Robinson Miqun L, Schroeder Jennifer R, Moolchan Eric T
Clinical Pharmacology and Treatment Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, U.S. Department of Health and Human Services, MD 21224, USA.
Nicotine Tob Res. 2006 Jun;8(3):447-54. doi: 10.1080/14622200600670413.
The enrollment process determines the study sample and external validity of clinical trial results; however, few reports describe the process and outcome of screening efforts for smoking cessation studies among adolescents. We describe and evaluate a screening protocol to enroll adolescent smokers for a randomized clinical trial of nicotine replacement therapy. Adolescent smokers obtained the recruitment call-in number (1-800-NO-SMOKE) via media and other advertisements. Trained recruitment staff collected information using an internally developed, targeted telephone screening interview, which was used to determine pre-eligibility for the clinical trial. Correlates of qualification and of study enrollment were determined. Among 1,347 adolescents screened, 329 (24.4%) were eligible to participate in the trial. Light smoking (39.1%) and lack of parental support (14.8%) were the biggest contributors to ineligibility. Eligible adolescents were more likely to be female (66.9% vs. 58.2%, p = .0052) and more likely to be European American (63.5% vs. 52.2%, p = .0003). The higher rates of ineligibility for African Americans and boys were partly explained by lower scores on the Fagerström Test for Nicotine Dependence. Of those eligible to participate in the trial, 159 (48.3%) enrolled. Results underscore the need for screening instruments that are measurement-invariant across ethnicities and gender, and for enrollment strategies that maximize inclusion of eligible participants.
入组过程决定了临床试验结果的研究样本和外部有效性；然而，很少有报告描述青少年戒烟研究的筛查过程和结果。我们描述并评估了一项用于招募青少年吸烟者参加尼古丁替代疗法随机临床试验的筛查方案。青少年吸烟者通过媒体和其他广告获取招募热线号码（1-800-NO-SMOKE）。经过培训的招募人员使用内部开发的针对性电话筛查访谈收集信息，该访谈用于确定临床试验的初步资格。确定了资格和研究入组的相关因素。在1347名接受筛查的青少年中，329名（24.4%）有资格参加试验。轻度吸烟（39.1%）和缺乏父母支持（14.8%）是不符合资格的最大因素。符合条件的青少年更有可能是女性（66.9%对58.2%，p = 0.0052），更有可能是欧美裔（63.5%对52.2%，p = 0.0003）。非裔美国人和男孩不符合资格的比例较高，部分原因是尼古丁依赖的Fagerström测试得分较低。在有资格参加试验的人中，159名（48.3%）入组。结果强调需要有在不同种族和性别间测量不变的筛查工具，以及需要有能最大限度纳入符合条件参与者的入组策略。
