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.
For each of these research areas, the WGs selected consensus measures to include in the five corresponding "Specialty" Collections. TRRP members served as liaisons to the WGs, providing on-going guidance through the process to identify well-established TRR measurement protocols. The TRRP was also charged with constructing a "Core" Collection for TRR from measures in the research domains as well as new measures released by the TRR project.

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
Additional criteria for selecting PhenX measures include:
  • 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
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