Tag: pubmed

JAMA Netw Open. 2024 Jul 1;7(7):e2421246. doi: 10.1001/jamanetworkopen.2024.21246.

ABSTRACT

IMPORTANCE: With the prevalence of e-cigarette use (vaping) increasing worldwide, there are concerns about children’s exposure to secondhand vapor.

OBJECTIVE: To compare nicotine absorption among children who are (1) exposed to secondhand tobacco smoke only or (2) exposed to secondhand vapor only with (3) those exposed to neither.

DESIGN, SETTING, AND PARTICIPANTS: The US Continuous National Health and Nutrition Examination Survey (NHANES) is a repeat cross-sectional survey. Participants are interviewed in their homes and, several days after, visit a mobile examination center to provide biological specimens. This study uses data from a nationally representative sample of US households from 2017 to 2020. Participants were children aged 3 to 11 years with serum cotinine levels incompatible with current firsthand nicotine use (ie, <15 μg/L). The final analysis was conducted on January 9, 2024.

EXPOSURES: Reported exposure to secondhand smoke or vapor indoors in the past 7 days (only secondhand smoke, only secondhand vapor, or neither). Covariates included age, sex, ethnicity, family income, body weight, and height.

MAIN OUTCOMES AND MEASURES: The primary outcome was serum cotinine concentration, an objective biomarker of nicotine absorption. Geometric mean cotinine levels and 95% CIs were calculated using log-normal tobit regression, accounting for the complex survey design and weights.

RESULTS: The mean (SD) age of the 1777 children surveyed was 7.4 (2.6) years, 882 (49.6%) were female, and 531 (29.9%) had family incomes below the poverty level. Nicotine absorption, as indexed by serum cotinine level, was highest among children only exposed to secondhand smoke (0.494 μg/L μg/L; 95% CI, 0.386-0.633 μg/L), followed by those exposed only to secondhand vapor (0.081 μg/L; 95% CI, 0.048-0.137 μg/L), equating to 83.6% (95% CI, 71.5%-90.5%; P < .001) lower nicotine absorption. Among children with no reported secondhand exposure, the geometric mean cotinine level was 0.016 μg/L (95% CI, 0.013-0.021 μg/L), or 96.7% (95% CI, 95.6%-97.6%; P < .001) lower than for those with exposure to secondhand smoke. Results were similar after covariate adjustment.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of US children, nicotine absorption was much lower in children who were exposed to secondhand vapor vs secondhand smoke, but higher than in those exposed to neither. These findings suggest that switching from smoking to vaping indoors may substantially reduce, but not eliminate, children’s secondhand exposure to nicotine and other noxious substances.

PMID:38990571 | DOI:10.1001/jamanetworkopen.2024.21246

JAMA Netw Open. 2024 Jul 1;7(7):e2421485. doi: 10.1001/jamanetworkopen.2024.21485.

ABSTRACT

IMPORTANCE: Patients from racial and ethnic minority groups (eg, Asian, Hispanic, and non-Hispanic Black patients) have low representation in clinical trials, especially in phase 1 trials in cancer. These trials represent valuable options for patients with advanced cancer who experience disease progression with standard therapy.

OBJECTIVE: To determine whether the benefit of enrollment to phase 1 cancer trials extends to Asian, Hispanic, and non-Hispanic Black patients as much as it does for non-Hispanic White patients.

DATA SOURCES: Patient records at a single institution from January 1999 to December 2016 were reviewed. Treatment-related responses, toxic effects, and deaths were recorded.

STUDY SELECTION: All phase 1 studies were included.

DATA EXTRACTION AND SYNTHESIS: Data underwent independent extraction by multiple observers following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.

MAIN OUTCOMES AND MEASURES: The primary outcome was overall survival (OS), assessed using univariate and multivariable time-to-event analyses.

