| Methods |
Country: USA (9 sites)
Recruitment: community volunteers (treated at smoking cessation clinics) |
| Participants |
808 unselected smokers
60% female, average age 43, average cpd 31 |
| Interventions |
1. Nicotine patch (21 mg/24 h, 6 weeks+)
2. Nicotine patch 14 mg
3. Placebo patch
Abstainers at end of week 6 entered a randomized blinded trial of weaning
Level of support: high (group therapy, 6+ sessions) |
| Outcomes |
Sustained abstinence at 6 months
Validation: CO |
| Notes |
2 trials pooled and data relating to a 7 mg patch group used in only 1 trial omitted
Long‐term (4 to 5 year) follow‐up data reported for 7/9 sites (Daughton 1999). Data not used in MA ‐ point estimate would be higher
Study was supported by Alza Corp |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated: "patients were ... randomized", but members of same household received same assignment, with one randomly selected for inclusion in the analyses |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Described as double‐blind |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "All participants were included in outcome evaluations except for the excluded members of couples (49 participants) and nine participants with major protocol infractions". Losses and withdrawals were included as treatment failures |
