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BackgroundA Delphi study was conducted to reach a consensus among international clinical and health care experts on the most important health and functioning self-reported concepts when evaluating a switch from smoking cigarettes to using smoke-free tobacco and/or nicotine products (sf-TNPs). ObjectiveThe aim of this research was to identify concepts considered important to measure when assessing the health and functioning status of users of tobacco and/or nicotine products. MethodsExperts (n=105), including health care professionals, researchers, and policy makers, from 26 countries with professional experience and knowledge of sf-TNPs completed a 3-round, adapted Delphi panel. Online surveys combining quantitative (MaxDiff best-worst scaling and latent class analysis) and qualitative assessments were used to rank and achieve alignment on the importance of 69 health and functioning concepts. All experts participating in round I completed round II, and 101 (95%) completed round III. ResultsThe round I analysis identified 36 (52%) out of 69 concepts that were refined for the round II assessment. The highest-ranked concepts reflected health-related impacts, while the lowest-ranked ranked concepts were related to aesthetics and social impacts. Round II ranking reinforced the importance of concepts relating to health impacts, and the analysis resulted in 20 concepts retained for round III assessment. In round III, the 4 highest-ranked concepts were cardiovascular symptoms, shortness of breath, chest pain, and worry about smoking-related diseases and impact on general health, and they made up 50% of the total score in the MaxDiff analysis. Experts reported likelihood of seeing measurable levels of change in the final 20 concepts with a switch to an sf-TNP. The majority of experts felt it was “likely” or “extremely likely” to observe changes in concepts such as gum problems (74/101, 73%), phlegm or mucus while coughing or not coughing (72/101, 71%), general perception of well-being (72/101, 71%), and throat irritation or sore throat (72/101, 71%). Latent class analysis revealed subgroups of experts with different perceptions of the relative importance of the concepts, which varied depending on professional specialty and geographic region. For example, 74% (14/19) of oncologists aligned with the subgroup prioritizing physical health symptoms, while 71% (12/17) of experts from Asia aligned with the subgroup considering both physical health and psychosocial aspects. ConclusionsThis study identified key concepts to be considered in the development of a new measurement instrument to assess the self-reported health and functioning status of individuals using sf-TNPs. The findings contribute to the scientific evidence base for understanding and evaluating both the individual and public health impacts of sf-TNPs.

Abstract 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.

Abstract 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.

Background: This was a pre-market, observational, actual use study with the Tobacco Heating System (THS), a candidate modified risk tobacco product. The main goal of the study was to describe THS adoption within current adult daily smokers by replicating the usage of THS in real-world conditions with participants being able to consume cigarettes, THS, and any other nicotine-containing products (e.g., e-cigarettes, cigars, etc.) ad libitum. Methods: This study assessed self-reported stick-by-stick consumption of THS compared with the use of commercial cigarettes over six weeks. The aim of the analysis was to identify potential predictors for adoption of THS using stepwise logistic regression analysis. Results: By the end of the observational period (in Week 6), 14.6% of participants (n=965) had adopted THS meaning that THS formed 70% or more of their total tobacco consumption. The main predictors of adoption were the liking of the smell, taste, aftertaste, and ease of use of THS. The proportion of adoption was higher in participants aged 44 years and older and in Hispanic or Latino adult smokers. Additionally, adoption of THS was more likely in participants who had never attempted to quit smoking and in participants who smoked up to 10 cigarettes per day. Finally, the adoption of THS was higher in participants who consumed both regular and menthol THS compared with those who consumed only one THS variant. Conclusions: The findings suggest that the introduction of THS in the U.S. has the potential to result in adoption by current adult smokers who would otherwise continue to smoke cigarettes, and that the adoption of THS is unlikely to result in an increase of tobacco consumption. Post-marketing studies will provide further insights on THS adoption and THS use patterns to allow assessment of the impact of the THS at the individual and the overall population level.

