The ABOUT™ Toolbox: Health, Risk Perception, Dependence, Tobacco Exposure, and Product Experience

What is the ABOUT™ Toolbox?

The ABOUT™ (Assessment of Behavioral OUtcomes related to Tobacco and nicotine products) Toolbox is a portfolio of CROM, where data are collected from individuals by self-report questionnaires or surveys. They allow researchers to assess attitudes, perceptions, and behaviors toward TNPs in a scientific and robust manner. The primary goal of the ABOUT™ Toolbox is to accurately compare combustible and smoke-free products and facilitate comparisons of perception and behavior data across academic, industry, and public health research communities.

The toolbox is comprised of five separate instruments:

• ABOUT™ - Perceived Risk
• ABOUT™ - Dependence
• ABOUT™ - Product Experience
• ABOUT™ - Tobacco Exposure
• ABOUT™ - Health and Functioning

These instruments cover a broad spectrum of TNP types and are intended to be adaptable across various user status and cultural contexts, delivering a versatile measurement system.

 

The role of the ABOUT™ Toolbox in a regulatory context

The Toolbox is developed in accordance with the 2012 draft guidance for modified risk tobacco product (MRTP) applications issued by the U.S. Food and Drug Administration’s (FDA’s) Center for Tobacco Products. In line with this guidance, consumer perception and behavior assessments are key components in assessing the public health impact of tobacco harm reduction strategies.

Valid and reliable self-report measures are needed to assess consumer responses to MRTPs in comparison with other commercially available TNPs. However, the field of tobacco regulatory research lacks specifically developed measures for standardization and harmonization across different studies and products. The ABOUT™ Toolbox is designed to address this need. Extensive validation has confirmed the Toolbox’s reliability and effectiveness across different research and regulatory settings.

 

Why is behavioral and consumer science important in product development and assessment?

PMI conducts perception and behavior research to predict consumer behaviors and perceptions when designing new products. This research is integrated with product development to ensure that product innovations enhance user experience and encourage complete switching from cigarettes to smoke-free products while discouraging uptake from unintended audiences.

Our perception and behavior research also assesses the impact of smoke-free products on consumers, for example to measure whether current adult smokers who would otherwise continue to smoke are switching to smoke-free products and whether nonsmokers and former smokers recognize that the product is not for them.

 

How are the tools developed?

The ABOUT™ Toolbox has been developed using best measurement development practices and reference to guidelines such as the FDA’s “Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims” and the best practice guidelines and technical reports developed within the Cooperation Center for Scientific Research Relative to Tobacco (CORESTA). The development process typically includes the following major components:

1. Generation of a conceptual framework

Development begins with the generation of a conceptual framework, supported by data from literature reviews, consumer input, and input from subject matter experts and key opinion leaders in fields such as nicotine addiction, consumer perception, and approaches to measurement.

2. Evaluation of content validity

Cognitive debriefing interviews are conducted to determine whether the content (items, response options, recall periods, and instructions) is appropriate, relevant, comprehensive, and understandable to the target population.

3. Evaluation of psychometric properties

The psychometric assessment of most of the ABOUT™ instruments is based on the use of Rasch measurement methods (RMM) and Classical Test Theory (CTT) to check and confirm reliability, validity, measurement properties, and scoring rules.

4. Cross-cultural equivalence 

The instruments included in the ABOUT™ Toolbox are designed for use in different countries and languages. They follow a thorough linguistic validation process consisting of forward and backward translations and qualitative cognitive debriefing interviews with participants in the targeted language to ensure that the translations are culturally adapted and understood as intended.

5. Appropriate access and use of the validated instruments

Once the instruments (both original and translations) are fully developed and validated, the studies supporting their development and validation are disseminated in peer-reviewed publications and the instruments are made publicly available with instructions for their use through the Patient-Reported Outcome and Quality of Life Instruments Database (PROQOLID™) managed by Mapi Research Trust and part of the ePROVIDE™ web platform.

 

The ABOUT™ Toolbox instruments

The five separate ABOUT™ Toolbox instruments focus on different priority areas. The toolbox provides researchers with access to instruments that are developed and validated with state-of-the-art methods, straightforward to implement, and easy to interpret.

