| Methods |
Setting: Community, USA
Recruitment: Proactive approach to smokers at Veterans Administration Medical Centre. Passive consent by mail then phone screening, not selected for motivation |
| Participants |
2054 smokers (1009 in relevant arms); 76% M, av. age 51, 40% precontemplators, 40% contemplators, 20% preparers |
| Interventions |
1. Stage‐based S‐H manuals; participants sent manual for current stage and next stage. (not used in this review)
2. As 1, plus 6‐week nicotine patch if in appropriate stage, reassessed for NRT eligibility at 6 and 10 m (not used in this review)
3. As 2, plus 1 expert system written feedback report
4. As 3, plus regular automated TC (pre‐recorded voice files tailored to responses). People receiving NRT had weekly calls in month 1, biweekly in month 2, then monthly to month 6. People not receiving NRT had monthly calls. Participants could also initiate calls |
| Outcomes |
Self‐reported abstinence at 30 m (sustained for 6 m)
Validation: none |
| Notes |
Comparison of arms 4 vs 3 for proactive TC. In NRT eligible groups 350 (67%) received NRT at baseline and 448 (86%) received NRT at some point, so classified as adjunct to pharmacotherapy, and in > 6 call category |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐based random‐number generator |
| Allocation concealment (selection bias) |
Low risk |
Allocation done after completion of survey. randomised participants who did not return consent form are excluded from further analyses |
| 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 |
39% lost includes 8% refused by 30 m, no significant differences between groups. Different treatments of missing data reported not to have altered pattern of results |
