Schuurmans 2004.
Study characteristics | ||
Methods | Study design: parallel RCT Country: South Africa Recruitment: community volunteers |
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Participants | 200 smokers 56% men, average age 43, average cigarettes per day: 23 to 26 | |
Interventions | 1) Pretreatment with nicotine patch for 2 weeks prior to quit date. Then active patch (15 mg) for 12 weeks including weaning. 4 sessions of counselling over 10 weeks 2) Pretreatment with placebo patch. Then active patch as for group 1 | |
Outcomes | Sustained abstinence at 6 months
Validation: CO < 10 ppm at each visit Adverse events: measured at all follow‐up visits to 6 months (treatment duration 12 weeks) |
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Notes | This study was supported by a grant from the Swiss Science Foundation (MMS). Conflicts of interest: Pfizer provided medication and support with data analysis. |
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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" |
Allocation concealment (selection bias) | Low risk | Quote: "Numbering of identical boxes containing patches was carried out prior to the study by a person not involved in the study" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The treatment code was broken only after the last follow‐up visit had been completed and the data recorded" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts fully recorded at all stages, ITT analyses used and participants lost to follow‐up counted as smokers |