Galen Research Ltd have considerable experience in adapting PRO measures for use in new languages – having translated and linguistically validated more than 30 measures into over 60 European, Asian, African, Australian, and North and South American languages in a wide range of therapeutic areas. Galen works to the very highest standards and in compliance with FDA guidelines.
The objective in adapting questionnaires is to ensure that items are understood in the same way in different languages. It is also important that (as far as possible) each item represents a similar level of severity across different countries and cultures.
Galen Research does not employ backward-forward translation as this method has been shown to have problems – especially when there are major differences in culture between two countries. We adopt the dual panel methodology1 to produce new language versions of measures. Two panels are conducted in the target country; a bilingual panel (to provide the initial translation into the target language) and a lay panel (where items are assessed by people of average and below average education levels for comprehension and “naturalness” of language). Cognitive debriefing interviews are conducted to test the applicability, relevance and comprehensiveness of the new measure with target respondents.
It is also highly recommended that the new versions are tested for scaling and other psychometric properties. The FDA requires that new language versions of PROs are shown to match the original language version. The only valid way to do this is be running a test-retest validation study and applying Rasch analysis to the data collected. However, we acknowledge that organisations that employ forward and backward translation rarely test the resulting questionnaire.
Research has shown that patients prefer translations that are produced by the two panel methodology to those using forward and backward translation [2].
Galen Research has developed a team of international experts to assist us in the development of new language versions of PROs. These range from quality of life experts in academia through to clinicians, health care authorities and independent researchers who add expertise of local languages and cultures to our adapted measures.
References
Hunt SM, Alonso J, Bucquet D, Niero M, Wiklund I, McKenna SP. Cross-cultural adaptation of health measures. Health Policy 1991; 19: 33-44
Hagell P, Hedin P-J, Meads DM, Nyberg L, McKenna SP Effects of Method of Translation of Patient-Reported Health Outcome Questionnaires: A Randomized Study of the Translation of the Rheumatoid Arthritis Quality of Life (RAQoL) instrument for Sweden. Value in Health 2010; 13: 424-30.