Methods | Design: Prospective cohort Recruitment: advertisements in free London newspapers Setting: Smokers' clinic, East London, UK Inclusion criteria: Daily smokers who want to quit, aged 18 and older Exclusion criteria: pregnant and breastfeeding women, current serious medical illness, EC use for more than 1 week in the past |
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Participants | Total N: 40 45% women, mean age 47 (SD 12), mean cpd 19 (SD 10), mean FTND 5.2 (SD 2.8), 65% in full‐time employment |
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Interventions | Participants attended baseline session 1 week prior to their TQD. On the TQD, participants were provided with an EC (Green Smoke, 1st generation device, 2.4% nicotine cartridges). 2 cartridges per day were supplied initially, with the supply adjusted to actual use later. Attended 4 weekly follow‐up sessions and received standard behavioural support | |
Outcomes | Cigarette consumption and CO readings collected at each session. Urine sample for cotinine and 3‐HPMA analysis collected at baseline and 4 weeks post‐TQD Change in urinary 3‐HPMA (ng/mg creatinine) at 4 weeks Change in urinary cotinine (ng/mg creatinine) at 4 weeks Change in CO at 4 weeks |
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Notes | Previously McRobbie 2014, ID updated in this version to reflect 2015 publication | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Prospective cohort |
Allocation concealment (selection bias) | High risk | Not randomized |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation used |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7/40 participants were lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All predefined outcomes reported |