Why you need linguistic validation
Get a group of people together from various countries and you’ll quickly discover that there is no such thing as a direct translation. What means one thing in English could mean something completely different in Spanish.
When performing medical studies or case studies in various regions, you need to do more than basic translation. You must also understand the context of language in each region. All this falls under the category of linguistic validation.
Defining linguistic validation
There is a growing need for translation in the medical industry. Drugs, devices, and tests are getting sent or conducted worldwide. Your Patient Reported Outcomes (PROs) depend on accurate labels and claims.
Linguistic validation is the process of taking a translated text and then adjusting it to have the equivalent meaning across all regions and languages.
Although the verbiage might translate directly, the meaning could get lost, causing people in other regions confusion.
How linguistic validation works
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommends specific methodology when it comes to linguistic validation. Here’s what the process looks like.
The first translation
1. The source text is reviewed.
First, the text must undergo a translatability review. During this review, the translator looks for potentially confusing verbiage. For example, the language service provider (LSP) will highlight any reference to a geographic region, slang, or other culture related concepts. Then, before the text is handed over to the translator, any potentially difficult areas will float to the surface.
2. The text is sent for translation.
Once the problem areas are highlighted, the text is sent to the translators. When the translators have finished their work, the project manager compares and compiles both translated texts. This is when the proofing and formatting begins.
3. A back translation is performed.
Once the translated text is complete, another translator performs a literal translation back to the source language. This translator does not have any insight or access to the original source text. The goal is to help the project manager and reviewer find any problem areas where meanings got lost in translation.
4. The translated text is corrected.
If any errors are found after the back translation, the text will be fixed. Specific names of drugs or devices will need to be reviewed by a clinical physician to ensure accuracy in each region or country.
5. The text is finalized.
Once the project manager has narrowed in on the most accurate translation, the text is brought together across all languages and finalized.
Cognitive debriefing
With the finalized text in hand, cognitive debriefing begins. This process involves showing the text to a small group of people who live in the region and speak the translated language at a mother tongue level.
The goal of cognitive debriefing is to ensure that the translated text has the same context and meaning as the source text.
The final review
Once the project manager receives the cognitive debriefing report, she has one last opportunity to make any necessary corrections to the words or context. Once the translated text is shown to mean the same thing to everyone surveyed, the linguistic validation is finalized.
The benefits of linguistic validation
If your text loses meaning across various regions, your clinical trials will suffer. You will not get accurate measurements or survey results because your audience will not properly understand what you are trying to ask.
In addition, you increase your chances of meeting the FDA and EMEA guidelines. Without linguistic validation, you will have a harder time having your clinical trials approved and expanding your market into new countries.
Getting a linguistic validation on any study, service, or product that you plan to use overseas is vital to your long-term success.
