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. 2016 Sep 13;2016(9):CD010216. doi: 10.1002/14651858.CD010216.pub3
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
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
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
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