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The relationship between the oxidative balance score (OBS) and the serum Klotho level has yet to be defined. We sought to investigate the potential relationship between OBS and the serum Klotho level in the U.S. population aged 40-79 years. This study included 8,145 participants from the National Health and Nutrition Examination Surveys (NHANES) database spanning from 2007 to 2016. The OBS consisted of the dietary OBS and the lifestyle OBS, based on 16 dietary components and 4 lifestyle components. Weighted multiple linear regressions were performed to explore the association between OBS and serum Klotho level. Furthermore, nonlinear relationships were analyzed through the application of restricted cubic splines (RCS). In the multivariate linear regression model with adjustment for such as demographics, economic income and dietary intake, a higher OBS was associated with a higher serum Klotho, with the beta estimate and 95%CI of 2.85 (1.03-4.68, p < 0.01). Compared with the lowest tertile group, the highest group was associated with a higher Klotho level (30.35, 3.43-57.28, p < 0.05). Furthermore, higher dietary OBS and lifestyle OBS were similarly associated with higher Klotho level (beta (95%CI): 1.27 (0.79-3.32); 14.23 (9.53-18.92), respectively). The RCS exhibited a linear dose-response association between OBS, dietary OBS and lifestyle OBS with serum Klotho concentration (P non-linearity >0.05). The association between OBS and serum Klotho level was consistent across age, sex, education, marital status, energy intake and poverty income ratio (PIR) (P interaction >0.05). The study reported significant association between OBS and klotho, indicating that adherence to antioxidant behaviors may be linked to slower aging and better health., Competing Interests: Declarations. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)

Background: Obesity and overweight, as determined by the body mass index (BMI), are harmful to metabolic health. However, the BMI can not reflect body composition or fat distribution. The fat-free mass index (FFMI) and the fat mass index (FMI) can provide more information on body composition. The aim of the observational research was to determine whether the FMI and the FFMI are significantly associated with the risk of developing diabetes and prediabetes., Methods: The investigators included data for 10,085 National Health and Nutrition Examination Survey (2011-2018) participants aged over 20 years who underwent dual-energy X-ray absorptiometry (DXA). The FFMI and the FMI were determined based on total fat mass and lean mass measured by DXA. Diabetes and prediabetes status were determined by medical history and laboratory examination. Logistic regression analyses were performed to explore the correlations between the FMI/FFMI and the risk of developing diabetes/prediabetes. Restricted cubic spline analysis was used to explore underlying nonlinear associations., Results: In the present study, 1,135 patients were diagnosed with diabetes, 3,258 had prediabetes, and 5,692 were classified as control participants. The FFMI (odds ratio (OR) = 1.10, 95% confidence interval (CI) = 1.04-1.16) and the FMI (OR = 1.08, 95% CI = 1.04-1.12) were independently related to an increased risk of developing diabetes. Moreover, the FFMI (OR 1.08, 95% CI 1.02-1.16) and the FMI (OR 1.07, 95% CI 1.02-1.13) also independently correlated with a rising risk of developing prediabetes. The restricted cubic spline (RCS) outcomes suggested that the associations are approximately linear., Conclusions: Both the FMI and the FFMI significantly correlated with the danger of developing diabetes and prediabetes, and the correlations are approximately linear., Competing Interests: Declarations The protocol for the NHANES study received approval from the Ethics Review Board of the National Center for Health Statistics. Each participant provided written informed consent prior to their involvement in the survey. As this study constitutes a secondary analysis of the publicly available NHANES database, it does not necessitate additional ethical review by the hospital’s ethics committee. Competing interests The authors declare no competing interests., (© 2024. The Author(s).)

Abstract: Background: Despite rapid advances in treatment, sepsis currently remains a major public health challenge worldwide. Over the past several years, there has been an increase in the clinical incidence of sepsis, as well as an increase in hospitalization rates, which bear the majority of the economic burden associated with sepsis. Sepsis is a public health burden due to the high fatality rates and accompanying morbidity. However, the sepsis-related mortality rates have fallen steadily over the years. One of the most common organs to fail in patients with sepsis is the kidney, and acute kidney injury (AKI) is associated with high mortality rates. This study's primary goal was to assess the impact of AKI on the evolution and outcome of hospitalization of patients with sepsis. Methods: Adults (≥18 years) hospitalized for sepsis in the United States between 2010 and 2019 were retrospectively analyzed using the nationally representative Nationwide Inpatient Sample database. Sepsis and AKI were defined using the codes of the International Classification of Diseases, Ninth Revision, Clinical Modification and the International Classification of Diseases, Tenth Revision, Clinical Modification. Results: Of the 4,258,360 outcomes, 3,946,048 met the inclusion criteria. The prevalence of AKI among sepsis inpatients increased from 39.10% in 2010 to 41% in 2019, but the impact of AKI on mortality declined over time, with in-hospital mortality from AKI among sepsis inpatients decreasing from 26.30% in 2010 to 16.30% in 2019. Hospitalizations linked to AKI were substantially more likely to involve infection sites such as the urinary tract, gastrointestinal tract, and endocarditis. Numerous pathogenic floras, including Escherichia coli , Staphylococcus aureus , Streptococcal , Enterococcus , and Pseudomonas , had greater rates among sepsis-related contacts with AKI. Furthermore, compared to hospitalization without comorbid AKI, the median total hospital charges and length of stay days for sepsis hospitalization with comorbid AKI were greater. Conclusion: With time, patients with sepsis have a higher frequency of AKI and a corresponding decline in mortality., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 by the Shock Society.)

Objective: Pimavanserin, a novel 5-HT2A receptor antagonist, has been approved for the treatment of Parkinson's disease psychosis (PDP). This study aims to conduct a comprehensive analysis of the adverse events (AEs) of pimavanserin by analyzing the FDA's Adverse Event Reporting System (FAERS) database., Methods: AE reports related to pimavanserin in the FAERS database from the second quarter of 2016 to the fourth quarter of 2023 were mined. Signal detection methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), were employed to identify and classify AEs., Results: The study collected 12,839,687 AE reports, with 30,997 reports primarily suspecting pimavanserin, identifying 166 Preferred Terms (PTs) across 27 System Organ Classes (SOCs). The data showed that males reported more frequently than females, with the highest reporting in patients aged 75 and above. Reports increased over time, with a significant rise in 2023 compared to 2016. Major categories of AEs included hallucination, death, product dose omission issue, and confusional state, with death being notably the second most reported issue. Strong and new potential AEs were identified, including sleep-related issues like somnolence, insomnia, and sleep talking; cognitive and behavioral issues such as alexithymia, belligerence, and aggression; dose-related issues like prescribed underdose and underdose; and other AEs like nonspecific reactions., Conclusion: This study reveals potential AEs of pimavanserin, including sleep disorders and cognitive changes, underscoring the importance of careful monitoring and personalized treatment in managing PDP., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2024. Published by Elsevier B.V.)

Objective: Daridorexant, a novel dual orexin receptor antagonist, was approved by the FDA in 2022 for the treatment of insomnia in adults. The aim of this study is to delve into the adverse events (AEs) of daridorexant by analyzing data from the FAERS database, to assess its safety and effectiveness in clinical applications., Methods: This study selected data from the FAERS database from the first quarter of 2022 to the third quarter of 2023. Various data analysis methods were used, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), to assess AEs related to daridorexant., Results: The study analyzed a total of 2,624,030 AE reports, of which 1318 were related to daridorexant. It identified 59 preferred terms (PTs) involving 23 system organ classes (SOCs). Signal mining identified new potential AEs related to daridorexant, including sleep-related psychiatric symptoms (nightmare, abnormal dreams, sleep terror, etc.), emotional and perceptual abnormalities (hallucination, depression, agitation), physiological and behavioral responses (palpitations, dry mouth, energy increased, etc.), suicide risk (suicidal ideation, intentional overdose), and other special concern AEs (tachyphrenia, sleep-related eating disorder, hypersensitivity)., Conclusion: Although some new potential AEs have been identified, these findings need further verification in broader datasets and long-term studies due to limitations in data sources and analysis methods. Future research should comprehensively assess the safety and effectiveness of daridorexant, providing more accurate guidance for medical professionals in the treatment of insomnia., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2024. Published by Elsevier B.V.)

