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Cardiogenic shock (CS) is critical end-organ hypoperfusion attributable to reduced cardiac output. Acute ST-segment-elevation myocardial infarction with CS (AMI-CS) has high mortality. Clinical research is challenging in such patients as they often cannot provide consent, lack available legal representatives, and require initiation of therapy. Multiple trials have enrolled patients with AMI-CS outside the United States under deferred consent. Trials in the United States have enrolled patients with out-of-hospital cardiac arrest under exception from informed consent (EFIC). However, AMI-CS has a longer therapeutic window to initiate treatment than out-of-hospital cardiac arrest, and more patients or their representatives can engage in treatment decisions. We provide a rationale for how a trial enrolling patients with AMI-CS could qualify for conduct using EFIC by meeting each criterion specified in US human subject regulations. AMI-CS is a life-threatening situation, available treatments are unsatisfactory, and collection of valid evidence is necessary. Obtaining informed consent is often not feasible, and trial participation could benefit subjects. Only enrolling consented patients is impracticable and could reduce the study's generalizability. We propose a therapeutic window of 30 minutes within the study intervention must be initiated, with consent sought within 15 minutes, respecting any refusal or objection to enrollment, and otherwise enrollment under EFIC. A trial could enroll patients with AMI-CS under EFIC and can involve both patients and their representatives. Successful use of EFIC in trials of other interventions in patients with CS or enrolling patients with other acute cardiovascular conditions could increase the available evidence base to improve care.

Background: Social determinants of health such as residential segregation have been identified as drivers of disparities in health outcomes; however, this has been understudied for out-of-hospital cardiac arrest (OHCA). We sought to examine whether there were differences in survival to discharge and survival with good neurological outcome, as well as likelihood of bystander cardiopulmonary resuscitation, using validated measures of racial, ethnic, and economic segregation., Methods: We conducted a retrospective observational study using data from the Cardiac Arrest Registry to Enhance Survival data set. The primary predictor for this study was the Index of Concentration at the Extremes. The primary outcomes were survival to discharge and survival with good neurological status., Results: During the study period, 626 264 had an out-of-hospital cardiac arrest, and patients had a mean age of 62 years (SD 17.2 years). In multivariable models, we observed an increased likelihood of survival to discharge and survival with good neurological outcome for those patients residing in more highly segregated predominately White population and higher-income census tracts as compared with more highly segregated and lower-income Black and Hispanic/Latinx population census tracts. We found that the magnitude of this disparity was 24% for the outcome of survival to discharge as compared with reference (relative risk,1.24 [95% CI, 1.20-1.28])., Conclusions: This research suggests that areas impacted by residential and economic segregation are important targets for both public policy interventions as well as addressing disparities in care across the chain of survival for out-of-hospital cardiac arrest.

Background: An early rhythm control strategy is the preferred management for patients newly diagnosed with atrial fibrillation (AF). A rhythm control strategy, however, has been historically underused for patients from underrepresented racial and ethnic groups (UREGs)., Objective: We aimed to determine whether disparities in rhythm control are present at the initial diagnosis with AF., Methods: We used the Get With the Guidelines (GWTG)-Atrial Fibrillation registry to compare the use of a rhythm control strategy among patients with different racial and ethnic backgrounds hospitalized with a new diagnosis of AF from January 2013 through December 2023., Results: Among 21,567 patients hospitalized for newly detected AF across 249 hospitals, 17,659 patients (81.9%) identified as non-Hispanic White (NHW), 1,860 patients (8.6%) identified as Black, 1,232 patients (5.7%) identified as Hispanic, and 255 patients (1.2%) identified as Asian. After adjusting for age, sex, and year of presentation, NHW patients were more likely to receive rhythm control (odds ratio [OR], 1.19 [1.07, 1.33], P = .0013) compared with non-White patients at the time of initial diagnosis with AF. Black patients were less likely to receive rhythm control compared with all other racial and ethnic groups (OR, 0.80 [0.71, 0.91], P = .0005). These differences persisted after fully adjusting for demographic characteristics, clinical variables, hospital characteristics, and socioeconomic factors., Conclusions: Differences in rhythm management exist amongst patients from different racial and ethnic groups. Efforts to mitigate disparities in AF management should include an emphasis on rhythm control at the time of initial diagnosis., Competing Interests: Disclosure Dr Jackson serves as a consultant to Biosense Webster, Johnson and Johnson, Sanofi, Bristol Myers Squibb, and Pfizer and receives honoraria from PRIME Education. Dr Piccini is supported by R01AG074185 from the National Institutes of Aging. He also receives grants for clinical research from Abbott, the American Heart Association, Bayer, Boston Scientific, iRhythm, and Philips and serves as a consultant to Abbott, Abbvie, Bayer, Boston Scientific, Element Science, Milestone, ElectroPhysiology Frontiers, Medtronic, Sanofi, Pacira, Philips, and Up-to-Date. Dr Reddy reports the following disclosures with medical companies not related to this manuscript: Abbott (Consultant), Ablacon (Consultant, Equity), Acutus Medical (Consultant, Equity), Affera (Consultant, Equity), Apama Medical (Consultant, Equity), Aquaheart (Consultant, Equity), Autonomix (Consultant, Equity), Axon (Consultant), Backbeat (Consultant, Equity), BioSig (Consultant, Equity), Biosense-Webster (Consultant), Biotronik (Consultant), Boston Scientific (Consultant), Cardiofocus (Consultant), Cardionomic (Consultant), CardioNXT / AFTx (Consultant), Circa Scientific (Consultant, Equity), Corvia Medical (Consultant, Equity), East End Medical (Consultant, Equity), EBR (Consultant), EPD (Consultant, Equity), Epix Therapeutics (Consultant, Equity), EpiEP (Consultant, Equity), Eximo (Consultant, Equity), Farapulse (Consultant, Equity), Fire1 (Consultant, Equity), Impulse Dynamics (Consultant), Javelin (Consultant, Equity), Keystone Heart (Consultant, Equity), LuxCath (Consultant, Equity), Manual Surgical Sciences (Equity), Medlumics (Consultant, Equity), Medtronic (Consultant), Middlepeak (Consultant, Equity), Newpace (Equity), Nuvera (Consultant, Equity), Philips (Consultant), Stimda (Consultant), Surecor (Equity), Thermedical (Consultant), Valcare (Consultant, Equity), Vizara (Equity), and VytronUS (Consultant, Equity). Dr Curtis has the following disclosures: Medtronic: advisory board, honoraria for speaking; Abbott: advisory board, honoraria for speaking; Janssen Pharmaceuticals: advisory board; Milestone Pharmaceuticals: advisory board. The Get With The Guidelines–AFib (GWTG-AF) program is provided by the American Heart Association. GWTG-AF is sponsored, in part, by BMS Pfizer, Tylenol, and Philips Image Guided Therapy. None of the coauthors received funding for this project. The funders of this project had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The authors have stated their conflicts of interest, none of which were related to this project. No company or agency had any role in this manuscript., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives. To determine the association between parental characteristics and MMR (measles-mumps- rubella) vaccination status of children in the United States. Methods. We conducted a cross-sectional study from July 2023 to April 2024 using a digital health survey via OutbreaksNearMe, weighted to target national population characteristics. We analyzed the responses of 19 892 parents of children younger than 5 years to examine the association between self-reported parental characteristics (i.e., sociodemographics, politics, COVID-19 vaccination status) and children's MMR vaccination rates using logistic regression. Results. Children of parents who received at least 1 dose of the COVID-19 vaccine had higher MMR vaccination rates (80.8%) than did children of unvaccinated parents (60.9%; odds ratio [OR] = 1.84; 95% confidence interval [CI] = 1.68, 2.00). We observed lower MMR vaccination rates among children of parents who identified as Republican versus Democratic (OR = 0.73; 95% CI = 0.64, 0.82), parents on Medicaid or Medicare versus private insurance (OR = 0.85; 95% CI = 0.76, 0.95), and minority (OR = 0.44) versus White (OR = 0.71) parents. We found higher MMR vaccination rates in the Northeast and Midwest United States. Conclusions. Early data indicate that parental sociodemographic characteristics and COVID-19 vaccine status are associated with children's MMR vaccine uptake, emphasizing the need for further investigations into multipronged public health interventions. ( Am J Public Health . 2025;115(3):369-373. https://doi.org/10.2105/AJPH.2024.307912).

Background: Investigations into long-term fine particulate matter (PM 2.5 ) exposure's impact on nonaccidental and cardiovascular (CVD) deaths primarily involve nonrepresentative adult populations at concentrations above the new Environmental Protection Agency annual PM 2.5 standard., Methods: Using generalized linear models, we studied PM 2.5 exposure on rates of five mortality outcomes (all nonaccidental, CVD, myocardial infarction, stroke, and congestive heart failure) in 12 US states from 2000 to 2016. We aggregated predicted annual PM 2.5 exposures from a validated ensemble exposure model, ambient temperature from Daymet predictions, and mortality rates to all census tract-years within the states. We obtained covariates from the decennial Census and the American Community Surveys and assessed effect measure modification by race and education with stratification., Results: For each 1-µg/m 3 increase in annual PM 2.5 , we found positive associations with all five mortality outcomes: all nonaccidental (1.08%; 95% confidence interval [CI]: 0.96%, 1.20%), all CVD (1.27%; 95% CI: 1.14%, 1.41%), myocardial infarction (1.89%; 95% CI: 1.67%, 2.11%), stroke (1.08%; 95% CI: 0.87%, 1.30%), and congestive heart failure (2.20%; 95% CI: 1.97%, 2.44%). Positive associations persisted at <8 µg/m 3 PM 2.5 levels and among populations with only under 65. In our study, race, but not education, modifies associations. High-educated Black had a 2.90% larger increased risk of CVD mortality (95% CI: 2.42%, 3.39%) compared with low-educated non-Black., Conclusion: Long-term PM 2.5 exposure is associated with nonaccidental and CVD mortality in 12 states, below the new Environmental Protection Agency standard, for both low PM 2.5 regions and the general population. Vulnerability to CVD mortality persists among Black individuals regardless of education level., Competing Interests: Disclosure: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Public deliberation is an approach used to engage persons with diverse perspectives in discussions and decision-making about issues affecting the public that are controversial or value laden. Because experts have identified the need to evaluate facilitator performance, our research team developed a framework to assess the fidelity of facilitator remarks to key principles of public deliberation., Objective: This report describes how the framework was used to assess facilitator fidelity in a 4-site public deliberation project on the acceptability of minor self-consent in biomedical HIV prevention research., Methods: A total of 88 individuals participated in 4 deliberation sessions held in 4 cities throughout the United States. The sessions, facilitated by 18 team members, were recorded and transcribed verbatim. Facilitator remarks were highlighted, and predetermined coding rules were used to code the remarks to 1 of 6 principles of quality deliberations. A variety of display tables were used to organize the codes and calculate the number of facilitator remarks that were consistent or inconsistent with each principle during each session across all sites. A content analysis was conducted on the remarks to describe how facilitator remarks aligned or failed to align with each principle., Results: In total, 735 remarks were coded to one of the principles; 516 (70.2%) were coded as consistent with a principle, and 219 (29.8%) were coded as inconsistent. A total of 185 remarks were coded to the principle of equal participation (n=138, 74.6% as consistent; n=185, 25.4% as inconsistent), 158 were coded to expression of diverse opinions (n=110, 69.6% as consistent; n=48, 30.4% as inconsistent), 27 were coded to respect for others (n=27, 100% as consistent), 24 were coded to adoption of a societal perspective (n=11, 46% as consistent; n=13, 54% as inconsistent), 99 were coded to reasoned justification of ideas (n=81, 82% as consistent; n=18, 18% as inconsistent), and 242 were coded to compromise or movement toward consensus (n=149, 61.6% as consistent; n=93, 38.4% as inconsistent). Therefore, the counts provided affirmation that most of the facilitator remarks were aligned with the principles of deliberation, suggesting good facilitator fidelity. By considering how the remarks aligned or failed to align with the principles, areas where facilitator fidelity can be strengthened were identified. The results indicated that facilitators should focus more on encouraging quieter members to participate, refraining from expressing personal opinions, promoting the adoption of a societal perspective and reasoned justification of opinions, and inviting deliberants to articulate their areas of common ground., Conclusions: The results provide an example of how a framework for assessing facilitator fidelity was used in a 4-site deliberation project. The framework will be refined to better address issues related to balancing personal and public perspectives, managing plurality, and mitigating social inequalities., (©Claire Burke Draucker, Andrés Carrión, Mary A Ott, Ariel I Hicks, Amelia Knopf. Originally published in JMIR Formative Research (https://formative.jmir.org), 13.02.2025.)

