Cytokine Dynamics in Action: A Mechanistic Approach to Assess Interleukin 6 Related Therapeutic Protein-Drug-Disease Interactions.

Understanding cytokine-related therapeutic protein-drug interactions (TP-DI) is crucial for effective medication management in conditions characterized by elevated inflammatory responses. Recent FDA and ICH guidelines highlight a systematic, risk-based approach for evaluating these interactions, emphasizing the need for a thorough mechanistic understanding of TP-DIs. This study integrates the physiologically based pharmacokinetic (PBPK) model for TP (specifically interleukin-6, IL-6) with small-molecule drug PBPK models to elucidate cytokine-related TP-DI mechanistically.

Evaluation and adaptation of a two-way text messaging intervention in the WIC breastfeeding peer counseling program: A qualitative analysis.

Breastfeeding (BF) is vital for maternal and infant health, yet post-hospital discharge support remains a challenge. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) provides BF peer counseling prenatally and up to 1-year postpartum among low-income women in the United States. The Lactation Advice Through Texting Can Help (LATCH) intervention is an evidence-based two-way text messaging intervention that provides BF education and support in the WIC peer counseling program.

Smoking behavior and social identity: Correlates of Phantom Smoking Among Lesbian, Gay, Bisexual, Transgender, and Other Sexual and Gender Diverse Young Adults.

Introduction: LGBTQ+ populations and people who smoke face stigma. This may lead to distancing oneself from smoking-related stigma by becoming phantom smokers (i.e.

Generating campaign awareness with digital media: exploring factors associated with awareness of and receptivity to FDA's Fresh Empire tobacco prevention campaign.

Introduction: We explore factors that were associated with awareness of and receptivity to FDA's Fresh Empire tobacco public education campaign.

Methods: Evaluation data were 10,674 survey responses from 5,129 unique respondents who identified with the Hip Hop peer crowd between 2016 and 2019. The sample was predominantly non-Hispanic Black and Hispanic youth.

Supporting diversity in clinical trials: the equitable breakthroughs in medicine site maturity model.

Background: Among the most powerful barriers to broader inclusion of diverse participants in clinical trials are social determinants of health, trustworthiness of health care providers and research institutions, and competing pressures on potential participants. Nevertheless, current tools to assess organizational capabilities for clinical trial diversity focus primarily on trial infrastructure, rely solely on quantitative self-reported data, and lack meaningful assessment of capabilities related to community engagement.

Methods: The Equitable Breakthroughs in Medicine (EQBMED) initiative developed a holistic, collaborative, site-driven formative model and accompanying assessment to catalog sites' current capabilities and identify opportunities for growth in both conducting industry-sponsored clinical trials and enriching diversity of those trials.

The Validity of Impressions as a Media Dose Metric in a Tobacco Public Education Campaign Evaluation: Observational Study.

Background: Evaluation research increasingly needs alternatives to target or gross rating points to comprehensively measure total exposure to modern multichannel public education campaigns that use multiple channels, including TV, radio, digital video, and paid social media, among others. Ratings data typically only capture delivery of broadcast media (TV and radio) and excludes other channels. Studies are needed to validate objective cross-channel metrics such as impressions against self-reported exposure to campaign messages.

Individual and social-environmental factors among young drivers informing decisions to ride with an impaired driver and drive impaired: A sequential mixed methods assessment.

Objective: To contextually examine facilitators of young driver decisions to ride with an impaired driver (RWI) or drive while impaired (DWI).

Methods: Data were from the NIH's NEXT Generation Health Study (NEXT), a 7-year longitudinal nationally representative study with a U.S.

Predictors of Cigar, Cigarillo, and Little Cigar Initiation Among Hip Hop-Identifying Youth.

Background: We explored predictors of cigar product initiation among Hip Hop-identifying U.S. youth using data from the U.

Barriers to Optimal Clinician Guideline Adherence in Management of Markedly Elevated Blood Pressure: A Qualitative Study.

