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

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


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.

Publication types

  • Validation Study

MeSH terms

  • Clinical Trials as Topic*
  • Communication*
  • Culture
  • Decision Making
  • Humans
  • Internationality
  • Language*
  • Multicenter Studies as Topic*
  • Outcome Assessment, Health Care / methods*