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Background: The increasing use of targeted oral anticancer agents (OAAs) has transformed cancer treatment, yet patient adherence in real-world settings remains suboptimal. This protocol outlines a multi-phasic, hybrid effectiveness-implementation trial designed to develop, implement, and evaluate a risk-adapted, longitudinal medication adherence intervention for patients prescribed OAAs., Methods: Drawing on social cognitive theory, intervention mapping, and implementation science, the study aims to address barriers at cognitive, behavioral, and environmental levels that impact adherence. Phase 1 identifies implementation barriers and refines strategies, informed by expert input and semi-structured interviews. Phase 2 incorporates patient-centered feedback to tailor a theory-driven intervention targeting adherence barriers. In Phase 3, the intervention is piloted across diverse clinical settings to assess its effectiveness and implementation feasibility., Conclusion: This trial aims to deliver a scalable and sustainable model for adherence support, with broad implications for improving patient outcomes and integrating adherence monitoring in routine cancer care., Competing Interests: Declaration of competing interest Benyam Muluneh is a consultant for Servier and his spouse is employed by Novartis; Maurlia Upchurch is a post-doctoral fellow with GlaxoSmithKline, Emily Mackler has research funding with Astra Zeneca; William Wood has research funding with Genentech and Pfizer; Leah. Zullig has research funding with Proteus Digital Health, PhRMA Foundation and is a consultant for Novartis and Pfizer., (Copyright © 2025 Elsevier Inc. All rights reserved.)

Background: Electronic health records (EHRs) have been associated with information overload, causing providers to miss critical information, make errors, and delay care. Information overload can be especially prevalent in medical intensive care units (ICUs) where patients are often critically ill and their charts contain large amounts of data points such as vitals, test and laboratory results, medications, and notes., Objective: We propose to study the relationship between information overload and EHR use among medical ICU providers in 4 major United States medical centers. In this study, we examined 2 prominent EHR systems in the United States to generate reproducible and generalizable findings., Methods: Our study collected physiological and objective data through the use of a screen-mounted eye-tracker. We aim to characterize information overload in the EHR by examining ICU providers' decision-making and EHR usability. We also surveyed providers on their institution's EHR to better understand how they rate the system's task load and usability using the NASA (National Aeronautics and Space Administration) Task Load Index and Computer System Usability Questionnaire. Primary outcomes include the number of eye fixations during each case, the number of correct decisions, the time to complete each case, and number of screens visited. Secondary outcomes include case complexity performance, frequency of mouse clicks, and EHR task load and usability using provided surveys., Results: This EHR usability study was funded in 2021. The study was initiated in 2022 with a completion date of 2025. Data collection for this study was completed in December 2023 and data analysis is ongoing with a total of 81 provider sessions recorded., Conclusions: Our study aims to characterize information overload in the EHR among medical ICU providers. By conducting a multisite, cross-sectional usability assessment of information overload in 2 leading EHRs, we hope to reveal mechanisms that explain information overload. The insights gained from this study may lead to potential improvements in EHR usability and interface design, which could improve health care delivery and patient safety., International Registered Report Identifier (irrid): DERR1-10.2196/66127., (©Saif Khairat, Jennifer Morelli, Marcella H Boynton, Thomas Bice, Jeffrey A Gold, Shannon S Carson. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.02.2025.)

Background: The patient experience after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) remains poorly defined, resulting in heterogeneity in clinical assessments and research. We performed a qualitative study to better understand the experience of patients after IPAA for UC, with a focus on the symptoms experienced by patients and the resultant effects on quality of life (QoL)., Methods: We conducted semi-structured focus groups among patients who had undergone IPAA for UC. We invited patients with a variety of pouch-related conditions, including patients reporting normal pouch function and those with diagnosed inflammatory conditions of the pouch. We included questions on patients' experiences and symptoms after IPAA based on 4 thematic areas identified by a previously performed systematic review: bowel symptoms, activities, general issues and quality of life, and psychosocial., Results: We interviewed 15 individuals over the course of 4 focus groups. Participants described the significant impact that bowel symptoms after IPAA had on other activities including work and daily life, and their subsequent relation to QoL themes. Participants noted symptoms of frequency, urgency, and incontinence after IPAA, and many shared how these symptoms required them to change their lifestyle, particularly by altering their daily schedule or changing their diet. Nevertheless, most participants reported QoL improvement after IPAA., Conclusions: In this qualitative study evaluating the experience of patients after IPAA, multiple bowel-related symptoms impact other areas of life and overall QoL. Patients undergoing IPAA for UC represent a unique patient population, and thus patient-centered outcome measures should be designed to standardize their assessment., Competing Interests: Edward L. Barnes has served as a consultant for AbbVie, Boomerang, Pfizer, Eli Lilly, Takeda, and Target RWE. Hans H. Herfarth has served as a consultant for Alivio, AMAG, BMS, Boehringer, ExeGi Pharma, Finch, Gilead, Janssen, Lycera, Merck, Otsuka, Pfizer, PureTech, Seres and research support from Allakos, Artizan, NovoNordisk, Pfizer. Michael D. Kappelman has served as a consultant for Abbvie, Takeda, Janssen, Pfizer, and Eli Lilly and has received research support from Abbvie and Janssen. Marcella H. Boynton, Darren A. DeWalt, and Erica J. Brenner have no relevant conflicts of interests., (© The Author(s) 2025. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Background: Opinion leadership, educational outreach visiting, and innovation championing are commonly used strategies to address barriers to implementing innovations and evidence-based practices in healthcare settings. Despite voluminous research, ambiguities persist in how these strategies work and under what conditions they work well, work poorly, or work at all. The current paper develops middle-range theories to address this gap., Methods: Conceptual articles, systematic reviews, and empirical studies informed the development of causal pathway diagrams (CPDs). CPDs are visualization tools for depicting and theorizing about the causal process through which strategies operate, including the mechanisms they activate, the barriers they address, and the proximal and distal outcomes they produce. CPDs also clarify the contextual conditions (i.e., preconditions and moderators) that influence whether, and to what extent, the strategy's causal process unfolds successfully. Expert panels of implementation scientists and health professionals rated the plausibility of these preliminary CPDs and offered comments and suggestions on them., Findings: Theoretically, opinion leadership addresses potential adopters' uncertainty about likely consequences of innovation use (determinant) by promoting positive attitude formation about the innovation (mechanism), which results in an adoption decision (proximal outcome), which leads to innovation use (intermediate outcome). As this causal process repeats, penetration, or spread of innovation use, occurs (distal outcome). Educational outreach visiting addresses knowledge barriers, attitudinal barriers, and behavioral barriers (determinants) by promoting critical thinking and reflection about evidence and practice (mechanism), which results in behavioral intention (proximal outcome), behavior change (intermediate outcome), and fidelity, or guideline adherence (distal outcome). Innovation championing addresses organizational inertia, indifference, and resistance (determinants) by promoting buy-in to the vision, fostering a positive implementation climate, and increasing collective efficacy (mechanisms), which leads to participation in implementation activities (proximal outcome), initial use of the innovation with increasing skill (intermediate outcome) and, ultimately, greater penetration and fidelity (distal outcomes). Experts found the preliminary CPDs plausible or highly plausible and suggested additional mechanisms, moderators, and preconditions, which were used to amend the initial CPD., Discussion: The middle-range theories depicted in the CPDs furnish testable propositions for implementation research and offer guidance for selecting, designing, and evaluating these social influence implementation strategies in both research studies and practice settings., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Weiner, Meza, Klasnja, Lengnick-Hall, Buchanan, Lyon, Mettert, Boynton, Powell and Lewis.)

