Ioakeimidis 2018.
Study characteristics | ||
Methods | Design: Randomized controlled trial Recruitment: Not specified Setting: Hospital, Greece. Study start date/Study end date: Not specified |
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Participants | Total N: 54 N per arm: Arm 1: 27; Arm 2: 27 Inclusion criteria:
Exclusion criteria:
Inclusion based on specific population characteristic: People who have experienced acute coronary syndrome 65% women; mean age 52; mean cpd 21; mean FTND 5.6 Motivated to quit: Yes E‐cigarette use at baseline: No prior EC use |
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Interventions |
EC: information on whether cig‐a‐like or refillable not provided Both arms given "low intensity counselling" Intervention 1: 12‐week use of EC 12 mg/ml nicotine Intervention 2: 12‐week varenicline |
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Outcomes | Weeks: 4, 12, 24 Cessation: 7‐day PP at 24 weeks, self‐report Adverse events and biomarkers: Unclear how these were reported. Abstract says no SAEs, poster implies this may have just been CV or neuropsychiatric SAEs. Abstract says nothing about AEs but nausea and sleeping disorders given in table in poster. Implies (S)AEs collected during treatment period only Other outcomes measured: Not specified |
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Study funding | Not reported | |
Author declarations | Not reported | |
Notes | New for 2020 update. Abstract and poster only; limited data available | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specified |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not specified but equal amounts of contact and support between arms so performance bias judged unlikely |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐report only but equal amounts of contact between arms, no reason to suspect differential misreport |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not specified |
Selective reporting (reporting bias) | Unclear risk | Abstract/poster only so not able to judge |
Other bias | High risk | Abstract and poster only. Two different figures presented for quit rate in EC arm (no difference in those presented in varenicline arm) between abstract and poster. Poster percentage aligns with figure, so using that (16.5%) as opposed to abstract figure (32.5%). Contacted authors but no reply. Calculated n quit based on percentages but unclear what denominators were; EC calculates back to whole number for EC but not for varenicline |