跨研究地点的症状报告异质性:随机对照的多中心抗疟疾试验的二次分析
Kamala Thriemer1, Robert James Commons2,3, Megha Rajasekhar4
1Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia. Kamala.ley-thriemer@menzies.edu.au.
BMC medical research methodology
|September 4, 2023
概括
研究性药物试验显示,在研究地点,患者报告症状的差异很大,特别是轻度症状. 治疗组之间的症状的相对差异比绝对数字更可靠.
科学领域:
- 临床药理学 临床药理学
- 药物的安全性和耐受性
- 全球卫生健康 全球卫生健康
背景情况:
- 在临床试验中主观的症状报告给标准化带来了挑战.
- 了解症状报告中的特定地点变化对于准确的安全性和耐受性评估至关重要.
- 试验性药物管理需要强大的方法来量化患者报告的结果.
研究的目的:
- 在疟疾药物试验中,在多个研究地点调查症状报告的变化.
- 为未来的临床试验设计提供信息,并改进安全性和耐受性数据的解释.
- 在多中心环境中识别影响症状报告差异的因素.
主要方法:
- 来自IMPROV试验的数据分析,这是一项针对预防疟疾的普莱马奎因随机,安慰剂对照研究.
- 在随访时使用了13点的症状问卷.
- 采用多变量逻辑回归来调整混因素,并估计特定部位的症状比例.
主要成果:
- 在四个国家的八个研究地点观察到症状报告 (例如,厌食症) 的显著变化.
- 对共变量进行调整略有减少,但没有消除特定地点的差异.
- 报告中的差异在轻度/中度症状中比严重症状更明显,在不同地点之间比在不同地点内的治疗臂之间更大.
结论:
- 标准化培训并没有消除在试验地点报告症状的实质性差异.
- 严重的症状显示报告变异性比主观的轻度/中度症状少.
- 治疗臂之间症状的相对差异比绝对数量更有信息性,特别是在不同的研究地点.
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