Jacobs Institute of Women's Health
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Sociodemographic Disparities in Surgical Timing and Outcomes of Mandibular Distraction Osteogenesis
No full textBACKGROUND: Mandibular distraction osteogenesis (MDO) is an effective procedure for alleviating upper airway obstruction in infants with micrognathia, yet the role of sociodemographic factors in MDO care and outcomes remains underexplored. This study aims to uncover potential disparities in patient care related to MDO. METHODS: This retrospective review analyzed patients who underwent MDO at a tertiary children\u27s hospital between 2004 and 2023. This study assessed the Area Deprivation Index (ADI), median household income, unemployment rates, insurance status, race/ethnicity, and primary language. Outcome measures included age at surgery, length of hospital stay, readmission rates, and postoperative complications. RESULTS: A total of 133 patients underwent MDO. Patients in lower-income and higher-unemployment cohorts had greater rates of MDO failure and a higher incidence of operative site infections. White/Caucasian patients were the youngest at the time of surgery (3.6 wk) compared with Hispanic (4.5 wk), Asian (5.4 wk), and Black/African American patients (5.6 wk) (P=0.031). Black/African American patients had the highest readmission rate (75.0%, P=0.008) and the longest median hospital stay (120.0 days, P=0.007). No significant differences in outcome variables were observed between cohorts based on ADI, insurance status, or primary language. DISCUSSION: Patients from low socioeconomic neighborhoods experienced higher MDO failure rates and higher postoperative infection rates. Moreover, Black/African American patients underwent surgery later, had higher readmission rates, and faced longer hospital stays. Recognizing and addressing these disparities is crucial for providing equitable care
Data-driven profiles of behavior in pediatric medical disorders
No full textBehavioral impairment is comorbid with pediatric medical conditions and impacts academic, social-emotional, and medical outcomes. In prior work, we applied graph-theory analysis to parent-report measures of behavior to derive multidimensional profiles in a multi-site database of children with psychiatric disorders and healthy controls (comprised of participants from Children\u27s National Hospital, Georgetown University, and Kennedy Krieger Institute), and identified three unique profiles characterized by relative weaknesses in (a) metacognition, (b) emotion regulation, and (c) inhibition. In this study, we also found broadly the same behavioral profiles within a large (N = 466) cross-sectional clinical database collected at Children\u27s National Hospital from 2014 to 2018 comprised of children with pediatric medical conditions affecting the central nervous system. A support vector machine (SVM) classification derived from the psychiatric sample was then applied to the medical sample and had high (but not perfect) accuracy, suggesting subtle differences in profile composition between medical and nonmedical populations, particularly within the Inhibit subgroup. These findings lend further support to the existence of three transdiagnostic profiles, representing unique targets for personalized intervention. However, findings also highlight that the etiology of behavior problems (psychiatric versus medical) may matter
Perceptions of non-sugar sweeteners (NSS) and front-of-package NSS labels among parents of preschool and school-aged children in Brazil
No full textOBJECTIVE: To describe Brazilian parents\u27 perceptions of non-sugar sweeteners (NSS) in beverages consumed by children and their preferences for NSS front-of-package labels (FOPLs). DESIGN: A qualitative-driven mixed-methods embedded design was used. Seven focus groups with parents of children explored perceptions of NSS. Thematic analysis was conducted on transcripts. Participants also completed a closed-ended survey assessing familiarity with NSS-containing beverages, ability to identify NSS on labels, and perceptions of NSS FOPLs. Survey responses were summarized using descriptive statistics. SETTING: Public and private schools and early childhood education centers in urban areas of two municipalities in the State of São Paulo, Brazil. PARTICIPANTS: Forty parents of children aged 2-5 and 6-11, across seven focus groups. RESULTS: About 35% of participants reported their children consumed at least one NSS-containing beverage weekly in the past month; 17% reported daily consumption. Parents expressed a preference for natural products and confusion over the term edulcorantes (Portuguese for NSS). They shared concerns about health effects of both sugar and NSS, particularly for children. NSS were seen as acceptable in specific cases, such as diabetes. Most parents supported FOPL like Mexico\u27s, stating not recommended for children. In the survey, 85% correctly identified beverages with NSS, but 82% misclassified non-NSS ingredients (e.g., sugar syrup, caramel) as NSS. The Mexico-style FOPL was preferred by 95%, who found it helpful and easy to understand. CONCLUSIONS: An FOPL clearly indicating NSS presence, especially one recommending against consumption by children, may help parents make informed choices and reduce children\u27s intake of NSS-containing beverages
