Background:Tobacco consumption is a leading cause of death and disease, killing >8 million people each year. Smoking cessation significantly reduces the risk of developing smoking-related diseases. Although combined treatment for addiction is promising, evidence of its effectiveness is still emerging. Currently, there is no published research comparing the effectiveness of blended smoking cessation treatments (BSCTs) with face-to-face (F2F) treatments, where web-based components replace 50% of the F2F components in blended treatment.Objective:The primary objective of this 2-arm noninferiority randomized controlled trial was to determine whether a BSCT is noninferior to an F2F treatment with identical ingredients in achieving abstinence rates.Methods:This study included 344 individuals who smoke (at least 1 cigarette per day) attending an outpatient smoking cessation clinic in the Netherlands. The participants received either a blended 50% F2F and 50% web-based BSCT or only F2F treatment with similar content and intensity. The primary outcome measure was cotinine-validated abstinence rates from all smoking products at 3 and 15 months after treatment initiation. Additional measures included carbon monoxide–validated point prevalence abstinence; self-reported point prevalence abstinence; and self-reported continuous abstinence rates at 3, 6, 9, and 15 months after treatment initiation.Results:None of the 13 outcomes showed statistically confirmed noninferiority of the BSCT, whereas 4 outcomes showed significantly (P<.001) inferior abstinence rates of the BSCT: cotinine-validated point prevalence abstinence rate at 3 months (difference 12.7, 95% CI 6.2-19.4), self-reported point prevalence abstinence rate at 6 months (difference 19.3, 95% CI 11.5-27.0) and at 15 months (difference 11.7, 95% CI 5.8-17.9), and self-reported continuous abstinence rate at 6 months (difference 13.8, 95% CI 6.8-20.8). The remaining 9 outcomes, including the cotinine-validated point prevalence abstinence rate at 15 months, were inconclusive.Conclusions:In this high-intensity outpatient smoking cessation trial, the blended mode was predominantly less effective than the traditional F2F mode. The results contradict the widely assumed potential benefits of blended treatment and suggest that further research is needed to identify the critical factors in the design of blended interventions.Trial Registration:Netherlands Trial Register 27150; https://onderzoekmetmensen.nl/nl/trial/27150
Risk assessment instruments are widely used to predict risk of adverse outcomes, such as violence or victimization, and to allocate resources for managing these risks among individuals involved in criminal justice and forensic mental health services. For risk assessment instruments to reach their full potential, they must be implemented with fidelity. A lack of information on administration fidelity hinders transparency about the implementation quality, as well as the interpretation of negative or inconclusive findings from predictive validity studies. The present study focuses on adherence, a dimension of fidelity. Adherence denotes the extent to which the risk assessment is completed according to the instrument’s guidelines. We developed an adherence measure, tailored to the ShortTerm Assessment of Risk and Treatability: Adolescent Version (START:AV), an evidence-based risk assessment instrument for adolescents. With the START:AV Adherence Rating Scale, we explored the degree to which 11 key features of the instrument were adhered to in 306 START:AVs forms, completed by 17 different evaluators in a Dutch residential youth care facility over a two-year period. Good to excellent interrater reliability was found for all adherence items. We identified differences in adherence scores on the various START:AV features, as well as significant improvement in adherence for those who attended a START:AV refresher workshop. Outcomes of risk assessment instruments potentially impact decision-making, for example, whether a youth’s secure placement should be extended. Therefore, we recommend fidelity monitoring to ensure the risk assessment practice was delivered as intended.