Introduction: US tobacco manufacturers can seek authorization from the US Food and Drug Administration (FDA) to market products using modified risk tobacco product (MRTP) claims. To inform regulatory decisions, we examined the impact of MRTP claim specificity and content, including whether the claims produced halo effects (ie, inferring health benefits beyond what is stated)., Aims and Methods: Participants were 3161 US adult cigarette smokers. Using a two (general vs. specific) × 2 (risk vs. exposure) plus independent control design, we randomized participants to view one message from these conditions: general risk claim (eg, "smoking-related diseases"), general exposure claim (eg, "chemicals in smoke"), specific risk claim (eg, "lung cancer"), specific exposure claim (eg, "arsenic"), or control. Claims described the benefits of completely switching from cigarettes to the heated tobacco product IQOS., Results: MRTP claims of any sort elicited a higher willingness to try IQOS relative to control (d = 0.09, p = .043). Claims also elicited lower perceived risk of disease and exposure to harmful chemicals for completely switching from cigarettes to IQOS (d = -0.32 and -0.31) and partially switching (d = -0.25 and d = -0.26; all p < .05). Relative to specific MRTP claims, general MRTP claims led to lower perceived risk and exposure for complete switching (d = -0.13 and d = -0.16) and partial switching (d = -0.14 and d = -0.12; all p < .05). Risk and exposure MRTP claims had similar effects (all p > .05)., Discussion: MRTP claims led to lower perceived risk and exposure, and higher willingness to try IQOS. General claims elicited larger effects than specific claims. MRTP claims also promoted unintended halo effects (eg, lower perceived risk of disease and chemical exposure for partial switching)., Implications: We found evidence that MRTP claims promoted health halo effects. In light of these findings, the FDA should require research on halo effects prior to authorization. Further, if an MRTP claim is authorized, FDA should require tobacco manufacturers to conduct post-market surveillance of how the claim affects consumer understanding, including partial switching perceived risk and exposure beliefs, as well as monitoring of dual-use behaviors., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Neonatal rodents undergo anesthesia for numerous procedures and for euthanasia by anesthetic overdose. However, data regarding whether neonatal anesthesia is humane are limited. Hypothermia (cryoanesthesia) is the most commonly used anesthetic protocol for neonatal rats 10 d of age or younger. However, hypothermia has recently been restricted in several countries due to perceived painful effects, including pain on rewarming. Minimizing the potential pain and distress of neonates in research is imperative, although very challenging. Traditional validated and nonvalidated behavioral and physiologic outcome measures used for adult rats undergoing anesthesia are unsuitable for evaluating neonates. Therefore, we investigated the effects of several anesthetic methods on neonatal rats by using the innovative objective approaches of noninvasive ultrasonic vocalizations and more invasive neuroendocrine responses (i. e., serum corticosterone, norepinephrine, glucose). Our results show that hypothermia leads to heightened acute distress in neonatal rats as indicated by prolonged recovery times, increased duration of vocalizations, and elevated corticosterone levels, as compared with neonates undergoing inhalational anesthesia. We demonstrate that inhalational anesthesia is preferable to cryoanesthesia for neonatal rats, and researchers using hypothermia anesthesia should consider using inhalational anesthesia as an alternative method.

Background: Routine self-monitoring of blood glucose is a low-value practice that provides limited benefit for patients with non-insulin-treated type 2 diabetes mellitus., Objectives: We estimated the costs of Rethink the Strip (RTS), a multistrategy approach to the de-implementation of self-monitoring of blood glucose in primary care., Research Design: RTS was conducted among 20 primary care clinics in North Carolina. We estimated the non-site-based and site-based costs of the 5 RTS strategies (practice facilitation, audit and feedback, provider champions, educational meetings, and educational materials) from the analytic perspective of an integrated health care system for 12 and 27-month time horizons. Material costs were tracked through project records, and personnel costs were assessed using activity-based costing. We used nationally based wage estimates., Results: Total RTS costs equaled $68,941 for 12 months. Specifically, non-site-based costs comprised $16,560. Most non-site-based costs ($11,822) were from the foundational programming and coding updates to the electronic health record data to develop the audit and feedback reports. The non-site-based costs of educational meetings, practice facilitation, and educational materials were substantially lower, ranging between ~$400 and $1000. Total 12-month site-based costs equaled $2569 for a single clinic (or $52,381 for 20 clinics). Educational meetings were the most expensive strategy, averaging $1401 per clinic. The site-based costs for the 4 other implementation strategies were markedly lower, ranging between $51 for educational materials and $555 for practice facilitation per clinic., Conclusions: This study provides detailed cost information for implementation strategies used to support evidence-based programs in primary care clinics., Competing Interests: L.P.S. has received salary support from AstraZeneca paid to her institution for unrelated work. The remaining authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: In recent years, vaping prevention campaigns have proliferated in response to a surge of e-cigarette use among adolescents in the USA. To date, the research literature has provided minimal guidance as to what vaping prevention message elements have the greatest potential for discouraging vaping, are ineffective or have unintended negative effects. The purpose of the current study was to identify and test a large set of vaping prevention ads used by federal, state, local and non-governmental agencies, examining how objectively coded message elements of vaping prevention messages might affect youth., Methods: A convenience sample of adolescents (N=1501) completed an online survey with each participant rating seven randomly selected vaping prevention ads from a pool of 220 ads on perceived message effectiveness (PME) and vaping appeal. Ads were coded on 37 objective elements in three message categories: themes, imagery and other features. Analyses examined how objective elements predicted PME., Results: Addiction, chemicals, negative health symptoms and effects, and cigarette comparison themes were associated with higher PME, as were graphic images and warning symbols. Industry targeting, environmental impact, flavour themes, images of food and people's faces were associated with lower PME, as were hashtags, statistics and first-person language or the word 'teen'. Most elements were not associated with appeal, but ads with a flavour theme were associated with increased vaping appeal., Conclusion: Promising vaping prevention messages focus on the adverse consequences of vaping, use negative imagery and avoid speaking for teens using their vernacular or perspective., Competing Interests: Competing interests: SMN has served as a paid expert witness in litigation against tobacco and e-cigarette companies., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Health departments in the United States routinely conduct quality improvement (QI) coaching to help primary care providers optimize vaccine delivery. In a prior trial focusing on multiple adolescent vaccines, this light-touch intervention yielded only short-term improvements in HPV vaccination. We sought to evaluate the impact of an enhanced, HPV vaccine-specific QI coaching intervention when delivered in person or virtually., Methods: We partnered with health departments in three states to conduct a pragmatic cluster randomized trial in 2015 to 2016. We randomized 224 primary care clinics to receive no intervention (control), in-person coaching, or virtual coaching. Health department staff delivered the brief (45-60 minute) coaching interventions, including HPV vaccine-specific training with assessment and feedback on clinics' vaccination coverage (i.e., proportion of patients vaccinated). States' immunization information systems provided data to assess coverage change for HPV vaccine initiation (≥1 doses) at 12-month follow-up, among patients ages 11 to 12 (primary outcome) and 13 to 17 (secondary outcome) at baseline., Results: Clinics served 312,227 patients ages 11 to 17. For ages 11 to 12, coverage change for HPV vaccine initiation was higher in the in-person and virtual coaching arms than in the control arm at 12-month follow-up (1.2% and 0.7% point difference, both P < 0.05). For ages 13 to 17, coverage change was higher for virtual coaching than control (1.4% point difference, P < 0.001), but in-person coaching did not yield an intervention effect., Conclusions: Our brief QI coaching intervention produced small long-term improvements in HPV vaccination., Impact: Health departments may benefit from targeting QI coaching to specific vaccines, like HPV vaccine, that need them most., (©2022 American Association for Cancer Research.)

The overdiagnosis of urinary tract infections (UTIs) in nursing home residents is a significant public health threat. Using a discrete choice experiment and a diagnostic guideline, we examined which patient-level information was associated with the overdiagnosis of UTIs and found that urinalysis results and lower urinary tract status were most associated.

Periodontitis is a chronic inflammatory disease associated with persistent oral microbial dysbiosis. The human β-glucuronidase (GUS) degrades constituents of the periodontium and is used as a biomarker for periodontitis severity. However, the human microbiome also encodes GUS enzymes, and the role of these factors in periodontal disease is poorly understood. Here, we define the 53 unique GUSs in the human oral microbiome and examine diverse GUS orthologs from periodontitis-associated pathogens. Oral bacterial GUS enzymes are more efficient polysaccharide degraders and processers of biomarker substrates than the human enzyme, particularly at pHs associated with disease progression. Using a microbial GUS-selective inhibitor, we show that GUS activity is reduced in clinical samples obtained from individuals with untreated periodontitis and that the degree of inhibition correlates with disease severity. Together, these results establish oral GUS activity as a biomarker that captures both host and microbial contributions to periodontitis, facilitating more efficient clinical monitoring and treatment paradigms for this common inflammatory disease.