Background: It remains unknown whether composite-dietary-antioxidant-index (CDAI) is associated with the risk of sarcopenia. This study investigated the association of CDAI with sarcopenia risk among general US adults., Methods: A total of 10,093 participants were enrolled in the National Health and Nutrition Examination Surveys (NHANES) from 6 survey cycles (2003-2004, 2005-2006, 2011-2012, 2013-2014, 2015-2016 and 2017-2018). Multivariate logistic regression was carried out to examine the relationship between CDAI and the risk of sarcopenia. Restricted cubic spline (RCS) curves were employed to analyze nonlinear relationships., Results: In a multi-variable logistic regression model adjusting for demographics, lifestyle, economic status and other dietary factors, higher CDAI score was related to a lower risk of sarcopenia among US adults. Compared the highest quartile of CDAI score with the lowest, the OR and 95%CI were 0.49 (0.31-0.75). Furthermore, the RCS demonstrated a linear dose-response relationship between CDAI and sarcopenia ( P non-linearity =0.92). These results remained consistent across subgroups stratified by age, sex, physical activity, drinking status, body mass index (BMI), smoking habits, energy intake, and Healthy Eating Index (HEI) score. In addition, the favorable associations of CDAI were primarily attributed to Vitamin E intake., Conclusion: A higher CDAI score was associated with a lower risk of sarcopenia. According to these results, a greater adherence to CDAI may benefit sarcopenia prevention in adults., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Wang, Zhou, Jiang, Liu and Tang.)

Objective: The underlying mechanisms of Overactive Bladder (OAB) remain unclear. This research is designed to investigate the correlation between the intake of dietary live microorganisms and OAB., Methods: This analysis encompasses a cross-sectional study of broad population information gathered from the National Health and Nutrition Examination Surveys (NHANES) spanning the years 2007 to 2018. Participants were categorized into three groups-low, medium, and high-according to their consumption of dietary live microorganisms, as per the Sanders Dietary Active Microbiota Classification System. We utilized a weighted logistic regression model, restricted cubic spline (RCS), and subgroup analyses to investigate the relationship between dietary live microorganism intake and OAB., Results: This research encompassed 16,795 subjects. The incidence of OAB was reduced in the group consuming a high amount of live dietary microbes compared to the groups with low and medium intake of such microbes. After detailed adjustments for covariates, analysis revealed that participants in the high live dietary microbe group had notably reduced odds of OAB compared to those in the low live dietary microbe group (OR: 0.84, 95% CI: 0.71-0.99, p = 0.03). RCS analysis indicated a nonlinear correlation between high dietary active microbiota intake and the incidence of OAB., Conclusion: This research emphasizes the potential advantages of a high dietary intake of active microbiota for preventing OAB. These findings support incorporating active microbiota into dietary guidelines, demonstrating their connection with a decreased incidence of OAB., (© 2024. The Author(s).)

Background: The high prevalence of diabetic kidney disease (DKD) in the United States necessitates further investigation into its impact on complications associated with total hip arthroplasty (THA). This study utilizes a large nationwide database to explore risk factors in DKD cases undergoing THA., Methods: This research utilized a case-control design, leveraging data from the national inpatient sample for the years 2016 to 2019. Employing propensity score matching (PSM), patients diagnosed with DKD were paired on a 1:1 basis with individuals free of DKD, ensuring equivalent age, sex, race, Elixhauser Comorbidity Index (ECI), and insurance coverage. Subsequently, comparisons were drawn between these PSM-matched cohorts, examining their characteristics and the incidence of post-THA complications. Multivariate logistic regression analysis was then employed to evaluate the risk of early complications after surgery., Results: DKD's prevalence in the THA cohort was 2.38%. A 7-year age gap separated DKD and non-DKD patients (74 vs. 67 years, P < 0.0001). Additionally, individuals aged above 75 exhibited a substantial 22.58% increase in DKD risk (49.16% vs. 26.58%, P < 0.0001). Notably, linear regression analysis yielded a significant association between DKD and postoperative acute kidney injury (AKI), with DKD patients demonstrating 2.274-fold greater odds of AKI in contrast with non-DKD individuals (95% CI: 2.091-2.473)., Conclusions: This study demonstrates that DKD is a significant risk factor for AKI in patients undergoing total hip arthroplasty. Optimizing preoperative kidney function through appropriate interventions might decrease the risk of poor prognosis in this population. More prospective research is warranted to investigate the potential of targeted kidney function improvement strategies in reducing AKI rates after THA. The findings of this study hold promise for enhancing preoperative counseling by surgeons, enabling them to provide DKD patients undergoing THA with more precise information regarding the risks associated with their condition., (© 2024. The Author(s).)

Aims: Studies on the association between serum lead levels and parathyroid function in adolescents are lacking. Therefore, in this study, we elucidated the possible association between blood lead levels (BLLs) and the parathyroid hormone (PTH) in adolescents aged 12-19 years in the United States., Methods: In this study, information from the database of the National Health and Nutrition Examination Survey was utilized. The study included 3919 participants from survey cycles between 2003-2004 and 2005-2006. Multivariable linear regression analysis was performed to determine the correlation between BLLs and PTH. Furthermore, smooth curve fitting was utilized to analyze the dose-response relationship between BLLs and PTH., Results: Multivariable linear regression analysis revealed that every 1 μg/dL increase in BLLs was associated with 0.67 pg/mL increase in PTH (β = 0.67, 95% CI: 0.16-1.18, p < 0.01). However, sex-stratified subgroup analysis revealed that this positive association was only observed in males (β = 1.16, 95% CI: 0.50-1.83 p < 0.01). Smooth curve fitting revealed a positive correlation between BLLs and PTH., Conclusions: In adolescents in the United States, BLLs are positively correlated with PTH, particularly in males., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 He, Wang, Luo and Zhou.)

Global investigation of medulloblastoma has been hindered by the widespread inaccessibility of molecular subgroup testing and paucity of data. To bridge this gap, we established an international molecularly characterized database encompassing 934 medulloblastoma patients from thirteen centers across China and the United States. We demonstrate how image-based machine learning strategies have the potential to create an alternative pathway for non-invasive, presurgical, and low-cost molecular subgroup prediction in the clinical management of medulloblastoma. Our robust validation strategies-including cross-validation, external validation, and consecutive validation-demonstrate the model's efficacy as a generalizable molecular diagnosis classifier. The detailed analysis of MRI characteristics replenishes the understanding of medulloblastoma through a nuanced radiographic lens. Additionally, comparisons between East Asia and North America subsets highlight critical management implications. We made this comprehensive dataset, which includes MRI signatures, clinicopathological features, treatment variables, and survival data, publicly available to advance global medulloblastoma research., Competing Interests: Declaration of interests The authors declare no competing interests., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The influence of dietary antioxidant intake on the occurrence and progression of osteoporosis may be significant. However, to date, evidence on the link between combined effect of dietary antioxidants on bone mineral density (BMD) level and risk of osteoporosis is limited. We aimed to assess the independent and combined association of dietary antioxidant intake with BMD level and risk of osteoporosis among elderly population in United States through analysis of data in the National Health and Nutrition Examination Survey., Methods: The dietary antioxidant intake was assessed based on six antioxidants, including vitamin A, vitamin C, vitamin E, zinc, selenium, and total carotenoid. A composite dietary antioxidant index (CDAI) was used to evaluate the combined exposure of dietary antioxidant intake., Results: A total of 5618 participants were included. Higher dietary vitamin A, vitamin C, vitamin E, zinc, selenium, and total carotenoid, were positively associated with BMD level. Compared with participants in the first quartile, those in the higher quartile of vitamin E (Q4: OR 0.652; 95% CI 0.463-0.918), zinc (Q4: OR 0.581; 95% CI 0.408-0.826), and selenium (Q3: OR 0.673; 95% CI 0.503-0.899) were associated with decreased risk of overall osteoporosis. Furthermore, compared to those in the first quartile, participants in the highest quartile of CDAI were associated with increased total femur (β 0.019; 95% CI 0.007-0.032), femur neck (β 0.020; 95% CI 0.009-0.032), trochanter (β 0.012; 95% CI 0.001-0.023), and intertrochanter BMD level (β 0.022; 95% CI 0.007-0.037); participants in the highest quartile of CDAI were associated with decreased risk of overall osteoporosis (OR 0.536; 95% CI 0.376-0.763). Furthermore, the associations of CDAI with the BMD level and osteoporosis risk were more significant among female participants., Conclusion: Our study provides evidence that a combination of dietary antioxidants intake was associated increased BMD level and decreased osteoporosis risk., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2023 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.)

Importance: Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials., Objective: To examine cancer clinical trial (CCT) participants' perceptions of informed consent processes and variations in perceptions by cancer type., Design and Setting and Participants: Cross-sectional survey from mixed-methods study at National Cancer Institute-designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer ( N  = 334)., Main Outcome Measures: Percentages satisfied with consent process and information provided; and assessing participation's perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type., Results: Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did-47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT., Conclusions and Relevance: Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making.

