Socioecological factors associated with multiple nicotine product use among U.S. youth: Findings from the population assessment of tobacco and health (PATH) study 2013-2018.

OBJECTIVE: This study utilized a socioecological approach to prospectively identify intrapersonal, familial, and environmental factors associated with single nicotine product use (NPU) and multiple NPU among U.S. youth. METHODS: Participants were 10,029 youths (ages 12-17 years) who had completed the Population Assessment of Tobacco Health study's Wave 1 (2013-2014) and Wave 4 (2016-2018) assessments and data on past 30-day nicotine product use. Multinomial logistic regression was fit for the 3-level outcome (no use, single NPU, multiple NPU) to estimate adjusted associations between the predictors and the outcome. RESULTS: The current study found that intrapersonal (sex, age, race/ethnicity, internalizing symptoms, sensation seeking, harm perceptions, lifetime history of using two or more tobacco products), familial (parental discussion about not using tobacco and living with someone who uses tobacco products) and environmental factors (exposure to tobacco advertising) commonly associated with tobacco use differentiated between individuals who later reported past 30-day NPU (either multiple or single NPU) from those who did not report past 30-day NPU. One familial factor only differentiated between lifetime users who were single NPUs from those who reported no NPU: non-combustible tobacco product use allowed anywhere in the home. Intrapersonal factors differentiated multiple NPU from single NPU: older age, being male, lifetime history of using nicotine product and less harm perceptions. CONCLUSIONS: This study identified factors that may be studied to prevent any NPU, along with factors that may be studied to promote harm reduction by preventing escalation of single NPU to problematic patterns of multiple NPU.

Sex differences in appeal, reward, and sensory experience of E-cigarette flavors among adults who smoke cigarettes.

OBJECTIVE: Flavors enhance nicotine e-cigarette appeal by altering sensory experience. Females may be more sensitive to tobacco-associated cues and uniquely affected by flavor. The current study is an exploratory analysis to examine differences by sex on reward, appeal, and sensory experience of popular e-cigarette flavors. METHODS: Adults (N = 121) who use cigarettes (≥1 cigarette/day) were enrolled in a laboratory study in which they vaped four e-cigarette flavors (tobacco, cherry, menthol, vanilla; in separate lab sessions) in one of two freebase nicotine concentrations (6 mg/ml,18 mg/ml). Following exposures, participants rated e-cigarette reward using the Drug Effects Questionnaire (DEQ), flavor and overall e-cigarette appeal using Labeled Hedonic Scales (LHS), and intensity of flavor, irritation, coolness, fruitiness, and sweetness using Generalized Labeled Magnitude Scales (gLMS). Linear mixed models were conducted for outcomes to analyze effects of sex, flavor, and sex x flavor interaction. RESULTS: For DEQ ratings, there was a trend (p = .08) toward a sex x flavor interaction, in which menthol flavor produced more reward than other flavors for females, but not males. For LHS ratings, there was a significant sex x flavor interaction (p = .03) for overall e-cigarette experience with females but not males rating menthol higher than other flavors. All gLMS scales but irritation showed that females generally had greater differences between flavors compared to males (ps ≤ 0.03). CONCLUSION: Menthol in e-cigarettes may play an important role in mediating appeal and/or reward among females. This may be due in part to their ability to better detect sensory effects of e-cigarettes.

Reprint of: Sex differences in appeal, reward, and sensory experience of E-cigarette flavors among adults who smoke cigarettes.

