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Emergency

Sources: NEJM, JAMA Network Open, Cochrane, Annals EM. Society hubs are outbound links, not scraped bodies.

Indexed items

Showing 80 of 1668 matching items (19450 indexed).

Annals EMArticle

Annals of emergency medicine · ACEP

Childhood Mental Health-Related Visits and Emergency Department Pediatric Volume in the United States, 2016 to 2022.

STUDY OBJECTIVES: Pediatric mental health emergency department (ED) visits are increasing, yet differences in presentations by ED type are not well described. Our objective was to examine characteristics of pediatric mental health-related ED visits by annual pediatric ED volume. METHODS: We conducted a retrospective cross-sectional study of ED visits among children 5 to 17 years with a primary mental health diagnosis, identified by International Classification of Diseases, Tenth Revision, Clinical Modification codes, using the 2016 to 2022 Nationwide Emergency Department sample. The outcome was presentation to an ED with high annual pediatric volume (≥10,000 visits). Using multivariable logistic regression modeling, we examined the association with patient- and hospital-level characteristics, reporting adjusted odds ratios and 95% confidence intervals (CIs). RESULTS: We identified 5,369,821 weighted mental health-related visits (4.7% low, 21.2% medium, 24.1% medium-high, and 50.1% high annual pediatric volume). The adjusted odds of presenting to a high compared with a low/medium/medium-high annual pediatric volume ED were higher among non-Hispanic Black (1.19, 95% CI 1.05, 1.35) and lower among Native American (0.54, 95% CI 0.35, 0.83) children compared with non-Hispanic White children. The adjusted odds were lower for individuals with substance-related diagnoses (0.79, 95% CI 0.71, 0.87) compared with those with suicide and self-injury. CONCLUSION: Pediatric mental health-related ED visits vary by patient characteristics and diagnoses across EDs with different annual pediatric volume categories. Findings may inform opportunities to develop and deploy ED-based interventions to improve pediatric mental health outcomes across diverse populations and settings.

JAMAArticle

JAMA

COVID-19 Vaccine Effectiveness and Safety for the 2026-2027 Respiratory Season.

IMPORTANCE: SARS-CoV-2 remains a substantial cause of respiratory illness, morbidity, and mortality. Evidence to date has demonstrated that COVID-19 vaccines reduce the risk of severe disease, including hospitalization and death. OBJECTIVE: This systematic review identifies and summarizes newly published studies reporting on the effectiveness and safety of COVID-19 vaccines and COVID-19 epidemiology in the US. EVIDENCE REVIEW: Cochrane Central Register of Controlled Trials, PubMed/MEDLINE, Embase, and Scopus were searched from August 1, 2025, through June 29, 2026. Studies were eligible if they reported on the effectiveness, efficacy, or safety of a US-licensed COVID-19 vaccine or SARS-CoV-2 epidemiology in the US. FINDINGS: From 11 829 identified references, 155 publications were eligible (15 randomized clinical trials, 84 observational studies with a comparator group, 38 product safety studies without a comparator group [single group], and 18 descriptive studies of disease burden). Consistent with prior evidence, studies reported that updated COVID-19 vaccines were associated with a reduction in the risk of hospitalization among both older adults (≥65 years; vaccine effectiveness [VE], 53.0%; 95% CI, 37.0%-65.0%; 2025-2026 season) and adults (18-64 years; VE, 54.0%; 95% CI, 1.0%-78.0%; 2024-2025 season). Maternal vaccination was associated with reduced risk of COVID-19-associated emergency department/urgent care encounters among individuals vaccinated (VE, 58.0%; 95% CI, 24.0%-77.0%) and with fewer COVID-19-related hospital contacts in the first 2 months of life among infants born subsequently (VE range, 50.0%-54.0%), regardless of trimester of vaccination. Vaccination was also associated with a significant reduction in COVID-19-related pediatric emergency department visits (9 months to 4 years; VE, 76.0%; 95% CI, 58.0%-87.0%). Vaccination was associated with a reduced risk of critical COVID-19 illness (intensive care unit admission or death) in immunocompromised adults (VE range, 32.0%-53.0%, depending on condition and other factors). Health care personnel who received 3 to 5 vaccine doses were less likely to develop laboratory-confirmed COVID-19 illness (VE, 41.0%; 95% CI, 34.0%-47.0%) and postacute COVID-19 symptoms (VE, 57.0%; 95% CI, 46.0%-66.0%) compared with those who received only 2 doses. Across adverse events of special interest (eg, stroke, thrombosis, myocarditis), safety profiles were consistent with those of previous reviews. No identified studies conducted under the updated guidance on extended dosing intervals for the primary series reported an increased risk of myocarditis or pericarditis. No new safety signals were reported in the recently published studies eligible for this updated review of US-licensed COVID-19 vaccines. CONCLUSIONS AND RELEVANCE: COVID-19 vaccines were consistently associated with a reduction in the risk of hospitalization and other outcomes, including among individuals at high risk of severe COVID-19, such as infants, and those who were pregnant. No new safety concerns were identified.

NatureArticle

Nature

Functional chimeric mRNAs encode proteins in mammalian immunity.

Individual mammalian mRNAs and proteins are typically believed to originate from single genomic loci, with isoform diversity arising through cis-splicing of pre-mRNA. Whether mRNA from distant genes can undergo trans-splicing to generate functionally relevant chimeric transcripts has remained unclear. Here we develop a pipeline combining long-read direct RNA sequencing with non-targeted and targeted validation to identify chimeric transcripts in macrophages. Chromatin conformation capture studies reveal that inflammation induces interchromosomal DNA interactions, positioning parent genes proximally to facilitate the formation of chimeric mRNA. Notably, we identify a protein-coding chimeric mRNA representing a fusion between the pore-forming protein gasdermin D (GSDMD)and a C-terminal domain translated out of frame from Tmem106a (Gsdmd-Tmem106a) in mice. We show that inflammasome priming upregulates Gsdmd-Tmem106a, with the protein localizing to the plasma membrane. After activation of the inflammasome, GSDMD-TMEM106A directly interacts with canonical GSDMD N termini to accelerate and enhance pore formation and IL-1β release. Finally, we show that GSDMD-TMEM106A balances host defence and immunopathology in vivo: its loss protects against lethal sepsis but compromises antibacterial defence, whereas overexpression enhances host protection while increasing sepsis lethality. We establish that protein-coding chimeric mRNAs formed by regulated transcript fusion events are operative during inflammation and immunity.

Annals EMArticle

Annals of emergency medicine · ACEP

Will Artificial Intelligence Replace Me? Automation Susceptibility of Emergency Physician Tasks.

STUDY OBJECTIVE: To apply Autor's labor economics task framework to classify emergency physician tasks by automation susceptibility and map current artificial intelligence (AI) capabilities to each category. METHODS: We synthesized 6 published time-motion studies, ACGME Core Entrustable Professional Activities, and the O∗NET emergency physician task inventory into a unified list of 14 task categories. Two board-certified emergency physicians independently classified each task using Autor's 4-category framework. Current AI capabilities were mapped to each task using a 3-tier schema: Replace, Augment, or No Current Application. RESULTS: Nine tasks (64.3%) were classified as nonroutine abstract, 3 (21.4%) as routine cognitive, and 2 (14.3%) as nonroutine manual. No tasks were Routine Manual. AI replacement is concentrated in routine cognitive tasks (documentation, medical records review, emergency department operations management), which consume 20% to 40% of physician shift time. Augmentation dominates in nonroutine abstract domains. Nonroutine manual tasks show minimal AI penetration. CONCLUSION: Routine cognitive tasks consume a disproportionate share of emergency physician shift time, making them the immediate target for AI-driven workflow restructuring. Beyond this, augmentation of nonroutine abstract tasks is accelerating, warranting ongoing reassessment of automation boundaries across all task categories. As AI capabilities continue to expand, structured task-level analyses of this kind will be essential for anticipating workforce needs and informing AI implementation strategy, residency training design, and physician preparation in emergency medicine.

JAMA Network OpenArticle

JAMA network open

Balanced Component and Whole-Blood Transfusion Practices in US Trauma Centers.

IMPORTANCE: Balanced transfusion is a cornerstone of modern hemorrhage resuscitation, yet national adoption patterns and hospital practice variation remain poorly characterized, particularly following increasing use of whole blood (WB). OBJECTIVE: To evaluate trends, between-hospital variation, and patient and institutional factors associated with balanced component and WB transfusion in US trauma centers. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study of adult trauma patients in hemorrhagic shock receiving blood transfusion within 4 hours of hospital arrival used data from the Trauma Quality Improvement Program (2018-2024). Multilevel mixed-effects logistic regression was used to evaluate patient and hospital characteristics associated with balanced component and WB use and quantify hospital-level variation. EXPOSURE: Patient demographic and injury characteristics, hospital structural characteristics, and calendar year. MAIN OUTCOMES AND MEASURES: The primary outcome was balanced component and WB use within 4 hours of arrival, defined by standardized ratios of plasma to red blood cells and platelet to red blood cells or receipt of WB. Temporal trends and facility variation were assessed using adjusted odds ratios (ORs), intraclass correlation coefficients, and median ORs. RESULTS: The study included 71 997 patients treated at 650 trauma centers (197 [30.3%] American College of Surgeons-verified level I). The median (IQR) age was 36.0 (26.0-52.0) years, 54 889 patients (76.2%) were male, and 45 185 patients (62.8%) sustained blunt injury. Balanced component and WB transfusion increased from 12.4% (918 transfusions) in 2018 to 37.6% (4244 transfusions) in 2024 (adjusted OR, 5.33; 95% CI, 4.88-5.81), largely corresponding to increasing WB adoption after 2020, whereas component-based balanced transfusion remained relatively stable. Significant between-hospital variation persisted after adjustment. Hospital-level differences accounted for 24% of variation in balanced component and WB use (intraclass correlation coefficient, 0.24; 95% CI, 0.21-0.26). Male sex, helicopter transport, and treatment at larger hospitals were associated with higher odds of balanced component and WB use, whereas major hemorrhage control surgery and severe torso injuries were negatively associated, despite higher total transfusion volumes. CONCLUSIONS AND RELEVANCE: In this retrospective cohort study of trauma patients at risk of hemorrhagic shock, the use of balanced component and WB use increased from 2018 to 2024, reflecting increasing WB adoption. Substantial between-hospital variation persisted. These findings can inform evaluation of hospital-level variation and future implementation of balanced transfusion practices across trauma centers.

JAMA Network OpenRCT

JAMA network open

Care Navigation for Methamphetamine Use Disorder: A Randomized Clinical Trial.

IMPORTANCE: Stimulant-involved deaths continue to increase in the US, and methamphetamine use remains a weighty public health concern. Treating methamphetamine use disorders is complicated. Contingency management has demonstrated the best effectiveness but is not widely implemented. OBJECTIVE: To examine the effectiveness of dedicated care navigation in linking patients to treatment. DESIGN, SETTING, AND PARTICIPANTS: This prospective randomized clinical trial was conducted at an integrated safety-net health system in Denver, Colorado, between April 10, 2023, and December 31, 2024. Eligible participants were 18 years or older who had a methamphetamine-related encounter in an acute care setting; those with involuntary treatment holds, substance treatment in past 90 days or actively seeking treatment, and inability to provide consent were excluded. Participants completed baseline, 30-day, and 90-day study visits. INTERVENTION: Dedicated care navigation, incorporating contingency management principles, with a focus on addressing health-related social needs. MAIN OUTCOMES AND MEASURES: Linkage to treatment within 30 and 90 days of enrollment defined as a composite measure of at least 1 of the following: electronic health record data indicating a visit at the health system's substance treatment clinic, a behavioral health encounter at an outpatient clinic, temporary residential treatment, or self-reported treatment on the 30- and/or 90-day follow-up survey. RESULTS: Of 192 participants enrolled in the Beginning Early and Assertive Treatment for Methamphetamine Use trial, 156 (81.3%) were male, and the median age was 39 (IQR, 31-47) years. Most participants were unstably housed (163 [84.9%]), not currently employed (158 [82.3%]), and without regular access to a working phone (94 [49.0%]). Of the 96 participants randomized to the intervention, 60 (62.5%) engaged in 2 or more navigation sessions, 45 (46.9%) completed the 30-day study visit, and 47 (49.0%) completed the 90-day study visit compared with 44 (46.3%) and 37 (38.5%), respectively, of the 96 randomized to the control arm. No statistically significant differences in treatment linkage were observed at 30 days (24 participants [25.0%] in both arms; risk ratio, 1.00 [95% CI, 0.61-1.63]) or 90 days post enrollment, (32 [33.3%] in intervention vs 24 [25.0%] in control arms; risk ratio, 1.33 [95% CI, 0.85-2.09]). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, integrating principles of contingency management into the intervention may have increased engagement with a dedicated care navigator but did not increase likelihood of linkage to treatment for methamphetamine use disorder. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06033365.

CochraneSystematic review

The Cochrane database of systematic reviews · Cochrane

Factors that impact on healthcare workers' adherence with infection prevention and control (IPC) guidelines for COVID-19: a qualitative evidence synthesis.

