Lee 2019.
Study characteristics | ||
Methods | Design: Randomized controlled trial Recruitment: Recruited from motor company. Setting: Motor company, medical office in Korea Study start date: 5 January 2012; Study end date: 31 August 2012 |
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Participants | Total N: 150 N per arm: EC: 75; NRT: 75 Inclusion criteria:
Exclusion criteria:
Inclusion based on specific population characteristic: No 0% women; mean age 42.3; mean cpd: Not reported, 1.01 packs per day; mean FTND 4.05 Motivated to quit: Yes, or to reduce E‐cigarette use at baseline: Not specified |
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Interventions |
EC: Refillable Both arms received 50 mins education session on smoking cessation and use of smoking cessation aids in medical office (no further detail given). Asked to return to medical office every 4 weeks (to 24 weeks?) for “evaluation and counseling by an independent health practitioner” Arm 1: 50‐min education sessions on smoking cessation and the use of smoking‐cessation aids, instructed to visit the medical office each month for evaluation and counseling by a health practitioner who was unaffiliated with the study. Participants supplied with eGo‐CTM EC (nicotine 0.01 mg/mL) from Ovale in 12‐wk supply Arm 2: As (1) but instead of EC given 2 mg nicotine gum in 12‐wk supply |
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Outcomes | 12, 24 weeks (in person) Cessation: continuous abstinence from 9 ‐ 24 weeks, exhaled CO < 10 ppm, negative urine cotinine Adverse events and biomarkers: Yes but just note ‘adverse events’ Other outcomes measured: 7‐day PPA, cigarette reduction |
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Study funding | “none” | |
Author declarations | “none declared” | |
Notes | Study listed as ongoing study KCT0001277 in the 2016 review update | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “computer‐generated randomization sequence with a block size of 2” |
Allocation concealment (selection bias) | Low risk | Quote: “The enrolment and assignment of all subjects were performed by a clinical research coordinator not involved in the study” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not blinded but both interventions active with equal amounts of support, so performance bias judged unlikely |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants not blinded but results biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 61/75 NRT and 71/75 EC FU at 24 weeks |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |