Coons Stephen Joel, Eremenco Sonya, Lundy J Jason, O'Donohoe Paul, O'Gorman Hannah, Malizia William
Critical Path Institute, Tucson, AZ, USA,
Patient. 2015 Aug;8(4):301-9. doi: 10.1007/s40271-014-0090-z.
Patient-reported outcomes (PROs) are an important means of evaluating the treatment benefit of new medical products. It is recognized that PRO measures should be used when assessing concepts best known by the patient or best measured from the patient's perspective. As a result, there is growing emphasis on well defined and reliable PRO measures. In addition, advances in technology have significantly increased electronic PRO (ePRO) data collection capabilities and options in clinical trials. The movement from paper-based to ePRO data capture has enhanced the integrity and accuracy of clinical trial data and is encouraged by regulators. A primary distinction in the types of ePRO platforms is between telephone-based interactive voice response systems and screen-based systems. Handheld touchscreen-based devices have become the mainstay for remote (i.e., off-site, unsupervised) PRO data collection in clinical trials. The conventional approach is to provide study subjects with a handheld device with a device-based proprietary software program. However, an emerging alternative for clinical trials is called bring your own device (BYOD). Leveraging study subjects' own Internet-enabled mobile devices for remote PRO data collection (via a downloadable app or a Web-based data collection portal) has become possible due to the widespread use of personal smartphones and tablets. However, there are a number of scientific and operational issues that must be addressed before BYOD can be routinely considered as a practical alternative to conventional ePRO data collection methods. Nevertheless, the future for ePRO data collection is bright and the promise of BYOD opens a new chapter in its evolution.
患者报告结局（PROs）是评估新型医疗产品治疗益处的重要手段。人们认识到，在评估患者最为了解或最适合从患者角度进行衡量的概念时，应使用PRO测量方法。因此，人们越来越重视定义明确且可靠的PRO测量方法。此外，技术进步显著提高了临床试验中电子PRO（ePRO）数据收集的能力和选择。从纸质数据采集向ePRO数据采集的转变提高了临床试验数据的完整性和准确性，并且受到监管机构的鼓励。ePRO平台类型的一个主要区别在于基于电话的交互式语音应答系统和基于屏幕的系统之间。基于手持触摸屏的设备已成为临床试验中远程（即非现场、无监督）PRO数据收集的主要方式。传统方法是为研究对象提供一台装有基于设备的专有软件程序的手持设备。然而，临床试验中一种新兴的替代方法称为自带设备（BYOD）。由于个人智能手机和平板电脑的广泛使用，利用研究对象自己的联网移动设备进行远程PRO数据收集（通过可下载应用程序或基于网络的数据收集门户）已成为可能。然而，在BYOD能够被常规视为传统ePRO数据收集方法的一种实用替代方案之前，有许多科学和操作问题必须得到解决。尽管如此，ePRO数据收集的未来前景光明，BYOD的前景为其发展开启了新的篇章。
