Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction.
Contemp Clin Trials
; : 107662, 2024 Aug 12.
Article
em En
| MEDLINE
| ID: mdl-39142511
ABSTRACT
BACKGROUND:
Mitigating attrition is a key component to reduce selection bias in longitudinal randomized controlled trials (RCTs). Few studies of electronic nicotine delivery systems (ENDS) allow for the examination of long-term retention. This analysis explores the relationship between attrition, baseline measures, and condition assigned for a RCT involving ENDS differing in nicotine delivery over a 24-week intervention period.METHODS:
Participants (Nâ¯=â¯520) who smoked ≥10 cigarettes per day [CPD] for ≥1â¯year and reported interest in reducing but not quitting were randomized to 1 of 4 conditions an ENDS containing 0, 8, or 36â¯mg/ml liquid nicotine (administered double-blind) or a cigarette-shaped plastic tube. Cox proportional hazards regression models were fit to examine attrition over time and predictors of attrition including baseline characteristics and condition. A stepwise approach was used to determine the final model; alpha was set at 0.05.RESULTS:
Attrition did not differ significantly by condition (223/520), and most (69%) were lost-to-follow-up. Only age, education level, and household income were significantly predictive of attrition. For every additional year of age, attrition risk fell by 3%. Holding a bachelor's degree or higher was associated with reduced attrition risk. Those with the lowest income (<$10â¯K) were more likely to be withdrawn compared to those earning $10â¯K-39â¯K, and those with the highest income ($100â¯K+) were more likely to be withdrawn compared with the latter bracket and those earning $70-99â¯K.CONCLUSION:
ENDS nicotine content did not drive differential attrition in this trial, and targeted retention efforts is needed for specific subgroups. Trial Registration # NCT02342795.
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MEDLINE
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Ano de publicação:
2024
Tipo de documento:
Article