OBJECTIVE: Flavors enhance nicotine e-cigarette appeal by altering sensory experience. Females may be more sensitive to tobacco-associated cues and uniquely affected by flavor. The current study is an exploratory analysis to examine differences by sex on reward, appeal, and sensory experience of popular e-cigarette flavors. METHODS: Adults (N = 121) who use cigarettes (≥1 cigarette/day) were enrolled in a laboratory study in which they vaped four e-cigarette flavors (tobacco, cherry, menthol, vanilla; in separate lab sessions) in one of two freebase nicotine concentrations (6 mg/ml,18 mg/ml). Following exposures, participants rated e-cigarette reward using the Drug Effects Questionnaire (DEQ), flavor and overall e-cigarette appeal using Labeled Hedonic Scales (LHS), and intensity of flavor, irritation, coolness, fruitiness, and sweetness using Generalized Labeled Magnitude Scales (gLMS). Linear mixed models were conducted for outcomes to analyze effects of sex, flavor, and sex x flavor interaction. RESULTS: For DEQ ratings, there was a trend (p = .08) toward a sex x flavor interaction, in which menthol flavor produced more reward than other flavors for females, but not males. For LHS ratings, there was a significant sex x flavor interaction (p = .03) for overall e-cigarette experience with females but not males rating menthol higher than other flavors. All gLMS scales but irritation showed that females generally had greater differences between flavors compared to males (ps ≤ 0.03). CONCLUSION: Menthol in e-cigarettes may play an important role in mediating appeal and/or reward among females. This may be due in part to their ability to better detect sensory effects of e-cigarettes.

Distinguishing probable atypical anorexia nervosa from weight loss alone in a national sample of U.S. Military Veterans: Disentangling the roles of weight suppression and cognitive concerns.

OBJECTIVE: Veterans are at high risk for eating disorders (EDs), and specifically for atypical anorexia nervosa (atypical AN). The current study aimed to better understand this under-studied disorder and how it differs from weight loss without ED cognitive features. METHOD: Secondary analyses were conducted with data from a national study of Veterans (N = 882, 49.4% women). Participants were categorized into four mutually exclusive groups using the Eating Disorder Diagnostic Scale 5: probable atypical AN, a cognitive concerns group (Cog Only), a weight suppressed group (WS Only), and a no ED control group. Adjusted regression models were used to compare groups on measures of eating pathology and mental health. Three weight suppression thresholds (5%, 10%, and 15%) for probable atypical AN were also tested. RESULTS: The sample was comprised of 12% probable atypical AN, 23.6% Cog Only, 16.3% WS Only, and 48.1% Control. The probable atypical AN group was most like the Cog Only group except for higher levels of dietary restraint. Atypical AN fared worse and was least like the Control group followed by the WS Only group. All weight suppression thresholds significantly predicted dietary restraint, with 5% being the best predictor. DISCUSSION: Results found that probable atypical AN is a distinct clinical entity and that the exact weight suppression threshold associated with atypical AN is less important than having any weight suppression. Findings highlight the clinical significance of atypical AN and the importance of gaining a better understanding of how to address this clinical entity. PUBLIC SIGNIFICANCE: Atypical anorexia nervosa is a relatively underexamined but highly prevalent eating disorder in the Veteran population. Results show that ED cognitive features are more closely linked to clinically significant eating pathology and poor mental health than weight suppression alone suggesting that negative thinking about weight gain and appearance, regardless of the presence or severity of weight loss, may signal the need for specialized intervention.

A randomized controlled trial of potential tobacco policies prohibiting menthol flavor in cigarettes and e-cigarettes: a study protocol.

BACKGROUND: Menthol cigarette use remains a large public health problem and disproportionately affects Black adults in the United States. The Food and Drug Administration has proposed prohibiting menthol flavor in cigarettes to protect public health. However, e-cigarettes are available in menthol flavor and are a popular alternative product adults might switch to if menthol is prohibited in cigarettes. Research is needed to understand how availability of menthol (vs. tobacco) flavored e-cigarettes could impact cigarette use among adults who smoke menthol cigarettes. METHODS: We will recruit 150 adults who currently smoke menthol cigarettes and will randomize them to 1 of 3 conditions modeling different regulatory scenarios. We will recruit equal numbers of participants identifying as Black vs. non-Black and will stratify randomization by race. To promote standardization and adherence, cigarette and e-cigarette products will be provided for 8 weeks based on the assigned condition: (A) no menthol restriction (menthol cigarette and menthol flavored e-cigarette), (B) menthol prohibited in cigarettes only (non-menthol cigarette and menthol flavored e-cigarette), (C) menthol prohibited in both cigarettes and e-cigarettes (non-menthol cigarette and tobacco flavored e-cigarette). A follow-up visit will occur at week 12 to assess tobacco use status. The study aims are to (1) examine the impact of prohibiting menthol flavor in cigarettes and e-cigarettes on smoking behavior and (2) investigate whether outcomes differ by race to understand the impact of menthol policies on Black (vs. non-Black) individuals given high rates of menthol cigarette use in this population. The primary outcome will evaluate changes in the number of cigarettes smoked per day during the 8-week study period and will examine differences by regulatory scenario. Secondary outcomes will compare percent days smoke-free, changes in nicotine dependence, and motivation, confidence, and intentions to quit smoking by the regulatory scenarios. We will examine whether changes in the outcomes differ by Black vs. non-Black participants to compare the magnitude of the effect of the various menthol policy scenarios by race. DISCUSSION: Results will contribute critical information regarding menthol in cigarettes and e-cigarettes to inform regulatory policies that maximize reductions in cigarette smoking and reduce tobacco-related health disparities. TRIAL REGISTRATION: NCT05259566. Yale IRB protocol #2000032211, last approved 12/8/2023.

