The purpose of this study was to translate and linguistically validate the FACT-EGFRI-18 scale into 22 languages - Arabic, Cebuano, Chinese (Simplified), Chinese (Traditional), French, German, Hebrew, Hungarian, Italian, Japanese, Korean, Malay, Polish, Portuguese, Russian, Romanian, Spanish, Tagalog, Tamil, Thai, Turkish, and Ukrainian for use in Belgium, Brazil, Canada, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Philippines, Poland, Portugal, Romania, Russia, Singapore, Spain, Thailand, Turkey, Ukraine, and USA. Methods The FACT-EGFRI-18 was translated based on the FACIT methodology: two forward translations, one reconciled version of the two forward translations, one back-translation into English, independent review, harmonization across languages, formatting and proofreading. Patients completed the FACT-EGFRI-18 questionnaire and participated in cognitive debriefing interviews to assess the relevance, understandability, and appropriateness of the translations. Qualitative analyses of subjects’ comments assessed the linguistic equivalence of each translated version. Results Total study sample consisted of 214 cancer patients (97 males and 117 females). The mean age of the sample was about 58 years. 199 patients were receiving treatment with EGFR inhibitors at the time of administration. The translated items were well understood by participants in each sample and were revised as needed if participants’ comments revealed misunderstanding of an item’s intended meaning. For example, the terms/phrases “embarrassed,” “irritated,” “skin condition,” “social life,” and “unattractive“ required alternative translation solutions to ensure cultural appropriateness, conceptual equivalence and harmonization in some languages. Conclusions The FACT-EGFRI-18 has demonstrated linguistic validity across 22 languages. The translations are considered acceptable for PRO assessment in international research and clinical trials.

Parks-Vernizzi E, Debb SM, Savic L, Arnold B. Translation and linguistic validation of the fact-EGFRI-18 for use with cancer patients worldwide. Value in Health. 2016;19(3):A159.

https://doi.org/10.1016/j.jval.2016.03.1475