Methods |
Setting: Hospital/community, Norway
Recruitment: Inpatients with diagnosis of myocardial infarction, not selected for motivation |
Participants |
133 daily smokers amongst 288 participants. Demographics not given for smoking subgroup |
Interventions |
1. Usual care; outpatient visit at 6 ‐ 8 weeks and primary care follow‐up
2. Structured but individualised proactive TC addressing lifestyle issues including smoking, diet and exercise. Nurse‐initiated calls at 1, 2, 3, 4, 6, 8, 12, 24 weeks post‐discharge. Smoking not explicitly addressed at each call. Reactive phone support line available 6 hours/week |
Outcomes |
Abstinence at 6, 12 and 18 m (assumed PP, not defined). Primary trial outcome was health‐related quality of life
Validation: none |
Notes |
18‐m follow‐up data added in 2013. Smoking was addressed as part of a multicomponent intervention. TC as adjunct to brief/minimal intervention |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomised by computer‐generated list |
Allocation concealment (selection bias) |
Unclear risk |
Sequence in sealed opaque envelopes but not stated to be numbered. Fewer control group participants raises possibility of selection bias, so not classified as low risk |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Self‐reported outcomes from participants not blinded to treatment condition. Level of personal contact differed between arms |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
At 18 m, losses amongst baseline smokers 29% in 1, 30% in 2 . Losses reincluded as smokers in this MA |