Development and Psychometric Assessment of the Weight and Eating Quality of Life (WE-QOL) Scale in US Military Veterans.

BACKGROUND: The Veterans Health Administration (VHA) is in need of population health approaches to address overweight and obesity-related diseases. BMI serves as a simple, blunt metric to monitor these efforts. However, emerging research has demonstrated that healthcare weigh-ins contribute to weight stigma which paraodoxically is associated with weight gain. An alternative metric is urgently needed for VHA's MOVE!® Weight Management Program and other eating- and weight-related services. OBJECTIVE: To develop a brief population health metric called the Weight and Eating Quality of Life (WE-QOL) Scale and assess its psychometric properties. DESIGN: The literature was reviewed for relevant weight- and eating-specific QOL measures to identify unique and overlapping constructs. Eight items, representing these constructs, comprised the new brief WE-QOL Scale. A survey study was conducted with data analyzed in STATA. PARTICIPANTS: A total of 213 consecutively evaluated US Veterans attending an orientation session for MOVE!. MAIN MEASURES: The WE-QOL Scale, as well as a widely used generic health-related QOL measure, the European Quality of Life Screener (EQ-ED-5L), and relevant validated measures. KEY RESULTS: WE-QOL descriptive findings demonstrated severe impacts on physical activity and physical discomfort for approximately 30% of the sample each; moderate-to-severe impacts on daily responsibilities, emotional distress, and shame and guilt for one-third of the sample each and public distress for one-fourth of the sample. The WE-QOL Scale performed as well as, or better than, the EQ-ED-5L for internal consistency (Cronbach's alpha = 0.91) and associations to relevant constructs (BMI, eating pathology, and physical activity). CONCLUSIONS: Findings support the reliability and construct validity of the WE-QOL Scale. The WE-QOL Scale has potential to provide a standardized population health metric that could be used as a screening tool and clinical reminder to identify, refer, and assess outcomes for Veterans with weight and disordered eating issues. Future research could be targeted at using this measure to improve patient care and quality of care.

Comparative effectiveness of group v. individual trauma-focused treatment for posttraumatic stress disorder in veterans.

BACKGROUND: Cognitive processing therapy (CPT) and prolonged exposure (PE) delivered in an individual setting are efficacious and effective treatments for veterans with posttraumatic stress disorder (PTSD). Group CPT has been shown to be less efficacious than individual CPT, however, evidence regarding real-world effectiveness is limited. METHODS: We conducted a retrospective, observational, comparative effectiveness study including veterans that received at least eight sessions of group CPT, individual CPT, or individual PE, and were discharged from PTSD residential treatment at the Department of Veterans Affairs between 1 October 2015, and 30 September 2020. PTSD symptom severity was assessed with the PTSD Checklist for DSM-5 (PCL-5) and treatments delivered in a group (CPT) or individual (CPT or PE) setting were compared at discharge and 4-month post-discharge follow-up. RESULTS: Of 6735 veterans, 3888 [653 women (17%), median (IQR) age 45 (35-55) years] received individual and 2847 [206 women (7.2%), median (IQR) age 42 (34-54)] received group therapy. At discharge, improvement in PTSD severity was statistically greater among those treated individually (mean difference on the PCL-5, 2.55 (95% CI 1.61-3.49); p = <0.001]. However, the difference was smaller than the minimal clinically important difference of 7.9 points. The groups did not differ significantly at 4-month follow-up [mean difference on the PCL-5, 0.37 (95% CI -0.86 to 1.60); p = 0.551]. CONCLUSION: Group CPT was associated with a slightly smaller reduction of PTSD symptom severity than individual CPT or PE in veterans at the end of residential treatment. There were no differences at 4-month follow-up.

