Clinical Outcome Assessments (COAs) must be designed with cross-cultural and multilingual realities in mind. This is especially so, given the increasingly global character of clinical studies. A COA that works well in the source language, usually English, may not automatically work just as well in Japanese, Swahili or Portuguese. This is where translatability assessment comes in.

This is the process of evaluating how well a COA, or any patient-reported measure, can be translated into another language without losing its meaning, function or sensitivity. It is a critical but often underestimated step in developing truly global, patient-centred instruments.

What Is a Translatability Assessment?

Translatability assessment (TA) is a proactive review of source text to identify linguistic, cultural and conceptual elements that might create difficulties during translation or use in other languages and cultures.

As opposed to problems being discovered during the translation process, or, indeed, post-translation, TA is about forward thinking and prevention. It serves to flag potential issues before they become real barriers to accurate, equivalent measurement.

It is an evaluation of how easy, or difficult, it will be to translate and adapt the content meaningfully, while maintaining the integrity of the concept.

Why Is It Done?

COAs are used to gather subjective and nuanced data about symptoms, functioning, emotions and perceptions. This makes them particularly sensitive to differing language and cultural contexts. If an item’s meaning changes during translation, the data becomes unreliable:

-            Items can be misunderstood or misinterpreted.

-            Cultural taboos can be triggered.

-            A word assumes ‘cultural coating’ during the translation process.

-            Concepts become vague or distorted.

-            Measurement inconsistency across languages.

While a COA might be valid in one locale, poor translation and an absence of translatability can undermine cross-cultural equivalence and, in turn, the validity of the data it collects.

The TA is supposed to review the source text to identify:

-            Idioms, metaphors or culturally bound expressions that may not translate well.

-            Ambiguous terms or words with more than one meaning.

-            Complex syntactic structures.

-            Concepts that may not exist or be experienced in the same way in all cultures.

The reviewing team involved in TA not only needs to apply knowledge of common linguistic challenges in specific languages, but they must also have a deep understanding of cultural patterns, such as individualism versus collectivism, communication styles and taboos.

When Translatability Goes Wrong

Poor translatability planning can lead to:

-            Failures in the translation process, such as back-translation failures. This is where the back-translated text no longer matches the source.

-            Time-consuming rework late in the project.

-            Low-quality data due to poor translation and subsequent misunderstanding

-            Regulatory pushback from authorities like FDA or EMA who require evidence of conceptual equivalence across cultures.

Poor translatability can also stem from unclear conceptual guidance, which can lead to deviations from the intended meaning.

What to Avoid

-            Assuming English phrases, including idioms and metaphors, will make sense globally.

-            Skipping TA entirely in favour of a ‘just translate it’ approach.

-            Doing the TA after translations are already underway.

-            Only doing a word-level review instead of a meaning-focused evaluation.

-            Failing to involve culturally diverse perspectives in the review process.

How TA Connects to Concept Elaboration

While concept elaboration is about making clear what each item is intended to mean, translatability is about ensuring it can be communicated successfully across languages and cultures. The two activities are closely connected. They both exert bi-directional influence on each other:

-            Without clear concept elaboration, the translatability assessment lacks direction.

-            Without a translatability assessment, the concept elaboration risks being rendered useless by poor adaptation.

Together, they form the foundation for COAs that are culturally valid and globally deployable. A good translatability assessment ensures that the voice of the patient is not lost in translation – literally or figuratively. It respects the complexity of human experience across linguistic and cultural borders.

Thank you for reading,

Mark Gibson

Leeds, United Kingdom, April 2025