Hot and Cold HCC: Uncoupling Viral Oncogenesis and Therapy
No full textHepatocellular carcinoma (HCC) is rising in incidence globally. It is the sixth most common cancer and the third leading cause of cancer-related mortality worldwide. Infection with hepatitis B and/or C virus is a significant risk factor for developing HCC. These viruses exert their carcinogenicity in both direct and indirect ways, including induction of immune exhaustion with prolonged antigen exposure. Therefore, the best therapeutic option for HCC is prevention, i.e., Hepatitis B vaccination and treatment of viral hepatitis. However, when HCC develops because of viral hepatitis or other etiologies, long-lasting effects on the immune system remain even after viral suppression, which affect the response to HCC therapy. Recent studies have suggested a hot and cold model for HCC, in which the two kinds of HCC tumors have very distinct tumor microenvironments. The microenvironment for hot HCC makes these tumors amenable to immunotherapy with checkpoint inhibitors. Therefore, converting cold HCC tumors to hot tumors may make them susceptible to immunotherapy. In this review, we provide an overview of HCC epidemiology and prevention, an overview of tumor microenvironments of hot and cold HCC, the proposed mechanisms for converting cold tumors to hot tumors, and a concise summary of the evidence for combination checkpoint inhibitor therapy for HCC
From acute to chronic: the PREVENT protocol for understanding pain progression after emergency department visits
No full textAIM: The Pain Recognition and Evaluation to Validate Effective Neck and back Treatment (PREVENT) study aims to identify cognitive, behavioral, and treatmentrelated predictors of chronic musculoskeletal pain (CMP) development following emergency department (ED) care for acute neck or back pain after trauma. BACKGROUND: CMP is a leading cause of global disability, yet early risk factors for its development remain poorly characterized, particularly in ED settings. This prospective observational study will recruit 246 adult patients presenting with acute (≤ 4 weeks) neck or back pain after a recent trauma. Pain beliefs - measured using pain and attitude questionnaires - serve as the primary independent variable. Mediating variables include catastrophic thinking, fear-avoidance behaviors, low physical activity, poor recovery expectations, and low self-efficacy for pain management. Covariates include demographics, social determinants of health, mental health disorders, and high-risk substance use. The primary outcome is the presence of CMP at six months, defined as pain on most or every day for at least three months. Participants will complete follow-ups at 1, 3, and 6 months. Multivariable logistic regression, mediation analyses, and interaction testing will explore effects of pain beliefs on CMP development. As a secondary aim, a subset of participants will complete Think Aloud cognitive interviews to assess response process validity for the Neck Pain Attitudes Questionnaire (Neck-PAQ), a region-specific adaptation of the Back Pain Attitude Questionnaire, analyzed using a deductive content analysis framework. DISCUSSION: This study is among the first to investigate the cognitive and behavioral predictors of pain chronification in the ED. Ethical approval has been obtained from The George Washington University Institutional Review Board. Findings will inform the design of targeted, ED-based screening and intervention strategies, including adaptation of a pain-specific Screening, Brief Intervention, and Referral to Treatment (SBIRT) model. Results will be disseminated through peer-reviewed publications, conferences, and stakeholder engagement
High-grade astrocytoma with piloid features resected with an exoscopic supracerebellar infratentorial approach: illustrative case
No full textBACKGROUND: High-grade astrocytoma with piloid features (HGAP) was recently added to the WHO 2021 CNS classification system among the group of circumscribed astrocytic gliomas. These tumors present with high-grade piloid histology with similarities to glioblastoma. HGAPs in the pineal region become particularly challenging due to its deep location and proximity to deep venous structures, the midbrain, and the thalamus. Herein, the authors present the case of a patient with an HGAP located in the pineal region. The tumor was resected using an exoscopic supracerebellar/infratentorial approach. OBSERVATIONS: A 69-year-old man presented with a pineal gland mass causing obstructive hydrocephalus. Resection using an exoscope revealed an HGAP. Postoperatively, he developed posterior fossa syndrome but was discharged without neurological deficits after 30 days. LESSONS: HGAP, a distinct glioma subtype identified in 2021, presents a mix of low- and high-grade features. It shares histological traits with pilocytic astrocytoma and glioblastoma, requiring DNA methylation profiling for diagnosis. Radiologically, these lesions have a T2-FLAIR mismatch and uneven post-gadolinium enhancement. Treatment is still uncertain, although adjuvant chemoradiation therapy with temozolomide may be used. The prognosis is poor, with a 5-year survival rate of approximately 50%. For pineal region locations, the exoscope offers enhanced magnification, depth perception, and ergonomic benefits, improving surgical precision. https://thejns.org/doi/10.3171/CASE25390
Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial
No full textIMPORTANCE: There is an unmet need for long-term, safe, effective, and hormone-free treatments for menopausal symptoms, including vasomotor symptoms (VMS) and sleep disturbances. OBJECTIVE: To evaluate the 52-week efficacy and safety of elinzanetant, a dual neurokinin-targeted therapy, for treating moderate to severe VMS associated with menopause. DESIGN, SETTING, AND PARTICIPANTS: OASIS-3 was a double-blind, placebo-controlled, randomized phase 3 clinical trial that was conducted at 83 sites in North America and Europe from August 27, 2021, to February 12, 2024, and included postmenopausal women aged 40 to 65 years who were seeking treatment for moderate to severe VMS (no requirement for a minimum number of VMS events per week). The data were analyzed on March 11, 2024. INTERVENTION: Once-daily oral elinzanetant, 120 mg, or matching placebo for 52 weeks. MAIN OUTCOMES AND MEASURES: The primary outcome was mean change from baseline to week 12 in the frequency of daily moderate to severe VMS, which was analyzed using a mixed model with repeated measures. Secondary end points included changes over 52 weeks in measures evaluating sleep disturbance and the effect on menopause-related quality of life. Exploratory end points included mean changes over 50 weeks in frequency and severity of daily moderate to severe VMS. Exploratory and secondary end points were analyzed using descriptive statistics. Safety was also assessed. RESULTS: Overall, 313 women (mean [SD] age, 54.6 [4.7] years; 51 [16.3%] were Black or African American, and 240 [76.7%] were White individuals; 34 [10.9%] were Hispanic or Latina) were randomized to receive elinzanetant and 315 (mean [SD] age, 54.9 [5.0] years; 44 [14.0%] Black or African American, 34 [10.8%] Hispanic or Latina, and 253 [80.3%] White individuals) to receive placebo. At week 12, the mean change from baseline in daily moderate to severe VMS frequency was -5.4 (95% CI, -6.3 to -4.5) for elinzanetant and -3.5 (95% CI, -4.1 to -2.9) for placebo; the least-squares mean difference for elinzanetant vs placebo was -1.6 (95% CI, -2.0 to -1.1; P \u3c .001). Although no statistical hypotheses were defined, nor was the study powered to detect between-group differences for the secondary and exploratory end points, descriptive analyses showed numerical advantages for elinzanetant vs placebo for improving VMS frequency and severity over 50 weeks and sleep disturbances and menopause-related quality of life over 52 weeks. Regarding safety, elinzanetant was not associated with hepatotoxic effects, endometrial hyperplasia, or meaningful changes in bone density or bone turnover markers. Treatment-related adverse events were more common with elinzanetant than placebo (30.4% vs 14.6%); the most frequent were somnolence, fatigue, and headache. CONCLUSIONS AND RELEVANCE: The OASIS-3 randomized clinical trial expanded on findings from the 26-week OASIS-1 and OASIS-2 trials, exploring the use of elinzanetant over a longer duration and in a broader population. Elinzanetant shows promise as a treatment for moderate to severe VMS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05030584
Unravelling the diabetes discrepancy : The presence of chronic complications is a hallmark of worse short-term outcomes in patients with diabetes mellitus after transcatheter aortic valve replacement
No full textBACKGROUND: In transcatheter aortic valve replacement (TAVR), there is a notable diabetes discrepancy , where worse/better/similar outcomes were all found for patients with diabetes mellitus (DM). Such divergent findings pose a challenge for clinicians to accurately assess the risks for DM patients undergoing TAVR. We hypothesized the presence of chronic complications could be linked to worse post-TAVR outcomes in DM patients. Therefore, this study aimed to compare the short-term outcomes of TAVR between DM patients with chronic complications (DM-CC), those without complications (DM-NCC), and non-diabetic individuals (non-DM). METHODS: Patients who underwent TAVR were identified in National Inpatient Sample database from Q4 2015 to 2020. In-hospital post-TAVR outcomes were compared between DM-CC, DM-NCC, and non-DM. Multivariable logistic regression was used to adjust for demographics, socioeconomic status, primary payer status, hospital characteristics, transfer status, admission status, comorbidities and relevant diagnoses, and access site. RESULTS: There were 22,168 DM patients (9388 DM-CC and 12,780 DM-NCC) and 36,682 non-DM patients underwent TAVR. DM-CC were found to have worse outcomes than non-DM, which included adjusted risks of cardiac, neurological, pulmonary, and renal system complications, wound complications, hemorrhage, longer length of stay (LOS), and higher hospital charges. However, compared to non-DM, DM-NCC had lower in-hospital mortality, cardiac and renal system complications, infection, and superficial wound complications, as well as shorter LOS. CONCLUSIONS: The presence of diabetic chronic complications could be a hallmark for worse short-term outcomes after TVAR, which may unravel the long-debated diabetes discrepancy in TAVR and provide insights into preoperative risk stratification for DM patients
