Harmonizing Cigar Survey Data Across Tobacco Centers of Regulatory Science, Center for Tobacco Products, and Population Assessment of Tobacco and Health Studies: The Cigar Collaborative Research Group.

INTRODUCTION: Cigars are a popular tobacco product of choice for youth and young adults. Despite growing interest in cigar research, there are gaps in the available literature limiting an ability to set evidence-based policies. Too small research samples, the heterogeneity of types of cigars when asking a single question about use, makes analyzing data difficult. Given the Food and Drug Administration's (FDA's) authority granted in 2016 to regulate cigars, and its popularity, data to better understand use and preference for cigars will help FDA set appropriate regulatory policies. METHODS: We harmonized cigar survey data previously collected by five independent tobacco regulatory science survey research projects. Data supplying participants included three Tobacco Centers of Regulatory Science, one Center for Tobacco Products grantee, and data from Population Assessment of Tobacco and Health (PATH) study's public use dataset. RESULTS: Analyzing 92 data variables from across five studies, and applying a rigorous data harmonization protocol, we report findings on 24 key cigar use variables. The step by step protocol for harmonizing is presented. Selected findings showing strict reproducibility across all five studies reveal youth 17-19 years at highest risk for cigar initiation; relative reproducibility shows males more likely to try cigars than females but with significant differences in magnitude across studies; and areas of inconsistent reproducibility are revealed when evaluating brand preferences. CONCLUSION: Harmonizing data from multiple sources fosters a broader view of the robustness and generalizability of survey data than that from a single source. These observations raise awareness to look for the highest degree of reproducibility among and across data sources to inform policy. IMPLICATIONS: Harmonizing data from discrete datasets provides insights into cigar initiation and use and is presented showing opportunities, challenges, and solutions. Comparing observational data from PATH and four independent research studies provides a best-practices approach and example of data synthesis for the tobacco research community. The dataset of five studies offers a look at the degree of confidence in analyzing harmonized survey results. Variable conclusions raise the need to strive for the highest degree of reproducibility, to best understand the behaviors of cigar users, and allow for the future development of the most effective interventions to alter tobacco use patterns.

Systematic review of cigars, cigarillos, and little cigars among adolescents: Setting research agenda to inform tobacco control policy.

INTRODUCTION: We conducted a systematic review of the literature on cigar research on youth to identify potential future research agenda to generate evidence to inform cigar regulations to prevent cigar use among youth. METHODS: We searched articles on Medline, EMBASE, and PsycINFO in April 2017 to identify articles relevant to cigars and adolescents. Two independent coders examined 48 articles to determine eligibility: (1) published between 2000-April 2017; (2) published in English; (3) conducted in the United States; (4) published in a peer-review journal; (5) examined cigars, cigarillos, or little cigars; (6) included youth (12-18 years old); and (7) included empirical data. Three independent coders reviewed the included articles (n = 48) to identify whether the studies addressed FDA's Research Priorities. RESULTS: The studies addressed FDA's Research Priorities of "behavior" (n = 48), "communications" (n = 4), "marketing influences" (n = 1), and "impact analysis" (n = 1). Studies on "behavior" underscored the need for improvements in measurement, such as using brand names and distinguishing cigar products. The review revealed the need for restrictions on cigar flavors, development of media campaigns and interventions, increasing the cost (via taxation), and evaluating the impact of cigar policies. CONCLUSIONS: The studies mostly focused on surveillance of behaviors and use patterns, which revealed cigar specific issues to address in policies to decrease cigar use among youth. The lack of studies addressing other FDA's research priorities highlighted the critical need for future studies that inform prevention of youth cigar use.

Effectiveness of a small cash incentive on abstinence and use of cessation aids for adult smokers: A randomized controlled trial.

BACKGROUND: Large amount of financial incentive was effective to increase tobacco abstinence, but the effect of small amount is unknown. PURPOSE: We evaluated if a small amount of cash incentive (HK$500/US$64) increased abstinence, quit attempt, and use of cessation aids. METHODS: A three-armed, block randomized controlled trial recruited 1143 adult daily smokers who participated in the Hong Kong "Quit to Win" Contest. Biochemically validated quitters of the early-informed (n=379, notified about the incentive at 1-week and 1-month follow-up) and the late-informed incentive group (n=385, notified at 3-month follow-up) received the incentive at 3months. The validated quitters of the control group (n=379) received the incentive at 6months without prior notification. All subjects received brief advice, a self-help education card and a 12-page booklet. The outcomes were self-reported 7-day point prevalence of abstinence, quit attempt (intentional abstinence for at least 24h) and use of cessation aids at 3-month follow-up. RESULTS: By intention-to-treat, the early-informed group at 3-month follow-up reported a higher rate of quit attempt (no smoking for at least 24h) than the other 2 groups (44.1% vs. 37.4%, Odds ratio (OR)=1.32, 95% CI 1.03-1.69, p=0.03), but they had similar abstinence (9.2% vs. 9.7%, OR=0.95, 95% CI 0.62, 1.45). The early- and late-informed group showed similar quitting outcomes. The early-informed group reported more quit attempts by reading self-help materials than the other 2 groups (31.4% vs. 25.3%, OR=1.56, 95% CI 1.12-2.18, p<0.01). CONCLUSIONS: The small cash incentive with early notification increased quit attempt by "self-directed help" but not abstinence. Future financial incentive-based programmes with a larger incentive, accessible quitting resources and encouragement of using existing smoking cessation services are needed.