Recently, novel tobacco and nicotine-containing products have been developed to reduce consumer exposure to harmful substances from smoking combustible tobacco products. Consumer-reported outcome measures (CROM) might help inform on the public health impact of these novel products. For historical reasons, the CROM that have been developed in tobacco and nicotine research to better understand users and non-users’ motivations, perceptions and behaviors have focused on cigarettes. This raises the question whether these measures are fit for purpose for novel tobacco and nicotine-containing products. Only very recently have these measures been developed in response to changed tobacco and nicotine delivery device use. However, there is currently no consensus assessment of the scientific merits of different instruments to further the development of international standards for the development, validation, identification, access and use of CROM for assessing tobacco and nicotine-containing products. To support regulatory decision-making on such products, there is a need for developing scientifically credible standards to ensure that CROM are valid and reliable, and used as per the intended context of use.

This virtual symposium provided a forum to engage various stakeholders and including tobacco industry, academic researchers, and public health community to discuss the use of CROM in regulatory decision-making processes and explore how the CROM Consortium within the CORESTA framework could serve as a multi-stakeholder collaborative platform to enhance the harmonization of CROM in tobacco regulatory science.

Programme and Presenters

Part I:  Setting the Scene for CROM

• A consortium approach for consumer-reported outcome measures for assessing tobacco and nicotine-containing products
  Christelle CHREA, PhD
• The FDA Guidance on PROs and the Regulation of Modified Risk Tobacco Products
  Donald PATRICK, PhD

Part II:  Case Studies on CROM

• Use of qualitative research to ensure we measure what matters to users of tobacco and/or nicotine products
  Esther AFOLALU, PhD
• Measurement Matters: Psychometric Analysis of the PATH Youth Dependence Scale
  Ryan BLACK, PhD and Saul SHIFFMAN, PhD
• Establishing traceability of self-reported dependence measurement through the use of crosswalks
  Thomas SALZBERGER, PhD