Improving E-Cigarette Research through Measurement and Design ANDREA VILLANTI, PHD MPH E-CIGARETTE SUMMIT MAY 8, 2017

Transcription

1 Improving E-Cigarette Research through Measurement and Design ANDREA VILLANTI, PHD MPH E-CIGARETTE SUMMIT MAY 8, 2017

2 Disclosures Andrea Villanti, PhD, MPH Director for Regulatory Science and Policy The Schroeder Institute for Tobacco Research and Policy Studies at Truth Initiative Associate Professor Department of Psychiatry Vermont Center on Behavior and Health University of Vermont This work was supported by Truth Initiative and RWJF Other funding from FDA (HHSN: C) and NIH (U54CA189222; R03CA187756; R21DA041548; R03DA042010; P50DA036114; P20GM103644) No support from any industry sources Opinions expressed are solely our own and do not necessarily reflect those of Truth Initiative, University of Vermont, or any funding agencies.

3 Research is focused on the public health impact of e-cigarettes

4 How to assess impact on public health? FDA s public health standard calls for the review of the scientific evidence regarding 1. Risks and benefits of the proposed rule to the population as a whole, including both users and non-users of tobacco products; 2. Whether there is an increased or decreased likelihood that existing users of tobacco products will stop using such products; and 3. Whether there is an increased or decreased likelihood that those who do not currently use tobacco products, most notably youth, will start to use tobacco products 4

5 Trajectories of e-cigarette use? Cobb CO, et al. Markov modeling to estimate the population health impact of emerging tobacco products: A proof-of-concept study. Tob Reg Sci. 2015;1(2):

6 E-cigarette Policy Research Framework Psychosocial Mediators Tobacco Control Policies Exposure to Policy Tobacco Use Behavior Outcomes Moderators

7 Am J Prev Med 2017;52:e33-e66.

8 Lesson 1: Products matter.

9 E-cigarettes are not a single product class First generation Cigalikes Second generation Mid-size electronic cigarettes Third generation Advanced personal vaporizers

10 E-cigarette nicotine delivery Farsalinos KE, Spyrou A, Tsimopoulou K, Stefopoulos C, Romagna G, Voudris V. Nicotine absorption from electronic cigarette use: comparison between first and new-generation devices. Scientific Reports. 2014;4:4133.

11 E-cigarette nicotine delivery Wagener TL, Floyd EL, Stepanov I, et al. Tob Control 2017;26:e23-e8.

12 E-cigarette manufacturers vary

13 U.S. Dollars (Millions) Advertising is impacted by manufacturer $140 $120 E-cigarette Advertising Expenditures, U.S. Reynolds launches Vuse Altria launches MarkTen $115 $100 $80 $60 Lorillard acquires blu ecigs $76 $40 $20 $- $22 $12 $ Year

14 Products matter 1. E-cigarettes are a heterogeneous group of products, typically not differentiated in surveys 2. These products vary in nicotine delivery and consumer satisfaction both of which are likely to impact their uptake 3. There are no established quality or safety standards for these products 4. Variety of e-cigarette manufacturers; not just cigarette companies 5. Product advertising largely driven by cigarette company products Source:

15 Lesson 2: Context matters.

16 Prevalence of past 30-day cigarette use Prevalence of past 30-day smoking among 12 th graders in the US, Year Monitoring the Future. Table

17 Prevalence Past 30-day tobacco and e-cigarette use among high school students, NYTS % Cigarettes Electronic Cigarettes Any Tobacco Product 25% 24.1% 24.1% 25.3% 21.7% 21.6% 20% 16.0% 15% 15.8% 13.4% 14.0% 12.7% 10% 9.2% 9.3% 5% 4.5% 2.8% 1.5% 0% Year 17 Source: National Youth Tobacco Survey,

