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Background: In prior studies, the use of standard breast cancer treatments has varied by race, but previous analyses were not nationally representative. Therefore, in a comprehensive, national cohort of Medicare patients, racial disparities in the use of radiotherapy (RT) after breast-conserving surgery (BCS) for invasive breast cancer were quantified.Methods: A national Medicare database was used to identify all beneficiaries (age >65 years) treated with BCS for incident invasive breast cancer in 2003. Claims codes identified RT use, and Medicare demographic data indicated race. Logistic regression modeled RT use in white, black, and other-race patients, adjusted for demographic, clinical, and socioeconomic covariates.Results: Of 34,080 women, 91% were white, 6% were black, and 3% were another race. The mean age of the patients was 76 +/- 7 years. Approximately 74% of whites, 65% of blacks, and 66% of other-race patients received RT (P < .001). After covariate adjustment, whites were found to be significantly more likely to receive RT than blacks (odds ratio, 1.48; 95% confidence interval, 1.34-1.63 [P < .001]). Disparities between white and black patients varied by geographic region, with blacks in areas of the northeastern and southern United States demonstrating the lowest rates of RT use (57% in these regions). In patients age <70 years, racial disparities persisted. Specifically, 83% of whites, 73% of blacks, and 78% of other races in this younger group received RT (P < .001).Conclusions: In this comprehensive national sample of older breast cancer patients, substantial racial disparities were identified in RT use after BCS across much of the United States. Efforts to improve breast cancer care require overcoming these disparities, which exist on a national scale. [ABSTRACT FROM AUTHOR]

BACKGROUND: Classification of menopausal status is important for epidemiological and clinical studies as well as for clinicians treating midlife women. Most epidemiological studies, including the Study of Women's Health Across the Nation (SWAN), classify women based on self-reported bleeding history. METHODS: The Women's Ischemia Syndrome Evaluation (WISE) study developed an algorithm using menstrual and reproductive history and serum hormone levels to reproduce the menopausal status classifications assigned by the WISE hormone committee. We applied that algorithm to women participating in SWAN and examined characteristics of women with concordant and discordant SWAN and WISE classifications. RESULTS: Of the 3215 SWAN women with complete information at baseline (1995-1997), 2466 (76.7%) received concordant classifications (kappa = 0.52); at the fifth annual follow-up visit, of the 1623 women with complete information, 1154 (72.7%) received concordant classifications (kappa = 0.57). At each time point, we identified subgroups of women with discordant SWAN and WISE classifications. These subgroups, ordered by chronological age, showed increasing trends for menopausal symptoms and follicle-stimulating hormone (FSH) and a decreasing trend for estrogen (p < 0.001). CONCLUSIONS: The WISE algorithm is a useful tool for studies that have access to blood samples for hormone data unrelated to menstrual cycle phase, with or without an intact uterus, and no resources for adjudication. Future studies may want to combine aspects of the SWAN and WISE algorithms by adding hormonal measures to the series of bleeding questions in order to determine more precisely where women are in the perimenopausal continuum. [ABSTRACT FROM AUTHOR]

The purpose of the study was to assess a large representative sample of cancer patients on distress levels, common psychosocial problems, and awareness and use of psychosocial support services. A total of 3095 patients were assessed over a 4-week period with the Brief Symptom Inventory-18 (BSI-18), a common problems checklist, and on awareness and use of psychosocial resources. Full data was available on 2776 patients. On average, patients were 60 years old, Caucasian (78.3%), and middle class. Approximately, half were attending for follow-up care. Types of cancer varied, with the largest groups being breast (23.5%), prostate (16.9%), colorectal (7.5%), and lung (5.8%) cancer patients. Overall, 37.8% of all patients met criteria for general distress in the clinical range. A higher proportion of men met case criteria for somatisation, and more women for depression. There were no gender differences in anxiety or overall distress severity. Minority patients were more likely to be distressed, as were those with lower income, cancers other than prostate, and those currently on active treatment. Lung, pancreatic, head and neck, Hodgkin's disease, and brain cancer patients were the most distressed. Almost half of all patients who met distress criteria had not sought professional psychosocial support nor did they intend to in the future. In conclusion, distress is very common in cancer patients across diagnoses and across the disease trajectory. Many patients who report high levels of distress are not taking advantage of available supportive resources. Barriers to such use, and factors predicting distress and use of psychosocial care, require further exploration.British Journal of Cancer (2004) 90, 2297-2304. doi:10.1038/sj.bjc.6601887 www.bjcancer.com Published online 25 May 2004 [ABSTRACT FROM AUTHOR]

Patients with congestive heart failure (CHF) need considerable education to enable them to provide effective self-care for their chronic illness. No information has been published about the learning needs of this population. The purpose of this study was to examine hospitalized CHF patients and their nurses' perceptions regarding the importance and realism of typical patient education content. An instrument to assess learning needs was developed and piloted for use in this study. Thirty hospitalized patients and 26 nurses were surveyed. Both nurses and patients rated all information as important to learn and realistic to learn during the patients' hospitalization. Generally, patients rated information as more important than nurses rated the same information areas. Suggested nursing interventions and future research endeavours are addressed. [ABSTRACT FROM AUTHOR]

Background: Intrapartum antibiotics can prevent early-onset neonatal group B streptococcal (GBS) disease but have not been widely used. Obstacles include difficulty in implementing screening for GBS colonization and uncertainty about cost-effectiveness. The GBS vaccines for disease prevention are now being developed.Methods: We developed a decision analysis model and used standard cost-effectiveness and cost-benefit analysis methods. We compared the outcomes and costs of the recent practice of no intervention with those expected for three prevention strategies: (1) intrapartum antibiotics administered to colonized women with labor complications, (2) an alternative strategy that does not require screening but uses epidemiologic criteria and labor complications to target intrapartum antibiotics, and (3) maternal vaccination. We used data from multistate population-based surveillance to estimate the potential impact of each strategy on disease and costs in the United States.Results: Intrapartum antibiotic prophylaxis of high-risk women identified by screening could prevent approximately 3300 cases (47% of neonatal disease) annually in the United States and could save approximately $16 million in direct medical costs. Chemoprophylaxis of high-risk women identified using epidemiologic criteria could potentially be equally effective (3200 cases prevented) and would avoid the logistical difficulties of screening; the net savings would be approximately $66 million. Vaccinating 80% of pregnant women with a vaccine that prevents 80% of cases among infants born at or after 34 weeks of gestation would prevent approximately 4100 neonatal cases annually with a net savings of $131 million.Conclusions: Universal prenatal screening for GBS and chemoprophylaxis of colonized women with labor complications is likely to be cost-beneficial in the United States. Development of alternative strategies should be further explored for populations in which GBS screening is impractical. Continued development of a GBS vaccine is an important public health priority. [ABSTRACT FROM AUTHOR]

Importance: Cardiovascular disease (CVD) and cancer are the leading causes of mortality in the US. Large-scale population-based and mechanistic studies support a direct effect of CVD on accelerated tumor growth and spread, specifically in breast cancer., Objective: To assess whether individuals presenting with advanced breast cancers are more likely to have prevalent CVD compared with those with early-stage breast cancers at the time of diagnosis., Design, Setting, and Participants: This population-based case-control study used data from the Surveillance, Epidemiology, and End Results-Medicare linked databases from 2009 to 2020. The analysis was completed from May 2023 to August 2024. Participants were female patients aged at least 66 years diagnosed with invasive breast cancer. Cases were matched with controls by breast cancer stage at diagnosis and propensity scores using factors known to be associated with delayed cancer diagnosis., Exposure: Prevalent CVD prior to breast cancer diagnosis., Main Outcomes and Measures: The outcome of interest was the odds of locally advanced (T3-4 or N+) or metastatic (M+) breast cancer status at diagnosis., Results: The full analytic cohort included 19 292 matched individuals, with median (IQR) age 73 (70-79) years, of whom 1676 (8.7%) were Black and 16 681 (86.5%) were White; 9478 individuals (49.1%) had prevalent CVD. Propensity score-matched, multivariable-adjusted models found that individuals with locally advanced or metastatic breast cancer at diagnosis had statistically significantly increased odds of prevalent CVD (odds ratio [OR], 1.10; 95% CI, 1.03-1.17; P = .007). This association was observed among hormone receptor-positive (OR, 1.11; 95% CI, 1.03-1.19; P = .006) but not hormone receptor-negative (OR, 1.02; 95% CI, 0.86-1.21; P = .83) breast cancer. ORs were directionally consistent when separately examining locally advanced (OR, 1.09; 95% CI, 1.02-1.17; P = .02) and metastatic (OR, 1.20; 95% CI, 0.94-1.54; P = .15) disease, among all receptor subtypes., Conclusions and Relevance: This case-control study found that individuals with more advanced breast cancer at diagnosis were more likely to have prevalent CVD. This finding may be specific to hormone receptor-positive and ERBB2-negative (formerly HER2) disease. Future studies are needed to confirm these findings and investigate interventions to improve patient outcomes, including personalized cancer screening.

