Scheibein 2020.
Study characteristics | ||
Methods | Design: Non‐randomized single‐arm Recruitment: From supported temporary accommodation (STA) service STA project workers and support staff identified potential study participants who smoked and wished to quit Setting: Dublin Simon Community, Ireland Study start date: Recruitment February 2019 (overall trial start date March 2018). Study end date: June 2019 |
|
Participants | Total N: 23 but only report baseline for the 9 that completed the study. % female 8.7% (2/23) at baseline, (22.2% 2/9) completed and reported; mean age 43.89 (SD 7.36); mean cpd 25.22 (SD 7.77); mean FTND 7.89 (SD 1.2); mean CO 21.89 (SD 14.4 corresp) E‐cigarettes use at baseline: no Motivated to quit: yes Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
EC: Refillable Electronic‐cigarette: Endura T22e Electronic Nicotine Delivery System and 2 10 ml bottles of fluid strengths (0, 6, 11, 18 and 20 mg/ml) and flavors ('Purple Berry', 'Ice Menthol', 'Regular Blend' and 'American Tobacco') |
|
Outcomes | Baseline (‘week 1’), week 4, week 8, week 12: CO, adverse events Also number of cigarettes smoked; Fagerström Test Scores |
|
Study funding | This study was completed as part of a Tobacco Harm Reduction Scholarship funded by Knowledge Action Change | |
Author declarations | FS was a recipient of a Tobacco Harm Reduction Scholarship provided by Knowledge Action Change. He is currently the recipient of an Enhanced Scholarship from the same organization. AM and KM acted as mentors for both the Tobacco Harm Reduction Scholarship and Enhanced Scholarship. AM is an associate of New Nicotine Alliance. KM is a recipient of a grant from the Foundation for a Smoke Free World. JW declares no interests. WR declares no interests |
|
Notes | New for 2021 update | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Only 1 arm |
Allocation concealment (selection bias) | High risk | Not randomized |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not randomized |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported adverse events |
Incomplete outcome data (attrition bias) All outcomes | High risk | 9/23 completed. Reason was many people moved away so not linked to unacceptability of the study. Incomplete paperwork to enable to be followed |
Selective reporting (reporting bias) | Unclear risk | Protocol published afterwards |