| Methods |
Setting: 7 chest clinics, Denmark
Recruitment: outpatient attender motivated to enrol in trial of cessation medication |
| Participants |
370 smokers of >1 cpd with COPD (178 in arms of interest); 52% F, av. age 61, av. cpd 20
Providers: 20 nurses with cessation experience, trained to support medication use and provide standardised counselling |
| Interventions |
Factorial trial. Nicotine sublingual tablet versus placebo and high versus low support
1. High support: 7 x 20‐30min clinic visits (0, 2, 4, 8, 12 wks, 6m, 12m) & 5 x 10min phone calls (1, 6, 10 wks, 4½m, 9m), total contact time 4½ hrs.
2. Low support: 4 clinic visits (0, 2 wks, 6m, 12m) & 6 phone calls (1, 4, 6, 9, 12 wks, 9m), total time 2½ hrs |
| Outcomes |
Sustained abstinence at 12m (validated at all visits from wk 2, PP also reported)
Validation: CO < 10 ppm |
| Notes |
NRT and high support versus placebo and low support used for meta‐analysis.Therapists were not full time specialist counsellors. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Block randomization list at each centre |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation process not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
82 (22%) of total in trial lost to follow‐up, 14 deaths, all included as smokers (support condition not specified for dropouts or deaths) |
