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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 regula- tion 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 implica- tions 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 knowl- edge 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 the Food and Drug Administration and other federal research spon- sors and/or device manufacturers prioritize e-cigarette research 653
654 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES that addresses key gaps regarding harm reduction and the pub- lic 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 cigarettes: 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 depen- dence 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 risk (e.g., up until age 29), while using multiple methods to establish temporal precedence of e-cigarette use relative to smoking. o hether use of e-cigarettes with specified product charac- W teristics is associated with different risk of ever smoking 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 ran- domized controlled trials, of the effectiveness of e-cigarettes as cessation aids, using standards that have been used to evaluate smoking cessation pharmacotherapies: Â§ Trials that compare e-cigarettes to FDA-approved smok- ing cessation pharmacotherapies and other evidence-based cessation treatments are most informative. Â§ Trials could also compare the effectiveness of e-cigarettes as used in combination with existing FDA-approved ces- sation aids. Â§ 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 indi- viduals for whom tobacco smoking is especially harmful. Â§ Trials should assess adverse events in a detailed and stan- dardized manner to permit assessment of the harms of these devices compared with other smoking cessation aids.
RESEARCH NEEDS: PUBLIC HEALTH IMPLICATIONS OF E-CIGARETTES 655 Â§ Analyses should be conducted of the frequency and inten- sity of use, the reach and appeal, and the affordability and accessibility of e-cigarettes compared with other cessation treatments, and the specific product characteristics that are most closely associated with use and appeal. Â§ Trials should be conducted to compare effects of e-cigarettes Â with different product characteristics on cessation out- comes to inform product standards. Â§ the extent possible, clinical outcomes should be col- To lected 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 second- hand or thirdhand exposure to emissions of e-cigarettes. o Research to evaluate the trade-offs between effects of differ- ent product characteristics, product regulation, and policy changes on different populations, for example, 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). IMPROVING RESEARCH METHODS AND QUALITY Recommendation 20-2: The committee recommends that the Food and Drug Administration and other federal research s Âponsors 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 m Â ethods validation and development and use of appropriate study designs, 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.
656 PUBLIC HEALTH CONSEQUENCES OF E-CIGARETTES â¢ Studies that build on existing nationally representative popula- tion 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):259â269.