Ikonomidis 2020a.
Study characteristics | ||
Methods | RCT Recruitment: Smoking cessation clinic of second cardiology department of National and Kapodistrian University of Athens, Attikon General Hospital Setting: Hospital smoking‐cessation unit, Greece Study start date: NS |
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Participants | N = 40; Arm 1 E‐cigarette n = 20; Arm 2 conventional tobacco cigarette n = 20 80% female; mean age 44.8 (SD 11.3); mean cpd: 25.8 (C‐cig 25.5 SD 9.3. E‐cig: 26.2 SD 9.1) Inclusion criteria:
Exclusion criteria:
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Interventions |
EC: Refillable E‐cig: second‐generation e‐cig device and popular in Greek Market e‐liquid (NOBACCO eGo Epsilon BDC 1100, eGo battery, 1100 mAh, operating at 3.9 V ‐ propylene glycol 74.3%, glycerin 20%, flavoring 4.5%, nicotine 1.2%/12 mg/ml) |
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Outcomes | Baseline, 4 months: Exhaled CO concentration; blood pressure Also, cpd; Ppatelet function by Platelet Function Analyzer PFA‐100 and Light Transmission Aggregometry; Pulse wave velocity; Plasma malondialdehyde levels as oxidative stress index |
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Study funding | "There was no funding for this study" | |
Author declarations | "The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers as reproduced from the online randomization software www.graphpad.com/quickcalcs/index |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Only CO outcomes used here, which are objectively measured |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All followed up (confirmed via contact with authors) |
Selective reporting (reporting bias) | Unclear risk | No protocol or clinical trial record available to confirm whether all prespecified criteria were reported |