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Kavita Gajria,1 Lulu K Lee,2 Natalia M Flores,2 Ernesto Aycardi,1 Sanjay K Gandhi1 1Global Health Economics Research, Teva Pharmaceuticals, New York, NY, USA; 2Health Outcomes Practice, Kantar Health, Foster City, CA, USA Background: While studies have demonstrated the economic burden of migraines in terms of quality of life, health care resource use (HRU), and costs, there exists a notable paucity of data comparing such outcomes among migraineurs with nausea and vomiting (N/V) and those without. The current study aimed to address this gap.Methods: This was a retrospective study using data from the 2013 US National Health and Wellness Survey, a cross-sectional, internet-based survey. Respondents self-reported their migraine with or without N/V along with demographics and outcomes including depression (Patient Health Questionnaire total score; PHQ-9), sleep problems (11-item total score of sleep problems), HRU (number of physician visits, emergency room [ER] visits, and hospitalizations) and Work Productivity and Activity Impairment-General Health Scale (WPAI-GH), and associated mean annual costs. Generalized linear models, adjusting for covariates, assessed the burden of N/V on all outcomes.Results: Among all migraineurs (N=7,855), 73.4% were female, mean age was 41.82 years old, and 57.6% reported experiencing N/V. Adjusting for covariates, migraineurs with N/V vs without N/V had higher mean PHQ-9 scores (7.91 vs 7.02, p

Lulu K Lee,1 Nozomi Ebata,2 Patrick Hlavacek,3 Marco DiBonaventura,4 Joseph C Cappelleri,5 Alesia Sadosky3 1Health Outcomes Practice, Kantar Health, Foster City, CA, USA; 2Neuroscience & Pain Medical Affairs, Pfizer Japan Inc., Tokyo, Japan; 3Global Health & Value, Pfizer Inc., 4Health Outcomes Practice, Kantar Health, New York, NY, 5Statistics, Pfizer Inc., Groton, CT, USA Purpose: The aim of this study was to examine the health and economic burden associated with fibromyalgia among adults in Japan.Materials and methods: Data from the 2011–2014 Japan National Health and Wellness Survey (n=115,271), a nationally representative survey of adults, were analyzed. The greedy matching algorithm was used to match the respondents who self-reported a diagnosis of fibromyalgia with those not having fibromyalgia (n=256). Generalized linear models, controlling for covariates (eg, age and sex), examined whether the respondents with fibromyalgia differed from matched controls based on health status (health utilities; Mental and Physical Component Summary scores from Medical Outcomes Study: 12-item Version 2 and 36-item Version 2 Short Form Survey), sleep quality (ie, sleep difficulty symptoms), work productivity (Work Productivity and Activity Impairment Questionnaire – General Health Version 2.0), health care resource use, and estimated annual indirect and direct costs (based on published annual wages and resource use events) in Japanese yen (¥). Results: After adjustment for covariates, respondents with fibromyalgia relative to matched controls scored significantly lower on health utilities (adjusted means =0.547 vs 0.732), Mental Component Summary score (33.15 vs 45.88), and Physical Component Summary score (39.22 vs 50.81), all with P

