Urinary anatalline and nicotelline cut-points to distinguish between exclusive and dual use of tobacco products.

OBJECTIVE: This study measured anatalline and nicotelline, two minor tobacco alkaloids, to discriminate between exclusive smokeless tobacco (SLT) use, exclusive electronic nicotine delivery systems (ENDS) use, exclusive cigarette use, dual SLT and cigarette use, and dual ENDS and cigarette use. METHODS: N = 664 urine samples from participants in the Population Assessment of Tobacco and Health Study were analyzed for anatalline and nicotelline. Geometric means and 95% confidence intervals were calculated for biomarker levels and their ratios. Non-parametric Receiver Operating Characteristic analyses were used to determine optimal cut-points of natural log-transformed biomarker ratios for distinguishing between tobacco use groups. RESULTS: The anatalline/nicotelline ratio distinguished exclusive cigarette from exclusive SLT use (threshold = 18.1, sensitivity = 89.3%, specificity = 86.4%, AUC = 0.90), and exclusive SLT from exclusive ENDS use (threshold = 12.8, sensitivity = 96.4%, specificity = 76.3%, AUC = 0.90) very well, but had reduced sensitivity and specificity when distinguishing exclusive cigarette from exclusive ENDS or any dual use with cigarettes. CONCLUSIONS: This research fills a gap in understanding the public health consequences of SLT and ENDS use by providing objective measures that can signal use of these products alone or in combination with cigarettes.

Divergence in Cigarette Discontinuation Rates by Use of Electronic Nicotine Delivery Systems (ENDS): Longitudinal Findings From the United States PATH Study Waves 1-6.

INTRODUCTION: We compare real-world trends in population-level cigarette discontinuation rates among adults (ages ≥21) who smoked cigarettes, by electronic nicotine delivery systems (ENDS) use. AIMS AND METHODS: U.S nationally representative data from adults in the Population Assessment of Tobacco and Health (PATH) Study (2013/14-2021, Waves 1-6) who smoked cigarettes in the past 30 days (P30D) were analyzed (n = 13 640). The exposure was P30D ENDS use. The outcome was P30D cigarette discontinuation at biennial follow-up. Weighted trend analyses were conducted to test for differences in cigarette discontinuation trends by ENDS use. RESULTS: Between 2013/14 and 2015/16, cigarette discontinuation rates were both 16% for those who used ENDS and for those who did not; between 2018/19 and 2021, rates were ~30% for those who used ENDS and ~20% for those who did not; the time by ENDS use interaction was significant. CONCLUSIONS: The relationship between adults' ENDS use and cigarette discontinuation in the context of an expanded ENDS marketplace, new tobacco regulatory actions, and COVID-19 differs from the relationship in earlier years. IMPLICATIONS: It is important for public health decisions to be informed by research based on the contemporary ENDS marketplace and circumstances.

Respiratory symptoms and outcomes among cigar smokers: findings from the Population Assessment of Tobacco and Health (PATH) study waves 2-5 (2014-2019).

BACKGROUND: The mechanisms by which cigarette smoking increases the risk of respiratory disease have been studied. However, less is known about risks of respiratory symptoms and outcomes associated with smoking cigars, and risks by cigar types have not been previously explored. The aim of this study was to examine associations between cigar use, including traditional cigars, cigarillos, filtered cigars, and dual cigar and cigarette use, and functionally important respiratory symptoms (FIRS), lifetime asthma diagnosis, uncontrolled asthma, and new cases of FIRS. METHODS: Data from Waves 2-5 (2014-19) of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal study, were analyzed in two ways. For cross-sectional analysis, the analytic sample included adults 18 and older at each wave, resulting in 44,040 observations. Separately, longitudinal analyses were assessed among adults 18 and older at Wave 2, resulting in 7,930 individuals. Both analyses excluded adults with chronic obstructive pulmonary disease (COPD) or non-asthma respiratory disease. RESULTS: Current established cigarillo smokers had higher odds of having FIRS (Adjusted odds ratio (AOR): 1.72; 95% CI: 1.08, 2.74) compared to never smokers of cigarillos and cigarettes, after adjusting for covariates. Current established filtered cigar smokers had higher odds of asthma diagnosis (AOR: 1.35; 95% CI: 1.10, 1.66) while current established dual smokers of filtered cigars and cigarettes had higher odds of uncontrolled asthma (AOR: 5.13; 95% CI: 1.75, 15.02) compared to never smokers of filtered cigars or cigarettes. Both current established cigar smokers and current established dual smokers of cigarettes and cigars had higher odds of new FIRS compared to never cigar or cigarette smokers (AORs: 1.62; 95% CI: 1.02, 2.60 for exclusive cigars and 2.55; 95% CI 1.57, 4.14 for dual smokers). CONCLUSIONS: This study provides evidence that cigar smokers or dual smokers of cigars and cigarettes have greater odds of FIRS, asthma, and uncontrolled asthma and that new incidence of FIRS is higher among any cigar smokers compared to never cigar or cigarette smokers. Understanding health impacts associated with cigar use provides information for supporting policy development, as well as for designing clinical interventions focused on smoking cessation for cigars.

Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine.

BACKGROUND: MF59-adjuvanted gB subunit (gB/MF59) vaccine demonstrated approximately 50% efficacy against human cytomegalovirus (HCMV) acquisition in multiple clinical trials, suggesting that efforts to improve this vaccine design might yield a vaccine suitable for licensure. METHODS: A messenger RNA (mRNA)-based vaccine candidate encoding HCMV gB and pentameric complex (PC), mRNA-1647, is currently in late-stage efficacy trials. However, its immunogenicity has not been compared to the partially effective gB/MF59 vaccine. We assessed neutralizing and Fc-mediated immunoglobulin G (IgG) effector antibody responses induced by mRNA-1647 in both HCMV-seropositive and -seronegative vaccinees from a first-in-human clinical trial through 1 year following third vaccination using a systems serology approach. Furthermore, we compared peak anti-gB antibody responses in seronegative mRNA-1647 vaccinees to that of seronegative gB/MF59 vaccine recipients. RESULTS: mRNA-1647 vaccination elicited and boosted HCMV-specific IgG responses in seronegative and seropositive vaccinees, respectively, including neutralizing and Fc-mediated effector antibody responses. gB-specific IgG responses were lower than PC-specific IgG responses. gB-specific IgG and antibody-dependent cellular phagocytosis responses were lower than those elicited by gB/MF59. However, mRNA-1647 elicited higher neutralization and antibody-dependent cellular cytotoxicity (ADCC) responses. CONCLUSIONS: Overall, mRNA-1647 vaccination induced polyfunctional and durable HCMV-specific antibody responses, with lower gB-specific IgG responses but higher neutralization and ADCC responses compared to the gB/MF59 vaccine. CLINICAL TRIALS REGISTRATION: NCT03382405 (mRNA-1647) and NCT00133497 (gB/MF59).

Cigarette and ENDS dual use longitudinal transitions among adults in the Population Assessment of Tobacco and Health (PATH) Study, Waves 4-5 (2016-2019).

Introduction: The study assessed longitudinal transitions among adult (18 and older) past 30-day daily and non-daily dual users of cigarettes and electronic nicotine delivery systems (ENDS). Methods: Using data from Wave 4 (W4; 2016/17) and Wave 5 (W5; 2018/19) of the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal cohort study of US adults, multivariable regressions were conducted among W4 dual users of cigarettes and ENDS to examine past 30-day cigarette smoking at W5. The study also analyzed changes in frequency of past 30-day smoking and cigarettes smoked per day between W4 and W5, stratified by W4/W5 daily/non-daily ENDS use among W4 daily and non-daily cigarette smokers. Results: Among W4 dual users, those smoking daily and using ENDS non-daily had higher odds of daily cigarette smoking at W5 than daily users of both products (AOR: 2.32, 95 % CI: 1.38-3.90). W4 daily smokers who used ENDS daily at Wave 5 smoked cigarettes on fewer days at Wave 5 than W4 daily smokers who were either daily ENDS users at Wave 4 (B = -4.59; SE = 1.43, p < 0.01) or non-daily ENDS users at Wave 4 (B = -4.55; SE = 1.24, p < 0.001). Among W4 non-daily cigarette smokers, W4 non-daily ENDS users who used daily at W5 smoked cigarettes on fewer days (B = -4.04, SE = 1.82) at W5 than those who were non-daily ENDS users at W4 and W5. Conclusions: Findings highlight the importance of frequency of ENDS use in reducing cigarette smoking and could inform smoking cessation interventions among daily cigarette smokers.