RESULTS: A total of 738 patients (median [range], 60 [22-93] years; 467 [63.3] female) including 197 Hispanic patients (26.7%), 238 non-Hispanic Black patients (32.2%), and 282 non-Hispanic White patients (38.2%), were enrolled in 64 phase 1 trials, including 33 cytotoxic trials (51.5%), 21 biologic trials (32.8%), and 10 combined therapy trials (15.6%). The primary cancer diagnoses were colorectal (187 patients [25.3%]), ovarian (141 patients [19.1%]), lung (58 patients [7.9%]), uterine (49 patients [6.6%]), and breast (41 patients [5.6%]). Patients underwent a median (range) of 3 (0-13) therapies prior to trial enrollment. Among 558 patients evaluated for response, the clinical benefit rate (ie, stable disease plus response rates) was 49.1%, and the overall response rate was 6.5%. Grade 3 or 4 nonhematological toxic effects were observed in 27.8% (95% CI, 24.6%-31.3%) of patients and grade 3 or 4 hematological toxic effects were observed in 19.7% (95% CI, 17.0%-22.8%) of patients. The treatment-related mortality rate was 0.9% (95% CI, 0.4%-1.9%). Median OS was 9.6 (95% CI, 8.2-11.0) months among Hispanic patients, 8.3 (95% CI, 6.7-10.4) months among non-Hispanic Black patients, and 9.8 (95% CI, 8.5-11.4) months among non-Hispanic White patients (P = .13). In a multivariable analysis, age older than 60 years, Eastern Cooperative Oncology Group performance status score of 2 or greater, more than 2 metastatic sites, lactate dehydrogenase grade 1 or 2, grade 2 or greater low albumin, grade 1 or greater total bilirubin, and grade 2 or greater anemia were associated with worse prognosis, whereas leukocytosis greater than grade 1 was associated with better OS.

CONCLUSIONS AND RELEVANCE: In this meta-analysis assessing outcomes in phase 1 cancer trials among patients from racial and ethnic minority groups, Hispanic and non-Hispanic Black patients had benefits similar to those of non-Hispanic White patients.

PMID:38990570 | DOI:10.1001/jamanetworkopen.2024.21485

JAMA Otolaryngol Head Neck Surg. 2024 Jul 11. doi: 10.1001/jamaoto.2024.1854. Online ahead of print.

ABSTRACT

IMPORTANCE: Olfactory impairment (OI) and frailty are prevalent conditions associated with aging, but studies investigating their association with each other have been discordant.

OBJECTIVE: To summarize current evidence surrounding the association between OI and frailty.

DATA SOURCES: PubMed, Embase, Cochrane Library, SCOPUS, and CINAHL from inception to November 28, 2023.

STUDY SELECTION: This study included observational studies investigating the association between objectively or subjectively assessed OI and objectively evaluated frailty among adults.

DATA EXTRACTION AND SYNTHESIS: Two independent authors extracted data into a structured template. Maximally adjusted estimates were pooled using a random-effects model, and statistical heterogeneity was evaluated using I2 values. Additional prespecified subgroup and sensitivity analyses were performed. This study used the Newcastle-Ottawa Scale for bias assessment and the Grading of Recommendations Assessment, Development and Evaluation framework for overall evidence quality evaluation.

MAIN OUTCOMES AND MEASURES: The primary outcome was the cross-sectional association between OI and frailty, for which the odds of frailty were compared between participants with and without OI. The secondary outcome was the cross-sectional association between frailty and OI, for which the odds of OI were compared between participants with and without frailty.

RESULTS: This study included 10 studies with 10 624 patients (52.9% female; mean [SD] age, 62.9 [9.6] years). The Newcastle-Ottawa Scale score of studies ranged from low to moderate. Grading of Recommendations Assessment, Development and Evaluation scores ranged from low to moderate. OI was associated with a 2.32-fold (odds ratio [OR], 2.32; 95% CI, 1.63-3.31; I2 = 0%) greater odds of frailty compared with individuals with healthy olfactory function. The odds of OI was progressively greater with categorical frailty status, with a 1.55-fold (OR, 1.55; 95% CI, 1.32-1.82; I2 = 0%), 2.28-fold (OR, 2.28; 95% CI, 1.96-2.65; I2 = 0%), and 4.67-fold (OR, 4.67; 95% CI, 2.77-7.86; I2 = 0%) increase in odds for individuals with prefrailty, frailty, and the most frailty, respectively, compared with robust individuals. The results demonstrated stability in subgroup analyses (geographical continent of study, objective vs subjective olfactory assessment) and sensitivity tests.

