Methods | Setting: participants' own homes, UK Recruitment: short‐term quitters recruited from NHS Stop Smoking Clinics |
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Participants | 1404 ex‐smokers (4‐week abstinence), 702 in intervention group and 702 in control 47.3% male, average age 47, average cigarettes per day 20 |
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Interventions | 1. Relapse prevention: eight 'Forever Free' self‐help booklets by post 2. Control: single leaflet 'Learning to Stay Stopped' routinely given to NHS patients |
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Outcomes | Continuous abstinence from 2 to 12 months Validation: CO < 10 ppm at 12 months |
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Notes | Funding: "This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme" Declaration of Interest: "Paul Aveyard has done ad hoc consultancy and research for the pharmaceutical industry on smoking cessation." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple randomisation method used |
Allocation concealment (selection bias) | Unclear risk | Quote: "The participant allocation was ‘concealed’ because the recruitment of quitters occurred before the random allocation." However, it was unclear how this would achieve allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding not performed, but face‐to‐face contact was the same between the two groups, so performance bias unlikely. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemically validated abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up rates similar in both groups (intervention = 87%, control = 85%) |