2 Simon 2009.
Study characteristics | ||
Methods | Setting: San Francisco Veterans Affairs Medical Center, USA
Recruitment: hospitalized volunteers Study start date: January 2004; Study end date: August 2006 |
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Participants | 85 inpatient smokers, 3.5% female, av age 56 yrs, av BMI 27.5, av cpd 16 | |
Interventions |
All ppts received Individual cognitive behavioural 30 ‐ 60 mins during hospital stay + 5 phone calls at wk 1, wk 3, wk 5, wk 8, wk 12; recycling encouraged |
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Outcomes | Mean (SD) weight change (kg) in continuous abstainers at 6m (data from email communication) validation: saliva cotinine < 15 ng/ml | |
Study funding | "California Tobacco‐Related Disease Research Program (12RT‐0148)" | |
Author declarations | "None declared" | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | used a computer algorithm to generate a random list of treatment assignments |
Allocation concealment (selection bias) | Low risk | All study personnel engaged in providing interventions to participants were blinded to treatment assignment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Double‐blind + placebo controlled. Quote: “All study personnel engaged in providing interventions to participants were blinded to treatment assignment.“ “A significant percentage of participants were able to guess whether they were taking either active bupropion or placebo“ |
Blinding of outcome assessment (detection bias) Smoking | Low risk | Quote: "Because many of the participants live great distances from the SFVAMC, we used salivary cotinine levels ( ≥ 15 ng/ml) as an indicator of current tobacco use, rather than measuring carbon monoxide in person (Jarvis, Tunstall‐Pedoe, Feyerabend, Vesey, & Saloojee, 1987 ). We permitted the mailing of saliva samples in special envelopes when necessary. For self‐reported quitters who had salivary cotinine levels of 15 ng/ml or higher, we ascertained by telephone interview whether they were using NRT at the time the sample was provided. We considered three participants (two in the bupropion arm and one in the placebo arm) to be nicotine dependent and, thus, smokers" |
Blinding of outcome assessment (detection bias) Weight | High risk | Quote: "Body mass index and change in weight over time were determined using self‐reported or medical record data“. Comment: Participants were blinded to treatment condition, but a significant percentage correctly guessed allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 24‐week completion bupropion + counselling group: 38/42 (90.47%) (2 withdrew, 1 died, 1 lost to follow‐up); 24‐week completion placebo + counselling group: 36/43 (83.72%) (5 withdrew, 1 died, 1 lost to follow‐up) |