Objective: The study aimed to conduct a multidimensional evaluation of potential adverse events (AEs) of escitalopram oxalate based on the FDA adverse event reporting system (FAERS) database., Methods: This study utilized the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma-poisson shrinker (MGPS) to mine and analyze data from the FAERS database from the first quarter of 2004 to the second quarter of 2023., Results: There was a total of 19,854 AE reports related to escitalopram oxalate, extracting 625 preferred terms (PTs), and covering 27 system organ classes (SOCs). The results showed that the number of reports by females was significantly higher than males, accounting for 57.68%. The reporting number was higher in 2018 and 2019, accounting for 9.50% and 10.18% of the total reports, respectively. The main reporters were consumers and other health professionals, accounting for 26.99% and 26.75% respectively. The majority of the reports were primarily from the United States. Newly emerging AE signals such as intentional overdose ( n  = 691, ROR 8.51, PRR 8.45, IC 3.05, Empirical Bayesian Geometric Mean (EBGM) 8.35), suicide attempt ( n  = 665, ROR 8.58, PRR 8.52, IC 3.06, EBGM 8.42), serum serotonin ( n  = 5, ROR 1044.78, PRR 1044.71, IC 2.56, EBGM 392.39), anti-actin antibody positive ( n  = 5, ROR 626.87, PRR 626.83, IC 2.56, EBGM 313.91), among others, were not mentioned in the drug's label., Conclusion: While escitalopram oxalate has clear benefits in the treatment of depression and other mental health disorders, the presence of AEs also suggests risks associated with its use. Particularly concerning are risks of suicide and changes in serum serotonin levels., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: This study aims to conduct an exhaustive evaluation of Vilazodone's safety in clinical application and to unearth the potential adverse event (AE) risks associated with its utilization based on FDA Adverse Event Reporting System (FAERS) database., Methods: This research employed data spanning from the first quarter of 2011 to the third quarter of 2023 from the FAERS database. Various signal detection methodologies, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), were utilized to ascertain the correlation between Vilazodone and specific AEs., Results: The study compiled a total of 17,439,268 reports of drug AEs, out of which 5,375 were related to Vilazodone. Through signal mining, 125 Preferred Terms (PTs) encompassing 27 System Organ Classes (SOCs) were identified. The findings indicated a higher prevalence among females and patients within the 45 to 65 age bracket. The principal categories of AEs included Psychiatric disorders, Nervous system disorders, and Gastrointestinal disorders, with prevalent incidents of Diarrhoea, Nausea, and Insomnia. Moreover, the study identified robust signals of novel potential AEs, notably in areas such as sleep disturbances (Sleep paralysis, Hypnagogic hallucination, Rapid eye movements sleep abnormal, Sleep terror, Terminal insomnia, Tachyphrenia), sexual dysfunctions (Female orgasmic disorder, Orgasm abnormal, Disturbance in sexual arousal, Spontaneous penile erection, Anorgasmia, Sexual dysfunction, Ejaculation delayed), and other symptoms and injuries (Electric shock sensation, Violence-related symptom, Gun shot wound)., Conclusion: Although Vilazodone presents a positive prospect in the management of MDD, the discovery of AEs linked to its use, particularly the newly identified potential risks such as sleep and sexual dysfunctions, necessitates heightened vigilance among clinicians., (© 2024. The Author(s).)

Background: Atherogenic Index of plasma (AIP) is closely related to metabolic abnormalities. But as of now, there is no definitive conclusion on the dose-response relationship pattern between AIP and metabolic associated fatty liver disease (MAFLD)., Objective: The objective of this study was to provide a fresh insight for understanding the intrinsic link between AIP and the prevalence of MAFLD by exploring the dose-response pattern between AIP and MAFLD., Methods: A total of 9254 participants received the survey and 1090 participants were finally included according to the screening criteria. To evaluate the association between AIP and the prevalence of MAFLD based on weighted multivariate logistic regression. Sensitivity analysis of the association between AIP and MAFLD was performed using propensity score matching (PSM). Restrictive cubic splines (RCS) were used to identify patterns of dose-response relationships between AIP and MAFLD, and receiver operator characteristic (ROC) curves were used to evaluate the predictive ability of AIP and traditional lipid parameters for MAFLD., Results: In this study, a total of 563 participants were found to have MAFLD. The results of weighted multivariate logistic regression analysis demonstrated that, after adjusting for sex and age, participants in the highest quartile (Q4) of AIP had a significantly increased risk of developing MAFLD compared to those in the lowest quartile (Q1) (Model 2: OR = 9.03, 95% CI 4.75-17.17). A similar trend was observed in the fully adjusted model (Model 3: OR = 3.85, 95% CI 1.55-9.52). The RCS analysis revealed a linear dose-response association between AIP and MAFLD( P for crude non-linearity = 0.087). This association remained significant after accounting for potential confounding variables( P for adjusted non-linearity = 0.663). The ROC curve results suggest that AIP performs better than traditional lipid indicators in predicting MAFLD (AUC = 0.732, 95%CI 0.705-0.758)., Conclusion: A linear dose-response relationship exists between AIP and MAFLD, suggesting that as AIP increases, so does the risk of developing MAFLD., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Chen, Lu, Ju, Zhou and Zhao.)

Background: While increasing concerns arise about the health effects of environmental pollutants, the relationship between blood manganese (Mn) and sarcopenia has yet to be fully explored in the general population., Objective: This study aims to investigate the association between blood manganese (Mn) levels and sarcopenia in adults., Methods: In our study, we evaluated 8,135 individuals aged 18-59 years, utilizing data from the National Health and Nutrition Examination Survey (NHANES) spanning 2011 to 2018. We employed generalized additive model (GAM) to discern potential non-linear relationships and utilized the two-piecewise linear regression model to probe the association between blood Mn levels and sarcopenia., Results: After adjusting for potential confounders, we identified non-linear association between blood Mn levels and sarcopenia, with an inflection point at 13.45 μg/L. The effect sizes and the confidence intervals on the left and right sides of the inflection point were 1.006 (0.996 to 1.048) and 1.082 (1.043 to 1.122), respectively. Subgroup analysis showed that the effect sizes of blood Mn on sarcopenia have significant differences in gender and different BMI groups., Conclusion: Our results showed that a reverse U-shaped curve between blood Mn levels and sarcopenia, with an identified the inflection point at blood Mn level of 13.45 μg/L., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Xu, Chen, Zhou, Su and Zhou.)

Background: Volatile organic compounds (VOCs) encompass hundreds of high production volume chemicals and have been reported to be associated with adverse respiratory outcomes such as chronic obstructive pulmonary disease (COPD). However, research on the combined toxic effects of exposure to various VOCs on COPD is lacking. We aimed to assess the effect of VOC metabolite mixture on COPD risk in a large population sample., Methods: We assessed the effect of VOC metabolite mixture on COPD risk in 5997 adults from the National Health and Nutrition Examination Survey (NHANES) from 2011 to 2020 (pre-pandemic) using multivariate logistic regression, Bayesian weighted quantile sum regression (BWQS), quantile-based g-Computation method (Qgcomp), and Bayesian kernel machine regression (BKMR). We explored whether these associations were mediated by white blood cell (WBC) count and total bilirubin., Results: In the logistic regression model, we observed a significantly increased risk of COPD associated with 9 VOC metabolites. Conversely, N-acetyl-S-(benzyl)-L-cysteine (BMA) and N-acetyl-S-(n-propyl)-L-cysteine (BPMA) showed insignificant negative correlations with COPD risk. The overall mixture exposure demonstrated a significant positive relationship with COPD in both the BWQS model (adjusted odds ratio (OR) = 1.30, 95% confidence interval (CI): 1.06, 1.58) and BKMR model, and with marginal significance in the Qgcomp model (adjusted OR = 1.22, 95% CI: 0.98, 1.52). All three models indicated a significant effect of the VOC metabolite mixture on COPD in non-current smokers. WBC count mediated 7.1% of the VOC mixture associated-COPD in non-current smokers., Conclusions: Our findings provide novel evidence suggesting that VOCs may have adverse associations with COPD in the general population, with N, N- Dimethylformamide and 1,3-Butadiene contributing most. These findings underscore the significance of understanding the potential health risks associated with VOC mixture and emphasize the need for targeted interventions to mitigate the adverse effects on COPD risk., (© 2024. The Author(s).)

Analyze the adverse event (AE) signals of istradefylline based on the FAERS database. By extracting large-scale data from the FAERS database, this study used various signal quantification techniques such as ROR, PRR, BCPNN, and MGPS to calculate and evaluate the ratio and association between istradefylline and specific AEs. In the FAERS database, this study extracted data from the third quarter of 2019 to the first quarter of 2023, totaling 6,749,750 AE reports. After data cleansing and drug screening, a total of 3633 AE reports related to istradefylline were included for analysis. Based on four calculation methods, this study unearthed 25 System Organ Class (SOC) AE signals and 82 potential preferred terms (PTs) related to istradefylline. The analysis revealed new AEs during istradefylline treatment, including reports of Parkinsonism hyperpyrexia syndrome (n = 3, ROR 178.70, PRR 178.63, IC 1.97, EBGM 165.63), Compulsions (n = 5, ROR 130.12, PRR 130.04, IC 2.53, EBGM 123.02), Deep brain stimulation (n = 10, ROR 114.42, PRR 114.27, IC 3.33, EBGM 108.83), and Freezing phenomenon (n = 60, ROR 97.52, PRR 96.76, IC 5.21, EBGM 92.83). This study provides new risk signals and important insights into the use of istradefylline, but further research and validation are needed, especially for those AE that may occur in actual usage scenarios but are not yet explicitly described in the instructions., (© 2024. The Author(s).)

