WHEN SHOULD TRANSLATIONS OF CLINICAL OUTCOME ASSESSMENTS (COAS) BE CONSIDERED OBSOLETE? RECOMMENDATIONS FROM MAPI’S TRANSLATIONS LIFE EXPECTANCY WORKING GROUP

Author(s)

Giroudet C1, Salmassi L1, Prill M1, Berne C2, Berrou M1, Boudrot A1
1Mapi, Lyon, France, 2Mapi Research Trust, Lyon, France

OBJECTIVES:  In literature, it is currently admitted that a translation should be reconsidered every 30 years. In the field of clinical outcome assessments (COAs), the question of translation life expectancy or obsolescence has not been debated yet. However, several examples [(e.g., Nadjar et al. 2012; Kantzer et al. 2014) show that this question should be legitimately considered. The objective of this abstract is to present the recommendations of Mapi’s Translations Life Expectancy Working Group. METHODS:  A group of experienced project managers in COA translations was set up. The first objective of the group was to identify obsolescence factors leading to the decision of modifying existing translations. The second objective was to develop a grading system (major/minor revision needed), and to decide upon which methodology to apply to carry on the revision. RESULTS: The working Group has identified four types of obsolescence factors: translation is more than 10 years old at the time of the analysis, existence of outdated content in the translations (e.g., outdated examples, terms, or techniques because of evolutions of habits, language, or technology), initiation of spelling reforms in the target countries, and evolution of the content or the conceptual definition of the original version. According to the response to these elements (Yes/No), Mapi proposes a decision-tree with two different recommendations, i.e., revision needed/not needed. A revision will be qualified as major if the review of the translation detects evolutions in the target countries or in the original version. If the revision implies major changes of content (i.e., new examples, or new wording) tests on patients and/or clinician reviews will be required. Examples are presented. CONCLUSIONS:  Mapi’s Translations Life Expectancy Working Group is proposing recommendations to address the obsolescence of COA translations. If applied in a consistent manner, these recommendations may prevent major issues in global clinical trials.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PRM184

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Multiple Diseases

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