Tulloch 2016.
Study characteristics | ||
Methods | Study design: parallel RCT Country: Canada Recruitment: by advertising (radio, local newspaper and posters), from people presenting to the Quit Smoking programme at the institution, and from referrals by local physicians |
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Participants | 737 smokers (490 in relevant trial arms); aged ≥ 18 years, ≥ 10 cigarettes per day, willing to make a quit attempt in the next 2 to 4 weeks 53.6% men, average age 48.6, average cigarettes per day 23.2, mean FTND 6.1, average years smoked 31, average number of previous quit attempts 4.6 |
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Interventions | 1) Nicotine patch for 10 weeks beginning on quit day (maximum 21 mg/day or 14 mg/day depending on baseline cigarettes per day, decreasing from week 7) 2) Self‐titrated nicotine patch (maximum 35 mg/day) and ad libitum nicotine gum or inhaler for up to 22 weeks |
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Outcomes | Validated continuous smoking abstinence from week 5 to 52 Other measures: validated 7‐day PPA at 52 weeks Validation: expired CO ≤ 9 ppm Adverse events: measured at each appointment (0, 1, 3, 5, 8, 10, 22, 52 weeks). Note treatment lasted either 10 or 22 weeks, depending on arm |
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Notes | Funding from the Heart and Stroke Foundation of Ontario (Grant‐in‐Aid #6614). Conflicts of interest: AP and RR have received research grants from Pfizer. AP and BR have been paid for developing and delivering educational presentations for Pfizer. AP is on the advisory board for Pfizer and Johnson & Johnson. Not included in any meta‐analyses as any comparison would be confounded by other factors |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "After eligibility was confirmed by one of the principal investigators (HT, AP), participants were randomized to receive NRT, NRT+, or VR using a computer‐generated block randomization schedule by a statistical consultant not involved in the trial" |
Allocation concealment (selection bias) | Low risk | Quote: "After eligibility was confirmed by one of the principal investigators (HT, AP), participants were randomized to receive NRT, NRT+, or VR using a computer‐generated block randomization schedule by a statistical consultant not involved in the trial" |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants not blinded to treatment condition Quote: “The research coordinator collecting follow‐up data at weeks 22 and 52 was blind to treatment condition.” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | > 50% followed up at strictest quit time point (152/245 and 171/245). Similar dropout between arms. 15 and 12 participants in the arms of interest were excluded due to death or moving away |