The first nicotine product tried is associated with current multiple nicotine product use and nicotine dependence among a nationally representative sample of U.S. youths.

This study examines the demographic factors associated with youths' first product tried (i.e., cigarettes, e-cigarettes, cigars, hookah, or smokeless tobacco). This study also evaluates whether the first product tried is associated with future nicotine product use (i.e., no use, single product use, and multiple product use) and nicotine dependence. Participants were 1999 youths (ages 12-17 years) who had ever tried a nicotine product and completed the Population Assessment of Tobacco Health study's Wave 1 (2013-2014) and Wave 4 (2016-2018) assessments. Two separate multinomial logistic regression models examined the association between 1) demographic factors and the first product tried at Wave 1 and 2) the first product tried at Wave 1 and past-30-day product use status at Wave 4. A two-part multivariable model examined the association between the first product tried and nicotine dependence, with part 1 modeling the presence (or absence) of any symptom of dependence and part 2 modeling the degree of dependence among those with any symptom of dependence. The first product tried was associated with sex, race, urbanicity, and parent education. First trying smokeless tobacco (vs. e-cigarettes) was associated with a greater likelihood of multiple product use (vs. no use and vs. single product use). Regarding the degree of nicotine dependence (n = 713), first trying smokeless tobacco (vs. e-cigarettes) was associated with higher nicotine dependence scores among those with any symptom of dependence. Youths who first try smokeless tobacco (vs. e-cigarettes) may be at higher risk for future multiple product use and more symptoms nicotine dependence. Research should explore tailored interventions for smokeless tobacco users.

Models for Zero-Inflated and Overdispersed Correlated Count Data: An Application to Cigarette Use.

INTRODUCTION: Count outcomes in tobacco research are often analyzed with the Poisson distribution. However, they often exhibit features such as overdispersion (variance larger than expected) and zero inflation (extra zeros) that violate model assumptions. Furthermore, longitudinal studies have repeated measures that generate correlated counts. Failure to account for overdispersion, zero inflation, and correlation can yield incorrect statistical inferences. Thus, it is important to familiarize researchers with proper models for such data. AIMS AND METHODS: Poisson and Negative Binomial models with correlated random effects with and without zero inflation are presented. The illustrative data comes from a study comparing a mindfulness training app (Craving to Quit [C2Q], n = 60) with a control app (experience sampling-only app, n = 66) on smoking frequency at 1, 3, and 6 months. Predictors include app, time, the app-by-time interaction, and baseline smoking. Each model is evaluated in terms of accounting for zero inflation, overdispersion, and correlation in the data. Emphasis is placed on evaluating model fit, subject-specific interpretation of effects, and choosing an appropriate model. RESULTS: The hurdle Poisson model provided the best fit to the data. Smoking abstinence rates were 33%, 32%, and 28% at 1, 3, and 6 months, respectively, with variance larger than expected by a factor >7 at each follow-up. Individuals on C2Q were less likely to achieve abstinence across time but likely to smoke fewer cigarettes if smoking. CONCLUSIONS: The models presented are specifically suited for analyzing correlated count outcomes and account for zero inflation and overdispersion. We provide guidance to researchers on the use of these models to better inform nicotine and tobacco research. IMPLICATIONS: In tobacco research, count outcomes are often measured repeatedly on the same subject and thus correlated. Such outcomes often have many zeros and exhibit large variances relative to the mean. Analyzing such data require models specifically suited for correlated counts. The presented models and guidelines could improve the rigor of the analysis of correlated count data and thus increase the impact of studies in nicotine and tobacco research using such outcomes.

Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) has a strong evidence base, but little is known about when treatment benefits are achieved. The present study is a secondary analysis of individuals with chronic back pain recruited for a noninferiority trial comparing interactive voice response (IVR) CBT-CP with in-person CBT-CP. METHODS: On the basis of data from daily IVR surveys, a clinically meaningful change was defined as a 30% reduction in pain intensity (n = 108) or a 45% increase in daily steps (n = 104) compared with the baseline week. We identified individuals who achieved a meaningful change at any point during treatment, and then we compared those who maintained a meaningful change in their final treatment week (i.e., responders) with those who did not or who achieved a meaningful change but lapsed (i.e., nonresponders). RESULTS: During treatment, 46% of participants achieved a clinically meaningful decrease in pain intensity, and 66% achieved a clinically significant increase in number of steps per day. A total of 54% of patients were classified as responders in terms of decreases in pain intensity, and 70% were responders in terms of increases in step count. Survival analyses found that 50% of responders first achieved a clinically meaningful change by week 4 for pain intensity and week 2 for daily steps. Dropout and demographic variables were unrelated to responder status, and there was low agreement between the two measures of treatment response. CONCLUSIONS: Collectively, results suggest that most responders improve within 4 weeks. Evaluating treatment response is highly specific to the outcome measure, with little correlation across outcomes.

Joint longitudinal trajectories of pain intensity and opioid prescription in veterans with back pain.

PURPOSE: We describe pain intensity and opioid prescription jointly over time in Veterans with back pain to better understand their relationship. METHODS: We performed a retrospective cohort study on electronic health record data from 117 126 Veterans (mean age 49.2 years) diagnosed with back pain in 2015. We used latent class growth analysis to jointly model pain intensity (0-10 scores) and opioid prescriptions over 2 years to identify classes of individuals similar in their trajectory of pain and opioid over time. Multivariable multinomial logit models assessed sociodemographic and clinical predictors of class membership. RESULTS: We identified six trajectory classes: a "no pain/no opioid" class (22.2%), a "mild pain/no opioid" class (45.0%), a "moderate pain/no opioid" class (24.6%), a "moderate, decreasing pain/decreasing opioid" class (3.3%), a "moderate pain/high opioid" class (2.6%), and a "moderate, increasing pain/increasing opioid" class (2.3%). Among those in moderate pain classes, being white (vs. non-white) and older were associated with higher odds of being prescribed opioids. Veterans with mental health diagnoses had increased odds of being in the painful classes versus "no pain/no opioid" class. CONCLUSION: We found distinct patterns in the long-term joint course of pain and opioid prescription in Veterans with back pain. Understanding these patterns and associated predictors may help with development of targeted interventions for patients with back pain.

Is Patient-Physician Gender Concordance Related to the Quality of Patient Care Experiences?

BACKGROUND: There is great interest in identifying factors that are related to positive patient experiences such as physician communication style. Documented gender-specific physician communication and patient behavior differences raise the question of whether gender concordant relationships (i.e., both the provider and patient share the same gender) might affect patient experiences. OBJECTIVE: Assess whether patient experiences are more positive in gender concordant primary care relationships. DESIGN: Statewide telephone surveys. Linear mixed regression models to estimate the association of CAHPS scores with patient gender and gender concordance. SUBJECTS: Two probability samples of primary care Medicaid patients in Connecticut in 2017 (5/17-7/17) and 2019 (7/19-10/19). MAIN MEASURES: Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) survey augmented with questions about aspects of care most salient to PCMH-designated organizations and two questions to assess access to mental health services. KEY RESULTS: There were no significant effects of gender concordance and differences in experiences by patient gender were modest. CONCLUSIONS: This study did not support the suggestion that patient and physician gender and gender concordance have an important effect on patient experiences.

Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention.

We examined the effectiveness and safety of a walking program offered as part of cognitive behavioral therapy for chronic pain (CBT-CP). Participants were randomized to 10 weeks of CBT-CP, delivered either in person or by interactive voice response. Participants reported pedometer-measured step counts daily throughout treatment and received a weekly goal to increase their steps by 10% over the prior week's average. Walking-related adverse events (AEs) were assessed weekly. Participants (n = 125) were primarily male (72%), and white (80%) with longstanding pain (median: 11 years). There was no significant difference between treatment groups in rate of change in daily steps, but there was a significant increase in steps from baseline to treatment termination in the combined study sample (1648 steps (95% CI 1063-2225)). Participants classified as active doubled. AEs were mostly minor and temporary. Treatment was effective and safe whether the program was delivered in-person or remotely.Trial registration number: clinicaltrials.gov identifier: NCT01025752.