Objective: This study aims to analyze the adverse events (AEs) of Cariprazine based on the FAERS database, providing evidence for its safety surveillance., Methods: For signal quantification of Cariprazine-related AEs, we used disproportionality analysis including the Ratio of Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms., Results: We selected Cariprazine-related AE reports from the FAERS database from the fourth quarter of 2015 to the first quarter of 2023, and performed a detailed data analysis. Out of a total of 12,278,580 case reports, 3659 were found to be directly related to Cariprazine. We identified 140 Preferred Terms (PT) to describe these AEs, finding that they involved 27 organ systems. Specifically, AEs related to eye disorders such as Cataract cortical, Cataract nuclear, Accommodation disorder, Lenticular opacities, Oculogyric crisis, Dyschromatopsia were not explicitly mentioned in the drug's leaflet, indicating the presence of new ADR signals., Conclusion: Analysis of the FAERS database identified AEs associated with Cariprazine, notably in eye disorders not previously documented in the drug's official leaflet. These findings emphasize the need for continuous post-market surveillance and awareness among healthcare professionals regarding potential new ADR signals., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Purpose: This study aimed to investigate the association between macronutrient intake and biological age., Methods: Data were collected from 26,381 adults who participated in the United States National Health and Nutrition Examination Survey (NHANES). Two biological ages were estimated using the Klemera-Doubal method (KDM) and PhenoAge algorithms. Biological age acceleration (AA) was computed as the difference between biological age and chronological age. The associations between macronutrient intakes and AA were investigated., Results: After fully adjusting for confounding factors, negative associations were observed between AA and fiber intake (KDM-AA: β - 0.53, 95% CI - 0.62, - 0.43, P < 0.05; PhenoAge acceleration: β - 0.30, 95% CI - 0.35, - 0.25, P < 0.05). High-quality carbohydrate intake was associated with decreased AA (KDM-AA: β - 0.57, 95% CI - 0.67, - 0.47, P < 0.05; PhenoAge acceleration: β - 0.32, 95% CI - 0.37, - 0.26, P < 0.05), while low-quality carbohydrate was associated with increased AA (KDM-AA: β 0.30, 95% CI 0.21, 0.38, P < 0.05; PhenoAge acceleration: β 0.16, 95% CI 0.11, 0.21, P < 0.05). Plant protein was associated with decreased AA (KDM-AA: β - 0.39, 95% CI - 0.51, - 0.27, P < 0.05; PhenoAge acceleration: β - 0.21, 95% CI - 0.26, - 0.15, P < 0.05). Long-chain SFA intake increased AA (KDM-AA: β 0.16, 95% CI 0.08, 0.24, P < 0.05; PhenoAge acceleration: β 0.11, 95% CI 0.07, 0.15, P < 0.05). ω-3 PUFA was associated with decreased KDM-AA (β - 0.18, 95% CI - 0.27, - 0.08, P < 0.05) and PhenoAge acceleration (β - 0.09, 95% CI - 0.13, - 0.04, P < 0.05)., Conclusion: Our findings suggest that dietary fiber, high-quality carbohydrate, plant protein, and ω-3 PUFA intake may have a protective effect against AA, while low-quality carbohydrate and long-chain SFA intake may increase AA. Therefore, dietary interventions aimed at modifying macronutrient intakes may be useful in preventing or delaying age-related disease and improving overall health., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Objective: This study aims to analysis adverse drug events (ADE) related to Brexpiprazole from the third quarter of 2015 to the first quarter of 2023 from FAERS database., Methods: The ADE data related to Brexpiprazole from 2015 Q3 to 2023 Q1 were collected. After standardizing the data, a variety of signal quantification techniques, including ROR, PRR, BCPNN, and MGPS were used for analysis., Results: Among the 8559 ADE reports with Brexpiprazole as the primary suspected drug, 178 preferred terms (PT) of adverse reactions spanning 27 different system organ classes (SOC) were identified. Specifically, Metabolism and nutrition disorders and Reproductive system and breast disorders were unique adverse reactions to Brexpiprazole, with the latter not mentioned in the official drug label. Moreover, uncommon but significantly strong ADE signals, such as Egocentrism, Pharmacophobia, and Compulsions were observed. Notably, Tardive dyskinesia (n = 317, ROR 103.87, PRR 102.21, IC 6.21, EBGM 96.17) and Extrapyramidal disorder (n = 104, ROR 31.17, PRR 31.00, IC 4.57, EBGM 30.44) exhibited relatively high occurrence rates and signal strengths. Additionally, Lactation disorder (n = 6, ROR 48.09, PRR 48.07, IC 2.63, EBGM 46.71) and Breast discharge (n = 10, ROR 23.18, PRR 23.17, IC 2.94, EBGM 22.86) were observed, both presenting strong ADE signals., Conclusion: Brexpiprazole poses risks of various adverse reactions while providing therapeutic effects. In clinical applications, practitioners should closely monitor occurrences of Psychiatric disorders, Metabolism and nutrition disorders, Reproductive system and breast disorders, and other events., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Ectopic adrenocorticotropic hormone syndrome (EAS) is a rare condition caused by pancreatic neuroendocrine tumors (p-NETs). The severe hypercortisolemia that characterizes EAS is associated with a poor prognosis and survival. Mitotane is the only adrenolytic drug approved by the Food and Drug Administration and is often used to treat adrenocortical carcinoma. Combination therapy with mitotane and other adrenal steroidogenesis inhibitors is common for patients with Cushing's syndrome (CS). Here, we describe three patients who developed EAS secondary to the liver metastasis of p-NETs. All three rapidly developed hypercortisolemia but no typical features of CS. They underwent anti-tumor and mitotane therapy, which rapidly reduced their blood cortisol concentrations and ameliorated their symptoms. Their hypercortisolemia was controlled long term using a low dose of mitotane. The principal adverse effects were a slight loss of appetite and occasional dizziness, and there were no severe adverse effects. Importantly, even when the tumor progressed, the patients' circulating cortisol concentrations remained within the normal range. In summary, the present case series suggests that mitotane could be used to treat hypercortisolemia in patients with EAS caused by advanced p-NETs, in the absence of significant adverse effects., Competing Interests: Declaration of conflicting interestsThe authors declare that there is no conflict of interest.

Epidiolex, the first FDA-approved drug with cannabis extract, treats Dravet and Lennox-Gastaut syndromes. Using data from the FAERS database between 2018 and 2023, this study analyzed 13,275 Epidiolex-related adverse events. Through computational methods (ROR, PRR, BCPNN, EBGM), we found that real-world adverse reactions largely align with those in Epidiolex's drug leaflet. However, Seizure cluster, Blood ketone body decrease, Cortical visual impairment, Hyperactive pharyngeal reflex, and Poverty of speech emerged as potential new side effects not previously listed, warranting further attention for drug safety., Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Menu labeling regulations in the United States mandate chain restaurants to display calorie information for standard menu items, intending to facilitate healthy dietary choices and address obesity concerns. For this study, we utilized machine learning techniques to conduct a novel sentiment analysis of public opinions regarding menu labeling regulations, drawing on Twitter data from 2008 to 2022. Tweets were collected through a systematic search strategy and annotated as positive, negative, neutral, or news. Our temporal analysis revealed that tweeting peaked around major policy announcements, with a majority categorized as neutral or news-related. The prevalence of news tweets declined after 2017, as neutral views became more common over time. Deep neural network models like RoBERTa achieved strong performance (92% accuracy) in classifying sentiments. Key predictors of tweet sentiments identified by the random forest model included the author's followers and tweeting activity. Despite limitations such as Twitter's demographic biases, our analysis provides unique insights into the evolution of perceptions on the regulations since their inception, including the recent rise in negative sentiment. It underscores social media's utility for continuously monitoring public attitudes to inform health policy development, execution, and refinement.

Complex assembly tasks with multiple manual operations and steps often require rapid judgment and action under time pressure and cause most human-related errors. The task switching and action transitions are major sources of these errors. This study intends to implement an electroencephalography (EEG) approach to quantitatively evaluate the mental workload during task switching and transition. The time-frequency and spectrum analysis were utilized to compute and reflect the task demand between the intervals of individual tasks. This study developed an experiment to validate the proposed assessment approach and benchmark the results with the National Aeronautics and Space Administration task load index (NASA-TLX) subjective evaluation scale analysis. The results show that the average value of the power spectral densities (PSDs) of the gamma band signal of the AF4 channel and the beta band signal of Channel F3 show distinctive signal patterns among task stages and intervals. During the interval between the idling stage and the part selection stage, the peak of the PSD envelope increased from 18 to 27 Hz, suggesting advanced cognition increases the mental workload of the interval between different tasks. Therefore, the task switching period cannot be regarded as rest and need to be optimized with better task organization., (© 2023. Springer Nature Limited.)