Cardiovascular disease outcomes among established cigar users 40 years and older: Findings from the population assessment of tobacco and health (PATH) study, waves 1-5 (2013-2019).

This study examined associations between established cigar use and prevalence and incidence of cardiovascular diseases (CVD; congestive heart failure, stroke, or heart attack/needed bypass surgery) among U.S. adults, 40 years or older. Using Waves 1-5 (2013-2019) of the Population Assessment of Tobacco and Health (PATH) Study, incidence (Nindividuals (Nind) = 6,692; Nobservations (Nobs) = 23,738) and prevalence (Nind = 7,819; Nobs = 33,952) of CVD outcomes were examined using weighted generalized estimating equations (WGEEs) among adults who were exclusive current/former established cigar smokers (ever cigar smokers who have smoked fairly regularly), exclusive current/former established cigarette smokers (lifetime smokers of 100 or more cigarettes), dual current/former established cigarette and cigar smokers compared with never smokers of cigars or cigarettes, adjusting for covariates. The population-averaged incidence of CVD from one wave to next among exclusive current/former established cigar smokers during a six-year period based on WGEEs was low (overall average rate of 3.0 %; 95 % CI: 1.2, 7.0). Compared with never users, exclusive current/former established cigar smokers (OR = 1.67, 95 % CI: 1.11, 2.51) and exclusive current/former established cigarette smokers (OR = 2.12, 95 % CI: 1.45, 3.09) were more likely to have any CVD outcome in unadjusted analyses. When adjusted for covariates, only exclusive current/former established cigarette use was associated with CVD outcomes (AOR = 1.60, CI: 1.07, 2.40). Results suggest that exclusive established use of cigars or duration of exclusive cigar use was not associated with lifetime CVD prevalence compared with never cigar or cigarette smokers, which is important in understanding health outcomes in cigar users.

Longitudinal profiling of the intestinal microbiome in children with cystic fibrosis treated with elexacaftor-tezacaftor-ivacaftor.

The intestinal microbiome influences growth and disease progression in children with cystic fibrosis (CF). Elexacaftor-tezacaftor-ivacaftor (ELX/TEZ/IVA), the newest pharmaceutical modulator for CF, restores the function of the pathogenic mutated CF transmembrane conductance regulator (CFTR) channel. We performed a single-center longitudinal analysis of the effect of ELX/TEZ/IVA on the intestinal microbiome, intestinal inflammation, and clinical parameters in children with CF. Following ELX/TEZ/IVA, children with CF had significant improvements in body mass index and percent predicted forced expiratory volume in one second, and required fewer antibiotics for respiratory infections. Intestinal microbiome diversity increased following ELX/TEZ/IVA coupled with a decrease in the intestinal carriage of Staphylococcus aureus, the predominant respiratory pathogen in children with CF. There was a reduced abundance of microbiome-encoded antibiotic resistance genes. Microbial pathways for aerobic respiration were reduced after ELX/TEZ/IVA. The abundance of microbial acid tolerance genes was reduced, indicating microbial adaptation to increased CFTR function. In all, this study represents the first comprehensive analysis of the intestinal microbiome in children with CF receiving ELX/TEZ/IVA.IMPORTANCECystic fibrosis (CF) is an autosomal recessive disease with significant gastrointestinal symptoms in addition to pulmonary complications. Recently approved treatments for CF, CF transmembrane conductance regulator (CFTR) modulators, are anticipated to substantially improve the care of people with CF and extend their lifespans. Prior work has shown that the intestinal microbiome correlates with health outcomes in CF, particularly in children. Here, we study the intestinal microbiome of children with CF before and after the CFTR modulator, ELX/TEZ/IVA. We identify promising improvements in microbiome diversity, reduced measures of intestinal inflammation, and reduced antibiotic resistance genes. We present specific bacterial taxa and protein groups which change following ELX/TEZ/IVA. These results will inform future mechanistic studies to understand the microbial improvements associated with CFTR modulator treatment. This study demonstrates how the microbiome can change in response to a targeted medication that corrects a genetic disease.