Introduction: American Indian and Alaska Native (AI/AN) communities in the United States (U.S.) face greater oral healthcare inequities than other groups in the country. A solution to improving oral healthcare access for American Indian and Alaska Native communities in the United States is the integration of dental therapists (DT). However, it has been met with opposition. The goal of this study was to explore oral health provider engagement and perspectives of DT implementation in local communities., Methods: Engagement related to DT from the dental provider perspective from the ADTA conference's attendees were analyzed via optional, electronic post-conference surveys. Descriptive statistics were utilized to report the position type of attendees, years of experience in the role, incorporation of clinical courses for DT scope of practice, and clinic management and administration for their patients. Surveys included two open-ended questions inquiring about personal objectives and comments and suggestions regarding the conference overall. From attendee's open-ended statements on objectives for attending this conference, key patterns were described., Results: One hundred people nationwide attended the conference. Of these attendees, 56% completed the post-conference survey evaluation. Among the respondents, 25% identified as dentists, 23% identified as dental hygienists, 46% identified as dental therapists, 6% identified as other oral health workforce members (i.e., dental assistant and/or Tribal oral health coordinator). The majority felt the strategies covered related to DT could be incorporated regardless of the type of workforce position. Fifty-seven percent of dentists felt it would be easy or very easy to implement strategies from the conference, and 75% of dental hygienists and other oral health workforce members felt it was easy or very easy to implement strategies from the conference. Education, advocacy, and networking were identified as the main objectives for attending the conference., Discussion: The conference platform encouraged dissenting viewpoints to contribute to academic and policy debates to ultimately provide broader access to oral healthcare through a comprehensive team approach. There was strong support across positions to advocate for and expand DT to the lower 48 states of the U.S., particularly in areas with underserved communities. Additionally, most providers felt this could be done with ease and no providers indicated opposition in open-ended remarks. Collaborative efforts among policymakers, dental associations, educational institutions, and community advocates can create a pathway for the successful integration of dental therapists into the healthcare system., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2025 Llaneza, Stone and Seward.)

Food protein-induced enterocolitis syndrome (FPIES) is a non-IgE-mediated gastrointestinal food allergy characterized by delayed, protracted vomiting and accompanied by lethargy and pallor, usually 1 to 4 hours after ingesting the food allergen. The pathophysiology of FPIES remains unknown, and currently there are no diagnostic biomarkers available to assess disease activity or its resolution. Over the last 2 decades, FPIES has become increasingly recognized in both pediatric and adult patients. Forty years after the initial FPIES description, the first FPIES code appeared in the International Classification of Diseases, Tenth Revision (ICD-10), and the first international consensus guidelines for the diagnosis and management of FPIES were published. On June 22, 2022, the National Institute of Allergy and Infectious Diseases (NIAID) held its first virtual multidisciplinary workshop on FPIES. Various clinical and translational aspects of FPIES as well as important areas of unmet needs were discussed as priorities for future research during this 2-day virtual workshop. Our report provides a summary of content of the workshop, including updated literature on the topic areas, and also provides critical commentary on the state of FPIES., Competing Interests: Disclosure statement The workshop was supported by funds from the Division of Allergy, Immunology, and Transplantation, National Institute of Allergy and Infectious Diseases (NIAID). The authors of this report are responsible for its content. Statements in the report do not necessarily represent the official views of or imply endorsement by the National Institutes of Health, NIAID, the Department of Health and Human Services, or any other agency of the United States government. Disclosure of potential conflict of interest: A. Nowak-Wegrzyn reports research support from Alladapt Immunotherapeutics, DBV Technologes, Siolta Therapeutics, and Regeneron; speaking fees from Nestlé, Danone, and Thermo Fisher; consulting fees from Aquestive; royalties from UpToDate; and service as associate editor for Annals of Allergy, Asthma & Immunology, chair of the ABAI board of directors, director of the AAAAI board, and chair of the medical advisory board of the International FPIES Association. S. H. Sicherer reports royalty payments from UpToDate and from Johns Hopkins University Press; grants to his institution from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID), Food Allergy Research and Education (FARE), and Pfizer; and personal fees from the American Academy of Allergy, Asthma & Immunology as deputy editor of the Journal of Allergy and Clinical Immunology: In Practice outside the submitted work. C. Akin reports consultancy and research support from Blueprint Medicine and Cogent for tyrosine kinase inhibitor therapies in mastocytosis outside the submitted work. S. Anvari receives funding from NIH NIAID and DBV Technologies for contracted work outside of the submitted work; and reports consultancy with DBV Technologies. L. M. Bartnikas receives research support from NIH NIAID, the International FPIES Association (IFPIES), and the Myles & Gertrude Hanson Foundation. M. C. Berin reports compensation for service on the scientific advisory board for Enterome. T. A. Bingemann reports service on the board of directors of the American Board of Allergy and Immunology and the board of regents for the American College of Allergy, Asthma and Immunology; is a member of the executive committee for AAP’s Section of Allergy and Immunology; has been a speaker for Sanofi; has been a consultant for ALK, Bryn, and Aimmune; and has served as principal investigator on a Novartis trial. G. du Toit reports grants from NIH NIAID, FARE, MRC & Asthma UK Centre, Action Medical Research, and the National Peanut Board; is scientific advisory board member for Aimmune; is investigator on pharma-sponsored peanut allergy immunotherapy studies (Aimmune, DBV Technologies, and Novartis); and is joint director of The Food Allergy Immunotherapy Centre. M. Groetch reports royalties from UpToDate, FARE, and the Academy of Nutrition and Dietetics; and serves on the medical advisory board of IFPIES, as a senior advisor to FARE, as a health sciences advisor for the American Partnership for Eosinophilic Disorders, and on the editorial board of Journal of Food Allergy. F. Schultz is employed by IFPIES; and is a consultant for Aijinomoto Cambrooke. C. Venter reports grants from Reckitt Benckiser; and personal fees from Reckitt Benckiser, Nestlé Nutrition Institute, Danone, Abbott Nutrition Else Nutrition, Sifter, Owyn, and Before Brands outside the submitted work. A. Westcott-Chavez is employed by IFPIES. R. A. Wood reports research support from Takeda Pharmaceuticals outside the submitted work. The rest of the authors declare that they have no relevant conflicts of interest., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. All rights reserved.)

Background: Some patients undergo thyroidectomy while hospitalized for a related or independent indication. Outcomes have not been described in this group., Methods: The 2016-2018 thyroidectomy-targeted NSQIP datasets were queried for patients admitted for ≥1 day preoperatively. 1:1 propensity score matching was employed to compare the outcomes of admitted patients to outpatients, including surgical and thyroidectomy-specific outcomes. Multivariable logistic regression determined factors associated with poor outcomes., Results: Of 18,078 patients, 312 were admitted at least 1 day prior to surgery. Inpatients had higher ASA classifications and rates of several comorbidities compared to the general population. After propensity score matching, inpatients had higher rates of overall complications, unplanned reoperation, and bleeding. They also experienced higher rates of thyroidectomy-specific complications such as hypocalcemia and neck hematoma. By multivariable regression, admission prior to surgery was associated with development of any complications., Conclusion: Thyroidectomy in hospitalized patients carries an increased risk of complications. Patients requiring thyroidectomy while already hospitalized should be counseled accordingly., Competing Interests: Declaration of competing interest The authors have no financial, personal, or professional conflicts of interest to disclose which may have biased this work. No portions of this manuscript were generated using any form of artificial intelligence technology., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: Women with germline BRCA1/2 pathogenic variants (gBRCA1/2) are recommended to undergo annual breast MRI and mammography. Our objective was to describe the frequency of insurance denials for annual breast MRIs in women with gBRCA1/2 and determine denial trends., Methods: Women with gBRCA1/2 following in a high-risk breast cancer clinic with breast MRIs ordered from 2020 to 2021 were identified and cross-referenced with a database of insurance denials. Radiology records were queried to determine if screening breast MRIs were performed in 2020 and 2021. Rates of MRI denials and outcomes after appeal were determined., Results: There were 682 women with gBRCA1/2 who had screening breast MRIs ordered from 2020 to 2021, including 318 (47 %) BRCA1, 356 (52 %) BRCA2, and 8 (1 %) with both. 73 women (11 %) had an MRI denied. Women insured through Medicaid had the highest rates of denials (2020: 7 %, 2021: 18 %), followed by commercial insurance (2020: 6 %, 2021: 9 %). There were significantly more denials in 2021 compared to 2020 (p = 0.044), and 2021 denials were more likely to be denied on appeal. Of women with denials, 4 (14 %) in 2020 and 5 (11 %) in 2021 did not have a screening MRI performed. One patient with DCIS had an MRI denial prior to diagnosis., Conclusion: Breast MRI insurance denials were present in 11 % of this high-risk cohort, and 14 % of women with denials did not undergo annual screening. There were significantly more denials in 2021, suggesting worsening barriers for these patients and added burden on providers to appeal for appropriate screening tests., Competing Interests: Declaration of competing interest Dr. Abu-Rustum reports research funding paid to the institution from GRAIL., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Question: The opioid epidemic causes massive morbidity, and males have substantially greater overdose mortality rates than females. It is unclear whether there are sex-related disparities at different stages in the trajectory of opioid use disorders (OUD), from large samples in the community., Goal: To determine sex disparities in non-medical opioid use (NMOU) at the end of treatment with medications for opioid use disorder (MOUD), using national data., Design: Observational study of outpatient MOUD programs in the "Treatment episode data set-discharges" (TEDS-D) for 2019., Participants: Persons aged ≥ 18 in their first treatment episode, in outpatient MOUD-based therapy for heroin or other opioids (N = 10,065). The binary outcome was presence/absence of NMOU in the month prior to discharge., Results: In univariate analyses, males had higher odds of NMOU compared to females (odds ratio=1.22; p = 6.84 ×10 -5 after Bonferroni correction). A multivariable logistic regression detected a relatively small male>female odds ratio of 1.14 (p = 0.0039), surviving adjustment for demographic variables and social determinants of health. Several specific conditions were revealed in which males had greater odds of NMOU compared to females (e.g., if they were in the white racial category, and were not of hispanic ethnicity). Also, using by smoking, inhalation or injection routes (versus oral) was associated with greater odds of NMOU, irrespective of sex., Conclusions: This national community sample shows that males overall have greater odds of NMOU in their first treatment episode with MOUD, a potential indicator of more unfavorable outcomes. Further analyses should examine the underpinnings of this disparity, including clinical severity features., Competing Interests: Declaration of Competing Interest No conflict of interest declared., (Copyright © 2025 Elsevier B.V. All rights reserved.)

