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. 2017 Mar 31;2017(3):CD001292. doi: 10.1002/14651858.CD001292.pub3

Weissfeld 1991.

Methods Study design: Randomized controlled trial
Setting: Veterans Administration outpatient clinics, USA
 Recruitment: veterans attending walk‐in and general medicine clinics invited to attend quit smoking programme
Participants 466 male smokers
 av. age 55 years, av. cpd 26
Interventions Therapists: smoking cessation counsellors
1. Control: Pamphlet on hazards of smoking
 2. Low‐Intensity counselling: Single session 20 ‐ 30 mins and S‐H booklet
 3. High‐intensity counselling: Same initial session, with sustained contact of 3 m. 1 further face‐to‐face session, telephone calls and mailings, behavioural S‐H manual. Prescription and sample of nicotine gum and instructions for use
Outcomes Abstinence for 1 m at 6 m (9 m for high‐intensity group, 6 m after last contact)
 Validation: nicotine metabolites in urine
Notes Using validated quit rates there was no difference between 2 and 3, although self‐reported quitting was greater in 3.
 Main analysis uses 2 and 3 vs 1 with sensitivity analysis of 2 vs 1. Comparison of intensity uses 3 vs 2
 39% of group 3 used nicotine gum vs 8% and 7% in 2 and 1
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization: 2 stages; initially in 1:2 to control or intervention, then 1:1 to high or low intensity occurred after delivery of low‐intensity session.
Random number table
Allocation concealment (selection bias) Low risk Consecutively‐numbered envelopes containing treatment assignment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Biochemical validation of abstinence
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 34 (7.3%) died or lost to follow‐up included in ITT analysis. More lost in high‐intensity group