Context: As a primary source of added sugars, sugar-sweetened beverage (SSB) consumption may contribute to the obesity epidemic. A soda tax is an excise tax charged on selling SSBs to reduce consumption. Currently, 8 cities/counties in the United States have imposed soda taxes., Objective: This study assessed people's sentiments toward soda taxes in the United States based on social media posts on Twitter., Design: We designed a search algorithm to systematically identify and collect soda tax-related tweets posted on Twitter. We built deep neural network models to classify tweets by sentiments., Setting: Computer modeling., Participants: Approximately 370 000 soda tax-related tweets posted on Twitter from January 1, 2015, to April 16, 2022., Main Outcome Measure: Sentiment associated with a tweet., Results: Public attention paid to soda taxes, indicated by the number of tweets posted annually, peaked in 2016, but has declined considerably ever since. The decreasing prevalence of tweets quoting soda tax-related news without revealing sentiments coincided with the rapid increase in tweets expressing a neutral sentiment toward soda taxes. The prevalence of tweets expressing a negative sentiment rose steadily from 2015 to 2019 and then slightly leveled off, whereas that of tweets expressing a positive sentiment remained unchanged. Excluding news-quoting tweets, tweets with neutral, negative, and positive sentiments occupied roughly 56%, 29%, and 15%, respectively, during 2015-2022. The authors' total number of tweets posted, followers, and retweets predicted tweet sentiment. The finalized neural network model achieved an accuracy of 88% and an F1 score of 0.87 in predicting tweet sentiments in the test set., Conclusions: Despite its potential to shape public opinion and catalyze social changes, social media remains an underutilized source of information to inform government decision making. Social media sentiment analysis may inform the design, implementation, and modification of soda tax policies to gain social support while minimizing confusion and misinterpretation., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Sintilimab combined with IBI305 treatment regimen had potential clinical benefits than sorafenib in the first-line treatment of patients with unresectable hepatic cell carcinoma (HCC). However, whether sintilimab plus IBI305 has economic benefits in China remains unclear., Methods: From the perspective of Chinese payers, we used the Markov model to simulate patients with HCC receiving treatment with sintilimab plus IBI305 and sorafenib. The transition probability between health states was estimated using the parametric survival model, and the cumulative medical costs and utility of the two treatment methods were estimated. Considering the incremental cost-effectiveness ratios (ICERs) as the evaluation index, sensitivity analyses were performed to explore the impact of uncertainty on the results., Results: Compared to sorafenib, sintilimab plus IBI305 generated an additional $17552.17 and 0.33 quality-adjusted life years, resulting in an ICER of $52817.89. The analysis outcomes were most sensitive to the total cost of sintilimab plus IBI305. With a willingness-to-pay threshold of $38,334, sintilimab plus IBI305 showed a 1.28% probability of being cost-effective. The total cost of sintilimab plus IBI305 should be reduced by at least 31.9% to be accepted by Chinese payers., Conclusions: Regardless of whether the price of sintilimab plus IBI305 and sorafenib is covered by Medicare, sintilimab plus IBI305 is unlikely to be cost-effective for first-line treatment of patients with unresectable HCC., (© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Objective: We sought to document current surgical practices among gynecologic oncologists in the United States., Methods: In March/April 2020, we conducted a cross-sectional survey among members of the Society of Gynecologic Oncology to identify gynecologic oncology practice trends in the United States. The survey collected demographic data and queried participants on types of surgical procedures performed and chemotherapy use. Univariant and multivariant analyses were used to evaluate the association between surgeon practice type, region of practice, working with gynecologic oncology fellows, time in practice, and dominant surgical modality of practice on performance of specific procedures., Results: Among 1199 gynecologic oncology surgeons who were emailed the survey, 724 completed the survey (60.4% response rate). Of these respondents, 170 (23.5%) were within 6 years of fellowship graduation, 368 (50.8%) identified as female; and 479 (66.2%) worked in an academic setting. Surgeons who worked with gynecologic oncology fellows were more likely to perform bowel surgery, upper abdominal surgery, complex upper abdominal surgery, and prescribe chemotherapy. Surgeons who were ≥ 13 years out from fellowship graduation were more likely to perform bowel surgery and complex abdominal surgery and less likely to prescribe chemotherapy and perform sentinel lymph node dissections (P < 0.05)., Conclusions: These findings highlight the variation in surgical procedures performed by gynecologic oncologists in the United States. These data support that there are practice variations that would benefit from further investigation., Competing Interests: Declaration of Competing Interest Outside the submitted work, D. Chi reports personal fees from Apyx Medical, Verthermia Inc., Biom ‘Up, and AstraZeneca, as well as recent or current stock/options ownership of Apyx Medical, Verthemia, Intuitive Surgical, Inc., TransEnterix, Inc., Doximity, Moderna, and BioNTech SE. A. Iasonos reports consulting fees from Mylan. The other authors do not have potential conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: The KEYNOTE-590 trial showed that individuals with advanced esophageal cancer who received Pembrolizumab in combination with chemotherapy as a first-line regimen achieved a significant extension of survival. However, this treatment option increases the financial burden on patients and the economic benefits remain to be further evaluated., Methods: A Markov model was used to simulate 10-year survival of patients with esophageal cancer from the perspective of United States (US) Medicare payers. We evaluated the economics of Pembrolizumab plus chemotherapy in the PD-L1 positive score (CPS ≥10) and any PD-L1 expression groups, respectively. We estimated total costs, quality-adjusted life years (QALYs), and calculated incremental cost effectiveness ratios (ICERs). Sensitivity analyses were conducted to explore the impact of uncertainties on the results. Subgroup analysis was also performed., Results: The analysis results showed that the ICER for pembrolizumab plus chemotherapy versus chemotherapy alone was $293,513.17/QALYs in the any PD-L1 expression group. This exceeded the threshold of willingness to pay ($150,000/QALYs). ICERs were most sensitive to the cost of pembrolizumab and the ICERs exceeded $150,000/QALYs in all subgroups., Conclusions: Evidence suggests that first-line pembrolizumab in combination with chemotherapy is not a cost-effective option for advanced esophageal cancer in the US, regardless of PD-L1 expression status., (© 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Cover crops are gaining traction in many agricultural regions, partly driven by increased public subsidies and by private markets for ecosystem services. These payments are motivated by environmental benefits, including improved soil health, reduced erosion, and increased soil organic carbon. However, previous work based on experimental plots or crop modeling indicates cover crops may reduce crop yields. It remains unclear, though, how recent cover crop adoption has affected productivity in commercial agricultural systems. Here we perform the first large-scale, field-level analysis of observed yield impacts from cover cropping as implemented across the US Corn Belt. We use validated satellite data products at sub-field scales to analyze maize and soybean yield outcomes for over 90,000 fields in 2019-2020. Because we lack data on cover crop species or timing, we seek to quantify the yield impacts of cover cropping as currently practiced in aggregate. Using causal forests analysis, we estimate an average maize yield loss of 5.5% on fields where cover crops were used for 3 or more years, compared with fields that did not adopt cover cropping. Maize yield losses were larger on fields with better soil ratings, cooler mid-season temperatures, and lower spring rainfall. For soybeans, average yield losses were 3.5%, with larger impacts on fields with warmer June temperatures, lower spring and late-season rainfall, and, to a lesser extent, better soils. Estimated impacts are consistent with multiple mechanisms indicated by experimental and simulation-based studies, including the effects of cover crops on nitrogen dynamics, water consumption, and soil oxygen depletion. Our results suggest a need to improve cover crop management to reduce yield penalties, and a potential need to target subsidies based on likely yield impacts. Ultimately, avoiding substantial yield penalties is important for realizing widespread adoption and associated benefits for water quality, erosion, soil carbon, and greenhouse gas emissions., (© 2022 The Authors. Global Change Biology published by John Wiley & Sons Ltd.)

