Simon 1997.
Methods | Study design: Randomized controlled trial Setting: Veterans Administration hospital, USA Recruitment: smokers undergoing non‐cardiac surgery |
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Participants | 299 smokers (smoked within 2 wks of admission) (excl 25 deaths) 98% men, av. age 54, av. cpd 20 | |
Interventions | Therapist: public health educator 1. Multicomponent: single counselling session (30 ‐ 60 mins) prior to discharge (based on social learning theory and stages of change). Video, prescription for nicotine gum if no contraindications. 5 follow‐up counselling calls over 3 m 2. Brief counselling (10 mins) and S‐H materials |
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Outcomes | Abstinence at 12 m Validation: serum or saliva cotinine < 15 ng/ml. 6 self‐reports confirmed only by "significant other". | |
Notes | 65% of Group 1 and 17% of Group 2 reported using NRT, but use of NRT was not significantly associated with quitting in either group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Random list of assignments" |
Allocation concealment (selection bias) | Low risk | "Sealed opaque envelopes opened on formal enrollment" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 25 (8%) lost to follow‐up included in ITT analysis, 25 (8%) died, excluded from denominator |