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. 2019 Feb 13;2019(2):CD003999. doi: 10.1002/14651858.CD003999.pub5
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