A consortium approach for consumer-reported outcome measures to assess tobacco- and nicotine-containing products
In the tobacco space, consumer-reported outcome measures (CROM) are essential for understanding motivations, subjective effects, and behavior. Such measures have become particularly important with the advent of candidate modified risk tobacco products (cMRTP). Here we present the preparatory steps for a consortium approach initiated by the tobacco industry to develop, validate, use, and access CROM to assess tobacco- and nicotine-containing products (TNP), including cMRTPs. A CROM Task Force was formed within the CORESTA Product Use Behaviour Sub-Group. To refine goals, research questions, and scope of work, we reviewed 12 documents, including U.S. Food and Drug Administration (FDA) MRTP briefing package submissions (in the context of applications submitted by Altria Client Services, Philip Morris Products, Swedish Match, Reynolds), regulatory documents (FDA Premarket Tobacco Product and MRTP Applications, FDA Over-the-Counter label comprehension, EU Directive), review papers, and public health reports (U.S. Institute of Medicine, FDA Center for Tobacco Products activities). Data relating to self-report measures were extracted (i.e. concepts to be measured and methods recommended and/or used). The review revealed the need to propose a consensual definition of consumer-reported outcomes (CRO), categorize the concepts of interest measured to assess TNPs (including cMRTPs), and develop a common taxonomy and definition to qualify them. The review also highlighted unclear recommendations or best practices from guidance documents issued by different regulatory agencies on how each concept should be assessed. The Task Force will present a proposal for a definition of CROs, a draft concept taxonomy, and a summary of the information extracted relevant to each concept. The key outcomes presented here form the foundations of the CROM consortium. This work should facilitate a dialogue on requirements to develop common terminology, standards, and best practices for CROM in the tobacco space and emphasizes the need for more discussion between industry, academia, and regulatory body stakeholders.