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In tobacco regulatory research, risk perceptions are defined as the subjective judgments about the potential harms to health from using tobacco and nicotine-containing products. It is an important construct that can predict future use behaviour such as experimentation, cessation, as well as switching to other tobacco- and nicotine-containing products. In the context of tobacco harm reduction strategies, risk perceptions are often evaluated prior to product commercialization, to ensure that the product risk communication materials are an accurate, non-misleading, and scientifically substantiated reflection of the product characteristics. This allows current adult smokers to understand the risks and benefits of the product compared to other tobacco products, without encouraging non-smokers and ex-smokers to initiate or reinitiate tobacco use. Risk perception is also evaluated in a post-market setting to evaluate the trends of risk perception and thus potentially use behaviour over time.

Risk perception assessments rely exclusively on consumer-reported outcome measures (CROM), and this requires reliable and valid measures that ensure legitimate comparison (from a measurement standpoint) between different tobacco and nicotine products and different user (and non-user) groups. In the last few years, there have been numerous advances in the measurement of risk perception, including methodological considerations in using such measures in regulatory applications. In this workshop, we will use the case study of the specific development of the ABOUT™—Perceived Risk to illustrate some of the key measurement challenges and unique opportunities this domain of perception offers to strengthen CROM-related science.

The Perceived Risk Continuum for Tobacco and Nicotine-Containing Products – Does Measurement Matter?

Many stakeholders have recognized that there is a risk continuum for tobacco and nicotine-containing products (TNPs), which denotes the impact of tobacco use on human health at the individual and population levels. On this continuum, combustible products, cigarettes in particular, present the highest risk, because burning tobacco creates high levels of the harmful and potentially harmful constituents implicated in the development of smoking-related diseases. Cessation is at the lowest and other end of the continuum, as quitting is the best way for smokers to reduce their risk. Alternative non-combustible TNPs that avoid combustion lie somewhere between these anchoring points of the continuum. While this risk continuum is mainly built on objective health-related outcomes, risks of TNP use as perceived by users and non-users are also of high importance to understand the public health impact of a non-combustible product as it can predict future use behaviour. In this presentation we will summarize the current thinking on the important considerations for assessing risk perceptions in applied contexts, and will describe some measurement criteria derived from modern psychometrics that may be important to consider to establish a perceived risk continuum for tobacco and nicotine products.

Overview of the ABOUT™—Perceived Risk Development and Evolution

The ABOUT™—Perceived Risk is a self-report instrument, developed by Philip Morris Products S.A., designed to assess perceived risks associated with the use of a wide range of tobacco- and/or nicotine-containing products (TNP), such as cigarettes, e-cigarettes, smokeless tobacco, and heated tobacco products, as well as perceived risk associated with the use of nicotine replacement therapies (NRT) or remaining risks after smoking cessation. In this presentation a brief history of the development and evaluation of the ABOUT™—Perceived Risk will be presented, starting with the original conceptual framework developed on the basis of qualitative studies, literature review, and input from experts to the initial psychometric validation of two multi-item scales for Perceived Health Risk and Addiction Risk, respectively, and three single items for “harm to others.” To keep the instrument fit-for-purpose and to adapt to a growing population of dual and poly TNP users, further cognitive debriefing interviews and quantitative studies were conducted to validate 1) additional scales (Social and Practical Risk), 2) new versions of products to be assessed (current use of two or more TNPs; remaining risk after quitting all tobacco use), and 3) a short form (9-items) of the Perceived Health Risk scale. As for the original instrument edition, the new edition including all the updates to the instrument will be made available through PROQOLID™.

Understanding of the Mechanisms Underlying Perception of Risk

Typically, the psychometric scale validation is based on various statistical (i.e., quantitative) methods on the one hand and content-related, usually qualitative, considerations on the other. Both approaches are essential but not linked. While statistical relationships between scores determine whether items behave as expected, it is content validity that ultimately provides evidence that we are measuring what we claim to be measuring (i.e., risk perceptions). A measurement mechanism for perceived risk aims at linking qualitative evidence and content validity by specifying an explanatory model of risk. Risk is generally defined as a function of the probability of an outcome and its utility, which is typically negative.

It can be shown that perceptions of probability and negative utility of the health conditions included in the 9-item Perceived Health Risk scale short form of the ABOUT™—Perceived Risk significantly explain psychometric properties of the items and the participants’ level of perceived risk. This not only strengthens the validity of the scale by providing evidence that the ABOUT™—Perceived Risk actually measures perceived risk.It also allows insight into how probability and negative utility contribute to the perceived risk of individual health conditions.

Evolution of Risk Perception of IQOS™ Over Time: Evidence from PMI’s Post-Market Cross-Sectional (PMX) Surveys

Risk perception (RP) is a key factor influencing adult smokers’ decision to transition to smoke-free tobacco and nicotine products (TNP), in addition to being a critical factor that could limit relapse among TNP users who switched away from cigarettes. PMI post-market cross-sectional surveys have been monitoring changes in the health RP of a novel tobacco heating system commercialized under IQOS™), relative to cigarette smoking, among current IQOS™ users in several countries. Our surveys demonstrate that RP is an evolving construct that changes over time and may be influenced by various factors including the availability of information on the product’s risks and benefits. Regular surveillance of the RP of novel TNPs is warranted to ensure that adult smokers who would otherwise continue to smoke and adult TNP users who switched away from cigarettes receive adequate communications on the relative risks of novel TNPs.