BACKGROUND: The COVID-19 pandemic, declared in 2020, brought unprecedented challenges to our healthcare services in relation to the prevention and treatment of the disease. Additionally, preventing transmission within healthcare settings was critical. Infection Prevention and Control (IPC) guidelines are important for providing strategies on the use of personal protective equipment (PPE), the separation of patients with respiratory infections from others, and stricter cleaning routines. It is important to examine how the context of the pandemic impacts healthcare workers' (HCW) ability to adhere to IPC guidance in pandemic situations in the future. This is an update of an earlier review version, published in 2020, titled 'Barriers and facilitators to healthcare workers' adherence with infection prevention and control (IPC) guidelines for respiratory infectious diseases: a rapid qualitative evidence synthesis'. We built on available evidence for infectious respiratory diseases, but also importantly, given the unprecedented global scale of COVID-19 and its unique challenges for healthcare systems, explored additional factors influencing IPC adherence specific to respiratory diseases with pandemic potential, i.e. infectious respiratory pathogens (such as novel influenza subtypes or coronaviruses) judged capable of causing a pandemic. OBJECTIVES: Our primary objective is to identify the factors that impact on HCWs' adherence to IPC guidelines for COVID-19. A second objective is to update an existing rapid review, published in 2020, to identify similarities, differences, and novel insights specific to COVID-19 compared with other respiratory infectious diseases. SEARCH METHODS: We searched MEDLINE (Ovid), CINAHL (EBSCO), Scopus, Ovid PsycINFO (EBSCO), and Epistemonikos. We did not apply any language limits but only searched from 2020 to the present (last search 5 April 2024). In the interest of timeliness and relevance, we only included studies published from 2020. We chose this as it marks the year when the COVID-19 pandemic was declared. SELECTION CRITERIA: We included qualitative and mixed methods studies that focused on the experiences and perceptions of HCWs towards factors that impact on their ability to adhere to IPC guidelines for COVID-19. We included studies of any type of healthcare worker with responsibility for patient care. We included studies that focused on IPC guidelines (local, national, or international) for COVID-19 in any healthcare setting. We excluded studies that collected data using qualitative methods (e.g. open-ended survey questions) in which the response data were analysed only with descriptive statistics. DATA COLLECTION AND ANALYSIS: We used a purposive sampling frame to identify data-rich studies that represented a range of HCWs, healthcare settings, and geographical spread. We assessed methodological strengths and limitations in the same studies using an adapted version of the Critical Skills Appraisal Programme (CASP) tool for qualitative studies. We used the 'best-fit framework approach' to analyse and synthesise the evidence from our included studies. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. We examined each review finding to identify factors that may influence guideline adherence and developed implications for practice. MAIN RESULTS: We found 170 studies eligible for inclusion; of these, 26 were sampled for analysis using a purposive sampling frame for a balance of variation and richness of data. Seven of the 26 sampled studies were from high-income countries. Of the 15 middle-income countries, seven were upper middle-income countries, and eight were lower middle-income countries. There were four low-income countries included in the sample. In terms of geographical spread, ten were from Asia, eight from Africa, three were from North America, one from South America, one from Oceania, and three from Europe. Most of the studies included nurses (15 studies) or doctors (11 studies). Other types of healthcare workers included in the studies were other clinical staff (11 studies), such as midwives, allied health professionals, medical and radiologic technologists, dental professionals, neonatologists, radiographers, pharmacists, and support staff (7 studies), such as hospital cleaners, clerical staff, technicians, and hospital attendants. Healthcare settings ranged across and within studies, including hospitals, long-term care settings, and community healthcare settings. Specific units such as maternity, intensive care, emergency care, critical care, and operating rooms were identified in five of the sampled studies. We identified 27 findings that outline the factors that impact on HCWs' adherence to IPC guidelines. We have low (n = 3), moderate (n = 12), and high (n = 12) confidence in these findings. HCWs found it easier to follow IPC guidelines with managerial support, and when IPC guidelines were communicated in a clear, structured, and accessible way. They found it more difficult to follow guidelines if they were busy, short-staffed, or when patients and visitors refused to wear masks and maintain social distancing. Training was considered very important, but not all HCWs had the opportunity to attend IPC training. In terms of the working environment, HCWs need adequate space, hand-washing stations, and showers to follow the IPC guidelines. HCWs worried about infecting other people, but some worried less once people started being vaccinated. It was very important that all HCWs had sufficient and equitable access to PPE and other supplies to follow guidelines. If PPE did not fit properly or was not of good quality, it was more difficult for HCWs to practice IPC. Many factors affect HCWs' willingness and ability to follow IPC guidelines. Our review includes a set of questions based on our findings to help healthcare providers plan, implement, or manage IPC strategies to help their workers follow IPC guidelines for pandemic diseases like COVID-19. It is worth noting that our included studies were conducted primarily during the earlier phase of the pandemic, based on practical considerations to not update the search after April 2024. AUTHORS' CONCLUSIONS: We identified several factors that influence the ability of healthcare workers to adhere to IPC guidelines. Practical implications, such as communication strategies and the provision of training and supplies, should guide policymakers and decision-makers in disease outbreaks and future pandemics. FUNDING: This Cochrane review had no dedicated funding. REGISTRATION: This Cochrane review extends the work by a published rapid review, available via DOI: 10.1002/14651858.CD013582.

JAMA Network OpenArticle

JAMA network open

Neurodegenerative Disease Death Certification Among National Football League Players With Dementia.

IMPORTANCE: Researchers frequently use death certificate data to evaluate occupational risks among National Football League (NFL) players, demonstrating elevated neurodegenerative mortality risk. Robust epidemiologic data suggest deaths attributable to neurodegenerative disease (NDD) are frequently underreported on death certificates, leading to substantial underascertainment of neurodegenerative mortality. Better characterization of the factors underlying neurodegenerative death certification is critical to addressing underreporting of NDDs, informing disease surveillance and resource allocation. OBJECTIVE: To elucidate clinical, exposure, and neuropathologic factors associated with neurodegenerative death certification. DESIGN, SETTING, AND PARTICIPANTS: This cohort study included 202 brain donors with clinician-adjudicated dementia who underwent postmortem neuropathologic assessment and retrospective clinical assessment with informants from February 15, 2008, to December 30, 2021, to ascertain clinical and lifetime exposure history. Statistical analysis was performed from October 2025 to June 2026. EXPOSURE: NFL career. MAIN OUTCOMES AND MEASURES: Neuropathologic diagnosis based on established diagnostic criteria, as well as informant-reported clinical measures and exposure history. Multiple logistic regression analysis was conducted to examine the association between factors and NDD death certification, adjusted for age at death, race and ethnicity, and educational level. RESULTS: Of 202 male brain donors (mean [SD] age at death, 73.1 [10.5] years) with clinician-adjudicated dementia, 62 (30.7%) had a neurodegenerative underlying cause of death listed on their death certificate. Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Global Executive Composite T-score (odds ratio [OR], 1.04; 95% CI, 1.01-1.06), BRIEF-A Metacognition Index T-score (OR, 1.03; 95% CI, 1.01-1.06), Cognitive Difficulties Scale score (OR, 1.02; 95% CI, 1.01-1.03), and Functional Activities Questionnaire score (OR, 1.13; 95% CI, 1.06-1.21), as well as a history of emergency department treatment for head injury (OR, 4.11; 95% CI, 1.72-9.82), were associated with increased odds of neurodegenerative death certification. High Alzheimer disease neuropathology (OR, 5.27; 95% CI, 1.93-14.40), frontotemporal lobar degeneration (OR, 4.48; 95% CI, 1.61-12.50), Braak stage IV to VI (OR, 2.99; 95% CI, 1.54-5.79), frequent diffuse plaques (OR, 4.21; 95% CI, 1.56-11.38), moderate to severe neuritic plaques (OR, 3.42; 95% CI, 1.55-7.54), and Thal phase 4 (OR, 4.50; 95% CI, 1.39-14.60) were associated with increased odds of neurodegenerative death certification. CONCLUSIONS AND RELEVANCE: This cohort study found that only 30.7% of brain donors with clinician-adjudicated dementia had neurodegenerative death certification. These results add to growing evidence of frequent NDD underascertainment where more severe disease is associated with neurodegenerative death certification, offering insight into factors that must be considered when using death certificate data to assess NDD burden. Factors such as worsened executive functioning and cognitive symptoms, greater functional impairment, and more severe neuropathology may be associated with an increased likelihood of neurodegenerative death certification among NFL players.

JAMA Network OpenArticle

JAMA network open

No-Flow Duration and Outcomes After Cardiogenic Out-of-Hospital Cardiac Arrest in Older Adults.

IMPORTANCE: The burden of cardiogenic out-of-hospital cardiac arrest (OHCA) among older adults is increasing. No-flow time is a key determinant of prognosis, and the aging brain may be increasingly vulnerable to ischemic injury during this interval. OBJECTIVE: To delineate the association between no-flow duration and outcomes in older adults with cardiogenic OHCA using dynamic probability curves. DESIGN, SETTING, AND PARTICIPANTS: This nationwide, population-based, multicenter retrospective observational cohort study used data from the All-Japan Utstein Registry from January 1, 2010, through December 31, 2023. Participants included adults 65 years or older with witnessed cardiogenic OHCAs treated within Japan's nationwide emergency medical service (EMS) system. Data were analyzed from December 1, 2025, to July 7, 2026. EXPOSURE: No-flow time, defined as the interval from witnessed arrest to initiation of cardiopulmonary resuscitation by EMS clinicians. MAIN OUTCOMES AND MEASURES: The primary outcome was 30-day favorable neurologic outcome, defined as cerebral performance category of 1 or 2. Age-stratified dynamic probability curves were constructed for patients aged 65 to 74 years, 75 to 84 years, 85 to 94 years, and 95 years or older to describe the time-dependent likelihood of outcome according to no-flow duration. For each age group, the no-flow time at which the estimated probability fell below 1% with 95% CIs was identified. RESULTS: Among 1 795 502 registry cases, 259 851 patients met the inclusion criteria. The median patient age was 82 (IQR, 75-88) years, 148 018 (57.0%) were male, and the median no-flow time was 11 (IQR, 8-15) minutes. Overall, 8711 patients (3.4%) achieved a 30-day favorable neurologic outcome. In all patients 65 years or older, the no-flow times at which the estimated probability of favorable neurologic outcome fell below 1% was 11 (95% CI, 11-11) minutes. Corresponding thresholds for favorable neurologic outcome was 14 (95% CI, 14-14) minutes for those aged 65 to 74 years, 11 (95% CI, 10-11) minutes for those aged 75 to 84 years, 2 (IQR, 0-4) minutes for those aged 85 to 94 years, and 0 (95% CI, 0-0) minutes for those 95 years or older. CONCLUSIONS AND RELEVANCE: In this cohort study of older adults with cardiogenic OHCA, the no-flow time window compatible with an estimated probability of at least 1% for favorable neurologic outcome became progressively shorter with advancing age. These findings may inform resuscitation decision-making in aging populations.

Oto-HNSArticle

Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · AAO-HNS

Predictors of Recurrent Croup: The Role of Social Determinants of Health and Otolaryngology Evaluation.

OBJECTIVE: To evaluate the influence of patient comorbidities, social determinants of health (SDOH), and otolaryngology (OTO) referral timing on disease course and healthcare utilization among pediatric patients with recurrent croup. STUDY DESIGN: Retrospective cohort study. SETTING: Large tertiary children's hospital. METHODS: Pediatric patients (0-18 years) evaluated by an OTO for recurrent croup between 2011 and 2024 were included (n = 70). Demographic, clinical, and referral data were obtained from medical records. SDOH were quantified using state-standardized Childhood Opportunity Index (COI) 3.0 scores across 3 domains and 14 subdomains. Associations between comorbidities, SDOH, and referral timing with disease duration, number of emergency department (ED) visits, corticosteroid prescriptions, and age at resolution were analyzed using t-tests and correlation coefficients (α = 0.05). RESULTS: Household tobacco exposure and gastroesophageal reflux disease were associated with earlier croup onset (P < .05). Higher Wealth, Health Resource, and Educational Resource scores correlated with shorter disease duration, fewer ED visits, and younger age at resolution (P < .05). Shorter intervals from first ED visit to OTO evaluation correlated with fewer ED visits (r = 0.28, P < .02), fewer corticosteroid prescriptions (r = 0.28, P < .02), and shorter disease duration (r = 0.51, P < .0001). CONCLUSION: Early otolaryngology involvement and favorable SDOH-particularly wealth, health, and educational resources-were associated with improved outcomes in recurrent croup. These findings highlight opportunities for targeted counseling, timely referral, and community-based interventions to reduce healthcare burden and enhance pediatric airway care. LEVEL OF EVIDENCE: III.

Annals EMArticle

Annals of emergency medicine · ACEP

Dexmedetomidine Continuous Infusion to Maintain Sedation in Severely Agitated Adolescents in the Emergency Department.

STUDY OBJECTIVES: Adolescents with severe agitation may require repeated administration of sedatives. We describe dexmedetomidine infusion as a novel bridge therapy for selected agitated adolescents awaiting psychiatric treatment and disposition. METHODS: We retrospectively studied adolescents (12 to 17 years) treated with dexmedetomidine infusion for severe agitation at our emergency department (ED) over a 16-month period. We abstracted demographics, sedatives administered, psychiatric therapy, type and frequency of adverse events, and ED disposition. Our primary outcome was the need for additional sedation despite dexmedetomidine. RESULTS: The median age of our 20 qualifying patients was 15 years. The median duration of dexmedetomidine infusion was 21 hours, with a median maximum dose of 1.6 mcg/kg per hour. During the infusion, 9 patients (45%, 95% confidence interval 26% to 66%) required additional sedation. One patient experienced desaturation responding to head repositioning and supplemental oxygen. Five patients were transferred to the pediatric ICU owing to the need of multiple sedatives. CONCLUSION: Our preliminary results support the feasibility of dexmedetomidine infusion as bridge sedation for selected severely agitated adolescents awaiting psychiatric care and disposition.

NEJMArticle

The New England journal of medicine

Immediate Ambulatory Electrocardiographic Monitoring in Syncope.

BACKGROUND: In patients with syncope who present to the emergency department for evaluation, diagnosing an underlying cardiac arrhythmia remains difficult. METHODS: We conducted an open-label, randomized, controlled trial at 45 hospitals in the United Kingdom to assess the effects of 14-day cardiac monitoring on diagnosis, treatment, and outcomes among patients with syncope. Adults with syncope that remained unexplained after an evaluation in the emergency department were assigned in a 1:1 ratio to undergo 14-day ambulatory electrocardiographic (ECG) monitoring (the intervention group) or to receive the standard care provided for patients with unexplained syncope at each participating site (the standard-care group). The primary outcome was the mean number of patient-reported episodes of syncope at 1 year. RESULTS: A total of 2234 patients underwent randomization: 1123 were assigned to the intervention group and 1111 to the standard-care group. The mean age of the patients was 58.3 years, and 52.1% were male. After the exclusion of patients who did not complete any follow-up, a total of 1970 patients (1004 in the intervention group and 966 in the standard-care group) were included in the primary analysis. The mean (±SD) number of patient-reported syncope episodes at 1 year was 1.37±5.10 in the intervention group and 1.58±8.56 in the standard-care group (incidence rate ratio, 0.89; 95% confidence interval, 0.68 to 1.18; P = 0.42). A total of 49 adverse events were reported in the intervention group, and 8 adverse events were reported in the standard-care group, with 1 serious adverse event in each group. CONCLUSIONS: Among patients with syncope that remained unexplained after evaluation in the emergency department, the use of 14-day ambulatory ECG monitoring did not result in significantly fewer patient-reported syncope episodes at 1 year than standard care. (Funded by the British Heart Foundation and National Health Service Research Scotland; ASPIRED ISRCTN Registry number, ISRCTN10278811.).