Objectives: To evaluate how different data sources affect the performance of machine learning algorithms that predict dental general anesthesia use among children with behavioral health conditions., Study Design: Observational study using claims data., Methods: Using Medicaid claims from Partners For Kids (2013-2019), electronic medical record data, and the Ohio Child Opportunity Index, we conducted a retrospective cohort study of 12,410 children with behavioral health diagnoses. Four lasso-regularized logistic regression models were developed to predict dental general anesthesia use, each incorporating different data sources. Lift scores, or the ratio of positive predictive value to base case prevalence, were used to compare models, and a lift score of 2.5 was considered minimally acceptable for risk prediction., Results: Dental general anesthesia use ranged from 3.2% to 3.9% across models, which made it difficult for the machine learning models to achieve high positive predictive value. Model performance was best when either the electronic medical record (lift = 2.59) or Ohio Child Opportunity Index (lift = 2.56), but not both (lift = 2.34) or neither (lift = 1.87), was used., Conclusions: Incorporating additional data sources improved machine learning model performance, and 2 models achieved satisfactory performance. The model using electronic medical record data could be applied in hospital-based settings, and the model using the Ohio Child Opportunity Index could be more valuable in community-based settings., Knowledge Transfer Statement: Machine learning was applied to satisfactorily predict which children with behavioral health diagnoses would require dental treatment under general anesthesia. Incorporating electronic medical record data or area-level social determinants of health data, but not both, improved the performance of the machine learning predictions. The 2 highest performing models could be applied by hospitals using medical record data or by organizations using area-level social determinants of health data to risk stratify the pediatric behavioral health population., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Physician involvement in political advocacy has become increasingly important in recent years. This study aims to explore the types of involvement and barriers to involvement in political advocacy among American Shoulder and Elbow Surgeons (ASES) members, identify issues considered most important by ASES members, and assess demographic factors that might correlate with involvement in political advocacy efforts among ASES members., Methods: This survey was conducted by the ASES Political Advocacy Committee over a 2-week period in June 2021. The survey collected demographic information including sex, ethnicity, years in practice, practice type, political affiliation, and level of current involvement in political advocacy. Additional questions consisted of thoughts regarding current health care policy issues and the role of the American Academy of Orthopaedic Surgeons/ASES regarding such policy issues., Results: We received 297 responses for a total response rate of 27%. Of those who responded, 24.6% identified as Democrat, 33% identified as Republican, and 42.4% identified as Independent. There was no difference in political affiliation between membership groups. Physician Reimbursement (82%), Medical Liability Reform (50%), and Physician Ownership (50%) were the most important issues identified among respondents. Physician Ownership, Physician Reimbursement and Graduate Medical Education and Student Loan Reform were most important to those in early practice, while Quality and Research was most important to those with greater than 25 years of practice experience., Conclusion: There is strong agreement among surgeons regarding the most important political advocacy issues. The efforts of the American Academy of Orthopaedic Surgeons and ASES should focus on these areas. Additionally, the vast majority of respondents felt that advocacy efforts had a positive impact on patients and surgeons., (Copyright © 2024 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

The goal of the American Association of Bronchology and Interventional Pulmonology Essential Knowledge in Interventional Pulmonology Series is to provide clinicians with concise, up-to-date reviews of important topics in the field of interventional pulmonology. This 3-year alternating rotation of primary topics will start with a focus on selected topics in malignant pleural disease. In this article, we update the reader on malignant pleural effusion in 3 parts: part 1-diagnosis, focusing on imaging and fluid biomarkers; part 2-management, with review of multimodal approaches, cost considerations, and evolving targeted therapies; and part 3-pleural mesothelioma. These reviews complement the Essential Knowledge in Interventional Pulmonology Lecture Series presented at the 2023 AABIP Annual Conference, available for viewing on the AABIP website (https://aabip.memberclicks.net/essential-knowledge-in-interventional-pulmonology-series)., Competing Interests: Disclosure: A.A.C.: consultant for Intuitive Inc. The remaining authors have no conflict of interest or other disclosures., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Respiratory syncytial virus (RSV) is a leading cause of acute respiratory illness (ARI) in older adults. Optimizing diagnosis could improve understanding of RSV burden., Methods: We enrolled adults ≥50 years of age hospitalized with ARI and adults of any age hospitalized with congestive heart failure or chronic obstructive pulmonary disease exacerbations at 2 hospitals during 2 respiratory seasons (2018-2020). We collected nasopharyngeal (NP) and oropharyngeal (OP) swabs (n = 1558), acute and convalescent sera (n = 568), and expectorated sputum (n = 153) from participants, and recorded standard-of-care (SOC) NP results (n = 805). We measured RSV antibodies by 2 immunoassays and performed BioFire testing on respiratory specimens., Results: Of 1558 eligible participants, 92 (5.9%) tested positive for RSV by any diagnostic method. Combined NP/OP polymerase chain reaction (PCR) testing yielded 58 positives, while separate NP and OP testing identified 11 additional positives (18.9% increase). Compared to study NP/OP PCR alone, the addition of paired serology increased RSV detection by 42.9% (28 vs 40) among those with both specimen types, while the addition of SOC swab PCR increased RSV detection by 25.9% (47 vs 59)., Conclusions: The addition of paired serology testing, SOC swab results, and separate testing of NP and OP swabs improved RSV diagnostic yield in hospitalized adults., Competing Interests: Potential conflicts of interest. E. J. A. has consulted for Pfizer, Sanofi Pasteur, GSK, Janssen, Moderna, and Medscape; served on a safety monitoring board for Kentucky BioProcessing, Inc and Sanofi Pasteur; served on a data adjudication board for WCG and ACI Clinical; is currently employed by Moderna; and his institution had received funds to conduct clinical research unrelated to this study from MedImmune, Regeneron, PaxVax, Pfizer, GSK, Merck, Sanofi-Pasteur, Janssen, and Micron, and from the National Institutes of Health to conduct clinical trials of COVID-19 vaccines. C. A. R. has received institutional support from ModernaTX, Inc, Pfizer, Inc, BioFire, Inc, GSK, plc, MedImmune, Micron Technology, Inc, Janssen Pharmaceuticals, Merck & Co, Inc, Novavax, PaxVax, Regeneron, Sanofi Pasteur, the Centers for Disease Control and Prevention, and the National Institutes of Health; and is coinventor of patented RSV vaccine technology licensed to Meissa Vaccines, Inc. L. J. A. has done paid consultancies on RSV vaccines for Bavarian Nordic, ClearPath Vaccines Company, Janssen, Pfizer, and ADVI; is a coinventor on several CDC patents on the RSV G protein and its CX3C chemokine motif relative to immune therapy and vaccine development; is coinventor on a patent filing for use of RSV platform VLPs with the F and G proteins for vaccines; and his laboratory is currently receiving funding through Emory University from Pfizer for laboratory studies for RSV surveillance studies in adults, Sciogen for animal studies of RSV vaccines, and Advaccine Pharmaceuticals, Ltd for RSV neutralizing antibody studies. N. R. serves as safety consultant for ICON, CyanVac, and EMMES; serves or has served on the advisory boards for Sanofi, Seqirus, Pfizer, and Moderna; and her institution receives funds to conduct research from Sanofi, Lilly, Merck, Quidel, Immorna, Vaccine Company, and Pfizer. E. B., R. H., Q. L., B. D. G., L. J., D. S., W. K., and S. U. are employees of Pfizer, Inc with stock/stock options or were employees during the conduct of this study. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Introduction: Use of oral anticoagulants (OACs) for stroke reduction in atrial fibrillation (AF) varies by race and geography within the United States. We seek to better understand the relationship between OAC underutilization, race, and US geography., Methods: Patients with AF were selected from the US Centers for Medicare & Medicaid Services claims database from January 1, 2013, to December 31, 2016. The final population consisted of patients with 12 months of health plan enrollment before and after their index AF diagnosis, with a baseline CHAD2S2-VASc ≥2 and of either Black or White race (other races are underrepresented in the data). Among those with AF that met the inclusion criteria, patients who were prescribed warfarin or DOACs within 12 months after the index date were extracted. Each patient was assigned to a US county based on their 5-digit zip code and OAC use was stratified by race. Statistically significant differences were determined by student's t-test and chi-square., Results: Of the 2,390,830 final patients, 94.1% were White and 5.9% were Black patients. Mean (SD) age and HASBLED scores were 78 (9) and 3.9 (1.2) respectively, for Black patients and 80 (9) and 3.3 (1.2), respectively, for White patients (p<0.0001). The mean (SD) CHAD2S2-VASc scores were 4.5 (1.9) for White patients, and 5.3 (1.9) for Black patients with p<0.0001, respectively. Black patients (vs White patients) had a higher non-treatment (no DOAC or warfarin) rate (56.1% vs 47.4%, p<0.0001) across the US which was particularly notable in the southeast. In addition, treatment rates were highly variable within each US state. Counties with dense population more frequently demonstrated significant differences by race than counties with sparse population., Conclusion: Our study showed differences in the use of OACs across US counties and among various racial groups. These disparities highlighted the areas of unmet need for both Black and White patients., Competing Interests: The authors have read the journal’s policy and have the following competing interests: BDA is an employee of Inova Health System, and was a paid consultant to Bristol-Myers Squibb/Pfizer in connection with this study. LRJ is an employee of Duke University, and was a paid consultant to Bristol-Myers Squibb/Pfizer in connection with this study. VN was employed by STATinMED, a paid consultant company to Bristol Myers Squibb/Pfizer, outside of the submitted work. AK, NA, MH, and JJ are employees of Bristol Myers Squibb, a study sponsor. DMH is an employee of Pfizer, a study sponsor. There are no patents, products in development or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Jackson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Importance: Medicaid programs have expanded coverage of substance use disorder treatment and undertaken many other initiatives to reduce drug overdoses among beneficiaries. However, to date, no information has been published that tracks overdose deaths among the Medicaid population., Objective: To determine the rate of drug overdose among Medicaid beneficiaries., Design, Setting, and Participants: In this cross-sectional study, US Centers for Medicare & Medicaid Services data from 2016 to 2020 that linked enrollment and demographic data from all Medicaid beneficiaries in the US with the US Centers for Disease Control and Prevention National Death Index were used to determine the rate of drug overdose death among Medicaid beneficiaries. The Medicaid population rates were compared with those of the total US population, overall and by age and sex., Exposure: Participation in the Medicaid program., Main Outcome: Death of a drug overdose., Results: In 2020, the drug overdose death rate among Medicaid beneficiaries was 54.6 per 100 000, a rate that was twice as high as the drug overdose rate among all US residents (27.9 per 100 000). In 2020, Medicaid beneficiaries comprised 25.0% of the US population but 48% of all overdose deaths (44 277 of 91 783). For each age and sex group older than 15 years, overdose deaths were higher for the Medicaid population than for the US population, with the greatest difference occurring among adults ages 45 to 64 years. From 2016 to 2020, Medicaid overdose deaths increased by 54%., Conclusions and Relevance: The results of this study suggest that more research is needed to understand why Medicaid beneficiaries have higher rates of drug overdoses than all US residents. Additionally, research is needed to understand how best to prevent overdoses among Medicaid beneficiaries. The federal government should support these efforts by routinely linking Medicaid claims and enrollment data to death records.

