| Methods |
Country: USA
Recruitment/setting: Inpatients with CVD or PVD admitted to 10 hospitals |
| Participants |
277 female current smokers or recent quitters (smoked in month before admission), willing to make serious quit attempt at discharge
Av. age 61, av. cpd 18 ‐ 19
Intervention delivered by trained research nurses |
| Interventions |
1. As usual care + nurse‐managed cessation and relapse prevention: 30 ‐ 45 mins individual counselling predischarge with multimedia materials. Up to 5 phone calls (5 ‐ 10 mins) at 2, 7, 21, 28, 90 days. Relapsers offered additional session
2. Usual care; brief physician counselling, Self‐help pamphlet, list of resources
Patch or gum offered to selected women after discharge who had relapsed and wanted to try to quit (pharmacotherapy used by 20% of intervention and 23% of control group)
Intensity: High |
| Outcomes |
Abstinence at 12 m (7‐day PP). Also followed at 24 m, 30 m but validation not attempted
Validation: Saliva cotinine < 14 ng/ml or family/friend verification |
| Notes |
New for 2008/1 update
11 deaths at 12 m, excluded from cessation denominators. 73% of participants reached at all 4 follow‐ups |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Randomization was by random permuted blocks, stratified by hospital, with an equal chance of assignment to the usual‐care group or the intervention group." |
| Allocation concealment (selection bias) |
Low risk |
Centralized randomization |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
20 participants (13 intervention; 7 control) lost to follow‐up included in MA as smokers. 11 deaths excluded from MA |