Relationship Between Tobacco Product Use and Health-Related Quality of Life Among Individuals With COPD in Waves 1-5 (2013-2019) of the Population Assessment of Tobacco and Health Study.

Introduction: We examined the association between tobacco product use and health-related quality of life (HRQoL) among individuals with chronic obstructive pulmonary disease (COPD) in Waves 1-5 of the Population Assessment of Tobacco and Health (PATH) Study. Methods: Adults ≥40 years with an ever COPD diagnosis were included in cross-sectional (Wave 5) and longitudinal (Waves 1 to 5) analyses. Tobacco use included 13 mutually exclusive categories of past 30-day (P30D) single use and polyuse with P30D exclusive cigarette use and ≥5-year cigarette cessation as reference groups. Multivariable linear regression and generalized estimating equations (GEE) were used to examine the association between tobacco use and HRQoL as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 questionnaire. Results: Of 1670 adults, 79.4% ever used cigarettes; mean (standard error [SE]) pack years was 30.9 (1.1). In cross-sectional analysis, P30D exclusive cigarette use, and e-cigarette/cigarette dual use were associated with worse HRQoL compared to ≥5-year cigarette cessation. Compared to P30D exclusive cigarette use, never tobacco use and ≥5-year cigarette cessation were associated with better HRQoL, while e-cigarette/cigarette dual use had worse HRQoL. Longitudinally (n=686), e-cigarette/cigarette dual use was associated with worsening HRQoL compared to both reference groups. Only never tobacco use was associated with higher HRQoL over time compared to P30D exclusive cigarette use. Conclusions: E-cigarette/cigarette dual use was associated with worse HRQoL compared to ≥5-year cigarette cessation and exclusive cigarette use. Never use and ≥5-year cigarette cessation were the only categories associated with higher HRQoL compared to exclusive cigarette use. Findings highlight the importance of complete smoking cessation for individuals with COPD.

The relationship between the intestinal microbiome and body mass index in children with cystic fibrosis.

BACKGROUND: The nutritional status of children with cystic fibrosis (CF), as assessed by their body mass index percentile (BMIp), is a critical determinant of long-term health outcomes. While the intestinal microbiome plays an important role in nutrition, little is known regarding the relationship of the microbiome and BMIp in children with CF. METHODS: Pediatric patients (< 18 years old) with CF and healthy comparison patients (HCs) were enrolled in the study and stool samples obtained. BMIp was categorized as Green Zone (BMIp > 50th), Yellow Zone (BMIp 25th-49th) and Red Zone (BMIp < 25th). Intestinal microbiome assessment was performed via 16S rRNA gene sequencing; microbial richness, diversity, and differential species abundance were assessed. RESULTS: Stool samples were collected from 107 children with CF and 50 age-matched HCs. Compared to HCs, children with CF were found to have lower bacterial richness, alpha-diversity, and a different microbial composition. When evaluating them by their BMIp color zone, richness and alpha-diversity were lowest in those in the Red Zone. In addition, an unclassified amplicon sequence variant (ASV) of Blautia, a known butyrate-producing anaerobe, was of lowest abundance in children in the Red Zone. CONCLUSION: Children with CF have a dysbiotic intestinal microbiome with specific changes that accompany changes in BMIp. Longitudinal assessments of the microbiome and its metabolic activities over time are needed to better understand how improvements in the microbiome may improve nutrition and enhance long-term survival in children with CF.

Longitudinal Profiling of the Intestinal Microbiome in Children with Cystic Fibrosis Treated with Elexacaftor-Tezacaftor-Ivacaftor.

The intestinal microbiome influences growth and disease progression in children with cystic fibrosis (CF). Elexacaftor-tezacaftor-ivacaftor (ELX/TEZ/IVA), the newest pharmaceutical modulator for CF, restores function of the pathogenic mutated CFTR channel. We performed a single-center longitudinal analysis of the effect of ELX/TEZ/IVA on the intestinal microbiome, intestinal inflammation, and clinical parameters in children with CF. Following ELX/TEZ/IVA, children with CF had significant improvements in BMI, ppFEV1 and required fewer antibiotics for respiratory infections. Intestinal microbiome diversity increased following ELX/TEZ/IVA coupled with a decrease in the intestinal carriage of Staphylococcus aureus, the predominant respiratory pathogen in children with CF. There was a reduced abundance of microbiome-encoded antibiotic-resistance genes. Microbial pathways for aerobic respiration were reduced after ELX/TEZ/IVA. The abundance of microbial acid tolerance genes was reduced, indicating microbial adaptation to increased CFTR function. In all, this study represents the first comprehensive analysis of the intestinal microbiome in children with CF receiving ELX/TEZ/IVA.

