Published May 2009
Citation
Wild D, Eremenco S, Mear I, et al. 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 & Linguistic Validation Good Research Practices Task Force Report. Value Health. 2009;12(4):430-440.
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.
Keywords: adaptation, linguistic validation, multinational, pooling,
translation.
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