Tricker 2012a.
Study characteristics | ||
Methods | Design: RCT Study dates: not reported Recruitment: no information Location: Seoul, South Korea Setting: confinement in‐clinic setting |
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Participants | Number randomised: 72 Characteristics: 25.0% women; mean age 23.8 years; all participants smoked ≥ 10 cigarettes per day; mean FTND score 3.9 for men and 3.3 for women Specialist population: aged 20–50 years Inclusion criteria
Exclusion criteria
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Interventions | Randomised (2:2:1 ratio) to use an electronic HTP, continue smoking cigarettes, or become abstinent Heated tobacco arm Device heating method: electronic Device name: EHCSS‐K3, precursor to THS marketed under brand name IQOS Device manufacturer: PMI Other instructions and details: participants were given tobacco sticks Behavioural support: none mentioned Instructions for smoking cessation/switching: switch entirely to heated tobacco use for study period Cigarette smoking arm Other instructions and details: participants were given Lark1 low yield cigarettes Behavioural support: none mentioned Instructions for smoking cessation/switching: continue smoking Lark1 cigarettes for study period Abstinence arm Behavioural support: none mentioned Instructions for smoking cessation/switching: do not smoke cigarettes during study period |
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Outcomes | Follow‐up time points: 1 week (8 days) Abstinence outcomes: N/A Safety outcomes: biomarkers of exposure to toxins and carcinogens; biomarkers of harm; adverse events; serious adverse events Prevalence/sales outcomes: N/A |
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Notes |
Funding source Tobacco industry funded: quote: "The work reported in all eight parts of this supplement was funded by PMI R&D". Author conflicts of interest Quote: "All authors are or were Philip Morris International (PMI) R&D employees or worked for PMI R&D under contractual agreements". |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details on random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | No information. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All outcomes were biological. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on attrition. |
Selective reporting (reporting bias) | Unclear risk | No trial registration or analysis plan. |