| Methods |
Country: Netherlands
Recruitment setting: cardiac ward patients in 11 hospitals |
| Participants |
789 smokers who had smoked in previous week
Nurses had 2 hours training and delivered intervention alongside normal duties |
| Interventions |
1. Cardiologist advice on ward and 1st check‐up, GP notified, nurse provided stage‐of‐change‐based counselling and provided a self‐help cessation manual and a brochure on smoking and CHD. Nurse assessed smoking behaviour, addiction, motivation, addressed pros and cons, barriers and self‐efficacy, encouraged a quit date
2. Usual care (nurses on control wards intended to be blind to status)
Intensity: High (but not consistently delivered) |
| Outcomes |
Abstinence at 12 m (no smoking since hospital discharge)
Validation: none ('bogus pipeline') |
| Notes |
Process analysis indicated some implementation failure
Due to cluster‐randomization there were baseline differences between intervention and control participants. Raw numbers quit are misleading. Regression analyses suggest no significant effect on continuous abstinence at 12 m, so numbers quit in intervention group in MA adjusted to approximate the odds ratio and confidence interval from regression analysis |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
"The design was partially randomized: 4 of the 11 hospitals selected the experimental condition themselves... while the remaining 7 hospitals were randomly assigned." (Exclusion of the 4 hospitals who selected condition did not change results.) Baseline differences between intervention and control participants due to cluster randomization |
| Allocation concealment (selection bias) |
High risk |
See above |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Participants lost to follow‐up counted as smokers, with the exception of 25 deaths, 38 refusals, and 64 missing baseline data which were excluded from analysis denominator. Significantly more loss to follow‐up in intervention group |
