OBJECTIVES: US Food & Drug Administration Center for Tobacco Products’ Premarket Tobacco Product Applications (FDA CTP PMTA) require assessment of the public health impact of New Tobacco Products (NTP) to gain approval via Marketing Granted Orders. PMTA assessment must inform on individuals’ product experience of NTP, and Consumer Reported Outcome Measures (CROMs) are central in generating this evidence-base. Originally referred to as the Smoking Effects Inventory (SEI), the modified Cigarette Evaluation Questionnaire (mCEQ) assesses reinforcing effects of smoking cigarettes and was adapted to evaluate subjective effects of NTP use. The study objective was to evaluate product experience CROMs adapted from the mCEQ for use in real-world evidence (RWE) generation for regulatory engagement.

METHODS: We reviewed the literature on the development and validation of the mCEQ along with the measurement properties of CROM adaptations: (1) the Product Evaluation Scale (PES), (2) the Tobacco and Nicotine Product Experience Questionnaire (ToNiPEQ; aka the ABOUT-Product Experience), (3) the mCEQ-C, mCEQ-E, and mCEQ-N, and (4) the Modified E-Cigarette Evaluation Questionnaire (MECEQ).

RESULTS: CROMs adapted from the mCEQ assess the reinforcing effects of product use in adult population of tobacco and nicotine product users. These CROMs inherited strengths and limitations from the original instrument, also considering the SEI/mCEQ was validated to evaluate clinical interventions towards smoking cessation. While the original structure of the three multi-item domains was confirmed using the Rasch model, studies using factor analysis suggested alternative structures. Empirical confirmation of the multidimensional conceptual model is complicated by two single-item domains.

CONCLUSIONS: Selecting optimal product experience CROMs for use in assessment studies requires considerations of instruments characteristics. Together with novel study design elements, appropriate psychometric CROMs have the potential to capture RWE insights concerning one individual’s journey (stages, moments). Characterizing product experience elements contributing to a desired behavioral change could further support tobacco harm reduction.