subject in clinical trial filling out a PRO
By: Autumn On: September 09, 2016 In: Medical, Translation Comments: 0

When it comes to clinical research, patient reported outcomes, or PROs, can go a long way toward drawing conclusions. This, in turn, can offer answers that can affect the medical field immensely.

But this can’t be done without linguistic validation, since PROs are often reported in a variety of languages. Read on to learn exactly why linguistic validation is such a necessity.

The Point of Linguistic Validation

PROs can be obtained through various instruments, such as patient questionnaires. But those instruments are only helpful when patients fully understand them, regardless of the language they speak. That’s where linguistic validation comes in.

The point of this process is to make sure there are no translation issues that make it difficult for patients to correctly comprehend the questions. After all, with even a single translation mistake, their answers might not be accurate and could invalidate any research related to them.

How the Process Works

There are several steps involved in linguistic validation including forward translations, reconciliation, back translation, harmonization and cognitive debriefing.

Basically, a set of multiple translators translate the same questionnaire or other instrument being used in the clinical trial. These translations are then compared and combined into one version, which is then translated back to the original language by a set of different translators.

Any mistakes can then be remedied and the final, accurate translation determined. This is especially important when questionnaires are offered in multiple languages, as is the case with most assessment instruments that collect PROs.

Why Linguistic Validation Matters

The main issue that researchers are trying to avoid with PROs is the possibility of patients interpreting the document incorrectly. This is usually caused by translation errors.

The mistranslation of a single word could change the meaning of a question, leading to invalid answers, which could jeopardize an entire pooling group. This can waste both time and resources and cause delays in researchers’ ability to draw conclusions that could impact the medical field.

Proofreading PROs is also very important. Even having a comma in the wrong place or forgetting to type a single word can make a question hard to understand and answer, so spelling mistakes as well as grammar mistakes need to be avoided.

Additionally, as with any translation, in order to allow for valid pooling and comparison, PROs need to be both conceptually and culturally equivalent. This is why translation professionals often localize their instruments for each specific target audience during the linguistic validation process of PROs.

You probably already knew how important professional translation is, especially for medical and scientific documents for research purposes. But now you can also see how the process of linguistic validation works and why it’s so crucial for patient reported outcomes.

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