| Methods |
Country: Canada
Recruitment setting: Inpatients with cardiovascular disease (MI, angina, CHF) or PVD, unselected by motivation |
| Participants |
168 past‐month smokers
Av. age 56
Intervention delivered by a research nurse |
| Interventions |
1. Counselling by research nurse (1 x 10 ‐ 60 mins, av. 40 mins, based on Transtheoretical Model, included component to enhance social support from a significant family member), 23% used pharmacotherapy
2. As 1, plus telephone follow‐up, 6 calls over 2 m post‐discharge, 29% used pharmacotherapy
3. Control: cessation advice, 11% used pharmacotherapy. |
| Outcomes |
Abstinence at 6 m (sustained at 2 m and 6 m)
Validation: Urine cotinine or CO |
| Notes |
2 interventions combined versus control in high‐intensity subgroup. 1 versus 2 used in higher versus lower comparison |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Cluster randomization was used... by first randomly assigning individuals to predetermined clusters of three to six subjects. The group assignment was then randomly assigned to each of these clusters." |
| Allocation concealment (selection bias) |
Low risk |
"Individuals not familiar with the study were in charge of the randomization procedure, which included inserting the information into envelopes that were sealed and would be opened by the investigator only at the time of treatment." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
4 deaths and 3 not meeting follow‐up criteria excluded from MA; all other dropouts and those lost to follow‐up counted as smokers; similar numbers in all arms |
