About Toolbox™

These instruments are designed using best measurement and development practices, to be fit-for-purpose and to accurately compare combustible and non-combustible products.

The ABOUT™ Toolbox instruments are distributed by Mapi Research Trust on PMI's behalf and made available to the wider scientific community through the ePROVIDE™ platform.

You can learn more about the ABOUT™ toolbox by accessing the recorded webinar "Introducing the ABOUT™ – Toolbox: A Measurement Innovation in Tobacco Regulatory Research" here. Note that you should register to get access to the recorded webinar.

By sharing the ABOUT™ Toolbox, PMI provides researchers with access to instruments that are:

• Developed and validated with state-of-the-art methods, straightforward to implement, and easy to interpret.
• Relevant to the whole spectrum of tobacco and nicotine-containing products.
• Designed to facilitate comparisons of perception and behaviour data across academic, industry and public health research communities.

The instrument in a nutshell

The measurement of dependence on tobacco and/or nicotine-containing products (TNPs) has primarily focused on assessing product-specific dependence (notably cigarette dependence) rather than overall dependence associated with the use of one or more TNPs. Considering the range of TNPs currently available, and the diversity of product use behaviors, the ABOUT™ - Dependence was developed to provide a measure of perceived psychological dependence associated with the use of different TNPs and across exclusive and multiple TNPs users.

The initial validation of the ABOUT™ - Dependence was conducted in a diverse population of TNP users. This included exclusive and multiple TNP users across different products that contain tobacco (e.g., cigarettes, cigar/cigarillos, smokeless tobacco, waterpipe, and pipe), as well as products that contain nicotine but no tobacco (e.g., e-cigarettes). The broad applicability of the instrument to different product types and product use behaviors increases the applicability of the instrument to any other existing or novel TNPs.

The instrument in detail

The ABOUT™ - Dependence is based on an underlying conceptual framework developed from expert opinion, a comprehensive literature review, and concept elicitation interviews with different TNP users. The interviews with TNP users also included a cognitive debriefing aspect to review understanding of the items, and appropriateness of the response options.

Psychometric evaluation of the draft version of the instrument led to a 12-item final version of the instrument consisting of three main perceived dependence domains: 1) Extent of use (two items), refers to the timing of use (time to first product use, time from last product use to going to bed), 2) Signs and symptoms (five items) captures the feelings and experience of the symptoms of perceived dependence, and 3) Behavioral impact (five items) captures the behavioral aspects of perceived dependence and impact on daily activities.

The ABOUT™ - Dependence has been developed to be electronic/paper version self-administered instrument and time of administration is less than 5 minutes. Depending on the research question and focus of interest, the instrument can be scored and interpreted using separate scores for each domain and/or total composite scores across the three domains in the instrument.

Product experience encompasses a range of self-reported expressions of an individual’s experience using a TNP and is a key predictive measure of short-term preference and long-term TNP use (O'Connor, 2018). The modified Cigarette Evaluation Questionnaire (mCEQ) has been endorsed by regulatory and public health bodies to use in the context of MRTP assessment (Hanson, 2009). The ABOUT–Product Experience includes three multi-item scales (satisfaction, psychological reward, wversion) and two single-item scales (craving reduction and enjoyment of respiratory tract sensation) arising from an adaptation and rewording of the mCEQ (Cappelleri, 2007) and the Product Evaluation Scale (Hatsukami 2013).

Psychometric testing and validation have been carried out for the use of the measure to assess a variety of TNPs (e.g., e-cigarettes, cigars/cigarillos, smokeless products, heated tobacco products) using a 7 days recall period.

The ABOUT–Product Experience will be soon available in eProvide!

To date, there is no consensus on a standardized tool to measure consumption of different tobacco and nicotine-containing products (TNPs). Moreover, very few longitudinal tools exist which adequately capture the time-varying and complex nature of TNP use patterns. The development of the ABOUT™ - Tobacco Exposure is currently ongoing to enable the assessment of cumulative exposure to TNPs with the following requirements:

• To be used at multiple times longitudinally,
• To be brief and easy to complete in different administration mode,
• To capture key variables of Frequency, Quantity, Duration (including initiation and cessation) of different TNPs,
• To allow derivation of use patterns according to pre-defined user definitions,
• To ensure stability of the measure in test-retest,
• To ensure applicability cross-nationally.

The development of the ABOUT™ - Tobacco Exposure leverages content from an already published questionnaire, the Smoking Questionnaire, that provides a core set of questions that cover the major dimensions of cigarette smoking and demonstrates good test-retest reliability (Weitkunat, 2013; Sponsiello-Wang, 2017).

Health and functioning is a relevant dimension for the evaluation of Reduced Risk Product’s (RRPs) impact on public health and requires further investigation. To date, no established smoking-related quality of life measures have been shown to be sensitive enough to detect changes in health and functioning in otherwise healthy smokers who switch to RRPs.

Currently, efforts are ongoing to develop a new outcome measure for inclusion in the ABOUT™ Toolbox that would accurately reflect the health and functioning status of individuals who use TNPs, with a particular focus on healthy adult smokers who switch to RRPs. The goal of the ABOUT™ - Health & Functioning is to develop a sensitive self-report measure that will accurately assess relevant dimensions of health and functioning impacted by TNP use.

The measure’s development is underpinned by theoretical conceptual frameworks including, but not limited to, the WHO’s International Classification of Functioning, Disability (WHO, 2001), and Health (ICF) and the Revised Wilson and Cleary Model for Health-Related Quality of Life (Ferrans, 2005).

The preparatory phase of the development included a scoping literature review, secondary analyses of existing qualitative focus groups and individual interviews, and convening of an expert panel and led to the identification of 69 relevant concepts. 33 existing health and functioning related measures were also retrieved to inform item generation and item banking.

The current phase includes qualitative concept elicitation studies in Germany, Japan and the US, to identify relevant concepts related to health and functioning that matter to users of smoke-free products (e.g. IQOS® users). A global Delphi panel survey is also organized with international Health care providers to ensure the clinical and cross-cultural relevance of the health and functioning concepts from a clinician perspective.

Next steps include the development of the measurement model, generation of items to best represent the different domains of the model, evaluation of the content validity of the draft items through cognitive debriefing, and assessment of the psychometric properties of newly generated ABOUT™ - Health and Functioning items with the intent to create calibrated item banks that could be used either as fixed forms or using computer adaptive testing (CAT). CAT is an innovative solution used to individualize and shorten existing self-report instruments and maintain reliable estimates for scores (Linacre 2000). As opposed to presenting all items in a fixed order, a CAT uses an algorithm to select which item will be presented to the participant next. As a result, the assessment is tailored to each individual participant.

Data regarding the preparatory phase have been presented at two international scientific conferences.

Related publications

• Spies E., et al. The development of a new measurement instrument to assess health and functioning among tobacco and nicotine product users: the preparatory phase. Poster presentation at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting, New Orleans, LA, USA (May 2019).