NEJMArticle

The New England journal of medicine

Targeted Use of Computed Tomographic Coronary Angiography in Acute Chest Pain.

BACKGROUND: Many patients with suspected acute coronary syndrome in whom myocardial infarction has been ruled out in the emergency department remain at risk for cardiovascular events. Whether further investigation reduces this risk is unknown. METHODS: In a multicenter, randomized, controlled trial, patients who presented to an emergency department in 14 hospitals across the United Kingdom were enrolled if myocardial infarction had been ruled out and high-sensitivity cardiac troponin testing indicated an intermediate risk of a cardiovascular event (maximum high-sensitivity cardiac troponin I or T concentration, >5 ng per liter). Participants were randomly assigned in a 1:1 ratio to receive either outpatient computed tomographic (CT) coronary angiography-guided care or standard care. The primary outcome was a composite of myocardial infarction or death from a cardiac cause. RESULTS: From September 18, 2019, to May 11, 2023, a total of 3170 participants (median age, 61 years; female sex, 30.2%) were assigned to undergo CT coronary angiography (1587 participants) or receive standard care (1583 participants). At 90 days after randomization, CT coronary angiography had been performed in 1462 participants (92.1%) in the CT coronary angiography group and in 35 participants (2.2%) in the standard-care group. Overall, 7 participants (0.4%) had a CT coronary angiography-related adverse event. After a median of 3.0 years, at which point the number of primary-outcome events in the standard-care group exceeded the prespecified minimum of 97, a primary-outcome event had occurred in 112 participants (7.1%) in the CT coronary angiography group and in 116 (7.3%) in the standard-care group (adjusted hazard ratio, 0.95; 95% confidence interval, 0.73 to 1.23; P = 0.71). CONCLUSIONS: In patients with suspected acute coronary syndrome in whom myocardial infarction had been ruled out, routine CT coronary angiography-guided management did not result in a lower incidence of subsequent myocardial infarction or death from a cardiac cause than standard care. (Funded by the British Heart Foundation; TARGET-CTCA ClinicalTrials.gov number, NCT03952351.).

JAMAArticle

JAMA

Arginine Therapy for Sickle Cell Disease Acute Pain Episodes: The STArT Randomized Clinical Trial.

IMPORTANCE: Acute pain episodes are the leading cause of emergency department visits and hospitalizations for patients with sickle cell disease (SCD), yet US Food and Drug Administration-approved drugs for acute pain episodes are lacking. During acute pain episodes, patients develop acute arginine deficiency associated with longer time to crisis resolution and greater total parenteral opioid use. Multiple single-center, phase 2 randomized clinical trials have shown that arginine is safe, is opioid sparing, improves cardiopulmonary function, and reduces length of hospital stay. OBJECTIVE: To determine the efficacy and safety of intravenous arginine for SCD acute pain episodes. DESIGN, SETTING, AND PARTICIPANTS: Prospective, phase 3, double-blind randomized clinical trial conducted between June 21, 2021, and June 13, 2024, in 10 US children's hospitals enrolling patients aged 3 to 21 years presenting to the emergency department with SCD acute pain episodes requiring parenteral opioids. INTERVENTIONS: Patients were randomized to receive intravenous arginine (200 mg/kg followed by 100 mg/kg every 8 hours until discharge; n = 129) or saline placebo (n = 142). MAIN OUTCOMES AND MEASURES: The primary outcome was time to crisis resolution, defined as hours from initial study drug delivery to last intravenous opioid dose. Secondary outcomes included total parenteral opioid use (intravenous morphine equivalents in milligrams per kilogram from first study drug dose to last intravenous opioid dose), pain scores, and patient-reported outcomes. RESULTS: Of 274 randomized participants, 271 received study drug; the mean age was 14.3 years (SD, 4.3 years), 51% were male, and 92% were Black. The trial was halted early for futility, as time to crisis resolution was similar in those receiving arginine vs placebo (median, 60.8 hours [IQR, 34.8-109.0 hours] vs 65.8 hours [IQR, 31.1-111.1 hours], respectively; absolute difference, 7.2 hours; 95% CI, -21.6 to 35.9 hours). No significant differences were seen in total parenteral opioid use, pain scores, patient-reported outcomes, or safety events. CONCLUSIONS AND RELEVANCE: Arginine therapy did not shorten time to crisis resolution compared with placebo among children and young adults with SCD acute pain episodes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04839354.

Nature MedicineArticle

Nature medicine

Prospective evaluation of a large language model clinical decision support system in the emergency department.

Prospective evidence for artificial intelligence (AI)-based clinical decision support in emergency departments remains limited. Here we conducted a DECIDE-AI stage 1 evaluation of SHAKED, a clinical decision support system built on multiple large language models, in a tertiary emergency department. Over 4 weeks, 1,138 patients were analyzed across two parallel units-one using SHAKED and one following routine rotations. Clinical adoption of SHAKED declined from 68% to 30%, owing to workload-sensitive disengagement (OR = 0.72 per shift hour, 95% CI 0.62 to 0.83). Physicians preferred the use of SHAKED for radiology consultations (OR = 2.98, 95% CI 1.58 to 5.63). No adverse events were detected, and expert review rated 99 of 100 sampled outputs as clinically appropriate. Emergency department length of stay did not differ between wings (4.9 h in both, P = 0.99). Intention-to-treat analysis showed a non-significant trend toward shorter consultation cycle time (-9.4 min, P = 0.077). These findings suggest that sustained clinician engagement, rather than algorithmic accuracy, may be the key barrier to effective clinical AI use in emergency departments. They inform randomized trial design but do not justify clinical deployment of AI clinical decision support at this stage. ClinicalTrials.gov identifier: NCT06902675 .

Annals EMGuideline

Annals of emergency medicine · ACEP

Unscheduled Procedural Sedation Multidisciplinary Delphi Consensus Guidelines, Part 1: Principles, Oversight, and Quality Monitoring: Approved by the ACEP Board of Directors, April 29, 2026.

Policy statements and clinical policies are the official policies of the American College of Emergency Physicians and, as such, are not subject to the same peer review process as articles appearing in the journal. Policy statements and clinical policies of ACEP do not necessarily reflect the policies and beliefs of Annals of Emergency Medicine and its editors.

Annals EMGuideline

Annals of emergency medicine · ACEP

Unscheduled Procedural Sedation Multidisciplinary Delphi Consensus Guidelines, Part 2: Clinical Practice: Approved by the ACEP Board of Directors, April 29, 2026.

Policy statements and clinical policies are the official policies of the American College of Emergency Physicians and, as such, are not subject to the same peer review process as articles appearing in the journal. Policy statements and clinical policies of ACEP do not necessarily reflect the policies and beliefs of Annals of Emergency Medicine and its editors.

Diabetes CareArticle

Diabetes care · ADA

Clinical Utility of a Type 1 Diabetes Genetic Risk Score Measured as Part of MODY Genetic Testing.

OBJECTIVE: To evaluate the clinical utility of incorporating a type 1 diabetes genetic risk score (T1DGRS) into monogenic diabetes gene panel testing for individuals referred for suspected maturity-onset diabetes of the young (MODY) from routine clinical practice. RESEARCH DESIGN AND METHODS: We studied 1,129 individuals treated with insulin referred for MODY genetic testing. All underwent gene panel testing that included 10 variants to calculate T1DGRS. We compared T1DGRS distributions with reference populations to estimate the T1D prevalence within referred individuals. We defined age-specific T1DGRS thresholds to identify probable T1D (positive predictive value ≥80%) and applied them in individuals genetically unsolved MODY to assess its utility as a pregenetic testing triage tool. RESULTS: T1DGRS in MODY referral individuals was intermediate between reference populations with and without T1D, consistent with an estimated 20% (95% CI 14.9-25.2%) T1D in this real-world setting. After genetic testing, no excess T1DGRS was observed in individuals with genetically solved MODY, whereas those with unsolved MODY showed enrichment consistent with 26.0% T1D, with highest values in children (76.2%) and lowest in adults (16.8%). Age-specific T1DGRS thresholds identified 16.1% (95% CI 13.8-18.5%) of genetically unsolved MODY as probable T1D. As a pretesting tool, T1DGRS showed limited discrimination overall (area under the curve [AUC] 0.60) but performed well in children aged <10 years (AUC 0.83), where >50% of tests could be avoided without missing MODY. CONCLUSIONS: Incorporating a T1DGRS into routine MODY gene panel testing is feasible and clinically valuable. This approach broadens genomic diagnostics beyond monogenic disease by identifying T1D in individuals with genetically unsolved MODY. Pregenetic testing utility is age dependent and may reduce unnecessary testing in pediatric patients.

Diabetes CareArticle

Diabetes care · ADA

Excess Burden of Inpatient Admissions and Emergency Department Visits Associated With Diabetes Across the Age Spectrum.

OBJECTIVE: The epidemiology of diabetes and its complications is changing due to increasingly younger ages of diagnosis and increased life expectancy. How this changing landscape affects health care use, and for which conditions, is unclear. We examined age-specific excess burdens of cause-specific inpatient and emergency department (ED) visits associated with diabetes. RESEARCH DESIGN AND METHODS: We used 2019 Behavioral Risk Factor Surveillance System, National Inpatient Sample, and Nationwide Emergency Department Sample data to derive national U.S. estimates of inpatient admissions and ED visits in adults with and without diabetes. Complications were categorized as traditional, conditions emerging as diabetes associated, or other conditions co-occurring with diabetes. We calculated age-standardized absolute risk differences (ARDs) in people with versus without diabetes to identify leading causes of diabetes-related hospital use by age and setting. RESULTS: Traditional complications were dominated by sepsis, cardiorenal disease, acute kidney failure, myocardial infarction, and stroke, with ARDs ranging from 296 to 2,623 per 100,000 people with diabetes. Emerging conditions included pneumonia, device- and procedure-related complications (ARD range 125-473), and schizoaffective or other mental health disorders in younger adults only (ARD range 80-312). Other conditions included respiratory and fluid/electrolyte disorders across all ages (ARD range 100-363), while digestive and urinary disorders were more prominent in older adults (ARD range 229-482). ED visits showed a similar pattern, with lower ARD than inpatient admissions (ARD range 101-707). CONCLUSIONS: Diabetes drives substantial, age-specific excess inpatient and ED use, increasingly due to nontraditional rather than classic vascular and renal complications.

AFPArticle

American family physician · AAFP

Evaluation of the Painful Eye.

Eye pain is a common presentation in outpatient, urgent care, and emergency settings. Causes range from benign to vision-threatening. Family physicians should promptly identify red-flag features that require urgent or emergent ophthalmology referral. A painful eye with vision loss, severe photophobia, proptosis, hyphema, or corneal ulceration is a medical emergency. Patient history should include onset, associated vision changes, contact lens use, trauma, chemical exposure, systemic symptoms, and rheumatologic disease. Physical examination should include evaluation of visual acuity (eg, using a Snellen or Rosenbaum chart), pupillary reactions, and extraocular movements. The eyes should be inspected for redness, discharge, and corneal lesions with fluorescein, if available. Findings of significant photophobia, anisocoria, dendritic corneal lesions, or restricted eye movement should prompt immediate referral. Common emergent causes of eye pain include acute angle-closure glaucoma, orbital cellulitis, infectious keratitis, scleritis, and anterior uveitis. An algorithmic approach that distinguishes urgent vs nonurgent etiologies and ophthalmic vs nonophthalmic causes of eye pain can direct next steps.

AFPArticle

American family physician · AAFP

Knee Pain in Adults and Adolescents: The Initial Evaluation.

Knee pain is common, with more than 30% to 45% of middle-aged and older adults having symptomatic osteoarthritis, and 25% to 40% of younger adults having patellofemoral pain syndrome. Components of a detailed history include time of onset; pain duration, quality, and localization; trauma/mechanism of injury; swelling; popping/clicking; aggravating and alleviating factors; sports activities; and limitations to current activity. The physical examination for evaluating knee pain involves five overall components: inspecting the joint for obvious abnormalities, palpating the joint to identify effusion or points of tenderness that may be the source of the pain; testing active and passive range of motion; testing strength; and performing specialized maneuvers that evaluate specific knee joint structures. These maneuvers are most accurate when performed in combination, rather than relying on one specific maneuver to make the diagnosis. In addition to these five examination components, imaging should be obtained if appropriate, with plain radiography typically being the first step. With traumatic injuries, clinical decision rules such as the Ottawa Knee Rule can determine if radiography is needed to detect fractures or other injuries that may require referral. Additional evaluations can include arthrocentesis when joint effusion is present, optimally guided by point-of-care ultrasonography when available, and laboratory testing if infection or inflammatory disorders are suspected.

JNCCNGuideline

Journal of the National Comprehensive Cancer Network : JNCCN · NCCN

NCCN Guidelines® Insights: Survivorship, Version 3.2026.

The NCCN Guidelines for Survivorship offer guidance for health care providers who care for survivors of adult-onset cancer. These guidelines include screening, evaluation, and treatment recommendations for common physical and psychosocial problems resulting from cancer and its treatment and provide a framework for care coordination. They also present guidance for helping cancer survivors to enhance their wellness and maintain a healthy lifestyle. This article summarizes the panel's current recommendations and recent updates regarding anxiety, depression, distress, and trauma in cancer survivors.

Oto-HNSArticle

Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · AAO-HNS

The Impact of COVID-19 Pandemic Response on Pediatric Mastoiditis-The Australian Experience.

