Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT Toolbox initiative
Assessing the full potential of reduced risk products (RRP), for individual users and the population as a whole, requires the assessment of consumer perception and behavior associated with tobacco and nicotine products (TNP) with different exposure and risk profiles. In this context, psychometrically sound self-report instruments are needed to allow accurate comparison between RRPs and other tobacco and nicotine-containing products. 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”, fit-for-purpose, reliable, and valid instruments are now being applied to tobacco regulatory research. The present paper presents the ABOUT Toolbox (Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) initiative, resulting from an ongoing collaborative effort in close partnership with scientific experts from academic and commercial organizations with expertise in the fields of nicotine addiction, motivational aspects of consumer perception, and relevant areas on approaches to measurement (e.g. Patient Reported Outcomes, cross-cultural adaptation, psychometrics, regulatory submissions). This communication (1) describes the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT Toolbox and (2) presents a summary of the high-priority, tobacco-related domains (e.g. perceived risks, dependence, product use history) that are currently covered in the ABOUT Toolbox. 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 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 smoking-related disease.