Ledgerwood 2014.
Methods | Country: USA Setting: University clinic, Michigan Design: 3‐arm randomized controlled trial |
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Participants | 81 participants (17 Standard Care, 28 Traditional CM, 36 Early‐Treatment Enhanced CM). Participants were adult nicotine‐dependent smokers with Fagerström score ≥ 4 and English literacy. Exclusions: uncontrolled psychiatric disorders, substance dependence (except for nicotine and caffeine), in recover for pathological gambling, already receiving smoking cessation treatment. 50 (62%) female, average age 45 years, 27 (33%) European American, 53 (65%) African American, 1 (1%) Other ethnicity, average education 14 years, average cpd 16.6. Around average 1 year more education in CM participants than Standard Care participants. |
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Interventions | Standard Care: in weeks 2 to 5, CO and cotinine monitoring + 5 minutes counselling twice daily, 5 days a week. Participants received US$1 per sample submitted + bonus of US$20 for submitting all 10 samples in a week. Traditional CM: as Standard Care, + entry into prize draws. Prize urn contained 250 slips of paper, 50% with a reward: 44.8% Small (worth around US$1, e.g. snacks, toiletries), 4.8% Large (worth around US$20, e.g. gift certificates, electronics), 0.4% Jumbo (worth US$100, e.g. DVD player, gift certificate). On Day 1, participant drew for a prize if CO down by at least 3 ppm, and on subsequent days if CO down by at least 6 ppm. Number of draws available increased by 1 per day for every day abstinent, to a maximum of 5 at the end of the week. 5 bonus draws were awarded for Monday cotinine level ≤ 100 ng/mL in weeks 3 to 5. In total 180 regular draws and 15 bonus draws were possible. Enhanced CM: As for Traditional CM, but in the first week of prize draws a prize was guaranteed if test was negative. Cotinine‐negative tests also received a guaranteed prize. The guaranteed prize urn contained 91.2% Small, 8% Large, 0.8% Jumbo prizes. Subsequent weeks used a regular prize urn with 30% Small, 4% Large, 0.2% Jumbo prizes. |
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Outcomes | PPA, cotinine (≤ 100 ng/mL) and CO (≤ 6 ppm) verified, at 2 months and 6 months. Prize money won, attendance at CM schedules. |
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Notes | Traditional CM versus Standard Care is the comparison used in this review. Also in ISC. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Statistician‐prepared sequentially numbered randomization envelopes concealed group assignment until assigned. |
Allocation concealment (selection bias) | Low risk | As above. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical verification used. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 6m dropout by group: Standard Care 2/17, Traditional CM7/28, Enhanced CM 10/36. Differences not significant and ITT analyses performed. |