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 |
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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 |
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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 |
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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) |
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Notes | No definition of abstinence provided Not clear if 'completed programme' was at 6 months |
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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. |