Background and Aims: There is a paucity of validated measures to evaluate how patients feel and function after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis. We performed a systematic review to evaluate all published patient reported outcomes (PROs) to assess symptom burden, functional status, and quality of life (QoL) after IPAA., Methods: An electronic literature search on PubMed, Embase, and Web of Science was performed from inception through October 12, 2021. Eligible full texts were further characterized by the type of assessment as well as the individual domains assessed by questions in the PRO measure., Results: Among the 129 full texts analyzed, 51 specific PRO measures were utilized. In the evaluation of all PRO measures, 46% included an assessment of disease-specific QoL with 27% evaluating more general QoL, and 15% assessing symptoms related to pouch function. Among the studies using disease-specific instruments, the Cleveland Clinic Global Quality of Life (42%) and the Inflammatory Bowel Disease Questionnaire (21%) were the most commonly used PRO measures. PRO questions were mapped to individual domains using binning methodology, with the greatest number of questions from individual PRO measures mapped to the bowel function domain (122)., Conclusion: In our assessment of PRO measures among patients after IPAA, the studies and individual measures varied widely in both the patient populations being evaluated as well as outcomes and specific domains being assessed. A valid measure that assesses the range of outcomes after IPAA could standardize assessment and advance the study of patients after IPAA., Competing Interests: Conflicts of Interest: These authors disclose the following: Edward L. Barnes has served as a consultant for AbbVie, Bristol-Meyers Squibb, Lilly, and Target RWE. Hans H. Herfarth has served as a consultant for Alivio, AMAG, BMS, Boehringer, ExeGi Pharma, Finch, Gilead, Janssen, Lycera, Merck, Otsuka, Pfizer, PureTech, Seres and research support from Allakos, Artizan, NovoNordisk, Pfizer. Michael D. Kappelman has served as a consultant for Abbvie, Takeda, Janssen, Pfizer, and Eli Lilly and has received research support from Abbvie and Janssen. The remaining authors disclose no conflicts.

Background: There is a fundamental gap in understanding the causal mechanisms by which strategies for implementing evidence-based practices address local barriers to effective, appropriate service delivery. Until this gap is addressed, scientific knowledge and practical guidance about which implementation strategies to use in which contexts will remain elusive. This research project aims to identify plausible strategy-mechanism linkages, develop causal models for mechanism evaluation, produce measures needed to evaluate such linkages, and make these models, methods, and measures available in a user-friendly website. The specific aims are as follows: (1) build a database of strategy-mechanism linkages and associated causal pathway diagrams, (2) develop psychometrically strong, pragmatic measures of mechanisms, and (3) develop and disseminate a website of implementation mechanisms knowledge for use by diverse stakeholders., Methods: For the first aim, a combination of qualitative inquiry, expert panel methods, and causal pathway diagramming will be used to identify and confirm plausible strategy-mechanism linkages and articulate moderators, preconditions, and proximal and distal outcomes associated with those linkages. For the second aim, rapid-cycle measure development and testing methods will be employed to create reliable, valid, pragmatic measures of six mechanisms of common strategies for which no high-quality measures exist. For the third aim, we will develop a user-friendly website and searchable database that incorporates user-centered design, disseminating the final product using social marketing principles., Discussion: Once strategy-mechanism linkages are identified using this multi-method approach, implementation scientists can use the searchable database to develop tailored implementation strategies and generate more robust evidence about which strategies work best in which contexts. Moreover, practitioners will be better able to select implementation strategies to address their specific implementation problems. New horizons in implementation strategy development, optimization, evaluation, and deployment are expected to be more attainable as a result of this research, which will lead to enhanced implementation of evidence-based interventions for cancer control, and ultimately improvements in patient outcomes., (© 2022. The Author(s).)

Background and Objectives: US health departments routinely conduct in-person quality improvement (QI) coaching to strengthen primary care clinics' vaccine delivery systems, but this intervention achieves only small, inconsistent improvements in human papillomavirus (HPV) vaccination. Thus, we sought to evaluate the effectiveness of combining QI coaching with remote provider communication training to improve impact., Methods: With health departments in 3 states, we conducted a pragmatic 4-arm cluster randomized clinical trial with 267 primary care clinics (76% pediatrics). Clinics received in-person QI coaching, remote provider communication training, both interventions combined, or control. Using data from states' immunization information systems, we assessed HPV vaccination among 176 189 patients, ages 11 to 17, who were unvaccinated at baseline. Our primary outcome was the proportion of those, ages 11 to 12, who had initiated HPV vaccination at 12-month follow-up., Results: HPV vaccine initiation was 1.5% points higher in the QI coaching arm and 3.8% points higher in the combined intervention arm than in the control arm, among patients ages 11 to 12, at 12-month follow-up (both P < .001). Improvements persisted at 18-month follow-up. The combined intervention also achieved improvements for other age groups (ages 13-17) and vaccination outcomes (series completion). Remote communication training alone did not outperform the control on any outcome., Conclusions: Combining QI coaching with remote provider communication training yielded more consistent improvements in HPV vaccination uptake than QI coaching alone. Health departments and other organizations that seek to support HPV vaccine delivery may benefit from a higher intensity, multilevel intervention approach., (Copyright © 2022 by the American Academy of Pediatrics.)

This study examined whether certain patient characteristics are associated with the prescribing of self-monitoring of blood glucose for patients with type 2 diabetes who are not using insulin and have well-controlled blood glucose. Against recommendations, one-third of the patient sample from a large health network in North Carolina ( N = 9,338) received a prescription for testing supplies (i.e., strips or lancets) within the prior 18 months. Women, African Americans, individuals prescribed an oral medication, nonsmokers, and those who were underweight or normal weight all had greater odds of receiving such a prescription. These results indicate that providers may have prescribing tendencies that are potentially biased against more vulnerable patient groups and contrary to guidelines., (© 2022 by the American Diabetes Association.)

Background: Mobile health technologies can be useful for providing disease self-management information and support to people with inflammatory bowel disease (IBD)., Objective: The aim of this study was to test a self-management SMS text messaging intervention for people with IBD. Our goal was to examine intervention feasibility, acceptability, and engagement and to preliminarily evaluate improvements in certain self-reported health outcomes among participants., Methods: We developed an SMS text messaging program called Text4IBD. The program sent daily support messages and resources about disease self-management over the course of a 2-week, single-group, pretest-posttest intervention to participants (N=114) diagnosed with IBD. We examined intervention feasibility, acceptability, and engagement through Text4IBD message topic recall and use of resources (ie, visiting supplemental websites recommended by the Text4IBD program). We also assessed pretest-posttest measures of IBD-related distress, self-efficacy, perceived support, use of coping strategies, and medication adherence. Analyses examined participants' evaluations of the intervention and compared pretest-posttest changes in secondary outcomes using paired-samples statistics., Results: Approximately all participants who completed the intervention (n=105) were receptive to Text4IBD and viewed the program as feasible and acceptable. In addition, most participants (103/105, 98.1%) recalled at least one of the message topics sent by the program, and 79% (83/105) of them self-reported engaging with at least one of the external self-management resources recommended by the Text4IBD program. Pretest-posttest results showed reduced IBD-related distress (mean 3.33, SD 0.68 vs mean 2.86, SD 0.73; P<.001) and improvements in most other secondary outcomes., Conclusions: Findings from this study highlight the value of SMS text messaging as a useful digital medium for providing support to people with IBD, particularly to those who may struggle with disease-related distress. Text4IBD was highly feasible and acceptable and may help people self-manage their IBD. Future studies should aim to evaluate this program in a randomized controlled trial in clinical settings., (©Jacob A Rohde, Edwin B Fisher, Marcella H Boynton, Deen Freelon, Dennis O Frohlich, Edward L Barnes, Seth M Noar. Originally published in JMIR Formative Research (https://formative.jmir.org), 06.05.2022.)

Purpose: To inform overprescribing and antibiotic stewardship in nursing homes (NHs), we examined the concordance between clinicians' (NH primary care providers and registered nurses) diagnosis of suspected UTI with a clinical guideline treated as the gold standard, and whether clinician characteristics were associated with diagnostic classification., Methods: We conducted a cross-sectional web-based survey of a U.S. national convenience sample of NH clinicians. The survey included a discrete choice experiment with 19 randomly selected clinical scenarios of NH residents with possible UTIs. For each scenario, participants were asked if they thought a UTI was likely. Responses were compared to the guideline to determine the sensitivity and specificity of clinician judgment and performance indicators. Multivariable logistic mixed effects regression analysis of demographic, work, personality, and UTI knowledge/attitudes characteristics was conducted., Results: One thousand seven hundred forty-eight NH clinicians responded to 33,212 discrete choice scenarios; 867 (50%) were NH primary care providers and 881 (50%) were NH registered nurses, 39% were male, and the mean age was 45 years. Participants were uncertain about diagnosis in 30% of scenarios. Correct classification occurred for 66% of all scenarios (providers: 70%; nurses: 62%). Respondent judgment had a sensitivity of 78% (providers: 81%; nurses: 74%) and specificity of 54% (providers: 59%; nurses: 49%) compared to the clinical guideline. Adjusting for covariates in multivariable models, being a nurse and having higher closemindedness were associated higher odds of false positive UTI (odds ratio [OR] 1.61, p < 0.001; and OR 1.09, p = 0.039, respectively), although higher UTI knowledge and conscientiousness were associated with lower odds of false positive UTI ratings (OR 0.80, p < 0.001; OR 0.90, p = 0.005, respectively)., Conclusions: Clinicians tend to over-diagnose urinary tract infections, necessitating systems-based interventions to augment clinical decision-making. Clinician type, UTI knowledge, and personality traits may also influence behavior and deserve further study., (© 2022 The American Geriatrics Society.)