Background: PAH exposure is associated with adverse health outcomes, but exposure sources in pregnancy are not well-understood., Objectives: We examined associations between urinary OH-PAHs during pregnancy and environmental tobacco smoke (ETS) and short-term ambient air pollution exposure. Participants included 1603 pregnant non-smokers in three cohorts from 7 sites across the USA. We also examined associations with intake of foods typically high in PAHs in one cohort with dietary assessment data (n = 801)., Methods: Urinary OH-PAHs were measured using LC-MS/MS; urinary cotinine was measured using SPE/UPLC-MS/MS. To accommodate different detection limits by cohort, ETS exposure was represented by modified cotinine quartiles; these combined concentrations below the highest detection limit in the first category (0-0.017 ng/mL), with the rest divided evenly into three categories (0.0171-0.2 ng/mL, 0.21-1.191 ng/mL, 1.192-1465 ng/mL). Air pollution exposure was represented by quartiles of same-day ambient PM 2.5 in residential census tracts estimated from EPA's Downscaler Model. We fitted separate Tobit regression models for log-OH-PAH concentrations in association with cotinine or ambient PM 2.5 quartile adjusted for specific gravity, site, batch, household income, education, employment status, neighborhood deprivation index, season, and year. For the food model, PAH dietary intakes were estimated using food frequency questionnaire data and standard portion weights from a national database., Results: In adjusted models, the highest modified cotinine quartile vs. the lowest was associated with 48% (95% CI: 13%, 94%) higher urinary 1-hydroxynaphthalene, 36% (15%, 61%) higher 2-hydroxynaphthalene, 41% (23%, 63%) higher 3-hydroxyphenanthrene, and 70% (28%, 127%) higher 1-hydroxypyrene. Second and third quartile cotinine concentrations were associated with higher OH-PAHs, although not consistently. Same-day ambient PM 2.5 was not associated with any OH-PAH, nor was self-reported dietary intake., Conclusions: ETS is a major source of PAH exposure for pregnant people in the USA while ambient PM 2.5 and diet measured via usual intakes appear less influential. Our findings underscore the importance of policies/actions to reduce environmental tobacco smoke exposure among pregnant people., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: To provide a narrative overview of trends and disparities in the cardiometabolic profiles of U.S. adults by synthesizing findings from nationally representative studies conducted between 1999 and 2020., Recent Findings: During the study period, the cardiometabolic profiles of U.S. adults displayed a complex mix of trends. While there were notable improvements in specific risk factors, such as reductions in total cholesterol, triglycerides, and low-density lipoprotein cholesterol levels, other aspects of cardiometabolic health worsened. The mean body mass index and hemoglobin A1c levels increased, accompanied by significant rises in the prevalence of obesity, type 2 diabetes, and metabolic syndrome. Despite some progress in blood pressure and lipid profiles, the overall cardiometabolic health of the population declined, with only a small percentage of adults maintaining optimal health by 2018. Furthermore, significant disparities persisted across racial and socioeconomic groups, with non-Hispanic Black participants and those with lower education and income facing higher cardiometabolic risks compared to their counterparts. Despite improvements in certain aspects of cardiometabolic profiles among U.S. adults, significant challenges remain, particularly with the rising rates of obesity, type 2 diabetes, and metabolic syndrome. Persistent disparities in cardiometabolic health across sociodemographic groups emphasize the need for comprehensive public health strategies that address medical care, lifestyle factors, and social determinants of health. Future efforts should prioritize reducing these disparities and enhancing health equity to mitigate the overall burden of cardiometabolic disease., Competing Interests: Declarations. Human and Animal Rights and Informed Consent: This review article does not contain any studies with human or animal subjects performed by any of the authors. Competing Interests: The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The suicide rate for United States military veterans is 1.5× higher than that of non-veterans. To meaningfully advance suicide prevention efforts, research is needed to delineate factors that differentiate veterans with suicide attempt/s, particularly in high-risk groups, e.g., major depressive disorder (MDD), from those with suicidal ideation (no history of attempt/s). The current study aimed to identify clinical, neurocognitive, and neuroimaging variables that differentiate suicide-severity groups in veterans with MDD., Methods: Sixty-eight veterans with a DSM-5 diagnosis of MDD, including those with no ideation or suicide attempt (N = 21; MDD-SI/SA), ideation-only (N = 17; MDD + SI), and one-or-more suicide attempts (N = 30; MDD + SA; aborted, interrupted, actual attempts), participated in this study. Participants underwent a structured diagnostic interview, neurocognitive assessment, and 3 T-structural/diffusion tensor magnetic-resonance-imaging (MRI). Multinomial logistic regression models were conducted to identify variables that differentiated groups with respect to the severity of suicidal behavior., Results: Relative to veterans with MDD-SI/SA, those with MDD + SA had significantly higher left cingulum fractional anisotropy, decreased attentional control on emotional-Stroop, and faster response time with intact accuracy on Go/No-Go. Relative to MDD + SI, MDD + SA had higher left cingulum fractional anisotropy and faster response time with intact accuracy on Go/No-Go., Limitations: Findings are based on retrospective, cross-sectional data and cannot identify causal relationships. Also, a healthy control group was not included given the study's focus on differentiating suicide profiles in MDD., Conclusions: This study suggests that MRI and neurocognition differentiate veterans with MDD along the suicide-risk spectrum and could inform suicide-risk stratification and prevention efforts in veterans and other vulnerable populations., Competing Interests: Declaration of competing interest None., (Copyright © 2024. Published by Elsevier B.V.)

Elevated cancer incidence has been reported among World Trade Center (WTC)-exposed responders, with some incidence rate ratios (IRRs) varying over time. This study describes the influence that different reference populations have on relative cancer incidence and temporal trends. Participants from the WTC Combined Rescue/Recovery Cohort (n = 65,691) were observed between 1/1/2002 and 12/31/2015 using data obtained from 13 state cancer registries. Poisson regression was used to estimate IRRs controlling for age, race/ethnicity, and calendar year. IRRs and change-points were estimated using three reference populations (New York City (NYC), New York State (NYS), and a US population). IRRs for each cancer site varied in magnitude. Prostate and thyroid cancer IRRs were significantly greater in WTC-exposed responders, while colon and lung cancer IRRs were significantly lower compared with NYC, NYS, and US population reference groups. The range of IRRs varied by reference population. Mixed findings were observed for other cancers, as results were dependent on the reference group used. A significant change-point was found only for prostate cancer, and only when compared to a US population. Our findings suggest that reference population selection will influence the IRR, timing, and statistical significance of change-point estimation, varying with follow-up length., Competing Interests: Declarations. Competing interests: The authors declare no competing interests. Ethics approval: All responders who were members of any of the three cohorts and either provided informed consent for research or were covered under a research ethics board, or Institutional Review Board (IRB)-approved waiver of consent were eligible for inclusion in analyses. These include: the Albert Einstein College of Medicine/Montefiore Medical Center: IRB#2016–6692; the NYC Department of Health and Mental Hygiene: IRB #16–130; the NYS Department of Health: IRB #16–052; and the Icahn School of Medicine at Mt. Sinai: IRB#: 16–00814. This work was performed in accordance with the Declaration of Helsinki and all relevant guidelines and regulations. Consent to participate: All responders who were members of any of the three cohorts and either provided informed consent for research or were covered under a research ethics board, or Institutional Review Board (IRB)-approved waiver of consent were eligible for inclusion in analyses. Consent to publish: Not required., (© 2024. The Author(s).)

Objective: To compare the guidelines offered by the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) on adult sinusitis to chatbots., Methods: ChatGPT-3.5, ChatGPT-4.0, Bard, and Llama 2 represent openly accessible large language model-based chatbots. Accuracy, over-conclusiveness, supplemental, and incompleteness of chatbot responses were compared to the AAO-HNS Adult sinusitis clinical guidelines., Results: 12 guidelines consisting of 30 questions from the AAO-HNS were compared to 4 different chatbots. Adherence to AAO-HNS guidelines varied, with Llama 2 providing 80 % accurate responses, BARD 83.3 %, ChatGPT-4.0 80 %, and ChatGPT-3.5 73.3 %. Over-conclusive responses were minimal, with only one instance each from Llama 2 and ChatGPT-4.0. However, rates of incomplete responses varied, with Llama 2 exhibiting the highest at 40 %, followed by ChatGPT-4.0 at 33.3 %, BARD at 23.3 %, and ChatGPT-3.5 at 36.7 %. Fisher's Exact Test analysis revealed significant deviations from the guideline standard, with less accuracy (p = 0.012 for Llama 2, p = 0.026 for BARD, p = 0.012 for ChatGPT-4.0, p = 0.002 for ChatGPT-3.5), inclusion of supplemental data (p < 0.001 for all), and less completeness (p < 0.01 for all) across all chatbots, indicating potential areas for enhancement in their performance., Conclusion: Although AI chatbots like Llama 2, Bard, and ChatGPT exhibit potential in sharing health-related information, their present performance in responding to clinical concerns concerning adult rhinosinusitis is not up to par with recognized clinical criteria. Future revisions should focus on addressing these shortcomings and placing an emphasis on accuracy, completeness, and conformity with evidence-based practices., Competing Interests: Declaration of competing interest I declare that there is no conflict of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Stroke triggers are factors that may precipitate a stroke within a given time interval and can predict the timing of a stroke. While hypoglycemia has been established as a risk factor for cardiovascular events such as acute ischemic stroke (AIS), there is limited research demonstrating hypoglycemic events as stroke triggers. We hypothesize an association between hypoglycemic events and the occurrence of stroke among patients with diabetes., Methods: We used Medicare inpatient, outpatient, emergency department, and subacute nursing facility data sets from January 1, 2016, to December 31, 2019, and validated using International Classification of Diseases , Tenth Revision , Clinical Modification codes to identify conditions. We used a case-crossover study design, testing whether exposure to a hypoglycemia encounter within progressively longer case periods (up to 30 days before index AIS) was associated with the subsequent occurrence of AIS, compared with control periods of equal length exactly 1 year before the case period. We used conditional logistical regression models to estimate odds ratios and 95% CIs., Results: There were 237 667 index admissions with AIS and diabetes during the study period. There were increased odds of AIS following an encounter with hypoglycemia. The risk was the highest immediately on the first day following the hypoglycemia encounter (odds ratio, 3.694 [95% CI, 2.694-5.065]; P <0.0001) and gradually became lower as the case-control period lengthened. At a 30-day case-control interval, the risk was lowest but still significant (odds ratio, 2.345 [95% CI, 2.179-2.523]; P <0.0001)., Conclusions: We found that hypoglycemic events in patients with diabetes are associated with a more than 3-fold greater risk of AIS in the first day but can trigger AIS in the 30 days following the event. More research is needed to assess the link between the severity of hypoglycemia and stroke occurrence, as well as the severity of the stroke. These results, if confirmed in other studies, emphasize the importance of avoiding hypoglycemic events in patients with diabetes., Competing Interests: None.