Background: Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract disease (LRTD) among adults and can lead to serious morbidity and mortality; however, evidence on the magnitude of the public health and economic burden of adult RSV-LRTD is limited. This study was undertaken to project annual clinical outcomes and economic costs of medically attended RSV-LRTD among US adults, and to identify subgroups responsible for a disproportionate share of disease burden., Methods: Clinical outcomes of RSV-LRTD were projected for subgroups of US adults defined by age and comorbidity profile (with vs. without chronic/immunocompromising medical conditions) based on corresponding population sizes, episode (disease) rates, and case-fatality rates. Economic costs comprised medical (i.e., direct) costs and non-medical (i.e., indirect) costs of RSV-LRTD, and were generated based on numbers of episodes and unit costs in relation to setting of care, age, and comorbidity profile., Results: Among 265 million US adults aged ≥18 years in 2023, 6.5 million medically attended episodes of RSV-LRTD were projected to occur including 349,260 requiring hospitalization, 357,892 requiring an emergency department visit (not leading to hospitalization), and 5.8 million requiring other ambulatory care. Direct costs ($15.2 billion) and indirect costs ($9.7 billion) were projected to total $25.0 billion. Persons aged 60-99 years accounted for 31 % of the adult population and over 50 % of the economic burden of RSV-LRTD, while adults aged <60 years with chronic/immunocompromising medical conditions accounted for 10 % of the population and 27 % of the economic burden., Conclusions: Annual burden of RSV-LRTD among US adults-especially older adults and those of all ages with underlying medical conditions-is substantial. Preventive measures, such as recently approved RSV vaccines, have the potential to yield important improvements in public and patient health, and to reduce the economic burden of RSV-LRTD from the US healthcare system and societal perspectives., 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 Ltd.. All rights reserved.)

Despite increasing prevalence of hypertension in youth and high adult cardiovascular mortality rates, the long-term consequences of youth-onset hypertension remain unknown. This is due to limitations of prior research, such as small sample sizes, reliance on manual record review, and limited analytic methods, that did not address major biases. The Study of the Epidemiology of Pediatric Hypertension (SUPERHERO) is a multisite, retrospective registry of youth evaluated by subspecialists for hypertension disorders. Sites obtain harmonized electronic health record data using standardized biomedical informatics scripts validated with randomized manual record review. Inclusion criteria are index visit for International Classification of Diseases, 10th Revision (ICD-10) code-defined hypertension disorder on or after January 1, 2015, and age < 19 years. We exclude patients with ICD-10 code-defined pregnancy, kidney failure on dialysis, or kidney transplantation. Data include demographics, anthropomorphics, US Census Bureau tract, histories, blood pressure, ICD-10 codes, medications, laboratory and imaging results, and ambulatory blood pressure. SUPERHERO leverages expertise in epidemiology, statistics, clinical care, and biomedical informatics to create the largest and most diverse registry of youth with newly diagnosed hypertension disorders. SUPERHERO's goals are to reduce CVD burden across the life course and establish gold-standard biomedical informatics methods for youth with hypertension disorders., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.)

Generative artificial intelligence (AI) raises ethical questions concerning moral and legal responsibility-specifically, the attributions of credit and blame for AI-generated content. For example, if a human invests minimal skill or effort to produce a beneficial output with an AI tool, can the human still take credit? How does the answer change if the AI has been personalized (i.e., fine-tuned) on previous outputs produced without AI assistance by the same human? We conducted a preregistered experiment with representative sampling (N = 1802) repeated in four countries (United States, United Kingdom, China, and Singapore). We investigated laypeople's attributions of credit and blame to human users for producing beneficial or harmful outputs with a standard large language model (LLM), a personalized LLM, or no AI assistance (control condition). Participants generally attributed more credit to human users of personalized versus standard LLMs for beneficial outputs, whereas LLM type did not significantly affect blame attributions for harmful outputs, with a partial exception among Chinese participants. In addition, UK participants attributed more blame for using any type of LLM versus no LLM. Practical, ethical, and policy implications of these findings are discussed., (© 2024 The Author(s). Annals of the New York Academy of Sciences published by Wiley Periodicals LLC on behalf of The New York Academy of Sciences.)

National performance metrics ultimately enhance patient decision-making and promote meaningful improvements in health care delivery, which makes having valid and reliable measures essential. This study examined US News and World Report metrics from 2019 to 2012 and used electronic health record data, combined with detailed chart review across 3 in-system hospitals, to assess the provision of care compared to the attribution of patients assigned to the ear, nose, and throat (ENT) mortality group. Of the initial 47 ENT-attributed deaths, 23 of those were verified, dimensioning the mortality rate from 1.7% to just 0.8%. These results underscore the necessity of rethinking measures and mortality attribution methodologies to be more accurate. Current methods use Medicare Severity Diagnosis Related Group billing coding to map the attribution. We suggest transitioning away from specialty ranking approaches and towards a procedure and condition "rating" approach to ensure that these ranking types capture data about the provision of care within a given encounter., (© 2024 American Academy of Otolaryngology–Head and Neck Surgery Foundation.)

Rationale and Objectives: The Association of Program Directors in Radiology (APDR) administers an annual survey to assess issues and experiences related to residency program management and education. Our purpose is to provide the response data from the 2023 survey and discuss its insights on the impact of COVID-19 on resident recruitment (Part I) and education (Part II), which can be used to facilitate planning and resource allocation for the evolving needs of programs and their leadership. In Part I, we consider the effects of ERAS preference signaling, the virtual interview format, and the potential of a universal interview release date., Materials and Methods: An observational, cross-sectional study of the APDR membership was performed using a web-based survey consisting of 45 questions, 23 of which pertain to virtual recruitment and are discussed in Part I of a two-part survey analysis. All active APDR members (n = 393) were invited to participate in the survey., Results: The response rate was 32% (124 of 393). 83% reported that signaling increased the likelihood of an interview offer. 96% reported only offering virtual interviews; however, 59% intended to offer virtual-only interviews in the future. 53% would adhere to a universal interview release date but an additional 44% would do so depending on the agreed date, Results were tallied using Qualtrics software and qualitative responses were tabulated or summarized as comments., Conclusions: Virtual recruitment is expected to continue for many programs and most respondents would accept a universal interview release date. Preference signaling and geographic signaling are considered positive additions to the application process., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brent D. Griffith reports a relationship with Association of Program Directors in Radiology that includes: board membership. Carolynn M. DeBenedectis reports a relationship with Association of Program Directors in Radiology that includes: board membership. Priscilla J. Slanetz reports a relationship with Association of Academic Radiology that includes: board membership. Priscilla J. Slanetz is a board member of the AAR Research and Education Fund and ACR Board of Chancellors, and Member of the Editorial Boards of Radiology and Academic Radiology. If there are other authors, they 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 Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

Rationale and Objectives: The Association of Program Directors in Radiology (APDR) administers an annual survey to assess issues and experiences related to residency program management and education. Response data from the 2023 survey provides insights on the impact of COVID-19 on resident recruitment (Part I) and education (Part II), which can be used to facilitate planning and resource allocation for the evolving needs of programs and their leadership., Materials and Methods: An observational, cross-sectional study of the APDR membership was performed using a web-based survey consisting of 45 questions, 12 of which pertain to resident education in the post-pandemic era and are discussed in Part II of a two-part survey analysis. All active APDR members (n = 393) were invited to participate in the survey., Results: The response rate was 32% (124 of 393). Results were tallied using Qualtrics software and qualitative responses were tabulated or summarized as comments., Conclusions: The primary challenges to resident education are faculty burnout, rising case volumes, and remote instruction. However, most program leaders report that in-person readouts are much more common than remote readouts. The ability to offer both in-person and remote AIRP sessions is viewed positively. Most program leaders require Authorized User certification, although many do not think all residents need it. Assessment of procedural competence varies by the type of procedure and is similar to graduates' self-assessment of competence., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brent D. Griffith reports a relationship with Association of Program Directors in Radiology that includes: board membership. Carolynn M. DeBenedectis reports a relationship with Association of Program Directors in Radiology that includes: board membership. Priscilla J. Slanetz reports a relationship with Association of Academic Radiology that includes: board membership. Priscilla J. Slanetz is a board member of the AAR Research and Education Fund and ACR Board of Chancellors, and Member of the Editorial Boards of Radiology and Academic Radiology. If there are other authors, they 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 Association of University Radiologists. Published by Elsevier Inc. All rights reserved.)

