Objectives: A new PRO instrument (Injection Treatment Acceptance Questionnaire - ITAQ) was developed to measure patients' acceptance of treatments requiring subcutaneous injections rather than oral pills as the mode of administration. After the tool's content validity was determined via three rounds of qualitative interviews with 29 English (US) speaking patients at high cardiovascular risk, and psychometric properties were confirmed using 151 patients, the final English version of the I-TAQ was provided for cultural adaptation/linguistic validation. Our objective was to perform a cultural adaptation/linguistic validation of the questionnaire into 37 languages. Methods: The I-TAQ was translated into these languages: Afrikaans (South Africa), Arabic (Israel, Kuwait, Lebanon, Saudi Arabia, UAE), Catalan (Spain), Danish (Denmark), Dutch (Belgium, Netherlands), English (Canada, UK), Finnish (Finland), French (Belgium, Canada, Switzerland), German (Germany, Switzerland), Greek (Greece), Hebrew (Israel), Hungarian (Hungary), Italian (Italy, Switzerland), Korean (Korea), Norwegian (Norway), Portuguese (Brazil), Russian (Russia, Ukraine), Simplified Chinese (China), Spanish (Spain, US), Swedish (Sweden), Traditional Chinese (Hong Kong, Taiwan), Turkish (Turkey), and Ukrainian (Ukraine). Our process followed ISPOR Guidelines as outlined in the 'Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation”-two forward translations, one reconciled translation, and one back translation, then evaluation by cognitive interviews with patients with hypercholesterolemia who were native speakers of the target languages. Results: During the interviews, a few linguistic issues were identified, so minor adjustments were made. Specifically, adjustments were made for 'injection treatment' and 'health condition' in German, confusion with 'convenient' in Italian (IT) and Catalan (ES), and distinguishing between the answer options in Dutch (NL). Conclusions: The linguistic validation into these languages provides evidence that the I-TAQ can be used in multinational trials and clinical settings, as conceptual equivalence and cultural appropriateness were demonstrated.

Crane, A.L., A. Popielnicki, and R.J. Sanchez, Linguistic validation of the injection-treatment acceptance questionnaire (I-TA Q). Value in Health, 2016. 19(7): p. A391.

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