Killen 1997.
Methods | Setting: community, USA Recruitment: advertisements | |
Participants | 424 smokers, 50% female, average age 42 to 47 years, average cpd 24 | |
Interventions | 2 × 2 factorial design. All participants received self‐help materials designed to help develop self‐control skills ∙ Self‐help and placebo patch ∙ Self‐help and nicotine patch (21 mg) ∙ As first bullet above and video, watched during initial office visit, and for use at home ∙ As second bullet above and video | |
Outcomes | Sustained abstinence (6 months and 12 months) Validation: saliva cotinine < 20 ng/mL | |
Notes | Test of additional materials With evidence of an interaction between nicotine and video conditions, nicotine arms entered separately via a dummy study |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised in a 2 × 2 fully crossed factorial design; method not described |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear if participants not receiving video knew other participants were receiving it (and viewing it in a group); biochemical validation used |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number lost to follow‐up not specified, but all participants included in denominators |