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20 Research Needs: Public Health Implications of E-Cigarettes The committee was tasked to provide a list of research needs to inform Food and Drug Administration (FDA) and e-cigarette regulation that will be prioritized with respect to: â¢ Research to gather information of most importance for the regulation of electronic cigarettes to protect the population health â¢ Research that should be a priority for federal funding The committee identified many gaps in the literature during its review and identified dozens of important specific research needs for understanding the harm reduction potential and public health implications of e-cigarettes, as other research groups have documented (Walton et al., 2015). As described in Chapters 6 and 15, the committee identified two overarching research needs: addressing gaps in substantive knowledge and improving research methods and quality. Specific items for consideration identified by the committee are noted for each of these and appear in approximately the order in which the underlying research need emerged within Section III. ADDRESSING GAPS IN SUBSTANTIVE KNOWLEDGE Recommendation 20-1: The committee recommends that FDA and other federal research sponsors and/or device manufacturers prioritize e-cigarette research that addresses key gaps regarding harm reduction and the public health implications of e-cigarettes. This might include rapid response funding opportunities. Specific items for consideration follow. â¢ Potential of e-cigarettes to influence the ever use of combustible tobacco use: o Research that addresses potential doseâresponse associations between e- cigarette use and combustible tobacco cigarette smoking in adolescents and young adults, including detailed assessment of the use frequency and intensity, and dependence symptoms, for both products. o Studies that follow an entire population of youth beginning at an age in which risk of use of any product is negligible (e.g., 10 years old) and investigate time varying associations between e-cigarette use and later combustible tobacco cigarette use at multiple developmental stages throughout the entire period of 20-1 PREPUBLICATION COPY: UNCORRECTED PROOFS
20-2 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES risk (e.g., up until age 29), while using multiple methods to establish temporal precedence of vaping relative to smoking. o Whether use of e-cigarettes with specified product characteristics is associated with different risk of smoking ever use and progression to inform product standard. â¢ Potential of e-cigarettes to promote smoking cessation and/or harm reduction: o Carefully designed studies, especially adequately powered randomized controlled trials, of the effectiveness of e-cigarettes as cessation aids, using standards that have been used to evaluate smoking cessation pharmacotherapies: Trials that compare e-cigarettes to FDA-approved smoking cessation pharmacotherapies and other evidence-based cessation treatments are most informative. Trials could also compare the effectiveness of e-cigarettes as used in combination with existing FDA-approved cessation aids. Trials should be conducted not only in general populations of smokers, but also among subgroups of smokers with higher smoking rates, among smokers less likely to use or respond to existing cessation treatments, and among individuals for whom tobacco smoking is especially harmful. Trials should assess adverse events in a detailed and standardized manner to permit assessment of the harms of these devices compared with other smoking cessation aids. Analyses of the frequency and intensity of use, the reach and appeal, and affordability and accessibility of e-cigarettes compared with other cessation treatments, and the specific product characteristics that most closely associate with use and appeal. Trials comparing e-cigarettes with different product characteristics on cessation outcomes to inform product standards. To the extent possible, clinical outcomes should be collected in these trials, in addition to the primary outcome, tobacco cessation. o Research to develop effective communication strategies about the relative risk of e-cigarettes compared with combustible tobacco cigarettes. o Research on potential harm reduction to bystanders exposed involuntarily to tobacco smoke after secondhand or thirdhand exposure to combustible tobacco smoke is replaced by secondhand or thirdhand exposure to emissions of e-cigarettes. o Research to evaluate the trade-offs between effects of different product characteristics, product regulation, and policy changes on different populations, e.g. increases in youth ever use versus adult cessation. o Research on the mechanisms through which e-cigarette use affects combustible tobacco cigarette smoking (both ever use among youth, and quitting among current tobacco cigarette smokers). PREPUBLICATION COPY: UNCORRECTED PROOFS
RESEARCH NEEDS: PUBLIC HEALTH IMPLICATIONS OF E-CIGARETTES 20-3 IMPROVE RESEARCH METHODS AND QUALITY Recommendation 20-2: The committee recommends that FDA and other federal research sponsors and/or device manufacturers prioritize research on the public health implications of e-cigarettes that improves the quality of e- cigarette research. This includes protocol and methods validation and development and use of appropriate study design, including the use of appropriate control groups. â¢ Prospective observational studies to assess the association of e-cigarettes with smoking cessation that include careful, detailed assessment of factors that existing research suggests may be important to moderate the effect of e-cigarettes on cessation, including frequency and duration of use as well as nicotine dependence, reason for use, and intention to quit. â¢ Studies that build on existing nationally representative population surveys of adults to monitor patterns of e-cigarette use in detail on an ongoing basis to include characterization of patterns of e-cigarette use such as the frequency and duration of use, type of device used, and reason for use. REFERENCE Walton, K. M., D. B. Abrams, W. C. Bailey, D. Clark, G. N. Connolly, M. V. Djordjevic, T. E. Eissenberg, M. C. Fiore, M. L. Goniewicz, L. Haverkos, S. S. Hecht, J. E. Henningfield, J. R. Hughes, C. A. Oncken, L. Postow, J. E. Rose, K. L. Wanke, L. Yang, and D. K. Hatsukami. 2015. NIH electronic cigarette workshop: Developing a research agenda. Nicotine & Tobacco Research 17(2):259-269. PREPUBLICATION COPY: UNCORRECTED PROOFS