Methods |
Country: Spain
Recruitment: primary care |
Participants |
106 adult smokers (excludes 81 not beginning treatment)
65% female, average age 36, average cpd 25 |
Interventions |
1. Gum (2 mg) for 3 to 4 months
2. Placebo gum for 3 to 4 months
Level of support: high (group therapy, 7 sessions over 3 months) |
Outcomes |
Sustained abstinence at 6 months
Validation: CO ≤ 7 ppm |
Notes |
Sources of support not reported |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Method not stated |
Allocation concealment (selection bias) |
Unclear risk |
Quote: "La asignación a los grupos de estudio se realizaba aleatoriamente al acudir a la primera entrevista" |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Described as double‐blind ("doble ciego") |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Dropouts reported at 1, 3 and 6 months. Analyses appear to be ITT‐based, counting dropouts as failures |