Presentation (CTI)

OBJECTIVES: Electronic solutions are quickly becoming the primary means of data collection in clinical trials. Though best practices for linguistically validating Clinical Outcome Assessments (COAs) are well defined, there is a lack of comprehensive instruction on translating and maintaining non-COA metatext (essential button text, navigation instructions). Similarly, though much care is dedicated to development of eCOA user interface (UI) and experience (UX), there is less attention given to translating and testing non-COA text, which can result in a diminished experience for the end user and impact data collection and participant retention.
METHODS: A cross-functional approach was applied to the translation of non-COA text used across eCOA studies regardless of indication, study design, and device type. 60 languages were identified as common across all indications, where common is defined as any language requested in more than 5 studies over 1 year. The methodology used was forward translation (FT), back translation (BT), back translation review (BTR), and on-device screen review (SSR) by in-country linguistic validation specialists. Resulting translations were added to a glossary maintained by the eCOA solution provider and applied to 10 eCOA studies involving 10-50 languages.
RESULTS: During development of the glossary, 30% of languages required minor contextual adjustments during SSR, showing the requirement for this step in addition to FT, BT, BTR. When use of the glossary was applied to later studies, the rate of changes required to metatext fell to 1%, resulting in a shorter overall timeline for language development. Languages showing the greatest improvement were non-Latin scripts and right-to-left languages.
CONCLUSIONS: Development and maintenance of a glossary of translated eCOA terms is essential for consistent UX/UI for eCOA solution end users. This should be considered by all eCOA solution providers when developing an application’s UX/UI to ensure design consistency, maintain data collection integrity and achieve maximum participant retention in electronic trials.