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. 2023 Jun 19;2023(6):CD013308. doi: 10.1002/14651858.CD013308.pub2

Krupski 2016.

Study characteristics
Methods Study design: parallel RCT
Country: USA
Recruitment: smokers who contacted the New York stop smoking quit‐line between March 2010 and October 2010
Participants 3118 smokers; aged ≥ 18 years, ≥ 20 cigarettes per day, 5 or 6 on Heaviness of Smoking Index, interested in using NRT to quit smoking
53% men, mode age range 45 to 54 years, average cigarettes per day not available but a large majority smoked > 30 cigarettes per day, 88% time to first cigarette < 5 minutes
Interventions 1) 2‐week supply of nicotine patches plus 2‐week supply of nicotine lozenges
2) 2‐week supply of nicotine patches
Advice to wear each patch for 24 hours, and to use lozenges consistently (every 1 to 2 hours while awake)
Outcomes Self‐reported 30‐day PPA at 7 months
Other abstinence measures: self‐reported 7‐day PPA at 7 months
Validation: none
Adverse events: not measured
Notes The study was funded by New York State Smokers’ Quitline (NYS Department of Health) and Roswell Park Cancer Institute Cancer Center Support Grant (NCI grant #P30 CA016056).
Conflicts of interest: "Dr. Cummings provides expert testimony in litigation against cigarette manufacturers, provides consulting advice and has received grants from Pfizer, and previously served as a co‐investigator on a multi‐center trial evaluating a nicotine vaccine from Nabi Biopharmaceuticals. Dr. Mahoney has provided expert testimony in litigation against cigarette manufacturers, has received research grants and speaker fees from Pfizer and served as an investigator on a multi‐center trial evaluating the potential efficacy of a nicotine vaccine for cessation sponsored by Nabi Biopharmaceuticals. Dr. Toll has received a grant from Pfizer for medicine only."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No detail on exactly how the randomisation sequence was generated or allocated.
Quote: "a randomised experimental design"
Allocation concealment (selection bias) Unclear risk As above
Blinding (performance bias and detection bias)
All outcomes High risk No blinding and no biochemical validation of abstinence
Incomplete outcome data (attrition bias)
All outcomes High risk Only 41.6% of participants were followed up, but loss to follow‐up was similar between groups (903/1557 in group 1 and 917/1561 in group 2)