Background: The epidemiology of testicular trauma in sports on a national scale has not been well studied. Timely management and treatment after testicular trauma is critical to avoid serious, long-term ramifications of mismanagement., Objective: The aim was to analyze trends in sports-related testicular trauma based on specific sports and patient demographic characteristics over time., Methods: The National Electronic Injury Surveillance System was queried for emergency department cases between 2012 and 2021 with injuries in the pubic region related to 10 commonly played sports. Variables examined included patient age, race, disposition, and sport using incidence rate, incidence rate ratios, and χ 2 analysis., Results: There were an estimated 28,844 emergency department cases of sports-related testicular trauma between 2012 and 2021. Young patients, aged between 10 and 14 years and 15 and 19 years, accounted for most cases, and results of χ 2 analysis showed a significant difference in incidence based on age group (p < 0.01). Most injuries occurred while athletes played basketball, football, and soccer (73.6%)., Conclusions: Sports-related testicular trauma injury rates remained steady between 2012 and 2021, which suggests greater efforts are necessary to reduce the incidence of sports-related testicular trauma. Education efforts should focus on 10- to 19-year-olds because they have the highest incidence. Given the high incidence in sports like basketball and soccer compared with football and lacrosse, testicular trauma seems to be a risk for athletes competing both recreationally and competitively., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: With the recent Food & Drug Administration (FDA) approval of cellular therapy that requires product manipulation prior to administration in combination with a short stability window, the need was identified for local dose preparation within the pharmacy rather than the off-site stem cell processing laboratory. This approval gave rise to assessment of regulatory standards surrounding cellular therapy, evaluation and revision of current standard operating procedures and policies with formal process validation, assessment of occupational exposure mitigation and safety considerations, and development of staff training and education., Objective: To describe and provide insight into the stepwise process of FACT validation and onboarding of commercially available cellular therapy products that require sterile compounding manipulation within a pharmacy prior to administration., Discussion: A multidisciplinary effort is required to attain FACT certification and implement pharmacist compounding of cellular therapy products. 1 Local preparation within a pharmacy facilitates a sound operational workflow and provides a pathway to perform aseptic manipulations of cellular therapy products safely and efficiently., Conclusion: Safe and successful administration of cellular therapies handled and compounded by pharmacy department staff along with program validation requires a preemptive review utilizing a multidisciplinary approach for process development. This manuscript will provide a foundation based on consistency and transparency in effective cellular therapy sterile compounding and aseptic manipulation, proper handling and disposal procedures, increased communication through creation and optimization of treatment plans and order-sets, standardized medical center staff education, and development of policies and standard operating procedures for the entire health care team., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: To improve the healthfulness of foods offered while accelerating the use of environmental sustainability practices, it is important to engage hospital food service operators in the adoption of such practices. The purpose of this study was to explore barriers, facilitators and best practices for implementing environmental sustainability standards in food service among veterans affairs (VA) hospitals in the United States., Methods: We conducted an online survey with 14 VA hospital food service directors and then 11 qualitative interviews. The survey assessed motivations for initiating sustainability standards and included a self-rating of implementation for each of five standards: increasing plant-forward dishes, procuring and serving sustainable foods that meet organic/fair trade and other certifications, procuring and serving locally produced foods, reducing food waste and reducing energy consumption. Interviews were transcribed verbatim. Qualitative analysis, including coding of themes and subthemes, was conducted by two coders to determine barriers, facilitators and best practices for each of these five standards. Quantitative methods (counts and frequencies) were used to analyse the survey data., Results: Participants had an average of 5 years of experience implementing sustainability standards. The top three motivators cited were reducing food waste, serving healthier foods and increasing efficiency or cost savings. Barriers revolved around patient preferences, contractual difficulties and costs related to reducing waste. Facilitators included taste testing new recipes that include more sustainable food options and easy access to sustainable products from the prime vendor. Best practices included making familiar dishes plant-forward and plate waste studies to prevent overproduction., Conclusions: Although there were many barriers to implementation, food service directors had solutions for overcoming challenges and implementing food service sustainability standards, which can be tested in future sustainability initiatives., (Published 2024. This article is a U.S. Government work and is in the public domain in the USA. Journal of Human Nutrition and Dietetics published by John Wiley & Sons Ltd on behalf of British Dietetic Association.)

Background: The evolution of neuroendovascular technologies has progressed substantially. Over the last two decades, the introduction of new endovascular devices has facilitated treatment for more patients, and as a result, the regulatory environment concerning neuroendovascular devices has evolved rapidly in response., Objective: To examine trends in the approval of neuroendovascular devices by the United States Food and Drug Administration (FDA) over the last 20 years., Methods: Open-access US FDA databases were queried between January 2000 and December 2022 for all devices approved by the Neurological Devices Advisory Committee. Neuroendovascular devices were manually classified and grouped by category. Device approval data, including approval times, approval pathway, and presence of predicate devices, were examined., Results: A total of 3186 neurological devices were approved via various US FDA pathways during the study period. 320 (10.0%) corresponded to neuroendovascular devices, of which 301 (94.1%) were approved via the 510(k) pathway. The percentage of 510(k) pathway neuroendovascular devices increased from 6.9% to 14.3% of all neuro devices before and after 2015, respectively. There was an increase in approval times for neuroendovascular devices cleared after 2015., Conclusion: Over the last two decades, the neuroendovascular device armamentarium has rapidly expanded, especially after positive stroke trials in 2015. Regulatory approval times are significantly affected by device category, generation, company size, and company location, and a vast majority are approved by the 510(k) pathway. These results can guide further innovation in the endovascular device space and may act as a roadmap for future regulatory planning., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

The field of microbial ecology, evolution, and biodiversity (EEB) is at the leading edge of understanding how microbes shape our biosphere and influence the well-being of humankind and Earth. To that end, EEB is developing new transdisciplinary tools to analyze these ecologically critical, complex microbial communities. The American Society for Microbiology's Council on Microbial Sciences hosted a virtual retreat in 2023 to discuss the trajectory of EEB both within the Society and microbiology writ large. The retreat emphasized the interconnectedness of microbes and their outsized global influence on environmental and host health. The maximal potential impact of EEB will not be achieved without contributions from disparate fields that unite diverse technologies and data sets. In turn, this level of transdisciplinary efforts requires actively encouraging "broad" research, spanning inclusive global collaborations that incorporate both scientists and the public. Together, the American Society for Microbiology and EEB are poised to lead a paradigm shift that will result in a new era of collaboration, innovation, and societal relevance for microbiology., Competing Interests: The authors declare no conflict of interest.

Associations with soil microorganisms are crucial for plants' overall health and functioning. While much work has been done to understand drivers of rhizosphere microbiome structure and function, the relative importance of geography, climate, soil properties, and plant genetics remains unclear, as results have been mixed and comprehensive studies across many sites and genotypes are limited. Rhizosphere microbiomes are crucial for crop resistance to pathogens, stress tolerance, nutrient availability, and ultimately yield. Here, we quantify the relative roles of plant genotype, environment, and their interaction in shaping soil rhizosphere communities, using 16S and ITS gene sequencing of rhizosphere soils from 10 genotypes of cultivated sunflower ( Helianthus annuus ) at 15 sites across the Great Plains of the United States. While site generally outweighed genotype overall in terms of effects on archaeal, bacterial, and fungal richness, community composition, and taxa relative abundances, there was also a significant interaction such that genotype exerted a significant influence on archaeal, bacterial, and fungal microbiomes in certain sites. Site effects were attributed to a combination of spatial distance and differences in climate and soil properties. Microbial taxa that were previously associated with resistance to the fungal necrotrophic pathogen Sclerotinia were present in most sites but differed significantly in relative abundance across sites. Our results have implications for plant breeding and agronomic microbiome manipulations for agricultural improvement across different geographic regions.IMPORTANCEDespite the importance of plant breeding in agriculture, we still have a limited understanding of how plant genetic variation shapes soil microbiome composition across broad geographic regions. Using 15 sites across the Great Plains of North America, we show that cultivated sunflower rhizosphere archaeal, bacterial, and fungal communities are driven primarily by site soil and climatic differences, but genotype can interact with site to influence the composition, especially in warmer and drier sites with lower overall microbial richness. We also show that all taxa that were previously found to be associated with resistance to the fungal pathogen Sclerotinia sclerotiorum were widespread but significantly affected by site, while a subset was also significantly affected by genotype. Our results contribute to a broader understanding of rhizosphere archaeal, bacterial, and fungal community assembly and provide foundational knowledge for plant breeding efforts and potential future microbiome manipulations in agriculture., Competing Interests: The authors declare no conflict of interest.

Per- and polyfluoroalkyl substances (PFAS), known colloquially as "forever chemicals," have been associated with adverse human health effects and have contaminated drinking water supplies across the United States owing to their long-term and widespread use. People in the United States may unknowingly be drinking water that contains PFAS because of a lack of systematic analysis, particularly in domestic water supplies. We present an extreme gradient-boosting model for predicting the occurrence of PFAS in groundwater at the depths of drinking water supply for the conterminous United States. Our model results indicate that 71 million to 95 million people in the conterminous United States potentially rely on groundwater with detectable concentrations of PFAS for their drinking water supplies before any treatment.

Purpose: To characterize dietary patterns and examine associations with cross-sectional and longitudinal changes in quality of life (QOL) over approximately one year after colorectal cancer (CRC) diagnosis., Methods: The ColoCare Study is an international, multi-center, prospective cohort study of newly diagnosed CRC survivors of any stage. A subset of participants with CRC in the United States completed patient-reported outcome measures at 6- and 12-months post-enrollment, including the Food Frequency Questionnaire (FFQ) and European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Dietary patterns at 6 months (around the time of treatment completion) were identified using Principal Component Analysis (PCA) with varimax rotation. Adherence scores were calculated for participants within each dietary pattern, with higher scores indicating higher adherence. Mixed models were used to examine the effect of each dietary pattern on changes in QOL at 6- and 12-month follow-ups, controlling for cancer stage, biological sex, body mass index (BMI), smoking status, and age., Results: Participants (N = 174) were, on average, 56 ± 14 years old and were mostly female (51.5%), stage III or IV (51.7%), never smokers (60.2%), non-Hispanic (97.1%), and White (83.3%) with a BMI of 27.9 ± 6.1 kg/m 2 . PCA revealed two emerging dietary patterns: "Western diet", characterized by processed meats, refined grains, and sugars, and "Prudent diet" characterized by lean proteins, fruits, and vegetables. Higher adherence to a Western diet was associated with worse social functioning at 6-month follow-up (FE = -12.6, p = 0.010). Loss of appetite from 6 to 12 months was associated with higher adherence to both the Western and Prudent dietary patterns (FE = 1.5, p = 0.044; FE = 1.3, p = 0.046, respectively). Neither dietary pattern was associated with global QOL score at 6- or 12-month follow-up ( p 's > 0.05)., Conclusions: Among CRC survivors in the United States, the Western diet was concurrently associated with worse social functioning. Loss of appetite was reported by CRC survivors following both dietary patterns, suggesting that loss of appetite may be a global experience for CRC survivors during this timeframe. Further research is needed to understand specific social challenges experienced by CRC survivors and develop supportive care interventions to address appetite and nutritional concerns.

