Camarelles 2002.
Methods | Study design: Randomized controlled trial Country: Spain Recruitment: Primary care Group size: 10 ‐ 14 |
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Participants | 106 smokers (any amount); 54% women, av. age 47, av. cpd 25 Therapists: 1 doctor, 3 nurses, trained and experienced | |
Interventions | 72 participants eligible for nicotine patch, 53 used 1. Group therapy, 7 x 2 hrs over 3 wks, TQD after wk 3 2. Individual counselling, not matched for intensity, 2 sessions over 2 wks, with S‐H materials | |
Outcomes | Sustained abstinence at 6 m Validation: none | |
Notes | Comparison 1.2.2 between group and shorter individual therapy Slightly higher and longer use of NRT in group condition | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized, method not described |
Allocation concealment (selection bias) | Unclear risk | Sealed opaque envelopes, but chosen by participant. Since all received a cessation intervention, potential for selection bias probably low |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No biochemical validation but all participants received a cessation intervention |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on losses to follow‐up but all participants included in denominators |