| Methods |
Setting: Community, Australia
Recruitment: Callers to a quitline |
| Participants |
1578 smokers; 46% M, modal age 30 ‐ 49, av. cigs/day 23 |
| Interventions |
1. Standard S‐H quit pack based around SoC
2. Additional tailored letters at baseline, and at 3 and 6 m based on mailed assessments
3. As 2, plus proactive cognitive behavioural stage‐base TC, calls at negotiated times, ˜10 ‐ 15 mins. Usually over 2 ‐ 3 weeks, could extend further.
Some participants in all groups received brief reactive counselling before enrolment |
| Outcomes |
Self‐reported abstinence at 12 m (sustained for 9 m)
Validation: none |
| Notes |
3 vs 2, sensitivity analysis 3 vs 2+1
68% received calls, av. 4.8 for those receiving any, 23% received ≥ 7 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Allocation by shuffling questionnaires |
| Allocation concealment (selection bias) |
Low risk |
Author states "no opportunity for interviewers to influence choice"; baseline characteristics balanced, likelihood of bias judged low |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
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 |
Loss to follow‐up 21% in 1, 23% in 2, 26% in 3. All participants included as smokers in the MA |
