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. 2021 Sep 6;2021(9):CD011556. doi: 10.1002/14651858.CD011556.pub2

Ockene 1994.

Study characteristics
Methods Design: 3‐group randomized controlled trial
Setting: Primary care, USA
Recruitment: Opportunistic recruitment from practice
Participants 1499 adults who smoked aged 18 ‐ 75 years, 57% F, av.age 35.3, 23 cpd
Interventions Intervention 1: participants received simple, individualized advice to stop smoking from their physician
Intervention 2: participants received counseling with a patient‐centered approach, consisting of questions addressing motivation and a written plan for change. Participants also received a self‐help booklet and a list of local smoking cessation programs and scheduling of a follow‐up visit or telephone call
Intervention 3: participants received the same counseling as in intervention, plus a prescription of free 2 mg nicotine gum if agreed to set a quit date
Outcomes Maintained 7‐day PPA at 12m
Validation: None
Funding Source National Cancer Institute Grant
Author's declarations of interest Not reported
Notes Strategy: Cost‐free medications
Level: Patient
Comparison type: Single component vs. standard care
Risk of bias
Bias Authors' judgement Support for judgement
Sequence Generation Unclear risk No details reported
Allocation concealment Unclear risk No details reported
Blinding of outcome assessors
All outcomes High risk Self‐reported smoking cessation plus varying contact between groups
Incomplete outcome data
All outcomes Unclear risk The overall loss to follow‐up was 15.9% (n = 238/1499) at 12 months. No further details on the number lost to follow‐up by group were reported