Categories
Nevin Manimala Statistics

Neighborhood Vulnerability and Age of Natural Menopause and Menopausal Symptoms Among Midlife Women

JAMA Netw Open. 2025 May 1;8(5):e2512075. doi: 10.1001/jamanetworkopen.2025.12075.

ABSTRACT

IMPORTANCE: Women experiencing more severe menopausal symptoms exhibit poorer quality of life, and those with early menopause have a higher risk of developing chronic diseases. However, the extent to which neighborhood disadvantage contributes to menopause onset and symptom severity remains understudied.

OBJECTIVE: To examine the association of Social Vulnerability Index (SVI) with age of natural menopause onset and menopausal symptom severity.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from a prospective cohort of women participating in Project Viva who were initially enrolled in eastern Massachusetts and followed up from pregnancy to midlife between April 1999 and August 2021. Participant inclusion required geocoded residential addresses at enrollment (1999-2002), 8-year follow-up (2006-2010), and 13-year follow-up (2012-2016); age at natural menopause; and menopausal symptoms. Data were analyzed between March 1 and June 30, 2024.

EXPOSURES: SVI grouped into 5 categories: very low (<20th percentile), low (20th to <40th percentile), moderate (40th to <60th percentile), high (60th to <80th percentile), or very high (≥80th percentile) vulnerability.

MAIN OUTCOMES AND MEASURES: Age at natural menopause and self-reported menopausal symptoms based on the presence and severity of 11 symptoms over the past year. These symptoms were assessed using the Menopause Rating Scale (total score range: 0-44, with higher scores indicating greater severity).

RESULTS: Of the 691 women included in the study (mean [SD] enrollment age, 33.7 [3.8] years; 41 with Asian [6.0%], 79 with Black [11.5%], 39 with Hispanic [5.7%], 507 with White [73.6%], and 23 with other [3.3%] race and ethnicity), 87 (12.6%) resided in neighborhoods with very high SVI at enrollment, 38 of 635 (6.0%) at 8-year follow-up, and 41 of 660 (6.2%) at 13-year follow-up. The Kaplan-Meier estimate for median age of natural menopause was earlier in women residing in neighborhoods with very high vs very low SVI at enrollment (52.0 [95% CI, 51.0-53.0] years vs 53.0 [95% CI, 53.0-54.0] years), 8-year follow-up (51.0 [95% CI, 50.0-53.0] years vs 53.0 [95% CI, 53.0-54.0] years), and 13-year follow-up (51.0 [95% CI, 50.0-53.0] years vs 53.0 [95% CI, 53.0-54.0] years). After adjusting for covariates, residence in neighborhoods with very high (but not low, moderate, or high) vs very low SVI at enrollment (adjusted hazard ratio [AHR], 1.36; 95% CI, 0.90-2.06), 8-year follow-up (AHR, 2.23 (95% CI, 1.29-3.85), and 13-year follow-up (AHR, 2.18 (95% CI, 1.30-3.66) was associated with higher risk of earlier natural menopause. SVI was not associated with menopausal symptoms.

CONCLUSIONS AND RELEVANCE: In this cohort study, women who resided in neighborhoods with very high vulnerability within 10 years of the perimenopause period exhibited higher risk of earlier natural menopause. Future research is warranted to explore whether initiatives to improve neighborhood conditions could mitigate the association of neighborhood disadvantage with earlier menopause onset.

PMID:40402495 | DOI:10.1001/jamanetworkopen.2025.12075

Categories
Nevin Manimala Statistics

Participant Needs, Service Utilization, and Costs in a Medicaid Housing Pilot Program

JAMA Netw Open. 2025 May 1;8(5):e2512405. doi: 10.1001/jamanetworkopen.2025.12405.

ABSTRACT

IMPORTANCE: Housing instability and homelessness have wide-ranging health and social effects. Health systems increasingly recognize the importance of addressing these needs to make progress toward health equity goals and reduce health care costs. State Medicaid programs are uniquely positioned to support the housing needs of their members but are relatively new to the housing space and need to understand how to most effectively partner with the housing sector to improve health outcomes.

OBJECTIVE: To evaluate the implementation and initial outcomes of a housing benefit pilot program, including participant characteristics, needs, and service utilization.

DESIGN, SETTING, AND PARTICIPANTS: This was a cohort study involving a pilot program that provided temporary rental assistance, housing navigation, and additional supports to Medicaid members between May 2022 and October 2024. The pilot took place in the Portland, Oregon, metropolitan area involving Medicaid members of Health Share of Oregon, a large coordinated care organization. Individuals were referred to the program primarily from foster care, substance use disorder residential programs, and corrections facilities. Data were analyzed from October 2024 to March 2025.