CONCLUSIONS AND RELEVANCE: The results of this systematic review and meta-analysis suggest that there is an association between OI and frailty, with an increase in the odds of OI with worsening categorical frailty status among individuals with prefrailty, frailty, and the most frailty. OI may be a potential biomarker for frailty. Future studies could delve into whether OI may be a modifiable risk factor for frailty.

PMID:38990553 | DOI:10.1001/jamaoto.2024.1854

Death Stud. 2024 Jul 11:1-9. doi: 10.1080/07481187.2024.2376823. Online ahead of print.

ABSTRACT

This article explores the concept of posttraumatic growth (PTG) in individuals bereaved by suicide. The present study employs an exploratory approach to examine secondary data from a national survey. A sample of 2369 (n = 2369) responses were examined. Various instruments were utilized to assess grief experiences, social support, and personal growth. Descriptive statistics, correlational analysis and a hierarchical regression model were used to examine the relationship between the variables in this study. Hierarchical regression analysis revealed six independent predictors of PTG: social and formal support, time since loss, grief experiences, gender and multiple losses. The study highlighted the potential for growth in the aftermath of suicide bereavement, emphasizing the critical role of social support and the importance of time in promoting PTG. Despite some limitations, the present findings provide novel insight into the underlying mechanisms of PTG in suicide-bereaved individuals.

PMID:38990548 | DOI:10.1080/07481187.2024.2376823

Odontology. 2024 Jul 11. doi: 10.1007/s10266-024-00966-6. Online ahead of print.

ABSTRACT

The purpose of the study was to investigate the influence of different tooth-colored substrates and restoration thicknesses on the final color of gingiva-colored resin-based composites (GCRBCs). Five different shades of GCRBCs [light pink (LP), dark pink (DP), orange (Or), brown (Br), and purple (P)] were used to prepare disc-shaped specimens with 2 different thicknesses: 1.0 mm, and 2.0 mm. GCRBC discs (n = 5) were placed over 3 different tooth-colored substrates (ND1, ND5, and ND9) and color parameters were assessed using a spectroradiometer. Color differences (∆E*_ab and ∆E₀₀) were calculated using CIELab and CIEDE2000 formulas and compared to 50:50% perceptibility (PT: ∆E*_ab = 1.7, ΔE₀₀ = 1.1) and acceptability (AT: ∆E*_ab = 3.7, ΔE₀₀ = 2.8) visual thresholds. Color variation data were statistically analyzed using two-way ANOVAs followed by Bonferroni’s post hoc tests (a = 05). The ∆E*_ab and ΔE₀₀ values of GCRBCs placed over ND9 substrates were significantly higher in the LP-1.0 mm and Or-1.0 mm groups that presented values above AT (p< .001).Regardless of the substrate color and GCRBC thickness applied, ∆E*_ab and ΔE₀₀ values below AT were recorded in the gingival color groups of P. Substrate color significantly affected the color differences in the gingival color groups of LP, DP, and Or with a restoration thickness of 1.0 mm (p < .05). Gingival color, restoration thickness, and substrate color influenced the color differences of GCRBCs. When the gingival color was a lighter gingival color, rather than dark purple, the masking ability was decreased, especially with a restoration thickness of 1.0 mm.

PMID:38990497 | DOI:10.1007/s10266-024-00966-6

Esophagus. 2024 Jul 11. doi: 10.1007/s10388-024-01072-w. Online ahead of print.

ABSTRACT

BACKGROUND: S-588410, a cancer peptide vaccine (CPV), comprises five HLA-A*24:02-restricted peptides from five cancer-testis antigens. In a phase 2 study, S-588410 was well-tolerated and exhibited antitumor efficacy in patients with urothelial cancer. Therefore, we aimed to evaluate the efficacy, immune response, and safety of S-588410 in patients with completely resected esophageal squamous cell carcinoma (ESCC).

METHODS: This phase 3 study involved patients with HLA-A*24:02-positive and lymph node metastasis-positive ESCC who received neoadjuvant therapy followed by curative resection. After randomization, patients were administered S-588410 and placebo (both emulsified with Montanide™ ISA 51VG) subcutaneously. The primary endpoint was relapse-free survival (RFS). The secondary endpoints were overall survival (OS), cytotoxic T-lymphocyte (CTL) induction, and safety. Statistical significance was tested using the one-sided weighted log-rank test with the Fleming-Harrington class of weights.

