Garvey 2012.
Methods | Study design: Randomized controlled trial Setting: Smoking cessation research clinic, Boston USA Recruitment: Community volunteers, motivated to quit |
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Participants | 278 smokers of ≥ 5 cpd. 53% women, av. age 47, av. cpd 18 | |
Interventions | Therapist: MA or BA in psychology, 3 full days training Both group received nicotine patches for 12 weeks, dose tailored to baseline smoking 1. Front‐loaded CBT‐based counselling; 2 pre‐quit and 12 post‐quit, 6 post‐quit sessions received in first 2 weeks. Pre‐quit sessions approx. 45 mins each, post‐quit 20 ‐ 30 mins. Last 3 sessions at 6 m, 9 m, 12 m 2. Weekly counselling. Same number and duration of sessions, but weekly to 12 wks |
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Outcomes | Continuous abstinence from quit date at 12 m, (never smoking for 7+ consecutive days nor for 7+ consecutive episodes and PP also reported) Validation: CO < 8 ppm |
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Notes | New for 2016 update Analysis 3, not pooled with other studies. Authors report significantly lower likelihood of relapse, using hazard ratio and continuous abstinence to define relapse. Risk ratio based on 11.7% versus 6.3% abstinent at 12 m is not significant |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Block randomization, method of sequence generation not described |
Allocation concealment (selection bias) | Unclear risk | "randomization occurred at the end of the baseline visit following the consenting process and administration of baseline measures" but no additional information |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20 (14%) front‐loaded and 16 (11.5%) weekly did not start or dropped out before quit date. Not included in denominators for MA. Later losses treated as smokers |