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PhenX: Vector measures for tobacco regulatory research.

ABSTRACT: 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.

SUBMITTER: Ribisl KM

PROVIDER: S-EPMC7842080 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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PhenX: Vector measures for tobacco regulatory research.

Ribisl Kurt M KM Chaloupka Frank J FJ Kirchner Thomas R TR Henriksen Lisa L Nettles Destiney S DS Geisler Rebecca C RC Hendershot Tabitha P TP Swan Gary E GE

Tobacco control 20200101 Suppl 1

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 pap ...[more]

PMID: 31992661

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Project description:BACKGROUND:The purpose of this paper is to describe the data collection efforts and validation of PhenX measures in the Personalized Medicine Research Project (PMRP) cohort. METHODS:Thirty-six measures were chosen from the PhenX Toolkit within the following domains: demographics; anthropometrics; alcohol, tobacco and other substances; cardiovascular; environmental exposures; cancer; psychiatric; neurology; and physical activity and physical fitness. Eligibility criteria for the current study included: living PMRP subjects with known addresses who consented to future contact and were not currently living in a nursing home, available GWAS data from eMERGE I for subjects where age-related cataract, HDL, dementia and resistant hypertension were the primary phenotypes, thus biasing the sample to the older PMRP participants. The questionnaires were mailed twice. Data from the PhenX measures were compared with information from PMRP questionnaires and data from Marshfield Clinic electronic medical records. RESULTS:Completed PhenX questionnaires were returned by 2271 subjects for a final response rate of 70%. The mean age reported on the PhenX questionnaire (73.1 years) was greater than the PMRP questionnaire (64.8 years) because the data were collected at different time points. The mean self-reported weight, and subsequently calculated BMI, were less on the PhenX survey than the measured values at the time of enrollment into PMRP (PhenX means 173.5 pounds and BMI 28.2 kg/m2 versus PMRP 182.9 pounds and BMI 29.6 kg/m2). There was 95.3% agreement between the two questionnaires about having ever smoked at least 100 cigarettes. 139 (6.2%) of subjects indicated on the PhenX questionnaire that they had been told they had a stroke. Of them, only 15 (10.8%) had no electronic indication of a prior stroke or TIA. All of the age-and gender-specific 95% confidence limits around point estimates for major depressive episodes overlap and show that 31% of women aged 50-64 reported symptoms associated with a major depressive episode. CONCLUSIONS:The approach employed resulted in a high response rate and valuable data for future gene/environment analyses. These results and high response rate highlight the utility of the PhenX Toolkit to collect valid phenotypic data that can be shared across groups to facilitate gene/environment studies.

Project description:IntroductionFlavored electronic nicotine delivery systems (ENDS) and tobacco products are associated with the initiation and progression of tobacco use. With recent restrictions around flavored products, it is critical to measure both the product and the flavor being used. The Tobacco Centers of Regulatory Science (TCORS) Flavored Tobacco Products Measurement Subcommittee (FTPMS) was established to develop core measures to assess flavored tobacco and ENDS product usage, facilitate data harmonization, replicability, and comparisons across studies.Aims and methodsThe FTPMS used a mixed-method approach to inform the development of recommended measures (first use, current use, reasons for use) to assess tobacco and ENDS product flavors. This included reviewing existing surveys, identifying priority areas, developing new measures, cognitive testing, and finalization of recommended measures.ResultsRecommended measures were selected from national surveys (e.g. PATH study) and survey items used in TCORS studies to evaluate first use, current use, and reasons for use of tobacco and ENDS products. Response options were expanded for questions about specific flavors and adapted to allow for assessments relevant to recent federal policies. Supplemental measures were developed for researchers conducting more in-depth research around flavored products.ConclusionsUsing an expert consensus process supplemented with cognitive testing, the FTPMS developed recommendations for core and supplemental measures for flavored tobacco and ENDS products. Harmonizing data on these factors for flavored tobacco and ENDS products are critical for researchers and may provide actionable evidence to federal, state, and local regulators and policymakers, as well as support evaluations of policies restricting flavors in these products.ImplicationsThe development of core measures to assess first use, current use, and reasons for use of flavored tobacco and ENDS products will facilitate data harmonization, replicability, and comparisons across studies conducted in different samples or across communities with varying levels of regulation for these products. Use of these standardized measures will allow for a greater understanding of the role of flavors and helps to build a more robust evidence base to inform regulatory decisions to reduce tobacco and ENDS use at the population level.

Project description:The popularity of electronic cigarettes in the United States and around the world has led to a startling rise in youth nicotine use. The Juul® e-cigarette was introduced in the U.S. market in 2015 and had captured approximately 13% of the U.S. market by 2017. Unlike many other contemporary electronic cigarette companies, the founders behind the Juul® e-cigarette approached their product launch like a traditional high-tech start-up company, not like a tobacco company. This article presents a case study of Juul's corporate and product development history in the context of US regulatory actions. The objective of this article is to demonstrate the value of government-curated archives as leading indicators which can (a) provide insight into emergent technologies and (b) inform emergent regulatory science research questions. A variety of sources were used to gather data about the Juul® e-cigarette and the corporations that surround it. Sources included government agencies, published academic literature, non-profit organizations, corporate and retail websites, and the popular press. Data were disambiguated, authenticated, and categorized prior to being placed on a timeline of events. A timeline of four significant milestones, nineteen corporate filings and events, twelve US regulatory actions, sixty-four patent applications, eighty-seven trademark applications, twenty-three design patents and thirty-two utility patents related to Juul Labs and its associates is presented, spanning the years 2004 through 2020. This work demonstrates the probative value of findings from patent, trademark, and SEC filing literature in establishing a premise for emergent regulatory science research questions which may not yet be supported by traditional archival research literature. The methods presented here can be used to identify key aspects of emerging technologies before products actually enter the market; this shifting policy formulation and problem identification from a paradigm of being reactive in favor of becoming proactive. Such a proactive approach may permit anticipatory regulatory science research and ultimately shorten the elapsed time between market technology innovation and regulatory response.

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PhenX: Vector measures for tobacco regulatory research.

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PhenX: Vector measures for tobacco regulatory research.

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