Tønnesen 2000.
Study characteristics | ||
Methods | Study design: parallel RCT Country: Denmark Recruitment: referrals to lung clinic |
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Participants | 446 smokers ≥ 10 cigarettes per day 48% men, average age 49, average cigarettes per day 18 | |
Interventions | 1) 5 mg nicotine patch (placebo) 2) 15 mg (16‐hour) nicotine patch for 12 weeks (up to 9 months on request) 3) Nicotine inhaler (4 to 12/day ad lib) 4) Combination, 15 mg patch and inhaler | |
Outcomes | Sustained abstinence at 12 months, (from week 2, paper also reports PPA and with slips rates)
Validation: CO < 10 ppm at all visits Adverse events: measured at every follow‐up to 12 months (note: treatment could continue to 12 months) |
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Notes | This study was supported by a grant from Pharmacia & Upjohn, Helsingborg, Sweden and the Danish Lung Foundation. Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a computer‐generated list with random numbers" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not used ‐ open‐label trial |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Non‐attenders or lost to follow‐up were included as smokers |