TY - JOUR
T1 - Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology
AU - Manzoli, Lamberto
AU - La Vecchia, Carlo
AU - Flacco, Maria Elena
AU - Capasso, Lorenzo
AU - Simonetti, Valentina
AU - Boccia, Stefania
AU - Di Baldassarre, Angela
AU - Villari, Paolo
AU - Mezzetti, Andrea
AU - Cicolini, Giancarlo
PY - 2013
Y1 - 2013
N2 - 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/designFrom 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). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable.
AB - 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/designFrom 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). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable.
KW - Cigarette smoking
KW - Cohort study
KW - Efficacy
KW - Electronic cigarette
KW - Italy
KW - Safety
KW - Cigarette smoking
KW - Cohort study
KW - Efficacy
KW - Electronic cigarette
KW - Italy
KW - Safety
UR - http://hdl.handle.net/10807/48591
U2 - 10.1186/1471-2458-13-883
DO - 10.1186/1471-2458-13-883
M3 - Article
SN - 1471-2458
VL - 13
SP - 883
EP - 883
JO - BMC Public Health
JF - BMC Public Health
ER -