Schmitz 1999.
Methods | Study design: Randomized controlled trial Setting: Hospital, USA Recruitment: women with or at risk of CAD |
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Participants | 2 separate samples recruited: 53 inpatients with CAD who stopped smoking during hospitalization and wanted to stay quit 107 women volunteering for cessation treatment who had > 1 CAD risk factor | |
Interventions | Therapists: 2 smoking counsellors + 2 clinical psychology interns 1. Coping skills, relapse prevention, 6 x 1‐hr including stress management, homework 2. Health Belief model, 6 x 1‐hr, smoking‐related health information about disease state or CAD profile Focus on benefits of stopping |
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Outcomes | Abstinence at 6 m (PP) Validation: CO < 9 ppm, urine cotinine < 10 ng/ml Not all quitters tested, confirmation rates not reported | |
Notes | Post‐randomization dropouts who did not complete baseline and begin treatment were not included in any data Quit rates were lower in the CAD sample than in the at‐risk group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomly assigned", stratified on smoking rate and myocardial infarction status |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Some validation of abstinence, arms had similar intensities of treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Pretreatment dropouts were excluded, all others included in ITT analysis |