Lulu K Lee,1 Amir Goren,1 Natalie N Boytsov,2 Craig F Donatucci,2 Kevin T McVary3 1Health Outcomes Practice, Kantar Health, New York, NY, 2US Real World Outcomes Research, Eli Lily & Company, Indianapolis, IN, 3Division of Urology, Southern Illinois University School of Medicine, Springfield, IL, USA Objective: Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) frequently co-occur in men aged ≥40, along with lower urinary tract symptoms (LUTS) secondary to BPH. Given little real-world evidence on treatment use or satisfaction with treatment for concurrent BPH/LUTS and/or ED, this study examined medication regimens and differences in satisfaction and health-related quality of life (HRQoL) across regimens among men with concurrent BPH and ED. Methods: A cross-sectional study was conducted using an Internet survey of participants recruited through an online panel. Respondents (N=736) included men (aged ≥40) who self-reported a diagnosis of both ED and BPH with prescription treatment in the past 3 months for both conditions. Treatment satisfaction (eg, convenience and ease of planning) and HRQoL (eg, International Prostate Symptom Score, sleep quality) were self-reported. Generalized linear models examined the association of regimen with treatment satisfaction and HRQoL, adjusting for covariates (eg, age and comorbidities). Results: Final analyses included participants (N=507) using: tadalafil once-daily monotherapy (22%), tadalafil for ED with an alternate BPH therapy (36%), or another phosphodiesterase type-5 inhibitor (PDE5-I) combination (41%). These groups represented the major categories of treatment regimens found in the sample, excluded participants with ambiguous regimens, and were aligned with current standard of care for BPH and ED. Overall, patients reported moderate levels of BPH and a moderate-to-severe degree of ED. Tadalafil monotherapy patients had higher treatment satisfaction scores and greater reported ease of treatment planning and convenience than PDE5-I combination patients. No significant intergroup differences were found on HRQoL. Conclusion: A majority of patients (59%) took tadalafil alone or in combination for BPH/ED treatment. Tadalafil monotherapy patients reported greater treatment satisfaction than patients taking PDE5-I combination therapy. Higher satisfaction for both effectiveness and convenience of once-daily tadalafil may inform both patient and clinician decisions regarding pharmacotherapy regimens. Keywords: once-daily tadalafil, alpha1-adrenergic blockers, 5-alpha-reductase inhibitors, International Prostate Symptom Score, treatment convenience, treatment satisfaction, Treatment Satisfaction Questionnaire for Medication

Background: To investigate the impact of concurrent chemoradiotherapy (CCRT) on stage IV rectum cancer.Methods: Between 2000 and 2011, 297 consecutive patients diagnosed with stage IV rectum cancer (synchronous metastasis) were enrolled. Cox proportional hazard analyses were used for prognostic factors determination, and the Kaplan-Meier method was used for survival analyses. Propensity scores with the one-to-one nearest-neighbor matching model were used to select matched patients for validation studies.Results: In total, 63 patients received CCRT and 234 did not. The patients in the CCRT group were younger, had more low-lying lesions, and had more T4 lesions, lung metastases, metastasectomies, and oxaliplatin-based upfront chemotherapy. Before propensity-score matching, a younger age (HR = 0.662, P = 0.016), lower carcinoembryonic antigen (CEA) level (≤20 ng/ml) (HR = 0.531, P = 0.001), no metastasectomy (HR = 3.214, P < 0.001), and no CCRT (HR = 1.844, P = 0.019) were independent prognostic factors after controlling for other confounding factors. After matching, only CEA and metastasectomy, but not CCRT, were independent prognostic factors. The survival benefit of CCRT was restricted to patients who undergo subsequent metastasectomy.Conclusions: Upfront CCRT only provided a survival benefit in patients with stage IV rectum cancer who undergo subsequent metastasectomy. [ABSTRACT FROM AUTHOR]

1 Until recently, phenotyping the N-acetyltransferase enzyme had been restricted to distinguishing the slow acetylators from the rapid. Further separation of the heterozygous rapid phenotype from the homozygous rapid phenotype has only been possible by detailed pharmacokinetic studies using sulphadimidine and necessitating prolonged plasma sampling. 2 A simple method of deriving the basic pharmacokinetic parameters is presented. In this study of ten healthy volunteers, one urine sample and hourly plasma sampling over only 5 h enabled calculation of the total body (TBC) and metabolic clearances (MC) wih enough accuracy to distinguish the three (slow, intermediate and rapid) acetylator phenotypes. The spread of the distribution for the elimination rate constant was however too wide to enable their clear separation. [ABSTRACT FROM AUTHOR]