ABOUT™ – Perceived Risk: The role of risk perception in tobacco harm reduction

The ABOUT™ – Perceived Risk instrument is designed to measure consumers' perceptions of risks associated with the use of various TNPs, as well as perceived risks related to TNP use cessation.

How individuals perceive the risks associated with TNPs affects their decisions to switch to smoke-free products, quit, or continue using cigarettes. Understanding perceptions of both absolute risk (e.g., specific health risks like heart disease) and relative risk (e.g., differences between products) helps regulators evaluate consumer comprehension of reduced-risk and reduced-exposure product claims.

The instrument is intended to gather meaningful insight on five areas relevant to TNP use:

• Perceived health risks (long and short term)
• Perceived addiction risks
• Perceived harm to others
• Practical risk 
• Social risk  

The instrument has been developed and validated using concept elicitation and cognitive debriefing interviews with TNP users and modern psychometric techniques in cross-cultural studies. It has been used by PMI in studies submitted as part of premarket tobacco product applications (PMTA) and MRTP to highlight the importance of accurate risk communication and ensure consumers are informed of and accurately perceive the risks of the Tobacco Heating System (THS) in relation to cigarettes.

It has also been used by PMI in cross-sectional surveys estimating the prevalence of tobacco product use and tobacco use patterns in adults in Germany, Italy, and Japan, and in research to assess the varying perceptions of health risks associated with the use of THS and cigarettes.

ABOUT™ – Perceived Risk can be accessed here.

ABOUT™ – Dependence: Measuring perceived dependence to tobacco and nicotine products

ABOUT™ – Dependence was developed to assess perceived dependence associated with TNP use. It focuses on providing insights into how perceived dependence affects users' experiences and behaviors. This information is valuable for developing effective harm reduction strategies and to assess product abuse liability potential (defined by the FDA as “the likelihood that individuals will develop physical and/or psychological dependence on the tobacco product”).

This instrument was specifically designed to measure and compare perceived psychological dependence related to both cigarettes and smoke-free products.

The ABOUT™ – Dependence questionnaire is organized into three domains:

• Extent of Use: Evaluates the timing and urgency of TNP use, for example, time to first TNP use upon waking up.
• Behavioral Impact: Assesses how perceived dependence influences daily life, including social interactions and personal activities.
• Signs and Symptoms: Identifies physical and psychological symptoms associated with perceived dependence experienced by TNP users, such as urges and cravings.

This instrument was developed through literature reviews, consultation with experts, and qualitative research, including interviews with TNP users. Validation with rigorous psychometric testing has confirmed the internal consistency, test-retest reliability, convergent validity, known-groups validity, and scoring structure of the instrument.

Applicability has recently been extended to THS, and it was administered as an exploratory endpoint to enhance understanding of how perceived dependence may change after switching from cigarettes to THS. Future research will focus on longitudinal studies to assess perceived dependence over time and additional cross-validation across various TNP types, diverse populations, and cultural contexts.

ABOUT™ – Dependence can be accessed here.

ABOUT™ – Product Experience: Measuring individual’s experience of using TNPs

The ABOUT™ – Product Experience instrument is designed to capture self-reported user experiences (positive and negative reinforcing effects) with TNPs, providing valuable insights into both short-term preferences and potential long-term usage patterns. The instrument was adapted from established measures like the modified Cigarette Evaluation Questionnaire (mCEQ) and Product Evaluation Scale. It was further validated to ensure it accurately reflects experiences with different types of tobacco and nicotine products, especially smoke-free products, and rigorous testing has confirmed its effectiveness in capturing meaningful data on experiences with these products. The instrument evaluates various dimensions of user experience, including satisfaction, psychological reward aversion, enjoyment of respiratory tract/mouth sensation, and sensation of craving relief.

PMI has administered this tool in clinical studies on THS, where it was used to assess subjective effects of product use. Results indicated that, when switching from cigarettes to THS, adult smokers find THS acceptable and satisfying.

ABOUT™ – Tobacco Exposure: Measuring use of TNPs

This instrument was developed and validated to provide a standardized measure of the use and exposure to TNPs. Currently, there are limited standardized tools that effectively capture the complex and evolving patterns of TNP use beyond cigarettes. The ABOUT™ – Tobacco Exposure instrument is designed to address this gap.

