Romand 2005.

Methods	Study design: Randomized controlled trial Country: France, 6 towns Recruitment: Community volunteers, motivated to quit
Participants	228 smokers 54% women, av. age 42, av. cpd 20 Therapists: 2 professionals per group, e.g. trained psychologist and qualified health adviser
Interventions	1. Five Day Plan (FDP); 5 sessions on consecutive nights, & supplementary sessions 1 ‐ 2 wks later 2. Control; 1 hr of general information on tobacco‐related health problems
Outcomes	Abstinence at 12 m, lapse‐free (PPA also reported) Validation: CO < 10 ppm
Notes	In comparison 1.3.2 Using the less stringent definition of abstinence would reduce the effect, 16% vs 11% quit. A small number of control group participants attended other FDP courses or used pharmacotherapy
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomized, stratified by town, "balanced every four individuals"
Allocation concealment (selection bias)	Unclear risk	No details given. The discrepancy in group sizes suggests the possibility of selection bias, but may be due to the stratification & chance
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemical validation of abstinence
Incomplete outcome data (attrition bias) All outcomes	Low risk	17% & 15% lost at 12 m, included as smokers in ITT analysis