Presentation (CTI)

OBJECTIVES: Ensuring conceptual equivalence is the key target of linguistic validation (LV) of clinical outcome assessments (COAs). However, this process becomes more complex in linguistically underserved languages where standardised terminology, trained linguists, and direct conceptual equivalents may be limited. This study aimed to characterize lexico-grammatical gaps emerging during the translation of PROs into Lao, Khmer, Tigrinya and Kinyarwanda, and to examine how these gaps were addressed within the linguistic validation process.
METHODS: A series of linguistic validation projects involving PRO measures were conducted across four low resource languages. Processes followed established LV methodologies, including concept elaboration development, dual forward translation, reconciliation, dual back translation, and cognitive debriefing. Linguistic issues identified through back translation review (BTR) and cognitive debriefing results review (CDR) were systematically analyzed using a qualitative thematic approach identifying recurring linguistic and cultural challenges.
RESULTS: For concepts without direct equivalence, conceptual shifts occurred, including linguistic or semantic broadening and narrowing. Challenges also arose in preserving distinctions between related mental states and between internal states and their observable expressions.
Consistent patterns were observed in scales and response options related to degree, frequency, and intensity, reflecting similar types of gaps. Broader challenges included limited availability of trained medical translators and differing cultural frameworks influencing interpretation.
Mitigation strategies included robust concept elaboration documents, iterative clarification with instrument owners, and expanded cognitive debriefing probes to assess conceptual understanding in languages with finite lexicon. In some cases, consensus-driven adaptations were required to maintain conceptual equivalence while ensuring cultural relevance.
CONCLUSIONS: Maintaining conceptual equivalence in linguistically underserved languages requires a flexible, context-sensitive approach beyond standard LV workflows. Proactive planning, close collaboration with local experts, and enhanced quality control are critical to ensuring culturally appropriate translations. These findings underscore the need for evolving methodological guidance to support inclusive global research across linguistically diverse populations.