Kumral 2016.
Study characteristics | ||
Methods | Design: Prospective randomized clinical trial Recruitment: All patients admitted to a smoking cessation clinic at the Department of Otorhinolaryngology‐Head and Neck Surgery, Okmeydanı Training and Research hospital Setting: Smoking cessation clinic, Turkey Study start date: March 2013; Study end date: November 2013 |
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Participants | Total N: 98 but analysis excludes 16 from intervention and 10 from control who did not stop smoking; thus 72 analyzed N per arm: EC: 58 (42 ana lysed); Non‐EC 40 (30 ana lysed) Inclusion criteria:
Exclusion criteria:
Inclusion based on specific population characteristic: No 44% women; mean age 36; mean cpd and mean FTND not specified Motivated to quit: “All patients were willing to quit smoking” E‐cigarette use at baseline: Not specified |
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Interventions |
EC: Unclear EC arm: “used EC to quit smoking” – allowed to select brand and flavor, used “medium density” liquid (11 ‐ 12 mg/ml) (no further detail given) Non‐EC arm: Received cognitive behavioral therapy (no further detail given) |
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Outcomes | 3 Months Sino‐nasal outcome test (SNOT‐22) via self‐administered questionnaire, to evaluate changes in subjective symptoms. Saccharin transit test to evaluate nasal mucociliary clearance (MCC) function which authors state is “an important defence mechanism” |
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Study funding | Not specified | |
Author declarations | Not specified | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Patients participating in the study were randomly divided into two groups; EC smokers (group 1) and non‐EC smokers (group 2).” No further detail provided |
Allocation concealment (selection bias) | Unclear risk | No information given |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded. The trial is described as single‐blinded and outcome assessors were blinded. No placebo used |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcome data, participants not blinded and unequal amounts of support between arms |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropout rate not clear. Only ana lysed people who quit |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported |