Killen 2008.
Methods | Study design: Randomized controlled trial Setting: Community cessation clinic, USA Recruitment: Community volunteers |
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Participants | 301 smokers (≥ 10 cpd or 3.5 packs/wk) (excludes 3 participants who received wrong treatment); 40% women, av. age ˜46, av. cpd ˜20 | |
Interventions | Therapists: 'one of three staff interventionists trained and supervised by the study psychologist and psychiatrist who had previous training in behavioral therapy' All participants received 6 x 30‐min individual CBT sessions at baseline, TQD, 1, 2, 4, 6 wks, and combination pharmacotherapy (Bupropion (300 mg, 9 wks) and NRT (21 mg patch, 8 wks incl tapering)) 1. Extended therapy: 4 x 30‐min sessions at 8, 12, 16, 20 wks, and weekly check in calls to automated system; report of relapse or craving prompted proactive calls 2. Standard therapy: 5‐min general support calls at 8, 12, 16, 20 wks |
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Outcomes | Abstinence at 52 wks (7‐day abstinence at both 20 and 52 wks) (Continuous abstinence also reported but not used in MA as could underestimate any effect on recycling) Validation: CO < 10 ppm (11 self‐reported quitters no longer living in study area accepted as quitters without validation) |
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Notes | New for 2016 update. Tested extended duration therapy, contributes only to comparison of counselling intensity (Analysis 2.1) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized using a permuted block method (block size = 4), stratified on gender |
Allocation concealment (selection bias) | Low risk | Participants assigned to next available ID number in corresponding gender. Researchers and participants were blinded to extended treatment assignment to the end of the open‐label phase |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 89% followed up in standard‐care group, 90% followed up intervention group |