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 |
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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 |
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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 |