The PhenX (Phenotypes and eXposures) Toolkit provides researchers with recommended standard consensus measures for use in epidemiological, biomedical, clinical and translational studies. To expand the depth and breadth of measures in the PhenX Toolkit, the National Institutes of Health and U.S. Food and Drug Administration have launched a project to identify ‘Core’ and ‘Specialty’ collections of measures recommended for human subjects studies in tobacco regulatory research (TRR). The current paper addresses the PhenX Toolkit TRR Vector specialty area and describes the 6-month process to identify high-priority, low-burden, scientifically supported consensus measures. Self-reported, interviewer-administered and observational measurements were considered, and input from the research community assisted in justifying the inclusion of 13 tobacco industry-relevant measures (mainly interviewer-administered or self-reported measures) in the PhenX Toolkit. Compared with measures of addiction or the use of tobacco products, assessments of many Vector factors are much newer and at an earlier stage of development. More work is needed to refine and validate measures of the spatial distribution of tobacco retailers, retail environment, price promotions and corporate social responsibility.
- advertising and promotion
- tobacco industry
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Collaborators The following are members of the PhenX Tobacco Regulatory Research (TRR) Vector Working Group (WG): Co-Chairs Frank J Chaloupka, University of Illinois at Chicago, and Kurt Ribisl, University of North Carolina at Chapel Hill; Vector WG members Lisa Henriksen, Stanford Prevention Research Center, Tom R Kirchner, New York University, Ruth Malone, University of California, San Francisco, and Rachel Grana Mayne, National Cancer Institute; TRR Panel Liaisons Andrew Hyland, Roswell Park Comprehensive Cancer Center, and Kay L Wanke, NIH Office of Disease Prevention; and the PhenX team from RTI International, including Tabitha Hendershot, RTI TRR Project Lead, Destiney S Nettles, WG Supervisor, and Rebecca Geisler, WG manager.
Contributors GES, TPH and KLW led the conceptualisation of the manuscript and the coordination of the writing team. KMR and GES drafted the scientific content of the manuscript, and DSN and TPH drafted the Methods and Results sections of the manuscript. TRK and KLW reviewed the draft and provided substantive revisions. FJC, LH and RGM reviewed the draft and provided comments. The Co-Chairs and Members of the PhenX TRR Vector WG identified and proposed preliminary measures and voted on final measures included in the PhenX TRR Vector Specialty Collection. TRRP members AH and KLW ensured that the WG process maintained fidelity with overall project goals. Federal Agency Liaison Katherine A Margolis, FDA Center for Tobacco Products, ensured project consistency with agency goals and priorities. NIH Project Coordinator KLW proposed the PhenX TRR initiative and contributed to its execution and completion. The PhenX team coordinated and facilitated the WG process, including project oversight and leadership (TPH), supervisory management (DSN) and project management (RG). PhenX NIH Program Official Erin M Ramos, National Human Genome Research Institute, provided project guidance and funding coordination. Carol M Hamilton, RTI International, is the PhenX Principal Investigator and provided project guidance and supervision.
Funding Research reported in this publication was supported by grant numbers U41HG007050 from the National Human Genome Research Institute (NHGRI) and U41HG007050-01S1 from the NHGRI and FDA Center for Tobacco Products (CTP).
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the FDA.
Competing interests Dr. Ribisl serves as an expert consultant in litigation against tobacco companies. No other interests were declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; internally peer reviewed.
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