18 Prevalence Past 30-Day E-Cigarette Use by Grade and Year 18% 16% 16.2% 17.1% 16.2% 14% 14.0% 12% 12.5% 10% 8% 8.7% 9.5% 11.0% % 4% 6.2% 2016* 2% 0% 8th Grade 10th Grade 12th Grade *Question broadened to ask about use of electronic vaporizers 18 Source: Monitoring the Future, 2014, 2015, and 2016

19 Percentage (%) Distribution of tobacco and e-cigarette co-use among U.S. middle and high school students (weighted); NYTS, % 90.7% E-cigarette use frequency 80% 60% Any combustible use Non-combustible use Exclusive e-cigarette use No past 30-day use 83.0% 40% 20% 0% 1.1% 6.6% 4.4% 1.5% 1.1% 1.0% 0.5% 0.9% 0 Days 1-2 Days 3-5 Days 6-9 Days Days Days All 30 Days Villanti et al. Nicotine Tob Res Epub ahead of print, Dec 24.

20 Percentage (%) Distribution of tobacco and e-cigarette co-use among past 30- day e-cigarette users (weighted); NYTS, % 4.4% E-cigarette use frequency 4.0% Any past 30-day combustible use 3.0% 2.0% 2.2% 0.2% Past 30-day Non-combustible use Exclusive past 30-day e-cigarette use 1.5% 1.0% 0.0% 2.0% 1-2 Days 0.5% 1.0% 3-5 Days 0.0% 1.1% 1.0% 0.3% 0.2% 0.1% 0.1% 0.7% 0.7% 6-9 Days Days 0.5% 0.4% Days 0.1% 0.0% 0.9% 0.1% 0.7% All 30 Days 0.0% Villanti et al. Nicotine Tob Res Epub ahead of print, Dec 24.

21 Youth frequency of product use, 2014 NYTS 5.0% Cigarette use 5.0% Smokeless tobacco use 4.0% 4.0% 3.0% 2.4% 3.0% 2.0% 1.0% 0.0% 0.6% 1.8% 0.8% 0.6% 0.6% 0.5% 0.2% 0.1% 0.1% 0.1% 0.7% 0.5% 0.5% 0.4% 1.4% 1.2% 1-2 days 3-5 days 6-9 days days days All 30 days Poly-use in past 30 days Exclusive use in past 30 days 0.1% 2.0% 1.0% 0.0% 1.1% 1.1% 0.4% 0.7% 0.4% 0.4% 0.4% 0.4% 0.1% 0.1% 0.1% 0.1% 0.3% 0.3% 0.3% 0.3% 0.2% 0.9% 1-2 days 3-5 days 6-9 days days days All 30 days Poly-use in past 30 days Exclusive use in past 30 days 5.0% Cigar use 5.0% 4.4% E-cigarette use 4.0% 4.0% 3.0% 2.8% 3.0% 2.2% 2.0% 1.0% 0.0% 0.6% 2.1% 1.0% 0.2% 0.8% 0.5% 0.5% 0.1% 0.1% 0.4% 0.4% 0.3% 0.5% 0.0% 0.1% 0.2% 0.4% 1-2 days 3-5 days 6-9 days days days All 30 days Poly-use in past 30 days Exclusive use in past 30 days Villanti et al. Nicotine Tob Res Epub ahead of print, Dec % 1.0% 2.2% 0.5% 1.0% 0.0% 1.5% 1.1% 1.0% 0.3% 0.2% 0.8% 0.8% 0.5% 0.9% 0.1% 0.1% 0.8% 0.4% 1-2 days 3-5 days 6-9 days days days All 30 days Poly-use in past 30 days Exclusive use in past 30 days

22 Prevalence Substance Use in Past 30-Days among 12 th Graders 40% 37.4% 35% 30% 25% 20% 17.1% 21.2% 15% 11.9% 13.6% 10% 5% 6.4% 7.0% 0% Large Cigars Little Cigars Flavored Little Cigars Source: Monitoring the Future 2015 (Table 3) Cigarettes E-Cigarettes Marijuana Alcohol Any Combustible Use 22

