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. 2016 Sep 13;2016(9):CD010216. doi: 10.1002/14651858.CD010216.pub3
Methods Design: Prospective cohort
Recruitment: Letter sent to family practice patients who were current smokers
Setting: Single family practice, Colorado USA
Inclusion criteria: Want to quit or switch from tobacco cigarettes to ECs
Exclusion criteria: None reported
Participants Letters sent to 640 patients, 48 chose to participate and 44 completed the programme, 4 were lost to follow‐up
Of the 44 participants, 66% women, all non‐Hispanic/white, aged 20 ‐ 75 (30% were age 51 ‐ 60), 57% had a high school education or less
Interventions The 6‐month smoking cessation programme was based on The '5 A's' model and transtheoretical model. Options for treatment were discussed with each participant at the start of the programme. All used an EC, with 16 using bupropion and 2 using varenicline as well
Participants were provided with written information on “blu cig” and “smoke tip” ECs, regarding cost, availability, nicotine dosage options
Outcomes Phone follow‐ups at 2 weeks, 1 month, 3 months, and 6 months
At completion of programme (using ITT)
Abstinence from smoking and EC use
Abstinence from smoking but not EC use
≥ 50% reduction of baseline cigarette consumption (still using ECs)
Notes No definition of abstinence provided
Not clear if 'completed programme' was at 6 months
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 High risk No blinding
Incomplete outcome data (attrition bias) All outcomes Low risk 4/48 lost to follow‐up
Selective reporting (reporting bias) Unclear risk Unable to determine prespecified outcomes
Other bias High risk No definition of abstinence provided
Not clear if 'completed programme' was at 6 months.