Hennrikus 2010.
Methods | Study design: Randomized controlled trial Setting: 2 medical centres; USA Recruitment: probable smokers with lower extremity PAD |
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Participants | 687 current smokers with PAD; 15% women, av. age 60, av. cpd 18 | |
Interventions | Therapists: smoking cessation counsellor 1. Verbal advice to quit from vascular provider 2. Letter from vascular provider + intensive counselling, at least 6 sessions over 5 m, first in person then phone. Information about pharmacotherapies but not provided |
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Outcomes | Abstinence at 6 m (PP) Validation: saliva cotinine < 10 ng/ml, or CO < 8 ppm for people using NRT |
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Notes | New for 2016 update High use of pharmacotherapies in both groups; 87% in I, 67% in C |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "predetermined block randomization schedule stratified by medical center" |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 25% I, 17% C lost at 6 m. 4 deaths (3I, 1C) excluded from MA denominators |