THE DEVELOPMENT OF A NEW MEASUREMENT INSTRUMENT TO ASSESS HEALTH AND FUNCTIONING AMONG TOBACCO AND NICOTINE PRODUCT USERS- THE PREPARATORY PHASE
Author(s)
Spies E1, Bacso A2, Afolalu EF1, Abetz-Webb L3, Gallot S1, Law V4, Floyd D4, Weitkunat R1, Chrea C1
1PMI R&D, Philip Morris Products S.A., Neuchâtel, Switzerland, 2PMI R&D, Philip Morris Products S.A., Neuchâtel, NE, Switzerland, 3Patient-Centred Outcomes Assessments, Bollington, UK, 4Zebra26 Ltd, Cheshire, UK
OBJECTIVES: Switching cigarette smokers to reduced-risk products (RRPs1) 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. 1 Reduced-Risk Products (“RRPs”) is the term PMP SA 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 these products versus continued smoking. PMP SA has a range of RRPs in various stages of development, scientific assessment and commercialization. Because RRPs do not burn tobacco, they produce far lower quantities of harmful and potentially harmful compounds than found in cigarette smoke.
Conference/Value in Health Info
2019-05, ISPOR 2019, New Orleans, LA, USA
Value in Health, Volume 22, Issue S1 (2019 May)
Code
PNS242
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation
Disease
No Specific Disease