OBJECTIVE: To assess the impact of COVID-19 pandemic response on the incidence and severity of pediatric mastoiditis in the Australian context. STUDY DESIGN: Retrospective case series. SETTING: Single tertiary pediatric referral hospital in Australia. METHODS: Retrospective review of pediatric patients (<18 years) admitted with acute mastoiditis (AM) from January 2012 to June 2025 was performed. Patients were categorized into time periods: pre-COVID, COVID, and post-COVID based on Australian health policy timelines. Baseline demographic and admission data were collected. The primary outcomes were AM incidence per emergency department (ED) admissions, mastoiditis complications and disease severity, surgical intervention and microbial spectrum. A subanalysis comparing prerestriction and postrestriction population was performed. RESULTS: 176 patients were assessed. AM incidence per ED admissions sharply increased in the post-COVID era and exceeded pre-COVID levels. The proportion of patients with intracranial complications increased sharply over time. Mastoidectomy rates doubled from 13.43% (pre-COVID) to 28.40% (post-COVID). Streptococcus anginosus was associated with 100% mastoidectomy rate and very severe disease (80%). Patients in the postrestriction period had 3 times greater risk of very severe disease compared to prerestriction: 18.4% vs 6.0%, RR, 3.07 (95% CI, 1.1-8.6), P = .03. CONCLUSION: An alarming increase in incidence and severity of pediatric AM in the postpandemic Australian population was identified. Vigilance of intracranial complications and rapid escalation of therapy are strongly recommended.

Diabetes CareArticle

Diabetes care · ADA

Adult Complications of Childhood-Onset Type 1 Diabetes Vary With Age at Diagnosis: A Population-Based Study.

OBJECTIVE: To examine incidence of long-term complications among people with childhood-onset type 1 diabetes, focusing on age at diabetes onset. RESEARCH DESIGN AND METHODS: A registry of children diagnosed with type 1 diabetes aged <16 years in New South Wales, Australia, between 1990 and 2009 linked to hospital, emergency department, public insurance, and death data from 2001 to 2019 to identify complications. Age at onset was categorized as <7 years, 7 to <13 years, and 13 to <16 years. Incidence rates and hazard ratios (HR), with 95% CI, for the risk of complications, were calculated from multivariable Cox regression models by 1) duration of diabetes 0 to <20 years and 2) attained age of 16-34 years, with HR adjusted for diagnosis year, sociodemographics, and acute diabetes complications. RESULTS: Of 5,202 people identified, 1,694 (32.6%) were diagnosed at age <7 years, 2,538 (48.8%) age 7 to <13 years, and 970 (18.6%) age 13 to <16 years. Within 20 years of onset, incidence ranged from 9.2 per 10,000 person-years (95% CI 7.2, 11.7) for cardiac complications to 53.4 per 10,000 person-years (95% CI 48.2, 59.0) for kidney complications. Diabetes onset at age <7 years (vs. 13 to <16 years) was associated with lower 20-year risk of complications, except lower-limb infections; cardiac adjusted HR (aHR) was 0.32 (95% CI 0.15, 0.66), severe retinopathy aHR was 0.25 (0.17, 0.36), lower-limb vascular complications aHR was 0.41 (0.24, 0.69), peripheral neuropathy aHR was 0.16 (0.08, 0.32), and kidney complications aHR was 0.40 (0.30, 0.53). Risk of complications did not differ by attained age. CONCLUSIONS: Children with type 1 diabetes onset at age <7 years had lower chronic complication risk in the first 20 years postdiagnosis, supporting a slower time to develop complications with prepubertal onset.

JAAOSArticle

The Journal of the American Academy of Orthopaedic Surgeons · AAOS

A Ten-year Review of Sex-based Representation at the Orthopaedic Trauma Association Annual Meeting.

BACKGROUND: Although female representation at national orthopaedic society meetings has increased in recent years, women remain disproportionately more likely to deliver nontechnical presentations. Examining patterns in speaker roles provides a measurable way to assess progress toward equitable representation by sex in academic orthopaedic settings. QUESTIONS/PURPOSES: This study aimed to (1) evaluate trends in female speaker representation at the Orthopaedic Trauma Association (OTA) Annual Meeting from 2014 to 2024 and (2) assess sex-based differences in speaker roles, including the likelihood of delivering technical versus nontechnical presentations. PATIENTS AND METHODS: Speaker names, session titles, and roles (speaker, moderator, or committee member) were extracted from OTA Annual Meeting programs spanning 2014 to 2024. Sessions were classified as technical or nontechnical, and speaker sex was determined through publicly available information. A total of 514 sessions were analyzed, including 390 technical and 124 nontechnical sessions. Trends in speaker roles by sex were assessed over time, and odds ratios (ORs) were calculated to evaluate the likelihood of men versus women delivering technical presentations. RESULTS: Female representation increased across all roles over the study period. The proportion of female speakers rose from 8.85% in 2014 to 22.22% in 2024, and the proportion of female moderators increased from 4.84% to 12.99%. Four women served as committee members since 2021, with one serving as cochair. Men were significantly more likely to give technical talks in 2024 (OR 2.8, 95% CI, 1.47-5.41, P = 0.0018) and 2021 (OR 3.0, 95% CI, 1.59-5.87, P = 0.0009). CONCLUSION: Female representation at the OTA Annual Meeting has increased substantially over the past decade, mirroring trends observed in other orthopaedic subspecialty societies. However, sex-based differences in the distribution of technical versus nontechnical presentations were observed in multiple years. Continued efforts are needed to promote equitable access to academic and leadership roles for women in orthopaedic trauma. LEVEL OF EVIDENCE: Level III (retrospective observational study).

JAAOSArticle

The Journal of the American Academy of Orthopaedic Surgeons · AAOS

Surgical Risk and Patient-Reported Outcomes in 3- and 4-Level Anterior Cervical Discectomy and Fusion: A Comparative Study.

INTRODUCTION: The existing literature on anterior cervical diskectomy and fusion (ACDF) predominantly focuses on 1- and 2-level procedures, leaving limited data comparing outcomes of 3- versus 4-level standalone ACDFs. Thus, the aim of this study was to compare surgical outcomes and patient-reported outcome measures (PROMs) of 3- versus 4-level ACDF. METHODS: Patients who underwent 3- or 4-level ACDF within a single academic health system (2014 to 2020) were retrospectively identified. Surgical outcomes and PROMs were evaluated, including the 0 to 10 numeric rating scale for neck and arm pain, Short Form-12, Modified Japanese Orthopaedic Association (mJOA), and Neck Disability Index (NDI). Patients were excluded if they did not have complete preoperative or 1-year postoperative mJOA scores, underwent ACDF for tumor/trauma/infection, or had concomitant posterior cervical fusion. RESULTS: A total of 256 patients were included (46 4-level ACDFs). Patients undergoing 4-level ACDF had higher BMI (30.8 vs. 28.9; P = 0.032) and a greater prevalence of myelopathy (45.7% vs. 33.3%; P = 0.018) but were otherwise demographically similar to 3-level ACDF patients. Four-level ACDF patients had a higher dysphagia rate (20% vs. 8.6%; P = 0.033) and a higher 30-day ED visit rate (6.5% vs. 0%; P = 0.005) but similar readmission rates and all other surgical outcomes. Patients with 4-level ACDF had better 6-month NDI scores but worse 1-year mJOA scores. All other PROM comparisons and deltas were similar at all time points. CONCLUSION: Patients undergoing 4-level ACDF had higher BMI and a greater prevalence of myelopathy than those undergoing 3-level ACDF; 4-level ACDF was associated with a higher rate of dysphagia and early postoperative ED utilization, but not readmissions. The groups otherwise did similarly with respect to surgical outcomes and PROM improvements. These findings suggest that extending fusion from three to four levels was not associated with increased surgical risk or inferior short-term functional or pain outcomes compared with 3-level ACDF.

JAMA Network OpenArticle

JAMA network open

An Electronic Health Record-Integrated, Large Language Model-Powered Tool to Triage Surgical Patients.

IMPORTANCE: Surgical comanagement (SCM) is an evidence-based care model in which hospitalists jointly manage medically complex perioperative patients alongside surgical teams. Despite its clinical and financial value, effective use of SCM is limited by the need to manually identify eligible patients; large language models (LLMs) are increasingly prevalent in clinical workflows and could be useful in selecting patients for SCM. OBJECTIVE: To assess whether SCM eligibility triage can be automated. DESIGN, SETTING, AND PARTICIPANTS: This prospective, unblinded quality improvement study was conducted at Stanford Health Care from September 2025 to February 2026. An LLM-based, electronic health record (EHR)-integrated, human-in-the-loop surgical triage tool (SCM Navigator) provided SCM triage recommendations, followed by physician review. All SCM attending physicians were invited to participate. EXPOSURE: Using preoperative documentation, structured data, and clinical criteria for perioperative morbidity, the tool categorized patients as appropriate, not appropriate, or possibly appropriate for SCM. SCM faculty indicated clinical judgment of SCM appropriateness and provided free-text feedback when they disagreed with the tool. MAIN OUTCOMES AND MEASURES: The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the tool were measured using physician feedback as a reference. Free-text reasons were thematically categorized. Manual medical record review was conducted on all false-negative cases. For the largest false-positive category, manual medical record reviews were conducted on 15 randomly selected cases subsequently seen by SCM and 15 randomly selected cases not seen by SCM. RESULTS: Overall, 14 of 16 SCM attending physicians participated in the study. Among 6193 triaged surgical cases (median [IQR] age, 60.2 [41.6-71.3] years; 3036 [49.0% female]), 1582 (25.5%) were recommended for hospitalist consultation. Using treating physicians' determinations as the reference standard, the tool had high sensitivity (0.94; 95% CI, 0.91-0.96) and moderate specificity (0.74; 95% CI, 0.71-0.77) for identifying patients appropriate for SCM. Post hoc medical record review suggested that most discrepancies reflected modifiable gaps in clinical criteria, institutional workflow, or physician practice variability rather than LLM misclassification, which accounted for 2 of 19 false-negative cases (11%). CONCLUSIONS AND RELEVANCE: In this prospective quality improvement study of an LLM-powered, EHR-integrated, human-in-the-loop AI system, AI-enabled screening tools accurately augmented surgical patient triage.

JAMA Network OpenRCT

JAMA network open

Bilevel Positive Airway Pressure and Continuous Albuterol for Pediatric Asthma Exacerbations: A Randomized Clinical Trial.

IMPORTANCE: A substantial knowledge gap remains in understanding the specific role bilevel positive airway pressure (BPAP) in the emergency department (ED) for acute pediatric asthma exacerbations. OBJECTIVE: To examine whether the early application of BPAP in the ED for acute pediatric asthma exacerbations reduces duration of critical care management time. DESIGN, SETTING, AND PARTICIPANTS: This double-blind randomized clinical trial enrolled children between 5 and 17 years of age presenting to a single-center, quaternary, referral pediatric ED with an acute asthma exacerbation, a pediatric respiratory assessment measure of at least 4 (moderate severity), and prescribed continuous albuterol therapy between June 1, 2023, and May 31, 2025. INTERVENTION: Participants were randomized to either the intervention arm (BPAP) or control arm (sham BPAP, which delivers minimal pressure) for 4 hours. Neither the health care practitioners nor participants were aware of study arm allocation. MAIN OUTCOME AND MEASURES: The primary outcome measure was duration of continuous albuterol therapy. A sequential design with a planned interim analysis for futility and superiority was used, and a t test compared mean duration of continuous β-agonist therapy under an intention-to-treat approach. RESULTS: Sixty-six study participants (median [IQR] age, 10.2 [6.8-13.2] years; 35 [53.0%] male; 1 [1.5%] American Indian or Alaskan, 1 [1.5%] Asian, 21 [31.8%] Black or African American, 21 [31.8%] White, and 22 [33.3%] other race) were included in the primary analysis, with a mean (SD) pediatric respiratory assessment measure of 5.2 (1.9), indicating moderate disease. At the 50% interim analysis, participants in the BPAP study arm received a mean (SD) of 8.3 (8.5) hours of continuous albuterol vs 8.7 (10.0) hours in the control group (mean difference, -0.5 hours; 95% CI, -5.0 to 4.1 hours; P = .84). The study was stopped due to meeting a priori bounds for futility at the 50% interim analysis. No deaths, invasive mechanical ventilation, air leak syndrome, or aspiration pneumonia were observed in either study arm. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of early initiation of BPAP in the ED, no clinically significant decrease in the duration of continuous β-agonist therapy in pediatric patients presenting with moderate asthma exacerbations was observed. Additional open-label studies in a more severe asthma cohort are required to better inform clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05848115.

JAMA Network OpenArticle

JAMA network open

Care Team Response to Patient Portal Message Content and Writing Style.

IMPORTANCE: Patient portal messages are an increasingly central channel for patient-clinician communication, but there are inequities in how responsive care teams are to messages sent by patients from historically marginalized groups. The reasons driving these disparities are not well understood. OBJECTIVE: To quantify factors that could potentially explain lower rates of care team response to messages sent by patients from historically marginalized groups. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used natural language processing to systematically extract message content and writing style features from portal message threads. Messages were from adult patients who sent a medical advice request message from January 1, 2021, to December 31, 2023, to a nontrainee physician, nurse practitioner, or physician assistant at a primary care practice. Data analysis was performed from May 2024 through June 2026. EXPOSURE: Message thread characteristics, including patient demographics, message content, and writing style. MAIN OUTCOMES AND MEASURES: Rates at which messages were responded to by care teams overall and by the message's originally intended target clinician specifically. Regression analysis quantified the degree to which message content and writing style potentially explain differences in care team response across patient groups. RESULTS: The sample included 3 619 390 patient message threads sent by 511 020 patients. Of the threads, 4.0% were sent by Asian patients, 3.7% by Black patients, 5.9% by Hispanic patients, and 83.0% by White patients. Messages sent by patients from historically marginalized groups (eg, Black and Hispanic patients, patients with only a high school education, and Medicaid beneficiaries) received lower levels of care team response. Compared with White patients, Black patients had a 3.7-percentage point (pp) (95% CI, -4.1 to -3.3 pp; P < .001) lower response rate from the target clinician, representing an 11.6% reduction. Although message content was associated with target clinician response, it could not explain these differences. On the contrary, writing style accounted for 48.0% of the difference for Black patients, 34.9% for Hispanic patients, 60.5% for patients with only a high school education (relative to patients with a college degree), and 42.8% for Medicaid patients (relative to commercially insured patients). CONCLUSIONS AND RELEVANCE: In this cross-sectional study of patient portal messages, writing style was a potential explanation for approximately half of the observed disparities in care team response, highlighting writing style as an important potential source of bias in message triage and a target for intervention.