Objective: To examine differences in pediatric fracture prevalence, severity, and mechanisms of injury before and during the COVID-19 pandemic., Methods: This is a subanalysis of data from a multicenter, cross-sectional study of all injury-related visits to 40 urban pediatric emergency departments (EDs) for children younger than 18 years occurring January 2019-December 2020. ED visits for injuries including fractures were identified by International Classification of Diseases, Tenth Revision codes. Comparative analyses of patient demographics, fracture prevalence, severity, and mechanisms of injury for March 17, 2019, to December 31, 2019 (pre-COVID), versus March 15, 2020, to December 31, 2020 (during COVID), were performed., Results: Fracture-related visits comprised 21.0% (n = 123,684) of all injury visits (n = 589,083) during the study period. There were 16,190 fewer fracture-related visits (-23.2%) in 2020 than 2019. There were differences in the proportion of fracture-related visits by age (P < 0.0001), with increases in children younger than 5 years and decreases in children 5 to 18 years old. There were higher proportions of visits in 2020 among female patients, White children, non-Hispanic children, and those with private insurance (P < 0.0001, respectively). Patients with fractures in 2020 were more severely injured, with higher proportions of hospitalizations (P < 0.0001), intensive care unit admissions (P < 0.0001), deaths (P = 0.007), and higher injury severity scores (P < 0.0001). Fracture mechanisms shifted to more motor vehicle crashes, bicycles, and firearms in 2020 (P < 0.0001)., Conclusions: Despite a decrease in fracture-related visits to urban pediatric EDs during the early COVID-19 pandemic, there was an increase in the proportion of ED visits for children younger than 5 years and higher severity injuries. These findings highlight injury epidemiology pattern shifts that occurred during the pandemic. Identifying higher-risk populations for fracture may help guide targeted education and prevention efforts., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Pediatric trauma centers have had challenges meeting the American College of Surgeons criteria for screening and intervening for alcohol with adolescent trauma patients. The study objective was to conduct an implementation trial to evaluate the effectiveness of the Science to Service Laboratory (SSL) implementation strategy in improving alcohol and other drugs (AOD) screening, brief intervention, and referral to treatment (SBIRT) delivery at pediatric trauma centers., Methods: Using a stepped wedge cross-over cluster randomized design, 10 US pediatric trauma centers received the SSL implementation strategy to deliver SBIRT with admitted adolescent (12-17 years old) trauma patients. The strategy adapted three core SSL elements: didactic training, performance feedback, and facilitation. The main outcome measured was SBIRT reach. Data were collected from each center's electronic health record (EHR) during pre- and post-implementation wedges (2018-2022)., Results: EHR data from 8461 adolescent patients were extracted. Aggregated across all sites, the reach of screening with a validated AOD screening tool increased significantly from 25.2% (95% CI: 23.9, 26.5%) of adolescents during pre-implementation to 47.7% (95% CI: 46.3%, 49.2%) post-implementation. There was variability of change across centers. Brief interventions continued to be delivered at high levels to identified adolescents. Referral to primary care providers for further AOD discussion or referral to specialty service for adolescents with high risk use did not improve post-implementation and remained low., Conclusions: The SSL implementation strategy can be successfully utilized by pediatric trauma centers to improve AOD screening, but challenges exist in connecting adolescents for continuation of AOD discussions after discharge., Level of Evidence: Level II, Therapeutic., Competing Interests: Conflicts of interest None., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Core genome single-nucleotide polymorphism phylogeny was used to characterise a nosocomial outbreak caused by ST-80 Vancomycin-resistant Enterococcus faecium (VREf). It identified 22 of 25 epidemiologically related isolates as belonging to an outbreak cluster. The use of Fourier-transform infrared (FT-IR) spectroscopy with a cluster-defining cut-off of 0.071 resulted in the correct classification of 21 of 22 phylogenetically related isolates in a single cluster. It successfully distinguished three phylogenetically unrelated isolates from the outbreak cluster, along with five ST-80 unrelated control isolates, and five isolates from a previous outbreak in May 2023, yielding only one mischaracterised environmental isolate. These findings support the potential use of FT-IR spectroscopy as a rapid screening tool to assist outbreak investigations. Notably, this study is the first to focus on the performance of FT-IR spectroscopy in the epidemiological analysis of VREf isolates with the same sequence type., Competing Interests: Declaration of Competing Interest All authors have no conflict of interest., (Copyright © 2024. Published by Elsevier Ltd.)