Two-part models for repeatedly measured ordinal data with "don't know" category.

Ordinal data (eg, "low," "medium," "high"; graded response on a Likert scale) with an additional "don't know" category are frequently encountered in the medical, social, and behavioral science literature. The handling of a "don't know" option presents unique challenges as it often "destroys" the ordinal nature of the data. Commonly, nominal models are employed which ignore the partial ordering and have a complicated interpretation, especially in situations with repeatedly measured outcomes. We propose two-part models that easily accommodate longitudinal partially ordered (semiordinal) data. The most easily interpretable formulation consists of a random effect logistic submodel for "don't know" vs all the other categories combined, and a random effect ordinal submodel for the ordered categories. Correlated random effects account for statistical dependence within individual. An extension allowing for nonproportionality of odds for the predictor effects in the ordinal submodel is also considered. Maximum likelihood estimation is performed using adaptive Gaussian quadrature in SAS PROC NLMIXED. A simulation study is performed to evaluate the performance of the estimation algorithm in terms of bias and efficiency, and to compare the results of joint and separate models of the two parts, and of proportional and nonproportional model formulations. The methods are motivated and illustrated on a dataset from a study of adolescents' perceptions of nicotine strength of JUUL e-cigarettes. Using the proposed approach we show that adolescents perceive 5% nicotine content as relatively low, a misconception more pronounced among past month nonusers than among past month users of JUUL e-cigarettes.

Using Latent Class Analysis to Examine Susceptibility to Various Tobacco Products Among Adolescents.

INTRODUCTION: Most tobacco use is initiated during adolescence and susceptibility is an important predictor of initiation. Research is needed to understand susceptibility across tobacco products among youth to inform prevention efforts. AIMS AND METHODS: We surveyed 2945 students from four Southeastern Connecticut high schools in 2017. We assessed susceptibility to future use of seven different tobacco products (ie, cigarettes, e-cigarettes, hookah, cigars, cigarillos, blunts, and smokeless tobacco) among youth who had never used a tobacco product. Susceptibility was coded as any response other than "definitely not" to three items assessing (1) curiosity, (2) willingness to experiment with the product in the future, and (3) willingness to try if offered by a friend. Latent class analysis was used to identify patterns of susceptibility across multiple tobacco products and sociodemographic predictors of these classes. RESULTS: Among n = 1246 youth who had never tried a tobacco product, 51.2% (n = 638) were susceptible to at least one product and 29.1% (n = 363) were susceptible to two or more products (average among susceptible youth: M = 2.4 products, SD = 1.7, range 1-7). Latent class analysis identified three classes: youth who were: (1) susceptible to all products (5.6%), (2) susceptible to e-cigarettes, hookah, and blunts (23.6%), and (3) mostly non-susceptible to all products (70.8%). In a multivariable model, demographic variables and peer tobacco use predicted class membership. CONCLUSIONS: We observed high rates of susceptibility to non-traditional tobacco products among youth, and many youth were susceptible to more than one product. Targeting susceptibility across multiple tobacco products may be important for reducing youth tobacco use. IMPLICATIONS: Patterns of polytobacco use susceptibility were identified among youth who had never previously used tobacco products. Many youth were susceptible to more than one product and we observed three distinct classes of susceptibility among youth: those who were mostly non-susceptible, those who were susceptible to alternative or non-traditional tobacco products (e-cigarettes, hookah, and blunts), and those who were susceptible to all tobacco products. These findings suggest the importance of addressing susceptibility across multiple tobacco products.

Data Visualization Tools of Tobacco Product Use Patterns, Transitions and Sex Differences in the PATH Youth Data.