Background: Home-based primary care (HBPC) is an important care delivery model for high-need older adults. Currently, target patient populations vary across HBPC programs, hindering expansion and large-scale evaluation., Objectives: Develop and validate criteria that identify appropriate HBPC target populations., Research Design: A modified Delphi process was used to achieve expert consensus on criteria for identifying HBPC target populations. All criteria were defined and validated using linked data from Medicare claims and the National Health and Aging Trends Study (NHATS) (cohort n=21,727). Construct validation involved assessing demographics and health outcomes/expenditures for selected criteria., Subjects: Delphi panelists (n=29) represented diverse professional perspectives. Criteria were validated on community-dwelling Medicare beneficiaries (age ≥70) enrolled in NHATS., Measures: Criteria were selected via Delphi questionnaires. For construct validation, sociodemographic characteristics of Medicare beneficiaries were self-reported in NHATS, and annual health care expenditures and mortality were obtained via linked Medicare claims., Results: Panelists proposed an algorithm of criteria for HBPC target populations that included indicators for serious illness, functional impairment, and social isolation. The algorithm's Delphi-selected criteria applied to 16.8% of Medicare beneficiaries. These HBPC target populations had higher annual health care costs [Med (IQR): $10,851 (3316, 31,556) vs. $2830 (913, 9574)] and higher 12-month mortality [15% (95% CI: 14, 17) vs. 5% (95% CI: 4, 5)] compared with the total validation cohort., Conclusions: We developed and validated an algorithm to define target populations for HBPC, which suggests a need for increased HBPC availability. By enabling objective identification of unmet demands for HBPC access or resources, this algorithm can foster robust evaluation and equitable expansion of HBPC., Competing Interests: B.L. serves on clinical advisory boards for Patina Health, Medzed, and Pager. The remaining authors declare no conflict of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Purpose: Reimbursement strategies to regionalize care can be effective for improving patient outcomes but may adversely affect access to care. We sought to determine the effect on travel distance for surgical treatment of a 2009 New York State (NYS) policy restricting Medicaid reimbursement for breast cancer surgery at low-volume hospitals., Patients and Methods: From a linked data set merging the NYS tumor registry with hospital discharge data, we identified women younger than 65 years with stage I-III first breast tumors from pre- and post-policy periods. We classified patients by urbanicity of their residence into four geographic areas (New York City, other large urban core, suburban/large town, and small town/rural). A multivariable difference-in-difference-in-differences model was used to estimate the policy effect on the distance traveled by Medicaid and non-Medicaid insured patients before and after the policy, by area of residence., Results: Among the 46,029 study sample, 13.5% were covered by Medicaid. Regardless of insurance, women treated more recently traveled longer distances to their surgical facility than those in the prepolicy period. Regardless of time period, Medicaid beneficiaries drove fewer miles to treatment than women with other insurance. Although all women traveled greater distances postpolicy, the increase was not significantly different by insurance status (Medicaid or not), except for those living in suburban areas in which Medicaid patients traveled further postpolicy (+7.7 miles compared with +3.4 miles for non-Medicaid; P = .007)., Conclusion: After a policy regionalizing surgical care, only suburban Medicaid patients experienced a statistically significant (albeit small) increase in travel distance compared with non-Medicaid patients. In the state of NY, regionalization of breast cancer care yielded improved outcomes with minimal decrease in access.

Objectives: We evaluated practice trends and 3-year outcomes of transcatheter edge-to-edge repair (TEER) and surgical repair for degenerative mitral regurgitation in the United States., Methods: From the Centers for Medicare and Medicaid Services data (2012-2019), 53,117 mitral valve interventions (surgery or TEER) were performed for degenerative mitral regurgitation, identified by excluding rheumatic and congenital disease, endocarditis, myocardial infarction, cardiomyopathy, and concomitant or prior coronary revascularizations. Median follow-up was 2.9 years (interquartile range, 1.2-5.1 years). End points were 3-year survival, stroke, mitral reinterventions, and heart failure readmissions., Results: Volume of total annual mitral interventions did not significantly change (P = .18) between 2012 and 2019. However, surgical cases decreased by one-third, whereas TEER increased. Among 27,170 patients (52.5% men; mean age, 73.5 years) who underwent TEER (n = 7755) or surgical repair (n = 19,415), surgical patients were younger (71.8 vs 80.8 years; P < .001), with less comorbidity and frailty. In 4532 patient pairs matched for age, frailty, and comorbidity, 3-year survival after TEER was 65.9% (95% CI, 64.3%-67.6%) and 85.7% (95% CI, 84.5%-86.9%) after surgery (P < .001). Three years after TEER or surgery, stroke rates were 1.8% (95% CI, 1.5%-2.2%) and 2.0% (95% CI, 1.6%-2.4%) (P = .49); heart failure readmission rates were 17.8% (95% CI, 16.7%-18.9%) and 11.2% (95% CI, 10.3%-12.2%) (P < .001); and mitral reintervention rates were 6.1% (95% CI, 5.5%-6.9%) and 1.3% (95% CI, 1.0%-1.7%) (P < .001), respectively., Conclusions: Among Medicare beneficiaries with degenerative mitral regurgitation, an increase in TEER utilization was associated with worse survival, increased heart failure readmissions, and more mitral reinterventions. Randomized trials are needed to better inform treatment choice., Competing Interests: Conflict of Interest Statement The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning curves, and time-varying covariates, such as physician experience. To address these limitations, we sought to develop a machine learning (ML) framework to detect and adjust for operator learning effects., Materials and Methods: A gradient-boosted decision tree ML method was used to analyze synthetic datasets that replicate the complexity of clinical scenarios involving high-risk medical devices. We designed this process to detect learning effects using a risk-adjusted cumulative sum method, quantify the excess adverse event rate attributable to operator inexperience, and adjust for these alongside patient factors in evaluating device safety signals. To maintain integrity, we employed blinding between data generation and analysis teams. Synthetic data used underlying distributions and patient feature correlations based on clinical data from the Department of Veterans Affairs between 2005 and 2012. We generated 2494 synthetic datasets with widely varying characteristics including number of patient features, operators and institutions, and the operator learning form. Each dataset contained a hypothetical study device, Device B, and a reference device, Device A. We evaluated accuracy in identifying learning effects and identifying and estimating the strength of the device safety signal. Our approach also evaluated different clinically relevant thresholds for safety signal detection., Results: Our framework accurately identified the presence or absence of learning effects in 93.6% of datasets and correctly determined device safety signals in 93.4% of cases. The estimated device odds ratios' 95% confidence intervals were accurately aligned with the specified ratios in 94.7% of datasets. In contrast, a comparative model excluding operator learning effects significantly underperformed in detecting device signals and in accuracy. Notably, our framework achieved 100% specificity for clinically relevant safety signal thresholds, although sensitivity varied with the threshold applied., Discussion: A machine learning framework, tailored for the complexities of post-market device evaluation, may provide superior performance compared to standard parametric techniques when operator learning is present., Conclusion: Demonstrating the capacity of ML to overcome complex evaluative challenges, our framework addresses the limitations of traditional statistical methods in current post-market surveillance processes. By offering a reliable means to detect and adjust for learning effects, it may significantly improve medical device safety evaluation., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Precision therapies, such as targeted and immunotherapies, have substantially changed the landscape of late-stage non-small cell lung cancer (NSCLC). Yet, utilization of these therapies is disproportionate across strata defined by race and socioeconomic status, possibly because of disparities in molecular diagnostic testing (or biomarker testing), which is a prerequisite to treatment., Methods: We extracted a cohort of NSCLC patients from the Surveillance, Epidemiology, and End Results-Medicare linked data. The primary outcome was receipt of a molecular diagnostic test, based on claims data. The primary predictors were race and socioeconomic status. Likelihood of receiving a molecular diagnostic test and overall survival were investigated using logistic and Cox proportional hazards regression, adjusted for sex, age, residence, histology, marital status, and comorbidity., Results: Of the 28 511 NSCLC patients, 11 209 (39.3%) received molecular diagnostic testing. Compared with White patients, fewer Black patients received a molecular diagnostic test (40.4% vs 27.9%; P < .001). After adjustment, Black patients (adjusted odds ratio [OR] = 0.64, 95% confidence interval [CI] = 0.58 to 0.71) and those living in areas with greater poverty (adjusted OR = 0.85, 95% CI = 0.80 to 0.89) had statistically significant decreased likelihood of molecular diagnostic testing. Patients who did receive testing had a statistically significant decreased risk of death (adjusted hazard ratio [HR] = 0.74, 95% CI = 0.72 to 0.76). These results held in the stratified analysis of stage IV NSCLC patients., Conclusion: Disparities exist in comprehensive molecular diagnostics, which is critical for clinical decision making. Addressing barriers to molecular testing could help close gaps in cancer care and improve patient outcomes., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: Multimodal pain management aims to concurrently target several pain pathways for improved treatment efficacy and recovery. We investigated associations between multimodal analgesia use and postoperative complications, length of hospital stay (LOS), and opioid consumption among patients undergoing coronary artery bypass graft surgery., Methods: This retrospective cohort study included 349,940 adult patients undergoing elective coronary artery bypass graft surgery (January 2006 to December 2019), from the national Premier Healthcare claims dataset. The study intervention was multimodal analgesia, defined as opioid use with the addition of nonopioid analgesic modalities. These included, nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 inhibitors, paracetamol/acetaminophen, neuraxial anesthesia, steroids, gabapentin/pregabalin, and ketamine. Analgesic management was stratified into 4 categories: opioids only and multimodal analgesia with the addition of 1, 2 or ≥3 nonopioid analgesic modalities. Mixed-effects regression models measured associations between multimodal analgesia and postoperative complications, LOS, and opioid consumption measured in milligram oral morphine equivalents., Results: Multimodal analgesia was associated with a beneficial dose response pattern. With increasing nonopioid analgesic modalities added to opioid analgesia, a stepwise decrease in complication risk was consistently observed, eg, with the addition of 1, 2, or ≥3 nonopioid modalities the odds for any complication decreased by 8% (odds ratio [OR], 0.92; confidence interval [CI], 0.90-0.94), 17% (OR, 0.83; CI, 0.81-0.86), and 22% (OR, 0.78; CI 0.69-0.79), respectively. This stepwise pattern was consistent in respiratory, cardiac, and renal complications individually. Similarly, LOS decreased stepwise with added analgesic modalities., Conclusions: These nationally representative data indicate that enhanced pain management by multiple pain pathways is associated with significant reductions in postoperative complications and shortened patient recovery., Competing Interests: Conflict of Interest Statement S.G.M. has a US patent application for a Multicatheter Infusion System (US-2017-0361063) and is the owner of SGM Consulting, LLC. He is a partner in Parvizi Surgical Innovations, LLC. None of the aforementioned relations influenced the conduct of the present study. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Omalizumab was recently approved by the US Food and Drug Administration for treatment of any single food allergy or multiple food allergies in children aged 1 year and older and adults. There is currently no formal guidance regarding recommended best practices for omalizumab use in food allergy, including patient selection, anticipated goals and outcomes of therapy, procedure for monitoring patients who elect to start omalizumab therapy, and ways in which omalizumab can be incorporated into the landscape of food allergy management and daily clinical practice. This work group report was developed by the food allergy therapies subcommittee of the Adverse Reactions to Foods Committee within the American Academy of Allergy, Asthma & Immunology. Consensus, evidence-based guidance regarding experts' recommendations for using omalizumab to treat children and adults with food allergy was developed by using modified Delphi methodology. In iterative fashion, a total of 8 statements regarding how to use omalizumab to treat patients with food allergy were developed by 16 clinical experts. This guidance provides the clinician with a suggested approach to patient selection, initiation of therapy, monitoring of efficacy, and long-term follow-up care. The role of preference-sensitive care is emphasized, with most statements offering care recommendations relevant to the culture and values of a particular practice setting., Competing Interests: Disclosure statement Disclosure of potential conflict of interest: A. Anagnostou reports institutional funding from Novartis; advisory board service for of Genentech, Novartis, Bryn, and Ready, Set, Food!; and consultation/speaker fees from ALK, Adelphi, Bryn, Novartis, Genentech, Medscape, Food Allergy Research and Education (FARE), MHJ, and EPG Health. J. A. Bird reports consultancy for Allergenis, DBV Technologies, FARE, Genentech, Hanimmune Therapeutics, HAL Allergy, Infinant Health, Novartis, Nutricia, and Parexel, as well as research for Aimmune, DBV Technologies, Genentech, the National Institute of Allergy and Infectious Diseases (NIAID), Novartis, Regeneron, and Siolta. S. Chinthrajah receives grant support from the Consortium for Food Allergy Research (CoFAR), NIAID, and FARE and is an advisory board member for Alladapt, Novartis, Allergenis, IgGenix, Intrommune Therapeutics, Phylaxis, and Genentech. T. E. Dribbin has received funding and is supported by NIH (K23 AI175525). D. M. Fleischer has received research support from ARS Pharmaceuticals and DBV Technologies; serves as an unpaid advisory board member for the Food Allergy and Anaphylaxis Connection Team and the National Peanut Board; receives royalties from UpToDate; and has received personal fees as a consultant to Aquestive, ARS Pharmaceuticals, Bryn Pharma, DBV Technologies, Genentech, and Nasus outside the submitted work. E. Kim reports grants to his institution from NIAID and FARE; personal fees from ALK, Ukko, Cellergy Pharma, DBV Technologies, Genentech, Hanimumme Therapeutics, Novartis, Phylaxis, Revolo Biotherapeutics; and safety review board service for Allergy Therapeutics. A. Nowak-Wegrzyn receives research support from NIAID, DBV Technologies, and Siolta Therapeutics; speaking fees from Nestle, Danone, Medscape, and Genentech; and royalties from UpToDate. In addition, A. Nowak-Wegrzyn serves as an associate editor for the Annals of Allergy, Asthma and Immunology; as director of the AAAAI board; and as chair of the medical advisory board of the International Food Protein Induced Enterocolitis Syndrome Association. M. S. Shaker is a member and cochair of the Joint Task Force on Practice Parameters, serves on the editorial board of The Journal of Allergy and Clinical Immunology: In Practice, is an associate editor of Annals of Allergy, Asthma & Immunology, and serves on the board of directors of the AAAAI (all views expressed are his own). W. Shreffler reports grants to his institution from NIAID, the Food Allergy Science Initiative, and FARE; contract research support to his institution from Genentech, DBV, Allergy Therapeutics, Aravax, Novartis; personal consulting fees from Aimmune, DBV, Novartis, ALK, Allergy Therapeutics, FARE; and royalty payments from UpToDate. S. Sicherer reports royalty payments from UpToDate and Johns Hopkins University Press; grants to his institution from tNIAID, FARE, and Pfizer; and personal fees from the AAAAI as deputy editor of the Journal of Allergy and Clinical Immunology: In Practice outside of the submitted work. B. P. Vickery reports grants from Alladapt, AstraZeneca, Genentech, NIAID, and Siolta; personal fees from Allergenis, Aravax, Reacta Biosciences, and Sanofi Regeneron; both grants and personal fees from Aimmune, DBV, FARE, Novartis, and Regeneron; and stock options from Moonlight Therapeutics outside the submitted work. J. Wang is a member of the Joint Task Force on Practice Parameters; receives research support from NIAID, Aimmune, DBV, and Siolta; and receives consultancy fees from ALK-Abelló, DBV, and Novartis. M. Greenhawt is a consultant for Aquestive; is a member of physician/medical advisory boards for DBV Technologies, Takeda, Griffols, Nutricia, Novartis, Aquestive, Allergy Therapeutics, AstraZeneca, ALK-Abelló, Bryn, Genentech, and Prota; is a speaker for Genentech; is an unpaid member of the scientific advisory council for the National Peanut Board and medical advisory board of the International Food Protein–Induced Enterocolitis Syndrome Association; is a member of the Brighton Collaboration Criteria Vaccine Anaphylaxis 2.0 working group; is the senior associate editor for the Annals of Allergy, Asthma, and Immunology; and is member of the Joint Taskforce on Allergy Practice Parameters. In addition, J. Wang has received honoraria for lectures from ImSci, Red Nucleus, Medscape, Paradigm Medical Communications, Kaplan, Food Allergy Research and Education, and multiple state and local allergy societies. The rest of the authors declare that they have no relevant conflicts of interest., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Posttraumatic stress disorder (PTSD) has become a main psychological consequence of COVID-19. This study assessed the association between social support, psychological resilience, and probable COVID-19-related PTSD., Methods: The PTSD Checklist for DSM-5, Medical Outcomes Study Social Support Survey, and Connor-Davidson Resilience Scale (CD-RISC) were used to assess for PTSD symptoms, social support, and resilience among COVID-19 patients treated at a large medical system in New York City between July 2020 and July 2023. Logistic regression evaluated the association between social support and resilience with PTSD. We further investigated whether associations differed across age, gender, site of acute care, vaccination status, and pre-existing mental disorders., Results: Among the 1484 participants, 16.6 % had probable COVID-19-related PTSD. Higher scores on measures of resilience (OR: 0.68, 95 % CI: 0.61-0.75) and social support (OR: 0.96, 95 % CI: 0.93-0.99) were associated with lower odds of probable COVID-19-related PTSD. The association between resilience and PTSD was moderated by sex (p for interaction = 0.001), with resilience showing a stronger negative association with PTSD among men relative to women. Associations between resilience, social support, and COVID-19-related PTSD did not differ by age, sites of acute care, vaccination status, and pre-existing mental disorders., Limitations: Cross-sectional design precludes establishing causal relationships; assessment timing was not considered; the short CD-RISC may limit measurement precision; single-center study may not be fully generalizable., Conclusions: These findings suggest that individuals with low social support and resilience may be at higher risk of PTSD and should be screened and be the target of preventive interventions., Competing Interests: Declaration of competing interest Juan Wisnivesky received consulting honorarium from Sanofi, PPD, and Banook and grants from Sanofi, Regeneron, and Axella. Dr. Feder is named co-inventor on issued patents in the US and outside the US filed by the Icahn School of Medicine at Mount Sinai related to the use of ketamine for the treatment of PTSD. This intellectual property has not been licensed. The other authors report no conflict of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Evidence is lacking regarding the benefits of pulmonary artery catheter (PAC) for cardiogenic shock (CS)., Methods: We analyzed the data on Medicare fee-for-service beneficiaries aged 65-99 admitted with CS from 2016 to 2020 to compare outcomes of patients monitored with versus without PAC. We implemented propensity score matching weight (PSMW) analysis with hospital fixed effects (effectively comparing outcomes within the same hospital) and quasi-experimental instrumental variable (IV) analysis (accounting for potential unmeasured confounders) with the probability of using PAC for CS in the previous year as the instrument., Results: We included 4668 and 78,502 patients admitted with CS, monitored with and without PAC, respectively. We found no evidence that the use of PAC was associated with mortality either in PSMW (adjusted absolute risk difference [aRD], +0.5-percentage-points [pp]; 95 % confidence interval [CI], -1.1 to +2.1) or IV (aRD, -2.5 pp.; 95 % CI, -8.2 to +3.2) analyses. While consistent associations were not observed between the use of PAC and major bleeding and sepsis, the use of PAC was associated with a higher risk of all-bleeding (PSMW: aRD, +1.5 pp.; 95 % CI, +0.1 to +2.9; IV: +13.3 pp.; 95 % CI, +7.7 to +18.8) and longer LOS (PSMW: adjusted mean difference, +1.6 days; 95 % CI, +1.1 to +2.0; IV: +6.9 days; +4.9 to +9.0)., Conclusions: We found no evidence that the use of PAC was associated with lower mortality in patients with CS. While high-quality randomized trials are needed, providers should be careful about appropriate settings and indications of the use of PAC for the management of CS., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Since the 1980s, the four skills criteria have become the most widely accepted mechanism for the assessment of decisional capacity in the United States. These criteria emerged in response to the paternalistic approach to clinical decision-making that had been widely accepted in an earlier era and offered a means of ensuring that physicians honored the rights of capacitated patients to make their own medical decisions. Unfortunately, the criteria are now applied to situations for which they are not suited and in a manner that is often highly inflexible. In an article in this issue of The Journal, Matthew Dernbach and colleagues describe one potential scenario that requires a flexible approach to using the four skills model: situations in which a patient stands at high risk of losing decisional capacity in the near future. Using Dernbach et al. as a starting point, this article offers specific ways in which the four skills model can be improved upon or augmented without abandoning its key principles. These advances include adjusting to empirical evidence, re-emphasizing the importance of autonomy maximization and restorability, and embracing novel conceptual and technological innovations., (© 2024 American Academy of Psychiatry and the Law.)

