Reid 1999.
Methods | Setting: community, Canada Recruitment: volunteers | |
Participants | 396 smokers interested in quitting within 30 days, smoking ≥ 15 cpd; 48% F, av age 38, av cpd 23 to 24 | |
Interventions | Pharmacotherapy: NRT; patch (15 mg x 8 wks, 10 mg x 2 weeks, 5 mg x 2 weeks) free 1. Physician advice (3 x 15‐min, 2 weeks before, 4 weeks, 12 weeks after quit date) 2. As 1, plus telephone calls from nurse counsellors, x 3 at 2, 6, 13 weeks |
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Outcomes | Abstinence at 12 m (PP) Validation: CO, but self‐reported rates reported. Only 1 disconfirmation | |
Source of Funding/CoI | National Cancer Institute of Canada with funds from the Canadian Cancer Society Nicotine replacement therapy was provided at no cost by McNeil Consumer Products. "The University of Ottawa Heart Institute Research Corporation has a contract with Johnson & Johnson–Merck Consumer Pharmaceuticals to manage the 'Stop Smoking Now!' telephone counselling service offered to users of Nicotrol NRT. The authors received a grant from Johnson & Johnson–Merck to conduct a pilot study before the clinical trial; no payment was received from the company for the clinical trial or its analysis and write‐up." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised using table of random numbers, stratified by sex and nicotine dependence |
Allocation concealment (selection bias) | Unclear risk | Concealment unclear but physician blind to allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 84% intervention, 86% control, followed up at 12 m |