Mejia 2015.
Study characteristics | ||
Methods | Design: Cluster‐randomized controlled trial Setting: 6 clinical systems in the cities of Buenos Aires, La Plata and Olavarria, Argentina Recruitment: Physicians were recruited from 6 clinical systems. All patients who saw their physician within 30 days of the intervention were included |
|
Participants | 254 physicians, 52.4% F 1378 patients (750 intervention, 628 control) 80.9% F, av. age not reported, av. cpd not reported |
|
Interventions | Intervention: 2 x 3‐hour training session on tobacco cessation. Physicians also received monthly emails as reminders with useful tips to help patients stop smoking or manage withdrawal Control: usual care. No further details reported |
|
Outcomes | 7‐day PPA at 12m Validation: None Quit attempts Measures of provider implementation: Ask, Advise, Assist‐Quit date, Assist‐Self‐help |
|
Funding Source | Funded by grant No.TW05935 from the Tobacco ResearchNetwork Program, Fogarty International Center, National Cancer Institute, NationalInstitute of Drug Abuse, National Institutes of Health, the National Cancer Institute for Redes en Acción (U01CA86117 and U54CA153511) and by grant No. 001726‐037 from Research on International Tobacco Control, International Development Research Center, Canada | |
Author's declarations of interest | Authored declared that they had no conflict of interest | |
Notes | Strategy: Provider training Level: Provider Comparison type: Single component vs. standard care |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Unclear risk | No details reported |
Allocation concealment | Unclear risk | No details reported |
Blinding of outcome assessors All outcomes | Unclear risk | Smoking status self‐report. Amount of face‐to‐face contact unclear |
Incomplete outcome data All outcomes | Low risk | At physician level, the overall loss to follow‐up was 30.0% (n = 76/254); 25.8% (n = 32/124) in the intervention group and 33.8% (n = 44/130) in the control group were lost to follow‐up at 12 months. At participant level, the overall loss to follow‐up was 32.3% (n = 445/1378) at 12 months and the split of this between the groups was not reported |
Recruitment bias (cluster RCTs only) | Unclear risk | QUOTE: "Lists of patients seen within 30 days after the study physicians were randomized (control) or had completed the smoking cessation course (intervention) were obtained" |
Balanced baseline characteristics? (cluster RCTs only) | Low risk | Balanced between trial arms |
Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "P values for group by time interaction are from generalised linear mixed model analysis accounting for clustering of observations by physician and repeated measures per patient" |