Introduction: Excess rates of Gulf War illness (GWI) and irritable bowel syndrome (IBS), two chronic multisymptom illnesses, have long been documented among nearly 700,000 veterans who served in the 1990-1991 Persian Gulf War. We sought to report the prevalence, characteristics, and association of GWI and IBS decades after the war in a clinical cohort of deployed Gulf War veterans (GWVs) who were evaluated at the Department of Veterans Affairs' War Related Illness and Injury Study Center (WRIISC) for unexplained chronic symptoms., Materials and Methods: We analyzed data gathered from clinical intake questionnaires of deployed GWVs who were evaluated at WRIISC clinics between 2008 and 2020. We applied Centers for Disease Control (CDC) criteria to determine the prevalence of severe GWI. IBS was identified using Rome IV diagnostic criteria (current IBS) and veterans' self-reported "history of physician-diagnosed IBS." We examined associations between IBS and GWI using bivariate analyses and multivariable logistic regression., Results: Among the N = 578 GWVs evaluated by the WRIISC, severe GWI (71.8%), history of physician-diagnosed IBS (50.3%) and current IBS (42.2%) were all highly prevalent. Nearly half of GWVs with severe GWI met Rome criteria for IBS (45.8%), and over half reported a history of physician-diagnosed IBS (56.1%). In multivariable models, severe GWI was significantly associated both with current IBS (adjusted odds ratio (aOR): 1.68, 95% CI: 1.11, 2.54) and with veteran-reported history of physician-diagnosed IBS (aOR: 2.15, 95% CI: 1.43, 2.23). IBS with diarrhea (IBS-D) was the most common subtype among GWVs with current IBS (61.1%). However, IBS-mixed affected a significantly greater proportion of veterans with severe GWI, compared to veterans who did not have severe GWI (P = .03)., Conclusions: More than 20 years after the Persian Gulf War, our findings indicate a high degree of comorbidity between severe GWI and IBS among deployed GWVs seeking care for unexplained illnesses. Our results suggest GWVs with GWI should be screened for IBS for which evidence-based treatments are available and could potentially reduce symptom burden. Conversely, symptoms of IBS should trigger additional evaluation for non-gastrointestinal symptoms in deployed Gulf War veterans to identify possible GWI and ensure a comprehensive approach to care., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2024. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Importance: Millions of adults with low incomes lose Medicaid eligibility when transitioning to Medicare at age 65 years. However, it remains unclear how this transition is associated with dental care., Objective: To examine the consequences of transitions from Medicaid to Medicare on coverage and use of dental services., Design, Setting, and Participants: Cross-sectional data from the Health and Retirement Study from 2014 to 2020 and a regression discontinuity design were used to compare changes in outcomes before and after turning age 65 years among a population likely to be Medicaid-eligible before age 65 years. The sample included adults aged 50 to 90 years who had not attended college in 28 states., Exposure: Transitions from Medicaid to Medicare at age 65 years., Main Outcomes and Measures: Health insurance (Medicaid, Medicare, dual coverage, private, and uninsurance), dental coverage (Medicaid, Medicare, private, or none), and having a dental visit and out-of-pocket dental spending during the previous 2 years., Results: Of the 15 837 study participants, 9510 (56.2% weighted) were female, 6984 (28.7% weighted) were Black individuals, Hispanic individuals, and individuals of other race (including American Indian, Alaskan Native, Asian, Native Hawaiian, and Pacific Islander individuals), and 8853 (71.3% weighted) were White; the mean (SD) age was 69.2 (10.3) years. Turning age 65 years was associated with an increase in Medicare coverage in states with Medicaid dental benefits (66.5 percentage points [pp]; 95% CI, 58.3-74.7) and those without dental benefits (67.8 pp; 95% CI, 52.6-83.0). There was a concurrent reduction in private coverage, Medicaid, and uninsured rates. For dental outcomes, in states providing Medicaid dental benefits, turning age 65 years was associated with a 13.1-pp decrease in the likelihood of dental coverage (95% CI, 10.7-15.5), largely due to the loss of Medicaid dental coverage. Among adults reporting being Black, Hispanic, or other race, there was a 3.9-pp decline in dental visits during the previous 2 years (95% CI, -6.1 to -1.7). In states without Medicaid dental benefits, turning age 65 years was associated with no change in the likelihood of dental coverage and a 15.6-pp increase in dental visits (95% CI, 6.3-25.0). Out-of-pocket dental spending decreased in both groups of states (-13.0% [95% CI, -24.2 to -0.1] and -19.2% [95% CI, -33.6 to -1.6], respectively)., Conclusions and Relevance: The results of this cross-sectional study suggest that transitioning from Medicaid to Medicare at age 65 years was associated with a lower level of dental coverage and may increase barriers to accessing dental care for beneficiaries who had Medicaid dental coverage before age 65 years. However, for adults living in states without Medicaid dental benefits, the transition was associated with increased use of dental services and no change in overall dental coverage rates.

Purpose: Precision therapies and immunotherapies have revolutionized cancer care, with novel genomic biomarker-associated therapies being introduced into clinical practice rapidly, resulting in notable gains in patient survival. Despite this, there is significant variability in the utilization of tumor molecular profiling that spans the timing of test ordering, comprehensiveness of gene panels, and clinical decision support through therapy and trial recommendations., Methods: To standardize testing, we designed a pathologist-directed test ordering system at the time of diagnosis using a 523-gene DNA/RNA hybrid comprehensive genomic profiling (CGP) panel and extensive clinical decision support tools. To comprehensively characterize the clinical impact of this protocol, we developed a novel natural language processing (NLP)-based approach to extract clinical features from physician chart notes. We assessed test actionability rates, therapy choice, and outcomes across a set of 3,216 patients with advanced cancer., Results: We observed 49% of patients had at least one actionable genomic biomarker-driven-approved and/or guideline-recommended targeted or immunotherapy (IO) and 53% of patients would have been eligible for a precision therapy clinical trial from three large basket trials. When assessing CGP versus an in silico 50-gene panel, 67% of tumors compared with 33% harbored actionable alterations including clinical trials. Among patients with 6 months or more of follow-up, over 52% received a targeted therapy (TT) or IO, versus 32% who received conventional chemotherapy alone. Furthermore, patients receiving TT had significantly improved overall survival compared with patients receiving chemotherapy alone ( P < .001)., Conclusion: Overall, these data represent a major shift in standard clinical practice toward molecularly guided treatments (targeted and immunotherapies) over conventional systemic chemotherapy. As guidelines continue to evolve and more precision therapeutics gain approval, we expect this gap to continue to widen.

The Affordable Care Act Marketplaces may improve access to dental insurance, but little is known about the availability of such coverage. We used data from state and federal Marketplace sources to describe the availability of adult dental plans, including Stand-alone Dental Plans and those embedded in medical plans. We also examined the characteristics of counties with limited dental insurer participation and those that experienced a net loss of Stand-alone Dental Plan insurers between 2016 and 2023. We found that in 2023, at least one Stand-alone Dental Plan was offered in every state, and thirty-six states offered embedded dental plans. Most counties (63.6 percent) had access to more than five insurers offering adult dental plans, whereas approximately 4 percent had only one insurer offering adult dental plans. Counties in state-based Marketplaces, rural areas, and dentist shortage areas were more likely to be counties with limited dental insurer participation. The net loss of Stand-alone Dental Plans between 2016 and 2023 was more common in state-based Marketplaces and disadvantaged counties. Our findings can inform future policies to improve the dental insurance Marketplace and access to affordable dental care.

This document summarizes the relevant literature for the selection of the initial imaging in five clinical scenarios in patients with suspected or known nonvariceal upper gastrointestinal bleeding (UGIB). These clinical scenarios include suspected nonvariceal UGIB without endoscopy performed; endoscopically confirmed nonvariceal UGIB with clear source but treatment not possible or continued bleeding after endoscopic treatment; endoscopically confirmed nonvariceal UGIB without a confirmed source; suspected nonvariceal UGIB with negative endoscopy; and postsurgical or post-traumatic nonvariceal UGIB when endoscopy is contraindicated. The appropriateness of imaging modalities as they apply to each clinical scenario is rated as usually appropriate, may be appropriate, and usually not appropriate to assist the selection of the most appropriate imaging modality in the corresponding clinical scenarios of nonvariceal UGIB. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation., (Copyright © 2024 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Objective: To describe experiences of Latina women who were currently pregnant or recently gave birth around discrimination, anti-immigrant policies, and community violence during the early COVID-19 pandemic., Design: Qualitative secondary analysis., Setting: Online or phone interviews., Participants: Latina women who were currently pregnant or recently gave birth (N = 26)., Methods: We used reflexive thematic analysis to examine transcribed data from semistructured interviews conducted during the early COVID-19 pandemic with a subgroup of participants enrolled in a larger study related to prenatal care. Participants were English- or Spanish-speaking, Medicaid-eligible, Latina-identifying women who resided in Fresno County, California. We analyzed responses to questions about personal discrimination, the Black Lives Matter movement, and immigration policies using the theoretical frameworks of critical race theory and the political economy of health., Results: We identified four major themes: Avoidance of Community Engagement, Chronic Fear and Vigilance, The Role of Media, and Everyday Discrimination and Injustice., Conclusion: Participant experiences reflect the pervasiveness of fear and socioeconomic inequity and call attention to the racialized structures that affect health and health care access for Latina women. These exposures during the perinatal period may have intergenerational effects. These findings underscore the need for responsive and race-conscious perinatal nursing care for Latina women, assessment of the effect of the current sociopolitical environment on well-being, and policies that support equitable access to health and social care., Competing Interests: Conflict of Interest The authors report no conflicts of interest or relevant financial relationships., (Copyright © 2024 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.)

