Methods |
Setting: 5 Veterans Administration medical centres, USA
Recruitment: By mail, planning to quit in next 30 days |
Participants |
821 smokers interested in quitting (excludes 16 deaths, 1 withdrawal); 91% M, av. age 57, av. cigs/day 26. 26% had > 7‐day abstinence in previous year, 44% ever use of bupropion, 82% ever use NRT |
Interventions |
1. Mailed S‐H and standard care; opportunity for intervention during routine health care and referral to individual or group cessation programmes. NRT and bupropion avail on formulary
2. As 1, plus proactive TC, modified California helpline protocol, 7 calls over 2 m, relapse‐sensitive schedule. NRT and bupropion available, could be mailed directly after screening and primary provider approval for bupropion |
Outcomes |
Abstinence at 12 m (sustained > 6 m, 7‐day PP also reported)
Validation: none |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomised, method not described |
Allocation concealment (selection bias) |
Unclear risk |
No details given |
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 |
Losses to follow‐up included as smokers, 16 deaths excluded |