ABOUT Health & Functioning

To assess the perception and behavior of adults who may use PMI’s smoke-free products we built the ABOUT Toolbox – a robust portfolio of self-report instruments, which support our regulatory submissions and MRTP applications. This article outlines the latest instrument in the Toolbox which focuses on measuring the perceived health status of adult smokers who switch to our smoke-free products. The ABOUT Toolbox team is Esther Afolalu, Emilie Clerc, and Christelle Chrea. Special thanks to our intern Giulia Penone.

 

How we assess behavioral outcomes related to tobacco and nicotine products

The number of individuals switching from cigarette smoking to using smoke-free Tobacco and Nicotine-Containing Products (TNPs) is growing. Existing self-reporting measures for evaluating perceived health and quality of life are often not sensitive enough to provide a complete picture of the situation and assess impact of TNPs on the perceived health and functioning status of users.¹

For this reason, since 2012, we have been working on new outcome measures to specifically assess people’s perceptions, attitudes, and behaviors towards smoke-free products in a scientifically robust manner. This is the purpose for which the ABOUT Toolbox has been created: to evaluate and assess the public health impact of tobacco harm reduction strategies on consumer perception and behavior. The ABOUT Toolbox instruments are relevant to the whole spectrum of TNPs and they are designed using best measurement and development practices in order to facilitate the comparison of perception and behavior data across academic, industry, and public health research communities.

 

Developing a new outcome measure to assess the impact of tobacco and nicotine-containing products on health and functioning

Aiming to assess the impact of TNPs on consumers’ health and functioning, we strive to build one of the five key priority domains included in the ABOUT Toolbox (as displayed to the right) with a precise purpose. Since February 2018, we have worked on the Health and Functioning instrument, aiming to make it a comprehensive tool for the evaluation of smoke-free products’ impact on public health.

The Health and Functioning instrument is currently being developed to accurately reflect the health status of individuals who use TNPs, with a particular focus on healthy adult smokers who switch to smoke-free products.

 

Theoretical framework and main development phases

To reach this goal while remaining scientifically robust, the instruments development has been underpinned by theoretical conceptual frameworks from health authorities such as: WHO’s International Classification of Functioning, Disability,² and Health (ICF); the Revised Wilson and Cleary Model for Health-Related Quality of Life;³ and the US Food and Drug Administration’s (FDA) Guidance on Patient-Reported Outcome (PRO) Measures.⁴ Based on these and other frameworks, we organized the development process of the new self-reporting measures into three main phases:

 

A. PREPARATION

This phase incorporates background research and consultations with subject matter experts to guide the selection of methodologies for identifying relevant concepts in this context. This phase started in early 2018 with a comprehensive literature review of 97 existing publications, aiming at identifying both the positive and negative impacts that TNP use could have on users’ health and functioning. Later, we reanalyzed data from focus groups on risk perception and individual interviews on perceived dependence in TNP users, in order to extract meaningful preliminary consumer insights on health and functioning. Additionally, we brought together a panel of six experts, combining expertise in tobacco science, PRO development, FDA regulatory science, and health economics to provide guidance in all phases of development of the self-reported measure. In the preparatory phase, they helped in identifying the main concepts across key domains* impacted by TNP use to inform item generation and banking.

* These domains included core health and functioning domains (physical health symptoms [e.g., oral and respiratory], general physical appearance and hygiene, functional status [physical, sexual, cognitive, emotional, and social functioning], and general health perceptions) and conceptually-related domains (worry about health risks of using TNPs, fear of withdrawal symptoms, and perceived benefits of TNP use)⁵.

 

B. DEVELOPMENT

Carried out in 2019-2020, this aimed to implement mixed methods (qualitative and quantitative methodologies) to identify and develop suitable items to capture the relevant dimensions in this context. To do so, three qualitative studies have been conducted to elicit health- and functioning-related concepts in adult cigarette smokers who have switched to alternative smoke-free TNPs.

First, we conducted some longitudinal interviews (with 45 participants completing the study) in an Exercise Capacity Clinical Study in Germany, with a sample of participants made by adult users who switched to EHTS, continued cigarette use, or abstained with or without a combined exercise training program.

Second, we carried out individual interviews for exploring changes in health and functioning in Japan with a sample of 35 Japanese healthy adults who switched from cigarette smoking to using EHTS (exclusively or dual use with cigarettes) and other smoke-free products.

Third, we conducted ten focus groups within a US population of adult smokers who switched from smoking cigarettes to exclusively using e-cigarettes, smokeless tobacco, or who used nicotine-replacement therapies (exclusively or dual use with cigarettes). Following these three rounds of qualitative studies, we recruited some international healthcare providers to organize a global Delphi panel survey which ensured the clinical and cross-cultural relevance of the highlighted health and functioning concepts.

 

C. VALIDATION

The phase is still ongoing and expected to be completed in 2021. During this stage, we will conduct cognitive debriefing interviews to evaluate content validity, appropriateness, and understanding of draft items. Finally, we will field-test the pilot instrument to assess the reliability, validity and psychometric properties of the ABOUT Health and Functioning instruments across a range of TNPs and use types.

 

What we expect to achieve with the ABOUT Health and Functioning instrument

By following reported best measurement practices and processes, the major aim of developing a new set of measures is to enable and facilitate an accurate assessment of TNP impact on individual health and quality of life. Moreover, we would also like to highlight the relevant personal and everyday dimensions that are impacted by TNP use, especially those that are more susceptible to change or remain stable when switching from cigarettes to TNP alternatives. By making the ABOUT Toolbox Health and Functioning instrument available to the tobacco research and public health communities, people can rapidly and properly expand their knowledge base on the topic. Furthermore, we pursue the goals of supporting consumer perception and behavior, enabling public health and regulatory communities to make better-informed decisions for future regulation of TNPs, and enhancing surveillance activities associated with the impact of TNPs on population health.

 

References: 

1. J. E. R. Ware et al. Evaluation of smoking-specific and generic quality of life measures in current and former smokers in Germany and the United States. Health Qual Life Outcomes 13, 128 (2015). DOI:10.1186/s12955-015-0316-3.

2. WHO, International Classification of Functioning, Disability and Health (ICF) (2001). (Link)

3. C. E. Ferrans et al. Conceptual Model of Health-Related Quality of Life. J Nurs Scholarsh 37, 336–342 (2005). DOI: 10.1111/j.1547-5069.2005.00058.x.

4. FDA (Food and Drug Administration), Guidance for industry - Patient-reported outcome measures: use in medical product development to support labeling claims (2009). (Link)

5. E. Spies et al. Development of a new outcome measure to assess the impact of reduced-risk tobacco- and nicotine-containing products on health and functioning: a comprehensive literature search; Presented at ISOQOL, 24-27, Dublin (2018). (Link)