| Methods |
Setting: family practice or pulmonary specialists, USA
Recruitment: physicians' patients wishing to use nicotine gum as a cessation aid |
| Participants |
304 smokers, 62% female, average age 42, average cpd 31 |
| Interventions |
∙ Nicotine gum (NG) and experimental self‐help materials emphasising behavioural strategies, as well as correct use of gum
∙ NG and control pamphlet Danger: The Facts About Smoking (American Cancer Society) |
| Outcomes |
Abstinence at 12 months
Validation: proportion asked to provide saliva for thiocyanate: 5 discrepant ‐ 2 self‐help, 3 control ‐ but not clear if these were at 6 months or 12 months, so self‐reported outcomes used |
| Notes |
In main comparison with advice and leaflet for control, and in comparison of NG plus self‐help vs NG alone |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomised; method not described |
| Allocation concealment (selection bias) |
Unclear risk |
No details given |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Biochemical validation conducted but not used, but similar levels of intensity and physicians blind to pamphlet condition, so differential misreport judged to be unlikely |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No mention of number lost to follow‐up |
