Tag: pubmed

JAMA Health Forum. 2025 Oct 3;6(10):e253871. doi: 10.1001/jamahealthforum.2025.3871.

ABSTRACT

IMPORTANCE: The US has faced persistent antibiotic shortages over the past decade, compromising patient care, public health, and national security. Understanding the global sources of US antibiotic imports is critical to inform policies to improve supply chain resilience.

OBJECTIVE: To identify the global sources of US antibiotic imports, focusing on finished dosage forms (FDFs) and active pharmaceutical ingredients (APIs) between 1992 and 2024.

DESIGN AND SETTING: This cross-sectional study of US antibiotic importation records used data from USA Trade Online from January 1992 to July 2024. Data included import volumes, costs, and the originating country.

MAIN OUTCOMES AND MEASURES: Trends in annual import volumes for antibiotic FDFs and APIs (metric tons), spending and price per kilogram (inflation-adjusted dollars), and market concentration measured by the Herfindahl-Hirschman Index (HHI). An HHI less than 1500 indicates an unconcentrated (ie, competitive) market, 1500 to 2500 indicates a moderate concentration, and greater than 2500 indicates high concentration.

RESULTS: The final sample included 50 FDF-originating countries and 52 API-originating countries. Compared with the annual volume of US antibiotic FDF imports in 1992, the annual volume in 2024 increased 2595.0%, while the annual volume of API imports remained relatively stable. Mean inflation-adjusted importation prices for FDFs decreased from $1836.03 per kg in 1992 to $177.44 per kg in 2024. For APIs, mean prices decreased from $351.74 per kg in 2003 to $65.69 per kilogram in 2024. From 2020 to 2024, India was the leading originating country for FDFs (31.9% of the total imported volume and 18.2% of the total imported cost), followed by Italy (13.4% of the total volume and 22.4% of the total cost). China was the leading originating country for APIs (62.6% of the total imported volume and 28.7% of the total cost), followed by Bulgaria (16.1% of the total volume and 3.8% of the total cost). Italy was the originating country for 2.6% of API imported volume but accounted for 27.9% of the importation costs. HHI revealed that FDF importation has become unconcentrated since 2020 (HHI, 1500-2500), while API importation markets are highly concentrated (2024 HHI, >5000).

CONCLUSIONS AND RELEVANCE: This study found that US antibiotic importation relies on diversified global sources for FDFs but primarily on China for APIs. Policies to strengthen domestic production and diversify sourcing are critical to mitigate supply chain vulnerabilities. Improved traceability and targeted strategies for specific antibiotics are recommended to safeguard public health and national security.

PMID:41042525 | DOI:10.1001/jamahealthforum.2025.3871

JAMA Netw Open. 2025 Oct 1;8(10):e2535137. doi: 10.1001/jamanetworkopen.2025.35137.

ABSTRACT

IMPORTANCE: Hospital-acquired venous thromboembolism (HA-VTE) remains a leading cause of preventable death among hospitalized adults in the US. Despite numerous attempts to prognosticate HA-VTE with risk models, no single model has outperformed the rest, and the effectiveness of such models to drive prophylaxis decisions is unknown. Testing such systems in urban and rural settings may inform their generalizability.

OBJECTIVE: To conduct a randomized clinical trial to assess the effectiveness of artificial intelligence (AI)-driven clinical decision support (CDS) in reducing HA-VTE incidence in adults across urban and rural hospital settings.

DESIGN, SETTING, AND PARTICIPANTS: This parallel-group, single-blind, pragmatic randomized clinical trial is planned to be conducted from October 1, 2025, through September 30, 2027, by the Vanderbilt University Medical Center, a major academic health system in Tennessee. The study population will include adult (aged ≥18 years) patients admitted to medical, surgical, and intensive care units who may be at high risk for VTE and with no active or contraindication to deep vein thrombosis prophylaxis at Vanderbilt Adult Hospital in urban Nashville and 3 affiliated hospitals serving rural communities in Middle Tennessee.

INTERVENTION: Patients will be randomized 1:1 within the electronic health record to receive either VTE-AI-driven CDS (nudge practice alert [intervention arm]) or standard care using traditional risk assessment (control arm).

MAIN OUTCOME AND MEASURES: The primary outcome will be incidence of HA-VTE. Secondary trial outcomes will be process metrics, including length of stay, readmission rates, safety, and bleeding events. Outcomes will be analyzed using descriptive statistics and compared using Poisson regression.

