A critique of the linguistic validation process for Patient-Reported Outcomes and Quality of Life instruments.

Article by Associate Consultant Mark Gibson – Full Text As a Report Available Soon

The linguistic validation process is required to ensure that translated versions of a source text contain conceptual, semantic and pragmatic equivalents to the original source text. Linguistic validation can also assure that the translated content is culturally appropriate, relevant and meaningful for the document to be used in the target countries. Over the past 20 or so years, the linguistic validation process has been implemented in the area of clinical trial documentation, particularly Patient Reported Outcome measures for administration in clinical trials, as pioneered by organisations such as MAPI Research Institute in France. As many large-scale clinical trial programmes are conducted in non-English countries on an increasing basis, the need to translate and adapt clinical trial documentation for use in other than the source language has risen in demand. This is particularly so since most clinical trial documentation, such as PRO measurement tools, originated in the English language.

There are two kinds of linguistic validation:

i)                    inter-lingual validation,  that is validation of questionnaires translated into other languages, such as an instrument originating in US English and is to be used in European variants of French, Spanish and Portuguese.

ii)                   intra-lingual validation, that is linguistic validation of questionnaires ‘translated’ into varieties of the same language, such  as a questionnaire originating in US English, to be used in other English-language countries, such the UK, Australia, Jamaica, etc.

Both kinds of validation require slightly different processes and methodologies, as are presented below.

Since most PRO and QoL documents originate in US English, for an instrument to be available in other languages, then linguistic validation helps make sure that the foreign language versions address the same concepts in all languages and offer measurable equivalence between languages. This uniformity, or harmonisation, across languages is vital to be able to pool data and compare results robustly across countries in which a given study is taking place. Therefore, the aim of harmonisation is to produce one instrument in numerous languages. Linguistic validation of each language version is the only possible way to make the international interpretation and analyses of results consistent.

Translation is always a highly subjective operation. Therefore, it is no surprise that instruments that have already been translated in other languages and that have not been linguistically validated have caused concern to regulators worldwide, such as the EMA, regarding the validity of measuring the same concepts. With the enlargement of Europe, the need for the linguistic validation of translated documents for clinical studies becomes increasingly more acute. This is not only relevant to the diversity of official languages, such as standard French, Spanish, etc., within the EU’s borders, but also the diversity of community languages spoken by the cultural diverse populations of many EU Member States, such as Turkish as spoken in Germany, Arabic as spoken in France and Bengali as spoken in the UK. For a PRO / QoL instrument to be effective and useful as a means to collect data, it must be appropriate to each cultural, linguistic and ethnic group under investigation. Therefore, to compare results of a PRO / QoL tool across languages, it needs to undergo a process that ensures:

• that the language versions obtained are conceptually equivalent, both to the original instrument and to one another. Conceptual equivalence is achieved when the answers to the same questions reflect the same concepts and that these concepts are meaningful and relevant in each of the cultures and languages concerned.
• that the language versions demonstrate item equivalence. This is achieved when the semantic equivalence of each item in the tool survives translation across languages.
• that each language version is culturally relevant, acceptable and understandable to the target population
• that the language versions are psychometrically comparable.

There are three approaches to linguistic validation:

i)                    Where the instrument is developed in one language (e.g. US English) within one country (e.g. USA) and the instrument must be translated into one or several other languages.

ii)                   Where the instrument has been developed in a source language and inter-cultural relevance and conceptual equivalence have been considered in the development of the original questionnaire.

Where the instrument has been developed simultaneously in different countries and languages. In this case, a harmonisation process (not dissimilar from a typical SPC harmonisation in the EU) will be necessary.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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