Chan 2011.
Methods | Study design: RCT Location: China Setting: unclear Recruitment: local media advertisements and contact with previous cohorts of smokers who had had cessation counselling but failed to quit |
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Participants | N = 1154 Specialist population?: no Participant characteristics: 208/1154 (18%) female; average age: 42 y; average cig/day: 20; nicotine dependence: FTND 5.2 Preference for quitting abruptly versus gradually: not reported |
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Interventions | Comparator 1: Simple cessation advice: self‐help quitting pamphlet, plus 10 mins of simple advice on the health hazards of smoking and the importance of smoking cessation Modality of support: face‐to‐face Overall contact time: 10 mins Number of sessions: 1 Pharmacotherapy: none Quit date set?: no Intervention 1: Smoking reduction and cessation counselling: individual counselling in smoking reduction, plus a self‐help quitting pamphlet. "Specific SR counselling emphasized achieving the ultimate goal of complete cessation by focusing on the importance of SR before quitting, how reduction is useful and effective when quitting is difficult, and on how to reduce". Modality of support: face‐to‐face Overall contact time: 30 mins Number of sessions: 3 Pharmacotherapy: 8‐week supply of either nicotine gum or patches starting at baseline Quit date set?: no Intervention 2: Smoking reduction and cessation counselling + NRT adherence counselling: individual counselling in smoking reduction and adherence to NRT, plus a self‐help quitting pamphlet. "Specific SR counselling emphasized achieving the ultimate goal of complete cessation by focusing on the importance of SR before quitting, how reduction is useful and effective when quitting is difficult, and on how to reduce". Modality of support: face‐to‐face Overall contact time: 30 mins Number of sessions: 3 Pharmacotherapy: 8‐week supply of either nicotine gum or patches starting at baseline Quit date set?: no |
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Outcomes | Definition of abstinence: 7‐day point prevalence Longest follow‐up: 6 m Biochemical validation: urinary cotinine (< 115 ng/ml) and exhaled CO (< 9 ppm) |
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Funding source | Health and Health Services Research Fund, Hong Kong SAR (Project no. 01030611). Nicotine patches/gum provided free of charge by Pfizer (later named McNeil AB) | |
Author conflicts of interest | "None of the authors have any connections to the tobacco, alcohol, pharmaceutical, gaming industries, or anyone substantially funded by one of these organizations" | |
Notes | Relevant comparisons: 1) Reduction versus abrupt; 2) Reduction method versus reduction method (complementary NRT adherence counselling) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The random numbers for group assignment were generated by the research assistant (not the counsellors) of the project using a personal computer before subject recruitment" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was performed by opening of a serially labelled, opaque and sealed envelope with a card inside indicating the randomly allocated group by a trained smoking cessation counsellor" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence was biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 52/479 (11%) in reduction + adherence group, 44/449 (10%) in reduction group, and 10/226 (4%) in simple cessation group were lost to follow‐up. Attrition rates were low and similar across groups |