Importance: Adverse birth outcomes in the US, including preterm birth and low birth weight, are strongly tied to socioeconomic disadvantage and disproportionately impact infants of Black mothers. Increasing investments in social programs represents a potential policy approach to addressing disparities in birth outcomes., Objective: To examine state-level associations of government expenditures on social programs with rates of preterm birth and low birth weight both overall and by race., Design, Setting, and Participants: This cross-sectional, ecological study was conducted among liveborn infants in the 50 US states between January 1, 2011, and December 31, 2019. Data analysis was performed from May 2022 to May 2024., Exposures: Yearly state and local government expenditures per low-income person on social programs in the following categories: state refundable Earned Income Tax Credit; cash assistance; childcare assistance; housing and community development; and public health., Main Outcomes and Measures: Yearly state-level rates of preterm birth (gestational age <37 weeks) and low birth weight (<2500 g)., Results: From January 1, 2011, to December 31, 2019, there were 35.1 million live births in the US, of which 3.4 million (9.8%) were preterm and 2.8 million (8.1%) were low birth weight. Median (IQR) state social expenditures per low-income person were $1546 ($1074-$2323). Greater total state social expenditures were associated with lower overall rates of preterm birth (adjusted prevalence ratio [aPR] for every increase of $1000 per low-income person, 0.99; 95% CI, 0.97-0.999) but not with overall rates of low birth weight. In secondary analyses, greater state social expenditures were associated with lower preterm birth rates for infants of Black mothers (aPR, 0.96; 95% CI, 0.92-0.999). Greater state expenditures specifically on cash assistance (aPR, 0.64; 95% CI, 0.43-0.94) and housing and community development (aPR, 0.91; 95% CI, 0.84-0.98) were associated with lower preterm birth rates for infants of Black mothers., Conclusions and Relevance: In this cross-sectional, ecological study, greater state-level expenditures on social programs were associated with reduced rates of preterm birth, particularly for infants of Black mothers. State and local governments may consider bolstering investments in cash assistance and housing and community development to address maternal and infant health disparities.

Background An artificial intelligence (AI)-based method for measuring intraprostatic tumor volume based on data from MRI may provide prognostic information. Purpose To evaluate whether the total volume of intraprostatic tumor from AI-generated segmentations (V AI ) provides independent prognostic information in patients with localized prostate cancer treated with radiation therapy (RT) or radical prostatectomy (RP). Materials and Methods For this retrospective, single-center study (January 2021 to August 2023), patients with cT1-3N0M0 prostate cancer who underwent MRI and were treated with RT or RP were identified. Patients who underwent RT were randomly divided into cross-validation and test RT groups. An AI segmentation algorithm was trained to delineate Prostate Imaging Reporting and Data System (PI-RADS) 3-5 lesions in the cross-validation RT group before providing segmentations for the test RT and RP groups. Cox regression models were used to evaluate the association between V AI and time to metastasis and adjusted for clinical and radiologic factors for combined RT (ie, cross-validation RT and test RT) and RP groups. Areas under the receiver operating characteristic curve (AUCs) were calculated for V AI and National Comprehensive Cancer Network (NCCN) risk categorization for prediction of 5-year metastasis (RP group) and 7-year metastasis (combined RT group). Results Overall, 732 patients were included (combined RT group, 438 patients; RP group, 294 patients). Median ages were 68 years (IQR, 62-73 years) and 61 years (IQR, 56-66 years) for the combined RT group and the RP group, respectively. V AI was associated with metastasis in the combined RT group (median follow-up, 6.9 years; adjusted hazard ratio [AHR], 1.09 per milliliter increase; 95% CI: 1.04, 1.15; P = .001) and the RP group (median follow-up, 5.5 years; AHR, 1.22; 95% CI: 1.08, 1.39; P = .001). AUCs for 7-year metastasis for the combined RT group for V AI and NCCN risk category were 0.84 (95% CI: 0.74, 0.94) and 0.74 (95% CI: 0.80, 0.98), respectively ( P = .02). Five-year AUCs for the RP group for V AI and NCCN risk category were 0.89 (95% CI: 0.80, 0.98) and 0.79 (95% CI: 0.64, 0.94), respectively ( P = .25). Conclusion The volume of AI-segmented lesions was an independent, prognostic factor for localized prostate cancer. © RSNA, 2024 Supplemental material is available for this article.

