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.
OBJECTIVE
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.


CONCLUSIONS
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.
Wild
Diane
D
Oxford Outcomes Ltd, Oxford, UK. diane.wild@oxfordoutcomes.com
Eremenco
Sonya
S
Mear
Isabelle
I
Martin
Mona
M
Houchin
Caroline
C
Gawlicki
Mary
M
Hareendran
Asha
A
Wiklund
Ingela
I
Chong
Lee Yee
LY
von Maltzahn
Robyn
R
Cohen
Lawrence
L
Molsen
Elizabeth
E
D002986:Clinical Trials as Topic; D003142:Communication; D003469:Culture; D003657:Decision Making; D006801:Humans; D038622:Internationality; D007802:Language; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care / Q000379:methods*