Rationale: Historic and present-day racism and inequity in the United States (U.S.) have resulted in diminished trust in health care among many populations. A key barrier to improving trust in health care is a dearth of well-validated measures appropriate for diverse populations. Indeed, systematic reviews indicate a need to develop and test updated trust measures that are multidimensional and inclusive of relevant domains (e.g., fairness)., Objective: We developed three trust measures: the Trust in My Doctor (T-MD), Trust in Doctors in General (T-DiG), and Trust in the Health Care Team (T-HCT) scales., Methods: After developing an initial item pool, expert reviewers (n = 6) provided feedback on the face validity of each scale. We conducted cognitive interviews (n = 21) with a convenience sample of adults to ensure items were interpreted as intended. In 2020, we administered an online survey to a convenience sample of U.S. adults recruited through the Qualtrics Panel (n = 801) to assess scale reliability and validity., Results: Exploratory and confirmatory factor analyses indicated acceptable model fit for second order latent factor models for each scale (root mean square error of approximation: <0.07, comparative fit index: ≥0.98, and standardized root mean square residual: ≤0.03). The T-MD contained 25 items and six subscales: communication competency, fidelity, systems trust, confidentiality, fairness, and global trust. The T-DiG and T-HCT each contained 29 items and seven subscales (the same subscales in the T-MD plus an additional subscale related to stigma-based discrimination). Each scale was strongly correlated with existing trust measures and perceived racism in health care and was significantly associated with delayed health care seeking and receipt of a routine health exam., Conclusions: The multidimensional T-MD, T-DiG, and T-HCT scales have sound psychometric properties and may be useful for researchers evaluating trust-related interventions or conducting studies where trust is an important construct or main outcome., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: From a public health perspective, electronic nicotine delivery devices (ENDS) use may be beneficial for some populations (e.g., smokers who fully switch to ENDS) but detrimental for others (e.g., nonsmokers). Understanding the importance placed on different ENDS product features by user groups can guide interventions and regulations., Methods: Participants were US adults who had used ENDS at least once and from a convenience sample drawn from a market research software in 2016. Participants chose between 9 different ENDS product features (harms of use, general effects of use, use as a cessation aid, initial purchase price, monthly cost, nicotine content, flavor availability, device design, and modifiability). A latent class analysis (LCA) identified subgroups of feature preferences and examined differences between groups by socio-demographics and tobacco product use., Results: Of the 636 participants, 81% were White, the median age was 42, and 65% were current cigarette smokers. The LCA identified a 4-class solution as the most appropriate model: (1) people with high nicotine dependence who preferred ENDS similar to combustible cigarettes, (2) people with moderate tobacco use who were interested in low nicotine ENDS (3) people who use ENDS and combustible tobacco who preferred lower price and flavored ENDS products, and (4) people who used ENDS predominantly, without a strong preference for any of the features presented., Conclusions: Tobacco use classes were associated with differences in preferences for ENDS features. These findings can inform regulations to reduce ENDS use among specific groups of people who use ENDS products., (© 2022. The Author(s).)

Objectives: To identify risk factors associated with mortality for infants receiving dialysis in the neonatal intensive care unit (NICU)., Study Design: In this retrospective cohort study, we extracted data from the Pediatrix Clinical Data Warehouse on all infants who received dialysis in the NICU from 1999 to 2018. Using a Cox proportional hazards model with robust SEs we estimated the mortality hazard ratios associated with demographics, birth details, medical complications, and treatment exposures., Results: We identified 273 infants who received dialysis. Median gestational age at birth was 35 weeks (interquartile values 33-37), median birth weight was 2570 g (2000-3084), 8% were small for gestational age, 41% white, and 72% male. Over one-half of the infants (59%) had a kidney anomaly; 71 (26%) infants died before NICU hospital discharge. Factors associated with increased risk of dying after dialysis initiation included lack of kidney anomalies, Black race, gestational age of <32 weeks, necrotizing enterocolitis, dialysis within 7 days of life, and receipt of paralytics or vasopressors (all P < .05)., Conclusion: In this cohort of infants who received dialysis in the NICU over 2 decades, more than 70% of infants survived. The probability of death was greater among infants without a history of a kidney anomaly and those with risk factors consistent with greater severity of illness at dialysis initiation., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Parents often decline HPV vaccination, but little is known about how healthcare providers should promote vaccination at a later visit for secondary acceptance. We examined the associations of two factors, providers' response to declination during the visit and follow-up after the visit, with secondary acceptance., Methods: We conducted a cross-sectional survey of US parents whose 9- to 17-year-old child had not yet completed the HPV vaccination series. Parents who declined HPV vaccination during an initial discussion with a provider (n = 447) reported whether their provider engaged in any active response during the visit (e.g., giving information, trying to change their mind) or any follow-up after the visit (e.g., scheduling another visit). We conducted multivariable logistic regression to determine whether an active response or follow-up was associated with secondary acceptance of HPV vaccination., Results: Only about one-third of parents reported an active response during the visit (35%) or follow-up after the visit (39%) following HPV vaccination declination. Parents had higher odds of secondary acceptance of HPV vaccine if they received any provider follow-up after the visit (43% vs. 20%, aOR:3.19; 95% CI:2.00:5.07). Receipt of an active provider response was not associated with secondary acceptance. More parents thought a provider should actively respond and follow-up (61% and 68% respectively), compared with those who received such a response (both p < .01)., Conclusions: Providers' follow-up after the visit may be important for promoting secondary acceptance of HPV vaccination. Parents who decline HPV vaccination often prefer to receive an active response or follow-up from a provider., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Although not in the past three years, we do wish to share that Dr. Brewer has received vaccine-related grants and honoraria from or served on paid advisory boards for Merck Sharp & Dohme Corp, Pfizer and GlaxoSmithKline., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Introduction: Federal, state, local, and non-government officials have developed and implemented a variety of vaping prevention messages to curtail the vaping epidemic among youth in the US. This study sought to collect a comprehensive set of vaping prevention messages and characterize the themes and features of those messages., Methods: We used a two-fold search strategy to identify messages, utilizing the existing content database from Vaping Prevention Resource (vapingprevention.org) and supplementing those messages with web searches. Potential messages were included if they were vaping prevention-oriented, appropriate or relevant for youth, and in a static web or print format., Results: A total of 220 messages met criteria. Messages were coded on the presence or absence of 37 objective features within five categories: message themes, imagery, text features, message perspective, and other (e.g., source). The most common themes were nicotine addiction (32%), chemicals (30%), health effects (24%), and industry targeting (19%). Eighty-five percent of messages included imagery, with 27% showing a vaping device, 22% showing smoke or vapor, and 21% showing a person's face. Just over half (56%) included a message source., Conclusions: Vaping prevention messages for youth have commonly focused on addiction and health risks of vaping, and they vary on a series of text and image features. Further research is needed to understand the efficacy of messaging approaches in preventing vaping among youth., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: SMN has served as a paid expert witness in litigation against tobacco and e-cigarette companies., (© 2021 Published by Elsevier Ltd.)

