Methods |
Setting: community, Spain
Recruitment: community volunteers, mainly in contemplation or preparation SoC |
Participants |
300 smokers
48% female, average age 37, average cpd 26 |
Interventions |
∙ No intervention; treatment offered after 6 months' follow‐up
∙ Standard self‐help pamphlets; 6 mailed weekly with personalised letter
∙ 2 with individual feedback based on weekly reports plus 2 additional 1‐page reports |
Outcomes |
Abstinence at 6 months or 12 months, sustained since initial quit
Validation: CO < 9 ppm |
Notes |
2 vs 1, self‐help vs control; excluded from Analysis 2.1 because of heterogeneity; quit rates 16% vs 0% at 6 months
3 vs 2, 12‐month outcome; tailored materials |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomisation method not described |
Allocation concealment (selection bias) |
Unclear risk |
No details given |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
Wait‐list control (control group participants told treatment would be delayed) |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
< 10% lost to follow‐up, included in ITT analyses |