JAMA Network OpenArticle

JAMA network open

Health and Health Care Access Among Afghan Refugee Women in the United States.

IMPORTANCE: Afghans are one of the world's largest refugee populations. Afghan women face compounded health risks due to sociocultural restrictions, low literacy, forced displacement, and limited health care access, yet little is known about their experiences with health care after resettlement in the US. OBJECTIVE: To explore health and health care access issues of Afghan refugee women in the US. DESIGN, SETTING, AND PARTICIPANTS: This qualitative study was part of an ongoing community-based participatory research project started in July 2020. Bilingual investigators conducted semistructured interviews with Afghan refugee women in Dari or English. Dari interviews were interpreted to English by a fluent bilingual investigator, validated by a separate bilingual investigator, and then reviewed with an Afghan immigrant community member for accuracy. Transcribed interviews were analyzed using grounded theory from July 2023 to July 2024. Participants who self-identified as Afghan, were born outside of the US, and were 18 years or older were recruited with convenience and purposive sampling from the San Francisco Bay Area of California through refugee-serving community organizations and word of mouth until data saturation was met. MAIN OUTCOMES AND MEASURES: Themes and subthemes about health and health care access. RESULTS: Of 23 Afghan women interviewed (median age, 30 years [range, 19-55 years]), most were married (22 [96%]) and had health insurance (16 [70%]). Their median time of residence in the US was 4 years (range, 1-17 years). Five key themes of health and health care access were identified: (1) health system barriers, such as inadequate interpretation causing miscommunication and mistrust, and insensitive health care including lack of informed consent; (2) sociocultural norms and women's autonomy, with patriarchal gender norms persisting after resettlement and limiting women's decision-making; (3) structural barriers resulting in the use of home remedies, driven by long wait times and negative prior experiences; (4) sociocultural barriers to sexual and reproductive health, with knowledge gaps shaped by intergenerational shame; and (5) mental health challenges, including widespread distress expressed through culturally specific idioms and somatic symptoms. CONCLUSIONS AND RELEVANCE: In this qualitative study, Afghan women described multilayered health care barriers, including displacement-related trauma, sociocultural norms, and structural deficiencies. Study findings suggest that culturally sensitive and linguistically appropriate public health interventions and structural changes are needed to improve health care access for Afghan women in the US.

JAMA Network OpenArticle

JAMA network open

Hospital-Onset Methicillin-Resistant Staphylococcus aureus Prevention in Acute Care Hospitals.

IMPORTANCE: Methicillin-resistant Staphylococcus aureus (MRSA) infections are major contributors to morbidity and mortality among hospitalized patients. Despite evidence-based guidelines, opportunities remain to improve the implementation of MRSA infection prevention. OBJECTIVE: To determine whether an educational quality improvement program is associated with improved evidence-based practices and prevention of MRSA infections among hospitalized patients. DESIGN, SETTING, AND PARTICIPANTS: This quality improvement study evaluates the Agency for Healthcare Research and Quality's Safety Program for MRSA Prevention, which was conducted and evaluated in volunteer intensive care units (ICUs) and non-ICUs in US acute care hospitals from April 2022 through September 2023. Data analysis, which was conducted between October 2024 and January 2025, compared data from the project period to the previous 12 months of baseline data. EXPOSURES: The program provided 22 webinars and durable educational content and assisted units with implementing evidence-based MRSA infection prevention interventions. Webinars targeted nurses, infection preventionists, physicians, nursing assistants, and environmental services personnel. The major foci were chlorhexidine bathing, nasal MRSA decolonization, environmental disinfection, and interventions to prevent person-based MRSA transmission and device-related infections. MAIN OUTCOMES AND MEASURES: The primary outcome was the rate of laboratory-identified, MRSA hospital-onset bacteremia (HOB) events. Secondary outcomes included hospital-onset clinical cultures growing MRSA, all-cause HOB, and central line-associated bloodstream infections. The χ2 test was used to compare binary outcomes. RESULTS: One hundred ninety-three hospital units completed the program (106 ICUs and 87 non-ICUs from 94 hospitals), including units from 31 (33%) academic medical centers, 42 (45%) non-academic medical centers teaching hospitals, and 21 (22%) nonteaching community or other hospitals. Between baseline and the end of the program, laboratory-identified MRSA HOB events decreased by -2.3 events per 10 000 patient-days (95% CI, -2.8 to -1.9 events per 10 000 patient-days; P < .001), or -65% (95% CI, -73% to -58%; P < .001). Clinical cultures growing MRSA from hospital day 4 or later decreased by -5.6 events per 10 000 patient-days (95% CI, -7.8 to -3.3 events per 10 000 patient-days; P < .001), or -39% (95% CI, -50% to -29%; P < .001). All-cause HOB decreased by -10.5 events per 10 000 patient-days (95% CI, -13.8 to -7.1 events per 10 000 patient-days; P < .001), or -37% (95% CI, -45% to -30%; P < .001). Central line-associated bloodstream infections decreased by -3.5 events per 10 000 central-line days (95% CI, -5.5 to -1.5 events per 10 000 central-line days; P < .001), or -31% (95% CI, -45% to -17%; P < .001). CONCLUSIONS AND RELEVANCE: In this quality improvement study of MRSA prevention in ICU and non-ICU hospital settings, the program was associated with significantly reduced rates of laboratory-identified MRSA HOB events and other infections among participating hospital units. The program content is publicly available and may help ICUs and non-ICUs reduce MRSA infection among hospitalized patients.

JAMA Network OpenArticle

JAMA network open

Hospital-Operated Medicare Advantage Plans and Care Utilization and Outcomes After Inpatient Admissions.

IMPORTANCE: Many health systems are integrating care delivery and financing by operating their own Medicare Advantage (MA) plans. Although these hospital-operated MA plans may improve care coordination and efficiency, their implications for care utilization and patient outcomes remain unclear. OBJECTIVE: To assess whether enrollment in hospital-operated MA plans is associated with differences in care utilization or health outcomes after major inpatient admissions. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used 2022 national Medicare data to compare 90-day care utilization and clinical outcomes after major inpatient admissions occurring between January 1, 2022, and September 30, 2022, among MA beneficiaries enrolled in hospital-operated MA plans vs other MA plans. Analyses adjusted for patient characteristics and county fixed effects, with inverse probability weighting to address potential patient selection. Data were analyzed from April 2025 to June 2026. EXPOSURE: Enrollment in hospital-operated MA plans. MAIN OUTCOMES AND MEASURES: Primary outcomes included rates of subsequent all-cause inpatient admissions, emergency department visits, observational stays, skilled nursing facility use, inpatient rehabilitation or long-term acute care use, length of subsequent inpatient and skilled nursing facility stays, mortality, and number of healthy days at home, all measured within 90 days of discharge. The secondary outcome was total episode spending, including spending during both the index admission and in the 90 days after discharge. RESULTS: The sample included 2278 MA plans offered in 2022, 332 (14.6%) of which were identified as hospital-operated MA plans. Across these plans, 468 441 major inpatient episodes related to 1 of 10 high-volume, high-cost medical or surgical conditions were identified, 75 662 (16.2%) of which were covered by hospital-operated MA plans. Compared with beneficiaries in other MA plans, hospital-operated MA plan enrollees were older, more often male and Hispanic, less likely to be non-Hispanic Black, and less likely to be dually eligible for Medicaid. After adjustment, hospital-operated MA plan enrollment was associated with lower rates of skilled nursing facility use (15.4% vs 18.3%; adjusted difference, -2.9 [95% CI, -3.2 to -2.6] percentage points [pp]) and observational stays (10.2% vs 11.6%; adjusted difference, -1.3 [95% CI, -1.6 to -1.1] pp) and higher rates of inpatient rehabilitation and/or long-term acute care services use (1.8% vs 1.0%; adjusted difference, 0.8 [95% CI, 0.8 to 0.9] pp) and readmissions (26.9% vs 25.0%; adjusted difference, 1.8 [95% CI, 1.5 to 2.1] pp), with no significant differences in emergency department visits. Despite these shifts in care utilization, hospital-operated MA plan enrollees experienced more healthy days at home (71.75 vs 71.52 days; adjusted difference, 0.23 [95% CI, 0.06 to 0.44] days) and no significant differences in mortality. Overall, hospital-operated MA plan enrollment was associated with lower episode spending ($24 072 vs $24 244; adjusted difference, -$172 [95% CI, -$291 to -$53]), with patterns broadly consistent across medical conditions and surgical procedures. CONCLUSIONS AND RELEVANCE: In this cross-sectional study of major inpatient episodes among MA beneficiaries, hospital-operated MA plan enrollment was associated with distinct post-acute care utilization patterns, lower episode spending, and no evidence of worse clinical outcomes. These findings suggest that vertical integration between health systems and health plans may be associated with more efficient and coordinated care delivery.

JAMA Network OpenArticle

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Implementation of Alternate Care Facilities During Public Health Emergencies: A Qualitative Study.

IMPORTANCE: Alternate care facilities (ACFs) have been used during public health emergencies in the US to expand surge capacity, yet little contemporary evidence synthesizes their operational challenges, successes, and alignment with national guidance. Understanding these experiences is essential to improving ACF planning and implementation. OBJECTIVES: To identify common successes, challenges, and best practices in planning and operating ACFs in the US, and to assess how these experiences can enhance national ACF resources. DESIGN, SETTING, AND PARTICIPANTS: This qualitative study included a literature review of US-based publications (from January 1, 1946, to December 31, 2024) describing ACF implementation during public health emergencies, as well as semistructured group interviews with subject matter experts (SMEs) with experience operationalizing ACFs. SMEs were identified from the literature and national networks and were required to have experience in planning or operating ACFs. Using convenience sampling, SMEs were invited to participate. Participants represented clinical, administrative, and emergency management backgrounds. The literature review and interviews were conducted from June to August 2024 without further follow-up. Data were analyzed using rapid qualitative methods with matrix-based thematic synthesis. MAIN OUTCOMES AND MEASURES: The primary outcome was identification of recurrent successes, challenges, and best practices for ACF planning and operations. Secondary outcomes included assessment of gaps in existing national guidance. RESULTS: A total of 30 SMEs were invited to participate; 16 clinicians and administrators accepted, composed of 11 men (68.8%) and 5 women (31.2%). The literature review identified 34 publications representing 19 ACFs across 14 states. Five themes emerged: (1) need for flexibility and adaptability; (2) importance of strong partnerships with health care systems, emergency management, and public health; (3) resource availability challenges; (4) need for executive leadership support; and (5) need for clear leadership structures. ACFs that affiliated with parent health systems, used flexible operational models, or implemented warm closure strategies (ie, allowing ACFs to maintain their footprint and reactivate as needed) demonstrated improved performance and community impact. CONCLUSIONS AND RELEVANCE: In this qualitative study of ACF experiences, consistent operational needs that extend beyond current national guidance were revealed. These findings suggest that incorporating experiential lessons related to flexibility, partnerships, resource readiness, executive support, and site leadership will strengthen future ACF planning, support more effective activation, and enhance national health care surge capacity during emergencies.

JAMA Network OpenArticle

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Long-Term Mortality and Quality of Life Among Adults With Mild Traumatic Brain Injury.

IMPORTANCE: Mild traumatic brain injuries (mTBIs) are the most common form of TBI and are responsible for 1.37 million years lived with disability annually, disproportionately affecting low- and middle-income countries (LMICs), as 90% of TBIs occur in LMICs. OBJECTIVE: To measure the long-term mortality (12 months), quality of life (QoL), and functional status of patients with mTBI in Pakistan. DESIGN, SETTING, AND PARTICIPANTS: This cohort study was an analysis of prospectively collected data of patients with mTBI from a trauma registry of all injured patients from 2 tertiary care centers in Karachi, Pakistan, from December 2021 to May 2024, who were followed up for 12 months. Participants were adult patients (aged >18 years) admitted with mTBI and enrolled in the registry with recorded outcomes at 1, 3, 6, and 12 months. EXPOSURE: Mild TBI (Glasgow Coma Scale [GCS] score of 13-15). MAIN OUTCOMES AND MEASURES: Long-term mortality (12-month cumulative and follow-up) was the primary outcome, and QoL was the secondary outcome. RESULTS: A total of 602 patients presented with mTBI. Most were aged 18 to 39 years (336 patients [55.8%]), were male (502 patients [83.4%]), and experienced mTBIs from road traffic collisions (427 patients [71.1%]), or falls (130 patients [21.6%]). Surgical interventions were performed in 176 cases (29.2%) and were associated with 51% lower odds of 1-month cumulative mortality (adjusted hazard ratio, 0.44; 95% CI, 0.21-0.87). The inpatient, cumulative 1-month, and 12-month mortality rates were 4.6%, 8.9%, and 13.6%, respectively. Patients with a GCS score of 13 (20.2%) and 14 (20.1%) had a higher 12-month mortality rate as compared with patients with a GCS score of 15 (8.3%). Of 345 patients with follow-up data at 1 year, 269 (78.0%) achieved complete independence by 1 year. The functional engagement domain showed the highest rate of recovery (318 patients [92.2%]), while the physical well-being and recovery domain had the lowest, with 286 (82.9%) experiencing disability, particularly those with a GCS score of 13 and 14; only 59 (17.1%) reported no physical disability at 12 months. CONCLUSION AND RELEVANCE: In this cohort study of patients with mTBI in Pakistan, 12-month mortality was approximately 2-fold higher in patients with a GCS score of 13 to 14 (20.2% and 20.1%) compared with a GCS score of 15 (8.3%), alongside persistently poorer quality of life in lower-GCS score groups throughout the recovery period.

JAMA Network OpenRCT

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Low-Dose Hydrocortisone and Cognition in Women With HIV: A Randomized Clinical Trial.

