Background: U.S. FDA's Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative leverages large electronic health records and administrative claims data to conduct active surveillance for CBER-regulated products.
View Article and Find Full Text PDFBackground And Objective: Recent studies have proposed computed tomography (CT) criteria for posterior ligamentous complex (PLC) injury: disrupted if ≥2 CT findings, indeterminate if single finding, and intact if 0 CT findings. The study aims to validate the CT criteria for PLC injury externally.
Methods: Three level 1 trauma centers enrolled 614 consecutive patients with acute thoracolumbar fractures (T1-L5) who received CT and MRI.
Background: Sexual orientation discrimination increases the risks of negative health outcomes for sexual minorities. Previous studies have found increased rates of eating disorder symptoms in sexual minority individuals, which is attributable to minority stress and discrimination that they experience. Emerging research suggests relationships between sexual orientation discrimination and eating disorder symptoms.
View Article and Find Full Text PDFThe associations of adverse childhood experiences (ACEs) with blood pressure in adulthood are inconclusive. Similarly, the association between ACEs and blood pressure earlier in the life course is understudied. This study aims to assess the associations of ACEs with blood pressure among early adolescents.
View Article and Find Full Text PDFPurpose: This study aims to investigate the prospective associations between four types of perceived discrimination (country of origin, race and ethnicity, sexual orientation, and weight) and the development of manic symptoms in a diverse, nationwide sample of adolescents aged 9-14 years in the U.S.
Methods: We analyzed prospective cohort data from the Adolescent Brain Cognitive Development Study (N = 7466; ages 9-14 years at Year 1 or 2 in 2017-2020; 48.
Objectives: To evaluate the prevalence of weight discrimination (the perception of being treated unfairly based on weight) and its sociodemographic associations among early adolescents aged 10 to 13 in the United States.
Methods: We analyzed cross-sectional data from the Adolescent Brain Cognitive Development (ABCD) Study in Year Two (2018-2020). Multivariable logistic regression analyses were conducted, with perceived weight discrimination as the dependent variable and age, sex, sexual orientation, race and ethnicity, body mass index (BMI) category, household income, and highest parental education level as adjusted independent variables.
Background: Substance use in youth remains a pressing problem in the United States. Existing studies have shown the importance of neuropathways responsible for affective response and reward motivation in adolescents' substance use initiation and maintenance. However, limited observational studies have explored the relationship between aspects of behavioral motivation traits and the likelihood of substance use initiation in adolescents.
View Article and Find Full Text PDFPurpose: Emerging research evidence suggests positive relationships between higher screen time and eating disorders. However, few studies have examined the prospective associations between screen use and eating disorder symptoms in early adolescents and how problematic screen use may contribute to symptom development.
Methods: We analyzed prospective cohort data from the Adolescent Brain Cognitive Development (ABCD) Study (N = 10,246, 2016-2020, ages 9-14).
Background: To assess the prevalence of various media parenting practices and identify their associations with early adolescent screen time and problematic social media, video game, and mobile phone use.
Methods: Cross-sectional data from Year 3 of the Adolescent Brain Cognitive Development (ABCD) Study (2019-2022) that included 10,048 adolescents (12-13 years, 48.3% female, 45.
Objective: To investigate the prevalence and sociodemographic associations of online dating in a demographically diverse U.S. national cohort of early adolescents.
View Article and Find Full Text PDFThe association between body mass index (BMI) and binge-eating disorder (BED) is well-established. However, data on the extent to which BMI is associated with progression from binge-eating behavior into BED among adolescents are limited, which was the aim of this investigation. Participants were 9964 U.
View Article and Find Full Text PDFBackground: While safety of influenza vaccines is well-established, some studies have suggested potential associations between influenza vaccines and certain adverse events (AEs). This study examined the safety of the 2022-2023 influenza vaccines among U.S.
View Article and Find Full Text PDFBackground: Current hemovigilance methods generally rely on survey data or administrative claims data utilizing billing and revenue codes, each of which has limitations. We used electronic health records (EHR) linked to blood bank data to comprehensively characterize red blood cell (RBC) utilization patterns and trends in three healthcare systems participating in the U.S.
View Article and Find Full Text PDFBackground: COVID-19 vaccines are authorized for use in children in the United States; real-world assessment of vaccine effectiveness in children is needed. This study's objective was to estimate the effectiveness of receiving a complete primary series of monovalent BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine in US children.
Methods: This cohort study identified children aged 5-17 years vaccinated with BNT162b2 matched with unvaccinated children.
Importance: Active monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes that may not be identified in prelicensure trials.
Objective: To conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population.
Design, Setting, And Participants: This cohort study evaluated 21 prespecified health outcomes after exposure before early 2023 to BNT162b2, mRNA-1273, or NVX-CoV2373 ancestral monovalent COVID-19 vaccines in children aged 6 months to 17 years by applying a near-real-time monitoring framework using health care data from 3 commercial claims databases in the US (Optum [through April 2023], Carelon Research [through March 2023], and CVS Health [through February 2023]).
Introduction: Results of retrospective studies examining the relationship between prolactin increasing antipsychotics and incident breast cancer have been inconsistent. This study assessed the association between use of high prolactin increasing antipsychotics (HPD) and the incidence of breast cancer using best practices in pharmacoepidemiology.
Methods: Using administrative claims data from the MarketScan Medicaid database, schizophrenia patients initiating antipsychotics were identified.
Purpose: To determine the impact of magnetic resonance imaging (MRI) on fracture classification for thoracic spine fractures (TSFs) compared to computed tomography (CT) alone.
Methods: This study was a retrospective review of 63 consecutive patients with TSFs who underwent CT and MRI within ten days of injury. Three reviewers classified all fractures according to the AOSpine Classification and the Thoracolumbar AOSpine Injury severity score (TLAOSIS).
Background: The association between obesity and cardiovascular disease (CVD) remains unclear, particularly for those with established CVD risk factors. We analyzed follow-up data from the Aichi Workers' Cohort Study. We studied the association between the degree of obesity and risk of CVD and its subtypes specifically among individuals with hypertension, hyper-low-density lipoprotein (LDL)-cholesterolemia, or diabetes.
View Article and Find Full Text PDFObjective: Although vertical laminar fracture (VLF) is generally considered a severity marker for thoracolumbar fractures (TLFs), its exact role in decision-making has never been established. This scoping review aims to synthesize the research on VLF's role in the decision-making of TLFs.
Methods: A systematic review was conducted following PRISMA guidelines.
Background: Increased risk of thrombosis with thrombocytopenia syndrome (TTS) following adenovirus vector-based COVID-19 vaccinations has been identified in passive surveillance systems. TTS incidence rates (IRs) in the United States (U.S.
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