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. 2021 Sep 14;2021(9):CD010216. doi: 10.1002/14651858.CD010216.pub6

McRobbie 2015.

Study characteristics
Methods Design: Prospective cohort
Recruitment: advertisements in free London newspapers
Setting: Smokers' clinic, East London, UK
Study start date: February 2013; Study end date: September 2013
Participants Total N: 40
Inclusion criteria:
  • People who smoke daily 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


45% women, mean age 47 (SD 12), mean cpd 19 (SD 10), mean FTND 5.2 (SD 2.8), 65% in full‐time employment
Motivated to quit: Yes
E‐cigarette use at baseline: Excluded those who had used EC for more than 1 week in the past
Interventions EC: Cig‐a‐like
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 a day were supplied initially, with the supply adjusted to actual use later. Attended 4 weekly follow‐up sessions and received standard behavioral 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
Study funding "This study was funded by a grant given to P. Hajek, H. McRobbie, and M.L.Goniewicz from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with 18 U.S.C. Section 1734 solely to indicate this fact."
Author declarations "H. McRobbie is Clincal Director at The Dragon Institute; reports receiving commercial research grant from Pfizer; and has received speakers bureau honoraria from Johnson&Johnson and Pfizer. M.L. Goniewicz reports receiving commercial research grant from Pfizer. P. Hajek has received speakers bureau honoraria from and is a consultant/advisory board member for the manufacturers of stop‐smoking medications. No potential conflicts of interest were disclosed by the other authors."
Notes  
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
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