DISCUSSION: Using a validated prognostic model, this study is one of the first to provide insights into whether AI-driven CDS can effectively reduce HA-VTE incidence without increasing adverse events. This study also is intended to provide insights into the usefulness of the same AI model implemented across urban and rural settings. The study’s findings and statistical code will be shared with the public through peer-reviewed publication and ClinicalTrials.gov.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06939803.

PMID:41042513 | DOI:10.1001/jamanetworkopen.2025.35137

JAMA Netw Open. 2025 Oct 1;8(10):e2535200. doi: 10.1001/jamanetworkopen.2025.35200.

ABSTRACT

IMPORTANCE: It is unclear whether performing surgery for most patients with an acute subdural hematoma (ASDH) and traumatic brain injury (TBI) is superior to conservative treatment.

OBJECTIVE: To compare the effectiveness of a strategy preferring acute surgical ASDH evacuation with one preferring initial conservative treatment.

DESIGN, SETTING, AND PARTICIPANTS: This comparative effectiveness study used data from February 1, 2014, to July 31, 2018, from the prospective observational Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study, conducted at 18 Level 1 trauma centers in the US. The study included patients with nonpenetrating TBI presenting to the emergency department and admitted within 24 hours after injury with ASDH detected on acute head computed tomography scan. Statistical analysis was performed from December 1, 2022, to December 20, 2024.

EXPOSURES: Acute surgical hematoma evacuation vs initial conservative treatment, comparing outcomes between centers according to treatment preferences, measured by the case mix-adjusted probability of undergoing acute surgery (vs conservative treatment) per center.

MAIN OUTCOMES AND MEASURES: Functional disability at 6 months was assessed with the Glasgow Outcome Scale-Extended at 6 months, analyzed with ordinal logistic regression adjusted for prespecified confounders, quantified with a common odds ratio (OR). Variation in center preference was quantified with a median OR (MOR).

RESULTS: Of 2697 included patients, 711 (mean [SD] age, 46.5 [19.4] years; 539 men [76%]) had an ASDH, of whom 148 (21%) underwent acute cranial surgery and 563 (79%) underwent initial conservative treatment. The acute surgery cohort had lower mean (SD) Glasgow Coma Scale scores (6.8 [4.4] vs 11.4 [4.6]), more pupil abnormalities (both pupils unreacting: 43 of 133 [32%] vs 41 of 477 [9%]), and fewer isolated ASDHs (eg, more with concurrent intracranial lesions; 92 of 133 [69%] vs 297 of 563 [53%%]) compared with the conservative treatment cohort. In the surgical cohort, 129 of 148 patients (87%) underwent decompressive craniectomy (DC), and 17 of 148 (11%) underwent craniotomy. In the conservative treatment cohort, 67 of 563 patients (12%) underwent delayed cranial surgery (DC or craniotomy). The proportion of patients undergoing acute surgery ranged from 0% to 86% (median, 17% [IQR, 5%-27%]) between centers, with up to a 3-fold higher probability of prognostically similar patients receiving acute surgery in one center compared with another random center (MOR, 2.95 [95% CI, 1.79-7.47]; P = .06). Center preference for acute surgery over initial conservative treatment was not associated with a better outcome (OR, 1.05 [95% CI, 0.88-1.26] per 22% [IQR, 5%-27%] increase in acute surgery at a given trauma center).

CONCLUSIONS AND RELEVANCE: In this comparative effectiveness study, similar patients with traumatic ASDH were treated differently due to center-specific treatment preferences. Outcomes were similar in centers preferring surgical evacuation and those preferring initial conservative treatment. This study suggests that, for a patient with ASDH for whom a neurosurgeon experiences clinical equipoise between acute surgery vs (initial) conservative treatment, conservative treatment may be considered.

PMID:41042512 | DOI:10.1001/jamanetworkopen.2025.35200

JAMA Netw Open. 2025 Oct 1;8(10):e2535330. doi: 10.1001/jamanetworkopen.2025.35330.

ABSTRACT

IMPORTANCE: Mammography screening is essential for the early detection of breast cancer; however, delayed detection among screen-detected breast cancers (SDBCs) is rarely studied.

OBJECTIVES: To investigate whether women diagnosed with SDBC who missed the screening round immediately before the diagnostic round experience clinically significant delays in detection and whether tumor characteristics vary.

DESIGN, SETTING, AND PARTICIPANTS: This prospective register-based cohort study included all women diagnosed with SDBC in Stockholm, Sweden, between January 1, 1995, and February 28, 2020, with a follow-up until December 31, 2022. Data were analyzed from November 5, 2023, to May 27, 2024.

EXPOSURE: Nonparticipation in the screening immediately prior to the diagnostic round.

