Ellerbeck 2009.

Study characteristics
Methods	Design: Randomized controlled trial with 3 active trial arms Setting: Rural primary care practices, Kansas, USA
Participants	726 adults who smoked >10 cpd, randomized to intervention (n = 482) and control (n = 244), 41.5% M; av.age 47.2, 24 cpd
Interventions	Common component in all groups: offer of free pharmacotherapy Intervention 1: pharmacotherapy only At baseline and 6, 12,and 18 months, participants received a mailed offer of free pharmacotherapy that consisted of either 6‐weeks of nicotine patch (21 mg/d) or 7‐weeks of sustained‐release bupropion (150 mg twice daily) Intervention 2: moderate‐intensity disease management Participants received an offer of free pharmacotherapy (as above) with educational support and 2 telephone‐based counseling sessions every 6 months Intervention 3: high‐intensity disease management Participants received an offer of free pharmacotherapy (as above) with educational support and 6 telephone‐based counseling sessions every 6 months
Outcomes	7‐day PPA at 24m Validation: Salivary cotinine level < 15 ng/mL in a mailed saliva sample. Because of resistance by participants to providing salivary samples at month 12, validation by proxy report from a significant other at month 24 was used for quitters who did not return a salivary sample. The validated quit rate at 24m is a mixture of the 2 approaches
Funding Source	National Cancer Institute (grant R01‐101963). Study medication was provided by GlaxoSmithKline
Author's declarations of interest	Authors declared that they had no conflict of interest
Notes	Strategy: Adjunctive counseling + cost‐free medication Level: Patient Comparison type: Active vs. active (isolating adjunctive counseling)
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence Generation	Low risk	QUOTE: "randomization occurred at the participant level. A computer‐generated random‐number table was used to generate allocation cards in blocks of 24, with allocation equally distributed across treatment groups"
Allocation concealment	Low risk	QUOTE: "to conceal allocation, we placed these cards in sequentially numbered, opaque, sealed envelopes"
Blinding of outcome assessors All outcomes	Unclear risk	Smoking status was biochemically validated, but there was a low return rate and so proxy report was also used
Incomplete outcome data All outcomes	Low risk	The overall loss to follow‐up was 17.3% (n = 130/750); 13.2% (n = 33/250) in the PM group, 20.0% (n = 50/249) in the MDM group and 18.7% (n = 47/251) in the HDM group were lost to follow‐up at 24 months