Communication Interactions, Needs, and Preferences During Clinical Encounters of African American Parent-Child Dyads.

Human papillomavirus (HPV) vaccination rates remain suboptimal among African American adolescents. Although provider recommendations during clinical encounters are believed to be highly effective in increasing uptake and series completion, little has been reported about parent-child perspectives on the counseling received during these encounters. Among African American parent-child dyads, we sought to explore and compare interactions, needs, and preferences during clinical encounters by child's HPV vaccination status. We applied a qualitative, phenomenological study design to conduct semi-structured interviews with African American parent-child dyads representing children who were unvaccinated (n = 10), had initiated but not completed (n = 11), or had completed the HPV vaccine series (n = 9). Using iterative, inductive-deductive thematic analysis, five themes were generated: (1) parents' attitudes varied about the HPV vaccine but were mostly positive for vaccines in general; (2) patient-parent-provider clinical encounters from the parent perspective; (3) patient-parent-provider clinical encounters from the child perspective; (4) methods of distribution of supplemental HPV information; and (5) communication desired on HPV vaccination by parents and children. Parents stating they received a provider's recommendation increased by vaccination status (unvaccinated: 6 out of 10; initiated: 7 out of 11; completed: 9 out of 9). Most parents and children were not satisfied with provider communication on the HPV vaccine and used supplemental materials to inform decision-making. Ongoing communication on the HPV vaccine was requested even post-vaccination of the child. During clinical encounters, children and parental messaging needs are similar yet dissimilar. We offer communication strategies and messaging that can be used for African American parent-child dyads by child HPV vaccination status during a clinical encounter.

Patterns of Premium and Nonpremium Cigar Use in the United States: Findings from Wave 6 (2021) of the Population Assessment of Tobacco and Health Study.

INTRODUCTION: Understanding the characteristics of premium cigar use patterns is essential for minimizing public health harms. Typically, premium cigars are handmade, larger, more expensive, and without the characterizing flavors that are present in other cigar types: Nonpremium traditional cigars, cigarillos, and filtered cigars. AIMS AND METHODS: Self-reported brand and price data were used from Wave 6 of the Population Assessment of Tobacco and Health (PATH) Study to define and estimate premium versus nonpremium cigar use among U.S. adults, as well as to explore cigar smoking patterns, purchasing behavior, and reasons for use by cigar type. RESULTS: In 2021, 0.9% (95% CI = 0.7-1.0) of adults were premium cigar users, compared to 0.4% of nonpremium traditional cigar users (95% CI = 0.3-0.5), 1.1% of cigarillo users (95% CI = 1.0-1.2), and 0.6% filtered cigar users (95% CI = 0.5-0.7). Premium cigar users were overwhelmingly male (97.7%), and 35.8% were aged ≥55 years. The average premium cigar price/stick was $8.67, $5.50-7.00 more than other cigar types. Compared to other cigar types, significantly fewer premium cigar users had a regular brand with a flavor other than tobacco (~15% vs. 38%-53%). Though flavors remained the top reason for premium cigar use, they were less likely to endorse flavors as a reason for use than other cigar users (~40% vs. 68-74%). Premium cigar users had a lower prevalence (aRR: 0.37, 95% CI = 0.25-0.55) of dual use of cigars and cigarettes. CONCLUSIONS: Although <1% of U.S. adults use premium cigars, their use and purchasing characteristics continue to differ from other cigar types, highlighting the importance of capturing data specific to premium cigar use. IMPLICATIONS: This manuscript extends previous research from the National Academies of Science, Engineering, and Medicine report, "Premium cigars: Patterns of use, marketing, and health effects" by utilizing the most recent PATH Study data (Wave 6) to examine patterns of cigar use, including purchasing behavior and reasons for use, by cigar type (eg, premium traditional cigars, nonpremium traditional cigars, cigarillos, and filtered cigars). The findings support continued research on patterns of premium cigar use, which differ from use patterns of other cigar types.

