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

Lee 2016.

Study characteristics
Methods Design: Cluster‐randomized controlled trial
Setting: Outpatient clinic of the Department of Family Medicine and the Health Screening Center of Seoul National University Hospital, South Korea
Recruitment: Opportunitistically in practice
Participants 414 adults who smoked, av. age 48, 92% M, av. cpd 17
Interventions Intervention: a 7‐minute long animated video containing information and options about smoking cessation. Following this, physicians gave a brief consultation about smoking problems or prescribed medications if participants asked for them
Control: routine medical care only. The participants were not provided with the decision aid, any proactive smoking cessation counseling or prescription
Outcomes PPA (undefined) at 6m
Validation: None
Measures of provider implementation: Assist‐Meds
Funding Source This work was supported by a grant for investigator‐initiated research from Pfizer (Pfizer Reference #WS2033889). None of the sponsors had a role in any aspect of the present study, including design and conduct of study; collection, management, analysis, and interpretation of the data, and preparation, review, or approval of the manuscript
Author's declarations of interest The authors declared that they had no conflict of interest and that none of the sponsors had a role in any aspect of the study
Notes Strategy: Video
Level: Patient
Comparison type: Single component vs. standard care
Risk of bias
Bias Authors' judgement Support for judgement
Sequence Generation High risk Based on the month. Exam rooms were randomized based on their number and the month (i.e. odd numbered exam rooms were intervention rooms)
Allocation concealment High risk Could have been foreseen as randomization was based on the month
Blinding of outcome assessors
All outcomes Low risk Smoking status was self‐reported. The intervention was a decision aid video so there was no person‐to‐person contact in either group
Incomplete outcome data
All outcomes High risk Attrition rates were under 50% but the difference between groups was greater than 20%. The overall loss to follow‐up was 20.5% (n = 85/414); 33.8% (n = 66/195) in the intervention group and 8.7% (n = 19/219) in the control group were lost to follow‐up at 6 months
Recruitment bias (cluster RCTs only) Low risk Participants were affiliated with the Department of Family Medicine and the Health Screening Center of Seoul National University Hospital before randomization
Balanced baseline characteristics? (cluster RCTs only) Low risk QUOTE: "None of the characteristics was significantly different between the control and intervention groups"
Adjustment for clustering in analysis? (cluster RCTs only) Low risk QUOTE: "To investigate the impact of the decision aid on the outcomes, univariate and multivariate logistic regression tests were used, with accounting for the clustering effect of nesting physicians"; "The intracluster correlation coefficient values were 0.21 for the primary outcome variable and 0.10 for the secondary outcome variable..."