Arrow Translation’s New Practices in the Translatability Assessment of Patient-Reported Outcome Measures

At Arrow Translation, we are excited to share a recent article released in the translation and linguistic validation industry. This article, authored by the International Society for Quality of Life Research (ISOQOL) Translation and Cultural Adaptation Special Interest Group (TCA-SIG), is titled "New Practices in the Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures." It was published in The Journal of Patient-Reported Outcomes (JPRO) at the end of February 2024. The authors aim to fill the research gap in translatability assessments and reach a consensus on new practices through expert collaboration.

As research becomes increasingly globalized, it is essential to have culturally appropriate and locally relevant Patient-Reported Outcome (PRO) measures. There are existing guidelines (such as ISPOR and FDA) for conducting linguistic validation of PROs to ensure their use in global clinical studies. Translated versions of PRO measures developed with rigorous methodologies generally meet the regulatory requirements for content validity and conceptual equivalence. However, this process often exposes challenges related to adapting the source tool in areas like formatting, instructions, concepts, idioms, response scales, or demographic items.

By the time these issues are uncovered, modifying the source tool is often too late. To address this, the TCA-SIG authors recommend conducting translatability assessments during the PRO development stage to ensure issues are identified early on, preventing difficulties during the official use, translation, and cultural adaptation phases.

While some researchers believe that translatability assessments can be conducted at any stage of the PRO tool lifecycle, including post-implementation, the authors acknowledge the various uses of such assessments in research but emphasize that conducting them early in the tool development process is critical to achieving true cultural and conceptual globalization.

This paper is a must-read for anyone involved in translation and cultural adaptation, particularly questionnaire developers. We’ve all experienced the difficulty of trying to express phrases like "having butterflies in your stomach" in a different language (hint: it’s not easy!).

At Arrow Translation, we’re committed to supporting the global healthcare community with our expertise in linguistics, translation, and cultural adaptation to ensure that PRO measures are truly translatable, accurate, and relevant across diverse cultures. By embracing the new practices outlined in this research, we aim to contribute to a future of seamless global communication in clinical trials and research.

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