Ikonomidis 2018.
Study characteristics | ||
Methods | Design: (acute phase) Randomized cross‐over assignment (outcomes measured within hours of the intervention and hence do not meet the criteria of 1 week or more); chronic phase: non‐randomized, single‐group assignment Recruitment: Hospital smoking cessation unit Setting: Hospital smoking‐cessation unit, Greece Study start date: 31 January 2017; Study end date: Estimated completion date: December 2021 |
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Participants | Total N: 90 Inclusion criteria:
Exclusion criteria:
Inclusion based on specific population characteristic: No 54% women; mean age 50.2; mean cpd 23.4; mean FTND: Not reported Motivated to quit: Yes – recruited from smoking cessation unit E‐cigarette use at baseline: Not reported |
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Interventions |
EC: not clear E cigarette details: In the chronic phase, all 70 participants were instructed to replace their conventional cigarettes (con‐cig) with an e‐cig containing nicotine (12 mg/dL (e‐cig fluid with nicotine concentration of 12 mg/mL (propylene glycol 74.3%, glycerin 20%, flavoring 4.5%, nicotine 1.2%))) for 1 month |
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Outcomes | 1 month; Self‐report and objective measures Cessation: Self‐report cessation at 1 month. CO measured at 1 month. Cessation data not used as < 6 months Adverse events and biomarkers:
Other outcomes measured:
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Study funding | This study was supported by a grant from the Hellenic Cardiology Society and Hellenic Society of Lipidiology and Atherosclerosis. | |
Author declarations | None | |
Notes | New for 2020 update. Acute phase of trial not relevant for the review as very short‐term outcomes | |
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 | High risk | Not blinded and differential levels of support given |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Objective measures used for all outcomes reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 70 participants and 20 controls recruited – no dropout |
Selective reporting (reporting bias) | Unclear risk | NCT record states that chronic endothelial integrity, platelet aggregation and high‐shear stress‐dependent platelet function would be assessed but is not reported in this research letter – however study estimated completion date is December 2021, so perhaps data not ready for publication or limited capacity in the research letter – not the primary publication |
Other bias | Unclear risk | Few details – written as commentary. Trial registration suggests this is an ongoing study |