Development and initial validation of a new self-report measure to assess perceived dependence on tobacco and nicotine products.

How nicotine is administered has evolved from cigarettes to various delivery systems. Assessing perceived dependence on nicotine-containing products now requires accounting for product specificity while allowing comparisons across products and users. This study aims to develop a new self-report measure to assess perceived dependence on tobacco and nicotine products (TNPs) among exclusive and poly-TNP users. A draft version of the new measure, the ABOUT-Dependence, was constructed based on literature review, qualitative research, and expert opinion. Data for scale formation and psychometric assessment was obtained through a US-based web survey (n = 2334) that included additional dependence measures for convergent validity assessment. Qualitative research confirmed a preliminary conceptual framework with seven sub-concepts. Following a cognitive debriefing, 19 items were considered to best represent the different sub-concepts. Psychometric findings supported a three-domain structure [i.e., behavioral impact (five items), signs and symptoms (five items), and extent/timing of use (two items)] and an overall total composite score. The data confirmed convergent and known-group validity, as well as test-retest reliability. The ABOUT-Dependence is a 12-item, psychometrically sound, self-report measure that may be used as a tool for research and further understanding of perceived dependence across the spectrum of TNP and TNP users.

Impact of tobacco and/or nicotine products on health and functioning: a scoping review and findings from the preparatory phase of the development of a new self-report measure.

BACKGROUND: Measuring self-reported experience of health and functioning is important for understanding the changes in the health status of individuals switching from cigarettes to less harmful tobacco and/or nicotine products (TNP) or reduced-risk products (RRP) and for supporting tobacco harm reduction strategies. METHODS: This paper presents insights from three research activities from the preparatory phase of the development of a new self-report health and functioning measure. A scoping literature review was conducted to identify the positive and negative impact of TNP use on health and functioning. Focus groups (n = 29) on risk perception and individual interviews (n = 40) on perceived dependence in people who use TNPs were reanalyzed in the context of health and functioning, and expert opinion was gathered from five key opinion leaders and five technical consultants. RESULTS: Triangulating the findings of the review of 97 articles, qualitative input from people who use TNPs, and expert feedback helped generate a preliminary conceptual framework including health and functioning and conceptually-related domains impacted by TNP use. Domains related to the future health and functioning measurement model include physical health signs and symptoms, general physical appearance, functioning (physical, sexual, cognitive, emotional, and social), and general health perceptions. CONCLUSIONS: This preliminary conceptual framework can inform future research on development and validation of new measures for assessment of overall health and functioning impact of TNPs from the consumers' perspective.

Prevalence and patterns of tobacco and/or nicotine product use in Japan (2017) after the launch of a heated tobacco product ( IQOS®): a cross-sectional study.

Background: Several smoke-free tobacco and/or nicotine-containing products (TNP) have emerged in recent years to support tobacco harm reduction strategies and reduce individual health risks and population harm relative to continued cigarette smoking. This paper describes the nationwide prevalence and patterns of TNP use in Japan following the commercialization of one such smoke-free TNP, the heated tobacco product IQOS® (Philip Morris International).   Methods: We analyzed the first annual data (2016-2017) of two repeated cross-sectional surveys conducted in a representative sample of the Japanese general adult population (N = 4,878) and a sample of adult IQOS users (N = 2,000). We assessed the prevalence of current TNP use according to type of product (cigarettes, IQOS, e-cigarettes, and other TNPs) in the general population and patterns of TNP use in the IQOS user sample. Results: The prevalence of current use across all TNP in the general adult population was 18.5% (95% confidence interval 17.2-19.5%), with 17.5% (16.4-18.6%) for cigarette smoking and 1.8% (1.4-2.2%) for IQOS use. With regard to the distribution of patterns of use in the IQOS user survey, the majority (63.4% [61.2-65.6%]) were exclusive users of IQOS, followed by 20.6% (18.7-22.5%) of individuals who reported dual use of IQOS and cigarettes. Conclusions: In Japan, cigarette smoking remains the most prevalent way of consuming TNP; however, IQOS is being adopted by a growing number of adult Japanese smokers. These findings serve as baseline data for monitoring trends over time in the use and adoption of potential smoke-free TNP in Japan.

