Common Measures to Evaluate Flavored Tobacco Products: Recommendations From the Tobacco Centers for Regulatory Science (TCORS) Flavored Tobacco Products Measurement Subcommittee.

INTRODUCTION: Flavored 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 METHODS: The 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. RESULTS: Recommended 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. CONCLUSIONS: Using 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. IMPLICATIONS: The 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.

Influence of data disclosures on physician decisions about off-label uses: findings from a qualitative study.

BACKGROUND: Prescribing approved products for unapproved uses (off-label use) is not uncommon among physicians in certain medical specialties. Available evidence about an off-label use - both supportive and unsupportive - can influence prescribers' decisions about a drug's appropriateness for a particular case. The objectives of this study were: (1) to examine physician perceptions about off-label uses generally, including their awareness of unsupportive data; and (2) to explore the influence of disclosure information about unsupportive data on off-label prescribing decisions. METHODS: Semi-structured interviews were conducted between December 2019 and January 2020 with oncologists (n = 35) and primary care physicians (n = 35). Interviews explored general prescribing practices, understanding of and information sources for learning about off-label use of prescription drugs, awareness of unsupportive data related to off-label uses, and preferences and reactions to disclosure statements about the existence of unsupportive data related to an off-label use. RESULTS: Most participants reported prescribing drugs for off-label uses (with half reporting regular off-label prescribing). However, among those who prescribe off-label, approximately two-thirds had never seen unsupportive data about off-label uses. Physicians preferred a disclosure statement that provided a summary of the unsupportive data about the off-label use; this statement also led most physicians to say they were unlikely or less likely to prescribe the drug for that use. CONCLUSIONS: This study suggests that physicians' decision-making about prescribing for off-label uses of approved drugs may be influenced by awareness of unsupportive data. Our interviews also suggest that providing more information about unsupportive study findings may result in a reduction in reported prescribing likelihood.

Mentoring for Success in Tobacco Regulatory Science: A Qualitative Study.

OBJECTIVES: Our study explores the experiences of early career and senior scientists regarding mentorship and career trajectories in tobacco regulatory science (TRS). METHODS: We conducted 22 phone interviews with early career and senior tobacco regulatory scientists from July 2015 to January 2016. All interviews were conducted using a structured interview guide and analyzed using a thematic approach by 2 independent coders. RESULTS: TRS presents specific opportunities and challenges to scientists due to its focused goal of informing tobacco regulation. An understanding of US Food and Drug Administration (FDA) research priorities and how science can inform tobacco regulation are essential for effective mentorship in TRS. Careers in TRS can be pursued in various academic and non-academic professional roles; both offer the distinct ability to conduct science that impacts public policy. Early career and senior scientists identified the importance and challenge of providing broad training across the diverse disciplines of TRS. CONCLUSIONS: Effective mentorship in TRS requires that mentors possess an in-depth understanding of the scientific, regulatory, and legislative processes inherent to tobacco regulatory policy-making. A training program for mentors specific to TRS has the potential to meet diverse professional needs of mentors and mentees aiming to impact tobacco policy.