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

ABSTRACT

Background:Patient-reported outcomesplay an essential role in evaluating the results of clinical trials. As technological advances are made throughout the industry, pharmaceutical sponsors’ ability to collect field-based patient data has greatly increased. Recently, many clinical trials areutilizing varying modes of data capture in order to enable maximum flexibility. Given the regulatory concern over the equivalence of mixed modes of administration, the need to research the use of varying devices is essential.Methods:This study reviewedthree handheld smartphone devices for conceptual equivalence and conducted usability for standard questions used in a daily pain diary. Out of ten participants, 7 were females and 3 were males with age ranging from27-70 years, diagnosed with chronic painor fibromyalgia, completed the same pain diary on three different smartphone devices.Results:Overall, participants reported no differences between these three smartphone devices and found the presentation of the diary content to be similar, if not identical, on all three devices. Conclusions: Device type had no impact on the presentation of the diary content or participants’ understanding of the diary questions