Tag: statistics

Xenotransplantation. 2024 Jan-Feb;31(1):e12844. doi: 10.1111/xen.12844.

ABSTRACT

BACKGROUND: Xenotransplantation (XTx) is an alternative treatment for organ scarcity. Investigating the acceptance of XTx among patients from diverse cultural and religious backgrounds is essential. This study aimed to evaluate the knowledge, attitudes, and awareness of XTx among patients undergoing liver transplant (LT).

METHODS: This descriptive study was conducted between November 2022 and August 2023. The study population comprised LT patients aged ≥18 years who were admitted to the hepatology clinic of a university hospital in Turkey. Of the 360 patients (n = 360) interviewed, 351 were deemed eligible for inclusion. A questionnaire was used to collect data. The Kolmogorov-Smirnov test, median, standard deviation, minimum-maximum, number, percentage, and Pearson’s chi-square test were used for statistical analysis.

RESULTS: Of the patients, 78.3% were religious and adhered to religious requirements, and 87.2% considered their religious beliefs when making important decisions. In all, 41.3% of the participants believed that organ or tissue transplantation from animals to humans is ethical, while 70.1% of the participants believed that organ and tissue transplantation from non-halal animals to humans was impossible. Specifically, 56.7% would not allow organ or tissue transplantation from a non-halal animal to themselves or a relative. Knowledge and attitude towards XTx were not affected by transplantation type (p > .05), but were affected by sex and educational level (p < .05).

CONCLUSION: This study found that LT patients generally oppose XTx. To enhance knowledge and awareness, religious leaders and healthcare professionals should organize comprehensive and effective seminars on this topic.

PMID:38407925 | DOI:10.1111/xen.12844

JAMA Netw Open. 2024 Feb 5;7(2):e2356425. doi: 10.1001/jamanetworkopen.2023.56425.

ABSTRACT

IMPORTANCE: Use of valproate and certain other antiseizure medications (ASMs) in pregnancy is associated with abnormal fetal brain development with potential long-term implications for the child.

OBJECTIVE: To examine whether use of valproate and other ASMs in pregnancy among mothers with epilepsy is associated with epilepsy risk in their children.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, population-based register cohort study included singletons born to mothers with epilepsy in Denmark, Finland, Iceland, Norway, and Sweden from January 1, 1996, to December 31, 2017. Data analysis was performed from October 2022 to December 2023.

EXPOSURE: Redeemed prescription for an ASM from 30 days before pregnancy until birth.

MAIN OUTCOMES AND MEASURES: The main outcome was epilepsy in children, assessed using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision diagnoses from hospital care. Adjusted hazard ratios (AHRs) and 95% CIs were estimated using Cox proportional hazards regression. Secondary analyses included dose-response analyses, analyses using children of mothers who discontinued ASM prior to pregnancy as the reference, and sibling analyses.

RESULTS: This cohort study included 38 663 children of mothers with epilepsy (19 854 [51.4%] boys). Children were followed up from birth; the mean length of follow-up was 7.2 years (range 0-22 years). Compared with 22 207 children of mothers not using an ASM in pregnancy, increased risks of epilepsy in children of mothers who used valproate in pregnancy (monotherapy: AHR, 2.18; 95% CI, 1.70-2.79; polytherapy: AHR, 2.10; 95% CI, 1.49-2.96) were observed. However, there was no dose-dependent association, and there was a similar risk of epilepsy in siblings who were exposed and unexposed to valproate (AHR, 0.95; 95% CI, 0.50-1.82). Prenatal exposure to topiramate monotherapy was associated with increased risk of epilepsy (AHR, 2.32; 95% CI, 1.30-4.16), and the risk was greater for higher doses, but the risk attenuated in comparisons with children of mothers who discontinued topiramate before pregnancy (AHR, 1.19; 95% CI, 0.26-5.44). Prenatal exposure to clonazepam monotherapy was also associated with increased epilepsy risk (AHR, 1.90; 95% CI, 1.16-3.12), but limited follow-up and low numbers precluded further analyses. No associations were observed for prenatal exposure to lamotrigine (AHR, 1.18; 95% CI, 0.95-1.47), levetiracetam (AHR, 1.28; 95% CI, 0.77-2.14), carbamazepine (AHR, 1.13; 95% CI, 0.85-1.50), or oxcarbazepine (AHR, 0.68; 95% CI, 0.44-1.05).