Background: Unhealthy alcohol use is a leading cause of preventable deaths in the USA and is associated with many societal and health problems. Less than a third of people who visit primary care providers in the USA are asked about or ever discuss alcohol use with a health professional., Methods/design: This study is an adaptive, randomized, controlled trial to evaluate the effect of primary care practice facilitation and telehealth services on evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use in small-to-medium-sized primary care practices. Study participants will include primary care practices in North Carolina with 10 or fewer providers. All enrolled practices will receive a practice facilitation intervention that includes quality improvement (QI) coaching, electronic health record (EHR) support, training, and expert consultation. After 6 months, practices in the lower 50th percentile (based on performance) will be randomized to continued practice facilitation or provision of telehealth services plus ongoing facilitation for the next 6 months. Practices in the upper 50th percentile after the initial 6 months of intervention will continue to receive practice facilitation alone. The main outcome measures include the number (and %) of patients in the target population who are screened for unhealthy alcohol use, screen positive, and receive brief counseling. Additional measures include the number (and %) of patients who receive pharmacotherapy for AUD or are referred for AUD services. Sample size calculations determined that 35 practices are needed to detect a 10% increase in the main outcome (percent screened for unhealthy alcohol use) over 6 months., Discussion: A successful intervention would significantly reduce morbidity among adults from unhealthy alcohol use by increasing counseling and other treatment opportunities. The study will produce important evidence about the effect of practice facilitation on uptake of evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use when delivered on a large scale to small and medium-sized practices. It will also generate scientific knowledge about whether embedded telehealth services can improve the use of evidence-based screening and interventions for practices with slower uptake. The results of this rigorously conducted evaluation are expected to have a positive impact by accelerating the dissemination and implementation of evidence related to unhealthy alcohol use into primary care practices., Trial Registration: ClinicalTrials.gov NCT04317989 . Registered on March 23, 2020., (© 2021. The Author(s).)

Sexual empowerment represents an important HIV intervention strategy, yet limited attention has examined the multidimensional nature of sexual empowerment in prior studies. Using a sample (n = 465) of young Black men who have sex with men (MSM), we used confirmatory factor analysis (CFA) to test a multifactorial operationalization of sexual empowerment. CFA indicated that a bifactor model was best suited to characterize the sexual empowerment factor (SEF), suggesting that items for four sub-constructs (self-efficacy to refuse sexual behavior, emotional support, condom use self-efficacy, and social norms on condom use) contributed to their respective constructs, while also contributing to a latent sexual empowerment construct. We then examined the association between SEF and mental health outcomes (anxiety and depression symptoms) and safer sex intentions. SEF was negatively associated with mental health outcomes and positively associated with safer sex intentions. Ultimately, individuals with greater sexual empowerment might be better equipped to develop strategies to buffer their vulnerability to HIV. We discuss the implications of SEF as a bifactor during the design and evaluation of HIV risk-reduction interventions seeking to address sexual empowerment among MSM.

Sexual empowerment is a key strategy in HIV prevention intervention design, yet its measurement has been conceptualized as homogeneous. To date, no studies have examined whether young Black men who have sex with men (YBMSM) exhibit heterogeneity across sexual empowerment. Using baseline data from a randomized controlled trial (N = 275, HIV-negative YBMSM), we classified YBMSM into sexual empowerment profiles based on five indicators using a latent profile analysis and assessed the associations between the sexual empowerment profiles and stigma-related experiences using multinomial logistic regression. Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3). YBMSM reporting fewer stigma-related experiences were more likely to be profile 1 than profile 2 and profile 3. To empower YBMSM, interventions based on sexual empowerment profile targeting the psychological/behavioral aspects of empowerment and addressing stigma are needed.

Perceptions of the importance of health problems can drive advocacy, policy change, resource distribution, and individual behaviors. However, little is known about how lesbian, gay, bisexual, and transgender (LGBT), that is, sexual and gender minority (SGM) adults view the health problems facing SGM populations. In a 2017 national, probability-based survey of U.S. SGM adults ( N = 453), we asked respondents to identify the most serious health problem facing SGM people today. Participants also rated the seriousness of five specific health problems (HIV/AIDS, suicide, hate crimes, harmful alcohol use, tobacco use). Analyses accounted for the complex sampling design and were stratified by gender identity. One quarter of U.S. SGM adults identified the most serious health problem facing SGM people to be HIV/AIDS (95% confidence interval [20.3, 31.2]). More respondents stated there were no serious LGBT health differences compared with straight/cisgender adults (4.2%, confidence interval [2.6, 5.9]) than identified tobacco use, hate crimes, chronic diseases, cancer, or suicide as the most serious. Importance ratings differed by gender and tobacco/alcohol use were perceived as less serious compared with HIV/AIDS, suicide, and hate crimes. Attention paid to HIV/AIDS by the SGM public, while important, may hinder efforts to address chronic diseases and other health issues affecting SGM people.

Objective: To determine which nursing home (NH) resident characteristics were most important to clinicians' decision to prescribe antibiotics for a suspected urinary tract infection (UTI), including both evidence-based and non-evidence-based characteristics., Design: Web-based discrete choice experiment with 19 clinical scenarios. For each scenario, clinicians were asked whether they would prescribe an antibiotic for a suspected UTI., Setting: Online survey., Participants: Convenience sample of 876 NH physicians and advanced practice providers who practiced primary care for NH residents in the United States., Methods: Each scenario varied information about 10 resident characteristics regarding urinalysis results, resident temperature, lower urinary tract symptoms, physical examination, antibiotic request, mental status, UTI risk, functional status, goals of care, and resident type. We derived importance scores for the characteristics and odds ratios (ORs) for specific information related to each characteristic from a multinomial logistic regression., Results: Approximately half of the participants were male (56%) with a mean age of 49 years. Resident characteristics differed in their importance (ie, part-worth utility) when deciding whether to prescribe for a suspected UTI: urinalysis results (32%), body temperature (17%), lower urinary tract symptoms (17%), physical examination (15%), antibiotic request (7%), mental status (4%), UTI risk (4%), functional status (3%), goals of care (2%), and resident type (1%). Information about "positive leukocyte esterase, positive nitrates" was associated with highest odds of prescribing [OR 19.6, 95% confidence interval (CI) 16.9, 22.7], followed by "positive leukocyte esterase, negative nitrates" (OR 6.7, 95% CI 5.8, 7.6), and "painful or difficult urination" (OR 4.8, 95% CI 4.2, 5.5)., Conclusions and Implications: Although guidelines focus on lower urinary tract symptoms, body temperature, and physical examination for diagnosing a UTI requiring antibiotics, these characteristics were considered less important than urinalysis results, which have inconsistent clinical utility in NH residents. Point-of-care clinical decision support offers an evidence-based prescribing process., (Copyright © 2019 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: The US Food and Drug Administration has increased communication efforts that aim to raise public awareness of the harmful constituents (ie, chemicals) in cigarette smoke. We sought to investigate whether the public's awareness of these chemicals has increased in light of such efforts., Methods: Participants were national probability samples of 11 322 US adults and adolescents recruited in 2014-2015 (wave 1) and 2016-2017 (wave 2). Cross-sectional telephone surveys assessed awareness of 24 cigarette smoke chemicals at both timepoints., Results: The proportion of US adults aware of cigarette smoke chemicals did not differ between waves 1 and 2 (25% and 26%, p = .19). In contrast, awareness of chemicals among adolescents fell from 28% to 22% (p < .001), mostly due to lower awareness of carbon monoxide, arsenic, benzene, and four other chemicals. Belief that most of the harmful chemicals in cigarette smoke come from burning the cigarette also fell from waves 1 to 2 (adults: 31% vs. 26%; adolescents: 47% vs. 41%, both ps < .05). Participants were more likely to be aware of cigarette smoke chemicals if they had been exposed to anti-smoking campaign advertisements (p < .05) or had previously sought chemical information (p < .05). Cigarette smoke chemical awareness did not differ between smokers and nonsmokers., Conclusion: Awareness of cigarette smoke chemicals remains low and unchanged among adults and decreased somewhat among adolescents. The association of chemical awareness with information exposure via campaigns and information seeking behavior is promising. More concerted communication efforts may be needed to increase public awareness of cigarette smoke chemicals, which could potentially discourage smoking., Implications: Awareness of the toxic chemicals in cigarette smoke may contribute to quitting. The US Food and Drug Administration is making efforts to increase public awareness of these chemicals. Two national surveys (2014-2017) found that chemical awareness was low among adults and adolescents. Although awareness did not change among adults, awareness among adolescents dropped over time. In addition, exposure to anti-smoking campaigns and chemical information seeking behavior were associated with higher awareness of chemicals in cigarette smoke. Campaigns and other efforts may be needed to increase awareness of cigarette smoke chemicals., (© The Author(s) 2019. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background . There are well-documented inequities in smoking between sexual and gender minority (SGM; e.g., lesbian, gay, bisexual, and transgender [LGBT]) and straight and cisgender people. However, there is less information about risk for and resilience against smoking among SGM people. Such information is critical for understanding etiology and developing interventions. Aims . To conduct a within-group assessment of risks and resiliencies relating to smoking status. Method. In 2017, we conducted a cross-sectional telephone survey with a national, probability-based sample of SGM adults ( N = 453). We assessed theory-informed risks (adverse childhood events, substance use-oriented social environment, mental distress, stigma, discrimination, social isolation, and identity concealment) and resiliencies (advertising skepticism, identity centrality, social support, and SGM community participation). We applied survey weights, standardized predictor variables, and fit logistic regression models predicting smoking status. We stratified by age and SGM identity. Results . Patterns of risk and resilience differ by age and identity. Effects were consistently in the same direction for all groups for participating in substance use-oriented social environments, pointing to a potential risk factor for all groups. Advertising skepticism and having people you can talk to about being LGBTQ were potential protective factors. Discussion . Intervention development should address risk and resilience that differs by SGM identity. Additionally, our findings suggest interventionists should consider theoretical frameworks beyond minority stress. Conclusion . While much of the literature has focused on the role of stress from stigma and discrimination in tobacco use, addressing social norms and bolstering protective factors may also be important in SGM-targeted interventions.

