Preparing for Multinational Clinical Trials: Translation and Cultural Adaptations of PRO Measures

Faculty

Benjamin Arnold, MA, Helena Correia

Course Description

Translation and cultural adaptation of patient reported outcomes measures is an important component of research methodology in preparation for multinational studies. In order to improve cross-cultural equivalence it is essential to consider the process by which an instrument is translated/adapted and validated. This module will cover: 1) types of cross-cultural equivalence in the context of data poolability and potential threats to validity if equivalence is not achieved; 2) translation methodologies which adhere to industry standards including examples and case studies related to specific steps and challenges; 3) use of qualitative research methods such as cognitive interviewing techniques to assess linguistic validity and cross-cultural equivalence of translated measures, including case studies and examples. The module will conclude with recommendations toward ensuring appropriateness and therefore comparability of data when dealing with research in multiple cultural contexts.