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. It is widely known clinical research will continue to become increasingly more complex for clinician scientists. This manuscript explores adoption of a clinical research competency-based job classification framework from the Joint Task Force for Clinical Trial Competency (JTFCTC) across several AMCs and the role of Human Resources (HR) in facilitating this process. This collaboration focuses on fostering successful projects tied to the business case in order to address equity and improve support for the clinical research enterprise.

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. Moreover, this study hypothesized that pregnant persons living in counties with comprehensive municipal smoke-free laws prohibiting smoking inside all workplaces and enclosed public places would exhibit a lower likelihood of preterm birth than those living in counties with weak or moderate laws (ie, smoke-free laws with exemptions that do not cover all workplaces and enclosed public places) or no smoke-free law. STUDY DESIGN: Using live birth data from the Kentucky Office of Vital Statistics with birth years ranging from 2004 to 2020, a total of 894,372 live births were recorded that indicated that a childbearing person was between the ages of 18 and 49 years and a resident of Kentucky; these live births formed the sample for the study. Municipal ordinances implemented during a given calendar year were coded in the model as present starting with the following calendar year, as the birth records were time deidentified except for the year of birth. This lagged law convention maximized the likelihood that pregnant persons included in the study were exposed to the smoke-free policy for at least a portion of their pregnancy. Multilevel logistic regression was used to assess the effect of smoke-free ordinances on the likelihood of preterm birth, with personal- and county-level variables included as potential covariates and pregnant persons nested within the county of residence. Data analysis was conducted using SAS (version 9.4; SAS Institute, Cary, NC), with an alpha level of .05. RESULTS: Nearly all personal-level variables were associated with preterm birth status. Personal factors associated with an increased likelihood of preterm birth included being older (relative to 18-24 years old; odds ratios [95% confidence intervals]: 1.02 [1.01-1.04] and 1.27 [1.24-1.31] for ages 25-34 and 35-49 years, respectively); having a history of preterm birth (odds ratio, 4.65; 95% confidence interval, 4.53-4.78); and smoking before pregnancy (odds ratio, 1.14; 95% confidence interval, 1.12-1.16). Pregnant persons living in counties with comprehensive laws were 9% less likely to have a preterm birth than those living in counties without a smoke-free ordinance (odds ratio, 0.91; 95% confidence interval, 0.89-0.94; P<.001). There was no difference in the likelihood of preterm birth between those living in counties with moderate or weak laws and those unprotected by any smoke-free ordinance in their county of residence. CONCLUSION: This study demonstrated that comprehensive municipal smoke-free laws are associated with reduced risk of preterm birth and that moderate or weak smoke-free laws are not. The findings have major implications for public health policy and underscore the potential influence of healthcare providers' advocacy for strong smoke-free policies, prohibiting smoking in all workplaces (including restaurants, bars, and casinos), to support healthy pregnancies.

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. MEASUREMENT: Variables of interest included ever use, regular use and age of initiation (first-time use) of nicotine (including tobacco) and/or cannabis and selected demographic factors. RESULTS: Ever-use of nicotine was associated with a 13-fold increase in the likelihood of having ever used cannabis. Among those who reported cannabis use, 96.4% had also used nicotine. While initiation in adolescence was most common, 27.1% of those who use nicotine and 34.9% of those who use cannabis initiated during emerging adulthood. Among regular users of nicotine, 41.5% began regular use in emerging adulthood. CONCLUSIONS: These findings underscore the continued susceptibility of emerging adults to initiation of these substances. Co-use of nicotine and cannabis is an understudied phenomenon in emerging adults with significant potential to cause harm and should be a public health priority.

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. Studies have shown adult ENDS users significantly alter use behaviors over time (switch to conventional cigarettes-only or dual use) thus complicating efforts to examine health effects of ENDS use. The purpose of this study was to describe switching behaviors and associated birth outcomes among infants of women using conventional cigarettes only, ENDS-only, or both. METHODS: This was a multisite, longitudinal study of biologically confirmed perinatal tobacco users, with nicotine product use assessed each trimester. For the purpose of analysis, participants were defined as switchers, no-switchers, or quitters. Birth outcomes were abstracted from electronic medical records. Analysis included descriptive statistics, linear and multivariate logistic regression adjusted for age, preterm birth, smoking behavior in the first trimester, and an interaction between smoking switching behavior and smoking behavior in the first trimester. Analysis was conducted using SAS v9.4 with significance determined as p < 0.05. RESULTS: At enrollment, 48.6% of participants used only conventional cigarettes, 41.7% were dual users, and 10% used ENDS-only. While almost two-thirds of participants used the same tobacco product throughout pregnancy, 26% reported switching behaviors that were complex and not easily clustered. No differences were found in birth outcomes between switchers and no-switchers; however, a difference emerged in birth weight between no-switchers and quitters. DISCUSSION: Given the limited data on health effects of ENDS use, and the known harmful consequences of perinatal nicotine use, capturing and classifying product switching behaviors is imperative to inform public health, and remains a challenge requiring further research.

