First published in 1996 and adopted by the HealthMeasures family of measurement systems (Patient-Reported Outcomes Measurement Information System (PROMIS®); Quality of Life in Neurological Disorders (Neuro-QoL); NIH Toolbox; as well as the Critical Path Institute's PRO Consortium; the FACIT Translation and Linguistic validation methodology emphasizes a “universal” translation approach in order to achieve a single, valid translation for each language, designed to work across different countries that speak the same language. The universal approach provides several advantages to a country-specific approach that produces multiple same-language versions across different countries. These advantages include the following: (1) enables language subgroup comparison, without requiring a check on bias introduced by different translations (e.g., comparing Spanish-speaking groups in the United States to one another or to people in Spain or Latin America); (2) minimizes bias introduced by multiple, country-specific translations in a project or trial; (3) simplifies logistics and analysis of multinational clinical trials; and (4) facilitates survey administration in the case of migrating populations. In cases requiring a universal translation, the standard methodology is modified during the translation and review steps and in cognitive debriefing to include native linguists from each relevant country.
This is a more rigorous version of the double-back-translation method considered superior to single translation and translation by committee (Bonomi et al., 1996).
The process is summarized as follows:
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For each target language, the source is translated by two independent professional translators.
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Next, a third independent translator reconciles the two forward translations by choosing the better of the two forward translations and resolving discrepancies between them.
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This reconciled version is then back-translated blindly by a native English-speaking translator fluent in the target language.
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The developer reviews the back-translation for discrepancies from the source version and to assess equivalence with the source.
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Subsequently, an additional independent review/finalization is performed by a native speaking linguist and harmonization with other existing translations is conducted by the developer in conjunction with the linguist.
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Finally, the target-language version is pretested with patients in the country in which the language is spoken. If any items are found to be problematic by patients, their feedback allows for modifications in the translations and for indications of changes that may later be made to the original source document, an example of the decentering process (Lent, Hahn, Eremenco, Webster, & Cella, 1999).
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The Universal Approach: For languages native to multiple countries, representatives from each country work together in conjunction with FACIT to develop one version of an item valid for use in every country a language is spoken, rather than country-specific versions.
All items in the FACIT Measurement System undergo this methodology and FACITtrans is the only vendor authorized to translate and linguistically validate FACIT items. Permission to translate any FACIT item or measure should be obtained prior to undertaking this methodology. Contact us for more details. If permission has not been obtained, the item or scale will not be recognized as part of the FACIT measurement system.