Objectives: In this study, we conducted a systematic review and meta-analysis to assess whether people who achieved <7 h of sleep were more likely to develop periodontal disease (PD)., Sources: We executed electronic searches in the PubMed, EMBASE and Cochrane Library, as well as a manual search of articles published by leading journals in related fields, for observational studies, published in English from 1 January 1966 to 31 March 2021.which evaluated the relationship between sleep duration and PD. The Agency for Healthcare Research and Quality (AHRQ) quality evaluation scale was used for the cross-sectional studies, and the random effects model was used to summarize the effect sizes in the included studies with a 95% confidence interval (CI)., Results: A total of six cross-sectional studies met the inclusion criteria, totaling 107,777 participants, of which 69,773 had PD. The results of the present indicated that shorter sleep duration (<7 h) is significantly associated with PD (Odd ratio [OR], 1.19; 95% CI, 1.16-1.23; p < 0.001; I 2 , 0.0%, I 2 interval, 0%-75%). The strength of the sensitivity analysis and cumulative meta-analysis confirmed the reliability of the results., Conclusion: Although the inclusion of only six studies makes it difficult to explore whether there is a publication bias, we found that insufficient sleep duration was closely related to PD, and we therefore speculated that getting enough sleep may help prevent PD., (© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Aims: Heart failure (HF) remains a major public health problem with increasing prevalence in China. This study evaluated the clinical performance and quality measures for HF management to identify gaps in the standardization of care for patients hospitalized for HF in China., Methods and Results: Following the results of China-HF stage I (2012-2015), the second stage of the China-HF was launched in 2017. Among 113 hospitals with ≥100 cases, the China-HF Stage II assessed the quality of care measures for HF and compared results with previous data in China and the US-based Get with The Guidelines-Heart Failure (GWTG-HF) registries. In total, 34 938 patients hospitalized with HF were enrolled from January 2017 to October 2020. Echocardiographic left ventricular function and natriuretic peptide test were performed in 93.7% and 93.0% of the cases, respectively. Adherence to standardized guidelines in China-HF stage II was higher than that in the China-HF stage I, but generally lower than GWTG-HF registry with 78.2% of eligible patients was prescribed oral diuretics, 78.7% renin-angiotensin-system inhibitors, and 82.2% beta-blockers. Implantable cardioverter-defibrillators and cardiac resynchronization devices were implanted in 3.9% and 14.6%, respectively. In contrast, the proportion of eligible patients discharged with spironolactone (87.8%) was higher than GWTG-HF. The median length of hospitalization was 9 (6, 12) days, and 938 (2.8%) patients died or withdrew from treatment during hospitalization., Conclusions: Despite significant improvements in the use of guideline-recommended testing and therapy, there remain major gaps in quality of care for patients hospitalized for HF in China that are generally larger than gaps observed in the United States., (© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Adolescents from immigrant families are at risk for psychological health issues due to acculturative stress and the marked increases in internalizing and externalizing problems accompanying adolescence. Emotion Regulation (ER) may be an important protective resource for these adolescents. The present study tested the links between ER and internalizing and externalizing problems in 131 first- and second-generation Chinese American adolescents. Adolescents' reappraisal was associated with less internalizing and externalizing problems; adolescents' suppression was associated with more internalizing and externalizing problems. These links were somewhat more pronounced in adolescents high in American cultural orientation as well as in adolescents low in Chinese cultural orientation. Our results advance our understanding of the links between ER and psychological health in Chinese American youth., (© 2022 Society for Research on Adolescence.)

Importance: Attrition in cancer clinical trials (CCTs) can lead to systematic bias, underpowered analyses, and a loss of scientific knowledge to improve treatments. Little attention has focused on retention, especially the role of perceived benefits and burdens, after participants have experienced the trial., Objectives: To examine the association between patients' perceived benefits and burdens of research participation and CCT retention., Design, Setting, and Participants: This survey study was conducted at a National Cancer Institute-designated comprehensive cancer center in the Northeast region of the US. The sample included adult patients with a cancer diagnosis participating in cancer therapeutic trials. Data were collected from September 2015 to June 2019. Analysis of study data was ongoing since November 2019 through October 2022., Exposures: Self-reported validated survey instrument with a list of 22 benefits and 23 burdens of research participation that can be rated by patients with a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)., Main Outcomes and Measures: A primary outcome was actual withdrawal from the CCT, and a composite outcome was composite withdrawal that included both actual withdrawal and thoughts of withdrawing. Bivariate and multivariable logistic regressions were used., Results: Among the 334 participants in the sample, the mean (SD) age was 61.9 (11.5) years and 174 women (52.1%) were included. Top-cited benefits included both aspirational and action-oriented goals, including helping others (94.2%), contributing to society (90.3%), being treated respectfully (86.2%), and hoping for a cure (86.0%). Worry over receiving a placebo (61.3%), rearranging one's life (41.9%), and experiencing bothersome adverse effects (41.6%) were notable burdens. An increased burden score was associated with a higher probability of actual withdrawal (adjusted odds ratio [OR], 1.86; 95% CI, 1.1-3.17; P = .02) or composite withdrawal (adjusted OR, 3.44; 95% CI, 2.09-5.67; P < .001). An increased benefit score was associated with lower composite withdrawal (adjusted OR, 0.40; 95% CI, 0.24-0.66; P < .001). For participants who reported the benefits as being equal to or greater than the burdens, 13.4% withdrew. For those who perceived the benefits as being less than the burdens, 33.3% withdrew (adjusted OR, 3.38; 95% CI, 1.13-10.14; P = .03). The risk of withdrawal was even higher for the composite outcome (adjusted OR, 7.70; 95% CI, 2.76-21.48; P < .001)., Conclusions and Relevance: This survey study found that patients perceived important benefits from CCT participation, and this perception was associated with trial retention, even among those who also perceived substantial burdens. A broader dialogue among stakeholders can inform an ethical and patient-centric focus on benefits throughout the course of a CCT to increase retention.

