Linguistic Validation Services
Conceptual equivalence and international harmonization for global clinical trials
Ensure Accurate COA Data with Linguistically and Culturally Appropriate Questionnaires
When conducting global clinical trials, questionnaires are often only available in English. Good data management is integral to clinical outcome assessments (COAs) so it’s imperative that the participants clearly understand the instruments being used.
Professional Linguistic Validation Services
Linguistic validation ensures that global clinical trial participants conceptually and equivalently comprehend the translated instruments in all languages, allowing for a single statistical analysis of combined multinational data.
Our ISPOR-compliant linguistic validation services involve phases of assessment, translation, harmonization and cognitive debriefing to ensure conceptual equivalence and international harmonization.
The ISPOR ‘Principles of Good Practice’
The ISPOR ‘Principles of Good Practice’ detail 10 steps that include: Preparation, Forward Translation, Reconciliation, Back Translation, Back Translation Review, Harmonization, Cognitive Debriefing, Review of Cognitive Debriefing Results and Finalization, Proofreading, and Final Report.
Below is an introduction to the core phases.
The translatability assessment is a preparation or pre-translation check to mitigate issues that would arise from either culturally irrelevant or non-universally accepted conventions such as date and time formats.
The resolution of these issues beforehand will save time and errors and reduce bottlenecks in global clinical trials. The translatability assessment is a standardization of the instruments through the removal or adaptation of nuanced phrases and content.
It’s objective is to make them more global ready, and therefore easier to translate by using universally excepted concepts and conventions.
Linguistic translation involves two phases of translation—forward and back translation.
First is the translation of the clinical instrument into the foreign language(s), also known as a forward translation.
The forward translation should ideally be done by a translator specialized in health and familiar in the therapeutic area and it should be done with an emphasis on conceptual equivalency.
Simple, clear language should be used to keep the questions clear and avoid ambiguity or confusion. Jargon should be avoided so the translation is easily understood by a broad audience as opposed to technical or medical terminology that would be written only for clinicians.
Two forward translations of the same text are sometimes done and then reconciled into one.
Back translation is often recommended by the institutional review board (IRB) or the ethics committee (EC) in various countries for regulatory approval.
It is used as an additional safeguard against errors, ambiguities or confusion and improves the validity, accuracy, and readability of the translated instrument.
In this step, the previously translated and reconciled text is given to a separate translator who translates it into its source language. Hence the name back translation.
The back translator has no knowledge of the original text in order to minimize bias. After the back translation is complete, the project manager compares it against the original text for discrepancies in meaning. This is known as a back translation review.
The cognitive debriefing phase serves as a test of the translated instrument to gauge the clarity of the questionnaire and comprehension of sample participants in a real-world context.
The U.S. Food and Drug Administration defines cognitive debriefing as a qualitative research tool for determining whether concepts and items are understood by patients in the same way that instrument developers intend.
Respondents are asked what their understanding of the instrument questions are. Modifications are made where necessary to ensure clarity and participant comprehension.