Chair:
Diane Wild MSc
Director, Oxford Outcomes
Goal:
to increase the use of good research practices for adapting and translating PRO instruments from one language and culture to another
Background:
With the increasing internationalization of clinical trial programs, the need to translate and adapt PRO instruments for use in other than the source language has grown rapidly and continues to develop with the increasing involvement of new countries such as India and China in clinical trials. Most instruments are developed in English speaking countries, and therefore, need to be translated and adapted for use in other countries.
Full adaptation requires that the scaling and psychometric properties of the new language are also assessed. Comparability of language version is dependent on both conceptual equivalence and construct value equivalence, i.e. even if the translation is accurate, the target culture may place a different value on what is measured. This is particularly important to assess in multi-center clinical trials where data is pooled. There is also the issue of the reliability and validity of
The FDA is drafting PRO guidance. With respect to cultural and language adaptation, it recommends that sponsors provide evidence that the methods and results of the translation process were adequate to ensure that response validity is unaffected, i.e. not lost in translation.
The methodology for the process of translation and linguistic validation has been developing over the past decade, but the supporting evidence indicating the best methods and good research practices is still a work in progress/in development.
It is the TLV working group’s overall goal to increase the use of good research practices in the translation and linguistic validation of PRO instruments. To that end, we will spearhead the PRO Task Force: Good Research Practices on Changing Culture & Language of PRO Instruments Task Force. In 2005, the LTV WG published a paper with recommendations on how to translate PRO measures, upon which we will substantially build. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation published in
Value in Health, Vol. 8, Issue 2, 2005 pp 95-104.
http://www.ispor.org/workpaper/research_practices/PROTranslation_Adaptation.pdf
For progress on this initiative:
PRO Task Force on Good Research Practices for Changing Culture or Language of an Application
http://www.ispor.org/TaskForces/PROApplications.asp
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