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. 2016 Sep 13;2016(9):CD010216. doi: 10.1002/14651858.CD010216.pub3
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
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
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
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