Background: Thoracic surgery and one-lung ventilation in young children carry significant risks. Approaches to one-lung ventilation in young children include endobronchial intubation (mainstem intubation) and use of a bronchial blocker. We hypothesized that endobronchial intubation is associated with a greater prevalence of airway complications compared to use of a bronchial blocker., Methods: The Multicenter Perioperative Outcomes Group database was queried from 2004 to 2022 for one-lung ventilation cases in children, 2 months to 3 years of age, inclusive. Airway notes and free-text comments were manually reviewed for airway complications. Documented airway complications were considered the primary outcome and were divided into "Moderate" and "Critical." Moderate airway complications were bronchial blocker or endotracheal tube movement leading to loss of isolation, hypoxemia requiring ventilatory intervention, bronchial blocker migration into the trachea, significant impairment of ventilation, and other. Critical complications included reintubation or airway replacement intraoperatively, complete endotracheal tube occlusion, cardiac arrest or airway-related bradycardia, and procedure aborted due to an airway issue. An adjusted propensity score-matched analysis was then used to assess the impact of a bronchial blocker on the outcomes of moderate and critical complications., Results: After exclusions, 704 patients were included in the primary analysis. In unadjusted analyses, no statistically significant difference was observed in moderate airway complications between endobronchial intubation and bronchial blocker cohorts: 37 of 444 (8.3%; 95% confidence interval [CI], 5.9%-11.3%) vs 28 of 260 (10.8%; 95% CI, 7.3%-15.2%) with P = .281. In the unadjusted analysis, the prevalence of critical airway complications was significantly higher in the endobronchial intubation cohort compared to the bronchial blocker cohort: 28 of 444 (6.3%; 95% CI, 4.2%-9.0%) vs 5 of 260 (1.9%; 95% CI, 0.6%-4.4%) with P = .008. In the propensity-matched cohort analysis, endobronchial intubation was associated with a slightly increased risk of critical complications compared to use of a bronchial blocker: 14 of 243 (5.8%; 95% CI, 2.8%-8.7%) vs 5 of 243 (2.1%; 95% CI, 0.3%-3.8%) with P = .035., Conclusions: Endobronchial intubation might be associated with a slightly increased risk of critical airway complications compared to use of a bronchial blocker in young children undergoing thoracic surgery and one-lung ventilation. Further, prospective studies are needed before a definitive change in practice is recommended., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 International Anesthesia Research Society.)

Background: Sudden unexpected infant death (SUID) continues to be a leading cause of death in infants in the United States (US), with significant disparities by race and socio-economic status. Infant safe sleep behaviors are associated with decreasing SUID risk, but challenges remain for families to practice these routinely. The objective of this program was to implement and evaluate a novel approach for an infant safe sleep pilot program built upon partnerships between hospitals and community-based organizations (CBOs) serving pregnant and parenting families in at-risk communities., Methods: Community Partnership Approaches to Safe Sleep (CPASS) was a prospectively implemented infant safe sleep program. CPASS included children's hospitals partnered with CBOs across five US cities: Portland, OR, Little Rock AR, Chicago, IL, Birmingham, AL, and Rochester, NY. The program consisted of (1) monthly learning community calls; (2) distribution of Safe Sleep Survival Kits; and (3) surveys of sites and families regarding program outcomes. Survey measures included (1) site participation in CPASS activities; (2) recipients' use of Safe Sleep Kits; and (3) recipients' safe sleep knowledge and behaviors., Results: CPASS learning community activities were consistently attended by at least two representatives (1 hospital-based, 1 CBO-based) from each site. Across the five sites, 1002 safe kits were distributed over 9 months, the majority (> 85%) to families with infants ≤ 1 month old. Among participating families, 45% reported no safe sleep location before receipt of the kit. Family adherence to nighttime safe sleep recommendations included: (1) no bedsharing (M 6.0, SD 1.8, range 0-7); (2) sleep on back (M 6.3, SD 1.7, range 0-7); and (3) sleep in a crib with no blankets/toys (M 6.0, SD 2.0, range 0-7). Site interviews described how participation in CPASS influenced safe sleep conversations and incorporated local data into counseling. Hospital-CBO relationships were strengthened with program participation., Conclusions: The CPASS pilot program provides a new, innovative model built on hospital-community partnerships for infant safe sleep promotion in SUID-impacted communities. CPASS reached families before their infant's peak age risk for SUID and empowered families with knowledge and resources to practice infant safe sleep. Important lessons learned included improved ways to center and communicate with families., (© 2024. The Author(s).)