确定静止性低血压问卷 (OHQ) 的临床重要差异最小值
Horacio Kaufmann1, Jose-Alberto Palma1, Ross Vickery2
1Department of Neurology, New York University School of Medicine, New York, NY, USA.
概括
确定了正静性低血压问卷 (OHQ) 的最小临床重要差异 (MCID). 这些新的值改善了对神经性正静性低血压 (nOH) 临床试验的OHQ分数的解释.
科学领域:
- 临床神经学 临床神经学
- 患者报告的结果.
- 临床试验方法论 临床试验方法论
背景情况:
- 神经性正静性低血压 (nOH) 显著影响日常功能和生活质量.
- 静态低血压问卷 (OHQ) 是nOH研究中患者报告的关键结果指标.
- 确定OHQ的最小临床重要差异 (MCID) 对于解释试验结果至关重要.
研究的目的:
- 为了确定总OHQ分数的MCID,其分级 (OHSA和OHDAS) 和特定症状项目 (OHSA1).
- 为了提高OH的临床试验中的OHQ分数的解释性.
主要方法:
- 从两个3期随机选的安慰剂对照试验 (SEQUOIA和REDWOOD) 的数据分析.
- 使用基于和基于分布的方法来计算MCID.
- 为总的OHQ,OHSA复合,OHDAS复合和OHSA1.1计算的MCID.
主要成果:
- 对于整体OHQ改善 (0.9-1.2分减少) 和恶化 (0.7-1.1分增加) 的确立的MCID.
- 为OHSA复合改善 (0.9-1.3分减少) 和恶化 (0.7-1.1分增加) 确定了MCID.
- 对OHSA1的改善 (2.0-3.0分减少) 和恶化 (1.0分增加) 定义了MCID;没有可靠地建立OHDAS MCID.
结论:
- 为OHQ和OHSA建立的MCID值为临床试验提供了有价值的基准.
- 这些发现支持继续使用OHQ来评估nOH的治疗疗效.
- 增强的分数解释性有助于评估nOH患者的临床益处.
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