| Methods |
Country: Denmark
Recruitment setting: 7 outpatient chest clinics |
| Participants |
370 smokers of > 1 cpd with COPD
52% women, av. age 61, av. cpd 20 |
| Interventions |
Factorial trial. Nicotine sublingual tablet and placebo arms collapsed in MA
1. High support: 7 x 20 ‐ 30‐min clinic visits (0, 2, 4, 8, 12 wks, 6 m, 12 m) and 5 x 10‐min phone calls (1, 6, 10 wks , 4½ m. 9 m), total contact time 4½ hrs
2. Low support: 4 clinic visits (0, 2 wks, 6 m, 12 m) and 6 phone calls (1, 4, 6, 9, 12 wks, 9 m), total time 2½ hrs |
| Outcomes |
Sustained abstinence at 12 m (validated at all visits from wk 2, PP also reported)
Validation: CO < 10 ppm |
| Notes |
Not in main comparison; compares different intensities of nurse counselling |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Patients were allocated to one of the four treatment groups using a block randomization list at each center." |
| Allocation concealment (selection bias) |
Unclear risk |
Not specified |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
82/370 participants lost to follow‐up and counted as smokers. "One potential bias may have been the large early dropout of failures from the study. Consequently, these patients were not exposed to the possible effect of more intensive support." |