RESULTS: A total of 276 patients were randomized (N = 138/group). The median RFS was 84.3 and 84.1 weeks in the S-588410 and placebo groups, respectively (P = 0.8156), whereas the median OS was 236.3 weeks and not reached, respectively (P = 0.6533). CTL induction was observed in 132/134 (98.5%) patients who received S-588410 within 12 weeks. Injection site reactions (137/140 patients [97.9%]) were the most frequent treatment-emergent adverse events in the S-588410 group. Prolonged survival was observed in S-588410-treated patients with upper thoracic ESCC, grade 3 injection-site reactions, or high CTL intensity.

CONCLUSIONS: S-588410 induced immune response and had acceptable safety but failed to reach the primary endpoint. A high CTL induction rate and intensity may be critical for prolonging survival during future CPV development.

PMID:38990441 | DOI:10.1007/s10388-024-01072-w

Adv Ther. 2024 Jul 11. doi: 10.1007/s12325-024-02921-x. Online ahead of print.

ABSTRACT

INTRODUCTION: Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) combination therapy is a standard of care for advanced non-squamous non-small cell lung cancer (NSQ-NSCLC); however, the lack of safety data limits its clinical application in Japan.

METHODS: This study compared the safety of ABCP with that of bevacizumab, carboplatin, and paclitaxel (BCP) combination for the treatment of advanced NSQ-NSCLC in Japanese patients by evaluating the clinical background and incidence of adverse events (AEs) based on data extracted from the Diagnosis Procedure Combination (DPC) database. Incidence rates and restricted mean survival times (RMSTs) for up to 1 year were analyzed for 19 clinically important AEs. Covariates were adjusted using the inverse probability weighting method.

RESULTS: A search conducted using the International Statistical Classification of Diseases and Related Health Problems 10th Revision codes identified 350,987 patients, of whom 202 were included in the ABCP cohort and 232 in the BCP cohort. Among the 19 AEs, the incidence of skin disorder and febrile neutropenia (FN) was significantly higher in the ABCP cohort versus the BCP cohort. The adjusted incidence rate ratios were 2.65 [95% confidence interval (CI) 1.43-4.91] for skin disorder and 1.70 (95% CI 1.01-2.85) for FN. The adjusted RMST differences were – 64.2 days (95% CI – 93.0 to – 35.4 days) and – 46.0 days (95% CI – 73.5 to – 18.5 days) for skin disorder and FN, respectively. These results were comparable to those of other pivotal clinical trials.

CONCLUSIONS: The findings of this DPC database study highlight the safety of ABCP in Japanese clinical practice, and this methodology may facilitate more efficient research in real-world settings.

TRIAL REGISTRATION: UMIN Clinical Trials Registry ID UMIN000041507.

PMID:38990434 | DOI:10.1007/s12325-024-02921-x

Arch Osteoporos. 2024 Jul 11;19(1):59. doi: 10.1007/s11657-024-01417-z.

ABSTRACT

The SPAH study is a population-based prospective cohort of Brazilian community-dwelling elderlies with higher fracture risk than observed in the studies used to construct the Brazilian FRAX model. In this study, the FRAX tool was a good fracture predictor within this high-risk elderly cohort, especially when calculated without bone density.

PURPOSE: To determine the performances of FRAX and age-dependent intervention thresholds according to National Osteoporosis Guideline Group (NOGG) guidelines with and without bone mineral density (BMD) regarding fracture prediction in community-dwelling elderly Brazilians.

METHODS: Seven hundred and five older adults (447 women; 258 men) were followed for 4.3 ± 0.8 years. FRAX risk for hip and major osteoporotic fractures with and without BMD was calculated at baseline. The bivariate analysis investigated the associations between the absolute probability of fracture (FRAX), as well as the age-dependent intervention thresholds (NOGG), and the incidence of vertebral fracture (VF), non-vertebral fracture (NVF), and major osteoporotic fractures (MOF), segregated by sex. Age-adjusted Poisson’s multiple regression and ROC curves were constructed to determine FRAX and NOGG’s accuracies as fracture predictors.

