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. 2019 Feb 13;2019(2):CD003999. doi: 10.1002/14651858.CD003999.pub5
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)
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