Brunette 2017.
| Methods | Setting: New Hampshire, USA; community mental health centres Recruitment: Through flyers, clinician referral, and direct mail | |
| Participants | 661 medicaid beneficiaries with mental illness and low income (< USD 1317 a month) willing to initiate cessation treatment within 30 days, 36% M, av. age 45, av. cigs/day 17.3 | |
| Interventions | 1. Usual care, a prescriber visit for smoking cessation (NRT or cessation medications, i.e. bupropion/varenicline) 2. As in 1, plus referral to New Hampshire Tobacco Helpline which provides an average of 3 manualised TC sessions 3. As in 1, plus TC (av. 9 sessions) CBT initiated by a CBT therapist |
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| Outcomes | Abstinence at 12 m (7‐day PP) Validation: breath CO ≤ 4 ppm and urine cotinine < 100 ng/ml (or solely breath CO if using NRT) |
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| Notes | New for 2018 update. Funding: "This research received financial support from the Centers for Medicare and Medicaid Services (Medicaid Incentives for the Prevention of Chronic Diseases grant 1B1CMS330880) and from the New Hampshire Department of Health and Human Services (NHDHHS)." Declarations of interest: "Dr. Brunette reports receipt of research funding from Alkermes. The other authors report no financial relationships with commercial interests." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Computer‐generated tables for each strata within each site were used for random assignment." |
| Allocation concealment (selection bias) | High risk | Quote: "We used equipoise randomization [...] that allowed participants to opt out of one of the cessation treatment conditions or allowed randomization to any of the three options. [...] Randomization strata were defined by conditions to which the participant was willing to be randomly assigned. Within the stratum, a participant was then randomly assigned with equal probability to the selected treatment condition options." Not a true randomisation method; participants can choose what intervention they do not want to be allocated to and this can lead to selection bias. This led to different numbers between arms, and significant baseline age differences |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Biochemical validation for only half of the participants in the trial (those receiving an incentive), and there are significant differences between those receiving and not receiving an incentive. Level of personal contact differed between arms |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Proportion of participants lost to follow‐up was lower than 50% overall |