概念化有意义的跨组差异随着时间的推移而发生的变化:展示可能的观点
Andrew Trigg1, Nicolai D Ayasse2, Cheryl D Coon2
1Medical Affairs Statistics, Bayer plc, Reading, UK. andrew.trigg@bayer.com.
概括
在临床试验中确定有意义的组间差异 (MBGD) 是复杂的. 本研究探讨了各种观点,得出结论,主观的利益相关者判断与建立MBGD值的数据一起是必不可少的.
科学领域:
- 临床结果评估的临床结果评估.
- 健康 结果 研究 研究 结果
- 生物统计学 生物统计学
背景情况:
- 焦点已经从群体层面转移到个人层面,对健康结果的有意义变化.
- 解释有意义的群体间差异 (MBGD) 需要特别考虑.
- 随机临床试验 (RCT) 是评估MBGD的主要背景.
研究的目的:
- 探索和批判性地评估MBGD值的不同概念.
- 研究用于解释临床研究中治疗组之间的有意义差异的方法.
- 解决临床结果评估中忽视了群体层面的意义问题.
主要方法:
- 关于MBGD值的五个不同的观点的开发和批判性讨论.
- 使用模拟数据来分析每个观点的优缺点.
- 在患者报告的有意义改善和利益相关者的观点方面检查值.
主要成果:
- 应用个体内变化值到群体层面的差异被发现是不可持续的.
- 基于患者报告有意义改善的比例,几种观点构成MBGD框架.
- 另一个框架建议直接询问利益相关者观察到的集团间差异的意义.
结论:
- 没有一种单一的,普遍有效的方法来确定MBGD值.
- 纯粹基于数据的门是不够的;主观的利益相关者判断是必要的.
- 需要进一步的研究,以开发可靠的方法来建立MBGD.
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