OBJECTIVES: Today, around 50% of clinical trials capture clinical outcomes assessments electronically. For the initial paper to electronic migration, cognitive debriefing and usability testing (CD/UT) is typically conducted to ensure the meaning of assessments are not altered. However, what happens when we move between different electronic executions is less clear. While there is some variation across license holders, a significant portion request CD/UT for each electronic device. Whether this is needed, and how it would work using Bring-Your-Own-Device (BYOD) where there is significant variation in devices used, is unknown.

METHODS: To better understand the level of variation between different electronic devices, we synthesized results from 7 conceptual equivalence and usability studies conducted internally by ERT between 2017-2019. To assess equivalency of generic diaries using a range of response scales across different devices (handhelds, tablets, and PCs), 4 studies included in-person qualitative interviews with adult participants and 3 used expert screen review.

RESULTS: All qualitative interview studies found that devices were easily and similarly usable by participants. Participants reported no differences in their understanding of or user experience with the diary content. All expert screen review studies similarly concluded no differences that would change the meaning of diary items, and that cognitive understanding and diary responses were maintained between devices.

CONCLUSIONS: This data supports conceptual equivalence and usability of common diaries across various devices, demonstrating that device type would not influence how participants think about or answer items. Together with mounting evidence in the literature, this suggests that conducting routine CD/UT for each device may not be necessary when using proper eCOA migration and best practices. Obtaining an industry consensus on CD/UT requirements for electronic-to-electronic migrations is critically urgent given the increase in home assessments due to the COVID-19 pandemic and resulting uptake in BYOD studies where there is little control over device type.