EXPOSURE: Enrolled participants received services, including temporary rental assistance, housing navigation, and other supports, for up to 12 months, with modifications made mid-pilot due to capacity challenges.

MAIN OUTCOMES AND MEASURES: Participant demographic characteristics, baseline needs, service utilization, and costs associated with the housing benefit program.

RESULTS: Of 716 referrals, 517 individuals (mean [SD] age, 37.8 [11.1] years; 295 [57.1%] male) enrolled; including 14 American Indian or Alaskan Native individuals (2.7%), 7 Asian individuals (1.4%), 67 Black individuals (13.0%), 22 Hispanic individuals (4.3%), 6 Native Hawaiian or Pacific Islander individuals (1.2%), and 308 White individuals (59.6%); 513 individuals (99.2%) spoke English. Participants had substantial housing needs, with rent (383 individuals [74.1%]) and utility (282 individuals [54.5%]) support being the most frequently reported needs and used services. The mean (SD) cost per member per month was $2225 ($1586). Frequently reported nonhousing needs included employment (154 individuals [42.3%]), food (152 individuals [41.8%]), mental health (94 individuals [25.8%]), and transportation (86 individuals [23.6%]).

CONCLUSIONS AND RELEVANCE: The findings of this cohort study provide critical insights into the types of services needed and associated costs for supporting housing as a Medicaid benefit. Significant needs were observed, emphasizing the necessity of cross-sector collaboration and clear role definitions between health care and housing organizations. The findings offer valuable lessons for the design and implementation of housing support programs under Medicaid; these insights are crucial as Oregon and other states consider similar initiatives to address housing as a health-related social need.

PMID:40402494 | DOI:10.1001/jamanetworkopen.2025.12405

Categories
Nevin Manimala Statistics

ctDNA and Recurrence Risk for Adjuvant De-Escalation in HPV-Positive Oropharyngeal Carcinoma: A Secondary Analysis of the DART Phase 3 Randomized Clinical Trial

JAMA Otolaryngol Head Neck Surg. 2025 May 22. doi: 10.1001/jamaoto.2025.0903. Online ahead of print.

ABSTRACT

IMPORTANCE: The De-escalated Adjuvant Radiation Therapy (DART) phase 3 randomized clinical trial (RCT) showed that in patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma, postoperative minimal residual disease (MRD), detected through circulating tumor HPV DNA (ctHPVDNA), was associated with a higher risk of disease progression. When considered along with pathologic factors, postoperative ctHPVDNA assessment may improve patient selection for adjuvant treatment de-escalation; however, more data are needed to demonstrate how it may be used in personalizing treatment intensity.

OBJECTIVE: To determine the association of postoperative MRD status with progression-free survival (PFS) after surgery for HPV-associated oropharyngeal squamous cell carcinoma.

DESIGN, SETTING, AND PARTICIPANTS: This was a secondary analysis of the DART RCT, which was conducted from October 2016 to August 2020 in multiple sites in the US. Participants from the de-escalated adjuvant radiation therapy group and the standard of care group with available blood specimen data were included. Reports from 3-month posttreatment surveillance visits were used to assess associations and outcomes. Data analyses were performed from March 2023 to March of 2025.

INTERVENTIONS: The DART group received 30 to 36 Gy of radiation therapy in 1.5 to 1.8 Gy twice daily, plus docetaxel, 15 mg/m2, on days 1 and 8. The standard of care group received 60 Gy with or without weekly cisplatin, 40 mg/m2.

MAIN OUTCOME AND MEASURE: PFS.

RESULTS: The analysis included 140 patients (mean [SD] age, 59.1 [8.4] years; 12 [8.6%] females and 128 [91.4%] males; 97 [69.3%] with no smoking history); characteristics were similar to the overall DART RCT population. Of these, 17 patients (12.1%) had postoperative MRD (13 of 96 [13.5%] receiving DART and 4 of 44 [9.1%] receiving standard of care). For all patients, postoperative MRD positivity was strongly associated with worsened PFS at 24 months (MRD positivity, 69.5%; MRD negativity, 95.9%; hazard ratio [HR], 0.19; 95% CI, 0.06-0.59). MRD positivity was associated with PFS when evaluating only those patients in the DART group, where 24-month PFS was 68.4% compared to 92.6% for MRD-negative patients (HR, 0.28; 95% CI, 0.08-0.93). Three months after completion of all treatment, 8 of 117 patients (6.8%) had detectable ctHPVDNA, whereas 109 of 117 (93.2%) did not, and detection was highly associated with PFS (HR, 20.48; 95% CI, 6.91-60.67).