Changes in Tobacco Dependence and Association With Onset and Progression of Use by Product Type From Waves 1 to 3 of the Population Assessment of Tobacco and Health (PATH) Study.

INTRODUCTION: This study examined trajectories of tobacco dependence (TD) in relationship to changes in tobacco product use, and explored the effects of product-specific adding, switching, or discontinued use on dependence over time. AIMS AND METHODS: Data were analyzed from the first three waves from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative, longitudinal study of adults and youth in the United States. Data included 9556 wave 1 (2013-2014) adult current established tobacco users aged 18 or older who completed all three interviews and had established use at ≥2 assessments. Mutually exclusive groups included: users of cigarettes only, e-cigarettes only, cigars only, hookah only, any smokeless only, cigarette + e-cigarette dual users, and other multiple product users. A validated 16-item scale assessed TD across product users. RESULTS: People who used e-cigarettes exclusively at wave 1 had small increases in TD through wave 3. Wave 1 multiple product users' TD decreased across waves. TD for all other wave 1 user groups remained about the same. For wave 1 cigarette only smokers, switching to another product was associated with lower levels of TD than smokers whose use stayed the same. Movement to no established use of any tobacco product was consistently associated with lower TD for all product users. CONCLUSIONS: Except for wave 1 e-cigarette only users (who experienced small increases in TD), TD among U.S. tobacco product users was stable over time, with daily users less likely to vary from baseline. IMPLICATIONS: The level of TD among most U.S. tobacco users was stable over the first three waves of the PATH Study and trends in levels of TD were predominantly unrelated to changes in patterns of continued product use. Stable levels of TD suggest a population at persistent risk of health impacts from tobacco. Wave 1 e-cigarette users experienced small increases in levels of TD over time, perhaps due to increases in quantity or frequency of their e-cigarette use or increasing efficiency of nicotine delivery over time.

Validating Wave 1 (2014) Urinary Cotinine and TNE-2 Cut-points for Differentiating Wave 4 (2017) Cigarette Use from Non-use in the United States Using Data from the PATH Study.

BACKGROUND: Sex and racial/ethnic identity-specific cut-points for validating tobacco use using Wave 1 (W1) of the Population Assessment of Tobacco and Health (PATH) Study were published in 2020. The current study establishes predictive validity of the W1 (2014) urinary cotinine and total nicotine equivalents-2 (TNE-2) cut-points on estimating Wave 4 (W4; 2017) tobacco use. METHODS: For exclusive and polytobacco cigarette use, weighted prevalence estimates based on W4 self-report alone and with exceeding the W1 cut-point were calculated to identify the percentage missed without biochemical verification. Sensitivity and specificity of W1 cut-points on W4 self-reported tobacco use status were examined. ROC curves were used to determine the optimal W4 cut-points to distinguish past 30-day users from non-users, and evaluate whether the cut-points significantly differed from W1. RESULTS: Agreement between W4 self-reported use and exceeding the W1 cut-points was high overall and when stratified by demographic subgroups (0.7%-4.4% of use was missed if relying on self-report alone). The predictive validity of using the W1 cut-points to classify exclusive cigarette and polytobacco cigarette use at W4 was high (>90% sensitivity and specificity, except among polytobacco Hispanic smokers). Cut-points derived using W4 data did not significantly differ from the W1-derived cut-points [e.g., W1 exclusive = 40.5 ng/mL cotinine (95% confidence interval, CI: 26.1-62.8), W4 exclusive = 29.9 ng/mL cotinine (95% CI: 13.5-66.4)], among most demographic subgroups. CONCLUSIONS: The W1 cut-points remain valid for biochemical verification of self-reported tobacco use in W4. IMPACT: Findings from can be used in clinical and epidemiologic studies to reduce misclassification of cigarette smoking status.

Indicators of Tobacco Dependence Among Youth: Findings From Wave 1 (2013-2014) of the Population Assessment of Tobacco and Health Study.

