Brunner 2012.
Methods | Study design: Randomized controlled trial Setting: Single hospital, Denmark Recruitment: Inpatients with acute ischaemic stroke or TIA invited to participate |
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Participants | 94 inpatients | |
Interventions | Therapists: Single study nurse provided initial session for all participants, and 5 telephone and 1 outpatient session. Main counselling by"'authorized smoking cessation instructor" 1. Minimal intervention: 1 x 30‐min session, offer of nicotine patch during hospital stay 2. Intensive intervention; additional 5 outpatient sessions from counsellor, duration NS. Study nurse also offered 30‐min session at 6 wks and 5 telephone sessions at 2 days, 1 wk, 3 wks, 3 m, 4 m. Free samples of NRT |
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Outcomes | Abstinence 6m after discharge Validation: CO < 8 ppm |
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Notes | New for 2016 update Contributes to comparison of more versus less intensive Analysis 2.1 (no pharma subgroup) only. 8 minimal and 29 intensive intervention participants used NRT at some time |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomized using a computer‐generated list of odd and even numbers. These numbers, representing minimal and intensive smoking cessation intervention, respectively, were used to create consecutive numbered sealed envelopes." |
Allocation concealment (selection bias) | High risk | "After having obtained informed consent, the study nurse opened the randomization envelope and the patients were informed to which intervention they had been assigned." No mention that envelopes were opaque. Intensive intervention participants more likely to be younger, male, heavier smokers, suggesting possibility of selection bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up small and similar between conditions |