Background: Debridement, antibiotics, and implant retention (DAIR) is used to manage acute periprosthetic joint infections (PJIs) after total joint arthroplasty (TJA). Given the uncertain success of single or multiple DAIR attempts and possible long-term deleterious effects this treatment can create when trying to treat persistent infection, it is important to understand the frequency with which surgeons in the United States are attempting multiple debridements for PJI and whether those procedures are achieving the desired goal., Question/purposes: In the context of the American Joint Replacement Registry (AJRR), we asked: (1) What proportion of patients who undergo DAIR have only one DAIR, and what percentage of those patients have more than one? (2) Of the patients who undergo one or more DAIR procedures, what is the proportion who progress to additional surgical procedures? (3) What is the cumulative incidence of medical or surgical endpoints related to infection on the affected leg (other than additional DAIR procedures)?, Methods: DAIR procedures to treat PJI, defined by ICD-9/10 and CPT (Current Procedural Technology) codes, reported to the AJRR from 2012 to 2020 were merged with Centers for Medicare and Medicaid Services (CMS) data from 2012 to 2020 to determine the incidence of patients aged 65 and older who underwent additional PJI-related procedures on the same joint. Linking to CMS ensures no loss to follow-up or patient migration to a non-AJRR site. As of 2021, the AJRR captures roughly 35% of all arthroplasty procedures performed in the United States. Of the total 2.2 million procedures in the AJRR, only 0.2% of the procedures were eligible based on our inclusion criteria. Additionally, 61% of the total population is Medicare eligible, and thus, these patients are linked to CMS. Of the 5029 DAIR attempts after a TKA, 46% (2318) were performed in female patients. Similarly, there were a total of 798 DAIR attempts after a THA, and 50% (398) were performed in female patients. For the purposes of decreasing confounding factors, bilateral THAs and TKAs were excluded from the study population. When querying for eligible procedures from 2012 to 2020, the patient population was limited to those 65 years and older, and a subsequent reoperation for infection had to be reported after a primary TJA. This limited the patient population as most infections reported to AJRR resulted in a revision, and we were searching for DAIRs. Although 5827 TJAs were identified as a primary TJA with a subsequent infectious event, more than 65% (3788) of that population did not have a reported event. The following conditions were queried as secondary outcomes after the first DAIR: sepsis, cellulitis, postoperative infection, endocarditis, amputation, knee fusion, resection, drainage, arthrotomy, and debridement. To answer our first and second study questions, we used frequency testing from the available AJRR data. Because of competing risks and issues with incomplete data, we used the cumulative incidence function to evaluate the outcomes specific to study question 3., Results: Of the patients who underwent DAIR, 93% (5406 of 5827) had one DAIR and 8% (421 of 5827) had more than one. Among the DAIR population, at least 35% of TKAs and 38% of THAs were identified as having experienced an additional PJI-related event (an additional surgical procedure on the same joint, sustained an infectious endpoint in the linked CMS-AJRR dataset, or they had died). The cumulative incidence of developing a further medical or surgical condition related to the joint that had the initial DAIR were as follows: 48% (95% CI 42% to 54%) at 8 years after a DAIR following a TKA and 42% (95% CI 37% to 46%) at 4 years after a DAIR following a THA. The timepoints for TKA and THA are different because there are more longitudinal procedure data available for TKAs regarding DAIR procedures than for THAs., Conclusion: In this study, we used data from the AJRR to assess the incidences of single and multiple DAIR attempts and additional surgical- and infection-related sequalae. Continued investigation is required to determine the fate of infected joints that undergo DAIR with regard to ultimate patient outcome. Future cross-sectional studies using large datasets are necessary to assess functional outcomes and determine the risk of persistent infection after DAIR more precisely., Level of Evidence: Level III, therapeutic study., Competing Interests: All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2024 by the Association of Bone and Joint Surgeons.)

Background: States have implemented policies to decrease clinically unnecessary opioid prescribing, but few studies have examined how state policies affect opioid dispensing rate trends for surgical patients., Objective: To examine trends in the perioperative opioid dispensing rates for fee-for-service Medicare beneficiaries and the effects of select state policies., Design and Participants: A retrospective cohort study using 2006 to 2018 Medicare claims data for individuals undergoing surgical procedures for which opioid analgesic treatment is common., Exposures: State policies mandating prescription drug monitoring program (PDMP; PDMP policies) use, initial opioid prescription duration limit (duration limit policies), and mandated continuing medical education (CME; CME pain policies) on pain management., Main Measures: Opioid dispensing rates, days' supply, and the daily morphine milligram equivalent dose (MMED)., Key Results: The percentage of Medicare beneficiaries dispensed opioids in the perioperative period increased from 2007 to 2018; MMED and days' supply decreased over the same period, with significant variation by age, sex, and race. None of the three state policies affected the likelihood of Medicare beneficiaries being dispensed perioperative opioids. However, CME pain policies and duration limit policies were associated with decreased days' supply and decreased MMED in the several years following implementation, respectively., Conclusion: While we observed a slight increase in the rate of Medicare beneficiaries dispensed opioids perioperatively and a substantial decrease in MMED and days' supply for those receiving opioids, state policies examined had relatively modest effects on the main measures. Our findings suggest that these state policies may have a limited impact on opioid dispensing for a patient population that is commonly dispensed opioid analgesics to help control surgical pain, and as a result may have little direct effect on clinical outcomes for this population. Changes in opioid dispensing for this population may be the result of broader societal trends than such state policies., Competing Interests: Declarations: Conflict of Interest: The authors declare that they do not have a conflict of interest. Disclaimer: Drs. Stein and Lai had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.The authors are solely responsible for the content of this article, which does not necessarily represent the official views of the US Federal Government, including the National Institute of Health and National Institute on Drug Abuse., (© 2024. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Background: How state opioid policy environments with multiple concurrent policies affect opioid prescribing to individuals with acute pain is unknown., Objective: To examine how prescription drug monitoring programs (PDMPs), pain management clinic regulations, initial prescription duration limits, and mandatory continued medical education affected total and high-dose prescribing., Design: A county-level multiple-policy difference-in-difference event study framework., Subjects: A total of 2,425,643 individuals in a large national commercial insurance deidentified claims database (aged 12-64 years) with acute pain diagnoses and opioid prescriptions from 2007 to 2019., Main Measures: The total number of acute pain opioid treatment episodes and number of episodes containing high-dose (> 90 morphine equivalent daily dosage (MEDD)) prescriptions., Key Results: Approximately 7.5% of acute pain episodes were categorized as high-dose episodes. Prescription duration limits were associated with increases in the number of total episodes; no other policy was found to have a significant impact. Beginning five quarters after implementation, counties in states with pain management clinic regulations experienced a sustained 50% relative decline in the number of episodes containing > 90 MEDD prescriptions (95 CIs: (Q5: - 0.506, - 0.144; Q12: - 1.000, - 0.290)). Mandated continuing medical education regarding the treatment of pain was associated with a 50-75% relative increase in number of high-dose episodes following the first year-and-a-half of enactment (95 CIs: (Q7: 0.351, 0.869; Q12: 0.413, 1.107)). Initial prescription duration limits were associated with an initial relative reduction of 25% in high-dose prescribing, with the effect increasing over time (95 CI: (Q12: - 0.967, - 0.335). There was no evidence that PDMPs affected high-dose opioids dispensed to individuals with acute pain. Other high-risk prescribing indicators were explored as well; no consistent policy impacts were found., Conclusions: State opioid policies may have differential effects on high-dose opioid dispensing in individuals with acute pain. Policymakers should consider effectiveness of individual policies in the presence of other opioid policies to address the ongoing opioid crisis., (© 2024. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Background: The COVID-19 pandemic necessitated postponement of vascular surgery procedures nationally. Whether procedure volumes have since recovered remains undefined. Therefore, our objective was to quantify changes in procedure volumes and determine whether surgical volume has returned to its prepandemic baseline., Methods: This study was a retrospective cross-sectional study between 2018 and 2023 using the US Fee-for-Service Medicare 5% National Sample as part of the VA Disrupted Care National Project. We studied patients who underwent 1 of 3 procedures: abdominal aortic aneurysm (AAA) repair for intact aneurysms, carotid endarterectomy (CEA), and major lower extremity amputation (LEA). The case volume of each quarter of 2020-2023 was compared to its corresponding prepandemic quarter in 2019. We then performed a subanalysis of these trends by sex, age, and race., Results: We identified 21,031 procedures: 4,411 AAA repair, 8,361 CEA, and 8,259 LEA. The average percent change during the baseline prepandemic period from 2018 to 2019 was -4.3% for AAA repair, -8.5% for CEA, and -2.6% for LEA. Compared to Q2 of 2019, Q2 of 2020 demonstrated that AAA repair procedures decreased by 47%, CEA by 40%, and LEA by 14%. While procedures initially rebounded in Q3 of 2020, volumes did not return to their prepandemic baseline, demonstrating a persistent volume reduction (-16% AAA, -22% CEA, and -11% LEA). Thereafter, procedure counts again declined in Q1 of 2022 (-25% AAA, -34% CEA, and -25% LEA)., Conclusions: Despite a perception that vascular surgical care was singularly disrupted at the outset of the pandemic, there has been a sustained reduction in vascular surgical volume since 2019. Not only have procedure volumes not returned to prepandemic baseline but it also appears that there has been a cumulative incremental impact on overall procedure volume. The impact of these findings on long-term population health remains uncertain and necessitates a better understanding of postpandemic care delivery., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Atherosclerotic cardiovascular disease (ASCVD), a leading cause of mortality and morbidity, is associated with a substantial healthcare and economic burden. Reduction of low-density lipoprotein cholesterol (LDL-C) to guideline-recommended goals is crucial in the prevention or management of ASCVD, particularly in those at high risk. Despite the availability of several effective lipid-lowering therapies (LLTs), up to 80% of patients with ASCVD do not reach evidence-based LDL-C goals. This nonattainment may be due to poor adherence to, and lack of timely utilization of, LLTs driven by a range of variables, including polypharmacy, side effects, clinical inertia, costs, and access issues. Inclisiran was approved by the US Food and Drug Administration in 2021 as a novel, twice-yearly, healthcare provider (HCP)-administered LLT. In-office administration allows HCPs more control of drug acquisition, administration, and reimbursement, and may allow for more timely care and increased patient monitoring. In the USA, in-office administered drugs are considered a Medical Benefit and can be acquired and reimbursed using the "buy-and-bill" process. Buy-and-bill is a standard system for medication administration already established in multiple therapeutic areas, including oncology, vaccines, and allergy/immunology. Initiating in-office administration will involve new considerations for clinicians in the cardiovascular specialty, such as the implementation of new infrastructure and processes; however, it could ultimately increase treatment adherence and improve cardiovascular outcomes for patients with ASCVD. This article discusses the potential implications of buy-and-bill for the cardiology specialty and provides a practical guide to implementing HCP-administered specialty drugs in US clinical practice., (© 2024. The Author(s).)