IMPORTANCE: Women with HIV experience high rates of trauma, chronic stress, and depression, which are linked to cognitive impairment. Dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, glucocorticoid receptor function, inflammation, and HIV persistence are candidate mechanisms, yet no interventions directly target these pathways. OBJECTIVES: To determine whether low-dose hydrocortisone (LDH), a pharmacologic modulator of HPA axis function, improves cognition in women with HIV and to examine neuroendocrine, immune, and HIV-related mechanisms underlying treatment effects. DESIGN, SETTING, AND PARTICIPANTS: This 2-phase, placebo-controlled randomized clinical trial was conducted at Johns Hopkins University between November 2017 and July 2023. Participants were randomized to 1 of 4 treatment sequences: Phase 1 was a double-blind, placebo-controlled crossover trial testing the immediate (30 minutes) and delayed (4 hours) cognitive effects of a single LDH dose. Phase 2 was a double-blind, placebo-controlled, 4-week trial of the effects of daily LDH compared with placebo on cognition and safety parameters. Participants were virally suppressed women aged 18 to 65 years with HIV and elevated self-reported stress, mood or anxiety disorder, or both and objective impairment in at least 1 cognitive domain. INTERVENTIONS: Single-dose LDH (10 mg orally; phase 1) or daily LDH (10 mg orally; phase 2) compared with placebo. MAIN OUTCOMES AND MEASURES: The primary outcomes were verbal learning and memory (assessed with the Hopkins Verbal Learning Test-Revised), working memory (assessed with the Letter-Number Sequencing task), and visuospatial abilities (assessed with the Repeatable Battery for the Assessment of Neuropsychological Status Line Orientation subtest). Secondary outcomes included additional cognitive domains (eg, attention and executive function), safety metrics, and mechanistic markers (eg, salivary cortisol, inflammatory biomarkers, glucocorticoid receptor function, and HIV reservoirs). RESULTS: Eighty-one women (mean [SD] age, 55.2 [8.0] years) were randomized. LDH produced a cortisol increase peaking 75 minutes post dose (Cohen d = 1.30; 95% CI, 1.00 to 1.60; P < .001). At 4 hours post dose, LDH significantly improved learning compared with placebo (Cohen d = 0.35; 95% CI, 0.02 to 0.69; P = .03), whereas the improvement in verbal delayed recall was not significant (Cohen d = 0.33; 95% CI, -0.01 to 0.67; P = .05). LDH improved attention at the 30-minute (Cohen d = 0.38; 95% CI, 0.04 to 0.71; P = .02) and 4-hour (Cohen d = 0.42; 95% CI, 0.08 to 0.76; P = .01) time points. LDH had no effect on working memory or visuospatial abilities. In phase 2, daily LDH, but not placebo, improved memory (Cohen d = 0.71; 95% CI, 0.22 to 1.20; P = .005), although the treatment × time interaction was not significant (Cohen d = 0.42; 95% CI, -0.25 to 1.08; P = .22). LDH was well tolerated. No associations were observed between LDH-related biomarkers and cognitive changes. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, LDH produced acute and short-term improvements in verbal learning, memory, and attention in virally suppressed women with HIV. These findings suggest that HPA axis modulation may represent a therapeutic pathway for cognitive dysfunction in HIV. Peripheral biomarkers did not account for these cognitive benefits, suggesting that other biological mechanisms may underlie LDH's effects. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03237689.

JAMA Network OpenArticle

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Medicare Shared Savings Program and Disparities for Patients With Low Income.

IMPORTANCE: Little is known about whether accountable care organizations (ACOs) in the Medicare Shared Savings Program (MSSP) have affected socioeconomic health care disparities. OBJECTIVE: To investigate whether attribution to an ACO was associated with greater improvement in outcomes for patients with low vs higher income. DESIGN, SETTING, AND PARTICIPANTS: This cohort study employed triple difference-in-differences analyses using 2010 to 2019 Medicare data to investigate whether quality differences between patients with low income and patients with higher income attributed to ACOs changed after ACO formation relative to patients at non-ACO practices or clinics. In exploratory analysis, we calculated 3-year outcomes (reflecting 1 ACO contract period) for each ACO and examined whether changes in disparities were associated with ACO characteristics such as size, rurality, inclusion of a hospital, share of patients with low income, presence of federally qualified health centers, and level of baseline disparities. Data analyses were performed between January 1, 2025, and February 27, 2026. EXPOSURE: Attribution to a medical practice or clinic in an ACO during the first 2 years of ACO tenure. MAIN OUTCOMES AND MEASURES: Differential changes in utilization-based quality metrics for patients with low vs higher income. Outcomes included potentially avoidable emergency department visits, ambulatory care-sensitive admissions, and 30-day unplanned hospital readmissions. RESULTS: There were 585 ACOs in the study. Three years after ACO formation, there was no differential change in outcomes for patients with low vs higher income at ACOs compared with non-ACOs. However, there was considerable variation; 76 ACOs (13.0%) were associated with reduced outcomes disparities in at least 1 quality measure while maintaining or improving quality for patients with higher income; 68 ACOs (11.6%) were associated with worsened outcomes disparities on at least 1 quality measure while maintaining or worsening quality for patients with higher income. ACOs that were associated with reduced disparities had a 0.36 (95% CI, 0.17-0.56; P < .001) higher SD-level z score of baseline disparities (eg, a 16.2% higher disparity in preventable emergency department visits) compared with ACOs that were associated with increased disparities but were similar on other characteristics. CONCLUSIONS AND RELEVANCE: In this cohort study of MSSP ACOs, ACO formation was not associated with reductions in income-based disparities in quality of care during the program's first decade. However, the differences in quality of care narrowed for patients with low vs higher income at a subset of ACOs.

JAMA Network OpenArticle

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Mental Health Service Use in Sexually and Gender Diverse Youths and Cisgender Heterosexual Youths.

IMPORTANCE: Sexually and gender diverse (SGD) youths experience disproportionate mental health challenges, yet longitudinal evidence of their mental health service use remains limited. OBJECTIVE: To examine mental health outpatient, emergency, and inpatient service use among SGD youths compared with cisgender heterosexual youths from preschool to young adulthood. DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study included 1326 participants from the Quebec Longitudinal Study of Child Development who self-reported sexual orientation and gender identity at age 23 years. Participants were followed up from birth (between October 1997 and July 1998). The wave of data collection when they were 23 years old occurred in June 2023. Data analyses were conducted between September 2024 and June 2026. EXPOSURE: Self-reported sexual and gender diversity at age 23 years. MAIN OUTCOMES AND MEASURES: Mental health outpatient (age 1-23 years; 1997-1998 to 2021), emergency (age 18-23 years; 2016 to 2021), and inpatient (age 8-23 years; 2006 to 2021) service use extracted from 3 provincial administrative health databases: the Régie de l'Assurance Maladie du Québec, the Banque de Données Communes des Urgences, and the Maintenance et Exploitation des Données pour l'Étude de la Clientèle Hospitalière. RESULTS: Of 1326 participants (691 [52.1%] assigned female at birth), 324 (24.4%) identified as sexually diverse and 32 (2.4%) identified as gender diverse. After controlling for sex assigned at birth and socioeconomic status, SGD youths were more likely than cisgender heterosexual youths to use outpatient services (adjusted odds ratio [AOR], 1.41 [95% CI, 1.09-1.83]) and emergency services (AOR, 1.99 [95% CI, 1.33-2.98]); the association was not present for inpatient services (AOR, 1.49 [95% CI, 0.87-2.54]). Growth curve models indicated a similar likelihood of outpatient service use between SGD youths and cisgender heterosexual youths in preschool, but steeper increases among SGD youths over time (b = 0.21 [SE, 0.11; 95% CI, -0.002 to 0.41]; P = .05]). SGD youths assigned female at birth had higher odds of emergency and inpatient service use compared with cisgender heterosexual females. SGD youths assigned male at birth had higher odds of outpatient service use compared with cisgender heterosexual males. CONCLUSIONS AND RELEVANCE: In this population-based cohort study, SGD youths showed greater use of mental health services across development, with disparities emerging early and widening over time. These findings highlight the need for early and sustained mental health support for SGD youths.

JAMA Network OpenArticle

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Methadone vs Buprenorphine-Naloxone in Opioid Overdose Survivors.

IMPORTANCE: Individuals who experience opioid overdoses are at high risk of death, and data are limited about the comparative effectiveness of medications for this high-risk population. OBJECTIVE: To compare the effectiveness of methadone and buprenorphine-naloxone in individuals with a past-year history of opioid overdose. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study with target trial emulation included individuals who started methadone or buprenorphine-naloxone treatment between January 1, 2017, and December 31, 2023, in Ontario, Canada. Participants had a past-year emergency department visit for an opioid overdose and no use of either medication for 7 days. Individuals starting each medication were matched on a 1:1 basis using propensity scores, sex, and index date. Data were analyzed from November 2024 to June 2026. MAIN OUTCOMES AND MEASURES: The primary outcome was death from any cause within 1 year, analyzed using an initiator approach with Cox proportional hazards regression. The secondary outcomes were opioid overdose and treatment discontinuation. Per-protocol analyses evaluating outcomes before medication discontinuation were also conducted. RESULTS: A total of 5882 individuals were included in the matched cohort (mean [SD] age, 35.8 [10.8] years; 1888 female [32.1%]). In the methadone-initiating group, 165 individuals (5.6%) died within 1 year, compared with 210 (7.1%) in the buprenorphine-naloxone-initiating group (HR, 0.78; 95% CI, 0.63-0.95; P = .01), with an E-value of 1.9. Median time to treatment discontinuation was 25 days (IQR, 7-131 days) in the methadone group compared with 16 days (IQR, 5-69 days) in the buprenorphine-naloxone group (HR, 0.78; 95% CI, 0.74-0.82; P < .001). There was no significant difference in the time to first opioid overdose (HR, 1.07; 95% CI, 0.97-1.18; P = .17). In the per-protocol analyses, there was no significant difference in the hazard of death among individuals starting methadone and buprenorphine-naloxone (HR, 0.84; 95% CI, 0.48-1.47; P = .55) and an increased hazard of opioid overdose among individuals starting methadone (HR, 1.52; 95% CI, 1.19-1.93; P < .001). CONCLUSIONS AND RELEVANCE: In this matched cohort of individuals with a past-year opioid overdose, starting methadone was associated with a reduced risk of death during the subsequent year compared with starting buprenorphine-naloxone. Treatment durations were short, particularly among individuals starting buprenorphine-naloxone, and there was no significant difference in mortality during receipt of opioid agonist treatment. These findings may be explained by unmeasured confounding, and epidemiologic studies in other jurisdictions are needed to confirm these findings.

JAMA Network OpenArticle

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Outcomes of Moderate-to-Severe Traumatic Brain Injury in a Low-Resource Setting.

IMPORTANCE: No study from a low- and middle-income country (LMIC) has reported long-term mortality and quality of life (QOL) after moderate to severe traumatic brain injury (msTBI), highlighting its burden and recovery trajectories. OBJECTIVES: To measure short- and long-term mortality and QOL among patients in an LMIC with msTBI and to identify factors associated with outcomes. DESIGN, SETTING, AND PARTICIPANTS: This cohort study analyzed prospectively collected data of patients with msTBI from December 1, 2021, to May 31, 2024, from a multicenter trauma registry of all injured patients from 2 tertiary care centers in Karachi, Pakistan. Adult patients (aged ≥18 years) with a diagnosis of msTBI (Glasgow Coma Scale [GCS] score of ≤12) enrolled in the registry and had recorded outcomes at 1, 3, 6, and 12 months. EXPOSURE: Moderate TBI (GCS score of 9-12) or severe TBI (GCS score ≤8 or intubated patients with recorded GCS). MAIN OUTCOMES AND MEASURES: The primary outcome was mortality (inpatient, follow-up, and cumulative), and the secondary outcome was QOL. RESULTS: Of the 819 patients (median age, 38 years [IQR, 26-54 years]; 689 men [84.1%]), 368 (44.9%) had moderate TBI and 451 (55.1%) had severe TBI; 158 patients (19.3%) were lost to follow-up at 12 months. Road traffic crashes were the most common cause of TBI (607 [74.1%]). Inpatient mortality was 22.9% among patients with moderate TBI (80 of 349) and 68.9% among those with severe TBI (295 of 428). For patients discharged alive, 8.2% with moderate TBI (30 of 368) and 5.8% with severe TBI (26 of 451) died within 1 month. Cumulative mortality at 12 months was 59.4% among patients with moderate TBI and 87.8% among those with severe TBI. Older age (adjusted hazard ratio [AHR], 1.01 [95% CI, 1.01-1.02] per additional year of age), TBI severity (AHR, 2.67 [95% CI, 2.24-3.18]), and having no surgical intervention (AHR, 1.43 [95% CI, 1.18-1.74]) were significantly associated with higher 12-month mortality. Patients with severe TBI had poor QOL reported across all domains compared with those with moderate TBI. CONCLUSIONS AND RELEVANCE: In this cohort study of patients in Pakistan with msTBI, mortality was high, particularly among those with severe TBI, and most posthospital deaths occurred within the first month after hospital discharge. Older age, no surgical intervention, and greater injury severity were associated with higher mortality, highlighting the need for improved acute and postdischarge care in resource-limited settings.

JAMA Network OpenArticle

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Probiotic Implementation and Necrotizing Enterocolitis Risk in Preterm Infants.

