Methods | Setting: hospitals, USA Recruitment: hospitalised smokers approached by Respiratory Therapists Design: 2 x 2 (nicotine patches x counselling) factorial design |
|
Participants | 1270 smokers, 320 no patches, 317 patches, 317 no counselling, 316 counselling 56.7% male, average age 50, average cigs/day 15 |
|
Interventions | 2 x 2 factorial design Intervention 1: control plus NRT patches matched to cigs/day: 6 to 10 cigs/day = 6 weeks of 14 mg patches and 2 weeks of 7 mg patches. 11/+ cigs/day = 4 weeks of 21 mg patches and 2 weeks of 14 mg patches and 2 weeks of 7 mg patches Intervention 2: control plus telephone counselling: initial call: 30 to 40 minutes, with up to 8 follow‐up calls of 10‐15 minutes Intervention 3: control plus telephone counselling and patches Control: standard care: brief beside intervention < 10 minutes |
|
Outcomes | 30‐day point prevalence at 6 months Validation: Cotinine < 10 ng/mL at 6 months |
|
Notes | No attempt to constrain participants from using other quit‐smoking services Funding: "This research was supported by a grant from the National Cancer Institute (CA159533)" Declaration of interests: "No financial disclosures were reported by the authors of this paper." |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer randomisation stratified by recruitment site and cigarettes per day |
Allocation concealment (selection bias) | Unclear risk | Concealment not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding not described |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Results biochemically verified |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low rates of attrition |