China faces the greatest challenge from stroke in the world. According to results from the Global Burden of Disease Study 2019, there were 3.94 million new stroke cases, 28.76 million prevalent cases and 2.19 million deaths due to stroke in China in 2019. Furthermore, stroke is also the leading cause of disability-adjusted life-year (DALY) in China, the number of DALYs reached 45.9 million in 2019. Several recent large-scale epidemiological surveys have updated the data on pre-existing conditions contributed to stroke. The age-adjusted prevalence of overweight among Chinese adults aged 18-69 years was 34.4%, and the prevalence of obesity was 16.8% in 2018. 50.9% of Chinese adults ≥18 years of age without history of hypertension had prehypertension in 2018. The weighted prevalence of hypertension in adults was 27.5% in 2018. The weighted prevalence of total diabetes and pre-diabetes diagnosed by the American Diabetes Association criteria were 12.8% and 35.2%, respectively, among Chinese adults ≥18 years of age in 2017. The weighted atrial fibrillation prevalence was 1.8% among Chinese adults ≥45 years of age and equates to being present in an estimated 7.9 million people in China. Data from 1672 tertiary public hospitals in the Hospital Quality Monitoring System (HQMS) showed that 3 411 168 stroke cases were admitted during 2019. Of those, 2 818 875 (82.6%) were ischaemic strokes (ISs), 485 474 (14.2%) were intracerebral haemorrhages (ICHs), 106 819 (3.1%) were subarachnoid haemorrhages (SAHs). The average age was 66 years old, and 59.6% were male. A total of 1379 (<0.1%), 2604 (0.5%), 1250 (1.2%) paediatric strokes (age <18 years) were identified among IS, ICH and SAH, respectively. Over one-third (1 231 519 (36.1%)) of the stroke cases were covered by urban resident basic medical insurance, followed by urban employee basic medical insurance (891 103 (26.1%)) and new rural cooperative medical schema (543 108 (15.9%)). The leading risk factor was hypertension (57.3% for IS, 69.9% for ICH and 44.1% for SAH), and the leading comorbidity was pneumonia or pulmonary infection (10.4% for IS, 34.6% for ICH and 29.7% for SAH). In-hospital death/discharge against medical advice rate was 8.5%, ranging from 6.0% for IS to 20.6% for SAH. The median and IQR of length of stay was 9.0 (6.0-13.0) days, ranging from 10.0 (7.0-13.0) in IS to 14.0 (8.0-22.0) in ICH. Similar data from 2847 secondary public hospitals or private hospitals in the HQMS were also reported. Data from HQMS showed that higher proportions of interprovincial admission to other provinces were seen in Inner Mongolia, Anhui, Tibet and Beijing. Higher proportions of interprovincial admission from other provinces were seen in Beijng, Tianjin, Shanghai and Ningxia. Data from 323 601 strokes from 1337 hospitals in the Chinese Stroke Center Alliance during 2019 demonstrated that the composite scores of guideline-recommended key performance indicators for patients with IS, ICH and SAH were 0.78±0.20, 0.69±0.27 and 0.60±0.31, respectively., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Reference dose (RfD) is an estimate of a daily dose that individual can be exposed chronically without obvious deleterious effects during a lifetime. In the area of toxicology, researchers always use the traditional approach by employing NOAEL/LOAEL or the benchmark dose (BMD) and other dose-response approaches to estimate RfD. These methods have, despite their typicalness, certain limitations. In this study, we present a novel method of the estimation of reference dose without experiments. The information of the organic chemicals is available from the Integrated Risk Information System (IRIS) of USEPA. Molecular descriptors for each molecular structure were calculated by an integrated platform, and the chemicals were classified into four categories based on molecular similarity: 128 contained benzene rings, 47 were heteroaromatics, 104 contained halogen substituents and 44 were halogenated aliphatic hydrocarbons. The predictive model of RfD was constructed by the multiple linear stepwise regression (MLR) method. Approximately 95% and 82% of the data points differ by less than 10-fold and 5-fold between the predicted values and the true values respectively. The non-experimental method improves the estimation efficiency and has a certain reference value to predict., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Traditional soil vapor intrusion (VI) models usually rely on preset conceptual scenarios, simplifying the influences of limiting environmental covariates in determining indoor attenuation factors relative to subsurface sources. This study proposed a technical framework and applied it to predict VI attenuation factors based on site-specific parameters recorded in the United States Environmental Protection Agency (USEPA)'s and the California Environmental Protection Agency (CalEPA)'s VI databases, which can overcome the limitations of traditional VI models. We examined the databases with multivariate analysis of variance to identify effective covariates, which were then employed to develop VI models with three machine learning algorithms. The results of multivariate analysis show that the effective covariates include soil texture, source depth, foundation type, lateral separation, surface cover, and land use. Based on these covariates, the predicted attenuation factors by these new models are generally within one order of magnitude of the observations recorded in the databases. Then the developed models were employed to generate the generic indoor attenuation factors to subsurface vapor (i.e., the 95th percentile of selected dataset), the values of which are different between the USEPA's and CalEPA's databases by one order of magnitude, although comparable to recommendations by the USEPA and literature, respectively. Such a difference may reflect the significant regional disparity in factors such as building structures or operational conditions (e.g., indoor air exchange rates), which necessitates generating generic VI attenuation factors on a state-specific basis. This study provides an alternative for VI risk screens on a site-specific basis, especially in states with a good collection of datasets. Although the proposed technical framework is used for the VI databases, it can be equally applied to other environmental science problems., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: DNA methylation is a dynamically reversible form of epigenetics. Dynamic regulation plays an important role in cardiovascular diseases (CVDs). However, there have been few bibliometric studies in this field. We aimed to visualize the research results and hotspots of DNA methylation in CVDs using a bibliometric analysis to provide a scientific direction for future research., Methods: Publications related to DNA methylation in CVDs from January 1, 2001, to September 15, 2021, were searched and confirmed from the Web of Science Core Collection. CiteSpace 5.7 and VOSviewer 1.6.15 were used for bibliometric and knowledge-map analyses., Results: A total of 2617 publications were included in 912 academic journals by 15,584 authors from 963 institutions from 85 countries/regions. Among them, the United States of America, China, and England were the top 3 countries contributing to the field of DNA methylation. Harvard University, Columbia University, and University of Cambridge were the top 3 contributing institutions in terms of publications and were closely linked. PLoS One was the most published and co-cited journal. Baccarelli Andrea A published the most content, while Barker DJP had the highest frequency of co-citations. The keyword cluster focused on the mechanism, methyl-containing substance, exposure/risk factor, and biomarker. In terms of research hotspots, references with strong bursts, which are still ongoing, recently included "epigenetic clock" (2017-2021), "obesity, smoking, aging, and DNA methylation" (2017-2021), and "biomarker and epigenome-wide association study" (2019-2021)., Conclusions: We used bibliometric and visual methods to identify research hotspots and trends in DNA methylation in CVDs. Epigenetic clocks, biomarkers, environmental exposure, and lifestyle may become the focus and frontier of future research., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: The treatment paradigm of unresectable malignant pleural mesothelioma (MPM) has changed in recent years. Checkmate 743 demonstrate that nivolumab plus ipilimumab showed good clinical benefits compared with chemotherapy in the treatment of MPM. The study is aim to evaluate the cost-effectiveness of Nivolumab plus ipilimumab vs. platinum plus chemotherapy for the first-line treatment of unresectable MPM., Methods: A Markov model was developed to compare the cost and quality-adjusted life-year (QALY) of nivolumab plus ipilimumab and chemotherapy over a 10-year time horizon. Clinical efficacy and safety data were extracted from the CheckMate 743 trials. Health state utilities were obtained from published literature. Costs were collected from an US payer perspective. One-way and probabilistic sensitivity analyses were conducted to explore the impact of uncertainties on the cost-effectiveness's results., Results: In the base case analysis, the incremental healthcare costs and QALYs for Nivolumab plus Ipilimumab vs. chemotherapy are $196,604.22 and 0.53, respectively, resulting an incremental cost-effectiveness ratio (ICER) of $372,414.28/QALYs for the model cohort of patients with locally advanced or metastatic MPM. However, Probabilistic sensitivity analysis showed that there was no probability that Nivolumab plus ipilimumab was cost-effective within the fluctuation range of other model parameters in first-line in unresectable MPM. The results of one-way sensitivity analysis showed that the cost of Nivolumab was the most sensitive parameter., Conclusions: The ICER of Nivolumab plus ipilimumab is above the theoretical willingness-to-pay threshold in the U.S, which suggests that first-line nivolumab plus ipilimumab for unresectable MPM may be not a cost-effective choice., (Copyright © 2022 Ye, Tang, Xu, Zhou and Li.)

Background: Previous studies have revealed ethnic disparities in the prevalence of metabolic syndrome (MetS); however, the literature regarding aging-related patterns of disparities in MetS and its components remains limited., Methods: This cross-sectional study recruited 28,049 subjects, consisting of one Chinese race and three American races, 18-85 years of age, from the National Health and Nutrition Examination Survey (NHANES, 1999-2018) of the United States, and the Guangdong Gut Microbiome Project (GGMP, 2018) of China. MetS was defined in accordance with the National Cholesterol Education Program Adult Treatment Panel III. A modified sliding-window-based algorithm was used to depict the trajectories of the prevalence of MetS with increased age. Logistic regression analysis was performed to investigate associations between MetS and its components., Results: The prevalence of MetS increased non-linearly with age, with growth speed reaching its maximum at approximately 40-50 years. Chinese subjects exhibited a lower prevalence of MetS than non-Hispanic whites, non-Hispanic blacks, and Mexican Americans in all age groups. The two most prevalent components in Chinese subjects were reduced high-density lipoprotein cholesterol levels (42.0%) and elevated blood pressure (49.5%), and elevated triglyceride levels (36.3-49.5%) and abdominal obesity (55.8-55.9%) in Americans. Before 40 years of age, the top two MetS-associated components were abdominal obesity and elevated triglyceride levels in all races, while after 40 years, the prominent associations between MetS and its components varied among the different races and age groups., Conclusions: Although racial disparities in the epidemic of MetS varied with increased age, abdominal obesity and elevated triglyceride levels were the top two MetS-associated components in all younger adults of different races., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Zhang, Sun, Wang, Wang, Zhao, Yuan, Ai and Zhou.)

Because people living with HIV (PLWH) have an elevated risk for cardiovascular disease (CVD), prevention of CVD should be integrated in to HIV care. In this study, we compared the agreement between three risk scores and evaluated the indication for statin therapy based on guidelines of the American Heart Association and European AIDS Clinical Society. This study is a cross-sectional, single-center study. All PLWH ≥ 30 years without CVD and statin therapy were consecutively enrolled. Agreement between CVD risk estimates was assessed using Cohen's kappa coefficient. Of 488 PLWH, 41.2% were female with a median age of 47.8 years. D:A:D-R classified the highest proportion of patients in the categories of high/very high risk for CVD (17.8%) compared to SCORE (4.7%) and FRS (13.7%). D:A:D-R and SCORE (κ = 0.11) as well as D:A:D-R and FRS (κ = 0.33) showed poor agreement. Based on different CVD risk equations and guidelines, indication for statin therapy ranged from 34.8% to 92.0% of patients. In conclusion, a high proportion of PLWH is at high risk for CVD likely underestimated by treating physicians. Inconsistencies in the evaluation of CVD risk and primary prophylaxis should be tackled by an interdisciplinary approach.

Introduction: Mildly increased bilirubin concentration has a protective effect on oxidative stress-related diseases. However, it remains unknown whether elevated circulating bilirubin is associated with longer telomere length. The aim of this cross-sectional study was to examine the association between total bilirubin concentration and telomere length., Methods: We used the data from the National Health and Nutrition Examination Survey (NHANES) 1999-2002. The multivariable linear regression model was used to examine the association between total bilirubin concentration and telomere length. The nonlinear relationship was analyzed using a generalized additive model with the smoothing plot., Results: A total of 7818 participants with a mean age of 49.20 ± 18.82 years were included. Compared with the lowest concentration of total bilirubin (Q1), the highest quartile of total bilirubin concentration was associated with longer telomere length in male ( β = 0.04, 95 CI%: 0.00, 0.07, P = 0.024) and female ( β = 0.04, 95 CI%: 0.02, 0.04, P = 0.002). Furthermore, an inverted U-shaped relationship between total bilirubin and telomere length was found. On the left of turning points (total bilirubin < 0.5 mg/dL), total bilirubin concentration was positively associated with telomere length ( β = 0.23, 95 CI%: 0.14, 0.32, P < 0.001). However, the association between total bilirubin concentration and telomere length was not significant ( β = 0.01, 95% CI: -0.01, 0.04, P = 0.346) above the turning point., Conclusion: This is the first evidence based on a nationally representative survey demonstrating a positive and nonlinear association between total bilirubin concentration and telomere length. Future large-scale prospective studies are warranted to confirm our findings., Competing Interests: The authors declare that they have no conflict of interests., (Copyright © 2021 Lu Hao et al.)

