Hajek 2015a.
Study characteristics | ||
Methods | Design: Prospective cohort, intervention provided Recruitment: People who smoke attending stop‐smoking service Study start date: March 2014; Study end date: March 2015 Setting: Stop‐smoking service, London, UK |
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Participants | Total N: 100 (69 of whom accepted offer of EC) Inclusion criteria:
38% women (those who accepted) 55% women (those who declined), mean age 41, mean cpd 14, all motivated to quit. EC use at baseline not specified but some who declined EC offer had used EC in the past Motivated to quit: Yes E‐cigarette use at baseline: Not specified |
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Interventions |
EC: Cig‐a‐like and refillable EC: offered to all people who smoke joining service; offered choice of ‘cig‐a‐like’ (Gamucci, 1.6% or 2.2% nicotine per ml) product or tank model (EVOD, 1.8%; later replaced with Aspire product due to leakage issues). 69% of those offered received an EC on TQD Medication: Offered stop‐smoking medications including NRT and varenicline as in standard protocol. Of EC users 33% opted to also use NRT, 29% varenicline, 38% nothing Support: weekly, as in standard protocol |
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Outcomes | Adverse events collected throughout, method for collection unclear Also collected: 4‐week biochemically‐validated abstinence, participant feedback, cost |
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Study funding | "The pilot study was sponsored by City of London Corporation." | |
Author declarations | "Peter Hajek received research funds from and provided consultancy to manufacturers of smoking cessation medications. The remaining authors have no conflicts of interest to declare." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Not randomized |
Allocation concealment (selection bias) | High risk | Not randomized |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 26% lost in EC group, dropout rate in EC decliners not reported. Reasons for dropout not stated |
Selective reporting (reporting bias) | Unclear risk | Unclear which outcomes authors set out to collect, no protocol available |