Pisinger 2010.
| Study characteristics | ||
| Methods | Design: 3‐group cluster randomized controlled trial Setting: Primary care, Denmark Recruitment: Practices recruited by mailed invitation letter. All patients seen by GP were registered |
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| Participants | 1518 adults who smoked, 62.6% F, av.age 48, 17 cpd | |
| Interventions |
Intervention 1: GPs were instructed to briefly and freely talk about smoking with all people who smoked and refer those people who were motivated to quit to a group‐based smoking cessation counseling. Intervention 2: GPs were instructed to briefly and freely talk about smoking with all people who smoked and refer all those motivated to quit to an Internet‐based smoking cessation program Control: GPs were instructed to give smoking cessation advice and assistance to quit as they used to (not necessarily to all people who were smoking). The control group did not have any special program, beyond what is known from a national survey on Danish GPs ultimo 2004. In this study, the control group only registered whether they discussed smoking with the participant or not and the time consumed by counseling |
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| Outcomes | 7‐day PPA at 12m Validation: Urinary cotinine < 200 ng/ml |
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| Funding Source | Danish Centre for Evaluation and Health and Technology Assessment | |
| Author's declarations of interest | Not reported | |
| Notes | Strategy: Adjunctive counseling + Internet program Level: Patient Component type: Single component vs. standard care (different single components tested in different intervention arms) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Sequence Generation | Low risk | QUOTE: "The GPs were pre‐randomised at the Research Centre by a computer generated list to one of the three groups" |
| Allocation concealment | Low risk | QUOTE: "The GPs were pre‐randomised at the Research Centre by a computer generated list to one of the three groups" |
| Blinding of outcome assessors All outcomes | Low risk | Smoking status biochemically validated |
| Incomplete outcome data All outcomes | High risk | Overall, 50.2% (n = 758/1518) of participants were lost to follow‐up at 12 months. No further details by group were reported |
| Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practice before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "There were no significant differences between the groups in terms of the number of patients seen or smokers included" |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | No additional effect on self‐reported 1‐year abstinence rates of either referral to group‐ based SC counseling was found in cluster analyses |