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
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 Abstr...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Izdatelstvo OKI
2018-05-01
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| Series: | Качественная клиническая практика |
| Subjects: | |
| Online Access: | https://www.clinvest.ru/jour/article/view/15 |
| Summary: | 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 Abstract. 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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| ISSN: | 2588-0519 2618-8473 |