To inform tobacco harm reduction strategies, a new consumer reported outcome measure (CROM) was developed to assess perceived Health and Functioning (H&F) among users of tobacco and/or nicotine products (TNP). This study assessed the face, content validity, and early measurement properties of the draft H&F CROM.

Cognitive debriefing interviews were conducted in two waves in the UK and US with adult users of: cigarettes (n=20), e-cigarettes (n=20), heated tobacco products (IQOS^TM) (n=20), smokeless tobacco products (n=10), and nicotine replacement therapy products (n=10). Participants completed the draft measure (195 items) electronically through a “think-aloud” process. Different response options were tested. Transcripts were analyzed thematically using Atlas.ti. Exploratory psychometric analysis was conducted by Rasch Measurement Theory (RMT) analysis. Expert panel meetings were held to inform result interpretation and updating the CROM after each wave.

The participants generally endorsed the content of the CROM, while the interim analysis allowed for some early item and scale refinements. The RMT analysis largely supported the scales’ reliability, sample-to-scale targeting, and discrimination potential across the TNP user groups. Conceptual overlap between some items was identified through both qualitative and quantitative evidence. Mixed-methods evidence was used to guide the selection of response scale, e.g., severity difficulty or frequency that could better match the underlying concept of each scale, while the 7-day recall period was found to have less of a ceiling effect.

This study provides early supporting evidence of the new H&F CROM’s content relevance, clarity, and ease of completion. It comprises ten scales (146 items) covering different health concepts (including oral, lung, and general health and breathing difficulty), appearance, bother with TNP smell, as well as different functioning concepts (including work, social, and well-being). A psychometric validation study is being conducted to inform the item content, scoring structure, and measurement properties of the CROM.