METHODS FOR ADDRESSING USE OF PRO INSTRUMENTS IN THE SAME LANGUAGE FOR DIFFERENT COUNTRIES- BEST PRACTICE GUIDELINES FOR DECISION-MAKING AND TRANSLATION OR ADAPTATION

Author(s)

Sonya Eremenco, MA, ePRO Manager1, Caroline Houchin, MA, Senior Translation and Linguistic Validation Coordinator2, Mary Gawlicki, MBA, President3, Lee Yee Chong, BScPharm, PhD, Research Associate41United BioSource Corporation, Bethesda, MD, USA; 2 Oxford Outcomes Ltd, Oxford, Oxon, United Kingdom; 3 Corporate Translations, Inc, East Hartford, CT, USA; 4 NCC-AC, Royal College of Surgeons, London, United Kingdom

OBJECTIVES: The 2005 report of the ISPOR Task Force that studied Translation and Cultural Adaptation left several questions unanswered. Recently the Task Force completed a new report in which it explored topics not addressed in its previous work.  Among the topics studied was the issue of how to approach the creation of a PRO instrument when the same language is required for use in different countries. The objective of this investigation was to develop a method for determining which of these suggested approaches is best suited to any particular situation by looking at key aspects of the questionnaire and the languages involved, and, once the approach is identified, to describe in detail the methods for carrying out the selected approach.   METHODS: A literature review was conducted to investigate existing guidelines and approaches used to address the same language in different countries. RESULTS: Based on the literature review and our practical experience, three primary approaches were identified and investigated: country-specific translation, same language adaptation, and universal translation, as well as many combinations of all three approaches. This new research developed a decision making tool and scenarios illustrating the process for choosing and then translating or adapting an instrument using each of the three methods.   CONCLUSIONS: The Task Force developed recommendations for choosing a suitable approach for commonly encountered situations in the form of a decision-tree flowchart as well as best practice guidelines for how to carry out each of the three suggested approaches.

Conference/Value in Health Info

2008-11, ISPOR Europe 2008, Athens, Greece

Value in Health, Vol. 11, No. 6 (November 2008)

Code

PMC32

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Multiple Diseases

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