NEXit 青少年短信戒烟干预试验的 6 个月结果：采用贝叶斯分析的随机对照试验
Six-Month Outcomes from the NEXit Junior Trial of a Text Messaging Smoking Cessation Intervention for High School Students: Randomized Controlled Trial With Bayesian Analysis.
机构信息
Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
Department of Medical Specialist, Motala Hospital, Motala, Sweden.
出版信息
JMIR Mhealth Uhealth. 2021 Oct 21;9(10):e29913. doi: 10.2196/29913.
BACKGROUND
The prevalence of daily or occasional smoking among high school students in Sweden was approximately 20% in 2019, which is problematic since lifestyle behaviors are established in adolescence and track into adulthood. The Nicotine Exit (NEXit) Junior trial was conducted in response to a lack of evidence for the effects of text message smoking cessation interventions among high school students in Sweden.
OBJECTIVE
The aim of this study was to estimate the 3- and 6-month effects of a text messaging intervention among high school students in Sweden on smoking cessation outcomes.
METHODS
A 2-arm, single-blind randomized controlled trial was employed to estimate the effects of the intervention on smoking cessation in comparison to treatment as usual. Participants were recruited from high schools in Sweden using advertising and promotion by school staff from January 10, 2018, to January 10, 2019. Weekly or daily smokers who were willing to make a quit attempt were eligible for inclusion. Prolonged abstinence and point prevalence of smoking cessation were measured at 3 and 6 months after randomization.
RESULTS
Complete case analysis was possible on 57.9% (310/535) of the participants at 6 months, with no observed statistically significant effect on 5-month prolonged abstinence (odds ratio [OR] 1.27, 95% CI 0.73-2.20; P=.39) or 4-week smoking cessation (OR 1.42; 95% CI 0.83-2.46; P=.20). Sensitivity analyses using imputation yielded similar findings. Unplanned Bayesian analyses showed that the effects of the intervention were in the anticipated direction. The findings were limited by the risk of bias induced by high attrition (42.1%). The trial recruited high school students in a pragmatic setting and included both weekly and daily smokers; thus, generalization to the target population is more direct compared with findings obtained under more strict study procedures.
CONCLUSIONS
Higher than expected attrition rates to follow-up 6 months after randomization led to null hypothesis tests being underpowered; however, unplanned Bayesian analyses found that the effects of the intervention were in the anticipated direction. Future trials of smoking cessation interventions targeting high school students should aim to prepare strategies for increasing retention to mid- and long-term follow-up.
TRIAL REGISTRATION
IRCTN Registry ISRCTN15396225; https://www.isrctn.com/ISRCTN15396225.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-3028-2.
背景
2019 年，瑞典高中生每日或偶尔吸烟的比例约为 20%，这是一个问题，因为生活方式行为是在青少年时期形成的，并会持续到成年。Nicotine Exit（NEXit）青少年试验是针对瑞典高中生短信戒烟干预效果缺乏证据而进行的。
目的
本研究旨在估计瑞典高中生短信干预对戒烟结果的 3 个月和 6 个月影响。
方法
采用 2 臂、单盲随机对照试验，将干预组与常规治疗进行比较，估计干预对戒烟的影响。参与者通过广告和学校工作人员的宣传从瑞典的高中招募，招募时间为 2018 年 1 月 10 日至 2019 年 1 月 10 日。愿意尝试戒烟的周吸烟或日吸烟的参与者符合入选条件。在随机分组后 3 个月和 6 个月测量延长戒烟和吸烟点流行率。
结果
6 个月时可对 57.9%（310/535）的参与者进行完整案例分析，5 个月延长戒烟的效果无统计学意义（比值比 [OR] 1.27，95%CI 0.73-2.20；P=.39）或 4 周戒烟（OR 1.42；95%CI 0.83-2.46；P=.20）。使用插补进行敏感性分析得出了类似的结果。未计划的贝叶斯分析显示，干预的效果符合预期方向。由于高脱落率（42.1%）导致的偏倚风险限制了研究结果。该试验在务实的环境中招募了高中生，包括周吸烟和日吸烟的参与者；因此，与更严格的研究程序获得的结果相比，结果更直接适用于目标人群。
结论
随机分组后 6 个月随访的高脱落率导致无效假设检验的效能不足；然而，未计划的贝叶斯分析发现干预的效果符合预期方向。针对高中生的戒烟干预措施的未来试验应旨在制定增加中、长期随访保留率的策略。
试验注册
IRCTN 注册表 ISRCTN15396225；https://www.isrctn.com/ISRCTN15396225。
国际注册报告标识符（IRRID）：RR2-10.1186/s13063-018-3028-2。
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