Meyer 2012.
| Study characteristics | ||
| Methods | Design: Clustered randomized controlled trial with 3 active comparators Setting: Primary care in North‐Eastern Germany Recruitment: Practices contacted by research team and invited to participate |
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| Participants | 151 practices 3086 participants, 43% F, av.age 40, av. cpd not reported |
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| Interventions |
Intervention 1: brief advice with desktop resource Participants received a 10‐minute brief advice which incorporated elements of health behavior change counseling and were provided with self‐help materials. Physicians received a summary sheet of smoking‐related characteristics to prompt counseling and also a desktop resource with a flow chart illustrating the elements of counseling and general communication strategies Intervention 2: tailored letters Participants received 2 tailored letters, based on their answers to 2 questionnaires. Letters were given while participant was in the practice Intervention 3: combination Participants received both brief advice from the physician and a tailored letter. The same self‐help manuals used in the other conditions were provided to the participants |
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| Outcomes | 6m prolonged abstinence at 12m Validation: None Provided some data on intervention 'reach' but it was not possible to classify this into our provider implementation outcomes |
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| Funding Source | The German Federal Ministry of Research and EducationThe Social Ministry of the State of Mecklenburg‐Vorpommern The German Research Foundation | |
| Author's declarations of interest | Authors declared that they had no conflict of interest | |
| Notes | Strategy: Tailored materials, flow sheet Level: Patient, practice Comparison type: Active vs. active (2 comparisons: int 1 vs. int 3 & int 2 vs. intervention 3) |
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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 | High risk | Smoking status self‐report, and contact differed between trial arms |
| Incomplete outcome data All outcomes | Low risk | Attrition rates were under 50% and the difference among groups was less than 20%. At practice level, no practice was reported to have been lost to follow up (n = 0/151), At participant level, the overall loss to follow‐up was 26.8% (n = 863/3215); 30.6% (n = 189/618) in the brief advice group, 22.3% (n = 331/1484) in the tailored letters group, and 30.8% (n = 343/1113) in the combination group were lost to follow‐up at 12 months |
| Recruitment bias (cluster RCTs only) | Unclear risk | Participants were affiliated with the practice before randomization |
| Balanced baseline characteristics? (cluster RCTs only) | Low risk | QUOTE: "There were no significant differences in the characteristics of the participating practices and practitioners between study groups" |
| Adjustment for clustering in analysis? (cluster RCTs only) | Low risk | QUOTE: "For all analyses at the patient level, we took clustering within practices into account using sample survey methods in STATA 10.1" |