患者报告结局:ePRO评估在临床试验的过去、现在和未来

2017-03-12 刘佳文/张岩波 BioMed数据坊

患者报告结局(PROs)是用来评估新的医疗产品的治疗效果一种非常重要的方式。通常认为PRO评估应用于评估一些概念,这些概念要么患者非常清楚,要么从患者角度可以被很好的测量。所以人们越来越重视一些定义准确且可靠的PRO量表。此外,技术的进步已经显著的增加了临床试验中电子化PRO(ePRO)数据收集的功能和选项。从纸质数据到电子化PRO数据的转变已经增强了临床试验数据的完整性和精确性,且监管机构也

患者报告结局(PROs)是用来评估新的医疗产品的治疗效果一种非常重要的方式。通常认为PRO评估应用于评估一些概念,这些概念要么患者非常清楚,要么从患者角度可以被很好的测量。所以人们越来越重视一些定义准确且可靠的PRO量表。此外,技术的进步已经显著的增加了临床试验中电子化PRO(ePRO)数据收集的功能和选项。从纸质数据到电子化PRO数据的转变已经增强了临床试验数据的完整性和精确性,且监管机构也鼓励这一转变。在各类ePRO平台的主要区别是在基于电话的交互式语音应答系统和基于屏幕的交互系统之间。基于触摸屏的手持设备已在临床试验中用于收集远程(即异地、无人监管的)PRO数据中发挥支柱作用。常规的方法是给受试者提供一个手持设备,该设备中配有了专用的软件程序。然而,现在临床试验中出现了新兴的取代物,即自带设备(BYOD)。远程PRO数据采集(通过一个可下载的应用程序或基于网络的数据收集门户)利用受试者自己的有上网功能的移动设备已成为可能,这正是由于个人智能手机和平板电脑的广泛使用。然而,在将BYOD视为常规实用的ePRO数据收集的方法的替代物之前,仍有一些关于它科学性和实用性的问题要解决。尽管如

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    2020-07-04 ms5000001693918366

    设备

    0

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    2017-03-14 sunylz
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    2017-03-13 1e1a50a1m36(暂无匿称)

    PRO评估应用于评估一些概念,这些概念要么患者非常清楚,要么从患者角度可以被很好的测量

    0

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    2017-03-13 明月清辉

    谢谢分享,学习了

    0

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    2017-03-13 刘煜

    阅读了谢谢分享

    0

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