WCTD2016 Abstract Topics Design a Clinical Program for Success (17 abstracts)
1Clinical Science & Consulting, ERT, USA; 2Research, Endpoint Outcomes, USA.
Background: Electronic patient-reported outcomes (ePROs) are a reliable method for collecting patient data in diabetes clinical trials and offer many advantages over paper collection; however, it is essential to consider patient preference and ease of use when employing this technology. Improving the usability of ePRO in clinical trials could ultimately reduce subject burden and improve subject engagement.
Methods: 102 subjects with type 2 diabetes were surveyed regarding their preferences for ePRO display.
Results: When presented with options for showing emphasis in a sentence, subjects thought that underlining best drew attention to emphasized words (37%), followed by capitalized (27%) or italicized (19%) lettering. Subjects were shown screens of a multi-select question formatted to read left to right (question to the left of the answers) or top to bottom (question above the answers). 38% could read and understand the screens equally. Of those with a preference, 76% preferred the top to bottom format. Subjects were shown screens of a tablet computer ePRO device with either one question per screen or several multi-select questions per screen in a matrix format. 55% preferred one question per screen because it was easier to read (65%). 45% preferred multiple questions per screen because it was faster to complete (50%). Subjects were shown two screens with back and next navigation buttons at either the top or bottom of the screen. 34% thought it was equally easy to find the buttons; of those with a preference, 64% preferred them at the bottom of the screen.
Conclusions: When possible, questionnaire designers should consider these results to incorporate patient preference into the design of ePRO instruments; potentially reducing subject burden and increasing patient engagement in diabetes clinical trials.