Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology.
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
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). 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.


CONCLUSIONS
Data on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes.


BACKGROUND
The protocol has been registered (NCT01785537) and approved by the Ethics Committee of the University of Chieti (Record n. 6; 25-03-2013).
Department of Medicine and Aging Sciences, University of Chieti, via dei Vestini 5, 66013 Chieti, Italy. lmanzoli@post.harvard.edu.
Lamberto
L
Manzoli
Carlo
C
La Vecchia
Maria Elena
ME
Flacco
Lorenzo
L
Capasso
Valentina
V
Simonetti
Stefania
S
Boccia
Angela
A
Di Baldassarre
Paolo
P
Villari
Andrea
A
Mezzetti
Giancarlo
G
Cicolini
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D066300:Electronic Nicotine Delivery Systems / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D012107:Research Design; D016540:Smoking Cessation / Q000379:methods; D000074606:Smoking Prevention; D011795:Surveys and Questionnaires
D009538:Nicotine