Methods |
Setting: Community, USA
Recruitment: Advertisements for volunteers to test S‐H materials, not selected for motivation |
Participants |
756 smokers (12% precontemplation, 58% contemplation, 30% preparation) (378 in relevant arms); 38% M, av. age 43, av. cigs/day 27 |
Interventions |
1. ALA S‐H manuals
2. Tailored manuals ‐ 5 covering precontemplation, contemplation, action, maintenance, relapse. Participants sent manual for their SoC and subsequent ones
3. Interactive ‐ in addition to tailored manuals, sent personally‐tailored reports in response to questionnaires
4. Proactive TC ‐ short (15‐min) calls at 0, 1 m, 3 m, 6 m. Materials as in 3 |
Outcomes |
Self‐reported abstinence at 18 m (sustained at 12 m and 18 m)
Validation: none. Participants asked for names of significant others but these not contacted |
Notes |
Arms 4 vs 3, TC vs S‐H alone. Numbers randomised to groups and quit rates as shown in graphs obtained from authors |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomised, method not described, stratified by SoC |
Allocation concealment (selection bias) |
Unclear risk |
No details given |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
'Bogus pipeline' approach; names of significant others asked for but not contacted |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Attrition at each assessment averaged 4.1% ‐ 7.1% across all treatment conditions, not significantly different. 70% provided data at every assessment. MA uses numbers randomised, sensitivity analysis does not alter conclusions |