OBJECTIVES

: Patient Clinical Outcome Assessments (COAs) are sometimes required to investigate participant use of medications and substances outside of the trial drug. The terms used in these cases can often cause interesting diversions when adapting the questionnaires for different cultures and languages. For example, the term ‘drugs’ often describes both prescribed and illicit drugs, without always specifying the type. Homeopathic drugs may also be covered in patient questionnaires and this often leads to difficulties in obtaining cultural equivalence. This study evaluates the potential pitfalls associated with localisation of ambiguous or culturally-specific terms in this area.

METHODS

: RESULTS

: Among the results, 71% retained ‘drugs’ when translating the general term, matching the ambiguity of the source, 21% specifically translated this as ‘illicit drugs’ or ‘medication’ and 9% as ‘illicit drugs and medication’.

In 71 translations, the term ‘homeopathic medication’ was understood in over half of target countries, while the remaining country participants required further explanations due to this treatment not being readily available, being unknown for cultural or personal reasons.

CONCLUSIONS

: When considering translation of more general terms referring to medication, it is important that we ensure the context is clear on all sides to avoid mistranslation. The safest option would be to specify the type of drug, allowing for the most accurate translation.

It is also important to consider that not all medication types, such as homeopathic medication, will be relevant across all countries, and translations should be localised where possible.

The results also demonstrate the need for Back Translation and Cognitive Debriefing to ensure accurate Linguistic Validation and a reduced need for edits.