使用ICH估计和框架来改进对互联网干预中治疗效应的解释
Manuel Heinrich1, Pavle Zagorscak2, Johannes Bohn2
1Division of Clinical-Psychological Intervention, Department of Education and Psychology, Freie Universität Berlin, Berlin, Germany. manuel.heinrich@fu-berlin.de.
ICH E9(R1) 估计附录为在临床试验中定义治疗效果提供了一个框架. 将该框架应用于基于互联网的干预 (IBI) 试验对于提高结果的有效性和可解释性至关重要.
科学领域:
- 临床试验方法论 临床试验方法论
- 数字健康干预措施 数字健康干预措施
- 药学研究 药学研究
背景情况:
- 国际协调理事会 (ICH) E9(R1) 估计附录提供了一个标准化的框架,用于定义临床试验中的治疗效应.
- 这一框架在制药研究中被广泛采用,但在基于互联网的干预措施 (IBIs) 的试验中未得到充分利用.
研究的目的:
- 引入ICH E9 ((R1) 关于估计费的附录,用于研究人员进行基于互联网的干预试验.
- 突出估计在提高该领域研究质量的重要性.
主要方法:
- 文献综述和ICH E9的概念分析 (R1) 附录.
- 将估计和原则应用于基于互联网的干预试验的背景.
主要成果:
- ICH E9 (R1) 附录为定义估值提供了一个强大的框架,这些估值是预期估计的特定治疗效应.
- 附录中的原则是直接适用的,对IBI试验的设计和分析非常有益.
结论:
- 估计对于提高基于互联网的干预试验中效果估计的可解释性,相关性和有效性至关重要.
- 采用ICH E9 ((R1) 框架将加强数字健康研究的科学严谨性.
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