| Methods |
Setting: Community, Australia
Recruitment: Community volunteers |
| Participants |
854 smokers interested in quitting; 49% M, av. age 42, av. cigs/day 24 |
| Interventions |
1. Free 2‐week supply of nicotine patch by mail, instructed to purchase further supply. 14 or 21 mg depending on body weight
2. As 1, + 5 proactive TC sessions at 1, 2, 3, 6 and 10 weeks. 20‐min session 1, 10 mins others. Toll‐free hotline, S‐H materials |
| Outcomes |
Self‐reported abstinence at 6 m (90‐day continuous)
Validation: none, warning of CO test only |
| Notes |
TC as adjunct to NRT
Average number of calls 4.7. 9% of participants called hotline |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
"randomized" by shuffling folders each day after participants to be included were listed |
| Allocation concealment (selection bias) |
High risk |
Potential for bias, since allocation sequence not fixed in advance. Baseline characteristics similar across groups |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "To minimise misleading reports of abstinence, a bogus pipeline technique was used, with the possibility of carbon monoxide breath testing mentioned in the consent form and at the 3‐ and 6‐month monitoring calls." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
17% lost in NRT only, 15% in + counselling. Missing treated as smoking in MA |