Preliminary research shows the psychedelic psilocybin to be a promising potential treatment for psychiatric illnesses. Recent U.S. government legislation and policy indicate that access to psilocybin, which remains illegal on the federal level despite increasing efforts to decriminalize it at the state and local levels, will be expanded to enable further research into its treatment potential. It remains unclear how psilocybin will be regulated and who will have access to this new treatment, raising important legal and ethics questions psychiatrists must consider. This article reviews the current legal regulation of psilocybin and matters related to standard of care, right to effective treatment, and the respectable minority doctrine. It concludes with a discussion of the ethics matters surrounding the use of psilocybin as medicine, including provider bias, the interpersonal dynamic between providers and patients, informed consent, and equity and access., (© 2024 American Academy of Psychiatry and the Law.)

Objective: To estimate the effect of growth in gynecologic oncology fellowships in the United States on surgical volume for trainees and practicing gynecologic oncologists over the next 20 years., Methods: Using 2010-2019 age-specific gynecologic cancer incidence estimates from US Cancer Statistics, significant changes in incidence were identified with Joinpoint software. Statistically significant changes in annual rates were projected forward five years, and these estimates were used to generate projections of cancer cases in the population from the U.S. The number of practicing gynecologic oncologists was projected through 2045 based on current fellowship enrollment. For sensitivity analysis, we varied the number of new fellows and fellowships based on data trends from the last five years., Results: Over the next 20 years, cancer cases will increase by 14 % with the majority being endometrial. With current trainee numbers, the average annual number of new surgical cancer patients per practicing gynecologic oncologist will decrease from 73 to 51 (30 % decrease). An increase of one fellow per year nationally to the total number of trainees will further decrease new surgical cancer cases to 43 cases/gynecologic oncologist annually (41 % decrease). When accounting for one additionally trainee nationally per year over the next 20 years, the average number of oncologic surgical cases per fellow/year will decrease from 208 to 160 (23 % decrease). Under the assumption of no additional fellowship positions, surgical cases will increase from 208 to 226 per fellow/year (9 % increase)., Conclusion: The gynecologic cancer caseload of practicing gynecologic oncologists is estimated to decrease by nearly 41 % and trainee case volume will drop by 23 % over the next 20 years with minimal continued addition of training positions. Careful consideration should be given to creating an appropriate balance between the number of practicing gynecologic oncologists, potential dilution of programs' case volume per trainee, and the effects on the needs of future patients., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The only disclosure is that Dr. Stephanie Blank is on the ABOG division of gynecologic oncology committee., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: Based on a potential shared pathophysiology tied to mast cell activity and neurogenic inflammation that may link pruritus and chronic cough (CC), this study, leveraging the All of Us database, examines the association between the two conditions., Materials and Methods: A nested case-control comparison was used to examine the association, identifying cases with SNOMED codes 418363000 (pruritus) and 68154008 (CC). Matching was performed on a 1:4 ratio by age, sex, and ethnicity using the MatchIt package in R, followed by maximum likelihood method to estimate odds ratios (ORs) and 95% confidence intervals from 2x2 contingency tables., Results: CC patients ( n  = 2,388) were more than twice as likely to be diagnosed with pruritus (OR: 2.65) and pruritus patients ( n  = 22,496) were more than twice as likely to be diagnosed with CC (OR: 2.57), than respective matched controls., Conclusions: These results highlight the potential bidirectional relationship between CC and pruritus, suggesting possible shared immune and neural pathways. Treatments like difelikefalin and nalbuphine that modulate these pathways, alongside P2X3 targeting agents, are emerging as potential therapeutic approaches for itch and chronic cough given the possible interconnected pathophysiology. This study's insights into the associations between pruritus and CC may pave the way for targeted therapeutic strategies that address their shared mechanisms.