IMPORTANCE: Despite their widespread use, uncertainty remains about the effectiveness and safety of probiotics for preventing necrotizing enterocolitis (NEC) in preterm infants. Recent regulatory warnings, including from the US Food and Drug Administration, have further emphasized the need for robust clinical data on both the benefits and risks of probiotics for this population. OBJECTIVE: To evaluate the association between implementation of a multistrain probiotic formulation and NEC incidence in preterm infants in a high-risk neonatal intensive care unit (NICU) setting. DESIGN, SETTING, AND PARTICIPANTS: This multicenter retrospective cohort study was conducted at 2 NICUs in the Netherlands. Preterm infants (<30 weeks of gestational age [GA], birth weight [BW] <1000 g, or both) born between January 1, 2018, and July 1, 2024, were compared before and after the implementation of routine probiotic supplementation. The probiotic protocol was introduced in October 2020 or March 2021, depending on the center. EXPOSURE: Routine implementation of a multistrain probiotic formulation (Bifidobacterium infantis Bb-02, Bifidobacterium lactis BB-12, and Streptococcus thermophilus TH-4) as part of enteral feeding. MAIN OUTCOMES AND MEASURES: The primary outcome was NEC incidence, classified as medical, surgical, or fatal. Secondary outcomes included all-cause mortality and mortality not associated with NEC. Primary and secondary outcomes were analyzed using generalized linear regression models, comparing preimplementation and postimplementation periods and adjusting for GA, sex, BW z score, 5-minute Apgar score, prenatal steroid use, and preterm premature rupture of membranes. Interrupted time-series analysis was performed as a sensitivity analysis to assess robustness against underlying temporal trends. Probiotic-related sepsis was monitored to assess safety. RESULTS: This study included 1413 infants (742 males [52.5%]), stratified into a preimplementation group (n = 598) and a postimplementation group (n = 815). Baseline characteristics were comparable between groups (median GA, 27.7 weeks [IQR, 26.0-29.0 weeks] and 27.9 weeks [IQR, 26.4-29.0 weeks]; median BW, 950 g [IQR, 770-1170 g] and 975 g [IQR, 790-1190 g]). Following probiotic implementation, NEC incidence decreased from 11.9% (n = 71) to 5.3% (n = 43) (adjusted risk ratio [ARR], 0.49 [95% CI, 0.34-0.70]; P < .001). No statistically significant evidence of underlying time trends was detected. All-cause mortality remained stable for the preimplementation and postimplementation groups (70 [11.7%] vs 94 [11.5%]; ARR, 1.06 [95% CI, 0.82-1.39]; P = .64); non-NEC-associated mortality increased from 7.2% (n = 43) to 9.6% (n = 78) (ARR, 1.42 [95% CI, 1.01-1.98]; P = .04). One case of probiotic-associated sepsis was identified. CONCLUSIONS AND RELEVANCE: In this cohort study of preterm infants, implementation of a well-characterized multistrain probiotic was associated with a reduction in NEC incidence. This finding supports the use of the studied probiotic as an effective preventive strategy for NEC, although its effects on broader mortality outcomes remain uncertain.

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Reliability of Physical Examination Findings in Youths Diagnosed With Pneumonia.

IMPORTANCE: Community-acquired pneumonia (CAP) accounts for nearly 2 million pediatric outpatient and 375 000 emergency department (ED) visits annually in the US. Guidelines recommend relying on physical examination findings, not imaging, to diagnose CAP in youths who can be treated as outpatients. OBJECTIVE: To determine the interrater reliability (IRR) of physical examination findings in youths diagnosed with CAP in EDs. DESIGN, SETTING, AND PARTICIPANTS: This was a planned analysis from an ongoing prospective cohort study (pediatric CAP severity [PedCAPS]). Youths aged 3 months to 17 years with CAP were recruited at 7 academic pediatric EDs within the US from August 1, 2023, until May 24, 2025; participants had signs of lower respiratory tract infections, fever within 48 hours, and pneumonia on chest radiography, if performed. Youths with chronic pulmonary diseases (except asthma), sickle cell disease, immunodeficiency, cardiac disease, neurological disorders affecting respiration, and aspiration pneumonia were excluded, as were those hospitalized within the preceding 30 days or transferred from other EDs or hospitals. MAIN OUTCOMES AND MEASURES: Two examiners evaluated the same patient within 60 minutes of each other and independently recorded their findings. IRR of physical examination findings was reported by raw agreement and Fleiss κ. A lower bound of the 95% CI of 0.4 for κ was considered acceptable reliability. RESULTS: Among 252 youths with paired physical examinations (median [IQR] age, 5.7 [3.4-8.8] years; 127 female [50.4%]), the most frequent comorbidity was asthma (56 youths [22.2%]). In the overall study population, no physical examination finding met predefined significance for IRR. Wheezing (κ = 0.50; 95% CI, 0.39-0.62) and retractions (κ = 0.49; 95% CI, 0.37-0.60) had the highest IRR. In subanalyses of 124 youths discharged home and 128 youths who were hospitalized, IRRs of physical examinations were similar between the 2 groups. CONCLUSIONS AND RELEVANCE: In this study, individual auscultation findings, such as decreased breath sounds, crackles, or rhonchi, did not demonstrate sufficient reliability to be used alone for diagnosis.

CochraneSystematic review

The Cochrane database of systematic reviews · Cochrane

Psychological and psychosocial interventions for trauma-related psychological distress in adults living in ongoing conflict.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the relative benefit and harms of different psychotherapeutic or psychosocial interventions for trauma-related psychological distress in adults affected by ongoing conflict.

CochraneSystematic review

The Cochrane database of systematic reviews · Cochrane

Albumin for people with liver cirrhosis and bacterial infections.

RATIONALE: People with liver cirrhosis are at an increased risk of bacterial infections, with a high rate of complications and mortality. Adding albumin to antibiotics may reduce their occurrence. OBJECTIVES: To assess the benefits and harms of intravenous administration of human albumin in people with liver cirrhosis and bacterial infections versus no intervention, placebo, or other intravenous fluids. SEARCH METHODS: We identified randomised clinical trials (RCTs) through electronic searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index-Science. We searched online clinical trial registries for unpublished or ongoing trials and checked reference lists for additional trials (latest search date: 20 August 2025). ELIGIBILITY CRITERIA: RCTs comparing albumin versus no intervention, placebo, or other intravenous fluids, in people with infection in cirrhosis. OUTCOMES: Critical outcomes: all-cause mortality, serious adverse events, and health-related quality of life. Among the important outcomes were kidney impairment, acute liver decompensation, acute-on-chronic liver failure, and septic shock. RISK OF BIAS: We used the Cochrane risk of bias (RoB) 2 tool. SYNTHESIS METHODS: We used standard Cochrane methods. We meta-analysed outcome data at the longest follow-up. We presented dichotomous outcomes as risk ratios (RR) or odds ratios (OR), with 95% confidence intervals (CI), and a random-effects model. We assessed the certainty of evidence with GRADE. We used 0.25 minimal important difference and optimal information size to assess imprecision. INCLUDED STUDIES: We included 11 parallel-group RCTs (published between 1999 and 2022), with 1273 adults with cirrhosis and bacterial infections. One trial was a multicentre trial conducted in eight European countries, and ten were conducted in India, Spain, China, France, Egypt, and Taiwan. The trials' settings were clinics or university hospitals. Trial participants had spontaneous bacterial peritonitis (n = 388; five trials), infections other than spontaneous bacterial peritonitis (n = 477; four trials), and infections in different sites and sepsis-induced hypotension (n = 408; two trials). Intravenous albumin was compared with no intervention (eight trials) and other intravenous fluids such as plasmalyte, normal saline, or hydroxyethyl starch (three trials). All participants received antibiotics. The follow-up was four to 90 days. All trials provided data for intention-to-treat analysis. SYNTHESIS OF RESULTS: Below, we present only the outcome results displayed in our Summary of Findings tables. Risk of bias For overall risk of bias, most of the outcomes had some concerns or a high risk of bias. This was due to missing information regarding the randomisation process, deviations from the intended interventions, missing outcome data, measurement of the outcome, or bias in the selection of the reported result. GRADE We downgraded the evidence to low or very low due to risk of bias and imprecision, meaning that the evidence was either uncertain or very uncertain. This was mainly due to a high or unclear risk of bias or due to imprecision (wide confidence intervals crossing thresholds of interest, or optimal information size not reached). Albumin versus no intervention There may be little to no difference between albumin and no intervention regarding all-cause mortality (RR 0.80, 95% CI 0.53 to 1.20; I² = 45%; 8 studies, 845 participants; very low-certainty evidence), but the evidence is very uncertain. The evidence is also very uncertain about the effect of albumin on serious adverse events (RR 3.15, 95% CI 0.39 to 25.15; I² = 21%; 3 studies, 411 participants; very low-certainty evidence) and about whether it may reduce the risk of kidney impairment (RR 0.51, 95% CI 0.28 to 0.93; I² = 45%; 7 studies, 768 participants; very low-certainty evidence). The evidence is either uncertain or very uncertain about the effect of albumin on acute liver decompensation (RR 1.87, 95% CI 0.36 to 9.81; I² not applicable; 1 study, 118 participants; very low-certainty evidence), on acute-on-chronic liver failure (RR 0.86, 95% CI 0.43 to 1.73; I² not applicable; 1 study, 118 participants; low-certainty evidence), and on septic shock (RR 1.07, 95% CI 0.41 to 2.76; I² not applicable; 1 study, 118 participants; low-certainty evidence). Albumin versus other intravenous fluids The evidence is very uncertain about the effect of albumin on all-cause mortality (RR 1.05, 95% CI 0.85 to 1.29; I² = 0%; 3 studies, 428 participants; very low-certainty evidence). Albumin may increase serious adverse events (Peto OR 9.25, 95% CI 2.66 to 32.18; I² not applicable; 2 studies, 408 participants; very low-certainty evidence), but the evidence is very uncertain. There may be little to no difference between albumin versus other intravenous fluids for kidney impairment (RR 0.77, 95% CI 0.53 to 1.10; I² = 0%; 2 studies, 120 participants; very low-certainty evidence), but the evidence is very uncertain. Albumin may reduce the risk of septic shock (RR 0.91, 95% CI 0.85 to 0.97; I² = 0%; 2 studies, 408 participants; low-certainty evidence), but the evidence is uncertain. No trial reported data on quality of life, acute liver decompensation, or on acute-on-chronic liver failure. Seven trials were without for-profit support, one trial declared partial private funding, and three trials did not declare sources of support. We identified three ongoing trials. AUTHORS' CONCLUSIONS: Due to the very low certainty and low certainty of evidence, we are either uncertain or very uncertain about the effect of albumin, compared with no intervention, on all-cause mortality, serious adverse events, kidney impairment, acute liver decompensation, acute-on-chronic liver failure, and septic shock. Due to very low certainty of evidence, we are very uncertain about the effect of albumin, compared with other intravenous fluids, on all-cause mortality or kidney impairment. The evidence is also very uncertain whether albumin increases serious adverse events. Due to low-certainty evidence, we are uncertain whether albumin reduces septic shock. No trial in this comparison reported data on acute liver decompensation and acute-on-chronic liver failure. Data on health-related quality of life were lacking. Though clinically relevant, we could not assess the effect of albumin in regard to the site and stage of infection due to insufficient data. We lack trials in children. FUNDING: None. REGISTRATION: Protocol available via 10.1002/14651858.CD014636.

Diabetes CareArticle

Diabetes care · ADA

Emergency Hospitalization, Amputation, and Survival After Charcot Neuro-Osteoarthropathy Diagnosis in People With Diabetes: A Regional Registry-Based Cohort Study.

OBJECTIVE: The aim for this study was to describe adverse outcomes after Charcot neuro-osteoarthropathy (CNO) diagnosis in adults with diabetes and examine variation by clinical and sociodemographic characteristics. RESEARCH DESIGN AND METHODS: A regional, registry-based cohort study was conducted using linked routinely collected health care data from adults with diabetes and a first recorded CNO diagnosis in the National Health Service Greater Glasgow and Clyde, Scotland (2015-2024). Outcomes were all-cause emergency hospitalization, lower-extremity amputation, all-cause mortality, and amputation-free survival. Time-to-event methods and multivariable regression were used to estimate event probabilities and tested associations with clinical characteristics. RESULTS: From 127,513 adults with diabetes, 140 individuals with a first recorded CNO diagnosis were identified; their mean age was 59 years, and 67% were men. During a median 4.6-year follow-up, 123 patients (87.9%) had an emergency admission, 44 (31.4%) underwent lower-extremity amputation (minor or major), and 53 (37.9%) died. The estimated 5-year survival was 67%, while 5-year amputation-free survival was 44% (median 4.04 years). Advanced chronic kidney disease (stages 4 and 5) was associated with higher risk across outcomes. High or active foot-risk status was independently associated with lower-extremity amputation (subdistribution hazard ratio 8.52; 95% CI 2.05-35.45) and shorter amputation-free survival (hazard ratio (HR) 2.09; 95% CI 1.15-3.80), and older age was independently associated with higher mortality rate (HR 3.04; 95% CI 1.50-6.16). CONCLUSIONS: Adverse outcomes in CNO were frequent and occurred early after diagnosis, with high rates of emergency hospitalization, amputation, and death. These findings support CNO as a marker of systemic vulnerability and highlight the need for prioritized surveillance and multidisciplinary management in routine clinical care.

Nature MedicineRCT

Nature medicine

Maternal 6-valent group B Streptococcus vaccine in non-pregnant and pregnant females: a randomized phase 1/2 trial.

Group B Streptococcus (GBS) disease is a major cause of infant morbidity and mortality. Capsular polysaccharide conjugate GBS vaccines have been evaluated for decades; however, none is licensed. This phase 1/2 trial evaluated an investigational maternal hexavalent polysaccharide-protein conjugate GBS vaccine (GBS6) in non-pregnant females and pregnant participants and their infants. In stage 1 (conducted in South Africa), healthy non-pregnant participants received GBS6, GBS6 + aluminum phosphate (AlPO) or placebo; a subset received GBS6 + AlPObooster approximately 2 years later. Stage 2 (conducted in South Africa) maternal dose-finding data were reported previously and are not presented here. In stage 3, healthy pregnant participants from South Africa, the United States and the United Kingdom received GBS6 or placebo (24-36 weeks' gestation). In stage 1, 66 non-pregnant participants received GBS6, GBS6 + AlPOor placebo (n = 22 each); 26 also received GBS6 + AlPObooster. In stage 3, 216 pregnant participants were included (GBS6, n = 108; placebo, n = 108); 209 infants were born to maternal participants (GBS6, n = 104; placebo, n = 105). Primary objectives described GBS6 safety/tolerability profiles. Nearly all reactogenicity events were mild or moderate. Among non-pregnant participants, no serious adverse events (SAEs) or adverse event (AE)-associated withdrawals were reported after vaccination; medically attended adverse events (MAEs) were reported in similar percentages across primary vaccination groups (GBS6 groups = 41-45%; placebo = 41%). Rates of AEs (GBS6 = 75/108 (69%); placebo = 70/108 (65%)), SAEs (GBS6 = 21/108 (19%); placebo = 23/108 (21%)) and delivery outcome frequencies were similar in GBS6 and placebo maternal participants. Most infants were born full-term. Infant AE (GBS6 = 87/104 (84%); placebo = 86/105 (82%)), SAE (GBS6 = 45/104 (43%); placebo = 46/105 (44%)) and MAE (GBS6 = 65/104 (63%); placebo = 66/105 (63%)) frequencies were similar across groups. Two neonatal sepsis-associated deaths occurred (GBS6 = 1; placebo = 1); neither was considered vaccine related. Secondary objectives described immune responses. GBS6 elicited robust immune responses in non-pregnant and pregnant individuals; additionally, serotype-specific quantitative and functional antibody responses were observed in infants whose parent received GBS6. These data support continuing clinical investigation of maternal GBS6 vaccination. ClinicalTrials.gov identifier: NCT03765073 .

