Presentation (CTI)

OBJECTIVES: As technology advances, conceptual frameworks evolve, and cultures become more inclusive and diverse, we have seen a significant shift in the recognition and widespread use of certain concepts and terminology among the general population. This can impact the language in Clinical Outcome Assessments in various ways as updates to the source and translations may be required to reflect up-to-date vernacular, disease treatment, and lexical/grammatical standards.
METHODS: A selection of COAs from multiple therapeutic areas was analyzed to determine the requirement of linguistic or conceptual changes in the source document and were categorized based on update rationale. Source document changes were then analyzed in terms of global translation requirements to ensure equivalence in the target versions.
RESULTS: Results indicated that changes required to the COAs updating key concepts prompted further linguistic changes in the corresponding validated translations. Taking the International Index of Erectile Function as an example: version two updated the definition of sexual intercourse from ‘vaginal penetration’ to ‘sexual penetration’ to allow the COA to be used more widely and be applicable to the LGBTQIA community. When making the necessary updates to the translations, linguists highlighted further updates due to new, inclusive terminology used in the target language.
CONCLUSIONS: Languages, concepts, and medical treatments evolve, and as such a COA and its translations may need to be updated to ensure they remain fit for purpose in the population being assessed. Instrument owners should monitor their libraries and have consistent versioning in place to track source and translation updates. Language Service Providers should have documented processes for reviewing and updating existing translations to ensure they remain linguistically, culturally and conceptually appropriate.