CONCLUSIONS AND RELEVANCE: This secondary analysis of the DART RCT found that patients with detectable ctHPVDNA after surgery had a higher risk of disease progression. When added to the pathologic factors considered, ctHPVDNA assessment may improve selection of patients for treatment de-escalation. In addition, the 3-month posttreatment time point, early in surveillance, may identify a sizable portion of patients with progression and may guide intervention and surveillance after surgery for HPV-associated oropharyngeal squamous cell carcinoma.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02908477.

PMID:40402484 | DOI:10.1001/jamaoto.2025.0903

Categories
Nevin Manimala Statistics

Hemp-derived tetrahydrocannabinol (THC) and kratom related health claims provided by smoke shop employees: a secret shopper study

Am J Drug Alcohol Abuse. 2025 May 22:1-9. doi: 10.1080/00952990.2025.2502743. Online ahead of print.

ABSTRACT

Background: US smoke shop prevalence is growing and stores are diversifying products beyond nicotine vape supplies, often selling non-regulated psychoactive substances.Objectives: Investigate health claims and safety information provided by smoke shop employees regarding hemp-derived tetrahydrocannabinol (THC) and kratom.Methods: Secret shopper visits were conducted at 100 San Antonio and Austin, Texas smoke shops. Using scripted questions, shoppers assessed whether the shop sold THC and kratom, what these products could be used for, and adverse effects. Shoppers documented product availability, disease states referenced, health claims made, adverse effects mentioned, and guidance for use related to pregnancy. Descriptive statistics were calculated to characterize shopper reports.Results: THC (100%) and kratom (94%) were routinely stocked by smoke shops. Most employees made at least one health claim regarding THC (50%) or kratom (81%). Claims regarding pain (50%), insomnia (31%), and mental health disorders (27%) were most commonly discussed for THC, while drug withdrawal/cravings (76%), pain (69%), and mental health conditions (31%) were most frequent for kratom. When specifically asked about adverse effects, 22% and 24% of smoke shop employees, respectively, did not disclose any risks about THC or kratom; most others provided minimal information. The most common risks discussed were sedation (36%) and psychiatric (31%) adverse effects for THC, and dependence (59%) and gastrointestinal (24%) adverse effects for kratom.Conclusion: Efforts to develop evidence-based consumer information regarding kratom and hemp-derived THC, improve health information provided by smoke shop employees, and incentivize store owners to devote resources to employee education are needed.

PMID:40402475 | DOI:10.1080/00952990.2025.2502743

Categories
Nevin Manimala Statistics

Four-Year Experience of HIV Pre-exposure Prophylaxis (PrEP) from an Italian Multicentre Cohort: Incidence of Sexually Transmitted Infections and Renal Toxicity

AIDS Behav. 2025 May 22. doi: 10.1007/s10461-025-04736-5. Online ahead of print.

ABSTRACT

Pre-Exposure Prophylaxis (PrEP) with Tenofovir-Disoproxil/Emtricitabine (TDF/FTC) is efficacious for HIV prevention. PrEP users might be more exposed to other sexually transmitted infections (STIs) and toxicities. Our aim was to evaluate the trend of STIs and toxicities in an Italian PrEP cohort. A retrospective multicentre cohort study (Modena, Genova and Padova) including TDF/FTC-PrEP users followed from Jan-2019 to Jul-2022. Data collection included demographics, toxicities and STIs detection: N.gonorrhoeae (NG), C.trachomatis (CT), M.genitalium (MG), T.vaginalis (TV), T.pallidum (TP), HAV, HBV and HCV. Two-hundred-forty-four persons included: 97% males; median age 39 years (IQR 33-47). A nearly incremental trend was recorded in NG and MG incidences, especially after 2020: from 5.7% to 2.3% in 2020, to 10.3% and 6.5% in 2021 and to 9.6% and 4.8% in the first 7 months of 2022. CT and TP presented a variable trend, while only two TV diagnoses were done. The test for trend for ordered groups across years showed no statistical significance for all the STIs and the annual proportions of subjects with multiple STIs varied. At logistic regression, only history of STIs was associated to risk of new STIs. Twenty cases of nephrotoxicity were recorded, leading to PrEP interruption in 1 case only. Concluding, STIs incidence and nephrotoxicity in our cohort were consistent with other data from literature. In 2020 we observed a lower STIs incidence, probably as consequence of COVID-19 restrictions. An incremental trend could be hypothesized regarding NG, MG and CT incidence. Thus, we suggest STIs monitoring, prophylaxis and treatment to contain their spread among PrEP users.

