Unrod 2007.
Study characteristics | ||
Methods | Design: Cluster‐randomized controlled trial Setting: Physicians located in the 4 largest metropolitan boroughs of New York City; Bronx, Brooklyn, Manhattan, and Queens, USA Recruitment: Facsimile invitation to physicians followed by telephone calls from a physician recruiter. Participants were recruited in physician waiting rooms |
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Participants | 518 adults who smoked, who had smoked more than 100 cigarettes in their lifetime. av. age 43, 60% M, 14 cpd | |
Interventions | Intervention: • Physicians received a 40‐minute training on brief smoking cessation counseling which followed an academic detailing approach. Physicians also received a copy of a 1‐page computerized report that characterized the participants’ smoking habit and history and offered tailored recommendations • Participants received a copy of the same computerized report that their physicians received Control: physicians were not given any training and were instructed to continue their usual smoking cessation practice. No further details reported |
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Outcomes | 7‐day PPA at 6m Validation: Salivary cotinine < 25 ng/ml Secondary outcomes: Quit attempts Measures of provider implementation: Ask, Advise, Assess, Assist‐Self‐help, Assist‐Prescribe, Arrange |
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Funding Source | The Agency for Healthcare Research and Quality | |
Author's declarations of interest | Authors declared that they had no financial conflicts of interest | |
Notes | Strategy: Provider training + Tailored print materials Level: Patient & Provider Comparison type: Multicomponent vs. standard care |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Low risk | Random‐number generator used |
Allocation concealment | Unclear risk | No details reported |
Blinding of outcome assessors All outcomes | Low risk | Smoking status validated biochemically |
Incomplete outcome data All outcomes | Low risk | At physician level, there was no loss to follow‐up at 6‐month follow‐up (0% (n = 0/70)). At participant level, the overall loss to follow‐up was 10.2% (n = 465/518); 12.2% (n = 33/270) in the intervention arm and 8.1% (n = 20/248) in the control group were lost to follow‐up at 6 months |
Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practices before randomization |
Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "Intervention and control groups did not differ on any demographic variables" |
Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "Patient 7‐day point‐prevalence abstinence was analyzed via a generalized linear model using Logit Link function, with physician as clustering variable. Mixed linear modeling, with physician as clustering variable, was used to examine longest quit attempt, number of quit attempts, and stage‐of‐change progression" |