BACKGROUND: Prior work established a measure of tobacco dependence (TD) among adults that can be used to compare TD across different tobacco products. We extend this approach to develop a common, cross-product metric for TD among youth. METHODS: One thousand one hundred and forty-eight youth aged 12-17 who used a tobacco product in the past 30 days were identified from 13 651 youth respondents in Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study. FINDINGS: Analyses confirmed a single primary latent construct underlying responses to TD indicators for all mutually exclusive tobacco product user groups. Differential Item Functioning analyses supported the use of 8 of 10 TD indicators for comparisons across groups. With TD levels anchored at 0.0 (standard deviation [SD] = 1.0) among cigarette only (n = 265) use group, mean TD scores were more than a full SD lower for e-cigarette only (n = 150) use group (mean = -1.09; SD = 0.64). Other single product use group (cigar, hookah, pipe, or smokeless; n = 262) on average had lower TD (mean = -0.60; SD = 0.84), and the group with the use of multiple tobacco products (n = 471) experienced similar levels of TD (mean = 0.14; SD = 0.78) as the cigarette only use group. Concurrent validity was established with product use frequency among all user groups. A subset of five TD items comprised a common metric permitting comparisons between youth and adults. CONCLUSION: The PATH Study Youth Wave 1 Interview provided psychometrically valid measures of TD that enable future regulatory investigations of TD across tobacco products and comparisons between youth and adult tobacco product use group. IMPLICATIONS: A measure of tobacco dependence (TD) has been established previously among adults to compare TD across tobacco products. This study established the validity of a similar, cross-product measure of TD among youth. Findings suggest a single latent TD construct underlying this measure, concurrent validity of the scale with product use frequency across different types of tobacco users, and a subset of common items that can be used to compare TD between youth and adults who use tobacco.

Correction: Development of a Tailored Mobile Phone-Based Intervention to Facilitate Parent-Child Communication and Build Human Papillomavirus Vaccine Confidence: Formative Qualitative Study.

[This corrects the article DOI: 10.2196/43041.].

Development of a Tailored Mobile Phone-Based Intervention to Facilitate Parent-Child Communication and Build Human Papillomavirus Vaccine Confidence: Formative Qualitative Study.

BACKGROUND: Human papillomavirus (HPV) vaccine hesitancy is on the rise, and provider communication is a first-line strategy to address parental concerns. The use of the presumptive approach and motivational interviewing by providers may not be enough to influence parental decision-making owing to the providers' limited time, self-efficacy, and skills to implement these strategies. Interventions to enhance provider communication and build parental HPV vaccine confidence have been undertested. Delivering tailored patient education to parents via mobile phones before they visit the health care provider may address time constraints during clinic visits and positively affect vaccine uptake. OBJECTIVE: This study aimed to describe the development and evaluate the acceptability of a mobile phone-based, family-focused intervention guided by theory to address concerns of HPV vaccine-hesitant parents before the clinic visit, as well as explore intervention use to facilitate parent-child communication. METHODS: The health belief model and theory of reasoned action guided intervention content development. A multilevel stakeholder engagement process was used to iteratively develop the HPVVaxFacts intervention, including a community advisory board review, a review by an advisory panel comprising HPV vaccine-hesitant parents, a health communications expert review, semistructured qualitative interviews with HPV vaccine-hesitant parents (n=31) and providers (n=15), and a content expert review. Inductive thematic analysis was used to identify themes in the interview data. RESULTS: The qualitative interviews yielded 4 themes: overall views toward mobile device use for health information, acceptability of HPVVaxFacts, facilitators of HPVVaxFacts use, and barriers to HPVVaxFacts use. In parent interviews after reviewing HPVVaxFacts prototypes, almost all parents (29/31, 94%) stated they intended to have their child vaccinated. Most of the parents stated that they liked the added adolescents' corner to engage in optional parent-child communication (ie, choice to share and discuss information with their child; 27/31, 87%) and shared decision-making in some cases (8/31, 26%). After incorporating all input, the final intervention consisted of a 10-item survey to identify the top 3 concerns of parents, followed by tailored education that was mapped to each of the following concerns: evidential messages, images or graphics to enhance comprehension and address low literacy, links to credible websites, a provider video, suggested questions to ask their child's physician, and an optional adolescents' corner to educate the patient and support parent-child communication. CONCLUSIONS: The multilevel stakeholder-engaged process used to iteratively develop this novel intervention for HPV vaccine-hesitant families can be used as a model to develop future mobile health interventions. This intervention is currently being pilot-tested in preparation for a randomized controlled trial aiming to increase HPV vaccination among adolescent children of vaccine-hesitant parents in a clinic setting. Future research can adapt HPVVaxFacts for other vaccines and use in other settings (eg, health departments and pharmacies).

