“Bring Your Own Device” (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials?

Abstract

Field-based patient-reported outcome (PRO) assessments, including measures of signs, symptoms, and events that are administered outside of the research clinic, can be critical in evaluating the efficacy and safety of new medical treatments. Collection of this type of data commonly involves providing subjects with stand-alone electronic devices, such as smartphones, that they can use to respond to assessments in their home or work environment. Although this approach has proven useful, it is also limited in several ways: For example, provisioning stand-alone devices can be costly for sponsors, and requiring subjects to carry a device that is exclusively dedicated to the study can be burdensome. The "Bring Your Own Device" (BYOD) approach, in which subjects use their own smartphone or Internet-enabled device to complete field-based PRO assessments, addresses many of these concerns. However, the BYOD model has its own limitations that should be considered. In this article, representatives of the ePRO Consortium review operational, privacy/security, and scientific/regulatory considerations regarding BYOD. We hope that this review will allow researchers to make informed decisions when choosing methods to collect field-based PRO data in future clinical trials. Additionally, we hope that the discussion in this article will establish a research agenda for further examination of BYOD approaches.

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

“…The myriad of policies and regulations relating to the implementation of mobile device use can lead to several issues, particularly when there seems to be a pattern of having an intervention (policy or technical) for every issue, possibly making BYOD an aggressive investment [5,6,23,24,26,28,29,[40][41][42][43]. It is also unclear how, after implementing all the policies and regulations, mobile devices are still able to provide convenience desired by users.…”

Validation and equivalency of electronic clinical outcomes assessment systems

“…9 Therefore, it is recommended that expert screen review and usability testing be performed on the smallest permitted screen size/resolution, and it is also recommended to include a range of devices, including smallest and largest permitted sizes, and both android and iOS devices. 9,15…”

Measurement of equivalence using a patient-reported daily pain diary across three smartphone devices

“…Each participant self-reported their experience with different technologies and is presented in Table 2. A majority of participants (8) did have internet access at home, with five accessing the internet at home via a laptop or desktop computer, three via a tablet, and five via their smartphones. The majority of participants (6) reported owning a smartphone that was either Apple (1) or Android (5).…”

“…In addition, there are many privacy, security and operational concerns to pay close attention to, such as data transfer security, lost or stolen devices, internet availability, device ownership, design and support to consider prior to deciding if a BYOD approach is approriate for a clinical trial. 2,8…”