Abstract
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.
Highlights
Many stakeholders have recognized that there is a risk continuum for tobacco and nicotine products (TNPs)[1,2]
List of abbreviations ABOUT: Assessment of Behavioral OUtcomes related to Tobacco and nicotine products; FDA: U.S Food and Drug Administration; ICF: International Classification of Functioning, Disability, and Health; modified Cigarette Evaluation Questionnaire (mCEQ): Modified Cigarette Evaluation Questionnaire modified-risk tobacco products (MRTPs): Modified risk tobacco product; patient-reported outcome (PRO): Patient-reported outcomes; PROQOLID: Patient-Reported Outcome and Quality of Life Instruments Database; RMM: Rasch measurement methods; TA: Translatability assessment; TNP: Tobacco and nicotine product; WHO: World Health Organization
Tobacco harm reduction is an approach recognized by the U.S Food and Drug Administration (FDA), the Institute of Medicine, and the World Health Organization (WHO) as part of a solution to more rapidly reduce the burden of preventable deaths and smoking-related diseases[3,5,6,7]
Summary
Many stakeholders have recognized that there is a risk continuum for tobacco and nicotine products (TNPs)[1,2]. In the U.S, this has given rise to a regulatory framework for manufacturers to market modified-risk tobacco products (MRTPs), defined by the FDA as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”[8]. 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. This communication: (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUTTM Toolbox, (2) presents a summary of the high-priority tobacco-related domains that are currently covered in the ABOUTTM 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 Invited Reviewers version 1
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have