Posters

      The development of a new measurement instrument to assess health and functioning among tobacco and nicotine product users: the preparatory phase

      Spies, E.; Bacso, A.; Afolalu, E.; Abetz-Webb, L.; Gallot, S.; Law, V.; Floyd, D.; Weitkunat, R.; Chrea, C.
      Conference date
      May 22, 2019
      Conference name

      ISPOR 2019
      Link to more information
      Topic
      Summary

      Objectives: Switching cigarette smokers to reduced-risk products (RRPs) has been recognized as a valuable and promising approach to reduce smoking-related population harm. The present project aims to develop a new self-report measurement instrument to assess the impact of RRPs on health and functioning, and ultimately evaluate the population-level health impact of switching to RRPs. Methods: Using a stepwise approach based on the FDA's Guidance on Patient-Reported Outcome Measures, to date a scoping literature review, secondary analyses of in-house qualitative focus group (N = 229) and interview (N = 40) studies, and the convening of an expert panel have been completed. Results: Ninety publications were included in the literature review. Publications overwhelmingly focused on cigarette use and associated health effects (e.g., mental and oral health), with less than 10% focusing on e-cigarettes and alternative nicotine delivery products. Results from existing qualitative research identified key drivers for continuing smoking: perceived benefits of smoking, addiction, lack of control, and withdrawal symptoms or fear of withdrawal symptoms. Lastly, the expert panel supported the preliminary conceptual model incorporating the concepts of utility of use, biomarkers, signs and symptoms, functioning, general health perceptions and quality of life. Conclusions: Derived from the triangulation of published literature, qualitative data, and expert opinion, the preliminary conceptual model will be refined through the completion of additional qualitative studies of RRP users.

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      Reduced Risk Products ("RRPs”) is the term we use 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 these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.