Aveyard 2007.
Methods | Study design: Randomized controlled trial Setting: 26 general practices (primary care clinics), UK Recruitment: 92% volunteers in response to mailings |
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Participants | 925 smokers 51% women, av. age 43, 50% smoked 11 ‐ 20 cpd | |
Interventions | Therapists: Practice nurses trained to provide cessation support and manage NRT Both interventions included 8 wks of 16 mg nicotine patch 1. Basic support; 1 visit (20 ‐ 40 mins) before quit attempt, phone call on TQD, visits/phone calls at 7 ‐ 14 days and at 21 ‐ 28 days (10 ‐ 20 mins) 2. Weekly support; as 1. plus additional call at 10 days and visits at 14 and 21 days |
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Outcomes | Abstinence at 12 m (sustained at 1, 4, 12, 26 wks) Validation: CO < 10 ppm at treatment visits, saliva cotinine < 15 ng/ml at follow‐ups | |
Notes | Not in main analysis; compares higher and lower intensity counselling. Therapists were not full‐time specialist counsellors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random‐number generator |
Allocation concealment (selection bias) | Low risk | Numbered sealed envelopes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence; staff making follow‐up calls were blind |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 288 (31%) lost to follow‐up, similar across groups, included in ITT analysis |