Abstract
Patient reported outcome (PRO) measures typically undergo a precise and detailed translation process which involves the input of translators, investigators, project managers and developers in order to produce the most accurate and fluent translation possible. In order for the pooling of data from international clinical trials to be possible, it is important that translations of a PRO measure mean the same to all respondents, not just in terms of the phrasing, but also in terms of the intensity and nuance of the phrases used. It is often the case that terms used frequently in PRO measures will have a direct and literal translation into the target language. However, problems can occur when terms used in the source text are culturally bound – i.e., when the direct translation of a term has a different meaning than that of the source text, in terms of intensity or connotations, or is used in a different way. For example, the term ‘frustrated’ has a direct translation in most languages; however, this term has a stronger meaning in some countries and can refer to a mental health issue. Issues can also arise when there is no equivalent of the source term in the target language. We will discuss common terms, expressions and nuances that are frequently used in PRO measures and how their meaning can be different across varying languages and cultural backgrounds. We will examine how to pre-empt these issues and how to avoid the mistranslation of culturally bound terms, by discussing the importance of detailed concept elaboration documents, input from the instrument developer, and in-depth pilot testing and cognitive debriefing. By using these methods it is possible to accurately anticipate these potential issues and explore alternative ways of conveying the intended meaning.
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