Building on the existing Smoking Questionnaire, the ABOUT™ – Tobacco Exposure tool aims to standardize the measurement of tobacco and nicotine use. By providing a consistent and reliable basis for assessing cumulative exposure, it enables more accurate tracking of use patterns and offers better insights into use behaviors and impacts of different TNPs.

The instrument captures key variables including frequency, quantity, intensity, and duration of current and past use, exclusive and multiple product use, lifetime exposure, initiation, cessation, duration of use, duration of interruption, product characteristics (e.g., brands and flavors), and context of use.

This tool incorporates several key requirements to ensure effectiveness and applicability for use in TNP research. These include:

• Consistency over repeated use (including stability in test-retest results to ensure that the measure remains reliable over time and across different contexts).
• Modularity to enable assessment of variables of interest for different TNPs.
• Accommodation of standardized and predefined user definitions.
• Applicability across various national contexts, making it useful for global research.
• Easy to complete across different administration modes.

The instrument is administered in a wide range of PMI’s studies. For example, in screening and eligibility checks, to categorize participants based on TNP use characteristics, to quantify TNP use during studies, to assess adherence to study arms involving TNP use, and to determine use of TNPs over time during longitudinal follow-up assessments. Work is ongoing to expand and assess the applicability of the instrument for better evaluating the exposure and use of TNPs over time (e.g., retrospectively and through proxy reports), in the context of real-world studies.

ABOUT™ – Health and Functioning

The ABOUT™ – Health and Functioning instrument is designed to accurately reflect the self-reported health and functioning status of individuals who use TNPs and assess relevant dimensions of health and functioning status impacted by TNP use and switch from cigarettes to smoke-free products.

Health and functioning status is a relevant dimension for the evaluation of the impact of smoke-free products on individual and population health and requires further investigation. Beyond existing smoking-related, Quality of Life measures, we needed to establish measures that fit for purpose and are sensitive enough to detect even the most subtle changes in perceived health and functioning status in those who switch from cigarette smoking to using smoke-free products.

The preparatory phase of the development of this instrument included a scoping literature review, secondary analyses of existing qualitative focus groups, and individual interviews and convening of an expert panel. This led to the identification of 69 relevant health and functioning concepts. Thirty-three existing health and functioning-related measures were also retrieved for item mapping and to inform item generation of the instrument.

Development and item generation of the instrument has included qualitative concept elicitation studies in Germany, Japan, and the U.S. These were conducted to identify relevant concepts related to health and functioning status that matter to adult users of smoke-free products on switching from cigarette smoking.

A global Delphi panel survey was also organized to identify the most important concepts to measure when evaluating health and functioning status associated with a switch from smoking cigarettes to using smoke-free products and to ensure the clinical and cross-cultural relevance of the instrument.

The validation phase for the ABOUT™ – Health and Functioning measure included mixed-methods research. Qualitative cognitive debriefing interviews were conducted with TNP users in the U.K. and U.S., to assess understanding and content validity of the instrument. A quantitative survey involving users of TNPs (cigarettes, e-cigarettes, heated tobacco products, smokeless tobacco products, nicotine replacement therapies) in the U.S., Japan, Germany, Italy, and Russia was conducted to assess its psychometric properties, reliability, validity, and provide supportive evidence for its key measurement properties.

The instrument now comprises 10 scales covering various health and functioning concepts (e.g., lung health and breathing, oral health, social functioning). Future work will focus on enhancing its applicability, administration, and refining its measurement properties through further data collection, particularly in longitudinal studies, to evaluate the impact of switching from cigarettes to smoke-free product use on health and functioning status over time.

 

The future of ABOUT™ Toolbox

The ABOUT Toolbox will continue to evolve to address emerging trends and challenges in tobacco harm reduction. This will be accomplished through ongoing updates to incorporate the latest scientific findings, ensuring that the toolbox remains relevant and effective. Future developments will focus on enhancing the adaptability of the toolbox to new TNPs, refining measurement techniques, and expanding its global applicability.