JAMA Netw Open. 2024 Jul 1;7(7):e2421202. doi: 10.1001/jamanetworkopen.2024.21202.
NO ABSTRACT
PMID:38990574 | DOI:10.1001/jamanetworkopen.2024.21202
Tag: pubmed
JAMA Netw Open. 2024 Jul 1;7(7):e2421019. doi: 10.1001/jamanetworkopen.2024.21019.
ABSTRACT
IMPORTANCE: In the US, hepatocellular carcinoma (HCC) has been the most rapidly increasing cancer since 1980, and metabolic dysfunction-associated steatotic liver disease (MASLD) is expected to soon become the leading cause of HCC.
OBJECTIVE: To develop a prediction model for HCC incidence in a cohort of patients with MASLD.
DESIGN, SETTING, AND PARTICIPANTS: This prognostic study was conducted among patients aged at least 18 years with MASLD, identified using diagnosis of MASLD using International Classification of Diseases, Ninth Revision (ICD-9) or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis codes; natural language processing of radiology imaging report text, which identified patients who had imaging evidence of MASLD but had not been formally diagnosed; or the Dallas Steatosis Index, a risk equation that identifies individuals likely to have MASLD with good precision. Patients were enrolled from Kaiser Permanente Northern California, an integrated health delivery system with more than 4.6 million members, with study entry between January 2009 and December 2018, and follow-up until HCC development, death, or study termination on September 30, 2021. Statistical analysis was performed during February 2023 and January 2024.
EXPOSURE: Data were extracted from the electronic health record and included 18 routinely measured factors associated with MASLD.
MAIN OUTCOME AND MEASURES: The cohort was split (70:30) into derivation and internal validation sets; extreme gradient boosting was used to model HCC incidence. HCC risk was divided into 3 categories, with the cumulative estimated probability of HCC 0.05% or less classified as low risk; 0.05% to 0.09%, medium risk; and 0.1% or greater, high risk.
RESULTS: A total of 1 811 461 patients (median age [IQR] at baseline, 52 [41-63] years; 982 300 [54.2%] female) participated in the study. During a median (range) follow-up of 9.3 (5.8-12.4) years, 946 patients developed HCC, for an incidence rate of 0.065 per 1000 person-years. The model achieved an area under the curve of 0.899 (95% CI, 0.882-0.916) in the validation set. At the medium-risk threshold, the model had a sensitivity of 87.5%, specificity of 81.4%, and a number needed to screen of 406. At the high-risk threshold, the model had a sensitivity of 78.4%, a specificity of 90.1%, and a number needed to screen of 241.
CONCLUSIONS AND RELEVANCE: This prognostic study of more than 1.8 million patients with MASLD used electronic health record data to develop a prediction model to discriminate between individuals with and without incident HCC with good precision. This model could serve as a starting point to identify patients with MASLD who may need intervention and/or HCC surveillance.
PMID:38990573 | DOI:10.1001/jamanetworkopen.2024.21019
JAMA Netw Open. 2024 Jul 1;7(7):e2421102. doi: 10.1001/jamanetworkopen.2024.21102.
ABSTRACT
IMPORTANCE: The Centers for Medicare & Medicaid Services Innovation Center Independence at Home (IAH) demonstration, a test of home-based primary care operating in a value-based shared-savings payment model, ended December 2023 after a decade of consistently showing savings to Medicare. It is important to assess whether high-need, IAH-qualified beneficiaries continue to pose a growing challenge to traditional Medicare (TM) or if Medicare Advantage (MA), with programmatic features favorable to caring for this subset of the general Medicare population, can disproportionately provide such care.
OBJECTIVE: To examine the size and share of IAH-qualified beneficiaries in TM and MA.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study used all Medicare claims data and MA encounter data for 2014 and 2021. IAH qualifying criteria were applied to the TM populations enrolled in Parts A and B in 2014 and 2021, and to MA enrollees in 2021. Growth in the number of IAH-qualified TM beneficiaries from 2014 to 2021 was calculated, and the proportions and numbers of IAH-qualified enrollees in the total 2021 TM and MA populations were compared. Data were analyzed between April and June 2023.
MAIN OUTCOMES AND MEASURES: The number and share of beneficiaries meeting IAH criteria in TM and MA; the share of TM spending among IAH-qualified beneficiaries.
RESULTS: Among 64 million Medicare beneficiaries in 2021, there were 30.55 million beneficiaries in TM with Parts A and B coverage, down from 33.82 million in 2014. The number of IAH-qualified beneficiaries in TM grew 51%, from 2.16 million to 3.27 million, while their proportionate share in TM grew 67% from 6.4% to 10.7% of TM between 2014 and 2021. IAH-qualified beneficiaries represented $155 billion in 2021 Medicare Parts A and B spending, 44% of all TM spending, up from 29% of total spending in 2014. In 2021, 2.15 million IAH-qualified beneficiaries represented 8.0% of Medicare Advantage enrollees. Combining TM and MA, 5.42 million IAH-qualified beneficiaries represented 9.3% of all Medicare beneficiaries, with 3.27 million (60.3%) being insured by TM.
CONCLUSIONS AND RELEVANCE: In this cohort study of IAH-qualified Medicare beneficiaries, the share of IAH-qualified beneficiaries in TM grew between 2014 and 2021, with 60% of Medicare high-need beneficiaries accounting for 44% of TM spending. The Centers for Medicare & Medicaid Services should continue to operate value-based programs like IAH that are specifically designed for these high-needs individuals.
PMID:38990572 | DOI:10.1001/jamanetworkopen.2024.21102
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