THE IMPORTANCE OF MIGRATION ASSESSMENTS- ECOA TRANSLATIONS AND LINGUISTIC VALIDATION
Author(s)
Sweeney E, Kelley T
TransPerfect, New York, NY, USA
Presentation Documents
OBJECTIVES: As the use of clinical outcomes assessments (COAs) in global studies continues to increase, early collaboration between eCOA and linguistic validation providers becomes critical to the success of global initiatives. Early involvement of a linguistic validation partner in the eCOA migration process offers insight into migration issues that may not be present in the English version of the instrument, but if not identified, can lead to study delays as well as increased costs for the sponsor. METHODS: An examination was conducted of previous linguistic validation projects that included either newly developed eCOA instruments or pen/paper to eCOA migration. A comparison of various eCOA platforms, the corresponding issues, and details relating to migration solutions were assessed. RESULTS: Frequently, a line of text that is present in an eCOA platform (proprietary software, Excel, etc.) is coded such that it populates into the eCOA device in multiple locations. These segments are sometimes referred to as “computed text” and are commonly used for response options that repeat for multiple items of a questionnaire. While this may work adequately in English, many languages require a variance in the translation used based on the context of the item and/or response choice. While a pen/paper version may allow for these variances, the initial eCOA programming may not. The variance is only determined further into the linguistic validation process and presents challenges if the device requires re-programming. CONCLUSIONS: A migration assessment, separate from equivalency testing, allows for the eCOA and linguistic validation providers to assess the initial setup of the eCOA software. This assessment can determine whether system modifications are necessary to allow for the translations to properly be mapped and displayed. This additional step will also prevent study delays as well as quality issues as it allows issues to be addressed early and avoid later difficulties.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PRM174
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Multiple Diseases