OBJECTIVES: Translation of patient reported outcomes (PRO) measures is an essential component of the research methodology required when preparing for multinational clinical trials. One such measure is the Functional Assessment of Cancer Therapy-Thrombocytopenia 18 questionnaire (FACT-Th18), which evaluates the quality of life (QOL) of cancer patients with thrombocytopenia. METHODS: This study set out to linguistically validate the FACT-Th18 scale for use in China, Greece, Hong Kong, Japan, India, Israel, Korea, Taiwan and Thailand. The combined sample consisted of 160 patients (81 males/79 females) diagnosed with thrombocytopenia. Patient mean age was 46 years, and at the time of administration, 146 patients were receiving treatment. The sample consisted of patients who speak Arabic, Chinese- Traditional, Chinese-Simplified, Greek, Gujarati, Hebrew, Hindi, Japanese, Kannada, Korean, Malayalam, Marathi, Punjabi, Tamil, Telugu and Thai. The FACTTh18 was translated based on the established FACIT methodology. Patients completed the respective translated questionnaire corresponding to their primary language and then participated in a cognitive interview to determine if there were any problems with the translations or item content. Quantitative analyses were performed on the combined sample and participant comments were analyzed qualitatively in order to confirm the validity of the translations. RESULTS: During the translation process terms such as “petechiae”, “pinpoint bruising” and “platelet transfusions” proved difficult to translate. The FACT-Th18 translations proved relevant to patients from a wide range of countries and were well understood. Very few items required adjustment to translations as a result of pilot-testing. CONCLUSIONS: The FACT-Th18 demonstrated linguistic validity across all 16 languages. The translations are considered acceptable for PRO assessment in international research and clinical trials.

Arnold B, Dhar J, Parks-Vernizzi E, Debb S. Translation and linguistic validation of the fact-TH18 for use with cancer patients with thrombocytopenia worldwide. Value in Health. 2012;15(4):A236.

http://dx.doi.org/10.1016/j.jval.2012.03.1274