PMID:40402466 | DOI:10.1007/s10461-025-04736-5

Categories
Nevin Manimala Statistics

A patented portable multifunctional nebulizer for enhanced respiratory drug delivery: an experimental study

Drug Deliv Transl Res. 2025 May 22. doi: 10.1007/s13346-025-01882-0. Online ahead of print.

ABSTRACT

This study aimed to design and evaluate the clinical efficacy of a new patented portable multifunctional medical nebulizer. The portable multifunctional nebulizer, constructed using medical-grade PVC, incorporates four main systems: a nebulization system, a particle size adjustment mechanism, a heating unit, and a power storage system. This study employed a comparative experimental design. A conventional medical nebulizer, commonly used in a tertiary hospital, was selected as the control group, while the newly developed portable multifunctional nebulizer served as the experimental group. Each group underwent 30 experimental runs, with controlled variables across all tests. Key parameters assessed included initial mist emission time, nebulization rate, particle size distribution, medication splash loss, residual drug volume, and noise levels. The particle size distribution was measured using dynamic light scattering (DLS) technology, while medication loss was calculated by capturing mist spillover and measuring residual drug volume. Noise levels during stable nebulization were recorded using a sound level meter. The experimental group demonstrated the production of smaller, more uniform nebulized particles, reduced medication splash loss, decreased residual drug volume, and lower noise emissions. Statistically significant differences (P < 0.05) were observed across all parameters when compared to the control group. The multifunctional medical nebulizer consistently generates particles within a size range of 120-160 nm, improving drug delivery to target organs, minimizing medication loss, and reducing operational noise. This innovative design represents a significant advancement in the clinical application of respiratory therapy.

PMID:40402464 | DOI:10.1007/s13346-025-01882-0

Categories
Nevin Manimala Statistics

Virtual biopsy through CT imaging: can radiomics differentiate between subtypes of non-small cell lung cancer?

Radiol Med. 2025 May 22. doi: 10.1007/s11547-025-02022-x. Online ahead of print.

ABSTRACT

OBJECTIVE: This study evaluated the performance of CT radiomics in distinguishing between lung adenocarcinoma (ADC) and squamous cell carcinoma (SCC) at baseline imaging, exploring its potential as a noninvasive virtual biopsy.

MATERIALS AND METHODS: A retrospective analysis was conducted, enrolling 330 patients between September 2015 and January 2023. Inclusion criteria were histologically proven ADC or SCC and baseline contrast-enhanced chest CT. Exclusion criteria included significant motion artifacts and nodules < 6 mm. Radiological features, including lung lobe affected, peripheral/central location, presence of emphysema, and T/N radiological stage, were assessed for each patient. Volumetric segmentation of lung cancers was performed on baseline CT scans at the portal-venous phase using 3DSlicer software (v5.2.2). A total of 107 radiomic features were extracted and selected using the least absolute shrinkage and selection operator (LASSO) and tenfold cross-validation. Multivariable logistic regression analysis was employed to develop three predictive models: radiological features-only, radiomics-only, and a combined model, with statistical significance set at p < 0.05. Additionally, an independent external validation cohort of 16 patients, meeting the same inclusion and exclusion criteria, was identified.

RESULTS: The final cohort comprised 200 ADC and 100 SCC patients (mean age 68 ± 10 years, 184 men). Two radiological and 21 radiomic features were selected (p < 0.001). The Radiological model achieved AUC 0.73 (95% CI 0.68-0.78, p < 0.001), 72.3% accuracy. The radiomics model achieved AUC 0.80 (95% CI 0.75-0.85, p < 0.001), 75.6% accuracy. The combined model achieved AUC 0.84 (95% CI 0.80-0.88, p < 0.001), 75.3% accuracy. External validation (n = 15) yielded AUC 0.78 (p = 0.05).

CONCLUSION: The combined radiologic-radiomics model showed the best performance in differentiating ADC from SCC.

PMID:40402434 | DOI:10.1007/s11547-025-02022-x

Categories
Nevin Manimala Statistics

Accuracy of point-of-care-ultrasound performed by physicians in the diagnosis of deep vein thrombosis

Vascular. 2025 May 22:17085381251342387. doi: 10.1177/17085381251342387. Online ahead of print.