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. In 2018, our team received a National Institute on Drug Abuse (NIDA) funded R34 to conduct a three year-randomized trial to test the feasibility of a novel tobacco intervention for pregnant women receiving MOUD. AIMS: The aims of this study are: (1) to determine the impact of the B-EPIC intervention on maternal tobacco use and stage of change; (2) to determine the impact of B-EPIC on tobacco-related maternal and infant health outcomes including gestational age at birth, birthweight, NAS diagnosis and severity, and number of ear and respiratory infections during the first six months; (3) to compare healthcare utilization and costs incurred by pregnant patients that receive the B-EPIC intervention versus TAU. METHODS: We plan to enroll 100 pregnant women on MOUD for this randomized controlled trial (B-EPIC intervention n = 50 and treatment as usual n = 50). A major strength of this study is its wide range of health and economic outcomes assessed on mother, neonate and the infant. CONCLUSIONS: Despite the very high rates of smoking among pregnant women with OUD, there are few tobacco treatment interventions that have been tailored for this high - risk population. The overall goal of this study is to move towards a tobacco treatment standard for pregnant women receiving treatment for OUD.

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. METHODS: Cross-sectional data from a larger study of pregnant conventional-only and dual users were analyzed. A brief survey measured perceptions of prenatal e-cigarette use and smoking behaviors. Analysis included descriptive statistics, bivariate analysis, and logistic and linear regression analysis. RESULTS: Among 176 pregnant smokers (38% dual users), more than one-half of participants believed e-cigarettes were harmful to women (56%) and posed harm to the fetus (53%). Among dual users, 41% used their e-cigarette daily, on average eight times per day. Eleven percent of dual users smoked a pack of cigarettes per day, compared with 5% of conventional-only smokers, and dual users scored significantly higher (p = .026) on the Penn State Cigarette Dependence Index. The most common e-cigarette liquid flavor was fruit (64%), and the most frequently reported e-cigarette nicotine concentration was 1-6 mg. CONCLUSIONS: Characterizing perceptions and behaviors of e-cigarette use during pregnancy is foundational for future research to explore the association between product use and maternal and infant outcomes.

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. Data analysis included chi-square tests and multivariable logistic and linear regression. All ENDS users reported JUUL as their primary product. ENDS users were more likely to be younger, use cigarettes and marijuana, and report a persistent cough. Controlling for cigarette and marijuana use, there was a trend toward greater likelihood of persistent cough among ENDS users. Compared with nonusers, salivary IL-2 and INFγ were elevated and IL-4 was decreased, controlling for cigarette and marijuana use. There was a trend toward lower IL-12p70 values among ENDS users with these covariates. Findings reveal dysregulation of salivary immune profiles toward a TH1 phenotype in emerging adult ENDS users and short-term immune function may be dysregulated in young adult e-cigarette 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. Other epidemiological data show that women of reproductive age and some pregnant women are also using ECIGs. The goal of this article is to provide readers with background information about ECIGs, with a focus on recent findings about ECIG use in pregnancy and potential implications. Among pregnant women, correlates of ECIG use include current cigarette smoking, among other factors. Regarding pregnant women's perceptions of ECIG use in pregnancy, two themes emerge from the literature: many pregnant women perceive ECIGs to be safer than conventional cigarettes, and that ECIGs can aid with smoking cessation. In contrast to these perceptions, there is little concrete evidence that ECIGs help smokers quit. In addition, there are concerns about ECIG nicotine and other toxicant delivery. Nicotine is a toxicant of particular concern for pregnant women, as nicotine is known to harm a developing fetus. There are many limitations to existing research, and the literature is scant in this area. Further, new "pod mod"-style ECIGs such as JUUL present new challenges. Overall, with limited evidence of their effectiveness, and concerns about developmental toxicology, the authors do not recommend that pregnant women use ECIGs.

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-1ß, IL-2, IL-6, IL-8, IL-10, TNFα, CRP, MMP8), were collected, although cytokine data were only available for 122 women. RESULTS: Participant average age was 29.1 years, approximately half had a high school education or less, and half were unemployed. Compared to tobacco only users, co-users were more likely to be non-White, younger and more economically disadvantaged. In the adjusted linear regression models, TNF-α levels were significantly lower among co-users relative to tobacco only users, after adjusting for age, race/ethnicity, body mass index and tobacco use group (tobacco cigarettes, electronic nicotine delivery devices [ENDS] or both). TNF-α was the only immune marker found to be significant in this analysis. Measured stress levels (M = 5.9, SD = 3.3; potential range 0-16) and depression scores (M = 7.8, SD = 5.8; potential range 0-30) were low across all participants and did not differ as a function of co-use. CONCLUSION: Preliminary results suggest women co-using during the first trimester exhibit decreased pro-inflammatory immune responsivity on one out of eight markers. Further research is needed to determine the impact of this immune modulation on fetal health outcomes and the unique contribution of cannabis.

