Cummings 1989a.
Study characteristics | ||
Methods | Design: Cluster‐randomized controlled trial Setting: Private practices of internal medicine and family practice, USA Recruitment: Patients were recruited by primary care staff, or by research staff in clinics |
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Participants | 916 adult who smoked (446 control, 470 intervention). 56% F, 20 cpd, av.age 44 | |
Interventions | Intervention: • Physicians received training on smoking cessation counseling in 3 x 1‐hour seminars • Practices were provided with free self‐help materials, stickers, quit date prescription pads, and posters. Nurses and office staff were coached on the program and supporting materials by a member of the research staff Control: usual care. No further description on what the usual care entailed was reported |
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Outcomes | Continuous abstinence at 12m Validation: CO levels (cut‐off not defined), salivary cotinine < 30 ng/ml Quit attempts Measures of provider implementation: Ask, Assist‐Self‐help, Assist‐Quit date, Assist‐Meds, Arrange |
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Funding Source | Grant # CA38337 from the National Cancer Institute and by the Henry J. Kaiser Foundation Faculty Fellowship in General Internal Medicine (SRC). | |
Author's declarations of interest | Not reported. | |
Notes | Strategy: Provider training + Outreach facilitation Level: Provider + Practice Comparison type: Multicomponent vs. standard care |
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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 | Low risk | Smoking status was biochemically validated |
Incomplete outcome data All outcomes | Low risk | Attrition rates were under 50% and the difference between groups was less than 20%. The overall loss to follow‐up was 22.7% (n = 208/916 survivors); 24.9% (n = 117/470 survivors) in the intervention group and 20.4% (n = 91/446) in the control group were lost to follow‐up at 1 year |
Recruitment bias (cluster RCTs only) | Low risk | Participants were affiliated with the practice before randomization |
Balanced baseline characteristics? (cluster RCTs only) | Low risk | Balanced between arms |
Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "Individual patients were the units of analysis for the results we are presenting. A few physicians were clustered by offices and patients were clustered by physician. We tested the effect of this clustering in other analyses in which the sampling variances were adjusted for cluster sampling. These adjustments had no discernible effect on significance levels and did not alter our conclusions. We also analysed our results using the physician as the unit of analysis... These results were similar to the results of the analyses in which patients were the units of analysis. Thus, we omitted them to simplify the presentation" |