Enhancing the clinical research workforce: a collaborative approach with human resources.

Jobs for clinical research professionals (CRPs) have grown increasingly complex over the past 20+ years. This is due largely to additional administrative burden for investigators, study teams, sponsors, Clinical Research Organizations (CROs), and sites, particularly Academic Medical Centers (AMCs). Furthermore, National Institutes of Health (NIH) has reduced capacity to effectively fund research recognizing this is dependent on the overall congressional budget, which creates greater pressure for clinician scientists to secure external support.

Municipal smoke-free laws and preterm birth.

Background: Smoking during pregnancy and prenatal secondhand smoke exposure increase the risk of preterm birth. As Kentucky has the second highest rate of smoking in the United States and no statewide smoke-free law, an examination of the effect of municipal smoke-free legislation on preterm birth is warranted.

Objective: This study used state-level live birth data and county-level municipal smoke-free legislation status to assess the association between the presence and strength of smoke-free laws and the likelihood of preterm birth.

PATH to understanding cannabis and nicotine initiation and co-use among emerging adults.

Objectives: The purpose of this study was to describe the characteristics and age of initiation of nicotine and cannabis use, with a particular focus on the emerging adult period (ages 18-24 years) and concurrent use of nicotine with cannabis.

Design: A secondary analysis of Population Assessment of Tobacco and Health (PATH).

Sample: 32,078 participants from a nationally representative study of tobacco use and health outcomes.

Longitudinal Examination of Prenatal Tobacco Switching Behaviors and Birth Outcomes, Including Electronic Nicotine Delivery System (ENDS) and Dual Use.

Introduction: In the US, approximately 8% of pregnant women smoke, and 5-11.9% currently use ENDS products. The health effects of ENDS use are debated; however, most contain nicotine which is known to cause adverse perinatal outcomes.

Behavioral and Enhanced Perinatal Intervention (B-EPIC): A randomized trial targeting tobacco use among opioid dependent pregnant women.

Background: Opioid use during pregnancy is a significant public health issue. The standard of care for treating opioid use disorder during pregnancy includes medications for opioid disorder (MOUD). However, tobacco use often goes unaddressed among pregnant women on MOUD.

ENDS use among college students: Salivary biomarkers and persistent cough.

Though e-cigarette aerosol has been associated with altered lung cell function, few studies have examined the effects of use on immune response and respiratory symptoms. The purpose of this study was to examine if recent persistent cough or cytokine levels are related to Electronic Nicotine Delivery Systems (ENDS) use in college students. In April 2019, 61 undergraduate students at the University of Kentucky completed surveys and provided a salivary sample to evaluate cytokine levels (Interleukin (IL-) 2, 4, 6, 8, 10, 12, 13 and TNFα, INFγ), using quota sampling to obtain comparable numbers of ENDS users and non-ENDS users.

Perceptions, Characteristics, and Behaviors of Cigarette and Electronic Cigarette Use among Pregnant Smokers.

Introduction: Smoking during pregnancy is a primary risk factor for adverse perinatal outcomes. Although electronic cigarette (e-cigarette) use has increased, reasons for and behaviors of use are not fully understood. The purpose of this study, composed exclusively of pregnant current smokers, was to describe perceptions of health risks associated with e-cigarette use among pregnant women, describe the use patterns of pregnant dual users (defined as those who simultaneously use conventional/combustible cigarettes and e-cigarettes), and examine smoking-related behaviors between conventional-only (defined as those smoking combustible cigarettes but not e-cigarettes) and dual users.

Electronic nicotine delivery systems and pregnancy: Recent research on perceptions, cessation, and toxicant delivery.

Electronic nicotine delivery systems (ENDS), which includes e-cigarettes (ECIGs), are a rapidly-expanding class of products that heat a liquid (which may or may not contain nicotine) to produce an aerosol. The variation of ECIG components is extensive as are their effects on users. Epidemiological data show that while both adults and youth use ECIGs, use among youth has increased dramatically in recent years.

Associations of first trimester co-use of tobacco and Cannabis with prenatal immune response and psychosocial well-being.

Purpose: This study aims to describe the association of first trimester co-use of tobacco and cannabis with maternal immune response and psychosocial well-being, relative to tobacco use only.

Methods: A preliminary midpoint analysis included 138 pregnant women with biologically verified tobacco use, 38 of whom (28%) also tested positive for recent cannabis use. Maternal perceived stress (Perceived Stress Scale), depressive symptoms (Edinburgh Postnatal Depression Scale), and serum immune markers (IL-1β, IL-2, IL-6, IL-8, IL-10, TNFα, CRP, MMP8), were collected, although cytokine data were only available for 122 women.

Pilot Tobacco Treatment Intervention for Women in Residential Treatment for Substance Use Disorder.

Objective: To test the feasibility, acceptability, and efficacy of Get Fit and Quit (GFAQ), a community-engaged, holistic tobacco treatment program for women of childbearing age in a residential substance use disorder treatment facility.

Design: A quasi-experimental, one-group, longitudinal design.

Setting: A local Young Men's Christian Association (YMCA) location.

Comparison of Serum and Cervical Cytokine Levels throughout Pregnancy between Preterm and Term Births.

 To assess differences in cytokine levels in cervicovaginal fluid (CVF) and serum across trimesters between women with preterm births (PTBs) and full-term births.  This multicenter study enrolled 302 women with a singleton gestation. CVF and serum cytokines, interleukin 1α (IL-1α), IL-1β, IL-6, IL-8, IL-10, C-reactive protein (CRP), tumor necrosis factor (TNF)-α, and matrix metalloproteinase (MMP)-8, were measured.

Electronic cigarette liquid and device parameters and aerosol characteristics: A survey of regular users.

Introduction: Electronic cigarettes are widely variable devices, typically with user definable liquid and device parameters. Yet, little is known about how regular users manipulate these parameters. There is also limited understanding of what factors drive electronic cigarette use and liquid purchasing, and whether two common ingredients, propylene glycol and vegetable glycerin, alter the subjective effects of these devices.

Patterns of Systemic and Cervicovaginal Fluid Inflammatory Cytokines throughout Pregnancy.

Objective:  This study describes the normal variations in serum and cervicovaginal fluid (CVF) cytokine levels throughout pregnancy.

Study Design:  This multicenter, prospective study examined trimester-specific maternal serum and CVF cytokines (interleukin [IL]-1α, IL-1β, IL-6, IL-8, IL-10, tumor necrosis factor-α, and C-reactive protein [CRP]). A two-factor linear mixed modeling approach compared cytokine distribution, while pairwise comparisons evaluated differences over time.

Perceptions and use of electronic cigarettes in pregnancy.

Use of electronic cigarettes (e-cigs) is quickly growing in the United States, despite the unknown health implications and unregulated device contents. Although research is emerging around e-cigs in general, there continues to be a lack of scientific evidence regarding the safety and risks of e-cig use on maternal and fetal health, even though adverse health effects of nicotine on maternal and fetal outcomes are documented. This review summarizes existing perceptions of e-cig use in pregnancy, based on the limited number of publications available, and highlights the necessity of conducting additional research in this field of public health.