Pérez‐Milena 2012.
Methods | Country: Spain Setting: 5 high schools Study design: RCT |
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Participants | Participants: 91 (I = 43, C = 48), 49% female Age: mean 15.4 Criteria for inclusion: ≤ 20 years, attending participating high schools, smoking ≥ 1 cpw over last 6 months. Excluded for mental/psychiatric illness/disability, pregnancy, using any smoking cessation pharmacology, student or parents or tutors not wishing student to participate Follow‐up method: in person Inducements to enter study: none Baseline characteristic equivalence: Pre‐test smoking status assessment: self‐report, I = 84%, C = 81% were daily smokers, cpd 8.3 during the week but 15.9 at weekends, FTND 3.1, 62% were low dependence (0‐3) Post‐test smoking status assessment: biochemically validated self‐report |
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Interventions | Intervention: 4 x 15‐min weekly sessions with GPs, focus on initial reduction, signing a declaration to quit at 3rd visit and 4th visit for reinforcement Theoretical basis for intervention: MI Control: a single 15‐min session with brief advice and a leaflet. All participants sent a text message on quit date, the day before and a week after, and monthly emails for a year |
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Outcomes | Measurement: 12‐month continuous abstinence Relevant follow‐up periods: 12 months Verification: expired CO ≤ 6 ppm (Smoke Check) Loss to follow‐up: 3 of 91 |
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Notes | New for 2017 update | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Simple randomization stratified by school, using Epidat 3.1 |
Allocation concealment (selection bias) | Low risk | "Blinded allocation" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel would have been aware of group assignment, as it was a behavioural intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 losses, counted as smokers for meta‐analysis |