Why Linguistic Validation of Questionnaires is Crucial for Accurate Data
By Amanda Ryan, President, G3 Life Sciences
There is no room for error when it comes to clinical assessments. That’s where linguistic validation of questionnaires for these assessments comes in, ensuring the message is portrayed the same way across the world.
Piece of cake.
Icing on the cake.
That takes the cake.
These are all expressions that people in the US hear and use often. However, if these expressions were to be translated literally into another language, it certainly wouldn’t have the same effect. This applies to expressions in other languages that wouldn’t make sense to English speakers if they were directly translated.
While this type of miscommunication is harmless, there are other expressions that aren’t so forgiving when translated literally. It can do much more than just cause confusion, especially in health– and research-related industries.
Regardless of how innocent the expression may be, it can be translated in a way that is understood across all languages.
What Is Linguistic Validation?
Linguistic validation happens when the meaning, rather than the words, of a phrase is translated so the target population obtains the same understanding as the concept being translated. It ensures communication between languages is completely uniform, despite cultural and linguistic differences.
Why and When Is it Necessary?
Linguistic validation is used in clinical trials as a specialized translation process for clinical outcome assessments (COAs), which include patient-reported outcomes (PROs), clinician-reported outcomes (CROs), performance outcomes (PerfOs), and observer-reported outcomes (ObsROs). The FDA defines COAs as “a measure that describes or reflects how a patient feels, functions, or survives.”
This data includes highly sensitive materials that require the highest levels of accuracy and quality. Linguistic validation helps achieve those high levels of accuracy and quality by ensuring the same concept is translated equally across all target languages for specific patient populations. This way, when patients complete assessments, they understand the intent of the questions and can respond accordingly.
How Does Linguistic Validation of Questionnaires Work?
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommends following this four-step process for a full linguistic validation of a patient-reported outcome:
- Concept definition: A specialist identifies and defines any items that may be problematic in translation.
- Dual-forward translation and reconciliation: Two native-speaking linguists translate the document following the concept definitions. Once complete, a third forward translation is created using the best word choice based on context and concept definitions from each completed forward translation.
- Back translation and resolution: The reconciled forward translation is translated back into English and compared to the original statement to ensure accuracy.
- Cognitive interviewing: The target language is tested among individuals of the target study population in the target language to determine whether the audience will understand the questionnaire the same way the original would be understood.
In addition, some COAs are under strict copyright with specific translation requirements, which require additional steps.
The linguistic validation process is necessary in ensuring target audiences are understanding concepts the same way across all languages. Research can’t be validated using data that collectively didn’t get the same message across to various audiences. This process ensures individuals understand the intent and meaning of each question to respond appropriately—every time.
Interested in linguistic validation services from G3? Piece of cake. Contact us here.