RESULTS: Fractures occurred in 22% of women and 15% of men. FRAX with and without BMD was higher in women with all types of fractures (p < 0.001). Only NOGG risk classification without BMD was associated with NVF (p = 0.047) and MOF (p = 0.024). FRAX was associated with NVF in the multiple regression, regardless of BMD. ROC curves of FRAX with and without BMD had AUCs of 0.74, 0.64, and 0.61 for NVF, VF, and MOF, respectively. The most accurate risk cutoffs for FRAX were 8% for MOF and 3% for hip fractures. No statistically significant associations were found in men.

CONCLUSION: FRAX predicted NVF more accurately than VF or MOF in elderlies, regardless of BMD. These results reiterate that FRAX may be used without BMD, even considering that Brazilian elderlies have known higher fracture risk.

PMID:38990403 | DOI:10.1007/s11657-024-01417-z

Mov Disord Clin Pract. 2024 Jul 11. doi: 10.1002/mdc3.14160. Online ahead of print.

ABSTRACT

BACKGROUND: Although performance rating scales, spiral drawing, water pouring, and accelerometry are commonly used to assess tremor severity, the extent to which their results correlate with impairment in activities of daily living (ADL) remains unclear.

OBJECTIVE: The aim was to identify the most effective predictors of ADL in essential tremor (ET).

METHODS: Forty ET patients were examined using The Essential Tremor Rating Assessment Scale (TETRAS), spiral drawing, volume of water spilled, and accelerometric tremor power. Root-mean-square error, R², and F-test were calculated for models predicting TETRAS ADL subscore.

RESULTS: TETRAS Performance Subscale explained the variability in TETRAS ADL with an R² value of 0.686. Models incorporating spiral rating and accelerometric tremor power (R² = 0.731) and water spillage volume (R² = 0.756) were not statistically superior.

CONCLUSIONS: TETRAS performance subscore predicted nearly 70% ADL impairment in ET patients. Incorporating the spiral rating, accelerometric tremor power, and water pouring test did not enhance ADL estimation.

PMID:38989643 | DOI:10.1002/mdc3.14160

Coron Artery Dis. 2024 Jul 8. doi: 10.1097/MCA.0000000000001402. Online ahead of print.

ABSTRACT

BACKGROUND: In myocardial infarction with nonobstructive coronary arteries (MINOCA), there are limited patient-level data on outcomes by sex and race.

OBJECTIVE: The aim of this study was to assess baseline demographics and 3-year outcomes by sex and race for MINOCA patients.

METHODS: Patients admitted to a single center with acute myocardial infarction (MI) between 1 January 2012 and 31 December 2018, were identified by chart and angiographic review. The primary outcome was nonfatal MI with secondary outcomes including nonfatal cerebrovascular accident (CVA), chest pain readmission, and repeat coronary angiography.

RESULTS: During the study period, 304 patients were admitted with MINOCA. The cohort was predominantly female (66.4%), and women were significantly older (64.6 vs. 59.2). One-sixth of the total population were Black patients, and nearly half of Black patients (47.2%) were male. Prior CVA (19.7%) and comorbid anxiety, depression, or post-traumatic stress disorder (41.1%) were common. Rates of nonfatal MI were 6.3% without difference by sex or race. For secondary outcomes, rates of CVA were 1.7%, chest pain readmission was 22.4%, and repeat angiography was 8.9%. Men were significantly more likely to have repeat angiography (13.7 vs. 6.4%), and Black patients were more likely to be readmitted for angina (34.0 vs. 19.1%). Over one-quarter of patients underwent repeat stress testing, with 8.9% ultimately undergoing repeat angiograms and low numbers (0.7%) undergoing revascularization. Men were more likely to be referred for a repeat angiogram (13.7 vs. 6.4%, P = 0.035). In multivariate analysis, Black race [odds ratio (OR), 2.31; 95% confidence interval (CI), 1.06-5.03] was associated with an increased risk of readmission for angina, while female sex was associated with decreased odds of repeat angiography (OR, 0.36; 95% CI, 0.14-0.90) and current smoking was associated with increased odds of repeat angiography (OR, 4.07; 95% CI, 1.02-16.29)] along with hyperlipidemia (OR, 4.65; 95% CI, 1.22-17.7).

CONCLUSION: White women presented more frequently with MINOCA than White men, however, Black men are equally as affected as Black women. Rates of nonfatal MI were low without statistical differences by sex or race.

PMID:38989611 | DOI:10.1097/MCA.0000000000001402