NCT00534404.
Methods | Setting: USA Recruitment: Quote: "Interested individuals completed a screening survey to determine eligibility. Following study consent, participants completed two emailed surveys over the next two days and a phone confirmation call before being randomized. These check‐ins confirmed the participant had valid contact information and maintained their desire to quit smoking." | |
Participants | 2485 adult smokers of ≥ 10 cigs/day, willing to set a quit date within 2 to 4 weeks, willing to use a nicotine patch, 31% M, av. age 44. | |
Interventions | 1. NRT patch (free 8‐week) + Internet (iQuit Smoking website) 2. As 1, plus 5 sessions of TC after 0, 2, 4, 6 and 8 weeks | |
Outcomes | Self‐reported abstinence at 9 m (6 m prolonged) Validation: none | |
Notes | New for 2018 update Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information provided on ClinicalTrials.gov website |
Allocation concealment (selection bias) | Unclear risk | Insufficient information provided on ClinicalTrials.gov website |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Abstinence not biochemically validated. Level of personal contact differed between arms |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low percentage (19%) of participants lost to follow‐up and comparable across arms |