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. 2021 Sep 6;2021(9):CD011556. doi: 10.1002/14651858.CD011556.pub2

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
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
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
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
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"