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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
Open accessAbstract
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.
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Metadata
- Authors
- Wild, D., Eremenco, S., Mear, I., Martin, M., Houchin, C., Gawlicki, M., Hareendran, A., Wiklund, I., Chong, L. Y., von Maltzahn, R., Cohen, L., & Molsen, E.
- Venue
- Value in Health
- Publisher
- Elsevier BV
- Published
- 2009-06
- Volume
- 12
- Issue
- 4
- Pages
- 430-440
- ISSN
- 1098-3015 (ISSN-L)
- OpenAlex
- W2171677789
- Cited by
- 323
- References
- 24
- FWCI
- 9.86
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Wild, D., Eremenco, S., Mear, I., Martin, M., Houchin, C., Gawlicki, M., Hareendran, A., Wiklund, I., Chong, L. Y., von Maltzahn, R., Cohen, L., & Molsen, E. (2009). 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. Value in Health. https://doi.org/10.1111/j.1524-4733.2008.00471.x
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