INTRODUCTION: Evaluations of multiple tobacco product use and temporal changes in patterns of use are complicated by a large number of combinations and transitions. Visualization tools could easily identify most common patterns and transitions. METHODS: Set intersection bar plots describe ever use of five tobacco products among 12-17 years old youth in wave 1 of the Population Assessment of Tobacco and Health (PATH) study (N = 11 497). Heat maps visualize unweighted frequencies of transitions from ever use at wave 1 (2013-2014) to past 12-month use at wave 2 (2014-2015). Weighted calibrated heat maps assess differences in relative frequencies of transitions by pattern at wave 1 and identify differences in transitions by sex. RESULTS: The most common tobacco product ever use patterns in wave 1 were of cigarettes only, e-cigarettes only or hookah only, followed by ever use of both cigarettes and e-cigarettes. Initiation of use between waves was uncommon. The most frequent transition among those who reported use at wave 2 but not at wave 1 (N = 971) was to e-cigarette use (N = 301). However, among e-cigarette-only ever users at wave 1 (N = 260), about half did not report any product use at wave 2. Use of three or more products remained stable. Adolescent girls compared to boys appeared more likely to report hookah use at both waves. CONCLUSION: Set intersection bar plots and heat maps are useful for visualizing tobacco product use patterns and transitions, especially for multiple products. Both techniques could identify common problematic tobacco use patterns across and within populations. IMPLICATIONS: Given the growing complexity of the youth tobacco use landscape, approaches to efficiently communicate patterns of multiple tobacco product use should be used more often. This study introduces set intersection bar plots and modified versions of heat maps to the tobacco product literature and illustrates their use in the PATH youth sample. These techniques are useful for visualizing absolute and relative frequencies of multiple possible patterns and transitions. They also suggest targets for subsequent statistical inference such as sex differences in hookah use. The methods can be applied more generally for data visualization wherever large number of combinations occurs.

Co-Operative Pain Education and Self-management (COPES) Expanding Treatment for Real-World Access (ExTRA): Pragmatic Trial Protocol.

BACKGROUND: Given access barriers to cognitive behavioral therapy for chronic pain (CBT-CP), this pragmatic superiority trial will determine whether a remotely delivered CBT-CP intervention that addresses these barriers outperforms in-person and other synchronous forms of CBT-CP for veterans with musculoskeletal pain. DESIGN: This pragmatic trial compares an asynchronous form of CBT-CP that uses interactive voice response (IVR) to allow patients to participate from their home (IVR CBT-CP) with synchronous CBT-CP delivered by a Department of Veterans Affairs (VA) clinician. Veterans (n=764; 50% male) with chronic musculoskeletal pain throughout nine VA medical centers will participate. The primary outcome is pain interference after treatment (4 months). Secondary outcomes, including pain intensity, depression symptom severity, sleep, self-efficacy, and global impression of change, are also measured after treatment. Where possible, outcomes are collected via electronic health record extraction, with remaining measures collected via IVR calls to maintain blinding. Quantitative and qualitative process evaluation metrics will be collected to evaluate factors related to implementation. A budget impact analysis will be performed. SUMMARY: This pragmatic trial compares the outcomes, cost, and implementation of two forms of CBT-CP as delivered in the real-world setting. Findings from the trial can be used to guide future policy and implementation efforts related to these interventions and their use in the health system. If one of the interventions emerges as superior, resources can be directed to this modality. If both treatments are effective, patient preferences and health care system factors will take precedence when making referrals. Implications of COVID-19 on treatment provision and trial outcomes are discussed.

The Relationship Between Body Mass Index and Pain Intensity Among Veterans with Musculoskeletal Disorders: Findings from the MSD Cohort Study.

OBJECTIVE: To examine the relationship between body mass index (BMI) and pain intensity among veterans with musculoskeletal disorder diagnoses (MSDs; nontraumatic joint disorder; osteoarthritis; low back, back, and neck pain). SETTING: Administrative and electronic health record data from the Veterans Health Administration (VHA). SUBJECTS: A national cohort of US military veterans with MSDs in VHA care during 2001-2012 (N = 1,759,338). METHODS: These cross-sectional data were analyzed using hurdle negative binomial models of pain intensity as a function of BMI, adjusted for comorbidities and demographics. RESULTS: The sample had a mean age of 59.4, 95% were male, 77% were white/Non-Hispanic, 79% were overweight or obese, and 42% reported no pain at index MSD diagnosis. Overall, there was a J-shaped relationship between BMI and pain (nadir = 27 kg/m2), with the severely obese (BMI ≥ 40 kg/m2) being most likely to report any pain (OR vs normal weight = 1.23, 95% confidence interval = 1.21-1.26). The association between BMI and pain varied by MSD, with a stronger relationship in the osteoarthritis group and a less pronounced relationship in the back and low back pain groups. CONCLUSIONS: There was a high prevalence of overweight/obesity among veterans with MSD. High levels of BMI (>27 kg/m2) were associated with increased odds of pain, most markedly among veterans with osteoarthritis.

