Richmond 1993.
Study characteristics | ||
Methods | Design: Randomized controlled trial with 3 active trial arms Setting: GPs in Sydney, Australia Recruitment: GPs invited their patients to participate. |
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Participants | 450 adults who smoked (16 ‐ 65 years) free from any condition which was contraindicated for the use of nicotine gum. 60% F, av.age 35, 22 cpd | |
Interventions |
Intervention 1: Participant saw GP at baseline, 1w, 3w, 3m, 6m and received comprehensive counseling from GP on how to quit smoking Intervention 2: Participant saw GP at baseline, 1w, 3w, 3m, 6m and received comprehensive counseling from GP on how to quit smoking Participants were given a supply of nicotine gum, an explanation of its use, and an instruction booklet Intervention 3: Participants attended a baseline visit and follow‐up visits at 3m and 6m. At at baseline participants were advised to quit by GP and given a supply of nicotine gum, an explanation of its use, and an instruction booklet |
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Outcomes | PPA at 12m Continuous abstinence at 12m Validation: None |
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Funding Source | Funded by the Department of Health, Housing and Community Services, Community Health Anti‐Tuberculosis Association, Glaxo Australia, and the Drug and Alcohol Directorate, NSW Department of Health | |
Author's declarations of interest | Not reported | |
Notes | Strategy: Cost‐free medications, adjunctive counseling Level: Patient Type: Active vs. active (isolates cost‐free medications) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | High risk | All participants were allocated according to random weekly assignment to 1 of 3 intervention groups |
Allocation concealment | High risk | Weekly allocation. Could have been foreseen |
Blinding of outcome assessors All outcomes | High risk | Smoking status was self‐reported, and different contact between groups |
Incomplete outcome data All outcomes | Unclear risk | QUOTE: "a number of patients who were out of contact were eliminated from the predictor analyses...and 12 month follow‐ups (n = 59, 13%)"; "After the initial consultation, 15‐25% of the patients on each occasion did not attend the session and could not be contacted". No further details reported |