Simon 2003.
Methods | Study design: Randomized controlled trial Setting: Veterans Affairs hospital, USA Recruitment: Hospitalized smokers in contemplation or preparation stage of change |
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Participants | 209 smokers, 20+ cigs in total in wk before hospitalization, excludes 14 deaths during follow‐up 97% men, av. age 55, av. cpd 23 | |
Interventions | Therapists: trained nurse or public health educator 1. Intensive counselling: single counselling session (30 ‐ 60 mins) prior to discharge (based on social learning theory and stages of change), 5 telephone counselling calls < 30 mins, 1 and 3 wks, monthly for 3 m + S‐H. Recycling encouraged. Nicotine patches begun in hospital, dose‐based on pre‐hospitalization smoking rates. 2 m supply at discharge 2. Nicotine patches as 1. ˜10‐min session on risks and benefits, S‐H. |
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Outcomes | Abstinence at 12 m (7‐day PP) Validation: saliva cotinine < 15 ng/ml | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly assigned using computerized algorithm" |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 (3%) lost to follow‐up included in ITT analysis, 14 (6%) died and excluded from denominator |