Development of recommendations of descriptive consumer-reported outcome measures (descriptive-CROM) and related definitions in tobacco and nicotine research
Background: The Consumer Reported Outcome Measures (CROM) Consortium Task Force (TF), consisting of academic researchers and members from various tobacco companies, was formed within the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) in 2018. The primary objective of the CROM TF is to provide guidance on how to develop, validate, select, access, and use CROM to evaluate tobacco and nicotine-containing products for pre-market and post-market purposes. Working Group 04 (WG04), as one of the CROM TF working groups, was established in 2020 and has the objective of developing recommendations and definitions related to Descriptive-CROM.
Method: Descriptive-CROM are composed of factual items that are direct measures of individual characteristics and behaviors, such as demographics and tobacco product use patterns. Fifteen tobacco surveillance surveys that focus on adult populations were selected for review including two international, eight European, one Japanese, and four US surveys. Question items from the most recent survey questionnaires were discussed and grouped into domains and subdomains.
Results: Recommendations of survey items were made by the core team members and reviewed by advisory board members using a consensus-based approach. Differences between the international and national surveys and gaps in the survey items were identified. Recommendations were also made to align definitions derived from Descriptive-CROM, such as tobacco product dual or poly use, initiation and cessation.
Conclusion: Based on identified domains and recommendations, optimal survey questionnaire items will be summarized to create a publicly available knowledge repository, including conditions and context of use. The repository will facilitate the development and use of Descriptive-CROM to evaluate tobacco and nicotine-containing products for pre-market and post-market purposes.