Fiore 2004.

Methods	Setting: primary care patients, 16 clinics, USA Recruitment: clinic attenders willing to accept treatment
Participants	961 smokers of ≥ 10 cpd. (a further 908 were allowed to select treatment, not included in review. Demographic details based on 1869); 58% F, av age 40, av cpd 22 Therapists: trained cessation counsellors
Interventions	Pharmacotherapy: NRT (patch, 22 mg, 8 weeks including tapering) 1. NRT alone 2. As 1 plus Committed Quitters programme, single telephone session and tailored self‐help 3. As 2 plus face‐to‐face individual counselling, 4 x 15 to 25‐min sessions, pre‐quit, ˜TQD, next 2 weeks
Outcomes	Continuous abstinence at 1 year (no relapse lasting 7 days), also PP Validation: CO, cut‐off not specified. 2 discordant
Source of Funding/CoI	National Cancer Institute. SmithKline Beecham provided nicotine patches and access to the CQ program, but did not participate in any aspect of study design or data analysis.
Notes	3 versus 1 used in primary analysis. 3 & 2 versus 1 was more conservative since 2 had lower quit rates than 1. Use of PP outcome did not alter findings.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised, method not described
Allocation concealment (selection bias)	Unclear risk	No details given
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated
Incomplete outcome data (attrition bias) All outcomes	Low risk	People who did not pick up patches were excluded from analyses, similar distribution amongst groups (17% control, 16% in intervention arm 1, 14% intervention arm 2). No reported loss to follow‐up for remaining participants