Sawicki 1993.
Methods | Study design: Randomized controlled trial Country: Germany Recruitment: From a university diabetic outpatients clinic |
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Participants | Diabetic smokers prepared to participate in a stop‐smoking programme; 40% women, av. age 37, av. cpd 21 | |
Interventions | 1. Extensive behaviour therapy including self‐control. 10 x 90‐min weekly sessions. Led by a psychotherapist 2. Physician advice, 15‐min unstructured session. NRT offered in the case of severe addiction | |
Outcomes | Abstinence at 6 m Validation: serum cotinine < 20 ng/ml | |
Notes | Comparison 1.3.1 | |
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 | No details given |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 25/44 participated in group programme and 31/45 received physician advice Non‐participants followed up and included in ITT analysis |