| Methods |
Country: USA
Recruitment: community volunteers |
| Participants |
424 smokers
˜50% female, average age ˜45, average cpd ˜23 |
| Interventions |
2 x 2 factorial design, comparison between video & self‐help manuals and manuals alone collapsed
1. Nicotine patch (21 mg/24 h) for 8 weeks, 14 mg for 4 weeks, 7 mg for 4 weeks
2. Placebo patch
3. Nicotine patch and video (The video was shown at initial visit and a copy supplied for home use)
4. Placebo patch and video
Level of support: low (All treatment groups received a self‐help treatment manual designed to develop self‐regulatory skills |
| Outcomes |
Sustained abstinence at 12 months (7‐day PP at 6 and 12 months)
Validation: saliva cotinine < 20 ng/ml with the exception of participants living outside the area |
| Notes |
There was evidence of an interaction between NRT and video/self‐help conditions but this does not alter the MA so the conditions are combined from 2007. Both self‐help conditions treated as low intensity ‐ classifying video as high intensity would marginally reduce effect in high‐intensity subgroup
Study was funded by National Heart, Lung, and Blood Institute, and supported by Hoechst Marion Roussel Inc and Blue Shield Management |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Participants "were randomized to treatment conditions" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Quote: "Assignment to the patch condition was double‐blind"; participants invited to guess assignment at 6 month follow‐up |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Participants leaving the area (10) were excluded from analyses; all other unconfirmed claims of abstinence were counted as failures |