Do People With Chronic Pain Judge Their Sleep Differently? A Qualitative Study.

People with chronic pain often report sleep of "poor quality." However, it is unclear what defines sleep quality and whether their sleep quality judgment is influenced by factors other than sleep. We purposively interviewed 17 participants with and without chronic pain and thematically analyzed their interview transcripts. Four salient criteria for judging sleep quality were (a) memories of night-time sleep disruptions, (b) feelings on waking and cognitive functioning during the day, (c) ability to engage in daytime physical and social activity, and (d) changes in physical symptoms (and pain intensity among participants with chronic pain). Sleep quality judgment is complex and involves retrospective decision making influenced by not only memories of the night but also how we feel and what we do during the day.

Considerations related to vaping as a possible gateway into cigarette smoking: an analytical review.

Background: Toxicant levels are much lower in e-cigarettes than cigarettes. Therefore, introducing e-cigarettes into the market seems likely to reduce smoking-related diseases (SRD). However, vaping might provide a gateway into cigarette smoking for those who otherwise would never have smoked, a concern fuelled by cohort studies showing vaping predicts subsequent smoking initiation in young people. Methods: In this discussion paper, we consider various aspects of the gateway issue in youths. We provide a descriptive critical review of results from prospective studies relating to the gateway effect and the extent to which the studies considered other potential confounding variables associated with smoking initiation. We then estimate the effects of omitting a confounding variable, or misclassifying it, on the association between vaping and subsequent smoking initiation, and determine how the prevalence of smoking might be affected by any true gateway effects of vaping. Finally, we examine trends in e-cigarette and smoking prevalence in youths based on national surveys. Results: First, we demonstrate that although studies report that vaping significantly predicts smoking initiation following adjustment for various other predictors, the sets of predictors considered are quite incomplete. Furthermore, no study considered residual confounding arising from inaccurate measurement of predictors. More precise adjustment may substantially reduce the association. Second, we show any true gateway effect would likely affect smoking prevalence only modestly. Third, we show smoking prevalence in U.S. and U.K. youths in 2014-2016 declined somewhat faster than predicted by the preceding trend; a substantial gateway effect suggests the opposite. Finally, we argue that even if some gateway effect exists, introducing e-cigarettes still likely reduces SRDs. Conclusions: Given that the existence of any true gateway effect in youth is not yet clearly demonstrated the population health impact of introducing e-cigarettes is still likely to be beneficial.

Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT™ Toolbox initiative.

Background. Determining the public health impact of tobacco harm reduction strategies requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNPs) with different exposure and risk profiles. In this context, rigorous methods to develop and validate psychometrically sound self-report instruments to measure consumers' responses to TNPs are needed. Methods. Consistent with best practice guidelines, including the U.S. Food and Drug Administration's "Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims," scientifically designed, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. Results. This brief report presents the ABOUT™ Toolbox ( Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUT™ Toolbox (i.e., risk perception, dependence, product experience, health and functioning, and use history), and (3) details how the measurement instruments are made accessible to the scientific community. Conclusions. By making the ABOUT™ Toolbox available to the tobacco research and public health community, we envision a rapidly expanding knowledge base, with the goals of (1) supporting consumer perception and behavior research to allow comparisons across a wide spectrum of TNPs, (2) enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and (3) enhancing surveillance activities associated with the impact of TNPs on population health.

Effects of sleep changes on pain-related health outcomes in the general population: A systematic review of longitudinal studies with exploratory meta-analysis.

Emerging longitudinal research has highlighted poor sleep as a risk factor of a range of adverse health outcomes, including disabling pain conditions. In establishing the causal role of sleep in pain, it remains to be clarified whether sleep deterioration over time is a driver of pain and whether sleep improvement can mitigate pain-related outcomes. A systematic literature search was performed using PubMed MEDLINE, Ovid EMBASE, and Proquest PsycINFO, to identify 16 longitudinal studies involving 61,000 participants. The studies evaluated the effect of sleep changes (simulating sleep deterioration, sleep stability, and sleep improvement) on subsequent pain-related outcomes in the general population. A decline in sleep quality and sleep quantity was associated with a two- to three-fold increase in risk of developing a pain condition, small elevations in levels of inflammatory markers, and a decline in self-reported physical health status. An exploratory meta-analysis further revealed that deterioration in sleep was associated with worse self-reported physical functioning (medium effect size), whilst improvement in sleep was associated with better physical functioning (small effect size). The review consolidates evidence that changes in sleep are prospectively associated with pain-related outcomes and highlights the need for further longitudinal investigations on the long-term impact of sleep improvements.

