Methods | Design: Prospective observational cohort study Recruitment: Patients presenting with cancer at large US cancer centre; smokers referred to tobacco cessation programme (TCP). This study included all patients who completed TCP intake assessment, 2012 ‐ 2013 Setting: Cancer centre, USA Inclusion criteria: Smokers (smoked cigarettes or used other tobacco products within past 30 days) accepting cessation programme Exclusion criteria: none stated |
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Participants | Total N: 1074. 781 eligible for 6 ‐ 12m follow‐up 56.5% women, mean age 56, mean cpd 13, mean FTND 3.7. At baseline, 26.5% (285/1074) had used EC within last 30 days, 92% dual users |
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Interventions | All participants offered "multicomponent, evidence‐based behavioral and pharmacologic treatment for tobacco dependence”; plans differed by individual but offered up to 5 sessions of phone or in‐person counselling | |
Outcomes | Follow‐up ranged from 6 to 12m after enrolling in TCP (mean 10m). Collected: Self‐reported 7‐day PP abstinence Gone at least 1 day without smoking CPD |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Observational |
Allocation concealment (selection bias) | High risk | Observational |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Although there is no blinding, the study design means that there is unlikely to be significantly impact on performance |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐report only but differential misreport across EC conditions judged to be unlikely |
Incomplete outcome data (attrition bias) All outcomes | High risk | Large number of participants (285) lost to follow‐up (of eligible, 59.5% followed up). A further 82 deceased “significantly higher percentage of E‐cigarette users dropped out of tobacco treatment and were lost to follow‐up than non–E‐cigarette users”. Complete‐case analysis not significant, ITT analysis significant. |
Selective reporting (reporting bias) | Unclear risk | Unable to determine prespecified outcomes |