Purpose: The purpose of this study was to investigate the impact of demographic characteristics and psychiatric comorbidity on the prevalence of dry eye disease in the American geriatric population., Methods: Data were collected from a 2011 nationwide sample of Medicare beneficiaries aged 65 years and older (N = 1,321,000). Age, sex, race/ethnicity, residential area, climate region, and income, along with psychiatric comorbidities including depression and anxiety, were collected. Multivariable logistic regression models were used to assess the relationship between demographic and psychiatric factors and the prevalence of dry eye disease., Results: Among 21,059 patients with clinically significant dry eye, women had higher odds of having dry eye compared with men [odds ratio (OR) 2.03, 95% confidence interval (1.97-2.10)]. Asian and Native American patients had increased odds of having dry eye compared with White patients [OR 1.85 (1.69-2.02) and OR 1.51 (1.19-1.93)], while Black patients were less likely to have dry eye [OR 0.83 (0.79-0.87)]. Patients aged 75 to 84 years and 85+ were more likely to have dry eye compared with those aged 65 to 74 years [OR 1.49 (0.45-1.53) and OR 1.54 (1.48-1.60)]. Having both depression and anxiety were associated with higher odds of having dry eye [OR 2.38 (2.22-2.55)] compared with having depression alone [OR 1.95 (1.86-2.04)] or anxiety alone [OR 2.22 (2.10-2.35)]., Conclusions: Significant racial and regional disparities in dry eye prevalence were found. Psychiatric association with dry eye varied with age, sex, race, and residence region. Further research is needed to comprehend the underlying mechanisms, implications, and to address disparities in the diagnosis and management of dry eye., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The All of Us Research Program aims to return value to participants by developing research capacity in communities. We describe a novel set of introductory exercises (Data Sandboxes) and specialized trainings to orient researchers to the Researcher Workbench to foster health equity research., Materials and Methods: We developed a tailored training to familiarize researchers with the All of Us Research Program: (1) orientation, (2) tailored "data treasure hunt" using the Public Data Browser, and (3) overview of the analyses tools and platform., Results: Participants' pre- and post-knowledge of the contents and structure of the All of Us dataset scores increased significantly after training. These trainings effectively engaged researchers in exploring this rich dataset., Conclusion: We describe ways of orienting and familiarizing a wide variety of researchers with the All of Us Research Program dataset, sparking their interest, and "jump-starting" their research., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Percutaneous microaxial ventricular assist devices (pVADs) have the potential to reduce mortality of patients with cardiogenic shock (CS). However, the association between the distribution of pVAD-performing centers and outcomes of CS has not been explored., Methods: This observational study included Medicare fee-for-service beneficiaries aged 65 to 99 years treated with pVAD for CS from 2016 to 2020. It examined the associations between patient outcomes and 2 exposure variables: hospitals' procedure volumes of pVAD and patient-hospital distances (in quintiles [Qn]). We developed Cox proportional hazards regression for 180-day mortality and heart failure readmission rates, and multivariable logistic regression for in-hospital outcomes, adjusting for patient demographics, comorbidities, concomitant treatments, and hospital characteristics, including CS volume, teaching status, and the ability to perform extracorporeal membrane oxygenation., Results: A total of 6637 patients with CS underwent pVAD at 1041 hospitals, with the annualized hospital volume ranging widely from 0.3 to 55.6 cases/year. Patients treated at higher-volume centers experienced lower 180-day mortality compared with those treated at lower-volume centers (Qn1=reference; Qn2: adjusted hazard ratio [aHR], 0.88 [95% CI, 0.79-0.97]; Qn3: aHR, 0.88 [95% CI, 0.79-0.98]; Qn4: aHR, 0.88 [95% CI, 0.78-0.99]; Qn5: aHR, 0.84 [95% CI, 0.74-0.95]; P for trend, 0.026), while we found no evidence that patient-hospital distances were associated with mortality (Qn1=reference; Qn2: aHR, 0.99 [95% CI, 0.89-1.09]; Qn3: aHR, 0.94 [95% CI, 0.85-1.04]; Qn4: aHR, 1.01 [95% CI, 0.92-1.11]; Qn5: aHR, 0.91 [95% CI, 0.82-1.01]; P for trend, 0.160). We found no evidence that the hospital volume and patient-hospital distances were associated with in-hospital bleeding, intracranial hemorrhage, or renal replacement therapy initiation., Conclusions: Hospital volume was more strongly associated with mortality than patient-hospital distances, suggesting that rational distribution of pVAD-performing centers while ensuring adequate procedure volumes may optimize patient mortality., Competing Interests: Dr Kapur has received consulting/speaker fees from Abbott, Abiomed, Boston Scientific, Edwards, Getinge, LivaNova, Teleflex, and Zoll; and has received consulting honoria and institutional research grants from Abbott, Abiomed, Boston Scientific, Getinge, LivaNova, and Teleflex. Dr Jorde is a consultant for Abbott, Edwards Lifesciences, and Ancora Heart (no honoraria). Dr Tsugawa reported serving on the board of directors for M3, Inc.The other authors report no conflicts.

Hypothesis/purpose: Mountain biking (MTB) is a quickly growing sport, with fractures being the most common injury among MTB athletes. Currently, there is a lack of analysis of MTB fractures based on emergency department (ED) data obtained on a national scale. It was hypothesized that the total number of fractures presenting to United States (US) EDs increased significantly over the last decade, and adult male riders experienced higher rates of fracture and fracture-related hospitalization than other demographics., Methods: All data was extracted from the National Electronic Injury Surveillance System (NEISS), a public database representing approximately 100 US EDs. NEISS was queried for all MTB-related fractures from January 1st, 2013-December 31, 2022., Results: NEISS returned a national estimate (NE) of 35,260 MTB fractures visiting EDs between 2013 and 2022. Fracture injuries increased significantly over the study period, including a 247 % increase from 2019 to 2020. The mechanism of injury most likely resulting in fracture was being thrown from the bike (39.6 %, NE:5,436). The upper extremity was the most commonly fractured body region (32.8 %, NE:11,574), and trunk fractures had the highest rate of hospitalization (44.2 %, NE:3705). Males accounted for the majority of fractures (87.9 %, NE:30,996), and were more likely to be hospitalized than females (22.2 %>17.4 %). Adults (age≥40) were more likely to sustain a fracture (48.8 %) and be hospitalized because of it (25.8 %) than other age groups. Adults were also most likely to fracture their trunk (33.9 %)., Conclusion: MTB fractures increased significantly from 2013 to 2022, possibly due to the gaining popularity of MTB since COVID-19. The upper extremity was the most frequently fractured body region, and being thrown from the bike was the mechanism most likely to result in a fracture. Adult male riders are at a high risk for trunk fractures, demonstrating the importance of protective equipment such as chest and torso protectors for these athletes., Level of Evidence: III., Competing Interests: Declaration of competing interest none, (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Objective: To characterize the awareness of, adherence to, and barriers to the 2017 National Institute of Allergy and Infectious Diseases (NIAID) peanut allergy prevention guidelines among the pediatrics health care workforce., Study Design: Pediatricians, family physicians, advanced practice providers (APPs), and dermatologists who provide care for infants were solicited for a population-based online survey, administered from June 6, 2022, through July 3, 2022. The survey collected information about NIAID guideline awareness, implementation, and barriers as well as concerns related to the guidelines., Results: A total of 250 pediatricians, 250 family physicians, 504 APPs, and 253 dermatologists met inclusion criteria. Self-reported guideline awareness was significantly higher for pediatricians (76%) compared with dermatologists (58%), family physicians (52%), and APPs (45%) (P < .05). Among participants who were aware of the guidelines, most reported using part or all of the guidelines in their clinical practices. Reported practice patterns for peanut introduction in 6-month-old infants were variable and did not always align with guidelines, particularly for infants with mild-to-moderate atopic dermatitis., Conclusions: Although pediatricians have the highest self-reported level of NIAID guideline awareness, awareness was suboptimal irrespective of provider type. Education for all pediatric clinicians is urgently needed to promote evidence-based peanut allergy prevention practices., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: In 2023, the U.S. Veterans Health Administration convened a State of the Art meeting to evaluate the existing evidence and make recommendations for measuring the well-being of the whole person in clinical care, health research, and population health evaluation. In this article, we describe findings and recommendations concerning each of these health care system functions, as well as key takeaways from the meeting as a whole., Background: There has been a growing call for health care organizations to expand their focus beyond disease-based concepts to consider both positive aspects of health and indicators of well-being that extend beyond the health domain. Yet, knowledge remains limited regarding how best to integrate these types of measurements in clinical care, health research, and population health evaluation efforts., Method: State of the Art activities were organized into 3 workstreams, each focused on a core health care system function (clinical care, health research, and population health evaluation). Drawing from existing literature on the measurement of the well-being of the whole person in the assigned health care function, workgroups evaluated the existing state of knowledge and made recommendations for future work on well-being measurement in the health care setting., Results: Cross-cutting themes included: (1) difficulty evaluating the current state of knowledge due to varied use of terminology in this literature; (2) appreciation for the value of well-being measurement in each health care function; (3) need for additional research on the use and benefits of well-being measures, including their role as predictors and moderators of health and health care outcomes; (4) importance of ensuring that measures are applicable for diverse patient groups and adequately reflect the "patient voice;" and (5) need for additional leadership investment and resource allocation to support use of these measures in the health care setting., Conclusions: Knowledge from this meeting can be applied to enhance the use and application of measurement of well-being to improve patients' health and health care outcomes., Competing Interests: The authors declare no conflict of interest.

Objective: To estimate the prevalence of the Vice Chair of Education (VCE) role in obstetrics and gynecology (OBGYN) departments and to describe the demographics, responsibilities, resource allocation, and challenges faced by individuals in this role., Design: A 2-part survey was developed with the Association of Professors of Gynecology and Obstetrics (APGO) Member Engagement Workgroup., Setting: National survey., Participants: Part 1 was sent to OBGYN department chairs to identify departments with a VCE and to assess characteristics of departments without 1. Part 2 was sent directly to VCEs to assess characteristics of the department and the individual VCE, including demographics, academic appointments, leadership and educational experience, responsibilities, and institutional support. Chi-squared tests were used to compare departments with and without VCE., Results: 196 of 256 OBGYN chairs (76.5%) responded to part 1 of the survey, and 71 of 86 VCEs (82.5%) responded to part 2 of the survey. The prevalence of the VCE role was 43.9%. Departments with a VCE had larger numbers of faculty, residents, and medical students, and were more likely to identify as university-affiliated (all p < 0.001). A majority of VCEs identified as women (82.1%), associate professors (55.0%), and academic specialists (51%), with 62.3% serving as the inaugural VCE in their department. Approximately half of VCEs have a defined job description, and only 35.8% controlled an educational budget. Two-thirds (65.7%) of VCEs received full-time equivalent (FTE) support for the role, with 37.1% receiving 0.2 FTE., Conclusions: The VCE role remains relatively new in OBGYN. Optimizing success of individuals in this role requires increased job clarity, adequate support, and ongoing opportunities for career development., (Copyright © 2024 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The association between ultra-processed food (UPF) intake and markers of biological ageing has been scarcely investigated, despite the evident adverse health effects associated with UPF. This study aimed to test the association between UPF intake and biological ageing, and evaluate how much of this association is accounted for by overall diet quality., Methods: This cross-sectional study assessed 16 055 participants aged 20-79 years (51% women, 46 ± 0.3 years) from the National Health and Nutrition Examination Survey (NHANES) 2003-2010. Dietary UPF intake was assessed using the Nova system. Values were expressed as % of total energy intake and were denominated as a continuous variable and in quintiles. Diet quality was assessed with the American Heart Association 2020 and the Healthy Eating Index 2015. Biological ageing was assessed using the PhenoAge algorithm., Results: For each 10% of energy intake accounted for by UPF, participants were 0.21 (95%CI 0.16-0.26) years biologically older in terms of PhenoAge. As compared to participants in the lowest UPF quintile (≤39%), those in the highest UPF quintile (68-100%) were 0.86 (95% CI 0.55, 1.16) years older (P-for-trend across quintiles ≤0.001). Adherence to a healthy diet moderately attenuated the relationship between UPF and PhenoAge (adjusted β = 0.14 per 10% increment of UPF)., Conclusions: Adults with higher UPF tended to be biologically older. This association is partly independent of diet quality, suggesting that food processing may contribute to biological ageing acceleration. Our findings point to a compelling reason to target UPF consumption to promote healthier ageing., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Geriatrics Society.)

