| Methods |
Country: USA, multicentre trial
Recruitment: 10 Veterans Affairs Medical Centers |
| Participants |
584 smokers (> 15 cpd) with a history of cardiac disease. Patients with cardiac events within the last 2 weeks were excluded |
| Interventions |
1. Nicotine patch, (21 mg/24 h for 6 weeks, 14 mg for 2 weeks, 7 mg for 2 weeks)
2. Placebo patch
Level of support: High (self‐help pamphlets and brief behavioural counselling on 3 occasions) |
| Outcomes |
PP abstinence at 6 months (Joseph 1996), 12 months (Joseph 1999)
Validation: CO ≤ 10 ppm |
| Notes |
Study was funded by Hoechst Marion Roussel |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "a computer‐generated schedule" at the Minneapolis VAMC Co‐ordinating Center |
| Allocation concealment (selection bias) |
Unclear risk |
Participants were randomly assigned in blocks of 10 |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Described as double‐blind, but no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Losses and withdrawals fully reported, as primary and secondary endpoints |