MAIN OUTCOMES AND MEASURES: Tumor characteristics and breast cancer-specific survival.

RESULTS: Among 8602 women with SDBC (median age at diagnosis, 61 [IQR, 55-66] years), 1482 (17.2%) did not attend the immediate past screening. Nonparticipants in the past screening were more likely to have larger tumors (adjusted odds ratio [AOR], 1.55 [95% CI, 1.37-1.76] for a tumor size ≥20 mm), lymph node involvement (AOR, 1.28 [95% CI, 1.12-1.45), and distant metastasis (AOR, 4.64 [95% CI, 2.10-10.29]) and less likely to have estrogen receptor-negative breast cancer (AOR, 0.74 [95% CI, 0.60-0.92]); however, there were no differences in progesterone receptor status (AOR, 0.96 [95% CI, 0.83-1.11]) or ERBB2 (formerly HER2 or HER2/neu) status (AOR, 1.00 [95% CI, 0.81-1.24]). In addition, these women experienced poorer breast cancer-specific survival, with an adjusted hazard ratio (AHR) of 1.33 (95% CI, 1.08-1.65). There was no association after adjusting for tumor characteristics (AHR, 1.11 [95% CI, 0.89-1.38]). Additionally, no association was found between nonparticipation in the second-to-last screening and tumor characteristics among those with screen-detected breast cancers (AHR, 0.98 [95% CI, 0.80-1.19] for stage II tumors or higher).

CONCLUSIONS AND RELEVANCE: The findings of this cohort study suggest that some women with SDBC experience delayed detection and have clinically relevant worse outcomes. Future research is needed to investigate whether advancing the next mammography screening invitation date could enhance early detection and improve breast cancer outcomes in this population.

PMID:41042510 | DOI:10.1001/jamanetworkopen.2025.35330

JAMA Netw Open. 2025 Oct 1;8(10):e2535408. doi: 10.1001/jamanetworkopen.2025.35408.

ABSTRACT

IMPORTANCE: Medicare enrollees with low income report challenges affording out-of-pocket costs for health care. Although the Medicare Savings Programs (MSPs) were established to provide financial support, recent patterns in program take-up are understudied.

OBJECTIVES: To provide national and state-level estimates of take-up of the MSPs from 2018 to 2020 and describe the profile of enrolled and unenrolled individuals eligible for the MSPs.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional analysis used data from the Medicare Current Beneficiary Survey (MCBS), a nationally representative survey of community-dwelling Medicare beneficiaries. Respondents from 2018 to 2020 who completed the income and assets questionnaire, which allowed assessment of MSP eligibility, were analyzed. Data were analyzed in July 2024.

EXPOSURES: Eligibility for the MSPs.

MAIN OUTCOMES AND MEASURES: The take-up rate of the MSPs, defined as the proportion of eligible beneficiaries enrolled in the program. The MCBS survey weights were applied to create a subsample that was nationally representative of the community-dwelling Medicare population.

RESULTS: The primary sample included 26 240 respondent-year observations, representing 179 221 355 beneficiary-years (14.0% [95% CI, 13.4%-14.5%] of respondents were <65 years, 55.1% [95% CI, 54.1%-56.0%] were female, and 37.7% [95% CI, 36.0%-39.4%] had a high school education or lower). A total of 20.9% (95% CI, 19.8%-22.0%) of the primary sample was eligible for the MSPs. Of those eligible, 56.7% (95% CI, 54.5%-59.0%) were enrolled. Take-up rates varied widely across states, ranging from 41.5% (95% CI, 25.7%-57.3%) in Ohio to 72.9% (95% CI, 67.6%-78.2%) in California. Take-up among Medicare Advantage beneficiaries was higher than among those in traditional Medicare (61.3% vs 52.9%; difference, 8.4 percentage points [pp] [95% CI, 3.5-13.2 pp]). Compared with eligible beneficiaries who were not enrolled, enrolled individuals had greater economic insecurity, including being 30.0 pp (95% CI, 25.4-34.6 pp) more likely to report income below 100% of the federal poverty level and 16.4 pp (95% CI, 13.2-19.6 pp) more likely to report assets less than $3000.

CONCLUSIONS AND RELEVANCE: This cross-sectional study of Medicare beneficiaries suggests that MSP take-up remains incomplete and varied across states despite policy efforts. A policy to encourage participation in the MSPs among eligible populations that target less socially and financially vulnerable-although still with low income and eligible for the MSPs-individuals may be more likely to be associated with gains in the MSP take-up.

