PhenX Measures for Tobacco Regulatory Research (TRR)
The Food and Drug Administration's Center for Tobacco Products (CTP) and the National Institutes of Health Tobacco Regulatory Science Program (TRSP) are seeking to expand the depth and breadth of tobacco-related measures that can enhance cross-study analysis in large-scale research. TRSP and CTP recognized that the science base for tobacco regulation would be growing. As a result, they set a goal to establish consensus measures in tobacco regulatory research for investigators that would enable collaboration, allow for future data comparison, validation, replication, and harmonization.
Evolving Tobacco Regulatory Research Environment
Working group (WG) members identified and selected protocols which are currently in use (as described in the criteria for selection below). Tobacco Regulatory Research (TRR) is a growing and developing field. As such, the WGs acknowledge that while this TRR collections are comprised of well established, validated measurement protocols, measures continue to be developed and adapted to reflect the evolving field. These measures are expected to become important tools for the TRR community in the future. The evolving variety of tobacco products alone warrants continued modification of measures, from survey items to biomarkers to laboratory assessments, in order to effectively assess tobacco use and dependence. Specific instructions included with several of the measures in the TRR collections note the WG's expert opinions as to the appropriateness of modifying cigarette smoking measures for the purpose of assessing other tobacco products. The WGs expect many more measures for e-cigarettes and other emerging tobacco products to become available for use in TRR.
Tobacco Regulatory Research Panel (TRRP)
A nine-member Tobacco Regulatory Research Panel (TRRP), chaired by Drs. Gary Swan and Jodi Prochaska, was convened to facilitate the inclusion of a
core collection and five "Specialty" collections of TRR measures in the Toolkit. Based on the HAVE
(Host, Agent, Vector, and Environment) framework, the TRRP scoped the following five Working Groups (WGs):
| WG Name | Description |
|---|---|
| Social/Cognitive | Assess the intrapersonal factors that influence product use, including cognitive, affective, motivational, and perceptive factors, such as risk perceptions, perceived norms, stress, and motivation to quit. |
| Biobehavioral | Assess the descriptive, behavioral, or biological measures that characterize product use, exposure, and potential or actual adverse health outcomes, such as patterns of use, cue reactivity, biomarkers, and genetics. |
| Agent | Assess the tobacco product, such as variety, brand, toxicology, and warning labels. |
| Vector | Assess the industry and retailer activities, such as packaging, advertising, price, and purchase location. |
| Environment | Assess other environmental factors influencing tobacco use, such as Clean Air policies, exposure to anti-tobacco campaigns, and cultural and community factors. |
Tobacco Regulatory Research Working Groups
Each WG was composed of five to eight scientists with relevant expertise. Each WG had a chair or co-chairs, including two non-voting liaisons from the TRRP,
and was supported by an RTI WG supervisor and manager. The five WGs were convened between 2014 and 2015. Each WG identified up to 12 measures per specialty area,
using a consensus process to deliver a set of high-priority measures for inclusion in the PhenX Toolkit.
The WGs selected measures for the PhenX TRR Toolkit using criteria suggested by the PhenX Steering Committee. The criteria for selecting PhenX measures
stipulate that they are:
- Clearly defined
- Well established and have demonstrated utility
- Broadly applicable and generally accepted
- Low burden to participants and investigators
- Reproducible
- Specific
- Reliable
- Available and have existing standard measurement protocols
- Crosscutting relevance across population groups as well as diseases and conditions
- Use in major reference study (e.g., the National Health and Nutrition Examination Survey)
- Open-source software and nonproprietary instruments preferred
- Brevity
- Expectation of acceptance by the research community
Tobacco Regulatory Research Panel
| Jodi Prochaska, PhD, MPH (Co-Chair) Stanford University |
Robin Mermelstein, PhD University of Illinois at Chicago |
| Gary Swan, PhD (Co-Chair) Stanford University |
Dana van Bemmel, PhD, MPH Food and Drug Administration |
| Neal Benowitz, MD University of California ? San Francisco |
Kay L. Wanke, PhD, MPH National Institutes of Health |
| Kevin Conway, PhD National Institute on Drug Abuse |
Gordon Willis, PhD National Cancer Institute |
| Andrew Hyland, PhD Roswell Park Cancer Institute |
PhenX TRR Senior Management Team
RTI International
| Carol M. Hamilton, PhD Principal Investigator |
Deborah R. Maiese, MPA Consensus Coordinator |
| Tabitha P. Hendershot Co-Investigator |
Amanda Riley, PMP Project Manager |
| Darigg C. Brown, PhD, MPH TRRP Coordinator |
National Human Genome Research Institute
| Erin M. Ramos, PhD, MPH Project Scientist |
Brenda Iglesias, BA PhenX Scientific Program Analyst |
National Institutes of Health, Office of Disease Prevention
| Kay L. Wanke, PhD, MPH Deputy Director, Tobacco Regulatory Science Program |