Methods | Setting: cessation clinic, Germany Recruitment: community volunteers | |
Participants | 256 smokers, no demographic details | |
Interventions | 5 conditions, partly factorial. All received nicotine patch, dose individualised for conditions 1 to 4, plus 9 weekly sessions, including reduction, self‐monitoring, contract management, risk avoidance. TQD after 6 weeks 1. Additional training in relapse‐coping strategies (during cessation phase) 2. Additional 3 booster sessions, 6 months after end of main therapy 3. Relapse‐coping and boosters 4. Control 5. Control (fixed‐dose nicotine patch) |
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Outcomes | Abstinence 12 months post‐EOT (point prevalence). Rates estimated from graphs Validation: random urine nicotine, 'almost 100% conformity', no correction | |
Notes | 3 versus 4 in contact matched comparison, 1 plus 2 versus 4 in extended contact comparison Inclusion of control group 5 (fixed dose) would marginally increase intervention benefit | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly assigned to experimental groups after previously being matched for age, sex and cigarette consumption" |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information provided |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding reported but biochemical confirmation taken at random, with 'almost 100% conformity' |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 15/256 (5.9%) dropouts excluded, assignment not given, so not included in analysis |