Importance: Hypertension poses a substantial public health challenge. Despite clinical practice guidelines for hypertension management, clinician adherence to these guidelines remains suboptimal.

Objective: To develop a taxonomy of suboptimal adherence scenarios for severe hypertension and identify barriers to guideline adherence.

Modeling of drinking and driving behaviors among adolescents and young adults in the United States: Complexities and Intervention outcomes.

Alcohol-impaired driving is a formidable public health problem in the United States, claiming the lives of 37 individuals daily in alcohol-related crashes. Alcohol-impaired driving is affected by a multitude of interconnected factors, coupled with long delays between stakeholders' actions and their impacts, which not only complicate policy-making but also increase the likelihood of unintended consequences. We developed a system dynamics simulation model of drinking and driving behaviors among adolescents and young adults.

A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator.

The Simcyp Simulator is a software platform widely used in the pharmaceutical industry to conduct stochastic physiologically-based pharmacokinetic (PBPK) modeling. This approach has the advantage of combining routinely generated in vitro data on drugs and drug products with knowledge of biology and physiology parameters to predict a priori potential pharmacokinetic changes in absorption, distribution, metabolism, and excretion for populations of interest. Combining such information with pharmacodynamic knowledge of drugs enables planning for potential dosage adjustment when clinical studies are feasible.

Belzutifan: a novel therapeutic for the management of von Hippel-Lindau disease and beyond.

The identification of the gene and its role in regulating the hypoxia-inducible factor signaling pathway has helped to revolutionize the treatment of renal cell carcinoma (RCC). Belzutifan is a novel small-molecule inhibitor of hypoxia-inducible factor 2α which has demonstrated efficacy in treating von Hippel-Lindau (VHL) disease, earning regulatory approvals for this indication. There is also early evidence for efficacy in sporadic RCC.

Hospital healthcare resource utilization and costs for chimeric antigen T-cell therapy and autologous hematopoietic cell transplant in patients with large B-cell lymphoma in the United States.

The efficacy of chimeric antigen receptor (CAR) T-cell therapy for large B-cell lymphoma (LBCL) is well-established. This study, using the Premier PINC AI Healthcare Database, assessed hospital costs and healthcare resource utilization (HRU) between CAR T-cell therapy and autologous hematopoietic cell transplant (AHCT) for 733 LBCL patients from 01/01/2017-04/30/2021 (166 CAR T and 567 AHCT from 37 US hospital systems. CAR T-cell therapy had higher index costs but lower non-pharmacy costs, shorter hospital stays, lower ICU utilization than AHCT.

Promising Themes for Electronic Cigarette Prevention Campaigns for Youth and Young Adults.

Introduction: Electronic cigarettes (e-cigarettes) are the most widely used tobacco product by youth and young adults in the United States. Effective prevention campaigns require the identification of appropriate content focus for message construction.

Aims And Methods: A sample of 2622 youth and young adults ages 15-24 were recruited through social media advertisements and completed an online survey.

Key Considerations for the Treatment of Advanced Breast Cancer in Older Adults: An Expert Consensus of the Canadian Treatment Landscape.

The prevalence of breast cancer amongst older adults in Canada is increasing. This patient population faces unique challenges in the management of breast cancer, as older adults often have distinct biological, psychosocial, and treatment-related considerations. This paper presents an expert consensus of the Canadian treatment landscape, focusing on key considerations for optimizing selection of systemic therapy for advanced breast cancer in older adults.

Exploring the impact of ethnicity on drug pharmacokinetics using PBPK models: A case study with lansoprazole in Japanese subjects.

Aims: The aim of this study is to demonstrate the use of PBPK modelling to explore the impact of ethnic differences on drug PK.

Methods: A PBPK model developed for lansoprazole was used to predict the clinical PK of lansoprazole in Japanese subjects by incorporating the physiological parameters of a Japanese population into the model. Further verification of the developed Japanese population with clinical studies involving eight other CYP substrates-omeprazole, ticlopidine, alprazolam, midazolam, nifedipine, cinacalcet, paroxetine and dextromethorphan-was also carried out.

