Liu Jingmin, Peterson Arthur V, Kealey Kathleen A, Mann Sue L, Bricker Jonathan B, Marek Patrick M
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, 1100 Fairview, Ave N., M2-C826, P.O. Box 19024, Seattle, WA 98109-1024, USA.
Prev Med. 2007 Aug-Sep;45(2-3):215-25. doi: 10.1016/j.ypmed.2007.05.018. Epub 2007 Jun 4.
Well-documented challenges have hampered both intervention development and research in teen smoking cessation. Addressing these challenges, the Hutchinson Study of High School Smoking (HS Study), the largest group-randomized trial in adolescent smoking cessation to date, incorporates several design innovations to investigate the effect of a counselor-initiated, individually tailored telephone counseling smoking cessation intervention for older adolescents. This paper presents and discusses these innovative design features, and baseline findings on the resulting study population.
The trial used a population-based survey to proactively identify and recruit all high school juniors who had smoked in the past month - potentially expanding intervention reach to all smokers, even those who smoked less than daily and those not motivated to quit. For ethical and intervention reasons, some nonsmokers were enrolled in the intervention, also. Other important design features included the random allocation of schools into experimental conditions (intervention vs. no-intervention control) and a multi-wave design.
The design innovations address problems and challenges identified in adolescent smoking cessation literature. The heterogeneous baseline characteristics of the study population, well-balanced between the two arms, have three significant implications: They (1) demonstrate the effectiveness of the trial's design features, (2) highlight several intervention-related issues, and (3) provide assurance that the trial's evaluation of intervention effectiveness will be unbiased.
有充分记录的挑战阻碍了青少年戒烟干预措施的开发和研究。为应对这些挑战,哈钦森高中吸烟研究(HS研究)是迄今为止青少年戒烟领域规模最大的群组随机试验,采用了多项设计创新,以调查由咨询师发起的、针对年龄较大青少年的个性化电话咨询戒烟干预措施的效果。本文介绍并讨论了这些创新设计特点,以及关于最终研究人群的基线研究结果。
该试验采用基于人群的调查方法,主动识别并招募过去一个月内吸烟的所有高三学生——这有可能将干预范围扩大到所有吸烟者,甚至包括那些并非每天吸烟以及没有戒烟意愿的人。出于伦理和干预方面的原因,一些不吸烟者也被纳入了干预组。其他重要的设计特点包括将学校随机分配到实验条件(干预组与无干预对照组)以及多波次设计。
这些设计创新解决了青少年戒烟文献中所指出的问题和挑战。研究人群的异质性基线特征在两组之间达到了良好平衡,具有三个重要意义:它们(1)证明了试验设计特点的有效性,(2)突出了几个与干预相关的问题,(3)确保了试验对干预效果的评估将是无偏的。