Williams 2006.
Study characteristics | ||
Methods | Randomised controlled trial, parallel group (7:3) | |
Participants | Inclusion criteria: adult smokers who smoked > 5 cigarettes/day Exclusion criteria: history of psychotic illness, unable to read/speak English, minimum life expectancy of 18 months Total randomised: 1006 participants (n = 714 intervention group, n = 292 comparison group) Mean age: 46 years, 64% women, 82% white |
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Interventions | Intervention group: multifaceted intervention
Counselors were trained to support participants in making clear and autonomous choices and goal‐setting. Comparison group: received booklets on smoking cessation and healthy diet; also encouraged to enrol in a smoking cessation programme and to meet with their physician |
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Outcomes | Primary outcome: 12‐month prolonged tobacco abstinence Secondary outcomes: change in percent calories from fat, LDL‐C from baseline to 18 months Total analysed: same as above (ITT analysis) Follow‐up: 18 months |
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Study funding sources | National Institute of Mental Health, USA; National Cancer Institute, USA | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation not reported |
Allocation concealment (selection bias) | Low risk | "The results of a stratified permutated blocked randomization were placed in numbered double‐sealed security envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel not blinded to treatment assignment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcomes |
Incomplete outcome data (attrition bias) All outcomes | High risk | 28% loss to follow‐up at 18 months; ITT analysis reported by authors but analyses appear to be completers analysis for LDL |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes all reported |
Other bias | Unclear risk | Received funding from pharmaceutical industry |