增加与临床试验参与者的接触可能会改善已确认的多发性硬化症复发的检测
Karla Gray-Roncal1, Mayaa J Appiah2, Kelsey Zorn2
1Johns Hopkins Medicine, Baltimore, MD, USA.
概括
定期检查显著改善了多发性硬化症 (MS) 临床试验中的复发检测. 在访问之间进行系统的症状查几乎可以将捕捉复发的几率增加三倍,从而提高试验准确性.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 多发性硬化症研究研究
背景情况:
- 准确的复发检测对于多发性硬化症 (MS) 临床试验至关重要.
- 在MS研究中,复发经常被发现不足,这可能会影响试验结果.
研究的目的:
- 评估定期参与者检查是否有助于在MS试验中捕捉复发.
- 调查系统性接触在改善复发确定的有效性.
主要方法:
- 一项涉及165名参加VIDAMS试验的研究.
- 评估了系统的访问间接触和复发检测之间的时间关联.
- 在入住检查期间,协调员使用了与症状相关的具体问题.
主要成果:
- 在计划接触后的两周内,检测确诊复发的几率几乎增加了三倍 (OR = 2.93,p = 0.01).
- 系统接触表明与复发检测有显著的积极关联.
结论:
- 在研究访问之间进行系统的症状查显示了改善MS试验中复发检测的前景.
- 这种方法可以提高临床试验数据的准确性和可靠性.
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