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..." |