Study Objectives: Excessive daytime sleepiness is prevalent and overwhelmingly stems from disturbed sleep. We hypothesized that age modulates the association between excessive daytime sleepiness and increased all-cause mortality., Methods: We utilized the Veterans' Health Administration data from 1999-2022. We enrolled participants with sleep related International Classification of Diseases 9/10 codes or sleep services. A natural language processing pipeline was developed and validated to extract the Epworth Sleepiness Scale (ESS) as a self-reported tool to measure excessive daytime sleepiness from physician progress notes. The natural language processing's accuracy was assessed through manual annotation of 470 notes. Participants were categorized into normal-ESS (ESS 0-10) and high-ESS (ESS 11-24). We created 3 age groups: < 50 years, 50 to < 65 years, and ≥ 65 years. The adjusted odds ratio of mortality was calculated for age, body mass index, sex, race, ethnicity, and the Charlson Comorbidity Index, using normal-ESS as the reference. Subsequently, we conducted age stratified analysis., Results: The first ESS records were extracted from 423,087 veterans with a mean age of 54.8 (± 14.6), mean body mass index of 32.6 (± 6.2), and 90.5% male. The adjusted odds ratio across all ages was 17% higher (1.15, 1.19) in the high-ESS category. The adjusted odds ratio s only became statistically significant for individuals aged ≥ 50 years in the high-ESS compared to the normal-ESS category (< 50 years: 1.02 [0.96, 1.08], 50 to < 65 years 1.13[1.10, 1.16]; ≥ 65 years: 1.25 [1.21, 1.28])., Conclusions: High-ESS predicted increased mortality only in participants aged 50 and older. Further research is required to identify this differential behavior in relation to age., Citation: Maghsoudi A, Azarian M, Sharafkhaneh A, et al. Age modulates the predictive value of self-reported sleepiness for all-cause mortality risk: insights from a comprehensive national database of veterans. J Clin Sleep Med . 2024;20(11):1785-1792., (© 2024 American Academy of Sleep Medicine.)

Background: Lung cancer screening guidelines were introduced in the United States in 2013, with variable implementation. This study evaluated temporal diagnostic trends in non-small cell lung cancer (NSCLC) diagnosis since the introduction of these guidelines., Methods: This retrospective cohort analysis used data from the Veterans Administration Corporate Data Warehouse and the National Cancer Database. We evaluated temporal trends in the distribution of NSCLC stage at the time of diagnosis along with differences based on insurance coverage type, including uninsured, privately insured, Medicare, Medicaid, and Veterans Affairs (VA) coverage, with adjustment for clinically relevant variables., Results: Among 1,450,965 patients diagnosed from 2006 to 2020, the proportion of NSCLC cases diagnosed at stage I increased in all insurance groups by 12.74%, 2%, 0.25%, and 2.57% for the VA, Medicare, private insurance, and Medicaid, respectively. If all insurance systems achieved the unadjusted stage distribution seen in the Veterans Health Administration, an additional 45,684 patients would be diagnosed with stage I NSCLC and 65,933 fewer patients would be diagnosed with stage IV disease., Conclusions: For patients with any form of insurance, there has been an increase in the proportion of early-stage NSCLC (stage I and II) and a corresponding decrease in the proportion of stage III and IV since the introduction of national lung cancer screening guidelines. As the largest integrated single-payer health care system in the United States, the VA dramatically outperforms other insurance types, perhaps attributable to universal coverage and robust lung cancer screening programs., Competing Interests: Disclosures Brendan Heiden reports a relationships with Oncocyte Corporation and Eli Lilly & Company that includes: consulting or advisory and employment. Martin Schoen reports a relationship with Pfizer that includes: speaking and lecture fees. Varun Puri reports a relationship with PrecisCa that includes: speaking and lecture fees. Varun Puri (spouse) reports a relationship with Intuitive Surgical Inc that includes: equity or stocks. The other authors have no conflicts of interest to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Background: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair., Methods: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines., Results: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m 2 . Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor., Conclusions: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure., Competing Interests: Disclosures M.F. is a consultant for W. L. Gore & Associates, Cook Medical, Getinge, and ViTAA; and has received research support from Cook Medical, clinical trial support from Centerline Biomedical, W. L. Gore Associates, Cook Medical, and ViTAA; an has stock options in Centerline Biomedical. J.M. has received a research grant from W. L. Gore Associates (granted to University of Colorado). S.H. is a consultant for Cook Medical, Terumo Aortic, and W. L. Gore & Associates (all honoraria paid to USC, no personal income); is on the scientific advisory board for Cook Medical, Terumo Aortic, W. L. Gore & Associates, and Vestek; and has received educational grants from W. L. Gore & Associates and Terumo Aortic, M.M. is on the advisory board of W. L. Gore & Associates. B.S. is a consultant for W. L. Gore & Associates, Cook Medical, Endologix, and Astute Imaging. C.T. has received consulting fees and research support from Cook Medical, W. L. Gore & Associates, and Philips Healthcare. B.M. reports payments to Mayo Clinic, with no personal income, for work on the advisory boards of Cook Medical and Medtronic; as a consultant for Cook Medical and W. L. Gore Associates; and research grants from W. L. Gore Associates and Cook Medical. G.O. reports a consulting agreement with Cook Medical, W. L. Gore Associates, GE Healthcare, and Centerline biomedical; and a research grant from GE Healthcare., (Published by Elsevier Inc.)

Background: Racial and ethnic minoritized groups report disproportionately lower trust in the health-care system. Lower health-care system trust is potentially related to increased exposure to racial discrimination in medical settings, but this association is not fully understood. We examined the association between racial discrimination in medical care and trust in the health-care system among people with and without a personal cancer history., Methods: We examined racial discrimination and trust in a nationally representative American adult sample from the Health Information National Trends Survey 6. Racial discrimination was defined as any unfair treatment in health care on the basis of race or ethnicity. Trust in the health-care system (eg, hospitals and pharmacies) was grouped into low, moderate, and high trust. Multinomial logistic regression models were used to compare low and moderate trust relative to high trust in the health-care system and estimate odds ratios (ORs) and 95% confidence intervals (CIs)., Results: A total of 5813 respondents (15% with a personal cancer history) were included; 92% (n = 5355) reported no prior racial discrimination experience during medical treatment. Prior experiences of racial discrimination were positively associated with low (OR = 6.12, 95% CI = 4.22 to 8.86) and moderate (OR = 2.70, 95% CI = 1.96 to 3.72) trust in the health-care system relative to high trust. Similar associations were observed when stratifying by personal cancer history., Conclusion: Respondents who reported racial discrimination during medical encounters had lower trust in the health-care system, especially respondents with a personal cancer history. Our findings highlight the need to address racial discrimination experiences during medical care to build patient trust and promote health-care access., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: This study aimed to compared Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety, depression, and anger item bank among Korean, US and Dutch general population., Methods: Between December 2021 and January 2022, we surveyed representative Korean participants (N = 2699). Then we compared the mean T-scores of PROMIS anxiety, depression, and anger full items bank among Korean, US (N = 1696) and the Dutch (N = 1002) populations. Differential item-functioning (DIF) analyses were also performed. We also compared each score by age group, sex, presence of comorbidities, and general health status., Results: In Korean, the mean T-scores for anxiety, depression, and anger were 45.3 (standard deviation [SD] = 11.6), 48.4 (SD = 11.2), and 44.9 (SD = 12.6), respectively. Among the general population in Korea, patients aged 35-44 years and those with comorbidities had higher anxiety, depression, and anger scores. In the DIF analyses between the US and Korean populations, 28%, 32%, and 45% were flagged for uniform or non-uniform DIF in anxiety, depression and anger, respectively., Conclusions: Considering the cultural differences, we recommend using a harmonized approach that includes country-specific reference values while retaining a standardized core set of items to enable cross-country comparability., (© 2024 The Author(s). International Journal of Methods in Psychiatric Research published by John Wiley & Sons Ltd.)

