Clinical Trials / Linguistic Validation

Linguistic Validation: What You Need to Know

Linguistic ValidationLinguistic validation is a technique of reviewing and validating the accuracy, reliability, and equivalency for measurements of patient-reported outcomes (PROs). These outcomes, directly reported by patients, help determine the usefulness and efficacy of various treatments. Coming in the form of questionnaires, forms, and interviews they frequently look at symptoms, health status, quality of life (QoL). Since this information can often be highly subjective, translation can be challenging. With the globalization of clinical trials and research, this challenge is even more prominent.

The goal of linguistic validation, the translation of these PRO instruments, is to maintain cultural and linguistic equivalency. The process of linguistic validation is one of the most complex tasks in the translation industry. These methods of measurement must be translated for a wide variety of users spanning numerous cultures and education levels. In order for companies to make various claims regarding the effectiveness of a given treatment, proper PROs must be able to support it in addition to scientific or clinician claims.

How Does Linguistic Validation Work?

Initially, two linguists work independently to create two separate translations. These translations are completed by translators who are native speakers for the target language. Once they have been completed they will both be handed over to the reconciliator. This important role is also performed by someone who is a native speaker of the target language. They are required to review and update the document multiple times throughout the validation process.

During the reconciliation process, the two translations must be made into a single draft for review. This is done by using the best parts from the two individual translations. Once again two independent translators, this time native speakers of the source language, will then back-translate the document. The back-translation serves as a way to compare the translated text to the source document, to see if any important information has been lost in translation. This review, also known as a comparative review is performed by a native speaker of the source language who has Comparative Review Training.

The draft is updated by the reconciliator with any recommended changes and sent to be reviewed by a health care professional of the target location and user. A small sample of the targeted audience is interviewed to determine the readability and relevancy to see if they would change any of the wording. The reconciliator will review the responses and make any necessary alterations before being delivered to the customer.

Regulatory Requirements

With each passing year, the demand for linguistic validation is growing. In 2009, the FDA issued Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. It is emphasized that any measurable tool be tested for content validity for the specific population, condition, and treatment. When addressing the issue of patient understanding, and testing the FDA says:

The FDA’s evaluation of these procedures is likely to include a review of a cognitive interviewing report containing the script used in patient cognitive interviews, the interview transcripts, the readability test used (if applicable), the usability testing process description (if available), the cognitive interviews analysis, and the actions taken to delete or modify items, response scales, or patient instructions in response to the cognitive interview or pilot results

When an instrument designed to measure PROs has undergone modification to target a different population it is important that the validity be tested and ensured once again. With clinical trials being performed on such a global scale throughout the life science industry, getting it done right the first time can help avoid costly reworks later on.

Are you looking to learn more about linguistic validation and how CSOFT can help your enterprise? Visit our website www.csoftintl.com or contact one of our linguistic validation experts

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