Objectives: The Patient Reported Outcomes Measurement Information System (PROMIS®) comprises highly reliable, precise measures of patient-reported physical, mental, and social health. PROMIS instruments are ideally suited to become fit for purpose clinical outcome assessments for regulatory review across a range of therapeutic areas. Multilingual translations of the PROMIS Physical Function (PF) items will enable international studies. The objective of this presentation is to report on a sample of PF translations, discuss issues arising from linguistic validation across multiple languages, and provide an outlook for opportunities to use PROMIS PF items in future research. Methods: Selected items from the PF domain were translated into Arabic, Simplified Chinese, French, Hungarian, Italian, Russian, and Ukrainian according to FACIT translation methodology. The translations were tested with five native-speaking participants from each target language. Subjects completed the PF items and participated in a cognitive debriefing interview to assess the relevance, understandability, and appropriateness of the translations. Qualitative analyses of subjects' comments assessed the equivalence of each translated version. Results: Translated items were well understood by participants in each sample. Translations were revised as needed, if participants' comments revealed misunderstanding of an item's intended meaning. For example, terms like “flight of stairs” and “changing a lightbulb overhead” required alternative translation solutions to ensure cultural appropriateness, conceptual equivalence and harmonization across languages. Conclusions: Translated PF items are conceptually equivalent to the English source version and can be used in research, multinational trials, and clinical practice.A selection of items is now available in Arabic, Simplified Chinese, French, Hungarian, Italian, Russian, and Ukrainian. The complete PF item bank has been translated into Spanish, Dutch-Flemish, Danish, German, and Portuguese, and cross-language issues pertaining to those languages will be reported elsewhere. Future research could include validation studies and calibration of item banks in each language.

Parks-Vernizzi, E., et al., Promis® physical function multilingual translations: Progress and outlook. Value in Health, 2015. 18(7): p. A744-A745.

http://dx.doi.org/10.1016/j.jval.2015.09.2870