Ellerbeck 2009.
| Methods | Settng: Primary care patients, 50 rural practices, Kansas, USA Recruitment: Smokers not selected for motivation, but 67% of those eligible enrolled, only 8.7% in precontemplation stage of change | |
| Participants | 750 smokers of > 10 cigs/day, 41% M, av. age 47, av. cigs/day 24, 61% contemplation, 30% preparation | |
| Interventions | All participants mailed an offer of free pharmacotherapy every 6 m, 4 times in total. Nicotine patch 21 mg for 6 weeks or bupropion SR (150 mg twice daily) for 7 weeks 1. Control. No other contact. 2. Moderate‐intensity disease management: up to 2 calls from counsellor in each cycle encouraging uptake of pharmacotherapy, newsletter mailings and periodic progress reports with counselling suggestions faxed to physician 3. High‐intensity disease management, up to 6 calls at approx 1, 3, 6, 9, 12 weeks from start of each cycle |
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| Outcomes | Abstinence at 24 m (PP). Study also reported analysis based on combination of effects at all follow‐up points. Sustained abstinence not a suitable outcome since no quit date and repeated intervention Validation: attempted saliva cotinine (< 15 ng/ml) by mail at 12 and 24 m. Proxy report used at 24 m for non‐returners. Rate of validation similar across groups |
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| Notes | For analysis on counselling intensity, classified on basis of average calls; moderate in 3 ‐ 6 sessions, high in 7+ subgroups | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computer generated random‐number table" in blocks of 24 |
| Allocation concealment (selection bias) | Low risk | Quote: "To conceal allocation, we placed these cards in sequentially numbered, opaque, sealed envelopes." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Differential rates of loss to follow‐up (1: 22.0%; 2: 31.3%; 3: 31.1%). Participants lost to follow‐up counted as smokers but sensitivity analysis shows no significant difference in analysis outcome if excluding those lost to follow‐up |