Orleans 1991.

Methods	Setting: HMO, USA Recruitment: largely through publicity in HMO magazine
Participants	2021 smokers; 63% female, average age 44, average cpd 26
Interventions	∙ Free & Clear ‐ 28‐page guide incorporating nicotine fading and standard behavioural abstinence and relapse prevention techniques. Also, a Quit Kit and ALA publication, A Lifetime of Freedom from Smoking ∙ Same materials as first bullet above plus 2 copies of a social support guide to be given to "allies" ∙ Same materials as second bullet above plus TC plus quitline ∙ Control ‐ Referral guide describing available self‐help guides and local resources, plus NCI publication, Clearing the Air
Outcomes	Abstinence at 16 months for over 6 months by blinded telephone interview Validation: saliva cotinine < 10 ng/mL, or thiocyanate < 2400 μmol/L for gum users
Notes	1 plus 2 vs 4, effect of self‐help alone (3 assessed in TC review) By 16 months, 59% of participants in the control group reported that they had used an additional treatment method
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised; method not stated; stratified by living alone/not; advice to quit in last 12 months/not and nicotine content of cigarette brand
Allocation concealment (selection bias)	Unclear risk	No details given
Blinding (performance bias and detection bias) All outcomes	Low risk	All arms included in this review received written material at similar levels of intensity. Biochemical validation in sample at 16 months "to improve the veracity of smoking self‐report, all follow‐up questionnaires and interviews began with a reminder that the subjects might be asked for a saliva specimen for nicotine assessment, creating a sort of 'bogus pipeline'"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up 6% at 16 months; did not differ across treatment groups Analyses based on respondents, including losses, would marginally increase estimated effect