

ABSTRACT

INTRODUCTION: This literature review and exploratory network meta-analysis (NMA) aimed to compare the clinical effectiveness and tolerability of selective internal radiation therapy (SIRT) using yttrium-90 (Y-90) resin microspheres, regorafenib (REG), trifluridine-tipiracil (TFD/TPI), and best supportive care (BSC) in adult patients with chemotherapy-refractory or chemotherapy-intolerant metastatic colorectal cancer (mCRC).

METHODS: In light of recently published data, the literature was searched to complement and update a review published in 2018. Studies up to December 2022 comparing two or more of the treatments and reporting overall survival (OS), progression-free survival (PFS), or incidence of adverse events (AE) were included. The NMA compared hazard ratios (HRs) for OS and PFS using Markov chain Monte Carlo techniques.

RESULTS: Fifteen studies were included, with eight studies added (none addressing SIRT). All active treatments improved OS in relation to BSC. SIRT had the longest OS among all treatments, although without statistically significant differences (HR [95% credible interval] for SIRT, 0.48 [0.27, 0.87]; TFD/TPI, 0.62 [0.46, 0.83]; REG, 0.78 [0.57, 1.05]) in a fixed effects model. Information regarding SIRT was insufficient for PFS analysis, and TFD/TPI was the best intervention (HR 2.26 [1.6, 3.18]). One SIRT study reported radioembolization-induced liver disease in > 10% of the sample; this was symptomatically managed. Non-haematological AEs (hand-foot skin reaction, fatigue, diarrhoea, hypertension, rash or desquamation) were more common with REG, while haematological events (neutropoenia, leukopenia, and anaemia) were more common with TFD/TPI.

CONCLUSION: Current evidence supports SIRT treatment in patients with chemotherapy-refractory or chemotherapy-intolerant mCRC compared to newer oral agents, with comparable OS and low incidence of AEs.

PMID:38407790 | DOI:10.1007/s12325-024-02800-5

Int J Hematol. 2024 Feb 26. doi: 10.1007/s12185-024-03727-x. Online ahead of print.

ABSTRACT

The number of umbilical cord blood transplantation (U-CBT) procedures has been growing annually, but little research has been done on long-term immune recovery after U-CBT. Infection risk is high in U-CBT recipients, and this can be partially attributed to immature immunocompetent cells in umbilical cord blood. In this study, we analyzed lymphocyte subset (LST) number to determine the long-term recovery timeline. We included 36 U-CBT and 10 unrelated bone marrow transplantation (U-BMT) recipients who survived more than 2 years after transplantation, and followed them for up to 10 years post-transplant. Recovery kinetics in the early phase post-transplant was different for each LST. Recovery of CD19⁺ B cells was faster after U-CBT than after U-BMT in the first 5 years after transplantation. Although CD4⁺ T cells increased in the first several months after U-CBT, long-term cell count recovery was impaired in approximately 20% of patients. Thus, although the LST recovery pattern after U-CBT was unique, LST number recovery was statistically comparable between U-CBT and U-BMT past 5 years post-transplantation.

PMID:38407785 | DOI:10.1007/s12185-024-03727-x