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 by the need to produce valid and reliable questionnaires in a multiplicity of languages within a short time frame. We present an eight-step protocol for rapidly translating a quality of life (QOL) questionnaire into multiple languages, and demonstrate the protocol's utility and effectiveness by evaluating the translations for reliability and validity. The rapid translation protocol represents a minimalist approach to QOL questionnaire translation. Although this minimalist approach is not considered a recommended methodology, it may represent a feasible mechanism for questionnaire translation under certain circumstances. Most 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 five bilingual respondents to establish language and cultural equivalence and review of the translation by and editorial review board. The translated instrument was performance tested in the target language country on a pilot population of patients to determine its reliability and validity. Based on the findings, the instrument was further refined for use in the clinical trial.