Abstract: Acquired hemophilia A (AHA) is an autoimmune bleeding disorder that is caused by factor VIII (FVIII) autoantibodies with high morbidity and mortality due to bleeding and complications from immunosuppression (IST). To address the real-world implications of the FVIII mimetic antibody, emicizumab, and the role of IST, we retrospectively collected de-identified data on 62 patients with AHA who were treated off-label with emicizumab for a median of 10 weeks at 12 US-based hemophilia treatment centers. Most patients (95.2%) had acute bleeding at diagnosis, and 62.9% had partial or no control of bleeds despite the use of hemostatic agents at the time emicizumab was started. The main reason for initiating emicizumab was outpatient bleeding prophylaxis. After initiation of emicizumab, 87.1% had no additional bleeds. There were 6 breakthrough bleeds (2 spontaneous) in 5 patients and no fatal bleeding events during maintenance emicizumab treatment. The mean breakthrough bleed rate per patient-week was 0.02 (95% confidence interval, 0.0-0.03) during the first 12 weeks of emicizumab for the 55 patients with at least 12 weeks of follow-up. Of these patients, 92.7% received IST and 74.5% were prescribed rituximab-based regimens. Complete resolution of inhibitor and normalization of FVIII levels occurred in 56% overall and in 63% of the patients treated with rituximab. Overall, the median time to discontinuation of emicizumab and IST was 18 weeks. Two patients had thrombotic events while on emicizumab, but no adverse events were attributed to emicizumab and there were no infections attributed to IST. Emicizumab provides effective outpatient bleeding prophylaxis for AHA, and concurrent IST may further mitigate bleeding., (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)

Purpose: We sought to investigate the disease characteristics, treatment patterns, and survival outcomes of upper urinary tract squamous cell carcinoma (UT-SCC) using the National Cancer Database (NCDB)., Methods: The NCDB was queried for UT-SCC patients from 2004 to 2020. Patients with upper tract urothelial carcinoma (UTUC) were also identified for comparison with UT-SCC. Baseline characteristics were compared between UT-SCC and UTUC patients. Kaplan-Meier analysis assessed stage-based differences in median overall survival (mOS) between 1:4 propensity-matched cohorts of UT-SCC and UTUC patients. Predictors of mortality were assessed via multivariate cox regression., Results: 644 cases of UT-SCC and 55,994 cases of UTUC were identified. Compared to UTUC, UT-SCC patients were more likely to have a higher TNM stage, lymphovascular invasion, and positive surgical margins. UT-SCC demonstrated a comparable mOS to UTUC for non-metastatic T1-T2 disease (74.84 vs. 106.38 months, p = 0.353) and metastatic disease (5.62 vs. 7.16 months, p = 0.058). However, UT-SCC carried a poorer prognosis for carcinoma in situ (45.14 vs. 69.32 months, p = 0.032) and non-metastatic T3-T4 disease (13.63 vs. 31.93 months, p < 0.001). Moreover, we found increasing T stage, metastatic disease, and positive surgical margins to be significant predictors of UT-SCC mortality. Lastly, we found that surgery does not confer a survival benefit over other management strategies for metastatic UT-SCC., Conclusions: UT-SCC is a rare, aggressive malignancy that typically presents with a more advanced stage than UTUC. Surgical margin status may represent one of the most salient predictors of UT-SCC mortality. Further studies are needed to best define treatment strategy for this uncommon malignancy., Competing Interests: Declarations. Ethical approval: Our study was deemed exempt from review from our institutional review board as it is a retrospective study using de-identified data from a national database. Competing interests: The authors have no relevant financial or non-financial interests to disclose., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Aims: Epidemiological studies show that despite the episodic nature, the long-term trajectory of depression can be variable. This study evaluated the heterogeneity of 10-year trajectory of major depressive disorder (MDD) related service utilization and associated clinical characteristics among US Veterans with a first diagnosis after 9/11., Methods: Using a cohort design, electronic health record data for 293,265 Operation Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans were extracted to identify those with MDD between 2001 and 2021 with a full preceding year of clinical data and 10 years following the diagnosis. Latent class growth analysis compared clinical characteristics associated with four depression trajectories. Across all Veterans Affairs (VA)hospitals, 25,307 Veterans met our inclusion criteria. Demographic and clinical information from medical records was extracted and used as predictors of depression 10-year trajectories., Results: Among the study cohort ( N  = 25,307), 27.7% were characterized by brief contact, 41.7% were later re-entry, 17.6% were persistent contact and 12.9% were prolonged initial contact for depression related services. Compared to Veterans with trajectories showing brief contact, those with protracted treatment (persistent or prolonged initial contact) were more likely to be diagnosed with comorbid posttraumatic stress disorder (PTSD) and with MDD that was moderate to severe or recurrent., Conclusions: Depression is associated with a range of treatment trajectories. The persistent and prolonged initial contact trajectories may have distinct characteristics and uniquely high resource utilization and disability income. We can anticipate that patients with comorbid PTSD may need longer-term care which has implications for brief models of care.

Objective: Maternal iodine plays a central role in fetal neurodevelopment. It is recommended that pregnant women consume sufficient levels of iodine to accommodate increased need for mother and fetus. We examined associations among prenatal dietary and supplemental iodine intake and infant temperament., Design: The PRogramming of Intergenerational Stress Mechanisms (PRISM) study is an ongoing longitudinal pregnancy cohort. Data from 2011 to 2020 were used for this study. Women completed the Block98 FFQ ascertaining prenatal dietary and supplemental iodine intake and the Infant Behavior Questionnaire-Revised at infant age 6 months to ascertain infant temperament (Surgency/Extraversion, Negative Affectivity and Orienting/Regulation)., Setting: USA., Participants: Mother-child dyads ( n 892)., Results: Women were primarily Black/Hispanic Black (44 %) and non-Black Hispanic (35 %) with 46 % reporting household income < $25 000/year. Nearly half had an estimated average requirement (EAR) < 160 µg/d (49 % based on dietary intake; 43 % based on diet and supplements). Girls born to women with an EAR ≥ 160 µg/d compared to girls born to women below this level had higher unadjusted extraversion scores for dietary plus supplemental intake ( β = 0·23 (0·13, 0·33)); decreased to β = 0·05 (-0·08, 0·19) after adjusting for covariates. Boys born to women with an EAR ≥ 160 µg/d (based on diet and supplements) as compared to boys born to women below this level had statistically non-significant higher unadjusted negative affective score ( β = 0·06 (-0·08, 0·20)) that became significantly lower upon covariate adjustment ( β = -1·66 (-1·97, -1·35))., Conclusions: A significant proportion of these women reported suboptimal prenatal iodine intake. Suboptimal prenatal iodine intake may have implications for child neurodevelopment evident as early as infancy.

Introduction: Opioid overdose deaths in the U.S. have risen dramatically in the past decade, largely due to the surge in illicitly manufactured fentanyl. Injection drug use is a known risk factor for HIV, further complicating the long-term consequences of opioid use. The baseline prevalence of HIV among adults in the US is 0.46 %. The primary purpose of this study was to determine the prevalence and risk factors of HIV among patients presenting to the emergency departments (ED) with an acute opioid overdose., Methods: This study is a prospective observational cohort study from the ToxIC Fentalog Study group. Patients age 18 years of age or older are included if they present to one of 10 participating U.S. hospitals in 9 states between September 2020 and May 2023 with a suspected opioid overdose and had waste serum available after routine laboratory testing. Clinical data is collected from the medical record and patient serum is sent for comprehensive toxicologic analysis via liquid chromatography quadrupole time-of-flight mass spectroscopy to detect the presence of over 1200 substances including illicit opioids, novel synthetic opioids, medications, and adulterants. Logistic multivariable regression was performed to examine the association between demographic, behavioral, and serum toxicology data with risk factors and HIV status., Results: Among the total cohort (n=1690), 1062 cases had known HIV status (62.8 % of total sample). Among patients with a known HIV status, 60 (5.6 % [95 % CI: 4.2 %, 7.0 %]) were HIV positive. Patients with HIV reported stimulant use more frequently (13.3 %) than those without HIV (6.8 %; p=0.003). After controlling for confounding, bipolar psychiatric history was a significant independent predictor of HIV positivity (aOR: 1.08; 95 % CI: 1.02, 1.13) in this population., Conclusions: In this large multicenter cohort, the prevalence of HIV for ED patients with illicit opioid overdose was 9 times higher than that expected by the general population. Bipolar disorder appears to be a novel risk factor for HIV positivity in this patient population., Competing Interests: Declaration of Competing Interest There are no financial, litigational, or other conflicts of interest to disclose., (Copyright © 2024. Published by Elsevier B.V.)

Background: The Wound Care Collaborative Community (WCCC) aims to assess current usable real-world data (RWD) sources to determine which real-world databases (DBs) are suitable and usable for studying the natural history of chronic wounds. Randomized controlled trials (RCTs) do not fully reflect the complexity of patients with chronic wounds. Using RWD, establishment of a scientifically grounded "road map" for RCTs is needed to better navigate the real-world complexity of the patients with chronic wounds. The long-term objectives include identifying patients ineligible to receive evidence-based advanced treatment and diagnostic options, reducing patient suffering, and providing decision support for regulatory bodies, payers, and clinicians., Objective: To identify available and usable RWD on US chronic wound care patients, as an early step toward the WCCC's objectives., Methods: Using B.R.I.D.G.E. TO DATA® methodology, the WCCC conducted a comprehensive RWD landscape analysis and systematically screened 34 potential sources for chronic wounds. Multiple data elements helped determine suitability and usability., Results: Four clinical US DBs have "high potential" for elucidating the natural history of chronic wounds; a fifth met the WCCC criteria but has data access restrictions., Conclusion: Identifying suitable, usable real-world DBs for research is complex. Only 1 DB was found that is fit for purpose and matches the goals to study the natural history of patients with chronic wounds.

