Nebot 1992.
| Study characteristics | ||
| Methods | Design: cluster‐randomized controlled trial Setting: 3 urban reformed primary care centres in Barcelona, Spain Recruitment: All people who smoked (> 1 cpd) visiting physician for any reason |
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| Participants | 15 primary care teams within 3 primary care centres 425 adults who smoked, 30% F, av. age not reported, av. cpd not reported |
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| Interventions |
Intervention 1: physician counseling Participants received standard physician advice operatively defined as a personalized firm counsel to stop smoking, lasting 3 ‐ 5 minutes Intervention 2: physician counseling + nicotine gum Participants received standard physician advice plus a free supply of nicotine gum sufficient to last 2 ‐ 4 weeks Intervention 3: nurse counseling Participants received up to 15 minutes of nurse advice |
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| Outcomes | Abstinence (undefined) at 12m follow‐up Validation: Expired CO < 8 ppm |
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| Funding Source | Grant from the Fondo de Investigaciones Sanitarias de la Seguridad Social | |
| Author's declarations of interest | Not reported | |
| Notes | Strategy: Cost‐free medication + Adjunctive counseling Level: Patient Comparison types: Single component vs. standard care (testing cost‐free medications and adjunct counseling individually in separate trial arms) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Unclear risk | No details reported |
| Allocation concealment | Unclear risk | No details reported |
| Blinding of outcome assessors All outcomes | Low risk | Smoking status validated by carbon monoxide levels |
| Incomplete outcome data All outcomes | Unclear risk | Authors reported that 82% were followed up at 2 months, but they did not report the follow‐up rate at 12 months |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practice before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "The three groups had no significant differences in these characteristics except for the proportion of smokers having tried to quit before (higher among the B group patients)" |
| Adjustment for clustering in analysis? (cluster RCTs only) | High risk | None apparent |