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…
By D. Wild, S. Eremenco, I. Mear, Mona Martin, C. Houchin, M. Gawlicki, A. Hareendran, I. Wiklund, Lee Yee Chong, R. von Maltzahn and 2 more. Value in Health, 2009
295 citations recorded by the source corpus.
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.
Subfields: Oncology, Public Health, Environmental and Occupational Health, Statistics and Probability
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Citations in the corpus
- ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research (2013, methodology): “[31] Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data Expert opinion and literature review Provides decision tools to decide on translation required for PRO measure; approac”