Emerging evidence using the concentration of same-sex couples from the U.S. Census suggests lesbian, gay, and bisexual (LGB), and transgender (LGBT; i.e., sexual and gender minority [SGM]) people living as a same-sex couple are concentrated in less healthful neighborhoods. However, it is unclear if findings would be different if based on where LGBT individuals live. Thus, we sought to assess differences in neighborhood, county, and state characteristics between same-sex couples and LGBT individuals to inform population health research and policy interventions on LGBT health inequities. In 2017, we conducted a cross-sectional national, probability survey of LGBT adults in the U.S. and geocoded addresses ( N =407). We linked locations with census tract, county, and state characteristics selected based on health inequities theories. In 2019, we used weighted analysis to calculate descriptive statistics and conducted planned contrasts of location characteristics by both cohabitation status and gender. Many location characteristics were similar by cohabitation status and gender. However, the tract proportion of Black residents and county crime rate were lower for cohabitating than non-cohabitating men. State smoke-free air score was weaker for cohabitating than non-cohabitating women. The use of same-sex couples to determine the geographical clustering of LGBT lives in the U.S. may give a reasonable indication of overall spatial characteristics but can underestimate some important determinants of health. Care should be taken using same-sex couples as a proxy for LGBT concentration when racial segregation is a potential confounder.

Background: Interventionists commonly identify promising messages for health communication efforts based on audience members' ratings of perceived message effectiveness (PME)., Purpose: We sought to validate a new PME measure that improved on existing scales by focusing on the behavior and respondent, being brief, and having strong psychometric properties., Methods: Participants were a national convenience sample of 999 adults and national probability samples of 1,692 adults and 869 adolescents recruited in 2015. Smokers and nonsmokers rated up to six brief messages about the chemicals in cigarette smoke on two PME scales. The first was the new three-item University of North Carolina (UNC) PME Scale that assessed effects perceptions. The second was an established six-item PME scale that assessed message perceptions. We examined the UNC PME Scale's psychometric properties and compared both scales using item factor analysis., Results: The UNC PME Scale measured the same construct across multiple chemical messages (all factor loadings ≥ 0.86). It exhibited high reliability (>0.85) over very low to moderate levels of PME (z = -2.5 to 0.2), a range that is useful for identifying more promising messages. Samples of adults and adolescents showed a similar pattern of results. As expected, the UNC PME Scale was strongly positively correlated with message perceptions (r = .84). It also exhibited strong psychometric properties among participants regardless of education, reactance, sex, and smoking status., Discussion: The UNC PME Scale reliably and validly measured PME among adults and adolescents from diverse groups. This brief scale may be used to efficiently evaluate candidate antismoking messages and may be suitable for adaptation to other health risk behaviors., (© Society of Behavioral Medicine 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: Cancer survivors who smoke cigarettes face health risks from continued smoking. Some smokers use e-cigarettes to reduce combustible cigarette use, but research on whether cancer survivors do the same is limited. Research is needed to understand whether smokers who are cancer survivors use e-cigarettes at higher rates than smokers never diagnosed with cancer, to inform provider-patient discussions about e-cigarettes., Methods: Using cross-sectional data from current cigarette smokers in Wave 1 (2013-2014) of the Population Assessment of Tobacco Health (PATH) study, we compared cancer survivors (n = 433) and those without a prior cancer diagnosis (n = 10,872) on e-cigarette use and reasons for use., Results: Among smokers, 59.4% of cancer survivors and 63.2% of those without a cancer diagnosis had ever used e-cigarettes, and nearly one-quarter of both groups (23.1% and 22.3%, respectively) reported being current users. Multivariate results, however, suggest that cancer survivors might be more likely to be ever (OR = 1.28; p = .05) or current (OR = 1.25; p = .06) e-cigarette users compared to those never diagnosed, although results were marginally significant. The majority of both groups (> 71%) reported using e-cigarettes for perceived health-related reasons-including smoking reduction., Conclusions: Our study found that among smokers, cancer survivors were using e-cigarettes at similar rates as never-diagnosed smokers and both groups used e-cigarettes largely for perceived health-related reasons., Implications for Cancer Survivors: Clinicians who treat cancer survivors may need to routinely ask their patients who smoke about e-cigarette use and address the limited research on the efficacy of e-cigarettes as a cessation aid as compared to other evidence-based options.

Background: Online convenience samples are a quick and low-cost way to study health behavior, but the comparability to findings from probability samples is not yet well understood., Purpose: We sought to compare convenience and probability samples' findings for experiments, correlates, and prevalence in the context of tobacco control research., Methods: Participants were a probability sample of 5,014 U.S. adults recruited by phone from September 2014 through May 2015 (cost ~U.S.$620,000) and an online convenience sample of 4,137 U.S. adults recruited through Amazon Mechanical Turk (MTurk) in December 2014 (cost ~U.S.$17,000). Participants completed a survey with experiments, measures of tobacco product use and demographic characteristics., Results: MTurk convenience and probability samples showed the same pattern of statistical significance and direction in almost all experiments (21 of 24 analyses did not differ) and observational studies (19 of 25 associations did not differ). Demographic characteristics of the samples differed substantially (1 of 17 estimates did not differ), with the convenience sample being younger, having more years of education, and including more Whites and Asians. Tobacco product use also differed substantially (1 of 22 prevalence estimates did not differ), with the convenience sample reporting more cigarette and e-cigarette use (median error 19%)., Conclusions: Using MTurk convenience samples can yield generalizable findings for experiments and observational studies. Prevalence estimates from MTurk convenience samples are likely to be over- or underestimates., (© Society of Behavioral Medicine 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Our randomized trial found that pictorial cigarette pack warnings elicited more quit attempts than text-only warnings., Purpose: In the current study, we sought to identify psychological mechanisms that explain why pictorial cigarette pack warnings change behavior., Methods: In 2014 and 2015, we recruited 2,149 adult smokers in NC and CA, USA. We randomly assigned smokers to receive on their cigarette packs for 4 weeks either a text-only warning (one of the USA's current warnings on the side of cigarette packs) or a pictorial warning (one of the USA's proposed text warnings with pictures on the top half of the front and back of cigarette packs)., Results: Pictorial warnings increased attention to, reactions to, and social interactions about cigarette pack warnings (all p < .05). However, pictorial warnings changed almost no belief or attitude measures. Mediators of the impact of pictorial warnings included increased attention, negative affect, social interactions, thinking about the warning and harms of smoking, and intentions to quit (all p < .05). Analyses also found that pictorial warnings led to greater avoidance of the warnings, which was associated with more quit attempts (p < .05)., Conclusions: Pictorial warnings increased quit attempts by eliciting aversive reactions and by keeping the message vividly in smokers' minds. Contrary to predictions from several theories of health behavior, the warnings exerted little of their influence through changes in beliefs and attitudes and none of their influence through changes in risk perception. We propose the Tobacco Warnings Model based on these findings., Clinical Trial Information: ClinicalTrials.gov identifier: NCT02247908; https://clinicaltrials.gov/ct2/show/NCT02247908., (© Society of Behavioral Medicine 2018. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

