PNS46 Development of Consumer-Reported Outcome Measure (CROM) Standards for the Tobacco Industry with Respect to Psychometric CROM Using a Consortium-Based Approach: Methodology and Scope

Abstract

In November 2018, CORESTA approved the formation of a new Task Force (TF) to establish best practices and guidelines for the integration of consumer-reported outcome measures (CROM) in tobacco regulatory research. The primary objective of the CROM TF is to provide guidance on how to identify, develop, and validate CROM, and to provide access to CROM for evaluating tobacco and nicotine-containing products for pre-market and post-market purposes. Here, we describe the research completed by one of the TF working groups, WG02, with the purpose of developing CROM standards for tobacco regulatory research with respect to psychometric CROM (i.e., CROM intended to measure underlying psychological attributes – e.g., reinforcing effects). WG02 comprises 11 researchers from the CROM TF, representing 7 different tobacco companies and with experience in psychometrics, patient-reported outcomes (PRO), survey methodology, and product use behavior. WG02 members collaboratively drafted an operational definition of psychometric CROM and devised an approach for developing the standards. Consistent with approaches taken by other outcomes research organizations WG02 adopted a consensus-based approach for drafting the standards, which includes (1) review of literature and (2) an iterative peer-review process leveraging various sources, such as conference presentation and review by subject matter experts from tobacco, PRO, and related fields. Through literature review and WG02 member input, the scope was defined and initial content for the 5 components of the standards was drafted. These components include: (1) appropriate content, (2) development process and validation, (3) adaptation/modification of existing CROM, (4) application/implementation and interpretation of CROM, and (5) linguistic/cultural translation. This research represents the development of draft standards for Psychometric CROM for tobacco regulatory research, with the intention to complement 2020 draft guidance issued by the Food and Drug Administration Center for Tobacco Products. The initial draft content is being disseminated for peer-review.