随机对照试验对实验疗法的使用意识的影响
William F Clark1, Amit X Garg, Peter G Blake
1Division of Nephrology, London Health Sciences Centre, University of Western Ontario, London, Canada.
JAMA
|September 11, 2003
概括
随机对照试验 (RCT) 对于异位疗法导致使用量增加,但这种增长大部分发生在试验之外. 这种被称为"跳枪"的现象,突出了临床研究期间的非标签使用.
科学领域:
- 临床试验和医学研究
- 医疗保健服务研究 医疗服务研究
- 脏病学和神经病学 治疗疗法
背景情况:
- 在随机对照试验 (RCT) 之外使用实验性疗法尚未得到充分证实.
- 了解这种非标签用途对于评估治疗模式和试验影响至关重要.
研究的目的:
- 为了调查是否启动一个RCT的阿菲雷斯影响在试验之外使用这种疗法.
- 量化用于RCT内外的阿菲雷斯使用程度.
主要方法:
- 一个时间序列分析检查了多发性硬化症,血栓性血栓塞性紫外线和骨髓瘤质脏病的三个加拿大RCT期间的全国性阿菲雷斯使用情况.
- 分析了来自加拿大19个主要医疗中心的数据,包括审判前和审判期间的数据.
- 医生问卷评估了感知到的异位活动变化和归因原因.
主要成果:
- 这三项RCT都显示了阿菲雷斯使用的显著增加.
- 这种使用增加的大多数发生在正式试验协议之外 (61-72%的增加).
- 医生将这种激增归因于"跳枪"现象,表明治疗的过早采用.
结论:
- 启动用于阿菲雷斯疗法的RCT与其使用的大幅增加有关,主要是在试验之外.
- "跳枪"描述了在RCT期间增加非标签使用的观察趋势,即使没有确定的疗效.
- 这种行为在临床实践和试验设计中值得注意.
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