Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials

Abstract

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.

Evaluation of quality of life using a tablet PC-based survey in cancer patients treated with radiotherapy: a multi-institutional prospective randomized crossover comparison of paper and tablet PC-based questionnaires (KROG 12–01)

“…In our current study, we used a tablet PC as an electronic system for PRO administration. Tablet PC-based questionnaires are portable, in contrast to IVRS or desktop computer systems [19]. Additionally, data administration using a webbased application platform and a touch screen display on a tablet PC is anticipated to be familiar to most Korean patients, as more than 38 million Koreans (over 70 % of the Korean population) were using a smart phone or tablet PC as of 2014 [20].…”

“…Currently, the feasibility of taking PRO measurements using advanced technologies appears to be increasing [5,12,19]. In addition to electronic devices provided by clinicians at hospital sites, PRO administration via a patient's own mobile computing platform has been used in several clinical trials [19,23].…”

Bring-your-own-device in medical schools and healthcare facilities: A review of the literature (Preprint)

“…That is, the BYOD policy should cater for other mobile device uses such as diagnosis [45,[57][58][59][60][61], patient monitoring, follow-up [46,[62][63][64][65][66], data collection [43,46,51,67], and medication adherence [68,69]. Integration of mobile devices into hospital systems, especially patient record management [70], including patient participation in computerized patient record management [71], is also worth policy consideration.…”

Design rationale and performance evaluation of Wavelet Health Wristband: bench-top validation of a wrist-worn physiological signal recorder (Preprint)

“…Digital operational efficiency here refers to use of digital health to increase patient adherence, trial data collection speed and efficiency, thereby reducing the time and cost to market. Electronic patient reported outcomes (ePROs) and remote patient monitoring (RPM) are good examples of how digital health has been transforming the operational workflow of biopharma and clinical research organizations (CROs) [6]. Digital biomarker development has also been a key application of digital health in the biopharma and clinical research spaces for developing new endpoints that have not previously been possible to assess, or existing endpoints that can be measured in new and possibly better ways [7].…”