Lando 1991.
Methods | Study design: Randomized controlled trial Country: USA Recruitment: Community volunteers Group size: 4 ‐ 16, typically 6 ‐ 11 |
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Participants | 353 smokers; 52% women, av. age 42, av. cpd 30 Therapists: Trained facilitators, mainly graduates, including some who had quit through clinic programme | |
Interventions | Both interventions included 16 x 45 ‐ 60‐min sessions over a 9 wk period. Nicotine fading schedule prior to quit date at 3 wks 1. Enriched cohesiveness intervention: included written commitments and exercises designed to facilitate positive group interaction 2. Standard group treatment | |
Outcomes | 1‐yr sustained (relapse‐free) abstinence Validation: randomly selected subsample of those claiming abstinence tested for saliva TCN, but not clear whether reported data includes a correction for false reporting | |
Notes | No non‐group control. In comparison 2.3.2 evaluating group cohesion. Originally a factorial design comparing satiation and nicotine fading in addition to cohesiveness manipulation, but satiation arm abandoned. Only data for nicotine fading procedure arms reported in paper. P values reported in the paper were corrected for the design effects of clustering | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned by information group attended. 32 information meetings and 41 treatment groups |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Partial validation, all participants received active intervention |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 6.5% loss to follow‐up included in analyses |