RAPID TRANSLATION OF QUALITY-OF-LIFE MEASURES FOR INTERNATIONAL CLINICAL-TRIALS - AVOIDING ERRORS IN THE MINIMALIST APPROACH

There is a growing demand for tools to assess outcomes multinationally for use in international clinical trials. This has been accompanied b y the need to produce valid and reliable questionnaires in a multiplic ity of languages within a short time frame. We present an eight-step p rotocol for rapidly translating a quality of life (QOL) questionnaire into multiple languages, and demonstrate the protocol's utility and ef fectiveness by evaluating the translations for reliability and validit y. The rapid translation protocol represents a minimalist approach to QOL questionnaire translation. Although this minimalist approach is no t considered a recommended methodology, it may represent a feasible me chanism for questionnaire translation under certain circumstances. Mos t of the steps were completed in the USA, including a translation and back-translation by bilingual translators who were native speakers in the target-language, a test-retest of the translated instrument on fiv e bilingual respondents to establish language and cultural equivalence and review of the translation by an editorial review board. The trans lated instrument was performance tested in the target language country on a pilot population of patients to determine its reliability and va lidity. Based on the findings, the instrument was further refined for use in the clinical trial.