Development of a Standardized Classification System for the Translation of Patient- Reported Outcome (PRO) Measures  Brief Measure of Psychological Well-Being   Catherine Acquadro1 | Katrin Conway2 |  Barbara Wolf2  | Asha Hareendran3 |  Isabelle Mear4 |Caroline Anfray2 | Axelle Nadjar4	PDF File
1 Hôpitaux de Paris, Paris, France 2 Mapi Research Trust, Lyon, France 3 Pfizer Ltd, Sandwich, UK 4 Mapi Research Institute, Lyon, France Keywords: classification of translations, PRO measures, linguistic validation, grading system, quality of translations, translation methodology

Introduction and objectives

Given the globalization of the evaluation of health care interventions, especially clinical trials, there is an increasing need to translate Patient Reported Outcome (PRO) measures for use in multiple countries. Regulatory agencies, especially the FDA, have clearly voiced their concerns about the validity of translations to measure the same concepts cross-culturally.1, 2 In its recent draft guidance on the use of PRO measures in the evaluation of medicinal products, the FDA recommends that “sponsors provide evidence that the methods and results of the translation process were adequate to ensure that the validity of the responses is not affected”.2 In other words, providing evidence that appropriate methods have been employed to develop translations has become a crucial step to demonstrate their conceptual equivalence with respect to the original and hence their validity.

The process of translating a PRO measure includes systematic methods involving various steps where each step adds to the level of confidence about equivalence with respect to the original. However there are different approaches to achieve this and there is much debate about which steps should be performed, what the content of these steps should be and what these should be called3. In addition to this, these steps are often not clearly documented and consequently it becomes difficult to assess the quality of a translation and have confidence in its conceptual equivalence with respect to the original.