However, past research examining the comprehension of information presented on computer monitors has reported mixed results when considering the impact of the requirement to scroll to retrieve information. Previous studies have provided some evidence on the equivalence of the PROMs after migrating from paper to electronic formats. When collecting PROMs using BYOD, the screen size and resolution of the participants’ devices may vary, and this may introduce the requirement for the user to scroll the screen to reveal both the question and response options for some or all PROM items. Due to smartphone screen size, ePRO solution providers typically aim to present a single PROM question per screen and to ensure all content is displayed without the requirement to scroll. However, the drive to make clinical studies more patient-centric has led to increasing interest in collecting PROMs using the participants’ own device (bring your own device: BYOD) with the aim to make PROM collection more convenient. Many clinical trials provide an electronic mobile device (provisioned device: PD) of a common make and model to all participants, to ensure that PROM presentation is identical for all participants. Because most PROMs were originally developed and validated in pen-and-paper forms, migrating a PROM to an electronic format (ePROM) requires care to ensure the measurement properties of the original instrument are unaffected by the change in format.
This has been driven by the availability, low cost, and reliability of modern mobile devices such as smartphones and tablets, along with the requirement to improve the integrity and quality of data collected while limiting missing data entries and ensuring the timeliness of PROM completion.
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Īn increasing number of clinical research studies employ electronic formats to collect PRO measures (PROMs) in field-based and in-clinic settings. In the last two decades, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have progressively contributed to patient-focused drug development by requiring PRO endpoints in new drug applications and including data from PROMs in drug labelling.
Patient-Reported Outcome (PRO) measures have been increasingly gaining momentum in clinical outcome research because of recent movement toward patient-centeredness in both clinical practice and research.
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