Goals: We assessed satisfaction with and adherence to off-label corticosteroids in patients with eosinophilic esophagitis (EoE) in the United States., Background: EoE is a chronic inflammatory disease for which there are currently no US Food and Drug Administration-approved swallowed topical corticosteroids., Study: This noninterventional, cross-sectional, web-based survey included caregivers of adolescents (aged 11 to 17 y) and adults (aged 18 years or older) with a self-reported [or caregiver-reported (adolescents)] physician diagnosis of EoE who were receiving corticosteroids. Participants were recruited through 2 nonprofit, patient advocacy groups. The 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) was used to assess satisfaction across effectiveness, convenience, and global satisfaction domains (scale: 1 to 100 per domain); higher scores indicated greater satisfaction. The 4-item Morisky Green Levine Medication Adherence Scale (MGL-4) was used to assess adherence; an MGL-4 score of <3 indicated adherence. Participants also reported reasons for nonadherence., Results: Overall, 201 participants (caregivers of adolescents, n=98; adults, n=103) were included in this study. Mean TSQM-9 scores indicated low satisfaction with off-label corticosteroids across all 3 satisfaction domains in adolescents (≤61.1) and adults (≤55.7). Slightly fewer adolescents (37.1%) than adults (40.8%) were considered adherent. Forgetfulness was the most frequently reported reason for nonadherence; some patients chose not to take their medications, owing to poor palatability (adolescents), difficulty taking medications at specific times (adults), or feeling depressed/overwhelmed (adolescents and adults)., Conclusions: Satisfaction with and adherence to off-label corticosteroids were low in this web-based survey of adolescents and adults with EoE in the United States., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

The Abbreviated New Drug Application (ANDA) is used for the regulatory submission of generic drugs, which are pharmaceutical equivalents to brand-name drugs and distributed without patent protection. Different countries have their own regulatory requirements for the approval of generic drugs, enforced by authorities such as the CDSCO in India, EDQM in Europe, and USFDA in the United States. This review aims to compare the regulatory processes and requirements for generic drug approval in India, Europe, and the US, highlighting key differences and challenges. The involvement of regulatory authorities in the drug development process is crucial for expediting approval and addressing queries, helping to minimize delays. The Common Technical Document (CTD) format is employed across regions to harmonize submission requirements. This study underscores the differences in dossier submission for generics across the three regions, illustrating India's position in the global generic drug approval landscape. By comparing approval requirements, this work provides insight into the hurdles India must overcome to streamline its approval process. The ANDA allows generic manufacturers to submit bioequivalence studies, using the original innovator's safety and efficacy data. However, obtaining approval simultaneously from multiple regulatory authorities remains a challenging task. Careful review of regulatory documents by skilled personnel can reduce regulatory queries, ultimately accelerating the market launch of generic drugs. This review provides a comprehensive overview of the generic drug approval process, emphasizing the need for harmonization and improved efficiency in India's regulatory framework.

Importance: The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients., Objective: To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to better characterize panel decision-making and identify steps for improvement., Design, Setting, and Participants: This qualitative survey study included 36 questions that were mailed to FDA device panelists regarding their opinions on the influence of sources of information, pivotal trial design, quality of evidence, panel composition and internal deliberative process, time allocation, and impartiality of the FDA. The survey was mailed to the members of all 18 FDA device panels in January and February 2017. Data were collected from January to May 2017 and analyzed from 2018 to 2019., Exposures: Respondents read and returned the aforementioned paper survey, while nonrespondents did not., Main Outcomes and Measures: The main outcomes included panel members' perceptions, and their implications for process improvement. χ2 or Fisher exact tests were used to test differences between subgroups., Results: Of 64 of 92 panel members who responded (69.6%), 38 of 64 (59.4%) were male, 3 of 63 (4.8%) were Black respondents, 46 of 63 (73.0%) were White respondents, and 36 of 60 (60.0%) were in academic practice. The mean (range) panel service was 6.8 (1-22) years with 3.9 (1-19) meetings attended. Overall, respondents considered information presented by the FDA unbiased, and 28 of 61 (45.9%) believed that pivotal trials were frequently well-designed, 55 of 62 respondents (88.7%) suggested FDA consult panel members preemptively regarding trial design and 54 of 64 (84.4%) regarding the device label. Most indicated that prior FDA approval of another device serving the same medical purpose (43 of 62 [69.4%]) or approval in other countries with comparable regulatory regimes, such as Canada and Europe (39 of 62 [62.9%]), would make them more likely to recommend approval. Respondents rated written information (50 of 60 [83.3%]), live presentations (43 of 58 [74.1%]), and prior professional knowledge (41 of 60 [68.3%]) as the most important sources of information in deciding whether to recommend approval. Additionally, 52 of 58 respondents (89.7%) recommended that a panel member-only executive session would allow more clarity and honesty in deliberations, and 33 of 59 (55.9%) believed a three-fourths majority appropriate for recommending approval, which would be a deviation from the current system in which an overall vote is reported without designation of a vote threshold., Conclusions and Relevance: In this survey study of FDA device panel members, respondents wanted improved study designs, more relevant clinical data, including from other countries, involvement of panelists in study design and device label development, and inclusion of an executive session. Demographically, panels could be made more diverse.

Background: At present, 4 prescription therapies have been approved by the US Food and Drug Administration for the treatment of chronic idiopathic constipation (CIC) in adults., Objectives: To compare persistence with and adherence to prucalopride vs 3 other prescription medications for CIC in a US population., Methods: This retrospective, observational cohort study used data from the IBM MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases (January 2015-June 2020). Inclusion criteria were patients (aged ≥18 years) with at least 1 prescription fill for prucalopride, lubiprostone, linaclotide, or plecanatide on or after April 2, 2019 (commercial availability of prucalopride), and at least 1 constipation-related diagnosis code. Persistence was assessed by time to discontinuation, and adherence was assessed by the proportion of days covered (PDC) and the proportion of patients who achieved PDC of at least 80%. Adjusted hazard ratios (HRs) for discontinuation and odds ratios for adherence were calculated., Results: A total of 14,700 patients (mean age = 48.3 years; female = 81.9%) were included (prucalopride, n = 675; lubiprostone, n = 1,591; linaclotide, n = 11,105; plecanatide, n = 1,329). After adjusting for confounding factors, the HRs for discontinuation were significantly higher for all comparator medications compared with prucalopride after 2 months (HR [95% CI]: lubiprostone, 1.70 [1.48-1.95]; linaclotide, 1.25 [1.10-1.41]; plecanatide, 1.31 [1.13-1.51], all P < 0.001). The unadjusted mean (SD) PDC was 0.53 (0.32) with prucalopride compared with 0.41 (0.31); P less than 0.001 with lubiprostone, 0.48 (0.31), P less than 0.05 with linaclotide, and 0.48 (0.29), P = 0.98 with plecanatide. The comparator medications were all associated with lower odds of achieving PDC of at least 80% relative to prucalopride (odds ratio [95% CI]: lubiprostone, 0.52 [0.40-0.69], P < 0.001; linaclotide, 0.73 [0.58-0.93], P = 0.009; plecanatide, 0.70 [0.53-0.93], P = 0.015)., Conclusions: The findings of this study indicate that prucalopride has higher treatment persistence and adherence compared with other CIC prescription medications. This research represents the first instance of a real-world claims study showcasing such outcomes.

Objective: This study aimed to document and empirically evaluate the physical environment strategies used by emergency departments (EDs) to address the challenges posed by the COVID-19 pandemic; and to develop recommendations for managing future crises. Background: Emergency departments made significant environmental modifications in responding to the COVID-19 pandemic but these modifications and the decision-making processes were seldomly studied. Methods: In this in-depth qualitative case study, a multidisciplinary research team conducted semistructured interviews with 11 professionals of various roles in environmental responses to the pandemic at a large urban ED in the U.S. Qualitative content analysis generated codes and code categories from the data as well as a conceptual framework. Design documents and photographic documentation were used to cross-check the interview data. Results: The ED faced challenges in making rapid changes with limited information and resources. Physical barriers separating patients, air filtration, airflow control, and alternative care spaces were key physical environmental strategies implemented. Among them, the physical separation of patients was perceived to be most effective, followed by air quality control measures. Interviewees recommended flexibility in building design (self-contained zones, negative pressure and air filtration in all patient rooms, pandemic mode of air ventilation system), and an all-inclusive bottom-up decision-making process. Concerns included ventilation, security, communication strategies, and workplace ergonomics. Conclusion: The physical environment constitutes an important part of ED pandemic response and the proactive preparation for future crises. Hospitals should consider the ED environment's role in pandemic response, including ventilation capability, security visibility, and functionality for staff., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Due to improvements in recognition and management of their multisystem disease, the long-term survival of infants, children, and adolescents with trisomy 21 and congenital heart disease now matches children with congenital heart disease and no genetic condition in many scenarios. Although this improved survival is a triumph, individuals with trisomy 21 and congenital heart disease have unique and complex care needs in the domains of physical, developmental, and psychosocial health, which affect functional status and quality of life. Pulmonary hypertension and single ventricle heart disease are 2 known cardiovascular conditions that reduce life expectancy in individuals with trisomy 21. Multisystem involvement with respiratory, endocrine, gastrointestinal, hematological, neurological, and sensory systems can interact with cardiovascular health concerns to amplify adverse effects. Neurodevelopmental, psychological, and functional challenges can also affect quality of life. A highly coordinated interdisciplinary care team model, or medical home, can help address these complex and interactive conditions from infancy through the transition to adult care settings. The purpose of this Scientific Statement is to identify ongoing cardiovascular and multisystem, developmental, and psychosocial health concerns for children with trisomy 21 and congenital heart disease from birth through adolescence and to provide a framework for monitoring and management to optimize quality of life and functional status.