Aveyard 2003.
Study characteristics | ||
Methods | Design: 4‐group randomized controlled trial Setting: General practices in West Midlands, UK Recruitment: Mailed invitations to patients of general practices. |
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Participants | 65 practices 2471 people who smoked, 55% F, av.age 41, 20 cpd |
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Interventions | Intervention 1: participants received self help workbook and three tailored letters Intervention 2: patients received self‐help workbook, three tailored letters, and three telephone calls Intervention 3: patients received self‐help workbook, three tailored letters, and three appointments with a nurse Control: patients received four standard items of self‐help materials |
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Outcomes | 6m sustained abstinence at 12m Validation: Salivary cotinine <14.2 ng/ml |
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Funding Source | The health authorities of the West Midlands | |
Author's declarations of interest | Not reported. | |
Notes | Strategy: Adjunctive counseling + Tailored print materials Level: Patient Comparison type: 1) Single component vs. standard care; 2) multicomponent vs. standard care; 3) active vs. active |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Unclear risk | No details reported |
Allocation concealment | Low risk | QUOTE: "Questionnaires were read optically and the data transferred automatically to the Access database that performed the minimization and controlled the contacts. There was no reason and no way that the clerical assistant running the database could alter the questionnaire reading schedule, which would have altered the allocation of particular individuals" |
Blinding of outcome assessors All outcomes | Low risk | Smoking abstinence was biochemically validated |
Incomplete outcome data All outcomes | Low risk | The overall loss to follow‐up was 39.7% (n = 981/2471); 40.0% (n = 273/683) in the manual group, 43.6% (n = 299/685) in the phone group, 49.2% (n = 203/413) in the nurse group, and 29.9% (n = 206/690) in the control group were lost to follow‐up at 12 months |