Methods |
Country: UK
Recruitment: primary care (45 GPs in 11 centres) |
Participants |
836 primary care patients agreeing to try to stop smoking after brief advice from their doctor
61% female, average age 39 |
Interventions |
1. Nicotine gum (2 mg) x 6 boxes
2. Placebo gum x 6 boxes
Level of support: low (no further face‐to‐face contact, ⅔ received a letter after 1 month) |
Outcomes |
Sustained abstinence at 12 months
Validation: CO |
Notes |
Study funded by Chest, Heart and Stroke Association; discounted Nicorette gum supplied by Lunbeck, free chewing gum by Wrigleys |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "in a double‐blind random fashion". Control participants were recruited sequentially after the gum cohort had been assembled |
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 |
Unclear risk |
37% losses at 12 months |
Other bias |
Unclear risk |
Placebo gum was actually Wrigleys gum, repackaged and labelled |