CORESTA Guidelines for Descriptive Consumer-Reported Outcome Measures in Tobacco and Nicotine Research

Summary Introduction Descriptive Consumer-Reported Outcome Measures (CROM) are self-reported survey outcome measures intended to measure observable characteristics and behaviors in research on tobacco- and nicotine-containing products (TNPs). The wide variety of available TNPs and the continued development of new TNPs require a constant evolution of measures to assess TNP use and related constructs adequately. The guidelines aim to provide recommendations on the selection, development, implementation, and analysis of Descriptive CROM in research on TNPs. Methods The best practices and guidelines on Descriptive CROM were developed via an iterative and consensus-driven approach by the Descriptive CROM working group within the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) CROM Task Force. This involved reviewing relevant national and international surveys, peer-reviewed publications, publicly available guidelines, and best practices published by professional institutes in related fields. The Descriptive CROM working group also collaborated with other CORESTA subgroups and relevant subject matter experts representing public health, academia, and the tobacco industry to continuously update the guidelines. Results The resulting guidelines contain four main sections. First, we introduce the Descriptive CROM domain framework and provide definitions and descriptions of TNP categories and use patterns. Second, based on review of existing Descriptive CROM from national and international surveys, recommendations on Descriptive CROM for TNP research are provided. Third, the guidelines provide recommendations related to the development, modification, and adaptation of Descriptive CROM. This section includes a multi-stage process for CROM development, including item generation and qualitative and quantitative assessments of the CROM. The final section on Descriptive CROM implementation includes recommendations for best practices from the CORESTA organization for study design and development, data analysis, and reporting of Descriptive CROM data. Conclusions The recommendations on the development, modification, and application of Descriptive CROM are grounded in scientific rationale and developed with consensus from the CORESTA TNP research community. The consensus Descriptive CROM measures, along with consistent definitions, could facilitate comparisons across studies, aggregation of data sets, and improve harmonization in research findings. As best practices and guidelines may evolve over time, the CORESTA CROM Task Force will continue to update the guidelines based on the dynamic TNP landscape and regulatory requirements to advance TNP research.