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

[Correction added after online publication 13-November-2008: Information on FDA requirements in Section I has been updated]vhe_471 430..440 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 trans-lation 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 aroundmethods 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 avail-able literature, and had multiple discussions to develop this report