Yano 2008.
| Study characteristics | ||
| Methods | Design: Cluster‐randomized controlled trial Setting: Veterans Health Administration (VA) primary care practices across 5 southwestern states, USA Recruitment: All eligible practices within the Veterans Health Administation were approached |
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| Participants | 1941 primary care patients who were currently smoking, av.age 57, 94% M, av. cpd not reported | |
| Interventions | Intervention: Each intervention practice received the following: ‐ 30‐minute didactic sessions on population‐based smoking cessation ‐ Implementation planning ‐ Evidence summaries ‐ Recommendations for minimum protocols and implementation strategies ‐ Smoking cessation resource materials and tools for participants and providers ‐ Quality improvement manual outlining intervention processes and linking sites with research team assistance ‐ Monthly audio or video conferences with site leadership to facilitate ongoing local adaptation of the prioritized interventions ‐ Bimonthly newsletters highlighting practice successes and challenges among participating sites ‐ Quarterly audit‐and‐feedback progress reports Control: sites received guideline copies and audit‐feedback reports from externally‐audited random patient records |
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| Outcomes | 30 day PPA at 12m Validation: None Measures of provider implementation: Advise, Arrange |
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| Funding Source | Funded by the VAHSR&D Service | |
| Author's declarations of interest | QUOTE: "The authors have no relevant financial interests or advocacy positions pertaining to this manuscript. VA policy requires submission of a copy of manuscripts on acceptance for internal preparation of briefings and/or press release as needed in anticipation of publication, but they do not undergo or require internal peer review or comment periods..." | |
| Notes | Strategy: Outreach facilitation + Audit & feedback + Provider training Level: Provider + Practice Comparison type: Multi‐component 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 self‐report, but contact did not differ between arms |
| Incomplete outcome data All outcomes | Low risk | At participant level, the overall loss to follow‐up was 44.4% (n = 861/1941); 44.3% (n = 410/925) in the intervention group and 44.4% (n = 451/1016) in the control group were lost to follow‐up at 12 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: "We found no baseline differences in sociodemographics, health habits, readiness to change, or primary care visits. Control site patients were more likely to smoke everyday (p<0.01), wake up to smoke (p<0.05), and to have tried nicotine patches (p<0.01), attended a smoking cessation program (p<0.0001), and tried other ways to quit preintervention (p<0.05)...". Authors report adjusting for baseline differences in their analyses. |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "We assessed the intraclass correlation coefficient to determine the need for cluster adjustment; because the intraclass correlation coefficient was not statistically significant from zero, an unadjusted analytic approach was used" |