Objective: To describe sex differences in concussion characteristics in US Service Academy cadets., Design: Descriptive epidemiology study., Setting: Four US service academies., Participants: 2209 cadets (n = 867 females, n = 1342 males)., Independent Variable: Sex., Outcome Measures: Injury proportion ratios (IPR) compared the proportion of injuries by sex (females referent) for injury situation, certainty of diagnosis, prolonged recovery, recurrent injuries, mental status alterations, loss of consciousness (LOC), posttraumatic amnesia (PTA), retrograde amnesia (RGA), motor impairments, delayed symptom presentation, and immediate reporting., Main Results: Concussions from varsity/intercollegiate sports [IPR of 1.73, 95% confidence interval (CI) 1.43-2.10] and intramurals (IPR of 1.53, 95% CI 1.02-2.32) accounted for a larger proportion in males, whereas concussions outside of sport and military activities accounted for a smaller proportion among males (IPR of 0.70, 95% CI 0.58-0.85). The proportion of concussions with prolonged recovery was lower among males (IPR of 0.69, 95% CI 0.60-0.78), while concussions with altered mental status (IPR of 1.23, 95% CI 1.09-1.38), LOC (IPR of 1.67, 95% CI 1.17-2.37), PTA (IPR of 1.94, 95% CI 1.43-2.62), and RGA (IPR of 2.14, 95% CI 1.38-3.31) accounted for a larger proportion among males. A larger proportion of concussions that were immediately reported was observed in males (IPR of 1.15, 95% CI 1.00-2.31). Proportions of other characteristics (e.g., recurrent injuries) were not different between sexes., Conclusions: A higher proportion of concussions occurred outside of sport and military training for female cadets, who also displayed proportionally longer recovery times than males, despite males demonstrating a higher proportion of LOC, PTA, and RGA. Possible factors may include different mechanisms of injury outside of sport and military training, different biopsychosocial states associated with sex or injury context, and delayed injury reporting when outside of an observed environment, possibly secondary to perceived stigma about reporting injuries., Competing Interests: Declarations Funding This study was made possible, in part, with support from the Grand Alliance Concussion Assessment, Research, and Education Consortium, funded by the National Collegiate Athletic Association and the Department of Defense. The US Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702-5014, USA is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Psychological Health and Traumatic Brain Injury Program under Award no. W81XWH-14-2-0151. Opinions, interpretations, conclusions, and recommendations are those of the authors and are not necessarily endorsed by the Department of Defense (Defense Health Program funds). Conflicts of Interest J.R.C. receives research support from the National Football League. M.P. is the Chief Medical Officer for Major League Soccer, Senior Advisor National Football League Head, Neck and Spine Committee, Football Association Research Task Force, Concussion in Sport Group Expert Group, National Operating Committee on Standards for Athletic Equipment Scientific Advisory Committee. S.P.B. has current or past research funding from the National Institutes of Health, Centers for Disease Control and Prevention, Department of Defense—USA Medical Research Acquisition Activity, National Collegiate Athletic Association, National Athletic Trainers’ Association Foundation, National Football League, Under Armour, GE, Simbex, and ElmindA. He has consulted for US Soccer, US Cycling, University of Calgary SHRed Concussions external advisory board, and medicolegal litigation. He is coauthor of “Biomechanics of Injury (3rd edition)” and has a patent on “Brain Metabolism Monitoring Through CCO Measurements Using All-Fiber-Integrated Super-Continuum Source” (US 11,529,091 B2). T.W.M. receives grant support for concussion research studies from the NCAA, the US Department of Defense, and the NIH. He also receives royalties for a TBI textbook from American Psychiatric Association Publishing, Inc. M.M. receives research funding to the Medical College of Wisconsin from the National Institutes of Health, Department of Veterans Affairs, Centers for Disease Control and Prevention, Department of Defense, National Collegiate Athletic Association, National Football League, and Abbott Laboratories. He receives book royalties from Oxford University Press. He serves as clinical consultant to Milwaukee Bucks, Milwaukee Brewers, and Green Bay Packers, and is Co-Director of the NFL Neuropsychology Consultants without compensation. He serves as a consultant for Neurotrauma Sciences, Inc. The other authors have no potential conflicts of interest with the content of this article. J.B.C. is an Editorial Board member of Sports Medicine. J.B.C. was not involved in the selection of peer reviewers for the manuscript or any of the subsequent editorial decisions. Availability of Data and Materials Deidentified CARE data can be accessed via the Federal Interagency Traumatic Brain Injury Research database https://fitbir.nih.gov. Ethics Approval This study was approved by the institutional review board at each study site, in conjunction with approval from the US Army Human Research Protection Office (see also Supplementary Table 1 for ethics approval numbers for individual institutions). This study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments. Consent to Participate All participants gave written informed consent. Consent for Publication N/A. Code Availability N/A. Author Contributions All authors contributed to the drafting and editing of the manuscript. All authors approved the final manuscript., (© 2024. The Author(s).)

Purpose: Research has demonstrated negative environmental impacts from in-person conferences. Nonetheless, there are benefits to in-person meetings. The 2023 American Pediatric Surgical Association (APSA) meeting was mostly attended in-person. To understand the environmental impact, this study quantifies the travel emissions generated from that meeting., Methods: The 2023 APSA meeting was held in Orlando, FL. Using a de-identified list of attendees, the distance between the attendee's home city and Orlando was determined. If ≤ 200 miles, it was assumed the attendee drove. If > 200 miles, the distance between the closest airport and Orlando International Airport was determined. Travel emissions factors represent emissions per person-mile traveled. The Environmental Protection Agency (EPA) Greenhouse Gas Inventory emissions factors for carbon dioxide (CO 2 ), methane (CH 4 ), and nitrous oxide (N 2 O) were multiplied by travel distances to determine the emissions generated from each attendee. These were aggregated to determine the total meeting travel emissions. The EPA Greenhouse Gas Equivalencies Calculator was used to convert the emissions to a relatable outcome., Results: There were 757 in-person and 135 virtual attendees. Fifty attendees drove and 707 attendees flew. This generated 267,279 kg CO 2 , 1222 gm CH 4 , and 8486 gm N 2 O; equivalent to the emissions generated from the average annual use of 60 gasoline-powered passenger vehicles in the United States., Conclusion: Based on attendance to the 2023 APSA meeting, there is a preference for meeting in-person, though the associated environmental cost should be recognized. Based on these results, APSA should consider strategies to mitigate the environmental impact of its annual meeting., Levels of Evidence: N/A., Competing Interests: Conflicts of interest The authors have no conflicts of interest relevant to this article., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Increasing overlap exists between surgeries performed by podiatrists and orthopaedic surgeons. Large-scale cost comparisons between the two are lacking despite the current climate of cost containment in health care. Using national Medicare data, we aimed to compare per-case Medicare payments between podiatrists and orthopaedic surgeons for ankle fracture fixation., Methods: This retrospective cohort study included patients in an outpatient setting undergoing either unimalleolar, bimalleolar, or trimalleolar ankle fracture repair from the national Medicare Limited Data Set (2013-2019). Type of surgeon (podiatrist or orthopaedic surgeon) was determined using publicly available information. The primary outcome was total Medicare payments specific to the procedure, as a surrogate for cost. A subset analysis was also done to directly compare costs of orthopaedic surgeons to podiatric surgeons while excluding other fees (eg, hospital facility fees and surgery-related imaging payments). Additionally, patient demographics and hospital characteristics were compared to determine if any factors associated with costs may influence group differences. Univariable tests assessed significance of group differences., Results: Overall, 16 927 unimalleolar, 17 244 bimalleolar, and 11 717 trimalleolar fracture repairs were included; 86.7% and 13.3%, 92.4% and 7.6%, and 92.2% and 7.8% were performed by an orthopaedic surgeon or podiatrist, respectively. Median age (70-71 years) and median Charlson-Deyo Comorbidity Index (0) did not significantly differ between patients treated by either surgeon type. Median procedure-specific Medicare payments for all 3 categories of ankle fracture repairs (uni-, bi-, trimalleolar) were significantly lower for orthopaedic surgeons compared to podiatrists: $4156 vs $4300, $4205 vs $4379, and $4396 vs $4525, respectively (all P  < .001)., Conclusion: Our investigation using a national Medicare data set (2013-2019) found that the 3 types of ankle fractures (unimalleolar, bimalleolar, and trimalleolar) performed by orthopaedic surgeons in an outpatient setting were less expensive and that cost differences do not appear to be driven by patient characteristics. These results and further research into the causes of the cost differences may help improve the cost-effectiveness of ankle fracture surgery., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Disclosure forms for all authors are available online.

Background: The discriminatory and racist policy of historical redlining in the United States during the 1930s played a role in perpetuating contemporary environmental health disparities., Objective: Our objectives were to determine associations between home and school pollutant exposure (fine particulate matter [PM 2.5 ], NO 2 ) and respiratory outcomes (Composite Asthma Severity Index, lung function) among school-aged children with asthma and examine whether associations differed between children who resided and/or attended school in historically redlined compared to non-redlined neighborhoods., Methods: Children ages 6 to 17 with moderate-to-severe asthma (N = 240) from 9 US cities were included. Combined home and school exposure to PM 2.5 and NO 2 was calculated based on geospatially assessed monthly averaged outdoor pollutant concentrations. Repeated measures of Composite Asthma Severity Index and lung function were collected., Results: Overall, 37.5% of children resided and/or attended schools in historically redlined neighborhoods. Children in historically redlined neighborhoods had greater exposure to NO 2 (median: 15.4 vs 12.1 parts per billion) and closer distance to a highway (median: 0.86 vs 1.23 km), compared to those in non-redlined neighborhoods (P < .01). Overall, PM 2.5 was not associated with asthma severity or lung function. However, among children in redlined neighborhoods, higher PM 2.5 was associated with worse asthma severity (P < .005). No association was observed between pollutants and lung function or asthma severity among children in non-redlined neighborhoods (P > .005)., Conclusions: Our findings highlight the significance of historical redlining and current environmental health disparities among school-aged children with asthma, specifically, the environmental injustice of PM 2.5 exposure and its associations with respiratory health., Competing Interests: Disclosure statement Supported by the National Institutes of Health (NIH-K01HL140216), Robert Wood Johnson Foundation, and Amos Medical Faculty Development Award. This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), and Department of Health and Human Services under contract numbers 1UM1AI114271-01, UM2AI117870, 5UM1AI114271, NCATS/NIH UL1TR001079, NCATS/NIH 1UL1TR001430, NCATS/NIH UL1TR001873, NCATS/NIH UL1TR002345, UL1TRG01422, NIH/NCATS Colorado CTSA UL1 TR002535, NCATS/NIH UL1TR001876, and NIH/CTSA 5UL1TR001425-03. Disclosure of potential conflict of interest: The authors declare that they have no relevant conflicts of interest., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. All rights reserved.)

Background: The Veterans Health Administration (VHA) implemented the Clinical Resource Hub (CRH) program to fill staffing gaps in primary care (PC) clinics via telemedicine and maintain veterans' healthcare access., Objective: To evaluate PC wait times before and after CRH implementation., Design: Comparative interrupted time series analysis among a retrospective observational cohort of PC clinics who did and did not use CRH during pre-implementation (October 2018-September 2019) and post-implementation (October 2019-February 2020) periods., Participants: Clinics completing ≥10 CRH visits per month for 2 consecutive months and propensity matched control clinics., Main Measures: Two measures of patient access (i.e., established, and new patient wait times) and one measure of clinic capacity (i.e., third next available appointment) were assessed. Clinics using CRH were 1:1 propensity score matched across clinical and demographic characteristics. Comparative interrupted time series models used linear mixed effects regression with random clinic-level intercepts and triple interaction (i.e., CRH use, pre- vs. post-implementation, and time) for trend and point estimations., Key Results: PC clinics using CRH (N = 79) were matched to clinics not using CRH (N = 79). In the 12-month pre-implementation, third next available time increased in CRH clinics (0.16 days/month; 95% CI = [0.07, 0.25]), and decreased in the 5 months post-implementation (-0.58 days/month; 95% CI = [-0.90, -0.27]). Post-implementation third next available time also decreased in control clinics (-0.48 days/month; 95% CI = [-0.81, -0.17]). Comparative differences remained non-significant. There were no statistical differences in established or new patient wait times by CRH user status, CRH implementation, or over time., Conclusions: In a national VHA telemedicine program developed to provide gap coverage for PC clinics, no wait time differences were observed between clinics using and not using CRH services. This hub-and-spoke telemedicine service is an effective model to provide gap coverage while maintaining access. Further investigation of quality and long-term access remains necessary., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Knowledge of Mexican immigrant sleep health is limited. We investigated the association between acculturation, depression, and having trouble sleeping among a nationally representative sample of Mexican immigrant adults. We used a logistic regression model on cross-sectional data from the 2005-2018 National Health and Nutrition Examination Survey on 2,670 non-U.S.-born Mexican adults aged ≥18 years old. Living in the U.S. for ≥10 years (Adjusted Odds Ratio (AOR) = 2.18; 95% Confidence Interval (CI) = 1.39-3.41), speaking majority English (AOR = 1.62; 95% CI = 1.00-2.64), and mild (AOR = 2.70; 95% CI = 1.82-4.02), moderate (AOR = 3.96; 95% CI = 2.53-6.19), and moderately severe/severe (AOR = 5.75; 95% CI = 3.08-10.75) depression levels were associated with having trouble sleeping. Non-U.S. citizenship status was associated with lower odds of having trouble sleeping (AOR = 0.62; 95% CI = 0.43-0.88). Greater acculturation and depression are associated with higher odds of having trouble sleeping. We provide new knowledge on how citizenship status may be linked to the sleep health of Mexican immigrant communities., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)