PMID:41042507 | DOI:10.1001/jamanetworkopen.2025.35408

Ir J Med Sci. 2025 Oct 3. doi: 10.1007/s11845-025-04108-x. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: This study investigated the relationship between preoperative Modified 5-item Frailty Score (mFI-5) and long-term survival as well as 30-day postoperative complications in patients who underwent radical cystectomy for bladder cancer.

METHODS: Patients who underwent radical cystectomy between 2012-2023 were analyzed and divided into two groups based on their mFI-5 scores: low-risk (≤ 1) and high-risk (≥ 2). Overall survival (OS), cancer-specific survival (CSS), and 30-day postoperative complications were compared between these groups. Additionally, Cox proportional hazards regression analysis was used to examine the impact of the mFI-5 score on OS and CSS.

RESULTS: Our study included 288 patients with an average age of 63.8 ± 9.1 years at the time of surgery. Patients with a low mFI-5 score comprised 77.4% (n = 223) of the cohort, while 22.6% (n = 65) had a high mFI-5 score. The majority of patients had advanced-stage disease (pT3-pT4 for 53.8% (n = 155)). Patients with a high mFI-5 score demonstrated significantly worse OS and CSS compared to those with a low mFI-5 score (p = 0.002 and p = 0.007, respectively). Although 30-day mortality rates were significantly higher in the high mFI-5 score group (p = 0.002), the difference in overall complication rates was not statistically significant (p = 0.120). In multivariate Cox proportional hazards analysis, the mFI-5 score was identified as an independent predictor for both OS and CSS (p = 0.001 and p = 0.003, respectively).

CONCLUSION: mFI-5 score can provide valuable prognostic information regarding survival after radical cystectomy in bladder cancer patients, based on preoperative findings. It is an independent predictor of long-term survival.

PMID:41042491 | DOI:10.1007/s11845-025-04108-x

Infection. 2025 Oct 3. doi: 10.1007/s15010-025-02644-3. Online ahead of print.

ABSTRACT

BACKGROUND: Sepsis survivors are affected by a broad spectrum of long-term impairments, which overlap with Long-Covid and sequelae after influenza in their clinical presentation. However, we lack comparative assessments on the burden of long-term outcomes, particularly with patients being recruited from the same, contemporary patient population. Therefore we compared long-term outcomes after respiratory sepsis (RS), SARS-CoV-2-associated sepsis (SS) and influenza-associated sepsis (IS).

METHODS: Retrospective, population-based cohort study. We included patients > 15 years hospitalized with RS, SS and IS between 01/2020 and 12/2020 in Germany, who received intensive care unit treatment. We compared mortality, readmissions, prevalence of diagnoses in the cognitive, psychological or medical domain, and the number of impaired domains in the 12 months post-discharge between the three survivor cohorts, adjusting for between-group differences in relevant covariates by inverse propensity score weighting based on generalized propensity scores.

RESULTS: Our study included 12,854 patients, of which 8,201 were RS, 3,964 SS and 689 IS survivors. RS survivors had a considerably higher risk for 12-month mortality compared to SS and IS survivors (relative risk, 1.77 [95% CI, 1.54-2.03]; P < 0.001 and relative risk, 1.37 [95% CI, 1.14-1.65]; P = 0.001, respectively). They were more often rehospitalized, affected by multiple domain impairments, cognitive decline and impairments related to the severity of acute disease, e.g. complications of the tracheostoma, compared to survivors after SS and IS. RS survivors had a lower risk for being affected by medical diagnoses compared to SS. Risks for psychological diagnoses did not differ between RS and the other survivor groups.

CONCLUSIONS: Although respiratory sepsis survivors seem to be affected by more severe long-term impairments, the overall burden of post-acute sequelae among all survivor groups is high. This warrants efforts to provide targeted aftercare for all survivor populations after life-threatening infections.

PMID:41042487 | DOI:10.1007/s15010-025-02644-3

Sports Med. 2025 Oct 3. doi: 10.1007/s40279-025-02303-5. Online ahead of print.

ABSTRACT

BACKGROUND: With the increasing use of artificial intelligence in healthcare and sports science, large language models (LLMs) are being explored as tools for delivering personalized, evidence-based guidance to athletes.

OBJECTIVE: This study evaluated the capabilities of LLMs (ChatGPT-3.5, ChatGPT-4, and Google Bard) to deliver evidence-based advice on sleep and jet lag for athletes.

