Mak 2020.
Study characteristics | ||
Methods |
Study design: RCT Location: Hong Kong Setting: primary care Recruitment: from 6 primary healthcare centres Study dates: 2012‐15 |
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Participants | N = 144 Specialist population?: no Definition of smoker used: ≥ 1 cpd in the past 30 days Participant characteristics: 29% female; average age: 46 years; 22% primary education or less; 18% unemployed; 16% household income ≤ HKD 9999; 17% average cpd > 20; 38% high nicotine dependence |
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Interventions |
Comparator: brief advice + self‐help materials Mode of delivery: face‐to‐face, written materials Intensity: brief 5 minute talk Pharmacotherapy: none Type of therapist/provider: not reported BCTs: 1.2 Problem solving, 4.1 Instruction on how to perform the behaviour, 5.1 Information about health consequences Intervention: ACT + self‐help materials Mode of delivery: face‐to‐face, telephone, written materials Intensity: 1 face‐to‐face ACT session and 2 telephone follow‐up sessions (each 15‐20 min) Pharmacotherapy: none Type of therapist/provider: experienced health counsellor trained in the principles of ACT applied in smoking cessation BCTs: 1.2 Problem solving, 4.1 instruction on how to perform the behaviour, 5.3 Information about social and environmental consequences, 12.6 Body changes |
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Outcomes |
Definition of abstinence: 7‐day point prevalence Longest follow‐up: 12 months Biochemical verification: CO < 6 ppm was measured but validated quit rates are not reported Other relevant outcomes reported: none |
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Notes |
Relevant comparisons: ACT + self‐help vs brief advice + self‐help Funding source: Health and Medical Research Fund of the Food and Health Bureau of the Hong Kong SAR Government (10111861) Author conflicts of interest: “The authors declare that they have no competing interests.” |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “The process of randomization was based on computer‐generated, block randomization with random block sizes, which were placed in sealed opaque envelopes." |
Allocation concealment (selection bias) | Low risk | Quote: “The process of randomization was based on computer‐generated, block randomization with random block sizes, which were placed in sealed opaque envelopes." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Although abstinence was biochemically verified, only unverified quit rates are reported and we were unable to obtain verified rates from the study authors. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Attrition was high: at 12‐month follow‐up 50.0% (35/70) were lost to follow‐up in the intervention group and 58.1% (43/74) in the control group |
Selective reporting (reporting bias) | Unclear risk | Abstinence was defined as prespecified, although 12 month follow‐up was not prespecified. 6 month rates are not reported so unclear whether the reporting of 12‐month rates is an example of selective reporting |