Linguistic Validation



Language and translation


A specific language is acquired and not inborn. It is one component of culture that largely defines and is defined by the society that employs it.


Translation, an act of bilingual communication, is only partially founded on parallelisms in expression. It depends almost entirely upon parallelisms in thought and context. Its main problems originate in the ways that representations of various kinds of material are expressed in different languages. Its primary aim is to ensure that the information content of a statement remains unchanged despite changes at the level of expression.


Translation involves three major elements, all of which have subjective as well as objective aspects. The first is represented by the communication between the original author, the translator, and the user of the translation. The second is the subject matter of the communication (the context of the situation in its broadest sense). The third is the application of linguistic competence to this context.


Linguistic competence, as well as knowledge and interpretation of contexts in a foreign culture, depend upon the translator or the translation team. Such competence is the expertise of the MAPI Institute.


From translation to linguistic validation


Language is a means of communication that is specific to each culture or ethnic group, if not to each individual. Patient-Reported Outcomes (PRO) instruments use language as a means to collect data. Using PRO instruments developed in a single language in an international setting implies translation from one language to one or several others and can be a highly subjective operation.


With increased international collaboration and the growing use of PRO in research ― clinical trials, epidemiological investigations, and clinical practice ― the need for international methods of measurement has expanded.


Most instruments have been developed in English. However, in order for an instrument to be used in international studies, it is necessary that it addresses the same concepts in all languages in order to make it possible to pool data and compare results across countries. The consistent international interpretation and analysis of results is only possible if the data are from “one instrument.”


Many questionnaires have already been translated for use in other countries and/or cultures, and worldwide regulators are rightly concerned about their validity in measuring the same concepts.


The European Agency for the Evaluation of Medicinal Products has clearly voiced these concerns as one of its key issues: “Are HRQL instruments internationally validated?” 1. Since May 2004 this question has become even more critical as the EU now includes 25 countries and some of them are home to several culturally diverse populations.