23 Context matters Youth cigarette use continues to decline. Youth e-cigarette use increased from 2011, but seems to have leveled off or decreased in the past 2 years. Total tobacco product and e-cigarette use in youth has not declined since Polytobacco use is the dominant pattern in youth. E-cigarette and tobacco product use occurs in the context of: Other substance use Marketing

24 Lesson 3: Measurement matters.

25 Prevalence (%) Ever E-cigarette Use in Youth and Adults, Middle & HS students >65 Age 25 Source: 2014 NYTS; Delnevo (2015) Patterns of Electronic Cigarette Use Among Adults in the United States; Data NHIS, 2014

26 Prevalence (%) E-cigarette Use in Youth and Adults, Ever e-cigarette use Daily e-cigarette use Middle & HS students >65 Age 26 Source: 2014 NYTS; Delnevo (2015) Patterns of Electronic Cigarette Use Among Adults in the United States; Data NHIS, 2014

27 What measures are relevant to assessing public health impact? Frequency Number of days used in the past 30 Never use Ever use Current/ regular use Intensity Number of times products used on days used in the past 30

28 Measurement methods impact estimates E-cigarette (overall) Forced choice Ever use Past 30-day use Forced choice Check-all-thatapply Check-all-thatapply 24.1% 14.9% 12.2% 6.1% Delnevo et al. Am J Epidemiol 2017:1-6.

29 Measurement matters 1. Terminology is important What is use? Ever vs. past 30-day vs. more detailed measures? 2. Need more meaningful measures of exposure High rates of experimentation 3. Measurement methods affect prevalence estimates 4. Few national surveys ask more detailed e-cigarette items Device type Nicotine vs. non-nicotine Reasons for use

30 Recommended minimum core items to assess e-cigarette use in national surveys KEY CONSTRUCTS Ever use Frequency of use Relative harm Former daily use Device type Presence of nicotine Flavor preference Primary reason for use (Pearson et al. Manuscript under review.) Table 1. Recommended minimum core items to assess e-cigarette use in national surveys. Construct Item Response options Population/Respondents CORE ITEM Ever use CORE ITEM Frequency of Use Relative harm Former daily use Device type Have you ever tried an e- cigarette or vaping device? How often do you currently use an e-cigarette or vaping device? Compared to cigarettes, how harmful are e-cigarettes to a person health? Have you ever used an e- cigarette or vaping device daily for a month or more? What e-cigarette or vaping device [do/did] you use (the most)? a) Yes b) No c) Don t know a) Daily or almost daily b) Less than daily, but at least once a week c) Less than weekly, but at least once a month d) Less than monthly e) Not at all f) Don t know a) Much less harmful than cigarettes b) Somewhat less harmful than cigarettes c) About the same as cigarettes d) Somewhat more harmful than cigarettes e) Much more harmful than cigarettes f) Don t know a) Yes b) No c) Don t know a) A disposable e- cigarette or vaping device (non- All Those who respond yes to ever use question All Those who responded (a) yes to the ever use question but (b) less than daily, but at least once a week, (c) less than weekly, but at least once a month, (d) less than monthly, or (e) not at all to the frequency of use question. [Some further filtering may be needed depending on the frequency of use response option chosen and the target population.] Those who respond (a) yes to ever use question

31 Lessons learned

32 Lessons learned Assessing public health impact of a specific product, like e- cigarettes, requires: High quality scientific measurement and design Attention to the marketplace (i.e., products, marketing, manufacturers) Consideration of broader contexts of use E-cigarette surveillance would benefit from standard measures to inform and evaluate their public health impact (Pearson et al. Manuscript under review.)

33 E-cigarette Policy Research Framework Psychosocial Mediators Tobacco Control Policies Exposure to Policy Tobacco Use Behavior Outcomes Moderators

34 Thank you