Linguistic
Validation



Linguistic Validation Services


Translation and Linguistic Validation of Patient Questionnaires at WORDSMITH LINGUISTIC SOLUTIONS

A good translation is not intended to be just the replacement of one language by another; it should follow the authentic meaning and should be culture specific too.

But this is just for the common translation.

When we talk of Patient Reported Questionnaire used in the clinical trials, it demands a balanced and well ordained cultural value along with the correct translation. For instance, if the term ‘bowling’ used in Quality of Life Questionnaire comes to mean the ability to perform sports activities, just a simple translation will not do the purpose as there is a huge population that will not be able to consider bowling as a typical sport activity. Thus, proper localization (for a particular language and region) would demand another activity with equal construct value.

Thus, it is imperative for a patient reported questionnaire to be culturally appropriate along with linguistically validated translations. Otherwise, the instrument can affect the accuracy of the research data.


Outlining of Linguistic Validation Process

Since the inception of the new millennium, globalization has speeded high and along with other research devices, clinical trials have also corralled global character. Authorities like FDA and EMEA have set new and strict guidelines for using Patient Reported Outcome (PRO) measure endpoint from international clinical trials to support the brand claim.

Just recently, FDA has clearly made it imperative for all the clinical research sponsors to provide the evidence and the measurement properties of instrument are adequately similar between all the versions to be used in the trial.


Linguistic Validation Process

WORDSMITH LINGUISTIC SOLUTIONS ensure to follow the process and methodology that is recommended by the International Society for Pharmacoeconomics and Outcome Research (ISPOR).


Linguistic-validation flowchart

To begin with, the questionnaire is abided to a Translability Review to approach any potentially challengeable concept and words that may require to be localized during the translation. On the basis of Translability Review, detailed instructions are prepared for our linguistic team with thorough guidelines and key concepts with their meanings and explanations so as to deal with any ambiguity that might arise.

The next step is the preparation of two forward independent translations. Then comes reconciliation, during which, the Project Manager compares and prepares a unified translation by comparing the two forward translations. This step also includes thorough proofreading and formatting which we call Quality Management.

Then comes back translation which is done by a new translator absolutely alien to the original instrument. The back translation is important as well as necessary to confirm the accuracy and pin point potential alterity, if there is any.

Then we review the source, translation and back translations simultaneously and edit the translations to remove any alterity.

Now, we have the correct translation on our table. Moving forward and keeping in mind the condition specific instrument, we take the help of a clinician practicing in target country in the related field. This clinician verifies the reference to the medical conditions, symptoms and disorders are expressed using the terms that are used by clinicians with patients.


Harmonization

The next step is called Harmonization. All the variances are identified and resolved and thus uniformity among all language translations are created in.


Cognitive Debriefing

Now, let us talk about Cognitive Debriefing. Tomake sure that the validated instrument is culturally apt and relevant to the population intended to, we hire local professional experts in differing interviewing techniques extending from Psychiatry to Social Working (just to name the two). Cognitive Debriefing interviews are conducted among 5 to 10 subjects or patients that bespeak the potential instrument’s respondent population. After this, an interview report is prepared.

The translation is then proofread by another linguist, to ensure that we have not missed anything in all these steps.

The translation is then finalized by the Project Manager after thoroughly reviewing the Cognitive Debriefing report. After a final proofreading, the translation is sent to customer.

Finally, we update the translation memory making sure that you save on your next order with us.


Our Chairs

The widely extensive network of experts extending from Linguists, Project Managers, Clinicians (just to name a few) associated with us all around the world enable us to make our clients feel satisfied to the core.


We have specialists working with us from the following medicine branches:

Advantages of Linguistic Validation with WORDSMITH LINGUISTIC SOLUTIONS

At WORDSMITH LANGUAGE SOLUTIONS, we make sure that the customer feels absolutely satisfied regarding the correct translation of all items and the interpretation at par with the region and target population. The data can be pooled validly across the international sites and the process meets FDA and EMEA guidelines.

We have a lot more to say about Linguistic Validation Service, we have a portfolio which we’d like you to see, we’d like to discuss this service one-on-one. Before you start allocating a new team to your next linguistic validation project, we’d request you to talk to us once and check how you can benefit from our experience. To send us a message please click here, or you can call us at +91-8727810000.