METHODS: Conducted in two phases between January and June 2024, the study first identified ten frequently asked questions on these topics with input from experts and LLMs. In the second phase, 20 experts (mean age 43.9 ± 9.0 years; ten females, ten males) assessed LLM responses using Google Forms surveys administered at two intervals (T1 and T2). Inter-rater reliability was evaluated using Fleiss’ Kappa, and intra-rater agreement using the Jaccard Similarity Index (JSI), and content validity through the content validity ratio (CVR). Differences among LLMs were analyzed using Friedman and Chi-square tests.

RESULTS: Experts’ response rates were high (100% at T1 and 95% at T2). Inter-rater reliability was minimal (Fleiss’ Kappa: 0.21-0.39), while intra-rater agreement was high, with 53% of experts achieving a JSI ≥ 0.75. ChatGPT-4 had the highest CVR for sleep (0.67) and was the only model with a valid CVR for jet lag (0.68). Google Bard showed the lowest CVR for jet lag (0%), with significant differences compared to ChatGPT-3.5 (p = 0.0073) and ChatGPT-4 (p < 0.0001). Reasons for inappropriate responses varied significantly for jet lag (p < 0.0001), with Google Bard criticized for insufficient information and frequent errors. ChatGPT-4 outperformed other models overall.

CONCLUSIONS: This study highlights the potential of LLMs, particularly ChatGPT-4, to provide evidence-based advice on sleep but underscores the need for improved accuracy and validation for jet lag recommendations.

PMID:41042486 | DOI:10.1007/s40279-025-02303-5

Sports Med. 2025 Oct 3. doi: 10.1007/s40279-025-02306-2. Online ahead of print.

ABSTRACT

BACKGROUND: Normative dual-task (concurrent cognitive and motor task) tandem gait has not been developed. Currently, only individual baseline data are used for tandem gait assessment post concussion.

OBJECTIVE: The object was to (1) determine factors associated with single-task and dual-task tandem gait time among collegiate athletes across multiple institutions, and (2) provide robust normative data for single-task and dual-task tandem gait time based on clinically relevant factors.

METHODS: Data were analyzed from 2,137 unique collegiate athletes (19.0 ± 1.1 years, 48.9% female, 23.7% with concussion history) from 2015 to 2022 during pre-injury baseline concussion testing from three universities. Tandem gait was performed under single- and dual-task conditions (serial subtraction by sixes/sevens, spelling five-letter words backward, reciting the months backward). The criteria for being a clinically relevant independent variable was (a) p value < 0.05, and (b) effect estimate of ≥ 1 s. Normative data based on established percentile thresholds were derived and stratified by clinically relevant factors.

RESULTS: None of the single-task tandem gait times were clinically relevant, while sex and contact level were for dual task. Mean (95% confidence interval) for overall single- and dual-task tandem gait times were 12.07 s (11.95, 12.19) and 16.51 s (16.29, 16.73), respectively.

CONCLUSION: Our results provide robust normative data for single- and dual-task tandem gait stratified by relevant patient factors that can be immediately used by clinicians and future researchers. Future research should compare the use of individual baseline versus normative data for acute concussion tracking.

PMID:41042485 | DOI:10.1007/s40279-025-02306-2

Reprod Sci. 2025 Oct 3. doi: 10.1007/s43032-025-01992-7. Online ahead of print.

ABSTRACT

The effect of polycystic ovary syndrome (PCOS) on the fatty acid (FA) content of follicular fluid (FF) is not fully understood. The present study aimed to determine whether the FA composition of FF phospholipids (PLs) and triglycerides (TGs) undergoes alterations in women with PCOS. A total of 40 subjects, including 20 PCOS patients and 20 controls, were enrolled. Thin-layer chromatography followed by gas chromatography was carried out to isolate FF lipid fractions and measure relative concentrations of their FAs, respectively. Percentages of individual FAs in FF PLs and TGs did not statistically differ between the control and PCOS groups (p > 0.05), other than palmitoleic acid, which significantly decreased and increased in PLs and TGs of women with PCOS, respectively (p < 0.05). There were positive correlations between intrafollicular levels of androgens and PL levels of several n-6 polyunsaturated FAs in the PCOS group (r > 0.4, p < 0.05). In addition, relative concentrations of eicosapentaenoic acid in both PL and TG fractions were inversely correlated with the fertilization rate (r < -0.4, p < 0.05). PCOS women with positive pregnancy outcomes also had higher PL and TG stearic acid with concomitant lower docosahexaenoic acid and peroxidizability index in PL and TG fractions, respectively (p < 0.05). It could be concluded that PCOS was associated with minor alterations in the FA composition of FF PLs and TGs. Furthermore, there were differential fraction-dependent associations between FF FA profile and biochemical and reproductive parameters in women with PCOS.

PMID:41042473 | DOI:10.1007/s43032-025-01992-7