Since the outbreak of the novel coronavirus (COVID-19) pandemic, reports of xenophobic and racist incidents directed at Chinese Americans have escalated. The present study adds further understanding to potential psychosocial effects of the COVID-19 pandemic by comparing self-reported questionnaire data from two groups of Chinese students attending a public university in western United States: the group who participated in the study before the outbreak of COVID-19 (Pre-COVID, N = 134), and the group who participated at the beginning (during-COVID, N = 64). The aim of the study was to: (a) compare mean differences in perceived discrimination and anxiety between the two groups, (b) test whether COVID-19 moderated the link between perceived discrimination and anxiety, and (c) examine whether media exposure portraying Chinese individuals negatively mediated relations between COVID-19 and discrimination. Results showed that the During-COVID group reported higher perceived discrimination and anxiety than the Pre-COVID group. The link between perceived discrimination and anxiety was stronger for the During-COVID group. Mediation analyses suggested that negative Chinese media exposure partly accounted for the group difference in perceived discrimination. Results suggest that future studies on the psychosocial implications of the COVID-19 pandemic should consider the role of discrimination in understanding the mental health of Chinese American college students., (© 2021 International Union of Psychological Science.)

The use of whole exome sequencing (WES) for the detection of disease-causing variants of genetic diseases and for non-invasive prenatal screening (NIPS) of fetal aneuploidies are two major clinical applications of next generation sequencing (NGS). This article has summarized the official documents developed and updated by the American College of Medical Genetics and Genomics (ACMG) on governing WES and NIPS. These include the development of expert consensus policies and position statements on an ongoing basis to guide clinical application of NGS technology and variant analysis, establish evidence-based practical resources, as well as standards and guidelines to govern diagnosis and screening. These ACMG documents are valuable references to Chinese geneticists, but direct adoption of these standards and guidelines may not be practical due to the differences in disease-associated variant frequencies in Chinese population, socioeconomic status, and medical practice between the two countries. It is hoped that this review could facilitate the development of NGS and NIPS standards and guidelines that are consistent with international standards and concordant with medical genetics practice in China to provide high-quality, efficient and safe clinical services for patients and their families with genetic diseases.

Immigration patterns over the last two decades have changed the demographic composition of the United States; children are growing up in an increasingly multicultural environment. Immigrant youth may face culture-related stressors and leverage culture-related strengths across development that may influence their mental and physical health. Responses to early life stressors may differ across children at the level of stress biology, which can affect how they handle cultural challenges. However, there is limited research on culture and stress biology, which may be a mediator or moderator of culture's effects on immigrant youth. The aim of the present article is to systematically review research that examines the roles of both culture and stress biology from the prenatal period to adolescence in immigrant youth. Specifically, we review articles that examine how stress-sensitive biological systems (hypothalamic pituitary adrenal axis and the autonomic nervous system) and culture-related constructs have been modeled together in immigrant youth. Based on these findings, we note remaining questions and recommendations for future research in integrating measures of cultural processes and stress biology in children., (© 2020 Wiley Periodicals LLC.)

Aims: Heart failure (HF) leads to repeat hospitalisations and reduces the duration and quality of life. Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS™ HF system was shown to be safe and reduce HF hospitalisation (HFH) rates in New York Heart Association (NYHA) class III patients. However, these findings have not been replicated in health systems outside the United States. Therefore, the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) evaluated the safety, feasibility, and performance of this device in Germany, The Netherlands, and Ireland., Methods and Results: A total of 234 NYHA class III patients (68 ± 11 years, 22% female, ≥1 HFH in the preceding year) from 31 centres were implanted with a CardioMEMS sensor and underwent PAP-guided HF management. One-year rates of freedom from device- or system-related complications and from sensor failure (co-primary outcomes) were 98.3% [95% confidence interval (CI) 95.8-100.0] and 99.6% (95% CI 97.6-100.0), respectively. Survival rate was 86.2%. For the 12 months post- vs. pre-implant, HFHs decreased by 62% (0.60 vs. 1.55 events/patient-year; hazard ratio 0.38, 95% CI 0.31-0.48; P < 0.0001). After 12 months, mean PAP decreased by 5.1 ± 7.4 mmHg, Kansas City Cardiomyopathy Questionnaire (KCCQ) overall/clinical summary scores increased from 47.0 ± 24.0/51.2 ± 24.8 to 60.5 ± 24.3/62.4 ± 24.1 (P < 0.0001), and the 9-item Patient Health Questionnaire sum score improved from 8.7 ± 5.9 to 6.3 ± 5.1 (P < 0.0001)., Conclusion: Haemodynamic-guided HF management proved feasible and safe in the health systems of Germany, The Netherlands, and Ireland. Physician-directed treatment modifications based on remotely obtained PAP values were associated with fewer HFH, sustainable PAP decreases, marked KCCQ improvements, and remission of depressive symptoms., (© 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: In this study, we compare the clinical characteristics, intraoperative management, and postoperative outcomes of patients with acute type A aortic dissection (ATAAD) between two academic medical hospitals in the United States and China., Methods: From January 2011 to December 2017, 641 and 150 patients from Nanjing Drum Tower Hospital (NDTH) and Massachusetts General Hospital (MGH) were enrolled. Patient demographics, clinical features, surgical techniques, and postoperative outcomes were compared., Results: The annual number of patients presenting with ATAAD at MGH remained relatively stable, while the number at NDTH increased significantly over the study period. The average age was 51 years at NDTH and 61 years at MGH (P < .001). The percentage of patients with known hypertension at the two centers was similar. The time interval from onset of symptoms to diagnosis was significantly longer at NDTH than MGH (11 vs 3.5 hours; P < .001). Associated complications at presentation were more common at NDTH than MGH. More than 90% of patients (91% NDTH and 92% MGH) underwent surgery. The postoperative stroke rate was higher at MGH (12% vs 4%; P < .001); however, the 30-day mortality rate was lower (7% vs 16%; P = .006)., Conclusions: There was a significant increase in the number of ATAAD at NDTH during the study period while the number at MGH remained stable. Hypertension was a common major risk factor; however, the onset of ATAAD at NDTH was nearly one decade earlier than MGH. Chinese patients tended to have more complicated preoperative pathophysiology at presentation and underwent more extensive surgical repair., (© 2020 Wiley Periodicals LLC.)

Objective: To evaluate the safety and effectiveness of a composite device design (covered stent graft and bare metal stent) for the treatment of patients with acute, complicated type B aortic dissection (TBAD) presenting with aortic rupture and/or branch vessel malperfusion., Methods: In this prospective, nonrandomized, multicenter study, 73 patients (65.8% male; mean age, 60.7 years) with acute, complicated TBAD were enrolled between August 2012 and January 2015 to receive treatment with the Zenith Dissection Endovascular System (William Cook Europe, Aps, Bjaeverskov, Denmark) at institutions in the United States and Japan. The primary safety end point was the rate of freedom from major adverse events at 30 days, and the primary effectiveness end point was the rate of survival at 30 days. This article reports primary outcomes at 30 days and follow-up results through 1 year, reflecting study data as of March 2018., Results: Of 73 patients, 20 presented with aortic rupture (27%) and 57 presented with branch vessel obstruction/compromise (78%), including 4 patients presenting with both conditions. The covered stent graft was used in all patients (median, 1; range, 1-3; 1 stent graft used in 64.4%; 47/73), and the bare metal dissection stent was used in 58 of 73 patients (79.5%). Thirty-day mortality occurred in five patients (6.8%): one procedure related, three unrelated to dissection repair, and one indeterminate. Thirty-day major adverse events included myocardial infarction (1.4%), bowel ischemia (1.4%), renal insufficiency/renal failure requiring dialysis (6.8%), stroke (6.8%), paraplegia or paraparesis (5.5%), and prolonged ventilatory support (13.7%). Nine deaths occurred from 31 to 365 days (only one death related to dissection repair); the Kaplan-Meier estimate of freedom from all-cause mortality was 80.3% ± 4.7% at 1 year. Within 365 days, 9 of 73 patients (12.3%) underwent 10 secondary interventions; no patients required conversion to open surgery. At the 12-month follow-up, complete or partial thrombosis of the false lumen was seen in 100% of patients (46/46) within the stent graft region and in 97.4% of patients (38/39) within the dissection stent region. Growth (>5 mm) of the maximum transaortic diameter was observed in 14.9% of patients (7/47) in the stent graft region and in 38.5% of patients (15/39) within the dissection stent region at 12 months., Conclusions: Thirty-day and 1-year results from the STABLE II study demonstrated favorable clinical and anatomical outcomes for the treatment of rupture and malperfusion in the setting of acute, complicated TBAD. Five-year follow-up is ongoing., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)