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Value Health. 2009 Jun;12(4):430-40. doi: 10.1111/j.1524-4733.2008.00471.x. Epub 2008 Nov 12.

Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force report.

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1
Oxford Outcomes Ltd, Oxford, UK. diane.wild@oxfordoutcomes.com

Abstract

OBJECTIVES:

With the internationalization of clinical trial programs, there is an increased need to translate and culturally adapt patient-reported outcome (PRO) measures. Although guidelines for good practices in translation and linguistic validation are available, the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Task Force identified a number of areas where they felt that further discussion around methods and best practices would be beneficial. The areas identified by the team were as follows: 1) the selection of the languages required for multinational trials; 2) the approaches suggested when the same language is required across two or more countries; and 3) the assessment of measurement equivalence to support the aggregation of data from different countries.

METHODS:

The task force addressed these three areas, reviewed the available literature, and had multiple discussions to develop this report.

RESULTS:

Decision aid tools have also been developed and presented for the selection of languages and the approaches suggested for the use of the same language in different countries.

CONCLUSION:

It is hoped that this report and the decision tools proposed will assist those involved with multinational trials to 1) decide on the translations required for each country; 2) choose the approach to use when the same language is spoken in more than one country; and 3) choose methods to gather evidence to support the pooling of data collected using different language versions of the same tool.

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