Associations between biomarkers of nicotine/tobacco exposure and respiratory symptoms among adults who exclusively smoke cigarettes in the U.S.: Findings from the PATH Study Waves 1-4 (2013-2017).

Significance: Determining if tobacco-related biomarkers of exposure (BOE) are associated with respiratory symptoms is an important public health tool that can be used to evaluate the potential harm of different tobacco products. Methods: Adult data from people who exclusively smoked cigarettes (N = 2,438) in Waves 1-4 (2013-2017) of the Population Assessment of Tobacco and Health Study were stacked to examine associations between baseline and follow-up within wave pairs (W1-W2, W2-W3, W3-W4). Weighted generalized estimating equation models were used to evaluate associations between biomarkers of nicotine, tobacco-specific nitrosamines, acrolein, acrylonitrile, cadmium, and lead at baseline/follow-up and respiratory symptom(s) (wheezing/whistling in the chest, wheezing during exercise, and/or dry cough in the past 12 months) at follow-up. Results: Higher acrolein metabolite (CEMA) levels at follow-up were associated with increased odds of respiratory symptoms at follow-up for people who exclusively smoked cigarettes (aOR = 1.34; 95% CI = 1.06, 1.70), including when limited to those without a diagnosed respiratory disease (aOR = 1.46; 95% CI = 1.12, 1.90) and those who smoked daily (aOR = 1.40; 95% CI = 1.06, 1.84). Higher cadmium levels at baseline (while controlling for follow-up levels) were associated with reduced odds of respiratory symptoms at follow-up (aOR = 0.80; 95% CI = 0.65, 0.98) among people who exclusively smoked cigarettes without a respiratory disease. There were no significant associations between baseline/follow-up BOE and follow-up respiratory symptoms for people who smoked cigarettes non-daily. Conclusions: This research supports measuring biomarkers of acrolein, such as CEMA, as a potential intermediate measurement for increased respiratory symptom development. Measuring these biomarkers could help alleviate the clinical burden of respiratory disease.

Development of a Kinetic ELISA and Reactive B Cell Frequency Assay to Detect Respiratory Syncytial Virus Pre-Fusion F Protein-Specific Immune Responses in Infants.

BACKGROUND: Respiratory syncytial virus (RSV) is a major cause of respiratory disease in infants, making vaccination an attractive preventive strategy. Due to earlier reports of vaccine-enhanced disease in RSV-naive children, assessing prior RSV infection is critical for determining eligibility for future infant vaccine trials. However, this is complicated by the presence of maternally transferred maternal antibodies. We sought to develop assays that measure immune responses to RSV pre-fusion (F) protein that discriminates between maternal and infant responses. METHODS: We measured RSV-specific responses in two groups of children <3 years of age; those with laboratory-confirmed RSV (RSV-infected) and those enrolled prior to their first RSV season (RSV-uninfected). Serial blood samples were obtained and recent infections with RSV and other respiratory viruses were assessed during follow-up. An RSV pre-F-specific kinetic enzyme-linked immunosorbent assay (kELISA) and an F-specific reactive B cell frequency (RBF) assay were developed. RESULTS: One hundred two young children were enrolled between July 2015 and April 2017; 74 were in the RSV-uninfected group and 28 were in the RSV-infected group. Participants were asked to provide sequential blood samples over time, but only 53 participants in the RSV-uninfected group and 22 participants in the RSV-infected groups provided multiple samples. In the RSV-infected group, most had positive kELISA and RBF during the study. In the RSV-uninfected group, two patterns emerged: declining kELISA values without reactive B cells, due to maternal transplacental antibody transfer, and persistently positive kELISA with reactive B cells, due to asymptomatic undiagnosed RSV infection. CONCLUSIONS: A kELISA targeting RSV pre-F epitopes and an RBF assay targeting RSV F-specific B cells generally allow discrimination between maternally and infant-derived antibodies.