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. PARTICIPANTS: Twenty-three women of childbearing age were enrolled in the study. Nearly all (21/23) participants were White, and most were nonpartnered and unemployed. More than one third of participants had more than high school educations, and five (22%) were pregnant at enrollment. METHODS: The program was conducted in 10 sessions over 6 months. For each 90-minute session, approximately 45 minutes were dedicated to smoking cessation, and 45 minutes were dedicated to group physical activity. Means and 95% confidence intervals were used to summarize nicotine dependence, expired carbon monoxide, urine cotinine, and exercise self-efficacy at baseline and 5-week, 8-week, and 6-month assessments. Cigarettes smoked per day were summarized using medians and interquartile ranges over time. Program satisfaction and regular exercise were presented as percentages with 95% confidence intervals. RESULTS: Of the 23 women who enrolled in GFAQ, 7 (30%) completed the program. Compared with baseline results, participants who completed GFAQ had lower nicotine dependence and smoked fewer cigarettes per day. Additionally, at 5 weeks, more GFAQ participants exercised regularly (64%) compared with baseline (14%). Most participants viewed the program favorably. CONCLUSION: Smoking in women of childbearing age with substance use disorders is an important public health issue. GFAQ is a promising intervention for tobacco treatment for this high-risk population, although the number of initial participants who completed the program was low.

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

Objective To assess differences in cytokine levels in cervicovaginal fluid (CVF) and serum across trimesters between women with preterm births (PTBs) and full-term births. Study Design This multicenter study enrolled 302 women with a singleton gestation. CVF and serum cytokines, interleukin 1α (IL-1α), IL-1ß, IL-6, IL-8, IL-10, C-reactive protein (CRP), tumor necrosis factor (TNF)-α, and matrix metalloproteinase (MMP)-8, were measured. Women with at least one cytokine assessment and noted PTB status in their medical record were retained in the study ( N = 272). Data were analyzed using mixed modeling (main effects of PTBs and time/trimester). Results For the CVF values of IL-6, IL-8, IL-10, TNF-α, and CRP, and serum MMP-8, those who delivered preterm had significantly higher values than the full-term group regardless of trimester. For the serum values of IL-1ß, IL-6, and TNF-α, those delivering preterm had significantly lower values than those delivering full-term regardless of trimester. For IL-1ß in CVF, the cytokine was significantly higher in the PTB group for second and third trimesters only, relative to the full-term group. Conclusion For each CVF cytokine that differed by birth status, values were higher for PTB than term, averaged over trimester. Numerous cytokine profiles varied across trimesters in women delivering term versus preterm in both CVF and serum.

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. METHODS: During the spring of 2016 522 adults, who reported daily use of electronic cigarettes containing nicotine, completed a survey on electronic cigarettes. Survey questions included an electronic cigarette dependence questionnaire, questions on tobacco and electronic cigarette use, and device and liquid preferences. RESULTS: Fifty-nine percent of respondents reported using another tobacco product, which was positively associated with level of nicotine dependence. On average, devices were set to 28.3 (SD = 24.2) watts. Ability to change device voltage, and level of resistance typically used, was significantly associated with level of nicotine dependence. Amount of liquid consumed, nicotine concentration, and milligrams of nicotine used per week, were positively associated with nicotine dependence. Participants rated 'good taste' as the most important consideration when using and purchasing liquids, and propylene glycol is associated with undesirable effects and vegetable glycerin with desirable effects. CONCLUSIONS: These data indicate that electronic cigarette users utilize a wide range device parameter settings and liquid variables, and that individuals with greater nicotine dependence favor voltage control devices, and lower resistance heating elements. Taste is a key factor for electronic cigarette selection, and concentrations of propylene glycol and vegetable glycerin may have a significant impact on the reinforcing effects of liquids.

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-1ß, 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. RESULTS: Trimester-specific serum cytokine data were available for 288, 243, and 221 patients, whereas CVF cytokine data were available for 273, 229, and 198 patients. CVF had significantly higher concentrations of IL-1α, IL-1ß, IL-6, IL-8, and matrix metalloproteinase-8 (p < 0.001), irrespective of the trimester. At all time points, IL-10 and CRP concentrations were higher in serum than CVF (p < 0.001). Serum IL-10 increased significantly throughout pregnancy (p < 0.001). CONCLUSION: Differences in cytokine distribution across different biological fluids are evident throughout pregnancy. These findings provide a framework for examining patterns of changes in cytokines throughout pregnancy.

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. Authors conducted a literature search of scientific peer-reviewed articles published from January 2006 to October 2016, comprising more than a decade of research. Search keywords include 'tobacco use', 'electronic cigarette(s)' and 'pregnancy'. Fifty-seven publications were identified, narrowed to fifteen by screening title/abstract for potential relevance, with seven articles chosen for final inclusion. Of these seven studies, most participants not only believed e-cigs pose risks to maternal and child health but also perceived e-cigs as a safer and potentially healthier alternative to traditional cigarettes, and may assist with smoking cessation. Further research is needed to determine health implications and provide clinical guidelines for e-cig use in pregnancy.