Those of us in the translation and linguistic validation industry rejoiced at the recent publication by the International Society for Quality of Life Translation and Cultural Adaptation Special Interest Group (ISOQOL TCA-SIG). Their article, Emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures was published at the end of February by the Journal of Patient Reported Outcomes (JPRO). The authors aimed to address the need for research on TA (as literature up until this date had been scarce) and to bring industry experts together to collaborate and reach an agreement for emerging good practices in conducting and documenting TA.
With the increasing globalization of research, there’s a growing need for Patient-Reported Outcome (PRO) measures that are both culturally appropriate and meet the requirements to evaluate treatment benefit and health-related quality of life in different cultures. There is existing guidance (ISPOR, FDA) on the recommended process to translate (“linguistically validate”) PROs for use in global clinical studies, and the translations developed using this rigorous methodology are very likely to meet regulatory requirements in terms of content validity and conceptual equivalency. However, this process “often reveals difficulties with the source instrument when adapting the format, instructions, concepts, idiomatic expressions, response scales, or demographic items for use in different languages.” 1
In recognizing that at that point it is too late to make modifications to the source instrument, the recommendation from the TCA-SIG authors is to perform a translatability assessment at the PRO development stage, before it is finalized and ready to be used in clinical trials or be translated and culturally adapted into other languages/countries.
There are some researchers who argue that TA could be done at any time during the PRO instrument life cycle, including a retrospective assessment. The authors agree that there may be many different uses for TA in research, and a retrospective TA of an established (psychometrically validated) tool may aid in making decisions for instrument selection, for example. However, the recommendation is that, in terms of adapting instruments to other cultures, of truly “globalizing” a measure—culturally and conceptually—the translatability assessment should be performed as early as possible, during the instrument development stage.
This paper is a “must read” for anyone involved in translation and cultural adaptation, but most of all for those in questionnaire development. We’ve all experienced that disastrous moment when one is trying to convey “butterflies in the stomach” in, say, Korean (hint: with major difficulty!).
Follow the above link to access this important paper.