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. 2023 Jun 19;2023(6):CD013308. doi: 10.1002/14651858.CD013308.pub2

Schuurmans 2004.

Study characteristics
Methods Study design: parallel RCT
Country: South Africa
Recruitment: community volunteers
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)
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.
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