CONCLUSIONS AND RELEVANCE: In this cohort study of children born to mothers with epilepsy, the associations found between prenatal exposure to certain ASMs and the child’s risk of epilepsy did not persist in sensitivity analyses, suggesting that maternal ASM use in pregnancy may not increase epilepsy risk in children beyond that associated with the maternal epilepsy itself. These findings are reassuring for women in need of treatment with ASM in pregnancy.

PMID:38407908 | DOI:10.1001/jamanetworkopen.2023.56425

JAMA Netw Open. 2024 Feb 5;7(2):e2356466. doi: 10.1001/jamanetworkopen.2023.56466.

ABSTRACT

IMPORTANCE: Wildfires, intensified by climate change, have known effects on physical health but their effects on mental health are less well characterized. It has been hypothesized that the residential proximity to a large wildfire can exacerbate underlying mental health conditions as evidenced by increased prescriptions of psychotropic medications.

OBJECTIVE: To evaluate the association between the occurrence of large wildfires and the prescription rates of psychotropic medications immediately following the start of the fire.

DESIGN, SETTING, AND PARTICIPANTS: This cohortstudy used an interrupted time-series analysis to compare psychotropic medication prescriptions in the 6 weeks before and after each of 25 wildfires. The setting was California counties within metropolitan statistical areas (MSAs) experiencing large wildfires from 2011 through 2018. Participants included individuals residing in California MSAs with prescriptions of psychotropic medications recorded in the Merative MarketScan Research Database (MarketScan) during the study period. Statistical analysis was performed for these 25 large wildfires occurring between September 2011 and November 2018.

EXPOSURE: Residential proximity to large wildfires that burned more than 25 000 acres occurring in a California county within an MSA.

MAIN OUTCOMES AND MEASURES: Prescriptions of psychotropic medications, including antidepressants, antipsychotics, anxiolytics, hypnotics, and mood-stabilizers, with statins as a negative control outcome.

RESULTS: For the study period, prescription data and patient-level attributes were extracted for 7 115 690 unique individuals (annual mean [range]: 889 461 [455 705-1 426 928] individuals) enrolled in MarketScan and residing in fire-affected MSAs. This study found a statistically significant increase in prescriptions of antidepressants (rate ratio [RR], 1.04 [95% CI, 1.01-1.07]), anxiolytics (RR, 1.05 [95% CI, 1.02-1.09]), and mood-stabilizing medications (RR, 1.06 [95% CI, 1.01-1.13]) in the fire period compared with the prefire baseline. However, the prescriptions of antipsychotics, hypnotics, and the negative control outcome, statins, showed no significant association.

CONCLUSIONS AND RELEVANCE: In this cohort study of large California wildfires, the occurrence of wildfire was associated with increased mental health burden as reflected in increased prescription rates of certain psychotropic medications. The findings underscore the need for further scientific examination into the mental health effects of wildfires and the allocation of mental health resources in disaster responses. California experienced a substantial burden of wildfires from 2011 to 2018, and as wildfires become more intense and frequent in the context of anthropogenic climate change, it is increasingly important to understand and address their mental health effects.

PMID:38407907 | DOI:10.1001/jamanetworkopen.2023.56466

JAMA Netw Open. 2024 Feb 5;7(2):e240376. doi: 10.1001/jamanetworkopen.2024.0376.

ABSTRACT

IMPORTANCE: The use of tobacco products, including e-cigarettes and vaping, has rapidly increased among children. However, despite consistent associations found between smoking cigarettes and suicidal behaviors among adolescents and adults, there are limited data on associations between emerging tobacco products and suicidal behaviors, especially among preadolescent children.

OBJECTIVE: To examine whether the use of tobacco products is associated with nonsuicidal self-injury (NSSI), suicidal ideation (SI), and suicide attempts (SAs) among preadolescent children.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study, conducted from September 1, 2022, to September 5, 2023, included participants in the Adolescent Brain Cognitive Development study, a population-based cohort of 11 868 US children enrolled at 9 and 10 years of age. The cross-sectional investigation focused on 3-year periods starting from the baseline to year 2 of follow-up. Statistical analysis was performed from October 1, 2022, to June 30, 2023.

MAIN OUTCOMES AND MEASURES: Children’s use of tobacco products was assessed based on youth reports, including lifetime experiences of various nicotine-related products, supplemented with hair toxicologic tests. Main outcomes were children’s lifetime experiences of NSSI, SI, and SAs, assessed using the K-SADS-5 (Kiddie Schedule for Affective Disorders and Schizophrenia for the DSM-5). Multivariate logistic regression was conducted to examine the associations of the use of tobacco products with NSSI, SI, and SAs among the study participants. Sociodemographic, familial, and children’s behavioral, temperamental, and clinical outcomes were adjusted in the analyses.