: media-1vid110.1542/5972295740001PEDS-VA&#95;2018-1872 Video Abstract OBJECTIVES: We sought to identify effective responses to parents' questions and concerns about human papillomavirus (HPV) vaccine., Methods: In 2017-2018, we surveyed a national sample of 1196 US parents of children aged 9 to 17 years. We recorded brief videos of a pediatrician providing messages that addressed 7 HPV vaccination topics that commonly elicit questions or concerns (eg, recommended age). We randomly assigned parents to 1 of the message topics; parents then viewed 4 videos on that topic in random order and evaluated the messages., Results: Parents were more confident in HPV vaccine when they were exposed to messages that addressed lack of knowledge about HPV vaccine ( b = 0.13; P = .01), messages that included information about cancer prevention ( b = 0.11; P < .001), messages that required a higher reading level ( b = 0.02; P = .01), and messages that were longer ( b = 0.03; P < .001). Parents were less confident in HPV vaccine when exposed to messages in which urgency was expressed ( b = -0.06; P = .005). Analyses conducted by using HPV vaccine motivation as an outcome revealed the same pattern of findings., Conclusions: We provide research-tested messages that providers can use to address parents' HPV vaccination questions and concerns about 7 common topics. Important principles for increasing message effectiveness are to include information on the benefits of vaccination (including cancer prevention) and avoid expressing urgency to vaccinate when addressing parents' questions or concerns. Additionally, providers may need to be prepared to have longer conversations with parents who express concerns about HPV vaccine, especially regarding safety and side effects., Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr Brewer has served on paid advisory boards of and received research grants from Merck, Pfizer, and GlaxoSmithKline; the other authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2019 by the American Academy of Pediatrics.)

Background: The USA can require tobacco companies to disclose information about harmful and potentially harmful chemicals in cigarette smoke, but the impact of these messages is uncertain. We sought to assess the effect of placing messages about toxic chemicals on smokers' cigarette packs., Methods: Participants were 719 adult cigarette smokers from California, USA, recruited from September 2016 through March 2017. We randomly assigned smokers to receive either factual messages about chemicals in cigarette smoke and their health harms (intervention) or messages about not littering cigarette butts (control) on the side of their cigarette packs for 3 weeks. The primary trial outcome was intention to quit smoking., Results: In intent-to-treat analyses, smokers whose packs had chemical messages did not have higher intentions to quit smoking at the end of the trial than those whose packs had control messages (P=0.56). Compared with control messages, chemical messages led to higher awareness of the chemicals (28% vs 15%, P<0.001) and health harms (60% vs 52%, P=0.02) featured in the messages. In addition, chemical messages led to greater negative affect, thinking about the chemicals in cigarettes and the harms of smoking, conversations about the messages and forgoing a cigarette (all P<0.05)., Discussion: Chemical messages on cigarette packs did not lead to higher intentions to quit among smokers in our trial. However, chemical messages informed smokers of chemicals in cigarettes and harms of smoking, which directly supports their implementation and would be critical to defending the messages against cigarette company legal challenges., Trial Registration Number: NCT02785484., Competing Interests: Competing interests: None of the authors have received funding from tobacco product manufacturers. NTB and KMR have served as paid expert consultants in litigation against tobacco companies. The other authors declare no conflicts of interest., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: Pictorial warnings on cigarette packs increase motivation to quit smoking. We sought to examine the potential mediating role of negative affect, message reactance (ie, an oppositional reaction to a message) and perceived risk in shaping quit intentions., Methods: In 2014 and 2015, we randomly assigned 2149 adult US smokers to receive either pictorial warnings or text-only warnings applied to their cigarette packs for 4 weeks. Analyses used structural equation modelling with bootstrapped SEs to test our theorised mediational model., Findings: Pictorial warnings increased negative affect, message reactance and quit intentions (all P<0.001), but not perceived risk (ie, perceived likelihood and severity of harms of smoking). Negative affect mediated the impact of pictorial warnings on quit intentions (mediated effect=0.16, P<0.001). Message reactance weakened the impact of pictorial warnings on quit intentions, although the effect was small (mediated effect=-0.04, P<0.001). Although pictorial warnings did not directly influence perceived risk, the model showed additional small mediation effects on quit intentions through negative affect and its positive association with perceived risk (mediated effect=0.02, P<0.001), as well as reactance and its negative association with perceived risk (mediated effect=-0.01, P<0.001)., Conclusions: Pictorial cigarette pack warnings increased quit intentions by increasing negative affect. Message reactance partially attenuated this increase in intentions. The opposing associations of negative affect and reactance on perceived risk may explain why pictorial warnings did not lead to observable changes in perceived risk., Competing Interests: Competing interests: NTB and KMR have served as paid expert consultants in litigation against tobacco companies., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: Smoking poses significant health risks to cancer survivors. Cancer survivorship may heighten psychological distress and reduce social support and health-related quality of life (HRQOL) for years after diagnosis, which could inhibit long-term successful smoking cessation. Understanding longitudinal associations between these psychosocial characteristics and successful cessation could help clinicians tailor cessation interventions for their patients., Methods: Time-to-event analyses using data from the American Cancer Society Study of Cancer Survivors-I (SCS-I)-a longitudinal nationwide study-examined the relationship of psychosocial characteristics with cessation likelihood and amount of time from diagnosis to quitting in cancer survivors diagnosed 7 to 10 years prior., Results: Cancer survivors with high physical HRQOL were more likely to quit smoking within 10 years from cancer diagnosis than survivors with low physical HRQOL, controlling for cancer type and number of comorbid conditions at baseline (HR = 1.96; 95% CI: 1.10-2.70; P = .02). Survivors with high physical HRQOL also took less time to quit than survivors with low physical HRQOL. Survivors of tobacco-related cancers with low physical HRQOL were the least likely group to quit. No significant relationships between other psychosocial predictors and cessation outcomes were observed., Conclusions: Smoking cessation programs are needed for all cancer survivors who smoke, but survivors with low physical HRQOL 1 year after diagnosis may need more intensive long-term smoking cessation interventions with multiple check-in points after smoking relapses. Cessation interventions that include strategies to mitigate physical symptoms in those with poor physical HRQOL deserve consideration in research and practice., (© 2018 John Wiley & Sons, Ltd.)

Introduction: Cigarette smoke contains at least 93 chemicals or "constituents" that the Food and Drug Administration has identified as harmful and potentially harmful constituents to human health. Our study sought to identify which constituent disclosure message elements are most effective in discouraging people from smoking., Methods: Three hundred eighty eight current smokers aged 18 and older completed an online survey in February 2015. We randomized participants to respond to one of two sets of 13 toxic products that contain cigarette constituents and 25 health effects associated with cigarette constituents., Results: Products that elicited the most discouragement were those with lower chances of exposure (e.g., explosives), followed by products with possible exposure (e.g., rat poison), and products with a high likelihood of exposure (e.g., floor cleaner). Awareness of toxic products that constituents are found in (p < .001) and low exposure products (p < .001) were associated with higher discouragement. Health effects that people had heard are caused by cigarette smoke constituents elicited higher discouragement from smoking cigarettes (p < .001). Cancer was associated with higher discouragement relative to respiratory, cardiovascular, and reproductive health effects (all p < .001)., Conclusions: Cigarette smoke constituent messages may be more effective at discouraging smoking if they include information about carcinogenic health effects (e.g., mouth cancer and lung tumors) and low exposure toxic products (e.g., explosives and radioactive material) as message elements., Implications: Our study identified health effects and toxic products, especially cancers and rarely encountered toxic products, that may discourage smoking when included in disclosure messages. By constructing messages that communicate the harms associated with tobacco use by contextualizing those harms in terms of specific constituents, tobacco education messaging efforts may be increasingly successful.