A quasi-experiment assessing the six-months effects of a nurse care coordination program on patient care experiences and clinician teamwork in community health centers.

BACKGROUND: Recognition that coordination among healthcare providers is associated with better quality of care and lower costs has increased interest in interventions designed to improve care coordination. One intervention is to add care coordination to nurses' role in a formal way. Little is known about effects of this approach, which tends to be pursued by small organizations and those in lower-resource settings. We assessed effects of this approach on care experiences of high-risk patients (those most in need of care coordination) and clinician teamwork during the first 6 months of use. METHODS: We conducted a quasi-experimental study using a clustered, controlled pre-post design. Changes in staff and patient experiences at six community health center practice locations that introduced the added-role approach for high-risk patients were compared to changes in six locations without the program in the same health system. In the pre-period (6 months before intervention training) and post-period (about 6 months after intervention launch, following 3 months of training), we surveyed clinical staff (N = 171) and program-qualifying patients (3007 pre-period; 2101 post-period, including 113 who were enrolled during the program's first 6 months). Difference-in-differences models examined study outcomes: patient reports about care experiences and clinician-reported teamwork. We assessed frequency of patient office visits to validate access and implementation, and contextual factors (training, resources, and compatibility with other work) that might explain results. RESULTS: Patient care experiences across all high-risk patients did not improve significantly (p > 0.05). They improved somewhat for program enrollees, 5% above baseline reports (p = 0.07). Staff-perceived teamwork did not change significantly (p = 0.12). Office visits increased significantly for enrolled patients (p < 0.001), affirming program implementation (greater accessing of care). Contextual factors were not reported as problematic, except that 41% of nurses reported incompatibility between care coordination and other job demands. Over 75% of nurses reported adequate training and resources. CONCLUSIONS: There were some positive effects of adding care coordination to nurses' role within 6 months of implementation, suggesting value in this improvement strategy. Addressing compatibility between coordination and other job demands is important when implementing this approach to coordination.

Internet-Based Pain Self-Management for Veterans: Feasibility and Preliminary Efficacy of the Pain EASE Program.

OBJECTIVE: To develop and test the feasibility and preliminary efficacy of a cognitive behavioral therapy-based, internet-delivered self-management program for chronic low back pain (cLBP) in veterans. METHODS: Phase I included program development, involving expert panel and participant feedback. Phase II was a single-arm feasibility and preliminary efficacy study of the Pain e-health for Activity, Skills, and Education (Pain EASE) program. Feasibility (ie, website use, treatment credibility, satisfaction) was measured using descriptive methods. Mixed models were used to assess mean within-subject changes from baseline to 10 weeks post-baseline in pain interference (primary outcome, West Haven-Yale Multidimensional Pain Inventory, scale of 0 to 6), pain intensity, mood, fatigue, sleep, and depression. RESULTS: Phase I participants (n = 15) suggested modifications including style changes, content reduction, additional "Test Your Knowledge" quizzes, and cognitive behavioral therapy skill practice monitoring form revisions for enhanced usability. In Phase II, participants (n = 58) were mostly male (93%) and White (60%), and had an average age of 55 years (standard deviation [SD] = 12) and moderate pain (mean score 5.9/10); 41 (71%) completed the post-baseline assessment. Participants (N = 58) logged on 6.1 (SD = 8.6) times over 10 weeks, and 85% reported being very or moderately satisfied with Pain EASE. Pain interference improved from a mean of 3.8 at baseline to 3.3 at 10 weeks (difference 0.5 [95% confidence interval 0.1 to 0.9], P = 0.008). Within-subject improvement also occurred for some secondary outcomes, including mood and depression symptoms. DISCUSSION: Veterans with cLBP may benefit from technology-delivered interventions, which may also reduce pain interference. Overall, veterans found that Pain EASE, an internet-based self-management program, is feasible and satisfactory for cLBP.