Development of the ABOUT™–Health & Functioning: results from the preparatory phase
Switching cigarette smokers to significantly less harmful tobacco or nicotine products, or reduced-risk products (RRPs), has been recognized as a valuable and promising approach to reduce smoking-related population harm. Measuring self-reported experience of the change in health and functioning is crucial to evaluating RRPs’ impact on public health. 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. The goal of the ABOUT™–Health & Functioning, part of the Philip Morris Products ABOUT™ Toolbox initiative, is to develop a sensitive self-report measure that will assess changes in health and functioning among healthy smokers who switch to RRPs. The project is designed to be carried out over three years and will follow the U.S. Food and Drug Administration’s Guidance on Patient-Reported Outcome Measures. The preparatory phase of the measurement instrument development included a scoping literature review, secondary analyses of existing qualitative studies, and convening of an expert panel. The literature review indicated that publications overwhelmingly focused on cigarette use and associated health effects (e.g. respiratory or oral health), with less than 10 % focusing on e-cigarettes and alternative nicotine delivery products. Results from analysis of existing qualitative research identified key drivers for continuing smoking: perceived benefit of tobacco or nicotine product use, dependence, 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 health-related quality of life. These activities led to the development of a draft conceptual model for the measurement instrument. In the next phase, the conceptual model will be refined through concept elicitation studies, a global Delphi panel, and the reconvening of the project`s expert panel.