RESULTS: Of 8988 unrelated study participants (median age, 9.8 years [range, 8.9-11.0 years]; 4301 girls [47.9%]), 101 children (1.1%) and 151 children (1.7%) acknowledged lifetime use of tobacco products at baseline and at 18-month follow-up, respectively. After accounting for various suicide risk factors and potential confounders, children reporting use of tobacco products were at a 3 to 5 times increased risk of SAs (baseline: n = 153 [adjusted odds ratio (OR), 4.67; 95% CI, 2.35-9.28; false discovery rate (FDR)-corrected P < .001]; year 1: n = 227 [adjusted OR, 4.25; 95% CI, 2.33-7.74; FDR-corrected P < .001]; and year 2: n = 321 [adjusted OR, 2.85; 95% CI, 1.58-5.13; FDR-corrected P = .001]). Of all facets of impulsivity measures that were significant correlates of use of tobacco products, negative urgency was the only independent risk factor for SAs (adjusted OR, 1.52 [95% CI, 1.31-1.78]; FDR-corrected P < .001). In contrast, children’s alcohol, cannabis, and prescription drug use were not associated with SAs.

CONCLUSIONS AND RELEVANCE: This study of US children suggests that the increased risk of SAs, consistently reported for adolescents and adults who smoke cigarettes, extends to a range of emerging tobacco products and manifests among elementary school-aged children. Further investigations are imperative to clarify the underlying mechanisms and to implement effective preventive policies for children.

PMID:38407905 | DOI:10.1001/jamanetworkopen.2024.0376

J Vis. 2024 Feb 1;24(2):10. doi: 10.1167/jov.24.2.10.

ABSTRACT

Growing empirical evidence shows that ensemble information (e.g., the average feature or feature variance of a set of objects) affects visual working memory for individual items. Recently, Harrison, McMaster, and Bays (2021) used a change detection task to test whether observers explicitly rely on ensemble representations to improve their memory for individual objects. They found that sensitivity to simultaneous changes in all memorized items (which also globally changed set summary statistics) rarely exceeded a level predicted by the so-called optimal summation model within the signal-detection framework. This model implies simple integration of evidence for change from all individual items and no additional evidence coming from ensemble. Here, we argue that performance at the level of optimal summation does not rule out the use of ensemble information. First, in two experiments, we show that, even if evidence from only one item is available at test, the statistics of the whole memory set affect performance. Second, we argue that optimal summation itself can be conceptually interpreted as one of the strategies of holistic, ensemble-based decision. We also redefine the reference level for the item-based strategy as the so-called “minimum rule,” which predicts performance far below the optimum. We found that that both our and Harrison et al. (2021)’s observers consistently outperformed this level. We conclude that observers can rely on ensemble information when performing visual change detection. Overall, our work clarifies and refines the use of signal-detection analysis in measuring and modeling working memory.

PMID:38407901 | DOI:10.1167/jov.24.2.10

Lymphat Res Biol. 2024 Feb 26. doi: 10.1089/lrb.2023.0065. Online ahead of print.

ABSTRACT

Background: Lipedema is a progressive condition involving excessive deposition of subcutaneous adipose tissue, predominantly in the lower limbs, which severely compromises quality of life. Despite the impact of lipedema, its molecular and genetic bases are poorly understood, making diagnosis and treatment difficult. Historical evaluation of individuals with lipedema indicates a positive family history in 60%-80% of cases; however, genetic investigation of larger family cohorts is required. Here, we report the largest family-based sequencing study to date, aimed at identifying genetic changes that contribute to lipedema. Methods and Results: DNA samples from 31 individuals from 9 lipedema families were analyzed to reveal genetic variants predicted to alter protein function, yielding candidate variants in 469 genes. We did not identify any individual genes that contained likely disease-causing variants across all participating families. However, gene ontology analysis highlighted vasopressin receptor activity, microfibril binding, and patched binding as statistically significantly overrepresented categories for the set of candidate variants. Conclusions: Our study suggests that lipedema is not caused by a single exomic genetic factor, providing support for the hypothesis of genetic heterogeneity in the etiology of lipedema. As the largest study of its kind in the lipedema field, the results advance our understanding of the disease and provide a roadmap for future research aimed at improving the lives of those affected by lipedema.

PMID:38407896 | DOI:10.1089/lrb.2023.0065

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