Rigotti 1997.
Methods | Study design: Randomized controlled trial Setting: Hospital, USA Recruitment: Inpatients in medical or surgical services, smoking > 1 cig in month before admission |
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Participants | 615 smokers or recent quitters (excluding 35 deaths). 37% of intervention and 32% of controls had a current smoking‐related health problem | |
Interventions | Therapist: research assistant supervised by a nurse 1. Usual care 2. Single bedside counselling session (motivational interviewing, cognitive behavioural and relapse prevention techniques), av. 15 mins, S‐H materials, chart prompts, 1 ‐ 3 telephone calls post‐discharge |
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Outcomes | Abstinence at 6 m (PP, sustained abstinence reported based on self‐report) Validation: saliva cotinine for people living in Mass (85% of quitters) | |
Notes | Use of validated PP rather than sustained abstinence gives more conservative treatment effect | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Each day's list of eligible smokers put in random order and participants recruited consecutively in this order. Randomized by research assistant |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence for majority |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 73 (22.4%) lost to follow‐up included in ITT analysis, no evidence of differential loss. 35 (5.4%) deaths excluded |