JACCArticle

Journal of the American College of Cardiology · ACC

Bivalirudin Versus Heparin in Low and Non-Low Bleeding Risk Patients Undergoing Primary PCI for STEMI: The BRIGHT-4 Trial.

BACKGROUND: In the BRIGHT-4 trial, among 6,016 patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with a radial artery approach, procedural anticoagulation with bivalirudin plus a post-PCI high-dose infusion for 2 to 4 hours reduced the 30-day primary composite outcome of all-cause death or Bleeding Academic Research Consortium (BARC) types 3 to 5 bleeding, as well as death and bleeding individually, compared with heparin monotherapy. OBJECTIVES: We sought to determine whether the benefits of bivalirudin apply principally to patients who are at low bleeding risk (LBR) as well as non-LBR. METHODS: In a prespecified analysis from BRIGHT-4, outcomes were examined by baseline bleeding risk, with LBR defined as a CRUSADE score <30. RESULTS: At baseline, 4,581 patients (76.1%) were categorized as LBR. Non-LBR patients had higher rates of the 30-day primary endpoint (8.6% vs 2.2%; HR: 4.08 [95% CI: 3.14-5.31]; P < 0.0001), driven by both greater mortality and BARC types 3 to 5 bleeding. In non-LBR patients, the primary outcome occurred in 8.1% of patients randomized to bivalirudin vs 9.2% of those randomized to heparin (difference: -1.1% [95% CI: -4.0% to 1.8%]; HR: 0.88 [95% CI: 0.62-1.26]). In LBR patients, the primary outcome occurred in 1.4% of patients randomized to bivalirudin vs 2.9% of those randomized to heparin (difference: -1.5% [95% CI: -2.3% to -0.6%]; HR: 0.49 [95% CI: 0.32-0.75]) (P= 0.81; P= 0.04). The effects of bivalirudin compared with heparin in reducing all-cause death were as robust in LBR patients compared with non-LBR patients (P= 0.67; P= 0.06). CONCLUSIONS: Among patients with STEMI undergoing primary PCI with radial artery access, procedural anticoagulation with bivalirudin plus a high-dose post-PCI infusion for 2 to 4 hours reduced the 30-day risk of all-cause death and major bleeding in patients at low bleeding risk as well as in patients at higher-risk of bleeding. (Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI [BRIGHT-4; NCT03822975]).

Nature MedicineArticle

Nature medicine

FcRH5×CD3 bispecific antibody cevostamab in relapsed or refractory multiple myeloma: a phase 1 trial.

Fc receptor-homolog 5 (FcRH5) is a membrane protein that is ubiquitously expressed on myeloma cells. Cevostamab is a first-in-class, FcRH5×CD3 bispecific antibody. GO39775 is a phase 1 dose-escalation and dose-expansion study evaluating fixed-duration cevostamab in relapsed or refractory multiple myeloma. Cevostamab was initiated with step-up dosing and continued at the target dose (TD) once every 3 weeks for 17 cycles (~12 months) unless disease progression or unacceptable toxicity occurred. Primary objectives were to evaluate safety, including determination of the maximum tolerated dose (MTD), and to identify a recommended phase 2 dose and schedule (RP2D) for cevostamab monotherapy. Secondary objectives included determining the rate of response and the duration of response (DOR). As of 24 February 2025, 324 patients had been enrolled; most were heavily pretreated (median prior lines, 6; triple-class refractory, 89.5% (290/324); prior B-cell maturation antigen (BCMA)-targeted therapy, 47.5% (154/324)). The MTD was not reached. Across all TD levels (0.15-252 mg), grade 3 or 4 adverse events (AEs) and serious AEs occurred in 59.6% (193/324) and 60.2% (195/324), respectively. Grade 5 AEs excluding disease progression occurred in 4.6% (15/324); 0.9% (3/324) were considered treatment related (hemophagocytic lymphohistiocytosis, n = 2; disseminated intravascular coagulation in the context of pseudomonal sepsis, n = 1). Objective response and very good partial response or better rates were 42.1% (136/323) and 25.1% (81/323), respectively. Median DOR was 11.2 months (95% confidence interval, 8.3, 15.6). A total of 167 patients received treatment at the 160 mg TD level (RP2D). Objective response and very good partial response or better rates were 44.3% (74/167) and 25.7% (43/167) in all patients and 60.6% (43/71) and 39.4% (28/71) in the BCMA naive, respectively. Median DOR was 10.4 months in all patients and 19.7 months in the BCMA naive, with durable responses maintained after the completion of treatment. Cytokine release syndrome was grade 1 or 2 in the 0.3/1.2/3.6/160 mg triple step-up cohort (RP2D). Cevostamab had manageable safety and induced durable remissions in late-line relapsed or refractory multiple myeloma. ClinicalTrials.gov registration: NCT03275103 .

Annals EMArticle

Annals of emergency medicine · ACEP

American Board of Emergency Medicine Report on Residency and Fellowship Training Information (2025-2026).

The American Board of Emergency Medicine gathers extensive background information on Accreditation Council for Graduate Medical Education-accredited emergency medicine residency and fellowship programs, as well as the residents and fellows training in those programs. We present the 2026 annual report on the status of physicians training in Accreditation Council for Graduate Medical Education-accredited emergency medicine training programs in the United States.

Trials

Showing 12 of 958 matching trials (5527 indexed).

TrialRECRUITINGNA

NCT06537609

A Platform Trial for Gram Negative Bloodstream Infections

BALANCE+ is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections (GN BSIs). Each domain addresses critical questions in the management of GN BSIs, aiming to refine treatment strategies, enhance patient outcomes, and reduce antimicrobial resistance. The initial vanguard pilot RCT (NCT05893147) started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024. All patients enrolled in the vanguard phase are part of the main platform trial.

Gram-negative Bacteremia

TrialRECRUITINGPHASE4

NCT07489274

Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).

Necrotizing soft-tissue infection (NSTI) is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The NSTI mortality rate remain high and largely unaltered in the last decades. The standard of care in NSTI is multidisciplinary and includes surgery, intensive care, and broad-spectrum antibiotics. Hyperbaric oxygen (HBO2) treatment is an adjunctive treatment potentially improving survival, but is not standard of care in many centres, presumably as no evidence of its benefit from randomized clinical trial exists. The primary objective of this trial, HOT-NSTI, is to investigate the effect of adjunctive HBO2 treatment on 30-day all-cause mortality in patients with NSTI.

Necrotizing Soft Tissue Infection

TrialRECRUITINGNA

NCT06603324

Analysis of Paediatric Treatments With multiFiltratePRO

This clinical study evaluates the performance of the MultifiltratePro in pediatric mode for Continuous Venovenous Hemodiafiltration (CVVHD) in children. Its primary aim is to assess the efficacy of the MultifiltratePro in paediatric mode, specifically in achieving at least 80% of the prescribed effluent dose within 72 hours. Additionally, the study focuses on the safety of this mode in a paediatric setting, closely monitoring for clinical adverse events, hemodynamic instability, and electrolyte imbalances. Paediatric patients with body weights between 8kg and 40kg will be treated with the MultifiltratePro for a period of up to 10 days, with the treatment duration and approach being tailored to the severity of each patient's condition.

Renal Failure · CVVHD

TrialRECRUITINGNA

NCT06774820

Biceps Lasso Loop and Self- Locking Tenodesis Alongside Repair of Rotator Cuff Tears: Randomised Controlled Trial Study Protocol (BLAST 1)

The aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double 360 lasso loop biceps tenodesis for the treatment of long chief of biceps or superior labrum anterior-posterior (SLAP) tendon pathology during shoulder arthroscopy in patients undergoing arthroscopic rotator cuff repair. Currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. Numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. At Clinique Générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. There are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis. Given its potential advantages, self-locking biceps tenodesis could emerge as the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as Popeye deformity. The information provided by this study could potentially guide future clinical practice, helping surgeons to choose the most appropriate treatment for their patients suffering from long biceps tendon pathology.

Rotator Cuff Injury

TrialRECRUITING

NCT06368648

CoMind Early Feasibility Study

The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain. Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices. Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.

Intracranial Pressure · Intracranial Pressure Changes · Traumatic Brain Injury · Intracerebral Hemorrhage

TrialRECRUITINGNA

NCT07324421

Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT

The primary goal of neurocritical care is to prevent secondary brain injury, which worsens neurological outcomes. Because clinical monitoring is often insufficient due to the patient's condition and medical treatments, multimodal monitoring using biophysical, electrophysiological, and imaging data is essential. In patients with subarachnoid hemorrhage (SAH), the most frequent and severe complication is delayed cerebral ischemia, often linked to arterial vasospasm and potentially leading to infarction. Early diagnosis combines transcranial Doppler (TCD), sensitive to vasospasm, with perfusion CT (CTP), which measures cerebral perfusion; this approach guides therapy and improves prognosis. Ultrasound, especially when enhanced with contrast agents (CEUS), allows non-invasive, bedside, repeated visualization of cerebral blood flow and perfusion-even through the skull. Agents like SonoVue® help quantify perfusion using time-intensity curves. The study aims to assess whether cerebral perfusion measurements from the SYLVER device are equivalent to those from CTP in ICU or CCU patients.

Neuro ICU · Sub Arachnoid Hemorrhage · Neurological Complication · Cerebral Ischemia

TrialRECRUITINGPHASE3

NCT07482787

Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa

The upcoming trial is for EB patients is a topically applied whole-body treatment of patients with either Simplex, RDEB or Junctional (nH) ages 1 month to 12 years old at study entry. There are only 4 site visits by patients with minimal assessments over a 2-month period, and patients completing this study will have the ability to continue receiving SD-101-6.0 at home in an open-label extension study. The drug product and placebo require no special preparation or storage conditions (room temperature).

Epidermolysis Bullosa (EB)

TrialRECRUITING

NCT06912477

Endothelial Dysfunction for Prognosis In Patients With preeClampSia

Preeclampsia is a pregnancy-specific hypertensive disorder and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial and microcirculatory dysfunction mediate systemic preeclampsia-related organ dysfunctions. Changes in endothelial and vascular function in preeclampsia have been demonstrated through reduced flow-mediated vasodilation as a result of reduced availability of nitric oxide, which potentially persists up to several years postpartum. Hyperspectral imaging is a new innovative technology that allows to assess the peripheral microcirculation and perfusion non-invasively and contactless, but has never been evaluated in the context of preeclampsia before. This EPICS project (Endothelial dysfunction for Prognosis In patients with preeClampSia) is a prospective observational study and aims to investigate hyperspectral imaging as a new potential diagnostic and prognostic marker in preeclampsia.

Preeclampsia (PE) · Hypertensive Disorder of Pregnancy

TrialRECRUITINGNA

NCT07722130

Epidural Spinal Cord Stimulation for Respiratory Recovery in Cervical SCI

This multicenter, single-arm exploratory IIT evaluates epidural spinal cord electrical stimulation (ESCES) in 20 adults with C1-C5 SCI and respiratory failure. Participants receive ESCES plus standard care; electrodes are implanted at C3-C5 with daily individualized stimulation. Primary outcomes: Edi peak, change of Edi peak and frequency. Secondary: tidal volume, maximal inspiratory pressure, NVE, NME, diaphragm ultrasound, cough strength, 90-day ventilator-free days, ICU stay, and survival. This is the first systematic ESCES study for SCI-related respiratory failure, aiming to provide preliminary safety/efficacy data for future RCTs.

Spinal Cord Injury Cervical · Respiratory Failure

TrialRECRUITING

NCT07805564

Evaluation of the Association Between the VEXUS Score and Hemodynamic Status and the Occurrence of Acute Kidney Injury After Open-Heart Surgery

Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass and is associated with prolonged intensive care unit stay, increased morbidity, and mortality. Fluid overload and venous congestion are increasingly recognized as important contributors to postoperative organ dysfunction. The VExUS score is a bedside ultrasound tool that assesses systemic venous congestion through evaluation of the inferior vena cava and Doppler flow patterns in the hepatic, portal, and intrarenal veins. Although previous studies have suggested an association between VExUS-assessed venous congestion, AKI, and adverse outcomes, evidence regarding its relationship with advanced hemodynamic parameters remains limited. This prospective observational study will enroll adult patients undergoing cardiac surgery with cardiopulmonary bypass. All patients will undergo postoperative VExUS assessment and will be followed for the development of AKI and other postoperative complications. A predefined subgroup of patients undergoing clinically indicated PiCCO monitoring will additionally be evaluated to determine the association between VExUS score and PiCCO-derived hemodynamic parameters. The findings may support the use of VExUS as a noninvasive bedside tool for assessing venous congestion and identifying patients at increased risk of postoperative organ dysfunction after cardiac surgery.

Acute Kidney Injury After Open Heart Surgery · Venous Congestion After Open Heart Surgery

TrialRECRUITINGPHASE3

NCT07613099

Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging

Background: Injury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help. Objective: To test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease. Eligibility: People aged 18 years and older with lung or heart disease that may cause scarring in those organs. Design: Participants will have 6 clinic visits over 2 years. Participants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart. The study tracer will be used with positron emission tomography (PET)/computed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine. Participants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits. Participants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....

Allogeneic Stem Cell Transplantation · Lung Allograft Transplantation · Interstitial Lung Disease · Acute Lung Injury

TrialRECRUITING

NCT07324694

Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery

Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. This prospective cohort study aims to evaluate the association between intraoperative hemodynamic instability (defined as MAP \< 65 mmHg or vasopressor requirement) and major postoperative complications (Delirium, Acute Kidney Injury, Stroke, or Mortality) in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.

Cardiac Surgery · Intraoperative Hemodynamic Instability · Postoperative Complication · Acute Kidney Injury

Clinical Evidence