Linguistic Validation

PostedAugust 5, 2023

Byles-admin

Linguistic Validation Explained

Linguistic validation and cognitive debriefing are two processes designed to ensure that the Clinical Outcomes Assessments (COAs), such as Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs) and Observer Reported Outcomes (ObsROs) are linguistically, culturally, and conceptually equivalent to the original version. The process involves four key components: forward-translation, back-translation, reconciliation, cognitive interviewing, and multiple parties: translators, project managers, survey-research analysts, clinicians and in-country reviewers. To ensure a high level of precision, the translation process requires reiterative testing and validation of the translation through cognitive debriefing interviews with either native-speaking subjects or patients.

Linguistic validation and cognitive debriefing are two necessary processes for qualifying outcome assessment materials. This is not only to comply with FDA regulations, but also to ensure that patients are able to understand and relate to materials with full confidence.

The Process

Linguistic Validation is the process of investigating the reliability, conceptual equivalence, and validity of translations of patient-reported outcome (PRO) measures. Most usually, translated text is actively tested with patients in the target population and target language group through cognitive debriefing As part of the clinical trial process, this is because collecting data from trial participants is vital to determine how their abilities or feelings are influenced during the study. Alterations can be made after this stage if nuances of meaning in the source text have not been clearly expressed in the translation and understood by the respondents. Inaccurate translations can lead to copyright infringement and the retraction of permission for use by the copyright holders.

Linguistic Validation work may take between 4 – 8 months, depending on the language
and questionnaire. The process is divided into the following parts:

Forward Translation (FT) completed by native speakers of the target language, fluent in English and resident in the country where the translation is to be used. Ideally one person should be a professional translator and the other a psychologist with experience of designing psychological questionnaire measures.

Reconciliation can be completed by two blinded native translators who have no previous knowledge of the original questionnaires.

Back Translation (BT) done completely blind (i.e. with no help or information about the original English questionnaires) and independently of each other. Should be done by people who are native speakers of English and fluent in the target language.

Cognitive Debriefing should be conducted with patients from the target therapeutic area. Patients review the translation and provide their feedback. The linguists and the project teams evaluate the feedback and implement solutions to the issues encountered. After questionnaires translation and proofreading and undergoes a quality control check, the translation is officially linguistically validated.