Introducing the ABOUT™ – Toolbox: A Measurement Innovation in Tobacco Regulatory Research

Drug Safety, Life Sciences,
  • Wednesday, November 13, 2019

 

In alignment with the US Food and Drug Administration (FDA)’s draft guidance on modified risk tobacco products (MRTP), consumer perception and behavior assessments are key components of evaluating the full public health impact of tobacco harm reduction. Valid and reliable self-report measures are needed to assess consumer responses to MRTP in comparison with other commercially available tobacco and nicotine-containing products. This webinar will present an ongoing collaborative effort to develop fit-for-purpose measurement instruments to enhance the scientific framework of harm reduction. This new initiative has resulted in the creation of the ABOUT™ Toolbox (Assessment of Behavioral OUtcomes related to Tobacco and nicotine products).

In this free webinar, attendees will learn about the ABOUT™–Toolbox, a portfolio of self-report instruments to assess perceptions, attitudes, and behaviors in consumers of tobacco and nicotine-containing products. The portfolio includes five different measurement instruments assessing perceived risk, use history, product experience, perceived dependence, and health and functioning.

This webinar will feature four speakers:

Catherine Acquadro will present the rationale behind the development of the toolbox and a brief description of each measurement instrument assessing five high-priority tobacco-related domains, i.e., perceived risk, use history, product experience, perceived dependence, and health and functioning. Details of how the measurement instruments are made accessible to the scientific community will be provided.

Christelle Chrea will present the regulatory context in which the ABOUT™–Perceived Risk instrument has been developed and how it was used in the marketing order process of IQOS (a heated tobacco product) by the US FDA.

Stefan Cano and Thomas Salzberger will describe the methodological steps followed for the development and validation of the measurement instruments included in the ABOUT™ Toolbox, using as examples the ABOUT™–Perceived Risk and the ABOUT™–Dependence instruments.

* Reduced-risk products (RRPs) is the term Philip Morris uses to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to those products versus continued smoking.

Speakers

Catherine Acquadro, MD, Head of Thought Leadership, Mapi Research Trust

Innovation and communication have been the cornerstones of Catherine Aacquadro’s career. In 1991, she created the first means of communication about quality of life research, i.e., the Quality of Life Newsletter, now the Patient-Reported Outcomes (PRO) Newsletter. She has launched Mapi’s linguistic validation (LV) activities in the early 1990s with her involvement in the International Quality of Life Assessment (IQOLA) Project with John Ware. She has coordinated the European Regulatory Issues on Quality of Life Assessment (ERIQA) project for the recognition of PROs in the evaluation of medicinal products, as well as the PRO Harmonization Group in collaboration with the FDA.She also participated in activities which led to the development and publication of the FDA guidance on PRO measures in 2009. Dr. Acquadro created the Cochrane PRO Methods Group of which she has been co-convenor for several years with Donald Patrick and Gordon Guyatt. She also initiated the development of Mapi Research Trust databases such as PROQOLID, PROLABELS and PROINSIGHTS. She is now involved in the development of a consortium approach for the development, validation, use and access of consumer-reported outcome measures for tobacco research.

Message Presenter

Christelle Chrea, PhD, Behavioral Epidemiology Manager, Philip Morris International (PMI)

Christelle Chrea manages the behavioral epidemiology team at Philip Morris International (PMI). She has over 15 years of experience in managing consumer research projects in multicultural and multidisciplinary teams for different industries such as car, fragrances, wine, cosmetics and now reduced-risk tobacco products (RRP)*. In her current role, she leads a team of scientists to conceive the strategy, plan and activities to advance translational knowledge on PMI reduced-risk products (RRP) perceptions and related behaviors – activities which led to the development and deployment of the ABOUT™ Toolbox.

Message Presenter
http://Stefan%20Cano,%20Modus%20Outcomes

Stefan Cano, PhD, CPsychol, AFBPsS, Co-Founder and Chief Scientific Officer, Modus Outcomes

Stefan Cano is co-founder and chief scientific officer at Modus Outcomes, a company that provides specialized consulting services to biopharmaceutical, diagnostic and device companies about the evaluation of the benefit and therapeutic value of medical products using patient-centred outcome (PCO) measures. Before starting at Modus Outcomes in 2014, Stefan spent 20 years working as an academic and industry consultant researcher in PCO measurement across a range of clinical and surgical disciplines (peer-review publication H-Index 51). Having previously worked extensively in qualitative and quantitative research projects, Stefan’s main area of interest is in developing, applying and improving mixed methods psychometric research in clinical studies and therapeutic trials. He is especially interested in maximizing the interpretability of existing and new PCO measures. Stefan is also co-developer of Q-Portfolio Patient-Reported Outcome (PRO) measures for cosmetic, plastic, reconstructive and cancer surgery called the BREAST-Q©, FACE-Q©, BODY-Q© and CLEFT-Q©, which have been used internationally in clinical research, clinical trials, clinical practice, clinical guidance, quality improvement initiatives, national registries, national audit and normative data.

Message Presenter
http://Dr.%20Thomas%20Salzberger,%20WU%20Vienna

Dr. Thomas Salzberger, Senior Lecturer, Institute for Statistics and Mathematics, Institute for Marketing Management, WU Vienna

Dr. Thomas Salzberger is a senior lecturer at the Institute for Statistics and Mathematics and the Institute for Marketing Management at the WU Vienna (Vienna University of Economics and Business). He also teaches at various universities of applied science and works as a consultant. He earned a doctorate in 1998 on the comparison of traditional test theory and Rasch measurement for assessing cross-cultural measurement equivalence. In 2008, he completed the habilitation on an alternative framework for the measurement of latent variables in marketing research. Besides research in consumer behaviour and international marketing, he focuses on the application of the Rasch model for measurement in the social sciences and the fundamental underpinnings of the model.

His work has been published in the Journal of Business Research, European Journal of Marketing, Frontiers in Quantitative Psychology and Measurement, Advances in International Marketing, International Marketing Review and Journal of Advertising. He is also in charge of the Matilda Bay Cub (MBC) discussion list.

Message Presenter
http://Marie%20Dulac,Mapi%20Research%20Trust

Marie Dulac, Author Relations Specialist, Mapi Research Trust

Marie Dulac is an Author Relations Specialist who manages health research questionnaire distribution and licensing for Mapi Research Trust.

Message Presenter

Who Should Attend?

This webinar is intended for senior professionals involved in tobacco research and harm reduction programs from industry, academia and regulatory bodies.

What You Will Learn

Attendees will learn about:

  • The specificities of each measurement instrument and when/how they can be accessed
  • An overview of the ABOUT™–Toolbox instruments which are:
    • Developed and validated with state-of-the-science methods, straightforward to implement, and easy to interpret
    • Relevant to the whole spectrum of tobacco and nicotine-containing products, e.g., cigarettes, e-cigarettes, heated tobacco products, smokeless tobacco
    • Designed to facilitate comparisons of perception and behavior data across academic, industry and public health research communities
  • The rationale and methods used in developing the instruments, as well as insights on their psychometric features, using as examples the ABOUT™ – Perceived Risk and the ABOUT™ – Dependence instruments

 

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Mapi Research Trust

Mapi Research Trust is the official licensor and distributor of over 400 COAs, on behalf of their developers and copyright owners. Please visit our catalog to access the complete list of COAs managed by Mapi Research Trust, or visit our website for additional information on our services to developers and copyright owners.

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