Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001 Zürich, Switzerland; Swiss Research Institute for Public Health and Addiction associated with the University of Zurich, Konradstrasse 32, 8031 Zurich, Switzerland.
Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001 Zürich, Switzerland; Swiss Research Institute for Public Health and Addiction associated with the University of Zurich, Konradstrasse 32, 8031 Zurich, Switzerland; La Source, School of Nursing Sciences, HES-SO University of Applied Sciences and Arts of Western Switzerland, Av. Vinet 30, 1004 Lausanne, Switzerland.
J Affect Disord. 2018 Dec 1;241:417-424. doi: 10.1016/j.jad.2018.08.027. Epub 2018 Aug 12.
Traditional statistical analyses of clinical trials encompass the central tendency of outcomes and, hence, are restricted to a treatment's average effectiveness. Our aim was to get a more complete picture of the effectiveness of standard treatment options for adolescent depression, by analyzing treatment effects across low, middle, and high levels of response.
Secondary data analysis was performed of the Treatment for Adolescents with Depression Study (TADS, ClinicalTrials.gov, NCT00006286), a randomized controlled trial comparing fluoxetine (FLX), cognitive-behavioral therapy (CBT), and their combination (COMB) against placebo treating adolescents with major depression (n = 439). The proportional change from baseline to week 12 in the Children's Depression Rating Scale-Revised was used as an index of response. Response levels were analyzed via quantile regression models, thereby estimating treatment effects across the entire response level distribution, adjusted for baseline depression, study site, and patients' treatment expectancies.
Whereas CBT was no more effective than placebo across response levels, COMB was more effective than FLX in that its quantile treatment effects were both larger in magnitude and spread out across a broader range of response levels, including the low end of the response level distribution. Cohen's d of the difference was 1.39 (95% confidence interval 1.33-1.45).
Ad-hoc analysis using data from a trial that was not originally designed to accommodate such analysis.
The combination of cognitive-behavioral therapy and fluoxetine was more effective than either treatment used alone, not just in average effectiveness, but in the breadth of patients in whom it was effective.
传统的临床试验统计分析涵盖了结果的集中趋势，因此仅限于治疗的平均效果。我们的目的是通过分析低、中、高反应水平的治疗效果，更全面地了解青少年抑郁症标准治疗选择的有效性。
对青少年抑郁症治疗研究（TADS，ClinicalTrials.gov，NCT00006286）进行二次数据分析，这是一项比较氟西汀（FLX）、认知行为疗法（CBT）及其组合（COMB）与安慰剂治疗青少年重度抑郁症的随机对照试验（n=439）。儿童抑郁评定量表修订版（CDRS-R）从基线到第 12 周的比例变化被用作反应的指标。通过分位数回归模型分析反应水平，从而估计整个反应水平分布的治疗效果，调整基线抑郁、研究地点和患者的治疗预期。
尽管 CBT 在反应水平上并不优于安慰剂，但 COMB 比 FLX 更有效，因为它的分位数治疗效果在幅度上更大，并且在更广泛的反应水平范围内分布，包括反应水平分布的低端。差异的 Cohen's d 为 1.39（95%置信区间为 1.33-1.45）。
使用原本不是为了适应这种分析而设计的试验数据进行的特设分析。
认知行为疗法与氟西汀联合使用比单独使用任何一种治疗方法都更有效，不仅在平均效果上，而且在治疗效果显著的患者范围上。