ABSTRACT

BackgroundThe diagnosis of deep vein thrombosis (DVT) is usually made by a sonographer using a thorough Doppler ultrasound. The current study examined whether emergency resident physicians could accurately diagnose DVT using a point-of-care, three-point compression protocol.MethodsThe patient population consisted of patients with suspected DVT who presented to the emergency department between 2021 and 2022. All patients underwent a three-point compression ultrasound exam by the emergency resident. Each patient then had a comprehensive whole-leg ultrasonography exam performed by a supervisor emergency specialist. The results of the ultrasound exams by the emergency resident physicians and comprehensive exams were then analyzed and compared.ResultsThe average age of the patients was 60,96 ± 16,67. There was a statistically significant difference between three-point compression and whole-leg ultrasound examination data. The negative predictive value of the resident physician was determined as 94%. The coefficient of the compression variable in the Ridge regression analysis for diagnosing DVT in the whole-leg ultrasound examination was obtained as -0.3754.ConclusionsWe think that compression ultrasonography may be sufficient in patient management compared to whole-leg ultrasonography in emergency management. However, we think that three-point compression ultrasonography applied by the emergency resident is quite successful in diagnosing and excluding DVT in the emergency department.

PMID:40401508 | DOI:10.1177/17085381251342387

Categories
Nevin Manimala Statistics

Pharmacokinetics, Safety, and Tolerability of Single-Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double-Blind, Phase 1 Studies

Clin Pharmacol Drug Dev. 2025 May 22. doi: 10.1002/cpdd.1522. Online ahead of print.

ABSTRACT

Dazukibart is a humanized monoclonal antibody selectively targeting interferon-β. The pharmacokinetics (PK), safety, tolerability, and immunogenicity of dazukibart were evaluated in 2 double-blind, randomized, placebo-controlled, single-dose, Phase 1 studies in healthy adults in China (Study 1: N = 18; dazukibart 900 mg = 15; placebo = 3) and Japan (Study 2: N = 12; Cohort 1: dazukibart 300 mg = 5, placebo = 1; and Cohort 2: dazukibart 900 mg = 5, placebo = 1). PK parameters were assessed after dosing in Study 1 and Study 2, and no significant differences were observed between PK findings among participants in both studies. A biphasic decline in dazukibart serum concentrations was observed in both studies. Exposures increased dose proportionally in Study 2. Body weight, but not race, was identified as an independent covariate of exposure using population PK modeling (including data from a Phase 1 US study [NCT02766621]). No deaths/discontinuations or serious/severe adverse events were observed, mostly mild adverse events were reported. No participants in Study 1 were antidrug antibody positive; 20.0% in Study 2 were positive for treatment-induced antidrug antibodies and neutralizing antibodies. PK parameters and immunogenicity rates were consistent with the US study, and no new safety signals were identified.

PMID:40401504 | DOI:10.1002/cpdd.1522

Categories
Nevin Manimala Statistics

Insights into the copolymerization of metal-organic nanotubes from ligand mixtures using small angle neutron scattering

Nanoscale. 2025 May 22. doi: 10.1039/d4nr04820b. Online ahead of print.

ABSTRACT

Metal-organic nanotubes (MONTs) are porous, tunable 1D nanomaterials akin to metal-organic frameworks (MOFs). MONTs are synthesized via metal salts and coordinating ligands akin to MOFs, but crucially they are anisotropic, unlike most MOFs. Recently, MONTs have been shown to form statistically random copolymers; however, their mechanism of growth remains largely unexplored. Full realization of the potential of MONTs necessitates a thorough understanding of the mechanism of MONT growth. Herein, small-angle neutron scattering (SANS) was employed to investigate the copolymerization mechanism of two 1,2,4-ditriazole ligands and to quantify the inclusion of a solvent within the MONT pores. The results show parallelepiped-shaped structures are initially formed, which then aggregate to form larger lamellar structures. Additional experimentation with a deuterated ligand showed that the reactivities of all ligands are approximately equal, causing random ligand distribution within the resulting MONT. Finally, the results quantify the amount of solvent incorporated within the nanostructure pores at different stages of the formation process. These results show that early in the reaction the MONTs contain ca. 45% solvent, and they contain ca. 55% solvent late in the reaction when the MONTs are nearly fully formed.

PMID:40401467 | DOI:10.1039/d4nr04820b