Abstract Background Making tobacco products associated with lower risks available to smokers who would otherwise continue smoking is recognized as an important strategy towards addressing smoking-related harm. Predicting use behavior is an important major component of product risk assessment. In this context, risk perception is a possible factor driving tobacco product uptake and use. As prior to market launch real-world actual product use cannot be observed, assessing risk perception can provide predictive information. Considering the lack of suitable validated self-report instruments, the development of a new instrument was undertaken to quantify perceived risks of tobacco and nicotine-containing products by adult smokers, former smokers and never-smokers. Methods Initial items were constructed based on a literature review, focus groups and expert opinion. Data for scale formation and assessment were obtained through two successive US-based web surveys (n = 2020 and 1640 completers, respectively). Psychometric evaluation was based on Rasch Measurement Theory and Classical Test Theory. Results Psychometric evaluation supported the formation of an 18-item Perceived Health Risk scale and a 7-item Perceived Addiction Risk scale: item response option thresholds were ordered correctly for all items; item locations in each scale were spread out (coverage range 75–87%); scale reliability was supported by high person separation indices > 0.93, Cronbach’s alpha > 0.98 and Corrected Item-Total Correlations > 0.88; and no differential item functioning was present. Construct validity evaluations met expectations through inter-scale correlations and findings from known-group comparisons. Conclusions The Perceived Risk Instrument is a psychometrically robust instrument applicable for general and personal risk perception measurement, for use in different types of products (including cigarettes, nicotine replacement therapy, potential Modified Risk Tobacco Products), and for different smoking status groups (i.e., current smokers with and without intention to quit, former smokers, never smokers).

Background: This was a pre-market actual use study with the Tobacco Heating System (THS), a candidate modified risk tobacco product, conducted with adult smokers in eight cities in the United States. The main goal of the study was to describe THS adoption in a real-world setting. The aim of this analysis was to identify potential predictors for adoption of THS using stepwise logistic regression method. Methods: This actual use study was an observational study assessing self-reported stick-by-stick consumption of the THS product compared with the use of commercial cigarettes over six weeks. The study aimed at replicating the usage of THS in real-world conditions with participants being able to consume cigarettes, THS, and any other nicotine-containing products (e.g., e-cigarettes, cigars, etc.) ad libitum. Results: 14.6% of participants adopted THS, which comprised 70% or more of their total tobacco consumption by the end of the observational period (in Week 6). The main predictors of adoption were the liking of the smell, taste, aftertaste, and ease of use of THS. The proportion of adoption was higher in participants aged 44 years and older and in Hispanic or Latino adult smokers. Additionally, adoption of THS was more likely in participants who had never attempted to quit smoking and in participants who smoked up to 10 cigarettes per day. Finally, the adoption of THS was higher in participants who consumed both regular and menthol THS compared with those who consumed only one THS variant. Conclusions: The main predictors of THS adoption were positive sensory assessment and the ease of use. Socio-demographic characteristics and smoking habits appeared much less important. Post-marketing studies will provide further insights on the impact of the THS at the individual and the overall population level.

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.

Background: Several instruments are widely used for assessing dependence, craving, withdrawal symptoms, and reinforcing effects in users of tobacco- and nicotine-containing products (TNP), including the Fagerström Test for Nicotine Dependence (FTND), Questionnaire of Smoking Urges, original (QSU) and brief (QSU-b) versions; Minnesota Nicotine Withdrawal Scale, original (MNWS) and revised (MNWS-R) versions; and Cigarette Evaluation Questionnaire, original (CEQ) and modified (mCEQ) versions. Although these instruments have been translated extensively, their translations and corresponding measurement properties have not been systematically assessed. This study aimed to (1) identify the translations of these instruments for which psychometric properties have been published, (2) describe the methods used for translation, and (3) describe the measurement properties and the context in which these translations were evaluated (e.g., target population and TNP used). Methods: Embase and MEDLINE databases were systematically searched. Results: While no information could be found for the CEQ/mCEQ, several translations were available for the remaining instruments: FTND, 25; QSU and QSU-b, 4 each; QSU (12-item version), 1; MNWS, 4; and MNWS-R, 1. Cigarette smokers represented the main target population in which the validation studies were conducted. Information about the translation process was reported for 25 translations. In most cases, the properties of the translations mirrored those of the originals. Differential item functioning was explored in only one case. Conclusions: There are few publications describing the measurement properties of the translations of the FTND, QSU/QSU-b, and MNWS/MNWS-R. None of these translations have been validated for TNPs other than cigarettes, which suggests the need for greater development and validation of instruments in this area.