Changes in Sleep Duration, Quality, and Medication Use Are Prospectively Associated With Health and Well-being: Analysis of the UK Household Longitudinal Study.

Introduction: Sleep is a plausible target for public health promotion. We examined the association of changes in sleep with subsequent health and well-being in the general population. Aims and Methods: We analyzed data from the UK Household Longitudinal Survey, involving 30594 people (aged > 16) who provided data on sleep and health and well-being at both Wave 1 (2009-2011) and Wave 4 (2012-2014) assessments. Predicting variables were changes in sleep quantity, sleep quality, and sleep medication use over the 4-year period. Outcome variables were the General Health Questionnaire (GHQ-12) and the 12-Item Short-Form Health Survey (SF-12) mental (MCS) and physical (PCS) component scores at Wave 4. Linear regression on each outcome was fully adjusted for potential confounders and baseline values of the relevant predicting and outcome variables. Results: Better outcomes were associated with an increase in sleep duration (GHQ: ß = 1.031 [95% confidence interval {CI}: -1.328, -0.734]; MCS: 1.531 [1.006, 2.055]; PCS: -0.071 [-0.419, 0.56]), sleep quality (GHQ: ß = -2.031 [95% CI: -2.218, -1.844]; MCS: 3.027 [2.692, 3.361]; PCS: 0.924 [0.604, 1.245]), and a reduction in sleep medication use (GHQ: ß = -1.929 [95% CI: -2.400, -1.459]; MCS: 3.106 [2.279, 3.933]; PCS: 2.633 [1.860, 3.406]). Poorer outcomes were on the other hand associated with a reduction in sleep duration, a decrease in sleep quality, and an increase in sleep medication use. Changes in sleep quality yielded the largest effects on the health and well-being outcomes. Conclusions: Changes in sleep were temporally associated with subsequent health and well-being. Initiatives that aim to protect a critical amount of sleep, promote sleep quality, and reduce sleep medication use may have public health values.

Development of the Pain-Related Beliefs and Attitudes about Sleep (PBAS) Scale for the Assessment and Treatment of Insomnia Comorbid with Chronic Pain.

STUDY OBJECTIVES: Dysfunctional beliefs and attitudes about sleep is a cognitive-behavioral factor central to the development and perpetuation of insomnia. Previous works to unravel the complex interrelationship between pain and insomnia have not explored the role of inflexible beliefs about the sleep-pain interaction, possibly due to a lack of a valid instrument for doing so. The current study evaluated the psychometric and functional properties of a 10-item Pain-Related Beliefs and Attitudes about Sleep (PBAS) scale. METHODS: The PBAS scale was administered to four clinical samples of chronic pain patients with comorbid insomnia: to examine the scale's psychometric properties (n = 137), test-retest reliability (n = 26), sensitivity to treatment (n = 20), and generalizability (n = 62). All participants completed the PBAS together with validated measures of pain interference, insomnia severity, and cognitive-behavioral processes hypothesized to underpin insomnia. RESULTS: The PBAS scale was found to be reliable, with adequate internal consistency and temporal stability. Factor analysis suggested a 2-factor solution representing beliefs about "pain as the primary cause of insomnia" and the "inevitable consequences of insomnia on pain and coping." The PBAS total score was positively correlated with scores from the Insomnia Severity Index (ISI) scale, Dysfunctional Beliefs and Attitudes about Sleep (DBAS) scale, and the Anxiety and Preoccupation about Sleep Questionnaire (APSQ). It was a significant predictor of insomnia severity and pain interference. A significant reduction in PBAS was also observed in patients after receiving a hybrid cognitive-behavioral intervention for both pain and insomnia. CONCLUSIONS: Pain-related sleep beliefs appear to be an integral part of chronic pain patients' insomnia experience. The PBAS is a valid and reliable instrument for evaluating the role of these beliefs in chronic pain patients.