Prevalence and Trajectories of Perinatal Anxiety and Depression in a Large Urban Medical Center
No full textIMPORTANCE: Perinatal depression and anxiety are common yet underdiagnosed and undertreated. There are limited data on screening rates, severity, and treatment, and thus an urgent need to estimate accurately perinatal depression and anxiety over time, to inform timely and efficacious interventions. OBJECTIVE: To evaluate screening and treatment rates, prevalence, and symptom trajectories over time of perinatal depression and anxiety in a large urban medical center. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included electronic health records of all patients who gave birth at NewYork-Presbyterian (NYP)/Weill Cornell Medical Center or NYP Lower Manhattan Hospital between December 1, 2020, and February 1, 2024. In March 2023, a mandatory Edinburgh Postnatal Depression Scale (EPDS) screening policy was implemented in 3 clinics covering 35% of deliveries in the hospital. EXPOSURE: Completion of mental health screening during the perinatal period. MAIN OUTCOMES AND MEASURES: The study included 3 primary mental health measures: depression severity (Patient Health Questionnaire-9 [PHQ-9]), anxiety severity (Generalized Anxiety Disorder-7 [GAD-7]), and perinatal depression severity (EPDS). Percentage of women screened, prevalence of clinically meaningful symptoms, as well as rates and frequency of mental health services were examined. Furthermore, symptom changes 1 year before and after delivery were tested using mixed effects models, and whether patient characteristics and mental health services were associated with symptom change was determined. RESULTS: The study included data from medical records of 27 393 women who gave birth during the study period. The final sample included 3051 women (mean [SD] age, 34.3 [5.2] years; age range, 14-54 years) who completed perinatal depression or anxiety screening within 1 year before and after birth. A total of 723 women (3.0%) were administered depression screening (PHQ-9), and 472 (2.0%) completed anxiety (GAD-7) screening. Following a mandatory screening policy, EPDS screening rates increased from 1.0% (274 women) before March 2023 to 14.2% (2304 women) after March 2023. Of those screened, 23.2% (95% CI, 21.7%-24.8%) reported clinically meaningful depression symptoms and 8.8% (95% CI, 7.2%-10.8%) endorsed suicidality; 17.1% of women (523 women) screened received mental health services. Treated women were mostly seen 4 months before and after birth for psychosocial interventions, had faster depression reductions over time (PHQ-9, F1,1504 = 9.6; P = .002), and a sustained decline in depression severity postpartum, compared with untreated women (F1,5166 = 33.8; P \u3c .001). CONCLUSIONS AND RELEVANCE: These findings underscore the need for routine and consistent screening, monitoring, and treatment of perinatal depression and anxiety. Women who received mental health services had faster reductions in depression over time, highlighting the potential impact for scalable and efficacious interventions during this critical period
Content Analysis of Derived Intoxicating Cannabis Vape Product Attributes and Marketing In an Online Retail Environment
No full textINTRODUCTION: The 2018 U.S. Farm Bill unintentionally resulted in the proliferation of derived intoxicating cannabis vape products (DICVPs), raising concerns about associated health risks. To inform prevention efforts, this study analyzed the product attributes and marketing features of DICVPs sold online, particularly features that could attract youth or lower risk perception. METHODS: In 2023, product attributes and descriptions of 490 flavored DICVPs were extracted from two online retail websites. In 2024, two trained coders thematically coded product descriptions for their product marketing features. RESULTS: Overall, 95 unique brands and 26 unique intoxicating cannabinoids were identified. The most frequent marketing features overall were vape product design and use (99.0%), including vaping satisfaction, discreetness, convenience, and use instructions. Regulation and compliance messages (91.6%) were also prevalent, including lab testing for additives and/or chemicals, health warnings, hemp-derived labels, references to the Farm Bill, and U.S. Food and Drug Administration approval statements. Other prominent themes included: flavor and sensation claims (79.6%, i.e., flavor variety, fruit flavors); psychoactive effect claims (43.3%, e.g., potency or expected user experience); product quality claims (38.4%, e.g., quality, natural, purity ); and other positive effect claims (33.9%, e.g., mood enhancement, relaxation). DISCUSSION: The DICVP online marketplace is highly fragmented with a variety of brands and intoxicating compounds. Common marketing strategies promoting appealing flavors and positive vaping experiences may increase their appeal to young people. Features related to product legality and quality may reduce perceived risks and barriers to using products. Continuous monitoring of the DICVP marketplace is needed to inform policymaking