Shared and distinct parental influences on teen impaired driving in rural and suburban contexts: A mixed methods study of young drivers.

Objective: To explore shared and distinct parental influences on rural and suburban adolescents' riding with an impaired driver (RWI) and driving while impaired (DWI) behaviors during high school.

Methods: Participants in the NEXT Generation Health Study (NEXT) were classified into four RWI/DWI trajectory classes (i.e.

Risk stratification of acute kidney injury (AKI) following ureteral stent insertion for colorectal surgery.

Introduction And Objectives: Ureteral stents have long been utilized during colorectal resections to assist in the identification of ureters intraoperatively and mitigate risk of ureteral injury. As these procedures have shifted toward robot-assisted laparoscopic methods, lighted stents have increasingly been used. The incidence of acute kidney injury (AKI) following bilateral ureteral stent placement has been reported to be as high as 41.

Do adolescent trajectories of riding with an impaired driver and driving impaired predict similar behaviors in early adulthood?

Background: A recent study shows four trajectories of riding with an impaired driver (RWI) and driving while impaired (DWI) from adolescence to emerging adulthood. We examined prospective associations of adolescent RWI/DWI trajectory class with early adulthood RWI/DWI behavior.

Methods: Data were from the NEXT Generation Health Study (NEXT), a nationally representative longitudinal study (N = 2783) beginning with a 10th-grade cohort completing 7 annual assessment waves (W1-W7) between 2010 and 2016 and a later follow-up mixed methods study.

Longitudinal perspectives of riding with a cannabis-impaired driver.

Objective: To explore decisions and perceptions of engaging in riding with a cannabis-impaired driver (RWI) during high school and young adulthood to build context around RWI-cannabis events.

Methods: Participants were sampled from the NEXT Generation Health Study (NEXT), a 7-year national cohort study of adolescent health behaviors. Four RWI and driving while impaired (DWI) trajectories classes (i.

Illness Perception and the Impact of a Definitive Diagnosis on Women With Ischemia and No Obstructive Coronary Artery Disease: A Qualitative Study.

Background: Ischemia and no obstructive coronary artery disease (INOCA) disproportionately impacts women, yet the underlying pathologies are often not distinguished, contributing to adverse health care experiences and poor quality of life. Coronary function testing at the time of invasive coronary angiography allows for improved diagnostic accuracy. Despite increased recognition of INOCA and expanding access to testing, data lack on first-person perspectives and the impact of receiving a diagnosis in women with INOCA.

Perspectives of Clinicians and Staff at Community-Based Opioid Use Disorder Treatment Settings on Linkages With Emergency Department-Initiated Buprenorphine Programs.

Importance: An increasing number of emergency departments (EDs) are initiating buprenorphine for opioid use disorder (OUD) and linking patients to ongoing community-based treatment, yet community-based clinician and staff perspectives regarding this practice have not been characterized.

Objective: To explore perspectives and experiences regarding ED-initiated buprenorphine among community-based clinicians and staff in geographically distinct regions.

Design, Setting, And Participants: This qualitative study reports findings from Project ED Health, a hybrid type 3 effectiveness-implementation study designed to evaluate the impact of implementation facilitation on ED-initiated buprenorphine with referral to ongoing medication treatment.

Perspectives on National Institutes of Health Funding Requirements for Racial and Ethnic Diversity Among Medical Scientist Training Program Leadership.

Importance: Since 1964, the National Institutes of Health (NIH) has funded the Medical Scientist Training Program (MSTP) MD-PhD program at medical schools across the US to support training physician-scientists. Recent studies have suggested that MSTPs have consistently matriculated more students from racial and ethnic backgrounds historically underrepresented in science than MD-PhD programs without NIH funding; however, the underlying basis for the increased diversity seen in NIH-funded MSTPs is poorly understood.

Objective: To investigate how administrators and faculty perceive the impact of MSTP status on MD-PhD program matriculant racial and ethnic diversity.