| Methods |
Setting: General practice, Australia
Recruitment: 45 participating GPs recruiting patients who smoked |
| Participants |
1039 smokers, not selected for motivation but ˜80% had previously tried to quit; 45% M, av. age: 41, av. cigs/day 17 |
| Interventions |
1. Referral: Smokers with any interest in quitting referred by fax to Victorian Quitline. Proactive contact attempted with up to 2 pre‐quit and 4 post‐quit sessions typically using relapse‐sensitive schedule. Internet support available as an alternative (4.4% reported use)
2. In‐practice support, could include external referral if this was clinical preference
All participants given guideline‐based assessment of readiness to quit and offer of pharmacotherapy if appropriate |
| Outcomes |
Self‐reported abstinence at 12 m (sustained ≥ 10 m)
Validation: none |
| Notes |
TC as adjunct to face‐to‐face intervention. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Cluster‐randomised by GP (1:2 ratio). Computer allocation before GPs attended education session for their assigned intervention |
| Allocation concealment (selection bias) |
Unclear risk |
Initially concealed but 13 referral (30%) and 11 (42%) control GPs failed to recruit participants. Allocation not blind at time of recruitment of individual participants, so further selection bias possible. Measured characteristics at baseline were similar |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "Three‐ and 12‐month questionnaires were administered...by trained interviewers who were blind to treatment condition until after the outcome data were collected." However, reliant on self‐reported outcomes from participants not blinded to treatment condition. Level of personal contact differed between arms |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
33% lost in referral condition, 39% in control, all included as smokers in MA. Excluding losses does not affect MA |