Background: Pictorial warnings on cigarette packs are a cost-effective policy-level intervention for smoking cessation; however, little research has examined changes in the impact of warnings over time, especially shortly following the first exposure to pictorial warnings. We sought to characterize the trajectories of responses to pictorial cigarette pack warnings soon after first exposure., Methods: Participants were 2149 adult smokers in North Carolina and California, United States. In 2014-2015, we randomized smokers to have pictorial (intervention) or text-only (control) warnings on their cigarette packs for 4 weeks. Weekly surveys assessed psychosocial and behavioral outcomes., Results: After 1 week, smokers in the intervention arm reported higher levels of most outcomes, compared with the control arm. Over subsequent weeks, smokers in both trial arms had decreases in thinking about the harms of smoking (β = -0.046), positive (β = -0.036), and negative (β = -0.042) smoking reinforcement attitudes, and increases in quit intentions (β = 0.070) and cigarette forgoing (β = 0.137) (all p < .05). Only negative affective reactions decreased more in the intervention versus control condition (pinteraction < .01)., Conclusions: The impact of pictorial cigarette pack warnings on emotions and cognitions may wane over time. In contrast, quit intentions and cigarette forgoing may continue to increase, at least during the initial period after introduction. Rotation of pictorial warnings may help prevent warning wear-out., Implications: Cigarette smoking is the leading cause of preventable morbidity and mortality and warnings on cigarette packs are a cost-effective policy-level intervention. Prior studies reporting on cigarette pack warning "wear out" have been limited by being short-term single-session experimental studies. Ours are the first study to experimentally examine the trajectories of several outcomes after first exposure and report that the impact of pictorial cigarette pack warnings on emotions and cognitions may wane over time while quit intentions and cigarette forgoing may continue to increase., Trials Registration: ClinicalTrials.gov identifier: NCT02247908; https://clinicaltrials.gov/ct2/show/NCT02247908.

Introduction: Product packaging has long been used by the tobacco industry to target consumers and manipulate product perceptions. This study examines the extent to which cigarillo packaging influences perceptions of product flavor, taste, smell, and appeal., Methods: A web-based experiment was conducted among young adults. Participants viewed three randomly selected cigarillo packs, varying on pack flavor descriptor, color, type, branding, and warning-totaling 180 pack images. Mixed-effects models were used to estimate the effect of pack elements on product perceptions., Results: A total of 2,664 current, ever, and never little cigar and cigarillo users participated. Cigarillo packs with a flavor descriptor were perceived as having a more favorable taste (β = 0.21, p < .001) and smell (β = 0.14, p < .001) compared to packs with no flavor descriptor. Compared to packs with no color, pink and purple packs were more likely to be perceived as containing a flavor (β = 0.11, p < .001), and were rated more favorably on taste (β = 0.17, p < .001), smell (β = 0.15, p < .001), and appeal (β = 0.16, p < .001). While warnings on packs decreased favorable perceptions of product taste (pictorial: β = -0.07, p = .03) and smell (text-only: β = -0.08, p = .01; pictorial: β = -0.09, p = .007), warnings did not moderate the effects of flavor descriptor or color., Conclusions: To our knowledge, this study provides the first quantitative evidence that cigarillo packaging alters consumers' cognitive responses, and warnings on packs do not suffice to overcome the effects of product packaging. The findings support efforts at federal, state, and local levels to prohibit flavor descriptors and their associated product flavoring in non-cigarette products such as cigarillos, along with new data that supports restrictions on flavor cues and colors.

US law requires the Food and Drug Administration (FDA) to disclose information on harmful and potentially harmful chemicals in cigarette smoke (i.e., constituents) to the public. To inform this effort, we sought to identify principles for creating constituent messages that effectively discourage smoking. Participants were an online convenience sample of 1148 US smokers ages 18+. We developed a library of 76 messages about constituents only and constituents plus contextualizing information (i.e., toxic products that also contain the chemical, health effects, or both). We randomized smokers to receive 1 message from each of 7 message panels in a mixed between-/within-subjects experiment. Participants rated each message on perceived message effectiveness. Results indicated that smokers perceived messages about arsenic, formaldehyde, lead, uranium, and ammonia as more effective than messages about nitrosamines. Messages that contained information on toxic products, health effects, or both received higher effectiveness ratings than constituent-only messages. Among constituent-only messages, those that referenced multiple constituents received higher effectiveness ratings than those with fewer constituents. We conclude that chemical messages may have more impact if they pair known constituents with toxic product or health effect information. These message principles can be used to inform studies examining the impact of constituent messages on smoking beliefs and behavior., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM)., Methods: Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist's perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change., Results: All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α's from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions., Conclusions: The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned.

We sought to identify icons to effectively communicate health harms of chemicals in cigarette smoke. Participants were a convenience sample of 701 U.S. adults. A within-subjects online experiment explored the effects of icon semiotic type: symbolic (arbitrary, most abstract), indexical, and iconic (representative, most concrete). Outcomes were perceived representation, affect toward smoking, elaboration, perceived severity, and perceived effectiveness. For not-easy-to-visualize harms of cancer and addiction, symbolic icons received the highest ratings (all p < .001). For easy-to-visualize symptoms of heart attack/stroke, indexical icons received the highest ratings (all p < .001). For easy-to-visualize harm of reproductive organ damage, the iconic image did best (all p < .001). Icon type often had a larger impact among participants with higher health literacy. Symbolic icons may be most effective for health effects not easily visualized. Iconic or indexical icons may be more effective for health effects attributable to specific body parts or symptoms.

Reactance to persuasive messages involves perceived threat to freedom, anger, and counterarguing that may undermine the impact of health warnings. To understand reactance's effects, reliable and valid assessment is critical. We sought to develop and validate a brief Reactance to Health Warnings Scale (RHWS). Two independent samples of US adults completed the brief RHWS in studies that presented warnings on cigarette packs that smokers carried with them for 4 weeks (Study 1; n = 2149) or as digital images of cigarette packs that participants viewed briefly (Study 2; n = 1413). The three-item Brief RHWS had good internal consistency and test-retest reliability. The scale correlated with higher trait reactance and exposure to pictorial warnings, supporting its convergent validity. With respect to predictive validity, the Brief RHWS predicted perceived message effectiveness, quit intentions, avoidance of the warnings, and number of cigarettes smoked per day. The Brief RHWS can serve as an efficient adjunct to the development of persuasive messages.

Objective: This study explored the association of stress and depression with a multidimensional sleep problems construct in a sample of 2-year college students., Participants: The sample consisted of 440 students enrolled in 2-year study from Fall 2011 to Fall 2013., Methods: Participants in an obesity prevention study completed surveys assessing sleep, stress, and depression at baseline, 4, 12, and 24 months. Multilevel models predicting sleep problems were conducted to distinguish episodic from chronic reports of stress and depression., Results: Participants were primarily women (68%), white (73%), young adults (M age = 22.8), with an average of 8.4 hours of sleep per night. Neither stress nor depression was predictive of sleep quantity; however, they were predictive of sleep quality., Conclusions: Results show that sleep quality rather than sleep quantity may be the greater health concern for young adults, suggesting that intervention programs targeting depression, stress management, and healthy sleep patterns are warranted.

Federal law now requires FDA to disseminate information on chemicals in cigarette smoke, but it is unclear how best to do so. In a 2 × 2 between-subjects experiment, participants received a message about chemicals in cigarette smoke (e.g., "Cigarette smoke has benzene.") along with an additional randomly assigned messaging strategy: a "found-in" (e.g., "This is found in gasoline."), a health effect (e.g., "This causes heart disease."), both, or neither. Participants were U.S. probability phone samples of 5000 adults and 1123 adolescents, and an online convenience sample of 4130 adults. Adding a health effect elicited greater discouragement from wanting to smoke cigarettes (all p < .05) as did adding a found-in (all p < .05). However, including both messaging strategies added little or nothing above including just one. These findings can help the FDA and other agencies develop effective and parsimonious messages about cigarette smoke constituents.

Introduction: The National Academy of Medicine has called for an increase in the minimum age of tobacco product sales. It is not clear what age increase would garner the greatest public support, or whether trust in the U.S. government predicts policy support., Methods: The data for these analyses are from a nationally representative telephone sample of U.S. adults (N=4,880) conducted from September 2014 to May 2015. The authors assessed whether support varied by the proposed minimum age of tobacco sales using a survey experiment (i.e., random assignment to the 19-, 20-, or 21-year age minimum condition) and, in cross-sectional analyses, whether smoking status, individual demographics, state-level politics, and general trust in the government predicted policy support. Analyses were conducted from May to December 2015., Results: Odds of support for raising the minimum sales age to 21 years trended higher than support for raising to age 20 or 19 years (AOR=1.22, 95% CI=0.97, 1.53, p=0.09). There was majority support for raising the age of sales for cigarettes in all regions of the U.S. (66.3%, 95% CI=64.0, 68.6). Race, age, and trust in government were significant predictors of support., Conclusions: Raising the age of tobacco sales is broadly supported by the public. An age 21 years tobacco sales policy trends toward garnering more support than a policy at age 19 or 20 years. Trust in government may be an important consideration in understanding policy support beyond demographics., (Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)