Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes:

Manzoli et al. BMC Public Health 2013, 13:883 http://www.biomedcentral.com/1471-2458/13/883 STUDY PROTOCOL Open Access Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology 1* 2,3 1 1 4Lamberto Manzoli , Carlo La Vecchia , Maria Elena Flacco , Lorenzo Capasso , Valentina Simonetti , 5 1 6 7 4Stefania Boccia , Angela Di Baldassarre , Paolo Villari , Andrea Mezzetti and Giancarlo Cicolini Abstract Background: While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety. We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking. Methods/design: From June to December 2013, we will enroll adult smokers of: (EC) e-cigarettes (self-reported inhaling ≥50 puffs per week since ≥6 months); (TC) traditional cigarettes (≥1 per day since ≥6 m); (Mixed) both electronic and traditional cigarettes (≥1 per day since ≥6 m).